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BACKGROUND OF THE INVENTION Conventional techniques and games providing the aura of football and field goals are of interest as a result of the heavy emphasis placed upon the game of football. Conventional games involve the use of conventionally shaped devices and objects which require little experience before maximum skill is attained thus causing their interest span to be relatively short. SUMMARY The present invention contemplates utilizing a non-conventionally shaped "football" to be used in the game which requires more skill than usually thus lengthening its interest span and yet forgives a lack of skill sufficiently to make the game interesting and enjoyable. It is therefore an object of the present invention to provide a football game device and football which provides a challenge with respect to skill and also forgives a lack of skill sufficiently to allow interest and enjoyment to remain. A further object of the present invention is to provide such a device which is comprised of a playing board provided with football field indicia thereon, goal posts mounted thereon, a football shaped in the form of a conventional match book or partially flattened paper band and a marker device. A further object of the present invention is to provide such a device which is simply and economically manufactured and used. These together with other objects and advantages which will become subsequently apparent, reside in the details and construction and operation as more fully hereinafter described and claimed, reference being had to the accompanying drawings forming a part hereof, wherein like numerals refer to like parts throughout, and in which; BRIEF DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 is a perspective view of a portion of the football field goal device constructed in accordance with and embodying the present invention. FIG. 2 is a perspective view of a football used with the device in FIG. 1. FIG. 3 is a perspective view of another football used with the device in FIG. 1. DETAILED DESCRIPTION OF THE INVENTION Referring now in more detail and by reference characters to the drawings which illustrate practical embodiments of the present invention, FIG. 1, and FIG. 2, are perspective views of a football game device, 1, constructed in accordance with, used in and embodying the present invention. As shown in FIG. 1, and FIG. 2, device, 1, comprises playing board, 2, provided with football field indicia, 3, marked thereon, goal post means, 4, mounted on board, 2, marker means, 5, and football, or projectile means, 6, in the shape of a conventional match book cover. An alternate football, 7, is shown in FIG. 3. Typically, the footballs would be constructed of materials as cardboard or the like and would be sized of the order of a conventional match book cover. A typical method of playing the game or the rules regulating the game are as follows: A touchdown is 6 points, a kick after is 1 point, a field goal is 3 points, a safety is 2 points, a game winner is an automatic 21 points. The object of the game is to be the first person to obtain 21 points or more. To score a touchdown the following must happen; the ball, 6, is placed in a designated area which would typically be the area short of a particular yard line, such as the 20 yard line or 40 yard line, and would be varied dependent upon the age and skill of the players, then it is hit, pushed or flipped across the playing field, 2, and must stop in a touchdown area designated on board, 2 which would typically be the end zone. The force impelling the ball, 6, is from the finger of the player. If the ball passes over the end of the board, 2, the opponent places the ball, 6, in his designated area and trys for a touchdown. If a player scores a touchdown then he is entitled to try for an extra point from a designated spot on the board, 2. The player then attempts to impel the ball, 6, between the uprights, 8, and, 9. If the ball comes up short of the touchdown area or end zone when attempting a touchdown an opponent may play from that spot and attempt a touchdown, field goal, or safety. A safety is obtained by trying for a touchdown and coming up a "little short". A "little short" is determined by marker, 5. If the ball is completely within a distance equal to the width of space, 10, on marker, 5, of the touchdown area or goal line, then safety is scored. Following a safety the scorer may try for another safety or a touchdown. A "game winner" is obtained by causing the ball, 6, to land in an area marked on the field, 2. Other provisions may be made for balls travelling out of bounds, etc. Time limits may be placed upon the players taking their turns. Considerable skill is required using a ball, 6, as contemplated herein in order to cause them to travel a desired distance as well as to cause them to fly, sail or soar so that it can be caused to pass between uprights, 8, and, 9. It should be understood that changes and modifications in the form, construction, arrangement, and combination of the football game device and methods of making and using the same may be made and substituted for those herein shown and described without departing from the nature and principle of my invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] NONE STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Research and development of this invention and Application have not been federally sponsored, and no rights are given under any Federal program. REFERENCE TO A MICROFICHE APPENDIX [0003] NOT APPLICABLE BACKGROUND OF THE INVENTION [0004] 1. Field of the Invention [0005] This invention relates to hanging package products for displaying items for retail sale, in general, and to a self-contained hanging package particularly attractive for the display sale of confectionery, and wet or dry form cosmetics, in particular. [0006] 2. Description of the Related Art [0007] Hanging package products for display sales generally consist of carded packagings where such goods as toys, hardware, and electrical items are contained between a specially made paperboard card and a clear pre-formed plastic shells, typically of polyvinylchloride. Allowing a consumer to easily examine the product through the transparent plastic, the plastic shell is typically vacuum-formed around a mold to contain the item snugly. The card is usually brightly colored and designed depending on the item inside, and the polyvinylchloride is affixed to the card using heat and pressure to activate an adhesive to form a heat seal coating on the card. Oftentimes, referred to as blister packs, the adhesive employed is selected strong enough so that the pack may hang on a peg, but weak enough so that the package can be easily opened. Sometimes with large items, the card has a perforated window for access to allow the item inside to be more easily removed. [0008] As will be readily appreciated, however, these hanging package units, in construction, embody two separate products—the item itself, and the package which surrounds it. Frequently, the package is designed to be difficult to open by hand so as to deter tampering. With this, as with the simpler version of allowing easy access to the item inside, once the package is opened and the plastic shell discarded, there is little that can be done to recover the item for future use, resulting in the wasting of the extra materials employed. OBJECTS OF THE INVENTION [0009] It is an object of the present invention to provide a new and unique hanging package product for display unit sales which overcomes this disadvantage of the prior art. [0010] It is an object of the present invention, also, to provide such a hanging package product in which the item inside and the clear plastic shell are formed together as a self-contained construction. [0011] It is another object of the invention to provide a hanging package product of this nature which is particularly attractive for the display sales of confectionery, and wet or dry form cosmetics. [0012] It is a further object of the invention to provide this confectionery and cosmetic hanging package product which is both tamper resistant in opening, but able to be closed off to save any remaining product after a partial draining of its contents. [0013] It is yet another object of the invention to provide this hanging package product for display unit sales in which the product content can be released by a simple squeezing of the plastic shell itself. SUMMARY OF THE INVENTION [0014] As will become clear from the following description, the tamper resistant self-contained hanging package of the invention is formed of three unique components—a bladder, a cap, and a sealing card. The bladder component will be seen to be fabricated of a squeezable plastic, preferably flat on one side, and fillable with any type of confectionery, and wet or dry form cosmetic. The cap component will be seen to be provided with “ears”—which, when the package is ready to be opened, are turned to both open the cap and separate it from a nozzle of the bladder. The sealing card component will be seen to be die cut, with an outer layer of cardboard and an inner layer of plastic for not only supporting the finished product, but to be foldable to allow the bladder and all interior areas of the card to be heat sealed together. Designed with a “tear-corner”, the only way to access and dispense the product contents will be seen to be a ripping of this corner which, at the same time, opens the cap and removes it from the bladder nozzle. Fabricating the ripped “tear-corner” to be easily removable from the cap, furthermore, allows the cap itself to be thereafter attached to the nozzle in closing off the bladder to save any remaining content for later use. BRIEF DESCRIPTION OF THE DRAWINGS [0015] These and other features of the invention will be more clearly understood from a consideration of the following description, taken in connection with the accompanying drawings, in which: [0016] FIGS. 1 a - 1 e are perspective and/or sectional views of the bladder component of the self-contained hanging package in a preferred embodiment of the invention; [0017] FIGS. 2 a - 2 f are perspective, sectional and other views of the cap component of the preferred hanging package invention; [0018] FIGS. 3 a - 3 b are outer and inner views of the sealing card component of the invention; [0019] FIGS. 4 a - 4 d are views helpful in understanding the forming of the bladder, the cap, and the sealing card into the self-contained hanging package of the invention; and [0020] FIGS. 5 a - 5 c and FIGS. 6 a - 6 c are views helpful in appreciating modifications that can be made in constructing alternative embodiments of the invention. DETAILED DESCRIPTION OF THE INVENTION [0021] The bladder component 10 of the self-contained hanging package is fabricated from a soft and squeezable material, enabling a user to easily dispense and squeeze out its contents—such as confectionery, and wet or dry cosmetic products. In the preferred embodiment depicted in FIGS. 1 a - 1 e, the bladder is fabricated of a low density, squeezable polyethylene formed as a half unit—its top 12 being shown in the front perspective views of FIGS. 1 a, 1 b, and 1 c, and in the sectional view of FIG. 1 d, as “domed”, and its bottom 14 as shown in the bottom perspective view of FIG. 1 e as a flat base. A nozzle of the bladder is shown at 16 , centered on the bladder 12 , with the nozzle 16 pointed upwardly in FIG. 1 a and downwardly in FIG. 1 c. In particular, the top half 18 of the nozzle 16 is located at the top of the bladder 12 (as shown in the sectional cut view of FIG. 1 d ), with the bottom half 20 of the nozzle 16 being located at the flat base of the bladder in that sectional cut view. As shown in the bottom perspective view of FIG. 1 e with the nozzle 16 pointing downwardly, the nozzle area 22 is convex so as to allow the opening of the nozzle to remain in full circle. The nozzle 16 is threaded at 24 so as to screw with the cap component illustrated in the views of FIG. 2 . A pair of stoppers 26 , 27 are shown on the nozzle 16 in FIG. 1 e to match up with the sealing card, to be described in the views of FIG. 3 . Reference numeral 28 illustrates an opening in the nozzle 16 for the filling of the wet or dry product content. Reference numeral 30 identifies a thin edge of the bladder 10 to allow the bladder to easily seal to the sealing card of the FIG. 3 views by sandwiching between its layers. [0022] As an appreciation of the views of FIGS. 2 and 3 will illustrate, the stoppers 26 and 27 are in the shoulder of the nozzle 16 , and essentially comprise two small points which stop the cap from unlimited rotation when the cap is screwed onto the nozzle; this allows the cap ears to be described below to be parallel with the sealing card. At the same time, the thin edge 30 which frames the bladder 10 will be seen to seal the bladder to an inner wall of the sealing card. As will be described with respect to the views of FIG. 3 , once the bladder 10 is filled, and the cap of the views of FIG. 2 is affixed, the bladder 10 is dropped into the open “sealed card”, facing the inner layer. The card is then folded closed and the card and bladder are heat sealed together. [0023] The cap component 35 of the hanging package is illustrated in the various views of FIG. 2 . Specifically, FIG. 2 a is a front view of the cap, FIG. 2 b is a perspective view of the cap with its bottom 37 facing downwardly, FIG. 2 c is a perspective view of the cap showing its top surface 39 , FIG. 2 d is a bottom view of the cap, FIG. 2 e is a perspective view of the cap with its bottom facing upwardly, and FIG. 2 f is a sectional view of the cap showing its internal structure. As previously mentioned, the cap 35 screws onto the nozzle 16 of the bladder at 24 by way of threads 41 within the cap bottom 37 . Preferably, the cap is fabricated of polypropylene. [0024] Reference numerals 43 and 45 identify extensions on opposite sides of the cap allowing the cap 35 to be fixed into a corner 85 of the sealing card illustrated in the views of FIG. 3 . These extensions (or “ears”), more specifically, are sealed into a top corner of the card, sandwiched between its inner and outer layers. Being so hidden within the card once sealed into it, the ears 43 , 45 cannot be seen from the front or back of the card—but when the package is ready to be opened by the user ripping the top corner 85 from the card, the ears that are extended within are turned as well, and will open the cap in separating it from the nozzle of the bladder. The corner and cap that are together can then easily be separated from one another by breaking the meeting points or tearable perforations between them. Once the cap is separated, the cap ears are exposed but the cap can be screwed back onto the nozzle to close the remaining contents of the bladder for later use. [0025] In this respect, inside the cap 35 are a pair of stoppers 47 , 48 on a track 49 with a raised edge located on both sides of the cap ( FIG. 2 c ). Such stoppers 47 , 48 operate in conjunction with the stoppers 26 , 27 of the nozzle 16 ( FIG. 1 e ) in allowing for the ears 43 , 45 to be parallel with the bladder 10 and the sealing card of the FIG. 3 views. An inner plug 51 on the cap 35 ( FIG. 2 f ) seals the opening of the nozzle 16 as the cap 35 is screwed onto the nozzle. In effectuating this, the plug 51 is slightly tapered so as to be forced into the nozzle 16 in sealing off the nozzle. [0026] The sealing card support component 75 of the hanging package of the invention is composed of an outer cardboard layer 60 ( FIG. 3 a ) and an inner polyethylene layer 62 ( FIG. 3 b ). The outer cardboard side is printed at 64 with related information and advertising and serves as a support for the hanging package. The inner layer 62 , on the other hand, is to be heat sealed both to the bladder 10 , and to itself once folded over. Those areas identified by the reference numeral 66 together form a Euro hole for hanging the card once the card is folded over upwardly, and preferably in half, along a fold line 68 and sealed. The areas identified by the reference numerals 70 , 72 are die cut to receive the front and back of the bladder nozzle 16 , respectively, when the bladder is dropped into the card. Those areas shown by the reference numerals 74 , 76 are die cut to receive the front and back of the bladder 10 , respectively. With the card of FIGS. 3 a and 3 b folded over in half, with the framing edge 30 then abutting the inner layer 62 , and with all of the meeting materials being of a form of polyethylene (with the exception of the cap) so as to be heat sealable together, the bladder 10 and all interior areas of the card can be sealed. [0027] Reference numeral 78 in FIG. 3 b identifies an embossed edge for the dropped-in placement of the bladder 10 , while that area identified by the reference numeral 80 represents a debossed area in FIG. 3 a . The embossed area 78 aligns the bladder's edge 30 of FIGS. 1 a, 1 b or 1 c, as well as the cap ears 43 , 45 of the card. Such areas 78 , 80 allow the card to be better sealed, as the thickness from the bladder's edge 30 and the cap ears 43 , 45 are absorbed by the embossing of the card. With a finish of the card being flat and even all around, and with all edges of the card being sealed, it will be appreciated that the only way to access the product is by tearing away the top corner 85 of the card. A tear line 87 is shown in FIGS. 3 a and 3 b , along with tearable perforations 89 which attach to the cap ears 43 , 45 . In particular, the perforated area 85 once given a rotational twist tears away from the card layers 60 , 62 ; and, at the same time opens the cap ears 43 and 45 to separate the cap 35 from the bladder 10 . Such tamper-resistant feature of the hanging package is supplemented through a further easy removal of the cap from the card so that the cap can then be fixed to the bladder without the torn corner, for later use. This follows from the cap being then tearable away from the perforations 89 . Moreover, the cap is additionally fabricated from polypropylene, so as not to be sealed with the inner polyethylene layer of the card 62 . In this respect, fabricating the layer 62 of a polyethylene allows that lamination of the card to be sealed to the thin edge 30 of the bladder, while leaving the outer layer 60 of the card as a standable, printable paper-type or cardboard-type board of any desired specific weight. [0028] FIGS. 4 a - 4 d are helpful in appreciating how the self-contained card hanging package of the invention may be formed. In particular, FIG. 4 a is an exploded view of all components of the package, FIG. 4 b is a partially assembled view of the bladder, cap and sealing card components, FIG. 4 c is a front view of all the parts assembled, and FIG. 4 d is a back view of all the assembled parts. The bladder 10 with its bottom 14 and its nozzle 16 is illustrated in FIG. 4 a , as is the cap 35 with its ears 43 , 45 . So too, is the embossed edge 78 on the inside card polyethylene layer 62 with the tear line 87 and its tear point perforations 89 . FIG. 4 b shows the bladder 10 dropped into the polyethylene inner layer 62 , with the outer layer 60 being folded over the bladder to the inner layer 62 by rotating the bottom portion of the card upwardly. (Once this is done, the card is then heat-sealed all around in locking the bladder into the card.) With FIG. 4 c showing a front view of the heat sealed card when closed in full assembly, the tear corner 85 is at the upper right (or at the upper left in the back view of the assembled parts as viewed in FIG. 4 d .) When so folded over and assembled, the soft and squeezable “dome” 12 of the bladder 10 is displayed on the package front, the remaining space 90 being utilizable for additional printing and advertising. The back of the sealed card viewed in FIG. 4 d shows the bladder nozzle 16 being exposed, along with the area 64 on which the printing and product advertising is illustrated. A self-contained squeeze card hanging package thus results. [0029] When so assembled, the perforated area all the way through the top corner of the card, when twisted or torn in a counterclockwise position, tears open the card in allowing the cap 35 to be removed. The torn off cardboard corner and cap can be easily separated, and the cap replaced upon the bladder's nozzle 16 so that the remaining product can be accessed at another time. This follows, since the ears 43 , 45 allow the cap 35 to turn while the corner is being torn from the card—but since the cap 35 is made of polypropylene rather than polyethylene (i.e., another material), the cap 35 will not seal to the card. Once the cap 35 is removed from the nozzle 16 , the contents of the bladder—whatever it may be—can be squeezed and sucked out (or just squeezed out) the nozzle opening simply by pressing down on the low density polyethylene bladder. Once the bladder is emptied, the bladder can simply be discarded. [0030] Whereas there has been described what is considered to be a preferred embodiment of the invention, it will readily be appreciated that modifications can be made by those skilled in the art without departing from its teachings. For example, while the preferred embodiment has been described with a single product containing bladder, double chambered bladders with nozzles 90° apart can be located at both the left and right corners of the card, as well. Likewise, the bladder design can be of amy geometric or freeform shape—all as shown in, for example, the single chamber splodge of FIG. 5 a , the single chamber star of FIG. 5 b , and the double chamber freeform of FIG. 5 c , each with its own tear-away corner and capped ears sandwiched between the inner polyethylene layer and the outer cardboard layer of the sealing card. In similar manner, the cap component can be changed over to a sprayer-type component to provide a spray version of the invention—as shown in the front view, back view, and assembly view of FIGS. 6 a , 6 b and 6 c where reference numeral 200 identifies the Euro hole for hanging, reference numeral 201 represents the cap with its ears centered between the two panels of the card, with the tear points to open the card and free up the cap being shown at 202 , with a sprayer down tube shown at 203 , with the bladder sealed to the inside of the card shown at 204 , with the tear away portion of the card shown at 205 , with the back-side cardboard for printing and advertising shown at 206 , with the top portion of the card being torn away and discarded at 207 , with the cap being removed from the top portion of the card and replaceable onto the sprayer as at 208 , with the spray nozzle at 209 , and with a screw-on closure attached to the spray end assembly as at 210 . In each arrangement of the views of FIGS. 5 and 6 , the squeezable bladder can be filled with any type of product—whether it be confectionery, or cosmetic of wet or dry form. [0031] And, as yet another feature and modification of the invention, instead of having the bladder component 10 essentially of a clear composition to allow a consumer to easily view its contents, the bladder portion can be printed or decorated with whatever images may be desired in resembling characters, scenes or topological features for example—and with or without the bladder having a flat base bottom. As will be understood, however, by having a flat base bottom instead of one which is convex, the ease of printing the back of the sealing card with backgrounds, advertising, and information becomes not only simpler, but allows for greater informational content. [0032] For at least the foregoing reasons (and for the further reason that the squeezable bladder can contain a wide type of flowable product contents other than confections, or cosmetics), resort should be had to the claims appended hereto for a true understanding of the scope of the invention.

1a

BACKGROUND OF THE INVENTION The present invention relates to a process for the preparation of milk concentrates and milk powders having a long storage life utilizing techniques which are known per se. By bringing milk into a concentrated form or into a powder form and subjecting it to one or more heat treatments and to an aseptic packaging method, not only its storage life is prolonged but also the cost of transport is limited. For use, the concentrated or powdered milk product can be recombined or reconstituted. In the case where in particular unsaturated fatty acid-containing compounds are present, however, the process of fat decay or `turning rancid` develops relatively easily and rapidly with milk concentrates and milk powders. This process of turning rancid gives rise to deteriation of the taste and problems of uptake and easily leads to problems of indigestion, in particular in sensitive individuals. More particularly, this problem occurs with milk products which have been enriched with unsaturated fatty acid derivatives or in which the milk fat has been replaced completely with these derivatives. Examples of such unsaturated fatty acid derivatives include fats, phospholipids or emulsifiers which contain a high percentage of unsaturated fatty acids and/or strongly unsaturated fatty acids. Enrichment of milk and milk powders with unsaturated fatty acid-containing phospholipids or emulsifiers is done for technological or physiological reasons. An important reason for enriching milk or milk powders with fats containing a high percentage of unsaturated fatty acids or strongly unsaturated fatty acids is to prevent or reduce cardiovascular diseases, atopies, rheumatic disorders or diabetes. In particular, such products contain a high percentage of oleic acid, linoleic acid which may or may not be conjugated, α-linolenic acid and unsaturated C 20 and C 22 fatty acids. Thus, to prepare food for premature children the fat fraction of milk concentrates or milk powders is enriched with strongly unsaturated fatty acids of the type C 20 ω-6 and C 22 ω-6+C 20 ω-3 and C 22 ω-3. These fatty acids are typically denoted by the name of LC-PUFAS, which is an abbreviation of "Long Chain poly-Unsaturated Fatty Acids". Examples of LC-PUFAS include: C 18 :3ω6 (γ-linolenic acid; GLA), C 20 :3ω6 (dihomo-γ-linolenic acid), C 20 :4ω6 (arachidonic acid; AA), C 18 :4ω3 (octadecatetraenoic acid), C 20 :5ω3 (eicosapentaenoic acid; EPA), C 22 :6ω3 (docosahexaenoic acid; DHA or DCHA). LC-PUFAS are preferably included in the fat fraction of food for premature children together with the biochemical precursors C 18 :2ω6 (linoleic acid) and C 18 :3ω3 (α-linolenic acid). The reason for this is that the biochemical conversion of the precursors by desaturase and elongase enzymes proceeds only suboptimally in premature infants. LC-PUFAS, such as GLA, AA, EPA and DHA, are incorporated in particular in the fat fraction of food for premature infants because these fatty acids are of importance for optimum structuring of the cell membranes. Biochemical conversions may also proceed suboptimally in non-premature infants. This is in particular a medically recognized problem with the conversion of linoleic acid to γ-linolenic acid (GLA) in elderly people. The fat fraction of milk or milk powders is then enriched with unsaturated fatty acids of the type GLA. From the prior art, for instance European patent application 0 404 058, it is known to avoid the problem of unsaturated fatty acid-containing products turning rancid by adding to them antioxidants, such as α-tocopherol, optionally together with an emulsifier, such as lecithin, and/or by gassing these products with, for instance, nitrogen gas and/or carbonic acid gas and subsequently storing them under this inert gas. SUMMARY OF THE INVENTION According to the invention, an improved method has now been found for preventing unsaturated fatty acid-containing products turning rancid. When a fat fraction containing strongly unsaturated fatty acids with an unstable character is added to the milk liquid to be concentrated only on one of the effects of the evaporator instead of being mixed with the milk liquid prior to the start of the evaporation step, the concentrated or powdered product acquires an improved storage stability. The process for the preparation of milk concentrates and milk powders having a long storage life by conventional techniques whereby a milk liquid is prepared which is minimally evaporated with an evaporator, is characterized according to the invention in that a fat fraction containing unsaturated (free) fatty acids is added to the milk liquid in one or more effects, or stages, of the evaporator. Concentrated milk and milk powder obtained by the use of the process according to the invention have a prolonged storage life. In accordance with the invention the fat to be added is metered during the evaporation in one or more of the effects of the evaporator. All this also simplifies the conduct of the process because less liquid needs to traverse the complete course of the evaporator and mixing capacity can be saved on. This is a second advantage of the process according to the invention. Because of the last-mentioned advantage it is most advantageous to add the fat under the downpipes for the liquid collector of the last effect of the evaporator. However, the addition can take place in the way indicated in any effect of the evaporator. U.S. Pat. No. 1,432,633 discloses an obsolete process for the preparation of a milk product which is composed of milk from which substantially all of the butter fat has been removed, and vegetable oils which are free of free fatty acids. The objective underlying this old patent is to provide a milk product of excellent flavor, the fat fraction being constituted by relatively inexpensive vegetable fat. The relatively costly animal fat can thus be made available for other uses. The milk product described can be partially condensed. Such partial condensation occurs discontinuously using a vacuum pan. After this step the fat fraction is added, followed by further condensation. Similarly, French patent specification 476,719 discloses an obsolete process where a fat fraction is added to partially condensed low-fat or creamed milk. As in U.S. Pat. No. 1,432,633, use is made of a vacuum pan. This discontinuous process is used, according to the French publication, to facilitate the obtainment of an emulsion. The maximum temperature in the emulsifying process described is 54° C. In the process according to the invention, different fats and/or emulsifiers or emulsifier-containing compositions, such as phopholipid-containing compositions, buttermilk or butter serum, can be added to the same or different effects of the evaporator. The addition can take place before, in or after the liquid collector of an effect. It is a further advantage of the process according to the invention that fatty acids which, for the purpose of certain uses, should occur in the fat fraction in very low percentages (0.05-0.5%) and in exact proportions, such as GLA, AA, EPA, DHA in the food of the premature child, are permanently present in the food in accurate amounts and proportions. Another advantage of the process according to the invention is manifest in the case where powders are prepared. Milk powder which has been prepared in accordance with the present invention is less susceptible to fat decay during operations taking place before packaging under nitrogenous and/or carbon dioxide atmospheres, such as mixing with other ingredients or bacteriological checks. The milk fluid which is the starting material of the process according to the invention and to which the `unsaturated` fat is added in one or more effects of the evaporator, may or may not be obtained through recombination of milk raw materials and optional additives. Thus, suitable milk liquids can be composed from whole milk (powder), partially creamed milk (powder), skim milk (powder), buttermilk (powder), butter serum, whey (powder), desalted whey (powder), derivatives recovered from whey--for instance lactose; hydrolyzed lactose; whey protein; whey protein fractions; galactoligosaccharides; and milk sugar-low whey powder--casein, glycomacropeptide-free casein, protein hydrolysates, and combinations of these raw materials. Optionally, it is possible to add, as additives, milk-foreign protein and/or carbohydrate sources, vitamins, minerals that are not prooxidative, nucleotides, nucleosides, aromatic, flavoring and coloring substances, amino acids and stabilizers After, optionally, a preheating step and/or a homogenization step has been carried out, the milk liquid, after being prepared, is fed to the evaporator. During the evaporation process the fat fraction is added in one or more effects of the evaporator. Next, known process steps, such as homogenization, pasteurization, sterilization or spray-drying take place. If a concentrated liquid product is prepared, this is subsequently packaged in appropriate amounts in bottles, cans or other containers. In the case where the intended product is powdered, packaging takes place in containers, typically utilizing liquid nitrogen and/or carbon dioxide. The fat fraction which is fed into one or more effects of the evaporator, for instance by spraying, may contain fats such as fish oil, egg yolk fat, liver fat, evening primrose oil, algae oil, soya oil, corn oil, sunflower oil, groundnut oil, butter oil, lard, olive oil and fractions or mixtures thereof. Further, emulsifiers or emulsifier-containing liquids, such as buttermilk or butter serum which contain many phospholipids, can be sprayed in one or more effects of the evaporator. Optionally, in addition, antioxidants, for instance ascorbyl palmitate, butylhydroxytoluene (BHT), vitamin E, (α-tocopherol), β-carotene, and lecithin can be added. The present invention will now be further elucidated with reference to the drawing and in and by the following examples. BRIEF DESCRIPTION OF THE DRAWING The drawing shows an effect of a multiple-effect evaporator. DETAILED DESCRIPTION OF THE INVENTION The milk liquid to be evaporated is introduced via pipe 1 into effect 2. Upon leaving pipe 1, the milk liquid is equally distributed by divider plates 3 over the downpipes 4. The milk liquid forms a film over the walls of these downpipes 4, which are heated externally with water vapor introduced via pipe 5. A two-phase flow of concentrate and vapor enter liquid collector 6, where product and vapor are separated. The product is pumped through pipe 7 and pump 8 to the divider plate of the next effect. The vapor is directed via line 9 to the next effect to condense on the outside of the downpipes. In the process according to the invention, a fat fraction can be supplied under the downpipes 4 or to the product flow in pipe 7. EXAMPLE 1 Powdered food Product for premature children 1628 kg liquid containing 81 kg skim milk solids, 24.5 kg whey protein solids obtained through ultrafiltration, and 188 kg desalted whey solids, was divided in 2 portions A and B of 814 kg each. The solids content of this liquid was 18%. To portion A (comparative example), 83 kg liquid fat (stored under nitrogen) was added with mixing at 50° C. This fat had the composition as shown in column C of Table I. This fat-enriched liquid was subsequently evaporated to a solids content of 46% in an evaporator with three effects. Portion B (invention) was evaporated to the extent where a product flow of a solids content of 35% was fed into the last effect of the evaporator. Under the downpipes of this last effect, 83 kg of the above fat composition was added to the liquid in a constant flow at 50° C., in such a manner that the fat was evenly distributed during the evaporation time that likewise a liquid of a solids content of 46% was obtained. Both portions were subsequently homogenized in a two-stage homogenizer (100+30 bar), followed by cooling to 8° C. and the addition, with mixing, to the liquid of a number of additives which are conventional for food for premature infants: minerals, except for copper and iron, vitamins, amino acids, taurine, uridine monophosphate, guanosine monophosphate, inosine monophosphate, cytidine monophosphate, adenosine monophosphate. Then both portions were spray-dried (inlet temperature 186° C., outlet temperature 90° C.) and a conventional premix (containing iron and copper) was admixed to form the desired end product. This product was packaged in cans, under nitrogen or not. From a determination of the peroxide numbers of the fat fraction the powders of batch B possessed a higher stability than the powders of batch A over a storage period of 13 and 26 weeks, respectively. The peroxide numbers of the fat fraction were determined according to a modification of the method of Loftus Hills and Thiel (Loftus Hills, G. and Thiel C. C., J. Dairy Res. 14 (1946), 340; Australian Standard N 63, (1968), p 22). According to this method, the fat is extracted from the powder at 55° C. with a mixture of 1-chlorobutane/methanol, whereafter the peroxides present in the extract oxidize Fe(II) ions which have been added with a reagent, to form Fe(III) ions, whereafter the latter ions are determined spectrophotometrically by means of an ammonium rhodanide stain. The Table below presents the results of this peroxide number determination. ______________________________________ Peroxide number of the fat (meq/kg) in 20 samples Storage period at 20° C.: 13 weeks 26 weeks______________________________________Batch A, not packaged under N.sub.2 0.7 1.4Batch B, not packaged under N.sub.2 0.02 0.6Batch A, packaged under N.sub.2 0.3 1.4Batch B, packaged under N.sub.2 0 0.7______________________________________ A comparable conclusion could be drawn from tests where the fat fraction was enriched with additional antioxidant (dose 200 ppm ascorbyl palmitate on the fat, and 1000 ppm Ronoxan A® containing 25% ascorbyl palmitate, 5% dl-α-tocopherol and 70% lecithin), whether or not combined with bringing the powder under nitrogen gas directly after drying. The addition of fat in the last effect of the evaporator led to an improved and optimum result in terms of product stability. Comparative Example 2 Evaporated milk ("Evap") In accordance with a known method (C), 62 kg soya oil was added with vigorous stirring to a mixture of 390 kg whole milk, 1496 kg low-fat milk, and 107 kg butter serum. This mixture was heated up by known techniques, heated at 120° C. for three minutes and evaporated to 7.8% fat and 18% non-fat milk solids (nfms). This product was subsequently homogenized (150+25 bar, 50° C.). This was followed by final standardization to 7.8% fat and 18% nfms with either water, or different amounts of solutions of Na 2 HPO 4 and/or NaH 2 PO 4 supplemented with water. This was followed by packaging in cans and sterilization at 121° C. EXAMPLE 2 Evaporated milk ("Evap") In accordance with the process of the present invention (D), 390 kg whole milk (4.38% fat and 8.85% nfms) was mixed with 1496 kg skim milk (0.03% fat and 9.24% nfms) and 107 kg butter serum (0.53% fat and 8.44% nfms). This mixed milk was heated to 120° C. by known techniques, followed by sustained heating for 3 minutes. The hot milk was then transferred onto the first effect of a falling film evaporator (two effects) and evaporated to a solids content of approximately 21%. Under the downpipes of the second effect, 62 kg soya oil of 50° C., evenly distributed over the entire required evaporation time, was added in a constant flow. Thus a product with 7.8% fat and 18% nfms was obtained. This evap was subsequently homogenized in the conventional manner (150+25 bar, 50° C.) and standardized either with water or with a solution of Na 2 HPO 4 and/or NaH 2 PO 4 in water. Finally, the evap was sterilized in cans, as described with reference to the traditional method (C). EXAMPLE 3 Concentrated milk was produced as in Example 2, except that the butter serum was not mixed with the other milk liquids before evaporation but, after heating to 50° C., was injected into the second effect of the evaporator right beside the soya oil. The evap could be sterilized without addition of phosphates or other milk-foreign stabilizers. EXAMPLE 4 Concentrated milk was prepared as in Example 3, but the soya oil was replaced with an oil containing 81% oleic acid (see oil B, Table I). EXAMPLE 5 Concentrated milk was prepared as in Example 3, but the soya oil was replaced by fatty mixture C, as indicated in Table I. According to the process of the present invention such as it has been illustrated in the Examples, oxidation-sensitive fatty acids enter into contact with oxygen to a minimal extent as compared with the process according to the comparative example. As a result, remarkably stable milk concentrates having a prolonged storage life are obtained by a simpler process operation. TABLE I______________________________________Fatty acid % Soya oil Oil B Fat mixture C______________________________________C8:0 1.1C10:0 1.1C12:0 12.6C14:0 4.6C15 (a)isoC15:C16 (a)isoC16:0 10.5 3.5 20.7C16:1ω7C17 anteisoC17 isoC17:0C17:1ω9C18:0 4.0 4.0 3.1C18:1ω9 22 81 36.5C18:1ω7 0.1C18:2ω6 54.5 9.0 15.80C18:3ω6GLA 0.35C18:3ω3 7.5 1.9C18:4 0.05C20:0 0.5 0.5C20:1ω9C20:1ω7C20:2ω6C20:3ω6C20:3ω3C20:4ω6 AAC20:5ω3 EPA 0.25C22:0 0.5 1.0C22:1ω9/11C22:2ω6C22:4ω6C22:5ω3C22:6ω3 DHA 0.35C24:0C24:1ω9other 0.5 1.0 1.50______________________________________

1a

[0001] This application is a divisional application of patent application Ser. No. 09/664,074, entitled Device and Method for Therapeutic Treatment of Living Organisms, filed on Sep. 19, 2000. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to devices containing arrays of light-emitting diodes (hereinafter LED's) which are employed in photo-therapy for various living organisms. [0004] 2. Description of the Relevant Art [0005] Many U. S. and foreign patents disclose the use of light sources such as laser diodes and light emitting diodes emitting electromagnetic radiation of various wavelengths (i.e., colors) for administering positive and beneficial treatments to living organisms (including mammals) for injury, pain relief and illness. [0006] U. S. Pat. No. 5,187,377 discloses LED arrays comprising a substrate and two sets of LED's emitting different colors of light which can be used as light sources for facsimile or scanner devices. The first and second sets of LED's are connected in series so that a current alternatively flows through one set or the other, in opposite directions. The two sets of LED's connected in series are further connected with each other in parallel. [0007] U. S. Pat. No. 5,500,009 to Amron, Ltd. discusses the use of lasers and LED's in photo-therapy for the treatment of various ailments in humans. A method of treating herpes is disclosed which uses at least one LED emitting red light, preferably an array of LED's which can be directed to concentrate the light. The voltage can be varied to vary the intensity of the light, and the lights can be pulsed. [0008] U. S. Pat. No. 5,358,503 discloses a photo-thermal therapeutic device using arrays of LED's for the simultaneous or selective treatment of areas of skin and adjacent subcutaneous structure in human subjects, utilizing photo energy and therapeutic heat. The LED array is held in a flexible or preformed holder to provide contact with the skin. Heat as well as light are provided through the LED's, and the intensity of the light and heat can be varied. Resistors cause each LED to act as a heat sink during photo-therapy treatments. This patent cites U. S. Pat. Nos. 4,535,784 and 5,024,236 which disclose photo-therapy applied to human accupuncture points. [0009] U. S. Pat. No. 5,913,884 to Boston General Hospital discusses a method for modulating wound healing in a mammal, which employs arrays of LED or laser irradiation applied after the administration of the appropriate photo-sensitizer, which activates the light process. [0010] U. S. Pat. No. 5,634,711 discloses hand-held portable light emitting devices suitable for photo-curing and photo-therapy applications. LED arrays are used, with means for varying the level of light energy. [0011] U. S. Pat. No. 4,930,504 discloses devices and methods for bio-stimulation of tissue, comprising arrays of monochromatic radiation sources of multiple wavelengths. The radiation sources are arranged within the arrays so that radiation of at least two different wavelengths passes directly or indirectly through a single point within the treated tissue. Laser diodes or super-luminous diodes can be used as radiation sources. Controls are provided to turn the device on or off, vary pulse frequency and duration and time the duration of treatment. Columns 7 and 8 of the patent discuss “two-photon events” which are described as being produced by mixing of radiation of multiple wavelengths. [0012] U.S. Pat. No. 5,766,233 to Biolight Patent Holding AB discloses devices for healing wounds and sores by photo-therapy. Arrays of LED's are held close to or in contact with the affected areas. LED's emitting infrared and red light are included, and can be pulsed in predetermined sequences for therapeutic purposes. [0013] U. S. Pat. No. 5,278,432 to Quantum Devices, Inc. discloses apparatus for providing radiant energy, including LED arrays with power-regulating circuits, to enhance and test plant growth. Several sets of series-connected LED's are arranged on a substrate and the light intensity can be varied by the power-regulating circuit. [0014] U. S. Pat. No. 5,913,883 discloses a therapeutic device for supplying beneficial light to organic tissue including a carrier (in the form of a human mask) containing an array of single frequency LED's. The power supply provides a fluctuating or pulsating output voltage. [0015] U. S. Pat. No. 4,646,743 to Parris discloses therapy radiation apparatus for veterinary medicine which include arrays of infrared LED's. The LED arrays can be mounted in flexible means for wrapping about the outer surfaces of an animal, or in the form of rigid probes for irradiating internal surfaces. Devices referring to this patent are produced commercially under the BIOSCAN™ trademark. [0016] U. S. Pat. No. 5,660,461 to Quantum Devices, Inc. discloses LED arrays assembled from pluralities of modular units which are snapped together. Reflector units are provided to direct the radiation. The modules can be electrically connected together in series or parallel. The arrays can be used to stimulate plant growth or for photo-dynamic therapy. [0017] U. S. Pat. No. 5,445,608 discusses various methods of photo-dynamic therapy, and discloses methods and apparatus for providing such therapy by employing an implantable probe to illuminate internal treatment sites which have been perfused with photo-reactive agents. The apparatus can include arrays of LED's or solid-state laser diodes. [0018] Review of a selected portion of the patents discussed above documents that photo-therapy has become an accepted and established modality for the noninvasive and safe treatment of [0019] burns, cuts and abrasions, [0020] muscle, tissue and tendon repair, [0021] cancerous tumors, [0022] herpes, [0023] arthritis and other inflammations, [0024] the stimulation or sedation of acupressure meridian points in humans and animals, [0025] bone fracture repair, and [0026] stimulation of plant growth. SUMMARY OF THE INVENTION [0027] It is a primary object of the present invention to improve upon the prior art devices and expand the usefulness of the methodology of photo/light therapy. [0028] The present invention is an improvement of recent patented photo-therapy devices as well as photo-therapy devices we have been testing for approximately three years. Preferred embodiments of present day photo-therapy devices have certain limitations. Firstly, they are designed to be used “on or near the skin surface” in order to be effective. This is a drawback in many scenarios—such as in large ranching operations where it is typical for livestock (cow, bull, horse) to injure itself on the range—perhaps a few miles to hundreds of miles from the nearest clinic. An animal of 1000-3000 pounds in pain and duress needs to be considered dangerous and puts the practitioner at considerable risk. The present invention allows for the therapeutic treatment to take place at a distance of approximately ½ foot to several feet away, thus assuring the safety of the practitioner while bringing pain relief and healing to the animal being treated. [0029] Also in the case of severe burns where infection is an acute problem and rapid skin rejuvenation can make the difference between life and death, the present invention can effectively be used at a more comfortable distance from the patient's skin surface without excessive pain from close contact of “on or near the skin surface” of other prior art photo-therapy devices. There is documentation that treatment with photo-therapy increases the healing process to take place much faster than without photo-therapy being applied, and therefore raises skin resistance to infection and other septic/toxic poisoning. (Hospitals refer to slow healing as “dysfunctional healing” because it allows for depressed immune systems, surgical complications, joint contracture, scar tissue growth, and even depression to set in before significant healing can begin). [0030] Another advantage of having the capability or option of working from a distance is that the LED's (unlike lasers) diffuse as the unit gets further and further away from the object being illuminated. Thus a larger area—double, triple or more—can effectively be covered. This allows for a manufacturing savings because an LED unit having a 6 inch radius, when positioned on or near a surface, can only illuminate about 6-8 inches. However, the same 6 inch radius LED unit, working from a distance of several feet, can illuminate an area of 12 inches, 24 inches, 40 inches, etc., depending on the amount of power (energy level in watts), high intensity of the LED's, and the time treatment duration. (Increased duration or time of treatment needs to be adjusted, the further from the surface). [0031] Another advantage of the present invention is the ability of the user to program or compose his/her own settings—which may effectively need to vary from one individual to another, instead of being limited to the pre-determined settings of other prior art devices. A separate computer might be connected to the light-emitting device for this purpose. [0032] Yet another advantage is the “flicker fusion phenomenon”, a theta wave setting at about 3-5 hertz which causes brain neurotransmitters (chemicals and electromagnetic charges) to be produced and fired off to give a relaxation effect, a drop in heart rate, drooping eyelids, etc. Many tests which were carried out in the 1950's, especially in mental institutes, indicated that the “relaxation effect” was an important ingredient in the overall health and mental stability of the patient. More recent tests conclude that relaxation (also accomplished through guided visualizations, music of nature sounds such as running water and birds chirping, hypnosis and meditation techniques) enhance traditional healing modalities (drug therapy and surgery) especially in cases of heart attack and terminal illnesses and such relaxation practices are presently being offered in some major hospitals such as Columbia Presbyterian in New York City. [0033] Another advantage of this invention is that one program setting is the “Wave Effect Frequency”—alternating colors rippling in succession from head to foot, again and again. (i.e., IR, then red, then orange, then green, then blue in slow succession, rapid succession or slow to rapid succession). This unit might be embodied in something resembling a tanning bed. [0034] Another improvement is the pre-set program to control a decrease or increase in power outage. Some requirements might call for “soft” energy (low wattage amount delivered over a longer time duration) while others call for a “bursting” effect (high wattage delivery for short durations). [0035] Yet another advantage is that the use of high intensity IR diodes inexpensively adds a hypothermia effect without the additional cost of heat sinks, resistors, etc. (which add expense to the manufacturing process). [0036] The present invention's ability to choose only one wave frequency (color) at a time gives an added advantage. It is well accepted in therapeutic injury repair that the first 24-48 hours after an injury ice or cold compresses should be used, then heat or warmth such as an IR heat lamp, heating pad, or muscular creams such as Ben-gay or tiger balm. [0037] The present invention can allow one device for both cold and heat treatments, with the added advantage of the red-wave frequency for immediate pain relief and/or bleeding reduction, decrease in inflammation and increase in energy flow, and a predisposition to inhibit infection. In this scenario, first the red-wave frequency would be used until desired results were obtained. Thereafter, the blue wave frequency (cools, soothes, reduces irritability of skin surface) would be applied. Lastly, the IR wave frequency, which causes a thermal effect, would be applied. [0038] In case of illness or emotional trauma or stress these three wave frequencies would be more effective if used simultaneously rather than consecutively as explained above. [0039] The present invention does not preclude the addition of other modalities or art forms to be used in combination with this preferred embodiment, as research data becomes available for increased effectiveness of adding such forms. These include, but are not limited to, magnets and magnetic therapy; audio sounds, ultra-sound and audio waves; electroplated holograms/holoforms; electromagnetic devices; and words or symbols having a significant intent. [0040] Another advantage over prior art devices is in the methodology of “Whole Body Treatment”. The construction of larger units than now available and/or the capability of working at a distance away from the skin surface allows for the timely and advantageous treatment of the entire body structure rather than the limited treatment of a localized area or spot. Thus, three body systems are being covered in one usage, saving time and money. These three systems are the physical/skeletal, the acupuncture meridian, and the bio-electromagnetic energy field. (This later system has thus far been less traditionally researched by the Western World, but the encyclopedia-size book by Dr. Richard Gerber, M.D. Vibrational Medicine (Bear and Co., Santa Fe, N.M. 1988), substantiates and clinically documents the existence and importance of this “E-Field”). [0041] Other objects and advantages of this invention will become apparent from perusal of the following detailed description, drawings and the appended claims, the drawings forming a part of the specification wherein like reference numerals designate corresponding parts in the several views. BRIEF DESCRIPTION OF THE DRAWINGS [0042] [0042]FIG. 1 is a perspective view of a light panel for a photo-therapy device in accordance with a first embodiment of the invention. [0043] [0043]FIG. 1A shows schematically the arrangement and color output of the light sources for the light panel of FIG. 1. [0044] [0044]FIG. 2 is a perspective view of a control panel for the light panel of FIG. 1. [0045] [0045]FIG. 3 is a perspective view of a hand-held model of a photo-therapy device in accordance with a second embodiment of the invention. [0046] [0046]FIG. 3A shows schematically the arrangement and color output of the light sources for the light panel of FIG. 3. [0047] [0047]FIG. 4 is a perspective view of a large, wall-mounted photo-therapy device according to a third embodiment of the invention. [0048] [0048]FIG. 5 is a perspective view of a photo-therapy device according to a fourth embodiment of the invention wherein the device is configured as a receptacle resembling a tanning bed with the lid open. [0049] [0049]FIG. 5A is a perspective view of the photo-therapy device of FIG. 5 with a patient in the receptacle and the lid partially closed. [0050] [0050]FIG. 6 shows the hand-held model of FIG. 3 in operation in close proximity to a patient being treated. [0051] [0051]FIG. 6A shows the hand-held model of FIG. 3 in operation at a remote distance from a patient being treated. [0052] [0052]FIG. 7 is a schematic of the circuit for operating the photo-therapy devices of this invention. [0053] [0053]FIG. 7A is a circuit diagram of the SWITCH NETWORK and CONSTANT CURRENT SOURCE of the operating circuit shown in FIG. 7. [0054] Before explaining the disclosed embodiments of the present invention in detail, it is to be understood that the invention is not limited in its application to the details for the particular arrangements shown, since the invention is capable of other embodiments. Also, terminology used herein is for the purpose of description, not of limitation. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0055] All of the preferred embodiments explained below can be used for animals, humans, plants or for any living organism [0056] Referring now to FIG. 1, there is shown one embodiment of the present invention which is of general use for living organisms. The LED unit 1 has a generally box shaped housing 2 with a plurality of LED's 3 arranged in an array of rows and columns. There is an electrical connection 4 near the bottom of the housing 2 leading to a control box 5 which will be explained later. The approximate dimensions of LED unit 1 are 7.4×4.7×1.3 inches (these dimensions are not critical and may vary). The physical spatial arrangement of the LED's are shown in FIG. 1 A where the red emitting LED's are designated by R in the circles, the IR emitting LED's are designated by I in the circles and the blue emitting LED's are designated by B in the circles. There are 48 LED's in all, 24 LED's emitting red light at 630 nm, 12 LED's emitting infrared (IR) light at 880 nm, and 12 LED's emitting blue light at 470 nm. The LED array has 6 columns of LED's and 8 rows of LED's. In the first column of the LED array, starting with a red emitting LED, the red emitting LED appears at every other one with a blue emitting LED inbetween; thus, there are four red emitting LED's and four blue emitting LED's. In the second column of the LED array, starting with an IR LED, there appears an IR LED at every other one with a red emitting LED inbetween; thus, there are four IR LED's and four red emitting LED's. In the third column of the LED array, starting with a red emitting LED, there appears a red emitting LED at every other one with an IR LED inbetween; thus, there are four red emitting LED's and four IR LED's. In the fourth column of the LED array, starting with a blue emitting LED, there appears a blue emitting LED at every other one with a red emitting LED inbetween; thus, there are four blue emitting LED's and four red emitting LED's. The fifth column arrangement of LED's is similar to the first column arrangement of LED's and the sixth or last column arrangement of LED's is similar to the second column arrangement of LED's. The number of LED's in the array and, consequently, the size of the housing 2 may vary depending on the particular application. The red, blue and IR light emitting LED's, as well as their availability, are well known in the art and, therefore, are not explained further. [0057] Referring now to FIG. 2, there is shown a control box 5 which is electrically connected to LED unit 1 (shown in FIG. 1) via an electrical connection 6 . The control box 4 contains circuitry therein and has several control knobs for controlling various aspects of the LED array. The circuitry and functions of the control knobs will be explained later. [0058] [0058]FIG. 3 shows a portable, hand held model 7 of the present invention. The hand held model 7 has a frusto-conical shaped housing 8 with a disk shaped support 9 for a plurality of LED's 10 arranged in a patterned array. Attached to the housing 8 is a handle 11 and a control knob 12 . The handle 11 has an on/off switch 13 and an electrical connection 14 which is connected to a control box 15 . This hand held model 7 is also provided with an electrical ac plug-in connector 16 for the control box 15 . The LED support 9 contains 184 LED's arranged in a particular pattern. The patterned array contains 119 red emitting LED's, 40 IR emitting LED's and 25 blue emitting LED's. The particular physical spatial arrangement of LED's is shown in FIG. 3A where the red emitting LED's are designated by R in the circles, the blue emitting LED's are designated by B in the circles and the IR emitting LED's are designated by 1 in the circles. The support disk 9 has a diameter of approximately 8 inches and the length of the handle 11 is approximately 5 and ⅞ inches (these dimensions are not critical and may vary). [0059] [0059]FIG. 4 shows yet a further embodiment of the present invention. A photo-therapy device 17 takes the form of a wall panel 18 . The wall panel 18 has dimensions of 3 feet by 6 feet by 3 inches; however, the size of the wall panel 18 may vary depending on the size of the subject or object being treated. The wall panel 18 has 24 LED's 19 in each column along its smaller dimension of 3 feet and 48 LED's in each row along its larger dimension of 6 feet. There are a total of 1,152 LED's in the wall panel 18 ; 230 LED's emitting red light at 630 nm, 230 LED's emitting IR light at 880 nm, 231 LED's emitting blue light at 470 nm, 231 LED's emitting green light at 565 nm and 230 LED's emitting amber light at 590 nm. Each LED emitting in a particular color (wavelength) would alternate in a repeated pattern, for example, blue, green, amber, red, IR (repeat, etc.). The LED's 19 in the wall panel 18 are connected to the control box 20 with its control knobs. The wall panel 18 if attached to a wall at an appropriate height and a person, animal or plant would be positioned in front of it for treatment. The subject of the photo-therapy treatment is positioned in front of the wall panel 18 for an appropriate amount of time at a distance from close proximity to several feet. For example, a wall panel 18 is hung on each side of a horse trailer (inside) and a horse placed between the wall panels 18 for treatment. Another example, a bull rider or horseback rider who is in need of treatment stands between the wall panels 18 in the horse trailer or in a similar enclosure at a competitive event and is treated for relaxation, pain relief or healing. Plants could also be placed in a room with a wall panel 18 on each side of the room and be treated by the light generating from the LED's of the wall panels in order to obtain faster and stronger plant growth. [0060] Referring now to FIG. 5, there is shown another embodiment of a photo-therapy device of the present invention which is used primarily for humans. The photo-therapy device takes the form of a full body bed 22 with a hollow enclosure 23 and a lid 24 and LED's embedded within the hollow enclosure 23 and lid 24 . The full body bed 22 has the following dimensions: 3 feet wide, 6 ½ feet long and a 20 inch depth; obviously, these dimensions could vary. A control box (not shown) is built into the front side of the hollow enclosure 23 and control knobs 26 are connected to the control box. An electrical cord 27 will connect the control box to an electrical outlet or generator. There are a total of 2,304 LED's inside the full body bed 22 with 1,152 LED's on the inside of the lid 24 and 1,152 LED's on the inside floor of the hollow enclosure 23 . On the inside of the lid 24 , there are 230 LED's emitting red light at 630 nm, 230 LED's emitting IR light at 880 nm, 231 LED's emitting blue light at 479 nm, 565 LED's emitting green light at 565 nm and 230 LED's emitting amber light at 590 nm. The numbers of specific LED's emitting in a particular wavelength on the inside of the hollow enclosure 23 are the same as those on the inside of the lid 24 . Each LED for a given wavelength alternates in a repeated pattern, for example, blue, green, amber, red and IR. A person for treatment would lie down in the full body bed 22 , face up, with the lid 24 partially closed; the photo-therapy treatment would provide a relaxation effect, pain reduction or healing of the person. This embodiment of the invention could also be used in a hospital or nursing home for the treatment of bedsores or it can be combined with piped-in music and thus produce a “wave effect” for deep relaxation or pain relief after an operation. It could also be used to stimulate the immune system of a human with a disease such as cancer, etc. FIG. 5 shows the full body bed 22 with the lid 24 in the fully open position whereas FIG. 5A shows a patient 28 lying within the full body bed 22 for treatment with the lid 24 being partially closed. [0061] [0061]FIG. 6 shows an application of the hand held model 7 of the present photo-therapy device being applied in close proximity to a small body area of a patient P being treated whereas FIG. 6B shows the photo-therapy device being applied to a larger body area of a patient P being treated, the latter application demonstrating a diffusion effect of the device. [0062] [0062]FIGS. 7 and 7 A are circuit diagrams showing how the LED's of the various embodiments of this invention are connected to a control box with control knobs for controlling or regulating the operation of the LED arrays in the various embodiments. The circuit diagrams show the general scheme of a photo-therapy device of this invention that is designed to provide a luminous pattern for a specific therapeutic application. The geometric pattern and color(s) of the LED array, the frequency and duty cycle of the LED array and the total time of operation of the photo-therapy device can be varied to satisfy the requirements of an intended therapeutic application. [0063] For example, FIG. 7 shows a circuit diagram for a photo-therapy device of the present invention which operates three different light source types (LED 1 , LED 2 and LED 3 ) each of which is energized independently by a processor 29 (or microprocessor) via a switch network 30 . The series strings of a particular light source type (LED 1 , LED 2 and LED 3 ) are divided into two groups, A and B, as shown in the circuit diagram. Each group A and B of series light strings will normally be switched on and off in an alternate fashion to minimize the maximum power requirements of the system. Each series of light strings A and B is energized by a constant current source 31 that insures proper operation of the photo-therapy device under varying conditions of temperature and supply voltage. In some therapeutic applications, the value of the constant current can be modified under the control of the processor 29 to conform to a custom pattern. The processor operation is controlled by the operator of the photo-therapy device by the setting of the control switch positions for TIME, FREQUENCY, PATTERN and CUSTOM. The TIME control switch will set the desired period of operation, the FREQUENCY control switch will set the alternating on/off rate between the A and B groups of light strings, the PATTERN control switch will directly select which light source type(s) (LED 1 , LED 2 or LED 3 ) to be energized or will select the CUSTOM mode of operation, and the CUSTOM control switch will select which pattern from the pattern memory module 32 that the processor 29 is to perform In this mode, the processor 29 can vary the time, frequency, power level and light source strings in any prearranged (programmed) sequence. For example, the processor 29 can be preprogrammed to provide the following patterns of illumination: a) each color set on individually, b) all color sets on simultaneously, c) at least two color sets on simultaneously and d) at least two color sets on for preset periods of time. The processor 29 may also be programmed to sequentially pulse the LED sets of the photo-therapy device to emit light of different colors. The control circuit may also be adjusted for pulsed operation of at least two sets of LED's with pulse durations of in the range of from about 0.001 sec. to about 0.2 sec. and pulse repetition rates in the range of from about 4 Hz to about 10,000 Hz. The pulse duration may be approximately half the period of each cycle. The processor 29 can also provide indications of low battery level and an elapsed time of operation in the form of a lamp and, if enabled, an audible beep. For an indication of the elapsed time of operation, the treatment timer may be connected to a visual or audio means for indicating the remaining treatment time. Although the means for indicating low battery level and elapsed time of operation are not shown, the addition of such means to the circuitry and equipment of the present invention would be obvious to one skilled in the art and is, therefore, not detailed here. [0064] The operation of each of the photo-therapy devices disclosed herein is started by depressing the START/STOP push button 33 shown schematically in FIG. 7 and a second depression of the pushbutton 33 will stop the operation independently of the time setting. [0065] Typical applications of the photo-therapy devices described above do not preclude the use of keyboards for operator input, alternate displays for status information or the use of an external computer for control of the operation of the devices. [0066] The block diagram of FIG. 7 shows the use of Light Emitting Diodes (LED's) which operate over the application-specific spectrum. However, the general scheme is not limited to LED's but other light sources may be used such as incandescent lamps. The light sources are shown in a series connection to improve electrical efficiency. Light sources of the same or different colors may be grouped as required for a particular application,. Light sources for the photo-therapy devices of this invention may include both the visible and invisible portions of the frequency spectrum. Although FIG. 7 shows that all the light sources in a given group are enabled at the same time, individual control of series strings is not precluded. [0067] The block diagram shown in FIG. 7A shows the light sources being driven by constant current sources on the low voltage side of the power supply. However, control from the high voltage side of the power supply is not precluded. A typical constant current source operating on the low voltage side of the power supply is shown in the block diagram of FIG. 7A and consists of an operational amplifier U 1 , an FET transistor Q 1 and a resistor R 1 . U 1 will cause Q 1 to conduct enough current Ir to satisfy the relationship Vs=Vr=Ir×R 1 or Iled=Ir=Vs/R 1 . Thus, the current through the LED's, i.e., Iled, is a function of Vs and R 1 and independent of the varying characteristics of the LED's as a function of temperature, power levels and individual parts. The value of Vs is determined by the switch position (SW 1 A, SW 1 B, etc.) and is either the output of the digital-to-analog converter D/A or 0 volts. Since both the switch and the converter D/A are under control of the processor 29 , the individual light source strings can be turned on and off at various power levels as required by the program. [0068] The power supply for the block diagram circuit of FIG. 7 is normally a direct current (DC) voltage source converted from the normal house supply or a battery. Alternative well known power sources can also be used. The power to drive the photo-therapy devices of this invention ranges from 10 W/cm2 to 30 W/cm2. [0069] Modifications of this invention will be readily apparent to those skilled in the art and it is intended that the invention be not limited by the embodiments disclosed herein but that the scope of the invention be defined by the appended claims.

1a

FIELD OF THE INVENTION [0001] The present invention relates generally to therapeutic agents useful particularly in cancer targeted therapy but also in treating malignant adenocarcinomas, such as breast, colon, hepatic, ovarian and renal adenocarcinomas, and treating benign tumors of the uterus, hyperplasia, endometriosis, BPH, polycystic disease of the breast and pituitary adenomas. [0002] More specifically, the said invention relates to Pseudomonas exotoxin based chimeric toxins aimed at those neoplastic cells bearing gonadotropin-releasing hormone binding sites. The present invention further relates to pharmaceutical compositions comprising as an active ingredient the above-mentioned neoplastic cell-targeting chimeric toxins. Furthermore, the present invention relates to a method for the production of said chimeric toxins. These chimeric proteins, according to the present invention, are comprised of cell-targeting moieties which consist of gonadotropin releasing hormone homologues linked to cell-killing moieties which consist, preferably, of the bacterial toxin Pseudomonas exotoxin A, for recognizing and destroying neoplastic cells bearing gonadotropin releasing hormone binding sites. [0003] Targeting is a term for the selective delivery of chemotherapeutic agents to specific cell populations. It is possible to create chimeric molecules that possess cell-targeting and cellular toxin domains. These chimeric molecules function as cell selective poisons by virtue of their ability to target selective cells and then kill those cells via their toxin component. Pseudomonas exotoxin A (hereinafter called PE), a bacterial toxin used in construction of such chimeric proteins, acts by irreversibly arresting protein synthesis in eukaryotic cells, resulting in cell death. [0004] The term “gonadotropin releasing hormone homologues” in this invention relates to the gonadotropin releasing hormone gene itself or its analogues and antagonists. Also included in the scope of the present invention are salts of the described chimeric proteins. The term “salts” includes both salts of carboxy groups as well as acid addition salts of amino groups of the protein molecule. The invention further relates to pharmaceutical compositions comprising the chimeric proteins as defined above together with a pharmaceutically acceptable inert carrier. The proteins of the present invention may be administered by methods known in the art for the administration of proteins. BACKGROUND OF THE INVENTION [0005] Gonadotropin releasing hormone (hereinafter called GnRH) participates in the hypothalamic—pituitary gonadal control of human reproduction. The involvement of GnRH has been demonstrated in several carcinomas and GnRH analogue treatment has been applied in breast, prostatic, pancreatic, endometrial and ovarian cancers (Kadar et al. Prostate 12:229-307, 1988). These analogues suppress tumor cell growth in vitro and in vivo. The existence of GnRH binding sites was revealed in the corresponding malignant cells and in well-established cell lines (Emons et al. J. Clin. Endocrinol. Metab. 77:1458-1464, 1993), though preliminary results suggest that the GnRH receptor involved may differ from the previously documented receptor (Kakar et al. Biochem. Biophys. Res. Comm. 189:289-295, 1992). [0006] Although GnRH binding sites have been demonstrated in a number of solid tumors and various carcinoma cell lines derived mainly from hormone dependent tissues, their existence in colon or renal carcinoma has not been previously documented. The presence of specific GnRH binding sites in colon, breast, prostate, ovarian endometrium, renal and liver carcinomas, is shown here. Surprisingly, the specific GnRH binding sites are not limited to hormone-dependant tissues, as indicated by the marked killing of colon adenocarcinoma, renal cell adenocarcinoma and hepatocarcinoma cells. [0007] WO93/15751 describes various conjugates of GnRH, a linking group and Pseudomonas exotoxin A, prepared using the techniques of synthetic organic chemistry, used for the sterilization of animals by killing gonadotropin releasing cells of the animals pituitary gland. [0008] The present invention describes the construction, by the techniques of genetic engineering, of PE based chimeric toxins, aimed at targeting those neoplastic cells bearing GnRH binding sites. The chimeric toxins of the present invention are fusion proteins and, as such, do not contain a chemical linking group (as in the above-mentioned patent). Therefore, they are completely different proteins from the molecules described in WO93/15751. [0009] Using different kinds of targeting moieties, a large number of immunotoxins have been generated in the last 20 years by chemical linkage techniques or recombinant DNA technology. The size of these targeting moieties varies widely, ranging from large antibodies to small growth factors, cytokines and antibody fragments. [0010] The ability of large chimeric proteins, as the Met-GnRH-PE constructions described in the present invention, to target cells via a very small portion of the polypeptide (a peptide of ten amino acids, as used as the targeting moiety of the present invention), and yet retain their original functions, namely binding and internalization, open up new possibilities in designing targeted immunotoxins. [0011] Colon, breast, and prostate cancer—three out of the four major malignancies occurring in humans, together with ovarian, endometrium, renal and liver carcinomas, account for more than 50% of cancer related death. The presence of specific GnRH binding sites in all of these cancers, may suggest a more general role of GnRH and/or GnRH-like peptides in the malignant process. [0012] Collectively, these results disclose what could be considered the Achilles' heel of these malignant growths, a finding that could open up new vistas in the fight against cancer. [0013] In view of their efficient growth inhibition of the above-mentioned cancer cells and their specificity regarding the non-target cells, the novel Met-GnRH-PE chimeric toxins are promising candidates for cancer treatment. SUMMARY OF THE INVENTION [0014] The present invention relates particularly to neoplastic cell-targeting chimeric toxins comprising cell-targeting moieties and cell-killing moieties for recognizing and for destroying the neoplastic cells, wherein the cell-targeting moieties consist of gonadotropin releasing hormone homologues and the cell-killing moieties consist of Pseudomonas exotoxin A. The present invention further relates to pharmaceutical compositions containing as an active ingredient these neoplastic cell-targeting chimeric toxins and to a method for the production of these chimeric toxins. The said invention also relates to a method for cancer therapy, treating malignant adenocarcinoma and hepatocarcinoma cells and benign hyperplasia including uterine leiomyoma cells, extrauterine endometrial island cells, benign hyperplasia of prostate and breast, and pituitary tumor adenoma cells, by the use of the above-mentioned chimeric toxins. DETAILED DESCRIPTION OF THE INVENTION [0015] The present invention describes Pseudomonas exotoxin A (PE) based chimeric toxins constructed by ligating an oligonucleotide encoding ten amino acids of a gonadotropin releasing hormone (GnRH) analog (GnRH coding sequence with tryptophan replacing glycine as the sixth amino acid), and a preceding Met (see FIG. 1C ), upstream of a mutated form of PE (domains I (mutated), II and III) thereby generating Met-GnRH-PE66, and a ten amino acid synthetic GnRH oligomer (GnRH coding sequence with tryptophan replacing glycine as the sixth amino acid), with a preceding Met, ligated to domains II and III of the PE, thereby generating Met-GnRH-PE40 protein. [0016] The applications, potential markets and commercial advantages of the said chimeric proteins according to the present invention are listed: [0017] There are two main applications: [0018] 1) Malignant Adenocarcinomas and Hepatocarcinomas: [0019] Breast, colon, ovarian and renal adenocarcinomas and hepatocarcinoma were all sensitive to Met-GnRH-PE mediated cytotoxicity. Thus, the potential market for this new chimeric protein includes all adenocarcinoma and hepatocarcinoma patients, either as a first line of treatment or for patients in which other modalities of treatment had failed. [0020] 2) Benign Tumors of the Uterus and Hyperplasia: [0021] This group of pathologies includes various tissues that are known to be sensitive to GnRH and thus can be targeted by the Met-GnRH-PE chimeric proteins. a. Uterine: [0023] Uterine leiomyoma is the most common benign tumor in women. The uterine myomas are found to carry a large number of GnRH receptors. GnRH analogs are clinically used for down-regulation and shrinkage of these myomas. The disadvantage of GnRH analogs is that these compounds cannot be used for long periods and the myomas return to their original size after cessation of the treatment. The use of Met-GnRH-PE for the destruction of the myomas can help to avoid what was considered to be imminent hysterectomies. b. Endometriosis—Endometrioma: [0025] The existence of endometrial tissue out of the uterus leads to the disease called endometriosis which can cause infertility, abdominal pain and even surgical interventions. The endometrial islands are known to be very sensitive to hormonal changes. One of the therapeutic modalities found to be clinically efficient is the GnRH analog. Using Met-GnRH-PE, these explants of endometrial tissue can be eliminated, thereby helping infertile couples as well as women who are undergoing laparotomy for the resection of these endometrial islands. The treatment of both the leiomyoma and the endometria can be administered systematically or locally by either ultrasonic or laparoscopic guided injection into the peritoneal cavity. c. Benign Prostatic Hyperplasia (BPH): [0027] The prostatic cells are known to express GnRH receptors and prostatic cancer is successfully treated today with GnRH agonists. The BPH causes severe symptoms of dysuria, urinary retention and sometimes can be treated only by prostatectomy. The use of Met-GnRH-PE can therefore replace prostatectomy procedures carried out on prostate hyperplasia that is not malignant. d. Polycystic Disease of the Breast: [0029] The mammary cells are also known to express the GnRH receptors. As in the case of BPH, the polycystic disease of the breast may be symptomatic, cause pain and may mimic breast carcinoma. The use of Met-GnRH-PE may eliminate the need for numerous check-ups and needless mammograms and help woman suffering from breast pains and non-malignant breast tumors. e. Pituitary Adenoma: [0031] Some of the pituitary adenomas are derived from gonadotropic cells. The pituitary adenoma, even though non-malignant, can cause a grave prognosis by causing local pressure on vital organs (eyes, brain stem). The trans-sphenoidal surgery used for the pituitary adenoma has many disadvantages, including recurrency and neurological sequela. Met-GnRH-PE may be aimed directly against the gonadotropic cells without damaging other functions of the pituitary gland. Met-GnRH-PE chimeric toxin may be administered intrathecally. [0032] Commercial Advantages: [0033] 1. The wide variety of tumors that respond to the Met-GnRH-PE chimeric protein. [0034] 2. The high selectivity that allows a large therapeutic range. [0035] 3. The use of GnRH as a targeting peptide leaving the large population of postmenopausal women in whom the GnRH has no physiological role perfect candidates for the treatment. [0036] 4. Its high specificity enables systemic administration together with the local effect. [0037] 5. The ability to eradicate small populations of cells in a tissue that will not itself be harmed. [0038] The proteins of the present invention may be administered by methods known in the art for the administration of proteins. Also included in the scope of the present invention are salts of the described chimeric proteins. The term “salts” includes both salts of carboxy groups as well as acid addition salts of amino groups of the protein molecule. Salts of the carboxy group may be formed by methods known in the art and include both inorganic salts as well as salts with organic bases. The invention further relates to pharmaceutical compositions comprising the chimeric proteins as defined above together with a pharmaceutically acceptable inert carrier. The pharmaceutical composition may be administered by injection (intravenous, intra-articular, subcutaneous, intramuscular, intrathecal or intraperitoneal) topical application, oral administration, sustained release, or by any other route including the enteral route. [0039] The said invention will be further described in detail by the following experiments and figures. These experiments and figures do not intend to limit the scope of the invention but to demonstrate and clarify it only. DESCRIPTION OF THE FIGURES [0040] FIGS. 1A-1C : Construction and expression of the Met-GnRH-PE66 chimeric toxin. FIG. 1A , SDS-PAGE gel and FIG. 1B , immunoblotting analysis of TGnRH-PE66 plasmid expression. Whole cell extract of the lysed bacteria (lane 1). Soluble fraction (lane 2). Insoluble fraction (lane 3). FIG. 1C , construction of TGnRH-PE66 plasmid. T7 promotor. GnRH analogue peptide. Ampicillin®. PE664Glu. The numbers represent the corresponding amino acids. [0041] FIGS. 2A and 2B : The effect of increasing concentrations of Met-GnRH-PE66 on various cell lines. [0042] FIG. 2A : ▪ SW-48 colon adenocarcinoma,  HepG2 hepatocarcinoma, ▴ Caco2 colon adenocarcinoma. [0043] FIG. 2B : OVCAR3 ovarian adenocarcinoma, HeLa cervix adenocarcinoma, ◯ MDA MB-231 breast adenocarcinoma, HT-29 colon adenocarcinoma. [0044] FIGS. 3A-3F : The effect of Met-GnRH-PE66 on various primary cultures. FIG. 3A , colon carcinoma primary cultures established from three patients. FIG. 3B , renal cell carcinoma primary culture. FIG. 3C , breast carcinoma primary cultures established from four patients. FIG. 3D , ovarian carcinoma primary cultures established from two patients. FIG. 3E , metastases of primary cultures established from the corresponding patients represented in FIGS. 3A , 3 C and 3 D by the same symbols. FIG. 3F , control cells: # leukocytes. bone marrow.  fibroblasts. ∇ colon. [0045] FIGS. 4A-4B : Histopathological diagnosis of primary cultures. FIG. 4A , anti-keratin positive staining of a colon primary culture. FIG. 4B , anti-desmin negative staining of a colon primary culture. [0046] FIG. 5 : Displacement of [ 125 I] GnRH bound to membranes of SW-48 cells by: ◯ Met-GnRH-PE66. ▪ GnRH analogue (des-Gly 10 , [d-Ala 6 ]-LHRH). [0047] FIG. 6 : Purification of Met-GnRH-PE66. Lane 1—protein marker. Lane 2—whole cell extract. Lane 3—soluble fraction. Lane 4—insoluble fraction after refolding. Lane 5—after DEAE-Sepharose column. Lane 6—after Sepharyl S-200 HR column. [0048] FIG. 7 : Purification of Met-GnRH-PE40: Lane 1—protein marker. Lane 2—whole cell extract. Lane 3—soluble fraction. Lane 4—insoluble fraction after refolding. Lane 5—after DEAE-Sepharose column. Lane 6—after Sepharyl S-200 HR column. [0049] FIG. 8 : Effects of Met-GnRH-PE chimeric proteins on SW-48 colon adenocarcinoma cell line: [0050] ▪ Met-GnRH-PE66 insoluble fraction after refolding. [0051] ▴ A Met-GnRH-PE66 purified protein. [0052]  Met-GnRH-PE40 purified protein. EXPERIMENTS Experiment 1. Met-GnRH-PE66 Chimeric Toxin Construction [0053] A plasmid vector carrying the mutated full length PE gene (pJY3A1136-1,3) (Chaudhary et al., J. Biol. Chem. 256:16306-16310, 1990) was cut with NdeI and Hind III. The insert was a 36 base pair synthetic oligomer consisting of the GnRH coding sequence with tryptophan replacing glycine as the sixth amino acid, and was flanked by NdeI (5′ end) and HindIII (3′ end) restriction sites. The resulting TGnRH-PE66 plasmid was confirmed by restriction endonucleases digestion and DNA sequence analysis ( FIG. 1C ). Experiment 2. TGnRH-PE40 Plasmid Construction [0054] To construct the Met-GnRH-PE40 protein (Met-GnRH-domains II and III of the PE), the TGnRH-PE66 plasmid vector ( FIG. 1C ) was digested with NdeI and BamHI and ligated to a NdeI-BamHI 750 bp fragment from the plasmid PHL-906 (Fishman et al., Biochemistry 33:6235-6243, 1994) along with an insert which is a 36 base pair synthetic oligomer consisting of the GnRH coding sequence with tryptophan replacing glycine as the sixth amino acid, flanked by NdeI (5′ end) and HindIII (3′ end) restriction sites. The resulting TGnRH-PE40 plasmid was confirmed by restriction endonuclease digestion and DNA sequence analysis. Experiment 3. Protein Expression [0055] The protein expression method was the same for Met-GnRH-PE40 and Met-GnRH-PE66, unless mentioned. Escherichia coli strain BL21 (DE3) carrying the plasmid TGnRH-PE66 was grown in LB medium containing ampicillin (100 μg/ml) and Escherichia coli strain BL21 (DE3) carrying the plasmid GnRH-PE40 was grown in Super-LB medium containing ampicillin (50 μg/ml). After reaching an A600 value of 1.5-1.7, the cultures were induced 90 minutes for Met-GnRH-PE66 and overnight for Met-GnRH-PE40, at 37° C. with 1 mM isopropyl-d-thiogalactoside (IPTG). Cells were collected by centrifugation and the pellet was incubated at −70° C. for several hours. [0056] The frozen pellet was thawed and suspended in lysis buffer (50 mM Tris HCl, pH 8.0, 1 mM EDTA and lysozyme 0.2 mg/ml), followed by sonication (3×30 seconds) and centrifugation at 35,000×g for 30 minutes. The supernatant (soluble fraction) was removed and the pellet (insoluble fraction) served as the source for the chimeric proteins and for their purification. [0057] Analysis of the insoluble fraction by SDS/PAGE gel electrophoresis revealed a major band (70%) with an expected molecular mass of 67 kDa, corresponding to the chimeric protein, and two major unrelated bacterial proteins of 42 and 28 kDa ( FIG. 1A ). Immunoblotting with polyclonal antibodies against PE, confirmed these data ( FIG. 1B ). Experiment 4. Effect of the Met-GnRH-PE66 Chimeric Proteins on Various Cell Lines [0058] In the experiments described below, the insoluble fraction of E. coli expressing cells was used as the source of the Met-GnRH-PE66 chimeric protein. [0059] The cytotoxic activity of Met-GnRH-PE66 was tested in various established cell lines: SW-48 colon adenocarcinoma, HepG2 hepatocarcinoma, Caco2 colon adenocarcinoma, OVCAR3 ovarian adenocarcinoma, HeLa cervix adenocarcinoma, MDA MB-231 breast adenocarcinoma, HT-29 colon adenocarcinoma. Unless specified, all cell lines were maintained in RPMI 1640 medium, cultured in 100 mm Petri dishes in a humidified atmosphere of 5% CO 2 /95% air at 37° C. HepG2 and Caco2 were maintained in Eagle's Minimal Essential Medium, and HeLa cells were maintained in Dulbecco's Modified Eagle's Medium. All media were supplemented with 10% fetal calf serum, 2 mM L-glutamine, 100 units/ml of penicillin and 100 μg/ml streptomycin. On day 0, cells (10 4 in 0.2 ml culture medium) were seeded in 96 well tissue culture microplates and 24 hours later various concentrations of the Met-GnRH-PE66 were added. After 24 hours incubation [ 3 H]leucine [5 μCi per well] was added for an additional 24 hours. At day 3, the plates were stored at −70° C. for several hours, followed by a quick thawing at 37° C. Cells were harvested on filters and the incorporated radioactivity was measured with a beta counter. The chimeric protein was found to kill cells in a dose-dependent manner, with considerable variation between cell lines (Table 1) ranging from the strong response of HepG2 hepatocarcinoma, SW-48 and Caco2 colon adenocarcinoma ( FIG. 2A ) to the intermediate one of OVCAR3 ovarian adenocarcinoma, MDA MB-231 breast adenocarcinoma, HT-29 colon adenocarcinoma, and HeLa cervix adenocarcinoma ( FIG. 2B ). Although cytotoxicity was measured by inhibition of amino acid incorporation, cell death was reflected in cell number and/or cell necrosis 24 hours following the addition of the chimeric protein. [0060] To confirm the specificity of Met-GnRH-PE66 activity, two other PE based recombinant proteins, expressed and extracted under the same conditions, were used as controls. No substantial growth inhibition was exerted by either PE664Glu, encoded by the mutated full length PE gene, or by PIS2, an unrelated 80 bp sequence fused to PE664Glu. When 15 μg/ml of PE664Glu or PIS2 were added, protein synthesis ranged from a slight increase to 20% inhibition in the different cultures. Growth inhibition resulting from treatment with one of the two proteins was considered nonspecific. [0061] The results are expressed as the percent of the control experiments in which cells were not exposed to any protein (results are summarized in Table 1 and in FIG. 2 ). [0000] TABLE 1 Cytotoxic Activity of Met-GnRH-PE66 on Various Cell Lines ID 50 Cell Line Origin (μg Total Protein/Well)* Caco2 Colon adenocarcinoma 0.4 HT-29 Colon adenocarcinoma 1.2 SW-48 Colon adenocarcinoma 0.3 OVCAR3 Ovarian adenocarcinoma 3 MDA MB-231 Breast adenocarcinoma 2.3 HeLa Cervix adenocarcinoma 1.8 HepG2 Hepatocarcinoma 0.3 *The ID 50 values show the effect of the insoluble fraction enriched with the chimeric protein Experiment 5. The Effect of Met-GnRH-PE66 on Various Primary Cultures [0062] In order to evaluate the cytotoxic effectiveness of the chimeric proteins on cells resembling the original in vivo tumors as closely as possible and to exclude the possibility that the Met-GnRH-PE66 cytotoxicity was a characteristic developed by cells upon prolonged passages, primary cultures were established. [0063] Fresh tissue specimens were obtained from various cancer patients undergoing therapeutic debulking procedures. Control specimens were obtained from donors or patients undergoing diagnostic or therapeutic procedures for non-malignant diseases. All tissue specimens were washed several times with Leibovitz (L15) medium, and extensively cut with a scalpel. The preparations were then enzymatically proteolysed for 2 hours at 37° C. with gentle shaking in Leibovitz medium containing collagenase type I (200 u/ml), hyaluronidase (100 u/ml), penicillin (1000 units/ml), streptomycin (1 mg/ml), amphotericin B (2.5 μg/ml) and gentamycin (80 μg/ml). Tissue preparations were centrifuged 10 minutes at 200×g and the pellets were suspended in RPMI 1640 medium, supplemented with 10% fetal calf serum, penicillin (100 u/ml) and streptomycin (100 μg/ml) and plated in 100 mm Petri dishes. Cells were grown for one to three weeks to a density of 8×10 6 cells and histopathological diagnoses and cytotoxic assays were performed. Normal leukocytes from peripheral blood and bone marrow aspirates for cytotoxic assays were obtained by diluting whole blood in one volume of phosphate-buffered saline. The diluted sample was placed over an equal volume of Ficoll-Paque and centrifuged for 10 minutes at 200×g. The cells were resuspended and plated in RPMI 1640 medium containing 20% fetal calf serum, 4 mM 1-glutamine, 50 μM β-mercaptoethanol, non-essential amino acids, 1 mM sodium pyruvate, penicillin (100 units/ml) and streptomycin (100 μg/ml). [0064] The cytotoxic effect of the chimeric protein was variable (Table 2) with up to three-fold differences in ID 50 observed in colon, breast and ovarian primary cultures originated from different patients ( FIGS. 3A , 3 C and 3 D respectively). [0000] TABLE 2 Cytotoxic Effects of Met-GnRH-PE66 on Various Primary Cultures ID 50 Origin (μg total protein/well) a Colon carcinoma 0.8-2.5 b Renal cell carcinoma 1.2 Breast carcinoma   1-3 c Ovarian carcinoma 1.6-3 d Bladder Carcinoma no effect control cells: Colon no effect e Fibroblasts no effect e Bone marrow no effect e Leukocytes no effect e a The ID 50 values show the effect of the insoluble fraction enriched with the chimeric protein b n = 3 c n = 4 d n = 2 e Increasing concentration of Met-GnRH-PE66 did not affect cell growth [0065] In cases where metastasis biopsies could also be obtained, cultures of primary tumors alongside with the metastasis were examined for Met-GnPH-PE66 cytotoxicity. The metastatic cells responded in the same manner, and their ID 50 were even lower than those of the primary tumors. This may be explained by the high homogeneity of the metastasis culture compared with that of the primary culture. [0066] Met-GnRH-PE66 was also tested on cultures of benign colon peripheral blood bone marrow and skin fibroblasts from healthy donors. The addition of up to 15 μg/ml of the chimeric protein did not result in any measurable dose dependent killing ( FIG. 3F ). Experiment 6. Histopathological Diagnosis of Primary Cultures [0067] One of the basic questions regarding the veracity of the primary culture assays is of the epithelial origin of the cells. The tendency of cells in primary culture to lose their epithelial morphology has been described in several carcinomas. To confirm the absence of any substantial amount of “contaminating” fibroblasts, differential staining was performed. [0068] Cells were stained as follows: 10,000 cells were plated on a microscope slide using a cytospin, followed by several minutes incubation at room temperature. Dried slides were fixed by soaking in −20° C. cold methanol for 15 minutes and in −20° C. cold acetone for a few seconds. Slides were kept at −20° C. until staining. Staining was carried out with anti-desmin and anti-keratin antibodies to distinguish fibroblast from epithelial cells, respectively. This staining indicated that the vast majority of the cells (80-100%) were indeed epithelial, even in cases where the cultures exhibited a fibroblast-like shape ( FIGS. 4A and 4B ). [0069] Further confirmation was achieved by staining with specific antitumor marker antigens according to the type of cancer. Formalin fixed sections from the original tumors and the primary cultures cells displayed the same pattern and intensity of staining. Experiment 7. Specific Binding by Met-GnRH-PE66 [0070] To support the findings that colon adenocarcinoma cell lines and primary cultures can be targeted and killed by Met-GnRH-PE66, the ability of plasma membrane fractions from a colon adenocarcinoma cell line to specifically bind GnRH, was examined. The addition of increasing concentrations of Met-GnRH-PE66 chimeric toxin resulted in dose-related displacement of the 125 I-GnRH bound to these membranes. A semiconfluent 100 mm dish of the SW-48 colon adenocarcinoma cell line was washed and the cells were scraped off the plate with a rubber policeman. The collected cells were homogenized in ice-cold assay buffer (10 mM Tris HCl, pH 7.6, 1 mM dithiothreitol, 0.15% bovine serum albumin, 1 mM EDTA) and centrifuged at 250×g for 15 minutes (4° C.). The resulting pellet was discarded and the supernatant was centrifuged at 20,000×g for 30 minutes (4° C.). The plasma membrane pellet was resuspended in cold assay buffer. Aliquots containing 70 μg plasma membrane protein in a final volume of 100 μl, were incubated for 2 hours on ice with 6×10 −6 M (240,000 cpm) 125 I-GnRH either in the presence or absence of (10 −4 −10 −10 M) unlabeled GnRH authentic peptide and analog (des-Gly, [d-Ala]-LHRH) or (2.5×10 −5 −10 −9 M) Met-GnRH-PE66 chimeric toxin. Following incubation, samples were washed through Whatman GF/C filters with 10 ml of cold assay buffer and counted in a gamma counter. [0071] The addition of increasing concentrations of Met-GnRH-PE66 chimeric toxin resulted in dose related displacement of the 125 I-GnRH bound to these membranes. Unlabeled authentic GnRH peptide and the analogue des-Gly10 [D-Ala6]-LHRH produced similar results. As can be seen in FIG. 5 , binding of the labeled GnRH to SW-48 colon adenocarcinoma cell line was specific and displacement by the Met-GnRH-PE66 chimeric toxin was as efficient as that by the GnRH analogue peptide. There was 37% non-specific binding. Experiment 8. Met-GnRH-PE40 and Met-GnRH-PE66 Purification [0072] The pellet of the insoluble fraction was suspended and stirred on ice in denaturation buffer (6 M guanidium HCl, 0.1 M Tris HCl, pH 8.6, 1 mM EDTA, 0.05M NaCl and 10 mM DDT). After an additional centrifugation, the reduced and denatured protein was diluted 1:100 in refolding buffer (50 mM Tris HCl, pH 8, 1 mM EDTA, 0.25M NaCl, 0.25 M L-arginine and 5 mM DTT) and kept at 4° C. for 48 hours. Refolded protein solutions were diluted to 8 mM in TE20 buffer (20 mM Tris, pH 8.0, 1 mM EDTA). DEAE Sepharose was added and stirred for half an hour at 4° C. before being packed onto a column. Washing of the column was done with 80 mM NaCl, in TE20 buffer for Met-GnRH-PE66 and 50 mM NaCl in TE20 buffer for Met-GnRH-PE40. Elution was performed with the linear gradient of 2×200 ml of 0.08-0.35 M NaCl, in TE20 (20 mM Tris, pH 8.0, 1 mM EDTA) buffer. The peak fractions were pooled, 0.5M L-arginine was added and stirred cell was used for concentration. 3 ml of the pooled fractions from the ion exchange column were loaded onto a Sepharyl S-200 HR gel filtration column, in 0.5 M NaCl, 0.15 M K-phosphate buffer, pH 6.0. The peak fractions were pooled, dialyzed against phosphate saline buffer and kept in aliquots at −20° C. Purification of Met-GnRH-PE66 and Met-GnRH-PE40 is demonstrated in FIGS. 6 and 7 , respectively. Experiment 9. Effect of Highly-Purified Met-GnRH-PE Chimeric Proteins on SW-48 Colon Adenocarcinoma Cell Line [0073] The cytotoxic activity of the purified Met-GnRH-PE66 and Met-GnRH-PE40 on the SW-48 colon adenocarcinoma cell line was assessed by measuring the inhibition of protein synthesis. The chimeric proteins were found to kill cells in a dose dependent manner. The ID 50 of the purified Met-GnRH-PE66 chimeric toxin was two to three times lower than the refolded insoluble fraction. The ID 50 of the Met-GnRH-PE40 purified protein was three to four times lower than the purified Met-( FIG. 8 ).

1a

CROSS REFERENCES TO RELATED APPLICATIONS [0001] This application is a continuation of international patent application PCT/EP2011/062462, filed on Jul. 20, 2011, designating U.S., which international patent application has been published in German language and claims priority from German patent application DE 10 2010 032 332.2, filed on Jul. 20, 2010. The entire contents of these priority applications are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] The present invention relates to a carrier for a dental impression material for insertion into an impression tray or attachment to a holding device, having a base area which replicates the human jaw and is delimited on two opposing sides by walls in order to form an approximately U-shaped cross section. [0003] Carriers of this type are generally known in the field of dentistry. There, they are used, in particular, for holding impression materials for taking an impression of the dentition of a patient. To this end, an appropriate dental impression material is filled into the carrier, into which the dentition of the patient is pressed. After the impression material has cured, a corresponding negative of the dentition of the patient is initially available. Then, by filling with plaster, this is converted into corresponding plaster models to form a positive. This positive can then be used by the dental technician to manufacture, for example, the corresponding tooth replacement or the corresponding inlays. [0004] As a result of the fact that the production of e.g. a tooth replacement takes place on the basis of a cast of an impression, the accuracy with which, for example, the tooth replacement can be manufactured is necessarily limited. In order to solve this problem, recent times have often seen the proposition of digital systems based on cameras in the field of dentistry, which digital systems should serve to capture one or more teeth or a whole jaw arch and to reproduce this in the form of digital data. By way of example, an implant can then be made on the basis of this data. [0005] Even though a certain amount of success was obtained up until now by using such techniques, it was found that these techniques also do not yet supply optimal results as a result of shadows being cast in particular, and also as a result of insufficient illumination of specific regions. [0006] In order to solve these problems, the present applicant has developed a method which is based on a combination of a measurement method on an optical basis and the use of specific impression materials. Generally speaking, impressions are taken using luminescent impression materials and then measured by means of optical methods. By way of example, this method is described in the yet to be laid-open application PCT/EP2009/006474, the entirety of which is incorporated herein by reference. [0007] In this method, in addition to using a luminescent impression material, it is furthermore indispensable for exact measurement results that the compound also has an always uniform distribution in the impression tray and is completely free of even small bubbles of air or other impurities and inclusions. Such irregularities would otherwise during the measurement method lead to inaccuracies and errors in the digital data of the dentition of the patient, which ultimately propagate right up to the manufacturing of the prosthesis and could, in individual cases, lead to a tooth replacement that cannot be used, for example. [0008] It is standard practice for the impression materials to be filled into the carriers or impression trays by the dentist or their assistant, using the conventional aids found in the laboratory. In the process, it is very difficult if not even impossible to guarantee constant uniform filling of the compound and the necessary absence of bubbles. Since small bubbles in particular can often not be identified by the naked eye either, this cannot, in general, be avoided or monitored either on the part of the treating dentist. For long-term quality control, pre-manufacturing of the impression material in a carrier of the type mentioned at the outset would be feasible. In the process, the aforementioned errors could be largely excluded or avoided by machine processes. However, this is out of the question for currently known carriers because these do not have the corresponding properties so that these can be used to perform or are able to perform the corresponding sensor-assisted measurements. [0009] The present invention is therefore based on the object of developing a carrier of the type mentioned at the outset such that it is suitable for use with the corresponding aforementioned impression materials and can be used for the above-described measurement method. SUMMARY OF THE INVENTION [0010] According to the invention, this object is achieved by virtue of the fact that at least one optical element is arranged in the base area and/or the walls, preferably that a multiplicity of optical elements are arranged in the base area and/or the walls and, in particular, that the optical elements are selected from lenses, optical fibers, filters and combinations thereof. [0011] This embodiment is advantageous in that the use of the appropriate optical elements, such as e.g. lenses, optical fibers, filters and combinations thereof, renders it possible that light information can pass through the base area and/or the walls of the carrier without significant losses. Hence such a carrier can be used with corresponding impression trays, which are equipped with light sources and/or sensors. Here, the carrier can, in principle, be considered as a highly transparent object which is suitable for the described measurement method. Other possibilities could consist of the fact that, for example, if optical fibers are used, these could be routed to a specific collection point. In the latter case, an appropriate coupling would then have to be provided on the impression tray, by means of which coupling the collected light information can be transmitted. [0012] Within the scope of the invention, a base area which replicates the jaw should be understood to mean that the part of the base area which is delimited by the walls replicates the human jaw, i.e. is roughly speaking U-shaped. Going beyond this, the base area can have any shape provided that it can be inserted into an impression tray. In addition to the pure U-shape, an embodiment in the form of half an ellipse is hereby an obvious shape for the carrier. [0013] In a further embodiment, the optical elements furthermore comprise electronic sensors, with the carrier preferably comprising at least one plug-in connection for transmitting data to a storage unit or a processing unit. [0014] As a result of using electronic sensors within the carrier, the optical information can be immediately converted into digital information by the electronic sensors in the carrier. As a result, the susceptibility to errors in the transmission of information from the impression material to the impression tray is once again reduced because this does not take place in the form of light information, but rather in the form of less susceptible digital information. To this end, the electronic sensors can then via e.g. one or more plug-in connections be connected to corresponding storage units and/or image or data processing systems (processing units). These can be arranged in the carrier itself, or else in the impression tray. Particularly for the latter variant, provision must then be made for an appropriate connection in the form of at least one connector, e.g. a plug-in connection, to the impression tray for the purpose of transmitting the data. [0015] In a further embodiment of the invention, at least one illumination means is arranged in the base area and/or the walls. [0016] For the purpose of recording the corresponding data as per the above-described measurement method, it is necessary for light to be irradiated into the impression material in advance, for example for generating fluorescence or phosphorescence. In the novel method, this until now occurs as a standard by illumination means in the impression tray. [0017] Compared to this, the aforementioned embodiment is advantageous in that the light from the illumination means no longer has to pass through the carrier and therefore cannot be additionally attenuated. There is therefore direct illumination of the impression material and, as a result thereof, of the teeth to be measured. [0018] In a further embodiment of the invention, the at least one illumination means is selected from chemiluminescent elements, LEDs, OLEDs, laser LEDs and combinations thereof. [0019] The use of these compared to incandescent illuminants of more developed illumination means has the significant advantage that, firstly, they require less space and, secondly, they develop significantly less heat. Furthermore, such illumination means can also be matched more easily to corresponding shapes, such as e.g. the shape of the carrier. Nevertheless, these generally have high luminous intensity. [0020] In a further embodiment of the invention, the carrier has a surface on the inner side thereof, which exhibits increased adherence compared to silicones. [0021] An advantage of this is that impression materials on the basis of silicone adhere better to the carrier and do not detach from the carrier, for example when the carrier is pulled away from the dentition for correction purposes—the latter could, for example, lead to the formation of bubbles and the imaging errors connected therewith. [0022] In a further embodiment of the invention, the carrier consists of an acrylate polymer, preferably polymethyl methacrylate. [0023] The use of acrylate polymers, more particularly of polymethyl methacrylate (PMMA), is advantageous in that the carrier is already better suited to the optical methods on account of the transparency of the plastic. Moreover, PMMA, for example, is non-toxic and has been established in medicine for years. [0024] In a further embodiment of the invention, the carrier is embodied as an injection-molded part. [0025] An advantage of this is that the carrier can easily be made in an injection molding method. As a result, industrial automated production of the carriers is possible. [0026] In a further embodiment of the invention, the carrier comprises fastening means for fastening to an impression tray. [0027] The embodiment with fastening means has the advantage that the carrier can be arranged on the impression tray in a secure and immovable fashion. This is necessary for the impression procedure in particular since the forces on the carrier occurring in the process could otherwise easily lead to slippage. This would inevitably once again lead to errors in the measurement procedure. Furthermore, the fastening means also render it possible to ensure that the carriers are always inserted into the impression tray in the same position. [0028] In a further embodiment of the invention, the base area and/or the side walls are at least partly mirrored on the inner side, with the at least one optical element not being mirrored. [0029] An advantage of this embodiment is that light, once it has entered the space between carrier and dentition, in which the impression material is situated, cannot simply exit through the walls of the carrier again, or is absorbed by the latter. Hence this embodiment contributes to the brightness in the gap between carrier and dentition. This in turn increases the measurement accuracy as a result of the higher light intensity. The mirroring of the at least one optical element must thereby be prevented because otherwise the use thereof for recording the optical information is hindered or rendered impossible. [0030] In a further embodiment of the invention, the carrier furthermore comprises a dental impression material, which is at least partly filled into the space defined by the walls and the base area, with the impression material preferably comprising at least one luminescent material. [0031] This embodiment is advantageous in that the carrier is thus already supplied with the ready dental impression material to the dentist or dental technician, and so they do not have to be entrusted with the filling process themselves. Hence the combination of carrier and compound can be supplied as a finished pre-produced part, with a uniform distribution of the compound and the freedom from unwanted inclusions, such as e.g. air, being ensured. [0032] In a further embodiment of the invention, the impression material is a curable impression material. [0033] The use of a curable impression material is advantageous in that this also allows the provision of a physical impression, for study purposes, to a dentist or dental technician after the compound has cured, in addition to the digital data. [0034] In an embodiment of the aforementioned measure, the impression material is at least partly cured in the region of the walls. [0035] An advantage of this embodiment is that this can prevent a patient from biting through the base plate when the impression is taken since this can have an adverse effect on the measurement. Furthermore, this measure can ensure uniform spacing of the jaw arch from the wall, which in turn improves the measurement accuracy. [0036] In a further embodiment of the invention, the carrier is designed for single use. [0037] The single use is advantageous in that the carrier, optionally with the already filled dental impression material, can be supplied to the customer, i.e. the dentist or dental technician; the latter uses, according to the invention, the corresponding carrier together with an impression tray in the measurement method and can subsequently simply dispose of the carrier which was in the interior of the mouth of the patient. This dispenses with cleaning and sterilization steps for the carriers, which steps would otherwise be necessary and which are connected to effort and costs. However, within the scope of this invention, single use can, in addition to the disposal, also be understood to mean a return to the producer or supplier. The latter would then let the carriers be cleaned and sterilized on an industrial scale and, within the scope of a recycling process, refill the carriers with impression material and deliver them to the customers. Here, appropriate marking of the carriers, e.g. by bar codes, digital data such as chips, or simple engraving, can then for example ensure that excessive re-use does not happen and that a carrier only runs through the desired number of uses. This method would be particularly expedient for those carriers that are equipped with further cost-intensive technology, such as sensors. [0038] It is understood that the aforementioned features and those yet to be explained below can be used not only in the respectively specified combination, but also in other combinations or on their own, without departing from the scope of the present invention. [0039] The invention will, in conjunction with the attached drawings, be described and explained in more detail below on the basis of selected exemplary embodiments. In detail: BRIEF DESCRIPTION OF THE DRAWINGS [0040] FIG. 1 shows a perspective illustration of an embodiment of a carrier according to the invention, [0041] FIG. 2 shows a perspective illustration of a further embodiment of a carrier according to the invention, [0042] FIG. 3 shows a perspective illustration of an impression tray which is suitable for holding a carrier according to the invention, [0043] FIG. 4 shows a perspective illustration of the impression tray from FIG. 3 with an inserted carrier in accordance with the illustration of FIG. 1 , [0044] FIG. 5 shows a perspective side view of an impression tray from FIG. 3 with two carriers according to the invention held therein, corresponding to the illustration of FIG. 1 for upper and lower jaw, [0045] FIG. 6 shows a perspective illustration of the carrier from FIG. 1 with dental impression material held therein, [0046] FIGS. 7A to 7C show perspective illustrations of carriers according to the invention in accordance with FIG. 1 , with schematically illustrated optical elements respectively being arranged in different regions: in the base area in FIG. 7A , continuously in or on both sides of the walls in FIG. 7B and in the walls on the inner side facing the dentition in FIG. 7C , [0047] FIG. 8 shows a sectionally perspective illustration of a further embodiment of a carrier according to the invention, which is arranged at one end of an impression tray and additionally has illumination means in the base area thereof, and DESCRIPTION OF PREFERRED EMBODIMENTS [0048] A carrier according to the invention illustrated in FIGS. 1 and 4 to 7 is denoted in its entirety by reference sign 10 , while a carrier illustrated in FIGS. 2 and 3 has the reference sign 12 and the carrier illustrated in FIG. 8 has the reference sign 14 . [0049] The carriers 10 and 12 illustrated in FIGS. 1 and 2 represent two main exemplary embodiments of the carriers according to the invention. Both carriers 10 and 12 have a base area 16 and 18 , respectively, which substantially replicates the shape of a human jaw. The base area 16 of the carrier 10 is laterally delimited to the outside with respect to a jaw by the wall 20 and to the inside by the wall 22 . The carrier 12 from FIG. 2 correspondingly comprises the wall 24 toward the outside and the wall 26 toward the inside. [0050] Here it is possible to see clearly the difference in the inwardly situated walls 22 and 26 between carrier 10 and carrier 12 . While the wall 26 of the carrier 12 from FIG. 2 has a parallel profile with respect to the outwardly situated wall 24 , which profile is embodied such that the teeth of the dentition to be surrounded are held as in a groove, the inwardly situated wall 22 of the carrier 10 from FIG. 1 is initially, proceeding from the base area 16 , also embodied parallel to the outwardly situated wall 20 but, in the further extent, it is oriented parallel to the palate of the patient. Hence, with respect to FIG. 1 , the inwardly situated wall 22 is upwardly closed, while the wall 26 finishes toward the top with an edge 27 . [0051] As a result of their embodiments with the base areas 16 and 18 and also the laterally delimiting walls 20 and 22 as well as 24 and 26 , respectively, both carriers 10 and 12 have a U-shaped cross-sectional profile as seen perpendicularly to the arch-shaped profile of the respective base area 16 and 18 , respectively. [0052] These carriers 10 and 12 are used to take impressions of the human jaw in patients. To this end, they are provided with an impression material 28 which is described in more detail below in conjunction with FIG. 6 and which, for reasons of clarity, is not illustrated in FIGS. 1 to 5 and 7 and 8 . Furthermore, to this end, the carrier 10 or 12 must be placed onto an impression tray 30 or inserted therein, as will be explained in more detail below on the basis of FIGS. 3 to 5 . [0053] In FIG. 3 the impression tray 30 is illustrated on its own. This impression tray 30 comprises a handle 32 and a holder 34 , which serves to hold the carrier 10 . In this exemplary embodiment of the impression tray 30 , this holder 34 comprises an area 36 which is matched to the base area 16 of the carrier 10 and onto which this base area 16 can be placed. In order moreover to ensure a secure hold of the carrier 10 on the impression tray 30 , the latter has additional fastening means on the holder 34 . In the present exemplary embodiments, these fastening means are embodied as latching openings 38 , into which corresponding latching pins (not shown in any more detail in this context) of the carrier 10 can be inserted. [0054] However, instead of these latching openings 38 illustrated here in an exemplary fashion, all other conventional connection methods known from the prior art for a connection between holder 34 and carrier 10 which permit a correspondingly fast and comfortable connection between carrier and impression tray are also feasible. Tongue and groove, screw-in and magnetic connections or similar are mentioned here in an exemplary fashion. [0055] A corresponding combination of inserted carrier 10 and impression tray 30 can be seen in FIG. 4 . [0056] However, since this arrangement in accordance with FIG. 4 merely allows an impression to be taken of only one jaw of the patient, an alternative embodiment provides for the holder 34 to be allowed to hold a further carrier 10 on its opposite side. This is illustrated in FIG. 5 . As a result, it is now possible to simultaneously make an impression of upper and lower jaw. [0057] In the preceding figures, the already-mentioned impression material 28 , and also the electronic sensors 42 and optical elements 40 according to the invention, were not illustrated for reasons of clarity. [0058] Here the impression material 28 should initially be discussed in more detail on the basis of FIG. 6 . Such an impression material 28 is preferably curable. [0059] As already explained at the outset, the present invention is based on a measurement method which is based on interplay between electronic sensors 42 , as will be described in more detail in conjunction with FIG. 7C , and a corresponding impression material 28 . [0060] In order to carry out the measurement method, the carrier 10 with the impression material 28 is inserted into a suitable impression tray, for example the impression tray 30 . Since the carrier 10 is transparent in the present case, the impression tray 30 comprises illumination elements for illuminating the impression material, and optical sensors for measuring light emerging from the impression material. In order to measure e.g. a jaw, the impression tray illuminates the compound arranged in the carrier and causes the compound to phosphoresce, for example. The user then presses the teeth or the jaw to be measured into the impression material. The impression tray is then used to measure the light emerging from the impression material. Here the measured light can originate directly from the luminescence of the compound, with it being possible for the digitized model of the jaw to be determined via the specific luminescence, i.e. the light yield per unit volume. However, it is also feasible to measure the reflections on the structures to be measured in the form of image information, with the luminescent material leading to a particularly good illumination, and to calculate the digital model on the basis of the image information. Furthermore, the method can also be based on a combination of the aforementioned measurements. [0061] Here, it is indispensable in this method for the impression material to be free from impurities or inclusions such as air, for example. Here, even the smallest air-bubble inclusions, which cannot be identified with the naked eye, are a potential cause of significant errors, which can lead to imprecision in the established data and hence also in the image of the dentition. [0062] This is extremely undesirable because this can result in subsequent errors during the production of implants or prostheses, which leads to discomfort for the patient and may, for example, lead to an implant that cannot be used. [0063] For the same reasons it is also important that the impression material 28 is introduced uniformly in the carrier 10 or 12 , i.e. that this also reduces the imprecision during the measurement to a minimum. [0064] Both can be reduced by virtue of the impression material 28 already being filled in a corresponding carrier 10 or 12 when it is supplied to the dentist or dental technician. [0065] The impression material 28 is filled into a space 43 defined by the walls 20 and 22 and the base area 16 as can be seen from FIG. 6 . It can thereby be seen from the differently shaded regions of the impression material 28 that the latter is subdivided into two regions in this preferred embodiment. These regions consist of an at least already partly cured region 44 and a non-cured or less cured region 46 . The already at least partly cured region 44 , which also extends along the base area 16 (which cannot be seen here), prevents the patient from being able to bring their teeth as far as the base area 16 or onto the inwardly situated walls 22 or outwardly situated walls 20 when the patient presses their jaw into the impression material 28 . [0066] This is necessary in particular when use is made of the corresponding impression material 28 with the preferred fluorescing or phosphorescing materials. This is due to the fact that, as already described above, the amount of light which is re-emitted by the impression material 28 after corresponding irradiation is used to determine a distance. If no impression material 28 is present between the electronic sensors 42 and the teeth of the patient (not illustrated here), for example because the tooth of the patient lies directly on the base area 16 , then it is not possible to determine a distance value in this case either. This leads to errors and, in particular, to imprecision when measuring the jaw of the patient. [0067] However, if the at least partly cured region 44 is present, the tooth finally meets this region 44 after passing through the not yet cured region 46 . The former region then prevents further penetration, for example up to the base area 16 . [0068] As already mentioned above, appropriate electronic sensors 42 are required for creating the image of the jaw. The sensors register light which originates from a reflection at the teeth or from the luminescent impression material already described above and is induced by light which is emitted by illumination means 48 . These illumination means 48 will be described in more detail below. [0069] In one embodiment, the electronic sensors 42 can already be present in impression trays 30 , which is not illustrated in any more detail in the present figures. [0070] For this case, the carriers 10 and 12 then have a multiplicity of corresponding optical elements 40 , as are described in more detail in conjunction with FIGS. 7A and 7B . In a preferred embodiment of the present invention, these optical elements 40 can for example be lenses, optical fibers, filters or combinations of these. Depending on the type and use of the utilized electronic sensors 42 , these optical elements can be arranged in such a way that, for example as shown in FIG. 7A , they are arranged in the base area 16 of a carrier 10 . Here, the optical elements are illustrated schematically in FIG. 7 as circular objects. [0071] A further option for arranging the optical elements 40 lies in merely arranging these in the walls 20 and/or 22 . Here, FIG. 7B illustrates the embodiment in which the optical elements are present both in the outwardly lying wall 20 and in the inwardly lying wall 22 . [0072] In addition to the embodiments shown in FIGS. 7A and 7B , provision is naturally also made within the present invention for those embodiments in which the optical elements 40 are arranged both in the base area 16 and in the walls 20 and/or 22 . [0073] These aforementioned exemplary embodiments of the carriers 10 with the optical elements 40 provide for the light, which is irradiated between optical elements 40 and, for example, a tooth of the patient (not illustrated in any more detail here), after the above-described reflection, or for the luminescence light emitted by the impression material to be able to pass through the optical elements 40 without significant losses to the electronic sensors 42 . [0074] Additionally, in particular in the case of using optical fibers as optical elements 40 , it is also feasible for a uniformly distributed arrangement of the optical elements 40 only to be present on an inner side 50 of the carrier 10 , and for the corresponding entrance for the light to be formed as a result thereof. Compared to this, the exit, which is formed by the other end of the optical fibers, is embodied as at least an optical fiber bundle. This optical fiber bundle (not shown in any more detail here) can then be routed to corresponding electronic sensors 42 . An illustration corresponding to this embodiment, in which merely the inner side 50 has been provided with identifiable optical elements 40 or the ends thereof, is illustrated in an exemplary fashion for the walls 20 and 22 in FIG. 7C . There it is possible to see that an outer side 52 lying opposite to the inner wall 50 does not comprise any ends of optical elements 40 . [0075] However, in contrast to the above-described exemplary embodiment, the electronic sensors 42 can also be arranged such that these electronic sensors are likewise contained in the carrier 10 or 12 and therefore form part of the optical elements 40 . [0076] A corresponding embodiment would then be designed like the one illustrated in exemplary fashion in FIG. 7C for the walls 20 and 22 . In this case, the electronic sensors 42 could either be a multiplicity of individual sensors which are distributed on the inner side 50 at the desired points of the carrier 10 . However, if use is made of optical fibers or else of lenses, an embodiment would also be feasible in which the optical elements 40 form at least one group, the optical information of which is conveyed to at least one common electronic sensor 42 . [0077] The exemplary embodiment in which the electronic sensors 42 are part of the optical elements 40 in the carrier 10 also differs from the aforementioned exemplary embodiment, in which the electronic sensors 42 are arranged at corresponding points in the impression tray 30 , by virtue of the transmission of the collected data. [0078] In the first-mentioned exemplary embodiment, the data are initially transmitted through light connectors still in the form of the corresponding light, while in the second embodiment the data are transmitted already in the form of digital data. Depending on the type of the electronic sensor 42 , this data could also already be processed at least to a certain extent. [0079] Here the second embodiment is preferred in view of the data transmission because, in addition to a simpler data-transmission connector between carrier 10 and impression tray 30 , this digital data transmission is also less susceptible to errors. [0080] The connector not shown in any more detail here for transmitting the optical or digital data can, for example, be arranged in the front 54 , visible in FIG. 3 , at the end of the area 36 on the impression tray 30 . [0081] Continuing with reference to the embodiments of FIGS. 7A to 7C , provision is additionally made in a preferred embodiment for the base area 16 and/or the walls 20 and/or 22 to be mirrored at least in part on the inner side 50 . Irradiated or emitted light is therefore reflected by the walls 20 , 22 and/or the base area 16 rather than being absorbed. Hence the resultant amount of light available for the measurements is greater, increasing the accuracy. However, what is important in this case is that unwanted mirroring of the optical elements 42 is omitted because this interferes with the measurement. [0082] FIG. 8 shows another carrier 14 according to the invention, which is similar to the carriers 10 and 12 and detachably attached to an impression tray 46 . [0083] The impression tray 56 is comparable to the impression tray 30 illustrated in FIGS. 3 to 5 , but it does not have an area 36 for holding the carrier 14 . In this exemplary embodiment of FIG. 8 , the fastening to the impression tray 56 takes place via a connection end 58 , which is comparable to the front 54 of the impression tray 30 and has additional fastening means in accordance with the explanations made above in respect of the area 36 . [0084] In contrast to all previous illustrations of the carriers 10 and 12 , the carrier 14 in FIG. 8 can be seen from underneath. Here, it is possible to see that illumination means 48 are arranged in the base area 60 . These illumination means 48 are connected via actuation lines 62 to one another and/or to a control and power supply (not shown in any more detail here). These can be arranged both in the carrier 14 and in the impression tray 56 . In the latter case, the connection between the actuation line 62 with the control in the impression tray 56 takes place via a connection point (not shown in any more detail here) in the connection end 58 , for example a plug-in connection. [0085] The illumination means 48 , which are illustrated here as circular objects, can preferably be LEDs, or else OLEDs, laser LEDs or combinations of these. A further preferred embodiment also provides for embodying the illumination means 48 as chemiluminescent elements, both on their own and in combination with the aforementioned illumination means. [0086] In addition to the embodiment shown in FIG. 8 , in which the illumination means 48 are arranged in the base area 60 of the carrier 14 , provision is likewise made within the scope of this invention for the illumination means to be arranged either in an outwardly lying wall 64 and/or an inwardly lying wall 66 , as well as both in the walls 64 and/or 66 and in the base area 60 . [0087] So that the light emitted by the illumination means 48 , in accordance with the illustration for the carriers 10 and 12 , also impinges on the teeth of the dentition of the patient arranged on the inner side 50 or on the impression material 28 , the exit openings of the illumination means 48 must be arranged on the inner side 50 . As an alternative to this, it would also be possible for the light of the illumination means 48 to pass through corresponding optical elements 40 , such as e.g. optical fibers, lenses, filters or combinations of these, which are situated on the inner side 50 . In a further alternative embodiment it would also be feasible for the material of the carrier 14 , or of the carriers 10 and 12 , to have a transparent design. [0088] Acrylate polymers, preferably polymethyl methacrylate (PMMA), should be mentioned as a preferred option for this. As a result of this, the corresponding light of the illumination means 48 could emerge through this if the latter are arranged in the carrier 14 or on the outer side 67 thereof. [0089] In addition to the appropriate material selection, provision is furthermore made within the scope of the present invention for the carriers 10 , 12 and 14 to be preferably embodied as injection-molded parts. As a result, a corresponding industrial production is made possible. [0090] Since use is often made of silicone-based impression materials 28 when the impression material 28 is used in the corresponding carriers 10 , 12 and 14 , the carriers 10 , 12 and 14 are, in a preferred embodiment, provided with a surface 68 on their inner side 50 , see FIG. 1 , which has increased adherence to silicone. This prevents the impression material 28 from inadvertently detaching from the carrier 10 or 12 . [0091] In one embodiment, the carriers 10 , 12 and 14 , shown above, can be embodied as repeatedly reusable objects. However, by contrast, they can preferably also be designed for single use. [0092] The latter preferred embodiment is advantageous in that the manufacturer can already fill carriers 10 , 12 or 14 with an impression material 28 so that the latter, as already explained above, is free from non-uniformity and unwanted inclusions. The customer, i.e. the dentist or the dental technician, can then, according to the invention, use the carriers with a corresponding impression tray 30 or 56 and simply dispose of them after obtaining the corresponding impression data. Cleaning and disinfecting, which are time-consuming and costly, are dispensed with. [0093] Building thereon, yet a further preferred embodiment also comes into consideration, in which the producer already produces a complete set of impression tray 30 or 56 , carrier 10 , 12 or 14 and impression material 28 as its own embodiment. [0094] The latter can then likewise be supplied to the dentist or dental technician, who can then likewise dispose of this after use or, in view of the electronics contained therein, return it to the producer within the scope of a recycling program. [0095] Within the scope of this invention, such a recycling program would also be feasible for the above-described carriers 10 , 12 or 14 with the impression material 28 .

1a

BACKGROUND OF THE INVENTION This invention was made with support under Grant Number 5R01 HL28539-10 from the National Institutes of Health. Accordingly, the U.S. Government has certain rights in the invention. 1. Field of the Invention The present invention relates generally to intracellular calcium overload, also known as calcium leak, which plays a role in the transition from reversible to irreversible injury during ischemia/reperfusion in cells. More particularly, the present invention relates to methods for reducing the uptake of calcium during such overload or leak conditions to reduce or prevent cell death. 2. Description of Related Art The publications and other reference materials referred to herein to describe the background of the invention and to provide additional detail regarding its practice are hereby incorporated by reference. For convenience, the reference materials are numerically referenced and grouped in the appended bibliography. It is well-known that excessive calcium influx represents the final common pathway in cell death(1). An increase in intracellular calcium has been demonstrated in response to a variety of noxious stimuli including ischemia(2), hypoxia-reoxygenation(3), metabolic inhibition(4) and reperfusion(2,5). Elevated levels of intracellular calcium are thought to be of importance in the transition from reversible to irreversible injury in cardiac(5) and other cell types(6). Although the pathogenesis of the calcium leak has been the subject of considerable research, the exact mechanism remains to be established. One proposed mechanism is the Na-Ca exchanger operating in reversed mode secondary to a rise of intracellular sodium which has been documented early in ischemia(7,8). Further support for this proposed mechanism has been provided by the demonstration that the oxygen radical scavenger 1,3-dimethyl-2-thiourea(DMTU) protects rat ventricular myocytes against hypoxia(9). DMTU was shown to be an inhibitor of Na-Ca exchange. Accordingly, it was concluded that Ca influx in hypoxia occurs via Na-Ca exchange. Other calcium leak mechanisms have been proposed in addition to the above suggested reversal of Na-Ca exchanger activity. These other mechanisms include: calcium leak through defects in the sarcolemma(SL); calcium leak via the voltage-activated calcium channels; or calcium leak through specific calcium leak channels which have been recently identified in cardiac and other cells(10,11,12). There presently is a need to provide further elucidation of the mechanisms by which calcium leak occurs and the role played by elevated calcium levels in cell death. Equally important is the need to provide methods which are capable of controlling calcium leak in order to prevent, or at least reduce, the leakage of calcium into cells during exposure to noxious stimuli. Such methods will be useful in avoiding cell damage or death. SUMMARY OF THE INVENTION In accordance with the present invention, a method is provided for reducing the uptake or influx of calcium into a mammalian cell by treating the cell surface with a cationic agent. It was discovered that alteration of the cell surface charge by treatment with a cationic agent provides an effective procedure for eliminating, or at least reducing, the amount of calcium transported into the cell during exposure to a noxious stimuli. The method may be used to treat cells either in vivo or in vitro. The method requires the exposure of the cell surface to an amount of a cationic agent which alters the cell surface charge a sufficient amount to reduce calcium uptake without disrupting the cell. The method is well-suited for treating muscle cells, such as cardiac myocytes. The method is applicable to cells having a sarcolemma or to cells in general which have calcium leak channels. As a feature of the present invention, it was discovered that the level of charge on the cationic agent is directly related to the ability of the agent to prevent calcium uptake. Accordingly, strong organic poly-cationic agents, such as protamine and polymyxin B sulfate (PXB) are especially effective in limiting calcium influx. The method of the present invention is effective in reducing calcium uptake by cells in a variety of noxious situations. These situations include metabolic inhibition and free radical attack. This versatility makes the method useful as part of a general therapeutic approach to prevent or substantially reduce cell death resulting from calcium influx. The above discussed and many other features and attendant advantages of the present invention will become better understood by reference to the following detailed description when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a graph of test results showing the prevention of calcium uptake by treatment of cells with protamine where the cells have been subjected to free radical attack and the protamine concentration is 5 μM. FIG. 2 is a graph of test results showing the effect of treatment in accordance with the present invention using different concentrations of protamine. FIG. 3 is a graph of test results showing the prevention of calcium uptake by treatment of cells with protamine where the cells have been metabolically inhibited and the protamine concentration is 5 μM. FIG. 4 is a graph of test results showing the prevention of calcium uptake by treatment of cells with polybrene where the cells have been subjected to free radical attack and the polybrene concentration is 25 μM. FIG. 5 is a graph of test results showing the prevention of calcium uptake by treatment of cells with polybrene where the cells have been metabolically inhibited and the polybrene concentration is 25 μM. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention involves a method for reducing the uptake of calcium by mammalian cells which are under the influence of a noxious stimuli. The type of noxious stimuli which create calcium uptake include, for example, metabolic inhibition, anoxia, ischemia and free radical attack. The following detailed description will be limited to reducing calcium uptake in cells subjected to metabolic inhibition or free radical attack with it being understood by those skilled in the art that the method has wide application to any situation where a cell is undergoing calcium uptake or influx in response to a noxious stimulus. The method in accordance with the present invention requires that the cell surface be treated with a sufficient amount of a cationic agent to alter the surface charge of the cell to reduce or prevent the uptake of calcium caused by the noxious stimuli. The amount of cationic agent which is used will vary depending upon the particular cationic agent, the particular cell type, the type of noxious stimulus to which the cell is being exposed, and the particular treatment process, ie. in vivo or in vitro treatment. The specific amount can be easily determined experimentally for each different situation. Some general guidelines with respect to amounts of cationic agents will be given below in connection with the description of specific examples. The mammalian cell types which are amenable to treatment by the present invention include any mammalian cell which undergoes calcium uptake when exposed to noxious stimuli. The invention is especially well-suited for treating cells, such as muscle cells, which have a sarcolemma. Exemplary cells include cardiac myocytes, in which the uptake has been directly demonstrated. Other cells which have been demonstrated to have calcium leak channels would be expected to respond similarly, e.g. dystrophic skeletal muscle(12). The cationic agents which are suitable include organic cations such as protamine, dodecyltrimethylammonium bromide(DDTMA), polymyxin B sulfate and polybrene. The greater the cationic charge, the more effective the agent. It is preferred that the cation carry as large a positive charge as possible without causing damage to the cell surface or otherwise disrupting the cell environment, especially when treatment is conducted in vivo. Organic cations with relatively small positive charge are not preferred. Gentamicin and other aminoglycoside antibiotics are not preferred because of their relatively low cationic charge. It was found that relatively large amounts (1.5 mM) of these types of cationic agents were required in order to obtain any significant levels of calcium uptake inhibition. The procedure for exposing the cell surface to the cationic agent can vary widely provided that a sufficient amount of cationic agent is present to alter the cell surface sufficiently to reduce the uptake of calcium. For in vitro situations, the cationic agent is simply added to the cell culture. The concentration of cationic agent in the cell culture preferably will range from 5 μM to 50 μM for strong cationic agents. For example, cell culture concentrations of protamine at levels of 5 μM and above were found to completely prevent calcium overload. For in vivo situations, the cationic agent is preferably added to a pharmaceutically acceptable solution which is administered to the mammal. The cationic solution is preferably administered intravenously. The concentration of cationic agent in the pharmaceutically acceptable solution is chosen so that the ultimate concentration of cationic agent in the environment immediately surrounding the cell will be at least 5 μM. It is preferred that the minimum amount of cationic agent be utilized which is effective in eliminating calcium uptake so that any adverse effects on other cells in the body are minimized. Suitable pharmaceutically acceptable solutions include saline or glucose solutions. The concentration of cationic agent in the pharmaceutically acceptable solution will range from about 5 μM to about 50 μM. Examples of practice are as follows: EXAMPLE 1 The following example demonstrates the use of protamine to prevent the uptake of calcium by neonatal rat cardiomyocytes exposed to hydrogen peroxide. Protamine is a strong polycationic polypeptide used extensively for heparin reversal after cardiopulmonary bypass. The drug is known to be negatively inotropic. The neonatal rat cardiomyocytes were cultured according to the procedure described by Frank et al.(13). Ca fluxes were measured by an on-line isotopic technique (13). The myocytes were cultured onto scintillant-containing discs which were mounted in a flow cell so that the cells were in direct contact with perfusate. The flow cell was placed between two opposing spectrophotometer tubes. Cell-associated Ca was then recorded in counts per minute. 45 Ca 2+ is a low energy beta-emitter. The radioactivity contained within the perfusate is counted with very low efficiency (<5%) whereas that within the cells is counted with an efficiency of 39%. In all of the examples the cells were initially perfused with non isotopic solution to remove any debris. Perfusion with 45 Ca 2+ containing solution was then commenced at 10 ml/minute and continued until the cells were labelled to asymptote. This normally took 25-30 minutes. The flow cell was then drained and refilled with a solution containing hydrogen peroxide. The cells were then incubated for 60 minutes with continuous recording of 45 Ca labeling (no flow) prior to washout with non-isotopic perfusate. After asymptotic labeling with 45 Ca, the cells were perfused with a solution containing protamine sulfate at varying concentrations. This did not significantly alter Ca uptake. The flow cell was then drained and refilled with a solution containing 50 μM H 2 O 2 and protamine. The procedure was repeated with protamine in varying concentrations: 1 μM (n=4); 5 μM (n=6) and 50 μM (n=6). At the end of each experiment the discs were removed from the flow cell, allowed to dry and the cells were scraped onto a pre-weighed piece of filter paper. This was placed in an oven (>100° C.) overnight and then weighed, permitting determination of the cellular dry weight. The specific activity of each isotopic solution was measured in a spectrophotometer (Beckman Instruments) and cell-associated Ca was expressed in mmoles/kg dry cellular weight. The cell cultures were maintained at 37° C. At a concentration of 1 μM, protamine had no effect. At 5 μM, protamine completely prevented the Ca overload. Increasing the concentration above 5 μM had no additional effect. The results of the test for a protamine concentration of 5 μM is shown in FIG. 1. FIG. 2 shows the test results for various concentrations of protamine. The effect of protamine, as described in this example was completely inhibited by neutralizing its positive charge with heparin. It is believed that the agent must have a positive charge which is sufficient to alter surface charge of the outer sarcolemmal leaflet. This penetration is necessary in order for the cation to exert its effect at the cell surface. EXAMPLE 2 The following example demonstrates the use of protamine to prevent the uptake of calcium by neonatal rat cardiomyocytes which are metabolically inhibited. Exposure of neonatal rat cardiomycytes to 0.05 mM iodoacetic acid (IAA), as a glycolytic inhibitor, and 0.5 mM 2-deoxyglucose (2-DOG), as a non-metabolizable substrate, produces a graded depletion in intracellular ATP and induces a significant Ca leak. In the following example involving metabolic inhibition, these two compounds were included in the incubation medium. 2-DOG was added directly and IAA was added from a 1 M stock solution, dissolved in water. The concentration in the culture media was 0.5 mM for 2-DOG and 0.05 mM for IAA. The metabolically inhibited cells were treated with protamine in the same manner as Example 1. The results were similar to Example 1, i.e. protamine did not exert a significant effect at concentrations below 5 μM. At concentrations of 5 μM and higher, protamine provided a dramatic drop in calcium uptake. The results of this example are summarized and shown in FIG. 3. EXAMPLE 3 The following example demonstrates the use of polybrene (hexamedronium bromide) to prevent the uptake of calcium by neonatal rat cardiomyocytes which have been exposed to hydrogen peroxide or are metabolically inhibited. Polybrene is a synthetic polycationic compound which is commercially available. The magnitude of the positive charge borne by the molecule is less than that of protamine. The same procedures were followed as in Examples 1 and 2, except that polybrene was substituted for protamine. Polybrene also inhibited the calcium leak caused by either hydrogen peroxide or metabolic inhibition. The threshold concentration above which inhibition was significant was 25 μM. The results of the tests for the polybrene/hydrogen peroxide combination are summarized and displayed in FIG. 4. The result for the polybrene/metabolic inhibition combination are shown in FIG. 5. EXAMPLE 4 In this example, dodecyltrimethylammonium bromide(DDTMA) was used as the cationic agent. The DDTMA was tested in the same manner as the preceding examples wherein neonatal rat cardiomyocytes were subjected to metabolic inhibition using iodoacetic acid and 2-deoxyglucose. The concentration of DDTMA was 50 μM. The DDTMA provided a significant inhibition of calcium uptake(14). EXAMPLE 5 In this example, polymyxin B sulfate (PXB) was used as the cationic agent. The PXB was tested in the same manner as Example 4. The concentration of PXB was 100 μM. In all cases, calcium uptake was substantially inhibited(14). EXAMPLE 6 The cationic agents of the present invention are particularly useful in those clinical situations where the heart has been deprived of its blood supply (ischemia) for variable periods of time and then resupply (reperfusion) is instituted. Such conditions are typical of acute coronary occlusion treated by dissolution of the occluding clot by various enzymes, coronary occlusion treated by coronary angioplasty or reperfusion after interruption of coronary blood flow during cardiac surgical procedures. All such situations have a high risk of producing cellular calcium overload during the reperfusion period. The overload frequently produces cell death and, if sufficient numbers of cells are involved, death of the patient. In the above situations, the cationic agents are added directly to the reperfusion solution at a concentration found to be effective in preventing calcium overload under in vitro conditions, i.e. 5 μM for the most effective cations. At these concentrations the negative inotropic effect will be minimal and, when present, will be rapidly reversed when the cationic agent is discontinued. Prevention of calcium overload in accordance with the present invention will increase the chance of cardiac cell survival in response to reperfusion. Such survival is important since heart muscle is incapable of regeneration and non-reversible cell damage leads to heart failure and/or death. Having thus described exemplary embodiments of the present invention, it should be noted by those skilled in the art that the within disclosures are exemplary only and that various other alternatives, adaptations and modifications may be made within the scope of the present invention. Accordingly, the present invention is not limited to the specific embodiments as illustrated herein, but is only limited by the following claims. BIBLIOGRAPHY 1. Farber J L: Calcium dependence of toxic cell death: A final common pathway. Science 1979;206:700-702. 2. Bourdillon, P D V; Poole-Wilson, P A, (1981) Effects of ischaemia and reperfusion on calcium exchange and mechanical function and mechanical function in isolated rabbit myocardium. Cardiovasc Res; 15: 121-130. 3. Nayler, W G; Grau, A; Slade (1976) A protective effect of verapamil on hypoxic heart muscle. Cardiovasc Res; 10:650-622. 4. Allen, D G; Orchard, C H (1983) Intracellular calcium concentration during hypoxia and metabolic inhibition in mammalian ventricular muscle. J. Physiol (London); 339: 107-122. 4. 5. Chien, K R; Engler, R (1990) Superoxide dismutase enhances recovery following myocardial ischemia. Am J Physiol; 248: H637-H643. 6. Farber, J L (1979) Calcium dependence of toxic cell death: a final common pathway. Science; 206: 700-702. 7. Tani, M (1990) Mechanisms of Ca 2+ overload in reperfused ischemic myocardium. Annu Rev Physiol; 52:543-559. 8. Knopf, H; Theising, R; Moon, C H; Hirche, H J (1990) Continuous determination of extracellular space and changes of K + , Na + , Ca 2+ , H + during global ischaemia in isolated rat hearts. J. Mol Cell Cardiol; 22:1259-1272. 9. Ziegelstein, R C; Sweier, J L; Mellits, E D, Younes, A; Lakatta, E G; Stern, M D; Silverman, H S (1992) Dimethylthiourea, an oxygen radical scavenger protects isolated cardiac myocytes from hypoxic injury by inhibition of Na-Ca exchange and not by its antioxidant effects. Circ Res; 70:804-811. 10. Coulombe A; Lefevre I A; Baro I; Coraboeuf E: Barium- and calcium permeable channels open at negative membrane potentials in rat ventricular myocytes. J Membr Biol 1989; 111:57-67. 11. Benham C D, Tsien R W: A novel receptor-operated Ca 2+ -permeable channel activated by ATP in smooth muscle. Nature 1987; 328: 275-278. 12. Fong P, Turner P R, Denetclaw W F, Steinhardt R A: Increased activity of calcium leak channels in myotubes of Duchenne human and mdx mouse origin. Science 1990: 250: 673-676. 13. Frank, J S; Langer, G A; Nudd, L M and Seraydarian, K. The myocardial cell surface, its histochemistry and the effects of sialic acid and calcium removal on its structure and cellular ionic exchange. Circ. Res. 41: 702-714, 1977. 14. Clague J. R. et al.: Cationic Amphiphiles Prevent Calcium Leak Induced by ATP Depletion in Myocardial Cells. Circulation Research, Vol 72, No. 1, January 1993.

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This application claims the benefit of U.S. Provisional Patent Application No. 60/346,972 filed Jan. 9 th 2002. FIELD OF THE INVENTION The present invention relates to fast cook pasta machines. Specifically, fast cook pasta machines with automatic pasta loading for variable sized portions. BACKGROUND OF THE INVENTION Conventional methods of pasta cooking involve the hydration and cooking of pasta via immersion in boiling water. Boiling water having a temperature of approximately 100° Celsius begins to flash, therefore in order to increase the cooking temperature beyond 100° Celsius pressure vessels are required. Pressure cooking at the resulting increased temperatures creates a dramatic decrease in the required cooking time. Previous fast pasta cooking apparatus have no means for automatic pasta loading of a variable sized portion and are relatively energy inefficient as they discharge the heat energy of the vapor released upon depressurization of the pressure cooking chamber. Also, the previous designs utilize hinged trap doors for cooked pasta discharge. These hinged doors added manufacturing complexity/expense and increased the machines manual cleaning requirements. Previous attempts at supplying fresh pasta from an automatic or semi-automatic machine have suffered from the inability to properly dispense dry pasta portions, measured from a bulk supply, into the cooking chamber. Previous solutions include supplying a plurality of portion chambers each pre-loaded with the pre-determined pasta portions. These designs suffer from the drawback of having only a limited number of pre-determined pasta portions available prior to requiring reloading. Also, the size of the pre-determined portions is difficult to modify and or swiftly reload once the plurality of pre-determined portion chambers are in place (a smaller portion size would require manual metering). SUMMARY OF THE INVENTION The present invention solves problems with prior on-demand fast-cook pasta machinery by supplying a method and apparatus for sampling a pre-determined amount of bulk product from a hopper into a variable sized cavity which upon filling with the bulk product is isolated from the hopper and the contents discharged by a series of gravity assisted mechanisms into a cooking chamber. The cooking chamber is pressurizable via inlet and outlet ball valves and water inlet and vapor outlet valves. Preheated water is introduced into the cooking chamber from a boiler and the cooking pressure and temperature maintained for a specified period. When the cooking period has ended, the cooking chamber is depressurized and the cooked pasta transferred to a post cook chamber via the cooker exit valve. Heat energy present in vapor created by depressurization of the cooker which would otherwise be wasted is directed through a condenser through which the inlet water supply passes thereby transferring energy as a preheating of the inlet water supply. The post cook chamber holds the pasta in an unpressurized environment for further final cooking/hydration. A water rinse may be applied to remove starch that has transferred to the cooking water. A circular plug drain provides a simple and sanitary exit path for the cooked pasta. Specific pasta configurations used in combination with the apparatus enable reduced cycle times (quick cooking) and problem free transport through the apparatus. BRIEF DESCRIPTION OF THE FIGURES One embodiment of the invention is disclosed by the figures as follows: FIG. 1 is a partial front view of the bulk product supply module of the apparatus. FIG. 2 is a partial side view of the bulk product supply module of the apparatus. FIG. 3 is a top view of the bulk product supply module of the apparatus. FIG. 4 is a collection of isometric views of various pasta forms for use with the apparatus. FIG. 5 is an electrical schematic of the apparatus. FIG. 6 is an electrical schematic of the apparatus. FIG. 7 is a layout schematic for an electrical panel of the apparatus. FIG. 8 is a process diagram for the apparatus. FIG. 9 is an isometric outside view of the apparatus. DETAILED DESCRIPTION The cooking machine may be configured for institutional/commercial use or for example, in consumer self-service embodiments configured for coin or debit/charge operation. Upon entry of a pre-selected amount of money and/or credit and actuation of a start command the machine may be configured to initiate an automated fast pasta preparation cycle. In addition to preparing pasta ready to eat, the machine may be configured to prepare pasta to a pre-selected pre-cooked level—ready for quick re-heating/final preparation at a later time and or location. As shown in FIGS. 1-3 , a hopper 2 mounted above the cooking area of the machine 14 contains bulk product 1 , for example, dry, frozen, semi-hydrated and or partially cooked or pre-cooked pasta. The hopper 2 volume may be configured to hold enough bulk product 1 so that repeated fillings during a single extended period of operation are not required. When loaded with bulk product 1 the hopper 2 is aligned precisely by a pair of receptacles 13 which key it so that a bottom hopper outlet matches the top opening of a portion cavity. At the hopper outlet, the portion cavity is filled by bulk product 1 exiting the hopper 2 under force of gravity. The volume of the portion cavity determines the portion size of the bulk product 1 processed each cycle. The portion cavity volume is set by a ram assembly 3 movable via, for example, an electrical solenoid or a pneumatic cylinder 4 . The height of the ram assembly 3 is configurable, for example, via a gear and screw assembly 15 which may be manually or electrically driven. The portion cavity is isolatable from the hopper 2 by a means for isolation, for example, a shutter or a disc 5 . The disc 5 is rotatable into and out of a blocking position, which isolates the hopper 2 from the portion cavity. Rotation of the disc 5 may be controlled, for example, by a second pneumatic cylinder 8 which drives a gear rack 7 which turns a spur gear 6 that rotates the disc 5 . The disc 5 is preferably able to slice through the bulk product 1 , cutting it if necessary. At the start of a cooking cycle, the disc 5 is actuated and the disc 5 rotates and isolates the portion cavity from the hopper 2 full of bulk product 1 . The ram assembly 3 is then actuated to drop thereby allowing bulk product 1 in the portion cavity to exit the portion cavity 100 under gravity into an opening of a carriage 9 . Because bulk product 1 , for example strands of pasta, might fall at an angle and remain skewed or otherwise unevenly fill the carriage 9 , carriage 9 is oversized. When filled, the carriage 9 is displaceable by, for example, by a third pneumatic cylinder 10 . The carriage 9 moves horizontally to a location above a delivery tube 11 . As the carriage 9 moves above the delivery tube 11 , the bulk product 1 drops into the delivery tube 11 by force of gravity. When the bulk product 1 has exited, the carriage 9 retracts, moving back to a position ready for the next cycle of bulk product 1 exiting the portion cavity. The delivery tube 11 , filled with bulk product 1 , is then actuated to rotate via a fourth pneumatic cylinder 16 to a 90° upward location wherein the bulk product 1 slides out of an open bottom end of the delivery tube 11 and is interrupted by a horizontal shutter, for example, a ball valve, which consolidates the bulk product prior to entry into the cooking chamber 12 upon actuation of the horizontal shutter. The shutter is actuated by a fifth pneumatic cylinder (not shown) Once filled, the cooking chamber 12 begins a cooking cycle pre-configured for the bulk product 1 in relation to the cooking characteristics of the selected bulk product 1 and the size of the bulk product 1 known from the volume setting of the portion cavity. For example, spaghetti strands may be used as the bulk product 1 configured for a portion size of between three and five ounces dry weight. Operation of a cooking cycle according to the process diagram shown in FIG. 8 starts with the apparatus already primed with water 30 supplied to a condenser coil 32 of the condenser 34 . The water supply 30 is preferably filtered and pressure regulated. The water supply 30 traveling through the condenser coil 32 is heated by exhaust vapors exiting the cooking chamber 12 after previous cooking cycles that is collected into the condenser 34 . Water exiting the condenser coil 32 is pressurized by pump 40 and directed through a check valve 42 into the boiler 50 and also upon demand via rinse valve 44 into the post cooker 70 during cooked pasta rinse sequences. The boiler 50 has a water level control via a level switch 54 , for example a lumenlite type level sensor, float switches, ultrasonic switches, capacitance level indicator or other form of level indication means. The boiler 50 is heated by a boiler heater 52 , for example an electric heater coil. The temperature generated in the boiler 50 is sensed by temperature probe 56 . As the water is heated the pressure increases, monitored by boiler pressure probe 58 which may include a configurable pressure switch or a relative pressure output signal. As a failsafe against over pressure, the boiler 50 has a boiler pressure relief valve 60 which will safely relieve over pressure states in the boiler 50 in the event of control failure. When desired for a cooking or cleaning rinse cycle, heated/pressurized water may be delivered to the cooking chamber 12 via actuation of transfer valve 62 . The cooking chamber 12 is similarly configured with a cooking chamber heater element 22 , cooking chamber temperature probe 24 and cooking chamber pressure probe 26 . The cooking chamber heater element 22 maintains a preset temperature during a cooking cycle utilizing the cooker temperature probe 24 and or the cooker pressure probe 26 switch or pressure signal output. To prevent flashing of the super heated water, the transfer valve 62 may be interlocked with the inlet ball valve 18 and outlet ball valve 20 which both must be closed along with cooker relief valve 28 prior to opening of the path from the boiler 50 . Manual cooker chamber pressure relief valve 61 provides a failsafe against over pressure occurring in the cooking chamber 12 . When a cooking cycle has been completed, the cooker relief valve 28 is actuated to create a connection between the cooking chamber 12 and a condenser chamber 34 so that the resulting steam from super heated liquid in the cooking chamber 12 may be safely and energy efficiently cooled in the condenser 34 to atmospheric pressure and the thermal energy therein transferred to the incoming water in the condenser coil 32 . With the pressure inside the cooking chamber 12 equalized, the outlet ball valve 20 may be opened whereby the contents of the cooking chamber 12 exit by force of gravity to the post cooker 70 . The heated liquid and cooked bulk product 1 may be held in the post cooker 70 for a further time interval. The cooked bulk product 1 may be rinsed with water and drained via rinse valve 44 which dilutes any starch which may have separated from the bulk product 1 during cooking. When a time interval has expired, a drain valve 72 , for example a plug valve, is actuated allowing the cooked bulk product 1 and water to exit into a colander 74 wherein the water is strained away to drain 80 . Also, any condensed water from the vapor in the condenser 34 is drained away to drain 80 as is any liquid moving past the pressure relief valves 60 and 61 . Bulk product 1 used with the present invention may include pasta formed of any edible grain, not limited to wheat. The pasta may be pre-cooked, semi-cooked or partially cooked. Cook time of the pasta is a function of the wall thickness, surface area, hydration and or level of pre-cooking of the pasta. Heat transfer and hydration of the pasta occurs faster in pasta formed with thinner walls and increased surface area. Examples of pasta shapes are shown on FIG. 4 . The length of the pasta of any given shape may be selected for consumer preference within the bounds of the machines ability to accept the pasta lengthwise and widthwise through the hopper outlet and then throughout the apparatus as designed. As quick cook times are desirable, any limiting characteristic of the pasta with respect to quick cooking may be made up for by increasing or decreasing another characteristic as the case may be to obtain an end result acceptable cooking time. To enable transport through the machine, the pasta should have at least limited rigidity or be of a shorter length so that pasta that might be of lesser rigidity and therefore subject to bending cannot, even if bending occurs, block the pasta flow path. The hopper 2 is configurable with baffles (not shown) or other means for use with shorter or longer lengths of pasta, the baffles preventing the pasta supply from becoming tangled by blocking off excess lateral free space in the hopper 2 , according to the length of the pasta selected. Where pasta approaching cubic or spherical shapes is used, the baffles are not required because any pasta bending or tangling that occurs will not tend to cause blockage of the pasta flow path. The present invention may be used with a wide range of specific types of pasta including pasta with characteristics that, in a preferred embodiment may include: a wall thickness T of between 0.012 and 0.08 inches. Wider widths W requiring proportionally wider pasta flow paths through the apparatus. a bore ranging in diameter D from 0.01 and 0.4 inches. a length L ranging from 0.375 to 10 inches. Longer lengths L requiring proportionally longer pasta flow paths through the apparatus. surface area and cross sectional thickness T enabling cooking within a range of 4 to less than 1 minute. Controls 104 and operational interlocks for the pasta machine may be hard wired or programmed via a Programmable Logic Controller (PLC). An example wiring schematic for use with a PLC controlled embodiment, showing electrical solenoids, sensors and switches is shown in FIGS. 5-7 . In one embodiment, the housing has a portion size indicator 110 and a dry weight indicator 112 . FIG. 9 shows the outside of the present invention. Machine 14 has a housing 106 . Located in the housing 106 are a plurality of vents 102 . Controls 104 and an operator touch screen 108 are located on the housing 106 . Additionally, machine 14 has a finished product dispensing port 114 . In the preferred embodiment, the housing has promotional panels 116 where logo sponsorship or other information may be displayed. For example, the machine user may wish to display nutrition or other information. The present invention has been described in only a single demonstrative embodiment of which many others exist. The invention is entitled to a range of equivalents and is to be limited only by the scope of the following claims.

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CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 61/098,952, filed on Sep. 22, 2008, which is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION [0002] The following relates to multi-modality tomographic imaging and more particularly to data processing systems for multi-modality imaging. BACKGROUND OF THE INVENTION [0003] Computed tomography (CT) is a medical imaging method or modality employing tomography, i.e., imaging by sections or sectioning, created by computer processing. Digital geometry processing can be used to generate a three-dimensional image of the inside of an object from a series of two-dimensional X-ray images taken around a single axis of rotation. CT data can be manipulated to demonstrate various bodily structures based on their ability to block an X-ray beam. [0004] Magnetic Resonance Imaging (MRI) can provide more contrast between different soft tissues than CT, making it especially useful in neurological, musculoskeletal, cardiovascular, and oncological imaging. MRI employs radio frequency (RF) fields to alter the static magnet induced magnetic alignment of the subject nuclei, for example hydrogen atoms, in the subject to produce a rotating magnetic field. This field can be detected and used to produce images of the subject. [0005] Positron emission tomography (PET) is a nuclear medicine imaging technique or modality, which can produce a three-dimensional image of functional processes in the body, for example the functioning of an organ. In PET, a radioactive tracer radioisotope is introduced into a subject, typically by injection. The positron emitting radioisotope occurs at a higher concentration in regions of high cellular metabolic activity. When an emitted positron encounters a free electron, the positron and electron may annihilate into two gamma photons which inherently provides higher signal to noise ratio than single photon emission imaging. These gamma photons can be detected by scintillation crystals, i.e., a material that emits light upon absorbing the gamma photons. The light emitted from the scintillation crystal can then be converted to electrical charge by an electronic light sensor, such as a photomultiplier tube (PMT) or avalanche photodiode (APD). The light sensor converts the light emitted by the scintillation crystal into a time varying stream of charge, i.e. an exponentially decaying current with decay time representative of the scintillation crystal. The resulting current produces a measurable electrical pulse; either current or impedance converted voltage may be used to measure the resulting total charge originating in the light sensor. Based on the time coincidence of the electrical pulses and the total energy measurements, three-dimensional images of the measured concentration of the tracer in the subject's body can be produced. [0006] It can be beneficial to combine different modalities. For example, it can be beneficial to combine a CT scanner and a PET scanner in order to provide information about the functioning of an organ and information about the anatomical structures surrounding the organ. A scanner combining a CT modality and a PET modality can be referred to as a multi-modality scanner or a PET-CT scanner. A problem exists in multi-modality scanners, because multi-modality scanners require the signal architecture to accommodate concurrent operation of the modalities. Accommodation of concurrent operation of the modalities can result in less than optimized signal architectures for each individual modality. [0007] The signal processing electronics used with the photo detectors in a commercial PET-CT scanner use vacuum tube based photomultiplier tubes (PMTs) to convert the light from individual scintillation crystals into electrical signals. However, for the development of a combined MRI-PET scanner, the photomultiplier tubes need to be replaced with another type of photo detector insensitive to the time varying electromagnetic fields of an MRI system. One candidate photodetector, which is MRI compatible, is an Avalanche photodiode (APD) biased in the linear range. The APD photo detector does not have the large signal gain achievable using photomultiplier tubes; typically PMTs are operated with anode gains on the order of 10 6 . Commercially available APDs used in PET detectors and are typically operated linearly with a much lower gain in the range of about 100 to 200. [0008] A need exists, therefore, for a data processing system for multi-modality imaging. It would be desirable to provide a system, method and/or apparatus to optimize the signal gain from an Avalanche photodiode in an multi-modality MRI-PET scanner. SUMMARY OF THE INVENTION [0009] One embodiment relates to a method that can include scanning a subject with a combined magnetic resonance imaging (MRI)/positron emission tomography (PET) scanner, using an analog to digital converter to discrete time sample a signal from a photo detector, cancelling one or more poles of the signal with a digital infinite impulse response filter implemented with fixed-point arithmetic inside a field programmable gate array, and using the modified signal to generate an image of the subject. The signal can be approximated as a sum of exponentials. One or more of the one or more poles can remain uncancelled, and the method can further include using the uncancelled pole as an input to an algorithm. The algorithm can be a digitial timing algorithm, a crystal localization algorithm, and/or a total energy algorithm. One or more of the one or more poles can remain uncancelled when a detected photon count rate is greater than 50 kcps. The infinite impulse response filter z-transform for the field programmable gate array implemented single pole/zero digital filter can be described mathematically by the equation [0000] H  ( z ) = K 1 - K 2 1 - K 3  z - 1 [0000] for an idealized model of a single exponential defined detector signal, wherein z represents the complex variable e sT , K 1 represents a digital constant coefficient associated with the input, K 2 represents a digital constant coefficient, K 3 represents the coefficient associated with the past input and output samples. The photodetector can be an avalanche photodiode. The avalanche photodiode can be biased in the linear range. The method can further include measuring a signal tail remaining in the modified signal on a per photo detector basis or on a multiple combination of photo detectors basis, and using a least squares error fit of the measured signal to tune the digital coefficients of the digital infinite impulse response filter. The method can further include storing the tuned digital coefficients in nonvolatile memory or in volatile memory for later PET data acquisitions. Prior to using the analog to digital converter to discrete time sample the signal, the method can further include cancelling one or more poles of the signal with an analog pole/zero filter. The method can further include using a sum of exponentials approximation to model a remnant tail of the detector signal remaining after approximate analog pole/zero cancellation. The sum of exponentials approximation can use the predicted statistical mean or expected value of the integrator reset time constant of the application specific integrated circuit (ASIC) charge sensitive amplifier (CSA) as the analog pole/zero circuit time constant. [0010] Another embodiment relates to a computer program product for a combined magnetic resonance imaging (MRI)/positron emission tomography (PET) scanner, the product can include: a computer-readable medium; a processing module residing on the computer-readable medium and operative to cancel one or more poles of a signal from a photo detector with a digital infinite impulse response filter implemented with fixed-point arithmetic and a display module residing on the computer-readable medium and operative to cause the display of an image of a subject based on the signal. The signal can be approximated as a sum of exponentials. One or more of the one or more poles can remain uncancelled, and the processing module can be further operative to use the resulting signal as an input to an algorithm. The algorithm can be a digitial timing algorithm, a crystal localization algorithm, and/or a total energy algorithm. One or more of the one or more poles can remain uncancelled when a detected photon count rate is greater than 50 kcps. The digital infinite impulse response filter can employ a z-transform described mathematically by the equation [0000] H  ( z ) = K 1 - K 2 1 - K 3  z - 1 [0000] for an idealized model of a single exponential defined detector signal, wherein z represents the complex variable e sT , K 1 represents a digital constant coefficient associated with the input, K 2 represents a digital constant coefficient, K 3 represents the coefficient associated with the past input and output samples. The photo detector can be an avalanche photodiode. The avalanche photodiode can be biased in the linear range. The processing module can be further operative to measure a signal tail remaining in the modified signal on a photo detector basis or on a multiple combination of photo detectors basis, and to use a least squares error fit to tune digital coefficients of the digital infinite impulse response filter. The processing module can be further operative to store the tuned digital coefficients in a nonvolatile or volatile memory for later PET data acquisitions. [0011] Another embodiment relates to a system for a combined magnetic resonance imagining (MRI)/positron emission tomography (PET) scanner, the system can include: a display device for displaying an image of a subject; a processor communicatively coupled to the display and operative to provide the image to the display device, wherein the processor cancels one or more poles of a signal from a photo detector with a digital infinite impulse response filter implemented with fixed-point arithmetic. The signal can be approximated as a sum of exponentials. One or more of the one or more poles can remain uncancelled, and the processor can be further operative to use the uncancelled pole as an input to an algorithm. The algorithm can be a digitial timing algorithm, a crystal localization algorithm, and/or a total energy algorithm. One or more of the one or more poles can remain uncancelled when a detected photon count rate is greater than 50 kcps. The digital infinite impulse response filter can employ a z-transform described mathematically by the equation [0000] H  ( z ) = K 1 - K 2 1 - K 3  z - 1 [0000] for an ideal model of a single exponential defined detector signal, wherein z represents the complex variable e sT , K 1 represents a digital constant coefficient associated with the input, K 2 represents a digital constant coefficient, K 3 represents the coefficient associated with the past input and output samples. The photo detector can be an avalanche photodiode. The avalanche photodiode can be biased in the linear range. The processor can be further operative to measure a signal tail remaining in the modified signal on a photo detector basis or on a multiple combination of photo detectors basis, and to use a least squares error fit to tune digital coefficients of the digital infinite impulse response filter. The processor can be further operative to store the tuned digital coefficients in a nonvolatile or volatile memory for later PET data acquisitions. [0012] Many other aspects and examples will become apparent from the following disclosure. BRIEF DESCRIPTION OF THE DRAWINGS [0013] In order to describe various aspects, examples, and inventive embodiments, the following figures are provided. [0014] FIG. 1 depicts a block diagram of the electrical signal path of an APD based detector using an analog pole/zero circuit combined with a discrete infinite impulse response filter for approximate tail subtraction to improve high count rate operation with a limited analog to digital converter (ADC) input range. [0015] FIG. 2 depicts a block diagram of the electrical signal path of an avalanche photodiode based detector using a discrete infinite impulse response filter for tail subtraction to improve accuracy at moderate count rates. [0016] FIG. 3 depicts magnitude of the infinite impulse response filter H(z) used to cancel single pole exponential tail from an avalance photodiode/charge sensitive amplifier based detector. [0017] FIG. 4 depicts the ideal phase Fourier spectrum of an infinite impulse response filter H(z) used to cancel the single pole exponential tail from an avalanche photodiode/charge sensitive amplifier based detector. [0018] It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. DETAILED DESCRIPTION OF THE INVENTION [0019] The functions described as being performed at various components can be performed at other components, and the various components can be combined and/or separated. Other modifications can also be made. [0020] All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. Numerical ranges include all values within the range. For example, a range of from 1 to 10 supports, discloses, and includes the range of from 5 to 9. Similarly, a range of at least 10 supports, discloses, and includes the range of at least 15. [0021] Thus, the following disclosure describes data processing systems, methods, and apparatus for multi-modality imaging, including a system, a method, and an apparatus for optimizing the signal to noise ratio from an APD based detector in the presence of the time-varying electromagnetic field originating from the MRI modality. Many other examples and other characteristics will become apparent from the following description. [0022] One embodiment relates to a signal processing system that can combine both analog and digital pole/zero circuits and processes for the PET electronics for a combined MR/PET modality. The system can be used in the field of nuclear medical imagining. The system can enable the signal processing hardware to achieve a higher count rate capability than systems employing either an analog circuit or a digital pole/zero filter algorithm employed individually. [0023] The lower gain of the APDs requires the use of low noise electronics to be able to measure accurate timing of the annihilation photons for a PET modality. In the specific application where an analog charge sensitive amplifier (CSA) is used to integrate the APD charge derived from crystal scintillation light, an analog continuous reset of the integrator can be achieved by a large effective impedance in parallel with the integrating feedback element, a capacitor. This integrator's reset time can be set larger than the collection time both to measure the full photon yield and to minimize the current noise density due to the feedback impedance, Rf. From a macroscopic signal view, the end result with an APD/crystal-based detector and CSA is that an integral exponential rise is shorter than the reset time. This parallel resistor-capacitor (RC) results in an exponential signal tail necessarily much longer than that required to the measure the full light emission of the scintillation crystal. Although a gated low impedance reset circuit, i.e., a gated integrator, can be used to reduce the integrated charge signal, the gating logic contains higher frequency signal components that need to be shielded in this specialized application, since the PET detectors are in such close proximity to the receiving MR electronics and are a noise source for the MR modality that must be minimized. For low noise and simplicity for a large number of channels, the integration reset function for this application consists of an analog parallel RC. [0024] Referring to FIG. 1 , a block diagram of the electrical signal path of an avalanche photodiode based detector using an analog pole/zero circuit combined with a discrete infinite impulse response filter for tail subtraction to improve high count rate operation is depicted. Scintillation detector 101 with bias 102 generates an electrical signal. The signal is transmitted to analog pole/zero circuit 103 , which comprises an operational amplifier with passive feedback and gain elements. The analog pole/zero circuit could be any of the recognized types that one of skill in the art could envision to effectively create a circuit with one dominant pole and one dominant zero. Circuit 103 has pole/zero function 104 , which can be given according to Equation 1 in its continuous Laplace Transform equivalent form. [0000] s + 1 τ 1 s + 1 τ 2 . Equation   1 [0025] In Equation 1, s represents the continuous domain complex frequency variable σ+jω, τ i represents [a single zero, pole cancellation constant, used to cancel the dominant signal tail from the CSA reset circuit, and τ 2 represents the substituted circuit single pole time constant after the original pole from the reset circuit has been cancelled by zero, τ i . [0026] Circuit 103 is connected to cable driver/buffer 105 . The analog pole/zero cancelled signal is discrete-time sampled by Analog to digital convert (ADC) 105 . Digital IIR filter 107 can be used to improve the count rate performance of the crystal localization/energy algorithm 108 and timing algorithm 109 at high count rates. The localization routine is used to determine which crystal absorbed the gamma photons from a weighted combination of all light sensors associated with the APD/scintillation crystal detector. The number of crystals to light sensors in the APD/scintillation crystal detector is much greater than 1:1 for reasons of economic necessity. At a high detector count rate, signal tails from previously detected gamma photons are the source of measurement errors for determining event position, total event evergy, and the gamma photon's time-of arrival. The time-of-arrival circuit is used to determine if two detected gamma photons are in time coincidence of each other, on the order of 20 ns or less for modern PET scanners. [0027] In nuclear spectroscopy, the exponential signal tail caused by an ideal integrator analog reset circuit can be eliminated by applying what is known as a pole/zero circuit in a following gain stages, which is shown in block diagram form in the first half of FIG. 1 . If it is assumed that the scintillation detector signal is of first-order modeled as a signal exponential or pole of value 1/τ 1 , the long tail resulting from the detector preamplifier can be cancelled by the zero of the pole/zero circuit leaving a remnant pole time constant 1/τ 2 of the pole/zero circuit. If the CSA is implemented in discrete form, the time constant of the resetting pole may be measured and an accurate cancellation is possible for a large number of channels. If the CSA is implemented in a custom application specific integrated circuit (ASIC), the reset time constant may be cancelled, not because the absolute time constants are known, but because the lithography and processing cause the component values of the capacitances and effective resistances of the integrator and pole/zero cancellation circuits to track within a small area even though the absolute values may deviate by as much as 50%. [0028] According to one embodiment, discrete-time filters have been developed to emulate their analog continuous counterparts. The analog pole/zero filter described above may also be implemented as a discrete filter that is nearly equivalent to the time-sampled analog pole/zero impulse response given sufficient accuracy of the digital coefficients for the filter. The system can use a combination of analog and digital pole/zero processing to achieve the benefits of both methods when used in a distributed system for a combined MR/PET modality. [0029] An advantage of an analog pole/zero cancellation directly at the detector before the signal is transmitted over a transmission cable to the processing unit is that the peak activity level that can be linearly processed with a fixed ADC analog input range is higher than if the detector signals are transmitted with slow exponential reset tails. If the long reset tail τ i remains, then the photopeak signal needs to be appropriately scaled so that multiple pileup events do not cause the analog input range of the ADCs (typically 1 vpp or 2 vpp for a typical embodiment) to be exceeded. A pileup event is defined as a measured gamma photon event that contains at least some of the remnant energy of past scintillation events before previous scintillation events' signals have been reset to within 1% of the reference signal baseline level. The significance of the pileup events on the time-of-arrival and event localization measurement is best understood by modeling the input signals from the detectors as a random Poisson process in time. [0030] If only the digital pole/zero is implemented directly from the CSA, the highest acceptable count rate is lower than if the digital pole/zero algorithm is combined with the analog pole/zero circuit. In practice, this may necessitate that the 511 Kev photopeak signal be lowered up to 5 times compared to an analog pole/zero filter applied to the APD detector signal prior to signal transmission as shown in FIG. 1 . For a large distributed system this may cause distorted signals in the PET electronic signals due to the unrelated modality RF signals from the MR. There can be a remnant signal tail remaining from the analog pole/zero cancellation due to the component tolerances both in the CSA and in the analog pole/zero circuit. [0031] Various embodiments of the system, method, and apparatus can use an analog pole/zero filter to allow an increased signal level at the interface between the PET detectors and processing unit in the PET modality of a combined MR/PET modality. [0032] Various embodiments of the system, method, and apparatus can use a sum of exponentials approximation to model the remnant signal tail of the detector signal after the analog pole/zero cancellation. In the envisioned embodiment, the statistical mean or expected value of the single pole value of the Application Specific Integrated Circuit's (ASIC's) (CSA) reset time constant is used as the expected value of the pole time constant. The remnant signal tail resulting from AC coupling time constants and mismatch of the analog circuits can remain. [0033] Various embodiments of the system, method, and apparatus can use a digitial infinite impulse response (IIR) filter implemented with fixed point arithmetic inside a field programmable gate array (FPGA) to cancel many poles of the signal approximated as a sum of exponentials, which is used as an input to a digital timing algorithm, crystal localization algorithm, and total energy algorithm. The embodiment will reduce measurement errors at single photons count rates of greater than 50 kcps. The analog pole/zero cancelled signal is discrete-time sampled by an ADC after appropriate Nyquist bandwidth limiting. The digital IIR filter is used to improve the count rate performance of the crystal localization and timing algorithms at greater than 50 kcps for the PET electronics in a dual mode MR/PET gantry. [0034] Various embodiments can include a method that measures the remaining signal tail on a per signal basis during a routine gantry setup and use a least square error fit to tune the digital coefficients of the filter coefficients automatically during gantry setup to optimize the count rate capability of the PET signal path in the combined MR/PET gantry. The optimal coefficients can be determined at low system count rates, less than 20 kcps per signal, where the remnant signal tails can be minimized through an iterative process by acquiring a histogram of each signal tail, automatically readjusting the digital coefficients, followed by subsequent histogram periods. The coefficients are stored in nonvolatile memory for later PET data acquisitions scans at normal and high count rates. [0035] The system, according to certain embodiments, is of particular use in a combined MR/PET modality where the narrowband MR electronics generate wideband electromagnetic signal content that is potentially coupled into different signal path points in the PET architecture. The system improves signal quality at the long cable interface and in the alter amplification stages. [0036] The analog pole/zero filtered signals can have a higher bandwith due to the substituted pole than the unfiltered CSA detector signals in order to improve the signal risetime and time resolution in the PET application. These higher frequency spectral components radiate more easily at the cable interface thus potentially impacting the MRI unless effective shielding is implemented. [0037] Referring to FIG. 2 , a block diagram of the electrical signal path of an avalanche photodiode based detector using a discrete infinite impulse response filter for tail subtraction to improve accuracy at moderate and high count rates is depicted. Scintillation detector 201 with bias 202 generates an electrical signal. The signal is transmitted to analog pole/zero circuit 203 , which comprises passive networks and an operational amplifier. Circuit 203 is connected to cable driver/buffer 204 . The analog pole/zero cancelled signal is discrete-time sampled by analog to digital converter (ADC) 205 . Digital IIR filter 206 can be used to improve the count rate performance of the crystal localization/energy algorithm 207 and timing algorithm 208 at moderate and high count rates. Digital IIR filter 206 can be a single pole/zero digital filter and can comprise a field programmable gate array (FPGA) employing a z-transform filter described mathematically in the form of Equation 2, for an ideal single exponential defined signal originating from a CSA/scintillation crystal detector combination. [0000] H  ( z ) = K 1 - K 2 1 - K 3  z - 1 . Equation   2 [0038] In Equation 2, z represents the complex frequency variable e sT , K 1 represents a constant coefficient, K 2 represents a scaling coefficient, K 3 represents the scaling filter coefficient associated with the last discrete output value of the IIR filter. [0039] In the embodiment shown in FIG. 2 , the system count rate is low enough that the dynamic range of the ADC is not approached at the scanner maximum count rate. The analog pole/zero circuit, at this point, becomes unnecessary, if the CSA integrator is assumed linear. The digitally implemented pole/zero filter is used to effectively cancel both the integrator circuit reset time and the AC coupling time constants from the APD/scintillation crystal based detectors. [0040] FIG. 3 depicts one possible embodiment of the IIR filter. The magnitude of the Fourier Transform of the infinite impulse response filter, H(z), used to cancel the single pole exponential tail from an an ideal avalanche photodiode/charge sensitive amplifier based detector. [0041] FIG. 4 depicts the phase response of the Fourier Transform of one embodiment of the infinite impulse response filter, H(z), used to cancel the single pole exponential tail from an ideal avalanche photodiode/charge sensitive amplifier based detector. [0042] A processor as used herein is a device for executing stored machine-readable instructions for performing tasks and may comprise any one or combination of hardware and firmware. A processor may also comprise memory storing machine-readable instructions executable for performing tasks. A processor acts upon information by manipulating, analyzing, modifying, converting or transmitting information for use by an executable procedure or an information device, and/or by routing the information to an output device. A processor may use or comprise the capabilities of a controller or microprocessor, for example. A processor may be electrically coupled with any other processor enabling interaction and/or communication there-between. A processor comprising executable instructions may be electrically coupled by being within stored executable instruction enabling interaction and/or communication with executable instructions comprising another processor. A user interface processor or generator is a known element comprising electronic circuitry or software or a combination of both for generating display images or portions thereof. A user interface comprises one or more display images enabling user interaction with a processor or other device. [0043] An executable application comprises code or machine readable instructions for conditioning the processor to implement predetermined functions, such as those of an operating system, a context data acquisition system or other information processing system, for example, in response to user command or input. An executable procedure is a segment of code or machine readable instruction, sub-routine, or other distinct section of code or portion of an executable application for performing one or more particular processes. These processes may include receiving input data and/or parameters, performing operations on received input data and/or performing functions in response to received input parameters, and providing resulting output data and/or parameters. A user interface (UI), as used herein, comprises one or more display images, generated by a user interface processor and enabling user interaction with a processor or other device and associated data acquisition and processing functions. [0044] The UI also includes an executable procedure or executable application. The executable procedure or executable application conditions the user interface processor to generate signals representing the UI display images. These signals are supplied to a display device which displays the image for viewing by the user. The executable procedure or executable application further receives signals from user input devices, such as a keyboard, mouse, light pen, touch screen or any other means allowing a user to provide data to a processor. The processor, under control of an executable procedure or executable application, manipulates the UI display images in response to signals received from the input devices. In this way, the user interacts with the display image using the input devices, enabling user interaction with the processor or other device. The functions and process steps herein may be performed automatically or wholly or partially in response to user command. An activity (including a step) performed automatically is performed in response to executable instruction or device operation without user direct initiation of the activity. An object or data object comprises a grouping of data, executable instructions or a combination of both or an executable procedure. [0045] The technology can take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment containing both hardware and software elements. In one embodiment, the invention is implemented in software, which includes but is not limited to firmware, resident software, microcode, etc. Furthermore, the invention can take the form of a computer program product accessible from a computer-usable or computer-readable medium providing program code for use by or in connection with a computer or any instruction execution system. For the purposes of this description, a computer-usable or computer readable medium can be any apparatus that can contain, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device. The medium can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device) or a propagation medium (though propagation mediums in and of themselves as signal carriers are not included in the definition of physical computer-readable medium). Examples of a physical computer-readable medium include a semiconductor or solid-state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk-read only memory (CD-ROM), compact disk-read/write (CD-R/W) and DVD. Both processors and program code for implementing each as aspect of the technology can be centralized and/or distributed as known to those skilled in the art. [0046] The above disclosure provides examples and aspects relating to various embodiments within the scope of claims, appended hereto or later added in accordance with applicable law. However, these examples are not limiting as to how any disclosed aspect may be implemented, as those of ordinary skill can apply these disclosures to particular situations in a variety of ways. [0047] Although the present invention has been described in considerable detail with reference to certain preferred versions thereof, other versions are possible. Therefore, the spirit and scope of the appended claims should not be limited to the description of the preferred versions contained herein. [0048] The reader's attention is directed to all papers and documents which are filed concurrently with this specification and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference. [0049] All the features disclosed in this specification (including any accompanying claims, abstract, and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features. [0050] Any element in a claim that does not explicitly state “means for” performing a specified function, or “step for” performing a specific function, is not to be interpreted as a “means” or “step” clause as specified in 35 U.S.C §112, sixth paragraph. In particular, the use of “step of” in the claims herein is not intended to invoke the provisions of 35 U.S.C §112, sixth paragraph.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application is a division of my copending application Ser. No. 301,625, filed Oct. 27, l972 now U.S. Pat. No. 3,909,880 which is a continuation-in-part of my copending application Ser. No. 244,027, filed Apr. 14, 1972 now U.S. Pat. No. 3,928,891. BACKGROUND OF THE INVENTION This invention relates to an improved molding apparatus for molding articles such as food material patties from a moldable material such as meat, fish and the like and having improved means for maintaining pressure on the material to produce firmly packed, shaped articles together with means for using the pressure of the material itself as a hydraulic fluid to produce fluid tight seals in the pressure portions of the apparatus. The invention also relates to an improved ram structure for applying flowing and shaping pressure to the moldable material with the ram having improved seals for its sides which include the bottom so that the pressure of the material itself operating through the seals tends to prevent leaking of material around the ram. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view partially broken away of a molding apparatus embodying the invention. FIG. 2 is a view similar to FIG. 1 but showing the movable parts in opposite positions from the positions shown in FIG. 1. FIG. 3 is an enlarged fragmentary sectional view through a ram and associated structure. FIG. 4 is a front elevational view of the ram of FIG. 3. FIG. 5 is a plan view, partially broken away for purposes of illustration, of one front corner of the ram of FIG. 3. DESCRIPTION OF THE PREFERRED EMBODIMENT In the embodiment illustrated the apparatus includes a hopper 11 having a lower section in which is provided a generally horizontally extending compression chamber 13 having a reciprocable pressure ram 123. Located at the bottom of the hopper lower section with a forward end extending into the bottom of the compression chamber 13 is a slidable valve plate 129. On top of the valve plate 129 and slidable relative thereto is the pressure means ram 123 adapted to be reciprocated between the extreme forward position of FIG. 3 and return to apply pressure to pressure flowable moldable material 124 when this material is in the compression chamber 13 as shown in FIG. 3. Beneath the valve plate 14 on the side opposite the ram 123 is a horizontally reciprocable mold plate 17 that has a plurality of transversely aligned mold openings 18 each of which is circular so as to provide circular patties 19. The mold plate 17 is reciprocated between the filling position of FIGS. 1 and 3 and the extended patty removal position of FIG. 2 by upper 20 and bottom 21 racks having teeth 22 and 23 facing each other and engaging an intermediate pinion 24 so that the two racks 20 and 21 move in opposite directions as illustrated and described in prior U.S. Pat. Nos. 3,417,425 and 3,654,665, both assigned to the same assignee as the present application. There are provided two pairs of racks 20, racks 21 and pinions 24 on opposite sides of the apparatus. The projecting ends of the bottom racks 21 are connected to the end of the mold plate 17 by a mounting strip 36 attached to the racks 21 at flange ends 38 and an overlying bar 165. The assembly of strip 36, bar 165 and intervening end of the mold plate is releasably secured by a pair of connecting pins 166. The racks and attached mold plate 17 are reciprocated back and forth with no pause except for instantaneous reversal of motion at the end of each reciprocation. The various types of apparatus embodying the invention may utilize units of one or more mold plates, pairs of racks 20 and 21, rams 123 and other cooperating portions of the apparatus as desired to produce either single patties or a multiplicity of patties or similar articles. As illustrated in FIGS. 1 and 2 where the operating parts of the machine are at their two limits of movement the apparatus is driven by a motor and lever system mounted on and housed within a cabinet 29. This cabinet contains a conventional electric motor and gear reducer combination 30 that drives a shaft 37 through a series of chains 31 and 32 and pulleys 33, 34 and 35. Mounted on the shaft 37 and rotatable therewith is a short link 39 that is rotatably connected at its outer end by a pin 40 to a longer link 41 whose opposite end is rotatably connected by a pin 42 to an intermediate point on an elongated operating lever 43 having its lower end fulcrumed at 44. The upper or opposite end of the lever 43 is connected by a link 45 to a block 46 attached to the upper rack 20. There are two sets of links 39, 41 and 45 and levers 43 and blocks 46 with the second set being located on the opposite side of the cabinet 29. Extending rearwardly from each block 46 is a drive bar mounting bracket 47 with a mounting being provided also on each side of the machine and between which extends a transverse drive bar of the type disclosed at 52 in the above U.S. Pat. No. 3,654,665. In order to adjust the location of the path of movement of the ram 15 so as to adjust the extent of its stroke there is provided a compression adjustment rod 59 that extends through a bracket 60 and is provided with an adjustment knob 61 for rotating the rod 59. With this arrangement rotating the knob 61 and thus the rod 59 moves the ram 123 either forwardly or rearwardly and thereby determines the relative position of the ram 15 at the extremes of its path of movement illustrated by the forwardmost position in FIG. 3. Each valve plate 129 has on its end adjacent the compression chamber 13 a sloped surface 142 against which the compressed material 124 presses to move the valve plate away from the compression chamber 13 and provide access to the mold opening 18 as shown in FIG. 3. This opening movement of the valve plate 129 is opposed by a helical spring 65 that is preloaded to the desired degree to provide any required amount of resistance to movement of the valve plate. Each spring 65 is concentric about its valve spring rod 66 with one end of each spring 65 bearing against the valve plate 129 and the opposite end bearing against an adjustable stop 68. The position of the tubular adjustable stop is regulated by rotating the valve adjustment handle 71. As described and claimed in the above U.S. Pat. No. 3,654,665 the hopper 11 is provided on its oposite sides with rotatable mover devices (not shown) for urging the moldable material and particularly adhesive ground meat 139 toward each ram 123. These devices are moved in increments by reciprocable levers 80 and a linkage 81 in the form of a metal strip hinged to and connecting the levers 80. In order to reciprocate one lever 80 and thus a second lever through the linkage 81 there is provided a short linkage 82 connecting the extended end of one lever 80 to a larger linkage 83 whose opposite end is mounted by a hinge pin 84 to the cabinet 29 of the machine. One end of each linkage 82 and 83 is connected by a hinge 85 which in turn is connected to one end of a short linkage whose other end is hingedly connected to a small rack 87 that is slidably held in a recess 88 on one side of the upper rack 20. While the levers and linkages for operating the ram or rams are in two sets on opposite sides of the machine there is only one set of linkages and rack 87 for operating the levers 80 and the rack 87. These of course are the linkages and hinge connections 81-86. Similarly, there is only one rack 87 on the one side of the machine. The teeth 89 of the rack 87 engage the teeth 90 in a reciprocable rotatable pinion 91. This pinion on its outer side operates within the confines of a cover plate 92. The pinion 91 is reciprocated in a back and forth arcuate movement by the longitudinal reciprocation of the small rack 87 to reciprocate an agitator within the lower section of the hopper 11 as disclosed in the above prior U.S. Pat. No. 3,654,665. In order to reciprocate the levers 80 and the small rack 87 the linkage lever 83 is connected at about its midpoint by a linkage 94 to a linkage 95 between the ends thereof, one end of which is hingedly mounted at 96 to a fixed extension 97 on the machine and the other end hingedly connected at 98 by a linkage 99 to the main operating lever 43 on its side of the machine. Because of the relative points of connection of the linkages 83, 94, 95 and 99 to each other and then to the operating lever 43 the levers 80 and the small rack 87 move at a faster rate than do the side racks 20 that operate each ram. To provide for this increased speed the recess 88 in which the small rack 87 is located is considerably longer than the rack itself. Thus as shown in FIG. 1 in one extreme position of the operating parts the small rack 87 is at the right extreme of its recess 88 while in the opposite position of the operating parts as shown in FIG. 2 the small rack 87 is at the other end of its recess. In the illustrated embodiment a knockout cup 100 is provided for each mold opening 18 to remove the formed patties 19 from the openings 18 and drop them onto a conveyor 174 (FIG. 2) as disclosed and claimed in the above copending application Ser. No. 301,625, filed Oct. 27, 1972. The inverted knockout cups 100 of which one is provided for each mold opening 18 are mounted on a flat strip with an overlying angle bar. The angle bar has a horizontal part overlying the strip and a vertical part. The cup mounting structure is bolted by a bolt 103 at each end to an enlarged section 112 of a vertical slide rod 104. Attached to each side of the frame 29 of the machine is a horizontally extending cam plate 105 (FIGS. 1 and 2) having a downwardly and forwardly sloped cam surface 106. There is provided one cam plate 105 on each side of the machine and each cam plate at the bottom of the inclined cam surface 106 has a horizontal extension 107 terminating in a horizontal outwardly extending right angle flange 108 acting as a stop. When the knockout cups 100 and associated elements are in their lowermost positions as shown in FIG. 2 with the cups 100 within the mold openings in removing patties 19 therefrom and depositing them on the conveyor 174 the side flanges 108 operate as forward stops for limiting the extent of movement of vertical bars 109 which are attached at each of their bottom ends to a slide block 110 that slides on the bottom rack 21. The two vertical bars 109 carry the inverted cup 100 knockout structure and are connected at their tops by a horizontally extending tie bar 111. In the illustrated embodiment there is enough friction and enough adhesion caused primarily by meat juices to carry the slide blocks 110 and structure attached to the slide blocks along with the side racks 21 until the blocks are stopped by end stops 29 and 108. When the bottom racks 21 have been retracted fully as shown in FIG. 1 so that the rear ends of the slide blocks 110 abut against the front of the machine frame 29 acting as a stop the knockout cups 100 structure will have been raised to its most elevated position by the rollers 113 (FIG. 1) being at the tops of the substantially parallel inclined cam edges 106. The mold plate 17 is also retracted so that the mold openings 18 are again in filling position (FIGS. 1 and 3). Then when the bottom racks 21 are projected forwardly after the mold openings 18 have been filled with ground meat to form the transverse series of patties the front edges of the vertical bars 109 engage the laterally extending stop flanges 108. At this location the side bars 109 and knockout structure carried thereby remain in knockout position while the side racks 21 and the attached mold plate 17 continue their forward movement. When the side racks 21 and attached mold plates 17 have reached the furthest extent of their forward movements the knockout cups 100 are then directly vertically aligned with the mold openings 18 and the shaped patties 19 therein. At this position the bottom ends of the slide rods 104 are over the vertical openings (not shown) in the top surfaces of the side racks 21. When this alignment of the rods 104 with the openings occurs side springs 119 attached to top flanges on the vertical rods 104 snap the knockout structure downwardly to the position shown in FIG. 1 where the cups 100 enter the mold openings 18 and dislodge the patties therefrom. On the return movement of the side racks 21 from their extended positions of FIG. 2 the side racks 21, mold plate 17, side bars 109 and knockout structure carried thereby move rearwardly as a unit. As can be seen in FIG. 2 the initial portion of this movement which is when the forward edges of the bars 109 first move rearwardly away from the side stops 108 causes the side rollers 113 (FIG. 1) to start up the upwardly inclined cam edges 106. This causes the knockout structure to be lifted raising the knockout cups 100 from their mold openings as at this stage the entire structure carried by the side bars 109 is moving at the same horizontal rate of speed as the mold plate 17 even though the mold plate 17 is traveling in a horizontal path while the knockout structure is traveling in an upwardly angled path due to the engagement of the rollers 113 with the inclined edges 106. By the time the rollers reach the top of the inclined edges 106 or the position shown in FIG. 1 the cups have been completely removed from the mold openings and the engagement of the rear edges 172 of the slide blocks 110 with the adjacent vertical surfaces of the machine frame 29 causes the blocks 110 and the knockout structure carried thereby to stop its rearward motion. The side racks 21 and the attached mold plate 17, however, continue their rearward motion until the mold openings 18 are again aligned with the mold fill slots as illustrated by the fill slot 173 in the embodiment of FIG. 3. As can be seen, the knockout or patty removal system is compact, simple in structure and very rapid as during its operation it moves with a horizontal component along with the mold plate and its drive structure. As shown in FIG. 3 the valve plate 129 comprises a solid plastic plate 140 for almost all of its length except that at the front it abuts against a portion 128 that is of steel. Also in the embodiment of FIG. 3 the forward edge of the plate front portion 128 is provided with a bottom substantially flat flange 141. This flange 141 when the valve plate 129 is in its forwardmost position is retained in a groove 143 in the bottom edge of the pressure plate 144. The mold plate 17 slides between this top pressure plate and a bottom pressure plate 145. FIGS. 3-5 illustrate embodiments of fluid seals operated by the pressure of the compressed moldable material which is here illustrated as food material. As illustrated, the ram 123 is sealed to the hopper 11 to prevent substantial leakage around the sides and bottom of the ram. The bottom of the ram is sealed by a transverse pressure bar 125 held in a vertical groove 126 so as to be movable relative to the bottom surface 127 of the ram. This bar 125 which may be made of steel is forced against the top surface of the front portion 128 of the valve plate 129 by the pressure of the meat 124 in the chamber 13. In order to subject the top part of the pressure bar 125 to this pressure of the meat 124 there are provided in the illustrated embodiment four upwardly extending passages 130 that communicate with the groove 126 in which the pressure bar 125 is located. Each of these plurality of passages 130 communicate at their upper ends with a forwardly extending passage 131 whose front ends are open to the pressurized material 124 in the chamber 13. Thus as the pressure in this chamber 13 builds up the pressure is transmitted by the material in the passages 130 and 131 as a hydraulic fluid to the top of the pressure bar 125. Thus the greater the pressure of the material 124 the greater the downward sealing force on the pressure bar 125. The pressure of the material 124 also forces the top surface 138 of the ram 123 into sealing engagement with the top of the compression chamber 13 (FIG. 3). The sides of the ram 123 are sealed by pressure members 132 which may also be made of steel and which each comprises a vertically extending rectangular plate 133 positioned within a similarly shaped groove 134 on each side surface 135 of the ram 123. Each plate 133 is provided with a centrally located stem 136 at about its midpoint slidably held in a similarly shaped opening 137 that extends inwardly of the groove 134 and communicates with a forward opening passage 131. Thus, as can be seen in FIG. 5 the passages 130, 131 and 137 all join so that the pressure of the material 124 in the compression chamber 13 operating through these passages simultaneously presses the bottom bar 125 and the side seal plates 133 into sealing engagement with the adjacent hopper surfaces. Having described my invention as related to the embodiment shown in the accompanying drawings, it is my intention that the invention be not limited by any of the details of description, unless otherwise specified, but rather be construed broadly within its spirit and scope as set out in the appended claims.

1a

CROSS REFERENCE TO RELATED APPLICATION This application claims the benefit under 35 U.S.C. 120 and 365(c) of co-pending prior International Patent Application No. PCT/US14/64847 filed on Nov. 10, 2014, which claims the benefit of U.S. patent application Ser. No. 14/076,348 filed on Nov. 11, 2013, which issued as U.S. Pat. No. 9,186,008 on Nov. 17, 2015. The patent applications identified above are incorporated herein by reference in its entirety to provide continuity of disclosure. FIELD OF THE INVENTION This invention relates to clothes hangers, and more particularly, to a clothes hanger used for hanging one or more articles of clothing with straps, such as tank tops, camisoles, bras, dresses and so forth, and/or for displaying accessories, such as necklaces, earrings and so forth. BACKGROUND OF THE INVENTION A clothes hanger is a device in the shape of human shoulders designed to facilitate the hanging of articles of clothing such as shirts, tops, jackets and so forth. Conventional hangers consist of wire hangers bent in a flattened triangle-like shape that continues into a hook at the top, wooden hangers cut into a boomerang-like shape or triangle-like shape having a hook protruding from the top, and plastic hangers molded into boomerang-like shape or triangle-like shapes with a hook located on top. Many hangers have notches or loops located thereon to hang an article of clothing having shoulder straps. Each strap is secured to a single notch or single loop located on opposite sides of the hanger. The article of clothing then spans the length of the hanger and the notches or loops keep the article of clothing from sliding off ends of the hanger. However, a problem with such conventional hangers is that only one article of clothing may be hung on a single hanger. This means multiple articles of clothing are hung sided by side (each on separate hangers) on a closet hanging rod, thereby taking up extra space in a closet. Therefore, a need exists for a clothes hanger that will allow a user to hang multiple articles of clothing thereon to conserve storage space while still making it easy to organize the articles of clothing for easy access to the clothing. SUMMARY OF THE INVENTION The primary object of the present invention is to provide a clothes hanger that will allow a user to hang multiple articles of clothing thereon to conserve storage space while still making it easy to organize the articles of clothing for easy access to the clothing. The present invention fulfills the above and other objects by providing a hanger having a plurality of hooks located thereon for hanging multiple tank tops or other strapped articles of clothing. A plurality of hanging hooks extends from opposite sides of the hanger along the length of each side of the hanger. When multiple articles of clothing are placed on each side of the hanger, a counter balance is created so when multiple tank tops or other strapped articles of clothing are stored on the hanger, the hanger remains level. By hanging multiple articles of clothing on the single hanger, horizontal storage pace in a closet is saved. The hooks may be retractable into the body of the hanger and/or hingedly attached to the body of the hanger. In addition, the clothes hanger of the present invention may be used to store and organize jewelry. An additional feature of the present invention is a base that allows the hanger to be displayed on a counter, dresser or other flat surface. 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 THE DRAWINGS In the following detailed description, reference will be made to the attached drawings in which: FIG. 1 is a perspective side view of a clothes hanger of the present invention; FIG. 2 is a front view of a clothes hanger of the present invention; FIG. 3 is a rear view of a clothes hanger of the present invention; FIG. 4 is a top view of a clothes hanger of the present invention; FIG. 5 is a perspective side view of a clothes hanger of the present invention having a base; and FIG. 6 is a perspective side view of a clothes hanger of the present invention having a base. DESCRIPTION OF THE PREFERRED EMBODIMENTS For purposes of describing the preferred embodiment, the terminology used in reference to the numbered components in the drawings is as follows: 1 . clothes hanger, generally 2 . first side of clothes hanger 3 . second side of clothes hanger 4 . center of clothes hanger 5 . horizontal angle 6 . apex 7 . rod hanging hook 8 . strap hanging hook 9 . rear surface of clothes hanger 10 . front surface of clothes hanger 11 . bottom surface of clothes hanger 12 . top surface of clothes hanger 13 . vertical angle 14 . base 15 . elongated arm 16 . top end of elongated arm 17 . bottom end of elongated arm 18 . top surface of base 19 . bottom surface of base 20 . perimeter edge of base 21 . panel 22 . aperture 23 . joint With reference to FIGS. 1-4 , a perspective side view, a front view, a rear view and a top view, respectively, of a clothes hanger 1 of the present invention are illustrated. The clothes hanger 1 comprises a first side 2 and a second side 3 meeting at a center 4 of the clothes hanger 1 and extending away from each other a predetermined distance. The first side 2 and second side 3 may be parallel to each other or the first side 2 and second side 3 of the clothes hanger 1 may angle downward from the center 4 to create a horizontal angle 5 and a substantially boomerang-like shape having an apex 6 . A rod hanging hook 7 extends upward from the center 4 of the clothes hanger 1 . The rod hanging hook 7 is used to hang the clothes hanger 1 in a closet from a hanging rod. At least two strap hanging hooks 8 are located on the first side 2 and at least two strap hanging hooks 8 are located on the second side 3 . Each strap hanging hook 8 located on the first side 2 is preferably located to mirror the location of each strap hanging hook 8 located on the second side 3 . For example, each strap hanging hook 8 is an equal distance from the center 4 of the clothes hanger 1 as compared to the countering strap hanging hook 8 located on the opposite side of the clothes hanger 1 . The placement or location of the strap hanging hooks 8 allows for the clothes hanger 1 to be counterbalanced so the clothes hanger 1 remains in a level position while hanging in a closet. The strap hanging hooks 8 located on the first side 2 may also be located on a surface that is opposite to a surface the strap hanging hooks 8 located on the second side 3 are located on. As illustrated here, the strap hanging hooks 8 located on the first side 2 are located on a rear surface 9 of the clothes hanger 1 and the strap hanging hooks 8 located on the second side 3 are located on a front surface 10 of the clothes hanger 1 . This further allows for the clothes hanger 1 to be counterbalanced so the clothes hanger 1 remains in a level position while hanging in a closet. However, although the strap hanging hooks 8 are illustrated as being located on the front surface 10 and the rear surface 9 of the clothes hanger 1 , the strap hanging hooks 8 may also be located on a bottom surface 11 of the clothes hanger 1 , a top surface 12 of the clothes hanger 1 and/or be notches located on a top surface 12 of the clothes hanger 1 . In addition, the first side 2 and second side 3 may angle outward from each other in the same or opposite directions to create a vertical angle 13 at the center 4 of the clothes hanger 1 . This vertical angle 13 provides for a further counter balance to the clothes hanger 1 . The hanger 1 of the present invention may also comprise at least one joint 23 located thereon, such as a hinge, locking hinge, male/female interlocking locking joint, pivot point or other type of engagement means that allows the hanger 1 to be collapsible for travel as illustrated in FIG. 2 . With reference to FIGS. 5 and 6 , a perspective side view and a front view, respectively, of a clothes hanger 1 of the present invention having a base 14 are illustrated. An elongated arm 15 having a top end 16 and a bottom end 17 extends downward from the center 4 of the clothes hanger 1 a predetermined distance where the bottom end 16 connects to a base 14 having a top surface 18 , a bottom surface 19 , and at least one perimeter edge 20 . At least one panel 21 may extend upward from the perimeter edge 20 and have at least one aperture 22 located thereon. A user may store earrings on the at least one panel 21 by connecting the earrings to the apertures 22 . It is to be understood that while a preferred embodiment of the invention is illustrated, it is not to be limited to the specific form or arrangement of parts herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and drawings.

1a

FIELD OF THE INVENTION The present invention relates to a pharmaceutical composition for use in treatment of a wide variety of malignancies in mammals. The composition of the present invention is non-toxic and targets cancer cells, as opposed to healthy peripheral cells. BACKGROUND OF THE INVENTION Plants may undergo instances of stress, which result in activation of complex genetic pathways that bring about physiological responses appropriate to the stress source. Common stresses to which plants are subjected include extreme UV radiation, osmotic shock, heat shock and pathogen attack. Stress hormones have evolved in plants, which are released in such times of stress and initiate various cascades which end in appropriate responses. Jasmonic acid (JA) and methyl jasmonate (MJ), belong to the group of natural plant stress hormones named “jasmonates” (Sembdner and Parthier, Annu. Rev. Physiol. Plant Mol. Biol., 44, 569-589, 1993). Jasmonic acid is crucial to intracellular signaling in response to injury and methyl jasmonate causes induction of a proteinase inhibitor that accumulates at low concentrations in response to wounding or pathogenic attacks (Farmer and Ryan, Proc. Natl. Acad. Sci., 87, 7713-7716, 1990). Jasmonates have been patented for a variety of uses in plant growth and crop improvement. Application of jasmonates can have a wide range of contradictory effects on virtually all plants. These effects range from inhibition of plant development to promotion of plant processes. U.S. Pat. No. 6,114,284 discloses use of jasmonic acid ester and giberellin to synergistically enhance plant growth and development. U.S. Pat. No. 5,436,226 discloses use of a jasmonate to inhibit sprouting and darkening in tubers after they have been picked, and U.S. Pat. No. 5,118,711 discloses use of methyl jasmonate to repel insects. Sodium salicylate (SA) is a plant stress hormone of another family, and a central mediator of plant defense responses to pathogens and to injury (Ryals et al., Plant Cell., 8, 1809-1819, 1996). One response to attack by a microbial pathogen, may be, for instance, programmed cell death termed the hypersensitive response (HR) which results in the formation of a zone of dead cells around the infection site. The layers of dead cells that surround the site of pathogen entry are thought to function as a physical barrier that inhibits further proliferation and spread of the pathogen. A subsequent step of the process involves synthesis of the plant stress hormone sodium salicylate, and accumulation of antimicrobial agents, such as pathogenesis-related proteins and phytoalexins (Dangl et al., Plant Cell, 8, 1793-1807, 1996; Mitler and Lam, Trends. Microbiol., 4, 10-15 1996). This programmed cell death in response to pathogen attack is reminiscent of programmed cell death known to occur in mammalian cells. Mammalian cells can die by “unscheduled” necrosis, which is caused by outside damage and results in cell explosion, or in the more organized manner of apoptosis, also termed “programmed cell death” or “cellular suicide” (Willingham, J. Histochem. Cytochem., 47, 1101-1109, 1999). In apoptosis, biochemical and morphological events are usually organized in a cascade of very specific and controlled steps, which include fragmentation of the nucleus and shrinkage of the cell, and end with complete splitting of the cell contents to apoptotic bodies (Stewart, J. Cancer Inst., 86, 1286-1295, 1994). The process of apoptosis is slower then necrosis and happens in a few hours or days, depending on the inducer. This kind of death may be regarded as “cell suicide” (Willingham, J. Histochem. Cytochem., 47, 1101-1109, 1999). Surprisingly enough, the plant stress hormone SA was able to induce intracellular biochemical events typical of a stress response in mammalian cells as well (Schwenger et al., Proc. Natl. Acad. Sci. USA, 4, 2869-2873, 1997; Schwenger et al., J. Cell. Physiol., 179, 109-114, 1999), and was able to induce apoptosis (programmed cell death) in cell lines of human myeloid leukemia, through activation of Caspase-3 (a mammalian cytoplasmic protease essential for the final steps of apoptosis) (Klampfer et al., Blood., 93, 2386-2394, 1999; Willingham, J. Histochem. Cytochem., 47, 1101-1109, 1999; Porter and Janicke, Cell Death Differ., 6, 99-104 1999). SA was likewise able to induce apoptosis in mammalian FS-4 fibroblasts (Schwenger et al., Proc. Natl. Acad. Sci. USA, 4, 2869-2873, 1997), and in human pancreatic cancer (McDade et al., J. Surg. Res., 83, 56-61 1999). The family of drugs of which salicylic acid is a member, non-steroidal anti-inflammatory drugs (NSAID), have potent chemopreventive activity (Morgan, Gut., 38, 646-648 1996; Peleg et al., Dig. Dis. Sci., 41, 1319-1326 1996; Vainio et al., Cancer Epidemiol. Biomarkers Prev., 6, 749-753, 1997). Many plant genes that respond to environmental and developmental changes are regulated by jasmonic acid, which is derived from linolenic acid by an octadecanoid pathway. Plant defense responses to certain wavelengths of ultraviolet radiation require activation of the octadecanoid defense signaling pathway (Conconi et al., Nature, 383, 826-829, 1996). The release of linolenic acid from the membrane into the cell, and its subsequent conversion to JA, is analogous to signaling pathways in mammalian cells, where releasing of arachidonic acid from the membrane results in synthesis of eicosanoids, such as prostaglandins (Needleman et al., Ann. Rev. Biochem., 55, 69-102 1986). Prostaglandins of the A and J series, which contain a cyclopentanone ring structure, are potent inhibitors of cell proliferation in vitro and are able to suppress tumorigenicity in vivo (D'Onofrio et al., Int. J. Cancer., 51, 481-488, 1992; Gorospe et al., Mol. Cell. Biol., 16, 762-770, 1996). The ability of prostaglandins to arrest growth in a diverse range of tumor cell lines has raised the possibility that they might be useful for treatment of human cancer (Sasaki and Fukushima, Anti-Cancer Drugs, 5, 131-138, 1994). Structural similarity exists between jasmonates and prostaglandins, since both are cyclopentanons, which suggests that JA and MJ may be potent against cancer cells. The present invention discloses use of members of the plant stress hormone family termed “jasmonates”, for suppressing and killing mammalian cancer cells that represent major types of human malignancies. To the best of the applicant's knowledge, jasmonates were never studied as anti-cancer agents. Since chemotherapeutic drugs for use in mammalian systems usually work by induction of apoptosis in cancer cells (Bailly et al., Leukemia., 11, 1523-1532, 1997), and jasmonates are thought to be involved in an apoptotic response to plant stress, the applicants tested the ability of jasmonates to suppress replication of mammalian cancer cell lines of clinical importance. The cytotoxicity of jasmonates was compared to that of the plant stress hormone sodium salicylate, which is known to be cytotoxic to mammalian cancer cells. Chemotherapeutic drugs are often so highly toxic as to leave the patient with numerous side-effects that seriously diminish the patient's quality of life and impair his function. Chemotherapy regimens can last several months and can be performed repeatedly in cases of relapse, leaving even an ambulatory patient with repeated periods of partial impairment of function. The need exists, therefore, for chemotherapeutic drugs with undiminished potency, yet with a higher degree of specificity towards malignant cells, and fewer side-effects. The present invention discloses use of jasmonate compounds to treat malignancies. Jasmonates are commonly found in minute quantities in many edible plants (Sembdner and Parthier, Annu. Rev. Physiol. Plant Mol. Biol., 44, 569-589 1993), such as tomato, potato, and pumpkin seeds, and thus are non-toxic. Jasmonates are shown by the applicants to be highly specific; inducing apoptosis in clinically important types of cancer cells, yet not effecting the proliferation of normal human cells, such as healthy lymphocytes. Jasmonates are additionally shown by the applicants to be effective in the treatment of lymphoma in a cancer model in mice. It is the object of the present invention to propose jasmonate compounds as a potent chemotherapeutic drug, with a high degree of specificity towards malignant cells. These and other objects of the present invention will become more apparent from the detailed description of the preferred embodiments, that follows below. In the present invention, the term “jasmonates” is intended to include the natural plant hormones jasmonic acid and methyl jasmonate, as well as any natural or synthetic derivative and isomers of jasmonic acid and of jasmone. These derivatives have: 1) a lower acyl side chain at C 3 (free acid or ester or conjugate) 2) a keto or hydroxy (free hydroxy or ester) moiety at the C 6 carbon 3) an n-pentenyl or n-pentyl side chain at C 7 . A variety of jasmonates may be used, and include but are not limited to those having the formula: wherein n is 0,1, or 2; R 1 is OH, alkoxy, O-glucosyl, or imino, R 2 is OH, O, alkoxy or O-glucosyl, R 3 , R 4 and R 5 are H, OH, alkoxy or O-glucosyl, and/or wherein R 1 and R 2 , or R 1 and R 4 together form a lactone, and further wherein the bonds between C 3 :C 7 , C 4 :C 5 , and C 9 :C 10 may be double or single bonds. SUMMARY OF THE INVENTION The present invention relates to a pharmaceutical composition useful for the treatment of cancer in mammals, comprising as an active ingredient a therapeutically effective amount of a jasmonate compound of the formula I: wherein: n is 0,1, or 2; R 1 is OH, alkoxy, O-glucosyl, or imino, R 2 is OH, O, alkoxy or O-glucosyl, R 3 , R 4 and R 5 are H, OH, alkoxy or O-glucosyl, and/or wherein R 1 and R 2 , or R 1 and R 4 together form a lactone, and further wherein the bonds between C 3 :C 7 , C 4 :C 5 , and C 9 :C 10 may be double or single bonds; or a derivative of said formula, wherein the derivative has at least one of the following: a lower acyl side chain at C 3 (free acid or ester or conjugate), a keto or hydroxy (free hydroxy or ester) moiety at the C 6 carbon, or an n-pentenyl or n-pentyl side chain at C 7 . According to a preferred embodiment of the present invention, the jasmonate is selected from methyl jasmonate, jasmonic acid, jasmone, 7-iso-jasmonic acid, 9,10-dihydrojasmonic acid, 2,3-didehydrojasmonic acid, 3,4-didehydrojasmonic acid, 3,7-didehydrojasmonic acid, 4,5-didehydrojasmonic acid, 4,5-didehydro-7-iso-jasmonic acid, cucurbic acid, 6-epi-cucurbic acid, 6-epi-cucurbic-acid-lactone, 12-hydroxy-jasmonic acid, 12-hydroxy-jasmonic-acid-lactone, 11-hydroxy-jasmonic acid, 8-hydroxy-jasmonic acid, homo-jasmonic acid, dihomo-jasmonic acid, 11-hydroxy-dihomo-jasmonic acid, 8-hydroxy-dihomo-jasmonic acid, tuberonic acid, tuberonic acid-O-β-glucopyranoside, cucurbic acid-O-β-glucopyranoside, 5,6-didehydrojasmonic acid, 6,7-didehydrojasmonic acid, 7,8-didehydrojasmonic acid, cis-jasmone, methyldihydroisojasmonate, dihydro-jasmone, amino acid conjugates of jasmonic acid, and the lower alkyl esters, the carrier ligand conjugates and the sterioisomers thereof. Further, according to a preferred embodiment of the present invention, the cancer to be treated is selected from prostate cancer, breast cancer, skin cancer, colon cancer, lung cancer, pancreatic cancer, lymphoma, leukemia, head and neck cancer, kidney cancer, ovarian cancer, bone cancer, liver cancer or thyroid cancer. Moreover, in accordance with a preferred embodiment of the present invention, the active ingredient is dissolved in any acceptable lipid carrier. Still further, in accordance with a preferred embodiment of the present invention, the composition additionally comprises at least one other chemotherapeutic agent. Additionally in accordance with a preferred embodiment of the present invention the composition is prepared for oral administration. In such embodiments, the composition is in a form selected from an emulsion, a solution, a capsule, a tablet. In another embodiment of the present invention, the composition is prepared for administration by injection. The composition is prepared so as to be suitable for injection intra-muscularly, intra-peritoneally, or intraveneously. Still further, in certain embodiments, the composition is prepared for topical administration. According to these embodiments, the composition is in a form selected from an ointment, a gel, or a cream. Moreover, in some embodiments of the present invention, the composition is prepared for administration by inhalation. In other embodiments, the composition is prepared for administration via a suppository. The present invention further provides a method for treatment of cancer in mammals, comprised of administering a pharmaceutical composition containing as the active ingredient a therapeutically effective amount of a jasmonate compound of Formula I: wherein: n is 0,1, or 2; R 1 is OH, alkoxy, O-glucosyl, or imino, R 2 is OH, O, alkoxy or O-glucosyl, R 3 , R 4 and R 5 are H, OH, alkoxy or O-glucosyl, and/or wherein R 1 and R 2 , or R 1 and R 4 together form a lactone, and further wherein the bonds between C 3 :C 7 , C 4 :C 5 , and C 9 :C 10 may be double or single bonds; or a derivative of said formula, wherein the derivative has at least one of the following: a lower acyl side chain at C 3 (free acid or ester or conjugate), a keto or hydroxy (free hydroxy or ester) moiety at the C 6 carbon, or an n-pentenyl or n-pentyl side chain at C 7 . BRIEF DESCRIPTION OF THE DRAWINGS The present invention is herein described, by way of example only, with reference to the accompanying drawings, wherein: FIG. 1 is a graph illustrating the cytotoxicity of plant hormones methyl jasmonate and jasmonic acid, compared with salicylic acid, as a measure of their concentration. Table 1 is a comparison of the level of toxicity effected by jasmonic acid, methyl jasmonate and salicylic acid on four malignant cell lines. FIG. 2 is a graph illustrating the activity levels of the apoptotic marker protein Caspase-3, in Molt-4 cells treated with jasmonic acid and methyl jasmonate. FIG. 3 illustrates fluorescence microscopy pictures depicting apoptotic changes in morphology of Molt-4 cells, after treatment with jasmonic acid and methyl jasmonate. FIG. 4 is a graph illustrating the specificity of the cytotoxic effect jasmonates exert on malignant cells, versus no effect on normal lymphocytes from healthy donors. FIG. 5 is a graph illustrating the cumulative percentage of survival of mice treated with jasmonates to prevent the formation of lymphomas, versus untreated mice. DETAILED DESCRIPTION OF THE INVENTION It is appreciated that the detailed description that follows is intended only to illustrate certain preferred embodiments of the present invention. It is in no way intended to limit the scope of the invention, as set out in the claims. The present invention describes use of jasmonates to prevent proliferation and induce death of malignant cells. Particularly preferred jasmonates include jasmonic acid [(−)-JA and/or (+)-7-iso-JA], methyl jasmonate, jasmone, and 9,10-dihydro-jasmonic acid and its lower alkyl ester. Other preferred jasmonates include 4,5-didehydro-7-iso-JA, 3,7-didehydro-JA, cucurbic acid (CA), 6-epi-CA, 6-epi-CA-lactone, 12-hydroxy-JA, 12-hydroxy-JA-lactone, 11-hydroxy-JA, 8-hydroxy-JA, homo-JA, dihomo-JA, 11-hydroxy-dihomo-JA, 8-hydroxy-dihomo-JA, tuberonic acid (TA), TA-O-β-glucopyranoside, CA-O-β-glucopyranoside, amino acid conjugates of JA, as well as the corresponding lower alkyl esters of each of these acids. The applicants have proven below, that two jasmonates, methyl jasmonate and jasmonic acid, have a positive therapeutic effect on malignant cells, yet do not harm normal cells such as normal circulatory lymphocytes. The following examples demonstrate that jasmonates are cytotoxic to four different types of malignant cells in culture, in doses that would be considered safe and attainable in mammals, and do not inhibit growth of healthy lymphocytes. The applicants have additionally proven, in Example 5, that jasmonates are effective in prolonging the lifetime of mice injected with lymphoma cells, resulting in a survival rate that is significantly higher than that of untreated mice (2.25 times the number of survivors than in the untreated group). EXAMPLE 1 Plant Stress Hormones are Cytotoxic for Four Human Transformed Cell Lines Four transformed cell lines of different histological lineages were exposed to one of three plant stress hormones. The cell lines chosen represent four types of cancer of widespread clinical importance. Molt-4 is a human T lymphoblastic leukemia cell line, SK-28 are human melanoma cells. LNCaP is an androgen-responsive human prostate adenocarcinoma cell line, and MCF7 is a human breast carcinoma cell line. All cell lines were purchased from ATCC (Rockville, Md.). All reagents were purchased from Sigma Chemicals (St. Louis, Mo.) unless otherwise stated. JA and MJ were dissolved in ethanol. All cell cultures were performed in RPMI-1640 with 10% fetal calf serum (Biological Industries, Beit-Haemek, Israel), and cells (except for Molt-4 and lymphocytes from the peripheral blood) were allowed to adhere prior to every treatment mentioned below. LNCaP, MCF7 and SK-28 cells (at 4×10 3 /well) and Molt-4 cells (at 1.5×10 4 /well) were seeded in 96-well plates and allowed to adhere overnight. Plant stress hormone at increasing concentrations was added as indicated below, and toxicity was measured after 24 hours using the CellTiter 96 Aqueous Non-Radioactive Cell Proliferation Assay (Promega, Madison, Wis.); an assay in which viable cells produce a colored product (for details on the protocol of this assay, see below). This assay is quantitative, as the amount of color produced is read using an ELISA reader. The highest non-toxic pharmacological concentration used in humans, of the nonsteroidal anti-inflammatory drug SA, is approximately 3 mM (Katzung, Lange Medical Book, Stamford, 1998). In order to compare the additional plant stress hormones JA Oasmonic acid) and MJ (methyl jasmonate) with SA, the same range of concentrations (0.5-3 mM) was chosen. These compounds at the aforementioned concentrations are not toxic for mice. Each cell line was incubated with each of these hormones at a concentration ranging from 0.5-3 mM for 24 hours, after which cytotoxicity was measured. The statistical significance of the results was determined (where appropriate) by two-tailed student's t-test, n=3. Results are presented as means ± standard deviation. In reference to FIG. 1, the cytotoxicity of each one of three plant hormones is plotted as a measure of its concentration. diamonds=Molt-4 lymphoblastic leukemia cells; squares=SK28 melanoma cells; triangles=LNCaP androgen-responsive prostate adenocarcinoma cells, circles=MCF7 breast carcinoma cells. Referring to FIG. 1A, all cell lines responded in a dose-dependent fashion to SA. Cytotoxicity of SA was significant, P<0.05, in Molt-4 lymphoblastic leukemia cells, SK28 melanoma cells and MCF7 breast carcinoma cells at all concentrations, and in LNCaP human prostate adenocarcinoma cells, from 1 mM and higher. SA was shown here to inhibit cell proliferation of different cancer cells from 20 to 40%, depending on the cell line. This finding is in agreement with similar reported observations, where SA inhibited growth of breast cancer cell lines, rat hepatoma and human fibroblasts cultures (Sotiriou et al., Anticancer Res., 19, 2997-3006 1999; Hial et al., J. Pharmacol. Exp. Ther., 202, 446-454 1977). A possible interpretation of this data is that SA causes stress in cancer cells, resulting in suppression of proliferation in those cells. JA and MJ were studied in comparison to SA in order to determine whether the effects of SA on cancer cells are common to plant stress hormones, and whether jasmonates would be deemed more effective than salicylic acid at targeting and inhibiting the growth of malignant cells. Referring to FIG. 1B, the responsiveness to JA was dose-dependent. The cytotoxicity of JA was significant, P<0.05, in Molt-4 cells from 1 mM and higher, in LNCaP and SK28 cells from 2 mM and higher, and in MCF7 cells at 3 mM. The order of sensitivity to JA was Molt-4>SK-28>LNCaP>MCF7. Referring to FIG. 1C, cytotoxicity of MJ was significant, P<0.01, in Molt-4 cells at all concentrations and in MCF7 cells at 3 mM; and at P<0.05 in LNCaP and SK28 cells from 2 mM and higher. The results presented here show that MJ caused the highest level of cytotoxicity. For instance, 0.5 mM of MJ induced 87.52% cytotoxicity in Molt-4 cells. The other cell lines responded to MJ in a dose-dependent way. The order of sensitivity was Molt-4>LNCaP>SK28>MCF7. Appropriate controls established that ethanol (in which JA and MJ were dissolved) by itself did not induce any cytotoxicity. Example 1 demonstrates that while cancer cells from various origins responded to plant stress hormones, their response was differential. Among the cell lines examined, Molt-4 responded strongly to JA (90% cytotoxicity at 3 mM) and MJ (90% cytotoxicity at 0.5 mM). Cytotoxicity Assay Used In Examples Inhibition of cell proliferation was determined by the CellTiter 96 Aqueous Non-Radioactive Cell Proliferation Assay (Promega, Madison, Wis.): Upon completion of a given experiment, MTS (a tetrazolium compound) at 333 μg/ml + phenazine methosulfate (at 25 μM) was added to each well of the 96-well plate for 1 hour at 37° C. This allowed for development of a color reaction in which dehydrogenases reduce the MTS in metabolically active cells. Since the cells were not washed before the addition of MTS, there were no potentially loosely adherent or non-adherent cells that could have been problematic. Soluble MTS formazan product was measured at a wavelength of 490 nm using a CERES 900 HDI ELISA reader (Bio-Tek Instruments, Inc, Highland Park, Vt.). Optical density is directly proportional to the number of living cells in culture. Cytotoxicity (%) was calculated in the following way: [(OD of control cells−OD of drug-treated cells)/OD of control cells]×100. EXAMPLE 2 Characterization of the Damage Induced by Jasmonates Since the same number of cells was aliquoted into each well initially, decreased optical density as measured in wells containing treated cells (above) reflects cellular death and/or decrease in the rate of proliferation. To distinguish between these two possibilities we employed an additional cytotoxicity assay which detects cell death by lack of trypan blue exclusion. Cells were incubated with 0.1% trypan blue for 2-5 minutes and the percentage of dead cells (those, which did not exclude the dye) was determined microscopically. Referring to Table 1 , among the plant hormones tested, MJ induced death most effectively in every cell line. MJ is more effective in killing human transformed cell lines than its non-methylated form JA (FIGS. 1B, 1 C and Table 1 ). SA suppressed proliferation in all cell lines, while JA induced death in lymphoblastic leukemia cells and suppression of proliferation in the other cells. In terms of relative susceptibility, Molt-4 cells are followed by SK28, LNCaP and MCF7 cells, in that order. Differential susceptibility of the different cell lines to the plant stress hormones suggests a specificity of the influence of those compounds on the cells. It is important to note the difference between SA and jasmonates in their influence on cancer cell lines. SA causes inhibition of cell proliferation in the tested cell lines, JA causes cell death in Molt-4 cells and inhibition of cell proliferation in SK28, LNCaP and MCF7 cells, whereas MJ causes death in all cell lines. These differences could be explained by different structures of plant stress hormones and/or by difference in biochemical events that those compounds induce in the cells. EXAMPLE 3 Jasmonates Induce Apoptosis in Molt-4 Cells Elevated levels of Caspase-3 are a specific marker of the apoptosis process (Porter and Janicke, Cell Death Differ., 6, 99-104, 1999). In order to definitively determine that the cause of cell death was apoptosis, the level of Caspase-3 activity was measured in cells after treatment with JA and MJ. Molt-4 cells were incubated with JA and MJ for 2, 4 and 14 hours, and levels of activity of the apoptosis-mediating protease, Caspase-3, were determined using the Caspase-3 (CPP32) protease assay kit (PharMingen, San Diego, Calif.) as suggested by the manufacturer. Briefly, 2×10 6 cells were lysed and resuspended in 100 μL of reaction buffer containing a fluorogenic Caspase-3 (CPP32) substrate Ac-DEVD-AMC. Reactions were incubated at 37° C. for 2 hours and samples were assayed at excitation wavelength of 360 nm and emission wavelength of 460 nm, in the FL600 Microplate Fluorescence Reader (Bio-Tek Instruments, Winooski, Vt., USA). Referring to FIG. 2, dose-dependent elevation of Caspase-3 activity was observed: (Diamonds=2 hours, squares=4 hours, triangles=14 hours.) As can be seen in FIG. 2, JA and MJ increased Caspase-3 activity significantly, P<0.05, at all concentrations and times. Referring to FIG. 2A, incubation with JA for 2 hours didn't induce an elevation in the level of Caspase-3. Referring to FIG. 2B, after 14 hours of exposure to MJ, the extent of death at 1 mM and above was such that Caspase-3 activity could not be determined. These results suggested that JA and MJ induced apoptotic death in Molt-4 cells. To confirm this fact, Molt-4 cells were treated with JA (2 mM) and MJ (0.5 mM) for 14 hours, and analyzed by fluorescence microscopy in order to detect essential morphological characteristics of apoptosis such as condensation and fragmentation of chromatin. Referring to FIG. 3, fluorescence microscopy pictures are shown depicting changes in cellular morphology within the nuclei of Molt-4 cells, after treatment with plant stress hormones JA or MJ. 5×10 5 cells/sample were harvested, then fixated by addition of a solution of phosphate-buffered saline (PBS) containing [3% paraformaldehyde and 0.1% Triton X-100], for one hour. Cells were stained for 10 minutes with DAPI (1 μg/ml). Nuclei were analyzed by fluorescence microscopy, (using a fluorescence microscope model. A×70 TRF, made by Olympus Optical, Japan) at a magnification of 1:400. Characteristic apoptotic nuclei are marked with arrows. Referring to FIG. 3A, untreated Molt-4 cells are shown. Referring to FIG. 3B, Molt-4 cells were treated with JA at 2 mM for 14 hours. Treatment with JA induced condensation and fragmentation of chromatin. Referring to FIG. 3C, Molt-4 cells were treated with MJ at 0.5 mM for 14 hours. Treatment with MJ completely destroyed nuclear morphology in almost all cells. These results confirm that JA and MJ caused apoptotic death in Molt-4 cells, based on the rise in caspase-3 activity, which is one of the features of apoptosis, and on characteristic morphological changes. SA was reported to induce apoptosis and activation of caspases in myeloid leukemia cell lines and in B-cell chronic lymphocytic leukemia cells. There is also evidence that SA enhances apoptosis and causes apoptosis in FS-4 cells via p38 (Schwenger et al., Proc. Natl. Acad. Sci. USA, 4, 2869-2873, 1997). In those studies different cell lines undergo apoptosis on incubation with concentrations of salicylates higher than those achieved in plasma of patients treated for inflammatory disorders. In the present invention, concentrations of salicylates were used, that are comparable to those achieved in the plasma. This can explain the difference between studies where SA induced apoptosis, and our results. EXAMPLE 4 Jasmonates are not Harmful to Normal Lymphocytes The results shown above prove that plant stress hormones possess the ability to adversely affect cancer cells. The effect of these plant products was tested on normal cells, to determine if jasmonates have an adverse cytotoxic effect on non-cancerous cells as well. Normal lymphocytes were separated from peripheral blood, as follows: Mononuclear cells (MNC) from venous blood of healthy donors were collected by Ficoll-Hypaque (Phamacia Fine Chemicals, Uppsala, Sweden) density gradient centrifugation. The resultant mononuclear cell preparation was allowed to adhere to plastic dishes to remove contaminant macrophages. The non-adherent peripheral blood lymphocytes were selected for use. Prior to treatment with JA and MJ, normal lymphocytes were stimulated by TPA (5 ng/ml) and PHA (0.8 μg/ml) for 48 hours, to cause the lymphocytes to proliferate (and so, be comparable to the immortal malignant cells). Normal lymphocytes and Molt-4 cells were seeded (at 1.5×10 4 /well) in 96-well plates. Jasmonates or salicylic acid were added at a concentration of 1 mM or 3 mM, and cells were incubated for 24 hours. Optical density representing viable cells was determined by the CellTiter 96 Aqueous Non-Radioactive Cell Proliferation Assay. Each plant stress hormone induced significant cytotoxicity in Molt-4 cells, P<0.05, while non of the hormones induced any significant cytotoxicity in normal lymphocytes. Referring to FIG. 4, normal blood lymphocytes (represented by solid bars) were practically not influenced by plant stress hormones, contrary to the Molt-4 transformed lymphoblastic leukemia cells (represented by open bars). FIG. 4A shows treatment with SA at concentrations of 1 mM and 3 mM. FIG. 4B shows treatment with JA at concentrations of 1 mM and 3 mM, and FIG. 4C shows treatment with MJ at concentrations of 1 mM and 3 mM. Refer to Table 1 as well, which illustrates the selectivity of jasmonates for malignant cells versus healthy cells. In this example, the influence of plant stress hormones on transformed lymphocytes (Molt-4 cells) was compared, versus their influence on normal lymphocytes extracted from peripheral blood. Normal lymphocytes (that had been stimulated by TPA/PHA to induce proliferation), were not influenced by SA and jasmonates, contrary to transformed lymphocytes. This data supports the potential use of plant stress hormones as selective anti-cancer agents. EXAMPLE 5 In-vivo Experiments in Mice Syngeneic lymphoma cells were injected into a test group and a control group of mice (strain C57BL). The injections were administered either sub-cutaneously, or intra-peritoneally. Methyl jasmonate was administered orally, by injection directly into the resultant tumor or into the peritoneum, and the effect on tumor progression and on the rate of survival, were analyzed. 400,000 EL-4 lymphoma cells were injected intra-peritoneally into 20 test mice, or 19 control mice, of the C57BL strain. Preliminary experiments had shown that methyl jasmonate at a dosage of 236-472 mg/kg. body weight was appropriate for prevention of tumoral growth. Therefore, methyl jasmonate was dissolved in a lipid carrier (0.4% Lipofundin, manufactured by B. Brown, Melsunger, Germany) and administered orally at a dosage of 236 mg/kg body weight. Administration was daily, via the drinking water, beginning with the day of injection of the lymphoma cells. 19 control mice received the lipid carrier only (0.4% Lipofundin), with no methyl jasmonate dissolved within. The survival time of each group of mice was measured (in days), and analyzed. Referring to FIG. 5, a Kaplan & Meier Survivorship Function graph is shown, illustrating the cumulative percentage of survival in each group, as the experiment progressed. Survival rates were significantly higher for the treated group (represented by crosses, and by the letter “T”), versus the control group (represented by circles, and by the letter “C”); as can be seen, for example, in the plateau of 50% survival reached by the treated group on the 33 rd day, as opposed to the plateau of 20% survival reached by the control group. The significance of these results was analyzed statistically, using two highly stringent statistical means of analysis, the Log-Rank Test and the Cox-Mantel Test. Each of these tests weighs numerically the importance of a death within one of the two groups of mice, on a given day, compared to the number of surviving mice in the whole. The significance of the results was deemed to be high, p=0.01492 for the Log-Rank Test, and p=0.00953 for the Cox-Mantel Test (wherein a result is considered significant if p<0.05). In conclusion, Examples 1-5 elucidate the effect of the structurally-diverse plant stress hormones, jasmonates and salicylate, on cell proliferation and viability in several diverse cancer cell lines. There were four major findings. Firstly, all the stress hormones investigated share the ability to adversely affect proliferation of cancer cells. Jasmonic acid (JA) induced death in lymphoblastic leukemia cells and caused suppression of cell proliferation in the other human cancer cells mentioned above. Methyl jasmonate (MJ) induced death in each of the cell lines. The plant hormones acted dose-dependently in the following order of sensitivity: lymphoblastic leukemia>prostate cancer>melanoma>breast cancer. Secondly, death caused by jasmonates in Molt-4 cells was determined as apoptotic, similar to the mechanism most chemotherapeutic drugs employ at the cellular level. Thirdly, jasmonates do not cause damage to normal lymphocytes. Fourthly, jasmonates are effective not only in vitro, but also in an animal model of lymphoma, significantly increasing the survival rate (by 2.25 times), using a dosage deemed safe in mice. These findings suggest that plant stress hormones may be used as a novel class of anti-cancer drugs.

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RELATED APPLICATION [0001] This application claims priority to U.S. Ser. No. 60/685,221, filed May 27, 2005, in the name of the applicant of this application. FIELD OF THE INVENTION [0002] The present invention relates generally to sexual performance aids and, more particularly and in one embodiment, to a natural sexual aid that is delivered in an edible film format. BACKGROUND OF THE INVENTION [0003] As the success of erectile dysfunction drugs VIAGRA, LEVITRA, CIALIS have shown, there is a great need for digestible supplements that enhance sexual performance. Drugs of this type are marketed to men who suffer from erectile dysfunction. They may also be consumed by men who are capable of normal sexual performance, but who are seek an enhanced sexual experience. [0004] There are a number of important limitations associated with drugs of this type. They require a prescription, they are relatively expensive, and they are non-natural. The can trigger side effects, including headaches, facial flushing, upset stomach, blurred vision, or priapism. They can interact with certain other medications, such as nitrate drugs, and therefore should not be taken by certain patients. In addition, they are delivered in pill form and must be swallowed, which can make them inconvenient for use during, or immediately proceeding, intimacy. Finally, there can be a significant delay between ingestion and response, with a delay of about 30 minutes being typical. [0005] A need exists for a consumable sexual performance aid that, in one embodiment, is natural and therefore non-prescription, and that may be readily digested in a discreet manner. The present invention satisfies these needs and provides other, related, advantages. SUMMARY OF THE INVENTION [0006] In accordance with one embodiment of the present invention, a consumable sexual performance aid is disclosed. The aid comprises, in combination: an edible strip substrate; and a sexual performance-enhancing ingredient; wherein the edible strip substrate is coated with the sexual performance-enhancing ingredient. [0007] In accordance with another embodiment of the present invention, a consumable sexual performance aid is disclosed. The aid comprises, in combination: an edible strip substrate; wherein the edible strip substrate is a breath-type strip; and a sexual performance-enhancing ingredient; wherein the edible strip substrate is coated with the sexual performance-enhancing ingredient is one of the group comprising yohimbe bark extract, Sildenafil Citrate, Vardenafil HCI, and Tadalafil. [0008] In accordance with a further embodiment of the present invention, a method for improving sexual performance is disclosed. The method comprises receiving an edible strip substrate coated with a sexual performance-enhancing ingredient; and ingesting the coated edible strip substrate. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0009] The sexual performance aid of the present invention is provided in an edible strip form. In this regard, in a first step, an edible strip substrate is provided. The edible strip may be a standard breath-type strip. A typical such strip may be comprised of hydroxypropyl methyl cellulose, artificial and natural flavor, tapioca dextrin, canola oil, menthol, maltodextrin—dietary fiber, glycerin, microcrystalline cellulose, gum arabic, acesulfame potassium, sucralose, polysorbate 80, carrageenan, citric acid, and FD&C Red 40 dye. It should be noted that an edible strip formed from some other materials or combination of materials may also be desired. [0010] In a second step, the strip substrate is coated with a composition containing one or more sexual performance-enhancing ingredients. Preferably, the composition is natural, and it may contain two or more sexual performance enhancers. [0011] In a preferred embodiment, the composition contains the following ingredients, which are thought to provide the following listed benefits: [0012] 1. Yohimbe bark extract—increases blood flow to the genital area, and may also increase the amount of Cyclic guanosine monophosphate (cGMP). cGMP is a signaling molecule within cells, which plays a role in erectile function by telling the smooth muscle in the corpora cavemosa to relax, which lets blood flow into the chambers and be trapped for an erection. [0013] A clinical study in Rhode Island tested the active ingredient in Yohimbe on a group of men who had experienced chronic sexual dysfunction. For those who had been impotent for less than two years and taking a moderate dosage over a period of one month, there was an improvement rate of 81%. Two out of three patients who had previously experienced partial erections only, and had failed in normal intercourse at least 50% of the time, reported fuller and more lasting erections, leading to consistently successful sex and lovemaking. [0014] 2. L-Citrulline—the amino acid Citrulline is a precursor to Arginine, and is involved in the formation of urea in the liver. The synthesis and elimination of urea is essential for removing toxic nitrogen metabolites from the body. Arginine is also the precursor to the polyamines such as cadaverine, putrecine, spermine, and spermidine. These polyamines help stabilize DNA. Arginine is also the precursor to creatine, which is ultimately converted to creatine. This compound is an energy buffer for muscular contraction. Arginine improves circulation, and is sometimes used in the treatment of male sexual health problems and sterility. The amino acid is sometimes used as a sexual stimulant as well. [0015] 3. Vitamin B12—also known as cyanocobalamin or cobolamin, it is a very widely researched vitamin, and is used in supplementation to a very large degree. Cobolamin is needed in the manufacture of red blood cells and the maintenance of red blood cells and it stimulates appetite, promotes growth and releases energy. It is often used with the elderly to provide an energy boost, assist in preventing mental deterioration and to speed up thought processes. It is believed by some that it assists with clearing up infections and provides protection against allergies and cancer. This vitamin is also used in the metabolism of fats, proteins and carbohydrates. [0016] 4. Cayenne Pepper—It is used as a spice and as a dietary supplement. Cayenne Pepper contains beta-carotene, beta-ionone, citric acid, hesperidin, imonen, lutein, and quercetin. It also contains capsaicin, which is thought to reduce pain and inflammation. When combined with other herbs, Cayenne Pepper has been observed to increase their effectiveness by helping them enter the blood stream faster. [0017] Preferably, the total mass of each strip, including the composition, is approximately 52 mg. Of this amount, approximately 32 to 34 mg is accounted for by the strip substrate. The remaining approximately 18-20 mg is accounted for by the composition. Each particular composition material is preferably provided in about the following amounts: Yohimbe—10 mg; L-Citrulline—6.5 mg; B-12—0.005 mg; and Cayenne Pepper—0.5 mg. [0018] It should be noted that while these mass amounts are preferred, they may be varied without departing from the spirit or scope of the present invention. [0019] It should be apparent from the foregoing that, alternatively, it would be possible to coat the strip-substrate with other sexual performance-enhancing ingredients. This may include, for example, non-natural ingredients. Examples may include erectile dysfunction medications, including Sildenafil Citrate (marketed under name VIAGRA), Vardenafil HCI (marketed under the name LEVITRA), and/or Tadalafil (marketed under the name CIALIS). [0020] While the invention has been particularly shown and described with reference to preferred embodiments thereof, it will be understood by those skilled in the art that the foregoing and other changes in form and details may be made therein without departing from the spirit and scope of the invention.

1a

CROSS REFERENCE TO RELATED APPLICATION Not Applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT Not Applicable INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC Not Applicable BACKGROUND OF THE INVENTION Field of the Invention This invention relates to improvements in a device to carrying elongated objects. More particularly, the present Sling Carrier for Skis, Snowboard and Boots creates a method to carry skis and/or snowboard with boots. The sling carrier provides full mobility for the person carrying the sporting equipment. Description of Related Art Including Information Disclosed Under 37 CFR 1.97 and 1.98 For many people that participate in outdoor winter sports, must carry their equipment from a car or ski rental location to the lift line. When a person carries the equipment to the lift the person carry the equipment and then place the equipment onto themselves for skiing or snowboarding. Most outdoor winter athletes either ski or snowboard, but some of these athletes perform both sports and must carry a large amount of equipment to the ski lift or to a place where instruction will take place. There are a number of different ways to carry ski and snowboard equipment. Without any external carrying equipment the person generally walks with the boots and carries the ski/snowboard and possibly poles. A second alternative was to have some sort of external device that allows a person to carry the ski or snowboard equipment. There are a large number of variation for carrying the equipment in one hand or on their body. A number of patents and or publications have been made to address these issues. Exemplary examples of patents and or publication that try to address this/these problem(s) are identified and discussed below. U.S. Pat. No. 5,383,587 issue to Gary L. Carpenter issued on Jan. 24, 1995 to Gary L. Carpenter discloses a Device for Carrying Elongated Ski Equipment. This patent has a pocket where the end of the skies are placed, and a strap connects from the pocket to an upper end of the skies. The strap is placed over a shoulder so the skies are slung from behind the person and under a shoulder to a position in front of the person. With this configuration the person can't bend down or forward without the skies touching the ground. The patent further does not allow the person to transport the ski boots with the skies because the ski boots will occupy an area of the person transporting the equipment. U.S. Pat. No. 6,672,495 issued on Jan. 6, 2004 discloses a Bifurcated Carrier Pack for Transporting Recreational Equipment. The patent allows the person to transport a snowboard across the back of the user. With this embodiment the person can bend over, but the orientation of the snowboard makes it difficult to move through a door, and the straps make transportation of the boots difficult. The equipment further does not allow for transportation of skies. U.S. Publication 2007/0210570 that was published on Sep. 13, 2007 for Jasper C. Erichsen discloses a Ski-Carrier. This publication is for an extendable belt mounted pocket. The pocket is secured onto a belt that holds the pants of a user. When a user wants to transport their skies they extend a pocket and slide the end of the skies into the pocket to support one end of the skies and holds the free end of the skies. Due to the orientation of the skies, the invention does not allow for transportation of the boots with the skies. U.S. Publication 2010/0206930 that was published on Aug. 19, 2010 for Andrew Jason Sims discloses a Ski and Snowboard Sling-belt. The belt slings the snowboard diagonally across the back of the user. While this patent allows for transportation of ski equipment it only allows for transportation of skies or a snowboard. After transportation the invention does not have a pocket or pouch to transport the carrier after use. What is needed is a transportation device for a skies and/or snowboard along with the poles and boots. The transportation mechanism should further provide a storage mechanism for the transportation equipment. This document provides a solution. BRIEF SUMMARY OF THE INVENTION It is an object of the sling carrier for skis, snowboard and boots to be able to carry the skies and or snowboard across the back of the wearer. The ability to sling the equipment over the back of a user allows the user to have full mobility walk. A user can tighten the sling to adjust the location of the equipment in their back. Having the equipment supported on their back allows the user to walk in a more balanced stance and the user just needs to bend forward or backward to accommodate the load or the terrain. It is an object of the sling carrier for skis, snowboard and boots to include a pocket for transportation of the skies and or snowboard. It is also a function of the carrier for the pocket to be used to store the transportation equipment and therefore allow the user to easily transport the equipment after the skies and or snowboard have been transported. It is an object of the sling carrier for skis, snowboard and boots to be used transportation of all the unique ski equipment. Along with the skies, one embodiment includes transportation of the ski poles and the boots. All of these pieces of equipment are slung over the back of the user and essentially leaves the hands free for paying for lift tickets, food or other items. It is an object of the sling carrier for skis, snowboard and boots to be used transportation of all the unique snowboard equipment. Along with the snowboard, one embodiment includes transportation of the snowboard and the boots. All of these pieces of equipment are slung over the back of the user and essentially leaves the hands free for paying for lift tickets, food or other items. It is another object of the sling carrier for skis, snowboard and boots to be used for transportation of all the unique ski equipment for a person that both skies and snowboards. Along with the skies and snowboard this embodiment includes transportation of the ski, snowboard, poles and either sets of boots. All of these pieces of equipment are slung over the back of the user and essentially leaves the hands free for paying for lift tickets, food or other items. It is still another object of the sling carrier for skis, snowboard and boots to use adjustable buckles to connect straps together. Buckles allow the user to just “squeeze” elements together to release the straps. For connecting elements together the user just pushes the parts together. This is especially important when it is cold and the user's fingers and hands are cold. This is also superior to hook-and-loop fasteners that become brittle in cold weather. Various objects, features, aspects, and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments of the invention, along with the accompanying drawings in which like numerals represent like components. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) FIG. 1 shows a sling carrier for skies with attached boots. FIG. 2 shows a view of the components used in the sling carrier for skies. FIG. 3 shows a view of the attachment of the ski poles. FIG. 4 shows the top of the skies being secured. FIG. 5 shows the bottom of the skies entering the pouch. FIG. 6 shows the top of the poles being secured to the skies. FIG. 7 shows the bottom of the poles being secured to the skies. FIG. 8 shows pouch being secured to the opposing side of the sling. FIG. 9 shows the pouch secured over a shoulder of a user. FIG. 10 shows a sling carrier with a snowboard and snowboard boots. FIG. 11 shows the components used in the sling carrier for a snowboard. FIG. 12 shows a snowboard being secured into the pouch and the sling. FIG. 13 shows the snowboard pouch being carried on the back of a user. FIG. 14 shows a sling carrier for skis, snowboard and boots. FIG. 15 shows the carrier without the ski equipment being carried as a backpack. FIG. 16 shows the components used to carry skies and a snowboard. FIG. 17 shows the snowboard in the pouch with the skies being inserted. FIG. 18 shows the top end of the poles being secured to the skies and snowboard. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows a sling carrier for skies with attached boots. In this figure the back of the user 39 is shown with the ski equipment slung over the back of the user in a diagonal orientation. In this orientation the user can bend forward and can walk with the weight of the equipment fairly evenly distributed on the user 39 . The ski boots 48 and 49 are secured in the ski bindings 47 , thereby no additional securing mechanism is required to retain the ski boots 48 and 49 . While the ski boots 48 and 49 are shown secured into the ski bindings, the user can wear the ski boots 48 and 49 as they transport the skies and ski poles slung over the back of the user. The curved end of the skies 42 and 43 are secured together with a upper ski strap 60 that both secures the skies 42 and 43 together and provides an upper connection for a front sling (not shown in this figure). The upper end of the poles 46 and 47 (obscured in this figure) are connected together with an upper pole strap 70 that is secured to a “D” ring (obscured in this figure) that is secured around the skis, in this case, skis 42 and 43 . The upper pole strap 70 is retained on the poles because the top of the ski poles include an enlarged top 44 to the hand grip portion of the pole(s). The flat under sides of the skies rest together and the bottom end of the ski poles are secured to the lower end of the skies 42 and 43 with a lower ski and pole strap 90 / 100 . The flat end of the skies 42 and 43 and secured into a pouch 80 . FIG. 2 shows a view of the components used in the sling carrier for skies. These are the components that are used to transport the skies, boots and pole. The lower ski and pole straps 90 and 100 and the pole strap 70 can be placed within the ski pouch 80 and all the components can be carried by the user as a complete unit. This will be shown and described in other figures herein. The sling strap 50 has a separable buckle 53 with a male and a female clasp that allows a user to separate the two parts, 51 and 52 , of the sling strap 50 . The separable buckle 53 further includes an adjustment mechanism to alter the overall length of the sling strap to fit the geometry of a user to adjust the location of the equipment on the back of a user. On the opposing sides of the buckle 53 there are separate lengths of straps 51 and 52 . Each of these lengths of straps terminate with operable clasps 54 and 55 . The clasps 54 and 55 , along with the buckle 53 are designed to allow an operator to connect and disconnect the components in freezing condition and with limited dexterity caused by gloves and or cold conditions. The upper ski strap 60 has a central male clasp 63 that mates or connects into a complimentary female clasp 65 . An “O” or “D” ring 64 is positioned between the male 63 and the female 65 clasps. The ring 64 allows for connection of one of the operable clasps 54 or 55 on the sling strap 50 . A free end 62 of the strap 61 allows for a user to grasp to tighten a grip on skies placed in the strap between the male 63 and the female 65 clasps. The pole strap 70 has two lengths of strap material 72 and 74 with an operable clasp 73 located at an equal distance between two separate rings 71 and 75 . In operation, a portion of the strap material, 72 or 74 is looped and passed through the respective ring 71 or 75 and the hand grip of the ski pole is passed through the loop. The loop is then tightened to secure the hand grip of the ski pole. The ski pouch 80 is essentially a pouch with an opening where the flat portion of the skies are placed to secure the flat end of the skies. The ski pouch 80 has a top flap that wraps around the opening to secure any contents within the pouch. The ski pouch 80 is shown with the lower ski strap components 90 and 100 secured to the ski pouch 80 . The lower pole strap components 90 and 100 are snapped 93 and 103 onto the ski pouch 80 . Lower pole strap component 90 has a snap 93 at a first end with a male clasp 94 and a free length of strap material 91 with a buckle 92 . A “D” ring 95 is secured to the front flap of the ski pouch 80 . The lower pole strap component 100 also snaps to the ski pouch 80 and has a female buckle 101 . FIG. 3 shows a view of the attachment of the ski poles 46 and 47 . The ski poles 46 and 47 are secured by using the pole strap 70 that has two lengths of strap material 72 and 74 with an operable clasp 73 located at an equal distance between two separate “D” ring 71 and 75 . To install the ski poles 46 and 47 onto the pole strap 70 a portion of the strap material, 72 or 74 is looped 76 and passed through the respective “D” ring 71 or 75 and the hand grip 44 or 45 of the ski pole is passed through the loop. The loop is then tightened to secure the hand grip 45 of the ski pole. FIG. 4 shows the top of the skies being secured. Because current skies 42 & 43 are parabolic in shape, the upper ski strap 60 can be secured at a narrow portion of the skies 42 & 43 . The free end 62 of the strap 60 can be pulled to tighten the strap 60 in the buckle 63 and then moved 86 up to the wider portion of the skies 42 & 43 to increase the binding of the strap 60 on the skies 42 & 43 . FIG. 5 shows the bottom of the skies 42 & 43 entering 87 into the open 88 end of the pouch 80 . A backing lip 85 extends around the back of the pocket to provide a flat surface that sits on the flat surface of the ski. The end of the skies 42 & 43 are then seated into the pocket 80 . The flap portion 85 of the pocket 80 is brought along the back side of the skies 42 & 43 . The ski pouch 80 has a number of snaps 82 , 83 and 84 for securing some of the straps, in particular the lower pole strap 90 / 100 that wraps around the pouch 80 and previously shown. FIG. 6 shows the top of the poles 46 and 47 being secured to the skies 42 . The ski poles 46 and 47 have hand grips 44 and 45 respectively where the upper pole strap 72 is secured. The clasp 73 in the center of the pole strap 72 is secured to the ring 64 on the upper ski strap 60 and then the upper pole strap 72 is brought between the curved tips of the skies for stability. The clasp 54 on the lower sling strap 52 is also connected to the ring 64 on the upper strap 60 . It is important for the ring 64 to be positioned at the side of the skies to allow the apparatus to be slung diagonally across the back of a user. FIG. 7 shows the bottom of the poles being secured to the skies. At this location the end of the ski poles 46 and 47 are shown secured to the bottom straight end of the skies 42 . The lower straps 90 / 100 secure all the skies and poles together to prevent undesirable movement while they are being transported. FIG. 8 shows pouch being secured to the opposing side of the sling strap 51 . The lower end 51 of the sling strap has a clasp 55 that connects to the “D” ring 87 on the flap 85 of the pouch 80 . The flat end of the skies 42 and 43 are shown in the pouch 80 . The snap 86 can be secured to one of the snaps 86 on the front of the pouch 80 . The ski poles 46 and 47 are shown secured to the skies 42 and 43 with the lower ski and pole strap 90 / 100 is wrapped around both the skies and both of the poles. Once both ends of the sling strap 50 have been secured with the clasp 54 in the “D” ring 64 (at the other end of strap 51 ) and the “D” ring 87 with clasp 55 of the ski pouch 80 , the user can place the sling 50 over their head and shoulder. Once the user is wearing the sling, the user can adjust the length of the sling 50 to set the preferred location of the sling on the user. To quickly remove the sling, a user can unbuckle the clasp or buckle 53 in the sling 50 . FIG. 9 shows the pouch 80 secured over a shoulder of a user 39 . When the pouch 80 is not being used to transport ski equipment, the remaining straps are placed into the pouch 80 . This view shows the clasp 53 of the sling 51 and 52 . The clasps 54 and 55 are secured to “D” ring on the back of the pouch 80 . The front flap 85 of the pouch 80 is brought over the pouch 80 where the “D” ring 87 is held by the straps. FIG. 10 shows a sling carrier with a snowboard 110 and snowboard boots 111 and 112 . The snowboard 110 , boots or boot bindings 111 and 112 are all carried on the back of the user 39 in a sling arrangement that allows the person 39 to easily walk and bend over because the equipment is distributed and balanced on the back of the user 39 . This further frees the hands of the user to pay for lift tickets or carry other items. The bottom of the snowboard 110 is held in a pocket 133 within a pouch 130 . The pouch 130 has a surrounding lip 134 with a raised front surface where the snowboard 110 fits inside of the pouch 130 . The front of the pouch 130 has some pockets with mechanical or magnetic snaps 135 and 136 for securing the pockets. A sling strap (not visible in this figure) connects from the pouch 130 to an upper strap 120 . The upper strap 120 wraps around the upper portion of the snowboard 110 to secure the snowboard 110 . The upper strap has a male 121 and a female 122 buckle portion secured on the strap 120 . The “O” ring 122 is placed in the center of the width of the snowboard. An end 123 of the strap 120 allows for tightening or loosening of the strap 120 on the snowboard 110 . FIG. 11 shows the components used in the sling carrier for a snowboard. The sling strap 50 has a separable buckle 53 with a male and a female clasp that allows a user to separate the two parts, 51 and 52 , of the sling strap 50 . The separable buckle 53 further includes an adjustment mechanism to alter the overall length of the sling strap to fit the geometry of a user to adjust the location of the equipment on the back of a user. An adjustable pad 56 is present on the strap 52 to provide a cushion and to distribute loads on the strap 50 . On the opposing sides of the buckle 53 there are separate lengths of straps 51 and 52 . Each of these lengths of straps terminate with operable clasps 54 and 55 . The clasps 54 and 55 , along with the buckle 53 are designed to allow an operator to connect and disconnect the components in freezing condition and with limited dexterity caused by gloves and or cold conditions. The pouch 130 is configured with a square or rounded bottom to accept either end of a snowboard. The pouch 130 has a front flap 132 that closes over a pocket opening 133 where an end of a snowboard is secured therein. The flap has a “D” ring at the front of the flap for securing one end 55 of the sling strap 50 . Mechanical or magnetic snaps 137 and 138 secure the flap 132 to the front of the pouch 130 . A plurality of “D” rings and clasps 127 , 128 and 129 are located on the front and back of the pouch 130 for converting the pouch into a backpack for storage of the straps and or other personal items. An upper snowboard strap 120 is configured to wrap around the snowboard. The inside of the upper snowboard strap 120 is reinforced or backed with leather or other equivalent material to protect the strap material from being damaged from the hard sharp edges of the snowboard. This strap 120 has a male connector 121 and a female connector 125 at opposing ends. The tail 123 can be pulled to tighten the strap 120 on the snowboard. Between the male 121 and the female 125 connectors an “O” ring is located between the strap portions 122 and 124 . The “O” ring is used to connect to the other clasp 55 on the opposing end of the sling strap 50 . Two additional strap members 140 are used to transport the pouch 130 as a backpack. The strap members 140 are essentially the same. The straps 140 include clasps 141 and 147 on each end of the strap. The strap 140 has three section 142 , 144 and 146 . Between section 144 and 146 a “D” ring 145 is located for securing the end of the strap 144 . An adjustable buckle 143 is located to adjust the overall length of the strap 140 . FIG. 12 shows a snowboard being secured into the pouch and the sling. First the upper strap is secured around the snowboard 110 and then buckle at the end of strap portions 122 and 124 is connected. The strap is tightened onto the snowboard 110 at a position above the top boot binding. When the top strap is attached, the “O” ring 123 is centered in the middle of the base width wise. Snowboards also have a parabolic shape. The method for attaching the top strap 122 is to clip it around the board just above the leading (top) binding, pull the adjuster strap down nice and snug making sure the “O” 123 is centered on the base, the strap is moved up until the strap reaches the widest part of the parabolic shape making a nice and tight strap on the snowboard. The bottom of the snowboard is slid into the pouch opening 139 to a position below the lower binding 111 . The top flap 132 is lifted to allow the clip 55 of the sling strap to connect to the “D” loop 126 . The other end of the sling strap 52 is then hooked 54 into the “O” ring 123 of the upper strap. The user can then enter into the sling strap and tighten the sling strap for the desired fit. When the board is being transported, the top strap will come into contact with the edges as it is positioned on the base. Those edges can be extremely sharp and would probably cut right through a standard nylon strap. As with the ski sling, the central buckle on the sling strap is disconnected to quickly exit from the snowboard sling carrier. FIG. 13 shows the snowboard pouch being carried on the back of a user. When the snowboard carrier is not being used to transport the snowboard the pouch 130 can be used as a backpack. The strap members 142 are connected to the “D” ring 129 at the top of the carrier and also connected to “D” rings 158 (obscured in this view) on the back of the carrier 130 . The straps 140 can then be adjusted to the desired fit based upon the desires of the user or the physical features of the user 39 . FIG. 14 shows a sling carrier for skis, snowboard and boots. In this embodiment a user 39 is able to carry all of the ski and snowboard equipment with a single sling carrier. The hands of the user remain free. The majority of the components have been shown and described in previous embodiments shown and described herein with the exception of the pouch 150 . The pouch has two pockets, a first pocket 151 where the snowboard 110 is inserted and a second pouch 153 where the flat ends of the skies are inserted, and the ends of the ski poles 46 and 47 are retained. The pocket 153 for the skies 42 & 43 essentially folds out perpendicular to the pocket 51 that retains the snowboard 110 . A flap 152 covers the ski retaining pocket 153 when the pocket is not being used. FIG. 15 shows the carrier without the ski and snowboard equipment being carried as a backpack. This figure shows the other side of the flap 152 with storage pockets 154 and 155 for storage of the securing straps. The back of the flap 152 further includes a transparent window 156 for storage of a license, lift ticket etc. When the carrier 150 is not being used to transport the skies and or snowboard the pouch 150 can be used as a backpack. The strap members 142 are connected to the “D” ring 157 at the top of the carrier and also connected to “D” rings (obscured in this view) on the back of the carrier 150 . The straps can then be adjusted to the desired fit based upon the desires of the user or the physical features of the user 39 . FIG. 16 shows the components used to carry skies and a snowboard. The straps 50 , 70 , 120 , 140 and 190 are essentially the same as previously described. Strap 50 includes a protective sleeve 57 to reduce abrasion of the clasp 54 . Strap 190 is essentially the same as strap 120 with a slight difference in the length of the strap and strap 120 further has an additional clip that is adjacent to the female part of the buckle. The clip is secured to the upper ski strap 190 . To assemble the skis within this storage version the curved ends of the skies are bound as previously described and the grip ends of the ski poles are bound as previously identified. FIG. 17 shows the snowboard in the pouch with the skies being inserted. The strap 120 is secured to the snowboard 110 as previously described. The snowboard 110 is inserted into the pocket 151 of the pouch 150 . An inner pocket 153 is exposed from the pouch 150 and the flat end of the skies are inserted into the inner pocket 153 . The skies 42 and 43 are elevated, essentially parallel to the snowboard 110 . FIG. 18 shows the top end of the poles being secured to the skies 42 & 43 and snowboard 110 . In this figure the strap 70 that retains the ski poles 46 & 47 are secured to the “D” ring of strap 190 . The “D” ring of strap 190 is connected to clip that is adjacent to the female buckle. The free end of the ski poles are the tucked into the pocket 153 . The sling strap 50 is secured to strap 120 and to the pouch 150 to allow a user to lift all the equipment onto their back for transportation. While specific materials of leather, nylon and “O” rings and buckles have been identified in the application, it should be obvious to one skilled in the art that future progression of the carriers can include alternative materials and construction that provide the same or superior functionality. Thus, specific embodiments of a sling carrier for skis, snowboard and boots has been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims.

1a

FIELD OF THE INVENTION The present invention relates to a pharmaceutical composition for relieving ocular allergies. More particularly, the present invention relates to ophthalmic compositions comprising ethyl 4-(8-chloro-5,6-dihydro-11-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate, otherwise known as loratadine. BACKGROUND OF THE INVENTION Allergic conjunctivitis is an ocular allergy characterized by redness, itching and swelling of the eyes. Allergic conjunctivitis is a similar reaction to allergies of the sinuses, nose, or lungs, in that it is characterized by the release of histamines from contact with allergens such as pollen, pet hair or dander, or dust. H 1 histamine receptor antagonists are used widely in the systemic treatment of allergies, and have recently been shown to be effective when used topically on the eye. (Doughty, The Pharmaceutical Journal, 268, 367-370, Mar. 16, 2002). Two H 1 histamine receptors, emedastine and levocabastine, are currently available in eye drop formulations for treatment of allergic conjunctivitis and related conditions. Another H 1 histamine receptor, Loratadine, sold by Schering-Plough under the brand name Claritin®, is used widely in the oral dosages forms of tablets and syrup for the systemic treatment of allergies. However, no topical ophthalmic product containing loratadine is currently available due to its insolubility and instability in aqueous solutions. The low water solubility of loratadine results in poor delivery of the drug topically, resulting in limited ocular activity. For water insoluble active agents such as loratadine, ophthalmic formulations typically comprise a suspension or a solution containing solubilizers such as surfactants, cosolvents and complexing agents to enhance the solubility of the compound. The manufacturer of Claritin®, Schering-Plough, has experimentally prepared an ophthalmic formulation of loratadine using Tween-80®, a surfactant, as a solubilizer. (WO9715307) This formulation required at least 2.3% Tween-80® to solubilize 0.05% loratadine in solution. However, the relatively high concentration of surfactant increases eye irritation, which is counterproductive in a product intended to reduce ocular discomfort and irritation. Claritin® syrup is formulated at pH 2.5-3.1, at which pH loratadine is more soluble. However, this acidic pH is not suitable for ophthalmic liquids. In addition to being less soluble at the desirable ophthalmic pH range of 6-8, loratadine is also chemically unstable at this pH range. The cleavage of the ester linkage leads to the formation of the corresponding acid and ethyl alcohol much more readily in neutral or basic aqueous solutions. Schering-Plough also formulated eye drops containing loratadine metabolites or derivatives that had some improved properties (WO 9848803). However, despite these efforts, no topical ophthalmic product containing loratadine as the active ingredient is currently available, although the patent for loratadine (U.S. Pat. No. 4,282,233) issued in 1981. Given the importance of loratadine in treating systemic allergies, one skilled in the art would expect that a topical ophthalmic product containing loratadine would also make a significant contribution to the treatment of ocular allergies. The lack of an available topical ophthalmic product containing loratadine therefore shows that difficulties in formulating loratadine have not been overcome, and that a need still exists to formulate the compound into effective topical ophthalmic product. SUMMARY OF THE INVENTION DETAILED DESCRIPTION OF THE INVENTION Unexpectedly, we have found that the difficulties experienced by others in formulating loratadine are overcome by the present invention, which delivers loratadine in an aqueous ophthalmic emulsion composition. In the present invention, the loratadine is dissolved in the oil phase of an oil-in-water emulsion system. This confers three main advantages to this invention over previous topical ophthalmic loratadine products. These advantages are higher drug absorption, minimal decomposition of loratadine by hydrolysis, and lubrication and improved comfort to the eye. We have found that the solubility of loratadine in vegetable oils is great enough to formulate an effective amount of the agent into an ophthalmic emulsion formulation (see Table 1) to be used for allergic conjunctivitis and TABLE 1 Solubility of Loratadine in Vegetable Oils Oil Solubility (mg/mL) Castor Oil 85 Corn Oil 25 Miglyol 810N 15 Peanut Oil 15 Sesame Oil 15 Soybean Oil 15 Polysorbate 80 (Nonionic surfactant) 25 related conditions. The solubility of loratadine in vegetable oils is comparable to or better than its solubility in a surfactant. In particular, castor oil dissolves more than three times as much loratadine as Polysorbate 80, a commonly used surfactant in ophthalmic solutions. By contrast to the irritation to the eye caused by the surfactant alone, it has been shown in commonly assigned U.S. Pat. No. 5,668,133, incorporated herein by reference, that an emulsion actually provides lubrication and improved comfort to the eye. It has also been shown, in European Patent No. 1044678, that an emulsion of vegetable oil and water delivers a higher concentration of the drug cyclosporin A to the conjunctiva of a rabbit eye than the individual oil. Additionally, dissolving the hydrophobic loratadine in the oil phase of an emulsion significantly reduces the contact of the hydrophobic loratadine with water, enabling a formulation to be prepared in the ophthalmically useful pH range of 6-8. This is in contrast with aqueous solutions where the loratadine is readily hydrolyzed in the desired ophthalmic pH range, greatly reducing the activity and the shelf life of the product. The present invention is directed to an ophthalmic formulation which comprises a therapeutically effective amount of loratadine, a fatty acid ester, and a surfactant. In the preferred embodiment of this invention, the fatty acid ester is a vegetable oil. A fatty acid ester has the meaning commonly understood in the art, being an ester formed between an alcohol and a fatty acid. While not intending to limit the scope of this invention, some examples of readily available fatty acid esters are triglyceride esters commonly known as vegetable oils, mono and diglyceride esters of fatty acids, and fatty acid methyl esters. The fatty acid ester may be a mixture of several chemical compounds or an essentially pure compound. Preferably, the fatty acid ester is a vegetable oil. Examples of vegetable oils include castor oil, sesame oil, soybean oil, cottonseed oil, olive oil, peanut oil, safflower oil, sunflower oil, palm oil, palm kernel oil, canola oil, and Miglyol oil. Most preferably, the fatty acid ester is castor oil. The determination of a therapeutically effective amount of loratadine used in this formulation can be readily determined by one skilled in the art. Preferably, the concentration of loratadine is between about 0.01% and about 1.5%. More preferably, the concentration of loratadine is about 0.0125% or about 0.0625%. The term surfactant used in this invention has the meaning commonly understood in the art. Surfactants are used to both help facilitate the formation of the emulsion and improve its stability. Anionic, cationic, amphoteric, zwitterionic, and nonionic surfactants may all be used in this invention. Preferably, a nonionic surfactant is used in this invention. While not intending to limit the scope of the invention, some examples of useful nonionic surfactants are polysorbates, poloxamers, alcohol ethoxylates, ethylene glycol-propylene glycol block copolymers, fatty acid amides, alkylphenol ethoxylates, and phospholipids. Most preferably, Polysorbate 80 is used as the surfactant. Polysorbate 80 is a mixture of oleate esters of sorbitol and sorbitol anhydrides, consisting predominantly of the monoester, condensed with approximately 20 moles of ethylene oxide. It conforms generally to the formula: where w+x+y+z has an average value of 20. Polysorbate 80 is available from ICI Americas, Inc., Wilmington, Del. In another preferred embodiment of this invention, an emulsion stabilizing polymer is used. While not intending to limit the scope of the invention, emulsion stabilizing polymers generally contain hydrophilic groups such as cellulose, sugars, ethylene oxide, hydroxide, carboxylic acids or other polyelectrolytes. While not wishing to limit the scope of the invention by theory, it is believed that these polymers help to stabilize emulsions by increasing the viscosity of the formulation as well as by reducing the interfacial tension. While not intending to limit the scope of the invention, some examples of emulsion stabilizing polymers useful in this invention are carbomers, Pemulen®, sodium carboxymethylcellulose, hydroxypropylmethylcellulose, povidone, polyvinyl alcohol, and polyethylene glycol. In the most preferred embodiment of this invention, Pemulen® is used as the polymeric based stabilizer. Pemulen® is a registered trademark of B.F. Goodrich for polymeric emulsifiers and commercially available from B.F. Goodrich Company, Specialty Polymers & Chemicals Division, Cleveland, Ohio. Pemulens® are Acrylates/C10-30 Alkyl Acrylate Cross-Polymers. They are high molecular weight co-polymers of acrylic acid and a long chain alkyl methacrylate cross-linked with allyl ethers of pentaerythritol. They contain not less than 52.0 percent and not more than 62.0 percent of carboxylic acid groups. The viscosity of a neutralized 1.0 percent aqueous dispersion is between 9,500 and 26,500 centipoises. In the preferred embodiment of this invention the weight ratio of castor oil to Polysorbate 80 is from about 0.3 to about 30. In a more preferred embodiment of this invention, the weight ratio is from about 0.5 to about 12.5. In another preferred embodiment of this invention, a buffering agent is used to maintain the pH in the therapeutically useful range of about 6-8. Buffering agents used are those known to those skilled in the art, and, while not intending to be limiting, some examples are acetate, borate, carbonate, citrate, and phosphate buffers. In the most preferred embodiment of this invention, boric acid is the buffering agent. In another preferred embodiment of this invention, a tonicity agent is used to adjust the composition of the formulation to the desired isotonic range. Tonicity agents are known to those skilled in the ophthalmic art, and, while not intending to be limiting, some examples include glycerin, mannitol, sorbitol, sodium chloride, and other electrolytes. In the most preferred embodiment of this invention, the tonicity agent is glycerin. In another preferred embodiment of this invention, a preservative is used. Preservatives are used to prevent bacterial contamination in multiple-use ophthalmic preparations, and, while not intending to be limiting, examples include benzalkonium chloride, stabilized oxychloro complexes (otherwise known as Purite®), phenylmercuric acetate, chlorobutanol, benzyl alcohol, parabens, and thimerosal. In the most preferred embodiment of this invention, the preservative is Purite®. In another preferred embodiment of this invention, a chelating agent is used to enhance preservative effectiveness. Suitable chelating agents are those known in the art, and, while not intending to be limiting, edetate salts like edetate disodium, edetate calcium disodium, edetate sodium, edetate trisodium, and edetate dipotassium are examples of useful preservatives. The best mode of making and using the present invention are described in the following examples. These examples are given only to provide direction and guidance in how to make and use the invention, and are not intended to limit the scope of the invention in any way. FORMULATION EXAMPLES Ophthalmic Formulations 1 and 2 containing loratadine were formulated with the compositions shown in Table 2. Emulsions were prepared according to the method described in U.S. Pat. No. 5,981,607, incorporated herein by reference, with the loratadine being added to the castor oil before introducing the oil into the emulsion. TABLE 2 Example Loratadine Emulsion Formulations Amount, % w/w Ingredient Placebo Formulation 1 Formulation 2 Loratadine 0 0.0125 0.0625 Castor Oil 1.25 1.25 1.25 Polysorbate 80 1.0 1.0 1.0 Pemulen ® 0.1 0.1 0.1 Glycerin 1.0 1.0 1.0 Boric Acid 0.6 0.6 0.6 Purite ® 0.0075 0.0075 0.0075 Purified Water qs. ad. 100 qs. ad. 100 qs. ad. 100 The physical stability of the example loratadine emulsion formulations was monitored and the results are provided in Table 3. The emulsions were allowed to stand for 5.5 months at 20-25° C., and the emulsion droplet sizes were measured. The emulsion droplet sizes within experimental error, were identical at 5.5 months to those measured right after the emulsions were prepared, suggesting that there was no significant coalescence of the emulsion droplets. Additionally, no creaming of the formulations or precipitation of solid loratadine was observed. These results demonstrate that the emulsions prepared in these formulations have superior physical stability. TABLE 3 Physical Stability and Droplet Size of Loratadine Formulations Timepoint Test Parameter Placebo Formulation 1 Formulation 2 0 Mean Droplet 0.163 0.114 0.0987 Size (micron) Mean Droplet 0.121 0.111 0.0935 Size (micron) Creaming none none none 5.5 Mean Droplet not 0.115 0.100 months Size (micron) measured Mean Droplet not 0.112 0.0965 Size (micron) measured Creaming none none none TREATMENT EXAMPLE Several drops of Formulations 1 are administered to the eyes of a patient suffering from allergic conjunctivitis. Reduction of the symptoms becomes noticeable within one hour. The treatment is repeated one or more times daily while the condition persists.

1a

[0001] This application claims priority to U.S. Provisional Patent Application No. 62/265,439, filed on Dec. 10, 2015. The entirety of the aforementioned application is incorporated herein by reference. The present disclosure relates to the field of orthopedic implements, and, more particularly, to a top-loading pedicle screw assembly adapted to be screwed into two or more vertebral pedicles for affixing a rod or other joining implement to the vertebral pedicles. TECHNICAL FIELD Background [0002] Pedicle screw assemblies are well known devices and are often used to fasten an orthopedic implement, such as a solid bar, to two or more vertebrae to hold the vertebrae into a desired orientation. [0003] A common design for a pedicle screw system is to have a screw shank top that is shaped as a spherical top and there is a head or socket that is attached to the spherical screw shank top to move poly-axially therewith. As such, the screw shank top is normally spherical with the head fitting over that spherical shaped shank top to allow movement there between. [0004] One problem, however, with such a design is that the rod that extends between two or more pedicle screw systems is displaced away from the spinal column whereas it would be preferable for the rod to be positioned as close to the spinal column as possible. In addition, with the prior art systems, there are insertional complications since the threaded shank portion can become misaligned during the insertion process. For example, the threaded shank portion may become misaligned from the head which is held by instrumentation during the insertion process. [0005] Accordingly, it would be advantageous to have a specially designed pedicle screw assembly where the rod joining two or more pedicle screw systems can be positioned close to the spinal column and also a system that can be readily installed to the spinal column in a positive and stable alignment manner. It would be further advantageous to have a pedicle screw assembly having the ability to allow poly-axial motion while having a direct connection to the alignment features that are necessary for screw insertion into the spinal column. BRIEF SUMMARY OF THE DISCLOSURE [0006] The present disclosure therefore, improves upon the features of the existing pedicle screw systems and includes a screw having a distal end with a threaded shaft and a proximal screw shank top that forms a socket for a head that is interfitted into that socket. As such, the insertion cannot become misaligned since the screw shank, which is held for alignment during insertion, is integral with the threaded shaft and, therefore, there is no movement between the screw shank top and the threaded shaft of the screw, yet the poly-axial motion is maintained. In addition, with the present disclosure, the location of the rod, as finally installed, is positioned closer to the spinal column than with the prior art systems. In addition, the present disclosure positions the rod at the center of, or close to the center of, the socket head interface. [0007] As such, with the present disclosure, the distal or threaded end of the threaded shaft is pointed and is screwed into the vertebral pedicle. The proximal end is integral with the threaded shaft and can easily be manipulated to carry out the screwing of the screw into the vertebral pedicle. In one aspect, the screw shank top has two flat outer surfaces to facilitate the grasping and rotating of the screw in order to screw it into the vertebral pedicle of the patient. [0008] The interior surface of the shank top of the screw is a specially formed curved surface, such as a spherical configuration, to form a socket that receives the head that interfits into the interior socket of the shank top of the screw. The head has a lateral through bore to position and hold the rod as it passes through the head. The shape of the head is such as to conform to the interior surface of the shank top of the screw to allow the poly-axial movement between the head and the screw shank top. In one aspect, the exterior surface of the head and the interior surface of the shank top of the screw are both spherical. [0009] A locking element is introduced into the head so as to lock the head within the socket of the screw shank top. In one aspect, the locking element can be a set screw that is introduced into the head to expand the exterior surface of the head to firmly lock that head to the shank top of the screw so as to lock the rod in its desired position interconnecting to two or more vertebral pedicles. [0010] Other features of the present pedicle screw assembly will become more apparent in light of the following detailed description and as illustrated in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 is a side view, partly in cross section, illustrating the pedicle screw assembly, according to one aspect of this disclosure. [0012] FIG. 2 is a front view of the pedicle screw assembly of FIG. 1 , according to one aspect of this disclosure. [0013] FIG. 2A is a side cross sectional view of the pedicle screw assembly of FIG. 1 taken along the line 2 A- 2 A of FIG. 2 , according to one aspect of this disclosure. [0014] FIG. 3 is as top view of the pedicle screw assembly of FIG. 1 , according to one aspect of this disclosure. [0015] FIG. 4 is a perspective view of the pedicle screw assembly of FIG. 1 , according to one aspect of this disclosure [0016] FIG. 5 shows a method for inserting the pedicle screw assembly into a vertebrae, according to one aspect of this disclosure. [0017] FIG. 6 shows a perspective view of two consecutive vertebrae and two pedicle screw assemblies, according to one aspect of this disclosure. [0018] FIG. 7A shows another design of the head, according to one aspect of this disclosure. [0019] FIG. 7B shows a side view of the head 70 , according to one aspect of this disclosure. [0020] FIG. 7C shows a cross-sectional view of the head 70 taken along the A-A line in FIG. 7B , according to one aspect of this disclosure. DETAILED DESCRIPTION [0021] In FIG. 1 , there is shown a side view illustrating the pedicle screw system 10 of the present disclosure. As can be seen in FIG. 1 , the pedicle screw system 10 comprises a screw 12 having a threaded shaft 14 ending in a pointed distal end 16 that is adapted to be screwed into a pedicle of a patient's spine. The screw 12 is preferably made of titanium; however, other materials could be used, such as stainless steel or cobalt chrome. Alternatively, the screw 12 can be made by powder metallurgy methods using powder that is sintered to form the finished form. In such case, the material may be stainless steel. [0022] At the proximal end 18 of the screw 12 , there is a shank top 20 that is specially designed in accordance with the present disclosure. As can be seen, the shank top 20 has an interior socket 22 forming by its interior spherically shaped surface and an exterior surface 24 having oppositely disposed flat surfaces 26 to enable the physician to use a tool to grasp the shank top 20 to screw the screw 12 into the vertebral pedicle of the patient. The flat surfaces 26 are shown in FIG. 1 in one location, however, it may be seen that the flat surfaces 26 may be moved 90 degrees or at some intermediate offset. [0023] There are lateral openings 28 (only one is shown in FIG. 1 ) that pass through the shank top 20 and are provided to make space for the addition of a rod 30 that passes through the lateral openings 28 so that the rod can be poly-axially affixed to the pedicle screw assembly 10 and connect the pedicle screw assembly 10 in FIG. 1 to at least another, adjacent pedicle screw assembly in creating some stability to the spinal column of the patient. In one aspect, the rod 30 may inserted into a through bore 40 (discussed in more detail below). In one aspect, the rod 30 may be lowered into the through bore 40 by passing the rod 30 through the threaded bore 42 (discussed in more detail below). Therefore, in one aspect of this disclosure, the pedicle screw system 10 may be a top-loaded pedicle screw. [0024] Interfitted into the shank top 20 is a head 32 that is comprised of a main body 34 that is generally arcuate and has an outer flange 36 . As can be seen, the outer surface 38 (shown in FIG. 4 ) of the main body 34 is shaped to be compatible with the interior surface 22 of the shank top 20 so that the head 32 can move with a poly-axial motion with respect to the shank top 20 and, correspondingly, to the screw 12 . This is one aspect in which this disclosure differs from what is taught in the prior art. As discussed above, prior art systems have a screw that rotates about the shank top. However, in this aspect of this disclosure, the shank top 20 and the screw 12 are in a fixed relationship. Rather, it is the interfitted head 32 that enables poly-axial motion. Again, the head 32 , like the screw 12 , can be a sintered material such as cobalt/chrome. [0025] In one aspect as illustrated in the figures, the outer surface 38 of the main body 34 is spherical as is the interior surface of the shank top 20 so as to accommodate the poly-axial movement. One of ordinary skill in the art would readily recognize that shapes other than spherical may be used to accommodate the poly-axial movement. [0026] The head 32 has the through bore 40 to allow the rod 30 to pass therethrough for the purpose previously described. The through bore 40 is oriented about normal to the main longitudinal axis of the screw 12 . Head 32 also includes a threaded bore 42 having a main axis generally parallel to or even coaxial with the main longitudinal axis of the screw 12 . The threaded bore 42 includes threads 44 leading up to the outer flange 36 . In one aspect of this disclosure, the threads 44 may be dovetail threaded. When the threads 44 are dovetail threaded, it may mate with a locking element (described in more detail below) which may also be dovetail threaded. [0027] A locking element is thus used to lock the rod 30 to the head 32 such that the rod 30 moves along with the head 32 as the latter is poly-axially moved with respect to the shank top 20 . In one aspect of the present disclosure, the locking element is a set screw 46 (shown in FIG. 4 ) having threads 48 that mesh with the threaded bore 42 so that the set screw 46 can be screwed into the threaded bore 42 . While a set screw 46 is certainly feasible as the locking element, it can be seen that other devices can be used in place of the set screw to lock the rod 30 to the head 32 . As alluded to above, in one aspect of this disclosure, the locking element may be dovetail threaded. When the locking element is dovetail threaded, it may mate with a dovetail threaded thread 44 . [0028] The pedicle screw system 10 may include a base 13 . In one aspect, the base 13 may have four flat surfaces such that a cross-section of the base 13 may be rectangular. In another aspect, the base 13 may be cylindrical such that the cross-section of the base 13 may be circular. One of ordinary skill in the art would readily recognize that other shapes of the base 13 may be used. [0029] Turning now to FIG. 2 , there is shown a front view of the pedicle screw system 10 of the present disclosure. FIG. 2 illustrates one of the flat surfaces 26 of the shank top 20 that facilitate the function of screwing the screw 12 into the vertebral pedicle of a patient and, again the flat surfaces 26 are oriented in one position in FIG. 2 ; however, it can be seen that the flat surfaces may be in other orientations while maintaining their separation at 180 degrees. [0030] FIG. 2A is a cross-sectional view of the present pedicle screw system 10 taken along the line 2 A- 2 A of FIG. 2 and illustrates an optional feature of the present disclosure. That optional feature is a clip 50 that can be positioned within the interior of the head 32 . The clip 50 can be a relatively flexible member that allows the physician to simply snap the rod 30 into the head 32 to temporarily hold the rod 30 in position while other activities are being conducted during the surgery. [0031] In one aspect as illustrated in FIG. 2A , the clip 50 can be seen to be U-shaped with a pair of ends 52 facing the set screw 46 forming an opening 54 . As such the insertion of the rod 30 (shown in FIG. 1 ) flexes the ends 52 outwardly so that the rod 30 passes through the opening 54 in a snap-in manner to seat the rod 30 within the head 32 . Accordingly, the presence of the clip 50 is a convenience to the physician in carrying out the overall operation. The clip 50 may be designed so it also contacts the inner surface of the shank top 20 (shown spherically), thus causing a friction contact when the set screw 46 engages the rod 30 . In one aspect of this disclosure, an outer edge of the clip 50 may have a shape similar to gear teeth around the edge of the clip 50 . In this aspect, the gear teeth may be in contact with the shank top 20 . [0032] Turning then to FIG. 3 , there is shown a top view of the pedicle screw system 10 of the present disclosure and illustrating, again, the flat surfaces 26 along with the upper surface of the set screw 46 with an indentation 54 that is shaped to receive a tool manipulated by a physician to screw the set screw 46 into the head 32 . [0033] Turning to FIG. 4 , taken along with FIG. 1 , there is a perspective view of the pedicle screw system 10 of the present disclosure and, as can be seen, the set screw 46 has been screwed into the head 32 . The progress of the set screw 46 and its insertion into the head 32 may serve two purposes. First, the insertion of the set screw 46 forcefully presses against the rod 30 to stabilize and hold the rod 30 firmly affixed to the head 32 and secondly, the insertion of the set screw 46 serves to expand the threaded bore 42 to, in turn, expand the outer surface 38 of the main body 34 of the head 32 so that the outer surface 38 forcefully engages the interior socket 22 of the shank top 20 , thus locking the head 32 into position within the shank top 20 . In addition, the force drives the rod 30 into the clip 50 , if present, causing additional locking between the head 32 and the shank top 20 . [0034] Accordingly, the dimensions of the set screw 46 and threaded bore 42 are predetermined so that the expansion of the main body 34 by the insertion of the set screw 46 into that threaded bore 42 is sufficient to engage and lock the head 32 within the shank top 20 . [0035] As such, the pedicle screw of the present disclosure is modular, that is, the head is readily and easily disconnected from the socket without damage to any of the components. As such, the connection is permanent enough to perform surgical expectations but simple enough to take apart wherein the pieces or components could be interchanged in the operating room. The head 32 cannot be disconnected with the rod 30 in place. [0036] FIG. 5 shows a method 500 for inserting the pedicle screw 10 into a vertebrae, according to one aspect of this disclosure. The method 500 may begin at block 502 . At block 502 , the pedicle screw 10 may be inserted into a desired vertebrae pedicle. For example, the desired vertebrae pedicle may be a vertebrae pedicle needing to be aligned. After block 502 is completed, the method 500 may proceed to block 504 . [0037] At block 504 , the rod 30 may be loaded into the through bore 40 of the pedicle screw 10 . The rod 30 may be inserted in any suitable manner. For example, in one aspect of this disclosure, the rod 30 may be top loaded into the pedicle screw 10 . In this aspect, the rod 30 may be lowered into the through bore through the threaded bore 42 . In another aspect, the rod 30 may be inserted directly into the through bore, skipping the open channel. After block 504 is completed, the method 500 may proceed to block 506 . [0038] At block 506 , the pedicle screw 10 may be adjusted to properly accept the rod 30 . For example, the curvature of the rod 30 may require that the head of the pedicle screw 10 be oriented in a certain manner to properly align the spine. One of ordinary skill in the art would readily recognize that other adjustments may be needed to properly accept the rod 30 to align the spine. After block 506 is complete, the method 500 may proceed to block 508 . [0039] At block 508 , the rod 30 may be locked to the pedicle screw 10 . For example, the set screw 46 may be inserted into the threaded bore 42 . The set screw 46 may apply a downward force to the rod 30 , which in turn may apply an outward force to the head 32 . The head 32 may then press against the shank top 20 , locking the head 32 in place. After block 508 is completed, the method 500 may end. [0040] One of ordinary skill in the art would readily recognize that method 500 may be used with any number of pedicle screws 10 . For example, a plurality of screws may be used to hold the 30 to properly align the spine. [0041] FIG. 6 shows a perspective view 60 of two consecutive vertebrae and two pedicle screw assemblies 10 , according to one aspect of this disclosure. As shown in FIG. 6 , each of the vertebrae has a pedicle screw assembly 10 coupled to it. After each pedicle screw 10 is coupled to the respective vertebrae, the rod 30 may be inserted into the head 32 for each pedicle screw assembly 10 . The rod 30 may be inserted into the heads by lowering the rod through the opening. The rod 30 may serve to align the vertebrae. After the rod 30 has been inserted into the heads 32 , a locking element may be inserted into the threaded bore 42 , which may lock both pedicle screw assemblies 10 . [0042] FIG. 7A shows another design of a head 70 , according to one aspect of this disclosure. In this aspect, the head 70 may include at least one angled surface 72 . In one aspect of this disclosure, the head 70 may include two angled surfaces 72 facing the through bore 40 . The head 70 may also include a slot 74 . The slot 74 may be formed in the inner surface of the head 70 . Therefore, when the set screw 46 , for example, is tightened, the set screw 46 not only spreads the outer surface 38 of the head 70 , via the rod 30 , to lock it, but the slot 74 may spread even further to assist in the locking. In this aspect, the head 70 may not include a clip 50 . [0043] FIG. 7B shows a side view of the head 70 , according to one aspect of this disclosure. As shown in FIG. 7A , the slot 74 is center aligned in the head 70 . One of ordinary skill in the art would readily recognize that the slot 74 may be located in other positions in the head 70 . [0044] FIG. 7C shows a cross-sectional view of the head 70 taken along the A-A line in FIG. 7B , according to one aspect of this disclosure. This cross-sectional view of the head 70 shows two angled surfaces 72 . In this aspect, the two angled surfaces 72 are opposite each other. However, one of ordinary skill in the art would readily recognize that other relative positions of the two angled surfaces 72 may be possible. Additionally, one of ordinary skill in the art would also recognize that any number of angled surfaces 72 may be used. [0045] While the present disclosure has been set forth in terms of a specific aspect or aspects, it will be understood that the pedicle screw assembly herein disclosed may be modified or altered by those skilled in the art to other configurations. Accordingly, the disclosure is to be broadly construed and limited only by the scope and spirit of the claims appended hereto.

1a

FIELD OF THE INVENTION [0001] The present invention relates generally to cooking utensils and in particular to a press for making patties, and to a method of forming patties from food product such as hamburger patties. BACKGROUND OF THE INVENTION [0002] One of the problems associated with prior art food presses has been the non-uniformity of the final pressed product. Uniformity is important not only in connection with the quantity of food material to be incorporated into the patty, but also in relation to its shape and appearance. [0003] Many food presses for forming patties have been considered. For example, U.S. Pat. No. 4,180,889 to Joffe discloses a mould for forming hamburger patties having an integral plastic flat top and sidewalls defining a cavity. The walls are notched at opposed locations, and the top has a U-shaped slot with its ends on a line between the points. The top is of reduced thickness between the slot ends and notches to form hinges. Unfortunately, this design suffers from the inability to form patties of uniform size, and is without the capacity to remove excess meat during patty formation. [0004] U.S. Pat. No. 5,112,634 to Swearingen discloses a mould for forming ground meat into patties. The mould has a hollow, cylindrical collar, which may be placed on a surface, and a centre plug with a first end fitting closely into the collar. The first end is concave and has a plurality of outwardly extending dimples. The plug is inserted into the collar and pressed. Similar to the Joffe mould, this design also suffers from an inability to form patties of uniform size, and is without the capacity to remove excess meat during patty formation. [0005] U.S. Pat. No. 4,106,162 to Fournier discloses a mould for forming patties comprising an annular flat lower disc and an upper annular disc. The upper disc is of a smaller diameter than the lower disc and has a depending wall. A hollow member extends from the centre of one disc while a complementary telescoping solid element extends from the centre of the other disc. When the two elements are in engagement, the discs are guided toward each other by the co-operating elements to form a patty with a central opening. Generally, the buying public objects to burger patties with missing portions and as a result this mould suffers disadvantages. [0006] U.S. Pat. No. 3,943,602 to Siclari discloses a patty-making apparatus comprising an upper chamber for holding a food mix, and a lower chamber for holding stacked patty moulds. The chambers are separated by a partition having an opening therein so that food mix can pass from the upper chamber and into patty moulds in the lower chamber. The lower chamber is closed at the bottom in a resilient manner. Aside from being complex and thus expensive, the Siclari apparatus does not produce satisfactory uniformity in the patties, because their size depends on the amount of food mix dispensed from the upper chamber into the lower chamber each time. [0007] U.S. Pat. No. 3,934,308 to Neri discloses a patty moulding device including a stationary horizontal base plate and a mould with a through opening providing a mould cavity to accommodate material to be moulded. The mould is moveably mounted with respect to the base plate and is resiliently urged away from the base plate. A core element is detachably secured to the base plate within the mould cavity. The mould is moveable between a first position where the core element is disposed in the bottom of the mould, and a second position where the core element is disposed in a higher position within the mould cavity. Co-operating retaining devices hold the mould and core element in the first position when the mould is not in use. Unfortunately, this design is such that, when the mould is moved to form a patty, there is no place for excess meat to go, if any, resulting in non-uniform patties. [0008] U.S. Pat. No. 3,909,881 to Anderson discloses a two-part cylindrical mould for manufacturing a hollow hamburger. Means are provided for forming a pocket in the meat. The process involves dispensing a metal foil insert into the hamburger to serve as a lining for the pocket. The lining remains in the hamburger during cooking. [0009] U.S. Pat. No. 3,863,020 to Robinson discloses a method of forming a meat patty by pressing a predetermined quantity of minced meat into a mould, which imparts to the patty a series of concentric circular ribs separated by narrow circular grooves. This method suffers disadvantages in that because of the grooves, the patties lack uniformity. In addition, the method involves using plastic to remove the burger from the mould. Additionally, excess meat cannot be removed from the mould. [0010] As will be appreciated, the prior art moulds discussed above do not provide for the formation of uniform patties from food product. It is therefore an object of the present invention to provide a novel press for making patties and method of making patties from food product. SUMMARY OF THE INVENTION [0011] Accordingly, in one aspect of the present invention there is provided a press for making a patty, comprising: [0012] a mould having an opening therethrough; and [0013] a carrying component having a substantially flat panel and a handle affixed to said panel, said flat panel having a surface to contact a product to be pressed into a patty, said handle being sized to pass through said opening to allow said mould to move along said handle, said mould being positionable to overlie said panel and thereby facilitate the application of pressure to said product. [0014] Preferably, the mould is significantly heavier than the flat panel and acts as a weight to facilitate the application of pressure to the product. It is also preferred that the mould is in the form of a disc having top and bottom generally circular surfaces bridged by a smooth, peripheral sidewall. The flat panel corresponds generally in shape and size to the bottom surface of the disc. The opening in the disc is positioned at the centre of the disc and the handle is centrally affixed to the flat panel. Preferably, the mould and carrying component are formed of stainless steel. [0015] In one embodiment, the disc can be removed from the handle while in a second embodiment, the disc, although moveable along the handle, is retained on the handle. [0016] According to another aspect of the present invention there is provided a press for making a food patty comprising: [0017] a substantially flat panel having a generally planar, circular surface to contact food product to be pressed into a patty; [0018] an upstanding member affixed to said panel; and [0019] a weight member surrounding said upstanding member, said weight member being moveable along said upstanding member between a first position where said weight member overlies said panel to facilitate the application of force to said food product and a second position where said weight member is spaced from said panel. [0020] According to another aspect of the present invention there is provided a method of forming a patty from food product using a food press, said food press including a carrying component having a flat panel to contact said food product and a handle affixed to said flat panel to allow said flat panel to be positioned relative to said food product, and a mould moveable along said handle, said method comprising the steps of: [0021] placing food product on a surface; [0022] positioning the flat panel on said food product with said mould overlying the flat panel; [0023] applying pressure to said food press to flatten said food product and form a patty of desired thickness; [0024] removing excess food product extending beyond the periphery of said flat panel and mould; [0025] moving the mould along said handle away from said flat panel; and [0026] separating said flat panel from said patty. [0027] As will be appreciated, the food press in accordance with the present invention allows uniform patties to be made one at a time in a convenient and easy manner while avoiding sticking between the food press and the formed patties. BRIEF DESCRIPTION OF THE DRAWINGS [0028] Embodiments of the present invention will now be described more fully with reference to the accompanying drawings, in which like numerals denote like parts through the several views, and in which: [0029] [0029]FIG. 1 is an exploded perspective view of a food press in accordance with the present invention; [0030] [0030]FIG. 2 is a perspective view of the food press shown in FIG. 1, but with its components in an assembled condition; [0031] FIGS. 3 to 7 are sequential perspective views showing the operation of the food press and the method by which a patty is formed; [0032] [0032]FIG. 8 is a perspective view of an alternative embodiment of a food press in accordance with the present invention; [0033] [0033]FIG. 9 a is a perspective view of a mould forming part of the food press of FIG. 8; and [0034] [0034]FIG. 9 b is a perspective view of a carrying component forming part of the food press of FIG. 8. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0035] Attention is first directed to FIGS. 1 and 2, which show a food press 10 for making a food patty in accordance with the present invention. As can be seen, the food press 10 includes two primary components, namely a mould 12 and a carrying component 14 . Preferably, the mould 12 and carrying component 14 are formed of stainless steel. [0036] In this embodiment, the mould 12 is in the form of a relatively heavy disc having substantially flat, circular top and bottom walls 16 and 18 , bridged by a smooth peripheral sidewall 20 . The mould 12 has a diameter of about 12 cm and a thickness of about 1.5 cm. The diameter of the mould corresponds generally to the ultimate diameter of the food patty to be formed. A central hole 22 is provided through the mould 12 . [0037] The carrying component 14 includes a substantially flat, thin circular panel 24 having a diameter slightly smaller than the diameter of the mould 12 . In this manner, the bottom edge of the mould 12 remains accessible when the mould 12 overlies the panel 24 . The panel 24 is generally rigid and defines a lower surface 24 b to contact food product that is to be pressed into patties. The carrying component 14 further includes an upright handle 26 , which is centrally affixed to the flat panel 24 by a weld. The handle 26 is elongate and is in the form of a solid cylinder. A loop 28 is welded to the upper end of the handle 26 to allow the food press 10 to be hung from a hook for easy storage. [0038] The handle 26 is sized and shaped such that it is adapted to pass easily through the hole 22 in the mould 12 . This allows the mould 12 to be placed on the flat panel 24 and act as a weight when the press 10 is manipulated to form a patty yet be easily moved along the handle 26 away from the flat panel 24 after a patty has been formed. [0039] Attention is now directed to FIGS. 3 to 7 for an explanation of the operation of the food press 10 . During use, a ball 30 of food product such as ground meat or other food product is placed on a flat surface. Typically enough food product is utilized to provide slightly more than the desired amount of food product that is to form the final patty, thus ensuring that there will be excess food product. [0040] At this stage with the mould 12 overlying the flat panel 24 , the food press 10 is positioned to place the flat panel 24 over the ball 30 of food product, and sufficient pressure is applied to the ball 30 by pushing down on the mould 12 thereby to flatten the ball into a patty 32 having the desired thickness as shown in FIGS. 3 and 4. The weight of the mould 12 facilitates this action. Since the ball 30 of food product typically utilizes more food product than is necessary to form the patty of desired thickness, excess food product 34 is ejected from beneath the flat panel 24 and extends beyond the peripheral sidewall 20 of the mould 12 . The excess food product 34 is easily removed or stripped away from the patty 32 by running a finger 36 along the peripheral sidewall 20 as shown in FIG. 5. [0041] With the patty 32 formed and the excess food product 34 removed, the mould 12 is lifted upwardly along the handle 26 and away from the flat panel 24 while maintaining the flat panel on the patty 32 as shown in FIG. 6. Once the mould 12 has been separated from the flat panel 24 , the flat panel 24 is removed from the patty 32 by lifting the carrying component 14 away from the patty using the handle 26 as shown in FIG. 7. Since the weight of the mould 12 is removed from the patty 32 before the flat panel 24 is separated from the patty, the flat panel 24 does not stick to the patty allowing the carrying component 14 to be easily removed from the patty. [0042] Utilizing the present food press 10 in the above described manner produces a patty which is smooth, fully formed and ready for cooking or freezing. The patty forming process is easily reproduced allowing uniform patties to be formed one at the time. [0043] When it becomes necessary to clean the food press 10 , the mould 12 and carrying component 14 are separated in order to provide ready access to all portions of the food press that contact food. [0044] Turning now to FIGS. 8, 9 a and 9 b , an alternative embodiment of a food press in accordance with the present invention is shown and is generally identified by reference numeral 110 . In this embodiment like reference numerals will be used to indicate like components with a “100” added for clarity. The food press 110 is very similar to that of the previous embodiment and includes a mould 112 and a carrying component 114 both of which are formed of stainless steel. The carrying component 114 includes a flat panel 124 and an upright handle 126 centrally affixed to the flat panel 124 by a mould. The upright handle 126 in this embodiment is in the form of a hollow cylinder. The handle 126 passes through an opening 122 in the mould 112 and is sized to permit the mould 112 to move along the handle 126 . An elongate loop 128 is affixed to the open distal end of the handle 126 by a weld and acts as a retainer to inhibit the mould 112 from being removed from the handle. [0045] The food press 110 is used in the same manner as that of the previous embodiment. The mould 112 however, cannot be removed from the handle due to the loop 128 . The mould 112 can however be lifted from the panel 124 toward the loop 128 after a patty has been formed to facilitate separation between the panel 124 and the patty. [0046] Although the mould has been shown as a disc, it will be appreciated that the mould can take other shapes such as a square, hexagon etc. if desired. Also, if desired, the opening in the mould can extend to the peripheral sidewall allowing the mould to be separated from the carrying component by moving the mould laterally away from the handle. In this case, when excess food product is being removed from a formed patty, the mould can be rotated to provide a smooth, finger running peripheral surface. [0047] While preferred embodiments of the present invention have been illustrated in the accompanying drawings and described hereinabove, it will be evident to those skilled in the art that variations and modifications may be made without departing from the spirit and scope of this invention as defined by the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATION [0001] The present application is a Divisional of U.S. patent application Ser. No. 10/960,737, filed on Oct. 7, 2004, in turn a Continuation-in-Part of U.S. patent application Ser. No. 10/366,247, filed on Feb. 13, 2003, which claims priority from U.S. Provisional Patent Application Ser. No. 60/434,262, filed on Dec. 18, 2002. FIELD OF THE INVENTION [0002] The present invention relates to a catheter guidewire and a method of retaining a catheter guidewire in a guidewire tube. BACKGROUND OF THE INVENTION [0003] Catheter guidewires are used to facilitate introduction of a catheter into a patient. In a typical catheter installation, an insertion site is located, and an incision is made by the inserting physician at the insertion site. A syringe is inserted into the patient through the incision to locate the blood vessel, such as a vein, to be catheterized. A flexible metal guidewire is typically inserted through the syringe and into the blood vessel to further enable the inserting physician to insert the catheter into the patient. The guidewire typically has a “J-shaped” distal end, so as not to tear into the patient's blood vessel during insertion. The guidewire is quite flexible so that it can bend with the contours of the blood vessel, but the flexibility of the guidewire, along with the “J-shape”, can make it difficult for the physician to insert the distal end of the guidewire into the syringe. Guidewire straighteners are used to straighten out the “J-shape” and to assist the physician in inserting the distal tip of the guidewire into the syringe for advancement into the blood vessel. [0004] A guidewire is typically stored in a coiled plastic tube, both for ease of physician use and for sterility. However, during shipping, the guidewire can work its way out of the tube, making the guidewire more difficult to handle and potentially compromising the sterility of the guidewire. [0005] A known guidewire straightener is disclosed in U.S. Pat. No. 5,125,905. This guidewire straightener utilizes a cantilevered extension at the proximal end of the straightener to grasp a guidewire and retain the guidewire in its tube. It is believed by the inventors that the prior art design does not provide sufficient gripping between the straightener and the guidewire. It is also believed by the inventors that the prior art design may be prone to breakage from fatigue. [0006] It would be beneficial to provide a guidewire straightener that provides increased gripping between the straightener and the guidewire so that the guidewire does not work its way out of the tube, as well as a guidewire straightener that is less prone to breakage from fatigue. BRIEF SUMMARY OF THE INVENTION [0007] Briefly, the present invention provides a guidewire straightener assembly. The assembly comprises a guidewire tube including a tubular passage having a first diameter and a distal end including a collar having a second diameter, larger than the first diameter. The assembly also includes a guidewire straightener having a distal end, a proximal end having an exterior surface with a diameter sized to fit within the guidewire tube, and a longitudinal passageway sized to accept the guidewire, the passageway extending between the proximal end and the distal end. The assembly further includes a guidewire having a third diameter, smaller than the first diameter, wherein the guidewire is disposed within the tubular passage and the longitudinal passageway. The proximal end of the guidewire straightener further includes at least one finger extending therefrom such that, when the guidewire straightener is disposed within the guidewire tube in a first position in the tubular passage, the at least one finger is biased by the tubular passage into frictional engagement with the guidewire. When the guidewire straightener is disposed within the guidewire tube in a second position in the collar, the at least one finger is disposed away from frictional engagement with the guidewire. [0008] The present invention also provides a catheter guidewire tube comprising a body having a distal end, a proximal end, and a tube passageway extending between the distal end and the proximal end, wherein the tube has a first diameter. The assembly also includes a collar fixedly connected to the distal end, wherein the collar comprises a longitudinal passage having a second diameter, larger than the first diameter, and wherein the collar further comprises a distal opening having a third diameter, smaller than the second diameter. BRIEF DESCRIPTION OF THE DRAWINGS [0009] The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings: [0010] FIG. 1 is a perspective view of a catheter guidewire straightener according to an embodiment of the present invention. [0011] FIG. 2 is a side elevational view of the catheter guidewire straightener shown in FIG. 1 . [0012] FIG. 3 is a sectional view of the catheter guidewire straightener taken along line 3 - 3 of FIG. 2 . [0013] FIG. 4 is a plan view of a catheter guidewire assembly incorporating the catheter guidewire straightener shown in FIGS. 1-3 . [0014] FIG. 5 is a sectional view of the catheter guidewire assembly taken along line 5 - 5 of FIG. 4 . [0015] FIG. 6 is a schematic view showing operation of the catheter guidewire assembly during insertion of a guidewire into a patient. [0016] FIG. 7 is a side profile view of a catheter guidewire straightener assembly according to a second embodiment of the present invention. [0017] FIG. 8 is an enlarged sectional view of the guidewire straightener assembly of FIG. 7 , taken along lines 8 - 8 of FIG. 9 . [0018] FIG. 9 is an enlarged sectional view of the guidewire straightener assembly of FIG. 7 , taken along lines 9 - 9 thereof. [0019] FIG. 10 is an enlarged sectional view of the guidewire straightener assembly of FIG. 7 , with the guidewire straightener removed from the guidewire tube. [0020] FIG. 11 is a sectional view of a catheter guidewire straightener assembly according to a third embodiment of the present invention. [0021] FIG. 12 is a sectional view of the catheter guidewire straightener assembly shown in FIG. 11 , with the guidewire straightener removed from the guidewire tube. [0022] FIG. 13 is a sectional view of a guidewire straightener assembly according to a fourth embodiment of the present invention. [0023] FIG. 14 is a sectional view of the guidewire straightener assembly of FIG. 13 , with the guidewire straightener disconnected from the guidewire tube. DETAILED DESCRIPTION OF THE INVENTION [0024] In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The words “proximal” and “distal” refer to directions away from and closer to, respectively, the insertion tip of the guidewire in the guidewire assembly according to the present invention. The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. The following describes a preferred embodiment of the invention. However, it should be understood based on this disclosure, that the invention is not limited by the preferred embodiment described herein. [0025] A catheter guidewire straightener 10 according to an embodiment of the present invention is shown in FIGS. 1-3 . The guidewire straightener 10 is comprised of a generally frusto-conically shaped distal end 12 and a generally cylindrically shaped proximal end 14 . A stop collar 16 is disposed between the distal end 12 and the proximal end 14 . A straightener passageway 18 extends through the guidewire straightener 10 between the distal end 12 and the proximal end 14 . The straightener passageway 18 is sized to allow a guidewire 52 , shown in a guidewire assembly 50 in FIG. 4 , to pass through the straightener passageway 18 with little or no interference. A standard guidewire has a diameter of approximately 0.038 inches (approximately 0.97 mm), and the straightener passageway 18 has a diameter of approximately 0.05 inches (approximately 1.27 mm). Therefore, when the guidewire 52 is inserted into the straightener passageway 18 , a clearance of approximately 0.012 inches (approximately 0.30 mm) is provided between the guidewire 52 and the guidewire straightener 10 . [0026] Referring back to FIGS. 1-3 , the proximal end 14 of the straightener 10 includes first and second diametrically opposed biasing assemblies 20 , 22 , which are each comprised of a lug 24 disposed on a biasing member 26 , such as a leaf spring. A distance between free ends of each lug 24 on the biasing assemblies 20 , 22 , as shown in FIG. 2 , is defined as a diameter “D”. [0027] Each biasing assembly 20 , 22 , extends longitudinally along the proximal end 14 of the straightener 10 , with channels 28 , 30 disposed on either side of the biasing assemblies 20 , 22 . The channels 28 , 30 allow the lugs 24 and the biasing members 26 to deflect toward the straightener passageway 18 when force is applied on the lugs 24 toward the straightener passageway 18 . The biasing members 26 resist such force and bias the lugs 24 away from the straightener passageway 18 . [0028] Preferably, the guidewire straightener 10 is constructed from a polymer, such as polypropylene, although those skilled in the art will recognize that other, suitable materials may be used. [0029] A guidewire assembly 50 incorporating the guidewire straightener 10 of the present invention is shown in FIGS. 4 and 5 . The guidewire assembly 50 is comprised of a guidewire 52 disposed within a tube passageway 54 of a guidewire tube 56 . The guidewire 52 has a “J-shaped” distal end 53 . The tube passageway 54 has an inner diameter “d”. The guidewire tube 56 is connected to the proximal end 14 of the guidewire straightener 10 . [0030] The guidewire tube 56 is preferably coiled as shown for the ease of the user. The guidewire 52 is typically approximately 24 inches (61 cm) long and, by coiling the guidewire 52 along with the guidewire tube 56 , the user can more readily handle the guidewire 52 and advance the guidewire 52 into the patient. [0031] The guidewire tube 56 includes an open distal end 58 , through which the guidewire 52 is advanced, the distal end 58 having a collar with an inner diameter larger than tube passageway diameter “d”. The distal end 58 of the guidewire tube 56 is inserted over the proximal end 14 of the guidewire straightener 10 , so that the distal end 58 of the guidewire tube 56 and the proximal end of the guidewire straightener 10 engage each other with a press fit. [0032] The diameter “D” of the lugs 24 is larger than the diameter “d” of the tube passageway 54 so that, as is seen in FIG. 5 , the distal end collar of guidewire tube 56 biases the lugs 24 and the biasing members 26 into the straightener passageway 18 . Each lug 24 biases its respective biasing member 26 against the guidewire 52 so that the guidewire 52 is longitudinally engaged along a length of the guidewire 52 by the biasing members 26 . The biasing members 26 , in turn, bias the lugs 24 against the tube's collar to releasably retain the straightener 10 in the tube 56 . [0033] Referring now to the guidewire insertion procedure of FIG. 6 during a catheter insertion procedure, an incision 110 is initially made near an insertion site 112 which is to be aspirated with a syringe or other introducer apparatus near or proximate the area to be catheterized. If the catheter is used for hemodialysis and the area to be catheterized is the internal jugular vein 116 , the incision 110 is made in the clavicular triangle region, as shown for example, in FIG. 6 . The exact location of the incision 110 can be varied by the physician. In accordance with the Seldinger technique, a narrow needle 114 connected to the syringe is inserted through the incision 110 and into the vein 116 , and the vein 116 is aspirated. The syringe is disconnected from the needle 114 , leaving the needle 114 in the vein 116 . [0034] The guidewire 52 is next inserted into the vein 116 through the needle 114 . To insert the guidewire 52 into the vein 116 , the proximal end 14 of the straightener 10 is removed from the tube 56 . The biasing members 26 bias away from the straightener passageway 18 , releasing the guidewire 52 from between the biasing members 26 . The distal end 53 (see FIGS. 4 and 5 ) of the guidewire 52 is then retracted into the straightener 10 so that the “J-shaped” distal end 53 of the guidewire 52 is disposed within the straightener 10 . The distal end 12 of the straightener 10 is then inserted into the proximal end of the needle 114 . The preferably frusto-conical shape of the distal end 12 facilitates insertion of the distal end 12 into the needle 114 . [0035] Using thumb 118 and forefinger 120 on the guidewire 52 between the straightener 10 and the tube 56 , the physician advances the guidewire 52 through the needle 114 and into the vein 116 . Once the guidewire 52 is in place, the tube 56 and the straightener 10 are removed by advancing each of the tube 56 and the straightener 10 along the guidewire 52 away from the distal end 53 of the guidewire 52 and then off the proximal end of the guidewire 52 . Next, the needle 114 is removed by advancing the needle 114 along the guidewire 52 away from the distal end 53 of the guidewire 52 and then off the proximal end of the guidewire 52 . A dilator (not shown) and a tearable sheath (not shown) are introduced over the guidewire 52 and partially into the vein 116 . The insertion site 112 is now ready to accept a catheter assembly (not shown). At least one catheter lumen is disposed over the proximal end of the guidewire 52 and advanced toward the distal end 53 of the guidewire 52 and into the vein. [0036] An alternate embodiment of a guidewire straightener assembly 200 is shown in FIG. 7 . The assembly 200 includes a straightener 210 and a guidewire tube 250 . The straightener 210 is partially disposed in the tube 250 and is used to assist the inserting physician in advancing a guidewire 202 from the tube 250 during catheter insertion. [0037] Referring to FIG. 8 , the straightener 210 includes a distal end 212 that is generally conically or frusto-conically shaped. The distal end 212 is shaped to facilitate insertion of the distal end 212 into an introducer device, such as an introducer needle (not shown). The straightener 210 also includes a proximal end 214 that includes a biasing member 216 . A longitudinal axis 217 extends through the straightener 210 . A straightener passageway 218 extends along the longitudinal axis 217 through the straightener 210 between the distal end 212 and the proximal end 214 . The passageway 218 has a diameter D 1 that is sized to allow the guidewire 202 to be able to be translated therethrough with a minimal force during insertion of the guidewire 202 into the patient. [0038] The biasing member 216 includes a plurality of fingers 220 that extend in a proximal direction. While eight fingers 220 are shown in FIG. 9 , those skilled in the art will recognize that more or less than eight fingers 220 may be used. Each finger 220 has a connected end 222 that is connected to the proximal end 214 and a free end 224 that freely extends away from the proximal end 214 . Each finger 220 has a body portion 226 between the connected end 222 and the free end 224 that is biased away from the longitudinal axis 217 . The biasing member 216 is dimensioned such that, when the biasing member 216 is disposed within the guidewire tube 250 , the interior wall of the guidewire tube 250 biases the biasing member 216 against the guidewire 202 . [0039] The guidewire advancer 210 also includes a generally elongated portion 230 that extends between the distal end 212 and the proximal end 214 . The generally elongated portion 230 extends below the guidewire 202 and is open so that the guidewire 202 is accessible. A generally convex raised portion 232 extends from the generally elongated portion 230 and provides a thumb rest for advancing the guidewire 202 distally through the advancer 210 . [0040] The guidewire tube 250 includes a distal end 252 that engages the straightener 210 . The guidewire tube 250 has an inner diameter D 2 that is sized to allow the proximal end 214 of the straightener 210 to be inserted into the guidewire tube 250 . The guidewire tube 250 also has an outer diameter D 3 . A cylindrical collar 260 is fixedly connected to the distal end 252 of the tube 250 . [0041] The collar 260 is preferably constructed from a polymer, such as polypropylene, or some other suitable material. Those skilled in the art will recognize that the collar 260 may be a separate piece from the tube 250 , or the collar 260 may be integrally formed with the tube 250 . If the collar 260 is a separate piece from the tube 250 , the collar 260 is fixedly connected to the tube 250 by known methods, such as by an adhesive, by ultrasonic welding, or other means known in the art for connecting the collar 260 to the tube 250 . [0042] The collar 260 includes a proximal collar end 262 that fits over the exterior of the distal end 252 of the tube 250 . The collar 260 also includes a distal collar end 264 that has an inner diameter D 4 that is larger than the outer diameter D 3 of the tube 250 . The distal collar end 264 includes an opening 265 along the longitudinal axis 217 that is sized to allow the proximal end 214 of the straightener 210 to be inserted into the opening 265 . The inner diameter D 4 of the distal collar end 264 is sufficiently large to allow the biasing member 216 to expand within the interior of the distal collar end 264 to allow the biasing member 216 to expand and release the guidewire 202 . However, it is preferred that the distal opening 265 is sufficiently small such that the biasing member 216 cannot be easily pulled through the distal opening 265 and out of the collar 260 . [0043] The collar 260 also includes a tapered portion 266 that tapers from the proximal collar end 262 , outward to the distal collar end 264 . Preferably, the tapered portion 266 begins at the distal end 252 of the tube 250 , although those skilled in the art will recognize that the tapered portion 266 may begin either proximally or distally of the distal end 252 of the tube 250 . [0044] The assembly 200 is provided with the straightener 210 fully inserted into the tube 250 , as shown in FIGS. 7 and 8 . In use, the straightener 210 is partially removed from the tube 250 by advancing the straightener 210 in a distal direction relative to the tube 250 . The biasing means 216 moves distally from the interior of the tube 250 to the interior of the collar 260 to the position shown in FIG. 10 . When the plurality of fingers 220 enter the interior of the collar 260 , the fingers 220 spring away from the guidewire 202 , allowing the guidewire 202 to be freely advanced from the distal end 212 of the straightener 210 according to known methods. The straightener 210 , however, is not sufficiently moved relative to the tube 250 so as to pull the proximal end 214 of the straightener 210 through the distal opening 265 of the collar 260 . [0045] After the guidewire 202 is inserted a desired distance into the patient, the guidewire straightener assembly 200 is removed from the guidewire 202 by sliding the assembly 200 proximally along the guidewire 202 until the guidewire 202 exits the assembly 200 . The assembly 200 is discarded and the catheter insertion procedure continues according to steps and processes well known in the art. [0046] While the guidewire assembly 200 with the collar 260 fixed to the distal end 252 of the tube 250 is preferred, those skilled in the art will recognize that a guidewire assembly 300 , shown in FIG. 11 , that omits the collar may be used. The straightener 210 is inserted into the tube 250 as shown in FIG. 11 , with the fingers 220 biased against the guidewire 202 . [0047] In use, the straightener 210 is advanced distally with respect to the tube 250 until the proximal end 214 of the straightener 210 is removed from the tube, as show in FIG. 12 . The fingers 220 spring away from the guidewire 202 , allowing the guidewire 202 to be freely advanced from the distal end 212 of the straightener 210 . The user biases the guidewire 202 against the generally convex raised portion 232 and advances his/her thumb in a distal direction, using friction to distally advance the guidewire 202 as well. [0048] After the guidewire 202 is inserted a desired distance into the patient, the guidewire straightener assembly 300 is removed from the guidewire 202 by sliding the assembly 300 proximally along the guidewire 202 until the guidewire 202 exits the assembly 200 . The assembly 300 is discarded and the catheter insertion procedure continues according to steps and processes well known in the art. [0049] Yet another embodiment of the present invention is shown in FIGS. 13 and 14 . A guidewire straightener assembly 400 includes a guidewire straightener 410 and a guidewire tube 450 that are used to retain and dispense a guidewire 402 . A swivel lock assembly 460 releasably connects the straightener 410 and the tube 450 to each other. [0050] The straightener 410 includes a distal end 412 that is generally conically or frusto-conically shaped. The distal end 412 is shaped to facilitate insertion of the distal end 412 into an introducer device, such as an introducer needle (not shown). The straightener 410 also includes a proximal end 414 that includes a biasing member 416 . A longitudinal axis 417 extends through the straightener 410 . A straightener passageway 418 extends along the longitudinal axis 417 through the straightener 410 between the distal end 412 and the proximal end 414 . The passageway 418 has a diameter D 1 that is sized to allow the guidewire 402 to be able to be translated therethrough with a minimal force during insertion of the guidewire 402 into the patient. [0051] The biasing member 416 includes a plurality of fingers 420 that extend in a proximal direction. Similar to the biasing member 216 described above and shown in FIG. 9 , the biasing member 416 preferably includes six fingers 420 . While six fingers 420 are preferred, those skilled in the art will recognize that more or less than six fingers 420 may be used. Each finger 420 has a proximal end 422 that is connected to the proximal end 414 and a distal end 424 that extends away from the proximal end 414 . Each finger 420 has a body portion 426 between the proximal end 422 and the distal end 424 that is biased away from the longitudinal axis 417 . The biasing member 416 is dimensioned such that, when the biasing member 416 is disposed within the guidewire tube 450 , the interior wall of the guidewire tube 450 biases the biasing member 416 against the guidewire 402 , restricting the movement of the guidewire 402 within the tube 450 . [0052] The straightener 410 includes an annular groove 430 disposed between the distal end 412 and the proximal end 414 . The groove 430 is sized and shaped to allow the distal end of the swivel lock assembly 460 to be rotatably attached to the straightener 410 , as will be described more in detail later herein. [0053] The guidewire tube 450 includes a distal end 452 that engages the straightener 410 . The guidewire tube 450 has an inner diameter D 2 that is sized to allow the proximal end 414 of the straightener 410 to be inserted into the guidewire tube 450 . The guidewire tube 450 also has an outer diameter D 3 . The swivel lock assembly 460 includes a cylindrical collar 462 that is fixedly connected to the distal end 452 of the tube 450 and a swivel lock 470 that is rotatably connected to the straightener 410 . [0054] The collar 462 is preferably constructed from a polymer, such as polypropylene, or some other suitable material. Those skilled in the art will recognize that the collar 462 may be a separate piece from the tube 450 , or the collar 462 may be integrally formed with the tube 450 . If the collar is a separate piece from the tube 450 , the collar 462 is fixedly connected to the tube 450 by known methods, such as by an adhesive, by ultrasonic welding, or other means known in the art for connecting the collar 462 to the tube 450 . Preferably, the collar 462 includes a stop 461 that limits the distance that the collar 462 may be advanced over the distal end 452 of the tube 450 . [0055] The collar 462 includes a distal collar end 464 that includes male threads 466 . The swivel lock 470 includes female threads 472 that threadingly engage with the male threads 466 . A distal end of the swivel lock 470 includes a lip 474 that rotates within the groove 430 in the straightener 410 to allow the swivel lock 470 to rotate about the longitudinal axis 417 with respect to the straightener 410 . [0056] The assembly 400 is provided with the straightener 410 fully inserted into the tube 450 and the swivel lock 470 connected to the collar 462 , as shown in FIG. 13 . In use, the straightener 410 is removed from the tube 450 by rotating the swivel lock 470 relative to the collar 462 and unthreading the female threads 472 from the male threads 466 . When the swivel lock 470 is unthreaded from the collar 462 , the straightener 410 is advanced in a distal direction relative to the tube 450 . The biasing means 416 moves distally from the interior of the tube 450 to the position shown in FIG. 14 . When the plurality of fingers 420 exits the distal end 452 of the tube 450 , the fingers 420 spring away from the guidewire 402 , allowing the guidewire 402 to be freely advanced from the distal end 412 of the straightener 410 according to known methods. [0057] After the guidewire 402 is inserted a desired distance into the patient, the guidewire straightener assembly 400 is removed from the guidewire 402 by sliding the assembly 400 proximally along the guidewire 402 until the guidewire 402 exits the assembly 400 . The assembly 400 is discarded and the catheter insertion procedure continues according to steps and processes well known in the art. [0058] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

1a

BACKGROUND OF THE INVENTION The present invention relates to a method and an apparatus for facilitating the removal of a prosthetic implant from a body and, more specifically, to the use of fluid pressure to effect said removal. An orthopaedic implant is typically placed in a bone having a prepared bed formed to the implant shape. The bed fits the implant loosely and a plastic cement fills the space between the implant and the bone to securely fix the implant. Due to implant failure or other complications it is occasionally necessary to remove the implant. A variety of means have been proposed for such removal including impacting devices for driving the implant out, powered and manual instruments for excavating the cement from about the implant, and means for heating or ultrasonically vibrating the implant or instruments to soften the cement. These prior devices have been employed with varying levels of safety, efficacy, and economy. Further, they have been limited to use with rigid metallic implants because of their dependence on energy being conducted through the implant. SUMMARY OF THE INVENTION The invention of this disclosure provides a reliable, uncomplicated method and means to safely remove an orthopaedic implant by employing fluid pressure applied directly to the interface between the implant and the cement to deform the cement and thereby loosen the implant. The invention may be effectively employed with implants constructed of a variety of materials, even those that are highly flexible or that are insulators with respect to thermal and vibratory energy. Such materials include plastics, composites and ceramics, which constitute an increasingly important group of implant materials. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of an implant in situ. FIG. 2 is a partial sectional view of the apparatus of the invention showing its interaction with a portion of an implant and bone. DETAILED DESCRIPTION OF THE INVENTION Referring to FIGS. 1 and 2, an exemplary implant 1 is depicted as a femoral hip implant cemented into a human femur 2. The implant is secured in the femur by a layer 3 of acrylic bone cement which grips the implant due to interdigitation with micro and macro surface features along the interface, or bond line, which exists between the cement and implant. The implant may be loosened according to the present invention by pressurizing fluid at the interface. The fluid pressure stretches the cement enough to relieve its grip on the implant. The cement layer is also vulnerable to fracture and separation due to the fluid pressure. Such separation would likely occur at regions of minimum cross sectional thickness. This method and apparatus can be applied to any suitable implant including femoral and acetabular hip implants, femoral and tibial knee implants, shoulder implants, and elbow implants. It may also be employed with any fixing material including plastic bone cements, plasters, and other luting agents. Fluid access to the interface may be provided by creating an access port 4 through the cement layer, such as by drilling. Drilling may be aided by a drill guide 5, as shown in FIG. 1, which attaches to the implant and directs the drill to an appropriate region 6 of the interface. Likewise, a port could be made in the implant. Fluid access may also be provided by holes or channels already existing in the cement or implant. Such an access port could be part of the implant when it is sold. Fluid is then supplied to the interface. Any fluid may be used, however, the fluid is preferably an incompressible liquid such as saline. It is also preferable that the fluid is introduced so as to eliminate air from the port. This can be accomplished by injecting fluid into the port from the bottom using a hypodermic needle. Next the port is sealed with a pressure fitting 7. Any fitting that will form a seal with the port may be used. Suitable fittings include a threaded fitting, a tapered press fitting, and a cemented fitting. An alternate fitting 8 may include a portion 9 to extend substantially to the bottom of the port to improve the seal or to extend through a portion of bone. The fitting should be well sealed to the port. During pressurization the fitting will be subject to a separation force. For example, a fixing material such as polymethly-methacrylate (PMMA) bone cement has a tensile strength of approximately 8000 psi. If a port 0.040 inches in diameter is used, then a separation force of ten pounds would be exerted on the fitting at 8000 psi. The fitting is connected to a pressurizing device such as a cylinder 10 having a piston 11 advanced by a screw 12. Preferably the system includes a pressure gauge 13 for monitoring the fluid pressure. A system as described above and that is well sealed to prevent leaks is inherently safe as explained in the following description of its operation. The screw is turned to advance the piston which forces fluid into the port and thereby increases the fluid pressure at the interface. When the pressure reaches a critical value the cement will separate from the implant or the cement will fracture or both. As this occurs, the fluid pressure will decrease dramatically so that a high pressure fluid can not be injected into the bone. Furthermore, only a small volume of fluid is necessary. The piston can be advanced again. If the crack or separation is only partial, the pressure will build rapidly again and the cycle will repeat. If the crack or separation is complete then the pressure will not build and the implant can be removed or pressure can be applied to another region of the interface. While a piston advanced by a screw has been described, any means for pressurizing the fluid may be used including various manual and powered pumps or pneumatically charged chambers. In the case of a device that can continue to supply pressure it is desirable to include means to monitor the pressure and suspend the supply when a crack or separation is detected. Mechanical energy in addition to the fluid pressure may be advantageously applied to the implant. Striking, pulling, or vibrating the implant prior to, in conjunction with, or after supplying fluid pressure to the implant may aid in loosening the implant according to this method. While the foregoing has described an exemplary preferred embodiment of the present invention, it will be understood by those skilled in the art that modifications can be made without departing from the spirit and scope of the invention defined by the appended claims.

1a

BACKGROUND [0001] This version of the invention is concerned with the field of bird suet dispensers. More specifically, this version of the invention is concerned with a bird suet dispenser allowing songbirds and woodpeckers access to suet stored therein while preventing unwanted birds access to suet stored therein. PRIOR ART [0002] Bird feeders are available in a wide variety of designs, shapes, and configurations so as to provide bird food for numerous songbirds, woodpeckers, hummingbirds, and the like. Generally, bird feeders hold and dispense three basic types of bird feed: 1) loose bird feed, such as black sunflower seeds; 2) solids or cakes, such as suet or seed cakes, available in various shapes, such as square blocks or cylinders; and 3) liquid bird feed, such as sugar or flavored water for hummingbirds. A basic design consideration of any bird feeder is how to make the bird food stored therein available for the intended birds while shielding the bird food from unwanted birds or other animals, such as squirrels, raccoons, or other unwanted animals. For instance, some bird feeders are designed or can be modified with shields, domes, and the like to prevent squirrels from reaching the bird feeder. Similarly, other bird feeders are constructed with a relatively small perch or perch area to prevent unwanted birds from using the bird feeder, such as jays, crows, grackles, starlings, or birds that travel in flocks. [0003] Starlings can present a particular problem when attempting to provide bird food to songbirds and woodpeckers. Starlings travel in large flocks and will descend upon a feeding area or bird feeder in great numbers, disturbing and chasing away feeding birds. In addition, starlings at smaller numbers are still problematic, as they possess an aggressive temperament and will intimidate the more docile songbirds and woodpeckers. [0004] The subject of the instant invention introduces a bird suet dispenser along with a training basket that stores suet and other feed cakes therein, making access to said bird food available to certain desired birds, such as songbirds and woodpeckers, while preventing access of said bird food to starlings and other pest birds. The bird suet dispenser overcomes the disadvantages of previous designs by introducing a novel suet dispenser that can be adapted to acclimate and train in conjunction with the training basket a variety of desired birds to feed from said dispenser while excluding unwanted and disruptive birds. DISCUSSION OF THE PRIOR ART [0005] Numerous designs for bird feeders have been provided in the prior art. Even though these designs may be suitable for the specific individual purposes to which they address, they would not be suitable for the purposes of the present version of the invention as such designs are intended for use with loose bird seed, either with a conventional bird feeder or a bird feeder attempting to limit access to certain, desired birds. Furthermore, such designs, while limiting access of bird food to certain, desired birds, do so in a manner that makes the bird food difficult to obtain and do not provide adequate transition from completely open access to limited access. These designs are exemplified by the following patents: [0000] U.S. Pat. No. 4,144,842, Access Limiting Bird Feeder, issued to Schlising on 20 Mar. 1979; [0000] U.S. Pat. No. 4,462,337, Bird Feeder With Rotatable Cover, issued to Kilham on 31 Jul. 1984; [0000] U.S. Pat. No. 4,646,686, Selective Bird Feeder, issued to Furlani on 3 Mar. 1987; [0000] U.S. Pat. No. 5,163,382, Bird Feeder Apparatus, issued to Morrison on 17 Nov. 1992; [0000] U.S. Pat. No. 5,295,455, Bird Excluding Technique, issued to Johnson on 22 Mar. 1994; [0000] U.S. Pat. No. 5,297,503, Bird Feeder Protector, issued to Hibbard on 29 Mar. 1994; and [0000] U.S. Pat. No. 5,479,878, Bird Feeder, issued to Coulter on 2 Jan. 1996. [0006] As illustrated by the background art, efforts are continuously being made in an attempt to develop bird feeders for various birds, especially bird feeders that limit access of bird food to certain, desired birds. No prior effort, however, provides the benefits attendant with the present invention. As such, it may be appreciated that there is a continuing need for a new and improved bird suet dispenser that can be adapted over time from providing complete and open access to bird food stored therein to providing limited access, allowing only certain, desired birds to find and reach said bird food. As necessary, the bird suet dispenser also provides a transitional or training period for said desired birds to become acquainted with bird suet available in limited access. In doing so, the bird suet dispenser does not overly restrict or interfere with the ability of said birds to find and reach bird suet stored therein. In these respects, the present version of the invention substantially departs from the conventional concepts and designs of the prior art, and in so doing provides an apparatus that substantially fulfills this need. Additionally, the prior patents and commercial techniques do not suggest the present inventive combination of component elements arranged and configured as disclosed herein. [0007] The present invention achieves its intended purposes, objects, and advantages through a new, useful and unobvious combination of method steps and component elements, with the use of a minimum number of functioning parts, at a reasonable cost to manufacture, and by employing only readily available materials. SUMMARY [0008] The present version of the invention, which will be described in greater detail hereinafter, relates to the field of bird suet dispensers. More specifically, this version of the invention is concerned with a bird suet dispenser allowing songbirds and woodpeckers access to suet stored therein while preventing unwanted birds access to suet stored therein. My version of the invention overcomes all of the shortcomings listed previously, in addition to novel aspects that will be described in detail hereinafter. [0009] Described briefly, according to a typical embodiment, the invention presents a selective bird suet dispenser that is comprised in part of a hollow cylindrical member having first and second opposed ends. First and second opposed apertures are located within the cylindrical member proximate to the first or top end thereof, and eight indentations are located within said cylindrical member at the second or bottom end thereof. A conically-shaped bottom cap is attached to the bottom end of the cylindrical member, said bottom cap having a central aperture and eight rods extending angularly from the a bottom rim of the bottom cap. The rods terminate at attachment to the cylindrical member within cooperating indentations, said rods forming a circular pattern commensurate with the diameter of the bottom end of the cylindrical member. Eight spaces or open areas are located between the rods, allowing access to the interior of the cylindrical member. A threaded fastener is disposed within the central aperture of the bottom cap and extends therefrom for some distance below said bottom cap. [0010] First and second spacers are disposed within said first and second apertures of the cylindrical member, and first and second pins are disposed in respective first and second spacers. A portion of the shank of each pin extends beyond a cooperating fastener away from exterior sidewall of said cylindrical member, and an aperture is located within said portion of shank of each pin extending beyond cooperating fastener. [0011] A cylindrical top cap is located on the first or top end of the cylindrical member. First and second projections are located on opposed sides of the top cap, said projections each having a central aperture therein. An elongate, looped handle with first and second ends is attached to the top cap and pins located within cooperating spacers and apertures of the cylindrical member. First and second ends of the handle are disposed within apertures of cooperating projections of the top cap and apertures of cooperating pins located within the cylindrical member. In this manner, the top cap can be detached from the cylindrical member, sliding along opposed ends of the handle and rotated with respect to the cylindrical member by means of the handle pivoting in response to said pins rotating within respective fasteners located within respective apertures of the cylindrical member. [0012] A conically-shaped hood is slidingly attached to the exterior of the cylindrical member. A flange is located at the first or top end of the hood and makes direct contact with the cylindrical member. A clamp with opposed ends that receive a threaded fastener is fitted over the flange. The clamp can be tightened or loosened as necessary by the threaded fastener to exert or release pressure upon the flange so as to allow repositioning of the hood upon the cylindrical member. [0013] An elongate, cylindrical perch is attached to the under side of the bottom cap. The perch at one end thereof contains a bore, which receives the threaded fastener extending below the bottom cap. A series of rings is located upon the exterior of the perch, each ring separated by a groove. [0014] The cylindrical member, caps, hood, and clamp are comprised of material that is light weight, rigid, and impervious to corrosion and oxidation, such as various non-ferrous metals, plastics, fiberglass, composite materials, and the like. The perch is comprised of material appropriate for birds to land and perch thereon, such as various hardwoods configured with either a natural, textured surface or one that is machined smooth. [0015] To use the selective bird suet dispenser, the top cap is removed from the cylindrical member as described previously, and a cylindrically-shaped section of bird suet or seed cake is inserted into the interior of said cylindrical member. The bird suet rests upon the conically-shaped bottom cap of the cylindrical member, and access to the bird suet is provided by the eight open areas or spaces between said eight rods extending from bottom cap and attached to second or bottom end of the cylindrical member. The bird suet dispenser is then hung upon a tree branch, bird feeder post, or the like. During initial use of the bird suet dispenser, the hood is located proximate to the first or top end of the cylindrical member so as to provide maximum exposure of the suet cake located between the bottom end of the cylindrical member and bottom cap and between eight rods extending from said bottom cap. As desired songbirds and woodpeckers become acclimated with the bird suet dispenser, the hood can be lowered upon the cylindrical member until the suet is completely shielded from view of starlings and pest birds. The songbirds and woodpeckers, trained to recall that suet is available through the openings of the bottom cap of the cylindrical member, will land upon the perch and climb up the perch until reaching the suet. In the meantime, the suet will be completely shielded from view of starlings and other pest birds. [0016] If necessary, a training basket is used to train songbirds and woodpeckers to use the bird suet dispenser or to assist in the transition from complete access to the suet to limited access to said suet. The training basket is comprised of a basket proper with openings, a handle pivotally attached at the top side of said basket proper, and a perch attached to the bottom side of said basket proper. A section of bird suet or feed cake is inserted into the basket proper, and the training basket is hung by the handle upon a tree branch, bird feeder post, or the like. The basket with openings reveals the bird suet or feed cake to a greater degree than the cylindrical member, attracting desired songbirds and woodpeckers to land upon the perch and climb up the perch to reach exposed bird suet or feed cake. [0017] My invention, therefore, resides not in any one of these features per se, but rather in the particular combination of all of them herein disclosed. It is distinguished from the prior art in this particular combination of all of its structures for the functions specified. [0018] In order that the detailed description of the invention may be better understood and that the present contribution to the art can be more fully appreciated, additional features of the invention will be described hereinafter. It should be appreciated by those skilled in the art that the conception and the disclosed specific methods and structures may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should be realized by those skilled in the art that such equivalent methods and structures do not depart from the spirit and scope of the invention. [0019] In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. [0020] 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. [0021] 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 nor is it intended to be limiting as to the scope of the invention in any way. [0022] Accordingly, it is an object of my version of the invention to provide a low-cost, easy-to-manufacture, and easy-to-market selective bird suet dispenser. [0023] A further object of my version of the invention is to provide an easy-to-use and versatile selective bird suet dispenser. [0024] A significant object of the invention is to provide a selective bird suet dispenser that is comprised of a hollow cylindrical member having first and second opposed ends; an elongate, looped handle pivotally attached to the cylindrical member at the first or top end thereof; a top cap slidingly attached to said handle and located upon first or top end of said cylindrical member; a bottom cap with openings, said bottom cap attached to the cylindrical member at the second or bottom end thereof; an elongate cylindrical perch secured to the under side of said bottom cap; and a hollow cone slidingly attached to exterior of said cylindrical member, said cone able to be repositioned at various locations upon said cylindrical member to adjust access to suet stored within said cylindrical member and exposed though openings of said bottom cap. [0025] A final but very significant object of the invention is to provide a selective bird suet dispenser that stores suet bird food and provides access to said bird suet for certain, desired songbirds and woodpeckers while preventing access of said bird suet to certain pest birds without restricting the ability of said desired birds to find and reach bird suet stored therein and, as necessary, allowing said desired birds to be trained and acquainted with bird suet available in limited access. [0026] For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be made to the accompanying drawings and descriptive matter in which there is illustrated a preferred embodiment of the invention. The foregoing has outlined some of the more pertinent objects of the invention. These objects should be construed to be merely illustrative of some of the more prominent features and applications of the present invention. Many other beneficial results can be attained by applying the disclosed invention in a different manner or by modifying the invention within the scope of the disclosure. Accordingly, other objects and a fuller understanding of the invention may be had by referring to the summary of the invention and the detailed description of the preferred embodiment in addition to the scope of the invention illustrated by the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0027] The foregoing and other objects, features and advantages of the invention will become more fully understood from the following description of the preferred embodiment of the invention as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. [0028] FIG. 1 is an exploded, perspective view of a bird suet dispenser in accordance with the present version of the invention, illustrating the constituent components thereof. [0029] FIG. 2 is a perspective view of a bird perch for use with said bird suet dispenser in accordance with the present version of the invention. [0030] FIG. 3 is a perspective view of a bird suet dispenser assembled for use in accordance with the present version of the invention. [0031] FIG. 4 is a perspective view of a training basket in accordance with the present version of the invention. DRAWING REFERENCE NUMERALS [0000] 10 Selective Bird Suet Dispenser 12 Cylindrical Member 14 Top End 16 Bottom End 18 Sidewall 20 Interior Area 22 a Aperture 22 b Aperture 24 Indentation 26 a Spacer 26 b Spacer 28 a Pin 28 b Pin 30 a Aperture 30 b Aperture 32 Bottom Cap 34 Aperture 36 Rod 38 Opening 40 Fastener 42 Threaded Shank 44 Fastener Top 46 Top Cap 48 a Projection 48 b Projection 50 a Aperture 50 b Aperture 52 Handle 54 a First End 54 b Second End 56 a Bent Section 56 b Bent Section 58 Hood 60 Top End 62 Bottom End 64 Flange 66 Interior Area 68 Clamp 70 First End 72 Second End 74 Aperture 76 Threaded Fastener 78 Nut 80 Perch 82 Top End 84 Bottom End 86 Projection 88 Bore 90 Ring 92 Training Basket 94 Basket 96 Top End 98 Bottom End 100 Opening 102 Rim 104 a Projection 104 b Projection 106 a Aperture 106 b Aperture 108 Handle 110 a First End 110 b Second End 112 a Bent Section 112 b Bent Section 114 Bottom Sidewall 116 Washer 118 Fastener 120 Threaded Shank 122 Fastener Top DESCRIPTION OF THE PREFERRED EMBODIMENT Description [0101] Referring now to the drawings and, in particular, to FIG. 1 wherein there is illustrated a typical embodiment of the selective bird suet dispenser 10 . The present version of the invention 10 consists of a hollow, cylindrical member 12 having a top end 14 , an opposed bottom end 16 , and a continuous sidewall 18 located between said top 14 and bottom 16 ends. The top end 14 , bottom end 16 , and sidewall 18 enclose a hollow or interior space or area 20 . A first aperture 22 a is located within the sidewall 18 of the cylindrical member 12 proximate to the first end 14 thereof, and a second aperture 22 b is located within the sidewall 18 of the cylindrical member 12 proximate to the first end 14 thereof and opposite to the first aperture 22 a . Eight indentations 24 are located at the bottom end 16 of the cylindrical member 12 , said indentations 24 spaced in equidistant sequence. In this version of the invention, the cylindrical member 12 is approximately 9 inches in length between top 14 and bottom 16 ends thereof and has an outside diameter of approximately 2 inches. [0102] A first spacer 26 a is aligned for insertion into the first aperture 22 a of the cylindrical member 12 , and a second spacer 26 b is aligned for insertion into the second aperture 22 b of the cylindrical member 12 . Similarly, a first pin 28 a is aligned for insertion into the first spacer 26 a , and a second pin 28 b is aligned for insertion into the second spacer 26 b . An aperture 30 a is located within the shank of the first pin 28 a , and an aperture 30 b is located within the shank of the second pin 28 b. [0103] A bottom cap 32 , aligned for attachment to the bottom end 16 of the cylindrical member 12 , is conical in shape and possesses an aperture 34 located at the top or apex thereof. Eight rods 36 are connected at first ends thereof to the bottom cap 32 at the bottom rim thereof and extend therefrom for some distance at X angle. A space 38 is located between any two rods 36 , resulting in eight spaces 38 between the eight rods 36 . The second, unattached ends of the rods 36 form a circular pattern, commensurate with the diameter of the bottom end 16 of the cylindrical member 12 . The bottom cap 34 is attached to the cylindrical member 12 at the bottom end 16 thereof by inserting the unattached ends of the rods 36 into cooperating indentations 24 at the bottom end 16 of the cylindrical member 12 . The unattached ends of the rods 36 can be secured within cooperating indentations 24 by various means, such as welding, soldering, frictional engagement, and the like. In this version of the invention, the bottom cap 34 at the bottom rim thereof has a diameter of approximately 1.25 inches. [0104] A cylindrical fastener 40 with threaded shank 42 and round top 44 is aligned for insertion into the aperture 34 of the bottom cap 32 . When the fastener 40 is fully inserted though the aperture 34 , the fastener 40 rests upon the top 44 thereof over the aperture 34 with the threaded shank 42 thereof extending for some distance below said bottom cap 32 . [0105] A cylindrical top cap 46 is aligned for releasable attachment to the cylindrical member 12 over the top end 14 thereof. First 48 a and second 48 b opposed projections are located on opposed sides of the top cap 46 . The first projection 48 a contains an aperture 50 a , and the second projection 48 b contains an aperture 50 b. [0106] An elongate, looped handle 52 is aligned above the top cap 46 . The handle 52 consists in part of a first end 54 a , and a second opposed end 54 b . The first end 54 a terminates with a bent section 56 a that extends at X angle in relation to the longitudinal axis of the first end 54 a , and the second end 54 b terminates with a bent section 56 b that extends at X angle in relation to the longitudinal axis of the second end 54 b . The handle 52 is secured to the top cap 46 by inserting first 54 a and second ends 54 b thereof into cooperating apertures 50 a , 50 b of respective projections 48 a , 48 b of said cap 46 . First 56 a and second 56 b bent sections impinging against respective projections 48 a , 48 b prevent respective first 54 a and second 54 b ends of the handle 52 from completely sliding out of respective apertures 50 a , 50 b , thus retaining the handle 52 to the top cap 46 . [0107] Referring again to FIG. 1 , a conically-shaped hood 58 is aligned for sliding attachment to the cylindrical member 12 over the continuous sidewall 18 thereof. The hood 58 is comprised of a narrower top end 60 and an opposed, wider bottom end 62 . A circular flange 64 is located at the top end 60 and extends therefrom from approximately one-half inch. The hood 58 encloses a hollow, interior space 66 extending from the top of the flange 64 to the bottom end 62 of said hood 58 . In this version of the invention, the hood 58 traverses a distance of approximately 5.75 inches between top 60 and bottom 62 ends thereof and has a diameter of approximately 5.75 inches at the bottom end 62 thereof. The flange 64 has an inside diameter of approximately 2 inches. [0108] A clamp 68 , aligned over the flange 64 , terminates with first 70 and second 72 ends. Each end 70 , 72 of the clamp 68 has a centrally-located aperture 74 therein. A threaded fastener 76 is aligned for insertion through said apertures 74 to receive a nut 78 . When the clamp 68 is positioned over the flange 64 , the clamp 68 can be tightened by the threaded fastener 76 and nut 78 to constrict the flange 64 over the continuous sidewall 18 of the cylindrical member 12 , thus retaining the hood 58 at a particular location upon the sidewall 18 of the cylindrical member 12 . [0109] The cylindrical member 12 , caps 32 , 46 , hood 58 , and clamp 68 are comprised of material that is light weight, rigid, and impervious to corrosion and oxidation, such as various non-ferrous metals, plastics, fiberglass, composite materials, and the like. [0110] Referring to FIG. 2 , therein illustrated is a perch 80 for attachment to the bird suet dispenser 10 at the bottom cap thereof 32 . The perch 80 is cylindrical in shape and is defined by a top end 82 and an opposed bottom end 84 . A disc-shaped projection 86 is located at the top end 82 and extends therefrom for some distance. A cylindrical bore 88 is located centrally within the projection 86 and top end 82 of the perch 80 . The length and diameter of the bore 88 is commensurate with the length and diameter of the threaded shank 42 of the fastener 40 disposed within the aperture 34 of the bottom cap 32 of the cylindrical member 12 . A series of rings 90 is formed onto the exterior surface of the perch 80 , said rings 90 extending downward from the top end 82 of the perch 80 . Each ring 90 is separated by a groove of approximately 0.25 inch. In this version of the invention, the perch 80 is approximately 16-17 inches in length traversing the distance from the top end 82 to the bottom end 84 thereof and having a diameter of approximately 1.5 to 1.75 inches. The number of rings 90 can vary; in this version of the invention, 19 rings 90 are located on the perch 80 . The perch 80 is comprised of material appropriate for birds to land and perch thereon, such as various hardwoods configured with either a natural, textured surface or one that is machined smooth. [0111] In FIG. 3 , the bird suet dispenser 10 is illustrated as fully assembled and ready for use. The bottom cap 32 (shown in phantom line) is attached to the cylindrical member 12 at the bottom end 16 thereof in the manner described previously with ends of the rods 36 of the bottom cap 32 secured within cooperating indentations 24 at the bottom end 16 of the cylindrical member 12 . As a result, eight spaces or openings 38 are located between the bottom end 16 of the cylindrical member 12 and bottom rim of the bottom cap 32 . The perch 80 is attached to the underside of the bottom cap 32 by inserting the threaded shank 42 of the fastener 40 ( FIG. 1 ) through the aperture 34 of the bottom cap 32 and into the bore 88 of the perch 80 wherein said shank 42 engages the sidewall of the bore 80 . [0112] The top cap 46 is fitted over the top end 14 of the cylindrical member 12 with first 54 a and second 54 b opposed ends of the handle 52 disposed through cooperating apertures 50 a , 50 b of respective projections 48 a , 48 b of the cap 46 . The top cap 46 is secured to the top end 14 of the cylindrical member 12 by first 54 a and second 54 b opposed ends of the handle 52 extending through cooperating apertures 30 a , 30 b of respective pins 28 a , 28 b , said pins 28 a , 28 b disposed within respective spacers 26 a , 26 b located within respective apertures 22 a , 22 b of the cylindrical member 12 . With the handle 52 secured to the pins 28 a , 28 b as such, the top cap 46 can be disengaged from the top end 14 of the cylindrical member 12 by pulling the top cap 46 off the cylindrical member 12 and sliding the projections 48 a , 48 b of the top cap 46 over respective ends 54 a , 54 b of the handle 52 until top cap 46 clears the top end 14 of the cylindrical member 12 . At this point, the top cap 46 and handle 52 can be pivoted upon the pins 28 a , 28 b away from the top end 14 of the cylindrical member 12 , said movement made possible by the pins 28 a , 28 b rotating within respective spacers 26 a , 26 b disposed within respective apertures 22 a , 22 b of the cylindrical member 12 . Removing the top cap 46 and rotating the top cap 46 and handle 52 will provide unobstructed access to the interior area 20 of the cylindrical member 12 as needed to insert or replace a suet cake (not shown). When a suet cake is inserted within the interior area 20 of the cylindrical member 12 , said cake rests upon the top or apex of the bottom cap 32 , and access to said suet cake is provided by the eight spaces 38 separated by eight rods 36 of the bottom cap 32 . [0113] The hood 58 is slidingly attached to the continuous sidewall 18 of the cylindrical member 12 at various locations thereon. The clamp 68 is fitted over the flange 64 of the hood 58 and tightened as described previously to constrict the flange 64 , thereby causing the flange 64 to frictionally engage cooperating section of the sidewall 18 of the cylindrical member 12 . The hood 58 can be raised or lowered upon the cylindrical member 12 by loosening the threaded fastener 76 and nut 78 , thereby releasing clamp pressure exerted upon the flange 64 , and sliding the hood 58 up or down upon the cylindrical member 12 as desired. [0114] A training basket 92 is illustrated in FIG. 4 . The training basket 92 is designed to acclimate birds to the bird suet dispenser 10 . The training basket 92 is comprised of a basket 94 proper, said basket 94 defined in part by a top end 96 and a bottom end 98 . The basket 94 has an opening 100 at the top end thereof 96 , said opening 100 providing access to the interior of said basket 94 . A rim 102 is located at the top end of the basket 94 and contains on opposed sides thereof a first projection 104 a and a second projection 104 b . The first projection 104 a has a central aperture 106 a , and the second projection 104 b has a central aperture 106 b. [0115] In this version of the invention, the basket 94 is approximately 9 inches in length from the top end 96 to the bottom end 98 and possesses a diameter of approximately 2 inches. It 94 is comprised of hardware cloth or similar material having a weave density of approximately one-half inch. [0116] A looped handle 108 is connected to the basket 94 at the top end 96 thereof, said handle 108 comprised in part of first 110 a and second 110 b opposed ends. The first end 110 a terminates with a bent section 112 a that extends at X angle in relation to the longitudinal axis of the first end 110 a , and the second end 10 b terminates with a bent section 112 b that extends at X angle in relation to the longitudinal axis of the second end 110 b . The handle 108 is secured to the top end of the basket 94 by inserting first 110 a and second ends 110 b thereof into cooperating apertures 106 a , 106 b of respective projections 104 a , 104 b located on said rim 102 . First 112 a and second 112 b bent sections impinging against respective projections 104 a , 104 b prevent respective first 110 a and second 110 b ends of the handle 108 from completely sliding out of respective apertures 106 a , 106 b , thus retaining the handle 108 to the basket 94 . [0117] A bottom sidewall 114 is located at the bottom end 98 of the basket 94 , and a washer 116 is located centrally upon said sidewall 114 . A fastener 118 with threaded shank 120 and rounded top 122 is disposed centrally within said washer 116 . The threaded shank 120 of the fastener 118 extends for some distance below the bottom sidewall 114 of the basket 94 . The perch 80 can be attached to the underside of the bottom sidewall 114 of the basket 94 by inserting the threaded shank 120 of the fastener 118 into the bore 88 of the perch 80 wherein said shank 120 engages the sidewall of the bore 80 . [0118] During use of the training basket 92 , a perch 80 is secured at the bottom of the basket 94 proper upon the fastener as described previously, and a suet cake (not shown) is inserted into the interior of the basket 94 through the opening 100 thereof. The training basket 92 is hung upon the handle 108 from a tree branch, bird feeder post, or the like. Songbirds and woodpeckers will land and climb up or down the perch 80 , eventually pulling suet through the one-half inch openings of the basket 94 weave. This exercise will acclimate songbirds and woodpeckers to using the perch 80 and pulling suet from between a defined or enclosed area, not unlike the openings 38 between the rods 36 of the bottom cap 32 of the suet dispenser 10 . [0119] Before using the suet dispenser 10 , any suet dispensers or feeders existing in the feeding location intended for the suet dispenser 10 are removed. The suet dispenser 10 can be hung from a tree branch, bird feeder post, or the like before use of the training basket 92 , or feeding can begin with the training basket 92 , depending upon the birds' initial reaction to the suet dispenser 10 . [0120] When the opportunity has arrived for using the suet dispenser 10 , said dispenser 10 is hung from the handle 52 thereof upon a tree branch, bird feeder post, or the like in a location suitable for attracting desired birds. Initially, the hood 58 is positioned high upon the cylindrical member 12 with the flange 64 and clamp 68 proximate to the pins 28 a , 28 b so as to allow most access to the suet exposed by openings 38 of the bottom cap 32 . As songbirds and woodpeckers become acclimated with the suet dispenser 10 , climbing up and down the perch 80 , the hood 58 can be lowered until bottom 62 of hood 58 is level with top of openings 38 . Over time the hood 58 can be lowered in increments until the bottom 62 of the hood 58 is level at the junction of bottom of cap 32 and top 82 of the perch 80 . The openings 38 (and suet exposed by said openings) are mostly obscured from view, and only the songbirds and woodpeckers that have become acclimated with use of the suet dispenser 10 will continue to use the suet dispenser 10 for feeding. Pest birds, such as starlings, will avoid the suet dispenser 10 as the openings 38 and suet available through said openings 38 are mostly obscured from view, the space under the hood 58 for retrieving the suet is relatively confined, and the only way for birds to reach said openings 38 and suet made available by said openings 38 is to climb up or down the perch 80 , all of which function to keep starlings from using the suet dispenser 10 . [0121] While this version of the invention 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 embodiment has been shown and described and that all changes and modifications that come within the spirit of the version of the invention are desired to be protected. 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. CONCLUSION AND SCOPE OF INVENTION [0122] From the foregoing, it will be understood by persons skilled in the art that an improved bird suet dispenser has been provided. The invention is relatively simple and easy to manufacture, yet affords a variety of uses. While my description contains many specificities, these should not be construed as limitations on the scope of the version of the invention, but rather as an exemplification of the preferred embodiment thereof. 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. Although this invention has been described in its preferred form with a certain degree of particularity, it is understood that the present disclosure of the preferred form has been made only by way of example and numerous changes in the details of construction and combination and arrangement of parts may be resorted to without departing from the spirit and scope of the invention.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to components for use in a modular prosthetic limb wherein the effective length of the limb is adjustable to suit the particular needs of a person as the person grows and/or shrinks due to age or any other reason. [0003] 2. Description of the Related Art [0004] Sometimes, due to accidents, health problems, birth defects, etc., people 5 need to have a limb 6 amputated. The amputated limb 6 terminates in a stump 7 . In general, a socket 10 can be formed for any particular stump 7 . Those sockets 10 are well known in the art, and each socket 10 has a central axis 11 and an end 12 . [0005] Fortunately for people requiring a prosthetic limb, much advancement has been made in the field of prosthetic limbs. People now have many choices, including endoskeletal and exoskeletal prosthetic limbs. The present invention relates generally to endoskeletal prosthetic limbs. That is, limbs comprised of structural components and that may have an optional aesthetic outer shell. [0006] One conventional and exemplary prosthetic limb setup is shown in FIG. 1 . As shown, a conventional socket 10 is shown connected to a stump 7 . The socket 10 has a socket central axis 11 and has an end 12 . A three prong adapter 30 has a central axis and is shown to be connected to the socket 10 . The three prong adapter 30 is capable of being connected to the socket 10 at a rotational angle relative to the three prong adapter central axis. Hence, the three prong adapter 30 can be positioned in any rotational orientation relative to the socket 10 in the lateral direction 15 , the medial direction 16 , the anterior direction 17 and the posterior direction 18 . A pyramidal adapter 130 is shown connected to the three prong adapter 30 . A pylon 40 with a fixed receiver 41 is shown connected to the pyramidal adapter 130 . A tube clamp 43 is shown connected to the pylon 40 . The pylon 40 must be fully received within the tube clamp 43 in order to be properly connected thereto. The tube clamp 43 has a pyramidal receiver 44 that connects to a foot adapter 46 . The foot adapter 46 , in turn, connects to a prosthetic foot 49 . [0007] This and other existing prosthetic limbs generally work quite well for their intended purposes. Yet, certain drawbacks and disadvantages can be associated with existing prosthetic limbs. [0008] As a general matter, great skill is required to construct and assemble a prosthetic limb. As shown in FIG. 1 , a prosthetic limb may involve several components. Yet, the components shown only comprise one set up. Many other components exist. The practitioner first has to select desired components from a multitude of component options. Next, the practitioner needs to determine the overall length and orientation of the prosthetic limb. This step involves selecting and sizing the components so that the prosthetic limb will have a length that is identical to that of the natural limb. Additionally, the practitioner will need to account for any angular and rotational adjustments that may be necessary to properly fit the prosthetic limb to the person. [0009] Frequently, the practitioner decides to incorporate a pylon into the prosthetic limb. The practitioner can easily cut the pylon to a predetermined length using conventional methods. The cut end of the pylon can be connected to and secured in place with the clamp of an adjacent component. To accomplish this, the pylon must be fully received within the tube clamp and there is no ability to longitudinally adjust the pylon with respect to the tube clamp. One apparent drawback is that the pylon must be cut to an exact length in order for the overall length of the prosthetic limb to be correct. Yet, sometimes the practitioner miscalculates the amount of the pylon that needs to be cut off. In this case, the overall length of the prosthetic limb would be too long or too short. In the event that the overall prosthetic limb is too long, more of the pylon can be cut off to remedy the problem. Yet, if the pylon is cut too short, a new pylon will need to be cut in order to remedy the situation. Hence, the process of properly sizing the pylon can be both time consuming and wasteful. [0010] A further drawback, given that the pylon is not longitudinally adjustable with respect to the tube clamp, is that there exists an inability to finely tune a conventional prosthetic limb. That is, if the practitioner miscalculates or misconstructs the prosthetic limb even by a fraction of an inch, there is no way to overcome the shortcomings in the prosthetic limb simply by making an adjustment between the pylon and the tube clamp. In this event, absent construction of new components, the person may be forced to live with an improperly fitting prosthetic limb. [0011] A further drawback is evident upon comparison of FIGS. 2 and 3 . In FIG. 2 , the person 5 is properly fitted with a prosthetic limb. Yet, the duration of time during which the prosthetic limb will properly fit is necessarily limited. Existing prosthetic limbs may initially fit well but may not fit well after the person grows or shrinks. FIG. 3 shows such a situation. In FIG. 3 , the person has grown and the prosthetic limb has become too short. Specifically, the prosthetic limb is shorter than the natural limb by an offset length OL. While not specifically shown, it is noted that the opposite is true when a person shrinks. In such a case, the initially properly sized prosthetic limb will become too long. These problems are most prevalent in the young and the elderly, respectively. Given the inability to adjust the effective length of the prosthetic limb, the practitioner will need to replace major components of the limb or even construct an entirely new prosthetic limb as the size of the person changes. Replacing major prosthetic componentry is expensive, both in materials and in the practitioner's time, and is also inconvenient. [0012] The time, cost and inconvenience associated with replacements and adjustments of conventional prosthetic limbs may have the effect of encouraging infrequent visits to the practitioner. As the duration of time between visits increases, the prosthetic limb continues to fit worse and worse. In turn, the person may become dissatisfied with their prosthetic limb. [0013] Thus there exists a need for modular prosthetic limb components that solve these and other problems. SUMMARY OF THE INVENTION [0014] The present invention relates to a system with modular components for forming a prosthetic limb, wherein the effective length of the limb is adjustable to accommodate changing needs of a particular person. The present invention is intended for use with conventional prosthetic components. [0015] According to the present invention, several modular components are provided. One set of modular components comprise sleeve modules, or sleeves. Each sleeve has a body and two opposed ends. The ends each contain an internally threaded clamp. The sleeves can be constructed to any overall length. Spacer modules, or spacers, of several different overall lengths are also provided. Each spacer has a body and two opposed ends. Each end is externally threaded. The sleeve modules and spacer modules can be used with several additional components, such as a receiver with a clamped end or externally threaded end, and also with a pyramidal adapter with either a clamped end or externally threaded end. A practitioner can construct a custom fit prosthetic limb by selected from the several of the above-noted modular components. [0016] One advantage of the present invention is that the modules are twistable with respect to each other. Twisting the modules with respect to each other allows for the overall length of the prosthetic limb to be longitudinally adjusted and finely tuned to meet the needs of the person. The overall length of the prosthetic limb can be adjusted by amounts as small as a fraction of an inch. [0017] Another advantage of the present invention is that the modules can be selectably interchanged with modules of a different size. Hence, when the need for adjustment is greater than the adjustment capabilities provided by twisting the components with respect to each other, a module of a more proper size can be quickly and easily interchanged for the less properly sized component. Then, the overall length can again be fine tuned by twisting the components with respect to each other to achieve the desired prosthetic limb length. Multiple sleeve modules and spacer modules are provided according to the present invention. [0018] According to the present invention, even if a new component is required to make a longitudinal adjustment, the remainder of the components can remain in use. This is accomplished by swapping the module having a first length with a second module having a second length. This flexibility greatly reduces the hassle and cost associated with seeking adjustments to the length of prosthetic limbs. A person is therefore more likely to seek professional assistance at the first signs that their prosthetic limb may need readjustment. The person will have a more positive overall experience with their prosthetic limb when it remains at a proper length. [0019] The benefits of the present invention are not conferred only upon the particular person with the prosthetic limb of the present invention. Rather, the practitioner and other people in need of prosthetic care will benefit as well. By allowing adjustments to be made quicker and easier, the practitioner will have more time to see and help even more people. [0020] Other advantages, benefits, and features of the present invention will become apparent to those skilled in the art upon reading the detailed description of the invention and studying the drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0021] FIG. 1 is a perspective view of a conventional leg prosthesis setup. [0022] FIG. 2 is a perspective view of a person with the conventional leg prosthesis setup of FIG. 1 . [0023] FIG. 3 is similar to FIG. 2 , but shows the same conventional leg prosthesis setup after the person has grown. [0024] FIG. 4 is a side view of a sleeve module of the present invention. [0025] FIG. 5 is a cross-sectional view taken along line 5 - 5 in FIG. 4 . [0026] FIG. 4A is a side view of an alternative embodiment of the sleeve module of the present invention. [0027] FIG. 5A is a cross-sectional view taken along line 5 A- 5 A in FIG. 4A . [0028] FIG. 4B is a side view of an alternative embodiment of the sleeve module of the present invention. [0029] FIG. 5B is a cross-sectional view taken along line 5 B- 5 B in FIG. 4B . [0030] FIG. 4C is a side view of an alternative embodiment of the sleeve module of the present invention. [0031] FIG. 5C is a cross-sectional view taken along line 5 C- 5 C in FIG. 4C . [0032] FIG. 6 is a side view of a spacer module of the present invention. [0033] FIG. 7 is a cross-sectional view taken along line 7 - 7 in FIG. 6 . [0034] FIG. 6A is a side view of a spacer module of the present invention. [0035] FIG. 7A is a cross-sectional view taken along line 7 A- 7 A in FIG. 6A . [0036] FIG. 6B is a side view of a spacer module of the present invention. [0037] FIG. 7B is a cross-sectional view taken along line 7 B- 7 B in FIG. 6B . [0038] FIG. 6C is a side view of a spacer module of the present invention. [0039] FIG. 7C is a cross-sectional view taken along line 7 C- 7 C in FIG. 6C . [0040] FIG. 8 is a side view of a receiver adapter with an externally threaded end. [0041] FIG. 9 is a cross-sectional view taken along line 9 - 9 in FIG. 8 [0042] FIG. 10 is a side view of a receiver adapter with a clamped end. [0043] FIG. 11 is a cross-sectional view taken along line 11 - 11 in FIG. 10 . [0044] FIG. 12 is a side view of a pyramidal adapter with an externally threaded end. [0045] FIG. 13 is a cross-sectional view taken along line 13 - 13 in FIG. 12 . [0046] FIG. 14 is a side view of a pyramidal adapter with a clamped end. [0047] FIG. 15 is a cross-sectional view taken along line 15 - 15 in FIG. 14 . [0048] FIG. 16 is an exploded view of a preferred embodiment of the present invention. [0049] FIG. 17 is a side view of the preferred embodiment of the present invention shown in FIG. 16 , but showing the prosthetic components assembled. [0050] FIG. 18 is similar to FIG. 17 , but shows some of the components partially unthreaded from each other in order to change the effective length of the prosthetic limb. [0051] FIG. 19 is similar to FIG. 17 , but shows a spacer module of a second size interchanged with the spacer module of a first size. [0052] FIG. 20 is similar to FIG. 19 , but shows a sleeve module of a second size interchanged with a sleeve module of a first size. [0053] FIG. 21 shows an alternative embodiment of the present invention comprising an internally threaded three prong adapter, a receiver adapter with externally threaded end, a pyramidal adapter with externally threaded end, a sleeve module, a spacer module and a receiver adapter with clamped end. [0054] [0055] FIG. 22 shows an alternative embodiment of the present invention comprising an internally threaded three prong adapter, a receiver adapter with externally threaded end, a pyramidal adapter with clamped end, a spacer module, a sleeve module and a receiver adapter with an externally threaded end. [0056] FIG. 23 shows an alternative embodiment of the present invention comprising an externally threaded three prong adapter, a sleeve module and a receiver adapter with externally threaded end. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0057] While the invention will be described in connection with several preferred embodiments, it will be understood that it is not intended to limit the invention to those embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims. [0058] Turning now to FIGS. 4 and 5 , a first module 50 is provided. According to one aspect of the present invention, the module 50 can be a sleeve 60 or sleeve module. The sleeve 60 is preferably made of Titanium allow. However, other materials can be used without departing from the broad aspects of the present invention. The sleeve 60 has a first end 65 . The sleeve 60 has a clamp 66 on the exterior surface of the first end 65 and is threaded with threads 67 on the interior surface of the first end. Opposed to the first end 65 is a second end 70 . The second end 70 is similar to the first end 65 , and comprises a clamp 71 in its exterior surface and is threaded with threads 72 on its interior surface. A body 75 exists between the first end 65 and the second end 70 . The sleeve 60 has an overall length Gamma. [0059] An alternative embodiment of the first module is shown in FIGS. 4A and 5A , and the alternative is shown with reference number 60 A. Sleeve 60 A has a first end 65 A. The sleeve 60 A has a clamp 66 A on the exterior surface of the first end 65 A and is threaded with threads 67 A on the interior surface of the first end. Opposed to the first end 65 A is a second end 70 A. The second end 70 A is similar to the first end 65 A, and comprises a clamp 71 A in its exterior surface and is threaded with threads 72 A on its interior surface. A body 75 A exists between the first end 65 A and the second end 70 A. The sleeve 60 A has an overall length GammaA. [0060] A further alternative embodiment of the first module is shown in FIGS. 4B and 5B , and the alternative embodiment is shown with reference numeral 60 B. Sleeve 60 B has a first end 65 B. The sleeve 60 B has a clamp 66 B on the exterior surface of the first end 65 B and is threaded with threads 67 B on the interior surface of the first end. Opposed to the first end 65 B is a second end 70 B. The second end 70 B is similar to the first end 65 B, and comprises a clamp 71 B in its exterior surface and is threaded with threads 72 B on its interior surface. A body 75 B exists between the first end 65 B and the second end 70 B. The sleeve 60 B has an overall length GammaB. [0061] A still further alternative embodiment of the first module is shown in FIGS. 4C and 5C , and the alternative embodiment is shown with reference numeral 60 C. Sleeve 60 C has a first end 65 C. The sleeve 60 C has a clamp 66 C on the exterior surface of the first end 65 C and is threaded with threads 67 C on the interior surface of the first end. Opposed to the first end 65 C is a second end 70 C. The second end 70 C is similar to the first end 65 C, and comprises a clamp 71 C in its exterior surface and is threaded with threads 72 C on its interior surface. A body 75 C exists between the first end 65 C and the second end 70 C. The sleeve 60 C has an overall length GammaC. [0062] Even though four embodiments of the sleeve module 60 are described and shown, it is apparent that the present invention is not limited to those embodiments. Rather, sleeve modules of other lengths are also considered to be within the scope of the present invention. [0063] Turning now to FIGS. 6 and 7 , a second module 50 is provided. The second module is a spacer 80 or spacer module. The spacer is preferably made of Titanium allow. However, it may be made from other materials without departing from the broad aspects of the present invention. The spacer 80 has a first end 85 . The first end 85 has an external surface 86 that is threaded with threads 87 . Opposed to the first end 85 is a second end 90 . The second end 90 has an external surface 91 that is threaded with threads 92 . A body 95 is provided and is located between the first and second ends 85 and 90 , respectively. The body 95 has a length. The spacer 80 has an overall length Epsilon. [0064] An alternative embodiment of the second module is shown in FIGS. 6A and 7A , and the alternative embodiment is shown with reference numeral 80 A. Spacer 80 A has a first end 85 A. The first end 85 A has an external surface 86 A that is threaded with threads 87 A. Opposed to the first end 85 A is a second end 90 A. The second end 90 A has an external surface 91 A that is threaded with threads 92 A. A body 95 A is provided and is located between the first and second ends 85 A and 90 A, respectively. The body 95 A has a length. The spacer 80 A has an overall length EpsilonA. [0065] A further alternative embodiment of the second module is shown in FIGS. 6B and 7B , and the alternative embodiment is shown with reference numeral 80 B. Spacer 80 B has a first end 85 B. The first end 85 B has an external surface 86 B that is threaded with threads 87 B. Opposed to the first end 85 B is a second end 90 B. The second end 90 B has an external surface 91 B that is threaded with threads 92 B. A body 95 B is provided and is located between the first and second ends 85 B and 90 B, respectively. The body 95 B has a length. The spacer 80 B has an overall length EpsilonB. [0066] A still further alternative embodiment of the second module is shown in FIGS. 6C and 7C , and the alternative embodiment is shown with reference numeral 80 C. Spacer 80 C has a first end 85 C. The first end 85 C has an external surface 86 C that is threaded with threads 87 C. Opposed to the first end 85 C is a second end 90 C. The second end 90 C has an external surface 91 C that is threaded with threads 92 C. A body 95 C is provided and is located between the first and second ends 85 C and 90 C, respectively. The body 95 C has a length. The spacer 80 C has an overall length EpsilonC. [0067] A receiver adapter with externally threaded end 100 is provided, and is shown in FIGS. 8 and 9 . The receiver adapter 100 is preferably made of Titanium allow. However, other materials can alternatively be used. The receiver adapter 100 has a receiver 101 at a first end. At the opposed end 103 is an external surface that is threaded with threads 104 . The receiver 101 is adapted to receive a conventional pyramidal object. The receiver 101 has four sides. Each side has a threaded hole therethrough for receiving a screw. The screws can be selectively twisted into the respective holes to clamp onto a pyramidal object received within the receiver 101 . [0068] A receiver adapter with clamped end 110 is provided and is shown in FIGS. 10 and 11 . The receiver adapter 110 is preferably made of Titanium allow. However, other material may alternatively be used. The receiver adapter 110 has a receiver 111 at a first end. At the opposed end 113 is a clamp 114 , which is located on the external surface of end 113 . The interior surface of the clamped end 113 is threaded with threads. The receiver 111 is adapted to receive a conventional pyramidal object. The receiver 111 has four sides. Each side has a threaded hole therethrough for receiving a screw. The screws can be selectively twisted into the respective holes to clamp onto a pyramidal object that is received within the receiver 111 . [0069] Turning now to FIGS. 12 and 13 , a pyramidal adapter with externally threaded end 120 is provided. The pyramidal adapter 120 is preferably made of Titanium allow. However, other materials may alternatively be used. The pyramidal adapter 120 has a first end comprising a pyramid 121 . The pyramid 121 is preferably positioned centrally upon a dome 122 . Opposed to the pyramid 121 is an externally threaded end 123 having threads 124 on the external surface. [0070] A further prosthetic component is shown in FIGS. 14 and 15 . In this regard, a pyramidal adapter with clamped end 130 is provided. The pyramidal adapter 130 is preferably made of Titanium allow. However, other materials may alternatively be used. The pyramidal adapter 130 has a first end comprising a pyramid 131 . The pyramid 131 is preferably positioned centrally upon a dome 132 . Opposed to the pyramid 131 is a clamped end 133 . The clamped end 133 comprises a clamp 134 on the external surface, and has an internal surface that is threaded with threads 135 . [0071] Applicant notes that components 100 , 110 , 120 and 130 are provided for illustrative purposes, and the principles of the present invention may extend beyond these preferred embodiments. [0072] The components shown and described herein can be interchangeably and adjustably connected together to create a prosthetic limb having the desired length and orientation. Several examples of how the components may be interchanged are provided. Yet, it is understood that the present invention is not limited to those embodiments. [0073] One preferred set up comprising components of the present invention is shown in an exploded view in FIG. 16 . As shown, a stump 7 with a conventional socket 10 is provided. A three prong adapter 30 having prongs 31 and an internally threaded end 32 and is adapted to be connected to the socket 10 in a conventional manner. A spacer module 80 is provided, and the first end 85 is positioned for being screwed into the internally threaded end 32 of the three prong adapter. Further, a sleeve module 60 is provided such that the first end 65 can be screwed onto the second end 90 of the spacer module 80 . A receiver adapter with externally threaded end 100 is shown next, and is positioned such that the externally threaded end 103 can be threadably received within the second end 70 of the sleeve module 60 . The receiver 101 is then able to clamp onto a foot adapter 46 with a pyramidal end 47 . The foot adapter 46 , in turn is then connected to the foot 49 . It is shown that the bodies 75 and 90 of the sleeve module 60 and the spacer module 80 , respectively, are alignable upon a single axis that is generally parallel to a longitudinal axis of the prosthetic limb. These components, due to being threadably connected, are capable of being longitudinally adjusted relative to each other by twisting them in opposite directions about the single axis. [0074] FIG. 17 shows a prosthetic limb comprising the components shown in FIG. 16 . The components 30 , 80 , 60 and 100 are threadably connected to their respective adjacent components. Upon a closer look, it is seen that spacer 80 is threaded all the way into the internally threaded end 32 of the three prong adapter 30 , such that the spacer and three prong adapter are fully engaged. Likewise, the sleeve module 60 fully receives the opposite end of the spacer 80 . However, the threaded end of the receiver adapter 100 is not threaded completely into the sleeve. Rather, the receiver adapter 100 is unthreaded approximately one revolution from the sleeve 60 . Selectably threading and unthreading a component changes the overall length of the prosthetic component. In this preferred embodiment, the prosthetic limb has a selected effective length L 1 . [0075] Turning now to one intended use of the preferred invention, it is noted that in FIG. 17 , the effective length L 1 is the necessary length of the prosthetic limb such that the prosthetic limb will have a length equal to the natural limb. In this example, this fine tune adjustment was accomplished when the practitioner twisted the receiver adapter 100 one revolution out of full reception within the sleeve 60 . It is noted that one full revolution is provided for illustrative purposes only. In practice, the components can be twisted with respect to each other by any fraction or multiple of one revolution. [0076] Principles of the present invention are further illustrated by way of comparison between FIGS. 17 and 18 . The prosthetic limbs shown in FIGS. 17 and 18 both comprise identical components. However, the effective length L 2 of the prosthetic limb shown in FIG. 18 is longer than the effective length L 1 of the prosthetic limb shown in FIG. 17 . This change if effective length is caused by selectably twisting the components out of full engagement with selected adjactent components. In particular, the first end of the spacer 80 is unthreaded approximately two revolutions out of full engagement with the three prong adapter 30 . Further, the second end of the spacer 60 is unthreaded approximately one revolution out of the sleeve 80 . This method of adjustment of the effective length of the prosthetic limb is useful when the overall required adjustment is relatively small. [0077] Further, in accordance with the principles of the present invention, is the ability to swap modules 50 of one size with modules of a different size. Such principles are apparent upon comparison of FIGS. 18 and 19 . One structural difference between the prosthetic limbs shown in the two figures is that the spacer 80 shown in FIG. 18 is replaced with spacer 80 A in FIG. 19 . Given that spacer 80 A has a longer length Epsilon A than spacer 80 having length Epsilon, it is shown that the effective length L 3 of the prosthetic limb shown in FIG. 19 is greater than the effective length L 2 of the prosthetic limb shown in FIG. 18 . Yet, no customizing of individual components is necessary to accomplish this change. Further, this change is accomplished merely by swapping a single component with another component. The effective length L 3 of the prosthetic limb shown in FIG. 19 can be fine tuned be twisting some components as necessary either further into or out of their respective adjacent components. [0078] FIG. 20 further demonstrates the flexibility of the present invention. FIG. 20 is similar to FIG. 19 , but the sleeve module 60 has been replaced with larger sleeve module 60 A. The effective length L 4 of the prosthetic limb is increased replacing the first sleeve module 60 with the larger sleeve module 60 A. Hence, it is apparent that the prosthetic limb can interchangeably be made longer as a person grows. Applicant notes that the overall effective length of the prosthetic limb can continue to increase if sleeves 60 B or 60 C and spacers 80 B and 80 C are interchanged for sleeve 60 or 60 A and spacer 80 or 80 A, respectively. It is noted that the practitioner can achieve the opposite effect by replacing a longer component with a relatively smaller like kind component. [0079] FIGS. 21-23 further exemplify the principles of the present invention. In FIG. 20 , a three prong adapter 30 is shown for connecting to the socket 10 . A receiver adapter with an externally threaded end 100 is provided for connecting to the three prong adapter 30 . Next, a pyramidal adapter with an externally threaded end 120 is provided for being angularly adjustably connected to the receiver adapter 120 . A sleeve module 60 is provided for connecting to the pyramidal adapter 120 . A spacer module 80 is provided for being connected to the sleeve module 60 . A receiver adapter with externally threaded end 110 is also provided. The receiver adapter 110 can be connected to a foot adapter 46 , which in turn is connectable to a prosthetic foot 49 . The receiver adapter 100 and the pyramidal adapter 120 can be angularly adjustably connected to each other. Further, given that these components are threadably connected to their adjacent components, the receiver adapter 100 and the pyramidal adapter 120 can be connected into any rotational alignment with respect to those adjacent components. [0080] FIG. 22 shows yet another prosthetic limb configuration employing the principles of the present invention. In this preferred embodiment, the components are in the following configuration: a three prong adapter 30 connectable to a receiver adapter with an externally threaded end 100 , which is connectable to a pyramidal adapter with clamped end 130 , which is connectable to a spacer module 80 , which is connectable to a spacer module 60 , which is connectable to a receiver adapter with an externally threaded end 100 , which is connectable to a foot adapter 46 that is connected to a prosthetic foot 49 . [0081] Still another preferred embodiment is shown in FIG. 23 . In this figure, the prosthetic limb has the following configuration: a three prong adapter 35 with external threads 37 , the three prong adapter 35 being connectable to a relatively large sleeve module 60 C, which is connectable to a receiver adapter with externally threaded end 100 , which is connectable to a foot adapter 46 that is connected to a foot. FIG. 23 illustrates the ability to construct a fully adjustable and fine tunable prosthetic limb with only a limited number of components. [0082] It is apparent that the number of possible configurations embodying the principles of the present invention is numerous, and that it is impractical to show in detail all of the numerous possible configurations. Rather, several preferred embodiments have been provided and serve as to demonstrate the principles of the present invention. [0083] Turning now to the setup and use of the present invention, it is noted that the modules 50 of the present invention are capable of being used with other prosthetic components not shown herein. For example, angular and offset alignment devices presently exist, and can readily be incorporated into a system comprising the principles of the present invention. [0084] In order to construct a prosthetic limb, the practitioner will first need to observe the socket 10 in order to determine the shape and orientation of the end 12 of the socket. In some cases, the prosthetic limb will need to incorporate angular and/or offset alignment devices. If so, the proper devices will be selected first. Next, a means for connecting the prosthetic limb to the socket 10 will be selected and the prosthetic foot 49 will be selected. Given that the practitioner knows the overall effective length required, and given that the practitioner knows the length of the selected components, the practitioner will be able to estimate the necessary length of the remaining components yet to be selected. The practitioner then can select modules 50 as necessary to interconnect with the previously selected components. [0085] Next, the practitioner assembles the selected components. If the effective length of the assembled prosthetic limb is not close to the length of the natural limb, the modules 50 can be swapped with modules of a more appropriate length. After the practitioner determines and incorporates the properly sized components, the practitioner then fine tunes the effective length of the prosthetic limb by selectably twisting the components towards or away from full engagement with the respective adjacent components. The clamps can then be tightened to lock the prosthetic components in place. [0086] It is noted that offset alignment devices and angled alignment devices may need to be in a particular rotational orientation relative to a longitudinal axis of the prosthetic limb. Due to the rotational and threaded connectivity of the components provided, such a situation is not an obstacle. Rather, any offset alignment devices and angled alignment devices that are incorporated into the prosthetic limb are simply rotated or twisted with respect to their adjacent components until the desired rotational orientation is achieved. [0087] The effective length of the prosthetic limb can be easily modified by simply loosening a clamp, and then either threading a first component either further towards or away from full engagement with its adjacent component, as appropriate. Yet, at some point, the required adjustment will exceed the adjustment capabilities provided by twisting the components relative to each other. In this case, a module 50 of a first size can be easily swapped with a module of a second size to obtain the proper effective length of the prosthetic limb. [0088] It is noted that the modular aspects of the present invention allows the practitioner to make a custom fit prosthetic limb without the need for individually made custom components. [0089] Thus it is apparent that there has been provided, in accordance with the invention, modular prosthetic limb components that fully satisfy the objects, aims and advantages as set forth above. While the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications, and variations as fall within the spirit and broad scope of the appended claims.

1a

[0001] This application is a continuation application of co-pending U.S. Ser. No. 11/434,369 filed May 15, 2006, the priority of which is hereby claimed. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention generally relates to liquid bird feeders, and in particular to such bird feeders which provide for inverted filling while minimizing residual liquid spillage. [0004] 2. Description of the Prior Art [0005] Liquid nectar bird feeders are used for specifically attracting hummingbirds in the same manner as seed feeders are used to attract other birds. Some may consider liquid nectar feeders to be less convenient however, because of the liquid auto-feed structure. Filling liquid feeders commonly requires inversion of the feeder and certain liquid spillage from this action. [0006] It is therefore desirable to have a liquid nectar feeder which minimizes liquid spillage during filling. SUMMARY OF THE INVENTION [0007] One embodiment of the present invention provides a liquid bird feeder, comprising a liquid container having a bottom opening, a liquid tray adapted to attach to the liquid container and adapted to immerse the bottom opening in liquid, wherein the liquid tray includes a bottom port passing through the liquid tray and vertically aligned with the bottom opening, and a valve mechanism adapted to selectively couple the bottom port of the liquid tray to the bottom opening for filling purposes, or to close the bottom port and couple the bottom opening to the liquid tray for supplying liquid from the liquid container to the liquid tray. [0008] The liquid tray may include a concave bottom surface located adjacent to the bottom port and adapted to act as a funnel or collector for filling the liquid container through the bottom port. The bird feeder may further comprise a valve actuator handle extending through the bottom port. The valve actuator handle may be located within the concave bottom surface of the liquid tray. The concave bottom surface may surround the bottom port. [0009] The liquid tray may include a top cover enclosing the liquid tray and adapted to avoid liquid spillage from the liquid tray during inversion of the bird feeder. The liquid tray top cover may include one or more feeding ports which extend below the bottom opening when the bird feeder is in an upright position, and thus below a normal liquid level in the liquid tray. The top cover may enclose sufficient volume to keep the bird feeder ports above a normal liquid level when the bird feeder is inverted. [0010] In another embodiment, the present invention provides a liquid bird feeder, comprising a liquid container having a bottom opening, a liquid tray adapted to attach to the liquid container and adapted to immerse the bottom opening in liquid, a cylindrical collar forming a bottom port of the liquid tray and extending through the liquid tray and the bottom opening, and a stopper adapted for closing the cylindrical collar from beneath the liquid tray. The cylindrical collar is adapted to allow filling of the liquid container through the bottom port by removal of the stopper and locating the feeder in an inverted position, and further adapted to allow liquid flow from the liquid container into the liquid tray with the stopper closing the cylindrical collar and the feeder located in an upright position. [0011] The bottom opening may be larger than an outer diameter of the cylindrical collar. The liquid container may include a cylindrical extension forming the bottom opening and extending downwardly around a top end of the cylindrical collar. [0012] The liquid tray may include a concave bottom surface located adjacent to the bottom port and adapted to act as a funnel or collector for filling the liquid container through the bottom port. The bird feeder may further comprise a stopper grip extending through the bottom port. The stopper grip may be located within the concave bottom surface of the liquid tray. The concave bottom surface may surround the bottom port. [0013] The liquid tray may include a top cover enclosing the liquid tray and adapted to avoid spillage from the liquid tray during inversion of the bird feeder. The liquid tray top cover may include one or more feeding ports which extend below the bottom opening of the liquid container when the bird feeder is in an upright position, and thus below a normal liquid level in the liquid tray. The top cover may enclose sufficient volume to keep the bird feeder ports above a normal liquid level when the bird feeder is inverted. BRIEF DESCRIPTION OF THE DRAWINGS [0014] The present invention is illustratively shown and described in reference to the accompanying drawings, in which: [0015] FIG. 1 is a perspective view of a liquid bird feeder constructed in accordance with one embodiment of the present invention. [0016] FIG. 2 is a central cross sectional view of the bird feeder of FIG. 1 . [0017] FIG. 3 is an exploded view of the bird feeder of FIGS. 1 and 2 . [0018] FIG. 4 is a bottom view of the bird feeder of FIGS. 1-3 . [0019] FIG. 5 is a similar bottom view of the bird feeder of FIGS. 1-3 with a component being located in another operative position. [0020] FIG. 6 is a partial cross sectional view of an alternative embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0021] In describing preferred embodiments of the present invention illustrated in the drawings, specific terminology is employed for the sake of clarity. However, the invention is not intended to be limited to the specific terminology so selected, and it is to be understood that each specific element includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. [0022] FIG. 1 shows a liquid bird feeder 10 , which generally includes a liquid container 12 and a liquid tray 14 . Tray 14 further includes a multiplicity of flower-like bird feeding ports 16 . [0023] FIG. 2 shows a centrally located, cross section of bird feeder 10 including the same liquid container 12 , liquid tray 14 , and feeding ports 16 . FIG. 2 further shows liquid container 12 to have a bottom opening 18 formed by a cylindrical extension 20 . Container 12 is also shown to be otherwise closed. It should be noted that bottom opening 18 extends below an upper edge 22 of liquid tray 14 . This allows the gradual feeding of liquid from liquid container 12 into tray 14 when the liquid level within tray 14 is below the bottom opening 18 . Whenever the liquid level in tray 14 is above bottom opening 18 , a vacuum created above the liquid located within liquid container 12 prevents further flow into tray 14 . This is a normal liquid level for enabling bird feeding. [0024] Liquid tray 14 includes bottom port 30 which passes through liquid tray 14 and is vertically aligned with bottom opening 18 . Port 30 is closed by a valve 32 , which is constructed to either allow the filling of liquid container 12 when feeder 10 is in an inverted position or to allow the normal flow of liquid into tray 14 when feeder is in an upright position. Valve 32 closes port 30 by means of a seal 34 . [0025] Also shown in FIG. 2 is a cover 38 for liquid tray 14 that is located between liquid container 12 and tray 14 . Feeding ports 16 are mounted in cover 38 and are shown to have lower ends 16 a which extend below bottom opening 18 and thus below the normal liquid level which would be maintained at or about bottom opening 18 . When feeder 10 is inverted for filling, cover 38 has sufficient volume to contain the liquid from tray 14 and thus spillage is prevented. In this inverted position, the ends 16 a normally extend above the normal liquid level to be expected. Optionally, the top 38 a of cover 38 may include a seal of any suitable nature with which container 12 or top 38 a may be sealed during construction of feeder 10 to prevent any seepage. [0026] FIG. 3 shows an exploded view of bird feeder 10 . Liquid tray 14 also includes a cylindrical collar 40 , which forms the bottom port 30 ( FIG. 2 ). Cylindrical collar 40 includes female thread 42 adapted to mate with a male thread 44 located on cylindrical extension 20 . When tray 14 is attached to container 12 in this manner, tray cover 38 is squeezed therebetween. Cylindrical collar 40 also includes a port 46 located in its side wall. Valve 32 is also shown in FIG. 3 with a cylindrical construction 47 having lateral port 49 . In reference to FIG. 2 , when valve 32 closes port 30 , the alignment of ports 46 and 49 allows liquid to flow from liquid container 12 into liquid tray 14 . [0027] FIGS. 4 and 5 show bottom views of liquid tray 14 which differ in that valve 32 is located in respective opened and closed positions. Tray 14 is shown to include a concave depression 52 which is adapted to work as a funnel for liquid being poured into feeder 10 . Concave depression 52 is shown to fully contain a grip or handle 53 for valve 32 . In the open position of FIG. 4 , a space 54 is provided between seal 34 and tray 14 . This allows liquid poured into depression 52 to flow into liquid container 12 . In FIG. 5 , valve 32 is shown in a closed position with no similar space shown adjacent to seal 34 . The variation in the vertical position between tray 14 and valve 32 with the rotation of valve 32 can be caused by any suitable thread arrangement, such as thread follower 51 ( FIG. 3 ) on valve 32 and a corresponding thread or channel (not shown) on the inside surface of cylindrical extension 40 . Any suitable valve design may be used. Functionally, container 12 is connected to tray 14 when valve 32 is closed, and container 12 is connected to port 30 and not tray 14 when valve 32 is open. [0028] FIG. 6 shows a cross sectional view of an alternate valve or stopper 60 , being used to close the bottom of port 30 a. Liquid tray 14 a is shown to include an additional cylindrical collar 62 , which is aligned with and extends into bottom opening 18 a of cylindrical extension 20 a. The outer diameter 62 a of cylindrical collar 62 is smaller than the inner diameter 20 b of cylindrical extension 20 a and bottom opening 18 a. [0029] Stopper 60 is intended for complete removal from tray 14 a when liquid feed is poured through bottom port 30 a of tray 14 a. Thus, liquid feed flows directly through cylindrical extension 20 a and it does not enter liquid tray 14 a. Tray 14 a includes a concave depression 64 to act as a funnel. Thus, when stopper 60 closes port 30 a, as shown in FIG. 6 , and the feeder is turned upright, liquid is allowed to flow through extension 20 a, around the outside of cylindrical collar 62 and through port 46 a into tray 14 a. Any suitable means may be used to secure stopper 60 in port 30 a against a washer 34 a, including a threaded engagement sufficient to maintain a liquid seal. [0030] Thus, the present invention provides a liquid bird feeder which is well adapted for refilling, while minimizing spillage of residual liquid feed. [0031] It is now apparent to those skilled in the art that other embodiments, improvements, details, and uses can be made consistent with the letter and spirit of the foregoing disclosure and within the scope of this patent, which is limited only by the following claims, construed in accordance with the patent law, including the doctrine of equivalents.

1a

FIELD OF THE INVENTION [0001] The present invention is concerned with enhancing healing of injured tissue by administering naturally occurring and/or modified Clostridium neurotoxins, and/or those neurotoxins free of complexing proteins. Such neurotoxins can be employed to enhance wound healing (including the prevention of scar formation) and find applicability in the area of ophthalmology, e.g. in treatment of injured corneal tissue, for example by closing inflamed eyes. Their diagnostic usage and medicaments for use therein are also disclosed. BACKGROUND OF THE INVENTION [0002] The present invention is directed to enhancement of healing of injured surface or superficial tissue using naturally occurring and/or modified neurotoxins. Clostridium botulinum neurotoxins from serotypes A, B, C 1 , D, E, F and G, and Clostridial neurotoxins free of the complexing proteins naturally occurring in Clostridial neurotoxins may be used to facilitate or enhance such healing. Clostridial neurotoxins which exhibit short duration of action, such as type E or F, may be indicated in cases where a relatively brief period of muscle paralysis is desired, such as in the treatment of wounds which heal rapidly. Clostridial neurotoxins with shorter biological persistence may exhibit reduced antibody formation, thereby maintaining the therapeutic efficacy of Clostridial neurotoxins in wound healing. [0003] Wound healing after injury or surgical intervention may be adversely affected by tension on wound margins. Reflex muscular contractions, which may occur especially with lessening analgesia, can displace any as yet unhealed wound margins. This displacement may facilitate the entry of pathogens and, at worst, secondary healing therapy is required. In the case of secondary healing the operation wound has to be opened again and cleansed several times daily. Necrotic tissue must be removed regularly (debridement). Secondary healing takes considerably longer than primary healing: it is not only labor intensive and incurs additional cost, but also results in cosmetically unsatisfactory large scars. It can also lead to adhesions in muscles that have not been sutured together, which after healing may lead to painful random contractions of muscles scarred by connective tissue. Usually an attempt is made to counteract this by immobilizing the injured area. This may be done by, for example, applying a splint, special bandages or other devices for fixation and positioning. However, these currently used methods are in many cases inadequate and/or inconvenient and often cannot be used, especially after operation or injury to the abdomen. [0004] The anaerobic, gram positive bacterium Clostridium botulinum produces a potent polypeptide neurotoxin, botulinum toxin, which causes a neuroparalytic disease in humans and animals referred to as botulism. The spores of Clostridium botulinum are found in soil and can grow in improperly sterilized and sealed food containers of home based canneries, which are the cause of many of the cases of botulism. The effects of botulism typically appear 18 to 36 hours after eating the foodstuffs contaminated with a Clostridium botulinum . The botulinum toxin can pass unattenuated through the lining of the gut because it is protected from the attack of pancreatic proteases by complexing proteins such as hemagglutinins and a nontoxic, nonhemagglutinating protein. The pure neurotoxin attacks peripheral motor neurons upon resorption from the gut. Symptoms of botulinum toxin intoxication can progress from difficulty walking, swallowing and speaking to paralysis of the respiratory muscles and death. [0005] Botulinum toxin is the most lethal natural biological agent known to man. About 5-6 picograms of botulinum toxin (purified neurotoxin) serotype A (BoNT/A) given parenterally is one MLD (minimum lethal dose) in mice. One unit (U) of botulinum toxin is defined as the MLD upon intraperitoneal injection into female Swiss Webster mice weighing 18-20 grams each. Seven immunologically distinct botulinum toxin types have been characterized, these being respectively botulinum neurotoxin serotypes A, B, C 1 , D, E, F and G, each of which is distinguished by neutralization with serotype-specific antibodies. The different serotypes of botulinum toxin vary in the animal species that they affect and in the severity and duration of the paralysis they evoke. For example, it has been determined that BoNT/A is 500 times more potent, as measured by the rate of paralysis produced in the rat, than is botulinum toxin serotype B (BoNT/B). Additionally, BoNT/B has been determined to be non-toxic in primates at a dose of 480 U/kg which is about 12 times the primate MLD for BoNT/A. In contrast, serotype A has a ten times longer duration of paralysis than type E when injected in mice. BoNT/C 1 acts preferentially in birds. [0006] Botulinum toxins have been used in clinical settings for the treatment of neuromuscular disorders characterized by hyperactive skeletal muscles due to a pathological overactivity of peripheral nerves. BoNT/A has been approved by the U.S. Food and Drug Administration for the treatment of blepharospasm, strabismus and hemifacial spasm. Non-serotype A botulinum toxin serotypes apparently have a lower potency and/or a shorter duration of activity as compared to BoNT/A. Clinical effects of peripheral intramuscular BoNT/A are usually seen within one week of injection. The typical duration of symptomatic relief from a single intramuscular injection of BoNT/A averages about three months. [0007] All the botulinum toxin serotypes apparently inhibit release of the neurotransmitter acetylcholine at the neuromuscular junction; however, they do so by affecting different neurosecretory proteins and cleaving these proteins at different sites. For example, both botulinum serotypes A and E cleave the 25 kiloDalton (kD) synaptosomal associated protein (SNAP-25); however, each toxin cleaves at a unique site within this protein. Botulinum toxin serotype C, (BoNT/C 1 ) has been shown to cleave both syntaxin and SNAP-25. BoNT/B, D, F and G act on vesicle-associate protein (VAMP, also called synaptobrevin), with each serotype cleaving the protein at a different site. These mechanistic differences may affect the relative potency and/or duration of action of the various botulinum toxin serotypes. [0008] Regardless of serotype, the molecular mechanism of toxin intoxication appears to be similar and to involve several steps or stages. The intraneuronal targets of the Clostridial toxins universally participate in the process of neurotransmitter release. In the first step of the process, the toxin binds to the presynaptic membrane of the target neuron through a specific interaction between the H chain and a cell surface receptor; the receptor is thought to be different for each serotype of botulinum toxin. The carboxyl end segment of the H chain, H C , appears to be important for targeting of the toxin to the cell surface. [0009] In the second step, the toxin is engulfed by the cell through receptor-mediated endocytosis, and an endosome containing the toxin is formed. In the next step the toxin escapes the endosome into the cytoplasm of the cell. This step is thought to be mediated by the amino end segment of the H chain, H N , which triggers a conformational change of the toxin in response to a pH of about 5.5 or lower. Endosomes are known to possess a proton pump which decreases intra-endosomal pH. The conformational shift exposes hydrophobic residues in the toxin, which permits the toxin to embed itself in the endosomal membrane. The toxin then translocates through the endosomal membrane into the cytosol. [0010] The next step of the mechanism of botulinum toxin activity involves reduction of the disulfide bond joining the H and L chains. The entire toxic activity of botulinum toxins is contained in the L chain of the holotoxin which has to be separated from the heavy chain to achieve its full activity; the L chain is a zinc (Zn ++ ) endopeptidase which, in the last step, selectively cleaves proteins essential for recognition and docking of neurotransmitter-containing vesicles to the cytoplasmic surface of the plasma membrane, and fusion of the vesicles with the plasma membrane. [0011] The molecular weight of the botulinum neurotoxin protein molecule, for all seven of the known botulinum toxin serotypes, is about 150 kD. However, the botulinum toxins are released by Clostridial organisms as complexes comprising the 150 kD botulinum toxin protein molecule along with associated haemagglutinins and non-toxin proteins. Thus, the BoNT/A complex can be produced by Clostridium bacteria as 900 kD, 500 kD and 300 kD forms. BoNT/B and C, are apparently produced as only a 500 kD complex. BoNT/D is produced as both 300 kD and 500 kD complexes. Finally, BoNT/E and F are produced as only approximately 300 kD complexes. The complexes (i.e. molecular weight greater than about 150 kD) are believed to contain non-toxin hemagglutinins and a non-toxin, non-toxic non-hemagglutinin protein. [0012] Repeated injection of the complex is followed in a considerable number of patients by formation of specific neutralizing antibodies which are also directed against the neurotoxin. The direct consequence is that antibody-positive patients no longer respond to the complex. However, they might be treated with other toxin types, although not all of them are approved for therapy. When the patient has been tested with all the toxin types and has formed antibodies against them, further administration of a botulinum toxin complex (irrespective of the type) no longer provides a remedy. It must be taken into account in this connection that each dose of complex contributes to increasing the antibody titer until further administration of the complex no longer makes sense because no effect is achieved. [0013] The formation of specific antibodies may be facilitated by the non-toxin constituents of the complex. The neurotoxin, fixed in the complex, remains in the tissue for a long period and may activate immune cells which migrate into the tissue to form antibodies. The long residence time does not result in increased uptake by the target cells, however, since poisoned target cells are no longer able to take up toxin. The neurotoxin which slowly dissociates out of the complex thus now has only immunological activity. Moreover, the non-toxin proteins present in the complex may intensify an immune response. Hemagglutinins are lectins, that is to say proteins which are distinguished by a high affinity for certain sugars. Because of their binding to sugar structures, lectins have immuno-stimulating effects. Thus, it has been possible to show that the lectins concanavalin A, phytohemagglutinin and pokeweed mitogen activate T and B lymphocytes. The hemagglutinins of the botulinum toxin complexes, which likewise bind to membrane-associated sugars, are thus able in a similar way to act as immunoadjuvants and contribute to antibody formation and thus to failure of the therapy. [0014] An object of the present invention was therefore to develop an alternative mode of treatment for wound healing and preventing scar formation. In particular, the inventor proposes a suitable active ingredient with which patients may effectively be treated without the formation of neutralizing antibodies and with which patients who have already formed neutralizing antibodies may be treated. [0015] In vitro studies have indicated that botulinum toxins inhibit potassium cation induced release of both acetylcholine and norepinephrine from primary cell cultures of brainstem tissue. Additionally, it has been reported that botulinum toxins inhibit the evoked release of both glycine and glutamate in primary cultures of spinal cord neurons and that in brain synaptosome preparations botulinum toxin inhibits the release of each of the neurotransmitters acetylcholine, dopamine, norepinephrine, CGRP and glutamate. [0016] Clostridium neurotoxin may be obtained by establishing and growing cultures of Clostridium botulinum in a fermenter and then harvesting and purifying the fermented mixture in accordance with known procedures. All the botulinum toxin types are initially synthesized as inactive single chain proteins which must be cleaved or nicked by proteases to become neuroactive. The bacterial strains that produce botulinum toxin serotypes A and G possess endogenous proteases which process the toxin, and therefore, may be recovered from bacterial cultures in predominantly their active form. In contrast, botulinum toxin serotypes C 1 , D, and E are synthesized by nonproteolytic strains of Clostridium and are therefore typically inactive when recovered from culture. Subsequent activation can be performed using trypsin as a peptidase. It cleaves the prominent nicking site that is exposed preferentially to the enzyme. Serotypes B and F are produced by both proteolytic and nonproteolytic strains and therefore can be recovered in either the active or inactive form. However, even the proteolytic strains that produce, for example, the BoNT/B serotype, only cleave a portion of the toxin produced. The exact proportion of nicked to unnicked molecules depends on different factors, including the length of incubation and the temperature of the culture. Therefore, any preparation of BoNT/B is likely to contain a certain percentage of inactive toxin, which may be responsible for the known significantly lower potency of BoNT/B as compared to BoNT/A. [0017] A process for preparing neurotoxin preparations free of the associated complexing proteins is disclosed in International Patent Application No. WO 00/74703. The subject matter of this application is herein incorporated by reference. Pharmaceutical compositions comprising a botulinum neurotoxin from Clostridium botulinum , the neurotoxin being free of the complexing proteins naturally present in the botulinum neurotoxin complex, are disclosed in U.S. patent application Ser. No. 11/184,495 and corresponding PCT/US2005/025408. The subject matter of said applications, herein incorporated by reference, pertains to pharmaceutical compositions which comprise a botulinum neurotoxin from Clostridium botulinum , the neurotoxin being free of the complexing proteins naturally present in the botulinum neurotoxin complex, which pharmaceutical compositions have good stability and are advantageously formulated free of human serum albumin. [0018] Frevert, J (DE103 33 317 and WO 2005/007185) discloses a composition for stabilizing protein active ingredients, such as Clostridial neurotoxins, in pharmaceuticals comprising: a) a surface-active substance, for example a non-ionic detergent (surfactant); and b) a mixture of at least two amino acids, selected from either Glu and Gln or Asp and Asn. [0019] It has been reported that BoNT/A has been used in clinical settings as follows: (1) about 75-125 units of BOTOX® per intramuscular injection (multiple muscles) to treat cervical dystonia; (2) 5-10 units of BOTOX® per intramuscular injection to treat glabellar lines (brow furrows) (5 units injected intramuscularly into the procerus muscle and 10 units injected intramuscularly into each corrugator supercilii muscle); (3) about 30-80 units of BOTOX® to treat constipation by intrasphincter injection of the puborectalis muscle; (4) about 1-5 units per muscle of intramuscularly injected BOTOX® to treat blepharospasm by injecting the lateral pre-tarsal orbicularis oculi muscle of the upper lid and the lateral pre-tarsal orbicularis oculi of the lower lid; (5) to treat strabismus, extraocular muscles have been injected intramuscularly with between about 1-5 units of BOTOX®, the amount injected varying based upon both the size of the muscle to be injected and the extent of muscle paralysis desired (i.e. amount of diopter correction desired); and (6) to treat upper limb spasticity following stroke by intramuscular injections of BOTOX® into five different upper limb flexor muscles, as follows: (a) flexor digitorum profundus: 7.5 U to 30 U (b) flexor digitorum sublimes: 7.5 U to 30 U (c) flexor carpi ulnaris: 10 U to 40 U (d) flexor carpi radialis: 15 U to 60 U (e) biceps brachii: 50 U to 200 U. Each of the five indicated muscles has been injected at the same treatment session, so that the patient receives from 90 U to 360 U of upper limb flexor muscle BOTOX® by intramuscular injection at each treatment session. [0031] One of the reasons that BoNT/A has been selected over the other serotypes, for example serotypes B, C 1 , D, E, F and G, for clinical use is that botulinum toxin type A has a substantially longer lasting therapeutic effect. In other words, the inhibitory effect of botulinum toxin from serotype A is more persistent. [0032] Alternatively, there may be a need to use short-lasting neurotoxins such as serotype E or F or modified neurotoxins which exhibit suitable effect duration. [0033] Presently, the basis for the differences in persistence among the various botulinum toxins is unknown. However, there are two main theories explaining the differences in the persistence of the toxins. Without wishing to be bound by any theory of operation or mechanism of action, these theories will be discussed briefly below. The first theory proposes that the persistence of a toxin depends on which target protein and where on that target protein that toxin attacks—Raciborska, et al. Can. J. Physiol. Pharmcol. 77:679-688 (1999). For example, SNAP-25 and VAMP are proteins required for vesicular docking, a necessary step for vesicular exocytosis. BoNT/A cleaves the target protein SNAP-25 and BoNT/B cleaves the target protein VAMP, respectively. The effect of each is similar in that cleavage of either protein compromises the ability of a neuron to release neurotransmitters via exocytosis. However, damaged VAMP may be more easily replaced with new ones than damaged SNAP-25, for example by replacement synthesis. Therefore, since it takes longer for cells to synthesize new SNAP-25 proteins to replace damaged ones, botulinum toxin type A has longer persistence. [0034] Additionally, the site of cleavage by a toxin may dictate how quickly the damaged target proteins may be replaced. For example, botulinum toxin type A and E both cleave SNAP-25. However, they cleave at different sites and BoNT/E causes shorter-lasting paralysis in patients, compared with BoNT/A—id. at 685-6. [0035] The second theory proposes that the particular persistence of a toxin depends on its particular intracellular half-life or stability, i.e. the longer the toxin is available in the cell, the longer the effect—Keller, et al. FEBS Letters 456:137-42 (1999). Many factors contribute to the intracellular stability of a toxin, but primarily, the better it is able to resist the metabolic actions of intracellular proteases to break it down, the more stable it is—Erdal, et al. Naunynschmiedeber's Arch. Pharmacol. 351:67-78 (1995). [0036] In general, the ability of a molecule to resist metabolic actions of intracellular proteases may depend on its structures. For example, the primary structure of a molecule may include a unique primary sequence which may cause the molecule to be easily degraded by proteases or difficult to be degraded. For example, Varshavskv describes polypeptides terminating with certain amino acids as beinge more susceptible to degrading proteases—Proc. Natl. Acad. Sci. USA 93:12142-12149 (1996). [0037] Furthermore, intracellular enzymes are known to modify molecules, for example polypeptides through, for example, N-glycosylation, phosphorylation etc.—this kind of modification will be referred to herein as “secondary modification”. “Secondary modification” often refers to the modification of endogenous molecules, for example, polypeptides after they are translated from RNAs. [0038] However, as used herein, “secondary modification” may also refer to an enzyme's, for example an intracellular enzyme's, ability to modify exogenous molecules. For example, after a patient is administered with exogenous molecules, e.g. drugs, these molecules may undergo a secondary modification by the action of the patient's enzymes, for example intracellular enzymes. [0039] Certain secondary modifications of molecules, for example polypeptides, may resist or facilitate the actions of degrading proteases. These secondary modifications may, among other things, (1) affect the ability of a degrading protease to act directly on the molecule and/or (2) affect the ability of the molecules to be sequestered into vesicles to be protected against these degrading proteases. [0040] The Clostridial neurotoxin may be one of the botulinum toxin serotypes A, B, C 1 , D, E, F and G, including a botulinum toxin which is free of the complexing proteins present in natural neurotoxin or a neurotoxin modified chemically or modified by genetic manipulation. The chemically or gentically modified neurotoxin is free of the complexing proteins which naturally form complexes with botulinum neurotoxin as well. [0041] The modification of the neurotoxin derived from botulinum neurotoxin due to chemical modifying or genetic manipulation can occur on each part of the neurotoxin protein, for instance on the heavy chain part and/or on the light chain part of the neurotoxin molecule. There might be one modification or more modifications. In one embodiment, the heavy chain of the neurotoxin protein derived from botulinum neurotoxin comprises one or more modifications which may decrease or increase the affinity of the neurotoxin for binding to nerve cells when compared to the native neurotoxin. Such modified neurotoxin may comprise at least one substitution and/or deletion and/or insertion and/or addition and or posttranslational modification of amino acids of the neurotoxin and preferably of the heavy chain of the neurotoxin. [0042] There is a need to have modified neurotoxins which have efficacies of the various botulinum toxin serotypes, but with altered (shorter) biological persistence and which exhibit reduced antibody formation. SUMMARY OF THE INVENTION [0043] The present invention relates to enhancement of healing of injured surface or superficial tissue in a patient using naturally occurring and/or modified Clostridium neurotoxins, as well as those neurotoxins free of complexing proteins. Such use embraces applications in wound healing (which includes use in preventing scar formation) as well as use in ophthalmology (e.g. in treatment of injured corneal tissue, for example to close inflamed eyes). Their diagnostic usage is a further indication. Clostridium botulinum neurotoxins from serotypes A, B, C 1 , D, E, F and G are contemplated for administration to facilitate wound healing and preventing scar formation according to the desired duration of effect. Moreover, Clostridial neurotoxins which have a short duration of action and which may be free of complexing proteins may be used where a relatively short duration of muscle paralysis is desired. [0044] The invention is based on immobilizing the area around injured tissue such as a wound by paralysing the muscles acting thereon. This can be achieved by injecting a peripherally acting muscle relaxant directly into the appropriate muscles. The peripherally acting muscle relaxant is chosen from a natural or modified neurotoxin, such as a Clostridial neurotoxin, with a short duration of action and which may be free of complexing proteins. Botulinum toxins of type E and type F are embodiments of this invention. [0045] The present invention also provides for improved healing in keratitis and certain operative interventions of the eye. Closure of the eyelids can be achieved by drug-induced ptosis which is achieved by administering a peripherally and locally acting muscle relaxant. This muscle relaxant is chosen from the natural or modified short-acting neurotoxins, such as a Clostridial neurotoxin, with a short duration of action and which may be free of complexing proteins. This measure serves to immobilize the eye and thus favors healing. Botulinum toxins of type E or type F are embodiments. [0046] In another aspect of the invention, short-acting botulinum toxins which are free of complexing proteins are used as a diagnostic tool to localize the optimal area of injection for longer-acting botulinum toxins used to treat various conditions. Botulinum toxin type E is an embodiment. [0047] What we therefore believe to be comprised by our invention may be summarized inter alia in the following words: [0048] Use of a natural or modified Clostridium neurotoxin for the manufacture of a medicament for enhancing healing of injured surface or superficial tissue of a patient, wherein said medicament is manufactured for local administration into or in close proximity to said injured tissue, such a [0049] use wherein the Clostridium neurotoxin is free of complexing proteins which naturally form complexes with Clostridial neurotoxins, such a [0050] use wherein the natural or modified Clostridium neurotoxin is characterized by short-lasting efficacy of about 3 to 4 weeks, such a [0051] use wherein the Clostridium neurotoxin is botulinum toxin type F, such a [0052] use wherein the natural or modified Clostridium neurotoxin is characterized by short-lasting efficacy of about 3 to 10 days, such a [0053] use wherein the Clostridium neurotoxin is botulinum toxin type E, such a [0054] use wherein the Clostridium neurotoxin is a modified neurotoxin with an efficacy duration of about 1 to 4 weeks, such a [0055] use wherein said injured tissue comprises a wound, such a [0056] use wherein said injured tissue comprises corneal tissue and said medicament is manufactured for local administration into or in close proximity to the adjacent eyelid, and such a [0057] use wherein a two component medicament is manufactured, the first component comprising a Clostridium neurotoxin having short-lasting efficacy of about 3 to 10 days for use in determining an optimal area for administration, and the second component comprising a Clostridium neurotoxin having long-lasting efficacy of about 12 weeks for subsequent therapeutic administration. Furthermore, [0058] a method of treating a patient having a surface or superficial tissue injury, said method comprising locally administering a natural or modified Clostridium neurotoxin into or in close proximity to said injured tissue, such that healing of the injury is enhanced, such a [0059] method wherein the Clostridium neurotoxin is free of complexing proteins which naturally form complexes with Clostridial neurotoxins, such a [0060] method wherein the natural or modified Clostridium neurotoxin is characterized by short-lasting efficacy of about 3 to 4 weeks, such a [0061] method wherein the Clostridium neurotoxin is botulinum toxin type F, such a [0062] method wherein the natural or modified Clostridium neurotoxin is characterized by short-lasting efficacy of about 3 to 10 days, such a [0063] method wherein the Clostridium neurotoxin is botulinum toxin type E, such a [0064] method wherein the Clostridium neurotoxin is a modified neurotoxin with an efficacy duration of about 1 to 4 weeks, such a [0065] method wherein said injured tissue comprises a wound, and such a [0066] method wherein said injured tissue comprises corneal tissue and said Clostridium neurotoxin is administered into or in close proximity to the adjacent eyelid such that the eyelid remains closed and healing of the injured corneal tissue is enhanced. Moreover, [0067] a method of treating a patient having an ophthalmic condition requiring closure of an eyelid for healing of the ophthalmic condition, comprising local administration of a natural or modified Clostridium neurotoxin in or in close proximity to the eyelid such that the eyelid remains closed and healing of the ophthalmic condition is enhanced. Additionally, [0068] a method of determining an optimal area for injection of a Clostridium neurotoxin having long-lasting efficacy of about 12 weeks, comprising one or more initial local administrations of a natural or modified Clostridium neurotoxin having short-lasting efficacy of about 3 to 10 days in order to determine the effects of administration at a specific site or sites and thereby optimise the administration site to be used subsequently for said Clostridium neurotoxin having long-lasting efficacy, such a [0069] method wherein the natural or modified Clostridium neurotoxin is characterised by short-lasting efficacy of about 3 to 10 days and is free of complexing proteins which naturally form complexes with Clostridial neurotoxins, and such a [0070] method wherein the natural or modified Clostridium neurotoxin is botulinum toxin type E. Also, [0071] a combined medicament comprising separately administrable first and second components wherein the first component comprises a Clostridium neurotoxin having short-lasting efficacy of about 3-10 days and the second component comprises a Clostridium neurotoxin having long-lasting efficacy of about 12 weeks, and such a [0072] combined medicament further including instructions for use of said first component in determining the effects of administration to a patient at a specific site or sites so as to permit selection of an optimal site for subsequent administration of said second component. DETAILED DESCRIPTION OF THE INVENTION [0073] As described herein, wound healing after injury or surgical intervention is adversely affected by tension on the wound margins. The present invention embraces enhancement of wound healing and prevention of scar formation using naturally occurring and/or modified neurotoxins, including Clostridial neurotoxins, as well as those neurotoxins which are free of complexing proteins. This aspect of the invention is based on a new method to immobilize the area around the wound by paralyzing the muscles acting on the wound. This can be achieved by injecting a peripherally acting muscle relaxant directly into the appropriate muscles. Conventional muscle relaxants are, however, unsuitable for this for two reasons. Firstly, due to their small molecular weights they rapidly diffuse outward from the site of injection, thus producing undesirable effects in other parts of the body. Secondly, they are metabolized locally very rapidly and thus lose their efficacy. [0074] Botulinum toxin, a peripherally acting muscle relaxant, advantageously remains at the site of injection sufficiently long to be taken up by the nerves where it remains in its active form for a long period of time. Due to the toxin's high molecular weight, the amount not taken up diffuses only slowly out from the injection site. Because of its dilution in the circulating blood, more distant nerves are not affected. The toxin is quickly inactivated by proteases in the serum. The various serotypes of botulinum toxin have different durations of action. While serotypes A and B block nerves for many weeks, serotype F does so for 34 weeks and serotype E for only 3-10 days. To achieve a brief period of paralysis the toxin must be injected a few days before the operation at one or several sites around the operation field, depending on the size of the muscle to be paralyzed. Serotype E or F may be selected according to the desired period of paralysis. Since the musculature at the chosen operative site is already paralyzed by the toxin at the time of operation, the anaesthetist requires smaller amounts of postsynaptic acting muscle relaxants. The danger of postoperative respiratory impairment by paralysis of the respiratory muscles is thus reduced. As local paralysis at the site of operation is maintained for up to 4-5 days postoperatively, the wound sutures are subjected to no additional tension during this time. The period of local immobilization should be maintained maximal until the wound is completely healed, typically 1-2 weeks maximum. If wound healing is complicated, for example by secondary healing, paralysis lasting a longer period of time may be indicated. In another embodiment, where an extended duration of muscle paralysis in wound healing is desired, administration of botulinum toxin serotype A or B is warranted. Recovery of nerve function occurs slowly after breakdown of the toxins in the nerve cells and is complete approximately 2 days after full proteolytic degradation of the toxin. It is not expected that the brief immobilization leads to any significant atrophy of the muscle. [0075] In another embodiment, Clostridium botulinum neurotoxins from serotypes A or B, C 1 , D, E, F, G which are free of complexing proteins, hemagglutinins, and other exogenous proteins may be advantageously used to facilitate wound healing and prevent scar formation. As an alternative to the two commercial type A botulinum toxin complex products, BOTOX® and DYSPORT®, and also as alternative to the complexes described in the prior art of the other types (B, C 1 , D, E, F, G), a novel pharmaceutical has been developed which comprises only neurotoxin (type A, B, C 1 , D, E, F or G) free of complexing proteins, hemagglutinins and other exogenous proteins. Because of its lower molecular mass, it diffuses more quickly to the target cells in which it is taken up, before immune cells, attracted by hemagglutinins, are activated. Antigenicity studies demonstrate that neurotoxin of any type which is free of complexing proteins, induces no, or at the most very little, formation of antibodies, which is distinct from commercial products of type A and the complexes of types B to G. On therapeutic use of this newly developed pharmaceutical (neurotoxin of types A, B, C 1 , D, E, F or G which is free of complexing proteins) there is no failure of therapy due to antibodies even after repeated administration. It has also been possible to show that such neurotoxins are, because of their immediate bioavailability, still suitable for the therapy of patients who have developed, after administration of a botulinum toxin complex, e.g. after treatment with BOTOX® or DYSPORT®, an antibody titer against the appropriate type (so-called secondary non-responders), that is to say are no longer amenable to further treatment with BOTOX® or DYSPORT®, because administration of the commercial toxins no longer provides therapeutic effect. [0076] This newly developed pharmaceutical can be employed with particular advantage for patients who have never, or not for many years, been treated with botulinum neurotoxin, because their antibody titer is low or zero from the outset. The advantage of its use is then that the increase in the titer in these patients due to the treatment with pure toxin is zero, or at the most very insignificant. In other words, the newly developed therapeutic composition can be administered over long periods without losing its effect. It is also suitable for patients who exhibit an antibody titer against a botulinum toxin. [0077] The induction of antibodies during therapy with a Clostridium botulinum neurotoxin is thus prevented by administering a neurotoxin free of complexing proteins in place of the high molecular weight toxin complexes. The neurotoxin which has been completely separated from the complex proteins is immediately bioavailable and can bind directly to the nerve endings of the motor endplates. [0078] In keratitis and certain operative interventions on the eye, either a bandage is put over the eye or the upper and lower lids are sutured together to keep the eye closed. This measure serves to immobilize the eye and thus favors healing. Daily assessment of the healing process can be done at the time the bandage is changed. However, it is not possible to inspect the surface of the eye if the lids are sutured together. Closure of the eyelids can also be achieved by drug-induced ptosis, through the injection of a peripherally and locally acting muscle relaxant. Depending on the desired duration of closure, botulinum toxin E or F is injected into the levator palpebrae superioris muscle. The advantage of this procedure is obvious. The eye remains accessible for inspection so that the healing process can be monitored and any necessary further measures can be undertaken without stress to the patient. Transient ptosis is reversible, just like the paralyses described above. [0079] As has been previously described in detail, botulinum toxin serotypes A and B are used in dystonia or spasticity of different origins. If the disorder is complex or if several muscle groups are involved in the symptoms, it is often not clear which muscle should be paralyzed by the toxin to provide maximal relief for the patient. Test injections of serotype A or B would cause additional stress to the patient if they were to be injected into the wrong muscle. To localize the optimal area of injection for toxin therapy with a long-lasting efficacy toxin, a test may be conducted using a toxin which exhibits a short duration of effect. Botulinum toxin E is suitable for such a diagnostic test. The patient can experience the expected changes before the actual treatment. As its action lasts for only a few days, the patient finds out what effects will be produced later by treatment with a long-lasting efficacy toxin. Should the injection not be optimal, the disturbing effect will last for only a short time and another injection can be performed to test the effect on another muscle. EXAMPLES Example 1 [0000] Enhanced Wound Healing by Botulinum Injection in Humans [0080] A patient undergoes scar revision excision surgery. The scar is located on the abdomen. The scar was a result of a trauma, and was closed at a tertiary referral center at the time. [0081] The patient is placed in a supine position, and 5 ml of 0.5% lidocaine with 1:200,000 epinephrine is locally injected. The scar is excised and bleeding is controlled with monopolar cautery. Botulinum toxin A, which is free of complexing proteins is injected (10 units) into the wound periphery and fanning out from the wound. The wound was closed using 6-0 Vicryl for deep and 6-0 Nylon for superficial sutures. [0082] Approximately 24 hours after surgery, the patient develops marked paralysis of the injection muscles, and had lost the ability to move the skin in an area of about 4 cm in diameter around the excision. The wound heals well in the early postoperative period. It is apparent that there is decreased movement and tension on the wound edges. The wound of the patient heals without complications. Compared to the preoperative scar, the cosmetic appearance of the resulting scar 12 months postoperatively is excellent and superior to the initial scar. Example 2 [0000] Botulinum Induced Ptosis to Promote Corneal Healing [0083] A patient suffers from keratitis or undergoes surgical intervention on the eye. [0084] Botulinum toxin type E or F which is free of complexing proteins is injected into the levator palpebral superioris to produce a flaccid ptosis on the upper lid and provide safe and effective protection for the cornea. The eye is inspected to monitor the healing process. Injections are repeated until the underlying disease or condition heals. Other Embodiments [0085] It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims.

1a

BACKGROUND OF THE INVENTION An angler, who may be walking from lake to lake, usually desires to keep his gear organized and ready for use when he reaches the waterfront. Many anglers keep their lures attached to the line of their fishing rod. This can cause trouble, if, for example, a lure comes loose from the rod. Also, when the fishing rod is transported, lures can tangle with each other and/or the fishing line. This, of course, can be inconvenient and highly irritating for the fisherman. With the present invention, a fisherman can store his lures or bait in a way that prevents them from coming loose and get entangled. At the same time, manufacturers of fishing lures can pack their products in a useful carrying box, that might be of value for anglers. SUMMARY OF THE INVENTION The presently claimed can be taken off or fastened to a fishing rod or pole with a simple action. To accomplish this, the bottom of the lure box has such a shape, that it fits an attachment which is glued or taped on the rod. The lure box also has a cover, which may be hinged on the box. In the gable of the box there is a opening so, that a line or a trace can enter. Other holes could also be needed so that lures or line held therein do not rust or rot. Part of the attachment device for attaching the lure box is designed to be led into the box or matching openings in the bottom of the box so, that the lure box becomes fastened to the rod. Corresponding passages are thus made in the box in one of the gables and/or along the bottom of the box. Some kind of arrangement us provided to align the lure box in parallel to the rod. In an advantageous design, a stick portion fastened to the rod is used to engage the lure box in parallel with the rod portion can extend along the whole lure box and provides a good parallel alignment with the rod. The lure box is engaged to stick portion by slidingly inserting a pointed end of the stick portion into the outer bottom part of the lure box, such as into a groove formed therein. For the alignment of the box along the attachment device, some kind of grooves or slits in the box are needed. If there a penetration of the box from one gable to be used, grooves or slits are made on the inside of the box's bottom. Dovetail slots or the like can instead be found on the outside of the box's bottom if the attachment device has corresponding fitting flanges. In addition, there might be some kind of blocking arrangement to prevent the box from slipping off the attachment. BRIEF DESCRIPTION OF THE DRAWINGS A box is shown schematically in perspective in FIG. 1, where the box is disconnected from its attachment device on the rod. The lid of the box is closed, and the attachment device is put in place in FIG. 2. FIG. 3 is an exploded drawing of the box. FIG. 4 shows one kind of attachment device with a stick segment. A section of a box mounted on an attachment device is shown in FIG. 5. One can see some gables of boxes on sticks in FIGS. 6 and 7. An other design of the attachment device with a modified box is shown in FIG. 8. Finally a modification of the attachment device in FIG. 4 is shown in FIG. 9. DETAILED DESCRIPTION OF THE INVENTION An advantageous design of the invented box for lures and the like is shown with an open lid in FIG. 1. The box 1 has a lid 2. On the latter a locking flap 3 can be seen. There is a rise 4 inwardly formed in the bottom of the box, which rise extends from at least one gable of the box some length along the box. The rise ends with a groove 5. Below the box in FIG. 1, an attachment device to fasten the box 1 to a fishing rod is shown. This attachment device consists of half a cylinder 6, one longitudinal beam 7, and, above the beam 7, a stick or rod 8. The leading part 9 of the stick is conical or otherwise tapered. On the box there is a venthole 10, which over a slit 11 is connected to the brim of the box. The lid 2 is closed over the box 1 in FIG. 2. The lid 2 is hinged on one of the long sides of the box. This can be performed in many ways; here a hinge is made when manufacturing box as well as lid. This technique is well known by the skilled man. In FIG. 3, some drawing views (i.e., top view and left, right, and front elevational views) of a box without lid can be seen. According to these views, the depth of the box 1 is relatively small, but this is not characteristic for the invention. The depth of the box can easily be chosen by the skilled man and adapted to a desired volume. The rise 4 in the bottom of the box 1 is clearly seen in FIG. 3. The groove or slit 5 in the plane part of the bottom is also well displayed. In this figure, the length of the rise 4 and the slit 5 are each approximately equal to a third of the box's length. This length relation is however not fixed for the invention. Men skilled in the art can chose any length relation relative the size of the lures which are to be packed in the box. On some occasions, no rise is used as other designs of attachments come to use. The rise 4 is at least partially defined by a wall 12 with a hole 13 formed at one gable of the box. The width of the hole equals the diameter of the stick 8 with some additional clearance. It has been found that box and stick interrelate well even without the wall 12, but in such cases it is advisable to make the slit 5 considerably longer. In FIG. 4, the stick 8 attached to that over the beam 7 is fastened on half a circular cylinder 6. The latter is supposed to be fastened on a fishing rod, pole or the like by some known method like tape or glue. The pin 8 ends with a conical part 9 to simplify the mounting of the box on the stick. The cooperation of the two parts, the stick 8 and the box 1, is shown in FIG. 5, where the stick has been hatched. It can be seen that the height of the beam 7 is a little larger than the thickness of the box's bottom, which gives a secure attachment. The groove or slit 5 in the box is a little longer than the beam 7. According to the present invention, the beam 7 orients the box 1 along the stick 8. In addition, the conical or pointed part 9 of the stick simplifies the mounting of the box on the attachment device. Men skilled in the art understand that the box 1 should be preferably mounted with the venthole 10 and adjoining slit 11 facing the point of the rod, away from the user. The pointed end of the stick will thus face the casting reel or the handle of the rod. From this alignment it follows that a lure or bait fastened to a line and stored in the closed box will force the box to stay on the attachment device if the line is pulled taut. Also, during casting, the box will be forced to stay in place by centrifugal forces. Nevertheless, some kind of locking device to anchor the box on the stick may be provided. In FIG. 5, one example of a locking mechanism is shown. The conical part 9 of the stick 8 is long enough to be guided through a hole 14 in the right gable of the box. This part 16 of the stick is clearly shown in FIG. 5. The locking can, as the skilled individual understands, be performed by other methods like with grooves in the conical stick facing the bottom of the box. Some rises of the bottom might then form a locking device between the box and the stick. The experienced artisan can however find other locking methods, which all are covered by the following claims. The experienced man might also use dovetail slots in the box to form a dovetail joint with the beam of the attachment device. This will give a secure fastening and guidance of the box. Trials with a rise along the whole of the box's bottom have given some good results, but the box has a tendency to rotate around the rod if the attachment device is not similar to the one described above. This kind of design is shown in FIG. 6. The walls 17 of the rise are parallel. A skilled individual understand that those walls could be produced in a way so, that they should meet on the opposite side of a rod. In FIG. 7, two views of one box's gable is shown. FIG. 7a is identical with one of the views in FIG. 3. One observes, that the bottom of the box is in contact with the stick. In FIG. 7b the stick is thinner, which makes it possible to lower the rise 4 in the bottom. However, the latter design gives less stability. The stick 8 shown in FIG. 4, completing the beam 7 of the attachment device and facing the box, can, as skilled users understand, be replaced by, for example, flanges of a beam. This is shown from the side in FIG. 9, where the upper part of FIG. 4 shows the same device from above. The flanges 21 could be made in a dovetail shape matching a dovetail slot in the bottom of the box. The pointed part 9 of this dovetail simplifies the mounting of the box on the attachment device. Keeping the venthole 10 for a line or trace the box can be fastened on a plane attachment device. This is shown in FIG. 8, which has the same layout as FIGS. 3 and 4. The different views of the box are shown at the top. Here the hole 13 shown in the first box has been transformed into an laterally elongated opening 17. Through this opening, one leg 18 of the attachment device is guided into the box. Preferably now the device has plate-like form with a profile that is shown below the box in FIG. 8. The other leg of the device is, after a short distance below the box, bent to form half a cylinder 20, that, in a known way, may be fastened to a rod. The lid is not shown in this figure either, as it has no other function but to close the box. It is advantageous to produce the box and the lid in the same operation and form them from plastics. The chose of compound is left to the experienced. The beam with its stick 8 or flanges 21 together with the fastening half cylinder 6 is preferably also manufactured in one operation. Using glue for the fastening process should be considered. The half cylinder 6 also has to be flexible enough so that the attachment device can be used on rods with varying diameters. Other designs of the attachment device will be covered by the following claims. The dimensions of the box can be chosen by the skilled user considering the size of the lures or baits that are supposed to be packed and used during fishing. Big wobblers need boxes with large volume whereas small spinners or spoons only need boxes of the size, for example, 8×4×4 cm. The invented box for lures like spinners and wobblers could imply an innovation in the marketing of those products. It is the goal for the inventor that those products by routine shall be packed in this kind of box. With a consistent fixed attachment device on separate rods boxes with different fishing baits should easily be changed on a rod, which simplifies its utility for anglers and fisherman. Good order of gear can be thereby maintained without lures hooking or tangling with each other.

1a

BACKGROUND OF THE PRESENT INVENTION Field of Invention The present invention relates to a sole for footwear, and more particularly to a slip-resistant sole which is slip-resistant on a smooth surface. Description of Related Arts With the economic development, more and more building structures or construction structures are constructed with floor materials which have better leveling capability. For examples, common floor materials include marbles, ceramic floor tiles and etc. Because the floor using these materials is better leveled and smooth, the coefficient of fiction is small. When people wearing regular shoes walk on the floor constructed with these materials, he or she will easily slip and fall. Accordingly, slip-resistant shoes are emerged. In general, conventional anti-slip shoes include shoe soles with a plurality of groves laterally and longitudinally intercrossing with each other such that a plurality of small protrusions in the bottom end of the sole are formed. The protrusions are usually flat. Though this type of shoes can provide anti-slip function, the anti-slip ability is not good. SUMMARY OF THE PRESENT INVENTION An object of the present invention is to provide a slip-resistant sole which has improved slip resistance. Additional advantages and features of the invention will become apparent from the description which follows, and may be realized by means of the instrumentalities and combinations particular point out in the appended claims. According to the present invention, the foregoing and other objects and advantages are attained by a slip-resistant sole which comprises a bottom sole and a plurality of protruded units outwardly extended from the bottom sole, wherein each of the protruded unit is resilient and has a columnar structure defining a bottom end and a protruded unit cavity, wherein the protruded unit cavity is provided at the middle portion of the protruded unit in the bottom end and a side wall of the protruded unit cavity is defined, wherein the side wall of the protruded unit cavity has a curved or inclined cross-section. Preferably, the protruded unit has at least one guiding groove in the bottom end and each the guiding groove is channeled to the protruded unit cavity. Preferably, a junction groove is peripherally provided to the protruded unit and is positioned between a connecting junction between the protruded unit and the bottom sole. Preferably, a cross-section of the protruded unit is trapezium in shape defining a long side and a short side, wherein the protruded unit is connected to the bottom sole through the short side of the protruded unit. Preferably, an angle is defined between an outer side of the protruded unit and the bottom sole, wherein the angle is between 60° and 90°. Preferably, the bottom end has a round-shape, a rectangular-shape or a square-shape construction. According to the preferred embodiment of the present invention, the slip-resistant sole comprises a bottom sole and a plurality of protruded units outwardly extended from the bottom sole, wherein each of the protruded unit is resilient and has a columnar structure defining a bottom end and a protruded unit cavity, wherein the protruded unit cavity is provided at the middle portion of the protruded unit in the bottom end and a side wall of the protruded unit cavity is defined, wherein the side wall of the protruded unit cavity has a curved or inclined cross-section. Compared to conventional art, the bottom sole according to the preferred embodiment of the present invention has a protruded unit with a protruded unit cavity in which a height of the protruded unit will be decreased and the protruded unit will be deformed outwardly when a force is acted onto the bottom sole such that an adsorption force is constructed through a supporting and sucking relationship between the bottom end of the bottom sole and floor surface, thereby a friction between the bottom sole and the floor surface is increased. In addition, when the slip-resistant sole is used in wet smooth floor surface with water or oil, the deformed protruded unit can cause the water or the oil to be quickly removed through the gap between two adjacently positioned protruded unit while the guiding groove in the bottom end of the protruded unit can direct the water or the oil in the protruded unit cavity to flow outside of the protruded unit, therefore further increasing the anti-slip function. Still further objects and advantages will become apparent from a consideration of the ensuing description and drawings. These and other objectives, features, and advantages of the present invention will become apparent from the following detailed description, the accompanying drawings, and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a structural illustration of a slip-resistant sole according to a preferred embodiment of the present invention. FIG. 2 is an illustration of a protruded unit of the slip-resistant sole according to the above preferred embodiment of the present invention. FIG. 3 is an A-A′ cross-sectional illustration of a protruded unit of the slip-resistant sole according to the above preferred embodiment of the present invention. FIG. 4 is a structural illustration of a slip-resistant sole of a first alternative embodiment according to the preferred embodiment of the present invention. FIG. 5 is an illustration of a protruded unit of the slip-resistant sole of the first alternative embodiment according to the above preferred embodiment of the present invention. FIG. 6 is a B-B′ cross-sectional illustration of a protruded unit of the slip-resistant sole of the first alternative embodiment according to the above preferred embodiment of the present invention. FIG. 7 is a structural illustration of a slip-resistant sole of a second alternative embodiment according to the preferred embodiment of the present invention. FIG. 8 is an illustration of a protruded unit of the slip-resistant sole of the second alternative embodiment according to the above preferred embodiment of the present invention. FIG. 9 is a C-C′ cross-sectional illustration of a protruded unit of the slip-resistant sole of the second alternative embodiment according to the above preferred embodiment of the present invention. The structures, features, and advantages of the slip-resistant sole according to the preferred embodiment of the present invention is further described with the accompanying drawings as follows. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGS. 1, 2 and 3 of the drawings, the slip-resistant sole according to the preferred embodiment of the present invention is illustrated. According to the preferred embodiment of the present invention, the slip-resistant sole comprises a bottom sole 1 and a plurality of protruded units 2 outwardly extended from and spacedly positioned on the bottom sole 1 . The protruded unit 2 is resilient and has a columnar structure. The protruded unit 2 has a bottom end 23 and a protruded unit cavity 22 provided at the middle portion of the protruded unit 2 in the bottom end 23 . A side wall of the protruded unit cavity 22 has a curved or inclined cross-section. The provision of the protruded unit cavity 22 not only facilitate the protruded unit to deform flexibly and easily, but also creating an adsorption force through a supporting and sucking relationship with a floor surface, thereby enhancing the slip-resistant ability. The position of the protruded unit cavity 22 with curved or inclined side wall 221 can be designed or arranged based on different needs of a user. For example, the edge of an opening of the protruded unit cavity 22 is overlapped with the edge of the bottom end 23 of the protruded unit 2 , or is at a distance from the edge of the bottom end 23 of the protruded unit 2 . A cross-section of the protruded unit 2 is trapezium in shape defining a long side and a short side. The protruded unit is extended from the bottom sole through the short side of the protruded unit 2 . An angle “a” is defined between an outer side of the protruded unit 2 and the bottom sole 1 , wherein the angle is between 60° and 90°. Because the cross-section of the protruded unit is trapezium in shape while the connecting portion between the protruded unit 2 and the bottom sole 1 has a surface area smaller than a surface area of the bottom end 23 of the protruded unit 2 , the protruded unit will be deformed outwardly when a force is acted onto the bottom sole and a height of the protruded unit 2 will be decreased. Accordingly, a contacting area between the floor surface and the protruded unit 2 is increased, thereby increasing a friction between the bottom sole and the floor surface. In addition, a gap is provided between each of the protruded units 2 . Accordingly, when the slip-resistant sole is used in wet smooth floor surface with water or oil, a weight of a user will cause the protruded units 2 on the bottom sole 1 to deform, thereby causing the water or the oil to be quickly removed through the gap between two adjacently positioned protruded units 2 , thereby further increasing the slip-resistant ability. Referring to FIGS. 4, 5 and 6 of the drawings, another structural construction is provided based on the above preferred embodiment of the present invention. In particular, at least one guiding groove 21 is provided on the bottom end 23 of the protruded unit 21 and the guiding groove 21 is positioned uniformly on the bottom end 23 . The guiding groove 21 is channeled to the protruded unit cavity 22 through a distal end of the guiding groove 21 . When the slip-resistant sole is used in wet smooth floor surface with water or oil, the guiding groove 21 can direct a small amount of water or oil to flow from the protruded unit cavity 22 to outside of the protruded unit 2 , thereby increasing a coefficient of friction between the bottom sole and the floor surface and increasing the slip-resistant ability of the slip-resistant sole of the present invention. On the other hand, the protruded unit 2 is pressed to deform, therefore creating a force at three different directions on the bottom end 23 of which the force at each direction is equal, thereby the protruded unit 2 is supported through the force at three different directions. At the same time, the protruded unit cavity 22 and the floor surface have created an absorption force through their supporting and sucking relationship, thereby a coefficient of friction between the bottom sole 1 and the floor surface is increased and the slip-resistant ability of the sole is further increased. The number of the guiding groove as mentioned above can be uniformly provided on the curved surface according to the design need. For example, the number of guiding groove can be 1, 2 or more. When the number of guiding groove is two or more, the guiding grooves are spacedly provided on the bottom end 22 and a distal end of each guiding groove is channeled to the protruded unit cavity 22 respectively. According to the above embodiment, a junction groove 24 is further provided and is positioned at a connecting junction 30 between the protruded unit 2 and the bottom sole 1 . The connecting junction 30 is the junction at which the protruded unit 2 and the bottom sole 1 are connected. The junction groove 24 is not only capable of increasing a height of the protruded unit 2 , but also increasing the softness of the protruded unit 2 . In addition, when the bottom sole 1 is being acted by force from different directions, the resilient protruded unit 2 can absorb a portion of the energy and therefore the slip-resistant ability of the bottom sole 1 is enhanced. The protruded unit 2 can be made by resilient materials such as rubber and PU. The number of protruded unit 2 on the bottom sole 1 can also be adjusted according to the design need. When the number of protruded unit 2 is increased, the slip-resistant ability is increased. Referring to FIGS. 7, 8 and 9 of the drawings, the bottom end of the protruded unit 2 can be rectangular or square shape in which four guiding groove 21 is provided in the bottom end of the protruded unit 2 . The four guiding grooves 21 divide the bottom end into four sections. When the protruded unit is pressed to deform, equal forces are created through the bottom end 23 at four opposite directions. Therefore the protruded unit 2 is supported by the force at four directions and hence the bottom sole 1 is provided with slip-resistant ability. When the number of guiding groove is one, the bottom end of the protruded unit 2 is divided into two symmetrical portions. When the bottom end is pressed to deform, two equal forces are created from the bottom end 23 at two opposite directions, therefore the protruded unit 2 is supported by the force at two different directions and hence the bottom sole 1 is provided with slip-resistant ability. The number of guiding groove can be 1, 2 or more. When the number of guiding groove is two or more, the guiding grooves are spacedly provided on the bottom end 23 and a distal end of each guiding groove is channeled to the protruded unit cavity 22 respectively. One skilled in the art will understand that the embodiment of the present invention as shown in the drawings and described above is exemplary only and not intended to be limiting. It will thus be seen that the objects of the present invention have been fully and effectively accomplished. It embodiments have been shown and described for the purposes of illustrating the functional and structural principles of the present invention and is subject to change without departure from such principles. Therefore, this invention includes all modifications encompassed within the spirit and scope of the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation application of co-pending U.S. patent application Ser. No. 14/732,834, filed 8 Jun. 2015, which is a continuation of U.S. patent application Ser. No. 13/815,286, filed 16 Feb. 2013, now U.S. Pat. No. 9,078,906, which claims priority to U.S. Provisional Patent Application Ser. No. 61/634,174, filed 24 Feb. 2012, each of which is incorporated herein as though fully set forth. BACKGROUND OF THE INVENTION Technical Field [0002] The invention relates to use of crustacean hemolymph (particularly but not exclusively from lobster), or active extracts thereof or compounds therewith, to impact mammalian immune systems through topical treatments of viral and neoplastic skin lesions and wound healing. [0003] In the Homarus americanus circulatory system the heart is a single-chambered sac consisting of striated muscles with several openings called ostia. It is suspended in and surrounded by a blood sinus called the pericardium which lies directly above the pyloric stomach on the dorsal (upper) surface of the animal, just under the carapace. Invertebrates have a dorsally positioned circulatory system and a ventral nerve cord, whereas vertebrates have a ventrally located circulatory system and a dorsal nervous system. The blood, or hemolymph, passes from the pericardium, through the ostia, and into the heart. At the beginning of a contraction, the ostia close (via ostial flaps), the intracardial pressure increases, which opens the cardioarterial valves so that the heart can empty. Blood is pushed into the major arteries, most of which are directed forward to supply sensory organs and vital systems. Arteries also run toward the abdomen, both ventrally and dorsally, to supply blood to the pereiopods, ventral nerves, gut, and abdominal muscles. From these arteries the blood enters sinuses, or blood cavities. These sinuses bathe the various organs. No veins are present to return the blood to the heart. Instead, blood returns to the heart via interconnecting spaces known as venous sinuses which open back into the pericardium. Because of this architecture, the lobster's circulatory system is known as an “open” system. After contraction, the heart muscle relaxes, intracardiac pressure drops, the cardioarterial valves close, the heart is distended by action of the ligaments, the ostia open, and the hemolymph enters from the pericardium. (Lobster Conservancy, 2004) [0004] Hemolymph in arthropods is composed of water, inorganic salts (mostly Na + , Cl − , K + , Mg 2+ , and Ca 2+ ), and organic compounds (mostly carbohydrates, proteins, and lipids). Hemocytes are free-floating cells within the hemolymph. They play a role in the arthropod immune system, which resides in the hemolymph. [0005] Lobster hemolymph contains metalloproteins (proteins that include a metallic ion), most notably the oxygen-carrying hemocyanin (similar to human hemoglobin, but containing copper rather than iron). Hemocyanins are chromoprotein and account for more than 90% of all the crustacean hemolymph protein. Hemocyanins occur as hexamers composed of six heterogeneous monomeric subunits. Each subunit holds an active site of two coppers, with only one corresponding oxygen molecule. Recent studies show hemocyanins provide important immune functions in crustaceans. (Pan, 2008.) [0006] Hemolymph from mollusk and arthropods has been shown to have antiviral properties. It is not known how the hemolymph interacts with tissue to produce this effect. However, it is known that the immune system of arthropods resides in the hemolymph and the hemocytes within the hemolymph play a role, which may be part of the explanation. Immune systems protect organisms from foreign substances, also known as non-self materials, including pathogens. [0007] Unlike vertebrates, invertebrates such as crustaceans do not have immune memory or adaptive immunity; rather they rely on innate or natural immune responses. Innate immune systems are “phylogenetically a more ancient defense mechanism and can be found in all multicellular organisms. This system is the first line of defense that helps to limit infection at an early stage, and relies on germ line encoded receptors that recognizes conserved molecular patterns present on microorganisms.” (Young, 2002.) According to Soderhall, one such innate reaction in crustaceans is “the clotting process, which is very efficient and rapid and consists of a clotting protein [belonging to the vitellogenin superfamily of proteins] present in plasma and a transglutaminase in the blood cells.” (Soderhall, 1999.) [0008] Crustacean hemocytes play an important role in immune reactions, and “are capable of phagocytosis, encapsulation, nodule formation, and mediation of cytotoxicity.” (Soderhall, 1992.) [0009] This is a summary of some related work: [0010] Regarding the species Abalone— Haliotis asinine , a study has been conducted on effects of hemolymph and components on the following viruses: HIV, H1N1, Human papilloma virus, Herpesvirus, and rhinovirus. (Patent—USPTO—20110033499) Regarding the species Buckmoth—Lepidoptera: saturniidae, a study has been conducted on effects of hemolymph on the following viruses: measles, H1N1, and polio. (Greco, 2009) [0011] Regarding the species, Shrimp— Penaeus monodon a study has been conducted on effects of component hemocyanin on the following virus: White Spot Virus (Zhang, 2003) [0012] Regarding the species, Snail— Rapana venosa , a study has been conducted on effects of hemolymph on the following virus: Herpesvirus. (Dolashka-Angelova, 2009) [0013] Regarding the species Oyster— Crassostrea gigas , a study has been conducted on effects of hemolymph on the following viruses: Herpesvirus, Pancreatic necrosis virus. (Olicard, 2005) [0014] Hemocyanin extracted from keyhole limpet hemolymph been shown to be effective in treating bladder cancer. (Linn et al, 2000) [0015] Hemocyanin and arylphorin from arthropod species Eurypelma, Limulus, Astacus, Carcinus and Calliphora have been shown to be possible treatments for tumors in warm-blooded animals (Stiefel, et al. Patent—USPTO U.S. Pat. No. 5,231,081) [0016] Broad antiviral activity was found in tissues of crustacean (Blue crab— Callinectes sapidus , shrimp— Penaeus setiferus , and crayfish— Procambarus clarkia ) affecting Sindbis virus, vaccinia virus, vesicular stomatitis virus, mengo virus, banzie virus and poliomyelitis (Pan, 2000) [0017] All publications mentioned in this specification are herein incorporated by reference. [0018] Any discussion of documents, acts, materials, devices, articles, or the like that has been included in this specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed anywhere before the priority date of this application. SUMMARY OF INVENTION [0019] The inventions provides a formulation and process for utilizing hemolymph from the lobster (particularly but not exclusively Homarus americanus ), and extracts thereof and compounds therewith, as topical treatment and/or an ameliorant for both viral and neoplastic or pre-neoplastic tissue lesions, and wound healing. [0020] The invention relates to preparations, including but not limited to: liquids; ointments; slurries, powders; and/or crystals made using crustacean hemolymph with a variety of ancillary compounds, including but not limited to carageenans, starches, gelatins, vitamins, aloe, proteins, glycerins, parabens, crustacean shell powder, mineral oils, and plant oils. The hemolymph is rendered in particular but not exclusively from the lobster genus: species Homarus americanus. DETAILED DESCRIPTION OF THE INVENTION [0021] Hemolymph from the lobster, particularly but not exclusively Homarus americanus is utilized (neat or with active fragments extracted or in compounds) for the treatment in mammals of viral (such as Molluscum contagiosum, Verruca vulgaris—commonly known as warts, among others) and tissue neoplastic or pre-neoplastic lesions (such as ephelides, solar lentigos—commonly known as sun spots, and actinic keratosis, among others). By “neat” it is meant the hemolymph is in the form collected from the lobster, and by “active fragments” it is meant a fragment or fragments of the hemolymph that stimulate an immune response. [0022] Typically, the mammal treated will be human. The treatment can also be applied to other mammals such as those in the bovine, porcine, ovine, equine, canine, or feline families, among others. [0023] Preparation may involve partial drying of whole hemolymph or plasma to produce a slurry. [0024] The hemolymph can be incorporated into a cosmetic or pharmaceutical compound together with a suitable carrier or carriers i.e. carageenans, starches, gelatins, vitamins, aloe, proteins, glycerins, parabens, crustacean shell powder, mineral oils, and plant oils. In non-clinical testing, various skin lesions were exposed to lobster hemolymph neat or absorbed into fibrous absorptive material attached to adhesive tape. It was found that the topical hemolymph treatment had an atrophic and/or fading effect on said lesions. It is not known how the hemolymph interacts with tissue to produce his effect. However, it is known that the immune system of arthropods resides in the hemolymph and the hemocytes within the hemolymph play a role, which may be part of the explanation. [0025] The following examples provide further descriptive details of the invention: EXAMPLE 1 Extraction of Hemolymph from American lobster ( Homarus americanus ) [0026] Hemolymph is extracted using a variety of methods, including but not limited to: 1.1. needle and syringe to pierce the pericardial membrane to draw directly from circulatory system; 1.2. using a knife or scalpel to lance the soft tissue allowing blood flow to a catch basin or bottle; 1.3. by separating the thorax (body) from the abdomen (tail) thus opening the circulatory system at the pericardium and draining the hemolymph into a catch basin or bottle. EXAMPLE 2 Treatment of Molluscum Contagiosum With Homarus americanus Hemolymph—Neat Anecdotal Study [0030] A juvenile female human suffering from molluscum contagiosum lesions treated with neat hemolymph (“neat” is defined as that form of hemolymph extracted directly from the lobster) in a dose 0.5 ml for 5 days. The treated lesion atrophied over the course of the treatment period, whereas, adjacent lesions remained unchanged during that same time period. EXAMPLE 3 Treatment of an Actinic Lesion With Homarus americanus Hemolymph—Neat Anecdotal Study [0031] An adult male human with a facial actinic lesion was treated with neat hemolymph in a dose of 0.5 ml for approximately 10 days. Before the hemolymph was administered the lesion was prepared by lightly abrading the affected epidermis. The lesion initially blanched and then and appeared to atrophy over the course of the treatment. EXAMPLE 4 Treatment of Verruca vulgaris With Homarus americanus Hemolymph—Neat Anecdotal Study [0032] An adult male human with a manifestation of the virus Verruca vulgaris (a common wart) topically treated the lesion with neat hemolymph in a dose of 0.5 mL sporadically over two weeks. Over the course of treatment the wart softened and atrophied. EXAMPLE 5 Treatment of Herpes zoster with Homarus americanus Hemolymph—Neat Anecdotal Study [0033] An adult female exhibiting a rash from the virus Herpes zoster (shingles) topically treated the rash with neat hemolymph in a dose of approximately 0.5 ml and noticed considerable reduction is redness, itchiness and swelling in a 12 hour period. BRIEF DESCRIPTION OF THE DRAWINGS [0034] NA REFERENCES [0035] Cuthbertson, Adrian—Inventor. 2011. Original Assignee: MARINE BIOTECHNOLOGY AUSTRALIA PTY LTD. Current U.S. Classification: 424/208.1; 424/204.1; 424/209.1; 424/229.1; 424/230.1; 424/231.1; 514/3.7; 514/3.8; 514/4.2 [0036] Dolashka P, Velkova L, Iliev I, Beck A, Dolashki A, Yossifova L, Toshkova R, Voelter W, Zacharieva S. 2003. Antitumor activity of glycosylated molluscan hemocyanins via Guerin ascites tumor. Eur Urol.; 37 Suppl 3:34-40. (Institute of Organic Chemistry, Bulgarian Academy of Sciences, G. Bonchev 9, Sofia 1113, Bulgaria. pda54@ abv.bg) [0037] Greco K N, Mendonça R M, Moraes R H, Mancini D A, Mendonça R Z. 2004. Antiviral activity of the hemolymph of Lonomia obliqua (Lepidoptera: Saturniidae). Antiviral Res. Feb; 61(2):93-9. [0038] Linn J F, Black P, Derksen K, Rübben H, Thüroff J W. 2009. Keyhole limpet haemocyanin in experimental bladder cancer: literature review and own results. Antiviral Res. Oct; 84(1):84-90. Epub 2009 Aug. 7. (Department of Urology, Johannes Gutenberg University of Mainz, Germany. jflinn@compuserve.com) [0039] Lobster Conservancy. 2004. Retrieved from http://www.lobsters.org/tlcbio/biology5.html [0040] Olicard C, Didier Y, Marty C, Bourgougnon N, Renault T. 2005. In vitro research of anti-HSV-1 activity in different extracts from Pacific oysters Crassostrea gigas . Dis Aquat Organ. 2005 Nov 9; 67(1-2):141-7. PMID: 16385820 [0041] Olicard C, Renault T, Torhy C, Benmansour A, Bourgougnon N. 2005. Putative antiviral activity in hemolymph from adult Pacific oysters, Crassostrea gigas . Antiviral Res. Jun; 66(2-3):147-52. Epub Apr 26. [0042] Pan. 2008. PAN, L., & JIN, C. (2008). A review on hemocyanins of crustacean. Journal of Fisheries of China/Shuichan Xuebao, 32(3), 484-491. Retrieved from http://search.proquest.com.prxy4.ursus.maine.edu/docview/883018286?accountid=14583 [0043] Pan, J., Kurosky, A., Xu, B., Chopra, A. K., Coppenhaver, D. H., Singh, I. P, & Baron, S. 2000. Broad antiviral activity in tissues of crustaceans. Antiviral Research, 48(1), 39-47. Retrieved from http://search.proquest.com.prxy4.ursus.maine.edu/docview/17741569? accountid=14583 [0044] Soderhall, K. 1999 . Review of crustacean immunity . Retrieved from http://search.proquest.com.prxy4.ursus.maine.edu/docview/18106793?accountid=14583 [0045] Soderhall, K., & Cerenius, L. 1992. Crustacean immunity. Annual Review of Fish Diseases, 2, 3-23. Retrieved from http://search.proquest.com.prxy4.ursus.maine.edu/docview/15681912?accountid=14583 Abstract (summary) [0046] Stiefel, T., Porcher, H., Markl, J.,—Inventors. 1993. Use of hemocyanins and arylphorins to influence the immune system and for the treatment of tumors. USPTO # U.S. Pat. No. 5,231,081 [0047] Young Lee, S., & Soederhaell, K. 2002. Early events in crustacean innate immunity. Fish & Shellfish Immunology, 12(5), 421-437. doi: http://dx.doi.org/10.1006/fsim.2002.0420 [0048] Zhang X, Huang C, Qin Q. 2003. Antiviral properties of hemocyanin isolated from shrimp Penaeus monodon . (Key Laboratory of Marine Biogenetic Resources, The Third Institute of Oceanography, State Oceanic Administration, 361005, Xiamen, PR China.)

1a

TECHNICAL FIELD [0001] The present invention is concerned with improved synergistic compositions effective in the treatment of diabetes and/or hyperglycemia. In particular, the present invention is concerned with synergistic compositions comprising inulin preparations with defined degree of polymerisation (DP) characteristics and sulfonylureas and/or sulphonamides and their derivatives and/or metabolites thereof, used in the treatment of Type-2 Diabetes Mellitus (T2DM). BACKGROUND OF THE INVENTION [0002] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field. [0003] Previous studies, described in PCT/AU2011/000622, demonstrated for the first time that combination of inulin and sulfonylureas acted synergistically in inter alia lowering fasting blood glucose (FBG) levels in patients with Type-2 Diabetes Mellitus (T2DM). Synergy appeared to be restricted to sulfonylurea-class of compounds rather than—other examined anti-diabetic treatment in this study. [0004] Preparations of inulin can be heterogeneous and can vary significantly with respect to the degree of polymerization (DP). Starting with natural sources, inulin will have a different DP range depending on the source (eg. DP in the range as low as 2 to about 60 for different natural sources). Inulins with DP in the range from 2 to about 10 are also referred to as fructo-oligosaccharides (FOS) and oligofructose (OF). Extraction and processing of inulin from natural sources will further contribute to this variation in DP as well as broadening the DP range and/or bias the range towards lower DP values. None of the earlier published studies provide any indication about the useful DP range for inulin and how this parameter may influence synergy with sulfonylureas in the treatment of T2DM. [0005] There is therefore a need for better defined and improved synergistic inulin-sulfonylurea compositions, with more efficacious and predictable blood glucose level control, and improved dosing regimes. [0006] It is an objective of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art treatments, or to provide a useful alternative. SUMMARY OF THE INVENTION [0007] According to a first aspect the present invention provides improved synergistic composition comprising inulin having Degree of Polymerization (DP) below about 25 and a sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof, for the treatment of diabetes. [0008] Derivatives or metabolites of sulfonylureas, wherein such derivatives/metabolites have an active effect on altering blood glucose levels are contemplated for use in the invention. Accordingly, any mention of a “sulfonylurea” herein may also include such derivatives or metabolites. [0009] Preferably the inulin preparation will have DP below about 25, more preferably in the range of from about 2 to about 23, more preferably from about 2 to about 10 or from 3 to 10, and even more preferred are inulin preparations having a significant proportion of DP in the range from about 2 to about 5 or from about 3 to about 5. Highly preferred are inulin preparations comprising a significant proportion of F2 to F5 (ie. F2=2 fructose moieties attached via β 1-2 linkage, F4=4 fructose moieties, etc.). [0010] The sulfonylurea may be selected from Gliclazide, Glisoxepide, Glibenclamide (known also as Glyburide), Glipizide, Glimepiride, Gliquidone, Glyclopyrimide, Glibornuride, Tolazamide, Tolbutamide, Chlorpropamide, Acetohexamide, Carbutamide, Metahexamide, a derivative thereof, or combinations thereof. [0011] Sulfonamides that are chemically similar to sulfonylurea and that have an effect on altering blood glucose levels are also contemplated and their derivatives may also be used. Such sulfonamides include, e.g., antibiotic sulfonamides such as, but are not limited to, sulfamethoxazole, sulfisomidine (also known as sulfaisodimidine), sulfacetamide, sulfadoxine, dichlorphenamide (DCP) and dorzolamide. [0012] The improved synergistic compositions of the present invention may comprise one or more excipients, wherein at least one of said one or more excipients is inulin. In certain embodiments the compositions of the present invention comprise inulin as the sole excipient. [0013] Preferably the compositions of the present invention are in unit dosage form, such as tablets, capsules or the like. Such unit dosage forms may contain from about 5 mg to about 50 grams of inulin. In one example the unit dose contains about 5 to 100 mg of inulin. In another example, the unit dose contains about 100 to 500 mg of inulin. In another example, the unit dose contains about 500 to about 1000 mg of inulin. In another example, the unit dose contains about 1000 to about 2000 mg of inulin. In another example, the unit dose contains about 2000 to about 3000 mg of inulin. In another example, the unit dose contains about 3000 to about 4000 mg of inulin. In another example, the unit dose contains about 4000 to about 5000 mg of inulin. In another example, the unit dose contains about 5000 mg to about 1 g of inulin. In another example, the unit dose contains about 1 g to about 2 g of inulin. In another example, the unit dose contains about 2 g to about 4 g of inulin. In another example, the unit dose contains about 4 g to about 8 g of inulin. In another example, the unit dose contains about 8 g to about 10 g of inulin. In another example, the unit dose contains about 10 g to about 15 g of inulin. In another example, the unit dose contains about 15 g to about 20 g of inulin. In another example, the unit dose contains about 20 g to about 30 g of inulin. In another example, the unit dose contains about 30 g to about 40 g of inulin. In another example, the unit dose contains about 40 g to about 50 g of inulin. [0014] The inulin of the unit dosage form may be combined with a sulfonylurea, and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof either together in the same unit dosage form, or as separate unit dosage form, wherein the amount sulfonylurea, and/or a sulfonamide and/or derivatives and/or metabolites thereof is from about 0.5 mg to about 2000 mg, or about 1 mg to about 2 mg, or about 2.5 mg to about 5.0 mg, or about 5 mg to 10 mg, or about 10 mg to about 20 mg, or about 20 mg to about 30 mg, or about 30 mg to about 40 mg, or about 40 mg to about 50 mg, or about 50 mg to about 60 mg, or about 60 mg to about 70 mg, or about 70 mg to about 80 mg, or about 80 mg to about 90 mg or about 90 mg to about 100 mg, or about 100 mg to about 250 mg, or about 250 mg to about 500 mg, or about 500 mg to about 1000 mg, or about 1000 mg to about 1500 mg, or about 1500 mg to about 2000 mg. [0015] Preferably the unit dosage form will contain from about 500 mg to about 2000 mg of inulin and from about 1 mg to about 30 mg of sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof. Typically the unit dosage form will comprise 10 mg to 20 mg of a sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof and about 500 mg inulin. Ultimately the content of sulfonylurea will depend on the type of sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof used and the amount normally used for effective treatment of a patient's condition. This would be understood and well known by medical practitioners managing diabetic patients. [0016] According to a second aspect, the present invention provides a method of prophylactic or therapeutic treatment of diabetes comprising the administration to a subject requiring such treatment of a composition comprising inulin having a DP below about 25 and a sulfonylurea or a derivative thereof, or a sulfonamide or a derivative and/or metabolites thereof. [0017] According to a third aspect, the present invention provides a method of treating hyperglycemia comprising the administration to a subject requiring such treatment of inulin having a DP below about 25 and a sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof, in the amount and for a time sufficient to reduce, regulate or normalize blood glucose concentration. [0018] Preferably the diabetes is Type-2 Diabetes Mellitus (T2DM). [0019] According to a fourth aspect, the present invention provides a method of preventing the development of, or ameliorating, side-effects or conditions in a subject treated with a sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof, wherein the side-effects or conditions arise or are exacerbated as a result of treatment with sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof, comprising the administration to a subject requiring such treatment of inulin having a DP below about 25, in the amount and for a time sufficient to prevent or ameliorate the side effects or conditions. [0020] The side effects or conditions may be selected from hypoglycaemia, gastrointestinal disturbance, fatigue, weight gain, low mood, lack of a desire to exercise, negative changes in satiety and elevated desire to eat sweetened food or conditions associated with diabetes. Such conditions include, but are not limited to heart and blood vessel disease, nerve damage, kidney damage, eye damage, foot damage, skin and mouth conditions, low bone mineral density, Alzheimer's disease. [0021] According to a fifth aspect, the present invention provides a method of improving efficacy of sulfonylurea treatment of diabetes in a subject receiving a sulfonylurea anti-diabetic therapy, comprising administration to said subject inulin having a DP below about 25. The improvement in efficacy of sulfonylurea action means that the normal dosage of a sulfonylurea administered to a patient may be reduced. [0022] In this aspect, the treatment/therapy may include use of a derivative of sulfonylurea, and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof. [0023] The subject/patient treated in accordance with the invention may be any human or mammal subject in need of such treatment. Mammal subjects/patients include, but are not limited to, apes, gorillas, chimpanzees, endangered species, stock animals, e.g., cattle, pigs, horses, and companion animals, e.g., dogs and cats. [0024] Preferably inulin has a DP in the range of from about 2 to about 23, more preferably from about 2 to about 10 and even more preferably from about 2 to about 5. Highly preferred is inulin comprising F2 to F5 or F3 to F5. [0025] Inulin may be administered simultaneously or sequentially, in any order, with a sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof. The preferred route of administration is oral. [0026] Conveniently, inulin may be administered as a dietary supplement in daily meals or beverages (e.g. in powder or granule form as measured sachets). Inulin may be administered as fortified or formulated food forms such as chews, bars, drinks, gums, biscuits, confectionary, breads and the like. However, it is preferred that inulin is administered in a pharmaceutical unit dosage form such as pills, tablets, caplets, tapsules or capsules, for better control of dosing and patient compliance. [0027] The amount of inulin administered as described in any method herein may contain from about 5 mg to about 50 grams of inulin, or about 5 to 100 mg of inulin, or about 100 to 500 mg of inulin, or about 500 to about 1000 mg of inulin, or about 1000 to about 2000 mg of inulin, or about 2000 to about 3000 mg of inulin, or about 3000 to about 4000 mg of inulin, or about 4000 to about 5000 mg of inulin, or about 5000 mg to about 1 g of inulin, or about 1 g to about 2 g of inulin, about 2 g to about 4 g of inulin, or about 4 g to about 8 g of inulin, or about 8 g to about 10 g of inulin, or about 10 g to about 15 g of inulin, or about 15 g to about 20 g of inulin, or about 20 g to about 30 g of inulin, or about 30 g to about 40 g of inulin, or about 40 g to about 50 g of inulin. [0028] The amount of inulin administered may be combined with a sulfonylurea, and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof either together or separately, wherein the amount sulfonylurea, and/or a sulfonamide and/or derivatives and/or metabolites thereof is from about 0.5 mg to about 2000 mg, or about 1 mg to about 2 mg, or about 2.5 mg to about 5.0 mg, or about 5 mg to 10 mg, or about 10 mg to about 20 mg, or about 20 mg to about 30 mg, or about 30 mg to about 40 mg, or about 40 mg to about 50 mg, or about 50 mg to about 60 mg, or about 60 mg to about 70 mg, or about 70 mg to about 80 mg, or about 80 mg to about 90 mg or about 90 mg to about 100 mg, or about 100 mg to about 250 mg, or about 250 mg to about 500 mg, or about 500 mg to about 1000 mg, or about 1000 mg to about 1500 mg, or about 1500 mg to about 2000 mg. [0029] Preferably, the administered form will contain from about 500 mg to about 2000 mg of inulin and from about 1 mg to about 30 mg of sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof. Typically the administered form will comprise 10 mg to 20 mg of a sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof and about 500 mg inulin. Ultimately the content of sulfonylurea will depend on the type of sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof used and the amount normally used for effective treatment of a patient's condition. This would be understood and well known by medical practitioners managing diabetic patients. [0030] Unless the context clearly requires otherwise, throughout the description and the claims, the words ‘comprise’, ‘comprising’, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”. [0031] In the context of the present invention the term “inulin” is being used interchangeably with terms “oligofructose” and/or “fructoologosaccharide”. It will be understood that more complex inulins with high DP values will contain varying proportions of inulins with low DP values, which may be referred to as “oligofructose” or “fructooligosaccharide”. Such low DP value inulins may be composed of a mixture of F( m ) and/or GF( n ) wherein F is a fructose moiety, G is a glucose moiety and n and m is from 2 to about 10. BRIEF DESCRIPTION OF FIGURES [0032] FIG. 1 : Chromatogram of inulin standard [0033] FIG. 2 : Chromatogram of Orafti HP inulin (arrow indicates a DP range of about 2 to 10) and corresponding effect of this preparation on the FBG level of a patient with T2DM. [0034] FIG. 3 : Chromatogram of Orafti GR inulin (arrow indicates a DP range of about 2 to 10) and corresponding effect of this preparation on the FBG level of a patient with T2DM. [0035] FIG. 4 : Chromatogram of a commercially available inulin (Cl) (arrow indicates a DP range of about 2 to 10) and corresponding effect of this preparation on the FBG level of a patient with T2DM. [0036] FIG. 5 : Chromatogram of Orafti P95 inulin (arrow indicates a DP range of about 2 to 10) and corresponding effect of this preparation on the FBG level of a patient with T2DM. [0037] FIG. 6 : Comparison of effects of different inulin preparations on FBG level of a patient with T2DM. [0038] FIG. 7 : *Baseline FBG levels, **Inulin dose escalation, #12 gr/day inulin add-on. [0039] FIG. 8 : *Baseline FBG levels, **Inulin dose escalation, #12 gr/day inulin add-on. [0040] FIG. 9 : FBG level profile of a pre-diabetic subject during and after cessation of treatment with inulin. (¶) commercially available inulin (Cl); (§) inulin (Orafti GR), ( ) discontinued treatment with inulin. [0041] FIG. 10 : Continued effect of inulin on FBG levels in a patient on Gliclazide monotherapy in combination with 15 gr/day of inulin (Cl); The graph shows the initial treatment study as previously shown in FIG. 2 of PCT publication WO 2011/146981 (left portion as labelled), which was further continued beyond 24 months (right portion as labelled). [0042] FIG. 11 : Continued effect of inulin on FBG levels in a patient on treatment with sulfonylurea, Glibenclamide, mono therapy in combination with 15 gr/day of Cl; The graph shows continued treatment beyond 61 months (as labelled) and is a continuation of the treatment study shown in FIG. 3 of PCT publication WO 2011/146981. [0043] FIG. 12 : Schematic diagram showing the relationship between inulin and FOS (left) and the chemical structure of scFOS (right). [0044] FIG. 13 : Schematic diagram of general manufacturing process for OFP. DESCRIPTION OF THE PREFERRED EMBODIMENT [0045] The present invention is based in part on the observation that different inulin preparations appear to synergize with sulfonylureas to different extent, judging by the dosage of inulin required to achieve effective synergy in the treatment of Type-2 Diabetes Mellitus (T2DM) patients. The present invention is concerned with assessing the useful degree of polymerization (DP) range for inulin preparations, preferably food grade, for achieving synergy with sulfonylureas in lowering or normalising FBG levels in patients with T2DM. [0046] Oligofructose (OF) consists of a mixture of inulin fructans each comprising a terminal glucose molecule and sequentially linked fructose molecules. The fructosyl-glucose linkage is Beta-(2→1) and the fructosyl-fructose linkages are Beta-(1→2). The maximum number of fructose moieties bound (or the degree of polymerisation, ie. DP) is dependent on the source of the material. Plant, bacterial and fungal derived Oligofructose exists. Plant fructans do not exceed DP of 200, with the most common, Chicory, having an upper limit of DP value approximately 60. Bacterial fructans can have a DP as high as 100,000. Oligofructose is the partially hydrolysed, purified extract of linear fructans, obtained as native inulin, predominantly from chicory ( Cichorium intybus ) root. When derived from chicory, native inulin is purified via sequential hot water extraction, demineralisation, decolourisation, activated carbon treatment, micro-filtration, & concentration, e.g., as further described in the Examples. [0047] It has been shown herein that inulin preparations that include a proportion having a DP below about 25, and preferably in the range from about 2 to about 23 or about 3 to about 23, more preferably about 2 to about 10 or about 3 to about 10, and even more preferably about 2 to about 5, particularly F2 to F5 or F3 to F5, are likely to synergize better with sulfonylurea to lower or normalize FBG levels than inulin preparations with higher DP values. Inulin with desirable and advantageous DP values and/or with defined OF and FOS may be obtained by enzymatic treatment of inulin extracted from a suitable plant source or purchased from a commercial source, e.g., as further described in the Examples. Lower DP value inulins (eg. DP below about 25 and/or about 2 to 23 or a lower range) may be produced using different manufacturing methods well known and established in the art, and e.g., as further described herein in the Examples. Briefly, for example, by synthesizing the inulin from basic building blocks starting from sucrose (G-F) and adding fructose molecules using fructosyl transferase (Bornet 1994) (1) or by partial enzymatic hydrolysis of inulin, extracted from a natural source or obtained from a commercial source, into smaller chain lengths (De Leenheer 1996) (2). A further method for preparing low DP inulins, in particular FOS, is provided in Csanadi and Sisak 2008 (3). The resultant product is then purified, sterilized and spray dried using techniques well established in the art. [0048] Inulin preparations of the present invention may be combined with any of the sulfonylureas currently used for the treatment of T2DM. Previous studies (PCT/AU2011/000622) have shown that inulin synergises effectively with sulfonylureas such as Gliclazide and Glibenclamide in lowering or normalizing FBG levels in T2DM patients. The present study demonstrates inulin synergy with other sulfonylureas, such as Glimepiride and Glipizide, further enforcing the original postulate that inulin synergises with any sulfonylurea. Thus, based on the chemical structure and mode of action of sulfonylureas, which may be the underlying mechanism of the observed synergy with inulin, it will be understood that inulin will synergize with other sulfonylureas such as for example Glibornuride, Glisoxepide, Gliquidone, Glyclopyrimide, Tolazamide, Tolbutamide, Carbutamide, Metahexamide, Chlorpropamide and Acetohexamide. [0049] The amount of sulfonylurea and/or a sulfonamide and/or metabolites derivatives and/or metabolites thereof, or combinations thereof administered to a patient may be varied, including reduced, depending on a patient's response to combined treatment with an inulin preparation. This may be achieved using any standard methods known in the art for monitoring FBG levels. For example, FBG may be measured before commencing treatment and then continuously monitored at desired intervals to determine the patient's response to combined treatment with an inulin preparation. The adjustment of the amount of sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof administered if required will be apparent to a medical practitioner. [0050] Inulin may be administered to a patient receiving a sulfonylurea agent and/or a sulfonamide agent and/or derivative and/or metabolites agents thereof, or combination agents thereof either at the start of treatment with the agent, and administration continued for as long as the patient is treated with and/or a sulfonamide and/or derivatives thereof, or combinations thereof, or may be administered intermittently as required to regulate/normalize blood glucose levels. The effect of co-administration of inulin and a and/or a sulfonamide and/or derivatives thereof, or combinations thereof on blood glucose levels may not be seen in the short term and hence co-administration may need to be maintained for a period of time long enough to achieve the desired effects, for example in excess of 2 to 3 months and preferably 4 to 6 months. Based on the patient's condition, nature of treatment and response, longer periods of administration of inulin may be required before beneficial effects are noted. Of course it will be understood that such co-administration may be maintained for as long as the patient requires treatment for diabetes or hyperglycaemia. [0051] The compositions of the present invention, in addition to being effectively used in the treatment of patients with T2DM, may also be used to treat subjects with hyperglycemia who are not yet classified as diabetic (i.e. pre-diabetic) but who are nevertheless on low level sulfonylurea treatment, so as to prevent or delay onset of diabetes. [0052] The compositions of the present inventions can be administered by a variety of routes including oral, rectal, transdermal, subcutaneous, intravenous, intramuscular, intrathecal, intraperitoneal, intranasal and buccal. Depending on the intended route of delivery, the compounds are preferably formulated as either oral, injectable or topical compositions. [0053] The compositions for oral administration may take the form of bulk liquid solutions or suspensions, or bulk powders and the like. For example, in case of inulin or a natural source thereof, the compositions can be in the form of a food supplement, for example a powder or a suspension that can be simply added to daily meals before consumption. It may also take the form of fresh, dried or semi-dried parts of plants, to be used in a similar manner. [0054] The agents or compounds of the present invention may be prepared as separate compositions, for either sequential or simultaneous administration, or may be formulated together in a combination composition/unit dosage form. It will be understood that separate compositions may also each be formulated in unit dosage form. Such compositions, together with a conventionally employed adjuvant, carrier, diluent or excipient may be placed into the form of pharmaceutical compositions and unit dosages thereof, and in such form may be employed as solids, such as tablets or filled capsules, or liquids such as solutions, suspensions, emulsions, elixirs, or capsules filled with the same, all for oral use. [0055] Liquid forms suitable for oral administration may include a suitable aqueous or nonaqueous vehicle with buffers, suspending and dispensing agents, colorants, flavors and the like. Solid forms may include, for example, any of the following ingredients, or compounds of a similar nature: a binder such as microcrystalline cellulose, gum tragacanth or gelatin; an excipient such as starch or lactose, a disintegrating agent such as alginic acid, Primogel, or corn starch; 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, methyl salicylate, or orange flavoring. [0056] For certain applications the compositions may also be in the form of sterile injectable solutions for parenteral (including but not limited to intravenous, subcutaneous, intramuscular use). Such pharmaceutical compositions and unit dosage forms thereof may comprise ingredients in conventional proportions, with or without additional active compounds or principles, and such unit dosage forms may contain any suitable effective amount of the active ingredient(s) commensurate with the intended daily, weekly, monthly or other dosage range to be employed. Injectable compositions are typically based upon injectable sterile saline or phosphate-buffered saline or other injectable carriers known in the art. [0057] The amount of each composition actually administered will typically be determined by a physician in the light of the relevant circumstances, including the condition to be treated, the chosen route of administration, the actual compound(s) administered, the age, weight, and response of the individual patient, the severity of the patient's symptoms/condition, and the like. [0058] The above described components for orally administered or injectable compositions are merely representative. The composition may be formulated for administration. Processing techniques known in the art maybe used, as well as known pharmaceutically acceptable carriers, diluents or excipients. To prepare such formulations, compositions described herein, containing active ingredient(s) are mixed with a pharmaceutically acceptable carrier or excipient for example, by mixing with physiologically acceptable carriers, excipients, or stabilizers in the form of, e.g., lyophilized powders, slurries, aqueous solutions, or suspensions (see generally Remington's Pharmaceutical Sciences, (4) and e.g., references (5) to (10) and the Examples. [0059] The compounds of the present invention can also be administered in sustained release forms or from sustained release drug delivery systems, either in separate dosage forms or in a combination dosage form. A description of representative sustained release materials can also be found in the incorporated materials in Remington's Pharmaceutical Sciences, and e.g., references (5) to (10). Such administration can also occur via bolus administration, or via implantable devices, or patches or the like. [0060] Preferably, the compositions are presented in unit dosage forms to facilitate accurate dosing. The term “unit dosage forms” refers to physically discrete units suitable as unitary dosages for human subjects and other mammals (for example companion animals or stock animals, or any other animal as described herein), each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect, in association with a suitable pharmaceutical excipient e.g., as described in the Examples. Typical unit dosage forms include prefilled, premeasured ampoules or syringes of the liquid compositions or pills, tablets, capsules, caplets, tapsules or the like, in the case of solid compositions. [0061] The unit dosage forms of the present invention, such as a tablet or capsule, may comprise from 0.5 to about 2 g of a sulfonylurea and about 5 mg to about 50 g of inulin, or as described herein. In practice however, a typical dosage form may comprise about 1 mg to 2 mg of a sulfonylurea and/or a sulfonamide and/or derivatives and/or metabolites thereof, or combinations thereof, and about 500 mg of inulin. In a typical treatment regimen this would mean taking about 4 unit dosage forms three times a day to achieve the desired therapeutic effect (eg. lowering blood glucose levels). However, depending on the exact nature of inulin and its compressibility (in case of a tablet unit dosage form), higher amounts of inulin may be used, for example 2000 mg, or even more, per dosage form, thus reducing the number of dosage forms that need to be taken in order to achieve the desired therapeutic effect. [0062] In the compositions of the present invention, particularly when they are in unit dosage form, inulin may also serve as one of a number of excipients or may be the sole excipient in the formulation, thus acting as both an active and an excipient. [0063] Further design and inclusion criteria are also contemplated based on the ability of one or more additional substances that may be added to compositions to facilitate or synergise the dosage of the composition via, for example, release modifying agents that may include physical and/or chemical modifications to the formulation. Physical modifications may include, e.g., dispersion agents, gas generation substances, size and structure modifications or selections including nanoparticles. Chemical modifications may include e.g., pH modification agents, buffers, co-solvents, polymers, plasticizers. Metabolism modifying agents may also be included, e.g., fats, proteins, carbohydrates, salts, minerals, as well as substances known to affect the GI (Glycemic index), competitors for drug binding sites, enzyme inhibitors, enzymes, hormones and the like. [0064] Co-medications or substances that redress or modify the adverse effects of sulfonylureas such as vascular attack, pancreatic depletion; or vitamin, mineral or other nutritive substances may also be added to the compositions of the invention, or further administered in the methods or use of the invention. [0065] The present invention will now be described in more detail with reference to specific but non-limiting examples describing specific compositions and methods of use. It is to be understood, however, that the detailed description of specific procedures, compositions and methods is included solely for the purpose of exemplifying the present invention. It should not be understood in any way as a restriction on the broad description of the inventive concept as set out above. EXAMPLES Example 1 Analytical Testing of Inulin Preparations [0066] The analyses of inulin preparations were performed by Australian Proteome Analysis Facility (Research Park Drive, Macquarie University, Sydney, NSW, 2109, Australia), as briefly described below. Standard and Sample Details: [0067] For convenience, all inulin samples/preparations were purchased from commercial sources. Inulin standard was purchased from Sigma Aldrich (PN: 12255-10G, LN: 099F71251V) and four different inulin preparations, namely Orafti HP, Orafti GR, Orafti P95, all obtained from Orafti Inc., Belgium, and a commercially available inulin (CI), (obtained from Just Like Sugar, Inc., Las Vegas, Nev., USA), were analysed. Analysis Procedure: [0068] A standard inulin solution and four inulin preparation were prepared at a concentration of 1 mg/ml by dissolving in hot MilliQ water and cooling to room temperature before use. A solution of each was made fresh each day and analysed under identical conditions. All samples and standards were performed on 3 consecutive days. The analysis of the standard and each sample was conducted over 3 separate runs according to the schedule below: [0069] Standard and inulin samples were freshly prepared for each at different days at 1 mg/ml. Inulin solvent (MilliQ water) was used as a blank. The instrument was set to run the samples in the following sequence: [0070] Standard, blank, any SAMPLE, blank, any SAMPLE, blank, any SAMPLE, blank, any SAMPLE, blank, any SAMPLE, blank, Standard. Instrument and Method: [0071] The analyses of the standard and 4 samples were undertaken on a Dionex high-performance anion-exchange chromatography system with pulsed amperometric detection (HPAEC-PAD)—(Dionex Pty Ltd, Lane Cove, Australia). Method: [0072] Guard Column: CarboPac PA200 guard column (3×50 mm) Column: CarboPac PA200 column (3×250 mm) Column Temperature: 30° C. [0073] Injection volume: 25 μL Flow rate: 0.5 mL/min Solvents: A=100 mM NaOH [0000] B=500 mM CH 3 COONa in 100 mM NaOH C=MilliQ water D=200 mM NaOH Gradient: [0077] [0000] Time (min) % A % B % C % D 0 77.6 2.4 0 20 5 77.6 2.4 0 20 40 56 24.0 0 20 45 56 24.0 0 20 55 77.6 2.4 0 20 Quality, Accuracy and Precision of the Results: [0078] All three runs demonstrated identical results for the inulin standard and the four inulin preparations tested. Three peaks were selected as reference points (to assess performance of the system such as accuracy, precision etc.), one at the front, one in the middle and one at the end of the profile. Analysis of these peaks, from each sample across the three runs showed a % RSD<1% for the retention time and <5% for the number of peaks detected. The area and height varies between each replicate analysis due to deviation in sample weights. The number of peaks detected, peak area and height is dependent on parameters set in the Dionex Chromeleon software. [0079] The numbers above the chromatogram peaks are for labeling and referral purposes only. By way of brief explanation, when a peak is integrated the system software places a number above the peak. Thus, the peak labeled “1” in each of the chromatograms corresponds to peak “1” in a table from which the chromatograms are and allows a cross-reference to the data associated with that peak. The X axis units are retention time and the Y-axis units are nC (nanoCoulombs). [0080] Inulin standard from Sigma Aldrich was used to standardize the instrument ( FIG. 1 ). Once standardized the instrument with the exact same procedure/method was used to evaluate the chromatogram for each inulin preparation that was used in the treatment of the T2DM patient. Example 2 Glibenclamide/Inulin Co-Therapy in T2DM Patient—Effect of Different Inulin Preparations Clinical Data: [0081] The patient data provided herein has been obtained in accordance with the methodology and procedures described in PCT/AU2011/000622, incorporated herein by reference. Subject: [0082] 65 years old female, with body mass index of 30 classified as obese, with the history of T2DM, atrial fibrillation, high blood pressure, high blood cholesterol and osteoarthritis. Medical History: [0083] At the age of 49 the patient was diagnosed with T2DM. The patient was treated for diabetes with Glibenclamide (Alphapharm Pty Ltd) (3×5 mg/day=15 mg/day). OTC or Other Supplements: [0084] [0000] Inulin: 12 grams/day 4 grams-3 times a day [0085] The sources of inulin preparations are described above in Example 1. Glucose Measurements: [0086] Blood glucose level was determined using Accu-Chek Performa (Roche, Mannheim, Germany) device (CAT/TYP 04680464002 mmol/L and 55404204955) according to manufacturer instructions. Other similar devices can also be used. Results: [0087] Effect of Orafti HP preparation: [0088] Prior to intake of Orafti HP inulin, patient consumed CI at 15 g/day with average monthly FBG levels of 5.7±0.21 mmol/L (not shown). After one month of consumption of ˜21 g/day, the food grade Orafti HP inulin preparation that is characterized by a DP range of above 23 resulted in a dramatic increase in FBG levels from 5.7±0.21 mmol/L to monthly average of 8.8±0.7 mmol/L. The chromatogram of the inulin preparation and corresponding effects of this inulin preparation on patient's FBG level is shown in FIG. 2 . Due to this increase, consumption of Orafti HP inulin was terminated and patient continued to take CI (characterized by a DP range of about 2 to 60) until the FBG levels returned to normal. Patient claimed that during Orafti HP inulin intake the symptoms of diabetes, such as lethargy, sweating, muscle weakness and pain had returned. Effect of Orafti GR Preparation: [0089] Prior to intake of Orafti GR inulin, patient consumed CI at 15 g/day with average monthly FBG levels of 5.2±0.2 mmol/L. After one month of consumption of ˜15-21 g/day, the food grade Orafti GR inulin preparation that is characterized by a DP range of between about 10-60 (certain amount of inulin with values for DP lower than 10 was also present) resulted in increased FBG levels from 5.2±0.2 mmol/L to 6.8±0.2 mmol/L. Further increasing Orafti GR intake to 30 g/day resulted in normalization of FBG levels. The chromatogram of the inulin preparation and corresponding effects of this inulin preparation on patient's FBG level is shown in FIG. 3 . Patient claimed feeling well during consumption of this high dose of Orafti GR. Effect of CI Inulin Preparation: [0090] Patient, as described above, consumed CI at 15 g/day with normalization of FBG levels at all times. The chromatogram of this inulin preparation and corresponding effects of this inulin preparation on patient's FBG level is shown in FIG. 4 . Effect of Orafti P95 Preparation: [0091] Prior to intake of Orafti P95 inulin, patient consumed CI at 15 g/day with average monthly FBG levels of 5.4±0.3 mmol/L. After one month of consumption of ˜12 g/day, the food grade Orafti P95 inulin preparation that is characterized by a DP range of between 3-10 provided normal FBG levels. The chromatogram of Orafti P95 inulin preparation and corresponding effects of this inulin preparation on patient's FBG level is shown in FIG. 5 . Patient has claimed that during Orafti P95 she felt very well and no symptoms of diabetes occurring. She claims that this preparation provided best effect with respect to diabetic symptoms. Discussion: [0092] Comparison of the effects of different inulin preparation on a type 2 diabetes mellitus patient demonstrated that inulin preparations with a lower DP range provide better synergy with sulfonylurea in normalizing FBG levels. [0093] Normalization of FBG levels by Orafti GR required higher amounts of this inulin to be consumed (at ˜30 g/day). Since approximately half of this preparation (compare the chromatogram in FIG. 3 with FIG. 2 and FIG. 4 , range represented by an arrow) possessed inulin with DP below 23, twice the amount of this preparation was required for normalization of FBG when compared to CI (15 g/day). On the other hand CI contained more inulin with DP below about 23 (approximately 70-80%) which resulted in better synergisms with sulfonylurea. [0094] In contrast to the above results, normalization of FBG by Orafti P95 required lower amounts of this inulin to be consumed (at ˜12 g/day). Since all of this preparation (compare the chromatogram in FIGS. 2-5 ) possessed inulin with DP below about 10, even slightly lower amounts of this preparation were required for normalization of FBG when compared to CI (15 g/day). Overall Findings: [0095] From these findings it is clear that inulin with lower DP range, for example below about 23 but preferably in the range of about 2 to 23 and more preferably in the range of about 2-10, and even more preferably from about 2 to about 5. Highly preferred is inulin comprising F2 to F5 provides better synergy with sulfonylurea than higher DP ranges, eg. above about 23 (see FIGS. 2 to 6 ) Example 3 Glimepiride/Inulin Combination Therapy for Type 2 Diabetes Mellitus: A Case Report Subject: [0096] 59 years old female, with body mass index of 33 classified as obese, with the history of T2DM, and osteoarthritis. Medical History: [0097] At the age of 55 the patient was diagnosed with T2DM. Doctor recommended diet-only treatment. At age 57 due to increased FBG levels the patient was treated with Glimepiride (1 mg/day, 1 mg once daily). The dose was increased in a 1 mg increment and currently this patient is taking 4 mg once daily Glimepiride. OTC or Other Supplements: [0098] [0000] Glucosamine 1500 mg/day twice daily Inulin (CI):  12 grams/day 4 grams-3 times a day Methods: Glucose Measuring Device: [0099] Blood sugar level was determined using Accu-Chek Performa (Roche, Mannheim, Germany) device (CAT/TYP 04680464003 mmol/L and 55405079196) according to manufacturer instructions. Results: [0100] The efficacy of inulin on Glimepiride monotherapy was investigated. A couple of years prior to inulin combination therapy, patient's FBG level fluctuated and was uncontrolled above 7 mmol/L. FIG. 7 depicts the monthly FBG level average at indicated time points. Conditions of treatments are described below: June 2011: [0101] During baseline measurements of FBG levels, patient was on Glimepiride at the dose of 4 mg once daily. July 2011: [0102] Inulin introduced at 3 gr/day (1 gr with each meal, 3 times a day) for one week. Inulin amount was increased to 6 gr/day (2 gr with each meal, 3 times a day) at week 2, 9 gr/day (3 gr with each meal, 3 times a day) at week 3 and 12 gr/day (4 gr with each meal, 3 times a day) at week 4. August-October 2011: [0103] Patient continued taking Inulin with each meal at 4 gr/meal (12 gr/day total). The data demonstrates ˜2 mmol/L reduction, from ˜8 mmol/L at baseline to ˜6 mmol/L at the end of 3 months Inulin intake. Results are shown in FIG. 7 . [0104] The FBG level of the patient is restored to near normal levels when inulin was consumed at approximately 12 grams/day in combination with Glimepiride. The patient also claims that consumption of inulin boosted energy, increased bowel movements, alleviated muscle pains, and overall provided a better quality daily life. Example 4 Glipizide/Inulin Combination Therapy for Type 2 Diabetes Mellitus: A Case Report Subject: [0105] 54 years old male, with body mass index of 29 classified as overweight, with the family history of T2DM. Medical History: [0106] At the age of 50 the patient was diagnosed with T2DM. Doctor recommended diet-only treatment. At age 52 due to increased FBG levels the patient was treated with Glipizide (5 mg/day, 5 mg once daily). The dose was increased in a 5 mg increment and currently this patient is taking 15 mg/day, 5 mg three times a day, Glipizide. Other Supplements: [0107] [0000] Inulin (CI) 12 grams/day 4 grams-3 times a day Methods: Glucose Measuring Device: [0108] Blood sugar level was determined using Accu-Chek Performs (Roche, Mannheim, Germany) device (CAT/TYP 04680464002 mmol/L and 55403057614) according to manufacturer instructions. Results: [0109] The efficacy of inulin on Glipizide monotherapy was investigated. A couple of years prior to inulin combination therapy, patient's FBG level was reasonably controlled around 7 mmol/L. FIG. 8 depicts the monthly FBG level average at the indicated time points. Conditions of treatments are described below: July 2011: [0110] During baseline measurements of FBG level, patient was on Glipizide at the dose of 15 mg per day. August 2011: [0111] inulin introduced at 3 g/day (1 g with each meal, 3 times a day) for one week. Inulin amount was increased to 6 g/day (2 g with each meal, 3 times a day) at week 2, 9 g/day (3 g with each meal, 3 times a day) at week 3 and 12 g/day (4 g with each meal, 3 times a day) at week 4. September-October 2011: [0112] Patient continued taking inulin with meal at 4 g/meal (12 gr/day total). The data demonstrates ˜1.5 mmol/L reduction, from ˜6.5 mmol/L at baseline to ˜5 mmol/L at the end of 2 months inulin intake. Results are shown in FIG. 8 . [0113] The FBG level of the patient is restored to normal levels when inulin is consumed at approximately 12 g/day in combination with Glipizide. The patient also claims that consumption of inulin, increased bowel movements, and overall provided a better quality of life with increased energy levels resulting in increased daily walks and exercise. Example 5 Effect of Inulin Monotherapy and its Withdrawal on Fasting Blood Glucose Levels of a Pre-Diabetic Individual: A Case Report Subject: [0114] 46 years old male, with body mass index of 28 classified as overweight, with the family history of T2DM. Methods: Glucose Measuring Device: [0115] Blood sugar level was determined using Accu-Chek Performa (Roche, Mannheim, Germany) device (CAT/TYP 04680464003 mmol/L and 55405441515) according to manufacturer instructions. [0116] This subject, who was predisposed to diabetes but not treated with any anti-diabetic medication, and who had FBG levels above normal limits (approx. 6.0 mmol/L), also consumed inulin, first inulin (CI) (¶) then inulin (Orafti GR) (§), for 13 months. In contrast to patients who were under sulfonylurea treatment, the consumption of 12-15 g/day of inulin over the period of 13 months did not change the levels of FBG in this subject. Discontinuation of inulin ( ) for six month did not result in any significant changes in FBG levels of this individual ( FIG. 9 ). Example 6 Gliclazide/Inulin Combination Therapy for Type 2 Diabetes Mellitus: A Case Report [0117] This Example shows extended data from a patient, who was under Gliclazide therapy (30 mg, once daily) for nearly a decade with uncontrolled blood glucose levels above 9 mmol/L. This patient began the combination therapy with a commercially available inulin (Cl) as previously described in PCT/AU2011/000622, the contents of which are incorporated herein in their entirety. Various blood parameter measurements were as described PCT/AU2011/000622. The results are shown in FIG. 10 and Table 1 below demonstrating the efficacy of inulin combination therapy is sustained beyond 24 months. [0000] TABLE 1 FBG, HA1C and Lipid profiles of the patient performed by an independent pathology laboratory. 22/07/2008 20/04/2009 17/12/2010 16/05/2011 19/10/2011 10/07/2012 23/10/2012 Fasting Glucose 6.0 7.7 7.4 5.1 7.3 7.5 8.2 (Normal 3-5.5 mmol/L) HA1c (Normal <7%) 7.0 7.2 7.8 7.2 7.6 7.2 Cholesterol (Normal 3.1-5.1 mmo/L) 4.4 4.2 2.9 4.4 4.7 4.8 4.3 Triglycerid (Normal 0.5-2 mmol/L) 1.2 1.5 0.8 1.2 0.9 1.4 0.9 HDL (Normal >1 mmol/L) 1.0 1.2 1.1 1.2 1.4 1.3 1.4 LDL (Normal 0-3.5 mmol/L) 2.9 2.3 1.4 2.6 2.9 2.9 2.5 Coronary risk ratio (Normal <5) 2.6 3.4 3.7 3.1 Example 7 Glibenclamide/Inulin Combination Therapy for Type 2 Diabetes Mellitus: Evaluation of extended efficacy for over 62 weeks [0118] This Example shows extended data from a patient as described in Example 3 of PCT/AU2011/000622 who continued taking CI for an extended period of time (over 5 year), and combination therapy with Glibenclaminde (5 mg, three times daily) and continued following a similar protocol as described Maintaining the patient on combination therapy with this inulin preparation has normalized the FBG levels and maintained them within the normal range. The results of this study are shown in FIG. 11 and Table 2 below. Various blood parameter measurements were as described PCT/AU2011/000622. The results are shown in FIG. 11 and Table 2 below demonstrating the efficacy of inulin combination therapy is sustained beyond 63 months. Maintaining the patient on combination therapy with this inulin preparation has normalized the FBG levels and maintained them within the normal range. [0000] TABLE 2 FGL, HA1C and Lipid profiles of a patient who was on CI add-on and glibenclamide monotherapy 5/11/ 31/05/ 24/10/ 27/04/ 17/01/ 7/03/ 2/09/ 2006 2008 1/10/2008 12/12/2008 2009 2/03/2010 7/03/2010 2010 2011 2011 2011 Fasting Glucose (Normal 3-5.5 mmol/L) 10 6 6.3 5.1 7 6.4 5.4 7.5 6.9 HA1c (Normal <7%) 6.5 7 6.6 6.9 6.9 6.8 6.9 6.5 Cholesterol (Normal 3.1-5.1 mmo/L) 6.2 3.1 3.6 3.8 4.4 4.4 3.8 4.3 Triglycerid (Normal 0.5-2 mmol/L) 4 1.1 1 1 1 1.6 1.5 1.2 HDL (Normal >1 mmol/L) 1.2 1.2 1.4 1.3 1.1 1.6 LDL (Normal 0-3.5 mmol/L) 1.4 1.9 2.5 2.4 2 2.1 Coronary risk ratio (Normal <5) 2.6 3 3.1 3.4 Example 8 Example of Compositional Guideline for Oligofructose Preparations and Naming of Different Molecular Structures [0119] [0000] TABLE 3 Oligofructose content of different inulin preparations (including guide to oligofructose terminology). The relative concentrations of the oligofructose has been determined at the Australian Proteome Analysis Facility. Names Short General Relative conc. Name name (a) (b) CAS (%) G Glucose 921-60-8 0.5 ± 0.4  4-12% F Fructose 30237-26-4 3.1 ± 0.3 GF Sucrose 57-50-1 3.9 ± 1.4 GF 2 Difructoolig Kestose trisaccharides: 1-kestose 470-69-9 2.1 ± 1.2 osaccharide (1F-b-d- fructofuranosylsucrose) F 2 Inulobiose 9005-80-5 2.5 ± 1.5 GF 3 Trifructoolig Nystose neokestose (6G-b-d- 13133-07-8 3.15 ± 0.3  82-91% osaccharide fructofuranosylsucrose); F 3 Inulotriose 58208-59-6 14.9 ± 0.5  GF 4 Tetrafructooligosaccharide Fructofuranosylnystose Tetrasaccharides: 6.3 ± 0.1 (DP5) nystose [1F(1-b-d- fructofuranosyl)2 sucrose], 6G(1-b-d- fructo-furanosyl)2 sucrose and 1F(1-b-d- fructofuranosyl)-6G(1-b- d-fructofuranosyl) sucrose; F 4 Inulotetrose 16.1 ± 0.8  GF 5 Pentafructooligosaccharide Difructofuranosylnystose Pentasaccharides: 1F(1- 7.2 ± 1.8 (DP6) b-d-fructofuranosyl)3 sucrose, 6G(1-b-d-fructo- furanosyl)3 sucrose, 1F(1-b-d- fructofuranosyl)2-6G (1- b-d-fructofuranosyl) sucrose and 1F(1-b-d- fructofura nosyl)-6G(1-b- d-fructofuranosyl)2 sucrose, F 5 Inulopentose 9.4 ± 0.5 GF 6 Hexafructooligosaccharide Trifructofuranosylnystose Hexasaccharides: 1F(1-b-   4 ± 0.8 (DP7) d-fructofuranosyl)4 sucrose, 6G(1-b-d- fructofuranosyl)4 sucrose, 1F(1-b-d- fructofuranosyl)3-6G(1- b-d-fructofuranosyl) sucrose, 1F(1-b-d- fructofur-anosyl)-6G(1-b- d-fructofuranosyl)3 sucrose and 1F(1-b-d- fructofuranosyl)2-6G(1-b- d-fructofuranosyl)2 sucrose, F 6 Inulohexose 1.4 ± 0.2 GF 7 Heptafructooligosaccharide Tetrafructofuranosylnystose Heptasaccharides: 1F(1- 0.4 ± 0.2 (DP8) b-d-fructofuranosyl)5 sucrose F 7 Inuloheptose 1.7 ± 0.9 GF 8 Octafructooligosaccharide Pentafructofuranosylnystose 0.4 ± 0.2 (DP9) F 8 Inulooctose 0.5 ± 0.2 GF 9 Enneafructooligosaccharide Hexafructofuranosylnystose 0.5 ± 0.3   <4% (DP10) F 9 Inuloennea GF 10 Decafructooligosaccharide Pentafructofuranosylnystose 1 ± 1 F 10 Inulodeca GF> 10 (a) Tetrahedron: Asymmetry 16 (2005) 33-37 (b) International Journal of Food Science and Technology 2009, 44, 947-952 [0120] Table 4 below depicts oligofructose content of a preferred inulin composition that effectively synergize with sulfonylureas. [0000] TABLE 4 Oligofructose (OF) content of inulin Orafti P95 compositions (Analysed at the Australian Proteomic analysis facility). Percentage of each molecular composition of P95 Comp OF AVE SD DP2 F2 8.908464 0.452405 DP2 GF 4.873426 1.293211 DP3 F3 14.20397 0.486451 DP3 GF2 8.931783 0.288154 DP4 F4 16.19856 1.982083 DP4 GF3 3.279108 0.707716 DP5 F5 8.257493 0.791346 DP5 GF4 4.687028 0.74578 DP6 F6 0.800649 0.085048 DP2 F2 + GF 13.78 1.745542 DP3 F3 + GF2 23.14 0.25201 DP4 F4 + GF3 19.48 1.434588 DP5 F5 + GF4 12.94 1.532591 [0121] Table 5 and 6 below depict further examples of defined inulin preparations that effectively synergise with sulfonylureas. [0000] TABLE 5 Comparative content of oligosaccharides of defined inulin preparations including sc FOS and Sensus OFP (Oligofructose Preparation). scFOS 1 Theoretical FSANZ Component USA Special Orafti Sensus Inulin Inulin Designation Name GRAS Interest P95 OFP BP/USP & FOS GF 2 Ketose 5%  ~8% GF 3 Nystose 95% majority ~92% GF 4 Fructosylnytose GF 5 GF 6 GF 7 GF 8 GF 9 GF 10 GF >10 Short-Chain Fructo-oligo saccharides [0000] TABLE 6 Defined inulin preparation with proposed Australian Approved names “AAN”. Short Relative Hand AAN CAS conc. GF 2 Difructooligosaccharide (or Kestose) 470-69-9 4-8% GF 3 Trifructooligosaccharide (or Nystose) 13133-07-8 84-95% GF 4 Tetrafructooligosaccharide GF 5 Pentafructooligosaccharide GF 6 Hexafructooligosaccharide GF 7 Heptafructooligosaccharide GF 8 Octafructooligosaccharide GF 9 Enneafructooligosaccharide <5% GF 10 Decafructooligosaccharide GF> 10 [0122] For easy reference, a schematic diagram showing the relationship between inulin and FOS and the chemical structure of scFOS is found in FIG. 12 , which is publicly available information and can be found in biochemistry textbooks. Example 9 Methods of Preparing Inulin for Use in Compositions of the Invention Commercial Food-Grade Inulin Preparations [0123] Inulin preparations with desirable and advantageous DP values and/or with defined OF and/or FOS for use in the compositions of the invention may be obtained commercially. For example the OFP described in Example 8, Sensus OFP is manufactured and distributed by Sensus (Borchwerf 3, 4704 RG Roosendaal, The Netherlands). Commercial inulin preparations such as Sensus OFF are typically isolated as a mixture of oligoasaccharides by controlled enzymatic hydrolysis of inulin containing materials, e.g., plant materials, such as, chicory, artichoke and the like. A general overview of the process is shown in the schematic of FIG. 13 , which is publicly available on the Sensus website (http://www.sensus.nl/home-2.0.html). The manufacturing process has been developed and implemented at full commercial scale for a number of years, in line with EU food processing restrictions and requirements. In general, the process for producing Sensus OFP comprises harvesting chicory roots, extracting the sliced roots with hot water. The purification step removes solids and proteins. Thereafter, demineralisation/decolourisation takes place with known methods in the art. Further purification steps results in the final product which may be supplied as a syrup, or a powder, e.g., spray dried into a powder. A copy of the OFP product specification and the analytical method used for determining the degree of polymerisation of the product can be obtained from Sensus. The product supplied by Sensus can be stored for at least 5 years after production date, if stored in original sealed bags under dry conditions. [0124] Other native or modified enzymes may be used in any one of the processes described herein using inulin as a substrate. Such native or modified enzymes, include but are not limited to, levansucrase, 1,4-alpha-glucan 6-alpha-glycosyltransferase, 2,1-fructan: 2,1-fructan1-fructosyltransferase, inulinase, beta-fructofuranosidase, sucrose apha-glucosidase, 2,6-beta-fructan 6-levanbiohydrolase, fructan beta-fructosidase, fructan beta-92,1)-fructosidase, inulin fructotransferase (DFA-I-forming), inulin fructotransferase (DFA-II forming). Such enzymes can be readily found by searching a database, e.g., http://www.brenda-enzymes.info/). FOS Production: Lower DP Inulins [0125] FOS (inulins with a DP value less than 10 including the preferred forms F2 to F5) for use in the compositions of the invention may be purified from commercial preparations as described above, or similar OF preparations prepared using a method as described above. These processes also utilise native or modified enzymes as described above. [0126] FOS may be produced using any technology described in the art including digestion of substrates (21), as well as enzyme based synthesis from sub-units (22); processes using immobilised enzymes (23) and others that have specifically engineered reaction kinetics as key attributes (24) or use other platforms such as membranes for ordered manufacture (25) may also be used. Use of live organisms to monitor the progression of the reactions as described in (26) is also contemplated. [0127] A number of textbooks describe the production of FOS, the contents of which are incorporated by reference in their entirety (27). Catalytic systems are described, however, such systems require the use of co-factors such as divalent cations (Zn, Mg, Pb, Pt), as well as suitable modification and optimisation of reaction kinetics that will include, time, temperature, pH, substrate or reaction environmental selection. [0128] Synthetic strategies may also be used. Synthetic strategies described range from very basic theory to very advanced systems and include for example; application of strategic approaches including linear glycosylation, convergent block synthesis, single and multi-step strategies, Chemo-selective strategies, solid phase and combined semi-enzymatic methods. In some cases miniature reactors are used. More recent approaches have incorporated both laser and micro-wave mediated systems. [0129] Some of the more advanced systems have also used ‘Ionic catch and release methodology ( 28 ), HPLC assisted automated systems ( 29 ). Systems currently utilised in biofuels manufacture may also be adapted, these can include size reduction, chemical pre-treatment, cell lysis and enzymatic reactions. [0130] Systems including the isolation and utilisation of the enzymes that are specifically responsible for the degradation of high DP molecules into specific FOS, and ideally isolation and/or adaption of novel enzymes or organisms that capable of enhanced activity are also contemplated. Such enzymes may be from both prokaryotic and eukaryotic sources, with root vegetable sources being of particular interest. Such enzymes can be readily found by searching an online database, e.g., http://www.brenda-enzymes.info/). [0131] GF2, GF3 and GF4 may be prepared from sucrose using the enzyme β-fructofuranosidase essentially as described in reference (30) at pages 16 to 17. [0132] It is also contemplated that the Isolation of organisms and or enzymes that are capable of synthesising FOS of the desired DP, for example in a manner similar to dextrans may be used if they are available. Likely sources will include organisms that are known to exude extracellular polysaccharides, for biofilms (31) as well as yeasts (32), other organisms of interest include those that have demonstrable bifidogenic effect (33). Micro-organisms of particular interest will most likely be isolated or derived from extreme environments such as hot (thermophiles), low oxygen (anaerobic or facultative anaerobic), and/or low nutrient environments (for example pseudomonas). [0133] All processes relating to the determination of safety of ingesting FOS are published, e.g., as described in reference (30), the contents of which are incorporated by reference in their entirety. Example 10 Preparation of Unit Dosage Forms of Inulin Compositions [0134] The inulin preparations described herein, for example, any one of the OFP, FOS, or OF described in Examples 8 and 9, may be supplied directly as a solid or liquid oral dose form or manufactured as a formulation comprising actives and one or more pharmaceutically acceptable carriers, diluents or excipients as part of the manufacture of the dose form. The dose forms include, but are not limited to, liquids (spray, syrup, emulsion, suspension, paste, liquid extract of Chicory or other natural source of inulin, tonic, tincture etc) and including liquid filled capsules; as a semi-solid palatable gel, film, gum or wafer; as a solid form such as pastille, granules, powders, tablets (including chewable, dispersible, effervescent, coated, enteric, hard and soft capsules, etc). Other examples include transdermal, sublingual, injectable, implantable, bolus etc. Processing techniques known in the art maybe used, as well as known pharmaceutically acceptable carriers, diluents or excipients (see generally Remington's Pharmaceutical Sciences, (4) and e.g., references (5) to (20). To prepare such formulations, one or more inulin preparations of the invention described herein, are mixed with a pharmaceutically acceptable carrier or excipient for example, by mixing with physiologically acceptable carriers, excipients, or stabilizers in the form of, e.g., lyophilized powders, slurries, aqueous solutions, or suspensions. Broadly, pharmaceutically acceptable excipients, carriers or stabilizers that are used includes those that provide antioxidant, bulking, capsule lubricants, chelating, coating, colouring, complexing, desiccant, diluent, emollient, emulsification, film forming, flavours, glidant or anti-caking, humectant, sorbent, stiffening, sequestering, suspending, sweetening, tonifying, water repelling, wetting/solubilising etc. and as described in any one of references (4) to (20). [0135] In one example, tabletting is a solid dosage form that allows for preparation of individual and controlled dosage forms and supply with predictable characteristics over a wide range of parameters including: [0136] Dissociation, partitioning and solubility [0137] Release, dissolution and permeation and stability [0138] Commercial and identification parameters [0139] Palatability, dosage compliance, pack-ability etc. [0140] Considerations for designing a tablet inter alia, include: [0000] Quantity of active to be delivered per dose Desirable attributes of timing and delivery Stability or reactivity [0141] In addition to the general references cited above, further materials, as well as, tablet production and processing techniques and the like are set may be found in Chapter 1 (ref. 19), and Chapters 6, 8, 11 and 13 (ref. 20). For example, suitable excipients, carriers and/or other additives include capsule shells, fillers, desiccants, lubricants and binders and will typically include one or more of cellulose, colloidal anhydrous silica, hypromellose, lactose, lactose-monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch-maize, starch pre-gelatinised, stearic acid or talc. [0142] Other suitable excipients, carriers and/or other additives are provided below by way of non-limiting example. Those listed in bold are preferred. [0000] Acacia Acesulfame Potassium Acetic Acid, Glacial Acetone Acetyltriethyl Citrate Agar Albumin Alcohol Alginic Acid Aliphatic Polyesters Alitame Almond Oil Alpha Tocopherol Aluminum Hydroxide Adjuvant Aluminum Oxide Aluminum Phosphate Adjuvant Aluminum Stearate Ammonia Solution Ammonium Alginate Ascorbic Acid Ascorbyl Palmitate Aspartame Attapulgite Bentonite Benzalkonium Chloride Benzethonium Chloride Benzoic Acid Benzyl Alcohol Benzyl Benzoate Boric Acid Bronopol Butylated Hydroxytoluene Butylparaben Calcium Alginate Calcium Carbonate Calcium Phosphate Dibasic Anhydrous Calcium Phosphate, Dibasic Dihydrate Calcium Phosphate, Tribasic Calcium Stearate Calcium Sulfate Canola Oil Carbomer Carbon Dioxide Carboxymethylcellulose Calcium Carboxymethylcellulose Sodium Carrageenan Castor Oil Castor Oil, Hydrogenated Cellulose, Microcrystalline Cellulose, Powdered Cellulose, Silicified Microcrystalline Cellulose Acetate Cellulose Acetate Phthalate Ceratonia Cetostearyl Alcohol Cetrimide Cetyl Alcohol Cetylpyridinium Chloride Chitosan Chlorhexidine Chlorobutanol Chlorocresol Chlorodifluoroethane (HCFC) Chlorofluorocarbons (CFC) Chloroxylenol Cholesterol Citric Acid Monohydrate Colloidal Silicon Dioxide Coloring Agents Copovidone Corn Oil Cottonseed Oil Cresol Croscarmellose Sodium Crospovidone Cyclodextrins Cyclomethicone Denatonium Benzoate Dextrates Dextrin Dextrose Dibutyl Phthalate Dibutyl Sebacate Diethanolamine Diethyl Phthalate Difluoroethane (HFC) Dimethicone Dimethyl Ether Dimethyl Phthalate Dimethyl Sulfoxide Dimethylacetamide Disodium Edetate Docusate Sodium Edetic Acid Erythorbic Acid Erythritol Ethyl Acetate Ethyl Lactate Ethyl Maltol Ethyl Oleate Ethyl Vanillin Ethylcellulose Ethylene Glycol Palmitostearate Ethylene Vinyl Acetate Ethylparaben Fructose Fumaric Acid Gelatin Glucose, Liquid Glycerin Glyceryl Behenate Glyceryl Monooleate Glyceryl Monostearate Glyceryl Palmitostearate Glycofurol Guar Gum Hectorite Heptafluoropropane (HFC) Hexetidine Hydrocarbons (HC) Hydrochloric Acid Hydroxyethyl Cellulose Hydroxyethylmethyl Cellulose Hydroxypropyl Cellulose Hydroxypropyl Cellulose, Low-substituted Hydroxypropyl Starch Hypromellose Hypromellose Acetate Succinate Hypromellose Phthalate Imidurea Inulin Iron Oxides Isomalt Isopropyl Alcohol Isopropyl Myristate Isopropyl Palmitate Kaolin Lactic Acid Lactitol Lactose, Anhydrous Lactose, Monohydrate Lactose, Spray-Dried Lanolin Lanolin Alcohols Lanolin Hydrous Lauric Acid Lecithin Leucine Linoleic Acid Macrogol 15 Hydroxystearate Magnesium Aluminum Silicate Magnesium Carbonate Magnesium Oxide Magnesium Silicate Magnesium Stearate Magnesium Trisilicate Malic Acid Maltitol Maltitol Solution Maltodextrin Maltol Maltose Mannitol Medium-chain Triglycerides Meglumine Menthol Methylcellulose Methylparaben Mineral Oil Light Mineral Oil and Lanolin Alcohols Monoethanolamine Monosodium Glutamate Monothioglycerol Myristic Acid Neohesperidin Dihydrochalcone Nitrogen Nitrous Oxide Octyldodecanol Oleic Acid Oleyl Alcohol Olive Oil Palmitic Acid Paraffin Peanut Oil Pectin Petrolatum Petrolatum and Lanolin Alcohols Phenol Phenoxyethanol Phenylethyl Alcohol Phenylmercuric Acetate Phenylmercuric Borate Phenylmercuric Nitrate Phosphoric Acid Polacrilin Potassium Poloxamer Polycarbophil Polydextrose Polyethylene Glycol Polyethylene Oxide Polymethacrylates Poly(methyl vinyl ether/maleic anhydride) Polyoxyethylene Alkyl Ethers Polyoxyethylene Castor Oil Derivatives Polyoxyethylene Sorbitan Fatty Acid Esters Polyoxyethylene Stearates Polyvinyl Acetate Phthalate Polyvinyl Alcohol Potassium Alginate Potassium Benzoate Potassium Bicarbonate Potassium Chloride Potassium Citrate Potassium Hydroxide Potassium Metabisulfite Potassium Sorbate Povidone Propionic Acid Propyl Gallate Propylene Carbonate Propylene Glycol Propylene Glycol Alginate Propylparaben 2-Pyrrolidone Raffinose Saccharin Saccharin Sodium Saponite Sesame Oil Shellac Simethicone Sodium Acetate Sodium Alginate Sodium Ascorbate Sodium Benzoate Sodium Bicarbonate Sodium Borate Sodium Chloride Sodium Citrate Dihydrate Sodium Cyclamate Sodium Hyaluronate Sodium Hydroxide Sodium Lactate Sodium Lauryl Sulfate Sodium Metabisulfite Sodium Phosphate Dibasic Sodium Phosphate Monobasic Sodium Propionate Sodium Starch Glycolate Sodium Stearyl Fumarate Sodium Sulfite Sorbic Acid Sorbitan Esters (Sorbitan Fatty Acid Esters) Sorbitol Soybean Oil Starch Starch Pregelatinized Starch Sterilizable Maize Stearic Acid Stearyl Alcohol Sucralose Sucrose Sugar, Compressible Sugar, Confectioner's Sugar Spheres Sulfobutylether b- Cyclodextrin Sulfuric Acid Sunflower Oil Suppository Bases, Hard Fat Talc Tartaric Acid Tetrafluoroethane (HFC) Thaumatin Thimerosal Thymol Titanium Dioxide Tragacanth Trehalose Triacetin Tributyl Citrate Triethanolamine Triethyl Citrate Vanillin Vegetable Oil, Hydrogenated Water Wax, Anionic Emulsifying Wax, Carnauba Wax, Cetyl Esters Wax, Microcrystalline Wax, Nonionic Emulsifying Wax, White Wax, Yellow Xanthan Gum Xylitol Zein Zinc Acetate Zinc Stearate Tabletting Process: [0143] By way of non-limiting example, tablets according the following schedule were produced: [0000] Raw materials Claim/Label mg/tablet Batch Inulin powder** 1500 1500 mg 702.33 g  Sodium starch glycollate  63 mg 29.5 g Magnesium stearate   8 mg 3.75 g Total tablet weight 1571 mg **The inulin powder in the above schedule includes one of the inulin preparations of the invention, for example, any one of the OFP, FOS, or OF described in Examples 8 and 9. Tablets including Sensus brand OFP were prepared. [0144] It is noted that both sodium starch glycolate and magnesium stearate are routinely included as excipients in tablets formulated for management of type 2 diabetes; including those with sulfonylurea as an active ingredient. There are no reported interactions between Inulin (or fructo oligosaccharides) and any of the proposed excipients, each of which are included in a number of pharmacopeia and are recognised as excipient ingredients. [0000] Sodium Starch Glycolate 63 mg (4% w/w) [0145] There are a number of different variants of cross linked Sodium Starch Glycolate, each of which are prepared from potato starch. It is used as a disintergrant in tablet and capsule manufacture. This excipient is considered to be chemically stable and is chemically incompatible with ascorbic acid. There are reported pharmacological interactions between sodium starch glycolate and glycopeptide antibiotics and basic (alkaline) drugs. References (11), (13), (14) and (15) contain additional pharmacopeial data pertaining to this substance. The concentration used is considered to be optimal with typical concentrations quoted as being between 2 and 8%. [0000] Magnesium Stearate 8 mg (0.5% w/w) [0146] Magnesium stearate is a compound that acts as a lubricant in tabletting and encapsulation regimes comprised of solid organic acids (stearate and Palmitate) and magnesium. The specific surface area is an important characteristic in the suitability to various dose forms and must be determined for batch to batch consistency. It has the molecular formula C 36 H 70 MgO 4 (5911.34 and the structural formula [CH 3 (CH 2 ) 16 COO] 2 Mg. While chemically stable it is considered incompatible with strong acids, strong alkalies and iron salts. It cannot be used in conjunction with products containing aspirin, some vitamins and most alkaloid salts. References (11), (13), (14) and (15) contains additional Pharmacopeial data about this substance. The concentration quoted is considered to be appropriate, with typical concentrations between 0.25 and 5% w/w. [0147] An example of the tabletting process is described. Typically doses are manufactured using the following regimes. [0148] Materials preparation [0149] Dose form assembly [0150] Quality control and packaging [0151] Materials preparation initially includes inspecting each of the substances for suitability for intended use and quantitatively dispensing known amounts of each of the excipients. This is followed by screening, a process whereby ingredients are passed through a physical screen or past a screening device that identifies and/or removes particulates that are not conducive to preparing a uniform dosage form. Screening can be manual, semi-automatic or fully automatic process. Other control steps such as metal detection or sampling and QC analysis of starting materials can also be employed at this stage. [0152] Materials preparation can also include milling, a process whereby products are reduced or standardised in size; typically, this may be undertaken in conjunction with other processes, for individual ingredients and/or for blends. Milling helps to ensure uniformity, and may be applied in a variable manner, depending on the physical nature of the ingredients. Milling is achieved using any known process in the art and includes the use of equipment including choppers, hammer mills, grinder, vertical impact, high shear, ball mills (etc). [0153] To prepare the active ingredient for division into discrete dosage forms, blending may be used. Blending may be performed at sub-batch, batch or as a continuous process and will typically employ the physical mixing and agitation of known amounts of ingredient materials. In commercial preparations the products are typically automated, and can include wet and dry blending. [0154] Dry blending typically applies a turbulent process, such as tumbling, ribbon blending, vibration and similar regimes. The nature duration of mixing will be dependent on the flow characteristics of the materials, the range in particulate size, the hydration of the materials, the specific absorption profiles of the formulations and the prevailing material and environmental conditions. [0155] Often pre-blending or pre-compression activities such as ‘granulation’ are also employed. Granules can be prepared using methods such as wet or dry granulation, fluid bed granulation, moisture activated dry granulation, spray drying and the like. Fluids can include for example; water, tinctures or solvents, steam or melted components. Where moisture or fluids are employed, they are typically removed from the granulated mass by means of heat, vacuum, hot air, dehydration, desiccation, setting, aging and the like. [0156] Following ingredients preparation, tablets are compressed into their dosage form. Typically this process is highly automated; using ‘presses’ that compress measured amounts of granules or powder between ‘dies’. These die comprise two complementary pieces that meet under pressure and thereby compress the preparation into tablets of pre-defined size, shape, hardness and friability. Pneumatic, hydrolytic and mechanical compression can be used. [0157] Typically compressed tablets are de-dusted by tumbling, brushing, vacuum or the like. [0158] Following compression, and if merited by the design of the dose form tablets may be coated using a suitable coating substance, this can be for the purpose of colouring, smoothing, modifying the taste, stability or digestion characteristics of the solid dosage form. De-dusted tablet ‘cores’ are tumbled and then sprayed or otherwise coated with a liquid or liquefied coating material that is applied evenly across the outer-surface of the tablet cores, usually in several layers or as an extended process, and then allowed to dry. [0159] Tablets or coated tablets are inspected either manually or electronically for defects. The content, physical characteristics, and predictable biochemical attributes are assessed using assay, evaluation and related QC. [0160] Examples of the Physical Parameters tested, e.g., for the tablets produced according to the above Schedule are as follows: [0000] Test Acceptable Range Ref Method(s) Colour & Appearance (colour) Shape (describe) Dimensions (quantity) Average Mass/ 1571 mg *BP Appendix XII C Uniformity of mass +/−5% = 1492.45 to Weigh individually 20 units taken at 1649.55 mg random and determine the average +/−10% = 1413.9 to mass. NMT 2 of the individual 1728.1 mg masses deviate from the average mass by more than 5% and none deviates by more than 10%. Dissolution Not more than 30 minutes *BP Appendix XII B Conventional release solid dosage forms Friability Not more than 1% weight *BP Appendix XVII G loss Uncoated Tablets Breaking Force (to be determined) Max **USP/*BP and Min newtons of 6 tablets Uniformity of Dosage Content Uniformity of 30 *BP Appendix XII C from tablets *BP-British Pharmacopeia (ref. 11). **USP-US Pharmacopeia (ref. 13). [0161] Bulk tablets are then packed into suitable matching that can include, blisters, bottles, dispensers etc. Any packaging and labelling may be used provided it is suitable for maintaining the identity, integrity and efficacy of the products. Example 11 Inulin Containing Unit Dosage Formulations of Sulfonylureas [0162] Unit dosage forms of any one of the inulin preparations of the invention and sulfonylurea may be easily derived from the information provided in the tables 7 to 12 below, which provide, by way of non-limiting examples only, the various quantities and relative proportions of inulins and sulfonylureas. The information provided in the tables is approximate and it will be understood from the data provided that unit dosage forms may contain quantities of inulins and sulfonylurea so as to achieve effective treatment when administered to the patient from one to several time per day. Desirably, unit dosage forms, such as tablets, capsules or similar, are formulated so as to allow e.g., 2 to 4 unit dosage forms to be taken 2 to 3 times daily. Thus, the unit dosage form may contain a sulfonylurea in the amount from about 0.5 to about 2000 mg, or as described herein above. The amount of sulfonylurea in the unit dosage form may vary with the type of sulfonylurea used and treatment regimen required, both of which can be easily determined by a medical practitioner. The absolute quantity of inulin per dosage form will depend on the inulin used and, if being compressed into a tablet dosage form, on compressibility of inulin so as to provide for an acceptable size tablet. The quantity of inulin may range from about 5 mg to about 50 grams per dosage form, or as described herein above. A suitable dosage form may be, for example, a tablet comprising 500-1000 mg of inulin and 1 to 30 mg sulfonylurea (but may be higher depending on the type of sulfonylurea used). Three to four such dosage forms may be taken 3 times daily to achieve effective treatment (eg. lowering of blood glucose level). The quantity of each ingredient may be greater if compressibility of inulin used allows it in order to achieve a suitably sized dosage form. [0000] TABLE 7 Molecular characteristics of selected sulfonylureas and sugar monomers gr/mole mmole C 6 H 12 O 6 Glucose Mw 180.15588 C 6 H 12 O 6 Fructose Mw 180.15588 C 23 H 28 ClN 3 O 5 S Glibenclamide 494.004 15 mg daily (3x) = 0.030364 C 15 H 21 N 3 O 3 S Gliclazide 323.412 30 mg daily (1x)= 0.092761 C 24 H 34 N 4 O 5 S Glimepiride 490.617  4 mg daily (1x) = 0.008153 C 21 H 27 N 5 O 4 S Glipizide 445.536 15 mg daily (3x)= 0.033667 [0000] TABLE 8 Inulin/Glibenclamide 12 gram/15 mg per day Ratio (w/w) MW Lowest Highest Inulin/Glib Inulin/Glib gr/mole (gr)* (gr)* Lowest Highest F3 540.47 2532 3336 169 222 GF2 540.47 168 324 11 22 F4 720.62 2052 2760 137 184 GF3 720.62 468 756 31 50 F5 900.78 1044 1572 70 105 GF4 900.78 660 1140 44 76 F6 1080.94 660 1044 44 70 GF5 1080.94 708 1008 47 67 F3 + F4 + F5 = 5628 7668 375 511 15 gram/15 mg per day Ratio (w/w) MW Lowest Highest Inulin/Glib Inulin/Glib gr/mole (gr)* (gr)* Lowest Highest F3 540.47 3165 4170 211 278 GF2 540.47 210 405 14 27 F4 720.62 2565 3450 171 230 GF3 720.62 585 945 39 63 F5 900.78 1305 1965 87 131 GF4 900.78 825 1425 55 95 F6 1080.94 825 1305 55 87 GF5 1080.94 885 1260 59 84 F3 + F4 + F5 = 7035 9585 469 639 [0000] TABLE 9 Inulin/Gliclazide 12 gram/30 mg per day Ratio (w/w) MW Lowest Highest Inulin/Glic Inulin/Glic gr/mole (gr)* (gr)* Lowest Highest F3 540.47 2532 3336 84 111 GF2 540.47 168 324 6 11 F4 720.62 2052 2760 68 92 GF3 720.62 468 756 16 25 F5 900.78 1044 1572 35 52 GF4 900.78 660 1140 22 38 F6 1080.94 660 1044 22 35 GF5 1080.94 708 1008 24 34 F3 + F4 + F5 = 5628 7668 188 256 15 gram/30 mg per day Ratio (w/w) MW Lowest Highest Inulin/Glic Inulin/Glic gr/mole (gr)* (gr)* Lowest Highest F3 540.47 3165 4170 105.5 139 GF2 540.47 210 405 7 13.5 F4 720.62 2565 3450 85.5 115 GF3 720.62 585 945 19.5 31.5 F5 900.78 1305 1965 43.5 65.5 GF4 900.78 825 1425 27.5 47.5 F6 1080.94 825 1305 27.5 43.5 GF5 1080.94 885 1260 29.5 42 F3 + F4 + F5 = 7035 9585 235 320 [0000] TABLE 10 Inulin/Glimepiride 12 gram/4 mg per day Ratio (w/w) MW Lowest Highest Inulin/Glim Inulin/Glim gr/mole (gr)* (gr)* Lowest Highest F3 540.468 2532 3336 633 834 GF2 540.468 168 324 42 81 F4 720.624 2052 2760 513 690 GF3 720.624 468 756 117 189 F5 900.779 1044 1572 261 393 GF4 900.779 660 1140 165 285 F6 1080.935 660 1044 165 261 GF5 1080.935 708 1008 177 252 F3 + F4 + 5628 7668 1407 1917 F5 = 15 gram/4 mg per day Ratio (w/w) MW Lowest Highest Inulin/Glim Inulin/Glim gr/mole (gr)* (gr)* Lowest Highest F3 540.468 3165 4170 791 1043 GF2 540.468 210 405 53 101 F4 720.624 2565 3450 641 863 GF3 720.624 585 945 146 236 F5 900.779 1305 1965 326 491 GF4 900.779 825 1425 206 356 F6 1080.935 825 1305 206 326 GF5 1080.935 885 1260 221 315 F3 + F4 + 7035 9585 1758.75 2396.25 F5 = [0000] TABLE 11 Inulin/Glipizide 12 gram/15 mg per day Ratio (w/w) MW Lowest Highest Inulin/Glip Inulin/Glip gr/mole (gr)* (gr)* Lowest Highest F3 540.47 2532 3336 169 222 GF2 540.47 168 324 11 22 F4 720.62 2052 2760 137 184 GF3 720.62 468 756 31 50 F5 900.78 1044 1572 70 105 GF4 900.78 660 1140 44 76 F6 1080.94 660 1044 44 70 GF5 1080.94 708 1008 47 67 F3 + F4 + F5 = 5628 7668 375.2 511.2 15 gram/15 mg per day Ratio (w/w) MW Lowest Highest Inulin/Glip Inulin/Glip gr/mole (gr)* (gr)* Lowest Highest F3 540.47 3165 4170 211 278 GF2 540.47 210 405 14 27 F4 720.62 2565 3450 171 230 GF3 720.62 585 945 39 63 F5 900.78 1305 1965 87 131 GF4 900.78 825 1425 55 95 F6 1080.94 825 1305 55 87 GF5 1080.94 885 1260 59 84 F3 + F4 + F5 = 7035 9585 469 639 *The “lowest (gr)” and “highest (gr)” values are based on the variable content of the specified OF in the inulin preparations. [0000] TABLE 12 Summary of useful sulfonylurea/inulin weight and molar ratios for selected formulations Composition Weight Ratio Molar Ratio Glibenclimide:Inulin 1:375 to 1:639 1:286 to 1:484 Gliclazide:Inulin 1:188 to 1:320  1:94 to 1:158 Glimepiride:Inulin 1:1407 to 1:2396 1:1066 to 1:1801 Glipizide:Inulin 1:375-1:639 1:258-1:436 [0163] A person skilled in the art will understand that the above ratio will change depending on the form of inulin used, as the above molar ratios are calculated using Sensus OFP. Accordingly, the ratios will differ with higher efficacy inulin forms and discrete pure oligos. A person skilled in the art will understand how to calculate such ratios based on the dosage used of each component. Example 12 Clinical Trial [0164] Clinical trials are performed according to the parameters described herein to assess the efficacy of different doses of inulin and/or FOS preparations on glycemic control in patients with T2DM. The inulin and/or FOS preparation may be any preparation of inulin and/or FOS including unit dosage forms suitable for this purpose, e.g., as described in any one of the Examples, referred to as “inulin-preparation”. At least one clinical trial including a purified food grade inulin-preparation that comprises the OF content as described in Table 4 or Table 6 is used. In another clinical trial, ORAFTI P95 is used. In another clinical trial Sensus OFP is used. Briefly, the clinical trial includes individuals who are exclusively treated with second generation sulfonylurea (preferably with glibenclamide, gliclazide, glimepiride and glipizide) monotherapy and have uncontrolled blood glucose levels. The effect of the inulin-preparation on end-point parameters such as (i) fasting blood glucose levels (FGL), (ii) haemoglobin A1c (HA1c) and (iii) weight is assessed. Other diabetes related markers such as (iv) post prandial glucose levels (PPGL), (v) fructoseamine, (vi) glucagon-like peptide 1 (GLP-1) and (vii) blood insulin levels is assessed. Variables such as the number of hypoglycaemic episodes, patient's activity status, satiety, patient's quality of life, stool microflora, circulating lipo-polysaccharide (LPS), haematology, biochemistry, lipid profiles, erythrocyte sedimentation rate, C reactive protein, echocardiography and ophthalmic conditions of the patients is also assessed. Pharmacokinetic and pharmacodynamic of the inulin preparation and sulfonylurea, as well as, safety and tolerability of combination of the inulin preparation and sulfonylurea is also assessed. The effect of addition of the inulin preparation on absorption, distribution, metabolism and excretion of sulfonylurea is determined. [0165] Four treatment groups consisting of 9 patients per group (total 36 patients) are to be enrolled in this trial. For each group, patients are randomized depending on their gender, age, body mass index and genetic background. Patients with baseline FGL of above 7 mmol/L are recruited. Group 1 is the control group and are given sulfonylurea anti-diabetics for the entire trial. Group 2 consists of patients on sulfonylurea and taking the inulin preparation at 3×1.5 grams (4.5 grams/day) doses. Group 3 consists patients on sulfonylurea and taking inulin preparation at 6×1.5 grams (9 grams/day) doses. Group 4 consists of patients on sulfonylurea and taking inulin preparation at 9×1.5 grams (13.5 grams/day) doses. Initially each group is treated with the recommended doses. In the event that after 12 weeks of treatment, any patient showing no improvement on his/her FGL then the inulin preparation dose is increased by 4.5 grams/day increments for the following 12 weeks (Table 9). The maximum daily doses of inulin preparation used in this trial are below the regulatory authorities (e.g. FSANZ and TGA, FDA) recommended average maximum daily doses for consumption by healthy individuals ( 41 grams/day). This treatment regime tests several doses and preparations of inulin and/or FOS on various patient populations. [0000] TABLE 13 Combination trial dosage regimen. Treatments Dosage of inulin and/or FOS preparation (grams/day) Patients Sulfonylurea At the start of At the start of At the start of Groups At recommended dosage week 12 week 28 week 44 Max dosage 1 Any second generation 0 0 0 0 2 Any second generation 4.5 4.5-9 4.5-13.5 13.5 3 Any second generation 9   9-13.5 9-18 18 4 Any second generation 13.5 13.5-18 13.5-22.5  22.5 [0166] Although the invention has been described with reference to specific embodiments it will be understood that variations and modifications in keeping with the principles and spirit of the invention described are also encompassed. REFERENCES [0000] 1. Bornet F R J (1994) Undigestible sugars in food products. American Journal of Clinical Nutrition 59, 763S-769S. 2. De Leenheer L (1996) Production and use of inulin: Industrial reality with a Promising future. In Carbohydrates as Organic Raw Materials III, pp. 67-92 [H Van Bekkum, H Ro{umlaut over ( )}per and A G J Voragen, editors]. New York, N.Y.: VCH Publishers Inc. 3. Csanadi, Z S and Sisak C S (2008) Production of short chain fructooligosaccharides. Hungarian Journal of Industrial Chemistry, Vol 36(1-2), pp. 23-26 4. Remington's Pharmaceutical Sciences (2000), Mack Publishing Company, Easton, Pa., USA 20.sup.th Edition, 2000 5. Hardman, et al. (2001) Goodman and Gilman's The Pharmacological Basis of Therapeutics, McGraw-Hill, New York, N.Y. 6. Gennaro (2000) Remington: The Science and Practice of Pharmacy, Lippincott, Williams, and Wilkins, New York, N.Y. 7. Avis, et al. (eds.) (1993) Pharmaceutical Dosage Forms: Parenteral Medications, Marcel Dekker, NY 8. Lieberman, et al. (eds.) (1990) Pharmaceutical Dosage Forms: Tablets, Marcel Dekker, NY 9. Lieberman, et al. (eds.) (1990) Pharmaceutical Dosage Forms: Disperse Systems, Marcel Dekker, NY 10. Weiner and Kotkoskie (2000) Excipient Toxicity and Safety, Marcel Dekker, Inc., New York, N.Y. 11. British Pharmacopeia (2011), The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA). 12. Rowe, at al. (eds.) (2006) Handbook of Pharmaceutical Excipients, Buttler & Tanner, Frome Somerset, Great Britain. 13. United States Pharmacopeia, (2012), US Pharmacopeial Convention. 14. Japanese Pharmacopeia, Fifteenth Edition (2006), Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. 15. Sweetman S (ed.)(2007), Martindale: The Complete Drug Reference, Pharmaceutical Press, London 16. Maryadele et al. (eds.)(2006), The Merck Index, Merck Research Laboratories, Merch & Co., Inc. NJ, USA. 17. Katdare and Chaubal (eds.)(2006), Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems, Informa Health Care, USA 18. Niazi (ed)(2007), Handbook of Preformulation, Chemical, biological, and Botanical Drugs, Informa Health Care, USA 19. Parikh (ed)(2010), Handbook of Pharmaceutical Granulation Technology, Informa Healthcare, USA 20. First Edition (2009), Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Elsevier Inc., USA 21. Ichikawa et al. (1992), Analytical Biochemistry 202: pp 215-238 22. Singh and Singh ( 2010 ), Food Technol. Biotechnol. 48 ( 4 ): pp 435-450. 23. Nguyen et al. (2011), Process Biochemistry 46: pp 298-303. 24. Siebel et al. (2009), Adv. Biochem Engin/Biotechnol 54, Extending Synthetic Routes for Oligosaccharides by Enzyme, Substrate and Reaction Engineering. 25. Olano-Martin et al. (2001), Journal of Food Science, 66 (7): pp 966-971. 26. Kaplan and Hutkins (2012), Appl. Environ. Microbiol. 66(6):2682-2684. 27. Polaina and MacCabe (eds.)(2007), Industrial Enzymes, Structure, Function and Applications, Springer, The Netherlands. 28. Tran et al. (2011), Chem. Commun., 47: pp 4526-4528. 29. Ganesh et al. (2012), Organic Letters, 14(12): pp 3036-3039. 30. Generally Recognised as Safe Notification for Short-Chain Fructooligosaccharide (2000), prepared for GTC Nutrition Company Golden Colorado, Prepared by Environ International Corporation Arlington, Va. 35. Harrah et al. (2006), Prokaryotes, 1: pp 766-776. 36. Pavlova et al. (2009), Folia Microbiol. 54 (4): pp 343-348. 37. Meyer and Stasse-Wolthuis (2009), European Journal of Clinical Nutrition, 63: pp 1277-1289.

1a

FIELD OF THE INVENTION [0001] The present invention is related to a device and method for marking, localizing and tracing the absolute position, motion and/or distortion of organs and regions or voids in organs, particularly in flexible tissue in human and animal subjects. The invention is further related to methods of use of the device of the invention. STATE OF THE ART [0002] Interstitial markers are used in many medical applications for localizing and following-up regions of body. [0003] A first typical application of interstitial markers is in the following context: a tissue abnormality is detected by a known diagnostic tool, such as ultrasonography, PET, SPECT, CT scan, mammogram, radiography or manual palpation. The diagnostic tool does not allow making a distinction between a malignant and a benign tumor. A biopsy is performed in order to analyze the tumor. A marker is then inserted at the location of the biopsy, for later precise treatment of the tumor, if necessary. Breast cancer diagnosis and treatment require such markers. [0004] In another application, interstitial markers are also used for preparing patients undergoing radiation treatment such as proton beam, electron beam or x-ray treatments. Such treatments are usually split in a sequence of daily sessions or fractions. A treatment might for example be delivered in 25 days, each giving a dose of 3 Gy. In order to precisely position the patient with respect to the irradiation source, it is necessary to have markers that are visible to the eye or to an X-ray imaging system. For tumors that are in a fixed position with respect to bone structures, e.g. tumors in the brain, these bone structures can be used as markers. However, for soft tissues, which are not in a fixed position with respect to bone structures, these markers are of no avail. This is the case for the breast and the prostate, for which it has been determined that average movement may be as large as 30 mm. With irradiation techniques such as proton or heavy ion therapy or IMRT allowing 3D conformation of the applied dose to the target tumor, a marker and method for marking are needed for aligning the tumor to be treated with the treatment beam. Irradiation techniques have been improved, and accuracy better than 1 mm in beam spatial position is now state of the art so a corresponding precision in patient positioning is required. [0005] In still another application, there is a need for means for following up the growth or decrease in size of a tumor. With the known interstitial markers, such as seeds, it is possible to follow the position of the markers, and hence of the organ in which they are embedded. It is however not possible to follow the change of shape of said organ. Typical seeds do move 2-3 mm on average from the position to which they were deployed. Marker migration cannot be distinguished from organ displacement or distortion. Fundamentally, with point markers, clinicians are left to impute the behavior of the tissue between two or more markers. There is typically no detailed knowledge of the behavior of the tissue between the markers. This can lead to misinterpretation of the target volume change or deformation if the tissue or organ is being subjected to either external or internal forces. [0006] It has been determined that, for the treatment of some cancers such as prostate cancers, a combination of several treating methods produces the best results. In prostate cancer therapy, a combination of brachytherapy, i.e. inserting radioactive implants into the organ, and external beam therapy give good results. The brachytherapy implants traditionally used are seeds having the shape and size of a grain of rice. However, such seeds have two drawbacks: they can drift away from their intended location, and they give poor visibility to ultrasound imaging. [0007] The need for an interstitial marker appears in the diagnosis and treatment of cancers such as breast and prostate cancer. It is preferred that these markers be readily visible to the imaging techniques used. They must therefore be visible to X-rays, used in the mammogram. They also must be visible under ultrasonoscopy or ultrasonography, and therefore have a good “echogenicity”, i.e. reflect ultrasounds. [0008] Document U.S. Pat. No. 5,221,269 discloses a marker wire for localizing a breast lesion. The marker wire is made of a superelastic material, and preformed into a helical coil configuration. The marker wire is introduced trough a tubular needle, straightened out, and regains its helical shape when pushed out of the needle. The diameter of such coil is typically 3 cm, and the wire used has a diameter of 300 μm. The proximal end of the wire, when the marker is installed, appears at skin level. This marker can therefore only be used for short term marking, between biopsy and treatment, and may not be left permanently in the body. The distal end of the needle used for introduction may include a plurality of semispherical indentations in order to enhance the ultrasound visibility. [0009] Document U.S. Pat. No. 5,234,426 discloses a marker made from a shaft, and having, at its distal end, a helicoidally wound wire. The wire has a diameter of between 0.009 and 0.015 inches (between 200 and 400 μm). This marker, when positioned, also has a proximal end protruding from the patient's body. [0010] Document U.S. Pat. No. 6,228,055 discloses i.a. the use of embolization coils as marker. Embolization coils are designed for permanent placement into veins or arteries for curing of vascular lesions or malformations. Such intraluminal devices have an external diameter adapted to the vessel to be treated, typically of the order of magnitude of 0.5 to 5 mm, and made of a material and size giving sufficient mechanical strength to perform their function. Document WO 02/41786 also discloses the use of an embolization coil as a biopsy marker. These devices have, as a result of their size and rigidity, many drawback for use as interstitial markers: (i) they can not be introduced through a minimally invasive intervention, such as a fine needle; (ii) they may not be readily accepted as permanent marker, left in the body, in case the biopsy does not reveal the tumor to be malignant; (iii) they lack the lateral and axial flexibility that is required for permanent insertion in soft tissues that may shrink or swell under the influence of outside factors; (iv) they may mask and conceal features of the lesion that should remain visible to the therapist. [0011] For marking biopsy sites, e.g. for breast biopsies, it is known to use clips, such as the one disclosed in document U.S. Pat. No. 6,425,903. The placement of a set of such clips does not allow the follow-up of the shape of the cavity. It is also known to use a combination of a filler body, and a detectable marker, as know from document U.S. Pat. No. 6,356,782. The presence of a filler body may not improve the healing process of the biopsy site. [0012] Through the development of medical imaging techniques, such as digital X-ray radiography, mammography, CT (computerised tomography) scan, MRI(magnetic resonance imaging), Ultrasonography, PET (positron emission tomography)scan, means for detecting detailed features of organs and tumors are now available. Each of these techniques have their advantages, drawbacks and preferred fields of application. Spatial resolution, capability of tissue differentiation, trauma to the patient, speed and cost may vary. It is therefore desirable to be able to reconcile data obtained from these different imaging techniques, or from images taken through the same techniques from different angles and or at different times. A method for fusion of images obtained through x-rays and ultrasound is known from document U.S. Pat. No. 5,810,007. In this method, the fiducials (reference points) used for superposing both images are part of the ultrasound probe. The precision of the process relies on the precise location of the ultrasound probe, and cannot be used to fuse images taken at different times, the ultrasound probe, being removed. [0013] It is therefore an object of the present invention to provide a marker that is small and flexible enough to be permanently left in the patient body, that can be inserted through a minimally invasive technique, that can show organ change of shape, and that is readily visible under imaging techniques, including x-ray and ultrasound, during and after insertion. [0014] It is another object of the present invention to provide method for precisely localising an organ or tumor to be treated with a radiation beam, and a marker adapted for use in said method. [0015] It is still another object of the present invention to provide a method for following-up the location, change of size of an organ or tumor, and a marker adapted for use in said method. [0016] It is also an object of the present invention to provide a method of image fusion, and a marker adapted for use in said method. SUMMARY OF THE INVENTION [0017] The present invention is related, in one aspect, to an interstitial marker for localizing an organ, tumor or tumor bed within a mammalian body. The marker has a proximal end, a distal end, and a continuous intervening length. At least a portion of the intervening length is visible under at least one imaging modality and has a flexibility such that said marker follows movements and changes of shape of said organ, tumor or tumor bed. In a preferred embodiment, the interstitial marker has a ratio of said length to its diameter of 10 or higher. Depending on the application, said ratio may even be of 250 or higher. The interstitial marker may comprise a flexible wire, and said wire may be in form of a helical coil, whereby an advantageous flexibility is obtained. The helical coil marker may comprise sections of different pitch. Sections of different pitch have different characteristics as to visibility under different imaging modalities, and also have different mechanical characteristics as to longitudinal and lateral flexibility. At least portions of the marker may be made of a radiopaque material. They may be visible under diagnostic x-ray imaging, eg x-rays having an energy in the range of 100 keV. They may also advantageously be visible under higher energy x-rays used in treatment beams, eg x-rays in the range of 3 to 50 MeV. They also preferably may be visible under ultrasound imaging. The marker may include one or more tissue anchors at opposite ends thereof, and/or at intermediate points to fix the marker in the organ, tumor or tumor bed. The marker will thereby follow changes of size and shape, especially longitudinal size changes. Other means for anchoring to said organ, tumor or tumor bed may be used, e.g. a structure of the lateral surface of the marker improving the grip of the marker to the tissue, such as the ridges on the outer surface of an helical coil. The marker is preferably made of a biocompatible material suitable for permanent implantation. Such material may be rhodium, platinum, iridium, tantalum, titanium, silver, gold, nickel, alloys containing these metals and stainless steel. [0018] According to another aspect of the invention, method is provided for treating a soft tissue organ, tumor or tumor bed of a patient with a radiation beam, using a beam delivery setup, wherein a prescribed dose is delivered in one or more fractions. One inserts one or more markers of the invention in the organ, tumor or tumor bed. One then roughly positions the patient for receiving the radiation beam and then forms an image of the marker or markers under an imaging modality, eg x-ray image. From the image or images, one can infer the exact position, shape and change of shape of said organ, tumor or tumor bed. One can then adjust patient position and/or radiation beam delivery setup in order to direct the radiation beam towards the organ, tumor or tumor bed, and delivering the treatment beam exactly to the precise organ location, size or orientation. If the prescribed dose is to be delivered in successive fractions, one can repeat the above steps, adapting each time the patient position and beam delivery setup according, when the organ to be treated changes position, size and/or orientation during the treatment. [0019] A further aspect of the invention is related to a method of determining the change of shape, size or location of an organ, tumor or tumor bed. One or more markers of the invention are inserted in the organ, tumor, or tumor bed. The markers have flexibility such that they follow movements and changes of shape of the organ, tumor or tumor bed. The length of the marker may be chosen according to the size of the organ, tumor or tumor bed to be followed. Successive images of the organ are taken. From the change of shape or position of said markers, one infers the change of shape, size or location of the organ, tumor or tumor bed. [0020] In a further aspect of the invention, a method comprises the insertion of two or more markers in said organ, tumor, or tumor bed. Additional information may be obtained from the relative distance, relative orientation and change of shape or position of the two or more markers. [0021] According to another aspect of the invention, a method is provided for determining the change of shape, size or location of an excision cavity. Having performed an excision, the surgeon positions one or more markers of the invention along a periphery of the excision cavity. The flexibility of the markers of the invention is such that the markers can readily be adapted along the periphery of the excision. The markers can be sutured in place or anchored by means of their tissue anchors. By taking successive images, one can infer the change of shape, size or location of the excision cavity from the change of shape or position of the markers. [0022] According to another aspect of the invention, a method is provided for marking boundaries of anatomical regions in a mammalian body. One obtains a real-time image pursuant to an imaging modality, e.g. ultrasonoscopy, or fluoroscopy, showing the anatomical regions on a display, on which the boundaries of said anatomical regions can be identified. One inserts one or more markers of the invention, guided by the real. time-display, positioning distal and/or proximal ends of the markers at boundaries of the anatomical regions of interest. In a preferred embodiment of said method, the anatomical region of interest is the prostate region, and the boundaries include the prostate apex, the prostate base, the prostate-rectum boundary, the lateral boundaries of the prostate, and the boundaries of the colon, the urethra, the bladder, the seminal vesicles, the neurovascular bundles and the penile bulb. The real-time image may advantageously be obtained through a transrectal ultrasound probe. [0023] According a further aspect of the invention, a method is provided for fashioning a plurality of images obtained trough one or more imaging modalities (e.g. X-ray radiography, CT-scan, Ultrasonography), of an anatomical region. One inserts one or more markers of the invention in or near the anatomical region of interest. One obtains images of the anatomical region, showing i.a. the markers of the invention. The images are then processed for modifying the scales and orientations so as to align the sizes, shapes and positions of the markers in each of the images. [0024] In a variation of the method for fusioning images, one inserts two or more markers in or near the anatomical region. One can then use the relative distances and relative orientations of the two or more markers for modifying the scales and orientations of the images. SHORT DESCRIPTION OF THE DRAWINGS [0025] FIGS. 1 a to 1 d show how a pair of markers according to the invention can be used to follow the change of shape of an organ. [0026] FIGS. 2 a and 2 b show a pair of parallel markers according to the invention can be used to follow the change of shape of an organ. [0027] FIG. 3 a represents an organ after insertion of an interstitial marker. FIG. 3 b represents same organ and markers after increase in size of part of organ, and FIG. 3 c represents same organ and markers after decrease in size of organ. [0028] FIG. 4 shows a marker inserted as used for marking a biopsy site. [0029] FIG. 5 is a schematic representation of a set of markers inserted into a prostate. [0030] FIG. 6 is a perspective view of an apparatus used for positioning a set s of markers into a prostate. [0031] FIG. 7 is a side view of a marker according to invention, where the marker is a helical coil, having a constant pitch. [0032] FIG. 8 is a side view of a marker according to the invention, where the marker is a helical coil, having sections of high pitch and sections of low pitch. [0033] FIG. 9 a - 9 d are images of the marker according to the invention, obtained from various imaging techniques. DETAILED DESCRIPTION OF THE INVENTION [0034] The coiled marker of the invention is of such flexibility, both axially and transversally, so that, when inserted in a flexible organ such as a breast or a prostate, it will follow the changes of shape of said organ. The lateral flexibility of the markers must be similar to the flexibility of the tissues in which they are inserted. The coiled marker does not present any mechanical. resistance to the change of shape. After insertion through a needle, the marker is largely straight. When the organ changes in shape, either under the influence of the treatment, or under natural growth or stresses, the flexible markers will take a curved shape. It has been experienced that the coiled markers grip the organ they arc inserted into, and follow the longitudinal change of shape. One can therefore follow the change of shape and relative position of markers for following increase in size and change of shape of the organ. The fact that the markers of the invention have an excellent ultrasound visibility means that these repeated examination may be performed with the ultrasound technique, thereby avoiding the doses of repeated X-ray exposures. [0035] The implantation of two or more coiled markers in an organ allows following the position of the organ in the body. This is especially necessary for flexible organs such as breast or prostate. Depending on contents of bladder or colon, the prostate may be displaced by several cm. Treatment by an external beam may be directed with a precision better than 1 mm. [0036] FIGS. 1 a, 1 b, 1 c 1 d illustrate how the change of shape of an organ can be followed using the markers of the invention. In FIG. 1 a , two markers 1 , 2 have been inserted into an organ 3 (symbolized here as a gel-filled balloon). The markers are straight after insertion. In FIG. 1 b , the organ has been submitted to a uniform pressure from above, and the change in shape of the organ can be inferred from the change in relative orientation of the markers. Similarly, in FIG. 1 c , the organ has been submitted to a uniform tension from above, and the markers show a corresponding change in relative position. In FIG. 1 d , the organ has been submitted to a non uniform pressure, e.g. due to stresses within the body (full bladder or stomach, gas, swelling, etc), stresses from localized growths (tumors), external stresses (clothing or hardware in contact with the patient), changes in weight, changes in hydration, etc. These are reflected in the change of shape of the intervening length of marker 1 . [0037] The use of two or more interstitial markers of the invention inserted parallel allow even better follow-up of the change of shape, as shown on FIGS. 2 a and 2 b. [0038] As illustrated on FIGS. 3 a , 3 b , and 3 c , the evolution of an organ or tumor can be followed using the interstitial markers of the invention. In FIG. 3 a , one or more markers have been inserted parallel and straight around a region of interest 4 . Subsequent images are taken after a period and can show growth ( FIG. 3 b ) or decrease in size ( FIG. 3 c ) of the region of interest. It is to be emphasized that the imaging technique used for the follow-up must be able to see the markers, but do not have to be able to see the region of interest. Therefore, an imaging technique that is faster, less invasive, or more comfortable for the patient can be used. Especially, the ultrasound imaging technique can be used. [0039] Another application of the interstitial marker according to the invention is the marking of an “excision bed”. Specifically, in numerous medical procedures a volume of tissue is surgically removed, such as in the case of a lumpectomy. In many of these cases it is important to be able to return to this same tissue volume for follow-up procedures such as radiation therapy, additional surgical excision, etc. As this “empty” volume is ill defined until the healing process is complete, elongated flexible markers placed in the tissue immediately adjacent to this volume can provide a detailed description of the location. In this case, point markers suffer the same deficiencies as identified above for soft tissue or tumor volume marking with the added issue that the typical 2-3 mm migration can cause the marker to fall into the excision volume and simply be “floating” in this tissue void. The extended length of the interstitial marker according to the invention eliminates this possibility. In these cases, the elongated marker could be either inserted into the target tissue or sutured in place in cases where an open surgical procedure has been used. FIG. 4 represents a human breast 5 indicating the subsurface excision bed 6 (void formed by the lumpectomy), and the skin-level surgical scar 8 . The surgeon would have the option of deploying a continuous length of marker 7 around the periphery of the excision bed or several lengths placed strategically about the bed itself. [0040] The marker according to the invention is particularly useful in the external beam therapy of prostate cancer. Patients who have been diagnosed with prostate (or other) cancer have a number of surgical (radical prostatectomy or other surgical excision of the affected tissue) and non-surgical options to evaluate for their treatment. These non-surgical options include radiation therapy options, hormone therapy, hypothermia, hyperthermia, drugs and genetic therapy. To date, only radiation therapy and surgical removal have shown 10-year disease free survival rates above 80% and represent the standard of care in the industry. Of the radiation therapy options, the optimal goal is to deliver as much radiation (up to the prescribed dose) as possible to the organ (in this case prostate) and as little radiation as possible to all the surrounding tissues to reduce the comorbidity (or side effects) of this procedure. As a result, the progression of external beam radiation therapy over the past two decades has been focused on providing a beam of radiation that matches the shape of the organ. With each passing year, publications show advances in being able to target the radiation in more effective was and continually lessening the dose to adjacent tissues. At this point in time, the most accurate of these therapies (proton therapy) claim the ability to localize the beam to 0.1 mm of the intended target location. [0041] FIG. 5 illustrates the method for marking the boundaries of anatomical regions, with the application to the prostate 9 . Elongated marker 10 has been inserted in the prostate, near the prostate/rectum boundary. Such marker may typically have a length of 4 cm, and is used for height adjustment. Elongated markers 11 and 12 are located at the left and right hand side of the prostate, and delimit the lateral width of the gland in the mid-plane. These markers are used in conjunction with marker 10 for left-right alignment. Marker 13 defines the prostate apex, and is used for cranial-caudal adjustment of patient position. Marker 14 defines the prostate base, and is used also for cranial-caudal adjustment. Once in place, these markers will follow the change of position, size and orientation of the gland, and thereby allow follow-up of the decrease or increase in size of the organ, and allow precise positioning and directing during radiation beam treatment. [0042] FIG. 6 illustrates a known device 15 used to deploy the elongated marker pattern identified in FIG. 5 through the use of needles 16 and a rectilinear template 17 designed for transperineal alignment with TRUS (transrectal ultrasound), and a method of patterned insertion of the elongated markers 1 through these needles, with pusher wires. Prostate markers may also be inserted digitally through the rectum and positioned with tactile guidance and/or ultrasound imaging guidance. [0043] FIG. 7 represents a coiled marker 1 , having an outer diameter of 500 μm (0.5 mm), made of thin wire having a rectangular section of 50×200 μm, coiled with the broad side along the axis of the coil, and having a length of 5 cm. The length of the marker may be chosen as required by the application, and may be as short as 1 cm for marking the longitidinal ends of an organ, as in the case of prostate apex and base, and as long as necessary, e.g. for biopsy sites, where lengths of 10 cm or more may be used. Depending on the application, the outer diameter may be chosen between 25 μm and 2500 μm, and the wire may have a circular cross section with a diameter between 10 μm and 2500 μm or a rectangular cross section with sizes between 10 μm and 500 μm. The aspect ratio i.e. the ratio of length to outer diameter in the example shown is 100, but it has been determined that an aspect ratio in the range on 10 to 250 or higher provides a good combination of flexibility and x-ray and ultrasound visibility. Another characteristic feature of a helical coil is the pitch, that may be defined as the axial length between two successive coil windings. [0044] Other examples of coils suitable for particular applications are given below: EXAMPLE 1 [0045] Primarily designed for use with ultrasound or diagnostic x-ray imaging techniques. [0000] Material Rhodium Helix Outer Diameter 350 μm Helix Inner Diameter 250 μm Rectangular wire, size 200 × 50 μm Wire Pitch 240 +/− 40 μm EXAMPLE 2 [0046] Designed primarily for diagnostic x-ray, fluoroscope or ultrasound [0000] Material Platinum Helix Outer Diameter 500 μm Helix Inner Diameter 350 μm Circular wire 75 μm diameter Wire Pitch 90 +/− 9 μm EXAMPLE 3 [0047] Primarily designed for Portal Imaging (high energy x-rays) [0000] Material Gold Helix Outer Diameter 2.0 mm Helix Inner Diameter 1.2 mm Wire Diameter 0.4 mm Wire Pitch 0.48 +/− 0.08 mm [0048] The lateral flexibility obtained by using a coil according to the invention is very high. This flexibility is easily determined by measuring the droop of a length of helical coil fastened horizontally from one end. The other end droops in response to its own weight. It was determined that a coil made of stainless steel, having an outer diameter of 350 μm, a rectangular cross section wire of 200 μm by 50 μm, a 220 μm pitch, and a free length of 35.5 mm, droops by 2.9 mm. [0049] FIG. 8 represents a preferred embodiment of a coiled marker 1 , having sections of different pitch. Sections of high pitch 18 (less dense coils) provide a good flexibility, while sections of low pitch 19 (dense coils) provide good x-ray and ultrasound visibility. [0050] FIG. 9 a - 9 d represent images of the marker coils of the present invention obtained from various imaging techniques: fluoroscopy ( FIG. 9 a ), CT ( FIG. 9 b ), x-ray ( FIG. 9 c ) and ultrasound ( FIG. 9 d ). [0051] It has been discovered by the inventors of the present invention that a helical coil, such as disclosed in U.S. Pat. No. 6,419,621, which is incorporated herein by reference, can effectively be used as an interstitial marker according to the invention. More precisely, said document discloses a radioactive coiled wire. These radioactive coiled wires are obtained through an activation process that may be exposure to an accelerated beam of charged particles of a precursor material, through ion implantation technique, or through thin film deposition of an isotope. The coil that can be used as interstitial marker is the coil prior to activation. This allows using same material for use as an interstitial marker as well as precursor for making a brachytherapy device. These coils may also be used after activation, and be used simultaneously as a brachytherapy device and as a marker, for a combined brachytherapy/external beam irradiation treatment.

1a

REFERENCE TO PENDING PRIOR PATENT APPLICATION This patent application claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 60/849,297, filed Oct. 4, 2006 by William E. Cohn et al. for PORTABLE REVERSE ISOLATION BOX (PRIB), which application is hereby incorporated herein by reference. FIELD OF THE INVENTION This invention relates to enclosures in general, and more particularly to an enclosure for protecting the contents of the enclosure from the environment and/or for protecting the user from the contents of the enclosure, particularly when performing recreational and household tasks. BACKGROUND OF THE INVENTION In many cases it is desirable to protect an object from the environment, and/or to protect the user from an object, particularly when performing recreational and household tasks. By way of example but not limitation, it can be desirable to protect a book from bath water, or to protect a cook from onion fumes. SUMMARY OF THE INVENTION This invention is a portable reverse isolation box (PRIB) for home use to facilitate common recreational and household tasks where a reverse isolation system will be beneficial to protect the contents of the PRIB from the environment, and/or to protect the user (and/or bystanders and/or the environment) from the contents of the PRIB. In one preferred form of the present invention, there is provided a portable reverse isolation box (PRIB) for protecting an object from the environment and/or protecting a user from the object, the PRIB comprising: a housing comprising a container and a lid, wherein the container has structural integrity and at least a portion of the lid is transparent, and further wherein the housing forms an airtight and watertight isolation bay when the lid is mounted on the container; a port formed in the container; and a disposable flexible element mounted in the port in an airtight and watertight relationship, the flexible element being capable of assuming a concave configuration so as to permit a user to manipulate the object within the isolation bay without opening the lid. In another form of the present invention, there is provided a method for utilizing a portable reverse isolation box (PRIB), the method comprising: providing a portable reverse isolation box (PRIB) for protecting an object from the environment and/or protecting a user from the object, the PRIB comprising: a housing comprising a container and a lid, wherein the container has structural integrity and at least a portion of the lid is transparent, and further wherein the housing forms an airtight and watertight isolation bay when the lid is mounted on the container; a port formed in the container; and a disposable flexible element adapted to be mounted in the port in an airtight and watertight relationship, the flexible element being capable of assuming a concave configuration so as to permit a user to manipulate the object within the isolation bay without opening the lid; placing the object in the container; mounting the lid on the container; compressing the housing so as to reduce the volume of the isolation bay, and maintaining the housing in the compressed condition; mounting the disposable flexible element in the port in an airtight and watertight relationship; and releasing the housing so that the disposable flexible element is drawn into the interior of the isolation bay in a concave configuration. In an additional form of the present invention, there is provided a method for utilizing a portable reverse isolation box (PRIB), the method comprising: providing a portable reverse isolation box (PRIB) for protecting an object from the environment and/or protecting a user from the object, the PRIB comprising: a housing comprising a container and a lid, wherein the container has structural integrity and at least a portion of the lid is transparent, and further wherein the housing forms an airtight and watertight isolation bay when the lid is mounted on the container; a port formed in the container; and a disposable flexible element adapted to be mounted in the port in an airtight and watertight relationship, the flexible element being capable of assuming a concave configuration so as to permit a user to manipulate the object within the isolation bay without opening the lid; removing the disposable flexible element from the port; and mounting a fresh disposable flexible element in the port. BRIEF DESCRIPTION OF THE DRAWINGS These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein: FIG. 1 is a schematic view showing a novel portable reverse isolation box (PRIB) formed in accordance with the present invention, wherein the PRIB has its lid closed; FIG. 2 is another schematic view showing the novel portable reverse isolation box (PRIB) formed in accordance with the present invention, wherein the PRIB has its lid closed; FIG. 3 is another schematic view showing the novel portable reverse isolation box (PRIB) formed in accordance with the present invention, wherein the PRIB has its lid closed; FIG. 4 is another schematic view showing the novel portable reverse isolation box (PRIB) formed in accordance with the present invention, wherein the PRIB has its lid closed; FIG. 5 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 , except with the lid opened; FIG. 6 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 , except with the lid opened; FIG. 7 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 , except with the lid opened; FIG. 8 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 , except with the lid opened; FIG. 9 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 , except with the lid removed; FIG. 10 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 , except with the lid removed; FIG. 11 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 , except with the lid removed; FIG. 12 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 , except with the lid removed; FIG. 13 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 14 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 15 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 16 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 17 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 18 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 19 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 20 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 21 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 22 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 23 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 24 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 25 is a schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 26 is another schematic view showing details of the main housing, ports, and disposable gloves of the PRIB shown in FIGS. 1 , 2 , 3 and 4 ; FIG. 27 is a schematic view showing reading material being placed in the PRIB of FIGS. 1 , 2 , 3 and 4 ; FIG. 28 is a schematic view showing reading material being placed in the PRIB of FIGS. 1 , 2 , 3 and 4 ; FIG. 29 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 floating in water; and FIG. 30 is a schematic view showing the PRIB of FIGS. 1 , 2 , 3 and 4 floating in water. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Looking now at the drawings, there is shown a portable reverse isolation box (PRIB) 5 formed in accordance with the present invention. PRIB 5 comprises a main housing 10 . More particularly, main housing 10 comprises an airtight/watertight container 15 with a transparent lid 20 which allows the contents of the PRIB to be easily seen and manipulated. Lid 20 is provided with a closure 25 for selectively closing off the interior of container 15 . Container 15 is of a size which is adequate to accommodate the item which the user is trying to protect, and/or from which the user is trying to be isolated from. The interior of container 15 is the isolation bay 30 . For example, a PRIB designed to facilitate reading a paperback book in a tub or a bath, in or by the pool, or at the beach, without incurring cumulative water damage to the book, has an isolation bay 30 which is large enough to hold the desired book with the book open and to provide sufficient room to turn the pages easily. Furthermore, isolation bay 30 of PRIB 5 is of an appropriate geometry so as to allow an item to be manipulated in the desired fashion. In a preferred construction, isolation bay 30 is also of an appropriate geometry to limit the ability of an item to shift or be moved in an undesirable fashion. For example, a PRIB 5 designed for a paperback book preferably has an isolation bay 30 of limited depth as a means of keeping the pages from flipping spontaneously, and as a means of keeping the book from spontaneously closing or flipping over when PRIB 5 is transported. It is important to note that, although main housing 10 of PRIB 5 is shown with a “box-like” geometry, any appropriate geometry may be used, with aspects of main housing 10 composed of rigid, semi-rigid, or flexible material to optimize a specific PRIB 5 for its intended use. Integrated into one or more locations on main housing 10 of PRIB 5 are ports 35 ( FIG. 18 ) into which disposable rubber gloves 40 or other disposable elements are attached in airtight/watertight continuity with isolation bay 30 . Ports 35 are designed with features that allow gloves 40 or other disposable members 40 to be rapidly and easily changed, e.g., such as when a glove becomes torn or damaged. By way of example but not limitation, ports 35 may comprise a rim 45 ( FIG. 18 ) having threads 60 thereon. Gloves 40 are inserted into ports 35 and their cuffs are stretched over rims 45 . Then ring caps 50 are screwed over the cuffs of the gloves, whereby to secure gloves 40 inside ports 35 . On account of this construction, the user may pass their hand ( FIG. 4 ) into the interior of PRIB 5 so as to manipulate objects within PRIB 5 while maintaining isolation therefrom. Thus it will be seen that PRIB 5 is designed so that the airtight/watertight nature of the connection to isolation bay 30 is maintained after changing disposable rubber gloves 40 or other disposable elements 40 . In some iterations of PRIB 5 , one or two ports 35 with disposable gloves 40 attached allow an individual to insert one or two hands into the isolation bay of main housing 10 and manipulate an isolated item while visualizing the item through the PRIB's transparent lid 20 . In other iterations of the PRIB, disposable elements 40 are designed to allow insertion of part or all of one or more fingers, or the distal half of one or both hands, but are not true “gloves” in the full sense of the word. In still other iterations, disposable elements 40 comprise one or more extended gloves that allow the hand, wrist, forearm, and elbow to be inserted into the isolation bay. And in still other iterations, multiple sets of disposable elements 40 allow two or more individuals to insert fingers, hands, and/or arms into a common isolation bay to allow for coordinated efforts between two or more individuals as may be required in some games or other endeavors. In other iterations, disposable elements 40 are designed to accommodate tools, implements, feet, or other appendages that could be used to manipulate items in the isolation bay 30 of PRIB 5 . Different versions of PRIB 5 are designed for dedicated purposes to maximize function for a given task while optimizing size and geometry. Examples of uses for which such dedicated PRIBs are designed include, but are not limited to the following constructions. PRIB for Holding Books, Magazines and/or other Paper Products Several varieties of PRIB 5 may be configured to hold books, magazines, and/or other paper products. In one embodiment, PRIB 5 is configured to isolate a paperback or similar size book so as to allow the book to be read in a tub or sauna, at the beach, in or by the pool, in the rain or other hostile environments, while protecting the book from cumulative water and/or other damage. Disposable elements 40 allow the pages to be turned effortlessly, and transparent lid 20 allows the book to be read through the PRIB. An ultra-bright white LED or other light (not shown) may also be incorporated into the PRIB so as to facilitate visualization. The PRIB geometry and sizing keeps the book open to the desired page (i.e., by prohibiting the book from closing without opening the lid), thereby providing additional functionality. The PRIB may be designed to be propped up on one's knees in the tub. Alternatively, the PRIB could have a floating base and/or a beveled isolation bay which holds the book at the optimal angle for reading in the water or other environment. In another embodiment, PRIB 5 is configured to isolate a larger book for reading in the tub or sauna, at the beach, by the pool, in the rain, or other hostile environments, while protecting the book from cumulative water and/or other damage. Disposable elements 40 allow the pages to be turned effortlessly, and transparent lid 20 allows the book to be read through the PRIB. An ultra-bright white LED or other light (not shown) may also be incorporated into the PRIB so as to facilitate visualization. The PRIB geometry and sizing keeps the book open to the desired page (i.e., by prohibiting the book from closing without opening the lid), thereby providing additional functionality. The PRIB may be designed to be propped up on one's knees in the tub. Alternatively, the PRIB could have a floating base and/or a beveled isolation bay which holds the book at the optimal angle for reading in the water or other environment. In another embodiment, PRIB 5 is configured to isolate a book of antiquarian or historical value from cumulative stress and deterioration while being handled by users, and provide a non-stress, non-hostile environment for the book. The book is protected by the PRIB from atmospheric moisture, skin oil, and unanticipated spills, sneezes and/or other misadventures. In another embodiment, PRIB 5 is configured to hold a crossword puzzle or other work or game book, along with a pen, pencil, marker or other writing instrument, so as to allow the crossword puzzle or other work or game book to be used as intended in the tub, in the sauna, at the beach, by the pool, in the rain, or other hostile environments, while protecting the crossword puzzle or other work or game book from cumulative water and/or other damage. In another embodiment, PRIB 5 is configured to isolate a coloring book or other game or workbook, along with multiple colored markers, pens, paints or crayons, thus allowing the coloring book to be used as intended while protecting the environment from stains and marking by the pens. This is of value with small children and/or others for whom careful control of permanent markers and/or other potentially destructive writing and/or drawing implements is challenging. By virtue of the airtight and watertight construction of the PRIB, the markers or pens would never be lost and would dry out much more slowly if left uncapped than they otherwise would if left in the open air. The caps for the markers or pens may be permanently affixed to the inner aspect of the isolation bay in order to keep the markers or pens organized between uses or during use. The isolation bay may also have childproof features that prevent a child from opening the isolation bay without adult help. Several coloring books or workbooks may be placed in the isolation bay at once, and the child could rearrange them to get to the desired book, open to the desired page, and color with markers, all within the PRIB isolation bay, without risk of marking or staining the environment. A PRIB of this type is valuable and entertaining for children during long drives in the car, where losing caps and markers and avoiding destructive marker mishaps is challenging. Another potential use is in a pediatrician's waiting room, where a fresh pair of disposable gloves allows a toddler or child to color without risk of transmission of infectious agents, avoids marker stains, avoids lost markers and caps, helps prevent markers from drying out, etc. In an alternative embodiment, PRIB 5 may be positioned on an easel (not shown) and could house a large tablet of paper held vertically and finger-paints. The paints would not dry out, and the child's clothes and the environment are isolated and protected from artistic misadventure. PRIB for Use in the Kitchen Other varieties of PRIB could be designed for food preparation in the kitchen so as to facilitate clean up after messy tasks and/or to isolate the user from noxious stimuli. In one embodiment of the present invention, PRIB 5 is designed for cutting or dicing onions. In this embodiment, base 55 ( FIG. 5 ) of isolation bay 30 may be made of materials, and configured like, a cutting board and a knife or other cutlery may be placed in the box alongside one or more onions, cloves of garlic, or other noxious food. The airtight and watertight lid of the PRIB may then be secured, with the onions and knife in the isolation bay. The onions are then peeled, sliced, and diced inside the enclosure of the PRIB. The PRIB contains the noxious fumes and helps keep the diced onions fresh until such time as they are needed. In another embodiment of the present invention, PRIB 5 is configured to prepare freshly caught fish, oysters, clams, squid, shrimp, crabs and the like, or for skinning and/or cleaning small game. With the PRIB, the scales, shells, bones, viscera and such could be readily contained and disposed of with effectively no mess to clean up. In another embodiment of the present invention, PRIB 5 may be designed for marinating or breading food. By way of example, it is sometimes desirable to roll meat, poultry, or fish in flour, breadcrumbs, cornmeal, or other granular foodstuff. Similarly, it is sometimes desirable to coat food in marinades or other sauces for prolonged periods of time. A PRIB of this variety would allow the user to place the meat, poultry, or fish in the isolation bay, along with the breading or sauce and a brush or other appliance to facilitate the even dispersal of the coating. The food may remain in the isolation bay with the marinade for prolonged periods of time, as is done with conventional marinade processes. With a PRIB of this variety, one is able to reposition the food that is being marinated or breaded, facilitating even dispersal, without touching either the food or sauce. Accordingly this PRIB minimizes mess, facilitates clean-up, and allows the procedure to be performed, in some cases even without taking the PRIB out of the refrigerator. PRIB for Use in a Home Shop In another embodiment of the present invention, a PRIB may be optimized to facilitate projects in the home shop, including cleaning parts or removing glue or paint with noxious solvents or thinners, painting or coating objects in a dust-free environment, or assembling multiple small components without risk of dropping and/or loosing them. PRIB with Multiple Ports Other PRIBs are designed with multiple ports 35 so as to allow multiple individuals to play cards or other games in the tub, in the sauna, at the beach, by the pool, in the rain or other hostile environments. One iteration allows a plurality of players to each insert two hands into a large floating circular PRIB so as to allow “pool poker” to be played. The isolation bay is loaded with chips and cards and then the lid is sealed. The entire game is played within the watertight and airtight isolation bay. A PRIB of this type also shelters cards from the wind so as to facilitate poker at the beach and/or other challenging environments. Some of the unique and patentable features of the novel PRIBs include their low cost, ease of use, portability, and dedicated design for a specific task. Features that maximize these aspects of function include a low-cost, injection-molded construction, small size and the incorporation of inexpensive, easily replaced, disposable gloves. Unlike most currently available isolation hoods or tents, which are intended for use with radioactive materials, biohazards, infectious material, carcinogens, poisons, or caustic substances, etc, the ramifications of device failure with the PRIBs are substantially less. As such, the gloves can be inexpensive, disposable gloves 40 that are readily available, and which can be easily replaced as needed. Alternatively, some types of PRIBs may require dedicated disposable members 40 , e.g., either full arm-length gloves, partial hand gloves, or other geometries. These disposable elements 40 could be very cheaply fabricated due to the intended use and limited consequences of breach or leak. The PRIB of the present invention provides a fast, simple and reliable approach for replaceably attaching the gloves to the PRIB, e.g., a threaded neck for receiving the wrist of the glove, and a threaded rim for capturing the wrist of the glove to the threaded neck. Furthermore, because the isolation bay is watertight/airtight, it could be manipulated during closure of the lid to force an egress of air, such that after the forced egress of air is completed, the sealed isolation bay of the PRIB is at a sub-atmospheric pressure. Thus, the PRIB can be “burped” like a Tupperware container. The “burping” causes the disposable gloves or other disposable elements to inflate with room air or water (whatever was outside the box), which facilitates insertion and removal of one's hands while accessing the contents of the PRIB. By way of example but not limitation, the PRIB can be formed out of a flexible plastic such that the PRIB can have its isolation chamber reduced in size (e.g., by pressing one or more walls inwardly), closing the lid, and then allowing the isolation chamber to return to its normal size (e.g., by releasing the inward pressure on the one or more walls). The arrangement will effectively cause the isolation chamber to have an interior air pressure which is lower that the exterior air pressure, so that the gloves will be automatically inflated. Modifications It will be understood that many changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the invention, may be made by those skilled in the art without departing from the principles and scope of the present invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of the filing date of U.S. Provisional Patent Application No. 61/621,291, filed Apr. 6, 2012, the disclosure of which is hereby incorporated herein by reference. BACKGROUND OF THE INVENTION Certain lung diseases, such as emphysema, reduce the ability of a person's lungs to sufficiently oxygenate blood. If parts of a patient's lungs are removed due to conditions such as lung cancer, the ability to oxygenate blood is impaired. Persons having such conditions require assistance in providing oxygenated blood to their bodies. Some patients with such conditions can survive if oxygen-enriched air is supplied to their lungs, as by use of an oxygen mask. However, other patients do not have sufficient lung capacity for survival with these measures. It has been proposed to provide blood oxygenators to such patients. A blood oxygenator is a device which exposes the patient's blood to air or oxygen as the blood flows through the device. Blood oxygenators have long been used as a component of the so-called “heart-lung machine” to provide short-term support to a patient during surgical procedures such as heart surgery or transplantation. However, the systems incorporating such oxygenators require frequent and professional maintenance, and are suitable for use only in a hospital setting. These systems typically require that the patient be confined to a bed, which drastically impairs the patient's quality of life. Thus, there has been a significant need in the art for a patient support system using an oxygenator which can be used for long-term treatment, desirably outside of a hospital environment. BRIEF SUMMARY OF THE INVENTION One aspect of the disclosure provides a system for oxygenating blood. The system may include a blood pump having an outlet and an inlet adapted for communication with the circulatory system of a mammalian subject at an inlet location. The system may further include one or more return fittings adapted for communication with the circulatory system of the subject at one or more return locations remote from the inlet location. The system may further include a blood oxygenator having a blood inlet releasably connectable in communication with the outlet of the pump and a blood outlet releasably connectable in communication with one of said return fittings. The system may further include a bypass conduit adapted to connect the outlet of the pump in communication with one of said return fittings at least when the oxygenator is disconnected. In one variation, the system further includes an oxygenator inlet disconnect fitting connected to the outlet of the blood pump and an oxygenator outlet disconnect fitting connected to one of said return fittings, the blood inlet and outlet of the oxygenator being adapted to releasably engage the disconnect fittings. In another variation, the system further includes an adapter having an inlet connected to the outlet of the blood pump, a first branch connected to the oxygenator inlet disconnect fitting and a second branch connected the bypass conduit. In another variation, the system further includes a valve in the adapter having a normal condition in which blood flow entering the adaptor is directed primarily to the first branch and a bypass condition in which blood flow is directed primarily to the second branch. In another variation, the system further includes a valve connected in series with the bypass conduit, the valve having a normal condition in which flow through the bypass conduit is at least partially blocked and a bypass condition in which flow through the bypass conduit is substantially unblocked. In another variation, when the valve is in the normal condition, flow through the bypass conduit is only partially blocked. In another variation, the pump is an implantable pump configured to be implanted within a mammalian subject body. In another variation, the implantable pump is biocompatible. In another variation, the pump is selected from a group consisting of: an axial-flow blood pump, and centrifugal blood pump. In another variation, at least one of the one or more return locations is selected from a group consisting of: a right atrium, a right ventricle, or a pulmonary artery. In another variation, the inlet location is a pulmonary artery. In another variation, the bypass conduit is configured to be at least partially disposed within the mammalian subject body. In another variation, an internal diameter of the first branch is different than an internal diameter of the second branch. In another variation, the internal diameter of the first branch is larger than the internal diameter of the second branch. Another aspect of the disclosure provides a method of providing respiratory assistance to a mammalian subject. The method includes (a) directing blood from an inlet location in the circulatory system of the subject through a pump, through an oxygenator and back to the circulatory system. The method may further include (b) temporarily disconnecting the oxygenator. The method may further include (c) directing blood through the pump and through a bypass conduit back to the circulatory system. The method may further include (d) reconnecting the same oxygenator or a different oxygenator and then resuming step (a). In one variation, steps (b), (c) and (d) are performed so that blood continuously flows through the pump. In another variation, in step (c), the blood is directed back to the pulmonary artery of the subject. In another variation, in step (a), the blood is directed back to the pulmonary artery of the subject. In another variation, the method further includes the step of directing blood through the bypass conduit and back to the circulatory system during step (a). In another variation, during step (a), blood passes through the oxygenator at a first rate and blood passes through the bypass conduit at a second rate less than the first rate. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a diagrammatic view of a system according to one embodiment of the invention in conjunction with the circulatory system of a patient. FIGS. 2 and 3 are views similar to FIG. 1 but depicting systems according to further embodiments of the invention. DETAILED DESCRIPTION A system 200 according to one embodiment of the invention includes a blood pump 204 having a pump inlet 204 b and a pump outlet 204 a . The blood pump 204 desirably is a pump suitable for providing pumping action over a long period of time, such as months or years, without severe hemolysis or other severe effects on the blood. Pumps of the type used to provide long-term assistance to the heart, sometimes referred to as “ventricular assist devices” or “VADs” can be used. The pump desirably is a load-sensitive pump having a flow versus pressure characteristic such that the flow through the pump decreases progressively with the pressure head opposing the flow. Stated another way, the pump desirably is not a positive-displacement pump. Impeller pumps such as centrifugal or axial-flow impeller pumps can be used. The pump desirably is arranged so that it can be carried by the patient and powered by a portable power supply. Most desirably, the pump is implantable within the body of the patient. Implantable blood pumps are described in U.S. Pat. Nos. 7,699,586, 7,972,122, and 8,007,254, the disclosures of which are incorporated by reference herein. For example, an axial-flow impeller pump of the type supplied by HeartWare, Inc. of Miami Lakes, Fla. under the trademark MVAD can be used. A pump inlet conduit 202 is connected to pump inlet 204 b . The pump and the inlet conduit are arranged so that the pump inlet 204 b can be connected to an inlet location 122 within the circulatory system of the subject. The system further includes a pump outlet conduit 206 having one end connected to the outlet 204 a of the pump and having the other end connected to a branching adaptor 208 . Adaptor 208 has a single inlet connected to pump outlet conduit 206 and has two outlets. A first outlet of adaptor 208 is connected to an oxygenator supply conduit 210 , also referred to as a first branch. The second outlet of adaptor 208 is connected to a bypass conduit 228 , also referred to as a second branch. Adaptor 208 includes a valve 208 a that can be actuated between a first position in which the flow of blood entering the adaptor is directed primarily to first branch 210 , and a second position in which the flow is directed primarily or entirely to or second branch 226 . Oxygenator supply conduit 210 extends to an oxygenator inlet disconnect fitting 212 . Disconnect fitting 212 includes an interface arranged to releasably connect conduit 210 in communication with a mating fitting 212 a and form a fluid-tight seal with the mating fitting when connected. The disconnect fitting may also include an internal valve (not shown) arranged to block flow through the disconnect and conduit 210 when the mating fitting is disconnected. The system further includes an oxygenator outlet disconnect fitting 220 similar to fitting 212 . Outlet disconnect fitting 220 is connected to one end of an oxygenator return conduit 222 . Fitting 220 is adapted to releasably engage a mating fitting 220 a in a fluid-tight seal so as establish communication between fitting 220 a and conduit 222 . Disconnect fitting 220 may also include a valve (not shown) for closing the end of conduit 222 when fitting 220 a is disconnected. Merely by way of example, suitable disconnect fittings are commercially available from NovaLung GmbH of Baden-Württemburg, Germany. An oxygenator 216 has a blood inlet 214 with a fitting 212 a mateable with oxygenator inlet disconnect fitting 212 , and has a blood outlet 218 with a fitting 220 a mateable with outlet disconnect fitting 220 . Oxygenator 216 is configured to remove carbon dioxide from blood passing through the oxygenator, and to supply oxygen to the blood. For example, the internal construction of oxygenator 216 may be the same as that of a QUADROX® Oxygenator System manufactured by Maquet. The oxygenator 216 may include subcomponents typically associated with an oxygenator, such as a permeable membrane and oxygen supply. The oxygenator desirably is arranged so as to be portable and allow the patient to move about while connected to the oxygenator. For example, the oxygenator may be coupled to a portable oxygen supply such as a cylinder (not shown). Desirably, the oxygenator and supply may be carried on a mobile cart or on a harness worn by the patient. Oxygenator return conduit 222 has a return fitting 224 at the end of the conduit remote from disconnect 220 . The return fitting is adapted for connection to the circulatory system. For example, return fitting 224 may be an end of the conduit adapted for insertion into the vasculature of the patient. Bypass conduit 228 has a similar return fitting 229 at the end of the bypass conduit remote from adaptor 208 . In the condition depicted in FIG. 1 , the system is in place in a mammalian subject such as a human patient in need of respiratory assistance. Pump 204 is implanted within the body of the patient, with inlet conduit 202 connected to the circulatory system 100 of the subject at an inlet location 122 such as the right atrium 120 of the heart or the right ventricle 130 , so that the inlet 204 b of pump 204 is in communication with the circulatory system at the inlet location. Return fittings 224 and 229 and the adjacent portions of conduits 222 and 230 are also implanted in the body of the subject. The return fittings communicate with the circulatory system of the subject at return locations 134 and 136 , respectively. The return locations may be remote from the inlet location. For example, the return locations may be in the pulmonary artery 132 of the subject. Adaptor 206 and disconnect fittings 212 and oxygenator 216 are disposed outside of the subject's body. In a normal condition, oxygenator 216 is connected to disconnect fittings 212 and 220 . With the system in place, the subject's heart 110 continues to pump blood in the normal manner. The right atrium 120 collects oxygen-depleted blood from the systemic circulatory system of the body B. The oxygen-depleted blood flows from the right atrium 120 to the right ventricle 130 . The blood is then pumped into the lungs via the pulmonary artery 132 where the blood is oxygenated and where carbon dioxide is removed from the blood. The oxygenated blood is then returned to the left atrium 140 via the pulmonary veins 142 . The blood is pumped from the left atrium to the left ventricle 150 , and then pumped by the left ventricle and to systemic circulation. After passing through the systemic circulation, the blood becomes oxygen-depleted and returns to the right atrium 120 via the vena cava 125 , where the process begins again. Pump 204 draws some of the blood from the circulatory system 100 of the subject at the inlet location 122 . For example, the flow rate of blood through the pump 204 may be approximately 2 to 5 L/min. In the normal condition, with the oxygenator in place, the blood passing out of pump 204 passes primarily through the first branch, through oxygenator supply conduit 210 , oxygenator 216 and oxygenator return conduit 222 to return fitting 224 , and re-enters the circulation at return location 134 in the pulmonary artery. Oxygenator 216 supplies oxygen to the blood passing along first branch 210 and removes some of the carbon dioxide present in the blood. The oxygenation and carbon dioxide removal provided by the oxygenator supplement the action of the subject's lungs. Valve 208 a of adaptor 208 desirably is arranged to allow a relatively small portion of the blood supplied by pump 204 to pass through the second branch, through bypass conduit 228 and back to the circulatory system at return fitting 229 and return location 136 , while the system is in the normal condition and the valve is in the first position. This flowing blood helps to keep the second branch free of thrombus. The oxygenator must be replaced periodically. To change the oxygenator, the system is brought to a bypass condition by adjusting valve 208 a of the adaptor to the second position. In this condition, the blood passing from pump 204 is directed entirely along the second branch, through the bypass conduit 228 and back to the circulatory system via return fitting 229 at return location 134 . While the system is in this bypass condition, fittings 212 a and 220 a of the oxygenator are disconnected from disconnect fittings 212 and 220 , and a new oxygenator is connected to the disconnect fittings. Once the new oxygenator is in place, the system is returned to the normal condition by readjusting valve 208 a to the first position. Manipulating the valve and actuating the disconnect fittings are routine tasks which do not require a high level of skill. Desirably, these elements are arranged so that the oxygenator can be changed by the patient or by a medical technician or nurse without extensive training. While the system is in the bypass condition, pump 204 continues to operate and blood continues to flow through the pump and through the bypass conduit. The pump thus assists blood circulation through the lungs. This assistance enhances the gas exchange function of the lungs, which helps the subject to survive during the time the system is in the bypass condition. The continued flow of blood through the pump in the bypass condition helps keep the pump free of thrombus. The continued flow of blood through the pump also helps to protect the pump from damage. Certain impeller-type blood pumps use hydrodynamic bearings, magnetic bearings or both to maintain the impeller suspended and out of contact with surrounding parts. While the pump is running, the impeller and surrounding parts do not suffer from mechanical wear, but starting and stopping the pump renders the bearings ineffective and causes wear. The continued flow of blood through the pump in the bypass condition allows the pump to continue running without prolonged exposure of blood in the pump to the relatively severe hydrodynamic conditions in the pump. In a system according to a further embodiment of the invention, the valve in adaptor 208 may be arranged to direct the entire flow of blood through the first branch and thus through the oxygenator 216 in the normal condition. In a further variant, adaptor 208 and valve 208 a may be implanted within the body provided that the valve can be controlled from outside of the body. For example, the valve may be disposed near the skin so that it can be manipulated through the skin. Alternatively, the valve may be provided with an electrically operated or fluid-operated actuation mechanism. A system according to a further embodiment of the invention ( FIG. 2 ) is implanted with the inlet conduit 302 of pump 304 connected to an inlet location within the right ventricle 130 of the subject. This system uses only a single return fitting 329 connected at a single return location in the coronary artery. The system does not incorporate a valve in a branching adaptor as in the embodiment discussed above with respect to FIG. 1 . In the system of FIG. 2 , the bypass conduit 328 remains connected to pump 304 at all times. The bypass conduit incorporates a restriction providing resistance to flow, such as the reduced-diameter section 301 . Desirably, the flow resistance along the second or bypass branch, through the bypass conduit, is greater than the flow resistance along the first branch, through conduit 310 and oxygenator 316 . In the normal condition, most of the blood supplied by pump 304 passes through the first branch, and thus is oxygenated. In the bypass condition, valves 313 and 321 in disconnect fittings 312 and 320 are closed and the oxygenator 316 may be removed and replaced. While the system is in the disconnect condition, some blood continues to pass through the second branch, via bypass conduit 328 . The blood flow through pump 304 and through the second branch is less than the blood flow through the pump during the normal condition, but sufficient to avoid damage to the pump or to the blood disposed within the pump. A system according to yet another embodiment of the invention ( FIG. 3 ) is similar to the systems discussed above, except that the system of FIG. 3 has a second or bypass branch 428 which includes a second oxygenator 401 releasably connected in the second branch by valved disconnect fittings 403 and 405 . As in the systems discussed above, the oxygenator 416 of the first branch is releasably connected by valved disconnect fittings 412 and 420 . The system may be operated in the normal mode with valved fittings 403 and 405 closed, so that blood passes only through the first oxygenator 416 . In the bypass mode, valved fittings 412 and 420 are closed and fittings 403 and 405 are opened, so that the blood passes from the pump 404 through the second branch and second oxygenator. Here again, while the system is in bypass mode, the first oxygenator can be removed and replaced. Because the system provides full oxygenation in the bypass mode, the system can be run in bypass mode for a prolonged period, which may be greater or less than the time the system is run in normal mode. When the system is in normal mode, the second oxygenator 401 can be removed and replaced. In a further variant, the system may run in normal mode with blood passing through both oxygenators, and in bypass mode with blood passing through only one of the oxygenators. The inlet location used to supply blood to the pump may be disposed at any portion of the circulatory system. For example, the inlet location may be disposed at a portion of the circulatory system that transports unoxygenated blood, such as the vena cava or the pulmonary artery. In one example, both the inlet location and the return location may be in the pulmonary artery. A dual-lumen catheter may provide both the inlet and the return fitting. Such a catheter desirably is arranged to prevent recycling of blood from the return location back to the inlet location. In another example, the return locations 134 , 136 may be disposed at the pulmonary vein 142 . According to another embodiment of the disclosure, the oxygenator 216 may be implanted within the body B of the human subject. In this example, the entire system 200 may be implanted within the body B of the mammalian subject. In another embodiment, the valve 208 a at the adaptor ( FIG. 1 ) may be replaced by a valve or valves connected in series with the first branch 210 , in series with second branch 228 , or both. Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

1a

This is a continuation-in-part of copending International Application PCT/IN2007/000367 filed on Aug. 27, 2007, which designated the U.S., claims the benefit thereof and incorporates the same by reference. FIELD OF THE INVENTION The present invention relates to an aqueous formulation useful for selective targeting and delivering of genes to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid. More particularly, the present invention relates to an aqueous formulation useful for enhanced, non-viral, delivery of genetic products to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid, wherein the said cationic lipid, a steroid and a neutral co-lipid are mixed in the ratio in the range of 0.75:0.5:1 to 1:2:1 preferably 0.75:1:1 to 1:2:1. BACKGROUND AND PRIOR ART OF THE INVENTION Chemotherapy and radiation therapies are two current clinical modalities commonly used for the treatment of cancer. Mostly these techniques are effective to block the growth of a tumor; however, there is often a recurrence of the disease, possibly because of incomplete cell killing or cells acquiring drug resistance. Glucocorticoid receptor is a nuclear hormone receptor residing in various cells including both cancerous and non-cancerous cells. It has two subtypes alpha and beta. This receptor, a ligand activated transcription factor, upon activation translocates itself into the nucleus. As a homodimer it binds to specific DNA sequences called glucocorticoid response elements (GRE) and positively or negatively regulates transcription of target genes. Dexamethasone (dex), a potent glucocorticoid acts on intracellular glucocorticoid receptor and regulates transcription of several genes. Several of the glucocorticoids including dex exhibit antiproliferative effect on several tissues of different origin (Corroyer et. al. 1997; Ramalingam et. al. 1997; Rider et. al. 1996; Goya et. al. 1993; Wattenberg and Estensen 1996). These molecules also regulate and control metabolism, development, inflammation, cell growth, proliferation and differentiation (Yamamoto et. al. 1985; Cole et. al. 1995; Rogatsky et al. 1997). In various cancer cells such as in non-small cell lung carcinoma Dex mediates suppression of cellular proliferation through the accumulation of cells in G1/G0 stage of the cell cycle and by hypophosphorylation of retinoblastoma protein (Greenberg et. al. 2002). Glucocorticoid-signaling through glucocorticoid receptors potentiate a possible hypoxia related pathway leading to inflammation. As an anti-inflammatory agent, dex also possesses an important role in inhibiting hypoxia inducible factor (HIF-1), which has direct role in mediating angiogenesis through up-regulation of VEGF (Leonard et. al 2005). Hence, glucocorticoids such as dexamethasone (dex) are a very important and inexpensive drug-like substitute used in various pathological conditions. There is an example of dexamethasone being structurally modified into a cationic entity by conjugating spermine into it. The cationic dexamethsone-spermine compound is used to complex and transfer genes to airway epithelial with concurrent reduction of inflammation (Gruneich et. al. 2004). The viral based gene delivery is quite well known and is extensively investigated utilizing their phenomenally efficient process of delivering genes to wide variety of cells. A number of problems including host toxicity, immunogenic responses and non-specific genomic integration of transferred gene make viral delivery a risky option for delivering genes. In comparison, non-viral gene delivery is a much more robust and clinically safe option compared to viral counterparts. The patented cationic lipid, DODEAC (Banerjee et. al. U.S. Pat. Nos. 6,503,945 and 6,436,516), whose structure is N,N-dihydroxyethyl, N,N-dioctadecyl, ammonium chloride forms cationic liposome using co-lipid cholesterol in membrane filtered water. This product has been used for the transfection of DNA into cultured eukaryotic cells of various origins. However, the formulation in spite of exhibiting moderate transfection of genes to all cells irrespective of origin shows no specific targeting of genes to cancer cells expressing glucocorticoid receptor. Towards this end, the present invention relates to development of a new dexamethasone carrying cationic lipid based formulation, which targets and deliver genes to glucocorticoid receptor expressing cancer cells. Therefore, keeping in view the hitherto known prior art, the inventors of the present invention realized that there exists a need to develop an aqueous formulation useful for selective targeting and delivering gene to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid. The present invention deals with targeted gene delivery which is specific to glucocorticoid receptors of cancer cells only and not of normal cells. The normal cells may be having glucocorticoid receptors but the formulation of the present invention will not target the gene to those normal cells. OBJECTS OF THE INVENTION The main, object of the present invention is to provide an aqueous formulation useful for selective targeting and delivering of genes to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid. More particularly, the object of the present invention is to provide an aqueous formulation useful for enhanced, non-viral delivery of genetic products to cancer cells comprising a cationic lipid, a steroid and a neutral co-lipid, wherein the said cationic lipid, a steroid and a neutral co-lipid are mixed in the ratio in the range of 0.75:0.5:1 to 1:2:1 preferably 0.75:1:1 to 1:2:1. Yet another object of the present invention is to provide a process for the preparation of the said aqueous formulation by formation of small uni-lamellar liposome. Still another object of the present invention is to provide a pharmaceutical composition comprising the said cationic lipid based formulation complexed with a therapeutic amount of biologically active. SUMMARY OF THE INVENTION The present invention provides an aqueous formulation useful for selective targeting and delivering of genes to cancer cells, comprising a cationic lipid, a steroid and a neutral co-lipid. Accordingly, the present invention provides an aqueous formulation useful for enhanced, non-viral delivery of genetic products to cancer cells comprising a cationic lipid, a steroid and a neutral co-lipid, wherein the said cationic lipid, a steroid and a neutral co-lipid are mixed in the ratio in the range of 0.75:0.5:1 to 1:2:1 preferably 0.75:1:1 to 1:2:1. In still another embodiment of the present invention, the said cationic lipid used is selected from the group comprising DODEAC (N,N-dihydroxyethyl, N,N-dioctadecyl ammonium chloride), DOTAP (1,2-dioleoyloxypropyl)-N,N,N-trimethylammonium chloride and DMRIE (1,2-dimyristyloxy-propyl-3-dimethyl-hydroxy ethyl ammonium bromide). In still another embodiment of the present invention, the cationic lipid used is preferably DODEAC (N,N-dihydroxyethyl, N,N-dioctadecyl ammonium chloride) Further in an embodiment of the present invention, the said steroid is selected form the group comprising dexamethasone, predinisolone, fluprednisolone, betamethasone, methylpredinisolone, triamcinolone and hydrocorticosone. In yet another embodiment of the present invention, the steroid used is more preferably dexamethasone. In yet another embodiment of the present invention, the said neutral co-lipid used is preferably cholesterol and is capable of enhancing the transfection efficiency of the said formulation up to 4 fold. In still another embodiment of the present invention, the selective targeting and delivery of gene is achieved by using a non-viral mode. In yet another embodiment of the present invention, the non viral mode includes biologically active molecules selected from the group comprising ribosomal RNA, antisense poly nucleotide RNA, antisense poly nucleotide DNA, genomic polynucleotide DNA, cDNA, and mRNA encoding anti cancer gene. In still another embodiment of the present invention, the gene used for selective targeting and delivery is selected from the group consisting of cytotoxic, anti-cancer and anti-metastatic genes. In yet another embodiment of the present invention, the gene used for selective targeting and delivery is selected from the group comprising p53, tumor necrosis factor Alpha, thymidine kinase, cytosine deaminase, 5 E1A and Tumor growth factor Beta. In still another embodiment of the present invention, the cancer is selected from the group comprising breast, lung, colon and prostate cancer. In yet another embodiment of the present invention, the cancer cell lines used are selected from the group comprising A549 (lung), MCF-7 (breast), HT-29 (colon) and PC-3 (prostate). Further in another embodiment of the present invention, the process for the preparation of an aqueous formulation comprises the following steps of: (a) preparing liposome by dissolving cationic lipid, a steroid and neutral co-lipid in a mole ratio of 0.75:0.5:1 to 1:2:1 preferably 0.75:1.0:1.0-1:2:1 in a mixture of methanol and chloroform in a glass vial; (b) removing, the solvent from the mixture obtained from step (a) using a thin flow of moisture-free nitrogen gas; (c) keeping the lipid film as obtained from step (b) under vacuum for 6-10 hours after drying the film; (d) hydrating the dried lipid film as obtained from step (c) using sterile deionized water to obtain a liposome having total volume of 1 mL for a time period of 10-15 hours; (e) vortexing the liposome as obtained from step (d) for 1-2 minutes to remove adhering lipid film followed by sonicating, in a bath sonicator for 2-3 minutes at room temperature to prepare multi-lamellar vesicles; (f) sonicating the multi-lamellar vesicles with a titanium probe for 1-2 minutes to prepare desired small uni-lamellar vesicles, which is indicated by formation of clear translucent solution; (g) storing the obtained formulation as obtained from step (f) at 0-4° C. until complexed with a biologically active molecule. Further in another embodiment of the present invention, the mole concentration of the steroid and the neutral co-lipid is varied in the range of 0.1-5 mole equivalents separately at a fixed mole concentration of cationic lipid. In still another embodiment of the present invention, freezing and thawing cycles can cause loss of efficiency of the said formulation. In yet another embodiment of the present invention there is provided a pharmaceutical composition comprising effective therapeutic amount of the said formulation complexed with therapeutically acceptable amount of a biologically active molecule. In still another embodiment of the present invention, the pharmaceutical composition can be administered in to, a subject, wherein the subject is a mammal including a human. In yet another embodiment of the present invention, the route of administering the said pharmaceutical composition is selected from the group comprising intra-venous, intra-muscular and intra-peritoneal. In still another embodiment of the present invention, the said pharmaceutical composition can be alternatively administered into the cancer cells at a ratio of 0.1-0.5 μg of DNA per 50,000 cells in an in vitro system. In yet another embodiment of the present invention, the ratio of cationic lipid to biological molecule in the pharmaceutical composition is in the range of 1:1 to 8:1. Further in another embodiment of the present invention, the plasmid used could be of any construction. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a bar graph showing the influence of the dexamethasone associated lipid carrier carrying gene on the expression of a pCMV-β-galactosidase construct in A549 human metastatic lung cancer cells. A549 cells were transfected with a pCMV-β-galactosidase reporter construct (0.3 μg) associated in lipoplex form with respective lipid carriers DX and lipofectamine. β-galactosidase expression was assessed 48 h post transfection. Each value represents the mean±SEM for three identically treated samples. FIG. 2 is a bar graph showing the GR-mediated facilitation of gene delivery to A549 human lung cancer cells. The A549 cells were pretreated with RU-486, a GR antagonist and then transfected with pCMV-β-galactosidase vector complexed in lipid carriers. The β-galactosidase activity was evaluated 48 hr post transfection and expressed β-galactosidase unit per cell. Each value represents the mean±SEM for three identically treated cell wells and * indicates the significant difference between the β-galactosidase value obtained from cells pretreated and untreated with RU-486. (p<0.01) FIG. 3 is a bar graph showing the influence of the dexamethasone associated lipid carrier carrying gene on the expression of a pCMV-β-galactosidase construct in MCF-7 human primary breast cancer cells. MCF-7 cells were transfected with a pCMV-β-galactosidase reporter construct (0.3 μg) associated in lipoplex form with respective lipid carriers DX and lipofectamine. β-galactosidase expression was assessed 48 hr post transfection. Each value represents the mean±SEM for three identically treated samples. FIG. 4 is a bar graph showing the GR-mediated facilitation of gene delivery to MCF-7 human breast cancer cells. The MCF-7 cells were pretreated with RU-486, a GR antagonist and then transfected with pCMV-β-galactosidase vector complexed in lipid carriers. The β-galactosidase activity was evaluated 48 hr post transfection and expressed as β-galactosidase unit per cell. Each value represents the mean±SEM for three identically treated cell wells and * indicates the significant difference between the β-galactosidase value obtained from cells pretreated and untreated with RU-486. (* p<0.01 and + p=0.0109). FIG. 5 is a bar graph showing that there is no influence of the dexamethasone associated lipid carrier carrying gene on the expression of a pCMV-β-galactosidase construct in CHO (chinese hamster ovarian) transformed cells, which is in originality not a cancer cell line. CHO cells were transfected with a pCMV-β-galactosidase reporter construct (0.3 μg) associated in lipoplex form with respective lipid carriers DX and lipofectamine. β-galactosidase expression was assessed 48 hr post transfection. Each value represents the mean±SEM for three identically treated samples. FIG. 6 is a bar graph showing that there is no GR-mediated facilitation of gene delivery to CHO (chinese hamster ovarian) transformed cells, which is in originality not a cancer cell line. The CHO cells were pretreated with RU-486, a GR antagonist and then transfected with pCMV-β-galactosidase vector complexed in lipid carriers. The β-galactosidase activity was evaluated 48 hr post transfection and expressed as β-galactosidase unit per cell. Each value represents the mean±SEM for three identically treated cell wells and, indicates that there is no significant difference between the β-galactosidase values obtained from cells pretreated and untreated with RU-486. (p>0.1). FIG. 7 is a plot of size against time as determined in Example 6. FIG. 8 is a bar graphic showing the effect of cholesterol on the efficiency of transgene expressions as determined in Example 7. DETAILED DESCRIPTION OF THE INVENTION In the present invention, it has been determined that using an glucocorticoid pharmacologic agent in combination with a gene of interest provides a distinct improvement in the efficiency of gene delivery to cells which express glucocorticoid receptors as well as increasing the number of cells receiving the gene. In particular, dexamethasone, one of the most potent synthetic glucocorticoids, at mole ratios up to 3 compared to the cationic lipid, has been shown to facilitate the non-viral gene delivery of a variety of genetic constructs capable of performing their function (including apoptotic cell death) in human cancer cells. Therefore the present invention provides an aqueous formulation useful for selective targeting and delivery of genes to cancer cells, comprising: (a) a cationic lipid, (b) a steroid and (c) a neutral co-lipid characterized in enhancing the transfection efficiency and stability of the formulation, wherein the said cationic lipid, steroid and neutral co-lipid are mixed in the ratio in the range of 0.75:0.5:1 to 1:2:1 preferably 0.75:1:1 to 1:2:1. In a preferred embodiment of the invention, genes which can induce cell death are delivered via a non-viral route combination with glucocorticoid pharmacological compounds in order to provide more complete tumor emission and more effective prevention of tumor recurrence, thus leading to improved patient survival. The glucocorticoid pharmacological agent (e.g., dexamethasone) is to be administered via the same route of gene delivery, by incorporating it with the non-viral gene carrier (e.g., a cationic lipid coat). In this embodiment, four classes of genes may be used. First, cytotoxic genes such a tumor necrosis factor alpha or the tumor suppressor gene p53, which promotes apoptosis, can be provided. Second, genes which sensitize cells by enzymatically activating pro-drugs can be provided. For example, thymidine kinase or cytosine deaminase which respectively activate the cytotoxic pro-drugs gancylclovir and 5-fluorocytosine could be provided. Third, genes which promote immune surveillance could be provided. For example, tumor growth factor-beta 1 could be provided in combination with interleukin-2 and interferon-gamma. Fourth, antimetastatic genes, such as 5 E1A, could be provided. The idea of making this formulation stems from the fact that dexamethasone, a glucocorticoid, has close structural resemblance with cholesterol, a commonly used co-lipid present in many of the cationic lipids used for non-viral based gene delivery. The present invention provides a method for delivering genetic constructs via a non-viral mode with enhanced efficiency by co-formulating cationic lipid based gene delivery formulation carrying a glucocorticoid based pharmacologic agent along with the common co-lipid cholesterol. Cholesterol as a co-lipid has long been used in liposomal formulations. It is known that cholesterol-containing liposomes have greater stability and lower ion-permeability than when cholesterol is not used [Straubinger et al 1983, Cell, 32, 1069-1079]. In the event of lysosomal entrapment during cellular delivery the liposomal cargo is expected to be chewed up by the lysosomal degradative enzymes, such as nucleases, that work at pH<6. It is very much conceivable from the above known facts that cholesterol-associated liposomes not only provide a concrete integrity to the lipid-DNA complex in cytosol but also prevent diffusion of lower pH solution containing lysosomal nucleases inside the lipid-DNA core. The use of cholesterol increasing the stability of the genetic cargo and transfection efficiency is documented previously [Templeton et al. 1997, Nature Biotechnology, 15, 647-652; Xu and Szoka 1996, Biochemistry, 35, 5616-5623]. In the context the present invention stands with complete patentability because the formulation uses our own patented cationic lipid along side a secondary co-lipid dexamethasone, and a common, generic, glucocorticoid. The dexamethasone is not modified at all and is used as such. The concentration at which the dexamethasone is used did not induce any toxicity to non-cancer cells. The use of dexamethasone for the targeted gene delivery to cancer is not documented in any of these papers. Moreover, we for the first time showed that upon associating dexamethasone into cationic lipid formulation, the cancer cells are alone targeted leaving non-cancer cells untouched, even though the glucocorticoid receptors, through which dexamethasone works in cells, are ubiquitously present in all cells. The following examples are given by the way of illustration of the present invention and should not be construed to limit the scope of the present invention. Example 1 Glucocorticoid Receptor Expressing Cell-Specific Gene Delivery Properties of the Dexamethasone-Cationic Liposomal Formulation The in vitro transfection efficacies of DX liposome containing dexamethasone in combination with DODEAC as cationic lipid and cholesterol as co-lipid at a mole ratio of 0.75:1:1 were evaluated by reporter gene expression assay using pCMV-SPORT-β-gal plasmid as the reporter gene in A549, MCF-7 and CHO cells across the cationic lipid to DNA having charge ratios 8:1 to 1:1. Dexamethasone containing liposome DX has been found to be nearly 2-30 folds more efficient in transfecting A549 and MCF-7 cells (human cancer cells expressing glucocorticoid receptor) ( FIGS. 1 and 3 ) than CHO cell line. DX was most efficient in transfecting lung cancer cells A549 at cationic lipid:DNA charge ratios of 8:1 and 4:1 ( FIG. 1 ). Transfection efficiency of DX in A549 at 2:1 and 1:1 was at least 10-20 fold less than that of other charge ratios. However, DX was most efficient in transfecting breast cancer cells MCF-7 at cationic lipid:DNA charge ratios of 4:1, 2:1 and 1:1 ( FIG. 3 ). Both in A549 and MCF-7 cells, Lipofectamine™ mediate comparatively much less transfection in comparison to DX ( FIGS. 1 & 3 ). Significantly low levels of reporter gene expression were observed for DX in the otherwise highly transfectable, non-cancerous, transformed cell CHO across all the charge ratios studied with 8:1 and 4:1 giving the highest transfection efficiencies ( FIG. 5 ). Transfection efficiencies of other charge ratios are not shown. Lipofectamine™ as expected did show up very high transfection efficiency in CHO with respect to DX ( FIG. 5 ). The contrastingly enhanced □-galactosidase reporter gene expression level observed in both A549 and MCF-7 cells ( FIGS. 1 and 3 ) strongly indicate that transfection of glucocorticoid receptor expressing cancer cells, A549 and MCF-7 by DX is likely to be mediated by the glucocorticoid receptor-binding dexamethasone as present in formulation DX. Example 2 The transfection efficiencies of the DX formulation in transfecting glucocorticoid receptor expressing lung and breast cancer cells were significantly reduced when the gene transfer experiments were carried out by pretreating the cells with the RU-38486, the commercially available glucocorticoid receptor antagonists ( FIGS. 2 and 4 ) (p<0.01). Similar RU-38486 pretreatment studies in CHO cells yielded no significant change in transfection efficiencies ( FIG. 6 ) (p>0.1). Thus, the results summarized in FIGS. 1-6 provided strong evidence for the involvement of glucocorticoid receptors expression in breast and lung cancer cells for the present class of dexamethasone associated gene delivery reagents. Example 3 Materials used—Dulbecco's Modified Eagle medium (DMEM), fetal bovine serum was obtained from Sigma-Aldrich. Lipofectamine™ was obtained from Invitrogen. p-CMV-.beta.-galactosidase was a generous gift from Dr N. M. Rao, CCMB, India. Dexamethasone, RU-38486 were purchased from (sigma chemical co., St. Louis, Mo.) Cell-Culture—MCF-7, CHO, A549 cells were purchased from National Center for Cell Sciences (Pune, India) and were mycoplasma free. Cells were cultured in DMEM medium (Sigma Chemical Co., St. Louis, Mo.) containing 10% fetal bovine serum (Sigma Chemical Co., St. Louis, Mo.) and 1% penicillin-streptomycin at 370 C in a humidified atmosphere of 5% CO2 in air. Cultures of 85-90% confluency were used for all of the experiments. The cells were trypsinized, counted, subcultured in 96-well plates for transfection and viability studies. The cells were allowed to adhere overnight before they were used for experiments. Example 4 Liposome Preparation All the necessary compounds (for e.g. DODEAC, Cholesterol, DOPE, Dexamethasone) were taken as stock solutions and mixed in a sample vial in appropriate amounts. It was dried as a thin film in gentle nitrogen flow and further dried in high vacuum for 6 hrs. Then it was hydrated for overnight. After that it was subjected to bath sonication for 10-15 min and then probe sonicated at room temperature using a Ti-probe sonicator for 3-4 min to get SUV liposome. The liposomes were kept at 4° C. Plasmid Complexation & Gene Transfection— For a typical gene transfection study in vitro, cells were first seeded at a density of 12,000-15,000 cells/well in a 96 well plate usually 18-24 h before transfection. Plasmid DNA was complexed with cationic liposome typically in the following manner: 0.30 μg of pCMV-SPORT-β-gal DNA, a negatively charged entity (diluted to 50 μl with plain DMEM) was electrostatically complexed with varying amount of cationic liposomes (a positively charged entity, diluted to 50 μl with plain DMEM) for 30 min. The molar ratios (lipid:DNA) were 8:1, 4:1, 2:1 and 1:1. After the complexation of plasmid DNA and cationic liposome was completed, 200 μl of DMEM containing 10% FBS (CM1×) were added to the resulting lipoplexes for triplicate experiments. Thus the final concentration of serum became 6.7%. Cells were washed with phosphate-buffered saline (PBS), pH 7.4 (1×200 μl) and then with lipoplex (100 μl). After incubation of the cell plates at a humidified atmosphere containing 5% CO 2 at 37° C. for 4 hr, 100 μl of DMEM containing 10% FBS (CM1×) were added to cells. The reporter gene activity was assayed after 48 hr. The media were removed completely from the wells and cells were lysed with 50 μl of 1× lysis buffer (NP-40) for 30 min. The beta-galactosidase activity per well was estimated by adding 50 μl of 2× substrate (1.33 mg/ml of ONPG, 0.2 M sodium phosphate, pH 7.3 and 2 mM magnesium chloride) to the cell-lysate in the 96 well plate. Absorption of the product ortho-nitrophenol at 405 nm was converted to absolute μ-galactosidase units using a calibration curve constructed with commercial μ-galactosidase enzyme. Example 5 RU 38486 Pretreatment RU 38486 was dissolved in DMSO at a concentration of 10 mM. 1 μl of it were added to each well plate where cells were plated previously in 100 μl of DMEM+10% FBS. After 2 hr media were removed and cells were washed with PBS (1×100 μl) and treated with lipoplexes. Statistical Analysis—All experiments were repeated at least once. Data were expressed as mean±standard derivation and statistically analyzed by the two-tailed unpaired Student t-test using the Microsoft Excel software program (Microsoft, Seattle, Wash.). Data were primarily considered significant if p<0.01. Example 6 Effect of Cholesterol to the Stability of Liposome An experiment has been conducted to prove that indeed the cholesterol inclusion increases the stability of the liposomal formulation. The optimal formulation concentration that we used in our examples was 1:0.75:1 for DODEAC:DEX:Chol. We made a formulation devoid of cholesterol but having the same ratio of cationic lipid and dexamethasone. The new formulation is hence DODEAC:DEX, 1:0.75. The formulations were made 1 mM in concentration with respect to cationic lipid. 50 μl of each formulation was dispersed in 2 ml of phosphate buffer saline (PBS). PBS contains similar ionic strength and pH that prevails in a cellular environment. Then we proceeded to measure the size in Zetasizer (Malvern Instruments, U.K.) over the period of time as indicated in FIG. 7 . The data here indeed proves that the absence of cholesterol in cationic lipid formulation is detrimental for the size-stability of the liposome. The cholesterol-less formulation tends to increase in its size which might render it precipitate out in due course. In fact after 20 h it is noticed that the DODEAC:DEX (1:0.75) formulation indeed precipitated out, while the cholesterol-containing formulation [DODEAC DEX:Cholesterol::1:0.75:1] remained intact and showed no signs of precipitation. The wide range of literature related with cationic lipid mediated, gene transfection shows that the optimal size of the liposome showing efficient transfection should be in submicron level primarily because the lipid formulations with more than micron size will tend to precipitate out in long run rendering them incapable of carrying any bioactive molecules such as DNA in a near-soluble form. Moreover, a very big particulate matter will not be compatible in fusing with cellular membrane and hence will not be able to penetrate the membrane. In the same scenario, our cholesterol-formulated liposome does not change its size showing tremendous amount of stability and structural integrity of the formulation. Example 7 Effect of Cholesterol to the Efficiency of Transgene Expressions Two dexamethasone (DEX) associated cationic liposome formulations comprising with or without cholesterol (Chol) were made and proceeded to check their gene transfection efficiencies. The formulations were DODEAC:DEX:Chol (1:0.75:1) and DODEAC:DEX (1:0.75). The said formulations were respectively complexed with plasmid encoding β-galactosidase gene and fed to the cells. Following 4 h of lipid/DNA complex treatment the cells were washed and kept at normal cell culture conditions for 48 h, on completion of which the cells were washed, lysed and assayed for the β-galactosidase gene using o-nitrophenol-b-D-galactopyrano side (ONPG) substrate. The formation of o-nitrophenol is measured by measuring absorbance at 405 nm. The efficiency of transfection is directly proportional to the expression of transgene (here, β-galactosidase enzyme) that produces o-nitrophenol upon exposure with ONPG substrate. The results are shown in FIG. 8 . As the result shows that the cholesterol formulated cationic liposome could induce more transfection (2-4 folds) than cholesterol-less formulation. ADVANTAGES The process of the present invention can be exploited for preparing cationic lipid based gene transfer reagents containing glucocorticoid receptor binding dexamethasone in the formulation. The invention of this dexamethsone associated cationic lipid based gene delivery vehicle is useful for delivering polyanions, polypeptides or nucleopolymers into cells via glucocorticoid receptors. The formulation disclosed herein can be used to deliver an expression vector into a cell for manufacturing or therapeutic use. The expression vectors can be used in gene therapy protocols to deliver a therapeutically useful protein to a cell or for delivering nucleic acids encoding therapeutically useful protein molecules. The dexamethasone associated lipid based formulation can be formulated with anionic, zwitterionic and lipophilic therapeutic agents including anticancer agents such as doxorubicin hydrochloride, a hydrophilic compound, or Taxol™, a lipophilic compound to obtain complexes comprising the invented dexamethasone-associated formulation and a therapeutic agent(s). In the invented dexamethasone-associated cationic lipid based formulation, two classes of genes may be used. First, cytotoxic genes such a tumor necrosis factor alpha or the tumor suppressor gene p53, which promotes apoptosis, can be provided. Second, those genes can be provided which sensitize cells by enzymatically activating pro-drugs. For example, thymidine kinase or cytosine deaminase, which respectively activates the cytotoxic pro-drugs gancylclovir and 5-fluorocytosine. Third, genes that promote immune surveillance could also be provided. For example, tumor growth factor-beta 1 could be provided in combination with interleukin-2 and interferon-gamma. Fourth, antimetastatic genes, such as 5 E1A, could also be provided for killing metastatic cells.

1a

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0001] Not applicable. BACKGROUND [0002] 1. Field of the Invention [0003] The present invention relates to method and apparatus for playing a ball game. More specifically, the present invention provides for an apparatus that enables players to engage in a fast-paced game that combines aspects of the games of volleyball and foursquare while providing a game frame that is portable and deployable in a variety of environments. [0004] 2. Description of the Related Art [0005] There are several prior art variations of the traditional playground game of Four Square, but they share many of the same characteristics. Typically, the game is played with an elastic ball such as a rubber playground ball on a solid ground surface such as a concrete or asphalt playground or parking area. Referring to a top view of the prior art game square arrangement shown in FIG. 1A , a large square ( 10 ) is marked on a solid horizontal surface with a permanent medium such as paint, or with a temporary marking medium such as chalk. The large square ( 10 ) is approximately sixteen feet on each side ( 20 ) (or may be larger or smaller based on the skill of the players involved), and is further equally divided with orthogonal markings into four square interior play areas (A, B, C, and D). [0006] Referring to FIG. 1A and FIG 1 B, to begin play, four players ( 60 ) enter the large square ( 10 ) and each individual player ( 60 ) stands in one of the four interior play areas (A, B, C, or D). The player in interior square (or in the alternative, “box”) “D” is designated as the “server,” and places a foot in the small “service box” ( 40 ) within box D (or alternatively places a foot on the corner of the large square ( 10 ) nearest to the service box ( 40 )) and begins a rally by hitting the ball ( 50 ) by hand into any one of the other boxes (A, B, or C). Optionally, game rules may require the server to allow the ball ( 50 ) to bounce once in the server's box (D) before it is struck by hand to enter another internal play box (A, B, or C), and in one variation, the ball must be served into the box diagonally opposite (B) of the server's box (D). [0007] Once served, the ball enters one of the other internal play boxes (A, B, or C). It is allowed to bounce once, and then the player within the box that received the serve must strike the ball by hand, returning the ball so that it may bounce within another interior box before the ball bounces again. In one version of the game, a receiving player may hit the ball to another interior box before the ball bounces in that player's play box. The rally continues by players striking and returning the ball to other internal play boxes until a player is unable to successfully return the ball to bounce within another player's box. [0008] The player that is unable to correctly return the ball to another square is considered “out,” and leaves the game square ( 10 ), optionally moving to the end of a queue of waiting players ( 30 ). If the server was not the “out” player, the server then receives one point toward that player's individual score, with an overall goal of remaining as server and accruing points as long as possible. After the “out” player leaves the game square ( 10 ), players rotate counterclockwise (from A to D) to fill in the gap of the missing “out” player, and then a new player enters into box A from the front of the player queue ( 30 ). In this arrangement, play continues indefinitely with players rotating through the game as players go “out,” and additional players may join by simply joining the end of the player queue ( 30 ). [0009] Referring to FIG. 2 , a court ( 200 ) for the classic game of volleyball is shown. Volleyball may be played in areas such as grassy lawns and beaches, since the game does not require a ball to bounce from a solid surface. However, the game requires that a net ( 220 ) be erected in a manner that prevents it from falling over after being touched, impact from ball strikes, or from natural events such as wind. Further, the outside boundaries of the volleyball court ( 210 ) must be clearly demarked to assist in determining when a ball that hits ground was within the boundary or out of bounds. Yet in play areas such as sandy-beaches, court boundaries ( 210 ) can be difficult to create in a manner that resists scuffing, player footsteps, and ball strikes. The erection of a temporary volleyball court on a soft play surface therefore presents challenges that delay players' abilities to quickly begin a game, and once the game is begun, boundaries ( 210 ) may have to be periodically redrawn. [0010] What is needed, then, is a game that combines the excitement of volleyball with the rapid and fun game of four square. What is also needed is an apparatus that can be erected in a variety of playing environments without extended set up time. What is further needed is a gaming apparatus that is easily portable and breaks down to a size that lends itself to easy transportation and storage. What is further needed is a mechanism to create a foursquare-like game play area such as a beach or grass lawn that does not require a hard, completely flat surface with scuff-resistant edge indicia. What is further needed is an exciting, fast-paced interactive game that combines aspects of foursquare and volleyball, allowing for play on either hard or soft playing surfaces. SUMMARY [0011] In view of the foregoing, it is an object of the present invention to improve various problems associated with the prior art. More specifically, it is an object of the present invention to provide a portable game apparatus that enables players to perform a method of game play that combines aspects of volleyball and foursquare into a fun, exciting, multi-player game. To that end, the method and apparatus of the present invention provides a Four Square-like game that is played in the air above players' heads. By-providing for a portable, elevated game frame, player squares that are provided on a hard ground surface in Four Square are now elevated above the players' heads, and a player now uses volleyball-like ball strikes to hit the ball up and out of the players' game square and into another player's game square. Alternatively, the present invention may be viewed as a 4-way volleyball game without the need for nets or markings on the ground. [0012] Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. Thus, the present invention comprises a combination of features, steps, and advantages which enable it to overcome various deficiencies of the prior art. The various characteristics described above, as well as other features, will be readily apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments of the invention, and by referring to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0013] For a more detailed description of a preferred embodiment of the present invention, reference will now be made to the accompanying drawings, which form a part of the specification, and wherein: [0014] FIG. 1A depicts a plan view of a prior art Four Square game layout; [0015] FIG. 1B illustrates a view of a prior art Four Square game with players engaged in a rally; [0016] FIG. 2 illustrates a view of a prior art volleyball court; [0017] FIG. 3 illustrates one embodiment of the game frame apparatus of the present invention; [0018] FIG. 4 illustrates one embodiment of the game frame apparatus of the present invention, with players shown engaged in a rally; [0019] FIG. 5 illustrates correspondence with alternative embodiments of the game frame apparatus of the present invention; [0020] FIG. 6 illustrates plan views of exemplary alternate embodiments of the game frame apparatus of the present invention; [0021] FIG. 7 illustrates an implementation of an apparatus of the present invention in the early stages of collapsing for transportation or storage; [0022] FIG. 8 illustrates one embodiment of additional disassembly of the poles of the present invention; [0023] FIG. 9 illustrates an alternate embodiment of disassembly of the poles of the present invention; and, [0024] FIG. 10 illustrates another alternate embodiment disassembly of the poles of the present invention. DETAILED DESCRIPTION [0025] Reference will now be made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. [0026] FIG. 3 illustrates an overall conceptual view of one embodiment of the apparatus of the present invention, herein also referred to as the “game frame” ( 300 ). In one embodiment, the game frame ( 300 ) can be used as a game apparatus to play a game in which a projectile is projected among players. It is understood by those of skill in the art that such projectiles may constitute any number of objects that are adapted to play a game, such as a ball, a shuttlecock or “birdie,” a balloon, a beanbag, or a self-illuminated object. The game apparatus has at least three substantially equal volumes. Each volume is contiguous with each other volume and is sized sufficiently to be occupied by at least one player. Each volume is also bounded or otherwise defined by a plurality of elongate members that are above a playing surface. By way of example, and not by way of limitation, each or some of the elongate members can be a pole. At least some of the elongate members are positioned above the heads of the players. In the game, players project the projectile over the elongate members that are above the heads of the players. In one embodiment, the game apparatus also has means for connecting each elongate member so as to be substantially normal to at least one other elongate member. In an alternate embodiment, elongate members may be comprised of inflatable elastomeric members that assume a substantially rigid shape upon inflation. Also, the game apparatus has means, for at least some of the elongate members, for adjusting the length of the elongate member, and in an inflatable embodiment, the means for adjusting the length may comprise inflation or deflation. Each elongate member can be made of aluminum, steel, PVC, vinyl, polystyrene, polyethylene, nylon, or combinations thereof. [0027] Each said volume has a three dimensional (3D) shape. The 3D shape is defined by the linear movement of a 2D object, such as a rectangle, a circle, an octagon, a triangle, or a polygon. Thus, a linearly moved square (2D) forms a volume that is a cube (3D). [0028] The adjustment means can be one or more joints for moving the elongate member between an open and a closed position thereof. The closed position, for instance, can be a pole that is folded in half. The joint can be hinge or a bending member formed in the middle of the pole. The adjustment means can be capable of allowing the pole to be disassembled. Also, when a pole is made up of substantially concentric poles, the adjusting means can be for telescoping an inner pole within an outer pole. Also in the inflatable embodiment, the adjustment means may comprise inflation or deflation of an inflatable pole. [0029] For each volume, the connecting means and adjusting means respectively articulate to collapse the volume such that the plurality of elongate members thereof are parallel one to another. Also, the connecting means and adjusting means respectively articulate such that the plurality of elongate members can be moved into an operative position in which each elongate member is substantially normal to at least one other said elongate member, and a collapsed position in which each said elongate member is substantially parallel to each other said elongate member. Examples of the foregoing, for one embodiment, are seen in FIGS. 7-10 . In an alternate embodiment, the game frame ( 300 ) is allowed to be deployed through inflation from a substantially collapsed position to an operative position, and through deflation, the deployed game frame ( 300 ) may be collapsed. [0030] Each volume will preferably have a width and height suitable for the players. For instance, adults would prefer a width not less than four feet and a height not less than six feet. [0031] In yet another embodiment, the game frame ( 300 ) is comprised of horizontal bar members ( 350 ) substantially parallel to a ground or play surface interconnected to form an orthogonally-bisected square defining the top of four interior play boxes (A′, B′, C′, and D′) with one connection point ( 360 ) common to all four interior play boxes (A′, B′, C′, and D′). While one embodiment illustrated in FIGS. 3 and 4 is substantially symmetrical with respect to a vertical axis, other embodiments may be comprised of asymmetrical collections of volumes (or play boxes). [0032] The twice bisected square that defines the top of the game frame ( 300 ) is supported above the ground or play surface by four vertical corner poles ( 310 ), four mid-poles ( 320 ), and a center pole ( 330 ). The poles, together with the bar members and the bottom play surface, define a polyhedron-like shape, which further comprises the interior polyhedron volumes or play boxes (A′, B′, C′, and D′) that are occupied by players. The volumes defined by the interior play boxes (A′, B′, C′, and D′) may be contiguous or substantially contiguous, and one player is intended to occupy each volume. Each top side of an interior play box (A′, B′, C′, and D′) is comprised of two substantially horizontal bar members ( 350 ) hingedly or detachably connected at their midpoints by articulation points ( 340 ) comprised in one embodiment of locking bar hinges. In alternate embodiments, the articulation points are comprised of flexible bending points, friction-fit connections, double pin hinges, or snap-fit connections. In an alternate embodiment, each top side (A′, B′, C′, and D′) of the interior play boxes is not defined by two hingedly interconnected bar members, but a single rigid bar member, and in additional embodiments, the bar members ( 350 ) may further comprise two or more articulation points ( 350 ) for enhanced disassembly. In yet another embodiment, the game frame ( 300 ) is comprised substantially of inflatable elastomeric structural members, that deploy from a flaccid, portable collapsed shape, to a rigid or semi-rigid structure upon inflation. In such inflatable embodiment, bar members ( 350 ) and poles ( 310 , 320 , 330 ) may be permanently or detachably affixed to form the game frame ( 300 ). By operating a valve that is integrated with such bar members ( 350 ) or poles ( 310 , 320 , 330 ), the user may allow for deflation and subsequent storage of the game frame ( 300 ) in a substantially compressed condition. [0033] The bar members ( 350 ) that do not reside on the outside edge of the game frame ( 300 ) not only serve to add structural integrity to the game frame ( 300 ) but also provide a barrier over which a projectile ( 50 ) (for instance, a ball, a birdie, or another object) must pass during play, much as a volleyball must pass over a net. The projectile may be projected by a player simply by throwing, kicking, punching, or hitting it, or by a player hitting the projective by a bat, a racket, a stick, a paddle, or another instrument. Preferably, the projectile is a ball that is manually projected by the players among themselves over the barrier and into each respective player's play box or volume. [0034] Each interior play box is further comprised of one outside corner ( 370 ), two mid-corner proximal connections ( 380 ) and a connection ( 360 ) proximal to the center pole ( 330 ). While in one embodiment the poles ( 310 , 320 , 330 ) may be rigid and incapable of folding, in an alternate embodiment, the poles ( 310 , 320 , 330 ) further comprise a take-down element ( 345 ) whereby the poles may be shortened in length through a flexible bending point, a locking hinge-fold mechanism, or through a concentric inner pole element capable of telescoping into and out of a hollow outer element of the pole. While bar members ( 350 ) may be permanently connected to poles ( 310 , 320 , 330 ), in one embodiment, bar members ( 350 ) are attached to the poles ( 310 , 320 , 330 ) through a friction fit socket, or in another embodiment, bar members ( 350 ) attach at outside corners ( 370 ), central T-junctions ( 380 ) and the central four-way junction ( 360 ) through hingedly-movable connections. Takedown and disassembly of the game frame is discussed in more detail below. [0035] In one embodiment, poles ( 310 , 320 , 330 ) and bar members ( 350 ) may be manufactured from tubular steel, aluminum, PVC, polystyrene, polyethylene, nylon, vinyl, or any substance that is sufficiently lightweight to be person-portable yet rigid enough to be self-supporting and resistant to bend forces induced by ball or player strikes. In an alternate embodiment, poles ( 310 , 320 , 330 ) and bar members ( 350 ) may be manufactured from transparent material, wherein light strings such as miniature Christmas-type bulbs or LED lights are contained within the poles and bar members to light the structure and alternatively to provide ambient light for night-time play or decoration. Alternatively, the poles and bar member may be manufactured from either semi-transparent or partially transparent material, and string lights are molded into a channel within each frame member. In another embodiment, poles and bar members further comprise channels substantially aligned with the central axis of the poles and bar members, wherein LED lights and wiring strings are retained within the channel by a friction fit, a set of clamps, or conventional adhesives. In an alternate embodiment, the lighting system further comprises an electronic control unit that provides a pulsed signal to the lights, so that various patterns of flashing and/or multicolor display may be achieved, such as provided by prior art synchronous Christmas “chaser” lights. [0036] Referring to FIG. 5 , the shape of the game frame ( 300 ) need not be limited to twice-bisected square or rectangular polyhedrons. Rather, many embodiments are possible whereby an arrangement ( 300 A) of poles ( 510 ) and bars ( 500 ) define contiguous or substantially contiguous interior volume spaces that provide sufficient room for players to move and return projectiles over the top bar members of the game frame to other game boxes. Plan views of the top surface of exemplary embodiments are shown in FIG. 6 , and comprise a square bisected at its vertices rather than midpoints ( 610 ), a twice-bisected circle ( 620 ), an octagon crossed with bars at its vertices ( 630 ), a rectangle defining a plurality of interior game spaces, such as six spaces ( 640 ), and a triangle ( 650 ) defining three interior game box spaces. In most cases, poles will attach to each vertex created by the intersection of the bar members and shapes shown on FIG. 6 . The three-dimensional shapes formed by a hypothetical outside implied surfaces stretched along such top surfaces and poles could be a rectanguloid, cylinder, extruded octagon, extended rectanguloid, or extruded triangle, respectively. [0037] In one embodiment of the game frame illustrated in FIG. 3 , the length of the poles ( 310 ) is approximately seven feet, and each interior game box (A′, B′, C′, and D′) measures eight feet on each horizontal side, making the overall outer dimensions of the polyhedron defined by the game frame approximately 16 feet by 16 feet by seven feet high. While this embodiment provides for one play configuration, other dimensions may be easily provided for, such as if the poles ( 310 ) were decreased in length to allow an embodiment that was easier to play for short children. In one embodiment, in a manner similar to camera tripod legs, the poles ( 310 ) may be shortened to a desired play length through a telescoping action provided by pole take-down elements ( 345 ). Those of skill in the art also may recognize that the dimensions of the interior game boxes may be varied from the exemplary eight feet by eight feet to accommodate available play space or differing players' ability. [0038] In one embodiment, the projectile ( FIG. 4, 50 ) may be a rubber playground ball, or may be a typical play ball found in most toy sections of stores, such as balls with approximately ten-inch diameters and weighing approximately 95 grams. Alternatively volleyballs may be utilized as the game ball ( 50 ), and if the outside environment is being subjected to significant wind, a partially-deflated volleyball can offset the wind-induced shear forces, allowing for more enjoyable play. Generally, lighter balls provide for longer rallies and are better adapted to players of lower ability, while heavier balls provide more challenge and are more resistant to wind effects. [0039] Turning now to FIGS. 7, 8 , 9 , and 10 , the game frame apparatus ( 300 ) in FIG. 3 will now be shown in various stages of disassembly. In FIG. 7 , downward force ( 700 ) is applied to the articulation points ( 340 ) so as to hingedly bias bar members ( 350 ) downward as shown in the arrows ( 700 ). As the bar members ( 350 ) rotate downward, the game frame ( 300 ) collapses inwardly in an accordion-like manner ( 710 ). Once the game frame ( 300 ) has collapsed inwardly, ( FIGS. 8, 9 , 10 , items 801 , 901 and 951 , respectively) the bar members ( 350 ) and poles ( 310 , 320 , 330 ) come into close proximity in a bundle that eases transportation of the game frame. In one embodiment, to further shorten the bundle of rods and poles to improve portability, poles (shown as 310 , but may also comprise poles 320 or 330 ) may be further folded ( FIG. 8, 802 ) by rotating a bottom section of poles through a hinged joint ( FIG. 8, 345 ). In an alternate embodiment ( 902 ) shown in FIG. 9 , bottom sections of poles ( 310 , 320 , 330 ) slide in a telescoping manner ( 900 ) into larger upper chambers through an aperture to a larger outer top tube ( 345 ), which in outer deployed position could have been fixed by a clamp, rotating friction collar, set screw, or pin. In yet another embodiment ( 952 ) shown in FIG. 10 , bottom sections of poles ( 310 , 320 , 330 ) detach from the top sections of the poles, and while held together with elastic or stretchable lines ( 345 ) are capable of being folded vertically to join the bundle of bar members and poles ( 952 ), in a manner not unlike many disassemblable tent support poles in modern backpacking tents. As a result, the fully disassembled game frame ( 300 ) forms a dense and readily transportable bundle ( 803 , 903 , 953 ) that may be slid within a tote bag or carry box. [0040] In an alternate embodiment, the articulation points ( 340 ) on the top surface of the game frame ( 300 ) do not hingedly connect; rather, bar members ( 350 ) separate at the articulation points ( 340 ) through fastening means such as friction fit or pin-fastened connections, and then bar members ( 350 ) are free to rotate downward through hinged communication with corner junctions ( 360 , 370 , 380 ), and each pole ( 310 , 320 , 330 ) separates from the game frame with either two, three, or four bar members ( 350 ) hingedly attached. [0041] Referring to the apparatus shown in FIG. 4 , the method of game play is now described. Initially, four players stand individually in play boxes (A′, B′, C′, and D′). The player ( 460 ) that stands in the D′ box (the serving box or volume) is identified as the serving player, and touches one foot to the outside corner pole ( 410 ). The rally begins with other non-serving players ( 465 ) standing in their respective play boxes and awaiting the serve. The serving player ( 460 ) either strikes or pushes the ball ( 50 ) with a volleyball-like hand motion up and out of the serving box so that the ball ( 50 ) lands in one of the other players' ( 465 ) boxes (A′, B,′ or C′, or the “nonserving” boxes). The player ( 465 ) that receives the served ball must return it up and out of their box and down into another player's box. The rally continues until a player ( 460 or 465 ) allows the ball to touch the bottom play surface ( 420 ) inside or outside of the game frame ( 300 ) without successfully returning it over the top of a bar member into another player's box. That player is then “out,” must exit the game frame, and return to the end of the queue ( 30 ) of people ( 60 ) waiting to enter box A′. Without passing the D′ box, the other players then rotate counter-clockwise to fill in the volume or play box that was vacated by the “out” player, and then the person at the front of the queue ( 30 ) enters box A′, thus causing all play boxes (A′, B′, C′, and D′) to be occupied by a player. Once a player rotates into play box D′, that player becomes the new serving player and receives a point each time a rally ends where another non-serving player ( 465 ) is “out.” The first player to receive ten points wins the game, and a new game may then be started. [0042] In one embodiment of the method of the present invention, the serving player ( 460 ) should observe the following rules when serving: (a) one of the serving player's feet should be in contact with the outside corner pole ( 410 ), (b) the serving player ( 460 ) should annunciate that player's current score aloud before serving, and (c) the serving player ( 460 ) should serve the ball into another player's ( 465 ) box (A′, B,′ or C′) without the ball ( 50 ) touching any of the game frame's horizontal bar members (or barriers) as shown by the two exemplary bar members ( 350 ) in FIG.4 . If the serving player ( 460 ) fails to observe the aforementioned rules, the serving player is considered “out” and must leave the serving player box (D′). Rotation and new player entry then occurs as described above. During the course of a rally, it is permissible for the ball ( 50 ) to deflect off of any number of horizontal bar members ( 350 ) as long as it ultimately comes down inside of some other player's box. [0043] Although an exemplary, preferred embodiment of this invention has been described using preferred commercial products, it will be readily understood by those skilled in the art that modifications of the methods and apparatuses described, as well as substitution of equivalent commercially available products may be made without departure from the spirit and scope of the invention claimed.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to filters for smoking articles and more particularly to filtering devices for controlling the amount of smoke drawn through a smoking article such as cigarettes, cigars and the like. 2. Description of the Prior Art Various types of filters have been designed for removing or reducing undesirable constituents in the smoke from smoking articles. Most commonly, such filters take the form of a mass of fibers, paper or other porous and semiporous materials through which the smoke must pass, thereby entraining some of the constituents present in the smoke. Other types of smoke filterng devices have been proposed which utilize valves or various designs which tend to open upon a predetermined amount of suction being applied by the smoker when drawing on the smoking article. Typical devices of this nature are disclosed in U.S. Pat. Nos. 2,709,441; 3,533,414; 3,616,802; and 3,685,522. However, filter valves of this type have the disadvantage of increasing the amount of smoke drawn through the smoking article as the pressure or suction is increased by the draw in any individual puff, thereby opening the valve and thus increasing the amount of smoke and attendant constituents passing through the valve to the smoker. Cigarette filter devices have also been proposed that contain valves which are designed to close by the hot smoke from the approaching coal as the cigarette is smoked and thereby reduce the amount of smoke that can be drawn through the cigarette, particularly in the last half of the cigarette. Examples of this type of filter valve are disclosed in U.S. Pat. No. 3,800,805. However, such valves have the disadvantage that they are responsive to the heat from the smoke and only operate to close when the heat gets high enough or the burning coal close enough to activate the valve. At all other times the valve remains open without any restriction placed upon the amount of smoke that can be drawn through the cigarette. All of the foregoing disadvantages become important when considered in light of the new lower tar and nicotine cigarettes currently being produced. Many smokers in order to achieve the same level of nicotine they have been accustomed to tend to draw harder with a greater volume of smoke in each puff, thereby obtaining a greater yield of nicotine and tar in each puff and defeating the purpose for which the such cigarettes were designed. Accordingly, it is an object of this invention to provide a smoke control device for smoking articles and the like not having the disadvantages of the above prior art filter devices. Another object of this invention is to provide a smoke control device which will limit the volume of smoke that can be drawn in any puff depending upon the pressure drop or rate of draw induced by the smoker. SUMMARY OF THE INVENTION In accordance with this invention, a smoke control device is provided containing a valve means responsive to pressure drop in any puff such that as the puff draw rate exceeds a predetermined level the valve closes, thereby limiting and controlling the amount of smoke that can be inhaled in each puff. The structure is designed so that only a normal puff can be taken on the smoking article for the valve to remain open and when a greater rate is attempted by the smoker the valve automatically closes. After each puff, the valve returns to its open position and remains open unless an excessive pressure drop occurs in the next puff whereby it closes again. From the foregoing it can be seen that the delivery of tar and nicotine in each puff is limited to the delivery that would normally be obtained from the smoking article such as a low tar/nicotine cigarette and cannot be increased by the smoker by increasing the draw rate in any single puff. BRIEF DESCRIPTION OF THE DRAWINGS In order that the invention may be more readily understood and carried into effect, reference is made to the accompanying drawings and detailed description thereof, which are offered by way of illustration only and not in limitation of the invention, the scope which is defined by the appended claims rather than any description preceding them. In the drawings: FIG. 1 is a perspective view partially in section showing one type of flap valve in the open position in a cigarette mouthpiece. FIG. 2 is a cross section of the mouthpiece showing the valve of FIG. 1 taken along lines 2--2 of FIG. 1. FIG. 3 is a view of the same mouthpiece as FIG. 1 with the valve in the closed position. FIG. 4 is a perspective view partially in section showing another embodiment of a flap valve in the open position in a cigarette mouthpiece. FIG. 5 is a section of the mouthpiece showing the valve of FIG. 4 taken along lines 5--5 of FIG. 4. FIG. 6 is a view of the same mouthpiece as FIG. 4 with the valve in the closed position. FIG. 7 shows another embodiment of a flap valve similar to the preceding views with the valve in the open position. FIG. 8 is a section of the mouthpiece of FIG. 7 taken along lines 8--8 of FIG. 7. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the embodiment illustrated in FIGS. 1, 2, and 3, the mouthpiece portion of a cigarette is shown comprising a tobacco column 11, wrapped in cigarette paper 12 to which is affixed a filter plug 13 by tipping paper 14. Within the tube formed by tipping paper 14, there is positioned a circular member 15 abutting filter plug 13 and of equal diameter thereto containing a movable flap valve 16 which in the open position of FIG. 1 bends into chamber 17 within the tube. When flap 16 is bent, an opening 18 is provided in member 15. The contiguous surfaces of member 15 and filter plug 13 may be affixed together by an adhesive or glue to assure that the member is held in the proper position within the tipping paper tube. Member 16 is made of material that is substantially air impermeable and, therefore, impervious to the gaseous and particulate vapors drawn through the cigarette such as tars, nicotine, and vapor phase constituents normally present in tobacco smoke. Typically suitable materials are paper, preferably heavier gauge cigarette tipping paper, and flexible plastic films such as cellophane, polyethylene, polypropylene, and the like. Flap 16 is cut out of the center of member 15 along three sides and bent or folded on the fourth side along line 19 such that it is normally in the open position. The materials employed for member 15 should be sufficiently resilient so that flap valve 16 will return to the open position shown in FIG. 1 from the closed position shown in FIG. 3 when pressure on the valve is removed. Operation of the valve is uncomplicated and provides a positive means of controlling volume and rate of draw on the cigarette in any single puff, thus limiting the amount of nicotine available to the smoker. As shown in FIG. 1, arrow 21 indicates the normal path traveled by the smoke through the cigarette starting with tobacco column 11, through chamber 19, opening 18 provided by flap valve 16, and thence through the porous filter medium of filter plug 13 before entering the smoker's mouth. As long as the pressure drop or volume and rate of draw in any puff is normal, flap valve 16 remains open. However, if the pressure becomes excessive, flap valve 16 closes as shown in FIG. 3, preventing further smoke from reaching the smoker's mouth in that puff. When the pressure is released at the end of the puff, the flap automatically returns to the open position shown in FIG. 1, again allowing smoke to be drawn through the cigarette on the next puff. In FIGS. 4, 5, and 6, another embodiment of the invention is shown in which like parts of the cigarette and mouthpiece of FIG. 1 are referred to with like numerals. Thus, within the chamber 17 between filter plug 13 and tobacco column 11 is positioned a circular member 22 having a rectangular opening 23 cut in its center section as shown by the dotted lines in FIG. 5. Shoulder 24 at the outer periphery of member 22 is provided to adhesively seal the member to the inner wall of tipping paper 14 and hold it in position within chamber 17. A flap valve 25 slightly larger than opening 23 is positioned over the opening and glued to member 22 along one side. A bend or crease along line 26 allows the valve to be normally open. The same materials described above to make circular member 15 in FIG. 1 may be used to make member 22 and flap valve 25. Alternately, the entire assembly comprising member 22 and valve 25 may be molded from a plastic polymer material with shoulder 24 extending in both directions to form a tubular piece coextensive in length with the distance between the end of the tobacco column and the filter plug or if a filter plug is not employed of sufficient length to reach the end of the cigarette mouthpiece. As shown more clearly in FIG. 6, when excessive pressure is applied by the smoker in any puff, flap valve 25 closes preventing further smoke from passing through the cigarette, thus limiting the nicotine yield in that puff. A similar embodiment is shown in FIGS. 7 and 8 in which a circular opening 27 is provided in member 25 overlaid by a slightly larger circular flap valve 28 glued at tab 29 to member 25. In this embodiment, the device is made of the same materials and functions in the same manner as the embodiments heretofore described. The pressure drop in a normal puff on a cigarette will vary depending on the smoker between 3 to 10 inches of water at 17.5 cc per second air flow. Accordingly, and in order to prevent an excessive draw in any one puff on a cigarette or other smoking article, the flap valves of this invention are preferably designed to close whenever the pressure drop exceeds 10 inches of water at 17.5 cc per second air flow. Of course, it is apparent that they can be designed to close at lower or higher pressure drops depending upon the specific requirements of the smoking article. Also, while all of the drawings illustrate the flap valve in combination with a filter plug, it is to be understood that valves according to the invention can be employed with or without a filter and with a variety of smoking articles such as cigarettes, cigars, pipes, etc., where a smoke control limiting means would be desirable. It will thus be seen from the foregoing description that an improved smoke control device is provided to limit the delivery of nicotine and tar in any single puff on the smoking article to that obtainable in a normal puff. Although the invention has been described in conjunction with the preferred embodiments and drawings, they are only illustrative of the invention and it is to be understood that many variations and modifications may be resorted to without departing from the spirit and scope of the invention, as those skilled in the art will readily understand.

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BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] Present invention relates medical polymer materials sterilized by radiation and their ways in use, particularly medical polymer materials showing small deterioration or decomposition by time passage by being exposed to radiation such as γ ray or a microwave. [0003] 2. Description of the Related Art [0004] There are many kinds of raw materials employed as medical use, in which furthermore functional materials are expected to employ in medical field, notwithstanding metals, ceramics and polymers are pointed out as biomaterials. Properties of medical material includes sterilization in product stage as important factor, adding to desirable functions of medical material. [0005] Sterilization is defined in Japan Pharmacopoeia as sterilizing or removing all microbes in materials. There are 12 methods of 5 groups in sterilized methods pointed out in Japan Pharmacopoeia, in which sterilized methods by high pressure vapor, ethylene oxide gas (EOG) and radiation are widely and generally employed as living body. [0006] As sterilized condition of high pressure vapor is applied about 20 minutes at 121° C. of 1.0 kg/cm 2 G saturated vapor pressure in relative simple auto-crave, it is possible to be employed in sterilization of such many kinds of medical materials of standing at high pressure and temperature. However sterilized methods are employed in almost no case of organic polymer materials, caused on deterioration or decomposition, while many kinds of metals and ceramics are possibly stood in high pressure and temperature. [0007] On the other hand, speaking to EOG sterilized method, sterilization instruments are developed in order to improve effective, efficient and safety in sterilization, because EOG is known effective as a disinfectant. Moreover, sterilized method seems best in comparison with others in order to prevent EOG sterilization from deteriorating the raw materials, But EOG sterilized method recently come to avoid employing, because it is pointed out that EOG remains in medical materials after sterilization, and has bad effect on living body. [0008] According to recent research, sterilized method employed in suture for operation, disposable surgical gown and a hypodermic syringe, comes to change from usual EOG to radiation sterilized methods, because of high toxicity of residual EOG and complicated packing. [0009] Radiation sterilized method is took attention as other sterilized method, in which radial rays are such beam as particles including light, coming from radioactive disintegration and composing of α, β, γ rays, neutron and X ray. General beam for the sterilized method applying for medical polymer material, is known to employ γ ray coming from 60 Co and electron beam. [0010] As γ and electron beams have no serious damage to general-purpose polymer materials such as polyethylene, polypropylene, polyethylene chloride, polystyrene and synthetic rubbers, those polymers are possible to sterilize by radiation and have widely applied in their case until quite recent. [0011] However, it is pointed out that coloration, bad smells and oxidation for worse, happen to occur on passage of time, caused on generally sterilized irradiation amount of about 25 kGy, new sterilized methods such as plasma and ultra-violet methods are developing. The plasma and ultra-violet methods are partly applied as a simple and easy method, but has a very narrow application caused on permeability. [0012] Radiation exposed effects on the polymer materials are distinguished by cross-linking and collapse of the polymer chains, independent on irradiated rate, but proportional to irradiated dose over wide range. Cross-linking is defined that radicals are generated by irradiation process, in which new connections are generated inner- and intra- polymer molecules, molecular weight of the polymer finally increases until infinity, and the cross-linked polymer is insoluble in all kinds of solvents. On the other hand, the collapse of the polymer is defined that polymers happen to deteriorate their molecular weight and mechanical properties, because the polymer chains are cut by irradiation. [0013] The polymers are classified in cross-linked and collapsed type polymers dependent on radiation effect. Typical examples of cross-linked polymer are pointed out as polyethylene, polypropylene, nylon, polystyrene, polyester, natural rubber and silicon resin. On the other hand, collapsed type polymers include poly-methyl-methacrylate, Teflon, poly-isobutylene, collagen, cellulose and bio-decomposed polymers such as poly-lactic acid. However, even cross-linked type polymers happen inevitably to deteriorate mechanical properties similar to the collapsed type because the both polymer chains are generated radicals and cut by irradiation. Therefore, even polyethylene of easiest cross-linked polymer by radiation happens to deteriorate mechanical properties by time passage after irradiation. It is because radicals generated by irradiation do not extinct in short time, but remain long time as free radicals in raw material and cause to cut polymer chain by reacting with oxygen by passage time. [0014] The polymers are heat-treated at higher temperature than 100° C. in order to remove these free radicals. However, when the polymers are heat-treated several hours at higher temperature than 100° C. in order to fabricate cup and plate for artificial hip and knee joints from ultra high molecular weight poly ethylene (UHMWPE), there is fear of deforming the product by remained strain. [0015] Many polymer materials made of polypropylene sterilized by radiation are available for disposable medical materials such as suture for operation, hypodermic syringe, filter, surgical gown, and non-woven sheet. It is proposed the methods of compounding the propylene with hydrated rosin-methyl-ester (JOP Sho61-213243) or styrene resin (JOP Hei7-157922) in order to prevent deterioration and bad smell from sterilizing by radiation. However, it is not quite effective because the free radicals can not completely be removed from by the above additives. [0016] Only several kinds of polymers including polypropylene and polyethylene are available for sterilizing by radiation among many cross-linked types of decomposable and bio-absorbable polymers. Reason why radiation sterilized method is not employed in even radiation cross-linked type polymers of nylon or poly-vinylidene fluorite, is because the polymers happen to partly cross-link each others and partly decompose at same time, generate oligomers and monomers, and cause toxicity. Furthermore, we cannot employ the method on the suture for surgical operation, in which there is request of mechanical properties maintaining in long time because of toxicity problem. Recently, notwithstanding poly methyl methacrylate and silicon resin are generally employed on contact lenses and ocular lenses according to excellent optical properties and biological adequate, EOG sterilization is inevitable in end product because radiation is hazard. It is problem that EOG remains in medical materials after sterilization. As eye is the most sensitive organ in comparison with other organs and tissues, it is afraid to give further bad effect on living body. [0017] On the other hand, medical polymer materials for implantation recently include suture for operation made from decomposable and bio-absorbable polymer, artificial dure mater, bonding agent for broken bone and is expected to increase various uses. In spite of a fact that it passed more than 30 years since the suture for operation made from decomposable and bio-absorbable polymer was applied in clinic, EOG sterilized method is still employed. It is because the decomposable and bio-absorbable polymer is originally composed of chemical structure that is unstable in heat, light, radiation and moisture. [0018] Sterilized methods by high pressure vapor of EOG and radiation are widely and generally employed as living body as mentioned above. What the targets of present invention are to solve the following problems of radiation sterilized method, seem to be brightest future. [0019] (1) Prevention of medical material deterioration caused on irradiation. [0020] (2) Expansion of used way of radiation sterilized method until medical materials that are impossible to be employed in past. [0021] Moreover, if it is possible to sterilize in decomposable and bio-absorbable polymer by radiation, we cannot guess that effect. Especially, if it is possible to apply radiation sterilized method for decomposable and bio-absorbable polymer that are impossible for medical use in past, we cannot guess the usefulness in social and economical scopes. SUMMARY OF THE INVENTION [0022] Present invention provides medical material sterilized by radiation, comprising polymer composite using in living body, containing multifunctional triazine compounds at weight ratio range of 0.01 to 20 weight percent to the polymer. [0023] The present invention shows the fabrication of polymer composite having good heat and radiation resistance, by preventing heat molding record and irradiation on sterilized processes from deteriorating molecular weight caused on heat and radiation decomposition of the polymer. It is possible that the polymer composite is applied for the medical field of decomposable and bio-absorbable polymers and even bio-nonabsorbent polymers such as suture of operation or bonding agent for broken bone as a result. Furthermore, it is possible that the polymer composite is applied for not only medical material but also food wrapping material of industrial use. DETAILED DESCRIPTION OF THE INVENTION [0024] The inventor of the present report has found after wholeheartedly researching above subject that all kinds of polymer material composites including triallyl isocyanurate compound that is one of multi-functional triazine group compounds, preventing the polymer from cutting, decomposing their chains and forming cross-linkage between polymer chains, and preventing from generation of bad smells and deterioration of mechanical properties by irradiation, although the polymers seem to be impossible caused on producing stage after molding by irradiation. Medical material the polymers according to the present invention are selected from both bio-absorbable and undecomposed polymer, and bio-nonabsorbable polymer materials [0025] Medical materials of bio-absorbable and decomposed polymer according to the present invention, include natural polymers selecting of collagen, gelatin, chitin, chitosan, silk, cellulose, hyaluronic acid, microbe-produced polyester such as poly-β-hydroxybutylate, albumin and dextrin, and bio-absorbable and decomposed synthetic polymers selecting of poly-glutamine, poly glycolic acid, poly-lactic acid, poly caprylic acid, poly dioxanon, tri-methylene carbonate, and their co-polymer such as glycolic acid-caprylic acid copolymer, lactic acidcaprylic acid copolymer, lactic acid-dioxanon copolymer, glycolic acidtri-methylene carbonate copolymer, or poly peptide, poly phosphatase, poly butylene succinate and their blends. [0026] On the other hand, as medical material according to present invention, polymer is selected from bio-nonabsorbable and undecomposed polymer materials consisting of poly propylene, poly ethylene, poly amide, poly ester, poly carbonate, poly fluorovinylidene, silicon, poly urethane, natural rubber, synthetic rubber, poly vinylchloride, poly acetal, poly styrene, styrene resin, poly acrylonitrile, poly tetra-fluoro-ethylene, ethylene-vinyl-alcohol copolymer, ethylene-vinylacetate copolymer, poly methylmethacrylate, poly hydroxyethyl methacrylate, and poly sulphone, or their blends. [0027] Cross-linking agent of the polymer applied in present invention is the multi-functional triazine compound. Triallyl isocyanurate, triallyl metha-isocyanurate, triallyl(2,3 di bromo) isocyanurate include in triazine compound and triallyl isocyanurate is preferred based on reactive monomer. [0028] The triazine compound is added 0.01 to 20 weight percent, preferably 0.1 to 10 weight percent to the polymer before molding polymer material as fabricating method of medical material. It is preferred to fabricate uniform product quality caused on adding the triazine compound before molding. [0029] Cross-linking between polymer chains is achieved by irradiation of 10 to 50 kGy at final producing stage after molding. It is not preferred because deterioration starts with higher than 50 kGy irradiation, and sterilization effect is shortage at lower than 10 kGy irradiation. [0030] Furthermore, it is possible to blend the polymer and known heat stabilizer, antioxidant, ultraviolet absorbent, light stabilizer, colorant, antistat, lubricant, nucleating agent, fire retardant, filler within limit of not spoiling effect of the present invention. For example, it is effective to blend the polymer and antioxidant such as vitamin E or catechin. [0031] Medical material according to the present invention is the ways in use, employing on suture for operation, artificial blood vessel, bonding agent for broken bone, dental material, wound protector, artificial skin, contact lenses, ocular lenses, artificial ligament, artificial valve, artificial joint scraping parts, mesh, medical non-woven, stint, clip, Hotchkiss, artificial dure mater, scafford in tissue regeneration, provender from adhesion, anatomosis splint, disposable hypodermic syringe, catheter, blood bag for infusion, tube, disposable surgical gown and glove, forming product, sheet and filter. [0032] The medical materials of the present invention are possible to apply for not only medical uses, but also industrial uses including packing or wrapping. It is possible to improve mechanical properties and bio-decomposability based on irradiation for sterilization and cross-linking between polymer chains at final producing stage after molding in products of the industrial uses. EXAMPLE [0033] We explain details of the present invention according to following examples, however, not restricting the scope of the invention by the explanation. [0034] Test procedure of the tensile strength and elongation was performed according to deification of JIS L1017. We have examined the specimen by employing tensile-tester of Shimazu Auotogragh 100 type, in room maintained constant temperature of 25° C., humidity of 65 RH %, at spacemen length of 250 mm and test speed of 300 mm/min. Example 1 [0035] Polypropylene pellet composed of weight-average molecular weight of about 320,000, is added triallyl cyanurate of 2.0 weight percent, melt-spinning by simple type spinner and drawing 4 times by warm air circular type stretching machine. Produced polypropylene fiber was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further irradiating electron ray of 25 kGy. [0036] Irradiated fiber showed properties of non-soluble but swelling in heated xylene, and gelation ratio of about 0.75, caused by having cross-linking structure. And tensile strengths and elongations at break of the fiber before and after irradiation, were 5.7 g/d and 31%, and 6.1 g/d and 29%, respectively. Comparative Example 1 [0037] Polypropylene pellet was melt-spun by simple type spinner, same to example 1, but without adding triallyl cyanurate, melt-spinning by simple type spinner and drawing 4 times by warm air circular type stretching machine. Produced polypropylene fiber was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further irradiating electron ray of 25 kGy. [0038] Irradiated fiber showed properties of soluble in heated xylene, and gelation ratio of about 0 percent. And tensile strengths and elongations at break of the fiber after irradiation, were 3.2 g/d and 21%. Example 2 [0039] Poly vinylidene fluorite pellet composed of weight-average molecular weight of about 680,000, is added triallyl cyanurate of 1.0 weight percent, melt-spinning by simple type spinner and drawing 5 times in polyethylene bath at 150° C. Produced poly vinylidene fluorite fiber was packed in Aluminum/Polyethylene laminated bag under decompressed pressure, further irradiating Co60 γ ray of 25 kGy. [0040] Irradiated fiber showed properties of non-soluble but swelling in dimethyl formamide, and gelation ratio of about 0.68, caused by having cross-linking structure. And tensile strengths and elongations at break of the fiber before and after irradiation, were 5.8 g/d and 27%, and 6.2 g/d and 25%, respectively. Comparative Example 2 [0041] Poly vinylidene fluorite pellet was melt-spun by simple type spinner, same to example 2, but without adding triallyl cyanurate, melt-spinning by simple type spinner and drawing by warm air circular type stretching machine. Produced polypropylene fiber was packed in Aluminum/Polyethylene laminated bag under decompressed pressure, further irradiating Co60 γ ray of 25 kGy. [0042] Irradiated fiber showed properties of soluble in heated dimethyl formamide, and gelation ratio of several percents. And tensile strength and elongation at break of the fiber after γ ray irradiation, were 3.9 g/d and 20%. Example 3 [0043] Dried nylon 6 pellet composed of weight-average molecular weight of about 55,000, is added triallyl cyanurate of 0.8 weight percent, melt-spinning by simple type spinner and drawing 4 times by sandwiching between 2 heated rollers. Produced nylon 6 fiber was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further sterilizing with respect to irradiating electron ray of 25 kGy. [0044] Irradiated fiber showed properties of non-soluble but swelling in heated m-cresol, and gelation ratio of about 0.66. And tensile strengths and elongations at break of the fiber before and after irradiation, were 6.3 g/d and 29%, and 6.8 g/d and 27%, respectively. Comparative Example 3 [0045] Nylon 6 pellet was melt-spun by simple type spinner, same to example 3, but without adding triallyl cyanurate, melt-spinning by simple type. Produced nylon 6 fiber was packed in Aluminum/Polyethylene laminated bag under decompressed pressure, further irradiating electron ray. [0046] Irradiated fiber showed properties of soluble in heated m-cresol, and gelation ratio of 0 percent. And tensile strength and elongation at break of the fiber after electron ray irradiation, were 5.2 g/d and 23%. Example 4 and Comparative Example 4 [0047] Dried poly methylmethacrylate pellet composed of weight-average molecular weight of about 120,000, is added triallyl cyanurate of 2.0 weight percent, forming columns of 20 mm diameter and 10 cm length by injection molder. After cutting the column to shape of ocular lens, produced poly methlmethacrylate column was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further sterilizing with respect to irradiating Co60 γ ray of 25 kGy. [0048] Irradiated specimen showed properties of non-soluble but swelling in tetrahydrofuran, and gelation ratio of about 0.70. On the contrary, vacuum bag specimen (comparative example 4) that was formed and cut from injected column without adding triallyl cyanurate, and irradiated Co60 γ ray of 25 kGy, was happened to turn yellow and bad smell caused on the decomposition, and was deteriorated to show the weight-average molecular weight of about 80,000. Example 5 [0049] Dried poly dioxaone (Hexa-fluoro iso propanol HFIP) solution composed of instrinsic viscosity of 2.5, is added triallyl cyanurate of 2.5 weight percent, getting monofilament fiber by spinning by simple type spinner, drawing and annealing. Produced monofilament fiber was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further sterilizing with respect to irradiating electron ray of 25 kGy. [0050] Irradiated monofimament fiber showed properties of non-soluble but swelling in heated HFIP, and gelation ratio of about 0.77. And tensile strengths and elongations at break of the fiber before and after irradiation, were 7.7 g/d and 36%, and 4.8 g/d and 35%, respectively. Comparative Example 5 [0051] Poly poly dioxaone was melt-spun by simple type spinner, same to example 5, but without adding triallyl cyanurate, melt-spinning by simple type spinner, drawing and annealing. Produced monofilament fiber was packed in Aluminum/Polyethylene laminated bag under decompressed pressure, further irradiating electron ray. [0052] Irradiated monofilament fiber showed properties of soluble in HFIP , and gelation ratio of 0 percent. And tensile strengths and elongations at break of the monofimament fiber after electron ray irradiation, were 3.1 g/d and 22%. Example 6 [0053] Dried poly L lactide (PLLA) pellet composed of weight-average molecular weight of about 340,000, is added triallyl cyanurate of 1.0 weight percent, forming rod columns of 10 mm diameter and 10 cm length by injection molder. After solid-extruding the rod column at 140° C. and as extruding ratio of 4, produced poly L lactide column was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further sterilizing with respect to irradiating Co60 γ ray of 25 kGy. [0054] Irradiated column showed properties of non-soluble but swelling in methylen chrolide and gelation ratio of about 0.67. And bending strengths the column before and after irradiation, were 250 and 260 MPa, respectively. Comparative Example 6 [0055] PLLA was formed by injection molder, same to example 6, and solid-extruded the rod column but without adding triallyl cyanurate. Produced PLLA was packed in Aluminum/Polyethylene laminated bag further irradiating Co60 γ ray of 25 kGy. [0056] Irradiated PLLA showed properties of soluble in methylene chrolide, and gelation ratio of 0 percents. And bending strength after γ ray irradiation, were deteriorated until 180MPa. Example 7 [0057] Ultra high molecule poly ethylene (UHMWPE) powder composed of weight-average molecular weight of about 4,500,000, is added triallyl cyanurate of 1.0 weight percent, forming plate of 10 mm thickness by hot-press molder. Produced UHMWPE plate was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further sterilizing with respect to irradiating Co60 γ ray of 25 kGy. [0058] Irradiated plate showed properties of non-soluble but swelling in hot tetralin solvent and gelation ratio of about 0.79. And abrasion resistance index evaluated by pin-on-flat tester before and after irradiation, were 0.9(×10 −10 g/Nm) and 0.2(×10 −10 g/Nm), respectively. Further, abrasion resistance index of 0.2 was not changed after oxidation test performed at 80° C. in ambient air at one week. Comparative Example 7 [0059] Ultra high molecule poly ethylene (UHMWPE) powder composed of weight-average molecular weight of about 4,500,000, without adding triallyl cyanurate, was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further sterilizing with respect to irradiating Co60 γ ray of 25 kGy. [0060] Irradiated plate showed properties of non-soluble but swelling in hot tetralin solvent and gelation ratio of about 0.58. And abrasion resistance index evaluated by similar method of example 7, is 0.6(×10 −10 g/Nm), however, abrasion resistance index of 14 was increased after oxidation test. Example 8 [0061] Dried poly glycolic acid pellet which showed η sp/c of 1.4 at 170° C. in solvent mixture of phenol(10) and 2.2.6 tri-chloro-phenol(7) in weight percent ratio, was added triallyl iso-cyanurate of 1.0 wt. percent, melt-spinning by simple type spinner, drawing, annealing and fabricating multifilament yarn. Produced multifilament yarn was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further irradiating electron ray of 25 kGy. [0062] Irradiated multifilament yarn showed properties of non-soluble but swelling in solvent mixture at 170° C. and gelation ratio of about 0.48. And tensile strengths and elongations at break of the fiber before and after irradiation, were almost same values of 7.2 g/d and 22%. Dried poly glycolic acid pellet added no triallyl iso-cyanurate, melt-spinning by simple type spinner, packing in Aluminum/Polyethylene laminated bag, showed the degradation of tensile strength and elongation at break as 3.8 g/d and 17%. Example 9 [0063] Dried lactic acid and caproic acid copolymer pellet composed of weight-average molecular weight of about 420,000, was added triallyl iso-cyanurate of 1.0 wt. percent and vitamin E of 0.2 wt/percent, melt-spinning by simple type spinner, drawing, annealing and fabricating monofilament yarn. Produced monofilament yarn was packed in Aluminum/Polyethylene laminated bag replaced by nitrogen gas, further irradiating electron ray of 25 kGy. [0064] Irradiated monofilament yarn showed properties of non-soluble but swelling in chloroform and gelation ratio of about 0.53. And tensile strengths and elongations at break of the fiber before and after irradiation, were almost same values of 5.7 g/d and 36%. [0065] Dried lactic acid and caproic acid copolymer adding no triallyl iso-cyanurate, melt-spinning by simple type spinner, packing in Aluminum/Polyethylene laminated bag, showed the degradation of tensile strength and elongation at break until 2.9 g/d and 21%.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation U.S. application Ser. No. 14/009,195 filed Nov. 13, 2013, which, in turn, is the U.S. national phase of PCT Application No. PCT/GB2012/000288 filed on Mar. 30, 2012, which claims priority to Great Britain Patent Application No. 1105622.3 filed on Apr. 1, 2011, the disclosures of which are incorporated in their entirety by reference herein. TECHNICAL FIELD [0002] The present invention relates to novel catheters suitable for delivering an electric current to the body, in particular to catheters that have electrodes that can be positioned independently of the main elongate shaft of the catheter. More particularly the invention relates to catheters that include a movable sleeve that incorporates the electrodes. It also relates to a movable sleeve that includes one or more electrodes and to advances in the construction of the electrodes and related components. The invention also relates to methods for positioning electrodes at a treatment site in the body for diagnostic or therapeutic applications. BACKGROUND [0003] Catheters that include electrodes that are used for diagnosis, measuring and other medical applications are well known, catheters comprising multiple electrodes, for example, see U.S. Pat. No. 5,109,870 Silny. Whilst catheters comprising electrodes are known in the art, they suffer from a number of disadvantages. [0004] International patent publication No. WO 2006/024825 (Hamdy) discloses a catheter for assisting recovery from dysphagia including a catheter for insertion into the body of a patient via the mouth or nose, a particularly useful application of the devices of the present invention. The electrodes are in the elongate shaft of the catheter such that when the catheter is in a suitable position within the patient's body, the electrodes are in a position to apply electrical pharyngeal stimulation. [0005] The present inventors have, however, found that accurate positioning of the catheter disclosed in Hamdy can be problematic. The catheter is required to fulfil two functions—firstly to safely and effectively deliver nutrition to the patients' stomach via an internal lumen of the elongate shaft of the catheter and secondly to deliver electrical stimulation to a defined region of the oropharynx via electrodes on the outer surface of elongate shaft of the catheter. The incorporation of both functions into the main body of the catheter has advantages, it minimize s patient discomfort and is consistent with existing standards of care in that it replaces a conventional nasogastric (NG) feeding tube and can be introduced into the patient in the same way as a conventional NG tube. [0006] The fixed position of the electrodes has, however, been found by the inventors to have some disadvantages. The catheter must be inserted into the patient so that the distal end is correctly positioned in the stomach to meet the requirement to safely and effectively deliver nutrition. The correct insertion distance can vary considerably dependent on the height of the patient and can routinely be different by 20 cm or more from patient to patient. In contrast, the optimal position for the electrodes in the oropharynx is within a 2-3 cm vertical distance range. Thus, in order to ensure that the electrodes on the elongate shaft of the catheter are correctly positioned there must either be a range of catheter sizes to accommodate the variation in patient height, or the catheter must be designed to be sufficiently long for the tallest anticipated patient and then over inserted into shorter patients in order to bring the electrodes into the correct position. This introduces risks that the distal end of the catheter does not remain in the stomach but continues into the duodenum, becomes entangled in the stomach preventing effective nutrition delivery or easy removal, or re-emerges from the stomach into the lower esophagus. [0007] The fixed positioning of both electrical stimulation and nutrition functions in the invention of Hamdy et al. also has the disadvantage that, in the event the internal lumen of the catheter becomes blocked with nutritional feed in a way that cannot be resolved, the entire catheter must be replaced. [0008] In addition, it has become apparent that once the treatment with electrical stimulation has been completed it may still be necessary to keep the catheter in place solely for the purposes of enteral nutrition. This is not desirable from a patient comfort or safety management perspective. It would be particularly advantageous for these reasons to be able to remove the electrical stimulation functionality, whilst leaving the nutrition delivery functionality in place. SUMMARY [0009] The present inventors have now determined that a catheter that comprises the electrodes in a separate, movable electrode carrying component provides significant advantages to the accurate positioning of electrodes that are used to deliver electric current to the body. Thus the present invention provides a catheter for delivering an electrical stimulus to the body comprising an elongate shaft; a sleeve incorporating one or more electrodes, the sleeve being movable along the elongate shaft such that the position of the sleeve is adjustable; and a means to fix the sleeve to the elongate shaft once the sleeve is in position. [0010] Thus the present invention provides advantages over current catheter designs by permitting the incorporation of more than one function into a single catheter and allowing each of the functions to be independently positioned and optimized. Thus the catheter comprises an elongate shaft that may incorporate at least one therapeutic or diagnostic function. The catheter may thus comprise at least one diagnostic or therapeutic function in both the elongate shaft and the sleeve. The elongate shaft may have a therapeutic function such as the provision of enteral nutrition, and the sleeve has electrical stimulation electrodes. The catheter may incorporate other diagnostic functions such as pressure or pH sensors. [0011] The catheter of the present invention may also be configured such that it allows for selective removal of certain functional components once they are no longer required, or in the event that their functionality becomes compromised. For example, the catheter can be configured such that the electrode carrying sleeve can remain in the body when the elongate shaft is removed. [0012] It is also possible to configure the catheter such that the sleeve can be removed leaving the elongate shaft in the body. [0013] Examples of catheters according to the present invention that incorporate more than one function include: [0014] A catheter for electrical stimulation comprising a sleeve with electrodes for the delivery of a stimulus and an elongate shaft with sensors to detect the effect of the stimulus delivered. Thus the catheter combines an electrical stimulation function in the sleeve and a diagnostic function in the elongate shaft to measure the effect of the stimulus. Such a catheter may be configured such that the elongate shaft is movable. [0015] This allows the effect of the stimulus to be assessed at a number of different positions without moving the point of stimulation. Alternatively the point of stimulation can be moved by moving the sleeve. [0016] A catheter for the delivery of electrical stimulation comprising a sleeve with one set of stimulating electrodes and an elongate shaft with a second set of stimulating electrodes. This would have the advantage of allowing the distance between stimulation points to be adjusted as required but also keeping one stimulation point fixed if needed. [0017] A catheter for measurement comprising a sleeve incorporating electrodes wherein the electrodes are sensors to measure for example pressure, EMG signals or pH and a core elongate structure with sensors to measure for example pressure, EMG signals or pH. This arrangement would provide the possibility to measure the same parameters at a fixed and user controlled variable location simultaneously or measure two different parameters at a fixed and user controlled variable location simultaneously. One example of a useful application using this arrangement would be the measurement of lower esophageal sphincter strength and separately the measurement of pH at multiple points along the esophagus. [0018] A catheter for the delivery of electrical stimulation and the measurement of pressure, comprising a sleeve that incorporates one or more electrodes to deliver electrical stimulation, and an elongate shaft incorporating pressure sensors. The pressure sensors can be positioned on the elongate shaft such that they can be used to measure upper esophageal sphincter pressure. This arrangement would help to inform the user whether the distal end of the catheter was in the upper airway or in the esophagus by virtue of pressure readings from the upper esophageal sphincter and facilitate the correct placement of stimulation electrodes in the pharynx or esophagus rather than in the airways. [0019] A catheter in the form of a two part catheter for the delivery of electrical stimulation and measurement of pH comprising a sleeve with electrodes to deliver electrical stimulation and a core elongate structure that was capable of extending as far as the patients' stomach and incorporating pH sensors at its distal end. This arrangement would help to inform the user whether the distal end of the catheter was in the airways or in the esophagus by virtue of pH readings from the patients' stomach and facilitate the correct Placement of stimulation electrodes in the pharynx or esophagus rather than in the airways. [0020] Another example would be a catheter for the delivery of electrical stimulation and nutrition, comprising a sleeve with electrodes to deliver electrical stimulation and an elongate shaft in the form of a nasogastric feeding tube. This catheter could be used to treat dysphagia, particularly acute dysphagia, whilst also maintaining a safe supply of nutrition to the patients' stomach. [0021] Thus the catheter of the present invention may be a pharyngeal stimulation catheter for the treatment of acute or chronic dysphagia. [0022] Dysphagia is the condition whereby a patient has difficulty in swallowing, or is unable to swallow. Dysphagia may be caused, for example, by stroke, neurodegenerative diseases, and brain tumors or in some cases by other co-morbidity such as respiratory disorders. Dysphagia may be an acute condition arising due to acute neurological damage following stroke or traumatic brain injury (TBI) and managed in a hospital setting. Dysphagia may also be a persistent or chronic condition (defined as remaining present for periods greater than 6 weeks after initial onset). This could be due to non-recovery from a stroke or TBI induced deficit, it could be a feature of a progressive neurodegenerative disease such as Parkinson's disease or it could be a feature of a condition such as cerebral palsy or multiple sclerosis. In this case management is most often outside of a hospital setting. Dysphagia, whether acute or chronic, is a life threatening condition primarily due to the development of respiratory infections arising from the uncontrolled entry of food and liquids into the airways. [0023] Dysphagia after stroke carries a six-fold increase of aspiration pneumonia by comparison with stroke patients without dysphagia. [0024] It is envisaged that a pharyngeal stimulation catheter according to the present invention may have several, different configurations depending whether it is for the treatment of patients with an acute dysphagia or chronic dysphagia. For example where a patient is presenting with dysphagia post stroke in an acute care hospital environment it is likely the patient will also require nutrition delivery via an enteral feeding tube. A configuration of the device to combine nutrition delivery capability with the ability to also delivery therapeutic electrical stimulation to the pharynx is therefore particularly advantageous for an acute dysphagia patient. It is envisaged that this configuration of the catheter for treatment of dysphagia and for nutrition delivery will used in a hospital environment, will incorporate a feeding tube and be in place for relatively long periods of time (up to 29 days). An alternative configuration particularly suited to treating patients with chronic dysphagia would not require the incorporation of an enteral feeding tube but would have different functional requirements reflecting the context of care i.e., potentially community based rather than in a hospital setting. The main function of the elongate shaft in this case would be to facilitate placement of the electrode carrying sleeve at the treatment site. [0025] In the configurations where the elongate shaft is a nasogastric (NG) tube the elongate shaft may incorporate a visual position indicator on its external surface. The elongate shaft may also include connectors suitable for engagement with an enteral feeding set. [0026] However, as will be apparent to the skilled man, and as described above, it is envisaged that the catheters of the present invention, will be useful in other therapeutic or diagnostic applications, particularly when it is desirable to adjust the position of the electrodes relative to the position of the elongate shaft and or to accurately position electrodes at a treatment or diagnostic site. [0027] Examples of the kind of functionality that may be incorporated into the elongate shaft or the sleeve of the catheter include but are not limited to electrodes, sensors, transducers, wires, conducting materials, active chemical surface coatings, lubricants, balloons or stents. [0028] The sleeve is dimensioned to permit it to move with respect to the elongate shaft. The sleeve may be dimensioned such that when the catheter is in position in the body the sleeve extends to the outside of the body. This is advantageous as it permits the position of the sleeve to be adjusted from outside the body. It also means that the sleeve can be positioned by the health care professional without the need for a separate mechanism in the catheter to deploy or adjust the sleeve. Thus the sleeve position can be adjusted manually. [0029] Typically, the sleeve is a substantially transparent flexible tube made of polyurethane, PVC, polyamide, silicone or equivalent material. The sleeve is dimensioned to permit it to move with respect to the elongate shaft, thus it is sized to have a larger internal diameter than the external diameter of the elongate shaft. For example, if the elongate shaft is an adult nasogastric feeding tube, the dimensions of the sleeve will be approximately 5 mm in outer diameter, with an internal lumen of approximately 3 mm diameter and for approximately 35-45 cm in length. This arrangement is particularly suitable for a pharyngeal stimulation catheter for the treatment of acute dysphagia. It will be apparent to the skilled man that the dimensions of the sleeve may vary depending on the patient population to be treated. For example, the feeding tube may be 8F and the sleeve 14F. [0030] The sleeve may incorporate one or more pairs of ring electrodes and conducting elements disposed laterally along the walls of the sleeve connected to the electrodes. The walls of the sleeve may include pre-formed lumen for the conducting elements (wires). Thus the sleeve may be formed by multi-lumen extrusion. The sleeve may then be constructed by inserting the wires into the appropriate lumen. The wires may be coated with an insulating material such as FEP (Fluorinated ethylene propylene) or the like. [0031] The sleeve may also include a device, for example a Y connector, to guide the wires to an electrical connector. [0032] The sleeve may be adapted to help it to slide over the elongate shaft. The sleeve and/or elongate shaft may be modified by coating with a lubricant, by modification of surface hardness, by incorporation of surface features, or otherwise to allow free relative movement of sleeve along the length of the elongate shaft both whilst outside and inside the patient. [0033] The internal surface of the sleeve may be modified with respect to its hardness, shape, finish or coating such that the modification helps to minimize friction when the sleeve is placed or moved along the elongate shaft on which it is positioned. [0034] The sleeve may have a position indicator, for example a visual indicator such as printed guide or window on its surface to facilitate its positioning relative to the elongate shaft. [0035] It is possible to configure the catheter such that the sleeve can be removed leaving the elongate shaft in the body. Such an arrangement is particularly advantageous in the treatment of acute dysphagia, where the elongate shaft functions as a feeding tube. [0036] A further feature of the invention is wherein the distal end of the sleeve is shaped to minimize patient discomfort. This shaping may comprise a graduated or rounded end to ensure the sleeve does not disturb the tissue during insertion or removal. [0037] An important feature of the present invention is that the provision of a separate sleeve and elongate shaft allows a single catheter to be used where otherwise two or more might be required. In addition the present invention provides a catheter comprising movable sleeve and elongate shaft and a position indicator, the position indicator providing a means to accurately position the catheter in the body. [0038] Thus the catheter according to the invention may include a position indicator arranged to indicate when the sleeve is correctly positioned on the elongate shaft. Typically the sleeve includes a position indicator; however, it may be advantageous if both the sleeve and the elongate shaft include a position indicator. The catheter may comprise a position indicator arranged to indicate when the sleeve is located correctly in respect of the elongate shaft and is thus in a predetermined position within a patient. [0039] Position indicators according to the present invention may comprise visible markings on an exterior surface of the sleeve and/or elongate shaft, such as a guide or scale on a surface of the sleeve to indicate vertical and/or lateral placement. The guide or scale may provide a number of indicators depending on the patient to be treated, for example, male or female and vertical distance ranges based on patient height. Such guides or scales may be based on placement of the sleeve. In a preferred embodiment there is a printed window on the sleeve which lines up with a printed guide on the elongate shaft identifying the insertion distance. For example, in a pharyngeal stimulation catheter configured for acute use, the distance from the windows to the electrodes will be in the range of 14 cm and 17 cm to ensure that the electrodes will be in the correct position within the patient when the catheter is inserted. The catheter may incorporate more than one position indicator, for example, more than one window which may optionally be color coded to cater for the different applications and sizes of patient or the route of catheter insertion (oral or nasal). [0040] It will be apparent to one skilled in the art that the position indicators may be combined with other catheter functions that provide diagnostic information to facilitate correct placement of the electrodes. For example a catheter for pharyngeal stimulation may incorporate a position indicator in the form of a visual guide on the sleeve and/or elongate shaft and also a pressure sensor to detect the high pressure zone in the upper esophagus sphincter of the patient. The pressure sensor may be incorporated into the sleeve or the elongate shaft of the catheter. Other suitable sensors include CO2, moisture content or pH sensors. [0041] The catheters of the present invention have a sleeve that can move relative to the elongate shaft, the catheter also having a means to fix the sleeve in position. It may be advantageous if this fixing means is reversible. Thus after the sleeve is fixed in position on the elongate shaft it is still possible to release the fixing means to make further adjustments to the position of the sleeve and/or remove the sleeve or elongate shaft. The fixing means may be engaged before or after insertion into the patient. Advantageously, the fixing means is located at the proximal end of the sleeve. [0042] The fixing means, for example in the form of a clip, may form part of the sleeve or be mounted thereon. The fixing means may be positioned at the proximal end of the sleeve. However, particularly for a pharyngeal stimulation application, the fixing means may be in the form of a clip that is located externally of the body, i.e. at the proximal end of the sleeve/elongate shaft, when the catheter is in position in the body. Thus the catheter of the invention comprises a clip for fixing the position of the sleeve relative to the elongate shaft, said clip being located at the proximal end of the catheter. [0043] Ideally the fixing means also functions to seal any gaps between the sleeve and elongate shaft, for example, when the clip is located at the proximal end of the sleeve, to prevent liquid or material ingress between the sleeve and the elongate shaft. [0044] When not fixed in position the sleeve is capable of freely moving along the length of the elongate shaft. Advantageously, the fixing means may be positioned at the proximal end of the sleeve and thus may remain accessible to the operator when the catheter is inserted into the body. The fixing means, may form part of a Y-connector assembly and therefore part of the sleeve if the sleeve incorporates a Y-connector. For example, the proximal end of the sleeve may be attached to a connector, which incorporates the fixing means, the fixing means acting on the elongate shaft, e.g. NG tube, to secure the position of the sleeve relative to the elongate shaft. This permits the user to move the shaft relative to the sleeve and then engage the fixing means to secure the sleeve. The connector may also incorporate a conduit to guide the wires to a suitable electrical connector. The connector may be in the form of a Y-connector as discussed above. An example of such a connector arrangement is shown in FIG. 5 . [0045] Alternatively, the fixing means may be a feature independent of but connectable to a Y-connector. [0046] The fixing means may take the form of a reversibly engageable clip fixed to the sleeve and capable of gripping the elongate shaft, for example by virtue of ridges or equivalent on its inner surface. It may also operate in a similar fashion to a Touhy-Borst valve whereby a connector on the sleeve contains a deformable O-ring which can be reversibly compressed. In this way it is possible to hold or release the elongate shaft which runs through the center of the O-ring. The reversibly engageable clip or fixing means may also take the form of a collet that grips the elongate shaft, or interference ribs or wave form that grip the shaft. [0047] The fixing means may engage with the elongate shaft to fix the position of the sleeve. The fixing means may include resiliently deformable materials such as deformable silicone or the like. The fixing means may be fabricated from this type of material, for example, in the form of compliant silicone grommet. Alternatively, the deformable material may be used to coat the portions of the fixing means that engage with the elongate shaft, particularly if the elongate shaft is an NG feeding tube. If a deformable material such as a silicone or equivalent is used it can have two useful features—it deforms to spread the applied load and it creates friction such that the applied load can theoretically be less. These are both advantageous as a uniform loading and lower applied pressure reduces the chance that the feeding tube gets deformed and the cross sectional area of the lumen is compromised (leading to increased risk of blockage). [0048] Thus the fixing means, particularly a reversible fixing means, may comprise a resiliently deformable material, for example a deformable silicone or the like. The fixing means may be formed from or coated with the resiliently deformable material. [0049] Catheters according to the present invention may also include means for connecting said electrodes to a power supply such as the wiring junction, for example, in the form of a Y-connector or the like, as described above. The means for connecting may be incorporated into the fixing means. In a catheter used for pharyngeal stimulation this facilitates removal of all of the electrical stimulus components upon removal of the sleeve. [0050] Thus the catheter according to the present invention may comprise an elongate shaft, a sleeve incorporating one or more electrodes, the sleeve being movable along the elongate shaft such that the position of the sleeve is adjustable; and a reversible means to fix the sleeve to the elongate shaft once the sleeve is in position, the sleeve being attached at its proximal end to a connecter and the connector including a means for connecting the electrodes to a power supply and the means for fixing in the form of a reversible fixing means capable of gripping the elongate shaft to fix the sleeve to the elongate shaft once the sleeve is in position. [0051] The invention also provides advances in the incorporation of electrodes into catheters by significantly improving the configuration of the electrode components into a device for insertion to the body. [0052] In a further aspect, the sleeve comprises multi-strand conducting elements extending along a length of the sleeve and terminating in at least one electrode. Particularly the multi-strand conducting element comprises steel. More particularly, the conducting element is a multi-strand steel wire. [0053] In the past, single stranded copper wire has been utilized in catheters, however, the inventors have discovered that copper wire can have a number of significant disadvantages. Particularly, conventional copper wire is not robust enough at the appropriate diameter and when arranged so that is attached to the surface of the sleeve may easily detach from the surface of the tube leading to puncture hazard. It also breaks more easily, leading to failure of the electrode. In addition, copper is more malleable meaning that the wire exhibits differential stretching causing bunching or, again, wire detachment. However, insulated copper wire may be used, particularly if inserted into a lumen in the wall of the sleeve. Thus the catheter according to the present invention may comprise a sleeve with a wall incorporating molded lumen carrying wires to the electrodes. [0054] Multi-strand steel coiled wire is strong and more rigid with a reduced risk of beading or bunching and breakage. Such wire adapts to the curvature of the anatomy and negates the requirement for a separate guide wire. Surprisingly, when co-extruded, the adhesion between the steel wire and the sleeve is stronger or greater than that of a comparable copper wire. Multi-strand wire means that each electrode comprises more individual connections—if one wire fails, the electrode continues to function. [0055] The inventors have identified a multiplicity of advantages in using multi-strand steel wire over more commonly used copper wires for these applications, specifically; The wires confer greater rigidity to the sleeve enhancing the process of catheter insertion. [0056] Locating the wires on either side of the sleeve confers directional conformity to the catheter (i.e., the sleeve will only easily bend in one plane) and therefore simplifies printing and use of surface guides. [0057] The multi-strand steel wire is considerably stronger and forms a better bond with the sleeve walls than copper. These features significantly reduce the risk of wire breakage, leading to product fault or puncture injury to the patient, and also prevent differential stretching of wire and sleeve walls leading to bunching or wire detachment. [0058] This inventive concept therefore has application in either a novel sleeve according the present invention or may be incorporated into a more traditional catheter. In a further aspect of the present invention there is provided a catheter for delivering an electrical stimulus to the body comprising a sleeve adapted to move over an elongate shaft wherein the sleeve comprises multi-strand conducting elements extending along a length of the sleeve and terminating in at least one electrode, the wire may be multi-strand steel wire. [0059] In another independent aspect there is provided a catheter comprising multi-strand steel conducting elements extending along a length of the catheter and terminating in at least one electrode. [0060] The catheter as described above may be used for delivering an electrical stimulus to the body comprising applying electrical pulses capable of inducing stimulation to electrodes located on the surface of an elongate shaft or sleeve, the catheter being inserted into the body of a patient and the electrodes being located in a position suitable for applying electrical stimulation to the target tissue or organ. [0061] The catheter of the present invention has significant advantages over the known devices and solves many of the problems associated with them. In particular the device is well adapted for the incorporation of nasogastric feeding tubes. [0062] Firstly it separates nutritional and stimulation functionality to allow both to be positioned optimally on a per patient basis. This separation also allows the nutrition component to be removed and replaced if required (due to blockage) whilst retaining the stimulation component located on the sleeve within the body. Leaving the sleeve in the body is advantageous in that it facilitates replacement of the feeding tube by providing a conduit or guide to aid introduction of the tube. This greatly simplifies the procedure for replacing the tube as there is virtually no risk of accidentally inserting the tube into the airways. It also means that the final position of the NG tube need not be confirmed by X -ray. The presence of the sleeve also aids accurate vertical positioning of the replacement tube. [0063] Separate nutritional and stimulation functionality also allows for the stimulation function, i.e. electrode carrying sleeve, to be removed from the patient on completion of electrical treatment, whilst the feeding tube remains in position in the patient. [0064] One of the primary design challenges for a catheter intended to be used to deliver an electrical stimulation inside the body is to identify mechanisms to safely and easily introduce the sleeve and in particular the electrodes to the correct location in a manner most easily tolerated by the patient. Simple controls and confirmatory feedback should provide confidence to users that the device has been safely and successfully positioned. The device once placed should be secure, as comfortable as possible and capable of supporting minor adjustments to maximize electrode contact in the correct location. [0065] Nasal insertion has the advantage of avoiding some of the areas that induce a gagging response in patients. [0066] Oral insertion has the advantage of allowing some direct visualization of the path followed by the catheter and device and is considered somewhat less invasive. It is more subject to inducing a gag response and more likely to result in unwanted movement of the catheter and device once it is placed. [0067] International patent publication No WO 2006/024825 Hamdy discloses a device for assisting recovery from dysphagia including a catheter for insertion into the body of a patient via the mouth or nose. The catheter comprises electrodes positioned such that when the catheter is in a suitable position within the patient's body, the electrodes are in a position to apply electrical pharyngeal stimulation. [0068] In a further aspect of the present invention there is provided a catheter as described above for use in delivering an electrical stimulus to the body to assist recovery from dysphagia. The catheter comprises a sleeve adapted to move over an elongate shaft, one or more electrodes incorporated into said sleeve, means to fix the sleeve to said elongate shaft once in position and means for connecting said electrodes to a power supply. [0069] When in use for this purpose the sleeve is positioned such that when inserted into a patient the electrodes are in a suitable position for applying electrical pharyngeal stimulation. In a further aspect the catheter may comprise a means to facilitate correct positioning of the electrodes in the form of a diagnostic sensor such as a pressure sensor. The sensor may be included in the sleeve or the elongate shaft. The pressure sensor may be for the measurement of the high pressure zone in the upper esophagus sphincter of the patient. [0070] The catheter may comprise a means to confirm correct positioning of the catheter and/or the electrodes in the form of a pH sensor. Ideally, the pH sensor is incorporated into the elongate shaft and may be used for the measurement of stomach pH, thus the sensor may be at or near the distal end of the elongate shaft. PH sensors such as those described in EP 2023881 may be particularly suitable for determining that the distal end of the elongate shaft (NG tube) of a pharyngeal stimulation catheter according to the present invention is located in the stomach. [0071] Catheters incorporating a pressure sensor for measurement of the high pressure zone in the upper esophagus sphincter of the patient or a pH sensor are particularly useful for treating chronic dysphagia. [0072] Ideally a pharyngeal stimulation catheter according to the present invention incorporates a position indicator and a sensor that provides diagnostic information to facilitate correct positioning of the electrodes. [0073] A further aspect of the invention includes a method of assisting recovery from dysphagia, comprising delivering an electrical stimulus to the body comprising sliding a sleeve over the elongate shaft of a catheter, said sleeve comprising one or more electrodes, fixing the sleeve to said elongate shaft once in position, and delivering an electrical stimulus to the body through said electrodes said electrical stimulus capable of inducing pharyngeal stimulation. [0074] As will be apparent to the skilled man, the method may include sliding the sleeve over the elongate shaft of the catheter, adjusting the position of the sleeve and/or elongate shaft, fixing the sleeve to the elongate shaft and then inserting the catheter into the body. The position of the sleeve and/or shaft may, optionally, be further adjusted prior to delivering an electrical stimulus to the body. [0075] Alternatively the sleeve is inserted into the body, followed by the elongate shaft, the position of the sleeve and/or shaft may, optionally, be adjusted after insertion. [0076] In a preferred embodiment of the invention there is provided a method of delivering an electrical stimulus to the body comprising sliding a sleeve over the elongate shaft of a catheter, said sleeve comprising one or more electrodes, clipping the sleeve to said elongate shaft once in position, inserting the device into the appropriate part of the body and delivering an electrical stimulus through said electrodes. [0077] The invention also provides a method of removing a slidable sleeve over a catheter, said sleeve comprising one or more electrodes and a means of fixing said sleeve to said catheter, comprising unclipping the clipping means and sliding said sleeve over said catheter whilst leaving said catheter in situ. [0078] Specific embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0079] FIG. 1 shows a single sleeve incorporating a connector, a clip and an electrical supply connector, pair of electrodes, wires, a Y-connector, a clip and an electrical supply connector. [0080] FIG. 2 shows a catheter comprising a sleeve as in FIG. 1 movably positioned over a nasogastric feeding tube. [0081] FIG. 3 shows a detail of the sleeve whereby a printed guide or window on the surface of the sleeve can be aligned with marks or guides on the surface of the core elongate structure on which the sleeve is positioned. [0082] FIGS. 4A and 4B show a catheter comprising a sleeve as in FIG. 1 movably positioned over an elongate tube containing sensors for the measurement of physiological status or function [0083] FIGS. 5 to 8 show various configurations of catheter comprising a reversible fixing means incorporated into a connector. [0084] FIG. 5 show a connector attached to the proximal end of the sleeve. The connector is in the form of a Y-connector that incorporates a reversible fixing means in the form of a collet that grips the elongate shaft (NG tube). [0085] FIG. 6 shows a Y-connector attached to the proximal end of the sleeve. The Y-connector incorporates a reversible fixing means in a wave form that grips the elongate shaft (NG tube). [0086] FIG. 7 shows a Y-connector attached to the proximal end of the sleeve. The Y-connector incorporates a reversible fixing means in the form of interference ribs that grip the elongate shaft (NG tube). [0087] FIG. 8 shows a Y-connector attached to the proximal end of the sleeve. The Y-connector incorporates a reversible fixing means in the form of a clamshell case that engages with a slidable compliant grommet mounted on the elongate shaft (NG tube). DETAILED DESCRIPTION [0088] A first particular preferred embodiment of the invention is for the delivery of electrical pharyngeal stimulation to the oropharyngeal region for the treatment of acute dysphagia in combination with the ability to safely deliver nutrition to the stomach. In this embodiment the core structure (elongate shaft) is a nasogastric (NG) feeding tube, typically 8Fr in diameter and 125 cm or more in length, formed of polyurethane, PVC or silicone, radio-opaque, surface printed at 1 cm distance intervals, terminating at the distal end in one or more feeding ports and at the proximal end with connectors suitable for engagement with an enteral feeding set. The sleeve is preferably a transparent flexible cover made of polyurethane or equivalent material, typically 14Fr in diameter and 35-45 cm in length, incorporating a pair of ring electrodes, wires connected to the electrodes for the delivery of electrical current and a Y-connector to guide the wires to a suitable electrical connector. In addition the invention comprises a clip for fixing the position of the sleeve relative to the NG tube and a means for sealing the gap between sleeve and NG tube at the proximal end of the sleeve. When not fixed in position via the clip the sleeve is capable of freely moving along the length of the core elongate structure. The clip or seal may form a part of the Y-connector assembly and therefore part of the sleeve or may be a feature independent of but connectable to the Y-connector. [0089] In this embodiment the connector at the proximal end of the NG tube may be capable of being disconnected to allow the sleeve to be completely removed by sliding over the proximal end of the NG tube before replacement of the NG connector. [0090] The connector could be configured for easy removal and reattachment to the NG tube in a number of ways including a reversibly engageable clip capable of gripping the NG tube, for example by virtue of ridges or equivalent on its inner surface. It could also operate in a similar fashion to a Touhy-Borst valve whereby NG connector contains a deformable O-ring which can be reversibly compressed through rotation of a screw fit portion and in this way hold or release the tubing which runs through the center of the O-ring. [0091] The sleeve is a flexible elongate tube generally formed from a plastic material such as polyurethane by a process of extrusion with distal ( 1 a ) and proximal 1 b ) ends and with a bore ( 2 ) extending along its length. The sleeve has a smooth or substantially circular outer surface ( 3 ) with at least one electrode, sensor or transducer disposed thereon. If the sleeve is used for the delivery of electrical stimulation, as in the embodiment illustrated in FIGS. 1 and 2 , generally there is at least one pair of electrodes ( 4 ) positioned on the surface of the sleeve at a location suitable for delivery of such stimulus to the patient. The electrodes are connected to two conducting elements ( 5 ) which are disposed laterally within the walls of elongate tube and emerge from the walls via small formed apertures into a Y-shaped junction ( 6 ) and from there via an insulated cover ( 7 ) to an electrical connector ( 8 ). The conducting elements are preferably constructed from multi-strand wire such as steel multi-strand wire. A connection between the electrodes and conducting element ( 5 ) is made by removing a section of the sleeve to form apertures exposing the underlying conductive element. The wire may then be bent back and a ring of conductive material applied using conductive adhesive, melting or welding. [0092] The sleeve has an aperture at both the distal ( 1 a ) and proximal ( 1 b ) ends in connection with the bore allowing the insertion of elongate shaft and the free movement of the sleeve along the length of the shaft. [0093] As shown in FIG. 3 the sleeve has one or more guides or windows printed or otherwise marked on its surface ( 16 ) to allow it to be positioned in a controlled way relative to the core elongated structure ( 17 ) and with reference to marks or guides ( 18 ) printed on the surface of the core elongate structure. [0094] The sleeve is compatible with the use of a clip ( 19 ), which reversibly fixes the sleeve to the core elongate structure once it has been adjusted to the correct position relative to that structure. The clip may be an integral part of the sleeve or may be a separate component. In addition to reversibly fixing the sleeve to the core structure the clip forms a seal to prevent ingress of liquids or particulate matter into the space between sleeve and core structure. [0095] A catheter according to the present invention, particularly such as that shown in FIG. 2 is useful in a method for the treatment of acute dysphagia, such a method is described in detail below and involves: Measuring the insertion distance for the core NG tube component by placing the distal end of the NG tube at the entrance to the patient nasal passageway, measuring the tube length to the earlobe and then to the xyphisternum. The total distance figure being noted on the printed guide on the NG tube surface. [0096] Disengaging the fixing clip on the sleeve if necessary and moving the sleeve along the surface of the NG tube until the appropriate window on the surface of the transparent sleeve is lined up over the previously noted insertion distance number. [0097] Engaging the fixing clip to prevent independent movement of the sleeve and introducing the catheter either orally or nasally but preferably nasally until the window over the correct insertion distance is just visible at the entrance to the patients' nasal passageways. [0098] Confirming that the distal end of the NG tube component is in the patient stomach is via standard methods namely X-ray or aspiration of stomach contents and testing of the pH. [0099] Delivering nutrition via the core NG tube by connecting to conventional enteral feeding apparatus. [0100] Delivering therapeutic electrical stimulation by connecting an appropriate device to the electrical supply connector on the sleeve and delivering the treatment via the electrodes in the sleeve. [0101] Disengaging the fixing clip and adjustment of the sleeve without removal of the whole catheter assembly from the patient if required. [0102] Disengaging the fixing clip and removal of the sleeve after the treatment regime is finished but without removal of the NG tube. [0103] Disengaging the fixing clip and adjustment of the sleeve without removal of the whole catheter assembly from the patient if required. [0104] Disengaging the fixing clip and removal of the sleeve after the treatment regime is finished but without removal of the NG tube. [0105] Disengaging the fixing clip and removing the NG tube without removing the sleeve from the patient if required and introduction of a new NG tube through the body of the sleeve until the correct insertion distance number is lined up with the window of the sleeve and engaging the fixing clip [0106] In the first embodiment shown in FIG. 2 a catheter is described which has the dual functions of therapeutic electrical stimulation to treat acute dysphagia and delivery of enteral nutrition. [0107] It comprises a core elongate structure in the form of a custom nasogastric (NG) feeding tube ( 9 ) onto which is disposed a sleeve capable of freely moving along the length of the NG tube. The sleeve is a substantially transparent flexible tube made of polyurethane, PVC, polyamide, silicone or equivalent material, typically 4.7 mm in outer diameter, with an internal lumen 3.3 mm diameter and 35-45 cm in length, incorporating a pair of ring electrodes, conducting elements disposed laterally along the walls of the tube connected to the electrodes and a Y-connector to guide the wires to an electrical connector. The internal surface of the sleeve may be modified with respect to its hardness, shape, finish or coating such that the modification helps to minimize friction when the sleeve is placed or moved along the NG tube on which it is positioned. The sleeve has visual position indicator in the form of a printed guide or window on its surface to facilitate it's positioning relative to the NG tube and is compatible with the use of a fixing clip to secure the sleeve to the NG tube when required. [0108] The NG tube is preferably 2.9 mm in diameter, with an internal lumen of 1.9 mm in diameter, 125 cm in length, formed of polyurethane, silicone or equivalent material with one or more ports ( 10 ) at its distal end ( 11 ) through which nutrients can be passed into the stomach. At its proximal end ( 12 ) there is a connector ( 13 ) compatible with connection to an enteral feeding set. This connector additionally has the capacity to be removed completely from the NG tube when required such that when removed the sleeve can be separated from the NG tube by sliding over the proximal end of the NG tube. The removable enteral connector can also then be replaced such that the device can continue to be used for enteral feeding purposes thereafter. The external surface of the NG tube may be modified with respect to its hardness, shape, finish or coating such that the modification helps to minimize friction between it and the surface of the internal lumen of the sleeve. The NG tube has a guide in centimeters displaying the distance from the distal end printed on its surface. The NG tube may also incorporate a guidewire ( 14 ) positioned within the internal lumen running from the proximal end of the NG tube to a position 1-3 cm from the distal end of the NG tube and fixed to a connector ( 15 ) compatible with the enteral connector. [0109] The use of the device will now be described with reference to FIGS. 1 and 2 . [0110] The distal end ( 11 ) of the NG tube is positioned adjacent to the external nostril of the patient. Whilst keeping the position of the end of the tube next to the nostril the tube is used to measure out the distance to the patients' earlobe and then to their xyphisternum. The total distance in centimeters from nostril to earlobe to xyphisternum (NEX) is obtained from the numerical printed guide on the surface of the NG tube. This represents the correct insertion distance for the NG tube ensuring that when the noted figure is visible at the entrance to the nostril sufficient tube has been inserted to allow the distal end to be within the stomach. [0111] The sleeve is positioned on the NG tube by insertion of the distal end ( 11 ) of the NG tube into the proximal end ( a ) of the sleeve and pushing it through the bore of the sleeve until it emerges from the distal end ( 1 b ) of the sleeve. The sleeve is moved along the surface of the NG tube until the printed window on the sleeve aligns with the insertion distance figure on the printed guide on the NG tube. The sleeve is fixed to the NG tube using the clip on the Y-connector. This ensures that when the combined device is inserted nasally into the patient and the printed window is visible at the entrance to the nostril, sufficient tube has been inserted both to allow the distal end of the NG tube to be within the stomach and to ensure that the electrodes on the sleeve are located within the stimulation target region in the oropharynx. The relative position of the sleeve on the NG tube may vary by 25 cm or more from patient to patient. [0112] The device is inserted nasally into the patient until the printed window on the sleeve is visible at the entrance to the nostril. The guidewire is removed and the section of the device external to the patient secured in position. The correct position of the distal end of the NG tube in the stomach is confirmed by pH testing of stomach aspirate or by X-ray. The enteral feeding connector ( 13 ) may be connected to an enteral feeding set to allow nutrient delivery. [0113] Therapeutic electrical stimulation is achieved by connecting an appropriate device to the electrical supply connector on the sleeve and delivering the treatment via the electrodes in the sleeve. In the event that adequate contact between electrodes and target tissues cannot be obtained the clip ( 19 ) securing the sleeve to the NG tube may be disengaged and small adjustments made to the vertical position of the sleeve before reengaging the clip. The patient will preferably receive 10 minutes of stimulation at 75% of the maximum tolerated current level at a frequency of 5 Hz and a pulse width of 2001JS for a period of 10 minutes once per day for three consecutive days. In the event that the NG tube becomes irredeemably blocked the clip may be disengaged and the NG tube removed completely whilst keeping the sleeve in place. A new NG tube may then be inserted until the NEX figure is lined up in the printed window of the sleeve and pH testing and X-ray carried out to confirm presence of the distal end in the stomach. [0114] Once the therapeutic electrical stimulation treatment regime is complete it may be desirable to remove the sleeve without removal of the NG tube. This is achieved as follows. [0115] The NEX number on the surface of the NG tube visible through the printed window of the sleeve is noted. The clip securing the sleeve to the NG tube is disengaged and, holding the sleeve to prevent its movement, additional NG tube is inserted through the sleeve into the patient until a figure equal to NEX+20 cm appears in the printed window of the sleeve. The clip is then reengaged. [0116] Both sleeve and NG tube are then slowly removed until the distal end of sleeve emerges from the nostril and the original NEX number is visible at the entrance to the nostril. This ensures that the distal end of the NG tube is still in the stomach. [0117] If the patient is in the process of receiving enteral feed, the pump is switched off and the enteral feeding connector disconnected from the enteral feeding set. The enteral feeding connector is then detached from the NG tube, the clip securing the sleeve to NG tube disengaged and the sleeve removed from the NG by sliding it over the proximal end of the NG tube. External parts of NG tube are wiped down with an appropriate disinfectant wipe. [0118] The enteral connector is re-attached to the proximal end of the NG tube and then to the enteral feeding set such that feeding can be re-started as required. [0119] In a second embodiment shown in FIGS. 4 a and 4 b the device has the dual functions of electrical pharyngeal stimulation and measurement. It comprises a core elongate structure ( 9 ) onto which is disposed a sleeve capable of freely moving along the length of the catheter. The sleeve is a substantially transparent flexible tube made of polyurethane, PVC, polyamide, silicone or equivalent material, typically 4.7 mm in outer diameter, with an internal lumen 3.3 mm diameter and 35-45 cm in length, incorporating a pair of ring electrodes, conducting elements disposed laterally along the walls of the tube connected to the electrodes and a Y-connector to guide the wires to an electrical connector. The internal surface of the sleeve may be modified with respect to its hardness, shape, finish or coating such that the modification helps to minimize friction when the sleeve is placed or moved along the catheter on which it is positioned. The sleeve has a printed guide or window on its surface to facilitate its positioning relative to the core elongate structure. More than one window may be printed on the surface to facilitate either nasal or oral insertion of the catheter. The sleeve is compatible with the use of a fixing clip to secure the sleeve to the core structure when required. [0120] The core elongate structure (shaft) can take a number of forms. In one embodiment ( FIG. 4 a ) it comprises a flexible tube typically 8 Fr in diameter ( 20 ) and 50-70 cm in length, in a region near to its distal end sensors or other means to measure pressure ( 21 ) particularly pressure exerted by the action of the upper esophageal sphincter, within the body of the tube wires to connect to the pressure sensing means ( 22 ) and at its proximal end an electrical connector ( 23 ) to a suitable means for capturing processing and displaying pressure data. [0121] FIG. 5 shows a sleeve ( 24 ) having a connector in the form of a Y-connector ( 25 ) that incorporates a reversible fixing means in the form of a collet that grips the elongate shaft (NG tube) ( 26 ) and also functions to guide the wires ( 27 ) to a suitable electrical connector ( 28 ). The proximal end of the sleeve ( 24 ) is bonded into the proximal end of the Y-connector ( 29 ) by gluing, welding, over molding or the like. The electrode wires ( 27 ) from the sleeve break out into a channel ( 30 ) in the connector to the electrical connector portion ( 28 ). An EEPROM device may be incorporated in the connector. The reversible fixing means comprises a two piece collet device ( 31 ) ( 32 ), comprising a first piece ( 31 ) that can be adjusted by the user to grip or release the NG tube thus permitting the user to easily adjust the sleeve position relative to the NG tube position. The electrical connector portion of the Y-connector may incorporate a sealing mechanism e.g. cap (not shown) for infection control purposes, the cap is used to seal the electrical connector when the electrical stimulation function is not in use. [0122] FIG. 6 shows a Y-connector attached to the proximal end of the sleeve ( 24 ). The Y-connector incorporates a reversible fixing means in the form of a casing ( 33 ) that incorporates a “wave form” ( 34 ) that grips the elongate shaft (NG tube). The position of the sleeve relative to the NG tube is adjusted by the user and fixed by the user inserting the NG tube into the wave form channel ( 34 ) and closing the casing (not shown). [0123] FIG. 7 shows a Y-connector ( 25 ) attached to the proximal end of the sleeve ( 24 ). The Y-connector incorporates a reversible fixing means in the form of casing ( 33 ) having interference ribs ( 35 ) that engage the elongate shaft (NG tube) ( 26 ), the interference ribs create a labyrinth that locks the NG tube in place. The user may easily adjust the sleeve position relative to the NG tube position and then fix the position by closing the lid ( 36 ) of the casing. [0124] FIG. 8 shows a Y-connector ( 25 ) attached to the proximal end of the sleeve ( 24 ). The Y-connector incorporates a reversible fixing means in the form of a clamshell case ( 37 ) that engages with a slidable compliant grommet ( 38 ) mounted on the elongate shaft (NG tube) ( 26 ). The grommet may be made of suitable materials such as deformable silicone or the like so that there is friction between the polyurethane NG tube and the grommet. [0125] The invention includes a method for the treatment of acute dysphagia, comprising; Measuring the insertion distance for the core NG tube component by placing the distal end of the NG tube at the entrance to the patient nasal passageway, measuring the tube length to the earlobe and then to the xyphisternum. The total distance figure being noted on the printed guide on the NG tube surface. Disengaging the fixing clip on the sleeve if necessary and moving the sleeve along the surface of the NG tube until the appropriate window on the surface of the transparent sleeve is lined up over the previously noted insertion distance number. Engaging the fixing clip to prevent independent movement of the sleeve and introducing the catheter either orally or nasally but preferably nasally until the window over the correct insertion distance is just visible at the entrance to the patients' nasal passageways. Confirming that the distal end of the NG tube component is in the patient stomach is via standard methods namely X-ray or aspiration of stomach contents and testing of the pH. Delivering nutrition via the core NG tube by connecting to conventional enteral feeding apparatus. Delivering therapeutic electrical stimulation by connecting an appropriate device to the electrical supply connector on the sleeve and delivering the treatment via the electrodes in the sleeve. Disengaging the fixing clip and adjustment of the sleeve without removal of the whole catheter assembly from the patient if required. Disengaging the fixing clip and removal of the sleeve after the treatment regime is finished but without removal of the NG tube. Disengaging the fixing clip and removing the NG tube without removing the sleeve from the patient if required and introduction of a new NG tube through the body of the sleeve until the correct insertion distance number is lined up with the window of the sleeve and engaging the fixing clip. [0133] The use of this embodiment of the device will now be described with reference to FIGS. 1 and 4A . [0134] The sleeve is positioned on the core elongate structure by insertion of the distal end ( 11 ) of the core structure into the proximal end ( 1 a ) of the sleeve and pushing it through the bore of the sleeve until it emerges from the distal end ( b ) of the sleeve. The sleeve is moved along the surface of the core structure until the printed window on the sleeve aligns either with a mark on the core structure corresponding to the average distance from the eternal entrance to the nostril to the center of the upper esophageal sphincter or a mark corresponding to the average distance from the incisors to the center of the upper esophageal sphincter, depending on whether the device is to be inserted nasally or orally. The sleeve is fixed to the core structure using the clip on the Y-connector. This ensures that when the combined device is inserted nasally or orally into the patient and the printed window is visible at the entrance to the nostril or incisors, sufficient tube has been inserted both to allow one or more of the pressure sensors located in distal region of the core structure to be close to or within the upper esophageal sphincter whilst at the same time ensuring that the electrodes on the sleeve are located within the stimulation target region in the oropharynx. [0135] The electrical connector on the proximal end of the core structure ( 23 ) is connected to a suitable means for analyzing and displaying pressure measurements from the pressure sensors in the distal region of the catheter. The combined sleeve and core structure are inserted either nasally or orally until the printed window is approximately 5 cm from the entrance to the nostril or incisors. The means for displaying pressure measurements is then monitored whilst continuing to insert the device. A characteristic change in the pressure readings indicates that the pressure sensors are within the upper esophageal sphincter and that the distal end of the core structure is located within the esophagus and not the upper airways. If required the device is further inserted until such time as the printed window on the surface of the sleeve is located at the entrance to the nostril or incisors as appropriate. The part of the device external to the patient is secured in position to prevent unwanted movement. [0136] Therapeutic electrical stimulation is achieved by connecting an appropriate device to the electrical supply connector on the sleeve and delivering the treatment via the electrodes in the sleeve. In the event that adequate contact between electrodes and target tissues cannot be obtained the clip ( 19 ) securing the sleeve to the core structure may be disengaged and small adjustments made to the vertical position of the sleeve before reengaging the clip. [0137] On completion of treatment the combined sleeve and core structure are removed slowly from the patient. The clip securing the sleeve to the core structure is disengaged and the sleeve removed by sliding it off the distal end of the catheter. Subsequent treatments to complete the treatment regime employ a new single use sterile sleeve each time. The core structure may be disposable or reusable. In the latter case the core structure is sterilized between treatments by standard methods known in the art. [0138] In the embodiment shown in FIG. 4B the core elongate structure comprises a flexible tube typically 8Fr in diameter ( 39 ) and 125 cm in length, in a region near to its distal end sensors or other means to measure pH ( 40 ) particularly low pH values consistent with the distal end of the elongate structure being positioned within the stomach, within the body of the tube wires to connect to the pH sensing means ( 41 ), a guide in centimeters displaying the distance from the distal end printed on its surface and at its proximal end a connector ( 42 ) to a suitable means for capturing, processing and displaying pH data. [0139] The use of this embodiment of the device will now be described with reference to FIGS. 1 and 4B . [0140] The distal end of the core structure is positioned adjacent to the external nostril of the patient. Whilst keeping the position of the end next to the nostril the core structure is used to measure out the distance to the patients' earlobe and then to their xyphisternum. The total distance in centimeters from nostril to earlobe to xyphisternum (NEX) is obtained from the numerical printed guide on the surface of the core structure. This represents the correct insertion distance for the core structure to ensure that when the noted figure is visible at the entrance to the nostril sufficient tube has been inserted to allow the distal end to be within the stomach. [0141] The sleeve is positioned on the core structure by insertion of the distal end of the core structure into the proximal end ( 1 a ) of the sleeve and pushing it through the bore of the sleeve until it emerges from the distal end ( 1 b ) of the sleeve. The sleeve is moved along the surface of the core structure until the appropriate printed window (depending on whether the catheter is to be inserted orally or nasally) on the sleeve aligns with the NEX number. The sleeve is fixed to the catheter using the clip on the Y-connector. This ensures that when the combined device is inserted nasally or orally into the patient and the printed window is visible at the entrance to the nostril or incisors, sufficient tube has been inserted both to ensure the distal end of the catheter will be in the patients' stomach whilst at the same time ensuring that the electrodes on the sleeve are located within the stimulation target region in the oropharynx. [0142] The combined sleeve and catheter are inserted either nasally or orally until the printed window positioned at the entrance to the nostril or incisors. The connector on the proximal end of the catheter ( 42 ) is connected to a suitable means for analyzing and displaying pH measurements from the pH sensors in the distal region of the catheter. A pH reading of 5.5 or less is indicative that the distal end of the core structure is located within the stomach and not the airways. The part of the device external to the patient is secured in position to prevent unwanted movement. [0143] Therapeutic electrical stimulation is achieved by connecting an appropriate device to the electrical supply connector on the sleeve and delivering the treatment via the electrodes in the sleeve. In the event that adequate contact between electrodes and target tissues cannot be obtained the clip ( 43 ) securing the sleeve to the core structure may be disengaged and small adjustments made to the vertical position of the sleeve before reengaging the clip, [0144] On completion of treatment the combined sleeve and core structure are removed slowly from the patient. The clip securing the sleeve to the catheter is disengaged and the sleeve removed by sliding it off the distal end of the core structure. Subsequent treatments to complete the treatment regime employ a new single use sterile sleeve each time. The core structure may be disposable or reusable. In the latter case the core structure is sterilized between treatments by standard methods known in the art.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention pertains in general to fishing lures and in particular to fishing lures of the type which emit a sound which attracts fish to the lure which are then caught by the fish attempting to swallow the lure. 2. Description of the Prior Art A fish is a red-blooded, gill-breathing aquatic animal, which is believed to be the oldest of the vertebrates. The majority of fresh water and marine fish belong to the ray-fin group, the Teleost, which range from the more primitive herring and their relatives to the highly-developed perch and their allies. It is generally accepted that fish are able to detect or "hear" as well as generate or produce sounds and other mechanical disturbances within their water environment. Most fish have a sensitive lateral line on each side of their body that responds to pressure waves in the water. In some of the fish the air float or air bladder is a supplementary respiratory organ and in others it aids in hearing and may also be used to produce sounds by acting as a vibrator and resonator. The sensory mechanism by which fish detect mechanical disturbances and the functional relationship of the sensitive lateral line and the internal auditory apparatus will be briefly reviewed. Fish do not hear sound but rather feel vibrations which are transmitted through the water to the sensitive lateral lines on the sides of their body. Mechanical vibrations or sounds cause the entire fish to vibrate. The vibrations are transmitted through the sensitive lateral lines of the fish into an inner ear mechanism. As is the case with all vertebrates, the receptor element in the ear of the fish are hair cells which are connected to cranial nerves. The sensory hair cells in fish are all of the cylindrical form. Very similar cells are present in the equilibratory portion of the ear and in a lateral line where they detect mechanical disturbances such as the small wave made by an insect that has fallen into the water. In each case nerve impulses are triggered by bending of the hairs. In the auditory part of the ear the hairs are imbedded in the tiny gelatinous mass that contains loosely-suspended tiny stones (otolith), while the body of the hair cell is part of the wall of the otolith chamber. When wave sounds impact on a fish, they cause minute vibrations of the whole animal and with it the otolith chamber wall. Since the otolith is floating, however, it moves slowly and with less amplitude than the initiating vibrations. This results in a shearing action on the hairs and thereby generates nerve impulses which are felt by the fish. Most fish do not have any amplifying structure comparable to the ear drum and the middle ear ossicles of mammals. However, in nearly one-third of the fish, the air bladder acts as a drum which, as mentioned above, aids in a fish's hearing and may be used to produce sounds by acting as a vibrator and a resonator. Most fish of the Teleost species are predators in the sense that they survive by eating other living animals which, most often, are small fish. The auditory capabilities of such fish is very beneficial to their life cycle, in that they can hear the sounds of struggling, frenzied or feeding fish upon which they prey. Such sounds are particularly attractive to predator fish which include but are not limited to grouper, snapper, trout, dolphin, bluefish, and other like fishes which are considered good eating by humans. It is also known that members of the Elasmo group which include other predators such as sharks, are also attracted by the struggling or feeding sounds of other fish. Moreover, recent studies have shown that the auditory mechanism of predator fish are particularly sensitive to low frequency sounds between the range of fifty-to-three hundred (50 to 300) Hertz and that the sounds produced by struggling frenzied or feeding fish are within this frequency range The present invention, in accordance with the above, utilizes the sensitivity of fish to low frequency sounds by attracting such fish having the capability to "hear" these sounds. The fish are caught with lures which produce the low frequency sounds which imitate the frenzied sounds of fish in distress or fish feeding. In the prior art a number of United States patents have utilized sounds produced by various means in order to attract fish to the lure and thereby aid in catching the same. Typical of these United States patents are: "Audible Fish Lure," U.S. Pat. No. 2,577,229; "Sound Producing Fish and Game Lure," U.S. Pat. No. 2,757,475; "Sound Producing Fish Lure," U.S. Pat. No. 2,784,399; "Fish Lure," U.S. Pat. No. 2,932,110; "Fish Lure," U.S. Pat. No. 3,120,073; "Sonic Fishing Lure," U.S. Pat. No. 3,416,254; and "Vibrating Fish Lure," U.S. Pat. No. 4,223,467. While all of these patents disclose fishing lures which emit sounds, they are typically deficient in that they fail to achieve a sonic fishing lure which combines all of the necessary elements of a successful fishing lure. For example, it is necessary that the lure be of a sufficiently small size to allow catching fish in the range of approximately five-to-ten pounds which is the range of most members of the Teleost species. Further, it is necessary to produce a sound of sufficient magnitude to attract such fish from relatively large distances. Then too, a successful sonic fishing lure produces sound in a frequency range which is attractive to fish. A further deficiency apparent in the prior art is the inability of the prior art fishing lures to produce a sufficiently loud sound and yet not consume an inordinate amount of energy so that the lure may be used for relatively long periods of time without the need to replace the energy source. Accordingly, a primary object of the present invention is to provide a sonic fishing lure which is small in size but yet produces a sound which is attractive to fish at a reasonably loud level so as to travel in water over relatively large distances and yet consume a relatively small amount of energy so as to have a relatively long operating lifetime. Another object of the present invention is to provide a sonic fishing lure which produces reasonably loud sound at the relatively low frequency range of between fifty and three hundred (50 and 300) Hertz. Another object of the present invention is to provide new and improved vibration means for producing an intensified level of sound within the body of a fishing lure in order to produce an external sound having a sufficient intensity to travel over relatively long distances. Yet another object of the present invention is to provide new and improved means for efficiently transmitting sounds produced internal of a fishing lure, through the walls thereof and into the water surrounding the same. A still further object of the present invention is to provide a sonic fishing lure which may be used at great water depths, at the surface of the water, or at any location therebetween so as to attract any of the various types of predator fish which normally inhabit the water at the various levels. The above-stated objects as well as other implied objects, are accomplished by the present invention and will become apparent from the hereinafter set forth Summary of the Invention, Detailed Description of the Invention, Drawings, and the claims appended herewith. SUMMARY OF THE INVENTION The above-stated objects as well as other objects which although not specifically stated, but are intended to be included within the scope of the present invention, are accomplished by the present invention which comprises a fishing lure of the sonic variety which produces a sound at a frequency level which is attractive to a large majority of the edible and sporting predator fish of the Teleost and Elasmo species. An electronic circuit is provided within the body of a fishing lure which includes a DC voltage source and a first astable multivibrator which produces an output signal of approximately one (1) Hertz. This output is sent to another astable multivibrator which outputs a pulsed signal of approximately one hundred (100) Hertz. The multivibrator circuit parameters are selected such that the output signal grouping of approximately one hundred (100) Hertz is pulsed with approximately a 200 millisecond interval between each output signal grouping. The pulsed output of the electronic circuit is input into an improved sonic transducer which comprises coil activated vibrating plates. The level of the sound output from the improved sound transducer achieves high volumes due to a pair of vibrating plates which are joined together by a flexible axial rod between the plates. The plate portion of the sound transducer is located within a fluid filled chamber contained within one end of the body of the fishing lure. Thus, in the invention the sound from the sonic transducer is coupled to the body of the fishing lure by the fluid interposed therebetween and in contact therewith. The sound produced is then transmitted into the water, within which the fishing lure is located, by the direct coupling of the water external to and in contact with the body of the fishing lure. In the manner provided, the power required or consumed to produce sound of sufficient intensity is held to a minimum due to the emission of sound from the sonic transducer to the water surrounding the lure being accomplished at a high rate of efficiency. Standard fishing hooks may be attached to various points or locations on the outside of the body of the fishing lure in a normal manner. Also, the front of the fishing lure is provided with an eyelet to allow the attachment of a fishing line thereto. Various other objects, advantages and features of the invention will become apparent to those skilled in the art from the following discussion taken in conjunction with the following drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an overall isometric view of the sonic fishing lure as provided by the present invention; FIG. 2 is a plan view of an axial cross-section through the fishing lure of FIG. 1; FIG. 3 is cross-sectional plan view of the sonic transducer as provided by the present invention; FIG. 4 is a schematic block diagram of the electronic circuitry of the fishing lure of FIG. 1; and, FIG. 5 is a typical schematic curve illustrating the pulse sonic output of the electronic circuitry of FIG. 4. DESCRIPTION OF THE PREFERRED EMBODIMENTS As required, detailed embodiments of the present 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 structural and functional 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. Reference is now made to the drawings wherein like characteristics and features of the present invention shown in the various figures are designated by the same reference numerals. FIG. 1 depicts a perspective view of the inventive sonic fishing lure 10 which includes a main body portion 11, a nose portion 12, and a tail portion 13. The overall shape of the sonic fishing lure 10 is not necessarily critical to the operation of the invention and may, therefore, comprise any of the well-known shapes that a conventional deep-water, mid-water, or surface-water fishing lure has in the past assumed. However, the overall shape depicted in FIG. 1 is that of a tested and proven streamlined configuration which easily cuts through water and because of its downward extending head portion maintains a substantially constant level within the water. It is important that the outside shell of the sonic fishing lure 10 be hermetically sealed so as to protect the internal components thereof from the adverse effects of the water environment within which the sonic fishing lure 10 is used. Typical fishing hooks 14 may be connected to any convenient location on the body of the sonic fishing lure 10. In the illustrated example one fishing hook is placed at eye 19 at the tail portion 13 while a second fishing hook is placed at eye 19 at the mid-bottom portion of the center portion 11 of sonic fishing lure 10. Similarly, the fishing line 15 may be appropriately connected to the eye 19 at the front or nose piece 12 of the sonic fishing lure 10. FIG. 2 is a cross-sectional plan view of the inventive sonic fishing lure 10 illustrating one arrangement of the layout of the internal components. The main body 11 of the inventive sonic fishing lure 10 may be considered to comprise three parts, the mid-body portion 16, the front body portion 17 and the back body portion 18. Each portion is, of course, contiguous with the other portions and together form a generally one-piece main body 11. A first wall 24 separating back portion 18 from midportion 16 together with a hollow tail cap 38 forms a battery chamber 25. As illustrated in FIG. 2 of the drawings, cap 38 is threadingly connected 31 to back body portion 18. A seal such as an O-ring seal 32 is used to seal the connection between cap 38 and back body portion 18. In this manner battery chamber 25 comprises a water-proof hollow chamber. Within chamber 25, are located three series connected DC batteries 20 of, for example, 1.5 volts each which together yield a total output of 4.5 volts. Each battery 20 may typically comprise a hearing aid battery, such as a type 675, for sonic fishing lures having an overall size of approximately two-to-four inches. For larger larger sonic fishing lures, a greater number of larger and more powerful batteries may be utilized. The negative connection 21 of the series connected batteries 20 may be accomplished in any conventional manner such as by a metallic spring imbedded in a bored out top portion of cap 38 and by which when cap 38 is screwed into sealing contact with back body portion 18, an electrical contact is made with the negative end of the stack of batteries 20. Similarly, a positive electrical connection 34 may be made by a protruding contact imbedded within wall 24 which wall is located between front 17 and mid 16 body portions of fishing lure 10. Electrical wires 22 and 23 connect the positive and negative connections 34 and 21 to batteries 20 with the electrical circuitry of the sonic fishing lure 10 at connections 28 and 29 within an electrical circuit chamber 26. Wires 22 and 23 may be imbedded, respectively, within cap 38 and mid-body portion 16 during the process of manufacturing the respective components. Or, may comprise insulated wires passing through an opening in wall 24. Such technology is well known and need not be repeated within this specification. Within the electrical circuit chamber 26, which is also a sealed air-tight chamber, is located an electronic circuit mounting board 27. Circuit board 27 may comprise a PC board to which is mounted the various electronic components of the circuitry as more fully explained hereinafter. The output of the electric circuit is input into a sonic transducer 30 which outputs the sound which is attractive to fish. Sonic transducer 30 is mounted, in the example shown, within a wall 33 connecting the front body portion 18 to the mid-body portion 16 of the sonic fishing lure 10. A seal 35 surrounds the cylindrical body of sonic transducer 30 so as to form a fluid tight seal between a sonic chamber 36 and the mid-body body or electrical circuit chamber 26. Seal 35 may simultaneously fit within grooves in the cylindrical body of sonic transducer 30 and in a circular cutout within wall 33 to form a good seal and aid in maintaining the fixed position of transducer 30. Connections 37 and 38 of sonic transducer 30 may be used to connect the output signal from the electric circuit of the sonic fishing lure 10 to sonic transducer 30. Sonic chamber 34 is completely filled with a fluid such as distilled water and is, therefore, in fluid contact with the exterior surface of sonic transducer 30 and the interior surface of sonic chamber 34. The sound output from sonic transducer 30 is, therefore, fluid coupled between sonic transducer 30 and the fluid within chamber 34 and also fluid coupled to the walls of chamber 34 by the fluid contained therin. This fluid coupling provides for an efficient transmittal of sound from the interior of sonic fishing lure 10 to the water surrounding the same by another fluid coupling comprising the contact of the water within which the sonic fishing lure 10 is to be used and the outer skin of primarily the tail portion 18 of sonic fishing lure 10. Sonic transducer 30 is shown in cross section in FIG. 3 of the drawings. Sonic transducer 30 may be of a type comprising a vibrating plate which is activated by an electrical coil. Accordingly, sonic transducer 30 may, for example, comprise a QMB-111 series transducer manufactured by Star Incorporated, but as modified as hereinafter described. An axial shaft 40 is fixedly connected to and perpendicular with the center portion of the disk 41 within sonic transducer 30. The other end of rod or shaft 40 is fixedly connected to a second disk 42 in a manner similar to the connection to disk 41. The effect of combination of disks 41 and 42 as coupled by and separated by shaft or rod 40 is to increase significantly (approximately three times more) the sound output from a standard sonic transducer. Cap 43 is used to cover disk 42 and is sealingly connected to cap 44. Disk 42 may comprise a vibrating mass having a diameter of approximately three-quarters of the size of the diameter of disk 41 but a thickness of more than twice that of disk 41. The length of rod 40 may approximately be equal to the diameter of disk 42. Cap 43 is addition to providing a waterproof connection to the main body of sonic transducer 30 also acts as a sonic resonant chamber. Disk 42 and shaft 40 may be made from a material such as ordinary carbon steel having a diameter of 12 millimeters and a thickness of 1.5 millimeters, while shaft 40 may be made from piano wire having a thickness of 2 millimeters and a length of 7 millimeters. The flexibility of shaft 40 allows disk 42 to hit the sides of cap 43 to further increase the sound output from transducer 30. Test measurements have verified that a sonic transducer of the type disclosed and described herein results in an increase of the standard output of a QMB-111 transducer from eighty (80) decibels at ten (10) centimeters to over two hundred (200) decibels at ten (10) centimeters in the air. Underwater tests have verified the increased output of the modified sonic transducer 30 as well as the effectiveness of the sonic coupling aspects of the inventive fishing lure 10. The electrical circuitry of the sonic fishing lure 10 is shown schematically in block fashion in FIG. 4 of the drawings. An electrical source comprising batteries 20 are connected to a first astable multivibrator 47 the output of which is connected to a second astable multivibrator 48 whose output in turn is connected to sonic transducer 30. Astable multivibrator 47 outputs a signal of approximately one (1) Hertz while a second astable multivibrator 48 outputs a signal of approximately one hundred (100) Hertz. The output signal of vibrator 48 and, therefore, the output signal of sonic transducer 30 are pulsed as shown in FIG. 5 of the drawings. It has been determined that intermittently pulsed outputs at approximately one hundred (100) Hertz which lasts for a duration of approximately 700 milliseconds and separated by a non-sound producing time of approximately 200 millisecond has been more effective to attract fish as compared to a continuous signal. The pulsed sonic output is, of course, constantly repeated while the inventive fishing lure is being used within a body of water to attract and catch fish. The pulsed sound output by the inventive fishing lure 10 is able to be distinguished by fish over the ever present normal background noise within bodies of water. Furthermore, the pulsed output tends to simulate sounds output by a fish in distress which also outputs an intermittent sound. In this manner the inventive fishing lure appears to be a fish in distress to the fish within the vicinity of the sonic fishing lure 10. In accordance with the features provided by the inventive sonic fishing lure 10 to efficiently maximize the sound output by the sonic fishing lure 10, a highly effective fishing lure is presented. A fluidic coupling of chamber 34 in combination with the vibrating mass of the improved sonic transducer 30 together output a relatively intense sound which travels over relatively large distances. While the invention has been described, disclosed, illustrated and shown in certain terms or certain embodiments or modifications which is has assumed in practice, the scope of the invention is not intended to be nor should it be deemed to be limited thereby and such other modifications or embodiments as may be suggested by the teachings herein are particularly reserved especially as they fall within the breadth and scope of the claims here appended

1a

CROSS REFERENCE TO RELATED APPLICATION The present application is a continuation-in-part of U.S. application Ser. No. 5,585, filed Jan. 22, 1979. FIELD OF THE INVENTION The present invention relates to a process for preparing interferon, particularly Type II interferon, and to a process for preparing therapeutic and prophylactic agents thereof which are effective for Type II interferon-sensitive diseases. BACKGROUND OF THE INVENTION As described by Shigeyasu Kobayashi, "Interferon", published by Kodansha Co. Ltd., Tokyo, Japan (1975), D. A. J. Tyrrell, "Interferon and Its Clinical Potential", published by William Heineman Medical Books Ltd. (London) (1976), and in "Protein, Nucleic Acid and Enzyme", vol. 21, no. 4 (1976), interferon is the term designated for a proteinaceous substance which is intra- or extra-cellularly induced by exposing living cells to the action of an interferon inducer, for example virus, bacterium, protozoon, rickettsia, nucleic acid, endotoxin and polysaccharide, and which has a function to inhibit non-specifically the multiplicaton of various virus in cells. Because of its viral multiplication inhibitory function, interferon has been long considered as a promising therapeutic and prophylactic agent for viral diseases since its discovery. Recently, it has been demonstrated that interferon acts as an anti-tumor agent not only on viral tumor but also on non-viral tumor, and therefore, the realization of interferon as a medicine has been in great expectation. It is well documented that the term interferon involves Type I and Type II interferons; the former, Type I interferon or classical interferon with a molecular weight of about 1-3×10 4 , which is induced by exposing living cells to viral infections, and the latter, Type II interferon or immune interferon with a molecular weight of about 4-7×10 4 , which is induced in lymphocytes on stimulation with mitogens or on response to antigens. As described by L. B. Epstein, "Texas Reports on Biology and Medicine", vol. 35, pp. 41-56 (1977), published at the University of Texas Medical Branch, Galveston, Tex., U.S.A., Type II interferon is less stable than Type I interferon under vigorous conditions; at a pH below 2 and above 10, and/or at a temperature above 56° C. Since Type II interferon, however, has a close relationship to immunoreactions, Type II interferon is expected to have much higher therapeutic and prophylactic efficacies on interferon-sensitive diseases than Type I interferon. Due to its high species-specificity, the therapeutic and prophylactic efficacies on human diseases are not realizable with interferon which is obtained from other sources than living human cells. So far leukocytes are used in the preparation of Type II interferon. An attainment of a large amount of Type II interferon at a low cost from leukocytes is quite difficult because leukocytes must be separated and prepared from fresh blood, and do not bear long-period storages. Due to the circumstances, commercial production of Type II interferon feasible as a therapeutic and prophylactic agent for human diseases has not been realized. SUMMARY OF THE INVENTION The present inventors investigated processes which could be easily applied for commercial-scale production of Type II interferon and studied the possibilities of said interferon as a therapeutic and prophylactic agent. The efforts resulted in the discovery that a large amount of high-titred Type II interferon was not obtainable by transplanting and multiplying Type II interferon-producing established human cells in a nutrient culture medium in vitro, but was easily obtainable by transplanting the cells in other warm-blooded animal body or inoculating the cells in a culture medium charged in a filter-membrane-interposed diffusion chamber which is designed and fitted in or to the animal body so that the cells can grow on its nutrient body fluid, multiplying the transplanted or inoculated cells utilizing said body fluid in the warm-blooded animal body or the diffusion chamber, then exposing the multiplied cells to the action of a Type II interferon induced in vivo or in vitro to induce Type II interferon, and purifying and separating the induced Type II interferon, and that the Type II interferon obtained by the method disclosed herein was an excellent therapeutic and prophylactic agent for Type II interferon-sensitive diseases. The process according to the present invention differs from conventional processes wherein the living cells are multiplied in vitro, and has the advantages that it requires no or much less nutrient medium supplemented with expensive serum, that the maintenance and control of the conditions during the multiplication of established human cells are easier, and that a higher-titred Type II interferon is easily obtainable. In the process according to the invention, established human cells can be easily multiplied in another warm-blooded animal body utilizing the body fluid by either transplanting the cells therein, or connecting in or to the animal body a diffusion chamber charged with a culture medium suspended with said cells, while feeding the animal in the usual way. Particularly, as compared with conventional processes wherein the cells are multiplied in vitro, the process according to the invention has additional features that the multiplication of the cells is steadier, that the multiplication rate is higher, and that the yield of induced Type II interferon per cell is much higher. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Any established human cells can be used as far as they multiply readily when transplanted in other warm-blooded animal body; for example HPB-ALL cell, MOLT-3 cell, P 12/Ichikawa cell, HPB-MLT cell, P 8/Seki cell, JBL cell, HCL cell and P 10/Shibata cell, described in, "Protein, Nucleic Acid and Enzyme", vol. 23, no. 6, pp. 697-711 (1978), Namalva cell described in "Journal of Clinical Microbiology", vol. 1, pp. 116-117 (1975), and BALL-1 cell, TALL-1 cell and NALL-1 cell described by I. Miyoshi, "Nature", vol. 267, pp. 843-844 (1977). Particularly, the human lymphoblastoid cell lines are preferable. Established human cells usable in the present invention may be chosen from the above cells, although not limited to them. In steps prior to Type II interferon induction, the above cells can be used alone or in combination. To these cells, if desired, are mixed human leukocytes prepared from fresh human blood. Any warm-blooded animal can be used in the present invention as far as established human cells can multiply therein: for example birds such as chicken and pigeon; and mammalians such as dog, cat, monkey, goat, pig, bovine, horse, rabbit, guinea pig, rat, hamster, mouse and nude mouse. Since transplantation of human cells in the above-mentioned animal bodies tends to cause undesirable immuno-reactions, animals in the most immature state, namely, egg, fetus, embryo, or new-born or infant animal, should be chosen to depress the immunoreactions as much as possible. Prior to transplantation of the cells, the animal may be irradiated with about 200-600 REM of X-ray, or γ-ray, or by injecting antiserum or an immunosuppressive agent, to depress the immunoreactions. Nude mouse, even adult, is preferable as a warm-blooded animal because it is less liable to cause undesirable immunoreactions and established human cells can be transplanted thereto and multiplied rapidly without any pre-treatment. Transplantation of multiplied human cells from one warm-blooded animal body to another warm-blooded animal body can make multiplication of the cells much steadier and the amount of Type II interferon that induced in the cells much larger; for example, established human cells are transplanted in hamsters and multiplied therein, and then the multiplied human cells are harvested and transplanted in nude mice. In this case, the multiplied cells can be transplanted further from one warm-blooded animal body to another warm-blooded animal body of the same species, genus, class or division. Established human cells can be also transplanted to any part of the animal body so far as they multiply easily therein; for example intraperitoneally, intravenously, subcutaneously or in allantoic cavity. Instead of transplanting and multiplying established human cells in other warm-blooded animal body, any above-mentioned cells can be inoculated and multiplied in a nutrient of other warm-blooded animal body in a conventional-type diffusion chamber which is embedded, for example intraperitoneally, and devised to allow the cells to utilize said body fluid. The chambers which are usable in the invention can be of various shapes and sizes, and should be interposed with filter membranes, for example membrane filter, ultrafilter and hollow fiber, to prevent leakage of cells. Particularly, chambers with interposed filter membranes with pore sizes of about 10 -7 to 10 -5 m are preferable. If necessary, the diffusion chamber can be designed and placed, for example on the surface of the animal body, so that the nutrient body fluid of the animal can circulate through the chamber and the development of the established human cells inoculated in said chamber can be observed through a transparent side window made in the chamber wall. The diffusion chamber can be also designed and devised so that it can be disconnected periodically from the animal body and the cells multiply through the whole life of the animal without any unnecessary sacrifice of the animal to increase further the yield of the multiplied cells per animal. Furthermore, the process using the above-mentioned diffusion chamber has an additional feature, besides the multiplied human cells can be easily harvested because there is no direct contact of the cell with the animal cell, that various warm-blooded animals can be used without any pretreatment to depress their immunoreactions because of their lower possibilities of causing the immunoreactions. The process of the present invention offers the convenience that the animal to which established human cells are transplanted can be fed in the usual way and that no special treatment is required even after transplantation of cells. The period required for sufficient multiplication of the transplanted established human cells is usually about 1 to 10 weeks. The number of the multiplied human cells was counted and found to be about 10 7 to 10 12 or more per animal. In other words, the process according to the invention is extremely advantageous for preparing Type II interferon because the number of the cells transplanted or inoculated in or to the animal body or the diffusion chamber increases about 10 2 to 10 7 folds or more by said process; about 10 to 10 6 folds more than those attained by inoculating and multiplying the same cells in nutrient culture medium in vitro. As to the induction of Type II interferon, any method can be employed as far as it induces Type II interferon in the multiplied living human cells. The cells can be exposed to the action of a Type II interferon inducer wherein they multiplied. For example, the human cells multiplied in ascites in suspension or the tumor cells that occurred subcutaneously can be exposed to the action of a Type II interferon inducer in vivo wherein they multiplied, and the induced Type II interferon is then purified and separated from the ascites or the tumor. In contrast, the multiplied human cells can be exposed after the isolation to the action of a Type II interferon inducer in vitro to induce Type II interferon. For example, the multiplied human cells harvested from ascites, or those isolated and dissociated from the massive tumors that occurred subcutaneously are suspended in a nutrient medium kept at about 20° to 40° C., to give a cell concentration of about 10 5 to 10 8 cells per ml, and then exposed to a Type II interferon inducer. Then, the induced Type II interferon is purified and separated. When human cells are multiplied in a diffusion chamber, the cells can be exposed to a Type II interferon inducer in said chamber in vivo, or exposed to the inducer in vitro after recovering them from said chamber. In the production of Type II interferon, if desired, the amount of the induced Type II interferon can be augmented further by known methods such as the priming method using highly human species-specific interferon and/or the super-induction method using a metabolic inhibitor. Furthermore, the yield of the induced Type II interferon per animal can be augmented further by one or more of the following methods: (1) a method in which the multiplied cells are first exposed to a Type II interferon inducer to induce said interferon wherein they multiplied, and then exposed after harvesting from a certain or a whole part of the animal body to a Type II interferon inducer to induce said interferon in vitro. (2) a method in which the human cells that were already used or used repeatedly in the production of Type II inerferon are exposed to the action of a Type II interferon inducer in vivo or in vitro to induce said interferon, and (3) a method in which a diffusion chamber embedded or connected in or to the animal body is disconnected periodically to augment the number of the multiplied human cells. As to Type II interferon inducer, usually mitogens such as phytohemagglutinin, concanavalin A, pork weed mitogen, lipopolysaccharide, polysaccharide, endotoxin and bacterium are preferable. For sensitized cells, antigen also acts as a Type II interferon inducer. The above-mentioned Type II interferon inducers are used usually in a concentration of about 0.001 μg to 10 mg per ml. In addition, the employment of one or more Type I interferon inducers, for example virus, nucleic acid and polynucleotide, in combination with a Type II interferon inducer augments further the yield of the induced Type II interferon, and also enables simultaneous induction of Type I and Type II interferons. The induced Type II interferon can be purified and separated easily by conventional purification and separation techniques, for example salting out, dialysis, filtration, centrifugation, concentration and freeze-drying. If higher purified Type II interferon preparation is desirable, Type II interferon of the highest purity is obtainable by employing conventional techniques, for example adsorption and desorption by ion exchanger, gel filtration, affinity-chromatography, isoelectric point fractionation and electrophoresis, in combination with the above-mentioned techniques. The activities of higher human species-specific Type I and Type II interferons were determined by the conventional plaque reduction method with human amnion cells which are described in "Protein, Nucleic Acid and Enzyme", vol. 20, no. 6, pp. 616-643 (1975), published by Kyoritsu Shuppan Co. Ltd., Tokyo, Japan. The hemagglutination unit was assayed according to the method reported by J. E. Salk, "Journal of Immunology", vol. 49, pp. 87-98 (1944). EXPERIMENT A below describes the production of Type II interferon according to the invention. EXPERIMENT A Interferon-productivity of the cells multiplied in vitro or in vivo EXPERIMENT A-1 Multiplication in vitro BALL-1 cells were inoculated in RPMI-1640 medium supplemented with 20% of fetal bovine serum at pH 7.2 and were cultured in suspension at 37° C. The multiplied cells were washed with serum-free RPMI-1640 medium at pH 7.2 and suspended in a fresh medium of the same composition to give a cell concentration of about 1×10 6 cells per ml. EXPERIMENT A-2 Multiplication in vivo New-born hamsters were pre-injected with antiserum prepared from rabbit according to the known method to depress their immunoreactions, and then were transplanted subcutaneously with BALL-1 cells. The hamsters were fed in the usual way for 3 weeks. The massive tumors that occurred subcutaneously were isolated, cut finely and dissociated in a physiological saline solution containing trypsin to collect the multiplied cells. The cells thus obtained were washed with serum-free RPMI-1640 medium at pH 7.2 and suspended in a fresh medium of the same composition to give a cell concentration of about 1×10 6 cells per ml. EXPERIMENT A-3 Production of interferon The suspensions of BALL-1 cells obtained in EXPERIMENT A-1 and A-2, a cell concentration of about 1×10 6 cells per ml, were exposed to phytohemagglutinin and/or Sendai virus to induce interferon. More particularly, when phytohemagglutinin was used alone, the suspensions were added with phytohemagglutinin in a proportion of about 100 μg per ml and incubated at 37° C. for 3 days to induce interferon. When Sendai virus was used alone, the suspensions were added with the virus in a proportion of about 300 hemagglutination units per ml and incubated at 37° C. for day to induce interferon. When both phytohemagglutinin and Sendai virus were used in combination, the suspensions were first added with phytohemagglutinin in a proportion of about 100 μg per ml, incubated at 37° C. for 2 days, then added with Sendai virus in a proportion of about 300 hemagglutination units per ml, and incubated at 37° C. for an additional day to induce interferon. The interferon-containing suspensions thus obtained were centrifuged. The resulting supernatants were concentrated with an ultrafilter having a cut-off molecular weight of 6,000 and then fractionated according to the molecular weight with dextran gel. The activities of the obtained Type I interferon, molecular weight of about 25,000, and Type II interferon, molecular weight of 50,000, were determined to evaluate the interferon activities per ml suspension upon incubation. The results are shown in Table 1. TABLE 1______________________________________ MultiplicationInterferon inducer in vitro in vivo______________________________________Phytohemagglutinin 20 400 (20) (400)Sendai virus 1,700 6,700 (0) (0)Phytohemagglutinin 1,740 24,000 + Sendai virus (30) (11,000)______________________________________ Note: The determined total interferon activities upon incubation are expressed by units per ml suspension, and those of Type II interferon for each preparation are shown in parenthesis. As obvious from the results shown in Table 1, while a small amount of interferon was induced in cells multiplied in vitro, a large amount of interferon was induced in cells multiplied in vivo. The cells multiplied in vitro as well as in vivo, produced Type I interferon when they were exposed to Sendai virus. The cells multiplied in vivo, however, gave 4 times higher activity than those multiplied in vitro. In respect to the interferon activities of the preparations induced by phytohemagglutinin and/or Sendai virus, a remarkable synergism attributed to the interferon inducers was noted in the production of Type I and Type II interferons when the cells multiplied in vivo were used. Particularly, Type II interferon induced by using phytohemagglutinin and Sendai virus in combination had an about 28 times higher activity than that induced by using phytohemagglutinin alone. No synergism was, however, observed when the cells multiplied in vitro were used. Several embodiments illustrating the production of Type II interferon according to the present invention are shown below. EXAMPLE A Production of Type II interferon Example A-1 Adult nude mice were transplanted subcutaneously with established human BALL-1 cells and were fed in the usual way for 3 weeks. The massive tumors that occurred subcutaneously, about 10 g per nude mouse, were isolated, cut finely and dissociated in a physiological saline solution containing trypsin to collect the multiplied human cells. The cells were washed with an Eagle's minimal essential medium supplemented with 5 v/v % human serum at pH 7.2, and suspended in a fresh medium of the same composition to give a cell concentration of about 5×10 6 cells per ml at 37° C. To this suspension was added a partially-purified high human species-specific interferon in a proportion of about 100 units per ml, and the mixture was incubated for about 2 hours. Phytohemagglutinin was then added to the mixture in a proportion of about 200 μg per ml. Then, the mixture was incubated at this temperature for an additional 3 days to induce Type II interferon. The incubated mixture was centrifuged at about 1,000×g and 4° C. to remove precipitates such as cell debris, and the resulting supernatant was dialyzed against a physiological saline solution bufferized at pH 7.2 with a 0.01 M phosphate buffer, for 24 hours. Then, the resultant was filtrated carefully with a filter membrane and the Type II interferon-containing filtrate was concentrated and freeze-dried into powder. The Type II interferon activity of the powder was about 1,500,000 units per nude mouse. Example A-2 Adult nude mice were transplanted intraperitoneally with established human BALL-1 and TALL-1 cells, and fed in the usual way for 5 weeks. The nude mice were then injected intraperitoneally with 1 mg of phytohemagglutinin, and 24 hours later they were injected with about 3,000 hemagglutination units of Newcastle disease virus whose activity was almost pre-inactivated by ultraviolet irradiation. The nude mice were sacrificed to harvest their ascites 24 hours after the injection. The ascites was centrifuged at about 1,000×g and 4° C. to remove precipitates such as cell debris. The resulting supernatant was dialyzed against a physiological saline solution bufferized at pH 7.2 with a 0.01 M phosphate buffer, for 15 hours. The resultant was then filtrated and concentrated carefully with filter membranes to obtain a concentrate containing interferon. The total interferon activity of the concentrate was about 800,000 units per 10 nude mice, of which about 300,000 units was Type II interferon activity. Example A-3 New-born hamsters were pre-injected with antiserum prepared from rabbit according to the known method to depress their immunoreactions and then injected subcutaneously with established human JBL cells. The hamsters were fed in the usual way for 4 weeks. The massive tumors that occurred subcutaneously, about 30 g per hamster, were isolated and treated similarly as described in Example A-1. The multiplied cells were washed with RPMI-1640 medium supplemented with 10 v/v % of fetal bovine serum at pH 7.4 and suspended in a fresh medium of the same composition to give a cell concentration of about 2×10 7 cells per ml at 37° C. The mixture was added with a partially-purified high human species-specific Type II interferon in a proportion of about 200 units per ml and incubated at 37° C. for about one hour. The incubated mixture was then added with concanavalin A in a proportion of about 500 μg per ml, incubated for 3 days, then added with Sendai virus in a proportion of about 300 hemagglutination units per ml, and incubated for 16 hours to induce interferon. The mixture was purified and concentrated carefully with filter membranes similarly as described in Example A-2 to obtain an interferon-containing solution. The total interferon activity of the solution was about 17,000,000 units per hamster, of which about 6,000,000 units was Type II interferon activity. Example A-4 New-born rats were transplanted intravenously with established human Namalva cells and then fed in the usual way for 4 weeks. The massive tumors that occurred subcutaneously, about 50 g per rat, were isolated, cut finely and dissociated similarly as described in Example A-1. The multiplied human cells were treated similarly as described in Example A-1, except that Maruyama vaccin was added in a proportion of about 1 μg per ml to induce Type II interferon instead of phytohemagglutinin. The induced Type II interferon was purified and the resulting solution containing Type II interferon was freeze-dried into powder similarly as described in Example A-1. The Type II interferon activity of the powder was about 8,000,000 units per rat. Example A-5 At first, adult mice were irradiated with about 400 REM of X-ray to depress their immunoreactions, then transplanted subcutaneously with established human TALL-1 cells and fed in the usual way for 3 weeks. After isolating and cutting finely the massive tumors that occurred subcutaneously, about 10 g per mouse, the tumor cells were dissociated similarly as described in Example A-1. The cells were treated similarly as described in Example A-3 to induce interferon. The induced interferon was purified and concentrated similarly as described in Example A-2 to obtain a concentrate containing interferon. The total interferon activity of the concentrate was about 9,000,000 units per mouse, of which about 3,000,000 units was Type II interferon activity. Example A-6 Hamsters were first transplanted subcutaneously with established human MOLT-3 cells similarly as described in Example A-3 and fed in the usual way for 3 weeks to multiply the cells. Ten-day-old nude mice were then transplanted intraperitoneally with the multiplied cells and fed in the usual way for an additional 5 weeks. The nude mice were anesthetized to harvest their ascites. The obtained ascites was centrifuged to harvest the multiplied cells. The cells were washed and treated similarly as described in Example A-1 to induce Type II interferon. The induced Type II interferon was then purified and concentrated similarly as described in Example A-2 into a concentrate containing Type II interferon. The Type II interferon activity of the concentrate was about 500,000 units per nude mouse. Example A-7 Using plastic cylindrical diffusion chamber with interposed membrane filters, pore sizes of 0.5μ and capasities of about 10 ml, established human JBL cells were suspended in physiological saline solution. The chambers were embedded intraperitoneally in adult rats. The rats were fed in the usual way for 4 weeks and the chambers were removed. The concentration of the multiplied human cells in the chambers was about 5×10 9 cells per ml which was about 1,000 times or more higher than that attained in vitro in a nutrient medium using a CO 2 incubator. The suspension of the obtained cells was added with MOLT-3 cells prepared in Example A-6 to give a concentration of about 20 v/v % and the mixture was treated similarly as described in Example A-1 to induce Type II interferon. The induced Type II interferon was purified and concentrated into a concentrate containing Type II interferon which was then freeze-dried into powder. The Type II interferon activity of the powder was about 4,000,000 units per rat. Example A-8 Established human NALL-1 cells were transplanted in the allantoic cavities of embryonated eggs which had been pre-incubated at 37° C. for 5 days, and the eggs were incubated at this temperature for an additional 7 days. The eggs were opened and the multiplied human cells were harvested. The suspension of the cells was added in equivolume with TALL-1 cells prepared in Example A-5 and treated similarly as described in Example A-1 to induce Type II interferon. The induced Type II interferon was purified and concentrated similarly as described in Example A-2 to obtain a concentrate containing Type II interferon. The Type II interferon activity of the concentrate was about 300,000 units per 10 embryonated eggs. Example A-9 A powder prepared by the method described in Example A-1 was further purified carefully in a pH range of 4 to 9 with conventional methods such as adsorption and desorption by ion exchanger, fractionation according to the molecular weight with gel filtration, concentration and careful filtration, as described in Bodo's report, "Symposium on Preparation, Standardization and Clinical Use of Interferon. 11th International Immunobiological Symposium. 8 & 9 June (1977), Zagreb, Yugoslavia". A highly purified interferon preparation with a specific activity of 2×10 6 units per mg protein was obtained and the total recovery was about 40%. The results of EXPERIMENT B demonstrate that the Type II interferon obtained according to the methods described in the above Examples can be used solely, in combination with Type I interferon, or in mixtures with one or more other substances, as an effective therapeutic and/or prophylactic agent that can be used as injection or medicine for external or internal administration, for Type II interferon-sensitive diseases. EXPERIMENT B Therapeutic and prophylactic effects of Type II interferon on interferon-sensitive diseases EXPERIMENT B-1 Therapy of viral diseases with Type II interferon (inhibitory effect on viral multiplication in vitro) To mono-layers of human embryonic lung cells formed by primary culture in Petri dishes, 6 cm in diameter, were added 0.1, 1.0, or 10.0 units of the Type II interferon prepared by the method in Example A-9 and the obtained mixtures were incubated in a 5 v/v % CO 2 incubator at 37° C. for 20 hours. To the cells were added varicella zoster virus or human cytomegalo virus in the amount that forms 100 plaques in the absence of Type II interferon. The admixtures were incubated and the numbers of the formed plaques were counted. The inhibitory effect of Type II interferon on the viral multiplication was determined using the following equation. ##EQU1## wherein A is the number of the plaques formed in the absence of Type II interferon, and B the number of the plaques formed in the presence of Type II interferon. The results are shown in Table 2. TABLE 2______________________________________Type IIinterferon Varicella zoster virus Human cytomegale virus______________________________________0 unit 0% 0%0.1 unit 8% 6%1.0 unit 49% 54%10.0 units 88% 83%______________________________________ As obvious from the results in Table 2, the Type II interferon used in the present invention inhibited effectively the multiplication of the viral disease-causative virus. In the test, addition of the Type II interferon caused no abnormality in human cells. EXPERIMENT B-2 Therapy of non-viral diseases with Type II interferon (1) Inhibition of the tumor cell multiplication in vitro The Type II interferon prepared by the method in Example A-9 was added to RPMI-1640 medium supplemented with 15 v/v % fetal bovine serum to give the final concentration of 5, 50, or 500 units per ml. To the mixtures were transplanted various tumor cells to give the concentration of 5×10 5 cells per ml. The mixtures were then incubated in a 5 v/v % CO 2 incubator at 37° C. for 5 days and the numbers of the cells per ml medium were counted. Control experiments were carried out similarly as in the above experiments, except that a Type II interferon which was pre-inactivated by heating at 100° C. for 30 minutes was used. The inhibitory effect of Type II interferon on tumor cell multiplication was determined by the following equation. ##EQU2## wherein A is the number of the cells of the control, and B the number of the cells of the experiment with Type II interferon. The results are shown in Table 3. As obvious from the results shown in Table 3, the Type II interferon which was used in the present invention inhibited effectively the multiplication of the tumor cells such as BALL-1 cell, TALL-1 cell, NALL-1 cell and JBL cell, and was effective over an active concentration range of 5 to 500 units per ml. TABLE 3______________________________________Type II interferonconcentration Human tumor cell(units per ml) BALL-1 TALL-1 NALL-1 JBL______________________________________ 5 +17% +13% +19% +18%50 +55% +59% +61% +50%500 +84% +80% +86% +89%______________________________________ (2) Inhibition of the tumor cell multiplication in vivo The test was carried out with 8 nude mice, about 2-month-old. TALL-1 cells were transplanted subcutaneously in all 8 nude mice in the proportion of 7.5×10 6 cells per nude mouse. From the second day after the transplantation, 4 nude mice were given 3 intraperitoneal injections of 1,000 units of Type II interferon prepared by the method in Example A-6 a week, 20 injections in total. Forty eight days later, the nude mice were sacrificed and the wet weights of the occurred massive tumors were weighed. Control experiment was carried out with the remaining 4 nude mice similarly as in the above experiment, except that they did not receive Type II interferon. The results are shown in Table 4. TABLE 4______________________________________ Type II interferon-Experiment No. Control treated nude mouse______________________________________1 5.6 g 1.3 g2 4.5 g 0.8 g3 9.0 g 0 g4 6.3 g 0 gAverage weight 6.3 g 0.5 g______________________________________ (3) Inhibition of the tumor cell multiplication in vivo The test was carried out with 8 nude mice, about 2-month-old. Tumor JBL cells were transplanted subcutaneously in all 8 nude mice in the proportion of 1×10 7 cells per nude mouse. From the second week after the transplantation, 4 nude mice were given 2 intraperitoneal injections of 1,000 units of Type II interferon prepared by the method in Example A-2 a week, 8 injections in total. Forty two days later, the nude mice were sacrificed and the wet weights of the occurred massive tumors were weighed. Control experiment was carried out with the remaining 4 nude mice similarly as in the above experiment, except that they did not receive Type II interferon. The results are shown in Table 5. TABLE 5______________________________________ Type II interferon-Experiment No. Control treated nude mouse______________________________________1 4.7 g 0.5 g2 6.2 g 0.5 g3 15.3 g 0.5 g4 16.9 g 0.8 gAverage weight 10.8 g 0.6 g______________________________________ As obvious from the results in Table 4 and 5, the Type II interferon injection inhibited tumor formation, and also inhibited extremely development even when it occurred; the wet weights of the occurred massive tumors of the Type II interferon-treated nude mice were much less than those of the controls. In addition, the Type II interferon-treated nude mice showed better appetites and were more active than the controls. EXPERIMENT C Acute toxicity The acute toxicity test of the Type II interferon preparation prepared by the method in Example A-9 was carried out with 20-day-old mice, and demonstrated that the toxicity of said Type II interferon preparation was extremely low: LD 50 value, 20,000,000 units or more per kg in the case of intraperitoneal injection. As obvious from the above experiments, Type II interferon-sensitive diseases referred in the invention can be those which can be treated and prevented with the interferon prepared in accordance with the present invention; for example viral diseases such as epidemic keratoconjunctivitis, herpetic keratitis, influenza, rubella and serum hepatitis, and non-viral diseases such as certain types of cancer. The therapeutic and prophylactic agents containing Type II interferon that can be used for said Type II interferon-sensitive diseases are preparable in various forms and phases according to the use, for example liquid preparations for nebula, eye wash, nose drop, gargle and injection, paste preparation such as ointment, and solid preparations in powder, granule and tablet. The agents are sufficiently effective when Type II interferon contents are 1 to 10,000,000 units per g, and if desired, can be used in combination or in mixture with one or more other substances, for example therapeutic agent, vehicle, filler and stabilizer. Particularly, since interferon, when injected intravenously, is readily eliminated from blood within about 10 minutes and excreted from the system, instillation administration of interferon, for example by incorporating interferon into instillation sugar supplement solution, provides means to prolong the administration time to render full and effective utilization of the instilled interferon and to improve further the therapeutic and prophylactic actions of interferon on interferon-sensitive diseases. Several embodiments for Type II interferon-containing preparations according to the present invention are described below. EXAMPLE B Preparations containing Type II interferon Example B-1. Liquid preparation A liquid preparation was prepared by dissolving the Type II interferon-containing powder prepared by the method in Example A-1 in physiological saline solution in a proportion of about 500 units per ml. The preparation is suitable as nebula, eye wash, nose drop, and gargle in treating and preventing viral diseases; particularly, epidemic keratoconjunctivitis and influenza. Example B-2. Injection An injection was prepared by mixing the Type II interferon prepared by the method in Example A-9 in physiological saline solution in a proportion of about 100,000 units per ml. The injection is suitable for treating and preventing all Type II interferon-sensitive diseases including viral and certain tumorous diseases. Example B-3. Sugar supplemental injection solution A sugar supplemental injection solution for intravenous instillation was prepared by mixing 1,000,000 units of an interferon preparation, containing Type I and Type II interferons which were both prepared by the method described in Example A-5, and 100 mg of cyclophosphamide in 500 ml of a 10 w/v % aqueous maltose solution. The sugar supplemental injection solution is suitable as a continuous-intravenous-infusion solution for treating and preventing certain tumorous diseases. Example B-4. Injection An injection was prepared by dissolving 500,000 units of interferon preparation containing Type I and Type II interferons prepared by the method in Example A-2 and 2 mg of mitomycin C in 100 ml of a 10 w/v % aqueous maltose solution. The injection is suitable for treating and preventing tumorous diseases. Example B-5. Ointment An ointment was prepared according to the conventional method by mixing the powder prepared by the method of Example A-4, liquid paraffin and vaseline to give a Type II interferon activity of 10,000 units per g. The ointment is suitable for treating viral skin diseases. Example B-6. Tablet Tablets were prepared according to the conventional method by tabletting a mixture of the Type II interferon-containing powder prepared by the method in Example A-7, starch and maltose to give a Type II interferon activity of about 1,000 units per tablet (about 100 mg). The tablets are suitable for treating and preventing viral diseases that occurred in the digestive system. Example B-7. Liquid preparation A liquid preparation for oral administration was prepared by dissolving 5 mg of methotrexate and the concentrate having a Type II interferon activity of 200,000 units prepared by the method in Example A-8 in 10 ml of a 10 w/v % aqueous maltose solution. The preparation is suitable for treating and preventing certain tumorous diseases.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This is a continuation application of U.S. patent application Ser. No. 11/780,369, filed Jul. 19, 2007 (now U.S. Pat. No. 9,162,068), which is a continuation-in-part (CIP) application of U.S. patent application Ser. No. 11/778,486, filed Jul. 16, 2007 (abandoned). Priority is claimed to both of these patent applications, and both are incorporated herein by reference in their entireties. FIELD OF THE INVENTION The present invention relates to a driving circuit useable in a magnetically-coupled telemetry system, and has particular applicability to implantable medical device systems. BACKGROUND Implantable stimulation devices are devices that generate and deliver electrical stimuli to body nerves and tissues for the therapy of various biological disorders, such as pacemakers to treat cardiac arrhythmia, defibrillators to treat cardiac fibrillation, cochlear stimulators to treat deafness, retinal stimulators to treat blindness, muscle stimulators to produce coordinated limb movement, spinal cord stimulators to treat chronic pain, cortical and deep brain stimulators to treat motor and psychological disorders, and other neural stimulators to treat urinary incontinence, sleep apnea, shoulder sublaxation, etc. The present invention may find applicability in all such applications, although the description that follows will generally focus on the use of the invention within a Spinal Cord Stimulation (SCS) system, such as that disclosed in U.S. Pat. No. 6,516,227, which is incorporated herein by reference in its entirety. Spinal cord stimulation is a well-accepted clinical method for reducing pain in certain populations of patients. As shown in FIGS. 1A and 1B , a SCS system typically includes an Implantable Pulse Generator (IPG) 100 , which includes a biocompatible case 30 formed of titanium for example. The case 30 typically holds the circuitry and power source or battery necessary for the IPG to function, although IPGs can also be powered via external RF energy and without a battery. The IPG 100 is coupled to electrodes 106 via one or more electrode leads (two such leads 102 and 104 are shown), such that the electrodes 106 form an electrode array 110 . The electrodes 106 are carried on a flexible body 108 , which also houses the individual signal wires 112 and 114 coupled to each electrode. In the illustrated embodiment, there are eight electrodes on lead 102 , labeled E 1 -E 8 , and eight electrodes on lead 104 , labeled E 9 -E 16 , although the number of leads and electrodes is application specific and therefore can vary. As shown in FIG. 2 , the IPG 100 typically includes an electronic substrate assembly 14 including a printed circuit board (PCB) 16 , along with various electronic components 20 , such as microprocessors, integrated circuits, and capacitors mounted to the PCB 16 . Two coils are generally present in the IPG 100 : a telemetry coil 13 used to transmit/receive data to/from an external controller 12 as explained further below; and a charging coil 18 for charging or recharging the IPG's power source or battery 26 using an external charger (not shown). The telemetry coil 13 can be mounted within the header connector 36 as shown. As just noted, an external controller 12 , such as a hand-held programmer or a clinician's programmer, is used to send data to and receive data from the IPG 100 . For example, the external controller 12 can send programming data to the IPG 100 to dictate the therapy the IPG 100 will provide to the patient. Also, the external controller 12 can act as a receiver of data from the IPG 100 , such as various data reporting on the IPG's status. The external controller 12 , like the IPG 100 , also contains a PCB 70 on which electronic components 72 are placed to control operation of the external controller 12 . A user interface 74 similar to that used for a computer, cell phone, or other hand held electronic device, and including touchable buttons and a display for example, allows a patient or clinician to operate the external controller 12 . Wireless data transfer between the IPG 100 and the external controller 12 takes place via inductive coupling, and specifically magnetic inductive coupling. To implement such functionality, both the IPG 100 and the external controller 12 have coils 13 and 17 respectively. Either coil can act as the transmitter or the receiver, thus allowing for two-way communication between the two devices. When data is to be sent from the external controller 12 to the IPG 100 for example, coil 17 is energized with alternating current (AC), which induces an electromagnetic field 29 , which in turn induces a current in the IPG's telemetry coil 13 . The power used to energize the coil 17 can come from a battery 76 , which like the IPG's battery 26 is preferably rechargeable, but power may also come from plugging the external controller 12 into a wall outlet plug (not shown), etc. The induced current in coil 13 can then be transformed at the IPG 100 back into the telemetered data signals. To improve the magnetic flux density, and hence the efficiency of the energy transfer, the IPG's telemetry coil 13 may be wrapped around a ferrite core 13 ′. As is well known, inductive transmission of data from coil 17 to coil 13 can occur transcutaneously, i.e., through the patient's tissue 25 , making it particular useful in a medical implantable device system. During the transmission of data, the coils 13 and 17 lie in planes that are preferably parallel. Such an orientation between the coils 13 and 17 will generally improve the coupling between them, but deviation from ideal orientations can still result in suitably reliable data transfer. To communicate a serial stream of digital data bits via inductive coupling, some form of modulation is generally employed. In a preferred embodiment, Frequency Shift Keying (FSK) can be employed, in which the logic state of a bit (either a logic ‘0’ or a logic ‘1’) corresponds to the frequency of the induced magnetic field 29 at a given point in time. Typically, this field has a center frequency (e.g., fc=125 kHz), and logic ‘0’ and ‘1’ signals comprise offsets from that center frequency (e.g., f0=121 kHz and f1=129 kHz respectively). Once the data is modulated in this manner at the transmitting device (e.g., the external controller 12 ), it is then demodulated at the receiving device (e.g., the IPG 100 ) to recover the original data. While FSK modulation may be preferred for a given application, one skilled in the art will recognize that other forms of data modulation (e.g., amplitude modulation, On-Off-Keying (OOK), etc.) can be used as well. These modulation schemes as used in a medical implantable device system are disclosed in U.S. Pat. No. 7,177,698, which is incorporated herein by reference in its entirety, and because they are well known, they are not further discussed. A typical driving circuit (or an amplifier circuit) 150 used to energize the transmitting coil is shown in FIG. 3 . In the example shown it is assumed that the external controller 12 is acting as the transmitter, although it should be remembered that the IPG 100 could also act as the transmitter. The driving circuit 150 comprises a RLC circuit (or as it is sometimes known in the art, a “tank circuit” or “resonant circuit”), in which the inductor (L) comprises the coil 17 in the external controller discussed previously. As one skilled in the art understands, the RLC circuit is made to resonate by the application of a clock signal to switches 152 and 152 ′. Specifically, in the embodiment shown, switches 152 and 152 ′ are toggled out of phase, which is accomplished using clocking signals, Clk and Clk′, which are the inverse or complement of each other. The clock signals are derived from a modulation circuit 170 , which converts the incoming data bit stream (Din) into clock signals with offset frequencies f0 and f1 indicative of the logic state of the bits. This induces a resonance in the RLC circuit, with the result that a magnetic field 29 is produced that wirelessly communicates the modulated data. In other words, a wireless modulated data signal 29 is produced. The driving circuit 150 of FIG. 3 has advantages and disadvantages, particularly as relates to the use of the resistor R in the circuit. One advantage of using resistor R is that it results in a wider frequency response characteristic of the RLC circuit as shown to the right in FIG. 3 . That is, the amplitudes of the two frequencies f1 and f0 as produced in magnetic field 29 are insensitive to small variations of f1 and f0. This property of the RLC circuit makes detection at the receiver side of the communication (e.g., at the IPG 100 ) simpler: in the case the receiver's tuning does not exactly match the frequencies (f0 and f1) of the transmitter, f0 and f1 values can be adjusted by the transmitter without affecting their amplitudes to a significant degree, thus improving the likelihood of successfully detecting the communicated signal. Additionally, the resistor helps to dampen the resonance of the resonant circuit. This is important to the data rate or “bandwidth” of the communication. If resonance at one frequency (e.g., f0) can be dampened relatively quickly, a next bit of the other frequency (e.g., f1) can be accurately produced that much more quickly, which in turn allows the data rate of the communication to increase. However, the resistor R also produces a significant disadvantage, namely excessive power consumption. As one skilled in the art will appreciate, a resistor dissipates energy, and hence operation of the driving circuit 150 of FIG. 3 will need to consume more power by virtue of the passage of current through the resistor, R. In this regard, note that the driving circuit 150 is powered by the external controller 12 's rechargeable battery 76 . Because ease in use and portability suggests that the external controller 12 have an internal battery 76 , it is appreciated that this battery 76 should preferably last as long as possible, thus saving the user from the inconvenience of frequently having to recharge the battery 76 , or replace a non-rechargeable battery 76 with a fresh battery. Viewed from another perspective, excessive power consumption in the driving circuit 150 effectively limits the operable distance between the external control 12 and the IPG 100 , given that power consumption and distance are proportional. To summarize, the driving circuit 150 illustrated in FIG. 3 can be said to have a low quality factor or “Q factor,” because the ratio of the energy in the produced field 29 to the energy used to produce that field is relatively low. FIG. 4 illustrates another prior art driving circuit 150 ′, and particularly illustrates a simplified version of the approach disclosed in U.S. Pat. No. 6,349,116, which is hereby incorporated by reference in its entirety. In this circuit, a FSK modulated field 29 is also produced, but without the use of any significant resistances, R. Instead, a LC resonant circuit is formed by connecting the coil 17 and a base capacitor C 0 in parallel. This basic resonant circuit is made to resonate via control of a switch 154 which is clocked at the higher offset frequency, f1. The data modulates the frequency of the produced oscillation by switching in another capacitor, C(fsk), via switch 156 , again in parallel with L and C 0 . This has the effect of changing the resonant frequency to the lower offset frequency, f0, and thus by this arrangement, both frequencies f0 and f1 can be transmitted by either including or excluding the additional capacitance, C(fsk). But just like the driving circuit of FIG. 3 , driving circuit 150 ′ too has its advantages and disadvantages. Advantageously, because the driving circuit 150 ′ lacks a substantial resistance, the circuit is very energy efficient, and has a high Q factor. In other words, the driving circuit 150 ′ does not overtax the battery 76 , and thus allows for relatively long battery life and/or longer operating distances between the external controller 12 and the IPG 100 . However, disadvantageously, driving circuit 150 ′ produces a wireless modulated data signal 29 with relatively narrow frequency response characteristic, as shown to the right in FIG. 4 . As discussed above, this makes reception of the wireless data more difficult, and requires good matching between the transmitter and the receiver. In fact, the '116 patent specifically attempts to remediate this concern by providing a bank of additional tuning capacitors, C( 1 ) through C(n). As shown in FIG. 4 , these tuning capacitors C( 1 ) through C(n) must be selectively switched in parallel with the base capacitor C 0 using switches 158 ( 1 ) through 158 ( n ). This is regrettable, because this requires additional overhead and circuitry necessary to assess the produced frequencies and to tune them accordingly. Such added complexity makes driving circuit 150 ′ a poor choice for utilization in portable devices, and even more so for the case of implantable devices. From the foregoing, it should be clear that the art of magnetically-coupled telemetry systems would benefit from a new driving circuit, one which: produces a relatively wide frequency response which allows for the reception of signals f0 and f1 without additional trimming and complexity; is able to quickly transition between logic states to enable high-speed, high-bandwidth data transfer; and is respectful of power consumption and/or can increase the operating distance between the external controller and the IPG. This disclosure provides embodiments of such a solution. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1A and 1B show an implantable pulse generator (IPG), and the manner in which an electrode array is coupled to the IPG in accordance with the prior art. FIG. 2 shows the relation between the IPG of FIG. 1 and an external controller with which it communicates via magnetic inductive coupling. FIGS. 3 and 4 show prior art driving circuits for driving a coil to produce wireless data signals via magnetic inductive coupling. FIGS. 5 and 6 show embodiments of an improved driving circuit in accordance with the invention. DETAILED DESCRIPTION The description that follows relates to use of the invention within a spinal cord stimulation (SCS) system. However, it is to be understood that the invention is not so limited. Rather, the invention may be used with any type of implantable medical device system that could benefit from improved communications between an external controller and the device. For example, the present invention may be used as part of a system employing an implantable sensor, an implantable pump, a pacemaker, a defibrillator, a cochlear stimulator, a retinal stimulator, a stimulator configured to produce coordinated limb movement, a cortical and deep brain stimulator, or in any other neural stimulator configured to treat any of a variety of conditions. One embodiment of the improved driving circuit 200 is shown in FIG. 5 , which offers significant improvement in power efficiency while at the same time being easy to implement. As will be discussed further below, the driving circuit 200 allows some of the excess current produced during resonance of the coil L to be shunted back to the rechargeable battery in the transmitter (e.g., the external controller). In so doing, the driving circuit 200 is naturally dampened, but in a way that is considerate of battery capacity. The result is a driving circuit which has a relatively broad frequency response profile. This allows frequencies f0 and f1 to be adjusted by the transmitter to match receiver characteristics without using additional circuits or hardware; is relatively responsive to allow for fast transitions between logic states and fast data rates; and is energy efficient. The driving circuit 200 of FIG. 5 uses a transformer 202 with a primary winding L 1 (which comprises the coil 17 in the external controller 12 for example) and a secondary winding L 2 in a transformer feedback configuration. As shown, no discrete resistors (such as used in the approach of FIG. 3 ) are used in the resonant circuit, which comprises the resonance capacitor, C and the equivalent inductance L of the primary coil of the transformer 202 . The circuit 200 produces a center resonance frequency, fc, in a medical implantable system application of about 125 kHz, where fc=(2π*sqrt(LC)) −1 . The primary winding L 1 ( 17 ) in conjunction with capacitor C, are made to resonate by toggling switches 160 and 160 ′. Because the switches 160 and 160 ′ are controlled with complementary clock signals, Clk and Clk′, Vbat is applied to the resonant circuit with alternating polarities. Driving the resonant circuit from both of its ends by the two switches 160 and 160 ′ has the benefit of doubling the voltage across coil L 1 and thus doubling magnetic field 29 . However, the use of two switches 160 and 160 ′ is not strictly necessary, and instead a single switch can be used in driving circuit as well (such as will be illustrated in the alternative embodiment of FIG. 6 below). The windings or coils L 1 and L 2 in the transformer 202 have N 1 and N 2 turns respectively, which set the relation of the voltages across them: VL 1 =VL 2 *N 1 /N 2 . The voltage produced on the secondary winding L 2 , VL 2 , is connected to the battery 76 via a diode D. This has the effect of limiting VL 2 to the battery voltage, Vbat. (This assumes that the threshold voltage of the diode is negligible, i.e., Vt≈0). Should VL 2 try to exceed Vbat during resonance, the diode D becomes forward biased (again, assuming that the diode has a threshold voltage of zero, i.e., Vt≈0), and a battery recovery current, i e , flows to the battery 76 . Such current flow limits the potential of VL 2 to Vbat, which in turn clamps the voltage across the coil 17 L 1 to a maximum value: VL 1 max=Vbat*(N 1 /N 2 ). (Should a significant diode threshold voltage Vt be present, this equation is modified as follows: VL 1 max=(Vbat+Vt)*(N 1 /N 2 )). By contrast, when VL 2 is less than Vbat during resonance, the diode D prevents the flow of current out of the battery 76 (i e ≈0) to prevent discharging. The bypass capacitor Cbp reduces the peak current flowing in/out of the rechargeable battery 76 to provide for stability. By shunting the recovery current i e to the rechargeable battery 76 , the battery 76 is recharged. Such recharging occurs during a portion of the time that the circuit is resonating, i.e., when the resonance produces high voltages across the coil 17 that (absent clamping) would exceed Vbat*(N 1 /N 2 ). The result is an energy efficient solution rivaling that of the solution depicted in FIG. 4 . This is not without its drawbacks: because VL 1 is clamped to VL 1 max, the magnetic field of the wireless modulated data signal 29 produced by the coil 17 is also limited, and thus the driving circuit 200 effectively acts as a low-Q-factor circuit. However, and unlike the solution of FIG. 3 , such magnetic field reduction does not result from energy dissipation caused through the use of a discrete resistor. Moreover, shunting the recovery current i e assists in dampening the resonance, which allows the driving circuit 200 to switch frequencies, and hence data states, more quickly, enabling the transmission of higher data rates. Such active dampening also tends to spread the width of the resonance of the driving circuit (i.e., at 121 kHz and 129 kHz). This eases the need to precisely match hardware components of the driving circuit 200 to that of the receiver, and hence allows the driving circuit to be constructed of components of lesser accuracy. The various values for the components used in the improved driving circuit 200 of FIG. 5 may be as follows for the medical implantable device system for which the circuit was originally developed. N 1 =˜22 turns; N 2 =˜3 turns; L 1 =34 μH; C=0.047 μF; Vbat=4.1V; Cbp=100 μF. However, in a different application, different component values could be chosen. FIG. 6 depicts an alternative driving circuit 200 ′. Like the driving circuit 200 of FIG. 5 , the driving circuit 200 ′ of FIG. 6 also lacks a discrete resistor, but also allows for excess resonance energy to be shunted back to the battery 76 for the purpose of dampening and recharging. Driving circuit 200 ′ employs a single inductor L (i.e., the coil of the external controller 12 for example). A tap point 82 is added to the transmit coil 17 (in what is known in the art as an autotransformer configuration) to connect the coil 17 to the rechargeable battery 76 via a diode, D. The number of turns in the coil above (N 1 ) and below (N 2 ) the tap point 82 relates the voltage across the coil (VL) to the voltage at the tap point 82 (Vtap). Specifically, VL=Vtap*(N 2 +N 1 )/N 2 . As in the transformer feedback configuration of FIG. 5 , the diode D has the effect of clamping the voltage across the coil 17 to a maximum, VLmax. This is because the voltage at tap point 82 (Vtap) cannot exceed the battery voltage (Vbat). Should Vtap try to exceed Vbat during resonance, the diode D becomes forward biased (assuming that the diode has a threshold voltage of zero, i.e., Vt≈0), and a battery recovery current, i e , flows to the battery 76 . Such current flow limits the potential of Vtap to Vbat, which in turn clamps the voltage across the coil 17 to a maximum value: VLmax=Vbat*(N 2 +N 1 )/N 2 . (Should a significant diode threshold voltage Vt be present, this equation is modified as follows: VLmax=(Vbat+Vt)*(N 2 +N 1 )/N 2 ). By contrast, when Vtap is less than Vbat during resonance, the diode D prevents the flow of current out of the battery 76 (i e ≈0) to prevent discharging. As with the driving circuit 200 of FIG. 5 , the center frequency of resonance is fc=(2π*sqrt(LC)) −1 , where L comprises the inductance of the coil L 17 . The effect, as with the driving circuit 200 of FIG. 5 , is that recovery current i e is shunted to the rechargeable battery 76 during high voltage portions of the resonance, providing a very energy efficient solution. Although VL is clamped to VLmax, which limits the magnetic field producible by the coil 17 , such magnetic field reduction does not result from energy dissipation caused through the use of a discrete resistor. And once again, shunting the recovery current i e to the battery assists in dampening the resonance, which allows for the transmission of higher data rates. Additionally, and as before, such active dampening also tends to widen the resonant response of the resonant circuit, easing reception without the need for hardware trimming. The various values for the components used in the improved driving circuit 200 ′ of FIG. 6 may be as follows for the medical implantable device system for which the circuit was originally developed. N 1 =˜20 turns; N 2 =˜4 turns; L=34 μH; C=0.047 μF; Vbat=4.1V; Cbp=100 μF. However, in a different application, different component values could be chosen. The disclosed driving circuits can be used with any switching type amplifier (Class C, D, E, H, etc.), and for both the transformer feedback configuration ( FIG. 5 ) and the autotransformer ( FIG. 6 ) configuration. While disclosed in the context of a medical implantable device system for which the invention was originally contemplated, it should be recognized that the improved driving circuitry disclosed herein is not so limited, and can be used in other contexts employing communications via magnetic inductive coupling, such as in Radio-Frequency Identification (RFID) systems, etc. The disclosed circuitry can further be used in any context in which magnetic inductive coupling could be used as a means of communication, even if not so used before. Although particular embodiments of the present invention have been shown and described, it should be understood that the above discussion is not intended to limit the present invention to these embodiments. It will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present invention. Thus, the present invention is intended to cover alternatives, modifications, and equivalents that may fall within the spirit and scope of the present invention as defined by the claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application is entitled to the benefit of and incorporates by reference essential subject matter disclosed in German Patent Application No. 103 11 156.5 filed on Mar. 14, 2003. FIELD OF THE INVENTION The invention concerns a vehicle with an attachment, which has a lifting drive with at least one hydraulic cylinder and a control device, said control device having a position sensor and a position indicator. BACKGROUND OF THE INVENTION In the following, the invention is described on the basis of a tractor, whose toolbar (hitch) can be used for fitting different attachments. This could, for example be a plough, a harrow, a mower or another tool. However, the invention is not limited to a tractor being the vehicle. Also other vehicles can have attachments, for example street sweepers, forestry machines etc. During operation, the attachment should be set to a position, that is, a height, which corresponds to the application purpose. For example, a plough, which is fixed on a tractor, should be able to penetrate to a certain depth into the earth. A too large or a too small depth in not wanted. However, the set position is not maintained for the whole operation duration of the tractor. For example, the plough has to be lifted, when the tractor leaves the field to drive to another field. The plough also has to be lifted, when the tractor changes its driving direction, however, the blocks should be thrown in the same direction. After the lifting, the plough has to be returned to the previously set position. The combination of a hydraulic cylinder and a control device forms part of an electro-hydraulic position control. When, during lifting, the amount of hydraulic fluid supplied to the cylinder is controlled, a substantially load independent lifting movement can be realised. The speed of the cylinder in the lifting direction can be kept substantially proportional to a control signal. The maximum speed of the cylinder is thus proportional to a maximum desired value of the control signal, and the amplification is constant and independent of the load. When lowering the load, that is, the attachment, however, it is different. Particularly with single-acting cylinders, the lowering movement can usually not be made load independently. Attachments with a higher weight sink faster than attachments with a lower weight. This leads to variants in the rule amplification in connection with the position control for varying loads. From U.S. Pat. No. 4,846,283 is known a vehicle, with which the lowering speed of the attachment can be braked. To a certain limit, a control signal and thus the maximum deflection of the valve can be adjusted. This applies for a predetermined load. When, however, the load changes, a new adjustment or setting is required. U.S. Pat. No. 6,016,875 describes a control, which sets the amplification iteratively, which is proportional to the desired lifting speed. The process shown is based on an overshoot and requires some iteration steps. During this iteration, the driver may have an unpleasant feeling, when the acceleration changes. U.S. Pat. No. 5,320,186 describes a method of achieving a constant and load-independent maximum speed when changing the position of the attachment. This method uses a speed control, which differentiates the position of the attachment numerically, in order to detect its speed. This speed is compared with a desired speed, in order to detect a speed error, which is then supplied to an integrator. Thus, this control substantially corresponds to a proportional position error control having a ramp function as reference. The gradient of the ramp is the desired speed. In controls with a simple design, this method may lead to too high speeds. In controls, situations may occur, in which the position control and the speed control work against each other, which involves the risk that too high speeds occur. Additionally, too high accelerations may occur. On the one hand, these may cause damage. On the other hand, when lifting the load, the front wheels may lift off from the ground, which can lead to dangerous situations. Based on the foregoing, it is the general object of the present invention to improve the position control of the attachment. SUMMARY OF THE INVENTION With a vehicle as mentioned in the background, this task is solved in that the control device has a trajectory generator, which generates a trajectory in dependence of a desired position value and an acceleration limit, said trajectory being optimised with regard to a time specification, and a follower, which controls the lift drive in dependence of the trajectory. With this embodiment it is achieved that the attachment can be moved to the desired position without the occurrence of inadmissibly high acceleration values. The trajectory generator endeavours to place the movement in a “time window”, which is specified by the time specification. Usually, the user of the vehicle will select the time to be as short as possible. However, it is also possible for him to specify a longer time on purpose. The time specification results in a speed, with which the attachment should be moved. However, the trajectory generator limits the speed increase and the speed decrease so that no inadmissibly high accelerations and thus no inadmissibly high forces occur. It is also advantageous, when the trajectory generator also takes at least one speed specification into consideration. In this case, for example, the speed can be limited. Preferably, the acceleration limit is adjustable. The user can then adapt the maximum permissible acceleration to various attachments. For example, with light attachments larger acceleration values may be acceptable than with heavier attachments. It is also preferable that the time specification is adjustable. The user can then decide if, for the movement of the attachment, he will accept a longer or a shorter time. However, it must be observed that the selection of the time specification does not always ensure that this time specification is always achieved. Limits are, for example, set by the acceleration limit. In certain cases, also speed specifications have to be considered, for example a maximum speed. In each case, however, the trajectory generator will try to approach the time specification as much as possible. In addition, it is desirable that the control device has an inlet control and an outlet control for the cylinder. Thus, both the lifting movement and the lowering movement of the cylinder can be adjusted. This applies for both a cylinder in the form of a single-acting cylinder and a cylinder in the form of a double-acting cylinder. Preferably, the outlet control has electronic control means. The inlet control is relatively easily realised, for example via a pressure control valve, which keeps the pressure over a control valve constant. As, particularly with a single-acting cylinder, the outlet control depends on being driven by the weight of the attachment, such a control cannot always be realised. In this case electronic control means can be used, which ensure a larger flexibility. It is preferred that the outlet control has a flowmeter and a pressure sensor. Here, the term “flowmeter” is mainly to be understood functionally. The crucial point is to measure the flow. For this purpose, the “flowmeter” can either be mechanical or electronic. For example, also a pressure drop over the valve can be measured, or the absolute pressure, when tank pressure rules on the other side of the valve. When the opening of the valve is known, for example due to an electrical control of the valve, the flow is also “known”. Preferably, the pressure sensor has a signal outlet, whose signal can be processed electronically, for example by a microcontroller or a microcomputer. Preferably, the control device has a valve arrangement, which controls the outlet of the cylinder, and the outlet control forms an inverted model of the valve arrangement that uses pressure. By means of this inversed model a control can be realised, which can, at least for certain distances, do without a feedback. This simplifies the control. It is preferred that the transfer function of the trajectory to the inversed model results in the unit function. To put it more simply, the multiplication of the trajectory with the inversed model gives the value 1. The subsequent control of the position, for example because of the pressure, is then further simplified. In an alternative embodiment it may be ensured that the outlet control has an estimation function, which uses a load pressure and is part of a control circuit. In this case, the outlet of the cylinder is estimated by means of measured parameters, for example pressure, and the estimated value is compared with a specified value. Thus, a trajectory can also be followed with a good proximity. Preferably, the follower is made to be adaptive. Thus, it adapts, when errors occur. BRIEF DESCRIPTION OF THE DRAWINGS In the following, the invention is described in detail on the basis of preferred embodiments in connection with the drawings, showing: FIG. 1 shows a schematic view of a control of an attachment FIG. 2 shows a first embodiment of an outlet control FIG. 3 shows a second embodiment of an outlet control FIG. 4 shows various speed courses FIG. 5 shows a first embodiment of a follower FIG. 6 shows a second embodiment of a follower DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows a schematic view of an attachment 1 in a vehicle (not shown in detail), for example a toolbar of a tractor. The attachment 1 has a hydraulic cylinder 2 , which in the present embodiment is made as a single-acting cylinder. However, it is also possible to use a double-acting cylinder instead of a single-acting cylinder 2 . A control device 3 , which will be explained in detail in the following, controls the cylinder 2 . A load 4 is attached to attachment 1 to show that the attachment must be able to lift a corresponding load. The load 4 can, for example, be a plough, which must be pulled by a tractor. This plough must have a certain penetration depth into the earth. This penetration depth is achieved in that the attachment 1 is set to a certain height position, in the following called “position”. In FIG. 1 , this position is shown by “x”. However, it is not sufficient to set this position once. When the tractor changes its driving direction, and the plough has to throw the blocks in different directions, or when the tractor leaves the field, the plough must be lifted. After reassuming the work, the plough has to be lowered to the desired position again. For this purpose, the control device 3 has a 3-way, 3-direction control valve 5 in the form of a proportional valve. By means of the control valve 5 it is possible to let hydraulic fluid flow from a pressure connection P to the inlet A of the hydraulic cylinder 2 to lift the load. Or the load 4 can be lowered by means of the control valve 5 by connecting the inlet A of the cylinder 2 with a tank outlet R 1 . Alternatively, the control valve 5 can also be divided into two valves, as known, for example, from U.S. Pat. No. 6,058,343. In this case, one valve serves the purpose of lifting the load 4 and one serves the purpose of lowering the load 4 . In the case of a double-acting cylinder, a valve can be used, which controls four ways and three directions. Also such a valve can be divided into two valve parts or four valve parts for the separate control of the individual functions, as known from U.S. Pat. No. 5,960,695. The hydraulic system, which comprises the cylinder 2 and the control device 3 , has a pilot-controlled non-return valve 6 , which can be used, when it is desired to avoid a leakage from the connection A, so-called zero-leakage. In this connection, FIG. 1 shows that a pilot pressure Pf is supplied to the pilot-controlled non-return valve 6 via the control valve 5 . Alternatively, the pilot pressure can be supplied directly or via a solenoid valve. This causes that the non-return valve 6 can be controlled independently of the position of the control valve 5 . This may be advantageous in cases involving a control, in which the dynamics of the pilot-controlled non-return valve 6 plays a role. For the inlet control is used a pressure control valve 7 , which produces a constant pressure drop over the control valve 5 . Thus, in wide limits, a load-independent lifting behaviour of the cylinder 2 can be achieved. For the outlet control is used a pressure sensor 8 and a microcontroller 9 . The pressure sensor 8 produces an output signal, which can be evaluated by the microcontroller 9 . The pressure compensation can be made in different ways, for example by means of a feedback linearisation or with a flow estimation function and control. The microcontroller 9 also serves as position sensor, that is, it detects the position “x”. This is shown schematically by a line from “x” to the microcontroller 9 . FIG. 2 shows the principle of the feedback linearisation. The measured pressure drop ΔP, that is, the pressure difference between the connection A of the cylinder 2 and the outlet R 1 , is led back to an inverted model 10 of the valve 5 , which results in a linearised feedback system, in which the desired flow Q r is equal to the flow Q, independently of the load pressure. k is a valve constant. FIG. 3 shows a model, which uses an estimation function to control the outlet of fluid from the cylinder 2 . The estimated flow Q est is fed back and compared with the specified reference flow Q r in a controller R. This flow is simply estimated in that the pressure difference ΔP between the connection A of the cylinder 2 and the return connection R 1 , and the valve control signal U, are converted with a throttling behaviour. Also in this case it can be achieved with good proximity that the flow Q leaving the cylinder 2 is in fact equal to the desired flow Q r . When a double-acting cylinder is used instead of the hydraulic cylinder 2 , and for this reason the inlet control and the outlet control is separated, for example with two or four control valves, then the outlet pressure and the inlet pressure must be controlled to avoid that the load 4 runs away. However, in many cases the separation is not required. When a 4-way, 3-direction valve (4/3-valve), which is controlled on the basis of the flow (meter-in flow controlled valve), is used to control the double-acting cylinder, the flow in both directions is proportional to the control signal, provided that the valve has been dimensioned correctly for the maximum load. In this case a return-flow measuring (meter-out) is not required. As the flow control device produces a linear function between the desired flow value inlet Q r and the speed of the load dx/dt, the fastest movement time, as shown in FIG. 4 , between the positions x 0 and xf is the time t min (in seconds), v max being the maximum speed at completely open valve 5 and a load pressure ΔP. When a lower speed v set is desired, the opening time t set of the valve 5 must be longer to achieve the same movement. Theoretically, the linear profiles shown require an indefinitely large acceleration. In practice, the pressure ΔP limits the acceleration, with large loads it may, however, happen anyway that the front wheels leave the ground, because the inertia forces are too large. For this reason, an acceleration limit is introduced, as shown in FIG. 4 . The acceleration profile has a maximum a and a minimum −a. The position of the load is simply found in that the acceleration profile is integrated twice and the desired speed v set is included, that is, is used as integration limit. This gives a controlled acceleration, which, however, causes a somewhat longer movement time tf. The profile is optimal in that it gives the shortest movement time for a predetermined maximum acceleration and a maximum speed. The speed can also be replaced by a time specification. A further integration will convert the speed profile to a trajectory for the movement of the load 4 or the attachment 1 , respectively. This is obvious to a person skilled in the art and therefore not shown in detail. When other acceleration limits are chosen, the speed course will change. However, in any case it can be avoided that a maximum acceleration is exceeded. When a monitoring of both acceleration and speed is wanted, the desired trajectory gets somewhat more complicated. For this reason, a follower is expedient. FIG. 5 shows a first embodiment of such a follower. As described above, a trajectory generator 11 produces a trajectory, that is, the individual positions x over the time, as shown, for example in FIG. 4 . The control has a directly connected part, which represents an inverted model 12 of the attachment 1 . The transfer function from x r (specification) to x will thus be 1. This does not necessarily mean that x r =x, and also not that x approaches the course x r . As, however, the attachment system itself is unstable, a position control with a controller C is additionally used. The immediate position x of the load 4 is supplied to this controller C. The effect of this measure is that x approaches the specification x r and that the control system gets stabler in relation to parameter variations and interferences. In a preferred embodiment, the model approaches the attachment with a constant and an integrator in such a manner that the inverted model becomes a constant and a differentiator. The approach simplifies the control and is sufficiently accurate for moderate accelerations. The controller C is dimensioned so that the control system has a predetermined stability area. It is expedient to arrange a dead-band compensator 14 between the outlet control 13 , as shown, for example, in FIG. 2 or FIG. 3 , and the system of the attachment 1 , in order to compensate a dead-band db, which is required in the valve 5 to let the load-sensing and pilot pressure signals pass. Of course, the system described can be used in both directions, that is, both when lifting and when lowering a load. During lifting, the outlet control 13 will play no role. An alternative method for combining an outlet control and a follower is shown in FIG. 6 . This embodiment comprises an adaptive follower. In this case an outlet control is not absolutely necessary, when the load is constant or changes slowly. The adaptive follower adapts the inverted model of the system of the attachment 1 .

1a

This is a divisional of application Ser. No. 08/049,425 filed on Apr. 20, 1993, now U.S. Pat. No. 5,339,511. BACKGROUND OF THE INVENTION This invention relates generally to the art of intravenous bags (IV-bags) and more specifically to devices for charging IV-bags with medications and the like. IV-bags are used in large quantities in hospitals, clinics and other facilities where patients are being treated. In this regard, IV-bags are not only used for giving blood transfusions, but are also used extensively for providing nourishment and medications to patients. Regarding medications, they are often administered intravenously mixed in a saline or sugar carrier solution. It is important that many of these medications not be mixed with the carrier solutions in the IV-bags until immediately before the mixtures are to be "fed" into patients. Further, it is extremely important that IV-bags be charged with the correct medications for corresponding patients. That is, it would be extremely easy for nurses who would both prepare IV-bags and administer them to patients to become confused and administer the wrong medications to patients. Also, it is not a good idea to combine the medications with the IV-bags on hospital floors where conditions are less than sterile. Thus, most hospitals, especially larger hospitals, have found it to be beneficial for technicians to combine medications with IV-bags in sterile laboratories and then deliver these "combined bags", properly marked as to patients and medications, to the appropriate hospital rooms. A nurse then, upon administering an IV to a patient, checks the marked medication against the patient's chart and, if they correspond, she activates the medication so that it is only then mixed with the carrier solution, immediately before the IV is administered. Normally, medication vials are combined, or assembled, with IV-bags by screwing male-threaded necks of the medication vials into female-threaded mouths of the IV-bags, with sterile stoppers of the medication vials extending into the IV-bags. The medication vials are then left, thus attached, or screwed, to the IV-bags until they are to be used. In order to use an IV-bag with an attached medication vial, a nurse manipulates the flexible bag itself to cause a stopper remover in the bag to remove the stopper from the medication vial, with the stopper remover and stopper falling into the interior of the bag, thereby allowing the medication in the medication vial to enter into the IV-bag and mix with a carrier solution therein. Although the above described system functions quite well, it has been found that it is extremely burdensome for and dangerous to technicians who must assemble the medication vials with the IV-bag. In this regard, often hundreds of medication vials are combined with IV-bags daily, thereby requiring many repetitions of screwing male threads on necks of medication vials into female threads on mouths of IV-bags. When these two members are being screwed together, the stopper remover is simultaneously screwed into an opening of the stopper. Thus, the screwing action involves overcoming much friction and, therefore, requires the expenditure of quite a bit of effort. Not only is this procedure unduly slow and burdensome for the technicians, it is also not accurate and increases the risk of getting a wrist abnormality known as "Carpal Tunnel Syndrome". Therefore, it is an object of this invention to provide a tool and method for attaching medication vials to IV-bags which is fast, not unduly burdensome, and does not increase the risk of getting carpal tunnel syndrome. Similarly, it is an object of this invention to provide a tool and method for attaching medication vials to IV-bags which is not unduly expensive. SUMMARY According to principles of this invention, a tool and method for screwing medication vials onto IV-bags involves a socket having a resilient material lining for defining a vial-receiving cavity of a size and shape for receiving a bottom end portion of a vial with the lining material engaging the received bottom end for imparting movement from the socket to the vial for screwing the neck of the vial into an IV-bag. In one embodiment, the socket includes a removable retainer at a lip of a mouth of the socket for releasably holding an annularly-shaped resilient material insert in the socket. In one embodiment of the invention, the tool further comprises a rotating hand tool which is attached to the socket for rotating the socket. In a preferred embodiment, the socket is continuously rotated by a table mounted motor. Bottom ends of vials are inserted therein and IV-bags are manipulated to bring them into engagement with spinning threaded necks of the vials and for removing the vials from the socket. BRIEF DESCRIPTION OF THE DRAWINGS The invention is described and explained in more detail below using the embodiments shown in the drawings. The described and drawn features, in other embodiments of the invention, can be used individually or in preferred combinations. The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of a preferred embodiment of the invention, as illustrated in the accompanying drawings in which reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention in a clear manner. FIG. 1 is an exploded, partially cross-sectional and partially cut-away side view of a socket of the tool of this invention along with a medication vial and an IV-bag; FIG. 2 is a side view of a medication-vial hand tool of this invention while holding and manipulating a vial which has been taken from a rack depicted in FIG. 3; FIG. 3 is a cutaway side view of a plurality of medication vials being held in a rack to be manipulated by the hand tool of FIG. 2; and FIG. 4 is a schematic, partially-exploded, segmented, partially-cutaway, view of a table-mounted embodiment of this invention shown mounted on a table while assembling a medication vial with an IV-bag. DESCRIPTION OF THE PREFERRED EMBODIMENT A medication vial 10 of a type with which this invention is normally used is generally constructed of a glass container 12 with a resinous plastic coaster 14 surrounding and attached to a closed bottom end portion 16 of the container 12 and a rubber stopper 18 which is inserted into a mouth of a male threaded neck 20 of the container 12. Male threads 22 of the threaded neck 20 are designed to screw into female threads 24 of a mouth 26 of an IV-bag 28. The IV-bag 28 is comprised of a flexible, translucent, thin-plastic bag portion 30 for holding fluid therein, and a hard mouth portion 32 for defining the female threads 24 which mate with the male threads 22 of the glass container 12. Another feature of this prior art IV-bag system is a stopper remover 34 which is snapped onto a lower end 36 of the hard mouth portion 32. This stopper remover 34 also serves as a cover for the IV-bag 28 in that it has an O-ring seal 38 which forms a seal between the hard mouth portion 32 and a hard portion of the stopper remover 34 so that a carrier fluid, solution, or liquid, which is in the bag portion 30 of the IV-bag 28 cannot prematurely escape through the mouth 26 of the IV-bag 28. But additionally, the stopper remover, has a male-threaded protrusion 40 thereon which, when the male threads 22 of the glass container 12 are screwed into the female threads 24 of the IV-bag 28, is screwed into a stopper cavity 42 of the stopper 18. Thus, it takes quite a bit of force to simultaneously screw the male threads 22 of the glass container 12 into the female threads 24 and the male-threaded protrusion 40 into the stopper 18 because of friction between these various parts. Once the medication vial 10 has been assembled with the IV-bag 28 by mating the male threads 22 with the female threads 24, the medication in the glass container 12 remains in the glass container separated from the carrier fluid in the IV-bag 28. Such assemblies are marked for particular patients for which they have been prepared and as to medications in the glass containers 12, and they are transported to the appropriate patients' rooms. When such an assembly is to be used by a nurse, she first compares the label thereon with a patient' s chart to ensure that it is the correct medication intended for the patient. She then manipulates walls of the flexible bag portion 30 of the IV-bag 28 to depress a tab 44 of the stopper remover 34. By manipulating this tab 44, the stopper remover 34 can be removed from the lower end 36 of the hard mouth portion 32 of the IV-bag 28, and when this is done, the male-threaded protrusion 40 carries the stopper 18, to which it is engaged, with it. The stopper remover 34 and the attached stopper 18 fall into the interior of the bag portion 30 of the IV-bag 28 and communication is then allowed between an interior of the glass container 12 and the interior of the bag portion 30 of the IV-bag 28. The entire assembly is then suspended from a support by means of a plastic loop 46 which is integral with the plastic coaster 14 on the medication vial 10. The medication from the glass container 12 of the medication vial and the carrier fluid from the IV-bag 28 are then mixed and administered via a lumen 48 into a patient. Turning now to the embodiment of the invention depicted in FIG. 2, a medication-vial hand tool 50 comprises a hand grip 52, an electric rotary motor 54, a clutch 56, a socket 58, and various controls, circuits and shafts for interconnecting these members. Looking more particularly at the socket 58 in relation to FIG. 1, the socket comprises a bowl-shaped shell 60, a resilient-material annularly-shaped lining 62, a hard-plastic retainer 64, and an attachment device 66. In this embodiment, the attachment device comprises a bolt 68, with a head 70, which is inserted from inside the shell 60 outwardly through an opening 72 at an attaching end 74 of the shell 60. Threads on the bolt 68 mate with a nut 76 outside the shell so that the attachment device 66 clamps a wall of the shell 60 between the head 70 and the nut 76. Thus, the attaching device 66 is held tightly on the shell 60 concentric with an axis 77 of the shell 60. An attachment key 78 protrudes outwardly, away from a mouth end 80 of the shell 60. The attachment key has a locking latch 82 thereon which engages with a linkage member (not shown) of the clutch 56 of the medication-vial tool 50. The resilient-material lining 62 is of a relatively soft rubber material and is formed in the annular shape of a tube, or hollow cylinder. In this regard, the resilient-material lining 62 is not adhered to the shell 60, but rather is held in a cavity 84 thereof by means of the annularly-shaped retainer 64 which has male threads thereon for screwing into female threads at a mouth 86 of the shell 60. The retainer 64 is of a relatively hard resinous plastic; in any event it is quite a bit harder than the resilient-material lining 62. A vial-receiving cavity 88 defined by the resilient-material lining 62 is of a size for snugly fitting an outer, radially-directed, surface 90 of the plastic coaster 14 of the medication vial 10. An interior surface 92 of the retainer 64 is slightly larger in diameter than the vial-receiving cavity 88 to allow easy entrance of the medication vial 10 into the interior of the socket 58; however, it should be sufficiently small, not much bigger than the outer diameter of the medication vial 10, so that it can guide the medication vial 10 into the snug cavity 88, holding it straight and aligned with the axis 77. In operation of the medication-vial tool 50, the attachment key 78 is engaged with a female coupling member (not shown) of the clutch 56 and is interlocked therewith by the locking latch 82 (or, in another embodiment, a set screw) so that the tool 50 is basically as shown in FIG. 2. A number of charged medication vials 10 are inserted into a medication-vial rack 94 upside down. The hand grip 52 is gripped by a user and the medication-vial tool 50 is manipulated so that a bottom-end portion 96 of a medication vial 10 is inserted through a guiding interior surface 92 of the retainer 64 into the vial-receiving cavity 88 of the resilient-material insert 62. In this respect, because the retainer is of a relatively hard material, the medication vial 10 is easily guided therethrough and placed in a relatively straight attitude, aligned with the axis 77, as it approaches and is inserted into the vial-receiving cavity 88 of the resilient-material insert 62. Thus, the medication vial 10 can be relatively easily placed into the vial-receiving cavity 88. Once the medication vial 10 is inserted into the vial-receiving cavity 88 a sufficient distance, radially-applied friction between the resilient-material lining 62 and an outer surface of the plastic coaster 14 is sufficient for holding the medication vial 10 in the socket 58 so that an operator can simply manipulate the hand grip 52 to lift the medication vial 10 with the medication-vial tool 50. The operator holds the hard mouth portion 32 of the IV-bag 28 in one hand (not shown) and the medication-vial tool 50 in the other hand (not shown) while bringing the male threads 22 of the glass container 12 into engagement with the female threads 24 of the hard mouth portion of the IV-bag 28. Once these threads are in engagement, the operator presses on a trigger 98 of the hand tool 50 to activate the electric rotary motor 54 to rotate the socket via the clutch 56 for rotating the medication vial 10 so as not only to engage the threads 22 and 24 but also to engage the male-threaded portion 40 of the stopper remover 34 with the stopper 18. The clutch 56 is calibrated such that once the medication vial 10 has been screwed onto the IV-bag 28 with sufficient torque, the clutch 56 no longer transmits rotary motion from the rotary motor 54 and the operator knows to release the trigger 98. The hand grip 52 and IV-bag 28 are then manipulated to pull the socket 58 off of the medication vial 10. The medication-vial tool 50 can be used in a similar manner for detaching a medication vial 10 from an IV-bag by making the rotary motor 54 to be reversible. In this regard, when vials are screwed to IV-bags by hand, as is done in the prior art, it is very difficult to unscrew them by hand. Because it is extremely important that the vials be absolutely sealed with the IV-bags, technicians tend to over-tighten them so as to be sure there is a good seal between them. Thus, when a mistake is made, and it becomes necessary to unscrew a vial from an IV-bag, technicians often have difficulty doing this and often damage the IV-bags in the process. Damaged IV-bags must be discarded. Similarly, technicians tend to over-tighten vials when they first begin to work, but tend to under-tighten them as they, the technicians, become tired. If vials are under-tightened, they may leak, in which case they also must be discarded. When combined vials and IV-bags must be discarded, it is quite expensive for hospitals. Not only do the hospitals lose the medicine, vials, and IV-bags involved, but also new, special, vial-IV-bag combinations must be prepared to replace the discarded ones, which involves time and effort. Another embodiment of this invention, and actually the preferred embodiment, is depicted in FIG. 4. In the FIG. 4 embodiment, the socket 58 is the same as the socket depicted in the FIGS. 1 and 2 embodiments, however, in the FIG. 4 embodiment, the socket 58 is attached to a shaft 100 of a table-mounted motor 102 by means of a set-screw sleeve 104. That is, in the FIG. 4 embodiment, there is no clutch between the socket 58 and the motor 102, but rather there is direct engagement therebetween. In the preferred embodiment, the mouth of the socket 10 is directed somewhat horizontally, although it is not necessary that it be directed precisely horizontally. A motor housing 107, containing the motor 102, is mounted on a table, or platform, 106 by means of rubber suction cups 108 and has a tubularly-shaped protective hood 110 affixed thereto for surrounding the rotating socket 58. In this regard, in the preferred embodiment, the socket 58, whose mouth is directed laterally, is continually rotated by the motor 102. The method of using the tool depicted in FIG. 4 involves attaching the motor housing 107 to the table 106 with the suction cups 108 and activating the electric motor 102 by means of a switch, which could be, for example, in an electric cord 112. The electric cord 112 can, of course, have various controls therein, such as on-off controls and power controls. Further, such controls could be in the motor housing 107. However, in general, the motor 102 is turned on to continually rotate the socket 58. While the socket 58 is rotated, a technician places a bottom end of a medication vial 10 into the socket 58, generally in the same manner as shown in FIG. 1. As the medication vial 10 is inserted into the socket 58, the technician can feel that the vial 10 is being gripped by the radially directed surface of the resilient-material insert 62 and that a rotating force is being applied to the vial. Once the technician believes that there is sufficient friction between the medication vial 10 and the resilient-material insert 62, the technician moves a hard mouth portion 32 of an IV-bag 28 so that female threads thereof engage male threads of the rotating medication vial 10. Since the technician is preventing the IV-bag from rotating, but the medication vial is being rotated by the socket 58, the male and the female threads will be quickly screwed together. Because the forces which are creating friction between the resilient-material insert 62 and the outer surface of the medication vial 10 are being applied radially, the technician can determine how much force is desired by inserting the medication vial to a greater or lesser extent into the socket 58, and this can be changed even during engagement of the male and female threads. In any case, once the medication vial 10 is fully screwed into the IV-bag 28, there will be slippage between the medication vial 10 and the resilient-material insert 62 so that a clutch is not needed to slow down rotation of the socket 58. The technician can easily feel when the medication vial is screwed into the IV-bag far enough and at this point pulls the IV-bag with the attached medication vial away from the socket 58 and repeats this process with another medication vial and IV-bag. It has been found that, with the FIG. 4 embodiment, as many as twenty vials can be screwed together with IV-bags in 20 seconds as opposed to requiring almost five minutes for this number when they are screwed in by hand. Further, it has been found that the vials can be screwed into the IV-bags in a more consistent manner, to achieve a more uniform final torque, than when this is done by hand. A uniform end torque is beneficial for ensuring that there is no leakage and for allowing possible unscrewing if necessary. The protective hood 110 protects the rotating socket 58 from coming into contact with loose material, such as ties and the like. While the invention has been particularly shown and described with reference to a preferred embodiment, it will be understood by those of ordinary skill in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention. The medication-vial tool 50 can be operated directly with an electric cord or it can include a rechargeable battery. Also, the hand tool 50 can be used without a clutch and so that the socket 58 is continually rotated. It would be possible to use many different attachment devices 82 and 104 to attach the bowl-shaped shell 60 of the socket 58 to a shaft of an electric rotary motor. In this regard, it is important that such an attachment be positive and strong, because the medication vials 10 are held rather tightly in the socket 58 and when the socket is pulled off of the vials 10, after they are attached to the IV-bags 28, it is undesirable that the sockets stay with the vials. It will be understood by those of ordinary skill in the art that this invention allows hospital technicians to screw medication vials into IV-bags much more quickly and easily than was possible in the prior art. Yet another benefit of this invention is that hospital personnel using the invention to assemble medication vials with IV-bags do not damage their bodies. That is, they can quickly assembly the medication vials with the IV-bags without increasing the risk of getting carpal tunnel syndrome. The fact that the resilient material insert 62 of the socket of this invention makes frictional contact with medication vials mainly at surfaces facing radially is a benefit, because with this structure rotational forces transmitted to the vials can be adjusted by inserting the vials to a greater or lesser degree. This feature also helps allow the system to function without a clutch between a motor and the socket. Another helpful structural feature of this invention is the hard plastic retainer 64 which not only holds the resilient material insert 62 in the shell 60, but also serves as a guide for medication vials, holding them straight as they are inserted into, and held in, the vial-receiving cavity 88 of the resilient-material insert 62. This member also can be used for applying pressure on the resilient-material insert so that it flexes inwardly to apply more pressure on vials radially. Such an adjustment can be used for compensating for wear of the resilient-material lining 62. Further, resilient-material inserts can easily be replaced simply by detaching the retainer 64 from the shell 60. It is beneficial that in one embodiment the socket is continually rotated as vials are inserted therein, screwed onto IV-bags and removed therefrom, because in this manner there is less wear on the motor, fewer manipulations are required by the operator, and the operation can be carried out faster. Another significant feature of this invention is the direction in which the mouth of the socket 58 is facing when the motor housing 107 is mounted on the horizontal platform 106. That is, the socket mouth is facing substantially horizontally. It is helpful to be able to load vials into the socket from the side, if not directly horizontally at least along a horizontal component. That is, it would be difficult for a technician to hold mouths of loaded IV-bags facing vertically downwardly when they are being screwed to vials, because the loads in bag portions 30 thereof would be unsupported. With this invention, the loaded IV-bags can be slid along the horizontal platform 106 while their mouths are mated with medicine vials. However, this invention can also be used in an embodiment in which vials are loaded vertically. Further, it would be possible to construct the resilient-material insert 62 so that it applies frictional forces axially on the bottom of the medication vial 10 rather than radially.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. provisional Application Ser. Nos. 60/361,989 filed 5 Mar. 2002 and 60/355,175 filed 7 Feb. 2002. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present application relates generally to the field of vehicular access systems for handicapped persons, and more particularly to the field of safety devices related to those systems. [0004] 2. Description of the Related Art [0005] People who have difficulty walking and people who use wheelchairs often have difficulty moving between different levels, such as getting into and out of vehicles. Consequently, there is a great need for devices that are capable of transporting people into and out of vehicles. Therefore, many different vehicular wheelchair access systems, such as lifts and ramps, have been developed to fulfill this need. These systems can be mounted on vehicles and manipulated between deployed and stowed positions with respect to the vehicle. When these systems are in the deployed position, wheelchair users typically must move their wheelchair along the lift and ramp platforms in order to transfer from the ground to the vehicle and from the vehicle to the ground. During the use of convention vehicle access systems, the passenger or operator can encounter potential dangers, such as falling off of the lift or ramp. Therefore, it is desirable to provide a safety system to assist lift operators and users in operating the access system in a safe manner. The invention of the present application is directed to satisfying these needs, among others. [0006] Many vehicle access systems such as passenger lifts and ramps are known in the art. However, there is a constant desire in the art to make these systems more reliable, cost effective and safe. Many safety features are currently used on several access systems, such as safety belts, barrier plates, and sensors. These restraining devices help prevent wheelchairs from rolling off the access system while in operation or can prevent operation of the access system altogether. However, they can have certain problems that can make them unsafe. [0007] Some vehicle access systems utilize belt buckle with an electronic safety interlock to prevent all movement of the access system until the safety belt is fastened to the buckle. In such devices, the safety interlock is a normally open electric switch located in the buckle. Thus, when the safety belt is unbuckled, the switch is open and the lift is incapable of operation. Once the safety belt is buckled, the switch is closed and the system is capable of operating. However, if the belt is unbuckled in the middle of operation, the system will stop operating. This can create a dangerous situation wherein the passenger is stuck in an elevated position in which the passenger cannot safely access either the vehicle or the ground. Furthermore, the passenger is stuck in this position, unrestrained by the safety belt. Thus, despite other safety features, the passenger may be able to roll off the access system while the system is in a position in which its is not safe to dismount. In such devices, operation of the system will not and cannot continue until the safety belt is buckled once again. [0008] In light of the problems and limitations described above, a need exists for a vehicle access system that is reliable, cost effective, and safe so that either safety restraint systems cannot be removed while in operation or that operation does not automatically cease between access positions even if the safety belt is removed during operation of the system. Each embodiment of the present invention achieves one or more of these results. SUMMARY OF THE INVENTION [0009] The vehicle access system according to some embodiments of the present invention has an electrical system, a motive source coupled to the electrical system, an arm coupled to the motive source, a platform coupled to the arm, and a safety restraint system coupled to the electrical system and the platform. The vehicle access system can be mounted to the vehicle and operable to move a passenger between the ground and the vehicle. If the vehicle access system is mounted to the vehicle, it can have three or more main positions and numerous intermediate positions. The main positions can include a stowed position, vehicle access position (loading/unloading position into and out of the vehicle), and a ground access position (loading/unloading position onto and off of the ground). Thus, the passenger can safely access the platform at either access position. Once the passenger is situated and restrained on the platform, the platform can be moved between levels and the passenger can safely dismount the platform at the other access position. The platform, however, is unable to move from either access position until the safety restraint system is in place. [0010] Some embodiments of the present invention utilize a belt and buckle that has a current path through it as part of a safety restraint system. The current path is open when the belt and buckle are unbuckled and closed when they are buckled. The current path through the safety belt, in some embodiments, is coupled to a silicon controlled rectifier diode that is coupled to the electrical system of motive source. The diode has a turned-on and a turned-off state. The motive source can be powered when the diode is turned-on and cannot be powered when the diode has been turned-off. The diode is turned-on and off by a gate coupled to the current path in the buckle. When the current path through the buckle is closed, current flows to the gate of the diode to turn-on the diode and allow current to flow to the motive source. Once the diode is turned-on and so long as current continues to be drawn to the motive source, the diode can remain turned-on regardless of the state of the current path through the buckle. Thus, once operation of the access system has begun, it can continue to operate and move the passenger to one of the safe access positions even if the buckle is subsequently released. [0011] Other embodiments of the present invention can utilize one or more additional safety features alone or in combination with the above mentioned features. For example, some embodiments utilize roll-stops coupled to the platform, while other embodiments utilize a lock on the safety belt to prevent unbuckling during operation to prevent the passenger from rolling off the platform. Yet other embodiments utilize various audible and/or visual signals to alert the operator that the safety belt is unbuckled. Finally, other embodiments can utilize pressure switches coupled to the platform to prevent movement of the platform to the stowed position while the passenger is on the platform. [0012] A better understanding of the principles of the invention will become apparent from the following detailed description of the illustrated embodiments of the invention when taken in conjunction with the accompanying drawings, wherein like elements have like numerals throughout the drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The present invention is further described with reference to the accompanying drawings, which show preferred embodiments of the present invention. However, it should be noted that the invention as disclosed in the accompanying drawings is illustrated by way of example only. The various elements and combinations of elements described below and illustrated in the drawings can be arranged and organized differently to result in embodiments which are still within the spirit and scope of the present invention. [0014] In the drawings, wherein like reference numeral indicate like parts: [0015] FIG. 1 is a perspective view of a vehicular wheelchair access and safety belt system with the platform unfolded and extending from the vehicle in a horizontal entry level position and the safety belt engaged; [0016] FIG. 2 is a perspective view of the system of FIG. 1 with the platform at the ground level position and the safety belt engaged; [0017] FIG. 3 is a perspective view of the system of FIG. 1 with the platform folded to a vertically stowed position and the safety belt engaged; [0018] FIG. 4 is an electrical schematic including for the wheelchair access system including the safety belt system of the present invention; and [0019] FIG. 5 is one embodiment of a wiring diagram for the electrical system of FIG. 4 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0020] For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any such alterations and further modifications in the illustrated embodiments, and such further applications of the principles of the invention as illustrated herein are contemplated as would normally occur to one skilled in the art to which the invention relates. [0021] Referring now to FIG. 1 there is illustrated a vehicular access system 10 . Although access system 10 is illustrated as a wheelchair lift type system, it is also contemplated that principles discussed herein have application in wheelchair ramp type systems. Access system 10 is mounted in the door of a vehicle (not shown) to provide wheelchair passenger access to and from the vehicle. Access system 10 has a platform 22 movable in the inboard and outboard directions relative to the vehicle, as indicated by arrow I (inboard direction) and arrow 0 (outboard direction.) Examples of wheelchair access systems are provided in U.S. Pat. No. 6,238,169; U.S. Pat. No. 5,806,632; U.S. Pat. No. 5,261,779; U.S. Pat. No. 6,065,924; and U.S. Provisional Application Ser. No. 60/355,175 filed Feb. 7, 2002, each of which is incorporated herein by reference in its entirety. Another example of a wheelchair access system is The Braun Corporation's EV BRAUN ENTERVAN® wheelchair access ramp. [0022] In the illustrated embodiment, access system 10 includes a motive source 12 operatively coupled to paired parallelogram type lifting mechanisms 14 . Parallelogram lifting mechanisms 14 include vertical arms 20 to which an inboard end of platform 22 is pivotally coupled. When not in use, it is desirable to stow platform 22 in the vehicle in a vertical orientation adjacent the door of the vehicle to minimize its intrusion into the vehicle. Platform 22 can also be provided with foldable sections for stowage in a reduced height configuration, such as described in the aforementioned Provisional Application No. 60/355,175 filed Feb. 7, 2002. [0023] Access system 10 also includes articulated lever assemblies 16 pivotally connected to the inboard end of platform 22 at one end and to a corresponding one of the vertical arms 20 at their other end. Articulated lever assemblies 16 can include a longer arm pivotally connected to a shorter arm at a common center along with a saddle block for contacting the bottom arm of parallelogram lifting mechanisms 14 , such as shown and described in the aforementioned U.S. Pat. No. 6,238,169 and Provisional Application No. 60/355,175 filed Feb. 7, 2002. A safety shield 18 extends from a corresponding one of the vertical arms 20 along each side of articulated lever assemblies 16 to protect against the potential placement of a part of a person or object therebetween before and/or during lift operation. [0024] Motive source 12 is operable to swing lifting mechanisms 14 generally along path R to move platform 22 from the vertically stowed position of FIG. 3 , to the transfer level position or horizontal entry level position of FIG. 1 , to the ground level position of FIG. 2 , and back. Motive source 12 can be electrically coupled to the vehicle power source and include hydraulic pumps and/or electrical motors and other components to accomplish the desired movement for lifting mechanisms 14 . [0025] Mounting members 93 are secured to a floor plate 56 of the vehicle. Lifting mechanisms 14 are pivotally mounted to a corresponding one of mounting members 93 . Each lifting mechanism 14 includes an upper arm 88 and a lower arm 90 . Upper arms 88 are each pivotally coupled at their inboard end to a corresponding one of the mounting members 93 . Lower arms 90 are also each pivotally coupled at their inboard end to a corresponding one of the mounting members 93 below upper arm 88 . Each lifting mechanism 14 also includes a cylinder 92 pivotally coupled at its outboard end to lower arm 90 and also to vertical arm 20 . The inboard end of each cylinder 92 is pivotally coupled to the inboard end of the respective upper arm 88 at mounting member 93 . A deploy assist mechanism 86 can be provided around each cylinder 92 . Further details regarding cylinder 92 and deploy assist mechanism 86 are provided in the aforementioned Provisional Application 60/355,175 filed Feb. 7, 2002. [0026] When platform 22 is in its vertically stowed position, there may be a tendency for platform 22 to drift in the outboard direction due to, for example, a slow loss of hydraulic pressure in cylinder 92 . When the platform drifts, it could push against the vehicle door, making opening of the door difficult and also damaging the interior of the vehicle. Thus, there is provided anti-drift mechanism 100 . One embodiment of anti-drift mechanism 100 is shown in the aforementioned Provisional Application No. 60/355,175 filed Feb. 7, 2002. Other embodiment anti-drift mechanisms are provided in U.S. patent application Ser. No. 09/702,397 filed on Oct. 31, 2000, which is incorporated herein by reference. [0027] Platform 22 is pivotally coupled at its inboard end to each of the vertical arms 20 . Platform 22 has side barriers 28 extending along each side thereof. Platform 22 can be provided with meshed grid-like or solid plate-like transfer surface between the side barriers and between the inboard/outboard ends of platform 22 . [0028] Access system 10 also includes a spring-loaded rollstop 46 pivotally connected to the outboard end of platform 22 that is normally spring-biased to a raised safety barrier position as shown in FIG. 1 . Rollstop 46 includes feet 46 a , 46 b ( FIG. 1 ) that contact the ground to move rollstop 46 to lower rollstop 46 to transfer level position extending from the outboard end of platform 22 as shown in FIG. 3 . [0029] Access system 10 includes a bridge plate 50 pivotally coupled to the inboard end of platform 22 . A pair of actuator assemblies can be provided to couple bridge plate 50 to each of the articulated lever assemblies 16 . The actuator assemblies and articulated lever assemblies 16 operate in concert such that contact between articulated lever assemblies 16 and bottom arms 90 of lifting mechanisms 14 variously raise and lower bridge plate 50 between a raised safety barrier position ( FIG. 2 ) and a generally horizontal transfer level position ( FIG. 1 .) Further details regarding bridge plate 50 are provided in the aforementioned Provisional Application 60/355,175 filed Feb. 7, 2002 and also in U.S. Pat. No. 6,238,169. Other mechanisms for raising and lowering bridge plate 50 are also contemplated. [0030] Access system 10 further includes handrails 42 extending horizontally from vertical arms 20 when platform 22 is deployed in a horizontal position as shown in FIGS. 1 and 2 . When folded, as shown in FIG. 3 , handrails 42 each extend along a corresponding one of the vertical arms 20 . A bumper 78 can be coupled to the upper side of each handrail 42 to eliminate or reduce noise and abrasion when the handrail is positioned against vertical arm 20 . Each handrail 42 further includes an outboard end bent to conform to the upper end of vertical arm 20 when folded thereagainst. A grip handle can be placed over the outboard ends of each handrail 42 to facilitate gripping thereof. [0031] A safety belt system 200 is provided with access system 10 . System 200 includes a safety belt 202 extending between handrails 42 . Safety belt 202 is mounted at one end to one of the handrails 42 and removably engaged to a buckle 204 , which is mounted on the other handrail 42 . It is contemplated that safety belt 202 can include a strap and end member like that of an automobile seat belt for engagement with buckle 204 . Other configurations are also contemplated, so long as safety belt 202 is removably engageable with buckle 204 . Safety belt 202 can be non-retractable, although a retractable belt is also contemplated. Buckle 204 can have any configuration suitable for engagement with the end member of safety belt 202 . Buckle 204 includes a current path therein that is coupled with the electrical system 210 of motive source 12 by, for example, electrical wiring 206 . It is contemplated the current path in buckle 204 is normally open, and is closeable upon engagement of the end member of safety belt 202 with buckle 204 . Closing the current path in buckle 204 enables electrical system 210 to provide power to move platform 22 with motive source 12 . [0032] Platform 22 has three main positions including the vertically stowed position ( FIG. 3 ), the horizontal transfer level position ( FIG. 1 ), and the ground level position ( FIG. 2 .) Access system 10 includes sensors providing signals to electrical system 210 indicating when the platform is at one of the three main positions. The platform position signals from platform sensors for the stowed position and the floor level position may be used to stop platform movement when the desired position is reached. [0033] When the current path in buckle 204 is closed by engaging the end member of belt 202 to buckle 204 , electrical system 210 can provide power to motive source 12 to move platform 22 between the three main positions with lifting mechanisms 14 based on operator signal input indicating the desired platform movement. When safety belt 202 is not coupled with buckle 204 , the current path of electrical system 210 in buckle 204 is open and platform movement cannot be initiated by operator input signals. [0034] The safety belt system of the present invention enhances operator control of the lift during platform movement. If the current path in buckle 204 is closed with the end member of safety belt 202 , and platform movement has been initiated by operator signal inputs, and the current path in buckle 204 is thereafter opened during platform movement by disengaging the end member of belt 202 , the current path in electrical system 210 is maintained for platform movement to one of the three main positions. However, platform movement can be stopped at any position intermediate the three main positions by the operator. Thus, the operator maintains control over lift operation even if safety belt 202 is unbuckled. [0035] When safety belt 202 is unbuckled, and when platform is at one of the three main positions or has been stopped by the operator at an intermediate position, the current path of electrical system 210 is open to prevent platform movement. Platform movement can continue when the end member of belt 202 is engaged to buckle 204 to close the current path in buckle 204 . [0036] In FIG. 4 , there is shown an electrical schematic of one embodiment of electrical system 210 for providing power to move platform 22 . In FIG. 5 there is shown one embodiment of a wiring diagram for electrical system 210 of FIG. 4 . Electrical system 210 is electrically coupled to safety belt system 200 . In the illustrated embodiment, electrical system 210 includes an operator input device 212 electrically coupled to a microswitch station 214 . It is contemplated that input device 212 could also employ infrared or radio signals to communicate input signals from the operator. It is further contemplated that a programmable controller could be provided in lieu of or in addition to microswitches 214 . Electrical system 210 further includes a power source 218 . It is contemplated that power source 218 can be the vehicle's main battery or backup battery, or a stand-alone battery dedicated to electrical system 210 . Input device 212 , microswitches 214 and power source 218 are electrically coupled to a pump housing 215 . [0037] Pump housing 215 includes a drive means 220 , an up/fold controller 222 , a down controller 224 and an unfold controller 226 . In the illustrated embodiment, controller 222 is a controller which controls operation of drive means 220 , and controllers 224 and 226 are solenoids that control operation of valves of a hydraulic system coupled between drive means 220 and cylinder 92 . Drive means 220 includes a hydraulic pump and motor to supply hydraulic pressure to cylinders 92 to raise platform 22 from the ‘ground level position to the entry level position, and also to vertically fold platform 22 from the entry level position. An interlock 228 is provided to allow coupling of additional sensors and the like to electrical system 210 . For example, a sensor can be mounted on the vehicle door and coupled to electrical system 210 via interlock 228 . Control of the operation of platform 22 can be based on satisfaction of an external condition determined by the sensor, such as whether the vehicle door is completely open. [0038] Safety belt system 200 is electrically coupled between power source 218 and pump housing 215 to control the operation of drive means 220 . In the illustrated embodiment, safety belt system 200 includes a safety belt switch 230 in buckle 204 , a current flow control device 232 in the form of an SCR diode, and a resistor 234 . Current flow control device 232 includes gate G that prevents current flow therethrough when the current path in buckle 204 is open. When the current path in buckle 204 is open, current flow control device 232 disables electrical system 210 by blocking the current path to operate drive means 220 and controllers 222 , 224 , and 226 with operator input signals from input device 212 . [0039] When the current path in buckle 204 is closed, current from power source 218 flows through resistor 234 and switch 230 to energize and open gate G of current flow control device 232 . With gate G open, current can flow through current flow restrictor 232 , and power is provided from power source 218 to operate controllers 222 , 224 and 226 based on operator input signals from signal input device 212 . Such signals initiate folding or unfolding of platform 22 between the vertically stowed and horizontal entry level positions, and the moving platform 22 up or down between the horizontal entry level and ground level positions. If the current path in buckle 204 is opened by unbuckling belt 202 from buckle 204 , gate G remains opened until one of the platform positions is sensed at either stowed or floor level position or until platform operation is stopped by the operator. However, once one of the main positions of platform 22 is sensed or platform movement is stopped by the operator through signal input device 212 , power cannot be supplied to drive means 220 and controllers 222 , 224 , 226 until the circuit in buckle 204 is closed by engaging belt 202 to buckle 204 . [0040] In the illustrated embodiment, signal input device 212 includes an unfold input and a fold input selectable by the operator to provide signals indicative of the desired platform movement from the vertically stowed position to the horizontal transfer level position and back, respectively. Signal input device 212 also includes a down input and an up input selectable by the operator to provide signals indicative of the desired platform movement from the horizontal entry level position and the ground level position and back, respectively. [0041] It is contemplated that microswitch station 214 includes unfold/down microswitches and up/fold microswitches coupled to controllers 222 , 224 , 226 to control platform 22 movement in accordance with the commands received from signal input device 212 as selected by the operator. In the illustrated embodiment, the up/fold microswitch signals the up/fold controller 222 to start or stop drive means 220 . The unfold/down microswitch signals down controller 224 to open and close a first valve in the hydraulic system, and also signals unfold controller 226 to open and close a second valve in the hydraulic system. [0042] In operation, when the up input is selected by the operator and safety belt 202 is engaged to buckle 204 , controller 222 starts drive means 220 wherein the hydraulic pump provides pressurized hydraulic fluid to cylinder 92 to move platform 22 from the ground level position to the horizontal entry level position. Belt 202 can be disengaged from buckle 204 during this movement without affecting platform movement to the entry level position. When the platform reaches the entry level position sensors provide a signal to direct controller 222 to stop drive means 220 . [0043] When the fold input is selected by the operator and safety belt 202 is engaged to buckle 204 , controller 222 starts drive means 220 to provide pressurized hydraulic fluid to cylinder 92 to move platform 22 from the horizontal entry level position to the vertically stowed position. Belt 202 can be disengaged from buckle 204 during this movement without affecting platform movement to the vertically stowed position. When the platform reaches the vertically stowed position sensors provide a signal to direct controller 222 to stop operation of drive means 220 . [0044] When platform 22 is in the vertically folded position and safety belt 202 is engaged to buckle 204 , operator selection of the unfold input signals down controller 224 to open the first valve in the hydraulic system and also signals unfold controller 226 to open the second valve in the hydraulic system. Belt 202 can thereafter be disengaged from buckle 204 without affecting platform movement to the entry level position. Unfolding of platform 22 is controlled by directing the hydraulic fluid through the second valve, which includes or is in fluid communication with a restricted orifice. The restricted orifice causes the pressure to be relieved more slowly than would result if only the first valve were opened, thus' slowing movement of platform 22 from the vertically stowed position to the horizontal entry level position. When the platform reaches the entry level position sensors provide a signal to direct controllers 224 , 226 to shut the first valve and the second valve. [0045] When platform 22 is at the horizontal entry level position and safety belt 202 is engaged to buckle 204 , a down input from the operator signals down controller 224 to open the first valve to relieve hydraulic pressure from cylinder 92 to allow platform movement from the horizontal entry level position to the ground level position. Belt 202 can be disengaged from buckle 204 during this movement without affecting platform movement to the ground level position. There is no ground level sensor. See note on page 8. [0046] In one alternate embodiment, electrical system 210 does not include an unfold controller 226 coupled to a restricted orifice, but rather only a down controller 224 to open the first valve to relieve pressure from cylinder 92 . Hydraulic pressure is relieved through this first valve for platform movement both from the vertically stowed position to the entry level position, and from the entry level position to the ground level position. In such an alternate embodiment, the restricted orifice is not needed since controller 224 and the first valve coupled thereto allow platform 22 to unfold from the vertically stowed position at a rate within a desired range. Factors that influence whether the unfold rate of movement of platform 22 can be maintained in the desired range using only controller 224 and the first valve include the size of platform, the rates at which the desired range is established, and whether the first valve can be modulated for varying flow rates therethrough. Another factor is whether platform 22 is folded to a reduced height configuration when vertically stowed such as described in the aforementioned Provisional Application 60/355,175 filed Feb. 7, 2002. If platform 22 is provided as described therein, then only a single down controller 224 is needed since the reduced height, folded platform will unfold from the vertical position at a slower rate than if the platform were not folded to a reduced height configuration. [0047] Referring back to the illustrated embodiment, it is contemplated that the microswitches or other controller means can be configured so that with platform 22 in the entry level position signals from the unfold input and the up inputs of signal input device 212 are ignored or disabled. In the ground level position, signals from the fold input, unfold input and down input of signal input device 212 are ignored or disabled. In the vertically stowed position, signals from the fold input, down input and up input of signal input device 212 are ignored or disabled. [0048] From the horizontal entry level position, the operator can then either fold the platform to the vertically stowed position or again move the platform to the ground level position as discussed above. When platform 22 is at the horizontal entry level position, a wheelchair passenger can be positioned on platform 22 from the vehicle. Pressure switch 216 thereafter prevents movement of platform 22 from the horizontal entry level position to the vertically stowed position if the fold input is selected. Selection of the down input moves platform 22 from the horizontal entry level position to the ground level position where the wheelchair passenger exits the lift. Another wheelchair passenger may then board the lift, and platform 22 raised from the ground level position to the entry level position by selecting the up input. The wheelchair passenger on platform 22 can then enter the vehicle. Again, pressure switch 216 prevents platform 22 from being moved from the horizontal entry level position to the vertically stowed position until the wheelchair is off of platform 22 . When platform 22 is clear of passengers, the fold input can be selected to move platform 22 to the vertically stowed position. Further examples and discussion regarding pressure switch 216 are provided in U.S. patent application Ser. No. 09/430,436 which is incorporated herein by reference in its entirety. [0049] It is also contemplated that the fold and unfold inputs of signal input device can be integrated into a single input, and that the up and down inputs can be integrated into a single input. The single unfold/fold input would unfold the platform if the platform is determined to be in a folded condition, and fold the platform if the platform is determined to be at horizontal transfer level position. Activation of the single up/down input will lower the platform if the platform is determined to be in a horizontal entry level position, and raise the platform if the platform is determined to be at the ground level position. Platform movement can be stopped and reversed by providing a second input after initial movement has been initiated. [0050] It is contemplated that the fold and unfold inputs and up and down inputs on signal input device 212 can be momentary contact switches that require the operator to hold the switch closed for platform movement to a desired position. If the operator releases the switch, then platform movement stops immediately. When the switch is again activated, platform operation continues toward the desired position so long as the operator maintains the switch closed. [0051] It is also contemplated that the fold and unfold inputs and the up and down inputs on the input control device can be continuous contact switches that require the operator to activate the switch for platform movement. If the operator releases the switch, platform movement continues to the appropriate vertically stowed, horizontal entry level or ground level position unless the switch is reactivated or a stop signal is received. [0052] A further embodiment of safety belt system 200 contemplates providing an alarm to signal disengagement of safety belt 202 from buckle 204 . The alarm could be an audio signal and/or visual signal to the operator. The alarm would notify the operator that safety belt 202 is unbuckled so that the operator can take an appropriate action. For example, upon indication that safety belt 202 is unbuckled, the operator may want to immediately stop platform movement by providing the appropriate signal through signal input device 212 . For embodiments in which input device includes momentary contact switches, the operator could simply release the switch to stop platform movement intermediate one of the main positions. In another example, the operator may desire that platform movement continue to one of the main positions. For embodiments in which input device includes momentary contact switches, the operator could simply maintain the switch in the closed position to continue platform movement to the next main position. [0053] A further embodiment of safety belt system 200 includes a safety belt locling system that prevents unbuckling of safety belt 202 from buckle 204 during platform movement. Such an interlock device would receive a signal from electrical system 210 that platform movement has been initiated, and would thereupon lock safety belt 202 to buckle 204 . Once platform movement has stopped by reaching one of the main positions, or has been stopped by the operator, safety belt 202 would automatically unlock from buckle 204 , and could thereafter be unbuckled. [0054] While the invention 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 embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.

1a

CROSS-REFERENCES TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 60/229,616, filed Aug. 31, 2001, which is hereby incorporated by reference herein. BACKGROUND OF THE INVENTION The present invention relates to oximetry sensors and, in particular, pulse oximetry sensors which include coded information relating to characteristics of the sensor. Pulse oximetry is typically used to measure various blood flow characteristics including, but not limited to, the blood-oxygen saturation of hemoglobin in arterial blood, the volume of individual blood pulsations supplying the tissue, and the rate of blood pulsations corresponding to each heartbeat of a patient. Measurement of these characteristics has been accomplished by use of a non-invasive sensor which passes light through a portion of the patient's tissue where blood perfuses the tissue, and photoelectrically senses the absorption of light in such tissue. The amount of light absorbed is then used to calculate the amount of blood constituent being measured. The light passed through the tissue is selected to be of one or more wavelengths that are absorbed by the blood in an amount representative of the amount of the blood constituent present in the blood. The amount of transmitted light passed through the tissue will vary in accordance with the changing amount of blood constituent in the tissue and the related light absorption. For measuring blood oxygen level, such sensors have been provided with light sources and photodetectors that are adapted to operate at two different wavelengths, in accordance with known techniques for measuring blood oxygen saturation. An encoding mechanism is shown in U.S. Pat. No. 4,700,708, the disclosure of which is incorporated herein by reference. This mechanism relates to an optical oximeter probe which uses a pair of light emitting diodes (LEDs) to direct light through blood-perfused tissue, with a detector picking up light which has not been absorbed by the tissue. The operation depends upon knowing the wavelength of the LEDs. Since the wavelength of LEDs can vary, a coding resistor is placed in the probe with the value of the resistor corresponding to the actual wavelength of at least one of the LEDs. When the oximeter instrument is turned on, it first applies a current to the coding resistor and measures the voltage to determine the value of the resistor and thus the value of the wavelength of the LED in the probe. U.S. Pat. No. 5,259,381 recognizes that the coded value of the wavelength of the red LED provided by a coding resistor may be inaccurate, since the actual wavelength can vary with temperature. Accordingly, this patent teaches including a temperature sensor in the oximeter probe to measure the actual temperature. With the actual temperature, and the coded wavelength value, a look-up table can be consulted to determine the actual LED wavelength for that temperature. Another method of storing coded information regarding the characteristics of the LEDs is shown in U.S. Pat. No. 4,942,877 assigned to Minolta. This patent discloses using an EPROM memory to store digital information, which can be provided in parallel or serially from the sensor probe to the remote oximeter. The memory is described as storing coefficients for the saturation equation, wavelength, subwavelength (where 2 peaks for LED), half-width of wavelength spectrum emitted by LED, intensity of LEDS or ratio, and on time of LEDS (written by the processor). Other examples of coding probe characteristics exist in other areas. Multiple calibration values are sometimes required, with this making the circuitry more complex or requiring many leads. In U.S. Pat. No. 4,446,715, assigned to Camino Laboratories, Inc., a number of resistors are used to provide coded information regarding the characteristics of a pressure transducer. U.S. Pat. No. 3,790,910 discloses another pressure transducer with a ROM storing characteristics of the individual transducer. U.S. Pat. No. 4,303,984 shows another probe with digital characterization information stored in a PROM, which is read serially using a shift register. Typically, the coding element is mounted in the probe itself. For instance, U.S. Pat. No. 4,621,643 shows the coding resistor mounted in the probe element itself. In addition, U.S. Pat. No. 5,246,003 shows the coding resistor being formed with a printed conductive material on the probe itself. In some devices, an electrical connector coupled by a cable to a device attached to a patient may include a coding element. For example, U.S. Pat. No. 3,720,199 shows an intra-aortic balloon catheter with a connector between the catheter and a console. The connector includes a resistor with a value chosen to reflect the volumetric displacement of the particular balloon. U.S. Pat. No. 4,684,245 discloses a fiberoptic catheter with a module between the fiberoptic and electrical wires connected to a processor. The module converts the light signals into electrical signals, and includes a memory storing calibration signals so the module and catheter can be disconnected from the processor and used with a different processor without requiring a recalibration. U.S. Pat. No. 5,645,059 teaches using a modulated signal to provide the coded data to a remote analyzer. U.S. Pat. No. 5,429,129 shows using a voltage regulator to produce a specific voltage value in response to an attempt to read by the analyzer. Hewlett-Packard Company U.S. Pat. No. 5,058,588 teaches an oximeter sensor with an encoding element that could be resistor, ROM, or customized integrated circuit. The encoding element encodes the type of sensor (in particular, type indicating area of placement on body—finger, ear, foot, arm; also, the type of sensor can indicate transmission/reflection type, or adult/neonate {indicating correction to be performed on theoretical oxygen saturation, allow switching between physiological limits such as minimum/maximum pulse rates for adults/neonates}; the maximum driving current may be adapted according to type of sensor, and contact of sensor with tissue can be tested by means of an attenuation measurement if sensor type is known). Nellcor U.S. Pat. No. 5,645,059, the disclosure of which is hereby incorporated herein by reference, teaches coding information in sensor memory used to provide pulse modulated signal, to indicate the type of sensor (finger, nose), the wavelength of a second LED, the number of LEDs, the numerical correction terms to the standard curves, and an identifier of the manufacturer. A number of catheter patents also discuss encoding information in the catheter. Sentron U.S. Pat. No. 4,858,615 teaches encoding the type of sensor, type number, serial number, date of production, safe use life of the sensor, correction data for non-linearity, pressure sensitivity, offset, and temperature sensitivity. Interflo Medical Published PCT Application No. PCT/US92/08263, Publication No. WO 93/06776 teaches encoding patient specific data, size, manufacture date, batch number, sterilization date, expiration date, transducer number and type, manufacturer's name and address, thermistor heating element resistance, filament efficiency, program segments or patient historical data., format version for the calibration data, trademark information, catheter unique serial number, ship date, other date and time information, security code to identify manufacturer, thermal mass, filament composition, coefficient of resistance, layout byte, checksum, copyright, number of seconds since a certain date, patient weight, patient height, timestamp of 1st CO data point, and a count of all CO data points in EEPROM. Dulex-Ohmeda of Boulder, Col. markets an oximeter sensor product that encodes data into resistor values representing pointers to a lookup table containing coefficients (as in U.S. Pat. No. 4,700,708) as well as indicating a range of LED drive current to use with the sensor. The LEDs are driven with a higher or lower drive currents depending upon the value of the resistor in a particular sensor. Honeywell U.S. Pat. No. 4,303,984 (expires Dec. 14, 1999) describes a memory which stores characterization information, such as linearization information for a pressure sensor. Alnor Instrument U.S. Pat. No. 5,162,725 describes storing both calibration and ID information in a sensor memory. Seimans U.S. Pat. No. 5,016,198 describes a coding memory in a sensor with data for defining sensor's characteristic curve. McBean U.S. Pat. No. 5,365,462 describes a date code in a sensor memory. Honeywell U.S. Pat. No. 4,734,873 describes a pressure sensor with a PROM storing coefficients for a polynomial. Robert Bosch U.S. Pat. No. 4,845,649 describes a PROM in a sensor storing correcting data. McBean U.S. Pat. No. 5,371,128 relates to EEPROM in sensor with sensor type code and calibration data. McBean U.S. Pat. No. 5,347,476 describes an accuracy code. Otax U.S. Pat. No. 5,528,519 shows a PROM in a connector for oximeter. Square D Company U.S. Pat. No. 5,070,732 shows calibration data in a sensor memory. Baxter U.S. Pat. No. 5,720,293 talks about different calibration information for a catheter, including a security code (encryption is discussed), serial number, model number, ID data such as calibration, manufacture, sterilization and ship date or other date and time information, a software program segment, security code for identifying whether sensor made by same manufacturer as monitor manufacturer, filament or transducer resistance, heat transfer coefficient, thermal mass, filament composition and coefficient of resistance, layout byte, copyright notice, checksum, random data bytes. Porsche U.S. Pat. No. 5,008,843 describes a sensor with EEPROM ID and characteristics data. BRIEF SUMMARY OF THE INVENTION The present invention provides a memory chip for use in an oximeter sensor, or an associated adapter or connector circuit. The memory chip allows the storing of different data to provide enhanced capabilities for the oximeter sensor. In addition to providing unique data to store in such a memory, the invention describes unique uses of data stored in such a memory. The data stored in the memory chip includes information relating to enhancing the performance of the oximetry system. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram of a pulse oximeter system in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 is a block diagram of a pulse oximeter system incorporating a calibration memory element 56 according to the invention. In one embodiment, memory element 56 is a two-lead semiconductor digital memory chip. The calibration element is part of the sensor 50 which also includes red and infrared LEDs 52 as in the prior art, along with a detector 54 . If desired, LEDs 52 may be replaced with other light emitting elements such as lasers. The oximeter includes read circuit 60 , drive circuit 66 , look-up tables 62 and 63 , controller 64 , amplifier 72 , filter 74 , and analog-to-digital converter 76 . Read circuit 60 is provided for reading multiple coded values across the two leads 51 , 53 connected to calibration element 56 . One value is provided to a look-up table 62 to determine appropriate wavelength dependent coefficients for the oxygen saturation calculation, as in the prior art. The other value(s) are then provided to another look up table(s) 63 which provides input (e.g., coefficients) to other calculations performed by controller 64 . These additional calculations may enhance the performance and/or safety of the system. Controller 64 provides signals to a drive circuit 66 , to control the amount of drive current provided to LEDs 52 . Memory 56 may, for example, be implemented as a random access memory (RAM), a FLASH memory, a programmable read only memory (PROM), an electrically erasable PROM, a similar programmable and/or erasable memory, any kind of erasable memory, a write once memory, or other memory technologies capable of write operations. As in the prior art, detector 54 is connected through an amplifier 72 and a filter 74 to an A/D converter 76 . This forms a feedback path used by controller 64 to adjust the drive current to optimize the intensity range of the signal received. For proper operation the signal must be within the analog range of the circuits employed. The signal should also be well within the range of A/D converter 76 (e.g., one rule that may be applied is to adjust LED drives and amplifier gains so that both red and IR signals fall between 40% and 80% of full scale reading of converter 76 ). This requires correct and independent settings for both the red and infrared LEDs. Numerous types of data can be stored in memory chip 56 . Some of these types of data are now discussed. Temperature at Which to Switch to Motion-Signal Algorithm The motion-signal algorithm here refers to the sensors designed to be used where “motion provides the signal”, i.e., the cardiac pulse need not be present or discernible in order for the oximeter to provide SP 0 2 values. Instead, the red and IR waveforms resulting from the motion itself are used for determining the arterial saturation (see e.g., U.S. Pat. No. 6,018,673). This feature is possible for tissue beds that are well “arterialized” (a large supply of arterial blood relative to the metabolic needs of the tissue) resulting in a small aterio-venous saturation difference, as well as other signal characteristics that are not germane to this discussion. We have observed that the necessary degree of arterialization correlates well to being “well perfused” at the tissue site, which itself correlates well to the tissue bed being warm. Thus by monitoring the temperature of the skin at the sensor site, and by knowing a value of temperature (programmed into the memory chip) at which the “motion-signal ” algorithm can be utilized for the specific sensor design being used, improved reading accuracy through motion can be better accomplished. Information on Use of Pins Chemical Sensor for EtO Cycles An electro-chemical or thermal device that senses and stores to memory the number of exposures (zero, once, or potentially more than once or the actual number) to sterilization cycles could be used to capture the history of the sensor. Excessive exposure to sterilization cycles degrades a number of components in the sensor, and can affect its performance. A sensor exceeding a certain number of exposures could cause a display to indicate the sensor needs to be replaced. Changeable Key Data encryption utilizes private and/or public keys to scramble the data written to the memory chip and later decipher the data so that only authorized devices are supported. To further prevent the use with a monitor that isn't certified to provide correct results, the sensor manufacturing system could periodically change the private and/or public keys. The change in the key could be communicated to the instrument via the memory chip in encrypted form. The purpose of this feature is to elevate the level of security in the memory system. Accelerometer on Chip This might be used in a scheme in which the memory chip was on the bandage, not in the connector. This combines a MEMS accelerometer with any of several different chips that might usefully be placed in the sensor head; local digitizing chip, preamp chip, memory chip. Accelerometer data may be used to warn of the presence of motion (in which case special algorithms may be called into play or oximetry may be suspended), or actually to help correct for motion (to the extent to which we can produce algorithms which can predict physio-optic effects of known motion). Optical Shunt The amount of optical shunting could be measured for each sensor, or family of sensors. The value would be stored in the sensory memory for the monitor to read and use to adjust the processing coefficients. Monitor Ambient Temperature This might be used, e.g., in overseeing the operation of an actively warmed sensor (i.e., a sensor provided with a low-power heating or warming surface). There is preferably a thermal cutout in the control system of actively warmed sensors, that causes operation to terminate if the sensor goes over a certain temperature. This is a necessary component of protecting the patient against burns. If the reason for a high sensor temperature is that the environment is warm, it could be quite acceptable to continue oximetry, even though warmer operation would be shut down. In the absence of knowledge about environmental temperature, a high temperature reading might have to be assumed to mean that something was wrong with the sensor, in which case ALL operation might have to cease. An environmental temperature sensor in the plug could help to tell which rule to apply. The memory chip could record the calibration of the device used for thermometry. RCAL Resistance Built Into Chip In legacy oximetry sensors there is a resistor which is selected and installed in the sensor connector, to correspond to the wavelength of the red LED, as described in U.S. Pat. No. 4,700,708. The wavelength difference from LED to LED has an impact on the calibration of the saturation measurement, if not compensated for. Oximeters designed for such sensors will read the value of resistance and adjust its calculation accordingly. When adding the memory chip, memory compatible oximeters will be able to obtain the necessary calibration coefficients from the memory chip but the legacy instruments will still need a calibration resistor value. With a resistance properly built-in to the chip and trimmed or selected at sensor manufacture, only one device would need to be installed in the sensor connector. That would reduce the overall-cost, yet keep the sensor compatible with both the legacy instruments and the new memory compatible instruments. Encode Contact Resistance When making measurements of the resistance that is placed in the sensor, for calibration information purposes, one of the factors that can influence that measurement is the contact resistance of the connectors that are between the oximeter and the resistor itself. In order to compensate for connectors that are significant in their impact on the measure, one could encode the contact resistance of the connector and subtract that algorithmically from the measured resistance to get a more accurate measurement of the resistance of the calibration resistor. This would enhance the accuracy with which the resistance measurement is made and therefore make the instrument less prone to miscalculation and therefore inaccuracies in maturation calculation and display. Measure Capacitance to Balance Common Mode Rejection One of the interfering noise sources that can have an effect on oximetry is that of common mode electrical noise. This can come from the surrounding electrical environment. Other instruments, lights, drills etc. can produce electrical fields that can couple into the cable between the patient and the oximeter. Once coupled-in, they can make measurements more difficult, less accurate or not possible, depending on the severity of the noise. To help reduce this common mode noise, differential amplifiers are used for amplifying the signal from the sensor. These amplifiers amplify only the difference between two signal wires. Thus, if the common mode signal is coupled exactly the same into both wires, the amplifier will not amplify it because the same signal is present on both wires. If the two wires have different coupling to their electrical environment then they will present different signals and the difference will be amplified as if it were a signal. One component that influences this coupling is the capacitance of the lines to the outside world. This is affected by the manufacture of the cable, materials, twists in the wire, etc. If one measures the cable during manufacture and then stores that information in the memory chip, it can be read when the oximeter is operating. Once the capacitance for the two wires to the shield are known the instrument can be provided with a tunable capacitance device that balances the two lines and makes the noise coupling to the lines better matched. This reduces the amount of susceptibility to the external noise that becomes coupled into the patient cable. Reduced noise results in better measurements or the ability to make measurements on some patients at all. Active Ambient Light Measurement Another potential source of interference with pulse oximetry sensors is the interference caused by ambient light in the environment reaching the sensor's photodetector. This can be made worse when a sensor comes loose or the ambient light is extremely high in value. By characterizing the sensor during manufacture or by its design one can know the level of ambient light that can be tolerated, and give a warning to the operator when the level has been exceeded. An external measure of ambient light by the pulse oximeter monitor provides operators the opportunity to adjust the sensor, the light, or both to effect an improvement in the performance of the oximeter. This can be accomplished, e.g., with a photodetector positioned on or near the pulse oximeter. Active Pressure Adjustment for Modulation Enhancement The stronger the pulsatile signal the better the chances are of measuring the saturation accurately. One way to enhance the modulation percentage is to apply pressure in the range of the median pulsatile pressure or the mean arterial pressure. When implemented, one can use relatively low cost transducers and supply calibration coefficients in the memory to allow accurate pressure readings to be made. The memory can also contain the pressure settings and/or expected modulation enhancement capability to determine effectiveness of the pressure enhancement. Measure Sensor Wetness A moisture sensor or impedance sensor can detect the amount of wetness of the sensor. This can be used for different purposes, and can be stored in the sensor memory for trending or monitoring. a) To determine sensor malfunction (e.g., Oxicliq). The sensor can be disabled if the wetness exceeds a threshold, which could be stored in the sensor memory. b) Patient isolation. Some sensors may not provide for isolation of the patient from the electronics for excessive wetness. The maximum allowable wetness could be stored in the sensor memory. Display for Additional Wavelengths (More Than 2) The memory can store information about what parameters are to be analyzed and displayed when the extra wavelengths are used in the pulse oximeter sensor. Oxygen saturation may be displayed when 2 wavelengths are used, while additional information could be displayed when an extra wavelength or more are used (Hct, COHb, etc.) While the present invention has been described herein with reference to particular embodiments thereof, a latitude of modification, various changes and substitutions are intended in the foregoing disclosure, and it will be appreciated that in some instances some features of the invention will be employed without a corresponding use of other features without departing from the scope of the invention as set forth. Therefore, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope and spirit of the present invention. It is intended that the invention not be limited to the particular embodiments disclosed, but that the invention will include all embodiments and equivalents falling within the scope of the claims.

1a

BACKGROUND OF THE INVENTION The present invention relates to a plowing depth detecting system for detecting an actual plowing depth of a rotary plow with respect to the ground plowed by the rotary plow, the system being operable based on distance data relative to the ground measured by sensor means attached to the rotary plow. A known plowing depth detecting system of the above-described type includes sensor means forwardly or rearwardly of the rotary plow and detects the actual plowing depth based on variations of distance between the sensor means and ground surface. Where the sensor means is mounted forwardly of the rotary plow, the actual plowing depth is detected by measuring a difference between distances to the ground before and after the rotary plow is lowered (that is, by measuring a distance by which the rotary plow is lowered from the ground surface). However, this construction has difficulties in constantly detecting a precise actual plowing depth owing to undulations of the ground, weeds and the like. On the other hand, where the sensor means is mounted rearwardly of the rotary plow, errors in detecting the actual plowing depth occur with rises of the ground surface after plowing and with changes in posture of the sensor means. SUMMARY OF THE INVENTION The object of the invention is to provide a plowing depth detecting system for a rotary plow, which is capable of accurately detecting the actual plowing depth by correcting distance data provided by sensor means according to working conditions of the rotary plow. In one aspect of the present invention a plowing depth detecting system comprises a rotary plow vertically movably connected to a vehicle through a link mechanism and including a rotor for plowing ground; leveling means for leveling the ground plowed by the rotor; sensor means attached to the rotary plow for detecting a distance between the sensor means and the ground rearwardly of the leveling means; and processing means for determining an actual plowing depth of the rotary plow from distance data received from the sensor means and a correction value based on a working condition of the rotary plow. BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects and features of the present invention will become apparent from the following description taken in conjunction with the preferred embodiment thereof with reference to the accompanying drawings, in which:- FIG. 1 is a side view of an agricultural tractor standing still with a rotary plow lowered, FIG. 2 is a side view of the agricultural tractor engaging in a plowing operation at a selected plowing depth, FIG. 3 is a view showing an indicator and a corrector dial, FIG. 4 is a block diagram of a plowing depth detecting system, FIG. 5a is a side view showing an operation in a dry field, FIG. 5b is a side view showing an operation in a paddy field, FIG. 6a is a graph showing reception levels of ultrasonic waves corresponding to FIG. 5a, FIG. 6b is a graph showing reception levels of ultrasonic waves corresponding to FIG. 5b, FIG. 7 is a table of angles of oscillation of a lift arm and correction values, and FIG. 8 is a block diagram showing automatic plowing depth control. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1, an agricultural tractor is shown comprising a frame 1 carrying right and left lift arms 3 vertically pivotable by a hydraulic cylinder 2 mounted at a rear portion thereof, and a rotary plow 5 vertically movably connected to the lift arms 3 through a three-point link mechansim 4. The three-point link mechanism 4 includes a top link 4a and two lower links 4b. The lower links 4b are connected to the lift arms 3 through lift rods 6. A ultrasonic distance sensor 8 is mounted on a rear end of a support member 7 pivotally connected to extending rearwardly from the rotary plow 5. The support member 7 is pivotable by a hydraulic cylinder 9 to change its posture. A hand lever 10 is operatively connected to an electromagnetic valve 26 for controlling the hydraulic cylinder 2. This construction constitutes a position control mechanism for vertically moving the rotary plow 5 to a position corresponding to a position to which the hand lever 10 is shifted. The rotary plow 5 includes a rotor 5a for plowing the ground. A leveling member 12 is pivotally connected to the rotary plow 5 for leveling the ground plowed by the rotor 5a, the leveling member 12 being urged to neutral position by an urging mechanism 11. The distance sensor 8 is located in a position to measure a vertical distance between the position of the sensor 8 and the ground rearwardly of the leveling member 12. A meter panel 14 provided forwardly of a driver's seat 13 includes an indicating unit 15 for indicating an actual plowing depth of the rotary plow 5. As shown in FIG. 3, the indicating unit 15 comprises a liquid crystal indicator having a bar graph to indicate the actual plowing depth, such that the longer bar represents the greater plowing depth. Signals output by the distance sensor 8 are transmitted through an A/D converter 16 to a microprocessor 17. The microprocessor 17 has an input line for receiving signals from a first switch 18 and an output line for outputting signals to the indicating unit 15 through a decoder 19. The described construction constitutes a plowing depth detecting system and its operation will be described hereinafter. The rotary plow 5 is lowered while the tractor is standing still, to a level in which a lower end of the rotor 5a contacts the ground. In this state, the microprocessor 17 receives from the distance sensor 8 a reference value corresponding to a unplowed ground GO rearwardly of the rotary plow 5. The indicating unit 15 is adjusted to show "0" at this time. Then the rotary plow 5 is lowered further by manually operating the lever 10 of the position control mechanism. During the descent, the magnitude of the distance signal periodically transmitted from the distance sensor 8 to the microprocessor 17 gradually reduces with an increasing amount of subsidence (corresponding to the plowing depth) of the rotary plow 5. The microprocessor 17 operates on a deviation from the initial value and sends the deviation to the indicating unit 15, and this deviation is indicated on the panel 14 as representing the plowing depth. The driver of the tractor stops the descent of the rotary plow 5 when the plowing depth indicated reaches a target value. He then turns on the first switch 18, causing the microprocessor 17 to store the target plowing depth, and starts the tractor. While the tractor is running, a plowed ground surface leveled by the leveling member 12 is formed rearwardly of the rotary plow 5. This plowed ground surface is raised by a substantially constant amount R from the unplowed ground GO. Therefore, when a measurement point of the distance sensor 8 comes to the plowed ground surface GP, the measured distance reduces by the amount of rise R and the indicating unit 15 indicate a plowing depth added with the amount of rise R. In order to correct this error the microprocessor 17 is provided with corrector means. This corrector means is required since the distance sensor 8 has not detected any rise R before the tractor begins to plow as illustrated in FIG. 1 and, accordingly, there is an intitial transient portion of R. This transient portion of R is a function of the distance the tractor initially travels increasing at first and then leveling off. Accordingly, this transient disappears and R becomes a constant when the tractor travels a certain distance or travels at a certain speed for a fixed period of time. In operation when the value detected and output by the distance sensor 8 begins to increase rapidly, a timer comes into operation to interrupt the input of the detected value to the microprocessor 17. The input is resumed when a certain period of time lapses and the measurement point of the distance sensor 8 becomes constant for plowed ground surface GP. Upon receipt of a first detection value from the distance sensor 8 corresponding to the plowed ground surface GP, the microprocessor 17 calculates the deviation by subtracting this detection value from the reference value. Since this deviation represents the sum of the target plowing depth value and the amount of rise R, the amount of rise R is derived by subtracting the stored target plowing depth value from the deviation and is stored in the microprocessor 17. Thereafter, the microprocessor 17 receives a detection value from the distance sensor 8, works out a deviation thereof from the reference value, subtracts the amount of rise R stored as the correction value from this deviation, and outputs a resulting value to the indicating unit 15. The indicating unit 15 shows the input value as the actual plowing depth P. A further embodiment of the plowing depth detecting system will be described next, which is adapted to correct the amount of rise R by using manual corrector means. Referring to FIG. 3, a casing 20 of the indicating unit 15 includes a correcting unit 21 which is one example of the manual corrector means and is operable by a dial 21a. The dial 21a is surrounded by a scale 21b divided for every centimeter from 0 to 16 cms. corresponding to target plowing depths. A correction value (i.e. the amount of rise) is input to the microprocessor 17 by setting a pointer 21c of the dial 21a at a division of the scale 21b corresponding to a desired plowing depth. This scale 21b is determined on the basis of empirical data of the amount of rise R with respect to the target plowing depth obtained in relation with standard or average soil nature. The correcting unit 21 includes a "0" division of the scale to which the amount of correction is set for an operation in a paddy field in view of the fact that a rise of ground surface GP will not be formed when operating in a paddy field. In the plowing depth detecting system including this manual corrector means, the vertical distance between the distance sensor 8 and the lower end of the rotor 5a is stored in the microprocessor 17 as the reference value. The operator shifts the lever 10 of the position control mechanism 10 to lower the rotary plow 5 to a position corresponding approximately to the target plowing depth value. The tractor is started after adjustment is effected by means of the dial of the correcting unit 21. The microprocessor 17 subtracts from the reference value a detection value received from the distance sensor 8 and a correction value selected by means of the dial, and outputs a resulting value to the indicating unit 15. The indicating unit 15 shows this value as the actual plowing depth. The described two corrector means may both be provided along with a changeover switch. Then the plowing depth detection value may be obtained with greater accuracy be utilizing the arithmetic correcting means in the first embodiment for operations on a relatively flat and smooth ground and the manual correcting means for operations on a relatively rough and uneven ground. While the amount of rise R is considered as the correction value in the foregoing two embodiments, it is necessary to consider a different correction value for a different operational mode. As shown in FIGS. 5a and 5b, for example, there is a difference in the vertical distance (or the shortest distance) from the distance sensor 8 to the lower end of the rotary plow 5 between the case of an operation in a dry field (FIG. 5a) and the case of an operation in a paddy field (FIG. 5b) even if the plowing depth x is the same. This is due to a difference in the posture (θ 1 , θ 2 ) of the link mechanism 4 relative to the tractor frame. Therefore, although the plowing depth is the same, a greater detection value is given from the distance sensor 8 to the microprocessor 17 in the case shown in FIG. 5b than in the case shown in FIG. 5a. As a result, the value shown by the indicating unit 15 is smaller than the actual plowing depth x. Where an ultrasonic sensor is employed as the distance sensor 8, a sound wave reflected from the field surface and traveling by the shortest distance is detected and the distance is measured by converting a time lapse from emission of the sound wave to when the sound pressure level of the received sound wave reaches a predetermined value (i.e. threshold level) as shown in FIGS. 6a and 6b. However, since in the case shown in FIG. 6b the direction of center line for the emission of the sound wave from the ultrasonic sensor varies with a vertical movement of the link mechanism, the sound wave reflected from the ground and traveling by the shortest distance has a low sound pressure level due to the deviation from the center line of emission and it takes time for the sound pressure level to reach the predetermined value. Consequently, the distance is measured to be longer than the actual distance and a value smaller than the actual plowing depth is indicated by the indicating unit 15. In order to correct this error, an angle sensor 22 for detecting an angle θ of the lift arms 3 with respect to the tractor frame is provided along with means to converting the angle θ detected by the angle sensor 22 into a correction value. This converting means converts the angle θ input from the angle sensor 22 into the correction value on the basis of data in a table stored in the microprocessor memory. As shown in FIG. 7, this table shows the correction value as a function of the detected angle θ, and the correction value corresponds to a distance converted beforehand from an amount of relative movement of the distance sensor based on the detected angle θ and/or an amount of response delay due to a variation of the ultrasonic sensor 8 with respect to the direction of center line for emission. For a plowing operation in a paddy field which requires such correction means, the dial 21a of the correcting unit 21 is set at the "0" division since raised ground surfaces are not formed. Therefore, while the tractor is running, the microprocessor 17 subtracts from the reference value the value detected by the distance sensor 8 and the correction value provided by the converting means and outputs a resulting value to the indicating unit 15. The indicating unit 15 shows this value as the actual plowing depth. Where automatic plowing depth control is effected on the basis of the actual plowing depth detected by the above plowing depth detecting system, a changeover switch for starting and stopping the automatic plowing depth control, a setter switch for setting a plowing depth value, a plowing depth setting device 23 and comparator means 24 are provided in addition to the elements constituting the plowing depth detecting system. When the changeover switch is turned off and the automatic control is stopped, the operator effects the plowing depth control by means of the hand lever 10 while observing the value indicated by the indicating unit 15. He turns on the setter switch when the indicated value reaches a desired value, whereby this value is set to the plowing depth setting device 23 as a selected value of plowing depth. When the changeover switch is thereafter turned on for the automatic control operation, the microprocessor 17 compares the actual plowing depth value and the selected plowing depth value and derives a deviation. A signal comprising this value and a control gain is transmitted through a driver 25 to the electromagnetic value 26 for operating the hydraulic cylinder 2. In response to the input signal the electromagnetic valve operates the hydraulic cylinder 2 to raise or lower the rotary plow 5 thereby to maintain the actual plowing depth to the selected plowing depth.

1a

[0001] This application is related to U.S. Pat. Nos. 5,555,596, entitled “Floor Cleaning Apparatus”; 5,485,653, entitled “Floor Cleaning Apparatus”; 5,628,086, entitled “Floor Cleaning Apparatus with Squeegee Mounting System”; and 5,608,947, entitled “Floor Cleaning Apparatus With Pre-Filter”; the entire disclosures of which are incorporated by reference herein. This application is also related to U.S. patent application Ser. No. 11/059,663, filed Feb. 15, 2005, now U.S. Pat. No. 7,533,435, which is a Continuation-In-Part of U.S. patent application Ser. No. 10/737,027, filed Dec. 15, 2003, now abandoned, which is a Continuation-In-Part of U.S. patent application Ser. No. 10/438,485, filed May 14, 2003, now abandoned, the entire disclosures of which are incorporated by reference in their entirety herein. This application is also related to U.S. Patent Application Publication Nos. 2009/0094784, 2006/0064844, 2006/0124770, and 2006/0156498, and U.S. patent application Ser. No. 12/511,704, filed Jul. 29, 2009, the entire disclosures of which are incorporated by reference herein. One of skill in the art will appreciate that the aspects described in these references may be combined with the aspects of embodiments of the present invention described herein. FIELD OF THE INVENTION [0002] Embodiments of the present invention generally relate to floor cleaning apparatus that employ a sweeper and scrubber assembly that possesses a vacuum's ability to capture small particles and/or debris and that produces a lower noise output than typical sweeper/brush apparatus. BACKGROUND OF THE INVENTION [0003] Floor cleaning apparatus are generally comprised of a chassis supported by a plurality of wheels, one of which is steerable to control the path of the machine. The chassis also accommodates a cleaning assembly, such as a brush, a sweeper, a squeegee, a burnisher, etc. The chassis also supports tanks used to hold water, cleaning fluids, and spent cleaning fluids suctioned from the surface being cleaned. Floor cleaning apparatus also often possess a receptacle or bag for holding collected dust and debris. The majority of the components associated with the cleaning machine are surrounded by at least one housing that protects the internal components from the environment and prevents individuals that are working around the machine from touching the often hot internal components. As floor cleaning apparatus are sometimes used in tight spaces, such as bathrooms and hallways, it is often desirable to make floor cleaning apparatus as compact as possible. [0004] Some floor cleaning apparatus employ a rotating sweeper broom (“sweeper”) to lift debris from a floor. Generally, a cylindrical sweeper rotates about an axis that is parallel to the floor and which may be located between front and rear wheels of the apparatus. Floor cleaning apparatus also typically include a vacuum system that establishes a directional airstream adjacent to the broom to direct debris into a hopper where heavier debris is precipitated from the airstream. Lighter debris, especially dust, is then typically directed to a vacuum bag. [0005] To enhance the suctioning effect provided by the vacuum, the sweeper may be located in a housing situated between the front and rear wheels. The housing typically includes one or more flaps or seals that surround the sweeper that defines a skirt with a lower edge that contacts the floor. The flaps or seals are generally flexible or hinged to the chassis to allow debris to enter the assembly and be swept up by the sweeper. The flaps or seals also prevent the sweeper from throwing debris and dust as it rotates. [0006] Some floor cleaning apparatus treat the floor with a cleaning solution with at least one scrubber brush. In some apparatus, the cleaning solution is deposited onto the floor and a pair of rotating disk brushes are used to scrub the floor. Wastewater, which includes entrained debris, is then typically suctioned by a vacuum squeegee that is located behind or adjacent to the brushes. [0007] One example of a floor cleaning apparatus is disclosed in U.S. Pat. No. 5,093,955 to Blehert et al. (“Blehert I”) entitled “Combined Sweeper and Scrubber.” Blehert I discloses a floor cleaning apparatus that can be set either to a sweeper mode or a scrubbing mode. Blehert I provides a single cylindrical rotary brush, a brush housing mounted on a frame, a solution tank and a removable debris hopper. When in the sweeping mode, a vacuum operating in conjunction with an air circuit draws air from around the brush and through a filter. When in a scrubbing mode, the vacuum operates to recover dirty scrubbing solution from the rear of the apparatus through a squeegee located aft of the brush. [0008] U.S. Pat. No. 6,041,471 to Charky et al. (“Charky”) entitled “Mobile Walk-Behind Sweeper” discloses a mobile sweeper for cleaning dust and collecting garbage from surfaces. Charky employs a plurality of brushes that direct dust to a collection point where a vacuum blower suctions the debris into a collection container. [0009] U.S. Pat. No. 4,819,676 to Blehert et al. (“Blehert II”) entitled “Combination Sweeping and Scrubbing System and Method,” discloses an apparatus that comprises a sweeping assembly that can be converted into a scrubbing unit and vice versa. The sweeping assembly includes a removable hopper. Cylindrical brushes are also provided that operate in either the sweeping or scrubbing mode. [0010] U.S. Pat. No. 4,580,313 to Blehert (“Blehert III”) entitled “Walk Behind Floor Maintenance Machine” discloses a floor treatment apparatus that has a plurality of wheels, a removal hopper, and a rotatable brush. A removable filter housing is also contemplated and has a prismatic shape. The design of the filter housing is such that a means for vibrating the filter is needed to dislodge particles. Additionally, the cylindrical brushes of Blehert III are not enclosed within the housing. [0011] None of the references discussed above disclose a floor cleaning apparatus with a housing that serves to encase an entire cleaning assembly; 2) a hopper with a taper that allows debris separation; 3) a seal created by a flap located around the cleaning assembly; 4) placement of the cleaning assembly near the front of the device that facilitates air flow; and 5) a retractable vacuum hose. Further, the prior art apparatus are noisy and do not provide a sufficient vacuum. Another drawback is that the prior art apparatus will capture large debris that can potentially cause clogs and damage to internal vacuum components. [0012] Thus it is a long felt need to provide a floor cleaning apparatus that employs a sweeper and scrubber assembly that collects debris of many sizes that is relatively quiet compared to apparatus of the prior art. SUMMARY OF THE INVENTION [0013] It is one aspect of the present invention to provide a floor cleaning apparatus (“apparatus”) that employs a scrubber and sweeper assembly (hereinafter “cleaning assembly”). The cleaning assembly includes a front brush and a rear brush that are partially enclosed by a housing that, with the aid of a vacuum motor, directs air between the front brush and the second brush and into a hopper. The suction provided by the vacuum motor directs particle- and debris-laden air into the hopper wherein smaller particles are suctioned directly into a vacuum bag. The vacuum pressure provided by the vacuum motor is maintained by a seal or flap that is associated with the undercarriage of the apparatus. The hopper of one embodiment of the present invention also includes a screen that captures larger particles while allowing dust and smaller particles to pass therethrough to be suctioned into the vacuum bag. The hopper is removable, which allows the user to clear the larger particles from the apparatus. [0014] It is, thus, another aspect of the present invention to provide an apparatus that is capable of cleaning small particles and large particles. More specifically, the front brush and the rear brush are located under the brush housing. The rear brush is also located near a curved rear wall of the hopper. This configuration allows air and debris to enter the front portion of the cleaning assembly, flow between the rotating brushes, flow behind the curved wall, and flow into the hopper. As one skilled in the art will appreciate, this configuration thus allows for the capture of particles of various sizes, from the very small, i.e., dust, to larger particles of about 0.75 inches. Additionally, larger particles of 8 to 10 inches of length may be captured by some embodiments of the present invention. In one embodiment of the present invention, the brushes are cylindrical and rotate about a longitudinal axis that is parallel to the floor. As mentioned above, a flap or seals may be positioned about the brushes to seal the housing, which enhances suction pressure and facilitates the airflow described above. The flaps may be made of any material, but are preferably made of a compliant material, such as rubber. In one embodiment of the present invention, the rearward flap also functions as a squeegee. [0015] It is another aspect of the present invention to provide a debris tray that also employs a screen that captures larger items. More specifically, the removable debris tray of the hopper of one embodiment of the present invention is tapered wherein a lowermost portion thereof is associated with a vacuum hose that is associated with the vacuum bag. The hopper also includes a screen that is positioned above the debris tray such that debris-laden air passes through the screen and into the tray, where larger debris will be trapped by the screen and prevented from entering the vacuum hose. As is well known in the art, the smaller debris will be deposited into the vacuum bag. The debris tray is removable, which allows the larger particles to be cleared from the cleaning assembly periodically. The screen prevents jamming of the vacuum hose, which is an advantage over prior art apparatus that did not capture larger debris or that captured larger debris only to inadvertently suck them into the vacuum system, which could damage the vacuum hose, vacuum motor or other components of the system. [0016] It is yet another aspect of the present invention to provide an apparatus that has a retractable attachment hose. More specifically, one embodiment of the present invention includes an auxiliary vacuum hose that is interconnected to the vacuum bag by way of a valve. In normal operations, vacuum pressure provided by the vacuum motor suctions debris pulled by the cleaning apparatus. Alternatively, when the attachment hose is employed, the valve closes the vacuum hose associated with the cleaning apparatus and provides vacuum pressure to the attachment hose. The attachment hose may be associated with a hose roller that maintains the curvature of the hose to prevent kinking and the associated airflow reduction. Furthermore, some embodiments of the present invention provide a hose with bellows or other elongation mechanisms. In one embodiment of the present invention, the hose roller is actuated when the operator switches the apparatus to the primary floor cleaning mode. [0017] It is another aspect of the present invention to provide a cleaning device associated which is suspended beneath the main body of the cleaning apparatus. More specifically, embodiments of the present invention provide a spring or other biasing mechanism, which is associated with the main housing of the apparatus on one end and an armature associated with the cleaning device on the other end, that supports the weight of the cleaning device while allowing it to move efficiently along the floor. The spring length and tension may be selectively altered to adjust the amount of “float” the cleaning devices possesses and/or to otherwise tune the functionality of the overall device. Preferably, the selection of spring stiffness is preset by the apparatus designer such that optimum or near optimum performance is achieved regardless of the surface being cleaned For example, if a stiff or short spring is employed, most of the cleaning assembly's weight will cycle from floor to spring, which affects brush contact, brush performance, etc. [0018] It is still yet another aspect of the present invention to provide an apparatus having a unique vacuum bag. More specifically, embodiments of the present invention employ a vacuum bag with a centering tab and an automatic seal that ensures that the contents of the bag do not spill when the vacuum bag is removed from the apparatus. [0019] Thus, it is one aspect of the present invention to provide a cleaning assembly for use in a floor cleaning apparatus, comprising: a housing; at least one cylindrical brush having a longitudinal axis positioned within the housing, the longitudinal axis being parallel to the surface being cleaned; a hopper interconnected to the housing; a screen positioned within the hopper that allows particulates of a predetermined diameter to pass therethrough and that prevents particulates of a diameter larger than the particulates of a predetermined diameter from entering the hopper; and a vacuum hose interconnected to the screen wherein the particulates of a predetermined diameter are suctioned into the vacuum hose. [0020] It is still yet another aspect of the present invention to provide a cleaning assembly, comprising: a means for treating a floor; a hopper associated with said means for treating a floor; a screen positioned within the hopper that allows particulates of a predetermined diameter to pass therethrough and that prevents particulates of a diameter larger than the particulates of a predetermined diameter from entering the hopper; and a vacuum hose interconnected to the screen wherein the particulates of a predetermined diameter are suctioned into the vacuum hose. [0021] It is another aspect of the present invention to provide an apparatus that employs the features described herein in combination with those of U.S. Pat. No. 7,533,435. For example, a floor treatment apparatus comprising: a chassis having a front and a back and with a lower surface, a front surface adjacent the front, an upper surface, a rear surface adjacent the back, a left surface and a right surface; a first wheel operably interconnected to the lower surface adjacent to the left surface and located closer to the rear surface than the front surface; a second wheel operably interconnected to the lower surface adjacent the right surface and located closer to the rear surface than the front surface; a platform located substantially between at least a portion of the right surface, at least a portion of the left surface and extending rearwardly from a portion of the rear surface, the platform also substantially located within the chassis and positioned substantially directly above an axis extending between the center of the first wheel and the center of the second wheel and wherein the platform includes a top surface which is adapted to receive the feet of an operator, a throttle and an operator presence device operatively connected to and which selectively interrupts operation of the throttle; a powered wheel operably connected adjacent the lower surface of the chassis; a steering mechanism substantially housed within the chassis and having a portion that is accessible by an operator; and an operable floor cleaning assembly connected adjacent to the lower surface of the chassis, the improvement comprising: a hopper associated with the chassis; a screen positioned within the hopper that allows particulates of a predetermined diameter to pass therethrough and that prevents particulates of a diameter larger than the particulates of a predetermined diameter from entering the hopper; and a vacuum hose interconnected to the screen wherein the particulates of a predetermined diameter are suctioned into the vacuum hose. [0022] The Summary of the Invention is neither intended nor should it be construed as being representative of the full extent and scope of the present invention. Moreover, references made herein to “the present invention” or aspects thereof should be understood to mean certain embodiments of the present invention and should not necessarily be construed as limiting all embodiments to a particular description. The present invention is set forth in various levels of detail in the Summary of the Invention, as well as in the attached drawings and the Detailed Description of the Invention and no limitation as to the scope of the present invention is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary of the Invention. Additional aspects of the present invention will become more readily apparent from the Detail Description, particularly when taken together with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0023] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention, and together with the general description of the invention given above and the detailed description of the drawings given below, serve to explain the principles of these inventions. [0024] FIG. 1 is a rear perspective view of a floor cleaning apparatus of one embodiment of the present invention; [0025] FIG. 2 is a front perspective view of the apparatus of one embodiment of the present invention wherein some components have been removed for clarity; [0026] FIG. 3 is a schematic showing the major apparatus components of one embodiment of the present invention and their respective interconnections; [0027] FIG. 4 is a cross-sectional view depicting the general structure of a cleaning assembly employed by some embodiments of the present invention; [0028] FIG. 5 is a rear perspective view of a cleaning assembly wherein portions have been removed for clarity; [0029] FIG. 6 is an exploded perspective view of the hopper of the cleaning assembly; [0030] FIG. 7 is a rear perspective view of a brush housing; [0031] FIG. 8 is a detailed perspective view of the apparatus showing a valve in a primary, open position; [0032] FIG. 9 is a cross-sectional view of FIG. 7 ; [0033] FIG. 10 is a detailed perspective view of the valve in a secondary, closed position; [0034] FIG. 11 is a cross sectional view of FIG. 9 ; [0035] FIG. 12 is a partial perspective view of the apparatus showing the attachment hose; [0036] FIG. 13 is a partial perspective view showing a vacuum bag employed by some embodiments of the present invention; and [0037] FIG. 14 is a partial front elevation view showing a spring suspension system employed by some embodiments of the present invention. [0038] To assist in the understanding of one embodiment of the present invention the following list of components and associated numbering found in the drawings is provided herein: [0000] # Component  2 Floor scrubber sweeper apparatus  6 Housing  10 Vacuum bag  14 Vacuum motor  18 Valve  22 Cleaning assembly  26 Armature  30 Accessory hose  34 Front brush  38 Rear brush  40 Motor  42 Longitudinal axis  46 Floor  50 Air path  54 Opening  58 Front end  62 Curved wall  63 Curved wall  66 Hopper assembly  70 Rear wall  74 Bottom wall  78 Screen  82 Fins  86 Opening  90 Vacuum hose  94 Flap  98 Debris tray 102 Housing 106 Brush housing 110 Opening 114 Bag hose 118 Exhaust 122 Flapper 126 Hose roller 130 Capping device 134 Sealing member 138 Tab 142 Spring [0039] It should be understood that the drawings are not necessarily to scale. In certain instances, details that are not necessary for an understanding of the invention or that render other details difficult to perceive may have been omitted. It should be understood, of course, that the invention is not necessarily limited to the particular embodiments illustrated herein. DETAILED DESCRIPTION [0040] FIGS. 1-3 show a scrubber/sweeper apparatus 2 (hereinafter “apparatus”) of one embodiment of the present invention that employs a housing 6 that covers a vacuum bag 10 , a vacuum motor 14 , a valve 18 , and other components generally found in floor cleaning apparatus. In addition, the apparatus 2 employs a cleaning assembly 22 that is attached to the housing 6 via a spring to an armature 26 , which will be further described below. In operation, dirt, debris, and residue are agitated by the cleaning assembly 22 and suctioned into the vacuum bag 10 . In a second mode of operation, a hand-held accessory hose 30 is used to suction debris in hard-to-reach places. The debris suctioned through the accessory hose 30 is also directed to the vacuum bag 10 by the vacuum motor 14 . [0041] Referring now specifically to FIGS. 4-7 , the cleaning assembly 22 employed by some embodiments of the present invention is shown that includes a front brush 34 and a rear brush 38 . The front brush 34 and rear brush 38 may be comprised of a single, cylindrical brush or a series of stacked cylindrical brushes that are rotated by a motor 40 around a longitudinal axes 42 that are generally parallel to the floor 46 being cleaned. In operation, the front brush 34 rotates counterclockwise (as shown in FIG. 4 ) and the rear brush 38 rotates clockwise (as shown in FIG. 4 ). The rotation of the brushes work in conjunction with suction provided by the vacuum motor to define an air path 50 that moves debris from an opening 54 positioned adjacent to the front end 58 of the cleaning assembly 22 , under the front brush 34 , between the front brush 34 and the rear brush 38 , and behind the rear brush 38 . A curved rear wall 62 that is spaced from the rear brush 38 further defines the air path 50 . The rear wall 62 has a larger radius of curvature than the rear brush 38 . In one embodiment, the space between the brush and wall increases wherein the space between the rear wall 62 and the rear brush 38 is greatest at the top of the rear wall 62 . The top of the rear wall creates an opening 110 into the hopper and is positioned at about the same height as the top of the brush so the brush does not capture debris from the hopper 66 . The spacing to the top of the housing (opening size) is about 1 inch. A curved front wall 63 that is spaced from the front brush 34 also helps to define the air path 50 . Similar to the arraignment of the rear brush 38 and the rear wall 62 , the front wall 63 has a slightly larger radius than the front brush 34 . The front wall 63 is positioned so that the space between the front brush 34 and front wall 63 is greatest near the top of the front brush 34 , which helps the movement of debris that may become trapped between the brushes and housing 102 . [0042] The cleaning assembly 22 also includes a hopper 66 partially comprised a rear wall and a bottom wall 74 . Airflow is directed by the brushes around the curved wall 62 into the hopper assembly 66 . The hopper assembly 66 includes a screen 78 that allows smaller particles and debris to pass to a center opening 86 , but prevents the passage of larger debris from reaching the opening. In one embodiment of the present invention, the screen 78 is comprised of a plurality of fins 82 that are angled such that the airflow and carried debris is directed to a center opening 86 of the screen assembly 78 and which is in fluid communication with the vacuum hose 90 . To increase vacuum and in some embodiments to help to provide the air path 50 shown, a flap 94 may be provided around at least three sides of the cleaning assembly 22 . FIG. 2 only shows a rear flap 94 , one skilled in the art will appreciate that additional side flaps may be employed to ensure a sufficient vacuum is created to enhance the contemplated air path 50 . The flap 94 is selectively rotatable and thus able to deflect with respect to the cleaning assembly 22 as the apparatus moves over the floor 46 . [0043] FIG. 6 shows the debris tray 98 that is integrated into the cleaning assembly 22 . The debris tray 98 is selectively interconnected to a brush housing 106 of the cleaning assembly. The debris tray 98 is also concave or angled in such a way that the lowest point is adjacent to the opening 86 provided in the screen. The concave nature ensures that debris will move towards the opening 86 as the cleaning assembly vibrates to be suctioned by the vacuum hose 90 . [0044] FIG. 7 shows the brush housing 106 that contains the front brush and rear brush. The brush housing 106 is contoured to match the diameter of the brushes, which will enhance the ability of the cleaning assembly to create the contemplated air path. The brush housing 106 provides the elongated opening 110 above the curved walls 62 and 63 that allows air and debris to enter into the hopper. In one embodiment, the opening is about 1 inch wide. [0045] Referring again to FIGS. 1-7 , in operation, dirt, dust and debris is pulled from the floor 46 through an opening 54 in the cleaning assembly 22 . The debris-laden air and other particulate matter are directed between counter rotating brushes, over the rear brush 38 , and into the hopper 66 . Large particulates are maintained by the screen 78 , while smaller particulates and dust-laden air are suctioned through the vacuum hose 90 . As one skilled in the art will appreciate, other items such as fluid dispensing devices and scrub brushes may be employed along with this concept to further clean the floor. The air and/or fluid are suctioned through the vacuum hose 90 to a valve 18 . The vacuum motor 14 draws air through the vacuum bag 10 that includes a filter to catch small particles. Air exits the vacuum bag 10 through the vacuum motor exhaust 118 . The exhaust may include a “post filter” to remove additional fine particles and a carbon element to remove odors. To the extent liquid is the fluid which is being collected, it will be deposited in known fashion into a receiving receptacle. [0046] Referring now to FIGS. 1-3 and 8 - 12 , the valve 18 and accessory hose 30 of embodiments of the present invention is further described. As mentioned above, the vacuum pressure provided by the vacuum motor 14 suctions air through the vacuum hose 90 . The suctioned air enters into the valve 18 that includes a flapper 122 . When open, ( FIGS. 8 and 9 ), the flapper 122 only allows the debris-laden air from the hopper to be deposited into the vacuum bag 10 via a bag hose 114 . When closed ( FIGS. 10 and 11 ), the flapper 122 allows air from the accessory hose 30 to be deposited in the vacuum bag 10 . The accessory hose 30 may be flexible or otherwise stretchable and is associated with a hose roller 126 interconnected to the housing 6 of the apparatus 2 . In operation, when the end of the accessory hose 30 is closed with a capping device 130 , the accessory hose 30 is retracted within the housing 6 as shown in FIG. 2 . When in use, the capping device 130 is removed and an accessory is interconnected to the end of the accessory hose. The accessory hose's flexibility and elongation capabilities allow the user to access debris in hard-to-reach places. [0047] As shown in FIG. 13 , the bag hose 114 is interconnected to the vacuum bag 10 that employs a sealing member 134 . The sealing member 134 ensures that when the bag hose 114 is installed, a tight seal is created between the hose and seal. The bag includes a tab 137 , which is designed to mate with protrusion 138 found in the bag holding chamber. The tab 137 and protrusion 138 ensure that the bag is always installed correctly. Also, the bag comes with a seal 139 removably installed thereon. The seal is used to cover the hole in the sealing mechanism when the bag is being replaced or emptied to ensure no debris will spill from the vacuum bag 10 . [0048] FIG. 14 shows a spring 142 that is interconnected to the armature 26 of the cleaning assembly. The spring 142 provides suspension of the cleaning apparatus. Selectively altering the spring stiffness allows the designer to adjust the force applied to the floor by the brushes. More specifically, the spring stiffness is preferably preselected and is a function of design and cleaning assembly configuration and weight so that the operator can use the machine on many surfaces without adjustment. A long spring, for example, is less sensitive to changes in length and allows for variations in the floor surfaces without significant change to the amount of cleaning assembly weight felt by the floor. [0049] While various embodiments of the present invention have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present invention, as set forth in the following claims. Further, the invention(s) described herein is capable of other embodiments and of being practiced or of being carried out in various ways. In addition, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

1a

The present invention relates to a light table, or light box, for X-rays. It is particularly applicable to medical applications where it is used for examining X-ray negatives. However, it may also be used in other applications. In a particularly advantageous implementation, the table of the invention is used for examining stereographic negatives: i.e. negatives corresponding to the body under examination being irradiated at two different angles. These negatives are presented simultaneously on the light box in order to make it easier for an observer or for a recognition machine to visualize in depth particular points in the body under examination or to locate them in three dimensions. BACKGROUND OF THE INVENTION Light boxes for X-rays are known in the prior art. They are essentially constituted by a translucent slab placed over lighting means. X-ray negatives to be examined are placed on the slab. The outlines and the structures which they represent are observed by differences in the attenuation of the light energy transmitted from the lighting means to the eye of the observer through the negative. In stereotaxis examination for the purpose of determining the XYZ co-ordinates in three dimensions of a particular region of the body under examination (generally a lesion), two such negatives taken under two different angles of incidence are placed on the slab. Light boxes intended for this purpose also include moving spot index marks which make it possible to accurately locate points to be analyzed on the negatives. These index marks are generally driven by a mechanical device actuated by an operator. The operator actuates the mechanical device to bring the index marks into coincidence with the points to be analyzed on the film. A transcribing device records the mechanical displacements performed and transmits the corresponding position co-ordinates of the index mark to a computer. In conventional manner, the computer performs suitable processing to compute the three dimensional coordinates of a lesion on the basis of the positions of two index marks placed in like manner on each of the corresponding parts of the stereographic negative. The co-ordinates may be displayed on a video monitor or on any other appropriate means. They may also be used in a therapeutic treatment device or in a device for taking tissue samples for the purposes of cytological analysis. In order to transmit the position of an index mark, the transcribing devices include a mechanical portion. The presence of this mechanical portion means that the transcribing devices have low accuracy. The exact position of the index mark is always transcribed with a degree of error because of bending or because of play. In addition, such transcribing devices are both expensive and heavy. Finally, because of their mechanical nature, they are liable to come out of adjustment and consequently they require frequent maintenance: cleaning, greasing, and recalibration. Such an apparatus is described in FR-A-2 248 535. In addition, when examining stereographic negatives, it may be advantageous to have more than one pair of corresponding index marks available. Given the mechanical nature of the means for putting the index marks into place, it may be necessary to move a previously placed mark out of the way when placing a new mark because the mark-placing mechanisms, cannot overlap or crossover. That is why the maximum number of corresponding index mark pairs which can be used is small: the maximum known number being three. The object of the invention is to remedy these drawbacks by providing a light box in which the slab and the lighting means beneath it are replaced by a graphics screen of one of the types now widely available commercially. In one example, the screen used is a matrix of light-emitting diodes (LEDs). It is also possible to use screens implementing other technologies: plasma screens; liquid crystal screens; or even cathode ray tubes. Nevertheless, the graphics screen is used in a way which is different from the way in which such screens are normally used. A graphics screen normally comprises a plane which is not very bright: brightness occurs only at those locations which are to represent drawing lines. The invention proceeds differently. The screen is caused to emit light all over. It becomes dark only at points corresponding to the positions at which index marks are to be located. The screen must therefore have sufficient brightness to be about as bright as a current light box. In addition, the outside surface of the screen which is being used as a slab should preferably be flat. This means it can receive X-ray negatives without warping them. A graphics screen is essentially characterized by its suitability for enabling the positions of its inverse brightness pixels (i.e. dark points) to be determined in an associated frame of reference. This may be achieved by any appropriate means. For example, position may be determined as a function of time within a frame of a video signal being displayed on the screen, with the time position of the pulse in this signal which corresponds to the dark portion being measured. If an image memory is used, then the addresses (the co-ordinates) of the dark points on the screen are directly related to the addresses of those memory cells in the image memory which contain information about the dark points (e.g. which contain a zero bit) unlike the remainder of the image which is bright (e.g. corresponding to one bits). SUMMARY OF THE INVENTION The present invention therefore provides a light box for X-rays, the table comprising a light-emitting surface for illuminating an X-ray negative placed on said surface, and at least one moving index mark which can be displaced over said surface to point to a particular location of the negative, wherein the table comprises a graphics screen controlled by a microprocessor to emit image-observation light at all points of the screen other than at points pointed to by an index mark. In stereographic applications, there are a plurality of index marks. The positions of the index marks are correlated in pairs, and a conventional computer program reads the addresses of these index marks directly in order to determine which region of three dimensional space contains the object pointed to by the index marks. BRIEF DESCRIPTION OF THE DRAWINGS An embodiment of the invention is described by way of example with reference to the accompanying drawings, in which: FIG. 1 is a diagram of a breast X-ray machine for obtaining a stereographic negative suitable for examination by making use of the invention; and FIG. 2 is a diagram of the essential means constituting a light box of the invention. DETAILED DESCRIPTION FIG. 1 shows an X-ray machine suitable for obtaining stereographic X-ray negatives of the breast. Like any other X- ray machine, this machine includes an X-ray tube 1 emitting X- rays along a main axis 2 towards a breast 3 to be X-rayed, which breast is supported on a support tray 4. The tray 4 is fixed to a frame 5 of the machine. After passing through the breast 3, the X-rays produce an image on a photosensitive plate 6 placed in a cassette 7. The cassette is held in place relative to the X-ray tube 1. A stereographic breast X-ray machine is also capable of making an image at different locations, on the same plate 6, e.g. on the left 8 or on the right 9 depending on whether the X-ray tube 1 is in a first orientation 10 or a second orientation 11 relative to the breast 3. These different orientations are made possible by carrying the tube 1 on a boom which rotates about a center of rotation. The images of the breast 3 are then projected respectively at locations 12 and 13 on the plate 6. On the basis of the two images 12 and 13 which are thus preferably to be found side by side on a single negative, and which correspond to a known difference of angle of incidence 14, it is possible to point to matching characteristic regions, respectively 15 and 16, in each of these images and to use a computer to determine the position in three dimensions (e.g. above the breast-supporting tray 4) of a portion of the breast 3 whose shadows correspond to said matching regions. Under these conditions, it is possible to use a needle-carrying tray 17 including a biopsy needle 18 driven by a motor 19 to insert the needle into the breast 3 at the particular location from which tissue is to be taken for the purpose of analysis. FIG. 2 shows a light box implementing the invention. The special feature of the light box of the invention is that it includes a graphics screen 20 which, in the preferred embodiment, comprises a transparent slab 21 placed over a plane grid 22 of light-emitting diodes (LEDs). The graphics screen 20 is controlled by a microprocessor 23 so that all of the LEDs in the grid 22 emit light. When the screen 20 is a plasma screen or a cathode ray screen, then the microprocessor generates a video signal such that all of the points on the screen are illuminated prior to any index marks being put into place. A control box 24 is coupled to the microprocessor and has a set of knobs such as 25 to 28 for enabling one of the available index marks, e.g. I 25 , to be selected. Once selected, the index marks I 25 to I 28 can be moved over the surface of the screen 20 by means of a set of potentiometers 29 and 30 for controlling X and Y displacements. The control box 24 is shown here merely by way of example. In particular, it may comprise control means which are more ergonomic, for example a mouse or a trackball. When the control box 24 is manipulated, instructions are sent to the microprocessor which cause it to display an index mark. As it does this, the microprocessor naturally stores in its memory the addresses of the positions of the index marks in terms of X and Y offsets relative to a reference mark 31 on the screen. Thereafter, given the pitch of the image points (pixels) on the graphics screen, it is easy to compute the co-ordinates of the positions of these index marks. The accuracy of the device of the invention depends only on the linearity of the pixel pitch. The resolution with which the index marks can be put into place depends only on the pixel pitch of the graphics screen itself. For a given graphics screen, these two parameters are fixed by construction. Given the production technology for graphics screen masks, these positions are thus very accurate and easily reproducible from one screen to another. In one example, using 10 cm ×20 cm screens, suitable for stereotaxy in mammography, it is easy to find screens having a pixel pitch of about 0.25 mm to 0.3 mm. This is sufficiently accurate. It can immediately be seen that a device made in this way cannot go out of adjustment. Its accuracy is obtained by construction and not by (frequently repeated) adjustments of a mechanical linkage. In addition, there is no wear, and thus very little maintenance, thereby ensuring that the apparatus is very reliable. Finally, the falling prices of electronic components make it possible to anticipate production costs which are considerably lower than present costs. However using a graphics screen together with a microprocessor also provides much greater operator comfort. In particular, a character generator 34 can be used for distinguishing various types of associated pairs of corresponding index marks. For example, index marks I 25 and I 26 may be represented by small crosses, whereas index marks I 27 and I 28 may be represented by small crosses within respective circles. It can immediately be seen that by selecting a different type of character in this way, the index marks can be associated in as many pairs as desired, and also that by using a microprocessor associated with a graphics screen, it is possible to displace the index marks without worrying about possible mechanical linkage overlaps. The characters displayed as index marks may also be distinguished from each other by brightness: e.g. by being brighter than the background. They may also be distinguished by color, if the graphics screen is a color screen. An index mark may therefore correspond to a single pixel or to a plurality of pixels on the screen. Similarly, by reserving a region 32 at the periphery of the screen 20, the character generator can be used to write messages such as "CONFIRM POINTING", thereby informing the operator who is manipulating the control box 24 how to perform the next expected operation. In addition, the light box of the invention makes all sorts of improvements possible. For example, the positioning of the film 6 on the surface of the slab 21 can be replaced by injecting a digital representation of the image of the film 6. Transforming an X-ray image into a digital image is common practice. The digital image can then be stored via the microprocessor 23 in an image memory 33. The image memory 33 is read by the microprocessor 23 and is displayed on the graphics screen 20 simultaneously with its display of the index marks I 25 to I 28 . As mentioned above, it is known how to perform the processing required for computing the co-ordinates of a lesion. The microprocessor 23 may be capable of running a program 35 for performing this processing. When processing is completed, it can deliver data representative of the position in three dimensions of the point specified by combined examination of the two stereographic images together. This information may be displayed on a display monitor 36. This information may also be used for controlling the motor 19 for displacing the biopsy needle 18. In order to make this chain more effective, the film 6 contained in the cassette 7 may be replaced by an X-ray image intensifier screen. The video signal delivered by this intensifier screen can be processed and transformed into a digital image which can be displayed directly on the graphics screen 20. The operator who performs the stereographic examination can then manipulate the control box 24 to inform the microprocessor 3 of the corresponding positions of the points to be treated. The microprocessor 23 then runs the program 35 and can control the motor 19, almost in real time. This can accelerate therapy which a patient always finds arduous.

1a

BACKGROUND OF THE INVENTION 1. Field of Invention The present invention relate to a shelf, more particularly to a shelf mounted on a pair of rails fixed on a wall, which shelf can be raised or lowered to a desired height and such that the angle between the shaft and said fixed rails can be adjusted. 2. Description of the Related Art FIG. 1 shows a conventional shelf. As illustrated in Figure, the shelf includes a pair of rails (10) fixedly mounted on a wall and a plate (20) disposed on the rails (10). Such a shelf can not be lowered or raised as desired. FIG. 2 shows another type of conventional shelf. Accordingly, it includes a pair of rails (10) having a plurality of holes, fixedly mounted on a wall. A plate (20) is provided on a pair of studs inserted in these holes. The plate (20) of such a shelf can be raised or lowered when desired, but the angle of the plate with respect to the rails (10) can not be changed. SUMMARY OF THE INVENTION Therefore, the main object of the present invention is to provide a shelf with provision by which the height and angle of the shelf with respect to the mounting wall can be adjusted. Accordingly, a shelf of the present invention includes a pair of rails, spaced apart from one another in a parallel relationship, and vertically mounted on a wall, a rectangular frame having a first elongated member disposed between said pair of rails, and a second elongated member extending substantially perpendicular to said first elongated member, an engaging member which is slidable along said rail, and disposed between one end of said first elongated member and said rail, means to retain said first elongated member at a desired height along said rails by said engaging member and means to retain said second elongated member at a desired angle with respect to said rails by said engaging member. BRIEF DESCRIPTION OF THE DRAWINGS Other features and advantages of the present invention will become more apparent in the following detailed description, including drawings, all of which show a non-limiting form of the invention, and of which: FIGS. 1 and 2 show two kinds of conventional shelves. FIG. 3 is a perspective, schematic view of a shelf of the present invention. FIG. 4 is an exploded view of a shelf, according to the present invention. FIG. 5 illustrates installation of a shelf of the present invention and adjustment of its height. FIG. 6 is an illustration of how the angle of the present invention can be adjusted. FIG. 7 shows a shelf of the present invention in use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGS. 3 and 4, a shelf of the present invention includes a pair of rails (1), spaced apart from one another in a parallel relationship, and vertically mounted on a wall. Each of the rails (1) includes an inner recess (111) and an outer recess (112) formed along said rail. The outer recess (112) has a plurality of positioning holes (113) formed therealong. The outer recess (112) is covered by an elongated plate (114) to enhance its appearance. A rectangular frame (2) includes a first elongated plate (22) disposed between the two rails, and a second elongated plate (21) extending perpendicularly from the first elongated plate (22). The second elongated plate (21) has a mounting hole (113b) adjacent to one end thereof. Each of an engaging members (115) have a through-hole (113A) aligned with the mounting hole (113B) of the second elongated plate (21) and a curved edge. The outer edge of the curved edge has a plurality of notches (116) along, and the engaging member (115) is disposed between one end of the elongated plate (22) and each of the rails (1). The engaging members (115) are slidable in the inner recess (111) of the rail (1). A hollow tube (31) has a first end flush with the periphery of the mounting hole (113B) of the second elongated plate (21). A cap (312) has a threaded stem and a through-hole (313) along the axis of the stem. The stem passes through the mounting hole (113B) and holds the hollow tube (31) in place. A slit (212) is formed on the second elongated plate (21) adjacent to said mounting hole (113B). A rod (33) is received in the hollow tube (31) around which, a coil spring (32) is sleeved over the rod (33). The coil spring (32) urges a first end of the rod (33) to extend out of the first end of the hollow tube (31), passing through the through-hole (113A) of the engaging member (115), and through the cap (312) into one of the holes (113) of the rail. Thus, the first elongated plate (22) is engaged in said rail. A second end of the rod (33) extends out of the second end of the hollow tube (31) and is connected to a pull member (34). Under these conditions, the hollow tube (31) is adjacent to and parallel to the first elongated plate (22). The second end of the elongated rod (33) is connected to the pull member (34) and secured thereat by means of a screw (311). The first end of the elongated rod (33) can be retracted from the hole (113) of the rail (1) into the hollow tube (31), by pulling the pull member (34). Thus, the first elongated plate (22) can be raised or lowered to a desired height along the rails (1). The second elongated plate (21) has a slit (212) adjacent to the mounting hole (113B) of the same. An elongated plate (210) has a tab (214) laterally extending from one end thereof. The other end of the elongated plate (210) has a recess portion (215) into which recess portion, a serrated plate (216) is fixedly mounted. The elongated plate (210) is mounted on the second elongated plate (21), as illustrated in FIG. 4, with the tab (214) of the elongated plate extending out of the slit (212) of the second elongated plate (21). A toothed rod (4) has an axial through-hole (41), into which a first end of a linking rod (42), is inserted and secured by means of a screw (444). A threaded wheel (43) is coaxially mounted in a position adjacent to a second end of the linking rod (42). The threaded wheel (43) of the linking rod (42) is engaged with the serrated end of the elongated plate (210). The second end of the linking rod (42) passes through the hole (217) of the second elongated plate (21) and is connected to a control arm (45). A bracket (46) has a ring (47) through which the toothed rod (4) passes. The bracket (46) is fixed to the other first member (22), in-between a pair of the second elongated plates (21). The ring (47) has an internally toothed hole to engage with the toothed rod (4). The spring (48) has one end abutting the inner portion of the bracket (46) while the other end is fixed in a hole (471) in the ring (47). Thus the toothed rod 4 is spring loaded, and will return to a predetermined rest condition unless force is applied to rotate it axially. As shown in FIG. 6, the assembly is arranged such that when the toothed rod (4) is in the rest position, the toothed wheel (43) holds the plate (210) in a position where the tab (214) at the end of the plate (210) passes through the slit (212) in the second elongated plate (21) to engage one of the notches (116) of the engaging members (115). The control arm (45), being fixed to the toothed wheel (43), can be rotated against the force of the spring (46) which will cause the wheel (43) to spin. The teeth of the wheel (43), being engaged in the serrated plate (216), will draw the plate (210) toward the toothed rod (4), pulling the tab (214) free of the notch (116). Then the angle of the shelf can be changed. Releasing control arm (45) will allow the assembly to return to the rest condition, fixing the shelf in the selected angular relationship with the rails. As illustrated in FIG. 7, a connecting bar (12) is provided between the pair of rails (1). Some fastening plates (122,123) are also provided on the connecting bar (12) through which screws can be inserted to secure the entire assembly to a mounting wall. The method of adjusting the shelf was described above. With the invention thus explained, it is obvious to those skilled in the art that various modifications and variations can be made without departing from the scope and spirit of the present invention. It is therefore intended that this invention be limited only as indicated in the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a safety device for fluid transfer systems and, more particularly, to a safety device operable in response to detection of a predetermined negative pressure level in one or more intake lines of a fluid transfer system to eliminate a vacuum therein, thereby removing a suction force at the open ends of the intake lines. 2. Description of the Related Art Drowning is the second leading cause of unintentional injury related deaths to children 14 years old and younger. While most drownings occur in swimming pools, a surprising fact is that in many swimming pool and hot tub drownings (both adults and children), the main culprit is the water circulation system. In a typical pool, the circulation system includes a main drain suction intake line and at least one skimmer suction intake line, both of which feed into a main intake line that leads to a pump. A return line directs water flow back into the pool. Most people do not feel threatened by a pool's circulation system, including the main drain intake on the bottom of the pool, and the skimmer boxes along the side of the pool. However, if a person comes into contact with any of the suction intake lines of the circulation system (at either the main drain or skimmer intakes) causing the suction intake to be covered or obstructed, the immense suction of the pump forms an instant seal between the open end of the suction intake line and the person's skin or clothing. This may result if a person places their hand over the open end of the suction intake line or, as often happens with children, a person sits down on the suction intake. In either case, the force needed to pull them free often exceeds 800 pounds. Moreover, the injuries which are inflicted in a matter of a few seconds are horrific, usually permanent and sometimes fatal. If a person, especially a child, is sucked onto the main drain suction intake on the bottom of the pool, they usually drown. The only way to free a person sucked onto the intake of a circulation system of this type, without causing severe injury or dismemberment, is to interrupt or disable the source of the suction force, i.e., the pump. This can be done by interrupting power to the pump. However, even if the pump is shut down, a vacuum will remain in the intake side of the system between the pump and the obstructed end of the suction intake line. Nonetheless, a victim could still be freed with some assistance, causing minor injuries. Ideally, if the vacuum in the intake line can be quickly eliminated after a victim becomes stuck to the intake, the victim will be freed with little or no assistance and without injury. In most instances wherein a victim becomes stuck to an intake of a circulation system, typically in a swimming pool or hot tub, rescuers fail to realize the need to immediately shut off the pump. Instead, in a panic, people tend to go to the victim and attempt prying them free. In the rare instance this is successful, the injuries are often severe and permanent. Of course, there are also instances wherein there are no other people present to come to the victim's rescue. These situations are almost always fatal. The imminent danger presented by fluid circulation systems of the type commonly found in swimming pools, hot tubs, and the like has been longstanding in the art. Little, if any, attention has been given to providing a satisfactory solution to this deadly problem that exists in every swimming pool, hot tub, as well as all other fluid circulation systems wherein a fluid is drawn from a reservoir through one or more suction intakes by a pump. Accordingly, there has been and there remains an urgent need to provide an effective means of preventing death and injury to those otherwise unfortunate victims who become unexpectedly attached by suction to the intake of a fluid circulation system. SUMMARY OF THE INVENTION The present invention is directed to a device for use in a fluid transfer system of the type including at least one pump which draws water from a reservoir through one or more intake lines each extending from an open end at the reservoir to an intake of the pump. The primary purpose of the invention is to save lives and property by alleviating the intense vacuum that builds when one or more of the suction intake ports of a pump assisted fluid circulation system becomes obstructed. The safety device includes means for analyzing negative pressure levels sensed in the fluid transfer system. Upon detecting a negative pressure level being outside of a normal operational range, vacuum pressure relief means are actuated for eliminating negative pressure in the system, thereby removing suction at the open ends of the intake lines. The device may further disable the pump, shutting it off, upon detecting the abnormal negative pressure level. Warning devices, including audible and visible alarms, may be provided to indicate that operation of the fluid transfer system has been interrupted. This is especially useful to alert users to the possible occurrence of an obstruction of the intake lines by a person or object and the need to inspect and reset the device prior to reactivating the fluid transfer system. Other options can also be made available, including an automatic pump shutdown, remote alarms, visual indicators, and the like. OBJECTS AND ADVANTAGES OF THE INVENTION With the foregoing in mind, it is a primary object of the present invention to provide a safety device for use in a fluid transfer/circulation system, wherein the device is structured to eliminate negative pressure in the system upon detecting a negative pressure level being outside of a selected operational range, thereby removing suction at the open ends of the intake lines. It is a further object of the present invention to provide a safety device which is particularly useful in the fluid circulation systems of swimming pools, hot tubs and the like for preventing death and injury to persons or animals which become attached by suction to the intake openings of the system. It is still a further object of the present invention to provide a safe, reliable and relatively inexpensive safety device for easy installation to existing fluid transfer/circulation systems and which is structured to eliminate negative pressure in the system upon detecting a negative pressure level being outside a predetermined range, thereby removing suction at the open ends of the intake lines. It is still a further object of the present invention to provide a reliable, relatively inexpensive safety device for use in a fluid transfer/circulation system of the type including at least one pump which draws water from a reservoir through one or more intake lines, wherein the device is structured to deactivate the pump(s) and to further eliminate negative pressure in the system upon detecting a negative pressure level in the system being outside of a predetermined range. It is still a further object of the present invention to provide a safety device, as described above, further including warning devices such as, but not limited to, audible and visible alarms, to indicate that the safety device has been triggered to eliminate negative pressure in the intake lines of a fluid transfer system. These and other objects and advantages of the present invention are more readily apparent with reference to the following detailed description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which: FIG. 1 is a block diagram illustrating the primary components of the safety device and their functional interrelationship, in accordance with a first preferred embodiment of the present invention; FIG. 2 is a circuit diagram of the sensor of the embodiment of FIG. 1; FIG. 3 is a circuit diagram of the analyzer of the embodiment of FIG. 1; FIG. 4 is a circuit diagram of the control and relay components of the embodiment of FIG. 1; FIG. 5 is a schematic diagram illustrating interconnection of the safety device of FIG. 1 to a fluid transfer/circulation system of the type commonly used in swimming pools and hot tubs; FIG. 6 is an elevational view, in partial section, illustrating a typical fluid circulation system for circulating fluid in a reservoir, such as a swimming pool, hot tube or the like, showing the safety device of the present invention installed in-line on a main suction intake line of the system, between the intake of the system's pump and suction intake openings in the swimming pool; FIG. 7 is an elevational view, in partial section, illustrating an alternative embodiment of the safety device of the present invention; FIG. 8 is a top plan view of the safety device of the embodiment of FIG. 7; FIG. 9 is an elevational view of the safety device of the embodiment of FIG. 7; and FIG. 10 is a top plan view taken alone the plane of line 10--10 of FIG. 7. Like reference numerals refer to like parts throughout the several views of the drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is directed to a fluid vacuum safety device 50 for use in a pump assisted fluid circulation system for the purposes of alleviating an intense vacuum that builds in the system when one or more of the suction intake ports of the circulation system become obstructed. Referring to FIG. 6, a typical fluid circulation system of the type commonly found in swimming pools and hot tubs is shown. A reservoir of water W is contained within a structure having side walls 2 and a bottom 4. A main drain 6 having a drain cover grating is provided on the bottom 4. At least one skimmer box 8 is provided along one or more of the side walls 2 at the water surface level SL. A drain suction intake line 10 leads from the main drain 6 to a main suction intake line 20. A skimmer suction intake line 12 has an open end 13 in the skimmer box 8 which is maintained below the water surface level SL. The skimmer suction intake line 12 feeds into the main intake line 20. The main intake line 20 is directed to a pump 24 which may have a screen trap 26 connected to the main intake line 20, just prior to the intake of the pump 24. A main output line 28 leads to a filter 30. One or more return lines 32 extend from the filter 30 back to the water reservoir W to return water that is circulated through the system back to the reservoir W. FIG. 6 shows the fluid vacuum safety device 50 properly installed in-line along the main suction intake line 20 of the circulation system, prior to the intake of the pump 24 and screen trap 26. If an object or person is caused to be sucked onto one of the open ends of the suction intakes, such as the open end 13 of the skimmer suction intake 12, the drain plate 7 or, if the drain plate is removed, the drain suction intake line 10 at the main drain 6, a vacuum will instantly develop throughout the intake lines, including the main suction intake line 20. The fluid vacuum safety device 50 is designed to react to this situation to immediately eliminate the vacuum in the system and, accordingly, the suction force at the open ends of each of the suction intake lines, including the skimmer suction intake 13 and the main drain intake 6. Upon reaching a predetermined vacuum level, which happens quite rapidly when one of the intakes becomes obstructed, the fluid vacuum safety device 50 causes air from atmosphere to be rapidly introduced into the main intake line 20 and throughout the other intake lines, thereby removing all suction force at the open suction intake ends 13 and 16 in the reservoir W. The air introduced into the system interrupts the prime of the pump 24, thereby eliminating any further source of suction. Referring to FIGS. 1-5, a first preferred embodiment of the present invention is shown. The principal components of the fluid vacuum safety device 50 are shown in FIG. 1 and include a sensor circuit 120 which senses the vacuum level in the fluid circulation system. The output of sensor circuit 120 is applied to an analyzer circuit 130 that allows the selective setting of a particular vacuum level (a predetermined vacuum level) by control circuit 140 that will define a trip point or emergency condition in the system. The analyzer circuit output is applied to the control circuit 140 for further processing and control of operational relays or contactors 150. An isolated power supply 160 furnishes voltage for the circuitry. The sensor circuit 120 is depicted in FIG. 2 and utilizes a strain gauge 122 (SG1) to sense the vacuum in the pump return line 20. The four internal elements, R1, R2, R3, and R4, in the strain gauge 122 form a bridge circuit. At 0" of mercury vacuum pressure, the bridge circuit 122 is balanced and the output of the bridge is 0, with the junction of R1/R3 being equal to the junction R2/R4. The output of the junctions are applied to the inputs of IC1, an operational amplifier 124. When the bridge is balanced, the output of the operational amplifier 124 is approximately one-half the power supply voltage. As vacuum increases, the bridge becomes unbalanced and the R1/R3 and R2/R4 junctions change voltage levels in a direct relationship to vacuum pressure level in the system. This small change in voltage is amplified by the operational amplifier 124 and provides a useable level for the analyzer circuit 130. Resistor R5 sets the minimum gain of the operational amplifier, while the adjustable resistor R6 sets the maximum gain. The ability to control gain is necessary due to the wide variations of vacuum levels found in different systems. In a preferred embodiment, the operational amplifier 124 is a type 741 IC. The analyzer circuit 130, as shown in FIG. 3, contains a resistor ladder network 132 composed of resistors R1-R9. Both R1 and R9 are variable resistors. Resistors R2-R8 are all equal value resistors. In this manner, a high point and a low comparator point can be set via the R9 and R1 resistors, respectively, leaving six other equally valued comparator points between the high and low points. The voltages derived from this ladder network 132 are applied to the positive inputs of the comparator circuits 134 (IC1) and 136 (IC2). The output of the sensor circuit 120 is applied to the negative inputs of the comparators 134, 136. The normal output of the sensor circuit 120 is approximately one-half of the supply voltage. R9 is adjusted so that the positive input of comparator 136 is slightly above the steady state output of the sensor circuit 120. Under these conditions, the comparators are in the off state and their outputs are high. As vacuum is applied to the sensor circuit 120, the output voltage will increase in a linear manner. The voltage increase is applied to the negative inputs of all eight comparator circuits of 134 and 136. As the voltage increases, the first comparator at the junction of R8 and R9 will go into conduction. As the increase continues, each of the comparators will act in a like manner. If the voltage continues to increase to its design maximum, all eight comparator circuits will be conducting. Any comparator that is conducting will have a low output. The comparators have an open collector output circuit and each is connected to the power supply 160 via an LED 138 and series current limiting resistor 139 (RP1). This condition will cause the LED connected to each individual comparator to illuminate and indicate the level of vacuum reached. The output of each comparator is also connected to a SPST switch contained in the switch bank 137 (SW1). These switches each represent one of the eight comparator circuits. The switch that is connected to the comparator representing the preselected level of vacuum at which corrective action is desired is placed in the "ON" position, and the output of the comparator is connected to the output line of the analyzer 130. In this manner, an alarm condition will be achieved whenever the preset vacuum level is attained. The single switch that is selected as the trip level will always be illuminated since the LED that corresponds to the selected level is connected to that switch and current will flow through the resistor contained in 139, the LED contained in 138, the switch contained in 137, and the input voltage clamp circuitry contained in the control circuitry 140, described hereinafter. The sensor circuit 120 and the analyzer circuit 130 require a power supply voltage that is slightly higher than that required for the control circuitry 140. This requires that the output of the analyzer circuit 130 be clamped at the maximum level of the input voltage allowed by the circuitry of the control circuit 140. A clamp diode is utilized at the input of the control circuit 150 and completes the current path that allows the illumination of the selected switch on the switch bank 137. Referring to FIG. 4, the control and relay circuitry 140 is shown, in accordance with the first preferred embodiment of the fluid vacuum safety device 50. The input signal to the control circuitry 140 is the output of the analyzer circuit 130 and is applied to an inverter 141 to generate a true or high signal under an alarm or off-normal condition. The output of the inverter 141 is connected to a three input AND gate 142. The second input to this AND gate 142 is the Q' output of the service timer 143. The service timer 143 is a 555 type timer and is set by the momentary activation of the service switch 144. When this switch 144 is activated, the set input to timer 143 starts the timer cycle. This makes the Q' output of the timer 143 FALSE and applies a FALSE to the AND gate 142. In this manner, any signal from the analyzer circuitry 130 is negated while in the service mode. When service is completed, the service person should momentarily activate the "SERVICE RESET" switch 145 which will activate the timer 143, reset circuitry, and restore normal conditions to the system. If the switch 145 is not pressed/activated, the timer 143 will time out and normal operation will be restored after a predetermined period of time. The third input to the AND gate 142 is connected to another timer 146 which is also a 555 type timer. This particular timer 146 is started when power is turned on and applied to the device 50. The Q' output of this timer 146 holds off the AND gate 142 for a short duration when the system initially starts in order to allow the pump of the fluid circulation system to reach prime. At the end of this duration, two of the AND inputs are in a true state. This is a normal operation. If an alarm condition should be encountered, the alarm input to the AND gate will go true. With all three inputs true, the output of the AND gate 142 will go true and activate the set input to the latch 147. The latch 147 remains in a set state until it is manually reset via the alarm reset switch 148. When the latch 147 is set, the relay 149 is activated and the normally closed (N/C) contacts open. This drops the power to the contactor that allows the pump of the circulation system to run. At the same time, the normally open (N/O) contacts close and provide power to operate the vacuum breaker 170 (see FIG. 5) which will allow the release of any object held to the open ends of the intake lines (return lines) leading from the reservoir W to the pump 24. Once this happens, the pump 24 cannot be restarted until the alarm reset switch 148 is activated. It should be noted at this point that the device 50 can be configured with additional relay contacts to allow the use of various warning devices and indicators which are activated at the preset vacuum pressure level (alarm condition). Referring to FIG. 5, the device 50, in accordance with the first preferred embodiment, is shown wired along with a vacuum breaker 170 to other components of a fluid circulation system. The diagram of FIG. 5 is representative of a preferred configuration of components for use in the fluid circulation system of swimming pools and hot tubs. In FIG. 5, the fluid vacuum safety device 50 is shown wired to the vacuum breaker 170 and other components. When the timer 180 of the system goes active, power is applied to the transformer 190, which supplies low voltage AC to the safety device 50. One side of the low voltage AC is also supplied to the contactor 200 and the vacuum breaker 170. If conditions are normal, the low voltage AC circuit will be completed to the contactor 200 which will allow the motor 210 of the pump 24 to run. Once the initial time period for pump start-up is complete, the safety device 50 monitors operating conditions. If an off-normal condition is encountered, the safety device 50 will break the circuit to the contactor 200 and complete the circuit to the vacuum breaker 170, thereby introducing air from atmosphere into the suction intake lines (return lines) of the system and eliminating vacuum pressure between the pump 24 and open ends of the suction intake lines. This state will be maintained until the device 50 is manually reset after the off-normal condition has been cleared. With the incorporation of additional contacts, other indicators or warning devices can be added. Referring now to the remaining drawing figures, the fluid vacuum safety device is shown in accordance with an alternative embodiment and is indicated as 50'. The safety device 50' includes a base unit 52 defined primarily by an inverted T-section formed of PVC having a main through passage 54 defined along the bottom of the inverted T and having opposite open ends 55, 55' which connect in-line to the main intake line 20, as seen in FIG. 6. During normal operating conditions, water flow will travel in the direction of the arrow 56 in the through conduit 54 towards the pump 24. The inverted T-section of the base unit 52 further includes an upwardly extending vent port 60 extending upwardly from the through passage 54, in fluid communication therewith, to a top open end 62. The top open end 62 is surrounded by an annular flange 64 having an O-ring seal 67 fitted to a top face 68. A frangible membrane 70 rests on the O-ring 67 in covering relation to the open top 62 of the vent port 60. The frangible membrane 70 may be provided with an increased thickness about its outer periphery, defining a surface engaging rim 72. The central zone 74 within the surrounding rim 72 extends across and completely covers the open top 62 of the vent port 60 and is of a reduced thickness relative to the rim 72. The frangible membrane 70, and particularly the central zone 74, may be formed of glass or other materials having shattering or disintegrating characteristics. The thickness of the central zone 74 of the frangible membrane 70 will vary depending upon both the desired predetermined negative pressure at which the frangible membrane is caused to implode and disintegrate, as well as the diameter of the opening 62 which the central zone 74 covers and the material characteristics of the membrane. Nonetheless, the central zone 74 is thin (in most instances less than 1/8" thick) and will implode and disintegrate in response to the suction force (indicated by the arrow 76) as occurs when one or more suction intakes become obstructed. The ideal vacuum pressure at which the frangible membrane 70 disintegrates is approximately 20 in. Hg. When the frangible membrane 70 is caused to disintegrate, as a result of the suction force of the vacuum condition in the through passage 54 and vent port 60, air from atmosphere is able to quickly enter through the open top 72 to fill the intake lines of the fluid circulation system, thereby eliminating the vacuum. The frangible membrane 70 is maintained in place, in covering relation to the open end 62, by a fitting 80 having a lower annular face 82 which opposes the flange 64, sandwiching the rim 72 of the frangible membrane 70 therebetween, as seen in FIG. 7. The O-ring 67 absorbs pressure to prevent the frangible membrane 70 from cracking as the fitting 80 is advanced towards the flange 64 and against the rim 72 of the frangible membrane 70. A female coupling 84 is provided to facilitate attachment of the fitting 80 to the base unit 52, enabling threaded advancement and withdrawal of the fitting 80 relative to the flange 64 and frangible membrane 70. Threads 85 about the outer periphery of the fitting 80 intermesh with corresponding threads 86 on the inner face of the female coupling 84. An inwardly directed flange 87 on the lower open end of the female coupling 84 engages the underside of the flange 64 of the vent port. The fitting 80 further includes a flat ledge 88 which proceeds inward to a reduced diameter extension 89. The fitting 80 is open at both the opposite ends and has a larger diameter between the annular face 82 compared to a top open end 90. The ledge 88 on the fitting 80 is provided with a plurality of air inlet holes 94 which extend from the top ledge 88 through the thickness of the fitting 80 to provide air flow communication between the exterior atmosphere and an inner chamber 96 above the frangible membrane 70. Once the frangible membrane 70 disintegrates, air from atmosphere enters through the air inlet holes 94 and through the top opening 62 of the vent port 60 and throughout the suction intake lines of the system to eliminate the vacuum. An electrical switching device 100 can be fitted to the fluid vacuum safety coupling 50, as shown in FIGS. 7 and 9. To facilitate attachment of the electrical switching device 100, a female coupling 102 can be fitted to the device 100 for threaded engagement with an exterior threaded surface 91 on the reduced diameter extension 89 of the fitting 80. The bottom portion of the electrical switching device 100 has a sensing assembly 104 which extends through the open end 90 of the fitting 80. The sensor assembly 104 may be provided with a plunger or rod 106 which extends downwardly so that a distal end thereof engages a top surface of the frangible membrane 70. A biasing element within the device 100 may be used to urge the plunger 106 downwardly against the frangible membrane 70. This plunger 106 serves as an indicator to the electrical switching device 100, indicating the status of the frangible membrane 70. Disintegration of the frangible membrane 70 results in further downward extension of the plunger 106, thereby activating the electrical switching device 100. The electrical switching device 100 may trigger an audible alarm housed within the device 100 and/or at a remote location via a hard wired or wireless connection. The electrical switching device 100 can further be used to shut off the pump 24. Still further, the electrical switching device 100 can be used to activate virtually any electronic component to perform a desired function once the frangible membrane 70 is shattered. While the instant invention has been shown and described in accordance with preferred embodiments thereof, representing a best mode of the invention at the time of filing of the application for patent, it is recognized that variations, modifications and changes may be made to the instant disclosure without departing from the spirit and scope of the invention, as set forth in the following claims and within the doctrine of equivalents.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an ophthalmic apparatus, and more particularly to the ophthalmic apparatus suitable for measuring a refractive power of an eye to be examined, photographing the eye, or the like. 2. Description of Related Art Conventionally, regarding a method of an alignment of an eye to be examined utilized in an ophthalmic apparatus, one widely known method is to detect or observe an image of a target projected onto a cornea of the eye to be examined, and thereby place a corneal center and the apparatus at positions having a predetermined positional relationship with respect to each other. Referring to an apparatus, for example an automatic eye refractive power measuring apparatus or the like, which projects a measurement luminous flux into the eye and detects a reflected luminous flux from a fundus of the eye with a photo-detector, it is required that the measurement luminous flux or the reflected luminous flux to pass the pupil being appropriate in size for measurement. Generally, positions of a corneal center and a pupil center of one eye approximately correspond to each other. There may be cases, however, where the deviation from each other is considerably big. In these cases, if an alignment is done with respect to the corneal center of the eye, the measurement luminous flux (the reflected luminous flux) is likely to eclipsed by an iris. Due to this eclipse, the measurement luminous flux may not be reflected, which is necessary to carry out the measurement, and measurement errors are easily to be caused. In addition, a size of a pupil varies depending on brightness of a sight and individual variation. In the case of an eye having a pupil small in size, even if the amount of deviation between the corneal center and the pupil center is relatively small, a measurement based on an alignment with respect to the corneal center easily results in errors for the same reason mentioned above. SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances and has an object to overcome the above problem and to provide an ophthalmic apparatus capable of minimizing occurrence of errors as well as obtaining highly accurate results, upon measuring an eye refractive power of the eye or photographing the eye, regardless of deviation between the corneal center and the pupil center or individual differences in pupil size. Additional objects and advantages of the invention will be set forth in part in the description which follows and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims. To achieve the objects and in accordance with the purpose of the present invention, as embodied and broadly described herein, an ophthalmic apparatus including measuring means for measuring or examining an eye to be examined utilizing reflection of a luminous flux projected into the eye through a pupil, the ophthalmic apparatus comprises moving means for moving the measuring means relative to the eye, target projecting means for projecting an alignment target onto a cornea of the eye, target detecting means for detecting an image of the alignment target, photographing means for photographing an image of an anterior part of the eye, pupil position detecting means for detecting a position of the pupil by signals transmitted from the photographing means, judging means for determining a reference point for alignment based on information on the position of the pupil detected by the pupil position detecting means and the image of the alignment target detected by the target detecting means and instructing means for giving instructions for making the moving means move based on the reference point determined by the judging means. In another aspect of the present invention, an ophthalmic apparatus including measuring means for measuring or examining an eye to be examined utilizing reflection of a luminous flux projected into the eye through a pupil, the ophthalmic apparatus comprises target projecting means for projecting an alignment target onto a cornea of the eye, target detecting means for detecting an image of the alignment target, photographing means for photographing an image of an anterior part of the eye, pupil position detecting means for detecting a position of the pupil by signals transmitted from the photographing means, measurement area defining means for defining a partition of an area necessary for measurement or examination based on the image of the alignment target detected by the target detecting means, calculating means for calculating coordinates where a dividing line of the area necessary for measurement or examination defined by said measurement area defining means crosses a periphery of the pupil detected by the pupil position detecting means, and judging means for determine whether or not the area necessary for measurement or examination is within the range of the pupil in accordance with vales calculated by the calculating means. According to the present invention, even in a case of the eye to be examined of which alignment with respect to the corneal center may not be carried out due to the pupil condition, an alignment can be done with reference to the pupil position, and occurrence of measurement errors can be minimized. Therefor, even an inexperienced operator can easily perform an alignment without judging the pupil condition. Furthermore, referring to an apparatus for performing automatic alignment without an examiner, that a measurable area can be extend benefits an examinee. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with the description, serve to explain the objects, advantages and principles of the invention. In the drawings, FIG. 1 is an overview of an automatic eye refractive power measuring apparatus of the preferred embodiment of the present invention; FIG. 2 is a view showing a schematic configuration of an optical system and a controlling system of the preferred embodiment of the present invention; FIG. 3 is a flowchart for describing operations of the apparatus upon automatic alignment; FIG. 4 is a view illustrating the way to define an area necessary for measurement and the way to determine wether or not the area is within a range of a pupil; FIG. 5 is a view showing an example of a case where the area necessary for measurement is not within the range of the pupil due to the deviation between the corneal center and the pupil center; FIG. 6 is a view showing a variation to obtain the direction toward the pupil center; and FIGS. 7 is a view illustrating judgement based on the image of the alignment target and the position of the pupil. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A detailed description of one preferred embodiment of an ophthalmic apparatus embodying the present invention will now be given referring to the accompanying drawings. FIG. 1 is an overview of an automatic eye refractive power measuring apparatus of the preferred embodiment of the present invention. Reference numeral 1 denotes a base provided with a face support unit 2 for supporting an examinee's face. 3 is a body and 4 is a measuring part containing an optical system as hereinafter described. 5 denotes a joystick for moving the body 3 and the measuring part 4. Responding to operations of the joystick 5, the body 3 slides along a horizontal plane of the base 1 in Z direction (back and forth direction) as well as in X direction (side to side direction). Responding to operations of a rotation knob 5a, the measuring part 4 moves in Y direction (up and down direction) relative to the body 3. In addition, the measuring part 4 is adjustable in X, Y and Z directions with respect to the body 3 so as to be operable upon automatic alignment. 6 denotes a TV monitor for displaying an image of an eye to be examined and information to be provided for an examinee. Next, a schematic configuration of the optical system and a controlling system of the apparatus will be described with reference to FIG. 2. <optical system> Reference numeral 10 denotes a measurement optical system. 11 denotes two light sources for measurement having their wavelength within a near infrared range which are arranged to be rotatable on an optical axis L1. 12 denotes a condenser lens, 13 denotes a movable target plate provided with a spot aperture, 14 denotes a projecting lens, 15 denotes a beam splitter, 20 denotes an object lens, 21 denotes another beam splitter, and 22 denotes a relay lens. 23 denotes a strip-shaped corneal reflection eliminating mask which is disposed at a conjugate position with respect to a cornea of the eye E. 24 denotes another relay lens, 25 denotes a moving lens which moves along with the target plate 13, 26 denotes an image forming lens and 27 denotes a photo-detector for measurement which rotates about an optical axis being synchronized with the light sources 11 and the corneal reflection eliminating mask 23. Reference numeral 30 denotes a fixation target optical system. 31 is a dichroic mirror and 32 is a first relay lens which is capable of moving horizontally on the optical axis, and by this movement, the first relay lens 32 fogs the eye E. 33 is a second relay lens, 34 is a fixation target which is positioned at a focal point of the second relay lens 33, 35 is a condenser lens, and 36 is an illumination lamp. Reference numeral 45 denotes a front target projecting optical system for projecting an alignment target from the direction of the visual line of the eye E. A point light source 46 emits a near infrared ray, and the near infrared ray successively passes through a rely lens 47, the dichroic mirror 31, the beam splitter 21 and the object lens 20, thereby made to be approximately parallel, then to be reflected at the beam splitter 15 so as to project an alignment target on the eye E for alignment in up and down direction as well as in side to side direction. Reference numeral 40 denotes a target projecting optical system for detecting a working distance. The target projecting optical system 40 is provided with a pair of first target projecting optical systems 40a and 40b, and another pair of second target projecting optical systems 40c and 40d. The first target projecting optical systems 40a and 40b are arranged to be symmetrical to each other with respect to the optical axis L1, and the second target projecting optical systems 40c and 40d are, likewise, arranged to be symmetrical to each other with respect to the optical axis L1, but with a smaller angle relative to the eye E than that of the first target projecting optical systems 40a and 40b. The first target projecting optical systems 40a and 40b which include point light sources 41a and 41b for emitting near infrared rays, spot apertures 42a and 42b and collimator lenses 43a and 43b, project alignment targets of infinite distance onto the eye E by utilizing the luminous flux which are approximately parallel. On the other hand, the second target projecting optical systems 40c and 40d which include point light sources 41c and 41d for emitting near infrared rays, project alignment targets of finite distance by utilizing a divergent ray. 50 is an observing/target detecting optical system for observing an anterior part of the eye E and for detecting the alignment targets. The images of the alignment targets formed on the eye E as well as an image of the anterior part of the eye E illuminated by a near infrared ray emitted from a light source for illuminating anterior part of the eye E (not illustrated) are reflected at the beam splitter 15, pass through an object lens 51 and a mirror 52, so as to be photographed by a CCD camera 53. <controlling system> Output signal from the CCD camera 53 is digitized by an A/D converter 71, then captured by a flame memory 73. Having passed through a D/A converting circuit 74 and an image synthesizing circuit 75, the captured image is to be displayed on the TV monitor 6 in real time. Numeral reference 76 is a display circuit for generating alignment marks, graphics, textual information, and the like. Signals from the display circuit 76 is synthesized with picture signals from the CCD camera 53 in the image synthesizing circuit 75 so as to be displayed on the TV monitor 6. 77 denotes an image processing part to conduct predetermined processes to the images captured into the frame memory 73. A controller 70 detects a position of the image of the alignment target as well as a position of the pupil of the eye E under signals from the image processing part 77. Reference numeral 60 denotes an X driving system for moving the measuring part 4 in X direction relative to the body 3, 61 denotes a Y driving system for moving the same in Y direction, and 62 denotes a Z driving system for moving the same in Z direction. Each of the driving systems is composed of a motor, a motor driving circuit, and the like. Hereinafter, operations of the apparatus having above-described configuration at the time of performing automatic alignment will be described. (See FIG. 3, the flow chart) First, an examiner carries out a rough alignment by utilizing the joy stick 5 or the like with observing the TV monitor 6. Once the rough alignment is done and five target images, formed by the front target projecting optical system 45 and the target projecting optical system for detecting a working distance 40, are photographed by the CCD camera 53, the controller 70, under signals from the image processing part 77, extracts a target image 101 formed by the front target projecting optical system 45, and detects alignment conditions in terms of XY directions with reference to the detected image (that is to say with reference to the corneal vertex). To detect alignment conditions in terms of Z direction, the distance between target images 102a and 102b formed by the first target projecting optical systems 40a and 40b and the distance between target images 102c and 102d formed by the second target projecting optical systems 40c and 40d are to be compared. This is to utilize the characteristics of images of corneal reflection formed by an infinite-distance light and a finite-distance light. The height of an image of the corneal reflection formed by an infinite-distance light remains the same even if the working distance changes, while the height of an image of the corneal reflection formed by a finite-distance light varies responding to the change in the working distance (for the details of this relationship, see U.S. Pat. No. 5,463,430 corresponding to Japanese Patent Laid-Open No. HEI 6-46999). The controller 70 triggers each of the driving systems on the basis of the alignment information obtained by detecting the targets, and moves the measuring part 4 in each direction to make alignment adjustment. Once respective alignment conditions in X, Y and Z directions are within predetermined acceptable ranges, the controller 70 stops each driving system. After confirming that the alignment conditions in X and Y directions, judging from the target image 101, are within the predetermined acceptable range, the controller 70 judges whether or not the measurement luminous flux can pass through the pupil of the eye E. Hereinafter, the method of judging whether or not the measurement luminous flux can pass through the pupil of the eye E will be described. First, how to define a measurement area necessary for measurement will be mentioned. As an example, let the measurement area be a rectangle area 110 which is a square area surrounded by horizontal lines of M1 and M2 and vertical lines of M3 and M4. The measurement area actually required for measurement is a circle area. However, as long as the rectangle area 110 is defined to be tangent internally or externally to the circle area, it should be regarded as equal when making judgement whether or not the measurement luminous flux can pass through the pupil of the eye E. Besides, to define the measurement area as a rectangle area is advantageous for signal processing in terms of memory. To set the horizontal lines of M1 and M2 and the vertical lines of M3 and M4 which define the rectangle area, given that the diameter which the measurement optical system requires is 2.5 mm, the X and Y coordinates of respective lines are to be on the lines corresponding to ±11.25 mm from the optical axis L1. Next, the method of judging whether or not the rectangle area necessary for measurement is within the range of the pupil of the eye E will be described. As shown in FIG. 4, the coordinates at which the horizontal lines M1 and M2 respectively cross peripheries of the pupil 100 shall be P1, P2 and P3, P4. Likewise, the coordinates at which the vertical lines M3 and M4 respectively cross peripheries of the pupil 100 shall be P5, P6 and P7, P8. If the X coordinates of P1-P8 satisfy the condition given in the following expression, the rectangle area 110 can be regarded to be within the range of the pupil of the eye E. Although the Y coordinates of P1-P8 are not mentioned herein, it is also possible to make judgements with respect to the Y coordinates in a like manner. P1≦P5<P7≦P2, and P3≦P6<P8≦P4 (expression 1) Even in the case where the pupil diameter is relatively large, thus the pupil is partially covered by an upper eyelid, the coordinates of P5 and P7 are to be treated likewise in the same manner. Furthermore, each of the coordinates can be obtained easily by fetching horizontal and vertical waveform from picture signals stored in the frame memory 73 and signal processing of differential processing or the like. Upon the detection, when each image of the corneal reflection interferes with the detection as picture noise, each point light source is to be turned on and off in turn and the timing of the target detection and the pupil position detection is to be staggered, so that each image can be easily distinguished from the other. When the alignment based on the target image 101 (the confirmation that the alignment conditions in X and Y directions, judging from the target image 101, are within the predetermined acceptable range) is completed, and the alignment condition allows the measurement luminous flux to pass though the pupil, the controller 70 automatically executes (starts) the measurement. On the contrary, if there is a deviation between the corneal center and the pupil center, and therefore the condition given in the above-mentioned expression (1) is not satisfied, as shown in FIG. 5 (target images are not illustrated therein), it is regarded that the alignment is not under acceptable condition for the measurement luminous flux to pass though the pupil. Accordingly, further alignment adjustment in X and Y directions is to be made with reference to the pupil position in order to bring the rectangle area 110 within the range of the pupil 100. In order to carry out this alignment, a direction in which the measuring part 4 is to be shifted is first to be obtained. For higher accuracy in measurement results, it is preferred that the deviation from the corneal center is as small as possible. For this reason, the rectangle area 110 (the optical axis L1) is made to be shifted toward the pupil center 111, yet kept within the range of the pupil 100. The coordinates of the pupil center 111 can be calculated from the coordinates of P1-P8 obtained in the aforementioned way; the X coordinates is obtained by seeking the center of the X coordinates of P1 and P2, or P3 and P4, and the Y coordinate is obtained by seeking the center of the Y coordinates of P5 and P6, or P7 and P8. After having obtained the coordinates of the pupil center 111, the controller 70 drives the measuring part 4 (the optical axis L1) in X and Y directions toward the coordinates of the pupil center 111. As the apparatus regularly (at a fixed intervals) monitors whether the aforementioned rectangle area 110 is within the range of the pupil 100, once it is judged that the rectangle area 110 is within the range of the pupil 100, the apparatus stops the moving the measuring part 4 in X and Y directions and finishes the alignment. Thereafter, the measurement is to be executed. As described above, it can be managed to bring the rectangle area 110 within the range of the pupil 100 in cases where the pupil diameter is relatively bigger than the rectangle area 110. On the contrary, when the pupil has a diameter smaller than the predetermined rectangle area 110, the condition given in the expression (1) can not be fulfilled. In such a case, when the pupil center 111 and the optical axis L1 are overlapped within a predetermined acceptable area, the movement in X and Y directions is made to be stopped, and the alignment is to be completed. Thereafter the measurement is to be started. Next, an eye refractive power measurement will be mentioned. The measurement luminous flux emitted from the light sources 11 successively passes through the target plate 13, the projecting lens 14 and the like. After having been converged in the vicinity of the cornea, the measurement luminous flux reaches the fundus of the eye E. The target image reflected at the fundus of the eye E is passed through the area of the pupil necessary for the measurement and to be formed on the photo-detector 27 by successively passing through the object lens 20, the beam splitter 21, the relay lens 22, the corneal reflection eliminating mask 23, the relay lens 24, the moving lens 25 and the image forming lens 26. In case that the eye E has ametropia, the controller 70 moves the moving lens 25 as well as the target plate 13 to conjugate positions relative to the fundus of the eye E based on the signal of reflected luminous flux received by the photo-detector 27. Next, the controller 70 moves the first relay lens 32 so as to place the fixation target 34 and the fundus of the eye E at conjugate positions with respect to each other and further moves the first relay lens 32 so that appropriate amount of diopter is to be fogged. At this stage, the light sources 11 and the photo-detector 27 and the like are made to be rotated around the optical axis. During the rotation, in response to the signals from the photo-detector 27, the target plate 13 and the moving lens 25 are made to be moved. By detecting the amount of this movement, values of the refractive power in respective meridian directions are obtained, and by conducting predetermined processes to these values, the refractive power of the eye E can be obtained. In some cases of the eye E, the measurement luminous flux may not satisfactory pass through the pupil of the eye if an alignment is made on the corneal center. Even in these cases, however, the measurement results can be obtained with reducing occurrence of measurement errors by performing an alignment in accordance with the aforementioned method; that is to say by bringing the area necessary for measurement into the range of the pupil. In addition, the method increases the possibility of achieving a measurement result when the pupil of the eye E is relatively smaller than the area necessary for the measurement. It should be noted, however, that the measurement results obtained in this way naturally includes errors in some degrees comparing with an eye refractive power based on the measurement results obtained by the alignment on the corneal center. Yet, to obtain the measurement results serves some functions. For example, when prescribing spectacles by performing a subjective examination, the measurement results, despite errors it contains, will be helpful information to make a first selection of a degree of a spectacle lens. In case that alignment is made, not on the center of the cornea but on a deviated position therefrom, it can be displayed along with the measurement results, so that an examiner becomes aware that the measurement results includes errors in some degrees. Although an automatic alignment has been mentioned above, if the automatic alignment is not to be carried out, a guide mark, such as an arrow or the like, is to be displayed on the TV monitor 6 for bringing the area necessary for a measurement into the range of the pupil. When the alignment is completed, the examiner is to be informed of the completion of the alignment. In the alignment method described above, the coordinates of the pupil center is to be calculated, thereafter the measuring part 4 is guided (given directional instructions) thereto. Applying the following variation is also possible. As shown in FIG. 6, by utilizing picture information captured in the frame memory 73, a horizontal line M5 and a vertical line M6 are to be detected; each of the lines crosses a periphery of the pupil at a closer point (or two points having a predetermined interval therebetween) to the target image 101 (the center of the cornea) than the other horizontal or vertical line crosses a periphery of the pupil. Thereby, calculate each amount of the deviation Δx, Δy from the optical axis L1. The gradient of the line which connects the optical axis L1 and the pupil center 111 is given in the following expression, so that the direction from the optical axis L1 toward the pupil center 111 can be acquired. -Δx/Δy The measuring part 4 is to be moved along the acquired direction in X and Y directions respectively. Once it is judged that the rectangle area 110 is within the range of the pupil 100, adjustment in X and Y directions is made to be stopped and the alignment is to be completed. If the pupil diameter is relatively smaller than the rectangle area 110, movement in Y direction is to be stopped at a point where the interval between P1 and P2 is approximately equal to the interval between P3 and P4. Likewise movement in X direction is to be stopped at a point where the interval between P5 and P6 is approximately equal to the interval between P7 and P8, thereafter the alignment is completed. That is to say, in case of that the pupil diameter is relatively small, alignment is made approximately on the pupil center. Upon guiding the measuring part 4, it is also possible to guide the measuring part 4 in accordance with the judgement whether or not the measurement luminous flux can pass through the pupil based on an alignment condition of the target image 101 before the time when the alignment based on the target image 101 (the corneal vertex) is completed. That is to say, even before aligning the optical axis L1 to the target image 101 (the corneal vertex), as shown in FIG. 7, an area with the center at the target image 101 surrounded by horizontal lines M1' and M2', and also vertical lines M3' and M4' to be defined as the rectangle area 110'. Whether the rectangle area 110' is within the range of the pupil 100 or not is judged by whether or not the coordinates of P1'-P8', where the horizontal lines M1' and M2', and also the vertical lines M3' and M4' respectively cross periphery of the pupil 100, satisfy the aforementioned expression (1). When it is judged that the rectangle area 110' is not within the range of the pupil 100, the pupil center 111' is to be calculated from the coordinates P1'-P8' just as in the aforementioned manner. When moving the center of the rectangle area 110' toward the pupil center 111' on the line therebetween, a position at which the rectangle area 110' comes into the pupil 100 (the center of the rectangle area 110') is to be calculated (by simulating the coordinates P1'-P8' upon the movement of the center of the rectangle area 110' toward the pupil center 111'). The alignment is completed when the optical axis L1 and the calculated center of the rectangle area 110' come to approximately the same position by moving the calculated center of the rectangle area 110' toward thereto. If the pupil of the eye E is smaller than the rectangle area 110', the center of the rectangle area 110' is to be moved toward the pupil center 111' instead. By this operation, movement of the measuring part 4 can be smoothly made, and therefore, the time spent on alignment is shortened. In case that an examiner performs alignment manually, marks corresponding to objects to which movement is to be made are to be displayed on the TV monitor 6, so that the examiner can easily carry out the alignment (it will be easier to distinguish those marks from the target images and the like, if they are displayed in color). In the preferred embodiment described above, the target for the alignment in X and Y directions is formed on the optical center of the cornea by projecting the approximately parallel luminous flux from the front side of the eye E. However, it is also possible to adopt a method, as in a cornea curvature measuring apparatus, to project ring patterns on the cornea of the eye E utilizing a divergent light. The optical center of the cornea can be calculated from the image of the ring patterns Based on the relationships between the corneal center calculated thereof and the positions of the pupil, alignment adjustment can be made. However, it should be noted that according to this method, there exist a slight deviation between the center of the ring patterns and the optical center of the cornea along with X and Y movement. The center of the cornea is to be calculated after having conducted corrective processes for this deviation. The foregoing description of the preferred embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in the light of the above teachings or may be acquired from practice of the invention. The embodiments chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention generally relates to synthesis of synthetic layered silicates. More particularly, this invention generally relates to the production of a synthetic layered silicate that may develop acceptable rheological properties in aqueous solutions in the presence of relatively high levels of electrolytes or surfactants. [0003] 2. Description of the Related Art [0004] The name “hectorite” has been ascribed to a natural trioctahedral smectite found at Hector, Calif., U.S.A. The synthesis of synthetic layered silicates similar to natural hectorite has been described by Granquist and Pollack in “Clays and Clay Minerals”, Volume 8, Proceedings of the 8th National Conference on Clays and Clay Minerals, Pages 150-169, which is incorporated herein by reference. In the process described by Granquist, gels of magnesium hydroxide and of silica are produced separately, washed, and combined and redispersed in water to form a suspension. Lithium hydroxide or lithium fluoride and sodium hydroxide are added to the suspension which is then treated hydrothermally by refluxing the suspension with stirring until a product having a crystal structure similar to that of hectorite is formed. [0005] While synthetically produced layered silicates may have a crystal structure similar to natural hectorite, they may not have good rheological properties. Measuring the Bingham Yield Value of an aqueous dispersion of a substance may provide a standard comparator of the rheological properties between substances. The term Bingham Yield Value, also known as Bingham Yield Stress, is referred to in standard works on rheology. References to Bingham Yield Value may be found in “Rheology Theory and Applications”, F. R. Eirich, Acad. Press, Volume 1, 1956, page 658; “Colloidal Dispersions”, L. K. Fischer, N. Y. Bureau of Standards, 2nd Edition, 1953, pages 150-170 and “The Chemistry and Physics of Clays and other Ceramic Materials”, 3rd Edition, page 463, A. B. Searle and R. W. Grimshaw, all of which are incorporated herein by reference. [0006] The Bingham Yield Value may be determined by first obtaining a flow curve relating the shear stress to the rate of shear. The straight-line section of the curve is extrapolated to the shear stress axis. The intercept at the shear stress axis is the Bingham Yield Value. The Bingham Yield Value may conveniently be determined on any viscometer capable of measuring a range of shear rates and shear stresses. [0007] Some synthetic layered silicates, when dispersed in amounts of about 2 grams of silicate in 100 ml of tap water, may produce a Bingham Yield Value of only about 15 dynes/cm 2 . This Bingham Yield Value may be lower than the Bingham Yield Value produced by natural hectorite at similar addition rates. The static gel strength produced by the synthetic layered silicates may also be lower than the static gel strength produced by natural hectorite. [0008] Processes for the production of synthetic layered silicates having a crystal structure similar to natural hectorite, but which may have better rheological properties in tap water than natural hectorite have been described in British Patent Nos. 1,054,111; 1,213,122; 1,432,770 and U.S. Pat. Nos. 3,586,478; 3,671,190; 3,954,943 and 4,049,780, all of which are incorporated herein by reference. These processes describe the production of synthetic layered silicates having a characteristic hectorite-like structure and having varying contents of lithium and fluorine. The synthetic layered silicates may be produced by a process involving direct co-precipitation of a magnesium silicate. [0009] British Patent No. 1,054,111 describes a process for producing a synthetic clay product. Magnesium ions, silicon (as silicate), hydroxyl, and sodium ions are added to a heated and stirred aqueous solution of lithium and fluoride ions. The co-precipitation reaction forms a slurry. The resulting precipitate is treated by heating the solution to reflux. The concentration of the product in the slurry is from 1% to 8% by weight. The synthetic layered silicate includes fluorine and lithium. [0010] The process described in British Patent No. 1,213,122 involves precipitating a magnesium silicate by combining an aqueous solution of a water soluble magnesium salt with an aqueous alkaline solution of one or more sodium compounds in the presence of a dissolved silicon compound, and heating the precipitate under pressure. The concentration of the precipitate is preferably not more than 5% by weight. The synthetic layered silicate product includes no fluoride ions and optionally includes lithium ions. [0011] The process described in British Patent No. 1,432,770 involves precipitating a magnesium silicate by combining an aqueous solution of a water soluble magnesium salt with an aqueous sodium carbonate solution, followed by addition of a dissolved silicon compound and heating the precipitate. The concentration of the precipitate is preferably 5% to 10% by weight. The synthetic layered silicate product may include either lithium or fluorine or both. [0012] The products of the processes of the three British patents set forth above, are also characterized by producing dispersions giving exceedingly high Bingham Yield Values in excess of any known to be produced by natural hectorite dispersions and usually above 40, for example from about 50 to 250 dynes/cm 2 as a 2% by weight dispersion in tap water, and high static gel strength. [0013] Certain products may produce acceptable viscosities in tap water, but it may be desirable to produce a synthetic layered silicate with acceptable rheological properties in aqueous solutions containing higher levels of electrolytes than tap water. SUMMARY OF THE INVENTION [0014] In an embodiment, the synthesis of a synthetic layered silicate may be produced having a crystal structure similar to hectorite and having the general formula: [Si 8 (Mg a Li b )O 20 (OH) 4−y F y ] z− zM + [0015] wherein a=4.75 to 5.45; b=0.25 to 1.25; y=0 to <4; z=12-2a-b; and M is Na + or Li + . [0016] In an embodiment, a lithium compound may be added to water followed by addition of a water-soluble magnesium compound. The aqueous mixture may be heated to above ambient temperature and gently stirred. A soluble carbonate solution may be added to the lithium and magnesium mixture with stirring. Magnesium carbonate may begin to precipitate. Subsequently, a soluble silicate solution may be added to the mixture. The resulting solution and precipitate may be stirred and hydrothermally treated for a selected time period to produce suitable crystal growth. Hydrothermal treatment may be defined as heating the solution to at least the boiling point of the solution, capturing the vapor, condensing the vapor and returning the condensate to the solution. An autoclave may be used in hydrothermal treatment. The resulting precipitate may be filtered, dried, and ground. [0017] In an embodiment, a magnesium compound may be dissolved in water. An aqueous solution of a carbonate compound may be added to the magnesium compound. Magnesium carbonate may begin to precipitate. Compounds providing sources of lithium and/or fluoride ions may be added to the magnesium carbonate suspension. A silicate solution may be added to the magnesium carbonate suspension. The resulting solution and precipitate may be stirred and hydrothermally treated for a selected time period to produce suitable crystal growth. An autoclave may be used in hydrothermal treatment. The resulting precipitate may be filtered, dried, and ground. [0018] Other embodiments are set forth in the description below or in the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0019] [0019]FIG. 1 is a graph showing the electrolyte tolerance of a synthetic layered silicate material produced by an embodiment. DETAILED DESCRIPTION OF THE INVENTION [0020] In an embodiment, a synthetic layered silicate may be synthesized having the following formula: [Si 8 (Mg a Li b )O 20 (OH) 4−y F y ] z− zM + [0021] wherein a=4.75 to 5.45; b=0.25 to 1.25; y=0 to <4; z=12-2a-b; and M is Na + or Li + . [0022] A water-soluble lithium compound may be added to an amount of water. A water-soluble lithium compound may be any soluble or slightly soluble lithium compound that provides a source of lithium cation when dispersed in an aqueous media. Examples of lithium compounds include, but are not limited to, lithium carbonate, lithium chloride, lithium bromide, lithium fluoride, lithium sulfate, or mixtures thereof. An excess of lithium ion content in the reaction mixture may be important in producing a synthetic layered silicate with improved electrolyte tolerances. The lithium compound may be added in amounts such that the lithium content in solution may be from about 100% to about 300% above the value of the lithium content required to provide the cation of the layered silicate. The lithium cations may be incorporated into the lattice structure of the produced layered silicate. In one embodiment, the lithium content in the produced synthetic layered silicate may be from about 0.3% to about 2.2%. In an embodiment, the lithium content, in the produced synthetic layered silicate, may be from about 0.35% to about 1.0%. In other embodiments, the lithium content, in the produced synthetic layered silicate, may be from about 0.5% to about 0.85%. [0023] Various amounts of reactants, expressed as ranges of atomic ratios, may be used to produce a synthetic layered silicate. An atomic ratio relative to lithium, wherein lithium is 1, may be about 1-10 atoms silicon, about 1-8 atoms magnesium and about 2-16 atoms sodium. In an embodiment, the atomic ratio may be about 2-5 atoms silicon, about 1-6 atoms magnesium, and about 2-14 atoms sodium, all with respect to lithium. In an embodiment, the atomic ratio may be about 3-5 atoms silicon, about 1-4 atoms magnesium, and about 2-7 atoms sodium, all with respect to lithium. Experimental results indicate that a synthetic layered silicate produced using atomic ratios in the aforementioned atomic ratios exhibit improved tolerance to electrolytes during use. Electrolytic tolerance may be measured by adding the synthetic layered silicate to an electrolytic solution and determining the viscosity of the solution. An improved tolerance to electrolytes is characterized by a viscosity greater than 100,000 centipoise (cps) in the presence of up to about 10 meqs. of electrolyte per gram of the synthetic layered silicate. [0024] The lithium compound may be stirred in the aqueous medium up to about 2 hours at about ambient temperature. The solution may be stirred during the reaction period at rates below about 1000 rpm, however, in other embodiments, the stirring rate may be below about 200 rpm. An additional amount of water may be added to the lithium mixture, followed by the addition of a water-soluble magnesium compound. The magnesium compound may be any water-soluble magnesium compound that may provide a source of magnesium cations when dispersed in an aqueous media. Examples of magnesium compounds include, but are not limited to, magnesium sulfate heptahydrate, magnesium chloride, magnesium nitrate, magnesium bromide, or mixtures thereof. The mixture may then be heated to greater than ambient temperature. [0025] In a separate container, a solution of a water-soluble carbonate compound may be prepared. The water-soluble carbonate compound may be any carbonate compound that may provide a source of carbonate anions when dispersed in an aqueous media. Examples of carbonate compounds include, but are not limited to, sodium carbonate, potassium carbonate, lithium carbonate, or mixtures thereof. The carbonate solution may be added to the aqueous mixture of the magnesium and lithium compounds. The carbonate solution may be added over a period of up to about 1 hour. The temperature may be maintained at greater than about 25° C. during addition. A silicate solution may be added to the magnesium, lithium, and carbonate solution. [0026] The silicate solution may be added to the above mixture over a period of greater than about 30 minutes, while maintaining the mixture temperature at greater than about 25° C. The silicate solution may be any solution which provides SiO 2 . The silicate solution may be added to the magnesium, lithium, and carbonate solution such that, in the produced synthetic layered silicate, in an embodiment, the ratio of SiO 2 /MgO may be from about 2.20 to about 2.50, however, in other embodiments the ratio may be from about 2.25 to about 2.40. In some embodiments, the SiO 2 /MgO ratio may be from about 2.3 to about 2.35. Examples of silicate solutions include, but are not limited to, aqueous mixtures of sodium silicate, silicic acid, lithium silicate compounds, potassium silicate compounds, mixtures of silicon dioxide and sodium oxide solutions (i.e. water glass), or mixtures thereof. [0027] The solution and product may be heated to the point wherein a vapor may be produced, the vapor condensed, and returned to the solution. The heating procedure may continue for longer than about 1 hour. Subsequently, the solution may be heated to greater than about 100° C. for a period greater than about 2 hours. An autoclave may be used. The resulting hydrous magnesium silicate may be separated by filtration, and subsequently washed and dried. [0028] In an embodiment, other orders of addition of reactants or other reactants may be utilized to produce a layered silicate compound. The same types of solutions as in the aforementioned embodiments may be utilized. An aqueous solution of a carbonate compound may be added to an aqueous solution of a magnesium compound. The carbonate compound solution may be added to the magnesium compound solution over a time period greater than about 30 minutes. The reaction solution may be maintained at a temperature greater than about 25° C. The solution may be stirred during the reaction period at rates below about 1000 rpm. In other embodiments, the stirring rate may be below about 200 rpm. Magnesium carbonate may be subsequently produced. A source of lithium and/or fluoride ions may be added to the stirred suspension of magnesium carbonate. Fluoride compounds, as the source of the fluoride ion, include, but are not limited to, lithium fluoride, sodium hexafluorosilicate, hydrofluoric acid, sodium fluoride, potassium fluoride, or mixtures thereof. An excess of lithium ion content in the reaction mixture may be important in producing a synthetic layered silicate with improved electrolyte tolerances. The lithium compound may be added in amounts such that the lithium content in solution may be from about 100% to about 300% above the value of the lithium content required to provide the cation of the layered silicate. The lithium cations may be incorporated into the lattice structure of the produced layered silicate. The lithium content, in the produced synthetic layered silicate may, in some embodiments, be from about 0.3% to about 2.2%. In an embodiment, the lithium content, in the produced synthetic layered silicate, may be about 0.35% to about 1.0%, and in other embodiments, the lithium content, in the produced synthetic layered silicate, may be about 0.5% to about 0.85%. [0029] A silicate solution, in some embodiments, may be added to the suspension of the precipitated magnesium carbonate such that, in the produced synthetic layered silicate, the ratio of SiO 2 /MgO may be from about 2.20 to about 2.50. In some embodiments, the SiO 2 /MgO ratio may be about 2.25 to about 2.40. In other embodiments, the SiO 2 /MgO ratio may be about 2.3 to about 2.35. Examples of silicate solutions include, but are not limited to, aqueous mixtures of sodium silicate, silicic acid, lithium silicate compounds, potassium silicate compounds, mixtures of silicon dioxide and sodium oxide solutions (i.e., water glass), or mixtures thereof. [0030] In an embodiment, the entire aqueous suspension from which the precipitate may be formed may be subjected to a hydrothermal treatment. The hydrothermal treatment may be conducted such that the entire aqueous suspension may be heated for a period of greater than about 1 hour at temperatures greater than about 100° C. An autoclave may be used. The material may be filtered, washed, and dried. [0031] In an embodiment, a carbonate solution may be added to the magnesium solution over a period of greater than about 30 minutes. A silicate solution may be added to the magnesium and carbonate solution, followed by the addition of the lithium and/or fluoride compounds. In an embodiment, the amount of silicate solution added to the suspension of the precipitated magnesium carbonate may be such, that in the produced synthetic layered silicate, the ratio of SiO 2 /MgO may be from about 2.20 to about 2.50. In an embodiment, the ratio of SiO 2 /MgO, in the produced synthetic layered silicate, may be about 2.25 to about 2.40. In other embodiments, the SiO 2 /MgO ratio, in the produced synthetic layered silicate, may be about 2.3 to about 2.35. The lithium compound may be added in amounts such that the lithium content in solution may be from about 100% to about 300% above the value of the lithium content required to provide the cation of the layered silicate. The lithium content, in the produced synthetic layered silicate, in some embodiments, may be from about 0.3% to about 2.2%. In an embodiment, the lithium content, in the produced synthetic layered silicate, may be about 0.35% to about 1.0%. In other embodiments, the lithium content, in the produced synthetic layered silicate may be about 0.5% to about 0.85%. The reaction solution may be maintained at a temperature greater than about 25° C. The solution may be stirred during the reaction period at rates below about 1000 rpm and, in other embodiments, at rates below about 200 rpm. The entire aqueous suspension in which the precipitate may be formed may be subjected to a hydrothermal treatment. The hydrothermal treatment may be conducted such that the entire aqueous suspension may be heated for a period of greater than about 1 hour at temperatures greater than about 100° C. An autoclave may be used. The material produced may be filtered, washed, and dried. [0032] A synthetic layered silicate may be prepared using magnesium carbonate as a starting material, rather than generating magnesium carbonate during the manufacturing process. In an embodiment, a water-soluble lithium compound may be added to an amount of water under the same conditions as previously described. The magnesium carbonate may be added to the lithium compound solution. A silicate solution amount may be added such that the SiO 2 /MgO ratio, in the produced synthetic layered silicate, may be from about 2.20 to about 2.50. In an embodiment, the silicate solution amount may be added such that the SiO 2 /MgO ratio, in the produced synthetic layered silicate, may be from about 2.25 to about 2.40. In other embodiments, the silicate solution amount may be added such that the SiO 2 /MgO ratio, in the produced synthetic layered silicate, may be from about 2.3 to about 2.35. The mixture may be processed as described herein. [0033] In an embodiment, an acid toilet bowl cleaner may be produced with a synthetic layered silicate as described herein. An acid toilet bowl cleaner formulation may include water, a synthetic layered silicate, a polymer, an acid, and surfactants. Surfactants may be provided to wet the surface of the bowl quickly and assist in cleaning performance. Non-limiting examples of suitable nonionic surfactants that may be used in an embodiment are as follows: [0034] (1) The polyethylene oxide condensates of alkyl phenols. These compounds include the condensation products of alkyl phenols having an alkyl group with about 6 to 12 carbon atoms in either a straight chain or branched chain configuration with ethylene oxide, the ethylene oxide being present in an amount equal to 5 to 25 moles of ethylene oxide per mole of alkyl phenol. The alkyl substituent in such compounds may be derived, for example, from polymerized propylene, diisobutylene and the like. Examples of compounds of this type include nonyl phenol condensed with an average of 9.5 moles of ethylene oxide per mole of nonyl phenol; dodecylphenol condensed with an average of 12 moles of ethylene oxide per mole of phenol; dinonyl phenol condensed with an average of 15 moles of ethylene oxide per mole of phenol; and diisooctyl phenol condensed with an average of 15 moles of ethylene oxide per mole of phenol. [0035] (2) The condensation products of aliphatic alcohols with about 1 to about 25 moles of ethylene oxide. The alkyl chain of the aliphatic alcohol may either be straight or branched, primary or secondary, with about 8 to about 22 carbon atoms. A 12-15 carbon alcohol may be ethoxylated with an average of 3-15 moles of ethylene oxide. Examples of such ethoxylated alcohols include, but are not limited to, the condensation product of myristyl alcohol condensed with an average of 10 moles of ethylene oxide per mole of alcohol; the condensation product of an average of 9 moles of ethylene oxide with coconut alcohol (a mixture of fatty alcohols with alkyl chains varying in length from about 10 to 14 carbon atoms); and the condensation product of undecanol with an average of about 7 moles of ethylene oxide. [0036] (3) The condensation products of ethylene oxide with a hydrophobic base formed by the condensation of propylene oxide with propylene glycol. The hydrophobic portion of these compounds may have a molecular weight of from about 1500 to 1800 and exhibit water insolubility. The addition of polyoxyethylene moieties to this hydrophobic portion may increase the water solubility of the molecule as a whole, and the liquid character of the product may be retained up to the point where the polyoxyethylene content may be about 50% of the total weight of the condensation product, which corresponds to condensation with up to about 40 moles of ethylene oxide. [0037] (4) The condensation of ethylene oxide with the product resulting from the reaction of propylene oxide and ethylenediamine. The hydrophobic moiety of these products include the reaction product of ethylenediamine and excess propylene oxide, the moiety having a molecular weight of from about 2500 to about 3000. This hydrophobic moiety may be condensed with propylene oxide to the extent that the condensation product contains from about 40% to about 80% by weight of polyoxyethylene and has a molecular weight of from about 5,000 to about 11,000. [0038] (5) Amido amine oxide compounds. Examples of amido amine oxides, which may be useful in an embodiment, include, but are not limited to, cocoamidopropyl amine oxide, isostearylamidopropyl amine oxide, isostearylamidopropyl morpholine oxide, lauramidopropyl amine oxide, minkamidopropyl amine oxide, oleoamidopropyl amine oxide, olivamidopropyl amine oxide, sesamidopropyl amine oxide, stearamidopropyl amine oxide, wheat germ amidopropyl amine oxide, or mixtures thereof. [0039] The nonionic surfactant may generally be present at a level of about 0.05% to about 50% by weight. The nonionic surfactant may be a 12-15 carbon alcohol, ethoxylated with an average of about 3-15 moles of ethylene oxide and may be about 1% of the cleaner. [0040] Cationic surfactants may be used in an embodiment. Cationic surfactants include, but are not limited to, quaternary ammonium salts of the general formula: [0041] wherein the R groups coupled to the nitrogen are long or short hydrocarbon chains, typically alkyl, hydroxyalkyl or ethoxylated alkyl groups, and X is a solubilizing anion. Examples include, but are not limited to, coconut trimethyl ammonium chloride or bromide, coconut methyl dihydroxyethyl ammonium chloride or bromide, decyl triethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride or bromide, C 12-15 dimethyl hydroxyethyl ammonium chloride or bromide, coconut dimethyl hydroxyethyl ammonium chloride or bromide, myristyl trimethyl ammonium methyl sulfate, lauryl dimethyl benzyl ammonium chloride or bromide, di-alkyl imidazolines, or mixtures thereof. The cationic surfactant may be present at a level of about 0.05% to about 50% by weight. [0042] Anionic surfactants may be used in an embodiment. Examples of anionic surfactants include, but are not limited to, alkyl benzene sulfonates, having an alkyl chain length of C 8 -C 15 , primary and secondary alkyl sulfates such as C 8 -C 15 primary alkyl sulfates, alkyl ether sulfates, olefin sulfonates; alkyl xylene sulfonates; dialkyl sulfosuccinates; fatty acid ester sulfonates, primary or secondary alcohol sulfates, wherein the linear or branched primary alcohol sulfates have 10 to 20 carbon atoms, or mixtures thereof. The anionic surfactants may be present at a level of about 0.05% to about 50% by weight. Additional surfactants may be found in U.S. Pat. No. 6,221,831 to Emery, et al. and U.S. Pat. No. 6,204,234 to Herbots, et al., both of which are incorporated herein by reference. [0043] The acids include, but are not limited to, organic acids such as acetic, citric, lactic, tartaric acid, glycolic acid, or mixtures thereof. Other acids include, but are not limited to, hydrochloric acid and sulfamic acid. In an embodiment, a carboxylic acid may be a hydroxy monocarboxylic acid having up to 4 carbon atoms. In an embodiment, the acid content in the cleaner may be from about 1% to about 50% by weight of the formulation. [0044] A synthetic layered silicate as described herein, may be added to the toilet bowl cleaner to enable the cleaner to cling to the sidewalls of the toilet bowl. Having the cleaner cling to the toilet bowl maximizes the time that the cleaner may be in contact with the lime scale and other deposits. If no thickener is used, the cleaner may run down the side of the toilet bowl too quickly, without effectively cleaning the surface. [0045] Other ingredients such as pH adjusters, stabilizing agents, preservatives, fragrances and/or dyes may be included in the liquid cleaning composition. Stabilizing agents may be included to achieve phase stability, pH balance and other desired characteristics. Commonly used stabilizing agents include, but are not limited to, monoethanolamine, diethanolamine, triethanolamine, or mixtures thereof. [0046] In an embodiment, the pH of the liquid cleaner may be in the range of about 1 to about 4. Agents for controlling the pH may be included. Examples include, but are not limited to, carbonates, bicarbonates, mono, di and triethanolamine, alkali metal hydroxides, or mixtures thereof. [0047] Water may provide the balance of the liquid cleaning composition. In an embodiment, about 50% to about 99% water, by weight of the formulation, may be added. Fragrance may be added in an amount of up to about 1%. Further information on toilet bowl cleaners may be found in U.S. Pat. No. 6,153,572 to Stamm, which is incorporated herein by reference. [0048] In an embodiment, a gel cleaner may be formulated with a synthetic layered silicate, as described herein, and with similar materials as in the toilet bowl cleaner. Other polymers and co-polymers may be added to increase the viscosity, such that the gel may remain stable when the gel is applied to a surface. U.S. Pat. No. 5,977,050 to Faris, which is incorporated herein by reference, provides additional information on gel cleaner formulations. [0049] An oven cleaner may be formulated with a synthetic layered silicate as described herein. In an embodiment, water, synthetic layered silicate, polymer, solvent, alkali metal hydroxide, and tetrapotassium pyrophosphate may be mixed to make an oven cleaner. In an embodiment, about 2% of the synthetic layered silicate may be dispersed in sufficient water to provide a final water content, in the oven cleaner composition, of about 30% to about 50%. Tetrapotassium pyrophosphate may be added at about 0.05% to about 0.15%, by weight of water, in the oven cleaner composition. Alkali metal hydroxide may be added at about 10% to about 25%, by weight of water, in the oven cleaner composition. Other components may be added, such as, but not limited to, surfactants, solvents, and/or fragrances. Further formulations and details may be found in U.S. Pat. No. 3,779,933 to Eisen and U.S. Pat. No. 5,919,312 to Wierenga et al., both of which are incorporated herein by reference. [0050] The synthetic layered silicate, as described herein, may be formulated into a toothpaste composition. In an embodiment, a toothpaste may be formulated to provide anti-caries and anti-plaque characteristics. Sorbitol, at about 25% to about 35%, by total weight of the formulation, may be added to water along with about 0.1% to about 0.5% synthetic layered silicate. The final amount of water in the formulation may be about 10% to about 50%, by weight of the formulation. Silica may be added to the formulation at about 10% to about 30% by weight of water, and the remainder of the formulation may include a fluoride compound for anti-caries activity, flavorings, anti-bacterial additives, and/or anti-plaque additives. The fluoride compounds include, but are not limited to, sodium fluoride, potassium fluoride, sodium monofluorophosphate, stannous fluoride, or mixtures thereof. Tetrasodium pyrophosphate may be added as an anti-plaque compound. Anti-bacterial toothpaste formulations include, but are not limited to, 2,4,4′-trichloro-2′-hydroxydiphenyl ether (Triclosan) or 2,2′-dihydroxy-5,5′-dibromo-diphenyl ether. Additional information on formulations may be found in U.S. Pat. No. 5,525,330 to Gaffar, et al., which is incorporated herein by reference. [0051] A drilling fluid may be formulated with a synthetic layered silicate as described herein. In an embodiment, an aqueous calcium chloride solution, a synthetic layered silicate, a weighting agent (e.g. barium sulfate), and/or other viscosifiers, fluid loss agents, and/or surfactants may be used in the drilling fluid. Additional synthetic layered silicate may be added to the formulation if the drilling fluid contacts a salt formation. If the drilling fluid's ionic content increases, the additional layered synthetic silicate may be helpful in maintaining viscosity of the drilling fluid. Additional formulations and uses for synthetic layered silicates may be found in U.S. Pat. No 6,025,303 to Keilhofer, et al. and U.S. Pat. No. 6,022,833 to Mueller, et al., both of which are incorporated herein by reference. [0052] A glass cleaner may be formulated with a synthetic layered silicate, as described herein, to produce a non-drip glass cleaner. In an embodiment, about 0.5% to about 1.5% synthetic layered silicate, by weight of the formulation, may be dispersed in water. About 2% to about 10% of an alcohol, by weight of the formulation, may be added to the synthetic layered silicate dispersion. Examples of an alcohol include, but are not limited to, methanol, ethanol, 1-propanol, isopropanol, butanol, or mixtures thereof. An oil emulsifier may be added at about 0.5% to about 10%, by weight of the formulation. Examples of oil emulsifiers include, but are not limited to, an ammonia solution, butoxyethanol, propylene glycol, ethylene glycol, ethylene glycol polymers, polyethylene, methoxypolyethylene glycols, or mixtures thereof. A surfactant may be added to the formulation at about 0.1% to about 1% by weight of the formulation. This formulation may provide a non-drip, streak-free composition for surface and glass cleaning. Other formulations may be found in U.S. Pat. No. 4,315,828 to Church and U.S. Pat. No. 5,798,324 to Svoboda, both of which are incorporated herein by reference. [0053] A synthetic layered silicate, as described herein, may be formulated into a paint composition. In an embodiment, about 3 pounds to about 10 pounds of water may be added to about 55 pounds to about 65 pounds of resin. Examples of resins include, but are not limited to, (meth)acrylic acid, 2-hydroxyethyl (meth)acrylate, (meth) acrylic acid amideimides having a hydroxyl group, such as 1,1-dimethyl-1-(2-hydroxypropyl)amine (meth)acrylimide, 1,1-dimethyl-1-(2′-phenyl-2′-hydroxyethyl)amine (meth)acrylimide, 1,1-dimethyl-1-(2′-hydroxy-2′-phenoxypropyl)amine (meth) acrylimide, or mixtures thereof. About 2 pounds to about 5 pounds of propylene glycol, about 20 pounds to about 30 pounds of titanium dioxide, about 0.1 pounds to about 0.5 pounds of synthetic layered silicate may be added to the resin water mixture. In an embodiment, defoamers, dispersants and/or wetting agents may be added. Additional paint formulations may be found in U.S. Pat. No. 5,905,109 to Shimizu, et al., which is incorporated herein by reference. [0054] A synthetic layered silicate, as described herein, may be formulated into a water-based printing ink composition. In an embodiment, a polymeric resin binder may be added to water, followed by the addition of a water-soluble resin binder to produce a water/binder mixture. A water-soluble rosin salt resin and an aqueous emulsion resin polymer may be added to the water/binder mixture. A rewetting agent, pigment, soybean oil, and the synthetic layered silicate may be added to the ink composition. Compositions for printing inks may be found in U.S. Pat. No. 6,200,372 to Krishnan, et al., which is incorporated herein by reference. [0055] The following examples serve to illustrate methods of producing a synthetic layered silicate. The examples should not be considered limiting. Examples 1 and 2 are for comparative purposes and Examples 3, 4 and 5 are according to an embodiment. [0056] The following tests were used in the examples to characterize the synthetic layered silicate material. [0057] Electrolyte Tolerance [0058] A 2.5% by weight dispersion of the synthetic layered silicate in demineralized water was prepared and left to stand for 24 hours. The dispersion was then diluted to 2% by weight synthetic layered silicate concentration with pre-determined aliquots of electrolyte and demineralized water. Viscosity measurements were taken after a total of 48 hours since first mixing. The effect of an electrolyte on the dispersion of the synthetic layered silicate may be related to the viscosity measurements. The viscosity measurements were conducted using a Brookfield DVII viscometer. The electrolyte tolerance of Examples 1-5 were determined using sodium sulfate as the electrolyte. [0059] Hydration Rate [0060] The rate of hydration of a 2% by weight dispersion of the synthetic layered silicate in demineralized water containing tetra-sodium pyrophosphate was assessed by measuring the time taken for the optical density of the dispersion to reduce to a specified value. The hydration rate may be defined as this time expressed in tenths of a minute. If the optical density had not reached the specified value after 20 minutes the hydration rate was expressed as the absorbance value at a wavelength of 550 nm using a 4 cm cell at that time. [0061] Clarity [0062] The optical density of a 2% by weight dispersion of the synthetic layered silicate in tetra-sodium pyrophosphate solution was measured at 550 nm using a 4 cm cell. The measurement was made 24 hours after the preparation of the dispersion; it was normally performed on the dispersion retained from the above Hydration Rate test. [0063] Table 1 provides the quantities of reactants used in the preparation of Examples 1-5. TABLE 1 Quantities of Reactants Used to Produce Synthetic Layered Silicate Materials Example 1 Example 2 Example 3 Example 4 Example 5 1st amount of H 2 O (g) 168 168 279 330 379 Li 2 CO 3 (g) 2.2 5.6 11.2 16.8 22.4 2nd amount of H 2 O (g) 301 269 269 269 269 MgSO 4 .7H 2 O (g) 209 187 187 187 187 3rd amount of H 2 O (g) 330 300 252 201 152 Na 2 CO 3 (g) 83 75 63 50 38 Sodium Silicate solution a (g) 525 a 525 525 525 525 [0064] [0064] TABLE 2 X-ray Fluorescence Analysis (% by weight oxide basis) Example Example Example Example Example 1 2 3 4 5 SiO 2 65.51 66.67 67.25 67.03 67.29 MgO 30.63 28.47 28.56 28.57 28.67 Na 2 O 2.77 3.21 2.86 2.62 2.34 SiO 2 /MgO 2.14 2.34 2.35 2.35 2.35 [0065] [0065] TABLE 3 Comparison of Lithium Carbonate Added as Reactant (in grams) and Lithium Content in Final Product as % by weight Li Example Example Example Example Example 1 2 3 4 5 Lithium 2.2 5.6 11.2 16.8 22.4 Carbonate Lithium 0.35 0.50 0.59 0.66 0.74 [0066] [0066] TABLE 4 Hydration Rate and Clarity of Product from Examples 2-5 Example 2 Example 3 Example 4 Example 5 Hydration rate  1.35 1  0.25 1 175 0.79 1 Clarity 37.1 27.3  20.4 9.3 [0067] [0067] TABLE 5 Visacosity (cP) at 10 meq Na/g of Synthetic Layered Silicate Example Example Example Example Example 1 2 3 4 5 Viscosity flocculated 211000 108050 571000 182500 (cP) EXAMPLE 1 [0068] Example 1 was prepared following the procedure in U.S. Pat. No. 4,049,780, Example 2, which is incorporated herein by reference. EXAMPLE 2 [0069] Example 2 was prepared using the following procedure and the quantities of reactants listed in Table 1. The Li 2 CO 3 , 5.6 g, was dispersed in 168 g of water with agitation for 1 hour at ambient temperature. Water (269 g) was added to the lithium carbonate solution, followed by addition of 187 g of MgSO 4 .7H 2 O. The magnesium sulfate was allowed to dissolve for a few minutes and then the solution was heated to 60° C. In a separate container, 75 g of Na 2 CO 3 was dissolved in 300 g of water. The sodium carbonate solution was then added to the solution mixture of the lithium carbonate and magnesium sulfate over a period of 30 minutes, maintaining a temperature of 60° C. The sodium silicate solution (525 g) was added to the mixture of the magnesium sulfate, sodium carbonate and lithium carbonate over a period of 50 minutes, maintaining the temperature at 60° C. The resulting aqueous slurry was then heated to 98° C., and maintained at this temperature for 2 hours, condensing the vapor and returning the condensate to the aqueous slurry. The slurry was heated at 202° C. for 6 hours. The resulting hydrous magnesium silicate was separated by filtration, washed and dried. Example 2 represents a procedure in which the quantity of lithium compound used was only the stoichiometric amount needed to produce an atomic ratio equivalent to 8 atoms of silicon to 6 atoms of magnesium to 1 atom of lithium in the starting recipe. EXAMPLE 3 [0070] Example 3 was prepared following the procedure in Example 2, except that the reactant quantities were changed EXAMPLE 4 [0071] Example 4 was prepared following the procedure in Example 2, except that the reactant quantities were changed. EXAMPLE 5 [0072] Example 5 was prepared following the procedure in Example 2, except that the reactant quantities were changed. [0073] Referring to FIG. 1 and corresponding Table 5, Examples 3, 4 and 5 have a much greater tolerance to the presence of an electrolyte when compared to Example 1. Example 2 has improved tolerance to the presence of electrolyte, but this product has other disadvantages to Examples 3, 4 and 5. Table 2 is the oxide analysis of Examples 1-5. Table 3 is a comparison of the amount of lithium carbonate in the reactants compared to the amount of lithium present in Example 1-5. Table 4 indicates the Hydration Rate and Clarity of the products from Examples 2-5. The Hydration rate and Clarity data for Examples 3-5 indicate superior performance compared to Example 2. [0074] Further modifications and alternative embodiments of various aspects of the invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the invention. It is to be understood that the forms of the invention shown and described herein are to be taken as the presently preferred embodiments. Elements and materials may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the invention may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of this description of the invention. Changes may be made in the elements described herein without departing from the spirit and scope of the invention as described in the following claims.

1a

This application is a continuation of application Ser. No. 08/163,751, filed Dec. 7, 1993, now U.S. Pat. No. 5,354,201. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to devices for retaining flanged dental appliances in position. More particularly, the present invention relates to dentures having flexibly mounted flange extensions which aids in their retention and stabilization. 2. Description of the Prior Art Presently, conventional dentures or the like, especially mandibular and distal extension partial dentures are predominantly designed to be placed over the gums, and generally rely on gravity, tooth clasps, and/or adhesives to retain and secure them in place. Various denture retaining devices are available in the prior art, but have up to now met with limited success. For instance, U.S. Pat. Nos. 1,924,265 and 1,947,026 to Wharton disclose three piece lower dentures wherein two side pieces extend lower than a middle piece. Upon placement in the mouth, the pieces are attached together through interlocking tongue and groove or other construction which allow movement in a vertical direction. Besides the relative difficulty in naneuvering the three pieces in the user's mouth, any sufficient force on the central piece of these dentures from incisor load may not be effectively transferred to the side pieces. This may lead to shear separation of the connections between the central piece and side pieces. U.S. Pat. No. 3,919,771 to Ostermann discloses a device for retaining a lower denture having an externally attached fixed element, a retaining tongue which slides within the fixed element, and a cover piece which covers the fixed element and a portion of the retaining tongue. To use this device, the fixed element is secured to a lower denture such that the retaining tongue slides downward. After placement in the mouth, the user must slide the tongue below the mylohyoid ridge, then place the cover piece to secure the retaining tongue in position. Besides the necessity for complex user manipulation, this device applies pressure to the cavity below the mylohyoid ridge on a relatively small surface area. Further, the protruding structure of this device may lead to irritation and abrasion, thereby reducing the comfort with which the attached denture may be worn. U.S. Pat. Nos. 4,376,629 to Ebeling and 4,923,795 to Franklin disclose flexible dentures which grip the gums of users. However, these dentures do not extend below the mylohyoid ridge or any other like bone ridges to provide support. None of the above inventions and patents, taken either singly or in combination, is seen to describe the instant invention as claimed. SUMMARY OF THE INVENTION The present invention is drawn to flanged dental appliances which have incorporated therein a device which aids in retaining and stabilizing the appliances. The device includes hinging sections, and thickened flange extensions attached to the hinging sections. These hinging sections are attached to an interior flange of dental appliances so as to be positioned to lie along bone ridges, such as the mylohyoid ridges. Mechanisms or materials for providing positional memory cooperate within these hinging sections, thereby allowing the flanges to be flexed medially during insertion or extraction of the appliance. Once in place, the flange extensions hingedly return to their original configuration, settling into a fossa proximate to the bone ridge. This spreads equal pressure onto the extended surface area of the fossa proximate to the bone ridge to stabilize the appliance incorporating the present device. The stabilized appliance of the present invention will also resist dislodgement under load by redistributing forces across a bone ridge or ridges. The present device is advantageously incorporated into dentures such that a smooth surface is presented to all underlying and contacting tissue. The present invention preferably uses semi-rigid polymeric materials to provide biasing, positional memory, and smooth surface contact in and around the hinging sections. Semi-rigid materials may also provide the required hinging mechanism through which the appliance may be installed and removed. Optionally incorporated hinging structures, such as a spring loaded hinge or living hinges such as a scored polypropylene sheet, may be employed in the present invention to bolster flexibility, and/or positional memory. Further, when more than one flange extension is used across symmetric bone ridges, any applied force can be more effectively distributed, and the stabilizing effect is increased. Accordingly, it is a principal object of the invention to provide a device which allows dental appliances, especially mandibular and lower distal partial dentures, to be stabilized and secured in place by resisting dislodgement. It is another object of the invention to provide improved dentures which advantageously incorporate the present device. It is yet another object of the invention to provide stable dentures having smooth conforming surfaces which are comfortable to wear. Still further, an object of the invention is to provide devices which allow the user to consume a wider variety of foods with confidence. These and other objects of the present invention will become readily apparent upon further review of the following description and drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a posterior view of lower dentures according to the present invention. FIG. 2 is a side cut-away view of the right jaw, showing the right mylohyoid ridge. FIG. 3 is a side cut-away view of the right jaw, showing the lower denture of FIG. 1 in position. FIG. 4 is a posterior perspective view of lower dentures according to a preferred embodiment of the present invention. FIG. 5 is a side cutout view of lower dentures incorporating an optional spring loaded hinge. FIG. 6 is a partial side perspective view of lower dentures according to one embodiment of the present invention. FIG. 7 is a partial side perspective view of lower dentures incorporating a spring loaded hinge. FIG. 8 is a partial side perspective view of lower dentures according to another embodiment of the present invention. FIG. 9 is a side partial sectional view of a hinging section incorporating an optional hinging mechanism according to the present invention. FIG. 10 is a side partial sectional view of a hinging section according to one embodiment of the present invention. FIG. 11 is a side partial sectional view of a hinging section according to another embodiment of the present invention. Similar reference characters denote corresponding features consistently throughout the attached drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is advantageously applied in lower dentures as shown in FIG. 1. The present denture as a whole is designated reference numeral 1, and includes an upper section 2 including ranged sections, hinging areas 3, and flange extensions 4. Upper section 2 incorporates analogous elements of conventional dentures. In FIG. 1, upper section 2 includes teeth such as incisors 6 and molars 7. The present invention may be used to secure and stabilize appliances across any underlying substantially straight section of an intraoral bone ridge, and is particularly advantageous when used across the mylohyoid ridge 5, as shown in FIG. 2. Preferably, two devices according to the present invention are advantageously positioned over both mylohyoid ridges 5, with the flange extensions 4 applying slight pressure to the tissue of the submandibular fossae under the mylohyoid ridge, as seen in FIG. 3. The interior of a ranged denture useful in the present invention, which contacts the tissue of the mouth, is shaped to conform to the individual user, being the complimentary shape of substantially all features of the user's intraoral tissue that the denture will overlay. This may be accomplished by making a cast of the user's mouth. The cast preparation may be accomplished with readily available materials and techniques with the stipulation that the tissue over which flange extensions 4 will be positioned must be included in the casting. Preferred materials for making the cast include gypsum, resin, silicone, and rubber. Preferred techniques for making the cast include forming a dental impression, using these materials to create a mold, which is then poured with a thermal setting modeling composition. The resultant model of the user's mouth is then prepared before creating the appropriate flanged appliance. Areas on the model that correspond to the tissue over which flange extensions 4 will be positioned is relieved or shaved. Preferably, from 0.2 to 1 mm is relieved from these areas. Most preferably, from 0.25 to 0.50 mm is relieved. For example, in appliances such as lower dentures where the bone ridges used are the mylohyoid ridges, the area relieved corresponds to the tissue overlying the submandibular fossae. The appropriate flanged appliance of the present invention is then manufactured on the model. Preferably, hard denture base is use to create the foundation of the appliance. Preferred materials for the denture base include hard acrylics, such as methyl methacrylate with a low water content, vinyl, and silicone. The hard denture base may be textured or detailed to simulate gums and like tissue where appropriate. In lower dentures 1, upper section 2 and flanges 4 are most preferably created unitarily from hard acrylic, and teeth 6 and 7 are inserted or rendered on upper section 2. The hinging section 3 may then be created. The considerations important in the creation of the hinging section include: 1) sufficient freedom of movement such that the attached flange extension may in one state be positioned to apply pressure against the tissue overlying a target fossa, and in a second state be unrestricted by any bone ridge; 2) positional memory for at least the above first state, such that once installed, the attached flange extensions will reposition to exert the necessary pressure in cooperation with the appliance as a whole, and will distribute forces across the height of contour over which the hinging section rests; and 3) the hinging section should remain smooth to the tissue, having no fissures or sharp protrusions to irritate and/or lacerate tissue. Disparate elements may be used to provide the necessary functionalities. A biasing mechanism can be used to urge the flange extension to pivot about the hinging area in a direction towards the fossae proximate to the bone ridge, having a stop when the flange extension reaches the first state, and flexible materials incorporated into the hinging ares to cover the biasing mechanism. Alternatively, the necessary functionalities may be met by the inherent resilience in the materials incorporated into the hinging areas or by a combination of both. As can be seen best in FIGS. 9-11, a portion of upper section 2 corresponding to the interior part of a flange which lies along the gums of the mouth, and the flange extension 4, in the first state meet at a line which is substantially over and parallel to the line demarcated by a substantially linear bone ridge. This configuration may be achieved by forming 2 and 4 unitarily, then cutting a groove or grooves through the unitary piece to form the separate parts. Alternatively, 2 and 4 may be formed separately, having angled edges. The angle defined by the cut sides of the groove, or the angled edges of 2 and 4, is preferably between 30 degrees and 100 degrees, being preferably about 35 degrees-50 degrees when a single groove is cut, as shown in FIG. 9 and about 35 degrees-90 degrees when two grooves are cut, as shown in FIG. 11. Preferred constructions of the hinged section utilize semi-rigid materials in a wedge or wedges 10 filled in between upper section 2 and flange extension 4. Further, to enhance the positional memory across the hinged section, an additional liner of semi-rigid material 9 may be applied to the inside surface around the hinged area to provide biasing. Liner 9 may run along the full height of the appliance, as shown in FIGS. 6 and 7, or be substantially located only in the hinged section. The denture base material of 2 and 4 may be relieved to accommodate liner 9, or the liner may be cast prior to 2 and 4 upon the model of the users mouth. The passive, semi-rigid materials used in wedge 10 and liner 9 include any intraorally acceptable polymeric material which preferably has sufficient elasticity that a user may flex the hinged section to the second state, yet have sufficient rigidity to maintain the first state under typical loads for the appliance. A device such as disclosed by Eckland, U.S. Pat. No. 5,055,041 may be used to determine the necessary characteristics of the material. Preferably, the material is an acrylic. Most preferably, the material is a methyl methacrylate, with higher water content than used in a hard denture base. The use of methyl methacrylate is desirable, since its rigidity and elasticity may be altered by the level of hydration in curing. When both the wedge material 10 and liner 9 is used in the hinged area, the wedge material is preferably less rigid than the liner material. As the denture base may also be made from methyl methacrylate with a low water content, the materials necessary for the instant invention are readily available in this most preferred embodiment. Optionally, further mechanisms 11 may be used to enhance the positional memory of the hinging section. These may be used in conjunction with liner 9, as shown in FIG. 9 or without a liner, as shown in FIG. 11. The mechanism 11 may be of the spring loaded biasing type having hinge 12, spring 13, and biasing members as shown in FIG. 5. This type of mechanism when utilized should be made from biocompatible materials, such as surgical steel, and have an axis of hinging action substantially along the line demarcated by the underlying bone ridge. Preferably, these mechanisms are embedded into the denture base material of 2 and 4 prior to hardening of the base material. Other mechanisms 11 may be used including living hinges, such as a rigid sheet of polypropylene or like crystalline plastic which is scored along the hinging axis. This type of mechanism may be embedded in the denture base material of 2 and 4, in substantially the same manner as the spring loaded biasing type. Holes may be provided on both sides of the score line such that the denture base material, as it cures, fixes the position of the mechanism. When mechanisms 11 are used to provide the positional memory and/or hinging action, the requirements on materials filling wedges 10 and liner 9 may be relaxed, as they no longer need to supply the transferred functionality. Accordingly, a wider range of materials may be used, the important consideration being the ability to provide a smooth surface for contacting tissue throughout the motion of the embedded mechanism. EXAMPLE 1 An alginate impression of a patient's mouth was made in the dentist chair which extended into the lingual sulcus. A custom tray was then fabricated in the lab, extending 3 mm from the sulcus in the lingual area. The custom tray was then fitted to the alveolar ridge, being trimmed and boarder molded as needed. While the impression making and fitting were performed, the patient was instructed to open his/her mouth to its fullest extent, and to place their tongue against the palate. Any displacement caused by this is corrected. The impression is then corrected with the modified custom tray. The resultant corrected impression was then poured in the lab to form a model of the patient's mouth in dental stone, and allowed to set. One to two millimeters was relieved from the area representing both the submandibular fossae in equal amounts. A mandibular denture was created on the model from methyl methacrylate denture base. 45° V shaped grooves were cut along both of the mylohyoid ridges, separating the denture into an upper section, and two flange extensions. Methyl methacrylate having a higher water content was filled into the grooves, and along the surface around the groove on the tissue contacting side of the denture. A mixture of 4:8 liquid to methyl methacrylate powder was used in the groove, and 4:10 liquid to powder was used along the contacting surface. CASE A A ninety-five year old woman upon losing her conventional lower denture was fitted with a mandibular denture according to Example 1. The patient had worn dentures for over fifty years, and the anterior portion of her mandibular alveolar ridge had resorbed to the point of almost being flat, leading to the instability and loss of her conventional dentures. Despite this, the improved stability of the dentures prepared according to the present invention allowed the patient to continue to wear lower dentures. CASE B A sixty year old man with an edentulous mandibular ridge had previously been unable to tolerate conventional lower dentures. After fitting the patient with mandibular dentures according to Example 1, the patient was able to immediately eat an apple without causing dislodgement of the dentures. It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments within the scope of the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 11/697,322 filed on Apr. 6, 2007, which is a continuation of U.S. patent application Ser. No. 10/897,371 filed on Jul. 22, 2004, now issued U.S. Pat. No. 7,318,839, which claims the benefit of U.S. Provisional Application No. 60/489,731 filed on Jul. 23, 2003. The disclosures of the above applications are incorporated herein by reference. INTRODUCTION [0002] The spinal column is a highly complex structure which houses and protects critical elements of the nervous system. In spite of these complexities, the spinal column is a highly flexible structure, capable of a high degree of curvature and twist through a wide range motion. Genetic or developmental irregularities, trauma, chronic stress, tumors, and disease, however, can result in spinal pathologies which either limit this range of motion, or threaten the critical elements of the nervous system housed within the spinal column. [0003] In various orthopedic surgical procedures, it is necessary to stabilize portions of a spinal column relative to one another. This need is typically a result of disease, damage or congenital deformation. In one method of treatment for intervertebral disk degeneration, the normal gap between adjacent vertebral bodies is surgically re-established and maintained with a rigid spacer inserted between the bodies. The rigid spacer is filled with bone graft material to facilitate bony fusion of the two vertebral bodies. A successful fusion stabilizes the spine, reduces pressure on the spinal cord and nerve roots, and reduces or eliminates back pain. [0004] While known devices for spinal fusion have proven to be effective in various applications, there remains a need for spinal implants that do not require large incisions for implantation, that can relieve localized stress on adjacent vertebral end plates, and that can prevent migration and retropulsion within the spinal column. SUMMARY [0005] The present teachings provide an expandable spinal implant including a first member and a second member. The first member has first and second arms. The first and second arms of the first member both including an upper face partially defining an upper contact area of the implant and a lower face partially defining a lower contact surface of the implant. The second member has first and second arms that both include an upper face partially defining an upper contact area of the implant and a lower face partially defining a lower contact surface of the implant. The first and second members are pivotally coupled to each other for relative movement about a rotation axis between a closed position for inserting the implant into a spine and an expanded position for providing structural support to the spine. The rotation axis extends generally perpendicular to the upper and lower contact surfaces. [0006] The present teachings also provide an expandable spinal implant having first and second members both with a central portion and first and second arms extending from the central portion. The central portion of the second member is coupled to the central portion of the first member for rotation about a rotation axis between a closed orientation for insertion into a spine and an expanded orientation for providing structural support to the spine. The spinal implant further includes a locking mechanism for arresting relative movement between the first member and the second member. [0007] The present teachings provide a method of stabilizing a portion of a spine. The method includes providing a spinal implant having a first elongated member and a second elongated member. The first elongated member has a central portion rotatably coupled to a central portion of the second elongated member for rotation between a closed position and an expanded position. The method additionally includes orienting the first and second elongated members in the closed position and inserting the spinal implant into the spine between first and second vertebral bodies. The rotation axis is vertically oriented. The method further includes rotating the first and second elongated members to the expanded position while the spinal implant is within the spine. [0008] The present teachings further provide an expandable spinal implant that includes a first member having first and second arms and a central portion between the first and second arms, and a second member completely separate from the first member, the second member having first and second arms and a central portion between the first and second arms. The central portion of the first member is rotatably coupled to the central portion of the second member about a rotation axis substantially perpendicular to the central portions between a closed position for inserting the implant into a spine and an expanded position for providing structural support to the spine, the first and second members coupled to each other such that the first and second arms of the first member alternate with the first and second arms of the second member. [0009] The present teachings provide an expandable spinal implant that includes a first member having a central portion and first and second arms extending from the central portion of the first member, a second member having a central portion and first and second arms extending from the central portion of the second member, the central portion of the second member coupled to the central portion of the first member for rotation about a rotation axis between a closed orientation for insertion into a spine and an expanded orientation for providing structural support to the spine, and a locking mechanism for arresting relative movement between the first member and the second member, the locking mechanism including a locking member manually operable to engage the first member with the second member in the expanded orientation. [0010] The present teachings further provide an expandable spinal implant that includes a first member having a central portion and first and second arms extending from the central portion of the first member, a second member having a central portion and first and second arms extending from the central portion of the second member, and a pivot member engaging respective first and second openings of the central portions of the first and second members for rotation between a closed orientation for insertion of the spinal implant into a spine and an expanded orientation for providing structural support to the spine. [0011] The present teachings further provide a method of stabilizing a portion of a spine. The method includes pivoting first and second members of an expandable spinal implant relative to one another to a closed configuration in which the spinal implant has a compact profile, inserting the spinal implant in the closed configuration into the spine between first and second vertebral bodies, and pivoting the first and second members crosswise to an expanded configuration while the spinal implant is within the spine. The first and second members are separate from and coupled to one another. [0012] In another aspect, the method includes pivoting first and second members of an expandable spinal implant relative to one another to a closed configuration in which the spinal implant has a compact profile and inserting the spinal implant in the closed configuration into the spine between first and second vertebral bodies. The first and second members are separate from and coupled to one another. The method further includes pivoting the first and second members to an expanded configuration while the spinal implant is within the spine, and arresting a relative movement between the first and second members by operation of a leaf spring formed by corresponding first and second central portions of the first and second members. [0013] In a further aspect, the method includes inserting an expandable spinal implant in a closed configuration between first and second vertebral bodies of a spine, and pivoting first and second members of the expandable implant to an expanded configuration while the spinal implant is within the spine. The first and second members are separate from and coupled to one another. The method further includes rotating a threaded fastener received in a bore of an arm of one of the first or second members, and locking the first and second elongated members in the expanded configuration with the threaded fastener. [0014] Further areas of applicability of the present teachings will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present teachings. BRIEF DESCRIPTION OF THE DRAWINGS [0015] The present teachings will become more fully understood from the detailed description and the accompanying drawings, wherein: [0016] FIG. 1 is a side view of an expandable spinal implant constructed in accordance with the present teachings, the expandable spinal implant shown operatively positioned between vertebral bodies of a human spine; [0017] FIG. 2 is a cross-sectional view taken along the line 2 - 2 of FIG. 1 , the expandable spinal implant shown in an expanded or open condition; [0018] FIG. 3 is a cross-sectional view similar to FIG. 2 , the expandable spinal implant shown in a contracted or closed condition to facilitate insertion into the spine; [0019] FIG. 4 is a perspective view of an expandable spinal implant according to the present teachings, and shown removed from the spine for purposes of illustration; [0020] FIG. 5A is a top perspective view of a first member of the expandable spinal implant of FIG. 4 ; [0021] FIG. 5B is a side view of the first member of the expandable spinal implant of FIG. 4 ; [0022] FIG. 5C is a bottom view of the first member of the expandable spinal implant of FIG. 4 ; [0023] FIG. 6 is a top view of the expandable spinal implant of FIG. 4 , shown in the closed position; [0024] FIG. 7 is a top view of the expandable spinal implant of FIG. 4 , shown in the open position; [0025] FIG. 8 is a perspective view of an expandable spinal implant according to the present teachings, shown in the open position; [0026] FIG. 9 is a top view of the expandable spinal implant of FIG. 8 , shown in the closed position; [0027] FIG. 10 is a top view of the expandable spinal implant of FIG. 8 , shown in the open position; [0028] FIG. 11A is a top view of a first member of the expandable spinal implant of FIG. 8 ; [0029] FIG. 11B is a side view of the first member of the expandable spinal implant of FIG. 8 ; [0030] FIG. 11C is an end view of the first member of the expandable spinal implant of FIG. 8 ; [0031] FIG. 12A is a top view of a second member of the expandable spinal implant of FIG. 8 ; [0032] FIG. 12B is a side view of the second member of the expandable spinal implant of FIG. 8 ; [0033] FIG. 12C is an end view of the second member of the expandable spinal implant of FIG. 8 ; [0034] FIG. 13A is a side view of a locking member of the expandable spinal implant of FIG. 8 ; [0035] FIG. 13B is an end view of the locking member of the expandable spinal implant of FIG. 8 ; [0036] FIG. 14A is a side view of a pivot member of the expandable spinal implant of FIG. 8 ; and [0037] FIG. 14B is an end view of the pivot member of the expandable spinal implant of FIG. 8 . DESCRIPTION [0038] The following description of various embodiments is merely exemplary in nature and is in no way intended to limit the present teachings, applications, or uses. [0039] With initial reference to FIG. 1 and FIG. 2 , an exemplary spinal implant constructed in accordance with the present teachings is illustrated and generally identified at reference number 10 . The spinal implant 10 is shown operatively associated with a human spinal column 12 . More specifically, the spinal implant 10 is shown positioned between a first vertebra 14 a and a second vertebra 14 b to stabilize the spine 12 . [0040] With continued reference to the environmental views of FIGS. 1 and 2 and additional reference to FIGS. 3 through 7 , the spinal implant 10 of the present teachings will be addressed in detail. The spinal implant 10 is illustrated to generally include a first member or first elongated member 16 and a second member or second elongated member 18 . As will become more apparent below, the first elongated member 16 and the second elongated member 18 are completely separate members and are coupled to one another for relative movement between a closed position or orientation (shown in FIG. 3 ) and an expanded position or orientation (shown in FIG. 2 ). As will be appreciated more fully below, the closed orientation facilitates insertion of the spinal implant 10 within the spine 12 through a small incision, while the expanded orientation disperses the load on the adjacent end plates. [0041] With particular reference to FIG. 4 , the implant 10 is shown removed from the spine 12 for purposes of illustration and articulated to the open position. As shown in FIG. 4 , the first elongated member 16 and the second elongated member 18 can be substantially identical to each other. For this reason, a description of the first elongated member 16 will serve to fully describe both the first elongated member 16 and the second elongated member 18 for the exemplary implant 10 . In view of this similarity, like reference numbers for implant 10 will be used throughout FIGS. 1-7 to identify common elements of the first elongated member 16 and the second elongated member 18 . It will be appreciated, however, that the first and second elongated members need not be identical, as is illustrated in FIGS. 8-14 for another exemplary implant 100 described below. [0042] Various different views of the first elongated member 16 are provided in FIGS. 5A through 5C in which the first elongated member 16 is separated from the second elongated member 18 . As seen in FIGS. 5A-5C , the first elongated member 16 is illustrated to include a central or intermediate portion 20 . The central portion 20 is generally circular and upwardly extends from a lower surface of the implant. The central portion 20 has a height equal to approximately one-half the height of the implant 10 . As a result, an upper or inner surface 22 of the central portion 20 is disposed at approximately a horizontal mid-line of the implant 10 . The central portion 20 also includes a lower or outer surface 24 . [0043] Extending through the central portion 20 , between the upper surface 22 and the lower surface 24 , is a through slot 26 . The through slot 26 permits bone ingrowth through the implant 10 to more rigidly secure the implant 10 within the spine 12 . The through slot 26 also reduces the weight of the implant 10 while maintaining the strength of the implant 10 . Further, the through slot 26 allows the implant 10 to be easily held and positioned by a physician using suitable medical instrumentation. [0044] Extending from opposite sides of the central portion 20 are a first arm 28 and a second arm 30 . In the embodiment illustrated, the first arm 28 and the second arm 30 are identical and generally extend tangentially from the central portion 20 . The first arm 28 and the second arm 30 preferably extend from the central portion 20 parallel to each other, but are slightly offset from each other. As seen best in FIG. 5B , the first arm 28 and the second arm 30 each include an upper wall 32 , a lower wall 34 , an outer wall 36 , and an inner wall 38 . The inner wall 38 extends from the lower surface 24 of the central portion 20 to a distance that is twice the distance between the upper surface 22 and the lower surface 24 to accommodate the central portion 20 of the second elongated member 18 , as described below. In this regard, a cavity is effectively defined to receive the central portion 20 of the second elongated portion 18 . [0045] As seen most clearly in FIG. 5B , within both the first arm 28 and the second arm 30 is a center opening or window 40 . The window 40 is defined by the upper wall 32 , the lower wall 34 , the outer wall 36 , and the inner wall 38 . The window 40 reduces the weight of the implant 10 and permits bone ingrowth through the first arm 28 and the second arm 30 to better secure the implant 10 within the spine 12 . [0046] The upper wall 32 includes an upper face 42 that partially defines an upper contact surface 44 . The lower wall 34 includes a lower face 46 that partially defines a lower contact surface 48 . The upper contact surface 44 and the lower contact surface 48 are preferably convex in shape. Alternatively, the upper and lower contact surfaces 44 and 48 may be flat or conically shaped. [0047] Both the upper contact surface 44 and the lower contact surface 48 are preferably formed to include a plurality of teeth 50 . The teeth 50 extend towards the central portion 20 . When the implant 10 is in its expanded orientation (as shown in FIG. 7 , for example), the teeth 50 of the various arms 28 and 30 of the implant 10 are concentrically arranged. Further, as seen most clearly in FIG. 5A , the teeth 50 are ramped in the direction of expansion of the implant 10 from the closed position to the open position to ease the expansion of the implant 10 and to ease the insertion of the implant 10 within the spine 12 . The ramped teeth 50 function to prevent the implant 10 from migrating and prevent retropulsion from the spine. [0048] With particular reference to FIG. 4 , FIG. 6 , and FIG. 7 , the coupling of the first elongated member 16 with the second elongated member 18 will now be described. The first elongated member 16 and the second elongated member 18 are coupled such that the inner surface 22 of the first member 16 and the inner surface 22 of the second member 18 are in contact with each other. Further, the first arm 28 and the second arm 30 of the first elongated member 16 are each positioned between the first arm 28 and the second arm 30 of the second elongated member 18 such that the arms 28 and 30 of the first elongated member 16 alternate with the arms 28 and 30 of the second elongated member 18 . [0049] The first member 16 and the second member 18 are pivotally coupled to each other for relative movement about a rotation axis R (identified in FIG. 4 ). The rotation axis R extends through the central portion 20 , generally perpendicular to the upper contact surface 44 and the lower contact surface 48 . This pivotal coupling permits relative rotation of the first member 16 and the second member 18 between the closed position and the open position. The first member 16 and the second member 18 are typically rotated between the closed position and the open position by a surgeon using appropriate operating room instrumentation. [0050] The elongated members 16 and 18 are illustrated coupled together in the closed position in FIG. 6 . In the closed position, the first arm 28 of the first elongated member 16 is positioned parallel to and adjacent to the second arm 30 of the second elongated member 18 . Further, the second arm 30 of the first member 16 is positioned parallel to and adjacent to the first arm 28 of the second elongated member 18 . Positioning the arms 28 and 30 of the first elongated member 16 parallel to and adjacent to the arms 28 and 30 of the second elongated member 18 provides the implant 10 with a slim and compact profile that permits the implant 10 to be easily inserted within the spine 12 requiring only a minimal disruption of the vertebrae 14 and the dura (not shown). [0051] With particular reference to FIG. 4 and FIG. 7 , the first elongated member 16 and the second elongated member 18 are shown coupled together in the open position. In the open position the first arm 28 of the first elongated member 16 is positioned apart from and in a non-parallel relationship to the second arm 30 of the second elongated member 18 . Likewise, the second arm 30 of the first member 16 is positioned apart from and in a non-parallel relationship to the first arm 28 of the second elongated member 18 . Generally, in the open position the first member 16 and the second member 18 are rotated such that the arms 28 and 30 of the first member 16 and the arms 28 and 30 of the second member 18 have an overall configuration approximating that of an “X”. This “X” shaped configuration provides the implant 10 with a great deal of strength to support the vertebrae 14 of the spine 12 . [0052] The first elongated member 16 and the second elongated member 18 each further comprise a pair of protrusions 52 and a pair cooperating of recesses 54 . The protrusions 52 extend from the upper face 42 and the recesses 54 are located within the outer surface 24 of the central portion 20 . The recesses 54 have a sidewall 56 and a retention surface 58 (see FIG. 5B ). As the first and second elongated members 16 and 18 are rotated from the closed position to the open position, the protrusions 52 rotate within the recesses 54 such that each protrusion 52 contacts both the sidewall 56 and the retention surface 58 . [0053] As seen most clearly in FIG. 5A and FIG. 7 , cooperation between the protrusions 52 of the first elongated member 16 and the recesses 54 of the second elongated member 18 , as well as cooperation between the protrusions 52 of the second elongated member 18 and the recesses 54 of the first elongated member 16 , ensures that the first elongated member 16 stays coupled to the second elongated member 18 when the implant 10 is in the open position. Specifically, interaction between the protrusions 52 and the retention surface 58 prevents the first member 16 and the second member 18 from becoming vertically separated along the rotational axis R of the implant 10 . [0054] To secure the implant 10 in the open position, the implant 10 further includes a locking mechanism. The locking mechanism is preferably an active locking mechanism comprised of an arm or detail 60 that extends from the central portion 20 of both the first member 16 and the second member 18 . The detail 60 is flexible, preferably a leaf spring, and can be moved between a neutral position (as shown in FIG. 5C ) and a collapsed position (as shown in FIG. 6 ). [0055] As seen in FIG. 6 , in the closed position the detail 60 of the second member 18 is resiliently collapsed against the inner wall 38 of the first member 16 (shown in FIG. 5B ). Likewise, in the closed position the detail 60 of the first member 16 is resiliently collapsed against the inner wall 38 of the second member 18 (not particularly shown). As the first member 16 and the second member 18 are rotated from the closed position to the open position, the details 60 resiliently return from beyond the respective inner walls 38 . [0056] In the open position the details 60 automatically extend into their neutral positions as the details 60 are no longer restricted by the inner walls 38 . In its neutral position, the detail 60 of the first elongated member 16 abuts an outer surface 62 of the inner wall 38 of the second elongated member 16 . Similarly, the detail 60 of the second elongated member 18 abuts an outer surface 62 of the inner wall 38 of the first elongated member 14 to prevent the implant 10 from returning to its closed position. The implant 10 can only be returned to the closed position if pressure is applied to the details 60 to return them to their collapsed state where they no longer contact the corresponding outer surfaces 62 respectively and can each again recede beneath the inner wall 38 of the opposite elongated member 14 or 16 . [0057] An exemplary implantation of the implant 10 of the present teachings within the spine 12 will now be described. Before the implant 10 is inserted, the spine 12 must be prepared to receive the implant 10 by the operating surgeon. Preparation of the spine 12 involves making a small incision posteriorly within the dura. The adjacent vertebrae 14 are distracted to return normal spacing and the intervertebral disk is removed. Once the spine 12 has been prepared, the implant 10 , orientated in the closed position, is inserted between the first vertebra 14 a and the second vertebra 14 b . To insert the implant 10 in the closed position requires only a small incision in the dura matter and only minimal distraction of the spine 12 , thus maintaining the integrity of the vertebrae 14 and permitting the surgeon to make the most efficient use of operating room time. When positioned in the open orientation ( FIG. 2 ), the spinal implant 10 stabilizes the spine 12 and facilitates the fusion of a pair of adjacent vertebrae 14 . [0058] After the implant 10 is properly installed within the spine 12 , the first member 16 and the second member 18 are rotated from the closed position to the open position so that the implant 10 may provide the required support between the adjacent vertebrae 14 . Rotation of the implant 10 from the closed position is effectuated by the attending surgeon using suitable operating room instrumentation. The implant 10 is maintained in the open position through interaction between the details 60 and the cooperating outer surfaces respectively. [0059] Rotation of the implant 10 into the open position is facilitated by the ramped teeth 50 , which are ramped in the direction of the expansion of the implant 10 from the closed position to the open position. The ramped teeth 50 also help maintain the implant 10 in the open position. Further, the ramped teeth 50 help maintain the implant 10 in its proper position between the vertebrae 14 . [0060] Adjacent vertebrae 14 may optionally be supported by multiple implants 10 . The process for inserting multiple implants 10 is substantially identical to the process described above for inserting a single implant 10 , with the exception being that at least one additional implant 10 is inserted between the vertebrae 14 during the insertion process. The use of multiple implants 10 is advantageous as multiple implants 10 provide additional support to the vertebrae 14 to further disperse stress loads. [0061] The implant 10 may be of various different sizes to properly fit patients having spines 12 and vertebrae 14 of different sizes. The size of the implant 10 may vary in numerous different ways. For example, the first elongated member 16 and the second elongated member 18 may be of various different lengths to support vertebrae 14 of different surface areas. Further, the first elongated member 16 , the second elongated member 18 , and the central portions 20 may be of different heights to support vertebrae 14 that are spaced at varying distances from each other. [0062] The implant 10 , may be manufactured from any biocompatible material that is suitably rigid to withstand the pressures exerted upon the implant 10 by the vertebrae 14 . Examples of materials that may be used to manufacture the implant 10 include, but are not limited to, titanium and allograft bone. As shown throughout the drawings, the first member 16 , and the second member 18 , each preferably comprise a single unitary structure. [0063] Referring to FIGS. 8-14 , another exemplary spinal implant 100 according to the present teachings is illustrated. Elements of implant 100 that correspond in some fashion to elements of implant 10 are designated with the same reference numbers, but prefaced by the numeral 1 . Detailed repetitious description of elements or features that can be identical in implants 10 and 100 is omitted. [0064] Referring to FIGS. 8-10 , the implant 100 includes first and second elongated members 116 , 118 pivotably connected to each other by a pivot member 210 for relative rotation therebetween about a pivot axis R, such that the implant 100 can be expanded from a closed orientation illustrated in FIG. 9 to an open (expanded) orientation illustrated in FIG. 10 . In the closed orientation, the first and second members 116 , 118 are substantially parallel, while in the open orientation the first and second members 116 , 118 are at an angle defining substantially an “X” shape. The first elongated member 116 has first and second arms 128 , 130 that interconnect with a central portion 120 . The second elongated member has first and second arms 128 ′, 130 ′ that interconnect with a central portion 120 ′. Recesses 172 , 172 ′ are defined respectively in the central portions 120 , 120 ′ of the first and second members 116 , 118 , such that the recesses 172 , 172 ′ are offset in the closed orientation, and aligned in open orientation. [0065] Referring to FIGS. 11A-C and 14 A-B, the first arm 128 of the first elongated member 116 , or, more generally, at least one of the arms, 128 , 130 , 128 ′, 130 ′, can be adapted to define an internally threaded bore 164 for accommodating a locking member 160 therein. The locking member 160 can be a fastener, such as an externally threaded screw, as illustrated in FIGS. 13A and 13B , and can be threadably engaged with the internal threads of the bore 164 . [0066] The locking member 160 can include an end portion or boss 170 and a head 172 with an engagement formation or surface 174 . The locking member 160 can be deployed to secure the implant 100 in the open orientation by engaging the first arm 128 of the first member 116 with the central portion 120 ′ of the second member 118 , when the implant 100 is in the open orientation. In the open orientation, the recesses 172 , 172 ′ in the central portions 120 , 120 ′ of the first and second members 116 , 118 become aligned and define a hole 168 that receives an end portion 170 of the locking member 160 . The locking member 160 can be deployed using a driver or similar tool that is inserted into the internal bore 164 of the first arm 128 and operated to engage the engagement formation 174 and to rotate the locking member 160 , thereby causing the locking member 160 to advance into the hole 128 and positively secure the implant 100 in the open orientation. [0067] Referring to FIGS. 14A and B, the pivot member 210 can be, for example, a fastener, such as screw or bolt, that engages openings 117 , 119 in the respective central portions 120 , 120 ′ of the first and second members 116 , 118 for relative rotation therebetween. The pivot member 210 can include a head 212 and a stepped shank 214 , which is received into the central openings 117 , 119 of the central portions 120 , 120 ′ of the first and second members 116 , 118 . The pivot member 210 can include a head formation 216 for receiving a tool for rotating the first and second members from the closed orientation to the open orientation after implantation. [0068] Referring to FIGS. 11B and 12B , all except the first arm 128 of the first member 116 can include openings or windows 140 to promote ingrowth. The second arms 130 , 130 ′ of the first and second members 116 , 118 can be identical. The first arm 128 ′ of the first member 116 can be wider in cross-section than the first arm 128 ′ of the second member 118 for accommodating the internal bore 164 that receives the locking member 160 , although the implant 100 in the closed orientation can have substantially constant total W, as shown in FIG. 9 . The threaded bore 164 of the first arm 128 can receive an instrument for inserting/deploying the implant 100 . The top and bottom surfaces of the arms 128 , 130 , 128 ′, 130 ′ can include a plurality of teeth 150 for engaging adjacent vertebrae as described above in connection with exemplary implant 10 . [0069] Similarly to implant 10 , implant 100 can be inserted in the spine 12 in the closed orientation through a small incision. After implantation, the first and second members 116 , 117 are pivoted about the central axis R relative to each other to bring the implant 100 to the open orientation. The implant 100 is then positively locked in the open orientation by deploying the locking member 160 using a suitable driver or tool. [0070] It will be appreciated that implants 10 and 100 are merely exemplary illustrations, such that various features of exemplary implant 10 can be incorporated in exemplary implant 100 , and vice versa. [0071] The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the present teachings are intended to be within the scope of the present teachings. Such variations are not to be regarded as a departure from the spirit and scope of the present teachings.

1a

DISCLOSURE OF PARENT APPLICATIONS This application is a continuation-in-part application of Ser. No. 08/164,576, filed Dec. 10, 1993, now U.S. Pat. No. 5,496,953; which is in turn a continuation-in-part of Ser. No. 07/792,648, filed Nov. 15, 1991, now abandoned; which is in turn a continuation-in-part of Ser. No. 07/564,755, filed Aug. 9, 1990, now U.S. Pat. No. 5,128,118 and also a continuation-in-part of PCT/US91/05553, filed Aug. 9, 1991, the national phase of which is U.S. Ser. No. 07/972,472, now U.S. Pat. No. 5,413,779; all of which are incorporated herein by reference in their entirety. FIELD OF THE INVENTION This invention is directed to a class of binding ligands for cocaine and other receptors in the brain. Specifically, a new method of making novel and unobvious compounds showing high binding specificity and activity, and, in a radiolabeled form, can be used to bind these receptors, is provided. The compounds produced by the method are useful in biochemical assays, imaging techniques, and in a wide variety of drug treatment methodologies. Both a new synthetic method, and a key intermediate, are provided. In U.S. application Ser. No. 07/564,755, there is disclosure of a family of compounds exhibiting particularly high specificity and affinity for cocaine receptors and other neurotransmitter receptors in the brain of the formula: Where the broken line represents an optional chemical bond and the substituents at 2 and 3 may be at any position; The iodo substituent may be at o, m, p, or multisubstituted; R 1 =CH 3 , CH 2 CH═CH 2 , (CH 2 ) n C 6 H 5 n=1-4; R 2 =CH 3 , C 2 H 5 , CH 3 (CH 2 ) 3 , (CH 3 ) 2 CH, C 6 H 5 , C 6 H 5 CH 2 , C 6 H 5 (CH 2 ) 2 ; X=pharmacologically acceptable anion ##STR1## Sites of specific interest included cocaine receptors associated with dopamine transporter sites. Subsequently, in the U.S. PCT Application from which priority is claimed, PCT/US91/05553, now U.S. Pat. No. 5,413,779 and which is incorporated herein by reference, the values for R 1 and R 2 were expanded, such that R 1 may be an alkyl of 1-7 carbon atoms, CH 2 CR 3 =CR 4 R 5 wherein R 3 -R 5 are each, independently C 1-6 alkyl, or phenyl compounds of the formula C 6 H 5 (CH 2 ) y , wherein y=1-6. The PCT filing also reveals the affinity of these compounds for cocaine receptors associated with serotonin transporters, and confirms, for the first time, that the in vitro binding reported in the earlier-filed application, is confirmed in in vivo testing. Specific disclosure for a variety of applications, including using the receptors in both PET and SPECT scanning, wherein either the iodine substituent, or one of the carbon groups is radioactive (I-123, 125 or 131 and C11) thus providing methods for scanning the presence of specific cocaine receptors appears. Such scanning processes may be used to determine physiological conditions, such as Parkinson's Disease, to examine in general the density and distribution of specific cocaine receptors in various parts of the brain and/or body, to determine the efficacy of neurological treatments aimed at halting or reversing the degeneration of specific nerves in the brain, and screening drugs, such as antidepressant drugs. The affinity of these compounds, as reported in the applications incorporated, is surprisingly high, and compared with prior art compounds, such as [ 3 H]WIN 35,428, the novel compounds of these applications exhibit extremely low IC 50 values for binding inhibition. The immediate parent application, now U.S. Pat. No. 5,496,953 incorporated herein by reference, discloses related compounds of a formula ##STR2## Wherein Y=CH 2 R 3 , CO 2 R 2 , CONRR 1 , or ##STR3## R 1 =hydrogen, C 1-5 alkyl, R 2 =hydrogen, C 1-6 alkyl, C 3-8 cycloalkyl, C 1-4 alkoxy, C 1-6 alkynyl, halogen or amine, R 3 =OH, hydrogen, C 1-6 alkyl, C 3-8 cycloalkyl, C 1-4 alkoxy, Cl, Br, I, CN, NH 2 , NHC 1-6 alkyl, NC 1-6 alkyl, OCOC 1-6 alkyl OCOC 1-3 alkylaryl, A=S, O or N X=H, C 1-6 alkyl, C 3-8 cycloalkyl, C 1-4 alkoxy, C 1-6 alkynyl, halogen, amino acylamido, and Z=H, I, Br, Cl, F, CN, CF 3 NO 2 , N 3 , OR 1 , CO 2 NH 2 , CO 2 R 1 , C 1-6 alkyl, NR 4 R 5 , NHCOF 5 , NHCO 2 R 6 , wherein R 4 -R 6 are each C 1-6 alkyl, R and R 1 are independently H, C 1-6 alkyl, C 1-6 alkene, C 1-6 alkyne, phenyl, phenyl substituted with 1-3 of C 1-6 alkyl, alkene, alkyl or alkoxy, C 1-6 alkoxy, phenoxy, amine, amine substituted with 1-2 of C 1-6 alkyl, alkene, alkyne, alkoxy or phenyl or phenoxy or R and R 1 may combine to form heterocyclic structure including pyrrolidinyl, piperidinyl and morpholino moieties, unsubstituted or substituted with 1-2 C 1-6 alkyl, alkene, alkyne or alkoxy groups. These compounds exhibit unusually high affinity for binding to receptors for the dopamine transporter site, as well as the serotonin transporter site, again based on inhibition of [ 3 H]WIN 35,428 binding. The most efficient method for preparation of the compounds of the family of binding ligands discussed above is through a tri-methylstannyl precursor, referred to as RTI-89. This intermediate or precursor is prepared from anhydroecgonine methyl ester in three steps. The intermediate is a focus of the grandparent application, U.S. application Ser. No. 07/792,648 now abandoned. As the anhydroecgonine methyl ester is the most closely related commercially available compound, it is an object of those of ordinary skill in the art to provide a more direct and facile synthesis of the binding ligands described herein than the three-step synthesis leading to RTI-89. Additionally, it would be desirable to be able to provide an intermediate for the preparation of RTI-55 and the related compounds described above in a state of higher purity than the intermediate RTI-89, or its tri-butyl analogue which is also known in the art. SUMMARY OF THE INVENTION The above-described objects, and other objects developed hereinbelow, are achieved through the synthesis of an intermediate designated RTI-W148-1, which compound has the structure: ##STR4## wherein n=0-4 R 1 is alkyl of 1-7 carbon atoms, alkene of 1-7 carbon atoms; phenyl, unsubstituted or substituted with an alkyl of 1-4 carbon atoms, Y is CHR 3 , CO 2 R 3 , CONR 4 R 5 or ##STR5## wherein R 2 =H, CH 3 , C 2 H 5 , CH 3 (CH 2 ) 3 , (CH 3 ) 2 CH, C 6 H 5 , C 6 H 5 CH 2 , C 6 H 5 (CH 2 ) 2 , C 3-8 cycloalkyl, C 1-4 alkoxy, C 1-6 alkynyl, halogen (preferably Cl, Br or I), or amine; R 3 =OH, hydrogen, C 1-6 alkyl, C 3-8 cycloalkyl, C 1-4 alkoxy, Cl, Br, I, CN, NH 2 , NHC 1-6 alkyl, NC 1-6 alkyl, OCOC 1-6 alkyl, OCOC 1-3 alkylaryl, wherein R 4 and R 5 are independently H, C 1-6 alkyl, C 1-6 alkene, C 1-6 alkyne, phenyl, phenyl or amine substituted with 1-3 of C 1-6 alkyl, alkene or alkoxy, or is C 1-6 alkoxy, phenoxy, amine, or R 4 and R 5 may combine to form heterocyclic moieties including pyrrolidinyl, piperidinyl and morpholino, unsubstituted or substituted with 1-2 C 1-6 alkyl, alkene, alkyne or alkoxy groups, wherein A=S, O or N. This intermediate may be quickly converted to the binding ligands of the above-described class by iodine exchange using ICl and silver tetrafluoroborate. Where imaging or assay purposes are intended, the iodine is radioactive, i.e., 123 I, 125 I or 131 I. Where, instead, pharmaceutical uses are intended, such as a substitute for methadone and similar drug treatments, or other pharmaceutical ends, non-radioactive ICl may be used. DETAILED DESCRIPTION OF THE INVENTION The arylsilane intermediate of this invention is prepared quickly and conveniently from conventional starting materials, in a high degree of purity. It is quickly converted to the binding ligands described in the parent application for tracing (SPECT or PET) if desired, by iodination using ICl. The invention is exemplified herein with the identities of substituents R 1 -R 5 , A and n, selected so as to give the prototypical and commercialized radioactive binding ligand RTI-55, which has the formula ##STR6## As those of skill in the art will recognize, the identities for R 1 -R 5 , Y and A may be readily substituted into the starting materials used to prepared RTI-W148-1, as the starting material, the methylester, is readily substituted on, see, e.g., Clarke, J. Med. Chem. 16, 1260 (1973). EXAMPLE 3β[4-Trimethylsilyl)phenyl]-2β-carboxylic Acid Methyl Ester (RTI-W148-1): p-Iodophenyltrimethylsilane was synthesized according to literature procedures. 1 The aryl halide (1.633 g, 6.02 mmol) was added gradually to Mg turnings (0.317 g, 13.04 mmol) and an I 2 crystal under N 2 . Once the vigorous reaction had subsided, the Grignard was refluxed for 0.5 hr. The reagent was cooled to room temperature and transferred into a round bottom flask under N 2 . The standard procedure for the synthesis of other 3β-(phenyl)tropane analogues was used as follows: 2 The reaction vessel was cooled to -40° C. and a solution of anhydroecgonine methyl ester (0.226 g, 1.24 mmol) in 15 mL anhydrous ether was added dropwise over 10 min. The reaction was cooled to -78° C. and a solution of trifluoroacetic acid (1 mL) in 10 mL EtO was added dropwise over 10 minutes. The reaction mixture was warmed to 0° C. and water (25 mL) was added. If necessary, the aqueous layer was acidified to pH 2 (with conc. HCl) and the layers were separated. The aqueous layer was basified to pH 11 with NH 4 OH and filtered through celite. The aqueous layer was extracted with Et 2 O (4×50 mL). The organic layers were combined and dried over MgSO 4 . The solvent was removed under reduced pressure to afford 0.40 g of a cloudy oil. Purification was accomplished using flash chromatography (9/1 Et 2 O/Et 3 N diluted with 50% hexanes). The fractions were pooled to give 0.202 g (49.3% yield) of the RTI-W148-1 as a white solid. A second fraction (0.023 g) contained a mixture of the α and β-isomers. Recrystallization of the β-isomer (0.182 g) from petroleum ether afforded 0.155 g of product, mp. 117-119° C. Synthesis of RTI-55 from RTI-148-1: To a solution of 58 mg of RTI-148-1 in 4 mL of methanol was added 124 mg of silver tetrafluoroborate. The mixture was cooled to 0° C., and 0.64 mL of a 1.0 M solution of ICl in methanol was added. The reaction was allowed to warm to 25° C. and kept at that temperature for 2 h. The reaction mixture was diluted with water, basified with NH 4 OH, and extracted with CH 2 Cl 2 . Evaporation of the solvent gave 70 mg of RTI-55. Flash chromatography gave 60 mg (90%) of RTI-55. Synthesis of 3β[4-Trimethylsilyl)Phenyl]-2β-Carboxylic Acid Methyl Ester (RTI-W148-1) ##STR7## This invention has been described in both generic terms, and by reference to a specific description. No specific description or example is considered binding, unless so identified. Alternate forms and conditions will occur to those of ordinary skill in the art, without the exercise of inventive faculty, and remain within the scope of this invention, save as limited by the claims set forth below.

1a

BACKGROUND OF THE INVENTION 1. Field of Invention This invention relates to fire protection systems and specifically to a novel inflatable bag apparatus for deploying gaseous and vaporizable fire extinguishing and explosion suppression agents. 2. Prior Art Several basic mechanisms for effecting fire extinguishing and explosion suppression for various combustible fuel/oxidizer combinations exist. These are: (a) separation of fuel from the oxidizer (typically air) e.g. mechanical fire fighting foam agents; (b) dilution of oxidizer to a concentration below which it cannot support combustion e.g. with an inert gas such as helium; (c) cooling of the reactants (fuel and oxidizer) and sufficient absorption of the thermal energy output to quench the combustion process e.g. by application of water spray; and (d) the chemical inhibition of the production of free radicals essential to the sustenance of the combustion process e.g. by a chemical agent such as bromotrifluoromethane (CF3Br). Agent selection, storage, quantity and dispensing method are affected by the particular fire protection problem or application which, in turn, dictates operational (environment; habitable vs. non- habitable, etc.) and system weight, volume and cost constraints, e.g. ground facilities versus aircraft applications. In general, fire extinguishing agents are applied in either (a) a local application mode such as from a portable hand held fire extinguisher or from a turret on a fire fighting vehicle, or (b) a total flooding mode such as by the rapid distribution of a fire extinguishing agent via fixed nozzles into a confined space so as to achieve a concentration level in air throughout the entire volume sufficient for fire extinguishment. Modern aircraft turbine engine installations are representative of a confined space fire protection application and are considered natural "fire zones" because of the inherent presence of an ignition source(s) and the close proximity of flammable/combustible fluids such as jet fuel, engine oil and, in many instances, hydraulic fluid. The "fire zone" designation requires that overheat/fire detection and in the case of most multiengine aircraft, fire extinguishing systems be provided for protection of crew, passengers and equipment. These protection systems are in addition to the rigorous application of fire prevention and hardening measures such as unidirectional, high velocity air flow to purge volatile combustible fluid leaks while also reducing the likelihood of hot surface ignition, and suitable fire walls to prevent fire penetration into adjacent compartments. Fire detection systems respond in the matter of a few seconds. Fire extinguishing systems once activated also respond very rapidly and are designed to discharge a halon chemical fire extinguishing agent such as bromotrifluoromethane (CF 3 Br) into the compartment so as to achieve a certain minimum volume percent concentration (6% for CF 3 Br; varies with the particular agent used) simultaneously at all locations in the engine compartment and hold that concentration for a short time (approximately 0.5 second) to achieve extinguishment. The fire extinguishing system typically entails a bottle to store the fire extinguishing agent under pressure, an open ended distribution conduit leading to an appropriate location within the "fire zone" and an electro-mechanical valve or electro-explosive (squib) rupture diaphragm incorporated into the neck of the bottle for triggering release of the agent. No provision is incorporated to terminate engine compartment ventilation air in the event of fire; consequently, determination of agent quantity requirements for a particular installation entails consideration of several factors but, in particular, engine compartment free volume and ventilating air flow (as a function of flight profile). Overall agent effectiveness is reduced (quantity increased) by agent leakage out and/or air leakage into the fire control area thereby decreasing agent dwell time and by agent/air mixing inefficiencies. No apparatus is known, however, which simultaneously overcomes these agent/air mixing inefficiencies. Military and civil aircraft currently employ halon agents such as bromotrifluoromethane (Halon 1301) and bromochlorodifluoromethane (Halon 1211) in on-board fire extinguishing systems for the protection of engine installations and other areas designated as "fire zones". These agents evolved from industry and principally Department of Defense (DOD) research and development efforts which were begun in the 1950's and provide outstanding fire extinguishing effectiveness and other favorable toxicologic, operational and system attributes which made them essentially the "universal" choice for these applications. Unfortunately, these same extinguishants, upon release into the atmosphere, have been tabbed in recent years to possess characteristics which make them extremely bad actors from the standpoint of depleting the "critical" ozone level in the earth's stratosphere and consequently has led to an international ban on their future production. Effective (cost and performance) alternative fire protection techniques are urgently needed for aircraft flight safety and survivability to fill the void resulting from the banning of these halon "chemical" extinguishants. There are several on-going efforts which are directed at the identification and evaluation of alternative and replacement materials for the Halon 1301 and 1211 agents for both aircraft and ground fire protection applications. Candidates under consideration include perfluorocarbons, hydrofluorocarbons, hydrochlorofluorocarbons, hydrobromofluorocarbons, iodofluorocarbons, dry chemicals, carbon dioxide, nitrogen and mixtures of basically inert gases. It is generally accepted that the development of "true" replacements for halons 1301 and 1211 for aircraft and ground applications is not imminent. SUMMARY OF THE INVENTION The principal objective of this invention is to provide an improved fire extinguishing apparatus or system which is capable of enhancing the effectiveness of various gaseous and vaporizable fire extinguishing agents for ventilated and confined space compartments/volumes fire scenarios by essentially reducing the availability of oxidizer (normally air) and increasing agent dwell (staying) time. This invention provides a means of overcoming the inherent short-fall in fire extinguishant effectiveness associated with current alternative agents while at the same time being amenable to the integration of chemical fire extinguishing agent advancements made by others, especially the vaporizing liquid and gaseous types of agents. Another object is to provide an apparatus which offers compact and lightweight storability while also offering design flexibility to accommodate varying volume and configuration fire protection applications. A further objective is to provide an apparatus which is amenable to various materials of construction and deployment configurations to meet the varying environmental, operational and/or space demands of a specific end application. The foregoing objects can be accomplished by providing an inflatable bag as the final element in the system for fire extinguishing agent distribution. Other objects and many of the associated advantages will readily be appreciated as the subject invention becomes better understood by reference to the following detailed description, when considered in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a sectional view of a compartment fire extinguishing apparatus embodying the present invention; FIG. 2 is a view of the apparatus installed in a typical compartment in the deployed stage; FIG. 3 is an enlarged view of the inflatable bag storage/dispensing container; FIG. 4 is a view of an orifice in the inflatable bag for agent release; FIG. 5 is a view of inflatable bag rupture for agent release; FIG. 6 is a view of a compartmented inflatable bag; FIG. 7 is a view of a check valve in the inflatable bag for agent release; FIG. 8 is a view of an inflatable bag incorporating non-permeable material for blockage of normal ventilating air and permeable material for agent release; and FIG. 9 is a view of an inflatable bag constructed from a permeable material with a non-permeable coating applied on the air blocking surfaces. DETAILED DESCRIPTION In the exemplary form of the invention illustrated in FIG. 1, a novel inflatable bag fire extinguishment apparatus is shown generally at 1 in association with a compartment wall 2 confining a fire zone 3. The apparatus 1 comprises a reservoir (bottle or flask) 4 containing a charge of gaseous vaporizable liquid fire extinguishing agent 5 under pressure. The bottle 4 is equipped with discharge means (an electrically operated release valve or squib actuated rupture diaphragm) 6 and an agent distribution conduit duct 7 connected to an inflatable bag 8 within a storage/release container 9. Upon discharge actuation the bag is rapidly expanded into the compartment (fire zone 3) or air inlet into the fire zone 3 upon discharge actuation 6 resulting in release of the fire extinguishing agent 5 from the bottle 4. Also shown is the inclusion of an air ejector/aspirator 10 in the agent distribution conduit 7 for premixing extinguishing agent 5 with external air at concentrations suitable for fire extinguishment. The bag 8 is shown in a deployed state in FIG. 2 in a ventilated 11, 12 compartment 2 designated as a fire zone 3. The expanded bag 8 blocks the air flow path 11 and releases fire extinguishing agent thru perforations or pores 13 in the bag material 8 into fire zone 3 to extinguish the fire 14. FIG. 3 provides an enlarged view of a typical bag storage/dispensing container 9, the stowed collapsed inflatable bag 8 and a fire resistant flapper door or protective cover 15 through which the inflatable bag enters the fire zone 3. Upon detection of a fire in the compartment the system is actuated by control 6 resulting in release of fire extinguishing agent 5 through the distribution conduit 7 into the stowed inflatable bag 8 causing it to emerge thru the flapper door or protective cover 15 and fully inflate into compartment 2 and thereby block incoming ventilating air 11 which is needed to sustain the fire, displacing a portion of the residual air 12 in the compartment and simultaneously dispersing extinguishing agent into the remaining voids within the compartment thru perforations 13 in a portion of the surface of the inflatable bag 8 thereby extinguishing and controlling the fire in the compartment 2. The system accomplishes fire control by employing several of the basic mechanisms described earlier in the Prior Art section of this patent, viz. separation of the oxidizer (air) from the fuel, chemical inhibition of the flame process and cooling of combustion reactants. More importantly, the overall efficiency and effectiveness of the extinguishment process is greatly enhanced by significantly minimizing the agent dilution effects of the ventilating air 11, reducing discharged agent mixing limitations, and increasing agent dwell time within the fire zone area 3. FIGS. 4 through 9 contain many of the same components as FIG. 2 for reference and illustrate additional design options. FIG. 4 shows the fire extinguishing agent 5 exiting the bag 8 through a typical orifice 16 (example a button hole) in the bag 8. A bag may contain many orifices 16 on the fire side 14 of the bag 8. FIG. 5 shows a bag 8 which ruptures in a controlled way and discharges fire extinguishing agent 5 into the fire area 14. The bag 8 of FIG. 6 is divided by a non-permeable material 18 which contains a pressure release orifice or check valve 19 and includes a non-permeable material 22 on the upstream side and a permeable material 21 on the downstream side. The agent distribution conduit 7 supplies both compartments of the bag 8. Agent 5 flows from the upstream compartment of the bag 8 through check valve 19 into the downstream compartment of the bag 8 and then exits the bag 8 into the fire area 14. Check valve 19 together with check valve 20 maintains a portion of bag 8 inflated to block air flow even after agent depletion. In FIG. 7 the agent distribution conduit 7 supplies the bag 8. Agent 5 flows from the bag 8 through check valve 19 into the fire area 14. Check valve 19 together with check valve 20 maintains the bag 8 inflated to block air flow even after agent depletion. FIG. 8 shows a bag 8 with the upstream side 22 of the bag 8 constructed of a non-permeable material to prevent agent flow upstream. The downstream side 21 of the bag 8 is constructed of a permeable material to allow agent flow 17 into the fire area 14. The bag 8 of FIG. 9 is constructed of a permeable material 21 with the upstream side of the bag 8 containing a coating of a non-permeable material 23 to prevent agent flow upstream. Additionally, a variety of hybrid bag configurations are possible wherein the bag design can include various combinations of the above features, FIGS. 4 through 9, to accomplish fire extinguishment action. Lightweight, stowable and strong inflatable bags can be made of a variety of available thermoplastic (i.e. fluoroplastics and polyimides) and elastomeric (i.e. fire resistant neoprene) materials or fabricated from various high temperature, fire resistant fiber materials such as PBI (polybenzimidazole). Fabric materials are available aluminized or with other types of laminates or films to provide a wide range of flame radiation and high temperature resistance properties in conjunction with suitable gas permeability and strength characteristics which make them acceptable for the already well defined fire environment exposure conditions associated with typical organic fuel/air fires. For example, the aircraft engine compartment fire scenario thermal radiation exposure levels expected for the deployed bag would be 12 watts per cm 2 for a few seconds. Bags can be configured to various shapes and volumes as dictated by the specific nature of the particular fire protection application. Available materials also offer a broad range of physical and chemical properties capable of fulfilling both the long term environmental storage and the short term fire exposure requirements dictated by a variety of foreseen fire protection applications. Depending on the specific fire protection application, one or more inflatable bags, possibly of different size and configuration, can be employed for effecting air blocking and agent distribution or for just air blockage. While the above description contains many specificities, these should not be construed as limitations on the scope of the invention, but rather as an exemplification of one preferred embodiment thereof. The compartment 2 is only one example of a location in which the system of the invention may be used to great advantage. Various alternatives to the pressurized stored gaseous or vaporizing liquid fire extinguishing agent source described in the main illustrated embodiment of our invention are also possible. These alternative sources for gaseous or vaporizable chemical and/or physical inerting agents for example include solid gas generators for the direct production of nitrogen inerting gas and hollow fiber permeable membrane or molecular sieve based generators which produce nitrogen inerting gas by separating it out of the air. Accordingly, the scope of the invention should be determined not by the embodiment illustrated, but by the appended claims and their legal equivalents.

1a

INTRODUCTION [0001] The present invention relates generally to the fields of genetics and medicine. The present invention more particularly discloses the identification of a human hypercholesterolemia causal gene, which can be used for the diagnosis, prevention and treatment of hypercholesterolemia, and more particularly familial hypercholesterolemia ADH, as well as for the screening of therapeutically active drugs. The invention more specifically discloses that mutations in the PCSK9 gene encoding NARC-1 cause autosomal dominant hypercholesterolemia (ADH) and represent novel targets for therapeutic intervention. The invention can be used in the diagnosis of predisposition to, detection, prevention and/or treatment of cholesterol and lipoprotein metabolism disorders, including familial hypercholesterolemia, atherogenic dyslipidemia, atherosclerosis, and more generally cardiovascular diseases (CVD). BACKGROUND [0002] Atherosclerosis is a disease of the arteries responsible for coronary heart disease (CVD) that underlies most deaths in industrialized countries (Lusis, 2000). Several risk factors for CHD have now been well established: dyslipidemias, hypertension, diabetes, smoking, poor diet, inactivity and stress. The most clinically relevant and common dyslipidemias are characterized by an increase in beta-lipoproteins (VLDL and LDL particles) with hypercholesterolemia in the absence or presence of hypertriglyceridemia (Fredrickson et al, 1967). An isolated elevation of LDL cholesterol is one of the most common risk factors for CVD. Twin studies (Austin et al, 1987) and family data (Perusse, 1989; Rice et al, 1991) have shown the importance of genetic factors in the development of the disease, particularly when its complications occur early in life. Mendelian forms of hypercholesterolemia have been identified: at first the autosomal dominant form (ADH) (Khachadurian, 1964) and later the autosomal recessive form (ARH), initially described as “pseudohomozygous type II hyperlipoproteinemia” (Morganroth et al, 1967). [0003] ADH is an heterogeneous genetic disorder. Its most frequent and archetypal form is Familial Hypercholesterolemia (FH) with a frequency of 1 in 500 for heterozygotes and 1 per million for homozygotes (Goldstein et al, 1973). The disease is co-dominant with homozygotes being affected earlier and more severely than heterozygotes. FH is caused by mutations in the gene that encodes the LDL receptor (Goldstein & Brown, 1978) (LDLR at 19p13.1-p13.3) (MIN 143890). It is characterized by a selective increase of LDL cholesterol levels in plasma giving rise to tendon and skin xanthomas, arcus corneae and cardiovascular deposits leading to progressive and premature atherosclerosis, CHD and mortality (occurring before 55 years). The second form of ADH is Familial Defective apo B-100 (FDB) caused by mutations in the apolipoprotein B gene (APOB at 2p23-p24), encoding the ligand of the LDL receptor (Inneraty et al, 1987) (MIN 144010). The existence of a greater level of genetic heterogeneity in ADH (Saint-Jore et al, 2000) has been reported and the implication of a third locus named HCHOLA3 (formerly FH3) has been detected and mapped at 1p34.1-p32 in a French family (Varret et al, 1999) (MIM 603776). These results were confirmed by Hunt et al. in a large Utah kindred (Hunt et al, 2000). [0004] There is a strong need of identifying genes involved in hypercholesterolemia, more particularly in ADH, in order to understand the mechanisms leading to these disorders and to develop improved diagnosis and therapeutic treatment. SUMMARY OF THE INVENTION [0005] The inventors have shown that mutations in the PCSK9 gene encoding NARC-1 cause autosomal dominant hypercholesterolemia. They have demonstrated that the NARC-1 protein contributes to cholesterol homeostasis. The invention thus discloses novel targets for diagnosis and therapeutic intervention for hypercholesterolemia, more particularly ADH, CVD, lipid and lipoprotein metabolism disorders, atherogenic dyslipidemia, atherosclerosis, and cardiovascular diseases. [0006] In a first aspect, the invention concerns a PCSK9 gene or a fragment thereof comprising an alteration, said alteration reducing, modifying or abolishing the activity of NARC-1. Preferably, said alteration is a nucleotide substitution. More preferably, said nucleotide substitution leads to an amino acid change in NARC-1 protein. Preferably, said amino acid change is located at or near the catalytic site or a zymogen processing of the NARC-1 protein and decreases the catalytic activity or autocatalytic cleavage of said protein or functional domain, respectively. Alternatively, the alteration affects the splicing of NARC-1 mRNA. [0007] The invention also concerns a corresponding NARC-1 protein or a fragment thereof comprising an alteration, said alteration reducing, modifying or abolishing the activity of NARC-1. Preferably, the alteration is located at the catalytic site of the NARC-1 protein and decreases its catalytic activity or at a zymogen processing site of NARC-1 and decreases its autocatalytic cleavage. In an other preferred embodiment, the alteration is located near the catalytic site of the NARC-1 protein and decreases its catalytic activity or near the zymogen processing sites of NARC-1 and decreases its autocatalytic cleavage. An aspect of the present invention concerns a method of genotyping in a subject a polymorphism of the PCSK9 gene, preferably a polymorphism disclosed in Table 2. The invention also concerns a method of associating one or several polymorphism(s) of the PCSK9 gene, preferably one or several polymorphism(s) disclosed in Table 2 to a disease or a disorder. [0008] An other aspect of this invention relates to a method of detecting the presence of or predisposition to hypercholesterolemia, more particularly ADH, or lipid and lipoprotein metabolism disorders in a subject, the method comprising detecting in a sample from the subject the presence of an alteration in the PCSK9 gene or in the NARC-1 protein, the presence of said alteration being indicative of the presence or predisposition to hypercholesterolemia, more particularly ADH, or lipid and lipoprotein metabolism disorders. In a most preferred embodiment, said alteration reduces, modifies, or abolishes the activity of NARC-1. Optionally, the method further comprises detecting the presence of an alteration in the LDL receptor and/or the apolipoprotein B in said sample. [0009] The invention also relates to a diagnostic kit comprising primers, probes and/or antibodies for detecting in a sample from a subject the presence of an alteration in the PCSK9 gene or in the NARC-1 protein, in the NARC-1 RNA or polypeptide expression, and/or in NARC-1 activity. Optionally, said diagnostic kit further comprises reagents for detecting in a sample from a subject the presence of an alteration in the LDL receptor and/or the apolipoprotein B. [0010] A further aspect of the invention relates to the use of a functional NARC-1, preferably a wild-type NARC-1 protein or a nucleic acid encoding the same, in the manufacture of a pharmaceutical composition for treating or preventing hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject. The invention also relates to the use of a biologically active compound which modulates NARC-1 activity, in the manufacture of a pharmaceutical composition for treating or preventing hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject. The invention also relates to a method for treating or preventing hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject comprising administering to said subject a functional NARC-1, preferably a wild-type NARC-1 protein or a nucleic acid encoding the same. The invention further relates to a method for treating or preventing hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject comprising administering to said subject a biologically active compound which modulates NARC-1 activity. [0011] An additional aspect of this invention relates to methods of selecting biologically active compounds that modulate the activity of NARC-1 protein, typically of an altered NARC-1 polypeptide. The compounds are more particularly suitable for treating hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. LEGEND TO FIGURES [0012] [0012]FIG. 1: Family HC92 Pedigree and Genetic Analysis with Markers Spanning the 1p34.1-p32 Region [0013] Affected subjects present with a history of tendon xanthomas (HC92-II-7 and III-3), CHD, early myocardial infarction (HC92-II-2 and II-6) and stroke (HC92-II-4). The affected allele is represented by the filled bars. Age (in years) at lipid measurement, total and LDL cholesterol (in g/L; untreated values for affected members) are given. [0014] [0014]FIG. 2: Genetic Analysis of Family HC2 [0015] Pedigree of the HC2 family is shown. Half-blackened symbols indicate affected members, unblackened symbols indicate unaffected members, and hatched symbols indicate members with an unknown phenotypic status. The haplotype in brackets of subject HC2-I-1 was unequivocally deduced. Selected markers spanning the 1p34.1-p32 region are displayed to the left of the pedigrees. The affected allele is represented by the filled bars. Age (in years) at lipid measurement, total and LDL cholesterol (in g/L; untreated values for affected members) are given. [0016] [0016]FIG. 3: Genetic Analysis and Mutation Detection in Families HC92 and HC60 [0017] a, Results of LINKMAP analyses in the HC92 family indicating a maximum lod score for D1S2742 at θ=0. PCSK9 maps 1.2 Mb to this marker. b, Mutation in family HC92. The proband (HC92-II-7) is heterozygous for a T→A substitution in exon 2 at nucleotide 625 (S127R). c, Family pedigree and genetic analysis of family HC60. d, Sequence analysis in family HC60. The proband (HC60-II-2) is heterozygous for a T→C substitution in exon 4 at nucleotide 890 predicting a substitution at 216 of leucine for the conserved phenylalanine (F216L). [0018] [0018]FIG. 4: Mutations Study [0019] a, Segregation of the S127R mutation in part of family HC2. The T→A substitution at nucleotide 625 creates a new recognition cleavage site for restriction digestion by MnlI (represented by *). After electrophoretic migration on a 2% agarose gel, fragments of 208, 203 and 60 bp were distinguished in the normal allele, while fragments of 208, 143 and 60 bp appeared in the mutated alleles (the 203 bp normal fragment was divided in fragments of 143 and 60 bp and the two 60 bp fragments generated comigrated). The proband (HC2-II-9) and one of her children (HC2-II-10) were observed to be heterozygous for the S127R mutation (as indicated by both the 203 and 143 bp bands). [0020] b, The amino acid sequence alignment for NARC-1 shows conservation of the serine at codon 127 between human, mouse and rat. DNA sequences of the normal and mutant genes are shown above and below the amino acid sequences, respectively. [0021] c, The amino acid sequence alignment for NARC-1 shows conservation of the phenylalanine at codon 216 between human, mouse and rat. DNA sequences of the normal and mutant genes are shown above and below the amino acid sequences, respectively. DETAILED DESCRIPTION OF THE INVENTION [0022] Definition [0023] The PCSK9 gene (or NARC-1 gene) encodes the NARC-1 protein or polypeptide. The NARC-1 protein is translated as a pre-protein which is autocatalytically processed into a mature NARC-1 protein. The sequence of the NARC-1 gene has been described in patent applications WO 01/57081 and WO 02/14358, and partly characterized in Seidah et al (2003). The residues of the NARC-1 catalytic site consist in Asp-186, Ser-188, His-226, Asn-317 and Ser-386. NARC-1 presents two zymogen processing sites : a first one comprising residues 78 to 82 and having a primary cleavage site located at position 82; a second one comprising residues 138 to 142 and having a putative secondary cleavage site located at position 142 . The biological function of NARC-1 and the implication of this protein in hypercholesterolemia and lipid and lipoprotein metabolism disorders were unknown. [0024] Within the context of this invention, the PCSK9 gene locus designates all PCSK9 sequences or products in a cell or organism, including PCSK9 coding sequences, PCSK9 non-coding sequences (e.g., introns, 5′ and 3′ UTR), PCSK9 regulatory sequences controlling transcription and/or translation (e.g., promoter, enhancer, terminator, etc.), as well as all corresponding expression products, such as PCSK9 RNAs (e.g. mRNA) and NARC-1 polypeptides (e.g., a pre-protein and a mature protein). [0025] The term “gene” shall be construed to include any type of coding nucleic acid, including genomic DNA, complementary DNA (cDNA), synthetic or semi-synthetic DNA, as well as any form of corresponding RNA. The term gene particularly includes recombinant nucleic acids encoding NARC-1, i.e., any non naturally occurring nucleic acid molecule created artificially, e.g., by assembling, cutting, ligating or amplifying sequences. A PCSK9 gene is typically double-stranded, although other forms may be contemplated, such as single-stranded. PCSK9 genes may be obtained from various sources and according to various techniques known in the art, such as by screening DNA libraries or by amplification from various natural sources. Recombinant nucleic acids may be prepared by conventional techniques, including chemical synthesis, genetic engineering, enzymatic techniques, or a combination thereof A particular example of a PCSK9 gene comprises SEQ ID NO: 1. [0026] The indicated positions in a PCSK9 gene and a NARC-1 protein refer to the positions in the sequences of SEQ ID No 1 and SEQ ID No 2, respectively. [0027] The term “hybridize under stringent conditions” means that two nucleic acid fragments are capable of hybridization to one another under standard hybridization conditions described in Sambrook et al., Molecular Cloning: A Laboratory Manual (1989) Cold Spring Harbor Laboratory Press, New York, USA. More specifically, “stringent conditions” as used herein refer to hybridization at 65° C. in a hybridization buffer consisting of 250 mmol/l sodium phosphate buffer pH 7.2, 7% (w/v) SDS, 1% (w/v) BSA, 1 mmol/l EDTA and 0.1 mg/ml single-stranded salmon sperm DNA. [0028] GENE & PROTEIN [0029] The invention concerns an isolated or recombinant PCSK9 gene comprising an alteration causing hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. [0030] The altered PCSK9 gene comprises an alteration leading to a decrease or a complete loss of NARC-1 activity, or to a new NARC-1 activity. This decrease, loss, or new activity can be due to the decrease or loss of the activity of NARC-1 enzyme, to the decrease of NARC-1 stability (either at the stage of nucleic acid or proprotein or protein), to a change of substrate specificity of NARC-1 or to the disturbance or impediment of the NARC-1 polymerization. This decrease or loss of NARC-1 activity can be due to a NARC-1 alteration leading to a decrease or loss of the pro-NARC-1 maturation, either at the first cleavage or the second one or both. The alteration can also affect the catalytic activity by modifying the catalytic site of NARC-1 or its substrate recognition site. Furthermore, the alteration can affect the splicing of the NARC-1 MRNA, leading to an alternative splicing product. [0031] The invention concerns an isolated or recombinant PCSK9 gene or fragment thereof comprising an alteration, wherein said alteration reduces, modifies or abolishes the activity of NARC-1. Preferably, said alteration is a nucleotide substitution. More preferably, said nucleotide substitution leads to an amino acid change in NARC-1 protein. Preferably, said amino acid change is located at (e.g., within) the catalytic site of the NARC-1 protein and decreases its catalytic activity, or is located at a zymogen processing site of NARC-1 and decreases its autocatalytic cleavage. In an other preferred embodiment, said amino acid change is located near the catalytic site of the NARC-1 protein and decreases its catalytic activity or near the zymogen processing sites of NARC-1 and decreases its autocatalytic cleavage. Alternatively, the alteration may affect the splicing of NARC-1 mRNA. More specifically, said alteration can be is a substitution at nucleotide 625 and/or 890 of SEQ ID No 1. More preferably, said alteration is selected from the group consisting of a T→A substitution at nucleotide 625 of SEQ ID No 1, a T→C substitution at nucleotide 890 of SEQ ID No 1 and a combination thereof. In a further embodiment, said alteration is selected from the group consisting of a substitution at nucleotides 476-478 of SEQ ID No 1, a substitution at nucleotides 482-484 of SEQ ID No 1, a substitution at nucleotides 488-490 of SEQ ID No 1, a substitution at nucleotides 485-490 of SEQ ID No 1, a substitution at nucleotides 548-553 of SEQ ID No 1, a substitution at nucleotides 479-481, 491-493 and 578-580 of SEQ ID No 1, a substitution at nucleotides 620-622 of SEQ ID No 1, a substitution at nucleotides 656-658 of SEQ ID No 1, a substitution at nucleotides 671-673 of SEQ ID No 1, a substitution at nucleotides 920-922 of SEQ ID No 1, and a substitution at nucleotides 1193-1195 of SEQ ID No 1. [0032] The invention also concerns an isolated or recombinant PCSK9 gene or fragment thereof comprising at least one alteration, wherein said alteration is selected from the group consisting of the polymorphisms listed in Table 2 and in Table 4. [0033] The invention relates to an isolated or purified NARC-1 protein or a fragment thereof comprising an alteration, wherein said alteration reduces, modifies or abolishes the activity of NARC-1. Preferably, the alteration is located at the catalytic site of the NARC-1 protein and decreases its catalytic activity or at a zymogen processing site of NARC-1 and decreases its autocatalytic cleavage. In an other preferred embodiment, the alteration is located near the catalytic site of the NARC-1 protein and decreases its catalytic activity or near the zymogen processing sites of NARC-1 and decreases its autocatalytic cleavage. More preferably, said alteration can be selected from the group consisting of a substitution of the residue Serine at position 127, a substitution of the residue Phenylalanine at position 216 and a combination thereof. Still more preferably, said alteration is selected from the group consisting of a substitution of the residue Serine at position 127 of SEQ ID No 2 by an Arginine (S127R), a substitution of the residue Phenylalanine at position 216 of SEQ ID No 2 by a Leucine (F216L) and a combination thereof. In a further embodiment, said alteration is selected from the group consisting of a substitution of the residue Tyrosine at position 78 of SEQ ID No 2, a substitution of the residue Valine at position 80 of SEQ ID No 2, a substitution of the residue Leucine at position 82 of SEQ ID No 2, a substitution of the residues Valine at positions 79, 80 and 81 of SEQ ID No 2, a substitution of the residues Alanines at positions 102 and 103 of SEQ ID No 2, a substitution of the residues Valine at position 79, Lysine at position 83, and Leucine at position 112 of SEQ ID No 2, a substitution of the residue Methionine at position 126 of SEQ ID No 2, a substitution of the residue Proline at position 138 of SEQ ID No 2, a substitution of the residue Isoleucine at position 143 of SEQ ID No 2, a substitution of the residue Histidine at position 226 of SEQ ID No 2, and a substitution of the residue Asparagine at position 317 of SEQ ID No 2. Preferably, said alteration is selected from the group consisting of a substitution of the residue Tyrosine at position 78 of SEQ ID No 2 by an Alanine (Y78A), a substitution of the residue Valine at position 80 of SEQ ID No 2 by an Alanine or a Leucine (V80A or V80L), a substitution of the residue Leucine at position 82 of SEQ ID No 2 by an Alanine, a Valine or a Proline (L82A, L82V or L82P), a substitution of the residues Valine at positions 79, 80 and 81 of SEQ ID No 2 by an Arginine, an Arginine and a Leucine, respectively (V79R, V80R and V81L), a substitution of the residues Alanines at positions 102 and 103 of SEQ ID No 2 by Arginines (A102R and A103R), a substitution of the residues Valine at position 79, Lysine at position 83, and Leucine at position 112 of SEQ ID No 2 by an Isoleucine, a Methionine, a Proline, respectively (V79I, K83M and L112P), a substitution of the residue Methionine at position 126 of SEQ ID No 2 by an Alanine (M126A), a substitution of the residue Proline at position 138 of SEQ ID No 2 by a Tyrosine (P138Y), a substitution of the residue Isoleucine at position 143 of SEQ ID No 2 by a Proline (I143P), a substitution of the residue Histidine at position 226 of SEQ ID No 2 by an Alanine (H226A), and a substitution of the residue Asparagine at position 317 of SEQ ID No 2 by an Alanine (N317A). Alternatively, said alteration can be selected from the group consisting of a substitution of the residue Arginine at position 218 of SEQ ID No 2, a substitution of the residue Arginine at position 237 of SEQ ID No 2 and a combination thereof, more preferably a substitution of the residue Arginine at position 218 of SEQ ID No 2 by a Serine (R218S) or a substitution of the residue Arginine at position 237 of SEQ ID No 2 by a Tryptophane (R237W) or a combination thereof. [0034] The invention also relates to an isolated or purified NARC-1 protein or a fragment thereof comprising an alteration, wherein said alteration is selected from the group consisting of an insertion of a residue Leucine at position 15 of SEQ ID No 2, a substitution of the residue Arginine at position 46 of SEQ ID No 2 by a Leucine (R46L), a substitution of the residue Alanine at position 53 of SEQ ID No 2 by a Valine (A53V), a substitution of the residue Isoleucine at position 474 of SEQ ID No 2 by a Valine (1474V), a substitution of the residue Glutamic acid at position 670 of SEQ ID No 2 by a Glycine (E670G) and a comination thereof. The invention also relates to an isolated or purified NARC-1 protein or a fragment thereof comprising an alteration disclosed in Table 4. [0035] The invention further relates to a recombinant nucleic acid encoding a NARC-1 protein or a fragment thereof comprising an alteration according to the present invention, a vector comprising said nucleic acid, a host cell comprising said vector or said recombinant nucleic acid, and a non-human host organism comprising said recombinant nucleic acid, said vector or said host cell. [0036] Therefore, the invention concerns an isolated or recombinant PCSK9 gene and/or NARC-1 protein comprising an alteration causing hypercholesterolemia, more particularly ADH, said alteration reducing, modifying or abolishing the activity of NARC-1. In this context, by modifying is intended a change of specificity of the NARC-1 protein. Optionally, said alteration decreases or abolishes the stability of the NARC-1 protein. Optionally, said alteration decreases or abolishes the stability of MRNA encoding NARC-1. Optionally, said alteration reduces the transcription rate of the PCSK9 gene. Optionally, said alteration decreases or abolishes the activity of the NARC-1 protein. Optionally, said alteration decreases or abolishes the specificity of NARC-1 for at least one of its natural substrates. Optionally, said alteration introduces a new specificity of NARC-1 for an unusual substrate. Said unusual substrate is preferably involved in cholesterol and/or lipoprotein metabolism. Optionally, said alteration hinders or prevents the NARC-1 polymerization. Optionally, said alteration affects the catalytic site of NARC-1. Optionally, said alteration affects substrate recognition site of NARC-1. Optionally, said alteration affects the processing of pro-NARC-1 in NARC-1. More particularly, said alteration reduces or prevents the autocatalytic cleavage at one of the two zymogen processing sites or at both zymogen processing sites. Optionally, said alteration modifies the association between the NARC-1 and its prosegment, for example by increasing or decreasing their interaction. [0037] By “decrease”, it is intended within the context of this invention that the assessed parameter is between 10% and 90% of the parameter value with a wild-type NARC-1 protein in a wild-type environment. More preferably, said assessed parameter is between 25% and 75% of the parameter value with a wild-type NARC-1 protein in a wild-type environment. By “abolish”, it is intended within the context of this invention that the assessed parameter is less than 10% of the parameter value with a wild-type NARC-1 protein in a wild-type environment. More preferably, said assessed parameter is less than 5% of the parameter value with a wild-type NARC-1 protein in a wild-type environment. Still more preferably, said assessed parameter is less than 1% of the parameter value with a wild-type NARC-1 protein in a wild-type environment. [0038] In a particular embodiment, said alteration decreases or abolishes the catalytic activity of NARC-1. Preferably, said alteration is located near the catalytic site of the NARC-1 protein. Preferably, this alteration is located near a residue of the catalytic site selected from the group consisting of Aspartic acid at position 186, Serine at position 188, Histidine at position 226, Asparagine at position 317 and Serine at position 386. More preferably, this alteration is located near the histidine in position 226. Alternatively, said alteration can be located at one or several residues of the catalytic site selected from the group consisting of Aspartic acid at position 186, Serine at position 188, Histidine at position 226, Asparagine at position 317 and Serine at position 386. [0039] In an other preferred embodiment, said alteration decreases the autocatalytically cleavage of the NARC-1 protein. Preferably, said alteration is located near the zymogen processing sites of NARC-1. Said zymogen processing sites are located at positions 78-82 and 138-142. Alternatively, said alteration can be located at one or several residues of the zymogen processing sites of NARC-1. [0040] In terms of amino acid sequence, the term “near” designates,within the context of this invention, an alteration located at less than 90 amino acids, preferably 60-30 amino acids, more preferably 20 amino acids, from one residue of the catalytic site or the zymogen processing site. It is also intended that the term “near” does not include residues that form part of the catalytic site or of the zymogen processing site, as defined in the present invention. [0041] In terms of nucleotide sequence, the term “near” indicates that the alteration is located at less than 270 nucleotides, preferably 180-90 nucleotides, more preferably 60 nucleotides, from one nucleotide comprised in a codon encoding a residue of the catalytic site or of the zymogen processing site. Such alteration preferably changes the codon, thereby changing the amino acid at that position in the protein sequence. [0042] In a particular embodiment, the invention concerns an isolated or recombinant PCSK9 gene and/or an isolated or purified NARC-1 protein comprising an alteration, said alteration being preferably located at the following positions: 1-30, 32-66, 68-77, 83-225, 227-532 and 534-692 of SEQ ID No 2. [0043] Said alteration of the PCSK9 gene can be a mutation (e.g., a nucleotide substitution), a deletion or an addition of at least one nucleotide. Preferably, said alteration is a point mutation. More preferably, said mutation is selected from the group consisting of a substitution of the nucleotide at position 625 and/or 890. More preferably, said mutation is selected from the group consisting of a T→A substitution at nucleotide 625 of SEQ ID No 1, a T→C substitution at nucleotide 890 of SEQ ID No 1 and a combination thereof. In this regard, a specific object of the invention concerns a polynucleotide sequence of SEQ ID No 1 or a polynucleotide comprising a fragment of SEQ ID No 1, said polynucleotide comprising either the nucleotide A at position 625 or the nucleotide C at position 890 or a combination thereof. An other specific object of the present invention concerns a polynucleotide sequence of SEQ ID No 3 or a polynucleotide comprising a fragment of SEQ ID No 3, said polynucleotide comprising either the nucleotide A at position 5158 or the nucleotide C at position 13539 or a combination thereof. [0044] A fragment of a PCSK9 gene designates any portion of at least about 8 consecutive nucleotides of a sequence as disclosed above, preferably at least about 15, more preferably at least about 20 nucleotides, further preferably of at least 30 nucleotides. Fragments include all possible nucleotide length between 8 and 100 nucleotides, preferably between 15 and 100, more preferably between 20 and 100. Said fragment can be useful as primer or probe for identifying an alteration of the PCSK9 gene in a sample of a subject or for genotyping a PCSK9 polymorphism, preferably a polymorphism disclosed in Table 2. Said fragment can be a reagent of a diagnostic kit. [0045] The alteration of the NARC-1 protein can be a substitution, a deletion or an addition of at least one amino acid. Preferably, said alteration is a substitution. More preferably, said substitution is selected from the group consisting of a substitution of the residue Serine at position 127 of SEQ ID No 2, a substitution of the residue Phenylalanine at position 216 of SEQ ID No 2 and a combination thereof. Still more preferably, said substitution is selected from the group consisting of a substitution of the residue Serine at position 127 of SEQ ID No 2 by an Arginine (S127R), a substitution of the residue Phenylalanine at position 216 of SEQ ID No 2 by a Leucine (F216L) and a combination thereof. In this respect, a specific object of this invention concerns a polypeptide sequence of SEQ ID No 2 or a polypeptide comprising a fragment of SEQ ID No 2, said polypeptide comprising either the residue Arginine at position 127 or the residue Leucine at position 216 or a combination thereof. The invention also concerns a polynucleotide encoding said altered NARC-1 protein. [0046] A fragment of a NARC-1 protein designates any portion of at least about 8 consecutive amino acids of a sequence as disclosed above, preferably at least about 15, more preferably at least about 20 amino acids, further preferably of at least 30 amino acids. Fragments include all possible nucleotide length between 8 and 100 amino acids, preferably between 15 and 100, more preferably between 20 and 100. Said fragment can be useful for preparing antibodies. [0047] The invention also relates to an antibody specific of a NARC-1 protein comprising an alteration according to the present invention. In a preferred embodiment, said alteration causes hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. More preferably, the invention relates to an antibody specific of a NARC-1 protein comprising a substitution of the residue Serine at position 127 of SEQ ID No 2 by an Arginine (S127R) or a substitution of the residue Phenylalanine at position 216 of SEQ ID No 2 by a Leucine (F216L) or a combination thereof. Furthermore, the invention relates to an antibody specific of a NARC-1 protein comprising an alteration selected from the group consisting of an insertion of a residue Leucine at position 15 of SEQ ID No 2, a substitution of the residue Arginine at position 46 of SEQ ID No 2 by a Leucine (R46L), a substitution of the residue Alanine at position 53 of SEQ ID No 2 by a Valine (A53V), a substitution of the residue Isoleucine at position 474 of SEQ ID No 2 by a Valine (I474V), a substitution of the residue Glutamic acid at position 670 of SEQ ID No 2 by a Glycine (E670G) and a comination thereof. Moreover, the invention relates to an antibody specific of a NARC-1 protein comprising an alteration disclosed in Table 4, preferably selected from the group consisting of a substitution of the residue Tyrosine at position 78 of SEQ ID No 2, a substitution of the residue Valine at position 80 of SEQ ID No 2, a substitution of the residue Leucine at position 82 of SEQ ID No 2, a substitution of the residues Valine at positions 79, 80 and 81 of SEQ ID No 2, a substitution of the residues Alanines at positions 102 and 103 of SEQ ID No 2, a substitution of the residues Valine at position 79, Lysine at position 83, and Leucine at position 112 of SEQ ID No 2, a substitution of the residue Methionine at position 126 of SEQ ID No 2, a substitution of the residue Proline at position 138 of SEQ ID No 2, a substitution of the residue Isoleucine at position 143 of SEQ ID No 2, a substitution of the residue Histidine at position 226 of SEQ ID No 2, and a substitution of the residue Asparagine at position 317 of SEQ ID No 2. More preferably, said alteration is selected from the group consisting of a substitution of the residue Tyrosine at position 78 of SEQ ID No 2 by an Alanine (Y78A), a substitution of the residue Valine at position 80 of SEQ ID No 2 by an Alanine or a Leucine (V80A or V80L), a substitution of the residue Leucine at position 82 of SEQ ID No 2 by an Alanine, a Valine or a Proline (L82A, L82V or L82P), a substitution of the residues Valine at positions 79, 80 and 81 of SEQ ID No 2 by an Arginine, an Arginine and a Leucine, respectively (V79R, V80R and V81L), a substitution of the residues Alanines at positions 102 and 103 of SEQ ID No 2 by Arginines (A102R and A103R), a substitution of the residues Valine at position 79, Lysine at position 83, and Leucine at position 112 of SEQ ID No 2 by an Isoleucine, a Methionine, a Proline, respectively (V791, K83M and L112P), a substitution of the residue Methionine at position 126 of SEQ ID No 2 by an Alanine (M126A), a substitution of the residue Proline at position 138 of SEQ ID No 2 by a Tyrosine (P138Y), a substitution of the residue Isoleucine at position 143 of SEQ ID No 2 by a Proline (I143P), a substitution of the residue Histidine at position 226 of SEQ ID No 2 by an Alanine (H226A), and a substitution of the residue Asparagine at position 317 of SEQ ID No 2 by an Alanine (N317A). By “specific” is intended binds specifically the altered polypeptide and essentially does not bind specifically the wild-type polypeptide or the binding of the two forms can be discriminated. [0048] Another object of the present invention is an altered PCSK9 gene having at least one nucleotide mutation at a position listed in Table 2. More particularly, the invention concerns an altered PCSK9 gene having the Leucine stretch modification, the corresponding encoded NARC-1 protein and the use thereof. [0049] A further aspect of this invention resides in novel products for use in diagnosis, therapy or screening of hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. These products comprise nucleic acid molecules encoding a NARC-1 polypeptide according to the present invention, vectors comprising the same, recombinant host cells and expressed polypeptides. [0050] A further object of this invention is a vector comprising a nucleic acid encoding a NARC-1 polypeptide comprising an alteration according to the present invention. The vector may be a cloning vector or, more preferably, an expression vector, i.e., a vector comprising regulatory sequences causing expression of a NARC-1 polypeptide from said vector in a competent host cell. [0051] These vectors can be used to express a NARC-1 polypeptide according to the present invention in vitro, ex vivo or in vivo, to create transgenic or “Knock Out” non-human animals, to amplify the nucleic acids, to express antisense RNAs, etc. [0052] The vectors of this invention typically comprise a NARC-1 coding sequence according to the present invention operably linked to regulatory sequences, e.g., a promoter, a polyA, etc. The term “operably linked” indicates that the coding and regulatory sequences are functionally associated so that the regulatory sequences cause expression (e.g., transcription) of the coding sequences. The vectors may further comprise one or several origins of replication and/or selectable markers. The promoter region may be homologous or heterologous with respect to the coding sequence, and provide for ubiquitous, constitutive, regulated and/or tissue specific expression, in any appropriate host cell, including for in vivo use. Examples of promoters include bacterial promoters (T7, pTAC, Trp promoter, etc.), viral promoters (LTR, TK, CMV-IE, etc.), mammalian gene promoters (albumin, PGK, etc), and the like. [0053] The vector may be a plasmid, a virus, a cosmid, a phage, a BAC, a YAC, etc. Plasmid vectors may be prepared from commercially available vectors such as pBluescript, pUC, pBR, etc. Viral vectors may be produced from baculoviruses, retroviruses, adenoviruses, AAVs, etc., according to recombinant DNA techniques known in the art. [0054] In this regard, a particular object of this invention resides in a recombinant virus encoding an altered NARC-1 polypeptide according to the present invention. The recombinant virus is preferably replication-defective, even more preferably selected from E1- and/or E4-defective adenoviruses, Gag-, pol- and/or env-defective retroviruses and Rep- and/or Cap-defective AAVs. Such recombinant viruses may be produced by techniques known in the art, such as by transfecting packaging cells or by transient transfection with helper plasmids or viruses. Typical examples of virus packaging cells include PA317 cells, PsiCRIP cells, GPenv+cells, 293 cells, etc. Detailed protocols for producing such replication-defective recombinant viruses may be found for instance in W095/14785, W096/22378, U.S. Pat. No. 5,882,877, U.S. Pat. No. 6,013,516, U.S. Pat. No. 4,861,719, U.S. Pat. No. 5,278,056 and W094/19478. [0055] A further object of the present invention resides in a recombinant host cell comprising a recombinant PCSK9 gene according to the present invention or a vector as defined above. Suitable host cells include, without limitation, prokaryotic cells (such as bacteria) and eukaryotic cells (such as yeast cells, mammalian cells, insect cells, plant cells, etc.). Specific examples include E.coli, Kluyveromyces or Saccharomyces yeasts, mammalian cell lines (e.g., Vero cells, CHO cells, 3T3 cells, COS cells, etc.) as well as primary or established mammalian cell cultures (e.g., produced from lymphoblasts, fibroblasts, embryonic cells, epithelial cells, nervous cells, adipocytes, etc.). More particularly, the invention contemplates liver and small intestine and cells thereof or derived thereof. [0056] The present invention also relates to a method for producing a recombinant host cell expressing a NARC-1 polypeptide comprising an alteration according to the present invention, said method comprising (i) introducing in vitro or ex vivo into a competent host cell a recombinant nucleic acid or a vector as described above, (ii) culturing in vitro or ex vivo the recombinant host cells obtained and (iii), optionally, selecting the cells which express and/or secrete said NARC-1 polypeptide. [0057] Such recombinant host cells can be used for the production of NARC-1 polypeptides according to the present invention, as well as for screening of active molecules, as described below. Such cells may also be used as a model system to study hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. These cells can be maintained in suitable culture media, such as DMEM, RPMI, HAM, etc., in any appropriate culture device (plate, flask, dish, tube, pouch, etc.). [0058] Diagnosis [0059] The invention now provides diagnosis methods based on a monitoring of alteration at the PCSK9 gene locus in a subject. Within the context of the present invention, the term “diagnosis” includes the detection, monitoring, dosing, comparison, etc., at various stages, including early, pre-symptomatic stages, and late stages, in adults, children and pre-birth. Diagnosis typically includes the prognosis, the assessment of a predisposition or risk of development, the characterization of a subject to define most appropriate treatment (pharmaco-genetics), etc. [0060] A particular object of this invention resides in a method of detecting the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject, the method comprising (i) providing a sample from the subject and (ii) detecting the presence of an alteration in the PCSK9 gene locus in said sample, the presence of said alteration is indicative of the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. Preferably, said alteration is a nucleotide substitution. More preferably, the invention concerns a method of detecting the presence of or predisposition to ADH. [0061] A particular object of this invention resides in a method of detecting the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject, the method comprising (i) providing a sample from the subject and (ii) detecting the presence of an alteration in the NARC-1 MRNA in said sample, the presence of said alteration is indicative of the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. Preferably, said alteration is a nucleotide substitution. More preferably, the invention concerns a method of detecting the presence of or predisposition to ADH. [0062] An additional particular object of this invention resides in a method of detecting the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject, the method comprising (i) providing a sample from the subject and (ii) detecting the presence of an alteration in the NARC-1 polypeptide in said sample, the presence of said alteration is indicative of the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. Preferably, said alteration is an amino acid substitution. More preferably, the invention concerns a method of detecting the presence of or predisposition to ADH. [0063] An other particular object of this invention resides in a method of assessing the response of a subject to a treatment of hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders, the method comprising (i) providing a sample from the subject and (ii) detecting the presence of an alteration in the PCSK9 gene locus, in the NARC-1 MRNA or in the NARC-1 polypeptide in said sample, the presence of said alteration is indicative of a particular response to said treatment. Preferably, said alteration is a nucleotide or amino acid substitution. More preferably, the invention concerns a method of assessing the response of a subject to a treatment of ADH. [0064] A further object of the present invention resides in a method of detecting the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject, the method comprising (i) providing a sample from the subject and (ii) detecting the presence of an alteration in the PCSK9 gene, the LDL receptor gene and/or the apolipoprotein B gene in said sample, the presence of said alteration is indicative of the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. Similarly, the alteration can also be detected at the protein level. More preferably, the invention concerns a method of detecting the presence of or predisposition to ADH. [0065] An alteration in the gene may be any form of mutation(s), deletion(s), rearrangement(s) and/or insertions in the coding and/or non-coding region of the locus, alone or in various combination(s). Mutations more specifically include point mutations, as disclosed above. In a preferred embodiment of the present invention, the alteration is a nucleotide or amino acid substitution. [0066] The detection of the presence of an altered PCSK9 gene or an altered NARC-1 MRNA sequence according to the present invention can be performed by sequencing all or part of the PCSK9 gene, polypeptide or RNA, by selective hybridisation or by selective amplification, for instance. [0067] A more specific embodiment comprises detecting the presence of a polymorphism as disclosed in Table 2 in the PCSK9 gene sequence or NARC-1 mRNA of a subject. [0068] More particularly, the alteration of the PCSK9 gene locus is detected through an haplotype segregating with the mutation causing ADH, more preferably the haplotype (polymorphisms B (absence of insertion), H, I, M and U of Table 2). [0069] Preferably, the alteration detected in the PCSK9 gene locus or NARC-1 mRNA is selected from the group consisting of a substitution of the nucleotide T at position 625 and 890 of SEQ ID No 1 and a combination thereof, more preferably a T→A substitution at position 625 of SEQ ID No 1, a T→C substitution at position 890 of SEQ ID No 1 and a combination thereof. [0070] Alternatively, the alteration detected in the PCSK9 gene locus or NARC-1 mRNA can also be selected from the group consisting of a substitution of the nucleotide A at position 898 and a substitution of the nucleotide C at position 953 of SEQ ID No 1 and a combination thereof, more preferably a A→T substitution at position 898 of SEQ ID No 1, a C→T substitution at position 953 of SEQ ID No 1 and a combination thereof. [0071] Preferably, the alteration detected in the NARC-1 protein is selected from the group consisting of a substitution of the residue Serine at position 127 of SEQ ID No 2, a substitution of the residue Phenylalanine at position 216 of SEQ ID No 2 and a combination thereof, more preferably a substitution of the residue Serine at position 127 of SEQ ID No 2 by an Arginine (S127R) or a substitution of the residue Phenylalanine at position 216 of SEQ ID No 2 by a Leucine (F216L) or a combination thereof. [0072] Alternatively, the alteration detected in the NARC-1 protein can also be selected from the group consisting of a substitution of the residue Arginine at position 218 of SEQ ID No 2, a substitution of the residue Arginine at position 237 of SEQ ID No 2 and a combination thereof, more preferably a substitution of the residue Arginine at position 218 of SEQ ID No 2 by a Serine (R218S) or a substitution of the residue Arginine at position 237 of SEQ ID No 2 by a Tryptophane (R237W) or a combination thereof. [0073] An object of the present invention resides in a method of detecting the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject, the method comprising (i) providing a sample from the subject and (ii) detecting the presence of an altered NARC-1 RNA and/or polypeptide expression, the presence of said altered NARC-1 RNA and/or polypeptide expression is indicative of the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. More preferably, the invention concerns a method of detecting the presence of or predisposition to ADH. [0074] An object of the present invention resides in a method of assessing the response of a subject to a treatment of hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject, the method comprising (i) providing a sample from the subject and (ii) detecting the presence of an altered NARC-1 RNA and/or polypeptide expression, the presence of said altered NARC-1 RNA and/or polypeptide expression is indicative of a particular response to said treatment. More preferably, the invention concerns a method of detecting the presence of or predisposition to ADH. [0075] Altered RNA expression includes the presence of an altered RNA sequence, the presence of an altered RNA splicing or processing, the presence of an altered quantity of RNA, etc. These may be detected by various techniques known in the art, including by sequencing all or part of the NARC-1 RNA or by selective hybridisation or selective amplification of all or part of said RNA, for instance. [0076] Altered NARC-1 polypeptide expression includes the presence of an altered polypeptide sequence, the presence of an altered quantity of NARC-1 polypeptide, the presence of an altered tissue distribution, etc. These may be detected by various techniques known in the art, including by sequencing and/or binding to specific ligands (such as antibodies), for instance. [0077] A further object of the present invention resides in a method of detecting the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject, the method comprising (i) providing a sample from the subject and (ii) detecting the presence of an altered NARC-1 activity, the presence of said altered NARC-1 activity is indicative of the presence of or predisposition to hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders. Preferably, said altered NARC-1 activity is a decreased NARC-1 activity. More preferably, the invention concerns a method of detecting the presence of or predisposition to ADH. [0078] A further object of the present invention resides in a method of assessing the response of a subject to a treatment of hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders in a subject, the method comprising (i) providing a sample from the subject and (ii) detecting the presence of an altered NARC-1 activity, the presence of said altered NARC-1 activity is indicative of a particular response to said treatment. Preferably, said altered NARC-1 activity is a decreased NARC-1 activity. More preferably, the invention concerns a method of detecting the presence of or predisposition to ADH. [0079] An object of the present invention resides in a method of genotyping at least one polymorphism of the PCSK9 gene, preferably listed in Table 2, comprising (i) providing a sample from the subject and (ii) determining the identity of the allele of said polymorphism in said sample. Preferably, the identity of the allele is determined by performing a hydridization assay, a sequencing assay, a microsequencing assay, an allele-specific amplification assay. [0080] The present invention also relates to a method of determining the existence of an association between a polymorphism and a disease or disorder, comprising the steps of: (i) genotyping at least one polymorphism of the PCSK9 gene, preferably one listed in Table 2, in a population having said disease or disorder; (ii) genotyping said polymorphism: in a control population; and, (iii) determining whether a statistically significant association exists between said disease or disorder and said polymorphism. [0081] As indicated above, various techniques known in the art may be used to detect or quantify altered PCSK9 gene or RNA expression or sequence, including sequencing, hybridisation, amplification and/or binding to specific ligands (such as antibodies). Other suitable methods include allele-specific oligonucleotide (ASO), allele-specific amplification, Southern blot (for DNAs), Northern blot (for RNAs), single-stranded conformation analysis (SSCA), PFGE, fluorescent in situ hybridization (FISH), gel migration, clamped denaturing gel electrophoresis, heteroduplex analysis, RNase protection, chemical mismatch cleavage, ELISA, radio-immunoassays (RIA) and immuno-enzymatic assays (IEMA). [0082] Some of these approaches (e.g., SSCA and CGGE) are based on a change in electrophoretic mobility of the nucleic acids, as a result of the presence of an altered sequence. According to these techniques, the altered sequence is visualized by a shift in mobility on gels. The fragments may then be sequenced to confirm the alteration. Some others are based on specific hybridization between nucleic acids from the subject and a probe specific for wild-type or altered PCSK9 gene or RNA. The probe may be in suspension or immobilized on a substrate. The probe is typically labelled to facilitate detection of hybrids. By “specific hybridization” is intended a hybridization under stringent conditions. [0083] Some of these approaches are particularly suited for assessing a polypeptide sequence or expression level, such as Northern blot, ELISA and RIA. These latter require the use of a ligand specific for the polypeptide, more preferably of a specific antibody. [0084] Sequencing can be carried out using techniques well known in the art, using automatic sequencers. The sequencing may be performed on the complete PCSK9 gene or, more preferably, on specific domains thereof, typically those known or suspected to carry deleterious mutations or other alterations. [0085] Amplification may be performed according to various techniques known in the art, such as by polymerase chain reaction (PCR), ligase chain reaction (LCR), strand displacement amplification (SDA) and nucleic acid sequence based amplification (NASBA). These techniques can be performed using commercially available reagents and protocols. Preferred techniques use allele-specific PCR or PCR-SSCP. Amplification usually requires the use of specific nucleic acid primers, to initiate the reaction. [0086] In this regard, a particular object of this invention resides in a nucleic acid primer useful for amplifying sequences from the PCSK9 gene or locus. Such primers are preferably complementary to, and hybridize specifically under stringent conditions to nucleic acid sequences in the PCSK9 gene locus. Particular primers are able to specifically hybridise under stringent conditions with a portion of the PCSK9 gene locus that flank a target region of said locus, said region comprising an alteration according to the present invention, more particularly a substitution of the nucleotide T at position 625 and /or 890 of SEQ ID No 1 or a polymorphism listed in Table 2, preferably said target region being altered in certain subjects having ADH. [0087] A aspect of this invention includes a pair of nucleic acid primers, wherein said pair comprises a sense and a reverse primers, and wherein said sense and a reverse primers specifically amplify a PCSK9 gene or RNA or a target region thereof, said region comprising an alteration according to the present invention, more particularly a substitution of the nucleotide T at position 625 and /or 890 of SEQ ID No 1 or a polymorphism listed in Table 2, preferably said target region being altered in certain subjects having hypercholesterolemia, more particularly ADH and/or lipid and lipoprotein metabolism disoders. [0088] In a more specific embodiment, the invention relates to a nucleic acid primer, wherein said primer is complementary to and hybridizes specifically under stringent conditions to a portion of a PCSK9 coding sequence (e.g., gene or RNA), wherein said portion comprising an alteration according to the present invention, more particularly a substitution of the nucleotide T at position 625 and /or 890 of SEQ ID No 1 or a polymorphism listed in Table 2. Preferably, said alteration is present in certain subjects having hypercholesterolemia, more particularly ADH and/or lipid and lipoprotein metabolism disoders. In this regard, particular primers of this invention are specific for altered sequences in a PCSK9 gene or RNA. By using such primers, the detection of an amplification product indicates the presence of an alteration in the PCSK9 gene locus. In contrast, the absence of amplification product indicates that the specific alteration is not present in the sample. More preferably, said primers comprises the nucleotide at position 625 and/or 890 of SEQ ID No 1, or the nucleotide at position 5158 and/or 13539 of SEQ ID No 3. Alternatively, said primers comprises one polymorphism listed in Table 2. [0089] Typical primers of this invention are single-stranded nucleic acid molecules of about 5 to 60 nucleotides in length, more preferably of about 8 to about 25 nucleotides in length. The sequence can be derived directly from the sequence of the PCSK9 gene locus. Perfect complementarity is preferred, to ensure high specificity. However, certain mismatch may be tolerated. [0090] A particular detection technique involves the use of a nucleic acid probe specific for wild-type or altered PCSK9 gene or RNA, followed by the detection of the presence of a hybrid. The probe may be in suspension or immobilized on a substrate or support (as in nucleic acid array or chips technologies). The probe is typically labelled to facilitate detection of hybrids. [0091] In this regard, a particular embodiment of this invention comprises contacting the sample from the subject with a nucleic acid probe specific for an altered PCSK9 gene locus, and assessing the formation of an hybrid. In a particular, preferred embodiment, the method comprises contacting simultaneously the sample with a set of probes that are specific, respectively, for wild type PCSK9 gene locus and for various altered forms thereof. In this embodiment, it is possible to detect directly the presence of various forms of alterations in the PCSK9 gene locus in the sample. Also, various samples from various subjects may be treated in parallel. [0092] A further particular object of this invention resides in a nucleic acid probe specific for a PCSK9 gene or RNA. Within the context of this invention, a probe refers to a polynucleotide sequence which is complementary to and capable of specific hybridisation under stringent conditions with a (target portion of a) PCSK9 gene or RNA, and which is suitable for detecting polynucleotide polymorphisms, preferably the polymorphism associated with PCSK9 alleles which predispose to or are associated with ADH. Probes are preferably perfectly complementary to the PCSK9 gene, RNA, or target portion thereof. Probes typically comprise single-stranded nucleic acids of between 8 to 1000 nucleotides in length, for instance of between 10 and 800, more preferably of between 15 and 700, typically of between 20 and 500. It should be understood that longer probes may be used as well. A preferred probe of this invention is a single stranded nucleic acid molecule of between 8 to 500 nucleotides in length, which can specifically hybridise under stringent conditions to a region of a PCSK9 gene or RNA that carries an alteration. [0093] A specific embodiment of this invention is a nucleic acid probe specific for an altered (e.g., a mutated) PCSK9 gene or RNA, i.e., a nucleic acid probe that specifically hybridises under stringent conditions to said altered PCSK9 gene or RNA and essentially does not hybridise under stringent conditions to a PCSK9 gene or RNA lacking said alteration. Specificity indicates that hybridisation to the target sequence generates a specific signal which can be distinguished from the signal generated through non-specific hybridisation. Perfectly complementary sequences are preferred to design probes according to this invention. It should be understood, however, that certain mismatch may be tolerated, as long as the specific signal may be distinguished from non-specific hybridisation. [0094] Particular examples of such probes are nucleic acid sequences complementary to a target portion of the PCSK9 gene or RNA carrying the nucleotide at position 625 and/or 890 of SEQ ID No 1, the nucleotide at position 5158 and/or 13539 of SEQ ID No 3, a polymorphism listed in Table 2, or a mutation disclosed in Table 4. [0095] The sequence of the probes can be derived from the sequences of the PCSK9 gene and RNA as provided in the present application. Nucleotide substitutions may be performed, as well as chemical modifications of the probe. Such chemical modifications may be accomplished to increase the stability of hybrids (e.g., intercalating groups) or to label the probe. Typical examples of labels include, without limitation, radioactivity, fluorescence, luminescence, enzymatic labelling, etc. [0096] As indicated above, alteration in the PCSK9 gene locus may also be detected by screening for alteration(s) in NARC-1 polypeptide sequence or expression levels. In this regard, a specific embodiment of this invention comprises contacting the sample with a ligand specific for an altered NARC-1 polypeptide and determining the formation of a complex. [0097] Different types of ligands may be used, such as specific antibodies. In a specific embodiment, the sample is contacted with an antibody specific for an altered NARC-1 polypeptide and the formation of an immune complex is determined. Various methods for detecting an immune complex can be used, such as ELISA, radio-immunoassays (RIA) and immuno-enzymatic assays (IEMA). [0098] In a specific embodiment, the method comprises contacting a sample from the subject with (a support coated with) an antibody specific for an altered form of a NARC-1 polypeptide, and determining the presence of an immune complex. In a particular embodiment, the sample may be contacted simultaneously, or in parallel, or sequentially, with various (supports coated with) antibodies specific for different forms of a NARC-1 polypeptide, such as a wild-type and various altered forms thereof. [0099] Particular examples of such specific ligands are antibodies specific for altered NARC-1 polypeptide sequence resulting from any mutation in position 127 and/or 216, more particularly a substitution of the residue Serine at position 127 by an Arginine (S 127R) or a substitution of the residue Phenylalanine at position 216 by a Leucine (F216L) or any combination of those mutations. [0100] The invention also relates to a diagnostic kit comprising products and reagents for detecting in a sample from a subject the presence of an alteration in the PCSK9 gene or in the NARC-1 protein, in the NARC-1 RNA or polypeptide expression, and/or in NARC-1 activity. Optionally, said diagnostic kit further comprises reagents for detecting in a sample from a subject the presence of an alteration in the LDL receptor and/or the apolipoprotein B. Said diagnostic kit according to the present invention comprises any primer, any pair of primers, any nucleic acid probe and/or any antibody described in the present invention. Said diagnostic kit according to the present invention can further comprise reagents and/or protocols for performing a hybridization, amplification or antigen-antibody immune reaction. [0101] SCREENING [0102] The present invention also provides novel targets and methods for the screening of drug candidates or leads. Such drug candidates or leads are useful for developping a treatment against hypercholesterolemia, more particularly ADH, lipid and lipoprotein metabolism disorders, atherosclerosis, and/or CVD. Preferably, such drug candidates or leads are useful for developping a treatment against ADH. The methods include binding assays and/or functional assays, and may be performed in vitro, in cell systems, in animals, etc. Functional assays comprise, but are not limited to, the cleavage of a substrate. The in vitro assays, cell-based assays and animal-based assays involve a NARC-1 protein, preferably a NARC-1 protein comprising an alteration according to the present invention. Optionally, said assays comprise a control with a natural NARC-1 protein. [0103] For cell systems, cells can be native, i.e., cells that normally express the NARC-1 polypeptide, as a biopsy or expanded in cell culture. Preferably, these native cells are derived from liver or small intestine. Alternatively, cells are recombinant host cells expressing NARC-1, more particularly a NARC-1 protein comprising an alteration according to the present invention. [0104] The invention relates to methods for identifying of the target proteins of the NARC-1 protein, preferably a NARC-1 protein comprising an alteration according to the present invention. [0105] The invention relates to methods for screening of compounds that modulate the NARC-1 activity. Such compounds, for example, can increase or decrease affinity and/or rate of binding of the NARC-1 protein to the substrate, compete with substrate for binding to the NARC-1 protein, or displace substrate bound to the NARC-1 protein. Preferably, the invention concerns methods for screening of compounds that increase or restore the natural NARC-1 activity. By “natural” NARC-1 activity is intended the activity of the wild-type NARC-1 protein. Furthermore, the invention concerns methods for screening of compounds that inhibit the activity of the altered NARC-1 comprising an alteration changing the substrate specificity and, thereby generating new substrates. Said compounds are able to block the activity of the altered NARC-1 for its new substrate. [0106] Therefore, the present invention concerns a method of selecting biologically active compounds, said method comprising contacting a test compound with an altered PCSK9 gene or an altered NARC-1 protein or fragment thereof of at least 15 consecutive residues comprising an alteration, wherein the alteration reduces, modifies, or abolishes the activity of NARC-1, and determining the ability of said test compound to modulate the expression and/or activity of said gene or protein or fragment. [0107] A particular object of this invention resides in a method of selecting biologically active compounds, said method comprising contacting in vitro a test compound with a PCSK9 gene or NARC-1 polypeptide, preferably a PCSK9 gene or a NARC-1 polypeptide, or a fragment thereof of at least 15 consecutive residues, comprising an alteration according to the present invention, and determining the ability of said test compound to bind said PCSK9 gene or NARC-1 polypeptide. Binding to said gene or polypeptide provides an indication as to the ability of the compound to modulate the activity of said target, and thus to affect a pathway leading to hypercholeterolemia, more particularly ADH, and lipid and/or lipoprotein metabolism disorders in a subject. In a preferred embodiment, the method comprises contacting in vitro a test compound with a NARC-1 polypeptide or a fragment thereof, preferably a NARC-1 polypeptide or a fragment thereof comprising an alteration according to the present invention, and determining the ability of said test compound to bind said NARC-1 polypeptide or fragment. The fragment preferably comprises a substrate-binding site of the NARC-1 polypeptide. [0108] A particular object of this invention resides in a method of selecting compounds active against hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders, said method comprising contacting in vitro a test compound with a NARC-1 polypeptide or a fragment thereof of at least 15 consecutive residues, preferably a NARC-1 polypeptide or a fragment thereof comprising an alteration according to the present invention, and determining the ability of said test compound to bind said NARC-1 polypeptide or fragment thereof. The NARC-1 polypeptide or fragment thereof may be used in essentially pure form, in suspension, or immobilized on a support. [0109] In a futher particular embodiment, the method comprises contacting a recombinant host cell expressing NARC-1 polypeptide, preferably a NARC-1 polypeptide comprising an alteration according to the present invention, with a test compound, and determining the ability of said test compound to bind said NARC-1 polypeptide and/or to modulate the activity of NARC-1 polypeptide. [0110] The determination of binding may be performed by various techniques, such as by labelling of the test compound, by competition with a labelled reference ligand, two-hybrid Screening Assay, etc. Modulation of activity includes, without limitation, the inhibition or activation of the autocatalytic processing of pro-NARC-1, and/or the inhibition or activation of the substrate cleavage, more particularly a synthetic substrate comprising a zymogenic processing site. [0111] A further object of this invention resides in a method of selecting biologically active compounds, said method comprising contacting in vitro a test compound with a NARC-1 polypeptide, preferably a NARC-1 polypeptide comprising an alteration according to the present invention, and determining the ability of said test compound to modulate the activity of said NARC-1 polypeptide. [0112] A further object of this invention resides in a method of selecting biologically active compounds, said method comprising contacting in vitro a test compound with a PCSK9 gene, preferably a PCSK9 gene comprising an alteration according to the present invention, and determining the ability of said test compound to modulate the expression of said PCSK9 gene. [0113] The invention also concerns methods of selecting biologically active compounds using a non-human transgenic animals expressing a NARC-1 protein, preferably a NARC-1 protein comprising an alteration according to the present invention. Optionally, said non-human transgenic animals can be homozygote or heterozygote for the altered PCSK9 gene. Said methods comprise (i) administrating a test compound to said non-human transgenic animal, and (ii) determining the ability of said test compound to modulate the NARC-1 activity. Said NARC-1 activity can be assessed by determining the plasmatic concentration of cholesterol and/or lipoparticules (VLDL, IDL, LDL), by determining the plasmatic enzymatic activity of NARC-1, by analyzing some tissues (liver, small intestine), by determining the lipoprotein kinetics. The enzymatic activity of NARC-1 can be determined with synthetic substrate, such as described in Seidah et al (2003). [0114] The above screening assays may be performed in any suitable device, such as plates, tubes, dishes, flasks, etc. Typically, the assay is performed in multi-wells plates. Several test compounds can be assayed in parallel. [0115] Furthermore, the test compound may be of various origin, nature and composition. It may be any organic or inorganic substance, such as a lipid, peptide, polypeptide, nucleic acid, small molecule, etc., in isolated or in mixture with other substances. The compounds may be all or part of a combinatorial library of products, for instance. The test compounds can be an antisense or an RNAi. The test compounds can be competitive or suicide substrates. By “suicide substate” is intended a compounds that, after binding NARC-1 protein, the reactive group forms an irreversible bond with NARC-1 rendering it inactive. [0116] Therapy [0117] The invention contemplates methods of treatment of hypercholesterolemia, more particularly ADH, lipid and lipoprotein metabolism disorders, atherosclerosis and/or CVD. Preferably, the invention relates to methods of treatment of hypercholesterolemia, more particularly ADH, and/or lipid and lipoprotein metabolism disorders due to an alteration of NARC-1 protein. [0118] The invention also relates to a method of treating or preventing hypercholesterolemia, more particularly ADH, lipid and lipoprotein metabolism disorders, atherosclerosis and/or CVD in a subject, the method comprising administering to said subject a functional (e.g., wild-type) NARC-1 polypeptide or a nucleic acid encoding the same. More preferably, the invention concerns a method of treating or preventing ADH. [0119] The invention concerns the use of a functional NARC-1 polypeptide or a nucleic acid encoding the same, in the manufacture of a pharmaceutical composition for treating or preventing hypercholesterolemia, more particularly ADH, lipid and lipoprotein metabolism disorders, atherosclerosis and/or CVD in a subject. More preferably, the invention concerns a pharmaceutical composition for treating or preventing ADH. [0120] The invention also relates to a method of treating or preventing hypercholesterolemia, more particularly ADH, lipid and lipoprotein metabolism disorders, atherosclerosis and/or CVD in a subject, the method comprising administering to said subject a compound that modulates NARC-1 expression and/or activity. More preferably, the invention concerns a method of treating or preventing ADH. The invention further relates to a pharmaceutical composition comprising a compound that modulates NARC-1 expression and/or activity. [0121] The invention relates, generally, to the use of a compound that modulates NARC-1 expression and/or activity in the manufacture of a pharmaceutical composition for treating or preventing hypercholesterolemia, more particularly ADH, lipid and lipoprotein metabolism disorders, atherosclerosis and/or CVD in a subject. More preferably, the invention concerns a pharmaceutical composition for treating or preventing ADH. [0122] The present invention demonstrates the causal link between hypercholesterolemia, more particularly ADH, and an alteration of the PCSK9 gene locus. The invention thus provides a novel target of therapeutic intervention. Various approaches can be contemplated to restore or modulate the NARC-1 activity or function, more particularly normal NARC-1 activity or function, in a subject, particularly those carrying an altered PCSK9 gene locus. Supplying wild-type function to such subject is expected to suppress phenotypic expression of hypercholesterolemia, more particularly ADH, in a pathological cell or organism. The supply of such function can be accomplished through gene or protein therapy, or by administering compounds that modulate NARC-1 activity. [0123] If the alteration of NARC-1 protein leads to a decrease or loss of NARC-1 activity, the treatment consists in administering a biologically active compound which increases or restores the NARC-1 activity. Said biologically active compound can be a natural NARC-1 protein. Alternatively, said compound can be an activator of the NARC-1 protein. Said compound can also increase the expression of NARC-1 protein. [0124] If the alteration of NARC-1 protein leads to a new specificity for a substrate, the treatment consists in administrating a biologically active compound which inhibits the activity of the altered NARC-1 protein. Said compound can decrease the expression of NARC-1 protein. For example, such compounds can be an antisens or an RNAi of PCSK9 gene comprising the alteration causing ADH. Alternatively, said compound can be an inhibitor of the altered NARC-1 protein. Said compound can compete with the substrate or can be a suicide substrate. [0125] Further aspects and advantages of the present invention will be disclosed in the following experimental section, which should be regarded as illustrative and not limiting the scope of the present invention. The references cited in the present application are all incoporated herein by reference. EXAMPLE [0126] The inventors mapped a third locus HCHOLA3 at 1p32 and now report two mutations in the PCSK9 gene causing ADH. PCSK9 encodes NARC-1 (neural apoptosis regulated convertase). Its mutations lead to reduced activation of the enzyme. Lipoprotein kinetics in probands revealed an overproduction of apoB100-rich particles showing that the pathogenic origin of the disease is hepatic. In conclusion, NARC-1 is a newly identified human subtilase that contributes to cholesterol homeostasis and is the first example of a dominant disease associated with a defect in a member of the large subtilase family. [0127] To identify the HCHOLA3 locus (formerly FH3), that the inventors mapped (Varret et al, 1999) to 1p34.1-p32 (OMIM603776) and was confirmed by Hunt et al. in a large Utah kindred (Hunt et al, 2000), the inventors performed positional cloning using the originally linked family and 23 French families in which the implication of the LDLR and APOB genes had been excluded. [0128] Family HC92 was identified through the proband (HC92-II-7) who belongs to a multiplex ADH pedigree from which twenty-nine family members were sampled and tested in parametric linkage analyses. In the reduced pedigree studied in the linkage analysis, 12 subjects presented with total cholesterol levels above the 97.5 th percentile when compared with other French individuals matched by age and sex (Steinmetz, 1990) (mean total cholesterol: 3.63 g/L ±0.68, mean LDL-cholesterol: 2.87±0.72 g/L). The inventors excluded linkage to the LDLR and APOB genes [lod scores at −14.05 and −10.01 (θ=0.0), respectively]. The family was genotyped for 8 Genethon markers in the 1p34-p32 region (FIG. 1). The inventors obtained highly significant lod scores with a maximum of 4.26 (θ=0.0) at D1S2742 that reached 4.80 in the multipoint analyses (Table 1, FIG. 3 a ). Haplotype analysis identified a 5.9 Mb critical interval between D1S231 and D1S2890. The critical interval that our team had previously reported in the HC2 family (Varret et al, 1999) was between markers D1S472 and D1S211, thus more distal. Reexamination of haplotype data (FIG. 2) showed that all affected subjects of the HC2 family also shared the same haplotype between markers D1S2722 and D1S2890 except HC2-II-5. This “affected” subject presented a recombinational event at D1S211 thus providing the centromeric boundary of the region described in 1999. Therefore all family members were reinvestigated. HC2-II-5 (who refuses treatment) was the only subject who showed a significant variation (a marked elevation of triglycerides) and thus no longer conforms with the inclusion criteria. [0129] The inventors established the physical map of the candidate region between D1S197 and D1S2890 covered by 82 overlapping BAC sequences released from the Human Genome Project. The region between D1S197 and D1S2890 contains 41 genes among which 8 encode interesting functional candidates with respect to lipid metabolism: EPS 15 (Epidermal growth factor receptor pathway substrate-15), OSBPL9 (Oxysterol binding protein-like 9), SCP2 (Sterol carrier protein 2), LRP8 (Low density lipoprotein receptor-related protein 8), DHCR24 (24-dehydrocholesterol reductase), PRKAA2 (Protein kinase, AMP-activated, alpha 2 catalytic subunit), DAB1 (Disabled homolog 1) and PCSK9 (encoding NARC-1). This Neural Apoptosis Regulated Convertase 1 is a novel putative proprotein convertase (PC) belonging to the subtilase subfamily (Seidah et al, 2003). A related protein is the subtilisin kexin isoenzyme-1 (SKI-1)/site-1-protease (SIP) known to play a key role in cholesterol homeostasis through the processing of the sterol regulatory element-binding proteins (SREBPs) (Brown & Goldstein, 1999; Elagoz et al, 2002). The cDNA spans 3617 bp encoding a 692 amino acid protein. NARC-1 was mapped to 1p33-p34.3. The inventors precisely localized its cDNA using the Blast program (http://www.ncbi.nlm.nih.gov/BLAST/) in the HCHOLA3 interval as follows: tel-D1S231-D1S2661-D1S417-D1S2652-PCSK9-D1S475-D1S200-D1S2742-cen. [0130] Systematic bidirectional sequencing of the 125 exons of the first seven candidates revealed no mutation in probands. By sequencing the 12 exons of PCSK9 the inventors identified in family HC92 a T→A substitution in exon 2 at nucleotide 625 predicting a substitution at codon 127 of Arginine for the conserved Serine (S127R), thereby creating a MnlI cleavage site (FIG. 3 b , FIG. 4). HC92 family members and 100 controls were tested for the substitution. It was absent in the 200 control chromosomes indicating that it is not a polymorphism. It was found in the 12 affected family members and in subject HC92-IV-3 who has a total cholesterol level in the 90 th percentile when compared to other French individuals matched by age and sex. Thus, the penetrance in the family is estimated at 0.94. Interestingly, the S127R mutation was also found in the proband of HC2 and cosegregated with the disease in the family except in subject HC2-II-5, confirming that he had been misclassified in the linkage analyses previously reported (Varret et al, 1999). To assess the possible recurrence of this mutation, the inventors tested 5 intragenic polymorphic markers that the inventors had identified in PCSK9 (4 SNPs and a GCT repeat) in both families. The same haplotype segregated with the S127 R mutation in both the HC2 and the HC92 family: (Polymorphisms B (absence of insertion), H, I, M, and U) (Tables 2 and 3). Furthermore, a unique haplotype was also obtained for the extragenic markers surrounding PCSK9 (D1S2661, D1S417, D1S475, D1S200 and D1S2742) in both families. These results show that despite the absence of records and different geographical origins, the families share a common ancestor. The possibility of a French founder effect was ruled out since the mutation was not found in 22 other French ADH probands. [0131] Through systematic bidirectional sequencing of the 12 exons of the PCSK9 gene in 22 ADH probands, a second mutation (F216L) was identified in the proband of the HC60 family (FIG. 2 c ) who died from myocardial infarction at 49 y.o (FIG. 3 d , FIG. 4). This mutation segregated with the ADH phenotype in the family and was not found in 200 control chromosomes. No major rearrangement was found in any of the probands by Southern blot (data not shown). Thus, mutations in PCSK9 have been found in 12.5% of the ADH families tested. [0132] The inventors also identified 25 polymorphisms present in different probands and on control chromosomes from subjects with normal cholesterol levels (Table 2). These variations and their respective frequencies in the French population are listed in Table 2. It should be noted that none of these polymorphisms give rise to new donor or acceptor splice sites (score calculated according to Senapathy et al.) (Senapathy et al, 1990; Shapiro & Senapathy, 1987). [0133] In order to unravel at the molecular level the consequences of the S127R and F216L mutations, the inventors introduced them in the human PCSK9 cDNA (Seidah et al., 2003). The inventors also obtained four other mutants, namely S127A, S127P, 15 — 16insL (polymorphic variant where an extra leucine is added in the signal peptide hydrophobic stretch) and the active site mutant H226A (Seidah et al., 2003). The cDNAs encoding wild type (WT) NARC-1 and its mutants containing a C-terminal V5 epitope, were transiently transfected in HEK293 cells. A 4h pulse with 35 S-labelled Met and Cys was followed by immunoprecipitation of the cell lysates and the media with a V5 mAb (Seidah et al., 2003). The inventors have previously shown that proNARC-1 is synthesized as a 72 kDa precursor that undergoes two zymogen cleavage events. The first one is rapid and occurs in the endoplasmic reticulum (ER) at the YVVVL 82 ⇓ site, giving rise to the 63-65 kDa N1 product and the 14 kDa prosegment (pro). The second one occurs with much lower efficacy at the putative PHVDY 142 ⇓ site and gives rise to the presumably active 58 kDa N2 enzyme (Brown & Goldstein, 1999). By STORM quantitation the inventors estimate that both S127R and F216L mutations lead to ˜3-fold lower levels of N2. In addition, the secreted level of N1 was about 2-fold lower for the S127R mutant. Interestingly, while the S127A mutant shows a similar behavior, the S127P resembles WT. Finally, the 15 — 16insL allelic variant seems to give rise to a ˜2-fold higher percentage of NI and N2 products, suggesting that more active NARC-1 is produced. [0134] The inventors have identified a new gene implicated in ADH by positional cloning. Linkage analyses were performed on two large French pedigrees: HC92 and HC2 in which the implication of the LDLR and APOB genes had been excluded. A maximum lod score of 4.26 was obtained for D1S2742 in family HC92. Haplotype analysis restricted the region of linkage to a 5.9 Mb interval between markers D1S231 and D1S2890 at 1p32. Our team had previously reported the localization of HCHOLA3 at 1p32-p34.1 by. linkage analysis performed on the HC2 family (Varret et al, 1999). In this family, the critical interval was flanked by markers D1S472 and D1S211 and was thus more distal as compared to the one identified with the HC92 family. Reexamination of haplotype data showed that all affected subjects of the HC2 family also shared the same haplotype between markers D1S2722 and D1S2890 except (HC2-II-5). This “affected” subject presented a recombinational event at D1S211 thus providing the centromeric boundary of the region described in 1999. Therefore (HC2-II-5) was reinvestigated. The new lipid measurements showed the same elevated cholesterol but also marked elevation of triglycerides. This alteration can be explained by recent knowledge of a notable alcohol intake that presently prohibits proper assessment of the subject's status with respect to the family trait. Identification of the S127R PCSK9 gene mutation in all other affected members of the HC2 family and its absence in (HC2-II-5) confirmed that he had been misclassified for the genetic analyses. Identification of the S127R PCSK9 gene mutation in the HC92 family also helped to clarify the genetic status of the 8 children that had been sampled but not included in the linkage analyses. These results comforted the conservative approach that the inventors had chosen (total cholesterol above the 97 . 5 th percentile when compared with sex- and age-matched French population) and that also allowed for reduced penetrance. This last parameter was confirmed since the S127R PCSK9 gene mutation was identified in (HC92-IV-3) who has a total cholesterol level in the 90 th percentile (when compared to other French individuals matched by age and sex), and had higher cholesterol levels when compared to the levels of his non-affected sisters (2.5 th percentile for HC92-IV-1 and 30 th percentile for HC92-IV-2). Thus, the penetrance can now be estimated at 0.94 in the family when considering the inclusion criteria that were applied. This characteristic of a PCSK9 gene mutation is also found with LDLR gene mutations (Hobbs et al, 1989; Sass et al, 1995) and more generally accounts for the variability of the hypercholesterolemic phenotype (evaluated by common clinical and biological criteria) that can be due to the effect of environmental factors or of modifier genes. [0135] Haplotype analysis showed that a unique haplotype segregated with the S127R mutation in both the HC92 and HC2 families. Therefore, it can be assumed that despite the absence of records and different geographical origins, the families share a common ancestor. The possibility of a French founder effect can be ruled out since the mutation was not found in a total of 22 other French probands (data not shown). [0136] NARC-1 is a novel convertase recently cloned by two pharmaceuticals companies (NARC-1, Millenium Pharmaceuticals and LP251, Eli Lilly). It was first identified via the cloning of cDNAs upregulated following apoptosis induced by serum deprivation in primary cerebellar neurons. NARC-1 was more precisely characterized recently by Seidah et al. who used short conserved segments of the SKI-1 catalytic subunit as baits and the Protein Blast program to identify this convertase in a patented database (Seidah et al, 2003). It is synthesized as a soluble zymogen that undergoes autocatalytic intramolecular processing in the endoplasmic reticulum (ER) at the primary cleavage site YVVVL⇓KEE 85 indicative of the enzymatic specificity (Seidah et al, 2003) of NARC-1. Prosegment cleavage is necessary for NARC-1 exit from the ER. The S127R mutation resides between the primary and putative secondary zymogen processing sites of proNARC-1, while F216L is located close to the active site (H226). Notably, the S127R mutation creates an RGD site that may be involved in integrin binding (Ruoslahti, 1996). [0137] While only the S127R mutant causes reduction in the secreted level of N1, both the S127R and the F216L mutations result in reduced production of the enzymatically active N2. Furthermore, the kinetics of VLDL, IDL and LDL apo B 100 performed in ADH subjects carrying the S127R mutation showed an overproduction from the liver of apo B100-rich lipoproteins. Thus, the dominance of the disease shows that NARC-1 is a rate-limiting enzyme involved in cholesterol homeostasis in the liver. Although most enzymopathies are recessively inherited, dominance is reported in some highly regulated or tissue specific enzymes. This is observed in two types of porphyria: AIP (acute intermittent porphyria) (Desnick et al, 1985) and PCT (porphyria cutanea tarda) (Felsher et al, 1982), that are caused by a porphobilinogen deaminase and uroporphyrinogen decarboxylase deficiency, respectively. However, contrary to porphyria, PCSK9 gene defects seem highly penetrant. NARC-1 belongs to the 9-membered mammalian subtilase family in which only one other member was known to carry a disease-causing mutation: a compound heterozygosity in the PC1 gene results in obesity and endocrinopathy due to impaired prohormone processing (MIM 162150). However, heterozygosity for one of the mutations is silent thus suggesting a recessive transmission (Jackson et al, 1997). Although PCs activate a wide variety of proteins, it is notable that none of them was linked so far to a dominant human disease. NARC-1 is thus unique in this respect and may lead to the discovery of others. While the related convertase SKI-1/S1P plays a key role in regulating cholesterol and fatty acid homeostasis through the processing of SREBP1 and SREBP2, the precise implication of NARC-1 in cholesterol homeostasis is still under investigation. Interestingly, NARC-1 is mainly expressed in the liver and small intestine both of which play key roles in cholesterol synthesis and regulation (Seidah et al, 2003). Since apo B 100 levels are regulated post-translationally (Bostrom et al, 1988), it is possible that NARC-1 could inactivate apo B100 and hence decrease the level of LDL. Indeed, a putative site LIEIGL⇓EGK 668 of apo B100 is proposed which would respect the primary and secondary structure requirements of NARC-1 processing selectivity (Seidah et al, 2003). This may thus explain the reported 70 kDa form of apo B100 that is observed to occur under stressful cellular conditions (Cavallo et al, 1999). [0138] The crucial role of NARC-1 is revealed by the hypercholesterolemia that occurs when the gene is mutated resulting in a decreased NARC-1 activation. The identification of NARC-1 substrate(s) will help to elucidate novel disease mechanisms and constitute a target(s) for new intervention strategies to limit elevation of LDL particles and prevent morbidity and mortality from premature atherosclerosis. [0139] Methods [0140] Family Recruitement [0141] The French hypercholesterolemic families were recruited through the 8 lipid clinics of the National Network for ADH (“Réseau National de Recherche sur les Hypercholestérolémies Familiales”). Probands were ascertained among consecutive patients of the clinics. Inclusion criteria for probands were: total cholesterol above the 97.5 th percentile when compared with sex- and age-matched French population (Steinmetz, 1990), LDL cholesterol above 1.9 g/L or 1.6 g/L for children, triglycerides below 1.5 g/L, personal or documented familial xanthomas, and/or arcus corneae, and early CVD. Lipid measurements were repeated to ascertain the existence of primary isolated hypercholesterolemia due to elevated LDL. Family history and pedigrees were investigated. Informed consent was obtained for all subjects included in this study. Family HC2 has been previously reported and described at length (Varret et al, 1999). Functional tests showed normal binding, internalization and degradation of LDL particles in fibroblasts from the probands (HC2-II-9) (Hobbs et al, 1989). Five other families (HC35, HC60, HC92, HC122, HC243) were studied representing 26 affected and 26 unaffected subjects. For affected subjects, mean total and LDL cholesterol were 3.27 g/L ±0.77 and 2.47±0.76 g/L, respectively. [0142] DNA Analysis and Genotyping [0143] DNA was isolated from whole blood samples as previously described (Collod et al, 1994). All families were tested with polymorphic markers of the LDLR and APOB genes. For the LDLR, two intragenic markers (D19S584 in intron 1 and the (TA)n in exon 18) and two flanking markers (D19S394 and D19S221) were studied. The 5′HVR (TG repeat) and 3′HVR (VNTR) were studied for the APOB gene and screening for the R3500Q mutation as reported (Rabes et al, 1997). Genotyping at 1p34-p32 was performed using 11 microsatellites from the Genethon map (D1S472, D1S2722, D1S211, D1S197, D1S231, D1S2661; D1S417, D1S475, D1S200, D1S2742, D1S2890) as reported (Collod et al, 1994). [0144] Linkage Analysis [0145] Parametric linkage analyses were performed with accepted parameters of ADH: dominant transmission of the trait, penetrance of 0.9 for heterozygotes, and a frequency of the disease allele of 1/500. The MLINK and LINKMAP programs (Ott, 1991), and the VITESSE program (O'Connell & Weeks, 1995) were used to perform the two-point and multipoint LOD score analyses. Microsatellite allele frequencies were calculated among the unrelated family members. Linkage was investigated with the assumption of equal female-to-male recombination rates. [0146] Candidate Gene Identification and Analysis [0147] Microsatellites of the 1p34-p32 region were localized on sequences of the Human Genome Project, a physical map of the region was in agreement with the one published by UCSC: http://www.genome.ucsc.edu. Repeat Masker and Genscan programs allowed the prediction and the identification in the Genbank database of positional candidate genes. The Blast program (http://www.ncbi.nlm.nih.gov/BLAST/) was used to localize precisely the candidate genes. The intron/exon structure of the 8 finctional candidates was determined and primers designed with the Mac Vector® software. 137 primer pairs were chosen at approximatively 100 bp surrounding each exon boundary. PCRs were performed with thermostable DNA polymerase from LAROVA Biochemic GmbH (Germany) on GeneAmp® PCR system 9600 (Perkin Elmer). Fluorescent sequencing was carried-out with Big Dye Terminator version 1.0 on GeneAmp® PCR system 9700 (Perkin Elmer) apparatus, under conditions supplied by the manufacturer. Electrophoregrams were analyzed using Sequencing Analysis®3.4 and SeqED®. [0148] PCSK9 Analysis [0149] Primers designed to study the 12 exons of NARC-1, and their conditions of amplification are available on request. Major rearrangements for NARC-1 were investigated by Southern blot as reported (Collot et al, 1994). A rapid detection method of the S127R mutation using PCR amplification followed by digestion by Mnll was developped. After amplification of exon 2, the 543 bp PCR product was digested by 5U MnlI enzyme. After electrophoresis on a 2% agarose gel, fragments of 208, 203 and 60 bp were distinguished in the normal allele, while fragments of 208, 143 and 60 bp appeared in the mutated alleles (the 203 bp normal fragment was divided in fragments of 143 and 60 bp and the two 60 bp fragments generated comigrated). Segregation analysis of this mutation in families HC2 and HC92 and analysis of 200 chromosomes from unaffected persons of French descent were tested both by sequencing and by the Mnll -digestion. [0150] NARC-1 Mutants and Protein Studies [0151] HEK293 cells were transiently transfected with pIRES2 recombinant vectors (Seidah et al, 2003) expressing wild type hNARC-1-V5 (WT) or its mutants H226A, F216L, S127R, S127A, S127P and 15 — 16insL (+L). 24h later the cells were pulse-labeled with [ 35 S] EasyTag Express mix for 4h. Cell extracts and media were immunoprecipitated with a V5 antibody and the precipitates resolved by SDS-PAGE on an 8% Glycine gels. [0152] Accession Numbers for the Genes Tested [0153] EPS15, NM 13 001981; OSBPL9, NM — 024586; SCP2, NM — 002979; LRP8, NM — 004631; DHCR24, NM — 014762; PRKAA2, NM — 006252; DABI, NM — 021080); NARC-1: human AX207686 (gi:15422368); Mus musculus: AX207688; Rattus norvegicus AX207690. References [0154] Austin, M A., King, M C., Bawol, R D., Hulley, S B. & Friedman, G D. Am. J Epidemiol. 125, 308-318 (1987). [0155] Barrett, H. R. et al. Metabolism 47, 484-492 (1998). [0156] Beghin L. et al J. Lipid Res. 41, 1172-1176 (2000). 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J Med. 276, 273-281 (1967): [0168] Frenais, R. et al. Diabetologia. 40, 578-583 (1997). [0169] Ginsberg, H. N., Le, N. A. & Gibson J. C. J Clin. Invest. 75, 614-623 (1985). [0170] Goldstein, J L., Schrott, H G., Hazzard, W R., Bierman, E L. & Motulsky A G. J Clin. Invest. 52, 1544-1568 (1973). [0171] Goldstein, J L. & Brown, M S., Johns Hopkins Med. J 143, 8-16 (1978). [0172] Hobbs, H H., et al. J Clin. Invest. 84, 656-664 (1989). [0173] Hunt, S C. et al . Arterioscler. Thromb. Vasc. Biol. 20, 1089-1093 (2000). [0174] Innerarity, T L. et al. Proc. Natl. Acad. Sci. USA. 84, 6919-6923 (1987). [0175] Jackson, R. S. & al. Nature Genet. 16, 303-306 (1997). [0176] Khachadurian, A K., Am. J Med. 37, 402-407, (1964). [0177] Lusis, A J. Atherosclerosis. Nature. 407, 233-241 (2000). [0178] Maugeais, C., Ouguerram, K., Mahot, P., Krempf, M. & Magot, T., Diabetes Metab. 22, 57-63 (1996). [0179] Maugeais, C., Ouguerram, K., Krernpf, M. & Magot, T. Clin. Chem. Lab. Med. 36, 739-745 (1998). 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[0195] [0195] TABLE 1 Regional lod scores obtained in the HC92 family LOD score at θ Locus Distance 1 0.00 0.001 0.01 0.05 0.10 0.20 0.30 0.40 Z max θ max D1S2722 . . . 2.17 2.17 2.13 1.96 1.75 1.31 0.87 0.44 2.17 0.00 D1S211 0.025 −0.77 1.53 2.46 2.86 2.77 2.22 1.48 0.67 2.86 0.05 D1S197 0.063 −1.73 −1.72 −1.62 −1.20 −0.86 −0.48 −0.26 −0.11 −0.11 0.40 D1S231 0.014 1.08 1.08 1.08 1.06 1.00 0.81 0.57 0.30 1.08 0.00 D1S417 0.036 3.12 3.11 3.08 2.89 2.61 1.93 1.16 0.43 3.12 0.00 D1S200 0.007 2.50 2.49 2.45 2.25 1.98 1.44 0.87 0.33 2.50 0.00 D1S2742 0.007 4.26 4.26 4.21 3.97 3.61 2.67 1.79 0.77 4.26 0.00 D1S2890 0.013 0.84 1.29 2.08 2.54 2.52 2.05 1.35 0.58 2.54 0.05 [0196] [0196] TABLE 2 Polymorphisms identified in the PCSK9 gene Position Polymorp. Nucleotidic SEQ ID Amino acid Nb of indiv. Exon Name Variation N o 3 variation tested Frequency 1 A C→T  916 5′UTR 113 0.119 B Leu stretch 1022-1042 15_16insL 113 0.168 insCTG (+L) C G→T  1116 R46L 113 0.022 D C→T  1120 S47S 113 0.016 E C→T  1137 A53V 113 0.124 2 F T→C  4824 Intronic 100 0.040 3 G G→A  7464 Intronic 25 0.016 4 H G→C 13327 Intronic 100 0.548 I G→C 13349 Intronic 100 0.547 J G→A 13406 Intronic 100 0.063 K G→A 13559 Intronic 100 0.052 L C→A 13626 Intronic 100 0.076 M A→G 13632 Intronic 100 0.382 5 N G→A 13753 Intronic 23 0.020 O C→T 13781 Intronic 23 0.280 P A→G 13932 Intronic 23 0.240 Q A→C 13993 Intronic 23 0.170 8 R T→C 19444 Intronic 20 0.175 9 S T→C 19576 Intronic 113 0.137 T G→A 19657 V460V 113 0.128 U A→G 19697 I474V 113 0.141 10 V C→T 20845 Intronic 24 0.040 W A→G 20846 Intronic 24 0.146 11 X A→G 22769 Intronic 20 0.030 12 Y A→G 24633 E670G 79 0.082 [0197] [0197] TABLE 3 Haplotypes of affected subjects from the three ADH families Markers in 1p32 region PCSK9 Exon 1 Exon 4 Exon 9 Family Mutation D1S417 Polym. B Polym. H Polym. I Polym. M Polym. U D1S200 D1S2742 HC92 S127R 2 No G G A A 3 6 HC2 S127R 2 No G G A A 3 6 HC60 F216L 4 No C C G G — 3 [0198] Marker haplotypes surrounding the mutations of PCSK9: markers are given in physical order from telomere (left) to centromere (right). A common disease haplotype segregates with the S127R mutation in both the HC92 and the HC2 family. TABLE 4 Mutations identified in the PCSK9 gene Nucleotidic Position Amino acid Exon Variation SEQ ID N o 1 variation Effect 1 +CTA  314-316 Insert L23 1 +CTACTA  314-319 Insert LL23, 24 1 CAG→GAG  335-337 Q31N 1 TGC→GCA  443-445 C67A 2 ACC→GCC  473-475 T77A 2 TAC→GCC  476-478 Y78A Inactive zymogen 2 GTG→GCG  479-481 V79A 2 GTG→GCG  482-484 V80A Inactive zymogen 2 GTG→ATT  482-484 V80I 2 GTG→GCG  482-484 V80A 2 GTG→TTG  482-484 V80L Inactive zymogen 2 GTG→GCG  485-487 V81A 2 CTG→GCG  488-490 L82A Inactive zymogen 2 CTG→GTG  488-490 L82V Partially active enzyme 2 CTG→CCG  488-490 L82P Inactive zymogen 2 GTGGTGGTG→  485-490 V79R & V80R Inactive zymogen CGGCGGCTG & V81L 2 GTG→ATT &  479-481 & V79I & K83M Increased zymogen AAG→ATG  491-493 activation 2 GAG→GCG  494-496 E84A None 2 GAG→GCG  497-499 E85A 2 ACC→GCC  500-502 T86A 2 CAC→GCC  503-505 H87A 2 CTC→GCC  506-508 L88A 2 GCTGCC→CGTAGA  548-553 A102R & Inactive zymogen A103R 2 ACC→ATC  569-571 T109I Increased zymogen activation 2 GTG→ATT &  479-481 & V79I & K83M Inactive zymogen AAG→ATG &  491-493 & & CTG→CCG  578-580 L112P 2 ATG→GCG  620-622 M126A Decreased zymogen activation 2 AGT→CGT  623-625 S127R Decreased zymogen activation 2 AGT→GCT  623-625 S127A Decreased zymogen activation 2 AGT→CCT  623-625 S127P None 3 CCC→TAC  656-658 P138Y Decreased zymogen activation 3 ATC→CCC  671-673 I143P Inactive zymogen 4 TTC→CTC  890-892 F216L 4 AGA→AGT  896-898 R218S 5 CAT→GCT  920-922 H226A Inactive zymogen 5 CGC→TGG  953-955 R237W 6 AAC→GCA 1193-1195 N317A Inactive zymogen 10 AAC→GCG/GCA/GCC/ 1841-1843 N533A GCT 10 AAC→CAG 1841-1843 N533Q Loss of N-glycosylation 11 AAC→CAG 2000-2002 N586Q 12 AAC→CAG 2198-2200 N652Q [0199] [0199] 1 3 1 3617 DNA Homo sapiens CDS (245)..(2320) 1 cccacgcgtc cggcctggag gagtgagcca ggcagtgaga ctggctcggg cgggccggga 60 cgcgtcgttg cagcagcggc tcccagctcc cagccaggat tccgcgcgcc ccttcacgcg 120 ccctgctcct gaacttcagc tcctgcacag tcctccccac cgcaaggctc aaggcgccgc 180 cggcgtggac cgcgcacggc ctctaggtct cctcgccagg acagcaacct ctcccctggc 240 cctc atg ggc acc gtc agc tcc agg cgg tcc tgg tgg ccg ctg cca ctg 289 Met Gly Thr Val Ser Ser Arg Arg Ser Trp Trp Pro Leu Pro Leu 1 5 10 15 ctg ctg ctg ctg ctg ctg ctc ctg ggt ccc gcg ggc gcc cgt gcg cag 337 Leu Leu Leu Leu Leu Leu Leu Leu Gly Pro Ala Gly Ala Arg Ala Gln 20 25 30 gag gac gag gac ggc gac tac gag gag ctg gtg cta gcc ttg cgt tcc 385 Glu Asp Glu Asp Gly Asp Tyr Glu Glu Leu Val Leu Ala Leu Arg Ser 35 40 45 gag gag gac ggc ctg gcc gaa gca ccc gag cac gga acc aca gcc acc 433 Glu Glu Asp Gly Leu Ala Glu Ala Pro Glu His Gly Thr Thr Ala Thr 50 55 60 ttc cac cgc tgc gcc aag gat ccg tgg agg ttg cct ggc acc tac gtg 481 Phe His Arg Cys Ala Lys Asp Pro Trp Arg Leu Pro Gly Thr Tyr Val 65 70 75 gtg gtg ctg aag gag gag acc cac ctc tcg cag tca gag cgc act gcc 529 Val Val Leu Lys Glu Glu Thr His Leu Ser Gln Ser Glu Arg Thr Ala 80 85 90 95 cgc cgc ctg cag gcc cag gct gcc cgc cgg gga tac ctc acc aag atc 577 Arg Arg Leu Gln Ala Gln Ala Ala Arg Arg Gly Tyr Leu Thr Lys Ile 100 105 110 ctg cat gtc ttc cat ggc ctt ctt cct ggc ttc ctg gtg aag atg agt 625 Leu His Val Phe His Gly Leu Leu Pro Gly Phe Leu Val Lys Met Ser 115 120 125 ggc gac ctg ctg gag ctg gcc ttg aag ttg ccc cat gtc gac tac atc 673 Gly Asp Leu Leu Glu Leu Ala Leu Lys Leu Pro His Val Asp Tyr Ile 130 135 140 gag gag gac tcc tct gtc ttt gcc cag agc atc ccg tgg aac ctg gag 721 Glu Glu Asp Ser Ser Val Phe Ala Gln Ser Ile Pro Trp Asn Leu Glu 145 150 155 cgg att acc cct cca cgg tac cgg gcg gat gaa tac cag ccc ccc gac 769 Arg Ile Thr Pro Pro Arg Tyr Arg Ala Asp Glu Tyr Gln Pro Pro Asp 160 165 170 175 gga ggc agc ctg gtg gag gtg tat ctc cta gac acc agc ata cag agt 817 Gly Gly Ser Leu Val Glu Val Tyr Leu Leu Asp Thr Ser Ile Gln Ser 180 185 190 gac cac cgg gaa atc gag ggc agg gtc atg gtc acc gac ttc gag aat 865 Asp His Arg Glu Ile Glu Gly Arg Val Met Val Thr Asp Phe Glu Asn 195 200 205 gtg ccc gag gag gac ggg acc cgc ttc cac aga cag gcc agc aag tgt 913 Val Pro Glu Glu Asp Gly Thr Arg Phe His Arg Gln Ala Ser Lys Cys 210 215 220 gac agt cat ggc acc cac ctg gca ggg gtg gtc agc ggc cgg gat gcc 961 Asp Ser His Gly Thr His Leu Ala Gly Val Val Ser Gly Arg Asp Ala 225 230 235 ggc gtg gcc aag ggt gcc agc atg cgc agc ctg cgc gtg ctc aac tgc 1009 Gly Val Ala Lys Gly Ala Ser Met Arg Ser Leu Arg Val Leu Asn Cys 240 245 250 255 caa ggg aag ggc acg gtt agc ggc acc ctc ata ggc ctg gag ttt att 1057 Gln Gly Lys Gly Thr Val Ser Gly Thr Leu Ile Gly Leu Glu Phe Ile 260 265 270 cgg aaa agc cag ctg gtc cag cct gtg ggg cca ctg gtg gtg ctg ctg 1105 Arg Lys Ser Gln Leu Val Gln Pro Val Gly Pro Leu Val Val Leu Leu 275 280 285 ccc ctg gcg ggt ggg tac agc cgc gtc ctc aac gcc gcc tgc cag cgc 1153 Pro Leu Ala Gly Gly Tyr Ser Arg Val Leu Asn Ala Ala Cys Gln Arg 290 295 300 ctg gcg agg gct ggg gtc gtg ctg gtc acc gct gcc ggc aac ttc cgg 1201 Leu Ala Arg Ala Gly Val Val Leu Val Thr Ala Ala Gly Asn Phe Arg 305 310 315 gac gat gcc tgc ctc tac tcc cca gcc tca gct ccc gag gtc atc aca 1249 Asp Asp Ala Cys Leu Tyr Ser Pro Ala Ser Ala Pro Glu Val Ile Thr 320 325 330 335 gtt ggg gcc acc aat gcc cag gac cag ccg gtg acc ctg ggg act ttg 1297 Val Gly Ala Thr Asn Ala Gln Asp Gln Pro Val Thr Leu Gly Thr Leu 340 345 350 ggg acc aac ttt ggc cgc tgt gtg gac ctc ttt gcc cca ggg gag gac 1345 Gly Thr Asn Phe Gly Arg Cys Val Asp Leu Phe Ala Pro Gly Glu Asp 355 360 365 atc att ggt gcc tcc agc gac tgc agc acc tgc ttt gtg tca cag agt 1393 Ile Ile Gly Ala Ser Ser Asp Cys Ser Thr Cys Phe Val Ser Gln Ser 370 375 380 ggg aca tca cag gct gct gcc cac gtg gct ggc att gca gcc atg atg 1441 Gly Thr Ser Gln Ala Ala Ala His Val Ala Gly Ile Ala Ala Met Met 385 390 395 ctg tct gcc gag ccg gag ctc acc ctg gcc gag ttg agg cag aga ctg 1489 Leu Ser Ala Glu Pro Glu Leu Thr Leu Ala Glu Leu Arg Gln Arg Leu 400 405 410 415 atc cac ttc tct gcc aaa gat gtc atc aat gag gcc tgg ttc cct gag 1537 Ile His Phe Ser Ala Lys Asp Val Ile Asn Glu Ala Trp Phe Pro Glu 420 425 430 gac cag cgg gta ctg acc ccc aac ctg gtg gcc gcc ctg ccc ccc agc 1585 Asp Gln Arg Val Leu Thr Pro Asn Leu Val Ala Ala Leu Pro Pro Ser 435 440 445 acc cat ggg gca ggt tgg cag ctg ttt tgc agg act gtg tgg tca gca 1633 Thr His Gly Ala Gly Trp Gln Leu Phe Cys Arg Thr Val Trp Ser Ala 450 455 460 cac tcg ggg cct aca cgg atg gcc aca gcc atc gcc cgc tgc gcc cca 1681 His Ser Gly Pro Thr Arg Met Ala Thr Ala Ile Ala Arg Cys Ala Pro 465 470 475 gat gag gag ctg ctg agc tgc tcc agt ttc tcc agg agt ggg aag cgg 1729 Asp Glu Glu Leu Leu Ser Cys Ser Ser Phe Ser Arg Ser Gly Lys Arg 480 485 490 495 cgg ggc gag cgc atg gag gcc caa ggg ggc aag ctg gtc tgc cgg gcc 1777 Arg Gly Glu Arg Met Glu Ala Gln Gly Gly Lys Leu Val Cys Arg Ala 500 505 510 cac aac gct ttt ggg ggt gag ggt gtc tac gcc att gcc agg tgc tgc 1825 His Asn Ala Phe Gly Gly Glu Gly Val Tyr Ala Ile Ala Arg Cys Cys 515 520 525 ctg cta ccc cag gcc aac tgc agc gtc cac aca gct cca cca gct gag 1873 Leu Leu Pro Gln Ala Asn Cys Ser Val His Thr Ala Pro Pro Ala Glu 530 535 540 gcc agc atg ggg acc cgt gtc cac tgc cac caa cag ggc cac gtc ctc 1921 Ala Ser Met Gly Thr Arg Val His Cys His Gln Gln Gly His Val Leu 545 550 555 aca ggc tgc agc tcc cac tgg gag gtg gag gac ctt ggc acc cac aag 1969 Thr Gly Cys Ser Ser His Trp Glu Val Glu Asp Leu Gly Thr His Lys 560 565 570 575 ccg cct gtg ctg agg cca cga ggt cag ccc aac cag tgc gtg ggc cac 2017 Pro Pro Val Leu Arg Pro Arg Gly Gln Pro Asn Gln Cys Val Gly His 580 585 590 agg gag gcc agc atc cac gct tcc tgc tgc cat gcc cca ggt ctg gaa 2065 Arg Glu Ala Ser Ile His Ala Ser Cys Cys His Ala Pro Gly Leu Glu 595 600 605 tgc aaa gtc aag gag cat gga atc ccg gcc cct cag gag cag gtg acc 2113 Cys Lys Val Lys Glu His Gly Ile Pro Ala Pro Gln Glu Gln Val Thr 610 615 620 gtg gcc tgc gag gag ggc tgg acc ctg act ggc tgc agt gcc ctc cct 2161 Val Ala Cys Glu Glu Gly Trp Thr Leu Thr Gly Cys Ser Ala Leu Pro 625 630 635 ggg acc tcc cac gtc ctg ggg gcc tac gcc gta gac aac acg tgt gta 2209 Gly Thr Ser His Val Leu Gly Ala Tyr Ala Val Asp Asn Thr Cys Val 640 645 650 655 gtc agg agc cgg gac gtc agc act aca ggc agc acc agc gaa gag gcc 2257 Val Arg Ser Arg Asp Val Ser Thr Thr Gly Ser Thr Ser Glu Glu Ala 660 665 670 gtg aca gcc gtt gcc atc tgc tgc cgg agc cgg cac ctg gcg cag gcc 2305 Val Thr Ala Val Ala Ile Cys Cys Arg Ser Arg His Leu Ala Gln Ala 675 680 685 tcc cag gag ctc cag tgacagcccc atcccaggat gggtgtctgg ggagggtcaa 2360 Ser Gln Glu Leu Gln 690 gggctggggc tgagctttaa aatggttccg acttgtccct ctctcagccc tccatggcct 2420 ggcacgaggg gatggggatg cttccgcctt tccggggctg ctggcctggc ccttgagtgg 2480 ggcagcctcc ttgcctggaa ctcactcact ctgggtgcct cctccccagg tggaggtgcc 2540 aggaagctcc ctccctcact gtggggcatt tcaccattca aacaggtcga gctgtgctcg 2600 ggtgctgcca gctgctccca atgtgccgat gtccgtgggc agaatgactt ttattgagct 2660 cttgttccgt gccaggcatt caatcctcag gtctccacca aggaggcagg attcttccca 2720 tggatagggg agggggcggt aggggctgca gggacaaaca tcgttggggg gtgagtgtga 2780 aaggtgctga tggccctcat ctccagctaa ctgtggagaa gcccctgggg gctccctgat 2840 taatggaggc ttagctttct ggatggcatc tagccagagg ctggagacag gtgtgcccct 2900 ggtggtcaca ggctgtgcct tggtttcctg agccaccttt actctgctct atgccaggct 2960 gtgctagcaa cacccaaagg tggcctgcgg ggagccatca cctaggactg actcggcagt 3020 gtgcagtggt gcatgcactg tctcagccaa cccgctccac tacccggcag ggtacacatt 3080 cgcaccccta cttcacagag gaagaaacct ggaaccagag ggggcgtgcc tgccaagctc 3140 acacagcagg aactgagcca gaaacgcaga ttgggctggc tctgaagcca agcctcttct 3200 tacttcaccc ggctgggctc ctcattttta cgggtaacag tgaggctggg aaggggaaca 3260 cagaccagga agctcggtga gtgatggcag aacgatgcct gcaggcatgg aactttttcc 3320 gttatcaccc aggcctgatt cactggcctg gcggagatgc ttctaaggca tggtcggggg 3380 agagggccaa caactgtccc tccttgagca ccagccccac ccaagcaagc agacatttat 3440 cttttgggtc tgtcctctct gttgcctttt tacagccaac ttttctagac ctgttttgct 3500 tttgtaactt gaagatattt attctgggtt ttgtagcatt tttattaata tggtgacttt 3560 ttaaaataaa aacaaacaaa cgttgtccta aaaaaaaaaa aaaaaawaaa aaaaaaa 3617 2 692 PRT Homo sapiens ACT_SITE (186)..(186) Asp 2 Met Gly Thr Val Ser Ser Arg Arg Ser Trp Trp Pro Leu Pro Leu Leu 1 5 10 15 Leu Leu Leu Leu Leu Leu Leu Gly Pro Ala Gly Ala Arg Ala Gln Glu 20 25 30 Asp Glu Asp Gly Asp Tyr Glu Glu Leu Val Leu Ala Leu Xaa Ser Glu 35 40 45 Glu Asp Gly Leu Xaa Glu Ala Pro Glu His Gly Thr Thr Ala Thr Phe 50 55 60 His Arg Cys Ala Lys Asp Pro Trp Arg Leu Pro Gly Thr Tyr Val Val 65 70 75 80 Val Leu Lys Glu Glu Thr His Leu Ser Gln Ser Glu Arg Thr Ala Arg 85 90 95 Arg Leu Gln Ala Gln Ala Ala Arg Arg Gly Tyr Leu Thr Lys Ile Leu 100 105 110 His Val Phe His Gly Leu Leu Pro Gly Phe Leu Val Lys Met Xaa Gly 115 120 125 Asp Leu Leu Glu Leu Ala Leu Lys Leu Pro His Val Asp Tyr Ile Glu 130 135 140 Glu Asp Ser Ser Val Phe Ala Gln Ser Ile Pro Trp Asn Leu Glu Arg 145 150 155 160 Ile Thr Pro Pro Arg Tyr Arg Ala Asp Glu Tyr Gln Pro Pro Asp Gly 165 170 175 Gly Ser Leu Val Glu Val Tyr Leu Leu Asp Thr Ser Ile Gln Ser Asp 180 185 190 His Arg Glu Ile Glu Gly Arg Val Met Val Thr Asp Phe Glu Asn Val 195 200 205 Pro Glu Glu Asp Gly Thr Arg Xaa His Arg Gln Ala Ser Lys Cys Asp 210 215 220 Ser His Gly Thr His Leu Ala Gly Val Val Ser Gly Arg Asp Ala Gly 225 230 235 240 Val Ala Lys Gly Ala Ser Met Arg Ser Leu Arg Val Leu Asn Cys Gln 245 250 255 Gly Lys Gly Thr Val Ser Gly Thr Leu Ile Gly Leu Glu Phe Ile Arg 260 265 270 Lys Ser Gln Leu Val Gln Pro Val Gly Pro Leu Val Val Leu Leu Pro 275 280 285 Leu Ala Gly Gly Tyr Ser Arg Val Leu Asn Ala Ala Cys Gln Arg Leu 290 295 300 Ala Arg Ala Gly Val Val Leu Val Thr Ala Ala Gly Asn Phe Arg Asp 305 310 315 320 Asp Ala Cys Leu Tyr Ser Pro Ala Ser Ala Pro Glu Val Ile Thr Val 325 330 335 Gly Ala Thr Asn Ala Gln Asp Gln Pro Val Thr Leu Gly Thr Leu Gly 340 345 350 Thr Asn Phe Gly Arg Cys Val Asp Leu Phe Ala Pro Gly Glu Asp Ile 355 360 365 Ile Gly Ala Ser Ser Asp Cys Ser Thr Cys Phe Val Ser Gln Ser Gly 370 375 380 Thr Ser Gln Ala Ala Ala His Val Ala Gly Ile Ala Ala Met Met Leu 385 390 395 400 Ser Ala Glu Pro Glu Leu Thr Leu Ala Glu Leu Arg Gln Arg Leu Ile 405 410 415 His Phe Ser Ala Lys Asp Val Ile Asn Glu Ala Trp Phe Pro Glu Asp 420 425 430 Gln Arg Val Leu Thr Pro Asn Leu Val Ala Ala Leu Pro Pro Ser Thr 435 440 445 His Gly Ala Gly Trp Gln Leu Phe Cys Arg Thr Val Trp Ser Ala His 450 455 460 Ser Gly Pro Thr Arg Met Ala Thr Ala Xaa Ala Arg Cys Ala Pro Asp 465 470 475 480 Glu Glu Leu Leu Ser Cys Ser Ser Phe Ser Arg Ser Gly Lys Arg Arg 485 490 495 Gly Glu Arg Met Glu Ala Gln Gly Gly Lys Leu Val Cys Arg Ala His 500 505 510 Asn Ala Phe Gly Gly Glu Gly Val Tyr Ala Ile Ala Arg Cys Cys Leu 515 520 525 Leu Pro Gln Ala Asn Cys Ser Val His Thr Ala Pro Pro Ala Glu Ala 530 535 540 Ser Met Gly Thr Arg Val His Cys His Gln Gln Gly His Val Leu Thr 545 550 555 560 Gly Cys Ser Ser His Trp Glu Val Glu Asp Leu Gly Thr His Lys Pro 565 570 575 Pro Val Leu Arg Pro Arg Gly Gln Pro Asn Gln Cys Val Gly His Arg 580 585 590 Glu Ala Ser Ile His Ala Ser Cys Cys His Ala Pro Gly Leu Glu Cys 595 600 605 Lys Val Lys Glu His Gly Ile Pro Ala Pro Gln Glu Gln Val Thr Val 610 615 620 Ala Cys Glu Glu Gly Trp Thr Leu Thr Gly Cys Ser Ala Leu Pro Gly 625 630 635 640 Thr Ser His Val Leu Gly Ala Tyr Ala Val Asp Asn Thr Cys Val Val 645 650 655 Arg Ser Arg Asp Val Ser Thr Thr Gly Ser Thr Ser Glu Xaa Ala Val 660 665 670 Thr Ala Val Ala Ile Cys Cys Arg Ser Arg His Leu Ala Gln Ala Ser 675 680 685 Gln Glu Leu Gln 690 3 26220 DNA Homo sapiens exon (980)..(1186) exon 1 3 ctggatgctt gtccagttga tttcttgaac atggtgtgta aaaggaatct ttgcaaattg 60 aatcttctgg aaagctgagc ttgtgcctac catagaattc tgaatgtacc tatatgacat 120 ctttgcaaac ttaaaacctg aatctttgta gtataaatcc cttgaaatgc atgtaggctg 180 gacatcaaaa gcaagcaatc tcttcaagga gcagctagtt ggtaaggtca gtgtgcaggg 240 tgcataaagg gcagaggccg gagggggtcc aggctaagtt tagaaggctg ccaggttaag 300 gccagtggaa agaattcggt gggcagcgag gagtccacag taggattgat tcagaagtct 360 cactggtcag caggagacaa ggtggaccca ggaaacactg aaaaggtggg cccggcagaa 420 cttggagtct ggcatcccac gcagggtgag aggcgggaga ggaggagccc ctagggcgcc 480 ggcctgcctt ccagcccagt taggatttgg gagttttttc ttccctctgc gcgtaatctg 540 acgctgtttg gggagggcga ggccgaaacc tgatcctcca gtccgggggt tccgttaatg 600 tttaatcaga taggatcgtc cgatggggct ctggtggcgt gatctgcgcg ccccaggcgt 660 caagcaccca caccctagaa ggtttccgca gcgacgtcga ggcgctcatg gttgcaggcg 720 ggcgccgccg ttcagttcag ggtctgagcc tggaggagtg agccaggcag tgagactggc 780 tcgggcgggc cgggacgcgt cgttgcagca gcggctccca gctcccagcc aggattccgc 840 gcgccccttc acgcgccctg ctcctgaact tcagctcctg cacagtcctc cccaccgcaa 900 ggctcaaggc gccgccggcg tggaccgcgc acggcctcta ggtctcctcg ccaggacagc 960 aacctctccc ctggccctc atg ggc acc gtc agc tcc agg cgg tcc tgg tgg 1012 Met Gly Thr Val Ser Ser Arg Arg Ser Trp Trp 1 5 10 ccg ctg cca ctg ctg ctg ctg ctg ctg ctg ctc ctg ggt ccc gcg ggc 1060 Pro Leu Pro Leu Leu Leu Leu Leu Leu Leu Leu Leu Gly Pro Ala Gly 15 20 25 gcc cgt gcg cag gag gac gag gac ggc gac tac gag gag ctg gtg cta 1108 Ala Arg Ala Gln Glu Asp Glu Asp Gly Asp Tyr Glu Glu Leu Val Leu 30 35 40 gcc ttg cgt tcc gag gag gac ggc ctg gcc gaa gca ccc gag cac gga 1156 Ala Leu Arg Ser Glu Glu Asp Gly Leu Ala Glu Ala Pro Glu His Gly 45 50 55 acc aca gcc acc ttc cac cgc tgc gcc aag gtgcgggtgt aggggtggga 1206 Thr Thr Ala Thr Phe His Arg Cys Ala Lys 60 65 ggccggggcg aacccgcagc cgggacggtg cggtgctgtt tcctctcggg cctcagtttc 1266 cccccatgta agagaggaag tggagtgcag gtcgccgagg gctcttcgct tggcacgatc 1326 ttgaggactg caggcaaggc ggcgggggag gacgggtagt ggggagcacg gtggagagcg 1386 gggacggccg gctctttggg gacttgctgg ggcgtgcggc tgcgctattc agtgggaagg 1446 ttcgcggggt tgggagaccc ggaggccgag gaagggcgag cagagcactg ccaggatatc 1506 ctgcccagat ttcccagttt ctgcctcgcc gcggcacagg tgggtgaagg agtgaatgcc 1566 tggaacgtac tgggaactgc accaggcaca gagaaagcgg gcttgccatt atagtgggtt 1626 ccgatttggt ttggaaaaca tgggcagcgg agggtggagg gcctggagag aaggccctac 1686 ccgagacagg ggcggggtgg gaaggacggc agatgctggg agcacgaggc aatttcttta 1746 tgacacagaa ctcatgctct agtattccat ctgtttcagc cgaagaaaag aaccagctga 1806 aggggcaggg gagaaggggc ggaggtattc tcgaggccca ttggcgtcct ttaggactca 1866 ggcagggaag ggcccttggt gctctggagc cggaggtggt gcgcctggta ctgggacccc 1926 ggagctgagc ccggcgcctc agcccacctg gctgtctgcc gaccgtgtgc ggggcgagtt 1986 tgctcaacaa ctctgccagc ttctggccct caggctgtgg gaagcttctt cccggggcga 2046 gaccactagc tttttctaag tattaccagc ccaggacttg gctgaggttc tgtgtccccc 2106 agcttggagt cagatgtggg gttgaatctt ggcttcctct cactagctgt ggtgcttgac 2166 aagtcactta tccttgagcc tccattgcct aatctttaaa agggaggtga caatcgtccc 2226 tacggctcag tggcagcaga tggggagatg aagggaaagt tctgttgacc atgagtgaac 2286 ttacaatgca agccccgggg ggatcacttg cagttttgtc cctgtctgca gtgtgacctg 2346 ttggtgacat tgtctttgct ccaaaccaca gctcctgggg cagaggggaa aattctgcca 2406 ctcacagctg cctgcccacg cttctgtctg agtgtgctgg gtggcaggat ggcaagtcct 2466 tactcagctc agtatagccc tcttccttgt tccctgagcc tttgactttc tcgagggatg 2526 ttgtggggtt gtggccagga taagaaaggg catttcaagt taccactgct ccaaaacaac 2586 tgttctggaa atagtgagta ccccatcctg agaggtgagt aagcagaggc tgtatgacca 2646 cctgaaccaa gcccttgagg atgtttcttc tctggtggaa gtttggaaca ggagcctcct 2706 caagttcatt tattcattca ttcaatggtt attttgtggg aatcgaattt agaatgaaaa 2766 tattttttgg caagcagaaa ataattttta gaccaatcct tttcttttag tcatgagaaa 2826 ctgaggccca gagagaggag gtcaccccag gtgcattaga actgggtttc cagaactgac 2886 actccactgc acagagtact ctcccaattc attcaatttt tatttagcgg aaggcatttt 2946 cagatgggtc tttgaagcat tagtaggagt tcagcgatga tggtgtcatg agaattttat 3006 tctaggatta ggaggtacca tgaacaaaga tacagagctg ggaaaaccag aggtggaaga 3066 taaggagcac atgtccacag ttctttttct tttttttttg agatggagtt tcgctcttgt 3126 tgcccaggct ggagtgcaat ggtgcagtct cagctcactg caacatctgt ctcccgggtt 3186 caagtggttc tcctgcctca gcctcccaag aagctgggat tacaggtacc tgccaccacg 3246 cccggctaat ttttgtattt ttagtagaga aggggtttca ccacgttggc caggctagtc 3306 gcaaactcct gacctcctca gtggatccga ggaggtgatc ctcccgcctc agcctcccaa 3366 agtgctcgaa ttacaggtgt gagccaccac gcctggcctc cacagttctt tatccaccgt 3426 ctgaaatgta aaatgttacg aaaaccaaaa gttttttttg tgatttattt gatggtagca 3486 cctgacgtga actgacatga gattattttt aatttagttg tgtgaatatg catattcata 3546 tattttgctg catagattac agtatgcagc tccagattct tccaagcaga ctctgattgc 3606 ccattactgc ctttctaaaa tccaaacaag ttctgaggtt caaaaccgat ttggccctaa 3666 ggctttgggt aaagggggtg gactctgttc tactctgact ggagtccaag atgcatatat 3726 acagagatat gggtgatggg gctgcaaggt aggttgaggt aggggccaag gaggagcatg 3786 gagtttggac ttgattcatg aggctgtggg gagccagtga aggttcttaa gcaggtatgt 3846 ctgcctgaga gcagttggag cagacaagag ctaaaaacca aacaaatcac catagatagt 3906 ggctgctata atttgtttgt cccctccaaa tctcatgtgg aaatttggtc ctcagtgttg 3966 gaagtggggc ctaatgggag gtgtttgggt catgggggag gaacccctgt gaaaggcttg 4026 gtgccgtcct tgtgataatg agtaagttct cccgctatga tttcccttga aggctgatta 4086 ttaaaaagag cttggcacct ccctctcttc tctcttgctt cttctcttgc catgtgattg 4146 atctctgcac atgtaggctc cccttcacct tctgccatca gtgaaagcag cttaaggccc 4206 tcaccagaag cagatgctgg tgccatgctt cctggagagc ttgcagaatc atgagctgaa 4266 taaatccctt ttccttgtaa attactcacc ttcaggtatt cctttatata gcaacacaaa 4326 aggactaaga cagtggcctt gacttttctc tctctttaag aagtgttgcc tttgctcact 4386 tagtcatccc ttctgcctgc atttgtagag catctggatg ggagatttat ataaccgtca 4446 ctcttgactt tcccagcagg cctatgtcat aggtactgtg gtctctacaa tacagcagag 4506 gtatctgagg ctccgagagg ttgagtgact tgctcatggc tgcacaacca gtaaatattg 4566 gagctggaat tcaggtccac ggtttcctgg ctccaaagcc catgattttt tccctcaatt 4626 tattctgact ggggcatggg ggagggggtg gcctttgggc agggccacca ggagcgacca 4686 ggcccgtaga gagctgggtg caggtacaga ggaaaacctg ttgtcgagtg tggcccgtag 4746 ttcccatttt tgcctgaatg gcacatttga aagtgttata taaccatgtg aataataata 4806 gttggcctat atgagttttt taatttgctt tttggtccgc atttggtaac ttctttatca 4866 tctactatac tctgttgtgt ctcttttgtt gtaatttgta agtaggggtg agataaagta 4926 cacctagggt ttgctgggtt tcttccatgt catcatgttc ctccttgcat ggggccag 4984 gat ccg tgg agg ttg cct ggc acc tac gtg gtg gtg ctg aag gag gag 5032 Asp Pro Trp Arg Leu Pro Gly Thr Tyr Val Val Val Leu Lys Glu Glu 70 75 80 85 acc cac ctc tcg cag tca gag cgc act gcc cgc cgc ctg cag gcc cag 5080 Thr His Leu Ser Gln Ser Glu Arg Thr Ala Arg Arg Leu Gln Ala Gln 90 95 100 gct gcc cgc cgg gga tac ctc acc aag atc ctg cat gtc ttc cat ggc 5128 Ala Ala Arg Arg Gly Tyr Leu Thr Lys Ile Leu His Val Phe His Gly 105 110 115 ctt ctt cct ggc ttc ctg gtg aag atg agt ggc gac ctg ctg gag ctg 5176 Leu Leu Pro Gly Phe Leu Val Lys Met Ser Gly Asp Leu Leu Glu Leu 120 125 130 gtgagccacc ctttttggga atggcacttc ctgatagggc tgggccactg catatacact 5236 ggggactgtg cttagtaggc ccattgctga aaatcagaag gggacagcaa gtatgtattg 5296 agcacttatc gggtaccaag cacagtaact actggctttc tgtatagaat tccctttaag 5356 cctggccatg ccccagtggt acgtctatct tcatttgaaa gacgaggaga ctgaagttca 5416 gaggggacca cacagacagc taggggtaga gcctggatca aacccattgg tctgcctgcc 5476 agccattctt gtgccaatgc atctgctgcc tacggaaacc tgtagggaca aggccctggg 5536 atgttcagtg gagcctgagt cattttataa aaaagcatga ctctagggtc caaaattcct 5596 ttgaagctgt tgctatccag agtgaagtcc cttctttagg acagggtggc cctcctccct 5656 cctggatgtc acatcttcgg tggaggggca gaaaggggac tgggtattct cctcaccctg 5716 gccctagtgc ttcaaatctt aaaaaaacgt ttttatttgt gcttctgcac caccttctag 5776 cccacctcgt ttcctggcct ctaacttgat gagagcgtgt gtcattttca cactgattct 5836 ccacatggca ggcggtgctt cttagcctcc tgcagacagt gaggccccac ggtcttgtcc 5896 aaggtcacac agcgtgtaat gggcagggtc agagtctgga gtctggacct gggtctccta 5956 gctgcactgc actgctgccc catgggttaa tcagctcagc ataccgtggc tgaacagcta 6016 cctcatacca aggcctgtgg cgccatgaca gggattgaca gggtccctgc cttggaaacc 6076 cgtagtctaa gtagaggaga ctgacaagtc aatgccttcc atcagtctgc tcaacacacg 6136 tttaccaagt gcctactgtg tgctgcagag gcgaagatga cacagctcag gcctttccct 6196 tgagcttaca gttcaggagg agagactgac cagtgactgc cagtacagtt gactatggga 6256 caatgtgctc agccttgggg agagacgaag aaggtacccg tatagcacca gatgacaggc 6316 acgagcccca caggccaggg cagctgctca gaggagagta ggccaagcag aaggcaaaca 6376 gaaggctgca ggcatttgcc atcgagagct ggacttcaaa ctgggcatca taccagcctg 6436 ggttcgagtc ctgcccagcc ccttattggc tgtctaaccc tgagcaaatc ccttcacctc 6496 tctgagcctc attcctctat ctgtaaacca gttataataa ttggaacatt catttaagga 6556 ctaaatgagg tcgtgaagca ttcagcagat gctaggtacg gaaactcgct gaagtggggg 6616 caggttaaga agcctctggg gatacgaagg catccaggga ctagttgtgg caggaggctg 6676 ttaccactta ggtctgaagg gtaaggagag ggaatagctt tccctctgcc cagttggagc 6736 cggtggcatg gaggagaggc tgcctgtggg gaatcacccg agggttcacc gctgccatgc 6796 gcagggagtc aggaggtagg gagggagtgg ggcagatgca caccattttt tttttttttt 6856 gagactctgt tgcccagact ggagtgcagt ggtgccatat ctgcacctct gcctcccggg 6916 ttcaagctca ctgcaacctc tgcctcccgg gttcaagcga ttctcctgcc tcagcctccc 6976 gagtagctgg gactacaggt gtgtgccacc atgcctggct aatttttgta tttttaatag 7036 agatggggtt tcaccatgtt ggccaggctg gtctcgaact ctcgacctca ggtgatcccc 7096 cacctcggcc tcccaaagtg ctgggattac aggcgtgagt caccgctccc agctgctgat 7156 gcactcttgt ccttctaact cctgctagtg cctcccattg gctgagccca actggaagct 7216 ttgcaaggga gctggtgctg cagtttgcac tgagcaggct ggagaaggct ggagaataga 7276 ctaggggaca aaccgaattg ccagtgctgt tatgtcatga tttaggcatg gagtccaggg 7336 cctgagcttc actccatgtc catcctgccc agagccttgg cacagcctgg ctcccagaca 7396 agatgtcaag ttcagaatcc ttcctaaaag gaatcctcta tgccagaccg tgttgcaggg 7456 atatgggggt gctgggctcc cagcctgatc aaggagcgag aaaactcagg ctcctagtct 7516 gtcctccggg gcactagcag ggacaaggtg ggaggctgct gggctgggat gtggggacag 7576 gtttgatcag gtaaggccag gctgtggctg tgtttgctgc tgtccaaatg gcttaagcag 7636 agtcccccgg cctctctggc ttctgcag gcc ttg aag ttg ccc cat gtc gac 7688 Ala Leu Lys Leu Pro His Val Asp 135 140 tac atc gag gag gac tcc tct gtc ttt gcc cag agc atc ccg tgg aac 7736 Tyr Ile Glu Glu Asp Ser Ser Val Phe Ala Gln Ser Ile Pro Trp Asn 145 150 155 ctg gag cgg att acc cct cca cgg tac cgg gcg gat gaa tac cag ccc 7784 Leu Glu Arg Ile Thr Pro Pro Arg Tyr Arg Ala Asp Glu Tyr Gln Pro 160 165 170 ccc g gtaagacccc catctgtgcc ctgccccacc ccatctgagc tgaatccatt 7838 Pro tgctctgccc tggcctggcc tccctgctgg tggtttccac ttctcggggg gctttgggac 7898 tcagcacctc cactgacccc tttttttctg tcccatcccc atcccctgca gcccccactg 7958 cctgccttcc tgttgcccca caaatgcaaa agtcttgcct taaatgatcc tcttttcctc 8018 cttttctctt gttttccttt tctcaccatt tggaatggcc cagcaggctg cacttacctt 8078 ggaaggaggg ttcatctgat ggtgactcta cctagggccc ccaggcctct ataactccca 8138 gtgccctgca gactggacca gatcctttaa tgggatagac acaaccctgt ctgggatgcc 8198 tctgcctacc ttcctgtttt gctgctccac ctgcctccag ctccgtttgg cttcctgggg 8258 ctccctgcct gggccacttt gtgtcttccc tctaggcctt tctttccact gttccctctg 8318 cctggtgtgg cctggctatg gaagggaggg agcaggagcg gccatggaaa acggtctgca 8378 ttctagcagg gacttgcagg tggcaattca gtcggggaag actctagatg cacctggcct 8438 gaggagagaa tgaagggttc tagttggact gtgttaagtt tgaggtgccc atggtgtgag 8498 gtctggagct cagcgcagag atgatgcaat gtggtgggtc catgcaacat ggtgccagga 8558 cgcagagctt ggggtgaact cagctttcac cccttaccgg ttctcgtggg atcttgggaa 8618 gccactttct tctatgagct ttgtcgttct tgtctgtaaa atgggcacat aaccctgtcc 8678 ctgtccttct cacaggttgc tgtgagactc caatgagttg aaggatgtgc agatgctttt 8738 ggaagtgaaa agttgggggg ctactgtgtg actttgcata cacccaaact gtgtgacctt 8798 gcatatgtct gagttgctgc cattgcaaca gatcagagct ggtgggctgg gtgtggagaa 8858 agggtttgtg tgggggacat cctctggcaa gggtggcagc agcagaagtg aggggcctgg 8918 tcggtcatgt gtgctgaccc ggcctgggca gcctgtggcc agggagagga cagctcctct 8978 gtaggaagag cgtgttcctt tccaaccagg tgagacctct tcagtggagc cctggagccc 9038 cctgtactcc acatcagtgc ctcagggacc tcccggagca ggctaatatc agagaccaag 9098 agggacactg gcagaggatc acagagaccc cagtccaggc agggactgag aagatcttgc 9158 cccctaagtt agtttcctag cactgctgtg acaaaatacc accccctcgg ttggaacaag 9218 ttgattctct gcagtcctgg aggccagaag cctgaatcag tgtcggcagg accactttct 9278 cccggggggc tccagggaga agcttctctt gcctcttccg tgtcccaaca gcggcagcac 9338 accaatccca gcctctgtct tcacacagcc ttctctgtgt ctctctcctc ttcattgtct 9398 cataaggaca cttgtcattg gatttagggc ccactggatc ctccaggatg atctcatgtg 9458 gggaacctta accacatctg caaggaccct ttttccaaat aaggtcacag ccacagtttg 9518 tgggggttag gatgtgagtg tatctctttg gcagccactg ttccctcctc tcccttgggc 9578 cagaagcaga cgtggggccc tttcttcccc ataggatgcc catggattgc cccccttccc 9638 gcttcccccg agcgtctgtg ggaggtggca ggaatggcag gcaggtgtgt ggaacccctt 9698 ctggagtcat atcaagggct tggctggagg aagtcctcct ggagctgttg ggctggcatg 9758 gggcaggctg gctgggccca gcagcagctt cttcattcat ggggaggcca caagcatggg 9818 ccctagagct ggctgccgcc ctcaaaccca gaccctgcac tcttaactgt gtgaccttgc 9878 atacgtcact caccctctct gatcttcagg ttcctctgca aaagggaggt aatgataacc 9938 ctcactctgg ggggctgttt ggagggttaa atcagttatt gctgtagcat gcatttctct 9998 gtcaggtatt gagtgaggtg ctgtgatttt agccctgcat ttttcttttc ttaccattca 10058 ataataacgt tttgagcacc ctctgtgcgc caggcaccat attaggtgct ggggatacaa 10118 atgtgaatga aatgaatgtg gtctctttcc ccaacagtgt atccagaaga ttaatccatt 10178 ccttaaacaa atgctacttg acacagatta gttctggata ggctgagagc tctgaaggag 10238 tgcaggcagc tgcgagcctg tgtatccagc agaaggatca ggaaaggatt cctggaggaa 10298 gcgctgttct agccaagacc tacgggggca ttattaacca ggcaaagggg acggtgtcca 10358 agcagtggaa tgaacgtgga ttgaagctgt gaggcaggag ggagtgtggc ctgtgcagaa 10418 gggaccgagg ctggtgagac cagcagggcc tgggtggcct ccaggtcaga tgtgaaagga 10478 agaacttggc cacagtctga gcttctcagg cgtatggcag ggctgcctgg tgagagggaa 10538 tgagctccct gctctggagg tatgcaagca ggactgggct ctcacctgcc agaggccaca 10598 gagctttcca gaggctggaa gaggccactc caaggcctct ttgcccctga gagtggtggc 10658 tcttcttgag gccaccttgc cacgctgtca cagggaacta gcagcccctg cctcacccgg 10718 gggtttggaa gatagaggga ggcctaggaa gggccctgtg tctcatccga gctgggcccc 10778 tttccagcct ctcactggaa ggaagcccaa ggatgttcct gtgggggctt ttaccaggcc 10838 cacctgccct ctgctggcca tgcttgcagc ctcctgaccc tgtcccagca ggacagtggg 10898 ctggtgtgag cgggcaggaa ccgcctgcac ttagaaggtg tggggctgcc tccccgagct 10958 tccatctgcc gctggggcca caccccaggc ccagggatgg gaccccatag tggtcacatc 11018 atcttgcagc agaacccagg tacagctcct ggagcagatg gtggtcccaa gcacgggtgg 11078 gaccagaaag gactctcacc tgggctaact cagctgcagc ctcagttccc tcctcacaca 11138 cgaggaacat ggactggaag cctgcccagc aggccttctg ctcgatgtgc gttgtgtggc 11198 ttacgtccag ggagggaagc agcctctgtg ctgtcttcta gataagcctg tattccccgg 11258 gctgtctgcc aatgtatcca gttgtcccgt cagcctggaa gctctgaggg aaaaccttgg 11318 gctgcttcct gagcacctgt atcccctgca gccagcccgg ggcctctgct aggagcagac 11378 tgagcatggc ttatgggcct ggcaccatct ggcctctgcc caccttgctg gccttgtctt 11438 gtgtctgccc cttcgacatt ccatagccca gctcaatatc tagtggttcc tctagggtgg 11498 cgagcactgt ttggtctcca gatgtcttca ggtcggagct cacagcgctc tcagccaccc 11558 cttcccagtg tagcaccggg cacatggtag atgcctattg atgagtgaaa gctcctaaca 11618 cactcagaga gcaaggactc cgcctcatcc cacagcctgg gaggagaggc agactgccaa 11678 ggacctgctc agcatgctac agaagaaacc aaagtgccca cgggactgat cagtggagct 11738 tcctgccgag actggaggcc ttagggcagg gtagacagtg tgtgtgcagg ctggggactc 11798 acagttcgga ctgtgcccag acctactagc atagtgggtg ggtgggagga tgcgggactg 11858 ggggccgacc ttgcctgaaa ttcatgtggg atctcagagc agccactgaa ttgctctgta 11918 gggggctaaa tagtggcccc cacagataca cacacccaga cagagcctgt gagccagacc 11978 ttatttggag aaaaggtctt tgtagatgta attaagcatc tcaagatggc atcatctgga 12038 ttatgcggtg ggctgtaagt cctgtgatgt gtctttatga gagaaaggca gagggagatt 12098 tgacacacac aggaggggcc acgtggagac agaggtggag attggagaaa tgtggccaca 12158 agccagggaa caccagcagc caccagaagc cggaagacgt gaggcagggt tcttcccaga 12218 gccttcgctg ctgagtctgg gaatttgtta ccgaagccat aagaagtggg tacacgccct 12278 gagcctccca cacttgctca cctgtcctga gatgagaatc tctactctgc agcatatttg 12338 gaggatcact gcgggggcca cagaggtgct gttcagatgg cacttcagaa gactcaggag 12398 accctggggc aggagcagtt tgactgacag cccagagggc tgccctctga ttccacctga 12458 ggccctgctt ttcctggctg caggggttcc agggccaggc catttccgct ggcgcaggac 12518 tctgctagca gcaacctgcc tgaagtcttc ctttggcctg gctgagagtt tctgagacct 12578 gcgctggagc ggaggtgctt ccttccttgc ttcctttctt cctctctccc ttctccatcc 12638 agcaggctgg acctgcctgg catctgtgag ctctccctac tttctcctat accctaacct 12698 ttgtcctgca tgggcgactc ccccagtgag tctcttgcag cttttacccc agtgcctgct 12758 tcttggagaa tccaaactga tccagttagg gatgataaag tgtagggtag gtgctcggtg 12818 actgttttct ctgaggttgt gactcgtgtg aggcagaagc agtccccgtg agccctcctg 12878 gtatcttgtg gagtggagaa cgcttggacc tggagccagg aggcccagac atacatcctg 12938 tccgagctgc agcttcctgt ctctaaaatg agccggccag cgcaggtggc cagacatcac 12998 tgttattctc ctttgagtct ttaaatcttg ttgtctttct tgcagactcg gtgagctgtg 13058 aaaggctata ataggggctt tattttacac tttgatacta ttttttgaac attcatatta 13118 ttgttagata ttgatattca tatgaaggag caggatgact tgggtccttc ttggcagtag 13178 cattgccagc tgatggcctt ggacagttac ctgccctctc taggcctccc tttccttgtc 13238 tatgaaatac attatagaat aggatgtagt gtgtgaggat tttttggagg ttaaacgagt 13298 gaatatattt aaggcgcttt caccagtggc tgggatgtgc tctgtagttt gtgtgtgtta 13358 actataaggt tgactttatg ctcattccct cctctcccac aaatgtcgcc ttggaaa 13415 gac gga ggc agc ctg gtg gag gtg tat ctc cta gac acc agc ata cag 13463 Asp Gly Gly Ser Leu Val Glu Val Tyr Leu Leu Asp Thr Ser Ile Gln 175 180 185 190 agt gac cac cgg gaa atc gag ggc agg gtc atg gtc acc gac ttc gag 13511 Ser Asp His Arg Glu Ile Glu Gly Arg Val Met Val Thr Asp Phe Glu 195 200 205 aat gtg ccc gag gag gac ggg acc cgc ttc cac aga cag gtaagcacgg 13560 Asn Val Pro Glu Glu Asp Gly Thr Arg Phe His Arg Gln 210 215 ccgtctgatg ggagggctgc ctctgcccat atccccatcc tggaggtggg tggggactgc 13620 caccccagag cattgcagct gtactcctgg gttgcacccc cccagctgtc actgtcccct 13680 ccctgccatc agttgtggga agggcgttca tccatccagc cacctgctga tttgttatag 13740 ggtggagggg gggtctttct catgtggtcc ttgtgttcgt cgagcag gcc agc aag 13796 Ala Ser Lys 220 tgt gac agt cat ggc acc cac ctg gca ggg gtg gtc agc ggc cgg gat 13844 Cys Asp Ser His Gly Thr His Leu Ala Gly Val Val Ser Gly Arg Asp 225 230 235 gcc ggc gtg gcc aag ggt gcc agc atg cgc agc ctg cgc gtg ctc aac 13892 Ala Gly Val Ala Lys Gly Ala Ser Met Arg Ser Leu Arg Val Leu Asn 240 245 250 tgc caa ggg aag ggc acg gtt agc ggc acc ctc ata g gtaagtgatg 13939 Cys Gln Gly Lys Gly Thr Val Ser Gly Thr Leu Ile 255 260 265 gccccagacg ctggtctctc tccatctgga cctggcctgg gaggtggctt gggatgggcc 13999 cagggagagc taatgtctcc taaccaagaa tgctgtggca gcctctgccg cagagccaga 14059 gaaccagagt gccaaggctg gcagggttcc cagtggccac gagtgcagat gaagaaaccc 14119 aggccccaag agggtcatgc aggtagccca gggagttcag ccttgaccct gggtcaatga 14179 cctttccaca gttccacact gctccccttt taaaatccgg tgatgtcttt atgtcttttg 14239 ttatgttatc ttcaatgtgg agggactcga ggtgatctaa gcaaactttt tctatcttct 14299 gcttgcatac ctctgagacc aggggactca ctcacttgca tgactgggcc ctgcaggtca 14359 cactggccag gcagatgtgg tggaggaact ggcagaggac tttttctaga ctgtgactac 14419 atttagtcca cccagcggcc cccctatgaa gtccagttga gaactaggac tctgggggcc 14479 tgtggacaga gaagagggag ggttctctcc cttactgact tccttctgtg gccagacatt 14539 gagcaaggcc tctgtacagc atgtcctggg gctggccttg ccgtagctgc taaatagttg 14599 acgaaaccag tccagagagg ggaggtgact gccagggtca cacagctcaa gctggggaac 14659 tcgctgggaa aactgtcagc tctgggcagc agcttgactt ccattgtaag ccccagcccc 14719 cagggtcaaa cactggctct ggtgctggca gaggcagccc actagcctgt ttcaaaggct 14779 gagaaggccc aggagtctgc cctgtgctcc accagttctg ccctgagact ttcctacaga 14839 gtacaggttt tgatgttcag ttttaaaggc aagaatcaat aaccttctgc cccatcaggt 14899 gaccccttgt gcctgtccca cccctttatt gactgacctc ggctcagtca ggtcagttcc 14959 tgaaggtcag tgtgtggagg ggaggctgtt ctttcccaga aaggccttcc ccaggcctgg 15019 tgctctggcc tctggaggac ttcctggaga agtcccttct ttggggtccc agtcagtgta 15079 tgggaagccc ttattgcatg acctggcacg gggtaggggc tcaacagtca ctattgcctt 15139 ccttgccact gccatttcct cctctgtaag caggtgattg tgtgtccagt ctgagcacag 15199 agataagcac acagcaggtg cttaataact agcagctgta ggctgggcgc ggtggctcat 15259 gcctgtaatc ccagcacttt gggaggccga ggtgggcaga tcacctgagg tcaggagttc 15319 gagaccagcc tgttcaacat ggtgaaaccc cgtctctact aaaaatacaa aaattagcca 15379 ggcatggtgg tgggtgtctg tatcccagct acttgggagg ctaaggcagg agaatcgctt 15439 gaacccagga ggtggaggtt gcagtgagct gagatcgtgc cactgcaatc cagcctgagt 15499 gatagagcga gattccatct caaaaataaa taagtaaata actagcagct gtaaatgtgg 15559 ctgttgttct tcacctccac actcagtgcc actccactcc ctccctccgt ggtgtgaggg 15619 gcctcactag ctgtctccta ggaggagcat ggctgtgaga ttccagctcc atccttgacc 15679 acggctcctg gagacatctt agaggccagg atccagaagg ctcccacacc ccatttgaca 15739 ggggagaagc tgtcagttcc aggtcccctt gcacatcagg gccagagctg cgttaggcct 15799 ccagtctcca ggccactggg ccagagctca caggctggca gagggttaga actgttactg 15859 gtggctgggt gcactggctc acgcctgtaa tcttagcact ttgggagggc aaggcgggag 15919 gatcatgagg tcaggacatc gagaccatcc ttgctaacac ggtgaagccc cgtctctact 15979 aaaactacaa aaaattagcc gggcgtggtg gcaggcgcct gtagtcccag ctactcagga 16039 ggctgaggca ggagaatggc gtgaacccgg gaggcggagc ttgcagtgag ccgagattgc 16099 gccactgcac tccagcctgg gcaatagagc gagactccgt ctggaaagaa aaaaaaaaaa 16159 agagctgtta ctgttgacag tagcatgagg tagaccatgg cctgcaccaa aagggggagt 16219 ggagtgccac tgaggccaga aggaaccaca ccctcaaggg tggggagtta tggtatgggg 16279 ggtcctaggc atggagtctt ttaattcttt agacaatcct gggagcagct gtccctgttt 16339 cacagagggc ggggccacac agctggtgag tgggcagcca agactctgtt caagtttgtg 16399 tgggtccaac acttgcggcc acggtggagg ggcatctgag ccaggcctca gagagtggcg 16459 gggggaagtt gggtggggaa gtgtgccctt ctcattcctc tgaggctcat cctcttggtg 16519 cctctctttc atggaaaggg ataataaggt tattgtgagg atcccctgag ttcatatatt 16579 cagacgctta gacagagcca ggcacagaga agggcccggg gttggctagt ttgattgctg 16639 gtgtaattgc taatatcttc cagtttgtat tggtcaaggt tctgcagaga agcagaacca 16699 gtaggaggta tatattaaga gtttcaagct catgtgaccg tgcgggctgg caagtctgaa 16759 atccgcaggg caggccatgc aggctggcaa ttcctgcaga atttgatgtt gcaatactga 16819 gtcctaaggc agtcctgggg cagaattcct tcttccctgg gaggcctcag tctgttctct 16879 taaggccttc aactgattaa atgaggcctg cccaagttat agagagtaac ctgccttact 16939 ccgtcttctg atttaaatgt tagtcacatc taaaaaatat tttcgcagca gcatttccac 16999 tggcttttga ccaaacatca ggccacaaag ttgatcccca aaattaacca tcactctgtg 17059 cctgtaaggg aggggctggg aaaggggagc aggtctcccc aaggggtgac cttggctttg 17119 ttcctcccag gc ctg gag ttt att cgg aaa agc cag ctg gtc cag cct 17167 Gly Leu Glu Phe Ile Arg Lys Ser Gln Leu Val Gln Pro 270 275 gtg ggg cca ctg gtg gtg ctg ctg ccc ctg gcg ggt ggg tac agc cgc 17215 Val Gly Pro Leu Val Val Leu Leu Pro Leu Ala Gly Gly Tyr Ser Arg 280 285 290 295 gtc ctc aac gcc gcc tgc cag cgc ctg gcg agg gct ggg gtc gtg ctg 17263 Val Leu Asn Ala Ala Cys Gln Arg Leu Ala Arg Ala Gly Val Val Leu 300 305 310 gtc acc gct gcc ggc aac ttc cgg gac gat gcc tgc ctc tac tcc cca 17311 Val Thr Ala Ala Gly Asn Phe Arg Asp Asp Ala Cys Leu Tyr Ser Pro 315 320 325 gcc tca gct ccc gag gtaggtgctg gggctgctgc cccaaggcgc gggtaggggg 17366 Ala Ser Ala Pro Glu 330 cggagggcgg agggagggcg ggcgggcagg cgggcttctt gtggcacgtg ggcttcttgt 17426 ggcacgttcc tggaggccga acccttctgg ctttggaagg agtcgtcaga gacccccgcc 17486 atgcgggagg ctggggagga aggggctcga aacctccatc atcgcagagt ctgaatagca 17546 gtggccccgc catgcgccca cgtagcggcg cctacgtagc cacgccccca cgccccgtcc 17606 tggccactct ccctcctgaa ggtcttctgg tacccgcccc ctccccatct ccatccccag 17666 gccctgcgtc ctctgcccaa tactctttgg gcctccctgt tgtccagctc tctccgcggc 17726 tccatgactg acaacttgag caaggctaat gtgaatggga gcggttgagg gctcagacct 17786 ctcacccgag gaacatccac agagtgtgcc gcatgcccgg tgcagtgtgg ctgcggggac 17846 acagacacgg agcctcggcc ctgaggagct ggggggcagt gaccgtccct cctctgaccc 17906 accactcctc cagtgtcagg acactgcggg tatctagggg aaggaatctt gttccacttc 17966 aagtctggaa cttcaagtct gtgtgtgtgc gtgcgcgcgc gcgcgttggg ggtgggggtt 18026 gcagagcaga tgcgtacctg acagcggtaa cctaggtccc cccggcctat caaggcttcc 18086 ctggcggccg aatttaaagg catcaagcaa acaaagccca acacatctct gccttgtcct 18146 ctcagtttcc ccccgtggca cttagaacca cttgatacac cgaatagttt ccggtctatc 18206 tcccccacta ggatgtaaac tccacagggg cattgggaat gctgcctggc tatggtaggg 18266 acagagggga gcaccagggc ggggcagggg tgccagagtt ctgcctgggc agtcagattt 18326 tccttaggag gggacatttg agtgggaccc aaacaggtgt atagcagttg tccagcccag 18386 ctggcaaggc ctgagtctgc ctctgcaacc cctctcttgg gctcctttct ctgccaccca 18446 cctcctcacc tttccag gtc atc aca gtt ggg gcc acc aat gcc cag gac 18496 Val Ile Thr Val Gly Ala Thr Asn Ala Gln Asp 335 340 cag ccg gtg acc ctg ggg act ttg ggg acc aac ttt ggc cgc tgt gtg 18544 Gln Pro Val Thr Leu Gly Thr Leu Gly Thr Asn Phe Gly Arg Cys Val 345 350 355 gac ctc ttt gcc cca ggg gag gac atc att ggt gcc tcc agc gac tgc 18592 Asp Leu Phe Ala Pro Gly Glu Asp Ile Ile Gly Ala Ser Ser Asp Cys 360 365 370 375 agc acc tgc ttt gtg tca cag agt ggg aca tca cag gct gct gcc cac 18640 Ser Thr Cys Phe Val Ser Gln Ser Gly Thr Ser Gln Ala Ala Ala His 380 385 390 gtg gct g gtaagtcacc accccactgc ctcggccacc gtgatgctaa cagccccttt 18697 Val Ala ggcagtcagg gtctgtgccg ggacctccag tgccaggctc tgtgcagggg gaccagagat 18757 gaagtaggcc tgatggtgcc ttcaaggaca ctcagtctga tgagggaggc gagtgcacag 18817 agggaacacg aggtcagggc tgtattagag ggagcccaga ggaggcacct gcccagcccg 18877 agggtcagag aaggcatctt ggaggaggga catttgatcg ggagcttgat ggatgaatag 18937 gagtttacct ggccgataag acagcaacta ccaaggctta gaggtgtgag aggaggctgt 18997 cttacctcac tgagtaagga ctgcaggcgg cttaccttcg agaagagagc ttagtgtctg 19057 tgtgcacgtg tgtttgtgtg tatgtgtgtg cgtgtgtgca ctggcaggag tcccctgctg 19117 gggcaggagg gccgggccat caccatcttt caccattcac ccctgcacca ggc att 19173 Gly Ile 395 gca gcc atg atg ctg tct gcc gag ccg gag ctc acc ctg gcc gag ttg 19221 Ala Ala Met Met Leu Ser Ala Glu Pro Glu Leu Thr Leu Ala Glu Leu 400 405 410 agg cag aga ctg atc cac ttc tct gcc aaa gat gtc atc aat gag gcc 19269 Arg Gln Arg Leu Ile His Phe Ser Ala Lys Asp Val Ile Asn Glu Ala 415 420 425 tgg ttc cct gag gac cag cgg gta ctg acc ccc aac ctg gtg gcc gcc 19317 Trp Phe Pro Glu Asp Gln Arg Val Leu Thr Pro Asn Leu Val Ala Ala 430 435 440 ctg ccc ccc agc acc cat ggg gca g gtaagcagga tggcagggtg 19362 Leu Pro Pro Ser Thr His Gly Ala 445 450 ggcaagtcca ggctggggct tgggaggtct gtgtgacctt gacagtctct cccttctccc 19422 ttgtctgtgt aaggaggatg atgccacctt aaataggatt aaatgagaat ggggctctga 19482 aagggctgtg caatattttc ataacgtgtt tttatagaga cagttgagta tgttctttaa 19542 gccctcctct ctcctaccat gaactaaaga tttttgtgga ggtcccctca ctcccagcac 19602 cccctcctca tcccaggccc tttttgca ggt tgg cag ctg ttt tgc agg act 19654 Gly Trp Gln Leu Phe Cys Arg Thr 455 gtg tgg tca gca cac tcg ggg cct aca cgg atg gcc aca gcc atc gcc 19702 Val Trp Ser Ala His Ser Gly Pro Thr Arg Met Ala Thr Ala Ile Ala 460 465 470 475 cgc tgc gcc cca gat gag gag ctg ctg agc tgc tcc agt ttc tcc agg 19750 Arg Cys Ala Pro Asp Glu Glu Leu Leu Ser Cys Ser Ser Phe Ser Arg 480 485 490 agt ggg aag cgg cgg ggc gag cgc atg gag gtgactgtac ccctccttcg 19800 Ser Gly Lys Arg Arg Gly Glu Arg Met Glu 495 500 tgtgtgtgtg tgtgtgtgtg tgtgtgtgtg tgcgtgtcag tgctgggccc tcagggaccc 19860 ccagcaagcc cctccatcct ccagactcca gctcttctgt aagcttacag ggctggccag 19920 accaggagtg gggcactcct cacttcacgc ggctgggggc tgctggagag agccacagcg 19980 ggaagggttt cctagaggct gcaggacagt gctggatgga ttttcaatgc tcacctgggt 20040 gtgagcatgc ggcagggccg cgtgagggtc agcgatctgc tactctggac tcagccatct 20100 ctaggcccct ctcactcagg tgctccatgg ttctgggagc tgagaaatct caaaccagca 20160 aaaaagtgga attgatgttg atgctacagg atagtgcaca gatgccatct ggttgcagca 20220 ttttggtgga agggcagtgc ccagctagga gagtgaggag gggcaggcat ttctggcttg 20280 aggagatagg gtcttaatgc tcgtgtgaga ggcagagtgg gtggagtgga gctggctgga 20340 tccttgcttt ggcctcctgg atttctctct atctccattt tgaaaccact ctgtgtttgg 20400 aagaactttt gagtattcag agctgcccac tggcagaaca gtcttccttg ggcaggagtg 20460 agctccttgt ccccagaagg ctgggtctgg ctggcccctg gcagggacac tgatgagggt 20520 gcttgagttg atcctgtcta gtccctttct gtgttttcaa agcccattct aaagcagatt 20580 cccatttccg tctttgactc taag gcc caa ggg ggc aag ctg gtc tgc cgg 20631 Ala Gln Gly Gly Lys Leu Val Cys Arg 505 510 gcc cac aac gct ttt ggg ggt gag ggt gtc tac gcc att gcc agg tgc 20679 Ala His Asn Ala Phe Gly Gly Glu Gly Val Tyr Ala Ile Ala Arg Cys 515 520 525 tgc ctg cta ccc cag gcc aac tgc agc gtc cac aca gct cca cca gct 20727 Cys Leu Leu Pro Gln Ala Asn Cys Ser Val His Thr Ala Pro Pro Ala 530 535 540 gag gcc agc atg ggg acc cgt gtc cac tgc cac caa cag ggc cac gtc 20775 Glu Ala Ser Met Gly Thr Arg Val His Cys His Gln Gln Gly His Val 545 550 555 ctc aca g gtaggaggct gggcttgccc tggggtgagg aggggtctct ttctccttat 20832 Leu Thr 560 gcacccactg cccacgaggc ttggtcctca caagtgtgat ccatgagact caagcctgac 20892 ttgcagttcc atactctggt tctgccactt ccatgccctt tgagcctggg caggtgacct 20952 tacttctcct catctcagct tcctcctcca taagagggaa aaaggtatta cctgcctcat 21012 tgtgttgcaa ggagatgggc agcatctagg gcactggcct ggagtatcgc aggtgctttg 21072 cctaaggtgg tgcagtccag gagaggcagc tccagagaga ggcccccggc tggggctgaa 21132 aggagggcag acctcggttt gaatttcacc ctgccgctcg atagctgtgt gacttgggca 21192 aattacttaa catctctgta tgaggaaatg atgagtgcta agcacttagc ttagtgccgg 21252 gacaatataa attctagcta tcgttactat tgttttcatc acccgttgct ttaaaatcca 21312 gtctctggta taggcaacta ttgacgggct accctgtgtc gaaaacatgc ccaggcaggt 21372 agcaggaagt cacagatggg gacctcttgg ggcatcaagg gatggtgccc tgaggctgag 21432 ctgttctggt tgggtggagc atgagaggtc tgggaagaca gtgggactcc agcctggaat 21492 aagaggctca gagttgattc tcgtctgagc acgtccaggg gaaccactga gggtttggga 21552 acaggagagt gagggtgaga acctggttct gggcacagca ggctggcatg taggatggat 21612 gttcaggaaa gatgagcata gtcaggtggc tggtgccctt gtccagggga gaggctccgt 21672 caggttcagg ggtcctggct tggagggaag tccgccatgc tctaatcacg ctcccctttg 21732 gaagtgctcg gccgatgagc tcacaggcac atgtcagttt gaagtcatgg aatctgactc 21792 catgaagcgc acctcaaaga gcaccatttt gcagctaagg gaactgcagg ctggacatgc 21852 tgagtggctg ccccgagccc ttgcagctag gacatagaga atgctagtaa ccacaaccct 21912 accatgttca gagcacatgc caggctccat gctggggctt cgcacgtgtc atcttcacag 21972 tgtccctgtg agtaggtgtg gtttctcttt ccatcttaca aatgagtaaa cagagcctca 22032 gtgtagctaa gtaaccacta ttttaggttt cttagccaat gggtgtgtct gactcctaag 22092 cccatggagg gcattctgag gtggttcaga cagaccccag cttacccttg aacttctgcc 22152 tgctggctgc atagggaggg gctgggggga gtttgagcat ctcaggccat agagcccctg 22212 cctcactgtc tccatctctg ggtggaaaga tggtgttttc cctgagaaac taaggctcag 22272 agaggttgaa tggctctccc aaggtcacac agctggtcag ctgcagagtt gagaacacag 22332 gagtcctggt gctcaggcca gcatctcttt ttttctttga gttgtttcta ggtttcctag 22392 ctcttgcctc agaccttaaa gagagagggt ctgatgggga tgggcactgg agacggagca 22452 tcccagcatt tcacatctga gctggctttc ctctgcccca ggc tgc agc tcc cac 22507 Gly Cys Ser Ser His 565 tgg gag gtg gag gac ctt ggc acc cac aag ccg cct gtg ctg agg cca 22555 Trp Glu Val Glu Asp Leu Gly Thr His Lys Pro Pro Val Leu Arg Pro 570 575 580 cga ggt cag ccc aac cag tgc gtg ggc cac agg gag gcc agc atc cac 22603 Arg Gly Gln Pro Asn Gln Cys Val Gly His Arg Glu Ala Ser Ile His 585 590 595 gct tcc tgc tgc cat gcc cca ggt ctg gaa tgc aaa gtc aag gag cat 22651 Ala Ser Cys Cys His Ala Pro Gly Leu Glu Cys Lys Val Lys Glu His 600 605 610 gga atc ccg gcc cct cag gag cag gtgaagaggc ccgtgaggcc gggtgggtgg 22705 Gly Ile Pro Ala Pro Gln Glu Gln 615 620 ggtgctgcgt gtctctcctg cacagctttt ctgtgtcagt ttgtgccacc accataccgc 22765 catacatcag ggtggcggtt tgccaggtag atgctgtggg cagcttccgc cattgtgtgg 22825 acagcatgta tatgtgtctc tgtgtggctg ggtctgtttt tgcttttgtc cagatcagta 22885 aggtttgcta cctgggtacc ccactccact tggagtagag tgtgcataaa tatggcataa 22945 agaaatgcaa tatgcatgca tttattgatt gatctatttt tttctgagat ggggtcttgc 23005 tgtgttgccc aggctggtct caaattcctg ggctcaagca atcctctggt ctcagcctcc 23065 ccaagtgttg ggattatagg catgagccgc tgcacctggc ctctctgatc tatttaacaa 23125 acctgctggg agggtctcag ggtcaggagc agcactgggc tctgaggaca cagagctcac 23185 tcagccgtga cccagagggg gtgcctgagc tgcatgctga aggttgttag catgaccagc 23245 aaggcaagaa aaggccctgc cgagattagc aaggcatgtg ccaagccctg gaatgtgaca 23305 gccgggcctt ctagaaacct gagtgtataa ctctccttaa aagccagtag gagctcctta 23365 aaaggcagcc ctaaggagtc cactcttaaa tgaactcaga gtcagtttta aaatgcaagt 23425 ctgtgttgat tctggtctgg atggtgcatt cctcgagagc aaaagacagt cttggtcttg 23485 gatccacttg ccctgggtac actgagggct gctaggttcc aggtgctctt cctggcactg 23545 gggagggata caggcccaag agacatgctg ttctccctcc tggagcatct attttagtgg 23605 aggaagacag aaaacaaacc attaatatag agtactgaaa agatgcgatg gagaaaacta 23665 tagcaaggaa gggaatgggg tgggagagag gtcaggagag gtctcgctga caaggtggac 23725 gaaacaggcc atgaggcaga gaacatgttc caggcaaagc aaaggccccc aggtggggat 23785 gtgcagggag taccaggaaa ccagagaggt gggaatagtt atgagatggg gggtgcctca 23845 gaggggacag ggccaagtca ggtgagacct gagggccaca gtcagcagtg agctggggcc 23905 atgcaggggt ctggcctcag aggagtgtgg tctggcctgg atctgaacct ctcactgtgg 23965 cctagctgct gagctgagaa gagatgacaa ggaccttggg cagaagcagg gagactggag 24025 ggaggcggtg gagggtccag gcgttggggc ggggctcagg ctggagtctg aagggagcct 24085 gcaggcctgg tgggtggatg tgggtgggag agggggagga tggcaccaag gctcgggccc 24145 ctggacagat ggagttgcca ttaagtggga tggggcaggc tatggggcca tcagtttcag 24205 agggatgagt ttggcactgg catggtaggc atctgtctat ctccacggcc ctcaaaccag 24265 gcatgaagca ggagctcacg tgtttggtca gccatggtgc agaaccgcct gggtgggagg 24325 tgcggggtgg gagatacacg gttgtgtccc aaatgggctc tgagccagcg agggccgtct 24385 gcactttggc ctcacagaag gatgtcggag ggagaaatga agtgtgggtg ggggtcccgg 24445 gccacgctag acatgtgctt tcttttcctc gggctctggc ag gtg acc gtg gcc 24499 Val Thr Val Ala 625 tgc gag gag ggc tgg acc ctg act ggc tgc agt gcc ctc cct ggg acc 24547 Cys Glu Glu Gly Trp Thr Leu Thr Gly Cys Ser Ala Leu Pro Gly Thr 630 635 640 tcc cac gtc ctg ggg gcc tac gcc gta gac aac acg tgt gta gtc agg 24595 Ser His Val Leu Gly Ala Tyr Ala Val Asp Asn Thr Cys Val Val Arg 645 650 655 agc cgg gac gtc agc act aca ggc agc acc agc gaa gag gcc gtg aca 24643 Ser Arg Asp Val Ser Thr Thr Gly Ser Thr Ser Glu Glu Ala Val Thr 660 665 670 gcc gtt gcc atc tgc tgc cgg agc cgg cac ctg gcg cag gcc tcc cag 24691 Ala Val Ala Ile Cys Cys Arg Ser Arg His Leu Ala Gln Ala Ser Gln 675 680 685 gag ctc cag tga cagccccatc ccaggatggg tgtctgggga gggtcaaggg 24743 Glu Leu Gln 690 ctggggctga gctttaaaat ggttccgact tgtccctctc tcagccctcc atggcctggc 24803 acgaggggat ggggatgctt ccgcctttcc ggggctgctg gcctggccct tgagtggggc 24863 agcctccttg cctggaactc actcactctg ggtgcctcct ccccaggtgg aggtgccagg 24923 aagctccctc cctcactgtg gggcatttca ccattcaaac aggtcgagct gtgctcgggt 24983 gctgccagct gctcccaatg tgccgatgtc cgtgggcaga atgactttta ttgagctctt 25043 gttccgtgcc aggcattcaa tcctcaggtc tccaccaagg aggcaggatt cttcccatgg 25103 ataggggagg gggcggtagg ggctgcaggg acaaacatcg ttggggggtg agtgtgaaag 25163 gtgctgatgg ccctcatctc cagctaactg tggagaagcc cctgggggct ccctgattaa 25223 tggaggctta gctttctgga tggcatctag ccagaggctg gagacaggtg tgcccctggt 25283 ggtcacaggc tgtgccttgg tttcctgagc cacctttact ctgctctatg ccaggctgtg 25343 ctagcaacac ccaaaggtgg cctgcgggga gccatcacct aggactgact cggcagtgtg 25403 cagtggtgca tgcactgtct cagccaaccc gctccactac ccggcagggt acacattcgc 25463 acccctactt cacagaggaa gaaacctgga accagagggg gcgtgcctgc caagctcaca 25523 cagcaggaac tgagccagaa acgcagattg ggctggctct gaagccaagc ctcttcttac 25583 ttcacccggc tgggctcctc atttttacgg gtaacagtga ggctgggaag gggaacacag 25643 accaggaagc tcggtgagtg atggcagaac gatgcctgca ggcatggaac tttttccgtt 25703 atcacccagg cctgattcac tggcctggcg gagatgcttc taaggcatgg tcgggggaga 25763 gggccaacaa ctgtccctcc ttgagcacca gccccaccca agcaagcaga catttatctt 25823 ttgggtctgt cctctctgtt gcctttttac agccaacttt tctagacctg ttttgctttt 25883 gtaacttgaa gatatttatt ctgggttttg tagcattttt attaatatgg tgacttttta 25943 aaataaaaac aaacaaacgt tgtcctaact cttgcataga cttgactgcc tagggtgatg 26003 ccttgcttat actaggaact gggtaagttt gttgaatagt tgagtaagcc aagtatttga 26063 tgagtacttg tatcttgagt acaagtattg ggcaagtact ggtgatgtga acttactcct 26123 tgtgcctatc ctaggaatga aatgaatgtc ttcctgcagc tcccctgacc accctgacag 26183 tcaaagtgcc tcctccttgg tgacaggtgc cctacag 26220

1a

RELATED APPLICATION [0001] This application is a continuation-in-part application of Ser. No. 09/584,555, filed May 31, 2000. FIELD OF THE INVENTION [0002] This invention relates to methods of reducing the damaging effect of an injury to mammalian cells by treatment with compounds which reduce the binding between N-methyl-D-aspartate receptors and neuronal proteins; pharmaceutical compositions comprising said compounds and methods for the preparation of said pharmaceutical compositions. BACKGROUND TO THE INVENTION [0003] Ischemic or traumatic injuries to the brain or spinal cord often produce irreversible damage to central nervous system (CNS) neurons and to their processes. These injuries are major problems to society as they occur frequently, the damage is often severe, and at present there are still no effective pharmacological treatments for acute CNS injuries. Clinically, ischemic cerebral stroke or spinal cord injuries manifest themselves as acute deteriorations in neurological capacity ranging from small focal defects, to catastrophic global dysfunction, to death. It is currently felt that the final magnitude of the deficit is dictated by the nature and extent of the primary physical insult, and by a time-dependent sequence of evolving secondary phenomena which cause further neuronal death. Thus, there exists a theoretical time-window, of uncertain duration, in which a timely intervention might interrupt the events causing delayed neurotoxicity. However, little is known about the cellular mechanisms triggering and maintaining the processes of ischemic or traumatic neuronal death, making it difficult to devise practical preventative strategies. Consequently, there are currently no clinically useful pharmacological treatments for cerebral stroke or spinal cord injury. [0004] In vivo, a local reduction in CNS tissue perfusion mediates neuronal death in both hypoxic and traumatic CNS injuries. Local hypoperfusion is usually caused by a physical disruption of the local vasculature, vessel thrombosis, vasospasm, or luminal occlusion by an embolic mass. Regardless of its etiology, the resulting ischemia is believed to damage susceptible neurons by impacting adversely on a variety of cellular homeostatic mechanisms. Although the nature of the exact disturbances is poorly understood, a feature common to many experimental models of neuronal injury is a rise in free intracellular calcium concentration ([Ca 2+ ]i). Neurons possess multiple mechanisms to confine [Ca 2+ ] i to the low levels, about 100 nM necessary for the physiological function. It is widely believed that a prolonged rise in [Ca 2+ ] i deregulates tightly-controlled Ca 2+ -dependent processes, causing them to yield excessive reaction products, to activate normally quiescent enzymatic pathways, or to inactivate regulatory cytoprotective mechanisms. This, in-turn, results in the creation of experimentally observable measures of cell destruction, such as lipolysis, proteolysis, cytoskeletal breakdown, pH alterations and free radical formation. [0005] The classical approach to preventing Ca 2+ neurotoxicity has been through pharmacological blockade of Ca 2+ entry through Ca 2+ channels and/or of excitatory amino acid (EAA)-gated channels. Variations on this strategy often lessen EAA-induced or anoxic cell death in vitro, lending credence to the Ca 2+ -neurotoxicity hypothesis. However, a variety of Ca 2+ channel- and EAA-antagonists fail to protect against neuronal injury in vivo, particularly in experimental Spinal Cord Injury (SCI), head injury and global cerebral ischemia. It is unknown whether this is due to insufficient drug concentrations, inappropriate Ca 2+ influx blockade, or to a contribution from non-Ca 2+ dependent neurotoxic processes. It is likely that Ca 2+ neurotoxicity is triggered through different pathways in different CNS neuron types. Hence, successful Ca 2+ -blockade would require a polypharmaceutical approach. [0006] As a result of investigations, I have discovered methods of reducing the damaging effect of an injury to mammalian cells by treatment with compounds to reduce the binding between N-methyl-D-aspartate (NMDA) receptors and neuronal proteins. PUBLICATIONS [0000] 1. A. Ghosh, M. E. Greenberg, Science 268, 239 (1995); T. V. Bliss, G. L. Collingridge, Nature 361, 31 (1993). 2. J. W. 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SUMMARY OF THE INVENTION [0046] I have found that postsynaptic density-95 protein (PSD-95) couples neuronal N-methyl-D-aspartate receptors (NMDARs) to pathways mediating excitotoxicity and ischemic brain damage. This coupling was disrupted by transducing neurons with peptides that bind to modular domains on either side of the PSD-95/NMDAR interaction complex. This treatment attenuated downstream NMDAR signaling without blocking NMDAR activity, protected cultured cortical neurons from excitotoxic insults and dramatically reduced cerebral infarction volume in rats subjected to transient focal cerebral ischemia. The treatment was effective when applied either before, or one hour after, the onset of excitotoxicity in vitro and cerebral ischemia in vivo. This approach may prevent negative consequences associated with blocking NMDAR activity and constitute a practical therapy for stroke. [0047] It is an object of the present invention to provide in its broadest aspect a method of reducing the damaging effect of an injury to mammalian cells. [0048] In a preferred object, the invention provides pharmaceutical compositions for use in treating mammals to reduce the damaging effect of an injury to mammalian tissue. [0049] The present invention is based on the discovery of a neuroprotective effect against excitotoxic and ischemic injury by inhibiting the binding between N-methyl-D-aspartate (NMDA) receptors and neuronal proteins in a neuron. [0050] Accordingly, in one aspect the invention provides a method of inhibiting the binding between N-methyl-D-aspartate receptors and neuronal proteins in a neuron said method comprising administering to said neuron an effective inhibiting amount of a peptide replacement agent for the NMDA receptor interaction domain to effect said inhibition of the interaction with the neuronal protein. [0051] In a further aspect, the invention provides a method of inhibiting the binding between N-methyl-D-aspartate receptors and neuronal proteins in a neuron said method comprising administering to said neuron an effective inhibiting amount of a peptide replacement agent for the neuronal protein interaction domain to effect said inhibition of the interaction with the NMDA receptor. [0052] In a further aspect, the invention provides a method of reducing the damaging effect of ischemia or traumatic injury to the brain or spinal cord in a mammal, said method comprising treating said mammal with a non-toxic, damage-reducing, effective amount of a peptide replacement agent for the NMDA receptor or neuronal protein interaction domains that inhibit the NMDA receptor neuronal protein interaction. [0053] Damage to neurons in this specification is meant anoxia, ischemia, excitotoxicity, lack of neurotrophic support, disconnection, and mechanical injury. [0054] The NMDA agent is, preferably, bindable with proteins containing PDZ domains, and most preferably, is selected from postsynaptic density-95 proteins, PSD-95, PSD-93 and SAP102. [0055] I have found that the replacement agent is a tSXV-containing peptide, preferably KLSSIESDV (SEQ. ID NO: 1). [0056] The neuronal protein agent is, preferably, bindable with excitatory amino acid receptors, and most preferably, is selected from NMDA receptor subunits NR1 and NR2. [0057] I have found that the replacement agent is a PDZ2-domain containing polypeptide, preferably corresponding to residues 65-248 of PSD-95, encoding the first and second PDZ domains (PDZ1-2) of PSD-95. [0058] In a yet further aspect the invention provides a pharmaceutical composition comprising a peptide replacement agent for the NMDA receptor or neuronal protein interaction domains that inhibit the NMDA receptor neuronal protein interaction in a mixture with a pharmaceutically acceptable carrier when used for reducing the damaging effect of an ischemic or traumatic injury to the brain or spinal chord of a mammal; preferably further comprising the cell-membrane transduction domain of the human immunodeficiency virus type 1 (HIV-1) Tat protein (YGRKKRRQRRR (SEQ ID No: 2); Tat), or the antennapedia internalisation peptide. [0059] In a most preferred aspect, the invention provides a pharmaceutical composition comprising the peptide KLSSIESDV (SEQ ID NO: 1) or residues 65-248 of PSD-95, encoding the first and second PDZ domains (PDZ1-2) of PSD-95. [0060] In a further aspect, the invention provides a method of inhibiting the binding between NMDA receptors and neuronal proteins in a neuron, said method comprising administering to said neuron an effective inhibiting amount of an antisense DNA to prevent expression of said neuronal proteins to effect inhibition of said binding. Preferably, this aspect provides a method wherein said antisense DNA reduces the expression of a protein containing PDZ domains bindable to said NMDA receptor. More preferably, the protein containing PDZ domains is selected from PSD-95, PSD-93 and SAP102. [0061] In the mammalian nervous system, the efficiency by which N-methyl-D-aspartate receptor (NMDAR) activity triggers intracellular signaling pathways governs neuronal plasticity, development, senescence and disease. I have studied excitotoxic NMDAR signaling by suppressing the expression of the NMDAR scaffolding protein PSD-95. In cultured cortical neurons, this selectively attenuated NMDAR excitotoxicity, but not excitotoxicity by other glutamate or Ca 2+ channels. NMDAR function was unaffected, as receptor expression, while NMDA-currents and 45 Ca loading via NMDARs were unchanged. Suppressing PSD-95 selectively blocked Ca 2+ -activated nitric oxide production by NMDARs, but not by other pathways, without affecting neuronal nitric oxide synthase (nNOS) expression or function. Thus, PSD-95 is required for the efficient coupling of NMDAR activity to nitric oxide toxicity and imparts specificity to excitotoxic Ca 2+ signaling. [0062] It is known that calcium influx through NMDARs plays key roles in mediating synaptic transmission, neuronal development, and plasticity (1). In excess, Ca influx triggers excitotoxicity (2), a process that damages neurons in neurological disorders that include stroke, epilepsy, and chronic neurodegenerative conditions (3). Rapid Ca 2+ -dependent neurotoxicity is triggered most efficiently when Ca 2+ influx occurs through NMDARs, and cannot be reproduced by loading neurons with equivalent quantities of Ca 2+ through non-NMDARs or voltage-sensitive Ca 2+ channels (VSCCs) (4). This observation suggests that Ca 2+ influx through NMDAR channels is functionally coupled to neurotoxic signaling pathways. [0063] Without being bound by theory, I believe that lethal Ca 2+ signaling by NMDARs is determined by the molecules with which they physically interact. The NR2 NMDAR subunits, through their intracellular C-terminal domains, bind to PSD-95/SAP90 (5), chapsyn-110/PSD-93, and other members of the membrane-associated guanylate kinase (MAGUK) family (6). NMDAR-bound MAGUKs are generally distinct from those associated with non-NMDARs (7). I have found that the preferential activation of neurotoxic Ca 2+ signals by NMDARs is determined by the distinctiveness of NMDAR-bound MAGUKs, or of the intracellular proteins that they bind. PSD-95 is a submembrane scaffolding molecule that binds and clusters NMDARs preferentially and, through additional protein-protein interactions, may link them to intracellular signaling molecules (8). Perturbing PSD-95 would impact on neurotoxic Ca 2+ signaling through NMDARs. [0064] Thus, protein-protein interactions govern the signals involved in cell growth, differentiation, and intercellular communication through dynamic associations between modular protein domains and their cognate binding partners (20). At excitatory synapses of central neurons, ionotropic glutamate receptors are organized into multi-protein signaling complexes within the post-synaptic density (PSD) (21). A prominent organizing protein within the PSD is PSD-95, a member of the membrane-associated guanylate kinase (MAGUK) family. PSD-95 contains multiple domains that couple transmembrane proteins such as the N-methyl-D-aspartate subtype of glutamate receptors (NMDAR) to a variety of intracellular signaling enzymes (21,22). Through its second PDZ domain (PDZ2), PSD-95 binds both the NMDAR 2B subunit (NR2B) and neuronal nitric oxide synthase (nNOS) (22). This interaction couples NMDAR activity to the production of nitric oxide (NO), a signaling molecule that mediates NMDAR-dependent excitotoxicity (23). Research has shown that NMDAR function is unaffected by genetically disrupting PSD-95 in vivo (24) or by suppressing its expression in vitro (25). Nonetheless, PSD-95 deletion dissociates NMDAR activity from NO production and suppresses NMDAR-dependent excitotoxicity. [0065] Although NMDARs play an important neurotoxic role in hypoxic/ischemic brain injury (26), blocking NMDAR function may be deleterious in animals and humans (27-29). Targeting PSD-95 protein therefore represents an alternative therapeutic approach for diseases that involve excitotoxicity that may circumvent the negative consequences of blocking NMDAR function. However, mutation or suppression of PSD-95 is impractical as a therapy for brain injury and cannot be applied after an injury has occurred. Therefore, rather than alter PSD-95 expression, I questioned whether interfering with the NMDAR/PSD-95 interaction could suppress excitotoxicity in vitro and ischemic brain damage in vivo. BRIEF DESCRIPTION OF THE DRAWINGS [0066] In order that the invention may be better understood preferred embodiments will now be described by way of example only with reference to the accompanying drawings wherein: [0067] FIG. 1 a is an immunoblot; [0068] FIG. 1 b is a bar chart providing densitometric analysis of PSD-95 expression; [0069] FIG. 1 c represents representative phase contrast and propidium fluorescence images; [0070] FIG. 1 d is a bar chart of NMDA concentration against fraction of dead cells; [0071] FIG. 1 e is a bar chart of NMDA concentration against Calcium accumulation. [0072] FIG. 2 a 1 - b 2 represent bar charts of selective activations of AMPA/Kainate receptors with Kainate ( 2 a 1 and 2 - a 2 ); and loadings with Vscc's ( 2 - b 1 ) and calcium loading ( 2 - b 2 ). [0073] FIG. 3 a - d represent immunoblots ( 3 a ); NMDA dose-response curves ( 3 b ); NMDA current density measurements ( 3 c ); and current/time graph ( 3 d ) dialyzed with hucifer yellow; [0074] FIG. 4 bar charts ( 4 a ; 4 c - 4 - f ) and immunoblot 4 b of effect on nNOS expression in cultures are hereinafter better described and explained; [0075] FIG. 5 . (A) Shows the hypothesis: The NMDAR/PSD-95 complex may be dissociated by peptides encoding either to the C-terminus of NR2 or the second PDZ domains of PSD-95 (B) Fluorescence of cultures treated with Tat-38-48-dansyl and Tat-NR2B9c dansyl. (C) Time course fluorescence after Tat-NR2B9c-dansyl application (D) Effect of peptides on co-immunoprecipitation of PSD-95 with NR2B [0076] FIG. 6 . Effect of Tat-NR2B9c on (A-C) electrophysiological function of neurons (D) NMDA-evoked 45 Ca 2+ uptake in cortical cultures. (E) NMDA-evoked cGMP production in cortical cultures. (F) NMDA-evoked excitotoxicity in cortical cultures. [0077] FIG. 7 . (A) Detection of Tat-NR2B9c-dansyl in the mouse brain 1 h after intraperitoneal injection (B) Composite neurological scores (see text) during and 24 h after MCAo. (C) Effect of Pre-treatment with Tat-NR2B9c on (i) total infarct area and volume (inset), and (ii) cortical infarct area and volume (inset) after transient MCAo. [0078] FIG. 8 . (A) Neuroprotective effects of post-treatment in cultured cortical neurons post-treated with Tat-NR2B9c or pTat-PDZ1-2 (B) Composite neurological scores (see text) during and 24 h after MCAo. (C) Effect of post-treatment with Tat-NR2B9c on (i) total infarct area and volume (inset), and (ii) cortical infarct area and volume (inset) after transient MCAo. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Methods [0079] Cultured cortical neurons were prepared by standard techniques (4, 9) and switched to serum-free media at 24 h [Neurobasal with B27 supplement (Gibco)]. The AS ODN corresponded to nucleotides 435-449 of mouse PSD-95/SAP90 mRNA (GeneBank Acc. No. D50621). Filter-sterilized phosphodiester AS SE, and MS ODNs (5 μM) were added in culture medium during feedings at 4, 6, 8 and 10 days after plating. Cultures were used for all experiments ( FIGS. 1-4 ) on day 12. ODN sequences exhibited no similarity to any other known mammalian genes (BLAST search (10)). [0080] Immunoblotting was done as described in ref. “26”. Tissue was harvested and pooled from 2 cultures/lane. The blotted proteins were probed using a monoclonal anti-PSD-95 mouse IgG1 (Transduction Labs, 1:250 dilution), polyclonal anti PSD-93 (1:1000 dilution) and anti SAP-102 (1:2000 dilution) rabbit serum antibodies (Synaptic Systems GmbH), a monoclonal anti NR1 mouse IgG2a (PharMingen Canada, 1:1000 dilution) or a monoclonal anti nNOS (NOS type I) mouse IgG2a (Transduction Labs, 1:2500 dilution). Secondary antibodies were sheep anti-mouse, or donkey anti-rabbit Ig conjugated to horseradish peroxidase (Amersham). Immunoblots for PSD-95 were obtained for all experiments ( FIGS. 1-4 ) from sister cultures, and all gels quantified using an imaging densitometer (Bio-Rad GS-670). [0081] cGMP determinations were performed 10 min after challenging the cultures with NMDA, kainate, or high-K ( FIGS. 4 c - e ) with the Biotrak cGMP enzymeimmunoassay system according to the kit manufacturer's instructions (Amersham). Staining for NADPH diaphorase ( FIG. 4 b ) was done as described in ref. 12. [0082] Electrophysiology. Whole cell patch-clamp recordings in the cultured neurons were performed and analyzed as described in ref. 13. During each experiment a voltage step of −10 mV was applied from holding potential and the cell capacitance was calculated by integrating the capacitative transient. The extracellular solution contained (in mM): 140 NaCl, 5.4 KCl, 1.3 CaCl 2 , 25 HEPES, 33 glucose, 0.01 glycine, and 0.001 tetrodotoxin (pH=7.3-7.4, 320-335 mOsm). A multi-barrel perfusion system was employed to rapidly exchange NMDA containing solutions. The pipette solution contained (in mM): 140 CsF, 35 CsOH, 10 HEPES, 11 EGTA, 2 tetraethylammonium chloride (TEA), 1 CaCl 2 , 4 MgATP, pH 7.3 at 300 mOsm. Lucifer yellow (LY; 0.5% w/v) was included in the pipette for experiments in FIG. 3 d. [0083] Excitotoxicity and Ca 2+ accumulation measurements were performed identically to the methods described and validated in refs. 4 and 14. We used measurements of propidium iodide fluorescence as an index of cell death, and of radiolabelled 45 Ca 2+ accumulation for Ca 2+ load determinations in sister cultures on the same day. Experimental solutions were as previously described (4). Ca 2+ influx was pharmacologically channeled through distinct pathways as follows: To NMDARs by applying NMDA (×60 min) in the presence of both CNQX (Research Biochemicals Inc) and nimodipine (Miles Pharmaceuticals), to non-NMDARs by applying kainic acid (×60 min or 24 h) in the presence of both MK-801 (RBI) and nimodipine, and to VSCCs using 50 mM K + solution (×60 min) containing 10 mM Ca 2+ and S(−)-Bay K 8644, an L-type channel agonist (300-500 nM; RBI), MK-801 and CNQX. Antagonist concentrations were (in μM): MK-801 10, CNQX 10, nimodipine 2. All three antagonists were added after the 60 mM agonist applications for the remainder of all experiments (24 h). A validation of this approach in isolating Ca 2+ influx to the desired pathway in our cortical cultures has been published (4). [0084] Whole cell patch-clamp recordings in the cultured neurons were performed and analyzed as described in Z. Xiong, W. Lu, J. F. MacDonald, Proc Nail Acad Sci USA 94, 7012 (1997). During each experiment a voltage step of −10 mV was applied from holding potential and the cell capacitance was calculated by integrating the capacitative transient. The extracellular solution contained (in mM): 140 NaCl, 5.4 KCl, 1.3 CaCl 2 , 25 HEPES, 33 glucose, 0.01 glycine, and 0.001 tetrodotoxin (pH=7.3-7.4, 320-335 mOsm). A multi-barrel perfusion system was employed to rapidly exchange NMDA containing solutions. The pipette solution contained (in mM): 140 CsF, 35 CsOH, 10 HEPES, 11 EGTA, 2 tetraethylammonium chloride (TEA), 1 CaCl 2 , 4 MgATP, pH 7.3 at 300 mOsm. Lucifer yellow (LY; 0.5% w/v) was included in the pipette for experiments in FIG. 3D . [0085] Data analysis: data in all figures were analyzed by ANOVA, with a post-hoc Student's t-test using the Bonferroni correction for multiple comparisons. All means are presented with their standard errors. [0000] In greater detail: [0086] FIG. 1 , shows increased resilience of PSD-95 deficient neurons to NMDA toxicity in spite of Ca 2+ loading. A. Immunoblot showing representative effects of sham (SH) washes, and PSD-95 AS, SE and MS ODNs, on PSD-95 expression. PC: positive control tissue from purified rat brain cell membranes. Asterisk: non-specific band produced by the secondary antibody, useful to control for protein loading and blot exposure times. B. Densitometric analysis of PSD-95 expression pooled from N experiments. Asterisk: different from other groups, one-way ANOVA, F=102, p<0.0001. ODNs were used at 5 μM except where indicated (AS 2 μM). C. Representative phase contrast and propidium iodide fluorescence images of PSD-95 deficient (AS) and control (SE) cultures 24 h after a 60 min challenge with 30 μM NMDA. Scale bar: 100 μm. D. Decreased NMDA toxicity at 24 h in PSD-95 deficient neurons following selective NMDAR activation×60 min (n=16 cultures/bar pooled from N=4 separate experiments). Asterisk: differences from SE, MS and SH (Bonferroni t-test, p<0.005). Death is expressed as the fraction of dead cells produced by 100 μM NMDA in sham-ODN-treated controls (validated in 4, 14). E. No effect of PSD-95 deficiency on NMDAR-mediated Ca 2+ loading (n=12/bar, N=3; reported as the fraction of 45 Ca 2+ accumulation achievable over 60 min in the sham controls by 100 μM NMDA, which maximally loads the cells with calcium (4). [0087] FIG. 2 , shows that PSD-95 deficiency does not affect toxicity and Ca 2+ loading produced by activating non-NMDARs and Ca 2+ channels. Cultures were treated with SH washes or AS or SE ODNs as in FIG. 1 . A. Selective activation of AMPA/kainate receptors with kainate in MK-801 (10 μM) and nimodipine (NIM; 2 μM) produces toxicity over 24 h (A1) irrespective of PSD-95 deficiency, with minimal 45 Ca 2+ loading (A2). B. Selective activation of VSCCs produces little toxicity (B1), but significant 45 Ca 2+ loading (B2) that is also insensitive to PSD-95 deficiency. n=4 cultures/bar in all experiments. [0088] FIG. 3 , shows that there is no effect of perturbing PSD-95 on receptor function. A. Immunoblots of PSD-950DN-treated cultures probed for PSD-95, NR1, PSD-93, and SAP-102 using specific antibodies. PC: positive control tissue from purified rat brain cell membranes. B. NMDA dose-response curves and representative NMDA currents (inset) obtained with 3-300 μM NMDA. C. NMDA current density measurements elicited with 300 μM NMDA (AS: n=18; SE: n=19; SH: n=17; one-way ANOVA F=1.10, p=0.34), and analysis of NMDA current desensitization. I ss =steady-state current; I peak =peak current. AS: n=15; SE: n=16; SH: n=16 (ANOVA F=0.14, p=0.87). Time constants for current decay were AS: 1310±158 ms; SE, 1530±185 ms; SH: 1190±124 ms (ANOVA, F=1.22, p=0.31). D. Currents elicited with 300 μM NMDA in neurons dialyzed with LY (insert) and 1 mM tSXV or control peptide. [0089] FIG. 4 , shows the effect of coupling of NMDAR activation to nitric oxide signaling by PSD-95. A. L-NAME protects against NMDA toxicity (n=4, N=2). Asterisk: difference from 0 μM L-NAME (Bonferroni t-test, p<0.05). B. No effect of SH and of PSD-95 AS and MS ODNs on nNOS expression in cultures (immunoblot) and on NADPH diaphorase staining in PSD-95 AS and SE-treated neurons. PC: positive control tissue from purified rat brain cell membranes. C. Effect of isolated NMDAR activation on cGMP formation (n=12 cultures/bar pooled from N=3 separate experiments) D,E. Effects of VSCC activation (n=8/bar, N=2), and AMPA/kainate receptor activation (n=4/bar, N=1) on cGMP formation. Data in C-E are expressed as the fraction of cGMP produced in SE-treated cultures by 100 μM NMDA. Asterisk: differences from both SH and SE controls (Bonferroni t-test, p<0.0001). F. Sodium nitroprusside toxicity is similar in PSD-95 AS, SE and SH treated cultures. [0090] PSD-95 expression was suppressed in cultured cortical neurons to <10% of control levels, using a 15-mer phosphodiester antisense (AS) oligodeoxynucleotide (ODN) (FIG. 1 A,B) Sham (SH) washes, sense (SE) and missense (MS) ODNs (9) had no effect. The ODNs had no effect on neuronal survivability and morphology as gauged by viability assays, herein below, and phase-contrast microscopy (not shown). [0091] To examine the impact of PSD-95 on NMDAR-triggered excitotoxicity, ODN-treated cultures were exposed to NMDA (10-100 μM) for 60 min, washed, and either used for 45 Ca 2+ accumulation measurements, or observed for a further 23 h. Ca 2+ influx was isolated to NMDARs by adding antagonists of non-NMDARs and Ca 2+ channels (4). NMDA toxicity was significantly reduced in neurons deficient in PSD-95 across a range of insult severities (FIGS. 1 C,D; EC 50 : AS: 43.2±4.3; SE: 26.3±3.4, Bonferroni t-test, p<0.005). Concomitantly however, PSD-95 deficiency had no effect on Ca 2+ loading into identically treated sister cultures ( FIG. 1E ). Therefore, PSD-95 deficiency induces resilience to NMDA toxicity despite maintained Ca 2+ loading. [0092] I next examined whether the increased resilience to Ca 2+ loading in PSD-95 deficient neurons was specific to NMDARs. Non-NMDAR toxicity was produced using kainic acid (30-300 μM), a non-desensitizing AMPA/kainate receptor agonist (15), in the presence of NMDAR and Ca 2+ channel antagonists (4). Kainate toxicity was unaffected in PSD-95 deficient in neurons challenged for either 60 min (not shown) or 24 h (FIG. 2 A 1 ). Non-NMDAR toxicity occurred without significant 45 Ca 2+ loading (FIG. 2 A 2 ), as >92% of neurons in these cultures express Ca 2+ -impermeable AMPA receptors (4). However, Ca 2+ loading through VSCCs, which is non-toxic (4) (FIG. 2 B 1 ), was also unaffected by PSD-95 deficiency (FIG. 2 B 2 ). Thus, suppressing PSD-95 expression affects neither toxicity nor Ca 2+ fluxes triggered through pathways other than NMDARs. [0093] Immunoblot analysis (11) of PSD-95 deficient cultures revealed no alterations in the expression of the essential NMDAR subunit NR1, nor of two other NMDAR-associated MAGUKs, PSD-93 and SAP-102 ( FIG. 3A ). This indicated that altered expression of NMDARs and their associated proteins was unlikely to explain reduced NMDA toxicity in PSD-95 deficiency (FIG. 1 C,D). Therefore, I examined the possibility that PSD-95 modulates NMDAR function. NMDA currents were recorded using the whole-cell patch technique (16) ( FIG. 3B ). PSD-95 deficiency had no effect on passive membrane properties, including input resistance and membrane capacitance [Capacitance: AS 55.0±2.6 pF (n=18); SE 52.7±3.2 pF (n=19); SH 48.1±3.4 pF (n=17; ANOVA, F=1.29, p=0.28)]. Whole-cell currents elicited with 3-300 μM NMDA were also unaffected. Peak currents were AS: 2340±255 pA (n=18); SE: 2630±276 (n=19); SH: 2370±223 (n=17) ( FIG. 3B , inset; one-way ANOVA, F=0.43, p=0.65). NMDA dose-response relationships also remained unchanged ( FIG. 3B ; EC 50 AS: 16.1±0.8 μM (n=7); SE: 15.5±2.1 (n=6); SH: 15.9±2.9; one-way ANOVA, F=0.02, p=0.98), as were NMDA current density and desensitization ( FIG. 3C ). [0094] To further examine the effect of PSD-95 binding on NMDAR function, a 9 aa peptide, KLSSIESDV (SEQ ID NO: 1) corresponding to the C-terminal domain of the NR2B subunit characterized by the tSXV motif (6) was injected into the neurons. At 0.5 mM, this peptide competitively inhibited the binding of PSD-95 to GST-NR2B fusion proteins (6), and was therefore predicted to uncouple NMDARs from PSD-95. Intracellular dialysis of 1 mM tSXV or control peptide, CSKDTMEKSESL (SEQ ID NO: 3) (6) was achieved through patch pipettes (3-5 MΩ) also containing the fluorescent tracer Lucifer Yellow (LY). This had no effect on NMDA currents over 30 min despite extensive dialysis of LY into the cell soma and dendrites ( FIG. 3D ). Peak current amplitudes were tSXV: 2660±257 pA (n=9), control: 2540±281 pA (n=10; t (17) =0.31, p=0.76). [0095] The data is consistent with that obtained from recently generated mutant mice expressing a truncated 40K PSD-95 protein that exhibited enhanced LTP and impaired learning (17). Hippocampal CA1 neurons in PSD-95 mutants exhibited no changes in NMDAR subunit expression and stoichiometry, cell density, dendritic cytoarchitecture, synaptic morphology, or NMDAR localization using NR1 immunogold labeling of asymmetric synapses. NMDA currents, including synaptic currents, were also unchanged (16). I also found no effects of PSD-95 deficiency on NMDAR expression, on other NMDAR associated MAGUKs, nor on NMDA-evoked currents. In addition, NMDAR function gauged by measuring NMDA-evoked 45 Ca 2+ -accumulation was unaffected. Thus, the neuroprotective consequences of PSD-95 deficiency must be due to events downstream from NMDAR activation, rather than to altered NMDAR function. [0096] The second PDZ domain of PSD-95 binds to the C-terminus of NR2 subunits and to other intracellular proteins (8). Among these is nNOS (18), an enzyme that catalyzes the production of nitric oxide (NO), a short-lived signaling molecule that also mediates Ca 2+ -dependent NMDA toxicity in cortical neurons (12). Although never demonstrated experimentally, the NMDAR/PSD-95/nNOS complex was postulated to account for the preferential production of NO by NMDARs over other pathways (8). To determine whether NO signaling plays a role in NMDA toxicity in the present cultures, we treated the cells with N G -nitro-L-arginine methyl ester ( L -NAME), a NOS inhibitor (12). L -NAME protected the neurons against NMDA toxicity ( FIG. 4A ), indicating the possibility that suppressing PSD-95 might perturb this toxic signaling pathway. [0097] The effect of suppressing PSD-95 expression on NO signaling and toxicity was examined using cGMP formation as a surrogate measure of NO production by Ca 2+ -activated nNOS (20, 21). PSD-95 deficiency had no impact on nNOS expression ( FIG. 4B ), nor on the morphology ( FIG. 4B ) or counts of NADPH diaphorase-staining (12) neurons (SH: 361±60, SE: 354±54, AS: 332±42 staining neurons /10 mm coverslip, 3 coverslips/group). However, in neurons lacking PSD-95 challenged with NMDA under conditions that isolated Ca 2+ influx to NMDARs (4), cGMP production was markedly attenuated (>60%; FIG. 4C , one-way ANOVA, p<0.0001). Like inhibited toxicity (FIGS. 1 , 2 ), inhibited cGMP formation in neurons lacking PSD-95 was only observed in response to NMDA. It was unaffected in neurons loaded with Ca 2+ through VSCCs ( FIG. 4D ), even under high neuronal Ca 2+ loads matching those attained by activating NMDARs (compare FIGS. 1 E and 2 B 2 ) (4). nNOS function therefore, was unaffected by PSD-95 deficiency. AMPA/kainate receptor activation failed to load the cells with Ca 2+ (FIG. 2 A 2 ), and thus failed to increase cGMP levels ( FIG. 4E ). Our findings indicate that suppressing PSD-95 selectively reduces NO production efficiency by NMDAR-mediated Ca 2+ influx, but preserves NO production by Ca 2+ influx through other pathways. [0098] Bypassing nNOS activation with NO donors restored toxicity in neurons lacking PSD-95. The NO donors sodium nitroprosside (12) ( FIG. 4F ; EC 50 300 μM) and S-nitrosocysteine (17) (not shown) were highly toxic, irrespective of PSD-95 deficiency. Thus, reduced NMDA toxicity in PSD-95 deficient cells was unlikely to be caused by altered signaling events downstream from NO formation. [0099] Suppressing PSD-95 expression uncoupled NO formation from NMDAR activation ( FIG. 4C ), and protected neurons against NMDAR toxicity (FIG. 1 C,D) without affecting receptor function ( FIGS. 1E , 3 A-D), by mechanisms downstream from NMDAR activation, and upstream from NO-mediated toxic events ( FIG. 4F ). Therefore, PSD-95 imparts NMDARs with signaling and neurotoxic specificity through the coupling of receptor activity to critical second messenger pathways. These results have broader consequences, as NMDAR activation and NO signaling are also critical to neuronal plasticity, learning, memory, and behavior (1, 18, 19). Thus, these data provide experimental evidence for a mechanism by which PSD-95 protein may govern important physiological and pathological aspects of neuronal functioning. [0100] FIG. 5 shows the utility of Tat-peptides in dissociating the NMDAR/PSD-95 interaction (A) The hypothesis: The NMDAR/PSD-95 complex (left panel) may be dissociated using Tat peptides fused either to the C-terminus of NR2B (Tat-NR2B9c; middle) or to the first and second PDZ domains of PSD-95 (pTat-PDZ1-2; right), thus reducing the efficiency of excitotoxic signaling via Ca 2+ -dependent signaling molecules (B) Intracellular accumulation of Tat-NR2B9c-dansyl (10 μM) but not control peptide (Tat-38-48-dansyl; 10 μM) was observed 30 min after application to cortical neuronal cultures using confocal microscopy (excitation: 360 nm, emission: >510 nm; representative of 5 experiments). Fluorescence of cultures treated with Tat-38-48-dansyl was similar to background (not shown). (C) Time course of Tat-NR2B9c-dansyl (10 μM) fluorescence after application to cortical cultures at room temperature (symbols: mean±S.E of 4 experiments). Inset: fluorescence images from representative experiment (D) Tat-NR2B9c, but not control peptides (see text), inhibits the co-immunoprecipitation of PSD-95 with NR2B in rat forebrain lysates (Left: Representative gel; Right: means±S.E of 4 experiments, ANOVA, F=6.086, *p=0.0041). [0101] In more detail, a conserved tSXV motif at the C-terminus of the NR2B subunit is critical for binding to the PDZ2 domain of PSD-95. I hypothesized that interfering with this interaction might disrupt the coupling between NMDARs and PSD-95. This might be achieved by the intracellular introduction of exogenous peptides that bind to either the NR2B or the PDZ2 interaction domains ( FIG. 5A ). To this end I used a peptide comprised of the nine C-terminal residues of NR2B (KLSSIESDV; NR2B9c (SEQ ID NO: 1)), which is anticipated to bind the PDZ2 domain of PSD-95. As an alternative means to interfere with the NMDAR/PSD-95 interaction I constructed a protein comprised of residues 65-248 of PSD-95 encompassing the first and second PDZ domains (PDZ1-2), which contains the principal binding domain in PSD-95 for the C-terminus of NR2B. NR2B9c or PDZ1-2 on their own did not enter cells (not shown) and therefore, I fused each to a peptide corresponding to the cell-membrane transduction domain of the HIV-1-Tat protein (YGRKKRRQRRR (SEQ ID NO: 2); Tat) to obtain a 20 amino acid peptide (Tat-NR2B9c) and the fusion protein pTat-PDZ1-2. pTat-PDZ1-2 and pTat-GK fusion proteins were generated by insertion of PSD95 residues 65-248 encoding the PDZ 1 and 2, and residues 534-724 encoding the guanylate kinase-like domains, respectively, into pTAT-HA plasmids (generous gift of S. Dowdy, Washington University, St. Louis, Mo.). Fusion proteins contain a 6×His-tag, the protein transduction domain of HIV-1 Tat and a hemagglutinin-tag N-terminal to the insert. Plasmids were transformed into BL21(DE3)LysS bacteria (Invitrogen) and recombinant proteins were isolated under denaturing conditions on a Nickle-His column (Amersham-Pharmacia). These are anticipated to transduce cell membranes in a rapid, dose-dependent manner independent of receptors and transporters (30). [0102] To determine whether Tat-NR2B9c was able to transduce into neurons, I conjugated the fluorophore dansyl chloride to Tat-NR2B9c and to a control peptide comprised of HIV-1-Tat residues 38-48 (KALGISYGRKK (SEQ ID NO: 4); Tat38-48) outside the Tat transduction domain (31). [0103] Electrophysiological Recordings were made in 400 μm Hippocampal slices from 20-36 day old Sprague-Dawley rats perfused at room temperature with ACSF containing (in mM) 126 NaCl, 3 KCl, 2 MgCl 2 , 2 CaCl 2 , 1.2 KH 2 PO 4 , 26 NaHCO 3 and 10 glucose and bubbled with 95% O 2 /5% CO 2 . Whole-cell recordings of CA1 neurons were performed using the “blind” method with an Axopatch-1D amplifier (Axon Instruments, Foster City, Calif.) at holding potential −60 mV. Pipettes (4-5 MΩ) were filled with solution containing (mM): 135 CsCl, 2 MgCl 2 , 0.1 CaCl 2 , 0.5 EGTA, 10 HEPES, 4 Mg-ATP, 0.2 GTP, and 5 QX-314, pH 7.4, 310 mOsm. Field potentials were recorded with glass micropipettes (2-4 MΩ) filled with ACSF placed in the stratum radiatum 60-80 μm from the cell body layer. Synaptic responses were evoked by stimulation (0.05 ms) of the Schaffer collateral-commissural pathway with a bipolar tungsten electrode in the presence of bicuculline methiodide (10 μM). For I NMDA recording, Mg 2+ was removed from and 20 μM CNQX was added in ACSF. Following 10-20 min base line recordings of EPSCs, I NMDA and fEPSPs, Tat-peptides were applied in ACSF and recordings were continued for 30 min thereafter. [0104] I bath applied these to cultured cortical neurons and observed their fluorescence by confocal microscopy. Neurons treated with Tat-NR2B9c-dansyl (10 μM) exhibited fluorescence in their cytoplasm and processes, indicating intracellular peptide delivery ( FIG. 5B , left). Sister cultures treated with Tat38-48-dansyl (10 μM) exhibited only background fluorescence, indicating no observable peptide uptake in the absence of the Tat transduction domain ( FIG. 5B , right). Tat-NR2B9c-dansyl was detectable in the neurons within 10 min of the start of the application and the peptide accumulated to a maximum level over the next 20 min ( FIG. 5C ). This level was maintained until the dansyl-Tat-NR2B9c was washed from the bath and the peptide remained detectable within the neurons for more than 5 hours thereafter. Therefore, the Tat transduction domain was able to act as a carrier for NR2B9c and the Tat-NR2B9c fusion peptide remained in neurons for many hours after being applied extracellularly. [0105] To determine whether Tat-NR2B9c may disrupt the interaction between NMDARs and PSD-95 I made use of rat brain proteins prepared under weakly denaturing conditions known to permit the NMDAR/PSD-95 interaction. Adult (7-8W) wistar rat forebrains were removed and homogenized in ice-cold buffer (0.32M Sucrose, 0.1 mM Na3VO4, 0.1 mM PMSF, 0.02M PNPP, 0.02M glycerol phosphate, and 5 ug/ml each of antipain, aprotinin, and leupeptin). Homogenates were centrifuged at 800 gr for 10 min at 4° C. The supernatants were combined and centrifuged at 11,000 g at 4 degree for 20 min and the pellet (P2) was resuspended in homogenization buffer. P2 membranes were adjusted 200 ug protein/90 ul with homogenization buffer with a final concentration of 1% DOC and 0.1% Triton X-100. The proteins were incubated with Tat-NR2B9c or with one of three controls: Tat38-48, the Tat transduction sequence conjugated to two alanine residues (Tat-AA), or a Tat-NR2B9c peptide in which the C-terminal tSXV motif contained a double point mutation (Tat-KLSSIEADA; Tat-NR2BAA) rendering it incapable of binding PSD-95. I immunoprecipated NMDARs, together with associated proteins, with an antibody that selectively recognizes NR2B. The proteins were separated by SDS-PAGE and probed with anti-PSD-95 or anti-NR2B antibodies 16 NR2B was precipitated from rat forebrain extracts using a polyclonal rabbit anti-NR2B antibody generated against the C-terminal region encompassing amino acid residues 935-1,455 of the NR2B protein. Proteins were then separated on 8% SDS-PAGE gels and probed with monoclonal anti-NR2B (Clone 13, Transduction Laboratories) or anti PSD-95 antibodies (Clone 7E3-1B8, Affinity Bioreagents. Inc). Detection of proteins was achieved using HRP-conjugated secondary antibodies and enhanced chemiluminescence. I found that Tat-NR2B9c reduced the co-immunoprecipitation of PSD-95 with NR2B. On average the optical density signal was reduced by 37.6±8.2% as compared with controls ( FIG. 5D ). In contrast, none of the three control peptides reduced the co-immunoprecipitation of PSD-95 with NR2B. Thus, I conclude that Tat-NR2B9c disrupts the interaction between NMDARs and PSD-95 and that this is dependent upon an intact PDZ binding motif in the peptide. [0106] FIG. 6 shows neuroprotection and reduction of NO signaling by Tat-peptides without affecting NMDAR function (A) Effect of Tat-NR2B9c (50 nM) on field excitatory post-synaptic currents (fEPSC) in CA1 neurons in acute hippocampal slices. (B) Effect of 50 nM Tat-NR2B9c or Tat-38-48 (control) on whole-cell excitatory post synaptic currents (EPSC). (C) Effect of Tat-NR2B9c on the NMDA component of the EPSC isolated pharmacologically by applying the AMPAR antagonist CNQX, and concomitant removal of extracellular Mg 2+ . (D) Effect of 50 nM Tat-NR2B9c treatment on NMDA-evoked 45 Ca 2+ uptake in cortical cultures. Tat-peptides were bath-applied 1 h prior to the NMDA application. (E) Effect of 50 nM Tat-NR2B9c treatment on NMDA-evoked cGMP production in cortical cultures. Asterisk: differences from control and Tat-NR2B-AA at each NMDA concentration (Bonferroni t-test, p<0.01). (F) Decreased excitotoxicity at 20 h at all NMDA concentrations in cultured cortical neurons pre-treated with 50 nM Tat-NR2B9c or pTat-PDZ1-2 for 1 h. Asterisk: differences from control, Tat-NR2B-AA and pTat-GK at each NMDA concentration (Bonferroni t-test, p<0.005). Right panels: Representative phase contrast and propodium iodide fluorescence images of cultures 20 h after challenge with 100 μM NMDA with and without Tat-NR2B9c treatment. Bars in (D), (E) and (F) indicate the mean±S.E. for 12 cultures in 3 separate experiments. [0107] In more detail, as NMDAR-mediated synaptic responses are not altered by the loss of PSD-95 (24) I predicted that Tat-NR2B9c would not affect the function of NMDARs. This was tested by examining the effect of Tat-NR2B9c on NMDAR-mediated currents and on NMDA-evoked uptake of 45 Ca 2+ . Bath-applying Tat-NR2B9c (50 nM) to acute rat hippocampal slices had no effect on synaptic responses of CA1 neurons evoked by stimulation of the Schaffer collateral-commissural pathway ( FIG. 6A ) nor on patch recordings of the total excitatory post-synaptic currents (EPSC) recorded in CA1 neurons, ( FIG. 6B ) nor on the pharmacologically isolated AMPA (not shown) or NMDA components of the EPSC ( FIG. 6C ). Moreover, using cortical cultures I found that pre-treating cultures with Tat-NR2B9c or with pTat-PDZI-2 (each at 50 nM) did not alter the uptake of 45 Ca 2+ produced by applying NMDA ( FIG. 6D ); CNQX (10 μM) and nimodipine (2 μM) were present in the extracellular solution in these and all subsequent experiments using cultured neurons so as to isolate signaling and thereby preventing secondary activation of AMPARs or of voltage-gated Ca 2+ channels, respectively (25,32,33). [0108] As the function of NMDARs was unaffected by administering Tat-NR2B9c, I next determined whether this peptide altered signaling events downstream of NMDAR activation. To this end I examined stimulation of nNOS, as a key downstream signaling enzyme that mediates the neurotoxic effects of NMDAR activation 5 . I measured NMDA-evoked changes in the levels of guanosine 3′,5′-monophosphate (cGMP) as a surrogate measure of NO production by NMDAR stimulated nNOS activity 7,20 . Cultured cortical neurons were pre-treated for 1 h with Tat-NR2B9c (50 nM), the non-interacting Tat-NR2B-AA (50 nM) or with sham washes and challenged with NMDA (0-1000 μM) in the presence of CNQX and nimodipine as above. NMDA produced a concentration-dependent increase in cGMP that was significantly suppressed (average of 39.5±6.7%) by pre-treating the cultures with Tat-NR2B9c ( FIG. 6E ). In contrast, NMDAR-stimulated elevation of cGMP was unaffected by pre-treatment with Tat-NR2B-AA. Thus, Tat-NR2B9c, but not a mutant peptide incapable of interacting with PSD-95, depressed NMDAR-evoked stimulation of NO-cGMP signaling. [0109] Although Tat-NR2B9c and pTat-PDZ1-2 did not affect NMDAR function, Tat-NR2B9c was shown to interfere with NMDAR/PSD-95 binding and to suppress downstream NO signaling. Thus, I predicted that Tat-peptide treatment should enhance neurons' resilience to NMDA toxicity. To test this I pre-treated cortical neuronal cultures with Tat-peptides (50 nM) for 1 h, then applied NMDA (0-100 μM) for 1 h followed by a 20 h observation period ( FIG. 6F , inset). Control neurons were treated with sham washes, or with the non-interacting control Tat-NR2BAA. In cultures treated with Tat-NR2B9c, cell death was significantly reduced at all concentrations tested ( FIG. 6F ) whereas pre-treatment with Tat-NR2B-AA had no effect on cell death. Thus, NMDAR-stimulated neurotoxicity is suppressed by pre-treatment with Tat-NR2B9c, suppression that is lost by mutating the PSD-95 binding region of the peptide. [0110] If Tat-NR2B9c suppresses NMDA excitotoxicity by interfering with the binding of NR2B to PSD-95 then interfering with this binding by an alternative means should also suppress the toxicity. I tested pTat-PDZ1-2, predicted to interfere with PSD-95 binding to NR2B and which permeates into the cells (not shown), though without effect on NMDA-evoked Ca 2+ accumulation ( FIG. 6D ). Pre-treating the cultures with pTat-PDZ1-2 attenuated the neurotoxicity of NMDA to a similar degree as Tat-NR2B9c ( FIG. 6F ). As a control, I made and used pTat-GK, a Tat fusion protein containing residues 534-724 of PSD-95 comprising the carboxyl-terminal guanylate-kinase homology domain that lacks enzymatic activity 21 . pTat-GK, which is devoid of the necessary domains to bind NR2B, had no effect on the NMDA-evoked cell death ( FIG. 6F ). Thus, interfering with the NMDAR/PSD-95 interaction using peptides that target either side of the interaction reduces in vitro excitotoxicity produced by NMDAR activation. [0111] FIG. 7 shows neuroprotection by Tat-NR2B9c pretreatment in-vivo. (A) Detection of Tat-NR2B9c-dansyl but not Tat38-48-dansyl in the cortex of C57BL/6 mouse brain 1 h after intraperitoneal injection (0.5 μmole total dose). Fluorescence of brains from animals treated with Tat-38-48-dansyl was similar to background (not shown). (B) Composite neurological scores (see text) during and 24 h after MCAo. (C) Pre-treatment with 3 nmole/g Tat-NR2B9c but not mutated Tat-NR2B-AA or saline (control) significantly reduced (i) total infarct area and volume (inset), ANOVA; F=7.3, p<0.005 and (ii) cortical infarct area and volume (inset), ANOVA; F=8.35, p<0.005 measured 24 h after transient MCAo. (n=6 animals per group; symbols and bars indicate mean±S.E). Infarct volume was calculated by analyzing the infarct area in 8 stereotactic coordinates of the brain as shown at right inset. [0112] Agents that block NMDAR activity were initially deemed as promising neuroprotectants for stroke and other neurological disorders involving excitotoxic mechanisms, but were later shown to be deleterious or ineffective in animal and human studies (27,28,29). However, Tat-peptides that target the NMDAR/PSD-95 interaction protect against NMDA toxicity without blocking NMDARs. Therefore I reasoned that treatment with Tat-NR2B9c in vivo could serve as an improvement on NMDA blockers in the treatment of ischemic brain damage. [0113] Before testing this I determined whether Tat-NR2B9c could be delivered into the brain in the intact animal. I injected 25 g C57BL/6 mice intraperitoneally with a 500 μmole dose of either Tat-NR2B9c-dansyl, or with Tat38-48-dansyl as a non-transducing control. 40 μm cryostat coronal brain sections taken 1 h after injection 22 were examined for peptide uptake using dansyl fluorescence detection by confocal microscopy. The mice were perfused with fixative solution (3% paraformaldehyde, 0.25% glutaraldehyde, 10% sucrose, 10 U/mL heparin in Saline) 1 hour after peptide injection. Brains were removed, frozen in 2-methylbutane at −42° C. and 40 m sections were cut using a Leitz Cryostat. Brain sections from animals injected with Tat-NR2B9c exhibited strong fluorescence in the cortex ( FIG. 7A , right), and in all other areas examined (hippocampus, striatum; not shown), whereas signal from controls remained at background levels ( FIG. 7A , left). Similar results were obtained using intravenous injection in rats (not shown). Thus, Tat-NR2B9c enters the brain upon peripheral administration. [0114] Next, I examined whether pretreatment with Tat-peptides would reduce stroke damage. Experiments were carried out in adult male Sprague-Dawley rats subjected to transient middle cerebral artery occlusion (MCAO) for 90 minutes by the intraluminal suture method (36,37). Animals were fasted overnight and injected with atropine sulfate (0.5 mg/kg IP). After 10 minutes anesthesia was induced with 3.5% halothane in a mixture of nitrous oxide and oxygen (Vol. 2:1) and maintained with 0.8% halothane. Rats were orally intubated, mechanically ventilated, and paralyzed with pancuronium bromide (0.6 mg/kg IV). Body temperature was maintained at 36.5-37.5° C. with a heating lamp. Polyethylene catheters in the femoral artery and vein were used to continuously record blood pressure and to sample blood for gas and pH measurements. Transient MCAO was achieved for 90 min by introducing a poly-L-lysine-coated 3-0 monofilament nylon suture (Harvard Apparatus) into the circle of Willis via the internal carotid artery, effectively occluding the middle cerebral artery. This produces an extensive infarction encompassing the cerebral cortex and basal ganglia. Animals were pretreated with either saline, the Tat-NR2B-AA control, or with Tat-NR2B9c by a single intravenous bolus injection 45 min prior to MCAO (3 nMoles/g). Physiological parameters (body temperature, blood pressure, blood gases) were monitored and maintained throughout the experiment (Table 1). All experimental manipulations and analyses of data were performed by individuals blinded to the treatment groups. The extent of cerebral infarction was measured 24 h after MCAO onset ( FIG. 7C inset). The postural reflex test (38), and the forelimb placing test (39) were used to grade neurological function on a scale of 0 to 12 (normal=0; worst=12) during MCAO (at 50 minutes) and 24 h thereafter. [0115] Pretreatment with Tat-NR2B9c produced a trend toward improvement in 24 h neurological scores in animals treated with Tat-NR2B9c ( FIG. 7B ). Moreover, the treatment reduced the volume of total cerebral infarction by 54.6±11.27% as compared with stroke volume in controls (FIG. 7 C,; ANOVA, F=7.289, p=0.0048). This effect was largely accounted-for by a 70.7±11.23% reduction in cortical infarction ( FIG. 7C , ANOVA, F=8.354, p=0.0027), which is thought to be largely caused by NMDAR-dependent mechanisms. [0116] A treatment for stroke with a single-bolus drug injection would be most therapeutically valuable if effective when given after the onset of ischemia. I thus first evaluated whether treatment with Tat-peptides could be neuroprotective when applied post-insult in vitro. [0117] FIG. 8 shows neuroprotection by post-treatment with Tat-NR2B9c in-vitro and in-vivo (A) Decreased excitotoxicity at 20 h in cultured cortical neurons post-treated with 50 nM Tat-NR2B9c or pTat-PDZ1-2 at 1 h after NMDA application. Bars indicate the mean±S.E. for 12 cultures in 3 separate experiments. Asterisk: differences from control, Tat-NR2B-AA and pTat-GK at each NMDA concentration (Bonferroni t-test, p<0.005). Right panels: Representative phase contrast and propodium iodide fluorescence images of cultures 24 h after challenge with 100 μM NMDA with and without Tat-NR2B9c treatment. (B) Composite neurological scores (see text) during and 24 h after MCAo. Asterisk: difference from control and Tat-NR2B-AA (ANOVA; F=17.25, p<0.0001). (C) Post-treatment with 3 nmole/g Tat-NR2B9c (9 animals) but not mutated Tat-NR2B-AA (8 animals) or saline controls (10 rats) significantly reduced (i) total infarct area and volume (inset), ANOVA; F=12.0, p<0.0005 and (ii) cortical infarct area and volume (inset), ANOVA; F=12.64, p=0.0001 as measured 24 h after transient MCAo. Symbols and bars indicate mean±S.E (D). Representative appearance of H&E stained rat brain sections from which the infarct areas were analyzed. [0118] Cultured cortical neurons were exposed to an NMDA challenge (0-100 μM) for 1 h and were then treated with the Tat-peptides (all at 50 nM) described in the pre-treatment study ( FIG. 6F ). Cell death was gauged 20 h thereafter (FIG. 8 A—inset). Post-treatment with Tat-NR2B9c or with pTat-PDZ 1-2 significantly reduced the vulnerability of neurons to NMDA toxicity as compared with control cultures post-treated with sham washes, with Tat-NR2BAA, or with pTat-GK ( FIG. 8A ). Thus, when administered 1 hr after the start of the NMDA insult each of the Tat fusion constructs that target the NMDAR/PSD-95 interaction significantly reduced neuronal cell death in vitro. [0119] Finally, I examined whether treatment with Tat-NR2B9c could attenuate ischemic neuronal damage in-vivo when given after stroke onset. A post-treatment study was conducted in which the rats were subjected to transient MCAO for 90 minutes as before, but the intravenous saline or Tat-peptide bolus (Tat-NR2B9c or Tat-NR2B-AA; 3 nMole/g) was injected 1 h after MCAO onset (FIG. 8 C—inset). Infarction volume and neurological outcome measurements were performed at times identical to the pre-treatment study. Body temperature, blood pressure and blood gases were monitored throughout the 24 h experiment and maintained equivalent between groups (Table 2). [0120] Post-treatment with Tat-NR2B9c, but not with Tat-NR2B-AA or saline, resulted in animals exhibiting a significant improvement in 24 h neurological scores as compared with controls ( FIG. 8B ; ANOVA, F=17.25, p<0.0001). Most strikingly, post-treatment with Tat-NR2B9c reduced the volume of total cerebral infarction by 67.0±3.75% as compared with stroke volume in controls ( FIG. 8C ; ANOVA, F=11.99, p=0.0002). Similar to the previous study, this reduction was accounted-for by a 86.97±4.38% reduction in cortical infarction volume ( FIG. 8C , 4 D; ANOVA, F=12.64, p<0.0001). [0121] The aforesaid description demonstrates that introducing into cells an exogenous peptide containing the C-terminal nine amino acids of the NR2B NMDAR subunit has profound effects on signaling pathways downstream of NMDAR activation, on in vitro excitotoxicity, and on in vivo ischemic brain damage. The effects of this peptide are lost by mutating amino acids that are essential for mediating PDZ binding to PSD-95. In addition, a protein comprising PDZ1-2 of PSD-95 shares the effects of the NR2B C-terminal peptide. Together these findings imply that the downstream signaling from NMDARs that leads to negative consequences for neuronal viability may be interrupted by interfering with the interaction between NR2B and PSD-95. [0122] I have discovered that the strategy of treating neurons with Tat-fusion peptides is effective in reducing vulnerability to excitotoxicity in vitro and stroke damage in vivo. As this occurs without affecting NMDAR activity then adverse consequences of blocking NMDARs are not expected. Efficacy after the insult onset suggests that targeting the NMDAR/PSD-95 interaction is a practical future strategy for treating stroke. It is also likely that targeting other intracellular proteins using the same approach could be used to modulate additional signaling mechanisms mediated by protein-protein interactions that lead to other human diseases. [0000] TABLE 1 Physiological Variables in Pre-Treatment MCAO Study Control TAT-NR2BAA TAT-NR2B9c Physiological Variables (n = 6) (n = 6) (n = 6) Before anesthesia Body weight, g 269 ± 6  273 ± 7  271 ± 5  Before MCAo(45 min) Body Temperature, ° C. 36.7 ± 0.07 36.7 ± 0.17 36.6 ± 0.21 MABP, mmHg 119 ± 4  115 ± 5  120 ± 9  Before MCAo(30 min) Body Temperature, ° C. 36.8 ± 0.08 36.5 ± 0.12 36.7 ± 0.19 MABP, mmHg 107 ± 3  110 ± 4  76 ± 5* Blood gases PH 7.44 ± 0.02 7.44 ± 0.02 7.44 ± 0.02 PO2, mmHg 104 ± 3  110 ± 7  123 ± 8  PCO2, mmHg 39.6 ± 1.3  39.1 ± 1.4  38.1 ± 1.4  Before MCAo(15 min) Body Temperature, ° C. 36.9 ± 0.11 36.6 ± 0.15 36.7 ± 0.20 MABP, mmHg 111 ± 6  115 ± 5  90 ± 6* During MCAo (5 min) Body Temperature, ° C. 36.9 ± 0.03 36.6 ± 0.17 36.7 ± 0.16 MABP, mmHg 132 ± 6  135 ± 7  112 ± 9  Blood gases PH 7.44 ± 0.02 7.44 ± 0.02 7.44 ± 0.02 PO2, mmHg 118 ± 3  109 ± 4  112 ± 6  PCO2, mmHg 39.2 ± 0.6  39.6 ± 0.5  41.0 ± 1.3  During MCAo (15 min) Body Temperature, ° C. 36.9 ± 0.09 36.7 ± 0.15 36.8 ± 0.23 MABP, mmHg 116 ± 9  111 ± 6  98 ± 6  After MCAo (15 min) Body Temperature, ° C. 36.9 ± 0.09 36.8 ± 0.08 36.8 ± 0.12 After MCAo (24 hr) Body Temperature, ° C. 36.6 ± 0.14 37.0 ± 0.25 36.5 ± 0.14 Body weight, g 238 ± 6  244 ± 6  250 ± 5  MABP: Mean arterial blood pressure *P < 0.05, Student's t-test [0000] TABLE 2 Physiological Variables in Post-Treatment MCAO Study Control TAT-NR2BAA TAT-NR2B9c Physiological Variables (n = 10) (n = 8) (n = 9) Before anesthesia Body weight, g 314 ± 4  301 ± 5  306 ± 7  Before MCAo(15 min) Body Temperature, ° C. 36.9 ± 0.07 36.7 ± 0.07 36.6 ± 0.07 MABP, mmHg 103 ± 4  103 ± 6  103 ± 5  Blood gases PH 7.43 ± 0.01 7.45 ± 0.01 7.43 ± 0.02 PO2, mmHg 113 ± 4  113 ± 4  105 ± 4  PCO2, mmHg 39.4 ± 1.0  37.9 ± 1.1  40.1 ± 1.0  During MCAo (15 min) Body Temperature, ° C. 36.9 ± 0.07 36.7 ± 0.11 37.0 ± 0.07 MABP, mmHg 120 ± 5  121 ± 5  119 ± 8  Blood gases PH 7.44 ± 0.01 7.46 ± 0.01 7.43 ± 0.01 PO2, mmHg 113 ± 3  108 ± 2  111 ± 4  PCO2, mmHg 39.3 ± 0.7  48.0 ± 1.2  39.8 ± 0.9  During MCAo (60 min) Body Temperature, ° C. 37.1 ± 0.21 37.0 ± 0.31 36.7 ± 0.11 MABP, mmHg 146 ± 5  149 ± 4  143 ± 5  During MCAo (65 min) Body Temperature, ° C. 37.1 ± 0.16 37.0 ± 0.29 36.9 ± 0.08 MABP, mmHg 134 ± 6  136 ± 5  137 ± 4  After MCAo (15 min) Body Temperature, ° C. 37.0 ± 0.09 36.9 ± 0.23 36.8 ± 0.08 MABP, mmHg 128 ± 6  116 ± 4  119 ± 4  After MCAo (24 hr) Body Temperature, ° C. 36.6 ± 0.14 36.7 ± 0.27 36.4 ± 0.24 Body weight, g 276 ± 3  276 ± 6  279 ± 8  MCAo: Middle cerebral artery occlusion; MABP: Mean arterial blood pressure [0123] Although this disclosure has described and illustrated certain preferred embodiments of the invention, it is to be understood that the invention is not restricted to those particular embodiments. Rather, the invention includes all embodiments which are functional or mechanical equivalence of the specific embodiments and features that have been described and illustrated.

1a

FIELD OF THE INVENTION This invention describes a chemical process of formulating micro-nanoparticulate pharmaceutical agent dispersions that have average particle diameters as small as 10 nm. BACKGROUND OF THE INVENTION Bioavailability is the degree to which a drug becomes available to the target tissue after administration. Many factors can affect bioavailability including the dosage form and various properties, e.g., dissolution rate of the drug. Poor bioavailability is a significant problem encountered in the development of pharmaceutical compositions, particularly those containing an active ingredient that is poorly soluble in water. Poorly water soluble drugs, i.e., those having a solubility less than about 10 mg/mL, tend to be eliminated from the gastrointestinal tract before being absorbed into the circulation. Moreover, poorly water soluble drugs tend to be unsafe for intravenous administration techniques, which are used primarily in conjunction with fully soluble drug substances. It is known that the rate of dissolution of a particulate drug can increase with increasing surface area, i.e., decreasing particle size. Consequently, methods of making finely divided drugs have been studied and efforts have been made to control the size and size range of drug particles in pharmaceutical compositions. For example, dry milling techniques have been used to reduce particle size and hence influence drug absorption. However, in conventional dry milling, as discussed by Lachman, et al., The Theory and Practice of Industrial Pharmacy, Chapter 2, "Milling," p. 45, (1986), the limit of fineness is reached in the region of 100 microns (100,000 nm) when material cakes on the milling chamber. Lachnan, et al. note that wet grinding is beneficial in further reducing particle size, but that flocculation restricts the lower particle size limit to approximately 10 microns (10,000 nm). However, there tends to be a bias in the pharmaceutical art against wet milling due to concerns associated with contamination. Commercial airjet milling techniques have provided particles ranging in average particle size from as low as about 1 to 50 μm (1,000-50,000 nm). Other techniques for preparing pharmaceutical compositions include loading drugs into liposomes or polymers, e.g., during emulsion polymerization. However, such techniques have problems and limitations. For example, a lipid soluble drug is often required in preparing suitable liposomes. Further, unacceptable large amounts of the liposome or polymer are often required to prepare unit drug doses. Further still, techniques for preparing such pharmaceutical compositions tend to be complex. A principal technical difficulty encountered with emulsion polymerization is the removal of contaminants, such as unreacted monomer or initiator, which can be toxic, at the end of the manufacturing process. U.S. Pat. No. 4,540,602 (Motoyama, et al.) discloses a solid drug pulverized in a aqueous solution of a water-soluble high molecular weight substance using a wet grinding machine. However, Motoyama, et al. teach that as a result of such wet grinding, the drug is formed into finely divided particles ranging from 0.5 μm (500 nm) or less to 5 μm (5,000 nm) in diameter. EPO 275,796 describes the production of colloidally dispersible systems comprising a substance in the form of spherical particles smaller than 500 nm. However, the method involves a precipitation effected by mixing a solution of the substance and a miscible non-solvent for the substance and results in the formation of non-crystalline nanoparticle. A somewhat more involved solvent shift method is described in U.S. Pat. No. 4,826,689 (Violanto) which produces uniform particles of drugs with diameters ranging between 0.5 to 1.0 μm. Furthermore, solvent precipitation techniques for preparing particles tend to provide particles contaminated with solvents. Such solvents are often toxic and can be very difficult, if not impossible, to adequately remove to pharmaceutically acceptable levels to be practical. U.S. Pat. No. 4,107,288 describes particles in the size range from 10 to 1,000 nm containing a biologically or pharmaceutically active material. However, the particles comprise a crosslinked matrix of macromolecules having the active material supported on or incorporated into the matrix. Such polymeric material may accumulate in the body and cause toxic effects. U.S. Pat. No. 4,725,442 (Haynes) describes water insoluble drug materials solubilized in an organic liquid and incorporated in microencapsules of phospholipids. However, the toxic effects of solubilizing organic liquids is difficult to overcome. Other methods of formation of pharmaceutical drug microencapsules include: a) Micronizing a slightly-soluble drug by subjecting a mixture of the drug and a sugar or sugar alcohol to high-speed stirring comminution or impact comminution (EP 411,629A) together with suitable excipients or diluents. Such a method of encapsule formation does not lead to particle size as small as obtained by milling. b) Polymerization of a monomer in the presence of the active drug material and a surfactant can lead to small-particle microencapsule (International Journal of Pharmaceutics, Vol. 52, pp. 101-108, 1989). This process, however, contains difficult-to-remove contaminants such as toxic monomers. Complete removal of such monomers can be expensive in manufacturing scales. c) Co-dispersion of a drug or a pharmaceutical agent in water with droplets of carbohydrate polymer has been disclosed (U.S. Pat. No. 4,713,249 and WO-84/00294). The major disadvantage of the procedure is that in many cases, a solubilizing organic co-solvent is needed for the encapsulation procedure. Removal of traces of such harmful co-solvents can lead to expensive manufacturing processes. Recently, many successful stable dispersions of nanoparticulate drug or pharmaceutical compositions have been prepared by wet milling of the agent in the presence of surfactants, polymers, block polymers, and oligomers as a mixture thereof as surface modifiers to produce sterically stabilized dispersions of nanoparticulates with particle diameters less than 400 nm (U.S. Pat. No. 5,145,684, WPI 87-200422/29, EP 0,498,482 A2). This wet milling procedure still leads to the incorporation of solubilized heavy metals from the attrition of the milling media, which in many cases must be removed from the dispersion by tedious ion exchange procedures to formulate the final pharmaceutical product. It is also well known that wet media milling procedures can not reduce average particle diameter to much less than 100 nm. It is noted that filed concurrently herewith are a) EK Docket No. 71869 entitled, "Microprecipitation of Nanoparticulate Pharmaceutical Agents" by Pranab Bagchi et al; b) EK Docket 71870 entitled, "Co-Microprecipitation of Nanoparticulate Pharmaceutical Agents with Crystal Growth Modifiers" by Pranab Bagchi et al; and c) EK Docket No. 71871 entitled, "Microprecipitation of Nanoparticulate Pharmaceutical Agents Using Surface Active Material Derived from Similar Pharmaceutical Agents" by Pranab Bagchi et al. It would be very desirable to provide stable dispersible pharmaceutical agent (both therapeutic and diagnostic) particles in size range that is much less than 100 nm in diamer which can be readily prepared, which do not appreciably flocculate or agglomerate due to interparticle attraction forces, and do not require the presence of a crosslinked matrix, simultaneously providing enhanced bioavailability of the drug. Furthermore, it would be highly desirable that such formulations do not involve removal of toxic residues such as toxic solvents or heavy metal solubilizates that arise out of attrition of the milling media. SUMMARY OF THE INVENTION We have discovered a novel process of producing micro-nanoparticulate dispersions that can be precipitated to form dispersions with average particle diameters up to less than 10 nm, for highly enhanced bioavailability. Such pharmaceutical agents are derived by chemical attachment of pharmaceutically useful chemical compositions (PUCC) to photographic coupler molecules that are capable of formation of dispersion particles of average diameters less than up to 10 nm. The PUCC groups are attached to the photographic coupler molecules via chemical groups on a simple bond designated as "Link". ##STR1## The photographic coupler modified pharmaceutical agent (PCMPA) compositions can be further converted to micro-nanoparticulate dispersions in the presence of a surface modifying and colloid stability enhancing surface active agent free of any solubilized heavy metal impurities by the following procedural steps: 1. Dissolving the said pharmaceutical agent (PCMPA) in aqueous base and a non toxic water miscible solvent with stirring, 2. Adding above #1 formulation with stirring to a solution of surface active surfactant (or surface modifier) or a mixture thereof to form a clear solution, and, 3. Neutralizing above formulation #2 with stirring with an appropriate acid solution. This procedure can be followed by: 4. Removal of formed salt by dialysis or diafiltration and 5. Concentration of dispersion by conventional means. The process of this invention is illustrated in FIG. 1. The process of this invention produces dispersions of pharmaceutical agents with Z-average particle diameter less than 100 nm and preferrably less than 10 nm (as measured by photon correlation spectroscopy) that are stable in particle size upon keeping under room temperature or refrigerated conditions. Such dispersions also demonstrate limited particle size growth upon autoclave-decontamination conditions used for standard blood-pool pharmaceutical agents. There can also be provided a pharmaceutical composition comprising the above-described particles and a pharmaceutically acceptable carrier thereof. Such pharmaceutical composition is useful in a method of treating mammals. It is an advantageous feature that a wide variety of surface modified drug micro-nanoparticles free of unacceptable contamination can be prepared in accordance with this invention. Another particularly advantageous feature of this invention is that pharmaceutical compositions are provided exhibiting unexpectedly high bioavailability because of their ultra small particle size. Still another advantageous feature of this invention is that pharmaceutical compositions containing poorly water soluble drug substances are provided which are suitable for intravenous administration techniques. In other preferred embodiments of this invention, step 3 (FIG. 1) can be carried out in semicontinuous, continuous batch, or continuous methods at constant flow rates of the reacting components in computer-controlled reactors or in tubular reactors where reaction pH can be kept constant using pH-stat systems, as will be described in "Description of Preferred Embodiments." Advantages of such preferred modifications of this invention are clear in that they provide cheaper manufacturing procedures for large-scale production of micro-nanoparticulate dispersion systems. Another advantage of the invention is that unlike a milled dispersion, the final product is free of heavy metal contaminants arising from the milling media that must be removed due to their toxicity before product is formulated. A further advantage of the method is that unlike some solvent precipitation, the final produce of this invention is free of any toxic solvents as only non toxic water miscible solvents that can be removed by diafiltration on dialysis are used. One of the major advantages of such micro-nanoparticulate dispersions is that the formulated dispersion need not be sterilized by autoclaving which usually causes some particle size growth. The micro-nanoparticulate pharmaceutical agent dispersions can be sterilized by sterile filtration at room temperature through successive filters with average pore size ranging from 1000 nm to 200 nm. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 Schematic for the microprecipitation of micro-nanoparticulate pharmaceutical agents. FIG. 2 Schematic for large-scale manufacture of micro-nanoparticulate pharmaceutical agents. FIG. 3 Schematic for large-scale manufacture of micro-nanoparticulate pharmaceutical agents using base hydrolyzable surface modifying compounds. FIG. 4 Schematic for large-scale manufacture of micro-nanoparticulate pharmaceutical agents using base hydrolyzable surfactants by continuous direct mixing. FIG. 5 Schematic for the small-scale pH-controlled microprecipitation device. FIG. 6 Schematic for the larger-scale pH-controlled microprecipitation device. FIG. 7 Schematic for alternate small-scale precipitation of pharmaceutical agents. FIG. 8 Schematic of continuous tubular microprecipitation device of this invention. FIG. 9 Cryo-transmission electron photomicrograph of nanoparticulate X-ray contrast agent "PCMPA #1" as prepared by the method of this invention in Example 2. FIG. 10 PCS particle size distribution of micro-nanoparticulate dispersion of PCMPA #1 prepared in Example 2 of this invention. FIG. 11 Cryo-transmission photomicrograph of micro-nanoparticulate X-ray contrast agent PCMPA #1 as prepared by the method of this invention in Example 3. FIG. 12 PCS particle size distribution of micro-nanoparticulate dispersions of PCMPA #1 prepared in Example 2 of this invention. DESCRIPTION OF PREFERRED EMBODIMENTS This invention is based on the discovery that pharmaceutical agents (both diagnostic and therapeutic) may be derived by chemically bonding a pharmaceutical agent to a photographic coupler molecule, which can be precipitated as micro-nanoparticles with Z-average particle diameter to as small as 10 nm by homogeneous nucleation and precipitation in the presence of surface active surface modifiers, and that such particles are stable and do not appreciably flocculate or aggregate due to interparticle attraction forces and can be formulated into pharmaceutical compositions exhibiting unexpectedly high bioavailibility. While the invention is described herein primarily in connection with its preferred utility, i.e., with respect to nanoparticulate substances for use in pharmaceutical compositions, it is also believed to be useful in other applications such as the formulation of particulate cosmetic compositions and the preparation of particulate dispersions for use in image and magnetic recording elements. The particles preferred by this invention comprise a pharmaceutical agent substance by chemically bonding them to a photographic coupler molecule. The invention can be practiced with a wide variety of pharmaceutical agent substances. The said agent substance preferably is present in an essentially pure form. The agent substance must be poorly soluble and dispersible in at least one liquid medium. By "poorly soluble" it is meant that the said substance has a solubility in the liquid dispersion medium of less than about 10 mg/mL, and preferably of less than about 1 mg/mL. A preferred liquid dispersion medium is water. However, the invention can be practiced with other liquid media in which a pharmaceutical agent is poorly soluble and dispersible including, for example, aqueous salt solutions, safflower oil, and solvents such as ethanol, t-butanol, hexane, and glycol. The pH of the aqueous dispersion media can be adjusted by techniques known in the art. Suitable pharmaceutically useful chemical compositions (PUCC) can be selected from a variety of known classes of drugs including, for example, analgesics, anti-inflammatory agents, anthelmintics, anti-arrhythmic agents, antibiotics (including penicillins), anticoagulants, antidepressants, antidiabetic agents, antiepileptics, antihistamines, antihypertensive agents, antimuscarinic agents, antimycobacterial agents, antineioplastic agents, immunosuppressants, antithyroid agents, antiviral agents, anxiolytic sedatives (hypnotics and neuroleptics), astringents, beta-adrenoceptor blocking agents, blood products and substitutes, cardiac inotropic agents, contrast media, corticosteroids, cough suppressants (expectorants and mucolytics), diagnostic agents, diagnostic imaging agents, diuretics, dopaminerigics (antiparkinsonian agents), haemostatics, immuriological agents, lipid regulating agents, muscle relaxants, parasympathomimetics, parathyroid calcitonin and biphosphonates, prostaglandins, radio-pharmaceuticals, sex hormones (including steroids), anti-allergic agents, stimulants and anoretics, sympathomimetics, thyroid agents, vasodilators and xanthines. Preferred drug substances include those intended for oral administration and intravenous administration. A description of these classes of PUCC and a listing of species within each class can be found in Martindale, The Extra Pharmacopoeia, Twenty-ninth Edition, The Pharmaceutical Press, London, 1989, the disclosure of which is hereby incorporated by reference in its entirety. The drug substances are commercially available and/or can be prepared by techniques known in the art. Representative illustrative species of substances useful as diagonostic agents are X-ray contrast agents that can act as suitable pharmaceutically useful compositions (PUCC) are as follows: ##STR2## In the above structures, R can be OR', OH, or ##STR3## wherein R' is alkyl, and R 2 and R 3 are independently H or alkyl. Each alkyl group can independently contain from 1-20, preferably 1-8, and more preferably, 1-4 carbon atoms. The alkylene group preferably contains from 1-4 carbons atoms such as methylene, ethylene, propylene and the like, optionally substituted with for example an alkyl group, such as methyl and ethyl. Particularly preferred contrast agents include the ethyl ester of diatrizonic acid, i.e., ethyl-3,5-diacetamido-2,4,6-triiodobenzoate, also known as ethyl-3,5-bis(acetylamino)-2,4,6-triodobenzoate or tehyl diatrizoate, having the structural formula A above wherein R=--OCH 2 CH 3 the ethyl glycolate ester of diatrizoic acid, i.e., ethyl(3,5-bis(acetylamino)-2,4,6-triiodobenzoyloxy)acetate, also known as ethyl diatrizoxyacetate, having the structural formula A above wherein ##STR4## and ethyl-2-(3,5-bis(acetylamino)-2,4,6-triiodobenzoyloxy)butyrate, also known as ethyl-2-diatrizoxybutyrate, having the structural formula A above wherein ##STR5## In addition, it is expected that the invention can be practiced in conjunction with the water insoluble iodinated carbonate esters described in PCT/EP90/00053. The above described X-ray contrast agents are known compounds and/or can be prepared by techniques known in the art. For example, water-insoluble esters and terminal amides of acids such as the above-described iodinated aromatic acids can be prepared by conventional alkylation or amidation techniques known in the art. The above-noted acids and other acids which can be used as starting materials are commercially available and/or can be prepared by techniques known in the art. The examples which follow contain illustrative examples of known synthetic techniques. It is to be noted that agents (therapeutic or diagnostic) that are suitable for this invention must be soluble but remain relatively unhydrolyzed in aqueous alkaline solutions. Compounds described in U.S. Pat. Nos. 5,264,610, 5,260,478 (Bacon) and (application) PRF-469/92 (Bacon, et al.) that are unhydrolyzable in aqueous alkaline solutions are also included herein by reference as agents suitable for the practice of this invention. The X-ray contrast agent can be an iodinated compound. The iodinated compound can be aromatic or nonaromatic. Aromatic compounds are preferred. The iodinated compound can comprise one, two, three, or more iodine atoms per molecule. Preferred species contain at least two, and more preferably, at least three iodine atoms per molecule. The iodinated compounds selected can contain substituents that do not impart solubility to the compound, such as, for example, alkylureido, alkoxyacylamido, hydroxyacetamido, butyrolactamido, succinimido, trifluoroacetamido, carboxy, carboxamido, hydroxy, alkoxy, acylamino, and the like substituents. A preferred class of contrast agents includes various esters and amides of iodinated aromatic acids. The esters preferably are alkyl or substituted alkyl esters. The amides can be primary or secondary amides, preferably alkyl or substituted alkyl amides. For example, the contrast agent can be an ester or amide of a substituted triiodobenzoic acid such as an acyl, carbamyl, and/or acylmethyl substituted triiodobenzoic acid. Illustrative representative examples of iodinated aromatic acids include, but are not limited to, diatrizoic acid, metrizoic, iothalamic acid, trimesic acid, ioxaglic acid (hexabrix), ioxitalamic acid, tetraiodoterephthalic acid, iodipamide and the like. It is contemplated that poorly soluble derivatives of iodamide and iopyrol can be used herein. The invention can also be practiced with poorly soluble derivatives, e.g., ester and ether derivatives, of hydroxylated nonionic X-ray contrast agents. Illustrative nonionic contrast agents include, but are not limited to, metrizamide; ioglunide; iopamidol; iopromide; iogulamide; iohexol, and other compounds described in U.S. Pat. No. 4,250,113; ioversol, and other compounds described in U.S. Pat. No. 4,396,598; nonionic triiodinated compounds, such as described in Investigative Radiology, Vol. 19, July-August 1984; and nonionic dimers, such as described in Radiology, 142: 115-118, January 1982. The invention can be practiced with poorly soluble derivatives of iodomethane sulfonamides, iodinated aromatic glucoanilides, 2-ketogulonamides, reversed amides, peptides, carbamates, esters, glycoside and glucose derivatives, benzamide derivatives, isophthalamides, bis compounds, and bis-polyhydroxylated acylamides, such as described in Volume 73 of the Handbook of Experimental Pharmacology, entitled Radiocontrast Agents, edited by M. Sovak, 1984, Springer-Verlag, Berlin, pages 56-73. Many of the iodinated molecules described above, if in monomeric form, can also be prepared as dimers (sometimes referred to as bis compounds), trimers (sometimes referred to as tris compounds), etc., by techniques known in the art. It is contemplated that this invention can be practiced with poorly soluble-iodinated compounds in monomeric, dimeric, trimeric and polymeric forms. Representative illustrative compounds are described by Sovak, cited above, pages 40-53. Other examples of diagnostic PUCC are fluorescent molecules, dyes, radioactive atoms and electronic spin labeled compounds. The coupler moiety in the PCMPA could be any photographic coupler including dye-forming couplers, colored couplers, development inhibitor release coupler or development inhibitor anchimeric release couplers as disclosed in "The Theory of the Photographic Processes", 4ed, by T. H. James, Macmillan, New York, 1977; "Photographic Silver Halide Emulsions, Preparations, Addenda, Systems, and Processing", Research Disclosure 36544, September 1994, p. 501, disclosed anonymously; "Small Format Film", Research Disclosure 36230, January 1994, p. 317, disclosed anonymously; "Typical and Preferred Color Paper, Color Negative, and Color Reversal Photographic Elements and Processing", unpublished EK Docket #71,600 by J. Pawlak et al., are included herein by reference. To illustrate typical PCMPA some of their structures are listed in the following: ##STR6## wherein ballast is a chemical group, ring on chain which renders desired solubility criterion to the PCMPA, typical "links" are ##STR7## where, ballast is the same as before and COG is a leaving group such as substituted phenol or nitrogen hetorocycle. ##STR8## where R 1 , R 2 , can be Cl,--OCH 3 , --SO 2 NH--CH 3 , --CO 2 CH 3 ,H etc., and "link" is --CONH-- or --SO 2 NH-- ##STR9## where X is --O-- or --NH-- and "link" is a chain or a ring. ##STR10## where "link" is a phenyl ring. ##STR11## where R 1 may be CH 3 or t-butyl and R 2 is a long chain alkyl group ##STR12## where "link" is a substituted phenyl ring. ##STR13## where "link" if a substituted phenyl ring. ##STR14## wherein COG═H or a leaving group such as substituted phenol. Specific examples of photographic coupler modified pharmaceutical agents (PCMPA) given below are diagnostic X-ray contrast agents. ##STR15## In this work we have used compound 1 as the example to illustrate this invention and its utility. The photographic coupler and pharmaceutical agent are linked by suitable chemical moieties as described earlier. The non-toxic solvent which is miscible with the liquid medium can be methanol, ethanol, n-propanol, isopropanol, acetone, etc. By miscible with the liquid medium is meant that they are miscible at all proportions. In a preferred embodiment, the above procedure is followed with step 4 which comprises removing the formed salts and solvent by diafiltration or dialysis. This is done in the case of dialysis by conventional dialysis equipment known in the art. By diafiltration by conventional diafiltration equipment known in the art. Preferably, the final step is concentration to a desired concentration of the agent dispersion. This is done by conventional diafiltration equipment known in the art. The second step of this invention comprises adding an aqueous solution of a surface modifier to be adsorbed on the surface of the pharmaceutical agent. Useful surface modifiers are believed to include those which physically adhere to the surface of the drug substance but do not chemically bond to the pharmaceutical agent. Suitable surface modifiers (the term "surface modifiers" is used interchangeably with "surfactants") can preferably be selected from known organic and inorganic pharmaceutical excipients. Such excipients include various polymers, low molecular weight oligomers, natural products and surfactants. Preferred surface modifiers include nonionic and anionic surfactants. Representative examples of excipients include gelatin, casein, lecithin (phosphatides), gum acacia, cholesterol, tragacanth, stearic acid, benzalkonium chloride, calcium stearate, glyceryl monostearate, cetostearl alcohol, cetomacrogol emulsifying wax, sorbitan esters, polyoxyethylene alkyl ethers, e.g., ethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, e.g., the commercially available Tweens, polyethylene glycols, polyoxyethylene stearates, colloidal silicon dioxide, phosphates, sodium dodecylsulfate, carboxymethylcellulose calcium, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose phthalate, non-crystalline cellulose, magnesium aluminum silicate, triethanolamine, polyvinyl alcohol, and polyvinylpyrrolidone (PVP). Most of these excipients are described in detail in the Handbook of Pharmaceutical Excipients, published jointly by the American Pharmaceutical Association and The Pharmaceutical Society of Great Britain, the Pharmaceutical Press, 1986, the disclosure of which is hereby incorporated by reference in its entirety. The surface modifiers are commercially available and/or can be prepared by techniques known in the art. Particularly preferred surface modifiers include polyvinyl pyrrolidone, Pluronic F68 and F108, which are block copolymers of ethylene oxide and propylene oxide, Tetronic 908, which is a tetrafunctional block copolymer derived from sequential addition of ethylene oxide and propylene oxide to ethylenediamine, dextran, lecithin, Aerosol OT, which is a dioctyl ester of sodium sulfosuccinic acid, available from American Cyanamid, Duponol P, which is a sodium lauryl sulfate, available from DuPont, Triton X-200, which is an alkyl aryl polyether sulfonate, available from Rohm and Haas, Tween 80, which is a polyoxyethylene sorbitan fatty acid ester, available from JCI Specialty Chemicals, and Carbowax 3350 and 934, which are polyethylene glycols available from Union Carbide. Surface modifiers which have found to be particularly useful include polyvinylpyrrolidone, Pluronic F-68, and lecithin. The surface modifier is adsorbed on the surface of the pharmaceutical agent in an amount sufficient to maintain an average particle size of less than about 100 nm. The surface modifier does not chemically react with the drug substance or itself. Furthermore, the individually adsorbed molecules of the surface modifier are essentially free of intermolecular crosslinkages. When particle size is measured by photon correlation spectroscopy (PCS) the average particle size is the Z-average particle diameter, known to those skilled in the art. In some preferred embodiments of the invention, the Z-average particle diameter of less than about 50 nm. In some embodiments of the invention, the Z-average particle diameter is of less than about 10 nm. Additional surface modifier may be added to the dispersion after precipitation. Thereafter, the dispersion can be mixed, e.g., by shaking vigorously. Optionally, the dispersion can be subjected to a sonication step, e.g., using an ultrasonic power supply. For example, the dispersion can be subjected to ultrasonic energy having a frequency of 20-80 kHz for a time of about 1 to 120 seconds. The relative amount of agent substance and surface modifier can vary widely and the optimal amount of the surface modifier can depend, for example, upon the particular agent substance and surface modifier selected, the critical micelle concentration of the surface modifier if it forms micelles, etc. The surface modifier preferably is present in an amount of about 0.1-10 mg per square meter surface area of the drug substance. The surface modifier can be present in an amount of 0.1-90%, preferably 2-60% by weight based on the total weight of the dry particle. The resulting dispersion of this invention is stable and consists of the liquid dispersion medium and the above-described particles. The dispersion of surface modified pharmaceutical agent micro-nanoparticles can be spray-coated onto sugar spheres or onto a pharmaceutical excipient in a fluid-bed spray coater by techniques well-known in the art. Pharmaceutical compositions according to this invention include the particles described above and a pharmaceutically acceptable carrier therefore. Suitable pharmaceutically acceptable carriers are well-known to those skilled in the art. These include non-toxic physiologically acceptable carriers, adjuvants or vehicles for parenteral injection, for oral administration in solid or liquid form, for rectal administration, and the like. A method of treating a mammal in accordance with this invention comprises the step of administering to the mammal in need of treatment an effective amount of the above-described pharmaceutical composition. The selected dosage level of the agent substance for treatment is effective to obtain a desired therapeutic response for a particular composition and method of administration. The selected dosage level therefore, depends upon the particular drug substance, the desired therapeutic effect, on the route of administration, on the desired duration of treatment and other factors. As noted, it is a particularly advantageous feature that the pharmaceutical compositions of this invention exhibit unexpectedly high bioavailability as illustrated in the examples which follow. Furthermore, it is contemplated that the drug particles of this invention provide more rapid onset of drug action and decreased gastrointestinal irritancy. It is contemplated that the pharmaceutical compositions of this invention will be particularly useful in oral and parenteral, including intravenous, administration applications. It is expected that poorly water soluble drug substances, which prior to this invention, could not have been administered intravenously, may be administered safely in accordance with this invention. Additionally, drug substances which could not have been administered orally due to poor bioavailability may be effectively administered in accordance with this invention. While the applicants do not wish to be bound by theoretical mechanisms, it is believed that the surface modifier hinders the flocculation and/or agglomeration of the particles by functioning as a mechanical or steric barrier between the particles, minimizing the close, interparticle approach necessary for agglomeration and flocculation. Alternatively, if the surface modifier has ionic groups, stabilization by electrostatic repulsion may result. It was surprising that stable drug particles of such a small effective average particle size and free of unacceptable contamination could be prepared by the method of this invention. Methods of Performing the Invention The process of this invention involves a method of preparing stable dispersions of pharmaceutical agents (therapeutic or diagnostic) in the presence of a surface modifying and colloid stability-enhancing surface active agent free of trace any toxic solvents or solubilized heavy metal impurities by the following procedural steps. 1. Dissolving the said drug a pharmaceutical agent in aqueous base and a non toxic water miscible solvent with stirring and heat and then cooling the solution to room temperature, 2. Adding above #1 formulation, with stirring, to a surface active surfactant (or surface modifier) solution to form a clear solution and, 3. Neutralizing above formulation, with stirring, #2 with an appropriate acid solution and optionally, 4. Removal of salts and solvent by dialysis or diafiltration, 5. Concentration of dispersion by conventional means. The process of this invention is illustrated in FIG. 1. The process of this invention produces dispersion of photographic agent with Z-average particle size, less than 100 nm in diameter as measured by PCS that are stable in particle size upon keeping under room temperature or refrigerated conditions. Such dispersions also demonstrate limited particle size growth upon autoclave decontamination conditions used for standard blood-pool pharmaceutical agents. Preferred Z-average particle size of the micro-nanoparticle of this invention is less than 50 nm by PCS. Further preferred Z-average particle size of the invention may be less than 10 nm by PCS. This invention can also be performed in semicontinuous, continuous, or continuous batch methods. Such methods provide numerous advantages over prior processes of forming dispersions of pharmaceutical agents. The invention provides continuous or semicontinuous methods in which the particle size of the formed dispersions will be reproducible from run to run. Shutdowns of the system can be accomplished with minimum waste or growth of particle size. These and other advantages of the invention will become apparent from the detailed description below. The schematic of FIG. 2 illustrates apparatus 80 for performing the process of the invention. The apparatus is provided with high purity water delivery lines 12. Tank 14 contains a solution 11 of surfactant and high purity water. Jacket 15 on tank 14 regulates the temperature of the tank. Surfactant enters the tank through line 16. Tank 18 contains a pharmaceutical agent solution 19. Jacket 17 controls the temperature of materials in tank 18. The tank 18 contains a port for delivery of the pharmaceutical agent and water miscible solvent entering through manhole 20, a base material such as aqueous sodium hydroxide solution entering through line 22. The solution is maintained under agitation by the mixer 26. Tank 81 contains acid solution 25 such as propionic acid solution entering through line 30. The tank 81 is provided with a heat jacket 28 to control the temperature, although with the acids normally used, it is not necessary. In operation, the acid solution is fed from tank 81 through line 32 to mixer 34 via the metering pump 86 and flow meter 88. A pH sensor 40 senses the acidity of the dispersion as it leaves mixer 34 and allows the operator to adjust the acid pump 86 to maintain the proper pH in the dispersion exiting the mixer 34. The pharmaceutical agent 19 passes through line 42, metering pump 36, flow meter 38, and joins the surfactant solution in tank 14. In tank 14, the alkaline pharmaceutical agent is mixed with the surfactant solution and is pumped using pump 29 and flow meter 31 into the mixing chamber 34. The particles are formed in mixer 34 and exit through pipe 48 into the ultrafiltration tank 82. In the preferred process, tank 82, the dispersion 51 is held while it is washed by ultrafiltration membrane 54 to remove the salt from solution and adjust the material to the proper water content for makeup at the proper concentration. The source of high purity water is purifier 56. Agitator 13 agitates the surfactant solution in tank 14. Agitator 27 agitates the acid solution in tank 81. The generated salts are removed during the ultrafiltration process through permeate (filtrate) stream 58. In some instances, the suitable surface modifier is the surface active agent in an ester that may be base hydrolyzable. An example of such surfactant is Aerosol A102 or Aerosol A103, manufactured by American Cyanamid. ##STR16## During small-scale laboratory precipitation scheme described in FIG. 1, preparation time is short enough such that hydrolysis of the surfactant in alkaline solution is virtually undetectable. However, during manufacturing, mixing and holding time could extend to 1-2 hours. In such case, hydrolysis of the surfactant is substantial and needs to be eliminated by reducing the contact time of the surfactant with the alkali. To accomplish this, the following manufacturing schemes are adopted. In the following embodiment of the invention, the alkaline pharmaceutical agent solution is mixed with the surfactant solution continuously and neutralized within less than a second of mixing in a continuous reactor with acid solution to eliminate surfactant hydrolysis. The schematic of FIG. 3 illustrates apparatus 10 for performing the process of the invention. The apparatus is provided with high purity water delivery lines 12. Tank 14 contains a solution 11 of surfactant and high purity water. Jacket 15 on tank 14 regulates the temperature of the tank. Surfactant enters the tank through line 16. Tank 18 contains a pharmaceutical agent solution 19. Jacket 17 controls the temperature of materials in tank 18. The tank 18 contains a port for delivery of the pharmaceutical agent and water miscible solvent entering through manhole 20, a base material such as aqueous sodium hydroxide solution entering through line 22. The solution is maintained under agitation by the mixer 26. Tank 81 contains acid solution 25 such as propionic acid entering through line 30. The tank 81 is provided with a heat jacket 28 to control the temperature, although with the acids normally used, it is not necessary. In operation, the acid is fed from tank 81 through line 32 to mixer 34 via the metering pump 86 and flow meter 88. A pH sensor 40 senses the acidity of the dispersion as it leaves mixer 34 and allows the operator to adjust the acid pump 86 to maintain the proper pH in the dispersion exiting the mixer 34. The pharmaceutical agent 19 passes through line 42, metering pump 36, flow meter 38, and joins the surfactant solution in line 44 at the T fitting 46. The particles are formed in mixer 34 and exit through pipe 48 into the ultrafiltration tank 82. In tank 82, the dispersion 51 is held while it is washed by ultrafiltration membrane 54 to remove the salt from solution and adjust the material to the proper water content for makeup at the proper concentration. The source of high purity water is purifier 56. Agitator 13 agitates the surfactant solution in tank 14. Agitator 27 agitates the acid solution in tank 81. The generated salts are removed during the ultrafiltration process through permeate (filtrate) stream 58. In some cases, the alkaline pharmaceutical agent, the surfactant solution, and the acid solution may be directly and continuously mixed in the continuous mixer to obtain nanoparticulate dispersions. In such a case, the following manufacturing scheme is adopted. The apparatus 70 schematically illustrated in FIG. 4 is similar to that illustrated in FIG. 3 except that the acid solution in pipe 32, the surfactant solution in pipe 44, and the pharmaceutical agent solution in pipe 42 are directly led to mixing device 34. Corresponding items in FIG. 3 and FIG. 4 have the same numbers. In this system, all mixing takes place in the mixer 34 rather than joining of the surfactant solution and the pharmaceutical agent solution in the T connection immediately prior to the mixer as in the FIG. 3 process. The previously described methods of this invention find their most preferred use in large-scale production such as in a continuous commercial process. However, preparation of dispersions in pH-controlled conditions can also be practiced on a smaller and/or slower scale in a semicontinuous or continuous manner. The devices of FIGS. 5 and 6 illustrate equipment that is in accordance with the invention for smaller scale production. The device of FIG. 5 was designed for continuous pH-controlled precipitation of dispersions. The apparatus 90 of FIG. 5 provides a continuous means for precipitation of nanoparticulate dispersions. Container 92 is provided with an aqueous surfactant solution 94. Container 96 is provided with an acid solution. Container 100 contains a basic solution 102 of the pharmaceutical agent water containing a water miscible solvent. Container 104 provides a mixing and reacting chamber where the dispersion formation takes place. Container 106 is a collector for the dispersed suspensions 158. In operation, the surfactant solution 94 is metered by pump 108 through line 110 into the reactor vessel 104. At the same time, the basic pharmaceutical agent solution is metered by pump 112 through line 114 into the reactor 104 at a constant predetermined rate. The solutions are agitated by stirrer 116, and acid 98 is metered by pump 118 through line 121 into the reactor 104 to neutralize the solution. The pumping by metering pump 118 is regulated by controller 120. Controller 120 is provided with a pH sensor 122 that senses the pH of the dispersion 124 in reactor 104 and controls the amount and the rate of the addition of acid 98 added by pump 118 to neutralize the content of the reaction chamber. The drive for stirrer 116 is 126. The recorder 130 constantly records the pH of the solution to provide a history of the dispersion 124. Metering pump 132 withdraws the dispersion solution from reactor 104 and delivers it to the container 106 using pump 132 and line 150 where it may exit from the outlet 134. In a typical precipitation, there is a basic pharmaceutical agent solution 102, sodium hydroxide solution, and the surfactant. The surfactant is in water, and the neutralizing acid is an aqueous solution of acetic or propionic acid. The reaction chamber has a capacity of about 800 mL. Pharmaceutical agent solution tank 100 has a capacity of about 2500 mL. The surfactant solution tank 92 has a capacity of about 5000 mL. The acid solution tank has a capacity of about 2500 mL, and the dispersion collection tank has a capacity of about 10,000 mL. The temperature is controlled by placing the four containers 92, 96, 104, and 100 in a bath 136 of water 138 whose temperature can be regulated to its temperature up to 100° C. Usually, precipitation is carried out at 25° C. The temperature of the bath 138 is controlled by a steam and cold water mixer (not shown). The temperature probe 140 is to sense the temperature of the reactor. This is necessary for correct pH reading. The neutralization of the basic pharmaceutical agent solution in the reaction chamber 104 by the proportionally controlled pump 118 which pumps in acid solution 98 results in control of pH throughout the run to ±0.2 of the set pH value which is usually about 6.0. FIG. 6 schematically illustrates a semicontinuous system for forming nanoparticulate dispersions of pharmaceutical materials. Identical items are labeled the same as in FIG. 5. Because of reduced scale, the sizes of acid kettle 96 and the pharmaceutical agent kettle 100 are smaller (about 800 mL each). In the system of FIG. 6, the reactor 104 is initially provided with an aqueous surfactant solution. In this is pumped a basic solution of photographic agent 102 through pipe 114. 112 is a pH sensor that, working through controller 120, activates pump 118 to neutralize the dispersion to a pH of about 6 by pumping acetic acid 98 through metering pump 118 and line 121 to the reactor 104. Reactor 104 must be removed, dumped, and refilled with the aqueous surfactant solution in order to start a subsequent run. The base used to solubilize the photographic agent could be any strong alkali as NH 4 OH, NaOH, KOH, LiOH, RbOH, or CsOH, or organic bases as amines such as trialkyl amines or pyridine, etc. The acids used for neutralization in this invention preferably could be any weak acids such as formic, acetic, propionic, butyric acids, etc., or in some cases, mineral acids such as HCl, H 2 SO 4 , HNO 3 , HClO 4 , may be preferred. Typical water miscible solvents of this invention are CH 3 --OH, C 2 H 5 --OH, butanol, isobutanol, propanol, isopropanol, acetone, etc. Other modifications of this invention could be performed according to the processes described in other patents of Bagchi, et al., such as U.S. Pat. Nos. 4,933,270; 4,970,131; 4,900,431; 5,013,640; 5,089,380; 5,091,296; 5,104,776; 5,135,884; 5,158,863; 5,182,189; 5,185,230; 5,264,317; 5,279,931; 5,358,831 and are hereby incorporated herein by reference. Another preferred modification of the precipitation device of this equipment, 700, of this invention is shown in FIG. 7. FIG. 7 schematically depicts a batch system for precipitating crystalline nanoparticulate pharmaceutical agent suspensions. The reactor 701 is initially provided with an aqueous solution of surfactant, or a surface modifier and pH buffer. The reactor is equipped with a magnetic stirring bar 702, a temperature probe 703, and a pH sensor 704. The revolutions of the magnetic stirring bar are maintained at a medium-high level, as controlled by a magnetic plate regulator 705. A strongly basic, particle-free aqueous solution (containing a water miscible solvent) of the pharmaceutical agent is delivered by a pump, 706, with a flow rate control, via tubing 707, to the reactor. Simultaneously, an aqueous acid solution is delivered to the reactor by a pump 708 with a flow rate control via tubing 709. The flow rate of both streams, their concentration, and the duration of their subsurface delivery are carefully selected in such a manner that the final pH is restricted between 3.0 and 7.0, and the final concentration of the suspension is between 0.5% to 10%. Containers 710 and 711 hold the pharmaceutical agent solution and acid solution, respectively. In another preferred embodiment of the invention continuous precipitation may be carried out in a tubular reactor 800 of FIG. 8. The neutralization reaction takes place in a tubular reactor, which consists of a tubing or pipe 801 equipped with a static mixer 802. The inlet section of the tubular reactor allows for an influx of three streams through three connectors 803, 804, and 805. Initially, the tubular reactor is supplied with a stream of an aqueous carrier solution of surfactant and pH adjusting buffer, by a pump 806, with a flow rate control, via tubing 807, and the connector 803. A strongly basic, particle-free aqueous solution (containing water miscible solvent) of the pharmaceutical agent is delivered by a pump 808 with a flow rate control, via tubing 809 and the connector 804, to the tubular reactor. Simultaneously, an aqueous acid solution is delivered to the reactor by a pump with a flow rate control 810, via tubing 811 and the connector 805. The flow rate of the influx streams and their concentration are selected in such a manner that the final DH is less than 7.0, and preferably is between 3.0 and 7.0, and the final concentration of the suspension is between 0.5% to 10%. Containers 812, 813, 814, and 815 hold carrier solution, pharmaceutical agent solution, acid solution, and the product suspension, respectively. The total length of the tubular reactor is such that the reaction is completed before the suspension reaches the outlet of the reactor, at the flow rates of the influx streams and the diameter of the reactor used. In an alternate embodiment of the above apparatus, only two inlet streams are simultaneously delivered to the tubular reactor. The connector 803 is plugged off, and the pump 806 is not shut off. Since the carrier solution is not used, the aggregate volumetric flow rate of the two reactant streams is higher than that typically employed in the three-stream configuration described above. The invention is illustrated in the following examples. EXAMPLES Example 1 Synthetic Preparation of PCMPA #1 ##STR17## A mixture of 50 g (0.075 moles) of sulfonyl chloride i and 29 g (0.059 moles) of ii were stirred in 250 mLs of dry pyridine overnight at room temperature. The reaction solution was then added to 1000 mL of ice water containing 250 mLs of concentrated HCl. The mixture was extracted with ethyl acetate. The ethyl acetate layer was separated, washed with 10% HCl, brine and dried over MgSO 4 . The solution was filtered through a small plug of SiO 2 and stripped to an oil in vacuo. The oil was dissolved in 160 mLs of warm ether followed by 500 mLs of 30°-60° ligroine. Stirring overnight and filtering gave 62 g of a white solid. This solid was slurried with 500 mL of hot methanol. After cooling to room temperature and stirring overnight, filtering gave 43.8 g of white solid. Finally, the material was recrystallized from 200 mLs of toluene and 100 mls of heptane. After collection and drying in vacuo at 40°, there was obtained 40.8 or 62.3% of the desired product. m.p. 172°-173° m.s. m + at m/e 1100 1 HNMR in CDCl 3 consistant HPLC 99.3% CHN theo 46.93, 4.38, 2.55 found 46.64, 4.22, 2.49 Example 2 Preparation of Micro-Nanoparticulate Dispersions of PCMPA #1 Micro-nanoparticulate dispersion of PCMPA #1 was prepared by the method of this invention as follows: ______________________________________Agent Solution______________________________________PCMPA #1 -5 gn-propanol -5 g20% NaOH (aqueous) -1 g______________________________________ The above mixture was heated to 55° C. to dissolve then cooled to room temperature. ______________________________________Surfactant Solution______________________________________Distilled Water -125 gAerosol A012 33% in water (BASF) -45 g______________________________________ The agent solution was added to the surfactant solution and then immediately neutralized with 15 g of 15% propronic acid. The formed dispersion was dialyzed against distilled water for 24 h and then concentrated by hanging the dialysis bag in a well ventilated hood for 4 days. Resultant dispersions was analyzed for PCMPA #1 concentration by HPLC and was found to be 11.3%. A particle size distribution of the dispersion as measured by PCS is shown in FIG. 10. It is seen that 90% of the particles are between 8 and 15 nm in diameter. The Z-average particle size of the dispersion was 12 nm. Even though there are a very few particles at the tail end of the distribution of 50 nm in diameter such particles are indeed very small and are expected to provide very high bioavailability. FIG. 9 shows a cyro transmission electron photomicrograph of the dispersion of this example. Example 3 Preparation of Micro-Nanoparticulate Dispersion of PCMPA #1 Micro-nanoparticulate dispersion of PCMPA #1 was prepared by the method of this invention as follows: ______________________________________Agent Solution______________________________________PCMPA #1 -20 gn-propanol -20 g20% NaOH (aqueous) -5 g______________________________________ The above mixture was heated to 55° C. to dissolve then cooled to room temperature. ______________________________________Surfactant Solution______________________________________Distilled Water -500 gAerosol A012 33% in water (BASF) -14.3 g______________________________________ Polystep B23 nC.sub.12 H.sub.25 --O--(CH.sub.2 --CH.sub.2 --O).sub.12 --SO.sub.3.sup.-Na (Stephen Chemicals) The agent solution was added to the surfactant solution and then immediately neutralized with 60 g of 15% propronic acid solution to form the micro-nanoparticulate pharmaceutical agent dispersion. The formed dispersion was continuously dialyzed against distilled water for 24 h and then concentrated by hanging the dispersion in the dialysis bag in a well ventilated hood for 7 days. The resultant dispersion was analyzed for PCMPA #1 concentration by HPLC and was found to be 14.2%. A cryo-transmission photoelectron micrograph of the dispersion particle is shown in FIG. 11. A PCS particle size distribution of the dispersion is shown in FIG. 12. In this distribution it is seen that 90% of particles lie between 7 and 12 nm with a Z-average particle size of 8 nm. From the micrograph of FIG. 10, it appears that the dispersion particles are fairly uniform, although very few particle as large as 35 nm diameter is observed. Example 4 Lymphographic Imaging Using Micro-Nanoparticulate Dispersion of Example 2 A suspension prepared as described in Example 2 was used to image the lymph system (approximately 3 Kg rabbits) by computed tomography (CT). The suspension was dosed by percutaneous administration via the foot pads of the rabbits at 0.03 mL/Kg animal body weight and imaged 9 hours after administration. The CT images demonstrated enhanced X-ray contrast of the lymph nodes responsible for clearance from the anatomical areas of the rabbit injected with this formulation. Enhanced density was observed for times as long as 1 week after which the X-ray density of the lymph nodes returned to normal levels. The invention has been described in detail with reference to preferred embodiments thereof, but it will be understood that various variations and modifications can be effected within the spirit and scope of the invention.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] This invention relates to a system for delivering bioactive materials, and, more particularly, to a water soluble matrix of polyvinylpyrrolidone (PVP) and copolymers thereof, and an anionic surfactant, in the form of a complex, for solubilizing the bioactive material, as a nanoparticle dispersion, at reduced levels of surfactant. [0003] 2. Description of the Prior Art [0004] D. Childers et al, in U.S. Pat. No. 6,413,921, described an antimicrobial composition containing parachlorometaxylenol (PCMX) as antimicrobial in an anionic surfactant composition comprising a mixture of surfactants including a surfactant having a hydrophobic portion, a sarcosine surfactant, and a foaming anionic surfactant such as sodium lauryl sulfate. The antimicrobial composition was used for disinfection of a skin surface in preparation for surgery. SUMMARY OF THE INVENTION [0005] What is described herein is a delivery system for bioactive materials which includes a water soluble matrix of polyvinyl pyrrolidone (PVP) polymer, or copolymers thereof, and an anionic surfactant, in the form of a complex. The delivery system of the invention is a water soluble nanoparticulate dispersion/microemulsion of the bioactive material in the defined matrix. A typical delivery system includes triclosan as antibacterial in a mouthwash formulation, a toothpaste, a shampoo, or in a drug tablet. [0006] A use composition of the invention is for water purification, cleaning composition or for wound dressing. [0007] A typical formulation comprises, by weight, a water clear composition of 3% triclosan, 3% PVP K-30 and 10.5% sodium dodecylsulfate (SDS). A feature of this invention is that the polymer and surfactant forms a complex which can solubilize the bioactive material in water even below the critical micellular concentration (cmc) of the surfactant itself. DETAILED DESCRIPTION OF THE INVENTION [0008] Suitable bioactive materials include triclosan, chlorhexidine, iodopropargyl butyl carbamate (IPBC), orthophenyl phenol, parachlorometaxylenol (PCMX), parachloro ortho benzyl phenol, tertiary amyl phenol, pine oil, mixed phenol disinfectants, mixed phenol and quats. [0009] Suitable water soluble polymers for forming the polymer-surfactant complex in the matrix of the invention includes PVP, alkylated PVP copolymers, PVA-vinyl acetate copolymers, and the like. [0010] Suitable anionic sulfactants include sulfonic acid derivatives, such as sodium dodecyl sulfate, laureth sulfate, alkyl sulfonate, sarcosinate, alkyl phosphate ester, and the like. [0011] The presence of the water soluble PVP polymer in the matrix is essential for forming a polymer-surfactant complex which can dissolve the bioactive material even with low amounts of surfactant present in the composition. Both the use of a low level of anionic surfactant and the complexing polymer like PVP provides a substantially irritant-free composition. [0012] The amount of SDS to solubilize the active in water depends on the active to be solubilized and concentration of the active ingredient. The higher the active ingredient concentration, the higher the amount of SDS to be added. [0013] For compositions of the polymer-surfactant-complex and hydrophobic bioactive materials the weight ratio of bioactive material to polymer suitably is 1:5 to 5:0.5, preferably 1:0.2 to 1:2. The weight ratio of bioactive material to surfactant suitably is 1:10 to 2:1, preferably 1:3 to 1:5. The use level of bioactive suitably is 10 ppm to 10%, preferably 100 ppm to 5%, and most preferably 0.05% to 0.2%. The rest is water. Example 1 [0014] 3% Triclosan was dissolved in water containing, by weight, 3% polyvinylpyrrolidone (PVP K-30) and 10% sodium dodecyl sulfate (SDS). The aqueous concentrate was diluted at 1/10, 1/30, 1/60, and 1/120 to produce optically clear, ready-to-use disinfectant compositions. Triclosan in these compositions were in the nano-particle range. [0015] Compositions with lower than 10% SDS or with 10% SDS in the absence of PVP did not dissolve the triclosan. Example 2 [0016] A use formulation containing, by weight, 3% triclosan, 3% PVP K-30 and 10.5% SDS was diluted with water at a weight ratio of 1/450 to a final concentration of 66 ppm triclosan, 66 ppm PVP K-30 and 230 ppm SDS. The diluted sample remained clear without any precipitate. While the amount of SDS at this dilution is below the cmc of SDS itself, it was above the critical aggregation concentration of an insitu formed PVP-SDS complex. Thus, the disinfectant active triclosan ingredients were maintained soluble in water at this low surfactant content because it was present in the polymer-surfactant complex. Example 3 [0017] 5.4% 2-phenylphenol was dissolved in water containing, by weight, 2.3% PVP K-30 and 16.6% SDS. The aqueous concentrate was diluted at 3.6/100 and 1.9/100 to produce optically clear, ready-to-use disinfectant compositions. 2-phenylphenol in these compositions was in the nanoparticle range. Example 4 [0018] 4.2% Triclosan was dissolved in water containing, by weight, 3.2% PVP K-30 and 17% SDS. The aqueous concentrate was diluted at 4.6/100 and 2.3/100 to produce optically clear, ready-to-use disinfectant compositions. Triclosan in these compositions was in the nanoparticle range. Example 5 [0019] 2% Triclosan was dissolved in water containing, by weight, 2% PVP K-30 and 7% SDS. The optically clear aqueous concentrate was diluted at 1/10 and 1/20 to produce optically clear, ready-to-use disinfectant compositions. Triclosan in these compositions was in the nanoparticle range. Example 6 [0020] 2% Triclosan was added to water containing, by weight, 2% PVP K-30. Triclosan remained undissolved in the aqueous concentrate. Example 7 [0021] 2% Triclosan was added to water containing, by weight, 7% SDS. The sample was heated to 60° C. for 3 days. Triclosan remained undissolved in the aqueous concentrate. Example 8 [0022] 1% Ferulic acid was dissolved in water containing, by weight, 2.8% PVP K-30 and 6.3% SDS. The aqueous solution was optically clear and in the nanoparticle range. Example 9 [0023] 5.4% PCMX was dissolved in water containing, by weight, 16.5% SDS and 2.3% PVP K-30. The aqueous concentrate was diluted at 1/10, 1/20, 1/40, 1/100, and 1/450 to produce optically clear, ready-to-use disinfectant compositions. PCMX in these compositions was found to be in nanoparticle range. Example 10 [0024] 2% PCMX was dissolved in water containing, by weight, 6% SDS and 1% PVP K-30. The aqueous concentrate was diluted at 1/10, 1/20 to produce optically clear, ready-to-use disinfectant compositions. PCMX in these compositions was found to be in nanoparticle range. Biological Activity [0025] The formulation described in Example 10 was diluted in DI water to contain 1000 ppm of PCMX. Antimicrobial activity was demonostrated against Pseudomonas aeruginosa (ATCC 10145) and Bacillus subtilis (ATCC 27328). One hundred microliters of an overnight culture of each bacterial cell suspension were inoculated into the diluted sample to a final concentration of about 10 7 CFU/ml. The same bacterial suspension was also added to DI water to serve as a control. After 5 minutes incubation time at room temperature, the samples were serially diluted in Modified Letheen broth and plated onto modified Letheen Agar. Plates were incubated at 32° C. for 24 hours and bacterial growth enumerated. Log reduction was calculated based on the log difference in bacterial counts between the control sample (no PCMX) and PCMX containing sample. The results are presented in the following table. [0000] TABLE P. aeruginosa Log B. subtilis Log Treatment CFU/ml Reduction CFU/ml Reduction DI water 9.8 × 10 7 — 4.0 × 10 7 — 1000 ppm PCMX  <1 × 10 2 6 3.3 × 10 3 4 Example 11 [0026] 2% PCMX was added to water containing, by weight, 2% PVP K-30. PCMX remained undissolved in the aqueous concentrate. Example 12 [0027] 4.9% PCMX was dissolved in water containing, by weight, 13.8% SDS and 4% PVP K-30. This clear aqueous concentrate was diluted at 1/10, 1/20 to produce optically clear, ready-to-use disinfectant compositions at RT (18° C.). PCMX in these compositions was found to be in nanoparticle range. Example 13 [0028] 4.9% PCMX was added to water containing, by weight, 14.4% SDS. The sample was heated and cooled to RT (18° C.). PCMX remained undissolved in the aqueous concentrate. [0029] While the invention has been described with particular reference to certain embodiments thereof, it will be understood that changes and modifications may be made which are within the skill of the art.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The invention relates to an ophthalmoscope having a housing in which there are arranged an observing unit and an illuminating unit between which there are/is arranged diaphragm means and/or filter means that can be set via a swivel lever means mounted outside on the housing. [0003] 2. Description of the Background Art [0004] U.S. Pat. No. 4,684,227 discloses a generic binocular ophthalmoscope in whose lower housing part an observing unit is arranged by means of which an examiner can examine through a patient's pupil. An illuminating unit with a light source is accommodated in the upper housing part. An adjustable diaphragm is arranged between the light source and the observing unit. Also provided is a filter means by means of which optical filters can be moved into the illuminating path between the illuminating source and the observing unit. For the purpose of setting the diaphragm and the optical filters, there is respectively mounted on the side of the housing swivel lever means that comprises a rotary element, arranged in a bearing opening, on the outside of which a swivel lever is fastened. The swivel levers are kinematically connected to a mechanism for setting the diaphragm and/or the optical filters. [0005] The swivel lever means are mounted in a freely rotatable fashion in the bearing openings. As a rule, ophthalmoscopes are used by a single investigator who prefers a specific setting of the diaphragms and/or the optical filters. Other settings are carried out only rarely. Since the swivel lever means are supported in a freely rotatable fashion, the diaphragm or the optical filters are, however, displaced when the swivel levers are lightly touched, and this quickly comes about during improper handling. It is then necessary to reset the diaphragm and filters. SUMMARY OF THE INVENTION [0006] It is the object of the invention to provide a reliable handheld ophthalmoscope with the aid of simple design means. [0007] This object is achieved according to the invention by means of an ophthalmoscope comprising a housing in which an observing unit and a light source are arranged between which there is positioned at least one of diaphragm means and filter means that can be adjusted by swivel lever means mounted outside on said housing, wherein said swivel lever means can be locked in several locking positions by locking means. [0008] In the case of the ophthalmoscope according to the invention, the respective swivel lever means can be locked in respective latch stages by locking means. This prevents the setting of the diaphragm and/or the filters from being changed when the swivel lever means is inadvertently touched. An investigator can lock the diaphragm and the filters in a position he desires. [0009] It is advantageous for the locking means to be designed in such a way that it unlocks when a predetermined torque exerted on the swivel lever means is exceeded. This prevents the swivel lever means from being damaged when an excessive force is exerted on it. [0010] In a preferred embodiment of the ophthalmoscope according to the invention, the swivel lever means comprises a rotary element that is rotatably supported in a bearing opening provided in the housing. A number of latching depressions are formed in the edge of the bearing opening at an angular distance from one another. In order to lock the rotary element in a desired position, a latching slide provided on the rotary element can optionally be brought into engagement with one of the latching depressions. [0011] In this embodiment, the latching depressions and a tip of the latching slide have inclined sidewalls that bear against one another in the locking position of the latching slide. The inclination angle of the sidewalls in selected such that the latching slide moves out of the latching depression when a predetermined torque is applied to the rotary element, such that damage to the swivel lever means during application of an excessively large force is prevented. DETAILED DESCRIPTION OF THE DRAWINGS [0012] An exemplary embodiment of the invention is explained in more detail below with the aid of drawings, in which: [0013] FIG. 1 shows an ophthalmoscope in a perspective fashion, [0014] FIG. 2 shows a cross section through the upper part of the ophthalmoscope of FIG. 1 , [0015] FIG. 3 shows a perspective longitudinal view of a swivel lever means of the ophthalmoscope of FIG. 1 , [0016] FIG. 4 shows a schematic of the engagement of a latching slide of the locking means of FIG. 3 in latching depressions, [0017] FIG. 5 shows a perspective illustration of the swivel lever means of FIG. 3 , and [0018] FIG. 6 shows a sectional side view of the swivel lever means of FIG. 3 . DETAILED DESCRIPTION OF THE INVENTION [0019] As shown in FIG. 1 , the ophthalmoscope 10 according to the invention comprises a lower housing part 14 in which an observing unit is arranged behind a central glass pane 42 . The observing direction of the observing unit can be set by a setting rod 26 . [0020] Provided above the glass pane 24 is an upper housing part 12 in which an illuminating unit with an illuminating source, for example LEDs, is accommodated. Although it is not shown in the drawings for reasons of clarity, in the case of the ophthalmoscope according to the invention, as in the case of the opthalmoscope known from U.S. Pat. No. 4,684,227, there is firstly arranged between the light source and the observing unit an adjustable diaphragm means, after which there is arranged a filter means with optical filters in the illuminating path. The diaphragm means can be set by a swivel lever means 16 via a mechanism that is not shown. The setting of the filters is enabled by a swivel lever means 17 via a mechanism (likewise not shown). [0021] Two swivel lever means 16 , 17 are of identical design. For this reason, the construction of the swivel lever means 16 , 17 is described with the aid of the swivel lever means 16 for the diaphragm means. A circular bearing opening 32 is provided in the corresponding sidewall 28 of the top housing part 12 . An overall cylindrical bearing section 34 of a rotary element 33 is rotatably supported in the bearing opening 32 . By means of a coaxial screw 36 , the bearing section 34 is connected inside in a rotationally fixed fashion to the diaphragm means in order to adjust it. [0022] Guided in the bearing section 34 such that it can be displaced in the radial direction of the bearing section 34 is a locking body 40 of a locking element 41 that extends beyond the outside of the bearing section 34 and has on its outside a fluted gripping surface 42 . [0023] Upwardly extending outside the upper housing part 12 from the bearing section 34 is a lever 38 that has in the region of the locking body 40 a downwardly extending shoulder 46 that, in the unlocking position, shown in FIG. 2 , of the locking body 40 , engages in a recess 44 on the top side of the locking body 40 , and bears against the base thereof. [0024] Extending radially downward approximately from the axis of rotation of the bearing section 34 at a distance from the vertically running inside of the locking body 40 is a narrow latching slide 52 designed integrally with the locking body 40 . There is formed as a result between the locking body 40 and latching slide 52 a downwardly open U-shaped cutout 48 that extends radially downward and extends longitudinally. The latching slide 52 is guided radially at the side in a slot 59 in the bearing section 34 . [0025] As is to be seen in FIG. 4 , there are formed in the edge 35 of the bearing opening 32 a number of latching depressions 54 a , 54 b , 54 c , 54 d that are open toward the axis of rotation and outwardly and have sidewalls 64 , 66 that are inclined to the radial of the bearing opening 32 through the middle of the corresponding latching depression 54 a , 54 b , 54 c , 54 d at an angle α, and are bounded by a tangentially running base 70 . At its tip, the latching slide 52 has lateral surfaces 62 , 68 that are inclined at the same angle as the lateral surfaces 64 , 66 of the latching depressions 54 a to 54 d. [0026] It is to be seen in FIG. 3 that a transversely running blind hole 37 in which a helical spring 39 is arranged is formed in the locking body 40 . It is shown in FIG. 6 , in which the locking body 40 is omitted for the purpose of clarity, that there is fastened at the end of the helical spring 39 a ball 43 which projects from the blind hole 37 in the unloaded state. Arranged at a distance from one another in the bearing section 34 in a fashion opposite the ball 43 are two substantially concave recesses 51 , 53 in the displacement direction of the locking body 40 , in which the ball 43 engages in the unlocking position or in the locking position of the locking body 40 . [0027] The ball 43 biased by the spring 39 ensures that the locking body 40 automatically latches in the unlocking position or in the locking position as soon as the ball 43 has overstepped the edge of the corresponding recess 51 , 53 . [0028] If the diaphragm is to be fixed in a specific position, for the purpose of locking the swivel lever means 16 the locking body 40 is displaced downward in the radial direction until the tip of the latching slide 52 strikes the base of the corresponding latching depression 54 a to 54 d , and the sidewalls 62 , 68 of the latching slide 52 bear against the sidewalls 64 , 66 of the corresponding depressions 54 a to 54 d . The swivel lever means 16 is thereby locked. As a result, an inadvertent misadjustment of the swivel lever means 16 , and thus of the diaphragm is prevented. The inclination of the lateral surfaces 62 , 64 , 66 , 68 , and the resistance of the locking body 40 in the radial direction are, however, selected such that in the event of a force that exceeds a previously determined force, the latching slide 52 is moved out of the corresponding latching depression 54 a or 54 d . This prevents damage to the swivel lever means 16 . The inclination angle α is a function of the coefficient of friction between the lateral surfaces 62 , 64 , 66 , 68 and the force that is required in order to move the locking body 40 in the unlocking direction. The angle α is preferably between 10 and 80 degrees. [0029] As the swivel lever means 17 is designed like the swivel lever means 16 , the filters can be fixed in the same way as described above.

1a

FIELD OF THE INVENTION [0001] The invention is directed to a new serine-threonine phosphatase protein of a parasitic organism of the Apicomplexa phylum and fragments thereof. More particularly, this invention is directed an active molecule capable of modulating the activity of such a protein. Furthermore, this invention is directed to uses of this protein for screening molecules capable of modulating the activity of a serine-threonine phosphatase protein of a parasitic organism of the Apicomplexa phylum, as well as for methods for preventing and treating parasitic infections. BACKGROUND OF THE INVENTION [0002] Protozoan parasites such as Plasmodium falciparum and Toxoplasma gondii belong to the phylum of Apicomplexa and the class of Coccidia. [0003] Coccidia are among the most important parasites of animals parasites and some are human pathogens of major medical importance: the causative agent of malaria, Plasmodium falciparum , causes death of more than two million children every year while other Apicomplexa such as Toxoplasma gondii and to a lesser extent Cryptosporidium parvum are devastating human pathogens when they parasitize immunocompromised hosts. [0004] As to Toxoplasma gondii , following an asymptomatic parasitic process caused by the tachyzoite stage (replicative stage) but efficiently controlled by the host immune system, the parasite may persist as cryptic, <<dormant >> bradyzoite stage within intracellular cysts. These cysts resulting from host and parasite factors preferentially develop in muscle and brain tissues. Though the mechanisms by which cysts persist in the brain are not well defined yet, it is clear that the immune cells and their associated cytokine production play a major role. When this subtle immune interplay is disrupted as it occurs in AIDS patients, it induces cyst reactivation which is accompanied by the parasite differentiation from the slow growing bradyzoite stage into a highly replicative tachyzoite stage responsible for infiltrated <<inflammatory>> foci that leads to encephalitis. Currently existing chemotherapeutic treatments, while effective at controlling the parasite are poorly tolerated particularly by immunocompromised individuals. [0005] Toxoplasma infection may also be congenitally acquired. Such infection occurs only when a woman becomes primo-infected during pregnancy and severity of the disease may depend upon the stage of pregnancy at time of infection. Focal lesions develop in the placenta and the fetus may become infected. Apart from abortion, by far the most common sequel of congenital toxoplasmosis is ocular disease (blindness) but mental retardation is also quite common. [0006] As such the identification of molecules or molecular complexes of parasite origin and involved in the survival of the parasite should remain a research priority since it could lead to more targeted treatments. [0007] Certain developmental stages of these parasites including the sporozoites of Plasmodium, Cryptosporidium and Toxoplasma as well as the tachyzoites of Toxoplasma, move by a gliding motion across either a mucous layer or an extracellular matrix before encountering their host cells. They subsequently enter these cells by an active process and once in a suitable intracellular niche, they either multiply and/or differentiate, two steps required for parasite spreading before transmission to a new host. [0008] The strategies selected by these parasites for either gliding onto a substratum or for invading their host cells depend on the dynamics of their actin cytoskeleton. However, unlike during the crawling motility of higher eucaryotes, the remodeling of actin cytoskeleton remains discrete and speed values of gliding zoïtes are an order of magnitude faster than for most specialized crawling cells. In addition, host cell invasion occurs within few seconds. These peculiar features prompted us to search for molecules underlying the formation of the motile force in tachyzoïtes of Toxoplasma gondii . The inventors have recently identified Toxofilin, a novel actin binding protein, as the major candidate for controlling actin dynamics in tachyzoïtes. Toxofilin has been purified in complex with parasite actin monomers and in vitro assays have demonstrated it regulates the competence of actin monomers to associate and of polymers to elongate. When Toxofilin was ectopically overexpressed as GFP-tagged protein in mammalian non-muscle cells it clearly disrupted the actin cytoskeleton and caused disassembly of actin stress fibers. In tachyzoites, Toxofilin binds G-actin and copurifies with a parasite F-actin containing fraction suggesting that it may control parasite actin dynamics as well. Such a role was further suggested by the highly variable localization pattern of Toxofilin in the moving parasite i.e. during gliding or host cell entry (see Poupel et al., 2000. Molecular Biology of the Cell, vol 11, pp 355-368). SUMMARY OF THE INVENTION [0009] The inventors recently became interested in looking at Toxofilin phosphorylation since Toxofilin sequence displays several <<consensus sites>> for phosphorylation. The inventors have shown that Toxofilin is in vitro and in vivo phosphorylated: the parasite kinase activity which phosphorylates Toxofilin is cytosolic, is recovered after heparin sepharose chromatography and is inhibited by either soluble heparin, DRB, or GTP, three common inhibitors of casein kinase II (CKII). [0010] Investigating the phosphate turn over on Toxofilin, the inventors identified and biochemically characterized a type 2C phosphatase yet unidentified in T. gondii as a copurifying member of the G actin-Toxofilin complex. The inventors produced a recombinant PP2C which is a partial fragment of the PP2C protein and which contains 331 amino acids as well as a recombinant complete PP2C soluble and active on exogenous substrate (casein labeled with 32 P phosphate, see Materials and methods). Then, the inventors performed in vitro assays with this recombinant active PP2C and demonstrated that Toxofilin is a major substrate for type 2C phosphatase. [0011] The invention covers the complete PP2C and its fragments as well as the corresponding nucleotidic sequences. BRIEF DESCRIPTION OF THE DRAWINGS [0012] [0012]FIG. 1. FIG. 1 represents the nucleotidic sequence and the 331 amino acids sequence of Toxoplasma gondii type 2C phosphatase. [0013] [0013]FIG. 2. FIG. 2 represents in square brackets the portion of the amino acid sequence of FIG. 1 fused to glutathione S transferase corresponding to the partial recombinant protein obtained by the Inventors. [0014] [0014]FIG. 3A-H. FIG. 3A-H are an alignment of the PP2C amino acid sequences of Toxoplasma gondii and human genome (BLAST-plasmodatabase). This alignment shows that the catalytic site of each PP2C is conserved but that the remaining part of the sequences are different. [0015] [0015]FIG. 4. FIG. 4 represents a Western blot wherein PP 2 C proteins of P. falciparum and T. gondii are recognized by a polyclonal serum obtained after immunization of rabbit with a purified PP2C protein of T. gondii. [0016] [0016]FIG. 5A-B. FIGS. 5 A—Solubilization test of GST-PP2C (partial fragment). A SDS gel of a fused protein GST-PP2C (partial fragment) shows a specific band. FIG. 5B—Purification of the inclusion bodies. [0017] [0017]FIG. 6. Purification HTR-PP2C : SDS PAGE visualisation of eluates. [0018] For the purification process, E. coli bacteria (strain BL21) have been incubated with 0.1 mM IPTG to induce the GST-PP2C containing plasmid to be expressed (1 hour, 25° C.). After expression, the bacteria were lysed in PBS containing 0.5% vol/vol Triton X100 and 0.5% vol/vol SB 314 . With this lysis protocol, all the GST-PP2C remained in the insoluble fraction within the inclusion bodies. [0019] The inclusion bodies were then purified by successive centrifugation and recovered some GST-PP2C as seen in the photo of the SDS-PAGE electrophoresis. DESCRIPTION OF THE INVENTION [0020] One object of the invention is an active molecule capable of modulating the activity of a native protein of a parasitic organism of the Apicomplexa phylum, wherein said molecule is endowed with serine-threonine phosphatase activity, or a fragment thereof A fragment of said molecule is peptidic sequence capable of being recognized by a polyclonal serum obtained after immunization of a rabbit with a purified PP2C protein of T. gondii. [0021] In a preferred embodiment, the molecule endowed with serine-threonine phosphatase activity is a type 2C phosphatase (PP2C), and the parasitic organism of Apicomplexa phylum is selected from the group comprising Toxoplasma gondii, Plasmodium falciparum and Crystosporidium parvum. [0022] Another object of the invention is a molecule for preventing or treating an infection due to a parasitic organism of the Apicomplexa phylum wherein said molecule modulates the interaction between a protein of said parasitic organism endowed with serine-threonine phosphatase activity and Toxofilin of said parasitic organism. [0023] In a preferred embodiment, the protein of said parasitic organism endowed with serine-threonine phosphatase activity is a type 2C phosphatase (PP2C), and the parasitic organism of Apicomplexa phylum is selected from the group comprising Toxoplasma gondii, Plasmodium falciparum and Crystosporidium parvum. [0024] The protein of said parasitic organism has a nucleic acid sequence and an amino acid sequence with sufficient identity compared to the sequence of FIG. 1 for being endowed with serine-threonine phosphatase activity. The active site corresponding to the enzymatic activity is located from amino acid 18 to amino acid 325 (included). The molecular weight is 37 kDa. [0025] Another object of the invention is a method for screening molecules capable of modulating the activity of a native protein of a parasitic organism of the Apicomplexa phylum endowed with serine-threonine phosphatase activity wherein said method comprises the steps of: [0026] a) possibly fixing a native or a recombinant Toxofilin of said parasitic organism to a matrix; [0027] b) phosphorylating said Toxofilin with labeled ATP using a parasite kinase fraction or a recombinant casein kinase II; [0028] c) controlling the phosphorylation of Toxofilin by labeling counting; [0029] d) incubating the labeled Toxofilin with or without the molecule to be tested and adding a native or a recombinant serine-threonine phosphatase of said parasitic organism; [0030] e) measuring the labeling; [0031] wherein a variation of the labeling of the Toxofilin incubated with the molecule to be tested compared with the labeling of the Toxofilin incubated without the molecule to be tested is indicative of the capacity of the molecule to modulate said serine-threonine phosphatase activity of said protein. [0032] In a preferred embodiment, the protein of said parasitic organism endowed with serine-threonine phosphatase activity is a type 2C phosphatase (PP2C), and the parasitic organism of Apicomplexa phylum is selected from the group comprising Toxoplasma gondii, Plasmodium falciparum and Crystosporidium parvum. [0033] An other object of the invention in a molecule capable of modulating the activity of a native protein of a parasitic organism of the Apicomplexa phylum endowed with serine-threonine phosphatase activity which is capable to be screened by said method. [0034] Another object of the invention is a method for screening molecules for preventing or treating an infection due to a parasitic organism of the Apicomplexa phylum wherein said method comprises the steps of: [0035] f) possibly fixing a native or a recombinant Toxofilin of said parasitic organism to a matrix; [0036] g) phosphorylating said Toxofilin with labeled ATP using a parasite kinase fraction or a recombinant casein kinase II; [0037] h) controlling the phosphorylation of Toxofilin by labeling counting; [0038] i) incubating the labeled Toxofilin with or without the molecule to be tested and adding a native or a recombinant serine-threonine phosphatase of said parasitic organism; [0039] j) measuring the labeling; [0040] wherein a decrease of the labeling of the Toxofilin incubated with the molecule to be tested compared with the labeling of the Toxofilin incubated without the molecule to be tested is indicative of the capacity of the molecule to prevent or treat an infection due to a parasitic organism of the Apicomplexa phylum. [0041] In a preferred embodiment, the protein of said parasitic organism endowed with serine-threonine phosphatase activity is a type 2C phosphatase (PP2C), and the parasitic organism of Apicomplexa phylum is selected from the group comprising Toxoplasma gondii, Plasmodium falciparum and Crystosporidium parvum. [0042] Another object of the invention is an active molecule for preventing or treating an infection due to a parasitic organism of the Apicomplexa phylum which is capable to be screened by said method. [0043] Another object of the invention is an antibody directed against a native protein of a parasitic organism of the Apicomplexa phylum, said protein being endowed with serine-threonine phosphatase activity. [0044] Another object of the invention is a method for preventing or treating an infection due to a parasite of the Apicomplexa phylum wherein said method comprise administration of a molecule of the invention. EXAMPLES [0045] In vivo 32 P Orthophosphate Labeling of Tachyzoïte and Toxofilin Immunoprecipitation [0046] Purified transiently extracellular parasites were rinsed in phosphate and serum-free buffer (10 mM Tris-Cl pH 7.4, 150 mM NaCl, 5 mM KCl, 5 mM MgCl 2 , 1.6 mM CaCl 2 , 0.5% glucose, 0.1% bovine serum albumin) and incubated at 10 8 per ml in the same medium supplemented with 500 μCi per ml of orthophosphoric acid (specific activity of 8.8 10 9 Ci per mmole from NEN life Science products, Inc) (120 min, 37° C., 5% CO 2 ). Unincorporated radioactive phosphate was then washed out by rinsing three times the parasites in 50 ml of phosphate and serum-free buffer. 10 9 tachyzoïtes were lysed in 1 ml of [20 mM Tris-Cl pH 8.0, 50 mM KCl, 0.1 mM Ethyleneglycol-bis(β-aminoethyl)-N,N,N,N′-tetraacetic acid (EGTA), 0.1 mM Ethylenediamine-tetraacetic acid (EDTA)] supplemented with 0.5% (vol/vol) protease inhibitor stocks by 5 liquid nitrogen freezing and defreezing cycles. Lysates were centrifuged (10 min, 800×g, 4° C.) and the corresponding supernatants were first clarified (20 min, 20.000×g, 4° C.), then precleared on sepharose CL-4B (Pharmacia) (1 hour, 4° C.). After removal of the sepharose-bound protein fractions, the soluble fractions were successively incubated with Toxofilin antibodies (overnight, 4° C.) and with protein G-sepharose (1 hour, 23° C.). After successive washes in buffer A (50 mM Tris-HCl, pH 7.5, 150 mM NaCl) supplemented with 0.1% vol/vol TX-100 and 0.5% (wt/vol) serum albumin then supplemented only with 0.1% vol/vol TX-100 and a final wash in buffer A, the protein G-sepharose bound fraction was eluated in SDS-PAGE sample buffer. Eluates were boiled prior to a 12% acrylamide gel electrophoresis and radioactive scan of the dried gel. [0047] Production of rToxofiline [0048] The inventors used the expression vector pGEX6-P3 (Pharmacia) into which the full length Toxofilin encoding cDNA was cloned as described in Poupel et al (2000) but to improve the yield of Toxofilin production, the protocol was slightly modified as follows. An E. coli clone (BL21 strain) positive for the plasmid was grown up to OD=1.2-1.4 and induced with isopropylthio-β-D-galactoside (0.1 mM, 1 hour, 25° C.). At the end of the induction period the bacteria were pelleted and subsequently lysed in buffer PBS- and sonicated (30 seconds, 4° C.). The lysate was supplemented with TX-100 (0.5% vol/vol) and N-tetradecyl-N,N-dimethyl-3 ammonio-1-propanesulfonate (0.5% wt/vol, Sigma) (15 min, 4° C.). The supernatant recovered after centrifugation (15.000×g, 15 min, 4° C.) was incubated with sepharose CL-4B (1 hour, 4° C.) and the unbound fraction was incubated with glutathione sepharose (Pharmacia) (4° C., overnight). The beads were washed with 30 bead volumes of PBS-containing 0.1% TX-100 and with 10 volumes of prescission cleavage buffer (50 mM Tris-HCl, pH 7.0, 150 mM NaCl, 1 mM EDTA, 1 mM dithiothreitol (DTT)). The bound GST-polypeptide was cleaved with pre-scission protease to recover the recombinant Toxofilin (r-Toxofilin) without GST (Pharmacia) (8 hours, 4° C.). Soluble r-Toxofilin was immunoprecipitated with anti-Toxofilin antibodies (overnight, 4° C.) and recovered on protein G-dynabeads (1 hour, 23° C.) (Dynal) before the kinase/phosphatase assay. [0049] Identification and Cloning of T. gondii Type 2C Phosphatase (TgPP2C) [0050] Native gel and Peptide microsequencing: The native gel was performed as described in Poupel et al. (2000). The gel slice containing the 36 kDa actin-binding protein from the parasite was subjected to tryptic digestion (30° C., 18 hours, 0.3 mg of trypsin in 0.1 M TrisHCl, pH 8.6; 0.01% (vol/vol) Tween 20). The tryptic peptides were recovered by HPLC on a DEAE and a C18 columns. The sequencing of two peptides gave respectively SVFDGTVGDFAQENV and NQSADNITAMTVFFK and the latter was found in one clone from the T. gondii database of expressed sequence tags (EST, WashU-Merk Toxoplasma EST project). [0051] cDNA library screening and DNA sequencing: Non-degenerate primers were synthesized for amplification of the target sequence from the clone identified as TgESTzy48A06.R1. The oligonucleotide with the sequence: 5′-AGTGCAGACAACATTACTGCGATG-3′ corresponding to part of one peptide microsequence (SADNITAM) was used as the up stream primer, while 5′-AGACACACCAAGAATCTCGTC-3′ was chosen as the down stream primer in the TgEST clone. The PCR conditions for amplification of the 207 bp DNA product were as follows: a hot start of 2 min at 94° C. followed by 35 cycles (45 sec, 94° C.; 30 sec, 53° C.; 30 sec, 72° C.) and a final elongation step at 72° C. for 10 min. The 207 bp fragment recovered was 32 P-labeled using random priming (Megaprime kit, Amersham), purified on Sephacryl S-400 HR column (Pharmacia) and used as a probe to screen a T. gondii tachyzoite cDNA library (kindly provided by J. W. Ajioka, Cambridge, UK). After 2 rounds of screening, 12 independent overlapping clones were selected and their cDNA was prepared for nucleotide sequencing performed by Genset (France), using both vector and T. gondii sequence specific primers (Genset). [0052] Biochemical Characterization of TgPP2C Activity [0053] Phosphatase assays were carried out using 10 μM 32 P-casein. Briefly, the reaction mixture in a total of 30 μl, consisted of 10 μl containing 100 ng protein of tachyzoïte cytosolic fraction (in 10 mM Tris-Cl pH 8.0, 150 mM NaCl, 0.1% vol/vol of protease inhibitors, 4° C.) plus 10 μl of phosphatase assay buffer (50 mM Tris-Cl pH 7.4, 0.5% β-mercaptoethanol, 0.1% BSA) containing the different effectors. 10 μl of labeled substrate ( 32 P-casein) was added to start the reactions (30 min, 30° C.) and 200 μl of 20% trichloracetic acid to stop them. The mixtures were centrifuged (5 min, 15.000×g) and 180 μl of the supernatant was directly counted for 32 P radioactivity using a Cerenkov counter. [0054] Production of a Thioredoxin-Hispatch Tg PP2C and Biochemical Characterization [0055] The fragment for expression of TgPP2C was prepared by PCR amplification of a full length TgPP2C encoding cDNA, using primers introducing a EcoRI restriction site at position 5′ and a XbaI restriction site at position 3′. For amplification of the upper strand: 5′-GCCGAATTCCCATGAAGTCCTCTGCTGAAATTAG-3′ and of the lower strand: 5′-GCCTCTAGACTAATCAGTCTTCTTGAAGAACACTG-3′. The amplified fragment was cloned into the expression vector pThioHis B (Invitrogen) after digestion with EcoRI and XbaI of both fragment and vector. For expression of the ThioHis-TgPP2C, an E. coli clone (Top10 strain) positive for the plasmid was grown up to OD=0.8 and induced with isopropylthio-β-D-galactoside (0.1 mM, 2 hours, 37° C.). At the end of the induction period, the bacteria were pelleted and subsequently lysed in buffer (20 mM NaH 2 PO 4 , 500 mM NaCl, N-octylglucoside (0.5% vol/vol) supplemented with 0.1% (vol/vol) protease inhibitor stocks by sonication (30 seconds, 4° C.) and one liquid nitrogen freezing and defreezing step (10 min, 4° C.). DNase was added to 2 μg/ml (30 min, 4° C.) followed by centrifugation (10 min, 14.000×g, 4° C.). The supernatant was chromatographied on a nickel column (Probond, Invitrogen) and the imidazole eluate was dialyzed before being chromatographied on a phenylarsineoxide-agarose column (Thiobond, Invitrogen). Mercaptoethanol eluates were dialyzed against 5 mM Tris-HCl, pH 7.5, 50 mM NaCl and stored aliquoted in 5% sucrose at 80° C. until use for testing the activity (see above). [0056] Tachyzoïte Cytosol Preparation and Heparin Chromatography [0057] Cytosol: Frozen tachyzoites (10 9 ) were thawed on ice and lysed by 5 liquid nitrogen freezing and defreezing cycles in 500 μl of kinase buffer (10 mM Tris-HCl, pH 7.5, 150 mM NaCl, 10 mM MgCl 2 , 1 mM DTT) supplemented with 0.2% (vol/vol) protease inhibitor stocks. The extract was centrifuged (15 min, 800×g, 4° C.) to remove nuclei and unbroken cells. The supernatant was centrifuged (30 min, 100.000×g, 4° C.) in a TL100 table top ultracentrifuge (Beckman) using the TLA 100.3 rotor. The resulting cytosol was stored frozen at −80° C. in 100 μl aliquots until use. [0058] Heparin chromatography: A cytosolic fraction from 10 9 parasites was pre-cleared on sepharose CL-4B (1 hour, 4° C.), and subsequently chromatographied on heparin sepharose (Pharmacia) (1 hour, 4° C.). After several washes in 10 mM Tris-HCl, pH 7.5, 150 mM NaCl supplemented with 0.5% vol/vol TX-100, the heparin-bound proteins were recovered by a 0.5 M NaCl elution in 10 mM Tris-HCl, pH 7.5. The eluate was dialyzed against kinase buffer (overnight, 4° C.) prior to be used in kinase assay while the heparin unbound fraction (i.e.: flow through) was thoroughly recovered and stored at −80° C. Each lot was controlled for its activity on casein (see above). [0059] Kinase and Phosphatase Assay on Toxofilin [0060] Kinase reaction: 2 μg of immobilized rToxofilin on protein G-dynabeads were washed in kinase buffer before to be incubated with a tachyzoïte cytosolic fraction prepared in kinase buffer (μg of proteins in 100 μl) and precleared on protein G-dynabeads. The reaction was started by adding 100 μM of Na 2 ATP and 10 μCi of [γ 32 P] ATP (3000 Ci/mmol, NEN life science product, Inc) (15 min, 30° C.). Unbound materials and unincorporated [γ 32 P] ATP were washed out with 200 volumes of kinase buffer containing with TX-100 (0.5% vol/vol) followed by 100 volumes of kinase buffer. Toxofilin and bound proteins were eluted in SDS-PAGE sample buffer prior to electrophoresis and radioactivity scan (phosphoimager, Molecular Dynamics). Toxofilin phosphorylation was quantified using NIH Image Quant software. [0061] To characterize the kinase activity responsible for Toxofilin phosphorylation, three types of experiments were carried out: [0062] 1) Pharmacological inhibitors such as heparin (20 μg per ml, Sigma), GTP (200 μM, Sigma), 5,6-dichloro-1-B-D-ribofuranosylbenzimidazole (100 μM, Calbiochem) or staurosporine (1 μM, Calbiochem) were added 15 min before starting the kinase reaction. [0063] 2) A fraction eluted after heparin chromatography of the cytosol and the corresponding unbound fraction (see above) were assayed for their respective kinase activity towards rToxofilin. [0064] Phosphatase reaction: The purified recombinant TgPP2C dialyzed against kinase buffer was added (doses activité) either before to start the kinase assay or after the last wash in kinase buffer. In the latter case, control and test samples were incubated for 15 additional minutes (30° C.) before a final wash in kinase buffer. In some control experiments, one unit of a recombinant fragment of rabbit catalytic type 1 phosphatase (Up State Biotechnology) which is known to dephosphorylate several T. gondii tachyzoïte proteins was replacing TgPP2C. Eluates were treated as described for the kinase assay. [0065] Tg PP2C Antibodies [0066] A rabbit polyclonal antibody raised against the GST-partial PP2C was prepared and absorbed on GST to get only the PP2C reactive immunoglobulins. It has been initially raised using GST-partial PP2C separated in a polyacrylamide gel slice directly injected to rabbits (according to standard protocol of EUROGENTEC, 4 immunizations on day 0, 14, 28 and 56). Each immunization performed with a composition containing from 20 to 100 μg of PP2C which is a polypeptide comprising 265 amino acids from V64 to K328 included as referred in FIG. 2. [0067] Protocol to Screen for PP2C Inhibitors [0068] It is possible to covalently fix the recombinant Toxofilin to a matrix (resin or membrane), to phosphorylate it with 32 P Adenosine Tri Phosphateusing either an enriched parasite kinase fraction which is already available or even a recombinant casein kinase II from other source (see Materiel and Methods). Human casein kinase II works well at phosphorylating Toxofilin. In addition, the Inventors are presently cloning the Toxoplasma casein kinase II. Once phosphorylation has been controlled by radioactive counting, it is easy to incubate the sample ( 32 P-labelled Toxofilin) with or without (control) putative inhibitors and add recombinant PP2C. The criteria to analyze will be the radioactive counts and to observe if those counts have or have not decreased. An efficient phosphatase hydrolyses the 32 P phosphate which is then lost in the washes and consequently induces a decrease in radio-active counts. If the phosphatase activity is blocked by an inhibitor (either towards the catalytic site or affecting the 3D structure of the catalytic site), the 32 P phosphate will not be hydrolyzed. Such assay also allows quantitative analysis of the inhibitory effect towards the phosphatase activity. Some flurogenic substrates have been recently developed as an alternative to radio-activity for several phosphatase activity dosages. One might think about incorporating such fluorochrome to Toxofilin. Additionally, other substrate such as casein are commonly used to assay phosphatase activity including PP2C activity. [0069] Protocol to Screen for Inhibitors of the Host Cell Invasion by Toxoplasma gondii. [0070] One feature of Toxoplasma gondii tachyzoïte is that it can enter virtually any kind of cells, making in vitro invasion assay quite simple to realize. It is also feasible to incubate tachyzoïtes with orthophosphate (see Materials and Methods) and at the same time expose or not them to different putative inhibitors (different doses . . . ). [0071] In that case, it is possible to check if this/these inhibitor(s) affect the phosphorylation of Toxofilin (preparation of cytosol, immunoprecipitation of Toxofilin, electrophoresis and radioactive scanning to detect if Toxofilin has or not incorporated 32P). [0072] For invasion assay, the tachyzoïtes can be resuspended in 2 ml of Dulbecco's MEM (usually 5×10 7 ) supplemented with 2% of heat-inactivated foetal calf serum and expose to the putative inhibitors (different doses, duration . . . ) before being incubated with 70-80% confluent human foetal fibroblasts previously plated on glass coverslips (20 min, 37° C., 5% CO 2 ). It will be interesting to leave the inhibitor during the invasion assay (in case it is reversible) or to wash it off before the assay and finally to check any affect on the host cell. After a short contact between parasites and host cell (15 to 30 min), both will be fixed in 2% paraformaldehyde in PBS- (15 min, 23° C.). Extracellular parasites will be stained with a monoclonal anti-P30 surface protein of T. gondii (40 μg/ml, Euromedex) and revealed using the Alexa488 anti-mouse IgG conjugate (Molecular probes) while both internalized and extracellular parasite will be vizualized by 4′,6 Diamidino-2-phenylindole staining (DAPI, 5 μg/ml) under microscope. The number of cells containing parasites out of 100 cells randomly selected will be reported in triplicate for each treatment. In addition, for each coverslip, the number of internalized parasites per cell will be counted on 4 samples of 25 infected cells.

1a

TECHNICAL FIELD [0001] The present invention relates to efficiently storing cookware to optimize use of kitchen space. In particular, the present invention is directed to various types of magnetic cookware storage stands and devices. BACKGROUND OF THE INVENTION [0002] Cookware, such as pots and pans, often presents storage issues. Many people prefer not to store them in plain view within the kitchen, and thus they need to be stored in drawers, cabinets and the like. However, drawers and cabinets typically are not optimized for storage of pans and pots, especially those with a low depth and large diameter. Such cookware, akin to cutting boards and cooking utensils with large flat surfaces are often best stored with each pan oriented vertically. [0003] Additionally, it is important not to let other pans and utensils touch the interior of a given pan. First, it can scratch it, second, if there is a nonstick coating of any kind, such coating is often worn in places where other pans and utensils routinely rest on, or abut, such coated pans during storage. Wear and tear on non-stick coatings is known to introduce differential and non-uniform heating issues, and ultimately can destroy the cookware. These issues would similarly be remedied if cookware was stored so that it was oriented vertically. [0004] To store cookware vertically, the cookware must rest on its side. Unfortunately, pots and pans are not designed to rest on their sides. Often, exemplary pans have the shape of either wide and short cylinders, with a “deep dish” side structure, or are circular or oval shaped, and have sides that curve from a smaller bottom surface up to a larger area at the top of the pot or pan. These latter designs thus have two directions of curvature, both along and normal to the side of such cookware at any point. Thus, as a general rule, cookware has no stable flat surface except for its bottom surface on which they can conveniently be stored. Additionally, even if they could be stored on their sides in some semi-stable equilibrium, the typical long handle attached to them, as shown in FIGS. 1-3 , for example, tends to move around, and is not held in a fixed position. [0005] What is needed in the art are apparatus and methods to optimally store cookware so as to remedy the problems of the prior art. SUMMARY OF THE INVENTION [0006] In exemplary embodiments of the present invention various types of magnetic cookware stands are provided, allowing pots, pans and the like to be stored with their diametral dimension in a substantial vertical position, resting on a side. The cookware stands are provided with embedded magnets or magnetic devices, so as to either attach to a bottom surface of a pot or a pan, or to a handle of a pot or a pan. In some exemplary embodiments, a stand can be made up of various interconnected modular units, each unit able to hold one pan, and a user can configure how many of such units a desired cookware stand comprises (e.g., one or more). Such modular units are preferentially attached by means of embedded magnets or magnet devices The technology allows such pans to be conveniently stored, without resting upon, or even touching, one another. Because they can be oriented vertically in such exemplary devices, storage space is optimized. BRIEF DESCRIPTION OF THE DRAWINGS [0007] FIG. 1 illustrates an exemplary modular cookware stand with curved inner surface according to an exemplary embodiment of the present invention; [0008] FIG. 2 illustrates the exemplary cookware stand of FIG. 1 with a different surface veneer; [0009] FIG. 3 is a frontal view of the exemplary modular cookware stand of FIG. 1 showing two exemplary pans stored within it; [0010] FIG. 4 show right side and perspective frontal views of structural elements used in the exemplary modular cookware stand of FIG. 1 ; [0011] FIG. 5 shows various views of a single pan and its relationship to a single modular element of the exemplary modular cookware stand of FIG. 1 ; [0012] FIG. 6 show additional details of two modular elements of the exemplary cookware stand of FIG. 1 as connected; [0013] FIG. 7 show various renderings of modular elements, with detail of the bottom connection plates; [0014] FIG. 8 is a schematic drawing of the single modular element of FIG. 7( b ) in an exploded view; [0015] FIG. 9 is a schematic drawing of the rendering shown in FIG. 7 ; [0016] FIG. 10 shows an alternate exemplary embodiment of a magnetic cookware stand according to exemplary embodiments of the present invention; [0017] FIG. 11 show various views of the exemplary magnetic cookware stand of FIG. 10 ; and [0018] FIG. 12 shows various views of the exemplary magnetic cookware stand shown in FIG. 10 , without any pans so as to see structural details. [0019] FIG. 13 shows an embodiment adapted to hold a pan on each side of the vertical component. Also shown are magnetic attachments for attachment to further modules. [0020] FIG. 14 shows the attachment of two modular units of FIG. 13 . [0021] FIG. 15 shows an embodiment of a magnetic attachment for modular units of the invention in a first position. [0022] FIG. 16 shows an embodiment of a magnetic attachment for modular units of the invention in a second position. [0023] FIG. 17 shows an exploded view of an attachment means of an embodiment of the invention. [0024] FIG. 18 shows depicts the engagement of the spring and pin components of FIG. 17 . [0025] FIG. 19 depicts the external view of the engaged components of FIG. 17 . [0026] FIG. 20 depicts a slidable dowel connection of the present invention. [0027] It is noted that the patent or application file may contain at least one drawing executed in color. If that is the case, copies of this patent or patent application publication with color drawing(s) will be provided by the U.S. Patent and Trademark Office upon request and payment of the necessary fee. DETAILED DESCRIPTION OF THE INVENTION [0028] In accordance with exemplary embodiments of the present invention, apparatus can be provided to optimally store cookware, such as, for example, pots and pans. Such pots and pans can include any type, such as frying pans, sauté pans, saucepans and the like, of whatever type and description. A few examples of cookware that can be stored in exemplary storage stands according to the present invention are illustrated in FIGS. 1-3 , but are understood as being only exemplary. [0029] Modular Cookware Stand Attachable to Cookware Itself [0030] The figures, next described, illustrate exemplary magnetic cookware stands and attachment means according to exemplary embodiments of the present invention. In an exemplary embodiment any number of spaces or cells for pans to be stored can be created, given the modular nature of the exemplary cookware stand, as will be described more fully below. In addition, on one side of each cell, in the illustrated example it is the right side as one looks into the figures, a wall is provided or embedded with a number of magnets (at least one) such as, for example, anywhere from 2 to 4 or more. In the exemplary embodiment depicted in FIGS. 1 through 9 there are 4 magnets embedded in each right wall of each cell of the modular magnetic cookware stand. The magnetics depicted can be of varying sizes (e.g., round, oval square, rectangular, strips, etc.) The magnets can be aligned in any manner such as horizontally as depicted in FIG. 1 or vertically as depicted in FIG. 13 , the magnets can also be staggered in an arrangement to engage a pan. These magnets attract the bottom of a ferromagnetic pan which can be a pan made out of a single ferromagnetic material, or, for example, which can be a standard non-ferromagnetic pan, such as, for example aluminum or copper into which a steel or iron, for example, annular ring or plate, or central patch, has been embedded within the bottom surface, thus allowing it to easily be grasped by the embedded magnets. [0031] It is noted that such an embedded ferromagnetic surface should be large enough (either in width, length or diametral dimension, as the case may be) so that various pans of varying diameters can be readily stored in the magnetic cookware stand, and all be grasped by the embedded magnets. In exemplary embodiments of the present invention, an embedded ferromagnetic surface can be, for example, a sheet, annular ring or the like made of stainless steel, and glued, riveted or otherwise fastened to the bottom surface of cookware. For example, such a ferromagnetic surface can be an annular ring or circular shape embedded within the bottom surface of pots and pans, much like copper surfaces are embedded in certain cookware for heat transfer properties. The present invention is also directed to pans with non-ferromagnetic surfaces that have an embedded ferromagnetic material on the bottom surface or near the bottom surface (e.g., exposed or completely embedded) to engage a magnetic pan holder as disclosed herein. [0032] Beginning with reference to FIG. 1 , there is shown an exemplary modular cookware stand showing two full cells and one open cell at the far left. Thus, there is a space for 3 pans. As can be seen, the bottom surface of the pan is attached to magnets at the top right of the cell (as seen in the leftmost two empty cells—four silver dots at top of right wall). This allows the exemplary pan to be stored in an upright position, essentially resting on its side and having its long diametral dimension oriented in a vertical plane. This allows for optimization of storage in cabinets and drawers, such as are found in kitchens, and precludes having to stack pans one on top of the other which, as noted, can damage them and create a general lack of order in the pantry or cookware closet. In some embodiments as depicted in FIG. 1A , each single modular unit can hold a pan on each side of the vertical component. These units can also be attached to each other to hold multiple pans. [0033] FIG. 2 is an identical device as shown in FIG. 1 with a different outward veneer, but otherwise functionally the same. [0034] FIG. 3 shows the exemplary cookware stand of FIG. 1 from a head-on frontal view, holding two pans, one in each of the full cells. [0035] FIG. 4 show details of a modular element of the exemplary cookware stand. As noted, the exemplary cookware stand can be made as large or as small as desired, simply by adding modular structural elements. With reference to FIG. 4( a ) there is seen a back view of a modular element, and with reference to FIG. 4( b ), two such modular elements are combined to create a closed cell and an open cell. As can be seen in the figures, each modular element is a modified “L” shape, like a book-end, with a horizontal bottom surface and a vertical surface perpendicular to it. A curved transition is provided between the horizontal surface and the vertical one, whose radius of curvature is designed to match or approximate that of various sets of cookware. As also seen in FIG. 4( a ), there is an expandable connection plate provided on the underside of the modular element, explained in detail below in connection with FIGS. 6-9 . Alternatively, the modular units of FIG. 4 can be attached with embedded magnets as disclosed herein. In all of the modular embodiments disclosed herein, the present invention is also directed to a non-modular unitary pan holder that is adapted to hold a desired number of pans (etc., 2, 3, 4 or more) [0036] FIG. 5 shows a variety of views from all directions of an exemplary single pan in a single open modular cell according to an exemplary embodiment of the present invention. Thus, FIG. 5( a ) is a top view, and FIG. 5( b ) is a perspective left side view looking into the interior of the pan. FIG. 5( c ) is a rear view, FIG. 5( d ) a right side view without perspective, showing the exterior bottom surface of the pan. FIG. 5( e ) is a front view with the pan handle positioned at a 3 o'clock orientation, unlike the manner it would generally be stored, as is shown in FIG. 1 . Finally, FIG. 5( f ) is a bottom view showing the modular structural element and its bottom surface and showing the pan as oriented in it. [0037] FIG. 6 shows various views of a two modular element combination similar to that rendered in FIG. 4( b ). With reference to FIG. 6( a ), one can see that the movable metallic plate on the bottom of the structural element on the left has been pulled back so as to fit within a groove near the left edge, or leading edge, of the modular structural element on the right. This illustrates how respective modular structural elements are connected one to the other, and is explained in greater detail with reference to FIG. 7 below. FIG. 6( b ) shows the same structure as shown FIG. 6( a ) without the detail of the clasping mechanisms on the bottom. FIG. 6( c ) is a rear perspective view showing the clasping mechanism of the rightmost modular structural element being fully pushed in, as it is the end piece and is not being used to connect to, or to be inserted into a groove of an adjacent structural element. FIG. 6( d ) is a side perspective view similar to that of FIG. 6( a ). It is noted that in FIGS. 6( a ) and 6 ( d ) the groove in the leftmost element is empty, and the grove of the rightmost element is filled. Additionally, the clasping mechanism of the right most element is in its compressed or collapsed state. As disclosed herein, the attachment of modular units of the present invention can be by any means (e.g., with embedded magnets). [0038] FIG. 7 shows one embodiment of how the modular structural elements connect. FIGS. 7( a ) and 7 ( b ) are renderings of the objects shown schematically in FIGS. 6( a ) and 6 ( d ). As shown in FIG. 7( a ), the left most element has its slide pan, or clasping mechanism, slid backwards to its rear most position so that the vertical lip at the rear end of the slide pan can fit into a groove in the rightmost structural element. Also shown is the rightmost structural element with its slide pan fully extended rearward in a state that will allow it to connect to a third modular structural element to be placed to its right. FIG. 7( b ) shows a configuration of the last modular element in a chain, which will thus not connect to an additional structural element to its right and therefore its slide pan is closed and pushed to its foremost position, as shown. [0039] Finally, FIG. 8 is an exploded view of the modular structural element shown in FIG. 7( b ) showing the rivets inserted within an elongated oval hole (and then attached to the underside of the device) which thus allows the slide pan to slide rearward. As seen in FIG. 7( b ), the rivets can, for example, be inserted into the underside of the device in a line, at a distance from the left edge of the underside surface such that when closed, the slide pan fits precisely into a groove of the vertical right side of the modular element, and when fully open, the rivets keep the slide pan at the correct distance so that its rear lip fits precisely into the groove of the next structural element. [0040] Because all structural elements can be made identical as regards all dimensions except for the radius of curvature of the transition from horizontal to vertical, as described above (so as to accommodate various types and shapes of pans, if desired) the distance between the left end of the device and the groove, as well as the distance between the line containing the rivets and the groove of the next rightmost element, can all be fixed. [0041] FIG. 9 is a schematic drawing of the renderings of FIG. 7 and is otherwise identical in all functional respects. Cookware Stand Attachable to Handles—for Nonmagnetic Cookware [0042] Next described, with reference to FIGS. 10 through 12 is an alternate exemplary embodiment of a magnetic cookware stand according to the present invention. Similar to the structure of FIGS. 1 through 9 , this stand or pan holder can be modular or can be manufactured in either two cell, three cell, four cell, etc. versions that are not independently configurable by a user. As can be seen in FIG. 10 , this particular embodiment (as well as all other embodiments disclosed herein) may be made out of a transparent substance, such as, for example, plexiglass, acrylic, polycarbonate or some other transparent plastic, fiber or the like. In a particular embodiment, instead of having its bottom arranged so as to fit the contour of the bottom of a pan, the pan is not anticipated to rest within the bottom of the cell but rather to rest on a nearby surface such as, for example, the bottom surface of a drawer, pantry, cupboard, closet, etc. Thus, what holds the pans or other stored cookware in place is the set of magnets embedded on the upper right side of each cell which are designed to attach to a ferromagnetic handle in an otherwise non-ferromagnetic pan, as clearly seen for the open cell in FIG. 10 , and as seen on the leftmost outer surface. Therefore, cookware and pans which have no ferromagnetic components except for a small band on their handle, can be stored in the exemplary stand. Although in the illustrated embodiment, the embedded magnets are in one single line, at the same height, in exemplary embodiments of the present invention various rows or arrays of embedded magnets can be provided, so as to accommodate cookware of varying shapes, diameters and sizes. Also, the magnets can be embedded on both sides of the vertical component to have additional points of attachment for further pans. [0043] FIG. 11 shows a variety of views of the exemplary cookware stand of FIG. 10 , as next described. FIG. 11( a ) shows a top view of the pan being held with its handle at an approximate 3 o'clock position within one cell of an exemplary two cell stand. FIG. 11( b ) is a perspective left side view looking into the interior of the pan, and FIG. 11( c ) is a right side view showing the bottom surface of the pan. It is noted that in this exemplary embodiment as well, there is room for an additional pan at the left most end of the structure, as there are provided embedded magnets on the leftmost outer surface of the exemplary stand. Thus, actually three separate pans can be stored in the shown apparatus. Finally, FIG. 1 ( d ) is a pure front view of the view shown in FIG. 11( b ). [0044] FIG. 12 show additional details of the exemplary stand of FIGS. 10 and 11 without any pan to obscure the view. The device of FIG. 12( a ) is that of FIG. 10 rotated 180 degrees about the central column, such that the embedded magnets now appear on the left side of each cell. FIG. 12( a ) is a top view, and FIG. 12( b ) is a front view of the same device. FIG. 12( c ) is a right side view, showing the embedded magnets on the right most vertical upright. Finally, FIG. 12( d ) is a perspective front view of the exemplary structure. Thus, as in the case of the exemplary embodiment of FIGS. 1-3 , although there are only two full cells in this device, it can actually hold three pans because of the embedded magnets on the outside of the rightmost vertical upright of the device. As previously disclosed, this embodiment can also have additional magnets of the opposite sides of the vertical portions to hold additional pans. In certain embodiments, the space between the vertical components can be expanded to provide sufficient placement of multiple pans [0045] In exemplary embodiments of the present invention, there can be any array of magnets embedded in each side panel of the structure, or for example, a continuous bar magnet, or a magnetized plate, or the like. [0046] In general, it is noted, pans are not ferromagnetic, being often made of aluminum, or copper. Some pans, for example, made from stainless steel or cast iron, are ferromagnetic, and as a result they can be held in an exemplary cookware holder by the embedded magnets attaching to any portion of the bottom flat surface of the pan and not requiring being held in place by the pan handle, which is, in general, often the only ferromagnetic portion of the pan. [0047] In similar fashion as described above for adding ferromagnetic properties to the bottom surfaces of cookware, an analogous process can be performed for non-ferromagnetic cookware handles, thus facilitating the storage of such cookware in the exemplary cookware stand of the disclosed embodiments. In exemplary embodiments of the present invention, an embedded ferromagnetic surface can, for example, be embedded within, glued, riveted or otherwise fastened to a cookware handle, thus allowing it to attach to a magnet in a cookware stand. Such a surface can be, for example, a sheet or ring of stainless steel or other ferromagnetic material. [0048] FIG. 13 shows an alternative embodiment comprising a vertical component containing magnets for engaging a pan and at least one base extending perpendicular to stabilize the vertical component upright in position to engage one or more pans. In the depicted embodiment, there are two bases, one at the anterior of the vertical component and one at the posterior of the vertical component. In certain embodiments, the bases are positioned in an angular arrangement in order to engage the curvature of the pan and to support its weight, as not to have the magnets of the vertical component supporting the full weight of the engaged pan. In the depicted embodiment, in addition to magnets arranged to engage the pan, there are magnets embedded at the ends of the bases in order to engage further modular units in a linear arrangement. The magnets that are used in one modular unit can engage a magnet in another modular unit or can engage a non-magnetic metal surface or embedded metal material in another modular unit. The use of magnets as opposed to braces, clips, etc., facilitates the engagement and removal of modular units by the user. [0049] The magnetic connections can be either visible on the surface of the modular unit or embedded within the modular unit such that it is invisible. In some embodiments utilizing transparent materials, the magnetic connection can be fully embedded yet visible given the transparency of the base material. [0050] The magnetic connections can be incorporated into the modular units such that they are planar with the surrounding material. In other embodiments, the magnetic connections can be incorporated into the modular units such that one connection protrudes and engages with a cavity in another modular unit. The planar or protrusion embodiments can be present in both visible and invisible magnetic connection embodiments. [0051] The present invention is also directed to the magnetic connections disclosed herein without limitation to utilization with pan holders. The magnetic connections disclosed herein may be used to connect any two articles (e.g., modular kitchen organizers). [0052] In the depicted embodiment, the vertical component is trapezoidal. However, any geometric shape can be used to engage the pans. [0053] FIG. 14 depicts to engaged modular units as disclosed in FIG. 13 . In the depicted arrangement, two modular units allow for the engagement of four pans. [0054] One embodiment utilizes a magnetic connection which is a screw design. In the embodiment depicted in FIG. 15 , a casing (e.g., a cylinder with internal treads) is embedded into the modular unit. A magnetic material with external treads can engage the cylindrical base be in position to connect with another modular unit. The embodiment in FIG. 15 protrudes and may engage another unit with a cavity. In certain embodiments, the screw design magnet can engage another magnet or a non-magnetic material of another modular unit. [0055] FIG. 16 depicts an alternative embodiment of a screw design magnetic connection wherein the magnetic material is planar with the surface of the surrounding material. As with the screw design of FIG. 15 , a casing (e.g., a cylinder with internal treads) is embedded into the modular unit and a magnetic material with external treads engages the cylindrical base be in position to connect with another modular unit. In certain embodiments, the planar screw design magnet can engage another magnet or a non-magnetic material of another modular unit. [0056] In certain embodiments, the invention is directed to the screw design magnetic connections disclosed herein without limitation to the specific articles of manufacture that are attached. [0057] As depicted in FIG. 17 , the magnetic connection can be in the form of a spring loaded pin. In this embodiment, the pin with a magnetic head is engaged with a spring and held within a retaining vessel that is embedded in the module. In certain embodiments, the arrangement provides the magnetic connection with give to facilitate the attachment of the individual modules. In other embodiments, the spring loaded magnetic pin is in a first position to engage another module and snaps into a second position to disengage the modules. The spring and/or the retainer can be any suitable polymer or metal. FIG. 18 depicts the magnetic pin engaged with the spring. FIG. 19 depicts the spring loaded peg engaged with and planar to the retainer. [0058] The magnetic connection can also be in the form of a slidable dowel that is engaged in a retainer embedded in a module as depicted in FIG. 20 . At least the end of the dowel that faces outward is made of a magnetic material. The embedded end of the dowel and/or the retainer can be made of a self lubricating/low friction material (e.g., polypropylene or Deirin) to reduce jamming. In certain embodiments, the magnetic end of the dowel can be a protrusion to mate with a cavity of another module. In other embodiments, the magnetic end of the dowel is planar with the surface of the module. The dowel and/or the engaged surface of the other module can contain a magnetic surface. [0059] It is also noted that in order to allow a hot pan or article of cookware to be directly stored in the exemplary magnetic storage structures described above, a thin film or covering can be provided on top of the magnets (or other magnetic bar, plate, etc., as noted above) that are embedded in the storage structure, so as to thermally insulate the magnets from the heat of a hot pan, and thus insure that the magnets do not lose their magnetism due to overheating. Such a covering can be any material with a high thermal insulation value, such as, for example, glass, ceramic, or the like. For example, the magnets can be dipped in molten material, or a piece of such material can be glued or adhered to them. Such materials can include, for example, silicone, micro-porous silica, ceramics, or a glass ceramic, such as, for example, Macor™, provided by Corning Incorporated. Such covering can be provided so as to not substantially affect the magnetic field felt by the pan or pan handle, as the case may be, but so as to thermally insulate the magnets from overheating. [0060] Additionally, it is noted, exemplary cookware stands can be made so that the magnets that hold the cookware in place, but do not bear the load of supporting their weight. This is the case in the exemplary embodiments shown in FIGS. 1-2 and 10 and 13 - 14 , for example. To further facilitate this feature, in exemplary embodiments of the present invention bottom or vertical surfaces of exemplary cookware stands, can, for example, be keyed to interlock with pans, either a surface of a pan, or a pan handle, where the interlocking mechanism holds the weight of the cookware as opposed to the magnets. Such an interlocking mechanism can be, for example, a small protrusion at the bottom or side surface of a pan and a corresponding female hole on the side or bottom of a holder, or a protrusion or hole on a pan handle and a corresponding hole or protrusion, respectively on a vertical surface of a cookware stand. [0061] In exemplary embodiments of the present invention, the magnets provided in a storage device (e.g., to hold pans or join modular units) can be at least one of neodymium magnets, rare earth magnets, ceramic magnets, samarium cobalt magnets and AlNiCo magnets. The magnets can be embedded in a surface, as described above, or, for example, in alternate exemplary embodiments, can be long enough to extend through the length of an entire structural element of an exemplary cookware stand, and thus, for example, provide magnetic capability to both sides of a structural member, if desired. Alternatively, two magnets can be utilized on each side without the need for a single elongated magnetic material. [0062] In certain embodiments, the cookware stands may be manufactured by first creating a thermoplastic outer shell by injection molding or heat extrusion. A skilled artisan would recognize the injection molding techniques required to form a hollowed article, such as those, e.g., described in U.S. Pat. No. 5,098,637, or the heat extrusion techniques, such as those described in U.S. Pat. No. 6,368,547, the contents of which are hereby incorporated by reference. [0063] The cavity of the hollowed stand may then be filled with a resin or epoxy, preferably a resin or epoxy that is malleable at room temperature, thus no heated process is required for the internal cavity. [0064] In certain embodiments, when the thermoplastic mold is formed and filled with the resin or epoxy, minimal or no seams are present in the cookware stand. [0065] In certain embodiments, an internal liner may be inserted between the inner surface of the outer shell and the inner core of the cookware stand. In such embodiments, the internal liner is inserted into the hollow cavity prior to filling the cavity with the resin or epoxy. The internal liner is useful when the materials used to fabricate the outer shell are not compatible with the resin/epoxy used to fill the inner cavity. [0066] In certain embodiments, the material used for the outer shell of the cookware stand is a thermoplastic resin suitable for injection molding, such as, e.g., polycarbonate homopolymers, copolycarbonates, acrylonitrile-butadiene-styrene resins (ABS), styrene/acrylonitrile (SAN), polyamides, thermoplastic polyurethane, polymethylmethacrylate (PMMA Acrylics), thermoplastic urethane (TPU), Thermoplastic Elastomer (TPE), polyvinyl fluoride (PVF), poly vinylidine fluoride (PVDF), blends of polycarbonate, resins thereof, or combinations or mixtures thereof. [0067] In certain embodiments, the material used for the inner cavity is any type of resin which can be used at room temperature, e.g., acrylic or epoxy resin or any combination or mixture thereof. The acrylic resin can be, e.g., polymethyl acrylate or polymethyl methacrylate. The epoxy resin can be, e.g., either glycidyl epoxy (e.g., glycidyl-ether, glycidyl-ester and glycidyl-amine) or non-glycidyl epoxy resins (e.g., aliphatic or cycloaliphatic epoxy resins). [0068] In preferred embodiments of the present invention, the materials used will result in a clear or substantially clear cookware stand. However, in other embodiments, the materials can result in an opaque or even colored article if an opaque or colored cookware stand is desired. To achieve an opaque or colored cookware stand, the resin may contain a dye or suitable pigment to render to desired color or level of opacity. [0069] In certain embodiments, the outer shell can be treated with an ultraviolet light resistant additive to prevent discoloration (e.g., yellowing). The additive can be provided as a topcoat or incorporated into the mold material. Typical additives include benzophenones and can be present in an amount, e.g., from about 0.01% to about 10% or about 0.05% to about 5% or about 1% to about 2%, based on weight. [0070] In certain embodiments the resin added to the cavity needs additional cooling, e.g., when the cavity is greater than about 3 inches squared. The additional cooling can be by subjecting the filled product to cool air (e.g., by refrigeration or by a cool airstream). In other embodiments, the additional cooling can be by an extended time at ambient temperatures. [0071] The above-presented description and figures are intended by way of example only and are not intended to limit the present invention in any way except as set forth in the following claims. It is particularly noted that persons skilled in the art can readily combine the various technical aspects of the various elements of the various exemplary embodiments that have been described above in numerous other ways, all of which are considered to be within the scope of the invention.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a downrigger weight arrestor for lifting weights and maintaining the weights in an elevated position. 2. Description of Prior Art Downriggers are used for deep water fishing. Downriggers are usually attached securely on a side of a boat. Downriggers have a reel to which a length of cable is wrapped around, and a rod extending outwardly over the water. A pulley is positioned at the outer end of the rod. The cable is trained around the pulley and is weighted downward to where a weight is attached to the cable. The reel may be unwound to let the weight on the cable descend to desired depths in the water. A fishing line is removably attached to the weight so the fish hook can accompany the weight and descend to certain depths to where certain fish are most likely to be caught. A problem is encountered in downriggers with the ease to which the operator may grasp or secure the weight in a fixed position. The cable, when wound in, will have the weight dangling from its end. The weight when dangling on a downrigger attached to a moving boat is a safety hazard in that it is capable of swinging and hitting somebody plus capable of damaging the boat and downrigger. The downrigger rod is substantially longer than the human arm so it is not feasible for the operator to reach over and grab the weight plus the fact that the operator must reach over the side of the boat to grasp the cable or weight presents a danger which should be avoided. Various means have been devised to elevate the weight, draw it within reach of the operator, and to secure it in a relatively fixed position. To circumvent this problem of the dangling weight, downriggers have been manufactured with pivotal bases wherein the downrigger may be pivoted so the downrigger arm has its end within reach of the operator. The operator then manually grabs the weight or the downrigger cable and brings in the weight. Another apparatus heretofore employed has been a hook attached to an elongated shaft wherein the operator may reach overboard, hook and draw in the cable and manually grab and secure the weight. Another apparatus employed to lift the weight is a pull ring placed around the cable. Attached to the pull ring is a cord connected at its other end to the boat or downrigger. In the midsection of the cord a handle is attached. An operator may reach over and grab the handle and pull it upwards. Then, the handle may be hooked onto a stationary hook to maintain the weight in a secured elevated position. SUMMARY OF THE INVENTION The invention is a weight arrestor for a downrigger in which the weight arrestor has a means to guide a downrigger cable up and toward the operator. The guide means, when engaged with the cable, arcs a portion of the cable into smooth, curved configuration. A flexible arc producing means is attached to the guide means and flexes under stress from the cable for producing an arc in the cable of radius significantly larger than the diameter of the cable. Preferably, the weight arrestor has an elongated flexible tubular element in which the downrigger cable is positioned therethrough. The tubular element slides along the downrigger cable. When under stress from the cable, the tubular element will radially flex and the cable will be gently curved through the curved tubular element. The tubular element is adjustably coupled to a fastener which is mounted on the downrigger or boat. Preferably, the tubular element is coupled to the fastener by a cord. In a specific embodiment, the fastener adjustably fixes the cord running therethrough. Preferably, the tubular element is an elongated coiled spring. Around the exterior midsection of the spring there is a metal band having a side tab extending outwardly. The side tab has an aperture therethrough. The cord is operably attached to the side tab through the aperture. The cord runs through the fastener which is mounted on the downrigger and boat at a convenient position for the operator. The fastener has a lock position and a release position. Preferably the means automatically move the fastener to the lock position. In a specific embodiment, the fastener has two arms pivotally connected to each other. One arm has a channel facing the other arm. The channel is of sufficient size to have the cord lie therein. The other arm has a pressure tab at one end which engages the cord in a fixed position. Pivoting of the second arm lifts the pressure tab and disengages it from the cord allowing the cord to run freely within the channel. At the other end of the second arm, a hook is pivotally attached. The hook is pivotally mounted onto the downrigger. Preferably, the arm with the channel has a channel section curved away from the second arm at the end opposite the end which is adjacent the pressure tab of the second arm. The cord within the curved channel subtends a substantial angle when the fastener is in a lock position. Force is exerted on the cord by the weighted cable pulling on the flexible spring tube which is connected to the cord. This force causes the curved portion to pivot away from the second arm. This results in the pressure tab pivoting toward the channeled arm and engaging the cord and fixing it thereto. The fastener easily disengages from the cord by pressure exerted on the curved portion of the first arm toward the second arm. The cord is of sufficient length to always lie within the fastener channel whether the weight is within the water or out of the water. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view of a weight arrestor according to the invention in the arrested position. FIG. 2 is a side elevational view of the weight arrestor shown in FIG. 1 in the non-arrested position. FIG. 3 is a enlarged view of the element engaging the downrigger cable as viewed in FIG. 2. FIG. 4 is a enlarged view of the element engaging the downrigger cable as viewed in FIG. 1. FIG. 5 is a partial enlarged view of the cord as viewed in FIG. 4. FIG. 6 is an enlarged view of the fastening mechanism in the locked position as viewed in FIG. 1. FIG. 7 is a partially broken and enlarged view of the fastening mechanism when in the released position as viewed in FIG. 2. FIG. 8 is a cross-sectional view of the fastening mechanism shown in FIG. 6. FIG. 9 is a cross-sectional view of the invention engaging the cable shown in FIG. 4. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIGS. 1 and 2, the weight arrestor 10 is operably connected to a downrigger 13. The downrigger is fixedly secured to a side rail of a boat (not shown). The downrigger 13 has a cable 16 trained around a pulley 15 which is positioned at the outer end of outwardly extended rod 18 which extends over the water (not shown). The cable 16 is wound around reel 17. Reel 17 may be rotated to wind or unwind cable 16. A weight 20 is attached to cable 16 at the free end of cable 16. The weight arrestor 10 has an elongated coil spring 12 at one end and a fastener 38 at another end coupled together by a cord 28. The elongated spring 12 has an aperture 14 therethrough. A cable 16 from a downrigger 18 is positioned through the aperture 14 with a weight 20 attached to the end of the cable 16 and below the spring 12. The fastener 38 is pivotally mounted onto stem 19 of the downrigger 18. Referring to FIGS. 3 and 4, the coil spring 12 has its coils 29 contiguous to each adjacent coil. The spring 12 has 20 coils per inch of spring. Each coil has a 1/4 inch diameter. The spring is 1μ inches long. The multitude of coils in the spring 12 allows it to flex radially when under stress. As shown in FIG. 9, side 58 radially flexes and the cable 16 conform into a curvilinear configuration 21 having a relatively large radius compared to the diameter of the cable. The straight sections 23 of cable 16 connect to the curved section 21 of cable 16 at the ends of spring 12. The axis of straight sections 21 are tangential to the curve which the axis of curved section 21 defines. The spring is made from stainless steel so as to retard rust and maintain the flexibility of the spring for a long interval of time. The spring has attached to it at its exterior midsection a metal band 22 which is tightly clamped around the spring 12. A side tab 24 extends outwardly from the metal band 22. The side tab 24 has an aperture 26 therethrough. A nylon cord 28 has a looped end 30 which passes through aperture 26. Referring to FIG. 5, the looped end 30 has a metal reinforcement 32 crimped around the inside perimeter of the looped end 30. The reinforcement 32 has slotted ends 34 through which the nylon cord 28 is crimped, thus maintaining the metal reinforcement 32 securely onto the looped end 30. Clamps 36 securely bind the nylon cord 28 onto itself to form the looped end 30. The cord runs to the fastener 38, as shown in FIGS. 6 and 7. The fastener 38 has two arms 40 and 42 pivotally connected to each other by a pin 44. An aperture 46 passes through the upper end of arm 40. A hook 48 passes through aperture 46. The hook has a head 50 which prevents the hook from passing completely through aperture 46. The hook is pivotally mounted on downrigger 18. As shown in FIG. 8, arm 42 has a channel 52 in which cord 28 may be positioned. Channel 52 has a portion 53 substantially curved away from arm 40. Arm 40 has a tab 54 at an end opposite aperture 46. Tab 54 engages nylon cord 28 and secures it against a straight part 56 of channel 52. As shown in FIG. 7, tab 54 disengages cord 28 when arms 40 and 42 pivoted so that the aperture end of arm 40 is near arm 42. A knot 60 is placed at the loose end of cord 28. The knot 60 is larger than channel 52 which prevents the cord 28 from becoming disengaged with fastener 38. Referring to FIG. 2, the downrigger 13 has its cable 16 trained around pulley 15 and extending vertically downward to where weight 20 is attached. Reel 17 is unwound to allow weight 20 to descend a desired depth in the water. A fish line may be attached to the weight before decent of the weight and the operator may deep-water fish or go trolling in the boat. Fastener 38 is in a released position and spring 12 is straight and free to slide along cable 16. Knot 60 prevents the cord 28 from disengaging from fastener 38 and keeps the cord 28 within easy reach for the operator. When fishing is no longer desired, the reel 17 is wound and cable 16 is wound up and lifts weight 20 out of the water. The weight is now in a dangling position. To bring in and secure weight 20, cord 28 is pulled and the pulling on the cord 28 draws in spring 12 and consequently cable 16. As cable 16 is pulled away from its vertical position it will be under tension to return to it. The stress is exerted on spring 12 which flexes. The flexing forces the cable 16 to be shaped in a curvilinear configuration having a large radius instead of a natural tight curve which can distort or permanently bend cable 16. Referring to FIG. 9, the cable 16 is in contact with the inner radially curved side 58 of spring 12. As shown in FIG. 1, after the cord 28 is pulled, the weight is in a secure and close position to the operator. Fastener 38 will automatically lock when cord 28 is released. The cord which is under tension from the spring 12 and curved cable and will be pulled away from fastener 38. The cord pulls curved channel section 53 of arm 42 away from the aperture end of arm 40. The movement of these ends of arms 40 and 42 causes tab 54 to engage cord 28 at the straight channel section 56 from 42. The weight 20 can be secured in the arrested position for an indefinite amount of time. When the weight is desired to be released, the operator presses aperture of arm 40 and the curved channel section of arm 42 toward each other. The inward motion will disengage tab 54 from cord 28. The weight 20 is free to swing away from downrigger 13 and obtain a position as disclosed in FIG. 2. The weight 20 can be lowered into the water by unwinding of cable 16 from reel 17. The invention provides an efficient and economical way to elevate the weight of a downrigger and to minimize any harmful stresses encountered by the cable in the elevation of the weight. A simple pull on cord 28 will elevate weight 20 and bring it toward the downrigger 18 in a elevated position. A simple squeeze or fastener 38 will release the weight from the elevated position. The spring 12, as it slides along weighted cable 16, radially flexes under any stress exerted by the weighted cable 16. The radial flexing of the spring 12 minimizes the harmful stress placed upon a single point on the cable. As a result the cable does not become distorted, curled or frayed upon the multitude of times the spring 12 will slide along cable 16 during the operation of the invention. It should be understood that the foregoing embodiment of the invention is merely illustrative of the preferred practice of the invention and various changes and modifications may be made in the arrangements and details of construction of the embodiment described without departing from the spirit and scope of the invention.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to pre-sweetened sugar-coated breakfast cereals and, more particularly, to the recovery of sugar from broken pieces of sugar-coated cereal that have fallen off or broken off the cereal product during production. 2. Description of Prior Art Cereal pieces are typically prepared by cooking a cereal dough, shaping the dough into pellets or flakes and puffing or toasting the shaped dough. Pre-sweetened breakfast cereals have been regularly available to the consumer for several years. Such cereals have been prepared by first producing unsweetened cereal pieces, coating the cereal pieces with a sucrose slurry and drying the coated pieces in a dryer. One approach for preparing breakfast cereal flakes is disclosed in U.S. Pat. No. 1,161,323. A grain such as corn grits is combined with salt, cane sugar and water. The combination is heated in a steam-tight cooker thereby cooking the grain material. The cooked grains are partially dried and then passed between spaced smooth-surfaced flaking rolls. The resulting flakes are puffed by baking or roasting. In other instances whole kernels of grain have been puffed to provide a breakfast cereal. U.S. Pat. No. 1,266,448 shows such a process in which rice kernels are soaked in water for 36 hours. The kernels are then subjected to heat until the kernel surface is dried. The dried kernels are popped in a popper much like popcorn. A further process for preparing ready-to-eat breakfast cereals is described in U.S. Pat. No. 3,453,115. Cereal dough is prepared from any of various cereals such as corn, wheat, barley and oats. The dough is pressure cooked and pelletized. The pellets are partially dried to provide case hardening and then flaked between rolls. The various ready-to-eat breakfast cereals have been sweetened by coating the finished cereal pieces with sugar. The previous unsweetened cereals have the disadvantage that table sugar, which is added to the cereal and milk mixture at the time of eating, is added in excess and remains in the bottom of the cereal bowl after the cereal has been consumed. The pre-sweetened cereals overcome such disadvantage and provide an appropriate amount of sugar which is not wasted. U.S. Pat. No. 2,196,395 describes a process for candy-coating cereal in which the cereal is mixed with a hot sugar solution containing a fat or oil. The sugar solution can be in the form of molasses, glucose or cane sugar. The process is designed to permit the sugar-coating of relatively fragile cereal products, such as flakes, which may be damaged by other coating techniques, and is also stated to give the product good storage stability. U.S. Pat. No. 2,333,442 describes the coating of a puffed cereal product with a honey-flavored candy coating. The coating is produced by contacting the cereal product with a hot solution containing sugar, honey flavoring and hardening agents. Following coating, the coated cereal is cooled to produce separation of the individual grains of sugar. It is stated that the process produces a hard coating which maintains its integrity and texture for long periods of time. U.S. Pat. No. 4,211,800 d1scloses a flaked cereal product coated with sugar and oil to enhance both sweetness and storage stability. This process discloses a cereal flake in which the grain is either corn, wheat, or oats. The grain is first cooked and then dried to below 20% moisture. After tempering, the grains are heated to a temperature between 140° F. and 200° F. in order to produce a ppliable particle, The grains are then flaked, toasted, oil coated, and then sugar coated. U.S. Pat. No. 3,615,676 discloses a sugar-coated ready-to-eat cereal. Sugar is applied to the surface of cereal pieces and caused to adhere thereto by moistening the cereal pieces with water and a binding agent. U.S. Pat. No. 3,976,793 also shows sugar-coated ready-to-eat cereal flake. In this process, oat, soy & wheat flour are made into a dough. The dough is cooked, formed into pellets and then dried to a moisture content below 21%. The pellets are then flaked, toasted and sugar-coated. All of the above sugar-coating processes have the disadvantage that a significant amount of sugar is lost due to breakage of the cereal. This breakage occurs whether the cereal is in the form of flakes, shreds, puffs or an extruded product. This breakage results in a high concentration of "dust" or "fines" which increases the cost of the final product. This is particularly true where the fines contain a high amount of sugar, say 65-90% sugar vs 10-35% cereal solids. Efforts to recycle the sugar-cereal fines into the pure sugar syrup which is used for coating the cereal have been limited since only small amounts (less than 6%) have been able to be added without deleteriously effecting the quality of the sugar coating. This is due to the presence of starch (from the cereal) in the recycled sugar. Attempts to dissolve the sugar-cereal fines in water, and then separate the liquid sugar from the insoluble cereal (starch) particles by the use of filtration techniques has not worked due to plugging of the filters by the starches in the cereal and also by the mineral nutrients (zinc & iron) added to the cereal during production. It would be very advantageous if the sugar fines could be dissolved, separated & purified to a point where more than 6% and as high as 20-30% of the reclaimed sugar could be recycled or added back to the original sugar syrup used for coating the cereal products. SUMMARY OF THE INVENTION The present invention relates to an improvement in the process for applying a sugar solution to the surface of a cereal product, drying the sugar-coated cereal, collecting the fines of sugar and cereal produced therefrom, and recycling said collected fines back into the original sugar solution. It has now been found that the sugar-cereal fines can be contacted with water to form a slurry of dissolved sugar and insoluble cereal particles, which then can be separated into a liquid sugar fraction and an insoluble cereal fraction by centrifugation in a solid bowl centrifuge. This is accomplished by following these steps: collecting fines having (by weight) a sugar content of 65-90% sugar and a cereal content of 10-35%; forming a slurry of the sugar-cereal fines with water at a temperature of 130° to 175° F. and a water: fines ratio (by weight) of between 0.7:1.0 and 1.5:1.0; mixing the slurry vigorously for 2 to 30 minutes to dissolve all the sugar fines and wet all the cereal fines; adjusting the water content of the slurry to achieve a specific gravity of between 1.18 to 1.40; separating the dissolved sugar from the wet cereal fines by the use of centrifugation in a solid bowl centrifuge; recycling the dissolved sugar into the pure sugar solution. In the case where the collected fines have a sugar content of 80-90% and a cereal content of 10-20%, a preferred ratio of water:fines in the slurry is about 0.9:1.0, a preferred mixing time is 5 minutes, and a preferred specific gravity prior to centrifugation to separate the sludge from the sugar solution is a specific gravity of 1.28. In the case where the collected fines have a sugar content of 65-70% and a cereal content of 30-35%, the preferred water:fines ratio in the slurry is 1.3:1, the slurry is mixed for 20 minutes, and the final specific gravity prior to centrifugation should be 1.20. BRIEF DESCRIPTION OF THE DRAWING The accompanying drawing is a diagrammatic flow sheet illustrative of one embodiment of a sugar recovery process in accordance with the present invention. While the process is described in connection with the recovery of sugar from broken pieces of a dried, sugar-coated puffed cereal, it is to be understood that recovery of sugar from other sugar-coated cereal products such as flaked, shredded, extruded or ground cereal can be effected in essentially the same manner. The sugar in the examples is sucrose, but fructose, glucose, dextrose or any other sugar suitable for coating cereals can be employed. The process contemplates the use of known and conventional equipment which is readily available from several suppliers. DETAILED DESCRIPTION OF THE INVENTION Prior to forming the aqueous slurry of fines, it is preferred to sift the fines in a sifter to increase the density of the cereal particles present in the sugar fines. These sifted fines have a mesh size of between 20 and 60 mesh (U.S. Standard Sieve), preferably 30 to 50 mesh. This enables the cereal particles to be wet or suspended within the slurry as distinguished from floating on the surface of the slurry. Any floaters can be skimmed off the surface of the slurry. In forming the slurry it is only necessary to use sufficient water to completely dissolve the sugar in the fines while wetting the cereal particles which will remain insoluble. The ratio of water added on a weight basis is about 1:1 but may vary between 0.7:1.0 and 1.5:1.0. Preferably, the ratio of water:fines is between 0.9:1.0 and 1.3:1.0. In the case where the cereal levels in the fines approaches 35%, the ratio of water:fines may approach 1.4:1.0 to achieve proper wetting of the cereal fines. The temperature of the water in contact with the fines is preferably 170° F. but can range from 130° to 175° F. The temperature of the water should be sufficient to dissolve all the sugar present in the fines but sufficiently below the temperature where the water could vaporize or "boil." After the slurry is formed, it is necessary to vigorously mix or agitate the slurry to achieve maximum contact of the water with the surface of the fines. This will dissolve the sugar while effectively wetting the insoluble cereal particles. Where the fines have a cereal content of 10-20% about 5 minutes of mixing is needed to achieve the wetting action necessary to dissolve all the sugar in the fines while at the same time wetting the insoluble cereal particles. Where the sugar content approaches 65% and the cereal content approaches 35%, it may be necessary to agitate or mix the slurry vigorously for about 20 minutes to achieve the necessary wetting action of the cereal particles. Once all the sugar is dissolved and the cereal particles are sufficiently wet, the slurry water content is adjusted to achieve a specific gravity of between 1.18 and 1.40. In the case of a puffed cereal product having fines with a sugar content of 80-90% and a cereal content of 10-20%, the preferred specific gravity is 1.28. In the case of puffed cereal fines containing up to 65% sugar and up to 35% cereal, the preferred specific gravity is 1.20. At the above specific gravitities, the slurry is easily separated by the centrifugal action of a solid bowl centrifuge into an insoluble sludge (cereal particles) and a relatively pure liquid sugar solution. The use of perforated bowl centrifuges does not work due to plugging of the holes in the centrifuge by the starches, zinc & iron present in the cereal product. The reclaimed sugar solution can be blended back or recycled to the original sugar syrup used for coating the cereal at a level of 10 to 20%, and as high as 30% without effecting the quality of the sugar coating on the cereal. Cereal products suitable for sugar-coating by the process of the invention are well known to those skilled in the art and hence it is unnecessary to describe in detail the production of such cereal products. The choice of an appropriate flour and other components of the dough used to form the cereal products is of course governed largely by the taste and texture desired in the final coated cereal product. It has been found that doughs based on corn flour, oat flour, rice flour and wheat flour give good results in the process of the invention. The exact geometric form of the cereal product subjected to the process of the invention is not critical and any of the forms of cereal product which will be familiar to those skilled in the art may be used. For example, the cereal product may be in flake form, shredded form, gun-puffed form or extruded form. When an extruded form is used, the extruded cereal product may be in the form of spherical pieces, such as those used in certain commercially-available breakfast cereals. In general, it is desirable that the moisture content of the cereal product, prior to contact with the sugar solution, be in the range of 1 to 10% by weight. The sugar solution may employ any sugar, such as sucrose, fructose, glucose, or other known sugars familiar to the art. In order to ensure a uniform coating of the cereal product with the sugar solution, it is preferred that the sugar solution be applied to the cereal product by spraying. Most uniform application of the sugar solution is promoted by agitating a mass of particles of cereal product while spraying sugar solution onto the mass from above. Those skilled in the art of food technology will be familiar with rotatable drums provided with internal baffles which can be used to tumble or agitate and transfer a mass of particles of cereal product in a way that allows a coating to be very uniformly applied, and such drums are suitable for use in the application of the sugar solution in the process of the instant process. Normally, it will be most convenient to coat the whole surface of the particles of cereal with the sugar solution. However, we do not exclude the possibility that the sugar solution might be applied only to part of the surface of the cereal particles, for example by dipping large particles into a shallow bath of the sugar solution. The preferred concentration of sugar solution for use in the process of the invention is from 60 to 85% by weight. If the sugar solution is too dilute, it may be insufficiently sticky to promote adhesion of the flavoring composition to the cereal product and renders the drying of the product difficult and inefficient because of the large quantity of water which must be removed to deposit a given quantity of sugar. On the other hand, while if the sugar solution is too concentrated, it may become viscous, difficult to spray and difficult to apply uniformly in a thin layer to the cereal product. It is desirable to incorporate an emulsified oil into the sugar solution. The presence of such oil produces better flow of the solution through any nozzle or spray heads used to spray the solution onto the cereal product. In addition, the presence of the emulsified oil promotes foaming of the sugar solution in contact with the cereal product. A foamy layer of sugar solution is desirable in order to give a frosted appearance to the product. We have found that best results are obtained by incorporating from about 0.5 to about 5% by wt. of oil into the sugar solution. Obviously, the oil used must be edible and should also be relatively easy to emulsify in the sugar solution. Preferably, the weight of sugar solution applied to the cereal product is from about 15 to 65% by wt. of the cereal product. DESCRIPTION OF THE PREFERRED EMBODIMENT EXAMPLE 1 Referring to the drawing, fines (broken pieces of dried sugar-coated puffed oat cereal) from the production of "Alpha-Bits" are introduced through line 10 into sifter 12 which sifts out the larger sized pieces to give a mesh size of 30-50 mesh (US Standard Sieve). The fines (80-90% sugar and 10-20% cereal on a dry weight basis) drop through line 14 onto auger 16 which feeds the fines through line 17 into loading bin 18. When the bin 18 reaches 900 lbs of fines, 850 lbs of water at 170° F. enters the mix tank 25 through line 24. As soon as the water shuts off, the mix tank agitator 28 starts running at 1,450 r.p.m. When the loading bin 18 reaches 1,000 lbs of sugar fines and the mix tank 25 is less than 65% full, the augur 20 & slidegate (not shown) below the bin 18 turn on & open respectively. Also, at this point, a diverter (not shown) which empties the fines into bin 18 through line 17 diverts the fines into another holding bin (not shown). When the loading bin 18 drops below 900 lbs while emptying, the diverter then diverts the fines back into the loading bin 18. The slidegate and augur 20 below the bin 18 remain open for 211/2 minutes and 22 minutes respectively. After augur 20 shuts off, the mix tank agitator 28 runs for 5 minutes, then shuts off. Pump 31, viscosity meter 41, and centrifuge 51 are then turned on. The sugar slurry in mix tank 25 is pumped through line 30 into the viscosity meter 41 and recirculated back into the mix tank 25. The viscosity meter 41 is a Flow Meter (Model #DL1005202) manufactured by Micro Inc., 2505 S. Finley Road, Lombard, Ill. 60148. This meter is capable of detecting the permissible slurry temperature (130° to 175° F.), the permissible brix level (45 to 60), and the permissible specific gravity (1.18 to 1.40). In this example, the meter will read a slurry temperature of 155° F., a brix level of 57 and a specific gravity of 1.3. Since a specific gravity of 1.28 is preferred for the sugar: cereal ratio of this example, a 3-way control value opens and allows 80 lbs of additional water to enter the mix tank 25. The specific gravity will now read 1.28 and the 3-way value which recirculates back to the mix tank 25, switches and allows liquid slurry to go into a solid bowl centrifuge 51. This centrifuge is manufactured by AML Industries, 3500 Davisville Road, Hatboro, Pa. 19040. The centrifuge has a Model #B50 and Serial #5112, Speed Setting of 1,750 r.p.m., and a Stop Time Setting of 3 minutes. (The speed is reduced to 1,450 r.p.m. with an Allen Bradley Model #1336 frequency controller while the stop time is reduced to 2-30 seconds with an Allen Bradley dynamic brake used in conjunction with the 1336 frequency controller). As the dissolved sugar liquid passes through the solid bowl centrifuge 51, the cereal solids are separated from the liquid sugar by the centrifugal action of the bowl and deposited on the inside of the bowl. After 4 minutes a discharge tube turns on for 20 seconds and uses centripetal force to clean out the bowl. The cereal solids are discharged through line 53 and used for animal feed. The liquid sugar is gravity fed into a small holding tank 60. After the tank 60 reaches about 35% full, a level indicator turns on a pump and pumps the liquid sugar into the reclaimed sugar syrup tank 70 until the small holding tank 60 reaches 5% full. The reclaimed syrup from tank 70 is blended with the pure liquid sugar used for sugar-coating the puffed cereals at a blend ratio of 7 to 20%. EXAMPLE 2 The procedure of Example 1 is repeated for "Honey Comb" (a sugar-coated puffed cereal of wheat and corn). This cereal has a sugar level of 65-70% and a cereal level of 30-35% in the collected fines. When the bin 18 reaches 900 lbs of fines, 1,200 lbs of water (instead of 850 lbs of water enteres the mix tank 25 through line 24. After auger 20 shuts off, the mix tank agitator 28 runs for about 20 minutes (instead of 5 minutes) and then shuts off. Since a specific gravity of 1.20 has been found to give the best separation results for the fines of this example, the water:fines mixture is adjusted to achieve a specific gravity of 1.20. The slurry is then passed through the solid bowl centrifuge 51 to separate the cereal sludge from the liquid sugar. After 31/2 minutes (instead of 4 minutes) the discharge tube turns on for 30 seconds (instead of 20 seconds) and uses centripetal force to clean out the bowl. It will be apparent to those skilled in the art that various changes can be made in the preferred embodiments without departing from the scope of the invention. Accordingly, the foregoing discription should be construed as illustrative and not limiting, the scope of the invention being defined solely by the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Not Applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable. FIELD OF THE INVENTION [0003] The present invention relates generally to a device that can be used to provide biosensory feedback that would not otherwise be available to an individual, so that the individual can gain increased ability to move his or her natural and/or prosthetic limbs. More particularly, the present invention provides a means for providing feedback that can allow an individual to better recognize and distinguish between perception of various body movements or positions. BACKGROUND OF THE INVENTION [0004] Proprioception involves neuromuscular receptors in the skeletal muscles and on the surface of the tendons. These receptors provide constant feedback to the brain regarding movement, posture, changes in equilibrium, knowledge of position, weight, and resistance against its body parts. Using this feedback, the brain is typically able to correct or adapt to changes in these parameters. Amputees, and particularly amputees who have been fitted with prostheses, must learn to move their natural and prosthetic limbs without the benefit of proprioceptive feedback from the limb that is no longer present. [0005] In cases of limb amputation, it is typically necessary for the amputee to undergo rehabilitation in order to regain functionality that is as close to normal as possible. In particular, if the amputated limb is replaced with a prosthesis, it is necessary for the amputee to learn to use the prosthesis in a way that will maximize restored functionality. The rehabilitation prescribed in such cases is designed to modify the amputee's proprioception such that he or she learns to use the prosthesis in a manner that approximates that of the lost limb. [0006] At the same time, amputees often sense that the amputated limb is still present. This is known as Phantom Limb Syndrome. Phantom sensations can occur as passive proprioceptive sensations of the limb's presence, or more active sensations such as perceived movement, pressure, pain, itching, or temperature. The etiology of the phantom limb phenomenon is not well understood; both neurological and psychological explanations have been postulated. The sensations can be distressing, and patients are often counseled to ignore or suppress them. [0007] Still further, after many types of major surgery, including amputation, moderate forms of exercise are prescribed as beneficial to the healing process. Exercise that directly affects the wounded area, e.g. amputation cite, while particularly helpful for increasing blood flow and reducing atrophy and stiffening, also brings associated risks of increasing damage to the wounded tissue, such as through trauma or excessive stress. [0008] It would be advantageous to provide a device that allows an amputee to re-direct and use the sensory perceptions associated with a phantom limb in re-establishing proprioception with respect to his or her prosthesis. It would also be desirable to provide a system that allows an amputee to obtain the benefits of exercise and a desired level of vaso-stimulation without risking tissue damage. SUMMARY OF THE INVENTION [0009] The present invention includes a device and system that allow an amputee to re-direct and use sensory perceptions, including those associated with a phantom limb, in re-establishing proprioception with respect to his or her prosthesis. In certain embodiments, the present invention features a device adapted to engage a prosthesis and to provide sensory feedback when certain events or physical standards are met. [0010] The present invention comprises a combination of features and advantages which enable it to overcome various problems of prior devices. The various characteristics described herein, as well as other features, will be readily apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments of the invention, and by referring to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0011] For a more detailed description of the preferred embodiment of the present invention, reference will now be made to the accompanying drawing, which is an illustration of a system constructed in accordance with a first embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0012] Referring initially to FIG. 1 , an exemplary system in accordance with the present invention, includes a prosthetic foot 10 , a microprocessor 50 , a signaler 60 , and an output device 70 . Prosthetic foot 10 typically will include a heel 12 , a toe 14 , and an attachment member 16 . Prosthetic foot 10 can be any type of prosthetic foot, such as are generally known in the art Likewise, attachment member 16 may comprise a standard “Otto Bock”-type connector, such as are commercially available, or may comprise any other attachment means that can serve to attach the foot to the amputee. [0013] According to certain embodiments, foot 10 includes at least one, and preferably two or more sensors 20 , 22 . Sensors 20 , 22 are preferably low-profile, highly-accurate pressure sensors, such as are readily commercially available. Both sensors are positioned on the bottom of the prosthesis, so that they contact the ground when the wearer puts pressure on (stands on), the prosthetic foot. One sensor, forward sensor 20 , may be positioned tinder the forward portion of the foot, while the other sensor, rear sensor 22 , may be positioned under the heel of the foot. Sensors 20 , 22 are preferably coupled to a microprocessor 50 so that sensor signals 24 representative of pressure sensed by each sensor can be received and processed by microprocessor 50 . For example, sensors 20 , 22 may be wired to microprocessor 50 or may be connected to a wireless transmitter (not shown), such as an infra-red transmitter, which transmits the signal to a corresponding receiver, which receives the signal and sends it to the microprocessor. Means for transmitting signals are known. [0014] When foot 10 including sensors 20 and 22 is worn and used, sensors 20 , 22 will sense pressure loads that correspond to the gait of the wearer. According to embodiments of the invention, information relating to these loads can be processed and sent to the wearer in a manner that enables the wearer to increase his rate of healing. Specifically, it is envisioned that the system will be programmed to give the wearer feedback relating to the magnitude, positioning and timing of the loads on the foot. [0015] In order to give the wearer information about the magnitude various techniques may be used. In each case, the signal from at least one of the sensors is converted by microprocessor 50 into an output that represents the amount of pressure (weight) that is applied to the foot. If two or more sensors are used, it is preferred to obtain the magnitude of the total pressure by summing the signals from all of the sensors. [0016] In certain embodiments, microprocessor 50 may be programmed to compare the magnitude of the pressure applied to the prosthesis to a predetermined target value. In these embodiments, the microprocessor output may include triggering an audible or visible indicator when the target value is reached. In other embodiments, the microprocessor output may include an audible or visible signal corresponding to the measured value. For example, the microprocessor may be connected to a digital or analog output device 70 that indicates numerically or graphically the magnitude of the pressure being applied to the foot. Alternatively, the output may comprise an audible signal that indicates through pitch or volume the magnitude of the applied pressure. [0017] In other embodiments, the wearer may be further equipped with a signaler 60 , which may include means for manually sending a signal to the microprocessor. Signaler 60 may include a belt-pack and finger switch, or the like, such as are readily commercially available. It will be understood that the terms “manual” and “finger” are not intended to limit the device; the system can include any device that can send signal in response to actuation by the patient. A signal 64 sent by signaler 60 in response to actuation by the patient will be referred to hereinafter as a “manual signal.” [0018] In these embodiments, microprocessor 50 may be programmed to monitor the magnitude of the pressure applied to the prosthesis. For example, microprocessor 50 may be programmed to provide an indication when the actual (detected) load is the same as, or within a predetermined range of, a target value. Alternatively, the microprocessor can provide to the wearer feedback that is indicative of the magnitude of the difference, if any, between the actual load and the target value. [0019] In some embodiments, an objective therapeutic goal would be for the wearer to achieve sufficient proprioception to be able to correctly sense target weight loads. In these cases, the wearer may be instructed to manually actuate signaler 60 when he or she believes that a predetermined target pressure is being applied. By comparing the measured or detected weight at the time that manual signal is given to the target weight, the system can provide feedback to the wearer, indicating the difference between the two. [0020] In some embodiments, the wearer is again outfitted with a signaler, but the microprocessor is programmed to calculate a projected time for reaching the target value. Using the projected time calculation and the existing time and magnitude, the microprocessor can output a signal that is indicative of the amount of time by which the wearer's manual signal is premature or late. For example, the system can be programmed to give a visual or audible signal such as “1 second early” or “½ second late.” Other means of indicating the relative timing of the manual signal and the target pressure may include timed tones, timed lights, digital readouts, and the like. The manual signal can be compared to either an extrapolation of the measured signal, which is particularly useful when the manual signal precedes the target pressure, or on a measurement of the actual pressure, which is more accurate. Measurement of the actual pressure can only be used if the target pressure is actually reached, either before or after the manual signal is given. If the feedback is based on an extrapolation of the measured signal, the microprocessor preferably uses the rate of increase in the load during the period that the load is increasing to determine when the target load would have been reached if loading had continued at that rate. Thus, in these embodiments, the system is programmed to calculate rate as well as magnitude and timing of load. [0021] In still other embodiments, the prosthesis may be adapted to provide the wearer with feedback relating to the position of the prosthesis relative to the wearer. In some embodiments, the position of the prosthesis is determined by comparing the relative magnitudes of the signals from the two sensors 20 , 22 , and using the ratio to determine position. For example, as the prosthesis is moved forward, away from the wearer, the load on the rear sensor 22 will increase relative to the load on the front sensor 20 . The ratio of the loads on sensors 20 , 22 can be compared to a look-up table or otherwise calibrated so as to provide information relating to the position of the prosthesis relative to the wearer. Front and rear sensors 20 , 22 can provide information about the positioning of the prosthesis in front of or behind the wearer; lateral positioning, i.e. to the left or right of the wearer, if desired, can be provided by providing at least one sensor that is shifted laterally with respect to a second sensor. By way of example, an optional third sensor (not shown) can be added beside or between sensors 20 , 22 , so long as it does not lie on a line between sensors 20 , 22 . In other embodiments, the prosthesis may include other types of sensors, such as position sensors, infra-red sensors, accelerometers, or inclinometers, that are adapted to provide the information that can be used in the enhancement of proprioception. [0022] As with the magnitude and timing feedbacks, position feedback can be given by various audible or visible means. In preferred embodiments, the wearer may manually signal when he or she believes that the prosthesis is in a predetermined target position and the system will indicate whether the manual signal is early or late and/or the degree to which the wearer is in error. [0023] The sensors described herein can be incorporated into or adhered onto a prosthetic foot, which may be a standard prosthetic foot or a prosthesis that is customized for a particular patient. Similarly, the sensors can be incorporated into a shoe, sock or slipper that can be applied to any prosthetic foot. As used herein, the term “shoe” encompasses all such terms and all other items that can be worn on a foot. It is envisioned that a shoe equipped with sensing and feedback mechanisms as described herein could also be used with a natural foot, if it were desired to provide such feedback to a non-amputee. Such might be the case, for instance, in cases of nerve damage that prevents the patient from sensing his own limb(s). It will thus be understood that the sensors of the present invention are not limited to use in the context of prosthetic feet or to use by amputees. Rather, they can be applied to any site where it is desired to provide proprioceptive feedback. In the case of an amputee, the feedback site will typically be the terminus of the remaining partial limb. Likewise, it will be understood that the sensors can be affixed to the feedback site indirectly, such as by means of a prosthesis or shoe, or directly, such as by direct adhesion. [0024] By providing quantitative feedback indicative of the accuracy of the patient's proprioception, the present system provides a mechanism for enhancing that proprioception. This is in contrast to many existing systems, which provide little or no feedback. In addition, the present system can be programmed to track the development of proprioceptive skills by a patient, so that the course of therapy can be monitored. In other embodiments, the quantitative feedback provided by the present system can be used to facilitate the selection of a prosthesis on the basis of the patient's proprioceptive response. [0025] Additional advantages of the present invention may include a reduction of perceived real pain, as a result of distraction, and authentication of phantom perception. [0026] While preferred embodiments of this invention have been shown and described, modifications thereof can be made by one skilled in the art without departing from the spirit or teachings of this invention. The embodiments described herein are exemplary only and are not limiting. Accordingly, the scope of protection is not limited to the embodiments described herein, but is only limited by the claims that follow, the scope of which shall include all equivalents of the subject matter of the claims.

1a

CROSS REFERENCE TO RELATED APPLICATION [0001] The present application claims priority from U.S. Provisional Patent Application No. 61/287,077, filed Dec. 16, 2009, the disclosure of which is incorporated by reference in its entirety herein. FIELD OF THE DISCLOSURE [0002] Exemplary embodiments of the present disclosure relate to arrangements and methods for effecting an endoluminal anatomical structure, and more particularly to arrangements and methods for treatment of gastrointestinal lesions that currently require open abdominal surgery. The exemplary embodiment of at least one of the arrangements can provide an endoluminal colon chamber and a variety of maneuverable operating tools inside that chamber. For example, the exemplary embodiment of such arrangement can function as a miniature operating room inside the colon. BACKGROUND INFORMATION [0003] Current endoscopic technologies may not facilitate treating colon perforations, large polyps and tumors, and a significant colon bleeding effectively and safely. A gastrointestinal bleeding is a common and potentially life-threatening medical condition, which can complicate any polypectomy (polyp removal), and excision of colonic tumors. A colon perforation can occur when excessive mechanical force or excessive energy is inadvertently applied to a colonic wall. A colon perforation is a life-threatening condition and currently requires major emergency surgery to close the colon perforation and preclude fecal contamination of an abdominal cavity and resulting sepsis. [0004] Consequently, many patients who develop large polyps, colon perforation, colon bleeding and other significant colon pathology currently have to undergo a major surgery and endure a significant operative trauma and, typically, painful and prolong recovery. Currently there are no effective and safe devices and methods for replacing major abdominal surgery in case of colon perforation or when large wide-based polyps need to be removed. [0005] Thus, there may be a need to address at least some of the deficiencies described herein above. [0006] U.S. Provisional Patent Application Ser. No. 61/247,605 filed on Oct. 1, 2009 and entitled “Detachable Balloon Catheter” describes exemplary embodiments of device and method for treatment of a gastrointestinal perforation and/or a gastrointestinal bleeding. The exemplary device can include a balloon catheter that can control bleeding by pressing on a bleeding area or/and prevents the gastrointestinal contents trespassing outside a gastrointestinal lumen into a body cavity by blocking an opening in the luminal wall or blocking the colon distal to the perforation. Such exemplary device can be inserted using an endoscope, and can allow a partial or complete withdrawal of an endoscope, while leaving the balloon at the target area. More specifically, the exemplary device and method can facilitate ceasing a colonic bleeding and blocking a colon perforation. [0007] The Minos Megachannel is a large bore flexible reinforced tube, which is designed to be inserted over the standard colonoscope. After the colonoscope is removed, the tube can be used as a passage for insertion of different instruments into the colon. [0008] Further, conventional endoscopes generally have one to two working channels, which likely do not have independent movements from the main body of the endoscope. As a result, when conventional flexible endoscopic instruments are inserted via such channels into the intestinal lumen, an operator can only manipulate these instruments axially (e.g., forward and backward movements), and possibly somewhat rotationally. In addition, since the conventional instruments can only be advanced from the tip of the endoscope towards the target lesion axially and in front of the endoscopic image, the conventional instruments have only limited functionality. [0009] Accordingly, there may be a need to address at least some of the deficiencies described herein above. SUMMARY OF EXEMPLARY EMBODIMENTS OF THE PRESENT DISCLOSURE [0010] Exemplary embodiments of the present disclosure can address most if not all of the above-described needs by providing device and method for a treatment of, e.g., a gastrointestinal perforation, bleeding, removal of large polyps, and/or other significant endoluminal pathology, for example, colonic pathology. [0011] According to one exemplary embodiment of the present disclosure, the device can function as a miniature operating room inside the lumen, for example, colon, and providing an operator with advanced endoluminal functionalities replicating capabilities of a surgical suite. The exemplary device of the present disclosure can provide such miniature endoluminal operating room, chamber or at least partial enclosure, and the ability to utilize a variety of articulating surgical instruments, which can operate within, at or around the chamber. [0012] According to one exemplary embodiment of the present disclosure, the exemplary arrangement/device can be introduced after a standard diagnostic colonoscopy is performed. An exemplary balloon guide catheter, as described in U.S. Provisional Patent Application Ser. No. 61/247,605, or a large endoluminal channel such as a Minos Megachannel manufactured by, e.g., Minos Inc., can be used to facilitate the insertion of the exemplary device according to the present disclosure. [0013] In another exemplary embodiment of the present disclosure, the arrangement/device can contain a plurality (e.g., three) primary sections, e.g., a handle, a multi-lumenal tube, and an expandable chamber. [0014] It is possible to utilize endoluminal channels and associated articulating endoluminal instruments with the exemplary embodiments of the arrangement/device. To that end, the exemplary arrangement/device can include a multi-lumen tube. The multi-lumen tube can include lumens for at least two special tools or tool-channels, or three or more special tools and/or tools-channels. In addition, the multi-lumen tube can include other channels, which can be used for, as an example, air, water, vacuum delivery, etc. The exemplary arrangement/device can also include channel for scope and illumination; and lumens for a chamber activation and lumen for a balloon guide catheter as indicated herein. [0015] According to still another exemplary embodiment of the present disclosure, the arrangement/device may also contain a chamber located distally, which can be expanded to different sizes within the colon, thus producing a relatively large working space near the targeted luminal lesion. The exemplary arrangement/device can be structured to manipulate the tools and/or tool-channels in such a way that distal ends of one or more of such tools and/or channels can operate within or at the chamber, and approach the lesion from multiple or even all directions, and using numerous angles. In addition, at least one tool-channel can accommodate a large diameter tool, for example, a special endoscopic stapler. [0016] In a further exemplary embodiment of the present disclosure, the arrangement/device can further contain a control handle, e.g., at or about its proximal end. The handle can be provided in a similar way and/or shape as handles of other endoscopes', while including further more ports, such as, e.g., tool-channels ports, a balloon guide catheter port, a special lever to control the opening and closing of the device chamber, etc. [0017] According to a still further exemplary embodiment of the present disclosure, the arrangement/device can include and/or utilize particular tools or tool-channels. For example, the distal ends of the particular tools and/or tool-channels can be operated in all directions and within all degrees of freedom using the actuating mechanisms, which can be controlled at or about the proximal ends of the device. The exemplary instruments/tools (e.g., grasper(s), scissor(s), dissector(s), others), which can be inserted in the special tools or tool-channels, may be manipulated (e.g., rotated, moved axially forward and backward, bent at the distal end at any desired angles) by manipulating the tool-channels. [0018] In a further exemplary embodiment of the present disclosure, the arrangement/device can facilitate a lateral and/or multi-directional movements of the instruments/tools, in addition to the axial and rotational movements thereof. Since the exemplary tool-channels can be manipulated independently from the main endoscope and other tool-channels, the instruments/tools can approach the lesion from the different and possibly limitless directions. For example, when the endoscopic instruments/tools approach the lesion from the sides in relation to the main longitudinal axis and, hence, without blocking the endoscopic image, a so-called and well-known in laparoscopy “tri-angulation” can be achieved. The tri-angulation can be a preferable technique for achieving the endoscopic arrangement's/device's improved functionality and safety. Such exemplary methodology can mimic the functionality of well-established surgical operating room environments. The exemplary tool-channels can be advanced in the lumen from the working ports of the multi-lumen tube and/or be at least partially pre-fixed to the element(s) of the associated expandable chamber. The exemplary tool-channels can also be advanced directly into the body lumen (e.g., an intestinal lumen), into the chamber space, and/or initially advanced along the element(s) of the chamber and then further into the body lumen or into the chamber space. [0019] As an alternative according to yet another exemplary embodiment of the present disclosure, the arrangement/device, alternatively to the tool-channels or in combination with the tool-channels, can use conventional and/or articulating instruments/tools with at least two degree of freedom. [0020] In addition, according to a further exemplary embodiment of the present disclosure, a method can be provided for using the exemplary arrangement/device in the body lumen (e.g., colon). For example, using such exemplary method, it is possible to perform a standard colonoscopy and identify a lesion that may not be treated using standard endoscopy and techniques. A balloon guide catheter can be inserted, the balloon inflated and the standard colonoscope (the balloon catheter and inflated balloon are left in place) removed. The balloon guide catheter can be used as a guide-wire to facilitate the insertion of the exemplary arrangement/device. The exemplary arrangement/device can be inserted over the balloon guide catheter, e.g., until the chamber is in the proximity to the lesion. The chamber can be deployed and adjusted to certain dimensions. It is possible to readjust the chamber during the procedure, as needed. Further, an operative area can be cleaned with a provided suction catheter. Further, a proximal balloon, a distal balloon or both proximal and distal balloons can be inflated for the treatment area isolation. Tool-channels can be inserted, followed by or in conjunction with an insertion of the instruments/tools into the tool-channels. It is also possible to manipulate the tool-channels to optimize and facilitate the instruments'/tools' approach to the lesion. Further, a procedure can be performed, for example, closing a colonic perforation, removing a large colon polyp or tumor, stopping a bleeding, closing diverticuli, removing an appendix, treating other body luminal lesions. [0021] Further, exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes. [0022] According to yet another exemplary embodiment of the present disclosure. prior to the structure being expanded, the structure can have at least one partially rigid portion that is expandable to form a non-cylindrically-shaped working area which can be asymmetrical. Further, an endoscopic arrangement can be included that is structured to be provided in the working area, and that can include a further configuration that facilitates an articulation of a tip portion of the endoscopic arrangement within the working area. The further configuration can include a mechanical bending arm which can facilitate the tip portion to be moved within the working area so as to facilitate a visualization of at least one object in the working area. An arrangement can also be provided which is coupled to the structure, and which can provide (i) at least one lumen and/or (ii) at least one instrument there through to reach the working area. For example, a distance between a tip of the arrangement and a distal portion of the structure that is farthest away from the arrangement can be controllable to adjust a shape and/or a size of the working area. [0023] In still another exemplary embodiment of the present disclosure, upon a complete or partial expansion of the structure, the structure can be controllable to have a plurality of shapes. In addition, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes. The structure can have an expanded portion and an unexpanded portion, and form an axes of extension of the device, a first distance to a highest point of the expanded portion can be different than a distance to an non-expanded portion. For example, the first distance can be greater than the second distance. The structure can be controllable to adjust the first distance, while maintaining the second distance approximately the same. Further, in an non-expanded state, the configuration can be controllable to provide an articulation thereof in a plurality of directions. [0024] According to a further exemplary embodiment of the present disclosure, a first arrangement can be provided at a distance from the configuration and the anatomical structure(s). In addition, a second arrangement can be provided between the first arrangement and the configuration, and can have at least one lumen that is connected to the first arrangement. Further, a third arrangement can be provided which may be structured to move through the lumen at or near the anatomical structure(s), and which can be configured to be provided in the structure. The lumen(s) can comprise a multi-channel tube, and the structure can be structured to be movable through the multi-channel tube and rigidly connected thereto so as to limit or reduce a movement of the structure with respect to the multi-channel tube. At least one movable camera and an illumination arrangement can be provided within or near the configuration, and movable through the multi-channel tube. At least one movable vacuum catheter and/or irrigation catheter can be provided within or near the structure, and movable through the multi-channel tube. [0025] In one exemplary embodiment, the lumen(s) can comprise a tube channel and/or a tool channel, which is/are movable therein. The tool channel can be axially movable, rotatable, and/or bendable, and can include at least one wire which is configured to bend the tool channel. A distal end of the tool channel can be configured to reach any point inside or near the structure. The tool channel can include at least one wire which can be usable to bend the tube or the tool channel at least in one direction and in at least at one angle which is between 0 and 180 degrees. For example, a distance between the working channel and the structure can be controllable by moving at least one wire in the working channel toward and/or away from the structure. An endoscope can be provided within or near the configuration, and movable through the multi-channel tube to reach the working space. The endoscope can include an image sensor provided on a flexible shaft to visualize at least one portion of the tissue(s). [0026] According to yet a further exemplary embodiment of the present disclosure, the structure can have at least one flexible strip or at least one wire and/or two or more flexible strips or wires. At least one of the strips or wires can have a pre-formed shape to provide the desired geometry of the working space. In addition, at least one balloon can be provided or two or more balloons. At least one of the balloons can be an asymmetric shape and/or a symmetric shape. The balloon(s) can be positioned proximal to the structure. According to one exemplary variant, a first balloon and a second balloon can be provided, where the first balloon is provided distally in relation to the structure, and the second balloon is provided proximally in relation to the structure. The structure can be composed of wires and/or a mesh. Such wires/mesh, prior to being expanded, can have (i) at least one partially rigid portion, (ii) upon a partial or complete expansion thereof, can be controllable to have a plurality of shapes, and/or (iii) can be controllable to provide the working space multiple shapes and/or multiple sizes. [0027] These and other objects, features and advantages of the exemplary embodiment of the present disclosure will become apparent upon reading the following detailed description of the exemplary embodiments of the present disclosure, when taken in conjunction with the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0028] Further objects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying figures showing illustrative embodiments of the present disclosure, in which: [0029] FIGS. 1 a and 1 b , are schematic cross-sectional illustrations of an exemplary embodiment of an arrangement/device comprising a multi-lumen extrusion tube, and multiple tubes inside one large tube in accordance with the present disclosure; [0030] FIG. 2 a is a perspective view of an exemplary embodiment of the arrangement/device according to the present disclosure comprising which includes a nitinol strips chamber in an open position; [0031] FIG. 2 b is a perspective illustration of the arrangement/device of FIG. 2 a with the chamber formed by flexible strips in a closed position; [0032] FIG. 2 b is a side view of the arrangement/device of FIG. 2 a with the chamber formed by flexible strips in another position; [0033] FIG. 2 d is a side view of the arrangement/device of FIG. 2 a with an overtube covering the chamber that is in the closed position according to an exemplary embodiment of the present disclosure; [0034] FIG. 2 e is a side view illustration of the arrangement/device of FIG. 2 a with a scope that is provided in one of the working channels and facilitating a field of view therefor according to another exemplary embodiment of the present disclosure; [0035] FIG. 3 is a perspective view of another exemplary embodiment of the arrangement/device according to the present disclosure which includes the chamber made from two metal strips; [0036] FIG. 4 is a side cross-sectional view of an exemplary embodiment of the arrangement/device according to the present disclosure which includes the chamber made from two asymmetric balloons; [0037] FIG. 5 is a perspective view of another exemplary of another exemplary embodiment of the arrangement/device according to the present disclosure which includes the chamber made from one asymmetric balloon together with the balloon guide catheter; [0038] FIG. 6 is a perspective view of another exemplary of still another exemplary embodiment of the arrangement/device according to the present disclosure which includes the chamber made from metal wires braid; [0039] FIG. 7 is a perspective view of a further exemplary of yet another exemplary embodiment of the arrangement/device according to the present disclosure which includes the nitinol strips chamber with two blocking balloons at both sides; [0040] FIG. 8 is a side view of another exemplary of yet a further exemplary embodiment of the arrangement/device according to the present disclosure which includes the chamber with cameras; [0041] FIG. 9 a is a right side perspective view of another exemplary of a further exemplary embodiment of the arrangement/device according to the present disclosure which includes a particular handle; [0042] FIG. 9 b is a left side perspective view the exemplary arrangement/device of FIG. 9 a; [0043] FIG. 10 is a perspective view of yet another exemplary of yet another exemplary embodiment of the arrangement/device according to the present disclosure which includes a vacuum catheter; [0044] FIG. 11 is a perspective view of yet another exemplary of another exemplary embodiment of the arrangement/device according to the present disclosure which includes a tool-channel; [0045] FIG. 12 are different illustration of a preferred embodiment of still another exemplary of another exemplary embodiment of the arrangement/device according to the present disclosure which includes a tool-channel elevator; and [0046] FIG. 13 a perspective view of yet another exemplary of another exemplary embodiment of the arrangement/device according to the present disclosure which includes the tool-channels inside the chamber thereof. [0047] Throughout the figures, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components or portions of the illustrated embodiments. Moreover, while the subject disclosure will now be described in detail with reference to the figures, it is done so in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described exemplary embodiments without departing from the true scope and spirit of the subject disclosure as defined by the appended claims. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS [0048] According to one exemplary embodiment of the present disclosure, a device, an arrangement and a method can be provided for treatment of, e.g., conditions associated with body lumen(s) or/and cavities, for example, gastro-intestinal conditions, including but not limited to a gastrointestinal perforation, bleeding, large polyps or/and tumors, diverticuli, appendix, and others. [0049] The exemplary embodiments of the arrangement/device according to the present disclosure can provide various functions, which may be the same and/or similar to the surgical functions provided in the surgical operating room, therefore, thus representing a miniature operating room within a lumen (e.g., of a body), such as, e.g., colon and allowing to replace a major surgery, e.g., an open abdominal surgery. [0050] For example, as shown in FIGS. 2 a and 2 b , the exemplary embodiment of the arrangement/device 1 according to the present disclosure can provide an endoluminal chamber which can also be at least partial enclosure, such as, e.g., an endoluminal colon or an intra-colon chamber/enclosure, and include various maneuverable operating instruments and/or tools 11 within the chamber 10 . The exemplary arrangement/device 1 can be inserted after one or more relevant lesions is/are identified, e.g., during standard colonoscopy. A particular balloon guide catheter 4 , e.g., such as described in U.S. Provisional Patent Application Ser. No. 61/247,605 filed on Oct. 1, 2009, or Mega-channel such as Minos Inc. Mega-channel, can be used to facilitate an insertion of the exemplary arrangement/device 1 . [0051] According to certain exemplary embodiments of the present disclosure, the arrangement/device 1 can be a particularly-designed endoscope, such as, e.g., a colonoscope. As shown in FIGS. 9 a and 9 b , according to certain exemplary embodiments, the arrangement/device 1 can include, e.g., an exemplary handle 20 (see FIGS. (see FIGS. 9 a and 9 b ), an exemplary multi-lumen tube 30 (see FIGS. 1 a , 1 b , 3 , 7 , 8 and 13 ), and an exemplary expandable chamber 10 (see FIGS. 5, 7, 10 and 13 ). In addition, the arrangement/device 1 can include standard and particular exemplary instruments/tools 11 (see FIGS. 8, 12 and 13 ) and/or exemplary tool channels (see FIG. 13 ). [0052] As indicated herein above, the exemplary arrangement/device 1 can include the multi-lumen tube 30 . Such exemplary multi-lumen tube 30 can be made from a single extrusion polymer tube 31 having multiple lumens {see FIG. 1 a }, and/or made in a standard endoscopic equipment configuration using a collection of single or multi-lumen tubes 32 of different sizes that are enclosed by a single, large, flexible tube 33 (see FIG. 1 b ). External and internal tubes can be simple polymer tubes and/or reinforced tubes or braided tubes, as known in the art. The external tube 33 can have a diameter that is large enough to contain all inner tubes 32 provided for the exemplary arrangement/device 1 . The exemplary multi-lumen tube 30 can include at least one lumen, and, e.g., possibly 2 to 4 or more lumens for 2 to 4 or more exemplary instruments/tools 11 and/or tool-channels 40 , and possibly additional lumens, for example, for a air insufflation 34 , water irrigation 35 , vacuum 36 , lumen for wiring and/or fibers for cameras and illumination 37 , lumen for a balloon guide catheter 4 , lumen for chamber expansion control 38 , and/or lumen for proximal balloon inflation 39 , as shown in the exemplary embodiment of FIG. 1 b. [0053] For example, according to particular exemplary embodiments of the present disclosure, the arrangement/device 1 can contain a distal chamber 10 that can be expanded to different sizes inside the colon, thus likely creating relatively large or sufficient working space near the lesion to be treated. The exemplary chamber 10 can provide a space for manipulations of multiple tools and / or tool-channels in such a way that several tools can approach the lesion from all sides and directions, as shown in, e.g., FIGS. 3, 7, 8 and 13 . The exemplary multi-lumen tube 30 , e.g., having a diameter between 10 mm to 40 mm, can accommodate at least one tool-channel, which can in turn accommodate, e.g., a non-standard instrument, for example, an endoscopic stapler, both having a sufficient size for a particular purposes thereof. [0054] According to one exemplary embodiment of the present disclosure, the exemplary chamber 10 can be constructed from at least one, and possibly two or more flexible metal strips, fibers or wires 12 , which can be made from a flexible material, such as, e.g., Nitinol, as shown in FIGS. 2 a -2 e and 3 . These exemplary strips, fibers or wires can be composed of other materials as well, including but not limited to surgical plastic or other materials. The exemplary strips, fibers or wires 12 can be substantially straightened (or slightly-to-moderately bent as needed during steering the device through the lumen) when the chamber 10 (providing a working space) is in non-deployed position (see FIGS. 2 a and 2 d ), and are substantially bent when actuated by a control lever 23 in the handle 20 , hence, enlarging the chamber 10 and creating a larger working space inside the colon, as shown in FIGS. 2 b , 2 c , 2 e and 3 . For example, pushing or pulling the exemplary strips, fibers or strips 12 can be performed with a tube 19 that can slide in the lumen 38 by pulling and/or pushing the tube 19 proximal end lever 23 in the handle 20 , as shown in FIGS. 2 a - 2 e, 3 , 9 a and 9 b. Further, the guide catheter 4 can be inserted inside the tube 19 . The exemplary strips 12 can be covered by a soft polymer cover to avoid possible inner colon tissue damage. [0055] According to an exemplary embodiment of the present disclosure, as shown in FIGS. 2 a -2 e , the chamber 10 it can be deflected by pulling on the exemplary strips, fibers or wires 12 , or the chamber 10 can be opened when the exemplary strips, fibers or wires 12 are pushed forward from the handle 30 . In thus manner, the exemplary strips, fibers or wires 12 increase working space with in the chamber 30 to facilitate the anatomical structure to be pulled into the chamber 10 by other instruments/tools 11 being manipulated from the handle 30 , as described in further details herein, and shown in, e.g., in FIG. 8 . [0056] Further, as shown in FIGS. 2 c and 2 e , the exemplary strips, fibers or wires 12 can be covered with a protective cover portions 70 so as to reduce damage being caused by the exemplary strips, fibers or wires 12 when they are actuated to expand the chamber 10 (i.e., which causes the exemplary strips, fibers or wires 12 to push on the surrounding tissue). As shown in FIG. 2 d , the arrangement/device 1 can also include an overtube 65 which can be pushed forward toward the front of the arrangement/device 1 so as to cover the collapsed chamber 10 (e.g., to facilitate insertion and removal and containing the specimen), and pulled back to prepare for the chamber 10 for its expansion. FIG. 2 e shows an illustration of the arrangement/device 1 of FIG. 2 a with a scope 60 (including a camera and at least one light illuminating source) that is provided in one of the working channels 40 and facilitating a field of view 54 for positioning and propelling the exemplary arrangement/device 1 . [0057] When the instrument 1 reaches the desired position within the body, the scope 60 can be retracted inside the chamber 10 , e.g., via the working channel 40 to facilitate visualization inside and/or near the chamber 10 . According to another exemplary embodiment of the present disclosure, an articulating scope (which can perform similar functions as that of the scope 60 ) can be provided through one or more of the working channels 40 into the chamber 10 . Such articulating scope can be configured to illuminate and/or provide images of the anatomical structure and tools inside and/or near the chamber 10 . The articulating scope can have a distal portion that can rotate in 360 degrees and bend to provide an end part thereof so as to illuminate and visualize any portion of the anatomical structure and the tools inside and/or near the chamber 10 at any angle. [0058] In another exemplary embodiment of the present disclosure, as shown in FIG. 7 , the strips 12 can be proximally connected to a first cap 14 , which can be made from a solid material. The first cap 14 can have multiple holes for most or all lumens 32 . The strips 12 can also be distally connected to a second cap 15 which can be smaller in diameter than the first cap 14 , to facilitate a passage of large specimens, for example, polyps into the area of the chamber 10 . The distal second cap 15 can include a hole for insertion of the balloon guide catheter 4 . Alternatively or in addition, the exemplary chamber 10 can be made from two asymmetrical balloons 5 , 16 , as shown in the exemplary embodiment of FIG. 4 . For example, the balloons 5 , 16 can create space for the chamber 10 and the exemplary instruments/tools 11 when inflated. Alternatively or in addition, the exemplary chamber 10 can be provided using the proximal balloon 16 and the distal balloon 5 , being connected to one another via their attachment to the balloon guide catheter 4 , as shown in FIG. 5 . Further alternatively or in addition, the exemplary chamber 10 can be provided by a braided metal wire net 17 having an opening 18 at desired location, as shown in FIG. 6 . [0059] In another exemplary embodiment of the present disclosure, at least one, and possibly two or more balloons can be used with the chamber 10 that is made from strips 12 made from a bendable material (e.g., metal). The exemplary balloon(s) 5 , 16 can assist in blocking and/or isolating the chamber 10 from the rest of the colon, hence, minimizing and/or preventing the inflow and outflow of liquids and solids from and/or to the chamber 10 , while the exemplary strips 12 can provide a substantially rigid and stable working space and facilitate treatment of the lesion. For example, as shown in FIG. 7 , the first symmetric or asymmetric balloon 16 can be provided in proximal to the chamber 10 or the position of the strips 12 . The second balloon 5 can be provided at the position that is distal to the strips 12 . Alternatively, the second balloon 5 that can be connected to the guide catheter 4 . [0060] According to still another exemplary embodiment of the present disclosure, the arrangement/device 1 can include at least one camera and an illumination apparatus to provide sufficient light to the area of interest. For example, camera or cameras and illuminating component can be movable or fixed in the arrangement/device 1 , for example, to the chamber 10 . In one exemplary embodiment shown in FIG. 2 e , the scope/front camera 50 can be used to facilitate the insertion of the arrangement/device 1 into the colon. Referring to FIG. 8 , e.g., at least one, two or more additional and possibly fixed cameras 51 can be positioned so to facilitate image capture at a location of the lesion. Exemplary field views 54 of the cameras 51 can overlap, and such overlap may facilitate visualization if one or more instruments/tools blocks or adversely affects view of one of the cameras. For example, illumination can be provided by a variety of ways, e.g., by LEDs 52 , 53 . Exemplary front LEDs 52 can be used for the front camera 50 , and in-chamber LEDs 53 can be used for the illumination in or at the chamber 10 . Alternatively or in addition, a conventional flexible endoscope, having distal bendable section, can be used instead of or together with the fixed camera(s) 51 and illumination via the LEDs 52 , 53 . [0061] As shown in FIGS. 9 a and 9 b , the exemplary arrangement/device 1 according to a further exemplary embodiment of the present disclosure can include a control handle 20 at or about its proximal end. The exemplary handle 20 can have similar shape and configuration with respect to other conventional endoscope's handles, while likely having additional channel ports and actuators than standard endoscope. For example, the ports in the handle 20 can include at least one, and possibly 2-4 or even more ports for the tool-channels 21 , balloon guide catheter port 22 and particular lever 23 to control the opening and closing of the chamber 10 . Additional ports can include, but not limited to, a luer port 24 for a proximal balloon inflation, and a port 26 of a vacuum catheter 25 or an irrigation catheter. The handle 20 can include switches 27 , 28 for air insufflations, water irrigation and vacuum activation, as well as switch (not shown) for switching camera(s) between frontal and inner locations. [0062] As illustrated in FIG. 10 , the exemplary arrangement/device 1 according to a still further exemplary embodiment of the present disclosure can include a vacuum catheter with a bent tip 25 , inserted in a vacuum lumen 36 through a vacuum port 26 . The vacuum catheter can operate as a standalone (as describe herein), and/or may be inserted into tool channel 40 and deflect. Further, the vacuum catheter can be manipulated to reach all or most areas inside and around the chamber 10 , hence, providing an access for elimination of liquids and solids from and around the chamber 10 . In another exemplary embodiment of the present disclosure, the chamber 10 can include bendable and steerable section, which can be actuated at the lever 23 , which when pulled, the instrument 1 is articulated, and when pushed, the chamber 10 is opened (or increased in size). Thus, movements of the exemplary arrangement/device 1 in the colon can be facilitated. According to a further exemplary embodiment, a locking mechanism can be provided which can , e.g., rotate one or more times (e.g., counterclockwise or counter-clockwise) to lock the lever 23 . [0063] According to still another exemplary embodiment of the present disclosure, the exemplary arrangement/device 1 can include the instruments/tools 11 and/or tool-channels 40 , as shown in FIG. 11 . When the exemplary instruments/tools 11 are inserted in the tool channels 40 , distal ends 41 thereof change the position(s) and/or shapes of the instruments/tools 11 , for example, rotated, axially moved, bent at desired angles, whenever the position and shape of the associated tools channels 40 are changed, as shown in FIG. 12 . The tool channels 40 can be actuated and manipulated at or about proximal end of the exemplary arrangement/device of the present disclosure. The described maneuverability of the tool-channels 40 , for example, their distal ends 41 provide and/or facilitate multidirectional and multiangular approach to the target lesion. [0064] For example, the tool-channels 40 can include at least one, and preferably two, three or more lumen tubes 42 , which can be made of polymer, possibly having high torque-ability, low friction, connected at or about their distal ends to an additional section 41 , which can have “elevators” 43 . The exemplary polymer tube(s) 42 can be reinforced with other materials to change its/their structural or/and functional properties. The elevator 43 can be a flexible bendable section, made, e.g., from a laser cut nitinol tube 44 , and/or actuated, e.g., bent, using one or two metal wires 45 . The instruments/tools 11 can be inserted in the first (e.g., relatively large) lumen of the tube 42 , and the wire 45 can be inserted in the second (e.g., relatively small) lumen of the tube 42 . [0065] As shown in FIG. 13 , the ability of the tool-channel tubes 42 to move, independently or simultaneously, axially (e.g., pushing, pulling directions), rotate and bend using the elevator 43 , facilitates the instruments/tools 11 or/and the tool-channels 40 in reaching any point within and around the chamber 10 , and can provide possibly an unlimited range of instrumental freedom within the working space. For example, as shown in FIG. 11 , the tool channel 40 can include one or more handles 46 connected to the tube 42 at or about a proximal side of the tube 42 , and can be used for a manipulation of the elevator 43 , and utilize a port 47 for an insertion of the exemplary instrument/tool. [0066] 11 . The exemplary tool-channel handle 46 can include a slider or knob 48 which can be used to actuate, e.g., pull and release a wire 45 , as shown in FIG. 12 . Any standard tool(s) can be used with the exemplary tool-channel(s) 40 . Alternatively or in addition, articulating tools having maneuverable distal ends, e.g., with at least two degrees of freedom, can be used. [0067] According to yet a further exemplary embodiment of the present disclosure, a method for implementing the exemplary arrangement/device 1 according to the present disclosure can be provided. Such exemplary method can be utilized as follows: [0000] i. Perform a standard colonoscopy and identifying a lesion that may not be treated using standard endoscopy and techniques. ii. Insert a balloon guide catheter, inflating the balloon and removing the standard colonoscope (the balloon catheter and inflated balloon are left in place). The balloon guide catheter can be used as a guide-wire to facilitate the insertion of the exemplary arrangement/device 1 . iii. Insert the exemplary arrangement/device lover the balloon guide catheter, until the chamber is in the proximity to the lesion. iv. Deploy and adjust the chamber 10 of the exemplary arrangement/device 1 to preferred dimensions. Readjust the chamber 10 during the procedure as needed. v. Clean an operative area with a provided suction catheter. If desired, inflate a proximal balloon, a distal balloon or both proximal and distal balloons for the treatment area isolation. vi. Insert the tool-channels. vii. Insert the instruments/tools into the tool-channels. Manipulate the tool-channels to optimize and facilitate the instruments/tools approach to the lesion. viii. Perform a procedure, e.g., closing a colonic perforation, removing a large colon polyp or tumor, stopping a bleeding, closing diverticuli, removing an appendix, treating other body luminal lesions. [0068] The foregoing merely illustrates the principles of the present disclosure. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. For example, more than one of the described exemplary arrangements, radiations and/or systems can be implemented to implement the exemplary embodiments of the present disclosure. It will thus be appreciated that those skilled in the art will be able to devise numerous systems, arrangements and methods which, although not explicitly shown or described herein, embody the principles of the present disclosure and are thus within the spirit and scope of the present disclosure. In addition, to the extent that the prior art knowledge has not been explicitly incorporated by reference herein above, it is explicitly being incorporated herein in its entirety. All publications referenced herein above are incorporated herein by reference in their entireties.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a filmless dental radiography system, and more particularly to a filmless dental radiography system that includes an intraoral radiation sensor that interfaces with the Universal Serial Bus (USB) port of a desktop, tower or portable (such as laptop or notebook) computer. 2. Description of the Related Art Dentists and oral surgeons typically use x-radiation ("x-rays") to obtain images of their patients' teeth, mouths and gums to aid in diagnosis and treatment. In traditional oral and dental radiography, a cartridge containing a piece of photographic film is placed in the patient's mouth, for example behind a patient's tooth, and an x-ray beam is projected through the tooth and onto the film. The film, after being exposed in this manner, is developed in a dark room or a closed processor using special chemicals to obtain a photographic image of the tooth. More recently, the field of filmless dental radiography has emerged. In filmless dental radiography, an x-ray beam is still projected through the patient's tooth, but no photographic film is used. Instead, an electronic sensor is placed in the patient's mouth behind the tooth to be examined. The electronic sensor may include a charge-coupled device (CCD), an active pixel sensor (APS) array or any other filmless radiation sensor. The x-rays pass through the tooth and impinge on the electronic sensor, which converts the x-rays into an electrical signal. The electrical signal is transmitted over a wire to a computer, either directly or though a module containing intermediate processing circuitry. The computer then processes the signal to produce an image on an associated output device, such as a monitor or a printer. Filmless dental radiography offers several advantages over traditional film-based radiography. Most importantly, the electronic sensor is much more sensitive to x-rays than is film, allowing the dosage of x-rays to the patient to be lowered by as much as 90%. Also, the image of the tooth is generated by the computer almost instantaneously, thus eliminating the entire developing process, including the use of potentially harmful chemicals. In addition, because the images are generated electronically, they can be stored electronically in a computer database. Examples of filmless dental radiography systems include those described in U.S. Pat. No. 4,160,997 to Robert Schwartz and U.S. Pat. No. 5,434,418 to David Schick. Filmless dental radiography systems typically utilize a standard desktop computer, such as an IBM or IBM compatible type personal computer. To provide a data path between the electronic sensor (or the intermediate module) and the computer's CPU, some conventional systems use the computer's Peripheral Component Interconnect (PCI) bus. The PCI bus, a internal 32-bit local bus that runs at 33 MHz and carries data at up to 133 megabytes per second (MBps). Other conventional filmless dental radiography systems use the computer's Industry Standard Architecture (ISA) bus, an 8- or 16-bit internal bus that carries data at up to 8.33 MBps. Each of these buses may act as a suitable interface between the sensor and computer. While generally good for their intended applications, systems that use the computer's PCI or ISA bus have certain drawbacks. Most notably, the PCI and ISA buses are internal, and require that a specially designed circuit board be installed inside of the computer. The need for such a board increases the cost and reduces the reliability of the overall system. Moreover, installing such a board is a time-consuming task that may only be performed by someone trained in the installation of computer peripherals. In particular, the installation requires the physical opening of the computer's housing, the clearing of any casing or wiring that may be in the way of the slot, the insertion of the card into the slot and the re-assembly of the housing once the insertion is complete. These are not tasks that are easily performed by the typical user of a filmless dental radiography system, such as a dentist, endodontist or oral surgeon. In addition, many practitioners use a single sensor in conjunction with several computers, such as having a separate computer associated with each patient chair in the practitioners office. For such a scenario to be practical, a separate board must be installed into each of the computers, further increasing the cost of the overall system. Moreover, the number of PCI and ISA slots available in a desktop or tower computer is limited. Installing a circuit board in a given slot to support a filmless dental radiography system precludes the use of that slot for some other type of peripheral device. Once all slots for a given bus are used, no more peripherals can be interfaced through that bus, unless one of the installed boards is removed and replaced with the board for the new peripheral. Such removal and replacement is not something that can be conveniently done on a regular basis. Further still, portable computers, such as laptops and notebooks, generally are not provided with PCI or ISA slots. Accordingly, a conventional filmless dental radiography system cannot be used with such portable computers. Very recently, desktop, tower and portable computers are being made available with a Universal Serial Bus (USB) port. The USB is a serial 12 megabit per second (Mbps) channel that can be used for peripherals. The USB is a token-based bus. In particular, the USB host controller broadcasts tokens on the bus and a device that detects a match on the address in the token responds by either accepting or sending data to the host. The host also manages USB bus power by supporting suspend/resume operations. Unlike the PCI and ISA buses, the USB port does not require the use of a specially designed circuit board inside the computer. Accordingly, once the appropriate software has been installed, a peripheral simply need be plugged into the USB port to be ready for operation. In addition, one device can be unplugged and another plugged in without changing the hardware configuration of the computer. Also, the USB port is "hot swappable," meaning that a first peripheral may be unplugged and a second peripheral plugged in without turning off and restarting the computer. In addition, the USB uses tiered star topology, allowing up to 127 different peripherals on the bus at a time. Further still, not only desktop and tower computers have USB ports; laptop and notebook computers are provided with USB ports as well. While the USB port has received a great deal of attention from those designing computer peripherals as of late, no one has heretofore thought to use it as an interface for a filmless dental radiograph system. This is primarily because the USB is much slower than the PCI or ISA buses. More particularly, the theoretical maximum bandwidth of the USB is 12 Mbps (1.5 MBps), several times slower than the 8.33 MBps ISA bus and orders of magnitude slower than the 133 MBps PCI bus. And because many peripherals might be connected to the USB, no single peripheral can expect to realize the full range of the 1.5 MBps maximum theoretical bandwidth of the USB, making the practical bandwidth of the USB substantially less. Accordingly, the USB is not believed to be fast enough to support the data flow requirements of a scientific sensor, such as a filmless dental radiography sensor. For example, in a conventional filmless dental radiography system analog data might be read-out of the sensor at a rate on the order of 4 million pixels per second (Mpps), converted on a real-time basis to digital data by an analog-to-digital converter (ADC) in an intermediate module and provided on a real-time basis to the computer's PCI or ISA bus. If a 16-bit (2 byte) ADC is used, an interface that can carry data at 8 MBps is required for such data transfer. This is several times greater than even the 1.5 MBps theoretical maximum bandwidth of the USB. Even a system which reads-out data at rate of 1 Mpps and uses a 12-bit (1.5 byte) ADC requires 1.5 MBps of bandwidth, the theoretical maximum bandwidth of the USB, and would strain or exceed the capabilities of the USB. Some computer peripherals, such as digital cameras, have relatively low image quality requirements, and contend with the relatively smaller of the USB by simply reading-out data more slowly. This approach, however, is not suitable for a scientific sensor such a filmless dental radiography system, in which the quality of the image is paramount. In particular, a slower read-out rate results in a greater accumulation of dark signal (i.e. that part of the image data created by thermally generated electron-hole pairs) in the sensor, which results in turn in greater image degradation. Such results, while perhaps acceptable for a digital camera, are completely unacceptable for a scientific sensor such as a filmless dental radiography system, which must produce images of clarity sufficient to facilitate the diagnosis and treatment cavities, dental roots and the like. There is a need, therefore, for a filmless dental radiography system that solves the inherent problems associated with the PCI and ISA buses by exploiting the advantages of using the USB port, while at the same time overcoming the obstacles that have heretofore prevented the USB port from being used for scientific sensors. SUMMARY OF THE INVENTION One object of the present invention is to provide a filmless dental radiography sensor that does not exhibit the disadvantages of using the PCI or ISA buses that are discussed above. Another object of the present invention is to provide a filmless dental radiography system that uses the computer's USB port as the interface between the sensor and the computer. In accordance with one aspect of the present invention, a filmless dental radiography system is provided which includes an intraoral sensor that outputs image data and a computer having a universal serial bus port that receives data. The image data output by said intraoral sensor are input to the computer through the universal serial bus port. In accordance with another aspect of the present invention, a filmless dental radiography system is provided which includes an intraoral sensor that outputs image data, a computer having a universal serial bus port that receives data and a universal serial bus cable between the intraoral sensor and the computer with the universal serial bus cable including a universal serial bus plug that couples with the universal serial bus port. The image data output by the intraoral sensor are input to the computer over the cable and through the universal serial bus port. In accordance with another aspect of the present invention, an intermediate circuit is interposed between the sensor and the computer which includes a processing circuit that controls the reading-out of image data from the intraoral oral sensor and a memory circuit in which the image data read-out of the intraoral sensor are stored. In accordance with yet another aspect of the present invention, the processing circuit retrieves the image data stored in the memory, processes the image data and output the image data to the computer through the universal serial bus port, at a rate slower than the rate at which the image data were read-out from the intraoral sensor. In accordance with yet another aspect of the present invention, the processing circuit is a specially programmed reduced instruction set computer. In accordance with yet another aspect of the present invention, the intraoral sensor includes a charge coupled device. In accordance with yet another aspect of the present invention, the intraoral sensor includes an active pixel sensor array. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block level illustration of one embodiment of the filmless dental radiography system of the present invention. FIG. 2 is a cross-sectional illustration of the USB cable used in the filmless dental radiography system of the present invention. FIG. 3 is a functional block diagram of one embodiment of the remote board of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of a filmless dental radiography system according to the present invention is depicted in FIG. 1. As can be seen, the system includes an electronic sensor 1, including a connector 1a, a remote board 2 and a computer 4, with the remote board 2 and the computer 4 being connected through the computer's USB port 4a. The electronic sensor 1 may comprise a CCD, an APS array or some other solid state device capable of converting electromagnetic radiation into electrical signals. The electronic sensor 1 might also comprise on top of the CCD, APS array or other solid state device a scintillator layer which converts x-rays into visible light. The computer 4 may be any conventional desktop, tower, laptop or notebook computer that is equipped with a USB port 4a and a corresponding USB channel. In addition to the USB port 4a, the computer 4 is equipped with various known software modules that support the USB channel, such as USB host controller software, and a known USB hardware interface. The computer 4 is either connected to or has built in one or more input devices, such as a keyboard 5 and a mouse 6, and one or more output devices, such as a monitor 7 and a printer 8. These devices allow the user to control the operation of the system, and to view the dental images that the system creates. The computer might also include or be connected to some type of storage device (not shown), such as a hard drive, for permanent storage of the images in patient files. Image data flows from the electronic sensor 1 to the USB port 4a through the remote board 2. The remote board 2 and USB port 4a are physically connected through a standard USB cable 3 which includes a USB plug 3a that couples with the USB port 4a. The USB cable 3, illustrated schematically in FIG. 2, is a four-wire bi-directional cable that includes a power line V, a data plus line D+, a data minus line D- and a ground line GND. This cable carries serial image data from the remote board 2 to the USB port 3a, and also carries serial control instructions from the USB port 3a to the remote board 2, such as for example tokens broadcasted by the USB host controller software. One preferred embodiment of the remote board 2 present invention is depicted in FIG. 3. In this preferred embodiment, the remote board 2 includes all of the processing circuitry necessary to, among other things, effect x-ray signal integration by the electronic sensor 1; read-out analog data from the electronic sensor 1 at the high rate required for a scientific sensor; convert the analog data to digital data; store that digital data; process that data into a form suitable for transmission over the USB channel; and transmit the processed data to the computer 4 via the USB port 4a at a rate slow enough for the USB channel to support. The remote board 2 also includes a power supply module that couples with the V and GND lines of the USB to receive power and provide the appropriate voltages to the electronic sensor 1 and the other components on the remote board 2. The core of the remote board 2 in this preferred embodiment is a reduced instruction set computer (RISC) chip 31. An example of an appropriate RISC chip is the SL11-R-USB Controller (manufactured by ScanLogic Corporation, 4 Preston Court, Bedford, Mass. 01730, http//:www.scanlogic.com), a 48 Mhz, 16-bit RISC with a built-in 3K×16 BIOS Mask ROM, a 1.5 K×16 internal SRAM, a 2 Mbyte SRAM/DRAM memory interface port, a 12 Mbps (1.5 MBps) USB port, an 8- or 16-bit direct memory access (DMA) or input/output (I/O) port, a serial EEPROM (SEEPROM) interface and four high-speed pulse width modulation or programmable output channels. The full description of the SL11-R-USB RISC can be found in the "SL11R/SL16/SL11P2USB/SL08/SLEPP2USB Hardware Specification," published by ScanLogic Corporation. Under the control of firmware specific to the type of electronic sensor that the system incorporates, the RISC chip 31 receives signals from and interfaces with the USB host controller software, and produces signals that control all aspects of the electronic sensor's operation, including data read-out and x-ray signal integration. The remote board 2 includes two memory blocks--a random access memory DRAM 38 for storing the image data read-out of the sensor and a read-only memory SEEPROM 39 for storing system initialization programs, test programs, USB support programs and configuration data. DRAM 38 may be accessed by the RISC chip 31 either via software or via DMA. A complex programmable logic device (CPLD) 32 decodes signals from RISC chip 31 to provide specific control signals to electronic sensor 1 and to other components on the remote board 2. More particularly, CPLD 32 generates digital signals that are provided to a digital-to-analog converter (DAC) 34, which DAC 34 in turn converts those digital signals into analog voltages suitable for effecting x-ray signal integration by and read-out of electronic sensor 1. These analog voltages are provided to electronic sensor 1 via a buffer 35. The analog data read-out of electronic sensor 1 are provided to an input filter 36 (which may be, for example, a fourth-order Bessell low-pass filter), and from there to analog-to-digital converter (ADC) 37. ADC 37, under the control of CPLD 32, converts the analog data retrieved from electronic sensor 1 into digital data that can be processed by RISC chip 31. To ensure that the data corresponding to a captured image is retrieved before a unacceptable amount of dark signal can accumulate, the reading-out of the sensor is performed at a relatively high rate, such as for example rates on the order of 1 Mpps or more. These read-out rates, in conjunction with an ADC of 16-, 12- or even 8-bits, however, result in data transfer rates that are either close to or exceed the theoretical 1.5 MBps maximum bandwidth of the USB, and are therefore too fast for the USB to support. Accordingly, the data retrieved from electronic sensor 1 are stored temporarily in DRAM 38. After being stored in DRAM 38, the data are read-out by RISC chip 31 and assembled into a USB-compatible format. The RISC chip 31 might also be programmed to perform other required or desirable processing operations as well, such as for example dark signal subtraction. The assembled and processed data are then transmitted under the control of RISC chip 31 to the USB port 4a of the computer 4. Due to the bandwidth constraints of the USB, this transmission occurs at a rate slower than the rate at which the image data were read-out of electronic sensor 1, and which the USB can comfortably support. For example, if the filmless dental radiography system is the only peripheral connected to the USB port 4a, the transfer will take place at rates on the order of 750 kilobytes per second (KBps). If on the other hand several peripherals are connected to the USB port 4a, such as via a hub, the data transfer will take place at rates slower than that. In any event, the rate of transfer of the data over to the USB port 4a will have no effect on the quality of the image, since the data is being not being read-out of the sensor at the slower rate, but rather out of the DRAM 38. The unique approach of the present invention allows data to be read-out of the electronic sensor 1 at a fast rate to prevent the accumulation of an unacceptably high amount of dark signal, while at the same time exploiting the advantages of the computer's USB without exceeding or straining its bandwidth limitations. It is to be understood that the above description and drawings are illustrative of the present invention and detail contained therein are not to be construed as limitations thereon. Changes in components, procedure and structure may be made without departing from the scope of the present invention as defined in the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS Related subject matter is disclosed in a further U.S. patent application filed concurrently herewith, by the same applicant, Ser. No. 14/564,976, titled “TOILET SEAT AND TOILET LID LIFTER AND REMOTE TOILET FLUSHER”, the entire content of which is hereby incorporated by reference for all that is taught to provide greater detail or to describe additional aspects, but is in no way meant to limit or contradict the disclosure set forth herein or the construction of the appended claims. BACKGROUND OF THE INVENTION Field of the Invention Various exemplary embodiments relate to devices for raising and lowering the seat of a commode or toilet. Description of Related Art Generally, toilet seats and/or lids vary greatly, from simple handles that are connected to the toilet seat, to complex mechanized and powered units. The former type does not totally eliminate unsanitary hand contact, nor does it eliminate possible arm, hand and back strain associated with manual operation. Mechanized and/or powered units often require complicated installation and/or permanent additions or modifications to the toilet, plumbing, and surrounding structure that are costly to manufacture and maintain. SUMMARY OF THE INVENTION In accordance with an exemplary embodiment, a toilet seat lifting device includes a pedal base, a pedal, a seat bracket, and a lifter lever. The pedal is pivotally connected to the pedal base. The seat bracket is mechanically connected to the pedal so that movement of the pedal induces movement of the seat bracket. The lifter lever is connected to, and extends outwardly from, the seat bracket. In accordance with another exemplary embodiment, a toilet seat lifting device includes a pedal base, a mounting bracket, a pedal, a seat bracket, and a lifter lever. The pedal base has a first portion and a second portion extending from the first portion. The mounting bracket extends from the pedal base and has a slot. The pedal pivotally connects to the pedal base and has a bottom and a toe lip. The seat bracket is mechanically coupled to the pedal so that downward movement of the pedal induces movement of the seat bracket in a first direction and upward movement of the pedal induces movement of the seat bracket in a second direction. The lifter lever is connected to, and extends outwardly from, the seat bracket. In accordance with additional exemplary embodiments is a combination toilet and toilet seat lifting device. The toilet has a toilet base, a toilet seat connected to the toilet base by a seat hinge, and a tank. The lifting device includes a pedal base, a mounting bracket, a pedal, a seat bracket, and a lifter lever. The mounting bracket extends from the pedal base and connects to the toilet base. The pedal pivotally connects to the pedal base. The seat bracket connects to the seat hinge and is coupled to the pedal so that movement of the pedal induces movement of the seat bracket. The lifter lever is connected to the seat bracket and is positionable under the toilet seat so that application of a force to the pedal causes movement of the toilet seat. In accordance with a further exemplary embodiment, a device for raising or lowering a toilet seat includes a foot pedal disposed proximate a surface supporting a toilet. A linkage member mechanically attaches to the foot pedal at a first end thereof. An operating assembling mechanically attaches to said linkage member at a second end thereof. The operating assembly has a lifter for raising the toilet seat when the foot pedal is depressed and a closer for closing the toilet seat when the foot pedal is raised. Various exemplary embodiments include a manually operated device to facilitate the desired raising and lowering of a toilet seat and lid through the application of downward and upward force applied to a single pedal. According to various embodiments, when the pedal is depressed by the foot the seat is raised. Upward force on the pedal lowers the seat. BRIEF DESCRIPTION OF THE DRAWINGS The above aspects and features of the present invention will be more apparent from the description for the exemplary embodiments of the present invention taken with reference to the accompanying drawings, in which: FIG. 1 is a perspective view of a lifter device connected to a toilet in accordance with an exemplary embodiment; FIG. 2 is perspective view of the lifter device and toilet of FIG. 1 with the lifter biasing the toilet seat in a raised configuration; FIG. 3 is a side elevational view of the lifter device and toilet in a first exemplary configuration where a connector rod is connected in a first position and with a depiction of a user's foot; FIG. 4 is a side elevational view of the lifter device and toilet of FIG. 3 with the user biasing the toilet seat into the raised configuration at a less than vertical position; FIG. 5 is a side elevational view of the lifter device and toilet in a second exemplary configuration where a connector rod is connected in a second position and where the toilet seat is raised past a vertical position; FIG. 6 is a top plan view of the lifter device and toilet of FIG. 1 ; FIG. 7 is a side sectional view of the seat bracket taken about line 7 - 7 . FIG. 8A is a perspective view of the lifter device of FIG. 1 removed from the toilet; FIG. 8B is an enlarged view of the circled area of FIG. 8A around an indent; FIG. 8C is an enlarged view of the circled area of FIG. 8A around the rear of the seat bracket; and FIG. 9 is a perspective view of the pedal base and seat bracket mounted to the toilet with the pedal and connector rod removed. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS In accordance with the exemplary embodiments, a toilet seat lifter 10 includes a pedal base 12 that rests on the floor next to a toilet 14 . The term toilet seat may be used herein to refer to any toilet seat toilet lid, or combination thereof. The pedal base 12 includes a first portion 16 and a second portion 18 . In the illustrated exemplary embodiment, the first portion 16 is a rectangular, horizontal plate having a pair of substantially flat, planar surfaces, with a bottom surface in contact with a floor, and the second portion 18 is a rectangular, vertical plate extending from the first portion 16 away from the floor. The second portion 18 extends from the first portion 16 at a substantially right angle, although any angle can be used depending on the configuration of the lifter 10 and the toilet 14 . The first and second portions 16 , 18 may be unitarily formed or separately connected to one another. Different configurations for the pedal base 12 may be used, for example any rectilinear shape, curvilinear shape, or various combinations thereof, to conform to different toilets, meet size requirements, or for other utility and design considerations. The pedal base 12 may be made from a plastic, metal, ceramic, or composite material, or any combination thereof. In certain embodiments, the pedal base 12 is made from any stiff, lightweight material. The pedal base 12 is connected to a mounting bracket 20 by one or more mechanical fasteners, for example by one or more bolt and wing nut combinations 22 . The mounting bracket 20 includes a first part 24 and a second part 26 . In the illustrated exemplary embodiment, the first part 24 is a pentagonal, horizontal plate having a pair of substantially flat, planar surfaces, and the second part 26 is a rectangular, vertical plate extending from the first part 24 towards the floor. The first part 24 has a slot for receiving one or more fasteners to connect to the toilet 14 . In an exemplary embodiment the slot receives the existing mounting hardware from the base of the toilet. The second part 26 extends from the first part 24 at a substantially right angle, although any angle can be used depending on the configuration of the lifter 10 and the toilet 14 . The first and second parts 24 , 26 may be unitarily formed or separately connected to on another. Different configurations for the mounting bracket 20 may be used, for example any rectilinear shape, curvilinear shape, or various combinations thereof, to conform to different toilets, meet size requirements, or for other utility and design considerations. In various exemplary embodiments, the mounting bracket 20 is unitarily formed with the pedal base 12 . If the mounting bracket 20 is unitarily formed with the pedal base 12 , the second part 26 may be omitted and the first part 24 extends directly from the pedal base 12 . The mounting bracket 20 may be made from a plastic, metal, ceramic, or composite material, or any combination thereof. In certain embodiments, the mounting bracket 20 is made from metal and is coated, for example with paint, to help prevent corrosion. A pedal 28 is pivotally connected to pedal base 12 , for example via a pedal hinge 30 or other suitable pivotal connection. The pedal includes a bottom 32 , a toe lip 34 extending from the bottom 32 , and an extension arm 36 . In the illustrated exemplary embodiment, the bottom 32 is a substantially planar member with a bottom surface facing the pedal base 12 and an opposite top surface for receiving a user's foot. The toe lip 34 has a first curved section extending from the bottom 32 and a concave second curved section at its free end. The toe lip 34 receives upward force applied by a user's foot. The extension arm 36 extends from the pedal 28 and includes a first end, a second end, and an intermediate twist or S-shaped curved section. The bottom 32 , toe lip 34 , and extension 36 may be unitarily formed or separately connected in any combination. Different configurations for the pedal 28 may be used to conform to different toilets, meet size requirements, or for other utility and design considerations. The pedal 28 may be made from a plastic, metal, ceramic, or composite material, or any combination thereof. In certain embodiments, the pedal 28 is made from any stiff, lightweight material. The pedal 28 is mechanically attached to a first end of a linkage member and an operating assembly having a lifter and a closer is connected to the second end of the linkage member. According to an exemplary embodiment, the linkage member is a connector rod 38 that connects the extension arm 36 and a seat bracket 40 . The seat bracket 40 includes a first section 42 and a second section 44 . The first section 42 includes a first aperture A and a second aperture B. The connector rod 38 may be selectively connected to the first aperture A or the second aperture B by a user. One or more mounting claws 46 extend from the second section 44 . The mounting claws 46 connect to the seat hinge 48 . In accordance with the exemplary embodiment, the mounting claws include a first hook portion and a first tab spaced by a slot for receiving the seat hinge 48 . The mounting claws 46 are unitarily formed with the seat bracket 40 or separately connected. Although the exemplary mounting claws 46 are configured to engage a variety of seat hinges 48 , removable mounting claws 46 may be utilized to allow for connections to different types of seat hinges 48 . The size, shape, and configuration of the mounting claws 46 may be varied to conform to different toilets, meet size requirements, or for other utility and design considerations. In the illustrated exemplary embodiment, the first section 42 is a rectangular, vertical plate and the second section 44 is a rectangular, vertical plate extending from the first section 42 at a substantially right angle. When connected to the seat hinge 48 , the first section extends outside of the toilet 14 . Different configurations for the seat bracket 40 may be used to conform to different toilets, meet size requirements, or for other utility and design considerations. The seat bracket 40 and connector rod 38 may be made from a plastic, metal, ceramic, or composite material, or any combination thereof. In certain embodiments, the seat bracket 40 and connector rod 38 are made from metal and are coated, for example with paint, to help prevent corrosion. A lift lever 50 is moveably connected to the seat bracket 40 , for example to the first section 42 . The lift lever 50 is positionable underneath a toilet seat 52 and is locked in place via a notch or an indent 54 in the seat bracket 40 . In various exemplary embodiments, the lift lever 50 is connected to the seat bracket 40 by a fastener with enough tolerance to allow sufficient movement of the lift lever 50 , for example a bolt or rivet 9 . The lift lever 50 is capable of movement in a horizontal plane and a vertical plane. In various other exemplary embodiments, the lift lever 50 may be connected to the seat bracket 40 by a hinge, for example a living hinge. In the illustrated exemplary embodiment, the lift lever 50 is an elongate, substantially rectangular member, although different configurations may be used to conform to different toilets, meet size requirements, or for other utility and design considerations. The lift lever 50 may be made from a plastic, metal, ceramic, or composite material, or any combination thereof. In certain embodiments, the lift lever 50 is made from metal and is coated, for example with paint, to help prevent corrosion. In operation, the pedal base 12 is placed next to the toilet 14 and the mounting bracket 20 is connected to the base of the toilet 14 . The seat bracket 40 is connected to the toilet seat hinge 48 and the lift lever 50 is positioned under the toilet seat 52 . It may be necessary to temporarily loosen the existing toilet seat hinge 48 bolts upon initial installation of the seat bracket 40 to allow room in the toilet hinge for 48 the mounting claws 46 . In an exemplary embodiment, the toilet hinge 48 bolts are tightened with the mounting claws 46 in place to allow space for the mounting claws 46 to be easily inserted or removed in subsequent installation and removal of the seat bracket 40 , for example without further adjusting or loosening the seat hinge 18 . When connected to the seat hinge 48 , the first section 42 of the seat bracket 40 extends outside the edge of the toilet 14 . The pedal 28 is connected to the seat bracket 40 by connector rod 38 connected to either aperture A or B. As depicted in FIG. 3 , and in accordance with various exemplary embodiments, when a user steps on the pedal 28 and applies downward pressure, the pedal 28 is pivoted towards the pedal base 12 , moving the extension arm 36 and the connector rod 38 downward, pulling down the first section 42 of the seat bracket 40 , and pivoting the seat bracket 40 on the toilet hinge 48 . As the seat bracket 40 pivots, the lift lever 50 raises the toilet seat 52 to a raised position. When the toilet seat is raised, a user may move their foot upwards, applying force to the toe lip 34 and lifting the pedal 28 . Upward movement of the pedal 28 moves the extension arm 36 and the connector rod 38 upward, which pushes up the first section 42 of the seat bracket 40 and moves the lift lever 50 back towards the toilet 14 . The rotation of the seat bracket 40 to its initial position causes it to engage the toilet seat 52 and move the toilet seat 52 to an initial or lowered position. As shown in FIG. 4 , placement of connector rod 38 in aperture A causes the lift lever 50 to lift the toilet seat 52 to a less than vertical position so that the toilet seat 52 returns to the lowered position upon removal of the force from user's foot. As shown in FIG. 5 , placement of connector rod 38 in aperture B lifts the toilet seat 52 to a beyond vertical position, for example with the toilet seat 52 resting against the toilet tank 56 , so that toilet seat 52 remains raised when force from a user's foot is removed. The seat 52 is then lowered by a user moving the pedal 28 upward. Accordingly, the various exemplary embodiments described provide a toilet seat lifting and lowering device using a single pedal 28 and a user option for the seat 52 to automatically return to a lowered position or for the seat 52 to return to a lowered position by application of a force to the toe lip 34 . The single pedal 28 is capable of both raising and lowering a toilet seat 52 . The various exemplary embodiments described also provide a device capable of being installed and removed for ease of use and maintenance (e.g., cleaning) of the toilet 14 . In various exemplary embodiments, the lifter device 10 is configured to retro-fit to existing toilet seats. The lifter device 10 allows user to avoid/minimize physical skin contact (disease transmission) and prevent strenuous effort/exertion of back, spine, shoulders etc. required to manually lower and raise a toilet seat 52 . In various exemplary embodiments, the pedal base 12 is not mounted to the toilet 14 . For example, the pedal base 12 could be sufficiently heavy to provide stability and prevent movement during use. In another alternative embodiment, the pedal base 12 is secured to the floor, for example using a mechanical connection such as fasteners, or an adhesive connection such as tape or glue. Although the exemplary embodiments depict a lifter 10 configured to be positioned on the right side of the toilet 14 , the lifter 10 may be configured to be positioned on the left side of the toilet 14 or configured to be selectively positioned on either side of the toilet 14 by a user. The foregoing detailed description of the certain exemplary embodiments has been provided for the purpose of explaining the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. This description is not necessarily intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Any of the embodiments and/or elements disclosed herein may be combined with one another to form various additional embodiments not specifically disclosed. Accordingly, additional embodiments are possible and are intended to be encompassed within this specification and the scope of the appended claims. The specification describes specific examples to accomplish a more general goal that may be accomplished in another way. As used in this application, the terms “front,” “rear,” “upper,” “lower,” “upwardly,” “downwardly,” and other orientational descriptors are intended to facilitate the description of the exemplary embodiments of the present invention, and are not intended to limit the structure of the exemplary embodiments of the present invention to any particular position or orientation. Terms of degree, such as “substantially” or “approximately” are understood by those of ordinary skill to refer to reasonable ranges outside of the given value, for example, general tolerances associated with manufacturing, assembly, and use of the described embodiments.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to improvements to a conventional kettle, tea kettle, steamer, or covered spouted pot. 2. Description of the Prior Art Apparatus exists in the prior art primarily for use in the heating of rooms, namely, space heaters. Space heaters are free standing fireplace versions of heaters fueled by wood, coal, fuel, pellets, gas, propane, heating oil and the like. These space heaters are used today to conserve energy and to efficiently heat rooms and other spaces within homes. These space heaters are also used in restaurants to decorate foyers and waiting areas. The water heated in the prior art apparatus serves to humidify the room and surrounding areas and prevent drying of the sinuses and nasal passages. Thus, the steam produced from the heating and boiling of water in a vehicle on a space heater or free standing fireplace offsets the dry heat produced by many room heaters. One problem with the prior art kettles and pots used to provide humidity is that those available are not adapted to be placed on tope of a space heater or free standing fireplace or stove. Accordingly, the consuming public has resorted to various containers which open upward and rapidly deplete the water content and often result in burning and overheating of the receptacle. Another problem with these open receptacles is that the volume of steam released upwards is so great that sometimes damage is done to the ceiling of the room in which they are used and to the piping or portion of the structure above the ledge or flat surface on which these open top vehicles are placed for heating. Another problem with these open top vehicles and receptacles is that oftentime they do not have handles. Thus, when a user attempts to remove a receptacle to replenish the water therein burning sometimes occurs or spillage. Sometimes these improvised containers are made of a breakable material and in the process of removing the container for refilling they are dropped and broken because of their being overheated and there being no handle available to facilitate picking up and moving the container. In 1903 Doggett received U.S. Pat. No. 748,052 which disclosed a receptacle preferably formed with a vertical wall. The vertical wall is used to facilitate attachment of another receptacle with a mating flat wall. In 1927 Jacobs received U.S. Pat. No. 1,633,022 which disclosed a carrier frame or skeleton construction adapted to receive several sectional buckets or receptacles adapted with flat walls to nest together in the carrier frame. The patent suggests that one of the sectional buckets may be removed for the purpose of replenishing the contents thereof without disturbing the other flat wall buckets in the carrier frame. In FIG. 2 is disclosed a bucket with an open top and one side flattened. In 1926 Adams was issued U.S. Pat. No. 1,577,781 for a cooking utensil made of a plurality of segmental sections. In FIG. 5 there is shown one section of two flat walls and a spout which opens upward. In 1909 Geig was issued U.S. Pat. No. 927,521 for a cooking utensil comprising a plurality of receptacles in a carrier skeleton with at least one of the receptacles having one side flattened and further having a handle and a top. In 1956 Quinones was issued U.S. Pat. No. 2,738,893 for double bucket, namely, a pair of similar receptacles detachably interconnected each with a flat side wall, a flat bottom and open top, and semicylindrical side wall. The art further progressed in 1987 when Horvath was issued U.S. Pat. No. 4,651,900 for a "Dual Compartment Serving Pot". This pot included a pair of pot halfs having substantially flat inner walls. The flat sided pot halfs each has an opening fully covered by a lid member. The patent further disclosed a spout extending above the movable lid and opening upwards. A somewhat similar container was patented in 1989 by Bouldin, U.S. Pat. No. 4,802,406. There is disclosed a pair of containers each having a flat side wall and a semicylindrical side wall as well as an upwardly open top. The device shown in the prior art patents address the broad concept of a container having a flattened side wall for the distinct purpose of juxtaposing or attaching that side wall to another receptacle having a mating flattened side wall. However, the prior art does not address utilizing a flattened side wall for the purpose of placement and retainment on a narrow ledge or the weighting of the bottom and side wall to shift the center of gravity to or near the flattened side wall and away from the front of the ledge. Further, the prior art collectively discloses receptacles which either provide a lid which completely seals the receptacle or an opening which opens upward and does not address a structural means for directing steam from liquids boiled in the receptacle in a direction other than upwards. SUMMARY In accordance with one aspect of the invention a kettle is provided with a flattened side wall contiguous to a cylindrical side wall and flat bottom and a spout which is directed not vertically but horizontally and perpendicularly away from the flattened side wall. The kettle is adapted with a larger aperture and covering lid for putting therein and a handle for easily mobilizing the kettle. OBJECTS OF THE INVENTION It is therefore an object of the invention to provide a kettle capable of standing on a narrow ledge or flat space on top of a space heater, free standing fireplace or wood burning stove or the like. It is another object of the novel invention to provide a vehicle for heating water to provide humidity in a room heated by a space heater, free standing fireplace, stove, or the like which although it has one flattened side wall otherwise retains the look and charm of a usual and customary kettle or pot. It is yet another object of the invention to provide a novel structure for a tea kettle wherein the spout deflects steam in a horizontal forward direction and thereby reduces rusting and wetting of surfaces above and adjacent customary kettles placed on stoves or free standing fireplace inserts and ledges. It is yet a further additional object of the invention to provide a novel kettle wherein the flattened rear surface and the bottom are weighted by being made thicker, for example, than the remainder of the kettle, namely the semicylindrical wall and top such that the center of gravity of the kettle is in the vicinity of the juncture between the flat side wall and the bottom. It is also an additional object of the invention to provide a novel kettle whereby the weighting of the bottom and the flattened side wall acts in conjunction with a handle for lifting the kettle whereby the weighting of the bottom counterbalances the weighting of the flattened side wall to provide a center of gravity in the vertical plane of the kettle handle. It is yet another additional object of the invention to provide a novel means for counterbalancing the additional weight of the vertical flattened side wall with a removable flat item such as a trivot attachable to the bottom of the kettle so as to counterbalance the weight of the flattened side wall to assure that the kettle maintains its vertical orientation when lifted by its handle. BRIEF DESCRIPTION OF THE DRAWINGS The drawings illustrate the best mode presently contemplated for carrying out the essential features novel to the invention. In the drawings: FIG. 1 is a front view of a novel kettle formed according to the invention; FIG. 2 is a left side view of the novel kettle of FIG. 1; FIG. 3 is a rear view of the novel kettle of FIG. 1; FIG. 4 is a top view of the novel kettle of FIG. 1; and, FIG. 5 is a bottom view of the novel kettle of FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENT As shown in FIG. 1, a novel kettle 10 according to the invention includes a nonflat semicylindrical side wall 12 contiguous with a flat bottom 14. Extending from the nonflat side wall 12 is a spout 16 which extends upward and then horizontally to a horizontally opening aperture 18. The kettle 10 has a larger aperture 20 covered by a removable lid 22. A handle 24 is attached to the kettle 10. Referring now to FIG. 2 there is shown the kettle 10 with its semicylindrical side wall 12, flat bottom 14 and a contiguous flattened or flat rear wall 26. The aperture 18 is shown extending perpendicularly away from the flat side wall 26. Detailed aspects of the spout 16 are shown wherein it extends upwards vertically and then horizontally away from the side wall 26. Note that the thickness of the flattened vertical side wall 26 is illustrated as "a" and the thickness of the bottom 14 is illustrated as "b" whereas the thickness of the remainder of the kettle 10 is illustrated generally as a thickness "c". In the preferred embodiment "b" is greater than "a", and "c" is less than "a" or "b". The specific dimensions of "a", "b" and "c" may change and may be selected from a variety of parameters. The thickness for the parameter "b" is always greater than the thickness of the parameter "a" and is selected such that the center of gravity for the kettle is substantially within a plane illustrated as p--p'. this plane p--p' is the plane defined by the lateral aspect of the handle 24 within the position illustrated in FIGS. 1 and 2. A typical example of the kettle 10 according to the invention is when the bottom of the tea kettle is defined by one half of an elipse divided along its great axis wherein the greater axis is 8.5 inches and the minor axis is 8 inches. Further, the distance from the bottom 14 to the uppermost point of the spout 16 is 5.5 inches, the height of the flattened side wall 26 is 4.5 inches, and the parameters "a", "b" and "c" are 4.5 millimeters, 5 millimeters, and 4 millimeters, respectively. The distance from the top of the nonflat surface of the kettle 10 shown in FIG. 2 to the uppermost aspect of the handle 24 with the foregoing parameters is preferably 3.5 inches and the handle preferably weighs between about 1 ounce and 5 ounces. Shown in FIG. 3 is a rearview of the kettle 10 from the aspect of the flat wall 26. The kettle 10 is preferably made of a material selected from the group consisting of iron, brass, aluminum, copper, stainless steel, or an enameled aspect of the first four. As shown in detail in FIG. 3 lid 22 is adapted to removably seal the aperture 20. As illustrated the aperture 20 is substantially greater than the aperture 18 at the end of the spout 16. Further, the thickness of the bottom 14 is illustrated as substantially greater than the thickness of the nonflat side wall 12 shown in FIG. 3 as having a thickness "c". There is shown within and contained within the kettle 10 a quantity of a liquid, for example, water 30. In FIG. 3 the bottom 14 is required to be of sufficient thickness such that it may be separated into two parts (not shown), namely a bottom which is an integral portion of the kettle 10 and another removable part which attaches to the bottom of the kettle by any number of means such as for example clamps, or a tongue and groove slot arrangement. Such a removable bottom may conform to the shape of the bottom of the kettle 10 as shown in FIG. 5 or may assume a variety of other shapes for decorative or design purposes. It may be separately usable as a trivet in addition to its function to counterbalance to insure the center of gravity of the kettle 10 falling within the plane p--p' wherein the handle 24 is located. In FIG. 4 there is shown a top view of the kettle 10 wherein the lid 22 is shown sealing the large aperture 20. The spout 16 is shown extending upwards and then horizontally to an opening 18 which points perpendicular away from the side wall 26. The handle 24 is shown pivoted towards the nonflat side wall 12. The handle 24 is retained in brackets 32 and 34 forming an integral part of the kettle 10. A portion 36 of the handle 24 is preferably made of a heat insulating material to facilitate picking up the kettle 10 with minimal conduction of heat to the portion 36 from the kettle 10. Finally, there is shown in FIG. 5 a bottom view of the kettle 10 wherein the nonflat side wall 12 is shown contiguous with the bottom 14 and the flat side wall 26. Further illustrated is the thickness "a" for the side wall 26 and the thickness "c" for the nonflat side wall 12. The illustration is such that the thickness "a" is greater than the thickness "c". It is to be understood that further modifications and alterations of the embodiment shown and alternative embodiments of the kettle and/or steamer described for this invention will be apparent for those skilled in the art in view of this description. Accordingly, this description is to be viewed as illustrative only of the preferred embodiment at this time and for the purpose of teaching those skilled in the art the manner of carrying out the invention including the importance of the center of gravity of the novel invention being located in the plane of the handle. It is to be understood that the forms of the invention herewith shown and described including the thick bottom, whether by detachable trivet or not, are the presently preferred embodiments. Various changes may be made in the shape, size and arrangement of the parts. Equivalent elements or materials may be substituted for those illustrated and described herein, parts may be reversed, and certain features of the invention may be utilized independently of the use of other features. All of this as would be apparently to one skilled in the art after having the benefit of this description and thus the inventor in this instrument relies upon the doctrine of equivalents for his claims as set forth below, to wit:

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to display racks for displaying a plurality of inanimate objects and more particularly to a display rack comprised of a plurality of interconnected supports having a tongue-and-groove connection system along top and bottom edges thereof so that a plurality of the supports can be releasably interconnected for varying the size of the display rack. [0003] 2. Description of the Relevant Art [0004] Display racks have been a common form of displaying a plurality of relatively small inanimate objects such as golf balls, figurines, petite glassware, spools, or the like, for many years. The racks typically include a plurality of support shelves on which the objects being displayed are positioned. [0005] Some support racks are enclosed in a box-like structure and may even include a glass cover over the front to protect the objects being displayed. The racks are typically made in various sizes to accommodate different numbers of objects being displayed. [0006] One problem with such display racks is that a fixed number of locations are defined on the display rack and as a collection of objects grows, additional box-like structures must be purchased to add to an original collection. The display rack itself in the prior art has not been adjustable in size, i.e., they are of a fixed size and they cannot be added to or subtracted from. [0007] Accordingly, there is a need in the field of display racks for a rack that can be varied in size so that an increase or decrease in the number of objects being displayed can be accommodated without buying additional complete display racks. SUMMARY OF THE INVENTION [0008] The display rack of the present invention consists of a plurality of substantially identical component parts that can be releasably interconnected to create larger or smaller display racks. Each component of the display rack includes a vertical plate-like member having a connection system that is complementary to the connection system on an adjacent component so that a display rack may begin with a single component but additional components can be added interconnecting one component to an overlying or underlying component. [0009] Each component has one of various systems for displaying objects depending upon the type of object to be displayed. For example, the back plate may have a plurality of horizontally projecting pins to display spools of thread or the like. The back plate may also support a horizontal shelf on which objects can be positioned and the shelves themselves may have indentations, holes, upstanding pins, embossments or the like for positively positioning the objects to be displayed. [0010] By way of example, a shelf on a back plate may include a plurality of aligned indentations in which a golf ball can be releasably seated so that the ball does not easily roll off the shelf and will remain in position for display. The spacing of the indentations is predetermined so that the aesthetic of the display is as desired. [0011] The top or uppermost component in an aggregate of such components defining a display rack in accordance with the invention may have a top flange or overhang along the top edge thereof for decorative purposes. Similarly, the bottommost support component may have a flange or horizontal projection along its lower edge which may or may not serve also as a shelf for displaying objects. [0012] The bottommost component may be stood on its own on a horizontal support surface such as a table or the like. Normally, however, a selected number of the components would be interconnected and hung on a vertical support surface such as a wall by providing a connection system on the rear of the uppermost component for receipt of a nail or other hanger on the wall. [0013] Other aspects, features and details of the present invention can be more completely understood by reference to the following detailed description of a preferred embodiment, taken in conjunction with the drawings and from the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is an isometric looking at the front of a display rack in accordance with the present invention having two releasably interconnected components. [0015] FIG. 2 is an isometric similar to FIG. 1 showing the display rack of FIG. 1 with an additional intermediate display component. [0016] FIG. 3 is an exploded isometric of the display rack shown in FIG. 2 . [0017] FIG. 4 is a section taken along line 4 - 4 of FIG. 2 . [0018] FIG. 5 is a fragmentary front elevation of the rack of FIG. 2 . [0019] FIG. 6 is a fragmentary rear elevation of the rack of FIG. 2 . [0020] FIG. 7 is an isometric of a display rack in accordance with the present invention showing various systems for supporting objects to be displayed. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0021] A display rack 10 in accordance with the present invention is shown in FIG. 1 to include two component supports 12 and it will be appreciated with the description following that any number of component supports could be incorporated into the display rack. When assembled as shown in FIG. 1 , the two component supports define a completed rack with two display shelves 14 for inanimate objects 16 such as golf balls. The display rack shown in FIG. 1 has an uppermost support component 12 u and a bottommost support component 12 b even though as seen in FIG. 2 , for example, an intermediate support component 12 i could be positioned between the uppermost and bottommost components to add a third display shelf 14 . [0022] Referencing FIG. 3 , the three component supports 12 shown in FIG. 2 are separated. The intermediate support component 12 i can be seen to include a plate-like back 18 that has a horizontal groove 20 routed or otherwise formed in a front face thereof near the bottom edge of the back plate. A relatively thin display shelf 14 has its rear most edge inserted into the groove and is retained therein either frictionally, with adhesive or with other suitable means. The shelf itself is provided with a plurality of indentations 22 formed in a top surface thereof at equally spaced locations with the indentations being provided to releasably retain inanimate objects 16 to be displayed in the rack at the predetermined locations. For example, in the embodiment shown in FIGS. 1-6 , the indentations 22 form a segment of a sphere so that a golf ball or other spherical object could be placed or seated in an indentation to keep the ball from rolling off the shelf. [0023] Immediately below the shelf 14 on the front face of the support component 12 , a tongue-and-groove connector 24 is formed so that a forwardly projecting tongue 26 is defined by a rearwardly projecting groove 28 immediately thereabove and a lower edge 30 of the back plate 18 . The tongue and the groove are defined by substantially horizontal surfaces 32 and substantially vertical surfaces 34 but as is probably best appreciated by reference to FIG. 4 , the substantially horizontal surfaces are in reality sloped slightly downwardly and rearwardly from the front face of the back plate toward the rear of the back plate. The substantially vertical surfaces are similarly slightly inclined upwardly and rearwardly from the front face of the back plate toward the rear face. It will therefore be appreciated a front lip 36 is defined at the upper front edge of the tongue 26 and an inner corner 38 in the bottom rear edge of the groove 28 . The lip is positioned higher than the inner corner for a reason to be explained hereafter. [0024] A similar tongue-and groove connection 24 is formed near the top edge of the back plate in its rear surface so that the tongue 26 overlies the groove 28 but again the substantially horizontal surfaces 32 are inclined slightly rearwardly and downwardly while the substantially vertical surfaces 34 are inclined slightly rearwardly and upwardly identically to those in the front face of the back plate. The tongue-and-groove connection in the top of the back plate is therefore complimentary to the tongue-and-groove connection in the bottom of the back plate so that, while not illustrated, the tongue-and-groove at the top of one intermediate support component 12 i can be received in the tongue-and-groove connection of a next adjacent upper identical intermediate support component 12 i such that the back plates of both intermediate support components are co-planer. As will be appreciated, any number of intermediate support components can therefore be interconnected and suspended from each other with the rearwardly and downwardly inclined surfaces in the tongue and the groove of each connector encouraging a positive interconnection by gravity. Further, if one were to try to horizontally remove an intermediate component from an interconnected intermediate component, it could not be easily separated unless the lowermost component was pulled upwardly and forwardly which is restricted by the display shelves 14 . This is due to the fact that the above-defined lip of the tongue 26 is higher than the inner corner of the groove 28 . If the support components are made of a soft wood or plastic they can be snapped together or apart but typically the support components are interconnected or supported by sliding one component longitudinally of the other. [0025] Looking again at FIG. 3 , an uppermost component 12 h of the display rack 10 is shown to be very similar to an intermediate component 12 i in that it has a lower tongue-and-groove connector 24 along the lower edge of the back plate 18 and in the front face thereof and the connector is immediately beneath a shelf 14 mounted on the back plate as described above with the shelf having a plurality of indentations 22 . The top edge of the back plate in the uppermost support component, however, does not include a tongue-and-groove connector as in the intermediate components. A horizontal overhang plate or flange 40 , however is secured to the top edge of the back plate of the uppermost component along its rear edge for decorative purposes so that the overhang plate or flange 40 overlies the shelf 14 on the uppermost support component of the display rack. [0026] Similarly, the bottommost component 12 b of the display rack 10 has a tongue-and-groove connector 24 formed along its top edge in the rear face thereof but no tongue-and-groove connector along the bottom edge. A bottom wall or flange 42 of the bottommost support component, however, is connected to the bottom edge of the back plate 18 of the bottommost component so that the bottom wall or flange projects forwardly and horizontally from the lower edge of the back plate. Rather than having a shelf in the bottommost component, the bottom wall or flange 42 serves as a shelf in the display rack and has a plurality of aligned indentations 22 formed therein. [0027] It will be appreciated from the above that the display rack 10 will preferably include an uppermost support component 12 u , a bottommost support component 12 b and one or more intermediate support components 12 i that are interconnected with each other and/or to an uppermost support component or a bottommost component depending upon the number of components desired for the display rack. As mentioned above, the tongue-and-groove connectors 24 on the support components cooperate with each other in supporting and interconnecting the support components so they can best be separated by sliding one component longitudinally of the other. [0028] It will also be appreciated that any number of intermediate support components 12 i can be provided as by adding or subtracting from an existing display rack. Further, as shown in FIG. 1 , there does not need to be an intermediate support component, but rather the bottommost component 12 b can be connected directly to the uppermost component 12 u if a two-shelf display rack were desired. [0029] As will be appreciated, a display rack 10 with multiple components is vertically suspendable from a vertical surface such as a wall. When suspending the display rack from a vertical support surface, one or more notches 44 ( FIG. 6 ) could be formed in the rear of the uppermost component 12 u to receive a nail or other fastener projecting from the vertical support surface. If the recess was of the type illustrated in FIG. 6 where it included a relatively large circular opening 46 near its bottom to receive the head of, for example, a screw and a relatively thin neck 48 projecting upwardly therefrom smaller than the head of the screw, a very positive interconnection of the display rack with the vertical support surface can be obtained. [0030] While the embodiment shown in FIGS. 1-6 illustrates one form and use of the display rack in accordance with the present invention, the systems incorporated into the display rack for releasably but positively positioning objects being displayed could be varied. [0031] For example, in FIG. 7 , the uppermost component 12 u of the display rack 10 , which is shown as being taller than the intermediate 12 i and bottommost 12 b components, also includes a plurality of horizontally disposed cylindrical pins 50 projecting forwardly from the back plate 18 on which objects such as spools of thread, or the like could be displayed. Also, on the top surface of the shelf 14 of the uppermost component, a pair of rectangular embossments or raised areas 52 are provided which might cooperate, for example, with a recess in the bottom of a figurine that might be displayed on the shelf. On the shelf of the intermediate component 12 i , a plurality of holes 54 are formed through the shelf through which other inanimate objects such as might have a larger upper body than a lower body might be positioned so that the lower body could be dropped through the hole but the larger upper body would be supported above the shelf. On the bottom wall 42 of the bottommost support component 12 b , a plurality of upstanding pins 56 are provided which again, for example, might be used to support spools of thread, yarn or the like or other similar objects for display. [0032] It will be appreciated from the above, that while several embodiments of the invention have been illustrated, it will be evident to those skilled in the art that other variations could be made to the shelves, the bottom wall, or the back plates for displaying objects of different configurations and the invention is not intended to be limited to those few possibilities illustrated. Further, while one particular tongue-and-groove system for interconnecting adjacent support components has been illustrated and has been felt to work very well, other systems might also work for interconnecting the support components in co-planer relationship in any manner so that they are not easily separated. [0033] Although the present invention has been described with a certain degree of particularity, it is understood the disclosure has been made by way of example, and changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.

1a

This is a continuation of application Ser. No. 07/608,954, filed on Nov. 5, 1990, now abandoned. BACKGROUND OF THE INVENTION Prior to the present invention, various compression devices have been known in the art for applying compressive pressure to a patient's limbs in order to increase blood flow velocity. Particularly useful are the SCD (trademark of The Kendall Company, assignee of the present invention) sequential compression devices providing intermittent pulses of compressed air which sequentially inflate multiple chambers in a sleeve, beginning at the ankle and moving up the leg. This results in a wave-like milking action which empties the veins and results in greatly increased peak blood flow velocity, thus providing a non-invasive method of prophylaxis to reduce the incidence of deep vein thrombosis (DVT). These compression devices find particular use during surgery on patients with high risk conditions such as obesity, advanced age, malignancy, or prior thromboembolism. When a DVT occurs, the valves that are located within the veins of the leg can be damaged, which in turn can cause stasis and high pressure in the veins of the lower leg. Patients who have this condition often have swelling (edema) and tissue breakdown (venous stasis ulcer) in the lower leg. It has also been shown that pneumatic compression can be highly effective in the treatment of such edema and venous ulcers. This treatment is usually performed at home on a daily basis. Devices of the foregoing description are disclosed in various patents of which the following are illustrative: U.S. Pat. Nos. 4,013,069 and 4,030,488 issued to James H. Hasty; 4,320,746 issued to Edward J. Arkans and Frank K. Villari; and 4,938,208 issued to John F. Dye, the last-mentioned patent to John F. Dye being particularly directed to units for home treatment. In general, the compression devices of the prior art comprise a sleeve having a plurality of separate fluid pressure chambers progressively arranged longitudinally along the sleeve from a lower portion of the limb to an upper portion. Means are provided for intermittently forming a pressure pulse within these chambers from a source of pressurized fluid during periodic compression cycles. Preferably, the sleeve provides a compressive pressure gradient against the patient's limb during these compression cycles which progressively decreases from the lower portion of the limb, e.g. from the ankle to the thigh. Sequential pneumatic compression devices of the foregoing description applying compression to the lower limb have achieved considerable notoriety and wide acceptance as an effective non-invasive means for preventing deep vein thrombosis and for treating venous stasis ulcers. They function by applying pneumatic compression sequentially and in gradient levels from ankle to thigh for a predetermined time, e.g. 15 seconds, followed by a period of time, e.g. 45 seconds, when no pressure is applied. The particular time period selected is chosen to be optimum for pushing venous blood out of the leg (during the compression cycle) and to allow arterial blood to refill the leg (during the decompression interval). It has recently been discovered that it may also be advantageous to apply pneumatic compression to the foot to provide significant venous blood movement therefrom. For example, U.S. Pat. Nos. 4,702,232 and a division thereof, 4,841,956, of Arthur M. N. Gardner and Roger H. Fox relate to a device for inducing venous-return flow, which device is intended for use on an impaired human leg. In accordance with the teachings of these patents, the cyclical succession of venous pump action which would occur in normal walking is achieved by involuntarily or artificially activating a foot pump followed by artificially induced separate transient operation of a proximal calf pump and then an artificially induced separate operation of a distal calf pump. As disclosed, the pump actions are achieved by providing inflatable bags or cuffs around the foot and upper and lower calf regions, the inflatable cuffs being separately connected by tubes to a fluid pressure supply means. Each cuff is inflated and then deflated before the next cuff is inflated. Moreover, the cuffs are not inflated sequentially from distal to proximal, e.g. the sequence disclosed in the patent of foot pump, proximal calf pump and then distal calf pump which procedure does not encourage an effective pumping of blood from the leg. In contrast thereto, the task of the present invention, stated simply, is to provide an improved compression device which provides more complete venous emptying by applying compression to the plantar venous plexus in the foot as well as sequentially to the leg, thereby more effectively obviating the trapping of blood which can occur in the foot veins, particularly during initial compression, as may be the case with the current sequential compression devices applying no sequential compression to the foot region. BRIEF DESCRIPTION OF THE INVENTION In accordance with the present invention, this task is satisfied in an elegant means by providing a sequential compression device comprising an elongated sleeve having a plurality of inflatable chambers for placement over the foot and a portion of leg, a means for sequentially inflating said chambers in an order with the foot chamber being inflated first and the remaining chambers of the leg subsequently in an arrangement from a distal portion of the leg towards a proximal portion of the leg relative to the heart. A feature of the present invention is that the chambers of the leg are inflated while the foot chamber remains inflated. Another feature of the invention is that the foot chamber propels blood from the foot towards the leg for compression by the inflated leg chambers, thereby enhancing the movement of blood. Yet another feature of the invention is that the chambers may be intermittently deflated. A further feature of the invention is that the inflating means can maintain a baseline pressure in the chambers at all times over which periodic compression cycles occur. Yet another feature of the invention is that the inflating means controls the maximum pressure in the chambers such that at least some of said pressure is decreased toward the proximal portion of the leg. A further feature of the invention is that in the preferred embodiment, the portion of the sleeve defining the foot chamber is a one-piece construction with a portion defining the chambers of the leg. The feature of the invention is that the sleeve is a simplified construction and used for compression of the foot and leg of the limb. Yet another feature of the invention is that the device inflates the sleeve such that the trapping of blood in the limb is minimized. Yet another feature of the invention is that the device inflates the sleeve such that the improvement of blood flow through the limb is maximized while trapping of fluid is minimized. A further feature of the invention is that dynamic control may be maintained over the chambers during inflation to maintain the chambers inflated in desired pattern. Further features will become more fully apparent in the following detailed description of the invention in conjunction with the illustrative drawing and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 is a perspective view of a compression device of the present invention; FIG. 2 is a front plan view, partly broken away, of a sleeve for the device of FIG. 1; FIG. 3 is a plan view of the backside of the sleeve of FIG. 2; and FIG. 4 is a fragmentary sectional view of an inner portion of sleeve of FIG. 2. DESCRIPTION OF PREFERRED EMBODIMENTS Referring now to FIG. 1, there is shown a device generally designated 20 for compressing a patient's limb, such as the leg, as shown. The compression device 20 has a controller generally designated 22 and a pair of elongated sleeves 26 for covering the patient's limbs. The controller 22, which per se comprises no part of this invention, may be of the type disclosed, for example, in U.S. Pat. Nos. 4,013,069 and 4,030,488, incorporated herein by reference, and the controller 22 sequentially passes fluid through a pair of conduits 34 and 35 to the sleeves 26 in order to inflate chambers in the sleeves, as will be discussed below, from a source of fluid through a conduit 28 communicating with the controller 22, and the controller 22 may intermittently connect the inflated chambers of the sleeves 26 to an exhaust or conduit 30. With reference to FIGS. 2-4, the sleeves 26 have a leg portion 40 for covering the leg from the region of the ankle to the thigh, and a foot portion 42 for covering the foot of a patient. The sleeves 26 have a pair of inner fluid impervious sheets 44 and 46 which are joined together along lines 48 by suitable means, such as by heat sealing in order to form chambers in the sleeves 26. Thus, the foot portion 42 has a laterally extending chamber 50 at a location for covering the plantar arch intermediate the ball and the heel of the foot at a location underneath the foot, although the foot chamber 50 may extend partially or entirely around the upper portion of the foot after placement of the sleeve 26, if desired. As shown, the leg portion 40 of the sleeve 26 has a plurality of progressively located chambers 52a, 52b, 52c, 52d, 52e, and 52f extending laterally in the sleeve 26 such that they are raised to cover the ankle, calf and thigh of the leg at a location extending from the ankle to the thigh region of the leg. In a preferred form, the leg chamber 52a-f extend completely around the limb after placement of the sleeve 26. As shown, in a preferred form, the foot portion 42 is of 1-piece construction with a leg portion 40 and sleeve 26 to provide sleeve 26 of simplified construction and reduce cost. The conduits 34 and respective foot chambers 50 and the leg chambers 52a-f in a suitable manner (not shown), such as by the connectors disclosed in U.S. Pat. No. 4,320,746, incorporated herein by reference. If desired, the sleeves 26 may have an inner sheet of suitable flexible material (not shown) covering an inner surface of the sheets 44 and 46 to provide comfort to the limb during the use of the device 20 after placement of the sleeve 26, and may have an outer sheet 58 of a loop material, such as a knit fabric covering an outer surface of the sheets 44 and 46. The sleeves 26 may have elongated strips 62 of a hook material extending along a side of the foot portion 42 and leg portion 40 of the sleeve 26 for a purpose which will be described below. The conduits 34 and 35 may be covered with a suitable tube 64 for the leg portion 40 of the sleeve 26 and the tube 66 of fabric for the foot portion 42 in a manner as disclosed in U.S. Pat. No. 4,320,746, incorporated herein by reference. While not necessary to the practice of this invention, as in prior compression devices of the general description, sleeve 26 may have an elongated opening 32 extending through a knee region 36 of the sleeve, defined by peripheral edges 38 around the opening 32. In addition, as shown, the sleeve 26 may have an elongated opening or cut-out 54 in the knee region 36 extending from one side edge toward a lateral central portion of the sleeve, with the cut-out 54 being defined by peripheral edges 60. As is described with more particularity in U.S. Pat. No. 4,207,875 issued to Edward J. Arkans, the purpose of these openings is to enhance the flexibility of the sleeve in the knee region. Preparatory to use, the sleeves 26 are placed over the limbs of the patient, with the foot portion 42 located over the patient's foot, and the leg portion 40 over the patient's leg. The sleeves 26 are wrapped about the foot and leg, such that the foot portion 42 of the sleeve 26 encompasses the foot, and the leg portion 40 of the sleeve 26 encompasses the leg. In this configuration, the strips 62 of the sleeve 26 may be placed in contact with the outer loop sheet 58 in order to engage the hook strip 62 at an adjustable position on the sheet 58 of loop material in order to secure both the foot portion 42 and leg portion 40 of the sleeve in place in a comfortable and snug position about the patient's limbs. In use, the controller 22 is operated in order to sequentially inflate the foot chamber 50 and leg chambers 52a-f, in an order with the foot chamber being inflated first and the remaining chambers of the leg subsequently in an arrangement from a distal portion of the leg towards a proximal portion of the leg relative to the heart while the foot chamber remains inflated. Thus, the foot chamber 50 is inflated first in order to enhance circulation of blood from the foot into the leg, after which the leg portion 40 of the sleeve is operated in order to sequentially inflate the leg chambers in order with the ankle being inflated first, the calf portion being inflated after the ankle portion, and then the thigh portion being inflated after the calf portion. In this manner, the leg portion 40 of the sleeve 26 enhances the movement or circulation of blood through the legs after the blood from the foot has been circulated into the legs, thereby preventing trapping of blood in the foot, and enhancing blood circulation through the legs in a direction toward the heart. During the sequential inflation of the leg chambers 52a-f of the sleeves 26, the foot chamber 42 remains inflated, and, in a preferred form, each of the more distal chambers of the leg portion 40 also remains inflated during subsequent inflation of more proximal chambers of the leg portion 40 of the sleeves 26, such that each of the chambers of the sleeves 26 remain inflated during compression cycles of device 20. In this manner, the device maintains pressures in the respective chambers during periodic compression cycles, after which cycles the chambers are then deflated. Further, a preferred form the controller 22 controls the maximum pressure in each chamber such that at least some of the pressure is decreased toward the proximal portion of the leg. Thus, according to the present invention, the foot chamber 50 of the foot portion 42 is initially inflated during a compression cycle in order to enhance movement of the blood into the leg of the patient after which the leg chambers 52a-f are sequentially inflated in order to propel the blood from the limbs toward the patient's heart. In this manner, the device 20 prevents trapping of fluid in the patient's limb while materially increasing the rate of blood flow through the limb during operation of the device 20. Stated another way, device 20 of the present invention maximizes the movement of fluid while minimizing the trapping of fluid in the limb in an improved manner. According to the present invention, in a preferred form, the controller sequentially inflates the chambers of the sleeves 26 and retains dynamic control during inflation in order to maintain the chambers inflated in a desired pattern during operation of the device. In this manner, control may be maintained over the inflation pressures in each of the chambers individually during inflation. It will be appreciated that various changes and additions may be made in the device shown in the illustrative drawing without departing from the scope of the invention herein contemplated. For example, while the device has been illustrated to be a unitary sleeve 26 having a leg portion 40 and a foot portion 42, it will be apparent that the leg and foot portions may instead be separate sleeves encompassing the respective limb portions where compression is to be applied. Further, while the preferred compression devices, i.e. the "SCD" device manufactured and sold by The Kendall Company, assignee of the present invention, provide a pressure gradient, it is within the scope of this invention to provide compression patterns which do not. It is also within the scope of this invention to maintain a minimum or base pressure in each of the compression chambers throughout the entire inflation and deflation cycles. This base pressure may be the same in each of the chambers in the sleeve, e.g. on the order of about 10 mm of mercury or, alternatively, it may be the greatest in the foot chamber and then become progressively lower in each successive chamber. For example, the foot chamber may be on the order of 10 mm; the ankle chamber on the order of 8 mm; the calf on the order of 6 mm; and thigh 4 mm. As heretofore alluded to, the patent literature is replete with references to sequential compression devices. In general, any of the modifications described and claimed in these prior patents may be incorporated into the novel device of this invention. For instance, a ventilation chamber may be included, as disclosed in U.S. Pat. Nos. 4,091,804 of James H. Hasty or 4,481,937 of Edward J. Arkans. Other modifications which may be made included, but are not limited to the following: providing concurrent rather than sequential inflation (compression) from a single pulse to apply a gradient from ankle to thigh, as described in U.S. Pat. No. 4,030,488 of James H. Hasty; providing means for monitoring the pressure in the sleeves, as disclosed in U.S. Pat. No. 4,331,133 of Edward J. Arkans; sensing the pressure in the chambers and then venting to prevent over-pressurizing, as taught in U.S. Pat. No. 4,396,010 of Arkans; and including an arterial thrombosis detection system, as disclosed in U.S. Pat. No. 4,574,812 of Arkans. Other changes and additions will be readily suggested to those skilled in the art in the light of the foregoing description. While the present invention is primarily directed to preventing deep vein thrombosis which can occur while a patient is bedridden, e.g. following surgery, it also may find utility in inhibiting edema, particularly lymphedema, a chronic unilateral or bilateral edema of the legs due to accumulation of interstitial fluid as a result of stasis of lymph, which is secondary to obstruction of lymph vessels or disorders of the lymph nodes. It may also be used for the treatment of chronic venous disease, one consequence of which is venous stasis ulceration of the leg. By way of recapitulation, it will be seen that the present invention provides an improved compression device for the limb in that it permits a more complete venous return or emptying of the leg since it includes compression to the plantar venous plexus. For this reason, trapping of venous blood in the foot veins during compression is obviated. This advantage distinguishes the present invention over the foot pumps of the prior art such as those described in the aforementioned U.S. Pat. Nos. 4,702,232 and 4,841,956 of Gardner and Fox in that the present invention provides a more complete emptying of the limb veins, particularly at the valve cusp, a locus particularly susceptible to stasis. The foregoing detailed description is given for clearness of understanding only and no unnecessary limitations should be understood therefrom, as modifications will be obvious to those skilled in the art.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part application of U.S. patent application Ser. No. 12/893,571, filed on Sep. 29, 2010, the entire disclosure of which is hereby incorporated herein by reference in its entirety. FIELD OF INVENTION [0002] The present invention lies in the field of male contraceptive devices. More specifically, the present disclosure relates to a condom-like sheath that is placed over the male genital member and has a flavor-infusing agent disposed inside the selectively closed, distal end of the condom-like sheath whereby the distal end is operable to release, eject, or secrete the resulting favor-infused fluid during male ejaculation. BACKGROUND OF THE INVENTION [0003] A large variety of condom types are known in the art. In general, condoms are used as one type of contraceptive tool to reduce the possibility of transmitting diseases and unwanted pregnancy between sexual partners. Over time, condoms have evolved in their construction to take into consideration the comfort and sensation that is provided to the user and others who are engaged in the sexual activity. For example, the materials used to construct condoms are generally hypoallergenic and nonabrasive, and oftentimes, are lubricated by some type of fluid composition to prevent the occurrence of an allergic reaction, rash, or other frictional discomfort that is caused by the necessary tight and elastic fit of the condom. In addition, the materials are chosen to reduce the thickness of the condom wall while still maintaining the safety of the device in order to alleviate the symptomatic problem of limited sensation. The condom has also been used as a way to actually enhance or heighten sexual stimulation by incorporating textured elements on the interior and/or exterior surface of the condom that come into intimate contact with the skin, or by applying natural or synthetic compounds to the interior or exterior surface of the condom that have been shown to cause a sexual reaction upon contact with the skin. Thus, the condom has proven to be a useful device in enhancing the pleasure of sex. [0004] While condoms are typically used to reduce the possibility of transmitting a sexually-transmitted disease and the risk of unwanted pregnancy during sexual intercourse, condoms are also used for practicing safe, oral-genital sex, which has gained an increasing popularity in the public eye and has become a more widely publicly-accepted form of sexual activity in comparison to prior history. Although there is no concern of pregnancy, the oral cavity and the surrounding lips and facial skin all provide a substantial opportunity for the transmission of disease through any breaks in the skin/blood barrier or mucosa when in direct, skin-to-skin contact with the genital region of a sexual partner. Accordingly, although somewhat obstructive, a condom, when placed over the male genital area, provides an important barrier between the skin and tissue surfaces of the mouth and the skin surface of the penis when performing oral-genital sex upon a male partner. [0005] However, when involving the oral senses of the body, taste and smell are significant factors in determining whether a person has a pleasurable experience in performing oral-genital sex. Because condoms are typically all made of a natural or synthetic polymer material such as latex, rubber, polyurethane, or polyisoprene, they generally do not have an inviting odor, taste or texture when introduced into the mouth. In an effort to mask any undesirable smells or tastes of the condom or to add a unique element of interest to the sexual activity, efforts have been made to add a variety of flavorful substances to the exterior surface of the condom without harming its structural integrity. For example, ingestible or edible flavored substances have been added to lubricants that are used with condoms. In another example, thin films or coatings, or tubular elements of flavorful components have been added to the exterior surface of the condom that dissolve, react, release or otherwise break free from the condom upon frictional contact or, for example, upon contact with saliva or body heat. [0006] Thus, although some advances using flavored substances have been made to make condoms less offensive in their odor and taste in consideration of oral-genital sexual activity, these flavored substances are only applied, either manually or during manufacture, to the exterior surface of the condom as that is the only surface of the condom that comes into contact with the oral cavity. Historically, condoms are sealed and closed at the distal end to prevent the secretion of any bodily fluids. As such, the flavored additions being made to condoms do not address any adverse or hindering odors or smells of any bodily fluids that may be secreted during oral-genital sex that does not involve the use of a condom or in instances where the condom is removed just prior to climax. For many people, any contact with or ingestion of these bodily fluids creates a significant aversion to engaging in oral-genital sex or performing oral-genital sex for any significant period of time or until the male achieves a climax. Particularly, the odor and smell of seminal fluid is oftentimes considered undesirable by a person who is performing oral-genital sex upon a male partner. Therefore, it would be beneficial to equip the interior of a condom-like device with a flavor-infusing agent that improves the taste and smell of any seminal fluid that is secreted from the penis so as not to hinder the pleasure and completion of the act of oral-genital sex. [0007] In furtherance of the objective set forth above, it would be advantageous that the flavor-infusing agent be disposed within the condom-like in such a manner that the flavor component substantially comingles with, or otherwise alters the flavor profile or characteristic of, the seminal fluid upon ejaculation. [0008] Accordingly, a need exists to overcome the problems discussed above. SUMMARY OF THE INVENTION [0009] With the foregoing and other objects in view, there is provided, in accordance with the invention, a male contraceptive device comprising an elastic condom-like sheath defining an interior and having an open proximal end for receiving a male genital member and a distal end that is selectively closed. The distal end has a distal tip that is in fluid communication with the interior and defines a reservoir having a flavor-infusing agent disposed therein such that, upon pressure from seminal fluid entering the reservoir, the flavor of the seminal fluid is altered by the flavor-infusing agent and the altered seminal fluid is released from the distal end and into the environment outside the sheath. [0010] In accordance with another feature of the invention, the flavor-infusing agent is an ingestible flavored compound that substantially commingles with and alters the flavor of seminal fluid entering the reservoir. [0011] In accordance with a further feature of the invention, the flavor-infusing agent is an ingestible flavored compound that, upon contact with seminal fluid entering the reservoir, alters the flavor of the seminal fluid. [0012] In accordance with an added feature of the invention, the flavor-infusing agent is a porous barrier that permits fluid to flow therethrough and, upon contact with seminal fluid entering the reservoir and flowing therethrough, alters the flavor of the seminal fluid. [0013] In accordance with an additional feature of the invention, the flavor-infusing agent is at least one of a flavored liquid, a dry, flavored powder, and a flavored gas compound. [0014] In accordance with yet another feature of the invention, the flavor-infusing agent is a flavored coating that has been applied along an interior surface of the reservoir and is operable to infuse flavor into a fluid upon contact with that fluid. [0015] In accordance with yet a further feature of the invention, the distal end further comprises at least one perforation that, when broken, permits fluidic communication between the interior and the environment outside the sheath and release of seminal fluid from inside the reservoir into the environment. [0016] In accordance with yet an added feature of the invention, the distal end further comprises at least one removable portion that, when removed from the distal end, creates at least one aperture in the distal end that permits fluid communication between the interior and the environment outside the sheath and release of the fluid from inside the reservoir into the environment. [0017] In accordance with yet an additional feature of the invention, the distal tip further comprises an aperture permitting fluid communication between the interior and the environment outside the sheath. [0018] In accordance with a concomitant feature of the invention, the interior of the sheath further comprises at least one perforation that, when broken, permits fluidic communication between the reservoir and the environment outside the sheath and release of the fluid from inside the reservoir and into the environment. [0019] In accordance with a further feature of the invention, the interior of the sheath further comprises at least one selectively-closed aperture that permits fluidic communication between the reservoir and the environment outside the sheath and release of the fluid from inside the reservoir and into the environment. [0020] In accordance with yet an added feature of the invention, there is provided a patch removably secured to the distal end and sealingly covering the aperture such that, when the patch is removed from the distal end, the distal tip is operable to release the fluid from the reservoir through the aperture into the environment outside the sheath. [0021] In accordance with a further added feature of the invention, there is provided a tab removably secured to the distal end and sealingly covering the aperture such that, when the tab is at least partially removed from the distal end, the distal tip is operable to release the fluid from the reservoir through the aperture into the environment outside the sheath. [0022] In accordance with an additional feature of the invention, the distal end further comprises a one-way valve that, when biased open, creates an aperture in the distal end that permits the release of fluid in a single direction from the reservoir through the aperture into the environment outside the sheath. [0023] In accordance with a further feature of the invention, the one-way valve is operable to bias open in response to force created by seminal fluid entering the reservoir. [0024] With the objects of the invention in view, there is also provided a method for constructing a male contraceptive device, comprising forming an elastic condom-like sheath to define a sheath interior and to have an open proximal end for receiving a male genital member and a selectively closed distal end with a distal tip in fluid communication with the sheath interior and defining a reservoir; disposing a flavor-infusing agent within the reservoir, the flavor-infusing agent being operable to, upon mixture with seminal fluid entering the reservoir, alter the flavor of the seminal fluid; and wherein the selectively closed distal end is operable to release the altered seminal fluid from the distal end into the environment outside the sheath in response to pressure from the seminal fluid entering the reservoir. [0025] Additional advantages and other features characteristic of the present invention will be set forth in the detailed description that follows and may be apparent from the detailed description or may be learned by practice of exemplary embodiments of the invention. Still other advantages of the invention may be realized by any of the instrumentalities, methods, or combinations particularly pointed out in the claims. The construction and method of operation of the invention, however, together with additional objects and advantages thereof, will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings. [0026] Although the invention is illustrated and described herein as embodied in a condom-like sheath that is placed over the male genital member and has a flavorful formulated solution disposed inside the closed, distal tip of the condom-like sheath, it is, nevertheless, not intended to be limited to the details shown because various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. [0027] Other features that are considered as characteristic for the invention are set forth in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0028] Advantages of embodiments of the present invention will be apparent from the following detailed description of the preferred embodiments thereof, which description should be considered in conjunction with the accompanying drawings in which: [0029] FIG. 1 is a perspective view from a side of a condom-like sheath device according to a first exemplary embodiment of the present invention, the dashed lines in the proximal end indicating a stretched contour of the proximal end; [0030] FIG. 2 is a perspective view from a side of a condom-like sheath device according to a second exemplary embodiment of the present invention, the dashed lines in the proximal end indicating a stretched contour of the proximal end; and [0031] FIG. 3 is a perspective view from a side of the condom-like sheath device according to a third exemplary embodiment of the present invention, the dashed lines in the proximal end indicating a stretched contour of the proximal end. DETAILED DESCRIPTION OF THE INVENTION [0032] As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms. Therefore, specific structural and functional 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. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the invention. While the specification concludes with claims defining the features of the invention that are regarded as novel, it is believed that the invention will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward. The figures of the drawings are not drawn to scale. [0033] Before the present invention is disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms “a” or “an,” as used herein, are defined as one or more than one. The term “plurality,” as used herein, is defined as two or more than two. The term “another,” as used herein, is defined as at least a second or more. The terms “including” and/or “having,” as used herein, are defined as comprising (i.e., open language). The term “coupled,” as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically. [0034] Relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” or any other variation thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “comprises . . . a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element. [0035] As used herein, the term “about” or “approximately” applies to all numeric values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of skill in the art would consider equivalent to the recited values (i.e., having the same function or result). In many instances these terms may include numbers that are rounded to the nearest significant figure. In this document, the term “longitudinal” should be understood to mean in a direction corresponding to an elongated direction of the object being described. [0036] The device of the present invention provides a unique way to flavorfully alter the odor and taste of semen or other seminal fluid that is secreted or ejaculated by a male partner while engaging in oral-genital sex. The objective of the present invention is to improve the experience of coming into contact with or ingesting the semen or other seminal fluid by the partner who is performing the oral activity on the male partner and to add an unexpected and interesting element to the sexual act. [0037] Referring now to the figures of the drawings in detail and first, particularly to FIG. 1 , there is shown a first exemplary embodiment of the condom-like sheath device according to the present invention. The device 1 is comprised of a longitudinal tubular member 10 that has a proximal end 20 and a tapered distal end 30 . The longitudinal tubular member 10 is shaped to elastically conform to the elongated shape of a male genital member so as to prevent the inadvertent removal of the device 1 during sexual activity. The proximal end 20 provides an opening 25 that allows the male genital member (not shown) to be inserted into the device 1 such that the device 1 acts as a sheath that tightly covers the male genital member, when erect, in a condom-like fashion. The longitudinal tubular member 10 of the device 1 may be comprised of any suitable material for making condoms, such as natural or synthetically-made latex, as is well-known in the art. The opening 25 is shown in FIG. 1 as being extended or stretched outward from its at-rest state of the device 1 , the dashed lines in the proximal end indicating a stretched contour of the opening 25 . [0038] In the present embodiment, the distal end 30 of the device 1 is provided with and terminates into a distal tip 35 that forms a reservoir 55 . As shown in FIG. 1 , inside the reservoir 55 there is disposed a flavor-infusing agent 60 (indicated with darkened lines). The flavor-infusing agent 60 may be comprised of any non-toxic compound, or a combination of compounds, that is both edible and capable of commingling with, or otherwise altering the flavor profile or characteristic of, seminal fluid that has come into contact with the flavor-infusing agent 60 inside the reservoir 55 . Such agents include, but are not limited to, flavored liquid substances, flavored gaseous compounds, or dry, flavored coatings, powders, or chemical films disposed inside or along the interior surface of the reservoir 55 . Such agents may be in the form of, for example, flavored nectars, syrups, gels, or extracts, flavored, dry powders such as cocoa or mint powders, plain crystalline sugar or sugar infused with other flavors (e.g. vanilla), a flavor-infused vapor, and flavored liquids that have been applied as a film or coating on the interior surface of the reservoir and either remain in liquid form or are allowed to dry (similar to the ingestible breath freshener films currently available on the market that dissolve on contact with the tongue). In another example, a small mesh material or other type of porous or filter-like surface or barrier that imparts a flavor upon any substance that flows through it may be positioned inside the reservoir 55 . The flavor of the flavor-infusing agent 60 may be chosen from an extensive variety of flavors that include, but are not limited to, the flavor of any type of fruit, spice, mint, or candy. The flavor-infusing agent may be disposed within the reservoir 55 during the method of manufacture and assembly of the device 1 , or, alternatively, may be disposed within the reservoir 55 just prior to use of the device 1 . [0039] Unlike existing condom devices, the distal end 30 of the device 1 is atypically made to not be completely or permanently closed. For example, as shown in the exemplary embodiment of FIG. 1 , the distal tip 35 may include a small aperture 50 that allows fluid to leak from the reservoir 55 of the distal tip 35 , as is described in further detail below. In another exemplary embodiment, the distal tip 35 may be formed to have a perforated portion (not shown) that can be torn along the perforations, and in some cases, removed, to selectively create the small aperture 50 . In the first example, whereby the distal tip 35 is initially formed with a small aperture 50 , the small aperture 50 may be selectively sealed by a patch or tab 40 that is removably secured to the distal end 30 or the distal tip 35 such that it may be torn off at a later time when it is desirable to release or dispense the flavored solution 60 from the device 1 . The patch or tab 40 may be removably secured to the distal end 30 or the distal tip 35 by any suitable method that does not damage the exterior surface of the distal end 30 or the distal tip 35 and does not unduly hamper the sexual activity. For example, the patch or tab 40 may be removably secured to the distal end 30 or the distal tip 35 by a non-toxic and, if desired, edible pressure sensitive adhesive or a contact adhesive that is applied to the bonding surfaces of both the distal end 30 or the distal tip 35 and the patch or tab 40 . The above-described embodiments are merely exemplary and it is envisioned that there are a variety of ways, other than a single small aperture at the distal tip, in which the device 1 may be made to not be completely or permanently closed such that the contents of the reservoir may be secreted or exit the device 1 during use. For example, a number of perforated areas and/or selectively sealed apertures may be formed in a number of places along the distal end 30 of the device 1 , or elsewhere along the length of the longitudinal tubular member 10 of the device 1 . It is also envisioned that a system or series of one or more ducts (not shown) that are in fluid communication with the reservoir 55 may be formed in the interior of the device 1 . Upon pressure build-up in the reservoir 55 , the ducts funnel or otherwise direct the contents of the reservoir 55 to another area of the device 1 for secretion. [0040] In operation, the condom-like sheath device 1 is applied to the male genital member in a condom-like fashion prior to engaging in sexual intercourse or oral-genital sex, whereby the fluid-infusing agent 60 has been disposed within the reservoir 55 . Initially, the structural measures for selectively sealing the distal end 30 are kept in place. For example, with respect to the embodiment of FIG. 1 , any perforations at the distal tip 35 are kept intact or, where used, the patch or tab 40 is removably secured to the distal tip 35 . As the sexual activity progresses, the perforations are broken or the patch or tab 40 is torn off or otherwise removed from the distal tip 35 at a desirable point in time, such as the instant before the male reaches climax. Breaking of the perforations or removal of the patch or tab 40 creates or opens the small aperture 50 . By opening the small aperture 50 at that point in time, the ejaculate released by the male during climax substantially comingles or comes into contact with the flavor-infusing agent 60 . Due to the force of the ejaculation, the flavor profile or characteristic of the seminal fluid is influenced by the flavor-infusing agent 60 , and the resulting fluid is dispensed or secreted from the distal tip 35 . As a result, any encounter by others with the seminal fluid is much less offensive in odor and taste due to the flavored additive. [0041] In FIG. 2 , there is shown another exemplary embodiment of the condom-like sheath device 1 . Similar to the exemplary embodiment depicted in FIG. 1 , the device 1 is comprised of a longitudinal tubular member 10 , having a proximal end 20 and a tapered distal end 30 and shaped to elastically conform to the elongated shape of a male genital member. The proximal end 20 provides an opening 25 for insertion of the male genital member such that the device 1 acts as a sheath that tightly covers the male genital member as described above with respect to the embodiment of FIG. 1 . The opening 25 is shown in FIG. 2 as being extended or stretched outward from its at-rest state of the device 1 , the dashed lines in the proximal end indicating a stretched contour of the opening 25 . The distal end 30 of the device 1 terminates into distal tip 35 that forms a reservoir 55 in which there is disposed a flavor-infusing agent 60 . Further, the distal tip 35 includes a small aperture 50 that allows fluid to leak from the reservoir 55 . [0042] However, in this particular embodiment, the small aperture 50 is not defined by one or more breakable perforations or is not temporarily and selectively sealed by a patch or tab that is removably secured to the distal tip 35 . Rather, as is shown in FIG. 2 , the small aperture 50 is selectively sealed by a second outer longitudinal tubular member 140 that is placed over the inner tubular member 10 in overlapping contact and covers at least the distal end 30 of the inner tubular member 10 . The second outer tubular member 140 is shaped to tightly overlap the inner tubular member 10 so as to prevent it from being removed inadvertently. Thus, the second outer tubular member 140 may also be comprised of any material that is suitable for a condom device such that is has the necessary elasticity and, in an exemplary embodiment, the material is the same as the material of the device 1 . To further prevent the inadvertent removal of the second outer tubular member 140 , a non-toxic and, if desired, edible pressure sensitive adhesive or contact adhesive may be applied between the contact surfaces of the inner tubular member 10 and the outer tubular member 140 to temporarily hold the inner tubular member 10 and the outer tubular member 140 together. [0043] In a similar manner to the inner tubular member 10 , the second outer tubular member 140 has an open proximal end 125 that allows it to be slipped over at least the distal end 30 of the inner tubular member 10 . A distal end 145 of the second outer tubular member 140 terminates into a permanently closed distal tip 150 that forms a reservoir 155 . For purposes of the present invention, the term “closed” includes, but is not limited to an impervious barrier. For example, the term “closed” may, in some embodiments, be defined as meaning “water impermeable.” Reservoir 155 is shaped to receive the reservoir 55 of the distal tip 35 of the inner tubular member 10 when the second outer tubular member 140 is slipped over the inner tubular member 10 . Accordingly, the small aperture 50 of the inner tubular member 10 is sealed by the overlapping, closed distal tip 150 of the second outer tubular member 140 . [0044] As described above, at a chosen point in time during sexual intercourse or oral-genital sex, it may be desirable to unseal the small aperture 50 to allow fluids to leak from the distal tip 35 . This is accomplished by pulling off or otherwise removing the second outer tubular member 140 and leaving the inner tubular member 10 completely exposed. By unsealing the small aperture 50 at that point in time, the force of the ejaculate released by the male during climax causes the seminal fluid to substantially comingle or come into contact with the flavor-infusing agent 60 and to be dispensed or secreted from the distal tip 35 with an altered flavor profile or characteristic. As one exemplary embodiment for assisting with removal of the second outer tubular member 140 from the inner tubular member 10 , one or more tabs 160 can be located at the second outer tubular member 140 and the tabs 160 can be attached to the second outer tubular member 140 or integral therewith. [0045] Referring now to FIG. 3 , there is shown another exemplary embodiment of the condom-like sheath device 1 . Similar to the exemplary embodiments depicted in FIGS. 1 and 2 , the device 1 is comprised of a longitudinal tubular member 10 , having a proximal end 20 and a tapered distal end 30 and shaped to elastically conform to the elongated shape of a male genital member. The proximal end 20 provides an opening 25 for insertion of the male genital member such that the device 1 acts as a sheath that tightly covers the male genital member as described above with respect to the embodiments of FIGS. 1 and 2 . The opening 25 is shown in FIG. 3 as being extended or stretched outward from its at-rest state of the device 1 , the dashed lines in the proximal end indicating a stretched contour of the opening 25 . [0046] The distal end 30 of the device 1 terminates into a distal tip 35 that forms a reservoir 55 in which there is disposed a flavor-infusing agent 60 . The distal tip 35 has a small aperture 50 that allows fluid to leak from the reservoir 55 through a one-way valve 240 that is integral with the distal tip 35 and permits fluid to exit, but not enter, the reservoir 55 in only one direction. Examples of a suitable one-way valve include, but are not limited to, a check valve, a flap valve and/or a slit valve. [0047] The one-way valve 240 is operable to open when the amount of pressure or force inside the reservoir 55 reaches a certain point that is sufficient to bias the one-way valve open. In this particular embodiment, the one-way valve 240 is configured to open in response to the natural pressure that is created during male ejaculation. Thus, in operation, the ejaculate released by the male during climax causes the one-way valve 240 to open, thereby causing the semen to combine with or come into contact with the flavor-infusing agent 60 and to exit the device 1 through the aperture 50 at substantially the same time. [0048] To further the intensity of the flavor of the device 1 , flavorful elements may be applied to or integrated into the exterior surface of the device 1 , as is well-known in the art. [0049] In addition, to provide a visual indication of the flavor of the flavor-infusing agent 60 that is disposed inside the reservoir 55 of the distal tip 35 , artistic embellishments may be applied to the exterior surface of the device 1 to enhance or create a theme that is consistent or associated with the particular flavor of the agent 60 . [0050] The foregoing description and accompanying drawings illustrate the principles, preferred embodiments and modes of operation of the invention. However, the invention should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art and the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the invention as defined by the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS Not Applicable FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT Not Applicable REFERENCE TO A MICROFICHE APPENDIX Not Applicable FIELD OF INVENTION The present invention relates generally to a medical insufflating apparatus, and more specifically to a nasal cannula apparatus having one or more adjustable members which allows a wearer to manually position and maintain fluid supply tubing away from substantially contacting the ears of the wearer. BACKGROUND Nasal cannula apparatus provides the wearer with supplemental fluids, typically, but not exclusively, oxygen, to help compensate for reduced pulmonary function arising from such diseases as emphysema, severe bronchitis and other cardiopulmonary maladies caused by disease progression or trauma. In the relevant art, the nasal cannula are typically held in place by having one or more fluid supply tubes rest upon the upper surfaces of the ears and sides of the head adjacent to the ears as a means of support. In many cases, the nasal cannula must be worn for prolonged periods of time which results in significant irritation, ulceration and possible microbial infection of the skin at the points of contact with the ears and sides of the head. Moreover, many of these unfortunate individuals require the supplemental fluids to be provided at all times for their very survival. As such, the wounds induced by the fluid supply tubes have little chance to heal. An example of a very common nasal cannula arrangement is disclosed in U.S. Pat. No. 4,106,505 to Salter, et al., which is hereby incorporated by reference in its entirety. The invention to Salter attempts to solve a significant contact irritation problem which occurs at the nostrils and upper lip of the wearer. While the nostril area is more prone to irritation due to moisture, greater concentrations of invasive bacteria and friction transferred to the cannula by the wearer's head movements, this common arrangement transfers the contact irritation problem from the nostril area to portions of the ears and sides of the wearer's head and is therefore not a complete solution for those individuals requiring constant fluid supplementation or otherwise have skin sensitized to the plastics used to form the fluid supply tubes. Therefore, there is a need for a nasal cannula apparatus which is repositionable by the wearer to a more comfortable position about the head of the wearer. SUMMARY The invention addresses the limitations described above and provides a nasal cannula apparatus which allows the wearer to retentively position the fluid supply tubes away from the ears. In a first aspect of the invention, a nasal cannula apparatus is disclosed comprising at least one fluid supply tube having contiguously coupled thereto; a nasal insufflating member and at least one adjustment member configured to maintain the contiguous flow path between the fluid supply tube and the nasal insufflating member. In this first aspect of the invention, the adjustment member includes memory means for maintaining a position set by the wearer of the nasal cannula apparatus, such that the fluid supply tube may be positioned to avoid substantial contact with an ear of the wearer. In one embodiment of this first aspect of the invention, the adjustment member comprises a bellows joint member having a first nozzle and a second nozzle mounted in opposition along a long axis of the bellows joint member and coaxial with the at least one fluid supply tube first and the second nozzles are dimensioned to sealingly fit within or over a portion of the fluid supply tube. In another embodiment of this first aspect of the invention, the adjustment member is constructed from a polymeric material, a malleable non-magnetic metallic material or a combination of the polymeric and a malleable non-magnetic metallic material. In another embodiment of this first aspect of the invention, the adjustment member is coaxially coupled to the fluid supply tube at a position in proximity to the nasal insufflating member. In yet another embodiment of this first aspect of the invention the adjustment member consists essentially of a generally tubular member having a first nozzle and a second nozzle mounted in opposition along a long axis of the tubular insert and coaxial with the fluid supply tube. In a related embodiment of this first aspect of the invention, the adjustment member comprises a malleable non-ferromagnetic metal joint constructed from one of aluminum, copper or austenitic stainless steel. In a final embodiment of this first aspect of the invention, the adjustment member consists essentially of a malleable non-ferromagnetic metal member embedded longitudinally along at least a portion of the fluid supply tube. In a related embodiment of this first aspect of the invention, the adjustment member comprises a malleable non-ferromagnetic metal joint constructed from one of aluminum, copper or austenitic stainless steel. In a second aspect of the invention, a nasal cannula apparatus is disclosed comprising a first fluid supply tube and a second fluid supply tube, where the first and the second fluid supply tubes are arranged generally in parallel and separable from each other. The first fluid supply tube includes a first end coupled to a first part of a Y-fitting. A second end of the first fluid supply tubing is coupled to a first part of a first adjustment means. A first supply segment tube having a first segment end is coupled to a second part of the first adjustment means and a second segment end is coupled to a first part of a second adjustment means. A second supply segment tube having a first segment end is coupled to a second part of the second adjustment means, and a second segment end is coupled to a first part of a nasal insufflating member. The second fluid supply tube includes a first end coupled to a second part of the Y-fitting; a second end coupled to a first part of a third adjustment means; and, a third supply segment tube having a first segment end coupled to a second part of the third adjustment means; a second segment end coupled to a first part of a fourth adjustment means; and, a fourth supply segment tube having a first segment end coupled to a second part of the third adjustment means; a second segment end coupled to a second part of the nasal insufflating member; a common fluid inlet supply tube coupled to a third part of the Y-fitting such that the first supply tube and the second supply tube form a closed fluid supply loop which discharges into the first and the second parts of the nasal insufflating member; and, a retaining means for maintaining the first fluid supply tube and the second fluid supply tube in proximity to the Y-fitting. In one embodiment of this second aspect of the invention, at least one of the first, second, third and fourth adjustment means includes memory means for maintaining a position set by a wearer of the nasal cannula apparatus, such that at least one of the first or the second fluid supply tubes may be positioned to avoid substantial contact with an ear of a wearer. In another embodiment of this second aspect of the invention, the first and the second adjustment means and at least one of the third and the fourth adjustment means includes memory means for maintaining at least one position set by a wearer of the nasal cannula apparatus, such that both the first and the second fluid supply tubes may be individually positioned to avoid substantial contact with one or more ears of a wearer. In a final embodiment of this second aspect of the invention, the first and the second adjustment means and at least one of the third and the fourth adjustment means includes a bellows joint member, each bellows joint member having a first nozzle and a second nozzle mounted in opposition along a long axis of each of the bellows joint members. In a third aspect of the invention, a nasal cannula apparatus is disclosed comprising a first fluid supply tube and a second fluid supply tube, where the first and the second fluid supply tubes being arranged generally in parallel and separable from one another; the first fluid supply tube having a first end coupled to a first part of a Y-fitting; a second end coupled to a first part of a nasal insufflating member; and the second fluid supply tube having; a first end coupled to a second part of the Y-fitting; a second end coupled to a second part of the nasal insufflating member; and, the adjustment means for maintaining a position set by a wearer of the nasal cannula apparatus, such that at least one of the first or the second fluid supply tubes may be positioned to avoid substantial contact with an ear of a wearer. In one embodiment of this third aspect of the invention, the adjustment means includes one of a non-ferromagnetic metal ribbon and a non-ferromagnetic metal wire embedded in at least a portion of one of the first fluid supply tube or the second fluid supply tube. In a related embodiment of this third aspect of the invention the non-ferromagnetic metal ribbon is embedded along at least a portion of a long axis of at least one of the first fluid supply tube and the second fluid supply tube. In a second embodiment of this third aspect of the invention, the adjustment means comprises a polymeric sleeve coaxially mounted externally along a long axis of at least a portion and at least one of the first fluid supply tube and the second fluid supply tube, where the polymeric sleeve has embedded either a non-ferromagnetic ribbon or a non-ferromagnetic wire. In a first methodic aspect for using the nasal cannula apparatus described above comprises positioning the nasal insufflating member in proximity to at least one nostril of the wearer; and manually adjusting the at least one adjustment member such that the at least one fluid supply tube avoids substantial contact with the ear of the wearer. In a second methodic aspect for using the nasal cannula apparatus described above comprises positioning the nasal insufflating member in proximity to at least one nostril of a wearer; positioning the first fluid supply tube around one side of a head of the wearer; positioning the second fluid supply tube around the other side of the head of the wearer; and, manually adjusting the at least one of the first adjustment means, the second adjustment means, the third adjustment means and the fourth adjustment means such that the at least one of the first fluid supply tube and the second fluid avoids substantial contact with an ear of the wearer. In a third methodic aspect for using the nasal cannula apparatus described above comprises positioning the nasal insufflating member in proximity to at least one nostril of the wearer; positioning the first fluid supply tube around one side of a head of the wearer; positioning the second fluid supply tube around the other side of the head of the wearer; and manually adjusting the at least one of the adjustment means, such that the at least one of the first fluid supply tube and the second fluid avoids substantial contact with the ear of the wearer. BRIEF DESCRIPTION OF DRAWINGS The features and advantages of the invention will become apparent from the following detailed description when considered in conjunction with the accompanying drawings. Where possible, the same reference numerals and characters are used to denote like features, elements, components or portions of the invention. Optional components are generally shown in dashed lines. It is intended that changes and modifications can be made to the described embodiment without departing from the true scope and spirit of the subject invention as defined in the claims. FIG. 1 —is a frontal view of an aspect of the invention in which a wearer has retentively positioned fluid supply tubes away from his or her ears. FIG. 1 a —is a side view of an aspect of the invention in which a wearer has retentively positioned fluid supply tubes away from his or her ears. FIG. 1 b —is a rear view of an aspect of the invention in which a wearer has retentively positioned fluid supply tubes away from his or her ears. FIGS. 2 a - 2 d —depicts an aspect of the invention that incorporates a flexible bellows joint as an adjustment member. A FIG. 3 a - 3 d depicts an aspect of the invention that incorporates a non-ferromagnetic metal tube as an adjustment member. FIGS. 4 a - 4 e depicts an aspect of the invention that incorporates a polymeric joint having a non-ferromagnetic ribbon or wire embedded therein as an adjustment member FIGS. 5 a - 5 b depicts an aspect of the invention that incorporates a polymeric fluid supply tube having a non-ferromagnetic ribbon or wire embedded therein as an adjustment member. DETAILED DESCRIPTION This present invention provides a wearer of nasal cannula apparatus the ability to reposition the fluid supply tubes to be oriented in a more comfortable position by adding lightweight flexible polymeric joints and/or malleable non-ferromagnetic metals to the nasal cannula apparatus as is described in the various aspects and embodiments of the inventions provided below. Referring to FIG. 1 , a first exemplary embodiment of the invention is shown in which a wearer 5 has comfortably positioned a nasal cannula apparatus away from the ears 60 . The nasal cannula apparatus includes a first fluid supply tube 20 which is joined to an inlet side of a first adjustment member 30 a . A first fluid supply tube segment 35 is joined to the outlet side of the first adjustment member 30 a at one end and is joined to an inlet side of a second adjustment member 30 b at the opposite end. A second fluid supply tube segment 50 is joined to the outlet side of the second adjustment member 30 be at one end and to a first inlet side of a nasal insufflating member 55 at its opposite end. Likewise, a second fluid supply tube 15 is joined to an inlet side of a third adjustment member 30 c . A third fluid supply tube segment 40 is joined to the outlet side of the third adjustment member 30 c at one end and to an inlet side of a fourth adjustment member 30 d at the opposite end. A fourth fluid supply tube segment 45 is joined to the outlet side of the fourth adjustment member 30 d at one end and to a second inlet side of the nasal insufflating member 55 at its opposite end. In this embodiment of the invention, the first and second fluid supply tubes 20 , 15 are shown routed over the top the wearer's head 5 and held in position by a retaining clip 25 depicted in FIGS. 1 a , 1 b. The diameters of the first and second fluid supply tubes 20 , 15 and the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 are generally equal and constructed of like polymeric materials to ensure a balanced fluid flow is delivered to the nasal insufflating member 55 . A larger diameter common fluid supply tube 10 delivers the fluid from a reservoir to the first and second fluid supply tubes 20 , 15 by way of a Y-fitting 70 depicted in FIG. 1 b . The first, second, third and fourth adjustment members 30 a , 30 b , 30 c , 30 d are coaxially joined to the first and second fluid supply tubes 20 , 15 and the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 so as to not interfere with the fluid supply being delivered to the wearer 5 . While four adjustment members 30 a , 30 b , 30 c , 30 d are shown in this figure, one skilled in the art will appreciate that fewer adjustment members could be used to allow the wearer to reposition the fluid supply tubes to achieve a more comfortable position. The polymeric construction materials of the first and second fluid supply tubes 20 , 15 , the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 and common fluid supply tube 10 are preferably of a thermo plastic such as polyvinyl chloride (PVC) having a sufficient plasticizer to allow flexibility and suppleness. PVC or other common thermo plastic polymers used in the current art are acceptable for use in the various components incorporated into the invention. Additional construction materials may be incorporated or replace the polymeric construction of the first, second, third and fourth adjustment members 30 a , 30 b , 30 c , 30 d as described below. Referring to FIG. 2 a , a first embodiment of the invention is depicted. In this embodiment of the invention, a flow through adjustable bellows joint (adjustment member) 30 a is disposed into the nasal cannula invention at two or more of the adjustment member positions 30 a , 30 b , 30 c , 30 d depicted in FIG. 1 . The bellows joint(s) 30 a are constructed with inlet 75 and outlet nozzles 80 for attachment to the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . The designation of inlet and outlet are used for convenience only. The adjustment members are intended to be simple flow-through devices which lack flow directivity restrictions. The adjustment members, as is depicted in FIG. 2 b , are constructed of polymeric materials which are compatible with the polymeric construction materials of the first and second fluid supply-tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . To achieve the necessary flexibility, positioning memory and structural integrity, a more rigid construction of polymer is used. For example, PVC having a reduced amount of plasticizer as is common used in the non-analogous art of drinking straws with flexible elbow joints. In one embodiment of the invention, depicted in FIG. 2 c , the adjustment members 30 a are dimensioned to fit into the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . In this embodiment of the invention, the outer diameters of the inlet and outlet nozzles 75 , 80 are slightly larger than the inner diameters of the fluid supply tubing 35 , 20 . The resilient properties of the dimensionally expanded fluid supply tubing 35 , 20 forms sealed joints over the inlet and outlet nozzles 75 , 80 . This tubing coupling arrangement is commonly employed in the non-analogous art of aquarium aeration tubing. Alternately, the inlet and outlet nozzles may be attached to the various fluid supply tubing using an adhesive. The various inner and outer diameters of the first and second fluid supply tubes 20 , 15 , the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 and/or the inlet and outlet nozzles 75 , 80 may be adjusted accordingly to optimize the fluid flow delivered to the nasal insufflating member 55 depicted in FIG. 1 . In another related embodiment of the invention, depicted in FIG. 2 d , the adjustment members 30 a are dimensioned to fit over the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . In this embodiment of the invention, the inner diameters of the inlet and outlet nozzles 75 , 80 are slightly smaller in diameter than the fluid supply tubing 35 , 20 . The resilient properties of the dimensionally compressed fluid supply tubing 35 , 20 forms sealed joints within the inlet and outlet nozzles 75 , 80 . Alternately, the inlet and outlet nozzles 75 , 80 may be attached to the various fluid supply tubing using an adhesive. As before, the various diameters of the first and second fluid supply tubes 20 , 15 , the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 and/or the inlet and outlet nozzles 75 , 80 may be varied accordingly to optimize the fluid flow delivered to the nasal insufflating member 55 depicted in FIG. 1 . Both embodiments of the invention depicted in FIGS. 2 c and 2 d may be used to retrofit an existing nasal cannula available in the current art or provided as a complete nasal cannula assembly. Inclusion of the bellows joints as adjustment members 30 a , 30 b , 30 c , 30 d allows a wearer 5 of the nasal cannula to adjust various portions of the fluid supply tubing to achieve a more comfortable wearing position. Wearing adjustment is made simply by repositioning of the applicable section(s) of the supply tubing and flexing of the bellows joints (adjustment members 30 a , 30 b , 30 c , 30 d ) depicted in FIG. 1 . Referring to FIG. 3 a , another embodiment of the invention is depicted. In this embodiment of the invention, a flow through adjustable joint 30 a is disposed into the nasal cannula invention at two or more of the adjustment member positions 30 a , 30 b , 30 c , 30 d depicted in FIG. 1 . The flow through adjustment member 30 a is uniform in diameter for direct attachment to the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . The adjustment member 30 a , as is depicted in FIG. 3 b , is constructed of one or more non-ferromagnetic metals that are compatible with the polymeric construction materials of the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . For example, non-ferromagnetic metal tubing constructed from aluminum, copper or austenitic stainless steel may be used for the adjustment members 30 a . Non-ferromagnetic metals are important for wearers who may undergo magnetic resonance imaging (MRI) procedures. If MRI procedures are not of concern, iron alloys may be employed as well. To achieve the necessary flexibility, positioning memory and structural integrity, the wall thicknesses of the metal tubing comprising the adjustment member 30 a is optimized to allow the tubing to bend without reaching the ductility limit(s) of the metal. In one embodiment of the invention, depicted in FIG. 3 c , the adjustment member 30 a is dimensioned to fit into the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . In this embodiment of the invention, the outer diameter of the metal adjustment member 30 a is dimensioned slightly larger than the inner diameters of the fluid supply tubing 35 , 20 . The resilient properties of the dimensionally expanded fluid supply tubing 35 , 20 forms sealed joints over the adjustment member 30 a . Alternately, the adjustment member 30 a may be attached to the various fluid supply tubing using an adhesive. The various inner and outer diameters of the first and second fluid supply tubes 20 , 15 , the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 and/or the inlet and outlet nozzles 75 , 80 may be varied accordingly to optimize the fluid flow delivered to the nasal insufflating member 55 depicted in FIG. 1 . In another related embodiment of the invention, depicted in FIG. 3 d , the adjustment member 30 a is dimensioned to fit over the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . In this embodiment of the invention, the inner diameter of the adjustment member 30 a is slightly smaller in diameter than the fluid supply tubing 35 , 20 . The resilient properties of the dimensionally compressed fluid supply tubing 35 , 20 forms sealed joints within the adjustment member 30 a . Alternately, the adjustment member 30 a may be attached to the various fluid supply tubing using an adhesive. As previously described, the various diameters of the first and second fluid supply tubes 20 , 15 , the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 and/or the inlet and outlet nozzles 75 , 80 may be varied accordingly to optimize the fluid flow delivered to the nasal insufflating member 55 depicted in FIG. 1 . Both embodiments of the invention depicted in FIGS. 3 c and 3 d may be used to retrofit an existing nasal cannula available in the current art or provided as a complete nasal cannula assembly. Inclusion of the metal adjustment members 30 a , 30 b , 30 c , 30 d allows a wearer 5 of the nasal cannula to adjust various portions of the fluid supply tubing to achieve a more comfortable wearing position. Wearing adjustment is made simply by bending of the applicable section(s) of the of the adjustment members 30 a , 30 b , 30 c , 30 d depicted in FIG. 1 . Referring to FIG. 4 a , another embodiment of the invention is depicted. In this embodiment of the invention a flow through flexible polymeric joint (adjustment member) 30 a is disposed into the nasal cannula invention at two or more of the adjustment member positions 30 a , 30 b , 30 c , 30 d depicted in FIG. 1 . The polymeric joint 30 a as depicted in FIG. 4 b , is constructed primarily of polymeric materials which is compatible with the polymeric construction materials of the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . In addition, a thin non-ferromagnetic metal ribbon or wire 65 , 65 ′ is incorporated along a long axis of the polymeric joint (adjustment member) 30 a . The addition of the thin non-ferromagnetic metal ribbon or wire 65 , 65 ′ provides the necessary positioning memory not generally available in the inexpensive thermoplastic polymers normally found in nasal cannula constructions. The metal ribbon or wire 65 , 65 ′ may extruded with the thermoplastic tubing at the time of tubing manufacture or added thereafter by heating the ribbon or wire 65 , 65 ′ beyond the melting point of the thermoplastic and embedding the metal into polymeric tubing. In both of the aforementioned manufacturing methods, the metal ribbon or wire 65 , 65 ′ should be embedded entirely in the polymeric construction of the tubing rather than extending into the fluid flow channel. This reduces the chances of oxidation and possible reaction if high concentrations of oxygen are to be used as the fluid provided to the wearer. In one embodiment of the invention, depicted in FIG. 4 c , the adjustment member 30 a is dimensioned to fit into the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . In this embodiment of the invention, the outer diameter of the adjustment member 30 a is dimensioned slightly larger than the inner diameters of the fluid supply tubing 35 , 20 . The resilient properties of the dimensionally expanded fluid supply tubing 35 , 20 forms sealed joints over the adjustment member 30 a . Alternately, the adjustment member 30 a may be attached to the various fluid supply tubing using an adhesive. The various inner and outer diameters of the first and second fluid supply tubes 20 , 15 , the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 and/or the inlet and outlet nozzles 75 , 80 may be varied accordingly to optimize the fluid flow delivered to the nasal insufflating member 55 depicted in FIG. 1 . In another related embodiment of the invention, depicted in FIG. 4 d , the adjustment member 30 a is dimensioned to fit over the first and second fluid supply tubes 20 , 15 , and/or the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 . In this embodiment of the invention, the inner diameter of the adjustment member 30 a is slightly smaller in diameter than the fluid supply tubing 35 , 20 . The resilient properties of the dimensionally compressed fluid supply tubing 35 , 20 forms sealed joints within the adjustment member 30 a . Alternately, the adjustment member 30 a may be attached to the various fluid supply tubing using an adhesive. As previously described, the various diameters of the first and second fluid supply tubes 20 , 15 , the first, second, third, and fourth supply tube segments 35 , 40 , 45 , 50 and/or the inlet and outlet nozzles 75 , 80 may be varied accordingly to optimize the fluid flow delivered to the nasal insufflating member 55 depicted in FIG. 1 . Both embodiments of the invention depicted in FIGS. 4 c and 4 d may be used to retrofit an existing nasal cannula available in the current art or provided as a complete nasal cannula assembly. Inclusion of the adjustment members 30 a , 30 b , 30 c , 30 d allows a wearer 5 of the nasal cannula to adjust various portions of the fluid supply tubing to achieve a more comfortable wearing position. Wearing adjustment is made simply by bending of the applicable section(s) of the of the adjustment members 30 a , 30 b , 30 c , 30 d depicted in FIG. 1 . Referring to FIG. 4 e , another embodiment of the invention is depicted where the adjustment member 30 a is dimensioned to slidably fit over the first and second fluid supply tubes 20 , 15 , becoming a slidable sleeve which may be repositioned anywhere along the contiguous outer surfaces of the first and second fluid supply tubes 20 , 15 . As such, the adjustment member 30 a in this embodiment of the invention does not become part of the fluid flow channel and is therefore ideal as a simple retrofit of existing nasal cannula apparatus. Usage of this embodiment of the invention by the wearer 5 of the nasal cannula apparatus is nearly identical to that described above with the added advantage of the wearer being able to slide one or more of the adjustment members 30 a , 30 b , 30 c , 30 d to the most comfortable positions along the long axis of the first and second fluid supply tubes 20 , 15 . Referring to FIG. 5 a , a final embodiment of the invention is shown where a non-ferromagnetic metal ribbon or wire 65 is embedded directly in the first and second fluid supply tubes 20 , 15 . This embodiment of the invention is simply an extension of the embodiments of the invention described above for FIGS. 4 a , 4 b , 4 c , 4 d and 4 e where a metal ribbon or wire 65 ′ is incorporated directly into the polymeric construction of the first or second fluid supply tubes 20 , 15 as shown in FIG. 5 b . This embodiment of the invention provides an additional advantage in that there are no rough surfaces or tubing diameter changes involved in the construction of the nasal cannula apparatus. The wearer 5 of the nasal cannula apparatus which incorporates this embodiment of the invention may simply bend the portion or portions of the first and second fluid supply tubes 20 , 15 to the most desirable position without encountering rough edges which could irritate the skin or tubing diameter changes which snag on clothing. All other aspects of this embodiment of the invention are nearly identical to those described above FIGS. 4 a , 4 b , 4 c , 4 d and 4 e. The foregoing described embodiments of the invention are provided as illustrations and descriptions. They are not intended to limit the invention to precise form described. In particular, it is contemplated that functional implementation of the invention described herein may be constructed in various shapes and of different materials. No specific limitation is intended to a particular shape or construction material. Other variations and embodiments are possible in light of above teachings, and it is not intended that this Detailed Description limit the scope of invention, but rather by the Claims following herein.

1a

This application is a divisional of Ser. No. 09/231,790, filed Jan. 15, 1999. This application claims the benefit of provisional application No. 60/071,396, filed Jan. 15, 1998. TECHNICAL FIELD OF THE INVENTION This invention relates to electromechanical devices and methods for therapeutically treating human body tissue, and more particularly to a device for and a method of stimulating cell proliferation and related molecular events using high frequency pulsed electromagnetic energy. BACKGROUND OF THE INVENTION The present invention is an important advancement in the fields of endogenous pharmacotherapeutics, electromagnetic medicine, wound physiology and treatment, and regulation of the cell cycle, and has specific application in the area of wound healing, and in particular, the healing of chronic wounds, such as pressure ulcers, diabetic ulcers and venous stasis ulcers. Prior to discussing the present invention in detail, it is helpful to understand the specific mechanisms of wound healing, the immediate need for wound healing therapies, and the current state of the art. While the specific mechanisms of action have not been fully determined, research over the past several years has substantially increased understanding of the nature of wound healing and the elegant cascade of signaling events necessary for the initiation of cell growth and migration and tissue regeneration, which collectively constitute the wound healing process. Importantly, numerous biochemical mediators of cell migration patterns and cell-cell/cell-extracellular matrix interactions involved in the reformation of tissue/organ systems have been identified. There are distinct phases associated with the process of wound healing. In the inflammatory phase, platelets aggregate to deposit granules, which promote fibrin deposition, and stimulate the release of growth factors. Leukocytes migrate to the wound site and begin to digest and transport debris away from the wound. It is also during the inflammatory phase that monocytes are converted to macrophages, which release growth factors for stimulating angiogenesis and the production of fibroblasts. Next, in the proliferative phase, granulation tissue forms and epithelialization begins. Fibroblasts, key cell types in this phase, proliferate and synthesize collagen to fill the wound and provide a strong matrix on which epithelial cells grow. As collagen is produced by fibroblasts, vascularization extends from nearby vessels to supply nutrients to the regenerating tissue. The red loops of blood vessels give the wound a granular appearance, thus the term granulating. Epithelialization involves the migration of epithelial cells from the wound surfaces to seal the wound. Epithelial cells are driven by the need to contact cells of like type and are guided by a network of fibrin strands which function as a grid over which these cells migrate. Contractile cells called myofibroblasts appear in wounds and aid in wound closure. These cells exhibit collagen synthesis and contractility, and are common in granulating wounds. In the final phase of wound healing, the differentiation or tissue remodeling phase, collagen in the scar undergoes repeated degradation and resynthesis. It is during this phase that the tensile strength of the newly formed skin increases. Clearly, growth factors are important messengers in coordinating this complex orchestration of cellular events. Today, growth factors refer to an expanding class of molecules, sometimes with specificity for certain types of cells, that can have either pro-proliferative or anti-proliferative/differentiation effects, depending upon the specific circumstances. Their immediate molecular targets are specific members in the superfamily of receptor tyrosine kinases. Relatively little is known about the regulation of growth factor activity, but spatial and temporal gradients of growth factor and receptor expression are evident, and expression of a given growth factor or its receptors can be induced by other growth factors, suggesting that sequences of growth factor-mediated messages networked across cell types and integrated with other signaling cascades are central to tissue/organ development, maintenance and healing processes. Thus, the recent realization that growth factors can serve as paracrine, autocrine, juxtacrine and intracrine (which refers to actions of growth factors within a cell) signals to regulate proliferation, migration, and interaction of cells critical to wound healing is important to understanding and developing wound treatments. For example, central to tissue/organ repair and remodeling is the critical revascularization of damaged tissue. Vascular endothelial growth factor (VEGF) is a recently discovered agent that promotes proliferation and migration of endothelial cells. Stimulating the expression of VEGF receptors in endothelial cell precursors allows those cells to respond to VEGF secreted from other cells or to VEGF acting via autocrine/intracrine mechanisms. Stimulating the release of VEGF from fibroblasts and/or other cell types (or stimulating VEGF production in endothelial cells) promotes mitotic and/or migratory activity of endothelial cells. Also critical to tissue repair is establishment of the extracellular scaffold to support cell migration and/or proliferation. Stimulating the release of agents such as fibroblast growth factors (FGF) from any of a number of cell types promotes proliferation and migration of fibroblasts, which are involved in production of extracellular matrix materials such as collagen. Moreover, stimulating FGF receptor production in fibroblasts capable of recognizing paracrine, autocrine, or intracrine FGF also plays a role in stimulating fibroblast activity and the production of extracellular matrix. Other agents implicated in tissue repair include insulin-like, platelet, transforming, and epidermal growth factors. Those molecules and their receptors are the likely molecular substrates for tissue repair. Endothelial cells, fibroblasts and keratinocytes, among others, are the cell types whose activity is critical to tissue repair and represent the likely cellular targets for these growth factors and related molecules associated with the healing of pressure sores. It is also well known that regulatory signals normally found in the repair of acute wounds are not present in chronic wounds such as pressure ulcers and venous stasis ulcers. For example, chronic wounds frequently have poorly vascularized, thick fibrotic scar tissue surrounding the wound bed, are characterized by keratinocytes incapable of proliferation and migration, and have few active fibroblasts. These occurrences are clearly indicative of defects in growth factor signaling. With the understanding that defects in growth factor signaling contribute to the development and/or persistence of chronic wounds, it is logical to conclude that reinstitution or normalization of that signaling would promote wound healing. Growth factors have been considered candidate therapeutics for wound healing because they are synthesized by and stimulate cells required for tissue repair, they are deficient in chronic wounds, and there is some evidence that pharmacological application enhances wound repair in a variety of animal models of dermal incisional and excisional repair. However, clinical studies have been disappointing and some experts have suggested that an alternative to single growth factors as therapeutic agents is the utilization of growth factors in combination to elicit synergistic clinical efficacy. This lack of therapeutic efficacy may be in part because wound healing is a complex programmed sequence of cellular and molecular events, including macrophage activation during inflammation, cell migration, angiogenesis, provisional matrix synthesis, synthesis of collagen by fibroblasts, and reepithelialization. Current pharmaceutical approaches do not fully mimic the necessary spatial and temporal patterns of growth factor activity needed to promote wound healing. Overall, the complexity and variability of clinical wounds have limited pharmacological approaches to accelerate wound healing, leaving dressings and nonpharmacological ancillary modalities to dominate the market associated with wound management. A treatment regimen involving application of outside or exogenous growth factors and other medicinal agents to the wound site is but one approach that has been pursued in the treatment of wound healing. Various medical treatment devices utilizing physical energy emissions to stimulate wound healing have also been developed over the past 40-50 years. Most of these devices involve the use of applied electrical currents to stimulate growth in bone or soft tissue. Another major group of devices utilizes the passage of electrical currents through coils of wire to create magnetic fields which are applied either by placing the coil in proximity to the human body or by wrapping the coils around the body or limb. Finally, a number of devices have been developed which utilize an antenna or tank circuit to apply Radio Frequency (RF) electromagnetic energy to the body for the purposes of medical treatment. Most devices in this latter category utilize continuous energy output to create thermal energy within the tissue. However, a subcategory of these devices utilize pulsed electromagnetic energy output to theoretically stimulate tissue without inducing a thermal response, although this has never been completely proven to occur using existing devices. There have been observations that some of these devices appear to stimulate or accelerate the wound healing process but there has been no sound, scientific data offered to explain how such devices might work at the cellular or molecular levels. One area in which health care professionals and insurance providers are demanding improved treatment regimes is in the treatment of chronic wounds. In the United States, where wound care constitutes less than 1% of aggregate health care dollars, treating and managing pressure ulcers requires an inordinate amount of material, human resources, time and money. The costs associated with managing just one type of chronic wound alone, pressure ulcers, are extraordinary. To enhance quality and decrease the cost of health care, the Agency for Health Care Policy and Research (AHCPR) was established by the U.S. government in 1989. That agency published Clinical Practice Guidelines for both prevention and treatment of pressure ulcers in 1992 and 1994, respectively. The release of these guidelines substantially increased biomedical awareness of patients with pressure ulcers, including the elderly and those afflicted with various spinal and neurological disorders. Importantly, the Health Care Financing Administration (HCFA) utilizes these guidelines to create medical policy and reimbursement criteria. Electrotherapeutic modalities are the only type of adjunctive therapy recommended in the AHCPR Clinical Practice Guideline and supported by the Nation Pressure Ulcer Advisory Panel. Electrotherapy includes various means for applying an electric or electromagnetic field to a wound area to facilitate growth and proliferation of new tissue, i.e., healing. Application of external electrical and electromagnetic fields is now an increasingly standard therapy for the treatment of nonunion bone fractures, but these devices have seen limited use in other areas of healing. Clinical research has shown that treatment with electrical stimulation or electromagnetic fields can enhance the healing rate of pressure ulcers unresponsive to conventional therapy. For example, pulsed electrical stimulation has been shown to enhance the healing rate of decubitus ulcers. This therapeutic approach stems from observations for nearly 60 years that electric potentials over wounds are negative until healed, and the related hypothesis that living tissues possess direct current surface potentials that regulate the proliferative phase of healing and that healing can be induced by negative electrical potential. Unfortunately, this has led to unsubstantiated claims that electrical stimulation cures a wide variety of health problems, thereby alienating the medical profession. Though this idea is now archaic and simplistic in view of scientific studies of the cellular correlates of wound healing, the evidence suggests that electrical fields accelerate wound healing. While few well designed experiments concerning cellular mechanisms have been conducted, some published reports indicate that electrical stimulation activates macrophages and increases cell proliferation, collagen synthesis and the expression of fibroblast receptors for transforming growth factor-beta. Treatment devices emitting magnetic and/or electromagnetic energy offer significant advantages over other types of electrical stimulators because magnetic and electromagnetic energy can be applied externally through clothing and wound dressings, thereby rendering such treatments completely non-invasive. Moreover, published reports of double blind placebo-controlled clinical trials utilizing a RF transmission device (Diapulse) suggest that this ancillary treatment device significantly reduces wound healing time for chronic pressure ulcers as well as for surgical wounds. Studies using Dermagen, a magnetic device manufactured in Europe which produces a low frequency magnetic field, have demonstrated significant augmentation of healing of venous stasis ulcers. Additionally, it has been shown that 50% fewer patients treated with electromagnetic energy develop reoccurring pressure ulcers, compared to control patients, suggesting that electromagnetic energy treatments impart some resistance to the reoccurrence of chronic wounds, such as pressure ulcers. Electromagnetic energy may also be useful as a preventative strategy. Perhaps most important from a practical clinical perspective, an actuarial analysis of the effects of electromagnetic energy on the treatment of pressure ulcers show that this treatment, by reducing healing time by an average of 50%, results in significant reductions in the costs associated with wound management. One category of prior art magnetic/electromagnetic treatment devices utilizes the passage of electrical currents through coils of wire to create magnetic fields. The frequency of the electrical impulses is relatively low, typically in the low frequency or audio range. Other devices, which utilize electrical stimulation between electrodes, represent a substantially different approach to medical treatment from the present invention for the primary reason that such an approach is invasive and more difficult to use and involves the attachment of electrodes at or near the wound site. Another category of prior art electromagnetic treatment apparatus includes high frequency, high power devices utilizing pulsed electromagnetic energy output to stimulate tissue without inducing a thermal response. This category of devices is represented by the inventions disclosed in the following U.S. patents: Milinowski, U.S. Pat. Nos. 3,043,310 and 3,181,535; Kendall U.S. Pat. No. 3,543,762; Pearo U.S. Pat. No. 3,670,737; and most recently Rauch et. al., U.S. Pat. No. 5,584,863. Those earlier inventions first described and defined the principle and operation of pulsed, high frequency energy output devices and/or systems. While numerous high frequency devices using pulsed electromagnetic energy to stimulate tissue growth have been developed, none have effectively addressed the needs of patients and health care providers. A recent attempt, as described in U.S. Pat. No. 5,584,863, is a pulsed radio frequency electrotherapeutic system having a pulse generator and an athermapeutic applicator head. The generator includes a power supply electrically connected to a remote current source by a cord, an exciter for generating pulsed signals of a selectable megahertz frequency, and an amplifier for amplifying the pulsed signals. A system controller having manually operable dials is provided for controlling pulse width duration, pulse burst repetition rate and power amplitude of the pulsed signals generated by the exciter. The amplitude of the signals outputted from the amplifier are compared with a reference value using a standing wave ratio (SWR) detector circuit, which in turn outputs power and impedance compensated signals to the applicator and produces a ratio signal that is delivered to the controller for adjusting the amplitude and phase of the signals generated by the exciter. The applicator, which includes a pair of spaced capacitor plates, a magnetic coil wound in a plane parallel to and electrically connected to the plates, and an RF shield, induces the received compensated signals into the tissue to be treated. Reactance and power level of the output of the applicator are manually controlled using an external tuning means connected to one of the capacitors. The device disclosed in U.S. Pat. No. 5,584,863 has high power requirements, requires numerous manual adjustments for effective operation, incorporates only a single applicator, fails to ensure constant, known and replicable treatment dosage outputs, and provides no confirmation that the applicator is properly located during treatment. While the various and several prior art inventions, as described in the above referenced patents, produce electrical, magnetic or electromagnetic fields for treatment of tissue, virtually none of the prior art describes any credible cellular or physiological or molecular processes by which such energy fields specifically alter, induce or otherwise make happen an increase in cell growth, proliferation or density. Additionally, none of the previous high frequency, high power devices utilizing pulsed electromagnetic energy output adequately addresses such practical design concerns as ease of use, simultaneous treatment of multiple wound sites on the same patient, dosage measurement, monitored dosage control and/or dosage compliance. It would be desirable therefore to provide a method of and an apparatus for treating wounds with high frequency pulsed electromagnetic energy that is easy to implement, requiring minimal training in its proper and effective use, assures a constant, known and replicable dosage output, provides for simultaneous treatment of multiple wound sites, has low power requirements and is cost effective. Citation of the above documents, devices and studies is not intended as an admission that any of the foregoing is pertinent prior art. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicants and does not constitute any admission as to the correctness of the dates or contents of these documents. Further, all documents referred to throughout this application are incorporated in their entirety by reference herein. SUMMARY OF THE INVENTION In view of the foregoing limitations and shortcomings of the prior art, as well as other disadvantages not specifically mentioned above, it should be apparent that there still exists a need in the art for improved electromagnetic energy treatment apparatus and methods. It is therefore a primary object of the present invention to fulfill that need by providing a method of and apparatus for the treatment of chronic wounds using pulsed electromagnetic energy that is cost effective, easy to implement, and ensures proper treatment dosage delivery without the need for manual adjustment of power, pulse rate duration, pulse width duration, treatment time or reactance by the treatment provider. More particularly, it is an object of this invention to provide an electromagnetic energy treatment apparatus with the ability to produce a constant, known and replicable treatment dosage output that is not adversely affected (i.e., does not negate consistent dosage or efficacy) by the proximity of the body of the patient (e.g., capacitance, inductance). It is yet another object of this invention to provide an electromagnetic energy treatment apparatus wherein one or more wound sites may be simultaneously treated with different treatment dosages. It is still another object of this invention to provide an electromagnetic energy treatment apparatus wherein the applicator is easily and accurately positioned directly on or adjacent to the wound site regardless of where the site is located on the patient. Still another object of this invention is to provide an electromagnetic energy treatment apparatus wherein the applicator includes printed coils formed on one or more printed circuit boards, with the primary coil and secondary coil forming a matching network for effecting a highly efficient RF output. In other words, the applicator includes closely matched and tuned primary/secondary circuits, which greatly enhances efficiency by allowing the use of reduced power levels. It is a yet further object of this invention to provide an electromagnetic energy treatment apparatus having the ability to affect living tissue by providing an accurate treatment dosage of 1 to 300 mw/cm 2 with very low input power requirements (i.e., an average power requirement in the range of less than three watts, and preferably less than about one watt). It is a still further object of this invention to provide an electromagnetic energy treatment apparatus wherein treatment dosages are automatically monitored for safety by multiple sensing or detecting circuits and controlled by a field strength sensor. It is a yet further object of this invention to provide an electromagnetic energy treatment apparatus that is small, portable, easy to use and safe to operate, with the apparatus automatically maintaining the appropriate treatment dosage and shutting down when certain conditions are present. Briefly described, the present invention is an improved method of and apparatus for generating and administering treatment dosages of pulsed electromagnetic energy for wound healing applications. Specifically, the present invention generates and applies constant, known and replicable treatment dosages of electromagnetic energy of defined specifications to the human body for the purposes of inducing cell proliferation. In its preferred form, the present invention includes a pulsed electromagnetic energy generator, control means, including a power level controller responsive to signals from multiple sensing and control circuits, and one or more interchangeable treatment pad applicators. The generator, which can be battery-operated, is a low power, compact unit whose output is controlled by the multiple sensing and control circuits via the power level controller. The control circuits include integral sensing circuits for ensuring specified treatment dosage and the safety and effectiveness of the apparatus as a medical instrument, and one or more detectors located in or on each applicator for sensing energy output at the site of application and monitoring, with precision, the treatment dosage. Other circuits are included for disabling the apparatus when certain conditions, such as insufficient power, exist. The generator of the present invention has multiple treatment ports to which one or more applicators are attached via cables to provide for the simultaneous treatment of one or more wound sites on the same patient. Preferably, the apparatus allows the applicators to operate independently and simultaneously at different treatment dosage levels. The applicators are treatment pads of various sizes comprising tuned tank circuits and a field strength sensor to allow for automatic control of the output specifications of the apparatus. Each applicator also has detectors for sensing proximity to the patient during the course of treatment and informing the patient if the applicator inadvertently moves from its intended treatment position. The present invention has numerous advantages not found in existing electromagnetic energy treatment apparatus. First, the generator of the present invention is operationally efficient and has low power requirements, on the range of less than three watts of average power (preferably less than one watt). This allows the unit to be battery operated and greatly reduced in size, thereby rendering the apparatus portable and easy to use, as the small size facilitates transport and placement of the unit, with minimal disruption, in the patient's treatment area during use. Another advantage of the present invention relates to its integration of multiple sensor and control circuits which, for the first time, ensures precise treatment dosage and provides confirmation that the applicator remains on the wound site during the entire course of treatment. In addition, these sensor and control circuits allow for unattended operation of the device during treatment, providing for a highly simplified means of treatment. The multiple monitoring and control circuits are separate and distinct, and include a fixed period treatment timer, forward and reflected power monitor circuits (one for each treatment port provided by the generator), an electromagnetic energy signal strength detector and controller circuit, and a treatment pad to patient proximity detector. Together, those control means guarantee that the correct treatment dosage reaches the patient. Another advantage of the present invention not found in existing electromagnetic treatment devices is the multiple port generator for allowing the simultaneous use of multiple applicators. When using existing electromagnetic treatment devices, caregivers are limited to the treatment of just one wound site per each time interval of unit use. Because many pressure sore patients have two or more wounds, the present invention greatly reduces treatment time and expense since multiple wounds can be treated at once. Preferably, each treatment applicator is selected to operate simultaneously at a different treatment dosage level to accommodate multiple wound sites. Each treatment applicator of the present invention also includes novel elements which overcome several major deficiencies in previous designs. Existing applicators are typically large volume, rigid extensions of the power sources. The applicator of the present invention is substantially reduced in size, bulk and power requirements. This is possible, in part, due to the utilization of low power and the increased operational efficiency of the generator and applicator itself. Preferably, each applicator is thin, flexible and constructed in any of a wide variety of shapes and sizes to accommodate various wound sites. In one embodiment, the treatment pad is configured as a rectangle with dimensions of approximately 10 inches by 5 inches and a nominal thickness of less than ½ inch. Each applicator is a flexible pad comprising one or more etched copper printed circuits laminated between insulating sheets of flexible material having high dielectric properties. The two circuits operate as an impedance matching transformer. Sensing units, including an electromagnetic signal strength detector and an applicator-to-patient proximity detector, are incorporated in each applicator and are in communication with the power level controller to provide for direct monitoring of the electromagnetic energy field and precise control of the treatment dosage. By modifying the topology of the etched printed circuit inductor portion of the LC circuit and then correspondingly adjusting the capacitance value of the capacitor to retune the LC circuit to resonance, the applicator can be constructed in a variety of shapes and sizes to best match the wound size and area on the patient. Moreover, the tank circuit in the applicator is pre-tuned, thereby eliminating the need to manually tune the circuit as it comes into close proximity with the human body or other objects. Given its nominal thickness and increased flexibility, the applicator can be placed over, under or around a bandaged wound site. Other novel and unique features of the applicator include the following. Existing electromagnetic energy devices do not include mechanisms for delivering precise and replicable treatment dosages to the patient. Although previous designs may have specified that the applicator be tuned to resonance or may have included a mechanism for matching the generator and the applicator in order to minimize SWR, there has been no way to ensure that accurate treatment dosage was being delivered through the coils located in the applicator and beyond, to the surface of the patient's wound site. In the present invention, a signal detector, such as a germanium diode signal detector, is included as part of the applicator for measuring the energy emission from the applicator and supplying a feedback signal to the RF amplifier for controlling energy output. The actual electromagnetic energy field, or treatment dosage, that is transmitted from each applicator is measured directly by embedding the RF signal strength detector inside of the applicator. The signal level from the detector is sent to the power level controller, where it is used as a feedback-control signal to control the output of the RF amplifier of the generator. This direct approach to measuring the actual radiated electromagnetic energy field is a much more precise way to measure the treatment dosage, rather than by indirectly measuring the SWR of the transmitted RF signal. If, at any time, the detector measures a radiated energy output level above or below preset levels, an indicator, such as a “service required” lamp or alarm, audibly, visually or otherwise informs the health care provider and patient of the occurrence and the power level controller switches off the RF amplifier. The forward and reflected power measuring circuits are used to turn the unit off only if either circuit exceeds preset limits. In this manner, the present invention monitors energy emissions from each applicator and ensures that the treatment dosage delivered through each applicator is precise. The applicator of the present invention is thin and need not be suspended on a mechanical arm, as required by some existing applicators. Because of the unique configuration of the present invention, a correct treatment dosage is easily and effectively delivered to the patient. The present invention further includes a method of effectively treating chronic wounds such as pressure ulcers involving the precise induction of specific biochemical events associated with cell proliferation. In accordance with the present invention, an electromagnetic field of specified strength and duration is used to stimulate cellular growth and proliferation, membrane ionic flux, growth factor expression, release and functional enhancement, and reductions in cell doubling time. Electromagnetic energy fields are utilized to stimulate and accelerate cell growth and proliferation upon certain types of cells known to be critical to the wound healing process, including fibroblasts and epithelial cells. Electromagnetic stimuli induce cell proliferation by reducing the G 0 and/or G 1 phases of the cell cycle, by stimulating the genetic expression, release and functional enhancement of growth factors, and by inducing the flux of ions across cellular membranes. Therefore, the present invention acts as a mitogen and/or a positive modifier of cellular mitogenic activity. This mitogenic effect results in growth factor stimulation, expression and release, both intra-and extracellularly. A key component of the present method is the specific enhanced actions of fibroblast growth factors. It is important to note that the present method, which utilizes electromagnetic energy as a stimulus for inducing cell proliferation through mechanisms regulating decreases in cell cycle time, is independent of the particular source of the energy emission or the design of the energy source. The term electromagnetic energy includes effects from its magnetic energy and/or electrical energy components. The present method utilizes electromagnetic energy as a mitogenic stimulus to reduce cell cycle time through the expression, synthesis and enhanced activity of growth factors, thereby increasing the overall rate of growth and proliferation in various biological cell types, including those found in ephithelial, muscle, connective and neuronal tissues. Energy waves which are primarily defined as Radio Wave frequencies are used to induce biological cell proliferation in vitro under laboratory conditions and in vivo under clinical conditions in intact living organisms. In the electromagnetic spectrum, those frequencies range from 1000 Hertz to 1000 Megahertz, and therefore also include a portion of the audio frequencies (at the lower end) and range through ultra high frequencies (UHF). The present method delivers an electromagnetic treatment energy of 1 to 300 milliwatts per cm 2 to living tissues (in vivo or in vitro). Because it is a specific cellular mitogen, the present method reduces cell cycle time through the induction of specific cellular mechanisms which reduce the duration of the separate and/or combined G 0 and G 1 phases of the cell cycle. Specific mitogenic physical energy signals are provided that induce cell growth and proliferation in part through the induction of ion flux across cellular membranes and subsequent cellular signaling events, including the expression, synthesis and enhanced activity growth factors, especially fibroblast growth factors. An electromagnetic energy stimulus is utilized to activate intracellular and intercellular mechanisms associated with the genetic expression, synthesis and release of biological molecules necessary to regulate cell cycle time. Because the present method is based upon discoveries pertaining to the effects of specific doses of electromagnetic energy on in vivo and in vitro cells and tissues, the present method offers the significant advantage of fixed power output, pulse rate and pulse width to specifically increase cell growth and proliferation in distinct cell types found in soft tissue, connective tissue, and neuronal cells. Treatments applied using the present method are characterized by specific optimal dosages of pulsed electromagnetic energy to induce cell proliferation of specific cell types. The present method allows utilization of a fixed pulse rate, a fixed pulse width and a fixed energy field strength to define and produce the optimal energy specifications to be used to stimulate specific cell types related to specific medical indications or specific treatment regimens. It also provides for the creation and application of specific dosages and treatment regimens which are required for specific medical indications. Further, the present method can also be implemented to treat wounds other than ulcers, including burns, physical rehabilitation, and neuronal injury. The present invention has immediate commercial market potential in the treatment of chronic wounds. Beyond that immediate market, the present invention may also be utilized in other treatment areas where increasing the rate of growth and proliferation of human or other living cells is essential, including the treatment of burns and surgically implanted skin or soft tissue grafts, rehabilitation medicine, post surgical repair, and neuronal/brain/spinal injury repair and regeneration. In addition to the medical treatment of soft tissue, the present method has applications in the field of laboratory growth/manufacturing of skin grafts to be sold and used in various surgical settings, veterinary medicine and related fields. These and further and other objects and features of the invention are apparent in the disclosure, which includes the above and ongoing written specification, with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram of the generating unit and applicator components of the treatment apparatus of present invention; FIG. 2 a detailed block diagram of the apparatus of FIG. 1; FIG. 3 is a block diagram of the pulse rate generator and treatment energy pulse controller located in the generating unit of FIG. 1; FIG. 4 is a block diagram of the treatment timer located in the generating of FIG. 1; FIG. 5 is a block diagram of the power level controller located in the generating unit of FIG. 1; FIGS. 6A-C is a schematic of one embodiment of the circuit for controlling the output of the pulse generator; FIG, 7 is a block diagram of one embodiment of the generating unit of FIG. 1 having circuits for separately controlling multiple applicators; FIG. 8 is a block diagram of the isolated power supply assembly for the treatment apparatus of FIG. 1; FIG. 9 is a plan view of one embodiment of the applicator of the apparatus of FIG. 1; FIG. 10 is a front view of the applicator of FIG. 9; FIG. 11 is a cross-sectional detail A of the applicator of FIG. 10; FIG. 12 is a plan view of another embodiment of the applicator of the apparatus of FIG. 1; and FIG. 13 is a bottom view of the applicator of FIG. 12 . DETAILED DESCRIPTION OF THE INVENTION Referring now to the drawings, where like elements are designated by like reference numerals throughout, FIG. 1 shows an apparatus 10 , more fully described below, for treating wounds with electromagnetic energy. Apparatus 10 includes an electromagnetic energy generating unit 12 with multiple ports 13 , and multiple applicators 14 connected to unit 12 by coaxial cables 16 . A power source 18 , such as a battery pack, is provided for delivering a current input to unit 12 . While shown in FIG. 1 as a remote unit, battery pack 18 can be incorporated as part of unit 12 . Since the present invention has low power requirements, the power source can be one capable of providing an average power input of less than three watts. Referring to the block diagram of FIG. 2, unit 12 includes a generator 30 for producing a pulsed high frequency signal output 32 and at least one applicator 14 having output 32 as its input. Generator 30 includes a pulse generator 34 and one or more amplifiers 36 having as their inputs a pulsed signal output 38 from the pulse generator 34 . The number of amplifiers 14 is preferably equal to the number of treatment ports, such that each applicator 14 has an input from a single amplifier 36 . Treatment energy pulse controller 40 is connected to pulse generator 34 for automatically controlling characteristics of output 38 such as pulse rate and pulse width. Output 38 is delivered to amplifiers 36 , each of which is individually responsive to signals 42 , 42 i, 42 ii generated by power level controller 44 . Control signals 42 , 42 i, 42 ii from the power level controller 44 reflect feedback information 54 from the field strength detector positioned on each applicator 14 . One or more control circuits, including the forward and reflected power measuring circuits 46 , the treatment timer 48 and the treatment energy pulse controller 40 , detect abnormal conditions and disable operation when appropriate. The power level controller 44 is also responsive to control signals 50 generated by control circuitry in the power supply assembly 52 and control signals 56 received from one or more proximity detectors located on the applicators 14 . Treatment timer 48 , which delivers activation signals 58 , 60 to the power level controller 44 and the treatment energy pulse controller 40 , respectively, for instituting the treatment process over a predetermined period of time, is also responsive to shut down signals 62 from the power level controller 44 for disabling the apparatus 10 when certain conditions are detected. The embodiment of the unit shown in FIGS. 1 and 2 has three treatment ports 13 for simultaneously and independently delivering different output signals 32 to three separate applicators 14 . It should be understood that the number of ports 13 , amplifiers 36 and measuring circuits 46 may be varied without departing from the scope of the present invention. The apparatus shown in FIG. 2 operates as follows. Signals 58 , 60 from treatment timer 48 enable the power level controller 44 and the treatment energy pulse controller 40 , respectively, thereby enabling the pulse generator 34 to produce pulsed signal output 38 . Controller 44 automatically controls specific characteristics of the pulsed signal output 38 produced by generator 38 and received by amplifiers 36 , including pulse rate, pulse width and pulse power level. The pulsed signal output 38 is thus amplified in accordance with instructions received from the power level controller 44 , and specific outputs 32 are produced. Each of the outputs 32 may be different, depending on the specific instructions delivered to each amplifier 36 by controller 44 . Outputs 32 from each amplifier 36 are evaluated by forward and reflected power measuring circuits 46 and delivered to applicators 14 which, in turn, use the output to apply a treatment dosage of electromagnetic energy to the patient. The power level controller 44 individually instructs each amplifier 36 in accordance with specific information received from the field strength detectors located on the applicators 14 . As described in greater detail below, power level controller 44 , in conjunction with multiple control circuits, also provides for automatic disablement of the apparatus when treatment is complete, when treatment dosages are at unacceptable levels, or when inadequate power is being delivered to the apparatus. For multiple applicator embodiments, unit 12 may include a single controller 44 with multiple circuits, each dedicated to a single amplifier 36 , for controlling multiple applicators 14 , or multiple separate and distinct controllers 44 , each having a single circuit for controlling a single applicator 14 . FIG. 3 is a block diagram of the pulse rate generator 34 and treatment energy pulse controller 40 shown in FIG. 2 . Generator 34 includes three major subcircuits. The first subcircuit is a pulse rate timer 64 for generating a controlled frequency of occurrence of the pulse envelope. Timer 64 sets the period, or pulse rate, of treatment dosage. The output of timer 64 is sent to a second subcircuit, the pulse width timer 66 , which produces a single consistently shaped pulse envelope. The output of timer 66 is then used as an enable pulse for the gated high frequency RF oscillator 70 of the pulse generator 34 . Oscillator 70 generates electrical signals reflecting the characteristics defined by the enabling pulse. The generated electrical signal output 38 is then delivered to amplifiers 36 which increase the size or amplitude of the signals in response to instructions received from the power level controller 44 . For specific wound treatments, it has been demonstrated that maximum effectiveness results when the RF pulse rate, RF pulse width, and peak RF power level of the enable pulse are set at specific values. For example, the ED 50 dose for optimum stimulation of human and other mammalian fibroblasts is about 15 mw/cm 2 average RF power, with an ED 99 of about 32 mw/cm 2 , while the Ed 99 for epithelial cells is about 100 mw/cm 2 . These dosages are based upon pulse envelopes with an optimum pulse duration of about 32 microseconds and a repetition rate of about 1,000 pulses per second. For example, in one embodiment particularly effective in treating pressure ulcers, timer 64 is set at between about 1,200-1,500 pulses per second, and timer 66 is set at between about 16-20 microseconds, giving an output of between about 30-40 mw/cm 2 average power. In another effective embodiment, timer 64 is set at between about 900-1,200 pulses per second, and timer 66 is set at between about 30-45 microseconds, giving an output of between about 30-65 mw/cm 2 average power. In another effective embodiment, timer 64 is set at between about 600-1,000 pulses per second, and timer 66 is set at between about 32-60 microseconds, giving an output of between about 30-100 mw/cm 2 average power. Other treatment profiles are possible and can be used without departing from the scope of the present invention. Referring once again to FIG. 3, automatic control of operating parameters (e.g., pulse rate, pulse width, RF power level, treatment time, etc.) is managed by a treatment energy pulse shaper and pulse repetition controller circuit 40 . Circuit 40 includes a custom control logic circuit 72 having numerous treatment profiles preset therein. A treatment mode selector control 74 permits the operator to quickly select one of the stored profiles. Pulse control circuit 76 receives the signal from circuit 72 reflecting the desired pulse rate for the selected profile and sets the pulse rate timer 64 accordingly. Similarly, width control circuit 78 receives the signal from circuit 72 reflecting the desired pulse width for the selected profile and sets the pulse width timer 66 accordingly. Further, an RF power level is selected by the control logic circuit 72 and an appropriate signal reflecting that selection is sent to the power level controller 44 , shown in FIGS. 2 and 5. The ability to easily select and automatically control operating parameters (e.g., pulse rate, pulse width, and RF power level) is a very important feature lacking in previous devices. By employing a control logic circuit 72 , a plurality of treatment RF pulse profiles (combination of specific RF pulse rates, RF pulse widths, and RF power level) can be easily preset during assembly and manufacture. Treatment mode selector control 74 is included to allow the operator to easily select the appropriate treatment profile. In one embodiment, control 74 is a rotory selector witch. Preferably, the positions are clearly labelled as to their function. In another embodiment, control 74 is a touch pad or series of depressible buttons or keys for electronically or otherwise inputting a selection. It is understood that any means for selecting one or more of a number of stored profiles is contemplated by the present invention. In preferred embodiments, the only operator control besides control 74 is the Start/Stop button 80 (FIG. 4 ). In one embodiment of the present invention, the control logic circuit 72 is preset with a single treatment profile. In that embodiment, the actuating means (e.g., start/stop button 80 ) is all that is required to select and start treatment. Where multiple applicators are used, the unit 12 is provided with multiple treatment selector controls 74 , one for each applicator 14 . It is possible, however, to combine those controls in a single structure (e,g., a touch pad). FIG. 4 is a block diagram of treatment timer 48 . To regulate the amount of time, or treatment dosage, that a patient is receiving the applied pulsed RF energy, a digitally controlled treatment timer 48 is provided. The treatment timer 48 is started by pressing an actuator 80 , such as a start/stop push-button, and is stopped by the operator by again pressing the actuator 80 . Pressing actuator 80 sets digital latch 82 . Setting the digital latch 82 starts several actions. First, a signal is sent to the treatment energy pulse controller 40 to enable its operation. Second, a signal is sent to the power level controller 44 to enable its operation. Third, setting the digital latch 82 enables a time base oscillator 84 . The output of oscillator 84 is sent to a multiple stage binary counter 86 , which at its last output stage, produces an extended square wave pulse after a fixed period of time. This square wave pulse is then sent to a timer control 88 , producing exclusive output signals. Timer counter 88 is preset to a predetermined treatment time, automatically controlled by logic circuit 72 , or set by the operator using the treatment selector control 74 . When the timer control 88 counts down to a value of zero, an end of treatment output pulse is initiated and this pulse is then used to reset the digital latch 82 , disable the time base oscillator 84 , and disable the control logic circuit 72 . While the timer control 88 counts down, it is simultaneously sending signals which drive and correctly illuminate a treatment time display panel 90 . The treatment timer 48 can also be stopped by a disable pulse received from the power level controller circuit 44 . The disable signal is automatically generated when an operating deviation in the RF output circuitry is detected. FIG. 5 is a block diagram of a power level controller 44 for incorporation in the present invention. The power level controller 44 is a multi-function circuit that can monitor and control the pulsed RF energy outputs to multiple applicators 14 . Many of the sub-circuits shown in FIG. 5 are repeated for each treatment applicator. For the sake of clarity, FIG. 5 illustrates only one of these sub-circuits, and includes additional circuits that are common for basic treatment applicator operation. FIG. 6 completes the overall interconnections for operation, and illustrates multiple sub-circuits required for, as an example, three treatment applicators 14 . The controlling sub-circuit that permits pulsed RF energy to reach a treatment applicator 14 is the RF power enable circuit 92 . Circuit 92 is activated by an enable signal 94 from the treatment timer 48 and an enable signal 96 from the isolated power supply control 52 . When enabled, the RF power enable circuit 92 sends an RF power enable signal 98 to the RF amplifier power control 100 . Circuit 100 controls the RF power level to the RF power amplifier 36 . When RF power is being transmitted to the treatment applicator pad 14 , the RF power enable circuit 92 switches on an indicator lamp 102 . Forward RF power signals 104 and reflected RF power signals 106 from measuring circuit 46 are delivered to voltage comparators 108 and 110 , respectively. Voltage comparators 108 and 110 allow the setting of maximum forward and reflected power levels. If either of the measured power outputs is above/below its respective set-point level, a disable signal is sent to the RF power enable logic circuit 92 , switching off RF power to one, a few or all low power RF amplifiers 36 , switching off the treatment timer 48 , and sending a signal to an optional alarm circuit 112 . During a high forward or reflected power condition, indicator flashing circuit 114 is enabled which then starts flashing the single service required LED 116 . The actual RF energy that is transmitted from each treatment applicator 14 is measured by a detector located on the treatment applicator (FIG. 11 ). This field strength signal 118 is used to automatically regulate and control the RF output to the treatment applicator 14 . Additionally, signal 118 is evaluated to determine if operation of the apparatus should be halted. Specifically, comparator 120 sets a maximum field strength level, and comparator 122 sets a minimum field strength level. If the measured field strength is outside these limits, a disable signal is sent to the RF power enable logic circuit 92 , switching off RF power to all RF amplifiers 36 , switching off the treatment timer 48 , and sending a signal to an optional alarm circuit 112 . During an out-of-range condition, indicator flashing circuit 114 is enable which then starts flashing the single service required LED. When the treatment applicator 14 is in place, a body proximity sensor switch (FIG. 9) is closed, and the applicator in place LED 124 is illuminated. If this switch inadvertently opens, an indicator flashing circuit 126 is enabled and the check applicator LED 128 flashes. FIG. 6 describes in more detail how one embodiment of the present invention operates. Initially, a crystal controlled oscillator 130 is stimulated following input of a DC supply voltage 132 . The oscillator then generates a sine wave output 134 having a frequency of about 27.12 MHz to a preamplifier 136 controlled by an external switch 138 so that its output 140 consists of pulses of specific duration and repetition rate as controlled by the pulse rate generator and treatment energy pulse shaper and pulse repetition controller 40 . The output of this stage of gain drives another amplification stage 142 which draws no current unless an input signal is present (Class C amplifier). This particular feature is an important improvement in that it is one of the features allowing for the use of a very low power amplifier to drive an effective output treatment RF signal. The output 144 of amplifier stage 142 then drives two additional power amplifiers 146 , 148 , also operating as Class C amplifiers. The Class C operation of additional power amplifiers 146 , 148 also contributes to the ability to use low input power. The output 150 of the final amplifier is applied to the treatment applicator 14 via a coaxial cable connected to port 152 . FIG. 6 further shows one preferred circuit for adjusting the amplifier output. Field strength signal 131 is applied to one input 133 of comparator 135 . The other input 137 of comparator 135 is a preset signal or a voltage from the controller. The output 139 of comparator 135 goes to opeational amplifier 141 . The signal is then amplified further by voltage regulator 143 . Voltage regulator 143 supplies DC power to the RF oscillator 130 and amplifier, thereby adjusting the output of the amplifier and, hence, the treatment dosage. FIG. 7 is a block diagram of an embodiment of the present apparatus 10 having multiple treatment applicators 14 . As previously discussed, the power level controller 44 includes multi-tasking circuits that permit the addition and separate control of multiple treatment applicators 14 . As shown in FIG. 7, the present invention allows for the concurrent treatment of multiple wound sites on a single patient where each wound site requires a different treatment profile. FIG. 7 illustrates the embodiment of multiple sub-circuits that are required for, as an example, three treatment applicator pads. Each autonomous circuit incorporates separate low power class C RF amplifiers 36 and forward and reflected power measuring circuits 46 . Separate indicator lamps 102 , 124 , 128 are provided for applicator in place 27 , check applicator 28 , and treatment power on 29 . Separately controlled RF energy pulses, which are transmitted through the individual forward and reflected power measuring circuits 46 are connected to separate treatment applicators 14 via labeled flexible cables, each applicator 14 having its own detectors and sensors (FIGS. 9 and 10 ). From each treatment applicator 14 , separate signals from the detector and body proximity sensor are sent to individual control circuits in the power level controller 44 to independently monitor and control the RF output level radiating from each treatment applicator 14 . Each control circuit of the power level controller 44 is automatically activated when a treatment applicator 14 is connected to the electromagnetic energy output device. When a treatment applicator 14 is disconnected, or if its body proximity sensor is in an open circuit condition, the associated control circuit of the power level controller 44 is automatically de-activated. FIG. 8 is a block diagram of an isolated power supply assembly 52 of the present invention. Unit 12 is powered by a source 18 , such as an internal battery pack, which can be periodically recharged using a peripheral AC line cord. An isolated power supply control 158 continuously checks the voltage from the battery pack 18 , advises the operator when it is time for re-charging, and disables all RF output functions when the battery voltage drops below a minimum level. Specifically, direct battery voltage is sensed by amplifier 160 . The output of amplifier 160 is monitored by a display driver circuit 162 . Circuit 162 is wired to illuminate the low LED 164 when the battery voltage is below a defined voltage level and requires re-charging, to illuminate the OK LED 33 when the battery voltage is at an acceptable voltage level, and to flash the high LED 34 if the battery voltage is sensed to be higher than an acceptable limit. If the battery voltage is OK, an output signal 170 is sent to the power level controller 44 , enabling the RF power enable circuitry. The monitoring of battery voltage is very important because it assures that electronic circuits are being powered with adequate supply voltage, that treatment RF dosage is not compromised due to low battery voltage, and that electronic circuits (including battery) are not stressed or damaged due to excessively high or low battery voltage. FIGS. 9-13 show preferred embodiments of the applicator 14 of the present invention. As shown in FIGS. 9-13, the applicator 14 is a monolithic assembly of one or more circuits having a fixed capacitance. This important feature renders the device substantially unaffected by impedance, capacitance and other related affects associated with locating an electromagnetic energy applicator in proximity to a patient's body. Unlike prior art devices which require manual adjustment of the capacitor(s) in the applicator at the treatment site, the present invention has a capacitance fixed by the manufacturer, thereby rendering the device user friendly. Each applicator includes one or more circuits (such as etched copper printed circuit, stamped wire circuit, etc.) formed on a single substrate, such as an assembly comprising one or more circuit boards. Preferably, the circuits are etched or otherwise located on opposite surfaces of a single circuit board. Referring to one embodiment of the present applicator shown in FIGS. 9-11, applicator 14 includes a single circuit 174 that is laminated between insulating sheets of flexible Kapton 178 , or similar material with high dielectric properties. Circuit 174 includes an etched inductor 180 , a fixed capacitor 192 connected in parallel with inductor 180 , a signal detector 182 , and a body proximity sensor 184 . A ground plane 176 , such as a solid RF copper shield, is located directly below the first etched printed circuit 174 . Circuit 174 and plane 176 are brought out to a connection interface 186 to which a flexible and shielded, multi-conductor cable 188 is permanently attached. Connection to the generator unit 12 is made through connector 190 , shown in FIG. 10 . That composite assembly defines the completed applicator 14 . FIGS. 12 and 13 show an alternative embodiment of the applicator described above having multiple circuits 174 and 177 . In the applicator 14 , the upper circuit 174 forms the secondary of an RF transformer. The primary circuit 177 is etched on the other side of this two sided board. The upper circuit 174 (secondary), which is a multi-turn spiral, has a fixed, surface mount capacitor 192 connected in parallel with it to form a tank circuit resonant at 27.12 Mhz. Circuit 177 (primary), comprising a single turn, has a fixed, surface mount capacitor connected in series. The ends of this series-resonant circuit are brought out to a connection interface 186 from which it is then connected to controller 44 and RF amplifier 36 . The function of the LC tank circuit is to radiate a pulsed RF energy in the form of a closed and concentrated RF electromagnetic energy field. Circuit 174 also includes detector 182 . Detector 182 is brought out to the connection interface 186 and serves as an RF energy measuring element, and as such, measures, monitors, regulates and controls the magnitude of the pulsed electromagnetic energy field, or treatment dosage, as it radiates out from the applicator. The returned signal level from detector 182 is sent to the power level controller 44 , where it is used as a feedback control signal. If at any time, detector 182 measures radiated electromagnetic energy output level above or below an acceptable RF level, a service required lamp (FIG. 3) will flash and the power level controller disables the RF energy output. It should be understood that any appropriate detector 182 , such as a germanium diode, may be used without departing from the scope of the present invention. Applicator 14 also includes a body proximity sensor switch 184 . Switch 184 confirms that applicator 14 is in place and attached to the patient and that the emitted pulsed RF energy field is being efficiently coupled from the applicator 14 to the patient. In use, applicator 14 is either placed under the patient, in close proximity to the patient's wound, or wrapped around the limb of a patient and attached with fasteners, or is placed over a wound, again being held in place with fasteners. If applicator 14 is secured correctly, the body proximity sensor switch 184 closes, indicating to the power level controller 44 that applicator 14 is in place, and a lamp indicating applicator in place 27 is activated. If any time during treatment, the body proximity sensor switch 184 opens, indicating that applicator 14 is not in body contact, a check applicator 28 lamp flashes and the power level controller 44 disables the RF energy output. Unlike many prior art devices, which are magnetic field based and, in some instances, prevent the electrical field component of the electromagnetic energy from being transmitted, the present invention relies on electrical field-based information for effective operation. Electrical field strength detector 182 included in each applicator 14 produces a DC voltage as a function of the actual field strength being transmitted from applicator 14 . This DC voltage is transmitted in a reverse manner (antidromically) through the same coaxial cable 188 which carries the RF signal from amplifier 36 to applicator 14 . In this manner, only one cable is required to carry and process both the RF power and RF detection signals. This represents a substantial improvement over the prior art, none of which have a signal detection means at the level of the actual RF signal output, and none of which carry this detection signal over the same cable as used for transmitting the RF signal. In the RF generator 30 , this DC voltage (detection signal 118 ) is compared to a reference DC voltage which represents the desired field strength. The output of the comparator 120 , 122 drives suitable amplifiers 100 which control the DC power supply voltage to the RF circuits, thus controlling the forward RF power. The field strength, being a function of the RF power, is thereby accurately controlled and maintained. This is a significant improvement not found in existing devices, and represents the first capability to accurately deliver, monitor and automatically control the actual RF power delivered to the tissue being treated, thereby ensuring an accurate dosage delivery and dosimetry system. The circuits are located on a single substrate, such as a circuit board. The substrate is preferably thin and may be flexible or rigid and constructed from one or more sheets. When multiple circuits are included (FIGS. 12 and 13 ), the circuits are preferably concentrically located on the substrate. While it is not necessarily required that the circuits be exactly concentric, best results are achieved when the two circuits are as close to concentrically positioned as possible. Preferably, the applicator 14 is approximately 6 inches by 8 inches by less than 1 inch thick, and is housed within a waterproof outer covering. The outer surface is water proof, bacterial resistant and designed to be placed directly on the patient or on top of any standard dressings used over the area to be treated. The generating unit 12 is about 2.5 inches by 5 inches by 8 inches, and has a weight of less than three pounds. In a preferred embodiment, unit 12 includes a display panel which contains the operating switch or button, a treatment time remaining display, a light which is on during treatment to notify the operator that treatment is occurring, and a service light which comes on if the unit needs servicing. Unit 12 is a hand-held one, which is easily transported from site to site. Applicators 14 are self supporting structures which do not require any mechanical support structure for positioning. Indeed, the only means connecting the applicator 14 to the generating unit 12 is a cable. Reference throughout this description to LEDs and other specific indicators was made for descriptive purposes only. It is understood that other indicating means for informing users of operational conditions are interchangeable with the specific indicators disclosed herein. Treatment dosages of electromagnetic energy are applied as follows. The control logic circuit is programmed with treatment profiles which enable the oscillator to provide a treatment dosage of about 1-300 mw/cm 2 . The preferred treatment profile is administered twice a day, eight to twelve hours between treatments, for thirty minutes. Indeed, the unit is preferably factory preset to deliver treatment for thirty minutes and requires no operator adjustment. When ready, the “start/stop” button is pressed. When this button is pressed, the indicator light indicates therapy has started and an electromagnetic energy dosage is generated and delivered to the treatment site. The electrical field at the treatment site is continuously monitored, with information being delivered back to the generating unit to control the dosage level. At the end of thirty minutes, the unit turns itself off and the power indicator light becomes dark. The following are representative examples of treatments administered using the present invention. EXAMPLE 1 This example describes treatment on fibroblasts, a cell type critical to the wound healing process, using the present invention. Immortalized (Rat-2) or primary (human SA-1) fibroblasts were plated 24 hours prior to treatment in 96-well trays at initial densities from 500-10,000 cells per well in Dulbecco's modified Eagle's medium supplemented with high (10% horse, 5% fetal calf) or low (0,5% fetal calf) serum. Cells were treated either with the present invention or a control. The treatment parameters for the present invention, i.e., pulse duration, peak power, average power (dose) and rate of pulse presentation, were systematically varied. Optimal average power, pulse duration and repetition rate were shown to be about 32 mw/cm 2 , about 32 μs, and a mean of about 1,000 pps respectively. Systematic changes in proliferative response as a function of changes in parameter value were found for all conditions. These results demonstrate that specific characteristics of the present invention critically influence the efficacy of response, and provide a clear picture of the optimum control logic parameters necessary for efficacious treatment of wounds in a clinical setting. EXAMPLE 2 This example evidences the dose- and time-dependent effects of treatment using the present invention on Rat-2 immortalized and SA-1 human primary fibroblasts in culture. Cells plated in multi-well trays at a series of densities in medium supplemented with serum at different concentrations were treated using the present invention at an average dose of between about 0-178 mw/cm 2 . Other cells were treated with 32 mw/cm 2 for 0 to 60 minutes. After 24 hrs, cells were quantitated directly, via mitochondrial enzyme activity or crystal violet staining. When control logic circuits were preset to provide a pulse width of 32 microseconds and a pulse rate of about 600-1,000 pulses per second, proliferation was significantly enhanced (50-200%, p<0.001) with an ED 50 of 15 mw/cm 2 and an ED 99 of 32 mw/cm 2 . Maximal proliferation occurred following 15-60 min treatment time with ½-maximal effects at 8 min. These results reveal optimal and minimal doses and times of treatment to trigger proliferation response. EXAMPLE 3 Example 3 describes a novel and proprietary method of accelerating healing to closure of chronic cutaneous wounds. It is clear that effects seen clinically and in vitro are based upon enhanced pro-proliferative effects. Evidence for a specific mechanism for enhanced cell proliferation has now been obtained. Rat-2 immortalized or SA-1 human primary fibroblasts seeded at initial densities from 500-10,000 cells per well were treated with a 32 mw/cm 2 dose or sham treated (naïve). At times ranging from 0 to 16 hr post treatment, medium was removed from wells containing treated cells and transferred to wells containing naïve cells. To define positive and negative controls, respectively, some treated cells were kept in medium throughout, and some naïve cells were not exposed to treated medium. At 24 hr posttreatment, all cells were crystal violet stained and quantified spectrophotometrically. Modest proliferation above control levels was observed for cells treated with the present invention, even if medium was removed immediately after treatment, but larger and time-dependent increases in numbers of cells treated with the present invention were obtained if medium was left on those cells for 5-16 hours. Proliferation of naïve cells was also observed if they received treated cell medium 0-16 hr after treatment. These studies show that diffusible entities promoting cell proliferation are released into and conditions cell culture medium upon treatment using the present invention. EXAMPLE 4 This example describes a clinical study wherein a novel, noninvasive endogenous pharmacotherapeutic wound treatment was realized. Twenty High or Moderate Risk patients with Stage II, III or IV pressure ulcers were entered into this study. This group presented with very severe wounds relative to the total pressure sore population. Mean study wound surface area was 17.6±2.1, compared to a population average of 6.6±1.3, and all patients were severely compromised in nutritional and medical status. Patients were treated for thirty minutes twice daily, with a dose equal to about 32 mw/cm 2 measured at a distance of about 6 cm from the applicator surface. All patients responded positively to the present treatment. Stage II wounds closed in about 3-5 weeks, compared to a norm of about 8 weeks for smaller wounds. Stage III and Stage IV wounds showed similar acceleration of wound healing. Average rate to closure was about 28 mm 2 /day, compared to population norms of 3-9 mm 2 /day for patients not treated with the present method. A highly novel finding is that tissue repair was stimulated through several layers of the wound bed, with rapid loss of necrotic tissue and simultaneous robust granulation. According to these data, the present invention reduces the time associated with wound healing by 50%. The above examples are provided by way of illustration, and are not intended to limit the scope of the present invention. It should be understood that references to wound treatment are not limited to the induction of granulation, epitheliation and vascularization at a wound site, but also includes restoring nutrient load to a wound site, thereby inducing synthesis of growth factors, inducing the synthesis, proliferation and release of fibroblasts, epithelial, endothelial, vascular, muscle and neuronal cell types, inducing macrophage activity in a wound site, increasing mitogenic stimuli, increasing concentration of and inducing effective biological activity of growth factors within a wound site, delivering multiple growth factor therapy to a tissue, altering activity of cell cycle dependent proteins, inducing synthesis and activity of signal transduction molecules, and inducing gene expression in a tissue, among other events. Further, while the present invention is described in terms of human treatment methods, it should be understood that treatment, as used herein, encompasses laboratory applications and procedures as well as veterinary applications and the like. From the foregoing, it will be appreciated by those skilled in the art that the present invention provides a particularly effective and advantageous method of and apparatus for overcoming many of the limitations associated with the treatment of patients using electromagnetic energy. It will also be readily appreciated by one with ordinary skill in the art to use the method and apparatus of the present invention in other applications, such as veterinary applications. Although certain presently preferred embodiments of the present invention have been specifically described herein, it will be apparent to those skilled in the art to which the invention pertains that variations and modifications of the various embodiments shown and described herein may be made without departing from the spirit and scope of the invention.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of U.S. patent application Ser. No. 13/983,808, filed Aug. 6, 2013, which is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2012/052640 filed Feb. 16, 2012, which claims priority to European Patent Application No. 11155032.3 filed Feb. 18, 2011 and U.S. Provisional Application No. 61/445,610 filed Feb. 23, 2011. The entire disclosure contents of these applications are herewith incorporated by reference into the present application. TECHNICAL FIELD [0002] The invention relates to an auto-injector for administering a dose of a liquid medicament. BACKGROUND [0003] Administering an injection is a process which presents a number of risks and challenges for users and healthcare professionals, both mental and physical. [0004] Injection devices (i.e. devices capable of delivering medicaments from a medication container) typically fall into two categories—manual devices and auto-injectors. [0005] In a manual device—the user must provide the mechanical energy to drive the fluid through the needle. This is typically done by some form of button/plunger that has to be continuously pressed by the user during the injection. There are numerous disadvantages to the user from this approach. If the user stops pressing the button/plunger then the injection will also stop. This means that the user can deliver an underdose if the device is not used properly (i.e. the plunger is not fully pressed to its end position). Injection forces may be too high for the user, in particular if the patient is elderly or has dexterity problems. [0006] The extension of the button/plunger may be too great. Thus it can be inconvenient for the user to reach a fully extended button. The combination of injection force and button extension can cause trembling/shaking of the hand which in turn increases discomfort as the inserted needle moves. [0007] Auto-injector devices aim to make self-administration of injected therapies easier for patients. Current therapies delivered by means of self-administered injections include drugs for diabetes (both insulin and newer GLP-1 class drugs), migraine, hormone therapies, anticoagulants etc. [0008] Auto-injectors are devices which completely or partially replace activities involved in parenteral drug delivery from standard syringes. These activities may include removal of a protective syringe cap, insertion of a needle into a patient's skin, injection of the medicament, removal of the needle, shielding of the needle and preventing reuse of the device. This overcomes many of the disadvantages of manual devices. Injection forces/button extension, hand-shaking and the likelihood of delivering an incomplete dose are reduced. Triggering may be performed by numerous means, for example a trigger button or the action of the needle reaching its injection depth. In some devices the energy to deliver the fluid is provided by a spring. [0009] US 2002/0095120 A1 discloses an automatic injection device which automatically injects a pre-measured quantity of fluid medicine when a tension spring is released. The tension spring moves an ampoule and the injection needle from a storage position to a deployed position when it is released. The content of the ampoule is thereafter expelled by the tension spring forcing a piston forward inside the ampoule. After the fluid medicine has been injected, torsion stored in the tension spring is released and the injection needle is automatically retracted back to its original storage position. [0010] High viscosity medicaments require high forces for expelling them through the relatively thin injection needle. To achieve these forces strong drive springs are needed. This can lead to a high impact felt by the user when inserting the needle into the skin and to high forces felt by the user when triggering the injection. SUMMARY [0011] It is an object of the present invention to provide an improved auto-injector and an improved method for operating an auto-injector. [0012] The object is achieved by an auto-injector according to claim 1 and by a method according to claim 13 . [0013] Preferred embodiments of the invention are given in the dependent claims. [0014] In the context of this specification the term proximal refers to the direction pointing towards the patient during an injection while the term distal refers to the opposite direction pointing away from the patient. The term inwards refers to a radial direction pointing towards a longitudinal axis of the auto-injector whereas the term outwards refers to the opposite direction radially pointing away from the longitudinal axis. [0015] According to the invention an auto-injector for administering a dose of a liquid medicament comprises: [0016] a tubular chassis telescopable in a tubular case, [0017] a carrier subassembly comprising a tubular carrier slidably arranged relative to the chassis inside the case, the carrier adapted to contain a syringe with a hollow injection needle, a drive spring and a plunger for forwarding load of the drive spring to a stopper of the syringe, wherein the syringe is lockable for joint axial translation with the carrier, [0018] a trigger button arranged distally or laterally in or on the case, [0019] a control spring arranged around the carrier, [0020] a needle extension control mechanism for coupling a proximal end of the control spring to either the carrier for advancing it for needle extension or to the chassis for needle retraction depending on the relative axial position of the carrier and the chassis, [0021] a plunger release mechanism arranged for releasing the plunger when the carrier has at least almost reached a extended proximal position, [0022] a detent mechanism arranged for coupling the chassis to the carrier for joint axial translation relative to the case, wherein the detent mechanism is arranged to decouple the chassis from the carrier upon actuation of the trigger button thus allowing the carrier to move relative to the chassis so as to cause the needle extension control mechanism to switch the proximal end of the control spring to the carrier for needle extension, [0023] a syringe retraction control mechanism arranged for coupling a distal end of the control spring to either the carrier for needle retraction or to the case otherwise. [0024] The carrier subassembly with the integrated drive spring allows for employing a strong drive spring without any impact on the user when triggering the auto-injector or during needle extension since these actions are achieved or opposed by the control spring which can be specified considerably weaker than the drive spring. This allows for delivering highly viscous medicaments. [0025] There are a number of significant benefits of separating the functions between the drive spring and the control spring in this way. The auto-injector is always needle safe, i.e. the needle can be retracted before the injection is complete. The reliability of the auto-injector is improved as the components for needle advance and retraction are not loaded by the high impact of a freely expanding high force drive spring. The auto-injector is well suited to serve as a platform as the drive spring can be swapped to deliver different viscosity drugs without affecting the insertion or retraction functions. This is particularly advantageous for high viscosity fluids. [0026] Releasing the drive spring upon the needle reaching an advanced proximal position, e.g. when the needle is advanced to a corresponding injection depth, avoids a so called wet injection, i.e. medicament leaking out of the needle which is a problem in conventional art auto-injectors, where both needle extension and injection are achieved by pushing on the stopper. The auto-injector according to the invention solves the wet injection problem by the separate springs for translation of the carrier and for drug delivery. [0027] The auto-injector according to the invention has a particularly low part count compared to most conventional auto-injectors thus reducing manufacturing costs. The arrangement with separate control spring and drive spring for fluid injection allows for using one design for different viscosity liquids by just changing the drive spring, and for different volumes just by changing the length of the plunger. This is an advantage over conventional art designs where the main spring also powers needle extension and/or retraction. [0028] In the context of this specification the chassis is generally considered as being fixed in position so motion of other components is described relative to the chassis. [0029] In an initial as delivered state of the auto-injector the proximal end of the control spring is coupled to the chassis by the needle extension control mechanism while the distal end is coupled to the case by the syringe retraction control mechanism, release of the drive spring is prevented by the plunger release mechanism, decoupling of the chassis from the carrier is prevented by the detent mechanism. [0030] In order to trigger the auto-injector the case has to be translated in the proximal direction relative to the chassis against the force of the control spring. When the case has at least almost reached an advanced proximal position the detent mechanism is unlocked thereby allowing translation of the carrier relative to the chassis. Preferably this position has been reached, when the case has moved 85%-98% of its total proximal extension. The relative translation of the case and the chassis could be achieved, e.g. by fixing the chassis and moving the case. For the purpose of injection, e.g., the chassis may be fixed by pressing against an injection site, e.g. a patient's skin. Hence a user, e.g. the patient or a caregiver, could grab the case with their whole hand and push the chassis protruding from the proximal end against the injection site, thereby translating the case relative to the chassis in proximal direction and triggering the auto-injector in a way described above. [0031] The carrier now is unlocked to be translated in the proximal direction. As the carrier translates in the proximal direction relative to the case and to the chassis it thereby switches the needle extension control mechanism depending on the relative position of the carrier in the chassis so as to decouple the proximal end of the control spring from the chassis and couple it to the carrier, thereby releasing the control spring for advancing the carrier for needle extension. For the purpose of injection, e.g., the user could manually depress a trigger button coupled to the carrier forcing the carrier in the proximal direction. This would cause the needle to be extended according to the needle extension control mechanism described before. Again, for purpose of injection, the user pushing the injector against an injection site could press the trigger button thereby translating the carrier in the proximal direction relative to the case and the chassis thereby switching the needle extension control mechanism as described before. Advancing the carrier under the force of the control spring would then result in advancing the needle into the skin. [0032] Alternatively the control spring could initially be coupled to the carrier by the needle extension control mechanism so that the carrier would be immediately advanced when the detent mechanism is unlocked by translation of the case into the advanced position. [0033] As the needle translates with the carrier subassembly to an extended proximal position, where it is no longer needle safe, the drive spring is released by the plunger release mechanism thereby allowing the drive spring to advance the plunger and the stopper for at least partially expelling the medicament. This release of the drive spring is preferably triggered by the carrier reaching a predefined relative position within the case. This position is reached, when the carrier has at least almost reached the extended proximal position. Preferably, this position is at 85% to 98% proximal extension. If, for example, the extension length is 1 cm the position would fall into the range of 8.5 mm-9.8 mm proximal extension length [0034] For the purpose of injection the extended proximal position may correspond to an intended injection depth. Hence the drive spring could be released by the plunger release mechanism once the injection depth is substantially reached thereby allowing the drive spring to advance the plunger and the stopper for at least partially delivering the medicament. [0035] If the auto-injector is removed from the injection site after the stopper has bottomed out in the syringe or at any point during injection, the case is translated in the distal direction under load of the control spring relative to the carrier subassembly. [0036] The needle retraction is triggered by moving the case in distal direction relative to the chassis and the carrier under the force of the control spring. As the case reaches a defined position relative to the carrier the proximal end of the control spring is decoupled from the carrier and coupled to the chassis by the needle extension control mechanism. Furthermore the distal end of the control spring is decoupled from the trigger sleeve and coupled to the carrier by the syringe retraction control mechanism. The sequencing of this switching is critical as retraction will fail if both collars are attached to the carrier at the same time. This is overcome by separating the switching of the collars by a significant displacement of the case, which provides for first switching the needle extension control mechanism and then the syringe retraction control mechanism, e.g. [0037] As the control spring now pushes against the chassis in the proximal direction and against the carrier in the distal direction the carrier subassembly is retracted into the chassis into a needle safe position by the control spring, where the proximal end of the needle is covered. As this retraction is triggered by the relative position between case, chassis, and carrier, it is particularly independent from expelling the medicament. For the purpose of injection this position of the case relative to the carrier could be reached, e.g. if the auto-injector is removed from the injection site. When, e.g., the user still grabbing the case with their whole hand and pushing the chassis protruding from the proximal end against the injection site move their hand in distal direction, the case will be moved in distal direction relative to the carrier and the chassis and the mechanism will be triggered as described before. The needle will thus be retracted from the injection site under the force of the control spring. [0038] According to one embodiment the needle extension control mechanism may comprise a first collar biased by the control spring in the proximal direction, wherein at least one resilient beam is proximally arranged on the first collar, wherein respective recesses are arranged in the carrier and case, wherein a transversal extension of a head of the resilient beam is wider than a gap between the carrier and the chassis causing the head of the resilient beam to abut a distal face on the recess in the chassis while being prevented from deflecting in an inward direction by the carrier or to abut a distal face on the recess in the carrier while being prevented from deflecting in an outward direction by the chassis thereby forwarding load from the control spring to the carrier for needle extension, wherein the resilient beam is arranged to be switched between the chassis and the carrier by ramped engagement of the head to the distal faces under load of the control spring depending on the relative longitudinal position between the chassis and the carrier. As the head of the resilient beam may be inwardly and outwardly ramped it may be referred to as an arrowhead. [0039] The plunger release mechanism may comprise at least one resilient arm on the carrier arranged to be in a ramped engagement to the plunger so as to disengage them under load of the drive spring, wherein a peg protrudes from a distal end face of the trigger button in the proximal direction in a manner to support the resilient arm preventing disengagement of the carrier from the plunger and thus release of the drive spring when the carrier is in a distal position. The trigger button is arranged to remain in position relative to the case when the carrier is translated for advancing the needle. That means, the trigger button, initially coupled to the carrier, pushes the carrier in the proximal direction when depressed. As soon as the control spring takes over further advancing the carrier the trigger button may abut the case and decouple from the carrier, staying in position as the carrier moves on. Hence the resilient arm is pulled away from the peg thus allowing deflection of the resilient arm due to the ramped engagement under load of the drive spring for disengaging the plunger from the carrier and releasing the drive spring for drug delivery when the carrier has reached a predefined position during needle advancement. [0040] The detent mechanism may be arranged to provide a resistive force which has to be overcome to advance the carrier in the proximal direction for needle extension. The carrier may be coupled to a trigger button and the force pushing the trigger button has to exceed the resistive force of the detent mechanism. E.g., once the user applies a force on the trigger button which exceeds a pre-determined value the detent mechanism releases, initiating the injection cycle. If the pre-determined value is not overcome the detent mechanism pushes the carrier and trigger button back into their prior position. This ensures that the auto-injector is always in a defined state, either triggered or not triggered, not half triggered by the user hesitating. [0041] The detent mechanism may also be arranged to provide a resistive force resisting translation of the carrier in the distal direction relative to the chassis for keeping the carrier in a defined position in a transitional state with both ends of the control spring decoupled from the carrier. This transitional state may be required for retracting the needle on removal from the injection site. As the carrier is biased against the injection site by the control spring before removal from the injection site it has to be decoupled from the proximal end of the control spring and coupled to the distal end for retraction. The sequencing of this switching is critical as retraction will fail if both ends of the control spring are attached to the carrier at the same time. This is overcome by separating the switching of the ends by a significant displacement of the case, which moves in the distal direction relative to the chassis on removal of the injection site under load of the control spring. As the switching of the distal end of the control spring to the carrier depends on the relative position of the case to the carrier the carrier has to be fixed in the transitional state which is achieved by the detent mechanism. [0042] In one embodiment the detent mechanism comprises a resilient beam on the chassis and a rhomboid ramp member on the carrier, the resilient beam being essentially straight when relaxed and having a first beam head arranged to interact in a ramped engagement with a proximal fourth ramp or a distal fifth ramp on the rhomboid ramp member in such a manner that application of a translative force on the carrier relative to the chassis in the proximal direction with the first beam head engaged to the fourth ramp deflects the resilient beam in one transversal direction, e.g. outwards when a predetermined value of the translative force, at least depending on the resilience of the resilient beam, is overcome so as to allow the first beam head to travel along one transversal side of the rhomboid ramp member on continued relative translation of the components. The beam head may protrude transversally from the resilient beam in a manner to distort the resilient beam by lever action when pushed against the rhomboid ramp member thereby also defining the predetermined value of the translative force to be overcome by the carrier. Furthermore, the contacting faces of the first beam head and the rhomboid ramp member may have their friction adapted to define the required force by appropriately choosing their shape and material properties. The resilient beam is allowed to relax when the first beam head has reached the fifth ramp thereby engaging it in a manner that application of a translative force on the carrier in the distal direction deflects the resilient beam in the other transversal direction, e.g. inwards when a predetermined value of the translative force, at least depending on the resilience of the resilient beam, is overcome so as to allow the first beam head to travel along the other transversal side of the rhomboid ramp member on continued translation of the carrier. The first beam head may also be allowed to relax behind the fourth ramp at the end of this motion for preventing the carrier from being advanced again, e.g. when the auto-injector is being heavily shaken after use. [0043] It goes without saying that the positions of the resilient beam on the chassis and the rhomboid ramp member on the carrier may be switched without altering the function of the detent mechanism. [0044] When the auto-injector or the syringe is assembled a protective needle sheath may be attached to the needle for keeping the needle sterile and preventing both, damage to the needle during assembly and handling and access of a user to the needle for avoiding finger stick injuries. Removal of the protective needle sheath prior to an injection usually requires a relatively high force for pulling the protective needle sheath off the needle and needle hub in the proximal direction. In order to maintain pre injection needle safety and prevent exposure of the needle translation of the syringe in the proximal direction due to this force has to be avoided. For this purpose the case may be arranged to lock the detent mechanism prior to being translated in the proximal direction relative to the chassis when the chassis is being pressed against the injection site so as to avoid translation of the carrier. This may be achieved by a rib in the case preventing deflection of the resilient beam of the detent mechanism by supporting it outwardly. Translation of the case is translated into the advanced position in the proximal direction on contact to the injection site is arranged to unlock the detent mechanism rendering it operable. This may be achieved by the rib being moved with the case so as to no longer outwardly supporting the resilient beam of the detent mechanism. In order to ensure that the case is not moved in the proximal direction unlocking the detent mechanism before the protective needle sheath is removed a cap may be attached to the proximal end of the case so as to make the chassis inaccessible before the cap is removed. The cap preferably engages the protective needle sheath by means of a barb in a manner to remove the protective needle sheath when the cap is being pulled off the auto-injector. In order to facilitate removal of the cap it may have a profiled surface mating with a surface on the case so that the cap is pulled off when rotated. The barb may be connected to the cap in a manner allowing them to rotate independently so as to avoid torque on the protective needle sheath when the cap is rotated in order not to distort the needle inside the protective needle sheath. [0045] The distally arranged trigger button may be at least initially coupled to the carrier, wherein the case is arranged to abut the trigger button in the initial state preventing depression of the trigger button. On translation of the case into the advanced position when the chassis is being pressed against the injection site the trigger button remains coupled to the carrier thus emerging from the case which has been moved relative to the chassis, carrier and trigger button so as to allow depression of the trigger button for starting an injection cycle. Thus a sequence of operation is defined for the auto-injector to be actuated, first pressing it against the injection site and then to push the trigger button. This reduces the risk of finger stick injuries particularly if the user were to be confused which end of the auto-injector to apply against their skin. Without a sequence the user would risk inserting the needle into their thumb which is significantly less probable with the forced sequence. [0046] The syringe retraction control mechanism may comprise a second collar bearing against the distal end of the control spring and having a resilient proximal beam with a second beam head having an inward boss. The second beam head is arranged to be in a ramped engagement with a second case detent in the case in a manner ramping the second beam head in the inward direction under load of the control spring in the distal direction. The inward boss is arranged to inwardly abut the carrier for preventing inward deflection of the second beam head and keep the second collar locked to the case. A third recess is arranged in the carrier for allowing the inward boss to be inwardly deflected on translation of the case in the distal direction relative to the carrier on removal of the auto-injector from the injection site. [0047] In an alternative embodiment the first collar and/or the second collar may also be threaded to one of the components which they are intended to couple to the control spring wherein the case would be arranged to prevent the threads from decoupling in some relative longitudinal positions while allowing the collar to rotate out of the threaded engagement in other relative longitudinal positions so as to allow the collars to switch to the respective other component to be coupled to the control spring. [0048] In an alternative embodiment the trigger button may be arranged distally, wherein the case is arranged as a wrap-over sleeve trigger having a closed distal end face covering the trigger button. In an initial state a clearance is provided between the distal end face of the sleeve trigger and the trigger button allowing for some travel of the sleeve trigger against the bias of the control spring in the proximal direction in a first phase before abutting the trigger button. As soon as the sleeve trigger has contacted the trigger button the trigger button is pushed by the sleeve trigger on further translation in a second phase. This embodiment allows for keeping the majority of the components of the auto-injector while only the described features need modification allowing to customize a platform device to particular requirements. An auto-injector with a sleeve trigger is particularly well suited for people with dexterity problems since, as opposed to conventional art auto-injectors, triggering does not require operation of small buttons by single fingers. Instead, the whole hand is used. [0049] Retraction of the needle requires the user to lift the auto-injector far enough from the injection site to allow the case or sleeve trigger to translate back in the distal direction to switch the control spring. As it may be difficult for the user to know if the injection is finished or not a releasable feedback component may be provided, capable of, upon release, generating an audible and/or tactile feedback to the user, wherein the feedback component is arranged to be released when the plunger reaches a position relative to the syringe in which the stopper is located in proximity of a proximal end of the syringe, i.e., e.g., when the injection is at least almost finished. The released feedback component then impacts on a housing component, such as the case, sleeve trigger or trigger button indicating the end of the injection. Impacting a directly accessible component allows for high perceptibility of the noise and direct access to the user's hand or finger for generating the tactile feedback. Preferably the feedback component may impact the trigger button which may be shaped as a drum for providing a loud noise. [0050] The needle extension length or depth is preferably defined by the carrier relative to the chassis not relative to the case, so if the user flinches or fails to hold the auto-injector hard against the injection site, only the case will move in the distal direction while the injection depth remains constant. As long as this case motion does not exceed a set distance the case does not yet switch the control spring for needle retraction. [0051] The auto-injector may be operated by a number of key mechanical operations: [0052] The case is advanced relative to the chassis compressing the control spring giving the user the impression of depressing a skin interlock sleeve. All other components remain in the same place during case advance resulting in the trigger button appearing from the distal end of the case. [0053] The user pushes the trigger button which can now be operated. Button depression directly moves the carrier and hence the drive sub-assembly in the proximal direction a set distance until the control spring takes over via the first collar and fully extends the needle, e.g. inserts the needle into the injection site. [0054] The trigger button stops on the distal end of the case as the carrier continues translating in the proximal direction. The motion of the carrier relative to the trigger button is used to release the drive spring just before full insertion depth is reached, e.g. by pulling a peg on the trigger button out of the carrier thus allowing the plunger to move. The drive spring drives the plunger down the syringe barrel expelling the medicament. [0055] A feedback mechanism is released when the plunger is near the end of travel shortly before the stopper bottoms out in the syringe, providing audible and/or tactile indicator of the end of injection to the user. [0056] The needle remains fully extended until the user moves the case back a set distance relative to the chassis at which point the second collar decouples from the case and couples to the carrier while the first collar decouples from the carrier and couples to the chassis thus allowing the control spring to retract the carrier and hence the needle. [0057] The auto-injector may preferably be used for subcutaneous or intra-muscular injection, particularly for delivering one of an analgetic, an anticoagulant, insulin, an insulin derivate, heparin, Lovenox, a vaccine, a growth hormone, a peptide hormone, a proteine, antibodies and complex carbohydrates. The auto-injector may preferably be adapted to be used for injecting a liquid medicament with high viscosity, e.g. liquid solutions of antibody medicaments. [0058] The term “medicament”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, [0059] wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, [0060] wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, [0061] wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, [0062] wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4. [0063] Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin. [0064] Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin. [0065] Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2. [0066] Exendin-4 derivatives are for example selected from the following list of compounds: H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2, H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2, des Pro36 [Asp28] Exendin-4(1-39), des Pro36 [IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or des Pro36 [Asp28] Exendin-4(1-39), des Pro36 [IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39), des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39), [0067] wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative of the sequence H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2, des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2, des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2, H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2; [0068] or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative. [0069] Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin. [0070] A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. [0071] Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCl or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are described in “Remington's Pharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology. [0072] Pharmaceutically acceptable solvates are for example hydrates. [0073] The drive spring and control spring may be compression springs. However, they may likewise be any kind of stored energy means such as torsion springs, gas springs etc. [0074] 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 [0075] 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 limitive of the present invention, and wherein: [0076] FIGS. 1A-B show two longitudinal sections of an auto-injector in different section planes in a state prior to use, [0077] FIGS. 2A-B show two longitudinal sections of the auto-injector after removal of a cap and a protective needle sheath, [0078] FIGS. 3A-B show two longitudinal sections of the auto-injector with the case moved in proximal direction relative to the chassis, [0079] FIGS. 4A-B show two longitudinal sections of the auto-injector with a trigger button depressed, [0080] FIGS. 5A-B show two longitudinal sections of the auto-injector during needle extension, [0081] FIGS. 6A-B show two longitudinal sections of the auto-injector with the needle in extended proximal position, [0082] FIGS. 7A-B show two longitudinal sections of the auto-injector during expelling the medicament, [0083] FIGS. 8A-B show two longitudinal sections of the auto-injector where the stopper is located in proximity of a proximal end of the syringe, [0084] FIGS. 9A-B show two longitudinal sections of the auto-injector where the case is moved in distal direction relative to the chassis, [0085] FIGS. 10A-B show two longitudinal sections of the auto-injector with the needle retracted into a needle safe position, [0086] FIGS. 11A-D show schematic views of a detent mechanism for controlling movement of a carrier relative to a chassis of the auto-injector in four different states, [0087] FIGS. 12A-F show schematic views of a needle extension control mechanism for controlling movement of a first collar in six different states, [0088] FIGS. 13A-C show schematic views of a syringe retraction control mechanism in three different states [0089] FIGS. 14A-C show schematic views of a feedback release mechanism for audibly and/or tactily indicating the end of injection in three different states, [0090] FIGS. 15A-C show schematic views of a plunger release mechanism in three different states, [0091] FIGS. 16A-C show schematic views of a button release mechanism in three different states, [0092] FIG. 17 is an isometric view of an alternative embodiment of the plunger release mechanism, [0093] FIG. 18 is a longitudinal section of an alternative embodiment of the button release mechanism, [0094] FIGS. 19A-B show longitudinal sections of an alternative embodiment of the detent mechanism, [0095] FIG. 20 is a longitudinal section of a third embodiment of the detent mechanism, [0096] FIG. 21 is a longitudinal section of an alternative embodiment of the feedback release mechanism, [0097] FIGS. 22A-B show longitudinal sections of an alternative embodiment of the needle extension control mechanism, also arranged to perform the function of the detent mechanism on needle retraction and needle extension, [0098] FIG. 23 is an isometric view of the needle extension control mechanism of FIG. 22 , [0099] FIGS. 24A-B show longitudinal sections of a third embodiment of the needle extension control mechanism, also arranged to perform the functions of the detent mechanism, [0100] FIG. 25 is an isometric view of the needle extension control mechanism of FIG. 24 , [0101] FIGS. 26A-B shows longitudinal sections of a third embodiment of the feedback release mechanism, and [0102] FIGS. 27A-B is another embodiment of the auto-injector having a wrap-over sleeve trigger instead of a trigger button. [0103] Corresponding parts are marked with the same reference symbols in all figures. DETAILED DESCRIPTION [0104] A ramped engagement in the terminology of this specification is an engagement between two components with at least one of them having a ramp for engaging the other component in such a manner that one of the components is flexed aside when the components are axially pushed against each other provided this component is not prevented from flexing aside. [0105] FIGS. 1 a and 1 b show two longitudinal sections of an auto-injector 1 in different section planes, the different section planes approximately 90° rotated to each other, wherein the auto-injector 1 is in an initial state prior to starting an injection. The auto-injector 1 comprises a chassis 2 . In the following the chassis 2 is generally considered as being fixed in position so motion of other components is described relative to the chassis 2 . A syringe 3 , e.g. a Hypak syringe, with a hollow injection needle 4 is arranged in a proximal part of the auto-injector 1 . When the auto-injector 1 or the syringe 3 is assembled a protective needle sheath 5 is attached to the needle 4 . A stopper 6 is arranged for sealing the syringe 3 distally and for displacing a liquid medicament M through the hollow needle 4 . The syringe 3 is held in a tubular carrier 7 and supported at its proximal end therein. The carrier 7 is slidably arranged in the chassis 2 . [0106] A drive spring 8 in the shape of a compression spring is arranged in a distal part of the carrier 7 . A plunger 9 serves for forwarding the force of the drive spring 8 to the stopper 6 . [0107] The drive spring 8 is loaded between a distal carrier end face 10 of the carrier 7 and a thrust face 11 arranged distally on the plunger 9 . [0108] The carrier 7 is a key element housing the syringe 3 , the drive spring 8 and the plunger 9 , which are the components required to expel the medicament M from the syringe 3 . These components can therefore be referred to as a drive sub-assembly. [0109] The chassis 2 and the carrier 7 are arranged within a tubular case 12 . A trigger button 13 is arranged at a distal end of the case 12 . In a plunger release mechanism 27 a peg 14 protrudes from a distal end face of the trigger button 13 in the proximal direction P between two resilient arms 15 originating from the distal carrier end face 10 thus preventing them from flexing towards each other in an initial state A illustrated in FIG. 15A . In FIG. 15A only one of the resilient arms 15 is shown to illustrate the principle. Outwardly the resilient arms 15 are caught in respective first recesses 16 in a distal plunger sleeve 17 attached distally to the thrust face 11 and arranged inside the drive spring 8 . The engagement of the resilient arms 15 in the first recesses 16 prevents axial translation of the plunger 9 relative to the carrier 7 . The resilient arms 15 are ramped in a manner to flex them inwards on relative motion between the plunger 9 and the carrier 7 under load of the drive spring 8 , which is prevented by the peg 14 in the initial state A. [0110] The carrier 7 is locked to the chassis 2 for preventing relative translation by a detent mechanism 18 illustrated in more detail in FIGS. 11A to 11D . [0111] The trigger button 13 is initially engaged to the case 12 by a button release mechanism 26 and cannot be depressed. The button release mechanism 26 is illustrated in detail in FIGS. 16A to 16C . Referring now to FIG. 16A the button release mechanism 26 comprises a resilient proximal beam 13 . 1 on the trigger button 13 , the proximal beam 13 . 1 having an outward first ramp 13 . 2 and an inward second ramp 13 . 3 . In an initial state A illustrated in FIG. 16A the outward first ramp 13 . 2 is engaged in a ramped first case detent 12 . 1 preventing the trigger button 13 from moving out of the distal end D. The trigger button 13 proximally abuts both the case 12 and the carrier 7 hence being prevented from being depressed in the proximal direction P. [0112] Referring again to FIGS. 1A and 1B a control spring 19 in the shape of another compression spring is arranged around the carrier 7 and acts between a proximal first collar 20 and a distal second collar 21 . The control spring 19 is used to move the carrier 7 and hence the drive sub-assembly in the proximal direction P for needle extension or in the distal direction D for needle retraction. [0113] In the state as delivered as shown in FIGS. 1 a and 1 b a cap 22 is attached to the proximal end of the case 12 and the protective needle sheath 5 is still in place over the needle 4 and the needle hub. An inner sleeve 22 . 1 of the cap 22 is arranged inside the chassis 2 and over the protective needle sheath 5 . In the inner sleeve 22 . 1 a barb 23 is attached. The barb 23 is engaged to the protective needle sheath 5 for joint axial translation. [0114] A sequence of operation of the auto-injector 1 is as follows: [0115] A user pulls the cap 22 from the proximal end of the case 12 . The barb 23 joins the protective needle sheath 5 to the cap 22 . Hence, the protective needle sheath 5 is also removed on removal of the cap 22 . FIGS. 2 a and 2 b show the auto-injector 1 with the cap 22 and needle sheath 5 removed. The carrier 7 and syringe 3 are prevented from moving in the proximal direction P by the detent mechanism 18 being in a state A as in FIG. 11A . Referring now to FIG. 11A , the detent mechanism 18 comprises a resilient beam 2 . 1 on the chassis 2 with an inwardly protruding first beam head 2 . 2 . The first beam head 2 . 2 has a proximal third ramp 2 . 3 . The detent mechanism 18 further comprises a rhomboid ramp member 7 . 1 on the carrier 7 having a proximal fourth ramp 7 . 2 and a distal fifth ramp 7 . 3 . In state A a rounded off distal side of the first beam head 2 . 2 abuts the ramp member 7 . 1 in the distal direction D resisting movement of the carrier 7 in the proximal direction P relative to the chassis 2 . A rib on the case 12 is provided for preventing outward deflection of the resilient beam 2 . 1 thereby also preventing motion of the carrier 7 relative to the chassis 2 . [0116] Referring again to FIGS. 2A and 2B the user grabs the case 12 and places the chassis 2 protruding from the case 12 at the proximal end P against an injection site, e.g. a patient's skin. As the auto-injector 1 is pressed against the injection site the case 12 translates in the proximal direction P relative to the chassis 2 into an advanced position as illustrated in FIGS. 3A and 3B . The second collar 21 is locked to the case 12 and is moved with the case 12 relative to the chassis 2 and relative to nearly all other components of the auto-injector 1 thus slightly compressing the control spring 19 against the first collar 20 which is prevented from moving in the proximal direction P by the chassis 2 due to a needle extension control mechanism 24 being in a state A illustrated in detail in FIG. 12A . Referring now to FIG. 12A , a resilient member in the shape of an arrowhead 20 . 1 is proximally arranged on the first collar 20 . The first collar 20 with the arrowhead 20 . 1 is being forced in the proximal direction P under load of the compressed control spring 19 . An outward sixth ramp 20 . 2 on the arrowhead 20 . 1 interacts with a second distal seventh ramp 2 . 4 on the chassis 2 ramping the arrowhead 20 . 1 in an inward direction I which is prevented by the arrowhead 20 . 1 inwardly abutting the carrier 7 . Hence, the first collar 20 cannot translate in the proximal direction P. [0117] Referring again to FIGS. 3A and 3B the second collar 21 is locked to the case due to a syringe retraction control mechanism 25 being in a state A illustrated in detail in FIG. 13A . Referring now to FIG. 13A , the syringe retraction control mechanism 25 comprises a resilient proximal beam 21 . 1 on the second collar 21 , the proximal beam 21 . 1 having a second beam head 21 . 2 having an inward boss 21 . 3 and a distal outward eighth ramp 21 . 4 . The distal outward eighth ramp 21 . 4 is engaged in a ramped second case detent 12 . 2 in a manner ramping the second beam head 21 . 1 in the inward direction I with the second collar 21 under load of the control spring 19 in the distal direction D which is prevented by the inward boss 21 . 3 inwardly abutting the carrier 7 . [0118] Referring again to FIGS. 3A and 3B , if the user was to move the case 12 away from the injection site, the control spring 19 expands returning the auto-injector 1 to the initial condition after removal of the cap 22 as illustrated in FIGS. 2A and 2B . [0119] In the state as in FIGS. 3A and 3B the carrier 7 continues to be prevented from moving in the proximal direction P by the detent mechanism 18 , however with the case 12 in its advanced position the detent mechanism 18 is unlocked as the rib on the case 12 has also moved and no longer prevents outward deflection of the resilient beam 2 . 1 . Movement of the case 12 relative to the carrier 7 , which is locked to the chassis 2 by the detent mechanism 18 , causes the button release mechanism 26 to switch to a state B illustrated in FIG. 16B . The trigger button 13 cannot translate with the case 12 in the proximal direction P as it is abutted against the carrier 7 . The ramp on the first case detent 12 . 1 interacts with the outward first ramp 13 . 2 on the proximal beam 13 . 1 on the trigger button 13 deflecting the proximal beam 13 . 1 in the inward direction I thus engaging the inward second ramp 13 . 3 on the proximal beam 13 . 1 in a ramped carrier detent 7 . 4 arranged in the carrier 7 . As the case 12 is translated further in the proximal direction P it supports the proximal beam 13 . 1 outwardly thus locking the trigger button 13 to the carrier 7 . The trigger button 13 now protrudes from the distal end D of the chassis 12 and is ready to be pressed. [0120] In the state as in FIGS. 3A and 3B the user depresses the trigger button 13 in the proximal direction P. As the trigger button 13 abuts against the carrier 7 the carrier 7 is pushing in the proximal direction P against the chassis 2 , the carrier 7 and the chassis 2 interacting in the detent mechanism 18 . The force exerted by the user pressing the trigger button 13 is resolved through the chassis 2 onto the injection site, not between the trigger button 13 and the case 12 . The detent mechanism 18 provides a resistive force when the user pushes the trigger button 13 . Once the user applies a force which exceeds a pre-determined value the detent mechanism 18 releases, initiating the injection cycle. Referring now to FIG. 11B showing the detent mechanism 18 in a state B, the resilient beam 2 . 1 on the chassis 2 begins to bow under load from the rhomboid ramp member 7 . 1 on the carrier 7 , storing elastic energy. Despite the proximal fourth ramp 7 . 2 on the ramp member 7 . 1 friction between the contacting faces of the first beam head 2 . 2 and the proximal fourth ramp 7 . 2 prevents movement of the first beam head 2 . 2 in the outward direction O until the straightening force in the resiliently deformed beam 2 . 1 is sufficiently large to overcome it. At this point the resilient beam 2 . 1 is deflected in the outward direction O moving out of the way of the carrier 7 thus allowing the carrier 7 to translate in the proximal direction P. When the carrier 7 travels sufficiently far in the proximal direction P the rhomboid ramp member 7 . 1 on the carrier 7 passes under the first beam head 2 . 2 thus allowing it to relax and move back in the inward direction I distally behind the rhomboid ramp member 7 . 1 in a state C illustrated in FIG. 11C at the same time constraining translation of the carrier 7 in the distal direction D relative to the chassis 2 . [0121] Once the carrier 7 slides far enough in the proximal direction P relative to the first collar 20 the needle extension control mechanism 24 is switched to a state B as illustrated in FIG. 12B . In FIG. 12B the carrier 7 has been translated in the proximal direction P in such a manner that the arrowhead 20 . 1 on the first collar 20 is no longer inwardly supported. This may be achieved by a second recess 7 . 5 in the carrier 7 . The arrowhead 20 . 1 is now deflected in the inward direction I into the second recess 7 . 5 under load of the control spring 19 arriving at a state C as illustrated in FIG. 12C . The first collar 20 is now decoupled from the chassis 2 . Instead, the arrowhead 20 . 1 couples the first collar 20 to the carrier 7 by an inward ninth ramp 20 . 3 engaging a distal tenth ramp 7 . 6 on the carrier 7 at the proximal end of the second recess 7 . 5 . Hence, the control spring 19 continues moving the carrier 7 in the proximal direction P from this point. Whilst the user advances the needle 4 by a proportion of its travel, the control spring 19 takes over insertion before the needle 4 protrudes from the proximal end P. Therefore the user experience is that of pressing a button, rather than manually inserting a needle. [0122] The detent mechanism 18 relies on the user applying a force rather than a displacement. Once the force applied exceeds the force required to switch the detent the user will push the trigger button 13 fully, ensuring that the first collar 20 will always switch. If the user fails to pass the detent, the trigger button 13 returns to its unused state ready for use as illustrated in FIGS. 3A and 3B . This feature avoids the auto-injector 1 arriving in an undefined state. [0123] FIGS. 4A and 4B show the auto-injector 1 with the trigger button 13 depressed sufficiently for the control spring 19 to couple on to the carrier 7 and continue moving the carrier 7 forwards, but not yet abutting the case 12 . [0124] The carrier 7 coupled to the first collar 20 is translated in the proximal direction P driven by the control spring 19 . As the syringe 3 is arranged for joint axial translation with the carrier 3 the syringe 3 and needle 4 are also translated resulting in the needle 4 protruding from the proximal end P and being inserted into the injection site. The trigger button 13 returns to its initial position relative to the case 12 and latches back to the case 12 from the carrier 7 as in state A in FIG. 16 A. The carrier 7 translates further in the proximal direction P preventing inward deflection of the proximal beam 13 . 1 so the outward first ramp 13 . 2 cannot disengage from the first case detent 12 . 1 . [0125] Immediately prior to the needle 4 reaching full insertion depth as illustrated in FIGS. 5A and 5B the peg 14 on the trigger button 13 is completely pulled out from between the resilient arms 15 on the carrier 7 . Hence, the plunger release mechanism 27 arrives in a state B shown in FIG. 15B with the resilient arms 15 no longer inwardly supported by the peg 14 . Due to the ramped engagement of the resilient arms 15 in the first recess 16 they are deflected in the inward direction I under load of the drive spring 8 arriving in a state B illustrated in FIG. 15C . Hence, the plunger 9 is released from the carrier 7 and driven in the proximal direction P by the drive spring 8 , ready to expel the medicament M. The force to pull the peg 14 out from between the resilient arms 15 is provided by the control spring 19 while the force required to deflect the resilient arms 15 out of engagement to the plunger 9 is provided by the drive spring 8 . [0126] While the plunger 9 moves and closes a gap to the stopper 6 the movement of the carrier 7 in the proximal direction P is completed by the control spring 19 pushing the first collar 20 . As the carrier 7 moves with respect to the chassis 2 during needle extension the needle extension mechanism 24 arrives in a state D illustrated in FIG. 12D . The arrowhead 20 . 1 has moved with the carrier 7 and is still kept inwardly deflected by the chassis 2 thus preventing the first collar 20 from disengaging the carrier 7 . The arrowhead 20 . 1 must be able to deflect in the outward direction O to allow retraction which will be discussed below. In order to allow outward deflection the arrowhead 20 . 1 travels proximally beyond the part of the chassis 2 shown in FIGS. 12A to 12F next to an aperture 2 . 5 in the chassis 2 . However, as long as the case 12 is being kept pressed against the injection site and not allowed to return in the distal direction D beyond a predefined distance under load of the control spring 19 the arrowhead 20 . 1 will be kept from deflecting in the outward direction O by a first rib 12 . 3 on the case 12 (not illustrated in FIGS. 12A to F, see FIGS. 5A to 8A ) during about the second half of its motion for needle extension. [0127] The needle 4 is now fully inserted into the injection site as illustrated in FIGS. 6A and 6B . The time between the trigger button 13 pressed and the needle 4 being fully inserted is very short, however several mechanical operations take place in this time. The needle extension depth is defined by the carrier 7 relative to the chassis 2 not relative to the case 12 , so if the user flinches or fails to hold the auto-injector 1 hard against the skin, only the case 12 will move in the distal direction D while the injection depth remains constant. [0128] As soon as the plunger 9 has closed the gap to the stopper 6 under force of the drive spring 8 the stopper 6 is pushed in the proximal direction P within the syringe 3 displacing the medicament M through the needle 4 . [0129] Immediately prior to the end of expelling the medicament with the stopper 6 having almost bottomed out in the syringe 3 as illustrated in FIGS. 7A and 7B a feedback component 28 is released. The stack up of tolerances, most notably due to the syringe 3 requires that the feedback must always be released prior to fully expelling the medicament. Otherwise, with certain combinations of parts, the feedback would not always release. The feedback component 28 comprises an elongate portion 28 . 1 arranged within the distal plunger sleeve 17 and a distal end plate 28 . 2 arranged between the carrier end face 10 and an end face of the trigger button 13 . Two second resilient arms 30 originate from the distal carrier end face 10 and extend in the proximal direction P. A feedback spring 29 is arranged to bias the feedback component 28 in the distal direction D relative to the carrier 7 by proximally bearing against a rib on the second resilient arms 30 and distally against the feedback component 28 (not illustrated). [0130] Note: the feedback component 28 is not illustrated in FIGS. 16A , B and C for clarity since it does not affect the function of the button release mechanism 26 . A feedback release mechanism 31 for releasing the feedback component 28 is schematically illustrated in FIGS. 14A, 14B and 14C . Referring now to FIG. 14A , the feedback release mechanism 31 comprises the second resilient arms 30 . A ramped inward boss 30 . 1 is arranged on each second resilient arm 30 which is engaged to a respective outward eleventh ramp 28 . 3 on the elongate portion 28 . 1 of the feedback component 28 in such a manner that the second resilient arm 30 is deflected in the outward direction O under load of the feedback spring 29 . In an initial state A of the feedback release mechanism 31 the second resilient arms 30 are prevented from being outwardly deflected by outward support of the distal plunger sleeve 17 thus preventing translation of the feedback component 28 relative to the carrier 7 . The feedback release mechanism 31 remains in state A until immediately prior to fully expelling the medicament with the stopper 6 having almost bottomed out in the syringe 3 as illustrated in FIGS. 7A and 7B . At this point the plunger 9 has been translated in the proximal direction P relative to the carrier 7 to such an extent that the second resilient arms 30 are no longer supported by the distal plunger sleeve 17 . The feedback release mechanism 31 has thus arrived in a state B illustrated in FIG. 14B . Due to the ramped engagement between the ramped inward boss 30 . 1 and the outward eleventh ramp 28 . 3 the second resilient arm 30 is outwardly deflected under load of the feedback spring 29 thus disengaging the feedback component 28 from the carrier 7 and allowing the feedback component 28 to move in the distal direction D driven by the feedback spring 29 in a state C illustrated in FIG. 14C . Hence, the feedback component 28 is accelerated in the distal direction D and the distal end plate 28 . 2 impacts on the inside of the trigger button 13 producing audible and tactile feedback to the user that expelling the medicament is about finished. [0131] FIGS. 8A and 8B show the auto-injector 1 with the stopper 6 having entirely bottomed out in the syringe 3 . [0132] As mentioned above the user is able to let the case 12 move by a few millimetres in the distal direction D under the force of the control spring 19 without affecting the position of the needle 4 as long as that motion is below a predefined distance. If the user wishes to end the injection, at any time, they must allow the case 12 to move in the distal direction D beyond that distance. FIGS. 9A and 9B show the auto-injector 1 with the chassis extended, e.g. when lifted from the injection site with the case 12 moved all the way in the distal direction D so that the chassis 2 protrudes from the proximal end of the case 12 . As the case 12 is moved the first collar 20 releases the carrier 7 and then the second collar 21 releases from the case 12 and pulls the carrier 7 in the distal direction D. The sequencing of this switching is critical as retraction will fail if both collars 20 , 21 are attached to the carrier 7 at the same time. This is overcome by separating the switching of the collars 20 , 21 by a significant displacement of the case 12 . [0133] The switching of the first collar 20 is illustrated in FIGS. 12E and F. In FIG. 12E the case 12 has been allowed to move in the distal direction D under load of the control spring 19 , e.g. during removal of the auto-injector 1 from the injection site. The first rib 12 . 3 (not illustrated, see FIG. 9A ) is removed from outwardly behind the arrowhead 20 . 1 . The first collar 20 is still being pushed in the proximal direction P by the control spring 19 . Due to the engagement of the inward ninth ramp 20 . 3 on the arrowhead 20 . 1 with the distal tenth ramp 7 . 6 on the carrier 7 the arrowhead 20 . 1 is deflected in the outward direction O into the aperture 2 . 5 of the chassis 2 (illustrated in FIGS. 12A to 12F ), the needle extension control mechanism 24 arriving in a state E as illustrated in FIG. 12E , decoupling the first collar 20 from the carrier 7 and latching it to the chassis 2 . [0134] As the case 12 is moving further in the distal direction D relative to the chassis, e.g. on removal from the injection site, the syringe retraction control mechanism 25 switches from its state A (cf. FIG. 13A ) into a state B illustrated in FIG. 13B . The case 12 and the second collar 21 locked to the case 12 move together in the distal direction D while the carrier 7 is held in place by the detent mechanism 18 in its state C as described above (cf. FIG. 11C ). Due to this motion the inward boss 21 . 3 on the second beam head 21 . 2 of the proximal beam 21 . 1 on the second collar 21 no longer inwardly abuts the carrier 7 . Instead the inward boss 21 . 3 is deflected in the inward direction I into a third recess 7 . 7 in the carrier 7 due to the ramped engagement of the second beam head 21 . 1 to the ramped second case detent 12 . 2 under load of the control spring 19 . The syringe retraction control mechanism 25 thus arrives in a state C as illustrated in FIG. 13C with the second collar 21 decoupled from the case 12 and coupled to the carrier 7 . The detent mechanism 18 applies a small retarding force to the movement of the carrier 7 before the syringe retraction control mechanism 25 switches to state C as there is a small sliding force, applied by the second collar 21 , pulling the carrier 7 in the distal direction D on translation of the case 12 in the distal direction D when the needle extension control mechanism 24 has already been switched into state E. If the carrier 7 moves too far in the distal direction D before the second collar 21 switches, the case 12 runs out of travel before the inward boss 21 . 3 can deflect into the third recess 7 . 7 preventing retraction. [0135] Starting from the position C of the detent mechanism 18 (cf. FIG. 11C ) the carrier 7 and hence the rhomboid ramp member 7 . 1 are translated in the distal direction D under load of the control spring 19 . Hence, the distal fifth ramp 7 . 3 of the rhomboid ramp member 7 . 1 engages the proximal third ramp 2 . 3 on the first beam head 2 . 2 of the resilient beam 2 . 1 in a manner deflecting the resilient beam 2 . 1 in the inward direction I. This applies the small retarding force to the movement of the carrier 7 required for ensuring the switching of the second collar 21 to the carrier 7 . The resilient beam 2 . 1 and the rhomboid ramp member 7 . 1 are offset sideways to allow the resilient beam 2 . 1 to pass without contacting the rhomboid ramp member 7 . 1 as soon as the first beam head 2 . 2 is entirely inwardly from the ramp member 7 . 1 in a state D illustrated in FIG. 11D . [0136] The control spring 19 is grounded at its proximal end in the case by the first collar 20 being abutted against the chassis 2 . The distal end of the control spring 19 moves the second collar 21 in the distal direction D taking with it the carrier 7 and hence the syringe 3 with the needle 4 overcoming the detent mechanism 18 as illustrated in FIG. 11D . Note that the needle 4 is retracted by the auto-injector 1 as soon as the user allows the case 12 to translate sufficiently far as opposed to auto-injectors with needle shields which require the user to remove the auto-injector from the injection site thereby themselves pulling the needle out of the skin for allowing the needle shield to advance. [0137] As the movement allowed of the feedback component 28 is limited relative to the carrier 7 it is no longer in contact with the trigger button 13 which has moved in the distal direction D with the case 12 on removal from the injection site. [0138] When the retraction begins the feedback spring 29 does not provide any retarding force. Once the feedback component 28 hits the trigger button 13 again on retraction of the carrier 7 the feedback spring 29 must be recompressed, reducing the force driving the final part of retraction. In order to ensure a reliable retraction despite this reducing force the control spring 19 must be appropriately dimensioned. [0139] The retraction ends when the distal collar 21 meets a first back stop 12 . 4 on the case 12 as in FIGS. 10A and 10B . The arrowhead 20 . 1 on the first collar 20 is inwardly supported by the carrier 7 in a state F illustrated in FIG. 12F and thus prevented from deflecting in the inward direction I. The outward sixth ramp 20 . 2 of the arrowhead 20 . 1 is engaged behind the first rib 12 . 3 on the case 12 preventing the case 12 from being pushed in the proximal direction P again. A clearance may be provided between the arrowhead 20 . 1 and the first rib 12 . 3 to allow for tolerances. [0140] The detent mechanism 18 returns to state A as in FIG. 11A locking the carrier 7 in position relative to the chassis 2 as it did initially, however it cannot be unlocked now as the case 12 cannot move relative to the chassis 2 . [0141] A tab 20 . 4 on the first collar 20 is now visible through an indicator window 32 in the case 12 —indicating the auto-injector 1 has been used. [0142] FIG. 17 is an isometric view of an alternative embodiment of the plunger release mechanism 27 . The plunger release mechanism 27 prevents movement of the plunger 9 in the proximal direction P relative to the carrier 7 until the carrier 7 is moved in the proximal direction P for needle extension. As opposed to the plunger release mechanism 27 of FIG. 15 , where relative movement of the carrier 7 and trigger button 13 are used to trigger the release of the plunger 9 , the alternative embodiment of FIG. 17 releases the plunger 9 by movement of the carrier 7 relative to the second collar 21 . FIG. 17 illustrates the plunger release mechanism 27 prior to plunger release. The second collar 21 is shown transparent to improve clarity. The plunger 9 is being pushed in the proximal direction P by the drive spring 8 . In order for the plunger 9 to advance, it must rotate around a twelfth ramp 7 . 8 on the carrier 7 . A ramp member 9 . 1 on the plunger 9 is arranged to engage this twelfth ramp 7 . 8 . Rotation of the ramp member 9 . 1 is blocked by an inward longitudinal rib 21 . 5 on the second collar 21 splined in a longitudinal aperture 7 . 9 in the carrier 7 . The case 12 and the second collar 21 remain in the same position, i.e. coupled to each other for joint axial translation. On depression of the trigger button 13 the carrier 13 and the plunger 9 being part of the drive sub-assembly are moved in the proximal direction P, first by the user pressing the trigger button 13 and then by the control spring 19 taking over via the first collar 20 as described above. Once the carrier 7 moves sufficiently far in the proximal direction P relative to the second collar 21 the ramp member 9 . 1 on the collar 9 comes clear of the longitudinal rib 21 . 5 on the second collar 21 and can rotate past the proximal end of the longitudinal rib 21 . 5 due to its ramped engagement to the twelfth ramp 7 . 8 under load of the drive spring 8 . Hence, the drive spring 8 advances the plunger 9 in the proximal direction P for expelling the medicament M. [0143] FIG. 18 is a longitudinal section of an alternative embodiment of the button release mechanism 26 . Other than the button release mechanism 26 of FIG. 16 which gives the appearance of a revealing trigger button 13 on skin contact by switching the ground of the trigger button 13 between the carrier 7 and the case 12 , the button release mechanism 26 of FIG. 18 starts with the trigger button 13 locked but protruding from the distal end of the case 12 . Once the carrier 7 has moved in the distal direction D on skin contact of the chassis 2 , it is possible to depress the trigger button 13 and activate the auto-injector 1 . This ensures a sequenced operation. [0144] In the embodiment of FIG. 18 the trigger button 13 has two proximal beams 13 . 1 , each of them having a ramped outward boss 13 . 4 . In the initial state shown in FIG. 18 the ramped outward bosses 13 . 4 are engaged in respective fourth recesses 12 . 5 in the case 12 . Disengaging the ramped outward bosses 13 . 4 from the fourth recesses 12 . 5 is prevented by the carrier 7 inwardly supporting the proximal beams 13 . 1 in a manner to keep the proximal beams 13 . 1 from deflecting inwardly. Inward protrusions 13 . 5 on the proximal beams 13 . 1 abut against a second rib 7 . 10 on the carrier 7 in a manner preventing the carrier 7 from moving further in the proximal direction P in the initial state. Once the carrier 7 has moved in the distal direction D on skin contact of the chassis 2 a first window 7 . 11 in the carrier 7 is moved behind the inward protrusion 13 . 5 so as to allow the proximal beams 13 . 1 to be inwardly deflected due to their ramped engagement in the fourth recesses 12 . 5 on depression of the trigger button 13 . The proximal beams 13 . 1 are now outwardly supported by the case 12 and remain engaged to the carrier 7 even on retraction of the needle 4 . The trigger button 13 does therefore not return to its initial position, indicating that the auto-injector 1 has been used. [0145] The button release mechanism 26 illustrated in FIG. 18 may preferably be combined with the plunger release mechanism 27 illustrated in FIG. 17 . [0146] FIGS. 19A and 19B show two longitudinal sections of an alternative embodiment of the detent mechanism 18 . The detent mechanism 18 of FIGS. 11A to 11D , which may be referred to as a “race track” mechanism because of the first beam head 2 . 2 travelling around the rhomboid ramp member 7 . 1 has multiple functions which control the movement of the carrier 7 relative to the chassis 2 . The alternative detent mechanism 18 of FIGS. 19A and 19B uses three clips 7 . 12 , 7 . 13 , 2 . 6 to produce the same effect. [0147] The first clip 7 . 12 is arranged as an outwardly biased resilient beam on the carrier 7 extending from the carrier 7 in the proximal direction P. the first clip 7 . 12 is arranged to prevent the carrier 7 from being moved in the proximal direction P prior to the chassis 2 being depressed or rather the case 12 being translated on skin contact. The first clip 7 . 12 is composed of two sections side by side. A first section 7 . 14 prevents movement of the carrier 7 in the proximal direction P by abutting the chassis 2 in a recess. A second section 7 . 15 is arranged as an outwardly protruding clip head arranged to be ramped inwards by a ramp feature 12 . 6 on the chassis 12 for releasing the first clip 7 . 12 thereby unlocking the carrier 7 from the chassis 2 when the case 12 is being translated in the proximal direction P on skin contact. A longitudinal slot 2 . 7 in the chassis 2 is arranged for allowing the second section 7 . 15 to slide in the proximal direction P once the lock has been released. A slight friction force between the first clip 7 . 12 and the chassis 2 provides the retarding force required to ensure retraction. [0148] The second clip 7 . 13 is arranged as a resilient beam on the carrier 7 extending in the distal direction D having an outwardly protruding third beam head 7 . 16 with a proximal ramp. The third beam head 7 . 16 serves as a back stop against a third rib 2 . 9 on the chassis 2 for preventing the carrier 7 moving in the distal direction D from its initial position. The carrier 7 and chassis 2 are assembled with the second clip 7 . 13 in this position prior to inserting the syringe 3 into the carrier 7 which is facilitated by the proximal ramp on the third beam head 7 . 16 . The syringe 3 locks the clip in place by preventing inward deflection thus creating a fixed stop. [0149] The third clip 2 . 6 is a resilient beam on the chassis 2 extending in the distal direction D. A ramped fourth beam head 2 . 8 on the third clip 2 . 6 is arranged to inwardly engage in a fifth recess 7 . 17 in the carrier 7 . Once the first clip 7 . 12 is unlocked, the user can load the third clip 2 . 6 by pressing the carrier 7 in the proximal direction P on depression of the trigger button 13 . The third clip 2 . 6 is loaded in compression, i.e. it will bend outwards and release suddenly due to its ramped engagement to the carrier 7 providing the detent functionality similar to that illustrated in FIG. 11B . [0150] FIG. 20 is a longitudinal section of a third embodiment of the detent mechanism 18 which is a variation on the embodiment of FIGS. 19A and 19B . In this embodiment the detent function of the third clip 2 . 6 has been added into the first clip 7 . 12 . The lock between the case 12 and the carrier 7 is released in the same way, but the detent is provided by deflecting the first clip 7 . 12 inwards a second level which is achieved by the chassis 2 not having a slot 2 . 7 for the second section 7 . 15 . Instead the second section 7 . 15 , once ramped inwards by the ramp feature 12 . 6 on the case 12 has to be further ramped inwards inside the chassis 2 on axial load between the chassis 2 and the carrier 7 , suddenly releasing their engagement. [0151] FIG. 21 is a longitudinal section of an alternative embodiment of the feedback release mechanism 31 . As opposed to the feedback release mechanism 31 of FIG. 14 where the feedback spring 29 acts between the carrier 7 and the feedback component 28 , in the embodiment illustrated in FIG. 21 the feedback spring 29 acts between the case 12 and the feedback component 28 . During needle extension the feedback spring 29 is compressed as the feedback component 28 moves with the carrier 7 relative to the case 12 . When the feedback component 28 is released by the plunger 9 shortly before the end of dose, the feedback component 28 moves in the distal direction D and impacts the trigger button 13 . Other than in FIG. 14 the feedback spring 29 is not being recompressed during needle retraction since it is grounded in the case 12 not in the carrier 7 . [0152] FIGS. 22A and 22B show longitudinal sections of an alternative embodiment of the needle extension control mechanism 24 which is also arranged to perform the detent function of the detent mechanism 18 on needle retraction and needle extension. FIG. 23 shows a corresponding isometric view. A fourth clip 20 . 5 on the first collar 20 is arranged as a resilient beam with a beam head having an inward proximal thirteenth ramp 20 . 6 for engaging a fourth rib 7 . 18 on the carrier 7 and outwardly supported by the case 12 so as to keep the first collar 20 engaged to the carrier 7 prior to use, during needle extension and during expelling the medicament. When the case 12 moves in distal direction relative to the carrier, e.g. when the user lifts the case 12 away from the injection site at the end of injection, a sixth recess 12 . 7 in the case 12 is moved outwardly behind the fourth clip 20 . 5 allowing the fourth clip 20 . 5 to release when the carrier 7 is pulled in the distal direction D by the second collar 21 . Since the fourth clip 20 . 5 has to be ramped outwards a small force is required to release the fourth clip 20 . 5 , providing the retraction detent. [0153] A fifth clip 2 . 10 on the chassis 2 abuts a block 20 . 7 on the first collar 20 prior to use preventing the first collar 20 and hence the carrier 7 engaged to the first collar 20 from moving in the proximal direction P. In order to release, the fifth clip 2 . 10 must be deflected outwards and over the block 20 . 7 . Outward deflection of the fifth clip 2 . 10 is initially prevented by the case 12 . Once the case 12 has moved on skin contact a second window 12 . 8 in the case 12 appears outwardly from the fifth clip 2 . 10 allowing outward deflection. The fifth clip 2 . 10 is then deflected by a fourteenth ramp 7 . 19 on the carrier 7 when the carrier 7 is pushed in the proximal direction P on button depression as the fourth clip 20 . 5 does allow translation of the carrier 7 in the proximal direction P relative to the first collar 20 but not the other way round. The detent for needle extension is provided by having to deflect the fifth clip 2 . 10 when it is loaded by the control spring 19 . [0154] FIGS. 24A and 24B show longitudinal sections of a third embodiment of the needle extension control mechanism 24 , also arranged to perform the functions of the detent mechanism 18 . FIG. 25 is an isometric view of the needle extension control mechanism 24 of FIG. 24 . The embodiment is similar to that illustrated in FIGS. 22A, 22B and 23 . The difference is that the fifth clip 2 . 10 is arranged on the first collar 20 and the block 20 . 7 is arranged on the chassis 2 , i.e. their position has been switched, so there are two clips 2 . 10 and 20 . 5 on the first collar 20 . [0155] The fourth clip 20 . 5 is identical to that in FIG. 22B . It keeps the first collar 20 connected to the carrier 7 until the needle retraction is triggered, ensuring full needle extension length or depth is reached and maintained until the retraction cycle is initiated by displacing the case backwards in distal direction relative to the chassis, e.g. when removing the auto-injector 1 from the skin. [0156] The fifth clip 2 . 10 provides the detent for needle extension and releases the first collar 20 from the chassis 2 , initiating needle extension. The fifth clip 2 . 10 prevents the first collar 20 and hence the carrier 7 engaged to the first collar 20 from moving in the proximal direction P prior to use by abutting the block 20 . 7 on the chassis 2 . In order to release, the fifth clip 2 . 10 must be deflected outwards and over the block 20 . 7 . Outward deflection of the fifth clip 2 . 10 is initially prevented by the case 12 . Once the case 12 has moved on skin contact the second window 12 . 8 in the case 12 appears outwardly from the fifth clip 2 . 10 allowing outward deflection. The fifth clip 2 . 10 is then deflected by the fourteenth ramp 7 . 19 on the carrier 7 when the carrier 7 is pushed in the proximal direction P on button depression as the fourth clip 20 . 5 does allow translation of the carrier 7 in the proximal direction P relative to the first collar 20 but not the other way round. The detent for needle extension is provided by having to deflect the fifth clip 2 . 10 when it is loaded by the control spring 19 . [0157] FIGS. 26A and 26B show a longitudinal section of a third embodiment of the feedback release mechanism 31 . This embodiment works without the need for a dedicated feedback spring. The plunger 9 comprises a proximally ramped rib 9 . 2 arranged to splay two seventh clips 7 . 21 on the carrier 7 immediately prior to the end of dose. When the proximally ramped rib 9 . 2 has traveled past the seventh clips 7 . 21 they snap back and impact the plunger 9 generating a sound. The tubular shape of the carrier 7 helps to transmit the sound. FIG. 26A shows the feedback release mechanism 31 before release. FIG. 26B shows the feedback release mechanism 31 after release. Proximal faces of the seventh clips 7 . 21 on the carrier 7 are axially offset to facilitate assembly by lifting the seventh clips 7 . 21 over the distal side of the proximally ramped rib 9 . 2 one by one. [0158] FIGS. 27A and 27B show longitudinal sections of another embodiment of the auto-injector 1 in different section planes, the different section planes approximately 90° rotated to each other, wherein the auto-injector 1 is in an initial state prior to use. The auto-injector 1 is essentially identical to the one described in FIGS. 1 to 16 . However, other than the auto-injector of FIGS. 1 to 16 the auto-injector 1 of this embodiment has a wrap-over sleeve trigger instead of a trigger button. [0159] The wrap-over sleeve trigger 12 is the same component as the case 12 which has a closed distal end face 12 . 10 other than the one in FIGS. 1 to 16 . An internal trigger button 13 is arranged at the distal end inside the sleeve trigger 12 . Other than in FIGS. 1 to 16 the trigger button 13 is not visible nor does it protrude from the case 12 in any state. In the initial state a clearance 33 is provided between the distal end face 12 . 10 of the sleeve trigger 12 and the internal trigger button 13 allowing for some travel of the sleeve trigger 12 without interfering with the trigger button 13 . [0160] As the auto-injector 1 does not differ from the auto-injector of FIGS. 1 to 16 in other respects it is essentially operated in the same way with the following exceptions: [0161] As the chassis 2 is placed against the injection site the sleeve trigger 12 translates in the proximal direction P relative to the chassis 2 into the advanced position in a first phase of sleeve travel removing the clearance 33 between the distal end face 12 . 10 of the sleeve trigger 12 and the internal trigger button 13 . As in the embodiment of FIGS. 1 to 16 this motion unlocks the detent mechanism 18 and the trigger button 13 . As the user continues to depress the sleeve trigger 12 in a second phase of sleeve travel thereby further advancing it in the proximal direction P the distal end face 12 . 10 hits the internal trigger button 13 thereby depressing it until the first collar 20 is released from the chassis 2 and the control spring force is coupled on to the carrier 7 . The carrier 7 then advances until the internal trigger button 13 stops on another rib in the case 12 and the plunger release mechanism 27 is released (note the peg 14 is shorter in this embodiment. [0162] From a user perspective, the detent mechanism 18 is arranged to provide a resistive force when the user reaches the second phase of sleeve travel. Internally, there is no difference to the embodiment of FIGS. 1 to 16 at this point. [0163] Needle extension is triggered by the user fully advancing the sleeve trigger 12 in the second phase of sleeve travel thereby fully depressing the internal trigger button 13 and overcoming the detent mechanism as in the embodiment of FIGS. 1 to 16 . [0164] As the control spring 19 takes over on button depression fully advancing the carrier 7 for needle extension the internal trigger button 13 bottoms out on an internal fifth rib 12 . 11 in the sleeve trigger 12 and the internal trigger button 13 switches back to being locked to the sleeve trigger 12 as in FIG. 16C . [0165] The embodiment of FIGS. 27A and 27B may also be combined with the alternative features illustrated in FIGS. 17 to 26 . [0166] It goes without saying that in all ramped engagements between two components described in the above embodiments there may be just one ramp on one or the other component or there may be ramps on both components without significantly influencing the effect of the ramped engagement.

1a

BACKGROUND OF THE INVENTION [0001] Field of Use of the Invention [0002] This invention relates to a portable bed assembly. This invention specifically relates to components for a bed assembly particularly including a headrest end support. This invention further relates to a portable assembly for a double-decker bed having a headrest end support construction. [0003] Background and Discussion of the Prior Art [0004] Portable bunk bed assemblies are disclosed in U.S. Pat. No. 7,797,772, U.S. Pat. No. 7,921,483, U.S. Pat. No. 8,356,369, and US D600,469 to Bonatz, the inventor herein, which patents are incorporated herein in their entireties by reference thereto. [0005] Bunk beds with rigid fixedly disposed end constructions are disclosed in U.S. Pat. No. 4,555,821 to Page, US Publ. 2004/0035980 to McDonnell and US Publ. 2005/0050633 to Roger. [0006] The immediately aforesaid constructions do not provide or otherwise are not suitable as headrests and protective end supports for children, and are costly to manufacture and assemble. [0007] The art desires a bunk bed headrest and protective end support that is particularly suitable for and safe for use by children, that is readily manufactured, and readily assembled and disassembled. [0008] The present invention provides a solution to these art needs. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a perspective view of the bunk beds showing the present invention; [0010] FIG. 2 is a perspective view of the lower bunk bed showing the present invention; [0011] FIG. 3 is a perspective view of the upper bunk bed showing the present invention; [0012] FIG. 4 is an end view of the lower bed frame; [0013] FIG. 5 is an end view of the upper bed frame; [0014] FIG. 6 is a plan view of one side of the mat and headrest of the present invention; [0015] FIG. 7 is a plan view of the other side of the mat and headrest as shown in FIG. 6 ; and [0016] FIG. 8 is a perspective view showing the assembly of the headrest as shown in FIGS. 6-7 , on the upper bunk end frame as show in FIG. 5 . SUMMARY OF THE INVENTION [0017] The present invention is a portable bed head end assembly, particularly for a double-decker or bunk beds. The bunk beds have a flexible cot or mat material that integrally includes a readily assembled and disassembled headrest or protective end piece. The flexible mat headrest construction protects and encloses a child when sleeping on the upper or lower bed. DESCRIPTION OF THE INVENTION [0018] The bunk bed assembly, particularly the disc and metal elongate support and frame assembly members, as shown in the FIGS., may be those as shown and described in U.S. Pat. No. 7,921,483, issued Apr. 12, 2011 and U.S. Pat. No. 8,356,369, issued Jan. 22, 2013 to Bonatz, the herein inventor, which references are incorporated herein in their entireties by reference thereto. [0019] Referring to the FIGS., there is shown the double-decker bed or bed assembly 10 of the present invention. Bed 10 includes an upper bed or cot 11 and a lower bed or cot 12 . The bed construction in general includes eight assembly discs 13 , four tubular assembly side members construction in general includes eight assembly discs 13 , four tubular assembly side members or assemblies 14 (typical), two upper bed tubular head or foot assemblies 15 , and two lower head or foot assemblies 16 , two horizontally disposed cross members or supports 17 , two vertically disposed integrating connecting straps 18 , and two canvas or like flexible material bed support pieces 22 A and 22 B. [0020] Referring to the FIGS., there is shown the lower bed or cot 12 in the single bed disposition. Bed 12 has four assembly discs 13 and two tubular foot assemblies 16 and two tubular frame assemblies 14 interconnected with flexible material or canvas bed support piece 22 A to in general from the assembled single lower bed 12 . [0021] Referring to the FIGS., there is shown upper bed or cot 11 in the single bed disposition. Bed 11 has four assembly discs 13 , two tubular assemblies 15 , two tubular frame assemblies 14 with flexible material or canvas bed support piece 22 B to in general form the assembled single upper bed 11 . [0022] In the afore-discussed construction, two essentially uniform construction carrying cases may be provided to effectively stow all the components for assembling the double-decker bed or two separate single beds. Canvas bed supports 22 A and B may also be like or separately transported or provided. The canvas bed supports may need to be periodically washed or replaced with extended use. [0023] Referring to FIGS. 1, 2, 3 and 6-8 , there is shown canvas bed support members 22 A and 228 . Bed support members 22 A and 23 B may be a one-piece construction with side portions 25 (typical) enclosed by stitching 27 (typical) for slidably receiving metal tubular supports 14 (typical). The head or foot ends of each bed support member is formed with two spaced flaps 26 (typical). Each flap has cooperatively engaging Velcro® elements 30 a and 30 b , for purposes hereinafter appearing. The spaced flaps 26 form a slot 31 (typical) for slidably accommodating vertical straps 18 ( FIGS. 1 and 8 ). The slot end portions may be contoured at 35 , as best shown in FIGS. 1 and 8 . Referring to the FIGS., there is shown Velcro® elements 30 a and 30 b disconnectably connected so as to be connected around horizontal frame member 17 . In the aforesaid manner of construction vertically disposed end portions 40 (typical) are provided at the head and foot ends of the upper and lower beds. The end portions 40 prevent a child from sliding through the frame and falling off the bed. The Velcro® elements 30 a and 30 b are disposed on the outside of the bed and may not be readily tampered with or disengaged by a child sleeping in the upper or lower bed. Vertically disposed end support 40 is curved or contoured as at 45 for headrest comfort. [0024] In the afore-described construction, a double-decker bed or two separate single beds can be readily assembled and disassembled. While the foregoing describes a construction assembly for one double-decker bed or two single beds, it is within the contemplation of the present invention to provide further expanded construction assemblies such as for a triple-decker bed. [0025] The foregoing description is intended to be merely illustrative and not limiting of the invention, which invention is defined by the adjoined claims.

1a

BACKGROUND [0001] Cardiovascular disease is one of the leading causes of death in the United States and most European countries. It is estimated that over 70 million people in the United States alone suffer from a cardiovascular disease or disorder including but not limited to high blood pressure, coronary heart disease, dislipidemia, congestive heart failure and stroke. [0002] At high doses (e.g. >1500 mg) niacin is a potent lipid lowering drug with the ability to lower very low density and low density lipoprotein particles and increase high density lipoprotein cholesterol-C (HDL-C). However, at these doses, niacin causes vascular-cutaneous flushing mediated by prostaglandin D 2 and seriously limits patient compliance and thus effectiveness. At lower doses (e.g. <1500 mg/day) niacin only increases HDL-C without lowering very low density and low density lipoprotein particles. Extended- and sustained-release forms of niacin have been developed and can reduce (but not eliminate) flushing, but can also cause liver toxicity, gastrointestinal upset, nausea, diarrhea, sexual dysfunction and fatigue. These side effects significantly limit the use of niacin therapy. SUMMARY [0003] In one embodiment, the present invention provides a pharmaceutical composition comprising nicotinic acid in an amount of not more than about 1200 mg, not more than about 1000 mg, not more than about 750 mg, or not more than about 500 mg and eicosapentaenoic acid or a derivative thereof. In one embodiment, the composition contains not more than 10%, by weight, docosahexaenoic acid, if any. In another embodiment, the eicosapentaenoic acid or derivative thereof is eicosapentaenoic acid ethyl ester. In still another embodiment, the composition contains substantially no amount of docosahexaenoic acid or derivative thereof, if any. [0004] In another embodiment, the present invention provides a method of treating and/or preventing a cardiovascular-related disease or disorder selected from primary hyperlipidemia, hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, coronary heart disease, vascular disease, stroke, atherosclerosis, arrhythmia, hypertension, myocardial infarction, and other cardiovascular events, comprising administering to a subject in need thereof 1 to a plurality of dosage units comprising a composition or compositions as disclosed herein. [0005] In still another embodiment, the invention provides a method of treating or preventing a cardiovascular-related disease or disorder in subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising (a) nicotinic acid in an amount of not more than about 1200 mg, not more than about 1000 mg, not more than about 750 mg, or not more than about 500 mg and (b) eicosapentaenoic acid or a derivative thereof; wherein the composition comprises not more than 10%, by weight, docosahexaenoic acid or derivative thereof, if any. [0006] In another embodiment, the present invention provides a method of treating or preventing a cardiovascular-related disease or disorder in a subject in need thereof, comprising: co-administering to the subject a first pharmaceutical composition comprising nicotinic acid in an amount of not more than about 1200 mg, not more than about 1000 mg, not more than about 750 mg, or not more than about 500 mg and a second pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof wherein said second pharmaceutical composition contains not more than 10%, by weight, docosahexaenoic acid or derivative thereof, if any, substantially no docosahexaenoic acid or derivative thereof, or no docosahexaenoic acid or derivative thereof. [0007] In another embodiment, the invention provides a method of one or more of: (a) decreasing serum low-density lipoprotein cholesterol (“LDL-C”), (b) decreasing serum triglyceride levels, (c) increasing serum high-density-lipoprotein cholesterol (“HDL-C”) levels, (d) reducing apolipoprotein B (“Apo B”) levels compared to baseline, and/or (e) decreasing serum non-high density lipoprotein cholesterol (“non-HDL-C”; i.e. the difference between total cholesterol and HDL-C) levels in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition or compositions comprising (a) nicotinic acid in an amount of not more than about 1500 mg, not more than about 1200 mg, not more than about 1000 mg, not more than about 750 mg, or not more than about 500 mg and (b) eicosapentaenoic acid or a derivative thereof, wherein the composition contains not more than 10%, by weight, docosahexaenoic acid or derivative thereof, if any, substantially no docosahexaenoic acid or derivative thereof, or no docosahexaenoic acid or derivative thereof. [0008] In another embodiment, the present invention provides a method of delaying or reducing the risk of cardiac arrest in a subject in need thereof, the method comprising administering to a subject in need thereof a pharmaceutical composition comprising (a) nicotinic acid in an amount of not more than about 1500 mg, not more than about 1200 mg, not more than about 1000 mg, not more than about 750 mg, or not more than about 500 mg and (b) eicosapentaenoic acid or a derivative thereof, wherein the composition contains not more than 10%, by weight, docosahexaenoic acid or derivative thereof, if any, substantially no docosahexaenoic acid or derivative thereof, or no docosahexaenoic acid or derivative thereof. [0009] In still another embodiment, the present invention provides a kit comprising a first pharmaceutical composition comprising nicotinic acid in an amount of not more than about 1500 mg, not more than about 1200 mg, not more than about 1000 mg, not more than about 750 mg, or not more than about 500 mg, and a second pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof, wherein the second pharmaceutical composition contains not more than 10%, by weight, docosahexaenoic acid, if any. [0010] In another embodiment, the invention provides a method of reducing niacin-induced flushing in a subject comprising providing a subject that is to begin niacin therapy, pre-treating the subject with EPA and administering niacin to the subject following said pre-treatment. [0011] These and other embodiments of the present invention will be disclosed in further detail herein below. BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 shows that administration of −97% pure EPA to subjects results in increased RBC EPA and decreased RBC arachidonic acid levels. DETAILED DESCRIPTION [0013] While the present invention is capable of being embodied in various forms, the description below of several embodiments is made with the understanding that the present disclosure is to be considered as an exemplification of the invention, and is not intended to limit the invention to the specific embodiments illustrated. Headings are provided for convenience only and are not to be construed to limit the invention in any manner. Embodiments illustrated under any heading may be combined with embodiments illustrated under any other heading. [0014] The use of numerical values in the various quantitative values specified in this application, unless expressly indicated otherwise, are stated as approximations as though the minimum and maximum values within the stated ranges were both preceded by the word “about.” in this manner, slight variations from a stated value can be used to achieve substantially the same results as the stated value. As used herein, the terms “about” and “approximately” when referring to a numerical value shall have their plain and ordinary meanings to one skilled in the pertinent art at issue. Also, the disclosure of ranges is intended as a continuous range including every value between the minimum and maximum values recited as well as any ranges that can be formed by such values. Also disclosed herein are any and all ratios (and ranges of any such ratios) that can be formed by dividing a recited numeric value into any other recited numeric value. Accordingly, the skilled person will appreciate that many such ratios, ranges, and ranges of ratios can be unambiguously derived from the numerical values presented herein and in all instances such ratios, ranges, and ranges of ratios represent various embodiments of the present invention. [0015] Without being held to a particular theory, it is believed that eicosapentaenoic acid is a competitive inhibitor of arachidonate metabolism in the cyclo-oxygenase pathway and that reduction of PGD 2 levels by EPA attenuates niacin flushing. In addition to attenuating niacin-induced flushing, it is also believed, without being bound by theory, that EPA can provide beneficial cardiovascular effects such as reduced platelet aggregation, vasodilation and plaque stabilization, which are independent of an in crease in HDL-C as seen at low doses of niacin. As such, in one embodiment of the invention, a combination of low dose niacin with EPA (or pre-treatment with EPA followed by low dose niacin) is provided. In another embodiment, such therapy provides effective cardiovascular benefits with reduced side effects compared to conventional niacin dosing. Eicosapentaenoic Acid [0016] In one embodiment, compositions of the invention comprise eicosapentaenoic acid or a pharmaceutically acceptable ester, derivative, conjugate or salt thereof, or mixtures of any of the foregoing, collectively referred to herein as “EPA.” The term “pharmaceutically acceptable” in the present context means that the substance in question does not produce unacceptable toxicity to the subject or interaction with other components of the composition. [0017] In one embodiment, the EPA comprises an eicosapentaenoic acid ester. In another embodiment, the EPA comprises a C 1 -C 5 alkyl ester of eicosapentaenoic acid, in another embodiment, the EPA comprises eicosapentaenoic acid ethyl ester, eicosapentaenoic acid methyl ester, eicosapentaenoic acid propyl ester, or eicosapentaenoic acid butyl ester. [0018] In another embodiment, the EPA is in the form of ethyl-EPA, lithium EPA, mono-, di- or triglyceride EPA or any other ester or salt of EPA, or the free acid form of EPA. The EPA may also be in the form of a 2-substituted derivative or other derivative which slows down its rate of oxidation but does not otherwise change its biological action to any substantial degree. [0019] In another embodiment, the EPA comprises an EPA-Fatty Acid conjugate, in one embodiment, the EPA-Fatty Acid conjugates are diesters formed between EPA, a second fatty acid or EPA, and a linker as shown in structures (I)-(II), wherein R 1 and R 2 are acyl fatty acid groups derived from EPA or another fatty acid. R 1 and R 2 may both be derived from EPA (EPA-EPA) or may be derived from EPA and a different fatty acid (EPA-Fatty Acid). R 3 is generally either hydrogen, fully hydrocarbon, or containing heteroatoms, and is preferably a C 1 -C 4 alkyl group. [0000] [0020] The linker may be any suitable diol including, for example, an alkyl diol such as 1,3-propanediol, an alkenyl diol, an alkynyl diol, an aryl diol such as 1,4-dihydroxybenzene (hydroquinone), etc., or a geminal diol, for example a C 1 -C 4 alkyl geminal diol, an alkyl geminal diol, etc. The second fatty acid may be any suitable fatty acid including for example EPA, LA, AA, ALA, STA, ETA, or DPA. Synthesis of the diester conjugate is accomplished according to methods well known in the art, including for example, using metals, metal-chlorides, or organic acids as catalysts; using fatty acid chlorides such as EPA-chloride, γ-linolenic acid chloride (GLA-chloride), dihomo-γ-linolenic acid chloride (DGLA-chloride), linoleic acid chloride (LA-chloride), arachidonic acid chloride (AA-chloride), conjugated linoleic acid chloride (cLA-chloride), ALA-chloride, STA-chloride, ETA-chloride, DPA-chloride, etc.; and the use of immobilized enzymes as catalysts. [0021] In another embodiment, a composition of the present invention includes a mixture of EPA-Fatty Acid diesters. In a related embodiment, compositions of the present invention include less than 20% EPA-DHA conjugate, less than 15% EPA-DHA conjugate, less than 10% EPA-DHA conjugate, less than 9% EPA-DHA conjugate, less than 8% EPA-DHA conjugate, less than 7% EPA-DHA conjugate, less than 6% EPA-DHA conjugate, less than 5% EPA-DHA conjugate, less than 4% EPA-DHA conjugate, less than 3% EPA-DHA conjugate, less than 2% EPA-DHA conjugate, less than 1% EPA-DHA conjugate, less than 0.5% EPA-DHA conjugate, or less than 0.1% EPA-DHA conjugate, by weight of all fatty acids present. [0022] In another embodiment, a composition of the present invention includes at least 96% EPA-EPA conjugate, at least 97% EPA-EPA conjugate, at least 98% EPA-EPA conjugate, or at least 99% EPA-EPA conjugate by weight of all fatty acids present. In another embodiment, a composition of the present invention contains not more than 10%, not more than 9%, not more than 8%, not more than 7%, not more than 6%, not more than 5%, not more than 4%, not more than 3%, not more than 2%, not more than 1%, not more than 0.6%, not more than 0.5%, not more than 0.4%, not more than 0.3%, not more than 0.2, or not more than 0.1% of any EPA-Fatty Acid conjugate other than EPA-EPA diester by weight of all fatty acids present. [0023] In another embodiment, EPA is present in a composition of the invention in an amount of about 50 mg to about 5000 mg, about 75 mg to about 2500 mg, or about 100 mg to about 1000 mg, for example about 75 mg, about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, about 300 mg, about 325 mg, about 350 mg, about 375 mg, about 400 mg, about 425 mg, about 450 mg, about 475 mg, about 500 mg, about 525 mg, about 550 mg, about 575 mg, about 600 mg, about 625 mg, about 650 mg, about 675 mg, about 700 mg, about 725 mg, about 750 mg, about 775 mg, about 800 mg, about 825 mg, about 850 mg, about 875 mg, about 900 mg, about 925 mg, about 950 mg, about 975 mg, about 1000 mg, about 1025 mg, about 1050 mg, about 1075 mg, about 1100 mg, about 1025 mg, about 1050 mg, about 1075 mg, about 1200 mg, about 1225 mg, about 1250 mg, about 1275 mg, about 1300 mg, about 1325 mg, about 1350 mg, about 1375 mg, about 1400 mg, about 1425 mg, about 1450 mg, about 1475 mg, about 1500 mg, about 1525 mg, about 1550 mg, about 1575 mg, about 1600 mg, about 1625 mg, about 1650 mg, about 1675 mg, about 1700 mg, about 1725 mg, about 1750 mg, about 1775 mg, about 1800 mg, about 1825 mg, about 1850 mg, about 1875 mg, about 1900 mg, about 1925 mg, about 1950 mg, about 1975 mg, about 2000 mg, about 2025 mg, about 2050 mg, about 2075 mg, about 2100 mg, about 2125 mg, about 2150 mg, about 2175 mg, about 2200 mg, about 2225 mg, about 2250 mg, about 2275 mg, about 2300 mg, about 2325 mg, about 2350 mg, about 2375 mg, about 2400 mg, about 2425 mg, about 2450 mg, about 2475 mg or about 2500 mg. [0024] In one embodiment, a composition of the invention contains not more than about 10%, not more than about 9%, not more than about 8%, not more than about 7%, not more than about 6%, not more than about 5%, not more than about 4%, not more than about 3%, not more than about 2%, not more than about 1%, or not more than about 0.5%, by weight, docosahexaenoic acid or derivative thereof, by weight of the total composition or of all fatty acids present. In another embodiment, a composition of the invention contains substantially no docosahexaenoic acid or derivative thereof. In still another embodiment, a composition of the invention contains no docosahexaenoic acid or derivative thereof. [0025] In another embodiment, EPA comprises at least 60%, at least 70%, at least 80%, at least 90%, at least 95%, at least 97%, at least 98%, at least 99%, or 100%, by weight of all fatty acids present in a composition. [0026] In another embodiment, a composition of the invention contains less than 10%, less than 9%, less than 8%, less than 7%, less than 6%, less than 5%, less than 4%, less than 3%, less than 2%, less than 1%, less than 0.5%, less than 0.25%, by weight of the total composition or by weight of the total fatty acid content, of any fatty acid other than EPA. Illustrative examples of a “fatty acid other than EPA” include linolenic acid (LA), arachidonic acid (AA), docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), stearadonic acid (STA), eicosatrienoic acid (ETA) and/or docosapentaenoic acid (DPA). [0027] In another embodiment, a composition of the invention has one or more of the following features: (a) eicosapentaenoic acid ethyl ester represents at least 96%, at least 97%, or at least 98%, by weight, of all fatty acids present in the composition; the composition contains not more than 4%, not more than 3%, or not more than 2%, by weight, of total fatty acids other than eicosapentaenoic acid ethyl ester; (c) the composition contains not more than 0.6%, 0.5%, or 0.4% of any individual fatty acid other than eicosapentaenoic acid ethyl ester; the composition has a refractive index (20° C.) of about 1 to about 2, about 1.2 to about 1.8 or about 1.4 to about 1.5; the composition has a specific gravity (20° C.) of about 0.8 to about 1.0, about 0.85 to about 0.95 or about 0.9 to about 0.92; contains not more than 20 ppm, 15 ppm or 10 ppm heavy metals, contains not more than 5 ppm, 4 ppm, 3 ppm, or 2 ppm arsenic, and/or has a peroxide value not more than 5, 4, 3, or 2 meq/kg. Nicotinic Acid [0028] In one embodiment, a composition of the invention comprises nicotinic acid (also referred to herein as “niacin”, “3-Pyridine carboxamide” and/or “vitamin B3”). In another embodiment, the nicotinic acid is in crystalline form. In one embodiment, the EPA and nicotinic acid are not covalently linked. [0029] In one embodiment, the nicotinic acid is present in a composition of the invention in an amount of about 5 mg to about 1200 mg, about 10 mg to about 800 mg, about 15 mg to about 750 mg, about 20 mg to about 500 mg, about 25 mg to about 400 mg, or about 50 mg to about 200 mg, for example in an amount of about 25 mg, about 50 mg, 75 mg, about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, about 300 mg, about 325 mg, about 350 mg, about 375 mg, about 400 mg, about 425 mg, about 450 mg, about 475 mg, about 500 mg, about 525 mg, about 550 mg, about 575 mg, about 600 mg, about 625 mg, about 650 mg, about 675 mg, about 700 mg, about 725 mg, about 750 mg, about 775 mg, about 800 mg, about 825 mg, about 850 mg, about 875 mg, about 900 mg, about 925 mg, about 950 mg, about 975 mg, about 1000 mg, about 1025 mg, about 1050 mg, about 1075 mg, about 1100 mg, about 1125 mg, about 1150 mg, about 1175 mg, or about 1200 mg. [0030] In various embodiments, the nicotinic acid can be in immediate-release, extended-release or sustained-release form. The term “immediate-release” in the present context refers to nicotinic acid formulations from which nicotinic acid, upon ingestion by a human subject, is absorbed at a rate of about 400 to about 600 mg/hr, for example about 500 mg/hr. Typically, immediate-release nicotinic acid is not coated with any release-modifying barrier or layer. The immediate-release nicotinic acid can be in crystalline form. Niacor® (Upsher-Smith Laboratories) is an illustrative immediate-release nicotinic acid formulation. The term “extended-release nicotinic acid” herein refers to nicotinic acid formulations from which nicotinic acid, upon ingestion by a human subject, is absorbed at a rate of about 80 to about 200 mg/hr, for example about 100 mg/hr. Niaspan® (Kos Pharmaceuticals) is an illustrative extended-release nicotinic acid formulation. The term “sustained-release” in the present context refers to nicotinic acid formulations from which the nicotinic acid, when ingested by a human subject, is absorbed at a rate of about 25 mg/hr to about 75 mg/hr, for example about 50 mg/hr. [0031] In one embodiment, nicotinic acid and EPA are present in a composition of the invention, or are co-administered in a weight ratio of about 1:1000 to about 1000:1, about 1:500 to about 500:1, about 1:100 to about 100:1, about 1:50 to about 50:1, about 1:25 to about 25:1, about 1:10 to about 10:1, about 1:5 to about 5:1, about 1:4 to about 4:1 about 1:3 to about 3:1, about 1:2 to about 2:1 or about 1:1. [0032] In another embodiment, an additional cardiovascular agent is co-formulated with EPA and/or nicotinic acid, or is co-administered with EPA and/or nicotinic acid. The additional cardiovascular agent can illustratively include a 3-hydroxy-3-methyl glutaryl coenzyme A (HMG-CoA) reductase inhibitor (also referred to as a “statin”), a fibrate, or a bile salt sequesterant or binding resin. [0033] In one embodiment, a composition of the invention comprises EPA and a statin. Non-limiting examples of suitable statins that can be used in accordance with various embodiments of the invention include prevastatin, lovastatin, simvastatin, atorvastatin, fluvastatin, pitavastatin and rosuvastatin and salts thereof. In a related embodiment, the composition contains not more than 10% DHA or derivative thereof, if any. In another related embodiment, the composition contains no DHA or derivative thereof such as ethyl-DHA. [0034] A statin, if present in a composition or compositions of the invention, can be present in an amount of about 1 to about 300 mg, about 5 mg to about 200 mg, about 10 mg to about 180 mg, about 20 mg to about 150 mg, about 30 mg about 100 mg, or about 40 mg to about 60 mg. [0035] Pravastatin (Pravachol®; manufactured by Bristol-Myers Squibb, Princeton, N.J.) is hydrophilic and is best absorbed without food. Prevastatin can be present in a composition of the invention (or co-administered therewith) in an amount of about 1 to about 80 mg, about 5 mg to 60 mg, or about 10 mg to about 40 mg. [0036] Lovastatin (Mevacor®; by Merck, Whitehouse Station, N.J.) can be present in a composition of the invention (or co-administered therewith) in an amount of about 1 mg to about 100 mg, about 5 mg to about 80 mg, or about 10 mg to about 40 mg. [0037] Simvastatin (Zocor® by Merck, Whitehouse Station, N.J.) can be present in a composition of the invention (or co-administered therewith) in an amount of about 1 mg to about 80 mg per day, about 2 mg to 60 about mg, or about 5 mg to about 40 mg. [0038] Atorvastatin (Lipitor® by Pfizer, New York, N.Y.) can be present in a composition of the invention (or co-administered therewith) in an amount of about 1 mg to about 100 mg, about 5 mg to about 80 mg, or about 10 mg to about 40 mg. [0039] Fluvastatin, (Lescol® by Novartis, New York, N.Y.) can be present in a composition of the invention (or co-administered therewith) in an amount of about 5 mg to about 160 mg, about 10 mg to about 120 mg, or about 20 mg to about 80 mg. [0040] Rosuvastatin (Crestor® by Astra Zeneca, Wilmington, Del.) The dosage of rosuvastatin, in the combined administration of concentrated omega-3 fatty acids is from 1 to 80 mg, preferably 2 to 60 mg, and more preferably from 5 to 40 mg per dosage of concentrated omega-3 fatty acids. [0041] In another embodiment, a pharmaceutical composition consisting of, or consisting essentially of, EPA, nicotinic acid (and optionally a statin and/or a fibrate) and one or more pharmaceutically acceptable excipients is provided. In another embodiment, a pharmaceutical composition containing active ingredients consisting of, or consisting essentially of, EPA and nicotinic acid niacin is provided. In another embodiment, a pharmaceutical composition containing active ingredients consisting of, or consisting essentially of, EPA, nicotinic acid and a statin is provided. Dosage Forms [0042] In one embodiment, compositions of the invention are orally deliverable. The terms “orally deliverable” or “oral administration” herein include any form of delivery of a therapeutic agent or a composition thereof to a subject wherein the agent or composition is placed in the mouth of the subject, whether or not the agent or composition is swallowed. Thus “oral administration” includes buccal and sublingual as well as esophageal administration. [0043] In some embodiments, compositions of the invention are in the form of solid dosage forms. Non-limiting examples of suitable solid dosage forms include tablets (e.g. suspension tablets, bite suspension tablets, rapid dispersion tablets, chewable tablets, melt tablets, effervescent tablets, bilayer tablets, etc), caplets, capsules (e.g. a soft or a hard gelatin capsule filled with solid and/or liquids), powder (e.g. a packaged powder, a dispensable powder or an effervescent powder), lozenges, sachets, cachets, troches, pellets, granules, microgranules, encapsulated microgranules, powder aerosol formulations, or any other solid dosage form reasonably adapted for oral administration. [0044] EPA, nicotinic acid, a statin and/or any other desired active ingredient can be co-formulated in the same dosage unit, or can be individually formulated in separate dosage units. The terms “dose unit” and “dosage unit” herein refer to a portion of a pharmaceutical composition that contains an amount of a therapeutic agent suitable for a single administration to provide a therapeutic effect. Such dosage units may be administered one to a plurality (i.e. 1 to about 10, 1 to 8, 1 to 6, 1 to 4 or 1 to 2) of times per day, or as many times as needed to elicit a therapeutic response. [0045] In one embodiment, a composition of the invention comprises nicotinic acid and/or a statin dispersed or suspended in EPA, wherein the dispersion or suspension is present in a capsule (for example gelatin or HPMC capsule), sachet, or other dosage form or carrier as described herein. In another embodiment, the dispersion or suspension is substantially uniform. In still another embodiment, where co-administration of two or more dosage units is desired, the EPA is present in a first dosage unit, for example a suspension in a capsule, and the nicotinic acid is present in second dosage unit, for example a tablet. Optionally, any desired statin can be present in a third composition. [0046] In another embodiment, composition(s) of the invention can be in the form of liquid dosage forms or dose units to be imbibed directly or they can be mixed with food or beverage prior to ingestion. Non-limiting examples of suitable liquid dosage forms include solutions, suspension, elixirs, syrups, liquid aerosol formulations, etc. Storage Stability [0047] In one embodiment, compositions of the invention, upon storage in a closed container maintained at room temperature, refrigerated (e.g. about 5 to about 5-10° C.) temperature, or frozen for a period of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 months, exhibit at least about 90%, at least about 95%, at least about 97.5%, or at least about 99% of the active ingredient(s) originally present therein. Excipients [0048] Compositions of the invention optionally comprise one or more pharmaceutically acceptable excipients. The term “pharmaceutically acceptable excipient” herein means any substance, not itself a therapeutic agent, used as a carrier or vehicle for delivery of a therapeutic agent to a subject or added to a pharmaceutical composition to improve its handling or storage properties or to permit or facilitate formation of a unit dose of the composition, and that does not produce unacceptable toxicity or interaction with other components in the composition. [0049] Compositions of the invention optionally comprise one or more pharmaceutically acceptable diluents as excipients. Suitable diluents illustratively include, either individually or in combination, lactose, including anhydrous lactose and lactose monohydrate; starches, including directly compressible starch and hydrolyzed starches (e.g., Celutab™ and Emdex™); mannitol; sorbitol; xylitol; dextrose (e.g., Cerelose™ 2000) and dextrose monohydrate; dibasic calcium phosphate dihydrate; sucrose-based diluents; confectioner's sugar; monobasic calcium sulfate monohydrate; calcium sulfate dihydrate; granular calcium lactate trihydrate; dextrates; inositol; hydrolyzed cereal solids; amylose; celluloses including microcrystalline cellulose, food grade sources of α- and amorphous cellulose (e.g., Rexcel™) and powdered cellulose; calcium carbonate; glycine; bentonite; polyvinylpyrrolidone; and the like. Such diluents, if present, constitute in total about 5% to about 99%, about 10% to about 85%, or about 20% to about 80%, of the total weight of the composition. [0050] Compositions of the invention optionally comprise one or more pharmaceutically acceptable disintegrants as excipients. Suitable disintegrants include, either individually or in combination, starches, including sodium starch glycolate (e.g., Explotab™ of PenWest) and pregelatinized corn starches (e.g., National™ 1551, National™ 1550, and Colocorn™ 1500), clays (e.g., Veegum™ HV), celluloses such as purified cellulose, microcrystalline cellulose, methylcellulose, carboxymethylcellulose and sodium carboxymethylcellulose, croscarmellose sodium (e.g., Ac-Di-Sol™ of FMC), alginates, crospovidone, and gums such as agar, guar, xanthan, locust bean, karaya, pectin and tragacanth gums. Such disintegrants, if present, typically comprise in total about 0.2% to about 30%, about 0.2% to about 10%, or about 0.2% to about 5%, of the total weight of the composition. [0051] Compositions of the invention optionally comprise one or more antioxidants. Illustrative antioxidants include sodium ascorbate and vitamin E (tocopherol). One or more antioxidants, if present, are typically present in a composition of the invention in an amount of about 0.001% to about 5%, about 0.005% to about 2.5%, or about 0.01% to about 1%, by weight. [0052] Compositions of the invention optionally comprise one or more pharmaceutically acceptable binding agents or adhesives as excipients. Such binding agents and adhesives can impart sufficient cohesion to a powder being tableted to allow for normal processing operations such as sizing, lubrication, compression and packaging, but still allow the tablet to disintegrate and the composition to be absorbed upon ingestion. Suitable binding agents and adhesives include, either individually or in combination, acacia; tragacanth; sucrose; gelatin; glucose; starches such as, but not limited to, pregelatinized starches (e.g., National™ 1511 and National™ 1500); celluloses such as, but not limited to, methylcellulose and carmellose sodium (e.g., Tylose™); alginic acid and salts of alginic acid; magnesium aluminum silicate; PEG; guar gum; polysaccharide acids; bentonites; povidone, for example povidone K-15, K-30 and K-29/32; polymethacrylates; HPMC; hydroxypropylcellulose (e.g., Klucel™); and ethylcellulose (e.g., Ethocel™). Such binding agents and/or adhesives, if present, constitute in total about 0.5% to about 25%, about 0.75% to about 15%, or about 1% to about 10%, of the total weight of the composition. [0053] Compositions of the invention optionally comprise one or more pharmaceutically acceptable wetting agents as excipients. Non-limiting examples of surfactants that can be used as wetting agents in compositions of the invention include quaternary ammonium compounds, for example benzalkonium chloride, benzethonium chloride and cetylpyridinium chloride, dioctyl sodium sulfosuccinate, polyoxyethylene alkylphenyl ethers, for example nonoxynol 9 , nonoxynol 10 , and octoxynol 9 , poloxamers (polyoxyethylene and polyoxypropylene block copolymers), polyoxyethylene fatty acid glycerides and oils, for example polyoxyethylene (8) caprylic/capric mono- and diglycerides (e.g., Labrasol™ of Gattefossé), polyoxyethylene (35) castor oil and polyoxyethylene (40) hydrogenated castor oil; polyoxyethylene alkyl ethers, for example polyoxyethylene (20) cetostearyl ether, polyoxyethylene fatty acid esters, for example polyoxyethylene (40) stearate, polyoxyethylene sorbitan esters, for example polysorbate 20 and polysorbate 80 (e.g., Tween™ 80 of ICI), propylene glycol fatty acid esters, for example propylene glycol laurate (e.g., Lauroglycol™ of Gattefossé), sodium lauryl sulfate, fatty acids and salts thereof, for example oleic acid, sodium oleate and triethanolamine oleate, glyceryl fatty acid esters, for example glyceryl monostearate, sorbitan esters, for example sorbitan monolaurate, sorbitan monooleate, sorbitan monopalmitate and sorbitan monostearate, tyloxapol, and mixtures thereof. Such wetting agents, if present, constitute in total about 0.25% to about 15%, about 0.4% to about 10%, or about 0.5% to about 5%, of the total weight of the composition. [0054] Compositions of the invention optionally comprise one or more pharmaceutically acceptable lubricants (including anti-adherents and/or glidants) as excipients. Suitable lubricants include, either individually or in combination, glyceryl behapate (e.g., Compritol™ 888); stearic acid and salts thereof, including magnesium (magnesium stearate), calcium and sodium stearates; hydrogenated vegetable oils (e.g., Sterotex™); colloidal silica; talc; waxes; boric acid; sodium benzoate; sodium acetate; sodium fumarate; sodium chloride; DL-leucine; PEG (e.g., Carbowax™ 4000 and Carbowax™ 6000); sodium oleate; sodium lauryl sulfate; and magnesium lauryl sulfate. Such lubricants, if present, constitute in total about 0.1% to about 10%, about 0.2% to about 8%, or about 0.25% to about 5%, of the total weight of the composition. [0055] Suitable anti-adherents include talc, cornstarch, DL-leucine, sodium lauryl sulfate and metallic stearates. Talc is a anti-adherent or glidant used, for example, to reduce formulation sticking to equipment surfaces and also to reduce static in the blend. Talc, if present, constitutes about 0.1% to about 10%, about 0.25% to about 5%, or about 0.5% to about 2%, of the total weight of the composition. Glidants can be used to promote powder flow of a solid formulation. Suitable glidants include colloidal silicon dioxide, starch, talc, tribasic calcium phosphate, powdered cellulose and magnesium trisilicate. [0056] Compositions of the present invention optionally comprise one or more flavoring agents, sweetening agents, and/or colorants. Flavoring agents useful in the present invention include, without limitation, acacia syrup, alitame, anise, apple, aspartame, banana, Bavarian cream, berry, black currant, butter, butter pecan, butterscotch, calcium citrate, camphor, caramel, cherry, cherry cream, chocolate, cinnamon, citrus, citrus punch, citrus cream, cocoa, coffee, cola, cool cherry, cool citrus, cyclamate, cylamate, dextrose, eucalyptus, eugenol, fructose, fruit punch, ginger, glycyrrhetinate, glycyrrhiza (licorice) syrup, grape, grapefruit, honey, isomalt, lemon, lime, lemon cream, MagnaSweet®, maltol, mannitol, maple, menthol, mint, mint cream, mixed berry, nut, orange, peanut butter, pear, peppermint, peppermint cream, Prosweet® Powder, raspberry, root beer, rum, saccharin, safrole, sorbitol, spearmint, spearmint cream, strawberry, strawberry cream, stevia, sucralose, sucrose, Swiss cream, tagatose, tangerine, thaumatin, tutti fruitti, vanilla, walnut, watermelon, wild cherry, wintergreen, xylitol, and combinations thereof, for example, anise-menthol, cherry-anise, cinnamon-orange, cherry-cinnamon, chocolate-mint, honey-lemon, lemon-lime, lemon-mint, menthol-eucalyptus, orange-cream, vanilla-mint, etc. [0057] Sweetening agents that can be used in the present invention include, for example, acesulfame potassium (acesulfame K), alitame, aspartame, cyclamate, cylamate, dextrose, isomalt, MagnaSweet®, maltitol, mannitol, neohesperidine DC, neotame, Prosweet® Powder, saccharin, sorbitol, stevia, sucralose, sucrose, tagatose, thaumatin, xylitol, and the like. [0058] Flavoring agents, sweetening agents, and/or colorants can be present in compositions of the invention in any suitable amount, for example about 0.01% to about 10%, about 0.1% to about 8%, or about 1% to about 5%, by weight. [0059] Compositions of the invention optionally comprise a suspending agent. Non-limiting illustrative examples of suitable suspending agents include silicon dioxide, bentonite, hydrated aluminum silicate (e.g. kaolin) and mixtures thereof. One or more suspending agents are optionally present in compositions of the invention in a total amount of about 0.01% to about 3.0%, about 0.1% to about 2.0%, or about 0.25% to about 1.0%, by weight [0060] The foregoing excipients can have multiple roles as is known in the art. For example, starch can serve as a filler as well as a disintegrant. The classification of excipients above is not to be construed as limiting in any manner. Excipients categorized in any manner may also operate under various different categories of excipients as will be readily appreciated by one of ordinary skill in the art. Therapeutic Methods [0061] In one embodiment, compositions of the invention are useful for treatment and/or prevention of a cardiovascular-related disease or disorder. The term “cardiovascular-related disease or disorder” herein refers to any disease or disorder of the heart or blood vessels (i.e. arteries and veins) or any symptom thereof. Non-limiting examples of a cardiovascular-related disease or disorder include hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, coronary heart disease, vascular disease, stroke, atherosclerosis, arrhythmia, hypertension, myocardial infarction, and other cardiovascular events. [0062] The term “treatment” in relation a given disease or disorder, includes, but is not limited to, inhibiting the disease or disorder, for example, arresting the development of the disease or disorder; relieving the disease or disorder, for example, causing regression of the disease or disorder; or relieving a condition caused by or resulting from the disease or disorder, for example, relieving, preventing or treating symptoms of the disease or disorder. The term “prevention” in relation to a given disease or disorder means: preventing the onset of disease development if none had occurred, preventing the disease or disorder from occurring in a subject that may be predisposed to the disorder or disease but has not yet been diagnosed as having the disorder or disease, and/or preventing further disease/disorder development if already present. [0063] In one embodiment, the present invention provides a method of blood lipid therapy comprising administering to a subject in need thereof 1 to a plurality of dosage units comprising a composition or compositions as disclosed herein. In another embodiment, the subject being treated has a baseline triglyceride level, prior to treatment with a composition of the present invention, greater than about 150 mg/dl or greater than about 175 mg/dl, for example about 200 mg/dl to about 600 mg/dl or about 200 mg/dl to about 500 mg/dl. [0064] In a related embodiment, upon treatment with a composition of the present invention, for example over a period of about 1 to about 200 weeks, about 1 to about 100 weeks, about 1 to about 80 weeks, about 1 to about 50 weeks, about 1 to about 40 weeks, about 1 to about 20 weeks, about 1 to about 15 weeks, about 1 to about 10 weeks, about 1 to about 5 weeks, about 1 to about 2 weeks or about 1 week, the subject or subjects exhibit one or more of: (a) reduced triglyceride levels compared to baseline, (b) reduced Apo B levels compared to baseline, (c) increased HDL-C levels compared to baseline, (d) no increase in LDL-C levels compared to baseline, (e) a reduction in LDL-C levels compared to baseline, (f) a reduction in non-HDL-C levels compared to baseline, and/or (g) no flushing or reduced flushing compared to: (i) treatment with more than 1 g per day of nicotinic acid, (ii) treatment with more than 3 g per day of nicotinic acid, or (iii) treatment with a combination of about 1 to about 3 g per day of nicotinic acid plus about 4 g of Omacor®. Each Omacor® capsule contains 900 mg of the ethyl ester of omega-3 fatty acids—approximately 465 mg EPA and 375 mg DHA—and 4 mg α-tocopherol. [0065] Relevant serum total cholesterol, HDL-C, non-HDL-C, and LDL-C levels can be measured in accordance with any of the well known analytical methods available in the art, for example using a Synchron 4CX® 4CE to perform a blood panel analysis. In one embodiment, subjects fast for up to 12 hours prior to blood sample collection. [0066] In another embodiment, upon treatment with a composition of the present invention, the subject or subjects exhibit one or more of (a) a reduction in triglyceride level of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% as compared to baseline; (b) a reduction in non-HDL-C levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% as compared to baseline; (c) an increase in HDL-C levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% as compared to baseline; (d) a reduction in LDL-C levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% as compared to baseline; (e) a reduction in Apo B levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% as compared to baseline; and/or (f) no flushing or reduced flushing compared to: treatment with 1 g or more per day of nicotinic acid or 3 g or more per day of nicotinic acid, or a combination of about 1 to about 3 g per day of nicotinic acid plus Omacor®, for example about 4 g per day of Omacor®. [0067] In another embodiment, the present invention provides a method of treating or preventing primary hypercholesteremia and/or mixed dyslipidemia (Fredrickson Types IIa and IIb) in a subject in need thereof, comprising administering to the subject one or more compositions as disclosed herein. In a related embodiment, the present invention provides a method of reducing triglyceride levels in a subject or subjects when treatment with a statin or nicotinic acid extended-release monotherapy is considered inadequate (Frederickson type IV hyperlipidemia). [0068] In another embodiment, the present invention provides a method of treating or preventing risk of recurrent nonfatal myocardial infarction in a subject with a history of myocardial infarction, comprising administering to the subject one or more compositions as disclosed herein. [0069] In another embodiment, the present invention provides a method of slowing progression of or promoting regression of atherosclerotic disease in a subject in need thereof, comprising administering to a subject in need thereof one or more compositions as disclosed herein. [0070] In another embodiment, the present invention provides a method of treating or preventing very high serum triglyceride levels (e.g. Types IV and V hyperlipidemia) in a subject in need thereof, comprising administering to the subject one or more compositions as disclosed herein. [0071] In another embodiment, the present invention provides a method of treating subjects having very high serum triglyceride levels (e.g. greater than 1000 mg/dl or greater than 2000 mg/dl) and that are at risk of developing pancreatitis, comprising administering to the subject one or more compositions as disclosed herein. [0072] In another embodiment optionally associated with any of the methods disclosed herein, administration of any composition or compositions disclosed herein to a subject results in an absence of flushing or reduced flushing by comparison with administration of conventional high dose (e.g. >1.5 g, for example about 2 g to about 3 g maintenance dose) immediate-release, extended-release or sustained-release nicotinic acid therapy or combination therapy. The term “flushing” herein includes facial flushing or flushing associated with any other area of the skin, for example redness, itching, burning and/or tingling sensations that typically occur on the face, neck, chest, and back. [0073] In another embodiment, administration of a composition of the invention to a subject or plurality of subjects results in no flushing, tolerable flushing or decreased flushing by comparison with: (a) 3 g or more per day of nicotinic acid therapy, (b) 2 g or more per day of nicotinic acid therapy, (c) 1 g or more per day of nicotinic acid therapy, (d) at least 2 g, 3 g or 4 g of Omacor® per day plus greater than 1 g per day of nicotinic acid therapy, or (e) at least 2 g, 3 g or 4 g Omacor® per day plus 2 g or more per day of nicotinic acid therapy or 3 g or more per day of nicotinic acid therapy. [0074] In another embodiment optionally associated with any of the methods disclosed herein, administration of any of the compositions of the invention to a subject or plurality of subjects results in substantially no or no liver toxicity or reduced liver toxicity compared to administration of extended-release or sustained-release nicotinic acid dosage units to a subject or plurality of subjects in an amount of more than 1.5 g per day or greater, for example 2 g per day or greater, or 3 g per day or greater. [0075] In still another embodiment, administration of any of the compositions disclosed herein to a subject results in no flushing or decreased flushing, and no increase in LDL or reduced increase in LDL by comparison with daily co-administration of four 1 g Omacor® capsules plus 3 g of immediate-release nicotinic acid. [0076] In still another embodiment, administration of any of the compositions disclosed herein to a subject results in increased subject compliance and or decreased subject withdrawal from treatment by comparison with daily administration of four 1 g Omacor® capsules plus 3 g of immediate-release nicotinic acid. In another embodiment, subject compliance (% of subjects substantially complying with the prescribed dosage regimen) is greater than 70%, greater than 80%, greater than 90%, greater than 93%, greater than 95%, or greater than 98%, for example over a period of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 days, and/or subject withdrawal or non-compliance due to flushing (% of subjects substantially not complying with the prescribed dosage regimen due to flushing effects) is less than 8%, less than 7%, less than 5% or less than 3%, for example over a period of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 days. [0077] One embodiment of the invention comprises treating or preventing a cardiovascular-related disease or disorder as defined herein by administering to a subject in need thereof about 50 mg to about 1500 mg per day of immediate-release nicotinic acid, about 50 mg to about 5 g per day of EPA, for example ethyl ester EPA containing no DHA, and/or about 10 mg to about 300 mg per day of a statin. [0078] In another embodiment, a composition of the invention is administered to a subject in an amount sufficient to provide a daily maintenance dose of nicotinic acid of about 5 mg to about 1500 mg, about 10 mg to about 1000 mg, about 20 mg to about 800 mg, about 50 mg to about 500 mg, or about 75 mg to about 450 mg, for example in a daily amount of about 25 mg, about 50 mg, 75 mg, about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, about 300 mg, about 325 mg, about 350 mg, about 375 mg, about 400 mg, about 425 mg, about 450 mg, about 475 mg, about 500 mg, about 525 mg, about 550 mg, about 575 mg, about 600 mg, about 625 mg, about 650 mg, about 675 mg, about 700 mg, about 725 mg, about 750 mg, about 775 mg, about 800 mg, about 825 mg, about 850 mg, about 875 mg, about 900 mg, about 925 mg, about 950 mg, about 975 mg, about 1000 mg, about 1025 mg, about 1050 mg, about 1075 mg, about 1100 mg, about 1125 mg, about 1150 mg, about 1175 mg, about 1200 mg, about 1225 mg, about 1250 mg, about 1275 mg, about 1300 mg, about 1325 mg, about 1350 mg, about 1375 mg, about 1400 mg, about 1425 mg, about 1450 mg, or about 1475 mg. [0079] In one embodiment, a composition of the invention is administered to a subject in an amount sufficient to provide a daily EPA dose of about 1 mg to about 10,000 mg, 25 about 5000 mg, about 50 to about 3000 mg, about 75 mg to about 2500 mg, or about 100 mg to about 1000 mg, for example about 75 mg, about 100 mg, about 125 mg, about 150 mg, about 175 mg, about 200 mg, about 225 mg, about 250 mg, about 275 mg, about 300 mg, about 325 mg, about 350 mg, about 375 mg, about 400 mg, about 425 mg, about 450 mg, about 475 mg, about 500 mg, about 525 mg, about 550 mg, about 575 mg, about 600 mg, about 625 mg, about 650 mg, about 675 mg, about 700 mg, about 725 mg, about 750 mg, about 775 mg, about 800 mg, about 825 mg, about 850 mg, about 875 mg, about 900 mg, about 925 mg, about 950 mg, about 975 mg, about 1000 mg, about 1025 mg, about 1050 mg, about 1075 mg, about 1100 mg, about 1025 mg, about 1050 mg, about 1075 mg, about 1200 mg, about 1225 mg, about 1250 mg, about 1275 mg, about 1300 mg, about 1325 mg, about 1350 mg, about 1375 mg, about 1400 mg, about 1425 mg, about 1450 mg, about 1475 mg, about 1500 mg, about 1525 mg, about 1550 mg, about 1575 mg, about 1600 mg, about 1625 mg, about 1650 mg, about 1675 mg, about 1700 mg, about 1725 mg, about 1750 mg, about 1775 mg, about 1800 mg, about 1825 mg, about 1850 mg, about 1875 mg, about 1900 mg, about 1925 mg, about 1950 mg, about 1975 mg, about 2000 mg, about 2025 mg, about 2050 mg, about 2075 mg, about 2100 mg, about 2125 mg, about 2150 mg, about 2175 mg, about 2200 mg, about 2225 mg, about 2250 mg, about 2275 mg, about 2300 mg, about 2325 mg, about 2350 mg, about 2375 mg, about 2400 mg, about 2425 mg, about 2450 mg, about 2475 mg or about 2500 mg. [0080] In another embodiment, the statin is administered to the subject in a daily amount of about 1 to about 300 mg, about 5 mg to about 200 mg, about 10 mg to about 180 mg, about 20 mg to about 150 mg, about 30 mg about 100 mg, or about 40 mg to about 60 mg. [0081] Nicotinic acid, EPA and/or a statin can be administered as a co-formulation or as individual dosage units. Where the nicotinic acid, EPA and/or a statin are co-administered as separate dosage units, each dosage unit can be administered to a subject over a time period of 24 hours, 18 hours, 12 hours, 10 hours, 8 hours, 6 hours, 4 hours, 2 hours, 1 hour, 0.5 hours, or substantially simultaneously. [0082] In another embodiment, nicotinic acid, EPA and/or a statin can be administered sequentially. For example, EPA can be administered to a subject as a sole agent during an EPA loading period. The loading period can be, for example, 1 day, 2 days, 4 days, 6 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks or 10 weeks. After any such loading period, nicotinic acid and/or statin treatment can be initiated together with EPA or in place of EPA treatment. [0083] In another embodiment, EPA is administered to a subject in the morning, for example from about 4 am to about 10 am, and low dosee nicotinic acid (i.e. less than 1500 mg is administered to the same subject in the afternoon or evening, for example from about 12 pm to about 11 pm. [0084] In a related embodiment, upon treatment in accordance with the present invention, for example over a period of about 1 to about 200 weeks, about 1 to about 100 weeks, about 1 to about 80 weeks, about 1 to about 50 weeks, about 1 to about 40 weeks, about 1 to about 20 weeks, about 1 to about 15 weeks, about 1 to about 12 weeks, about 1 to about 10 weeks, about 1 to about 5 weeks, about 1 to about 2 weeks or about 1 week, the subject or subject group exhibits one or more of the following outcomes: [0085] (a) reduced triglyceride levels compared to baseline; [0086] (b) reduced Apo B levels compared to baseline; [0087] (c) increased HDL-C levels compared to baseline; [0088] (d) no increase in LDL-C levels compared to baseline; [0089] (e) a reduction in LDL-C levels compared to baseline; [0090] (f) a reduction in non-HDL-C levels compared to baseline; [0091] (g) a reduction in vLDL levels compared to baseline; [0092] (h) an increase in apo A-I levels compared to baseline; [0093] (i) an increase in apo A-I/apo B ratio compared to baseline; [0094] (j) a reduction in lipoprotein a levels compared to baseline; [0095] (k) a reduction in LDL particle number compared to baseline; [0096] (l) a reduction in LDL size compared to baseline; [0097] (m) a reduction in remnant-like particle cholesterol compared to baseline; [0098] (n) a reduction in oxidized LDL compared to baseline; [0099] (o) a reduction in fasting plasma glucose (FPG) compared to baseline; [0100] (p) a reduction in hemoglobin A 1c (HbA 1c ) compared to baseline; [0101] (q) a reduction in homeostasis model insulin resistance compared to baseline; [0102] (r) a reduction in lipoprotein associated phospholipase A2 compared to baseline; [0103] (s) a reduction in intracellular adhesion molecule-1 compared to baseline; [0104] (t) a reduction in interleukin-2 compared to baseline; [0105] (u) a reduction in plasminogen activator inhibitor-1 compared to baseline; [0106] (v) a reduction in high sensitivity C-reactive protein (hsCRP) compared to baseline; [0107] (w) an increase in serum phospholipid EPA compared to baseline; [0108] (x) an increase in red blood cell membrane EPA compared to baseline; and/or [0109] (y) a reduction or increase in one or more of serum phospholipid and/or red blood cell content of docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), arachidonic acid (AA), palmitic acid (PA), staeridonic acid (SA) or oleic acid (OA) compared to baseline. [0110] In one embodiment, methods of the present invention comprise measuring baseline levels of one or more markers set forth in (a)-(y) above prior to dosing the subject or subject group. In another embodiment, the methods comprise administering a composition as disclosed herein to the subject after baseline levels of one or more markers set forth in (a)-(y) are determined, and subsequently taking an additional measurement of said one or more markers. [0111] In another embodiment, upon treatment with a composition of the present invention, for example over a period of about 1 to about 200 weeks, about 1 to about 100 weeks, about 1 to about 80 weeks, about 1 to about 50 weeks, about 1 to about 40 weeks, about 1 to about 20 weeks, about 1 to about 15 weeks, about 1 to about 12 weeks, about 1 to about 10 weeks, about 1 to about 5 weeks, about 1 to about 2 weeks or about 1 week, the subject or subject group exhibits any 2 or more of, any 3 or more of, any 4 or more of, any 5 or more of, any 6 or more of, any 7 or more of, any 8 or more of, any 9 or more of, any 10 or more of, any 11 or more of, any 12 or more of, any 13 or more of, any 14 or more of, any 15 or more of, any 16 or more of, any 17 or more of, any 18 or more of, any 19 or more of, any 20 or more of, any 21 or more of, any 22 or more of, any 23 or more, any 24 or more, or all 25 of outcomes (a)-(y) described immediately above. [0112] In another embodiment, upon treatment with a composition of the present invention, the subject or subject group exhibits one or more of the following outcomes: [0113] (a) a reduction in triglyceride level of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55% or at least about 75% (actual % change or median % change) as compared to baseline; [0114] (b) a less than 30% increase, less than 20% increase, less than 10% increase, less than 5% increase or no increase in non-HDL-C levels or a reduction in non-HDL-C levels of at least about 1%, at least about 3%, at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55% or at least about 75% (actual % change or median % change) as compared to baseline; [0115] (c) an increase in HDL-C levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55% or at least about 75% (actual % change or median % change) as compared to baseline; [0116] (d) a less than 30% increase, less than 20% increase, less than 10% increase, less than 5% increase or no increase in LDL-C levels or a reduction in LDL-C levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 55% or at least about 75% (actual % change or median % change) as compared to baseline; [0117] (e) a decrease in Apo B levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55% or at least about 75% (actual % change or median % change) as compared to baseline; [0118] (f) a reduction in vLDL levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0119] (g) an increase in apo A-I levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0120] (h) an increase in apo A-I/apo B ratio of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0121] (i) a reduction in lipoprotein(a) levels of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0122] (j) a reduction in mean LDL particle number of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0123] (k) an increase in mean LDL particle size of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0124] (l) a reduction in remnant-like particle cholesterol of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0125] (m) a reduction in oxidized LDL of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0126] (n) a reduction in fasting plasma glucose (FPG) of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0127] (o) a reduction in hemoglobin A 1c (HbA 1c ) of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, or at least about 50% (actual % change or median % change) compared to baseline; [0128] (p) a reduction in homeostasis model index insulin resistance of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0129] (q) a reduction in lipoprotein associated phospholipase A2 of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0130] (r) a reduction in intracellular adhesion molecule-1 of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0131] (s) a reduction in interleukin-2 of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0132] (t) a reduction in plasminogen activator inhibitor-1 of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0133] (u) a reduction in high sensitivity C-reactive protein (hsCRP) of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, or at least about 100% (actual % change or median % change) compared to baseline; [0134] (v) an increase in serum phospholipid EPA of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 100%, at least about 200% or at least about 400% (actual % change or median % change) compared to baseline; [0135] (w) an increase in serum phospholipid and/or red blood cell membrane EPA of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, r at least about 50%, at least about 100%, at least about 200%, or at least about 400% (actual % change or median % change) compared to baseline; [0136] (x) a reduction or increase in one or more of serum phospholipid and/or red blood cell DHA, DPA, AA, PA and/or OA of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55% or at least about 75% (actual % change or median % change) compared to baseline; and/or [0137] (y) a reduction in total cholesterol of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55% or at least about 75% (actual % change or median % change) compared to baseline. [0138] In one embodiment, methods of the present invention comprise measuring baseline levels of one or more markers set forth in (a)-(y) prior to dosing the subject or subject group. In another embodiment, the methods comprise administering a composition as disclosed herein to the subject after baseline levels of one or more markers set forth in (a)-(y) are determined, and subsequently taking a second measurement of the one or more markers as measured at baseline for comparison thereto. [0139] In another embodiment, upon treatment with a composition of the present invention, for example over a period of about 1 to about 200 weeks, about 1 to about 100 weeks, about 1 to about 80 weeks, about 1 to about 50 weeks, about 1 to about 40 weeks, about 1 to about 20 weeks, about 1 to about 15 weeks, about 1 to about 12 weeks, about 1 to about 10 weeks, about 1 to about 5 weeks, about 1 to about 2 weeks or about 1 week, the subject or subject group exhibits any 2 or more of, any 3 or more of, any 4 or more of, any 5 or more of, any 6 or more of, any 7 or more of, any 8 or more of, any 9 or more of, any 10 or more of, any 11 or more of, any 12 or more of, any 13 or more of, any 14 or more of, any 15 or more of, any 16 or more of, any 17 or more of, any 18 or more of, any 19 or more of, any 20 or more of, any 21 or more of, any 22 or more of, any 23 or more of, any 24 or more of, or all 26 or more of outcomes (a)-(y) described immediately above. [0140] Parameters (a)-(y) can be measured in accordance with any clinically acceptable methodology. For example, triglycerides, total cholesterol, HDL-C and fasting blood sugar can be sample from serum and analyzed using standard photometry techniques. VLDL-TG, LDL-C and VLDL-C can be calculated or determined using serum lipoprotein fractionation by preparative ultracentrifugation and subsequent quantitative analysis by refractometry or by analytic ultracentrifugal methodology. Apo A1, Apo B and hsCRP can be determined from serum using standard nephelometry techniques. Lipoprotein (a) can be determined from serum using standard turbidimetric immunoassay techniques. LDL particle number and particle size can be determined using nuclear magnetic resonance (NMR) spectrometry. Remnants lipoproteins and LDL-phospholipase A2 can be determined from EDTA plasma or serum and serum, respectively, using enzymatic immunoseparation techniques. Oxidized LDL, intercellular adhesion molecule-1 and interleukin-2 levels can be determined from serum using standard enzyme immunoassay techniques. These techniques are described in detail in standard textbooks, for example Tietz Fundamentals of Clinical Chemistry, 6 th Ed. (Burtis, Ashwood and Borter Eds.), WB Saunders Company. [0141] In one embodiment, subjects fast for up to 12 hours prior to blood sample collection, for example about 10 hours. [0142] In another embodiment, the invention provides the use of nicotinic acid, EPA and optionally a statin or fibrate in the manufacture of a medicament for treatment or prevention of a cardiovascular-related disease or disorder such as hypertriglyceridemia, hypercholesterolemia, mixed dyslipidemia, coronary heart disease, vascular disease, stroke, atherosclerosis, arrhythmia, hypertension, myocardial infarction, and other cardiovascular events. In one embodiment, the composition contains not more than 10% DHA, if any. In another embodiment, the composition contains no DHA. [0143] In another embodiment, the invention provides a pharmaceutical composition comprising nicotinic acid and EPA for the treatment and/or prevention of a cardiovascular-related disease or disorder, wherein the composition contains not more than 10% DHA, if any. In a related embodiment, the composition contains no DHA. [0144] In one embodiment, the invention provides a method of treating a cardiovascular-related disease or disorder in a subject in need thereof comprising providing the subject with EPA pre-treatment followed by one or more doses of nicotinic acid. In one embodiment, the dose of nicotinic acid is sufficient to provide the subject with not more than 3000 mg, not more than 2000 mg, not more than 1000 mg, not more than 750 mg, not more than 500 mg, or not more than 250 mg of nicotinic acid. The term “pre-treatment” in the present context means providing the subject with one or more doses of EPA about 0.1 to about 96 hours, about 1 to about 48 hours, about 2 to about 24 hours, about 3 to about 15 hours, or about 4 to about 12 hours prior to providing the subject with an initial dose of nicotinic acid as set forth herein, for example a dose of not more than 3000 mg, not more than 2000 mg, not more than 1000 mg, not more than 750 mg, not more than 500 mg, or not more than 250 mg of nicotinic acid. In a related embodiment, the subject is pre-treated with EPA in an amount of about 1 mg to about 5000 mg per day, 1 mg to about 4000 mg per day, 1 mg to about 3000 mg per day, 1 mg to about 2000 mg per day, or 1 mg to about 1000 mg per day for a period of about 1 to about 30 days, 1 to about 20 days, 1 to about 15 days, 1 to about 10 days, 1 to about 8 days, 1 to about 6 days, 1 to about 4 days or 1 to about 2 days. [0145] In another embodiment, the invention provides a method of preventing or reducing niacin-induced flushing in a subject comprising (a) providing a subject that is to begin niacin therapy, (b) pre-treating the subject with EPA and (c) administering niacin to the subject after said pre-treatment. In one embodiment, the niacin is administered at a dose of not more than 3000 mg, not more than 2000 mg, not more than 1000 mg, not more than 750 mg, not more than 500 mg, or not more than 250 mg per day. In another embodiment, the subject is pre-treated with EPA in an amount of about 1 mg to about 5000 mg per day, 1 mg to about 4000 mg per day, 1 mg to about 3000 mg per day, 1 mg to about 2000 mg per day, or 1 mg to about 1000 mg per day for a period of about 1 to about 30 days, 1 to about 20 days, 1 to about 15 days, 1 to about 10 days, 1 to about 8 days, 1 to about 6 days, 1 to about 4 days or 1 to about 2 days. [0146] In another embodiment, the invention provides a method of reducing or attenuating niacin-induced flushing in a subject on niacin therapy, comprising (a) identifying a subject on niacin therapy and that is experiencing flushing and (b) administering EPA to the subject. In one embodiment, the niacin is administered at a dose of not more than 3000 mg, not more than 2000 mg, not more than 1000 mg, not more than 750 mg, not more than 500 mg, or not more than 250 mg per day. In another embodiment, the EPA is administered to the subject in an amount of about 1 mg to about 5000 mg per day, 1 mg to about 4000 mg per day, 1 mg to about 3000 mg per day, 1 mg to about 2000 mg per day, or 1 mg to about 1000 mg per day. [0147] In other embodiments, any of the methods disclosed herein are used in treatment or prevention of a subject or subjects that consume a traditional Western diet. In one embodiment, the methods of the invention include a step of identifying a subject as a Western diet consumer or prudent diet consumer and then treating the subject if the subject is deemed to consume a Western diet. The term “Western diet” herein refers generally to a typical diet consisting of, by percentage of total calories, about 45% to about 50% carbohydrate, about 35 to about 40% fat, and about 10% to about 15% protein. A Western diet may further be characterized by relatively high intakes of red and processed meats, sweets, refined grains, and desserts, for example where half or more or 70% or more calories come from these sources. EXAMPLES [0148] The following example is for illustrative purposes and is not to be construed as limiting the invention in any manner. [0149] An analysis was performed to assess the impact of red blood cell (RBC) EPA incorporation on arachidonic acid formation. In various studies, patients were randomized, on a double-blind basis, to receive either placebo (liquid paraffin) or 0.5 1, 2 or 4 g of 97% pure ethyl-EPA/day for 12 weeks. All the doses were administered in eight identical appearing capsules. RBCs were analyzed for EPA and AA following in general the methodology of Manku et al. M. S. Manku, D. F. Horrobin, Y. S. Huang and N. Morse, Fatty acids in plasma and red cell membranes in normal humans. Lipids 18 (1983), pp. 906-908). [0150] Venous blood was collected into a tube pretreated with EDTA and centrifuged at 1500 gav for 15 min. The plasma layer and the buffy coat were separated off and the red cells washed with an equal volume of 0.9% saline. Samples were stored at −80° C. prior to analysis. On thawing, the RBCs were suspended in NaCL/H2SO4aq. (17 mmol/l NaCl, 1 mmol/l Sulfuric acid, 1.8 ml), then shaken with methanol (3 ml). Chloroform (6 ml) and C17:O internal standard were added and the sample was stirred vigorously using a vortex mixer. After centrifugation at 2000 gav for 10 min, the lower layer containing the total lipid extract was carefully removed and filtered through anhydrous sodium sulphate before evaporation to dryness. The lipids were transesterified using Sulfuric acid/methanol. The methyl esters were purified by loading onto an isohexane-washed silica column prior to elution with isohexane:diethyl ether (95:5). The resulting methyl esters of the fatty acids were separated and measured using a Hewlett-Packard HP5890 Series II Plus Gas chromatograph (cp-wax 52CB 25m capillary column, Chrompack UK). The carrier gas was hydrogen (1 ml/min). The oven temperature was programmed to rise from 1701 to 2201° C. at 41° C./min. The detector temperature was 300° C. and injector temperature 230° C. Retention times and peak areas were automatically computed by Hewlett-Packard HP 3365 Chem. Station. [0151] As shown in FIG. 1 , increasing RBC EPA incorporation results in decreasing arachidonic acid formation. The figure below is a average for all data collected from several clinical studies.

1a

TECHNICAL FIELD OF THE INVENTION The present invention pertains in general to games and, more particularly, to a collection of gaming boards having a playing piece that can be propelled through a goal above the surface of the playing board. BACKGROUND OF THE INVENTION Gaming boards have generally been well known in the art. Most gaming boards utilize some type of flat surface and playing pieces. Typically, there are a set of rules utilized in conjunction with the playing surface to manipulate the gaming pieces thereon. Some gaming boards are considered to be passive, with a set of cards or the such. Those utilizing the gaming pieces can be considered interactive; that is, the players move the gaming pieces in response to throwing dice or rotating a pointer. Still yet further interactive gaming boards utilize a playing piece that can be propelled through the air in a third dimension above the surface of the board. These have been well known as "finger football" games, which have been played by children for a number of years. However, to date, no successful gaming board has been developed utilizing the third dimension above the surface of the board. SUMMARY OF THE INVENTION The present invention disclosed and claimed herein comprises a gaming board system. The gaming board system includes a plurality of gaming boards and a box for containing the gaming boards. A plurality of playing tokens are provided that include at least one game piece. The game piece is a triangular member having three sides with one side being longer than the other two remaining sides. The playing piece is operable to be supported on one corner in an upright position with the one longer side facing a player. The player can then impart a force to the lower end thereto relative to the supported corner to propel the playing piece forward and off the supporting surface. At least one of the gaming boards includes a flat surface, a playing pattern disposed on the flat surface with goal lines disposed at opposite ends of the pattern. The goals include uprights disposed above the surface of the playing area and disposed apart a pre-determined distance. A horizontal bar is disposed between the lower ends thereof and above the playing surface. A collapsible net is disposed on either end of the playing surface and is operable to be pulled upward behind the goals when the playing piece is propelled thereat. Inclined sides are provided along the flat surface at an angle such that they extend upward from the playing surface to contain the playing piece in the playing area. BRIEF DESCRIPTION OF THE DRAWINGS For a more complete understanding of the present invention and the advantages thereof, reference is now made to the following description taken in conjunction with the accompanying Drawings in which: FIG. 1 illustrates an exploded view of the collection of gaming boards; FIGS. 2a and 2b illustrate the way in which the major playing piece is propelled during the game; FIGS. 3a, 3b and 3c illustrate the various goals; FIG. 4 illustrates a perspective view of the gaming board utilized for football and a generic game; FIG. 5 illustrates the gaming board utilized for baseball; FIG. 6 illustrates the gaming board utilized for basketball; FIG. 7 illustrates the gaming board utilized for hockey; and FIG. 8 illustrates the gaming board utilized for soccer. DETAILED DESCRIPTION OF THE INVENTION Referring now to FIG. 1, there is illustrated an exploded view of the gaming board system of the present invention, illustrating six different gaming boards 10-20. The gaming board 10 is utilized for hockey, the gaming board 12 is utilized for a generic game termed "woodyball", the gaming board 14 is utilized for soccer, the gaming board 16 is utilized for basketball and the gaming board 18 is utilized for football. All of the gaming boards 18-20 are dimensioned such that they fit into a box 22 or container for storing the gaming boards. In addition, the container 22 contains the playing pieces 24 and also goals 26. These are typically disposed in a storage area in the box 22. Referring now to FIGS. 2a and 2b, there are illustrated methods by which the main playing piece, the "ball" is utilized during playing of the game. In FIG. 2a, the ball is represented by a triangular playing piece 28. The playing piece 28 has three faces and is rounded on all corners, with one face 28' being the impacting face. The playing piece 28 is disposed on one corner thereof with the finger holding the other corner thereof such that the face 28' is disposed substantially perpendicular to the playing surface and facing the player. The player then impacts the lower end of the face 28' or "thumps it" with his finger. This causes the lower corner thereof along the face 28' to rotate outwards and upwards. This provides the third dimensional aspect above the surface of the playing surface on boards 18-20. This will be described in more detail hereinbelow. Referring now to FIG. 2b, there is illustrated an alternate way of utilizing the playing piece 28. In this operation, the playing piece 28 is laid on its side on the surface of the playing board. The face 28' is disposed substantially parallel to the playing surface and then the player "thumps" the face 28' on one end thereof to cause the playing piece 28 to spiral outward therefrom across the surface of the playing board but not leaving the surface of the playing board. This also will be described in more detail hereinbelow. Referring now to FIGS. 3a-3c, there are illustrated various types of goals that are utilized for the playing of the game of the present invention. In FIG. 3a, a goal is illustrated for use in playing the basketball game on playing board 16. An upright 30 is provided for being disposed substantially perpendicular to the playing surface. A hoop 32 is disposed on the upper end of the upright 30, which hoop is substantially circumferential in shape and is disposed perpendicular to the playing surface. A net 34 is disposed around the peripheral edges of the hoop 32 and extends outward therefrom. The net 34 is typically made from a relatively rigid material such that it does not collapse of its own weight. Referring now to FIG. 3b, there is illustrated the goal utilized for the generic "woodyball" game board 12 and also football game board 18. The goal is comprised of an upright 36 that is disposed perpendicular to the playing surface, and a horizontal bar 38 that is disposed on the distal end of the upright 36 and centered thereon. On either end of the horizontal bar 38 are disposed uprights 40 and 42, extending upward from the most distal ends of the horizontal bar 38 and substantially parallel to the upright 36. As will be described hereinbelow, it is the object of the game to propel the playing piece 28 from a place on the playing surface through the two uprights 40 and 42 and above the horizontal bar 38. Referring now to FIG. 3c, there is illustrated a perspective view of the goal utilized for the soccer game board 14 and the hockey game board 10. The goal is generally comprised of two side portions 44 and 46 that support a rear portion 48. The rear portion 48 has a horizontal bar 50 that is disposed above and parallel to the playing surface. The rear portion 48 extends downward from the horizontal bar 50 to the playing surface at an angle thereto. The side portions 44 and 46 support the rear portion 48 to provide an opening in one side thereof. The opening allows the playing piece 28 to be propelled therein on the surface of the playing board. Referring now to FIG. 4, there is illustrated a perspective view of the playing surface for the gaming boards 12 and 18, utilized for the generic "woodyball" game and the football game. The gaming board is generally comprised of a flat surface 52 upon which a pattern 54 is disposed. There are two ends 56 and 58 to the rectangular shaped flat surface 52. The goals, comprised of the goals in FIG. 3b, are disposed on either side of the printed pattern 54 and anchored thereto. These are referred to by reference numerals 60 and 62 at ends 58 and 56, respectively. Along each side of the flat surface 52 are disposed deflector panels 64 and 66. The deflector panels 64 and 66 run along the sides of the flat surface 52 between ends 58 and 56 and angle upward. These are utilized to prevent the playing pieces from falling off of the board, or in general containing them within the playing surface. In addition, a collapsible net 68 is disposed on the end 58 and a collapsible net 70 is disposed on the end 56. The collapsible nets 68 and 70 are operable to be pulled to a substantially perpendicular orientation with respect to the playing surface 52 by the player. This is done when the opposite player is attempting to propel the game piece 24 through the goal at the other player's end. In the diagram of FIG. 4, the net 68 is pulled upward in a perpendicular configuration such that the playing piece can be propelled through the uprights on the goal 60. Net 68 allows some method for preventing the playing piece 28 from being propelled off of the playing surface 52. When not utilized, the net 68 can be collapsed such that the other player can have access to the gaming board. The net 70 is illustrated in this collapsed position. The gaming board in FIG. 4 is utilized to play the generic "woodyball" game and the football game. In the "woodyball" game, the object of the game is to be the first to collect twenty "woody points" by either a "touchdown goal" or a "woody goal". A "touchdown goal" receives two woody points and a "woody goal" receives one woody point. A touchdown is obtained by propelling the playing piece 28 across the surface of the playing board and causing it to stop on the edge of the printed pattern 54. This will provide a score of two points. A goal is obtained by propelling the playing piece 28 through the uprights of either one of the goals 60 or 62 at the opponent's end of the playing surface. This provides a score of one point. After a touchdown has been made, an extra point attempt is provided for. To begin play in the generic "woodyball" game, the player to start first is determined by a coin toss. The first player would then place the playing piece 28 on the pattern 54 at a predetermined point along the playing surface. These are typically divided up into segments of ten increments, each increment representing yards on the playing surface. Therefore, there will be graduations marked for the ten yard, twenty yard, etc., to a middle point of fifty yards from each end of the pattern 54. Initially, the playing piece 28 is disposed on the twenty yard line nearest to the player. The playing piece 28 is then propelled along the surface of the gaming board. If the playing piece 28 stops short of the end of the printed pattern 54, referred to as the goal line, then the player has the option of attempting to again propel the playing piece 28 along the surface to touch the goal line or attempt to propel the playing piece vertically through the uprights of the goal. This then results in alternation of players with each player attempting to be the first to obtain a total of twenty points. After a successful "touchdown" wherein the playing piece has been disposed on the goal line, the player can gain another point by propelling the playing piece 28 through the uprights from the thirty yard line nearest the goal. In the football gaming board 18, the pattern 54 has a plurality of game tokens shaped similar to the playing piece 28 but smaller. The graduations in the playing surface 54 are divided up into a plurality of boxes, with each box having various worded statements or the such denoted therein. These worded statements correspond to various penalties and plays in the game of football, which is conventional. For example, one box on the twenty yard line has the statement, "Complete pass, advance one space", which indicates that when the playing piece is disposed on that space, that the token can be advanced by one space. Each space therefore provides some indication of a play or a penalty in the game of football. The object of the game is to move the game token from start to finish, collecting points. Points are collected when players land on a space marked for "woody goal", and in completing a field goal with their playing piece 28 from a designated yard line on the playing field. The player begins the game on his side of the lower left hand corner at a start block. The player then rolls a pair of dice (not shown) and moves the number of spaces shown on the dice, moving up one column and down the next adjacent column and will continue until he has traversed all columns to the end. The worded spaces provide the actions which the player can take until he has finally stopped on a space. The next player then takes his turn. This continues until four lengths of the field have been completed for a total of "four quarters". During traversing of the worded spaces, certain spaces will indicate that an individual can propel the playing piece 28 through the goal from that point. This will collect a point if the playing piece 28 successfully passes between the uprights on the goal. Referring now to FIG. 5, there is illustrated a perspective view of the playing surface for the baseball gaming board 20. The baseball gaming board 20 is generally shaped like a baseball diamond and it is triangular shaped having an apex 72 that extends outward on two sides 74 and 76 with the ends of the sides 74 and 76 being connected with an arc 78. The arc 78 represents the outfield of the gaming board. A wall 80 is provided along the arc 78 and extends up from the surface of the playing board 20. Four flags 82 are disposed on the wall 80 to define uprights and provide three "regions" corresponding to "right" field, "left" field and "center" field. A pattern is disposed on the surface of the playing board 20 illustrative of the baseball playing field. The object of the game is to advance as many tokens around the playing field from first base to home base before utilizing a player's supply of special tokens defined as "out tokens". The playing field has a number of worded circles at first base, second base, third base, right field, left field and center field. These worded circles indicate the types of actions that are to be taken. Each of the worded circles has worded actions disposed therein. Initially, each player receives a playing piece 28, nine "out tokens" and ten playing tokens. The dice are rolled to determine which player starts and then the first player places a playing token on the home base portion of the playing field. The dice are then rolled to determine where the play will start, i.e., which of the worded circles that the play will start in. For example, the dice may indicate that play is to start in right field. At the right field circle, the dice are again rolled to determine the play itself. For example, if a value of "1" were rolled with the dice, this would indicate a "fly out" action. The first number therefor represents a playing area or worded circle, each worded circle having a number, and the second number rolled with the dice represents the play denoted in that circle. The token at home base is then placed at the appropriate base. If a player lands on a home run, he is then instructed by the wording in the appropriate circle at which fence, right field, left field or center field, to propel the playing piece 28. These are indicated by the flags 82, which comprise the uprights. The playing piece 28 is then disposed at the home plate, proximate to the apex 72 and then "thumped" or propelled toward the wall 80 between the appropriate flags 82. If complete, the playing tokens are then advanced around the bases toward home plate. Scoring is as in a conventional baseball game. A playing token can only be forced from its space by an advancing token. For example, if a player has a token on third base and a two base hit was rolled, the player will move the token from home base to second base, but the token at third base stays until forced to move by another two-base or three-base hit or by a home run. When a player lands at an out space, he must remove all playing tokens from the bases and give up one out token. This will end the inning for that player. He then records the number of runs scored onto a score pad. The next player will take his turn in the same manner. If when rolling the dice, a double number is rolled, a circle at the pitcher's mound indicates a number of plays. For example, whenever two "2"s are rolled, this indicates that a hit to left field has been made, and the playing token advances two bases. The play continues until all players have utilized their out tokens. Referring now to FIG. 6, there is illustrated a perspective view of the gaming board 16 utilized for basketball. The board comprises a flat surface 84, having a printed pattern 86 disposed on the upper surface thereof representing a basketball court. Goals 88 and 90 are disposed at opposite ends of the pattern 86, the goals 88 and 90 represented by the goal of FIG. 3a. The pattern 86 has two basketball "keys" at either end thereof and a half-court line 92 disposed in the center thereof. There is a central worded circle in the center of the half-court line 92 and there are three worded circles that are identical images of the other on either side of the half-court line 92. The object of the game is to accrue the most points when a player has successfully moved all playing tokens to the opposite side of the playing board. Points are collected by landing on designated spaces and successfully completing a goal into the goals 88 or 90, i.e., "thumping" the playing piece 28 into the respective one of the goals 88 or 90. The players start at the central circle at the half-court line 92 and then roll the dice to move from the central circle. If a "1" or a "6" is rolled, the token can be moved from the central circuit into the top of the key on the respective one of the goals 88 and 90 to attempt a "free throw". If a "1" was rolled, the player gets one free shot at the goal and if a "6" was rolled, the player gets two free shots at the goal. If the player is sent back to the central circle on line 92, only a "1" or a "6" showing on the dice will allow them to move. At the beginning of play, the playing tokens are placed inside the large circles, the large circles having six smaller circles disposed therein, and one token is placed in the central circuit at the half-court line 92. Each player has ten tokens. The players move toward opposite ends of the court by rolling the dice. The player first rolls a "1" or a "6" to advance to the top of the key at the respective goals 88 or 90. Once a player is out of the central circle at the half-court line 92, both the dice are rolled and one number is chosen for a large circle. Each large circle is then provided with two numbers and then one number is chosen for the small circle within the larger circle. The worded instructions in the small circle are then followed. However, if all spaces are occupied by a token, the player loses a turn. Play is continued by acting on the wording in the space to determine whether a shot is taken or whether two shots are taken at the appropriate goal with the playing piece 28 until all playing tokens have moved to the opposite sides of the game board's center line. In certain instances, the instructions result in the playing tokens being moved back to the central circle on the half-court line 92. The object is to land on as many of the small circles in the large circles that indicate a "shot" is to be taken at the appropriate one of the goals 88 or 90. The number of points accrued determines the winner of the game. Referring now to FIG. 7, there is illustrated a perspective view of the gaming board 14 for soccer. The board is configured of a flat surface 94 having a pattern 96 disposed thereon, representing a soccer field. This pattern has disposed on either side thereof penalty and player boxes 98. The goals 100 and 102 are disposed on respective ends of the pattern 96, the goals represented in FIG. 3c. The object of the game is to be the first player to collect ten points by successfully completing a goal from a designated shot space. A center line 104 has a start position circle disposed in the center thereof. Play is begun by providing a player with ten tokens disposed in the respective one of the player's boxes 98. One of these tokens is moved by each player to the start position. In the start position, the player rolls the dice and advances the player token to a numbered space corresponding to the roll. Each of the circles has a number disposed therein designating which one of the circles the playing token is advanced to. The defending player then rolls the dice to determine a goal position. The goal position is a point at which the player disposes their playing piece 28 at the defending goal. A "1" or a "2" represents the left side of the goal. A "3" or a "4" represents the center of the goal. A "5" or a "6" represents the right side of the goal. The playing piece 28 for the defending goal is disposed at the appropriate position on the goal. The player shooting will then propel his playing piece 28 along the surface of the playing board from the appropriate one of the circles. If the shot is complete and goes into the respective one of the goals 100 or 102, this represents one point. If the shot was missed, then the token must be placed in the penalty box. To remove the tokens from this box, the players must return one point for each token they want to remove and place back in the player's box. Referring now to FIG. 8, there is illustrated a perspective view of the gaming board 10 for hockey. The gaming board 10 is comprised of a flat surface 110 having a printed surface 112 thereon. The printed surface 112 has a center line 114 divided into three sections on either side thereof. Each of the three sections has a plurality of worded circles disposed therein. In addition, there are player and penalty boxes 116 disposed on either side thereof for each player. Goals 118 and 120 are disposed on either side of the printed pattern 112, goals 118 and 120 being similar to goals 100 and 102. The object of the game is to advance the playing tokens from one end of the playing field to the opposite end of the field and collecting points by landing on designated goal shot circles and completing a goal. On each side of the center line 114 there are three zones, a first attacking zone proximate to the goal, a second attacking zone midway between the goal and the center line 114 and a neutral zone proximate to the center line 114. Play is begun by placing a token on a circle that is disposed on either side of the center line 114 and central relative thereto. When a player rolls a "1" or a "6", this provides movement from the start position to move to a "free shot" zone which is directly in front of the goal. The opponent then rolls the dice to determine the goalie's position as described above with respect to FIG. 7. A shot is then taken by propelling the game piece 28 across the surface of the board into the respective one of the goals 118 and 120. If missed, play is continued. After the playing token has been advanced from the initial starting point, the tokens are advanced to the opposite end of the field, acting only on the spaces beyond the center line 114. While advancing tokens, only one token at a time can be advanced and only one zone at a time can be advanced to. In summary, there has been provided a gaming board having a plurality of boards for use with different games. Each of the gaming boards utilizes a flat surface having a printed pattern thereon. Goals provided at either end of a playing piece are utilized to both advance through various numbered spaces and also to allow propelling of the playing piece into a goal or receptacle at either end of the playing board. Although the preferred embodiment has been described in detail, it should be understood that various changes, substitutions and alterations can be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

1a

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of U.S. Provisional Application No. 62/160,295, filed May 12, 2015, which is hereby incorporated by reference. FIELD OF THE INVENTION [0002] This invention relates to mattress covers and particularly to a fabric mattress cover with an opening sufficient to receive a mattress and a zipper closure for said opening, where the zipper closure includes a buckle lock, preferably a quick release lock, for ensuring that the zipper remains closed. In one embodiment, the fabric and the zipper of said mattress cover are intended to bar travel of bed bugs through the cover or any space between the zipper into or out of the mattress or from feeding or biting through the mattress cover. Although generally described in the context of a mattress cover, the invention is applicable to any covering or encasement intended to prevent entry of bed bugs into or escape by bed bugs therefrom through a fastened closure. BACKGROUND OF THE INVENTION AND PRIOR ART [0003] Mattress covers are generally known for basic protection of mattresses, and to provide a removable and cleanable encasement when soiled. As it became known that bed bugs may reside and multiply within mattresses, and come out and bite and feed off humans while they are sleeping or bite or feed through the cover, mattress covers have been developed which are intended to prevent egress or ingress of bed bugs through the mattress cover. [0004] Bed bugs may reside not only in mattresses but in upholstery of furniture and are found in homes, theaters, luggage and vehicles, and have been carried in the clothing of people who have gotten them from any of many possible sources. [0005] Mattress covers designed to protect against bed bugs are of great interest lately because of a recent epidemic in the United States, Europe and elsewhere of bed bugs not only in mattresses but in offices and even in seats in a large movie theater in New York City. The epidemic is so severe and widespread that, for example, New York State recently passed a law designated The Bed bug Disclosure Act which requires owners and lessors of residential space to notify new rental tenants of any bed bug infestations that have occurred in the building and in the specific rental unit during the past year, where a tenant is contemplating residence. [0006] An article in The New York Law Journal dated Sep. 2, 2010 shows that complaints of bed bug infestations in New York were more than twenty times as high in 2009 as they were in 2004, the source of this information being the New York City Department of Housing, Preservation and Development. [0007] There are a number of reasons for this epidemic, including (a) the massive amount of international travel where bed bugs are imported unwittingly by persons or in luggage, and (b) current statutes barring certain insecticides which previously tended to keep the bed bug population under control. There may be additional reasons regarding the sources of this massive infestation of bed bugs or explanations for how they are transported from place to place; however, the focus of the present invention concerns first, efforts to contain bed bugs that are already in mattresses, mattress platforms and box springs, cushions, pillows, and covers and encasements therefore, and thus to prevent bed bugs from escaping to feed on humans sleeping or sitting on such articles, and second, to prevent bed bugs from entering such articles and encasements. As will be appreciated, the benefits of this invention may be utilized also for upholstered furniture and other products. Since fabrics resistant to bed bug penetration are known, the area of concern of this invention is escape of bed bugs or entry of bed bugs through the closure devices such as due to an incomplete zipper closure or a failure to properly position the zipper lockdown tab of a zipper closure. [0008] The prior art includes numerous conventional mattress covers with zipper closures intending to address this problem, one particular example being prior art patent U.S. Pat. No. 7,552,489 disclosing a mattress cover with an inner bed bug barrier strip that is situated below the zipper tracks, extends a short distance in the proximal direction from the closed end of the zipper toward the open end, and is sewn to the cover along parallel paths outward of the zipper tracks to form a tunnel below the tracks, intended to block or isolate bed bugs. [0009] In another prior art mattress cover the zipper tracks of the zipper closure section extend beyond the mattress cover encasement, and the extending zipper track portion folds back on itself with Velcro® (hook and loop) type fastening. OBJECTS AND SUMMARY OF THE NEW INVENTION [0010] In recognizing the great potential for discomfort, inconvenience, expense and danger from bed bugs exiting mattresses while persons sleep on such mattresses or attack humans with their feeding tubes extended through a mattress cover into human skin, a principal object of the present invention is to provide a mattress cover whose zipper closure blocks bed bugs from exiting a mattress and also blocks bed bugs from entering a mattress, and thus blocks these bed bugs from biting and feeding on persons sleeping on such mattresses. It is presumed that the fabric of the mattress cover will be bed bug-proof against bed bugs biting or feeding through the fabric or passing through the fabric. [0011] A further object is to provide a mattress cover with a buckle closure for ensuring that the zipper remains closed. The buckle closure includes a first part that is attached to the mattress cover and a second part that is attached to the zipper pull, also known as a zipper tab. The second part can be attached at any location of the zipper pull, including the zipper pull loop. Alternatively, the second part can be attached directly to the zipper in place of the zipper pull, so that a separate zipper pull is not used. [0012] A further object is to provide a mattress cover with an external barrier flap having an adhesive surface that can be folded down to overlie the end portion of the closed zipper, and adhere tightly onto attachment strips fixed to the cover adjacent the closure ends of the zipper tracks and the zipper pull. This structure is designed to block egress of any bed bugs that have traveled past and outward of the zipper in the area of the closed zipper pull. [0013] A still further object is to provide a more bed bug-proof mode of closure by the zipper tab at the closure end of the zipper tracks. A preferred embodiment of the present invention employs an external barrier flap having an adhesive surface that folds down onto the zipper tab in its closed position at the closure end of the zipper tracks, this flap then holding the tab in its locked down state which bars it from moving away from its closed position. The flap also serves as a visual confirmation that the tab is closed and locked down. Also the flap's adhesive surface is moldable onto the tab and the zipper tracks and into grooves adjacent said tracks to further block any possible avenues of egress of bed bugs. A still further function of the adhesive surface is to capture any bed bugs that come in contact with it. Thus, the fold-down adhesive flap can provide a plurality of different combinations of sealing functions against egress of bed bugs from within or entry of bed bugs into a mattress cover or other encasements. [0014] Another object is to provide a mattress cover as described above, where the external barrier flap has its adhesive surface covered by a peel-off protective sheet to prevent the adhesive surface from inconveniently adhering to parts of the cover or to other things it may contact prior to the time when the zipper is closed and ready for sealing with the flap. [0015] An additional object is to form the above-described attachment strips of a vinyl plastic with a smooth external surface to which the adhesive surface of said external barrier strip will readily, tightly and releasably adhere. [0016] Another object is to provide a mattress cover as described above with an external barrier flap that is attached distally or downstream of the zipper closure before it is folded down to seal atop the closure ends of the zipper tracks and the zipper pull. In this embodiment, the external barrier flap can be positioned so that the end of the zipper track is positioned (i) near the midpoint of the length of the flap or (ii) near either end of flap or (ii) anywhere else relative to the flap that is suitable to provide the intended results as discussed herein. [0017] An additional object is to provide an external barrier flap that is attached laterally of said zipper closure area and folded down transversely across the ends of the zipper tracks and the zipper pull in its closed state. In this embodiment, the external barrier flap can be positioned so that the end of the zipper track is positioned (i) near the midpoint of the length of the flap or (ii) near either end of flap or (ii) anywhere else relative to the flap that is suitable to provide the intended results as discussed herein. [0018] A still additional object is to provide an external barrier strip as described in any of the objects above where adhering material is on one or both of (a) said inner surface of said external barrier flap, or (b) said outer surfaces of said attachment strips, with a protective peel-off strip removably secured onto each of said adhering surfaces. [0019] A further object is to provide a mattress cover as described above with an internal barrier strip in addition to said external barrier flap, the internal strip fixed to said cover along one side of one zipper track and adapted to lie transversely across and beneath both tracks to serve as a further barrier or at least obstacle to egress of bed bugs from an encased mattress. [0020] An additional object is to provide in kit form a mattress cover according to any of the above-described embodiments where the external barrier flap is initially unattached to the mattress cover, but is removably attachable to the attachment strips or to cover areas adjacent the zipper tracks. The adhesive coating on the bottom or underside of the external barrier flap, besides sealing the closure area of the zipper, can provide a flypaper-like benefit for capturing any bed bugs that reach that point of egress. Also, the flap when sealed closed provides a visual affirmation that the zipper has been closed and the external seal is in place. [0021] Objects and advantages of the present invention will be further understood and appreciated by those skilled in the art by reference to the following written specification, claims and appended drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0022] FIG. 1A is a fragmentary top end perspective view of the new mattress cover with the zipper shown in a closed state, [0023] FIG. 1B is an enlarged fragmentary top end perspective view of the new mattress cover of FIG. 1A , showing the zipper in partially closed state and attachment strips exposed, [0024] FIG. 1C is similar to FIG. 1B , showing the zipper in fully closed state, with the external barrier flap in partially folded down position, [0025] FIG. 1D is similar to FIG. 1C , with the external barrier flap fully folded down and adhered to attachment strips, [0026] FIG. 2 is a fragmentary end elevation view of the mattress cover of FIGS. 1A and 1C , showing the zipper in closed state and the external barrier flap in its partially folded-down position, [0027] FIG. 3A is a fragmentary sectional elevational view taken along line 3 A- 3 A of FIG. 2 , showing said zipper closure with the external barrier flap in its partially folded-down position, [0028] FIG. 3B is similar to FIG. 3A , showing said external barrier flap sealed down onto said zipper closure, and the internal barrier strip pressed up against the underside of the zipper tracks, as it would be by an encased mattress, [0029] FIG. 4 is a fragmentary perspective view generally similar to FIG. 1C , but representing a second embodiment of the new mattress cover, and [0030] FIG. 5 is a fragmentary perspective view generally similar to FIG. 1C , but representing a third embodiment of the new mattress cover. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0031] For convenience and clarity in describing these embodiments, similar elements or components appearing in different figures will have the same reference numbers. [0032] The new mattress cover 10 shown in FIG. 1A has top wall 12 , bottom wall 13 , side walls 14 , 15 and openable end wall 16 with zipper 17 formed of zipper tracks 18 , 19 , extending along the length of end wall 16 and further extending partially around the corners 20 A, 20 B of the cover and along the side walls 14 , 15 respectively. [0033] FIGS. 1B, 1C and 1D illustrate stages of zipper closure, where FIG. 1B shows the zipper 17 closed in the area 17 A and open in the area of 17 B all the way to the end 17 C. Thus, zipper pull 21 , alternately called zipper tab, has closed area 17 A of the zipper upstream in the direction of arrow 17 D. At the open end 17 C zipper tracks 18 , 19 are slightly spaced apart. Also in FIG. 1B the external barrier flap 23 is shown in its upward partially folded-down position with its bottom adhesive coated surface 23 A covered by a protective strip 24 . FIGS. 1B and 1C show vinyl strips 26 , 27 fixed to cover 10 adjacent the end portions of zipper tracks 18 and 19 . [0034] A buckle closure is provided and has a first part 51 that is attached to the side wall 14 of the mattress cover and a second part 52 that is attached to the zipper pull 21 , whereby said first part and said second part are securely engaged by a user when said zipper is closed (see FIGS. 1C and 1D ). In the illustrated example, the first part 51 and second part 52 include the following components. The first part 51 includes a durable piece of fabric 51 A that is stitched or otherwise secured to the side wall 14 of the mattress cover. A first connection part 51 B is secured to the fabric 51 A at its free end. The first connection part 51 B includes two lateral prongs having a memory retaining quality and which spring back to their original orientation after being pressed inward. The second part 52 also includes a durable piece of fabric 52 A having a first end and a second end. The first end of the fabric 52 A is secured to the zipper pull 21 . A second connection part 52 B is secured to the second end of the fabric 52 A. The second connection part 52 B includes a cavity forming an opening at its distal end. The cavity is adapted to receive the two lateral prongs, which snap into position and lock the buckle closure together (see FIGS. 1C and 1D ). [0035] FIGS. 1C and 1D illustrate completion of the zipper closure process of FIG. 1B , showing zipper pull 21 moved into its final closure position, drawing together zipper tracks 18 , 19 . The buckle closure is shown in its locked position, where connection parts 51 B and 52 B are joined together in a snap-fit relationship. The buckle closure will remain locked until a user manually squeezes together the two lateral prongs to allow the separation of the parts. [0036] Reviewing the zipper closure stages, FIGS. 1C and 3A show exterior barrier flap 23 in its partially folded-down position, and FIGS. 1D and 3B show external barrier flap 23 in its fully folded-down and sealed position atop vinyl strips 26 , 27 and zipper tracks 18 , 19 . In this sealed or closed position adhesive surface 23 A of flap 23 tightly adheres to the outer surfaces of vinyl strips 26 , 27 and to exposed top surfaces of zipper tracks 18 , 19 , and to any exposed upper surface of zipper pull 21 , thus sealing off any opening that might have existed in the area of the terminal end zipper closure where pull 21 is positioned adjacent the terminal ends of zipper tracks 18 , 19 . [0037] FIGS. 1C and 3A further illustrate peel-off strip 24 exposing adhesive surface 23 A of barrier flap 23 . As indicated, strip 24 is peeled off flap 23 just before flap 23 is fully folded down to engage vinyl strips 26 , 27 . It would be an optional alternative to have the adhesive surface and peel-off strip on vinyl strips 26 , 27 for subsequent adherence to flap 23 instead of peel-off strip and adhesive on flap 23 . [0038] In still further variations attachment strips 26 , 27 are not required to be vinyl, but could be any material, surface or coating to which external barrier flap can be securely adhered. [0039] In a still further alternative structure the adhesive surface would be replaced with Velcro® (hook and loop) or similar engageable layers on the flap and vinyl strips respectively. [0040] FIGS. 3A and 3B illustrate a further feature and embodiment of the present invention, namely the above-disclosed structure with the further element of an internal barrier strip 40 which is an elongated strip extending the full or partial length of the zipper opening. Strip 40 has opposite side edges 41 and 42 , with only one edge sewn to the cover 10 , and accordingly the remainder of internal flap 40 can hang down freely away from the zipper closure. In FIG. 3B internal barrier strip 40 is shown horizontally as it would appear if a mattress were inside the mattress cover, and the mattress was then pushing upward as indicated by arrows 44 against the bottom of internal barrier strip 40 . Otherwise, the barrier strip 40 is free to hang as seen in dashed line representation 40 A in FIG. 3A . This strip 40 may be sewn at one or both of its ends which correspond to ends of the zipper tracks themselves. When employing both external barrier flap 20 and internal barrier strip 40 along with attachment strips 26 , 27 , all potential openings for bed bugs to exit a mattress cover are restricted, namely any path beneath and toward the zipper closure, the junction of the zipper pull with the ends of the zipper tracks, any path beyond the zipper pull. [0041] A second embodiment of the above-described invention is shown in FIG. 4 where external barrier flap 30 is secured to cover 10 on one side of zipper track 19 , and adapted to fold transversely across and seal to both attachment strips. Peel-off strip 32 exposes adhesive surface 31 . [0042] A third embodiment of the above-described invention is shown in FIG. 5 , where the external barrier flap and attachment strips described above are not utilized or required. In this embodiment the buckle closure is secured between the side wall 14 and the zipper pull 21 as described above. The buckle closure ensures that the zipper remains closed when said zipper is in its closed state to prevent penetration or passage therethrough by bed bugs. The buckle closure should be attached at an appropriate location on the side wall 14 , such that the zipper pull 21 is unable to move after the snap fit closure of the buckle is made by the user. [0043] The new mattress cover is preferably constructed of polyester knit fabric and urethane laminate that is impervious to penetration or passage therethrough by bed bugs; however other fabrics may be used if they are bed bug proof against bed bugs feeding through, biting through or traveling through the fabric. Conventional zippers may be used, so long as they too are bed bug proof. The attachments strips are preferably vinyl sheet material, but other materials are acceptable they are suitable for releasable attachable to the external barrier flap. The external barrier flap is preferably a conventional fabric tape with an adhesive material or coating on one side and a peel-off protection sheet on the adhesive side. [0044] The above-described mattress cover structures provide apparatus embodiments of the present invention, which can also be defined as a method of achieving secure releasable closure against exit of bed bugs from within a mattress cover. [0045] Such method, with a mattress cover having a zipper closed opening, comprises the steps: a. providing generally flat attachment strips on the outer surfaces of the mating zipper tracks near their closure end, b. providing an external barrier flap with a first part thereof fixed to said cover near said zipper closure end, with a main part thereof extending from said first part and situated in its open position spaced apart from said zipper closure end, where said main part has one adhesive surface covered by a peel-off protective sheet, c. closing said zipper, after inserting a mattress within said cover, by moving the zipper pull to the closure ends of said tracks, d. securing a buckle closure having a first part that is attached to the mattress cover, and a second part that is attached to the zipper pull, whereby said first part and said second part are securely engaged by a user when said zipper is closed, and e. removing said peel-off protective sheet and folding said main part adhesive surface down onto said attachment strips for sealing said zipper closure. [0051] While the invention has been described in conjunction with several embodiments, it is to be understood that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description. Accordingly, this invention is intended to embrace all such alternatives, modifications, and variations which fall within the spirit and scope of the appended claims.

1a

FIELD OF THE INVENTION The invention relates to a method and apparatus for evaluating an apparatus for measuring a diffusion capacity of a person's lungs. BACKGROUND OF THE INVENTION U.S. Pat. Nos. 5,193,551 and 6,415,642 B1 describe a method and apparatus for calibrating an apparatus for measuring a diffusion capacity of a person's lungs. Apparatuses for measuring a diffusion capacity of a person's lungs are known per se. In particular Oxygen diffusion is an important clinical measure. The rate of Oxygen diffusion from the lungs to the blood depends on diffusion capacity, and the difference between the Oxygen pressure in the blood and the alveolar space of the lungs. In clinical laboratories, lung diffusion capacity is usually measured for carbon monoxide (CO) instead of Oxygen. The reason is the very high affinity of CO for hemoglobine, which helps to keep the CO pressure in the capillary blood negligible small compared to the CO pressure in the alveolar space. Consequently, unlike the O2 diffusion capacity, the CO diffusion capacity (DLCO) can be determined non-invasively, because the pressure in the blood does not need to be measured. This is an important advantage in clinical routine. The membrane diffusion capacities DLO 2 and DLCO appear to have comparable diagnostic values. Therefore, the use of CO as a test gas for measuring diffusion capacity has become standard clinical practice. Various measurement techniques exist to measure DLCO, such as single breath, multiple breath, re-breathing and steady state methods. For many decades, the single breath (SB) technique has become the technique of choice in nearly all lung function departments and laboratories all over the word. SB machines are commercially available from several manufacturers. Good medical practice requires that these machines have to be maintained and kept in good conditions. So there is a strong need for proper devices to evaluate the machines, in an easy and uncomplicated manner (As used herein “evaluation” is any process that results in information about the operation of the DLCO measuring apparatus. Calibrating and testing are examples of “evaluating” as used herein). Typically the procedure of a DLCO measurement with a SB machine is as follows. A person connected to the SB machine is ordered first to expire maximally so that a residual volume (V 0 , initial volume) remains in the lung, then immediate afterwards to inhale maximally. At the end of the volume inhaled (VI) the patient keeps his breath during a certain breath hold time (BHT). The lung volume at breath hold time is V 0 +VI. The breath hold time can be for example 10 seconds. During the inhalation phase the SB machine provides a gas mixture containing test gas components which the patient inhales into his lungs; the test gas components are CO and an inert reference gas (inert gas, IG) like He, Ne, or CH4, both with known, pre-adjusted, concentrations. Once the patient has inhaled the gas mixture, the inertgas will be diluted by the residual volume of air mixture in the lungs that remains in the lungs all the time, while the CO, after dilution like the inert gas, and after diffusing to the bloodstream, is carried away by the bloodstream. Thus, in the lungs, the relative decrease of CO is greater then that of the inert gas IG. After the breath hold time the patient exhales, an alveolar sample of the exhaled gas is collected by the SB-machine where it is analysed for CO—and inert gas concentration. This results in the quantitative measurements of diffusion capacity using the following considerations. Quantities VI, BHT, rCO and rIG are measured. rIG is the ratio of measurements of exhalation and inhalation concentration of the inert gas IG. rCO is the ratio of measurements of those concentrations of CO. VI is the inhaled/exhaled volume and BHT is the breath hold time. The condition for diffusion in the lung can then be stated as rCO<rIG<1. During the breath hold time CO disappears through diffusion through the membrane, and as a result its concentration decreases in time. Assuming that the lung consists of one single alveolar compartment, this decrease has an exponential shape because the disappearance rate is proportional to the concentration gradient across the membrane, and this is changing continuously. DLCO is obtained from the measurement data as DLCO=− 1/( R*T )*ln( rCO/rIG )/ BHT*VI/rIG   (1) where R is the gas constant and T is absolute temperature in the lung (for example 310 K), and “ln” refers to the Naperian logarithm. Unfortunately the apparatus for measuring DLCO can malfunction, which can lead to erroneous DLCO results, for example when the determination of CO concentration, IG concentration or the volume VI suffered from errors. Therefore reliable computation of DLCO requires evaluating of the apparatus for measuring DLCO that uses the SB technique, to verify that it produces the correct results. U.S. Pat. Nos. 5,193,551 and 6,415,642 describe this type of evaluating. Both devices uses a large-volume syringe (gas cylinder with piston) to simulate the volume and volume changes of the lungs. The mouth of the syringe is connected to the mouth connection of the SB apparatus under evaluation. The volume of the internal syringe space is changed manually by a technician in the same sequence as for the SB technique (as described above), including an inhalation phase, a breath holding phase, and an exhalation phase. Both these devices intentionally modify the concentrations of inert gas and CO in the exhaled gas mixture; in such a manner that the resulting concentrations satisfy the above-mentioned conditions for CO-diffusion. U.S. Pat. No. 5,193,551 describes a calibration device using a syringe that is connected via a special purpose inter-space chamber with the SB-test machine. On some time before, a certain amount of the used inert gas is brought into the inter-space chamber. During the inhalation phase the gas mixture supplied by the machine (containing CO and inert gas) flows through the inter-space chamber into the syringe volume space, thereby taking up some of the inert gas initially present in the inter-space chamber. So, besides the volumetric dilution of the CO and inert gas, the inert gas is subjected to an additional increase. During the exhalation phase the gas in the syringe space is returned directly, without streaming through the inter-space chamber, to the evaluation machine. The resulting exhaled/inhaled concentration ratios then satisfy the condition rCO<rIG<1, signifying that CO-diffusion has validly been simulated. After analysis and subsequent calculations in the evaluation machine using a similar formula as equation (1), a DLCO-value can be predicted. A critical point of this device is the precise prediction of the fractional reduction ratios rIG and rCO. These ratios depend on the precise amount of dilution in the inter-space chamber, which in turn will depend on the particular state of gas flow and convection in the inter-space chamber (be it plug flow, ideal mixing, or some intermediate state between). However, the document supplies no information how to predict these ratios from the dilution process. Assuming that the dilution process in the inner-space chamber behaves reproducibly, the resulting simulated DLCO value will be reproducible as well, which would make this device still useful as a relative DLCO calibrator. U.S. Pat. No. 6,415,642 describes a calibration device using two syringes. The SB machine under evaluation is connected with the first syringe with which the inhalation phase is simulated. A short time before the start of the exhalation phase the other syringe is connected to the evaluation-machine. This second syringe has been filled with a test gas mixture containing CO and inert gas with precisely known concentrations that are carefully chosen so as to satisfy the condition rCO<rIG<1. In that case the SB machine can produces valid simulated DLCO values, useful for test- and calibration purposes. In both patents the obtained DLCO-value depends on several parameters: the supplied inhaled volume, the CO and inert gas concentration in the machine gas mixture as well as in the required precision test gas mixture. This makes calibration complex and sensitive to errors in these parameters. Moreover, these calibrators can only be used for testing SB-equipment. SUMMARY OF THE INVENTION Among others it is an object of the invention to provide for easier and/or more accurate evaluation of a diffusion measuring apparatus. A method and apparatus are provided according to the independent claims. A compartment is provided for receiving a gas mixture from the diffusion measuring apparatus. Gas from the compartment circulates from the compartment back to the compartment through a circulation circuit. Partial pressure of a gas species like CO is selectively reduced to a predetermined level in the circulation circuit (e.g. substantially to zero). Thus an accurate quantitative simulation of diffusion can be realized independent of other parameters by controlling the rate of flow through the circulation circuit. BRIEF DESCRIPTION OF THE DRAWINGS These and other objects and advantages will become apparent from the following description of exemplary embodiments, using the following figures. FIG. 1 schematically shows a high-end evaluation apparatus. FIG. 2 shows a low-end evaluation apparatus DETAILED DESCRIPTION OF THE INVENTION FIG. 1 schematically shows a high-end evaluation apparatus CO-TS. The CO-TS (CO-Transfer Simulator) comprises a compartment 4 coupled to a conditioning unit 13 via an input connection tube 6 and an output connection tube 7 . Conditioning unit 13 comprise a canister 1 , a sensor 12 , a pump 2 , a flow transducer 8 and a flow controller 9 . Canister 1 , sensor 12 , flow transducer 8 and pump 2 are coupled in series between input connection tube 6 and an output connection tube 7 . Canister 1 contains a material that dries the gas (if necessary) and eliminates all the CO from the gas flowing through canister 1 . The CO removing material may be Moleculite™ 403 for example and the drying material may be calcium chloride for example. In operation a gas-flow is sucked out of compartment 4 through connection tube 6 . This gas-flow is led through a canister 1 where the gas is dried (if necessary) and substantially all CO from the gas is eliminated (e.g. to less than 2% of its original partial pressure). The gas passes to CO-sensor 12 , which is optionally provided to measure concentration of CO-gas still remaining in the gas coming out of canister 1 . The sensor only functions to test the effectiveness of the material in canister 1 . When the CO-TS is functioning properly the concentration value of CO should be substantially zero. If not the material in canister 1 has lost its effectiveness after some time, this is indicated by sensor 12 , so that the material can be replaced. Pump 2 provides flow through conditioning unit 13 . This flow is measured by means of a flow transducer 8 . The measured flow is used as input for flow controller 9 . Flow controller regulates the flow of pump 2 to a pre-set value. A control input 10 may be provided to set this value by hand or by means of software in a control computer (not shown). From pump 2 , the gas is led back into the compartment 4 through output connection tube 7 . Inside compartment 4 a fan 3 is provided to ensure of a proper mixing of the gas inside compartment 4 . An embodiment is shown wherein the compartment 4 is of type of which the volume can be changed. In the example shown in the figure, the volume can be changed by means of a servo-controlled piston, but alternatively compartment 4 may be partly or completely in the form of a bellows. The use of a compartment 4 with adjustable volume simulates breathing in and breathing out. In an embodiment a control computer (not shown) is provided to control the change of volume as a function of time. A sinusoidal volume cycle may be used for example, or any other volume as a function of time. By using a computer controlled patterns of changes these patterns of changes can be repeated accurately. The change of volume (indicated by arrows 5 ) can also be performed by hand if the quality of the desired pattern is less important. Trough a port 11 the CO-TS is connected to the device under evaluation 14 . A control computer (not shown) may be configured to control the flow through the canister in relation to the value of the volume space in order to mimic the dependency of DLCO of alveolar volume. If necessary flow controller 9 can be integrated in the control computer. The apparatus of FIG. 1 simulates a CO diffusion capacity of the lung that is equal to the flow rate realized by pump 2 . The simulated DLCO equals V′/(R*T), wherein V′ is the flow rate, R is the gas constant and T is absolute temperature. With flow rates of 3-30 liters per minute DLCO's from those for babies to those of athletes can be simulated. The DLCO value can be set by setting flow rate, which makes it easy to calibrate DLCO measurements of the measurement apparatus for different DLCO values. There is no effect of inhalation and residue volumes and no reference gas supply is needed. It should be appreciated that this form of simulation enables reliable evaluation of all types of CO diffusion measurement, including not only single breath measurement, but also the known multiple breath measurements, re-breathing and steady state methods to be used on patients breathing themselves or artificially ventilated. Preferably, a plurality of measurements is performed at different flow rates to obtain verification of the measurement for different diffusion capacity values. This can be realized by adjusting the flow rate in different measurements, using flow controller 9 . In general, diffusion capacity in the natural lung increases when the volume of the lung increases, because lung surface area increases. Therefore, it may be desirable to simulate a normalized diffusion capacity, which corresponds to a defined pattern of variation of diffusion capacity in correlation with volume of the lung. Simulation of measurements of such a normalized diffusion capacity can be realized by making flow controller 9 increase the flow rate when the volume of compartment 4 increases and vice versa. At each point in time a flow rate that is a predetermined function (e.g. a linear function) of the volume at that point of time may be set for example. Alternatively, both the volume changes and the flow rate may be controlled as predetermined functions of time. In this way, a more accurate evaluation of measurements of normalized diffusion capacity under natural breathing circumstances can be realized. FIG. 2 shows a low-end solution for use in testing a Single-Breath (SB) measurement device. The normal procedure for the SB-measurement is as follows: a patient breaths normally (phase I), and subsequently a technician ask the patient to take a deep breath in until Total Lung Capacity is reached (phase II). Thereafter during 10 seconds the breath is held (phase III), after which an expiration follows (phase IV). In this case a much simpler embodiment of the CO-TS can be used. The basics of this CO-TS are the same but a much simpler conditioning is used. In this set-up there are a first, second and third valve 19 , 20 , 21 . The compartment 4 with piston can be connected to the device under test, output connection tube 7 or input connection tube 6 via first valve 19 , second valve 20 and third valve 21 , respectively. In most situations valve 19 is already incorporated in the device under test. During phase I and phase II, the volume is connected to the device under test (first valve 19 open and second and third valves 20 and 21 closed). At the end of a simulated deep breath-in, first valve 19 is closed and third valve 21 is opened. Then a predefined amount of gas is squeezed out of the compartment 4 , through the canister 1 into the volume space inside a bellows 17 by moving the piston in (Phase III-a). Thereafter, the third valve 21 is closed and second valve 20 is opened, and the same amount of air is sucked out from the space inside bellows 17 back into the volume space (number 4 ) by pulling the piston with the same amount (phase III-b). Then again second valve 20 is closed. Thereafter first valve 19 is opened, where after expiration follows (phase IV). This procedure must be performed within the time-window between closing and opening of first valve 19 , e.g., by performing phases IIIa an IIIb during ten seconds, which corresponds to the duration that the air remains breathed in a SB experiment. The amount of gas that is led through the canister is again a measure for the DLCO. The inner volume of gas space of the cannister 1 and the connecting tubes 6 and 7 is preferably as small as possible. The volume of space inside bellows 17 is constructed such that it is as low as possible before Phase III-a is started. First valve 19 will be under control of the device under test. Second and third valves 20 and 21 can be one-way valves that open in response to a small pressure differential in one direction. In the embodiment of FIG. 2 the simulated DLCO value depends on the volumes of compartment 4 and bellows 17 . If the initial volume of compartment 4 equals V 0 and the volume with simulated inhaled air V 1 (=V 0 +VI). The volume change of bellows 17 is designated by VP. In this case the CO concentration in exhaled air is reduced by a factor rCO=VI/V 1 *(V 1 −VP)/V 1 and the inert gas concentration is reduced by a factor rIG=VI/V 1 . These factors are substituted in eq (1) of the SB-method. Hence the simulated DLCO value is DCLO=− 1/( R*T )*ln(1 −VP/V 1)/ BHT*V 1  eq(2) Different DLCO values can be set by selecting different values of V 1 and VP, for example by varying the extent to which bellows 17 is extended, or by selecting the initial position of the piston. As will be appreciated the results of the measurements of both apparatus can be used to decide whether the apparatus functions properly. In a further embodiment the results of such evaluation measurements can be compiled into a calibration factor or a calibration table to calibrate operating parameters of the apparatus for measuring DLCO. For example, output signals of a gas analyser in the apparatus for measuring DLCO could be calibrated directly, or as part of the overall apparatus for measuring DLCO, by determining calibration values that are needed to obtain a predicted DLCO value given a simulated diffusion capacity value realized with a flow rate used during calibration. This may be repeated for different flow rates in order to obtain a calibration table in the case of a non-linear response; but in some cases a single measurement may suffice to define a calibration factor. Such calibration data may be programmed into the DLCO measurement apparatus for conversion of measurement results during subsequent use with one or more persons, for example during a predetermined time period (such as a day or a week). Alternatively, a written table for use by an operator may be generated for example. In a further embodiment calibration data may be gathered for a variety of breathing conditions, so that breathing condition dependent corrections to computed DLCO values can be provided. In this way, no conditions need to be imposed on the way of breathing of the person under investigation. Thus for example, measurements are possible on a person that is unconscious or otherwise incapable of following instructions. In a further alternative, the calibration may be performed for a single person at a time, the pattern of volume changes, setting flow rates, flow rate changes in correlation volume changes etc. until they correspond to those of the person under investigation.

1a

FIELD OF THE INVENTION [0001] This invention relates to cognitive assessment that pertains to a smooth pursuit cognitive performance test in which test difficulty varies to establish peak cognitive performance. BACKGROUND OF THE INVENTION [0002] As shown in U.S. patent application Ser. No. 13/507,991 filed Aug. 10, 2012 incorporated herein by reference, it is now possible to measure cognitive performance using eye tracking to an accuracy and consistency level not heretofore possible. While smooth pursuit eye tracking is known, the ability to eliminate environmental factors and the position of the head provides the opportunity to make quantitative measurements of cognitive performance that are reproducible and can be correlated to both cognitive performance and cognitive impairment. [0003] Thus, while smooth pursuit eye tracking in the past has yielded relatively coarse results such as shown in US Patent Applications 2011/0205167 and 2008/6309616, in which a moving dot is made to trace a particular pattern, the ability to accurately measure the lead and lag times of the eyes of an individual tracking a dot on the screen and measure for instance the regularity by which an individual can track a dot yields a new paradigm in eye tracking. For instance, while Messengill shows how a dot can be moved in various patterns, there is no indication of the difficulty of the test, or any correlation with test difficulty. [0004] With the above new-found cognitive performance paradigm, not only can cognitive performance be quantified, but it is now possible to assess an individual's peak cognitive performance by stressing the individual in a controlled manner to ascertain peak cognitive performance with a high degree of accuracy. [0005] The utility of accurately accessing peak cognitive performance lies in more accurate diagnosis of impairments, better understanding of drug testing reactions and better localization of a mental impairment such as better detection of brain injury and its effects. [0006] Moreover, one can also quantify cognitive enhancement. Note that cognitive enhancement involves improvement in thought speed, reaction time, short term memory recall and simultaneity of thought akin to parallel processing in the computer arts. [0007] It has been thought that by massively increasing the frame rate for high performance eye tracking that one can obtain better data. However, aside from the artifacts that naturally accompany high frame rates, the environmental noise including sources of light, head movement and density of tears cause high speed trackers to develop error or jitter at high frame rates. This error swamps the distance the eye moves between consecutive frames. Thus, it is possible to degrade the measurements involved in determining gaze direction if one samples too fast. [0008] However, it is also possible to degrade the measurement by sampling too infrequently, which results in missing saccades and any variations of the eye movement while following the path. It has been found that the ideal frame rate is between 15-150 frames per second. [0009] The industry focus on frame rate for accurate cognitive measurements has been found to be somewhat misguided, as to what is necessary to measure the function of the brain as the eye tracks the moving dot. This has to do with the eye muscles and the thought processes, automatic, reflex-based, autonomic, or cognitive, involved in tracking a moving dot. It has been found that cognitive performance is better measured by measuring the regularity of the variability of the eye in anticipating the next position of the dot. This is because this metric measures the effectiveness of the automatic nature of the circuit in the brain responsible for anticipation. [0010] By way of further background, in the current state of cognitive testing, several dominant paradigms of testing exist, which include surveys, reaction time tests, motion based testing, imaging, biomarker tests and eye tracking. [0011] The survey is perhaps the oldest mechanism and method for testing cognitive impairment. This traces its origins back to the early observation of a physician asking the patient or subject about how they felt to determine the severity of a reported impairment to diagnose the cognitive impairment. This has evolved with time to a full third party assessment of the patient's cognitive performance through surveys and questionnaires run by a trained physician or clinician. Today, these surveys take place in the form of online tests with multiple choice or open-ended questions, administered from anywhere from in a fairly controlled environment to testing at home where the patient controls the environment. These surveys are also the most dominantly used paradigm of cognitive testing as the format in which they are administered is the most open ended and adaptable, giving flexibility to the test designer. [0012] Despite its flexible format, surveys suffer as an accurate cognitive testing method because their inputs are qualitative. Qualitative surveys lend way to a vague metric, which makes it difficult for the test taker to give accurate answers. In addition, the scoring algorithm and calculation utilized to form conclusions from these surveys too become a qualitative one, giving the test administrator too much room for subjective analysis of the survey answers. [0013] Reaction time testing builds on surveys by measuring and testing one's reaction time to a certain question to determine cognitive performance. These questions come in simple and complex form. A simple question might include pressing the button whenever an object appears on the screen. A more complex question might involve the patient having to make a decision about something that's presented, for instance it might entail pressing the button when an object appears on the screen only if that object is green in color or only if that object can be used in a kitchen. Thus, the reaction time for such a question is based on the patient or subject's decision-making process involving recall or memory and other associated functions. The lag time associated with responding to these reaction time questions is usually measured in milliseconds today, with the use of computers. [0014] Reaction time tests, however, are highly variable from test to test, resulting in fairly low and unstable “test-retest reliability”. The low “test-retest reliability” stems from one main problem. The problem is that the brain does not appear to react in the same way to the same stimuli every time. In other words, the same test administered in some circumstance may be administered in exactly the same circumstance and exactly the same situation at a time later, yet still yield different results due to the many variables in play regarding the test taker. Such variables include the degree of attention, emotional changes, metabolic rate and fatigue of the test taker. Also, the thoughts occurring in the patient's mind at the time of the test as well as the preconditioning associated with the test itself can affect the performance of the test taker's reaction time. It is also important to mention that these variables may be changing throughout the duration of one test, let alone different for one test than another. This is magnified by at home or portable field-administered testing. All these variables also factor into some of the sources of error with the “test-retest reliability”. [0015] Due to the low “test-retest reliability”, reaction time tests are generally administered a number of times and that number can be anywhere from a dozen to hundreds or thousands of times. The results from these multiple tests are then averaged together. This then adds on more sources of errors that come with mathematical methods such as standard deviation, variation and mean, which aggregate data into a single, compressed metric. The problem with this and its associated data cleansing and normalization methods of dropping statistical outliers is that altogether, the end result is extremely variable on the decisions one makes while cleaning up the data. [0016] Another paradigm of cognitive testing involves the analysis of patient movement or motion. The most common type of motion testing being balance based testing. Balance based testing tests one's vestibular function, which is the function associated with one's balance. The vestibular function is primarily driven by the brain's ability to detect and monitor certain inner-ear channels and other sources of sensory data for the human body orientation, such as the positioning of limbs and stability of the body and the core. Therefore, the theory of balance-based testing is that impairment in the brain's circuit between monitoring these balance-sensory inputs in the brain and the mechanical feedback of motion of the body will result in the impairment of one's ability to balance. Examples of balance based tests include asking a patient to walk in circles, walk on top of objects, which can be rounded or shaped in ways to purposefully throw the patient slightly off balance or off guard, in order to test one's ability to rebalance or react to the external stimuli. In some cases, a patient is asked to simply sit or stand while a set of optics or movement measuring sensors and devices are employed to determine if the patient is moving in some way that may be predictive of a set of movement that is commonly seen when a cognitive impairment is present. The data generated by these motion-testing processes is often continuous data streams and they are often at a level of resolution that makes smoothing algorithms viable because the impact of the filter or algorithm does not overwhelm the data set. As a result, the data sets produced from these continuous type tests are superior to the reaction test paradigm or the imaging paradigm. [0017] However, motion based testing processes have problems of their own. Most of the motion based testing involves technologies and devices such as cameras and mechanical sensors like accelerometers and gyroscope sensors. These technologies are unfortunately very noisy due to the impact of the environment and normal patient movement. In fact, the signal to noise ratio for the human body movement tends to be very difficult to pick up, or if the features are present, they are very difficult to analyze using normal algorithms. As a result, the algorithmic complexity for filtering out the signal from the noise in some cases introduces more different types of error that make motion based analysis unpredictable and unreliable. In other words, algorithmic analysis is no better than subjective observation, and so this testing paradigm fails as a quantitative metric in practice in the clinic or lab. [0018] Another form of cognitive testing involves the use of what is known as imaging technologies. Imaging technologies are not necessarily limited to optical but could also include signaling and signal analysis. Such technologies include CT, fMRI, magnetic resonance imaging, images of the brain, as well as electroencephalographic (EEG) or magneto-encephalographic (MEG) technology. EEG and MEG technologies monitor the electrical and magnetic characteristics of the brain as produced by the triggering of neurons and metabolizing of chemicals in different sections of the brain as thoughts occur and process inside the brain. In this form of cognitive testing, baseline versus abnormal or off state analysis can be done by predictably anticipating which regions and circuits of the brain will fire for the baseline testing before an impairment. This allows for a quantitative assessment by comparing where the parts of the brain trigger or trigger sequentially at a slightly delayed or offset rate than that of the baseline normal state, or if different parts of the brain trigger in response to certain tests due to neuroplasticity. Such differences would then suggest to the clinician or physician that there was some form of impairment in that portion or pathway of the brain. Similar image comparison can be done for EEG and MEG's waveform signals by analyzing whether certain parts of the brain are timed differently. [0019] Leaving aside the time intensive process of calibration, the problem with imaging technologies is that each of these technologies produces an output with a low signal to noise ratio. This is because the background, static state of the mind, tends to include and involve a fair amount of background noise. This then makes the process of analyzing the output images or signals such as filtering this noise to deduce what part of the brain signal was actually illuminating in response to the test stimuli quite challenging. In the case of EEG and MEG, this output analysis and filtering process is even more difficult as majority of the waveform data points are very brief spikes that even through the use of the best Fourier transforms or filters, isolating the signal is very difficult. Even when the signal is successfully isolated, because the artifact is so brief, it can often be missed and even when found, the idea that the signal is the same strength on successive tests is a statement that is hard to verify in practice. Due to this difficulty with picking out signal to noise, the majority of applications that use EEG, MEG or other imaging technologies, tend to employ signal filtering algorithms of such high dithering state or such high filtering level that the underlying signal becomes lost in the analysis or smoothed over so much that it becomes indistinguishable from other artifacts such as the eye blinking or thinking a thought. [0020] Biomarker or diagnostic based cognitive testing involves looking for biomarkers or trace elements in the bloodstream of a patient in response to certain parts of the brain breaking down or metabolizing chemicals in a certain way. Thus, they link one's cognitive ability to the amount of byproduct of damaged neurons or associated byproducts of cognitive damage as they break down floating in the bloodstream. [0021] The biomarker based testing too, however, has disadvantages as a cognitive test method. As a biological system based testing, one downside of this type of testing method is that it is intrusive. In other words, this class of testing requires some body fluid sampling, which can include anything from an intrusive sampling or nonintrusive sampling of some biological process, such as urine sampling. Sampling related variables such as the sampling method, time of day of the sampling, the metabolic process state at sampling, also introduces sources of error and variability in the data. Another problem is that the output data is not very fine tune resolution grade for several reasons. One reason is that the output data from the biomarker tests tends to be a measure of some kind of very high-level function that occurred that is unknown. Another reason is that the results are dependent on the biomarker's ability to detect the compounds of interest as neurons are breaking down. Furthermore, the output data does not provide any information regarding the location of the brain damage or break down matter. Even presupposing that the resolution of these biomarkers advanced to where they could detect the type of subtleties analytically necessary to isolate the brain damage location, they will never reach a point to provide the x, y, z coordinates inside the brain where damage occurred, nor predict the magnitude of the damage. Another problem with biomarker based testing is that it tends to be fairly expensive relative to noninvasive, less intrusive behavior attribute testing methods. [0022] One of the most promising methods currently employed for cognitive testing is eye tracking because optical testing is noninvasive, shown to have high test-retest reliability and generates a fairly continuous, quantitative data set, allowing for various types of analysis. It is this type of testing that is showing the most immediate applicability, and therefore the type that we expand on in this patent. Smooth Pursuit Eye Tracking [0023] Among eye tracking, smooth pursuit eye tracking is currently the most promising method of cognitive testing. In smooth pursuit eye tracking, a patient is asked to follow a target that is moving on a screen while a patient's eyes are monitored to see how closely the patient can follow that target on the screen or on the projected monitor. It has been discovered by others in the prior art that patients that are able to track the target very carefully and smoothly with small movement, have a greater level of cognitive ability or stability. On the other hand, patients that are less predictable or more erratic in their tracking of an object that is moving in a smooth path are shown to have some form of cognitive impairment or some detrimental attribute of the circuit in the brain that is responsible for tracking smoothly moving objects. This part of the brain that is responsible for tracking smooth movement in objects appears to involve several complex higher order functions within the brain, in addition to the lower order functions involved with the basic vision. Thus, if there is lack of ability or impairment in the ability to follow smoothly moving objects, it is safe to assume that there is likely some impairment in some portion of the brain that's involved in the circuit. What is also intriguing is that the circuit that is involved in performing smooth pursuit appears to track all around the brain from the optical processing center to the rear of the brain, to the neo cortex, with respect to time and anticipation. Thus, the breadth of the test and the breath of the number of circuits required to do the test are actually a tremendous feature of smooth pursuit analysis. [0024] For a long time, smooth pursuit eye tracking has been used by physicians as a simple test to gage whether a patient has a concussion for a long time in the form of linear smooth pursuit. The simple test involved holding a finger up and moving that finger to the left and to the right while asking the patient to follow their finger with their eyes. If the patient's eyes jumped around somewhat sporadically while trying to do so, a movement now known as “saccading”, then the patient was suspected of some form of impairment in smooth pursuit, cognitive ability. The naming comes from the fact that the patient's eyes are asked to move in only one line direction, from one extreme to the next along a same line or axis. Today, the linear smooth pursuit eye movement test has been translated into a number of implementations and embodiments including mechanical devices that swing an object from one extreme to the next to an eye tracking method, where a monitor or a projector moves a dot or target. [0025] Linear smooth pursuit eye movement has many downsides. One downside is that the data produced from the linear movement has major disruptions if digitized because the extremes of the eye movement from one end to the next involve the eyes changing the directions in the opposite direction that they entered the corner into. The result of this is that the eye data, for instance, the location of the eye that is being tracked, stops to the end of the data set and then reverses. Unfortunately, when performing analysis of variation in the difference between the eyes and the target location, the data of these extreme corners need to be canceled and nulled out for an accurate data analysis. This is because there's a fairly large learning effect present for the patient's brain as they begin to realize what the extremes of the linear motion are. This then leads to anticipating, thus slowing down their eyes to some degree before reaching the edge of the target extreme, which is no longer an accurate tracking a moving object with the eyes. Also, as the patient learns the locations of the extremes of the test, they stop smooth pursuit movement to the extremes and instead begin saccading over to the edge. The process of making saccades over to the edge of the test is a negative one because it involves a different part of the brain. It should also be noted that saccading is a more primitive function than smooth pursuit movement. As linear smooth pursuit eventually involves the patient to change their test taking method to merely a saccade, it is a very flawed type of smooth pursuit. [0026] A significant improvement over linear smooth pursuit is the circular smooth pursuit eye movement. Circular smooth pursuit involves a target object moving in a circular motion, clockwise or counter clockwise, while tracking to see whether the eyes are following the smooth pursuit object. The data from circular smooth pursuit does not suffer the same problem as linear smooth pursuit suffers because of the continuous nature of the data set. As circular smooth pursuit's data set moves in a full circular form, there are no breaks or edges like those in linear smooth pursuit. The circular smooth pursuit eye movement generates a continuous set of data of x, y coordinates and a time stamp of the eye as well as the target location. Thus the analysis of circular smooth pursuit eye movement involves some form of comparison of where the eye should have been versus where the eye was actually looking. Some of the most popular analytical techniques to do this include analysis of variance, standard deviation, mean, median, mode and other statistical methods including correlation, auto correlation and regression. These analytical techniques help characterize the variation or difference between the eye and the target position in a compressed, smaller set of numbers that summarizes the entire data set. These few numbers are then further compressed for a scoring system or a performance ranking system. [0027] The benefits of continuous smooth pursuit eye movements, which circular smooth pursuit generates, have been discussed in the prior art in the patent literature and the general neuropsychology and neuroscience literature, such as the complexity of the tests and the breaths of the circuits involved. [0028] However, circular smooth pursuit has a few problems including some that this patent improves upon and addresses. One major downside of the circular smooth pursuit is that there is still a “learning effect” present. Because the target moves in a fixed circular path, the test taker can eventually memorize the radius of the circle and trace a circle with their eyes in a fairly predictive manner. This is a problem because when the test takers begin to memorize or learn the shape of the target motion, the test takers tend to revert back to some form of saccading. As mentioned before, saccading is different from the higher brain functions involved in smooth pursuit. Thus, the saccades can distort the test results and no longer testing the function of the brain of interest. [0029] Both linear smooth pursuit and circular smooth pursuit have another common problem: the blink issue. Whenever the patient blinks, the data portion of the blink has to be nulled out. This causes the data set to be broken up into multiple long segments, which affects the analysis of the data. The detection and filtering of blinks is known and described in the prior art. Eye Tracking Technology [0030] One of the major problems with smooth pursuit eye movement analysis is that it is highly reliant upon the eye tracking techniques used to find the eye position. Before, the patient's eye position was merely observed by a physician or a trained clinician during the test. Currently modern practice utilizes eye tracking technology to determine the eye position, which is more objective, quantitative and accurate. [0031] Despite the technological advancement in eye tracking, eye tracking systems or devices have many problems. One problem is that eye trackers require a great amount of calibration. Often times the calibration of the eye tracker takes a tremendously longer amount of time than actually running the test. A trained professional can spend anywhere from 15 minutes to 30 minutes or more for the calibration process alone. This is because of the many variables that differ from person to person that affect eye tracking such as facial features, eye color, the characteristics of the surface of the eye and the inter-ocular distance. The inter-ocular distance is the distance between the eyes and it varies across a population. On top of these variables, calibration is required to take into account the environmental differences as well. Although some patents and literature have proposed solutions of self or auto calibrating to fix the calibration problem, but these calibrations are not very accurate. Another problem with eye trackers is that they are fairly expensive and complex, thus requiring a trained professional, which adds onto the cost. Eye Tracking with Mechanical Input Testing [0032] Existing technologies have contemplated the use of mechanical input source to follow or trace a moving icon, picture or dot on a computer screen as a test of alertness. These tests and the patents associated with these follow research into a field where alertness is based on the ability of one to follow the moving picture. However, these technologies do not focus on the algorithm to analyze the data captured by such tests to effectively and quantitatively determine if the user has a cognitive impairment and perhaps even what type of cognitive impairment the user has. Instead, these tests simply focus on the qualitative ability of someone to follow a moving target on the screen, and especially as a metric of alertness. SUMMARY OF INVENTION [0033] In order to quantify peak cognitive performance, in the subject invention involving eye tracking of, for instance, a dot on a screen, rather than moving the dot in a regular and predictable fashion, an icon or dot is made to move in a pattern that can be varied to control and controllably set the difficulty of the tracking test. Note that the subject system is applicable to a number of different tests including eye tracking, mechanical tracking or a hybrid combination thereof. Moreover a wide variety of input devices can be used including a number of sensors and those involving different measuring technologies either eye, mechanical, hybrid, or other input driven, for instance, via sensors, or measurement technologies. [0034] Additionally, there are a number of metrics useful in determining cognitive ability when using smooth pursuit cognitive testing. These include anticipatory timing, variability, reliability, and predictability and are defined as follows: [0035] For purposes of the subject invention anticipatory timing means measuring the lead or lag time of an individual's response to tracking a smooth pursuit target icon to anticipate the future position of the icon. [0036] Variability means the distance error as the individual follows the target icon. [0037] Regularity means the consistency of any smooth pursuit tracking measurement, with maximum consistency meaning that the errors over time are the same. [0038] Predictability means the degree to which the test subject's past input and errors can predict the next input. [0039] There are thus a number of different metrics by which one can quantify and assess cognitive behavior that are described in U.S. patent application Ser. No. 13/506,840 filed May 18, 2012 and Ser. No. 13/507,991 filed Aug. 10, 2012. [0040] In one embodiment, the ability to track a moving icon better measures cognitive performance when the smooth pursuit icon movement pattern is varied in complexity, which in turn varies the degree or level of difficulty of the eye tracking test. It has been found that by varying the degree of difficulty one can more accurately assess peak cognitive performance. [0041] In particular, the degree of difficulty is increased in stages until an initial failure to track the moving icon or dot occurs, which establishes a threshold. Once the failure threshold has been established, the difficulty level of the test is oscillated around an average difficulty centered on or about the failure threshold, and this oscillation begins with a difficulty level just below the failure threshold. The subject system then measures the regularity of the eyes' response, with more regular tracking indicating greater cognitive ability and with less regular tracking indicating cognitive impairment. It is a finding of the subject invention that the degree of impairment is more accurately measured at just below the point at which the eye is no longer able to track the moving icon or dot, or just below a point of failure that is established as a result of a controlled program of difficulty that stresses the patient in order to establish a maximum in the peak cognitive state of performance. Thus, by gradually increasing the difficulty up to a failure threshold and then measuring the response of the eye, one is more able to accurately determine peak cognitive ability. Note that pattern complexity can be varied in a number of ways including dot speed, dot acceleration, path undulation, undulation amplitude, undulation frequency and path pattern changes. [0042] More particularly, for impairments of attention, including attention deficit hyperactivity disorder (ADHD) and mild traumatic brain injury (mTBI), the subject system more accurately detects peak cognitive performance than do systems in which the degree of difficulty of the test is not altered. This is because impairment sometimes manifest itself, especially initial impairments, as a degradation of maximum ability, instead of as a detectable reduction in some baseline. Tests measuring only baseline cognitive ability will not measure peak impairment until the degradation in peak ability has reached a level severe enough to impair normal baseline state. For instance in trying to measure the onset of Alzheimer's disease, trying to detect from a baseline does not give enough early warning because the impairment drop off relative to a baseline occurs much like in the disease progression. However by measuring peak performance for instance on a yearly basis results in peak performance data what will disease over time in a manner that is recognizable long before baseline analysis yields an indication. By bringing the test subject up to the point of failure and oscillating the degree of difficulty around this threshold one can sense peak cognitive performance, with the peak being defined as the point at which the individual fails to track the dot. [0043] In one embodiment the present invention is a hybrid eye and mechanical movement cognitive test in which a test subject is made to trace a moving dot while following the moving dot with his or her eyes. Thus, eye tracking and the ability to move a mechanical input, such as a pen, to follow a corresponding dot on a tablet or screen assures the highest accuracy of peak cognitive ability. As a result in one embodiment the test is a combination of continuous motion normal dexterity testing and smooth pursuit eye movement testing. The benefits and features of both are brought into an environment where these variables are tested in parallel and simultaneously, independent of each other, in a complex multimodal multisensory cognitive test. [0044] The test can be broken down into four different phases: target matching, cognitive calibration, change of degree in difficulty and stasis. [0045] The test initiation constitutes the first phase of the test called target matching. The test begins as a prerecorded or pre-scripted initial set of path motion for an icon to follow the screen. The user attempts to match the location of that target using some type of mechanical input, or visual/optical input. [0046] The second phase of test administration is the cognitive calibration. As the target advances and continues to move using some type of fluid motion, typically in a line, an arc, a curve or a sinusoidal shape, the user initiates his or her attempt to follow and replicate that path. In this phase, the user begins to match and adapt to the test, assess how difficult the test will be and also begins to memorize or learn how to modulate his or her mechanical extremities in order to best match the target moving on the screen. This initial phase is critical and pivotal in measuring how quickly the user can learn to match the moving target. [0047] As the test continues, the test begins to stabilize as the patient is normalized over some period of time. At this point, the user is thought to be perfectly tracking the movement of the target as best as possible at the current state of ability and to have overcome the learning effect through a simple amount of memorization of how the test will proceed. [0048] This leads to the next phase called change of degree of difficulty. This is when the test takes into account the performance of the user and incorporates this into changing the parameters or behaviors of the target itself to change the degree of difficulty that the user is subjected to. For a continuously semi-linear motion, the velocity can be made to accelerate. For a continuously arcing path, the radius of curvature may be made to decrease, increasing the curvature angle. For a sinusoidal pattern, the amplitude or the frequency of the sinusoidal motion may be made to increase, which over a period of time will become a more chaotic motion, making it very difficult for the user to follow and match the target. Such various parameters are changed to increase the difficulty of the test to test the user's performance. Degree of difficulty is therefore thought to be specified as a function of a number of variables, including velocity of target, arc of target, predictability of motion path, visibility, continuity of visibility, frequency of alteration in the variables aforementioned. [0049] By the end of this phase, the test has now quantified the maximum state of cognitive performance by having ramped up the difficulty of the test to a point where the user can no longer respond or match the increasing complexity of the test difficulty dimensions. However, it should be noted that the objective of this phase is to determine the user's maximum state of cognitive performance as quickly as reasonably possible via an accelerated ramp up of difficulty. Thus, the user's maximum cognitive ability quantified in this phase of the test is a fairly accurate approximation, but an approximation nonetheless. [0050] The last phase of the test is called stasis. The objective of this phase is to take additional time than the previous phase to hone in, clarify and get further data points around the user's cognitive ability threshold. In order to meet this objective, the difficulty of the test is oscillated in this phase. However, the test does not blindly oscillate the difficulty, but makes use of the maximum ability that the test taker achieved from the previous phase and oscillates the difficulty of the test around that threshold. In other words, the difficulty of the test is modulated to be slightly harder and then slightly easier around the area where the patient is expected to be maximally tested and pushed, which was found from the previous phase. Through this oscillation, the test taker is slowly pushed to difficulty levels higher incrementally in order to get further confirmation that the difficulty level at this stage is really a representation of the most difficult stage level the patient can endure. The result is a series of readings, which measurements are the most meaningful and important data and constitutes the heart of the analysis of the user's cognitive ability. [0051] There are two variables of this last phase that are very important to achieving an accurate final maximum cognitive performance of the test taker, namely, frequency of oscillation and the length of time of this phase. [0052] The frequency of oscillation is very important because an oscillation frequency that is too fast will not allow the test taker to adapt, whereas an oscillation frequency that is too slow could bore the patient. In both cases, the resulting data will not as useful as it could be. Thus it is important that the oscillation period is just long enough to allow the test taker to catch his breath, cognitively speaking, and then re-engage to push to a harder level of difficulty, but not too long to bore the test taker. [0053] The length of time for this phase of the test is also very important. If this phase goes on for too long, other cognitive effects may begin to be in evidence such as distraction, boredom, fatigue, lethargy, lack of will, or neural metabolic exhaustion, which would deteriorate the various cognitive effects of interest. Thus, the timing and duration of this final phase is absolutely critical. [0054] It is important to note that the addition of mechanical input in parallel to the visual input does not confound the test or make it overly complex to mask the effect the test is trying to analyze via smooth pursuit movement. In fact, this enhances the effect the test is trying to analyze. Because the smooth pursuit movement task is a continuous attention task that demands the user's full attention, the addition of the mechanical motion demands an even higher attention threshold. This ensures that the brain of the user is very unlikely to wander during the time he or she takes the test. Therefore, the invention requires a high cognitive load without overloading the patient. This means that this test is an ideal type of cognitive test because the upper bound cognitive load adapts in a relatively dynamic and variable manner to the upper bound of the cognitive load of a patient. [0055] In other words, the test gets more difficult as the patient performs better and the test is less difficult for patients that perform less well or that have a cognitive impairment. [0056] It is also important to not confuse the idea of the parallel mechanical task addition of the mechanical motion and the eye smooth pursuit, with a concept known in cognitive literature as dual tasking. Dual tasking utilizes what is known as sequential decision logic process, which requires the same part of the brain to make two sequential decisions before responding to a stimulus. The invention however is not dual tasking as it utilizes a parallel decision logic process. A test that utilizes a parallel decision logic process requires two different parts of the brain, and thus can be activated in parallel, allowing two different logical decisions to be made simultaneously to respond to a stimulus. In other words, the visual smooth pursuit and the mechanical task utilize two different regions of the brain, and thus do not interfere with one another or effect the cognitive test results in a negative manner. [0057] The platform of the invention is a computing device with some type of screen to run and display the test on, such as a personal computer and a monitor, a laptop computer or tablet computer. [0058] Many different types of hardware can be used for the mechanical input test to move the cursor on the screen to follow the moving target. It can be a mouse with a cursor on the screen, where the cursor is a secondary icon attempting to follow the target icon, or a finger on a track pad, a stylus with a drawing pad, or a joystick. Also, a rotary source of input where the user is constrained in just a rotational motion, which has been contemplated in the prior art, could be used as the source mechanical input. [0059] Instead of using a type of hardware for mechanical input, the physical location of the user's limbs and extremities can be used in combination with remote three-dimensional positioning technologies. Also one's balance can be used for mechanical input by tracking the user's head position and movement in combination with similar three-dimensional remote-sensing technologies, accelerometers or movement tracking devices. [0060] Furthermore, any combination of these technologies can be used to measure simultaneously multiple limbs, multiple extremities or multiple sources of balance at the same time. [0061] In following for alertness, visual feedback eye tracking has been described in the prior art. It is the combination of these two together with the addition of a functional thresholding for quantifying cognitive-mechanical synchronicity that is the contribution of this patent. The analysis of data from the previous modalities for this purpose of quantifying mental-physical athletic ability has eluded researchers to this date. [0062] In one embodiment, the analytical process step of the invention is divided into a number of algorithmic processing steps. The first step is the administration of the test, in which this part of the analytical process step and programming is associated with presenting a specific type of icon onto the screen. There are also analytical processing algorithms necessary to control the movement and adaptation of movement over the course of the test. The second step involves a set of analytical processes associated with recording the user input into a data file. The user input is an attempt to match the location of the target icon on the screen and the x, y coordinates of the user location and the time stamp is saved. The third step is a tranche of algorithms dedicated to the saving, storage and preparation of the data file, which contains the user and target location data, into one location. This is important for the ease of the next step, namely analysis. This fourth step contains analytical pieces of algorithms that are specifically designed to analyze the data output and assess the ability of the user to follow the target specifically along a set of meaningful cognitive metrics. The final fifth step is a set of algorithms associated with presenting the results back to the user or test administrator. This includes allowing the user or test administrator to analyze, assess and look at reports. For instance, the results can be trend analyzed over time, a demographic or population statistic. The final piece of analytical process step of the invention is a type of coordination algorithm, which is required to coordinate across all of these pieces of analytical processes. [0063] This invention is an improvement over the existing current state of the art in cognitive testing for several reasons. One improvement is that this invention presents the user with multiple channels of information by showing the target on the screen as well as the location of the mechanical input of the user. This is a very important point of the invention as it provides a channel of feedback immediately back to the user of how well they are doing. In addition, as the test varies in difficulty dependent on the user's performance, another channel of information that communicates to the user how the difficulty of the test is changing, increasing or decreasing can be added as well. One possible way to do this could be to change the target icon's intensity, color or size. This then opens up three different channels of communication: target location, user location and test difficulty. [0064] It is important to mention here that because the invention introduces an extremity, which is cognitively different from the eye itself, the invention separates the eye and the tracking of the eye of a smooth-moving target using some physical extremity, which is attempting to replicate the target location on the screen. This separation of eye and tracking of the eye makes showing the user location on the screen a benefit and not a cognitive distraction, as it would be if it were implemented into eye tracking by presenting a dot representing their current gaze position to the user while taking an eye tracking test. [0065] Unlike most cognitive testing, the invention requires almost no time for setup or calibration. The elimination of calibration from the system cannot be overstated. The significance can be represented by the ability to administer this test with only seconds of setup and configuration time, whereas the nearest comparable type of cognitive test in the eye tracking domain takes at least a few minutes but usually up to half an hour to an hour to calibrate for a single patient. [0066] In addition, the test is relatively straightforward. It can be administered with a simple instruction to take a dot representing a mechanical input or extremity of choice and to follow the moving target on the screen as closely as possible. Such a simple instruction can be understood by all ages and can be administered in any multiple sets of languages. [0067] Also, the mechanical testing paradigm of the invention allows for the ability to use a multiple types of input sources, any of which can represent the user's ability to match the target. This wide array of different sources of input for the test makes this test more appealing or suitable for a wider array of individuals. [0068] Other advantages of the invention's cognitive testing system includes low cost and high degree of portability, as this test may be administered anywhere a computer and mechanical input source are available. The low cost derives from the fact that the test only requires a computing device, if not already owned by a user, and a mechanical input device. In comparison, the nearest comparable type of cognitive test in the eye tracking domain requires expensive optics that cost exponentially more as the frame rate of the camera increases. [0069] In one embodiment, the invention is mechanically based and operates with a set of portable peripherals for the testing input. Thus, this system is highly portable, and significantly more portable than for instance, an eye tracker. BRIEF DESCRIPTION OF DRAWINGS [0070] These and other features of the subject invention will be better understood in connection with the Detailed Description in conjunction with the Drawings of which: [0071] FIG. 1 is a diagrammatic illustration of the detection of peak cognitive performance when utilizing an eye tracking system to determine the ability to track a moving icon on a screen; [0072] FIG. 2 is a diagrammatic illustration of the detection of peak cognitive performance using a manual icon tracking technique to detect peak cognitive performance; [0073] FIG. 3 is a diagrammatic illustration of the use of the subject system to determine peak cognitive performance by tracking a path, finding the instantaneous vector of movement of an icon on the path, finding a normal to the vector and finding the arc path length between the icon and the finger used to track the icon, with a processor driving an on-screen icon and measuring how far off target the finger is to measure cognitive performance and thence peak cognitive performance; [0074] FIG. 4 is a block diagram of a system for the determination of peak cognitive performance, which includes cognitive performance measurement, followed by the determination of the failure threshold where a test subject fails to be able to follow a moving on-screen icon to set a maximum difficulty threshold, which is then utilized as a threshold about which to oscillate test difficulty in order to pinpoint the maximum, peak cognitive performance; [0075] FIG. 5 is a diagrammatic illustration of the use of a not easily anticipated path for a moving icon which takes out the learning affect, in which the path shape allows the testing entity to vary the test difficulty in terms of varying the velocity, number of lobes, size of a lobe, and rate of curvature of the path, with the variability controlled to make the test harder; [0076] FIG. 6 is a diagrammatic illustration of the path of an icon showing increasing test difficulty, with path variation in terms of frequency and amplitude as well as shape to go from a relatively simple path to a complex path of higher difficulty by increasing the number of lobes and varying the icon velocity of the path; [0077] FIG. 7 is a graph of difficulty versus time for a number of different I, II, III and IV phases in the testing procedure; [0078] FIG. 8 is a graph showing performance score versus time for the I, II, III and IV phases; and [0079] FIG. 9 is a graph showing a decrease in cognitive performance with age showing a downward trend for a baseline image, indicating that peak cognitive performance when trended can predict the onset of dementia, Alzheimer's disease and like mental disorders. DETAILED DESCRIPTION [0080] Referring now to FIG. 1 , a portable eye tracking unit 10 that determines the gaze direction 12 of test subject 14 is coupled to a processor 16 which not only drives an icon 18 on a screen 20 , it also detects the direction of gaze of test subject 14 as illustrated at 22 . The construction of such an eye tracking device is described in U.S. patent application Ser. No. 13/507,991 filed Aug. 10, 2012 and determines when the direction of gaze 12 impinges on the moving icon, which in the indicated case moves in a circle as indicated by arrow 24 . The ability to track the icon is determined at 26 which in essence measures the cognitive performance of the test subject by determining the test subject's ability to have his or her eyes track the moving icon. As described in the aforementioned patent application the ability to track the icon is often times measured in terms of the lag time or lead time of the individual's eyes in tracking the icon, called anticipatory timing. [0081] A particularly good metric for determining the ability to track the icon is the variability in the anticipatory timing or, more particularly, the regulatory of the anticipatory timing. [0082] Regardless, a measure of the cognitive performance of test subject 14 is applied to a peak cognitive performance measurement unit 30 , the operation of which will be described hereinafter. [0083] While the cognitive performance of an individual is tested utilizing eye tracking, as illustrated in FIG. 2 the ability to track a moving icon 32 on a tablet 34 that traverses a path illustrated by dotted line 36 measures cognitive performance as illustrated at 38 . In order to perform the peak cognitive performance measuring, the success of following icon 32 is determined at unit 40 in much the same way as the eye tracking system of FIG. 1 . In this instance the pressure of the hand 42 on tablet 34 provides an indication of the position of the end of finger 44 on tablet 34 . To the extent that this position registers with the current position of the moving icon 32 then one can measure cognitive performance though the ability of the finger to track the moving icon. Note, this measures both eye tracking and manual dexterity at the same time. Said two different processes are involved, the test is exceedingly robust. [0084] For purposes of this invention this technique is called mechanical tracking. [0085] Referring now to FIG. 3 , how one measures the coincidence of gaze direction or finger position to a moving icon is shown. Here a display 50 is shown in which a moving icon 52 traverses a path illustrated by dotted line 54 . This path is used to promote smooth eye tracking determinations. The result of the tracking is processed by processor 56 to which a motion algorithm 58 is applied, with processor 56 driving display 50 and icon 52 thereon. It is important note that the degree of difficulty of the test depends upon the motion of the icon and the path that it traverses. For instance, a circular motion which is repetitive is easy to anticipate and therefore is the least difficult test for smooth eye pursuit. One can however produce more than circles on display 50 and the more complicated the path 54 the more difficult the test. Thus, motion algorithm 58 is capable of producing variable difficulty in the test presented to the test taker. [0086] As illustrated at 58 as an output from processor 56 a unit determines how far off the target the eye gaze direction or the position of the person's finger is and therefore establishes through the aforementioned anticipatory timing a level of cognitive performance. It will be appreciated that the maximum level of cognitive performance can be quantified in terms of when the individual cannot perform the test meaning he cannot track the moving icon. Thereafter a threshold 60 can be set to indicate the maximum test difficulty that the individual can successfully complete. [0087] In order to measure the coincidence of either the gaze direction or the finger, one can find the path, find an instantaneous vector of movement of the icon, find a normal to the vector and thereafter find the arc path length between the icon and either the intercept of the gaze direction with the tablet or the finger position. Having found the path arc length one can go about establishing anticipatory timing. [0088] Regardless of the way that a measurement of cognitive performance is arrived at, it is the purpose of the subject invention to determine the peak cognitive performance. [0089] Referring now to FIG. 4 , in order to do so a cognitive performance measurement 62 is performed in any manner commensurate with either smooth eye pursuit or mechanical testing. As seen by module 64 a determination is made as to the maximum state of cognitive performance where a test subject fails the test. This unit also sets a maximum difficulty threshold meaning that test difficulty below this threshold enables the individual to successfully complete the test, whereas a test difficulty above this threshold is one in which the individual taking the test cannot successfully complete the test. [0090] The maximum difficulty threshold 66 determined in this manner is coupled to a unit 68 which oscillates the test difficulty about the maximum difficulty threshold. In order to oscillate the test difficulty the output from unit 68 is applied to a control unit 70 that changes the path movement of an icon on a screen to control test difficulty. This control unit is then coupled to a unit 72 that controls path motion in an ever increasingly or decreasingly difficult test. [0091] Once having initiated the oscillating test difficulty algorithm what is then recorded at unit 74 is the peak cognitive performance during the oscillation. In one embodiment the peak cognitive performance is an average score for the test after a so-called stasis period has established a maximum difficulty threshold. [0092] At the bottom of FIG. 4 is a series of paths 76 and 78 along which an icon 80 is to travel. There are various ways in which to increase the difficulty of a test, with the increase in difficulty being for instance an increase in the speed of the icon, an increase in the number of lobes of the path, an increase in the amplitude of lobes of the path or even a change in icon acceleration, with the difficulty referring to how easy or difficult it is for the individual to track the moving icon. [0093] Referring now to FIG. 5 , it is important to make sure that the moving icon position is not easily anticipated. Here an icon 82 is moved to a position 82 ′ which goes along an irregular but smooth path 84 in the direction of arrow 86 . It is noted that if a non-regular path is presented to the test subject the irregular path takes out any learning effect. Moreover, the particular shape allows the testing authority to vary the difficulty of the test for instance in terms of velocity, number of lobes, size of lobe and rate of curvature or indeed any of a number of different methods by which the ability to follow the moving icon can be made harder. It will be seen that the above offers a means to vary test difficulty such that the test can become harder and in which the difficulty can be easily regulated by the differing complexity of the path on which the icon is to be moved. [0094] Referring to FIG. 6 , what is shown is four different difficulties having to do with path configuration. Here at Difficulty I is shown by the slightly undulating path 90 which presents an icon traveling along this path. The difficulty in following the icon on this path is minimal even though the path is not easily anticipated. [0095] Referring to Difficulty II, path 90 ′ is provided with an increased number of lobes here at 92 , 94 and 96 , with the number of lobes in a path determining the difficulty presented to the test subject. [0096] Referring to Difficulty III, not only can the number of lobes 96 be increased dramatically, also the amplitude of the lobes can be varied such that an icon going along the paths established by these lobes will move either more or less, thus giving the test taker a challenge to be able to track the moving icon as it travels along these paths. [0097] Finally with respect to Difficulty IV it can be seen that the velocity of the icon illustrated by arrow 98 can be of one magnitude as it moves around a lobe 100 , whereas the velocity of the icon as it moves along a straight path stretch as illustrated by arrow 102 can be less. Finally the velocity of the icon illustrated by arrow 103 may be different than the velocity illustrated by arrow 98 as the icon moves around another lobe 106 , such that different icon accelerations can be presented to the test taker. As a result the test difficulty can be varied in a number of different ways from a less difficult test to a more difficult test, thereby to provide different test difficulties for the subject taking the test. [0098] Referring now to FIG. 7 , what is shown that the test is administered in one embodiment in a number of phases. Phase I relates to the initiation of the test in which initial matching is detected for a prescribed set of path motion. Here the test difficulty is either held constant much as illustrated at 110 . After initialization such that the individual is comfortable in taking the test, there is a calibration phase. This is shown by the slight variation of test difficulty. Thereafter in phase II the test difficulty is ramped up significantly as illustrated 112 until such time as the patient or test taker is unable to perform the test as illustrated at 114 by a line 116 that denotes the point at the end of phase II that establishes a threshold. Thereafter as illustrated at phase III the test difficulty is varied very little as illustrated at 118 to provide a stasis period to be able to stabilize on the cognitive ability of the test taker. At the end of phase III the cognitive ability of the test taker is ascertained and more particularly his maximum ability to achieve. For phase IV the test difficulty is oscillated around this threshold level as illustrated at 120 . [0099] All the time that the tests are being performed in varying degrees of difficulty the test taker is scored and the scores are presented as illustrated in FIG. 8 . Here it can be seen that during phase I the score of the test taker improves as he gets used to taking the test as illustrated by line 122 . Thereafter when the test difficulty is ramped up the score 124 decreases to a failure at a threshold point as illustrated at 126 . This failure threshold point is utilized in establishing when the individual is in a relatively stable mode or in stasis, and this is illustrated by the test score illustrated by line 128 . [0100] Upon reaching stasis, the test difficulty is oscillated around the aforementioned threshold and the test score as illustrated by line 130 reflects this such that the test scores reflect oscillation in difficulty just below the threshold level. The average during oscillation provides an accurate indication as to the peak cognitive performance capabilities of the test taker. [0101] It is because one is able to make accurate initial cognitive performance measurements and then to vary the difficulty of the test and oscillate the difficulty around a threshold that the average trace measurement is a valid indicator of peak cognitive performance. [0102] Referring to FIG. 9 , having ascertained peak cognitive performance, this metric can be used over time to measure a decreasing trend of cognitive impairment with age. Here cognitive peaks 140 , 142 and 144 taken at 10 gear intervals indicate a decreasing cognitive performance trend indicated by dotted line 146 . When this trend is compared with a baseline range 150 one can predict when cognitive performance falls below the baseline range as illustrated at 152 . The steepness of trend line 146 is oftentimes a good predictor of the presence of a mental condition such as dementia or Alzheimer's disease. One could predict the likelihood of later life Alzheimer's disease or its onset by establishing the subject peak cognitive performance trend. The ability to accurately keep track of peak cognitive performance has many uses in both diagnostics and for instance the efficacy of cognitive enhancement drugs, with trend lines indicating improvement in cognitive performance when using such drugs. In short, an accurate robust measure of peak cognitive performance opens up many avenues for evaluation and are all due to the ability to robustly measure peak cognitive performance through smooth pursuit tracking and the ability to vary test difficulty. [0103] The mathematical definitions of the metrics used herein are presented below: Anticipatory Timing: [0104] f  ( f ) = 1 N  ∑ j = 1 N   ( ∑ i = 1 N   (  t - i  ) ij - ∑ i = 1 N   (  t - i  ) i ) [0000] The standard deviation of the sum of the absolute value of a set of target position arrays subtracted from a set of user position arrays. N=The length of the target position (the number of elements in the array). j=The standard deviation index for the absolute value target minus user array i=The index for the sum of absolute value target minus user array t=Target position arrays. i=User position arrays. Variability: [0105] f  ( e ) = 1 N 2  ∑ k = 1 N   ( ∑ j = 1 N   ( ( d t - d i ) j - ( d t  - -  d i ) ) k - ∑ j = 1 N   ( ( d t - d i ) j - ( d t  - -  d i ) ) ) 2 [0000] The variance of the standard deviation of a set of target position arrays subtracted from a set of user position arrays. N=The length of the target position (the number of elements in the array). j=The standard deviation index. k=The variance index. dt=Target distance arrays. di=User distance arrays. Regularity: [0106] f  ( e ) = Minimum  [ δ t = 0 t = f  ( ∑ i = 0 i = N   e ) ] [0000] Finding the minimum of the application of the sum of an error array on a delta distribution. e=Error array. N=The length of the target position (the number of elements in the array). t=Time. i=Index of error array. Predictability: [0107] ƒ( t+ 1)= kf ( t −n ,t 0 ) [0000] A factor of k applied to any function listed on this sheet. k=Arbitrary constant. t=Input elements to any function f. Peak Performance: [0108] ƒ( p )=Maximum[scores[ t 0 :t ƒ ]] [0000] The maximum value of any indexed portion of the scores array. to=Beginning index. tf=Ending index. [0109] While the present invention has been described in connection with the preferred embodiments of the various figures, it is to be understood that other similar embodiments may be used or modifications or additions may be made to the described embodiment for performing the same function of the present invention without deviating therefrom. Therefore, the present invention should not be limited to any single embodiment, but rather construed in breadth and scope in accordance with the recitation of the appended claims.

1a

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to treadmills, and more specifically to a lifting mechanism and treadmill arrangement. [0003] 2. Description of the Related Art [0004] A conventional treadmill, as shown in FIG. 1, is generally composed of a base frame 1 , a treadbase 2 mounted pivotally on the base frame 1 , a first motor drive (not shown) located on the treadbase 2 at a front side thereof and adapted to rotate a belt (not shown), a second motor drive 3 , a screw rod 4 coupled to the front side of the treadbase 2 and driven by the second motor drive 3 to lift or lower the treadbase 2 so as to adjust the inclination of the treadbase 2 . [0005] The screw rod 4 has a bottom end threaded into an internally threaded barrel 5 , which is fixedly located on the base frame 1 at an end thereof. When the second motor drive 3 is operated, the screw rod is 4 screwed into or out of the barrel 5 , thereby lifting or lowering the treadbase 2 . However, the treadmill is still defective structurally and includes disadvantages as follows: [0006] 1. Because the screw rod 4 and the barrel 5 are adapted to move oppositely in vertical direction, the second motor drive 3 , the screw rod 4 , and the barrel 5 must be located on the middle section of the treadmill to prevent from unbalance of lifting. This limitation confines the available installation space and orientation for the first motor drive. [0007] 2. In order to install the first motor drive in the limited space between the treadbase 2 and the second motor drive 3 , the first motor drive must be provided with an expensive model of high capacity and small size. [0008] 3.Because the second motor drive 3 and the barrel 5 occupy much vertical installation space, the treadbase 2 cannot be set in a horizontal position. As shown in FIG. 1, the treadbase 2 is positioned with a front end thereof lifted and slopes downwardly backwards at an angle. Many consumers may not like to do exercise on an inclined treadbase. SUMMARY OF THE INVENTION [0009] It is the primary objective of the present invention to provide a lifting mechanism and treadmill arrangement, which is compact and requires less installation space. [0010] It is the secondary objective of the present invention to provide a lifting mechanism and treadmill arrangement, which lifts/lowers the treadbase stably. [0011] To achieve the foregoing objectives of the present invention, the lifting mechanism and treadmill arrangement of the present invention includes a base frame positioned on the floor horizontally, the base frame having a guide frame; a treadbase formed of a treadbase frame and an endless belt; two links bilaterally mounted on the treadbase frame, the links each having a first coupling end and a second coupling end, the first coupling end being mounted pivotally on a front end of the base to form a first pivot point, the second coupling end being mounted pivotally on a front end of the treadbase frame to form a second pivot point, the treadbase frame being turned about the first pivot point with respect to the base frame between an operative position and a non-operative position; a treadbase motor fixedly mounted in the front side of the treadbase frame to rotate the endless belt; and a lifting mechanism including a push member and an inclining motor, the push member having stop means at a front end thereof, the inclining motor being mounted pivotally on the treadbase frame and adapted to drive the stop means of the push member to move back and forth along the guide frame of the base frame. BRIEF DESCRIPTION OF THE DRAWINGS [0012] [0012]FIG. 1 is a perspective view of a treadmill constructed according to the prior art; [0013] [0013]FIG. 2 is a perspective view of a lifting mechanism and treadmill arrangement according to a preferred embodiment of the present invention; [0014] [0014]FIG. 3 is a sectional view taken along a line 3 - 3 of FIG. 2; [0015] [0015]FIG. 4 is similar to FIG. 3, showing that a front side of a treadbase of the present invention is lifted; [0016] [0016]FIG. 5 is another perspective view of the preferred embodiment of the present invention, showing that the front side of the treadbase is lifted; and [0017] [0017]FIG. 6 is still another perspective view of the preferred embodiment of the present invention, showing that the treadbase of the present invention is received in the non-operative position. DETAILED DESCRIPTION OF THE INVENTION [0018] Referring to FIGS. 2, 3, and 6 , a lifting mechanism and treadmill arrangement 100 is composed of a base frame 10 , a treadbase 20 , two links 30 , a treadbase motor 40 , and a lifting mechanism 50 . [0019] The base frame 10 includes two parallel side bars 11 , a transverse bar 12 connected between rear ends of the side bars 11 , a supplementary bar 13 connected between front sections of the side bars 11 , a guide member embodied as guide frame 14 connected between the transverse bar 12 and the supplementary bar 13 and arranged in parallel to the side bars 11 , and a buffer block 15 provided in the guide frame 14 . The guide frame 14 includes two vertical side plates 141 and a bottom plate 142 . The side plates 141 each have a longitudinal sliding slot 143 defining a first dead point 144 and a second dead point 145 . The buffer block 15 is fixedly mounted in the guide frame 14 adjacent to the first dead point 144 . [0020] The treadbase 20 includes a treadbase frame 21 and an endless belt 22 . A receiving space 23 is defined between the treadbase frame 21 and a front side of the endless belt 22 . [0021] The two links 30 are bilaterally mounted near a front side of the treadbase frame 21 , each having a first coupling end portion 31 and a second coupling end portion 32 . The coupling end portion 31 is connected pivotally with a front end of the side bar 11 of the base frame 10 , defining a respective pivot A. The second coupling end portion 32 is connected pivotally with the front side of the treadmill base 21 , defining a respective pivot B. Accordingly, the treadbase 20 can be turned about the pivot A between an operative position P 1 (see FIG. 2) and a non-operative position P 2 (see FIG. 6). [0022] The treadbase motor 40 is fixedly mounted in the receiving space 23 of the treadbase 20 and is controlled to rotate the endless belt 22 through a belt transmission mechanism 41 . [0023] The lifting mechanism 50 includes an inclining motor 51 , an internally threaded barrel 52 , a push member 53 , and stop means embodied as a stop pin 54 . The inclining motor 51 is mounted pivotally on the treadbase frame 21 . The barrel 52 has an end fixedly mounted to the inclining motor 51 . The push member 53 is a screw rod threaded into the barrel 52 . The stop pin 54 runs through a transverse through hole (not shown) at a front end of the push member 53 outside the barrel 52 , having two distal ends respectively inserted through the sliding slots 143 of the vertical side plates 141 of the guide frame 14 (see FIG. 6). When the inclining motor 51 is operated, the push member 53 is rotated in or out of the barrel 52 , thereby causing the stop pin 54 to move along with the push member 53 between the first dead point 144 and the second dead point 145 . [0024] The control of the angle of inclination of the treadbase 20 is described hereinafter. [0025] As illustrated in FIG. 3, when the treadbase 20 is positioned horizontally, the push member 53 is received in the barrel 52 , the stop pin 54 is stopped at the first dead point 144 and the front end of the push member 53 is stopped against the buffer block 15 . When the treadbase 20 is controlled to lift, as shown in FIG. 4, the inclining motor 51 is driven to rotate the push member 53 out of the barrel 52 . Because the front end of the push member 53 is stopped against the buffer block 15 and the links 30 are coupled between the treadbase 20 and the base frame 10 , the push member 53 is rotated out of the barrel 52 and the front side of the treadbase 20 is lifted to change its angle of inclination, as shown in FIG. 5. [0026] When the treadbase 20 is turned to the non-operative position P 2 , the front side of the treadbase 20 is lowered to the position shown in FIG. 3 (where the push member 53 received in the barrel 52 ), and then a rear side of the treadbase 20 is lifted with hands. When turning the treadbase 20 about the pivots A to lift the rear side of the treadbase 20 , the stop pin 54 is moved along the sliding slots 143 toward the second dead point 145 , and at the same time the inclining motor 51 is rotated for enabling the treadbase 20 to be smoothly turned about the pivots A to the position shown in FIG. 6 where the stop pin 54 is stopped at the second dead point 145 . Lock means may be used to lock the treadbase 20 in the non-operative position. Because the lock means can easily be obtained from known techniques and is not within the scope of the claims of the present invention, nor further detailed description in this regard is necessary. [0027] According to the aforesaid description, the present invention has advantages as follows: [0028] 1. When the treadbase 20 is set horizontally, as shown in FIG. 2, the treadbase motor 40 and the inclining motor 51 are received in the receiving space 23 without interfering each other, i.e. the treadmill does not occupy much vertical storage space when set horizontally. [0029] 2. When the treadbase 20 is set in the operative position P 1 , the lifting mechanism 50 is held horizontally without hindering the front end of the treadbase 20 . [0030] 3. The front side of the treadbase 20 is controlled to stably lift by means of the support of the lifting mechanism 50 , the guide frame 14 of the base frame 10 , and the links 30 .

1a

This application is a continuation, of application Ser. No. 07/346,759, filed May 2, 1989 now abandoned. FIELD OF THE INVENTION This invention relates to an improvement of a noncontact type tonometer, in which the intraocular pressure of an eye to be tested is measured by projecting fluid toward the cornea of the eye and transfiguring it. BACKGROUND OF THE INVENTION Heretofore, in noncontact type tonometers, as alignment verification, the vertical and horizontal positions of optical systems of an apparatus body were verified with respect to the eye and the working distance between the eye and a nozzle for discharging fluid toward the eye was verified. In conventional the noncontact type tonometers, an alignment target light may be projected toward the eye from the axial direction of the nozzle in order to verify the alignment. Noncontact type tonometers of this type are designed such that upon verification of the alignment, fluid, such as air pulse or the like, is discharged from the nozzle to transfigure the cornea of the eye and measure the intraocular pressure thereof. (e.g., Japanese Patent Publication No. Sho 56-6772). However, in conventional noncontact type tonometers of this type, an alignment target light, when the alignment is proper, is made incident to the cornea of the eye from the perpendicular direction as if the alignment target light is converged to the center of curvature of the cornea to form a virtual image. The virtual image is reimaged on a reticle plate, and then the alignment is determined from the sharpness of the reimaged virtual image and from the position tonometers of the virtual image on the reticle plate. In conventional it is difficult to determine correctly and rapidly if proper alignment exists. Also, it is designed as such that the anterior portion of the eye cannot be observed. Accordingly, the inspector of the eye has no way to recognize the state of the eye during the period of time from the aligning operation till the fluid discharge and thus inconvenient. For example, if the discharge of fluid takes place when the lid of the eye to be tested is closed, the obtained value of the intraocular pressure becomes unreliable. SUMMARY OF THE INVENTION It is therefore the object of the present invention to provide a noncontact type tonometer, in which the alignment can be verified correctly and rapidly, and in which reliability of the intraocular pressure measurement can be improved. In order to achieve the above object, a noncontact type tonometer according to the present invention includes a nozzle for discharging fluid toward an eye to be tested; an alignment target projecting optical system for projecting an alignment target light used for aligning the eye and an apparatus body toward the center of curvature of the cornea of the eye from the axial direction of the nozzle while converging the same thereto by an objective lens and forming a virtual image at the center of curvature of the cornea; and an alignment light receiving optical system for reimaging the virtual image on a light receiving portion as a target image; the improvement is characterized in that said alignment light receiving optical system is provided with a light splitter adapted to split an alignment target light for forming said virtual image based on specular reflection of the cornea and guiding the same to said light receiving portion in order to verify the alignment with reference to coincidence or noncoincidence of the alignment target image. A noncontact type tonometer according to a second embodiment of the present invention further includes an illuminating light source for illuminating the anterior portion of the eye and an observing optical system for observing the anterior portion. A noncontact type tonometer according to the present invention is of the type wherein an alignment target light, when the alignment is proper, is made incident to the cornea of the eye from the perpendicular direction so that the alignment target light is converged to the center of curvature of the cornea to form a virtual image at the center of curvature of the cornea. The alignment is verified by the separation and the subsequent coincidence of a plurality of alignment target images. Therefore, the alignment can be verified correctly and rapidly. Moreover, reliability of the intraocular pressure measurement can be improved. Also, the inspector can recognize the state of the eye during the period of time from the alignment operation till the discharging of fluid. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 through FIG. 6 show a first embodiment of a non-contact type tonometer according to the present invention; FIG. 1 and FIG. 2 are views showing an optical system of the first embodiment; FIG. 3 is a plan view of a filter shown in FIG. 1; FIG. 4 is a schematic view showing the image of an anterior portion of an eye to be tested and an alignment target image formed on a CCD when a reduction lens shown in FIG. 1 is inserted; FIG. 5 is a schematic view showing the image of the anterior portion and the alignment target image formed on a CCD when the reduction lens shown in FIG. 1 is not inserted; FIG. 6 is a schematic view for explaining the function of the reduction lens shown in FIG. 1; FIG. 7 and FIG. 8 show a second embodiment of a noncontact type tonometer according to the present invention; FIG. 7 is a schematic view for explaining the inconvenience of the first embodiment; and FIG. 8 is a view showing an optical system of the second embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENT The embodiments of a noncontact type tonometer according to the present invention will be described hereunder with reference to the accompanying drawings. FIG. 1 through FIG. 4 are illustrations showing a first embodiment of a noncontact type tonometer of the present invention. In FIG. 1, 1 denotes an optical system of a noncontact type tonometer, E denotes an eye to be tested, C denotes the cornea of the eye, and R denotes the retina of the eye. The optical system 1 includes a fixation mark projecting optical system 2, an alignment target projecting optical system 3, a nozzle 4, an alignment light receiving optical system 5, a reticle image projecting optical system 32, an illuminating light source 7 for illuminating the anterior portion of the eye E, and observing optical system 8, and a cornea applanation detecting optical system 9. The fixation mark projecting optical system 2 generally comprises a visible light source 10, a condenser lens 11, and a fixation mark plate 12. 12a denotes a fixation mark. The fixation mark plate 12 is illuminated by the visible light source 10 to emit a fixation mark light P 1 . The alignment target mark projecting optical system 3 generally comprises an infrared light emitting diode 13, a diaphragm 14, a dichroic mirror 15, a total reflection mirror 16, a collimator lens 17, a half mirror 18, and an objective lens 19. The dichroic mirror 15, the total reflection mirror 16, the collimator lens 17, the half mirror 18, and the objective lens 19 are also commonly used as the fixation mark projecting optical system 2 in this embodiment. The dichroic mirror 15 permits an infrared light to be transmitted therethrough and to reflect a visible light. Also, the dichroic mirror 18 has such function as to reflect a visible light and to permit an infrared light to be partly transmitted therethrough. A fixation mark light P 1 is reflected by the dichroic mirror 15 in such a manner as to be coaxial with the optical axis of the alignment target projecting optical system 3 and is reflected by the total reflection mirror 16 and guided to the collimator lens 17. The fixation mark light P 1 is collimated by the collimator lens 17. The collimated fixation mark light P 1 is reflected by the dichroic mirror 18 and is projected onto the retina R of the eye E through the nozzle 4. The patient gazes at the fixation mark light P 1 . In case the patient suffers from myopia or hyperopia, a diopter correcting lens 20 may be inserted in an optical path. By this, the patient sees the fixation mark 12a clearly, any external correction. The axis of the nozzle 4 is coaxial with the optical axis O 1 of the alignment target light receiving optical system 5. The alignment target projecting optical system 3 projects an alignment target light P 2 toward the center C 1 of curvature of the cornea of the eye E from the axial direction of the nozzle 4 while converging it by the objective lens 19. The alignment target light P 2 is transmitted through the dichroic mirror 15, reflected by the total reflection mirror 16 and guided to the collimator lens 17 so as to be collimated. The collimated alignment target light P 2 is reflected by the dichroic mirror 18 and is guided to the objective lens 19. When the alignment is proper, the alignment target light P 2 is made incident to the cornea C from the perpendicular direction such that the light P 2 is converged to the center C 1 of curvature of the cornea. And, the alignment target image P 2 is reflected on the outer surface of the cornea C. By this, a virtual image is formed at the center C 1 of curvature of the cornea C based on the alignment target light P 2 . The objective lens 19 is commonly used in the alignment light receiving optical system 5 and the observing optical system 8. The alignment target light receiving optical system 5 includes a dichroic mirror 21, an alignment enlarging projecting lens 22, two a lens 22', dichroic mirrors 23 and 24, a reduction lens 25, and a filter 26 in addition to the objective lens 19. The dichroic mirrors 21 and 23 reflect an infrared light of a wavelength λ 1 and permit an infrared light of a wavelength λ 2 to transmit therethrough. The infrared light of the wavelength λ 2 is used as the alignment target light P 2 . The infrared light of the wavelength λ 1 is used as an illuminating light for illuminating the anterior portion of the eye E (including the iris I). The alignment target light P 2 for forming a virtual image at the center C 1 of curvature of the cornea C based on specular reflection of the cornea C is made into a parallel pencil of rays by the objective lens 19. And, this alignment target light P 2 is transmitted through the dichroic mirrors 18 and guided to the alignment enlarging projecting lens 22. The alignment target light P 2 is enlarged by the alignment enlarging projecting lens 22, transmitted through the dichroic mirror 23 and the lens 22' and guided to the filter 26. The filter 26 includes circular transmitting areas represented by 26 symmetrical with each other with respect to the center. As shown in FIG. 3, two circular transmitting areas 26' are disclosed. These circular transmitting areas, 26' are optically transparent with respect to the infrared light of the wavelength λ 2 and optically opaque with respect to the infrared light of the wavelength λ 1 . The remaining area of the filter 26 is optically transparent with respect to the infrared light of the wavelength λ 1 and optically opaque with respect to the infrared light of the wavelength λ 2 . The dichroic mirror 24 is of the type for reflecting visible light and permitting an infrared light to transmit therethrough. Therefore, when the alignment is proper, the alignment target light P 2 is split into a symmetrical bundle of rays with respect to the optical axis O 1 and imaged on a CCD 27 as a light receiving portion. That is, the filter 26 functions as a light splitter which splits the alignment target light for forming a virtual image based on the specular reflection of the cornea and guides it to the light receiving portion. The observing optical system 8 includes a total reflection mirror 28, an anterior portion projecting lens 29, and a total reflection mirror 30. The illuminating light is incident on the anterior portion and is reflected therefrom. The reflected light is transmitted to the objective lens 19 and the dichroic mirror 18. The reflected light transmitted through the dichroic mirror 18 is reflected toward the total reflection mirror 28 by the dichroic mirror 21 and branched from the optical path of the alignment light receiving optical system 5. The reflected light is guided to the filter 26 through the anterior portion projecting lens 29, the total reflection mirror 30, the dichroic mirror 23 and the lens 22'. And, the reflected light is transmitted to the remaining area of the filter 26 and reaches the reduction lens 25. The reduction lens 26 is inserted between the filter 25 and the dichroic mirror 24 when the working distance l from the apex of the cornea C to the nozzle 4 is roughly adjusted. As is schematically shown in FIG. 6, a ray of light P 0 is emitted from one point P of the anterior portion at angle θ 1 . This ray of light P 0 becomes a ray of light P 0 ' which is converged toward the CCD 27 by the lens 22'. This ray of light P 0 ' is made incident to the CCD 27 at angle θ 2 when the reduction lens 25 is not inserted in the optical path of the alignment light receiving optical system 5. Also, the ray of light P 0 ' is made incident to the CCD 27 at angle θ 3 when the reduction lens 25 is inserted in the optical path of the alignment light receiving optical system 5. Therefore, the angular power is set to r 1 =θ 1 /θ 2 when the reduction lens 25 is not inserted in the optical path of the alignment optical system 5 and the angular power is set to r 2 =θ 1 /θ 3 when the reduction lens 25 is inserted in the optical path of the alignment optical system 5. When the reduction lens 25 is inserted in the optical path of the alignment optical system 5, since the angle θ 3 of the ray of light Po' becomes larger than the angle θ 2 when the reduction lens 25 is not inserted in the optical path of the alignment optical system 5, it becomes r 1 >r 2 . Thus, the power becomes low when the reduction lens 25 is inserted. Therefore, when the reduction lens 25 is inserted, the entire anterior portion image Z is formed in the CCD 27 in its reduced scale as shown in FIG. 4. In case that the working distance l is not proper here, since the alignment target image i formed by the symmetrical bundles of light becomes vague and separated, the inspector can roughly adjust the working distance l by moving the apparatus body along and the optical axis O 1 with reference to the anterior portion image Z. Also, in the case that the optical axis O 1 is greatly displaced in the vertical and horizontal directions with respect to the eye E, the inspector may adjust the alignment by moving the apparatus body in the vertical and/or horizontal direction. The judgement whether the optical axis O 1 is displaced in the vertical and horizontal directions with respect to the eye E is made with reference to a reticle circle 31 formed in the CCD 27. This reticle circle 31 is formed by a reticle image projecting optical system 32. The reticle image projecting optical system 32 generally comprises a visible light source 33, a reticle target 34, and a projecting lens 35. On the other hand, when a fine adjustment is carried out, the reduction lens 25 is removed from the optical path of the alignment light receiving optical system 5 as shown in FIG. 2. Then, the anterior portion image Z is formed in the CCD 27 in relatively enlarged scale with respect to the reticle circle 31. Therefore, the vertical and horizontal displacement of the alignment target image, which appeared to the inspector to be located at the center when the rough adjustment is carried out, can be confirmed according to the relative positional relationship between the reticle circle 31 and the anterior portion image as shown in FIG. 5. The corneal applanation detecting optical system 9 comprises a detecting light projecting optical system 36, and a detecting light receiving optical system 37. 39 denotes a light projector and 40 denotes a light receiver. The wavelength of the detecting light is λ 2 . When this detecting light is being emitted, irradiation of the alignment light P 2 toward the E is stopped. FIG. 7 and FIG. 8 show a second embodiment of a noncontact type tonometer according to the present invention. As is shown in FIG. 7, in the first embodiment, when the reduction lens 25 is inserted in the alignment optical system 5, the angle θ 3 of the ray of light Po' becomes larger than the angle θ 2 of the ray of light Po when the reduction lens 25 is not inserted therein. Therefore, when reviewing the case where the alignment is adjusted in the direction of the optical axis O 1 , the moving range d 2 with respect to the reticle circle 31 becomes smaller when the reduction lens 25 is inserted in the alignment optical system 5 compared with the moving range d 1 with respect to the reticle circle 31 when the reduction lens 25 is not inserted in the alignment optical system 5, and sensitivity of conformity and nonconformity of the alignment target image i becomes high when in low power. If possible, however, sensitivity of conformity and nonconformity of the alignment target image i is desirably raised when the anterior portion image Z is enlarged. FIG. 8 is a schematic view of an optical system satisfying the above requirements. When an anterior portion observing lens 29' of a high power is inserted in the optical path of the observing optical system 8, the reduction lens 25 is inserted in the alignment optical system 5 in such a manner as to interlock with the insertion of the observing lens 29'. Then, since the incident angle θ 2 of the ray of light Po' becomes large, the degree of conformity and nonconformity of the alignment target image i is increased when the anterior portion image Z is formed on the CCD 27 in its enlarged scale. And, when an anterior portion observing lens of a low power (not shown) is inserted in the observing optical system 8, the reduction lens 25 is retracted from the alignment optical system 5 in such a manner as to interlock with the insertion of the anterior portion observing lens of low power into the observing optical system 8. Then, since the incident angle θ 2 of the ray of light Po' becomes small, the sensitivity of separation and conformity of the alignment target image i is lowered when the anterior portion image Z is formed CCD 27 in its reduced scale and the sensitivity of separation and conformity can be changed in accordance with the rough alignment and the fine alignment. Although a plurality of embodiments have been described in the foregoing, the illuminating light for illuminating the anterior portion may be a visible light. In this case, the dichroic mirror 18 is of visible light half transmitting and infrared light half transmitting type, the dichroic mirror 21 is of visible light reflecting and infrared light transmitting type, the dichroic mirror 23 is of visible light reflecting and infrared light transmitting type, and the dichroic mirror 24 is of visible light half transmitting and infrared light transmitting type.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to puzzles and amusement devices. However, in view of the nature of this invention as a new idea for studying self organizing structures, it may also be profitably applied as an educational device, and a device of mathematical interest, and a scientific research device. More specifically, the present invention relates to a puzzle or amusement device incorporating flat strips made of hingedly connected triangles folded into hexagonal loops which loops are then linked together, and the linked loops can then be moved in certain ways with respect to the loops they are linked to, providing a puzzle of great interest with the ability to form many different geometric forms. 2. Brief description of the prior art Because this invention is based upon hexaflexagons, not many patents in this field exist. Hexaflexagons were invented in 1939 by the mathematician Arthur H. Stone. A full explanation of the different kinds of hexaflexagons can be found in "The Scientific American Book of Mathematical Puzzles and Diversions", Simon and Schuster, Inc. NY, NY, 1959, by Martin Gardner. Various toys and puzzles exist that consist of tetrahedrons or cubes hinged together at their edges to form chains, which chains are then sometimes hinged together at their ends to form loops. The puzzle is, then, to fold the object into a given form such as a larger cube or tetrahedron. A well known puzzle is Rubick's Snake which consists of a chain formed of 45 degree wedges pinned rotatably together at the smaller faces into a long chain. Another well known puzzle is the, just introduced, Rubiks Magic puzzle which consists of 6 plastic squares held together by string wound on the diagonal in the manner of a double hinge. None of these chainlike, presently existing, puzzles has both a completely natural form and a natural extendability so that more and more complex and difficult puzzles can be based upon it in the manner of a natural mathematical-like sequence. The present invention is an attempt to remedy this condition by providing a puzzle that is at once so simple that anyone can understand it, yet it can be extended merely by adding more elements to make puzzles of more and more difficulty and complexity, perhaps without a foreseeable end. Since the present puzzle consists of twisted loops of flat hingedly connected triangles it has some of the features of some of the self organizing structures found in biology and is not without interest for mathematicians and scientists and should therefore prove to be valuble in education and research. OBJECTS AND SUMMARY OF THE INVENTION It is the principle object of the present invention to provide a puzzle made of linked loops of hinged triangles that can be folded and, or slipped or shifted into different positions by selectively folding and, or slipping different coded portions of the puzzle and thereby, eventually, completing a cycle of motions that can be repeated over and over until the puzzle finally returns to the beginning position. In this specification any reference to slipping means a gliding motion where one element is folder over another element and so both elements can be caused to move in a gliding motion with respect to each other and the word slip is used to refer to the fact that one thin planar element is being slipped between another thin planar element folded around it. It is a related object of the present invention to provide an educational or amusement device that can be made more complex and difficult by adding more linked loops of hinged triangles, thereby greatly increasing its interest and utility. It is a furthur object of the present invention to provide an amusment or research device that can be used to experimentally derive self organizing properties by examining a given sequence of structures as they are made more and more complex in some given order. The words `self organizing` are justified here because the solution of such a sequence may require a solution of a sequence of forms, each building on properties discovered in the previous orders of the sequence. The DNA molecule is also built of twisted, linked forms and undergoes a great complex of folding and motions. In accordance with the objects of the present invention we begin the invention with the making of a trihexaflexagon. A trihexaflexagon is explained in the literature of recreational mathematics as a strip of 9 equilateral triangles folded into a loop so as to form a hexagonal shape. The strip of 9 triangles can be folded from a rectangular paper strip of 10 equilateral triangles, then glued on the first and 10th triangles after folding into a twisted loop. A trihexaflexagon may be turned inside out by pushing 3 opposite vertices of the hexagon together then folding 3 vertices, from the opposite side, so that the trihexaflexagon opens into a hexagon again. This operation is called flexing. When this operation is repeated several times the trihexaflexagon returns to it's original position, so that code marks or other indicia marked on it resume the exact positions they had to begin with. Since trihexaflexagons are well known in the litereature they, by themselves, are not the object of this invention but do form a basic element of this invention in some embodiements of this invention. Two trihexaflexagons may be linked together by sliding a strip of triangles into a trihexaflexagon and then folding and gluing this strip into a trihexaflexagon as well. The structure produced may then be called a slipagon because it can be both slipped and `flexed`, and it can be specifically called a 2 slipatrihexaflexagon. It is called a sligagon because the 2 looped trihexaflexagons can be slided in relation to one another and the 2 trihexaflexagons may also be folded over and over, and thus flexed independently. If arrows or other indicia are marked on the various trihexaflexagons of a slipagon it is possible to move the arrows about by flexing or by sliping of both by flexing and by sliping. It then becomes a difficult puzzle to get the arrows or other indicia back to their original positions. In the same way that 2 trihexaflexagons can be linked together 3 of more trihexaflexagons can also be linked together to form more difficult slipagons. Even more difficult slipagons can be formed by linking a chain of links back into a loop, thus forming a loop of linked loops. For instance a loop of 6 linked trihexaflexagons forms a puzzle of extraordinary interest, fascination and difficulty. The possibilities for forming more and more difficult and interesting puzzles by this means are truly endless. It is a furthur object of this invention to provide a device that can be dissassembled and reassembled into new and different devices by undoing some of the trihexaflexagon loops and relinking them together in new ways. This provides the user with an endless array of interesting puzzles of any difficulty desired. It is still a furthur object of this invention to provide a device that can be folded and or slipped into new 2 and or 3 dimensional forms from which it is difficult to return, by folding and, or slipping, to it's original form. It is yet another object of this invention to provide a device that can be made of other types of hexaflexagons in any mix such as trihexaflexagons linked to hexahexaflexagons and so forth. The more complex or higher order hexaflexagons provide a much more difficult and interesting puzzle, and in fact have many surprising properties, many of which are presently unknown. While the construction of the more complex hexaflexagons is not explained here, they are well known in the literature, and the method of linking them together is essentially the same as that used for linking trihexaflexagons. I contend that my invention represents a new and extremely interesting combination of elements that is not at all obvious and deserves to be brought to the public since it represents a new, previously unknown form of great interest. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view of a strip of 10 equilateral triangles hinged together at adjacent edges. This strip will be used to describe the manufacture of a trihexaflexagon. FIG. 2 is a view of the strip being folded once. FIG. 3 is a view of the strip being folded a second time. FIG. 4 is a view of the strip being folded a final time. FIG. 5 shows how the 10th triangle is glued to the first triangle to form the completed trihexaflexagon made of exactly 9 equilateral triangles. FIG. 6 shows the beginning process of flexing the trihexaflexagon inside out by bringing the appropriate 3 alternate vertices of the hexaflexagon together. FIG. 7 shows the rest of the process of flexing the trihexaflexagon inside out by separating 3 vertices from the former center of the hexaflexagon. FIG. 8 shows the beginning of the process of linking one trihexaflexagon to another trihexaflexagon. FIG. 9 Shows the 2 linked trihexaflexagons and it is therefore the simplest possible slipagon. Each of the hexagonal loops of this structure can be flexed or folded to new positions with respect to one another. Each of the hexagonal loops of the structure depicted in FIG. 9 can also be slipped one against the other to new positions with respect to one another. FIG. 10 shows 4 trihexaflexagons linked together into a larger slipagon puzzle structure. FIG. 11 shows 4 trihexaflexagons linked into a loop to form a tetrahedron shaped slipagon puzzle. This puzzle can be flexed and or slipped into several different kinds of forms. FIG. 12 shows 4 trihexaflexagons linked into a loop to form a half of an octahedron shape. This puzzle can be gotten into many different geometric forms. FIG. 13 shows 6 trihexaflexagons linked into a loop that has the shape of a large hexagon. This slipagon puzzle is interesting since one of its forms is a large hexagon shape. FIG. 14 shows some of the other slipagon puzzles possible by means of the slipagon diagram technique where each dot respresent a hexaflexagon and each line connecting 2 dots represent the linkage between the two hexaflexagons represented by the dots. FIG. 14c shows a slipagon diagram in the shape of a cube. This structure has been built and it can be collapsed and partially flexed and opened back to its solid appearing form. FIG. 15 shows one method of manufacturing slipagons by means of a scored plastic strip of a self hinging plastic such as polypropylene. This material is particularly useful because it has a low coefficient of friction and makes slipping of the slipagon puzzles very easy. FIG. 16 shows how the 10th triangle may be removably joined to the first triangle by means of notched edges in the 10th triangle and slots in the 1st triangle. FIGS. 17 and 18 show a means of manufacture of the slipagons with rolls of tape and triangles that are dropped from a hopper onto the tape to form a strip of hingedly connected triangles. The hingedly connected triangles may then be cut into shorter strips and made into hexaflexagons that can be linked together to form slipagons. DESCRIPTION OF THE PREFERRED EMBODIMENTS The basic structrual elements of an amusement device formed in accordance with the present invention are hexaflexagons. FIG. 1 show a strip element 10 of ten equilateral triangle elements 11 with two end triangles 13, and 13 and the triangles are hingedly connected at adjacent edges 12 and each element 11 has an edge 14 that is not used as a hinge edge. Progress to FIG. 2 which shows the first fold 16 of one of the hinges 12. FIG. 2 shows two other hinges 12 which still need to be folded to make the trihexaflexagon element. FIG. 3 now shows that two folds 16 have been made. FIG. 4 shows the final fold 16 at a fold hinge 12 along with the other two folds 16 and 16 that have already been made. Finally FIG. 5 shows how the tenth end triangle element 13 is glued or fixedly attached by other means such as staples, weld or tape to the other end triangle element 13 to form the single ninth triangle element 19. The strucutre illustrate in FIG. 5 is the loop element 15 and is a trihexaflexagon. The loop element 15 is a twisted continuous loop of hingedly connected triangles where the twist is obtained by the way the hinges are folded before the ends of the strip are finally connected to form the continuous loop element 15. In order to build any hexaflexagon loop element it is necessary that enough twist exist in the loop to restrict the loop to a hexagon shape of 6 triangles on both sides when it is laid out flat. Higher order hexaflexagons, such as hexahexaflexagons made from longer strips of hingedly connected triangles, may also be used to build embodiments of my invention, and these kinds of higher loop elements must also satisfy the requirement of just the right amount of twist. For instance trihexaflexagons may be linked to hexahexaflexagons in many different ways, and hexahexaflexagons may be linked to other hexaflexagons to create puzzles of great difficulty and interest. FIG. 5 also shows three arrows leading away from three of the inner vertices of the trihexaflexagon loop element 15. These three vertices, indicated by the arrows in FIG. 5, are to be separated by first bringing the vertices 40 downward and together to form a radially pinched structure shown in FIG. 6. In FIG. 6 the three arrows are again shown and the three folded hinges 16 are also shown along with the vertices 40. Finally, FIG. 7 shows how the pinched structure in FIG. 6 has been opened out as indicated by the arrows in FIG. 6 and once again forms into a hexagonal shape but has acquired the three new folded hinges 16 whereas the previous folded hinges 16 in FIG. 6 have now become unfolded hinges 12 in FIG. 7. The trihexaflexagon loop element 15 can now be linked to another loop element 15 by inserting a strip 10 between one of the folds 16' in FIG. 8 and then folding the inserted strip 10 into a new loop elements 15 as explained previously for FIG. 5. FIG. 8 shows the first fold 16 being made upon the inserted strip 10. FIG. 9 shows the linked 2-loop structure 30. The two linked loop elements 15 and 15 have three folds 16 in one element 15 and three folds 16' in the other element 15. FIG. 9 also shows a slipagon diagram that represents 30 indicated by the node element 18 and the link line element 17. The node elements 18 represent loop elements and the link line elements 17 represent the way the loops are linked together. Other figures in this specification will also contain slipagon diagrams where appropriate to show how the elements 15 are linked at a glance and to provide a convenient means for discussion of methods of creating slipagons of many different kinds. FIG. 9 represent the simplest slipagon possible since it is formed on only two linked loop elements 15. FIG. 9 also shows two arrow indicia 20 fixedly marked on each of the two loop elements 15. This arrow indicia in FIG. 9 can be moved about by sliping or sliding the elements 15 by choosing one of the slide directions shown by the dotted arrows in FIG. 9. The arrow indicia in FIG. 9 can also be moved by flexing either one or both of the loop elements 15 as previously described by the description of the FIGS. 5, 6, and 7. A puzzle that is not too difficult is to get the arrow indicia back as shown in FIG. 9 after they are moved about with respect to one another by several slips and folds of the elements 15. Most slipagon puzzles can be either slipped or flexed or both. There may be several positions that a slipagon can be gotten into where either slipping or flexing becomes highly restricted. Getting the slipagon back to a normal position may then become extremely difficult. FIG. 10 is a chain slipagon puzzle 31 of four linked elements 15 and also shows the slipagon diagram for these four linked elements. The four arrows in FIG. 10 are indicia fixedly marked upon each of the four loop elements 15. These arrows can be moved about in many ways with respect to each other by flexing and or slipping the four loop elements 15 in FIG. 10. It is a pleasant puzzle figuring out how to restore the indicia to their original positions after moving them about at random by flexing and or slipping the four loop elements 15 in FIG. 10. FIG. 11 illustrates a loop puzzle 32 of four linked loop elements 15 and its slipagon diagram appears with it as four nodes connected by four line links to form a square. FIG. 11 shows the puzzle 32 as a regular tetrahedron but the puzzle 32 can assume many other forms by the operations of slipping and flexing as previously explained, and it can be exceedingly difficult to restore it to the tetrahedral form if it is gotten into a much different form. The three arrow indicia in FIG. 11 are to be complemented by a fourth arrow behind the middle arrow in FIG. 11 and on the opposite side of the puzzle 32. FIG. 12 is a perspective sketch of another loop puzzle 33 of four linked loop elements 15 along with its slipagon diagram. The slipagon diagram in FIG. 12 appears identical to the slipagon diagram in FIG. 11 but the puzzle 33 pictured in FIG. 12 is a distinctly different structure from the puzzle 32 shown in FIG. 11. The reason for this is that a different twist was given to the chain of four linked loop elements 15 before it was connected into a loop in the same manner that different twists may be given to moebius bands before connecting them into loops. The structure 33 illustrated in FIG. 12 is flexible, and the four arrow indicia may be mixed up and then restored. The puzzle 33 in FIG. 12 also has several forms different from the octahedral cap illustrated in FIG. 12, and some of these forms can be very difficult to return from, to the octahedral cap form. FIG. 13 is an overhead sketch view of a loop 34 of six linked loop elements 15 along with it's slipagon diagram. The six arrow indicia shown on the loop elements 15 of the loop puzzle 34 can be thoroughly mixed up and then restored but restoration can be very difficult. The puzzle 34 has a great many different forms. Loops of six linked loop elements 15 can be connected in several distinctly different ways not shown in any of the figures. FIG. 14 shows five different slipagon diagrams of other structures that can be made by linking the elements 15 as indicated by the diagrams a, b, c, d and e. The diagram a in FIG. 14 shows a basic branched slipagon structure. The diagram b in FIG. 14 shows the maximum number of branches possible at a single loop element 15 by linking the loop elements 15 to it. The diagram c in FIG. 14 shows a cubic method of linking the loop elements 15. The structure indicated by diagram c has been made by the present inventor and it can be collapsed and then opened back out to a three dimensional form in a new position. A deceptive puzzle could be made by eliminating one of the connecting link lines in diagram c thereby obtaining a structure that could be gotten into many positions that the puzzle of diagram c could not be gotten into and making it appear that the structure was still the same as that of diagram c. A slipagon puzzle with the slipagon diagram of FIG. 14 d was made by the present inventor. It has proven to be one of the most difficult slipagon puzzles so far discovered and it can be gotten into positions from which it may take a person hours to get back to some simple starting position. The structure of diagram e shows how many other slipagons can be made simply by designing diagrams and then checking out all possible ways of building the structures represented by a single diagram of linking and looping the loop elements 15, or by linking and looping more complicated hexaflexagon loop elements. FIG. 15 shows a perspective view of a portion of a self hinging plastic strip with triangle elements 11' and hinge elements 12'. Strips of this kind can easily be made with appropriate press rollers having dies for creating the hinge depressions as the plastic strip is pressed and rolled between the rollers. Several very good, well known, readily available, cheap, self hinging plastics exist and would work well to build the many embodiments of my invention. FIG. 16 shows a plan view of the two ends of a strip of ten equilateral triangle elements 11" with hinge elements 12" and end triangles 13'. The end triangles 13' in FIG. 16 illustrate how a self hinging plastic strip or other, suitable kind of strip of triangle elements 11" could be provided with notch elements 21' in one end element 13' to mate with notch elements 21 in the other end element 13' so as to provide a loop element 15, as previously described, that can be quickly disassembled and unlinked from other loop elements 15 and then reassembled and linked in new ways to other loop elements 15 to create many different kinds of slipagon structures. FIG. 17 shows a simple way to manufacture hinged strips of triangles by means of adhesive tape elements 22 and 22', rollers 23 and 23', press roller 24, hopper 26 containing triangles 11" in alternate orientatiions, and roller 27 under the hopper 26. The apparatus works by pulling the tape band 25 under the hopper 26 causing one edge of the triangle elements 11" to fall to the adhesive surface of the tape band 25 as can be seen in the partial frontal section of the hopper bottom in FIG. 18. After the tape band 25 passes under the hopper 26 and collects triangle elements 11" with hinge elements 12" it passes through tape roller 23' and press roller 24 and recieves another adhesive tape band 25' on its top from tape roll 22' completing the assembly of a long strip of hingedly connected equilateral triangles. The hinges are made extra strong from the contact of the adhesive surfaces of the two tape bands 25 and 25'. The width of the hinge elements 12" can be varied by changing the speed at which the tape band passes under the hopper 26. The finished strip of hingedly connected triangles may then be cut into smaller strips, which smaller strips are then used to build the puzzles described by the present invention. While certain specific embodiments of the present invention have been disclosed as typical, the invention is of course not limited to these particular forms, but rather is broadly applicable to all such variations as fall within the scope of the appended claims.

1a

FIELD OF THE INVENTION [0001] The present invention relates to a composition comprising prebiotic (prebiotic adjuvant) for decreasing inflammatory process by improving the homeostasis of non-specific immune defense parameters and of lymphocyte subpopulations. It also relates to the use of a prebiotic formulation in the manufature of a medicament or food or petfood composition for decreasing inflammatory process and/or abnormal activation of non-specific immune parameters, such as phagocytes. BACKGROUND OF THE INVENTION [0002] It is well known that prebiotics comprise carbohydrates and more specifically, oligosaccharides. Furthermore it is known that they have widely been used as functional food ingredients. They resist hydrolysis by enzymes of the human digestive tract, can reach the colon undegraded and provide a carbohydrate substance particulary suited to the growth of bifidobacteria Oligosaccharides may be produced from glucose, galactose, xylose, maltose, sucrose, lactose, starch, xylan, hemicellulose, inulin, gum or a mixture thereof. Purified commercially available products such as fructooligosaccharides contain greater than about 95% solids in the form of oligosaccharides. [0003] Fructooligosaccharides have been studied in humans mainly for functional claims related to the bioavailability of minerals, lipid metabolism and and regulation of bowel habits (Roberfroid, M. B. Delzenne, N. M. Annu Rev Nutr 1998;18:117-143). Little attention has been given to their effect on immunological functions, while indications for modifications of carcinogenesis and stimulation of gut-associated lymphoid tissue comes from animal studies (Pierre, F., et al. Cancer Res 1997;57:225-228) . [0004] Indeed, fructooligosaccharides, long (inulin) and short chain (oligofructose) are among the carbohydrates, which escape digestion in the upper gastro-intestinal tract. They are then fermented in the colon and selectively stimulate the growth of bifidobacteria. [0005] Human intestinal flora with its important metabolic activity is possibly associated with many health related functions such as maintenance of gut homeostasis, metabolism of xenobiotics and stimulation of gut immunity. It is influenced by disease, diet, stress and possibly ageing. The large intestine contains up to 10 12 bacteria/g faeces with about 10 3 different species from approximately 40-50 genera of bacteria. Most of them are obligate anaerobes with a large population, however, of facultative anaerobes. The main anaerobe species are Bacteroïdes , bifidobacteria, eubacteria, which make up to 99% of the total faecal flora, followed by clostridia, lactobacilli and gram positive cocci, enterococci, coliforms, methanogens and at much lower levels sulfate-reducing bacteria (Hill, M. J. Normal gut bacterial flora. 1995;3-17). [0006] Adult microflora characteristics are present from about 2 years of age. Adult gut microflora seems to be rather stable; although some changes have been reported with ageing, mainly low levels of bifidobacteria and Bacteroïdes (Hopkins, M. J., et al. Gut 2001;48:198-205). Gut flora can be divided into species that have beneficial effects, such as bifidobacteria, or harmful effects, such as Pseudonioinas aeruginosa, Protezus species, staphylococci, some clostridia and Veilonellae , and species that are intermediate in effect such as enterococci, Escherichia coli , Enterococci and Bacteroïdes. Bifidobacteria and lactobacilli have been reported to have beneficial effects on specific immune functions (Schiffrin, E. J., et al. J Dairy Sci 1995;78:491-497). [0007] With age it is generally reported that bifidobacteria are diminished, while Clostridim perfringens, Entercocci and Enterobacteriaceae are increased (Mitsuoka, T. Hayakawa, K. Zentralbl Bakteriol [Orig A] 1973;223:333-342). Bacterial overgrowth occurs more frequently in the elderly due to the high prevalence of atrophic gastritis and hypochlorhydria. Bacterial overgrowth seems to be free of clinical symptoms in healthy elderly, it may have some importance in frail elderly ≧75 year of age, and Clostridium difficile associated diarrhea is more frequent in the elderly in acute care or long-term care, in association with antibiotic treatment and possibly decreased immune response. Ageing is related with a loss in immune function and the existence of an interrelationship between nutrition and immune function has been recognized (Meydani, S. N. Status of Nutritional Immunology Studies: J Nutr Immunol 1994;2:93-97). [0008] Changes in immune response (remodeling of cytokine production and dysregulation of the immune functions) is associated with increased incidence of infections and mortality linked to infection. Nutritional interventions, mainly vitamin and mineral supplementation, can improve the immune response in frail elderly [Lesourd, B. M. Am J Clin Nutr 1997;66:478S-484S41]. [0009] The present invention aims to provide another composition able to limit the dysregulation of the immune function, and more particularly the abnormal activation of non-specific immune response such as the phagocytes and the monocyte macrophage cell system as well as preserve lymphocyte subpopulations in normal level of activation. SUMMARY OF THE INVENTION [0010] Consequently, in a first aspect the present invention provides a composition comprising at least one prebiotic for decreasing inflammatory process and/or abnormal activation of non-specific immune parameters. [0011] It may be particularly intended for decreasing abnormal activation of phagocytes, for example. [0012] It has been surprinsingly found that a prebiotic supplementation can induce decrease in inflammatory process, and particularly can induce changes in non-specific immunity, such as decreased phagocytic activity, as well as a decreased expression of interleukin-6 mRNA in peripheral blood monocytes. [0013] In a second aspect the invention provides the use of at least one prebiotic in the manufature of a medicament or a food or pet food composition for decreasing inflammatory process in a mammal. [0014] In a third aspect the invention provides use of at least one prebiotic in the manufature of a medicament or a food or pet food composition for decreasing abnormal activation of non-specific immune parameters in a mammal. [0015] In a forth aspect the invention provides a method of decreasing inflammatory process in a mammal, which comprises administering an effective amount of a prebiotic or composition comprising at least one prebiotic. [0016] In a fifth aspect the invention provides a method of decreasing abnormal activation of non-specific immune parameters in a mammal, which comprises administering an effective amount of a prebiotic or composition comprising at least one prebiotic. [0017] An advantage of the present invention is that it provides a decrease in inflammatory process, particularly a decrease expression of Interleukine-6 mRNA in peripheral blood mononuclear cells. [0018] Another advantage of the present invention is that it provides a decrease in phagocytic activity of granulocytes and monocytes, particularly in frail patient with chronic inflammatory situation. [0019] Yet another advantage of the present invention is that it may be used to improve the inflammatory situation in a mammal and thus reduce the risk of development of deleterious infections, by simple consumption of a food composition according to the present invention. It will be appreciated that intravenous or subcutaneous administration of a drug requires expertise, and compared to oral administration it is not as safe, convenient or acceptable to the patient. In the light of these concerns, the invention provides the clear advantage of a nutritional and/or therapeutic product which may be administered orally. DETAILED DESCRIPTION [0020] According to a first aspect, the composition preferably comprises at least one prebiotic or a prebiotic mixture. [0021] Preferably, the prebiotic comprises an oligosachharide produced from glucose, galactose, xylose, maltose, sucrose, lactose, starch, xylan, hemicellulose, inulin, gum (acacia gum, for example) or a mixture thereof. More preferably the oligosaccharide comprises fructooligosaccharide (FOS). Most preferably the prebiotic comprises a mixture of fructooligosaccharide and inulin. Preferably this mixture comprises PREBIO1® or a mixture of commercially available RAFTILOSE® and RAFTILINE®. [0022] Preferably, the prebiotic comprises about 50% to about 95% FOS. More preferably it comprises about 60% to about 80% FOS. Most preferably it comprises about 70% FOS. [0023] Preferably, the prebiotic comprises about 10% to about 50% inulin. More preferably it comprises about 20% to about 40% inulin. Most preferably it comprises about 30% inulin. [0024] The prebiotic may comprise a mixture of fructooligosaccharides and inulin in the amounts by weight of 70% fructooligosaccharides and 30% inulin. [0025] Preferably, the composition comprises a probiotic in addition to the prebiotic. The probiotic may be Bifidobacterium bifidum or Streptococcus thermophilus , for example. Preferably the Bifidobacterium bifidum is Bifidobacterium lactis. [0026] In one embodiment, the composition may be a complete and nutritionally balanced food or pet food. It can also be a dietary supplement, for example. It is preferably adressed to elderly human or elderly pet, or critically ill patients with chronic inflammation. [0027] Accordingly, a nutritionally complete pet food can be prepared. The nutritionally complete pet food may be in any suitable form; for example in dried form, semi-moist form or wet form; it may be a chilled or shelf stable pet food product. These pet foods may be produced as is conventional. Preferably, the prebiotic is provided in the form of plant material, which contains the prebiotic. Suitable plant materials include asparagus, artichokes, onions, wheat, yacon or chicory, or residues of these plant materials. Alternatively, the prebiotic may be provided as an inulin extract or its hydrolysis products commonly known as fructooligosaccharides, galacto-oligosaccarides, xylo-oligosaccharides or oligo derivatives of starch. Extracts from chicory are particularly suitable. The maximum level of prebiotic in the pet food is preferably about 20% by weight; especially about 10% by weight. For example, the prebiotic may comprise about 0.1% to about 5% by weight of the pet food. For pet foods which use chicory as the prebiotic, the chicory may be included to comprise about 0.5% to about 10% by weight of the feed mixture; more preferably about 1% to about 5% by weight. [0028] Apart from the prebiotic according to the invention, these pet foods may include any one or more of a carbohydrate source, a protein source and lipid source. [0029] Any suitable carbohydrate source may be used. Preferably the carbohydrate source is provided in the form of grains, flours and starches. For example, the carbohydrate source may be rice, barley, sorghum, millet, oat, corn meal or wheat flour. Simple sugars such as sucrose, glucose and corn syrups may also be used. The amount of carbohydrate provided by the carbohydrate source may be selected as desired. For example, the pet food may contain up to about 60% by weight of carbohydrate. [0030] Suitable protein sources may be selected from any suitable animal or vegetable protein source; for example muscular or skeletal meat, meat and bone meal, poultry meal, fish meal, milk proteins, corn gluten, wheat gluten, soy flour, soy protein concentrates, soy protein isolates, egg proteins, whey, casein, gluten, and the like. For elderly animals, it is preferred for the protein source to contain a high quality animal protein. The amount of protein provided by the protein source may be selected as desired. For example, the pet food may contain about 12% to about 70% by weight of protein on a dry basis. [0031] The pet food may contain a fat source. Any suitable fat source may be used both animal fats and vegetable fats. Preferably the fat source is an animal fat source such as tallow. Vegetable oils such as corn oil, sunflower oil, safflower oil, rape seed oil, soy bean oil, olive oil and other oils rich in monounsaturated and polyunsaturated fatty acids, may also be used. In addition to essential fatty acids (linoleic and alpha-linoleic acid) the fat source may include long chain fatty acids. Suitable long chain fatty acids include, gamma linoleic acid, stearidonic acid, arachidonic acid, eicosapentanoic acid, and docosahexanoic acid. Fish oils are a suitable source of eicosapentanoic acids and docosahexanoic acid. Borage oil, blackcurrent seed oil and evening primrose oil are suitable sources of gamma linoleic acid. Rapeseed oil, soybean oil, linseed oil and walnut oil are suitable sources of alpha-linoleic acid. Safflower oils, sunflower oils, corn oils and soybean oils are suitable sources of linoleic acid. Olive oil, rapeseed oil (canola) high oleic sunflower and safflower, peanut oil, rice bran oil are suitable sources of monounsaturated fatty acids. The amount of fat provided by the fat source may be selected as desired. For example, the pet food may contain about 5% to about 40% by weight of fat on a dry basis. Preferably, the pet food has a relatively reduced amount of fat. [0032] The pet food may contain other active agents such as long chain fatty acids. Suitable long chain fatty acids include alpha-linoleic acid, gamma linoleic acid, linoleic acid, eicosapentanoic acid, and docosahexanoic acid. Fish oils are a suitable source of eicosapentanoic acids and docosahexanoic acid. Borage oil, blackcurrent seed oil and evening primrose oil are suitable sources of gamma linoleic acid. Safflower oils, sunflower oils, corn oils and soybean oils are suitable sources of linoleic acid. [0033] The choice of the carbohydrate, protein and lipid sources is not critical and will be selected based upon nutritional needs of the animal, palatability considerations, and the type of product produced. Further, various other ingredients, for example, sugar, salt, spices, seasonings, vitamins, minerals, flavoring agents, gums, and probiotic micro-organisms may also be incorporated into the pet food as desired [0034] A probiotic microorganism may also be added. It may be selected from one or more microorganisms suitable for animal consumption and which is able to improve the microbial balance in the intestine. Examples of suitable probiotic micro-organisms include yeast such as Saccharomyces, Debaromyces, Candida, Pichia and Torulopsis , moulds such as Aspergillus, Rhizopus, Mucor , and Penicillim and Torulopsis and bacteria such as the genera Bifidobacterium, Bacteroides, Clostridium, Fusobacterium, Melissococcus, Propionibacterium, Streptococcus, Enterococcus, Lactococcus, Staphylococcus, Peptostrepococcus, Bacillus, Pediococcus, Micrococcus, Leuconostoc, Weissella, Aerococcus, Oenococcus and Lactobacillus . The probiotic micro-organisms may be in powdered, dried form; especially in spore form for micro-organisms which form spores. Further, if desired, the probiotic micro-organism may be encapsulated to further increase the probability of survival; for example in a sugar matrix, fat matrix or polysaccharide matrix. If a probiotic micro-organism is used, the pet food preferably contains about 10 4 to about 10 10 cells of the probiotic micro-organism per gram of the pet food; more preferably about 10 6 to about 10 8 cells of the probiotic micro-organism per gram. The pet food may contain about 0.5% to about 20% by weight of the mixture of the probiotic micro-organism; preferably about 1% to about 6% by weight; for example about 3% to about 6% by weight. [0035] For elderly pets, the pet food preferably contains proportionally less fat than pet foods for younger pets. Further, the starch sources may include one or more of oat, rice, barley, wheat and corn. [0036] For dried pet foods a suitable process is extension cooking, although baking and other suitable processes may be used. When extrusion cooked, the dried pet food is usually provided in the form of a kibble. If a prebiotic is used, the prebiotic may be admixed with the other ingredients of the dried pet food prior to processing. A suitable process is described in European patent application No 0850569;. If a probiotic micro-organism is used, the organism is best coated onto or filled into the dried pet food. A suitable process is described in European patent application No 0862863. [0037] For wet pet foods, the processes described in U.S. Pat. Nos. 4,781,939 and 5,132,137 may be used to produce simulated meat products. Other procedures for producing chunk type products may also be used; for example cooking in a steam oven. Alternatively, loaf type products may be produced by emulsifying a suitable meat material to produce a meat emulsion, adding a suitable gelling agent, and heating the meat emulsion prior to filling into cans or other containers. [0038] In another embodiment, a food composition for human consumption is prepared. This composition may be a nutritional complete formula, a dairy product, a chilled or shelf stable beverage, soup, a dietary supplement, a meal replacement, and a nutritional bar or a confectionery. [0039] Apart from the prebiotic according to the invention, the nutritional formula may comprise a source of protein. Dietary proteins are preferably used as a source of protein. The dietary proteins may be any suitable dietary protein; for example animal proteins (such as milk proteins, meat proteins and egg proteins); vegetable proteins (such as soy protein, wheat protein, rice protein, and pea protein); mixtures of free amino acids; or combinations thereof. Milk proteins such as casein, whey proteins and soy proteins are particularly preferred. The composition may also contain a source of carbohydrates and a source of fat. [0040] If the nutritional formula includes a fat source, the fat source preferably provides about 5% to about 55% of the energy of the nutritional formula; for example about 20% to about 50% of the energy. The lipids making up the fat source may be any suitable fat or fat mixtures. Vegetable fats are particularly suitable; for example soy oil, palm oil, coconut oil, safflower oil, sunflower oil, corn oil, canola oil, lecithins, and the like. Animal fats such as milk fats may also be added if desired. [0041] A source of carbohydrate may be added to the nutritional formula. It preferably provides about 40% to about 80% of the energy of the nutritional composition. Any suitable carbohydrates may be used, for example sucrose, lactose, glucose, fructose, corn syrup solids, and maltodextrins, and mixtures thereof. Dietary fibre may also be added if desired. If used, it preferably comprises up to about 5% of the energy of the nutritional formula. The dietary fibre may be from any suitable origin, including for example soy, pea, oat, pectin, guar gum, gum arabic, and fructooligosaccharides. Suitable vitamins and minerals may be included in the nutritional formula in an amount to meet the appropriate guidelines. [0042] One or more food grade emulsifiers may be incorporated into the nutritional formula if desired; for example diacetyl tartaric acid esters of mono- and di-glycerides, lecithin and mono- and di-glycerides. Similarly suitable salts and stabilisers may be included. [0043] The nutritional formula is preferably enterally administrable; for example in the form of a powder, tablet, capsule, a liquid concentrate, solid product or a ready-to-drink beverage. If it is desired to produce a powdered nutritional formula, the homogenised mixture is transferred to a suitable drying apparatus such as a spray drier or freeze drier and converted to powder. [0044] In another embodiment, a nutritional composition comprises a milk based cereal together with a prebiotic formulation. Preferably the milk based cereal is an infant cereal which acts as a carrier for the prebiotic formulation. [0045] In another embodiment, a usual food product may be enriched with at least one prebiotic according to the present invention. For example, a fermented milk, a yoghurt, a fresh cheese, a renneted milk, article of confectionery, for example a sweet or sweetened beverage, a confectionery bar, breakfast cereal flakes or bars, drinks, milk powders, soy-based products, non-milk fermented products or nutritional supplements for clinical nutrition. Then, the amount of the composition added is preferably at least about 0.01% by weight. [0046] The following examples are given by way of illustration only and in no way should be construed as limiting the subject matter of the present application. Percentages and parts are by weight unless otherwise indicated. The example are preceeded by a brief description of the figures. [0047] [0047]FIG. 1: Effect of feeding 8 g of short-chain fructooligosaccharides (FOS) on viable counts of bifidobacteria in fresh faecal samples of nursing home elderly. Time points were before (2), during (3), and after (4) period of 3 weeks of FOS intake. (A) Individual values. (B) Box plots. Boxes indicate 25 th and 75 th percentiles, solid lines inside box indicate median values, and t-shapes 5 th and 95 th percentiles; solid dot indicates outlying value. [0048] [0048]FIG. 2:: Effect of fructooligosaccharides (FOS) on bifidobacteria in adults and elderly. Reference 24 (Bouhnik Y et al. J Nutr 1999; 129:113) dose response from 2.5 to 20 g FOS/day in 18-47 year old adults; Reference 25 (Menne E et al. J Nutr 2000;130:1197) response to 8 g FOS/day in 20-50 year old adults; Reference 26 (Gibson G R J Nutr 1999;129:1438S) response to 15 gFOS/day in young adults; Reference 27 (Kruse H P et al. Brit J Nutr 1999;82:375) response to inulin up to 34 g/day in 26-53 year old adults; Reference 28 (Kleessen B et al. Am J Clin Nutr 1997; 65:1397) response to 20 g FOS/day in elderly constipated subjects aged 68-89 years; Present study: resposne to 8 g FOS/day in nursing home subjects aged 77-91 years. [0049] [0049]FIG. 3: Differences in IL-6 mRNA expression in peripheral blood mononuclear cells (PBMC) of elderly supplemented with FOS. IL-6 mRNA expression in PBMC was measured by reverse transcription-polymerase chain reaction (RT-PCR). Estimation of quantitative changes were done by scanning band intensity using NIH-image program and calculated as density ratio of IL-6 mRNA to β-actin mRNA in percent. Time points were before (2), during (3), and after (4) period of 3 weeks of FOS intake. (A) Representative image of individual changes from ethidium bromide stained gels. (B) Quantitative estimation of IL-6 mRNA expression: Changes in IL6-mRNA during FOS intakes are significantly different from before FOS intakes (p=0.018). EXAMPLE 1 Effects of Oligosaccharide on the Faecal Flora And Non-Specific Immune System in Elderly People [0050] Materials and Methods [0051] Study Design [0052] The study was a pretest/posttest study of 19 elderly nursing home patients (see study scheme). [0053] Measure of body weight and sample collection for stool, blood and urine were at time point 1 (pretest or at the beginning of the wash out period), 2 (before prebiotic intake), 3 (during prebiotic intake) and 4 (after follow up period) [0054] During the whole study, intake of fermented dairy products were restricted and fructooligosaccharides containing food (onion, leek, chicory roots) were limited. [0055] Subjects [0056] Nineteen elderly subjects in a nursing home were recruited for the study. Subjects fulfilling one or more of the following criteria were excluded from participation in the study: [0057] Antibiotic treatment in the past month [0058] Chronic intestinal disorder [0059] Particular dietary regimen (i.e. vegetarian) [0060] Diagnosis of gastrointestinal cancer [0061] Presence of flatulence [0062] Approval was obtained from the institutional ethical committee. Written informed consent was obtained from all subjects. The study was carried out at a local nursing home, Le Mont-Pelerin, Switzerland. [0063] Nutritional Status [0064] At entrance into study nutritional status was evaluated by the Mini Nutritional Assessemnt (MNA) test which includes the following items: anthropometric measurements (calf and arm circumference, height, weight and weight loss), general assessments (lifestyle, medications, mobility), dietary questionnaires (number of meals, fluid and food intakes, autonomy of feeding) and subjective assessments (self perception for health and nutrition.) [Guigoz, Y., et al. Nutr Rev 1996;54:S59-565]. MNA classified the elderly nutritional status using a 30 point scale: MNA≧24=wellnourished, MNA 17-23.5=at risk of malnutrition and MNA<17=malnourished. [0065] Prebiotic Supplementation [0066] Eight gram of short chain fructooligosaccharides (FOS) per day was administered as follows: twice a day 4 g FOS powder (Actilight 950P, Bëghin-Meiji industries, Neuilly-sur-Seine, France) were incorporated in a dish at the time of the meal by the nurses. For estimation of compliance, the daily consumption of the supplement was recorded by the nurses on a daily record sheet. [0067] Microbial Investigations [0068] The endogenous populations of Lactobacilli, Bacteroïdes, Enterobacteriaceae, Enterococci, Bifidobacteria and Clostridium peifringens were counted. [0069] Stool samples were collected at day 0, 21, 42 and 63 from each subject. The stool samples were immediately (within 30 minutes) placed in an anaerobic jar and kept at 4° C. until analysis (a maximum of 6 hours). Hundred fold serial dilutions were performed in pre-reduced Ringer solution containing 0.5% of cystein, from −2 to −8. Petri dishes of various media were inoculated and incubated for 48 hr at 37° C. in anaerobic atmosphere using Anaerocult A (Merck, Darmstadt, Germany), except for Enterococci and Enterobacteriacea incubated for 24 hr at 37° C. in aerobic atmosphere. Bacteria were detected on selective or half-selective media as follows: Enterobacteriacea on Drigalski medium (Sanofi Diagnostics Pasteur, France), Bifidobacteria on Eugon Tomato medium (Wadsworth Anaerobic Bacteriology Manual, V. Suter, D. Citron and S. Finegold Third edition), Lactobacilli in MRS (Difco, MI. USA) with antibiotics (Phosphomycine (79.5 mg/l)+Sulfamethoxazole (0.93 mg/l)+Trimethoprime (5 mg/l)), Clostridium perfringens on NN agar (Lowbury and Lilly, 1995), Bacteroïdes on Schaedler Neo-Vanco medium (BioMérieux, Marcy-I'Etoile, France), and Enterococci on Azide agar (Difco). [0070] After incubation, the colonies were counted and further identified if necessary. Lactobacilli and Bifidobacteria strains were identified by microscopy, and biochemically using the API gallery system (BioMérieux), API 50 CHL gallery for lactobacilli, and API ID 32A gallery for Bifidobacteria respectively. Bacterial counts are expressed as log 10 colony-forming units (CFUs) per gram of fresh faecal sample, with a detection limit at 3.30 cfu/g. [0071] Faecal PH [0072] Faecal pH was measured just after emission by the nurse at three different points in crude faeces with a microelectrode (Orion). The mean pH was calculated for each time point. [0073] Blood Sampling [0074] Fasting blood samples were drawn before the start of the study (4 ml) and at day 0, 21, 42 and 63 (23 ml) from each subject. Blood was taken in the morning (before 10 a.m.) after an overnight fast. Samples collected in vacutainer tubes. 13 ml were collected in heparinized tube, and 10 ml were allowed to clot at room temperature for 30-60 minutes. Serum samples were kept frozen at −70° C. until analysis. Heparinized blood was used for the functional immune parameters (phagocytosis, see below) and hematology. [0075] Immunological Analysis [0076] Populations of peripheral blood mononuclear cells and their phagocytic activity were analyzed in fresh samples of heparinized blood using Simulset and Pagotest (Becton Dickinson, Basel, Switzerland). [0077] Analysis of interleukin-6 mRNA expression by PCR: Analysis of mRNA expression in the peripheral blood mononuclear cells was evaluated by PCR according to the method described by Delneste, Y., et al. ( Nutr Rev 1998; 56:S93-S98). Primer sequences were: 5′-CTGCAGGAACTGGATCAGGACTTTTGTACT-3′ and 5′-GCCTTCGGTCCAGTTGCCTTCTCCCTGGGG-3′ for interleukin-6 (IL-6) and 5′CGTTTCCCGCTCGGCCGTGGTGGTGAAGC-3′ and 5′-GGCGACGAGGCCCAGAGCAAGAGAGGCATC-3′ for β-actin. [0078] Biochemical Measurements [0079] Serum albumin, transthyretin (prealbumin), C-reactive protein, and a, acid glycoprotein concentrations were analyzed by immuno-nephelometry with a Behring Nephelometer (methods and reagents from Behring, Marburg, Germany). Serum folate and vitamin B 12 (cobalamin) concentrations were analyzed by radioimmunoassay (Dual Count, Diagnostic Product Corporation, Los Angeles, Calif., USA). [0080] Statistical Analysis [0081] One sample t-test or Wilcoxon signed-rank test were computed on the mean differences to evaluate the statistical significance at 0.05% level for the main hypothesis: Is there an effect of prebiotics on the different parameters measured? Further one sample t-test were computed on-the mean differences to evaluate the statistical significance at 0.025% level (correction for the loss of degree of freedom) for the two question related to the design of the study, which included pre and post test periods: Is there an effect of stopping fermented milk (=wash-out period) on the different parameters measured? Is there an effect of stopping prebiotics (=follow-up period) on the different parameters measured? All statistical analysis were done using the NCSS 6.0.22 statistical software. [0082] Results [0083] Subjects [0084] The 19 subjects, 4 men and 15 women, had a mean age of 85±6.0 years (77-97 year old). Women were significantly lighter than men. Subjects' characteristics at start of study are given in table 1. TABLE 1 Subjects characteristics 95% confidence Range mean interval min Max Men n = 4 Age [year] 84 5.7 77 91 Body weight [kg] 72.1 13.8 60.4 92.4 BMI [kg/mE2] 27.5 5.5 23.4 35.7 MNA score [pts] 27.0 2.9 24.0 30.0 Albumin [g/L] 36.3 1.7 31.1 40.9 Transthyretin [g/L] 0.23 0.04 0.17 0.28 α1-acid glycoprotein [g/L] 0.98 0.16 0.82 1.20 C-reactive protein [mg/L] 15 12 3 28 Cholesterol [mmol/l] 4.23 1.26 2.92 6.00 Triglycerides [mmol/l] 1.39 0.59 0.65 1.99 Phospholipids [mmol/l] 2.10 0.51 1.52 2.78 Women n = 15 Age [year] 85 3.1 77 97 Body weight [kg] 57.5 5.8 39.7 80.0 BMI [kg/mE2] 25.7 1.7 17.5 30.7 MNA score [pts] 23.9 1.4 17.0 28.0 Albumin [g/L] 36.8 1.7 31.1 42.7 Transthyretin [g/L] 0.22 0.02 0.15 0.23 α1-acid glycoprotein [g/L] 0.85 0.10 0.56 1.19 C-reactive protein [mg/L] 5 2 1 15 Cholesterol [mmol/l] 5.72 0.56 3.81 7.69 Triglycerides [mmol/l] 1.51 0.23 1.11 2.55 Phospholipids [mmol/l] 2.55 0.18 2.03 3.21 [0085] Only one subject was malnourished, the 7 women at risk of malnutrition were in the upper-score range 21.5-23, and the mean MNA score was in the wellnourished range: 24.6±3.0 points. [0086] Serum albumin (normal range 35-55 g/L) and transthyretin (prealbumin; normal range 0.16-0.40) were in the lower normal range, while the acute phase proteins, α1-acid glycoprotein (normal range 0.5-1.3) and C-reactive protein (normal values <10 mg/L and abnormal values for elderly >20 mg/L) indicated no presence of inflammatory process, except for 2 men (elevated C-reactive protein levels) and 2 women (low albumin levels with normal transthyretin and borderline C-reactive protein). These results suggest a group of elderly who were still wellnourished but rather frail. [0087] Bacteriological Analyses and Faecal PH [0088] Bacterial counts of bifidobacteria were increased by a mean of 2.8±0.57 log 10 CFU during the 3 weeks of FOS supplementation (p<0.001), but Bacteroïdes counts were also increased p< 0.032) (see tables 2a & 2b and FIG. 1). TABLE 2a Effect of FOS administration on faecal flora and pH Pretest Before During After administration of fructooligosaccharides (8 g/day) Faecal mean 95% CI mean 95% CI mean 95% CI mean 95% CI variable log 10 CFU/g faeces Enterobacteriaceae 7.7 0.6 7.2 0.8 7.1 0.9 8.0 0.7 Enterococci 6.1 0.8 5.7 0.9 5.4 0.8 6.2 0.9 Bifidobacteria 6.0 1.1 5.6 1.2 8.4 1.0 7.3 1.2 Lactobacilli 5.1 0.6 5.1 0.6 5.7 1.0 5.1 0.7 Bacteroides 8.8 0.3 8.6 0.3 9.3 0.3 9.8 0.3 Clostridium 3.5 0.2 3.7 0.5 3.7 0.5 3.5 0.4 perfringens pH pH 7.1 0.2 6.9 0.2 7.0 0.2 7.0 0.2 [0089] Bacterial counts for Enterobacteriaceae , Enterococci, and lactobacilli were not significantly affected by suppression of fermented milk products and/or the ingestion of fructooligosaccharides (FOS). While for bifidobacteria the effect seems to be a specific response to the ingestion of FOS, it resulted mainly in increased counts of bifidobacteria for subjects showing a log 10 CFU lower than 7 before starting FOS. Suppression of FOS supplementation significantly decreased counts of bifidobacteria by 1.1±0.39 log 10 CFU, but not to start level (tables 2a & 2b and FIG. 1). In FIG. 2 changes in bifidobacteria obtained in this study are compared to previous studies indicating that elderly are at least as sensitive to the effect of FOS as younger adults. Neither the suppression of fermented milk products nor the ingestion of FOS changed faecal pH (table 2a). [0090] Non-Specific Immunity [0091] Ingestion of FOS resulted in a significant increased percentage of peripheral T lymphocytes as well as the lymphocyte subsets, CD4+, CD8+ T cells (tables 3a & 3b). Total number of white blood cells, activated T lymphocytes and natural killer (NK) cells were not affected by the ingestion of FOS (tables 3a & 3b). TABLE 3a Peripheral immunological parameters: lymphocyte subpopulations Pretest Before During After Administration of fructooligosaccharides (8 g/day) Variable Units Mean 95% CI Mean 95% CI Mean 95% CI Mean 95% CI White blood cells # 10 −3 nd 4.9 0.6 5.3 0.7 5.8 0.7 T lymphocytes % 65.7 4.8 64.0 4.3 68.7 5.4 66.9 4.1 B lymphocytes %  7.7 1.5 8.3 1.7 8.5 1.4 8.1 1.5 CD 4 + cells % 40.8 4.4 41.7 4.1 47.3 4.5 45.1 4.0 CD 8 + cells % 35.3 4.4 33.2 4.5 38.3 4.7 36.8 4.7 Activated T % 15.0 3.8 15.7 4.1 15.6 4.7 18.6 5.3 lymphocytes NK cells % 22.0 3.9 21.9 3.4 24.8 3.4 21.3 3.3 [0092] [0092] TABLE 3b-c-d Changes in peripheral immunological parameters Data given are the mean difference ± standard error of the mean (sem) after each period of 3 weeks No fermented milk Products (Wash-out period) n = 13-19 units Mean Δ 2 ±sem p value 5 White blood cells # 10 −3 — — — T lymphocytes % −1.7 0.97 0.157 B lymphocytes % 0.4 0.34 0.298 CD 4 + cells % 0.8 0.91 0.397 CD 8 + cells % −2.1 0.82 0.019 Activated T lymphocytes % 0.7 0.72 0.353 NK cells % 0.05 1.15 0.964 FOS 1 8 g/day (Prebiotic intake period) n = 13-19 units Mean Δ 3 ±sem p value 5 White blood cells # 10 −3 0.347 0.286 0.243 T lymphocytes % 4.6 1.49 0.006 B lymphocytes % 0.3 0.44 0.562 CD 4 + cells % 5.7 1.34 <0.001 CD 8 + cells % 5.0 0.99 <0.001 Activated T lymphocytes % −0.1 1.00 0.918 NK cells % 2.9 1.48 0.066 No FOS (Follow-up period) n = 13-19 units Mean Δ 4 ±sem p value 5 White blood cells #10 −3 0.495 0.362 0.326 T lymphocytes % −1.8 1.42 0.225 B lymphocytes % −0.4 0.46 0.434 CD 4 + cells % −2.3 1.38 0.111 CD 8 + cells % −1.4 1.14 0.227 Activated T lymphocytes % 3.0 0.93 0.005 NK cells % −3.6 1.40 0.020 [0093] Phagocytic activity of granulocytes and monocytes were significantly decreased by the ingestion of FOS: Phagocytic activity expressed as median fluorescent intensity changed for granulocytes from 130±10 to 52±2 (p<0.001) and for monocytes from 75±5 to 26±2 (p<0.001). [0094] This possible decrease in inflammatory process is also suggested by the significant decrease in Interleukin-6 mRNA levels in peripheral blood mononuclear cells after ingestion of FOS (FIG. 3). [0095] Vitamin B 12 and Folate Status [0096] Neither vitamin B 12 nor folate serum levels were influenced by the supplementation in FOS: Serum vitamin B 12 were at 271±143 ng/L before supplementation and at 289±160 ng/L during supplementation. Three subjects, however, were deficient in vitamin B 12 . Two subjects returned to normal status during the study while the other remained deficient throughout study. Serum folate levels were at 5.9±2.0 ug/L before supplementation and at 5.7±1.9 ug/L during supplementation. [0097] Our results strongly support the bifidogenic effects of fructooligosaccharides in elderly subjects with a 2 log increase in bifidobacteria counts since our frail elderly subjects showed low counts at the beginning of the study. A diminution in inflammatory process is suggested by the decreased expression of IL-6 mRNA in peripheral blood monocytes. Indeed, the present study confirms the positive effect of FOS supplementation on bifidobacteria observed in adults and elderly (FIG. 2), indicating that elderly respond to prebiotic (FOS) intake by an increase in bifidobacteria like younger adults or even better if the bifidobacteria counts are low. Further 8 g of FOS or less seems to be sufficient to achieve a maximal effect on bifidobacteria counts. While from different studies a dose response seems to be present, single studies indicate that above a threshold of 4-5 g/day a maximal response is obtained and the increase in bifidobacteria seems to be more dependent of the initial number (FIGS. 1 and 2). Often FOS added to the diet increased the levels of bifidobacteria at the expense of potentially harmful bacteria, clostridia and Bacteroïdes mainly. But we observed a significant increase in Bacteroïdes throughout the study (tables 2a & 2b). [0098] We observed an important decrease in phagocytic activity. This decrease in phagocytic activity could be a reflection of decreased activation of macrophages linked to a possible reduction in pathogenic bacteria, and thus suggesting a diminution in inflammation due to lower endotoxin load. Surprisingly, however, this possible decrease in inflammatory process is suggested by the decrease in Interleukin-6 mRNA levels in peripheral blood mononuclear cells (FIG. 3). EXAMPLE 2 Food Supplement [0099] A food supplement was prepared by mixing or blending fructooligosaccharide with inulin in the proportions by weight of about 70% fructooligosaccharide to about 30% inulin. The resulting prebiotic mixture may be added or blended with any suitable carrier, for example a fermented milk, a yogurt, a fresh cheese, a renneted milk, a confectionery bar, breakfast cereal flakes or bars, a drink, milk powder, soy-based product, non-milk fermented product or a nutritional supplement for clinical nutrition. EXAMPLE 3 Dry Pet Food [0100] A feed mixture is made up of about 58% by weight of corn, about 5.5% by weight of corn gluten, about 22% by weight of chicken meal, 2,5% dried chicory, 1% carnitine, salts, vitamins and minerals making up the remainder. [0101] The fed mixture is fed into a preconditioner and moistened. The moistened feed is then fed into an extruder-cooker and gelatinised. The gelatinised matrix leaving the extruder is forced through a die and extruded. The extrudate is cut into pieces suitable for feeding to dogs, dried at about 110° C. for about 20 minutes, and cooled to form pellets. [0102] This dry dog food is particularly intended for decreasing inflammatory process and/or abnormal activation of non specific immune parameters, such as phagocytes. EXAMPLE 4 Wet Canned Pet Food [0103] A mixture is prepared from 56% of poultry carcass, pig lungs and pig liver (ground), 13% of fish, 16% of wheat flour, 2% of plasma, 10.8% of water, 2.2% of dyes, 1% of semi refined kappa carrageenan, inorganic salts and 9% oil rich in monounsaturated fatty acids (olive oil) and 3% chicory. This mixture is emulsified at 12° C. and extruded in the form of a pudding which is then cooked at a temperature of 90° C. It is cooled to 30° C. and cut in chunks. [0104] 30% of these chunks (having a water content of 58%) is incorporated in a base prepared from 23% of poultry carcass, 1% of guar gum, 1% of dye and aroma and 75% of water. Tinplate cans are then filled and sterilized at 127° C. for 60 min.

1a

FIELD OF INVENTION [0001] This invention relates generally to invasive medical devices and more specifically to fiber-optic systems for imaging the lumen of blood vessels and for measuring physiological variables such as blood pressure. BACKGROUND [0002] The functional severity of a stenotic lesion in an artery can be assessed by measuring the pressure gradient across the lesion. Intravascular pressure measurement, particularly in the coronary arteries, has gained widespread acceptance as a tool for guiding catheter-based interventional procedures. Angioplasty or stenting of lesions in coronary arteries can be avoided if the fractional flow reserve (Mt), defined as the ratio of the blood pressures measured distal to and proximal to a lesion after injection of a vasodilating drug, exceeds a certain clinically defined threshold. [0003] Various devices have been developed for sensing arterial pressure at the tip of miniature catheters during medical diagnostic and interventional procedures. The most widely used device of this type, often referred to as a “pressure wire,” employs an electronic pressure transducer embedded in the side of a long metallic tube through which electrically conducting wires pass to a connector at the proximal end. Typically, the transducer is mounted at a distance 1-2 cm proximal to a spring at the distal tip of the tube. The operator navigates the tube through the artery manually until the transducer reaches the desired location for local pressure measurement. [0004] One drawback of electronic pressure measurement systems is the relatively large minimum diameter of the pressure wire, which is determined by the size of the transducer, wires, and wire attachment assembly. The diameter of a pressure wire is critically important, because it must pass through narrow stenoses in blood vessels without significantly increasing the pressure gradient across the stenosis or preventing passage of the wire through the stenosis. This is especially significant because diseased arteries that are candidates for angioplasty, for example, can have lumen diameters smaller than 1 mm. [0005] A second drawback of electronic pressure monitoring systems is their susceptibility to electrical interference and calibration drift. Careful sealing of the wires and transducer to avoid moisture intrusion and shielding of the wires against electromagnetic interference are required to minimize environmental disturbances. [0006] Frequently, acquisition of intravascular images and measurement of intravascular pressures during a single medical procedure is desirable. However in such an application, when intended to be used with imaging catheters, electronic pressure wires, because of their wire connections, are difficult to integrate with intravascular imaging catheters. [0007] The present invention addresses these issues. SUMMARY OF THE INVENTION [0008] The present invention relates to a method and apparatus for providing cost-effective pressure monitoring capabilities to an intravascular optical coherence tomography (OCT) system. The combined system permits convenient use of both modalities from a single system console in which processing, catheter control, and parameter and image display are controlled by software executing on the same computer. [0009] The invention provides, in part, an OCT system with integrated pressure measurement. The OCT system in one embodiment includes: an interferometer, an acquisition and display system, and a probe including a pressure sensor. The interferometer in one embodiment includes: a wavelength swept laser; a source arm in optical communication with the wavelength swept laser; a reference arm in optical communication with a reference reflector; a first photodetector having a signal output; a detector arm in optical communication with the first photodetector; a probe interface; and a sample arm in optical communication with a first optical connector of the probe interface. The acquisition and display system in one embodiment includes: an analog to digital converter having a signal input in electrical communication with the first photodetector signal output and a signal output; a processor system in electrical communication with the analog to digital converter signal output; and a display in electrical communication with the processor system. The probe in one embodiment is configured for optical connection to the first optical connector of the probe interface, and the pressure transducer includes an optical pressure transducer. [0010] In some embodiments of the OCT system, the analog to digital converter further includes a sample clock input and a trigger input, and the OCT system further includes: a power splitter having a first arm in optical communication with the wavelength swept laser, a second arm in optical communication, with the source arm of the interferometer, and having a third and forth arm; a trigger generator in optical communication with the third arm of the power splitter, and having a trigger output; and a sample clock generator in optical communication with the forth arm of the power splitter and having a sample clock output. The trigger output of the trigger generator and the sample clock output of the sample clock generator is in electrical communication with the trigger input and sample clock input of the analog to digital computer, and the analog to digital converter can convert a signal from the first photo detector in response to a trigger signal from the trigger generator and a sample clock signal from the sample clock generator. [0011] In some embodiments, the OCT system further includes an optical switch in optical communication between the reference arm and the reference reflector. [0012] In some embodiments, the probe of the OCT system further includes an OCT imaging optical system. [0013] In some embodiments, the OCT system includes: a second light source; a spectrometer having an optical input and an electrical signal output; an optical circulator having a first arm in communication with the second light source, a second arm in optical communication with the spectrometer optical input, and a third arm; and a wavelength division multiplexer in optical communication between the sample arm of the interferometer and the probe interface and having a third arm in optical communication with the third arm of the optical circulator, where the electrical signal output of the spectrometer is in electrical communication with the processor system. [0014] In some embodiments of the OCT system, the analog to digital converter has a second signal input; the power splitter further includes a fourth arm; the probe interface further includes a second optical connector; and the OCT system further includes: a second photodetector, the second photodetector including an electrical signal output and a optical signal input and a circulator. The circulator includes: a first arm in optical communication with the fourth arm of the power splitter; a second arm in optical communication with the optical input of the second photodetector; and a third arm in optical communication with the second optical connector of the probe interface, and the electrical signal output of the second photodetector can be in electrical communication with the second signal input of the analog to digital converter. [0015] In some embodiments of the OCT system, the circulator is a multimode circulator and the third arm of the circulator is a multimode fiber; and the optical coherent tomography system further includes a single mode to multimode converter optically connected between the power splitter and the multimode circulator. The fourth arm of power splitter includes a single mode optical fiber, and the first arm of the circulator includes a multimode optical fiber. [0016] The invention also provides, in part, a probe for an OCT system. The probe in one embodiment includes: a body defining a bore and having a first end and a second end; an optical fiber located within the bore, the optical fiber having a first end and a second end; an optical pressure transducer located within the bore and in optical communication with the first end of the optical fiber; and a fiber optic connector, located at the second end of the body and in optical communication with the second end of the optical fiber, where the body further defines at least one opening from the bore to the environment by which pressure from the environment is transmitted to the optical pressure transducer. In some embodiments, the second end of the optical fiber includes a fiber optic ferrule. [0017] In some embodiments, the probe further includes a spring tip positioned at the first end of the body. [0018] In some embodiments, the probe further includes a removable torque handle removably attached to the body. [0019] In some embodiments of the probe, the fiber optic connector defines a bore and includes a mating unit sized and configured to receive the fiber optic ferrule, and the fiber optic connector further includes a locking clamp to removably attach the body to the fiber optic connector. [0020] In some embodiments of the probe, the body further includes a guide having a first end and a second end, the guide positioned at the first end of the body and defining a second bore, the second bore sized and shaped to permit a guide wire to enter the guide through a first opening in the first end of the guide and to pass through the second bore and out through a second opening in the guide. In some embodiments, the optical fiber and the optical pressure transducer are movable within the bore. In some embodiments, the optical fiber passes through a liquid seal located in the bore adjacent the fiber optic connector. [0021] The invention also provides, in part, a combination probe for an OCT system. The combination probe includes: a body having a wall defining a bore and having a first end and a second end; an optical fiber located within the bore, the optical fiber having a first end and a second end; a partial reflector located within the bore and positioned to reflect a first portion of light received from the first end of the optical fiber from through the wall of the body; an optical pressure transducer located within the bore and positioned to receive a second portion of light from the first end of the optical fiber; and a fiber optic connector, located at the second end of the body and in optical communication with the second end of the optical fiber, where the body further defines at least one opening from the bore to the environment by which pressure from the environment is transmitted to the optical pressure transducer. [0022] The invention also provides, in part, a method of determining pressure in a vessel as measured by an optical pressure transducer in an OCT system which includes an interferometer having a photodetector located in a detector arm of the interferometer and having an optical pressure transducer located in the sample arm of the interferometer. The method includes the steps of sampling a signal from the photodetector to form a sampled pressure signal; normalizing the sampled signal to obtain a normalized sampled pressure signal; removing cavity noise to form a cleaned normalized sampled pressure signal; finding a minimum value in the cleaned normalized sampled pressure signal; and tracking the minimum value of the cleaned normalized sampled pressure signal. In some embodiments of the method, the minimum value is determined by one of convolution, differentiation and gradient searching. In some embodiments, the method further includes the steps of: inserting a catheter having an optical pressure transducer into a vessel; and moving the optical pressure transducer within the catheter. [0023] The invention also provides, in part, a method of obtaining an OCT image in a blood vessel using an OCT/pressure probe system. The method includes the steps of inserting a combination OCT/pressure probe catheter into the blood vessel; setting the OCT/pressure probe system to measure pressure; determining the pressure drop across a putative stenotic region of the vessel; setting the OCT/pressure probe system to image; and taking an OCT image of the putative stenotic region. [0024] This Summary is provided merely to introduce certain concepts and not to identify any key or essential features of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS [0025] The objects and features of the invention can be understood more completely by referring to the drawings described below and the accompanying descriptions. [0026] FIG. 1 illustrates an embodiment of the design of an optical pressure transducer known to the prior art that is suitable for use with the Fourier-domain optical coherence tomography system. [0027] FIG. 2 is a block diagram of an embodiment of an FD-OCT imaging system that is capable of collecting data from an optical pressure sensor or OCT imaging probe according to the present invention. [0028] FIG. 3 is a block diagram of another embodiment of an FD-OCT imaging system that is capable of collecting data from an optical pressure sensor or OCT imaging probe according to the present invention. [0029] FIG. 4 is a block diagram of yet another embodiment of an FD-OCT imaging system that is capable of collecting data from an optical pressure sensor according to the present invention using a multi-mode optical pressure probe. [0030] FIG. 5 is a block diagram of still yet another embodiment of an FD-OCT imaging system that is capable of collecting data from an OCT imaging catheter and an optical pressure sensor operating in different optical wavelength bands. [0031] FIG. 6 a is a cross-sectional view of the distal end of an embodiment of a steerable intravascular pressure probe constructed in accordance with the invention. [0032] FIG. 6 b is a cross-sectional view of the proximal end of a steerable intravascular pressure probe of FIG. 6 a. [0033] FIG. 6 c is a cross-sectional, view of the distal end of an embodiment of the probe in which the tube diameters proximal and distal the transducer are smaller than the tube diameter adjacent the transducer. [0034] FIG. 7 a is a cross-sectional view of the distal end of an embodiment of a steerable intravascular pressure wire with a detachable optical adapter constructed in accordance with the invention. [0035] FIG. 7 b is a cross-sectional view of the proximal end of a steerable intravascular pressure wire with a detachable optical adapter of FIG. 7 a. [0036] FIG. 8 a is a cross-sectional view of the distal end of an embodiment of a rapid-exchange intravascular catheter with a single pressure sensing port constructed in accordance with the invention. [0037] FIG. 8 b is a cross-sectional view of the proximal end of a rapid-exchange intravascular catheter with a single pressure sensing port of FIG. 8 a. [0038] FIG. 9 a is a cross-sectional view of the distal end of an embodiment of a rapid-exchange intravascular catheter with multiple pressure sensing ports. [0039] FIG. 9 b is a cross-sectional view of the proximal end of a rapid-exchange intravascular catheter with multiple pressure sensing ports of FIG. 9 a. [0040] FIG. 9 c is a section through A-A′ of the embodiment of FIG. 9 b. [0041] FIGS. 9 d - f show a schematic diagram of an embodiment of a multi-hole probe and graphs of various pressure measurements made by the probe at various positions in a stenotic vessel. [0042] FIG. 10 is a cross-sectional view of the distal end of an embodiment of a rotational OCT imaging intravascular catheter that also functions as an intravascular pressure monitor. [0043] FIG. 11 shows examples of waveforms recorded from an optical pressure sensor by an optical coherence tomography system operating in the pressure-sensing mode. [0044] FIG. 12 is an example of a calibration curve of an optical pressure sensor. [0045] FIG. 13 compares dynamic pressure reading obtained from an electronic pressure sensor and an optical pressure sensor configured to operate with an FD-OCT system in accordance with the present invention. [0046] FIGS. 14 ( a, b ) show an example of dynamic pressure readings obtained from an optical pressure sensor during pullback through a model of a stenosed blood vessel and the corresponding region in the vessel at which the readings were taken. DETAILED DESCRIPTION [0047] The following description refers to the accompanying drawings that illustrate certain embodiments of the invention. Other embodiments are possible and modifications can be made to the embodiments without departing from the spirit and scope of the invention. Therefore, the following detailed description is not meant to limit the present invention. Rather, the scope of the present invention is defined by the claims. [0048] The present invention arises from the realization that the basic architecture of a frequency-domain OCT (FD-OCT) system, configured in a specific manner, permits a user to make an intravascular blood pressure measurement when used in conjunction with fiber-optic Fabry-Perot pressure transducers. FIG. 1 illustrates the basic structure of a Fabry-Perot optical pressure transducer 10 , known to the prior art, that is compatible with the combined OCT imaging/pressure measurement system disclosed herein. A Fabry-Perot cavity 14 is formed by the surfaces of a diaphragm 18 and the sensor body 22 and has a reflectivity that depends on optical frequency or wavelength of the light exiting the optical fiber 26 . [0049] The depth of the cavity lies typically within the range of 1-20 μm and its width, which is limited by the diameter of the body of the sensor, lies typically in the range of 0.15-0.4 mm. Light from an optical fiber 26 impinges on the cavity 14 and the same fiber 26 collects the reflected light as the diaphragm 18 flexes in response to external pressure variations. When the sensor 10 is excited by a laser, the optical signals returning from the cavity 14 through the optical fiber 26 combine and generate a common-mode interference signal. An PD-OCT system, configured according to the present invention, performs the functions required to record these interference signals. Algorithms are discussed below for processing the interference signals and displaying blood pressure waveforms. [0050] One embodiment of an FD-OCT system 30 that is suitable for combined OCT imaging and blood pressure measurement according to the present invention is shown in FIG. 2 . Because it performs both functions with little additional hardware, it is a simple cost-effective embodiment of the combined system. A wavelength-swept laser 34 (also referred to as an ‘optical-frequency tunable laser’ or ‘swept-source laser’) emits nearly monochromatic (line width<0.2 nm) near-infrared light within a specific spectral band suitable for intravascular OCT imaging. The most common band of emission wavelengths lies within the telecommunications O band (1260≦λ≦1360 nm). The wavelength of the laser 34 is swept or stepped rapidly over a broad band of wavelengths. The sweep is completed typically within a period less than 20 μs and repeats 10,000 times or more each second. An optical power splitter 38 separates the light into three channels. The first channel, which includes a fiber Bragg grating filter 42 (or equivalent wavelength-selective filter) with a narrow bandpass (typically<1 nm) and a trigger generator 46 , provides a timing pulse to the main analog-to-digital converter 50 that triggers the data acquisition. This channel produces a tinting pulse at a predetermined optical frequency or wavelength (typically 238 THz or 1260 nm) when the output of the laser sweeps through the passband of the fiber Bragg grating filter. The timing pulse triggers the start of the acquisition of the analog signals from the photoreceiver on each edge of the sample clock. [0051] Light in the second channel is routed through a single-mode optical fiber to a sample clock generator 54 , which includes a reference interferometer and associated electro-optics that generate sample clock pulses at fixed optical frequency intervals. The sample clock generator ensures that the signals from photoreceiver 94 are collected by the data acquisition and display unit 102 synchronously with the sweep of the laser 34 at known wavelength steps. A fiber-optic Mach-Zehnder, Michelson interferometer, optical etalon, or equivalent type of interferometer with a known optical path difference can serve as the reference interferometer of the clock generator 54 . [0052] Light in the third channel is conducted through a single-mode optical fiber to the main interferometer 58 which splits the light into reference 60 and sample arms 62 . The light in the reference arm passes through an optical switch 64 to a reference mirror 66 that sets the zero-point optical delay for the imaging system and determines the depth into the tissue at which the OCT imaging will take place. The light in the sample arm 62 passes to a motorized fiber-optic rotary coupler 70 in the probe interface 74 . The probe interface 74 includes a connector 78 which permits various probes (combined OCT imaging/pressure measuring catheter 82 , OCT imagining 86 or optical pressure measuring probe 90 ) to connect to the sample arm 62 of the interferometer 58 . [0053] A motorized translation stage in the probe interface 74 enables the fiber-optic core of the catheter ( 82 , 28 , 90 ) inserted into a vessel to pull back with a constant speed. The optical output of the main interferometer 58 is converted by the photodetector 94 to electrical signals representative of the interference signals from the sample 60 and reference arms 62 of the interferometer 58 . These electrical signals are converted to digital signals by the analog to digital converter (A/D) 50 and processed and displayed on the display unit 98 of the data acquisition system 102 . Because the trigger generator 46 and clock generator 54 are synchronized, the absolute optical frequency of the interference signal acquired by the data acquisition system 102 during every laser sweep can be determined from the number of sample clock pulses acquired after each trigger pulse from the trigger generator 46 . The absolute frequency reference is provided, by the fiber-Bragg grating, which indicates the starting optical frequency; subsequent steps occur at equal optical frequency intervals set by the sample clock generator. [0054] In one embodiment of the invention shown in FIG. 2 operates either in the OCT imaging mode, pressure mode, or combined OCT/pressure mode depending on whether an OCT imaging 86 catheter, pressure probe 90 , or combined OCT/pressure catheter 82 is attached to the probe interface connector 78 . The mode of operation can be selected manually or automatically, depending on the system configuration. Manual selection requires the user to choose the operating mode from a software menu. Automatic selection can be accomplished in one of several ways. [0055] In one embodiment with the motorized fiber-optic rotary coupler 70 in a stationary position, data acquisition unit 102 initiates after either the OCT imaging catheter 86 or pressure probe 90 has been inserted. A software algorithm identifies the type of probe according to the interference signal pattern detected by the main interferometer 58 and photodetector 94 and loads the appropriate control and display software. Once the pressure measurement has been completed, the precise location and the severity of the stenosis can be determined and the OCT imaging procedure can begin. [0056] In a second embodiment of the system to automatically determine what type of probe is connected to the system, following insertion of the catheter 86 or pressure probe 90 , the system attempts to rotate the motorized fiber-optic rotary coupler 70 . A torque sensor in the motor of the motorized coupler 70 measures resistance to rotation. Torque exceeding a specific threshold indicates that a pressure probe 90 , with a non-rotating proximal connection, is attached. Once insertion of a pressure probe 90 has been detected, the motor disengages and the appropriate control and display software loads. [0057] In a third embodiment, an encoded electrical or optical tag (e.g., bar code, wire-encoded electrical connector, RFID tag, flash memory chip) on the proximal end of the OCT imaging catheter 86 or pressure probe 90 (or both 82 ) is read by the system to identify the appropriate mode of operation. The tag can be read automatically by the probe interface 74 when the probe is inserted or, alternatively, a handheld device can be employed to read the marker from the body or package of the probe. This method of probe identification has the advantage that additional factory calibration data encoded in the markers can be read at the same time. [0058] In addition to features that enable automatic software configuration, the system of FIG. 2 also contains features that enable automatic hardware configuration once the operational mode has been determined. In the standard OCT imaging mode, optical switch 64 is actuated, allowing light to reflect from the reference mirror 66 . However, in the pressure-measurement mode, because the system records common-mode interference signals and no reference light is required, the optical switch 64 is turned off, isolating the reference reflector 66 from the reference arm 60 of the interferometer 58 . In addition, since differential (balanced) photodetection is employed, only during OCT imaging, the electronic balancing circuits in the photoreceiver 94 are switched to the single-ended (unbalanced) mode during pressure measurements. [0059] FIG. 3 is a block diagram of another embodiment 30 ′ of the invention in which separate optical connections are provided on the probe interface 74 ′ for the OCT imaging catheter 86 and optical pressure probe 90 . This configuration enables acquisition of blood pressure measurements with a separate pressure probe 90 before, during, or after OCT imaging. Measurement of pressure during OCT imaging can be accomplished by inserting both probes in the blood vessel at the same time. An additional optical channel 112 from the power splitter 38 ′ directs light to the pressure probe 90 through an optical circulator 116 . The optical circulator 116 re-directs the light that returns from the pressure probe 90 into a second photodetector 120 that generates the electronic signal corresponding to interference signals from which the pressure measurements are derived. These signals are digitized by a second channel of the analog to digital converter 50 ′ and recorded by the same data acquisition system 102 ′ used to record the OCT interference signals. In contrast to the first embodiment of the invention illustrated by FIG. 2 , no optical switch 64 is required in the reference arm 60 to isolate the reference arm 60 from the reference reflector 66 ( FIG. 2 ) during pressure measurement. [0060] A third embodiment of invention 30 ″, illustrated in FIG. 4 , is similar to that shown in FIG. 3 , except a multi-mode (MM) fiber 124 is used instead of a single-mode (SM) fiber 112 to conduct light over part of the path from the laser 34 to the optical pressure probe 90 . The larger core of the multi-mode (MM) fiber 124 facilitates fabrication of the pressure probe and reduces the tolerances for aligning the fiber-optic connection at the probe interface 78 ′ to the proximal end of the pressure probe. Typically, a 50-μm or 62.5-μm diameter graded-index MM telecommunications fiber may be used in this application. To reduce inter-modal interference noise, a passive SM-to-MM converter 128 , may be employed to launch light from the laser 34 into the MM fiber 124 . [0061] FIG. 5 illustrates a fourth embodiment 30 ″′ of the invention that enables simultaneous acquisition of OCT images and pressure measurements from a single fiber-optic catheter that contains both an OCT optical lens assembly and an optical pressure transducer as described below. The OCT and pressure interference signals are detected in two non-overlapping wavelength bands, for example, 1250-1350 nm and 1500-1600 nm or 1000-1200 nm and 1500-1600 nm, respectively. A superluminescent diode 130 emits broadband light that combines with the OCT laser light in a wavelength-division multiplexer 134 after passing through an optical circulator 138 . The combined light from the main interferometer 58 sample arm 62 and the superluminescent diode 130 travels in the same SM optical fiber to the tip of the catheter where light in the appropriate band (as described below in conjunction with the probe) impinges upon and reflects from either the tissue or the pressure transducer [0062] The reflected light is passed back down the fiber and separated again into two wavelength bands by the wavelength division multiplexer 134 . Light reflected by the tissue in first band enters the main OCT interferometer 58 through the sample arm 62 and light reflected by the pressure transducer in the second band enters a spectrometer 40 again after passing through the optical circulator 138 . The spectrometer 140 records the spectrum of the light reflected from the pressure transducer and transmits the spectral data to the processor and display system 98 ′ over a digital interface. [0063] FIGS. 6-10 illustrate the designs of pressure-sensing catheters that are compatible with an FD-OCT system configured according to the various embodiments of the invention. Each of the catheters contains a miniature optical pressure sensor at the tip of a small-diameter (80 μm- or 125 μm-diameter) optical fiber. The diameters of the sensor and fibers are small enough to enable the fabrication of pressure-sensing catheters with dimensions of coronary and neurovascular guide wires (0.010-0.014″). [0064] FIGS. 6( a - b ) show cross-sectional views of the proximal and distal ends of one of the embodiments of the optical pressure probe. The pressure probe 90 includes of a long hollow flexible tube 150 or an assembly of tapered tubes with an optical transducer 10 ′ mounted at the base of a spring tip 154 located at the distal end of the probe. The optical fiber 155 from the pressure transducer 10 ′ connects to a fiber-optic connector 157 mounted on the proximal end of the probe. Pressure-sensing slots or holes 160 in the mounting collar 164 at the base of the spring tip 154 transmit the blood pressure from the vessel in which the probe is inserted to the diaphragm 18 of the pressure transducer 10 ′. Alternatively the optical pressure transducer 164 is exposed to the blood flow directly. Preferably, the hollow body of the tube 150 is composed of a metal, metal alloy, or metal-braided polymer that gives the tube sufficient resistance to compression and rigidity to torque, while maintaining a high degree of flexibility. [0065] To minimize the restriction of flow caused by placement of the probe across a tight stenosis in a blood vessel, the body of the probe at its distal end is fabricated typically with an outer diameter of 0.010-0.018″ (0.25-0.46 mm). To position the pressure probe, the operator inserts the probe through a guide catheter into the artery and steers the probe to the target location using a torque handle 168 located near the proximal end. In accordance with the design of the FD-OCT system of FIG. 2 , operating in the pressure measurement mode, the fiber-optic rotary coupler 70 in the probe interface 74 rotates passively. The tip of the pressure probe 90 can be steered to the target location in the blood vessel by disconnecting the fiber-optic connector from the probe interface to allow free rotation of the body of the probe. After the pressure wire has been positioned, the fiber-optic connector can then be re-inserted into probe interface to obtain pressure measurements. Alternatively, since the fiber-optic rotary coupler in the probe interface rotates passively, the tip of the pressure probe can be steered without disconnecting the fiber-optic connection. Fabricating the pressure probe with a longer body (˜2 meters) facilitates this alternative steering method. If the probe interface does contain a rotatable element, the proximal end of the transducer may be made flexible between the removable torque handle 168 and the angle polished fiber optic connector 157 . This allows the pressure wire to be steered with a simpler probe interface unit. [0066] It should be noted that the diameter of the probe need not be constant across the transducer. FIG. 6 c depicts a cross-sectional view of the probe of FIG. 6 a but in which the diameter of the probe varies. The widths distal (D) and proximal (D′) to the transducer 164 are less that the width necessary to encompass the transducer 164 . This configuration functions because the wider diameter at the transducer 164 and opening 160 is not located within the stenotic region when pressure is measured. Hence, the diameter of the vessel in the region outside the stenosis is sufficiently large to permit pressure to enter through hole 160 without constricting flow and generating an anomalous pressure reading. [0067] FIGS. 7( a - b ) show cross-sectional views of an alternative construction of an optical pressure probe. Similar to the probe shown in FIG. 6 , the distal end of the probe shown here is constructed from a long flexible hollow tube 150 or an assembly of tapered tubes with the pressure sensing port located at the base of its spring tip 154 . However, the probe shown in FIG. 7 b includes a disposable optical adapter 172 that gives the operator access to the proximal end of the adapter. This configuration enables the pressure probe to serve as a primary guide wire over which a balloon catheter or other interventional device can be inserted into the artery. For compatibility with standard devices employed in coronary interventions, the pressure probe is fabricated, with an outer diameter of less than 0.014″ (0.36 mm) over its entire length. An end-polished fiber-optic ferrule 176 , with an outer diameter approximately equal to that of the body of the probe, mates precisely with a similar fiber-optic sleeve 180 inside the optical adapter 172 . To maintain a high optical transmission during free rotation of the proximal end, while minimizing back reflection, the mating fiber-optic ferrules 176 , 180 are fabricated, preferably, with Ultra Physical Contact (UPC) polished end faces. In some embodiments, separate disposable optical adapter 172 , which is supplied to the user as a separate sterilized component, plugs into the probe interface of the FD-OCT system and remains connected throughout the procedure. At the completion of the procedure, the adapter and the probe are removed as a unit by the user for disposal. [0068] To position the pressure probe 90 ′, the operator the proximal end of the probe 90 ′ from the optical adapter 172 , inserts the probe 90 ′ through a guide catheter into the artery, and steers the probe 90 ′ to the target location using the removable torque handle 168 at the distal end. Once the wire has been positioned and any additional device has been inserted over the pressure probe, the operator re-inserts the proximal end of the probe into the optical adapter 172 and locks the clamp 184 to keep the surfaces of the optical fibers 176 , 180 in close contact if the pressure probe 90 ′ moves. [0069] FIGS. 8( a - b ) show yet another alternative construction of an optical pressure probe 90 ″ that is suitable for intravascular pressure measurement with an FD-OCT system configured according to the various embodiments of the invention. Unlike the pressure probes 90 , 90 ′ illustrated in FIGS. 6 and 7 , this version of the pressure probe is designed for rapid delivery over a primary guide wire. [0070] In many instances, especially when an artery is tortuous or otherwise difficult to access, the clinician prefers to employ an independent primary guide wire rather than to steer the unsupported pressure probe to the target site. The guide wire (not shown) is inserted at the probe tip 190 and exits through the guide wire exit 194 . The guide wire is inserted into the vessel and moved to the position of interest in the vessel. The pressure probe 90 ″ is next inserted into the vessel over the guide wire and also moved to the place of interest in the vessel. The position of the pressure transducer can be monitored under x-ray imaging using the radio-opaque marker 198 located on the probe. The guide wire may then be removed and the pressure measurements performed. [0071] Eliminating the need for steerability of the pressure probe 90 ″ makes the rapid-exchange pressure wire easier and less costly to fabricate; however, to minimize restriction of blood flow, its cross section should be kept small. Therefore, to avoid inaccurate measurement of vascular resistance, the relatively large-diameter tip of the pressure probe must be placed far enough away from a tight vessel stenosis to prevent further restriction of blood flow. To satisfy this constraint, in one embodiment, the distance from the exit port of the guide wire to the pressure sensor (labeled ‘L’ in FIG. 8 a ) is set to 2-4 cm. The offset of the pressure sensor 10 ′ relative to the tip 190 enables the user to place the largest-diameter segment of the probe outside of the stenosis during the measurement of pressure both distal and proximal to the stenosis. [0072] The utility and ease of use of the rapid-exchange version of the pressure probe can be improved by modifying its construction according to FIGS. 9 ( a - b ). The distal end of the pressure probe 90 ″ shown in this figure includes a series of ports 160 ′ at evenly spaced intervals (typically 2-5 mm) that transmit the pressure at particular points along the axis of the artery to the inner lumen of the probe. An optical pressure transducer 10 ′ at the tip of an optical fiber inside the lumen of the pressure probe senses the local pressure in the vicinity of the pressure ports. The optical fiber and attached pressure transducer are designed to translate longitudinally inside the lumen as the motor inside the probe interface pulls the fiber connector back at a constant speed. Before use, the probe is flushed with saline. A liquid seal at the proximal end between the optical fiber and the non-rotating shell over the body of the fiber-optic connector prevents the escape of fluid into the probe interface. [0073] To perform a pressure measurement, the clinician, inserts the tip of probe 90 ″′ across the target lesion and pushes it forward until the target lesion lies between the radio-opaque markers 198 ′, 198 ″ on both sides of the series of pressure ports. The measurement is initiated by activating the automated pullback mechanism (part of the standard FD-OCT probe interface), which pulls the transducer 10 ′ along the length of the probe 90 ″ lumen at a constant velocity adjacent the series of pressure-sensing ports 160 ′. The pressure measured as a function of time provides a profile of the pressure across the lesion. [0074] FIG. 9 d shows an embodiment of a multi-hole probe within the lumen of a stenotic vessel. FIG. 9 e shows the measured pressure at various positions in the vessel corresponding to the cross-section in FIG. 9 d and the pressure values measured by the transducer at each of the holes in the probe. FIG. 9 f shows the pressure readings by the transducer as it is moved by the individual holes. Because the transducer determines the pressure downstream (distal) from it, a stepped pressure measurement is obtained as the transducer moves by the individual holes. The pressure errors introduced by this technique are minimal. [0075] FIG. 10 is a cross-sectional view of the tip of a catheter that combines the functions of an intravascular OCT imaging probe and a pressure wire. Depending on its construction, the combination catheter is compatible with the embodiments of the FD-OCT system shown in FIG. 2 and FIG. 5 . The key feature of the combined catheter is the integration of the pressure transducer into the tip of the OCT imaging catheter. An optical Fabry-Perot pressure transducer 10 ″ is mounted on the distal end of a short length (typically 1-2 mm) of coreless or large-core step-index multimode fiber 26 ′. The distal end 202 of the fiber segment is polished at an angle of 40-50 degrees and coated with a thin dielectric or metallic film. To avoid excessive back-reflection from the distal end of a fiber-tip lens assembly 206 , the fiber segment 26 ′ with the attached transducer is glued to the fiber-tip lens assembly 206 with an adhesive 210 that matches the refractive index of the lens 206 . [0076] For use of the combination catheter with the FIG. 2 embodiment of the FD-OCT system in which both the OCT system and pressure transducer operate in the same wavelength band (typically 1260-1360 nm), the thin-film coating on the angle-polished end of the fiber segment is selected to reflect a large fraction (75-90%) of the incident light at specific wavelengths for OCT measurements and to transmit the remaining fraction to the transducer 10 ″ for pressure measurements. Since reflection from the Fabry-Perot cavity of the pressure transducer 10 ″ modulates the spectrum of the raw OCT interference signal a series of artifactual lines appear in the OCT image at a depth proportional to the modulation frequency. To avoid degradation of the OCT image caused by these lines, the zero point of the OCT interferometer can be set by setting the delay in the interferometer such that the lowest frequency of the displayed OCT signals exceeds the peak frequency of the spectral modulation. [0077] For use of the combination catheter with the FIG. 5 embodiment of the FD-OCT system in which the OCT system and the pressure transducer operate in the first and second wavelength bands, respectively; the thin-film coating on the angle-polished end 202 of the fiber segment 26 ′ is selected to reflect light maximally in the first wavelength band and to transmit light maximally in the second wavelength band. With the lens 206 and pressure transducer 10 ″ attached to its tip, the optical fiber mounts inside the lumen of torque wire 214 that rotates inside the catheter sheath 218 . The catheter sheath is filled from the proximal port with saline or contrast medium. During pressure monitoring, the rotation of the torque wire 214 is turned off. The distal end of the catheter can employ either a monorail tip for rapid-exchange delivery, as in the embodiments shown in FIG. 8 and FIG. 9 , or a spring tip for insertion in the artery without a guide wire, as shown in the pressure wire embodiments in FIG. 6 and FIG. 7 . [0078] Other beam-splitting arrangements at the catheter tip are also possible. For example, the fiber-tip lens assembly can be angle-polished and coated, rather than the fiber attached to the transducer. Also, a bulk optical component; such as miniature prism or mirror, can be employed as a beam splitter instead of an angle-polished optical fiber. [0079] FIG. 11 shows a set of common-mode interference signals acquired from an optical pressure probe connected to an FD-OCT system that was configured according to the embodiment of the invention shown in FIG. 2 , operating in the pressure measurement mode. Acquired over a range of pressures (−40 mmHg<P<180 mmHg), the signals were recorded at successive optical dock intervals, in proportion to the wavenumber or optical frequency of the wavelength-swept laser. In this example, the abscissa spans an optical frequency range of 220-240 THz or, equivalently, a wavelength range of 1250-1360 nm. The low-frequency spectral modulation of the signal originates from reflections within the main Fabry-Perot cavity formed by the diaphragm and the body of the in the optical pressure transducer. The width of the cavity of the transducer in this example was approximately 17 μm. As shown by the arrows in FIG. 11 , the low-frequency modulation pattern shifts to higher frequencies in proportion to pressure. The high-frequency spectral modulation superimposed on the signal was caused by reflection from a “parasitic cavity” in the transducer 10 ′ formed by the interface between the input optical fiber 26 ′ and the sensor body 22 . Neither the frequency nor the amplitude of this parasitic modulation changes significantly with pressure. [0080] The characteristics of the time-dependent interference signal generated by the pressure transducer at the output of the photodetector (see for example 120 in FIG. 4 ) of the FD-OCT system can be expressed as: [0000] V ( t )= KP 0 ( k )└ r FP ( k,P )+ r p ( k )┘  (1) [0081] where K is a constant, P 0 (k) is the optical power incident on the transducer; r FP (k, P) and r p (k) are, respectively, the reflectivities of the Fabry-Perot and parasitic cavities of the pressure transducer. The interference signal, power, and transducer reflectivities are functions of the optical wavenumber (k) of the light emitted by the laser, which varies as an arbitrary function of time (t). In the FD-OCT system, the signal voltage (V) from the photodetector 94 is sampled by the analog-to-digital converter 50 at evenly spaced wavenumber intervals, k n =k 0 +(n−1)Δk; here, k 0 is the initial wavenumber of the laser sweep, Δk is the wavenumber sample interval, and n=1, 2, . . . N, where N is the number of samples. According to these definitions, the recorded digital pressure signal can be expressed as an array of N values measured at successive optical clock intervals (in proportion to wavenumber), [0000] V n =KP 0 ( k n )[ r FP ( k n ,P )+ r B ( k n )], for n= 0, 1, 2 , . . . N   (2) [0082] The reflectivity r FP varies in relation to the pressure-dependent length, L(P), of the Fabry-Perot cavity, according to: [0000] r FP  ( k n , P ) = 1 - 1 1 -  r c   sin  [ 2  k n  L  ( P ) ] =  r c   sin  [ 2  k n  L  ( P ) ]  r c   sin  [ 2  k n  L  ( P ) ] - 1 ( 3 ) [0083] Here, the magnitude of the effective reflection coefficient of the cavity, |r c |, is approximately equal to the geometrical mean of the magnitudes of the reflection coefficients of the reflecting surfaces of the Fabry-Perot cavity. For most transducers, the length (L) decreases approximately linearly with pressure over a wide range of pressures. The parasitic reflectivity, r B (k), generated by M parasitic cavities within the transducer's body or packaging, generates pattern noise composed of sinusoids of different frequencies, [0000] r p ( k n )=| r p1 |sin(2 k n l 1 )+| r p2 |sin(2 k n l 2 )+ . . . +| r pM |sin(2 k n l M )  (4) [0084] where |r p1 |, |r p2 |, . . . , |r pM | are the magnitudes of the effective reflection coefficients of the parasitic cavities and l 1 , l 2 , . . . l m are the lengths of the parasitic cavities. [0085] These three equations, 2, 3 and 4 represent a mathematical model of the signal recorded by the FD-OCT system. The nominal Fabry-Perot cavity length (L) at a given pressure in Equation 3 is known from the manufacturing process. The reflection coefficient |r c | is determined by fitting signals measured from a sampled number of pressure transducers. In practice, a single parasitic cavity usually dominates, and its length and effective reflection coefficient can be determined by Fourier transformation of pressure signals measured from the sampled number of pressure transducers. [0086] In accordance with the present invention, the algorithm for processing the pressure signal proceeds according to following steps: [0087] First the signal is normalized by dividing the recorded signal array of voltages (V n ) by the laser power to obtain the normalized signal: [0000] V n 0 =V n /P ( k n )  (5) [0088] Next the parasitic cavity noise is removed by applying a Butterworth or equivalent low-pass filter to the normalized signal (V n 0 ) with a cut-off frequency below that of the lowest frequency component of the reflection coefficients r p (k). The result is: [0000] V n,F 0 =LPF{ V n 0 }  (6) [0000] where LPF{ } represents the low-pass filtering operation. Next the spectral null, the sample wavenumber at which the amplitude of V n,F 0 is lowest, is detected. V n,F 0 is first convolved with a template array of values proportional to r FP (k), with |r c | and L(P) determined by fitting filtered arrays measured from a sample of transducers at reference pressures. The spectral null of V n,F 0 occurs at the array index n min at which the amplitude of the convolved is maximum. Alternatively, the minimum, maximum or steepest edge of V n,F 0 can be located by conventional differentiation or gradient-search methods known to persons skilled in the art. [0089] The spectral null is then tracked and unwrapped. If more than one spectral null of V n,F 0 occurs within the pressure range of interest or nulls move out of the laser's wavelength band at the extremes of the pressure range, the position of nulls can be tracked across multiple laser sweeps to extend the pressure measurement range. Tracking can be accomplished by standard phase unwrapping techniques applied to a sequence of stored V n,F 0 array values. [0090] FIG. 12 shows a calibration, curve of a typical pressure transducer. The curve was obtained by applying the above algorithm to the raw pressure signals in FIG. 11 . Since the optical clock interval number at which the spectral null occurs, n min , varies approximately in linear proportion to the applied pressure, the pressure can be estimated accurately from n min once the slope and offset of the calibration curve are known. In practice, a polynomial function is used to fit the calibration curve of an individual pressure probe or catheter and the stored coefficients are employed to estimate pressure from measured n min values. [0091] FIG. 13 shows dynamic pressure waveforms measured by the same pressure probe from which the raw signals in FIG. 11 were obtained. In this example, good correspondence compared to a commercial strain-gage transducer was obtained by using a simple first-order polynomial (linear) calibration curve. FIG. 14 shows the pressure waveforms measured by the pressure probe across a tight stenosis in a simulated artery. In this experiment, the pressure-sensing segment of the pressure probe was pulled through the stenosis at a constant speed by a motor in the probe interface. The sharp reductions in both mean and pulsatile pressures provide clear evidence of the flow resistance imposed by the stenosis. [0092] The examples presented herein are intended, to illustrate potential and specific implementations of the invention. It can be appreciated that the examples are intended primarily for purposes of illustration of the invention for those skilled in the art. There may be variations to these diagrams or the operations described herein without departing from the spirit of the invention. For instance, in certain cases, method steps or operations may be performed or executed in differing order, or operations may be added, deleted or modified. [0093] Variations, modification, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and scope of the invention as claimed. Accordingly, the invention is to be defined not by the preceding illustrative description, but instead by the spirit and scope of the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Not applicable. FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable. SEQUENCE LISTING [0003] Not applicable. BACKGROUND—FIELD OF INVENTION [0004] This invention relates to infant feeding bottles, and particularly to those of a type used with powdered milk. BACKGROUND—DESCRIPTION OF PRIOR ART [0005] In a commonly used arrangement for bottle-feeding infants, the bottle is filled with water, to which powdered milk is added only when the baby is to be fed. That way, especially during car trips or visits away from home, or on other occasions when refrigeration may not be available for many hours at a time, the baby can be fed at any time without worrying about whether the milk has spoiled. Many hours can pass between bottle preparation and the feeding of the baby, without requiring refrigeration of the bottle. [0006] When feeding time arrives, the nipple is removed from the bottle, a measured amount of powder is added to the water through the now-open mouth of the bottle, the nipple is reinstalled, and the bottle is shaken to mix the contents. [0007] In such arrangements, the powder is generally stored in a can or in a similar container, often with a measuring spoon or scoop supplied within the same container. The can or other container may be carried, along with one or more water-filled bottles. Just before a feeding, the scoop is used to measure the proper amount of powder to add to the bottle contents. [0008] A can of powdered milk is somewhat heavy and bulky to carry away from home. Accordingly, smaller containers for milk powder have been provided which are washable and refillable. A known design has three chambers, each separately openable and each carrying a measure of powdered milk suitable for a single bottle. However, such a container still must be carried separate and apart from the bottles, and additional inconveniences arise when the number of bottles to be used does not match the number of storage chambers in the container, especially when the number of bottles exceed the number of storage chambers. [0009] In applications where a formula prepared by mixing two constituents has a short shelf-life or where the quantities, quality or sterility of the constituents is an important consideration in the preparation of the formula, a single container which could separately store the two constituents until the mixed formula is to be dispensed, permit the two constituents to be mixed in the container and permit the mixed formula to be dispensed from the container would be useful. [0010] U.S. Pat. No. 5,411,155 to Gordon et al. (1995) discloses a protective nipple cover with a chamber for storing a measured amount of powder for the bottle to be mixed when needed; however, the powder is stored externally to the bottle. The bottle must be opened to add the powder, thus exposing the contents of the bottle to accidental contamination. It also requires two hands and the caregiver's full attention to add the powder without spilling either the water or the powder. [0011] U.S. Pat. Nos. 6,045,254 to Inbar et al. (1997), 6,575,208 to Igal et al. (2001), and patent application 20010039977 to Igal et al. (2001) all disclose a complex bottle having two chambers, one that can hold water and another that can hold powder. A rotating displaceable partition between the two chambers allows the components to mix. The two chambers are integral parts of the bottle, requiring the caregiver to purchase the bottle as a unit, made more expensive by the numerous and complex moving parts. This does not allow the caregiver to take advantage of bottles already in their possession. Furthermore, it is designed for pre-packaged single use. The bottle assembly, with its numerous parts and required tolerances, would impede proper washing and extra care would be needed to ensure that all surfaces and crevices are completely cleansed after each use should the caretaker attempt to reuse the disposable bottle. [0012] Several other types of two chambered bottles have been proposed for seemingly industrial purposes—for example U.S. Pat. No. 5,692,644 to Gueret (1995), and patent applications 20020066677 and 20020066679, both (2001) to Moscovitz. Each involves a complex bottle or apparatus unsuited to administering infant formula. [0013] Inserts for baby bottles have been proposed for purposes unrelated to storing and releasing infant formula. U.S. Pat. No. 4,915,242 to Marte (1989) shows a fixed insert that releases medicines or vitamins at a slow rate into the nipple as the infant nurses on a pre-mixed formula. Marte's insert does not have a sealed chamber to store material; the material constantly communicates with the liquid contents. [0014] U.S. Pat. No. 6,041,951 to Blum (2000) shows a fixed insert that allows the infant to nurse regardless of the bottle orientation. It is not designed for storing and releasing a substance. [0015] Pre-measuring infant powder and water, storing them separately until needed, and the ability to mix the components quickly with a minimum of complexity, handling, attention, chance of contamination or spilling, cleanup, and waste due to single use, while utilizing the bottles, collars, and nipples already in possession, are desirable objectives. None of the above proposals provide an acceptable solution. BRIEF SUMMARY OF THE INVENTION [0016] A reusable bottle insert that stores a pre-measured amount of infant formula inside a feeding bottle also having a pre-measured amount of water and allows the powder and water to mix when desired. [0017] The bottle and insert can be prepared ahead of time in anticipation of a later need. This allows the caregiver to prepare the bottle in a more controlled environment, facilitating cleanliness and accurate measurements. [0018] The insert containing the powder resides inside the bottle and releases the powder into the water when a force external to the bottle is applied. This allows the bottle to remain sealed after preparation, ready for mixing, for as long as the sterility of the environment in which it was prepared allows. As it is not necessary to open the bottle to initiate the mixing, a minimum of handling and attention is required from the caregiver, and a significant opportunity for contamination and spilling is eliminated. [0019] The insert is inexpensive due to its compatibility with bottles the caregiver already possesses, its reusability, and its few parts. Its simple operation and lack of moving parts will also facilitate its cleaning. [0020] The bottle insert of the invention fulfills the desired objectives and provides many advantages not present in the prior art. BRIEF DESCRIPTION OF THE DRAWINGS [0021] In the drawings, closely related figures have the same number but different alphabetic suffixes. All sections are vertical through the center. [0022] FIG. 1A is an exploded perspective view of a typical prior art feeding bottle, collar, and nipple. [0023] FIG. 1B is a section view of a prior art bottle. [0024] FIG. 1C is a section view of a prior art nipple. [0025] FIG. 1D is a section view of a prior art collar. [0026] FIG. 1E is a section view of a prior art nipple mated to a prior art collar. [0027] FIG. 1F is a section view of a prior art one-piece nipple. [0028] FIG. 1G is a section view of a prior art nipple, collar, and bottle assembly. [0029] FIG. 1H is a section view of a prior art protective nipple cover. [0030] FIG. 1I is a section view of a prior art protective nipple cover mated with a prior art bottle assembly. [0031] FIG. 1J is a detail section view of a prior art protective nipple cover and collar connection. [0032] FIG. 2A shows a one-piece embodiment of the container insert in perspective. [0033] FIG. 2B is a section view of a one-piece container insert. [0034] FIG. 2C is a detail view of a one-piece container insert in perspective. [0035] FIG. 2D is a section view of a one-piece container insert filled with a material. [0036] FIG. 2E is a section view of a one-piece container insert filled with a material and sealed with a nipple-collar assembly. [0037] FIG. 2F is a section view of a one-piece container insert in the storing position. [0038] FIG. 2G is a section view of a one-piece container insert in the releasing position. [0039] FIG. 3A shows an exploded two-piece embodiment of the container insert in perspective. [0040] FIG. 3B is a section view of a two-piece container insert body. [0041] FIG. 3C is a detail view of a two-piece container insert body in perspective. [0042] FIG. 3D is a section view of an assembled two-piece container insert. [0043] FIG. 3E is a detail section view of an assembled two-piece container insert. [0044] FIG. 3F is a section view of a two-piece container insert body mated with a nipple-collar assembly. [0045] FIG. 3G is a section view of a two-piece container insert body mated with a nipple-collar assembly, inverted, and filled with a material. [0046] FIG. 3H is a section view of a two-piece container insert body mated with a nipple-collar assembly, inverted, filled with a material, and sealed with a cap. [0047] FIG. 3I is a section view of a two-piece container insert in the storing position. [0048] FIG. 3J is a section view of a two-piece container insert in the releasing position. [0049] FIG. 4A shows the preferred two-piece container insert, exploded and perspective. [0050] FIG. 4B is a section view of the preferred two-piece container insert body. [0051] FIG. 4C is a detail view of the preferred two-piece container insert body in perspective. [0052] FIG. 4D is a section view of the preferred two-piece container insert assembled. [0053] FIG. 4E is a detail section view of the preferred two-piece container insert assembled. [0054] FIG. 4F is a section view of the preferred two-piece container insert body mated with a nipple-collar assembly. [0055] FIG. 4G is a section view of the preferred two-piece container insert body mated with a nipple-collar assembly, inverted, and filled with a material. [0056] FIG. 4H is a section view of the preferred two-piece container insert body mated with a nipple-collar assembly, inverted, filled with a material, and sealed with a cap. [0057] FIG. 4I is a section view of the preferred two-piece container insert, filled and mated with a nipple-collar assembly, with a protective nipple cover. [0058] FIG. 4J is a section view of the preferred two-piece container insert in the storing position. [0059] FIG. 4K is a section view of the preferred two-piece container insert in the intermediate releasing position. [0060] FIG. 4L is a section view of the preferred two-piece container insert in the full releasing position. [0061] FIG. 5A shows an exploded three-piece embodiment of the container insert in perspective. [0062] FIG. 5B is a section view of a three-piece container insert body. [0063] FIG. 5C is a detail view of a three-piece container insert body in perspective. [0064] FIG. 5D is a detail view of a three-piece container insert sealing member in perspective. [0065] FIG. 5E is a section view of an assembled three-piece container insert. [0066] FIG. 5F is a detail section view of an assembled three-piece container insert. [0067] FIG. 5G is a section view of partially assembled three-piece container insert filled with a material. [0068] FIG. 5H is a section view of fully assembled three-piece container insert filled with a material. [0069] FIG. 5I is a section view of a three-piece container insert in the storing position. [0070] FIG. 6A is a section view in perspective of a one-piece container insert filled and packaged for immediate use. [0071] FIG. 6B is a section view in perspective of the preferred container insert filled and packaged for immediate use. [0072] FIG. 6C is a section view in perspective of a three-piece container insert filled and packaged for immediate use. REFERENCE NUMERALS IN DRAWINGS [0073] Prior Art Bottle Elements 10 bottle 11 outer wall 12 closed end 13 open end 14 opening 15 threads Prior Art Nipple Elements 20 nipple 21 flange 22 neck 23 retaining rib 24 closed end 26 opening 27 cavity 28 perforations Prior Art Collar Elements 30 collar 31 side 32 end 33 opening 34 threads 35 flange 36 opening 37 retaining rib 50 nipple-collar assembly 51 one-piece nipple Prior Art Cover Elements 52 cover 53 open end 54 opening 55 closed end 56 recess 57 side 58 retaining rib 60 bottle assembly 61 liquid 62 material Common Insert Elements 70 graduations 71 packaging 72 castellations 73 rounded corners 74 sealing member 75 pull tab One Piece Insert Elements 100 container insert 101 outer wall 102 closed end 104 open end 105 opening Two Piece Insert Elements 200 insert body 201 outer wall 202 open end 203 opening 204 open end 205 opening 208 rib 210 sealing member 211 side 212 rib 250 container insert assembly Preferred Insert Elements 300 insert body 301 outer wall 302 open end 303 opening 304 open end 305 opening 308 flange 309 sealing member 310 sealing member 312 side 313 flange 314 groove 315 pushrod 316 bulb 350 container insert assembly Three Piece Insert Elements 400 insert body 401 outer wall 403 opening 406 castellations 408 flange 410 sealing member 412 side 413 flange 414 groove 415 fin 416 castellations 450 container insert assembly DETAILED DESCRIPTION OF THE INVENTION [0074] For readiest understanding of the invention, it is helpful to describe a prior art feeding bottle in some detail. [0075] Thus, in FIGS. 1A to 1 D, the components of a typical prior art bottle assembly 60 are shown, comprising a bottle 10 , a nipple 20 , and a collar 30 ( FIG. 1A ). Bottle 10 ( FIG. 1B ) is formed of plastic or glass. Bottle 10 is of hollow construction, with outer wall 11 closed off at closed end 12 , and with an opening 14 at open end 13 . Open end 13 has exterior threads 15 . Nipple 20 ( FIG. 1C ), formed of silicone or latex, has an outward flange 21 . Nipple 20 has a neck 22 formed by flange 21 and a retaining rib 23 . Nipple 20 has a closed end 24 with a plurality of perforations 28 . Nipple 20 is of hollow construction, forming a cavity 27 . Flange 21 has an opening 26 that allows a liquid (not shown) to be drawn into cavity 27 and out through perforations 28 . Collar 30 ( FIG. 1D ), which is formed of plastic, has a side 31 with interior threads 34 . Collar 30 has an inward flange 35 with an opening 36 . Collar 30 has an end 32 , with opening 33 . Flange 35 has an outward facing retaining rib 37 . [0076] FIG. 1E shows a section of a nipple 20 mated with a collar 30 , forming a nipple-collar assembly 50 . Closed end 24 is drawn through opening 33 and opening 36 , such that neck 22 is nested in opening 36 and nipple 20 is retained in this position by flange 21 and retaining rib 23 . [0077] FIG. 1F shows a section of a prior art one-piece nipple 51 , which is formed of rubber and plastic in a permanent bond. One-piece nipple 51 may be used in place of a two-piece nipple-collar assembly (not shown). [0078] FIG. 1G shows a bottle 10 mated to a nipple-collar assembly 50 , forming a bottle assembly 60 . Open end 13 is inserted into opening 33 , and threads 15 are engaged with threads 34 . Open end 13 and flange 21 , held together with pressure from flange 35 , form a liquid-proof seal. [0079] FIG. 1H shows a section of an optional prior art cover 52 , which is formed of plastic. Cover 52 has an open end 53 with opening 54 . Cover 52 has a closed end 55 , with a centrally located recess 56 on the interior side. Cover 52 has a side 57 with an inward retaining rib 58 . [0080] FIG. 1I shows a section of a cover 52 mated to a bottle assembly 60 (see FIG. 1J ). Recess 56 conforms to and covers closed end 24 . [0081] FIG. 1J shows the details of retaining a cover 52 on a collar 30 . An inward retaining rib 58 on cover 52 is engaged with an outward retaining rib 37 on collar 30 , forming a snap closure. [0082] A one-piece example of the invention is shown in FIGS. 2A to 2 D. A container insert 100 ( FIG. 2A ) of hollow construction, cylindrical in shape, formed of plastic, preferably transparent, with a plurality of graduations 70 on the outside. Container insert 100 has an outer wall 101 ( FIG. 2B ), closed off at closed end 102 , with an opening 105 at open end 104 . Outer wall 101 is curved slightly inward at open end 104 ( FIGS. 2B and 2C ). Outer wall 101 has a plurality of slight castellations 72 with rounded corners 73 along the edge of opening 105 ( FIG. 2C ). Container insert 100 can be filled with a material 62 through opening 105 ( FIG. 2D ). [0083] FIGS. 2E to 2 G show a one-piece container insert 100 in use. Container insert 100 , filled with a material 62 , is mated with a nipple-collar assembly 50 by inserting open end 104 into opening 26 ( FIG. 2E ). A liquid-proof seal is created by open end 104 and neck 22 , protecting material 62 . Nipple-collar assembly 50 , with container insert 100 and material 62 , is mated to a bottle 10 , which also contains a liquid 61 ( FIG. 2F ). This is the storage position for container insert 100 . Liquid 61 and material 62 cannot communicate and may be stored separately in this configuration, ready for mixing, for as long as the sterility of the environment in which it was prepared allows. When mixing is desired, nipple 20 is depressed with enough force to dislodge container insert 100 from nipple 20 ( FIG. 2G ). Open end 104 is unsealed, allowing material 62 and liquid 61 to mix through opening 105 . After agitating bottle assembly 60 the mixture can be administered. [0084] A two-piece example of the invention is shown in FIGS. 3A to 3 E. A container insert assembly 250 ( FIG. 3A ), comprising an insert body 200 of hollow construction, cylindrical in shape, formed of plastic, preferably transparent, with a plurality of graduations 70 on the outside, and a sealing member 210 shaped like a cap. Insert body 200 has an outer wall 201 ( FIG. 3B ), with an opening 203 at open end 202 and an opening 205 at open end 204 . Outer wall 201 is curved slightly inward at open end 204 ( FIGS. 3B and 3C ). Outer wall 201 has a plurality of slight castellations 72 with rounded corners 73 along the edge of opening 205 ( FIG. 3C ). Sealing member 210 is attached to insert body 200 at open end 202 ( FIG. 3D ). Sealing member 210 has a side 211 ( FIG. 3E ) with an inward rib 212 , which engages with an outward rib 208 on outer wall 201 at open end 202 , forming a removable liquid proof snap closure. [0085] FIGS. 3F to 3 J show a two-piece container insert assembly 250 in use. An insert body 200 is mated with a nipple-collar assembly 50 by inserting open end 204 into opening 26 ( FIG. 3F ), forming a liquid-proof seal between open end 204 and neck 22 . Insert body 200 and nipple-collar assembly 50 are inverted, and a material 62 is added through opening 203 ( FIG. 3G ). A sealing member 210 is attached to insert body 200 at open end 202 , forming a container insert assembly 250 ( FIG. 3H ), and with nipple-collar assembly 50 material 62 is sealed. Nipple-collar assembly 50 , with container insert assembly 250 and material 62 , is mated to a bottle 10 , which also contains a liquid 61 ( FIG. 3I ). This is the storage position for container insert assembly 250 . Liquid 61 and material 62 cannot communicate and may be stored separately in this configuration, ready for mixing, for as long as the sterility of the environment in which it was prepared allows. When mixing is desired, nipple 20 is depressed with enough force to dislodge container insert assembly 250 from nipple 20 ( FIG. 3J ). Open end 204 is unsealed, allowing material 62 and liquid 61 to mix through opening 205 . After agitating bottle assembly 60 the mixture can be administered. [0086] The preferred embodiment of the invention is shown in FIGS. 4A to 4 E. A container insert assembly 350 ( FIG. 4A ), comprising an insert body 300 of hollow construction, cylindrical in shape, formed of plastic, preferably transparent, with a plurality of graduations 70 on the outside, and a sealing member 310 shaped like a cap with a pushrod 315 in the inside center. Insert body 300 has an outer wall 301 ( FIG. 4B ), with an opening 303 at open end 302 and an opening 305 at open end 304 . Outer wall 301 is curved slightly inward at open end 304 ( FIGS. 4B and 4C ). Outer wall 301 has a plurality of slight castellations 72 with rounded corners 73 along the edge of opening 305 ( FIG. 4C ). Sealing member 310 is attached to insert body 300 at open end 302 ( FIG. 4D ). Pushrod 315 , with a bulb 316 on its end, is long enough to protrude from opening 305 . Outer wall 301 has a flange 308 at open end 302 ( FIG. 4E ), which seats in a groove 314 on sealing member 310 , formed by a side 312 and a flange 313 , providing a liquid-proof seal. [0087] FIGS. 4F to 4 L show a container insert assembly 350 in use. An insert body 300 is mated with a nipple-collar assembly 50 by inserting open end 304 into opening 26 ( FIG. 4F ), forming a liquid-proof seal between by open end 304 and neck 22 . Insert body 300 and nipple-collar assembly 50 are inverted, and a material 62 is added through opening 303 ( FIG. 4G ). A sealing member 310 is attached to insert body 300 at open end 302 , pushing pushrod 315 through material 62 , forming a container insert assembly 350 ( FIG. 4H ), and with nipple-collar assembly 50 , material 62 is sealed. When an optional cover 52 is attached to nipple-collar assembly 50 with container insert assembly 350 ( FIG. 41 ), closed end 24 , when slightly compressed by recess 56 , should not come in contact with pushrod 315 . Nipple-collar assembly 50 , with container insert assembly 350 and material 62 , is mated to a bottle 10 , which also contains a liquid 61 ( FIG. 43 ). This is the storage position for container insert assembly 350 . Liquid 61 and material 62 cannot communicate and may be stored separately in this configuration, ready for mixing, for as long as the sterility of the environment in which it was prepared allows. When mixing is desired, closed end 24 of nipple 20 is depressed ( FIG. 4K ), exerting enough force on pushrod 315 to dislodge sealing member 310 from insert body 300 . Open end 302 is unsealed, and material 62 and liquid 61 can mix through opening 303 . Nipple 20 is depressed further to dislodge insert body 300 from nipple 20 ( FIG. 4L ). Open end 304 is also unsealed, allowing material 62 and liquid 61 to mix through both opening 305 and opening 303 , facilitating a thorough mixing. After agitating bottle assembly 60 the mixture can be administered. [0088] A three-piece example of the invention is shown in FIGS. 5A to 5 F. A container insert assembly 450 ( FIG. 5A ), comprising an insert body 400 of hollow construction, cylindrical in shape, formed of plastic, preferably transparent, with a plurality of graduations 70 on the outside, and two sealing members 410 shaped like caps. Insert body 400 has an outer wall 401 ( FIG. 5B ) with an opening 403 at each end. Outer wall 401 has a plurality of slight castellations 406 along the edge of each opening 403 ( FIG. 5C ). Each sealing member 410 has a side 412 with a plurality of slight castellations 416 ( FIG. 5D ). Sealing members 410 are attached to insert body 400 at each end ( FIG. 5E ). Outer wall 401 has a flange 408 at both ends, each which seats in a groove 414 on a sealing member 410 ( FIG. 5F ), formed by side 412 and a flange 413 , providing a liquid-proof seal. Each sealing member 410 has a fin 415 on the outside. [0089] FIGS. 5G to 5 J show the three-piece container insert assembly 450 in use. An insert body 400 is mated with a sealing member 410 at one end, and filled with a material 62 through the other ( FIG. 5G ). A second sealing member 410 is mated to the open end of insert body 400 , forming a container insert assembly 450 ( FIG. 5H ) and sealing material 62 . Container insert assembly 450 , with material 62 , is placed inside a bottle assembly 60 , which also contains a liquid 61 ( FIG. 5I ). This is the storage position for container insert assembly 450 . Liquid 61 and material 62 cannot communicate and may be stored separately in this configuration, ready for mixing, for as long as the sterility of the environment in which it was prepared allows. When mixing is desired, bottle assembly 60 is shaken with enough force to dislodge each sealing member 410 from insert body 400 ( FIG. 5J ). The ends of insert body 400 are unsealed, allowing material 62 and liquid 61 to mix through both openings 403 . After agitating bottle assembly 60 mixture can be administered. [0090] The container inserts can also be prepackaged for immediate use. FIG. 6A shows a container insert 100 , filled with a material 62 , with open end 104 sealed using a sealing member 74 , and enclosed in a packaging 71 . Sealing member 74 can be a cellophane diaphragm held in place using a non-permanent adhesive or heat bond such that sealing member 74 can be easily removed using a pull tab 75 . Packaging 71 can be a foil wrapper. FIG. 6B shows a container insert assembly 350 , filled with a material 62 , with open end 304 sealed using a sealing member 309 , and enclosed in a packaging 71 . Sealing member 309 , made of a suitable rigid plastic, is held in place by friction against outer wall 301 , prevents an accidental force on pushrod 315 that might dislodge sealing member 310 , and can easily be removed. FIG. 6C shows a container insert assembly 450 , filled with a material 62 , and enclosed in a packaging 71 . [0091] Accordingly, the reader will see that the container insert of this invention can be used to store a material separately inside a bottle, and release the material into the bottle when desired. Furthermore, the container insert has the additional advantages in that: it permits the caregiver to prepare the bottle in a controlled environment, facilitating cleanliness and accurate measurements; it permits the caregiver to mix the contents when desired without reopening the bottle, eliminating a significant chance of contamination; it permits the caregiver to mix the contents quickly and with minimal attention, even one handed with tactile senses only; its simple design allows ease of cleaning; it works with bottles the caregiver already possesses. [0097] Although the description above contains many specificities, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of the invention. For example, the container insert body can be made of a bag to work with prior art bag-style bottles; the container insert can be used in bottles other than for feeding infants, including geriatric, invalid, and livestock care; the insert container can be shaped differently to accommodate different bottles. [0098] Thus the scope of the invention should be determined by the appended claims and their legal equivalents, rather than by the examples given.

1a

RELATED APPLICATIONS [0001] This application hereby claims the priority of U.S. Provisional Application 61/191,140 filed on Sep. 5, 2008. U.S. Provisional Application 61/191,140 and US patent application for Ultrasonic Shears Actuating Mechanism filed on Sep. 4, 2009, US patent application for Improved Tissue Pad filed on Sep. 4, 2009, and US patent application for Ultrasonic Shears Force Limiting filed on Sep. 4, 2009 are incorporated by reference. TECHNICAL FIELD [0002] The present invention relates generally to ultrasonic surgical devices, and more particularly to ultrasonic surgical clamp coagulator apparatus for coagulating and/or cutting tissue. BACKGROUND OF THE INVENTION [0003] Ultrasonic surgical instruments are finding increasingly widespread application in surgical procedures by virtue of the unique performance characteristics of such instruments. Depending upon specific instrument configurations and operational parameters, ultrasonic surgical instruments can provide substantially simultaneous cutting of tissue and hemostasis by coagulation, minimizing patient trauma. In some ultrasonic instruments the cutting action is typically effected by an end-effector at the distal end of the instrument, with the end-effector transmitting ultrasonic energy to tissue brought into contact therewith. Ultrasonic instruments of this nature can be configured for open surgical use, or laparoscopic or endoscopic surgical procedures. [0004] Ultrasonic surgical instruments have been developed that include a clamp mechanism to press tissue against the end-effector of the instrument in order to couple ultrasonic energy to the tissue of a patient. Such an arrangement (sometimes referred to as an ultrasonic shears, ultrasonic clamp coagulator, or an ultrasonic transector) is disclosed in U.S. Pat. No. 5,322,055, incorporated herein by reference. SUMMARY OF THE INVENTION [0005] The present invention provides an ultrasonically-actuated surgical instrument for cutting/coagulating tissue, including loose and unsupported tissue, wherein the ultrasonic actuated blade is employed in conjunction with a clamp for applying a compressive or biasing force to the tissue against the blade. The present invention provides the foregoing features, in one embodiment hereof, as an ultrasonic clamp coagulator accessory for a standard ultrasonic surgical system wherein the instrument may be particularly adapted for endoscopic surgery. [0006] A standard ultrasonic surgical system comprises essentially a generator, which contains a power source for generating an ultrasonic frequency electrical drive sinusoidal waveform such as described in U.S. Pat. Nos. 5,026,387 and 6,063,050 (incorporated herein by reference) and a handpiece, containing a transducer for converting such electrical signal into longitudinal mechanical vibration for coupling to a blade assembly. Examples of suitable transducers include piezoceramic transducers as described in U.S. Pat. No. 7,285,895 (incorporated herein by reference), magnetostrictive transducers, or other means of producing ultrasonic vibration. [0007] Examples of generators include Ethicon Endo-Surgery Generator 300 or Generator G-110 and the Covidien AutoSonix Generator Box. Examples of transducers, sometimes called handpieces, include Ethicon Endo-Surgery HP054 or HPBLUE and Covidien AutoSonix™ Transducer. [0008] The clamp coagulator accessory adapts this standard ultrasonic unit for use in conjunction with a clamp assembly whereby tissue, particularly loose tissue, may be clamped between a clamping jaw and the blade for cutting and coagulating the tissue. [0009] In one embodiment, an ultrasonic surgical apparatus is configured to permit selective cutting, coagulation, and/or clamping of tissue during surgical procedures. The apparatus includes a pivoting clam arm which may be selectively pivoted towards and ultrasonic end effector. During use, tissue may be compressed against the ultrasonic end-effector by the clam arm, thereby allowing the tissue to be clamped, cut, and/or coagulated. [0010] The apparatus may be configured such that the pivotal clamp arm of the clamping mechanism is maintained in substantial alignment with the ultrasonic end-effector. Recognizing that normal manufacturing tolerances can result in misalignment of the clamp arm and end-effector, one embodiment of the present invention includes a clamp arm mounting arrangement which provides a “self-centering” action which maintains the clamp arm in the desired alignment with the ultrasonic end-effector. This desired alignment is achieved even when components of the apparatus, including the pivotal clamp arm, are dimensioned within normal manufacturing tolerances. [0011] In accordance with one embodiment, the present surgical apparatus includes a housing, and an inner tubular sheath having a proximal end joined to the housing. The inner tubular sheath may be joined with the housing in a manner which allows for rotation of the inner tubular sheath relative to the housing. An outer actuating member is reciprocably positioned around the inner tubular sheath such that the outer actuating member may reciprocally move longitudinally along the inner tubular sheath. An operating lever may be mounted on the housing and configured to effect selective reciprocable movement of the outer actuating member with respect to the inner tubular member. [0012] An ultrasonic waveguide, or blade, is positioned within the inner tubular sheath, and includes an end-effector extending distally of a distal end of the outer tubular sheath. In order to couple tissue with the ultrasonic end-effector, the apparatus includes a clamp arm pivotally mounted on the distal end of the inner tubular sheath for pivotal movement with respect to the end-effector. In this fashion, tissue can be clamped between the clamp arm and the end-effector for creating the desired ultrasonic effect on the tissue. The clamp arm is also operatively connected to the outer actuating member so that reciprocable movement of the outer actuating member pivotally moves the clamp arm with respect to the end-effector. [0013] In one embodiment, a rotating member such as a spline knob may be mounted on the housing in order to allow the user to align the blade and other components. For example, notches may be located on the inside of a spline knob engage openings on the inner and outer tube and on the blade shaft to ensure rotational alignment of the said inner tube and outer tube with the blade. Said spline knob serves as a means of rotating said blade to achieve desired alignment. Said notches may be oriented with respect to the blade end-effector to adjust the orientation of the blade with respect to the clamp arm. [0014] In one embodiment, the clamp is actuated by a scissor-like grip created by a thumb lever movably located on the under side of the handle housing and a finger grip located at the proximal end of the ultrasonic wave guide. Said thumb lever may be connected to a metal lever extending upwards towards the waveguide. The metal lever may be connected to a yoke assembly that engages the slideable outer tube, thereby allowing proximal and distal sliding movement of the thumb lever to slide the outer tube proximally and distally respectfully. [0015] A pin may be received through a distal end portion of the outer tube to engage a flat or a curved camming portion of the proximal end of the clamp arm. Distal motion of the slideable outer tube creates a camming motion acting upon said clamp arm. Furthermore, the clamp arm may be pivotally mounted via two mounting pins located at opposite side of the proximal end of said clamp along the circumference near the center of the distal end of the non-slideable inner tube so that the motion of the pin on the camming surface results in an opening and closing of the jaw with respect to the ultrasonic blade. [0016] This camming surface of the clamp arm may be distal or proximal to said clamp arm pivot, improving alignment between the clamp arm and blade. Thus, in one embodiment, by significantly reducing or eliminating relative motion between the inner tube and the blade, damage and failures of the blade seal can be reduced or eliminated. [0017] In one embodiment, a yoke assembly may be provided and includes a force-opposing member that engages a pre-loaded force-limiting spring. When said movable thumb lever moves distally, moving the clamp arm into a clamped position, said metal lever engages the force-opposing member, engaging the force-limiting spring, thus preventing adverse forces from being applied to the jaw. [0018] In accordance with one embodiment of the present invention, the outer tubular sheath includes a clamp arm mount, generally at the distal end thereof, on which the clamp arm is pivotally mounted. In order to maintain the clamp arm in the desired alignment with the associated end-effector, the clamp arm mount may engage the clamp arm, so as to provide a “self-centering” action in cooperation therewith. This engagement, which is accommodated by longitudinally parallel surfaces of the clamp arm and clamp arm mount, may accommodate normal manufacturing tolerances of the components, particularly the clamp arm, while maintaining the clamp arm in substantial alignment with the ultrasonic end-effector. [0019] In accordance with one illustrated embodiment, the clamp arm mount may have a generally U-shaped cross-section. The clamp arm mount includes a pair of laterally spaced leg portions which engage the clamp arm. The longitudinal parallel surfaces guide the clamp arm while opening and closing to maintain the clamp arm in substantial alignment. Each leg portion may define a respective pivot opening for receiving an associated pivot pin for pivotal mounting of the clamp arm. The clamp arm may include a pair of integral pivot pins respectively positioned on laterally spaced portions of the clamp arm. The integral pivot pins are configured for respective pivotal mounting in the pivot openings defined by the leg portions of the clamp arm mount. [0020] In one embodiment, the clamp arm holds or includes a tissue pad located substantially along the tissue side of the clamp arm, which acts as a clamping surface against the blade (i.e. the side facing the end effector of the blade). Said tissue pad may have a planar, concave, or convex tissue engagement surface. Said tissue pad may be adhered to said clamp arm by means of a glue or intermediate layer containing one or more adhesive surfaces. Said tissue pad may also attach mechanically to said clamp arm by means, for example, of molding said tissue pad into a shape with one or more columnar standoffs projecting from the tissue pad extending through the clamp arm and terminating on the opposite, outer surface of the clamp arm and comprising one or more features that are substantially larger than the columnar portion of the standoff, engaging the outer surface of the clamp arm securing the tissue pad to the clamp arm. Furthermore, the clamp arm may comprise indented features to accept said substantially larger features of said columnar standoffs, further securing the tissue pad to the clamp arm. Said tissue pad may also attach mechanically to said clamp arm via a substantially V-shaped or T-shaped slot located on the tissue engaging side of said clamp arm. Said tissue pad may comprise a substantially V-shaped or T-shaped projection that would engage said V-shaped or T-shaped slot. Furthermore, said tissue pad may comprise one or more curved tissue stop pads located proximally from the parallel tissue engaging surface of the tissue pad. Said curved tissue stop pads may curve from a direction parallel to the blade engaging surface of said tissue pad to a direction greater than 30 degrees from parallel and preferably substantially perpendicular to the orientation of the blade and act as an additional tissue grasping and manipulating surface. [0021] Other features and advantages of the present invention will become readily apparent from the following detailed description, the accompanying drawings, and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0022] FIG. 1 is a perspective view of an ultrasonic surgical instrument system. [0023] FIG. 2 is a side view of one embodiment of ultrasonic shears disclosed herein. [0024] FIG. 3 is a perspective view of the ultrasonic shears of FIG. 2 . [0025] FIG. 4 is a side section view of the ultrasonic shears of FIG. 2 . [0026] FIG. 5 is a detailed side view of the housing of the ultrasonic shears of FIG. 2 , with the left housing removed. [0027] FIG. 6 is a side view of the ultrasonic shears of FIG. 2 . [0028] FIG. 7 is a side view of one embodiment of the end-effector of the ultrasonic shears of FIG. 2 . [0029] FIGS. 8A and 8B are side section views of the end-effector of FIG. 7 . [0030] FIGS. 9A and 9B are perspective section views of the end-effector of the ultrasonic shears disclosed herein. [0031] FIGS. 10A and 10B are perspective section views of the end-effector of the ultrasonic shears disclosed herein. [0032] FIGS. 11 through 13 show the motion of the ultrasonic shears instrument including the force-limiting mechanism disclosed herein. [0033] FIG. 14A is a perspective view of the end-effector, actuating tube, spline knob assembly disclosed herein. [0034] FIG. 14B is a perspective view of the spline knob assembly with one half of the spline knob removed. [0035] FIG. 14C is a side view of the spline knob assembly with one half of the spline knob removed. [0036] FIGS. 15A and 15B are section views of the spline knob assembly disclosed herein. [0037] FIGS. 16 and 17 are exploded perspective views of the ultrasonic shears instrument disclosed herein. [0038] FIGS. 18A , 18 B, and 18 C are side, bottom and isometric views of a clamp arm with tissue gripping feature [0039] FIGS. 19A and 19B are side and isometric views of an end effector with clamp arm containing a compliance member. [0040] FIGS. 20A and 20B are a side view and a perspective view, respectfully, of an ultrasonic instrument end effector including tissue pad securing features. [0041] FIGS. 21A , 21 B, and 21 C are a side view, a top view, and a section view, respectfully, of a clamp arm including tissue pad securing features. [0042] FIGS. 22A , 22 B, and 22 C are a side view, a top view, and a section view, respectfully, of a clamp arm including tissue pad securing features [0043] FIGS. 23A and 23B are a side view and a perspective view, respectfully, of a clamp arm including tissue grasping features. [0044] FIGS. 24A and 24B are a side view and a perspective view, respectfully, of a clamp arm including tissue pad securing features. [0045] FIGS. 25A and 25B are a side view and a perspective view, respectfully, of a clamp arm including tissue grasping features [0046] FIG. 26 is a cross section view of a clamp arm including tissue grasping features [0047] FIG. 27 is a list of all elements described herein. DETAILED DESCRIPTION OF THE INVENTION [0048] The present invention will be described in combination with ultrasonic instruments as described herein. Such description is exemplary only, and is not intended to limit the scope and applications of the invention. [0049] FIG. 1 illustrates one embodiment of an ultrasonic system 10 for coagulating and/or cutting tissue. Ultrasonic system 10 may comprise an ultrasonic signal generator 50 , an ultrasonic transducer 20 , ultrasonic surgical apparatus 30 . In the embodiment shown in FIG. 1 , ultrasonic surgical apparatus 30 is configured as ultrasonic shears for cutting and coagulating tissue. A torque tool 40 which may be used to secure ultrasonic shears 30 to ultrasonic transducer 20 is also shown in FIG. 1 . [0050] FIGS. 2 and 3 further illustrate one embodiment of ultrasonic shears 30 . Ultrasonic shears 30 comprise a housing 65 , which may include a right housing 60 and a left housing 70 . Proximal of said housing is a movable thumb lever 110 , the thumb lever distal motion 420 of which is shown. Rotational movement 630 is also shown allowing for alignment of the end effector 176 during use. Clamp arm closing motion 620 is illustrated and is resultant of said thumb lever distal motion. [0051] FIG. 4 is a partial section view of ultrasonic shears 30 , illustrating the securing of ultrasonic transducer 20 onto the ultrasonic shears. In the embodiment shown, ultrasonic blade 220 is secured to transducer 20 using a threaded connection. This permits the transmission of ultrasonic vibration from ultrasonic transducer 20 to ultrasonic blade 220 . Alternative connection means providing a secure interface between ultrasonic transducer 20 and ultrasonic blade 220 may also be used. [0052] FIG. 5 illustrates the handle portion of shears 30 with left housing 70 hidden to reveal the inner workings. Shown is the right housing 60 of the ultrasonic shears 30 , which includes finger grip 112 . Finger grip 112 and thumb lever 110 create a scissor grip movably located on the under side of the right handle housing 60 . Said thumb lever 110 connects to a linkage 80 operably connected to a yoke assembly 90 that engages the actuating outer tube 230 , thereby allowing proximal lever motion 410 and distal lever motion 420 of the thumb lever 110 to slide the outer tube with a proximal motion 510 and distal motion 520 respectively (see FIG. 6 ). The yoke assembly 90 may include a force-opposing member 100 that engages a pre-loaded force-limiting spring 130 . Drive flange 140 transfers force from said yolk assembly to the outer actuating tube 230 . Spline knob 180 acts as a means of rotating shaft assembly 240 and thus ultrasonic blade 220 to achieve desired alignment. Sleeve 200 houses and compresses the distal portion of said spline knob 180 . Washer 190 acts as a rotation and thrust bearing for shaft assembly 240 and prevents backlash. [0053] FIG. 6 is a side view of the ultrasonic shears 30 , illustrating the relationship between the motion 400 of thumb lever 110 relative to the outer actuating tube 230 , clamp arm 150 , tissue pad 170 and the ultrasonic blade 220 . Proximal motion 410 of thumb lever 110 results in proximal motion 510 of outer actuating tube 230 , which results in the opening motion 610 of the clamp arm 150 relative to the ultrasonic blade 220 . Conversely, distal motion 420 of said thumb lever 110 results in distal motion 520 of said outer actuating tube 230 , which results in the closing motion 620 of said clamp arm 150 and tissue pad 170 relative to said ultrasonic blade 220 . [0054] FIG. 7 is a side closeup view of the end-effector 176 of the ultrasonic shears 30 . Outer actuating tube 230 operably connects to clamp arm 150 via actuating pin 232 . Non-actuating inner tube 160 is shown extending distally from inside said outer actuating tube 230 . Inner tube 160 remains stationary with respect to ultrasonic blade 220 and blade seal 222 (see FIG. 8A ). Tissue pad 170 is shown connected to said clamp arm 150 to operably contact with ultrasonic blade 220 and tissue therebetween when in surgical use. Furthermore, said tissue pad 170 may comprise one or more tissue stop pads 172 located proximally from the blade engaging surface 174 of the tissue pad 170 . The tissue stop pads 172 may curve from a direction parallel to the blade engaging surface 174 of said tissue pad 170 to a direction between 30 degrees and substantially perpendicular to the orientation of the ultrasonic blade 220 and act to position and manipulate tissue and may act as an initial barrier to prevent tissue from engaging undesired portions of the blade 220 or clamp arm 150 during surgical use. Blade engaging surface 174 may be convex and/or conformal to blade end effector 178 . [0055] In one embodiment, tissue stop pads 172 may engage tissue while clamp arm 150 is in the open position. As clamp arm 150 closes, tissue stop pads 172 force the tissue in contact with the tissue stop pads 172 distally and downward against ultrasonic blade 220 . This stretches tissue across ultrasonic blade 200 , creating tension in the tissue for use when cutting and/or coagulating. Tissue tension aids in the speed of cutting and coagulation. [0056] FIGS. 8A and 8B are side partial section views of the end effector 176 of the ultrasonic shears. FIG. 8A shows the end effector 176 with the clamp arm 150 in the open position. FIG. 8B shows the end effector 176 with clamp arm 150 in the closed position. Clamp arm 150 rotatably attaches via pivot pin 152 to non-actuating inner tube 160 . The axis of pivot pin 152 may be positioned above, below, or passing through the axis of ultrasonic blade 220 . Clamp arm 150 pivots about pivot pin 152 when outer actuating tube 230 slides distally or proximally, engaging actuating pin 232 which is mounted at the substantially distal end of the outer actuating tube 230 and extending through cam slot 154 and operably engaging cam surface 156 . Ultrasonic blade 220 extends through the interior of tube 160 and is engaged by tissue pad 170 which is connected to clamp arm 150 to facilitate clamping tissue between tissue pad 170 and ultrasonic blade 220 . If tissue stop pads 172 are positioned near ultrasonic blade 220 , they may perform a wiping action, clearing said ultrasonic blade of tissue upon opening and closing of clamp arm 150 . [0057] The profile and location of cam slot 154 and cam surface 156 may be selected to provide constant or variable mechanical advantage as actuating pin 232 moves distally or proximally. As clamp arm 150 rotates, the contact angle between cam surface 156 and actuating pin 232 provides a quantifiable mechanical advantage that can be chosen to meet the requirements for manipulating tissue for the position of clamp arm 150 . The profile of cam surface 156 may be straight, contain one or more curves, or any combination thereof. Cam surface 156 may also include indentions or protuberances to give sensory feedback as actuating pin moves along the surface. Cam slot 154 may be placed distal or proximal to pivot pin 152 . [0058] In one embodiment, a steeper angle with respect to the motion of actuating pin 232 will provide faster clamp arm 150 closing speed with lower mechanical leverage, while a shallower angle will provide slower clamp arm 150 closing speed with higher mechanical leverage. When outer actuating tube 230 is positioned as shown in FIG. 8A , the contact angle is steep, providing faster closing speed than when outer actuating tube 230 is positioned as shown in FIG. 8B . However, the mechanical advantage is greater in FIG. 8B , allowing significant clamping force to be applied to tissue. [0059] In one embodiment, actuating pin 232 may be mounted at the substantially distal end of an inner actuating tube and extending through cam slot 154 and operably engaging cam surface 156 . Clamp arm 150 rotatably attaches via pivot pin 152 to non-actuating outer tube. Clamp arm 150 pivots about pivot pin 152 when inner actuating tube slides distally or proximally, engaging actuating pin 232 . [0060] FIGS. 9A , 9 B, 10 A, and 10 B are alternate partial sectional views of said end effector 176 of said ultrasonic shears 30 . Shown is blade seal 222 , which does not move with respect to blade 220 and inner tube 160 . Blade seal 222 may be bonded to ultrasonic blade 220 or inner tube 160 . Alternately, blade seal 220 may be held in place through mechanical means. Reducing or eliminating the relative motion of blade seal 222 with respect to ultrasonic blade 220 and inner tube 160 allows for a tighter seal and reduces wear. This further reduces potential fluid migration along the shaft of blade 220 inside inner tube 160 . Fluid along the shaft of blade 220 can produce unwanted and potentially dangerous heat as ultrasonic energy is damped out by the fluid. Reducing fluid migration reduces parasitic diversion of ultrasonic energy from blade 220 into waste heat, which can result in patient injury in some circumstances. By moving actuating tube 230 rather than inner tube 160 , the risk of patient injury can be reduced. Seal integrity is further enhanced by locating blade seal 222 with respect to blade 220 and inner tube 160 during manufacture of ultrasonic shears 30 . [0061] FIGS. 11A and 11B illustrate partial section views of the ultrasonic shears 30 . The clamp arm 150 is actuated by a scissor-like grip created by a thumb lever 110 movably located on the under side of the right handle housing 60 and finger grip 112 located at the proximal end of the ultrasonic blade 220 . Said thumb lever connects to a linkage 80 operably connected to yoke assembly 90 that engages the actuating outer tube 230 , thereby allowing proximal and distal sliding movement of the thumb lever to slide the outer tube proximally and distally respectfully, resulting in the opening and closing movement of said clamp arm. [0062] FIGS. 12A and 12B further illustrate the actuating motion of the ultrasonic instrument. Said elements described above actuate upon living tissue 300 in the manner described. Relative motion of finger grip 112 with respect to lever 110 produces motion in clamp arm 150 with respect to blade 220 . In the embodiment shown, distal motion 420 of thumb lever 110 results in distal motion 520 in outer actuating tube 230 producing closing motion 620 of clamp arm 150 and tissue pad 170 , thereby compressing tissue 300 against blade 220 . [0063] FIGS. 13A and 13B further illustrate the yoke assembly 90 which includes a force-opposing member 100 that engages a pre-loaded force-limiting spring 130 . When slideable thumb lever 110 moves distally, moving said clamp arm 150 into a clamped position, linkage 80 engages the force-opposing member, engaging the force-limiting spring, thus preventing adverse forces from being applied to the clamp arm or the tissue 300 shown clamped between said clamp arm and said ultrasonic blade. Continued distal motion 420 on thumb lever 110 results in spring compression 132 , limiting the force applied to tissue 300 . By careful selection of the point of farthest travel by the said actuating tube and the preload of the said force-limiting spring 130 , the tissue can be compressed and transected with a clamping force within a desirable range. [0064] In one embodiment, force-limiting spring 130 is a helical spring. Force limiting spring 130 may also be any of the following types of springs: a cantilever, coil, conical, volute, leaf, V-spring, Belleville, disc, constant-force, gas, mainspring, elastomeric, washer, torsion, extension, wave or other deformable component. [0065] FIG. 14A illustrates the shaft assembly 240 of one embodiment of the ultrasonic shears apparatus. Drive flange 140 transfers force from the above-described yolk assembly to the outer actuating tube 230 . Spline knob 180 acts as a means of rotating said shaft assembly, and thus ultrasonic blade 220 to achieve desired alignment. Sleeve 200 houses and compresses the distal portion of said spline knob. Torque tab 210 engages the torque tool 40 to secure or disconnect the ultrasonic shears instrument to the ultrasonic transducer 20 . Compliance feature 234 is created by notches which allow the outer actuator tube 230 to compress when significant axial load is applied. Notches may alternate or form a spiral pattern. By careful selection of the point of farthest travel by the said actuating tube and the preload of the said compliance feature 234 , the tissue can be compressed and transected with a clamping force within a desirable range. [0066] FIGS. 14B and 14C are a perspective view and a side view, respectfully, of one embodiment of the spline knob assembly with washer 190 , sleeve 200 , blade 200 , and one half of the spline knob 180 removed, showing torque tabs 210 . Tabs 182 located on the inside of a spline knob engage inner tube openings 186 and outer tube openings 188 on the non-actuating inner tube 160 and outer actuating tube 230 and recesses 184 on the ultrasonic blade 220 to ensure rotational alignment of the said inner tube and outer tube with the blade. Said spline knob serves as a means of rotating said blade to achieve desired alignment. Said tabs and recesses are oriented with respect to the blade end-effector 178 to adjust the orientation of the blade end effector 178 to the clamp arm. Sleeve 200 acts to house said spline knob and the blade and tube assembly as well as secure washer 190 , which acts to securely locate said shaft assembly within the ultrasonic shears instrument handle assembly. Sleeve 200 compresses said spline knob, compressing tabs 182 into recesses 184 , substantially aligning the features. Cross section 242 intersects the assembly for purposes of illustration in FIGS. 15A and 15B . [0067] FIGS. 15A and 15B illustrate cross sectional views of the spline knob assembly with outer actuating tube 230 in different positions. [0068] FIG. 16 is an exploded view of the ultrasonic shears apparatus showing some of the previously described components and subassemblies of one embodiment. [0069] FIG. 17 is an exploded view of one embodiment of the ultrasonic shears shaft assembly showing components and features unobstructed by outer components of one embodiment. [0070] FIGS. 18A , 18 B, and 18 C illustrate one embodiment of a clamp arm 150 having integral tissue grip features 158 . Clamp arm 150 and tissue pad 170 may be made from a metal and a polymer respectively. Tissue grip features 158 are designed to prevent tissue from slipping while being manipulated. Said tissue grip features may be any non-smooth surface, including but not limited to teeth, bumps, ridges, holes, and knurls. Tissue grip features 158 made from metal will withstand wear and damage better than equivalent features on a polymer tissue pad 170 . Tissue pad 170 may be attached to said clamp arm and may or may not be designed to provide additional gripping force on tissue. The width of blade engaging surface 174 of tissue pad 170 may be the same or less than the width of clamp arm 150 . [0071] FIGS. 19A and 19B illustrate an embodiment of clamp arm 150 which includes an integrated compliance member 134 . Said compliance member is operably connected to an actuator such as the outer actuating tube 230 and to said clamp arm. Said compliance member deforms when force is applied by said outer actuating tube, reducing the closing motion 620 when resistance is met. Said outer actuating tube is prevented from traveling beyond a set point, limiting the force that may be applied to said clamp arm. Said compliance member may be preloaded to prevent deformation until the said applied force is above a threshold. By careful selection of the point of farthest travel by the said actuating tube and the preload of the said compliance member 134 , the tissue can be compressed and transected with a clamping force within a desirable range. [0072] FIGS. 20A and 20B illustrate an embodiment of an end effector 176 with a clamp arm 150 with a tissue pad 170 connected to said clamp arm via one or more tissue pad rivets 350 extending through the cross-sectional area of said clamp arm, terminating on the side opposite of tissue interaction of said tissue pad of said clamp arm. Said tissue pad rivets, for example, can be molded or inserted through said clamp arm and then heat processed so that said tissue pad rivets form a substantially larger, opposing surface on said side opposite of tissue interaction. [0073] FIGS. 21A through 21C illustrate an embodiment of clamp arm 150 which includes tissue pad rivets 350 . Cross section 352 is shown in FIG. 21C . [0074] FIGS. 22A through 22C illustrate an embodiment of clamp arm 150 which includes a tissue pad 170 including tissue pad connection member 360 extending substantially longitudinally along the length of said clamp arm and through the cross-sectional area of said clamp arm, terminating on the side opposite of tissue interaction of said tissue pad of said clamp arm. Said tissue pad connection member forms an enlarged, substantially flattened, opposing surface on said side opposite of tissue interaction. Cross section 362 is shown in FIG. 22C . [0075] FIGS. 23A and 23B illustrate an embodiment of clamp arm 150 which includes a tissue pad 170 including clamp arm projections 370 located on the surface of clamp arm 150 . Said clamp arm projections project through tissue pad 170 and may secure it through friction or mechanical interference. Said clamp arm projections also may interact with tissue creating an improved means of gripping tissue. [0076] FIGS. 24A and 24B illustrate an embodiment of clamp arm 150 which includes a tissue pad 170 secured to said clamp arm via one or more opposing tissue pad securing tabs 380 located along the length of said clamp arm. Said tissue pad securing tabs also may interact with tissue creating an improved means of gripping tissue. [0077] FIGS. 25A and 25B illustrate an embodiment of clamp arm 150 which includes tissue pad 170 located between tissue grip features 158 located along the length of said clamp arm. [0078] FIG. 26 shows cross section 392 . The width of blade engaging surface 174 of tissue pad 170 may be the same or less than the width of clamp arm 150 . Tissue pad 170 is held in place by means of a slot feature 390 . [0079] FIG. 27 is a list of all elements described herein. [0080] Thus, the described embodiments are to be considered in all aspects only as illustrative and not restrictive, and the scope of the invention is, therefore, indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

1a

Latin name of the genus and species claimed: Vitis vinifera. Variety denomination: ‘SUGRAFORTYONE’. BACKGROUND AND SUMMARY OF THE INVENTION This invention relates to the discovery and asexual propagation of a new and distinct variety of grapevine, ‘Sugrafortyone’, as herein described and illustrated. The new variety was first hybridized by Michael J. Striem and evaluated by Terry A. Bacon in Wasco, Kern County, Calif. The variety was originated by controlled hybridization. The new variety ‘Sugrafortyone’ is characterized by the production of a medium sized, green, near-round berry that ripens very early in the season and has a rudimentary seed trace. The berries of ‘Sugrafortyone’ are firm, slightly juicy, have a medium sugar content and a Muscat flavor. The seed parent is the varietal selection ‘97035-209-287’ (unpatented) and the pollen parent is the varietal selection ‘97029-206-141’ (unpatented). The parent varieties were first crossed in May 2002 by Michael J. Striem. The date of first sowing was March 2003, and the date of first flowering was May 2005. The new variety ‘Sugrafortyone’ was first asexually propagated in December 2007 in Wasco, Kern County, Calif., by Michael J. Striem using hardwood cuttings. The new variety ‘Sugrafortyone’ resembles its seed parent ‘97035-209-287’ (unpatented) in that both have green berries that ripen early in the season. The new variety ‘Sugrafortyone’ differs from its seed parent in that the new variety ripens earlier in the season, starting about July 3, and has rudimentary seed trace, while the seed parent ripens mid-season, starting about July 25, and has a noticeable seed trace. The new variety ‘Sugrafortyone’ differs from its pollen parent ‘97029-206-141’ (unpatented) in that the new variety has green berries and ripens early, starting about July 3, while the pollen parent has red berries and ripens late in the season, starting about September 1. The new variety ‘Sugrafortyone’ resembles ‘Sugraone’ (U.S. Plant Pat. No. 3,106) in having green berries that ripen early in the season. The new variety ‘Sugrafortyone’ differs from ‘Sugraone’ in that the new variety has a near-round berry shape compared to an oval berry shape for ‘Sugraone’. The new variety ‘Sugrafortyone’ also resembles ‘Sugraeighteen’ (U.S. Plant Pat. No. 11,820) in having round green berries and a Muscat aroma. The new variety ‘Sugrafortyone’ differs from ‘Sugraeighteen’ in that the new variety ripens about 5 weeks earlier. The new ‘Sugrafortyone’ variety has been shown to maintain its distinguishing characteristics through successive asexual propagations by, for example, cuttings. Variations of the usual magnitude from the characteristics described herein may occur with changes in any of a variety of factors such as growing conditions, irrigation, fertilization, pruning, management and with climatic variation. BRIEF DESCRIPTION OF THE DRAWING The accompanying color photographic illustration shows typical specimens of the foliage and fruit of the present new grape variety ‘Sugrafortyone’. The illustration shows the upper and lower surface of the leaves and exterior and sectional view of the fruit. The photographic illustration was taken shortly after the fruit was picked and the colors are as nearly true as is reasonably possible in a color representation of this type. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Throughout this specification, color names beginning with a small letter signify that the name of that color, as used in common speech, is aptly descriptive. Color names beginning with a capital letter designate values based upon The R.H.S. Colour Chart, published by The Royal Horticultural Society, London, England (2000). Many of the description values in this specification are based on and conform to those set forth by the International Board for Plant Genetic Resources Institute Grape Descriptors ( Vitis spp.) of 1983 and/or 1997, which was developed in collaboration with the Office International de la Vigne et du Vin (OIV) and the International Union for the Protection of New Varieties of Plants (UPOV). The descriptive matter which follows pertains to ‘Sugrafortyone’ plants grown in the vicinity of Wasco, Kern County, Calif. during 2011, and is believed to apply to plants of the variety grown under similar conditions of soil and climate elsewhere. VINE General: Planting .—Trained to a modified gable trellis, planted in about 7 ft.×12 ft. spacing. Practices .—Gene-pool-vine: Cane pruned to approximately 36 spurs per vine. Test-vines: Cane pruned to approximately 36 spurs per vine. Size .—Medium. Height: Approximately 2.0 m. Width: Approximately 2.2 m. Vigor .—Vigorous. Fresh pruning weight .—Approximately 7 kg per vine. Density of foliage .—Dense. Productivity .—Very productive — approximately 40 clusters per vine after thinning. Yield .—Approximately 24 kg per vine. Crop load .—Approximately 3.4 kg per vine (kg fruit per kg fresh-pruning-weight). Root stock .—Not applicable. Own root .—Yes. Resistance .—Neither resistance nor susceptibility to diseases or pests has been observed in this variety. Trunk: Shape .—Circular. Diameter .—Approximately 89 mm. Straps .—Short. Surface texture .—Shaggy. Inner bark color .—Near Dark Grey Orange 165A. Outer bark color .—Near Dark Greyed-green 197A and Near Medium Grey 201A. SHOOTS Young shoot: Form of tip .—Half open. Distribution of anthocyanin coloration of tip .—Striped. Intensity of anthocyanin coloration of tip .—Weak. Density of prostrate hairs on tip .—Medium. Density of erect hairs on tip .—Absent. Woody shoot (mature canes): Shape .—Slender. Internode length .—Approximately 62 mm. Width at node .—Approximately 12 mm. Cross section .—Circular. Surface .—Smooth. Main color .—Light brown, about Medium Greyed-Orange 164B to Near Light Greyed-Yellow 161A. Lenticels .—Absent. Density of erect hairs on nodes .—Absent or Very Sparse. Density of erect hairs on internodes .—Absent or Very Sparse. Growth of auxiliary shoots .—Medium; Average 19.5 cm/shoot. Flowering shoot: Vigor during flowering .—Strong. Attitude during flowering on shoots which are not tied .—Semi-erect. Color of dorsal side of internodes .—green with red highlights, about Medium Yellow-Green 144A and Dark Greyed-Purple 187A. Color of ventral side of internodes .—green with red highlights, about Medium Yellow-Green 144A and Dark Greyed-Purple 187A. Color of dorsal side of nodes .—green with red highlights, about Medium Yellow-Green 144A and Dark Greyed-Purple 187A. Color of ventral side of nodes .—green with red highlights, about Medium Yellow-Green 144A and Dark Greyed-Purple 187A. Density of erect hairs on nodes .—Absent. Erect hairs on internode .—Absent. Density of prostrate hairs on nodes .—Absent. Density of prostrate hairs on internodes .—Absent. Anthocyanin coloration of buds .—Absent. Tendrils: Distribution on the shoot at full flowering .—Discontinuous. Thickness .—Medium. Color .—Near Medium Yellow-Green 144C. Form .—Bifurcated. Number of consecutive tendrils .—Up to 2. Length of tendril .—Long, approximately 19 cm. LEAVES Young Leaves: Color of upper surface of first 4 distal unfolded leaves .—Near Yellow-Green 145A. Average intensity of anthocyanin coloration of six distal leaves prior to flowering .—Absent. Density of prostrate hairs between veins at lower surface of 4 th distal unfolded leaf .—Absent. Density of erect hairs between veins at lower surface of 4 th distal unfolded leaf .—Absent. Density of prostrate hairs on veins at lower surface of 4 th distal unfolded leaf .—Absent. Density of erect hairs on veins at lower surface of 4 th distal unfolded leaf .—Absent. Mature leaves: Average length .—Approximately 143 mm from ending of petiole to tip of leaf. Average width .—Approximately 190 mm. Size of blade .—Medium. Shape of blade .—Pentagonal. Number of lobes .—Approximately 5. Anthocyanin coloration of main veins on the upper side of the blade .—Absent. Mature leaf profile .—Flat. Blistering surface of blade upper surface .—Absent. Leaf blade tip .—In the plane of the leaf. Undulation of margin .—Slight. Thickness .—Medium. Undulation of blade between main and lateral veins .—Absent. Shape of teeth .—Both sides rectilinear in most cases with some convex shaped. Length of teeth .—Medium, usually 5 to 15 mm, average 10 mm. Ratio length/width of teeth .—Small. General shape of petiole sinus .—Slightly open. Tooth at petiole sinus .—Absent. Petiole sinus limited by veins .—Absent. Shape of upper lateral sinus .—Open. Depth of upper lateral sinus .—Very Shallow. Density of prostrate hairs between veins on lower surface of blade .—Absent. Density of erect hairs between veins on lower surface of blade .—Absent. Density of prostrate hairs on main veins on lower surface of blade .—Absent. Density of erect hairs on main veins on lower surface of blade .—Absent. Density of prostrate hairs on main veins on upper surface of blade .—Absent. Autumn coloration of leaves .—Dark Green, about 135A, to Medium Yellow, about 11B, to Reddish-Brown, about 178C, in late November. Upper surface: Color .—Near Dark Green 135A. Surface texture .—Smooth. Surface appearance .—Semi-Glossy to Dull. Glossiness .—Weak. Pubescence .—Absent. Lower surface: Color .—Near Medium Green 135C. Anthocyanin coloration of main veins on lower leaf surface .—Absent. Glossiness .—Weak. Pubescence .—Absent. Surface texture .—Smooth. Surface appearance .—Dull. Petiole: Length of petiole .—Medium, Approximately 10 cm. Length of petiole compared to middle vein .—Much shorter. Diameter .—Approximately 4 mm. Density of prostrate hairs on petiole .—Absent. Density of erect hairs on petiole .—Absent. Shape of base of petiole sinus .—U-shaped. Color .—Light Green 142A to Light Green 142C with highlights of Medium Greyed-Red 182B. Buds: Shape .—Conical. Size .—Medium, approximately 3 mm×4 mm. Position .—Slightly held out. Cane bud fruitfulness .—Basal most fruitful, 3 rd to 5 th bud position. Time of bud burst .—Early, about March 8th. FLOWERS General: Flower sex .—Hermaphrodite. Length of first inflorescence .—Medium, about 18 cm. Position of first flowering node .—Fifth node. Number of inflorescences per shoot .—Approximately 1 to 2. Date of full bloom .—Approximately May 5th. Size ( diameter of fully open flower ).—Medium, approximately 6 mm. FRUIT General: Ripening period .—Early, approximately July 3-14. Use .—Table grape fresh consumption. Keeping quality .—Good. Shipping quality .—Good. Date of first harvest .—Approximately July 3rd. Solids - sugar .—Medium. Refractometer test .—Approximately 17%. Acid .—Medium, approximately 0.55 gr./L tartaric acid. Juice pH .—Approximately 3.4. Tendency to crack .—Low. Sensitivity to sunburn .—Absent. Fruit shrivel after ripe .—Only when drying to raisins. Secondary cluster .—Occasional. Resistance .—Absent. Cluster: Bunch size ( peduncle excluded ).—Medium. Bunch length ( peduncle excluded ).—Medium, approximately 19 cm. Bunch width .—Approximately 16 cm. Bunch weight .—Medium, approximately 450 g. Bunch density .—Medium. Number of berries .—Approximately 85. Form .—Conical-shaped. Peduncle: Length of peduncle .—Medium, approximately 40 mm. Lignification of peduncle .—Medium. Color .—Near Medium Green 141C. Berry: Size .—Medium. Uniformity of size .—Slightly variable. Berry weight .—Medium, approximately 5.1 gr. treated. Gibberellic acid treated .—High, 20 ppm for sizing Shape .—Somewhat round. Presence of seeds .—Rudimentary. Cross section .—Round. Dimensions .—Longitudinal axis: Approximately 21 mm treated. Horizontal axis: Approximately 20 mm treated. Skin color ( without bloom ).—Near Medium Yellow-Green 149A, becoming more yellow as it ripens to near Light Yellow-Green 154A. Flesh color .—Near Light Yellow-Green 154D. Juiciness of flesh .—Slightly juicy. Berry firmness .—Firm. Particular flavor .—Muscat. Bloom ( cuticular wax ).—Medium. Pedicel length .—Medium, approximately 7.0 mm. Berry separation from pedicel .—Medium. Visibility of hilum .—Visible. Skin: Thickness .—Medium. Texture .—Smooth. Reticulation .—Absent. Roughness .—Absent. Tenacity .—Tenacious to flesh. Seed: Number of seeds per berry .—Usually 1, sometimes 2. Size .—Small. Color .—Near Light Yellow-Green 154C. Texture .—Medium. Endosperm .—Slight. Fresh weight of seed - traces/berry .—Approximately 2.47 mg. Room - dry weight of seed - traces/berry .—Approximately 1.55 mg.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of U.S. application Ser. No. 13/988,944, filed on Oct. 16, 2013, which is the National Stage of PCT/GB/2011/052253 filed on Nov. 18, 2011, which claims priority to British Patent Application Nos. GB 1019462.9 filed on Nov. 18, 2010, and GB 1112332.0 filed on Jul. 18, 2011, all of which are hereby incorporated by reference in their entireties. BACKGROUND [0002] 1. Field [0003] The present invention relates to a rescue descender system primarily, but not exclusively for use in fall arrest or fall safety systems for personnel safety when working at height. [0004] 2. State of the Art [0005] Fall arrest or fall safety systems are known in which personnel working at height are secured to a safety line in order to arrest a fall, should this occur. Such safety lines can comprise a self retracting lifeline which includes a safety block secured to an anchor point and a safety line which pays out as the user moves away from the safety block. A brake device engages to prevent paying out of the safety line in the event of a fall. Typically the system includes an energy absorption device arranged to absorb the energy of the fall when the line payout stops in order to arrest the fall. [0006] Typically, in the circumstances of a fall, the user can be left suspended in mid air. In order to be rescued, the user can be hooked from above by a rescuer (if in reach and accessible), or a rescuer can descend to the individual to attach them to a rescue line. Alternatively, devices have been proposed to enable a suspended user to self instigate lowering to ground or rescue level. Such arrangements are disclosed in, for example, GB2414005 and WO2009/027619. Such systems can be referred to as self rescue devices. [0007] GB2414005 discloses a rescue descender system comprising a casing, which incorporates a bracket for attachment to a person's body harness whereby the bracket can be releasably attached to a load element attached to a safety line and the safety line may then be attached to a secure anchorage. Various release mechanisms are disclosed including release that is initiated remotely such as by the transmission and receipt of radio signals. The receipt of radio signals may be used to initiate the activation of an actuator that can then carry out the release operation. An example given of a typical actuator is a pyrotechnic actuator (explosive squib) that is initiated electrically. When the load element is released from the bracket, elongate that is also attached to the load element is deployed at a speed controlled by a speed control means thereby controlling the descent of the person being rescued. [0008] When a person is arrested after a fall, loads of up to 6 kN can be applied between the harness and safety line [0009] WO2009/027619 discloses methods of attaching the rescue apparatus to a harness in normal use whereby the weight of the rescue apparatus is supported at least in part by alternative means other than the rigid load elements described in GB2414005. [0010] In both documents identified (GB2414005 and WO2009/027619), the prior art systems described use a descent line that is payed out from the descent reel is connected to the safety line by a load element and a release means actuated to permit release of the load element to allow paying out of the descent line from the descent line reel or store. In both prior art arrangements the full load of the fall and the suspended user is passed via the release means. This results in a high force necessary to effect release of the release means. Hence in [0011] WO2009/027619 the invention utilises detonation of an explosive squib as an exemplary release means for releasing the release pin 15 . SUMMARY [0012] An improved arrangement has now been devised. [0013] According to a first aspect, the present invention provides a descender device for enabling a suspended body to be lowered, the descender device comprising: a descent line, a release element to be actuated by a person, the release element arranged in a restraint configuration to inhibit the descent line from being deployed and in a release configuration to permit the descent line to be deployed; wherein, a restraint arrangement is arranged prior to deployment of the descent line, to clamp or pinch a length of flexible line thereby to inhibit deployment of the descent line, the restraint arrangement being reconfigurable upon release of the release element to permit the descent line to be deployed. [0017] The descent line may in use connected (either directly or by means of an intermediate line or lines or connectors) to a lifeline device such as a self retracting lifeline of a safety block. Connection loops, rings and/or karabiners may be provided for this purpose. [0018] It is preferred that the release element is connected to a pull tether, which pull tether extends over a shoulder portion of a harness. [0019] In one embodiment, it is preferred that the release element secures through a loop or ring, which loop or ring is attached to a flexible line. [0020] In one embodiment, the release element may secure through a loop or ring formed in, or connected to, the descent line or a length of separate line, such as a binding line (which separate/binding line is typically connected to the descent line). [0021] In one embodiment the release element may comprise a pin extending through the loop or ring, the loop or ring preferably being pulled off over the end of the pin when moving to the release configuration. [0022] In one embodiment, the release element is preferably connected to a pull tether, which pull tether has a finger pull portion to be gripped by a user, and in addition to the finger pull portion, a second pull formation. [0023] It may be preferred that the second pull formation is in use positioned adjacent the shoulder, torso or back of a user. This provides for ease of remote access to pull the tether by means of the second pull formation. [0024] The second pull formation may comprise a loop or ring, preferably a rigid or semi rigid form, secured with respect to the pull tether and arranged to stand proud of the user when the device is mounted (typically by harness) to the user. [0025] In a preferred embodiment the restraint arrangement comprises a clamp arrangement which is arranged to clamp or pinch a binding portion of the descent line and/or a length of separate binding line (which binding line is typically connected to the descent line). [0026] Preferably, the binding portion, or binding line is clamped or pinched at one or more points intermediate the opposed ends of the line and spaced from the release element. [0027] It may be preferred that movement of the release element to the release configuration permits (or causes) the restraint arrangement to reconfigure from the clamping position, to permit the line to pass. [0028] In a preferred embodiment, the restraint arrangement comprises a plurality of spaced bars (pinch bars), the flexible line (for example the descent line and/or a binding line) preferably passing serpentine-wise through the bars. [0029] It is preferred that the spacing of the bars on the rack can reduce to clamp or pinch the flexible line between the bars or expand to permit the line to pass via the bars in the rack. [0030] Beneficially, moving of the release element to the release configuration permits or causes the spacing between the bars on the rack to increase from the reduced spacing configuration. [0031] It is preferred that the flexible line (the descent line and/or a separate binding line) is secured relative to the release element in the restraint configuration to inhibit the descent line from being deployed and released from the release element in a release configuration, in order to permit the descent line to be deployed. [0032] In one embodiment the binding line and the descent line are configured to both extend through the clamping arrangement before deployment of the release line. [0033] In such an embodiment it is a preferred consequence that the descent line and the binding line are arranged to be drawn through the clamping arrangement in unison (preferably side by side) when the descent line is deployed. [0034] The binding line and the descent line may beneficially be connected to one another (typically at a connector ring) at a position downstream deployment-wise of the clamping arrangement. [0035] In certain embodiments, the release means may comprise a pin. [0036] It is preferred that, when actuated to permit the descent line to be deployed the release element is forced to rupture or break a capture element (such as for example a breakable clip) securing the release element in the restraint configuration. [0037] It is preferred that the descent line is stored on-board the descender device. [0038] The descent line is preferably wound on a reel pending deployment. [0039] The device preferably includes a brake arrangement to limit the deployment rate of the descender line. [0040] According to a second aspect, the invention provides a descender device for enabling a suspended body to be lowered, the descender device comprising: a descent line, a release element to be actuated by a person, the release element arranged in a restraint configuration to inhibit the descent line from being deployed and in a release configuration to permit the descent line to be deployed; wherein, the release element is connected to a pull tether, which pull tether extends in a harness over a shoulder portion of the harness. [0044] According to a further aspect, the invention provides descender device for enabling a suspended body to be lowered, the descender device comprising: a descent line, a release element to be actuated by a person, the release element arranged in a restraint configuration to inhibit the descent line from being deployed and in a release configuration to permit the descent line to be deployed; wherein, the release element secures through a loop or ring, which loop or ring is attached to a flexible line. [0048] It is preferred that the release element comprises a pin extending through the loop or ring. [0049] According to a further aspect, the invention provides a descender device for enabling a suspended body to be lowered, the descender device comprising: a descent line, a release element to be actuated by a person, the release element arranged in a restraint configuration to inhibit the descent line from being deployed and in a release configuration to permit the descent line to be deployed; wherein, the release element is connected to a pull tether, which pull tether has a finger pull portion to be gripped by a user, and also spaced from the finger pull portion and a second pull formation. [0052] The features described as preferred or optional in respect of the first aspect may also be considered preferred or optional features of the further aspects of the invention. [0053] According to a further aspect, the invention provides a descender system for enabling a suspended body to be lowered, the descender system comprising: a descent line, a descender device provided with a release element arranged in a restraint configuration to inhibit the descent line from being deployed and in a release configuration to permit the descent line to be deployed, wherein: i) the descender device includes a load member movable between a first position in which the release element is restrained to be held in the restraint configuration and a second position in which the release element can be moved to the release configuration; and/or, ii) the descender device includes a clamp arrangement arranged prior to deployment of the descent line, to clamp or pinch the descent line, or a length of line connected to the descent line, at one or more points intermediate the opposed ends of the line and spaced from the release means, the clamp arrangement being reconfigurable to permit the line to pass; and/or; iii) the load of the suspended body imparted to the descender device is not transmitted primarily via the release element the load on the release element is substantially independent of the load imparted by the suspended body. [0059] In accordance with the invention, the descent line can extend completely through the descender device as a unitary line or can be comprised of a plurality of connected lines tethers or webs. The descent line is in use connected (either directly or by means of an intermediate line or lines) to a lifeline device such as a self retracting lifeline of a safety block. Connection loops and/or karabiners may be provided for this purpose. [0060] It is preferred that the load member is normally biased to the first position. This may be achieved by a spring element. [0061] It is preferred that the load member is moved to the second position when a load is applied to the load member as a result of the person becoming suspended in a fall arrest event. This means that the load member moves effectively automatically to the second position when the person becomes suspended. [0062] The load member preferably has an abutment portion which moves with the load member (and may in fact comprise a portion of the load member), the abutment portion abutting, engaging or otherwise blocking the release element in the first position (thereby preventing movement of the release element from the restraint configuration), and being removed from abutment or engagement with the release element in the second position (thereby permitting movement of the release element from the restraint configuration). [0063] In a preferred embodiment, the load element is movable pivotably (or rotatably) between the first and second position. [0064] It is preferred that the load element is arranged for attachment to a user wearable harness. [0065] According to a further aspect, the present invention provides a fall arrest system incorporating a descender system as defined herein. [0066] The invention will now be further described, by way of example only, and with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0067] FIGS. 1A and 1B are front and side views, respectively, of a first embodiment of a rescue descender device 1 in accordance with the invention in an initial or first configuration. [0068] FIG. 2 is a schematic perspective exploded view of the rescue descender device 1 of FIGS. 1A and 1B . [0069] FIGS. 3A and 3B are front and side views, respectively, of the rescue descender device 1 of FIGS. 1A and 1B in an alternative configuration. [0070] FIGS. 4A and 4B are front and side views, respectively, of the rescue descender device 1 of FIGS. 1A and 1B in a further configuration. [0071] FIGS. 5A and 5B are front and side views, respectively, of the rescue descender device 1 of FIGS. 1A and 1B in a final configuration. [0072] FIGS. 6A, 6B, 6C and 6D are views showing the rescue descender device 1 of FIGS. 1A and 1B mounted to a harness worn by a user. [0073] FIGS. 7A, 7B and 7C are opposed side views and a front view, respectively, of an alternative embodiment in accordance with the invention, in a first (line pinching or clamping) configuration. [0074] FIGS. 8A, 8B and 8C are opposed side views and a front view corresponding to the views of FIGS. 7A, 7B and 7C , but in an alternative (line pinching or clamping) configuration. [0075] FIGS. 9A and 9B are opposed side views of the arrangement of FIGS. 7A to 8C in a line released configuration. [0076] FIG. 10 is a perspective view of the parts making up an alternative embodiment of a descender device according to the invention. [0077] FIGS. 11A and 11B are side and front views, respectively, of the embodiment of FIG. 10 . [0078] FIG. 12 is a front view of the embodiment of FIG. 10 in an alternative configuration. [0079] FIGS. 13A and 13B are side and front views, respectively, of the embodiment of FIG. 10 in an alternative configuration. [0080] FIGS. 14A, 14B and 14C are perspective views of a further embodiment of the invention in various sequential stages of operation. DETAILED DESCRIPTION [0081] Referring to the drawings there is shown a rescue descender device 1 in accordance with the invention. As shown in FIGS. 6A to 6D , the rescue descender device 1 is arranged to be worn on the back of a user mounted to a body harness 30 and be connected to a fall arrest lifeline 36 , such as a self retracting lifeline as are known in the art. [0082] The rescue descender device 1 comprises, a first length of binding webbing 2 comprising an upper loop 3 , a lower loop 4 and an intermediate webbing length 5 which is stitched together to form a double thickness between the upper and lower loops 3 , 4 . The upper loop 3 of the first length of webbing is arranged to be connected to a fall arrest lifeline such as the self retracting lifeline 36 as are known in the art. [0083] The first length of binding webbing 2 is wrapped, serpentine fashion, around a restraint device 6 which comprises a U shaped frame 7 having spaced limbs 8 , at their upper ends joined by a curved crosspiece, and at their lower ends connected to a fixing bracket 9 connected to a descent line store device 10 . [0084] A series of movable pinch bars 11 are mounted on the spaced limbs 8 and the first length of binding webbing 2 is wrapped around the movable pinch bars 11 as shown in the figures in serpentine fashion. The movable bars 11 can slide up and own the spaced limbs 8 , upward movement being limited by a load arm mounting component 12 that is fixed relative to the U shaped frame 7 . The movable pinch bars 11 are provided with respective bores to accommodate the limbs 8 . The load arm mounting component 12 carries a pivotally mounted pivoting load arm 13 which has a cross bar 14 and a pair of spaced arms mounting arms 15 a 15 b. The pivoting load arm 13 is connected by a webbing loop harness connector 16 to the safety harness (not shown) worn by a user. The webbing loop harness connector 16 is looped around the cross bar 14 of load arm 13 . [0085] The pivoting load arm 13 is provided with an abutment piece 17 such that when the pivoting load arm 13 is biased to its normal at rest position (as shown in FIGS. 1A and 1B ) by the biasing torsion spring 18 , the abutment piece 17 is positioned to lie adjacent the head of a release pin 19 , which is mounted in respective receiving bores 20 of the mounting component 12 . The head of the release pin 19 is connected to an end of a pin release tether 21 . The lower loop 4 of the first length of webbing 2 is connected via a connector clasp 22 to a descent line 23 . The descent line 23 is fixed at its other end and is wound on a descent line drum 24 . [0086] The descent line drum 24 is mounted to a support plate 25 . A brake device 26 is also mounted to the support plate 25 . The brake device 26 is coupled to rotation of the descent line drum 24 , by means of a gear arrangement comprising a main gear 27 which rotates with the brake device 26 and is connected to a brake pinion gear 28 by means of an idler gear 29 . As the brake device 26 rotates to deploy the descent line 23 , the brake pinion gear 28 is activated by the main gear 27 in order to brake the rotation of the descent line drum 24 and slow deployment of the descent line 23 . [0087] As shown in FIGS. 1A and 1B , when the rescue descender device 1 is ready for use, it is in the configuration shown. The webbing loop harness connector 16 is connected to the users harness and the upper loop 3 is connected via the safety line 36 (for example a standard self retracting lifeline) to an anchor point. In this way the user is securely anchored to an anchor point via the rescue descender device 1 . In this configuration, the release pin 19 cannot be removed from the receiving bores 20 of the load arm mounting component 12 . This is because the abutment piece 17 of the pivoting load arm 13 is positioned adjacent the head of the release pin 19 and prevents removal of the release pin 19 . In the embodiment shown the torsion spring 18 biases the pivoting load arm 13 to this ‘normal’ position, although the shape of the pivoting load arm 13 is such that the pivoting moment normally biases the pivoting load arm 13 to this position under gravity in any case. In this configuration the user can move about their business unhindered, but the release pin 19 cannot be removed either intentionally or unintentionally. [0088] In the event of a fall arrest event, the rescue descender device 1 reconfigures from the position shown in FIGS. 1A and 1B to the position shown in FIGS. 4A and 4B via the intermediate position shown in FIGS. 3A and 3B . As the user becomes suspended from the anchor point via the safety line 36 connected to the upper loop 3 of the first length of the binding webbing 2 , the intermediate webbing length 5 pulls up on the series of movable bars 11 causing the movable bars 11 to slide upwardly and pinch the intermediate webbing length 5 securely. This ensures that the intermediate webbing length 5 and the movable bars 11 are held fast. The main upward force acts via the lowermost of the movable bars 11 and the intermediate binding webbing length 5 which is wrapped around the lowermost of the movable bars 11 . This configuration is shown in FIGS. 3A and 3B . [0089] Simultaneously, under the weight of the user now suspended from the anchor point, the pivoting load arm 13 pivots downwardly (arrow A). In so doing, the abutment piece 17 of the pivoting load arm 13 pivots out of its blocking position adjacent with the head of release pin 19 . Therefore once the fall arrest event occurs and the pivoting load arm 13 is loaded by the user's suspended weight, the abutment piece 17 moves such that the release pin 19 can be pulled out of the receiving bores 20 of the load arm mounting component 12 . [0090] In this embodiment the release pin 19 can only be removed from its home position secured in the receiving bores 20 of the load arm mounting component 12 when the pivoting load arm 13 is moved from its normal position. Furthermore the arrangement ensures that the pivoting load arm 13 moves from its home position automatically as a result of a fall arrest event. The pin release tether 21 is connected to the release pin 19 and has an end accessible to be pulled by the user to enable the release pin 19 to be removed when ready. [0091] As shown in FIGS. 6A to 6C the release tether 21 can be secured within a pack or enclosure mounted on or with the harness 30 ready for use. In the embodiment shown the release tether is secured to a shoulder strap 30 a on the front of the user and a finger grip toggle 31 is connected to the tether line 21 to be pulled by the user in order to release the release pin 19 . The tether line 21 is provided with a Velcro type band 32 to secure to the shoulder strap 30 a. [0092] An over cover 33 is provided to prevent accidental release. In a preferred embodiment the tether line 21 can be provided with a second pull formation 37 in addition to the finger pull toggle 31 . The second pull formation 37 is a rigid or semi-rigid ring (such as a ‘D’ ring) secured in position on the tether line 21 . The second pull formation 37 is in use positioned to stand proud of, or project from, the shoulder strap of the harness adjacent the shoulder, torso or back of a user. The second pull formation 37 is shown in FIGS. 6A 6 B 6 D (but omitted from FIG. 6C ). In use the second pull formation 37 can be accessed remotely from the user, for example by means of hook rod used from above, in order to pull the release tether line remotely from the user. This enables the user to be lowered using the decent device actuated from a remote position. [0093] Once the user has fallen and his fall has been arrested, he is suspended by the device 1 which is attached to the harness 30 on the back of the user. As shown in FIG. 6C and 6D , when the user is ready he opens the over cover 33 , peels back the band 32 and pulls on the pin release tether 21 to remove the release pin 19 from its home position. The resultant operation is shown in FIGS. 5A and 5B . The release pin 19 releases from the lower loop 4 of the first length of the binding webbing 2 . As a result of releasing the lower loop 4 of the first length of webbing, the lower loop 4 can drop down releasing the tension on the intermediate webbing length 5 wound around the lowermost one of the movable pinch bars 11 . As a result the series of movable bars 11 can drop downwardly (see the arrows in FIG. 5B ) becoming spaced out on the U shaped frame 7 . The intermediate webbing length 5 is no longer bound fast by the movable pinch bars 11 and as a result the intermediate webbing length 5 can feed through the pinch bars 11 in an upward direction of the U shaped frame 7 . [0094] The closed end of the lower loop 4 catches on the connector clasp 22 and pulls the connector clasp 22 through the movable bars 11 along a serpentine path in an upward direction of the U shaped frame 7 . In so doing the descent line 23 is also pulled from the descent line drum 24 along the same path. As a result loop 2 moves away from the U shaped frame 7 , and the U shaped frame 7 and the user attached via the webbing loop harness connector 16 descends relative to the upper loop 2 . FIGS. 4A and 4B show the connector clasp 22 pulled completely through the U shaped frame 7 and bars 11 together with the upper end of the connector clasp 22 . The brake device 26 acts to slow the rate of descent in accordance with a preset desired descent rate. [0095] In this embodiment, the release pin 19 is not a primary load supporting member of the rack restraint device 6 . The main vertical load is taken up by the intermediate webbing length 5 folded under the lowermost pinch bar 11 . The length 5 is clamped between the pinch bars 11 , such that the downward pulling force exerted by the loop 4 on the pin 19 is negligible when compared with the impulse weight or force as a result of the suspended user. [0096] Accordingly the force required to remove the pin 19 (when the abutment piece 17 is moved clear of the path of the release pin 19 ) is sufficiently low to enable the user to remove the pin 19 manually by pulling on the release pin tether 21 . The pivoting load arm 13 moves automatically as a result of the load applied by the suspended user to clear the abutment piece 17 from obstructing removal of the release pin 19 . The load of the suspended user imparted between the length of webbing 2 (connected to the safety line 36 ) and the descender device is not transmitted primarily via the release pin 19 . The load on the release pin 19 is substantially independent of the load imparted by the suspended user. [0097] The first length of webbing 2 is connected to the descent line 23 by the clasp 22 . These can be considered effectively as a single line as they act as such when deployed. The webbing 2 is connected to the safety line 36 . [0098] Referring now to FIGS. 7A to 9B , there is shown an alternative embodiment of the invention. [0099] In the arrangement shown in FIGS. 7A to 9B the restraint device 6 of the first embodiment having the U shaped frame 7 with the bars 11 movably mounted on the limbs 8 is replaced by a cam action restraint device 56 . The cam action restraint device 56 comprises a cam actuator 57 which is mounted to a support plate 58 by means of a pivot pin 59 mounted between limbs 60 . A length of descent line 61 extends in the channel defined between the limbs 60 past the position of the pivot pin 59 and the cam actuator 57 . The cam actuator 57 has a length of descent line 61 extending radially with respect to an arcuate slot 63 . The length of descent line 61 receives the pivot pin 59 . The arcuate slot 63 receives the release pin 64 . The cam actuator 57 is provided with a serrated grip zone 65 for biting into the length of descent line 61 to clamp the length of descent line 61 fast against the support plate 58 . [0100] The cam action restraint device 56 is provided with a pivoting load arm 66 corresponding to the pivoting load arm 13 of the first embodiment, which has projecting abutment pieces 67 corresponding to the abutment piece 17 of the first embodiment. The abutment pieces 67 act to prevent removal of the release pin 64 from the arcuate slot 63 until the load is applied to pivot the pivoting load arm 66 as a result of a fall (in a similar means to operation of the first embodiment). The arrangement of this embodiment is set up for use by arranging the cam action restraint device 56 in the configuration shown in FIGS. 7A to 7C . In this position, presence of release pin 64 in the arcuate slot 63 ensures that the cam actuator 57 pivots about the end of the eccentric slot 62 closest to the arcuate slot 63 . In so doing when the length of descent line 61 is pulled upwardly by a load, acting in the direction of arrow Z (as shown in FIGS. 8A to 8C ), the cam actuator 57 tends to pivot to become increasingly engaged with length of descent line 61 , ensuring that the clamping grip against support plate 58 is increased. [0101] The arcuate slot 63 permits pivoting of the cam actuator 57 about the pivot pin 59 to a limited arc. In this way increasing load on the length of descent line 61 results on an increasingly secure grip of length of descent line 61 against support plate 58 . In the set up position, the pivoting load arm 66 , which is connected to the users harness, is biased to a position in which one of the abutment pieces 67 are positioned adjacent the end of the release pin 64 , preventing the release pin 64 from being removed from its position within arcuate slot 63 . [0102] When the user falls and the fall is arrested, the pivoting load arm 66 pivots to a release position under the load applied by the user suspended from the length of descent line 61 . This is the position shown in FIGS. 8A to 8C . This happens in a similar manner as for the first embodiment. In so doing, the abutment piece 67 moves clear of the release pin 64 and no longer acts as an obstruction to removal of the release pin 64 from the arcuate slot 63 . The user can pull on a release pin tether 68 which is connected to the release pin 64 in order to pull the release pin 64 completely out of the arcuate slot 63 . In so doing, cam actuator 57 is able to move away from the length of descent line 61 and the support plate 58 and the clamping grip of the cam actuator 57 against the support plate 58 is released. The eccentric slot 62 moves with respect to the pivot pin 59 from the clamping position shown in FIGS. 7 and 8 to a release position shown in FIGS. 9A and 9B . The cam actuator 57 is free to rotate to the release position as shown in FIGS. 9A and 9B . In this position, the length of descent line 61 can pas through the cam action restraint device 56 . [0103] The length of descent line 61 can extend completely through the device and be connected at an upper end to the safety line and wound below the cam action restraint device 56 onto a storage reel (such as the reel 24 ). Up-line and down-line of the cam action restraint device 56 , the descender device can be in accordance with the first described embodiment. Accordingly when the cam action restraint device 56 has been released to the configuration of FIGS. 9A and 9B , the length of descent line 61 can be wound from the descent line drum 24 along the path through the cam action restraint device 56 . The brake device 26 acts to slow the rate of descent in accordance with a preset desired descent rate. [0104] In this embodiment, the release pin 64 is not a load supporting member of the cam action restraint device 56 and accordingly the force to remove the pin 64 (when the abutment piece 67 is moved clear of engagement with the release pin 64 ) is sufficiently low to enable the user to remove the pin 64 manually by pulling on the release pin tether 68 . The pivoting load arm 66 moves automatically as a result of the load applied by the suspended user to clear the abutment piece 67 from obstructing removal of the release pin 64 . The load of the suspended user imparted between the length of descent line 61 and the descender device 56 is not transmitted primarily via the release pin 64 . The load on the release pin 64 is independent of the load imparted by the suspended user. [0105] Referring now to FIGS. 10 to 13B , there is shown a further embodiment of a descender device 101 , which is similar in general terms to the device 1 of FIGS. 1 to 5 . In this embodiment a restraint rack device 106 has a U shaped frame comprising spaced limbs 108 and two pinch bars 111 which are slidably mounted on the limbs 108 . The main difference of this embodiment over the first described embodiment is in relation to the connection between the binding webbing 102 and the descent line 123 . [0106] In the previously described embodiment the lower loop 4 of the binding webbing 2 was secured to the upper end of the descent line 23 by means of the clasp 22 . This requires the clasp 22 to be pulled through the bars 11 when the descent line is being deployed. In practice the clasp can foul or become trapped resulting in non-ideal deployment or even malfunction. [0107] In the embodiment of FIGS. 10 to 13B , the binding webbing 102 and the release line are connected at a D ring 170 which is positioned downstream of the restraint rack device 106 and which therefore does not need to be pulled through the rack during deployment of the release line 123 . The upper portion of the release line 123 is threaded serpentine fashion through the pinch bars 111 . The binding webbing is likewise threaded serpentine fashion through the pinch bars 111 and the lower loop 104 is secured about a release pin 119 which is secured in a cradle 118 provided on a platform 112 by means of a breakable clip 171 . The platform 112 is provided with mounting apertures to enable mounting on the limbs 108 and is secured in position on the rack frame device limbs 108 by means of a pin 175 passing through bores 181 , and also the mating plugs 185 . The swing arm 113 is pivotally mounted on the plugs 185 and provides for securing to the users harness. [0108] As shown most clearly in FIG. 11B , the release pin 119 is secured by the breakable clip 171 in a specific orientation in the cradle 118 . When the device is loaded as a result of a fall arrest event, the binding webbing 102 is pulled tight resulting in the pinch bars 111 being pulled upwardly towards the top of the rack device 106 . The release line 123 is pinched by the pinch bars preventing the release line 123 from being pulled through the device. In the loaded condition, the loop 104 of the binding webbing 102 is secured over the release pin 119 . The webbing 102 extends downwardly from the pin 119 via an opening 190 in the cradle 118 . Therefore in the loaded condition, the tension in the webbing 102 tends to securely hold the release pin 119 in the cradle. The end of the pin 119 rests on a ledge 195 adjacent the opening 190 . When the user is suspended and wishes to deploy the release line 123 , the user tugs sharply on the release pin tether 121 . In doing so the release pin ruptures the clip 171 and pivots from the position shown in FIG. 10B to the position shown in FIG. 11B . In the position shown in FIG. 12 the end of the release pin 119 is no longer supported on the ledge 195 and the downward force acting on the pin by means of the loop 104 causes the loop 104 to be pulled downwardly off the end of pin 119 and through the opening 190 . In so doing the binding action exerted by the binding webbing 102 on the pinch bars 111 is released and they are able to move apart on the limbs 108 . This enables the binding webbing 102 and the release line 123 to be drawn simultaneously through the pinch bars 111 . This situation is shown in FIGS. 13A and 13B . [0109] A variation on this theme is shown in the embodiment of FIGS. 14A to 14C , in which like items are referred to with the same reference numbers as the previous embodiment of FIGS. 10 to 13B . In this embodiment the opening 190 is replaced by a slot 290 downwardly through which the end loop 104 of the binding webbing 102 is pulled when the release pin breaks free from the clip 171 . A guide frame 199 is provided for the release pin tether 121 in order to ensure that the release pin is pulled from the correct direction to effect release.

1a

This application is a division of application Ser. No. 09/129,832, filed Aug. 5, 1998, now U.S. Pat. No. 6,047,216, which is a continuation-in-part of presently U.S. patent application No. 08/641,045 entitled MICROWAVE TREATMENT FOR CARDIAC ARRHYTHMIAS, filed on Apr. 17, 1996, now U.S. Pat. No. 5,904,709. ORIGIN OF THE INVENTION The invention described herein was made in the performance of work under a NASA contract and is subject to the provisions of Section 305 of the National Aeronautics and Space Act of 1958, Public Law 85-568 (72 Stat. 435; 42 U.S.C. 2457). BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to methods and apparatus for using arterial blood pressure to dilate the lumen rather than expanding/cutting mechanical means so as to preserve the sensitive endothelial lining of the artery. More specifically, the present invention relates to production of a temperature profile within the arterial wall that corresponds to the atherosclerotic lesion size, shape, and position so as to necrose (ablate) connective tissue and soften plaque to thereby impart increased flexibility to the arterial wall. 2. Description of Prior Art Atheroscleroses, also known as hardening of the arteries, is one of the most common types of heart disease. Each year several hundred thousand people die of this disease or of complications relating thereto. By the age of forty, many people have already developed atherosclerotic lesions although no symptoms may appear. Atherosclerosis is a progressive disease wherein fatty, fibrous, calcific, or thrombotic deposits produce atheromatous plaques within the arterial walls as indicated generally in FIG. 11 . Moreover, atherosclerosis tends to involve large and medium sized arteries such as the aorta, iliac, femoral, cerebral, as well as the coronary artery. The atherosclerotic lesions are substantially comprised of plaque and scar tissue. The plaque is typically encapsulated within living connective tissue. Plaque is a heterogenous material, sometimes non-living, that may include calcified, wax-like, fibrotic, fatty, and brittle components. As the lesions within the arterial walls grow in size, the lumen or passageway through the coronary artery may be correspondingly reduced in effective cross-sectional diameter (stenosis). The constricted (stenotic) lumen may then restrict the nutrient blood flow to muscles of the heart. Therefore, atheroscleroses is often a major contributing factor in both acute and chronic heart problems. Also, when the lumen is sufficiently narrowed, the rate of blood flow may be so diminished that an affixed blood clot (thrombus) or circulating blood clot (embolus) may spontaneously occur. Thus, the presence of atherosclerotic plaque not only reduces blood flow to the heart muscle but also is a major predisposing factor in coronary thrombosis. While pharmacological treatment is often used to treat atherosclerosis, such treatment is sometimes considered to be insufficiently effective for increasing blood flow. Therefore, techniques such as balloon angioplasty (percutaneous transluminal coronary angioplasty) have been developed to mechanically increase the luminal opening. However, mechanical techniques tend to traumatize the artery and often result in restenosis (reclosing of the lumen). Standard balloon angioplasty produces a gross trauma that severely injures the endothelium or lining of the artery. The endothelium is a very fragile layer of cells that performs the very important function of limiting thrombotic processes (See FIG. 12 ). Unlike other surfaces and materials, when blood cells come in contact with the endothelium there is no tendency to form a clot. The layer of endothelial cells normally covers the internal surface of all vessels, rendering the vessel surface compatible. i.e., non-thrombogenic and non-reactive with blood. If the endothelium is damaged, platelet deposition becomes a problem. Once this layer is injured, it does not normally grow back uniformly and so damage thereof tends to permanently induce thrombotic processes. Injury to the endothelium has been associated with accelerating of atherosclerotic processes and/or restenosis. At least one patent discussed hereinafter teaches to alleviate, at least to some extent, damage caused to the endothelium by providing a bioprotective layer around the angioplasty balloon to cushion, coat, and insert anti-inflammatory agents prior to opening the balloon. Another patent discussed hereinafter teaches reducing trauma damage to the endothelium by reducing angioplasty balloon pressure using heat and feedback control. However, due to the mechanical forces in balloon angioplasty, damage to the fragile endothelium may still occur. The bioprotective coatings may, according to the patent teachings, also reduce problems created by angioplasty-induced tissue tears or cleavages that can result in blood accumulation along the cleavage planes of arterial wall layers. The thickening caused during such problems may acutely block or occlude the arterial lumen and require emergency interventions such as stents or open heart surgery. The trauma to the endothelium and to arterial walls from balloon angioplasty often evoke a potent inflammatory response, or restenosis (reclosing of the artery), whereby scar tissue growth and other processes occur to once again reduce the arterial lumen opening. As discussed in some detail below with respect to numerous different techniques, restenosis is probably one of the most significant problems that occurs with existing techniques for dilating or opening the arteries. Restenosis may occur due to numerous processes including the following: clots that grow gradually or contain growth hormones released by, plateletes within the clot, clots formed due to exposure to collagen (connective tissue) which is highly thrombogenic, growth hormones released by other cells that cause smooth muscle cells and fibroblasts in the region to multiply, tears in the artery wall that expose blood to foreign material and proteins thereby producing clots, white cells that migrate to the area and lay down scar tissue, growth of new tissue due to any kind of inflammatory response, and/or other factors that may cause the artery lumen to reclose. Several different processes may operate simultaneously to cause restenosis. After balloon angioplasty procedures, narrowing of the artery by 50% may occur in more than one-half of the patients and about one quarter of the patients may require a repeat procedure by the end of one year. As mentioned above, restenosis (reclosing of the artery) remains a major problem in treatment of atherosclerosis by balloon angioplasty. While significant efforts have been made to dampen the reactive proliferation with a variety of pharmacological and genetic interventions, these interventions have thus far found limited or no successful clinical application. Another problem with balloon angioplasty relates to the fact that the lesions, or atheromas, within arterial cross-sections are typically asymmetrically distributed. That is to say the lesions often occur on one side, portion, or sector of the artery while an opposite or adjacent sector of the artery is relatively free of the disease. It was initially postulated that the increase in endovascular pressure created with a balloon would somehow selectively crush lesions. However, given that the thick-walled sectors containing atheromas are typically abundant with dense collagen or connective tissue, the lesions may actually be less likely to undergo deformation than the opposite relatively thin-walled, lesion-free sectors. Thus, the maximum trauma produced by balloon angioplasty may well occur in the healthy sector of the artery. Some of the patents discussed hereinafter attempt to reduce, at least to some extent, this problem and related problems by first heating the artery to soften the plaque. However, unless the heating is applied selectively to the atheromas heat damage may occur to the artery and endothelium. As well, mechanical trauma may still occur to the endothelium and/or other arterial components. Acute closure of the lumen after balloon angioplasty remains the most common cause of failed angioplasty and occurs in approximately 5% of the patients. This complication may be associated with varying degrees of mortality that may exceed 50% when emergency coronary bypass surgery has to be performed. For the above reasons, balloon angioplasty is often problematic due to restenosis or, less frequently, abrupt closure. Therefore, other catheter techniques for the mechanical widening of the lumen of diseased coronary arteries have been devised, including various tissue cutting techniques. Directional coronary atherectomy (DCA) involves the selective excision and retrieval of atheromatous or proliferative tissue obstructing the arterial lumen. In this procedure, the end of the catheter is provided with a fenestrated metal cylinder within which a piston-like cutter is moved via a torque cable. The cut tissue is recovered in a distal portion of the catheter. As compared with balloon angioplasty, the initial luminal widening achieved by DCA is similar or perhaps slightly better. Again, restenosis is problematical and, as before, the restenosis is probably acerbated by damage to the endothelium. Rotational atherectomy incorporates a rotary file or burr (brass ellipsoid of varying diameter covered with diamond chips—rotablator) into the distal portion of the catheter. The rotary file or burr is connected to a motor-operated drive shaft. Abrasion of the narrowed artery segments produces micro particles that are allowed to escape into the distal circulation for capillary entrapment. The rotablator has been used for treating heavily calcified lesions, lesions at branch points (‘ostial disease’), and lesions involving long arterial segments (‘diffuse disease’). Restenosis frequently occurs. However, because this instrument is often used to treat refractory or difficult-to-treat lesions, the results of the treatment are difficult to compare with those of balloon angioplasty. Transluminal extraction catheter atherectomy (TEC) involves use of a catheter with tip-mounted cutting blades. The tissue fragments are recovered by aspirating a flush solution during cutting. As with the other mechanical devices discussed above, restenoses are frequent. In summary, the exact role of atherectomy or mechanical tissue cutting devices is not yet completely defined for treatment of atherosclerosis, but it is fair to say that such devices do not overcome the major complication of balloon angioplasty, i.e.. restenosis, Eximer (UV) laser coronary angioplasty systems are the only laser devices currently approved by the FDA for treatment of atherosclerosis. These devices act to remove tissue at the lesion from the artery. Light in the UV range can remove tissue by triggering photochemical reactions (photoablation). However, there is also considerable evidence that UV lasers remove tissue by a thermal mechanism like that of longer wavelengths (vaporization) such as visible, infrared, millimeter wave, and microwave spectra. One characteristic of eximer radiation (308 nm) is that the energy deposition is quite superficial. Accordingly, the procedure destroys the superficial cell layer (endothelial cells) and consequently produces a strong inflammatory response as does balloon angioplasty. Not unexpectedly, and in contrast to early claims, UV laser angioplasty does not have a lower restenosis rate than balloon angioplasty. This fact also suggests that tissue deformation, as occurs in balloon and rotablator procedures, is not the major determinant of restenosis because lasers do not forcefully distend artery walls. Acute coronary closure after balloon angioplasty may be treated in several ways including perfusion balloon angioplasty (prolonged balloon inflation with protective distal coronary perfusion), atherectomy catheters as discussed above, and intracoronary stents. Coronary stents are designed to scaffold artery walls. The use of stents for acute closure is associated with a high initial success rate in maintaining arterial patency. However, stent therapy suffers from several drawbacks including subacute stent thrombosis, bleeding due to the necessarily aggressive anticoagulation treatment, and restenosis that occurs in 30% to 50% of the cases. The use of stents in non-emergency situations is an experimental procedure. Another procedures for treating atherosclerosis is coronary artery bypass surgery. However, this procedure does not clearly suggest a better prognosis than balloon angioplasty and has the disadvantage of being a major surgical procedure. Catheters with 1.2 or 1.7 mm ball tips for ultrasound (195 kHz) destruction of atheromatous lesions in artery walls have been reported. Experimental use of microwave balloon angioplasty with a gap antenna operating at 2.45 GHz has been reported and the authors concluded that balloon angioplasty combined with microwave heating yielded wider luminal diameters four weeks after intervention. Other uses of heating in combination with balloon angioplasty are discussed in the following patents. U.S. Pat. No. 4,583,556, issued Apr. 22, 1986, to Hines et al., discloses a microwave applicator with a suggested use for treating cancer. The microwave applicator is said to provide uniform heating without hot spots and includes a first electrical conductor and a second electrical conductor substantially shielding the first conductor in a transmission line configuration. A coil is provided as a third electrical conductor that surrounds an unshielded portion of the first conductor. No particular microwave frequencies are designated. U.S. Pat. No. 5,496,311, issued Mar. 5, 1996, to Abele et al., discloses an expandable balloon catheter that simultaneously heats the plaque and applies pressure to tissue of the lumen with feedback and software control to thereby significantly reduce the balloon pressure necessary to dilate the artery. The heating is preferably IR (convective) to about 50° C. to 70° C. at the balloon surface, for about 15 to 60 seconds, with balloon pressure of about 2 atm.. The patent teaches that avoiding the high stress of normal is balloon angioplasty (about 10 atm balloon pressure) reduces side effects such as post operation platelet deposition, clotting, intimal proliferation (scarring) and hormonal changes that cause restenosis. Abele et al. teach that high balloon stress may also cause long term problems including aneurysms (weakening or thinning of the vessel wall). Thermal and/or reduced mechanical injury to the endothelium may well occur with this technique. No mention is made of directing heat towards a particular segment of the artery. U.S. Pat. No. 5,470,352, issued Nov. 28, 1995, to C. M. Rappaport, discloses a balloon angioplasty device that includes a microwave antenna preferably operating at about 1.8 GHz. The goal of the antenna design is to heat plaque to temperatures in the range of 95° C. to 143° C. without overheating healthy artery tissue by providing heating power in a circumferentially oriented electric field. However, the somewhat erroneous presumption is made that plaque is necessarily on the inside of the artery walls rather than normally being within the artery walls where the circumferential field will still apparently heat healthy tissue. As seen above, the applied temperature is quite high. Furthermore, there appears to be no suggestion to direct helical antenna radiation towards a particular radial segment of the artery. U.S. Pat. No. 5,370,677, issued Dec. 6, 1994, to Rudie et al. discloses a transurethral substantially helical microwave antenna catheter operating at about 915 MHz for thermal treatment of benign prostatic hyperplasmia (BPH). Directional application of heat is accomplished in the range of 45° C. to 60° C. by placing the antenna offset from the axis of the shaft. The heating process takes a period of about 45 minutes, to necrose or ablate, tumorous prostate tissue while a catheter water cooling jacket keeps temperatures adjacent the catheter below about 45° C. to protect adjacent healthy tissue such as the urethra, ejaculatory duct and rectum. The necrosed tissue is reabsorbed by the body. Dilation of a coronary artery is not disclosed. U.S. Pat. No. 5,359,996, issued Nov. 1, 1994, to L. L. Hood, discloses an ultrasonic cutting tip assembly for an ultrasonic cutting instrument having an ultrasonic transducer. U.S. Pat. No. 5,199,951, issued Apr. 6, 1993, to J. R. Spears, discloses a balloon angioplasty method for treating a lesion in an arterial wall by bonding a bioprotective material thereon with temperatures in the range of 80° C. to 100° C. for about twenty seconds with another twenty second wait before the balloon is deflated. The bioprotective coating is used to coat the endothelium while it is repairing itself after balloon angioplasty as well as provide drug carriers for the artery to alleviate problems of restenosis and thrombus. U.S. Pat. No. 5,109,859, issued May 5, 1992, to R. D. Jenkins, discloses a laser ablation catheter system guided by ultrasound sonography to remove atherosclerotic plaque from coronary arteries. U.S. Pat. No. 5,057,106, issued Oct. 15, 1991, to Kasevich et al., discloses a balloon angioplasty microwave catheter system used for heating arterial plaque. The patent teaches that heating of the plaque reduces restenosis and that the plaque should preferably be heated to about 100° C. for about 30 seconds using a 10 GHz microwave source. U.S. Pat. No. 4,927,413, issued May 22, 1990, to R. Hess, discloses a flexible shaft for use with balloon angioplasty. U.S. Pat. No. 4,881,543, issued Nov. 21, 1989, to Trembly et al., discloses a microwave applicator for heating stroma at 2.45 GHz to effect shaping of the cornea with apparatus for cooling of the cornea to protect the endothelium by flow of saline transverse to the antenna axis. U.S. Pat. No. 4,808,164, issued Feb. 28, 1989, to R. Hess, discloses a catheter for balloon angioplasty that includes a flexible shaft defining a hollow passage. U.S. Pat No. 4,700,716, issued Oct. 20, 1987, to Kasevich et al. discloses a microwave antenna for treatment of tumors or other materials by hyperthermia with temperatures of about 50° C. induced with microwave frequency in the range of 500 MHz to 5 GHz. There does not appear to be any provision for protecting endothelial cells from damage. U.S. Pat. No. 4,685,458, issued Aug. 11, 1987, to M. E. Leckrone, discloses a catheter for use in removing undesired material from a duct with a patients's body including a cutting element, an inflatable bladder, and a pair of abutments to surround the material being removed so that the material is vacuumed out through the catheter. U.S. Pat. No. 4,643,186, issued Feb. 17, 1987, to Rosen et al., discloses a balloon angioplasty catheter with microwave antenna to heat and soften the plaque by radiation and heat convection. No particular frequencies are provided and no particular precaution is provided for the endothelium. U.S. Pat. No. 5,129,396, issued Jul. 14, 1992, to Rosen et al., discloses a balloon angioplasty catheter with microwave antenna to measure balloon distension. U.S. Pat. No. 4,576,177, issued Mar. 18, 1986, to W. W. Webster, Jr., discloses an optical fiber for transmitting laser radiation and an ultrasonic transducer mounted at the tip of the catheter for transmitting and receiving ultrasonic signals. U.S. Pat. No 5,150,717, issued Sep. 29, 1992, to Rosen et al., discloses an angioplasty catheter that includes a coaxial transmission line with an elongated center conductor and outer conductor. The transmission frequency is preferably about 3 GHz. U.S. Pat. No. 4,998,932, issued Mar. 12, 1991, to Rosen et al., discloses a chip generator for either laser or RF radiation located on the distal end of the catheter. U.S. Pat. No. 5,607,419, issued Mar. 4, 1997, to Amplatz et al., discloses a catheter to apply UV light to a blood vessel after balloon angioplasty. The patent teaches that this treatment retards growth of smooth muscle cells. I.E.E.E. Transactions on Biomedical Engineering. Vol. BME-34 No. Feb. 2, 1987, by D. M. Sullivan, D. T. Borup, and O. M. P. Gandhi, entitled “Use of Finite Difference Time-Domain Method in Calculating EM Absorption in Human Tissues” describes the FDTD method as applied to bioelectromagnetic problems and demonstrates a 3-D scan of the human torso. I.E.E.E. Transactions on Biomedical Engineering, Volume 35, No. Apr. 4, 1988, by D. Andreuccetti, M. Bini. A. Ignesti. R. Olmi. N. Rubino, and R. Vanni, entitled “Vee and Polyacrylamide as a Tissue Equivalent Material in the Microwave Range”, discloses the use of polyacrylamide gel to simulate biological tissues at microwave frequencies. Other related references include Critical Reviews in Biomedical Engineering, by K. R. Foster and H. P. Schwan, Volume 17, Issue 1, 1989, entitled “Dielectric Properties of Tissues and Biological Materials” and the book “Field Computation by Moment Methods”, by R. F. Harrington, MacMillan Press, 1968. A review of the above references reveals that a long felt need exists for apparatus and methods to dilate the lumen of the artery without injuring endothelial cells so as to avoid the long term problems often associated with trauma thereto. If the atherosclerotic lesions are radially external of the intima, e.g., in the media, then the intimal layer including the endothelium should be preserved from injury. At a bare minimum, the energy for softening fatty deposits should be radially directed toward the segment or arc of the artery in which the atherosclerotic lesion is located, if the lesion is asymmetrically located within the arterial wall, to greatly reduce the likelihood of damage to healthy tissue. Healthy tissue in the adventitial layer should be preserved. A temperature profile should be controlled to produce heat in a region corresponding to the size and position of the atherosclerotic lesion. The heating should preferably be effected very quickly to avoid extended blockage of the artery with the catheter. Those skilled in the art have long sought and will appreciate the present invention that provides solutions to these and other problems. SUMMARY OF THE INVENTION The present invention provides methods and apparatus for thermally necrosing (ablating) connective tissue and softening plaque within atherosclerotic lesions while controlling the temperature rise in other arterial tissues and in the endothelial layer of the artery. By means of the present invention, the time required to raise the temperature of an atherosclerotic lesion by a sufficient level (about 20° C.) is usually less than one second. The lesion is heated while limiting damage to other tissues. The microwave power level of operation and frequency is chosen so that a temperature increase from absorption of microwave energy in the endothelium is limited by the blood exchange rate to a desired safe temperature range. The frequency of operation and other factors affect the depth at which energy is deposited. Heat conduction effects are related to the time period of operation. As used herein unless otherwise stated, ablation or necrosis refers generally to creating a temperature profile in the biological tissue that results in a cessation of biological functioning of the remaining living or diseased cells in the tissue, such as connective tissue, that is part of the plaque in the artery wall. For instance, thermal ablation or necrosis refers to heating cells by about 20° C. to the general range of roughly 57° C. (which temperature may vary and is often dependent on the heating duration) to cause them to cease biological functioning Once ablated or necrosed, any connective cell tissues within and/or encapsulating the plaque will no longer mechanically support the arterial wall. The absence of mechanical support by the connective tissue induces the lumen in the region or sector of the atheroma to be more flexible in response to the arterial pressure, and especially the elevated arterial pressure at the restriction. Without connective tissue, flesh has the approximate tensile strength of Jello®. However, care must be taken that healthy arterial smooth muscles are not also damaged to the extent that aneurysms are likely to form. Excessive heating of healthy tissue could result in dilation that escalates because greater arterial surface area results in a larger force that may then cause increased dilation, and so on. According to the present invention it is not necessary or desirable to vaporize or char cells for ablation purposes because overheating may cause undesirable side effects. The heating profile is conservatively controlled where possible within time constraints to limit overextending the artery so as to induce aneurysms in the long term. Therefore, the procedure may be performed in stages to attempt to avoid such effects. The temperature profile size and shape may be predicted by computer simulation and effected by microwave radiation having controllable characteristics including frequency, antenna power, pulse width (heating time), and beam width. For this purpose, a method is given for thermally heating an atherosclerotic lesion in an artery to treat atherosclerosis while preserving an endothelial layer of the artery. A catheter is provided that has a microwave radiator at one end thereof. A frequency of operation for the microwave radiator is provided within a frequency range of from about 3 Gigahertz to about 300 Gigahertz. A microwave power level of operation, pulse duration of operation, and frequency of operation is used such that a heat rise from energy deposition in the endothelial layer is limited by a blood flow rate and a specific heat of the blood to within a selected temperature rise less than an amount that will damage the endothelial layer. The frequency is selected so that a profile of the heat rise due to energy deposition is maximum within in the atherosclerotic lesion as compared to tissues and fluid surrounding the atherosclerotic lesion. Typically, a pulse duration of operation of less than two seconds is required for necrosina living tissue within the atherosclerotic lesion. In many cases, the pulse duration will be less than one second or less than one-half second. The microwave radiation is directed at a radial segment of the artery in which the atherosclerotic lesion is substantially positioned, because, typically, the lesions are asymmetrically disposed around the arterial lumen. It is undesirable to apply heat to the remaining healthy tissue opposite or adjacent the lesion. Therefore, a radially directable energy source is provided for use in directing microwaves towards the particular sector of the artery wherein the lesion is located. In one preferred embodiment wherein a waveguide antenna is used, the frequency of operation is in the range of 30 GHz to 300 GHz. The waveguide antenna is preferably a radically beveled open ended waveguide antenna. In another embodiment, frequency in the range of 3 GHz to 300 GHz is generated using a chip positioned on a distal portion of the catheter. Presently available MMIC chips cover a range of 50 to 110 GHz with more power per chip being available at the lower end of the spectrum. To achieve greater than one watt of power, it may be necessary to sequentially connect two or more of the chips together to increase radiation power from the catheter. Preferably, microstrips are used to connect the chips, if necessary, to thereby prevent increasing the diameter of the catheter. The transcatheter method of dilating the artery includes steps such as positioning the catheter within the artery adjacent to the atherosclerotic lesion, radiating the atherosclerotic lesion with sufficient energy to raise the temperature thereof, and controlling temperature in the endothelial layer to a temperature that does not injure the endothelial layer by limiting total energy deposited in the endothelial with respect to heat lost due to conduction and convection of fluid flow through the artery. After sufficient energy is deposited in the atherosclerotic lesion to necrose living tissue therein and increase flexibility thereof the natural arterial pressure is used or allowed to dilate the artery. By radiating the energy toward a radial segment of the arterial wall in which the atherosclerotic lesion is positioned, the radiated energy deposited outside of the radial segment of the arterial wall in which the atherosclerotic lesion is positioned is greatly reduced or eliminated. While the connective tissues are necrosed, the plaque that includes wax and fatty deposits is also softened thereby further increasing flexibility of the artery. A temperature profile for deposition of the energy within the wall of the artery may be predicted using a computer program. The program simulates transcatheter microwave antenna temperature control within an arterial wall having an atherosclerotic lesion therein. Although it may be desirable to start with information about the position of the lesion, characteristics thereof and so forth, and obtain operation periods, frequencies and so forth, it is also possible to provide such information to determine the temperature profile. Thus, a frequency of operation from 3 GHz to 300 GHz, the power input, heating time, and antenna beam width may be input to achieve the desired temperature profile. Generally, the program will determine heat energy transferred by heat conduction within a plurality of layers and determine heat energy removed by fluid flow through the artery. For visual ease, it will normally be desirable to plot at least one cross-section of temperature profile in the arterial wall. If the atherosclerotic lesion is asymmetrically disposed within the artery, it is necessary or at least highly desirable to determine the radial section in which the atherosclerotic lesion is located. The size of the atherosclerotic lesion may be an input to the program. The program will model characteristics of the atherosclerotic lesion using a plurality of computer cells of a small size which can simulate the characteristics of a material within the atherosclerotic lesion being provided for each of the computer cells. e.g., electrical permittivity and conductivity at the frequency of operation and thermal conduction properties. Because the lesions are heterogeneous, such values may vary for each of the plurality of computer cells. The energy added to computer cells, that represent portions of the simulated arterial wall, is determined by energy entering and leaving the computer cells. The isothermic profile is determined for a particular time period preferably within a desired time period range of less than five seconds. The profile at any time will vary significantly due to heat conduction and energy deposited. The isothermic profile varies significantly for any particular frequency within a desired frequency range of from 3 GHz to 300 GHz. The microwave waveguide embodiment of the invention is preferably used with a catheter comprising a microwave transmission line having first and second opposing ends wherein the first end is adapted for connection to a microwave power source having a frequency of operation between about 25 or 30 GHz to about 300 GHz. At least a portion of the microwave transmission line should be operable as a microwave waveguide such that the microwave waveguide has an outer conductor defining an inner region filled with homogenous dielectric material. The microwave radiator is then disposed at the second end of the microwave transmission line. The microwave radiator preferably comprises an open ended waveguide antenna having a beveled portion of the outer conductor of the antenna. The beveled portion is beveled with a selected angle so that energy is directed radially from the open ended waveguide antenna. Dielectric material disposed at the beveled portion preferably extends towards a termination end of the antenna. In one embodiment, the inner region is filled with dielectric material that forms an axial extension that extends beyond the beveled portion so as to be operable for exposure to the artery. The microwave transmission line may include a coaxial portion having an inner and outer conductor and a transition portion between the coaxial portion and the microwave waveguide. Continuous microwave radiation is preferably limited to less than five seconds and, generally, much less. In another embodiment, a monopole antenna is provided and, more specifically, includes a double disk loaded monopole antenna. It is an object of the present invention to provide an improved method for dilating an artery without harming the endothelial layer or healthy tissues. It is a further object of the present invention to provide a technique for conveniently predicting isothermic region sizes and shapes from power inputs, antennas, frequencies of operation, time duration for heating, and other relevant factors that affect the transfer of heat energy. Yet another object is to limit restenosis by limiting damage to the artery during a procedure for opening the artery. Yet another object is to take advantage of new tools that describe the lesions more clearly so that treatment can be tailored in response to information about the particular situation. Yet another object of the present invention is to provide a test device that allows a close approximation of the actual physical structures within the body by which the various devices and heating factors can be tested in a realistic setting for purposes such as verifying predicted results as to heating, gathering data, refining techniques, and the like. A feature of the present invention is a transcatheter heating instrument that includes presently preferred embodiments for a microwave radiator. Another feature of the present invention is a range of frequencies of operation shown to be especially useful for supplying energy to atherosclerotic lesions. Another feature of the present invention is a simulation for determining microwave radiation and the resulting temperature effects in the blood/tissue/plaque environment due to the heterogeneous nature of this environment including the atherosclerotic lesion. An advantage of the present invention is the wide range of factors that can be adjusted to consider prediction of future results. Another advantage of the present invention is the ability to refine techniques both before actual construction and after actual construction of the particular devices to be used. Another advantage of the present invention is that long term problems associated with damage to tissues such as endothelial cells from the procedure is limited. Yet another advantage of the present invention is the ability to tailor and otherwise refine apparatus and/or techniques to the requirements of a particular application. These and other objects, features, and advantages of the present invention will become apparent from the drawings, the descriptions given herein, and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram showing a system for treating atherosclerosis; FIG. 2 is an elevational view, partially in section, showing a radically beveled circular waveguide antenna; FIG. 3 is an elevational view, in section, showing a double disk loaded monopole antenna; FIG. 4 is a graph of temperature to tissue depth showing the temperature equilibrium and percentage of energy deposited though 400 microns of 5 cubic millimeters of muscle tissue for a 0.5 second pulse duration with one watt antenna power and a frequency of 95 GHz; FIG. 5 is a graph with variables being essentially the same as those of FIG. 4., except for a frequency of operation of 40 GHz; FIG. 6 is a schematical representation of an isothermal temperature profile produced in 1.68 mm 3 of myocardium tissue in 0.299 seconds of heating as a function of distance along an antenna at 95 GHz: FIG. 7 is a schematical representation of an isothermal temperature profile having substantially the same variables with the frequency being 40 GHz; FIG. 8 is a schematical representation of an isothermal temperature profile having substantially the same variables with the frequency being 15 GHz; FIG. 9 is a chart showing a simulated artery wall temperature profile at 15 GHz for 1 second wherein each line represents a layer and wherein layer 16 , corresponding to 320 microns, indicates a peak temperature in the media and a temperature profile that saves endothelial cells and prevents thermal damage to cells of the adventitia; FIG. 10 is an schematical representation of another embodiment of the transcatheter of present invention using small chips for generation of the microwave signal; FIG. 11 is a diagram representing a typical progression of atherosclerosis leading to a complicate lesion that ulcerated and developed thrombosis; and FIG. 12 is a diagram that relates to the general structure of the arterial wall including the endothelium and intimal layer, media, and adventitia. While the present invention will be described in connection with presently preferred embodiments, it will be understood that it is not intended to limit the invention to those embodiments. On the contrary, it is intended to cover all alternatives, modifications, and equivalents included within the spirit of the invention and as defined in the appended claims. DESCRIPTION OF PREFERRED EMBODIMENTS The techniques of the present invention are designed to treat atherosclerosis without damaging the important endothelial layer. Once the catheter is positioned, the heating of the atherosclerotic lesion takes little time, in some cases less than one-half second. The power levels are low—in the range of about 1 watt. The catheter is designed to operate while blood continues to flow through the artery. A temperature profile is produced in the arterial wall that necroses or ablates connective tissue, softens waxes and fats, and allows the arterial pressure to more gently act to dilate the artery. Frequency of the radiation has a significant affect on the depth of maximum energy deposition. The beamwidth can be selected to be in accord with the size of the lesion. Where the lesion(s) are asymmetrically disposed in a specific arc of the arterial wall, the energy is directed toward the arc and the angle of focus for the radiator can be adjusted accordingly. This provides much more efficient use of the energy, making the procedure quicker. It also protects the remainder of the healthy tissue from being overheated. Therefore, radiation is preferably more specifically tailored to concentrate energy within the atherosclerotic lesion based on the position and depth thereof, as well as the size and shape of the lesion. As more improved information becomes available by ever improving technology about the more precise structure of the lesion, such as with MRI and CAT scans, the information can be used to further refine predictions when computing temperature profiles through the computerized modeling techniques disclosed, as discussed further in regard to the computer simulation program. Furthermore, the test assembly of the parent of this application may be used to quite realistically test the instrument using damaged arterial segments so that extensive experience and training can be obtained prior to use. As a general background. FIG. 11 discloses the progressive nature of atherosclerosis with a variable time line in terms of age. Artery 1110 is initially free of lesions or fatty tissue so that lumen 1114 is completely open. Between very roughly the age of 15 to 30, fatty streaks 1115 begin to develop as shown by artery 1120 . These fatty streaks may disappear as indicated by the double arrows between artery 1110 and 1120 . Thus, the body has the ability to reabsorb fatty streaks, to some extent. Over age 30, waxy and fibrous tissue or atheroma 1118 forms as indicated in artery 1130 . The atheroma 1118 , or atherosclerotic lesion, shown in artery 1130 , is in the uncomplicated state, or non-thrombotic state, that leaves some lumen, however narrow. The waxy, and especially the fibrous tissue does not normally disappear as frequently as did fatty streaks 1115 . Without assistance of some type, the body has less ability to reabsorb such tissue. At some time, very roughly in the age range of 40 to 80, a complicated lesion 1124 , with plaque that typically also includes calcification, as indicated in artery 1140 may occur. The body tends to have little ability to reabsorb the calcification although some pharmacological treatments exist wherein the goal is to assist the body to effect reabsorption of calcified plaque. Complicated lesion 1124 is considered complicated because it may be hemorrhaged, ulcered, calcified, or thrombogenic, and may produce a heart attack, or myocardial infarction, due to blockage of blood flow. In this case, thrombus or blood clot 1122 has formed to block artery 1140 . Therefore, as the disease slowly progresses, trauma to the endothelial layer may occur that results in a complication. For instance, if blood is then exposed to collagen tissue that typically encapsulates the plaque, and/or for the numerous other reasons discussed hereinabove, blood clot such as thrombus 1122 may develop that closes the artery lumen and results in a heart attack due to the heart muscle not receiving sufficient, or any, blood flow. Obviously, it is preferable that treatment begin prior to the complicated or occlusive stage of artery 1140 . Such treatment may be directed to slowing down the atherosclerotic processes involved and may involve dieting, monitored exercising, lowering cholesterol, decreasing blood pressure, and the like. If the lumen needs to be dilated to obtain sufficient blood flow to the heart muscles, and pharmacological means are unable to provide suitable relief, means as discussed hereinafter may be used to dilate the lumen while attempting to maintain the important healthy aspects of the artery. It will be observed that often, as shown, atherosclerotic lesions are asymmetrical, as indicated in artery 1130 . In accord with the present invention, the healthy tissue not affected by atherosclerosis should be protected and not be placed under stress. Any healthy tissues that are damaged in the process of dilating the lumen may become involved in processes of restenosis wherein a relatively rapid reclosure of the artery may occur within one year or so after the dilation procedure. According to the present invention, plaque is preferably heated so as to soften and melt it. After heating, the plaque volume or volume of the lesion may be somewhat reduced and some plaque components, such as the fatty elements, may perhaps be reabsorbed to a certain degree. The heating also necroses or ablates connective tissue so that the arterial lumen can dilate due to natural arterial pressure. Without the aid of connective tissue, flesh loses connective strength and may be similar to a paste or gel in overall tensile strength. Care also needs to be taken to not ablate too much tissue surrounding the artery. If the artery has insufficient strength, it may become subject to problems of aneurysms. As noted previously, the possibility of aneurysms can also be a long term problem associated with balloon angioplasty treatment. Apparently, simply opening the diameter of the lumen is not, in itself, necessarily the cause of restenosis. By avoiding damage to healthy tissue including the endothelium, it is expected that this technique will alleviate some, and perhaps many, of the processes of restenosis. However, it will be recognized that essentially dilation procedures are simply delay procedures that permit improved blood circulation while, hopefully, the underlying causes of the atherosclerosis, which may be many causes, are alleviated. However, because restenosis tends to proceed at a much faster pace than the underlying problem of atherosclerosis, restenosis remains a very significant barrier to successful long term treatment of atherosclerosis. It is therefore a basic goal of the present invention to alleviate problems of restenosis while dilating the artery. FIG. 12 discloses the general make up of a healthy arterial vessel wall in greater detail disclosing the cellular layers of tissues and provides, very approximately, the width in microns of the cellular layers in an average healthy vessel wall. The values of the width of the vessel wall may change significantly for a vessel wall having an atherosclerotic lesion in it. Plaque tends to somehow make its way into and to build up within the intimal and/or medial layers, apparently due to numerous processes that may underlie the atherosclerosis. The intimal layer includes the endothelium layer wherein endothelial cell 1212 is indicated and an additional layer of cellular tissue 1214 . As discussed previously, blood does not clot when in contact with the endothelial layer but has a tendency to do so when it comes into contact with many other types of tissues such as those found within plaque, e.g., collagen or connective tissue. Such tissues are highly thrombotic. Protection of the endothelial layer is therefore very important and, if it remains healthy, will probably aid in preventing or slowing of numerous of the processes of restenosis, as well as the processes involved in atherosclerosis. Internal elastic membrane 1216 separates the intimal layer from medial layer that includes smooth muscle cells 1222 . Adventitial layer 1224 provides for lymph drainage and blood flow within the arterial wall. The lumen is located adjacent intimal layer and defined by the endothelium, in the health artery. Atherosclerotic lesions are found within the vessel wall, generally in the intimal or medial layers. It is desirable to apply heat to the lesion without traumatizing the surrounding tissues, including the endothelium and adventitial layers. Where possible, it is desirable to protect the healthy intimal layer and/or medial layers when the lesion has not formed therein. Therefore, a system is necessary for developing a controllable temperature profile that maximizes heat within the lesion and wherein the temperature drops off quickly outside the lesion to avoid damage to healthy tissue. Referring now to FIG. 1, the major components of system 10 disclose a preferred embodiment of the present invention for treating atherosclerosis. Generally, system 10 includes a millimeter wave/microwave power source, a catheter transmission line in the form of a waveguide, coaxial cable or combination of the two, and an antenna/radiator located at the end of the catheter. Another type of catheter without a microwave transmission line is also shown as an alternative embodiment in FIG. 10 and is discussed hereinafter. Power source 12 is capable of producing up to 10 watts at a controlled power level. However, generally the power required may be considerably less if the atherosclerotic lesion is asymmetrically oriented and depending on the size thereof. It is presently anticipated that heating will generally be sufficiently effected at levels closer to about one watt, depending on the volume of the lesion. The subsequently shown test results are normally based on an antenna power of one watt or less. Power level control 14 is used to adjust the antenna power to the desired level. Power source 12 supplies power at the desired frequency, which as shown hereinafter, can be used to control the temperature profile. Selected frequencies for the present invention, depending on the application as discussed hereinafter, are in a range from 2 GHz to 300 GHz. It is presently anticipated that a separate power source would preferably be used or required for each frequency selected. Pulse duration control 15 provides a pulse that controls the time that antenna power is applied. In the present embodiment, pulse duration control 15 is arranged to be pulsed with a desired pulse duration of from 0.1 to 10 seconds, with the accuracy of the pulse duration controlled within 2%. As will be seen subsequently, the pulse duration was less than about 0.5 seconds during the tests for anticipated volumes of lesion size which were for asymmetrically spaced atheromas. As discussed subsequently, the necessary power can be applied more quickly, or efficiently, if the asymmetrical nature of the typical atherosclerotic lesion is taken into consideration. Not only is heating time reduced thereby limiting treatment time to a desirable minimum, but also healthy tissue is spared. The pulse duration may be increased or decreased as necessary and precision of the pulse length could be narrowed, if desired although the small 2% variation in pulse duration is not anticipated to significantly affect the thermal profile produced. Directional coupler 16 is used to match impedances for more efficient application of power to the antenna. Forward/reflected power monitor 18 detects if a mismatch has occurred such that power is not being radiated from the antenna with sufficient efficiency. In that case, power will not be radiated efficiently and therefore power source 12 may be shut down automatically. Catheter 20 provides a means of directing energy from power source 12 to antenna 22 . At the higher range of frequencies from approximately 25-30 GHz to300 GHz, it is likely that a flexible waveguide would provide the most efficient means of power delivery. At the lower frequencies, from approximately 2 GHz to 25-30 GHz, a coaxial cable will probably be preferable for efficiency of power delivery. In some cases, it may be desirable to have a coaxial cable for a portion of catheter 20 formed of coaxial cable and a portion formed of waveguide. If that proves to be desirable as may occur for flexibility purposes, cost, convenience or other reasons, then an impedance matching transition member, such as transition member 24 , may be used to connect between the coaxial cable portion and the waveguide portion. In yet another embodiment, such as that discussed in the embodiment of FIG. 10, it may be preferable to locate the millimeter wave source directly behind the antenna, thereby reducing transmission line losses. Antenna design is also preferably made dependent of the selected frequency of operation. For operation in the higher range of frequencies, the presently preferred embodiment of the invention would use a radically beveled open ended waveguide antenna, as shown in FIG. 2, and discussed hereinafter. The radically beveled antenna produces a radiation beam that is directed to a selected arc of the lumen. For frequencies at the lower end of the frequency range, disk loaded monopole antennas, as shown in FIG. 3, have proven to be effective. Disk loaded monopole antennas are discussed in some detail in the parent to this application, which application is incorporated by reference herein. At the low end of the frequency range, antennas tend to radiate much more broadly. Therefore, such antennas may be more suitable when the cross-sectional distribution of lesion(s) is of the type sometimes referred to as a circumferential lesion that yield a central lumen completely surrounded by a circumferentially distributed lesion. More commonly, an eccentric atheroma is found that yields an eccentric lumen. For this reason, the radically beveled open ended antenna that operates in the higher range of frequencies may be preferable. For this and other reasons discussed hereinafter, a choice of 95 GHz was made for the initial test program in which selected arteries, in vitro, will be heated via a transcatheter antenna. It will be noted that the eccentric lumen may be subdivided further into categories including a slitlike or circular lumen with the circular lumen being positioned eccentrically within the cross-section of the artery. There are numerous variations in between, depending largely on the size of the arc of the lesion. The slitlike lumen may have a lengthwise diameter almost as wide and the original lumen. Therefore, adjustment of the beamwidth of the antenna may be used, as discussed subsequently, or some additional rotation of the antenna may be used, to heat the desired portion or all of the atheroma. FIG. 2 discloses a presently preferred radiator for the higher frequency range of from about 25-30 GHz to 300 GHz in the form of a radically beveled circular waveguide antenna 200 . Waveguide material 210 is preferably a low loss ceramic material that is suitably flexible for use in a catheter. The waveguide antenna and waveguide preferably have a diameter 224 of about two millimeters and is circular. Metallic sheath 214 is cut and removed to provide for a radical bevel 212 . Metallic sheath 214 conforms and surrounds waveguide material 210 . The angle of bevel 212 affects the width of the directional beam 218 , indicated in dash, produced by antenna 200 so that a smaller angle with respect to the longitudinal axis of the antenna produces a wider beam. A minimum and maximum angle may be used depending on variables related to the losses at beveled interface 220 . As indicated, directional beam 218 is directed radially outwardly from beveled interface 220 . As discussed hereinafter in regards to the computational simulation, beam 218 , depending on the type of antenna, may be a focused beam, a spreading beam in one direction, or a spherically spreading beam. The beam of the waveguide antenna may be a focussed beam without significant spreading although, for illustrative purposes only, some spreading is indicated as may be possible to produce depending on the angled cut of the bevel. A selected beamwidth with appropriate spreading tendencies is desirable and necessarily depends on the size and location of the lesion in the wall. Tip 216 may be formed of waveguide material 210 and preferably extends past radical bevel 212 in metallic circular cross-sectioned sheath 214 . Tip 216 may also be formed of a different dielectric material selected for loading purposes. However, construction of antenna 200 may be simplified somewhat if the same waveguide material 210 is used. A medically acceptable nonthrombogenic material is used to form sheath 222 of the catheter. Federal regulations presently require use of a new catheter for each procedure rather than allowing sterilization and reuse of the same catheters. This factor may make it possible to provide for variations in the catheters and the catheter antennas to match the particular usage of size and shape of the lesion without any substantial increase in cost. FIG. 3 discloses a double disk loaded monopole antenna 300 in accord with the present invention. The general construction features of such an antenna are covered in some detail in the parent of this application so that only the basic features are covered herein. Antenna 300 is essentially simply a smaller antenna than the antenna disclosed in the parent, and reference is made to the earlier patent that is incorporated herein by reference. Antenna 300 is connected to coaxial cable portion 310 . Coaxial cable 310 comprises an outer metallic conductor 312 and a centrally located conductor 314 . Insulator material such as TEFLON® or other suitable material forms the core 316 of coaxial cable 310 and also preferably extends into antenna 300 . To limit current flow along the catheter, metal choke 318 is employed. Insulative jacket 320 is provided on the catheter but is cut off at the beginning of metal choke 318 so that radiation may occur, mainly from the discontinuities of antenna 300 starting at the beginning of gap 322 . Gap 322 is related to the frequency of operation. The second and third discontinuities include tuning disk 324 and disk 326 . Tuning disk 324 may be used to adjust the center frequency of operation of the antenna so as to flatten the response over the bandwidth of operation, which tends to be fairly broad. Antenna 300 is preferably used for lower frequencies such as the range from 2 GHz to 25 or 30 GHz radiation proceeds outwardly in all directions from antenna 300 and therefore antenna 300 is preferably used for treatment of circumferentially disposed atherosclerotic lesions. Referring to FIG. 4, in operation at frequencies above 40 GHz, most energy is deposited within the atherosclerotic lesion and little energy will pass into and beyond the adventitial layer because of rapid decay of the electromagnetic wave. The frequency used in the chart of FIG. 4 is 95 GHz. The maximum temperature rise for the example of FIG. 4 occurs at about 132 microns as indicated by heavy line 410 which represents the temperature profile as a function of depth. The heating time is 0.5 seconds and the volume heated is 5 cubic millimeters. The antenna power is 1 watt. A focused beam is used and the maximum temperature increase is approximately 12 degrees for the example of FIG. 4 . The material used for testing is beef heart muscle. Keeping all variables the same except frequency, the maximum temperature rise for the situation of FIG. 5 occurs at 246 microns, therefore indicating the significant effect that changing only frequency has on the temperature profile. For a focused beam antenna, power absorption decreases as exp (−2αr) where α is the attenuation constant, and r is the distance from the antenna. This exponential decay is indicated by the thin line 412 in FIG. 4 that indicates the relative deposition rate of energy as a percentage. For a very broadly radiating antenna, power absorption decays as exp (−2αr)/r 2 . The decay is more rapid because of spherical beam spreading resulting in the r 2 term in the denominator. Therefore, when a broad beam radiator is used for radiating an asymmetrically disposed lesion, only a portion of the radiated energy is used so that generally only a portion of the lesion is illuminated. The extraneous energy is wasted or produces heating of non-diseased tissue or proximal blood. Except for circumferentially diffused lesions, a focused beam is therefore preferred. In addition to electromagnetic heat deposition, thermal conduction plays a critical role in obtaining the desired temperature profile within the arterial wall. At any depth within the wall, thermal equilibrium is reached when the heat gained by electromagnetic deposition is equal to the heat lost by the heat loss mechanisms. At the internal surface of the artery. i.e., the endothelial layer, heat lost by conduction and convection to the flowing blood as well as heat lost by conduction to the outer layer of the transcatheter antenna, will prevent any significant temperature rise. As indicated in FIG. 4, heat rise for the first 20 microns is zero. The maximum heat rise over the endothelial layer, of approximately 30 microns, is only about 2 degrees centigrade. At shallow depths within the intimal layer, temperatures are depressed by strong thermal conduction to the blood due to the relatively short distance thereto. At deeper depths, temperatures rise until a depth of maximum temperature is reached. In the chart of FIG. 4, the maximum temperature is reached at 132 microns from the surface of the vessel. By adjusting the frequency, beam width, pulse time, and power, the maximum temperature can be placed at the center of the atherosclerotic lesion. At depths beyond the lesion, temperatures drop because electromagnetic deposition, as indicated by thin line 412 , is significantly diminished. Therefore, in the example of FIG. 4, the adventitial layer and much of the muscle tissue of the medial layer is well preserved. In the example of FIG. 5, where all the controlled variables are the same, i.e., power delivered, pulse duration, and antenna bandwidth, the maximum temperature occurs at 246 microns as indicated by temperature profile thick line 510 , which is typically well beyond the intima and into the media where many lesions occur. Thin curve 512 discloses a more flattened energy deposition curve. In both cases, the important endothelial layer is well preserved. Temperature profiles can be customized to the size, shape, and type of the lesion. The controllable factors that determine the temperature profile are the following: (1) antenna power delivered, (2) pulse length, (3) frequency, and (4) antenna design/beamwidth control. A computer program simulation has been written that calculates the three dimensional isothermal contours for a given frequency, power level, pulse duration, antenna type, tissue complex permittivity and tissue constants. Examples are shown in the isothermal type printouts of FIG. 6 -FIG. 8 . It will be noted that the program can be used with heterogenous tissues that are typical with atherosclerotic lesions, although in the present examples the tissue is assumed to be homogenous. It is anticipated that testing with actual atherosclerotic tissue in the test unit will refine the values used. e.g., for thermal conductivity and conductivity. As well, test information about the particular situation available or that may become available in the future due to advances such as refined MRI photos may be of value in refining the data for particular cases. In FIGS. 6, 7 , and 8 all variables are kept constant except frequency, although the isothermal regions viewed in FIG. 8 are twice as large. The type of printout shown is a sectionalized isothermal profile although other types of printouts could be used or different views could be projected. These particular views are shown for example only. In FIG. 6, the computer simulation uses a frequency of 95 GHz. In FIG. 7, the selected frequency is 40 GHz and in FIG. 8, the selected frequency is 15 GHz. The large plot on the left in each figure shows the heating of a cube of myocardium with half of the cube cut away in the z direction to show the isothermal profiles in the x-y plane. The eight individual cross-sections shown on the right are artificially expanded in the y direction so that the isothermal profiles in the x-y plane can be observed. It will be seen that the results from the computer simulation are similar to that shown in the physical testing as per the charts of FIG. 4 and FIG. 5 . An increase in frequency, keeping all other variables constant, tends to move the center of the position of maximum temperature closer to the antenna. This is seen by reviewing regions 616 , 716 , and 816 that of the respective FIG. 6, 7 , and 8 that indicate regions having temperature increases between 15 and 20 degrees Kelvin. The regions of relatively moderate increases, i.e. 612 , 712 , and 812 for temperature increases between 5 and 10 degrees Kelvin, and 614 , 714 , and 814 for temperature increases between 10 and 15 show a somewhat similar shift in the same direction. The coolest regions are those of 610 , 710 , and 810 that reflect regions having a temperature increase less than 5 degrees Kelvin. The individual cell size selected for this particular display is 100 microns on a side (200 microns on a side in FIG. 8) and therefore provides an overview of a relatively large area for easy viewing of the overall effects throughout the simulated lesion volume. The entire field size is about 1800 microns on a side for FIG. 6 and FIG. 7, and 3600 microns for FIG. 8 . In the isothermal segments of FIG. 6 and FIG. 7, the side in the x direction is 1800 microns wide and the side in the y direction is 900 microns. If desired, much smaller regions, such as the approximately 30 micron depth of the endothelium, could be emphasized in greater detail to provide a picture of heating in the endothelial, intimal, medial, or any other portion of the arterial wall. However, it will be noted that the larger scales are quite useful when an overview is desired. FIG. 9 is a printout that provide some relatively detailed feedback from the computer simulation regarding this region and any of about 50 different sections, as discussed hereinafter, although the focus of the simulation printout can be varied as desired. Other graphs such as the temperature profile versus depth for various times during the heating period may be printed out. The plots may be in color. Additional information may be printed on each plot including values such as cell size, final temperature profile, type of antenna radiation, number of cubic millimeters at various selected temperature ranges, total energy in the cube after the power pulse, antenna radiated power, the number of computational cells illuminated, and so forth. Comparing information regarding FIGS. 6, 7 , and 8 , the volume of material having a 10° C.-15° C. rise is greater for 40 GHz and less at both 95 GHz and 15 GHz. The time of the pulse in each case was 299 milliseconds. For short duration times of power application, the blood temperature at the surface of the lesion near the antenna rises with increasing frequency. The maximum temperature in the lesion moves to shallower depths with increasing frequency. Also the maximum temperature in the lesion increases with increasing frequency. One basic premise shown from FIGS. 6, 7 , and 8 is that heat contours can be significantly customized by frequency selection alone. Further customization is accomplished by selection of power level, duration of power delivery, and antenna type. The computer simulation can readily show the effects of such changes. The simulation results can be compared with information obtained from the test setup as discussed in the parent wherein temperature profiles, blood flow, type of vein, and so forth can be realistically determined, even prior to in vivo testing. In a presently preferred embodiment of the simulation, a computational “myocardium” or heart tissue cube having a size that correlates to a region of tissue to be ablated is given the electrical and thermal characteristics of in-vivo myocardium. This selection is made for convenience and could be given the characteristics of plaque and encapsulating tissue. The characteristics can be specifically tailored for different areas of the cube or can be given average values. The cube or region or other shape selected as desired to be analyzed is subdivided into computational cells. In this simulation a cube of simulated myocardium is divided into 8000 small cubes with each cube being a computational cell. The instantaneous heat of one arbitrary computational cell in the cube is given by: Q C =Q′ C +(ΔQ RF +∫ΔQ HC )Δt where: Q is the new heat energy in the computational cell; Q′ C is the previous heat energy level; ΔQ RF is the heat added due to absorption of microwave energy; ∫ΔQ HC is the net heat added or lost by the cell from heat conduction; and Δt is a small time increment. The new temperature of the cell is given by: T C Q C /MS where T C is the new cell temperature in ° C.; M is the mass of the cell; and S is the specific heat of the cell. Each cell is assumed to be a cube with six faces. The heat energy transferred through each face for one time increment is given by: ΔQ=−KA(∂T/∂r)Δt where: ΔQ is the heat transferred through one face; K is the thermal conductivity of the cell; ∂T/∂r is the temperature gradient from the center of one cube to the next; and A is the area of one face. The electric field intensity in a cell is given by: E ^ l = E ^ nl  e - γrl r l a 10 where: Ê 1 is the electric field intensity resulting from the the radiation at the feed point of the antenna; Ê 01 is related to the relative magnitude and phase of radiation from the phase center of the antenna; and γ=α+jβ; where: α is the attenuation constant associated with the tissue; β is the phase shift constant; and r 1 is the distance from the antenna phase center to the center of a cell. a=0 for a focused beam, 1 for a spreading beam in one dimension, and 2 for a spherically spreading beam. Finally, the energy absorption at the cell is given by: W a =vδ|E| 2 Δt where: W a is the electromagnetic energy absorbed; v is the volume of the cube; and δ is the conductivity of the medium. As discussed previously, the results from the simulation can be plotted in many ways to show the size and shape of the projected isothermal volumes. FIG. 9 shows a different presentation wherein the temperature vs. time is given for each of 50 layers of 20 micron thickness with each layer being represented by a separate line. Although any of the lines could be displayed individually, only lines 1 - 4 , the top layers, and line 16 , the hottest layer are clearly visible and are marked. Each line represents a thickness of 20 microns. The heating time is one second. The frequency is 15 GHz. The volume heated is 9.4 cubic millimeters. As can be seen from this graph, layer 16 would have been heated by about 16 degrees centigrade and is about 320 microns into the arterial wall which would probably typically be in the medial layer of the artery. It will be noted that the first one or two layers that would be the endothelium would remain less than about 5 degrees centigrade, in this projection. The program may also be altered to accept the desired heat contours as the input. By working backwards from a desired thermogenic profile, the program could be used to select the most appropriate choice of frequency, power level, duration of power delivery, antenna beamwidth from a particular selection of antennas, and other factors as discussed herein. FIG. 10 discloses oscillator chip catheter 1000 as another embodiment of the present invention. In this embodiment, a direct current power supply 1010 is used to supply power through catheter 1020 to one or more MMIC chips 1030 that may use a radiating antenna 1040 such as a waveguide antenna, disk-loaded monopole antenna, or other antenna. The MMIC chips preferably reside in the catheter's distal end adjacent to the radiating element. Currently, MMIC technology allows for cylindrical diameter dimensions of about 2.76 millimeters plus a thin sheath, which an excellent size that allows for convenient positioning of catheter 1020 . The presently available chips cover the preferred range of frequencies, i.e., 2 GHz to 300 GHz, over a range from about 50 GHz to about 110 GHz. Chips operating in the lower frequencies of about 50 GHz presently offer more power per chip. To achieve greater than one watt of power delivered to radiating element 1040 , if necessary, two or more MMIC chips may be sequentially connect together. The chips may be physically connected with microstrip 1050 . Numerous variations and methods of operation may be used with the present invention. For instance, the catheter of the present invention may be used with other catheters and/or means to orient the catheter or may be built into other types of catheters. The present catheter may be modified to include simple orientation means. For instance, on the sheath side of the waveguide antenna, a simple resistivity sensor might be added that operates at a much lower frequency and with very low current but is directive and will sense the difference in resistivity of the arterial wall with or without an atheroma so as to quickly detect position and orient the device. Although the present device is preferable used instead of an angioplasty balloon, it has advantages that may also make it useful in combination with an angioplasty balloon, if desired, e.g., the ability to direct heat towards an asymmetrically positioned lesion. While the preferred embodiment antennas are disclosed in accord with the law requiring disclosure of the presently preferred embodiment of the invention, other types of antennas may also be used. Therefore, the foregoing disclosure and description of the invention are illustrative and explanatory thereof, and various changes in the method steps and also the details of the apparatus may be made within the scope of the appended claims without departing from the spirit of the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to each of U.S. Provisional Patent Applications Nos. 61/359,161, filed Jun. 28, 2010; 61/359,588, filed Jun. 29, 2010; 61/373,333, filed Aug. 13, 2010; and 61/416,892, filed Nov. 24, 2010, each of these four provisional applications being herein incorporated by reference in their entirety for all purposes. BACKGROUND OF THE INVENTION [0002] The palliative effects of certain vaporizable substances (for example, Cannabis ), have been recognized. For example, Cannabis may be utilized to ameliorate symptoms of debilitating diseases and conditions, including, but not limited to, arthritis; cancer; AIDS; Crohn's disease; chronic pain; epilepsy; glaucoma; migraine headaches; multiple sclerosis; and/or sever muscle spasms. BRIEF DESCRIPTION OF THE INVENTION [0003] In one embodiment, a method comprising: [0004] A. obtaining a purpose-built medical inhalation device; [0005] B. obtaining at least one authorized dosage form of medical Cannabis; [0006] C. inserting the authorized dosage form into the purpose-built medical inhalation device; [0007] D. unlocking use of the purpose-built medical inhalation device for a single dose cycle; [0008] E. delivering a dose of medical Cannabis to the patient utilizing the unlocked medical inhalation device in combination with the inserted dosage form; and [0009] F. recording consumption data relating to the use of the device and/or dosage form. [0010] In another embodiment, further comprising the step of verifying that a patient is authorized to use the inserted dosage form with the purpose-built medical inhalation device; [0011] In another embodiment, wherein the purpose-built medical inhalation device is for the delivery of medical Cannabis. [0012] In another embodiment, wherein the verifying step comprises identifying a patient with a prescription. [0013] In another embodiment, wherein the verifying step comprises confirming that a patient is legally qualified for use of medical Cannabis. [0014] In another embodiment, wherein the verifying step comprises confirming that a dosage form is legally qualified for use with the purpose-built medical inhalation device. [0015] In another embodiment, wherein the verifying step comprises confirming that the purpose-built medical inhalation device is authorized for use at a particular location. [0016] In another embodiment, wherein the verifying step comprises that the dosage form is authorized for use at a particular location. [0017] In another embodiment, wherein the purpose-built medical inhalation device delivers a dose of medical Cannabis without combustion. [0018] In another embodiment, wherein the verifying step comprises biometrically identifying a patient. [0019] In another embodiment, wherein the delivered dose is sanitary. [0020] In another embodiment, wherein the delivered dose is sterile. [0021] In another embodiment, further comprising the step of locking out the device when the frequency of use of the machine exceeds a given set point. [0022] In another embodiment, further comprising the step of reporting consumption data to a patient's medical services provider. [0023] In another embodiment, further comprising the step of locking out the device when the identity of the user of the machine does not match the patient authorized to use the dosage form. [0024] In another embodiment, further comprising the step of locking out the device when an inserted dosage form is not authorized for use with the purpose-built medical inhalation device. [0025] In another embodiment, further comprising the step of locking out the device when the biometric identification of a user does not match the identity of an inserted dose form. [0026] In another embodiment, wherein the dosage form is tamper-evident. [0027] In another embodiment, further comprising the step of locking out the device when the inserted dosage form has been tampered with. [0028] In another embodiment, wherein the recording step comprises recording time and location of unlocking of the device. [0029] In another embodiment, wherein the dose of medical Cannabis is delivered via a cannula. [0030] In another embodiment, wherein the delivery temperature of the dose of medical Cannabis does not exceed the heat of combustion of the dose. [0031] In another embodiment, a tamper-evident dosage form comprising a sterile, measured dose of medical Cannabis. [0032] In another embodiment, wherein the dosage form is not accessible until biometric authorization is obtained. [0033] In another embodiment, wherein the dosage form is not accessible until availability of the dose is verified. [0034] In another embodiment, a medical inhalation system for delivery of inhaled medical Cannabis to a patient, comprising: [0035] a. a medical inhalation device for the delivery of medical Cannabis; [0036] b. a tamper-evident dosage form comprising a sterile, measured dose of medical Cannabis, [0037] c. an insertion chamber designed for selective acceptance of the dosage form into the medical inhalation device; [0038] d. a control system for verifying authorized use of the dosage form in the medical inhalation device by a patient, comprised of a control system that unlocks the medical inhalation device for delivery of the dosage form upon verification of the authorized use; and [0039] e. a recording system for recording dosage form and medical device usage data. [0040] In another embodiment, wherein the control system queries a database to match the dosage form with the patient. [0041] In another embodiment, wherein the control system queries a database to match the dosage form with usage data. [0042] In another embodiment, wherein the control system queries a database to match the dosage form with a prescribed user. [0043] In another embodiment, wherein the control system queries a database to confirm that a dosage form is legally qualified for use with the purpose-built medical inhalation device. [0044] In another embodiment, wherein the control system locks out the device when the frequency of use of the machine exceeds a given set point. [0045] In another embodiment, wherein the control system reports consumption data to a patient's medical services provider. [0046] In another embodiment, wherein the control system is capable of reporting consumption data to a patient's medical services provider. [0047] In another embodiment, wherein the control system is capable of locking out the device when an inserted dosage form is not authorized for use with the purpose-built medical inhalation device. [0048] In another embodiment, wherein the control system is capable of locking out the device when the biometric identification of a user does not match the identity of an inserted dose form. [0049] In another embodiment, wherein the control system is capable of locking out the device when the biometric identification of a user does not match the identity of an inserted dose form. [0050] In another embodiment, further including a biometric identification device. [0051] In another embodiment, further including a cannula. [0052] In one embodiment, the invention is a device designed to administer medical Cannabis in consistent, single doses and with a degree of safety and control. [0053] In one embodiment, the instant invention encompasses proprietary medical dose delivery and monitoring systems that address health, safety, public safety, and law enforcement issues with respect to the emerging medical cannabis industry. [0054] In one embodiment, the device administers medical cannabis via vaporization by accommodating measured, pre-packaged doses and placing them precisely in a specially-designed vaporization chamber to enable a physician-recommended course of therapy. Doses are heated precisely to a temperature that produces therapeutically-active cannabinoid vapors (approximately 180-190° C.) but below the point of combustion (approximately 230° C.) that produces noxious byproducts, particularly carcinogenic polynuclear aromatic hydrocarbons (PAHs) which are believed to be a major cause of smoking-related cancers. In one embodiment, drug delivery is safer (without noxious byproducts of combustion); consistent (dose-to-dose); reproducible (by standardizing the mechanics of delivering a standard dose of active ingredient via vaporization stream); and easier to administer to a variety of patients with varying functionalities. [0055] In one embodiment, the device administers medical cannabis via vaporization by accommodating measured, pre-packaged doses and placing them precisely in a specially-designed vaporization chamber to enable a physician-recommended course of therapy. The vaporization chamber may optionally include some combination of baffles; intake restriction; and/or heat or dose size limitations that will prevent combustion of the medical dose on administration to the patient, without substantial variance as to combustion/substances delivered to patient as a function of the patient's lung capacity and/or strength of inhale. [0056] In another embodiment, the invention is also purpose-built to collect critical clinical and product-tracking data including time, date and number of doses administered. By recording data, the device enables analysis and control of usage by authorized parties e.g., physicians and state regulators. In one embodiment, the dose vaporization chamber accepts and positions the pre-packaged dose for optimal vaporization, and the complementary installed microprocessor/software module is configured to collect data and to interface with HIPAA-compliant data management and regulatory reporting systems. [0057] In one embodiment, the instant invention introduces distinct, commercially-valuable advantages for patients, their primary care-givers, physicians, regulators and the industry as a whole. Patients enjoy ease-of-use (particularly important for the chronically ill), a safe and healthier alternative to smoking and a precise, consistent method of administering medical cannabis for maximum therapeutic benefits. [0058] In another embodiment, the instant invention produces a mild, non-irritating and non-noxious vapor, allowing the use of inhalation, the method of administration preferred by most patients. By precisely placing the dose in the vaporization chamber, the device enables highly efficient vaporization, which allows direct, improved absorption of active ingredients (increased therapeutic efficacy) and reduces waste (saves money). In many of these respects, the instant invention dose vaporizer also has significant potential commercial value as a new device in jurisdictions that have legalized Cannabis for recreational use. [0059] In another embodiment, the instant invention permits physicians to record and control frequency, time and date of use while enabling treatment to the dose-response curve of individual patients (a critical healthcare benefit). Doctors can deliver improved care due to the patient's ability to self-administer consistent doses. Tamper-resistant packaging and digital record-keeping offer states and law enforcement authorities new tools to help ensure accountability, control and transparency throughout the medical Cannabis supply chain. [0060] In another embodiment, the instant invention delivers a product that is processed and packaged for consistency, efficacy and single-dose use. The Dose Vaporizer serves a new market category of premium-priced Cannabis products formulated for medicinal purposes with hardware, software, features and esthetics uniquely suited to non-recreational, medicinal uses. [0061] In another embodiment, the vapor is delivered into the patient's lungs via mouth or nose propelled by the patients inhalation or an automatic fan, blower, or other propulsion means. [0062] In another embodiment, the instant invention relates to allowing society a machine that cannot be utilized or reconfigured to use a medical substance in a way that is not intended and is currently illegal relieving law enforcement and society the burden of having to monitor medical marijuana with more resources. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0063] The present invention will be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the present invention. [0064] FIG. 1 depicts an embodiment of a medical dose vaporizer and cartridge. [0065] FIG. 1A depicts an embodiment of a medical dose vaporization chamber, cartridge and hot air flow restriction baffle. [0066] FIG. 2 depicts an embodiment of a medical dose vaporization chamber and cartridge. [0067] FIG. 3 depicts an embodiment of a dose cartridge, dose cartridge slot and dose vaporization chamber. [0068] FIG. 4 depicts an embodiment of a dose cartridge, dose cartridge slot and dose vaporization chamber. [0069] FIG. 5 depicts an embodiment of a medical dose vaporization cartridge. [0070] FIG. 6 depicts an embodiment of a consumer packaging. [0071] FIG. 7 depicts an embodiment of a dose cartridge assembly process. [0072] FIG. 8 depicts an embodiment of a maintenance and sterilization kit. [0073] FIG. 9 depicts an embodiment of a dose vaporizer. [0074] FIG. 10 depicts an embodiment of a dose vaporizer. [0075] FIG. 11 depicts an alternate embodiment of a dose vaporizer [0076] FIG. 12 depicts an embodiment of informatics employed by the systems, devices and/or methods described herein. [0077] While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed invention. DETAILED DESCRIPTION OF THE INVENTION [0078] Detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely illustrative of the invention that may be embodied in various forms. In addition, each of the examples given in connection with the various embodiments of the invention are intended to be illustrative, and not restrictive. Further, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components. In addition, any measurements, specifications and the like shown in the figures are intended to be illustrative, and not restrictive. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention. [0079] The term “purpose-built medical inhalation device” means: a device designed and manufactured for medical use as a method of administering therapeutic doses of Cannabis in the form of an inhaled vapor. [0080] The term “medical Cannabis ” means: a form of the plant genus Cannabis , in the form of ground plant material comprising bud, leaf, and stem materials of the Cannabis genus, or any combination thereof. [0081] The term “authorized” means: an individual or use that is approved for a medical Cannabis therapy by a recommending physician or other legally or administratively authorized provider. [0082] The term “measured” means: marked by due proportion or precise weights and measures. [0083] The term “sterile” means: treated with any of a number of recognized sterilization methods that leave the sample free from living organisms and especially microorganisms. [0084] The term “sanitary” means: free from living, esp pathogenic, microorganisms, and detrius associated therewith, for example insect parts, spores, etc. [0085] The term “sterilizable” means: capable of being rendered sterile multiple times. [0086] The term “tamper-evident” means: a form of packaging or presentation that renders improper and unauthorized use obvious to inspection (for example, visual, machine, or electronic inspection). [0087] The term “dosage form” means: a formulation that presents or administers a medicine or therapy in a single, measured, clinically-appropriate unit. [0088] The term “verifying” means: to confirm proper or authorized use or identification. [0089] The term “patient” means: an individual awaiting or under medical care and treatment. [0090] The term “unlocking” means: to open for use or access. [0091] The term “single dose cycle” means: the time and steps required to administer one dose of medicine. [0092] The term “delivering” means: to bring or transport to the proper place or recipient; to distribute or administer. [0093] The term “recording” means: the act or process of making a record; a record. [0094] The term “wherein the patient is identified with a prescription” means: pertaining to a patient who has received a prescription or recommendation from a qualified physician. [0095] The term “biometrically identified” means: the verification of identity via physical characteristics, such as fingerprints, DNA, or retinal patterns. [0096] The term “prescription” means: A written order, especially by a physician, for the preparation and administration of a medicine or other treatment; a recommendation of a medicine or other treatment from a physician. [0097] The term “without combustion” means: with no burning; the absence of fire, smoke and the byproducts of burning. With respect to medical Cannabis , “without combustion” means heating cannabis to a Cannabis material temperature of between 180 and 200 C, thereby vaporizing the cannabinoids that reside on the trichomes on the surface of cannabis flowers and leaves, while avoiding combustion (which occurs at 230 C and above) and attendant smoke toxins. [0098] The term “locking out” means: denying access; disabling a mechanism or feature; prohibiting an activity. [0099] The term “frequency of use of the machine” means: the number of times the device is used; the intensity of usage. [0100] The term “exceeds a given set point” means: anything that surpasses a predetermined limit or benchmark. [0101] The term “has been tampered with” means: has been subject to improper or unauthorized use; evidencing damage to the form of packaging or presentation. [0102] The term “the delivery temperature of the dose of medical Cannabis ” means: the temperature at which a single unit of Cannabis -based therapy is administered to a patient. [0103] The term “the dosage form is not accessible until biometric authorization is obtained” means: the single unit of therapy is not available for administration without physical verification of identity or authorization. [0104] The term “selective acceptance of the dosage form into the medical inhalation device” means: accommodating insertion of a unit of therapy only in a pre-determined manner. [0105] The term “disposable” means: designed to be replaced and discarded after use. [0106] The term “heat of combustion” means: The heat at which combustion occurs for a given substance—for example, approximately 230 C and above for medical Cannabis. [0107] The term “availability of the dose is confirmed” means that a database or other verifying means confirms that a particular purpose-built machine/person is authorized to utilize a dose. [0108] The term “one-way sanitary vapor valve” means: a valve that only allows the flow of vapor in a single direction. [0109] The term “consumption data” means data related to the location, use, frequency of use, identity of user, and identity of product used with respect to a purpose-built vaporizer/dose combination [0110] “Legally qualified for use” means that a given purpose-built vaporizer/dosage form/individual is authorized for use or using a given medical Cannabis dose. [0111] FIG. 1 depicts an embodiment of a medical Cannabis vaporizer and recording system. Removable vaporizer tube 1 is in communication with outflow vapor source 14 which receives vapor from the stabilizing chamber 15 . Vapor flow is in the direction of the arrows indicated. Exhaust temperature and data sensors 2 , 16 , measure the temperature and other physical/chemical characteristics of the vapor. This data is optionally transmitted to exhaust sensor data connections 3 , 17 . The vapor itself is generated from heated air originating from intake ports 23 , heated by a heating element 12 , and passing through a medical dose 4 of a vaporizable substance (in one embodiment, Cannabis ) held in place and surrounded by a dose suspension screen 5 itself contained within a medical dose cartridge 6 . Vapor collects in the dose vaporizing chamber 24 . Data recognition means (in one embodiment, an infrared-scannable barcode 7 ) may be located on the medical dose cartridge 6 so as to tracking and/or verifying use and user of the medical dose 4 through a dose-recognition switch 18 , and may, in one embodiment, be readable by medical dose/data connections 8 , 19 . Separate intake temperature sensor data recorders 9 and data connections 10 may also be utilized. An insulation heat sink 11 absorbs excess heat and keeps the starting temperature of the heated air utilized to generate the vapor fairly constant. An intake temperature sensor and data recorder 20 associated with an intake temperature measuring device monitors the temperature of the heated air utilized to generate the vapor. In one embodiment, the air may itself be heated by a heat element 22 and driven through the machine by an air flow fan 13 . [0112] FIG. 1A depicts an embodiment of a dose vaporizer similar to that shown in FIG. 1 , with the added differences of a hot air flow restriction baffle 13 , and air flow carburetor holes 12 . [0113] In another embodiment, the dose vaporizing chamber 6 is removable and/or separately packaged and salable, and can be attached and used with any other commercially available vaporizer and/or heat source by use of an adapter. [0114] FIG. 2 depicts an embodiment of the invention with a dose cartridge inserted. In one embodiment, the dose cartridge 8 includes a medical dose of a material between two metal screens that has not been previously vaporized or subject to other extraction or processing steps. Dose cartridge data 5 may, in one embodiment, be imprinted on the dose cartridge 8 . The dose cartridge slot 4 holds a dosage cartridge 8 so that its wire mesh section is held within the dosage cartridge vaporizing chamber 6 . Temperature regulated airflow 13 flows through the dosage, and its presence is measured utilizing a vapor temperature sensor 22 . Vapor flows in the direction of the arrows shown 23 . Vapor temperature sensor, data recording, and data connection means 2 , 3 , 20 , 21 measure vapor temperature and chemical characteristics, while—upstream of the medical dose—temperature sensor, data recording and data connection means 11 , 12 , 14 , 15 measure the temperature and/or other characteristics of the incoming air stream. The medical dose recognition switch 17 optionally allows operation of the machine only when an authorized dose/dose size is placed in the apparatus, and an optional data connection 16 allows connection to an outside computer and/or outside entity. Similar structures are provided at 9 , 10 . [0115] FIG. 3 is a side view of an embodiment of the dose cartridge, dose cartridge slot and dose vaporization chamber of the instant invention. The medical dose cartridge 1 includes a finger grip 2 for easy insertion and removal. The vaporization chamber slot 3 may be optionally designed so as only to accept a medical dose cartridge 4 of a particular configuration—thus “locking out” use of the apparatus to any potential user not utilizing a particularly configured medical dose cartridge. The cartridge is comprised of micro screens 5 , 6 which hold a dose within the dose vaporization chamber 7 . Cartridge and medical dose recognition and data connection means 9 - 10 and 12 - 13 optionally provide a mechanism to ensure that only a pre-approved, pre-measured particular dose of a medical herb or other substance is administered by matching the dose and cartridge identifying information. [0116] FIG. 4 is a top view of an embodiment of the dose cartridge, dose cartridge slot and dose vaporization chamber of the instant invention. The medical dose 1 is placed between microscreen layers 2 , 6 . The vaporization chamber slot 3 may be optionally designed so as only to accept a medical dose cartridge of a particular configuration—thus “locking out” use of the apparatus to any potential user not utilizing a particularly configured medical dose cartridge. The dose is positioned within a temperature regulated air flow 8 passing through an air flow hole 7 so as to ensure optimum efficiency in vaporization of the medical dose. [0117] FIG. 5 depicts an embodiment of the medical dose vaporization cartridge itself. The dose cartridge 1 includes a finger grip 2 and may optionally include a means for storing/transmitting product and/or cartridge specific data 3 . An optional bar code 4 provides an additional means for identification/tracking. The dose housing 5 , in one embodiment, wholly encapsulates a medical 7 dose between two screens 6 in a manner that allows for placement of a dose that is small enough to essentially prevent combustion; and thin and/or well-distributed enough to ensure consistent vaporization of relevant dose components throughout the vaporization process. A recognition switch 8 individually identifies the dose. [0118] FIG. 6 depicts an embodiment of consumer packaging utilized for the medical dose vaporization cartridges of the instant invention. In one embodiment, a plurality of cartridges are stored in a sterile airtight box. In another embodiment, the plurality of cartridges within the sterile airtight box are individually wrapped so as to ensure sterility when the box is repeatedly opened for dose access. In another embodiment, the consumer packaging is equipped with monitoring means so as, for example, to monitor the rate at which individual dose cartridges are removed from the box; the total number of cartridges removed from the box; and whether any dose cartridges removed and/or replaced within the box maintain sterility and/or are in a pre-vaporization state. In one embodiment, both the box and the individual cartridges may have individual monitoring and/or tracking means, including but not limited to computer chip, barcode and/or radiofrequency identification (RFID) tracking/monitoring/data transmission means. [0119] FIG. 7 depicts an embodiment of a Cannabis dose cartridge assembly process. In one embodiment, this assembly process is carried out by the commercial provider of the medical dose. In another embodiment, this assembly process is carried out by a licensed physician/nurse/pharmacist or other authorized third party. In one embodiment, a screen is forged 1 , so as to create a depression in the screen. The medical dose is placed 2 in the screen depression, and optionally tamped down 3 . The medical dose is then encapsulated between screens 4 . Once the dose is encapsulated between screens, the encapsulated dose may then be cut out 5 and inserted into a dose cartridge for commercial use 6 . [0120] FIG. 8 depicts an embodiment of a maintenance and sterilization kit for use with the dose vaporizer of the instant invention. A heat shield sterilization safety cap 1 may be placed over the openings of the vaporization chamber 2 to prevent contamination between uses. Means for flushing the system are also provided 4 . [0121] FIG. 9 depicts an embodiment of a dose vaporizer of the instant invention. An on/off switch 11 governs provision of power to the unit. Visual and digital data may be displayed, and a maintenance control 12 is also provided for optional control of vaporization parameters. A dose cartridge slot 4 is configured to only accept a particularly configured (physically and/or electronically or informationally) dose cartridge, and is further configured so as to place the medical dose contained within the dose cartridge in optimal contact with the heated air coming from the heat source so as to create a vapor stream. A dose location 3 is configured so as to maximize efficiency and efficacy of dose vaporization. A control data collection system 9 and USB data port(s) 8 permit recordation and/or monitoring of dose vaporizer utilization. [0122] FIG. 10 is a variant of the dose vaporizer of FIG. 9 , wherein the flexible tube 14 and mouthpiece 15 are differently configured. In one embodiment, the flexible tube and mouthpiece of FIG. 10 have an internal diameter substantially similar to that of the dose vaporization chamber. [0123] FIG. 11 depicts an alternative embodiment of a dose vaporizer. Removable vaporizer tube consists of disposable mouthpiece 1 ; disposable flexible hose 2 ; disposable expandable vapor reservoir 3 ; disposable one-way sanitary vapor valve 4 : a dose 5 housed within a cartridge vaporization chamber 6 . The cartridge may contain an RFID chip or other notification means (for example radio transmitter) and may also contain a means for detecting tampering with the cartridge 8 . A heat source 9 heats up and vaporizes the dose 5 contained within the dose cartridge 8 . Insulation 10 may optionally be used to isolate the heat source 9 from surrounding structures. An air pump 11 pushes air in the direction of the arrows indicated. Exhaust temperature and data sensors 12 measure the temperature and other physical/chemical characteristics of the vapor. The vapor itself is generated from heated air passing through a medical dose 5 of a vaporizable substance (in one embodiment, cannabis ) held in place and surrounded by a dose suspension screen itself contained within a medical dose cartridge. Data recognition means (in one embodiment, an infrared-scannable barcode) may be located on the medical dose cartridge 6 so as to tracking and/or verifying use and user of the medical dose, and may, in one embodiment, be readable by medical dose/data connections. Separate intake temperature sensor data recorders and data connections may also be utilized, as well as a processor circuit board 14 ; LED display 15 ; data display keys 16 ; USB data port 17 ; and for warm-up switch 18 . An insulation heat sink absorbs excess heat and keeps the starting temperature of the heated air utilized to generate the vapor fairly constant. In one embodiment, the air may itself be heated by a heat element and driven through the machine by an air flow fan. [0124] FIG. 12 depicts an alternative embodiment of a comprehensive medical solution comprised of purpose-built subsystems. The three subsystems may include a dose cartridge vaporizing system; a disposable safety/sterility system; and a clinical monitoring system. Physicians may gather information from a variety of sources (including the patient themselves) to determine whether the patient would benefit from a particular dosage of a product.) 1 . Subsequent to a physician determination, data related to the patient's individually identifiable information, condition, and prescribed use of a substance (in one example, Cannabis ) may be provided 2 to any of a hospital database, pharmacy database, hospice database, research database, law enforcement database, etc. Separately, dose cartridges containing a dose of a substance (in one embodiment, Cannabis ) may be produced 3 and “tagged” with any of a number of differing types of data, including identity of the dose; prescribed individual corresponding to the dose; batch and lot number of the dose; expiration date of the dose; usage of the dose; etc. Doses may be prescribed and/or distributed to a patient, and data related to machine usage; dose usage; patient usage, etc. may be stored in a database or provided in varying forms to any matter of healthcare provision, regulatory oversight, tax collection and/or law enforcement entities. 4 . [0125] In another embodiment, any portion of the instant invention—including, but not limited to, the flexible tube, dose cartridge and/or mouthpiece—may be made disposable, individually sterilizable, separable from the main apparatus of the invention and/or reusable and/or returnable. Dose Vaporizer [0126] In one embodiment, the dose vaporizer provides a mild, non-noxious, and non-irritating vapor so as to facilitate administration of medical dose (in one embodiment, cannabis ) vapors with a reduced incidence and/or risk of concomitant administration of carcinogens. [0127] In another embodiment, the dose vaporizer provides a vapor dose that utilizes substantially all of the active ingredients within a particular medical (in one example, cannabis ) sample, thus increasing efficiency of delivery of cannabis active ingredients. [0128] In another embodiment, the instant dose vaporizer permits physicians to record and control frequency, time and date of use while enabling treatment to the dose-response curve of individual patients (a critical healthcare benefit). Doctors can deliver improved care due to patient ability to self-administer consistent doses with maximum efficiency (little waste) and efficacy (greater absorption of active ingredients). Tamper-resistant packaging and digital record-keeping offer states and law enforcement authorities new tools to help ensure accountability, control and transparency throughout the medical cannabis supply chain. [0129] In another embodiment, the amount of material vaporized is not alterable by the end user. [0130] In another embodiment, the flexible tube/mouthpiece may be removed while in operation, resulting in use of the dose vaporizer in a manner that provides the vaporizer stream into a given physical space, for example, a room of a house. [0131] In another embodiment, the instant invention is designed exclusively for use by legally approved patients. [0132] In another embodiment, the instant invention is designed for home use bedside or on any or all flat table top like surfaces that are suitable for such a device and able to withstand the level of heat that may be generated by sustained use. [0133] In another the instant invention is designed for portable use, for example, as a backpack unit; a wheeled unit; a battery or liquid-fuel-powered unit. [0134] In another embodiment, the instant invention is designed to be set at the specific temperature by the factory or the legally approved provider and or doctor or caregiver that is required to vaporize Medical Cannabis or a single specific temperature that is required to vaporize any and all other medications that have been legally prescribed. [0135] In another embodiment, the instant invention is designed to be set to deliver any of a number of vaporizable medicines/alternative compounds, including but not limited to aromatherapy compounds and/or substrates. [0136] In another embodiment, the instant invention is designed to have one and only one temperature setting activatable by the user. [0137] In another embodiment, the instant invention is not designed to be used with more than one medical product. [0138] In another embodiment, the temperature, time and air velocity settings of the instant invention are not variable. [0139] In another embodiment, the instant invention is designed to have a baffle that will block the heat source and prevent the combustion of the material to be vaporized. [0140] In another embodiment, the baffle system is designed to be set at a single temperature by the factory. [0141] In another embodiment, the baffle system is designed to be activated by a time period set by the factory or controlled by the doctor. [0142] In another embodiment, the baffle system is designed to be activated by a temperature set by the factory or controlled by the doctor. [0143] In another embodiment, the heating element is designed to be activated by a time period set by the factory or controlled by the doctor. [0144] In another embodiment, the heating element is designed to be activated by a temperature set by the factory or controlled by the doctor. [0145] In another embodiment, the baffle is designed to be activated by a time or temperature set by the factory or controlled by the doctor so as to optimize heating and/or inhalation periods (for example in order to optimize extraction of the vapors from the sample) and/or for the purpose of avoiding combustion and/or control total amount of vapor/active ingredient taken in by the patient. [0146] In one embodiment, the baffle system is designed and intended to provide a vaporizing heat stream at a temperature approximately 10 degrees below the combustion point of medical cannabis. [0147] In another embodiment, the vaporizer is designed to deliver vapor to the lungs of legally approved patients via oral inhalation through a simple tube made from easily cleaned and sterilized materials such as plastic, glass, ceramics or low heat conducting metal. [0148] In another embodiment, the instant invention's vaporizer carbureting holes are designed to allow cool air to rush into the delivery tube, behind the heated vapor at the time the baffles block off the heat source. [0149] In another embodiment, the carbureting holes are designed to use cool air to push the heat created vapors deep into the patients' lungs for more effective absorption of the intended compounds of the vaporized material. [0150] In another embodiment, the carbureting holes are designed to insure that the vapors cannot reach the patients body/lungs at temperatures that would create discomfort. [0151] In another embodiment, the instant invention vaporizer is designed to only accept medical cannabis and any legally prescribed material that is packaged by a licensed provider in proprietary dose cartridges. [0152] In another embodiment, use of standardized, optimized dose cartridges may facilitate consistent dosing amounts and efficacy by minimizing human error in the preparation and use of doses prepared by the user from “loose” or unprocessed vaporizable substances. [0153] In another embodiment, the vaporizer is designed to record proper use and Illegal misuse or abuse with a data storage system. [0154] In another embodiment, the vaporizer is designed to be used by one and only one legally approved patient at a time. [0155] In another embodiment, the vaporizer is designed to be very simple to use by patients that have limiting or debilitating conditions. [0156] In another embodiment, the vaporizer is designed to be impossible to use incorrectly with automatic “lockout” cutoff if misuse, dangerous temperature levels, illegal use and any or all unintended use is detected. [0157] In one embodiment, a lockout is tied to use of a purpose-built machine in the wrong location, which may be ascertained, for example, by use of GPS geolocation. [0158] In another embodiment, a lockout is tied to use of the machine at an improper temperature. [0159] In another embodiment, a lockout is tied to use of the machine at an improper frequency of use. [0160] In another embodiment, a lockout is tied to use of the machine utilizing an improper dose. [0161] In another embodiment, a lockout is tied to use of the machine by an improper person. [0162] In another embodiment, a lockout is tied to use of the machine with an improper material. [0163] In another embodiment, the vaporizer is designed to eliminate the need for a legally approved patient to handle, come on contact with or otherwise contaminate, subdivide or transfer the material to be vaporized. [0164] In another embodiment, the vaporizer is designed to electronically alert law enforcement, care givers, insurance providers and any or all legally authorized interested parties of both proper use and illegal misuse via the Internet, Wi-Fi, blue tooth, cellular phone, land line telephone, telegraph and or other means. [0165] In another embodiment, the vaporizer is designed to fully extract the intended compounds of the material to be vaporized by proper and exact temp settings and controlling the volume of heated air that is allowed to pass through the material to be vaporized. [0166] In another embodiment, the vaporizer is designed to “present” the proprietary dose cartridge to the heat source in the optimal way to insure complete vaporization of the material. [0167] In another embodiment, the vaporizer is designed to completely vaporize each dose cartridge in a single patient use and record each used dose in a simple data collection system. [0168] In another embodiment, the vaporizer is designed to detect the identity of the legally authorized user through methods that can include fingerprint sensors, retinal scanning, proprietary passwords and electric confirmation from the recommending physician, legally authorized care giver [0169] In another embodiment, the vaporizer is designed to work only with single-use dose cartridges, and will not accept a cartridge more than once even if the sample contained within is not fully vaporized. [0170] In another embodiment, the instant invention is designed to avoid unintentional combustion through use of any or all of a smaller sample; limited temperature; limited airflow; and/or limited air intake. [0171] In another embodiment, the heat source is programmed to maintain a precise temperature below the maximum temperature. in the event of a malfunction Temp. sensors between the heat source and the dose cartridge electronically trigger a baffle that blocks heat from substance before it exceeds the minimum temp necessary for the combustion of cannabis. [0172] In another embodiment, the medical inhalation device includes a disposable vaporizer tube. [0173] In another embodiment, the medical inhalation device includes a sterilizable vaporizer tube. [0174] In another embodiment, the medical inhalation device includes a sterile vaporizer tube. [0175] In another embodiment, the medical inhalation device further includes a one-way sanitary vapor valve. Dose Vaporizer Cartridge [0176] In one embodiment, the dose vaporizer cartridge is a new device that delivers a single dose of medicine (in one embodiment, cannabis ) that has been produced for medicinal uses. [0177] In another embodiment, the dose is encapsulated between two heat-resistant screens. [0178] In another embodiment, the dose may be encapsulated between/wrapped within any available substrate, such as paper, plastic, mesh, metal, etc. [0179] In another embodiment, the two heat-resistant screens are designed so as to assist in delivering equivalent heat to the entirety of the encapsulated sample when exposed to heated air and/or convection processes. [0180] In another embodiment, the dose vaporizer cartridge is adapted and sized so as to be precisely fit into a dose vaporizer so as to provide for optimal vaporization of medical product encapsulated within the heat resistant screens. [0181] In one embodiment, the dose vaporizer cartridges are refillable. In another embodiment, the dose vaporizer cartridges are reusable. In another embodiment, the dose vaporizer cartridges are tamper-resistant, and will not work when refilled by the end user. In another embodiment, the dose vaporizer cartridges are tamper-resistant, and will work only when refilled by an authorized dispenser, who may, without limitation, be a health-care provider. [0182] In another embodiment, the dose cartridge allows physicians and/or third parties to create specific and/or customizable measured doses of medical cannabis that may be supplied within the dose cartridges. In one embodiment, such specific, controlled, measured doses of medical cannabis may include specific measured blends of multiple strains of Cannabis that are combined for the treatment of specific conditions and/or the packaging of measured amounts of a single strain of medical cannabis . In one embodiment, the dose cartridge is designed to deliver a specific amount of the chemicals in medical cannabis to the patient. [0183] In one embodiment, the dose cartridge encapsulates cannabis or any and all other substances to be delivered through vaporization between two screens, pieces of mesh or otherwise suitable material. [0184] In another embodiment, the dose cartridge is tamper evident and designed to clearly record and/or visually indicate misuse or attempted misuse. [0185] In another embodiment, the cartridge is also labeled for easy identification by Pharmacists, doctors patients and all caregivers. The cartridge is designed to be easily handled by patients and caregivers. [0186] In another embodiment, the cartridge is designed to only be used in a proprietary vaporizing delivery system. [0187] In another embodiment, the dose cartridges are designed to be compatible with and/or usable with a variety of brands and models of vaporizers that are available and/or may become available in the marketplace. [0188] In another embodiment, the cartridge is designed to be packaged in sterile easily identifiable boxes that can be distributed by pharmacies, doctors and any and all properly licensed caregivers or dispensaries whether traditional or automated. [0189] In another embodiment, the cartridge facilitates use of a medical product (in one instance, cannabis ) without requiring expensive and time-consuming pretreatment of the medical product by, for example, solubilizing, heating or otherwise transforming the medical product. [0190] In another embodiment, the dose consists of sterilized cannabis or other material, for example through use of heat, ultraviolet, or gamma-ray sterilization. Comprehensive Delivery System [0191] In one embodiment, the instant invention is designed to track and control Medical cannabis and other controlled substances or drugs that can be vaporized from their growth or production through packaging and until final consumption by the legally intended patient. [0192] In one embodiment, such tracking can be facilitated by use of any of a number of available technologies, such as RFID; Internet access; wireless access; USB device monitoring; smartphone application; internet connection; social media; etc. [0193] In another embodiment, the instant invention is designed to collect, organize, analyze and provide accurate and precise information about the use of medical cannabis by legally authorized patients to legally authorized interested parties including, without limitation, doctors, medical researchers, patient advocates, politicians, patients, insurance providers, state governments, and government agencies. [0194] In another embodiment, the instant invention is designed to detect any or all illegal use, abuse, subdivision, and unauthorized redistribution of the materials packaged in proprietary dose cartridges for use in a proprietary vaporizer. The instant invention is designed to create and utilize a single dose/single use package for medical Cannabis. [0195] In another embodiment, the instant invention is designed to record the precise time and location that a legally authorized patient ingests medical Cannabis utilizing simple data recording software and/or a GPS location device; and cross-verifying barcode/RFID using an available database or other reporting/recording methods described above. [0196] In another embodiment, the instant invention is designed to rapidly and efficiently deliver the beneficial effects of medical cannabis to legally authorized patients. [0197] In another embodiment, the instant invention is designed to completely utilize and eliminate the waste of the materials including medical cannabis that is packaged in a proprietary dose cartridge and vaporized with a proprietary vaporizer. [0198] In another embodiment, the instant invention is designed to eliminate direct contact by legally authorized patients with the material packaged in proprietary dose cartridges. [0199] In another embodiment, the instant invention is designed to track a plurality of individually-packaged doses, including tracking the identity of the person utilizing the dose; receiving the dose; purchasing the dose; ascertaining whether the dose was completely administered; and ascertaining whether the dose cartridge was tampered with and/or refilled. [0200] In another embodiment, the instant invention is usable for tracking individual acquisition and use of doses, regardless of whether the individuals are located within a healthcare facility. [0201] In another embodiment, the instant invention is capable of tracking dispensation and use of a product through its full life cycle; e.g. assessing when the relevant active ingredients have been substantially vaporized and delivered from the dose cartridge. [0202] In another embodiment, the instant invention assesses use of a dose through non-visual means. In another embodiment, such non-visible means are, for example, through use of test strips and/or chemical assays. In another embodiment, such non-visible means are indirect measurements, for example, the measurement of heat setpoint obtained and duration of heat setpoint obtained at the mouthpiece (downstream of vaporization) as a method of indirectly measuring extent of vaporization and incidence of combustion of the medical sample. [0203] While a number of embodiments of the present invention have been described, it is understood that these embodiments are illustrative only, and not restrictive, and that many modifications and/or alternative embodiments may become apparent to those of ordinary skill in the art. For example, any steps may be performed in any desired order (and any desired steps may be added and/or any desired steps may be deleted). Therefore, it will be understood that the appended claims are intended to cover all such modifications and embodiments that come within the spirit and scope of the present invention.

1a

CROSS REFERENCES TO RELATED APPLICATIONS Not Applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH Not Applicable REFERENCE TO APPENDIX Not Applicable BACKGROUND OF THE INVENTION When participating in outdoor activities such as camping or the beach, portable chairs are often used when shade from the sun is desired. Often, a separate stand is required to allow the umbrella to remain upright. It would be desirable to have an umbrella, which could be temporarily secured to a portable chair or a pair of chairs and used outside. A. Field of the Invention The present invention relates to securing a portable shade umbrella to a camping chair or a pair of camping chairs. B. Prior Art Prior art exists that relates to securing an umbrella to a portable chair. The Mungia U.S. Pat. No. 4,789,200 claims a clamp means secured to the rear surface of a chair. The present invention improves on this prior art patent because it allows the user to secure the umbrella to the legs of a chair. The Rogers U.S. Pat. No. 5,255,954 claims the use of an endless rod structure to secure an umbrella to a chair. The present invention uses a bracket system instead of an endless rod. The Booth U.S. Pat. No. 6,666,221 claims a combination chair and umbrella. The present invention is a removable device that allows a user to secure an umbrella to the legs of a chair, if desired and differs substantially for the features found in the prior art. BRIEF SUMMARY OF THE INVENTION The present invention is a removable bracket system by which an umbrella could be secured to the legs of a camping chair or pair of chairs. The present invention may be easily removed from the frame of the chair when not in use. No modifications are made to the chair as the system is mounted directly to the structure of the chair. The present device would allow the camper or person in the outdoors to mount an umbrella to the back of the portable chair or chairs without concern for the type of terrain or the condition of the terrain. Because of its exposure to the elements the device should be made from durable, non-corrosive material. Plastic is probably a suitable material. It is an object of this device to allow an individual to mount an umbrella to the back of one chair or between two chairs. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the device in use with a single camping chair. FIG. 2 is a perspective view of the device in use with a pair of camping chairs. FIG. 3 is an exploded view of the device installed on a single camping chair. FIG. 4 is a top view of the device as taken along line 4 — 4 On FIG. 1 . FIG. 5 is a front view of the device in use with a pair of camping chairs. DRAWING REFERENCE NUMERALS  5 Device 10 Compression Fitting 12 Chair peg 15 Patio umbrella 17 Umbrella pole 20 Back of chair 22 Back leg of chair 25 Back leg of chair when second chair is used 26F Flat washer 26L Lock washer 27 Wing nut 28 “U” bolt 30 “U” bolt, nut and washer assembly 32 “U” bolt, nut, washer, and clamp assembly 33 Clamp 34F Flat washer 34L Lock washer 35B Mounting plate (bottom) 35T Mounting plate (top) 36 Wing nut DETAILED DESCRIPTION OF THE EMBODIMENTS The present invention is a device 5 which allows its user to attach a beach or patio umbrella 15 to the back of a folding camping chair 20 , which has tubular frame elements. The user must first unfold the chair 20 . The user may or may not secure the bottom ends of the legs of the chair 20 to the ground through the use of chair pegs 12 . FIGS. 1 , 2 First Embodiment In the first embodiment the user secures the top mounting plate 35 T and the bottom mounting plate 35 B to a desired location on the back leg of the chair 22 . FIGS. 1 , 3 Because the plates must be able to support the weight of an umbrella 15 it should be made of sturdy material. The mounting plates are planar and of predetermined thickness and should be sturdy enough to support the weight of an umbrella. Each mounting plate is identical in shape and has a plurality, preferably six, of holes 35 H drilled through the mounting plates at desired locations. FIG. 3 , 4 The six holes 35 H are drilled in three pairs. One pair is drilled on one end, one pair is drilled in the center, and one pair is drilled on the opposite end. The position of the two outside sets of holes is determined by the specific location of the frame members of the chair. The middle set of holes is contemplated to be in the center of the respective mounting plates, 35 B and 35 T. FIGS. 1 , 3 The bottom mounting plate 35 B is aligned with the chair legs 22 below the seat of the chair. Once the desired location is determined, a “U” bolt 28 is inserted around the chair leg 22 and through the holes 35 H on either end of the bottom mounting plate 35 B. FIG. 3 , 4 The portions of the “U” bolt which protrude through the holes are equipped with threaded ends. A flat washer 26 F and a lock washer 26 L are inserted over each threaded end and a wing nut 27 is screwed loosely at first to ensure alignment onto each threaded end. Although wing nuts are discussed to secure the device, other means of attachment may be used and may include lock nuts or bolts. The “U” bolts may be either round or square. A third “U” bolt 30 is placed around the rear junction or crossed pieces of the rear center of the chair and is inserted through the center pair of holes in the bottom mounting plate 35 B. A compression fitting 10 is inserted vertically between the protruding ends of the “U” bolt 30 . FIG. 3 , 4 A clamp 33 is inserted around the protruding ends in order to firmly secure the compression fitting 10 to the bottom mounting plate 35 B. In order to secure the clamp 33 , flat washers 34 F and lock washers 34 L are slipped over the protruding ends and wing nuts 36 are screwed tightly onto the threaded protruding ends of the “U” bolt 30 . FIG. 4 Once tightened, the center assembly 32 provides stability to the user of the device 5 in the center of the device 5 . Once the mounting plates are secured to the frame of the chair and the means of securement is tightened and after the compression fittings 10 and the umbrella pole 17 is inserted through both compression fittings 10 , the entire assembly 30 provides stability for the user of the device 5 . The next step is to secure the top mounting plate 35 T to the chair; the top mounting plate 35 T is aligned with the chair legs 22 above the sitting portion of the chair. Once the desired location is determined, a “U” bolt 28 is inserted around the chair leg 22 and through the holes on the ends of the mounting plate 35 T. The portions of the “U” bolt which protrude through the holes are equipped with threaded ends. A flat washer 26 F and a lock washer 26 A are inserted over each threaded end and a wing nut 27 or other means of securement is screwed tightly onto each threaded end. FIG. 4 A third “U” bolt 30 is inserted through the center pair of holes in the top mounting plate 35 T. A compression fitting 10 is inserted vertically between the protruding ends of the “U” bolt 30 . A clamp 33 is inserted over the protruding ends in order to firmly secure the compression fitting 10 to the top mounting plate 35 T. In order to secure the clamp 33 , washers 34 F and 34 L are slipped over the protruding ends and wing nuts 36 are screwed tightly onto the threaded protruding ends of the “U” bolt 30 . FIGS. 1 , 4 With the chair 20 unfolded and tent pegs 12 securing the feet of the chair legs 22 to the ground, the umbrella pole 17 may be inserted through the compression fitting 10 on the top mounting plate 35 T and through the compression fitting 10 on the bottom mounting plate 35 B and the device secured in place. Second Embodiment The second embodiment contemplates the use of this device with two camping chairs. If using a pair of chairs, the user secures one side of the mounting plates to one chair leg 22 and the other end to the other chair leg 25 . FIG. 2 The top mounting plate 35 T and the bottom mounting plate 35 B are secured to the leg 22 of one chair and the leg 25 of another chair. The device 5 is attached using the same method as described above with the same hardware.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an improvement in a rotative toothbrush which brush the teeth vertically up and down as well as horizontally right and left. The effective way of brushing the teeth is to brush the teeth vertically up and down as well as horizontally right and left. The present invention is concerned with the improvement of a rotative toothbrush which automatically moves up and down when the user brushes the teeth horizontally right and left in a conventional way. 2. Description of the Prior Arts A toothbrush most generally used is illustrated in FIG. 8. Since a human mouth is opened horizontally, it is most convenient to brush the teeth horizontally right and left. For a long time, human beings have brushed their teeth horizontally right and left with the conventional toothbrush shown in FIG. 9. However, since such brushing of the teeth is carried out horizontally right and left, food particles and plaques existing between the teeth are not removed well. Moreover, the teeth themselves (are worn) out horizontally by the conventional brushing of the teeth and therefore, one or more grooves near the toothridges are formed by a conventional, long brushing of the teeth. Therefore, dentists advise that the user brushes the teeth vertically up and down. However, such vertical brushing of the teeth is not familiar to the common users and accordingly, the vertical brushing of teeth using the conventional toothbrush is very inconvenient. In order to solve these problems, U.S. Pat. No. 4,783,869 describes a toothbrush shown in FIG. 9. However, the toothbrush shown in the U.S. Pat. No. 4,783,869 does not rotate completely and the slight rotative movement forms an angle between the teeth and the toothbrush as described in the same U.S. Patent. Thus, effect of such brushing is insufficient and inadequate because as shown in FIG. 11, only a small portion of the brushhair of the brushhead contacts the teeth when the user uses the toothbrush. The present inventor invented a rotative toothbrush as shown in FIG. 10 which the center of a round brushead is connected with the grip by the shaft, and was filed in a Korean utility model application as No. 87-19458 (Unexamined Utility Model Publication No. 89-10102). However, as the rotative shaft is located at the center of the brushhead and as the friction (power) between the brushhairs of the brushhead and the teeth are the same in all directions, the brushhead does not rotate well. Accordingly, the effect of vertical brushing of the teeth is not, in fact, obtained. The present inventor invented the present invention as a result of an intensive study. OBJECT OF THE INVENTION One object of the present invention is to provide a novel toothbrush which can be moved vertically up and down as well as horizontally right and left when the user moves the toothbrush right and left in a conventional way. The toothbrush is composed of a round brushhead having an eccentric center, a grip and a shaft in which the end of the grip is rotatively connected with said brushhead by the shaft. Another object of the present invention is to provide a novel toothbrush which can be moved vertically up and down as well as horizontally right and left when the user moves the toothbrush right and left in a conventional way, the toothbrush composed of a round brushhead having an eccentric center in which one or more projections are formed on the back side of the brushhead along the eccentric circle thereon. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an external view of an embodiment of the toothbrush of the present invention; FIG. 2 is a rear view showing the toothbrush of FIG. 1 of the present invention; FIG. 3 is an external view of another embodiment of the present invention; FIGS. 4A and 4B illustrate the brushhead of the present invention having no projection; FIGS. 4C and 4D illustrate the brushhead of the present invention having one projection; FIGS. 4E and 4F illustrate the brushhead of the present invention having three projections; FIG. 5 is a rear view showing the ratio of eccentricity of the brushhead of the present invention; FIG. 6A is a sectional view showing an embodiment of rotative parts of the toothbrush of the present invention; FIG. 6B is a sectional view showing another embodiment of the rotative parts of the rotative toothbrush of the present invention. FIG. 7 is an explanatory view of using the toothbrush of the present invention; FIG. 8 is an external view of a conventional toothbrush; FIG. 9 is an external view of the toothbrush of U.S. Pat. No. 4,783,869; FIG. 10 is an external view of the toothbrush of Korean Utility Model Appln. No. 87-19458; and FIG. 11 is an explanatory view of suing the toothbrush of FIG. 9. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows the external form of the rotative toothbrush of the present invention. An eccentric aperture p of a round brushhead 1 is connected with the end of a grip 2 by a shaft 4. The eccentric aperture p is eccentrically and rotatively located at the center of the round brushhead 1. The rotative toothbrush is well rotative and all the brushhairs 3 of the brushhead are contacted with the teeth. As long as the ratio of the eccentricity that is, the ratio of the short radius (a): the long radius (b) of the round brushhead is large, the round brushhead will be well rotative when the user uses the rotative toothbrush of the present invention. However, it is inconvenient for the user to use the toothbrush of which the ratio of the eccentricity is large. And as long as the ratio is small, it is convenient for the user to use it. However, the rotating forces will be weak. The preferable ratio of a:b is about 2:3 to about 1:3. The brushhead 1, the grip 2, and brushhairs 3 can be made of the conventional plastic materials used in a conventional toothbrush. FIG. 6A shows an embodiment of the structure of the rotative parts of the toothbrush. The shaft 4 which has a rounded end 4' and a seal 4 is loosely set in a hole 6 formed in the end of the grip 2. The upper end 4'" of the shaft 4 is covered with a cap 7 having a hole 6' through the hole 6' and then the upper end 4'" is firmly fitted in a hole 8 of the brushhead 1. The cap 7 is sealed with the end of the grip 2 by a conventional way, e.g. by a supersonic sealing or by adhesives which are not solved in water or by heat-sealing method. FIG. 6B shows another embodiment of the rotative parts of the toothbrush. A base plate 41' of a shaft 41 is vertically molded into the upper end of the grip 2. Then, the shaft 41 is set into a housing 71 having a hole 71' and a groove 71" in a way that the shaft 41 having a projection 41" is loosely fitted into the hole 71' of the housing 71 having the groove 71". Then, the housing 71 is fixed into a hole 81 of the brushhead 1. The shaft 4 or 41 becomes freely rotative in the set state. There are other various conventional structures of the rotative parts which come under the scope of the present invention. As long as the thin shaft 4 is used, the thin shaft 4 becomes well rotative. However, it is desirable that the shaft 4 with a diameter from 0.5 mm to 2.0 mm is used. The shaft 4 can be made of metal or plastic. However, metal is more desirable than the plastic material because metal is usually more stronger than the plastic material. When the user moves the grip of the toothbrush right and left in a conventional way, the brushhead 1 is rotated by 180 degrees at its maximum owing to the difference of the friction between the brushhairs of short radius and the brushhairs of long radius contacting the teeth. Therefore, the same effect of brushing the teeth vertically up and down is obtained when the toothbrush of the present invention is used in a conventional way. FIG. 3 shows another embodiment of the rotative toothbrush of the present invention. In this case, one or more round projections 5 are formed on the back along the eccentric circle of the brushhead 1 (See FIGS. 4A and 4C. When the user uses the toothbrush having one or more round projections 5 on the back along the eccentric circle of the brushhead 1, the round projections 5 contact the inside muscle of the user's mouth and produce friction and contact a slot portion 2' of an end portion of the grip 2 and adjacent to the shaft 4 so as to effectively rotate the round brushhead 1 (FIGS. 6A and 6B); and therefore generate a kind of forces between the eccentric aperture P and the round projections 5. So, the brushhead 1 rotates more effectively and efficiently. Preferably, the round projection 5 numbers one, two, or three.

1a

CLAIM TO PRIORITY The present invention claims priority to U.S. Provisional Application No. 60/551,307, filed Mar. 8, 2004, entitled, “METHODS AND APPARATUS FOR IMPROVED CUTTING TOOLS FOR RESECTION,” and claims priority to U.S. Provisional Application No. 60/551,080, filed Mar. 8, 2004, entitled, “METHODS AND APPARATUS FOR PIVOTABLE GUIDE SURFACES FOR ARTHROPLASTY,” and claims priority to U.S. Provisional Application No. 60/551,078, filed Mar. 8, 2004, entitled, “METHODS AND APPARATUS FOR MINIMALLY INVASIVE RESECTION,” and claims priority to U.S. Provisional Application No. 60/551,096, filed Mar. 8, 2004, entitled, “METHODS AND APPARATUS FOR ENHANCED RETENTION OF PROSTHETIC IMPLANTS,” and claims priority to U.S. Provisional Application No. 60/551,631, filed Mar. 8, 2004, entitled, “METHODS AND APPARATUS FOR CONFORMABLE PROSTHETIC IMPLANTS,” and claims priority to U.S. Provisional Application No. 60/551,262, filed Mar. 8, 2004, entitled, “METHODS AND APPARATUS FOR IMPROVED DRILLING AND MILLING TOOLS FOR RESECTION,” and claims priority to U.S. Provisional Application No. 60/551,160, filed Mar. 8, 2004, entitled, “METHODS AND APPARATUS FOR IMPROVED PROFILE BASED RESECTION,” and is a continuation-in-part of U.S. patent application Ser. No. 11/036,584, filed Jan. 14, 2005, entitled, “METHODS AND APPARATUS FOR PINPLASTY BONE RESECTION,” which claims priority to U.S. Provisional Application No. 60/536,320, filed Jan. 14, 2004, and is a continuation-in-part of U.S. patent application Ser. No. 11/049,634, filed Feb. 2, 2005 now abandoned, entitled, “METHODS AND APPARATUS FOR WIREPLASTY BONE RESECTION,” which claims priority to U.S Provisional Application No. 60/540,992, filed Feb. 2, 2004, entitled, “METHODS AND APPARATUS FOR WIREPLASTY BONE RESECTION,” the entire disclosures of which are hereby fully incorporated by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention generally relates to methods and apparatus for bone resection to allow for the interconnection or attachment of various prosthetic devices with respect to the patient. More particularly, the present invention relates to methods and apparatus for improved cutting tools for resection and arthroplasty. 2. Background Art Different methods and apparatus have been developed in the past to enable a surgeon to remove bony material to create specifically shaped surfaces in or on a bone for various reasons including to allow for attachment of various devices or objects to the bone. Keeping in mind that the ultimate goal of any surgical procedure is to restore the body to normal function, it is critical that the quality and orientation of the cut, as well as the quality of fixation, and the location and orientation of objects or devices attached to the bone, is sufficient to ensure proper healing of the body, as well as appropriate mechanical function of the musculoskeletal structure. In total knee replacements, for example, a series of planar and/or curvilinear surfaces, or “resections,” are created to allow for the attachment of prosthetic or other devices to the femur, tibia and/or patella. In the case of the femur, it is common to use the central axis of the femur, the posterior and distal femoral condyles, and/or the anterior distal femoral cortex as guides to determine the location and orientation of distal femoral resections. The location and orientation of these resections are critical in that they dictate the final location and orientation of the distal femoral implant. It is commonly thought that the location and orientation of the distal femoral implant are critical factors in the success or failure of the artificial knee joint. Additionally, with any surgical procedure, time is critical, and methods and apparatus that can save operating room time, are valuable. Past efforts have not been successful in consistently and/or properly locating and orienting distal femoral resections in a quick and efficient manner. The use of oscillating sawblade based resection systems has been the standard in total knee replacement and other forms of bone resection for over 30 years. Other forms of arcuate and curvilinear sawblades and chisels have been proposed in the past as shown, for example, in U.S. Pat. Nos. 4,069,824 and 4,349,058 and PCT Publ. Appl. WO 97/05827, but these non-planar sawblade arrangement have not been widely accepted or adopted. Unfortunately, present approaches to using existing planar or non-planar saw blade instrumentation systems all possess certain limitations and liabilities. Perhaps the most critical factor in the clinical success of any bone resection for the purpose of creating an implant surface on the bone is the accuracy of the implant's placement. This can be described by the degrees of freedom associated with each implant. In the case of a total knee arthroplasty (TKA), for example, for the femoral component these include location and orientation that may be described as Varus-Valgus Alignment, Rotational Alignment, Flexion-Extension Alignment, A-P location, Distal Resection Depth Location, and Mediolateral Location. Conventional instrumentation very often relies on the placement of ⅛ or 3/16 inch diameter pin or drill placement in the anterior or distal faces of the femur for placement of cutting guides. In the case of posterior referencing systems for TKA, the distal resection cutting guide is positioned by drilling two long drill bits into the anterior cortex across the longitudinal axis of the bone. As these long drills contact the oblique surface of the femur they very often deflect, following the path of least resistance into the bone. As the alignment guides are disconnected from these cutting guides, the drill pins will “spring” to whatever position was dictated by their deflected course thus changing their designated, desired alignment to something less predictable and/or desirable. This kind of error is further compounded by the “tolerance stacking” inherent in the use of multiple alignment guides and cutting guides. Another error inherent in these systems further adding to mal-alignment is deflection of the oscillating sawblade during the cutting process. The use of an oscillating sawblade is very skill intensive as the blade will also follow the path of least resistance through the bone and deflect in a manner creating variations in the cut surfaces which further contribute to prosthesis mal-alignment as well as poor fit between the prosthesis and the resection surfaces. Despite the fact that the oscillating saw has been used in TKA and other bone resection procedures for more than 30 years, there are still reports of incidences where poor cuts result in significant gaps in the fit between the implant and the bone. Improvements in the alignment and operation of cutting tools for resecting bone surfaces are desired in order to increase the consistency and repeatability of bone resection procedures as is the improvement of prosthetic stability in attachment to bone. SUMMARY OF THE INVENTION The present invention provides for embodiments of cutting tools and soft tissue management techniques facilitating intraoperative and postoperative efficacy and ease of use. In one embodiment, the cutting tool is a side cutting tool that has only a portion of the arc of the cutting profile exposed for cutting and is preferably used in a dynamic cutting mode where the leg is moved in flexion to engage the exposed portion of the cutting profile. In another embodiment, a cutting tool having dual planar cutting profile, preferably orthogonal to each other, permits the cutting tool to be utilized to create multiple resected surfaces at different orientations without the need to disengage the cutting tool from the guide surfaces. In still another embodiment, the cutting tool is provided with an arcuate cutting blade that preferably engages a guide tool with spaced apart guide surfaces that permit the creation of resected surfaces on both the femor and the tibia for a given condyle without the need to reposition the guide or the leg. The present invention utilizes a number of embodiments of cutting tools to remove bony material to create cut surfaces for prosthetic implant attachment and fixation. The overriding objects of the embodiments are to provide the ability to perform resection in very small incisions, the creation of precise and accurate cut(s), and to provide for soft tissue protection characteristics and features preventing the tool from accidentally harming soft tissue. Specifically, many of the cutting tool embodiments disclosed are either incapable or highly resistant to damaging soft tissue, or are by means disclosed prevented from coming into contact with soft tissue in the first place. The present invention utilizes a number of embodiments of cutting guide technologies loosely or directly based on Profile Based Resection (PBR). The overriding objects of PBR technologies are to provide for significantly improved reproducibility of implant fit and alignment in a manner largely independent of the individual surgeon's manual skills, while providing for outstanding ease of use, economic, safety, and work flow performance. The present invention utilizes a number of embodiments of alignment or drill guides to precisely and accurately determine the desired cutting guide location/orientation, thus cut surface location(s)/orientation(s), thus prosthetic implant location and orientation. The overriding objects of the embodiments are to precisely and accurately dictate the aforementioned locations and orientations while optionally enabling ease of use in conjunction with manually or Computer Assisted techniques, and while optionally enabling ease of use in minimally invasive procedures where surgical exposure and trauma are minimized. The present invention utilizes a number of methods and apparatus embodiments of soft tissue management techniques and the devices supporting said techniques. The overriding object of these embodiments is to take advantage of the anatomy, physiology, and kinematics of the human body in facilitating clinical efficacy of orthopedic procedures. It is an often repeated rule of thumb for orthopedic surgeons that a “Well placed, but poorly designed implant will perform well clinically, while a poorly placed, well designed implant will perform poorly clinically.” The present invention provides a method and apparatus for reducing implant placement errors in order to create more reproducible, consistently excellent clinical results in a manner that decreases risk to soft tissue, incision or exposure size requirements, manual skill requirements, and/or visualization of cutting action. It should be clear that applications of the present invention is not limited to Total Knee Arthroplasty or the other specific applications cited herein, but are rather universally applicable to any form of surgical intervention where the resection of bone is required. These possible applications include, but are not limited to Unicondylar Knee Replacement, Hip Arthroplasty, Ankle Arthroplasty, Spinal Fusion, Osteotomy Procedures (such as High Tibial Osteotomy), ACL or PCL reconstruction, and many others. In essence, any application where an expense, accuracy, precision, soft tissue protection or preservation, minimal incision size or exposure are required or desired for a bone resection and/or prosthetic implantation is a potential application for this technology. In addition, many of the embodiments shown have unique applicability to minimally invasive surgical (MIS) procedures and/or for use in conjunction with Surgical Navigation, Image Guided Surgery, or Computer Aided Surgery systems. BRIEF DESCRIPTION OF THE DRAWINGS Other important objects and features of the invention will be apparent from the following detailed description of the invention taken in connection with the accompanying drawings in which: FIGS. 1 , 2 , and 3 are pictorial representations standard incision sizes or exposure required by the prior art, while FIG. 4 is a pictorial representation or approximation of one form of surgical exposure that is desired. FIGS. 5-11 , 29 - 31 , 45 - 49 , 58 , 88 - 98 , 104 - 130 , 131 - 146 , 154 - 168 , and 171 - 176 show various depictions of embodiments and methods in accordance with alternate embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS It should be noted that, in many of the figures, the cut surface created by the cutting tool in accordance with the techniques of the present invention are shown as having already been completed for the sake of clarity. Similarly, the bones may be shown as being transparent or translucent for the sake of clarity. The guides/pins, cutting tool, bones, and other items disclosed are may be similarly represented for the sake of clarity or brevity FIGS. 1 through 4 FIGS. 1 and 2 show conventional surgical exposures and instrumentation being utilized. FIG. 4 shows a reduced incision currently utilized in performing the current state of the art in ‘minimally invasive’ Unicondylar Knee Replacement. FIGS. 29-30 and 93 - 98 The embodiments of the present invention are shown for femoral resection. For the sake of clarity, it should be noted that any combination of the forms of the present invention disclosed herein may be modified or combined to form constructs not specifically disclosed herein, but still within the scope of the present invention. The embodiments represented in FIGS. 29 and 30 are outstanding examples of this, as one of ordinary skill in the art would clearly recognize the applicability and benefits of this embodiment for tibial and/or femoral resection in Unicondylar or Bicondylar procedures, for bone resection in ankle replacement or arthrodesis (fusion), mandibular advancement procedures, high tibial osteotomy procedures, proximal femoral and acetabular preparation in Hip Arthroplasty, and a list of other applications too long to list in detail where reproducible and safe removal of living tissue during surgical intervention is beneficial. FIGS. 93 through 98 represent an implementation of the side cutting drill embodiment of the present invention for cutting tools. It is of interest to note that the milling handle shown could further be guided by the PBR guides of the present invention to further combine the accuracy and precision benefits of PBR with the soft tissue protection characteristics of tibially embedded femoral cutting tool. It should also be noted that the side cutting drill with a curved cutting profile, similar to that shown in FIG. 119 , could also be used to attain cut geometries possessing simultaneously curved or curvilinear cutting profiles and cutting paths. In utilizing such, it would be critical that the side to side location of the cutting profile of the cutting tool be tightly controlled with respect to the desired side to side location of the implant as the side to side location of the implant would be dictated by the cut surfaces generated. Alternatively, a cutting tool with a linear cutting profile, as shown in FIG. 94 , could be utilized to create cut surfaces with a linear cutting profile and a curved cutting path, and then a second cutter with a curved cutting profile could be used to create a second, contiguous or noncontiguous, cut with a curved cutting profile and/or path whose mediolateral location was closely controlled to result in proper fit and location of the prosthesis attached to said cut surfaces. It should be noted that the cutting path of the second cutter could be located within a single plane, such as for a bilateral femoral component design, or could be curvilinearly divergent from the plane containing the cutting path of the first cut surface. This would be useful for unilateral femoral component designs (ones which require separate left and right femoral implants) so as to allow for the implant design to reflect out of plane patellofemoral kinematics and/or out of plane tibiofemoral kinematics most accurately. Interestingly, this embodiment of kinematic resection style resection could be modified to allow the cutting tool to be directly or indirectly linked to the movement of the patella with respect to the femur, or directly connected to the patella, to enable cutting of patellofemoral articular surfaces on the femur while moving the tibia and patella through ranges of motion about the tibia. The embodiments of cutting tools for use in attaining this include curvilinear end cutting mills or face cutters, side cutting drills with linear or non-linear cutting profiles, and other cutting tools capable of cutting the femur while engaged, directly or indirectly, to the patella. The side-to-side location of such cutters could be determined by engagement or adjustment with respect to a PBR or other guide, or simply by the natural kinematic path of the patella about the femur during flexion-extension of the knee joint. FIGS. 130 through 146 FIG. 130 represents a distal femur with the cuts shown for fixation to a conventional total condylar implant with the border of said cuts shown in black. FIGS. 131 through 146 show embodiments of the present invention for cutting the distal and posterior areas of the femur. FIG. 131 shows an embodiment of the present invention constituting an improved oscillating saw design. As shown, this design possesses cutting teeth not only on the leading edge as is commonly known in the art, but also on an adjacent surface allowing the saw to cut both while plunging in a direction parallel its long axis and normal to its long axis. FIGS. 132 through 134 show this in use with a cutting guide in cutting the femur. It should be noted that the two smoother areas surrounding the cutting teeth of the saw are intended for bearing contact with a guide, but that bushings, or bearings could be added to facilitate ease of use and avoidance of debris generation. FIGS. 136 through 146 show an alternative cutting means. The small cutting tool best shown in FIG. 136 is a small diameter (0.188 inches to 0.040 inches) side cutting drill, optionally for use in conjunction with a milling handle (not shown). As shown in these figures, a robustly guided cutting tool can be used to cut both condyles when guided by a guide either straddling only one condyle (as shown), or fixed to the medial side of the lateral condyle and the lateral side of the medial condyle. These embodiments may also be applied to cutting of only one condyle, and the cutting path of the guide shown modified to allow for standard or improved Unicondylar use. Also shown, the manipulation of the cutting tool while guided by a PBR guide can include plunging, sweeping and pivotally sweeping manipulations in completing the desired cuts. Once these cuts have been completed, or partially completed and finished by other means, as shown in FIGS. 145 and 146 , alternate methods may be employed to complete the remaining cuts. It should be noted that methods allowing for the resection of the posterior femoral condyles and/or the distal femoral condyles in conjunction with the proximal tibia already having been cut, provide for a phenomenal amount of laxity of the soft tissues surrounding the joint allowing for a surgeon to more easily complete cutting of the anterior cut and anterior chamfer cut. Looking at FIG. 132 , it is of special interest to note that the cutting guide surfaces may be attached to a pliers like or milling handle like positioning device which is either guided manually or by a surgical navigation system to determine the ideal location of the rails with respect to the bone. Once the rails were properly positioned, the positioning device could be actuated to cause fixation features (perhaps small spikes, or a serrated or roughened surface capable gripping the bone to which it is in contact with) to grip the bone thus robustly fixing the guide in place. It is also of interest to note that this method and apparatus may be used to position the rails along the sides of a single condyle (as generally shown in FIG. 142 ), and/or between the condyles (where the gripping surfaces would expand mediolaterally to contact the lateral surface of the medial condyle and the medial surface of the lateral condyle), and/or to the medial side of the medial condyle and the medial side of the lateral condyle (and fixed in place using additional fixation features), and/or about the medial side of the medial condyle and the lateral side of the lateral condyle. In those applications where the rails of the embodiments of the present invention were to be located under soft tissues such as the extensor mechanism, the gripping handle would benefit from the addition of the soft tissue accommodating contours disclosed in the copending provisional patent applications. FIGS. 154 through 168 FIGS. 154 to 161 show an embodiment of the present invention for performing femoral resection with an oscillating, radiofrequency, or ultrasonic driver. The cutting tool shown in FIGS. 154 and 155 is rotated about the centerline of the shaft within a limited arc of motion, similar to an oscillating saw driver, however the direction of cutting is parallel to the drive axis of the saw driver rather than normal to it as is conventionally known. In this manner, the cutting tool is capable of creating resected geometries closely mimicking natural anatomic bone shapes while enabling the resection of bone through minimal surgical exposures. As shown in comparing FIGS. 158 through 161 , instead of creating a flat posterior cut, this invention allows for the creation of cuts with a curved cutting profile. FIG. 161 represents the ability of this concept to be used to simultaneously make all tibial and femoral cuts in a single plunging motion, and that this would be attained simply by modifying the thickness of the posterior femoral cutting portion of the cutter by the amount indicated in FIG. 159 , perhaps making the difference between the radius responsible for femoral resection geometry and the radius responsible to tibial resection geometry of around 5 mm to 15 mm for a Unicondylar replacement or 5 mm to 20 mm for cortical to conventional tricompartmental replacement. It should be noted that all of the femoral cuts, and optionally the proximal tibial cut, could be made in this manner and the location and orientation of the cuts would be based off of the guide hole shown in the distal femur in FIG. 56 for making with the shaft of the cutter. Alternatively, a shaft or other guide feature could be inserted into the distal femur and the cutting tool possess a mating female feature for that shaft. This invention offers significant improvements in both minimizing soft tissue displacement and intraoperative time savings as compared to the Oxford Unicondylar Instrumentation. FIGS. 162 through 168 show an alternate but similar approach to the aforementioned. Instead of basing the control of the cutting tool on a guide feature formed or positioned on the femur, this embodiment of the present invention shows tibial resection, and alternatively both tibial and femoral resection, guided by a tibially mounted cutting guide or feature. Again, the cutting tool would be driven by a driver similar to an oscillating saw driver, although an alternative power means would be ultrasonically based to transmit ultrasonic energy along the length of the cutting tool to its curved or curvilinear cutting edge (it should be noted that in an ultrasonic embodiment, the cutting profile of the cutting tool may be other than a single arc). As shown in FIGS. 164 and 165 , this could work well with a Pinplasty style guide, or could be optionally stabilized by implementation of Cam Pin Features disclosed in copending provisional applications, and could as shown in FIGS. 167 and 168 , be used to cut both the tibia and the femur. It is of particular interest to note that what is described as the Inner cutting radius and the outer cutting radius in FIG. 163 could be ‘thickened’ as was described for the femoral mounted embodiment to allow for resection of both the tibia and a single cut on the femur in one plunging motion. Alternatively, the cutter could be extended into the femur until the cutting profile of the cutting tool became tangent to the intended cutting path of the cuts to be made and the tibia manipulated to traverse a range of motion about the femur while cutting the femur while maintaining the cutting profile of the cutting tool tangent to the cutting path of the intended resected surface. This method is very applicable to the methods and apparatus described in the copending applications referenced herein, especially, Wireplasty resection and Pinplasty resection. Alternatively, a guide like the one shown in FIG. 168 could be used to incrementally form a series of discrete femoral cuts with the femur at different positions with respect to the tibia. FIGS. 5 through 11 FIGS. 5 through 11 concentrate on alignment guide and/or drill guide techniques. FIG. 5 shows a manually operated alignment guide suitable for use with surgical exposures similar to that shown in FIG. 2 (it should be noted that surgical navigation sensors could be used to assist in determining final drill guide location and orientation). FIGS. 6 and 7 show an improvement upon the embodiment shown in FIG. 5 for enabling manual alignment guide use in less invasive incisions by providing soft tissue accommodating contours or reliefs. In other words, for a medial parapatellar incision, the alignment guide is configured to allow for appropriate contact and referencing of the distal and posterior femoral condyles, the IM canal (when not relying on an extramedullary reference or inference of the mechanical axis) or IM Rod, the anterior cortex or anterior runout point of a given or proposed implant size (via a stylus not shown), and the epicondylar axis via palpitation or visual reference while the patellar tendon, patella, and/or quadriceps tendon is draped over the lateral side (right side as shown in the figures) of the alignment guide allowing insertion of the guide when the patella is neither everted not fully dislocated as in conventional techniques. It should be noted that initial alignment indicated by reference of the distal femur may be further adjusted in all six degrees of freedom as a fine tuning for final cut location and orientation. This simply calls for the inclusion of additional adjustment of the location and orientation of the crossbar mechanism and/or rotational alignment arm, with respect to the initial reference provide for by contact between the body of the guide and the bone (optionally including the IM Rod), in flexion-extension angulation, varus-valgus angulation (rotational angulation and Anterior-Posterior location are already shown), mediolateral location (represented in this embodiment of the current invention by the cross bar mechanism in FIG. 5 where drill guide mediolateral location is shown as being independently and infinitely adjustable), and proximal-distal location (as shown in FIGS. 5 , 6 , and 7 —it should be noted that this adjustment might be best embodied in an infinitely adjustable slide as opposed to the incrementally adjustable slide shown, and that simple marking would be present indicating the relative movement of the slide with respect to the body). It may be desirable to only utilize only a medial drill guide plate with multiple drill guide bushings to create holes extending partially or completely across the femur depending upon the manner in which the guides are to be connected to the femur. FIGS. 8 , 9 , and 10 show an alternative alignment/drill guide embodiment of the present invention wherein a cannulated surgically navigated handle/drill guide is used to create fixation apertures in the bone for direct or indirect fixation of a cutting guide. As shown in FIG. 8 , it may be advantageous to include tines for penetrating the bone to obtain initial stabilization of the handle in the location and orientation indicated by the surgical navigation system (“Surg Nav”—this term shall be used interchangeably with Computer Aided Surgical System or Image Guided Surgical System throughout this disclosure) prior to extending the drill, represented in FIG. 10 , into the bone to create the aperture. An alternate feature to the tines shown could be a smooth but thin walled cylindrical edge of sufficient thinness or sharpness allowing it to cut and penetrate the bone to achieve initial stabilization prior to drilling. It should be noted that the aperture, or hole, thus created could be blind or extended to a specific depth, or optionally extended entirely through the bone and out the furthest side of the bone. Importantly, this process could be utilized transcutaneously through a small stab wound (perhaps 4 mm in length) through the skin to the bone surface, or through a preformed incision through which other instrumentation of the present invention or other devices including the prosthetic implant may be introduced during a procedure. Further, although only one cannulation is shown, a single handle may desirably contain multiple cannulations, some or all of which could be adjustably extended into contact with the bone to reduce any wandering of the drill contacting oblique bone surfaces and improve the precision and accuracy of aperture creation (thus allowing for the creation of apertures in the medial side of the femur, represented in FIG. 11 , with a single Surg Nav Handle—Also, the apertures of the drill guide may be configured such that the femoral and tibial apertures shown in FIG. 11 are all created using a single positioning step for the handle). As represented in FIG. 9 , there is very little distance over which the drill is cantilevered between its guidance within the cannulation(s) and its point of initial contact with the outer surface of the bone. This aspect of this embodiment of the current invention is critical in preserving the potential accuracy of Surg Nav systems, ie; the navigation system (the computer and the sensors) may be capable of determining appropriate location and orientation to +/−0.5 mm and +/−0.5 degrees, but if the location and/orientation of the aperture created represents some path of least resistance in bone which is followed by the drill, the resultant location and orientation of cut surfaces, and thereby the location and orientation of the prosthesis attached thereto, will likely be seriously in error. At the end of the day, if the aperture creation step is not carefully controlled, you will have a very expensive alignment system whose stated purpose is to increase reproducibility, and whose method of implementation compromises this stated purpose. It should also be noted that the methods described herein are applicable to the methods demonstrated in Provisional Patent Application Ser. No. 60/536,320 “Methods and Apparatus for Pinplasty Bone Resection”, and Provisional Patent Application Ser. No. 60/540,992, entitled “Methods and Apparatus for Wireplasty Bone Resection.” It should also be noted that another embodiment of the present invention, represented in FIGS. 88-92 , benefits from the apparatus and principles of operation outlined above. As shown in FIG. 88 , an aperture and a plane are created in bone which actually act as the cutting guide in controlling the location and orientation of the cutting tool within a specific plane during the creation of a cut surface. In this embodiment of the present invention, the cannulated drill guide will, in either manual or Surg Nav techniques, be used to guide a forstner style drill bit (the ‘guide surface’ shown in FIG. 88 could have been created by a modified drill with a leading section 15 mm long by 4 mm in diameter, responsible for the pivot aperture, and a 10 mm diameter following section which was about 10 mm long, responsible for the pivot reference surface) to create a larger diameter cylindrical aperture the bottom of which would define a pivot reference surface parallel to the cut surface to be created, and a smaller diameter cylindrical aperture to form a pivot aperture for maintaining the body of the bushing shown in FIGS. 88-91 in the proper location and orientation while cutting. Importantly, the technique outlined above is beneficially applied to tibial resection or any other planar or curvilinear resection technique as well. FIGS. 104 through 106 are an embodiment of the present invention that may prove to be a very usefully alternative to conventional rectilinear based referencing techniques. In essence, conventional alignment techniques, once having established appropriate flexion extension angulation and varus valgus angulation of desired implant location, reference the anterior cortex, distal most femoral condylar surface, and posterior most condylar surface (indicated in FIG. 105 by stars) to dictate the anterior posterior location, proximal distal location (otherwise known as distal resection depth), and appropriate implant size in determining the ‘perfect’ location and orientation for the appropriately sized implant (mediolateral location is normally ‘eyeballed’ by comparison of some visual reference of the mediolateral border surrounding the distal cut surface and some form of visual guide reference). These conventional techniques fail to directly reference the distinctly different anatomic bone features which dictate the performance of distinctly separate, but functionally interrelated, kinematic phenomena, and they also attempt to reference curvilinear articular surfaces by way of rectilinear approximations. The embodiment of the present invention is an alternative alignment technique with an object to overcome the errors inherent in prior art. As shown in FIG. 106 , the femur possesses two distinct kinematic features and functions that lend themselves to physical referencing; the patellofemoral articular surface and the tibiofemoral articular surfaces, both of which are curved, more specifically these surfaces represent logarithmic curves that may be effectively approximated by arcs. The one codependency between the two articular functions, and therefore any geometric approximation made of them in referencing, is that they must allow for smooth kinematically appropriate articulation of the patella as it passes from its articulation with the trochlear groove (shown in blue in FIG. 106 ) to its articulation with intercondylar surfaces between the femoral condyles (shown in red in FIG. 106 ). Thus, knowing that three points define an arc and may be used to approximate a curve or sections of a curve, what is proposed is to use a referencing device which contacts at least one femoral condyle at three points to determine both an approximation of arc radius and centerpoint location, while independently or simultaneously referencing the trochlear groove at three points to determine both an approximation of arc radius and centerpoint location. The referencing system would further need to provide for the need of the articular surfaces of the trochlear articular surfaces to smoothly transition to those of the intercondylar surfaces. Armed with this information, a surgeon may most appropriately determine appropriate implant location and orientation. This embodiment of the present invention is especially useful in determining the proper location, orientation, and implant size for modular tricompartment components, non-modular implants, and standard implants where the appropriate size, location, and orientation would be determined by that which best mimics existing articular bone surfaces thus resulting in optimal postoperative kinematic function. Alternatively, surgical navigation methods could be implemented in registering these articular surfaces and determining the resulting idealized implant location(s) and orientation(s) as reflected by the geometry and/or kinematics of the joint. The following patents and patent applications describing various surgical navigation system and alignment and cutting guide systems that are beneficially utilized in whole or in part with the embodiments of the present invention are herein incorporated by reference: U.S. Pat. Nos. 2004/0122436, 2003/0069591, 2004/0039396, 2004/0153083, 5,810,827, 6,595,997, 2003/0069585, 2003/0028196, JP74214-2002, U.S. Pat. Nos. 2003/0208122, 6,725,080, 2004/0122305, 6,685,711, 2004/0153085, 2004/0152970, 6,694,168, WO04100758, WO04070580, WO04069036, U.S. Pat. Nos. 5,799,055, 6,236,875, 6,285,902, 6,340,363, 6,348,058, 6,430,434, 6,470,207, 6,477,400, 6,491,699, 6,697,664, 6,701,174, 6,711,432, 6,725,080, 6,796,988, and 6,827,723. Image guidance techniques typically involve acquiring preoperative images of the relevant anatomical structures and generating a data base which represents a three dimensional model of the anatomical structures. The relevant surgical instruments typically have a known and fixed geometry which is also defined preoperatively. During the surgical procedure, the position of the instrument being used is registered with the anatomical coordinate system and a graphical display showing the relative positions of the tool and anatomical structure may be computed in real time and displayed for the surgeon to assist the surgeon in properly positioning and manipulating the surgical instrument with respect to the relevant anatomical structure. As is known in the art, the relevant dimensional data concerning an anatomical structure of interest, e.g., a femur, may be determined using data acquired from images of the anatomical structure to generate a data base representing a model of the anatomical structure. The model of the anatomical structure may be a three dimensional model which is developed by acquiring a series of two dimensional images of the anatomical structure. Alternatively, the model of the anatomical structure may be a set of two dimensional images having known spatial relationships or other data structure which can be used to convey information concerning the three dimensional form of the anatomical structure. The model of the anatomical structure may then be used to generate displays of the anatomical structure from various perspectives for preoperative planning purposes and intraoperative navigational purposes. A variety of technologies which may be employed to generate such a model of an anatomical structure are well known in the art and include computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), ultrasound scanning and fluoroscopic imaging technologies. In one embodiment, the present invention contemplates a computer-based method of generating a surgical plan comprising reading digital data associated with a 3D (three-dimensional) model of a patient's bone, wherein the digital data resides in a memory in a computer; and generating a surgical plan for the patient's bone based on an analysis of the digital data associated with the 3D model. A surgical planner/simulator module in the computer assisted orthopedic surgery planner software makes a detailed surgical plan using realistic 3D computer graphics and animation. The simulated surgical plan may be viewed on a display seen of a personal computer. The planner module may also generate a pre-surgery report documenting various aspects of the bone surgery FIGS. 45 through 49 concentrate on mediolaterally, or ‘side to side’ oriented pins. Although any kind of cutting tool or milling handle could be engaged to these pins, a sagittal saw and an oscillating saw are shown. A wire or gigli saw could also be used in conjunction with the pins or guides disclosed herein as the cutting profile of such a saw affects the same linear cutting profile as a planar saw blade. Similarly, any of the following cutting tools effecting a linear cutting profile could also be used: rotating or oscillating or reciprocating cutters, linear milling tools, garrotes (thin, highly tensioned wire cutter), powered rasps or broaches, manual rasps or broaches, jack hammers, chisels, chain saws, osteotomes, abrasive wire cutters, oscillating/reciprocating/chain/gigli/coping/scroll/band/circular/hack/jig/sagittal saws, belt cutters, or cutting tools that combine elements of the aforementioned cutting tools. In one embodiment, cutting tools may be plunged across, along, or through the pin guides of the present invention in any direction desirable. The directions of tool movement with respect to the pins include those generally oblique, normal, or parallel to the long axis of any pin, guide, or guide surface of this invention. Furthermore, the cutting tools may move linearly with respect to the bone and/or guide, or may be manipulated to move in circular, nonlinear, or ‘sweeping motions. Furthermore, although the pins can have the upper surface of the guide pins having been used to guide the cutting tool to create the cut surface, the pins could easily be located in a more anterior location allowing their ‘underside’ to act as the guide surface. This concept could be referred to as ‘undercutting.’ The technique of cutting while engaged to the ‘upper side’ of the pins could be referred to as ‘overcutting’ (a term not to be confused with removing too much bone). FIGS. 45 through 49 show an alternative or adjunct/modular guide for use with the pins. This modular guide could be integrally formed with the pins or seperably attached thereto. The modular guide surfaces could help the surgeon initially align the cutting tool with respect to the pins and/or the cut to be created and/or/also to maintain that relationship during a portion of or the entirety of the cutting process used to create the cut. Undercutting is also beneficial in this form of the present invention, as is the split pin, hollow pin, and hollow split pin embodiments of the present invention. FIG. 58 shows that a cutting tool (in the instance shown, an oscillating saw blade) could be located, oriented, and/or moved/manipulated along, across, and/or through the pins/guides of the present invention in any manner desired. FIGS. 108 and 109 show the distal femur having been prepared to receive the cutting guide forms of the present invention that could be used to complete the remainder of the cuts. Beneficially, a single guide could be used to complete all the cuts by being incrementally attached to the bone at the appropriate locations as shown in FIGS. 107 , 110 through 118 , 120 and 121 . Alternatively, a modified ‘ 4 in 1 ’ cutting block designed to engage the pins of the present invention could be used. The modified ‘ 4 in 1 ’ block could further be modified by being vertically cut in half and having the pins extending laterally of the block to provide guidance of the cutting tool laterally beyond the location of the conventional guide surfaces. FIGS. 114 through 121 show a capture feature added to the guides previously shown in FIG. 113 . Note that FIG. 120 demonstrates that despite the abbreviation of the laterally located guide surfaces (to facilitate medial incision based procedure), the cutting tool remains robustly guided by the guide of the present invention when both the medial and lateral side of a bone is cut. Note that this design is shown to facilitate a medial approach and thus the guide has been ‘medialized’ to minimize necessary incision size--if a lateral approach were implemented, a ‘lateralized’ form of the present invention could be made available. FIGS. 122 through 127 show some of the combinations of the forms of the present invention in use to complete the posterior cut. As shown in FIGS. 122 , 125 , and 127 , two pins are located in overcutting mode, while two other pins are shown in undercutting mode. The combination of these pins acts to constrain motion of the cutting tool from traveling beyond the plane to be cut. For the sake of clarity, any combination of the forms of the present invention disclosed herein may be modified or combined to form constructs not specifically disclosed herein, but still within the scope of the present invention. Tibial resection in TKA can be somewhat frustrating to a certain percentage of orthopedic surgeons. This frustration appears to stem from the high demands upon the surgeon's manual skills or craftsmanship. The forms of the present invention may help alleviate this issue by providing positive guidance of the cutting tool throughout all or most of the cutting process. Also, it should be noted that these concepts allow for implementation with very small incisions. FIGS. 128 through 130 forms of overcutting type pins/guides. Cutting tool captures are not shown, but could be seperably attached or formed integrally with the guide or pins. It is important to note the extent to which this and other forms of the present invention allow for contact with and guidance of the cutting tool. This creates a very stable surface for guiding the cutting tool. It should be noted that undercutting forms of the present invention could be used with guides or pins of similar configurations. Preferably, pin guide members are made of materials that are more durable than bone material and also at least as durable, if not more durable, than the materials of the planar saw blade of the cutting tool. Materials could be harder or softer than the material comprising the cutting tool, and in some cases the cutting tool and the pins could be the same material--this is especially viable for ceramics which have very nice bearing characteristics. Certain surface treatments for metal may also be advantageous (titanium nitride, ceramic or non-metallic coating). Preferably, the cutting tool is prevented from cutting or abrading the cutting guide to avoid debris generation. Although pulsating lavage will normally clean any debris from the cut surfaces, the possibility of a foreign body, allergic, or other adverse reaction should be avoided. In certain situations, however, it may be desirable to construct the pin member guides of allograft or autograft bone tissue, such as when used in cortical bone tissue where it may be acceptable to cut the pin member guides. Diamond, or other carbon-based materials, could also be utilized, cost permitting. Also, the pin guides could be constructed of plastics, liquid metal, or some other form of injection moldable material thereby reducing cost levels to an extent enabling the pins to be offered on a disposable or semi-disposable basis. FIGS. 172-176 show various depictions of the placement of pin members and operation of a cutting tool in accordance with alternate embodiments of the present invention. FIGS. 172 and 173 show yet another embodiment of the cutting guides of the present invention. This embodiment could be described as a hollow, divergent, split pin configuration cutting guide. In this embodiment of the present invention, the divergent angle of the pin axes are set to approximately 20 degrees, but divergent angles of up to 130 degrees are considered to be within the scope of the present invention as are pins that coact to form axes that intersect within the border of the resected surface(s) to be created as viewed from a direction normal to the resected surface to be created. One feature of critical benefit to MIS procedures with respect to this embodiment of the present invention is the ability of the split pin to incorporate a stop feature (as shown in FIG. 172 ) where critical structures such as ligaments, tendons, capsule, veins, arteries, or nerves may be prevented from direct contact with the cutting tool's cutting surfaces by limiting the depth to which the cutting tool may be extended in the direction of those critical structures prior to contacting the stop feature. Another important feature of this embodiment of the present invention is the flexibility of the divergent guide that enables the cutting guide to be squeezed by the surgeon to initially line up and insert the tips of the pin features into the divergent apertures and then push the pins into the location desired. It should also be noted that the two divergent pins could be constructed as independent constructs as opposed to the unitary structure shown in FIG. 172 and optionally provide features for attachment of a bridging feature. FIGS. 174 , 175 , and 176 show an embodiment of the present invention that in essence provides for the apertures formed in the bone to act as the cutting guide in coacting with a carriage linked to a saw blade or other cutting tool. Beneficially, the saw blade and carriage (hereinafter referred to as the “cutting tool/pin guide”) may be packaged together as an assembly intended for single use only, or a limited number of uses, and/or as sterile or non-sterile. In essence, the retention feature of the cutting tool/pin guide enables the cutting tool and carriage components to coact to continuous guide the cutting tool as it traverses the surfaces within, along, and about the apertures formed in the bone to create the resected surfaces with respect to which the implant is to be fixed. This embodiment also possesses an effective stop feature preventing the cutting teeth from inducing catastrophic damage to soft tissue structures. FIG. 171 describes another embodiment of the present invention. The device overcomes the drawbacks of the inability to easily and accurately secure existing alignment or guide systems to a desired location or position, a problem often referred to as the fiddle factor problem. The fiddle factor problem extends intraoperative time, creates surgeon frustration and can lead to implant mal-alignment due to inaccurate alignment guide or cutting guide positionings. An example of the fiddle factor problem in existing alignment and guide systems is shown, for example, in the device by Grimm described in U.S. Patent Publ. No. 2004/0122436 (herein incorporated by reference). The actuation of the locking mechanism to fix the carriage with respect to the sphere will actually cause the carriage to rotate with respect to sphere. Thus in use, the surgeon would attain the correct location and orientation of the cutting tool guide of Grimm, as indicated on the computer display, and then attempt to lock varus valgus, flexion extension, and internal/external rotational alignment by way of the actuation of locking mechanism, but in doing so, the carriage, and thereby the cutting tool guide would shift from the desired orientation. This dynamic will force the surgeon to iteratively tighten the lock, adjust the carriage, tighten the lock a little more, adjust the carriage a little more, tighten the lock even more, adjust the carriage a little more, etc., until intraoperative time constraints would compel the surgeon to move forward with the procedure with alignment that is suboptimal. These problems can be compounded by several additional adjustments and locking mechanisms to similarly fiddle that need to be made prior to making the first cut. Simply put, the major problem with the majority of surgically navigated “anchor-cutting guide linkage” type devices is that the act of locking the orientation and location of the cutting guide in place with respect to the anchor and/or the desired implant location and orientation actually causes the location and orientation of the cutting guides to change, in some cases radically. As the ultimate objectives of surgical navigation are to improve accuracy and promote and facilitate minimally invasive implantation, the fiddle factor problem clearly runs counter to these objectives. This embodiment of the present invention solves the fiddle factor problem by providing for an elegant locking mechanism that secures a plurality of translation and rotational degrees of freedom in a manner which fails to shift the location and orientation of the cutting tool guide while it is being secured. More precisely, the sum of the force moment couples acting about the center of mass of the cutting tool guide(s) by the actuation of the locking mechanism are governed by the following equation: .SIGMA.M.sub.(x,y,z)+.SIGMA.F.sub.(x,y,z)=0 (1), where M=moments about three mutually orthogonal axes and F=forces about three mutually orthogonal axes. The primary components of this embodiment of the present invention are shown in FIG. 171 . These include the anchor, the locking sleeve, the split sphere, the cutting tool guide and the Surgical Navigation Sensor (not shown for the sake of clarity and will herein be referred to simply as a “sensor”). The anchor possesses four primary features, either alone or in combination with the primary components of this embodiment of the present invention. Those features include a bone penetrating and anchor stabilizing feature (indicated as the anchor thread in FIG. 171 and the drill tip in FIG. 171 ), a locking feature (indicated as the conical lock in FIG. 171 ), a linkage engagement feature (indicated as the locking channel in FIG. 171 ), and a quick release feature (indicated as the release tabs in FIG. 171 ). In use, the anchor may be drilled into and fixed to a face of the bone in one continuous or semi-continuous step, or an aperture may be predrilled to which the anchor is subsequently fixed. If pre-drilling is used, a simple template (not shown) including a faux guide surface, drill guide aperture, and handle may be used for the purpose of facilitating the surgeon's “eyeball” placement of the pre-drilled aperture; in other words, the faux guide surface acts as a general indication of where the surgeon thinks the cut is to be located simply based on how it looks relative to the bone based on the surgeon's judgment/experience to facilitate pre-drilled aperture placement for the anchor enabling minimal adjustment of the cutting tool guide with respect to the anchor. The locking sleeve possesses three primary features alone or in combination with the primary components of the embodiment of the present invention including a drag feature, a locking feature, and a surgeon grasping surface. These features coact to enable rapid and effective locking and quick release of the cutting tool guide with respect to the anchor. The drag feature coacts with the anchor, split sphere, and cutting tool guide to affect frictionally resisted movement of the cutting tool guide with respect to the anchor about 3, 4, 5, 6, 7, or 8 degrees of freedom. The split sphere, in this embodiment of the invention, possesses three primary features alone or in combination with the primary components of the embodiment of the present invention including an articulation aperture feature, a spherical articulation feature, and a relief feature. As may be seen in FIG. 171 , the articulation aperture feature of the split sphere coacts with the articular post of the cutting tool guide to enable frictionally resisted movement and frictionally affected locking of the cutting guide with respect to the split sphere. When enabling frictionally resisted movement (herein described as “drag mode”), the amount of force against which this mechanism must resist movement of the cutting tool guide with respect to the anchor is at least equivalent to the force affected by way of gravity, and in preferred embodiments, is at least equivalent to the combination of force affected by gravity and the force affected by soft tissue contacting the device. When enabling frictionally affected locking (herein described as “locking mode”), the amount of force against which this mechanism must resist movement of the cutting tool guide with respect to the anchor, in a preferred embodiment, is at least equivalent to the force moment couples the applied to the device by the combination of gravitational, soft tissue, and cutting tool contacting forces. To further facilitate the effectiveness of these modes, the internal and external surfaces of the split sphere, and optionally the features of the present invention that come into contact with them, are textured to facilitate robust fixation. Such textures include, but are in no way limited to, #7 to #20 grit blast, Tecotex.TM., knurling, and other means known in the art for effectively increasing the surface area of a smooth surface. The spherical articulation feature of the split sphere enables both tri-axial rotational and single axial translational manipulation of the split sphere with respect to the anchor and along its long axis, as well as simultaneous locking of those degrees of freedom, and an additional axial translational degree of freedom of the articulation post of the cutting tool guide with respect to the articulation aperture feature of the split sphere. Locking is attained by compression of the locking channel feature (see FIG. 171 ) of the anchor against the spherical articulation feature and, by way of the relief feature of the split sphere, the articulation post feature of the cutting tool guide. The relief feature of the split sphere enables two distinct functions. The relief feature enables elastic compression of the split sphere against the articulation post of the cutting tool in response to force applied to the split sphere by the locking channel feature in response to actuation of the conical lock feature. In the context of tibial resection for the embodiment of the present invention, the sphere articulates with respect to the anchor in 4 degrees of freedom (anterior to posterior, varus-valgus, internal external rotation, and flexion-extension) while the articulation post, and thereby the cutting tool guide, articulate with respect to the split sphere, and thereby the anchor and bone, in at least one additional degree of freedom (proximal-distal). The second function of the relief feature is to optionally allow the articulation post of the cutting tool guide to be rotationally keyed to the split sphere to enable the split sphere and cutting tool guide to be rotated in tandem with respect to the locking channel of the anchor. In another embodiment of the present invention (not shown), the articulation post of the cutting tool guide could be split along its long axis and coact with an articulation feature on the cutting tool guide to enable mediolateral translation and locking of the cutting tool guide with respect to the bone wherein effective locking of the mediolateral degree of freedom would also be affected by actuation of the cone lock feature in addition to the aforementioned 5 degrees of freedom. The complete disclosures of the patents, patent applications and publications cited herein are incorporated by reference in their entirety as if each were individually incorporated. Various modifications and alterations to this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention. It should be understood that this invention is not intended to be unduly limited by the illustrative embodiments and examples set forth herein and that such examples and embodiments are presented by way of example only with the scope of the invention intended to be limited only by the claims set forth herein.

1a

The present application is a continuation in part of the applicant's prior co-pending application filed Feb. 1, 1999 as Ser. No. 09/243,353 now U.S. Pat. No. 6,299,533 which in turn was a continuation in part of an application filed Oct. 30, 1997 as Ser. No. 08/961,357 now U.S. Pat. No. 5,876,283. The present invention relates to supplemental casino games, and in particular to an additional non-progressive reward which can be employed with any of a number of games played in a casino. BACKGROUND OF THE INVENTION Casinos have a number of games which appeal to a person's temptation to take a risk, with the hope and expectation that the risk taken at the right time and under the right circumstances will result in a return which far exceeds the investment. A typical casino provides many games to a prospective customer including blackjack, poker, baccarat, roulette, craps and slots. Recently, progressive games have been introduced into casino play. The progressive game includes a jackpot and participants who wish to wager on the progressive game contributing a fixed wagering amount by token or cash into a jackpot, and if the participant does not win, a portion of his contribution is added to the jackpot. Accordingly the jackpot becomes progressively larger with each unsuccessful bet until a winner is determined. Jones, U.S. Pat. No. 4,861,041 taught a method whereby a progressive game could be offered as a side bet to a game of poker. In our prior U.S. Pat. No. 5,573,248 we taught a method whereby a progressive game could be offered as a side bet to a game of craps. In our prior U.S. Pat. No. 5,876,285 we also taught a method whereby a progressive game could be offered as a side bet to a game of baccarat. Casinos have found that progressive games facilitate in the attraction of players into games, the retention of players who have already engaged in a game, and on the whole, increase table or slot profitability. Casinos are, therefore, seeking to incorporate a supplemental game with each type of game played within the casino. There are however certain draw backs to incorporating a progressive game into the play at the tables of a casino. First, such games require the programming of a computer to receive impute from all the participating tables and the modification of the gaming tables to receive the associated hardware. Once installed a progressive game will attract participation from players after a sizeable jackpot has been built up, but it will draw little interest for a lengthy period of time during which the jackpot is small following a “win.” Also, the mechanical equipment needed to operate existing progressive games are subject to declaring a false winner or may overlook a legitimate winner. It would be desirable therefore to provide a supplemental reward to the players of a gaming table which would attract participation by players immediately after a “win,” which would not be subject to declaring a false winner or overlooking a true winner, and would not require the modification of gaming tables to receive necessary hardware. It would also be desirable to provide a non-progressive reward which would interact with a number of different games in the casino. It would also be desirable to have a reward whereby a player at a black jack table could participate and win a portion of a reward jackpot in the event of the occurrence of a given winning combination in a poker hand at a distant table in the casino. SUMMARY OF THE INVENTION Briefly, the present invention is embodied in a universal non-progressive additional reward wherein a player at a casino is provided the opportunity to wager an additional bet to win the additional reward where there are several types of games with each type game played on a plurality of tables. In accordance with the invention, each gaming table has a playing surface suitable for use by the game for which the playing surface is intended, and all the game tables participating in the universal non-progressive reward have the same predetermined number of play stations, or a multiple of the predetermined number with each play station suitable for use by one player. Each play station also has an identification number or symbol which is one of a set of identification numbers equal in number to the predetermined number, with each number in the set occurring the same number of times at each table. The game includes an additional reward token or other negotiable item purchasable by a player in advance of play at one of the play tables, the token to be displayed on the play surface at the commencement of the play of a game at a table to designate that the player is wagering in the game for the additional reward. Each type of casino game has a set of winning conditions under which a player positioned at a given play station is entitled to win a portion of the additional reward. A player at play station number 4 of a blackjack table, for example, would win a portion of the additional reward if he deposits an additional reward token on the table before the commencement of a hand and he was dealt a pair of fours, and the dealer was likewise dealt a pair of fours on both of their first two cards. The set of conditions under which a player at a numbered play station of a blackjack table, therefore, has a winning combination if the cards dealt to both the dealer and the player are identical to the number of his play station. For roulette, a player at a play station bearing a given number who deposits an additional reward token on the table to participate in the game would win if the player bets on a number associated with his play station, the ball comes to rest in the hole for that number, and the rotating portion of the wheel stops with the ball against a section of the surrounding race which bears the same number as the player's play position. A player at a play station of a poker table who has deposited an additional reward token on the table has a winning combination when the dealer has a completed hand of four of a kind and the four cards correspond to the number of his play position. A player at a slot machine would win if he deposits the maximum number of coins in the machine, including one for the additional reward, and the top award combination occurs on the reels after the handle has been pulled, and the top award includes a number corresponding to the number of the player's play station. In accordance with one embodiment of the invention there is but one winner of an additional reward for each play. In accordance with an alternate embodiment of the invention, when the selected set of conditions for winning a reward occurs for a first player at a first play station having a given first number, a portion of the jackpot is paid to a second player positioned at a second play station for which an additional reward token has been deposited on the table and the number for the play station of the second player is identical to that of the first play station. In this embodiment the first player becomes a primary winner and the second player is a secondary winner, both of whom share in the reward. Any of a number of formulas may be used for apportioning the reward between the first and second players. The invention further envisions a proxy additional reward wherein a player may wager on the possibility that the additional reward will be won at a play station identified by a number different from the player's own play station number. The proxy additional reward game may be played by requiring the player to deposit an additional reward token on one or more of the six numbered locations on a betting zone having locations marked for receiving tokes, one location for each of the six play stations. In our U.S. Pat. No. 5,573,248 we disclosed a craps game and table having six play stations for receiving six players at the game and a progressive game employing a first pair of dice for playing a conventional craps game and a third die for playing the progressive part of the game. Substantially the same rules apply to the game for the non-progressive reward. In the parent to the present application we also disclosed a baccarat game in which a player at a play station with a given number will win a progressive game if the first two cards in the player's hand and the first two cards in the banker's hand all bear numbers identical to the number of the play station. Those rules are also useable in playing for a non-progressive reward. In accordance with the present invention, the players at any combination of a number of types of casino games can vie for the same additional reward. To integrate a number of types of games to compete for a single additional reward, the number of play stations on each game table suitable for vying for the additional reward must be the same for all tables, or a multiple of that number. In the preferred embodiment the play tables of all games will have six play stations to accommodate six players or twelve stations to accommodate twelve players. A gaming table for craps was disclosed in our prior U.S. Pat. No. 5,573,248 would accommodate six players. The table disclosed by Jones U.S. Pat. No. 4,861,041 can be adapted to accept six players and in like manner all of the game tables of each type of game in the casino vying for the additional reward would have six play stations, each of which is numbered one through six, or twelve play stations in two sets of six numbered locations. The game can be configured such that there is only one winner when a winning combination arises. Alternately, when a first player at a first play station receives a winning combination, the rules can provide that a second player at a second table at a play station having a number identical to that of the first play station will share in the universal additional reward if he has deposited an additional reward token on the table. BRIEF DESCRIPTION OF THE DRAWINGS A better understanding of the present invention will be obtained after a reading of the following detailed description taken in conjunction with the drawings wherein: FIG. 1 is a top elevational view of a play surface for use with a game of baccarat; FIG. 2 is a top elevational view of a betting zone for a proxy additional reward; FIG. 3 is a top elevational view of play surface for use with a game of roulette; FIG. 4 is a roulette wheel for use in the table shown in FIG. 3; FIG. 5 is a top elevational view of play surface for use with a game of craps; FIG. 6 is a top elevational view of a play surface for use with a game of poker or blackjack; FIG. 7 is a shake container to be used with the crap table shown in FIG. 5; FIG. 8 is a schematic view of a bank of slot machines configured to participate in a game for an additional reward; and FIG. 9 is a schematic top view of an alternate embodiment of a baccarat table. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. 1, a baccarat table 10 has a banker's edge 11 allowing a dealer seated in a chair 12 to face a plurality of players positioned at play stations along the arcuate outer edge 13 . Six play stations 14 , 15 , 16 , 17 , 18 , 19 are depicted and each of the play stations bears an identification number such that the play stations 14 , 15 , 16 , 17 , 18 , 19 are numbered one through six respectively. The table includes an area 22 where the dealer can retain chips and a drop slot 26 into which cash exchanged by the gambling establishment for chips may be placed. An important element of the universal reward is that the same set of numbers (preferable 1 through 6 ) are assigned to the play stations of every table vying for the additional reward, and every table has the same given numbers (preferably 6 ) of separately numbered play stations or a multiple of that given number (preferably 12 ). Although the play stations 14 - 19 are described as being “numbered” and are depicted as bearing numerals 1 through 6 , it should be appreciated that the play stations could be identified by lettering them A, B, C, D, E and F. Other symbols may also be used to identify the various play station positions, and for the purposes of this discussion the terms “numbered,” “identification numbers” or “numbering” shall refer to all such methods of identification. Baccarat is generally played at a table which can accommodate more than six players, and a larger baccarat table such as shown in FIG. 9 can be employed with the present invention where numbers of play stations at a larger table are a multiple of the number of play stations at a smaller table. The table 27 is depicted as having twelve play stations divided into two groups of six with each group being numbered one though six. The rules of the game of baccarat are well known and are not set forth herein, however, each of the six play stations 14 - 19 has markings suitable for use in the game of baccarat including a player bet area 30 , a bank bet area 32 , and tie bet area 34 . The bet areas 30 , 32 , 34 are intended to receive chips from a player at the play station who desires to place a bet on the success of the player or the banker, or for a tie, on each hand of baccarat. Referring to FIGS. 1 and 2, each play station 14 - 19 also has a proxy additional reward betting zone 35 for receiving additional reward tokens for wagering on the proxy additional reward. The proxy additional reward betting zone 35 has six betting locations 36 in an array, the six locations numbered 1 through 6 as shown in FIG. 2 . To place a proxy additional reward bet on a play station number (including the number of the player's own play station) the player will deposit an additional reward token on the numbered location 36 for the play station number of his choice. Referring to FIG. 3, a roulette table 40 is generally rectangular in shape with a first long side 42 for use by a dealer, an opposing second long side 44 and first and second short sides 46 , 48 respectively. A roulette wheel 50 is positioned near the first short side 46 and a betting pattern 52 is positioned adjacent to the roulette wheel 50 and adjacent the first long side 40 such that a dealer can operate the wheel 50 and supervise bets. Four play stations numbered 53 , 54 , 55 , 56 , extend along the second long side 44 and two play stations numbered 57 , 58 extend along the second short side 48 as shown. The play stations 53 - 58 are numbered 1 through 6 respectively and each play station has a betting area 60 with markings thereon suitable for placing bets for the game of roulette. Each play station 53 - 58 further has a proxy additional reward betting zone 35 as described above and shown in FIG. 2 for use to bet on the proxy additional reward. Referring to FIG. 4, the wheel 62 used in conjunction with a progressive game has a stationary annular outer race 63 with ridges 64 and canoes 65 thereon, and an annular lip 66 surrounding the race 63 . The rotating central portion 67 of the wheel 62 includes a capstan 68 , and near the peripheral edge are the numbers 69 on the wheel. Inward of the numbers 69 is a separation ring 70 with a plurality of separator holes, one of each of the numbers 69 . In accordance with the present invention, the annular outer race 63 is divided into eight sections, 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 of which sections 71 , 72 , 73 are identified with indicia numbers 1 , 2 , and 3 respective and sections 75 , 76 , 77 are identified with indicia numbers 4 , 5 and 6 respectively as shown. Sections 74 and 75 are left unnumbered. The rules for playing roulette, like the rules of all casino games, are well known and are not set forth at length herein except for the portions thereof which relate to the progressive game. In the course of the game, players bet on one or more of the numbers 69 after which the central portion 67 is spun and the ball 79 is rolled around the race 63 and against the annular lip 66 . Eventually the ball 79 will come to stop in a hole identified by one of the numbers 69 . When the central portion 67 stops rotating, the numbered hole in which the ball has landed will be against one of the eight sections 71 - 78 . Referring to FIG. 5, crap table 80 has a substantially linear dealer's side 82 and an arcuate outer edge 83 with six play stations 84 , 85 , 86 , 87 , 88 , 89 , each of which is numbered 1 through 6 respectively as shown. The use of the table 80 and the rules of the game of craps are set forth in detail in our above mentioned prior U.S. Pat. No. 5,573,248 and are incorporated herein by reference. For the purposes of the present invention, however, the table 80 includes a bank roll 90 for use by a dealer positioned along the linear side 82 and each of the play stations 84 - 89 includes a proxy additional reward betting zone 35 allowing the players to wager for a proxy additional reward. Referring to FIG. 6, a table 96 suitable for use for a game of poker or a game of blackjack in a casino is depicted. The table 96 has a generally linear banker's side 98 , and an arcuate outer edge 100 along which are six play stations 102 , 103 , 104 , 105 , 106 , 107 numbered 1 through 6 respectively. Like the play stations of the preceding tables, the play stations of the poker and black jack tables has markings suitable for use by a player of the game. Each play station 102 - 107 also has a proxy additional reward betting zone 35 . In accordance with the present invention, each casino game has a preselected set of winning conditions for participating in the jackpot of a progressive game. In the preferred embodiment, the winning combination for baccarat would occur when the first two cards dealt to a player's hand and the first two cards dealt to a dealer's hand are all identical and are equal to the numerical identification of the play station at which the player is seated. For example, a player at station four has a winning combination when the player's hand and the banker's hand both have a pair of fours. Similarly, a player at play station six has a winning combination when the player's hand and the banker's hand both have a pair of sixes. For roulette, the preferred embodiment of the winning combination requires that a player first bet on a number associated with his play station. For example, the numbers 4 , 14 , 24 , and 34 are the numbers associated with play station four and the numbers 15 , 25 , and 35 are the numbers associated with play station five. The winning combination occurs when the ball lands in a number associated with the player's play station and the rotating portion of the wheel 69 comes to rest with the ball against the section 71 - 78 bearing the same number as that of the player's play position. In our prior U.S. Pat. No. 5,573,248 we disclosed how a progressive game can be linked to a crap table as shown in FIG. 5 where the dice are enclosed in a shake container 116 as shown in FIG. 7 . The container 116 is made of a transparent material such as acrylic and has a first chamber 118 for retaining a first pair of dice for use in the game of craps, and a second chamber 119 which retains a third die employed in the progressive game. A player at a play station bearing one of the numbers one through six has a winning combination when the shake container 116 is turned and causes the dice to tumble and come to rest with the numbers showing “up” on all three of the dice being identical and equal to the number assigned to his play station. Referring to FIG. 8, the winning combination for a player before a numbered slot machine 120 A to 120 F in a bank 121 occurs when the player has deposited the maximum number of coins into the machine 120 , including a coin into an additional reward game receptor 122 and, after pulling the handle, the reels display a combination for the top award available on the machine. When the winning combination occurs at a slot machine 120 and an additional reward token has been deposited in a receptor 122 , the machine 120 will send a signal to a central recording center 123 to acknowledge that the player has won both the jackpot for the machine and the additional reward. The slot machines 120 A to 120 F are preferably arranged in banks with the number of machines in each bank equal to the given number (preferable 6 ) and each machine in the bank bearing one of the set of numbers ( 1 to 6 ). Although the seat number of a slot machine is not a factor in determining whether the player is a winner when he pulls the handle, the seat number is important for determining whether the player is entitled to a portion of the additional reward. For poker, the winning combination occurs when a dealer's completed hand has four of a kind and the numbers on the four cards are equal to the identification number for the play station at which a player is positioned. For the game of blackjack, the winning combination occurs when the player's first two “up” cards are a pair and the dealer's first two cards (including the dealer's “up” cards and the dealer's “down” cards) are a pair and both are showing the same number as the player's play station. Experienced poker and blackjack players who are capable of remembering the cards that have previously been played can count the high cards and determine changes in the odds. Players who count cards find it desirable to be in the last play position, that is the sixth person to be dealt cards, which is the player to the dealer's right. It is desirable therefore for the dealer at the table to deal each hand starting with a different player by utilizing a marker as shown in our first U.S. Pat. No. 5,573,248, however, the rotation of the dealer position will not change the play station number for a player. To participate in the game for an additional reward a player will purchase additional reward tokens from the cashier at the same time that he is purchasing chips for use at the gaming tables. He will then sit at a play station bearing a number from the given set ( 1 through 6 ). While at the table the player will play the game of the table, and if he desires to participate in the play for the additional reward, he will deposit an additional reward token on the table. This can be done by placing the token in an area of the table marked for receiving additional reward tokens, or by placing the token in a place which according to prearranged terms, signals the dealer that the token is in play. The prearranged terms may require the player to place the token on top of a stack of tokens being wagered, or along sides of a stack of tokens being wagered. The player can also participate in a game for a proxy additional reward by depositing an additional reward token on the numbered location in the proxy additional reward betting array 35 . When a player who has deposited a token for an additional reward on the table obtains a winning combination, the dealer will acknowledge the winning combination thereby allowing the player to participate in the award. In one embodiment of the game, only the player who has the winning combination and has deposited a token to participate in the additional reward is a winner. In another embodiment all other players vying for the additional reward who have deposited tokens to participate in the additional reward and are sitting at a station bearing a number ( 1 through 6 ) identical to the number of the winning play station are secondary winners who participate in a percentage of the additional reward along with the primary winner having the winning combination. In a third embodiment, proxy additional reward players who have deposited tokens on the numbered betting zones 36 in their proxy additional reward betting array 35 which correspond to the number of the winning play station number would also participate in the reward. After each winner of the additional reward the casino will reinstate the additional reward jackpot and the play for the additional reward will be renewed. A unique quality of the universal additional reward game is that players at many types of games may all play to win a portion of the same additional reward. A single reward will therefore attract players into a wide number of table games. Another quality of the game is that in the conditions for winning the card games, namely blackjack and poker, the dealer's hand determines the winning combination. A player cannot, therefore, determine whether he is a winner until the hand is completed, thereby extending interest in the game until the end of the hand. While several embodiments of the present invention have been disclosed, it will be appreciated that many variations and modifications can be made without departing from the true spirit and scope of the present invention. Therefore, it is intended by the following claims to cover all such modifications and variations which come within the true spirit and scope of the invention.

1a

[0001] This application claims priority from U.S. Provisional Patent Application Serial No. 60/446,965 filed on Feb. 13, 2003 and U.S. Provisional Patent Application Serial No. 60/475,464 filed on Jun. 3, 2003. [0002] This application did not receive any federal research and development funding. BACKGROUND OF THE INVENTION [0003] The present invention relates generally to a safe environment to which an individual may retreat for protective or rest purposes. More specifically, the invention relates to a protective sleep unit that includes multiple protective and convenience features. This invention is directed towards providing users with a high-level security system for use during sleeping periods. It also acts as a place of retreat and defense against those desiring to inflict bodily harm upon a user. Lastly, the invention might be used as a protective environment during biological or chemical attacks and natural disasters. [0004] A safe room is a room having a reinforced door and walls for use in emergencies such as tornados or when an intruder enters a dwelling. Typically, the walls of the safe room comprise concrete or steel to protect individuals or items inside the safe room. Safe rooms have been used as a form of protection for many years. Safe rooms are limited in their use because of their weight and size. Ordinarily, they are built during an initial construction of a residence or during a remodeling of the residence. Alternatively, an installer fabricates the safe room outside the residential dwelling and hauls it into place. [0005] Problems that exist with a safe room include reinforcing structural members under and around the safe room during initial construction or remodeling of the residence. Hauling a safe room into place may require the removal of doors and/or walls. Thus, there are many problems associated with the use and installation of safe rooms. [0006] The present invention overcomes many of these problems associated with safe rooms. The protective unit of the present invention is shipped to a residence and constructed on-site. Individual or component parts are carried through standard-sized entryways thereby alleviating the need to remove doors and walls. Additionally, it does not require any further reinforcement of structural members within the residence. [0007] It is an object of the invention to provide a high-level security unit that includes a protective barrier between an intruder or dangerous environmental condition and a user. [0008] It is another object of the invention to provide a unit that includes high-level security during periods of sleep. The unit might be equipped with various sensors to alert a user when an intruder has entered the user's dwelling. [0009] It is a further object of the invention to provide a unit that includes a bulletproof shielding material for protecting an occupant. The shielding material is durable such that it can withstand the impact of large objects such as sledge hammers, wrecking bars and the like. [0010] It is an additional object of the invention to provide a sealed environment that protects an occupant from chemical, biological or other harmful airborne contaminants. The sealed unit may be used as a positive pressure system, that allows the user to bring in fresh filtered air and keep offensive agents such as pollen, mold spores, radioactive fallout, or viruses like SARS from entering the unit. Alternatively, the unit may be used as a negative pressure system to create an isolation environment that allows the user to contain events caused by airborne particles (like the transfer of a contagious virus). [0011] It is another object of the invention to provide a secured area that allows a user to see an area external to the closed unit while preventing others from peering into the unit. [0012] It is another object of the invention to provide a protective unit that protects against terrorism or, harmful biological agents such as Anthrax. The unit includes a security system for detecting intruders and reacting thereto. Bullet proof shielding protects the occupant from weapons of mass destruction including biological and chemical warfare. The unit can be operated as a safe room or bomb shelter. It may be used to prevent kidnappings, or protect the occupant from natural disasters such as tornados, hurricanes, earthquakes and floods. [0013] These objects and others will become apparent when the aforementioned discussion is taken in conjunction with the following disclosure. BRIEF SUMMARY OF THE INVENTION [0014] The present invention is a protective bed that includes a cover comprising plating or shielding material that encapsulates the bed when closed. This shielding comprises material that prevents bullet penetration as well as high impact blows. It also protects an occupant from forced entry and may provide a sealed environment to protect the occupant from harmful chemical or biological agents. [0015] The shielding comprises a canopy, leg cover, side and foot frame plating, back headboard plating and side headboard plating, as well as at least one access door. Typically, the shielding constitutes 1.25″ polycarbonate plating. However, it is contemplated that other known materials may be substituted for the polycarbonate plating. For example, the unit may be built with aluminum, steel, plastic or wooden bed frame and headboard with shielding options of wood panels, plastic, or aluminum sheet panels. The options for the canopy, leg covers, bed frame and headboard plating may comprise aluminum or steel plating, wood paneling, formed plastic, Plexiglas, thin polycarbonate or any combination of these materials. The shielding can be fitted with Kevlar®), a material designed to stop bullet penetration. The unit can be fabricated to provide a sealed temporary environment from harmful gasses. Access to the interior of the shielding material is gained through actuators discussed hereinafter. [0016] A shield operating system includes actuators or screw jacks for opening and closing the shielding and doors, such as those sold by Thomson Industries under the model number 12 VDC PPA or the Warner Electrak® E050 electromechanical linear actuator. The screw jacks include expansion boots that are rubber and cover the moving parts to prevent accidental contact with the moving parts during operation. Since the cover and doors are hinged externally, the actuators act as the locking mechanisms for the covers and doors when in the fully closed position to seal the unit and protect an occupant from forced entry. At least one screw jack actuator is provided for each the canopy and the leg covering. Each door is equipped with a door actuator that operates to open and close the doors. Each door actuator is fitted with a quick release button to allow the doors to be opened from inside the unit should a power failure occur. The quick release buttons are accessed through cover doors in the headboard that include flip guards for preventing accidental release during an emergency condition. [0017] This invention is aimed at providing users with a high-level security system during normal sleep periods. It can also be used for a place of retreat and defense against perpetrators such as burglars or other criminals that may break into homes with the intent of harming the homeowners or occupants. It is also suitable as a protective environment during times of biological warfare, chemical warfare or other harmful gas attack. The invention is intended for use by the public at large and has potential uses in the medical community. Governmental use may include protection of important government officials such as dignitaries and ambassadors from terrorism and weapons of mass destruction. In one embodiment, the unit comprises an aluminum bed frame and headboard with attached polycarbonate, bullet proof plating that is designed to provide a protective barrier (cover shields) between a perpetrator or environmental condition and the homeowners or occupants. An aluminum bed frame and headboard supports the bedding and shield covers. Sealant is applied between the frame and shielding to assure that an airtight environment is created when the unit is closed. The aluminum bed frame and headboard support the bedding and the shield covers. [0018] The bulletproof polycarbonate barrier is designed to stop bullet penetration, blows from impact, forced entry and provide a sealed temporary safe room and environment from burglars, terrorists or harmful gasses. It also provides protection from the destructive forces of tornados, hurricanes, earthquakes and floods. [0019] The unit can also be fitted with defensive devices such as a tear gas spraying device, robotic arms, or weaponry that propels projectiles. It is designed to enable the person(s) inside the unit to see out and prevent those outside from seeing in. The unit may be equipped with a bio-chemical filter system to counter bio-chemical attacks and a rebreather system to enable the operator to seal off all outside air and provide breathable air for a specified amount of time. This system might be used in such a case where the unit operator may need to release tear gas or another form of gaseous material in defense against a burglar or terrorist. The rebreather system is also useful as the ultimate protection (safe room) from weapons of mass destruction that may be used during biological and chemical acts of warfare or other type gas attack that could release various forms of pathogens or hazardous gases. [0020] There are doors on either side of the unit next to the headboard. The doors are equipped with actuators that include an emergency release button. When pressed, the emergency release causes the actuator to separate into two pieces. When separated, the actuator releases to allow the door to open. This feature is useful in case of mechanical failure of the actuator or loss of power to the operating systems that control the actuator. [0021] A control panel controls operating systems such as venting, opening and closing of the cover shield, telephone systems, sound systems such as audio amplifiers, microphones, radio and television systems, defensive systems, alarm systems, oxygen sensors, motion detection systems, and smoke detection systems. [0022] The unit may comprise an external keypad and remote control device for gaining entry to a closed unit. The unit also includes an environmental air conditioning and heating control system that regulates the internal temperature of the unit. The unit may comprise an alternative power source such as a battery system to provide power in the event of a failure or interruption of power in the primary power source. The unit might include automatic switching circuitry for switching from the primary to the alternative power source. The unit may also be equipped with a toilet or other plumbing system. [0023] The unit may be shaped in a circular instead of rectangular shape. It may include fire resistant materials such as fire retardant plastics and water circulation systems. It may be equipped with a video screen adapted to the head cover shield for playing video games and for computer hookups. Moreover, the unit may include integrated PC systems. Family systems comprising two or more units may be electronically linked together such that a parent or guardian can remotely operate a child's unit from the parent's sleeper. Communication systems allow audio and video communications between the units for viewing and talking with one another from the safety of the units. [0024] The unit includes a control panel that allows a user to select between different modes such as basic system operations, an intruder setting, an emergency status, and a lock down mode. The cover and door actuators include an emergency release. The unit may include a one-way see-through head cover comprising a reflective mirror on two sides and the front. [0025] The unit comprises a sensor system that includes sensory features such as a proximity sensor, oxygen sensor, smoke detector and motion detector. It may include an emergency communications system comprised of a cellular telephone or radio frequency transceivers. The unit may comprise convenience accessories such as a stereo system including a radio, compact disc player, DVD player, personal computer system, microwave oven and refrigerator. An external camera and video system may be provide for viewing areas outside the unit. [0026] When the unit protects against natural disasters, it is secured on a ground floor with a concrete slab foundation and anchored to a solid base to resist the forces of wind and water. [0027] Airtight and watertight seals surround the edges of the doors and along the edges where the shielding separates during opening and closing. The seal may be a seal comprised of ribbed sections and sold by Clean Seal Inc. A sealant is applied between the frame and headboard plating to assure an airtight seal. The matting surfaces of the covers and doors include grooves with rubber seals inserted into the grooves. The seals are ribbed EPDM material and can contain an atmospheric pressure between 5-9 psi depending upon the percent of compression. The unit is designed to compress the seal to 20% which will hold greater than 7psi. Additional stainless steel bridge structuring that incorporates angled designs is an optional feature that can be added to the head and leg covers. This additional bracing reinforces the polycarbonate plating for protection from earthquakes, tornadoes, hurricanes and flood waters. [0028] The unit includes a ventilation system that comprises filters and a rebreather. The unit may also be equipped with a heating and air conditioning system. The ventilation system is designed to circulate air through the unit while in the open or normal settings. The air may be circulated across heating or cooling coils to regulate the internal temperature of the unit. It automatically shuts off when sensing external hazardous conditions. The system includes filters, filter housing, a circulation fan, inlet and outlet isolation valves and ducting. The filter may be an ASR-48NBC filter sold by American Safe Rooms, Inc. Air flows in through filters located at the headboard end of the unit and out through openings located at the foot of the unit. Various filters may be used to satisfy individual needs. Some of these may include Hepa filters, dust filters, or biological and chemical filters. The filter housing transitions air flow from the filter to the ducting system. The ventilation system controls an internal atmosphere of unit to regulate temperature and humidity to a desired comfort level [0029] In the preferred embodiment, the duct system comprises 1.25″ duct. A fan circulating air throughout the unit may be activated by sensor input in response to environmental changes such as temperature and humidity. Alternatively, the fan may be operated on a continual basis. Vent isolation valves open and close main venting and rebreather systems. The valves used may be model number 62416 Parker solenoid valve 12VDC sold by valvestore.com. These isolation valves are automatically controlled by an O 2 sensor, smoke detector and LEL sensor. The valves are biased towards an open position such that when power failure occurs, they assume an open position. Redundant ducting provides a safety feature should fan failure occur or a valve become stuck in a closed position. [0030] A rebreather provides oxygenated air for breathing when the venting systems are closed for protection from hazardous external atmospheric conditions. The rebreather is activated when the ventilation system is shut off. The isolation valves open and the ventilation system circulates air throughout the unit. The rebreather provides a breathable atmosphere for up to 3 days. The rebreather system acts to remove or “scrub” carbon dioxide from the air and inject small amounts of oxygen back into the air stream. After the system is exhausted, such that it can no longer remove carbon dioxide from the air, the main ventilation system automatically opens to draw in air from outside the unit. That is to say, the unit is designed switch over from the rebreather to the outside atmosphere when the rebreather can no longer scrub carbon dioxide from the air and the oxygen level drops below a safe level, for example 19.5%. If activation of the ventilation system fails to restore internal oxygen to a safe level after a preset period of time, the unit opens the shielding or doors in an effort to raise the oxygen level. [0031] The unit includes a mattress and box springs. It also may include LEDs or other indicator lights that alert a user of a specific condition. Audible and visual alarms may be included in the unit for indicating the existence of a dangerous condition. The controller may include automatic responses to various environmental stimuli. For example, a glass breakage alarm may detect the sound of glass breaking in the house in which the unit is located. The unit may automatically close the shielding to protect an occupant. Authorities may then be alerted by the unit. BRIEF DESCRIPTION OF THE DRAWINGS [0032] [0032]FIG. 1A is a perspective view of a shielding system for a protective bed unit in a closed position. [0033] [0033]FIG. 1B is a perspective view of a shielding system for a protective bed unit in an open position. [0034] [0034]FIG. 2 is an elevation view of the protective bed unit from the side. [0035] [0035]FIG. 3 is an elevation view and showing the protective bed unit from a headboard end. [0036] [0036]FIG. 4 is an elevation view and showing the protective bed unit from a foot end. [0037] [0037]FIG. 5 is a cross section view of an air-tight seal. [0038] [0038]FIG. 6A is a perspective view of a frame for the protective bed unit. [0039] [0039]FIG. 6B is an elevation view taken from the side of the frame for the protective bed unit. [0040] [0040]FIG. 6C is an elevation view taken from the headboard end of the frame of the protective bed unit. [0041] [0041]FIG. 6D is an elevation view taken from the foot end of the frame of the protective bed unit. [0042] [0042]FIG. 7A is an elevation view of the protective bed unit and showing the cover operating system. [0043] [0043]FIG. 7B is an elevation view of a door actuator and showing the quick release button. [0044] [0044]FIG. 7C is an elevation view of the door actuator after the quick release button has been actuated. [0045] [0045]FIG. 8A is an elevation view of the protective bed unit and showing the ventilation system. [0046] [0046]FIG. 8B is a perspective view of the ventilation system and showing the rebreather. [0047] [0047]FIG. 8C is a plan view of the ventilation system. [0048] [0048]FIG. 9 is a schematic view of the electrical system of the protective bed unit. DETAILED DESCRIPTION OF THE INVENTION [0049] The following is the preferred embodiment or best mode for carrying out the invention. It should be noted that this invention is not limited by the discussion of the preferred embodiment, but that skilled artisans may easily recognize that certain modifications may be made without deviating from the spirit of the invention. [0050] Now referring to FIGS. 1A and 1B which depict the shielding system of the unit in a closed and open position, respectively. The shielding material comprises a canopy 1 and leg cover 2 . Typically, canopy 1 and leg cover 2 comprise polycarbonate material that includes a one-way mirror effect such that an occupant sees out while an intruder cannot see inside the closed unit. This effect may be achieved by coating the polycarbonate material with a dark window film that may be bought at auto supply or other such stores. The canopy 1 and leg cover 2 are hingedly affixed to back headboard plating 5 and foot frame plating 4 as shown in FIGS. 3 and 4. Thus, the shielding system may be opened as shown in FIG. 1B such that the occupant can sleep with the shielding in an open position. [0051] The shielding system also includes side frame plating 3 , foot frame plating 4 , back headboard plating 5 and side headboard plating 6 . The plating may comprise polycarbonate material or other alternative materials, some of which are listed above. The plating is affixed to the frame of the protective bed unit by fastening devices such as rivets or bolts. A sealant may be applied between the plating and the frame for assuring that an effective seal is created. [0052] Doors 7 comprise shielding material and are hingedly affixed to side headboard plating 6 for gaining access to the interior of the unit. The matting surfaces of the canopy 1 , leg cover 2 and doors 7 include grooves with rubber seals 8 inserted therein. The seals 8 are compressed when the unit is closed to create an airtight seal as shown in FIG. 5. [0053] [0053]FIGS. 2 through 4 are perspective views of the protective bed unit. Hinge 56 attaches door 7 to side headboard plating 6 . External hinges 56 also attach the canopy 1 and leg cover 2 to the headboard and foot frame plating respectively. Filters 24 and 25 are also attach to back headboard plating 5 . Outlet ducts 23 A allow filtered air to exit the air tight chamber. [0054] Now turning to FIGS. 6 A-D which show perspective views of the frame that supports the shielding system and bedding. The frame comprises side bed frame elements 9 that are formed in a box-like structure on either side of the unit as shown. Bed frame brace members 11 connect the two box-like structures together via fastening devices such as rivets. The box-like structures are fastened at one end to the foot bed frame elements 10 and at an opposite end to the headboard 12 . Hex head bolts and nuts 46 affix the side bed frame elements 9 to the headboard 12 . A mattress base 50 sits atop the box-like structures and is shown in phantom in FIG. 6B. Box spring 49 and mattress 48 rest atop the mattress base 50 . Actuator bases 13 are arranged as shown to provide support surfaces for lifting the canopy 1 and leg cover 2 . [0055] [0055]FIG. 7A depicts cover actuators 14 in the open and closed position. An end of a cover actuator includes an actuator mounting base plate 18 that is affixed to actuator base 13 . An opposite end of the actuator 14 attaches to an actuator mounting lift plate 19 that attaches to canopy 1 . Likewise, an actuator is coupled to leg cover 2 for raising it to an open position or lowering it into a closed position as shown. [0056] Each door 7 includes a door actuator 15 for opening and closing the doors. The door actuator 15 includes a quick release link 20 for manually disengaging the actuator 15 . Bolts 57 secure the halves of the quick release link 20 to the actuator 15 . A spindle 20 D having a key notch and projecting from first half 20 A couples the halves 20 A and 20 B together. Half 20 B includes a female complementary receptacle (not shown) for accepting the spindle 20 D. [0057] Now turning to the ventilation system shown in FIGS. 8A through 8C, the ventilation system includes two filters a hepa/dust filter 24 and a bio-chemical filter 25 . The hepa/dust filter 24 is used during ordinary venting operations. In emergency situations such as during a gas attack, the bio-chemical filter 25 filters the air supply entering the unit. The unit may automatically switch from the dust filter 24 to the bio-chemical filter 25 when the bio-chemical agent sensor 32 detects the presence of an agent. [0058] Vent fans 21 pull external air through the filters 24 and 25 . Arrows shown in these drawings indicate the direction of air as it flows through various parts of the ventilation system. Vent solenoid valves 22 control whether the air will be circulated through the rebreather 26 . Valves 22 A and 22 B control the flow of air through either of the filters 24 and 25 . These valves are electronically controlled by the control panel 34 and may be switched over automatically in response to warning sensors. As can be seen in FIG. 8A, air flows into one of the filters 24 or 25 and through duct 23 through valve 22 A and into the unit. The air is then pushed out of the unit through valve 22 B. These valves 22 A and 22 B are closed when the rebreather 26 is being operated. As shown in FIG. 8B, when the rebreather 26 is in operation, air is pulled through valve 22 D into the rebreather 26 and is scrubbed to remove carbon dioxide and replenish oxygen. The air is pushed through valve 22 C and re-circulated into the interior of the unit. [0059] [0059]FIG. 9 shows a block diagram of the electrical system of the protective bed unit. A motion detector 27 detects motions in the area around the protective bed unit. The operator may place the control panel in a mode that either an alarm may sound or the unit may automatically close should motion be detected around the unit. The controller may also include a feature for detecting glass breakage and acting according to preprogrammed directions. [0060] A smoke detector 29 alerts an occupant when smoke is detected. Oxygen sensor 30 sounds an alarm when the oxygen content of the air becomes too low for safe breathing conditions. An LEL sensor 31 detects the presence of natural or LP gas. Bio-chemical agent sensor 32 senses the presence of biological or chemical agents. Other such sensors and detectors may be included such as pressure sensor 55 . Sensors may include those sold by Figaro such as a carbon dioxide sensor model number TGS4160, and oxygen sensor model KE-25. The control panel 34 allows the user to select from a wide variety of modes. An external key pad 35 provides a means for locking the door 7 of the unit when away. A user then enters a numerical password to gain entry into the unit. Cabinet lights 33 are included in the unit for providing a user with a light source. [0061] The unit may include a remote unit 37 for remotely controlling the unit. A heating and air conditioning unit 38 provides climate control for the interior temperature of the unit. The unit may be equipped with a refrigerant gas sensor 39 for detecting the leaking of coolant gas into the unit, which may lead to a dangerous condition. The heating and air conditioning unit 38 to maintain a desired temperature uses a thermostat 40 or temperature sensor. [0062] The unit includes a backup power source 42 for operating the unit when the primary power source has failed. The system might include visual warning lights such as LED 43 . An audio amplifier 51 amplifies external sounds such that the user can hear them being broadcast through speakers 52 . A communication system 53 is provided as discussed above. Entertainment system 54 may include a stereo, DVD player, television or the like.

1a

RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 61/826,704, entitled “System and Method for Stimulating the Heart via the Vagus Nerve” filed May 23, 2013, the entire contents of which are hereby incorporated by reference for all purposes. BACKGROUND The heart is divided into the right side and the left side. The right side, comprising the right atrium and ventricle, collects and pumps de-oxygenated blood to the lungs to pick up oxygen. The left side, comprising the left atrium and ventricle, collects and pumps oxygenated blood to the body. Oxygen-poor blood returning from the body enters the right atrium through the vena cava. The right atrium contracts, pushing blood through the tricuspid valve and into the right ventricle. The right ventricle contracts to pump blood through the pulmonic valve and into the pulmonary artery, which connects to the lungs. The blood picks up oxygen in the lungs and then travels back to the heart through the pulmonary veins. The pulmonary veins empty into the left atrium, which contracts to push oxygenated blood into the left ventricle. The left ventricle contracts, pushing the blood through the aortic valve and into the aorta, which connects to the rest of the body. Coronary arteries extending from the aorta provide the heart blood. The heart's own pacemaker is located in the atrium and is responsible for initiation of the heartbeat. The heartbeat begins with activation of atrial tissue in the pacemaker region (i.e., the sinoatrial (SA) node), followed by cell-to-cell spread of excitation throughout the atrium. The only normal link of excitable tissue connecting the atria to the ventricles is the atrioventricular (AV) node located at the boundary between the atria and the ventricles. Propagation takes place at a slow velocity, but at the ventricular end the bundle of His (i.e., the electrical conduction pathway located in the ventricular septum) and the bundle braides carry the excitation to many sites in the right and left ventricle at a relatively high velocity of 1-2 m/s. The slow conduction in the AV junction results in a delay of around 0.1 seconds between atrial and ventricular excitation. This timing facilitates terminal filling of the ventricles from atrial contraction prior to ventricular contraction. After the slowing of the AV node, the bundle of His separates into two bundle branches (left and right) propagating along each side of the septum. The bundles ramify into Purkinje fibers that diverge to the inner sides of the ventricular walls. This insures the propagation of excitatory waveforms within the ventricular conduction system proceeds at a relative high speed when compared to the propagation through the AV node. When the heart is working properly, both of its lower chambers (ventricles) pump at the same time as, and in synchronization with, the pumping of the two upper chambers (atria). Up to 40 percent of heart failure patients, however, have disturbances in the conduction of electrical impulses to the ventricles (e.g., bundle branch block or intraventricular conduction delay). As a result, the left and right ventricles are activated at different times. When this happens, the walls of the left ventricle (the chamber responsible for pumping blood throughout the body) do not contract simultaneously, reducing the heart's efficiency as a pump. The heart typically responds by beating faster and dilating. This results in a vicious cycle of further dilation, constriction of the vessels in the body, salt and water retention, and further worsening of heart failure. These conduction delays do not respond to antiarrhythmics or other drugs. Patients who have heart failure may be candidates to receive a pacemaker. A pacemaker is an artificial device to electrically assist in pacing the heart so that the heart may pump blood more effectively. Implantable electronic devices have been developed to treat both abnormally slow heart rates (bradycardias) and excessively rapid heart rates (tachycardias). The job of the pacemaker is to maintain a safe heart rate by delivering to the pumping chambers appropriately timed electrical impulses that replace the heart's normal rhythmic pulses. The device designed to perform this life-sustaining role consists of a power source the size of a silver dollar (containing the battery), and control circuits, wires or “leads” that connect the power source to the chambers of the heart. The leads are typically placed in contact with the right atrium or the right ventricle, or both. They allow the pacemaker to sense and stimulate in various combinations, depending on where the pacing is required. Either cathodal or anodal current may be used to stimulate the myocardium. The pulses produced by most pacemakers are typically cathodal and excitatory. That is, the cathodal pulse is of sufficient magnitude and length to cause the heart to beat. Cathodal current comprises electrical pulses of negative polarity. This type of current depolarizes the cell membrane by discharging the membrane capacitor, and directly reduces the membrane potential toward threshold level. Cathodal current, by directly reducing the resting membrane potential toward threshold has a one-half to one-third lower threshold current in late diastole than does anodal current. Anodal current comprises electrical pulses of positive polarity. The effect of anodal current is to hyperpolarize the resting membrane. On sudden termination of the anodal pulse, the membrane potential returns towards resting level, overshoots to threshold, and a propagated response occurs. The use of anodal current to stimulate the myocardium is generally discouraged due to the higher stimulation threshold, which leads to use of a higher current, resulting in a drain on the battery of an implanted device and impaired longevity. Additionally, the use of anodal current for cardiac stimulation was discouraged due to the suspicion that the anodal contribution to depolarization can, particularly at higher voltages, contribute to arrhythmogenesis. It has been shown that pacing in which a combination of cathodal and anodal pulses of either a stimulating or conditioning nature preserves the improved conduction and contractility of anodal pacing while eliminating the drawback of increased stimulation threshold. The result is a depolarization wave of increased speed. This increased propagation speed results in superior cardiac contraction leading to an improvement in blood flow. Improved stimulation at a lower voltage level also results in reduction in power consumption and increased life for pacemaker batteries. Vagal nerves innervate the sinus node, the atrioventricular conducting pathways and the atrial muscle. Stimulation of either vagus nerve slows the heart by its effect on the above-mentioned structures. The latency of the response of the sinus node is very short, and the effect of a single vagal impulse depends on the phase of the cardiac cycle during which it is applied. Thus, vagal stimulation results in a peak response either in the first or the second beat after its onset. The slowing of heart rate increases with the frequency of vagal stimulation and the relationship of this to pulse interval is linear. Sympathetic postganglionic fibers innervate the entire heart, including the sinus node, the AV conducting pathways and the atrial and ventricular myocardium. Increased activity of the sympathetic nerves results in increase in heart rate and force of contraction. In addition, the rate of conduction through the heart is increased and the duration of contraction is shortened. When sympathetic activity increases, there is a latent period of up to five seconds before an increase in heart rate, which reaches a steady level after about 30 seconds. This is in marked contrast to vagal effects, which are almost instantaneous. The frequency of sympathetic activity is also linearly related to heart period with the right sympathetic nerve having a greater effect on sinus node rate than the left sympathetic nerve. SUMMARY In an embodiment, a memory is configured to store one or more anodal waveforms, cathodal waveforms, and biphasic waveforms. A waveform or a combination of waveforms may be selected from the memory by a processor based on sensor data, data about the user and rules also stored in the memory. The stored waveforms comprise waveform data that are used by the multi-phase cardiac stimulus generator to produce waveforms for applying to the heart and/or the vagus nerve. DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate exemplary embodiments of the invention, and together with the general description given above and the detailed description given below, serve to explain the features of the invention. FIG. 1 is a schematic representation of the electrical activity of a typical heartbeat as is known in the prior art. FIG. 2 is a schematic representation illustrating a cardiac stimulation device according to an embodiment. FIG. 3 is a schematic representation illustrating a cardiac and vagus nerve stimulation device according to an embodiment. DETAILED DESCRIPTION As used herein, the term “pulse” refers to a single occurrence of an electrical signal that has a defined shaped and period. As used herein, the term “waveform” refers to a repeating electrical signal that may include one or more pulses. The pulses that make up the waveform may be the same or may differ in any one of shape, polarity, duration and amplitude. For example, a biphasic waveform may include an anodal pulse and a cathodal pulse. The anodal and cathodal components may differ only in polarity or may be differ in shape, polarity, duration and amplitude. Pulses making up a waveform may differ in shape, polarity, duration, and amplitude but be equivalent in power. As used herein, the term “sub-threshold waveform” refers to a waveform that does not result in stimulating the heart to beat. A waveform may be sub-threshold because the amplitude of the waveform is below an amplitude threshold value necessary to stimulate a heartbeat. A waveform may be sub-threshold because the duration of the waveform is below a duration threshold value necessary to stimulate a heartbeat. A waveform may be sub-threshold because the power of the waveform is below a power threshold value necessary to stimulate a heartbeat. As used herein, the term “pacing waveform” refers to a waveform that stimulates a heartbeat, results in depolarization and is by definition equal to or greater than a threshold necessary to simulate a heartbeat. FIG. 1 shows a representative tracing 10 of electrical activity in a typical heartbeat. A P wave 11 represents the wave of depolarization that spreads from the SA node throughout the atria. A period of time from the onset of the P wave to the beginning of a QRS complex is known as the P-R interval 12 . The P-R interval 12 represents the time between the onset of atrial depolarization and the onset of ventricular depolarization (typically lasting 20-200 ms). If the P-R interval is >200 ms, there is an AV conduction block, which is also known as a first-degree heart block if the impulse is still able to be conducted into the ventricles. A QRS complex 13 represents the period of ventricular depolarization, which normally occurs very rapidly (e.g., typically lasting 80-120 ms). If the QRS complex is prolonged, conduction is impaired within the ventricles. The isoelectric period (ST segment 14 ) following the QRS complex 13 is the period of time (typically lasting 80-120 ms) at which the entire ventricle is depolarized and roughly corresponds to the plateau phase of the ventricular action potential. The ST segment 14 is important in the diagnosis of ventricular ischemia or hypoxia because under those conditions, the ST segment 14 can become either depressed or elevated. FIG. 2 is a schematic representation illustrating a multi-phase cardiac stimulus generator 120 implanted in a patient according to an embodiment. In an embodiment, one or more sensors sense rhythm and contractions of the patient's heart 105 using at least one of atrial sensing and ventricular sensing, such as at least one of atrial sensor 110 and ventricular sensor 112 . The atrial sensor 110 and/or ventricular sensor 112 provide sensor data to a rules engine 122 . In an embodiment, the rules engine includes a processor 126 and a memory 124 for storing rules and receiving sensor data. The rules engine 122 may poll the one or more of the atrial sensor 110 and the ventricular sensor 112 to obtain sensor data and to apply the rules to the sensor data in order to determine whether to deliver electrical waveforms to one or more electrodes, and, if electrical waveforms are to be delivered, which of the one or more electrodes is to receive the electrical waveforms. In an embodiment, the one or more electrodes may be an atrial electrode 114 and a ventricular electrode 116 , and may provide electrical waveforms to at least one of an atrial chamber and a ventricular chamber of the heart 105 . The multi-phase cardiac stimulus generator 120 may generate an anodal waveform, a cathodal waveform, and a biphasic waveform above or below threshold depending on the sensor data and the rules applied by the rules engine 122 . In an embodiment, the memory 124 of the rules engine 122 of the multi-phase cardiac stimulus generator 120 is configured to store one or more anodal waveforms, cathodal waveforms, and biphasic waveforms. A waveform or a combination of waveforms may be selected from the memory 124 by the processor 126 based on sensor data and based on rules also stored in memory 124 . In an embodiment, the memory 124 may also store information about the patient 100 . The processor 126 may further select a waveform or a combination of waveforms from the stored waveforms based on the sensor data and data about the user. In an embodiment, the stored waveforms comprise waveform data that are used by the multi-phase cardiac stimulus generator 120 to produce waveforms for applying to the heart. FIG. 3 is a schematic representation illustrating a cardiac and vagus nerve stimulation device according to an embodiment. FIG. 3 includes elements from FIG. 2 and additionally includes a vagus electrode 310 for stimulating the vagus nerve 305 . In an embodiment, the vagus nerve 305 is accessed in the neck. The carotid sheath is dissected and the vagus electrode 310 is an encircling electrode that is wrapped around the vagus nerve 305 to receive electrical stimulation. In an embodiment of the present invention, the one or more of atrial sensor 110 and ventricular sensor 112 provide sensor data that indicates the onset of tachycardia. In response to the heart sensor data, the rules engine 122 may apply an electrical waveform to the vagus nerve 305 via the vagus electrode 310 . The rules engine 122 monitors the sensor data to determine when a sinus rhythm has been reestablished in the cardiac tissue. If a sinus rhythm has been reestablished in the cardiac tissue, the rules engine 122 halts the stimulus to the vagus electrode 310 . If a sinus rhythm has not been reestablished in the cardiac tissue, the rules engine 122 continues the stimulation of the vagus nerve 305 . In an embodiment, the electrical waveform may be low frequency or high frequency electrical signal or a waveform made up of trains of electrical pulses. In an embodiment, the electrical waveform is a biphasic waveform. In another embodiment, the stimulation of the vagus nerve may be combined with the application of a sub-threshold waveform to the heart as previously described. A system and method for reducing stroke work in an artificially paced heart have been disclosed. It will also be understood that the invention may be embodied in other specific forms without departing from the scope of the invention disclosed and that the examples and embodiments described herein are in all respects illustrative and not restrictive. Those skilled in the art of the present invention will recognize that other embodiments using the concepts described herein are also possible. Further, any reference to claim elements in the singular, for example, using the articles “a,” “an,” or “the” is not to be construed as limiting the element to the singular.

1a

This is a continuation, of application Ser. No. 080,446 filed Oct. 1, 1979, now abandoned. BACKGROUND OF THE INVENTION 1. Field Of The Invention This invention relates to the use of foam for preventing and extinguishing fires and, more particularly, to a method and apparatus in which a halogenated hydrocarbon such as trifluorobromomethane (CF 3 Br) is used to create a fire-fighting foam or is added as a gas to the bubbles of a fire-fighting foam. 2. Description Of The Prior Art Over the years, a number of techniques using foams have been used for extinguishing fires, particularly those involving gasoline and other volatile substances. Because of their many advantages, Aqueous Film Forming Foam (AFFF) systems are widely used in fighting fires. AFFF systems are effective in use because they contain a surfactant to reduce the surface tension of aqueous solutions to such a degree that the solutions will wet and spread upon non-polar and water immiscible solvents even though such solvents are lighter than water; they form a fuel or solvent vapor barrier which will rapidly extinguish flames and prevent re-ignition and reflash. Examples of compositions useful in AFFF systems are taught in the prior art by P. J. Chiesa, Jr. in U.S. Pat. Nos. 3,849,315 and 4,038,195; by R. A. Falk in U.S. Pat. No. 4,042,522; and R. Bertocchio in U.S. Pat. No. 4,069,158; and by others. One of the problems of prior art foam systems, including the AFFF systems, is that as the foam breaks down due to the heat and other effects of a fire, air is released from the foam bubbles as they break down. The air, of course, serves to negate the extinguishing effects of the foam by feeding the fire. To overcome this disadvantage it has been proposed by R. L. McElroy et al, in U.S. Pat. No. 1,829,714, to use foam produced by a mixture of bicarbonate of soda and aluminum sulfate in water and other compounds such that a fire suppressing gas is released when the foam breaks down. In the prior art also R. L. Tuve et al. have addressed the problem by covering the fire with a fire-extinguishing dry powder and thereafter covering the powder with a perfluorocarbon foam. It was known, of course, to introduce a fire-inert gas or a compound producing such inert gas into the atmosphere surrounding a fire or potential fire to extinguish or prevent a fire. The first gases used in the technique, such as carbon dioxide, operate primarily to deny the fire sufficient oxygen to support combustion. Other effects of the technique are to dilute flammable vapors and to cool flammable vapor/air mixtures. It has been found that volatile fluorohalocarbons containing bromine, such as CF 3 Br, C Br ClF 2 , C Br 2 F 2 , and C F 2 Br-CF 2 Br, are strikingly more effective in extinguishing a fire than are the older fire-inert gases. Because of the great efficacy of CF 3 Br (marketed commercially as Halon 1301 by E. I. DuPont de Nemours and Company, Wilmington, Delaware), it has been postulated that compounds of this class, instead of smothering a fire, extinguish it by capturing free-radicals thus terminating flame reactions. Even though they demonstrate a marked superiority over the compounds producing the older fire-inert gases, the bromine-containing fluorocarbons are only slowly finding a market because of their relatively high cost when used in accordance with conventional practice. In spite of the clear advantages of the compounds of this class in terminating flame reactions, the prior art produces no teachings of their use in a foam fire-extinguishing system. There is a teaching; however, by C. Herbline, in U.S. Pat. No. 3,529,670, of the use of a fluorohalocarbon, chlorobromodifluoromethane, in a fire-extinguishing system to pressurize a liquid such as water or oil such that the liquid can thereby be propelled from its container and on to a fire, the release of pressure upon leaving the container turning the propelled mixture into heavily halogenated icicles or snow. It will be seen, therefore, that the disclosure of C. Herbline concerns itself with a fire-fighting system employing a projected solid rather than a foam as is the case in the present invention. SUMMARY OF THE INVENTION Various foam systems are widely used in fighting or preventing fires. In these systems, the fluid, such as AFFF compound, expands 10 to 1 in the dispensing nozzle, aspirating air when so doing to thereby form the foam bubbles. Foam fire fighting systems in use today typically employ a light water aqueous film-forming compound, a protein compound, or the like, to produce the foam. My invention is based on the discovery that the addition of a proportional amount of a halogenated hydrocarbon compound such as Halon 1301 (CF 3 Br) into the foam projecting apparatus itself results in the fire extinguishing compound being added as a gas into each of the air bubbles of the air-aspirated foam. For convenience of exposition, the halogenated hydrocarbon compound will be referred to herein as a halogen. This addition of the compound to the foam not only increases the fire fighting ability of the foam as described herein previously, but increases the expansion rate of the foam and, in addition, increases the distance the foam is projected by the apparatus to thereby achieve greater coverage and greater penetration of the foam into the fire. Moreover, I have also found that the injection of the halogenated gas into the fire-fighting liquid produces a foam in the hose or pipe line, the bubbles of foam containing substantially only halogen, even with a plain, smooth bore hose nozzle. Inasmuch as conventional foam-generating nozzles utilize an orifice plate or other means acting on the flow to generate a foam, the ability of the technique of this invention to produce a foam with a plain nozzle means that the nozzle presents a minimum obstruction to the flow therethrough. This factor as well as the greater inertia of the foam because the halogen is heavier than air plus the increase in volume resulting when the compound-laden flow expands through the nozzle results in a significant increase in the projection range of the apparatus. It is thus a principle object of the invention to provide a method and apparatus for use with foam-type fire fighting equipment by which a halogenated hydrocarbon compound can be injected into the bubbles of the foam projected by the equipment such that the breakdown of the bubbles in the fire introduces a fire-fighting agent therein that enhances the effectiveness of the foam. It is another object of the invention to provide means for use with foam-type fire fighting systems that increases the expansion rate of the bubbles in the foam and the distance the foam is projected such that the range and coverage of the system is enhanced thereby. A further object of the invention is to provide an uncomplicated, practical, inexpensive means for employing halogens such as bromine-containing fluorocarbons to fight or prevent fires. Yet another object of the invention is to provide means by which a foam useful in fighting fires can be produced with a plain, smooth bore hose nozzle to thereby avoid the performance and cost penalties associated with the use of conventional foam producing apparatus. Still another object of the invention is to provide means for adding a gas that is heavier than air to the bubbles in a fire-fighting foam to increase its momentum to enable it to be projected to a greater range. Still another object of the invention is to accomplish the foregoing objects in a practical, safe, reliable manner that will comply with all applicable current local, state, and federal regulations. Other and further objects of the invention will be obvious upon an understanding of the illustrative embodiments about to be described, or will be indicated in the appended claims, and various advantages not referred to herein will occur to one skilled in the art upon employment of the invention in practice. DESCRIPTION OF THE DRAWINGS For the purpose of illustrating the invention, there is shown in the drawings the forms which are presently preferred; it should be understood, however, that the invention is not necessarily limited to the precise arrangements and instrumentalities shown. FIG. 1 is a schematic representation of a turret nozzle fire-fighting system embodying the halogen injection system of the invention; FIG. 2 is a front elevational view of the halogen injection means embodied in the system of FIG. 1; FIG. 3 is a schematic representation of a fire fighting foam-pumping system embodying the halogen injection system of the invention; FIG. 4 is a schematic representation of an alternate turret nozzle fire-fighting system embodying the halogen injection system of the invention; and FIG. 5 is a schematic representation of the halogen injection system of the invention embodied in a hose line fire-fighting system. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings, particularly to FIG. 1, which illustrates the system of the invention embodied in mobile fire-fighting equipment. Mobile equipment typically includes a turret foam nozzle 10, a tank 12 containing the foam-type extinguishing fluid, piping 14 connecting the fluid tank with the turret nozzle, and a pump 16 in piping 14 for pumping the extinguishing fluid from the tank for delivery to the foam nozzle at the required flow rate and pressure. Typically, ancillary components such as relief valves, check valves, supply valves, drain valves, vents, and the like known components of a mobile system will also be provided but their function is well known and for the interests of brevity and clarity, they will not be shown nor described herein. Turret foam nozzle 10 is mounted at any suitable location on the vehicle such as upon the roof 18 of the cab 20 thereof. The fire-extinguishing compound dispensed as a foam out of the nozzle can be a AFFF compound, a protein compound, or any other well-known extinguishing agent in common use. It will be recognized that the equipment set forth in the foregoing description is representative of apparatus in common use. In this invention, a halogen such as a bromine-containing fluorocarbon, preferably CF 3 Br, from a storage tank or supply receptacle 22 is passed through tubing 24 to a collar 26 on the turret nozzle 10 and is metered into the foam-forming compound flowing therethrough. The metering collar 26 comprises a ring-shaped tubular manifold 28 connected by means of a T-fitting 30 to the halogen supply tube 24 from the storage tank 22. Equally spaced around the manifold 28 are a plurality of metering nozzles 32 each having a suitably sized metering orifice 34 in the radially inward end 36 thereof (see FIG. 2). The manifold is fixedly positioned at the air induction opening 38 of the nozzle by means of radial rods 40 secured to a mounting ring 42 which is suitably fixed on the breech 44 of the nozzle. The halogen system will be provided with the elements usually present in fluid supply equipment such as a shut-off valve 46 on the storage tank 22, a check valve 48 in tubing 24 and the like. In operation, as is the usual practice in mobile apparatus, the operation of the foam dispensing system including such functions as the opening of the necessary valves, the initiation of pumping, the pointing of the turret nozzle, is controlled remotely by an operator at a control station or console. It will be appreciated that shut-off valve 46 can be coupled into the automatic control system to permit the remote operation thereof. At the scene, therefore, the operator will initiate pumping to establish a stream of foam out of nozzle 10 which is directed at the fire or other area of interest. At that time or thereafter as desired, the shut-off valve 46 is opened and a flow of halogen under storage pressure will be delivered to the metering collar 26 via tubing 24. Halogens such as CF 3 Br are normally stored in a pressure vessel at a saturated vapor pressure that is typically 200 pounds per square inch gauge at 75° F. At the collar, the halogen is sprayed, as indicated at 50, through the metering orifices 34 at a rate of 15 pounds of compound per 250 gallons of extinguishing agent per minute into air (indicated by arrows 52) induced into air induction opening 38 of the nozzle 10. This halogen-laden air mixes with the extinguishing agent passing through the nozzle to form a foam having halogen in the bubbles thereof. A further embodiment of the invention for entraining a halogen into a foam system is illustrated in FIG. 3. Unlike the FIG. 1 embodiment in which the foam is generated in the turret foam nozzle 10 of the system, in the FIG. 3 embodiment a plain nozzle 110 is provided and the foam is generated for delivery therethrough by a foam pump system 112. Foam-pumping systems are in everyday use and it thus is believed that it would serve no useful purpose to provide a detailed description herein. Suffice it to say; however, that in a typical system, water from pipe 114 connected to water supply tank 116 and light water or other suitable foam liquid from pipe 118 connected to supply tank 120 is mixed in an appropriate mixing chamber in the foam-pumping apparatus 122 with air induced through a screened opening 124 and the resulting foam is pumped through pipe 126 to the nozzle 110 to be projected therefrom. Because the foam is generated in apparatus 122, the nozzle 110 can be a plain nozzle and can be of the monitor type mounted on the floor or deck 128 of the vehicle (not shown). The foregoing will be recognized to be a description of a conventional foam pump system. My invention is embodied therein by the provision of a halogen system comprising a halogen storage tank 130 from which halogen under storage pressure is passed through tubing 132 to a T-fitting 134 and from thence through tubes 136 and 138 to metering nozzles 140 and 142 respectively opening into the foam-mixing chamber in the foam-pumping apparatus 122. The halogen system will be provided with the usual shut-off valve 144 on the storage tank 130, a check valve 146 in tubing 132, and the like elements of a fluid supply system. In operation, when the mobile equipment reaches the scene of operations, the operator aims the monitor nozzle 110 and the pump of the foam pump system will be turned on in the conventional way to produce a stream of foam that is projected out of the nozzle. At the same time the foam pump system is turned on to begin delivery of foam to the nozzle or when desired thereafter the shut-off valve 144 is opened. A flow of halogen, which typically is contained in tank 130 at a saturated vapor pressure of 200 psig at 75° F., passes through the associated tubing 132, 136, and 138 and is sprayed at a rate of 15 lbs. of compound per 250 gals. of extinguishing agent through the metering nozzles 140 and 142 into the foam mixing chamber of the pumping apparatus 122. There the halogen mixes with the foam being generated such that when the foam is projected out of nozzle 110, the halogen is entrained in the bubbles of the foam and is carried therewith to the area being foamed. In the embodiments of the invention just described, a halogen is mixed into foam being generated in a foam nozzle or in a foam generating pump system. I have discovered, however, that it is possible to produce a foam out of a standard water nozzle and without a foam generating pump system or a foam nozzle simply by injecting a halogen into light water or other extinguishing liquid being piped to the plain nozzle. Thus, referring now to FIG. 4 illustrating a typical mobile unit including a plain turret nozzle 310, a tank 312 containing extinguishing liquid, piping 314 connecting the liquid tank with the nozzle, and a pump 316 in piping 314 for pumping the liquid from the tank for delivery out of the nozzle at a required flow rate and pressure. As stated in the description of the FIG. 1 embodiment, the system will have the usual ancillary components of mobile fire-fighting apparatus. Turret nozzle 310 is mounted at any suitable location on the vehicle such as upon the roof 318 of the cab 320 thereof. The halogen system of this invention comprises a pressure vessel or storage tank 322 from which halogen is passed through tubing 324 to a metering nozzle 326 opening into the interior of liquid pipe 314. The usual elements present in fluid supply equipment such as a shut-off valve 328 on tank 322, and a check valve 330 in tubing 324, and the like elements in common use can be provided as required. Also, if desired, the shut-off valve 328 can be connected in a well-known way into the remote control system of the mobile apparatus by suitable means not shown so that the halogen feed system can be activated remotely from a control station by an operator when the pump 316 is turned on. In operation, the shut-off valve 328 is opened to initiate a flow of halogen through tubing 324 and into the liquid supply pipe 314 through metering nozzle 326 and the pump 316 is engaged. The metering orifice of nozzle 326 is sized to meter the halogen at storage pressure into the liquid at a rate of 0.060 lbs. of compound per gallon of extinguishing liquid per minute. As the liquid with the halogen entrained therein passes out the nozzle, a foam whose bubbles are substantially filled with halogen is produced. It is believed that the phenomenon involved is that the release from confinement of the halogen liquid mixture enables the halogen to expand and thereby produce a foam. It is also believed that this increase in volume of the halogen in changing phase as well as the increase in the inertia of the foam because the halogen is heavier than air also act to produce the significant increase brought about by this invention in the distance the stream of foam is projected by the nozzle, thereby enhancing the safety aspects and efficiency of the operation. FIG. 5 illustrates the halogen system of this invention embodied in a conventional hose or hand line 410 stowed on a reel 412. The reel, which is suitably mounted on a floor or deck 414, comprises a framework 416 having a shaft 418 mounting a spool 420 for rotation such that the hose 410 can be unwound or wound thereon for stowage. FIG. 5 shows the hose wound on the spool in the stowed position. Reel 412 is of the continuous-flow type in which the piping 422 from the supply tank 424 is connected to a swivel joint inlet 426 which, in turn, passes through the reel hub 428 and is connected to the reel end of hose 410 by an outlet riser (not shown) such that the extinguishing liquid can be dispensed through the hose even though it is partially or even wholly wound on the reel. A conventional pump 430 is provided in pipe 422 to supply the extinguishing liquid to the plain nozzle 432 at the required flow rate and pressure. It should be mentioned that, when reference is made herein to a "plain" nozzle, the designation is intended to indicate that the nozzle can be of the plain straight or tapered bore type and need not be provided with mechanical means to create a foam. The halogen system in this embodiment comprises a storage tank 434 from which halogen is passed through tubing 436 to a metering nozzle 438 opening into the flow passing through the swivel joint inlet 426. The usual shut-off valve 440 on tank 434 and a check valve 442 in tubing 436 and the like are provided. In operation, the pump 430 will be actuated to prime the system and the hose will be deployed. The shut-off valve 440 is opened to initiate a flow of halogen through tubing 436 and through metering nozzle 438 into the swivel joint inlet 426 of the reel 412. The metering orifice of halogen nozzle 438 is sized to meter the halogen at storage pressure into the extinguishing liquid at a rate of 0.060 lbs. per gallon of liquid per minute. When the nozzleman opens the nozzle, a stream of foam will be projected therefrom. It will be appreciated that in the FIG. 5 embodiment, the halogen nozzle 438 can be positioned in other locations in the hose line system such as at a hose coupling or even at the nozzle end itself. If required thereby, the tubing 436 can be of the flexible type such that the mobility of the installation is not unduly restricted. Although shown and described in what are believed to be the most practical and preferred embodiments, it is apparent that departures from the specific methods and apparatus described will suggest themselves to those skilled in the art and may be made without departing from the spirit and scope of the invention. I, therefore, do not wish to restrict myself to the particular instrumentalities illustrated and described, but desire to avail myself of all modifications that may fall within the compass of the appended claims.

1a

TECHNICAL FIELD OF THE INVENTION [0001] The present method and composition relate to appetite suppressants. Particularly, the present composition and method relate to an all-natural appetite suppressant. BACKGROUND OF THE INVENTION [0002] Whether trying to shed a few extra pounds or the effects of a lifetime of over-indulging and poor eating habits, diet and exercise are key elements of any successful program. However, some people can be easily discouraged by lapses or a lack of self-discipline making long-term weight loss changes a seemingly insurmountable burden. [0003] Accordingly, many dieters have turned to using nutritional supplements to help stay hunger pangs and increase their chances of long-term success. One relatively recent entry to the field is known as Hoodia Gordonii. [0004] Hoodia, pronounced “who-DEE-ah,” Gordonii is a leafless spiny succulent plant with fleshy finger like stems and is also known as “Xhoba.” Technically speaking, it is different from a cactus. Hoodia Gordonii grows naturally in the harsh desert conditions of the Kalahari Desert of Southern Africa. It has also been cultivated in semi-arid areas of China, Mexico and the United States with limited success. The plant grows to a mature height of six-feet and may survive for as much as a century or more. The Hoodia plant belongs in the succulent family of Asclepiadaceous, along with about 20 other species including statelier, stephanotis and vinca. [0005] As Hoodia grows, it forms multi-stemmed clumps 12 inches wide by 12 inches high and bears 3-4 inch diameter unpleasant-smelling, pale, purple, saucer-shaped flowers. Row of thorns are present along the stems. [0006] It is said that the San people of the Kalahari have learned to eat the bitter-tasting plant to suppress their appetite and thirst when on long hunting expeditions. By taking the edge off appetite and thirst, the hunters are able to respect their tradition of bringing home their entire catch without eating of it on the return trip. [0007] Hoodia is registered as a protected species by the South African Nature Conservation and farmers are granted a special permit allowing Hoodia to be commercially grown and harvested for sale to the consumer market. Hoodia takes two years to grow and is now being grown in sustainable quantities by South African farmers. It has become widely known as one of the greatest appetite suppressant of all time. SUMMARY OF THE INVENTION [0008] There is disclosed herein an improved appetite suppressant which avoids the disadvantages of prior compositions and methods while affording additional benefits and advantages. [0009] In one embodiment of a composition for suppressing appetite, the invention includes Guarana extract 36%, Hoodia 20:1, Cha de Bugre 4:1, Ginseng, Citrus Auratium, Magnolia bark extract, and black pepper. The composition contains an amount of Guarana extract 36% within the range of from about 40% to about 70% by weight. The composition contains an amount of Hoodia 20:1 within the range of from about 12% to about 30% by weight. The composition contains an amount of Cha de Bugre 4:1 within the range of from about 5% to about 25% by weight. The composition contains an amount of Ginseng within the range of from about 2.0% to about 8.0% by weight. The composition contains an amount of Citrus Auratium within the range of from about 2.0% to about 8.0% by weight. The composition contains an amount of Magnolia bark extract within the range of from about 2.0% to about 8.0% by weight. The composition contains an amount of black pepper within the range of from about 2.0% to about 8.0% by weight. [0010] In a disclosed method for body weight reduction, an embodiment of the invention includes orally administering to a person a dosage comprising Hoodia 20:1 in an amount within the range of from about 69 to about 170 mg. The dosage may include any or all of Guarana extract, in an amount within the range of from about 230 to about 405 mg, Cha de Bugre 4:1, in an amount within the range of from about 28 to about 145 mg, and Ginseng, Citrus Auratium, Magnolia bark extract, and black pepper, each in an amount within the range of from about 11 to about 46 mg. The total dosage is within the range of from about 300 to about 700 mg, preferably about 575 mg. [0011] These and other embodiments of the invention may be understood more readily from the following detailed description. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0012] While this invention is susceptible of embodiments in many different forms, there is described in detail herein a preferred embodiment of the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to embodiments described. [0013] The disclosed composition contains an effective amount of Hoodia Gordonii combined with several other ingredients. It is believed that the combination of these additional ingredients creates a synergy in the efficacy of the Hoodia. That is, the additional ingredients are believed to permit the use of less Hoodia in the total composition to achieve the same appetite suppressant success as that of a larger dosage of pure Hoodia. [0014] The additional ingredients used in the embodiments of the present composition are as follows: Guarana Extract [0015] Guarana comes from the Amazon rainforest and is used to improve mental sharpness, reduce fatigue, increase stamina and endurance, and may even lift depressed spirits. [0016] Guarana is a shrubby, climbing vine that is native to South America, with compound leaves, yellow-flowered panicles, and pear-shaped fruit, filled with seeds like a small horse chestnut. It thrives in moist, humus-rich soil in the partial shade of the rainforest at a minimum temperature of sixty-five degrees Fahrenheit. Guarana is made by the Guaranis, a tribe of South American Indians, in a long and complicated process. The seeds are shelled, washed, roasted, and pounded into a fine powder that is mixed with water to make dough. [0017] The dough is then rolled and sun-dried (or over a slow fire) until it hardens and is cut into cylindrical pieces. The result is a bitter, chocolate-flavored substance (without chocolate's oiliness) that is used in refreshing teas or as a tasty, coffee-like drink that is said to increase energy and mental acuity, combat fatigue and promote endurance and stamina. Guarana is said to be the richest source of caffeine worldwide, well-known for its stimulating effects due to that high caffeine content. [0018] Some of the constituents in Guarana include adenine, caffeine, D-catechin, saponin, tannins, theobromine, theophylline, starch and a fixed oil, and a crystallizable principle in the seeds called guaranine. [0019] Guarana is a stimulating tonic that is believed to improve physical stamina and endurance. Because guaranine is almost identical to caffeine in its actions, athletes have been known to take it to stimulate and improve their performance and increase their strength and endurance. It is also thought to reduce fatigue and exhaustion. The combination of guarinine, theobromine and theophyline act to stimulate the central nervous system and also act to enhance the metabolic rate, which may be helpful in weight loss programs. [0020] As a “nervine,” Guarana is also said to strengthen functional activity of the nervous system. The alkaloids theobromine, and theophylline act to stimulate the central nervous system and are thought to be useful in cases of neuralgia, paralysis, migraine and nervous headache and the distress that sometimes accompanies menstruation. [0021] Guarana is considered a gentle excitant that is said to be good for depression and mental exertion where there is fatigue or even exhaustion from hot weather. It is also thought to increase mental sharpness and concentration, which may also be a result of its guarinine content. [0022] The tannins in Guarana act as an astringent and are said to help ease mild forms of leucorrhoea (vaginal discharge) and diarrhea. As a mild diuretic, Guarana is thought to promote urine flow and act as febrifuge that helps to reduce mild fevers. It is also said to alleviate urinary tract irritation. Cha De Bugre [0023] Chá de bugre ( Cordia salicifolia —Brazil, Cordia ecalyculata -Paraguay) is a small tree growing 8-12 meters in height with a trunk 30-40 cm in diameter. It is indigenous to Brazil and can be found growing predominately in the Brazilian states of Minas Gerais, Bahia, Acre and Goias. It is also found in tropical forest areas of Argentina and Paraguay. In Brazil, it is commonly called café do mato (coffee of the woods) because it produces a red fruit resembling a coffee bean which is roasted and brewed into tea as a coffee substitute. [0024] Chá de bugre products are highly commercialized as a weight loss aid in Brazil where tea bags, fluid extracts and tinctures of chá de bugre are commonly seen in pharmacies, stores, and even in the beach-front eateries and refreshment stands along Rio de Janeiro's beaches. It has long been a popular weight loss product which has been marketed as a diuretic, appetite suppressant, and believed to help prevent or reduce fatty deposits and cellulite. Dr. C. L. Cruz in his book, Dictionary of the Plants Used in Brazil , recommends chá de bugre as an excellent diuretic and weight loss aid as well as a good general heart tonic which can help stimulate circulation. It is also used in Brazil and Haiti as a tea to help relieve coughs, regulate renal function, reduce uric acid and, used externally, to heal wounds. [0025] Despite the popularity of chá de bugre in Brazil very little has been done to analyze the phytochemicals in the plant. At present it is known to contain caffeine, potassium, allantoin and allantoic acid. The red fruits or berries of chá de bugre (resembling a coffee bean) contain caffeine. The allantoin and allantoic acid may explain the traditional use of the plant for wound healing. Main plant chemicals include allantoin, allantoic acid, caffeine, potassium. [0026] Very little clinical research is thought to exist on chá de bugre. However, some possible uses for chá de bugre include reducing herpes virus penetration, inhibition of cancer cells, and a as a heart tonic. [0027] As an appetite suppressant, rather than cutting off appetite all together (then causing intense hunger when it wears off at the wrong time) chá de bugre gives one a sense of being full and satiated after eating only a few bites of food. This seems to promote much smaller meals, more often, which is what many practitioners believe is better for sustained weight loss and keeping the metabolism going throughout the day. Ginseng [0028] The use of Ginseng is thought to be an excellent way to improve the body's resistance to infection and damaging environmental influences. It is also used by many athletes for overall body strengthening and endurance. Ginseng has been used for treatment of bronchitis, circulatory problems, diabetes and infertility. Some believe it may even be helpful in lowering cholesterol and possibly even inhibiting the growth of tumors. It has long been used as an aphrodisiac and is especially helpful to weak or elderly people. [0029] American Ginseng is a smaller version of its more famous Asian (Korean/Chinese) cousin but has many of the same benefits. It is a slow-growing perennial plant with a large fleshy root (the part used in herbal medicine) and a stem that grows to two feet. It is found from Maine to Georgia and from Oklahoma to Minnesota, and it is endangered in much of this area. [0030] Generally speaking, Ginseng normalizes body functions during stressful situations which tend to alter those functions. This “normalization” helps the body to adapt and return to an overall sense of well-being. It also improves mental and physical vigor and is used by athletes for overall body strengthening and endurance. [0031] Ginseng helps to combat stress because it appears to protect a portion of the brain known as the hippocampus from the effects of stress hormones. This prevents memory problems and loss of cognitive ability in people who suffer from bipolar disorder and even depression. It may be used to relieve fatigue, stress and nervousness, especially after acute illness. [0032] Ginseng is believed to promote a good appetite, stimulate fertility in women, and is helpful for rheumatism, headaches, colds, coughs, bronchitis, constipation, cystitis and symptoms of menopause. It has anti-inflammatory properties which may be useful in reducing fevers and lung problems. Taken in low doses, it acts as a mild sedative; in large doses, it acts as a stimulant. [0033] It has been used to reduce cholesterol, high blood pressure, and may be useful to inhibit the growth of cancerous tumors. Researchers also believe that it may be a viable alternative to conventional forms of treatment for Type-2 diabetes. [0034] Ginseng is said to increase vitality and improve the body's resistance to a wide variety of illnesses and damaging external influences. It strengthens the adrenal and reproductive glands, enhances immune functions and promotes lung and respiratory health. Citrus Aurantium [0035] Citrus Aurantium, a fruit commonly known as bitter orange, has been used in traditional Chinese medicine to treat chest congestion and indigestion, stimulate gastrointestinal function and improve circulation and liver function. In traditional western medicine, Citrus Aurantium has been used to treat digestive and circulatory problems. [0036] Citrus Aurantium is widely used for stimulating the breakdown of fat, by causing the release of noradrenaline (a stress hormone) at beta-3 receptor sites creating chemical reactions that increase fat breakdown. Beta-3 receptors in the body increase the rate at which fat is released from the body stores (lipolysis) and increase resting metabolic rate (thermogenesis). Physical activity tends to increase this thermogenic effect and further enhances the thermogenic effect of Citrus Aurantium towards healthy and permanent weight loss. Magnolia Bark Extract [0037] In Chinese medicine Magnolia Bark has been associated with the stomach, lungs, spleen, and large intestine for over two thousand years and has been used to treat abdominal bloating, gas, nausea, diarrhea, menstrual cramps, and indigestion. Recent studies have found that the herb inhibits the production of cortisol (the substance that encourages fat storage) and may be effective in weight loss programs. [0038] Magnolia is a magnificent family of forest trees that are revered for their beautiful, large, showy, and fragrant flowers. Magnolias may be both evergreen and deciduous with luxuriant foliage and rich flowers and can reach a height of more than eighty feet, with some species much smaller. Magnolias can survive in both moist and dry soils that can be neutral-to-acid-to-alkaline, in sun or partial shade with shelter from cold winds and late frosts. When growing in warmer climates, the trees reach their greatest development. [0039] Magnolia Bark is collected in the autumn, and the unopened flowers are harvested in the springtime and used in herbal medicines. Some of the constituents in Magnolia Bark include volatile oils (eudesmol, bornyl-acetate, etc.), alkaloids, tannin, magnolol, honokiol, zinc, copper, calcium, potassium, iron, magnesium, and manganese. [0040] Magnolia Bark has been used in Chinese herbal medicine for at least two thousand years as an aromatic, pungent, and warming stimulant that treats various disorders of the digestive system and strengthens stomach function. It is a bitter relaxant herb that acts as a tonic and improves digestion; relieves stomach pains, gastroenteritis, and flatulence; calms diarrhea and vomiting associated with indigestion; stimulates poor appetite; and alleviates fullness and distension of the abdomen. [0041] As a mild diaphoretic, Magnolia Bark is said to increase perspiration and sweating and thus reduce fevers and cool the body. It has been used in cases of malarial fevers and fevers of a typhoid type. [0042] Magnolia Bark is believed to have antiseptic, antibacterial, antifungal, antispasmodic, expectorant, and anti-inflammatory properties. As such, the bark is thought to relieve the pain and inflammation of rheumatism; counteract yeast infections (such as leukhorrea); combat upper respiratory tract infections and spasms, such as asthma, coughs, profuse phlegm in the lungs, shortness of breath, and fullness and pressure in the chest area. [0043] In the fight against obesity and weight management, Magnolia Bark has recently been recognized as an efficient fat burner. It is said that the magnolol and honokial in the herb effectively inhibit the body's production of cortisol, the substance that liberates fat from adipose cells and thus suppresses fat storage, particularly in the abdominal and belly area. Black Pepper [0044] Black pepper has been used for years as a stimulant for taste. Use in the present composition is to give the user a warm and biting reaction to taking the capsule. It is not intended to produce dietary results, only the feeling that something good is happening. Obviously, other taste stimulators known by those skilled in the art may be used to provide the same or similar sensation. [0045] Given these components, a dosage of between about 300 and 700 mg, preferably about 575 mg, using varied amounts of each within specified ranges can be composed to offer various synergistic effects. The formula ranges shown in TABLE 1 are general weight loss formulas for obtaining the benefits of each component while still avoiding the potential side effects of having too much of any one component. [0000] TABLE 1 300–700 mg Dosage 575 mg Preferred Dosage Percent Weight Preferred Preferred (%) (mg) Percent (%) Weight COMPONENT by Weight Range by Weight (mg) Hoodia 20:1 12–30  69–173 17.3 100 Guarana Extract 36% 40–70 230–405 47.8 275 Cha De Bugre 4:1  5–25  28–145 17.3 100 Ginseng 2–8 11–46 4.3 25 Citrus Aurantium 2–8 11–46 4.3 25 Magnolia Bark 2–8 11–46 4.3 25 Black Pepper 2–8 11–46 4.3 25 [0046] Note that the “Preferred Percent (%) by Weight” column only totals 99.6%. The non-active ingredients used to prepare the dosage form, such as Magnesium stearate which is widely used as a lubricant in the manufacture of pharmaceutical solid dosage forms, have not been accounted for. Those skilled in the art would understand the use of such ingredients to produce the desired dosage form. [0047] To suppress appetite, the preferred dosage of 575 mg should be administered to the individual twice daily, once in the morning (at least one hour before breakfast) and once in the afternoon (at least one hour before dinner) being the preferred dosage schedule. The total dosage may be within the range of from about 300 mg to about 700 mg, with the daily dosing being adjusted accordingly. That is, if using smaller dosages, e.g., 300 mg tablets, then in some cases it may be desirable to administer two tablets (i.e., 600 mg total) at each of the prescribed times. [0048] The matter set forth in the foregoing description is offered by way of illustration only and not as a limitation. While particular embodiments have been described, it will be apparent to those skilled in the art that changes and modifications may be made without departing from the broader aspects of applicants' contribution. The actual scope of the protection sought is intended to be defined in the following claims when viewed in their proper perspective based on the prior art.

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BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to surgical instruments and more particularly to a thermoelectric cryosurgery tool and a method of using the same. 2. Description of the Prior Art Cryosurgery, which relates to the destruction of living tissue by freezing cells, is commonly used to destroy benign and malignant tumors or neoplasms of the skin and mucous membranes. For example, cryosurgery is a commonly used treatment for warts, sun damage, keratoses, liver spots, and basal cell carcinoma. Modified cryosurgery has also been used to treat inflammatory diseases of the skin, including acne. Cryotherapy has been used in nerve disorders such as the management of chronic pain and the heart disfunction AV-Node Reentrant tachycardia. Cryosurgery has also been effective in the ocular fields for open angle glaucoma treatment, cataract, and lens removal. Cryosurgery is preferred to scalpel surgery for the treatment of many lesions because it is quick, rather painless, and often does not require local anesthesia, has a very low risk of infection post-operatively, and generally leaves a more cosmetically acceptable scar, if any. Cryosurgery is preferred to electrosurgery for the treatment of these lesions because the scar is cosmetically more acceptable and the depth of tissue destruction is greater. The mechanisms, identified in the literature, causing cell destruction during cryosurgery, are several. First, if the cells are cooled slowly water leaves the cell resulting in high concentrations of toxic electrolytes which necritize. Second, if the rate of freeze is carried out too quickly, the ice crystals formed are small and less damage producing. During the thaw, if the "ice to water" phase change occurs too quickly, all ice simply melts. If thaw rates are slow, the ice crystals elongate as smaller crystals melt and refreeze to their neighbors, causing cell wall rupture. Lastly, cell death occurs when metabolism continues while ice blocks cell nutrient supply and waste disposal. Cryosurgery may be performed through the direct application of refrigerants, such as dry ice, liquid nitrogen, nitrous oxide, or chlorofluorocarbons (CFC's) to the tissue at the treatment site. Methods of application include direct spray to the tissue, dipping a cotton swab into the liquid cryogen and then applying the soaked swab to the site or spraying the cryogen into a closed tip metal tube which is in contact with the site. However these techniques are undesirable for several reasons. First, the direct application of cryogens, dip or spray, causes a very fast freeze, resulting in the creation of tiny ice crystals instead of the large damage producing type. The cells also do not have time to dehydrate, reducing the damage caused by high electrolyte concentrations. After the cryogen is removed the heat from inside the body causes a relatively fast thaw, reducing the further elongation of ice crystals during the "ice to water" phase change, which occurs during a slower thaw rate. The application of spray into a closed tube gives some temperature rate control, but with great difficulty and imprecise cycle reproducibility. Second, some methods use CFC's which are hazardous to the environment, while others use nitrous oxide which can be toxic to the patient and physician. Thirdly, the literature states that many times the above treatments are not 100% effective due to the inability to induce enough of the mechanisms of destruction and the patient must return for successive treatments at later dates. Fourth, the technique requires the purchase and storage of expensive, volatile refrigerants which quickly evaporate, no matter how well they are insulated. In addition, the direct use of refrigerants may expose the patient to the potential risk of cryoinjury resulting from refrigerant run-off or over-spray. Contamination of the refrigerant supply has also proved to be a drawback. Due to the expense, evaporation, and storage difficulties, general practitioners, small clinics, hospitals, military field hospitals, and underdeveloped countries do not normally keep cryogenic materials on hand, but refer their patients to a specialist, which causes greater inconvenience and cost to the patient. It has been proposed to confine the refrigerant within a hollow cryoprobe. A cryoprobe typically includes a metal tip and a thermally insulated handle for holding a supply of the refrigerant. However, these probes also suffer from the storage and evaporation problems associated with the direct application of the refrigerants. Beginning in approximately the 1960's, thermoelectric cryoprobes based on the Peltier effect of thermoelectric cooling were introduced. These probes utilized thermoelectric heat pumps, constructed from junctions of opposing P-type and N-type semiconductors. When an electric current is passed through the junction, the resulting electron flow pumps heat from the cold junction to the hot junction of the heat pump. A cascade of such devices, each cooling the hot junction of its neighbor, can reach cryogenic temperatures electrically, eliminating the need to store and apply dry or liquid refrigerants. Examples of thermoelectric cryoprobes includes U.S. Pat. No. 3,502,080/Re26,276 (Hirschhorn), U.S. Pat. No. 3,369,549 (Armao) and U.S. Pat. No. 4,519,389 (Gudkin et al.). Gudkin et al. discloses a semiconductor thermoelectric element mounted on a handle. The Hirschhorn reference discloses a hand-held surgical instrument having a cutting edge or tool connected to a metal rod. The metal rod in turn is in direct physical contact with a plurality of Peltier elements, allowing the cutting edge or tool to be cooled considerably below ambient room temperature. The Armao reference discloses a probe containing several thermoelectric elements capable of delivering either cryogenic or thermal temperatures for the treatment of tissue. Typically, prior art devices have relied on solid metal thermal conductors and have operated the thermoelectric modules in parallel to increase the heat flow to the desired level. Configurations of this type are usually limited to a maximum temperature differential on the order of 65° C. The use of solid conductors also degrades performance because of the high temperature gradients supported by solid metallic conductors. A one-inch long copper or silver conductor is not suitable for cryosurgery, even if side losses are ignored, because of its high thermal resistance. A heat pipe is a heat transfer device, usually tubular in shape, which is completely self contained, and has no moving mechanical parts. In general, cryogenic heat pipes are vacuum insulated. Cryogenic pipes have a condenser end which is cooled, causing the gas to condense. The condensed liquid is absorbed by a wick and flows by capillary action to the evaporator end. As heat is applied to the evaporator end, some of the liquid evaporates. This gas travels through the hollow center at near sonic speeds to the cooled, condenser end where it gives up heat, recondenses and starts the cycle again through the wick. Heat pipes are useful since they assume a nearly isothermal condition while transporting large quantities of heat. Thus, heat pipes can transfer several hundred times the amount of heat that is transferred by metallic conductors at the same temperature drop. A properly designed heat pipe requires as little as one thousandth the temperature differential needed by a copper rod to transmit a given amount of power between two points. In addition, heat pipes have the ability to regulate heat-flux transformation. As long as the total heat flow is in equilibrium, the fluid streams connecting the condenser and evaporator ends essentially are unaffected by the local heat flux in these regions. In fact, heat pipes which are two feet long lose only a couple of degrees from one end of the pipe to the other. A high heat flux input at one point of the evaporator end can be coupled with a large area of lower heat flux in the condenser end. The direct application of liquid refrigerants is very effective because the physical evaporation of cryogens achieves a great flux density. The vaporization of cryogens in a heat pipe evaporator works the same without loss to the atmosphere. Heat pipe models featuring flow through a closed end tube are nearly as effective as the above-described cryoprobe, with only a small thermal resistance at the end of the tube. Cascades of Peltier devices are also known in the art. For example, An Instrument Using a Multiple Layer Peltier Device to Change Skin Temperature Rapidly, published in Brain Research Bulletin, Vol. 12, 1984, teaches a three layer Peltier device utilized in a pain research application. The device incorporates proportional feed back control to provide stable temperatures within the treated tissue. None of the prior art Peltier instruments, including Frigitronics, are able to achieve temperatures lower than -25° to -35° C. SUMMARY OF THE INVENTION In contrast to this prior art, the present invention provides a handheld cryoprobe which includes a heat pipe structure coupled to a series cascade of several thermoelectric modules to provide a cryogenic heat sink. This cryogenic heat sink is connected to a treatment tip through the use of a heat pipe. Two configurations are contemplated. In the first embodiment, the cascade of thermoelectric devices is coupled directly to the treatment tip via the heat pipe structure. In the second embodiment, the cascade of thermoelectric devices is coupled to the treatment site through a heat pipe which carries an additional thermoelectric cooling module which may be bifurcated at its distal end. Although voltage polarity may be reversed to the tip module, creating a heating mode, this auxiliary thermoelectric element is referred to as a tip cooler throughout. When in a cooling mode, the tip module acts as an additional series fed refrigerating stage. In either arrangement, each thermoelectric device in the cascade cools its neighbor, thus generating a steep temperature gradient. This cold source/heat sink is coupled to the heat pipe which connects to a replaceable distal probe tip. The quick start up of the heat pipe permits the probe to improve the cooling rate in the tissue at the treatment site, which materially aids in the destruction of tissue, and significantly reduces the time required in surgery. The structure of the present invention also includes a heat exchanger coupled to the cascaded thermoelectric cooling modules to reject heat from the application site into the air. In operation, the distal end of the heat pipe is fitted with a disposable probe tip which is configured to meet the requirement of the specific surgical procedure. Alternatively, the tip itself may be configured as a heat pipe in order to avoid the thermal resistance of solid metal. This device is capable of administering sustained cryogenic temperatures of approximately -60° to -70° C. to tissue proximate the distal probe tip, although temperatures of about -10° to -25° C. are sufficient in most cases. Probes and thermoelectric modules which are vacuum insulated are preferred when cryogenic temperatures below -60° C. are desired. The thermoelectric coolers within the cryoprobe are regulated by a control system which may be programmed to cycle the power supplied to the thermoelectric modules to generate multiple freeze-thaw cycles with multiple controlled ramp rates within the tissue at the treatment site. Although several treatment protocols may be practiced with the cryoprobe, the preferred treatment method involves multiple freeze-thaw cycles. In this application, the probe is operated to first form a frozen bolus of tissue at the treatment site. The tip cooler or primary cooler is then cycled to selectively thaw the center of the bolus and then refreeze the tissue periodically. This process leaves the exterior of the bolus frozen to protect outlying tissue. In operation, the probe may be used to form a bolus of frozen tissue. The bolus may then be selectively thawed by reduction of cooling power supplied to the probe. In this mode of operation, the outer wall of the bolus remains substantially frozen and thus insulates the surrounding tissue from the cryogenic temperatures. This method of operation permits highly localized and selective destruction of tissue. When a heat pipe without a tip thermoelectric module is utilized, the center of the tip may contain a resistance heater to effect thaw in the thaw procedure. The selective destruction of tissue relies on several interrelated factors. For example, the outer wall of the frozen bolus prevents transport of nutrients and removal of metabolic waste products from the bolus, while the frozen barrier acts as a thermal insulator to localize and confine tissue destruction to the bolus volume. In addition, during the controlled rate thaw at the ice/water phase change, elongation of ice crystal growth is induced, causing mechanical damage to the cells. BRIEF DESCRIPTION OF THE DRAWINGS In the Drawings, like reference numerals indicate corresponding structure throughout the several views of the illustrative embodiment of the invention, in which: FIG. 1 is a schematic diagram of the major elements of a first embodiment of the combination; FIG. 2 is a schematic diagram of the major elements of a second embodiment of the combination including a tip cooler; FIG. 2A is a cross-section view of a thermoelectric tip cooler module; FIG. 3 is a schematic diagram of the major elements of a modified version of the second embodiment of the combination which includes a tip cooler having concentric cooling and heating zones; FIG. 4 is an illustration of the ice bolus formed by application of a conventional cryoprobe using compressed gas sprayed on the inside of the tip; FIG. 4A is an illustration of the ice bolus formed by application of a heat pipe cryoprobe cooled thermoelectrically; FIG. 5 is an illustration of the ice bolus formed by cycled application of the cryoprobe having a bifurcated thermoelectric tip assembly; FIG. 5A is an illustration of the ice bolus formed by cycled application of a heat pipe having a resistance heater; FIG. 6 is a temperature-time history diagram illustrating a rapid phase change during the freeze/thaw cycle provided in accordance with state of the art procedures using liquid cryogens; FIG. 6A is a temperature-time history diagram illustrating the extended phase change cycling provided in accordance with the principles of the present invention; FIG. 7 is a temperature-time history diagram illustrating the multiple freeze thaw cycling provided in accordance with the principles of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A schematic representation of the handheld electronic cryoprobe 10 is shown in FIG. 1. Cryoprobe 10 is used in conjunction with a disposable application or probe tip 12. Probe tip 12 can be of varying sizes, shapes and lengths, and has a biocompatible treatment surface in thermal contact with the distal end 17 of heat pipe 16. A handle 14 is provided to facilitate use of probe 10 by the physician. In general, cryoprobe 10 is reusable, since tip 12 is the only component which is disposable. In general, probe 10 may include a number of different handle and tip configurations to tailor the probe to a particular surgical procedure and/or the preference of a particular physician. For this reason, tip 12 and handle 14 are shown in schematic form. The disposable probe tip 12 can contain thermoelectric and/or heat pipe materials, and is used as a trim cooler/heater to give fine temperature or control during the surgical procedure. A sterile sleeve (not shown) can be attached in the configuration so that it will slide over the heat pipe extension when installed. A quick snap-on connection (not shown) automatically makes power and thermocouple leads. Heat pipe extensions can also be quick-connected to the main power thermoelectrics in the handle (not shown), and contain power and thermocouple extension wiring for controlling the tip 12. The proximal end 19 of heat pipe 16 is attached to Peltier effect thermoelectric cooling modules 18. Proximal cooling modules 18 draw heat from tip 12 and rejects it into a heat exchanger system depicted at 20. A liquid coolant such as tap or chilled water may be circulated through appropriate tubing 22, 23 to transfer heat from cryoprobe 10 to the remote heat exchanger 20 which in turn rejects the heat into the environment. Tubing 22, 23 may be made, for instance, of any well known plastic material, and may be insulated. Alternatively, to get the heat from the thermoelectrics in handle 14 to the remote heat exchanger 20, it is possible to use a circulating liquid system where supply and return liquid channels and wiring are contained within one tube (not shown). This tube will have a closed cell insulation extruded over the channels, with an outer protective sheath, such as silicone. Heat pipe 16 is of a typical heat pipe construction known in the industry, as described above, having a closed thin wall tube with its inner wall covered with a capillary wick composed of several layers of fine material such as mesh screen, sintered metal wool, or powdered metal. Preferably, heat pipe 16 and thermoelectric modules 18 are vacuum insulated. Heat pipe 16 is evacuated and a volatile fluid, such as ammonia, is metered into the tube to a proper vapor pressure. Cryogenic heat pipe 16 has a condenser end 19 and an evaporator end 17. The condenser end 19 is cooled, and the gas condenses. The condensed liquid is absorbed by the wick and flows via capillary action to the evaporator end 17. As heat is applied to the evaporator end 17, some of the liquid evaporates to a gaseous state. High efficiency is achieved through the phase change of the liquid to its gaseous state. This gas travels at near sonic speeds through the hollow center to the cooled condenser end 19 where it gives up its heat. The gas recondenses and starts the cycle again through the wick. Thus, the heat pipe is a closed cycle refrigerator which has no moving mechanical parts, and is powered externally by the thermoelectric materials. Thermoelectric cooling modules 18 are essentially a multi-stage thermoelectric heat pump assembly containing numerous cascaded N-type semiconductors and P-type semiconductors well known in the art. Electrons in the N-type semiconductors and holes in the P-type semiconductors move heat from the cool body to a heat sink where the heat is removed. A control unit 24 is provided to manage the power requirements of the system. Control unit 24 supplies power through a connection 26 to control the circulation of coolant in heat exchanger 20. Control unit 24 also provides electrical power to the proximal thermoelectric modules 18 through a connection 28. Control unit 24 may be programmed to cycle the power to the thermoelectric modules 18. Connection 26 and connection 28 can be any connection commonly used in the industry. In general, the amount of D.C. voltage supplied to thermoelectric modules 18 controls the heat transfer rate of the module because heat moves through the N and P-doped semiconductor relative to the current flow, which in turn varies with voltage application. In operation, feedback sensors may be located at the tissue treatment site to provide temperature information to control unit 24 which is used to cycle power to the thermoelectric modules 18. In the FIG. 1 embodiment, temperature feedback is provided from the treatment site by a remote sensor 13 which is integrated into disposable treatment tip 12. In general, one sensor 13 is sufficient on tip 12, although more may be utilized. Remote hypodermic thermocouple probes located in the tissue being frozen may also be used to provide the temperature feedback information. As shown in FIG. 1, temperature data from the treatment site is supplied to the control module 24 through a connection 15. Connection 15 can be any connection commonly used in the industry. With respect to the FIG. 1 embodiment, the temperature cycling of the tissue is accomplished by power regulation of proximal cooler 18, and is mediated by heat pipe 16 and the passive treatment tip 12. It should also be understood that a thermoelectric device itself can be operated as a temperature sensor. In embodiments where a distal Peltier effect thermoelectric tip cooler module 30, 30a is located proximate the treatment site, the thermoelectric tip module 30, 30a can be operated to provide temperature feedback information by their respective current flows, since current flow in thermoelectric materials is directly related to their temperature. This configuration is shown in the embodiment depicted in FIG. 2 and FIG. 3. FIG. 2A sets forth a cross-section view of thermoelectric tip cooler module 30. Tip module 30 is made of P and N semiconductor couples 50 positioned between voids 56 which are filled with a thermally conductive material, such as thermally conductive epoxy. Insulating ceramic 60, such as aluminum oxide, sandwiches the P and N couples 50 and the voids 56 filled with conductive material. With respect to the FIG. 2 or FIG. 3 embodiment, the battery of proximal thermoelectric modules 18 provides powerful cooling, reducing the temperature of the treatment site to that needed for the surgical procedure. At this point, a distal or thermoelectric tip cooler 30, 30a, powered by control unit 24, may selectively cool or heat the treatment site to provoke a designed or specified freeze/thaw cycle, thus promoting damage to the tissue by controlling the rate of water/ice or ice/water phase change. The distal or tip thermoelectric 30, 30a, which can work as a cooler or heater by switching the voltage polarity from the DC power supply, serves to fine tune the temperature at the treatment site into a very accurate range, or a designed freeze/thaw cycle. In addition, distal or thermoelectric tip 30, 30a is utilized to control the freeze/thaw rate. The apparatus shown in FIG. 3 includes a bifurcated thermoelectric tip module 30a having two concentric zones. Each zone is separately operated so it can be heated or cooled. When bifurcated thermoelectric module 30a has both zones in a cooling mode, an ice ball 36 will form, as shown in FIG. 5. Each of the zones may be operated separately so that the co-central zone 31 may be operated as a heater while the adjacent annulus 32 may be operated as a cooler, or vice versa, to freeze or thaw the tissue within ice bolus 36. In FIG. 2 and FIG. 3, proximal cascade thermoelectric module 18 is coupled to the treatment site through a heat pipe which connects to disposable thermoelectric tip module 30, 30a at the distal end 17 of heat pipe 16. Feedback information in FIG. 2 and FIG. 3 is supplied to control unit 24 by connection 15, as discussed above. The preferred treatment modality using the FIG. 1 or 2 apparatus is depicted in FIG. 4A. The preferred treatment modality using the FIG. 3 apparatus is depicted in FIG. 5. The preferred treatment modality using a heat pipe tip with a resistance heater is shown in FIG. 5A. The temperature-time history diagrams of FIGS. 6, 6A and 7 are applicable to, and may be generated by any of the above treatment modalities. FIG. 4 illustrates the existing procedure where a treatment probe tip 12 is in contact with tissue 34 surface at a treatment site. Compressed cryogen gas is sprayed on the inside of hollow probe tip 12. As probe tip 12 is placed in contact with the tissue 34 surface, the expanding cryogen gas cools probe tip 12 to the desired operating temperature, such that an ice ball 36 is formed at and below the surface of tissue 34. Ideally, probe tip 12 is positioned so that the ice ball or bolus 36 which forms includes or encompasses the target, abnormal tissue or lesion 38 and a small amount of normal tissue 34. After the cryoprobe 10 is removed, ice ball 36 begins to quickly thaw from the inside to the exterior. FIG. 4A illustrates heat pipe 16 with tip 12 in contact with the tissue 34 surface. As electricity is supplied to the proximal cooler 18, heat pipe 16 is lowered to operating temperatures of about -70° C. Tip 12 on heat pipe 16 is positioned on the surface of tissue 34. As the tissue temperature decreases, ice ball or bolus 36 forms, so as to surround and encompass the target, abnormal tissue 38 and a small amount of normal tissue 34. After heat pipe 16 power is reduced, ice ball 36 begins to slowly thaw from the interior to the exterior. Probe 10 is operated to selectively thaw that portion of ice bolus 36 which is adjacent probe tip 12. Selective thawing of bolus 36 is achieved by reduction of cooling power supplied to probe 10. The power level supplied to probe 10 can be varied to prevent ice bolus 36 from completely thawing. Temperature feedback can be used to control the delivery of power to the probe 10 to provide the alternating freeze and thaw cycles, or the power level can be preprogrammed to follow a preset power delivery protocol. FIG. 5 illustrates an ice ball 36 formed when the bifurcated thermoelectric tip cooler module 30a shown in FIG. 3 has both zones in the cooling mode. After the initial ice ball or bolus 36 is formed, the co-central zone 31 can be switched to a heating mode while keeping the adjacent annulus zone 32 in a cooling mode. By this technique, the target abnormal tissue or lesion 38 can be brought to a metabolizing temperature while the outer wall of bolus 36 remains substantially frozen. Target tissue 38, as it is warmed, comprises water and water metabolizing stored nutrients. Ice in ice ball 36 is approximately four times as heat conductive as the liquid water in tissue 38. Thus, the outer cooled zone 37 surrounding target tissue 38 maintains the nutrient blocking ice shield. Alternatively, as shown in FIG. 5A, a heat pipe 16 tip 12 can include a thin film heater 35 (made from an etched-foil resistive element laminated between layers of insulating film of the tip 12 such as Thermofoil™ manufactured by Minco Products, Inc.). Thin film heater 35 performs the same function as inner thermoelectric zone 31 shown in FIG. 5. Heat pipe conduction 39 performs the same function as outer thermoelectric zone 32 in FIG. 5. Thus, thin film heater 35 can be used in a heating mode while heat pipe conduction 39 remains in a cooling mode so that target, abnormal tissue 38 can be brought to a metabolizing temperature, while the outer wall of bolus 36 remains substantially frozen, insulating the surrounding tissue from nutrient supply. The apparatus of the present invention may also be used to provoke multiple freeze-thaw phase changes in the treated tissue which are generated by selectively regulating the voltage delivered to the thermoelectric cooling modules. Such regulation can be accomplished by selectively increasing and decreasing the voltage delivered to the thermoelectric cooling modules 30, 30a to cool the treated tissue, followed by reversing the polarity of the voltage delivered to the thermoelectric cooling modules 30, 30a to warm the treated tissue. It should be further understood that the freeze-thaw phase changes can be generated by regulating the voltage delivered to either one or both of the thermoelectric cooling modules 18, 30, 30a. In addition, the precise regulation of the phase changes may be accomplished through the use of a control and temperature sensor feedback system, where an embedded hypodermic thermocouple transmits temperature information to a microprocessor which monitors the rate of temperature change relative to time, thus detecting the phase change. The microprocessor then applies power to the thermoelectric modules so as to extend the phase change time, thereby causing maximum ice crystal growth. This type of control is known commonly in industrial process control as PID (proportional, integral, derivative) control. Finally, when both thermoelectric modules 30/30a and proximal thermoelectric cooling modules 18 are utilized, freeze-thaw cycling may be accomplished by holding the thermoelectric cooling modules 30/30a at a constant, near-freezing temperature, while regulating the voltage delivered to the proximal cooling module 18. Multiple controlled ramp rates may be replaced in the above manner thus insuring complete tissue destruction in a single treatment. The time/temperature histories more fully describe this operation. In FIG. 6, the temperature profile 40 shows the temperature history of the surface being contacted by a liquid cryogen while profile 42 shows the temperature profile a short distance inside the tissue treatment site. At point A in profile 42, the tissue is at ambient temperature. The direct application of a liquid cryogen or hollow closed end tube being cooled by direct spray of a cryogen produces a steep drop in temperature in the tissue until it is removed as indicated at low point B. The tissue undergoes a natural thaw returning the temperature to ambient at point D. The inflection of the temperature time history at C, reflects the relatively rapid phase change from the solid to liquid phase. Some ice crystal elongation does develop during the thaw, normally not enough to assure effectiveness, for this reason normal procedures call for a second application after the thaw when treating cancer lesions. Additionally the freeze rate is so rapid that no phase change inflection can be detected during the temperature drop, thereby resulting in less damaging, very small ice crystals. These procedures depend on ice crystal growth solely during thaw to produce damage. In contrast to the direct application of liquid cryogens, FIG. 6A shows the time vs. temperature histories of the thermoelectrically powered probe. The temperature profile 40 shows the temperature history of the probe tip while 42 once again shows that temperature a short distance inside the tissue treatment site. At point A in profile 42, the tissue is at ambient temperature. The application of power to the thermoelectric modules 18 results in cooling the tissue below the freezing point, to a low temperature designated as B, in FIG. 6. The temperature drop is created by multi-stage thermoelectrics in the handle of the probe 10, and heat is extracted from the condenser end of the heat pipe. The evaporator end of heat pipe 16 is placed against target tissue 38 where it removes body heat at a rate shown by profile 42. At this point, the electrical power to the thermoelectric modules 18 is turned off or reduced, and tissue 38 undergoes a warming cycle, returning the temperature of the tissue to ambient at D. In general, this temperature vs. time history emulates the application of a prior art liquid refrigerant directly on the tissue as shown in FIG. 6. However, in contrast to the prior art, the rate at which the tissue is frozen is a feedback controlled function with an extended phase change induced during the freeze portion of the cycle. In a similar fashion the B to D transition can be controlled as well, and the phase change time during the thaw cycle can be extended. Control over the solid to liquid phase transition can be used to maximize the amount of tissue damage resulting from the ice crystal growth and elongation invoked by the controlled slow thaw cycle. Direct application of the thermoelectric modules can achieve temperatures in the range of -25° C. However, the addition of heat pipe 16 improves the ability of the surgeon to manipulate the cryoprobe device 10 and allows the use of the larger thermoelectric modules needed for the colder temperatures and proper depth of freeze. In addition, use of the heat pipe 16 provides a means to reach into cavities. Heat pipe 16 can also be made flexible by using many thin walled microbore tubes in its construction to provide the gas and liquid transport areas of the pipe between the condenser and evaporator tip. FIG. 7 is a graphical illustration of the preferred multiple freeze-thaw phase changes that occur in treated tissue over time as a result of cycled application of cryogenic temperatures when a thermoelectric application tip 30 is added to the electronic cryoprobe 10 of the present invention. In operation, the initial temperature of the tissue at A is at or above room temperature. The multistage thermoelectric module 18, attached to the heat pipe 16 condenser end, drops the temperature initially to a less cold level B. Thermoelectric tip 30, or 30a added to the cold end of heat pipe 16 is applied to the site being treated, and heat is extracted or added as required to accomplish the tissue freeze/thaw procedure, shown at B, C, D, E, F, G, H and I in FIG. 7. Very accurate and quick temperature changes can be pre-programmed using an embedded microprocessor to accomplish a positive procedure. With the coldest temperatures being generated at tip 30 or 30a, probe 10 may be inserted into more restricted and deeper cavities without the chance of damaging normal wall tissue. As can be appreciated, use of cryoprobe 10 using a bifurcated thermoelectric tip cooler module 30a creates an ice shield which prevents the flow of nutrients resulting from the thaw of tissue 38, thereby ensuring cell starvation. A hand-held cryoprobe 10 eliminates the need for compressed gases, while giving the physician positive control. In addition, because solid state electronics lends itself to miniaturization, cryosurgical devices will have many uses, including possible use with endoscopes. While the invention has been described in detail with particular reference to the drawings and illustrative embodiment, it should be understood that modifications will be effected within the spirit and scope of the invention.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of application Ser. No. 07/712,926, filed Jun. 7, 1991, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to the field of footwear, more particularly footwear having a tongue portion. 2. Description of the Prior Art There is disclosed in the prior art shoes which have a tongue portion made unitary with other sections of the shoe. For example, U.S. Pat. No. 1,691,219 to Winn discloses buckle overshoes wherein the tongue is a unitary extension of only the vamp portion of the shoe. U.S. Pat. No. 2,244,030 to Teehan discloses a shoe wherein the tongue is formed with the lining of one side of the shoe. However, since the tongue is unitary with the vamp, counter and quarter regions of the shoe, the tongue will have limited ability to best mold to the wearer's feet. U.S. Pat. No. 2,428,262 to Bunker discloses a shoe very similar to the overshoe of Winn, except that two elasticized panels are provided at the leading edge of the tongue. Little if any molding of this tongue would be expected to result from the design of this shoe. Shoes normally have a tongue portion stitched to, and underlying the front part of the shoe--the vamp. The tongue normally extends from the vamp under the lacing area of the shoe. The tongue is, initially, formed as a separate piece of material, and then is stitched to the vamp. There is thus a layering of material where the tongue is stitched to the vamp, and this can sometimes cause discomfort to the wearer. Also, because the tongue is only "hinged" at the frontal vamp portion, it can readily be displaced away from the lacing area. It is a major objective of this invention to eliminate the cost of the cutting, and the stitching, of the tongue inherent in the prior art manufacturer of shoes, to eliminate accidental displacement of the shoe tongue, and to achieve a greater comfort level by having the tongue integrally formed with other parts of the shoe; namely, the quarter, counter, or quarter and counter region of the shoe. BRIEF SUMMARY OF THE INVENTION This invention is directed to a novel shoe tongue construction wherein the tongue is made as an integral extension of preferably the heel portion of the shoe--the heel portion of the shoe being known in the art as the counter. The tongue may also be an integral extension of the quarter. The quarter is the area in the mid-portion of the shoe, immediately adjacent to the lacing lines, this quarter area lying between the vamp and the counter. Regardless of whether the tongue construction of this invention extends from the counter or the quarter, or from a portion of each such area, substantial stitching is avoided, and the tongue may be much more stably positioned in the shoe than if the tongue is attached only at the vamp section of the shoe. The tongue extends only from one side of the counter or quarter thereby initially leaving a free unattached opposite edge. In the preferred embodiment, the initially free unattached edge of the tongue is anchored to the sole of the shoe by means of an elasticized strip of material. The tongue, while being stably positioned along the longitudinal axis of the shoe is still free to move up or down with respect to the shoe sole, along the longitudinal axis of the shoe. The tongue construction thus provided provides greater comfort to the wearer of the shoe than do conventionally mounted tongue constructions because the tongue is integrally formed with either the counter or the quarter of the shoe rather than only being stitched to the vamp. This construction is also more economical to make because cutting and stitching requirements are reduced. BRIEF DESCRIPTION OF THE FIGURES This invention is described with reference to the following drawings: FIG. 1 is a top perspective view of a first embodiment of the novel tongue construction of this invention; FIG. 2 is a longitudinal cross-section taken along the line 2--2 of FIG. 1; FIG. 3 is a transverse cross-section taken along the line 3--3 of FIG. 1; FIG. 3a shows the tongue construction of this invention as an extension of the heel counter lining, and is shown isolated from the shoe proper; FIG. 4 is a top perspective view of a second embodiment of the novel tongue construction of this invention; FIG. 5 is a longitudinal cross-section taken along the line 5--5 of FIG. 4; FIG. 6 is a transverse cross-section taken along the line 6--6 of FIG. 4; FIG. 7 is a side elevational view of a third embodiment of the novel tongue construction of this invention; FIG. 8 is a top plan view of FIG. 7 taken along the line 8--8 of FIG. 7; FIG. 9 is a transverse cross-section taken along the line 8--8 of FIG. 8; FIG. 9a shows the tongue construction of this invention as an extension of the quarter section, and is shown isolated from the shoe proper; FIG. 10 is a top perspective view of a fourth embodiment of the novel tongue construction of this invention; FIG. 11 is a longitudinal cross-section taken along the line 11--11 of FIG. 10; FIG. 12 is a transverse cross-section taken along the line 12--12 of FIG. 10; FIG. 12a shows the tongue construction of this invention as an extension of the heel counter lining, and is shown isolated from the shoe proper; FIG. 13 is a side elevational view of a fifth embodiment of the novel tongue construction of this invention; FIG. 14 is a longitudinal cross-section taken along the line 14--14 of FIG. 13; FIG. 15 is a transverse cross-section taken along the line 15--15 of FIG. 13; and FIG. 16 shows the tongue construction of this invention as an extension of the heel outer lining, and is shown isolated from the shoe proper. DETAILED DESCRIPTION OF THE INVENTION A right shoe 10 is shown in FIG. 1 typically having a vamp area 12, a quarter area 14 and a counter area 16. The vamp area 12 is that area directly in front of the lacing area of the shoe and normally overlies the toes of a foot. The quarter area 14 normally overlaps the mid-portion of the foot in front of the ankle. The counter 16 normally surrounds the heel of the foot. The outer side of the shoe 10 is designated, generally, by the numeral 7 and the inner side by the numeral 8. (See FIG. 3). The counter 16 of the shoe is typically formed with an outer material, e.g. made of leather 19 and an inner soft, cushioned lining 20 of e.g. wool, DACRON® synthetic polyester fiber, or cotton. In the presently preferred embodiment of this invention, extending forwardly of the counter area 16 is a tongue 18. The tongue 18 is typically formed of an outer fabric cover material 18a, and a cushioned lining therefor 18b. The tongue 18 is an integral and/or unitary extension of the lining 20 of the heel counter, as best seen in FIGS. 3 and 3a. Thus, the tongue 18 extends forwardly of the heel counter area 16, and underlies the quarter section 14. The tongue 18 need not be stitched or otherwise attached at its leading edge 21, but can be stitched as its leading edge 21, if desired. The trailing edge of the tongue 22 lies just to the rear of the quarter section 14. The inner side or medial edge 23 of the tongue 18 (FIG. 2) is preferably flexibly anchored to the shoe 10 by means of an elasticized strip of fabric 25, attached to the sole 26 of the shoe in a conventional manner. Such construction permits the tongue 18 to be mounted stably along the longitudinal axis of the shoe, but still permits up-down movement along such axis. An adjustable sleeve or channel is thus provided by the elasticized strip 25 and tongue 18 which extends integrally from the heel counter lining 20, as best seen in FIGS. 3 and 3a, through which the wearer's foot may easily pass. When the tongue 18 is an integral extension of the heel counter lining 20, stitching normally required to affix the tongue to the vamp can be eliminated, if desired. At the same time, the comfort provided is superior to the normal tongue construction because of the integration of the tongue with the heel counter lining 20. Such construction enables the foot to be enveloped by the tongue construction resulting in more of a "glove fit," and without the layering of material necessarily required in stitching the tongue to the vamp in the normal tongue construction of the prior art. While the construction shown in FIGS. 1-3A is presently preferred, the inner edge 23 of tongue 18 need not be anchored by strip 25. An embodiment wherein the inner edge 23 of the tongue 18 is not anchored by an elasticized strip 25 is illustrated in FIGS. 10-12a and is described further below. A second embodiment of this invention is shown in FIGS. 4-6. The shoe 30 has vamp, counter, and quarter sections 32, 34, 36, respectively. These sections of the shoe are as above described with reference to FIGS. 1-3. In this embodiment, the tongue section 38 is a unitary extension of section 40, the lower edge 51 of which is anchored to sole 50, by conventional means, section 40 being placed in an area occupied by both counter and quarter areas of the shoe. The tongue 38 has a free unattached leading edge 42, a trailing edge 44 and an inner side or medial edge 46. The tongue 38 is provided with a fabric or leather covering 47, and is normally lined with a cushioned material 48 made of cotton or synthetic material. The inner side edge 46 of tongue 38 is preferably flexibly anchored to the sole 50 by an elasticized fabric or mesh strip 52, strip 52 being affixed to inner edge 46 and affixed to the sole 50 in a conventional manner. Such construction provides a flexible channel through which the wearer's foot can pass--as best seen in FIG. 6. Counter sections 54 and 56 carry lacing eyelets or D-rings 57 in a conventional manner. A third embodiment of this invention is shown in FIGS. 7-9A. The shoe 60 has vamp, quarter, and counter sections 62, 64 and 66 respectively, all affixed to sole 67 by conventional means. In this embodiment, the tongue section 68 is a unitary extension of sole-anchored quarter section 64. The tongue section 68 has a free unattached forward edge 72, a rear trailing edge 74, and an inner side edge 76 (See FIGS. 9 and 9A). The inner side 76 may be flexibly anchored to the sole by elasticized strip 78 (see FIG. 9). The lacing D-rings 81 are carried by upper quarter sections 80, 82, these upper sections (usually made of leather) overlying tongue 68. Upper sections 80, 82 are attached to lower support sections 84, 86 respectively, made usually of stiffer material than leather, sections 84, 86 being anchored to the sole 67 in a conventional manner. FIGS. 10-12a show a fourth embodiment wherein no elasticized strip is used to anchor the inner edge 23 of the tongue to the junction of the uppers and the sole. For convenience and clarity of presentation, the same reference numerals used to describe FIGS. 1-3a are applied to describe the features of FIGS. 10-12a, except that no elasticized strip of fabric is used to anchor the inner side or medial edge 23 of the tongue to the junction of the uppers and the sole. Although the shoe 10 is shown with its tongue 18 extending from the lateral side of the shoe, with its initially free edge 23 lying on the medial side of the shoe, the shoe can be constructed so that its tongue extends from the medial side of the shoe to the lateral side of the shoe. FIGS. 13-16 show a fifth embodiment of the shoe wherein the tongue 18 extends from the medial side of the heel counter, and its lateral edge is attached with an elasticized strip of fabric to the lateral edge of the shoe. This embodiment is identical in all other respects to the first embodiment of the shoe, which is depicted in FIGS. 1-3a, and whose reference numeral are applicable to FIGS. 13-16. It should be borne in mind that the drawings are not rendered in actual scale so that certain features of the invention can be brought out and depicted. The drawings and the foregoing description are not intended to represent the only form of the invention in regard to the details of this construction and manner of operation. In fact, it will be evident to one skilled in the art that modifications and variations may be made without departing from the spirit and scope of the invention. Although specific terms have been employed, they are intended in a generic and descriptive sense only and not for the purpose of limitation, the scope of the invention being delineated in the following claims.

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