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TECHNICAL FIELD [0001] The invention belongs to the field of medicine, specifically relates to a preparation method of compounds of general Formula A, and more specifically relates to the ester derivatives of 7-a-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl]-estra-1,3,5(10)-triene-3,17β-diol and preparation method thereof. BACKGROUND ART [0002] 7-α-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl]-estra-1,3,5(10)-triene-3,17β-diol, also referred to as fulvestrant, having a general Formula B, is a novel estrogen receptor blocking agent in the treatment of postmenopausal advanced breast cancer which fails to respond to anti-estrogen therapy and which is estrogen receptor positive. [0000] [0003] The most important feature of breast cancer is that its occurrence and development associates with the estrogen level and metabolism thereof in vivo. Studies have shown that estrogen receptor (ER) was found in tumor cells of many patients with breast cancer, and tumor growth was stimulated by estrogen. Thus, one of the main methods for treating breast cancer is reducing the concentration of estrogen or blocking the binding of estrogen to its receptor to inhibit the growth and reproduction of tumor cells. Fulvestrant can competitively binding to estrogen receptors, with affinity similar to estradiol; it can also block the receptors, inhibit the binding of estrogen, stimulate deformation of receptors, and reduce ER concentration to destroy tumor cells. Fulvestrant can down-regulate ER protein in human breast cancer cells, down-regulate ER in tumor cells, and minimize tumor growth. Since fulvestrant does not change the condition of existing tumor ER and does not affect the generation of new ER, the tumor continues to be “programmed” as ER positive. In this way, fulvestrant continues to have therapeutical effects. Its greatest advantage is that it does not have partial agonistic action and estrogen-like activity of common antiestrogen drugs. [0004] Currently, many commercial available preparations of fulvestrant use oil as an excipient for the following two reasons. On the one hand, fulvestrant, which is of poor stability and easy to degrade, is generally stored at −20, and should not be stored at room temperature for too long, otherwise its purity would be affected. Although the mechanism of its degradation is not clear, it is generally believed that the main reason for affecting its stability lies in the presence of —OH at positions C-3 and C-17. Meanwhile, the presence of —OH at 3- and 17-positions increases the polarity of drugs and the stimulation of drugs on the gastrointestinal tract, thus it can only be prepared into injection. [0005] On the other hand, like other steroids, fulvestrant, which is difficult to be formulated due to certain physical properties, is a molecule with high lipophilicity and extremely low water solubility of about 10 ng/mL. Its solubility is provided in U.S. Pat. No. 5,183,514 and CN1394141A (mg/mL, 25° C.) (water 0.001, peanut oil 0.45, sesame oil 0.58, castor oil 20, Migloyl 810 3.06, Migloyl 812 2.72, ethyl oleate 1.25, benzyl benzoate 6.15, isopropyl myristate 0.80, Span 85 3.79, ethanol>200, benzyl alcohol>200). It can be seen that, even in castor oil with the maximum solubility, it is impossible to provide a concentration of fulvestrant that meets clinical requirement for administration. Therefore, many fulvestrant preparations in the marketplace not only use oil as solvent, but also add other excipients, such as ethanol, benzyl benzoate, benzyl alcohol and the like, to facilitate solubilizing. In this way, it can be formulated into intramuscularly injectable injections with content not less than 45 mg/mL, which can maintain effective plasma concentration (2.5 ng/mL) for 2 weeks. However, the addition of such solvents may increase the risk of precipitation of the drug in the preparations and cause irritation at injection sites. [0006] Thus it can be seen that, the problem to be solved in prior art is how to make structural improvements to fulvestrant, especially to —OH at positions C-3 and C-17, so as to reduce irritation to human body and increase its lipophilicity, thereby making it more easily to be formulated into preparations for human use, while maintain its inhibition effect on cancer cell. SUMMARY OF INVENTION [0007] Therefore, one object of the present invention is to make improvement to —OH at C-3 and C-17 positions of fulvestrant structure, and esterify fulvestrant into ester (including carboxyl carbon) compounds having 2 to 22 carbon atoms at C-17 position and ester (including carboxyl carbon) compounds having 2 to 4 carbon atoms at C-3 position, so as to increase the drug stability and its solubility in lipophilic solvents. [0008] The object of the present invention is achieved by the following technical solutions: [0009] The present invention provides a compound of Formula A: [0000] [0010] wherein: [0011] substituent R′ is selected from H, alkanoyl or alkenoyl having 2 to 4 carbon atoms, [0012] substituent R is selected from H, alkanoyl or alkenoyl having 2 to 22 carbon atoms; [0013] preferably, [0014] substituent R′ is H, and substituent R is selected from alkanoyl or alkenoyl having 11 to 22 carbon atoms; [0015] preferably, [0016] said substituent R is selected from alkanoyl having 11 to 22 carbon atoms, preferably undecanoyl, hexadecanoyl, docosanoyl or 2-[(3′,3′)-dimethyl-1′-methyl]butyl-5-methyl-(7,7)-dimethyl-octanoyl; [0017] preferably, [0018] said substituent R is selected from alkenoyl containing 1 to 6 carbon-carbon double bonds and having 11 to 22 carbon atoms, wherein said carbon-carbon double bonds can either be distributed in the main chain, or in the branched chain; preferably, [0020] said substituent R is selected from undec-2-enoyl, eicosa-5,8,11,14,17-pentaenoyl and docosa-(4,7,10,13,16,19)-hexaenoyl; [0021] preferably, [0022] when substituent R′ is selected from alkanoyl having 2 to 4 carbon atoms, said alkanoyl is acetyl or butyryl; [0023] preferably, [0024] said substituent R is selected from alkanoyl or alkenoyl having 11 to 22 carbon atoms, preferably 2-[(3′,3′)-dimethyl-1′-methyl]butyl-5-methyl-(7,7)-dimethyl-octanoyl or undec-2-enoyl. [0025] Exemplarily, said compounds may have structures of the following formulae. The structural formulae of fulvestrant esters I-XI are shown below: [0000] [0026] Furthermore, the present invention provides a process for preparing the compounds described as above, said process comprises the steps of: [0027] a) acylating the —OH at C-17 position of compound of formula B: a compound of formula B is mixed with an alkaline reagent, an organic acid and a catalyst in a solvent at room temperature under stirring to form a reaction mixture, said reaction mixture is reacted to obtain a crude product of compound of Formula A with C-17 position acylated; [0000] [0028] b) purifying the crude product obtained in step a) to remove the by-product N,N-dicycloalkylurea and obtain a purified product of compound of Formula A with C-17 position acylated; [0029] when said substituent R′ in the compounds is not H, said process further comprises the steps of: [0030] c) acylating C-3 position of the purified product with C-17 position acylated obtained in step b): the purified product with C-17 position acylated obtained in step b) is mixed with an alkaline reagent, an organic acid and a catalyst in a solvent at room temperature under stirring to be reacted to obtain a crude product of compound of Formula A with C-17 and C-3 positions acylated; [0031] d) purifying the crude product obtained in step c) to obtain a purified product of compound of Formula A. [0032] Wherein, in step a), said alkaline reagent is selected from pyridine, 2-methylpyridine, 3-methylpyridine, 4-methylpyridine, 2-ethylpyridine, 3-ethylpyridine, 4-ethylpyridine, 5-ethylpyridine, 2-methyl-5-ethylpyridine, 2-dimethylaminopyridine, 4-dimethylaminopyridine, preferably 4-dimethylaminopyridine; said solvent is selected from methyl chloride, methylene chloride, chloroform; said catalyst is dehydrating agent, preferably N,N-dicyclohexylcarbodiimide; said organic acid is alkyl acid or alkenyl acid having 2 to 22 carbon atoms; in step b), said purifying comprises the step of dissolving the crude product obtained in step a) in tetrahydrofuran or ethyl acetate to form a solution, then settling the solution with n-hexane or mixed solvent of n-hexane-ethyl acetate, separating and purifying the settled solution by silica-gel column chromatography and/or neutral alumina adsorption; in step c), said alkaline reagent is selected from pyridine, 2-methylpyridine, 3-methylpyridine, 4-methylpyridine, 2-ethylpyridine, 3-ethylpyridine, 4-ethylpyridine, 5-ethylpyridine, 2-methyl-5-ethylpyridine, 2-dimethylaminopyridine, 4-dimethylaminopyridine, preferably 4-dimethylaminopyridine; said solvent is selected from tetrahydrofuran, ethyl acetate, preferably tetrahydrofuran; said catalyst is dehydrating agent, preferably N,N-dicyclohexylcarbodiimide; said organic acid is alkyl acid or alkenyl acid having 2 to 4 carbon atoms; in step d), said purifying is carried out by silica-gel column chromatography and ethanol elution, wherein mixed solvent of n-hexane-ethyl acetate is used for gradient elution in said silica-gel column chromatography, the volume ratio of n-hexane to ethyl acetate is 50:1-1:1, preferably 40:1/10:1/5:1 for gradient elution. [0033] Furthermore, the present invention provides a composition comprising a compound of Formula A described as above, wherein, said composition is an oiling agent, a fatty agent or a microsphere agent. [0034] Furthermore, the present invention also provides the use of a compound of Formula A described as above or a composition comprising a compound of Formula A for the manufacture of a medicament in the treatment of cancer; said medicament is preferably used to inhibit cancer cells with estrogen receptors, particularly preferably used to inhibit breast cancer cells. [0035] The present invention also provides a method for treating cancer, wherein said method comprises administering to a subject in need a therapeutically effective amount of a compound of Formula A described as above; said method is preferably used to inhibit cancer cells with estrogen receptors, particularly preferably used to inhibit breast cancer cells; [0036] preferably, said compound of Formula A is administered by injection. [0037] Exemplarily, after being formulated into oiling agent, the compound(s) according to the present invention is administered to nude mice bearing human breast cancer MCF-7 tumor by subcutaneous injection to study the tumor inhibition rate. The result showed that such derivatives have anticancer activity for treating breast cancer. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0038] Hereinafter, the present invention will be further described in detail in combination with specific embodiments. The examples given are only for illustration, but not for limiting the scope of the present invention. Synthesis Examples [0039] Although the alkaline reagent in the examples below is 4-dimethylaminopyridine, it is understood that agents such as pyridine, 2-methylpyridine, 3-methylpyridine, 4-methylpyridine, 2-ethylpyridine, 3-ethylpyridine, 4-ethylpyridine, 5-ethylpyridine, 2-methyl-5-ethylpyridine, 2-dimethylaminopyridine and the like can also be used in the examples below as alkaline reagents. Example 1 Synthesis and Structure Confirmation of Compound II [0040] 1) Reaction Treatment [0041] 5 g (8.25 mmol) fulvestrant was added into a 500 mL three-necked round-bottom flask and dissolved with 300 mL methylene chloride while stirring. Then, 0.137 g (1.1 mmol) 4-dimethylaminopyridine (DMAP), 2.155 g (8.41 mmol) palmitic acid and 1.672 g (8.23 mmol) N,N-dicyclohexylcarbodiimide (DCC) was added sequentially into said flask. After reacting at room temperature (e.g., 20±5) for 48 h, the reaction was stopped. [0042] 2) Post Process [0043] The reaction mixture was filtered to remove precipitated by-product N,N′-dicyclohexylurea (DCU). The filtrate was washed with saturated sodium bicarbonate solution, then washed with water to neutral, and then evaporated by rotary evaporator to remove methylene chloride. Colorless and clear colloidal liquid (8.8 g) was obtained, which was dissolved in an appropriate amount of ethyl acetate, froze in a refrigerator (e.g., the freezing temperature may be −15±3). A small amount of white solid precipitated was washed out and removed by filtration for 3 times. Then, the filtrate was evaporated by rotary evaporator to remove ethyl acetate, and colorless and clear colloidal liquid was obtained. The colorless and clear colloidal liquid was dissolved in a small amount of tetrahydrofuran, then the solution was added to n-hexane to form a large quantity of white solid, which was left to stand and filtrated; the filter cake was dissolved in the aforesaid tetrahydrofuran and settled in n-hexane for 3 times to give white powder product, which was pure Compound II. The product was dried in vacuum at 60 to give 1.5 g II (purity 99.88% as determined by HPLC, C18 column, mobile phase: 67% THF in water, flow rate: 1.0 mL/min, detection wavelength: 220 nm), and the molar yield was 22%. [0044] IR (cm −1 ): 3209, 2922, 2852, 1607, 1503, 1446, 1385, 1106, 1055, 1014, 982. [0045] 1 HNMR (500 MHz, CDCl3, ppm): 0.78 (s, 3H), 0.88 (t, 3H), 1.01-1.52 (t, 32H), 1.59-1.63 (t, 6H), 1.70-1.76 (t, 6H), 1.89-1.94 (t, 2H), 2.10-2.32 (t, 10H), 2.61-2.85 (t, 8H), 3.74 (t, 2H), 6.20 (d, j=10 Hz, 1H), 6.56-7.14 (t, 3H). [0046] 13 CNMR (125 MHz, CDCl3, ppm): 172.67, 154.23, 136.88, 131.04, 126.93, 117.67, 113.01, 82.02, 52.41, 50.83, 46.49, 43.40, 42.05, 38.23, 36.92, 34.74, 34.65, 33.35, 33.24, 31.93, 30.51, 29.92-28.22, 27.24, 25.62, 25.00, 22.63, 14.65, 14.09, 11.12. Example 2 Synthesis and Structure Confirmation of Compound I [0047] 1) Reaction Treatment [0048] 3 g (4.95 mmol) fulvestrant was added into a 250 mL round-bottom flask and dissolved with 160 mL methylene chloride while stirring. Then 0.0822 g (0.66 mmol) DMAP, 0.96 g (5.05 mmol) undecanoic acid and 1.02 g (4.98 mmol) DCC was added sequentially into said flask. After reacting under stirring at room temperature (e.g., 20±5) for 48 h, the reaction was stopped. [0049] 2) Post Process [0050] The reaction system was first frozen to precipitate as much reaction by-product DCU as possible. After being filtered to remove solid DCU, the filtrate was washed with saturated sodium bicarbonate solution, then washed with water to neutral and evaporated by rotary evaporator to remove methylene chloride, to give colorless and clear colloidal liquid, which was dissolved in a small amount of ethyl acetate and then froze in a refrigerator (e.g., the freezing temperature may be −15±3° C.) until no white solid DCU precipitated out. The filtrate was concentrated to remove ethyl acetate, recrystallized from mixed solvent of n-hexane-ethyl acetate, and then filtered to remove white solid precipitated out (unreacted raw material fulvestrant). The mother liquor was spin-dried to give colorless oily matter. Said oily matter was further purified by silica-gel column chromatography (the eluent was n-hexane-ethyl acetate (1:1, volume ratio)) and was then evaporated by rotary evaporator to give 1.0611 g colorless oily matter, which was Compound I (purity 99.104% as determined by HPLC according to the same determination method in Example 1), and the molar yield was 27.7%. [0051] IR (cm-1): 3385, 2926, 2855, 1756, 1494, 1463, 1199, 1152, 1059, 1017, 985, 721. [0052] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.28 (s, 1H), 6.83 (d, 1H), 6.77 (d, 1H), 3.73 (t, 1H, J=8 Hz), 2.88-1.17 (t, 57H), 0.89 (s, 3H), 0.77 (s, 3H). [0053] 13 CNMR (125 MHz, CDCl3, ppm): δ 172.64, 148.52, 137.13, 126.91, 122.37, 120.10, 118.64, 81.93, 52.75, 51.03, 46.47, 43.33, 41.67, 38.23, 36.89, 34.50, 34.45, 33.85, 31.89, 29.67, 29.50, 29.63, 29.55, 29.49, 29.46, 29.34, 29.30, 29.26, 29.16, 29.12, 28.80, 28.23, 27.11, 25.70, 25.01, 24.88, 22.66, 14.62, 14.50, 11.50. Example 3 Synthesis and Structure Confirmation of Compound III [0054] 3 g (4.95 mmol) fulvestrant was added into a 250 mL round-bottom flask and then dissolved with 160 mL methylene chloride while stirring. Then, 0.0822 g (0.66 mmol) DMAP, 1.87 g (5.05 mmol) docosanoic acid and 1.02 g (4.98 mmol) DCC was added sequentially into said flask. After reacting under stirring at room temperature (e.g., 20±5° C.) for 48 h, the reaction was stopped. [0055] Reaction liquid was treated according to the post process in Example 2 to give 1.016 g white solid powder (purity 92.634%, determined by HPLC) (C18 column, mobile phase: 75% THF in water, flow rate: 1.0 mL/min, detection wavelength: 220 nm), which was Compound III, and the molar yield was 22.1%. [0056] IR (cm-1): 3607, 3424, 2919, 2851, 1754, 1495, 1471, 1199, 1153, 1141, 1112, 1081, 985, 719. [0057] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.28 (d, 1H), 6.83 (d, 1H), 6.77 (d, 1H), 3.74 (t, 1H, J=8 Hz), 2.91-1.05 (t, 79H), 0.89 (t, 3H), 0.77 (s, 3H). [0058] 13 CNMR (125 MHz, CDCl3, ppm): δ 172.64, 148.53, 137.13, 126.91, 122.37, 118.64, 81.93, 52.83, 51.11, 46.48, 43.34, 41.68, 38.24, 36.89, 34.50, 33.15, 31.94, 30.56, 29.94, 29.86, 29.71, 29.67, 29.63, 29.62, 29.51, 29.48, 29.37, 29.35, 29.27, 29.17, 29.13, 28.81, 28.23, 27.12, 25.70, 25.01, 24.88, 23.16, 22.66, 14.50, 14.01, 11.50. Example 4 Synthesis and Structure Confirmation of Compound IV [0059] 3 g (4.95 mmol) fulvestrant was added into a 250 mL round-bottom flask and then dissolved with 160 mL methylene chloride while stirring. Then, 0.0822 g (0.66 mmol) DMAP, 1.44 g (5.05 mmol) isostearic acid and 1.02 g (4.98 mmol) DCC was added sequentially into said flask. After reacting under stirring at room temperature (e.g., 20±5° C.) for 48 h, the reaction was stopped. [0060] Reaction liquid was treated according to the post process in Example 2 to give 1.0028 g colorless colloid (purity 99.312%, determined by HPLC) (according to the same determination method in Example 3), which was Compound IV, and the molar yield was 23.2%. [0061] IR (cm-1): 3396, 2928, 2866, 1748, 1494, 1466, 1364, 1198, 1149, 1121, 1058, 1017, 984, 720. [0062] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.28 (s, 1H), 6.83 (d, 1H), 6.76 (s, 1H), 3.74 (t, 1H, J=8 Hz), 2.35-1.03 (t, 71H), 1.09-0.94 (t, 3H), 0.89 (s, 3H), 0.77 (s, 3H). [0063] 13 CNMR (125 MHz, CDCl3, ppm): δ 171.15, 148.60, 137.03, 126.88, 122.45, 118.72, 81.94, 53.34, 53.04, 52.82, 51.39, 50.96, 48.46, 48.39, 48.32, 46.48, 43.33, 41.68, 38.21, 37.92, 37.86, 37.79, 36.89, 34.50, 33.16, 32.37, 32.05, 31.11, 30.56, 30.06, 29.96, 29.87, 29.69, 29.55, 29.50, 29.37, 29.32, 29.18, 28.81, 28.26, 27.11, 26.09, 25.65, 24.81, 22.66, 21.21, 19.40, 14.61, 14.50, 11.51. Example 5 Synthesis and Structure Confirmation of Compound V [0064] 0.36 g (0.6 mmol) fulvestrant was added into a 50 mL round-bottom flask and then dissolved with 25 mL methylene chloride while stirring. Then, 9.93 mg (0.08 mmol) DMAP, 0.113 g (0.61 mmol) undecenoic acid and 0.13 g (0.64 mmol) DCC was added sequentially into said flask. After reacting under stirring at room temperature (e.g., 20±5° C.) for 48 h, the reaction was stopped. [0065] Reaction liquid was treated according to the post process in Example 2 to give light yellow oily matter, which was further purified by silica-gel column chromatography for 3 times and neutral alumina for once and was evaporated to dryness to give 0.1 g light yellow oily matter (purity 96.010%, determined by HPLC) (according to the same determination method in Example 3). The obtained light yellow oily matter was Compound V, and the molar yield was 21.5%. [0066] IR (KBr, cm-1): 3387, 2927, 2855, 1736, 1652, 1494, 1461, 1356, 1312, 1198, 1154, 1121, 1059, 1016, 983, 721. [0067] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.27 (t, 1H), 7.15 (t, 1H), 6.87 (s, 1H), 6.82 (s, 1H), 6.43 (t, 2H), 5.99 (t, 1H), 3.74 (t, 1H, J=8 Hz), 3.2-1.1 (t, 51H), 0.89 (t, 3H, J=7 Hz), 0.77 (s, 3H). [0068] 13 CNMR (125 MHz, CDCl3, ppm): δ 170.90, 165.38, 151.71, 148.55, 137.10, 135.55, 126.91, 122.44, 120.94, 120.12, 118.79, 81.93, 52.77, 51.04, 46.50, 43.35, 41.71, 38.27, 36.91, 34.51, 33.18, 31.85, 30.56, 29.94, 29.87, 29.70, 29.62, 29.51, 29.36, 29.34, 29.19, 29.16, 29.09, 28.96, 28.81, 28.23, 27.13, 25.70, 24.88, 22.66, 14.50, 13.50, 11.10. Example 6 Synthesis and Structure Confirmation of Compound VI [0069] 0.36 g (0.6 mmol) fulvestrant was added into a 50 mL round-bottom flask and then, dissolved with 25 mL methylene chloride while stirring. Then, 9.93 mg (0.08 mmol) DMAP, 0.185 g (0.61 mmol) eicosapentaenoic acid and 0.13 g (0.64 mmol) DCC was added sequentially into said flask. After reacting under stirring at room temperature (e.g., 20±5° C.) for 48 h, the reaction was stopped. [0070] Reaction liquid was treated according to the post process in Example 2 to give 0.31 mg light yellow oily matter (purity 99.195%, determined by HPLC with the method referred to the method in Example 3), which was Compound VI, and the yield was 58%. [0071] IR (cm-1): 3396, 3012, 2927, 2855, 1756, 1609, 1494, 1456, 1312, 1198, 1137, 1058, 1018, 985, 719. [0072] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.28 (t, 1H), 6.84 (t, 1H, J=7.5 Hz), 6.77 (d, 1H), 5.43-5.32 (t, 10H), 3.74 (t, 1H, J=8 Hz), 2.87-1.18 (t, 55H), 0.97 (t, 3H, J=7.5 Hz), 0.77 (s, 3H). [0073] 13 CNMR (125 MHz, CDCl3, ppm): δ 172.38, 137.19, 132.05, 129.07, 128.84, 128.59, 128.29, 128.22, 128.10, 127.89, 127.03, 126.94, 122.34, 118.62, 81.94, 52.76, 51.05, 46.48, 43.34, 41.67, 38.23, 36.89, 34.50, 33.78, 33.15, 30.56, 29.95, 29.86, 29.68, 29.65, 29.50, 29.36, 29.18, 28.82, 28.24, 27.12, 26.56, 25.70, 25.66, 25.65, 25.56, 24.82, 22.66, 20.85, 14.50, 13.50, 11.50. Example 7 Synthesis and Structure Confirmation of Compound VII [0074] 0.36 g (0.6 mmol) fulvestrant was added into a 50 mL round-bottom flask and then dissolved with 25 mL methylene chloride while stirring. Then, 9.93 mg (0.08 mmol) DMAP, 0.2 g (0.61 mmol) docosahexenoic acid and 0.13 g (0.64 mmol) DCC was added sequentially into said flask. After reacting under stirring at room temperature (e.g., 20±5° C.) for 48 h, the reaction was stopped. [0075] Reaction liquid was treated according to the post process in Example 2 to give 0.1165 g light yellow oily matter (purity 99.051%, determined by HPLC with the method referred to the method in Example 3), which was Compound VII, and the yield was 21.1%. [0076] IR (cm-1): 3396, 3013, 2927, 2855, 1756, 1609, 1494, 1456, 1358, 1198, 1138, 1059, 1018, 984, 719. [0077] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.27 (t, 1H), 6.83 (d, 1H), 6.77 (t, 1H), 5.4-5.3 (t, 12H), 3.74 (t, J=8 Hz, 1H), 2.8-1.1 (t, 55H), 0.97 (t, 3H), 0.77 (s, 3H). [0078] 13 CNMR (125 MHz, CDCl3, ppm): δ 171.88, 148.47, 137.22, 132.05, 129.62, 128.58, 128.33, 128.29, 128.26, 128.11, 128.09, 128.04, 127.89, 127.64, 127.03, 126.93, 122.35, 118.62, 81.94, 52.76, 51.05, 46.48, 43.34, 41.67, 38.23, 36.89, 34.50, 34.34, 33.14, 30.56, 29.94, 29.85, 29.68, 29.65, 29.50, 29.36, 29.18, 28.82, 28.24, 27.12, 25.70, 25.66, 25.64, 25.55, 22.85, 22.66, 22.58, 20.57, 14.30, 14.10, 11.50. Example 8 Synthesis and Structure Confirmation of Compound VIII [0079] 1) Reaction Treatment [0080] 0.31 g (0.4 mmol) Compound V (synthesized in Example 5), 4 mL (40 mmol) acetic anhydride, 0.2 g (1.6 mmol) 4-dimethylaminopyridine (DMAP) was sequentially added into a 50 mL round-bottom flask. After reflux reacting for 48 h, the reaction was stopped. [0081] 2) Post Process [0082] After the reaction system was cooled, it was washed with water to neutral and phase separated. The organic layer was spin-dried and purified by silica-gel column chromatography through gradient eluting (the eluent was n-hexane-ethyl acetate (40:1/10:1/5:1, volume ratio)). Then, the eluent was evaporated to dryness to give milky white colloidal liquid, which was Compound VIII. [0083] IR (cm-1): 3449, 2927, 2855, 1736, 1651, 1494, 1461, 1373, 1360, 1311, 1245, 1198, 1154, 1121, 1045, 1027, 983, 896, 822, 720. [0084] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.27 (t, 1H), 7.15 (t, 1H), 6.87 (t, 1 H), 6.81 (d, 1H), 6.40 (t, 1H), 6.00 (d, 1H), 5.63 (t, 1H), 4.70 (t, 1H), 2.7-1.1 (t, 52H), 2.05 (t, 3H), 0.89 (t, 3H), 0.82 (s, 3H). [0085] 13 CNMR (125 MHz, CDCl3, ppm): δ 170.90, 165.36, 151.72, 148.56, 137.07, 136.97, 126.92, 122.43, 122.32, 120.92, 118.73, 82.76, 52.71, 50.98, 46.26, 42.94, 41.40, 38.20, 38.12, 37.06, 34.50, 33.17, 32.50, 32.41, 31.84, 29.85, 29.67, 29.55, 29.49, 29.35, 29.32, 29.18, 29.15, 28.79, 28.16, 26.96, 25.64, 22.78, 22.65, 21.17, 14.63, 12.02. Example 9 Synthesis and Structure Confirmation of Compound IX [0086] 0.3 g (0.35 mmol) Compound IV (synthesized in Example 4), 3.5 mL (35 mmol) acetic anhydride and 0.18 g (1.44 mmol) 4-dimethylaminopyridine (DMAP) was sequentially added and then 30 mL tetrahydrofuran was added into a 50 mL round-bottom flask. After reflux reacting for 48 h, the reaction was stopped. [0087] Reaction liquid was treated according to the post process in Example 8 to give milky white colloidal liquid, which was Compound IX. [0088] IR (cm-1): 3311, 2927, 2854, 1736, 1665, 1494, 1460, 1365, 1245, 1200, 1045, 1027, 984, 803, 720. [0089] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.27 (t, 1H), 6.82 (t, 1H), 6.76 (t, 1H), 4.70 (t, 1H), 2.77-1.08 (t, 49H), 2.05 (t, 3H), 0.81-0.95 (t, 27H). [0090] 13 CNMR (125 MHz, CDCl3, ppm): δ 174.36, 171.23, 148.55, 136.95, 126.90, 122.45, 122.39, 118.74, 118.71, 82.76, 53.11, 53.03, 52.81, 51.39, 48.45, 48.31, 46.25, 42.94, 41.40, 38.07, 37.78, 37.05, 34.50, 33.16, 32.36, 32.05, 31.93, 31.44, 30.19, 30.05, 30.03, 29.88, 29.67, 29.55, 29.49, 29.35, 29.30, 29.17, 28.80, 28.19, 27.52, 26.99, 25.66, 22.69, 21.17, 20.35, 19.93, 14.63, 12.02. Example 10 Synthesis and Structure Confirmation of Compound X [0091] 0.3 g (0.35 mmol) Compound V (synthesized in Example 5), 3.5 mL (35 mmol) butyric anhydride and 0.18 g (1.44 mmol) 4-dimethylaminopyridine (DMAP) was sequentially added and then 30 mL tetrahydrofuran was added into a 50 mL round-bottom flask. After reflux reacting for 48 h, the reaction was stopped. [0092] Reaction liquid was treated according to the post process in Example 8 to give milky white colloidal liquid, which was Compound X. [0093] IR (cm-1): 3441, 2927, 2855, 1734, 1651, 1494, 1460, 1197, 1154, 1120, 1092, 1019, 983, 803, 720. [0094] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.27 (t, 1H), 7.15 (t, 1H), 6.88 (t, 1H), 6.81 (d, 1H), 6.40 (t, 1H), 6.00 (d, 1H), 5.63 (t, 1H), 4.70 (t, 1H), 2.7-1.0 (t, 56H), 0.96 (t, 3H), 0.88 (t, 3H), 0.82 (t, 3H). [0095] 13 CNMR (125 MHz, CDCl3, ppm): δ 173.79, 165.38, 151.73, 148.57, 137.02, 136.99, 126.93, 122.45, 122.39, 120.60, 118.67, 82.45, 52.73, 50.99, 46.28, 43.02, 41.42, 38.21, 38.14, 37.10, 36.52, 36.28, 34.51, 33.19, 32.51, 32.43, 31.85, 29.86, 29.68, 29.56, 29.50, 29.36, 29.33, 29.19, 29.17, 28.81, 28.18, 27.58, 26.99, 25.65, 22.82, 22.66, 18.69, 14.50, 12.02, 12.00. Example 11 Synthesis and Structure Confirmation of Compound XI [0096] 0.69 g (0.89 mmol) Compound IV (synthesized in Example 4), 14.5 mL (89 mmol) butyric anhydride and 0.44 g (3.52 mmol) 4-dimethylaminopyridine (DMAP) was sequentially added and then 69 mL tetrahydrofuran was added into a 50 mL round-bottom flask. After reflux reacting for 48 h, the reaction was stopped. [0097] After the reaction system was cooled, it was washed with water to neutral and phase separated. The organic layer was spin-dried and purified by silica-gel column chromatography through gradient eluting (the eluent was n-hexane-ethyl acetate (40:1/10:1/5:1, volume ratio)). Then, the eluent was evaporated to dryness to give crude product, which was then treated by ultrasonic water washing for several times. During said water washing process, the crude product attached to walls of flask in the form of colloid and water phase was poured directly after washing. Washing was repeated until the product had no smell of butyric acid. Finally, the product was quickly eluted with ethanol and the solvent was removed in a decompressed oven to give milky white colloidal liquid, which was Compound XI. [0098] IR (cm-1): 3448, 2390, 2857, 1750, 1734, 1609, 1494, 1465, 1364, 1198, 1150, 1121, 1094, 1048, 1019, 984, 905, 803, 732. [0099] 1 HNMR (500 MHz, CDCl3, ppm): δ 7.27 (t, 1H), 6.82 (t, 1H), 6.76 (s, 1 H), 4.71 (t, 1H), 1.09-2.77 (t, 53H), 0.81-1.08 (t, 30H). [0100] 13 CNMR (125 MHz, CDCl3, ppm): δ 174.36, 173.78, 148.54, 136.95, 126.90, 122.45, 122.39, 118.73, 118.71, 82.45, 53.33, 53.03, 52.82, 51.39, 48.45, 48.31, 46.27, 43.00, 41.41, 38.08, 37.76, 37.09, 36.52, 34.50, 33.17, 32.36, 32.05, 31.10, 31.07, 30.05, 30.03, 30.01, 29.88, 29.68, 29.59, 29.55, 29.50, 29.35, 29.31, 29.21, 29.17, 28.81, 28.20, 27.57, 27.01, 25.67, 22.58, 22.40, 19.93, 18.59, 14.64, 13.69, 12.06. Example of Physicochemical Properties Example 12 Solubility Experiments of Fulvestrant and Ester Derivatives Thereof in Different Solvents [0101] Fulvestrant and ester derivatives of fulvestrant were accurately weighed to an appropriate amount respectively. Their solubilities (in mg/mL) in different oils and solvents were compared according to General Notice in Section 2 of Chinese Pharmacopoeia (2010). The results are shown in Table 1: [0000] TABLE 1 Solubilities of fulvestrant and ester derivatives thereof in different oils and solvents Castor Soybean Medium- Propylene Solvent oil oil chain oil PEG 400 glycol Compound II >100.2 >100 >10 2.9 10.2 Compound V ND 122 ND ND 12.2 Compound I ND 255 ND ND 2.9 Compound III ND 11 ND ND 0.4 Compound IV ND 28 ND ND 7.1 Fulvestrant 20* 5 ND 6.9 10.2 Note: *denote the reported values. [0102] It can be seen that, compared with the solubility of fulvestrant, the solubility of Compound II in lipophilic solvents including castor oil, soybean oil, medium-chain oil increased significantly, yet had almost no change in propylene glycol, and decreased significantly in hydrophilic solvent PEG 400; meanwhile, the solubilities of derivatives such as Compounds I, III and IV in lipophilic soybean oil were significantly greater than that of fulvestrant. Example of Drug Efficacy Example 13 The Growth Inhibition Effects of Fulvestrant, Compounds II and X on Human Breast Cancer MCF-7 Xenografted in Nude Mice [0103] Test drugs: fulvestrant, Compounds II and X are dispersed in oil and sterilized to be prepared as oiling agents respectively. [0104] Experimental animals and grouping thereof, source, germline and strain: BALB/c female nude mice, provided by Laboratory Animal Research Center of Academy of Military Medical Sciences of China (Laboratory animal production license: SCXK (Military) 2007-004), day-old: 35-40 days; body weight: 18-24 g. The mice was divided into negative control group, positive control group (fulvestrant oiling agent), drug treatment groups (Compounds II and X oiling agent respectively), with 5 mice in each group. [0105] Administration method, dose and time: the negative control group was administered with blank solvent (oil) by subcutaneous injecting 0.2 mL/20 g for once; positive control group was administered with fulvestrant oiling agent by subcutaneous injecting 100 mg/kg for once; drug treatment groups were respectively administered with Compounds II and X by subcutaneous injecting 100 mg/kg for once. [0106] Establishment of model and tumor measuring method: human breast cancer MCF-7 cell lines in logarithmic growth phase were prepared into a cell suspension of 5×10 8 /mL under sterile condition, with 0.1 mL of which being inoculated to nude mice at their right armpits subcutaneously. Xenografted tumors of nude mice were measured for diameter with vernier caliper, and animals were randomly grouped when the tumors grew to 100-300 mm 3 . The administration volume to each of the mice was 0.2 mL/20 g by subcutaneous injection at head and neck region. 28 days after administration, the mice were sacrificed and the tumors were stripped by surgery and weighed. Tumor inhibition rate was calculated (inhibition rate=(1-tumor weight in the experimental group/tumor weight in the control group)×100%). The results are shown in Table 2 below: [0000] TABLE 2 The growth inhibition effects of fulvestrant and ester derivatives thereof on human breast cancer MCF-7 xenografted in nude mice (X ± SD) Initial Final Tumor Dose Initial body animal Final body animal Tumor inhibition Group (mg/kg) weight(g) number weight (g) number weight (g) rate (%) Negative — 18.800 ± 0.748 5 21.200 ± 0.748  5 1.180 ± 0.795 — control group Fulvestrant 100 18.400 ± 0.490 5 15.800 ± 1.166** 5 0.392 ± 0.443 66.78 oiling agent Compound II 100 18.400 ± 0.800 5 15.200 ± 0.748** 5 0.426 ± 0.306 64.90 oiling agent Compound X 100 18.800 ± 0.748 5 15.600 ± 1.020** 5 0.402 ± 0.711 65.93 oiling agent Compared with the blank control group, *p < 0.05, **p < 0.01. [0107] The results show that all of fulvestrant and ester derivatives thereof have anti breast cancer effects.

1a

BACKGROUND OF THE INVENTION Such a gas mask has become known from WO 86/06643. According to this disclosure a fan aspirates surrounding air, which is purified by a suitable filter--particle or dust filter, or gas filter--and undesired harmful substances are thus removed. The filter is taken up in a filter housing, which also simultaneously contains the fan and the connections and actuation elements necessary for driving it. Depending on the filter used, different fan powers are required: a gas filter requires only a small flow, so that it will not be exhausted prematurely, and a particle filter requires a greater fan power due to its elevated flow resistance. One type of filter element is adapted to depress a switch so that the fan runs at one speed whereas the other type of filter element does not engage a switch such that the fan runs at the other speed. Another gas mask has become known from U.S. Pat. No. 3,496,703 which consists essentially of a backpack-like gas processing unit, which is connected to a breathing mask connected to a protective helmet via a fan connection. The air to be inhaled is processed in the gas processing unit by first passing ambient air through various filters and humidifying it. The respiration air thus processed is fed to the user of the gas mask and breathing equipment via the respiration hose. The delivery of the ambient air through the filters, the humidifier, and the respiration hose to the user of the gas mask and breathing equipment is ensured by an electric fan, which can be operated optionally from an internal or external battery. If the external battery is used to supply the fan with energy, the fan output can be varied in two steps, namely, a fast fan step and a slow fan step. It is disadvantageous in the prior-art gas mask and breathing equipment that the fan output can be changed only when an external source of energy is used to drive the fan, and that the fan output can be changed only manually. It happens in practice that, depending on the field of application and the working conditions, different filters must be inserted into the gas mask and breathing equipment. For example, particle filters are to be used if dust is released in the environment during work, or gas filters must be used if gaseous toxic substances can be expected to occur in the working area atmosphere. It may also happen that so-called combination filters must be used when both dust and gaseous toxic substances are to be suspected in the working environment. Known gas masks can in fact be adapted with respect to their fan power to the respective filter utilized and their service lives thus permit operational times that are as long as possible, but the person who wears the device, now as well as before, is left in uncertainty with respect to whether the filter utilized can be inserted in a functionally safe manner or whether during use it has become nearly exhausted and cannot be inserted again. In many cases of gas filtering, a breakthrough of the filter is either not noticed or can only be noticed later. Thus, for example, odorless harmful gases generally may not be detected by the wearer of the device. SUMMARY AND OBJECTS OF THE INVENTION The primary object of the present invention is to improve a gas mask and breathing equipment of the type described such that the state of consumption is monitored as a function of the filter insert used. This task is accomplished by the filter connection having a sensor identification or a connection marking (information element, identification element or coding) corresponding to the filter property of the filter insert, which marking activates a detection sensor that is sensitive to the harmful substance to be retained by the filter in the case of the filter insert used; the solution to the task can also be produced by having the filter connection open up into a pressure channel, which is derived from a pressure sensor. Since the type of filter used influences the mode of operation of the gas mask with respect to the fun power, a filter property which is exhausted during long-time use of the filter can now be recognized as early as possible in order to improve the monitoring of the gas mask used and the filter performance. Depending on the flow behind the filter, a measurement channel opening can be provided in the filter insert from which a measurement channel leads to the detection sensor for a gas sample. With excessive use of a filter, minimal quantities of the gaseous harmful material are passed through the filter, which are still not harmful to the wearer of the device, but which activate the more sensitive gas sensor to indicate a threatening filter breakthrough. For example, electrochemical gas sensors can come into play as the detection sensor, through which a current is produced in the presence of the gaseous harmful material, by means of which a warning or a indicator device signals the wearer of the device that a further utilization of the gas mask is no longer advisable and that he should thus withdraw from the region of danger. In this connection, a corresponding warning threshold can also be adjusted simultaneously by means of the identification, which threshold can be different for different gases, in the case of the respective detections sensors utilized. Electrochemical sensors may be differently sensitive to the different gases, so that a single sensor can detect several gases depending on the adjusted warning threshold. In the case of an incorrectly functioning inserted filter, leakages may occur, by which means harmful gas reaches the sensor, which indicates this situation and thus warns of it. The electrical contacts or signals triggered by the identification can be further processed by means of an electronic circuit and can be programmed, e.g., by means of a microprocessor by the manufacturer such that an optimal equipping of the gas mask is provided by the software for the respective insert desired by the customer. If a particle filter for retaining airborne particles with a smaller flow resistance or a gas filter with a higher flow resistance is utilized, either a smaller fan power or a higher fan power will be selected, by which the fan will be driven with a lower or a correspondingly higher rpm. If so-called combination filters are utilized, a flow resistance which is produced for this case will be correspondingly considered in the adjustment of the fan power. Even in fluctuating fields of use and with different types of filters, the wearer of the device can always depend on the fact that the fan power is in conformance with the necessary filter property. If the filter housings are used as plug-in filters, it is advantageous to arrange the filter marking in the outer area of the filter insert, e.g., on the outer surface of he filter housing facing the filter connection. Thus, when the plug-in filter is attached to the filter connection, the filter marking will engage the connection marking, and actuate a corresponding electric contact, which will adjust the output of the fan to the value which is necessary for the necessary flow of ambient air through the particle filter. Gas filters and combination filters are usually provided with a threaded connection, with which the filter insert must be screwed into the filter connection of the gas mask and breathing equipment. To provide such filters with threaded connection with a marking as well, without having to change the filters themselves, it is advantageous to provide a filter adapter, on the circumferential surface of which the filter marking is arranged and which can be attached to the filter connection. Thus, it is possible, on the one hand, to use the same filter connection as for the plug-in filters, because the marking has been transferred from the filter insert to the filter adapter, and, on the other hand, the filters with threaded connection do not need to be changed, and if the filter adapter is designed correspondingly, it will be possible to accommodate either a plug-in filter or a filter with threaded connection on the same filter connection. Since the type of the filter used influences the mode of operation of the gas mask and breathing equipment in terms of the fan output, it is useful, for improving the monitoring of the gas mask and breathing equipment used and the filter output, to recognize a filter property that is exhausted in the course of prolonged use of the filter as early as possible. To achieve this, it is advantageous to provide in the filter connection a sensor marking which activates a detection sensor, which is sensitive to the toxic substance retained by the filter insert, when the filter insert or filter adapter is attached. A measuring pipe opening, from which a measuring pipe for a gas sample leads to the detection sensor, is to be provided in the filter insert downstream of the filter. During excessive use of a filter, very small amounts of the gaseous toxic substance pass through the filter, and these very small amounts, though harmless for the user of the device, activate the far more sensitive gas sensor to indicate a threatening filter breakthrough. The suitable detection sensors may be, e.g., electrochemical gas sensors, which generate a current in the presence of the gaseous toxic substance, and this current causes a warning or indication device to signal for the user of the device that further use of the gas mask and breathing equipment is no longer advisable, so that he should leave the hazardous area. A corresponding warning threshold can also be set in this connection, and this threshold may be different for different gases for the detection sensors used. The electric contacts or signals brought about by the marking can be subjected to further processing by means of an electronic circuit and can be programmed by the manufacturer, e.g., by means of a microprocessor, such that the customer is able to provide the gas mask and breathing equipment with the necessary software for the desired use. In an advantageous embodiment of the filter marking, the marking may be designed as pins of various geometric shapes, which are arranged on the filter insert or on the filter adapter, and extend into corresponding recesses of the filter connection. In the assembled state of the filter insert or filter adapter with the filter connection, electric contacts are closed to influence the driving power of the fan and, if desired, to activate the detection sensors. Another possibility of implementing the necessary marking is to arrange magnetic surfaces, which actuate reed contacts arranged on the associated points of the filter connection, on the filter circumference or the adapter circumference according to a predeterminable pattern. To be sure, for the filter or adapter used, whether mounting or insertion of the filter is guaranteed, a pressure sensor is mounted in the connection housing, and this pressure sensor extends from the housing with a pressure pipe opening and measures the vacuum generated during operation. If a filter is inserted properly, vacuum is generated on the suction side of the filter when the fan is switched on, and this vacuum is sensed by the pressure sensor and is processed via the electronic circuit (microprocessor). Depending on the type of filter used, which is communicated to the circuit by the marking, different vacuum thresholds can be preset, and if the actual pressure exceeds or is below these vacuum thresholds, it is indicated that no filter has been inserted at all, or that the filter does not fit tightly, or the filter is charged (e.g., with dust particles) to the extent that the necessary filter output can no longer be reached. Both the pressure sensor and the gas sensor may be provided together, but the pressure sensor may also be mounted alone, in order to monitor at least the basic functions for reliable operation of the gas mask and breathing equipment. A further improvement of the monitoring possibility is achieved by providing the filter housing on the outer surface facing the filter connection with a coding for the type of gas, which transmits the type of gas to be filtered, in coded form, to a decoder. The coding of the type of gas may consist of strip-like reflection surfaces, wherein the decoder has a corresponding number of light emitters (e.g., LEDs), which direct bundled radiation toward the reflection strips when the filter is inserted, and, depending on their geometric arrangement, these reflection strips reflect the reflected radiation to radiation detectors. The number and position of the detectors hit by the reflected rays provides information on the type of filter (particle filter or gas filter), and, in the case of gas filters, additionally also on the type of filter inserted (in terms of the gas to be retained), and this information is transmitted to the electronic circuit for evaluation. This evaluation consists of setting the fan output, on the one hand, and of activating the corresponding gas sensor or selecting the corresponding warning thresholds, on the other hand. If a pressure sensor is also additionally present on the screw-in filter, filter marking on the adapter may be omitted. On the other hand, the marking on the adapter may be retained in this advantageous embodiment in order to send the information to the gas mask and breathing equipment indicating that a screw-type filter will now be attached, as a result of which only the electronic components for recognizing the type of gas will be activated, because these need not be activated by all means when a plug-in particle filter without intermediary of an adapter is to be accommodated by the filter connection. The coding of the type of gas makes it possible to utilize such a comfortable marking even if the filter connection itself has a threaded holder, into which the screw-in filters, coded for the type of gas, can be screwed. Instead of working with LEDs and reflection strips, it is also possible to provide, on the filter side, a number of annular, concentric elevations, which actuate corresponding microswitches on the side of the filter connection of the fan housing in the screwed-on state. The gas type coding may be arranged on the filter housing regardless of whether the filter is a screw-type or plug-type filter. The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which a preferred embodiment of the invention is illustrated. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 is a schematic view of a gas mask and breathing equipment with fan, filter, and protective mask according to the invention; FIG. 2 is a schematic perspective representation of a filter connection with a filter insert and the associated marking according to the invention; FIG. 3 is a schematic perspective representation of the filter connection with a filter adapter located in front of the gas filter according to the invention; and FIG. 4 is a schematic view of the screw-type filter with the gas type marking. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows a fan-supported gas mask and breathing equipment, in which a filter adapter 2 and a gas filter 3 are connected, one behind the other on the suction side, to a fan housing 1. A fan drive 40, indicated by a circle drawn in broken line, delivers the ambient air according to the flow arrow 4 in the direction of an outlet-side respiration gas hose 5, through which the filtered ambient air is delivered via filtered air connection 100 into a breathing mask 6. The mask 6 has an eye-protective lens 7 and an exhalation valve 8, and can be tensioned over the head of a mask user, not shown, via a strap 9. The fan housing 1 has a filter connection 10 with a recess 11 serving as a connection marking or connection identification means, into which corresponding pin 12 forming filter identification means of the filter adapter 2, acting as filter marking, extends. The adapter 2 has, on the suction side, a threaded insert 35, into which a screw thread 13 of the gas filter 3 is screwed. The connection lines between the housing 1, the adapter 2, and the filter 3, which are drawn in broken line, indicate the movements which are necessary for assembly of the individual components shown. FIG. 2 shows schematically the filter housing 1, and it shows a perspective view of the filter connection 10 with an inlet opening 41 for the filtered respiration gas to be delivered from the environment. The housing 1 has the recess, designed as the connection identification means 11, into which the corresponding filter marking or filter identification means 12, designed as a round pin, extends. The filter marking 12 is provided with a magnetic strip 14, which actuates an electric contact accommodated in the housing 1, e.g., a reed contact 15, when the markings 11, 12 engage each other. Due to the closing of the contact 15, the fan output necessary for flow through the filter insert 16 is set in a microprocessor, not shown, which is accommodated in the fan housing 1. On its housing surface 17 facing the inlet opening 41, the filter insert 16 carries the filter marking, which in turn consists of the round pin 12 provided with the magnetic strip 14, on the one hand, and, on the other hand, a square pin 22, the latter of which is received in a corresponding recess acting as a sensor marking 18 in the fan housing 1. The recess 18 and the square pin 22 together provide sensor identification means providing information from the filter insert 16 as to what is to be detected by sensor 44. The pin 22 forms an information source element and the sensor marking 18 forms an information receiving element upon engagement with the pin 22. The square pin 22 is provided with the magnetic strip 14 (as the information source), which actuates, in the inserted state (inserted into sensor marking 18), an electric reed contact 23, represented by broken line, as a result of which a detection sensor 44 belonging to the filter insert 16 will be actuated. The sensor marking 18 with the corresponding detection sensor 44 is adjusted to the filter material 19 contained in the filter insert 16. A measuring pipe opening 43 and a pressure pipe opening or pressure channel 42, which lead to the gas sensor 44 or a pressure sensor 45, respectively, are also arranged in the filter connection 10. A filter cover 20, which is provided with a perforation 21 on the suction side, is placed over the filter insert 16. The cover 20 serves to mechanically protect the filter insert 16. FIG. 3 shows the same the fan housing 1 as does FIG. 2, which contains the filter adapter 2, which also carries the filter marking 12, 22 on corresponding flaps 31, in its circumferential area 32. The adapter 2 is provided with a flow opening 33, through which the ambient air, purified in the gas filter 3, flows into the inlet opening 41 of the fan housing 1. The filter adapter 2 also has a threaded insert 35 for screwing in the gas filter 3 with its screw thread 36. The gas filter 3 has a filter opening 37 toward the atmosphere. The surface of the fan housing at the filter connection 10, facing the adapter 2 and the gas filter 3, carries three reflection photocells 46, which are arranged next to each other and consist each of an LED as a light source and a photodetector acting as a receiver. This structure provides a gas type decoder which is a further part of the sensor identification means. The LEDs emit light to reflection strips 50, which are arranged concentrically on the end face 47 of the gas fan housing at the filter 3 facing the filter connection 10, as is shown in FIG. 4. The reflection strips 50 form the gas type coding for the further part of the sensor identification means. The number and position of the strips 50 may be combined corresponding to the type of gas for which the filter 3 is suitable, so that corresponding reflected rays will hit the detectors 46, and generate an electric signal in them. The information on the gas filter 3 used, thus coded, is sent to the electronic circuit accommodated in the fan housing 1, so that the necessary fan output will be set, on the one hand, and, on the other hand, threshold values are established, which are important for the gas sensor 44 for sending a warning signal when it measures a gas concentration exceeding the threshold value, which warns of an imminent filter breakthrough. The view of the screw-in filter 3 according to FIG. 4 shows its end face 47 which faces the filter connection 10 and is interrupted by the filter opening 37 and is surrounded by the screw thread 36. The end face 47 carries two the reflection strips 50, the distance between which corresponds to the distance between the two outer LED/detector combinations 46; these emit their light onto the strips 50, and receive a correspondingly reflected signal. The central one of the LED/detector combinations 46 receives no reflected signal. While a specific embodiment of the invention has been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 12/890,303, filed Sep. 24, 2010 and titled “Ergonomic Backpack With Enhanced Fit,” attorney docket number NIKE.156494, the disclosure of which is hereby incorporated herein in its entirety by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable. TECHNICAL FIELD [0003] The present invention relates to backpacks. More particularly, the present invention relates to an ergonomic backpack that provides an enhanced fit. BACKGROUND [0004] Backpacks (also known as bags, packs, or rucksacks) are often worn to assist users in carrying loads. For example, in some instances, a user requires use of her hands and prefers to carry whatever items she needs on her back rather than in her hands. In other instances, the user must walk, run, cycle, or otherwise travel a long distance and can more easily carry items in a backpack than in her hands. Comfort while wearing a backpack is often of concern. [0005] Various comfort-enhancing techniques have been embraced over the years, including padded shoulder straps, curved shoulder straps, lightweight materials, waist straps, and sternum straps. While these techniques have made backpacks more comfortable, especially for extremely heavy loads, conventional backpacks still do not provide the user with optimum comfort. SUMMARY [0006] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. [0007] The present invention relates to an ergonomic backpack with an enhanced fit. The backpack may comprise a storage portion having one or more compartments, the storage portion having a top side, a bottom side, a left side, and a right side such that when the backpack is worn by a user, the top side is nearer to the user's head than the bottom side, the bottom side is nearer to the user's legs than the top side, the left side is nearer to the user's left shoulder than the right side, and the right side is nearer to the user's right shoulder than the left side. A secondary left shoulder strap is attached at a first end to the bottom and left side of the storage portion. A secondary right shoulder strap is connected at a first end to the bottom and right side of the storage portion, the secondary left shoulder strap and the secondary right shoulder strap each attaching to the storage portion such that when the strap is extended toward the top side, the strap forms an angle of approximately between zero and 45 degrees, measured to the left from vertical. [0008] A primary left shoulder strap is connected at a first end to the top and left side of the storage portion along a first connection area and is connected at a second end to the secondary left shoulder strap. A primary right shoulder strap is connected at a first end to the top and right side of the storage portion along a second connection area and is connected at a second end to the secondary right shoulder strap. [0009] The first and second connection areas are each spaced approximately the same distance from a substantially vertical bisecting line extending through the backpack from top to bottom. The first and second connection areas are substantially collinear with a substantially horizontal line extending across the top side of the backpack. The primary left and right shoulder straps are connected to the first and second connection areas at substantially equal angles relative to the substantially horizontal line extending across the top side of the backpack. [0010] When the primary left and right straps are not connected to the secondary left and right straps and are raised such that the primary left and right straps extend upward and away from the body of the user and are substantially parallel with a vertical plane extending through the user's body, the primary left strap, primary right strap, and the substantially horizontal line extending across the top side of the backpack are all tangential to a first circle having a radius of approximately between 5 and 12 centimeters, the first circle substantially parallel to the vertical plane extending through the user's body. When the primary straps are raised vertically in this way, the primary left strap and primary right strap curve away from the substantially vertical bisecting line at between approximately one-third to two-thirds of the length of each strap, the curve being substantially equal to the curve of an arc of a second circle having a radius of approximately between 7 and 11 centimeters, the arc measuring approximately between 25 and 55 degrees. BRIEF DESCRIPTION OF THE DRAWINGS [0011] The present invention is described in detail below with reference to the attached drawing figures, wherein: [0012] FIG. 1 is a perspective view of an ergonomic backpack with enhanced fit; [0013] FIG. 2 is a perspective view of an ergonomic backpack with enhanced fit being worn by a user; [0014] FIG. 3 is a perspective view of an ergonomic backpack with enhanced fit being worn by a user with the primary left and right shoulder straps not connected to the secondary left and right shoulder straps and raised substantially vertical; [0015] FIG. 4 is a plan view of the ergonomic backpack with enhanced fit shown in FIG. 3 with the primary shoulder straps raised substantially vertical and viewed facing the portion of the backpack that rests against a user's back; [0016] FIG. 5 is a partial plan view of the secondary right shoulder strap attachment area to the storage portion of the ergonomic backpack shown in FIG. 4 ; [0017] FIG. 6 is a plan view of an ergonomic backpack with enhanced fit with the primary shoulder straps raised substantially vertical and viewed facing the portion of the backpack that rests against a user's back, the backpack having a “yoke” connection between the primary shoulder straps; [0018] FIG. 7 is a plan view of a women's ergonomic backpack with enhanced fit with the primary shoulder straps raised substantially vertical and viewed facing the portion of the backpack that rests against a user's back; and [0019] FIG. 8 is a plan view of a women's ergonomic backpack with enhanced fit with the primary shoulder straps raised substantially vertical and viewed facing the portion of the backpack that rests against a user's back, the backpack having a “yoke” connection between the primary shoulder straps. DETAILED DESCRIPTION [0020] In conventional backpacks, comfort is not optimized even when comfort-enhancing features are incorporated into the backpack. The novel arrangement, positioning, and dimensions of features in the ergonomic backpacks with enhanced fit described in this application provide a user with optimal fit and comfort. FIGS. 1-6 illustrate examples of the present invention designed as unisex backpacks. FIGS. 7-8 illustrate examples of the present invention designed specifically for women. [0021] FIG. 1 illustrates an ergonomic backpack with enhanced fit 100 . Backpack 100 includes a storage portion 102 that includes one or more compartments capable of storing cargo. Storage portion 102 has a top side 104 , a bottom side 106 , a left side 108 , and a right side 110 . When backpack 100 is worn by a user (as illustrated in FIGS. 2-3 ), top side 104 is nearer to the user's head than bottom side 106 , bottom side 106 is nearer to the user's legs than top side 104 , left side 108 is nearer to the user's left shoulder than right side 110 , and right side 110 is nearer to the user's right shoulder than left side 108 . [0022] Storage portion 102 is connected to a first end 112 of a primary left shoulder strap 114 along a first connection area 116 . First connection area 116 is on the top and left side of storage portion 102 . Storage portion 102 is also connected to a first end (not shown) of a primary right shoulder strap 118 along a second connection area (not shown). The second connection area is on the top and right side of storage portion 102 . Secondary left shoulder strap 120 is attached at a first end 122 to the bottom and left side of storage portion 102 . Secondary left shoulder strap 120 is also connected to a second end 124 of primary left shoulder strap 114 . Similarly, secondary right shoulder strap 126 is attached at a first end 128 to the bottom and right side of storage portion 102 . Secondary right shoulder strap 126 is also connected to a second end 130 of primary right shoulder strap 118 . FIG. 1 illustrates buckles 132 and 134 connecting primary left shoulder strap 114 and primary right shoulder strap 118 to their respective secondary shoulder straps. Any number of connecting devices or techniques may be used to facilitate these connections. In some examples, the connections are detachable and/or adjustable. [0023] FIG. 2 illustrates ergonomic backpack with enhanced fit 100 while being worn by a user 200 . Primary left shoulder strap 114 is worn over the user's left shoulder 202 , and primary right shoulder strap 118 is worn over the user's right shoulder 204 . [0024] To better illustrate some of the novel features of the invention, FIGS. 3-8 show examples of an ergonomic backpack with enhanced fit with the primary and secondary shoulder straps not connected and the primary straps raised such that they extend upward and away from the body of a user wearing the backpack. As stated above, in some examples the primary and secondary shoulder straps may be detachable. FIGS. 3-8 are also intended to illustrate examples in which the primary and secondary shoulder straps are not detachable, even though the primary and secondary straps are shown not connected for illustration purposes. [0025] FIG. 3 illustrates a user 300 wearing ergonomic backpack 100 . A dashed line represents a vertical plane 302 extending through the body of user 300 . Primary right shoulder strap 118 and primary left shoulder strap 114 (not shown) are raised such that primary right shoulder strap 118 and primary left shoulder strap 114 extend upward from the body of user 300 and are substantially parallel with vertical plane 302 . Primary right shoulder strap 118 and primary left shoulder strap 114 also extend away from the center of backpack 100 when the primary straps are in this position, as is clearly illustrated in FIGS. 4-8 . [0026] FIG. 3 is intended for illustration purposes. It should be appreciated that gravitational force would cause backpack 100 to fall off of user 300 if user 300 attempted to wear backpack 100 with the primary straps in a raised, substantially vertical position as shown. FIG. 3 establishes a frame of reference for a more complete discussion of the novel features of backpack 100 in subsequent figures. [0027] FIG. 4 is a plan view of backpack 100 looking at the surface of backpack 100 that rests against a user's back. Primary shoulder straps 114 and 118 are raised to a substantially vertical position as shown in FIG. 3 . Secondary shoulder straps 120 and 126 are also shown, and storage portion 102 is shown as a dotted line so as to not distract from the explanation of novel features of backpack 100 . [0028] As discussed with regard to FIG. 1 , first end 112 of primary left shoulder strap 114 is connected to storage portion 102 along first connection area 116 . First end 402 of primary right shoulder strap 118 is connected to storage portion 102 along second connection area 404 . First connection area 116 and second connection area 404 are each spaced approximately the same distance from a substantially vertical bisecting line 406 extending through backpack 100 from top side 104 to bottom side 106 . First connection area 116 and second connection area 404 are substantially collinear with a substantially horizontal line 408 extending across top side 104 of backpack 100 . Primary left shoulder strap 114 connects to first connection area 116 and primary right shoulder strap 118 connects to second connection area 404 at substantially equal angles relative to substantially horizontal line 408 . [0029] In some examples, the material comprising primary shoulder straps 114 and 118 extends beyond connection areas 116 and 404 and along the surface of storage portion 102 and may meet at approximately substantially vertical bisecting line 406 , as indicated by dotted lines in FIG. 4 . In other examples, primary straps 114 and 118 end at connection areas 116 and 404 or extend a different length and/or geometry along storage portion 102 . [0030] Primary left shoulder strap 114 , primary right shoulder strap 118 , and substantially horizontal line 408 are all tangential to a first circle 410 having a radius 412 of approximately between 8 and 12 centimeters. First circle 410 is substantially parallel to vertical plane 302 shown in FIG. 3 . In one example, radius 412 measures approximately 10 centimeters. [0031] Primary left shoulder strap 114 and primary right shoulder strap 118 curve away from substantially vertical bisecting line 406 at between approximately one-third to two-thirds of the length of each strap, the curve being substantially equal to the curve of an arc 414 of a second circle 416 having a radius 418 of approximately between 7 and 11 centimeters. Arc 414 measures approximately between 25 and 45 degrees. In one example, radius 418 measures approximately 9.5 cm. In another example, arc 414 measures approximately 36 degrees. As used herein, an arc measurement of a certain number of degrees is defined by the angle whose sides are extended until the circumference of the circle is intersected. For example, when a 36-degree angle's sides are extended to the circumference of a circle from the center, the portion of the circumference between the extended sides is a 36-degree arc. FIG. 4 shows primary shoulder straps 114 and 118 as having the same amount of curve. In other examples, the curve could vary slightly to account for an individual's physique. [0032] Primary shoulder straps 114 and 118 may be of varying width. A range of desirable widths is shown in FIG. 4 , with the white areas representing the minimum desired width of each strap and the gray areas representing the maximum desired extent for optimal comfort. As illustrated, the width of each strap may vary within the range of approximately 2 centimeters and approximately 12 centimeters. As noted in some examples below, however, variation to greater and/or lesser widths do not depart from the scope of the present invention. In one example, at the area where the straps attach to storage portion 102 , the minimum desired width of each strap is approximately 3 centimeters, and the maximum desired width is approximately 8 centimeters. In another example, at the second ends of the primary shoulder straps where the primary straps connect to the secondary straps, the minimum desired width of each strap is approximately 1 centimeter, and the maximum desired width is approximately 5 centimeters. In a further example, at the area where the straps attach to storage portion 102 , the minimum desired width of each strap is approximately 4.125 (4 and ⅛) centimeters, and the maximum desired width is approximately 4.75 (4 and ¾) centimeters. In still a further example, at the second ends of the primary shoulder straps where the primary straps connect to the secondary straps, the minimum desired width of each strap is approximately 1.375 (1 and ⅜) centimeters, and the maximum desired width is approximately 3.5 (3 and ½) centimeters. [0033] The specific strap width selected can vary depending upon the activity for which backpack 100 is designed, anticipated size of the user, mobility concerns, anticipated clothing that will be worn under the backpack, and other considerations. As shown in FIG. 4 , the minimum desired strap width tapers from widest at connection areas 116 and 404 to narrowest where primary shoulder straps 114 and 118 connect to secondary shoulder straps 120 and 126 . [0034] Although not shown in the figures, a sternum strap and/or waist strap may be included in backpack 100 . In examples including a sternum strap, the sternum strap may attach to primary shoulder straps 114 and 118 from approximately where primary shoulder straps 114 and 118 begin to curve to second ends 124 and 130 of primary shoulder straps 114 and 118 . [0035] The maximum desired extent 420 of bottom side 106 of storage portion 102 is approximately 55 centimeters in the vertical direction from substantially horizontal line 408 . In one example, maximum desired extent 420 is approximately 50 centimeters. The first ends 122 and 128 of secondary shoulder straps 120 and 126 attach to storage portion 102 at a minimum desired vertical distance 422 of approximately 35 centimeters from substantially horizontal line 408 . In one example, minimum desired vertical distance 422 is approximately 39 centimeters. In another example, minimum desired vertical distance 422 is approximately 38.8 centimeters. It is appreciated that approximately 38.8 centimeters can be considered to be approximately 39 centimeters. [0036] The vertical distance 424 between substantially horizontal line 408 and both the midpoint of second end 124 of primary left shoulder strap 114 and the midpoint of second end 130 of primary right shoulder strap 118 is approximately between 20 and 35 centimeters. In one example, vertical distance 424 measures 28 centimeters. [0037] The horizontal distance 426 between the midpoint of second end 124 of primary left shoulder strap 114 and the midpoint of second end 130 of primary right shoulder strap 118 is approximately between 65 and 85 centimeters. In one example, horizontal distance 426 is approximately 75 centimeters. [0038] FIG. 5 illustrates in detail the attachment of first end 128 of secondary right shoulder strap 126 to storage portion 102 . Strap 126 attaches to storage portion 102 such that when strap 126 is extended toward top side 104 , strap 126 forms an angle having a desired range of approximately between 0 and 45 degrees, measured down (and to the left) from vertical. In some examples, the desired maximum of this angle is between 15 and 30 degrees. In other examples, the desired minimum of this angle is between 0 and 10 degrees. Combinations of desired minimum angles between 0 and 10 and desired maximum angles between 15 and 30 are also contemplated. In one specific example, the desired minimum angle is approximately 5 degrees, and the desired maximum angle is approximately 20 degrees. In another specific example, the desired minimum angle is approximately 10 degrees, and the desired maximum angle is approximately 15 degrees. [0039] When first end 128 is substantially perpendicular to sides 502 and 504 of secondary right shoulder strap 126 such that strap 126 appears rectangular, the attachment angle 506 of first end 128 to storage portion 102 corresponds to the angle of strap 126 from vertical. That is, attachment angle 506 is between 0 and 45 degrees measured up (and left) from horizontal line 508 and the angle of strap 126 measured down (and left) from vertical is also between 0 and 45 degrees. [0040] Dashed lines 510 and 512 indicate the desired angle range of sides 502 and 504 of strap 126 when sides 502 and 504 are substantially parallel, first end 128 is connected to storage portion 102 , and strap 126 is extended toward the top side 104 from first end 128 . Dashed line 510 indicates the maximum desired angle of sides 502 and 504 , which, when first end 128 is perpendicular to sides 502 and 504 , occurs when angle 506 is at the maximum desired. That is, when connection angle 506 is at the maximum desired, sides 502 and 504 are substantially parallel to dashed line 510 . Similarly, dashed line 512 indicates the minimum desired angle of sides 502 and 504 , which, when first end 128 is perpendicular to sides 502 and 504 , occurs when angle 506 is at the minimum desired angle of 0, resulting in sides 502 and 504 being substantially vertical. [0041] In some examples, dashed line 510 is at an angle of approximately 45 degrees measured down (and to the left) from vertical. In other examples, dashed line 510 is at an angle of between approximately 10 and 30 degrees measured down from vertical. In still a further example, dashed line 510 is at angle of approximately 20 degrees measured down from vertical. Dashed line 512 is substantially vertical. In other examples, dashed line 512 is at an angle of between approximately 0 and 10 degrees measured down (and to the left) from vertical. In other examples, first end 128 is not perpendicular to sides 502 and 504 , and first end 128 is attached at an angle selected to cause sides 502 and 504 to have an angle between dashed lines 510 and dashed lines 512 , as described above. [0042] It should be appreciated that FIG. 5 illustrates strap 126 attached such that sides 502 and 504 of strap 126 have an angle measured down and to the left of vertical between the angles represented by dashed lines 510 and 512 . Solid lines 514 and 516 , along with dashed lines 510 and 512 represent an approximate area of storage portion 102 on which it is desirable to attach first end 128 . As discussed above, minimum desired vertical distance 422 in FIG. 4 indicates the minimum desired vertical distance between substantially horizontal line 408 of FIG. 4 and the midpoint of first end 128 when attached to storage portion 102 . In some examples, the attachment illustrated in FIG. 5 is mirrored for secondary left shoulder strap 120 . [0043] FIG. 6 illustrates ergonomic backpack with enhanced fit 600 that has a “yoke” strap configuration. Backpack 600 is substantially similar to backpack 100 of FIGS. 1-5 except for the connection of the primary shoulder straps to the storage portion. Primary left shoulder strap 614 attaches to storage portion 602 along first connection area 620 , and primary right shoulder strap 618 connects to storage portion 602 along first connection area 622 . In FIG. 4 , the primary straps were shown as being tangential, along with a substantially horizontal line, to a circle. [0044] In the example shown in FIG. 6 , the area between the points along primary shoulder straps 614 and 618 that first touch circle 624 is filled in with material to form a yoke connection. Primary left shoulder strap 614 and primary right shoulder strap 618 are connected to each other and to storage portion 602 adjacent to first and second connection areas 620 and 622 with one or more pieces of material such that the one or more pieces of material form a curve between primary left shoulder strap 614 and primary right shoulder strap 618 substantially the same as the curve of circle 624 . [0045] Many backpacks, such as the backpacks illustrated in FIGS. 1-6 , are designed to be “unisex” and fit both men and women. Women often still prefer backpacks designed especially for the female physique. FIGS. 7 and 8 illustrate ergonomic backpacks with enhanced fit similar to the backpacks shown in FIGS. 4 and 6 but that are specifically designed for women. [0046] FIG. 7 illustrates an ergonomic backpack with enhanced fit 700 . As with backpack 100 of FIGS. 1-6 , backpack 700 includes primary left shoulder strap 702 , primary right shoulder strap 704 , storage portion 706 , and secondary shoulder straps 708 and 710 . In contrast to circle 410 of FIG. 4 , the circle 712 tangential to primary left shoulder strap 702 , primary right shoulder strap 704 , and substantially horizontal line 714 has a smaller radius 716 of between approximately 5 and 10 centimeters. In one example, radius 716 measures approximately 7.5 centimeters. [0047] The vertical distance 718 between substantially horizontal line 714 and both the midpoint of second end 720 of primary left shoulder strap 702 and the midpoint of second end 722 of primary right shoulder strap 704 is approximately between 20 and 35 centimeters. In one example, vertical distance 718 measures approximately 28 centimeters. In another example, vertical distance 718 measures approximately 27.3 centimeters. [0048] The horizontal distance 724 between the midpoint of second end 720 of primary left shoulder strap 702 and the midpoint of second end 722 of primary right shoulder strap 704 is approximately between 65 and 85 centimeters. In one example, horizontal distance 724 is approximately 75 centimeters. In another example, horizontal distance 724 is approximately 75.1 centimeters. [0049] Backpack 700 also differs from backpack 100 in the amount of curvature of primary shoulder straps 702 and 704 as represented by circle 726 . Arc 728 of circle 726 is between approximately 35 and 55 degrees. In one example, arc 728 measures approximately 45 degrees. Radius 730 is approximately between 7 and 11 centimeters. In one example, radius 7 30 measures approximately 9.5 centimeters. Other dimensions, such as the maximum extent of storage portion 706 relative to substantially horizontal line 714 , may be the same as for backpack 100 or may be smaller to account for the smaller size of the average woman relative to the average man. [0050] FIG. 8 illustrates an ergonomic backpack 800 with enhanced fit having a yoke connection between primary left shoulder strap 802 , primary right shoulder strap 804 , and storage portion 806 , similar to that discussed with regard to claim 6 . [0051] The present invention has been described in relation to particular examples, which are intended in all respects to be illustrative rather than restrictive. Alternative examples will become apparent to those of ordinary skill in the art to which the present invention pertains without departing from its scope. [0052] From the foregoing, it will be seen that this invention is one well adapted to attain all the ends and objects set forth above, together with other advantages which are obvious and inherent to the system and method. It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations. This is contemplated by and is within the scope of the claims.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of, and the claims the benefit of, U.S. application Ser. No. 14/249,079, filed on Apr. 9, 2014 and entitled “METHOD FOR STIMULATING RETINAL RESPONSE USING PHOTOACTIVE DEVICES.” The '079 application is a continuation of, and the claims the benefit of, U.S. application Ser. No. 12/528,832, which has an international filing date of Jul. 12, 2011 and is entitled “METHOD FOR STIMULATING RETINAL RESPONSE USING PHOTOACTIVE DEVICES,” and issued as U.S. Pat. No. 8,725,266 on May 13, 2014. The '266 patent is a U.S. national phase filing under 35 U.S.C. §371 of PCT/US2008/55332, filed on Feb. 28, 2008, which claims priority from U.S. Provisional Application No. 60/891,978, filed on Feb. 28, 2007. All of the aforementioned applications are included herein by reference. FIELD OF INVENTION [0002] The present invention generally relates to use of devices to stimulate retinal response within an eye and reduce or prevent degradation of retinal response in eyes, and more particularly, the invention relates to use of quantum dot devices to induce electrical stimulation of the retina. BACKGROUND OF THE INVENTION [0003] Many people suffer from various forms of retinal damage, such as retinitis pigmentosa, retinal detachment, diabetic retinopathy, and macular degeneration, which can lead to diminished sight and blindness. And, as the age of the general population increases, the number of people suffering from diminished sight due to these causes increases. [0004] Several devices have been developed to attempt to restore vision loss due to retinal damage. For example, silicon-chip based photovoltaic devices, which are attached to a portion of a retina, have been developed to stimulate rods and cones within the retina. Although such devices may provide some stimulation, the devices suffer from several drawbacks. In particular, the devices are relatively large (e.g., on the order of square millimeters). As a result, when placed on a retina, the devices block significant portions of light that would otherwise reach rods and cones located behind the devices. Another problem associated with these devices is that they are placed on a surface of the retina, which is delicate; thus, the retina surface may tear or otherwise become damaged when the devices are attached to the retina. [0005] Other, silicon-chip based devices, which are implanted subretinally have also been developed to attempt to improve vision in those suffering from retinal damage. Mild improvement of electrical response to light has been observed using these devices. However, several problems have also been observed. Specifically, because the devices are relatively large, once the devices are attached to the retina, oxygen is blocked from reaching cells adjacent to or proximate the devices. In addition, implantation of the devices is thought to further damage the retinal tissue. [0006] Accordingly, improved devices and methods for increasing electrical stimulation of photoreceptors and/or other portions of a retina within an eye are desired. SUMMARY OF THE INVENTION [0007] The present invention provides an improved method for stimulating electrical activity in an eye. More particularly, the invention provides a technique for implanting small, nanometer-sized photoactive devices to stimulate electrical activity within an eye and mitigate degradation of electrical response in damaged retinas. [0008] While the ways in which the present invention addresses the disadvantages of the prior art will be discussed in greater detail below, in general, the present invention provides a method for measurably increasing electrical response of an eye to light using non-obtrusive devices, while preserving the neural network. [0009] In accordance with one exemplary embodiment of the invention, a method for stimulating an electrical response of a retina includes injecting nano-scale, light-sensitive devices within a vitreous portion of an eye. [0010] In accordance with another embodiment of the invention, a method for stimulating electrical activity of a retina includes injecting a plurality of photoactive devices in a sub-retinal portion of the eye. [0011] In accordance with various embodiments of the invention, the photoactive devices include a quantum dot or nanocrystal. In accordance with various aspects of the exemplary embodiments, the quantum dot fluoresces in the presence of light. In accordance with additional aspects, the quantum dot changes potential upon application of light of certain wavelengths. In accordance with further aspects, a plurality of quantum dots, which produce a change in potential in response to different wavelengths, are used to stimulate electrical activity within an eye. Using quantum dots offers several advantages over prior-art techniques, because the quantum dot devices are much smaller (on the order of nanometers) than traditional chip-based devices used to stimulate retinal electrical response to light. [0012] In accordance with further embodiments of the invention, the photoactive devices are coated with a biocompatible material. In accordance with exemplary aspects of these embodiments, the biocompatible material is a bio-targeted material, configured to adhere to native retinal cells (e.g., ganglia, bipolar cells, or photoreceptor cells) and maintain a close interaction with these cells for an extended period of time. BRIEF DESCRIPTION OF THE FIGURES [0013] The exemplary embodiments of the present invention will be described in connection with the appended drawing figures in which like numerals denote like elements and: [0014] FIG. 1 illustrates an eye and exemplary injection points for photoactive devices, in accordance with various embodiments of the present invention; [0015] FIG. 2 illustrates a portion of a retina with injected photoactive material in greater detail, in accordance with various embodiments of the invention; [0016] FIG. 3 illustrates an exemplary quantum dot suitable for use in accordance with various embodiments of the invention; [0017] FIGS. 4-7 illustrate electroretinogram (ERG) measurements in control groups and rats injected with photoactive devices in accordance with the invention; [0018] FIG. 8 illustrates nuclei count in ganglion cell layers. inner nuclear layers, and photoreceptor nuclei for control sham, and active groups; [0019] FIG. 9 illustrates Morris Water Maze Test results for control and active groups; [0020] FIG. 10 illustrates Recovery Round, Maximal dark-adapted ERG results for active, sham, and control groups; [0021] FIG. 11 illustrates Morris Water Maze Test results for control and active groups; and [0022] FIG. 12 illustrates photomicrographs of a human retina. [0023] Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. The dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the present invention. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS [0024] The present invention provides an improved method for stimulating an electrical response in an eye and mitigating degradation of electrical response to light of an eye having a damaged retina. The method of the present invention may be used with a retina that is damaged due to retinitis pigmentosa, diabetic retinopathy, macular degeneration, retinal detachment, or other retinal trauma and may be implemented on any animal, having an eye with the general properties described herein. [0025] FIG. 1 illustrates a mammal eye 100 , which includes an optic nerve 102 , a lens 104 , a cornea 106 , an iris 108 , zonules 110 , a retina 112 , and a vitreous 114 . In accordance with various embodiments of the invention, photoactive material 116 is injected into eye 100 , e.g., using a hypodermic needle, such that the photoactive material is dispersed within vitreous 114 and proximate retina 112 . In accordance with alternative embodiments of the invention, photoactive material 116 is injected subretinally. [0026] FIG. 2 illustrates a portion of retina 112 in greater detail, illustrating possible injection sites and resting sites for photoactive material 116 . The retina includes Internal limiting member 201 , nerve-fiber layer 203 , ganglion-cell layer 205 , inner plexiform layer 207 , inner nuclear layer 209 , outer plexiform layer 211 , outer nuclear layer 213 , inner segments 215 , outer segments 208 , Bruch's membrane 206 , RPE 219 , and Choriocapillaris 221 . [0027] As noted above, photoactive material 116 may be placed on a surface 202 of retina 112 or in a subretinal area 204 , such as a space located between a Bruch's membrane 206 and outer segments 208 . Photoactive material 116 may be placed directly in such locations, or, as described in more detail below, the material may be coated with a bio-targeted material, which adheres to particular cells, such as ganglia or bipolar cells or photoreceptors 223 . [0028] In accordance with various embodiments of the invention, photoactive material 116 includes a quantum dot. A quantum dot is a semiconductor nanostructure that confines motion of conduction band electrons, valence band holes, or excitons (pairs of conduction band electrons and valence band holes) in three spatial directions. The confinement can be due to electrostatic potentials (generated by external electrodes, doping, strain, impurities), due to the presence of an interface between different semiconductor materials (e.g. in the case of self-assembled quantum dots), due to the presence of the semiconductor surface (e.g. in the case of a semiconductor nanocrystal), or any combination thereof. Dimensions of quantum dots are typically on the order of about 1 to about 100 nanometers, and typically about 10 to about 50 nanometers for self-assembled quantum dots. [0029] The quantum dots fluoresce, emit an electrical potential or current, or a combination thereof, when exposed to light. The electrical potential is thought to stimulate rods and cones or other portions of retina 112 . The color of fluorescence and properties of the electrical potential general depend on the shape, size, and materials used to form the quantum dot. [0030] Quantum dots for use with the present invention may be formed using a variety of techniques. For example, the quantum dots may be formed by creating a region of a first material having a first bandgap surrounded by a second material of a second bandgap, wherein the second bandgap is larger than the first bandgap. For example, a quantum dot may include a cadmium selenide (CdSe) core surrounded by a zinc selenide (ZnS) shell. [0031] Alternatively, self-assembled quantum dots nucleate spontaneously under certain conditions during molecular beam epitaxy (MBE) and metallorganic vapor phase epitaxy (MOVPE), when a material is grown on a substrate to which it is not lattice matched. The resulting strain between the grown layer and the substrate produces coherently strained islands on top of a two-dimensional “wetting-layer.” The islands can be subsequently surrounded by a shell to form the quantum dot. [0032] Individual quantum dots can also be created from two-dimensional electron or hole gases present in remotely doped quantum wells or semiconductor heterostructures. In this case, a surface is coated with a thin layer of photoresist. A lateral pattern is then defined in the resist by electron beam lithography. This pattern can then be transferred to the electron or hole gas by etching, or by depositing metal electrodes (lift-off process) that allow the application of external voltages between the electron gas and the electrodes. [0033] Quantum dots may also be formed in quantum well structures due to monolayer fluctuations in the well's thickness. [0034] FIG. 3 illustrates a quantum dot 300 suitable for use as photoactive material 116 . Quantum dot 300 includes an inner semiconductor 302 core formed of, for example, indium/gallium/phosphide, silicon, gallium arsenide, cadmium telluride, copper indium gallium selenide, indium gallium nitride, or organic materials such as polymer-fullerene heterojunctions (e.g., P3HT+C 60 ), organic nanocrystal solar cells (e.g., cadmium selenide or cadmium telluride), dye sensitized cells (e.g., dye and titanium oxide or nobelium oxide), or a tandem cell (e.g., copper-phthalocyanin+C 60 ); a shell 304 , formed of, for example, zinc selenide or other suitable material; a coating 306 , formed of, for example, PEG lipids or other suitable material; and bio-functional material 308 , formed of, for example, biotin or other suitable proteins. [0035] As noted above, in accordance with various embodiments of the invention, a plurality of quantum dots exhibiting a plurality of fluorescence wavelengths or dots responsive to light of varying wavelengths are employed to stimulate photoreceptors based on incident light of multiple wavelengths. For example, a combination of nanoparticles responsive to red, blue, and green incident light may be employed. Various other combinations of nanoparticles/quantum dots are also within the scope of the invention. [0036] Use of photoactive nanoparticles such as quantum dots is advantageous because it allows for less invasive methods of implanting the devices, which in turn minimizes trauma and scaring of the retina. In addition, because the particles are so small, the particles block relatively little light from photoreceptors 210 (illustrated in FIG. 2 ). Further, the quantum dots can be injected into a wider field of vision, compared to larger devices. [0037] FIGS. 4-7 illustrate electroretinograms (ERG) for Royal College of Surgeons (RCS) rats with retinal degeneration, injected in vitreous 114 with about 5 μL of quantum dots 300 in saline, for a sham group, and for a control group. Intravitreal injections: 0.5 μl injected 1 mm posterior to limbus; subretinal injection: 0.1 μl injected under direct visualization subretinally. [0038] FIG. 4 illustrates maximal dark-adapted ERG, which elicits both rod and cone photoreceptor response, in RCS rats. The control group (n=4) has had no intervention, the sham group (n=4) has received intraocular injections of saline, and the QD-540 group (n=6) has received intraocular injections of quantum dots with a biotin coating. FIG. 4 illustrates an increase in the electrical activity of the active implant eyes in weeks 3 through 7, compared to the sham and control groups, which progressively decline. [0039] FIG. 5 illustrates photopic light-adapted ERG results, which elicit predominantly cone photoreceptor responses, in the RCS rats. The control group (n=4) has had no interventions, the sham group (n=4) has received intraocular injections of saline, and the QD-540 group (n=6) has received intraocular injections of quantum dots with a biotin coating. FIG. 5 demonstrates a general trend for increasing electrical activity in the active implant group, compared with a tendency for decline in the sham and control groups over time. [0040] FIG. 6 illustrates ERG recordings week 3 after injection. Line 602 indicates the ERG of an RCS rat with intraocular QD-540, compared with recordings from a representative sham surgery eye, illustrated by line 604 . FIG. 7 illustrates representative ERG recordings at week 7. Line 702 indicates the ERG of an RCS rat with intraocular QD-540, compared with recordings from a representative sham surgery eye, represented by line 704 . As illustrated, although the overall ERG amplitudes for both sham and injected eyes have decreased, the eye with the active implants has maintained a relatively normal ERG, whereas the sham eye recording is essentially flat. [0041] FIG. 8 illustrates nuclei count following a 2 month post-implantation ERG recording. The RCS rats then were euthanized and the eyes enucleated and the retina embedded in a plastic medium, then cut to 0.5 micron thickness and stained with toludine blue. Using image analysis software, the number of nuclei present in the ganglion cell layer, inner nuclear layer, and the photoreceptor nuclear layer (outer nuclear layer) were measured on five sections each 100 microns in length. There were three animals in the active implant group, 2 in the sham surgery group, and 1 in the control group. [0042] FIG. 8 shows no appreciable difference between the groups in the number of cells present in the ganglion cell layer, a trend for increased cells for both the active implant and sham surgery groups in the inner nuclear layer, and a marked increase in the photoreceptor nuclei in the active implant group. The photoreceptors are the basis of the electrophysiologic network of signals which produce the sensation of vision. Increased numbers of cells in this layer in the active implant group indicates a protective effect of the active implant on these cells. This is consistent with FIGS. 4-7 , which depict a preservation of the electrical functioning of the retina in the active implant groups. The intraocular quantum dots appear to preserve both the function and the anatomy of the retina in this model of progressive blindness. [0043] FIG. 9 illustrates results of the Morris Water Maze Test results for three groups. Each group, consisting of one control animal and one active implant animal, was tested in a water maze. The Morris Water Maze Test is a functional test to determine whether or not the animal can see light. The test consists of a water escape pool (1.4 m diameter, 0.6 m deep, water at 20 deg Celsius). Around the edge of the pool are six lights. The escape platform, a small pedestal approximately 12 cm in diameter, is randomly placed adjacent to one light, which is then illuminated as the rat is placed in the water. The subject then has 60 seconds to swim towards the light and climb up onto the pedestal. If the subject does not find the pedestal within 60 seconds, the animal is removed from the pool. Each animal is tested a total of ten times. [0044] In the group of animals 8 weeks post-implantation, the active implant animal was able to escape an average of 30% faster than the control animal. In the 5 week post-implantation group, the active implant group escaped an average 13% more rapidly than the control group and in the 4 week post-implantation group, the active implant had escape times 15% faster than the control. [0045] The results indicate that the animals receiving the active implant were consistently able to navigate the maze more rapidly than the control animals. The maze is specifically designed to eliminate any tactile or olfactory cues, and the animal must rely entirely upon sight to successfully exit. [0046] FIG. 10 illustrates Recovery Round, Maximal dark-adapted ERG in RCS rats. This test elicits both rod and cone photoreceptor response. FIG. 10 illustrates results from experiments involved in the intraocular injection of quantum dots to reverse blindness. The RCS rats were monitored with electroretinograms every other week until the recordings became essentially flat, indicating a loss of retinal functioning. The control group (n=2) has had no intervention, the sham group (n=2) has received intraocular injections of saline, while Groups Active Implant 593 (n−2) and Active Implant 614 (n=2) have received intraocular injections of quantum dots with an amino acid coating. 593 and 614 refer to the wavelength of light to which each quantum dot exhibits a maximum response. Recordings were taken the day of surgery, 2 weeks post-implantation and 4 weeks post-implantation. [0047] The graph illustrates that both the control and sham surgery groups exhibit no gain in the electrical functioning of the retina at any point post-operatively. In contrast, both active implant groups had a substantial increase in the electrical activity of the retina post-implantation. The Active Implant 593 group had a 2-fold increase in the amplitude of the waveform response to light, and the Active Implant group 614 had a 2.5-fold increase in the amplitude of the waveform response to light. [0048] FIG. 11 illustrates Morris Water Maze Test, Recovery Round results for three groups, each group consisting of one representative animal, tested in a water maze. The test consists of a water escape pool (1.4 m diameter, 0.6 m deep, water at 20 deg Celsius). Around the edge of the pool are six lights. The escape platform, a small pedestal approximately 12 cm in diameter, is randomly placed adjacent to one light, which is then illuminated as the rat is placed in the water. The subject then has 60 seconds to swim towards the light and climb up onto the pedestal. If the subject does not find the pedestal within 60 seconds, the animal is removed from the pool. Each animal is tested a total of ten times. [0049] The graph indicates that the control group averaged 60 seconds, indicating that the maze was never successfully completed. The Active Implant 593 group averaged 50 seconds, 17% quicker escape time than control. The Active Implant 614 group averaged 27.6 seconds, nearly twice as fast as the control group, indicating a higher level of visual functioning. [0050] The results indicate that the animals receiving the active implant were consistently able to navigate the maze more rapidly than the control animals. The maze is specifically designed to eliminate any tactile or olfactory cues, and the animal must rely entirely upon sight to successfully exit. [0051] FIG. 12 illustrates photomicrograph of a human retina (A), and quantum dots adherent to human retinal photoreceptors (B). A whole human eye was obtained from the Rocky Mountain Lions Eye Bank and examined grossly and beneath an operating microscope and found to be free of any structural abnormalities. Next, 0.05 ml of a biotin linked quantum dot with an absorption wavelength near 528 nm and an excitation wavelength of 547 nm was injected into the subretinal space. After histological processing, the biotin linked quantum dots were visible by fluorescent light microscopy. The quantum dots could be seen adherent to the native photoreceptors (arrow), as well as in unbound aggregates in the subretinal space (arrowhead). This demonstrates that biotin linked quantum dots bind to human retinal photoreceptors when injected into an eye bank specimen. This has practical implications in the area of neural prosthetics and neural protection for targeted delivery of drugs, molecules, and electric current to photoreceptors in disease states. [0052] The present invention has been described above with reference to exemplary embodiments. Those skilled in the art having read this disclosure will recognize that changes and modifications may be made to the embodiments without departing from the scope of the invention. These and other changes or modifications are intended to be included within the scope of the present invention.

1a

BACKGROUND OF THE INVENTION The invention relates to physical rehabilitation tools, devices, equipment and methods for assisting persons in improving mobility and range of motion. More specifically, in one form, this invention relates to equipment which utilizes rotation, flexion and stretching to rehabilitate patients undergoing physical therapy. When older devices were in use, patients only had the ability to move appendages in one direction along a track, but this invention adds the ability to translate and rotate. This is a significant improvement, because it allows the body to move in a more natural way, which is believed to promote proper healing. Additionally, this embodiment works with a number of attachments. Older devices were limited to single use applications. SUMMARY AND OBJECTS OF THE INVENTION It is an object of this invention to provide patients with an apparatus that allows for the more natural movement of appendages during recuperative activity. It is also an object of this invention to construct an apparatus that is adaptable for use in a variety of institutional and residential settings. It is also an object of this invention to construct an apparatus that is adaptable in range of rotation, flexion, and stretching of appendages during recuperative activity. It is also an object of this invention to construct an apparatus that is adaptable in the amount and application of resistance against motion and movement of appendages during recuperative activity. It is also an object of this invention to provide a versatile base for many possible attachments to enhance the capabilities of the apparatus, and provide a single, convenient apparatus for multiple rehabilitation methods. Another object of this invention is to provide a caretaker with the ability to easily facilitate recuperation of the patient. The invention should be accessible for use by partially ambulatory as well as non-ambulatory patients. Additional objects and advantages of the invention will be evident from the description that follows, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and obtained by the instruments and combinations particularly pointed out in the appended claims. To achieve the foregoing objects, and in accordance with the invention as embodied and broadly described, herein is provided a physical rehabilitation apparatus. In one form, the apparatus comprises a base having an upper surface and lower surface. The lower surface can include a friction-inducing structure. A track is coupled to the upper surface of the base, which provides movement along a horizontal plane. A bearing is coupled to the track, providing rotational movement relative to the base. The track can, for example, consist of slide rails attached to the base that removably and slidably connect to slide rails attached to the bearing. In accordance with particular embodiments of the apparatus, attachments may be removably connected to the base, the track or the bearing. Attachments are adapted to perform varied types of exercises for the upper extremities or the lower extremities. For example, a foot rest or tread may be pivotally coupled to the bearing, which allows the recuperating person to use the foot rest to push horizontally, and the bearing allows for rotation of the foot rest or tread by manipulation of the recuperating person's foot. Also, attachments for use with the upper extremities may be coupled to the bearing. One attachment for the upper extremities consists of a hand crank. As the patient cranks the attachment, rotation about the bearing may allow flexion of muscles and rotation of the extremities about the joints of a patient. Another attachment consists of a sliding hand hold, which may help the patient develop flexibility and strength in the upper extremities. The person may push or pull horizontally, and the bearing allows for rotation about the joints in the person's upper extremities. Additionally, an inclination attachment can also be provided to allow individuals to change the angle of the base relative to a supporting surface, the angle ranging from 0 to 90 degrees, thereby increasing the resistance, due to gravity, provided against movement along the track by a patient during operation of the apparatus. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is an exploded view of a physical rehabilitation apparatus according to the present invention. FIG. 2 is a perspective view of the physical rehabilitation apparatus in use from a reclining position. FIG. 3 is a perspective view of the physical rehabilitation apparatus during rotation and translation of the tread along the tracks. FIG. 4 is a perspective view of the physical rehabilitation apparatus in use from a sitting position. FIG. 5 is an exploded view of a grip attachment. FIG. 6 is a partial exploded view of a hand crank attachment. DETAILED DESCRIPTION Referring to FIG. 1 , a base 10 , has a lower surface 11 . In one embodiment, the base 10 includes a board 13 , or other structure having a flat surface. However, a flat surface is not required. For example, the lower surface 11 could be comprised of one or more legs. A friction-inducing structure 20 can be included on the lower surface 11 to help prevent the apparatus from moving during operation. The friction-inducing structure 20 can assist the patient in using the apparatus on surfaces such as linoleum floors, waxed wooden floors, bed sheets, blankets, comforters or quilts, by providing stability on an otherwise somewhat slippery surface. The base also includes an upper surface 12 . The upper surface 12 of the base is coupled to a track 30 , which in one form can be substantially flat. The track 30 preferably provides a smooth, even, and durable system for translating kinetic energy into longitudinal motion. In the depicted embodiment, the track 30 is similar to the heavy-duty slides used for the drawers of filing cabinets, tool cabinets, some dressers and other similar applications. However, it is important to note that the track 30 is not limited to the depicted embodiment. Any form of suitable track could be used, such as those used for monorails, overhead cranes, telescopes, or other conveyances. The track 30 is coupled to a platform 40 . The platform 40 includes an upper member 42 and a lower member 44 . The platform 40 preferably slides horizontally along the length of the track 30 . The platform 40 preferably provides a stable surface for subsequent placement of additional components of the apparatus on top of the track 30 . The platform 40 is coupled to a bearing 50 . For example, as shown in FIG. 1 , the bearing 50 is disposed between the upper member 42 and the lower member 44 of the platform 40 . The bearing 50 rotates clockwise and counter-clock wise about an axis 17 substantially perpendicular to the base 10 . The bearing 50 may come in various embodiments, ranging from a simple peg to a series of concentric cylinders or spheres. The bearing 50 allows rotation about an axis 17 as explained hereafter or rotation about an axis in some other manner. Further, referring to FIG. 3 , the bearing 50 is shown with its rotational capability, and the platform 40 is shown coupled to the track 30 , with the capability of sliding along the length of the track 30 . FIG. 4 further highlights these relationships. Referring to FIG. 1 , the bearing 50 is depicted as coupled to a tread 60 . The tread 60 is able to move rotationally, via the bearing 50 , and horizontally, through sliding the bearing 50 along the length of the track 30 . In one embodiment, as depicted in FIG. 1 , the tread 60 includes a first member 64 and a second member 66 . For example, suppose the tread 60 is a rehabilitation boot, the first member 64 may be the sole of the boot and the second member 66 may be the back of the boot. In another embodiment, other types of tread 60 may be used to accommodate other physical rehabilitation exercises (to be described further starting paragraph [0037]). However, other suitable forms of the tread 60 may include structures such as a boot or other foot-confining device that can accommodate a foot from the patient. The boot may have lashes, latches, Velcro straps or buckles that help maintain the stability of the foot while operating the apparatus. Referring to FIG. 1 , in one form, the Velcro straps 65 can allow a patient or caretaker to easily secure the foot of the patient to the tread 60 in a durable and comfortable manner. The tread 60 is coupled to a handle 62 . The handle 62 provides a caretaker the ability to manipulate the tread 60 while a patent operates the apparatus. Patients with severe restrictions upon their mobility receive assistance from caretakers during operation of the apparatus. This increases the safety and efficacy of the apparatus. A hinge 63 is coupled to the tread. The hinge 63 provides the tread 60 with an additional degree of movement. Using the hinge 63 , a patient can move his lower appendage toward or away from the platform 40 , through a 90 degree arc. This increases the ability to engage in presumably recuperative movement. Also, the tread 60 is coupled to a rope 72 . The rope allows a patient to use an alternate force to control the motion of the appendage in the tread as it traverses the track. For patients with physical limitations on the flexion, strength, or range of motion, the rope 72 assists the patient or the caretaker with operating the apparatus. Additionally, the tread 60 is coupled to a knee lock prevention device 130 . The knee lock prevention device prevents the tread 60 from touching the platform 40 , thereby preventing the complete flexion of the leg, which may cause a knee to lock in an immobile patient with reduced flexion and mobility. Another safety feature of the apparatus is the existence of stops 67 . Stops 67 allow the patient or caretaker to limit the horizontal motion of the apparatus, to avoid injury or discomfort during use of the apparatus. The stops 67 prevent the platform 40 from traversing the entire length of the track 30 , but the stops 67 do not prevent the natural movement of the patient's appendage. The patient is still able to move the appendage within the tread 60 about the axis 17 , which the bearing 50 allows. Additionally, the stops 67 provide a mechanism for adjusting the position of the platform 40 , in relation to the track 30 , which allows greater stability during particular applications, such as when a patient is standing while operating the apparatus. In the prior art, machines that had the ability to move appendages lengthwise along a track, but did not have the capability of locking in place and using rotation to improve the recovery of a patient. In one embodiment, a frame 90 allows the apparatus to vary in angular relation to a surface supporting the patient. A resistance adjuster 80 secures the base 10 in place once the patient (or caretaker) has established his preferred confirmation for operation. Once the angle of the base 10 is shifted in relation to a floor or a bed, the resulting incline uses the force of gravity to alter the resistive effect of the apparatus. The base 10 may be adjusted via the resistance adjuster 80 to range from flat to vertical, in relation to the bed or floor. While the physical rehabilitation apparatus has been illustrated as above, there may be many variations on the basic embodiment shown. For example, in one form, the bearing can be a semi-circular ball-in-socket connection between the track and the tread, to provide rotation about an axis perpendicular to the base, with an additional range of motion allowing a plane formed by the bottom of the tread to range from substantially parallel to the plane formed by the surface of the base to substantially perpendicular to the plane formed by the surface of the base. (Not shown in figures.) In one form, the physical rehabilitation apparatus allows the addition of other exercise functions to the basic structure. Generally, the other exercise functions can require the base to be positioned either flat on a support surface such as a bed, floor, or table, or at a 90 degree angle to the support surface. For example, one form comprises a hand crank 150 coupled to the bearing 50 . The hand crank 150 allows the patient to use the apparatus for improving the rotation, flexion and stretching capabilities of upper appendages. The base can be positioned either flat or 90 degrees relative to a support structure, and the platform can be locked in place to resist moving along the track. Locking the apparatus thereby provides stability for the hand crank 150 while allowing rotation of the hand crank 150 and the upper appendages about an axis 17 . Another form comprises a grip 200 coupled to the bearing. The grip 200 allows the patient to push or pull the bearing along the track, while simultaneously rotating the bearing around the axis 17 . The grip 200 allows the patient to improve dexterity, rotation, and flexion of the upper appendages, joints, and phalanges. Similar to the example above, when using the grip 200 , the base can be positioned either flat or 90 degrees relative to a support structure. When in use, the motion of the grip can be similar to the physical motion of an iron along a garment. The grip can rotate about an axis 17 , while simultaneously translating along the length of the track 30 . In use, the physical rehabilitation apparatus provides a number of improvements over older devices. The ability to translate kinetic energy into longitudinal motion and rotational motion simultaneously presents a number of benefits. It allows a patient or caretaker to better approximate a natural range of motion. For example, the physical rehabilitation apparatus may be operated while positioned parallel to the body of the patient, or it may be positioned in a confirmation that is horizontal to the body of the patient. It also allows the patient or caretaker to use the apparatus for a wider range of applications or areas of focus. The physical rehabilitation apparatus also allows the patient or caretaker to use the device in a number of settings, both institutional and residential. For example, the physical rehabilitation apparatus may be used by a patient as the patient is lying down, seated, or in a semi-reclined position. The physical rehabilitation apparatus may be on a floor or table, while the patient remains seated in a chair or lying on a bed. The additional ranges of motion granted by the bearing and the hinge are believed to increase the overall versatility, flexibility, and applicability of the apparatus as used for recuperative purposes. The resistance adjuster provides the ability to increase the required exertion used by the patient to operate the apparatus. Increasing the resistance may assist in building strength and flexibility during the recuperative process. It should be noted that when older devices were in use, a patient needed to rely upon a caretaker or therapist to provide additional resistance. Although a caretaker may assist in using this apparatus, such assistance may often prove unnecessary. Furthermore, the apparatus allows a caretaker to have additional treatment options. The apparatus may be optimized for the condition of the individual patient. The stops may be employed to prevent hyperextension or unwanted exertion. The resistance to any individual form of motion may be adjusted to a level deemed appropriate. The handle on the tread may be used to assist the patient in moving translationally or rotationally. The rope also provides a caregiver or patient with a way to augment the patient's own physical exertion during operation of the apparatus. When other attachments are in use, the caregiver can guide the patient's movement by manipulating the patient's appendages or the attachments themselves. It will be appreciated that the invention provides a versatile, multifunctional exercise structure of convenient readily constructed design. Additionally, although the structure may be manufactured predominantly in metal and wood, the design lends itself to having significant portions molded in plastic or composed of rubber. The above is only illustrative of the principles of the invention, and is not to be construed as limiting the invention to the exact construction and operation shown and described. Accordingly, all suitable modifications and equivalents will fall within the scope of the invention. All changes which come within the range and meaning of equivalency of the claims are embraced within their scope.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to soles for shoes and more particularly relates to a midsole for an athletic shoe. 2. Description of Related Art Soles in athletic shoes are expected to provide shock absorption and stability. Shock absorption minimizes the impact of a runner's footfalls to lessen stress on the leg muscles and joints. Stability is necessary to control the amount of lateral motion of a foot in order to prevent over pronation thereby lessen the stress on the lower legs. During normal motion, the foot of a typical runner hits the ground heel first. The foot then rolls forwardly and inwardly over the ball of the foot. During the time that the foot is moving from heel strike to the ball of the foot, the foot is typically rolling from the outside or lateral side, to the inside or medial side of the foot; a process called pronation. After the ball contacts the ground, the foot continues rolling forward onto the toes. During motion through ball and toe contact, the foot rotates outward as the toes prepare to push off; a process called supination. The foot remains supinated while it is lifted off the ground between footfalls. Pronation, the inward roll of the foot in contact with the ground, although normal, can be a potential source of foot and leg injury if it is excessive. Many prior art soles have been designed with the goal of preventing over pronation and controlling supination. The lateral motion of the foot, that is abduction and adduction, can be controlled by providing a stable sole. However, as the stability of the sole increases, the shock absorption properties of the sole decrease. Thus, soles must be designed to properly balance the properties of stability and shock absorption to provide optimum characteristics for both parameters. This design goal is further complicated by the fact that foot size is largely unrelated to body mass. For example, two people of equal weight may have feet that are two or three sizes apart and conversely, two people with the same foot size may have substantially different body mass. Thus, a shoe that is stable for a 130 pound, size 9 runner may not be stable for a 160 pound, size 9 runner. Durability of the midsole, as measured by its ability to withstand cyclical loading without degradation of midsole properties, is also an important design goal. Most present-day athletic shoes use a midsole of an elastomeric foam, such as ethylene vinyl acetate (EVA). EVA foam allows designers to adjust the density, and hence the hardness, of the foam to provide various midsole properties in an attempt to balance shock absorption and stability. As is well-known to those skilled in the art, the higher-density EVAs provide a stable platform but less shock absorption, while the low-density EVA foams provide better shock absorption but less stability because they cannot control the lateral movement of the foot. EVA foams typically have a useful life of approximately 800,000 cycles before there is a noticeable degradation in their performance. For these and other reasons, there is a continuing search for alternative midsole designs. Cohen, U.S. Pat. Nos. 4,753,021 and 4,754,559, discloses a midsole for a shoe having a sheet of rubber-like material with a plurality of ribs separating an upper and lower surface. As a load is applied to the midsole the ribs collapse thereby absorbing energy. As a load is removed the resilient nature of the ribs causes them to spring back to their previous shape. Cohen discloses plural embodiments including those in which the ribs form channels that are arranged parallel to, and orthogonal to a longitudinal axis of the elongate sole. Because of the design and choice of materials, Cohen would not represent an enhanced performance sole for use in an athletic shoe. SUMMARY OF THE INVENTION The present invention seeks to provide a midsole having superior stability and shock absorption properties in a midsole design that can be customized for different applications and body-type characteristics. In addition the present invention seeks to provide a high performance midsole having superior durability. A preferred embodiment of the present invention provides a molded midsole formed of an elastomer whose ration of plastic deformation to elastic deformation is greater than 1.5 to 1. Preferably, the elastomer is a copolyester polymer elastomer such as that manufactured and sold by E. I. dupont de Nemours under the trademark HYTREL. The present invention has been cyclically loaded to 1.2 million cycles before suffering a degradation of performance. This represents a 50% increase in useful life over typical prior art EVA foam soles. In the preferred embodiment, the midsole is an integral, one-piece-molded midsole having a curvilinear, elongate top surface and a plurality of integrally molded, transversely arranged tubes which individually function as compression spring elements. A lower surface is integrally molded with the lower portion of the tubes thereby providing more structural integrity for the midsole and providing a surface upon which an outer sole may be applied. The performance properties of the midsole can be controlled by changing the spring constant of the tubes such as by increasing the wall thickness of the tubes, increasing the tubes' length or the hardness of the material. For example, in the heel section of a preferred embodiment, short tube segments are provided along lateral and medial edges of the midsole thereby providing a central opening having no tubes therein. The midsole can be designed so that the tubes along the medial edge have thicker wall sections, or are slightly longer, than the tubes along the lateral edge, thereby creating a higher spring constant and providing control for over pronation. Also, a preferred embodiment includes forefoot tubes having slit-like openings along their length to permit a great deal of midsole flexibility along the longitudinal direction. Additionally, the wall thickness of the forefoot tube can be greater along the medial edge than the lateral edge, or vice versa, to provide lateral stability for different types of runners, e.g., over pronators. In other preferred embodiments of the invention the midsole is manufactured in two pieces comprising a forefoot section and a rearfoot section. Each individual section would substantially resemble its respective portion of the one-piece integrally molded midsole. However, by manufacturing the midsole in two pieces it may be possible to reduce the number of manufacturing molds. Additionally, it would be possible to mix properties between various rearfoot sections and forefoot sections. For example, a rearfoot section designed for a heavy heelstrike-type runner and having good shock absorption could be combined with a forefoot section providing substantial stability against over pronation. Various advantages and features of novelty which characterize the invention are particularized in the claims forming a part hereof. However, for a better understanding of the invention, its advantages, and objects obtained by its use, reference should be had to the drawings which form a part hereof and to the accompanying descriptive matter in which there is illustrated and described preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view of a running shoe worn by a runner. FIG. 2 is a top plan view of a preferred embodiment of a midsole of the present invention. FIG. 3 is a side elevation view taken of the midsole of FIG. 2. FIG. 4 is a perspective bottom view of a preferred embodiment of a midsole of the present invention. FIG. 5 is an elevational cross-section taken along lines 5--5 of FIG. 8. FIG. 6 is a side elevation view wherein a midsole is flexed along a forefoot portion. FIG. 7 is a detail of a side elevation view of a preform heel portion of a midsole of the present invention. FIG. 8 is a detail of a side elevation view of a heel portion of a midsole of the present invention. FIG. 9 is a bottom perspective view of a midsole of an alternative embodiment of the present invention. FIG. 10 is a side elevation view of the midsole and further showing an attached outer sole. FIG. 11 is a top plan view of an alternative embodiment of the midsole of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows a midsole 10 of the present invention in its preferred environment as a midsole for an athletic shoe 12 to be worn by a runner or the like. Typically, the shoe 12 is attached to the runner's foot by a lacing system 14. With reference to FIGS. 2-8, a preferred embodiment of the midsole 10 is shown as a one-piece, injection-molded elastomer having a top surface 16, a bottom surface 18, and a plurality of structural webs 20 that extend between the top surface 16 and the bottom surface 18. Preferably, the structural webs 20 form a tubular structure that is integrally formed with the top and bottom surfaces. Conceptually, the midsole 10 can be divided into a forefoot section 22 and a heel section 24. Preferably, the structural webs 20 along the heel section 24 form heel tubes 26 that extend inward from a medial edge 28 and from a lateral edge 30. As best shown in FIG. 4, a preferred embodiment of the present invention has discontinuous heel tubes 26 that extend from the medial and lateral edges 28 and 30, respectively, toward a central region 32 of the midsole having no tubes therein. The central region is bounded by heel tubes 26, bottom surface 18 and top surface 16. Further, in the heel section 24, the bottom surface 18 forms a "U"-shaped surface having legs 34 and 36 that extend from a rear tip 38 of the midsole toward the forefoot section 22. Associated with each leg 34, 36 is a width 34', 36', the significance of which will be explained below. Other embodiments of the heel section 24 may include heel tubes 26 that are continuous between the medial and lateral edges 28, 30, in which the case the bottom surface 18 would extend substantially over the heel section 24 and there would be no tubeless central region 32. The forefoot section 22 similarly comprises the integrally formed top surface 16, bottom surface 18 and intermediate structural webs 20. As with the heel section, the structural webs 20 preferably form elongate tubular members 40, hereinafter referred to as the forefoot tubes 40. In the preferred embodiment the forefoot tubes 40 have slit-shaped openings 42 that extend along the length of the forefoot tubes. The openings 42 permit substantial longitudinal flexibility in the forefoot section 22. In FIG. 6, the midsole 10 is shown with the forefoot section 22 flexed, and the slit openings 42 are shown spread open from their relaxed state. Substantial flexibility of the forefoot section along its longitudinal direction is a desirable property so that the athletic shoe 12 does not inhibit the natural tendency of the foot to roll from the heel onto the ball of the foot and onto the toe for push-off as the runner goes through a stride. The bottom surface is discontinuous at the openings 42. In a preferred embodiment shown in FIG. 4, the forefoot tubes 40 extend continuously from the medial edge 28 to the lateral edge 30. In an alternative embodiment, shown in FIG. 9, the forefoot tubes 40 are discontinuous between the medial and lateral edges, thereby forming a central forefoot region 44 having no tubes therein. The bottom surface 18 forms a "U"-shaped surface around the central forefoot region 44 thus forming legs 46 and 48 having widths 46' and 48', respectively. The significance of the leg widths 46', 48' will be explained below. By forming the tubeless central forefoot region, the forefoot section becomes more flexible laterally. Preferably, the entire midsole is injection molded as one integral piece of an elastomer having a tensile characteristic such that the ratio of plastic strain to elastic strain is greater than 1.5 to 1. One such elastomer is a copolyester polymer elastomer manufactured and sold by E. I. dupont de Nemours under the trademark HYTREL. HYTREL is reasonably inert and significantly, it is quite durable. Moreover, HYTREL is not subject to tear propagation even when made in relatively thin cross-sections. The preferred embodiments of the midsole use duPont's HYTREL composition number 5556. For a more complete description of this elastomer, see U.S. Pat. No. 4,198,037 and references cited therein. U.S. Pat. No. 4,198,037 is hereby incorporated herein by reference. As noted, the midsole 10 is preferably injection molded of HYTREL. It is well known that HYTREL will take a compression set. For this reason, the midsole of the present invention is molded into a preform and is subsequently compressed to take that set. As is taught in U.S. Pat. No. 5,280,890, compression of the HYTREL material also results in orientation of the molecular structure and enhances the spring characteristics of the material. The effect of this compression is illustrated in FIGS. 7 and 8. FIG. 7 illustrates the preform configuration, wherein the heel tubes 26 have been preformed into an oval cross-section so the tubes 26 are "tall,+ thereby providing a greater separation between the top surface 16 and the bottom surface 18. After the preform has been removed from the mold and annealed at room temperature for up to 24 hours. It is then compressed, preferably to a solid position. That is, the top surface 16 is pressed toward the bottom surface 18 thus radially compressing the heel tubes 26 and forefoot tubes 40. The midsole is compressed until it is "solid," wherein further force will not further move the surfaces together. Upon release of the compressive force, the tubes 26, 40 will partially spring back to a somewhat circular configuration as shown in FIG. 8. The midsole takes a "set" in this position. Thereafter, the tubes 26, 40 may be partially compressed during use by the runner, but as the runner's weight is removed, the springs will completely return to their set configuration, such as is shown in FIG. 8. A complete description of the compression set procedure is provided in U.S. Pat. No. 5,280,890, which is hereby incorporated by reference. The heel tubes 26 and the forefoot tubes 40 have the characteristics of springs and therefore have a measurable spring constant. It has not yet been determined whether the spring constant for the tubes of the present invention is a constant, or a function of the amount of compressive travel of the tubes. Furthermore, it has not yet been determined what the proper spring constant would be for the various configurations disclosed herein. However, it is known that various modifications to the configurations disclosed herein will affect the spring constant of the so that the midsole 10 can be designed for particular types and weights of runners after empirical data has been collected. The spring constant of the tubes can be increased by providing a longer tube. When the midsole 10 is loaded, the surfaces 16, 18 will move towards one another, thereby radially compressing the tubes under the given load. Obviously, a one-inch tube will radially compress more than a two-inch tube in length under the same load. Thus, the longer tube will have a higher spring constant. In the context of an athletic shoe, the higher spring constant means that the tube will provide greater stability but less cushioning. The tubes 26, 40 have wall thicknesses 50 and 52, respectively which also affect the spring constants. A thicker wall thickness 50 or 52 will produce a higher spring constant. In the preferred embodiment of the present invention, the wall thickness of a particular heel tube 26 is constant along the length of the tube. The wall thickness of the forefoot tubes 40 varies between the medial edge 28 and the lateral edge 30, preferably in a step-wise fashion, wherein the wall thickness would be a constant along a portion of the forefoot tube 40, and the wall thickness would jump to a different thickness at some point along the length of the tube. Alternatively, it is envisioned that any of the tubes could be provided with a tapering wall thickness wherein the wall thickness changes gradually from one end to the other of a particular tube. The preferred embodiment includes a two-stage spring constant in the heel section 24. The heel tubes 26 have a spacing 27 between the opposite walls of adjacent tubes. The spacing 27 is chosen so that those opposing walls touch as the tubes 26 are compressed. Further compression causes the tubes to press against each other thereby limiting the motion of the tube walls and changing the spring constant for further loading. Thus, the heel tubes 26 have an initial spring constant at the onset of compression and after the opposing walls of adjacent tubes make contact, the tubes have a different, higher spring constant. It is envisioned that the ability to control the spring constants can be used in various combinations to precisely control the performance characteristics of the midsole. For example, in a preferred embodiment of the present invention, the heel tubes 26 are provided with a constant wall thickness, but the width 36' of the lateral leg 36 could be less than the corresponding width 34', thereby placing shorter tubes 26 on the lateral side 30 as compared to the tubes on the medial side 28. This configuration would create a shoe having a higher spring constant along its medial edge to resist over pronation. In a preferred embodiment, the width 36' is approximately 24 mm and the width 34' is approximately 26 mm. Furthermore, the spring constant of the forefoot tubes 40 may be tailored by providing thicker wall sections in the tubes 40 in the regions proximate the medial edge 30 as compared to the wall thickness of the tubes 40 in the region close to the lateral edge 28. The varying wall thicknesses can be incorporated into the embodiments shown in FIG. 4 and FIG. 9. As is shown in FIG. 5, the heel tubes 26 are provided with beveled ends 26' so that the transverse width of the bottom surface 18 is greater than the transverse width of the top surface 16 at any particular point along the longitudinal length of the midsole 10. By providing a wider bottom surface, the midsole is able to provide greater stability for the athletic shoe 12. In the preferred embodiment of the present invention, the midsole 10 is provided with an outer sole 54, which is affixed to the bottom surface 18. Preferably, the outer sole 54 is made of a material having a high scuff resistance and substantial durability. Preferably, the outer sole 54 is provided with expansion joints 56 that cover one or more of the slit openings 42, thereby allowing the forefoot section to flex and permitting the slit openings to expand. An alternative embodiment may include the midsole of the present invention fabricated into two sections. As shown in FIG. 11, the two sections would comprise a forefoot section 58 and a rearfoot section 60. Making the midsole 10 into two sections provides numerous advantages. It may be possible to cut down on the number of molds necessary to provide midsoles for the full range of shoe sizes. For example, it may be possible to provide three different sizes of heel sections 60, while providing five different sizes of forefoot sections 58. The various sections can be mixed to provide the full range of shoe sizes. Also, by providing a midsole in two sections, it is possible to design sections to meet specific performance requirements. For example, a rearfoot section 60 may be designed for a size 9, 150-pound runner having a substantial over pronation problem, and another heel section 60 may be designed for a size 9, 150-runner who under pronates. Likewise, the spring constants in the forefoot section 58 can be specifically tailored to different runners and performance characteristics. The optimum values for the design parameters stated herein will be determined after extensive empirical data is collected. At present, the specific design parameters, such as, for example, optimum heel tube thickness and length for an over-pronating, 150 pound runner are unknown, and it is envisioned that physical testing will be necessary to determine such parameters. Numerous characteristics and advantages of the invention have been set forth in the foregoing description, together with details of the structure and function of the invention. The novel features hereof are pointed out in the appended claims. The disclosure is illustrative only, and changes may be made in detail, especially in matters of shape, size, and arrangement of parts within the principle of the invention to the full extent indicated by the broad general meaning of the terms in the claims.

1a

This is a continuation of U.S. application Ser. No. 10/411,743, filed Apr. 11, 2003 now U.S. Pat. No. 6,796,992, which is a continuation of U.S. application Ser. No. 09/531,443, filed Mar. 20, 2000, now U.S. Pat. No. 6,635,046, which is a divisional of U.S. application Ser. No. 09/260,371, filed Mar. 1, 1999, now U.S. Pat. No. 6,231,551. All of the above patents and applications are incorporated herein by reference in their entirety. FIELD OF THE INVENTION The present invention relates generally to medical devices. More particularly, the invention relates to methods and devices for augmenting blood flow to a patient's vasculature. More particularly, the invention relates to apparatus and methods which provide partial obstruction (“coarctation”) to aortic blood flow to augment cerebral perfusion in patients with global or focal ischemia. The devices and methods also provide mechanisms for continuous constriction and variable blood flow through the aorta. BACKGROUND OF THE INVENTION Patients experiencing cerebral ischemia often suffer from disabilities ranging from transient neurological deficit to irreversible damage (stroke) or death. Cerebral ischemia, i.e., reduction or cessation of blood flow to the central nervous system, can be characterized as either global or focal. Global cerebral ischemia refers to reduction of blood flow within the cerebral vasculature resulting from systemic circulatory failure caused by, e.g., shock, cardiac failure, or cardiac arrest. Shock is the state in which failure of the circulatory system to maintain adequate cellular perfusion results in reduction of oxygen and nutrients to tissues. Within minutes of circulatory failure, tissues become ischemic, particularly in the heart and brain. The most common form of shock is cardiogenic shock, which results from severe depression of cardiac performance. The most frequent cause of cardiogenic shock is myocardial infarction with loss of substantial muscle mass. Pump failure can also result from acute myocarditis or from depression of myocardial contractility following cardiac arrest or prolonged cardiopulmonary bypass. Mechanical abnormalities, such as severe valvular stenosis, massive aortic or mitral regurgitation, acutely acquired ventricular septal defects, can also cause cardiogenic shock by reducing cardiac output. Additional causes of cardiogenic shock include cardiac arrhythmia, such as ventricular fibrillation. Treatment of global cerebral ischemia involves treating the source of the systemic circulatory failure and ensuring adequate perfusion to the central nervous system. For example, treatment of cardiogenic shock due to prolonged cardiopulmonary bypass consists of cardiovascular support with the combination of inotropic agents such as dopamine, dobutamine, or amrinone and intra-aortic balloon counterpulsation. Vasoconstrictors, such as norepinephrine, are also administered systemically to maintain systolic blood pressure (at approximately above 80 mmHg). Unfortunately, these agents produce a pressure at the expense of flow, particularly blood flow to small vessels such as the renal arteries. The use of the vasoconstrictors is, therefore, associated with significant side effects, such as acute renal failure. Focal cerebral ischemia refers to cessation or reduction of blood flow within the cerebral vasculature resulting from a partial or complete occlusion in the intracranial or extracranial cerebral arteries. Such occlusion typically results in stroke, a syndrome characterized by the acute onset of a neurological deficit that persists for at least 24 hours, reflecting focal involvement of the central nervous system and is the result of a disturbance of the cerebral circulation. Other causes of focal cerebral ischemia include vasospasm due to subarachnoid hemorrhage or iatrogenic intervention. Traditionally, emergent management of acute ischemic stroke consists of mainly general supportive care, e.g. hydration, monitoring neurological status, blood pressure control, and/or anti-platelet or anti-coagulation therapy. Heparin has been administered to stroke patients with limited and inconsistent effectiveness. In some circumstances, the ischemia resolves itself over a period of time due to the fact that some thrombi get absorbed into the circulation, or fragment and travel distally over a period of a few days. In June 1996, the Food and Drug Administration approved the use of tissue plasminogen activator (t-PA) or Activase®, for treating acute stroke. However, treatment with systemic t-PA is associated with increased risk of intracerebral hemorrhage and other hemorrhagic complications. Aside from the administration of thrombolytic agents and heparin, there are no therapeutic options currently on the market for patients suffering from occlusion focal cerebral ischemia. Vasospasm may be partially responsive to vasodilating agents. The newly developing field of neurovascular surgery, which involves placing minimally invasive devices within the carotid arteries to physically remove the offending lesion may provide a therapeutic option for these patients in the future, although this kind of manipulation may lead to vasospasm itself. In both global and focal ischemia, patients develop neurologic deficits due to the reduction in cerebral blood flow. Treatments should include measures to increase blood flow to the cerebral vasculature to maintain viability of neural tissue, thereby increasing the length of time available for interventional treatment and minimizing neurologic deficit while waiting for resolution of the ischemia. Augmenting blood flow to the cerebral vasculature is not only useful in treating cerebral ischemia, but may also be useful during interventional procedures, such as carotid angioplasty, stenting or endarterectomy, which might otherwise result in focal cerebral ischemia, and also cardiac procedures which may result in global cerebral ischemia, such as cardiac catheterization, electrophysiologic studies, and angioplasty. New devices and methods are thus needed for augmentation of cerebral blood flow in treating patients with either global or focal ischemia caused by reduced perfusion, thereby minimizing neurologic deficits. SUMMARY OF THE INVENTION The invention provides vascular constriction devices and methods for augmenting blood flow to a patient's cerebral vasculature, including the carotid and vertebral arteries. The devices constructed according to the present invention comprise a constricting mechanism distally mounted on a catheter for delivery to a vessel, such as the aorta. The constrictor is collapsed to facilitate insertion into and removal from the vessel, and expanded during use to restrict blood flow. When expanded, the constrictor has a maximum periphery that conforms to the inner wall of the vessel, thereby providing a sealed contact between it and the vessel wall. The constrictor typically has a blood conduit allowing blood flow from a location upstream to a location downstream. The devices further include a variable flow mechanism in operative association with the blood conduit, thereby allowing blood flow through the conduit to be adjusted and controlled. The devices can optionally include a manometer and/or pressure limiter to provide feedback to the variable flow mechanism for precise control of the upstream and downstream blood pressure. Other medical devices, such as an infusion, atherectomy, angioplasty, hypothermia catheters or devices (selective cerebral hypothermia with or without systemic hypothermia, and typically hypothermia will be combined with measures to increase perfusion to overcome the decreased cerebral blood flow caused by the hypothermia, such that hypothermia and coarctation are complimentary), or electrophysiologic study (EPS) catheter, can be introduced through the constrictor to insert in the vessel to provide therapeutic interventions at any site rostrally. In a preferred embodiment, the expandable constrictor comprises an outer conical shell and an inner conical shell. Each shell has an apex and an open base to receive blood flow. One or a plurality of ports traverses the walls of the two conical shells. Blood flows through the open base and through the ports. The inner shell can be rotated relative to the outer shell so that the ports align or misalign with the ports in the outer shell to allow variable blood flow past the occluder, thereby providing adjustable and controlled flow. The inner shell is rotated by a rotating mechanism, e.g., a torque cable disposed within the elongate tube and coupled to the inner shell. The constrictor can be expanded by, e.g., a resilient pre-shaped ring, graduated rings, or a beveled lip formed at the base of the shell, and collapsed by, e.g., pull wires distally affixed to the occluder or a guide sheath. In another embodiment, the outer conical shell includes a plurality of resilient flaps, which are pivotally affixed to the base or the apex and can be displaced to variably control blood flow through the conduit. The flaps can be displaced by a plurality of pull wires affixed to the flaps. In still another embodiment, the constrictor comprises a first cylindrical balloon mounted to a distal end of the catheter, and a second toroidal balloon disposed about the cylindrical balloon. The chamber of the first balloon communicates with an inflation lumen. Blood flow occurs through the cylindrical balloon and through the center of the toroidal balloon. The toroidal balloon is expanded by inflation through a second and independent inflation lumen to reduce blood flow through the cylindrical balloon. In this manner, the first balloon provides an inflatable sleeve and the second toroidal balloon provides variable control of blood flow through the sleeve. Other embodiments include an expandable sleeve (not a balloon) surrounded by a toroidal balloon for adjustably constricting the flow of blood through the cylindrical sleeve. In a preferred method, the occlusion devices described above are inserted into the descending aorta through an incision on a peripheral artery, such as the femoral, subclavian, axillary or radial artery, in a patient suffering from global or focal cerebral ischemia, during cardiac surgery (including any operation on the heart, with or without CPB), or during aortic surgery (during circulatory arrest, as for aortic arch surgery, repair of an abdominal aortic aneurysm, or thoracic aneurysm repair, to reduce perfusion and the amount of blood loss in the operating field). The devices can be introduced over a guide wire. With assistance of transesophageal echocardiography (TEE), transthoracic echocardiography (TTE), intravascular ultrasound (IVUS), aortic arch cutaneous ultrasound, or angiogram, the constrictor is positioned downstream from the takeoff of the brachiocephalic artery and upstream from the renal arteries. The constrictor is expanded to partially occlude blood flow in the aorta and maintained during systole, during diastole, or during systole and diastole. The constrictor preferably achieves continuous apposition to the wall of the vessel, resulting in fewer emboli dislodgment. The pressure limiter, connected to the rotary unit and the pressure monitor, prevents the upstream and downstream blood pressure from exceeding, respectively, a set maximum and minimum pressure differential. Flow rates can be varied within one cardiac cycle (e.g., 80% during systole, 20% during diastole, or 70% during systole, 30% during diastole), and every few cycles or seconds (e.g., 80% for 6 cycles, 20% for 2 cycles, or 70% for 5 cycles, 10% for 1 cycle). In certain cases it may be preferred to cycle to cycle between lesser and greater occlusion so that the brain does not autoregulate. This ensures constant and continued increased cerebral perfusion. In this manner, blood in the descending aorta is diverted to the cerebral vasculature, thereby increasing cerebral perfusion and minimizing neurological deficits. By selectively increasing cerebral blood flow, the use of systemically administered vasoconstrictors or inotropic agents to treat shock may be reduced or eliminated. In another method, in patients anticipating a major cardiothoracic surgery, such as abdominal aortic aneurysm repair, the device is introduced and deployed approximately 24 hours prior to surgery, thereby inducing mild artificial spinal ischemia. This induces endogenous neuroprotective agents to be released by the spinal cord and/or brain in response to the ischemia, thereby protecting the tissue from ischemic insult of surgery. This technique is known as “conditioning”. The devices are inserted into the descending aorta. To induce spinal ischemia, the constrictor is positioned downstream from the takeoff of the brachiocephalic artery and upstream from the renal artery and expanded to partially occlude blood flow in the aorta, resulting in reduction of blood flow to the spinal cord. A similar technique may be employed to condition the brain to stimulate production of neuroprotective agents. To induce cerebral ischemia, the constrictor is positioned upstream from the takeoff of the innominate artery, or between the innominate artery and the left common carotid artery. Prolonged hypertension often causes ischemic damage to the kidneys. In still another method, the partial occlusion devices are introduced peripherally and positioned in the renal arteries to reduce blood pressure to the renal vasculature, thereby minimizing damage to the kidneys that might otherwise result from hypertension. It will be understood that there are many advantages in using the partial aortic occlusion devices and methods disclosed herein. For example, the devices can be used (1) to provide variable partial occlusion of a vessel; (2) to augment and maintain cerebral perfusion in patients suffering from global or focal ischemia; (3) to condition the brain or spinal cord to secrete neuroprotective agents prior to a major surgery which will necessitate reduced cerebral or spinal perfusion; (4) to prolong the therapeutic window in global or focal ischemia; (5) to accommodate other medical devices, such as an atherectomy catheter; (6) prophylactically by an interventional radiologist, neuroradiologist, or cardiologist in an angiogram or fluoroscopy suite; (7) for prevention of cerebral ischemia in patients undergoing procedures, such as coronary catheterization or surgery, where cardiac output might fall as a result of arrhythmia, myocardial infarction or failure; (8) to treat shock, thereby eliminating or reducing the use of systemic vasoconstrictors; and (8) to prevent renal damage in hypertensives. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a patient's systemic arterial circulation relevant to the present invention. FIG. 2 illustrates an embodiment of the devices constructed according to the present invention for providing partial occlusion of a vessel. FIG. 3 illustrates a constrictor of the device depicted in FIG. 2 . FIG. 4A illustrates an outer conical shell employed in the constrictor of FIG. 3 . FIG. 4B illustrates an inner conical shell employed in the constrictor of FIG. 3 . FIG. 5 illustrates an alternative embodiment of the constrictors of FIG. 3 having elongate rectangular ports. FIG. 6 illustrates another embodiment of the occluder having a beveled lip. FIG. 7 illustrates another embodiment of the occluder having a plurality of graduated rings. FIG. 8 illustrates complete misalignment of the ports on the outer and inner conical shells. FIG. 9 illustrates partial alignment of the ports on the outer and inner conical shells. FIG. 10 illustrates complete alignment of the ports on the outer and inner conical shells. FIG. 11 illustrates another embodiment of the device for providing partial occlusion of a vessel. FIG. 12 illustrates another embodiment of the constrictor employed in the device of FIG. 11 . FIG. 13A illustrates a frontal view of the constrictor of FIG. 12 having a plurality of preformed flaps extending perpendicular to the longitudinal axis of the constrictor. FIG. 13B illustrates a frontal view of the flaps of FIG. 13A under an external force. FIG. 13C illustrates a frontal view of the constrictor of FIG. 12 having a plurality of preformed flaps extending parallel to the longitudinal axis of the constrictor. FIG. 13D illustrates a frontal view of the flaps of FIG. 13C under an external force. FIG. 14 illustrates another embodiment of the occluder having flaps included in the collar of the outer conical shell. FIG. 15 illustrates still another embodiment of the device for providing partial occlusion of a vessel. FIG. 16 illustrates an embodiment of the constrictor employed in the device of FIG. 15 . FIG. 17 illustrates the constrictor of FIG. 16 , having an inflated ring-shaped balloon for reducing blood flow through a blood conduit. FIG. 18 illustrates the occluder of FIG. 16 , having a deflated ring-shaped balloon. FIG. 19 illustrates a suction/atherectomy catheter introduced through the constrictor of FIG. 16 . FIG. 20 illustrates a perfusion and an EPS catheter introduced through the constrictor of FIG. 16 . FIG. 21A illustrates the constrictor of FIG. 3 inserted in the aorta downstream from the left subclavian artery and partially occluding aortic blood flow. FIG. 21B illustrates the constrictor of FIG. 14 inserted in the aorta downstream from the left subclavian artery and partially occluding aortic blood flow. FIG. 22 illustrates the constrictor of FIG. 3 inserted in the aorta downstream from the right brachiocephalic artery and partially occluding aortic blood flow. FIG. 23 illustrates a suction/atherectomy catheter introduced through the constrictor of FIG. 3 and inserted in the left carotid artery proximal to a thromboembolic occlusion. FIG. 24 illustrates the constrictor of FIG. 3 inserted in the aorta upstream from the lumbar or lumbar or spinal arteries. FIG. 25 illustrates the constrictor of FIG. 3 inserted in the renal arteries. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The devices and methods disclosed herein are most useful in treating patients suffering from global cerebral ischemia due to systemic circulatory failure, and focal cerebral ischemia due to thromboembolic occlusion of the cerebral vasculature. However, it will be understood that the devices and methods can be used in other medical conditions, such as hypertension and spinal cord conditioning. Systemic arterial circulation relevant to the methods of the present invention is described in FIG. 1 . During systole, oxygenated blood leaving heart 8 enters aorta 10 , which includes ascending aorta 12 , aortic arch 14 , and descending aorta 22 . The aortic arch gives rise to brachiocephalic trunk 16 , left common carotid artery 18 , and left subclavian artery 20 . The brachiocephalic trunk branches into right common carotid artery 24 and right subclavian artery 26 . The right and left subclavian arteries, respectively, give rise to right vertebral artery 28 and left vertebral artery 34 . The descending aorta gives rise to a multitude of arteries, including lumbar (i.e., spinal) arteries 38 , which perfuse the spinal cord, renal arteries 40 , which perfuse the kidneys, and femoral arteries 42 , which perfuse the lower extremities. FIG. 2 depicts occlusion catheter 100 for use in the methods described herein. The device includes elongate catheter 102 , distally mounted expandable constrictor, i.e., occluder, 104 having distal opening 124 and variable flow mechanism 108 . The constrictor, when expanded, has maximum periphery 110 , which conforms to the inner wall of a vessel to form a secure seal with the vascular wall, such that blood flow through the vessel can be effectively controlled. Opening 124 receives blood from distal the constrictor and controls the passage of blood proximal the constrictor. Variable flow mechanism 108 , connected to rotary unit 150 , operates the constrictor, thereby controlling (1) the flow rate through the occlusion, and (2) upstream blood pressure. Preferably, the device includes manometer 112 , which is connected to pressure monitor 156 and pressure limiter 114 . Rotary unit 150 receives blood pressure measurements from the manometer. Pressure limiter 114 , connected to the rotary unit and the pressure monitor, prevents the upstream and downstream blood pressure from exceeding, respectively, a set maximum and minimum pressure differential. A proximal end of the catheter is equipped with adapter 103 , from which pull wires 132 can be manipulated for collapsing the occluder and to which the rotary unit, pressure monitor, and/or pressure limiter can be connected. Referring to FIG. 3 , the occlusion device comprises catheter 102 and constrictor 104 . The catheter is constructed from a biocompatible and flexible material, e.g., polyurethane, polyvinyl chloride, polyethylene, nylon, etc. The catheter includes lumen 116 through which various operative elements pass. Alternatively, the catheter may include more than one lumen to support various operative elements. The catheter also includes proximal adapter 103 (see FIG. 2 ), which provides an interface between the catheter and the various instruments received by the catheter. The occluding mechanism consists of outer conical shell 118 and inner conical shell 136 , each having a distal open base and a proximal apex. Pre-shaped ring 130 is affixed to base 120 of the outer shell to facilitate expansion of the constrictor. The ring is formed of a resilient material, capable of expanding the occluder to achieve a maximum periphery, which is defined by the outer circumference of the ring. Ring 130 , may, in certain embodiments, further include an anchoring mechanism, such as hooks, bonded to the outer circumference of the ring. Expansion of the ring causes the grasping structure to engage the surface of the vessel wall, thereby securing the occluder and preventing displacement in the vessel due to force exerted by blood flow. In other embodiments, the anchoring is provided by an adhesive strip, vacuum, or merely by frictional engagement of the vessel lumen by the ring. The constrictor can be collapsed to facilitate insertion into and removal from a vessel. A plurality of pull wires 132 ( FIG. 2 ) are disposed within torque cable 148 , and are distally connected to base 120 of outer shell 118 and proximally passes through adapter 103 . The constrictor is collapsed by applying a tensile force on wires 132 , using torque cable 148 to provide leverage to the pull wires, thereby drawing the circumference of the open base 120 towards its center and collapsing the occluder. A guide sheath (not shown) can be alternatively used to collapse the constrictor. Using this technique, the guide sheath would cover the constrictor and be withdrawn to release the constrictor and advanced to collapse the constrictor. Opening 124 is formed in base 138 and 120 of the respective inner and outer conical shells to provide an inlet for blood flow. Conical interior 106 communicates with ports 128 of the outer shell. When the constrictor is deployed, blood flows into opening 124 , through interior 106 , and exits through ports 128 . The occluding mechanism comprises inner conical shell 136 (partially shown in phantom in FIG. 3 ), which is rotatably disposed within outer shell 118 as shown in FIGS. 8 , 9 , and 10 . The inner shell can be rotated relative to the outer shell through torque cable 148 , which is disposed in lumen 116 of catheter 102 . Manometer 112 comprises upstream pressure tube 152 and downstream pressure tube 154 , both connected proximally to a pressure monitor to provide respective blood pressure measurements upstream and downstream the constrictor. The upstream pressure tube extends distal to opening 124 , or may be attached to the inner shell. The downstream pressure tube extends through an orifice in the catheter proximal to the constrictor. The upstream and downstream blood pressure measurements are recorded and displayed by the pressure monitor at a proximal end of the catheter. A pressure limiter, programmed with a maximum pressure threshold to limit the upstream blood pressure and a minimum pressure threshold to limit the downstream blood pressure, is connected to the pressure monitor to receive pressure measurements therefrom, and transmits information to a rotary unit. The limiter thereby prevents the rotary unit from rotating the inner shell relative to the outer shell in a manner that would cause the upstream blood pressure to exceed the maximum threshold, or the downstream blood pressure to fall below the minimum threshold. Without the rotary unit, torque cable 148 can also be manually rotated to obtain desired upstream and downstream blood pressures. An audible alarm may be incorporated into the pressure limiter to sound when blood pressures exceeds the thresholds. The pressure limiter may further comprise an interlocking device. The interlocking device, in operative association with upstream and downstream tubes 152 and 154 , can lock inner shell 136 with respect to outer shell 118 as blood pressures approach the set thresholds. It should be noted that although the rotary unit, pressure monitor, and pressure limiter are shown as separate units, they may be incorporated into an integral unit. Referring to FIGS. 4A and 4B , the expanded constrictor comprises outer conical shell 118 having base 120 and apex 122 , and inner conical shell 136 having base 138 and apex 140 . The constrictor is preferably composed of a biocompatible material coated with heparin to prevent blood clotting. The conical shape of the expanded constrictor minimizes turbulence caused by placement of the occluder in the vessel. The outer and inner shells include 2, 3, 4, 5, 6, or any other number of ports 128 and 144 , respectively, in communication with the conical interior to permit blood flow through the occluder. The inner shell can be rotated relative to the outer shell, so that ports 144 communicate with ports 128 . Apices 122 and 140 of the respective outer and inner shells further comprise collar 126 and 142 . The collars may include engaging threads, so that collar 142 can be inserted and secured into collar 126 , and bonded to a distal end of the torque cable, such that the inner shell is coupled to and rotates with the torque cable. A rotary unit, preferably including a stepper motor (not shown), may be mechanically coupled to a proximal end of the torque cable to provide precise rotational position of the inner shell relative to the outer shell, thereby providing variable flow through the occluder. Instead of having the circular ports in the inner and outer shells as depicted in FIGS. 4A and 4B , the constrictor may include 2, 3, 4, 5, 6, or any other number of ports having other suitable geometric shapes. FIG. 5 depicts constrictor 104 having a plurality of ports constructed as elongate rectangular slots 175 . FIG. 6 depicts another embodiment of the constrictor, which comprises beveled lip 140 having distal end 142 and proximal end 141 . The proximal end is affixed to base 120 of the outer conical shell. The proximal end has a larger diameter than the distal end and is everted to prevent the constrictor from being displaced in the direction of blood flow, thereby securing the constrictor in the vessel. Still another embodiment of the occluder may includes 1, 2, 3, 4, 5, or any other number of graduated inflatable rings. In FIG. 7 , ring 151 is affixed to the base of the conical shell. Ring 153 , having the smallest inflated diameter, is attached to ring 152 , which is then attached to ring 151 , having the largest inflatable diameter. The fully inflated rings will have a thickness of approximately 2 to 3 millimeters. Similar to the beveled lip of FIG. 8 , the rings prevent the outer conical shell from being displaced in the direction of blood flow, thereby securing the constrictor in the vessel. The flow rate of blood through the constrictor can be easily controlled by rotating inner conical shell 136 (shown with dotted lines) relative to outer conical shell 118 as depicted in FIGS. 8 , 9 , and 10 . In FIG. 8 , the inner shell is rotated so that ports 144 and 128 are completely misaligned, thereby achieving no flow through the ports and complete vascular occlusion distally. As the inner shell is rotated clockwise relative to the second shell in FIG. 9 , ports 144 on the inner shell become partially aligned with ports 128 on the outer shell, thereby achieving partial flow through the ports and partial vascular occlusion. In FIG. 10 , with continuing clockwise rotation of the inner shell, ports 144 become completely aligned with ports 128 , thereby achieving maximum flow through the ports. To provide a broader and more predictable range of blood flow through the conduit, the ports of the inner and outer shells are preferably of equal size and number such that they may align with each other. FIG. 11 depicts another embodiment of the occlusion device for partial occlusion of blood flow in a vessel. Device 200 comprises elongate catheter 202 , distally mounted expandable constrictor 204 with maximum periphery 210 , opening 224 , and variable flow mechanism 208 operatively associated with the constrictor. The catheter includes adapter 203 at its proximal end. Preferably, the device includes manometer 212 and pressure limiter 214 , and pressure monitor 240 . The pressure monitor records and displays blood pressure data received from the manometer. Longitudinal positioning unit 208 , receiving signals from pressure limiter 214 , and controls variable flow mechanism 208 to provide variable blood flow through the constrictor. Referring to FIG. 12 , catheter 202 includes lumen 216 . Constrictor 204 comprises hollow conical shell 218 having base 220 and apex 222 . The inner circumference of the base forms opening 224 , which provides a distal inlet for blood flow through the constrictor. The inner circumference of apex 222 forms collar 228 with proximal opening 226 , which provide an outlet for blood flow through the constrictor. The conical interior, disposed within shell 218 , communicates with opening 224 distally and opening 226 proximally. When the base of the constrictor is positioned upstream in a vessel, blood flows into opening 224 , through the conical interior, and exits downstream through opening 226 . The catheter is bonded to collar 228 about a portion of its inner circumference. The constrictor is expanded by operation of ring 230 , a beveled lip, or a series of graduated toroidal balloons as described above. The constrictor is collapsed and may be delivered to a vessel location by using a guide sheath. The manometer comprises upstream pressure tube 236 and downstream pressure tube 238 , which are disposed in lumen 216 of the catheter and connected proximally to a pressure monitor. The upstream pressure tube extends distal from the constrictor or may be bonded to the inner surface of the conical shell, thereby providing upstream blood pressure measurement. The downstream pressure tube extends through an orifice in the catheter proximal to the constrictor, thereby providing downstream blood pressure measurement. The variable flow mechanism comprises a plurality of flaps 230 pivotally affixed to base 220 . The flaps are preferably made of a resilient material, such as Nitinol, to resist movement caused by blood flow through the conduit. A plurality of pull wires 232 , disposed through lumen 216 , are distally connected to flaps 230 , such that applying a tensile force to the wires pivotally displaces flaps 230 from their preformed position. Three of the flaps (shown in dotted lines) are displaced inward. Releasing the wires allows the resilient flaps to relax and return to their preformed position. The pull wires are coupled proximally to the longitudinal positioning unit, which provides precise displacement of the flaps relative to opening 224 . Alternatively, wires 232 can be manually tensed to operate the flaps. The pressure limiter receives pressure measurements from the pressure monitor and transmits signals to the longitudinal positioning unit to prevent the upstream and downstream blood pressures from exceeding the set thresholds. FIGS. 13A , 13 B, 13 C, and 13 D depict frontal views of the constrictor having flaps in various positions for controlling blood flow. In FIG. 13A , preformed flaps 230 extend radially inward toward the longitudinal axis of the catheter, as in the absence of a displacing force, i.e., an external force other than that created by blood flow. When the constrictor is positioned in the descending aorta, for example, the size of opening 224 and blood flow through the opening is minimized, thereby providing maximal aortic occlusion. In the presence of a displacing force, such as pulling the wires to displace flaps 230 from their preformed position as depicted in FIG. 13B , the size of aperture 224 and blood flow through the conduit increases, thereby providing partial aortic occlusion. Alternatively, preformed flaps 230 extend parallel to the longitudinal axis of opening 224 in the absence of a displacing force as depicted in FIG. 13C . The size of opening 224 and blood flow through the conduit are maximized, thereby providing minimal blood flow occlusion. In the presence of a displacing force, flaps 230 are pivotally displaced from their preformed position as depicted in FIG. 13D . The size of opening 224 and blood flow through the opening are minimized, thereby providing maximal blood flow occlusion. Thus, by pivotally displacing flaps 230 relative to opening 224 , the size of the opening and flow rate through the constrictor is controlled to provide variable vessel occlusion. The constrictor shown in FIG. 12 can be alternatively mounted on catheter 202 , such that base 220 is proximal to apex 222 as shown in FIG. 14A . In this embodiment, flaps 230 are formed on open apex 222 . When constrictor 204 is inserted downstream in the aorta, for example, pressure tube 238 extends distally from opening 226 to provide downstream blood pressure measurements, whereas pressure tube 236 extends proximally through an orifice in the catheter to provide upstream blood pressure measurements. In FIG. 15 , another embodiment of the device comprises catheter 302 , a distally mounted occluder 304 with maximum periphery 310 , blood passage 306 disposed within the constrictor, and variable flow mechanism 308 in operative association with the blood conduit. Inflation device 334 communicates with the constrictor, and inflation device 338 communicates with the variable flow mechanism. The device preferably includes proximal adapter 303 , manometer 312 , and pressure limiter 314 . Pressure monitor 312 records and displays blood pressure data from the manometer. The pressure limiter is connected to the pressure monitor and to an interlocking valve on inflation device 338 , such that the blood pressure upstream and downstream the constrictor can be controlled to prevent from exceeding set thresholds. Referring to FIG. 16 , constrictor 304 is mounted to a distal end of catheter 302 having lumen 316 . The constrictor comprises a sleeve or cylindrical balloon 318 having outer wall 320 and inner wall 322 , which enclose chamber 323 . The cylindrical balloon has first end 324 with opening 328 and second end 326 with opening 330 . Catheter 302 is bonded to inner wall 322 of the cylindrical balloon. Inflation tube 332 , housed within lumen 316 of the catheter, communicates distally with the cylindrical balloon and proximally with a syringe or other inflation device. The cylindrical balloon can be expanded or collapsed by injecting or removing air, saline, or other medium. Occlusion is provided by toroidal balloon 334 disposed about the outer or inner surface of sleeve 318 and communicating with inflation tube 336 and a syringe. The inflation device may include an interlocking valve to prevent unintended deflation. Lumen 306 communicates with opening 328 distally and opening 328 proximally. When deployed in a vessel, blood flows through lumen 306 and exits downstream opening 330 . The constrictor may further include an anchoring structure, shown in FIG. 16 as rings 333 , which are disposed about outer wall 320 of the cylindrical sleeve and define maximum periphery 310 of the occluder. Manometer 312 comprises upstream pressure tube 340 and downstream pressure tube 342 , which are operatively connected proximally to a pressure monitor. Pressure tube 340 is bonded to the lumen of the cylindrical balloon and extends distal to provide upstream blood pressure measurements, while tube 342 emerges from the catheter proximal the occluder to provide downstream blood pressure measurements. In FIG. 17 , fluid is injected to expand balloon 334 , thereby constricting sleeve 318 . As a result, blood flow is constricted. In FIG. 18 , balloon deflation allows sleeve 318 to revert back to its pre-shaped geometry, increasing blood flow therethrough. Thus, balloon 334 can be inflated and deflated to vary the cross-sectional diameter of lumen 306 to vary flow rate. The occlusion devices described herein can be employed with a variety of therapeutic catheters to treat vascular abnormalities. For example, as depicted in FIG. 19 , suction/atherectomy catheter 402 can be inserted through lumen 306 , such that the suction/atherectomy catheter is independently movable relative to occlusive device 300 . Catheter 402 includes elongate tube 404 and distally located aspiration port 406 , cutting device 408 , and balloon 410 for removing thromboembolic material in a vessel. In FIG. 20 , infusion catheter 502 and EPS catheter 504 are inserted through opening 206 of occlusion device 200 , such that catheter 502 and 504 are independently movable relative to occlusion device 200 . The infusion catheter, which includes elongate tube 506 , distally located perfusion port 508 , and expandable balloon 510 , can be used to remove thromboembolic material in a vessel. EPS catheter 504 , which includes elongate tube 512 and distally located ablation device 514 , may be used to map out or ablate an extra conduction pathway in the myocardial tissue, e.g., in patients suffering from Wolff-Parkinson-White syndrome. The occlusion device, capable of augmenting cerebral perfusion, is therefore useful not only in facilitating definitive treatment but also in cerebral ischemia prevention during EPS and other cardiac interventions or cardiac surgery, such as coronary catheterization, where sudden fall in cerebral blood flow may occur due to arrhythmia, myocardial infarction, or congestive heart failure. Referring to FIG. 21A , occlusion device 100 described above can be used to partially occlude blood flow in aorta 10 of a patient suffering from global cerebral ischemia due to, e.g., septic shock, congestive heart failure, or cardiac arrest. Constrictor 104 can be introduced in its collapsed geometry through an incision on a peripheral artery, such as the femoral, subclavian, axillary, or radial artery, into the patient's aorta. A guide wire may first be introduced over a needle, and the collapsed constrictor is then passed over the guide wire and the needle to position distal to the takeoff of left subclavian artery 20 in the descending aorta. The constrictor is expanded, such that maximum periphery 110 of the occluder, formed by expandable ring 130 , sealingly contacts the inner aortic wall. The position and orientation of the collapsed or expanded device can be checked by TEE, TTE, aortic arch cutaneous ultrasound in the emergency room, or IVUS and angiography in the angiogram suite. The expanded constrictor is maintained during systole, during diastole, or during systole and diastole, during which blood distal to the brachiocephalic artery is forced to pass through opening 106 , thereby providing a continuous partial occlusion of aortic blood flow. Alternatively, partial occlusion of aortic blood flow can be intermittent. As a result, blood flow to the descending aorta is partially diverted to brachiocephalic artery 16 , left subclavian artery 20 , and left carotid artery 18 , thereby augmenting blood flow to the cerebral vasculature. In treating global ischemia, such as in shock, cerebral perfusion is increased by increasing blood flow through both carotid and vertebral arteries. Additionally, blood flow to the aorta is partially diverted to the coronary arteries by using the occlusion device, thereby augmenting flow to the coronary arteries. Using the partial occlusion methods during systemic circulatory failure may, therefore, improve cardiac performance and organ perfusion. By selectively increasing cerebral and coronary blood flow in this manner, the dosage of commonly used systemic vasoconstrictors, such as dopamine and norepinephrine, may be reduced or eliminated. Alternatively, the device of FIG. 14 , much like the device used to extinguish the flame of a candle, can be introduced through an incision on left subclavian artery 36 as depicted in FIG. 21B . Constrictor 204 is inserted in aorta 22 distal to the takeoff of the left subclavian artery to provide partial, variable, and/or continuous aortic occlusion and is advanced antegrade into the descending aorta. This device is particularly useful in situations where peripheral incision can not be made on the femoral arteries due to arteriosclerosis, thrombosis, aneurysm, or stenosis. The devices and methods described in FIGS. 21A and 21B are useful in treating stroke patients within few minutes of stroke symptom, and the treatment can be continued up to 96 hours or more. For example, in treating focal ischemia due to a thromboembolic occlusion in the right internal carotid artery the constrictor may be position distal to the takeoff of the left subclavian. As a result, blood flow is diverted to brachiocephalic artery 16 and left CCA to augment both ipsilateral and contralateral collateral circulation by reversing direction of flow across the Circle of Willis, i.e., increasing flow in the right external carotid artery and left common carotid artery. The collateral cerebral circulation is further described in details in U.S. application Ser. No. 09/228,718, incorporated herein by reference. In treating focal ischemia due to a thromboembolic occlusion in the left internal carotid artery, for example, the constrictor can be positioned proximal to the takeoff of left carotid artery 18 and distal to the takeoff of brachiocephalic artery 16 as shown in FIG. 22 . Contralateral collateral enhancement is provided by increasing flow through the brachiocephalic artery, thereby reversing blood flow in the right posterior communicating artery, right PCA, left posterior communicating artery 68 and anterior communicating artery, resulting in increased perfusion to the ischemic area distal to the occlusion and minimizing neurological deficits. Alternatively, the constrictor may be positioned distal to the takeoff of the left subclavian artery to provide both ipsilateral and contralateral collateral augmentation. Ipsilateral circulation is enhanced by increasing flow through the left external carotid artery and reversing flow along the left ophthalmic artery, both of which contribute to increased flow in the left ICA distal to the occlusion. As a result of partially occluding aortic blood flow, blood pressure distal to the aortic occlusion may decrease, and this may result in a reduction in renal output. Blood pressure proximal the aortic occlusion will increase and may result in excessive rostral hypertension. The blood pressures, measured by the manometer, are monitored continuously, and based on this information the occlusion is adjusted to avoid peripheral organ damage. After resolution of the cerebral ischemia, the constrictor is collapsed and removed, thereby removing the aortic occlusion and restoring normal blood flow in the aorta. In FIG. 23 , constrictor 304 is inserted in aorta 10 and can be used to remove thromboembolic material 72 from left common carotid artery 18 , while augmenting and maintaining cerebral perfusion distal to the occluding lesion. The occluder may be introduced through a guide sheath until it is positioned distal to left subclavian artery 20 . In emergency situations, the constrictor can be inserted through a femoral incision in the emergency room, and atherectomy/suction catheter 402 can be inserted through the constrictor under angioscopic vision in the angiogram suite after the patient is stabilized hemodynamically. The atherectomy/suction catheter, which includes expandable balloon 410 , distal aspiration port 406 , and atherectomy device 408 , is introduced through opening 306 until its distal end is positioned in left common carotid artery 18 proximal to the thromboembolic occlusion. Constrictor 304 is then expanded to partially occlude aortic blood flow, thereby increasing perfusion to the ischemic region distal to the occluding lesion by enhancing ipsilateral collateral flow through left external carotid artery 46 and left vertebral artery 34 and contralateral collateral flow to right carotid artery 24 and right vertebral artery 28 . The variable flow mechanism of constrictor 304 can be adjusted to control blood flow to the cerebral vasculature and the blood pressure. Balloon 410 of catheter 402 is expanded in the left common carotid artery, thereby creating a closed chamber between constrictor 410 and the thromboembolic occlusion. Suction can be applied to aspiration port 406 to create a negative pressure in the closed chamber, thereby increasing the pressure differential across the thromboembolic occlusion, which may dislodge the occluding lesion onto the aspiration port and remove the occluding lesion. Thromboembolic material 72 may be further removed by atherectomy device 408 . The methods herein can also be used to remove thromboembolic occlusion in the vertebral artery. The occlusion device 304 , therefore, not only augments cerebral perfusion in patients suffering from focal stroke or global ischemia, but also maintains cerebral perfusion while waiting for invasive or noninvasive intervention. The devices and methods of using atherectomy/suction catheter 102 are further described in U.S. application Ser. No. 09/228,718, incorporated herein by reference. During abdominal aortic aneurysm (AAA) surgery, lumbar or spinal arteries, which provide blood supply to the spinal cord, are often dissected away from the diseased abdominal aorta, resulting in reduction of blood flow to the spinal cord. The devices herein disclosed may be used to condition the spinal cord prior to AAA repair, thereby reducing the damage resulting from spinal ischemia during surgery. In FIG. 24 , constrictor 104 is inserted in aorta 10 and expanded preferably distal to left subclavian artery 20 and proximal to lumbar arteries 38 . As a result, blood flow to the lumbar or spinal arteries is reduced. When this device is used in patients anticipating a major thoracoabdominal surgery, such as AAA repair, approximately 24 hours prior to surgery, blood flow to the lumbar arteries can be intentionally reduced to induce mild spinal ischemia, thereby conditioning the spinal cord to produce neuroprotective agents which may protect the spinal cord from more significant ischemic insult during surgery. In hypertension, end organ damage often results, e.g., cardiac, renal, and cerebral ischemia and infarction. The devices and methods herein may be employed in hypertension to protect the kidneys from ischemic insult. In FIG. 25 , constrictors 104 , which can be introduced through a femoral artery, are inserted in right renal artery 80 and left renal artery 82 . The constrictors are expanded to partially occlude blood flow from descending aorta 10 to the renal arteries, thereby reducing blood pressure distal to the occlusion. The constrictors can be deployed for the duration of any systemic hypertensive condition, thereby protecting the kidneys from damage that might otherwise be caused by the hypertension. The length of the catheter will generally be between 20 to 150 centimeters, preferably approximately between 30 and 100 centimeters. The inner diameter of the catheter will generally be between 0.2 and 0.6 centimeters, preferably approximately 0.4 centimeters. The diameter of the base of the outer conical shell will generally be between 0.3 and 3.0 centimeters, preferably approximately 0.5 and 2.0 centimeters. The diameter of the inflated balloon occluder will generally be between 0.3 and 3.0 centimeters, preferably approximately 0.5 and 2.0 centimeters. The ports of the inner and outer conical shells will generally have a diameter of between 1 to 6 millimeters, preferably approximately 3 to 4 millimeters. The foregoing ranges are set forth solely for the purpose of illustrating typical device dimensions. The actual dimensions of a device constructed according to the principles of the present invention may obviously vary outside of the listed ranges without departing from those basic principles. Although the foregoing invention has, for the purposes of clarity and understanding, been described in some detail by way of illustration and example, it will be obvious that certain changes and modifications may be practiced which will still fall within the scope of the appended claims.

1a

TECHNICAL FIELD [0001] The present invention relates generally to ingestible capsules and, more particularly, to an ingestible capsule having interchangeable sensing components. BACKGROUND ART [0002] Ingestible capsules are well-known in the prior art. Such capsules are generally small pill-like devices that can be ingested or swallowed by a patient. It is known that such capsules may include one or more sensors for determining physiological parameters of the gastrointestinal tract, such as sensors for detecting temperature, pH and pressure. [0003] It is also known that certain physiological parameters may be associated with regions of the gastrointestinal tract. For example, a 1988 article entitled “Measurement of Gastrointestinal pH Profiles in Normal Ambulant Human Subjects” discloses pH measurements recorded by a capsule passing through the gastrointestinal tract. It is known that pH has been correlated with transitions from the stomach to the small bowel (gastric emptying) and from the distal small bowel to the colon (ileo-caecal junction). [0004] U.S. Patent Publication Number US2007/0118012 discloses an imaging device having two optical heads, and discloses that domes may be placed over the optical heads and into abutment with a connecting sleeve so that the connecting sleeve and the domes form a closed housing that defines the boundary surface of the in-vivo device. International Publication Number WO 2006/0077535 discloses a medicament dispensing capsule in which individual reservoirs may be provided in respective modules which are interlocking and connectable. International Publication Number WO 2006/0070374 discloses a system and method for assembling a swallowable sensing device, including attaching a first piece of a shell to a second piece of a shell, where the attachment may include, for example, screwing the first piece to the second piece, welding or gluing the first piece to the second piece, snapping the first piece to the second piece or applying laser energy to a pigment in the first piece. DISCLOSURE OF THE INVENTION [0005] With parenthetical reference to corresponding parts, portions or surfaces of the disclosed embodiment, merely for the purposes of illustration and not by way of limitation, the present invention provides a modular ingestible capsule ( 15 ) comprising a capsule body ( 16 ) having an outer shell ( 21 ), a power supply ( 22 ), a transmitter ( 23 ) connected with the power supply, an antenna ( 24 ) connected with the transmitter, an activator ( 25 ) configured to activate the power supply, and an electrical coupling element ( 26 ) connected with the transmitter, a first modular sensing component ( 18 ) configured and arranged to connect to the capsule body and having an outer shell ( 28 ) configured and arranged to attach to the shell of the capsule body, a sensor ( 29 ) for sensing a parameter of an ingestible tract, and an electrical coupling element ( 32 ) connected with the sensor and configured and arranged to engage the electrical coupling element of the capsule body, whereby the first modular sensing component may be readily mechanically and electrically attached to the capsule body prior to ingestion of the capsule by subject. [0006] The sensor may be selected of a group consisting of a pH sensor, a pressure sensor and a temperature sensor. The power supply may comprise a battery. The transmitter may be configured to transmit data to a remote receiver. The capsule body my further comprise a temperature sensor ( 27 ). The electrical coupling element of the capsule body may comprise a plug and the electrical coupling element of the modular sensing component may comprise a receptacle configured to receive the plug. The modular sensing component may further comprise a processor ( 31 ) connected with the sensor. The processor may be programmed to control the sampling rate of the sensor. The processor may be programmed to control the transmission burst duration and the rate of transmission bursts. The sensor may be an analog sensor ( 30 ) that provides an output voltage in response to stimuli. The modular sensing component may further comprise an analog-digital converter ( 41 ) configured to convert an analog signal from the sensor to a digital signal. The capsule body may further comprise a processor ( 74 ) connected with the electrical coupling element ( 75 ) of the body and the modular sensing component may further comprise an ID tag recognizable to the processor. [0007] The capsule may further comprise a second modular sensing component ( 20 ) configured and arranged to connect to the capsule body and having an outer shell ( 33 ) configured and arranged to attach to the shell of the capsule body, a sensor ( 30 ) for sensing a parameter of an ingestible tract, and an electrical coupling element ( 35 ) connected with the sensor and configured and arranged to engage the electrical coupling element of the capsule body, wherein the second modular sensing component may be interchangeably attached mechanically and electrically to the capsule body with the first modular sensing component. [0008] The capsule body ( 50 ) may comprise a second electrical coupling element ( 58 ) connected with the transmitter and the capsule may further comprise a second modular sensing component ( 20 ) configured and arranged to connect to the capsule body and having an outer shell ( 33 ) configured and arranged to attach to the shell ( 52 ) of the capsule body, a sensor ( 30 ) for sensing a parameter of the ingestible tract, and an electrical coupling element ( 35 ) connected with the sensor and configured and arranged to engage the second electrical coupling element of the capsule body, whereby the second modular sensing component may be mechanically and electrically attached to the capsule body prior to ingestion of the capsule by a subject. [0009] The sensor of the first modular sensing component may be different from the sensor of the second modular sensing component, and the sensor of the first modular sensor component may be a pH sensor ( 30 ) and the sensor of the second modular sensing component may be a pressure sensor ( 29 ). The sensor of the first modular sensing component may be the same as the sensor of the second modular sensing component, and the sensors may be pressure sensors. The transmitter may be connected directly to the power supply and the processor may communicate with the sensor bi-directionally. The electrical coupling element of the body may be connected to the power supply, and the electrical coupling element of the body may be connected directly to the power supply and the transmitter. [0010] In another aspect, the invention provides a method of measuring parameters of the gastrointestinal tract of a subject comprising the steps of providing a capsule body having an outer shell, a power supply, a transmitter connected to the power supply, an antenna connected with the transmitter, an activator configured to activate the power supply and an electrical coupling element connected with the transmitter, providing a first modular sensing component configured and arranged to connect to the capsule body and having an outer shell configured and arranged to attach to the shell of the capsule body, a sensor for sensing a parameter of an ingestible tract, and an electrical coupling element connected with the sensor and configured and arranged to engage the electrical coupling element of the capsule body, providing a second modular sensing component configured and arranged to connect to the capsule body and having an outer shell configured and arranged to attach to the shell of the capsule body, a sensor for sensing a parameter of an ingestible tract, and an electrical coupling element connected with the sensor and configured and arranged to engage the electrical coupling element of the capsule body, attaching one of the first or second modular sensing components to the capsule body, having a subject ingest the capsule, recording measurements from the sensor of the attached modular sensing component as the capsule passes through a gastrointestinal tract of the subject, and transmitting the measurements from a transmitter to a receiver located outside of the gastrointestinal tract of the subject. [0011] Accordingly, an object is to provide a modular capsule system in which different sensing components may be interchangeably used with a standard base component. [0012] Another object is to provide a method for customizing an ingestible capsule using interchangeable sensing components. [0013] These and other objects and advantages will become apparent from the foregoing and ongoing written specification, the drawings, and the claims. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a schematic of a first embodiment of the modular ingestible capsule system. [0015] FIG. 2 is a front plane view of a first embodiment of the modular ingestible capsule. [0016] FIG. 3 is a longitudinal vertical sectional view of the modular capsule shown in FIG. 2 , taken generally on line A-A of FIG. 2 . [0017] FIG. 4 is an exploded view of the modular capsule shown in FIG. 2 . [0018] FIG. 5 is a longitudinal vertical sectional view of the modular capsule shown in FIG. 4 , taken generally on line B-B of FIG. 4 . [0019] FIG. 6 is a top plan view of the pressure modular cap shown in FIG. 1 . [0020] FIG. 7 is a transverse vertical sectional view of the modular cap shown in FIG. 6 , taken generally on line C-C of FIG. 6 . [0021] FIG. 8 is a top plan view of the pH modular cap shown in FIG. 1 . [0022] FIG. 9 is a longitudinal vertical sectional view of the modular cap shown in FIG. 8 , taken generally on line D-D of FIG. 7 . [0023] FIG. 10 is a front plan view of the pH and pressure modular cap shown in FIG. 1 . [0024] FIG. 11 is a transverse horizontal sectional view of the modular cap shown in FIG. 10 , taken generally on line E-E of FIG. 10 . [0025] FIG. 12 is a transverse horizontal sectional view of the modular cap shown in FIG. 10 , taken generally on line F-F of FIG. 10 . [0026] FIG. 13 is an exploded view of a second embodiment of the modular ingestible capsule. [0027] FIG. 14 is a longitudinal vertical sectional view of the modular capsule shown in FIG. 13 , taken generally on line G-G of FIG. 13 . [0028] FIG. 15 is a diagram of electrical connections for the modular capsule shown in FIG. 5 . [0029] FIG. 16 is an exploded view of a third embodiment of the modular ingestible capsule. [0030] FIG. 17 is a longitudinal vertical sectional view of the modular capsule shown in FIG. 16 , taken generally on line H-H of FIG. 16 . [0031] FIG. 18 is a diagram of electrical connections for the modular capsule shown in FIG. 17 . DESCRIPTION OF PREFERRED EMBODIMENTS [0032] At the outset, it should be clearly understood that like reference numerals are intended to identify the same structural elements, portions or surfaces consistently throughout the several drawing figures, as such elements, portions or surfaces may be further described or explained by the entire written specification, of which this detailed description is an integral part. Unless otherwise indicated, the drawings are intended to be read (e.g., cross-hatching, arrangement of parts, proportion, degree, etc.) together with the specification, and are to be considered a portion of the entire written description of this invention. As used in the following description, the terms “horizontal”, “vertical”, “left”, “right”, “up” and “down”, as well as adjectival and adverbial derivatives thereof (e.g., “horizontally”, “rightwardly”, “upwardly” etc.), simply refer to the orientation of the illustrated structure as the particular drawing figure faces the reader. Similarly, the terms “inwardly” and “outwardly” generally refer to the orientation of a surface relative to its axis of elongation, or axis of rotation, as appropriate. [0033] Referring now to the drawings and, more particularly, to FIG. 1 thereof, this invention provides a modular ingestible capsule system for evaluating the gastrointestinal tract of a subject, of which a first embodiment is generally indicated at 14 . As shown in FIG. 1 , system 14 generally includes a standard capsule body 16 that is adapted to be connected with multiple different but interchangeable modular caps 18 , 19 and 20 . Body 16 houses certain standard electronics for the capsule and each of caps 18 , 19 and 20 are attachable to body 16 and include different sensors or combinations of sensors for sensing parameters of the gastrointestinal tract of a subject. Body 16 and caps 18 , 19 and 20 are designed such that the capsule user can choose the cap having the sensor or sensor combination desired at that time and can plug and attach the cap to the capsule body to provide the desired capsule just prior to having the patient ingest the capsule. Thus, system 14 allows the user to selectively customize the ingestible capsule using interchangeable sensing components. Multiple different modular components may be interchangeably used with standard base component 16 . While this embodiment describes modular components having pH and pressure sensors, caps having other types of sensors may be used, such as temperature sensors, blood sensors, and imaging sensors. [0034] FIG. 2 shows modular cap 18 connected to capsule body 16 . As shown, connected they form an elongated generally ellipsoid-shaped device 15 , somewhat resembling a medicament capsule. Capsule 15 is adapted to be ingested or otherwise positioned within a tract to sense pressure, pH and/or temperature within the tract and to transmit such readings. The capsule is generally provided with an outer surface or shell to facilitate easy swallowing of the capsule. In the preferred embodiment, capsule 15 is an autonomous swallowable capsule and is self-contained. Thus, capsule 15 does not require any wires or cables to, for example, receive power or transmit information. The pH, pressure and/or temperature data are transmitted from within the GI tract to a remote data receiver. [0035] As shown in FIGS. 2-5 , standard capsule body 16 generally includes a power supply 22 , a transmitter 23 , an antenna 24 , an activation switch 25 and a temperature sensor 27 housed in a hard shell or casing 21 . One end 21 a of casing 21 is rounded and the other end terminates in an annular rim 21 b and includes an electrical receptacle 26 adapted to receive a corresponding electrical plug. Power supply 22 and transmitter 23 are connected to each other and to electrical receptacle 26 . [0036] In this embodiment, power supply 22 is a lithium battery, although it is contemplated that other batteries may be used, such as a silver-oxide battery. Power supply 22 is adapted to power the electrical components of capsule 15 when in the gastrointestinal tract of a subject. [0037] To maximize its operation life, battery 22 is activated just prior to ingestion by way of a magnetic activation switch 25 adapted to turn the capsule on and off. In this embodiment, activation switch 25 is a circuit operating between battery 22 and the electrical components that selectively powers on and off the electronic components by way of a magnetic sensor which responds selectively to the presence, absence and/or polarity of a magnetic field. A number of conventional switches may be used. For example, an “active” reed switch system may be used, in which an external magnetic field actively holds a reed switch so that the circuit remains open. When the ingestible capsule is removed from the magnetic field, the reed switch closes the circuit, thereby activating the capsule. An alternative method is to use a passive reed switch and a magnetizable bias magnet asymmetric design manipulated by an external magnet. The circuitry of the capsule is selectively switched on and off depending on the magnetic state of the bias magnet, which determines the reed switch on/off state. The magnetic activation and deactivation circuit disclosed in U.S. patent application Ser. No. 11/899,316 entitled “Magnetic Activation and Deactivation Circuit and System,” the entire disclosure of which is incorporated herein by reference, may also be used in this embodiment. [0038] In this embodiment, transmitter 23 is a radio frequency (RF) transmitter that transmits measurements from capsule 15 when it is in the gastrointestinal tract of a subject to a remote receiver. Transmitter 23 transmits measurements at about 434 MHz. A portable data receiver worn by the subject receives and stores the measurements transmitted by transmitter 23 for later download through a docking station to a Windows PC compatible computer, such as a conventional laptop or a desktop. Antenna 24 amplifies the transmit power of transmitter 23 so that it can be received by the remote receiver. [0039] In this embodiment, body 16 also includes a temperature sensor 27 communicating with power supply 22 and electrical receptacle 26 . This temperature sensor may be used to compensate or provide a baseline relative to sensors in the modular cap that is connected to base 16 . [0040] Caps 18 , 19 and 20 may be interchangeably used with body 20 to form an ingestible capsule. Cap 18 is adapted to be used with body 16 if the user desires to sense pressure within the gastrointestinal tract of the subject with capsule 15 . As shown in FIG. 7 , cap 18 has an outer shell 28 that houses a processor 31 and pressure sensor assembly 29 . As shown, shell 28 has a top rounded end and terminates at an annular rim 28 c. [0041] Pressure sensor assembly 29 includes a chamber 38 between an inner wall 28 b and a flexible membrane 28 a of shell 28 . Chamber 38 is filled with a fluid. A rigid PCB arm 36 extends into the chamber and supports a conventional piezoelectric bridge 39 . As fluid presses against bridge 39 , it creates an electrical signal which corresponds to the pressure of fluid in chamber 38 . The fluid is a non-compressible medium that transfers a force onto the sensing mechanism for sensor 39 . In this embodiment, the fluid used is a dielectric gel. Alternatively, it is contemplated that other fluids, such as mineral oil, may be used or an inert gas may be used instead of a fluid. Thus, pressure sensor 39 is operatively arranged to sense pressure within chamber 38 . An analog to digital converter 41 is provided to convert the analog signal from sensor 39 to a digital signal. [0042] As shown in FIGS. 6-7 , multiple chambers 38 a , 38 c with multiple pressure sensors 39 a , 39 c may be included on capsule 18 . In this embodiment, cap 18 is somewhat elliptical, and includes four chambers and four pressure sensors 39 located generally at the opposed corners on the major axis 37 b and 37 d and minor axis 37 a and 37 c of cap 18 . [0043] Pressure sensor assembly 29 is connected to and communicates with micro-processor 31 . Processor 31 controls the sampling rate of sensor 29 and is also connected through plug 32 and port 26 to transmitter 23 to control the RF transmission frequency and the information and data being transmitted. Processor 31 may also process signals received from sensor 29 and temperature sensor 27 and may provide other command or control signals to capsule components. The term processor as used herein refers to any data processor. Some examples of processors are microprocessors, microcontrollers, CPUs, PICs, PLCs, PCs or microcomputers. The processor described above is for purposes of example only. Thus, the term processor is to be interpreted expansively. [0044] Cap 20 is adapted to be used with body 16 if the user desires to sense pH within the gastrointestinal tract of the subject with capsule 15 . As shown in FIG. 9 , cap 20 has an outer shell 33 that houses a processor 34 , an analog to digital converter 41 , and a pH sensor assembly 30 . In this embodiment, pH sensor assembly 30 comprises a conventional ISFET type pH sensor 40 on one side with a pH reference electrode 42 on the other. ISFET stands for ion-selective field effect transistor and the sensor is derived from MOSFET technology (metal oxide screen field effect transistor). A current between a source and a drain is controlled by a gate voltage. The gate is composed of a special chemical layer which is sensitive to free hydrogen ions (pH). Versions of this layer have been developed using aluminum oxide, silicon nitride and titanium oxide. Free hydrogen ions influence the voltage between the gate and the source. The effect on the drain current is based solely on electrostatic effects, so the hydrogen ions do not need to migrate through the pH sensitive layer. This allows equilibrium, and thus pH measurement, to be achieved in a matter of seconds. The sensor is an entirely solid state sensor, unlike glass bulb sensors which require a bulb filled with buffer solution. Only the gate surface is exposed to the sample. An analog to digital converter 41 is provided to convert the analog signal from sensor 40 to a digital signal. The pH ISFET sensor 40 and pH reference electrode 42 extend from the shell 33 in protective channels, such that the sensors are exposed to the medium of the gastrointestinal tract but are protected from breaking or causing damage. [0045] Micro-processor 34 is connected to and communicates with pH sensor 30 . Processor 34 controls the sampling rate of sensor 30 and is also connected through plug 35 and port 26 to transmitter 23 to control the RF transmission frequency and the information and data being transmitted. Processor 34 may also process signals received from sensor 30 and temperature sensor 27 and may provide other command or control signals to capsule components. [0046] Cap 19 is adapted to be used with body 16 if the user desires to sense both pH and pressure within the gastrointestinal tract of the subject with capsule 15 . As shown in FIGS. 10-12 , cap 19 has an outer shell 49 that houses a processor 44 , an analog to digital converter 44 , a pH sensor 48 , a pH reference electrode 43 , and a pressure sensor assembly 46 . As shown, pH sensor 48 and reference electrode 43 are similar to the pH sensor assembly 30 of cap 20 . Pressure sensor assembly 46 is similar to pressure sensor assembly 29 of cap 19 , with a flexible membrane portion 49 a of shell 49 and inner wall 49 b of shell 49 defining a chamber 47 containing a piezoelectric bridge 45 operatively arranged to sense pressure within chamber 47 . Again, since the output from the sensors is an analog signal, an analog to digital converter 41 is provided to convert the signal from sensor 45 and 48 to a digital signal. Micro-processor 44 is connected to and communicates with pH sensor 48 and pressure sensor 46 . Processor 44 controls the sampling rate of sensors 48 and 46 and is also connected through a plug (not shown) and port 26 to transmitter 23 to control the RF transmission frequency and the information and data being transmitted from body 16 . Processor 44 may also process signals received from sensors 48 and 46 and temperature sensor 27 and may provide other command or control signals to capsule components. [0047] After activation and ingestion, capsule 15 senses and transmits measurements for at least 120 hours after activation. In the preferred embodiment, the range and accuracy of the sensors are generally 1 to 9.0 pH units with an accuracy of ±0.5 pH units, 0 to 350 mmHg with an accuracy of ±5 mmHg, and 25° to 49° C. with an accuracy of ±1° C. [0048] Caps 18 , 19 , 20 and capsule body 16 have both mechanical connecting elements and electrical connecting elements. As shown in FIGS. 5 and 7 , the shell of the subject modular cap attaches to the shell 21 of body 16 in this embodiment by a snap connection. The bottom peripheral rim 28 c of the subject cap includes an annular cavity 61 . A corresponding annular protrusion 62 is provided in the top rim 21 b of shell 21 of body 20 . Annular cavity 61 in the subject cap is configured to receive protrusion 62 of the body. The body and subject cap are thereby pressed together until angular protrusion 62 snaps into corresponding cavity 61 , thereby holding the subject cap and body 16 together. However, it is contemplated that other types of connections may be used to attach the subject cap to body 16 . For example, shell 28 and shell 21 may include corresponding screw threads with matching grooves along a flange on their outer rims so that the two ends of the shells may be screwed together. Alternatively, the rims of shells 28 and 21 may be attached by gluing or bonding the two parts together or the shells may be threaded and twisted relative to one another to provide a connection. [0049] The electrical connection between the subject cap and body 16 is provided by an I/O connector having an electrical connecting input or plug 32 , 35 on the subject cap and an electrical output connection, port or receptacle 26 in body 16 . Port 26 is adapted to receive either plug 32 or plug 35 and to electrically connect the subject components of the selected cap and capsule body 16 . To form the capsule, the user selects the desired cap, aligns the plug in the subject cap with receptacle 26 of body 16 , and then presses the cap and body together until they snap in place, by which an electrical and mechanical connection is formed between them. Thus, the subject cap and body 16 may be easily or readily connected together by the user. The body and subject cap may be connected by hand, and may also be releasably connected such that the subject cap and body may be easily or readily detached from each other. [0050] As shown in FIG. 15 , power supply 22 is connected to transmitter 23 and temperature sensor 27 in capsule body 16 and is connected through port 26 and plug 32 / 35 to the subject sensors 29 / 30 , subject processor 31 / 34 and converter 41 . Power supply 22 is, as described above, activated by switch 25 . The subject sensors 29 / 30 are connected through analog to digital converter 41 to the subject processor 31 / 34 . Processor 31 / 34 is also connected through plug 32 / 35 and port 26 to transmitter 23 . Transmitter 23 is in turn connected to antenna 24 . [0051] FIGS. 13 and 14 show an alternate capsule body 50 which is adapted to allow for modular caps to be interchangeably attached to both ends of the body. As shown, a pressure sensing cap 18 is attached to one end of body 50 and a pH sensing cap 20 is attached to the other end of body 50 . Capsule body 50 includes the same internal components as with body 16 housed in a cylindrical shell 52 . However, rather then having a single electrical receptacle 51 , body 50 includes a second electrical receptacle 58 at the opposed end. Thus, electrical plug 32 of cap 18 may be inserted into receptacle 51 of capsule body 50 , and plug 35 of cap 21 may be inserted into receptacle 58 of capsule body 50 to provide an ingestible capsule that senses both pH and pressure. With this embodiment, different sensing configurations may be formed by the user as desired. For example, caps having different sensors may be attached to the ends of capsule body 50 or, alternatively, caps having the same sensors may be attached to the ends of capsule body 50 . As with the first embodiment, caps 18 and 20 and body 50 are connected both electrically and mechanically. Thus, shell 28 of cap 18 attaches to end 50 a of shell 52 and shell 33 of cap 20 attaches to the other end 50 b of shell 52 . As discussed above, in this embodiment the shells are also attached or connected using a snap connection. However, other connecting methods or features may be used to provide the attachment such that the capsule does not leak when it is ingested and passes through the gastrointestinal tract of the subject. [0052] Once the desired capsule is put together by the user, it is ingested by the subject. As the capsule passes through the gastrointestinal tract of the subject, the pH sensor and/or pressure sensor take measurements and body 16 transmits the measurements to a receiver being worn by the user, where they are stored. [0053] FIGS. 16-18 show a third embodiment 70 of the modular capsule. Capsule 70 is similar to the first embodiment in that capsule body 72 includes a power supply 22 , a transmitter 23 , an antenna 24 , an activation switch 25 and a temperature sensor 27 housed in a hard shell or casing 21 . However, in this embodiment capsule body 72 also houses microprocessor 74 . [0054] Cap 71 is similar to caps 18 - 20 in that it is attachable to body 72 and comes in different versions having different sensors or combinations of sensors for sensing parameters of the gastrointestinal tract of a subject. However, cap 71 differs in that it does not contain a microprocessor and instead contains a settable ID tag programmed into non-volatile memory 73 . The settable ID tag is used to indicate the type of sensor or cap being attached to capsule body 72 . For example, if cap 71 is a version that contains a pressure sensor 29 it has a first ID tag. If it is a version that contains a pH sensor it has a second and different ID tag. In this embodiment, the ID tag is programmed into an EEPROM or flash memory or set using a DIP switch during manufacturing, and the EEPROM or DIP switch is a I2C-bus compatible device which allows it to communicate directly through the I2C-bus to microprocessor 74 in capsule body 72 . Thus, in this embodiment there is no need for additional interfacing. A four position Dip Switch or 4-bit EEPROM allows for 16 different versions of modular sensing cap 71 to be identified and a five position Dip Switch or 5-bit EEPROM allows for 32 different versions of modular sensing cap 71 to be identified and used with a single body 72 . Once activated, the ID tag acts as a control line into processor 74 . The ID tag is read and variables within the operating program are set according to a look-up table. These variables may include parameters which are unique to the particular sensor on the subject cap 71 , such as the sampling rate of the sensor, the transmission burst duration and the rate of transmission bursts. [0055] Different versions of cap 71 , each version having a different sensor(s) may be attached to body 72 as in the first embodiment. As shown in FIG. 18 , cap 70 includes an I-O connector having an electrical connecting input or plug 76 on the subject cap 71 and an electrical output connection, port or receptacle 75 in body 72 . Power supply 22 is connected to a transmitter 23 , temperature sensor 27 and processor 74 in capsule body 72 , and is connected through port 75 and plug 76 to the subject sensor(s), memory 73 and converter 41 in cap 71 . As with the first embodiment, power supply 22 is activated by switch 25 . The subject sensors are connected through analog to digital converter 41 and, through plug 76 and port 75 , to processor 74 . Temperature sensor 27 in body 72 is connected directly to processor 74 . Processor 74 is connected directly to transmitter 23 and transmitter 23 is in turn connected to antenna 24 . [0056] While the above embodiments have been described in relation to the gastrointestinal tract of a human, it is contemplated that the system may be used in connection with the gastrointestinal tract of other animals. [0057] The present invention contemplates that many changes and modifications may be made. Therefore, while the presently-preferred form of the improved modular capsule system has been shown and described, and a number of alternatives discussed, persons skilled in this art will readily appreciate that various additional changes and modifications may be made without departing from the spirit of the invention, as defined and differentiated by the following claims.

1a

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application takes priority from U.S. Provisional Patent Application Ser. No. 60/629,141, filed on Nov. 18, 2004. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to implants and more particularly to an implant device for repairing a fractured bone structure and providing a compensation for a loss of volume. [0004] 2. Background [0005] Bone fractures in humans and animals may present fracture-related complications. Among such complications is the situation in which bone fragments resulting from a fracture move apart or are crushed, leaving a fracture unable to heal properly without utilizing permanent implants. Often an implant becomes necessary because otherwise the affected bone areas may not align or join properly. Fractures of human facial bones frequently present such characteristics and can be particularly acute at the eye orbit. The eye's internal bone structure is relatively thin and complex in shape and thus in many situations requires surgical procedures to (a) stabilize the fractured internal orbit bone and (b) insert an implant to compensate for a loss of volume, particularly between the orbit floor and the eyeball. Other bone areas, such as portions of the skull including cheeks and forehead may also require similar surgical procedures. [0006] In one type of a surgical procedure of the eye orbit, a metallic biocompatible and pliable plate that is trimmed to an appropriate size and shape is placed at the orbit floor and then secured to the front skull bone by screws. Such a procedure is utilized when a portion of the eye orbit is fractured. In this manner, the plate itself rests on the orbit floor and provides a relatively firm or stiff base. If compensation for a loss of volume is necessary, a porous synthetic implant of appropriate thickness and shape is implanted to compensate for such a volume loss. Although the porous implants provide adequate volume, they can migrate out of the implanted locations, thereby losing their effectiveness. Such implants exhibit an increased likelihood to migrate if there is insufficient stable bone around the porous implant or if the bone is unstable. In such cases, the implant may migrate anteriorly or down into the sinus, creating a need for further surgery to correct for the implant migration. In addition, a shift or migration of the porous material from its implanted location can cause the eyeball to sag or shift, which may also require a subsequent surgical procedure and/or a new implant to repair such a condition. [0007] It is thus desirable to have a biocompatible implant that will (i) provide a necessary support to the fractured or deformed bone structure, (ii) provide a volume to compensate for any diminished volume, such as due to tissue loss, and (iii) not have a tendency to shift after it has been implanted. [0008] The present invention addresses some of the above-noted problems with currently available implants and provides a implant that provides a structural support for a fractured bone structure and compensation for the loss of volume and methods of making and using such an implant. SUMMARY OF THE INVENTION [0009] The present invention provides an implant that includes a base plate or a base member that provides structural support to a fractured bone area and a volume member affixed to the base plate to provide compensation for a loss of volume. The base plate may be made from any biocompatible material that will provide the desired structural support including a metallic material such as titanium. The shape, size and thickness of the base plate is chosen to provide for the desired internal fixation of fractures, as a material for stabilization of the bone and as a bone graft support material. The plate may include perforations and may be coated with biocompatible material to inhibit in-growth of tissue into the perforation. The volume member may be a porous member made from any suitable material, including a substantially non-metallic material, such as polyurethane. [0010] The base member may be relatively thin compared to the volume member. The volume member may be affixed to the base member by any suitable manner, including affixing or bonding these members with a suitable adhesive bonding agent or by fusing them together. The implant is placed on the fractured bone area and the base member is secured to an adjacent bone structure in a suitable manner such as with one or more bone screws or any other appropriate attaching device. The base member of the implant will tend to remain in its implanted place where it has been secured and the volume member remains in its implanted location because it is affixed to the base member. [0011] Examples of the more important features of the invention have been summarized (albeit rather broadly) in order that the detailed description thereof that follows may be better understood and in order that the contributions they represent to the art may be appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject of the claims appended hereto. BRIEF DESCRIPTION OF THE DRAWINGS [0012] For detailed understanding of the present invention, reference should be made to the following detailed description of the preferred embodiment, taken in conjunction with the accompanying drawing wherein like elements have been given like numerals and wherein: [0013] FIG. 1 is a perspective view of an exemplary human skull showing a fracture of the right eye orbit floor and a fracture in the skull that may require an implant to provide structural support for the fracture areas and compensation for a loss of volume; [0014] FIG. 2 is a cross-sectional view of an exemplary implant according to one embodiment of the present invention; [0015] FIG. 3 is a top view of the implant of FIG. 2 ; [0016] FIG. 4 shows a top view of an alternative embodiment of an implant according to the present invention; [0017] FIG. 5 is a top view of an exemplary embodiment of the base plate of the implant of FIG. 2 ; and [0018] FIG. 6 is a perspective view of the human skull shown in FIG. 2 with an implant made according an embodiment of the present invention placed on the orbit floor and attached to the facial bone. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0019] FIG. 1 is a perspective view of a human skull 10 showing the right eye orbit 20 with the orbit floor 30 , medial wall 32 , lateral wall 34 , posterior wall 36 , a facial bone structure 38 and the forehead 39 . A variety of bone fractures of the eye orbit 20 can occur due to accidents or congenital defects. Such fractures may occur on one or more areas of the orbit floor 30 . Bone area 40 on the orbit floor is intended to show only an example of a bone fracture of the orbit floor 30 , and represents any fracture type that may require a surgical implant to provide both the structural support to the orbit floor 30 and a certain amount of volume over such a structural support to compensate for a loss of volume for the eye or globe. In reality, many different types of fractures occur in the eye or other areas of the body. Element 41 shows fractures or bone defects in the forehead that may require implants to provide both the bone support and volume compensation. Thus, the apparatus of this invention is intended for use on all such fractures whether on the skull or any other bone area. Also, any volume compensation provided by the implant is desired to remain in the implanted location. [0020] FIG. 2 shows a cross-sectional view of an exemplary implant 50 according to one embodiment of the present invention. The implant 50 includes a base member (plate, strip or panel) 52 . The plate 52 may include any number of perforations 54 . The plate 52 is usually relatively thin (typically about one mm) and is made from a biocompatible material (i.e., an allopathic material) suitable for use in humans or animals. The plate 52 may be made from titanium or any other suitable biocompatible material. Titanium is an example of widely accepted biocompatible material for such applications. A plate 52 made from titanium, for example, or any other suitable relatively stiff material, can support itself when placed on a fractured area, such as a fractured orbital floor. Platinum is another suitable material and is useful because it has low density and low elastic modulus (stiffness) compared to materials such as stainless steel or cobalt chromium. Titanium plates also are pliable and corrosion resistant. However, for the purpose of this invention any material that will provide the desired or adequate support for the fractured bone portion may be used. Materials such as Teflon, supramid, tantalum, vitallium, polyethylene etc., if suitable, may also be used. Hybrid materials, including metallic and nonmetallic materials, may also be used. A pliable material is desirable because it can be trimmed to a desired shape and size with an instrument such as scissors prior to implanting the implant into the body. The implant also may be made in various anticipated sizes and shapes. The plate 52 may incorporate one or more provisions for securing it to a bone structure such as one or more extensions or fingers 56 , having a suitable through-opening or hole 58 for inserting a securing member, such as a bone screw, therethrough. The extension 56 may also be secured to the bone in any other suitable manner. [0021] The plate 52 , when placed on the orbit floor 30 and affixed to a bone structure, such as with surgical screws, rests on the orbit floor 30 to provide structural support to the orbit floor. The implant 50 also includes a second member 64 (also referred herein as a volume member) that is attached to a side 65 (usually a top side) of the plate 52 . The volume member 64 is attached to the plate 52 in a manner so that the volume member 64 will tend to remain (or will remain substantially) in place (i.e., not shift) relative to the base plate 52 after the implant has been implanted. The combination member also is referred herein as a hybrid implant or device. [0022] The volume member 64 may be attached to the plate 52 by any suitable manner including, but not limited to, by an adhesive 60 or any bonding agent or material or by fusing the volume member on to the plate 52 . In another aspect the volume member 64 and the plate 52 may be bonded or attached to each other by a heating mechanism or by an electrochemical reaction. The bonding material may also be of a type that will dissolve over a time period after implantation of the device in the body. As the bonding material dissolves, this allows the body's natural healing properties or mechanisms to ingrow or vaginate and keep the volume member substantially at its implanted position. Examples of such bonding agents include products sold under the trade names “cyanocrylate” glue or “dermabond”. [0023] The volume member 64 may be a porous material having any desired shape and size. In the embodiment shown in FIG. 2 , the volume member 64 has a substantially flat bottom surface 63 and a contoured top surface 68 that has sections 64 and 66 of different thicknesses. The volume member's contour and the shape depend upon the amount and dimensions of the volume to be compensated. Typically, the volume member 64 is thicker than the plate 52 . The volume member may be a porous member made from a non-metallic biocompatible material such as a polyurethane material. “Medpor,” for example, is such a polyurethane material that is commonly used for compensation of volume in surgical implants. The volume material is usually not compressible by the pressure exerted thereon after the implant. The implant 50 , thus, is a hybrid implant that includes a relatively stiff member, usually a metallic member, that provides structural support to the fractured bone and a volume member 64 that provides for the compensation for loss of volume. [0024] FIG. 3 shows a top or plan view of a hybrid implant that has a base plate 52 ′ that includes attachment extensions 56 having bone screw holes 58 . The volume member 64 ′ is suitably attached on a surface or side of the plate 52 , by man. [0025] FIG. 6 shows another embodiment 55 a of a hybrid implant of the present invention. The implant 55 a includes a base plate 52 a suitable for a small longitudinal fracture having holes 54 a for securing it to the bone and a volume member 64 a suitably secured to the base plate. The plate 52 a has no extensions and may or may not have any perforations therein. [0026] FIG. 5 shows an exemplary embodiment of a base plate 70 that may be used in the present invention. The base plate 70 includes a main section or body that has cuts or openings 74 on each side, opening 76 on the rear side of the plate 70 and opening 78 on the front side. These openings provide flexibility to the plate 70 and allow relatively easy shaping of the plate to match the orbit base or any other fractured bone area. The plate 70 also includes one or more extensions or fingers 80 here shown as an example (on the front side of the plate 70 ), each such finger having an opening 82 to accommodate a bone screw therethrough. It should be noted that bone screw is one convenient manner to secure the plate to the bone. Any other attachment device or method may be used to secure the plate 52 ( FIG. 6 ) to the bone structure for the purpose of this invention. The plate 52 also may include perforations 72 that permit communication between the bone structure and surrounding tissue mass. As noted above, the plate 70 may be made from pure titanium, which has been determined to be suitable as an implant material or any other suitable biocompatible material. The plate 70 also may be coated with a suitable biocompatible to inhibit the in-growth of tissue in the perforations. [0027] FIG. 4 shows the implant 50 of FIG. 2 placed or implanted in the right orbit of a human skull. A hybrid implant that matches the need for a particular surgery is selected. The selected implant is then shaped, if necessary, and placed on the orbit floor 30 ( FIG. 1 ) or other fractured bone as the case may be. The extensions 50 are then secured to the facial bone 38 ( FIG. 1 ) by bone screws 90 ( FIG. 6 ). Once the plate 52 is secured or affixed to the facial bone 38 , the base plate 52 remains in its implanted position. Further, since the volume member 64 ( FIG. 2 ) is affixed on to the plate 52 , it will also remain in its initial location without shifting relative to the plate 52 . The base plate 52 , thus, provides the desired structural support to the fractured bone area and remains in its implanted location because it is secured to the bone structure, and the volume member 64 provides for the loss of volume and remains in its implanted location because it is affixed to the base plate 52 . [0028] In general, the hybrid implant may be made in any number of shapes and sizes during manufacturing. Both the volume member and the base plate element may be modified after manufacture to conform to shape and size for individual situations. The volume member of a desired size and shape is affixed to a compliant base plate. The base plate may include one or more provisions for affixing it to a bone structure. [0029] The foregoing description is generally directed to embodiments relating to implants for eye orbit. For the purpose of illustration and explanation the implant of the present invention, however, may be used for any surgical procedure in humans or animals. The base plate may also be of any thickness compared to the volume member. It will also be apparent, however, to one skilled in the art that many modifications and changes to the embodiment set for the above are possible without departing from the scope and the spirit of the invention. It is intended that the following claims be interpreted to embrace all such modifications and changes.

1a

BACKGROUND OF THE INVENTION U.S. Pat. No. 5,390,930 to the same inventors of this application discloses a golf practice device including: a base, a golf ball secured on a linking arm having a sleeve pivotally mounted on a shaft erected on the base, two rotor magnets having opposite outer magnetic poles and diametrically secured on two opposite ends of the sleeve, and two stator magnets having opposite inner magnetic poles and respectively secured on two opposite ends of the shaft, with the two stator magnets diametrically aligned with the two rotor magnets fixed on the sleeve rotatably mounted on the shaft, each rotor magnet having an outer magnetic pole facing an inner magnetic pole of each stator magnet with the outer magnetic pole of the rotor magnet having a polarity opposite to a polarity of the inner magnetic pole of the stator magnet for a mutual attraction between each rotor magnet and each stator magnet, whereby upon striking of the ball by a club for rotating the ball, the ball will be stopped at its starting position as automatically restored by the magnetic force acting between each stator magnet and each rotor magnet. Even though the golf ball will be automatically restored as disclosed in the U.S. Pat. No. 5,390,930, there is not provided with any optical and sound display upon striking on the ball, thereby still lacking of exciting interest for the player. SUMMARY OF THE INVENTION The object of the present invention is to provide a golf practice device including: a supporting base, a golf ball secured on a linking arm having a sleeve pivotally mounted on a shaft erected on the base, two rotor magnets having opposite outer magnetic poles and diametrically secured on two opposite ends of the sleeve, two stator magnets having opposite inner magnetic poles and secured on two opposite ends of a housing for surrounding the two rotor magnets for a mutual attraction between each stator magnet and each rotor magnet, a power generator having an iron core wound with coil windings on the core and surrounding the two rotor magnets for generating power due to change of magnetic field when rotating the sleeve and the two rotor magnets with respect to the iron core as driven by a hitting on the golf ball, and a display device for converting the power to an optical and audio signal for a visual and audio display for indicating the striking strength as hit by the golf player, and upon magnetic attraction between each stator magnet and each rotor magnet, the golf ball after the rotation will be stopped at its starting position as automatically restored by the magnetic attraction. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a sectional drawing of the present invention when erected. FIG. 2 is a sectional drawing of the present invention when viewed from 2--2 direction of FIG. 1. FIG. 3 is an illustration showing the power generating means of the present invention. FIG. 4 is a perspective view of the present invention. FIG. 5 is a block diagram of the display means of the present invention. FIG. 6 shows a diagram of voltage curves versus power generating time period upon hitting on golf ball of the present invention. FIG. 7 shows an electronic circuit of a visual display in accordance with the present invention. FIG. 8 is an illustration of the present invention provided with LED display. FIG. 9 shows an electronic circuit of the present invention with LED display. FIG. 10 is an illustration showing a magnetic restoring of the golf ball at its starting position in accordance with the present invention. FIG. 11 shows another preferred embodiment of the supporting base of the present invention. DETAILED DESCRIPTION As shown in FIGS. 1-10, the present invention comprises: a supporting base 1 laid on a supporting surface such as a mat 10 or grass yard 10a (FIG. 11), a ball means 2, a rotor magnet means 3, a stator magnet means 4, a power generating means 5, a display means 6, and a housing 7. The supporting base 1 includes: a shaft 11 having a lower male-threaded portion 12 engageable with a female-threaded hole 14 formed in a coupling member 152 which is embedded in a socket 151 recessed in a base block 15, a washer 154 packed between the shaft 11 and the coupling member 152, an upper male-threaded portion 13 formed on an upper portion of the shaft 11 for securing the housing 7 and the power generating means 5 thereon, and a central opening 111 longitudinally formed through the shaft 11 for passing electric wires 54 of the power generating means 5 in the opening 111. The coupling member 152 embedded in the base block 15 includes: an annular groove 153 annularly recessed in the coupling member 152, a locking bolt 17 having a bolt end 171 insertable in the base block 15 and engageable with the annular groove 153 in the coupling member 152 for locking the coupling member 152 when suitably positioned, and a handle 18 jacketed on the bolt 17 for driving the bolt 17. The base block 15 may be modified to be the embodiment as shown in FIG. 11, which includes: a fixing bolt 16 which may be a screw or a spiral coil protruding downwardly to be stably dug into a grass yard 10a, two shoulder connectors 181 protruding rightwardly and leftwardly from the block 15 for detachably mounting two handles 18a on the two connectors 181 for rotating the fixing bolt 16 for stabilizing the base 1 on the yard 10a, and a locking bolt 17 inserted through the base block 15 having a bolt end 171 engaged with the groove 153 recessed in the coupling member 152 for locking the coupling member 152 and the base 1 in position. The base 1 may be secured on an area 101 of a mat 10 having a target line 100 marked on the mat for aiming a target of the golf ball 23, and a starting point 100a marked on the target line for a teeing position where the rotor magnet means 3 is magnetically attractable to the stator magnet means 4. The ball means 2 includes: a sleeve 21 rotatably engageable with the shaft 11 of the base 1, a linking arm 22 having an inner arm end pivotally connected to a lower portion of the sleeve 21 by a bolt 22a and an outer arm end secured with the golf ball 23, with an upper portion of the sleeve 21 secured with the rotor magnet means 3. The linking arm 22 will be pivoted about the bolt 22a for adjusting the height of the ball 23 above the mat or yard. The rotor magnet means 3 includes: a first rotor magnet 31 and a second rotor magnet 32 diametrically secured on two opposite end portions of the sleeve 21, with the first rotor magnet 31 having an outer magnetic pole (such as N pole) opposite in polarity to an outer magnetic pole (such as S pole) of the second rotor magnet 32. The stator magnet means 4 is disposed around said rotor magnet means 3, and includes: a first stator magnet 41 and a second stator magnet 42 respectively fixed on two opposite end portions of the housing 7 preferably at the lower housing portion 71, with the first stator magnet 41 having an inner magnetic pole (such as S pole) facing to and opposite in polarity to an outer magnetic pole (such as N pole) of the first rotor magnet 31 and having an inner magnetic pole (such as S pole) of the first stator magnet 41 opposite in polarity to an inner magnetic pole (such as N pole) of the second stator magnet 42. The housing 7 includes a lower housing portion 71 below a central partition plate 72, an upper housing portion 74 above the partition plate 72, and a cap 75 closing the upper housing portion 74. The power generating means 5 includes: a power generating iron core 51 having two core arm members 511 generally inversed U shaped and diametrically mounted on an upper portion of the shaft 11 of the base 1 as packed on the central partition plate 72 and a washer 112 to be angularly deviated from the two stator magnets 41, 42 for 90 degrees about a longitudinal axis 110 of the shaft 11 (FIGS. 1, 2 and 10), with the two core arm members 511 protruding downwardly through the central partition plate 72 of the housing 7 to surround the two rotor magnets 31, 32 when rotated as shown in FIG. 3, a power generating coil 52 wound on the core 51 and having a pair of electric wires 54 led from two opposite ends of the coil 52 and passing through the central opening 111 in the shaft 11 to connect an electric socket 541 formed in the coupling member 152 for connecting the display means 6 through a connector 60, with the core 51 retained on a top threaded portion 13 of the shaft 11 by means of an insulative washer 53, a thin washer 55 and a nut 56, whereby upon hitting on the golf ball 23 by a club (not shown), the linking arm 22 and the rotor magnets 31, 32 secured to the sleeve 21 on the inner end of the linking arm 22 will be rotated to induce electric current in the coil 52 wound on the core 51 for producing power through the electric wires 54 passing through wire holes 155 in the coupling member 152 for outputting current and voltage signals through the connector 60 of the display means 6 to a visual (optical) and an audio display as shown in FIGS. 5-9. A shaft hole 73 is formed in the partition plate 72 for rotatably engaging the shaft 11. The display means 6 and the power generating means 5 as shown in the drawing figures are only examples in accordance with the present invention, which are not limited and may be modified. As shown in FIG. 10, when the golf ball 23 is stricken (direction St) by a club from the starting point 100a, the ball 23 and the arm 22 will be rotated (R) about the shaft 11. After rotating of several turns, the ball 23 and its link 22 may be finally stopped as deviated from the starting point 100a as shown in dotted line of FIG. 10, the magnetically attractive force Fa between the opposite poles of the stator magnet and the rotor magnet as well as the magnetically repulsive force Fr between the same poles of stator magnet and the rotor magnet will automatically restore (R1) the sleeve 21, the arm 22 and the ball 23 to its original starting point 100a ready for a next convenient striking on the ball. The display means 6 as shown in FIG. 5 includes: a receiver 61 for receiving input current and voltage signal produced from the power generating means 5 through a connector 60 and rectifying the input current, a control circuit 62 triggered by the current and voltage signal as received from the receiver 61 and processing the signals for outputting visual signal to a visual display 63 and an audio signal to an audio display 65 through a sound producing circuit 64. The voltage of the input signal produced from the power generating means 5 is proportional to the striking strength acting on the golf ball 23 and the input signal will trigger the control circuit 62 which may be an integrated circuit or a circuit comprised of a plurality of silicon-controlled rectifiers (SCR) as shown in FIG. 7. A stronger striking on the ball 23 will produce a larger voltage value such as V6 and will have a longer duration for generating the power such as t6 as shown in FIG. 6. The control circuit 62, once being triggered by the input signal, will process the input signal to output a visual signal and an audio signal of different ratings such as subsequent illumination of a plurality of light-emitting diodes L1˜L6 as shown in FIG. 7 each diode corresponding to each predetermined illuminating time interval different from the other. The stronger the ball is hit, the longer power generation will be obtained by the power generating means 5 and the corresponding LED may then be lit on at a delayed or longer time commensurating with the longer duration of power generation. The display means 6 as shown in FIG. 7 includes: a connector 60 connected to the socket 541 of the power generating means 5 for transmitting input current and voltage signal from the power generating means 5, a receiver 61 for receiving and rectifying the input signal from the power generating means 5, a control circuit 62 including a plurality of silicon-controlled rectifiers SCR1˜SCR5 connected in series between the receiver 61 and a visual display 63 which includes a plurality of light-emitting diodes L1˜L6 connected in series, each silicon-controlled rectifier (SCR) having an anode A connected to a positive pole of the input current, a gate G connected to a time-delay circuit comprised of a capacitor C1 and a resistor R1 connected in series between the positive and negative poles of the input current having a pre-set time delay for triggering the gate G at a delayed time to conduct the SCR, and a cathode C connected to a light emitting diode (LED) through a resistor R2 for limiting a safe voltage value for illuminating the LED and connected to a gate G of a next SCR, thereby subsequently delaying the conduction of the plurality of silicon-controlled rectifiers for subsequently lighting the plurality of light emitting diodes with respect to the time duration of power generation in response to the striking strength acting on the golf ball. Therefore, when a first striking on the ball to produce a first voltage value V1 (as shown in FIG. 6) having a power-generation time duration of t1, the first set of light emitting diodes (LED) L1 (FIG. 7) will be initially illuminated until the lapse of t1 and the SCR1 will be charged by its pre-set time delay constant of R1 and C1 and then conducted until the lapse of first time period t1, and a second striking (V2) will continue the power generation to allow SCR1 to power and light on the second set of LED L2 until the lapse of second time period t2. During the illumination of second set of LED L2, the SCR2 is being charged for its conduction and once being conducted until the lapse of t2, the SCR2 will power and turn on the third set of LED L3 if a third striking is acted on the ball to have a third voltage value V3 which is larger than V2. The L3 will be continuously turned on until the lapse of t3 or until the power produced by third striking is exhausted. By the way, the plural LEDs will be subsequently lit on showing the different ratings of striking strength from a weak degree to a strong degree when hitting the golf ball, thereby enhancing a player's interest. Different colors may be provided on the plural light-emitting diodes for a remarkable visual indication. The visual display 6a may be mounted on the housing 7 and connected to the wires 54 by connector 60a and switch 60b as shown in FIGS. 9, 8. A remote display system may be connected to the socket 541 by a connector 60 as shown in FIG. 9 The audio display 65 as shown in FIG. 5 includes: an amplifier and a speaker for amplifying the sound signal produced by the sound producing circuit 64 connected to the control circuit 62 for loudspeaking an output audio signal such as by sound, voice or music. For instance, a stronger hitting on ball may be converted to a stronger current and voltage signal for selecting an output sound, such as: a stronger whistling, a praising voice (for example: "very good"), or a playing of march music. The control circuit 62 may select the output sound signals with different ratings as pre-programmed in the control circuit 62 in response to the input current and voltage signal as produced and transmitted from the power generating means 5. An auxiliary power supply 66 may be provided for powering the circuits in control circuit 62, sound producing circuit 64, and the audio display 65. Other audio or visual display methods, circuits or systems may be modified in accordance with the present invention, without departing from the spirit and scope of this invention.

1a

BACKGROUND OF THE INVENTION [0001] The invention relates to a treatment for packaged food product, particularly meat, fish and poultry products, and more particularly to a treatment for beef, tuna fish and other red meat, fish and poultry products. [0002] The use of various gases for treating food is old and well known. Packaging of food in a modified atmosphere comprised of a mixture of carbon dioxide (CO 2 ) and nitrogen (N 2 ), with a small amount of carbon monoxide (CO) has been known to increase shelf life and also produce a bright red color to red meat, such as beef, and the like. It seems that customers have the perception that the bright red color is indicative of freshness and enhanced flavor and therefore are more likely to purchase such a product. [0003] The food to be treated is usually placed in a tray, such as a Styrofoam tray, wrapped with transparent plastic film, and then placed in a barrier bag. The interior of the bag is flushed with the modified atmosphere of gases to get rid of oxygen in the food tray. Typically, an oxygen absorber sachet is inserted within the modified atmosphere to get rid of any residual oxygen entrapped in the tray. When the packages are delivered to the store or other place of sale or use, personnel remove the tray of food from the package and place the food on a refrigerated shelf to preclude or minimize spoilage prior to cooking. [0004] The Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have approved the addition of 0.4% carbon monoxide gas to the modified atmosphere used during the packaging of meat, fish and poultry. Trays of such foods are presently packaged in a modified atmosphere which comprises gas volumes in the range of 70% Co 2 and 30% N 2 , and a small amount of CO on the order of 0.4%. The CO reacts with moisture in the meat to enhance its red color and is particularly effective in enhancing the red color of beef, and the like. When the meat is exposed to the CO for a considerable length of time, the red carboxyhemoglobin color of the food product becomes the predominate color. This color is relatively stable so that, when the treated meat is cooked, the inside of the piece of meat does not change its color, but remains a bright red. This phenomenon is, however, not desirable to many consumers who have the mistaken impression that the meat is undercooked and is too rare. SUMMARY OF THE INVENTION [0005] The present invention has been arrived at in order to overcome the undesirable features of the prior art and is primarily intended to further treat the meat so that, upon cooking, the interior of the meat does not retain the earlier enhanced red color. The novel results obtained by the invention are brought about through the use of various compounds of cuprous chloride or cuprous bromide for absorbing the small amount of carbon monoxide from the packaged food product. DESCRIPTION OF PREFERRED EMBODIMENTS [0006] In one preferred embodiment, the invention contemplates the use of various halogen cuprous compounds such as cuprous chloride, cuprous bromide, cuprous sulfate, or in combination of aluminum tri-chloride, or tri-bromide, and preferably cuprous aluminum tetrachloride (CuAlCl 4 ). The compounds can be deposited on a macro-reticular resin, or charcoal, or suspended in polystyrene beads and packed into gas permeable sachets. When assembled with the meat that has been packaged in the modified atmosphere of CO 2 , N 2 and CO and wrapped in plastic wrap, or treated paper, etc., the sachet will begin to absorb carbon monoxide from the surrounding atmosphere within the package. By the time that the sachet absorbs all of the CO in the modified atmosphere within the package, only a few molecular layers of red carboxyhemoglobin will have been formed on the surface of the meat, without any deep penetration into the inside portion of the meat. The outer surface of the meat does, however, acquire the desired red color. The result of this treatment is that, upon cooking of the meat, the outside surface, and the inside portion thereof, will take on the usual brown color which occurs in cooked meat that has not been treated with the foregoing processes. [0007] The carbon monoxide permeable sachet containing the cuprous chloride compound can be added to the external package of food in the modified atmosphere and protected with barrier plastic wrap to minimize oxygen from the surrounding air from reaching the packaged food. The food can be packaged in a tray, and the tray is wrapped with micro-perforated plastic film and placed within the barrier bag which contains the modified atmosphere. [0008] A further feature of the present invention is the provision of a dual compartment sachet having an oxygen absorber in one compartment and a carbon monoxide absorber in the other compartment. [0009] It is also contemplated that a single compartment, gas permeable, sachet can contain both an oxygen absorber and a carbon monoxide absorber. [0010] The amount of cuprous chloride compound to be placed in the sachet will, of course, depend upon the weight and/or volume of the packaged food. It has been found that one gram of the compound will be sufficient to treat a kilogram of beef, and similar meat products. This amount is also variable dependent upon the time of exposure to the carbon monoxide during the packaging operation. [0011] An experiment for confirming the effect of the cuprous chloride will be described next. 25 ml of concentrated hydro-chloride was diluted with distilled water in a 250 ml flask with a suitable stopper to obtain 100 ml of 3 mol hydro-chloride aqueous solution. To the solution, 16 g of anhydrous cuprous chloride was added to obtain 1.6 mol cuprous chloride solution in 3 mol hydro chloride aqueous solution. The solution exhibited deep green in color. When the gaseous carbon monoxide was bubbled in the mixture, the cuprous chloride in the mixture reacted with the carbon monoxide to form water soluble Cu(CO)Cl(H 2 O) 2 . Through this reaction, it was possible to determine an amount of carbon monoxide in a given gas mixture absorbed by the cuprous chloride. Several syringes containing gas mixtures with different carbon monoxide contents were prepared. 30 ml of 1.6 mol cuprous chloride solution was sucked into each of the syringes. After attaching a cap to each syringe, each syringe was vigorously shaken to promote the reaction between the cuprous chloride and the carbon monoxide. It was necessary to shake the syringe vigorously, as carbon monoxide is almost insoluble in water. Within 30 seconds, the carbon monoxide completely reacted with the cuprous chloride. A volume of remaining gas in the syringe was measured, and compared with the volume of the original gas to determine the amount of the carbon monoxide absorbed by the cuprous chloride. Through this experiment, it was found that the 1.6 mol cuprous chloride solution can react with the gaseous carbon monoxide in a 1:1 volume ratio, i.e. 1 ml of solution versus 1 ml of carbon monoxide. [0012] In summary, the foregoing description provides for four related inventions: [0013] 1. The use of cuprous chloride in any of various forms as a packaging agent in combination with the modified atmosphere during packaging of CO 2 , N 2 and CO, is believed to be a novel invention. [0014] 2. The use of a sachet containing a cuprous chloride compound, in combination with packaged meat that has been packaged while in an atmosphere of CO 2 , N 2 and CO, is believed to be a novel invention. [0015] 3. The use of a sachet with two compartments, one filled with an oxygen absorber and the other with a carbon monoxide absorber is believed to be a novel invention. [0016] 4. The use of a single sachet containing both an oxygen absorber and a carbon monoxide absorber is believed to be a novel invention. [0017] The foregoing descriptions describe the invention in the form of particular uses and embodiments but it is to be understood that the following claimed subject matter defines the metes and bounds of the invention and is intended to cover the disclosed invention and equivalents thereof.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of application Ser. No. 11/726,154, filed Mar. 21, 2007, which is a continuation-in-part to PCT Application PCT/US/2006/043666 filed on Nov. 10, 2006 which claims benefit of priority to Provisional Application Ser. No. 60/735,580 filed Nov. 12, 2005. BACKGROUND OF THE INVENTION [0002] The present invention relates to disposable cleaning tools. More particularly, the present invention describes an economical disposable cleaning pad with desired dust wiping and trapping capability, as well as a handle. [0003] Cleaning articles of the hand duster type are typically used in households for dusting furniture, decorative articles, and the like. These cleaning articles can either be as simple as a single dusting cloth or may have a fluffy cleaning pad or brush portion made of one or more sheets for wiping off the dust from the surface of the object to be cleaned. The cloth or pad is sometimes attached to a handle, allowing the user to clean places which are hard to reach. [0004] Different types of hand dusters are manufactured and are available in the market. One of the most commonly used hand dusters is one with a brush portion made of fibers. The fibers in the brush increase the dust trapping ability of the cleaning article. [0005] U.S. Pat. No. 4,145,787, issued to Bastian et al., discloses a hand duster comprising a relatively large fluffy spherical shaped head, a handle and a wire means to retain the head towards one end of the handle. The head consists of a very large number of fine, flexible, coextensively juxtaposed fibers extending from a central region of the head. However, since the head portion of the described duster has only fibers, it is not very durable. Fibers in the head portion may get entangled or curled during the cleaning process. As a result, the head portion gets compressed and the duster becomes less effective during continued use. [0006] In another type of a cleaning article, the brush portion is made up of twisted yarns of cotton or like materials. The twisted yarns trap dust more efficiently when an adhesive oil agent, such as liquid paraffin, is applied to their surface. Moreover, these yarns are costly and hence the cleaning articles made of twisted yarns are not an economical choice for cleaning articles which are to be disposed of after one use. [0007] Cleaning articles having laminated non-woven fabric sheets are also currently manufactured. In these cleaning articles, one or more such sheets are laminated and their peripheral portions are unattached to each other, keeping these portions loose to wipe the surface of the object to be cleaned. [0008] In another variation of these cleaning articles, the peripheral portions are cut to form a duster portion having long strips. Since non-woven fabrics are good for wiping dust and are also not very expensive, these fabrics are suitable raw materials for making disposable cleaning articles. However, the cleaning articles formed in such a manner are flat and hence the desired dust trapping capability is not optimized. [0009] U.S. Pat. No. 6,813,801, issued to Tanaka et al., discloses a cleaning article having a brush portion. The brush portion of the described cleaning article is provided with two or more non-woven sheets and fiber bundle layers. In some embodiments of the cleaning articles, the non-woven sheets are provided with strips which are described as increasing the rigidity of the brush portion and preventing entanglement of the fibers. However, the use of a large number of sheets as a constituent not only increases the manufacturing cost and inventory overhead of the cleaning article, but also complicates the manufacturing process. [0010] As mentioned above, various types of cleaning articles are currently being manufactured and sold. However, a need exists for a disposable cleaning article that is less expensive to manufacture and has optimal dust wiping and trapping capability. [0011] It is therefore desirable to make disposable cleaning articles using simplified manufacturing process steps, and hence to reduce the manufacturing cost and provide an economical and durable disposable cleaning article with the desired dust wiping and trapping capability. SUMMARY OF THE INVENTION [0012] It is an object of the present invention to provide an economical and durable disposable cleaning tool. [0013] It is a further object of the invention to manufacture a cleaning tool using a reduced number of steps to simplify the manufacturing process. [0014] It is yet another object of the present invention to provide a cleaning tool with improved dust wiping and trapping capabilities. [0015] It is a further object of the present invention to provide a cleaning tool that can be stored in a minimum amount of space. [0016] The present invention discloses a disposable cleaning tool comprising a an economical disposable cleaning pad with desired dust trapping and wiping ability and an implementing means. The disclosed cleaning pad may be prepared using simplified reduced manufacturing process steps and thus has a reduced manufacturing cost. The implementing means may comprise a foldable handle. The handle may be held within the cleaning pad by means of frictional engagement. [0017] According to an embodiment of the present invention, the cleaning pad is constructed with a top sheet and a fiber bundle. In the present cleaning pad, the top sheet is folded over, forming a cleaning portion and a back portion, while at the same time providing a pocket for attachment of a handle to the cleaning pad. Depending on the configuration of the pocket, a user may alternatively insert his or her hand into the pocket for using the cleaning pad. The handle may include a hinge, or may be of two-piece construction, for convenient folding and storage. [0018] The fiber bundle is disposed on the cleaning portion of the top sheet. The fiber bundle is preferably at least partially joined to the top sheet. In this way, disaggregation or entanglement of fibers forming the fiber bundle is suppressed. The cleaning pad may additionally be provided with a bottom sheet adjacent the fiber bundle opposite the top sheet, enhancing the contact between the cleaning pad and the object which is to be cleaned. [0019] In the cleaning pad according to a first embodiment of the invention, the cleaning portion and the back portion of the top sheet are joined together forming an empty space or pocket. The empty space thus constructed is configured to provide a pocket into which a handle, a users hand or other implementing means can be inserted. The fiber bundle is also at least partially attached to the cleaning portion of the top sheet. In the cleaning pad thus constructed, the fiber bundle is partially fixed during the cleaning operation, so that the cleaning pad is of durable construction. [0020] In this configuration, the fiber bundle appears on the outermost face of the cleaning pad and can thus conform to the irregular shape of the object to be cleaned. This improved contact enhances the fine dust wiping capability of the cleaning pad. [0021] According to a second embodiment of the invention, the cleaning pad is additionally provided with a second or bottom sheet. The bottom sheet may include a plurality of strips. The bottom sheet is disposed adjacent the fiber bundle and appears as the outermost surface of the cleaning pad. The bottom sheet increases the wiping ability of the cleaning tool. While the cleaning pad is in use, the cleaning sheet wipes the dust particles, which are then trapped by the fiber bundle. [0022] In a third embodiment of the invention, the cleaning pad comprises a top sheet and a third or middle sheet, either or both having a plurality of strips, and two fiber bundles. The top sheet and the first fiber bundle are configured in the same manner as previously described for the other embodiments. In this embodiment, the middle sheet may be disposed in between the two fiber bundles thus providing greater strength and durability to the fiber bundles of the cleaning pad. The second or bottom sheet may also be included. [0023] According to a fourth embodiment the present invention, the top sheet is folded over and bonded to form two outer surfaces and two inner surfaces and a sleeve into which an implementing means is inserted. The two inner surfaces thus formed are facing each other, and the two outer surfaces are facing opposite each other. A pair of fiber bundles are provided, one disposed on each of the outer surfaces, thereby forming dual cleaning surfaces for the cleaning tool. During cleaning operations, the first fiber bundle on a first cleaning surface is usually made to come in contact with the object to be cleaned. However, the back portion also exhibits dust wiping capabilities and may be used as and when required, such as when inserting the cleaning pad into narrow spaces. Also, the cleaning pad can either be removed from the implementing means and rotated to utilize the second cleaning surface, or the handle merely rotated depending upon the configuration of the handle. The handle may also include a rotating member to flip over the cleaning pad. [0024] In a fifth embodiment of the invention of the present invention, the top sheet is folded in a generally Z-shaped configuration along the longitudinal dimension. The Z-shaped fold creates at least two (2) pockets for insertion of a handle. The top sheet is longitudinally bonded, generally along the Z-shaped fold, with a fiber bundle operatively attached to the top sheet. [0025] In a sixth embodiment of the present invention, the top sheet is bonded to the fiber bundle by two pairs of bond lines to create two separate and distinct pockets adapted to frictionally engage a handle therein. [0026] In any of the above configurations of the cleaning pad, a pocket may be formed by folding over of the top sheet. In this pocket, a user may insert his or her hand or a handle may be inserted. [0027] It is preferred that the fiber bundle is partially joined to the top sheet so that the fiber bundle moves together with the top sheet and hence the individual fibers can be prevented from being entangled or massed. The use of the second or bottom sheet can also help reduce deformation of the individual fibers of the fiber bundle. [0028] It is preferred that the top sheet, bottom sheet and the middle sheet are made of either a non-woven fabric comprising thermoplastic fibers or a thermoplastic resin film. Preferably, the fiber bundle comprises heat-fusible thermoplastic fibers. All these elements (i.e., top sheet, bottom sheet, middle sheet and the fiber bundle) can be joined to each other easily and quickly by heat fusing. If continuous thermoplastic fibers are used for forming the sheets, the non-woven fabric can be manufactured by a point bonding process, referred to as “spun bond”, to have high rigidity and elasticity. If staple thermoplastic fibers are used for forming the sheets the non-woven fabric can be manufactured by a point bonding BRIEF DESCRIPTION OF THE DRAWINGS [0029] Various other objects, features and advantages of the invention will become more apparent by reading the following detailed description in conjunction with the drawings, which are shown by way of example only, wherein: [0030] FIG. 1 is a perspective view of a cleaning tool according to a first embodiment of the present invention. [0031] FIG. 2 is a side view of the cleaning pad of FIG. 1 . [0032] FIG. 3 is a perspective view of a cleaning tool according to a second embodiment of the present invention. [0033] FIG. 4 is a side view of the cleaning pad of FIG. 3 . [0034] FIG. 5 is a perspective view of a cleaning tool according to a third embodiment of the present invention. [0035] FIG. 6 is a side view of the cleaning pad of FIG. 5 . [0036] FIG. 7 is a perspective view of a cleaning tool according to a fourth embodiment of the present invention. [0037] FIG. 8 is a side view of the cleaning pad of FIG. 7 . [0038] FIG. 9 is a perspective view of a cleaning pad according to a fifth embodiment of the present invention. [0039] FIG. 10 is an end view of the cleaning pad of FIG. 9 . [0040] FIG. 11 is a perspective view of a cleaning tool according to a sixth embodiment of the present invention. [0041] FIG. 12 is a top view of a handle that may be used to hold a cleaning pad in accordance with various embodiments of the invention. [0042] FIG. 13 , consisting of FIGS. 13A, 13B , 13 C, 13 D, 13 E and 13 F, shows various embodiments of a handle for the cleaning tool of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0043] The following terms have the following meanings as used in the context of the present invention, unless expressly indicated to the contrary: [0044] “Cleaning tool” refers to devices comprising a cleaning pad and an implementing means, which is intended to be used for cleaning, wiping or sweeping purposes. [0045] “Cleaning pad” defines the component performing cleaning, wiping or sweeping, and is made of one or more sheets and a fiber bundle. [0046] “Cleaning face/side/surface” refers to faces/sides/surfaces which are intended to be directed to the surface of the object to be cleaned or swept. [0047] “Fiber bundle” refers to a loosely bonded sheet of fibers. Examples of fibers include filaments, flat yarns, split yarns and the like. Unless otherwise noted, these fibers are not heat-fused to one another in the fiber bundle. [0048] “Folded over” refers to folding a sheet in a generally Z- or C-shape such that a space is created between the folds of the sheet. [0049] “Longitudinal centerline” refers to the axis or direction in the plane of a sheet which generally separates the sheet into left and right transverse portions. [0050] Strip” refers to a long, relatively narrow piece of a sheet. [0051] The present invention will now be described with reference to the accompanying drawings, wherein like numerals refer to similar components throughout the various drawings. The drawings are being used to illustrate the inventive concept, and are not intended to limit the invention to the particular embodiments illustrated. [0052] FIGS. 1 and 2 show a cleaning pad 10 according a first embodiment of the present invention comprising a top sheet 13 and a fiber bundle 16 . As shown in FIGS. 1 and 2 , the top sheet 13 comprises a cleaning portion 19 and a back portion 22 separated by a fold line 25 ; the fold line 25 having a generally C-shaped configuration. The C-shaped fold of the top sheet 13 forms a pocket 28 between the cleaning portion 19 and the back portion 22 . The fiber bundle 16 is disposed adjacent to the cleaning portion 19 . As shown in FIG. 2 , the overall length of the top sheet 13 is chosen such that, when folded, the longitudinal end 31 a of the back portion 22 opposite to the fold line 25 is not coterminous with the longitudinal end 31 b of the cleaning portion 19 (see also FIG. 4 ). It will be understood by those skilled in the art that the length of the top sheet 13 can chosen such that the edges are coterminous (see, for example, the embodiment shown in FIGS. 7 and 8 ) and that the longitudinal end 31 a can be of any length. Preferably the longitudinal end 31 a of the back portion 22 extends at least 20%, and preferably at least 50%, along the longitudinal dimension of the cleaning portion 19 as measured from the fold line 25 . [0053] Preferably, the top sheet 13 and the fiber bundle 16 are bonded together along one or more bond lines 34 . In the embodiment shown in FIG. 1 , a pair of generally parallel bond lines 34 extends along the longitudinal dimension L-L of the cleaning pad 10 , and may be comprised of either continuous or intermittent bond point(s). In this manner, the pocket 28 can be dimensioned to receive a handle 37 in a snug or interference fit to prevent slippage of the cleaning pad 10 with respect to the handle 37 during use. It will be understood by those skilled in the art that the bond line 34 can be a continuous unbroken line or comprise intermittent bond points along a generally continuous line or line segment. [0054] The embodiment of FIG. 1 also includes an optional second fold line 40 to create a flap portion 43 . The flap portion 43 may also include a segmented transverse bond line 46 along transverse direction T-T, which preferably includes an opening 49 for the handle 37 . [0055] In manufacturing the cleaning pad 10 shown in FIG. 1 , preferably the folded top sheet 13 is disposed adjacent the fiber bundle 16 , which are then joined together along the longitudinal bond line(s) 34 . Alternatively, the top sheet 13 can be disposed adjacent the fiber bundle 16 with an adhesive material or layer 52 ( FIG. 2 ) therebetween. The adhesive material 52 bonds the fiber bundle 16 to the top sheet 13 . The top sheet 13 can then be folded along the fold line 25 to create the cleaning portion 19 and the back portion 22 . The longitudinal bond lines 34 and/or the transverse bond line 46 can be provided to create the pocket 28 and/or opening 49 for the handle 37 . In addition, preferably a further bond line 55 can be placed along the longitudinal centerline to join the top sheet 13 to the fiber bundle 16 , thereby creating two (2) pockets 28 for the handle 37 . [0056] Various types of materials used to make the top sheet 13 and the fiber bundle 16 are known to a person of ordinarily skill in the art. For example, the top sheet 13 may be formed of a non-woven fabric which may include thermoplastic fibers (i.e., heat-fusible fibers). Examples of the thermoplastic fibers include: fibers of PE (polyethylene), PP (polypropylene) or PET (polyethylene terephthalate); and conjugated fibers of PE/PET or PE/PP (e.g., conjugated fibers of a core/sheath structure having a core of PP or PET and a sheath of PE). Also, the individual fibers may be constructed of two or more polymer strands co-extruded in a generally side by side configuration. The non-woven fabric may be a thermal bonded non-woven fabric, a spun-bonded non-woven fabrics or a spun-laced non-woven fabric. Alternatively, the top sheet may be formed of a thermoplastic resin film such as a PE film or a PP film. It may also be possible to form the top sheet from a laminated sheet of a non-woven fabric and a resin film. [0057] Preferably, in order to increase elasticity while still providing a durable construction, the top sheet is formed of a point bonded non-woven material referred to as “spun bond”. Alternatively a through-air bonded non-woven fabric in which the thermoplastic fibers are bonded by using heated air may be used, or a point bonded non-woven fabric made of thermoplastic staple fibers. [0058] The material of the top sheet preferably should be soft in texture and strong in tensile strength. One particularly suitable material is a spunbond-meltblow-spunbond (SMS) web, available from AVGOL Nonwoven Industries LTD., Holon, Israel. The spunbond layer is made of polypropylene fibers. Such composites provide the advantage of a fabric texture. The non-woven top sheet can also be made of other suitable cloth-like materials, e.g., spun-bond or thermal-bond non-woven web made of either polypropylene, polyethylene, polyester, bi-component fibers (polyethylene/polypropylene or polyethylene/polyester), or any combinations of these fibers. Various multiple layer configurations or fiber denier variations may be used. Another example includes hydro-entangled non-woven webs, which may contain some cotton and/or rayon fibers blending in with thermal-plastic fibers. Cellulose fibers can also be blended in at small percentages to reduce cost. Other materials for forming the top sheet 13 may include polypropylene films, co-extruded films (polyethylene and ethylene vinyl acetate), co-polymer films (polyethylene/polypropylene), and polylaminates (polypropylene non-woven and polyethylene film). [0059] The fiber bundle is preferably made of a synthetic material, such as polypropylene or polyester, manufactured of numerous individual strands into a tow. The individual fibers of the tow are generally positioned in a direction perpendicular to the longitudinal dimension of the cleaning pad. The bonding of the top sheet 13 to the fiber bundle 16 helps prevent disaggregation or entanglement of the individual fiber strands. The individual fiber strands comprising the tow may be made of any suitable materials such as PE, PP, PET, Ne (nylon), rayon, or combinations thereof. The individual fiber strands of the fiber bundles may contain fibers of different finenesses. [0060] However, the fibers forming the fiber bundle of the present invention may not be limited to individual strands or filaments. The fiber bundle may also be made of a flat yarns or split yarns. Additionally, the fibers forming the fiber bundle may be crimped. In crimped fibers, the fiber bundle becomes relatively bulky so as to form a structure capable of capturing dust easily by the crimped portions. The individual strands forming the fiber bundle 16 may be joined to the top sheet 13 in any arrangement such that the motion of the individual strands can be restrained to prevent the strands from being excessively separated or entangled, while at the same time permitting the strands to move over the top sheet 13 relatively freely, thereby exhibiting an excellent dust collecting effect. [0061] Referring now to FIGS. 3 and 4 , in a second embodiment of the present invention, the cleaning pad 10 comprises the top sheet 13 and the fiber bundle 16 . The top sheet 13 is folded over thus forming the cleaning portion 19 and the back portion 22 . The fold line 25 therebetween results in the formation of an empty space, which creates a pocket 28 along with bond lines 34 . The pocket 28 allows insertion of the handle 37 , or a users hand depending upon the transverse spacing of the longitudinally directed bond lines 31 . In this embodiment, in contrast to that shown in FIG. 1 , the flap portion is not included. Also shown in FIG. 3 , a second or bottom sheet 63 is disposed adjacent to the fiber bundle 16 opposite the top sheet 13 . The bottom sheet 63 is preferably made of the same material as the top sheet 13 , thereby simplifying the manufacturing process. In this embodiment, the fiber bundle 16 can first be integrally bonded to the bottom sheet 63 , prior to its mating with the top sheet 13 . Also shown in this embodiment, either or both of the top sheet 13 and the bottom sheet 63 may have a plurality of longitudinally spaced, transverse cuts 66 to form strips 69 (which are shown exaggerated in FIG. 4 for clarity). The cuts 66 can have any configuration, thus imparting a similar configuration to the strips 69 , such as straight, serrated, curved, elliptical, etc. [0062] In a third embodiment of the present invention, as shown in FIGS. 5 and 6 , a cleaning pad 80 comprises a top sheet 83 and two (2) fiber bundles 86 a and 86 b . Disposed between each of the fiber bundles 86 a and 86 b is a third or middle sheet 89 . Preferably, the middle sheet is made of the same material as the top sheet 83 . In this embodiment, the top sheet 83 includes the C-shaped fold line 92 . [0063] A fourth embodiment of a cleaning pad 100 according to the present invention is show in FIGS. 7 and 8 . As shown, the top sheet 103 has a length that allows it to be folded along C-shaped fold line 106 , generally at a middle portion to form two outer surfaces 109 a and 109 b , and two inner surfaces 112 a and 112 b . In this manner the longitudinal ends 115 a , 115 b of each half of the top sheet 103 are generally coterminous. The two inner surfaces 112 a , 112 b are in a face-to-face relationship and the outer surfaces 109 a , 109 b are oppositely disposed. A pocket 118 is also formed between the inner surfaces 112 a , 112 b . A pair of fiber bundles 121 a and 121 b are disposed adjacent to each of the outer surfaces 109 a , 109 b . Thus the cleaning pad 100 has two cleaning surfaces. In this way, both surfaces of the cleaning pad 100 exhibit dust wiping capabilities and may be used when cleaning narrow spaces, for example, or the cleaning pad 100 rotated to effectively double the dust cleaning capacity. Each of the cleaning surfaces may also include second sheets, which may or may not include transverse cuts and strips (not shown—see FIGS. 3 and 4 ). [0064] Referring now to FIGS. 9 and 10 , an alternative folding scheme for the top sheet in a fifth embodiment of the cleaning pad 130 according to the present invention is shown. The top sheet 133 is folded over along the longitudinal direction in a generally Z-shaped manner. Similar to the other embodiments, the top sheet 133 includes a cleaning portion 136 and back portion 139 . The Z-shaped top sheet 133 has a central region 142 formed by generally parallel bond lines 145 . The bond lines 145 also preferably bonds the fiber bundle 148 to the cleaning portion 136 of the top sheet 133 . Because bond lines 145 are preferably placed adjacent to the edges of the Z-shaped fold in the central region 142 , a plurality of pockets 151 are formed. A handle 154 having a generally U-shaped portion 157 is inserted into two of the pockets 151 in order to affix the handle 154 to the cleaning pad 130 . This is more clearly shown in FIG. 10 (which is a view taken along line X-X of FIG. 9 ). This configuration also more readily allows the handle 154 to be inserted into the pockets 151 of the top sheet 133 from either end. It will be appreciated by those skilled in the art that this fifth embodiment may include multiple fiber bundles 148 , as well as a bottom sheet and/or a middle sheet, as described in reference to embodiments shown in any of the prior embodiments, for example those shown in FIGS. 3-7 . Moreover, either or all of the top sheet 133 and any other bottom or middle sheet may have strips similar to those shown in FIGS. 3 and 4 . [0065] As shown in FIG. 11 , the cleaning pad 160 comprises a top sheet 163 bonded to the fiber bundle 166 by two (2) pairs of generally parallel bond lines 169 which creates to separate and distinct pockets 172 for receiving a pair of tines 175 of a fork-shaped handle 178 . In this way, the size of the pockets 172 can be more closely controlled so as to more tightly frictionally engage the handle 178 . Moreover, the area between the pockets 172 may be slit, such as along dotted line 181 , to allow the cleaning pad 160 to pass around obstructions, such as the spindles or other supports, and for more effective cleaning of relatively confined areas. [0066] FIG. 12 illustrates a top view of a handle 1104 that may be used to hold a cleaning pad in accordance with various embodiments of the present invention. Handle 1104 includes at least one support region 1122 , a clip 1124 , a hinge 1126 , and a grip region 1128 . A cleaning pad may be placed on the support region 1122 and can be held to the handle with clip 1124 . Alternatively support region 1122 may be inserted into the holding space of a cleaning pad. The cleaning pad can then be held together with the pad using clip 1124 . Once the cleaning is done, cleaning pad may be disposed and handle 1104 may be reused with another cleaning pad. [0067] Hinge 1126 helps handle 1104 to be folded so as to reduce the storage space. The handle can then be re-extended from its storage position when it is desired to use the cleaning tool. Grip region 1128 helps a user to hold handle 1104 . Further, handle 1104 may be sized and shaped to enable a user wipe the inside of a car window. Handle 1104 may also be sized and shaped to enable a user wipe the dashboard of a car. [0068] It is possible to adopt a variety of handle structures to permit the handle to be properly secured by the pocket of the pad while cleaning. FIGS. 13A-13E illustrate various embodiments of a handle that may be used to hold a cleaning pad in accordance with various embodiment of the present invention. [0069] FIG. 13A illustrates a handle 150 with two arms 153 . Each of the two arms has multiple frictional extensions 156 that are triangular in shape. When the arms are inserted into the holding space of a cleaning pad, the frictional extensions help the handle to hold the cleaning pad by means of frictional engagement. With this type of handle it is preferred that the center bond line discussed above be included to enhance the frictional engagement of the arms 153 . [0070] FIG. 13B illustrates a handle 160 with two arms 163 . Each of the two arms has one frictional extension. The extension is triangular in shape 166 . [0071] FIG. 13C illustrates a handle 170 with one arm 173 . The arm has multiple frictional extensions that are triangular in shape 176 . [0072] In FIG. 13D there is shown a handle 180 a generally U-shaped insertion portion 183 having a plurality, in this example six (6), of resilient loops 186 for frictional engagement with the interior spaces of the pockets. [0073] In the configuration of FIG. 13E a handle 190 has a grip portion 193 and an insert portion 196 . The insert portion 196 includes at least one, and preferably two, resilient loops 199 . When inserted into a pocket (see FIG. 7 for example) the resilient loops 199 have a slight interference fit with the interior of the pocket, helping to prevent accidental disengagement of the handle 190 from the cleaning pad. [0074] These configurations allow the handles to accommodate a wide variety of pocket sizes, thus providing manufacturing flexibility for the cleaning pads such as in the spacing and/or positioning of the bond lines. [0075] It may be desirable to increase the dust holding capability of the cleaning pad of the present invention, such as by providing an additive to either or both of the cleaning sheet or the fiber bundle. If the cleaning pad is also comprised of the middle or bottom sheets, they too can be provided with the additive. This additive can take many forms which will tend to increase the tackiness of the various components of the cleaning pad. For example, the additive may be a chemical pretreatment in which a paraffin or oil based product is applied to the sheets and/or the fiber bundle. Alternatively, or in addition thereto, the fiber bundle strands may be exposed to a corona treatment to impose and electrical charge to the fiber bundles to impart a static electrical charge which “attracts” dust and dirt particles to the cleaning pad. [0076] Various other embodiments are possible and are within the spirit of the invention. The aforementioned embodiments are simply provided for explanatory purposes, and are in no way intended to restrict the scope of the invention in any manner. The cleaning pad may be made from various kinds of materials available in the field and known to a person skilled in the art. While specific embodiments of the invention have been described in detail, it will be appreciated by those skilled in the art that various modifications and alterations would be developed in light of the overall teachings of the disclosure. Accordingly, particular arrangements described are meant to be illustrative only and not limiting as to the scope of the invention, which is to be given the full breadth of the appended claims and in any and all equivalents thereof.

1a

BACKGROUND OF THE INVENTION [0001] The present invention relates generally to agricultural implements and, more particularly, to an apparatus for recollecting residual commodity from a fill hopper of an air seeder filling system. [0002] An air seeder is an agricultural implement that is commonly used to plant usually a seed crop in a large field. Air seeders typically have centrally located hoppers for seed and fertilizer which distributes them through an air stream to individual seed rows. It is convenient to fill, easy to clean out and move. Any crop that can be grown from seeds—which might vary is size from oilseeds to corn, can be sewn by an air seeder. [0003] The seed and fertilizer hoppers are usually carried on a large cart located behind or in front of the seeder. The air stream is created by a high capacity fan mounted on the cart which blows air through pipes located under the grain and fertilizer tank. Seed and fertilizer are metered out from the hoppers by a meter wheel that is turning in a ratio set by the operator for the proper seed rate or seed density. The seeds enter the pipe in the airstream and follow the pipes which terminate in the seedbed. Openers pulled through the soil make the opening where the seeds are placed. They are made of steel in the shape of points, discs or cultivator shovels. Once placed in the seed bed, the air is blown out the opening in the soil and the seed and fertilizer remain. The seeder can then pack the soil tight to retain moisture near the seed and harrow the furrows so the field is not rough. [0004] A typical air seeder has an agricultural commodity cart (“air cart”) comprising at least one, and commonly two, three or more tanks for carrying various agricultural products like seed and fertilizer. Although not always present, commonly there is a conveyor mounted on the cart for transferring agricultural product (“commodity”) from transport vehicles into the tanks. It is commonly seen as more convenient to mount a conveyor on the cart rather than on each transport vehicle, or maneuver a portable conveyor as a separate implement altogether. [0005] The conveyor is typically mounted on a pivot mechanism configured to allow it to be moved from a transport position, where the bottom end of the conveyor is raised for transport, to an operating position where the bottom end is lowered to receive a commodity from the transport vehicle, and is typically resting on the ground. The pivot mechanism also allows the conveyor to be maneuvered so that a spout on the upper discharge end of the conveyor can be maneuvered to direct the commodity from the conveyor into the filling hatch for each tank. Cart loading conveyors commonly include a hopper at the bottom intake end to receive agricultural product from the transport vehicle. Conventional cart conveyors typically comprise simply a straight tube with an auger inside to convey the product, and the hopper is simply mounted on the lower end. [0006] It is generally desirable to clean out the hopper when changing from one agricultural product to another in order to minimize contamination of the tanks with different agricultural products. On conventional cart conveyors, it is often possible to simply rotate the hopper on the conveyor tube such that the hopper is oriented downward. The auger can then be rotated in reverse so that material in the tube falls out of the lower end of the tube and into the inverted hopper and onto the ground. Other approaches include a hopper constructed with a cleanout port in the bottom of the hopper so that the auger can be reversed and the majority of material will fall out the cleanout port onto the ground. Some manual pushing of material is typically required to completely clean out the hopper. [0007] These conventional approaches to emptying the fill hopper are generally effective in removing the residual commodity, these approaches are wasteful in that the residual product is simply casted onto the ground. To avoid this waste, many end-users will place a pail or similar collector on the ground and raise the fill hopper above the pail. To empty to the residual commodity into the pail, the fill hopper must be reoriented, i.e., tilted, so that the residual commodity runs out of the fill hopper and into the pail. This tilting of the fill hopper can be laborious and awkward as the fill hopper is generally heavy and bulky and, thus, difficult to maneuver. And, depending on the amount of residual commodity in the fill hopper, repositioning the fill hopper can be particularly cumbersome. Similarly, the pail, which is commonly a larger container, i.e., 20 L, can also be difficult to maneuver. SUMMARY OF THE INVENTION [0008] The present invention is directed to a fill hopper for an air seeder conveyor. The fill hopper is configured such that a pail can be removably mounted to the fill hopper. The pail mounts to the fill hopper so that when the fill hopper is raised and rotated, the pail will move with the fill hopper. [0009] A number of different mounting structures may be used to removably mount the pail to the hopper. In one embodiment, the hopper has hooks that enable the bail of the pail to be hung on the hopper. The hooks are positioned such that the pail is substantially horizontal, i.e., parallel to the base of the hopper, when the hopper is in the being-filled (“operating”) position. The hooks are positioned so that the pail sits tightly against the sidewall of the hopper when the hopper is in the operating position. When the hopper is rotated to an upright position, the pail remains hooked to the hopper and thus rotated from the horizontal position referenced above to a vertical or upright position. In this position, the residual commodity from the hopper will empty into the pail. After the fill hopper is empty, slack between the pail and fill hopper can be introduced by lowering the conveyor slightly and unhooking the bail from the hopper. The pail can then be emptied in a commodity saving fashion and reconnected to the fill hopper or a new pail could be hooked onto the fill hopper. [0010] Therefore, in accordance with one aspect of the invention, a hopper of a commodity conveyor apparatus for use with an agricultural implement is provided. The hopper has a bin configured to hold a volume of a granular commodity. The bin is movable between a first position at which the bin can be loaded with the granular commodity and a second position at which residual granular commodity can be recovered from the bin. The hopper further has a fill opening formed in the bin and adapted for loading the granular commodity into the bin when the bin is in the first position. A discharge opening is configured to be flow-coupled to the commodity conveyor apparatus and a pail is removably attached to the bin for recovering the residual granular commodity from the bin when the bin is in the second position. [0011] In accordance with another aspect of the invention, a commodity conveying apparatus for use with an air seeding implement is provided. The apparatus comprises a conveyor having an intake end for receiving a granular commodity and a discharge end for passing the granular commodity into a seed hopper of the air seeding implement. A feed hopper is pivotally attached to the discharge end of the conveyor, and is pivotal between a commodity conveying position and a commodity recapture position that is upright relative to the commodity conveying position. The apparatus further comprises a bucket having a handle and a catch that captures the handle for removably attaching the bucket to the feed hopper. The catch maintains attachment of the bucket to the feed hopper when the feed hopper is pivoted from the conveying position to the recapture position. [0012] The invention may also be embodied in a method. The method is directed to recapturing residual granular commodity from a feed hopper of a conveying apparatus of an air seeding implement, and comprises attaching a pail to the feed hopper. The pail has an annular wall extending between an open top and a closed bottom surface collectively defining an annular interior. The method also includes tilting the feed hopper to an inclined position in which the closed bottom surface of the pail rests atop the ground and residual granular commodity in the feed hopper falls through the open top of the pail and into the annular interior of the pail. [0013] Various other features, objects and advantages of the present invention will be made apparent from the following detailed description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0014] The drawings illustrate one preferred embodiment presently contemplated for carrying out the invention. [0015] In the Drawings: [0016] FIG. 1 is an isometric view of an air cart having a cart mounted conveyor apparatus in the transport position; [0017] FIG. 2 is an isometric view of the air car with the cart mounted conveyor apparatus in the loading position; [0018] FIG. 3 is an enlarged view of a free end of the conveyor apparatus showing a fill hopper with a pail removably attached thereto according to the present invention; [0019] FIG. 3A is a partial exploded view of the fill hopper taken along line 3 A- 3 A of FIG. 3 ; [0020] FIG. 4 is a top plan view of the fill hopper; [0021] FIG. 5 is a side elevation view of the fill hopper in an operating position; [0022] FIG. 6 is a side elevation view of the conveyor apparatus with fill hopper rotated to an upright position to place the hopper-mounted pail atop the ground; and [0023] FIG. 7 is a side elevation view of the conveyor apparatus with the fill hopper further rotated to empty residual commodity into the pail. DETAILED DESCRIPTION [0024] FIGS. 1-2 illustrate a commodity cart loading conveyor apparatus 10 having a commodity cart 12 comprising a tank 14 . In the illustrated example, the cart 12 has three tanks 14 . It is understood however the cart 12 could have fewer than three tanks or more than three tanks. Each tank 14 has a fill hatch 16 located at a top portion of the cart 12 . The cart 12 is typically attached to a seeding tool bar (not illustrated) that is operative to receive the agricultural commodities, e.g., seed and/or fertilizer, carried in the tank 14 through a system of air ducts, and deposit the material in the soil. Such carts are typically pulled either directly behind or sometimes directly ahead of such a tool bar. [0025] The cart loading conveyor apparatus 10 has an auger 18 inside a conveyor tube 20 . As known in the art, the conveyor tube 20 provides an elongate enclosure through which commodity can be conveyed from a fill hopper 22 to the fill hatch 16 . [0026] The conveyor tube 20 is mounted to the cart 12 such that the conveyor tube 20 can be moved from a transport position, shown in FIG. 1 , to a filling position, shown in FIG. 2 . In the transport position, the conveyor tube 20 is raised off the ground 24 . In the filling position, the conveyor tube 20 is rotated outward and downward so that fill hopper 22 sits atop the ground 24 . When the fill hopper 22 is sitting on the ground 24 , commodity can be loaded into the fill hopper 22 from a transport vehicle (not shown). In the transport position, the conveyor tube 20 extends generally rearward with the fill hopper 22 raised above the ground 24 . In the filling position, the upper (discharge) end 26 of the conveyor tube 20 is centered slightly above a fill hatch 16 . In a preferred embodiment, the upper end 26 of the conveyor tube 20 includes a chute 28 that extends generally downward into the opening defined by the fill hatch 16 . The conveyor tube 20 can be moved fore and aft to align the chute 28 with the fill hatch 16 of the tank 14 to be filled. [0027] With additional reference to FIGS. 3 and 3A , the fill hopper 22 is pivotally attached to the lower end 30 of the conveyor tube 20 . An actuator 32 is interconnected between the lower end 30 of the conveyor tube 20 and the fill hopper 22 , and is operable to pivot the fill hopper 22 away from the conveyor tube 20 , as will be described more fully below, during emptying of the fill hopper 22 . [0028] With additional reference to FIGS. 4 and 5 , a container, which in the illustrated embodiment is a pail 34 , is removably attached to the fill hopper 22 by a pair of hooks 36 , 38 . The pail 34 has a cylindrical container 40 defined by an annular wall 42 extending from a disc-shaped base 44 to an open end 46 . Near the open end 46 of the cylindrical container 40 is attached a bail 48 . The bail 48 is attached to the cylindrical container 40 in a conventional manner and thus is movable between a lowered position in which the bail 48 rests against the outer surface of the annular wall 42 or a raised position in which the bail 48 is centered above the open end 46 , such as for carrying. The pail 34 can be mounted to the fill hopper 22 by hanging the bail 48 on the pair of hooks 36 , 38 . [0029] The fill hopper 22 is comprised of a bin 50 defined by a pair of sidewalls 52 , 54 , front wall 56 , and rear wall 58 . The walls are interconnected to form an inverted tetrahedron shaped cavity 60 . An auger 62 is rotatably mounted to the front wall 56 within the cavity 60 is operable to feed commodity from the bin 50 to the auger 18 in the conveyor tube 20 . It is desirable that the intake for a conveyor be screened to sieve the commodity and prevent entry into the cart 12 of lumps or foreign objects that could plug the tubes that carry the commodity. Accordingly, a sieve screen or grate 64 is attached to the upper end of the bin 50 . [0030] Mounted just below the sieve screen 64 is a plate 66 to which the hooks 36 , 38 are mounted. Each hook has a shank 68 that extends uprightly from the plate 66 to a bend 70 that turns downward to form a catch 72 . A gape 74 is defined between the catch 72 and the shank 68 , and is sized to receive the bail 48 when the pail 34 is hung on the fill hopper 22 . The hooks extend through a respective space (not numbered) in the sieve screen 64 . Additionally, the hooks 36 , 38 are mounted to the plate 66 so that the distance therebetween results in the pail 34 being held snuggly against the front wall 56 of the bin 50 when the pail 34 is hooked onto the fill hopper 22 , as best shown in FIG. 5 . As further shown in FIG. 5 , when the fill hopper 22 is in the filling position, e.g., the sieve screen 64 parallel to the ground 24 , the pail 34 is also oriented parallel to the ground 24 . That is, the open end 46 and the base 44 of the pail 34 are perpendicular to the ground 24 . [0031] The pail 34 latches tightly onto the bin 50 which holds the relative position of the pail 34 to the fill hopper 22 when the fill hopper 22 is rotated from the filling position shown in FIG. 5 to the upright position shown in FIG. 6 . The fill hopper 22 is rotated relative to the conveyor tube 20 by actuator 32 , which in one embodiment is a hydraulic acutator comprised of a hydraulic cylinder 76 and a ram 78 . The ram 78 is connected to a linkage 80 that is connected to rear wall 58 . The linkage 80 includes an inner arm 82 that is connected to the ram 78 and an outer arm 84 that is connected to the rear wall 58 . The inner arm 82 is connected to the outer arm 84 by a pivot pin 86 . Thus, as the ram 78 is extended, the outer arm 84 rotates downward (clockwise in the figure), which causes the bin 50 to be roated to a generally downward position. It will be appreicated that the conveyor tube 20 must be raised slightly to lift the fill hopper 22 off the ground 24 so that there is ample room between the fill hopper 22 and the ground 24 for the fill hopper 22 to rotate downward to vertically orient the fill hopper 22 . [0032] As also shown in FIG. 6 , when the fill hopper 22 is rotated to the upright position, the base 44 of the pail 34 is parallel to the ground 24 and thus conveyor tube 20 can be lowered so that the pail 34 sits on the ground 24 . In this position, the open end 46 of the pail 34 is effectively below the front wall 56 (lower wall in FIG. 6 ) of the bin 50 , which allows residual commodity in the fill hopper 22 to flow by gravity and/or counter-rotation of auger 62 into the pail 34 . [0033] Turning now to FIG. 7 , it is contemplated that the fill hopper 22 could be rotated further, which results in the fill hopper 22 being in an over-rotated or past-upright position but the pail 34 still securely seated on the ground 24 . Permitting limited over-rotation of the fill hopper 22 may improve the capture of residual commodity from the fill hopper 22 by enabling any residual commodity that is sitting against the front wall 56 of the bin 50 to be gravitationally fed into the pail 34 . [0034] After the fill hopper 22 is emptied, the conveyor tube 20 may be lowered slightly so that the otherwise snug fit between the bail 48 and the hooks 36 , 38 can be released. This allows a user to remove the bail 48 from engagement with the hooks 36 , 38 and unhook the pail 34 from the fill hopper 22 . The pail 34 can then be emptied and then hooked again to the fill hopper 22 or a new pail could be hooked to the fill hopper 22 . [0035] While the present invention has been described with respect to hooks for facilitating the temporary attachment of the pail to the fill hopper, it is understood that other types of latching structures could be used. [0036] The present invention has been described in terms of the preferred embodiment, and it is recognized that equivalents, alternatives, and modifications, aside from those expressly stated, are possible and within the scope of the appending claims.

1a

This is a continuation application of U.S. patent application Ser. No. 08/212,118, filed Mar. 14, 1994 entitled APPARATUS FOR PRODUCING MULTIPLE MOTIONS, now U.S. Pat. No. 5,474,520. TECHNICAL FIELD This invention relates generally to an apparatus capable of producing multiple motions, and more particularly an apparatus that is useful in actuation of a continuous, passive motion apparatus of the type which is particularly useful in post operative, rehabilitation therapy for a human ankle or other extremity. BACKGROUND ART The art associated with the present invention is the art of apparatus which produce motion. Various apparatus may be found in numerous different contexts, which impart motion in some form. For purposes of providing at least one context in which such an apparatus may be useful, much of the following is devoted to the context of continuous, passive motion apparatus. The present inventor has recognized several uses for the apparatus of the present invention in addition to use with or as a continuous, passive motion machine. Human joints, and muscles associated with the joints, may be weakened or traumatized as a result of disease, injury or a surgical procedure. Prolonged inactivity of the joint can be a deterrent to recovery and can result in reduced limits of joint function. Movement of the joint hastens and improves rehabilitation, but may be difficult or painful for a patient. Consequently, the art has recognized the need for machines which can provide passive exercise, operating the joints and flexing the muscles over restricted limits which may be increased as rehabilitation progresses. A variety of such apparatus has been proposed and are commonly called continuous, passive motion or CPM systems. With a CPM system it is desirable to drive a foot supporting platform not only in dorsiflexion and plantar flexion over a range of angular displacement, but also in eversion and inversion over a range of angular displacement. Preferably, a CPM machine can provide both simultaneously and in a smoothly blended, continuous motion. Apparatus proposed by the art suffers from one or both of two principal disadvantages. Several such devices generate only one motion. Others either do not permit adjustments in the angular displacement range over which the foot support platform is driven or, at best, have adjustments which are difficult for the therapist to make and/or can be varied only over a relatively narrow range. Most require an inconvenient mechanical adjustment of the apparatus. It is one object and feature of the present invention to provide a therapeutic CPM machine which imposes a continuous, passive motion upon a support platform for supporting a foot or other extremity, such as a hand, with the motion being easily controlled and varied without mechanical adjustment over a broad range of inversion and eversion angular displacement and speed, and simultaneously over a broad range of dorsal and plantar flexion angular displacement and speed. This allows a therapist to select and change, from time to time, the amplitude and speed of the angular excursions and the angle of the limits of those excursions in both the eversion/inversion direction, as well as in the dorsal/plantar flexion direction. BRIEF DISCLOSURE OF INVENTION The present invention is an apparatus which may include a support platform for supporting and/or moving an object, for example a foot, through a multiplicity of orientations about two pivot axes. A pair of independently operable actuators, preferably linear actuators, may be mounted to a base or a support frame. A support platform may be movably mounted to the support frame for permitting pivotal movement about two pivot axes, preferably a horizontal pivot axis for obtaining dorsal and plantar flexion (or analogous motions) and a second pivot axis which is perpendicular to the horizontal pivot axis for permitting eversion and inversion. A pair of drive links, each link preferably including a universal hinge at each of its ends, are preferably connected between the actuators and the support platform. One of the drive links may be connected between a first one of the actuators and the movable support platform and the other drive link may be connected between the second one of the actuators and the movable support platform. Preferably the actuators are each operated by a different, controllable position motor, such as a stepper motor, which is connected to a microprocessor control circuit which independently drives both actuators over a controllable and variable, selected range within their maximum operation ranges, for controlling the motion of the support platform about both pivot axes. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a top plan view of one preferred embodiment of the invention and also diagrammatically illustrating the connection of the control circuit. FIG. 2 is a view in side elevation of the embodiment illustrated in FIG. 1. FIG. 3 is a view in end elevation of the embodiment of FIG. 1. FIGS. 4, 5 and 6 are views in perspective illustrating differing positions of a movable support platform of the embodiment of the invention which is illustrated in FIG. 1. In describing the preferred embodiment of the invention which is illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected or to the embodiment in which the invention is utilized, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner. For example, the word "connected" or terms similar thereto are often used. They are not limited to direct connection but include connection through other elements where such connection is recognized as being equivalent by those skilled in the art. DETAILED DESCRIPTION The embodiment, illustrated in FIGS. 1-4, has a support frame 10 which is a flat base plate upon which the remaining structures may be mounted. A pair of independently operable, linear actuators 12 and 14 are mounted on the support frame 10. Each of the linear actuators 12 and 14 are independently connected to a microprocessor control circuit 16 so each may be independently operated by the control circuit 16. The preferred actuators are preferably linear actuators and are preferably identical, and therefore only the linear actuator 14 is described in further detail. While a variety of linear actuators may be used, such as hydraulic rams, compressed air or pneumatic cylinders, or a rack and pinion, the preferred linear actuator comprises a lead screw 18 which is rotatably mounted to a pair of thrust bearings 20 and 22, bolted to the support frame 10. The lead screw 18 is preferably an acme screw and is drivingly connected to a controllable position motor, such as a conventional stepper motor 24. As is known to those skilled in the art, a stepper motor is a controllable positioned motor and is actuated by pulses, each of which turn the motor through a preselected, angular displacement. Therefore, the angular position of the motor is known by the number and polarity of the electrical pulses which have been applied to the motor. The preferred stepper motor provides 200 steps per 360 degrees of rotation, and can operate as high as 16,000 steps per second. The stepper motor is, therefore, easily and accurately controlled and provides a wide range of angular velocity. As will be apparent to those skilled in the art, a variety of other controllable position motors are available for use with the actuators in place of the stepper motors. For example, a DC motor, combined with a shaft encoder, can also be used. A variety of alternative position detector systems can also be applied to embodiments of the present invention. For example, a linear encoder could be utilized, positioning, for example, a series of phototransistors along and parallel to the path of each nut member 26 and by mounting a light emitting diode upon each nut member 26 to actuate the nearby photo transistor. A nut member 26 may be threadedly engaged on the lead screw 18. A pair of rotatable wheels 28 and 30 are mounted to an axle to protrude downwardly from the nut member 26 and roll along the top surface of the support frame 10. These wheels provide a bearing which prevent rotation of the nut member 26 and also support the vertically downward component of force applied to the nut member 26. Consequently, rotation of the stepper motor 24 in one direction, translates the nut member 26 in one direction along the support frame 10, while rotation of the stepper motor in the opposite direction translates the nut member in the opposite direction. In both cases, the horizontal displacement is directly proportional to the algebraic total of the angular displacement of the stepper motor 24. Therefore, the number and polarity of the pulses applied to the stepper motors 24 and 25 determines the position of the nut members 26 and 27. The two identical linear actuators 12 and 14 are independently operable along approximately parallel axes. A movable support platform 32 may be mounted to permit pivotal movement about two pivot axes. The first pivot axis for the support platform 32 may be the axis of a clevis pin 34 which extends through a clevis 36 to pivotally mount the clevis 36 to a support block 38, which in turn may be fixed to the support frame 10. The clevis 36, support block 38 and clevis pin 34 together form a first hinge with a pivot axis which is preferably perpendicular to the parallel displacement paths of the linear actuators 12 and 14 and is approximately horizontal. A support axle 40 may be oriented perpendicularly to the clevis pin 34 and fixed to the clevis 36. The axle 40 may be pivotally connected to support platform bearings 42 and 44, which in turn are fixed to the support platform 32 so that the axis of the axle 40 provides a second axis about which the support platform 32 is free to pivot. Consequently, the bearings 42 and 44 and pivot axle 40, together with the clevis 36, form a second hinge having a pivot axis substantially perpendicular to the first pivot axis through the clevis pin 34. As a result of this mounting of the support platform 32 to the support frame 10, the inclination or pitch of the support platform 32 may be varied about the axis of the clevis pin 34 to allow for such motions as dorsiflexion and plantar flexion. Similarly, pivotal movement of the support platform 32 about the axis of the support axle 40 allows for roll of the support platform 32 to permit, for example, inversion and eversion of a foot 46, supported on the support platform 32. The foot is preferably held in place by a binding 64. The support platform 32 may be drivingly linked to the linear actuators 12 and 14 by means of a pair of drive links 50 and 52. Each of the drive links includes a universal hinge at each of its ends, such as a ball joint, universal joint, flexible connecting shaft or any other kind of joint which allows free pivotal movement in all angles of direction about a central pivot point. For example, the drive link 50 is connected to the support platform 30 by a ball joint 53 and to the nut member 26 by a ball joint 54. Such a universal hinge or joint is necessary because roll of the support platform 32 about the axle 40 for inducing eversion and inversion will cause the upper ends of both drive links 50 and 52 to move back and forth relatively closer to and further from a central, vertical plane passing through the support axle 40. In the operation of the preferred embodiment, actuation of the stepper motors 24 and 25 in the identical direction from the same initial position and for the identical displacement will vary only the inclination or pitch of the support platform 32 over a range of angles about the clevis pin 34. The nut members 26 and 27 translate horizontally from left to right, as illustrated in FIG. 3, to accomplish such motion as plantar flexion and dorsiflexion over a desired angular range. The angular limits over which the dorsiflexion and plantar flexion occur are determined by the linear displacement limits of the nut members 26 and 27, which, in turn, are determined by the angular displacement of the stepper motors 24 and 25. The roll motion for inducing inversion and eversion is a function of the difference between the linear displacements of one nut member from the other nut member along the parallel axes along which they reciprocate to provide different roll angles, as illustrated in FIGS. 5 and 6. Consequently, both inversion and eversion angles, as well as dorsiflexion and plantar flexion angles may be controlled and smoothly varied to provide a gentle rolling, pivoting movement by independently controlling, selecting and varying the linear positions of the nut members 26 and 27. Both of these motions may be simultaneously and smoothly blended by continuously displacing the nut members 26 and 27 along their respective lead screws 18 and 19 and simultaneously varying the difference between their displacements. While a variety of actuators, and particularly linear actuators, may be utilized with embodiments of the present invention, the lead screw and nut arrangement illustrated is preferred. It is simple, easily controlled, and, because of the mechanical advantage, combined with friction, forces exerted during use, for example by a foot on the support platform 32, cannot be transmitted back to cause rotation of the lead screws 18 and 19, although if necessary a stepper motor can be locked in place. The mathematical relationships relating the angular displacement of the stepper motors 24 and 25 to the pitch and roll of the support platform 32 will vary somewhat, depending on the particular embodiment of the invention which is constructed and may be determined by the application of well known principles of algebra, geometry and trigonometry or by testing to determine the particular relationship which may be used for controlling a preferred embodiment of the invention. It is desirable in some embodiments to initialize the control circuit for the particular embodiment before proceeding with motion of the support platform 32. One manner of accomplishing this is to provide a pair of microswitches 60 and 61, located, for example, at one end of the linear translation range for the nut members 26 and 27. These microswitches are connected to the microprocessor control circuit 16. Typically, upon initial actuation of the microprocessor control circuit 16, the stepper motors are rotated to translate the nut members into contact with their respective microswitches 60 and 61. Upon actuation of its microswitch, the associated nut member is stopped and when both are stopped, the microprocessor then may store in memory this initial position. Thereafter the number of pulses and their polarity, which are applied to the stepper motors 24 and 25, may be maintained in memory so that the microprocessor is continuously aware of the position of the nut members 26 and 27. Thereafter, the microprocessor drives the stepper motors 24 and 25 according to any desired control relationship to cause the nut members 26 and 27 to reciprocate back and forth along the lead screws 18 and 19 to obtain the desired motion of the support platform 32. It should be apparent that embodiments of the present invention may be utilized beyond the field of physical therapy. The present invention may be used, for example, for supporting and varying the inclination and orientation of other types of work pieces. While certain embodiments of the present invention have been disclosed in detail, it is to be understood that various modifications may be adopted without departing from the spirit of the invention or scope of the following claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a new and improved device for cracking nuts and more particularly, to a nutcracker which operates to crack nuts without scattering hulls or shells. The nutcracker of this invention may be operated without the necessity of being clamped or otherwise secured to a bench or tablet and, it is portable, light in weight, and is capable of simultaneously carrying both a supply of nuts to be cracked and a quantity of cracked nuts. The nutcracker is simple and easy to operate and prevents the scattering of hulls and shells during the cracking operation by containing the nuts in an enclosed cracking chamber, which enhances the utility of the device indoors. The nutcracker can be used to crack substantially any nut which will fit inside the cracking chamber, and may be designed and adjusted to accommodate the cracking of nuts of varying size and description. 2. Description of the Prior Art Heretofore, various devices have been developed to crack nuts, most of which are equipped with a cracking mechanism consisting of cracking jaws and at least one cracking lever. For example, U.S. Pat. No. 3,713,468 to Carol H. Walsh discloses a nutcracker having a hollow guide cylinder containing a piston which reciprocates inside the cylinder with respect to an adjustable jaw to facilitate cracking of a nut placed between the piston and the jaw. The nutcracker is lever-operated, the lever being attached to the piston in order to apply pressure on the nut to be cracked. Furthermore, in U.S. Pat. No. 2,804,111 to P. C. Burchett, a manually operated nutcracker designed essentially in the shape of a pair of pliers is disclosed, with a nutcracking chamber and a pair of jaws cooperating with a pair of levers to facilitate the necessary cracking pressure. Conventional nutcracking devices are characterized by many undesirable features. For example, nutcrackers of the piston design generally require some external stabilizing means since operation of the lever with sufficient power to crack nuts requires that the frame be clamped or otherwise firmly mounted to a strong support. Another disadvantage inherent in nutcrackers of this design is the problem of excessively cracking the nut since no means is provided for preventing the travel of the piston toward the jaw even after the nut is sufficiently cracked. Accordingly, if the shell happens to be quite hard and sufficient force is applied to crack it, this force frequently results in excessively crushing the meat in the nut. Hand nutcrackers are frequently subject to the limitation of requiring considerable pressure on the handgrip members to achieve sufficient power to crack the nut. Accordingly, nuts having thick shells such as walnuts and hickory nuts would be very difficult if not impossible to crack utilizing such devices because of the limited amount of leverage which can be realized by squeezing the handgrips together to achieve cracking. Furthermore, removal of nuts from the cracking chamber would appear to be somewhat cumbersome where positioning springs located inside the cracking chamber are used, since the springs tend to force the nut in an upward position against the upper cracking member, thereby making removal of the cracked nut difficult. Accordingly, it is an object of this invention to provide an improved nutcracker which is portable, does not require mounting or clamping to be used, and is equipped with a built-in tray to store both uncracked and cracked nuts both during the cracking operation and when the nutcracker is not in use. Another object of the invention is to provide a new and improved nutcracker having an enclosed cracking chamber which operates to prevent the scattering of hulls and shells during the cracking operation, thus enabling the nutcracker to be used inside the home, in an automobile or elsewhere under circumstances where the scattering of shells would be undesirable. A still further object of the invention is to provide a new and improved nutcracker which is equipped with an adjustable cracking lever and a rear base member which permits the cracking operation to be achieved by a sharp blow to the cracking lever rather than by an unregulated pull or jerk as in many conventional nutcracking devices. Yet another object of the invention is to provide a new and improved device for cracking substantially any nut, which is adjustable to accommodate nuts of varying sizes and shapes and to achieve a clean cracking of the nut shell or hull to enable the meat to be removed in large pieces with a minimum of crushing. Another object of the invention is to provide a new and improved nutcracker which is functional and yet pleasing in appearance, and which therefore functions as a decorative item either alone or with a supply of nuts, as well as operating efficiently to crack nuts. SUMMARY OF THE INVENTION These and other objects of the invention are provided in a nutcracker for cracking nuts without scattering hulls or shells which includes the following elements. 1. A tray for storing both cracked and uncracked nuts; 2. A base member, including a cracking block, adapted to seat a nut to be cracked and hold it firmly in place during the cracking operation; and 3. A cracking lever and flange combination in hinged cooperation with the base member to form a cracking chamber within which nuts may be cracked by operation of the lever without the scattering of hulls or shells. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood in view of the following description presented with reference to the accompanying drawings. FIG. 1 of the drawing is a perspective view of the nutcracker of this invention with the cracking lever in closed position; FIG. 2 is a perspective view of the nutcracker illustrated in FIG. 1 with the cracking lever in the open position ready to receive a nut for cracking; FIG. 3 is a bottom view, partially in section, of the cracking lever and base of the nutcracker illustrated in FIGS. 1 and 2, taken along lines 3--3 in FIG. 2, and more particularly illustrating the interior of the cracking lever and flange assembly and the cracking head and cracking block of the base; FIG. 4 is a sectional view of the cracking lever and base illustrated in FIG. 3 of the drawing and taken along lines 4--4 in FIG. 3, more particularly illustrating the relationship of one of the cracking lever flanges to the cracking lever and cracking block of the base; FIG. 5 is a top elevation of the base illustrated in FIGS. 1-4 of the drawing, more particularly showing the relationship between the cracking block nut supports, nut depression and base hinges for cooperating with the cracking lever; FIG. 6 is an elevational view, partially in section, of the interior of the cracking lever, more particularly illustrating the cracking head and the hinging relationship between the cracking lever and the forward base member which cooperates with the cracking block; and FIG. 7 is a perspective view, partially in section, further illustrating the positioning of a nut on the cracking block prior to the cracking operation. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to FIG. 1 of the drawing, the nutcracker of this invention, generally illustrated by reference numeral 1, is shown with tray 2 formed by sides 3, ends 4 and bottom 5. Base 6 is securely mounted to bottom 5 of tray 2, and is defined by cracking block 7, which is adjacent and secured to bottom 5, rear base member 8 and forward base member 9, both of which are vertically oriented and securely attached to cracking block 7. Forward base member 9 is fitted with forward base member hinges 15, and forward base member slot 16 located between forward base member hinges 15 to accommodate cracking lever hinge 14 of cracking lever 12. Forward base member aperture 10 is drilled through forward base member hinges 15 and through cracking lever hinge 14, to accommodate hinge pin 11 which hingedly joins cracking lever 12 and forward base member 9 of base 6. Cracking lever flanges 13 are secured to each side of cracking lever 12 and are downwardly extending to overlap cracking block 7, rear base member 8, and forward base member 9 to define a cracking chamber 26 (illustrated in FIG. 2). As illustrated in FIGS. 2 and 4 of the drawing, cracking lever 12 is permitted to pivot on forward base member 9 of base 6 by cooperation between forward base member hinges 15, cracking lever hinge 14 and hinge pin 11, to allow the placing of a nut 25 (illustrated in FIG. 7 of the drawing) in position for cracking on nut depression 22 and in cooperation with nut supports 23. Referring now to FIGS. 3 and 6 of the drawing, cracking head 17 is threadably positioned on cracking head bolt 19 and is equipped with cracking head flanges 18 to securely grip the top portion of nut 25 in the cracking operation. Cracking head bolt 19 cooperates in threadable relationship with cracking lever 12 to permit adjustment of cracking head 17 in order to accommodate nuts of varying sizes prior to cracking. This adjustment is accomplished by manipulating cracking head adjusting wheel 21, which is mounted on cracking head bolt support 20 in cooperation with cracking head bolt 19, and selectively raises and lowers cracking head 17 with respect to a nut 25 positioned on cracking block 7, as illustrated in FIG. 7. Cracking lever 12 is fitted with cracking lever stop 24, which mates with rear base member 8 when cracking lever 12 is in the closed position, as illustrated in FIG. 1 of the drawing. Furthermore, as heretofore noted, cracking lever flanges 13 serve to help define cracking chamber 26, formed by cooperation between cracking lever flanges 13, cracking lever 12, and base 6 to prevent shattered hulls or shells from being scattered during the cracking operation, as illustrated in FIGS. 1-4 of the drawing. FIG. 5 of the drawing particularly illustrates nut depression 22 and nut supports 23 on cracking block 7 for positioning a nut directly beneath cracking head 17. Nut supports 23 are designed to stabilize the nut and prevent it from slipping out of alignment with cracking head 17 prior to the cracking operation. In operation, a nut 25 is first placed in position in nut depression 22 of cracking block 7, in the secure grip of nut supports 23, as illustrated in FIG. 7 of the drawing. Lever 12 is then closed until contact is made between cracking head 17 and the top portion of nut 25. Cracking head adjusting wheel 21 is then manipulated to provide an opening of from about 1/2 to about 3/4 of an inch between rear base member 8 and cracking lever stop 24. When this adjustment is completed, the nut is cracked by striking cracking lever 12 sharply with the hand to cause cracking lever stop 24 to meet rear base member 8. Cracking lever 12 is then opened as illustrated in FIG. 2 of the drawing, the shattered nut removed, and another nut placed into position as noted above. Cracking head adjusting wheel 21 can be manipulated as desired to closely control the degree of cracking in order to prevent excessive crushing of the meat in the nut. It will be appreciated as heretofore noted, that cracking chamber 26 is defined by cooperation between cracking lever 12, base 6, cracking lever flanges 13 and cracking lever stop 24 to form a sealed chamber which prevents hulls and shells from scattering as pressure is brought to bear on the enclosed nut which cracks due to the force applied. It will be further appreciated that the nut is more cleanly and uniformly cracked by application of a sharp blow by the hand which is controlled as to degree of cracking, than by uncontrolled pressure, as in most conventional nutcrackers and particularly those of the piston design. This is made possible by the adjustable relationship between cracking lever stop 24 and rear base member 8 which controls the length of travel of cracking head 17, and therefore, the degree of cracking of nut 25. Accordingly, the extent of cracking of nut 25 can be quite easily controlled by simply manipulating cracking head adjusting wheel 21, which in turn determines the degree of movement or travel of cracking head 17 with respect to cracking block 7, in breaking the nut. While the nutcracker of this invention was developed primarily for cracking pecans, it is understood that substantially any nut can be cracked in the device. It is also preferred to utilize wood, and maple wood in particular, as the material of construction when cracking pecans, since it has been found that wood not only enhances the appearance of the nutcracker but is also sufficiently strong to accommodate the stress necessary to achieve cracking of the pecan. However, should it be desired to crack nuts having heavier shells than the pecan, such as walnut or hickory nuts, the nutcracker herein disclosed can be built of heavier wood, or in the alternative, metal framing, in order to accommodate sufficient cracking stress. Accordingly, substantially any nut known to those skilled in the art may be cracked by the nutcracker of this invention, depending upon the material of construction selected. Referring again to FIGS. 1 and 2 of the drawing, it is apparent that the nutcracker of this invention can be easily cleaned by simply removing hinge pin 11 from registration with forward base member aperture 10 in forward base member hinges 15 and lifting cracking lever 12 away from base 6. Nut supports 23 are also removable to permit thorough cleaning of cracking block 7, and nut depression 22 in particular. It will be appreciated that while cracking lever 12 may itself be threaded to receive cracking head bolt 19, it is preferred to use a nut embedded in cracking lever 12 and adapted to threadably receive cracking head bolt 19.

1a

BACKGROUND OF THE INVENTION The present invention relates to a method and apparatus for regulating the filling force of elastically deformable particulate materials which constitute the fillers of cigarettes, cigarillos, cigars and/or other rod-shaped articles which, in turn, constitute or form part of smokers' products. More particularly, the invention relates to improvements in a method and apparatus for adjusting the feed of tobacco or other smokable particulate material in cigarette making and analogous machines for the purpose of insuring that the pressure (filling force) which the confined particulate material applies against the internal surface of the tubular wrapper of a cigarette or the like will be maintained within a desired range. Still more particularly, the invention relates to improvements in a method and apparatus for regulating the quantity of elastically deformable particulate smokable material in a stream which is about to be draped into a web of cigarette paper or the like to constitute the filler of a continuous rod which is thereupon severed to yield discrete cigarettes or analogous rod-shaped articles of unit length or multiple unit length. The definition "smokable particulate material" embraces natural tobacco, reconstituted tobacco, artificial tobacco made of cellulose or the like, and mixtures of such substances. The material can be rendered particulate by shredding, slitting, tearing or by resorting to any other suitable comminuting technique. The rod-shaped articles which contain smokable particulate material may constitute plain or filter tipped cigars, cigarillos or cigarettes. For the sake of simplicity, the invention will be described with reference to the production of plain and filter cigarettes; however, it will be understood that the invention can be practiced in conjunction with the manufacture of any and all types of rod-shaped articles which constitute or form part of smokers' products and which involves the confinement of a continuous stream of particulate smokable material into a wrapper prior to subdivision of the resulting continuous wrapped stream into discrete rod-shaped articles of desired length. In the manufacture of cigarettes in conventional cigarette making machines, a continuous stream of tobacco is transported lengthwise on to a wrapping station where the stream is draped into a continuous web of cigarette paper. As a rule, the stream is trimmed ahead of the wrapping station and is thereby converted into a trimmed stream or filler having a constant or substantially constant cross-sectional area. The trimming device removes the surplus from an uneven side of the stream which is transported in the groove of an endless conveyor in the form of a belt, wheel or the like. It is customary to monitor the quantity of tobacco in the stream and to change the quantity of tobacco per unit length of the stream when the monitored quantity deviates from a desired value. In many instances, the monitoring means includes a source of corpuscular radiation (e.g., a source of beta rays) and an ionization chamber. It is also known to employ monitoring devices which embody a system of capacitors. The quantity of tobacco per unit length of the stream can be changed by resorting to one or more trimming or equalizing devices with rotary knives which are movable relative to the stream to remove a variable quantity of tobacco, i.e., a quantity which is a function of the difference between the measured quantity and the desired quantity of tobacco per unit length of the stream. Alternatively, the quantity of tobacco in the stream can be varied by adjusting the distributor which draws tobacco from a source of supply and converts the withdrawn tobacco into a continuous stream. As a rule, the distributor is designed to convert withdrawn tobacco particles into a relatively wide and thin sliver or carpet which is thereupon converted into a narrow stream. The aforementioned adjustment may involve regulation of the rate at which the distributor draws tobacco particles from the source of supply. The desired or preferred mode of operation of those parts of a cigarette making machine which form the continuous tobacco stream is such that each finished article (plain cigarette) contains a predetermined quantity for tobacco particles. The weight of the filler of a cigarette cannot be reduced below a predetermined minimum value; therefore, and in order to achieve savings in tobacco, the manufacturers of cigarettes strive to produce cigarettes wherein the weight of the tobacco filler matches or is only slightly above the minimum permissible weight. However, two cigarettes of identical weight (the weight of the tubular wrapper is negligible and can be disregarded) can exhibit different characteristics, especially as concerns the "feel" of the cigarette in the hand of a smoker. Thus, a cigarette wherein the weight of the filler matches a desired value can create the impression of a densely packed article by offering a pronounced resistance to deformation in response to the application of a pinching or squeezing force against the exterior of the wrapper. Such cigarettes are preferred by a great majority of the smokers. On the other hand, a cigarette wherein the weight of the filler is identical with the weight of a "densely packed" cigarette can create the impression of a soft and readily deformable rod whose wrapper will yield to minute finger pressure. The differences between "densely packed" and "soft" cigarettes are attributable to the condition of tobacco particles which constitute the filler. The main factor is the elasticity of tobacco particles and such elasticity, in turn, depends on the length of tobacco particles (shreds) and/or the crimp of the particles. Thus, a cigarette wherein the filler consists of relatively long shreds which exhibit a pronounced crimp will invariably create the impression of a densely packed product when compared with a cigarette having a filler of identical weight but containing a higher percentage of short tobacco and/or straight (uncrimped) shreds. Therefore, in addition to monitoring the quantity (weight) of tobacco per unit length of the stream (normally a trimmed stream or filler) which is to be draped into a web of cigarette paper, many manufacturers of tobacco further resort to measurement of the filling force of the filler of a finished cigarette, i.e., to the testing of cigarettes in order to ascertain the force with which the compacted filler of a cigarette bears against the internal surface of its wrapper. The results of such measurements are used to vary the quantity of tobacco per unit length of the stream, i.e., to insure that a cigarette whose filler consists of short tobacco and/or only slightly curled or crimped tobacoo will contain more tobacco than a cigarette wherein the filler consists of tobacco particles which are crimped and constitute or include a high percentage of long shreds. Of course, and even if the filler consists of highly satisfactory (long and crimped) tobacco particles, the quantity per unit length of the stream cannot be reduced to such an extent that the weight of the filler of a cigarette would be less than the minimum permissible weight (i.e., less than the lower threshold value of the acceptable range of weights). The monitoring of filling force of the fillers of cigarettes is normally carried out in a laboratory. Such monitoring involves the testing of a relatively small percentage of the total output of a cigarette maker and is desirable not only when the maker processes different types of tobacco but also when the maker is set to produce a given brand of cigarettes wherein the filler consists of a given type of tobacco. The reason is that, even during such mode operation, the quality of tobacco particles which form the stream is likely to undergo rather pronounced changes, i.e., the length of the shreds and/or the extent of crimp of the shreds is likely to undergo long-range variations above and below the desired optimum value. The presently known methods of ascertaining the filling force of fillers in cigarettes are time-consuming and must be practiced by resorting to skilled labor. Moreover, and since the samples are withdrawn at intervals and must be transferred into a laboratory, the known methods do not allow for immediate or practically immediate adjustment of the filling force when the measured filling force is unsatisfactory. It is further known to equip a cigarette making machine with apparatus which can automatically ascertain the filling force of successive increments of a continuous tobacco stream. Reference may be had to U.S. Pat. No. 3,595,067 granted July 27, 1971 to von der Lohe et al. The apparatus which is disclosed in this patent can ascertain the filling force of a filler prior to subdivision of the wrapper filler into discrete cigarettes. Moreover, the apparatus can achieve accurate measurements of the filling force. However, the nature of measurements and of the signals which are indicative of the measured value of the filling force is such that the results of measurements cannot be readily utilized for automatic adjustment of the machine for the purpose of maintaining the filling force of the fillers of cigarettes within a desired range. OBJECTS AND SUMMARY OF THE INVENTION An object of the invention is to provide a novel and improved method of ascertaining the filling force of the fillers of cigarettes or the like in such a way that the results of tests can be readily utilized for adjustment of the quantity of particulate material in the fillers when the measured filling force deviates from a desired filling force. Another object of the invention is to provide a method which can be resorted to for ascertaining the filling force of fillers of successive or selected discrete rod-shaped articles, of the entire output of a machine for the mass-production of cigarettes or the like, or of a desired percentage of the total output. A further object of the invention is to provide a novel and improved method of regulating the quantity of smokable particulate material in a stream which is to be converted into the fillers of cigarettes or the like for the purpose of insuring that the filling force of tobacco in the cigarettes will match or closely approximate a desired optimum filling force. An additional object of the invention is to provide a novel and improved apparatus which can be utilized for the practice of the above outlined method and which can automatically adjust the quantity of tobacco and/or other smokable material in the fillers of cigarettes or analogous rod-shaped articles in order to insure that the filling force of the filler of each article will match or closely approximate an optimum value. Another object of the invention is to provide the apparatus with novel and improved means for simultaneously ascertaining the filling force of plural rod-shaped articles. A further object of the invention is to provide the apparatus with novel and improved means for adjusting the quantity of particulate material in the fillers of finished articles in dependency on several factors including the filling force of the fillers. Another object of the invention is to provide an apparatus which can be readily incorporated in existing machines for the mass-production of plain or filter tipped cigarettes, cigars or cigarillos. An additional object of the invention is to provide an apparatus which is relatively simple, which requires little or no attention on the part of the attendants, and which can be readily adjusted to select the desired filling force. An ancillary object of the invention is to provide the apparatus with novel and improved means for evaluating the results of measurements of the filling force of the fillers of cigarettes or the like. One feature of the invention resides in the provision of a method of processing elastically deformable particulate material, especially tobacco (e.g., tobacco shreds which are to be converted into fillers of plain or filter tipped cigarettes). The method comprises the steps of converting smokable material into a continuous stream (e.g., a filler stream of the type formed in a cigarette making machine for wrapping in cigarette paper), moving the stream lengthwise, compacting the moving stream and applying around the moving compacted stream a continuous wrapper whereby the material of the compacted stream tends to expand and exerts a force against the interior of the applied wrapper (for example, the compacting step can be carried out in the wrapping mechanism of a cigarette making machine wherein a rod-like filler stream of tobacco shreds is transported by a garniture during draping of a web of cigarette paper therearound), subdividing the moving wrapped stream into discrete rod-shaped articles of unit length or multiple unit length while the filling force is on the increase, at least at times, toward a final value, measuring the filling force in at least some articles with a delay which follows the completion of the subdividing step and is long enough to allow the filling force to reach a value sufficiently close to the final value for ascertainment of the final value on the basis of the measured value of the filling force, and regulating the quantity of material in the stream prior to wrapping as a function of variations of the measured value of the filling force. The regulating step includes reducing the quantity of material when the measured value of the filling force increases and vice versa. The aforementioned delay is at least one second and preferably more than three seconds; this insures that the filling force increases to a value which matches or is sufficiently close to the final value prior to start of the measuring or testing step. During the interval between severing and testing, the articles can be provided with rod-like components, e.g., with filter plugs or mouthpieces and can be stacked or otherwise arrayed in orderly fashion for further processing and/or for introduction into the testing station. The measuring step may include testing a fraction of the total number of articles which the trapped stream yields as a result of the subdividing step. For example, discrete articles which are obtained as a result of the subdividing step can be conveyed along a predetermined path (e.g., in the form of a single row wherein the articles move sideways); the measuring step then comprises testing each n-th article of the row, preferably by removing each n-th article from the row and transferring the removed article to the testing station. The testing step may comprise directing a stream of pressurized fluid (e.g., compressed air) against the exterior of the wrappers of the articles which are chosen for testing and monitoring the extent of deformation of the wrappers under the action of the fluid stream. In accordance with a presently preferred embodiment of testing selected (e.g., n-th) articles, the measuring or testing step comprises testing successive increments of articles and generating first signals denoting the filling force of each tested increment of an article under test. The method then further comprises (or preferably comprises) the step of generating a second signal denoting the average intensity or another characteristic of first signals which are obtained on testing of a given article, and the regulating step then comprises varying the quantity of material in the stream as a function of the extent of deviation of the intensity of each second signal from a reference signal of predetermined or variable intensity. The measuring step may comprise simultaneously testing a plurality of articles; the testing step then preferably comprises simultaneous application of a deforming stress to a plurality of articles (e.g., a deforming stress applied by a weight which is allowed to descend onto a stack or another orderly array of articles which together constitute a plurality of articles), and monitoring the changes of the combined volume of such plurality of articles in response to the application of the deforming stress. The regulating step may comprise removing from the stream material at a rate which is a function of the measured value of the filling force. For example, the stream can be transported toward the compacting station in such a way that it contains a surplus of particulate material, and such surplus is removed by a trimming or equalizing device which is adjustable in dependency on the measured value of the filling force so that it removes more material when the measured value of the filling force increases and vice versa. Alternatively, the converting step may comprise forming a continuous carpet of sliver of smokable material (e.g., in the distributor of a cigarette making machine) and converting the carpet into the aforementioned continuous stream of smokable particulate material. The regulating step then comprises (or may comprise) varying the quantity of material per unit length of the carpet or sliver as a function of measured value of the filling force. This can be achieved by driving a conveyor of the distributor at a speed which varies as a function of variations of the measured value of the filling force. The method may further comprise the steps of generating first signals which denote the quantity of material per unit length of the moving stream and comparing the first signals with a reference signal denoting the desired quantity of material per unit length of the moving stream. The regulating step then further comprises varying the quantity of material in the moving stream when a first signal deviates from the reference signal or when the average value of a series of first signals deviates from the reference signal. The step of generating first signals may comprise directing a beam of corpuscular radiation (e.g., beta rays) transversely of and against successive increments of the moving stream and monitoring the intensity of radiation which penetrates through the respective increments of the stream. Alternatively, the step of generating first signals may include a capacitive or other suitable measurement of the quantity of material per unit length of the moving stream. The measuring step may comprise generating third signals which denote the filling force of tested articles and the regulating step may comprise modifying the reference signal when the intensity of the third signal deviates from a predetermined value denoting a desired filling force. The arrangement is preferably such that the modifying step includes increasing the intensity of the reference signal when the intensity of the third signal is below the predetermined value, and vice versa. The modifying step is preferably interrupted when the measured quantity of material drops to a predetermined lower threshold value; this insures that the quantity of smokable material per unit length of the finished articles cannot be reduced below a minimum permissible value regardless of whether or not the filling force is higher than desired. The novel features which are considered as characteristic of the invention are set forth in particular in the appended claims. The improved apparatus itself, however, both as to its construction and its mode of operation, together with additional features and advantages thereof, will be best understood upon perusal of the following detailed description of certain specific embodiments with reference to the accompanying drawing. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a schematic plan view of a portion of a production line including a cigarette making machine and a directly coupled filter tipping machine and embodying an apparatus which is constructed and assembled in accordance with a first embodiment of the invention, the apparatus being designed to ascertain the filling force of fillers of discrete filter cigarettes; FIG. 1a is an enlarged axial sectional view of a testing device which can be utilized in the apparatus of FIG. 1 to ascertain the filling force of the fillers of discrete filter cigarettes; and FIG. 2 illustrates a portion of a production line of the type shown in FIG. 1 and a modified apparatus which is constructed and assembled for simultaneous testing of stack of filter cigarettes. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows a portion of a production line including a cigarette making machine 1 and a filter tipping machine 2 which is directly coupled to the machine 1. The machine 1 is of the type known as "GARANT" (trademark) produced by Hauni-Werke Korber & Co. KG., of Hamburg, Federal Republic Germany, and the machine 2 is of the type known as "MAX", also produced by Hauni-Werke. For the sake of clarity, FIG. 1 merely shows those component parts of the two machines which are important for full understanding of the invention. The cigarette making machine 1 comprises a distributor 3 (e.g., a distributor of the type disclosed in commonly owned U.S. Pat. No. 3,996,944 granted December 14, 1976 to Alfred Hinzmann). The distributor 3 comprises a conveyor 3A (e.g., a carded drum) for drawing elastically deformable particles of smokable material (assumed to be tobacco shreds) from a suitable source of supply 4, e.g., a magazine or a duct whose discharge end is disposed above the apex of the carded drum 3A. The distributor 3 comprises means, e.g., a customary endless apron conveyor at a converting station 6, for converting the withdrawn tobacco particles into a relatively thin and wide carpet or sliver which is thereupon converted into a continuous stream 7 containing a surplus of tobacco particles. The stream 7 is narrow and its cross-sectional area exceeds the cross-sectional area of the filler of a finished cigarette. The means for transporting the stream 7 in the direction of arrow 7A comprises an endless belt conveyor 7B which advances the stream 7 past a material removing station accommodating a regulating unit here shown as a trimming or equalizing device 12. The device 12 comprises one or more rotary knives 10 which are movable at right angles to the direction of transport of the stream 7 to remove the surplus and to convert the stream 7 into a trimmed stream of filler 7a ready to be wrapped into a web 11 of cigarette paper or the like. The device wherein the trimmed stream or filler 7a is confined in the web 11 is shown at 8; this device comprises means for compacting or condensing the filler 7a so that it constitutes a rod which tends to expand and thereby exerts a force against the internal surface of the tubular wrapper*. In a manner known per se, the web 11 is drawn off a bobbin 9 and one of its marginal portions is coated with adhesive which is supplied by a conventional paster. The wrapping device 8 comprises a customary garniture which folds the marginal portions of the web over each other so that the marginal portions adhere to each other and form an elongated seam extending lengthwise of the resulting continuous cigarette rod 16 (wrapped stream 7a). The wrapping device 8 may further comprise or may be associated with a conventional sealer which promotes the setting of adhesive in the seam by cooling the seam if the adhesive is a hotmelt and by heating the seam if the adhesive is a wet adhesive which sets in response to the application of heat. The aforementioned belt conveyor 7B is preferably made of foraminous material and travels along a suction chamber which causes the particles of the streams 7 and 7a to adhere to the respective surface of the conveyor 7B during transport to the wrapping device 8. The equalizing device 12 further comprises a reversible motor 13 which can move the knife or knives 10 toward or away from the conveyor 7B to thereby change the quantity of tobacco particles per unit length of the stream 7a. The removed surplus is preferably returned to the source of supply 4 in a manner not specifically shown in FIG. 1. The reference character 14 denotes a control circuit which transmits appropriate signals to the motor 13 in order to move the knife or knives 10 toward or away from the path of movement of the stream 7. A trimming or equalizing device which can be used in the cigarette making machine 1 is disclosed, for example, in commonly owned U.S. Pat. No. 3,261,366 granted July 19, 1966 to Willy Richter et al. The means for monitoring the quantity of tobacco per unit length of the stream 7a upstream of the wrapping device 8 comprises a detector 17 including a source 18 of corpuscular radiation (e.g., beta rays) and an ionization chamber 19. The parts 18 and 19 are disposed opposite each other at the opposite sides of the path for the stream 7a, and the ionization chamber 19 transmits signals whose intensity or another characteristic is proportional to the intensity of corpuscular radiation which penetrates through successive increments or unit lengths of the continuously moving stream 7a. The signals at the output of the ionization chamber 19 are transmitted to the corresponding input of an integrating circuit 21 whose output transmits a signal (denoting the actual quantity of tobacco per given length of the stream 7a) to the input a of a signal comparing stage 22. The input b of the signal comparing stage 22 receives a reference signal which is transmitted by a preferably adjustable source 23 of reference signals (e.g., a potentiometer). The reference signal which is applied to the input b of the signal comparing stage 22 denotes the desired (optimum) quantity of tobacco particles per given length of the stream 7a. The connection between the output of the source 23 and the input b of the signal comparing stage 22 comprises a signal modifying circuit 92 (preferably a subtracting circuit) which can modify the reference signal in dependency on the monitored filling force of finished rod-shaped articles. The output c of the signal stage 22 transmits a signal which represents the difference between the intensities of signals transmitted to the inputs a and b of the stage 22, and such output signal is transmitted to the control circuit 14 for the motor 13 to effect appropriate adjustment of the knife or knives 10 in dependency on the monitored quantity of tobacco in the stream 7a. The adjustment is such that the knife or knives 10 are moved upwardly (as viewed in FIG. 1) when the monitored quantity of tobacco particles in the stream 7a is less than the desired quantity, and vice versa. In other words, the control unit 14 insures that the quantity of tobacco in the stream 7a matches or closely approximates the quantity which is denoted by the reference signal furnished to the input b of the signal comparing stage 22. The cigarette making machine 1 further comprises a device 24 (commonly known as cutoff) which severs the continuous cigarette rod 16 at regular intervals so that the rod 16 yields a file of discrete plain cigarettes 20 of unit length or multiple unit length. It is assumed that each cigarette 20 is of unit length. The cutoff 24 comprises one or more orbiting knives which move forwardly (arrow 7A) at the speed of the rod 16 during severing and thereupon move backwards on their way into renewed severing engagement with the rod 16. A suitable cutoff is disclosed in commonly owned U.S. Pat. No. 3,518,911 granted July 7, 1970 to Helmut Niemann et al. Successive plain cigarettes 20 are propelled into successive flutes of a rotary drum-shaped row forming conveyor which forms part of the filter tipping machine 2 and is mounted at a row forming station 26. The conveyor converts the single file of plain cigarettes 20 into two rows A and B wherein the cigarettes move sideways and wherein each cigarette 20 of the row A is in axial alignment with but is spaced from a cigarette 20 of the row B. The gaps between pairs of coaxial cigarettes 20 of the rows A and B are shown at 25; the width of such gaps at least equals but preferably at least slightly exceeds the length of a filter mouthpiece or plug 27 of double unit length. These filter plugs are supplied by a filter making machine 28 which includes means for supplying a single row of registering filter plugs 27 to an inserting station 29 where each plug enters the gap 25 between two aligned cigarettes 20 of the rows A and B so that each plug 27 constitutes one component of a group of three coaxial rod-like components including two plain cigarettes 20 and a plug 27 therebetween. The filter tipping machine 2 further comprises or is associated with a device 31 which supplies a single file of adhesive-coated uniting bands 32 serving to connect each filter plug 27 with the adjacent end portions of the respective plain cigarettes 20 so as to convert the respective group into a filter cigarette 20A of double unit length. The attachment of uniting bands 32 to the respective groups takes place at a station 33 downstream of the inserting station 29 (as considered in the direction of movement of cigarettes 20 forming the rows A and B). The manner in which the uniting bands 32 are formed by coating a continuous web of artificial cork or the like with adhesive and by severing the web to yield discrete uniting bands is well known in the art. Reference may be had to commonly owned U.S. Pat. No. 3,962,957 granted June 15, 1976 to Alfred Hinzmann. The means for convoluting each uniting band 32 about the respective filter plug 27 and the inner end portions of the corresponding plain cigarettes 20 is installed at a rolling station 35 which is located downstream of the station 33 and may accommodate an apparatus of the type disclosed in the commonly owned U.S. Pat. No. 3,527,234 granted Sept. 8, 1970 to Alfred Hinzmann. For example, the rolling station 35 may accommodate a rotary drum-shaped conveyor which advances the groups (each of which carries a uniting band) past a stationary or mobile rolling surface which defines with the drum a gap having a width less than the diameter of a filter plug 27. This causes the groups to rotate about their respective axes whereby the uniting bands 32 are convoluted around the filter plugs 25 and the inner end portions of the associated plain cigarettes 20. The thus obtained filter cigarettes 20A of double unit length are severed seriatim by a rotary disk-shaped knife 37 so that each cigarette 20A yields two coaxial filter cigarettes 20B of unit length. The knife 37 is installed at a severing station 36. The filter cigarettes 20B of the row A are thereupon inverted end-for-end by a turn around device 38, e.g., a device of the type disclosed in commonly owned U.S. Pat. No. 3,583,546 granted June 8, 1971 to Gerhard Koop. The device 38 places the inverted cigarettes 20B of the row A between the non-inverted cigarettes 20B of the row B so that the filter plugs 220B of all cigarettes 20B face in the same direction and the inverted and non-inverted cigarettes 20B form a single row C which advances downwardly, as viewed in FIG. 1, i.e., all cigarettes 20B move sideways and are in accurate register with each other. The cigarettes 20B which form the row C are transported on to a packing machine PM (e.g., a machine of the type disclosed in commonly owned U.S. Pat. No. 3,805,477 granted Apr. 23, 1974 to Friedel Kruse et al.), or to another processing station. In accordance with a feature of the invention, there is further provided a withdrawing or transferring device 41 which can remove selected (n-th) cigarettes 20B from the row C at a withdrawing station or transfer station 41 at which the row C advances in the flutes of a rotary drum-shaped conveyor 53. The withdrawing or transferring device 42 comprises a timer 43 which effects the withdrawal of each nth (e.g., each 1000th or 5000th) cigarette 20B from the path for the row C. The signal at the output of the timer 43 is transmitted to a solenoid-operated valve 46 which directs a jet of compressed air against the end face of the adjacent cigarette 20B in the row C to thereby transfer such cigarette onto the upper reach of a belt conveyor 54 serving to deliver the thus withdrawn cigarette to the testing station. The valve 46 is installed in a conduit 52A which communicates with a suitable source 52 of compressed air, and the orifice of the nozzle of the valve 46 faces the adjacent end faces of cigarettes 20B in the row C, i.e., of cigarettes in the flutes of the conveyor 53. The timer 43 comprises a disk 47 which is driven in synchronism with moving parts of the filter tipping machine 2 and has an annulus of pulse generating pins 48 travelling past a proximity switch 49 which transmits signals to a control circuit 44 via amplifier 51. The step-down ratio between the prime mover (not shown) of the filter tipping machine 2 and the shaft 47A of the disk 47 is selected in such a way that the valve 46 expels from the row C each nth cigarette 20B, e.g., each 1000th or 5000th cigarette of the row C. The belt conveyor 54 derives motion from the prime mover of the filter tipping machine 2 and is sufficiently long to insure that the cigarettes 20B which have been chosen for testing remain on its upper reach for a selected interval of time so that the length of the interval which elapses between the compacting of the filler of such cigarette in the wrapping device 8 (or between the separation of the respective cigarette from the rod 16 by a knife of the cutoff 24) exceeds a predetermined minimum interval, e.g., at least one second but preferably three or more seconds. The testing or measuring device 56 receives selected cigarettes 20B from the discharge end 58 of the belt conveyor 54 and is designed to ascertain the filling force of the fillers of cigarettes 20B which are delivered thereto by the conveyor 54. The purpose of the delay which is achieved by causing the selected cigarettes 20B to travel with the upper reach of the belt conveyor 54 is to insure that the filling force of tobacco which is confined in such cigarettes increases sufficiently to reach, during testing, a value which is identical with or close to the final value. At any rate, the aforementioned interval should be long enough to enable the measuring or testing device 56 to ascertain the momentary filling force of the filler of the tested cigarette at a time when the measured value of the filling force is sufficiently close to the final value so that one can ascertain the final value of the filling force or that one can estimate such final value with a degree of certainty which is sufficient to allow for appropriate automatic adjustment of the quantity of tobacco in the stream 7a as a function of deviations of the final filling force from a desired or predetermined optimum value. The filling force at one end of each cigarette 20B is also reduced as a result of severing by the knife 37; therefore, the distance between the station 36 and the testing device 56 should be sufficient to enable the filling force to increase to the aforediscussed value which is identical with or at least close to the final value. The testing or measuring device 56 has a funnel-shaped inlet 57 wherein an oncoming filter cigarette 20B descends in such a way that the filter mouthpiece 220B is located at the lower end. The inlet 57 is located at a level above a ring-shaped testing nozzle 63 the details of which are shown in FIG. 1a. The nozzle 63 defines a vertical passage 63A wherein the cigarette 20B descends and the nozzle is further formed with a narrow annular clearance 64 which communicates with the passage 63A and receives a compressed gaseous testing fluid (preferably air) from a source 59 by way of a conduit 59A containing an electrically controllable shutoff valve 61 and a preferably adjustable flow restrictor 62. Compressed air which flows from the annular clearance 64 into the passage 63A deforms the tubular wrapper 320B of the cigarette 20B while the cigarette descends in the passage 63A, and the extent of deformation of the wrapper 320B (against the opposition of the confined compacted tobacco filler) is indicative of the filling force of the filler, i.e., of the force with which the compacted and confined filler bears against the internal surface of the wrapper 320B. The diameter of the passage 63A (and hence the inner diameter of the annular clearance 64) slightly exceeds the diameter of the wrapper 320B in undeformed condition of the cigarette. It can be said that, as the cigarette 20B descends in the passage 63A, successive increments of its wrapper 320B are formed with ring-shaped constrictions (not specifically shown in FIG. 1a) which are identical if the filling force of the entire tobacco filler is constant or whose diameters vary in dependency on variations of the filling force of the filler in a direction from the lower toward the upper end of the tobacco-containing portion of the cigarette 20B in the passage 63A. The flow restrictor 62 is adjusted in such a way that the extent of deformation of the wrapper 320B in the nozzle 63 is within the elastic range of the material of the filler, i.e., that the filler expands (the constriction disappears) immediately or shortly after the cigarette leaves the nozzle 63. Thus, the tested cigarette again constitutes or resembles an elongated rod of constant diameter. Such selection of pressure of the testing fluid is particularly desirable if the tested cigarettes 20B are to be further processed, e.g., by admitting them into the magazine of the packing machine PM for introduction into soft or flip-top packs. As mentioned above, the extent of deformation of a portion of the wrapper 320B under the action of compressed testing fluid flowing from the annular clearance 64 into the passage 63A is indicative of the filling force of the corresponding portion of the filler. Therefore, by ascertaining the degree or extent of deformation, one can ascertain the filling force of the filler at the time the respective cigarette 20B descends in the nozzle 63. In order to ascertain the extent to which the wrapper 320B is deformed, one can monitor the pressure of testing fluid immediately downstream of the clearance 64 or in the clearance proper because such pressure varies with the extent to which the wrapper is deformed and allows testing fluid to flow from the clearance 64 into and from the passage 63A. Another mode of ascertaining the extent of deformation of the wrapper 320B is shown in FIG. 1a. Thus, the nozzle 63 is formed with an annular groove 66 which communicates with the passage 63A immediately downstream of the locus of communication between the passage 63A and the clearance 64. The pressure of fluid which flows into the groove 66 is a reliable indicator of the extent of deformation of the corresponding portion of the wrapper 320B. Thus, the filling force is more pronounced when the pressure in the groove 66 is higher, and vice versa. The valve 61 can be opened, via amplifier 67, by the output signal which is transmitted by a reflection type photoelectronic cell 68 installed in a conical portion 65 of the nozzle 63 at a level below the groove 66. The photodiode 69 of the cell 68 transmits a signal when the light beam issuing from the light source 71 of the cell 68 impinges upon white cigarette paper (i.e., the valve 61 can remain closed to prevent testing when the filter mouthpiece 220B of a cigarette 20B advances past the cell 68 provided, of course, that the convoluted uniting band 32 does not reflect a sufficient amount of light onto the photosensitive surface of the diode 69). The cell 68 insures that the valve 61 is open only during that interval when a selected cigarette 20B descends in the passage 63A of the nozzle 63. A conduit 72 connects the annular groove 66 with a transducer 73 (e.g., a diaphragm transducer of the type disclosed in commonly owned U.S. Pat. No. 3,412,856 granted Nov. 26, 1968 to Albert Esenwein). The transducer transmits electric signals to a summing amplifier 81 shown in FIG. 1. The filter plug 220B of a selected cigarette 20B which advances beyond the discharge end 58 of the belt conveyor 54 and descends in the inlet 57 and thereupon advances through the passage 63A descends onto the upper side or surface of a mobile stop 74 here shown as an arm which is attached to a vertically reciprocable toothed rack 76. The rack 76 is reciprocable in suitable bearings 76A, 76B and meshes with a pinion 77 which is driven by a reversible electric motor 78 by way of a belt transmission or the like. The motor 78 is mounted in or on the frame of the machine 2 or 1 and receives start, stop and reverse signals from an amplifier 79 of conventional design. The arrangement is such that the motor 78 is started in a direction to move the rack 76 and the arm 74 downwardly, as viewed in FIG. 1, when the input a of the amplifier 79 receives a signal from the output of the photodiode 69 of the cell 68. As mentioned above, the diode 69 transmits such signal when the cell 68 detects the presence of white wrapping material in the nozzle 63, i.e., when the testing operation is to begin. The motor 78 then drives the pinion 77 at a constant speed so that the cigarette 20B whose filter mouthpiece 220B rests on the arm 74 descends at a preselected speed and the testing fluid which issues from the clearance 64 deforms successive increments of the tubular wrapper 320B. The fluid which flows along the wrapper 320B enters the groove 66 and flows through the conduit 72 to effect the generation of a corresponding electric signal at the output of the transducer 73, i.e., such signal is indicative of the measured filling force of successive increments of the filler in the tubular wrapper 320B. The summing amplifier 81 totalizes the signals which are transmitted by the transducer 73 in the course of a testing operation, i.e., the signal at the output of the amplifier 81 denotes the integrated value of the filling force of an entire filler. A limit switch 82 which is installed in the path of movement of the arm 74 transmits a signal when the testing operation is to be completed. Such signal is transmitted to the corresponding input of the amplifier 67 which erases the signal at the amplifier input which is connected with the photodiode 69 so that the valve 61 is closed as soon as the upper end of the cigarette 20B descends below the clearance 64 and groove 66. At the same time, the limit switch 82 transmits a signal to the amplifier 81 which transmits the integrated signal to an averaging circuit 83 whose output is connected with the aforementioned signal modifying or subtracting circuit 92 in the connection between the source 23 of reference signals and the input b of the signal comparing stage 22. The amplifier 81 is reset to zero as soon as the information which is stored therein is transmitted to the averaging circuit 83. Thus, the apparatus is ready for testing of the next selected cigarette 20B immediately after the arm 74 actuates the detector or limit switch 82. The motor 78 continues to move the arm 74 downwardly after actuation of the limit switch 82 whereby the arm 74 engages and actuates a further limit switch 84 which transmits a signal to the input b of the amplifier 79. This causes the amplifier 79 to supply the motor 78 with voltage of opposite polarity so that the motor 78 rotates the pinion 77 in a clockwise direction, as viewed in FIG. 1, and causes the rack 76 to return the arm 74 to the upper end position or starting position in which the arm is ready to intercept the next cigarette 20B which advances beyond the discharge end 58 of the belt conveyor 54. The upward movement of the arm 74 back to the starting position of FIG. 1 is preceeded by expulsion of the freshly tested cigarette 20B into an intercepting container 89, e.g., a chute which can direct freshly tested articles onto a conveyor for transport into the magazine of the packing machine PM. The transfer of freshly tested cigarettes 20B from the arm 74 into the container 89 is initiated by the signal which is generated by the limit switch 84 on actuation by the arm 74. Such signal is transmitted to the input b of the amplifier 79 (as described above) as well as to an amplifier 86 which causes a solenoid-operated valve 87 to open. The valve 87 is installed in a conduit 87A which connects the source 59 or another source of compressed air with a nozzle 88. The nozzle then discharges a blast of compressed air which propels the freshly tested cigarette 20B from the arm 74 into the container 89 before the arm 74 begins to move back toward the illustrated starting position. When the arm 74 reaches such starting position, it actuates a limit switch 91 which transmits a signal to the input c of the amplifier 79 to thereby arrest the motor 78. The output signal of the averaging circuit 83 is transmitted to the subtracting circuit 92 wherein it is deducted from the reference signal which is transmitted by the source 23 of reference signals. The output signal of the subtracting circuit 92 constitutes the corrected reference signal and is transmitted to the input b of the signal comparing stage 22. Thus, the knife or knives of the equalizing device 12 are moved toward the conveyor 7B for the tobacco stream 7 when the filling force increases so that more tobacco is removed and, consequently, the finished cigarettes contain less tobacco. When the measured value of the filling force decreases, the knife or knives 10 of the equalizing device 12 are moved in the opposite direction, namely, away from the conveyor 7B, so that more tobacco remains in the stream 7a and the quantity of tobacco in the cigarettes 20 is increased. The subtracting circuit 29 has a lower threshold value for its output signal, i.e., the intensity of the output signal cannot decrease below such threshold value. This insures that the weight of the filler in each cigarette at least equals the prescribed minimum permissible weight. The averaging circuit 83 insures that the position of the knife or knives 10 is not changed in response to excessive deviation of filling force of a portion of the filler in a cigarette 20B from the desired value. In place of the illustrated ring-shaped testing nozzle 63, the filling force can also be measured in a different way. For example, it may be advantageous to ascertain the elastic deformation of a wrapped portion of the rod 16 by photoelectronic means in a manner as disclosed in British Pat. No. 1,422,991. Another mode of regulating the quantity of material in the stream 7a includes adjustment of the mass of tobacco in the carpet or sliver which is formed by the distributor 3 of the cigarette making machine 1. The control connection between the signal comparing stage 22 and an adjustable variable-speed transmission 93 for the tobacco supplying conveyor 3A or another conveyor of the distributor 3 is indicated by a broken line 94. The details of such controls are adequately shown in U.S. Pat. No. 2,729,213 granted Jan. 3, 1956 to William C. Broekhuysen et al. so that a detailed description of such mode of regulating the quantity of tobacco in the stream 7a is not necessary. FIG. 2 shows a modified apparatus which differs from the embodiments of FIGS. 1 and 1a essentially in that, instead of testing discrete cigarettes for determination of the filling force of tobacco which is contained therein, the testing device 156 of the modified apparatus can simultaneously test a predetermined number of cigarettes which are confined in a container, a so-called charger or tray. This mode of testing can be resorted to for ascertainment of the filling force of tobacco in all cigarettes which issue from the filter tipping machine. Those components of the production line of FIG. 2 which are identical with or analogous to corresponding components of the production line of FIG. 1 are denoted by similar reference characters plus 100. A comparison with FIG. 1 shows that the cigarette making machines 1, 101 and the filter tipping machines 2, 102 are of identical construction all the way to the respective turn-around devices 38 and 138. The turn-around device 138 of FIG. 2 deviates from the turn-around device 38 in that it tip-turns the cigarettes 120B of the row B and places the inverted cigarettes between the non-inverted cigarettes 120B of the row A. The cigarettes 120B of the row C which are transported from the filter tipping machine 102 on a conveyor belt 153 are delivered to a charger filling machine 201 which is shown schematically in plan view. A charger filling machine which is especially suited for use in the production line of FIG. 2 is known in the cigarette industry under the name "CASCADE" (produced by Hauni-Werke) and is described in detail in U.S. Pat. No. 3,308,600 granted Mar. 14, 1967 to Otto Erdmann et al. The reason that the machine 201 is especially suited for determination of filling force in a manner to be described below is that its suction head which is indicated at 202 invariably removes from the conveyor belt 153 a predetermined number of filter cigarettes 120B and sucks them upwardly into flutes which are adjacent to each other. Thus, during each filling stroke of a transfer member or pusher 203, a full row which contains a fixed number of filter cigarettes 120B is introduced into a charger 204 so that, when filled and transferred from the filling station 206 onto a belt conveyor 208 which advances in the direction indicated by arrow 207, the charger 204 invariably contains a block or stack consisting of a predetermined number of arrayed filter cigarettes 120B (e.g., 6000 or 8000 cigarettes). Since the individual rows are placed on top of each other while laterally offset by one-half of a cigarette diameter so that the individual cigarettes of one row are always deposited in the gaps between the cigarettes of the row therebelow, the filled charger 204 contains a highly homogenous block or stack which, therefore, is suited for simultaneous determination of the filling force of tobacco in all cigarettes therein. For the sake of clearer illustration of the testing device, the charger 204 downstream of the arrow 209 is turned through 180 degrees so that is can be seen in front elevation as viewed in the direction of arrow 207. The testing device 156 of FIG. 2 comprises a plate-like weight 211 whose width corresponds to the width of the cigarette stack in the filled charger 204. The weight 211 can be moved up and down by a toothed rack 212 and a pinion 213 which latter can be driven by an electric motor 216 by way of an electrically controllable clutch 214. When the filled charger 204 reaches the illustrated testing position, the input a of a control circuit 217 for the motor 216 receives a signal from a limit switch 218 which simultaneously arrests the drive for the conveyor belt 208. The control circuit 217 then supplies to the motor 216 voltage which initiates rotary movement in a direction to lower the weight 211. As soon as the weight 211 descends onto the cigarette stack in the filled charger 204, a plate-like sensor 219 (recessed into the underside of the weight 211) is displaced against the opposition of a spring 221 and thereby actuates a switch 222. This switch 222 transmits a signal to the input a of the clutch 214 whereby the power flow between the motor 216 and the pinion 213 is interrupted so that the weight 211 is released and its mass can apply a deforming stress to the cigarette stack therebelow. The distance which the weight 211 thereupon covers depends on the filling force of tobacco which is contained in the cigarettes of the stack so that one can ascertain the filling force on the basis of measurement of such distance. For the purpose of measuring the distance, the signal which is transmitted in response to closing of the switch 222 is further transmitted to the input a of a counter 223 to prepare the counter for reception of distance denoting signals at its input b. The distance denoting signals are transmitted by a stationary reflection type photoelectronic cell 224 which monitors a graduated raster 226 connected to the rack 212 and moving along the cell 224. The cell transmits a signal on detection of each graduation of the raster 226, and such signals are transmited to and counted by the counter 223. Rasters with strip-shaped graduations and associated monitoring means for measuring the distances covered by mobile parts are well known, especially in machine tools. The number of counted signals, i.e., the condition of the counter 223 after elapse of the measuring interval, is indicative of the distance covered by the weight 211 which thereby slightly reduces the height of the stack in the filled charger 204. Since this distance is a function of the filling force, it is indicative of the filling force proper. Actually, the distance is indicative of the average value of filling force of the fillers of all tested articles 20B in a charger 204. The means for terminating the measuring interval comprises a time-delay device 227 which delays the signal supplied thereto on actuation of the switch 222 and thereupon transmits the signal to the input c of the counter 223 whereby the information which is stored in the counter is transmitted to a storage 229 and the counter is simultaneously restored to its initial condition. The output signal of the time-delay device 227 is further transmitted to the input b of the control circuit 217 which thereupon supplies to the electric motor 216 voltage of opposite polarity so that the motor is started and rotates in the opposite direction. Since the output signal of the time-delay device 227 is also transmitted to the input b of the clutch 214 and has caused engagement of the clutch, the rack 212 is moved upwardly until a limit switch 228 transmits a signal to the input c of the circuit 217 to terminate the supply of energy so that the motor 216 comes to a halt. A brake, not shown, which is actuated at the same time prevents unintentional lowering of the weight 211. Furthermore, and since the signal which has been generated as a result of closing of the switch 222 disappears, further counting by the counter 223 of signals which are transmitted by the cell 224 is impossible. The limit switch 228 thereupon starts the drive means for the transporting belt 208 so that the charger 204 which contains tested articles is removed from the range of the testing device 156 and the latter is available for the next-following charger. The testing device 156 can test the contents of each and every filled charger or the contents of each n-th charger. The signal which is stored in the storage 229 and denotes the measured filling force, and which corresponds to the integrated value (comparable to average value signal furnished by the circuit 83 of FIG. 1), is again transmitted to a subtracting or modifying circuit 192 wherein it is deducted from the reference signal supplied by the source 123 of reference signals. In a manner as shown in FIG. 1, the quantity of tobacco in the stream 107a is regulated via signal comparing stage 122 in dependency on the measured filling force, namely, either by adjustment of the regulating means including the equalizing device 112 or by adjustment of the distributor 103 in the cigarette making machine 101. The integrated measured values of filling force for tobacco in cigarettes 120B which are confined in a charger 204 can be used, as in FIG. 1, for calculation of average values by means of an averaging circuit (not shown) which average values serve to influence the quantity of material in the stream 107a. If the ultimate products are plain cigarettes, the testing device 56 or 156 receives some or all of the articles which issue from the cigarette making machine 1 or 101. It is further clear that the device 56 or 156 can test the plain cigarettes 20 or 120 prior to introduction of such cigarettes into the filter tipping machine 2 or 102. The aforementioned interval of at least one second and preferably more than three seconds can be greatly exceeded. This further insures that the measured filling force is close to or matches the final filling force, namely, the filling force which is ascertained by the purchaser prior to or during smoking. An important advantage of the improved method and apparatus is that the manufacture of cigarettes can be regulated not only in dependency on the mass of tobacco (which is not a satisfactory indicator of the quality of cigarettes) but also that the regulation is influenced, in a fully automatic way, by measured values of the filling force and that the measured values denote the actually achieved filling force, i.e., the measured values at least approximate the final value of the filling force. Without further analysis, the foregoing will so fully reveal the gist of the present invention that others can, by applying current knowledge, readily adapt it for various applications without omitting features that, from the standpoint of prior art, fairly constitute essential characteristics of the generic and specific aspects of my contribution to the art and, therefore, such adaptations should and are intended to be comprehended within the meaning and range of equivalence of the claims.

1a

RELATED APPLICATION [0001] This application claims the benefit of priority under 35 U.S.C. §119(e) of U.S. Provisional Application No. 60/656,436, filed on Feb. 25, 2005, the disclosure of which is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to a fire extinguishing agent. In particular, the present invention relates to a fire extinguishing agent for extinguishing multiple classes of fires. BACKGROUND OF THE INVENTION [0003] Many metals and metal compounds are flammable. When ignited, a metal may act as the fire's fuel and may be oxidized by a number of elements and/or compounds. Most metals prone to ignite may produce fires of extremely high temperatures and may be difficult to extinguish. The classification for fires involving metals and/or metal compounds are commonly known as “Class D” fires. Examples of these metals include, but are not limited to, lithium, sodium, potassium, rubidium, cesium, francium, beryllium, titanium, uranium, and plutonium. Some metal compounds, such as, for example, alkyllithiums, Grignards and diethyizinc, are pyrophoric organometalic reagents. Most pyrophoric organometalic reagents may burn at high temperatures and may react violently with, for example, water, air, and/or other chemicals. [0004] Because these materials react to produce extremely high temperature fires and are natural catalysts, they have the ability to extract oxidizers from their surrounding environment and/or from compounds normally used as fire extinguishing agents. These oxidizing agents are not necessarily oxygen-containing compounds. Many metals, such as, for example, magnesium, sodium, lithium, and potassium, once ignited, will burn in, for example, gases containing nitrogen, chlorine, fluorine, sulfur, and/or sulfur. The gases may disassociate common fire extinguishing agents, such as, for example, carbon dioxide and Halon® to free radicals needed to support their combustion. [0005] One example of how reactive these metals are is demonstrated by the modern aircraft flare. This type of flare is not compounded from traditional oxidizers such as potassium nitrate or potassium chlorate, which are rich in oxygen, but are in fact a mixture of finely powdered magnesium and Teflon®. Teflon® is considered to be one of the least reactive materials known to man and contains no oxygen. Once ignited, however, Teflon® decomposes to release fluorine, which acts as its oxidizing agent. The reaction tends to be more vigorous and tends to produce temperatures hotter than would be possible with oxygen. [0006] When water comes into contact with some of these metals, such as, for example, lithium, sodium, potassium, and magnesium, hydrogen gas is dissociated from the water and a hydroxide radical is formed. The hydrogen gas formed by this reaction is a very combustible gas and may be often ignited by heat generated by the decomposing metal/water reaction. In such reactions, a dangerous situation may result if certain chemicals used in fire extinguishers are applied to certain types (e.g., classes) of fires. In fact, some dangerous situations are sometimes associated with the above reactions. For example, some fire fighting training manuals include warnings such as, for example, the following warning: “It is vital to know what type of extinguisher you are using. Using the wrong type of extinguisher for the wrong type of fire can be life-threatening.” [0007] When metals and/or metal compounds are shipped from one location to another, they may often be shipped in containers and/or on pallets with other types of freight, such as, for example, plastic parts and/or paper boxes. The resulting mixture of freight types, if involved in a fire, may likely require different types of fire extinguishing agents in order to effectively extinguish the different classes of fires (e.g., Class A, Class B, and/or Class D fires). [0008] Fire extinguishing agents sometimes used to safely extinguish Class D fires (e.g., those types of fires sometimes associated with metals and/or metal compounds) may not be desirable for extinguishing other classes of fires. As a result, such agents may require adherence to special procedures for effective use, such as the following procedure for using an agent sold under the trade name, “Purple K®”: “Apply the dry powder. Completely cover the burning metal with a thin layer of powder. Once control is established, take a position that is in close range. Throttle the stream with the nozzle valve to produce a soft, heavy flow. Cover the metal completely with a heavy layer of powder. Be careful not to break the crust formed by the powder. Slowly open the nozzle of the extinguisher.” [0009] When shipping a mixture of types of freight (e.g., metals and/or metal compounds, plastic materials, and/or paper boxes), however, it may not be possible to follow such rules, for example, because it may not be practical to orient the freight in a manner where freight containing metals and/or metal compounds would be positioned in such a way to allow the fire extinguishing agent (e.g., fire extinguishing powder) to cover all exposed sides of that type of freight. For example, if a container of metallic sodium were shipped, it might be loaded high on or in the middle of a built-up pallet load of other freight contained in cardboard boxes. As the cardboard boxes burn during a fire, the freight load might constantly shift and thereby re-expose the burning sodium following coverage with extinguishing powder. Further, because of sodium's low melting point, the sodium might simply melt and run out from under the powdered agent. [0010] Freight shipments sometimes referred to as “Hazardous Freight” shipments may often include a mixture of types of materials. As a result, if such a freight shipment were to catch fire, it might generate various classes of fires (e.g., Class A, Class B, and/or Class D fires). No single conventional fire extinguishing agent, however, exists that is desirable for extinguishing all such classes of fires. In most situations, for example, attempting to extinguish a mixed class fire, including a Class D fire along with a Class A and/or a Class B fire, may be futile due, for example, to the differing needs of fire extinguishing agents for different fire classes. For example, if active elements such as Halon® and/or one of the known Halon® replacement agents are used to extinguish a Class D fire, a dangerous situation might result. [0011] There may exist a need for a fire extinguishing agent that may be used to effectively and/or safely extinguish a fire including burning metals and/or metal compounds. Further, there may exist a need for a fire extinguishing agent that may be used to effectively and/or safely extinguish a fire including burning metals and/or metal compounds along with other types of burning materials. [0012] The invention may seek to satisfy one or more of the above-mentioned needs. Although the present invention may obviate one or more of the above-mentioned needs, it should be understood that some aspects of the invention might not necessarily obviate them. SUMMARY OF THE INVENTION [0013] In the following description, certain aspects and embodiments will become evident. It should be understood that the invention, in its broadest sense, could be practiced without having one or more features of these aspects and embodiments. It should be understood that these aspects and embodiments are merely exemplary. [0014] In one aspect, as embodied and broadly described herein, the invention includes a fire extinguishing agent that may include a foam and at least one inert gas combined with the foam. [0015] As used herein, the term “inert gas” means at least one gas selected from helium, neon, argon, krypton, xenon, and radon in concentrations greater than concentrations naturally occurring in air (e.g., concentrations normally associated with commercially-available bottled, inert gas). [0016] In another aspect, the invention includes a method of extinguishing a fire including a burning metal and/or a burning metal compound. The method may include combining a foam and at least one inert gas to form a fire extinguishing agent, and applying the fire extinguishing agent to the fire. [0017] According to a further aspect, the invention includes a method of extinguishing a fire including a burning metal and/or a burning metal compound and also including a burning plastic material and/or a burning paper material. The method may include combining a foam and at least one inert gas to form a fire extinguishing agent, and applying the fire extinguishing agent to the fire. [0018] In still a further aspect, the invention includes a method of extinguishing a fire including a Class D fire. The method may include combining a foam and at least one inert gas to form a fire extinguishing agent, and applying the fire extinguishing agent to the fire. [0019] In yet another aspect, the invention includes a method of extinguishing a fire including a Class D fire and at least one other class of fire. The method may include combining a foam and at least one inert gas to form a fire extinguishing agent, and applying the fire extinguishing agent to the fire. DESCRIPTION OF EXEMPLARY EMBODIMENTS [0020] Reference will now be made in detail to some possible embodiments of the invention, examples of which are outlined in this description. [0021] According to one embodiment, a fire extinguishing agent configured to extinguish a Class D fire and one or more other classes of fires such as, for example, a Class A fire and/or a Class B fire, may include a foam and one or more inert gases combined with the foam. For example, the foam may include a foam marketed by Tyco International Ltd. as “ANSUL TARGET-7®” foam. The use of other foam agents known to those having skill in the art is contemplated. Some embodiments may include foam agents that do not include foams based on fluorocarbon chemistry, such as, for example, AAAF-type foams. The one or more inert gases may include, for example, helium, neon, argon, krypton, xenon, and/or radon. For example, the fire extinguishing agent may include a conventional fire fighting foam gasified with, for example, helium and/or argon, although neon, krypton, and/or xenon may be included in the fire extinguishing agent. [0022] The foam and the one or more inert gases may be combined via any method known to those having skill in the art, such as, for example, via combining in a nozzle of a fire extinguisher agent delivery apparatus and/or combining in a fire extinguisher agent mixing conduit. The fire extinguishing agent may be applied to a fire via any methods and/or devices known to those having skill in the art. According to some embodiments, the foam and the one or more inert gases may be combined in a ratio corresponding to about 60 gallons of foam-generating solution per 400 cubic feet of inert gas. Other ratios are contemplated. [0023] Most classes of fires, including Class D fires, require fuel, an oxidizer, and heat in order to sustain combustion. Unlike most other classes of fires, however, Class D fires can sustain combustion by liberating necessary oxidizers from otherwise stable compounds, such as, for example, CO 2 and/or Halon®. Furthermore, unlike many common classes of fires, metal and/or metal compound fires may burn in oxidizers other than oxygen, such as, for example, chlorine, fluorine, and/or nitrogen. Class D fires, however, cannot burn in an inert atmosphere. The family of “true” inert or noble gases includes helium, neon, argon, krypton, xenon, and radon. Many of the inert gases may be currently thought to be too rare to be economically viable for use in a fire extinguishing agent. Further, radon is radioactive. As a result, helium and argon are two inert gases that currently appear to be desirable for use in a fire extinguishing agent according to some embodiments. [0024] Attempting to extinguish fires including burning metal(s) and/or metal compound(s) (e.g., Class D fires) using one or more inert gases alone, however, may be very difficult. For example, attempting to use an inert gas alone to deprive such a fire of its oxidizer may not be effective because maintaining coverage may be difficult since helium is lighter than the surrounding atmosphere and will quickly float off, and argon is heavier than the surrounding air and will tend settle away from the area of deployment. Furthermore, the use of conventional foams to extinguish burning metal(s) and/or metal compound(s) has proven substantially ineffective, for example, because the water in the foam reacts with the metals to liberate hydrogen and because of the extreme heat of Class D fires, the fire's reaction will continue and use the air and/or nitrogen in the foam as an oxidizer, and the fire will continue to burn. [0025] The combination of foam and inert gas may be effective because when water in the foam reacts with the metal, a hydroxide radical (not oxygen or any other oxidizer) is liberated during the reaction. Hydrogen is also liberated, but in the absence of an oxidizer (no air or nitrogen is used to generate the foam), the fire is starved out. The foam may serve to trap the inert gas and keep it positioned where it most effectively acts to extinguish the fire. [0026] Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

1a

BACKGROUND OF THE INVENTION This application is a continuation-in-part of my application Ser. No. 252,935, filed Oct. 4, 1988, abandoned Mar. 14, 1990. The present invention is directed to the field of water sprayers, and is more specifically directed to water massage apparatus which can be hand-held, for use with portable spas, in-ground spas, pool spas or the like having an interior wall including at least one receptacle into which a water jet, the term used to identify the nozzle through which a mixture of water and air is jetted, can be selectively inserted. In all spas which employ water jets, each water jet is surrounded by a casing the term used to identify the unitary assembly of separate water and air intakes through which water and air are flowed and mixed before aerated water issues from the water jet, which is received in a receptacle recessed in the spa's interior wall. However, in a pool spa or an in-ground spa, the jets are flush with the wall, and the casing extends out of the wall and is externally threaded to mate with an internally-threaded open-ended cap to provide a smooth surface at the spa wall. In a portable (above-ground) spa, the jets and casing are recessed into ports in the surface of the wall of the spa and each casing is externally threaded for mating engagement with an internally-threaded receptacle at the base of each recess. Thus, different mechanisms are required for a device such as water massage apparatus to be connected to the water jet receptacles of an in-ground or pool spa, on the one hand, and a portable spa on the other hand. Most hand-held water sprayers are adapted to be used in place of a conventional shower head in a bathtub. Such sprayers are characterized by West German Patent No. 2,028,937 to Weller, West German Patent No. 2,200,675 to Westerhoff, West German Patent No. 2,830,201 to Berenbrinker, West German Patent No. 3,506,078 to Haft, and Great Britain Patent No. 769,885 to Grohe. No mechanism is provided whereby such sprayers can be adapted for connection with the water jet receptacles of pool and in-ground spas or portable spas, much less all three. Also, since the flow of water to these sprayers is controlled by the bathtub faucets, these sprayers are not provided with separate on/off mechanisms Moreover, these sprayers are provided with jet plates or similar mechanisms designed to increase the pressure of the water as it exits the sprayer, thereby creating a massaging effect. Such an increase in pressure is unnecessary in a spa, as the water exiting the water jets is already under sufficiently high pressure to create a massaging effect. Because of the high pressure of the water exiting the water jets, it is necessary that the interior structure of any massage device connected to a spa jet be sturdy enough to withstand such pressure. Further, because all the water jets of a spa are operated by a single on/off mechanism, it is necessary that any massage device connected to a spa jet have its own separate on/off mechanism if the spa is to be used without operating the massage device. It is the solution of these and other problems to which the present invention is directed. SUMMARY OF THE INVENTION Therefore, it is the primary object of this invention to provide a water massage apparatus for use in a spa or the like wherein the spa water jet can be used as the water source. It is another object of this invention to provide a water massage apparatus in which the water pressure as it exits the head of the apparatus is substantially the same as when it enters. It is another object of this invention to provide a water massage apparatus having a minimum number of moving parts. It is still another object of this invention to provide a water massage apparatus which can be used in any spa, regardless of the positioning of the jets. It is still another object of this invention to provide a water massage apparatus which can be turned on and off separately from the water source. These and other objects of the invention are achieved by the provision of a water massage apparatus comprising a head having an inlet port and outlet apertures, a hollow adapter dimensioned to register with the casing surrounding the water jet, and a hollow replacement casing selectively engageable with the receptacle in the spa wall for replacing the casing which normally surrounds the water jet, and dimensioned to receive the proximal end of the water jet therewithin. Plain plastic tubing or a conventional pool or garden hose is attached at one end to the head and at the other end to the adapter. The head comprises a base and a cap rotatably attached to the base. The base comprises a side wall having inner and outer surfaces and an upper rim, an open top defined by the upper rim of the side wall, and a lower wall defining a closed bottom and having inner and outer surfaces. The side wall has an inlet aperture therethrough and a substantially circular lateral cross-section. An inlet port extends outwardly from the outer surface of the side wall at the inlet aperture and includes a connector for selectively connecting the head to one end of the tubing or hose. The cap is rotatably attached to the base and comprises a side wall having inner and outer surfaces and a lower rim, and an upper wall defining a closed top and having inner and outer surfaces. The side wall has a substantially circular lateral cross-section. The lower rim defines an open bottom and sealingly engages the upper rim of the base. The upper wall of the cap includes a plurality of evenly spaced-apart radial outlet apertures therein. A finger extends vertically downwardly from the lower rim of the cap and has inner and outer surfaces, the inner surface being coextensive with the inner surface of the side wall of the cap and the outer surface of the finger sealingly engaging the inner surface of the side wall of the base, the finger being dimensioned to cover the inlet aperture and defining a valve for opening and closing the inlet aperture. In one aspect of the invention, the sum of the lateral cross-sections of the outlet apertures is approximately equal to the area of the lateral cross-section of the inlet aperture. In another aspect of the invention, the inner and outer surfaces of the upper wall of the cap are substantially frusto-conical. In yet another aspect of the invention, the inlet port of the base and one end of the adapter are externally barbed to selectively engage the ends of the tubing or threaded to selectively engage the ends of the hose. In still another aspect of the invention, the exterior of the replacement casing is threaded at one end to selectively engage the internal threads of both a spa jet receptacle. In another aspect of the invention, the replacement casing and the adapter are connected to each other by connector members integral with the replacement casing and the adapter. In still another aspect of the invention, a separate connector member is provided to connect the replacement casing to the adapter. A better understanding of the disclosed embodiments of the invention will be achieved when the accompanying detailed description is considered in conjunction with the appended drawings, in which like reference numerals are used for the same parts as illustrated in the different figures. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side perspective view of the water massage apparatus according to the invention in use in a spa; FIG. 2 is a top plan view of the water massage apparatus according to the invention; FIG. 3 is a bottom plan view of the water massage apparatus of FIG. 2; FIG. 4 is a side elevational view of the water massage apparatus of FIG. 2; FIG. 5 is a cross-sectional view of the water massage apparatus of FIG. 2, taken along line 5--5 of FIG. 2; FIG. 6 is a partial cross-sectional view of the water massage apparatus of FIG. 2, taken along line 6--6 of FIG. 5; FIG. 7 is an exploded perspective view of the water massage apparatus of FIG. 2; FIG. 8 is a perspective view of a first embodiment of the adapter of the water massage apparatus; FIG. 9 is a cross-sectional view of the adapter of FIG. 8, taken along line 9--9 of FIG. 8; FIG. 10 is a perspective view of a first embodiment of the replacement casing of the water massage apparatus; FIG. 11 is a perspective view of the replacement casing of FIG. 10, taken along line 11--11 of FIG. 10; FIG. 12 is a top plan view with parts broken away of the water massage apparatus of the invention installed in a water jet receptacle of the spa shown in FIG. 1, using the adapter and the casing of FIGS. 8 and 10; FIG. 13 is a perspective view of a second embodiment of the adapter of the water massage apparatus; FIG. 14 is a cross-sectional view of the adapter of FIG. 13, taken along line 14--14 of FIG. 13; FIG. 15 is a perspective view of a second embodiment of the replacement casing of the water massage apparatus; FIG. 16 is a perspective view of the casing of FIG. 15, taken along line 16--16 of FIG. 16; and FIG. 17 is a top plan view with parts broken away of the water massage apparatus of the invention installed in a water jet receptacle of the spa shown in FIG. 1, using the adapter and casing of FIGS. 13 and 15. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to FIGS. 1 and 12, there is shown a first embodiment of a water massage apparatus 10 according to the invention, in use in a portable spa 12 having an interior wall 14 with a threaded receptacle 16 for receiving a threaded water jet casing (not shown). Water massage apparatus 10 comprises a head 20, a hollow replacement casing 24 selectively insertable into the receptacle 16 in place of the original spa casing, and a hollow adapter 22 dimensioned to register with the replacement casing 24. A conventional hollow connector 25 connects replacement casing 24 to adapter 22. A plain plastic tube 26 having ends 28 and 30 is attached at one end 28 to head 20 and at the other end 30 to adapter 22. Referring now to FIGS. 2-4 and 12, head 20 comprises a cylindrical cap 34 rotatably disposed upon a base 36. Base 36 comprises a side wall 40 having inner and outer surfaces 42 and 44, an upper rim 46, an open top 48 defined by upper rim 46, and a lower wall 50 defining a closed bottom 52 and having inner and outer surfaces 54 and 56. Side wall 40 has an inlet aperture 58 therethrough and a substantially circular lateral cross-section. An inlet port 60 extends outwardly from outer surface 56 at inlet aperture 58, and includes external annular threads or barbs 62 for selectively connecting head 20 to end 28 of tubing 26. The inner diameters to inlet aperture 58 and inlet port 60 are 7/8 inch (2.22 cm) each while the inner diameter of tubing 26 is 3/4 inch (1.91 cm.), in order to ensure proper flow-through of water through tubing 26 and inlet aperture 58 without any change in the water pressure, and in order to allow a force fit of tubing 26 over barbs 62. Also, if a conventional pool or garden hose having female threaded ends is to be used, inlet port 60 can be provided with external threads for selective mating engagement with one of the hose ends, as shown in my copending application Ser. No. 252,935, which is specifically incorporated herein by reference. Upper rim 46 of base 36 is planar adjacent outer surface 44 of side wall 40 and is angled inwardly adjacent inner surface 42 of side wall 40 to receive an O-ring 64. Base 36 also includes a first set of L-shaped locking posts 66 extending upwardly from inner surface 54 of bottom wall 50 adjacent one side of aperture 58, and a second set of L-shaped locking posts 68 extending upwardly from inner surface 54 of bottom wall 50 offset from the other side of aperture 58. A tubular mounting post 70 having internal threads 72 extends upwardly from the center of inner surface 54 of lower wall 50, for a purpose to be described hereinafter. Cap 34 comprises a side wall 80 having inner and outer surfaces 82 and 84, a lower rim 86, an open bottom 88 defined by lower rim 86, and an upper wall 90 defining a closed top 92 and having inner and outer surfaces 94 and 96. Side wall 80 has a substantially circular lateral cross-section. Inner and outer surfaces 94 and 96 are rounded adjacent side wall 80 and are substantially frusto-conical inwardly of side wall 80. A tubular extension 98 extends inwardly from the center of upper wall 90 for a purpose to be described hereinafter. Upper wall 90 also includes a plurality of evenly spaced-apart radial outlet apertures 100 therein. Outlet apertures 100 are circular in shape, and are formed by drilling through upper wall 90 with a circular bit. In the embodiment shown, there are eight apertures, although the number can be varied. In order for the pressure of the water exiting head 20 to be substantially the same as the pressure of the water entering head 20, the sum of the areas of outlet apertures 100 is substantially the same as the lateral cross-sectional area of inlet aperture 58. The frusto-conical configuration of top wall 90 directs water out of outlet apertures 100 in a concentrated flow. A finger 102 extends vertically downwardly from lower rim 86 of cap 34. Finger 102 has inner and outer surfaces 104 and 106, inner surface 104 being coextensive with inner surface 82 of side wall 80 and outer surface 106 sealingly engaging inner surface 42 of side wall 40 of base 36. Legs 108 extend downwardly from either side of finger 102. Finger 102 is dimensioned to cover aperture 58 and defines a valve for opening and closing aperture 58. Cap 34 also includes a flange 110 extending outwardly from outer surface 84 offset from lower rim 86. Flange 110 has upper and lower surfaces 112 and 114. Lower surface 114 registers with upper rim 46, while outer surface 84 of side wall 80 of cap 34 sealingly engages inner surface 42 of side wall 40 of base 36, O-ring 64 preventing water from leaking at the facing surfaces. Radial ribs 116 can be provided on outer surface 84 to improve the user's grip on cap 34. Tubular extension 98 is dimensioned to matingly receive mounting post 70. A washer 120 is then inserted in extension 98, resting on post 70, and a screw 122 is inserted therethrough to matingly engage interior threads 72 of post 70, thereby rotatably mounting cap 34 on base 36. One leg 108 is engaged by locking posts 66 when finger 102 closes aperture 58, while the other leg 108 is engaged by locking posts 68 when cap 34 is rotated to open aperture 58. Cap 34 is thereby locked in either the "off" or "on" position until rotated into the contrary position by the user. Referring now to FIGS. 10, 11, and 12, casing 24 in a first embodiment is tubular, having a substantially circular lateral cross-section, and has a receptacle end 130 and an exterior end 132. Receptacle end 130 is provided with a first set of external spiral threads 134 dimensioned to engage the internal spiral threads (such as threads 138) of a water jet receptacle of a portable spa. Exterior end 132 is provided with a second set of external spiral threads 136 for a purpose to be described hereinafter. Referring now to FIGS. 8, 9, and 12, adapter 22 in a first embodiment is tubular, having a substantially Y-shaped axial cross-section, and has wide end 140 and a narrow end 142. Narrow end 142 is provided with external annular threads or barbs 144 dimensioned to selectively engage end 30 of tubing 26. Wide end 140 is provided with an external flange 146 dimensioned to abut and register with exterior end 132 of casing 24, and two opposed sets 147a and 147b of holes positioned circumferentially and set in from flange 146. Sets 147a and 147b consist of three circular holes each and can be positioned at any point of the circumference of flange 145 as long as they are opposite one another. Sets of holes 147a and 147b are necessary to provide air-entrainment means for the entrainment of air into the water flowing through tubing 26, without which the apparatus will not function properly. Preferably, the holes have a diameter of approximately 1/8 inch (0.32 cm.) and are set in from flange 146 by a sufficient distance to allow entry of air into the tube 26 when adapter 22 is connected to casing 24 as discussed below, approximately 7/32 inch (0.56 cm.). Narrow end 142 has an inner diameter of approximately 7/8 inch (2.22 cm.) to match the inner diameter of inlet port 60. Also, if a conventional pool or garden hose is used, narrow end 42 of adapter 22 can be provided with external threads for engagement of the other end of the hose. Referring now to FIG. 12, connector 25 is tubular and is provided with internal threads 148 to selectively engage external threads 136 of casing 24 and an internal flange 150 to engage flange 146 of adapter 22. In a preferred embodiment, adapter 22, casing 24, cap 34, and base 36 are made from injection-molded ABS plastic. Connector 25 is a commercially available standard bushing, for example, the cap which is normally used to cover the casing of an in-ground spa. The width of side walls 40 and 80 and upper and lower walls 90 and 50 are generally 0.090 inch. The outer height of cap 34 (excluding finger 102) is 1.04 inches and the outer height of base 36 is 1.30 inches. Upper rim 46 of base 36 and flange 110 of top 34 have an outer diameter of 3.30 inches. Bottom rim 86 of cap 34 has an outer diameter of 3.12 inches (substantially equal to the inner diameter of bottom rim 86 of base 36). In order to use apparatus 10 in a portable spa with adapter 22 and casing 24, the original casing surrounding the water jet is unscrewed from receptacle 16 in wall 14. Receptacle end 130 of casing 24 is then placed over the proximal end of the water jet and inserted into the spa wall 14 so that external threads 134 engage internal threads 138. External threads 136 will then extend out of wall 14. Next, wide end 140 of adapter 22 is placed with flange 146 abutting exterior end 132 of casing 24 and connector 25 is placed over adapter 22 so that internal threads 148 engage external threads 136 of casing 24 and internal flange 150 engages external flange 146 of adapter 22, thereby establishing a water-tight connection between adapter 22 and casing 24. End 30 of tubing 26 can then be force fit onto barbed end 142 of adapter 22. Finally, barbed inlet port 60 is force fit into the other end 28 of tubing 26. Head 20 can then be held by the user and cap 34 rotated to the "on" position to provide a water massage to any part of the body, as shown in FIG. 1. When the use of apparatus 10 is no longer desired, cap 34 can be rotated to the "off" position. In order to use apparatus 10 in a pool spa or an in-ground spa, only adapter 22 and connector 25 are used. Adapter 22 is placed with flange 146 abutting the exterior end of the original casing and connector 25 is placed over adapter 22 so that internal threads 148 engage the external threads of the original casing. End 30 of tubing 26 can then be force fit onto barbed end 142 of adapter 22. Finally, barbed inlet port 60 is force fit into the other end 28 of tubing 26 and the user can proceed to use head 20 as previously described. Referring now to FIGS. 15, 16 and 17, casing 24' in a second embodiment is tubular, having a substantially circular lateral cross-section, and has a receptacle end 130' and an exterior end 132'. Receptacle end 130' is identical to end 130 of casing 24 and is provided with a first set of external threads 134' dimensioned to engage the internal threads (such as threads 16) of a water jet receptacle of a portable spa. Exterior end 132' is provided with an external flange 150' and a pair of opposed interior circumferential ribs 152' for a purpose to be described hereinafter. Referring now to FIGS. 13, 14, and 17, adapter 22' in a second embodiment is similar to adapter 22, having a wide end 140' and a narrow end 142'. Narrow end 142' is identical to end 142 of adapter 22 and is provided with external barbs 144' dimensioned to selectively engage an end 30 of tubing 26. Wide end 140' is similar to end 140 of adapter 22, being provided with an external flange 146' and two opposed sets 147a' and 147b' of holes positioned over flange 146' identical to sets 147a and 147b of holes in adapter 22. However, flange 146' is adapted to be received within exterior flange 150' of bushing 24', and the bottom of flange 146' is provided with opposed bayonets 160' which provide a bayonet joint means for engaging ribs 152' of bushing 24', so as to provide a watertight connection between adapter 22' and bushing 24' using integral connecting members. Adapter 22' and bushing 24' are also preferably made from injection-molded ABS plastic, and narrow end 142' of adapter 22' has an inner diameter of 7/8 inch (2.22 cm.). In order to use apparatus 10' in a portable spa adapter 22' and casing 24', the original casing surrounding the water jet is unscrewed from receptacle 16 in wall 14. Receptacle end 130' of casing 24' is then placed over proximal end of the water jet and inserted into the spa wall 14 so that external threads 134' engage internal threads 138. External threads 136' will then extend out of wall 14. Next, wide end 140' of adapter 22' is placed with flange 146' received in exterior flange 150' of casing 24' and rotated so that bayonets 160' engage ribs 152', thereby establishing a water-tight connection between adapter 22' and bushing 24'. End 30 of tubing 26 can then be force fit over barbed end 142' of adapter 22'. Finally, barbed inlet port 60' is force fit into the other end 28 of tubing 26. In order to use apparatus 10' in a pool spa or an inground spa, only adapter 22' and connector 25 are used. Adapter 22' is placed with flange 146' abutting the exterior end of the original casing and bayonets 160' received inside the original casing. Adapter 24' is then connected to the original casing using connector 25 as previously described with respect to adapter 22. End 30 of tubing 26 can then be force fit over barbed end 142' of adapter 22'. Finally, barbed inlet port 60' is force fit into the other end 28 of tubing 26 and the user can proceed to use head 20 as previously described. Thus, it will be seen that the disclosed embodiments of the present invention provides a unique water massage apparatus for use in a pool or spa or the like. Moreover, the installation and operation of the apparatus is both effective and easy to accomplish, so as to render the apparatus according to the invention convenient to users. While preferred embodiments of the invention have been disclosed, it should be understood that the spirit and scope of the invention is to be limited solely by the appended claims, since numerous modifications of the disclosed embodiment will undoubtedly occur to those of skill in the art.

1a

TECHNICAL FIELD [0001] The present invention relates to a pharmaceutical composition useful as an agent for preventing or treating allergy symptoms. More specifically, the present invention relates to a pharmaceutical composition having excellent stability of an allergen and excellent usability in terms of storage, handling, and the like, and a method for producing the same. BACKGROUND ART [0002] Current treatments for allergic diseases such as a pollen allergy are mostly symptomatic treatments with antihistamines, but recent attention has been focused on hyposensitization therapy as a possible curative treatment of allergic diseases. [0003] Most of the current preparations for specific hyposensitization therapy are subcutaneous injections, and these preparations usually must be administered for a long period of time (about 2 to 3 years). In this regard, a dosage form that can improve the quality of life (QOL) of caregivers and patients is believed to be necessary. [0004] Specific hyposensitization therapy with subcutaneous injections has problems such as a risk of anaphylactic shock, the need for administration by a healthcare professional, the need for long-term, frequent hospital visits, pain associated with injection, and the need for refrigeration storage. [0005] In contrast, liquid and tablet preparations for sublingual administration have been recently marketed in Europe and the United States and receiving attention because of their convenience and reduced side effects. [0006] However, specific hyposensitization therapy by sublingual administration of liquid preparations still has problems such as inaccuracy of the dose and the need for refrigeration storage. [0007] Specific hyposensitization therapy by sublingual administration of tablets has problems such as accidental ingestion, difficulty in controlling the dose, poor portability, and unpleasant sensation in the oral cavity due to residue. [0008] In the development of allergen preparations, it is essential that allergens are stably preserved, i.e., that the loss of the biological activity is minimized. [0009] As a technique to develop such an allergen preparation, a method that uses a lyophilized preparation containing a stabilizer and an excipient has been suggested. [0010] For example, Patent Literature 1 suggests a pharmaceutical composition containing stabilized timothy grass pollen allergen, obtained by lyophilizing a solution containing gelatin and mannitol or starch and mannitol as stabilizers. Additionally, for example, Patent Literature 2 suggests a pharmaceutical composition containing a stabilized recombinant protein of a major cedar pollen allergen, obtained by lyophilizing a solution containing mannitol as a stabilizer and acetic acid as a pH adjuster. Additionally, Patent Literature 3 suggests a pharmaceutical composition containing a stabilized recombinant protein of a major mite allergen, obtained by lyophilizing a solution containing macrogol 4000, polysorbate-80, and sucrose. [0011] However, with these conventional techniques to develop allergen preparations, it has been still difficult to stably preserve and deliver allergens due to their poor thermal stability. CITATION LIST Patent Literature [0000] Patent Literature 1: JP-T 2006-513269 Patent Literature 2: JP-B 3932272 Patent Literature 3: JP-A 2007-277094 SUMMARY OF INVENTION Technical Problem [0015] In view of the existing problems described above, the present inventors first developed a pharmaceutical composition containing a stabilized major cedar pollen allergen, by lyophilizing a solution containing gelatin and an organic acid salt as stabilizers. [0016] However, improvements were needed in the following points: gelatin may induce an allergic reaction in immunized people, possibly inducing serious side effects such as anaphylactic shock; and gelatin may be unusable depending on a raw material thereof due to a religious belief that prohibits eating products from animals such as pigs and cows. [0017] In view of the situation described above, the present invention aims to provide a pharmaceutical composition capable of stably preserving and delivering allergens having poor thermal stability without using gelatin as a stabilizer; and a method for producing the pharmaceutical composition. Solution to Problem [0018] In order to solve the above problems, the present inventors conducted intensive studies, and as a result, found that even allergens having poor thermal stability can be stably preserved and delivered by a composition containing a specific sugar, a polysaccharide, an edible polymer, and the like as additives. The present invention was accomplished based on such a finding. [0019] Specifically, the present invention relates to a pharmaceutical composition containing an allergen and additives selected from at least two groups from among group (A) consisting of polysaccharides having high formability; group (B) consisting of mono- to hexasaccharides, sugar alcohols thereof, maltodextrin, and polyvinylpyrrolidone; and group (C) consisting of viscous polysaccharides; wherein the additives have a stabilizing effect on the allergen. [0020] The pharmaceutical composition of the present invention is preferably free of water. [0021] The additive selected from the polysaccharides having high formability in group (A) is preferably at least one selected from the group consisting of pectin, dextran, starch, and pullulan. [0022] The additive selected from the mono- to hexasaccharides and sugar alcohols thereof in group (B) is preferably at least one selected from the group consisting of glucose, mannose, raffinose, trehalose, maltitol, isomalt, and sorbitol. [0023] The additive selected from the viscous polysaccharides in group (C) is preferably at least one selected from the group consisting of guar gum, tara gum, locust bean gum, xanthan gum, tamarind gum, ι-carrageenan, and gellan gum. [0024] The allergen is preferably a cedar pollen allergen protein. [0025] The pharmaceutical composition of the present invention preferably further contains an organic acid salt. [0026] Another aspect of the present invention is a method for producing a pharmaceutical composition, the method including preparing an allergen-containing preparation solution in which an allergen and additives are dissolved in water, and lyophilizing the allergen-containing preparation solution; wherein the additives have a stabilizing effect on the allergen and are selected from at least two groups from group (A) consisting of polysaccharides having high formability; group (B) consisting of mono- to hexasaccharides, sugar alcohols thereof, maltodextrin, and polyvinylpyrrolidone; and group (C) consisting of viscous polysaccharides. [0027] In the method for producing the pharmaceutical composition of the present invention, the allergen-containing preparation solution preferably has a pH in the range of 5.0 to 9.0. [0028] The present invention is described in detail below. [0029] The pharmaceutical composition of the present invention contains an allergen and additives. [0030] The additives are formed from non-gelatin materials and are edible polymers. They are ingredients as the base materials of the pharmaceutical composition of the present invention. [0031] In the pharmaceutical composition of the present invention, the additives are selected from at least two groups from among group (A) consisting of polysaccharides having high formability; group (B) consisting of mono- to hexasaccharides, sugar alcohols thereof, maltodextrin, and polyvinylpyrrolidone; and group (C) consisting of viscous polysaccharides. [0032] Use of the additives selected from at least two groups from among group (A), group (B), and group (C), i.e., combined use of multiple additives selected from at least two groups described above enables long-term and stable preservation and delivery of an allergen. The reason is assumed as follows: while additives having different physical properties such as molecular weight and solubility in water result in different three-dimensional structures formed after lyophilization and different interactions with allergens, the present invention uses multiple additives selected from two or more groups described above, whereby each additive enhances the stabilizing effect on an allergen in a synergistic manner without interfering with each other. [0033] In the pharmaceutical composition of the present invention, the additives have a stabilizing effect on the allergen. [0034] In regard to the expression “stabilizing effect on the allergen” as used herein, the additives are considered to have a stabilizing effect on an allergen when a medicament-containing composition prepared by dissolving an allergen and additives in water and removing the water by lyophilization exhibits an allergenic activity of 75% or more after being stored at 40±2° C. for 7 days. Examples of additives having the stabilizing effect on an allergen include those having high glass-transition temperatures. Additives having low glass-transition temperatures are crystallized during lyophilization, which is believed to result in the inactivation of the protein of the allergen. [0035] The “polysaccharides having high formability in group (A)” refer to polysaccharides with which a dosage form having usable properties can be obtained when an aqueous solution containing such a polysaccharide as an additive is lyophilized. [0036] Any polysaccharide can be used without limitation. For example, at least one selected from the group consisting of pectin, dextran, starch, and pullulan is suitably used. These polysaccharides are substances soluble in water, and preferably have a molecular weight of 10,000 or more. [0037] The term “molecular weight” as used herein refers to a weight average molecular weight, and is a value that can be obtained by gel permeation chromatography analysis. [0038] The pectin has a molecular weight of about 30,000 to 100,000. It is usually a polymeric polysaccharide extracted with water from citrus fruits or apples, and is composed of galacturonic acid and the methyl ester thereof. [0039] The pectin is classified into LM pectin and HM pectin, according to the degree of methyl esterification. In the present invention, either pectin may be used. However, because LM pectin forms a thermally irreversible gel in the presence of calcium ion, use of LM pectin in combination with an organic acid salt containing calcium ions is not preferred. [0040] The amount of pectin is preferably 0.1 to 20% by weight, more preferably 0.5 to 10% by weight, based on the total weight of an allergen-containing preparation solution (described later) immediately before lyophilization in the production process. With less than 0.1% by weight, an adequate dosage form as a medicinal product may not be formed after lyophilization. In contrast, with more than 20% by weight, the viscosity of the allergen-containing preparation solution will be very high, which may cause problems in the production. [0041] Usually, the dextran is a partially decomposed polysaccharide produced by sucrose fermentation with Leuconostoc mesenteroides Van Tieghem (Lactobacillaceae), and is mainly composed of D-glucose. [0042] The dextran can be used without any particular problems as long as the average molecular weight is 10,000 or more. From the viewpoint that the present invention is for medical use, dextran 40 (average molecular weight of 40,000) or dextran 70 (average molecular weight of 70,000) listed in Japanese Pharmaceutical Excipients is suitably used. [0043] The amount of dextran is preferably 0.1 to 30% by weight, more preferably 0.5 to 20% by weight, based on the total weight of the allergen-containing preparation solution immediately before lyophilization in the production process. With less than 0.1% by weight, an adequate dosage form as a medicinal product may not be formed after lyophilization. In contrast, with more than 30% by weight, the dextran may not be uniformly dispersed or dissolved in the allergen-containing preparation solution, which may cause problems in the production. [0044] In the pharmaceutical composition of the present invention, in the case where a polysaccharide having high formability selected from group (A) is pullulan, the amount thereof is preferably 0.1 to 50% by weight, more preferably 0.5 to 40% by weight, based on the total weight of the allergen-containing preparation solution immediately before lyophilization in the production process. With less than 0.1% by weight, an adequate dosage form as a medicinal product may not be formed after lyophilization. In contrast, with more than 50% by weight, the viscosity of the allergen-containing preparation solution will be very high, which may cause problems in the production. [0045] In the case where a polysaccharide having high formability selected from group (A) is starch, the amount thereof is preferably 0.1 to 50% by weight, more preferably 0.5 to 40% by weight, based on the total weight of the allergen-containing preparation solution immediately before lyophilization in the production process. With less than 0.1% by weight, an adequate dosage form as a medicinal product may not be formed after lyophilization. In contrast, with more than 50% by weight, the viscosity of the allergen-containing preparation solution will be very high, which may cause problems in the production. [0046] Group (B) consists of mono- to hexasaccharides, sugar alcohols thereof, maltodextrin, and polyvinylpyrrolidone (hereinafter also referred to as PVP). [0047] An additive selected from the mono- to hexasaccharides and sugar alcohols thereof is preferably at least one selected from the group consisting of glucose, mannose, raffinose, trehalose, maltitol, isomalt, and sorbitol. [0048] Usually, the maltodextrin is partially hydrolyzed corn or potato starch, and is a mixture of monomers, dimers, oligomers, and polymers of glucose. The percentage of each ingredient constituting the maltodextrin varies depending on the degree of hydrolysis. Accordingly, herein, partially hydrolyzed starch having a dextrose equivalent of 1 to 20 is defined as maltodextrin. [0049] The polyvinylpyrrolidone (PVP) is a synthetic polymer mainly consisting of linear 1-vinyl-2-pyrrolidone groups. [0050] The PVP is a polymer whose molecular weight varies depending on the degree of polymerization, and its property is determined based on the relative viscosity of PVP to water in the aqueous solution, which is represented by the K value of 10 to 120. [0051] From the viewpoint that the present invention is for medical use, PVP K25, PVP K30, and PVP K90 listed in Japanese Pharmaceutical Excipients are suitably used as the PVP. [0052] In the pharmaceutical composition of the present invention, the amount of the additive of group (B) is preferably 0.1 to 80% by weight, more preferably 1.0 to 80% by weight, based on the total weight of the allergen-containing preparation solution immediately before lyophilization in the production process. With less than 0.1% by weight, sufficient stability of the allergen may not be achieved after lyophilization. In contrast, with more than 80% by weight, the viscosity of the allergen-containing preparation solution will be very high, which may cause problems in the production. [0053] The viscous polysaccharides of group (C) show viscosity when dissolved in water and are not included in group (A). In other words, when an additive of group (C) is used alone, a dosage form with no problems in use cannot be obtained after lyophilization of the allergen-containing preparation solution. [0054] Any type of viscous polysaccharides may be used without limitation. For example, polysaccharides containing glucose and mannose are preferred. Examples of such polysaccharides preferably include at least one selected from the group consisting of galactomannans such as guar gum, tara gum, and locust bean gum, xanthan gum, tamarind gum, ι-carrageenan, and gellan gum. [0055] The gellan gum is a natural, linear heteropolysaccharide produced in an extracellular form from Sphingomonas elodea ; is composed of a repeating tetrasaccharide unit of glucose, glucuronic acid, glucose, and rhamnose; and is classified into native gellan gum and deacylated gellan gum depending on the presence of an acetyl group and a glyceryl group on 1,3-linked glucose residues. [0056] The native gellan gum has a gelation temperature of about 80° C., and is not suitable in the case where the allergen-containing preparation solution contains an allergen having low thermal stability. On the other hand, deacylated gellan gum is preferably used in the present invention because deacylated gellan gum does not undergo gelation unless a cation is added. [0057] The gellan gum forms a thermally irreversible gel in the presence of cations, particularly, calcium ion. Thus, use of the gellan gum in combination with organic acid salts including calcium ion is not preferred. [0058] The amount of the additive of group (C) is preferably 0.1 to 3.0% by weight, more preferably 0.5 to 2.0% by weight, based on the total weight of the allergen-containing preparation solution immediately before lyophilization in the production process. With less than 0.1% by weight, an adequate dosage form as a medicinal product may not be formed after lyophilization. In contrast, with more than 3.0% by weight, the viscosity of the allergen-containing preparation solution will be very high, or the additive may not be uniformly dispersed, thus causing problems in the production. [0059] The pharmaceutical composition of the present invention may also contain an appropriate amount of an edible polymer soluble only in water or an edible polymer insoluble in both water and organic solvents (hereinafter these edible polymers are also collectively referred to as “other edible polymers”) in combination with the above-described additives, as long as the effects of the present invention are not impaired. [0060] The amount of the other edible polymers is preferably 0.1 to 10% by weight based on the total weight of the pharmaceutical composition of the present invention. [0061] The allergen refers to an antigen to which an antibody of a person with allergic disease specifically reacts. The allergy is typically a protein. [0062] Specific examples include allergens from pollen of trees (golden acacia, red alder, white ash, American beech, birch, box elder, mountain cedar, red cedar, common cottonwood, cypress, American elm, Chinese elm, Japanese Douglas fir, sweet gum, eucalyptus, hackberry, hickory, linden, sugar maple, mesquite, mulberry, oak, olive, pecan tree, pepper tree, pine, common privet, Russian olive, American sycamore, tree of heaven, black walnut, black willow, etc.); allergens from pollen of grasses (cotton, Bermuda grass, Kentucky bluegrass, smooth brome, cultivated corn, meadow fescue, Johnson grass, cultivated oats, orchard grass, redtop, perennial rye grass, rice, sweet vernal grass, timothy, careless weed, pigweed, common cocklebur, sorrel dock, goldenrod, kochia, lamb's quarters, marigold, nettle, pigwood, English plantain, giant ragweed, short ragweed, western ragweed, Russian thistle, sagebrush, Scotch broom, sheep sorrel, etc.); allergens from insects (silkworms, mites, honeybees, wasps, ants, cockroaches, etc.); allergens from fungi ( Alternaria tenuis, Aspergillus fumigatus, Botrytis cinerea, Candida albicans, Cephalosporium acremonium, Curvularia spicifera, Epicoccum nigrum, Epidermophyton floccosum, Fusarium vasinfectum, Helminthosporium interseminatum, Hormodendrum cladosporioides, Mucor rasemosus, Penicillium notatum, Phoma herbarium, Pullularia pullulans, Rhizopus nigricans , etc.); allergens from fur of animals (dogs, cats, birds, etc.); allergens from house dust; and allergens from foods. The allergen is not particularly limited as long as it is an allergen with which an antibody of a person with allergic disease specifically reacts. [0063] Today, there is a demand for hyposensitization therapy for cedar pollen allergy that afflicts many people. [0064] Therefore, in the pharmaceutical composition of the present invention, the allergen is preferably cedar pollen allergen protein. [0065] Examples of the cedar pollen allergen protein include those containing, as an active ingredient, at least one selected from the group consisting of antigenic proteins extracted from cedar pollen with which an antibody of a person with allergic disease specifically reacts, and proteins having high homology with the above proteins at the amino acid level. [0066] Examples of the protein having antigenicity from the cedar pollen include proteins that are contained in cedar pollen and capable of inducing the production of cedar pollen-specific IgE antibodies. These proteins contained in cedar pollen include major cedar pollen allergen proteins and minor cedar pollen allergen proteins. [0067] In several cedar pollen extracts included in pollen, components to which a majority of patients are highly sensitized are referred to as the major cedar pollen allergen proteins, while components to which only some of the patients are sensitized are referred to as the minor cedar pollen allergen proteins. [0068] The cedar pollen allergen proteins may be in a liquid or solid form containing such proteins. The cedar pollen allergen protein in a liquid form is referred to as a cedar pollen extract. When a liquid cedar pollen extract is used, the pharmaceutical composition of the present invention can be used as-is as an injectable solution or an oral solution. The pharmaceutical composition of the present invention may also be transformed into a gel as an oral solid preparation. [0069] Particularly preferred as the cedar pollen extracts are Cryj1 and Cryj2, which are the major cedar pollen allergen proteins, and a mixture thereof. A cedar pollen extract containing not only Cryj1 and Cryj2 but also minor cedar pollen allergen proteins is also preferably used as-is or in a dilute or lyophilized solid form. [0070] Although the amount of the allergen varies depending on its properties and the like, usually, a preferred amount is 1×10 −10 to 60% by weight based on the total amount of the pharmaceutical composition of the present invention. With less than 1×10 −10 % by weight, the resulting product may not be suitable for hyposensitization therapy. With more than 60% by weight, the strength of a preparation containing the pharmaceutical composition of the present invention may be significantly reduced, causing problems in terms of shape retainability. [0071] Further, the pharmaceutical composition of the present invention is preferably such that the aqueous solution of the allergen-containing preparation immediately before lyophilization in the production process has a pH of 5.0 to 9.0. With a pH in this range, it is possible to prevent a significant reduction in physicochemical stability of the allergen and thereby ensure the safety. A more preferred pH range is 6.0 to 8.0. [0072] The pharmaceutical composition of the present invention preferably includes a pH adjuster in order to adjust the pH of the aqueous solution of the allergen-containing preparation in the above range. [0073] The pH adjuster is not particularly limited. Examples thereof include those proven to be useful as pharmaceutical additives, such as adipic acid, aqueous ammonia, hydrochloric acid, sodium carbonate, dilute hydrochloric acid, citric acid hydrate, glycine, glucono-δ-lactone, gluconic acid, sodium dihydrogen phosphate (crystal), succinic acid, acetic acid, ammonium acetate, sodium acetate hydrate, diisopropanolamine, tartaric acid, potassium hydroxide, calcium hydroxide, sodium hydroxide, magnesium hydroxide, sodium hydrogen carbonate, sodium carbonate hydrate, triisopropanolamine, triethanolamine, carbon dioxide, lactic acid, sodium lactate solution, glacial acetic acid, fumaric acid, monosodium fumarate, sodium propionate, boric acid, ammonium borate, borax, maleic acid, anhydrous citric acid, anhydrous sodium monohydrogen phosphate, anhydrous sodium dihydrogen phosphate, meglumine, methanesulfonic acid, monoethanolamine, sulfuric acid, aluminum potassium sulfate hydrate, DL-malic acid, phosphoric acid, trisodium phosphate, dipotassium phosphate, potassium dihydrogen phosphate, and sodium dihydrogen phosphate. Any of these pH adjusters may be used alone or in combination of two or more thereof. [0074] The pH adjuster may be a combination of an organic acid and a salt, which form an organic acid salt equivalent to those listed above as examples of the pH adjuster used in the pharmaceutical composition. For examples, it may be a combination of an organic acid and a salt such as sodium chloride, calcium chloride, magnesium chloride, or potassium chloride. [0075] From the viewpoint of production, the pH adjuster is preferably one capable of adjusting the pH with a small amount. Examples of such pH adjusters include hydrochloric acid and sodium hydroxide. [0076] Organic acids and organic acid salts effective in inhibiting denaturation and aggregation of proteins are also preferred as the pH adjuster. Examples of such pH adjusters include citric acid hydrate, glycine, glucono-6-lactone, gluconic acid, succinic acid, acetic acid, sodium acetate hydrate, tartaric acid, lactic acid, glacial acetic acid, fumaric acid, monosodium fumarate, sodium propionate, maleic acid, anhydrous citric acid, and malic acid. [0077] The pharmaceutical composition of the present invention may further contain at least one organic acid salt that functions to improve the stability of the allergen. [0078] Examples of such organic acid salts include amino acid salts, adipate, citrate, malate, acetate, succinate, propionate, butyrate, malonate, glutarate, maleate, glycolate, lactate, gluconate, fumarate, tartrate, glycyrrhizinate, and pimelate. These organic acid salts may be used alone or in any combination of two or more thereof. [0079] Particularly preferred among the above organic acid salts are those proven to be useful as pharmaceutical additives and whose pH does not deviate from an optimal pH range (5.0 to 9.0) of the allergen-containing pharmaceutical composition when dissolved in water. Specific examples include calcium lactate, dipotassium glycyrrhizate, disodium glycyrrhizinate, trisodium glycyrrhizinate, sodium citrate, calcium gluconate, sodium gluconate, magnesium gluconate, disodium succinate, DL-sodium tartrate, L-sodium tartrate, and potassium sodium tartrate. These may be used alone or in combination of two or more. [0080] Particularly preferred are calcium lactate, dipotassium glycyrrhizate, and sodium citrate from the viewpoint of the stabilizing effect on the allergen. [0081] In the pharmaceutical composition of the present invention, the amount of the organic acid salt is preferably 0.01 to 20% by weight, more preferably 0.1 to 10% by weight, based on the total weight of the allergen-containing preparation solution immediately before lyophilization in the production process. With less than 0.01% by weight, the resulting product may exhibit hardly any stabilizing effect on the allergen. In contrast, with more than 20% by weight, it may be difficult to control the physical properties of the pharmaceutical composition due to the added additives. Additionally, many organic acid salts have a peculiar taste, and it may cause problems in use, considering the fact that a preparation containing the pharmaceutical composition of the present invention is for oral administration. [0082] The pharmaceutical composition of the present invention may further include an additive that improves the physical properties of the pharmaceutical composition and the stability and solubility of the allergen, for example, at least one selected from the group consisting of sugars, sugar alcohols, and sugar fatty acids, which do not belong to group (B) described above. [0083] Examples of such sugars include monosaccharides, disaccharides, and tri- to hexasaccharides listed below. [0084] Examples of monosaccharides include: aldotetroses such as erythrose and threose; aldopentoses such as ribose, lyxose, xylose, and arabinose; aldohexoses such as allose, talose, gulose, altrose, galactose, and idose; ketotetroses such as erythrulose; ketopentoses such as xylulose and ribulose; and ketohexoses such as psicose, fructose, sorbose, and tagatose. Examples of disaccharides include: α-diglucosides such as kojibiose, nigerose, maltose, and isomaltose; β-diglucosides such as isotrehalose, sophorose, laminaribiose, cellobiose, and gentiobiose; α,β-diglucocides such as neotrehalose; and isomaltulose (palatinose). Examples of tri- to hexasaccharides include cyclic oligosaccharides such as fructooligosaccharides, galactooligosaccharides, xylooligosaccharides, isomaltooligosaccharides, chitin oligosaccharides, chitosan oligosaccharides, oligoglucosamine, and cyclodextrins. [0085] Examples of monosaccharide alcohols include: tetritols such as erythritol, D-threitol, and L-threitol; pentitols such as D-arabinitol and xylitol; hexitols such as D-iditol, galactitol (dulcitol), and mannitol; and cyclitols such as inositol. Examples of disaccharide alcohols include lactitol; and examples of oligosaccharide alcohols include pentaerythritol and reduced malt sugar starch syrup. [0086] A sugar or sugar alcohol substitute may be used in the pharmaceutical composition of the present invention. The sugars and sugar alcohols can be used alone or in combination of two or more thereof. [0087] The sugars or sugar alcohols are preferably mono- to trisaccharides or sugar alcohols thereof from the viewpoint of facilitating the dissolution of the pharmaceutical composition of the present invention in the oral cavity and preventing a significant change in the viscosity of the solution in the production process. [0088] Examples of the sugar fatty acids include sorbitan fatty acid esters and sucrose fatty acid esters. [0089] Examples of the sorbitan fatty acid esters include sorbitan monooleate, sorbitan trioleate, sorbitan sesquioleate, sorbitan cocoate, and polyoxyethylene sorbitan fatty acid esters. [0090] Examples of the sucrose fatty acid esters include sucrose stearate, sucrose oleate, sucrose palmitate, sucrose myristate, sucrose behenate, sucrose erucate, and sucrose-mixed fatty acid esters. [0091] These sugar fatty acids are very convenient because they are useful not only as stabilizers of proteins and peptides but also as defoamers. [0092] In the pharmaceutical composition of the present invention, the amount of the above additives is preferably 1 to 80% by weight, more preferably 5 to 70% by weight, based on the total weight of the pharmaceutical composition of the present invention. With less than 1% by weight, sufficient physical properties for use may not be attained. In contrast, with more than 80% by weight, it may be difficult to control the physical properties of the pharmaceutical composition due to the added additives. [0093] The pharmaceutical composition of the present invention may suitably contain, in addition to the above-described materials, the following additives as desired, as ingredients constituting the base materials: perfumes, flavoring substances, sweetening agents, colorants, antiseptics, antioxidants, other stabilizers, surfactants, and the like. These additives are not particularly limited and any known additive can be used. [0094] The pharmaceutical composition of the present invention is preferably free of water. [0095] Because the pharmaceutical composition of the present invention is free of water, there is no need, for example, for antiseptics or sterilization treatment required for general jelly preparations containing pharmaceutical compositions, and this gives advantage in terms of production costs. The pharmaceutical composition of the present invention is also suitably used in nutritional supplements for patients who require fluid restriction. [0096] The expression “free of water” as used herein includes a case where the pharmaceutical composition is substantially free of water. For example, it means that the water content is 5% by weight or less, preferably 2.5% by weight or less, and more preferably 1% by weight or less, based on the total weight of the pharmaceutical composition of the present invention. [0097] An oral solid preparation can be prepared using the pharmaceutical composition of the present invention. In addition to the above-mentioned materials, any of the following additives may be suitably used as desired: excipients, binders, perfumes, flavoring substances, sweetening agents, colorants, antiseptics, antioxidants, stabilizers, surfactants, and the like. These additives are not particularly limited and any known additive can be used. [0098] Examples of the oral solid preparation include tablets, coated tablets, powders, granules, fine granules, orally disintegrating tablets, oral patches, jellies, and films. The oral solid preparation is not particularly limited as long as it is in a solid form for oral, sublingual, and buccal administration. [0099] Such a pharmaceutical composition of the present invention is suitably used for oral hyposensitization therapy in which the sensitization time must be controlled; and is particularly suitable for sublingual hyposensitization therapy. Because the pharmaceutical composition of the present invention contains specific additives as stabilizers, it can stably maintain allergens, particularly proteins and peptides. [0100] Further, the pharmaceutical composition of the present invention is a porous solid called cake, and is a lyophilized preparation produced by a method in which water used as a solvent in an aqueous solution containing an allergen is sublimated by lyophilization (described later). [0101] The lyophilized preparation as the pharmaceutical composition of the present invention is physically stable from room temperature to about 60° C. [0102] Additionally, because the pharmaceutical composition of the present invention mainly contains the above-described polysaccharide additives, it can be easily dissolved at a temperature close to the body temperature in the oral cavity in an amount of water in the oral cavity, and the physical properties for use can be significantly improved. [0103] The pharmaceutical composition can also stably maintain an allergen protein, particularly cedar pollen allergen protein. [0104] The pharmaceutical composition of the present invention may be directly swallowed, or may be immediately dissolved in the oral cavity and then swallowed. It is also possible to control the dissolution time in the oral cavity to allow absorption through oral or sublingual mucosa. [0105] The pharmaceutical composition of the present invention significantly improves the QOL of patients and caregivers from the following viewpoints: it completely dissolves at about body temperature, thus leaving no sense of residue; and it is physically stable, thus making it easy for patients and caregivers to pick it up with the fingers. [0106] Although the physical strength of the pharmaceutical composition of the present invention is not particularly limited, for example, the pharmaceutical composition preferably has a physical strength to resist physical damage such as cracks and chips when the preparation is packed, stored, transported, or handled by patients. Further, even when the preparation is held with the hands, such contact at about body temperature causes no melting of the preparation or deterioration in properties. [0107] While a preparation containing the pharmaceutical composition of the present invention is physically stable, it also must be quickly broken down in the presence of water, for example, in contact with saliva in the mouth. The preparation is preferably broken down in the oral cavity within 150 seconds, more preferably within 60 seconds. [0108] Although the size of the pharmaceutical composition of the present invention is not particularly limited, the pharmaceutical composition preferably has a planer area of 0.5 to 6.0 cm 2 . With a planar area of less than 0.5 cm 2 , a preparation containing the pharmaceutical composition of the present invention may be difficult to handle when it is picked up with the fingers for administration. With a planer area of more than 6.0 cm 2 , such a preparation may not be completely placed in the oral cavity, particularly under the tongue. [0109] The pharmaceutical composition of the present invention can be prepared, for example, by a method including preparing an allergen-containing preparation solution in which an allergen and additives are dissolved in water, and lyophilizing the allergen-containing preparation solution. [0110] Such a method for producing the pharmaceutical composition of the present invention is also one aspect of the present invention. [0111] The additives described in the method for producing the pharmaceutical composition of the present invention are the same as those in the above-described pharmaceutical composition of the present invention. [0112] The allergen-containing preparation solution prepared in the step of preparing an allergen-containing preparation solution preferably has a pH in the range of 5.0 to 9.0. With a pH of the allergen-containing preparation solution in this range, it is possible to prevent a significant reduction in the physicochemical stability of the allergen and thereby ensure the safety. [0113] In this step, other ingredients such as pH adjusters and additives may be added if necessary. [0114] In the step of lyophilizing the allergen-containing preparation solution, for example, a predetermined amount of the allergen-containing aqueous solution is preferably dispensed at a temperature of 28 to 35° C. into a blister of a desired size for lyophilization, and lyophilized immediately after being dispensed. [0115] The resulting pharmaceutical composition is preferably formed into a finished product by being sealed in a package if necessary. [0116] The pharmaceutical composition of the present invention prepared by the above method is a lyophilized preparation as described above, and is suitable as an oral solid preparation. The pharmaceutical composition after lyophilization has an excellent external appearance and good solubility in water for injection, and can maintain the stability of the allergen for a long period of time. Accordingly, it can also be used as an injectable solution or preparation for transmucosal (transnasal, oral, sublingual) administration. Advantageous Effects of the Invention [0117] Because the pharmaceutical composition of the present invention contains specific additives in addition to an allergen, it has excellent storage stability for preservation and delivery of the allergen. [0118] Additionally, according to the method for producing the pharmaceutical composition of the present invention, even an allergen known to have very poor thermal stability can be stably maintained during production, and the resulting pharmaceutical composition also has excellent storage stability. DESCRIPTION OF EMBODIMENTS [0119] The present invention is specifically described with reference to the following examples, but is not limited to these examples. [0120] Test Example Using Additive of Group (A) (polysaccharides having high formability) Test Example 1 [0121] LM pectin (10 parts by weight, GENU PECTIN Type LM-102AS-J manufactured by CP Kelco) was added and dissolved, by heating if necessary, in purified water (989.9 parts by weight). After the mixture was cooled to room temperature, 0.1 parts by weight of cedar pollen extract lyophilized powder (manufactured by LSL) was added to the mixture, sufficiently mixed, and dissolved at room temperature. The obtained preparation solution was dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a medicament-containing composition. [0122] For a storage stability test, the obtained medicament-containing composition was stored at 40±2° C. for 30 days, and the allergenic activity at day 7, day 14, and day 30 of storage was evaluated by the method described below. Table 2 shows the results. Test Examples 2 to 6 [0123] Preparation solutions were prepared with the compositions shown in Table 1 by the same procedure as in Test Example 1, and lyophilized to prepare medicament-containing compositions. In Test Example 2, HM pectin (GENU PECTIN Type USP-H manufactured by CP Kelco) was used. In Test Example 3, dextran 40 (manufactured by Wako Pure Chemical Industries, Ltd.) was used. In Test Example 4, dextran 70 (manufactured by Wako Pure Chemical Industries, Ltd.) was used. In Test Example 5, starch (manufactured by Wako Pure Chemical Industries, Ltd.) was used. In Test Example 6, pullulan (manufactured by Hayashibara Co., Ltd.) was used. The medicament-containing compositions obtained in Test Examples 2 to 6 were subjected to a storage stability test in the same manner as in Test Example 1. Table 2 shows the results. (Allergenic Activity Evaluation Method) [0124] The allergenic activity of Cry j 1, which is one of the major cedar pollen allergens, was measured using a cedar pollen antigen ELISA Kit “Cry j 1” (manufactured by Seikagaku Biobusiness Corporation). The principle of the measurement kit is a sandwich ELISA that uses monoclonal antibodies (013 and 053) specific to Cry j 1, which is one of Japanese Cedar ( Cryptomeria japonica ) pollen antigens. This kit can specifically measure Cry j 1. [0125] A standard solution or a sample (20 μL) was added to a reaction buffer solution (100 μL) included in the kit, and a primary reaction was carried out at room temperature for 60 minutes. Then, an HRP-labeled antibody solution (100 μL) was added to the reaction product, and a secondary reaction was carried out for 60 minutes. An enzyme substrate solution (100 μL) was added thereto, and a reaction was carried out at room temperature and shielded from light for 30 minutes. Finally, a reaction stop solution (100 μL) was added thereto. Subsequently, the ultraviolet absorption intensity at 450 nm was measured. A calibration curve was determined based on the absorption intensity of the standard solution at various Cry j 1 concentrations, and the Cry j 1 allergenic activity (ng/mL) of each sample was determined based on the calibration curve. [0126] The Cry j 1 allergenic activity % was determined after sampling the pharmaceutical compositions subjected to the storage stability test (at day 7, day 14, and day 30 of storage) and immediately after production (30 minutes and 60 minutes after production). The Cry j 1 allergenic activity % was evaluated based on the following scoring criteria. [0127] 5: 90% or more to less than 105% [0128] 4: 75% or more to less than 90% [0129] 3: 60% or more to less than 75% [0130] 2: 45% or more to less than 60% [0131] 1: 30% or more to less than 45% [0132] 0: less than 30% [0000] TABLE 1 Composition [parts by weight] Test Examples Ingredients 1 2 3 4 5 6 Lyophilized 0.1 0.1 0.1 0.1 0.1 0.1 dry powder of cedar pollen extract LM pectin 10 — — — — — HM pectin — 10 — — — — Dextran 40 — — 10 — — — Dextran 70 — — — 10 — — Starch — — — — 10 — Pullulan — — — — — 10 [Purified water] [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 Composition Group A [0000] TABLE 2 Remaining allergenic activity Sample Day 7 Day 14 Day 30 Test Example 1 Group A 5 5 4 Test Example 2 5 4 4 Test Example 3 4 4 3 Test Example 4 4 4 3 Test Example 5 4 4 3 Test Example 6 4 3 3 [0133] Test Example Using Additive of Group (B) (consisting of sugars, sugar alcohols, maltodextrin, and PVP) Test Example 7 [0134] Glucose (10 parts by weight, manufactured by Wako Pure Chemical Industries, Ltd.) was added and dissolved, by heating if necessary, in purified water (989.9 parts by weight). After the mixture was cooled to room temperature, cedar pollen extract lyophilized powder (0.1 parts by weight, manufactured by LSL) was added to the mixture, sufficiently mixed, and dissolved at room temperature. The obtained preparation solution was dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a medicament-containing composition. [0135] For a storage stability test, the obtained medicament-containing composition was stored at 40±2° C. for 30 days, and the allergenic activity at day 7, day 14, and day 30 of storage was evaluated by the same method as in Test Example 1. Table 4 shows the results. Test Examples 8 to 17 [0136] Preparation solutions were prepared with the compositions shown in Table 3 by the same procedure as in Test Example 7, and lyophilized to prepare medicament-containing compositions. In Test Example 8, mannose (manufactured by Wako Pure Chemical Industries, Ltd.) was used. In Test Example 9, trehalose (manufactured by Hayashibara Co., Ltd.) was used. In Test Example 10, raffinose (manufactured by Wako Pure Chemical Industries, Ltd.) was used. In Test Example 11, maltitol (manufactured by Hayashibara Biochemical Laboratories, Inc.) was used. In Test Example 12, isomalt (Galen 800 manufactured by BENEO-Palatinit GmbH) was used. In Test Example 13, sorbitol (manufactured by Roquette) was used. In Test Example 14, maltodextrin (AMICOL 10 manufactured by Nippon Starch Chemical Co., Ltd.) was used. In Test Example 15, PVP K25 (manufactured by Wako Pure Chemical Industries, Ltd.) was used. In Test Example 16, PVP K30 (manufactured by Wako Pure Chemical Industries, Ltd.) was used. In Test Example 17, PVP K90 (Wako Pure Chemical Industries, Ltd.) was used. The medicament-containing compositions obtained in Test Examples 8 to 17 were subjected to a storage stability test in the same manner as in Test Example 1. Table 4 shows the results. Comparative Test Example 1 [0137] Cedar pollen extract lyophilized powder (0.1 parts by weight, manufactured by LSL) was added to purified water (999.9 parts by weight), and dissolved at room temperature. Subsequently, the resultant mixture was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a medicament-containing composition. The obtained medicament-containing composition was stored at 40±2° C., and the allergenic activity at day 7, day 14, and day 30 of storage was evaluated by the same method as in Test Example 1. Table 4 shows the results. [0138] Test Examples Using Group (B′) (additives that are sugars but have no stabilizing effect on cedar pollen allergens) Comparative Test Examples 2 to 6 [0139] Preparation solutions were prepared with the compositions shown in Table 3 by the same procedure as in Test Example 7, and lyophilized to prepare medicament-containing compositions. In Comparative Test Example 2, mannitol (manufactured by Roquette) was used. In Comparative Test Example 3, erythritol (Wako Pure Chemical Industries, Ltd.) was used. In Comparative Test Example 4, xylitol (manufactured by Wako Pure Chemical Industries, Ltd.) was used. In Comparative Test Example 5, polyethyleneglycol 4000 (PEG4000 manufactured by Wako Pure Chemical Industries, Ltd.) was used. In Comparative Test Example 6, polyethyleneglycol 20000 (PEG20000 manufactured by Wako Pure Chemical Industries, Ltd.) was used. PEG was used as an example to be tested in comparison to PVP, which is also a water-soluble polymer. The medicament-containing compositions obtained in Comparative Test Examples 2 to 6 were subjected to a storage stability test in the same manner as in Test Example 1. Table 4 shows the results. [0000] TABLE 3 Composition [parts by weight] Test Examples Ingredients 7 8 9 10 11 12 13 14 15 Lyophilized dry 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 powder of cedar pollen extract Glucose 10 — — — — — — — — Mannose — 10 — — — — — — — Trehalose — — 10 — — — — — — Raffinose — — — 10 — — — — — Maltitol — — — — 10 — — — — Isomalt — — — — — 10 — — — Sorbitol — — — — — — 10 — — Maltodextrin — — — — — — — 10 — PVP K25 — — — — — — — — 10 PVP K30 — — — — — — — — — PVP K90 — — — — — — — — — Mannitol — — — — — — — — — Erythritol — — — — — — — — — Xylitol — — — — — — — — — PEG4000 — — — — — — — — — PEG20000 — — — — — — — — — [Purified water] [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Group B Composition [parts by weight] Test Examples Comparative Test Examples Ingredients 16 17 1 2 3 4 5 6 Lyophilized dry 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 powder of cedar pollen extract Glucose — — — — — — — — Mannose — — — — — — — — Trehalose — — — — — — — — Raffinose — — — — — — — — Maltitol — — — — — — — — Isomalt — — — — — — — — Sorbitol — — — — — — — — Maltodextrin — — — — — — — — PVP K25 — — — — — — — — PVP K30 10 — — — — — — — PVP K90 — 10 — — — — — — Mannitol — — — 10 — — — — Erythritol — — — — 10 — — — Xylitol — — — — — 10 — — PEG4000 — — — — — — 10 — PEG20000 — — — — — — — 10 [Purified water] [989.9] [989.9] [999.9] [989.9] [989.9] [989.9] [989.9] [989.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Group B — Group [B′] [0000] TABLE 4 Remaining allergenic activity Sample Day 7 Day 14 Day 30 Test Example 7 Group B 5 4 4 Test Example 8 5 4 3 Test Example 9 5 4 4 Test Example 10 5 5 4 Test Example 11 5 4 4 Test Example 12 5 4 3 Test Example 13 4 4 3 Test Example 14 4 4 4 Test Example 15 5 4 4 Test Example 16 5 4 4 Test Example 17 5 4 4 Comparative Test Example 1 — 2 1 0 Comparative Test Example 2 Group [B′] 2 1 0 Comparative Test Example 3 2 1 0 Comparative Test Example 4 0 0 0 Comparative Test Example 5 3 1 0 Comparative Test Example 6 3 0 0 [0140] As shown in Table 4, the sugars and sugar alcohols shown in Test Examples 7 to 17 were found to act as allergen stabilizers during lyophilization. On the other hand, the results show that the medicament-containing compositions of Comparative Test Examples in which mannitol and the like reportedly capable of stabilizing other allergens and vaccines were used were not necessarily effective against cedar pollen allergens. In regard to the water-soluble synthetic polymers, PVP was found to show a high stabilizing effect on the allergen. [0141] Test Example Using Additive of Group (C) (viscous polysaccharides) Test Example 18 [0142] Guar gum (10 parts by weight, MEYRO-GUAR CSA200/50, manufactured by DANISCO) was added and dissolved, by heating if necessary, in purified water (989.9 parts by weight). After the mixture was cooled to room temperature, cedar pollen extract lyophilized powder (0.1 parts by weight, manufactured by LSL) was added to the mixture, sufficiently mixed, and dissolved at room temperature. The obtained preparation solution was dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a medicament-containing composition. [0143] For a storage stability test, the medicament-containing composition was stored at 40±2° C. for 30 days, and the allergenic activity at day 7, day 14, and day 30 of storage was evaluated by the same method as in Test Example 1. Table 6 shows the results. Test Examples 19 to 24 [0144] Preparation solutions were prepared with the compositions shown in Table 5 by the same procedure as in Test Example 18, and lyophilized to prepare medicament-containing compositions. In Test Example 19, locust bean gum (GENUGUM RL-200-J manufactured by CP Kelco) was used. In Test Example 20, xanthan gum (Echo-gum T manufactured by DSP Gokyo Food & Chemical Co., Ltd.) was used. In Test Example 21, tamarind gum (Glyloid 3S manufactured by DSP GOKYO FOOD & CHEMICAL CO., LTD.) was used. In Test Example 22, tara gum (MT120 manufactured by MRC Polysaccharide Co., Ltd.) was used. In Test Example 23, ι-carrageenan (CP Gum FA manufactured by DSP GOKYO FOOD & CHEMICAL CO., LTD.) was used. In Test Example 24, deacylated gellan gum (Kelcogel manufactured by CP Kelco) was used. The medicament-containing compositions obtained in Test Examples 19 to 24 were subjected to a storage stability test in the same manner as in Test Example 1. Table 6 shows the results. [0145] Test Examples Using Group (C′) (additives that are viscous polysaccharides but have no stabilizing effect on the cedar pollen allergen) Comparative Test Examples 7 and 8 [0146] Preparation solutions were prepared with the compositions shown in Table 5 by the same procedure as in Test Example 18, and lyophilized to prepare medicament-containing compositions. In Comparative Test Example 7, sodium alginate (Kimica Algin IL-6 manufactured by KIMICA corporation) was used. In Comparative Test Example 8, κ-carrageenan (GENUGEL JPE-126 manufactured by CP Kelco) was used. The medicament-containing compositions obtained in Comparative Test Examples 7 and 8 were subjected to a storage stability test in the same manner as in Test Example 1. Table 6 shows the results. [0000] TABLE 5 Composition [parts by weight] Comparative Test Examples Test Examples Ingredients 18 19 20 21 22 23 24 7 8 Lyophilized dry 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 powder of cedar pollen extract Guar gum 10 — — — — — — — — Locust bean gum — 10 — — — — — — — Xanthan gum — — 10 — — — — — — Tamarind gum — — — 10 — — — — — Tara gum — — — — 10 — — — — l-Carrageenan — — — — — 10 — — — Deacylated gellan — — — — — — 10 — — gum Alginate Na — — — — — — — 10 — k-Carrageenan — — — — — — — — 10 [Purified water] [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Group C Group [C′] [0000] TABLE 6 Remaining allergenic activity Sample Day 7 Day 14 Day 30 Test Example 18 Group C 5 5 4 Test Example 19 5 5 4 Test Example 20 5 4 4 Test Example 21 5 4 4 Test Example 22 4 4 4 Test Example 23 4 4 3 Test Example 24 4 3 3 Comparative Test Example 7 Group [C′] 3 2 1 Comparative Test Example 8 3 0 0 [0147] As shown in Table 6, the gelling agents used in Test Examples 18 to 24 were found to act as allergen stabilizers during lyophilization. Among these gelling agents, guar gum, locust bean gum, xanthan gum, tamarind gum, and tara gum were found to show a high stabilizing effect on the allergen. [0148] Group (A)+Group (B) (polysaccharides having formability+sugars, maltodextrin, PVP, Etc.) Example 1 [0149] LM pectin (30 parts by weight) and glucose (10 parts by weight) were added to purified water (850 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0150] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was stored at 40±2° C. for 90 days, and the allergenic activity after storage was evaluated by the same method as in Test Example 1. The pharmaceutical composition was also evaluated for its properties and solubility in water by the methods described below. Table 9 shows the results expressed as scores. (Evaluation of Properties) [0151] The obtained pharmaceutical composition was evaluated based on the following criteria. Thereafter, it was stored at 40±2° C. for 3 months, and evaluated again after storage. Table 9 shows the results. [0152] 3: There are no problems in use [0153] 1: There are problems in use (Evaluation of Solubility in Water) [0154] Purified water (10.0 g) heated to 37° C. was added to the obtained pharmaceutical composition (1.0 g), and the dissolution of the pharmaceutical composition was observed at room temperature and evaluated based on the following criteria. Table 9 shows the results. [0155] 3: Completely dissolved within 60 seconds. [0156] 2: Completely dissolved in about 1 to 5 minutes. [0157] 1: It took 5 minutes or more until complete dissolution. Examples 2 to 10 [0158] Allergen-containing preparation solutions were prepared with the compositions shown in Table 7 by the same procedure as in Example 1, and lyophilized to prepare pharmaceutical compositions. The pharmaceutical compositions obtained in Examples 2 to 10 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 9 shows the results. Example 11 [0159] Dextran 40 (60 parts by weight) and raffinose (10 parts by weight) were added to purified water (800 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0160] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 9 shows the results. Examples 12 to 18 [0161] Solutions were prepared with the compositions shown in Table 7 by the same procedure as in Example 11, and lyophilized to prepare pharmaceutical compositions. The pharmaceutical compositions obtained in Examples 12 to 18 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 9 shows the results. [0000] TABLE 7 Composition [parts by weight] Examples Ingredients 1 2 3 4 5 6 7 8 9 Lyophilized dry 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 powder of cedar pollen extract LM pectin 30 30 30 30 30 30 30 30 — HM pectin — — — — — — — — 30 Dextran 40 — — — — — — — — — Dextran 70 — — — — — — — — — Starch — — — — — — — — — Pullulan — — — — — — — — — Glucose 10 — — — — — — — — Raffinose — 10 — — — — — — 10 Trehalose — — 10 — — — — — — Maltitol — — — 10 — — — — — Isomalt — — — — 10 — — — — Sorbitol — — — — — 10 — — — Maltodextrin — — — — — — 10 — — PVP K25 — — — — — — — 10 — Purified water [959.9] [959.9] [959.9] [959.9] [959.9] [959.9] [959.9] [959.9] [959.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Groups A + B Composition [parts by weight] Examples Ingredients 10 11 12 13 14 15 16 17 18 Lyophilized dry 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 powder of cedar pollen extract LM pectin — — — — — — — — — HM pectin 30 — — — — — — — — Dextran 40 — 60 60 — — — — — — Dextran 70 — — — 60 60 — — — — Starch — — — — — 60 60 — — Pullulan — — — — — — — 90 90 Glucose — — — — — — — — — Raffinose — 10 — 10 — 10 — 10 — Trehalose — — — — — — — — — Maltitol — — — — — — — — — Isomalt — — — — — — — — — Sorbitol — — — — — — — — — Maltodextrin — — — — — — — — — PVP K25 10 — 10 — 10 — 10 — 10 Purified water [959.9] [929.9] [929.9] [929.9] [929.9] [929.9] [929.9] [889.9] [889.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Groups A + B [0162] At Least One Additive from Groups (A) and (B), or Group (A)+Group (B′) (polysaccharides having formability+additives that are sugars but have no stabilizing effect) Comparative Example 1 [0163] LM pectin (30 parts by weight) was added to purified water (850 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0164] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 9 shows the results. Comparative Examples 2 to 10 [0165] Solutions were prepared with the compositions shown in Table 8 by the same procedure as in Comparative Example 1, and lyophilized to prepare pharmaceutical compositions. The pharmaceutical compositions obtained in Comparative Examples 2 to 10 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 9 shows the results. Comparative Example 11 [0166] LM pectin (30 parts by weight) and mannitol (10 parts by weight) were added to purified water (850 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0167] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 9 shows the results. Comparative Examples 12 to 14 [0168] Solutions were prepared with the compositions shown in Table 8 by the same procedure as in Comparative Example 11, and lyophilized to prepare a pharmaceutical composition. The pharmaceutical compositions obtained in Comparative Examples 12 to 14 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 9 shows the results. [0000] TABLE 8 Composition [parts by weight] Comparative Examples Ingredients 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Lyophilized 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 dry powder of cedar pollen extract LM pectin 30 — — — — — — — — — 30 — — — HM pectin — 30 — — — — — — — — — — — — Dextran 40 — — 60 — — — — — — — — 60 — — Dextran 70 — — — 60 — — — — — — — — — — Starch — — — — 60 — — — — — — — 60 — Pullulan — — — — — 90 — — — — — — — 90 Glucose — — — — — — 30 — — — — — — — Raffinose — — — — — — — — — — — — — — Trehalose — — — — — — — — — — — — — — Maltitol — — — — — — — — — — — — — — Isomalt — — — — — — — — — — — — — — Sorbitol — — — — — — — — — — — — — — Maltodextrin — — — — — — — 30 — — — — — — Dextran 70 — — — — — — — — 30 — — — — — PVP K25 — — — — — — — — — 30 — — — — Mannitol — — — — — — — — — — 10 10 10 10 Purified water [969.9] [969.9] [939.9] [939.9] [939.9] [909.9] [969.9] [969.9] [969.9] [969.9] [959.9] [929.9] [929.9] [899.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Group A Group B Groups A + [B′] [0000] TABLE 9 Remaining allergenic activity Properties Solubility Sample Day 14 Day 30 Day 90 Day 0 Day 90 Water [37° C.] Total Example 1 Groups 5 5 4 3 3 3 23 Example 2 A + B 5 5 4 3 3 3 23 Example 3 5 5 4 3 3 3 23 Example 4 5 5 4 3 3 3 23 Example 5 5 5 4 3 3 3 23 Example 6 5 4 4 3 3 3 22 Example 7 5 5 4 3 3 3 23 Example 8 5 5 4 3 3 3 23 Example 9 5 5 4 3 3 3 23 Example 10 5 5 4 3 3 3 23 Example 11 5 5 4 3 3 3 23 Example 12 5 5 4 3 3 3 23 Example 13 5 5 4 3 3 3 23 Example 14 5 5 4 3 3 3 23 Example 15 5 4 4 3 3 3 22 Example 16 5 4 4 3 3 3 22 Example 17 5 4 4 3 3 3 22 Example 18 5 4 4 3 3 3 22 Comparative Example 1 Group A 5 4 3 3 1 3 19 Comparative Example 2 5 4 3 3 1 3 19 Comparative Example 3 4 4 3 3 1 3 18 Comparative Example 4 4 4 3 3 1 3 18 Comparative Example 5 4 3 2 3 1 3 16 Comparative Example 6 4 3 2 3 1 3 16 Comparative Example 7 Group B 4 4 2 1 1 3 15 Comparative Example 8 4 3 2 1 1 3 14 Comparative Example 9 4 3 2 3 1 3 16 Comparative Example 10 4 4 3 3 1 3 18 Comparative Example 11 Group 4 3 2 3 3 3 18 Comparative Example 12 A + [B′] 3 3 2 3 3 3 17 Comparative Example 13 3 2 2 3 3 3 16 Comparative Example 14 3 2 1 3 3 3 15 [0169] As shown in Table 9, the pharmaceutical compositions of Comparative Examples 1 to 10 consisting of only one additive from group (A) or group (B) showed poor stability of the allergen and deteriorated properties at day 90 of storage, which would cause problems in use. However, the pharmaceutical compositions of Examples showed improvement in the stability of the allergen and the stability of the properties by the combined use of additives from group (A) and group (B). [0170] Group (B)+Group (C) (sugars, maltodextrin, PVP+viscous polysaccharides) Example 19 [0171] Raffinose (50 parts by weight) and guar gum (5 parts by weight) were added to purified water (850 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0172] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was stored at 40±2° C. for 90 days, and the allergenic activity and the properties after storage were evaluated by the same method as in Example 1. The solubility in water was also evaluated by the same method as in Example 1. Table 12 shows the results expressed as scores. Examples 20 to 28 [0173] Allergen-containing preparation solutions were prepared with the compositions shown in Table 10 by the same procedure as in Example 19, and lyophilized to prepare pharmaceutical compositions. The pharmaceutical compositions obtained in Examples 20 to 28 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 12 shows the results. [0000] TABLE 10 Composition [parts by weight] Examples Ingredients 19 20 21 22 23 24 25 26 27 28 Lyophilized dry 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 powder of cedar pollen extract Raffinose 50 50 50 50 50 50 — — — — Maltodextrin — — — — — — 50 50 — — PVP K25 — — — — — — — — 50 50 Guar gum 5 — — — — — 5 — 5 — Locust bean gum — 5 — — — — — 5 — 5 Xanthan gum — — 5 — — — — — — — Tamarind gum — — — 5 — — — — — — l-Carrageenan — — — — 5 — — — — — Deacylated gellan — — — — — 5 — — — — gum Purified water [944.9] [944.9] [944.9] [944.9] [944.9] [944.9] [944.9] [944.9] [944.9] [944.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Groups B + C [0174] At Least One Additive from Group (C), or Group (B)+Group (C′) (sugars, polysaccharides, PVP+additives that are viscous polysaccharides but have no stabilizing effect) Comparative Example 15 [0175] Guar gum (10 parts by weight) was added to purified water (850 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0176] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 12 shows the results. Comparative Examples 16 to 20 [0177] Solutions were prepared with the compositions shown in Table 11 by the same procedure as in Comparative Example 15, and lyophilized to prepare pharmaceutical compositions. The pharmaceutical compositions obtained in Comparative Examples 16 to 20 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 12 shows the results. Comparative Example 21 [0178] Raffinose (50 parts by weight) and κ-carrageenan (5 parts by weight) were added to purified water (850 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0179] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was stored at 40±2° C. for 90 days, and the allergenic activity and the properties after storage were evaluated by the same method as in Example 1. The solubility in water was also evaluated by the same method as in Example 1. Table 12 shows the results expressed as scores. Comparative Examples 22 and 23 [0180] Solutions were prepared with the compositions shown in Table 11 by the same procedure as in Comparative Example 21, and lyophilized to prepare pharmaceutical compositions. The pharmaceutical compositions obtained in Comparative Examples 22 and 23 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 12 shows the results. [0000] TABLE 11 Composition [parts by weight] Comparative Examples Ingredients 15 16 17 18 19 20 21 22 23 Lyophilized dry 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 powder of cedar pollen extract Raffinose — — — — — — 50 — — Maltodextrin — — — — — — — 50 — PVP K25 — — — — — — — — 50 Guar gum 10 — — — — — — — — Locust bean gum — 10 — — — — — — — Xanthan gum — — 10 — — — — — — Tamarind gum — — — 10 — — — — — l-Carrageenan — — — — 10 — — — — Deacylated — — — — — 10 — — — gellan gum k-Carrageenan — — — — — — 5 5 5 Purified water [989.9] [989.9] [989.9] [989.9] [989.9] [989.9] [944.9] [944.9] [944.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Group C Groups B + [C′] [0000] TABLE 12 Remaining allergenic activity Properties Solubility Sample Day 14 Day 30 Day 90 Day 0 Day 90 Water [37° C.] Total Example 19 Groups 5 5 4 3 3 3 23 Example 20 B + C 5 5 4 3 3 3 23 Example 21 5 5 4 3 3 3 23 Example 22 5 5 4 3 3 2 22 Example 23 5 4 4 3 3 2 21 Example 24 5 4 4 3 3 2 21 Example 25 5 5 4 3 3 3 23 Example 26 5 5 4 3 3 3 23 Example 27 5 5 4 3 3 3 23 Example 28 5 5 4 3 3 3 23 Comparative Example 15 Group C 5 4 3 1 1 1 15 Comparative Example 16 5 4 3 1 1 1 15 Comparative Example 17 4 4 3 1 1 1 14 Comparative Example 18 4 4 3 3 1 2 17 Comparative Example 19 4 3 2 1 1 1 12 Comparative Example 20 3 3 1 1 1 1 10 Comparative Example 21 Groups 4 3 2 3 1 2 15 Comparative Example 22 B + [C′] 3 2 1 3 1 2 12 Comparative Example 23 3 3 2 3 1 2 14 [0181] As shown in Table 12, the pharmaceutical compositions of Comparative Examples 15 to 20 consisting of only one additive from group (C) showed slightly higher stability of the allergen than the pharmaceutical compositions shown in Table 9, which consist of other additives. However, many of these pharmaceutical compositions have poor properties, problems in use, and an unsatisfactory solubility in water. [0182] On the other hand, the pharmaceutical compositions of Examples showed that the use of an additive from group (B) having high solubility in water in combination with an additive from group (C) improved the stability of the allergen, the stability of properties, and the solubility in water, thus allowing easy sensitization to the antigen in the oral cavity. [0183] Group (A)+Group (C) (polysaccharides having high formability+viscous polysaccharides) Example 29 [0184] LM pectin (30 parts by weight) and guar gum (5 parts by weight) were added to purified water (850 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0185] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was stored at 40±2° C. for 90 days, and the allergenic activity and the properties after storage were evaluated by the same method as in Example 1. The solubility in water was also evaluated by the same method as in Example 1. Table 15 shows the results expressed as scores. Examples 30 to 42 [0186] Solutions were prepared with the compositions shown in Table 13 by the same procedure as in Example 29, and lyophilized to prepare pharmaceutical compositions. The pharmaceutical compositions obtained in Examples 30 to 42 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 15 shows the results. [0187] Group (A)+Group (C′) (polysaccharides having high formability+additives that are viscous polysaccharides but have no stabilizing effect) Comparative Example 24 [0188] LM pectin (30 parts by weight) and κ-carrageenan (5 parts by weight) were added to purified water (850 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0189] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was stored at 40±2° C. for 90 days, and the allergenic activity and the properties after storage were evaluated by the same method as in Example 1. The solubility in water was also evaluated by the same method as in Example 1. Table 15 shows the results expressed as scores. Comparative Examples 25 to 29 [0190] Solutions were prepared with the compositions shown in Table 14 by the same procedure as in Comparative Example 24, and lyophilized to prepare pharmaceutical compositions. The pharmaceutical compositions obtained in Comparative Examples 25 to 29 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 15 shows the results. [0000] TABLE 13 Composition [parts by weight] Examples Ingredients 29 30 31 32 33 34 35 36 37 38 39 40 41 42 Lyophilized 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 dry powder of cedar pollen extract LM pectin 30 30 30 30 — — — — — — — — — — HM pectin — — — — 30 30 — — — — — — — — Dextran 40 — — — — — — 60 60 — — — — — — Dextran 70 — — — — — — — — 60 60 — — — — Starch — — — — — — — — — — 60 60 — — Pullulan — — — — — — — — — — — — 90 90 Guar gum 5 — — — 5 — 5 — 5 — 5 — 5 — Locust bean — 5 — — — 5 — 5 — 5 — — — — gum Xanthan gum — — 5 — — — — — — — — — — — Tamarind gum — — — 5 — — — — — — — 5 — 5 k-Carrageenan — — — — — — — — — — — — — — Purified water [964.9] [964.9] [964.9] [964.9] [964.9] [964.9] [964.9] [964.9] [964.9] [964.9] [934.9] [934.9] [904.9] [904.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Groups A + C [0000] TABLE 14 Composition [parts by weight] Comparative Examples Ingredients 24 25 26 27 28 29 Lyophilized 0.1 0.1 0.1 0.1 0.1 0.1 dry powder of cedar pollen extract LM pectin 30 — — — — — HM pectin — 30 — — — — Dextran 40 — — 60 — — — Dextran 70 — — — 60 — — Starch — — — — 60 — Pullulan — — — — — 90 Guar gum — — — — — — Locust bean — — — — — — gum Xanthan gum — — — — — — Tamarind gum — — — — — — k-Carrageenan 5 5 5 5 5 5 Purified water [964.9] [964.9] [934.9] [934.9] [934.9] [904.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 Composition Groups A + [C′] [0000] TABLE 15 Remaining allergenic activity Properties Solubility Sample Day 14 Day 30 Day 90 Day 0 Day 90 Water [37° C.] Total Example 29 Groups 5 5 5 3 3 3 24 Example 30 A + C 5 5 5 3 3 3 24 Example 31 5 5 4 3 3 3 23 Example 32 5 5 4 3 3 3 23 Example 33 5 5 5 3 3 3 24 Example 34 5 5 5 3 3 3 24 Example 35 5 5 4 3 3 3 23 Example 36 5 5 4 3 3 3 23 Example 37 5 5 4 3 3 3 23 Example 38 5 5 4 3 3 3 23 Example 39 5 5 4 3 3 3 23 Example 40 5 5 4 3 3 3 23 Example 41 5 5 4 3 3 3 23 Example 42 5 5 4 3 3 3 23 Comparative Example 24 Groups 4 3 2 3 1 2 15 Comparative Example 25 A + [C′] 4 3 2 3 1 2 15 Comparative Example 26 3 3 2 3 1 2 14 Comparative Example 27 3 3 2 3 1 2 14 Comparative Example 28 3 2 1 3 1 2 12 Comparative Example 29 3 2 1 3 1 2 12 [0191] As shown in Table 15, the pharmaceutical compositions of Examples showed that the combined use of an additive from group (C) and an additive from group (A) improved the stability of the allergen, the stability of properties, and the solubility in water, thus allowing easy sensitization to the antigen in the oral cavity. In particular, the use of pectin and guar gum or locust bean gum (both are galactomannans) was found to show high stability of the allergen. [0192] Group (A)+Group (B)+Group (C) Example 43 [0193] LM pectin (30 parts by weight), raffinose (10 parts by weight), and guar gum (5 parts by weight) were added to purified water (850 parts by weight), and dissolved therein at a temperature of 40 to 80° C. After dissolution, the mixture was cooled to room temperature. Separately, cedar pollen extract lyophilized powder (10 parts by weight, manufactured by LSL) was added to purified water (30 parts by weight), and dissolved therein at room temperature. Subsequently, an allergen aqueous solution (4 parts by weight) was added to the above-obtained solution (in such a manner that the amount of the cedar pollen extract lyophilized powder in the solution would be 0.1 parts by weight) and quickly mixed, and it was made sure that there was no re-gelation. Using a pH adjuster (sodium hydroxide), the pH was adjusted to 6.5. Further, purified water was added to the mixture to adjust the total weight to 1000 parts by weight, thereby obtaining an allergen-containing preparation solution. [0194] Subsequently, the obtained preparation solution was quickly dispensed in 1.0 g aliquots into a vial for lyophilization, and lyophilized to prepare a pharmaceutical composition. The obtained pharmaceutical composition was stored at 40±2° C. for 90 days, and the allergenic activity and the properties after storage were evaluated by the same method as in Example 1. The solubility in water was also evaluated by the same method as in Example 1. Table 17 shows the results expressed as scores. Examples 44 to 56 [0195] Solutions were prepared with the compositions shown in Table 16 by the same procedure as in Example 44, and lyophilized to prepare pharmaceutical compositions. The pharmaceutical compositions obtained in Examples 44 to 56 were evaluated in the same manner as in Example 1, and the results were expressed as scores. Table 17 shows the results. [0000] TABLE 16 Composition [parts by weight] Examples Ingredients 43 44 45 46 47 48 49 50 51 52 53 54 55 56 Lyophilized 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 dry powder of cedar pollen extract LM pectin 30 30 30 30 — — — — — — — — — — HM pectin — — — — 30 30 — — — — — — — — Dextran 40 — — — — — — 60 60 — — — — — — Dextran 70 — — — — — — — — 60 60 — — — — Starch — — — — — — — — — — 60 60 — — Pullulan — — — — — — — — — — — — 90 90 Raffinose 10 — — — 10 — 10 — 10 — 10 — 10 — Maltodextrin — 10 — — — 10 — — — — — — — — Dextran 70 — — 10 — — — — — — — — — — — PVP K25 — — — 10 — — — 10 — 10 — 10 — 10 Guar gum 5 5 — — 5 — 5 — 5 — 5 — 5 — Locust bean — — 5 5 — 5 — 5 — 5 — 5 — 5 gum Purified water [954.9] [954.9] [954.9] [954.9] [954.9] [954.9] [924.9] [924.9] [924.9] [924.9] [924.9] [924.9] [894.9] [894.9] Aliquot [g/vial] 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Composition Groups A + B + C [0000] TABLE 17 Remaining allergenic activity Properties Solubility Sample Day 14 Day 30 Day 90 Day 0 Day 90 Water [37° C.] Total Example 43 Groups 5 5 5 3 3 3 24 Example 44 A + B + C 5 5 5 3 3 3 24 Example 45 5 5 5 3 3 3 24 Example 46 5 5 5 3 3 3 24 Example 47 5 5 5 3 3 3 24 Example 48 5 5 5 3 3 3 24 Example 49 5 5 5 3 3 3 24 Example 50 5 5 5 3 3 3 24 Example 51 5 5 5 3 3 3 24 Example 52 5 5 5 3 3 3 24 Example 53 5 5 5 3 3 3 24 Example 54 5 5 5 3 3 3 24 Example 55 5 5 5 3 3 3 24 Example 56 5 5 5 3 3 3 24 [0196] As shown in Table 17, the combined use of all additives from group (A), group (B), and group (C) improved the stability of the allergen, the stability of properties, and the solubility in water, and allowed easy sensitization to the antigen in the oral cavity. INDUSTRIAL APPLICABILITY [0197] The pharmaceutical composition of the present invention contains specific non-gelatin additives in combination with an allergen, and thus has excellent storage stability for preservation and delivery of the allergen. [0198] Additionally, according to the method for producing the pharmaceutical composition of the present invention, even an allergen known to have very poor thermal stability can be stably maintained during production, and the resulting pharmaceutical composition also has excellent storage stability.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to the technical field of surgical instruments. 2. Description of the Prior Art In some surgical interventions, the use of trocars is known in order to allow the insertion of various types of endoscopy instruments, in particular into cavities in the human body. This applies, for instance, to pneumoperitonium where it is necessary to inflate the abdomen in order to allow the passage of instruments. The trocar is shaped in order to permit the injection of CO 2 in order to decompress the internal organs. As is completely familiar to those skilled in the art, a trocar essentially comprises a hollow body of which the end has a tip fitted with an internal channel to allow the insertion of the instrument in question. This internal channel communicates with the hollow body. In order to ensure leaktightness when the instrument is withdrawn in order to prevent any loss of previously injected CO 2 , the trocar has internal features capable of fulfilling this function. Regardless of the ways in which trocars are designed, they are generally shaped to only allow the insertion of instruments having a clearly defined diameter. If it is necessary to change instruments during an operation and if the diameter of the instrument is greater or less than that of the trocar the surgeon is often confronted with real problems. In order to attempt to overcome these drawbacks, trocars fitted with interchangeabe tips slide valves or swiveling discs have been proposed in order to match the various diameters of surgical instruments likely to be used. One might mention, for example, the teachings of patent WO-A-92444. However, these solutions are unsatisfactory because they require the surgeon to carry out relatively awkward manipulations involving the use of both hands. In addition, these trocars do not always meet the requirement for leaktightness and are often very bulky. Finally, they are either disposable or resterilizable and necessitate complex disassembly and cleaning procedures. SUMMARY OF THE INVENTION The object of the invention is to overcome these drawbacks in a simple, safe, effective and rational manner. The problems that the invention intends to solve are as follows: Make it possible to modify the diameter of the inlet channel of the trocar tip, in order to adapt it to the diameter of the desired instrument in a compact, ergonomic apparatus with a reducing adapter and a valve seal built into the tip that can be operated externally using one hand with the other hand being able to continue holding the apparatus normally. Make it possible to extract delicate or larger "objects" (needles, stones, etc.) during an intervention through the same trocar. Make it possible to easily disassemble the tip of the trocar, the part that includes all the seals and mechanisms that are difficult to clean. In order to solve such problems a semi-disposable two-piece trocar has been devised and developed of a type having a first cleanable, resterilizable part in the form of a hollow body and a second part formed by a tip equipped with means of sealing in the form of a shutter with a 45° valve mounted so that it swivels and accommodated in the tip of the trocar. The tip is designed using a disposable material, if required, and includes all the seals and mechanisms that are difficult to clean. The two parts of the trocar are assembled by clicking them together or by any other process suitable for such a design. The tip is equipped with features that are completely enclosed, can be operated externally and capable of modifying, at any time during an intervention, the diameter of the channel in order to match it to the diameter of the instrument to be inserted by simply exerting finger pressure. In order to solve the problem of adapting the trocar to the diameter of the instrument to be used, the internal features consist of reducing adapter actuated by a lever in order to coaxially align holes of different diameters with part of the channel into which the instrument is inserted. In a first embodiment, the reducing adapter consists of a hinged arm having at least one hole of diameter smaller than that of the channel and capable of being coaxially aligned with said channel under the action of the lever. In order to solve the problem of ensuring leaktightness after inserting the instrument in order to prevent any leak of CO 2 , the arm is accommodated transversely in a housing formed in the thickness of the tip upstream from a seal of the inlet of the channel in the tip through which the instrument is inserted. The hole or holes of the arm have a sealing device that cooperates with the body of the corresponding instrument. In another embodiment, the reducing adapter consists of a spherical plug having at least two through-holes of different diameter capable of being coaxially aligned with the channel under the action of the lever. The two holes communicate with each other and are arranged in two orthogonal planes. Each hole has a sealing device that cooperates with the body of the corresponding instrument Another problem that the invention aims to solve is to ensure self-penetration of the trocar and its retention in the opposite direction with a view to positioning the trocar correctly. Such a problem is solved in that the body has, over all or part of its length, external annular peripheral ribs. BRIEF DESCRIPTION OF THE DRAWING The invention is explained below in more detail reference being made to the accompanying drawings in which: FIG. 1 is a longitudinal sectional view of a first embodiment of the trocar. FIG. 2 is a transverse sectional view along, line 2--2 in FIG. 1. FIG. 3 is a view that corresponds to FIG. 1 showing how to change the diameter of the inlet channel. FIG. 4 is a transverse sectional view along line 4--4 in FIG. 3. FIG. 5 is a longitudinal sectional view of another embodiment of the trocar before an instrument is inserted. FIG. 6 is a transverse sectional view along line 6--6 in FIG. 5. FIG. 7 is a sectional view corresponding to FIG. 5 showing how to change the diameter of the inlet channel and the insertion of an instrument in the form of a punch. FIG. 8 is a transverse sectional view along line 8--8 in FIG. 7. DESCRIPTION OF THE PREFERRED EMBODIMENT In order to make the following description more comprehensible, it is pointed out that the trocar comprises a body (1) equipped with a tip (2). The body comprises a tube (1b) underneath a bell-mouthed part (1a). Part (1b) is axially drilled at (1c) over its entire length whereas part (2) has an internal through-channel (2a). Hole (1c) and channel (2a) are in coaxial alignment. The surgical instrument that is to be used is inserted through internal channel (2a) in tip (2) so that it protrudes beyond the free end of body (1). Bell-mouthed part (1a) has an internal recess (1d) that communicates with channel (2a) and hole (1c). This recess accommodates a swivel valve (3) of which the axis of rotation is situated in tip (2) and which is held in the shut-off position by spring (4). In the position where channel (2a) and hole (1c) are shut off, valve (3) rests against its seat (2b) comprising a seal (2c). Valve (3) is retracted under the effect of inserting the instrument; it can also be operated externally by simply exerting finger pressure on operating handle (3a) if the operator needs to extract delicate "objects" from the organism during an intervention. According to one basic characteristic of the invention, tip (2) is fitted with internal features that can be operated externally and are capable of modifying the diameter of channel (2a) in order to match it to the diameter of the instrument to be inserted. As will be shown in the rest of this description, these features are shaped in order to ensure leaktightness inside the trocar after the instrument is inserted. In the embodiment shown in FIGS. 1 to 4, the features consist of a reducing adapter in the form of a hinged arm (5) actuated by lever (5b). This arm (5) has at least one hole (5a) of diameter less than that of channel (2a) in tip (2). The arm is hinged at (5c) so that it swivels angularly when force is exerted on lever (5b) in order to line up holes (5a) and (2a) (FIGS. 3 and 4). Reducing adapter (5) is accommodated transversely a housing (2e) formed in the thickness of tip (2). Said housing (2e) is designed either to coaxially align hole (5a) with channel (2a) (FIG. 3) or to completely free channel (2a) (FIGS. 1 and 2), depending on the angular position of lever (5b). The axis of rotation (5c) of reducing adapter (5) is parallel to the axis of the trocar. It is clear that, depending on the angular position of reducing adapter (5), it is possible to modify the diameter of the inlet of channel (2a) in order to match it to the diameter of the instrument to be used. In order to ensure leaktightness, a seal (7) is fitted in the inlet of insertion channel (2a) in tip (2) upstream from hinged arm (5) and downstream from valve (3). The effect of this seal (7) is to ensure leaktightness of the instrument whose diameter corresponds to that of channel (2a), i.e. in the retracted position of reducing adapter (5) (FIGS. 1 and 2). In order to ensure leaktightness in the case of an instrument of smaller diameter, i.e. when arm (5) is swivelled so that it lines up its hole (5a) with hole (2a) (FIG. 3), said hole (5a) has an internal seal (6) capable of cooperating with the body of the corresponding instrument. Note that disposable tip (2) is connected to body (1) by a click-on system comprising a seal (2d) that ensures complete leaktightness between the two parts of the trocar. In addition, in order to make it possible to re-inflate or deflate the peritonium, the trocar is equipped with a slide valve (8) that is opened or closed by a quarter-turn cock (8a). In another embodiment, the reducing adapter consists of a spherical plug (9) having at least two through-holes (9a) (9b). These holes are of different diameter and are capable of being axially aligned with channel (2a) under the action of angular swivelling of lever (10). Advantageously, plug (9) has two through-holes arranged in two orthogonal planes. Hole (9a) is of smaller diameter than channel (2a) whereas the diameter of hole (9b) is equal to the diameter of said channel. As previously, in order to ensure leaktightness after inserting the instrument, each hole (9a) (9b) has an internal seal (11). It is therefore sufficient to orientate the plug by actuating lever (10) in order to coaxially align either hole (9a) (FIGS. 5 and 6) or hole (9b) (FIGS. 7 and 8) with channel (2a) depending on the diameter of the desired instrument. According to another characteristic, body (1) of the trocar has external annular peripheral ribs (1c) over all or part of its length. The advantages are apparent from the description with special emphasis being placed on the following points: the facility to easily disassemble the tip and body of the trocar with a view to obtaining a disposable tip, the production of a compact, ergonomic trocar that includes, in its tip, a reducing adapter and a sealing valve that can be operated externally with one hand without having to release the trocar, the facility to modify the diameter of the insertion channel in the tip depending on the diameter of the instrument to be used, the facility to extract delicate "objects" during an intervention by manually retracting the sealing valve by using an external lever, the effectiveness of the result thus obtained.

1a

FIELD OF THE INVENTION This invention relates to appliances for use with stomas. BACKGROUND OF THE INVENTION An ileostomy is a surgical procedure in which the small intestines are surgically rerouted to the outside of the body. People require an ileostomy when the large intestines or rectum are affected by injury of disease to the point where they can no longer function and must be removed. Conditions which require removal of the large intestine or rectum include ulcerative colitis, polyposis, and tumors. When a surgeon removes the large intestine or rectum from a patient, the surgeon must also make a new passageway for removal of waste from the body. The surgeon does this by connecting the end of the small intestine (or a portion of the large intestine) to the outside of the body, and creating an opening in the skin. The opening in the skin is call a stoma, and is usually located on the right side of the abdomen near the waist. Related surgical procedures include the colostomy, in which colon is surgically rerouted to a stoma on the body, and the urostomy, in which the urinary tract is rerouted to a stoma on the body. Each of these ostomy procedures requires similar post-operative hygiene and appliances. After ileostomy surgery, patients are relieved from the painful conditions requiring the ileostomy. However, the patients must use special appliances and use special care to remove waste material from the body through the ileostomy and stoma. Patients must wear a pouch over the stoma to collect waste material. The pouch is connected to the stoma with a fluid connector and a barrier seal around the stoma. The barrier seal may be is glued to the body around the stoma with special adhesive. The barrier seal is absorbent so that is absorbs any leakage that might occur through the fluid connector. The appliance may be disposable, in which case the pouch, fluid connector, and barrier seal are replaced as necessary. The appliance may be reusable, in which case the pouch must be emptied often, the fluid connector must be cleaned and reinstalled, and the barrier seal must be cleaned or replaced. The barrier seal must be replaced every two or three days. With proper vigilance to the hygiene requirements of the appliances, irritation of the stoma and skin around the stoma can be limited and odor associated with leakage can be avoided. With these special appliances, patients can engage in a very normal lifestyle, except for the time necessary to maintain the appliances and care for the stoma and experience of discomfort attendant to typical shortcomings of available appliances. The hygienic regimen is, however, burdensome and imperfect in avoiding irritation. Any device or method that lessens the burden on the patient and reduces the irritation of the stoma and surrounding skin will be useful for all ileostomy patients. The stoma is a generally circular or annular opening in the abdomen. It is formed by piercing the skin to form a hole, pulling the ileum (the end of the small intestine) through the hole in the skin, and everting a short segment of the small intestine (turn it inside out), and suturing the everted segment to the skin. The sutures create a circle of stitches around the stoma. The stoma protrudes slightly from the surface of the skin, and the suture circle is slightly elevated. The typical ileostomy pouch has a stoma opening which is aligned with the stoma, so that effluent flows from the small intestine through the stoma and stoma opening into the pouch. The pouch is held on the body, and stoma opening held in place over the stoma, with a faceplate that is taped to the body. The faceplate has a stoma opening which is ringed by a flanged fluid connector which connects to the stoma opening of the pouch. The stoma opening is the same size or slightly larger than the stoma, and may include a flexible silicone gasket with an opening the same size as the stoma. The faceplate is taped to the body with an adhesive disk call a barrier seal. The barrier seal is adhesive on both sides, and tapes the faceplate to the body. (The faceplate may also be glued to the body. Many patients also apply microporous tape around the faceplate before attaching the pouch to the faceplate, and some manufacturers supply the faceplate with a picture frame of tape.) The barrier seal is also absorbent, so that it absorbs any effluent that leaks from the stoma connection to the pouch. The pouch is fitted over the flange of the faceplate, and locked in place with a snap fit closure (like an aspirin bottle cap). This system is sometimes referred to as a two piece system, and may be described in various ways. For example, ConvaTec refers to the faceplate/barrier seal assembly as a skin barrier with a flange. The barrier seal is sometimes referred to as a skin seal, barrier ring seal, or wafer or disc. In contrast to the two-piece system, a one piece system integrates the before mentioned components into one disposable unit who's overall function is similar to the two piece system. In another type of pouch, the stoma opening on the pouch has a tacky silicone ring which fits directly around the stoma, and the adhesive barrier seal connects the pouch directly to the skin around the stoma. Non-adhesive pouches use a similar setup, with an O-ring seal fitting around the stoma and the stoma opening of the pouch fitting directly over the O-ring, and the entire assembly is held on the body with a belt. The integrity of the entire appliance depends on the effectiveness of the skin barrier seal. The barrier seal is intended to absorb effluent and keep it from contacting the skin around the stoma (referred to as the peristomal skin). When it fails in protecting the skin, the peristomal skin becomes irritated or infected. The skin barrier will not adhere to irritated or infected skin, and will not work to protect the skin. Thus any outbreak of peristomal skin irritation or infection can be very difficult to cure. SUMMARY The inventions described below include several improvements for ostomy appliances. The faceplate/barrier seal assembly includes a dispersive blotter ring installed between the faceplate and the barrier seal to distribute leaked effluent more evenly around the stoma opening, thereby prolonging the useful life of a barrier seal. The typical ring seal is improved by the addition of a highly conformal silicone foam ring. The silicone foam exhibits a balance of resilience and conformance beyond that of silicone ring seals, and expands into stoma concavities and irregularities that would otherwise remain as leaks. The silicone foam ring is suspended over the stoma with a suspension membrane which allows the foam ring to move and follow axial and radial displacements of the stoma relative to the faceplate. Addition of a superiorly located compressing and supporting ring assists in urging the silicone foam ring into contact with the stoma at its base. The faceplate assembly provides better protection to peristomal skin and prevents leaks better than currently available faceplate assemblies. A method of making silicone foam without use of bio-incompatible constituents or processing substances is also prevented, so that the device may be made without fear of harm to the body due to chronic exposure to chemicals diffusing from the ring seal. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an illustration of the application of the flange in an ileostomy system. FIG. 2 illustrates the anatomy of a stoma and the structure of the flange in an application of the flange. FIG. 3 is a cross section of an ostomy pouch faceplate. FIG. 4 is a cross section of an ostomy pouch faceplate. FIG. 4a is a cross section of a subassembly of the ostomy pouch. FIG. 5 illustrates an embodiment of the main seal. FIG. 6 illustrates an embodiment of the main seal. FIG. 7 illustrates an embodiment of the main seal. FIG. 8 illustrates an embodiment of the main seal. FIG. 9 illustrates an embodiment of the main seal. FIG. 10 illustrates an embodiment of the main seal. FIG. 11 illustrates an embodiment of the main seal. FIG. 12 illustrates an embodiment of the main seal. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows an overview of the installation of the ostomy faceplate and coupling system. The ileostomy is used to illustrate the invention. The normal pathway of nutrients through the digestive system includes the stomach 1, which discharges pre-digested sustenance to the small intestines 2. The small intestines terminate and communicate with the large intestine 3 (also called the colon). The distal portion of the small intestine which connects to the large intestine is referred to as the ileum 4, as is illustrated in phantom in its natural condition, and illustrated in the re-routed ileostomy position in solid lines. When the ileostomy is performed, the ileum is divided through, severing the small intestine from the large intestine. The cut end of the ileum is inserted in a hole in the abdomen to form a stoma 5. (The large intestine may be removed, except in occasional cases where the ostomy is intended to be temporary and the large intestine is still in useful or repairable condition, where the cut end of the large intestine is surgically closed.) The faceplate 6 is installed over the stoma, and the pouch 7 is snap-locked onto the faceplate. FIG. 2 shows the faceplate and stoma in more detail. The stoma 5 has been installed, and is defined by the ileum 4, ileum lumen 8, the everted or out-turned distal portion 9, and the sutured edge 10. The stoma typically has side walls 11 and a rim 12 which protrudes slightly from the abdomen. To aid in understanding the arrangement of the various parts of the faceplate, line 13 indicates the axis of the stoma and the ileum. Movement or placement of components along this line is referred to as axial movement, and positions close to the body along this line are referred to as posterior, and positions farther away from body along this line are referred to as anterior. Line 14 defines a radius of the stoma and stoma opening, and movement away from or toward this line is referred to as radial movement. Lines 15 and 16 indicates define the plane of the abdomen, and movement of the stoma and faceplate components around this plane is referred to as planar movement. Movement along line 15 and line 16 are referred to as vertical and lateral movement, or planar movement. The stoma will move relative to the faceplate along each of these lines during normal activities. Stomas are generally symmetrical about the lumen of the ileum, but may certain areas of concavity 17 due to the natural anatomy of the small intestine or an asymmetric healing process. The stoma 5 is surrounding by normal abdominal skin, referred to as the peristomal skin and marked as item 18. The mucosal lining 19 of the ileum is exposed on the walls and rim of the stoma. The faceplate is mounted on the abdomen 20. The ring seal 21 is mounted on the faceplate, and includes a stoma opening. The pouch coupling ring 22 is secured to the faceplate and serves to couple the pouch of the faceplate with a snap-lock fitting. The inner edge of the stoma opening includes and is defined by a large bead 23 of silicone foam. The silicone foam is chosen because it is a material having a balance of resilience and conformance such that the bead will exert constant, light, radial pressure on stoma and rebound whenever pressed by movement of the stoma to maintain sealing contact with the stoma, yet will yield to protuberances in the stoma and expand into concavities in the stoma (as illustrated by the expansion of the ring seal into the concavity at 17). (Current ring seals are made of polyethylene film, which is not elastomeric, and are not capable of expanding into concavities, and patients must depend on sloppy stomahesive compound (like plumber's putty or dental adhesive) to fill gaps between the ring seal and the stoma. It also eventually dissolves and becomes ineffective as a gap filler.) The silicone foam may be an open celled foam or a closed cell foam. The silicone foam has an impermeable outer skin layer, but may be provided with a porous outer surface. A low modulus (that is, highly deflectable under load or deflectable under very low load), elastomer elastic material such as silicone foam used in the main seal provides a constant gentle sealing force around the stoma which is sufficient to provide a seal against leakage but slight enough to avoid stomach irritation. FIG. 3 shows a cross section of the ostomy faceplate. The entire assembly is mounted on the abdomen 20, with the ileum 4 penetrating the abdomen to form the stoma 5. The faceplate assembly rests on the abdominal wall around the stoma. The barrier ring 24 comprises a compound of gelatin, pectin, polyisobutylene and glycerin. This barrier ring absorbs stoma mucus and expands as it absorbs mucus. It eventually liquifies to be expelled past the seal 29 into the pouch, or to be cleansed during maintenance and regular changing of the ostomy faceplate. (The barrier ring may be a conventional barrier ring, or it may be a barrier ring made of the new compound described below.) Immediately above the barrier ring, a blotter ring 25 is installed. The blotter ring blots up leaking liquid and disperses it around the circumference of the barrier ring, keeping liquid from pooling in any one portion of the barrier ring. This prevents non-uniform degradation or dissolution of the skin barrier ring, which is typically the cause of premature failure. The blotter ring is made from a porous material such as cloth, sponge, non-woven mat or other absorbent or wicking material which can distribute absorbed liquid uniformly over the circumference of the blotter ring. A few layers of polyester wipes sold under the tradename CHIX (Johnson & Johnson) tacked together with RTV silicone work well as blotter ring material. The blotter ring is fixed to the silicone support washer with an affixment of silicone 26 which may be formed of silicon glue (the affixment illustrated forms an annular boss around the bottom of the support membrane), or the blotter ring may be molded into the support washer during manufacture of the washer. The blotter ring may also be supplied as a replaceable structure, with blotter material fixed to a ring which snaps into a receiving groove on the support membrane. In FIG. 3, the main sealing function of the faceplate is performed by the main seal ring 29. The main seal is toroidal, shaped like a donut, and is made of a low modulus foam encased in a flexible toroidal skin made of silicone or other flexible material. The inside diameter of the main seal ring is slightly smaller than the stoma diameter. It gently circumscribes the stoma and conforms to the outer contour of the stoma, and seals the stoma so that no effluent leaks past the main seal toward the barrier ring, blotter ring and peristomal skin. Thus, should the stoma outline have any concavity, the foam filled toroid is resilient and tensioned enough to expand into the concavity and followed any contour. The foam filled toroid is resilient enough to elastically follow movement of the stoma relative to the faceplate, and to follow the natural enlargement, shrinkage and deformation of the stoma that occurs during peristaltic actions (the natural squeezing of the intestines which forces stool outward) and daily activities. Contact with the stoma occurs over a relatively large surface area of the mucosal surface on the side wall of the stoma, and this minimizes stoma contact pressure and stoma irritation. An additional sealing enhancement occurs naturally by the continual supply of stoma mucosal secretion that acts like a filler and lubricating medium (like grease on an O-ring) that allows the main sealing ring to conform more effectively to the stoma surface, resulting in an enhanced seal. The main seal 29 is supported by the seal suspension membrane 30. The seal suspension membrane is made of silicone or other very flexible and low modulus material, and may be secured to the main seal with a layer of dissolved silicone applied between the two (the dissolved silicone is painted on like glue). Besides affixing the main seal to the faceplate assembly, this seal suspension membrane isolates liquid on either side of the main seal. It supports the main seal as the main seal elastically follows the stoma as it changes shape, size and radial and planar position during its peristaltic maneuvers. Thus both the main seal and the main seal suspension membrane may resiliently move and deform in response to changes in stoma size and location to maintain a firm seal between the stoma and the main seal. The main seal suspension membrane and the blotter ring are fixed to the silicone support membrane 31. The silicone support membrane is a relatively stiff membrane that fixes the seal suspension membrane and the main seal within the vicinity of the stoma, close to the abdomen and aligned axially within the elastic limits of the suspension membrane and the main seal. It keeps the main seal from drifting too far away from the abdomen and stoma. The closer the main seal is to the abdomen, the less stoma surface area is exposed behind the main seal, leaving less mucosal surface exposed to the skin barrier and therefore resulting is lower effluent load on the skin barrier. The support membrane is provided with relief holes 32 which pass from the lower side to the upper side of the membrane. These holes serve to allow any effluent trapped between the suspension membrane and the support membrane to pass through the support membrane into the ostomy pouch opening defined by the coupling ring. The support membrane lies underneath (posterior to) the pouch coupling ring and is attached to the pouch coupling ring with affixments 33. As illustrated, these affixments are beads of silicone glue. However, the pouch coupling ring may be attached to the support membrane with a simple layer of adhesive, or it may be made integral with the support membrane. The pouch coupling ring 34 lies above (anterior to) the support membrane, and serves to couple the ostomy pouch with the faceplate. The coupling ring is made of tough slightly flexible plastic such as polyethylene, polypropylene or polystyrene. The base flange portion 35 rests on the support membrane 31, and the cylindrical ring 36 extends outwardly from the base flange. At the outward edge of the cylindrical ring, an internal flange 37 and external locking flange or lip 38 are integrally formed on the ring. These flanges interact with the receiving ring on the ostomy pouch to couple the pouch to the faceplate (one or the other, or both, may be provided in the coupling). The entire faceplate assembly is taped to the body with the tape 39, which is provided in the form of the circular picture frame tape. Commercial embodiments will probably include a peel away backing that is removed just prior to installation. FIG. 4 includes most of the elements of FIG. 3, with some additional features. A support ring 40 is provided under the inner circumference of the support membrane, trapped between the support membrane, the suspension strut 41 and the main seal. The purpose of this support ring is to gently urge the main seal downward, toward the abdomen, and allow the main seal to move more extensively in radial and planar directions relative to the support membrane. The main seal is suspended from the support membrane by any number of suspension struts 41, which extend downwardly from the support membrane. These suspension struts permit radial and planar movement and expansion of the support ring and main seal, but are biased against axial superior and inferior movement, thus prohibiting excessive movement of the main seal away from the abdomen. The struts also inhibit the entire structure of the main seal, compression ring and support membrane from everting outwards (i.e., turning inside out). The axial widths of the main seal, compression ring and struts are chosen such that the support membrane will slightly flex outward when the faceplate is installed (acting like an axial spring). This causes a gentle, constant inwards force that maintains the main seal position at the stoma base. The structure acts like a short, flexible tube, which bends to follow the stoma, but whose length remains relatively constant, keeping the seal close to the abdomen. As previously mentioned, the blotter ring may also be supplied as a replaceable structure. FIG. 4a illustrates an embodiment of the blotter ring, suspension membrane and support membrane assembly in which the blotter ring is mounted within a circular frame 46. The circular frame has a snap fit bead 47 around its anterior surface which fits into the snap fit groove 48 in the support membrane. Construction in this manner allows occasional change of the blotter ring without the need to change the other parts. The main seal suspension membrane can also be mounted on a circular frame 49 with an anterior snap fit bead 50 which fits into a snap fit groove on the support membrane. Simpler embodiments of the main seal may be employed with the faceplate as constructed above. FIG. 5 illustrates an embodiment in which the main seal is a straight edged ring seal 51, where the inner edge 52 of the seal is not enlarged and is merely beveled with a round edge. FIG. 6 illustrates an embodiment in which the main seal is a ring seal 51 which has a bead of enlarged thickness around the inner edge 52 of the seal which defines the stoma opening. FIG. 7 illustrates an embodiment in which the main seal is a ring seal in which the inner edge of the seal is curled upward to define a rounded inner edge of the stoma opening. FIG. 8 illustrates an embodiment in which the main seal is a ring seal in which the inner edge of the seal is curled upward and hemmed to define a rounded inner edge of the stoma opening. The hem may be filled with air, foam, liquid or gel to enhance the resilience and conformance of the inner edge of the stoma. FIG. 9 illustrates an embodiment of the main seal in which the main seal is made of a ring seal in which a silicone foam ring 29 is mounted on the posterior side of the stoma opening of the suspension membrane 30. FIG. 10 illustrates an embodiment of the main seal in which the main seal is suspended from the suspension membrane 30 with an integrally formed resilient cylinder 53. This resilient cylinder is biased in the downward direction by the mass of the annular boss 54 on the inner edge 52 of the suspension membrane 30. FIG. 11 illustrates an embodiment of the main seal in which the main seal 29 is comprised solely of a flat washer of silicone foam secured directly to the faceplate and the pouch coupling ring 34. The main seal hole diameter is chosen to maximize sealing quality and minimize unnecessary stoma pressure. The preferred diameter is slightly smaller than the stoma diameter that, when applied, will result in a gentle squeezing of the stoma. FIG. 12 illustrates a simple improvement over commercially available faceplates. The skin barrier 24 lies immediately on the peristomal skin 18. The sealing ring is a multi-layered ring seal comprising a thin flange 56 made of polyethylene disposed over the skin barrier. The pouch coupling ring 34 is secured to the polyethylene layer. The polyethylene is nonelastomeric, and does not elastically yield when it moves relative to stoma. It also stretches under the force applied by the stoma, resulting in a loose seal between the ring and the stoma. (In the commercially available faceplate, the stoma hole is sized to bring the skin barrier 24 as close as possible to the stoma but limited minimally by the risk of irritating the stoma by having the plastic film too constrictive. The actual sealing mechanism is dependent upon the skin barrier compound to swell and expand around stoma, thereby inhibiting effluent from reaching peristomal skin.) To improve the sealing of the polyethylene ring seal, a thin layer of expanded PTFE 57 (expanded Teflon®, for example) or other elastomer, with an inside hole diameter that is smaller than the hole it augments, is secured to the polyethylene ring seal, forming a flexible membrane over the ring seal. The expanded PTFE is applied over or under the ring seal, and is secured with a thin layer of adhesive. This additional membrane forces the partially dissolved skin barrier 24 to form a larger, more robust "turtle neck" around the stoma (increasing surface area contact of skin barrier compound and stoma), that elastically follows any stoma motion. The sealing mechanism is now a combination of swelled skin barrier compound and the more positive seal of an elastomeric ring. In one embodiment of the main seal'application, especially when using a skin barrier compound that swells to form a "turtle neck, " the elastomeric main seal effectuates two primary functions, which can alternate in import depending upon the condition of the turtle neck formation. The first function, which has been previously described, depends upon contact of the main seal with stoma for the primary seal. The second function is to elastically circumscribe the "turtle neck" itself and urge it to follow any stoma motion. The swelled skin barrier compound acts like a thin intermediate layer of material between the stoma and main seal (like a thick layer of grease or an O-ring). The ring seals of FIGS. 3 through 12 are made of very flexible and soft silicone which is formulated to enhance conformance to the stoma. Available silicone materials are generally unsuitable for use. RTV 5220 silicone has suitable elastomeric qualities of low modulus and good elasticity, and works well until it gets fagged out, but is not FDA approved. FDA approved silicones are not very flexible, and have relatively high modulus, and are resistant to deformation to a degree that is unsuitable for long term contact with the stoma. However, by cutting FDA approved silicone such as GE IS-802 with SF 18-350 silicone fluid (also referred to as silicone oil or polydimethylsiloxane), silicone can be formulated with a very low modulus. The barrier seal described above may be made of conventional barrier seal compounds, which are typically made of a suspension of polyisobutylene, gelatin and pectin. These compounds are adhesive and absorbent. In other ostomy appliance applications, barrier seals made with these compounds are used as the main fastening element fastening the faceplate to the skin (the high tack characteristics to provide immediate protection to peristomal skin. The adhesive property is not critical in the embodiments of FIGS. 3 and 4 because the picture frame tape is sufficient to hold the device in place, and the main seal is more effective than other main seals. For these reasons, the proportion of polyisobutylene in the barrier seal compound used with these embodiment can be made very low. The conventional barrier seal compound may be replaced with a new compound which has significantly longer life (it may be used for a week or more before requiring replacement). The new compound that has effective odor blocking characteristics, optimal tack, and is easier to clean up. The compound is a mixture of compounds mixed according to the following recipe: The components comprise 1.9 mm gelatin, 0.5 mm pectin, 0.5 gm carboxymethylcellulose (could use `Poly-Grip`), 1.0 gm glycerin, 0-0.5 gm polyisobutylene and 6.0 gm water. The proportion of polyisobutylene can be minimized, even to zero. The components are mixed and heated to near boiling until thick paste consistency. While hot, the mixture is poured onto a silicone covered release plate, and leveled to 0.1" thick (i.e. flattened with another release plate). The flat sheet of barrier seal material is cooled for about 10 minutes or more. After cooling, the sheet is dried at room temperature for about 36 hours (the release plates may be removed and the sheet may be placed on a drying screen). After drying, the sheet is ready for use and may be cut to convenient size, and the appropriate sized ostomy hole may be cut into the sheet. While this recipe works well for small batches, large production size batches will likely be made with methods more suitable to mass production. The amounts listed above indicate the desired proportions of the constituent compounds, and in production these proportions will most likely be expressed in reference to much larger amounts. However, the approximate proportions of 33.33 grams of polyisobutylene, 83.33 grams of carboxymethylcellulose, 83.33 grams of pectin, and 316.66 grams of gelatin per kilogram of water will provide the skin barrier of optimal tack and consistency, increased durability and easier cleanup. The proportion of polyisobutylene is extremely low compared to other skin barrier compounds, and may be varied in the range of zero to 100 grams per kilogram of water, and preferably within the range of 20-60 grams per kilogram of water. Finally, polyisobutylene may be left of the mix entirely. (Prior art systems have used high polyisobutylene content skin barrier compounds in order to provide high adhesive properties.) The skin barrier compound may be provided with additionally flexibility by the addition of a small amount of glycerin, in proportions of about 100-200 grams (preferably 170 grams) per kilogram of water. In the embodiments which use foam as a constituent of the main seal, the foam may be made according to previously known methods of making silicone foam. However, the known methods are suspect for the inclusion of various bio-incompatible compounds or use of bio-incompatible compounds in their manufacture and subsequent leaching or evaporation out of the material and into contact with the body. To overcome the possibility of inclusion of such bio-incompatible compounds in the seal, the foam may be made in a new method which uses known biocompatible substances, namely silicone and water. In this new method, RTV silicone (plus any ingredients that alter its original modulus, i.e., silicone oil) is thoroughly mixed together with a solution of about 0.18 grams of water and 0.72 grams of acetone per gram of RTV silicone. The resultant paste is then pressed into a mold of appropriate shape, avoiding air entrapment. The paste is allowed to partially set at room temperature in the mold for approximately 10 to 15 minutes. After this brief period of setting, the mold and paste are heated in an oven for about ten hours or more at a temperature in the range of about 70 to 95° centigrade. The final foam density, pore size or bubble size, and resultant resilience of the foam is determined mainly by the curing temperature. Many combinations and variations of temperature and cure time and proportions in the ingredients will provide foams of suitable resilience and conformance. A single combination may prove universally ideal with more extensive experience in clinical use. More likely, it will be best to provide a variety of foams of differing resilience and conformance for clinical use in order to suit the varying preference of individual patients. Many variations in the exact mix of water and acetone are suitable for making a silicone foam. Acetone may be replaced the composition with any substance which acts as a solvent for water and silicone. Silicone has been mentioned as the material from which many components of the faceplate are made. This is because the biocompatability of silicone is well proven. Silicone can be made in formulations which exhibit a wide range of physical strength, flexibility, stiffness, and modulus. These formulations can be employed as indicated above. However, silicone is just one of many elastomers and plastics which can be used in the various components. While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. It is specifically contemplated that new materials will be discovered to replace material currently preferred for use in the various parts of the faceplate, including the barrier skin seal, the main seal and the blotter ring. Other embodiments and configurations may be devised without departing from the spirit of the inventions and the scope of the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to an in-sink dishwasher for automatically washing household dishes without requiring the physical space of a built-in automatic dishwasher. The invention further relates to an in-sink dishwasher in combination with a cutting board adapted for mounting to a lid of the in-sink dishwasher to prevent the relative movement between the cutting board and the in-sink dishwasher. 2. Description of the Related Art In-sink dishwashers use the bowl of a sink to form part of the dishwasher housing that defines a portion of the wash chamber, with the open top of the bowl providing access to the bowl. A liquid recirculation system effects the spraying of a wash liquid throughout the bowl to clean any dishes placed within the wash chamber. A lid covers the open top of the bowl when the in-sink dishwasher is being used to prevent the splashing or spraying of the recirculating wash liquid out of the open top of the bowl. It is anticipated that users of in-sink dishwashers will use the lid as an extension of the countertop surrounding the sink when the lid is in the closed position. It is further anticipated that the user will place objects on the lid as part of the normal meal preparation process. One such anticipated object is a cutting board for use in cutting food items as part of meal preparation. For accuracy in cutting and to reduce spillage of items on the cutting board, it is desirable to limit the relative movement between the cutting board and the lid. SUMMARY OF THE INVENTION The invention relates to a dish-cleaning appliance comprising a sink having a bowl with an open top for providing access to the bowl. A rack for holding dishes and the like is received within the bowl. A liquid recirculation system sprays liquid onto the dish rack to effect the cleaning of any dishes on the rack. The lid is mounted to the sink and is movable to selectively cover the open top of the bowl. A cutting board is positioned on top of the lid and a releasable coupling secures the cutting board to the lid to substantially prevent the relative movement between the cutting board and the lid. The releasable coupling may comprises a first interactive element on the lid and a second interactive element on the cutting board. The first and second interactive elements interact to substantially prevent the movement of the cutting board relative to the lid. The first interactive element can be one of a projection and a recess and the second interactive element can be the other of the projection and the recess. The projection is sized to be received within the recess to substantially prevent the movement of the cutting board relative to the lid. In one embodiment, the projection extends from a lower surface of the cutting board and the recess is formed in an upper surface of the lid. The projection can comprise multiple projections. Correspondingly, the recess can comprise multiple recesses. The recess preferably lies entirely within the perimeter of the lid. The first interacting element can also comprise a recess formed in an upper surface of the lid and the second interacting element can comprise multiple spaced feet extending from a lower surface of the cutting board and received within the recess. The recess comprises a peripheral side wall and the feet are located on the cutting board such that the feet abut the peripheral side wall when the feet are received within the recess. The recess peripheral side wall is beveled and at least one of the feet has an angled side wall that complements the bevel of the peripheral side wall. The feet preferably have a height such that the feet touch a lower surface of the recess when the feet are received within the recess. The feet height is also such that the lower surface of the cutting board lies above the lid. The sink can comprise a second bowl that is spaced from the first bowl. The cutting board can be sized such that a portion of the cutting board spans the area separating the first and second bowls. The portion of the cutting board spanning the first and second bowls may have an edge that is substantially coplanar with a portion of a side wall of the second bowl adjacent the first bowl. The cutting board can be made from a variety of materials, such as wood, plastic, and stone. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 is a perspective view of an in-sink dishwasher according to the invention, with the in-sink dishwasher shown mounted in a cabinet, the sink being of a double-bowl configuration and the one bowl forming part of the in-sink dishwasher having a lid, shown in an opened position, for covering the one bowl. FIG. 2 is a perspective view substantially identical to FIG. 1 except that the lid is shown in the closed position and a cutting board is shown positioned on the lid upper surface. FIG. 3 is a schematic illustration of the major components of the in-sink dishwasher. FIG. 4 is a top view of the lid of FIG. 1 and illustrating the upper surface of the lid. FIG. 5 is a bottom view of the cutting board of FIG. 1 and illustrating the lower surface of the cutting board. FIG. 6 is a sectional view taken along line 6 — 6 of FIG. 2 and illustrating the releasable coupling securing the cutting board to the lid along a transverse direction. FIG. 7 is a sectional view taken along line 7 — 7 of FIG. 2 and illustrating the releasable coupling securing the cutting board to the lid along a longitudinal direction. FIG. 8 is a bottom view of a cutting board with a second embodiment releasable coupling. FIG. 9 is a sectional view similar to FIG. 7 and illustrating the second embodiment releasable coupling. FIG. 10 is an enlarged sectional view of a foot forming part of the second embodiment releasable coupling. DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 illustrates an in-sink dishwasher 10 mounted in a traditional cabinet fixture 12 having doors 14 providing access to the cabinet interior where the lower portion of the in-sink dishwasher 10 is located. The in sink dishwasher 10 is illustrated in the environment of a double-bowl sink 16 comprising a first bowl 18 and a second bowl 20 , with each bowl having a bottom wall 25 and a peripheral side wall 19 , 27 , respectively. The first bowl 18 performs the function of a traditional sink bowl and includes a drain opening 21 . The second bowl 20 performs the dual function of a traditional sink bowl while also forming a portion of the housing for the in-sink dishwasher. The first and second bowls 18 , 20 are spaced from each other to define an intervening flange portion 22 that intersects a peripheral flange 24 surrounding both of the bowls 18 , 20 . Preferably, the double-bowl sink is made from stainless steel. A traditional water faucet 28 is located in the peripheral flange 24 of the double-bowl sink and provides water to either of the first and second bowls 18 , 20 . Referring to FIGS. 1 and 2, the in-sink dishwasher 10 comprises a wash chamber 30 that is defined by the second bowl 18 , which has an open top. A lid 32 is hingedly mounted to the peripheral flange 24 of the double-bowl sink 16 and is movable between an opened position as shown in FIG. 1 and a closed position as shown in FIG. 2 . A drain 34 along with a water inlet 36 are provided in the bottom of the second bowl 20 and provide for the draining and introduction of water from and into the wash chamber 30 . The drain 34 serves as a drain during the use of the bowl 20 as a traditional sink and when used as a wash chamber 30 for the in-sink dishwasher 10 . FIG. 3 schematically illustrates the major components of the in-sink dishwasher 10 , which include a rack 40 comprised of multiple wire segments for holding various dishes and utensils. The exact shape and configuration of the rack 40 is not germane to the invention and is preferably made similar to those found in automatic dishwashers. A spray arm 42 is preferably mounted to the bottom of the rack 40 such that the spray arm is free to rotate relative to the rack 40 and is removed from the wash chamber when the rack is removed. The spray arm 42 couples with the water inlet 36 when the rack 40 is positioned within the second bowl 20 . The drain 34 has one outlet that is fluidly coupled to an in-line water heater 44 . The output of the water heater 44 is received as input to a recirculation pump 46 , whose output is sent to a valve 48 forming part of the water inlet 36 . The drain 34 , water inlet 36 , in-line water heater 44 , recirculation pump 46 , valve 48 , and spray arm 42 collectively form a recirculation system for recirculating wash liquid throughout the wash chamber 30 . The drain 34 has another outlet that is fluidly connected to a drain pump 52 . The output of the drain pump 52 is fluidly connected to the traditional drain line for the second bowl 20 . The drain pump 52 provides for a positive draining of liquid from the wash chamber 30 , such as, for example, when it is no longer desire to recirculate the wash liquid with the recirculation system. A controller 54 , preferably a microprocessor-based controller, is electronically coupled to the in-line heater 44 , recirculation pump 46 , and drain pump 52 to control their respective operation. If the valve 48 is an actuated valve, such as a solenoid-actuated valve, instead of a check valve, then the controller 54 can also be connected to the valve 48 and control its operation. The controller 54 operates the in-line heater 44 , recirculation pump 46 , and drain pump 52 to implement a wash cycle. Preferably, the wash cycle is one of many well-known wash cycles stored in the memory of the microprocessor. A user interface 58 is located adjacent the second bowl 20 and is electronically coupled to the controller 54 . The user interface 58 permits the user to select the desired wash cycle from the multiple wash cycles stored in the memory of the microprocessor and enter any necessary or optional operating data or parameters for the wash cycles. Referring to FIG. 4, the top of the lid is shown in greater detail and comprises an upper surface 62 having a generally planar contour and in which is formed a recess 64 . The recess has an outer periphery 65 that is substantially rectangular and extends laterally across the upper surface 62 . Preferably, the recess does not extend all the way to the peripheral edge of the lid. A series of longitudinally extending projections or ribs 66 are located in the recess 64 and effectively divide the recess 64 into multiple or sub-recesses 68 . The ribs 66 are preferably of a height such that they do not extend beyond the plane defined by the upper surface 62 . Referring to FIGS. 2 and 5, a cutting board 70 can be positioned on the lid 32 when the lid is in the closed position. The cutting board is preferably sized such that at least a portion 71 of the cutting board spans the space between the first and second bowls. Preferably the distal edge of the cutting board terminates at the first bowl and does not substantially overlie the first bowl. The cutting board is preferably made from wood. However, the material of the cutting board is not germane to the invention. Other suitable materials such as plastic and stone can also be used for the cutting board. Referring to FIG. 5, the cutting board 70 comprises a lower surface 72 having a generally planar contour and from which extends a projection 74 whose outer periphery 75 is complementary to the outer periphery 65 of the lid recess 64 . Multiple longitudinal grooves 76 are formed in the projection 74 to effectively sub-divide the projection 74 into multiple projections or sub-projections 78 . Preferably, the grooves 76 are located in the projection 74 such that they correspond to the same relative location as the ribs 66 in the recess 64 , resulting in each of the sub-projections 78 having a generally longitudinal shape that corresponds and is complementary to one of the sub-recesses 68 . The cutting board further includes a portion 82 that overlies the flange 22 separating the bowls 18 , 20 when the cutting board is mounted to the lid. The portion 82 preferably terminates in an edge 84 that aligns with the peripheral side wall 19 when the cutting board is mounted to the lid. While it is within the scope of the invention for the cutting board to be of a length such that the edge 84 of the portion 82 is suspended over the bowl 18 , it is preferred that the edge 84 terminates at the plane of the side wall to maximize the usable area of the bowl 18 . Referring to FIGS. 6 and 7, the projection 74 of the cutting board and the recess 64 of the lid collectively form a releasable coupling 80 that secures the cutting board 70 to the lid 32 to limit the relative movement between the cutting board 70 and lid 32 . The nesting or mating of the projection 74 within the recess 64 results in the corresponding peripheral edges 65 , 75 , respectively, interacting to limit the movement of the cutting board relative to the lid in two dimensions defined by the arrows A and B in FIG. 2 . Arrow B corresponds to the most common direction that a user of the cutting board will apply a force to the cutting board. The receipt of the ribs 66 within the grooves also interact to provide an additional structure that limits the relative movement of the cutting board in the direction of the arrow B. To mount the cutting board 70 to the lid 32 , the cutting board is oriented such that the lower surface 72 of the cutting board 70 faces towards upper surface 62 of the lid 32 and aligns the cutting board 70 such that the projection 74 extending from the lower surface of the cutting board 70 is received within the recess 64 on the upper surface 62 of the lid 32 . Since the grooves 76 and the projection 74 of the cutting board 70 are spaced such that they correspond to the ribs 66 within the recess 64 of the lid 32 , the ribs 66 will be received within the grooves 76 when the cutting board is nested or mated with the lid. The complementary grooves 76 and ribs 66 will also locate and align the cutting board 70 relative to the lid 32 . It is preferred, but not necessary, that the grooves 76 extend all the way across the projection 74 in contrast to the ribs 66 that do not extend all way across the recess 64 . The extra length associated with the grooves 76 will aid the user in laterally aligning the projection 74 of the cutting board with respect to the recess 64 and the lid 32 . As is seen in FIGS. 6 and 7, when the cutting board 70 is nested or mated with the recess 64 of the lid 32 , the ribs 66 of the lid 32 are received within the grooves 76 such that the apex of the ribs 66 are closely adjacent to or touch the bottom of the corresponding grooves 76 . Also, the peripheral edge of the projection 74 is closely adjacent to or in abutting relationship with the peripheral edge of the recess 64 . The close relationship or abutting contact between peripheral edges 65 , 75 of the projection and recess along and in combination with the close relationship or abutting contact between the ribs and the corresponding grooves defined a releasable coupling that limits the relative movement of the cutting board in the plane of the upper surface of the lid. While it is preferred to use both the peripheral edges of the projection and recess and the complementary ribs and grooves to form the releasable coupling, it is not necessary to use both. While it is preferred that there be little gap between the peripheral edges 65 , 75 when the projection 74 is inserted with the recess 64 to thereby minimize the amount of “play” or limited relative movement between the cutting board 70 and the lid 32 , it is not necessary to prevent all relative movement. Other types of releasable coupling can also be used to limit the relative movement of the cutting board and the lid. For example, the cutting board could be provided with a series of point-like discrete projections, such as a stud, in combination with a corresponding opening, instead of the ribs and grooves. FIGS. 8-10 illustrate a second embodiment of a cutting board connected to the lid by a releasable coupling according to the invention. The second embodiment comprises a cutting board 90 having a planar lower surface 92 , which does not include a projection like the first embodiment. Instead, multiple feet 94 are located on the lower surface 92 of the cutting board 90 . Preferably, there are four feet, with each foot being located corresponding to a corner of the recess 64 , although more or less feet can be used. The feet 94 are can made from rubber and have a frusto-conical shape with a lower end 96 and upper end 98 , which are connected by a tapered peripheral side wall 100 . The angle of the taper is preferably complementary to the angle of the bevel 65 of the recess 64 so that the peripheral side wall 100 contacts the bevel 65 for most of its length. The lower end 96 is countersunk to define a shoulder 102 and an fastener opening 104 . A fastener, such as screw 106 , mounts the foot to the cutting board. The head of the screw 106 abuts the shoulder 102 and the threaded end of the screw extends through the fastener opening 104 and is threaded into the cutting board through the lower surface 92 . When the cutting board 90 with the feet 94 is coupled to the lid 32 , the feet 94 are located at each corner of the recess 64 . The peripheral side wall 100 of each foot preferably contacts the corresponding portion of the bevel 65 . The multi-point contact with the bevel 65 prevents the cutting board from being moved laterally. The feet 94 and the corresponding portion of the bevel 65 of the recess 64 form a releasable coupling. The feet preferably have height such that the lower surface 92 of the cutting board 92 just makes contact with, or is slightly above, the upper surface of the lid 32 and the lower end 96 of the feet contact the bottom of the recess 64 . The contact of the bottom of the recess 64 by the feet provides another interference coupling, in the form of a frictional interference, between the feet 94 and the lid 32 to retard the lateral movement of the cutting board and lid. While the invention has been specifically described in connection with certain specific embodiments thereof, it is to be understood that this is by way of illustration and not of limitation, and the scope of the appended claims should be construed as broadly as the prior art will permit. For example, although the preferred sink configuration is a double-bowl sink, the in-sink dishwasher can also be used in a single-bowl sink.

1a

BACKGROUND OF THE INVENTION The present invention relates generally to microcatheters used in the field of interventional radiology. More particularly, this invention pertains to microcatheters used in endovascular procedures for diagnostic imaging and therapy of vascular pathology. Since the 1980's, microcatheter technology has advanced to become commonplace in the treatment of vascular lesions of the central nervous system. Microcatheters have been used to treat cerebral aneurysms, fistulas, and arterial venous malformations, for example, by occluding the parent vessel or the pathologic vascular abnormality through an endovascular approach, using selective deposition of coils, particles, or liquid adhesives. The microcatheter can also be used to deliver chemotherapeutic agents to spinal, head and neck, or intracranial malignancies. Microcatheters are used as well to deliver agents to open occluded vasculature, including agents to dissolve clots. Balloon microcatheters are used to open vessels narrowed due to atherosclerosis. As used in the prior art, a microcatheter is advanced from a femoral puncture through the lumen of a guiding catheter which terminates in a carotid or vertebral artery. The microcatheter is advanced beyond the guiding catheter using one of two known techniques. One such prior art technique is directing a guide wire through the lumen of the microcatheter which has varying degrees of tip-shape, torqueability, stiffness and external coating. A second prior art method is a flow-directed technique in which the microcatheter is extremely flexible and is carried by blood flow to the lesion, assisted by of injections of saline or contrast media through the flow directed microcatheter. Each of the primary conventional methodologies for delivering a microcatheter has drawbacks. The guidewire directed microcatheter involves the risk of puncturing a vessel or aneurysm, which can have devastating hemorrhagic consequences intracranially. With the flow-directed microcatheter, it is frequently difficult to make precise turns and select individual vessels when complex vascular anatomy is encountered. A guidewire cannot be used in the flow-directed microcatheter because of the suppleness of the microcatheter and the significant possibilities of puncturing the wall of the microcatheter with a stiff guidewire. This also prohibits the delivery of coils (used to assist in occlusion) through a flow-directed microcatheter. Thus, only liquid adhesive or tiny particles can be injected through the flow-directed variety of microcatheter for vascular occlusion, the tiny particles usually of insufficient size to achieve the desired vascular occlusion. Conversely, the guide-wire directed microcatheter often times cannot be pushed from the groin over a guidewire through multiple turns in branching intracranial vascularity to reach the desired vessel. In one prior art attempt at improvement of these techniques, a method has been developed to incorporate a balloon into the tip of a microcatheter to allow the blood flow to carry the distended balloon distally to the desired target vessel. The disadvantage with the balloon technology is that two lumens are required, one for the lumen to deliver the embolic agent, and the second to inflate and deflate the balloon. Alternatively, a calibrated leak balloon can be incorporated in the tip of the microcatheter. This, however, does not allow for directionality and cannot be used with a guidewire. Thus, it is an object of the present invention to achieve catheterization of high-flow vascular lesions in the head, or elsewhere, using flow-directed as well as guidewire technology and permitting delivery of all embolic agents. SUMMARY OF THE INVENTION A microcatheter is provided with an auxiliary guide structure which is shaped and which functions like a parachute. The rectangular, trapezoid, or triangular parachute is joined to the catheter by proximal and distal control strings attached to the corners of the parachute. The control strings pass through distal and proximal apertures in the catheter wall and enter string channels formed in the catheter wall. The control strings then extend through the channels back to the proximal or hub end of the microcatheter where they again exit the catheter so that they can be manipulated by the radiologist. The distal control string apertures are proximate the catheter tip. The proximal control string apertures are spaced away from the distal apertures. The distal and proximal apertures are separated by a distance which is less than the diameter of the catheter. The catheter is advanced through a guide catheter to the vasculature by retracting the control strings so that the parachute is positioned flat against the exterior wall of the catheter. The position of the microcatheter is tracked by radiographically monitoring a radio-opaque marker band around the catheter tip. The microcatheter is advanced to the target area using the parachute which is initially deployed by advancing the control strings distally. The catheter can then be further advanced by the action of blood or injected fluid flow against the parachute. Precision direction control is facilitated by manipulation of the distal and proximal control strings from the hub end of the microcatheter. When the procedure is concluded, the parachute is retracted to its non-deployed position and the microcatheter is withdrawn. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1a is a side view of a first embodiment of the microcatheter of this invention, showing four control strings, cables, or wires exiting from the proximal segment of the microcatheter just before attachment to the plastic hub FIG. 1b is a side view of a second embodiment of the microcatheter in which the control strings are incorporated into the proximal portion of the hub proper. FIG. 2a is a cross-sectional end view of a middle segment of the microcatheter showing the string channels through the walls of the microcatheter. FIG. 2b is a cutaway side view of the microcatheter middle segment of FIG. 2a, with the control strings arranged in a linear or straight pattern within the catheter wall. FIG. 2c is a cutaway side view of a middle section of the microcatheter segment of FIG. 2a, but with the strings arranged in a spiral pattern within the catheter wall. FIG. 3a is a side view of the distal segment of the microcatheter and tip, showing a radio-opaque marker band located proximal to the tip orifice FIG. 3b a cross-sectional end view of the tip of the microcatheter, showing the distal control strings exiting from string channels arranged in opposed positions at points near the transverse midline of the catheter wall. FIG. 3c is a cross-sectional of the distal segment of the microcatheter showing the proximal control strings exiting from string channels arranged in opposed positions at points near the transverse midline of the catheter wall. FIG. 3d is a plan view of the microcatheter of FIGS. 3a. b. and c showing the parachute in its non-deployed position adjacent the exterior wall of the microcatheter, with the distal control strings coursing to the opposite side of the microcatheter tip and towards their respective channel apertures, and the proximal control strings coursing to the proximal string channel apertures. FIG. 4 is a plan view of the distal segment of the microcatheter and tip with the parachute in a deployed position located distally of or above the microcatheter tip, attached to two distal control strings and two proximal control strings. FIG. 5a is a plan view of a first embodiment of the parachute structure of the microcatheter of the present invention, showing each of the distal and proximal strings attached to a corresponding corner of a rectangular parachute. FIG. 5b is a plan view of a second embodiment of the parachute structure of the microcatheter of the present invention in which two control strings have been used, one distal string exiting and returning through the distal channel apertures, and the proximal string exiting and returning through the proximal channel apertures, each of the strings coursing through the width end margins of a rectangular parachute, respectively. FIG. 5c is a plan view of a third embodiment of the parachute structure of the microcatheter of the present invention, illustrating a cross configuration of two control strings used with a rectangular parachute, with each control string coursing from a distal string channel aperture to an opposite proximal string channel aperture. FIG. 6a is plan view of the distal segment of the microcatheter and tip, with a triangular shaped parachute in its non-deployed position proximate the exterior side wall of the distal and tip segment of the microcatheter. FIG. 6b is a first embodiment of a triangular shaped parachute structure with a single proximal control string and two distal control strings attached to corresponding corners of the parachute. FIG. 6c is a second embodiment of a triangular shaped parachute structure with a single proximal string attached to one corner of the parachute, and a single distal string attached along the distal margin of the parachute. FIG. 7a is a plan view of the microcatheter of the present invention positioned inside a vascular structure with the parachute in its non-deployed or parked position. FIG. 7b is an enlarged plan view of the distal segment and tip of the microcatheter as shown in FIG. 7a. FIG. 7c is an enlarged side view of the distal segment and tip of the microcatheter as shown in FIG. 7a. FIG. 8a is a plan view of the microcatheter of the present invention as it is guided through a vascular structure with the parachute in its deployed position. FIG. 8b is an enlarged plan view of the distal segment and tip of the microcatheter as shown in FIG. 8a. FIG. 8c is an enlarged side view of the distal segment and tip of the microcatheter as shown in FIG. 8a. DESCRIPTION OF THE PREFERRED EMBODIMENTS Looking at FIGS. 1a and 8a, the microcatheter 10 has a hub portion 11 joined to catheter portion 12. In its preferred embodiment for use in interventional radiology, the catheter portion 12 is a 3.5 French or smaller diameter catheter with an internal lumen of 0.026 to 0.010 inches. As seen in FIGS. 1a, 2b, 3a, and 8a, the catheter portion 12 can be viewed as having a proximal segment 13 near the hub 11, followed by a middle segment 14, and a distal segment 15 which terminates in a tip 16. The over all length of the catheter portion 12 will typically measure 150 cm, but it can be made in varying sizes between 60 cm and 175 cm in length. The catheter portion 12 is made of any of a number of plastic materials, including polyethylene, polyurethane, may be coated internally or externally with a hydrophilic coating, and may contain metal braiding inherent to its walls. Preferably, the distal segment 15 of the catheter will include a radio-opaque marker band 27 (FIG. 3a) near the tip 16 so that the radiologist can accurately track the movement and position of the catheter tip 16. In accordance with one of the novel features of the microcatheter 10, a parachute structure 20 is attached to the distal segment 15 of the catheter 12 by one or more distal control strings 21 and one or more proximal control strings 22. The strings 21, 22 can be strings, wires, or cables made of a flexible, high-tensile strength biocompatible material. They may be radioopaque. The parachute structure 20 will preferably have either a rectangular shape (FIGS. 5a-c) or a triangular shape (FIG. 6a-c). The hub portion 11 of the microcatheter 10 remains outside the body when the microcatheter 10 is used. The hub 11 is also made of plastic and has an internal geometry in the shape of a funnel such that the input side of the hub 11 is easily connected to a standard 2 or 3-way stopcock (not shown). The output side of the hub 11 (the narrow end of the funnel) connects to the small internal lumen of the catheter portion 12. Looking at FIG. 2a, the cylindrical wall 17 of the catheter 12 is manufactured so that four small diameter string channels 18 are formed within the wall 17 and traverse the length of the catheter 12 either in a straight (FIG. 2b) or spiral (FIG. 2c) configuration. The string channels 18 must be large enough to slidably accommodate the distal and proximal control strings 21, 22 and small enough so that they do not significantly alter the strength, trackability, or stiffness of the inherent microcatheter. When the triangular form of the parachute 20 is used, only 3 straight or spiral channels 18 are necessary. Within each of the four channels 18 are the proximal and distal control strings 21, 22. The control strings 21, 22 enter their corresponding channels 18 through openings in the catheter wall 17 near or through the base of the hub 11 (FIGS. 1a and 1b.) The strings 21, 22 then extend through their corresponding channels 18 the length of the catheter 12 to the distal segment 15 of the catheter. The distal control strings 21 exit their corresponding channels 18 through distal string apertures 23 through the catheter wall 17, close to the tip 16. As seen on FIG. 3b, the distal string apertures 23 are formed at opposed positions that are near but slightly separated from the transverse midline 25 of the catheter tip 16. As best seen on FIGS. 3c and 3d, the proximal control strings 22 exit from their channels 18 through proximal string apertures 24 that are positioned away from the distal string apertures 23. The proximal string apertures 24 are located through the catheter wall 17 in positions opposite of the distal string apertures 23, separated slightly away from the midline 25. Thus, the linear distance between the respective distal and proximal string apertures 23, 24 is slightly less than the diameter of the catheter 12. In the preferred embodiments of FIGS. 5a-c, the distal and proximal control strings 21, 22 are attached to the corners of a rectangular parachute 20 made of a radio-opaque, biocompatible material, such as silicon, that retains its shape when exposed to blood at 37° centigrade. Alternatively, the parachute 20 may be triangular in shape (FIGS. 6a-c) with the proximal corner 26 aligned with the long axis of the catheter 12 when the parachute 20 is in a parked or non-deployed position as shown on FIG. 7. The control strings 21, 22 may be attached to the parachute 20 in any of a number of configurations, some of which are illustrated in FIGS. 5a-c and 6a-c. For example, as seen in FIG. 5a, the four control strings 21, 22 can be attached to the four corners of the parachute 20. In FIG. 5b, two control strings are actually one string, with a proximal string 22 attached along the proximal marginal edge of the parachute 20, and the distal control string 21 attached along the more distal marginal edge of the parachute 20. Or, as illustrated in FIG. 5c, the distal and proximal control strings 21, 22 can be oriented in a criss-cross configuration, with the distal string 21 extending from a distal corner of the parachute 20 and, embedded into the parachute 20, connected to the diagonally opposite proximate corner of the parachute 20. The proximal string 22 is then attached in an opposite diagonal configuration. When employing a triangular shaped parachute 20 as in FIGS. 6a-c, the two distal strings 21 are attached to the distal corners of the parachute 20 (FIG. 6b). Alternatively, a single distal string 21 can be attached along the distal margin of the parachute, as seen in FIG. 6c. The control strings 21, 22 must be attached to the parachute 20 in a conventional manner such that there would be no possibility of tearing at the junction point. As seen on FIG. 3d and FIG. 8b, the proximal width of the deployed parachute 20 should be slightly less than the width of the catheter 12. The length of the parachute 20 is approximately 3 mm. When beginning use of the parachute microcatheter 10, the non-deployed parachute 20 will be "parked" near the exterior surface of wall 17 at the distal segment 15 so that the catheter 10 and parachute 20 combination will have a low profile. This is done by having the radiologist manipulate the hub end of the control strings 21, 22 (FIGS. 1a-b). The catheter 12 and parachute 20 will then be advanced through a "Y" connector connected to a guiding catheter (not shown), exiting the vessel in which the tip of the guiding catheter resides. Once the catheter 12 is recognized to have exited the guiding catheter and is identified by the radio-opaque marker band 27 in the tip of the microcatheter, the control strings 21, 22 are then advanced distally by the radiologist so that the parachute 20 is deployed, as shown on FIG. 8. The parachute 20 is opened by the flowing blood and/or injection of saline or contrast through the tip 16 of the catheter 12. Once the parachute 20 is opened, this will pull the catheter 12 into the cerebral vasculature. Movement of the catheter can be directed to the appropriate vasculature by manipulation of the control strings 21, 22 just as a target skydiver will control his or her parachute. Alternatively, if a high-flow situation is not present, the parachute 20 can be used to access the largest intracranial vessels then can be withdrawn to resume its parked position flush with the tip 16. Then a guide wire can be employed through the lumen of the catheter 12. Because of the location of the control string apertures 23, 24 the strings will not obstruct the tip 16 and will assume a position along the outer wall 17. When the procedure is complete, the radiologist will then manipulate the control strings 21, 22 in a proximal direction, causing the parachute to once again assume the parked position. The catheter 12 can then be withdrawn. The embodiments of the microcatheter described herein are shown with three or four control strings. However, more control strings could be used without departing from the scope of the invention. Thus, although there have been described particular embodiments of the present invention of a new and useful "Microcatheter with Auxiliary Parachute Guide Structure", it is not intended that such references be construed as limitations upon the scope of this invention except as set forth in the following claims. Further, although there have been described certain dimensions used in the preferred embodiment, it is not intended that such dimensions be construed as limitations upon the scope of this invention except as set forth in the following claims.

1a

BACKGROUND OF THE INVENTION [0001] 1. Technical Field [0002] The present invention relates to a cleaning tool. [0003] 2. Description of Related Art [0004] Currently, there are many cleaning tools with various structural forms. For instance, a Chinese Patent No. CN201020195246.6 discloses a “mop bucket and its mop”. In this technical scheme, the mop bucket is provided with a washing part and a drying part, wherein the drying part is equipped with a drying basket configured on the installation seat which is higher than the bottom of the bucket, and the washing part is equipped with a rotatable washing rack which is configured at the lower part of the washing part. When drying the mop, the user shall put the hand pressing type mop in the drying basket, and then depress the mop rod to drive the mop head and the drying basket to rotate, thus realizing centrifugal drying. When washing the mop, the user shall put the hand pressing type mop on the cleaning rack and then depress the mop rod to drive the mop head to rotate, which further drives the water in the bucket to rotate, thus the mop head is cleaned. During drying, when depressing the mop rod, the water-contained mop head can be dried rapidly since the rotation resistance is low. However, during washing, the mop head is put in the washing part, so the wiping object on the mop head will contact with the bucket wall. Moreover, it is required to drive the water in the washing bucket to rotate with a high resistance. Therefore, washing the mop by depressing the mop rod requires a lot of labor. BRIEF SUMMARY OF THE INVENTION [0005] One object of the present invention is to provide a labor-saving cleaning tool easy for drying and washing operations. [0006] To realize the object above of the present invention, the following technical scheme is adopted: [0007] A cleaning tool according to one embodiment includes a mop bucket and a mop. The lower end of the mop rod is provided with a mop head with a wiping object, and the mop rod includes an inner rod and an outer rod. The inner rod has a lower end that connects with the mop head, and the inner and outer rods are sleeved and joint with each other. The tool also includes a drive mechanism, used to convert the telescoping motion of the mop rod to the rotational motion of the mop head, is mounted between the inner rod and the outer rod. A rotatable drying basket is accommodated in the mop bucket. During drying, the mop head is put in the drying basket and the drive mechanism drives the mop head and the drying basket to rotate unidirectionally. The mop bucket is provided with a rotatable washing head on which the mop head is put during washing. The drive mechanism drives the mop head to rotate unidirectionally. In accordance with the invention, the drive mechanism is a variable speed drive mechanism; during drying, the mop rod is depressed and the variable speed drive mechanism drives the mop head to rotate at a first rotation speed. During washing, the mop rod is depressed at the same speed and the variable speed drive mechanism drives the mop head to rotate at a second rotation speed, wherein the first rotation speed is higher than the second rotation speed. [0008] The advantages of the present invention are as follows: since the mop head of the cleaning tool provided by the present invention can get different rotation speeds under the drying condition with a lower resistance and the washing conditions with a higher resistance, and the first rotation speed is higher than the second rotation speed, the mop of the present invention can rapidly drive the drying basket to realize centrifugal drying. During washing, the mop head is washed rotationally at a lower speed, and the washing operation conducted through depressing the mop rod also saves labor. [0009] In the present invention, the variable speed drive mechanism includes a drive mechanism and a control mechanism, wherein the former can convert the telescoping motion of the mop rod to the rotational motion of the mop head and the later can control different output rotation speeds of the mop head under different working conditions to realize high-speed rotational drying and low-speed rotational cleaning simultaneously, thus achieving the labor-saving depression operation of the mop head under both working conditions. [0010] In the present invention, clamping slots capable of rotating relative to other components of the mop head are accommodated in the mop head and clamps fit for the clamping slots are respectively configured on the drying basket and the washing head. During drying, the mop rod is depressed to drive the clamping slots in the mop head to rotate, which drives the clamps in the drying basket to rotate and further drives the drying basket to rotate. [0011] In the present invention, the drive mechanism comprises: a screw rod fixed with the outer rod and a transmission part fixed inside the inner rod, wherein the transmission part is provided with a rotation part in which screw threads fit for the screw rod are set. A unidirectional transmission mechanism is mounted between the rotation part and the transmission part. The drive mechanism can realize the driving of the rotation of the mop head by depressing the mop rod. [0012] In the present invention, the control mechanism comprises: a clamping chassis configured on the lower cover of the mop head, a speed reduction device accommodated in the mop head and a washing head accommodated in the washing head installation seat which is provided with a clamping seat fit for the clamping chassis; wherein the speed reduction device is a planetary gear transmission whose sun gear is connected with the mop rod and integrated with the clamping slots in the mop head, and whose gear ring is accommodated in the mop disk of the mop head, the lower cover of the mop head and the mop head can rotate relative to each other. The working process of the control mechanism is as follows: when drying, the mop rod is depressed to drive the mop head to rotate and the clamping slots in the mop head drives the clamps in the drying basket to rotate, thus realizing centrifugal drying. When washing the mop, the mop rod is depressed, since a clamping chassis is configured on the lower cover of the mop head and a clamping seat fit for the clamping chassis is configured on the washing head installation seat, the lower cover of the mop head and the washing head installation seat can not rotate relative to each other when the clamping chassis is fixed by the clamping seat. At this time, the mop rod drives the sun gear of the planetary gear transmission; the planetary gear drives the gear ring and further drives the mop disk of the mop head to rotate, thus realizing the speed reducing rotation of the mop head to decrease the resistance of the mop head during washing so as to realize labor-saving washing. [0013] In the present invention, the control mechanism comprises: a clamping chassis configured on the mop head, a washing head and speed reduction device accommodated in the washing head installation seat on which a clamping seat fit for the clamping chassis is configured; wherein the speed reduction device is a planetary gear transmission whose sun gear is connected with the washing head, and whose gear ring is accommodated in the clamping seat. The working process of the control mechanism is as follows: when drying, the mop rod is depressed to drive the mop head to rotate and the clamping slots in the mop head drives the clamps in the drying basket to rotate, thus realizing centrifugal drying. When washing the mop, the mop rod is depressed, and the clamping chassis on the mop head locks the clamping seat on the washing head installation seat so that the mop disk of the mop head and the washing head installation seat can not rotate relative to each other. At this time, the mop rod drives the washing head which drives the sun gear of the planetary gear transmission, the planetary gear drives the gear ring and further drives the rotatable clamping seat and the mop head to rotate, thus realizing the speed reducing rotation of the mop head to decrease the resistance of the mop head during washing so as to realize labor-saving washing. [0014] In the present invention, the control mechanism comprises: a mop rod including three sections of rod parts, wherein a group of drive mechanisms are configured between the upper rod and the middle rod, a first control switch controls the relative rotation and positioning between the upper rod and the middle rod, another group of drive mechanisms are configured between the middle rod and the lower rod, a second control switch controls the relative rotation and positioning between the middle rod and the lower rod, and the screw rods of the two groups of drive mechanisms have different screw pitch. The working process of the control mechanism is as follows: when dehydration, either the first control switch or the second control switch is turned on to make the drive mechanism with shorter screw pitch in the two screw rods to work, at this time, the mop rod is depressed to enable the drive mechanism to output a higher rotation speed, thus realizing high-speed drying. When washing the mop, the other control switch is turned on to make the drive mechanism with longer screw pitch in the two screw rods to work, at this time, the mop rod is depressed to enable the drive mechanism to output a lower rotation speed, thus realizing low-speed rotational washing. It can also simultaneously accomplish the high-speed rotational dehydration and low-speed rotational washing, thus saving labor in depression operation of the mop rod under both working conditions. [0015] In the present invention, the unidirectional transmission mechanism comprises: a transmission gear configured at the bottom of the rotation part, and another transmission gear configured at the bottom of the inner side of the transmission part, wherein the two transmission gears are provided with a mating surface and a sliding surface fit for each other, and the rotation part can move up and down relative to the transmission part; when the rotation part rotates in one direction to let the mating surfaces of the two transmission gear support against each other, a unidirectional transmission is formed; when the rotation part rotates in another direction to let the sliding surfaces of the two transmission gear support against each other, the rotation part moves relative to the transmission part and forms an idle transmission. It can realize unidirectional transmission function. [0016] In the present invention, the unidirectional transmission mechanism comprises: a unidirectional bearing configured between the transmission part and the rotation part, wherein, when the rotation direction of the rotation part is the locking direction of the unidirectional bearing, a unidirectional transmission is formed between the rotation part and the transmission part; when the rotation direction of the rotation part is the free rotation direction of the unidirectional bearing, an idle transmission is formed between the rotation part and the transmission part. It can also realize unidirectional transmission function. [0017] In the present invention, the drying basket and washing head are configured in the same mop bucket. Of course, the drying basket and washing head in the present invention can be configured in different mop buckets respectively. Both of the two structures above can realize the object of the present invention. [0018] In the present invention, a ratchet is configured on the upper part of the clamping slots, and another ratchet fit for the ratchet is configured on the unidirectional control sheet sleeved on the upper part of the clamping slots. The lower cover of the mop head restricts the rotation of the unidirectional control sheet. Carry and rotate the mop rod manually, when the rotation direction is the direction in which the two ratchets are supported against each other, the wiping object on the mop head can be unfolded by means of the interaction between the two ratchets. [0019] In the present invention, a ratchet is configured on the upper part of the clamping slots, and another ratchet fit for the ratchet is configured on the unidirectional control sheet sleeved on the upper part of the clamping slots. The mop disk of the mop head restricts the rotation of the unidirectional control sheet. It can also unfold the wiping object on the mop head by means of the interaction between the two ratchets. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0020] FIG. 1 is the section view of Embodiment 1 of the present invention. [0021] FIG. 2 is the exploded view of the components near the dehydration basket in Embodiment 1 of the present invention. [0022] FIG. 3 is the perspective view of Embodiment 1 of the present invention. [0023] FIG. 4 is the exploded view of the components near the mop head in Embodiment 1 of the present invention. [0024] FIG. 5 is the schematic view of the structure of the mop head part in Embodiment 1 in the present invention. [0025] FIG. 6 is the schematic view of the structure of the mop rod in Embodiment 1 of the present invention. [0026] FIG. 7 is the section view of Embodiment 2 of the present invention. [0027] FIG. 8 is the exploded view of the components near the washing head in Embodiment 2 of the present invention. [0028] FIG. 9 is the perspective view of Embodiment 2 of the present invention. [0029] FIG. 10 is the exploded view of the components near the mop head in Embodiment 2 of the present invention. [0030] FIG. 11 is the schematic view of the mop head part in Embodiment 2 of the present invention. [0031] FIG. 12 is the perspective view of Embodiment 3 of the present invention. [0032] FIG. 13 is the partial section view of the mop rod in Embodiment 3 of the present invention. [0033] FIG. 14 is the exploded view of a unidirectional transmission mechanism of the present invention. [0034] FIG. 15 is the section view of a unidirectional transmission mechanism of the present invention. [0035] FIG. 16 is the exploded view of another unidirectional transmission mechanism of the present invention. [0036] FIG. 17 is the section view of another unidirectional transmission mechanism of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0037] According to FIGS. 1-6 , FIG. 13 and FIG. 14 , a cleaning tool in one exemplary embodiment includes a mop bucket 1 and a mop. The lower end of the mop rod is provided with a mop head 2 with a wiping object. The mop rod includes an inner rod 3 and an outer rod 4 . The inner rod 3 , whose lower end connects with the mop head 2 , and the outer rod are sleeved and joint with each other. The tool includes a drive mechanism, used to convert the telescoping motion of the mop rod to the rotation motion of the mop head, is configured between the inner rod and the outer rod. A rotatable drying basket 5 is accommodated in the mop bucket and during drying, the mop head 2 is put in the drying basket 5 and the drive mechanism drives the mop head and the drying basket to rotate unidirectionally. A rotatable washing head 6 is accommodated in the mop bucket. During washing, the mop head 2 is put on the washing head 6 and the drive mechanism drives the mop head to rotate unidirectionally. The drive mechanism is a variable speed drive mechanism. During drying, the mop rod is depressed and the variable speed drive mechanism drives the mop head to rotate at the first rotation speed. During washing, the mop rod is depressed at the same speed, the variable drive mechanism drives the mop head to rotate at the second rotation speed, wherein the first rotation speed is higher than the second rotation speed. [0038] In the embodiment, the variable speed drive mechanism comprises a drive mechanism and a control mechanism. The drive mechanism comprises a screw rod 7 fixed with the outer rod 4 , and a transmission part 8 fixed inside the inner rod, wherein the transmission part 8 is provided with a rotation part 9 in which screw threads 10 fit for the screw rod are set. A unidirectional transmission mechanism is mounted between the rotation part and the transmission part. [0039] In the embodiment, the control mechanism comprises: a clamping chassis 12 configured on the lower cover 11 of the mop head, a speed reduction device accommodated in the mop head and a washing head 6 accommodated in the washing head installation seat 13 which is provided with a clamping seat 14 fit for the clamping chassis; wherein the speed reduction device is a planetary gear transmission whose sun gear 15 is connected with the mop rod and integrated with the clamping slots 16 in the mop head, and whose gear ring 17 is accommodated in the mop disk 2 - 1 of the mop head 2 , the lower cover 11 of the mop head and the mop head can rotate relative to each other. [0040] In the embodiment, clamping slots 16 capable of rotating relative to other components of the mop head are accommodated in the mop head, and two clamps 18 - 1 and 18 - 2 fit for the clamping slots are respectively configured on the drying basket and the washing head. A ratchet 19 is configured on the upper part of the clamping slots and another ratchet 21 fit for the ratchet 19 is configured on the unidirectional control sheet 20 sleeved on the upper part of the clamping slots. The lower cover of the mop head restricts the rotation of the unidirectional control sheet. When the rotation direction is the direction in which the two ratchets above are supported against each other, the wiping object on the mop head can be unfolded by means of the interaction between the two ratchets. [0041] The working process of the embodiment is as follows: when drying, the mop rod is depressed to drive the mop head to rotate and the clamping slots in the mop head drive the clamps in the drying basket to rotate, thus realizing centrifugal drying. When washing the mop, the mop rod is depressed, since a clamping chassis is configured on the lower cover of the mop head and a clamping seat fit for the clamping chassis is configured on the washing head installation seat, the lower cover of the mop head and the washing head installation seat can not rotate relative to each other when the clamping chassis is fixed by the clamping seat. At this time, the mop rod drives the sun gear of the planetary gear transmission, and the planetary gear drives the gear ring and further drives the mop disk of the mop head to rotate, thus realizing the speed reducing rotation of the mop head to decrease the resistance of the mop head during washing so as to realize labor-saving washing. [0042] Since the mop head of the cleaning tool provided by the embodiment can get different rotation speeds under the drying conditions with a lower resistance and the washing conditions with a higher resistance to realize the high-speed rotational drying and low-speed rotational cleaning simultaneously, both the dehydration and cleaning of the mop can save labor. [0043] FIGS. 7-11 show Embodiment 2 of the present invention. The drive mechanism in the embodiment is the same with that in Embodiment 1. The control mechanism of the embodiment comprises: a clamping chassis 22 configured on the mop head 2 , a washing head 6 and a speed reduction device accommodated in the washing head installation seat 13 on which a clamping seat 23 fit for the clamping chassis 22 is configured; wherein the speed reduction device is a planetary gear transmission whose sun gear 24 is connected with the washing head, and whose gear ring 25 is accommodated in the clamping seat 23 . Other components in the embodiment are the same with those in Embodiment 1, which can also realize the object of the present invention. [0044] The working process of the embodiment is as follows: when drying, the mop rod is depressed to drive the mop head to rotate and the clamping slots in the mop head drives the clamps in the dehydration basket to rotate, thus realizing centrifugal dehydration. When washing the mop, the mop rod is depressed; the clamping chassis on the mop head locks the clamping seat on the washing head installation seat so that the mop disk of the mop head and the washing head installation seat can not rotate relative to each other. At this time, the mop rod drives the washing head which further drives the sun gear of the planetary gear transmission, the planetary gear drives the gear ring which further drives the rotatable clamping seat and the mop head to rotate, thus realizing the speed reducing rotation of the mop head to decrease the resistance of the mop head during washing so as to realize labor-saving washing. [0045] FIGS. 12 and 13 show Embodiment 3 of the present invention. In the embodiment, the control mechanism comprises: a mop rod including three sections of rod parts, wherein a group of drive mechanisms 26 are configured between the upper rod and the middle rod, a first control switch 27 controls the relative rotation and positioning between the upper rod and the middle rod, another group of drive mechanisms 28 are configured between the middle rod and the lower rod, a second control switch 29 controls the relative rotation and positioning between the middle rod and the lower rod, and the screw rods 7 - 2 and 7 - 3 of the two groups of drive mechanisms have different screw pitch. [0046] The working process of the embodiment is as follows: when drying, either the first control switch or the second control switch is turned on to make the drive mechanism with shorter screw pitch in the two screw rods to work, at this time, the mop rod is depressed to enable the drive mechanism to output a higher rotation speed, thus realizing high-speed drying. When washing the mop, the other control switch is turned on to make the drive mechanism with longer screw pitch in the two screw rods to work, at this time, the mop rod is depressed to enable the drive mechanism to output a lower rotation speed, thus realizing low-speed rotational washing. The embodiment can also simultaneously accomplish the high-speed rotational drying and low-speed rotational washing, thus saving labor in depression operation of the mop rod under both working conditions. [0047] FIGS. 14 and 15 show a unidirectional transmission mechanism according to the present invention. In the embodiment, the unidirectional transmission mechanism comprises: a transmission gear 30 configured at the bottom of the rotation part 9 , and another transmission gear 31 configured at the bottom of the inner side of the transmission part 8 , wherein the two transmission gears are provided with a mating surface and a sliding surface fit for each other, and the rotation part can move up and down relative to the transmission part; when the rotation part rotates in one direction to let the mating surfaces of the two transmission gear support against each other, a unidirectional transmission is formed; when the rotation part rotates in another direction to let the sliding surfaces of the two transmission gear support against each other, the rotation part moves relative to the transmission part and forms an idle transmission. It can realize unidirectional transmission function. [0048] FIGS. 16 and 17 show another unidirectional transmission mechanism according to the present invention. In the present invention, the unidirectional transmission mechanism comprises: a unidirectional bearing 32 configured between the transmission part 8 and the rotation part 9 , wherein, when the rotation direction of the rotation part is the locking direction of the unidirectional bearing, a unidirectional transmission is formed between the rotation part and the transmission part; when the rotation direction of the rotation part is the free rotation direction of the unidirectional bearing, an idle transmission is formed between the rotation part and the transmission part. It can also realize unidirectional transmission function. [0049] In the present invention, the dehydration basket and washing head are configured in the same mop bucket. Of course, the drying basket and washing head in the present invention can be configured in different mop buckets respectively. Both of the two structures above can realize the object of the present invention. [0050] The embodiments above are only the individual cases for application of the present invention. Any such change and combination of the embodiments according to the spirit of the present invention should be covered in the scope of protection of the present invention.

1a

CROSS-REFERENCES TO RELATED APPLICATIONS The essential features of the game board are the subject of copending design patent application Ser. No. 722,120, filed Sept. 10, 1976. BACKGROUND OF THE INVENTION A. Field of the Invention The invention relates to a game apparatus used to simulate the interaction of spacecraft of different stellar civilizations operating in an imaginary solar system. The direction and velocities of the spacecraft take into account the effects of gravity in their simulated travels with the spacecraft having their velocity and direction affected by their interaction with the planets and star of the solar system. B. Prior Art Space travel games are well known and there have been numerous patents issued to such games, including U.S. Pat. Nos. 1,538,134; 3,037,773; 3,099,451; 3,223,420; 3,806,126; and 4,010,954. However, none of these prior art games appear to utilize the interactive concepts contained in the present invention. With regard to the specific board configuration, U.S. Pat. No. 3,917,272 discloses the use of hexagonal cells, but not in the specific configuration of the present invention. As indicated above, the essential features thereof are the subject of the aforementioned copending design patent application. With regard to the game pieces and the two different velocity indicator embodiments, none of the aforementioned prior art references appear to teach or suggest elements having all of the features of those of the present invention. SUMMARY OF THE INVENTION An object of the invention is to provide an interesting and stimulating game apparatus comprising a game board and game pieces or markers used to stimulate the interaction of spacecraft of different stellar civilizations with each other and with the planets and star of a specific solar system. Another object is to provide a game apparatus wherein the effect of gravity and centrifugal and centripetal acceleration and deceleration on spacecraft is taken into account in the game apparatus. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates the game board according to the present invention. FIG. 2A illustrates one embodiment of the game pieces used to represent the alpha, delta, and zeta class spacecraft. FIG. 2B illustrates a cardholder provided to hold the velocity cards used in one embodiment of the present invention. FIG. 2C illustrates the orbit markers provided to symbolize the entry location within the gravity field of a spacecraft initiating a point orbit according to the present invention. FIG. 2D illustrates a second embodiment of the game pieces used to represent the alpha, delta, and zeta class spacecraft. FIG. 3 illustrates the game board with many of the game pieces positioned to facilitate a description of the game rules. FIG. 4A illustrates the interceptor class spacecraft game piece. FIG. 4B illustrates the point piece game playing piece. FIG. 4C illustrates the home space station game piece. FIG. 4D illustrates the planet Chronos game piece. FIG. 4E illustrates the planet Vortex game piece. FIG. 4F illustrates the planet Maelstrom game piece. DESCRIPTION OF THE PREFERRED EMBODIMENTS As illustrated in FIG. 1, the game board comprises a large but fixed number of hexagonal cells 3, 4 surrounding a central element 1, 2 which represents a star in the center of an imaginary solar system. The hexagonal cells vary in size and, as in the case of cells 4, they may not be equilateral hexagons. In addition, also located around central elements 1, 2 are six pentagonal cells 5 arranged equidistant from each other and from the central elements 1 and 2. FIG. 2A illustrates one embodiment of the spacecraft markers used in the present invention. The top 9 as well as the upper sides 10 are painted a solid color, (i.e. blue, green, red, or yellow), to indicate which player the spacecraft game piece belongs to. The bottom front and sides 11 are painted with a different distinguishing color, (i.e. black, silver, or gold), to indicate whether the spacecraft is an alpha, delta, or zeta class spacecraft. The significance of the spacecraft designation will be explained later. On the top 9 of each of these three classes of spacecraft is located a numerical identification 12 used to identify the particular spacecraft. Furthermore, also provided are an additional type of spacecraft game piece, denoted as interceptor class spacecraft and having the same spacecraft structure as shown in FIG. 2A but being painted a solid color corresponding to the colors used for the top 9 and upper sides 10, (i.e. blue, green, red, or yellow), and lacking the identification numbers 12. FIG. 2B illustrates a velocity indicator assembly used in conjunction with the spacecraft illustrated in FIG. 2A. The velocity indicator assembly may be constructed from a piece of sheet material and has an equilateral triangular cross-section 20 when viewed from the side. The assembly has two ledges 21 arranged such that velocity indicator cards 23 and spacecraft indicator cards 22 may be arranged in a convenient fashion on the velocity indicator assembly. The operation of the velocity indicator cards used in conjunction with the spacecraft of FIG. 2A will be explained below. FIG. 2C illustrates the orbit marker pieces with the game providing a corresponding orbit marker for each of the alpha, delta, and zeta class spacecraft. The illustrated marker 30 is in the shape of a coin having an identifying number 31 surrounded by an area 32 having a color corresponding to the class of the corresponding spacecraft (i.e. black, silver, or gold). The remaining areas including the top 33, bottom 35 and side 34 of the marker are painted a color corresponding to that of the particular player to which the marker belongs, (i.e. blue, green, red, or yellow). Accordingly, it is apparent that by suitable choice of colors and numbers, one can provide each of the alpha, delta, and zeta class spacecraft with a corresponding orbit marker. FIG. 2D illustrates another embodiment of the spacecraft game pieces and the velocity indicator pieces used in conjunction thereof. As noted in the drawing, the spacecraft game piece of the second embodiment is similar to that of the first embodiment with the exception being that there is a step 41 cut out of the top 40. This step 41 enables the affixing of a velocity indicator piece 44 by means of a pin 43 constructed to fit into a hole 42. The color scheme of the spacecraft game pieces of this embodiment is identical to that of the game pieces of the first embodiment. The velocity indicator piece 44 is painted either white or purple and has affixed to its top 45, sides 46 and back 47 a number 48 indicative of the simulated velocity of the spacecraft. The operation of this velocity indicator piece in conjunction with the spacecraft pieces of the second embodiment will be explained below. FIG. 4A illustrates the interceptor class spacecraft game piece, The top 140, sides 141 and bottom 142 are painted a solid color (i.e. blue, green, red, or yellow) to indicate to which player a spacecraft belongs. FIG. 4B illustrates the point piece, which is shaped like a coin and has a triangular face. Its top 150, sides 151 and bottom 152 are purple in color. FIG. 4C illustrates a home space station game piece. Its diameter is such that it can be inscribed within one of the game board's regular hexagons (FIG. 1-#3). It is coin shaped, and its top 160, side 161 and bottom 162 are painted a solid color (i.e. blue, green, red or yellow) to indicate to which player it belongs. FIG. 4D illustrates the planet Chronos game piece. Its diameter is such that it can be inscribed within one of the game board's pentagonal cells (FIG. 1-#50). It is coin shaped, and its top 170, side 171 and bottom 172 are pink in color. FIG. 4E illustrates the planet Vortex game piece. Its diameter is such that it can be inscribed within one of the game board's hexagons comprising the second haxagon ring (FIG. 1-#103). It is coin shaped. The dominant color of its top 180, side 181 and bottom 182 is blue, but the top 180 and bottom 182 have artistic renderings of two different portions of a planetary surface, which makes them distinguishable. FIG. 4F illustrates the planet Maelstrom game piece. Its diameter is such that it can be inscribed within one of the game board's hexagons comprising the second hexagon ring (FIG. 1-#101). It is coin shaped. The dominant color of its top 190, side 191 and bottom 192 is purple, but the top 190 and bottom 192 have artistic renderings of two different portions of a planetary surface, which makes them distinguishable. V. Elimination of an Additional Reference to the Neutronium Game Embodiment There are also spacecraft identifier cards and velocity identifier cards used in conjunction with the velocity indicator assembly illustrated in FIG. 2B. The spacecraft identifier cards are of a solid color corresponding to the three classes of spacecraft (i.e. black, silver, or gold) and have an identification number 24 on their front corresponding to the identification numbers on the spacecraft game pieces. The velocity identifier cards are white on their face and purple on their back and have numerals on their front 25 and back corresponding to the simulated velocities of the spacecraft. It is to be noted that the spacecraft game pieces and velocity indicator pieces illustrated in FIG. 2D are used alternatively to the spacecraft game pieces and velocity indicator assembly illustrated in FIGS. 2A and 2B respectively. The only other piece of equipment necessary for the operation of the game would be a pair of ordinary dice. It is, of course, understood that any other device capable of producing a range of numbers with a predetermined frequency distribution could be substituted (i.e.--a wheel of fortune-type spinner or an electronic random number generator). The aforementioned game board and game pieces may be used to simulate the scenario of the game "Galactiad," which scenario has been copyrighted by the present applicant. Essentially, "Galactia" simulates the sportive competition between spacecraft of different stellar civilizations in a similar fashion to that of the present day Olympic competition. The nature of the sport is the competition between fleets of spacecraft maneuvering in a complex gravity field comprising a solar system, consisting of a star and its associated planets, while attempting to score non-destructive laser hits against spacecraft belonging to opposing fleets. Any spacecraft receiving a non-destructive hit from a laser beam is eliminated from the competition. Each team may potentially bring into the competition three different classes of spacecraft having increasing ability to hit other spacecraft with their lasers and avoid being hit themselves. Each team begins the competition using the first and least powerful class of spacecraft with the object of the spacecraft being to start from the home station and complete an orbit of the star and thence to return to the home station, while eliminating as many opponent spacecraft during his travels as possible. A spacecraft which completes the orbit of the star and returns to the home space station gains one point for the team. The accumulated points may be traded in for additional spacecraft including those of higher classes. In regard to the simulation scenario per se of the game "Galactiad" it should be apparent to one having ordinary skill in the art that other scenarios may be devised which would correspond to the game rules for the game constructed in accordance with the present invention. Initially, each player chooses the color of the spacecraft and home space station he will use as well as the playing board corner where he will position his home space station. The location of the home space stations vary and depend on whether two, three or four players are to play the game. FIG. 3 illustrates the positioning of the home stations 51 and their initial spacecraft 52 and 53 for the case of four players. For the case of three players, any one of the home stations 51 and its associated initial spacecraft 52 and 53 may be eliminated. In the case of two players, only the lower two home stations 51 and their associated initial spacecraft 52 and 53 are utilized. However, the initial spacecraft of the lower left home station 51 are rotated sixty degrees in a counterclockwise direction whereas the spacecraft associated with the home space station 51 in the lower righthand corner are rotated sixty degrees in the clockwise direction. The spacecraft 53 represent alpha class spacecraft while the spacecraft 52 represent interceptor class spacecraft. There are two possible methods for determining the winner of a game: (a) The winner is the player who eliminates from the board the spacecraft or home stations of all the other competitors, with the game ending when only his playing pieces remain on the board. A player whose home station is eliminated is removed from the game, even though he may have other spacecraft active on the board. In other words, if the home station is lost, it and all its associated spacecraft are immediately removed from the board. (b) At the beginning of the game, the players agree upon the number of player turns constituting the game. The revolutions of the planet Chronos are used as an indicator to count the number of turns which have transpired and at the completion of the designated number of player turns, the point value of each of the players' playing pieces remaining on the board is determined, with the player having the greatest number of points being declared the winner. For example, the alpha class spacecraft as well as the point pieces may be considered to be worth one point, the delta class and interceptor class spacecraft may be considered to be worth two points, while the zeta class spacecraft may be considered to be worth three points Initially, in the game utilizing the spacecraft game pieces of FIG. 2A in conjunction with the velocity indicator assembly of FIG. 2B, each player positions in his velocity indicator's top slot four black, numbered cards corresponding to the four alpha class spacecraft initially positioned on the playing board. In the velocity indicator's bottom slot, he positions under each black card a white velocity indicator card having the numeral 3. The numeral 3 indicates that the initial velocity of each of the initial spacecraft will be three hexagons per player turn. In the case of the game utilizing the spacecraft game pieces and velocity indicator pieces of FIG. 2D, the white velocity indicator pieces bearing the numeral 3 are attached to each of the four alpha class spacecraft initially positioned on the playing board. The two inner planets, named Maelstrom and Vortex, revolve around the central star, named Serene, in the second and fourth orbit out from the star as indicated by the dotted circles 62 and 61 respectively. This may be illustrated on the game board by means of alternately coloring the hexagons contained in their two orbits. The direction of rotation of the two planets is assumed to be, for example, counterclockwise for Maelstrom and clockwise for Vortex and their allowable location considered to be only the alternate hexagons, (i.e. hexagons 63-74). The initial position of Maelstrom is determined by rolling the dice and the sum of the numbers on the dice indicate the hexagon on which Maelstrom begins its orbiting with hexagon 63 corresponding to the number 1, hexagon 64 corresponding to the number 2, etc. In a similar fashion, the initial location of the planet Vortex is determined with hexagon 75 corresponding to the number 1 and hexagon 76 corresponding to the number 2, etc. The planet named Chronos revolves around the central star using as its orbital positions the six pentagons arranged on the edge of what is considered to be the star's gravity field and illustrated by the dotted circle 60. Chronos's initial orbital position 50 is shown in FIG. 3. A throw of the dice by each player may be used to determine which player is the first to move his spacecraft with play then proceeding clockwise around the board. At the beginning of each player's turn, the player must advance Maelstrom and Vortex one position in their orbits. Both the Maelstrom and Vortex game pieces have two distinctly designed sides such that when the player advances the planet he flips the playing piece over with this feature assisting the player in determining whether or not the planet has been moved. The planet Chronos is placed in its initial position and moved one pentagon in a clockwise direction after every complete orbit of the planet Vortex. The numbers printed on each spacecraft are used to identify the spacecraft and serve no other function. Each spacecraft departing from an initial position on one of the six hexagons contiguous to the home station hexagon has an initial velocity (number of hexagons traversed per player turn) of three hexagons. During each turn, a player must move every alpha, delta, or zeta class spacecraft he has active on the board and must traverse the total number of hexagons indicated as its velocity on the velocity indicator. A player has the option of moving or not moving either of his interceptor class spacecraft during his turn. Only one spacecraft may occupy any hexagon at one time and if a spacecraft's course intersects a hexagon occupied by another spacecraft and if the moving spacecraft has the velocity to carry it beyond the occupied hexagon, then it merely counts the occupied hexagon as one of those traversed in the completion of its move. However, if the moving spacecraft's velocity is such that the completion of its move would bring it to rest on an occupied hexagon, it must stop on the hexagon it reaches immediately before the occupied hexagon. The movement of the spacecraft inside of the star's gravitational field consists of circular orbits and parabolic trajectories. Complete trajectories carry a spacecraft past the star to the other side of the star's solar system. This is illustrated by the spacecraft initially in the hexagon labelled 57 travelling the parabolic path 58 to the hexagon labelled 59. Hexagons 57 and 59 are directly opposite each other and it is to be noted that the position of the spacecraft is parallel to the parabolic trajectory both at its initiation and completion of movement. When a spacecraft begins its movement, it may turn no more than one hexagon side from its original direction of travel as it traverses each hexagon. Thus, in order for a spacecraft to make a 180 degree turn, it must traverse three hexagons. As illustrated in FIG. 3, a spacecraft located in hexagon 54 must travel a path 55 and reach hexagon 56, for example, in order to change directions by 180 degrees. However, a spacecraft loses velocity every time it changes direction except under special circumstances explained below. It loses one hexagon of velocity for every turn it makes but the new decreased velocity is not used by the spacecraft until the player's next turn. At the completion of a spacecraft move in which velocity is lost, the decreased velocity is recorded on the velocity indicator by replacing the old white velocity card located under the spacecraft indentifier card with the new white velocity card in the case of the embodiment using the velocity indicator assembly or by replacing the velocity indicator piece on the effected space-craft in the embodiment using the velocity indicator piece in lieu of the velocity indicator assembly. A spacecraft moving on a parabolic trajectory toward the star may turn with the direction of the curve into a circular orbit around the star without losing velocity. In a similar fashion, a spacecraft moving on a parabolic trajectory away from the star may turn with the direction of the curve into a circular orbit around the star without losing velocity. Furthermore, a spacecraft traveling in a circular orbit around a star may move into either a lower or higher circular orbit, continuing in the same direction without losing velocity. Within the gravity field of the star, a spacecraft moving on a parabolic trajectory either toward or away from the star, turning against the direction of the curve into a circular orbit around the star loses one hexagon of velocity per player turn. With regard to the six pentagon spaces used as orbiting positions for Chronos, they are never landed on by the spacecraft but are always skipped over and when a spacecraft skips over a pentagon it does not count as one of the hexagons traversed. While a traversal of a pentagon may include a direction change, there is no loss of velocity. When a spacecraft comes into the gravity field of either of the planets, the gravity fields of these planets may be used to accelerate the spacecraft by an additional hexagon of velocity per player move. This is illustrated in FIG. 3 by the spacecraft located in hexagon 81 which follows the path 82 to hexagon 83. When the spacecraft lands in hexagon 81 when the planet is located in hexagon 80, the spacecraft may be immediately moved to hexagon 83 without counting the hexagons traversed as part of the total number of hexagons allowed. In addition, when the spacecraft has finished its move, the velocity indicator means is updated to indicate a new increased velocity. When a spacecraft occupies a hexagon which is contiguous with a hexagon occupied by a spacecraft of another player, that spacecraft may fire its laser in an attempt to score against and eliminate the other spacecraft. A spacecraft may fire upon aother spacecraft regardless of the direction that the antagonist spacecraft is facing and the attack may occur in the course of the antagonist spacecraft's move, while it is passing the other spacecraft. Whether or not the laser scores against the spacecraft of another player is simulated by the roll of dice with the dice being used to define a probability distribution of a "hit." When the dice are rolled, the sum of the numbers on the top faces are compared to a critical number and when that sum is less than or equal to the critical number, a "hit" is declared and the "hit" spacecraft is removed from the playing board. Table 1 defines the critical number for the interaction of the various classes of spacecraft. It is to be noted that the home station can be fired upon but has no lasers of its own. TABLE 1__________________________________________________________________________Probability That Spacecraft of Class in Columns Will EliminateSpacecraft of Class in Rowscolumns → ALPHA DELTA ZETArows (black) (silver) (gold) INTERCEPTOR↓ P ≦ C.N.* P ≦ C. N. P ≦ C. N. P ≦ C. N.__________________________________________________________________________ALPHA 28% 5 72% 8 97% 11 72% 8DELTA 17% 4 58% 7 97% 11 58% 7ZETA 3% 2 28% 5 97% 11 28% 5INTERCEPTOR 17% 4 58% 7 97% 11 58% 7HOMESPACE 17% 4 58% 7 97% 11 58% 7STATION__________________________________________________________________________ *C. N. = Critical Number = sum of numbers on die faces using cubic dice With regard to the interceptor class spacecraft, these spacecraft may move only outside the star's gravitational field and, in addition, may not fire upon spacecraft inside of the gravity field while conversely, spacecraft located inside the gravitational field may not fire upon the interceptor class spacecraft. A player has the option of not moving the interceptor class spacecraft or moving either one or both of the spacecraft during a player turn. When an interceptor class spacecraft is moved, it may traverse either one or two hexagons per turn and may make a sixty degree turn in either one or both of the hexagons it traverses without a velocity loss. A fundamental goal of each player is to orbit the star with each spacecraft in order to gain "points". In the case of a game played with three or four players, five circular orbits, illustrated as orbits 100-104 in FIG. 1, may be used to obtain points. The orbit is considered to have begun at the first hexagon traversed by the spacecraft in orbit 104. An orbit marker corresponding to that spacecraft is placed in the aforesaid traversed hexagon and the spacecraft must make a complete revolution around the star until the spacecraft reaches either the hexagon containing the orbit marker or reaches any of the five hexagons located along a parabolic trajectory beginning at the orbit marker as illustrated by line 105 in FIG. 1. The spacecraft may move toward or away from the star while orbiting as long as the spacecraft continues in the direction (clockwise or counterclockwise in which it was moving when it traversed the initial hexagon upon which its orbit marker was placed. When a spacecraft completes its point orbit, its orbit marker is removed from the board and either the velocity identifier card is reversed from its white side to its purple side or the white velocity indicator piece is replaced by a purple velocity indicator piece. When that spacecraft lands on one of the six hexagons contiguous to its home station hexagon, the velocity identifier card is again reversed to white or the velocity indicator piece changed to a white piece and a point piece is placed on the home station hexagon. The spacecraft is then repositioned on that hexagon in accordance with the initial alignment of the alpha class spacecraft initially placed on that hexagon at the beginning of the game, and with the initial velocity of 3. New spacecraft, which are provided in exchange for the point pieces, are placed on any unoccupied hexagon contiguous with the home station hexagon. This is done only at the completion of a player's turn and the new spacecraft is not moved until the player's following turn. A new alpha class spacecraft requires the exchange of one point piece, while a delta class or intercepter class spacecraft requires the exchange of two point pieces. In addition, a zeta class spacecraft requires the exchange of three point pieces. The only rule governing the order in which the spacecraft can be introduced into the game is that before a player can exchange point pieces for a zeta class spacecraft, he must have previously exchanged point pieces for at least one delta class spacecraft. The orbiting procedures for two players are essentially the same as that for three or four players with the exception being that orbits labelled 103 and 104 in FIG. 1 are eliminated for use as point orbits with the orbit label 102 being the initiating the point orbit. If an attacked spacecraft has an associated point piece and is hit, the attacking spacecraft claims the point piece in addition to eliminating the attacked spacecraft. While preferred forms and arrangements have been shown in illustrating the invention, it is to be clearly understood that various changes in detail and arrangement may be made without departing from the spirit and scope of this disclosure.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority under 35 U.S.C. §119(e) from U.S. Provisional Patent Application No. 60/358,733, filed Feb. 25, 2002 and incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates, in general, to fail-safe modules and, more particularly, to fail-safe modules integral with sedation and analgesia systems. BACKGROUND OF THE INVENTION [0003] In response to, among other things, market conditions and popularity amongst cost-conscious patients, out-of-hospital procedures continue to experience rapid growth. For various reasons, clinicians such as, for example, in office, ambulatory center, dental, non-hospital and hospital settings sometimes administer or supervise the delivery of sedation and analgesia without the services of trained anesthesia providers. This development has led the American Society of Anesthesiologists to issue guidelines for the delivery of sedation and analgesia by non-anesthesiologists. Because the non-hospital setting is in general not as well equipped and staffed as hospitals, malfunctions and complications (such as unintended over-medication leading to loss of consciousness and airway reflexes) may lead to severe outcomes. [0004] A sedation and analgesia system is described in commonly assigned and co-pending U.S. patent application Ser. No. 09/324,759, filed Jun. 3, 1999. This system safely provides patients undergoing painful, uncomfortable or otherwise frightening (anxiety inspiring) medical or surgical procedures with sedative, analgesic, and/or amnestic drugs in a way that reduces the risk of overmedication, in both non-hospital and hospital settings. As this system may be used in settings where users may not be trained anesthesia providers skilled in resuscitation and airway management and where complications or malfunctions may have more severe repercussions, the number of potential failure modes was systematically reduced by elimination and/or mitigation. Mitigation was partly accomplished by careful design of the fail safe module for the sedation and analgesia system. Thus, the sedation and analgesia system may be safer than anesthesia machines for use in both non-hospital and hospital environments and may be safely operated by individuals other than trained anesthesia providers such as, for example, trained physicians, or other licensed clinicians and operators. [0005] Anesthesia machines are mainly designed for inhalational anesthesia. In general, as a legacy from earlier anesthesia machine designs that were entirely pneumatic and did not require electrical power to operate, loss of electrical power in current anesthesia machines will not interrupt delivery of anesthetic gases and vapors. In contrast, one embodiment of the sedation and analgesia system described in the '759 application uses only intravenous anesthetics and no inhalational anesthetics and requires electrical power to operate. During sedation and/or analgesia, continued safety in the absence of an anesthesia provider is paramount. These safety systems often employ a set of complicated features to prevent anesthesia machines from being switched off during an anesthetic. [0006] Existing fail-safe systems used on anesthesia machines have the ability to fall back on an all-pneumatic operation mode of operation and may not be applicable to the needs of a sedation and analgesia or total intravenous anesthesia system requiring electrical power to operate. Furthermore, because the sedation and analgesia system is also designed for use by non-anesthesia providers, the consequences of equipment failure may be more severe and thus fail safe systems with a higher reliability that those used on anesthesia machines designed for use by anesthesia providers are required. [0007] Due to the importance of patient safety, test modes for drug delivery devices have long been accepted as an important feature. However, existing fail-safe systems may not take into account the specific requirements that the fail-safe system itself may need to be tested to attain a high-reliability sedation and analgesia system. Simulating a failure to test the fail-safe system for a sedation and analgesia system may be disruptive and cause the system to power down upon detection of the simulated failure. Upon termination of the simulated failure, if the system was powered down, the system will power up and cause further disruption, especially if the power-up, including power-up on self test (POST) routines, takes a long time to complete. Therefore, a need has arisen for a fail-safe module that may be tested without untoward system disruption, in order to confirm proper function of the fail-safe system in a high-reliability sedation and analgesia system. [0008] Further fail-safe systems implement methods of incorporating redundant constituent elements (modules) into the systems. A further need has arisen for a watchdog system integral with a sedation and analgesia system that powers down the sedation and analgesia system in the event of a detected malfunction. SUMMARY OF THE INVENTION [0009] The present invention provides a fail-safe module (FSM) integral with a sedation and analgesia system that meets the high-reliability needs of sedation and/or analgesia delivered by non-anesthetists. The FSM may operate in “real-time” in order to ensure optimal patient safety. The FSM may deactivate specific patient interfaces, user interfaces, and/or sedation and analgesia delivery in order to ensure patient safety and has redundant safety systems in order to provide the fail-safe module with an accurate assessment of controller functionality. [0010] The present invention further includes a FSM measuring the functionality of software and/or hardware associated with critical patient interfaces and/or the sedation and drug delivery system. The FSM may reactivate patient interfaces, user interfaces, and/or sedation and analgesia delivery upon receipt of acceptable data indicating an operable controller. The FSM also may retain in memory a failure event in order to alert the next user that the machine has experienced a failure. The FSM may be included with a test mode capability that simulates a failure. During the simulated failure to test the FSM, automatic system power-down may be bypassed to create minimum system disruption. The simulated failure may be programmed to occur only on power-up or during normal operation. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 is an overall conceptual schematic block diagram of a system in accordance with the present invention; [0012] FIG. 2 is an overall schematic block diagram of a fail-safe module system in accordance with the present invention; [0013] FIG. 3 is a more detailed schematic block diagram of a fail-safe module illustrating associated inputs and outputs in accordance with the present invention; [0014] FIG. 4 is a flow chart illustrating operation of a fail-safe module system in accordance with the present invention; and [0015] FIG. 5 is a flow chart illustrating a method of operating a fail-safe test mode in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION [0016] FIG. 1 illustrates a block diagram depicting one embodiment of the present invention comprising sedation and analgesia system 22 having fail-safe module 23 , user interface 12 , controller 14 , peripherals 15 (which may include a memory device), power supply 16 , external communications 10 , patient interfaces 17 , and drug delivery 19 , where sedation and analgesia system 22 is operated by user 13 in order to provide sedation and/or drugs to patient 18 . An example of sedation and analgesia system 22 is described in co-pending and commonly assigned U.S. patent application Ser. No. 09/324,759, filed Jun. 3, 1999 and incorporated herein by reference. Patient interfaces 17 may comprise one or more physiological monitors, such as SpO2, ECG, CO2 and NIBP among others. [0017] The sedation and analgesia system of application Ser. No. 09/324,759 includes a patient health monitor device (such as patient interfaces 17 ) adapted so as to be coupled to a patient and generate a signal reflecting at least one physiological condition of the patient, a drug delivery controller supplying one or more drugs to the patient, a memory device storing a safety data set reflecting safe and undesirable parameters of at least one monitored patient physiological condition, and an electronic controller interconnected between the patient health monitor, the drug delivery controller, and the memory device storing the safety data set; wherein said electronic controller receives said signals and in response manages the application of the drugs in accord with the safety data set. [0018] FIG. 2 illustrates a block diagram depicting fail-safe module system 60 having controller 14 , fail-safe module 23 , power supply 24 , controller input 25 , controller output 26 , drug delivery 19 , and patient interface 17 , where drug delivery 19 and patient interface 17 interact with patient 18 . Controller 14 receives input from patient interface 17 , drug delivery 19 , fail-safe module 23 , and other peripherals associated with sedation and analgesia system 22 . Data is inputted into controller 14 which executes a program designed in a language, such as, for example, C or C++, and functions within an operating system such as, for example, QNX. However other operating systems such as, for example, LINUX, VX Works, or Windows NT are contemplated. Preferred embodiments of the software operate in a “real time” operating system such as, for example, QNX, where programs relating to specific patient interfaces, user interfaces, and other features of sedation and analgesia system 22 are compartmentalized into separate program modules (not shown). [0019] Controller 14 may be a CPU, or any other data processing system commonly known in the art. Controller 14 may further comprise, in one embodiment of the present invention, a health-check system (not shown) based, for example, on functionalities provided by the QNX operating system, where the health-check system sends a health check-request (not shown) to a program module (not shown) associated with a feature such as, for example, a system for the automated assessment of consciousness or responsiveness. Such an automated assessment system is described in the '759 application and in U.S. patent application Ser. No. 09/324,759 filed Dec. 28, 2002. Upon receipt of a health-check request, the program module is programmed to respond with a health check response. A malfunction of a program module will result in the failure of the module to deliver a health-check response to the health check system integral with controller 14 . The health-check request and health-check response may be in the form of a singe byte, a plurality of bytes, a pulse, a TTL or logic signal, or other forms of data transfer suitable for use with the present invention. If the health check system fails to receive a health check response from a program module within a given time window, controller 14 will alert fail-safe module 23 that a failure has occurred resulting in fail-safe module 23 transferring sedation and analgesia system 22 into safe state mode 107 ( FIG. 4 ) as will be further discussed herein. The health check system is software based and exploits the inherent features of operating systems such as QNX, specifically the allocation of individual reserved memory space for each compartmentalized software program module. [0020] In one embodiment of the present invention, data and/or commands may be outputted from controller 14 in the form of output 26 to peripherals associated with sedation and analgesia system 22 , fail-safe module 23 , and patient interface 17 . Depending on the functionality of controller 14 and program modules associated with controller 14 , controller 14 may be functioning properly, or may be outputting aberrant commands. In the event that controller 14 has malfunctioned and is outputting spurious commands and/or data, such as, for example, excessive drug delivery, fail-safe module 23 may detect improper operation in controller 14 associated with the failure and transfer sedation and analgesia system 22 into safe state mode 107 ( FIG. 4 ). [0021] In one embodiment of the present invention, controller 14 is programmed to deliver, or initiate delivery of, a strobe (not shown) to fail-safe module 23 within a predetermined window such as, for example, from between 900 to 1100 milliseconds. The strobe may be in the form of a byte, a plurality of bytes, a pulse, a TTL or logic signal or other forms of data transfer suitable for use with the present invention. Fail-safe module 23 , in one embodiment of the present invention, must receive the strobe initiated by controller 14 within the predetermined time window in order to maintain sedation and analgesia system 22 in an operation state mode 105 ( FIG. 4 ). The failure of controller 14 to initiate and deliver the strobe within the specified window indicates to fail-safe module 23 that an anomaly has occurred in the health check system or in the program modules associated with sedation and analgesia system 22 , resulting in fail-safe module 23 transferring sedation and analgesia system 22 into safe state mode 107 . A further embodiment of the present invention comprises providing a direct communication (not shown) between the program modules associated with sedation and analgesia system 22 and fail-safe module 23 in order to provide redundancy in verifying the program modules are functioning properly. An even further embodiment of the present invention comprises providing direct communication between patient interface 17 and/or drug delivery 19 to provide redundancy in verifying that program modules associated with critical peripherals are functioning properly. FIG. 2 further illustrates one embodiment of the present invention, where power supply 24 is connected to and powers fail-safe module 23 . In one embodiment of the present invention, power supply 24 delivers 0.5-200 volts DC and preferably 4.75-5.25 volts DC, and is capable of sourcing 0.5-200 amps and preferably 12 amps, and may be referenced to a system ground. The present invention further contemplates the use of alternating current. [0022] FIG. 3 illustrates a block diagram depicting one embodiment of the present invention comprising fail-safe module 23 , inputs 30 , 32 , 34 associated with fail-safe module 23 , outputs 31 , 33 , 35 associated with fail-safe module 23 , and power supply 24 . Fail-safe module 23 comprises memory 27 , state machine 28 , and communications (comm) switching 29 . Fail-safe module 23 may be a central processing unit, a complex programmable logic device (CPLD), or any other suitable data processing device. In one embodiment of the present invention, state machine 28 receives state machine input 32 , where state machine input 32 comprises a fail-safe strobe, information relevant to controlling oxygen and drug delivery, information relevant to oxygen and drug enablement, information relevant to oxygen and drug disablement, and/or other suitable state machine input. Memory 27 receives memory input 30 , where memory input 30 includes, but is not limited to, information relevant to clearing fail-safe module 23 of a system fault event. Comm switching 29 receives input from comm switching input 34 , where comm switching input 34 includes, but is not limited to, commands to the drug delivery module, such as among others an IV pump, from the controller 14 , and commands to the non-invasive blood pressure module from controller 14 . In one embodiment of the present invention, comm switching 29 functions to convert RS-232 signals to transistor logic (TTL). [0023] Memory 27 outputs memory output 31 , where memory output 31 includes, but is not limited to, information related to a failure event occurring after the last clearing of the memory 27 via memory input 30 . State machine 28 outputs state machine output 33 , where state machine output 33 includes, but is not limited to, an indication of an unknown system fault, output related to fail-safe module 23 control of the flowrate of oxygen and drug, and output relating to fail-safe module 23 control of enabling or disabling oxygen and drug delivery. Comm switching 29 outputs comm switching output 35 , where comm switching output 35 includes, but is not limited to, information from controller 14 dictating function of the pump (not shown) associated with drug delivery 19 , where the fail-safe module disables, for example, grounds, the signal if a problem is detected, and information from controller 14 dictating function of the blood pressure cuff, where the fail-safe module disables the signal if a problem is detected so that the blood pressure cuff is not left in an inflated position where it may cut off blood circulation. Routing control of oxygen delivery, the non-invasive blood pressure module (not shown), and drug delivery 19 through fail-safe module 23 , allows fail-safe module 23 to disable the non-invasive blood pressure module and drug delivery 19 in order to prevent potential harm to a patient due to error. Oxygen delivery may be maintained, at a predetermined flow-rate and for a predetermined period of time, by fail-safe module 23 , if oxygen was being administered at the time of the failure. A plurality of other inputs and outputs, such as those described in U.S. patent application Ser. No. 09/324,759, are consistent with the present invention, as well as a plurality of patient interfaces such as, for example, capnometry monitoring, that may be routed through the fail-safe module 23 in order to provide desired safe state mode 107 . [0024] In one embodiment of the present invention, memory 27 functions to maintain a record of failure events occurring within controller 14 or in the program modules associated with controller 14 . Information related to a failure is transmitted to memory 27 via error output path 36 . Memory of the failure will be maintained within memory 27 until a command is entered acknowledging the failure and clearing the memory via memory input 30 . Memory 27 functions to alert a user, via memory output 31 , that sedation and analgesia system 22 has, in the previous case, experienced a failure. The recorded failure in memory 27 may be removed via memory input 30 . In one embodiment of the present invention, the user may not activate the sedation and analgesia system until the failure recorded in memory 27 is acknowledged and removed. Memory of a software failure may be held in memory 27 by encoding a simple memory bit, or by other suitable means of recording a failure. One embodiment of the present invention comprises a code retained in memory 27 indicating whether the failure occurred in the program modules associated with controller 14 or in the health-check system, if the health-check system is present. [0025] State machine 28 is, in one embodiment of the present invention, programmed to anticipate a strobe from controller 14 within a specified time window. The time window may be any window desirable for use in detecting flaws within the sedation and analgesia system 22 . If the strobe is received by state machine 28 of fail-safe module 23 within the specified time window, fail-safe module 23 will maintain sedation and analgesia system 22 in operation state mode 105 . If the strobe is not received by state machine 28 within the specified time window, state machine 28 will output information related to the failure via state machine output 33 in the form of a visual alarm, an audio alarm, and/or other suitable means for alerting a user that a failure has occurred. In response to a failed strobe, state machine 28 will also send data indicating a failure to memory 37 via error output path 36 and transfer sedation and analgesia system 22 into safe state mode 107 . In one embodiment of the present invention, state machine 28 disables control of comm switching 29 by controller 14 , via disable output 37 , in order to transfer sedation and analgesia system 22 into safe state mode 107 independent of controller 14 . [0026] A further embodiment of the present invention comprises controller 14 programmed to rapidly strobe state machine 28 in the event of a failure in the modules associated with controller 14 . State machine 28 is programmed, upon receipt of rapid strobing from controller 14 , to output an alarm signal indicator of a sedation and analgesia system 22 failure, record the failure in memory 27 , disable control of comm switching 29 by controller 14 , and transfer sedation and analgesia system 22 into safe state mode 107 . [0027] FIG. 4 depicts a method illustrating one embodiment of the operation of fail-safe module 23 in this sedation and analgesia system 22 . Commencing from a fail-safe module system (FSM) inactive mode 100 , the sedation and analgesia system 22 only moves into initiation state mode 102 upon receipt of power (query 101 ) applied to fail-safe module 23 . For example, initiation state mode 102 will commence upon receipt of 5 volts of direct current from power supply 24 , however other voltages and means of delivering power to fail-safe module 23 are consistent with the present invention. Any time power is removed from fail-safe module 23 , sedation and analgesia system 22 will return to fail-safe module system inactive mode 100 . Following reception of power, sedation and analgesia system 22 will operate in an initiation state mode 102 comprising fail-safe module 23 outputting safe state output in anticipation of a strobe from controller 14 . In one embodiment, fail-safe module 23 outputs safe state data until a valid strobe is received from controller 14 due to the fact that the condition of sedation and analgesia system 22 cannot be determined until valid strobing begins. Maintaining safe state output during the initiation state mode 102 ensures the controller 14 cannot send commands to important peripherals, such as, for example, drug delivery 19 or patient interface 17 , until fail-safe module 23 receives a valid strobe indicating controller 14 is healthy. Initiation state mode 102 further comprises disallowing user 13 from removing the record of a failure event stored in memory 27 until a valid strobe is received from controller 14 indicating sedation and analgesia system 22 is functioning properly. In the absence of a valid strobe, sedation and analgesia system 22 will remain in initiation state mode 102 . One embodiment of the present invention comprises powering down sedation and analgesia system 22 in the event that a valid strobe is not received during a predetermined window of, for example, five minutes. [0028] Upon reception of a valid strobe from controller 14 by fail-safe module 23 (query 104 ), sedation and analgesia system 22 will be transferred to operation state mode 105 . Operation state mode 105 is maintained contingent on valid strobing (query 106 ) from controller 14 to fail-safe module 23 that falls within the allowed predetermined window. Consistent valid strobing from controller 14 to fail-safe module 23 maintains sedation and analgesia system 22 in an operation state mode 105 . Operation state mode 105 comprises allowing input received by fail-safe module 23 from controller 14 to control output relating to critical patient interfaces such as, for example, blood pressure cuff pressure, oxygen delivery, and drug delivery 19 . Operation state mode 105 further comprises indication to user 13 that sedation and analgesia system 22 is functioning properly. Data will continue to be displayed on the user interface 12 , backlighting of user interface 12 will remain active, and alarm signals relating to sedation and analgesia system 22 failure will remain quiet. One embodiment of the present invention comprises allowing user 13 or fail-safe module 23 to clear the memory unit held in memory 27 that previously indicated a failure in sedation and analgesia system 22 in order for a subsequent failure to recode the memory unit (not shown). [0029] Failure to strobe, or rapid strobing of fail-safe module 23 (query 106 ) by controller 14 results in fail-safe module 23 transferring sedation and analgesia system 22 into safe state mode 107 . Strobes falling outside the predetermined response window, or rapid strobing from controller 14 indicate to fail-safe module 23 that a failure has occurred in sedation and analgesia system 22 . In order to protect the patient, it is necessary to convert sedation and analgesia system 22 into a safe state mode 107 to reduce potential harm caused by drug delivery 19 , patient interface 17 , or other critical peripherals that may include malfunctioning hardware or software. Safe state mode 107 comprises, in one embodiment of the present invention, ceasing transmission of command data from controller 14 to drug delivery 19 , patient interface 17 , oxygen delivery, and/or other critical peripherals related to patient safety. Safe state mode 107 further comprises deactivating drug delivery 19 in order to prevent possible patient overdose, deactivating the blood pressure cuff in order to prevent possible necrosis that occurs if the blood pressure cuff is left inflated for extended periods of time, and maintaining the flow of oxygen, if oxygen was being given during the procedure, in order to maintain suitable oxygen saturation of the blood. Safe state mode 107 further comprises triggering the memory bit located in memory 27 to indicate a sedation and analgesia system 22 failure 109 , sounding an audio alarm, signaling a visual alarm, and/or blanking the display such as, for example, by deactivating the backlight on user interface 12 . The backlight on user interface 12 may be deactivated in order to prevent display of spurious data that may be erroneously used to evaluate a patient's condition. [0030] Following the transfer of sedation and analgesia system 22 to safe state mode 107 , fail-safe module 23 will continue to anticipate valid strobing from the main logic board or controller 14 (query 108 ). Absent valid strobing, fail-safe module 23 will maintain safe state mode 107 . In one embodiment of the present invention, alarms associated with fail-safe module 23 may be manually deactivated by user 13 . Upon reception of a valid strobe, or a predetermined number of valid strobes from controller 14 , fail-safe module 23 may transfer sedation and analgesia system 22 from safe state mode 107 to operation state mode 105 . A further embodiment of the present invention comprises sedation and analgesia system 22 remaining in safe-state mode for the duration of the medical procedure, even in the event of a valid strobe from controller 14 . [0031] Query 110 relates to user 13 response to safe state mode 107 . If sedation and analgesia system 22 is turned off, sedation and analgesia system 22 will be transferred to fail-safe module inactive mode 100 . If sedation and analgesia system 22 is not deactivated, fail-safe module 23 will maintain sedation and analgesia system 22 in safe state mode 107 . [0032] FIG. 5 depicts a method illustrating one embodiment of a test mode 210 for sedation and analgesia system 22 comprising the steps of: initiating a valid test strobe 200 , transferring sedation and analgesia system to the operation state mode 201 , setting inputs to the FSM 202 , outputting a test signal from the controller 203 , evaluating proper outputs of FSM in operation state mode given current inputs 204 , initiating valid test strobe 205 , transferring the sedation and analgesia system to the safe state mode 206 , evaluating proper outputs of FSM in safe state mode given current inputs 207 , initiating valid strobing from the controller 208 , and transferring the fail-safe module to the operation state mode 209 . [0033] In one embodiment of the present invention, initiating a valid test strobe step 200 comprises transmitting one or a plurality of strobes from controller 14 to fail-safe module 23 that fall into the predetermined time window programmed into fail-safe module 23 , indicating that controller 14 is functioning properly. In one embodiment of the present invention, initiating a valid test strobe step 200 occurs during initiation state mode 102 after power has been delivered to controller 14 and fail-safe module 23 . [0034] Transferring sedation and analgesia system to the operation state mode step 201 comprises, fail-safe module 23 receiving the valid strobe or strobes from controller 14 , where the valid strobe or strobes indicate to fail-safe module 23 that controller 14 is functioning properly, then converting sedation and analgesia system 22 to operation state mode 105 based on the valid strobe or strobes indicating that sedation and analgesia system 22 is functioning properly. [0035] Setting initial inputs to FSM step 202 comprises inputting information related to oxygen delivery, drug delivery 19 , patient interface 17 , or other critical parameters relating to a desired safe state mode 107 . In one embodiment of the present invention, setting initial inputs to FSM step 202 occurs during operation state mode 105 , where controller 14 maintains control of critical parameters. [0036] Outputting a test signal from the controller (step 203 ) comprises, user 13 inputting a test command into controller 14 , where the inputted test command decouples the power down functionality from detected failure of sedation and analgesia system 22 . One embodiment of the present invention comprises an automated system of initiating a test command, where the test command is initiated by controller 14 at a predetermined time before the beginning of a medical procedure, for example as part of the power-up routine of a sedation and analgesia system. In one embodiment of the present invention, a test bit (not shown) is triggered in fail-safe module 23 upon receipt of the test command from controller 14 . The triggered test bit of fail-safe module 23 may function to disable the power down capability associated with a failure, in order to test the functionality of fail-safe module 23 without initiating a power down. Providing a FSM test mode, absent a power down, obviates the need to retest fail-safe module 23 following a subsequent power up of the system had the system been powered down as part of the simulated failure. [0037] Evaluating proper outputs of the FSM in the operation state mode given current inputs (step 204 ) comprises determining whether fail-safe module 23 is outputting data consistent with inputted data. In evaluating proper outputs of the FSM in the operation state mode given current inputs (step 204 ), outputted data should be consistent with inputted data due to the retention of control of critical parameters associated with fail-safe module 23 by controller 14 . [0038] Initiating invalid test strobe (step 205 ) comprises outputting an invalid strobe from controller 14 to fail-safe module 23 , simulating a failure of sedation and analgesia system 22 . The invalid test strobe may be rapid strobing of fail-safe module 23 by controller 14 , strobing outside the predetermined time window, or other suitable means of communicating a failure of sedation and analgesia system 22 . [0039] Transferring the sedation and analgesia system to the safe state mode step 206 comprises transferring sedation and analgesia system 22 to safe state mode 107 following receipt by fail-safe module 23 of an invalid strobe. In order to prevent the need for repetitive retesting upon power up of sedation and analgesia system 22 were it to be powered down during the simulated failure, sedation and analgesia system 22 is not powered down during test mode 210 . [0040] Evaluating proper outputs of the FSM in the safe state mode given current inputs (step 207 ) comprises determining whether fail-safe module 23 is functioning properly in converting sedation and analgesia system 22 to safe state mode 107 . Evaluating proper outputs of the FSM in the safe state mode given current inputs (step 207 ) allows controller 14 to determine if fail-safe module 23 will function properly, in the event of an actual failure, in converting sedation and analgesia system 22 to safe state mode 107 . [0041] Initiating valid strobing from the controller step 208 comprises outputting a valid strobe or strobes from controller 14 to fail-safe module 23 following the transfer of sedation and analgesia system to safe state mode 107 . Upon receipt of valid strobing, that is, strobing falls within the predetermined response window, fail-safe module 23 will transfer sedation and analgesia system 22 to operation state mode 105 , reallocating control of drug delivery system 19 , patient interface 17 , and oxygen delivery to controller 14 . Transfer of sedation and analgesia system 22 from safe state mode 107 to operation state mode 105 following successful strobing is consistent with transferring the sedation and analgesia system to the operation state mode (step 209 ). [0042] Test mode 210 provides user 13 with a simulation of a failure event or message, where the response of fail-safe module 23 may be tested, in the absence of a power down, to determine whether it functions properly in transferring sedation and analgesia system 22 to safe state mode 107 and operation state mode 105 at the appropriate times. The memory bit recorded in memory 27 of the fail-safe module 23 may be reset upon transfer of sedation and analgesia system 22 to operation state mode 105 . [0043] In one embodiment of the invention, the health check system polls each compartmentalized software module and verifies that each one indicates that it is operating properly. Upon receipt from all compartmentalized software modules that all is well, the health check system strobes the FSM to indicate that all system modules are functioning properly. This health check system occurs at all times that the system is running. The health check system is software based and the FSM is implemented via hardware such as a complex programmable logic device (CPLD).

1a

BACKGROUND OF THE INVENTION Heart failure remains a leading cause of disability and mortality in the United States and other Western nations. Heart failure progressing to end-stage cardiomyopathy can develop among patients with ischemic heart disease secondary to significant coronary atherosclerosis. Patients with viral myocarditis or valvular disease also are at risk for developing significant cardiomyopathy. Cardiac transplantation, ultimately, is the therapy for end-stage cardiomyopathy, whether the etiology is ischemic or non-ischemic, if pharmacologic measures fail. Transplantation however is limited by the available supply of donor organs. Consequently, efforts have been directed towards developing safe, implantable and long-term means of mechanical support for the patient awaiting transplantation. FDA approval has been granted to several mechanical ventricular assist devices (VADs) with application as a “bridge-to-transplant.” Clinical studies demonstrate that implantation of such a device provides sufficient circulatory support to aid the patient's recovery from sequelae of end-stage cardiomyopathy such as renal and hepatic failure, and to allow physiologic rehabilitation until a donor heart is available. Cardiac arrhythmia is a significant complication of end-stage cardiomyopathy, with patients prone to developing either atrial fibrillation, resulting in an irregular rhythm with increased potential for stroke, or potentially fatal ventricular tachyarrythmias such as ventricular tachycardia or fibrillation. Cardiomyopathy patients can also develop bradyarrhythmia, or an abnormally slow heart rate. Treatment of these conduction disorders can require implantation of a permanent pacemaker, an automatic internal cardiac defibrillator or both. As the clinical experience with implantable VADs has increased several investigators have observed a number of chronic heart failure patients who demonstrate not only recovery of end-organ damage and functional improvement, but also recovery of myocardial function following VAD implantation. These patients demonstrated recovery by several clinical parameters of myocardial function, including improved myocardial contractility or wall motion seen on serial echocardiography, increased exercise capacity greater than that expected from mechanical support alone, and the ability to maintain adequate cardiac output during periods of temporarily decreased VAD support. Only a few such patients have undergone VAD explantation and maintained native heart function sufficient to sustain life. However, it appears that long-term implantable mechanical ventricular assist devices can be applied in select patients not as a “bridge-to-transplant,” but as a “bridge-to-recovery.” The present invention aims at providing a physician with means for natural heart restoration. In other words, to enlarge the class of patients for whom VAD explantation is to be made possible. Furthermore among this enlarged class, it is expected that after explantation, some patients will do far better than barely sustaining life, but will gradually be able to engage in normal activities with a completely restored native heart. In the present application, the terms “natural heart” and “native heart” mean one and the same heart of the patient. BRIEF SUMMARY OF THE INVENTION The invention herein is an enhanced VAD device (EVAD), for a physician to use to restore a dysfunctioning native heart with severe muscular damages to good health, so that the EVAD can be removed (explanted) eventually. The EVAD device comprises a VAD, a controlled means for sending electrical pulses to the native heart, a graphical means for monitoring the patient's response to each of said electrical pulses from the controlled means, a set of attachments for measuring biological and or clinical signals at various organs both inside and outside the patient's body, and electronic means for the convenience of the physician. In our preferred embodiment, a “Linear Flow Blood Pump” (LFBP) is to be used as the said VAD device. [1] (Please see our list of references at the end of this application.) There are two reasons why we prefer to use LFBP: 1. LFBP has least likelihood of complications, such as thrombus. 2. LFBP gives a few valuable means at the physician disposal in caring for his patient, such as independently and timely controlled pressure pulses and blood flow volume. One or two LFBP can be used, depending on the patient's condition. The controlled means for sending electrical pulses to the native heart is a radio signal controlled artificial pace-maker (AP) with its pulse rate and intensity controllable by the radio signal. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 . shows the connections of an artificial pacemaker, and two VAD devices inside the patient's thorax. FIG. 2 . illustrates an instruction set converter. (ISC) FIG. 3 . illustrates the synchro-cardiac-graph (SCG) arrangement. FIG. 4 . illustrates multiple tapping of blood vessels for the input end of a RVAD. FIG. 5 . illustrates the placement of a LVAD beneath the diaphragm and the LVAD's main blood conduits. FIG. 6 . illustrates the operational links and feedback paths in the curing of a patient. DETAILED DESCRIPTION OF THE INVENTION As shown in FIG. 1 , the right ventricular assist device [RVAD] 1 taps into a systemic vein for its input 2 and its output 3 taps into a pulmonary artery. The left ventricular assist device [LVAD] 4 taps into a pulmonary vein for its input 5 and its output 6 taps into a systemic artery. Both ventricular assist devices operate in parallel with their respective ventricles, and both tap into blood vessels for their inputs and outputs. The heart itself is never tapped. Because our aim is to restore the natural heart to good health. It is preferable not to do any damage to the natural heart. The output electrical pulses 8 from the artificial pacemaker 7 is applied to the AV Node of the heart. Since the electrical wiring which is specially designed for transmitting such pulses, is very soft and flexible, it moves with the heart freely. The pulse rate and intensity of 8 are controlled by signal 9 which is issued either by the physician or by an AUTOPRO. The electronic means for the convenience of the physician is realized in FIG. 2 . As shown in FIG. 2 , the instruction set converter aims at isolating the physician from doing mechanical routine work. In our preferred embodiment, LFBPs are used for each VAD. One reason is that the LFBP output blood pressure and flow volume can be independently controlled by using the following LFBP Algorithm: “A pressure pulse in the direction of flow is generated by a sudden increase in the magnitude of the motor currents followed by a relatively gradual increase in the frequency of the motor currents. A pressure pulse against the direction of flow is generated by a sudden decrease in the magnitude of the motor currents followed by a relatively gradual decrease in the frequency of the motor currents. The ‘relatively gradual’ increase and decrease in frequency are in controlled amounts which are still quite fast. A gradual change in flow without pressure pulse is generated by a very slow and gradual change in the frequency of the motor currents. Thus the timing, magnitude, and direction of pressure pulses and change in flow volume without pressure pulses can be independently ordered by the physician.” While the LFBP Algorithm can be easily followed electronically by a computer or a digital signal processor (DSP), it would be much too much a distraction for the physician to give his clinical instructions in terms of motor current magnitude and frequency. In our preferred embodiment, inputs from the physician can be simple commands, for example: (i) LFBP output pressure pulses, magnitude, duration. (ii) gradual change in blood flow volume. (iii) combination of (i) and (ii). (iv) time sequences of the above inputs. (v) if A, then B We refer to the above commands (i) through (v) as prototype commands. Each of these has one or more assignable parameters. For instance: (i) may have parameters on the exact times for each pulse to occur, and the magnitude and duration of each. (ii) may have a parameter on the amount of change, or the final value of the desired flow volume, etc. (v) represents a conditional occurrence in which A defines a condition for the event B to occur. There can be associated parameters on both A and B. For instance, if A exceeds a given threshold, B is to occur with an assigned magnitude. For each prototype command, there can be default values for the parameters. The default values are selected by the physician. In our preferred arrangement, FIG. 2 illustrates a Digital Signal Processor based device for conversion of the prototype commands to the LFBP electrical motor currents which are specifically constituted for carrying out these commands. A Digital Signal Processor, or DSP for short, is a specialized micro-computer whose architecture is optimized for executing arithmetic instructions.[2] The DSPs, which currently run at 300 mega Hz, can execute multiplication in one clock cycle. Furthermore, the DSP's are software programmable. To follow the LFBP Algorithm in well designed steps is no problem. Referring to FIG. 2 , DSP 11 has two major components: a Programming and Arithmetic Logic (PAL) Unit 12 and a memory unit 13 . Both the physician's prototype command set 14 and the LFBP algorithm 15 are placed in the memory unit. With the physician's input, the selected prototype command 16 is placed in a memory slot 17 which is especially provided for the prototype command being executed. The PAL Unit 12 then converts the entry in memory slot 17 into LFBP currents 18 with specified amplitudes and frequencies as functions of time. The AUTOPRO 20 is to take care of the patient in the physician's absence. An AUTOPRO program starts with the physician's command If A, then B where A is a threshold condition on the clinical signal set 19 and B can be a prototype command 21 on the VAD(s) and/or a command 9 on the AP pace rate and/or intensity. The physician composes the AUTOPRO program by selecting A and B or a time sequence of A and B. With DSP's high speed, the conversion can be completed within a few millionth of a second, which is the equivalence of instantaneous in human time scale. FIG. 3 illustrates an SCG arrangement. The output 8 from AP 7 is also connected to the horizontal sweep voltage synchronizing input terminal 32 of monitor 30 . Selected clinical signal voltages 33 , 34 , and 35 are connected to the vertical input terminals 36 , 37 , and 38 of monitor 30 . Each clinical signal voltage is the sum of two components: (i) the component resulting from heart's response to each AP pulse, and (ii) the component resulting from other physiological factors. Since only the component (i) repeats after each AP pulse, component (i) is brightened by repetition. In contrast, component (ii) becomes a weak random blur. Thus SCG illustrates to the physician only the heart's responses to AP 8 pulses. In general, there can be many pertinent clinical signals 39 , and viewing all these signals simultaneously can be confusing. The switching DSP 40 offers the physician a way of viewing only a few selected signals such as 33 , 34 , and 35 at a time. The DSP 40 can also be used for other meaningful computations: For instance, the heart's output blood volume after each AP pulse, and the heart's output blood volume per minute, etc. FIG. 4 illustrates a distributed blood vessel tapping system. Because of the large volume of blood being pumped by the VADs, a single tapping may cause too much disturbance in the blood vessel at the point being tapped. FIG. 4 illustrates an alternative arrangement for the input line 2 of RVAD 1 in FIG. 1 . Instead of tapping at one point on the vein, a plural number of taps 41 , 42 , and 43 are made with cannulae 44 , 45 , and 46 respectively which converge to a single large cannula, 47 , before entering to the RVAD. Cannulae are specially designed blood conduits, which can be bent and also have the capability of standing up to external pressure or internal suction. If necessary, similar distributed arrangements can also be made for other VAD input output conduits 3 , 5 , and 6 of FIG. 1 . FIG. 5 illustrates the placement of a LVAD 52 below the diaphragm 51 . The output end 53 of 52 is branched into two blood conduits: a lower main outlet 54 , which supplies the arteries below the diaphragm 51 , and an upper main outlet which is connected to a cannula 55 The cannula 55 penetrates the diaphragm 51 to supply arteries above 51 . The blood inlet of LVAD 52 is supplied by a cannula 56 and a lower main inlet 57 . The cannula 56 collects blood from veins above the diaphragm 51 , and the main inlet 57 collects blood from veins below 51 . All the blood collected by 56 and 57 goes into the inlet end of LVAD 52 . FIG. 6 is an operational diagram illustrating two modes of operation: (i) in the presence of a physician, (ii) not in the presence of a physician. In Mode(i) operation, the physician derives his inputs from three sources: the Synchro-Cardiac Graph of FIG. 3 , slow varying clinical signals or data, and the physician's direct examination of the patient. From all these information, the physician decides on a therapeutic course of action which can include a prototype command, an AP instruction, and possible also some other means. The prototype command is then placed in memory slot 17 to be carried out through time varying LFBP motor currents 18 . However, in most of the time the patient is not with the physician, and the AUTOPRO is a sequential set of prototype instructions selected in advance by the physician. It starts with the If A, then B instruction, where A is a condition on the clinical signal 19 , and B is the physician selected course of action, including prototype command 21 , which is then placed in slot 17 for execution. FIG. 6 also illustrates the signal feed backs in a curing process, the physician derives his information about the patient from three sources: direct examination of the patient, the SCG, and other slow-varying clinical signals. Based on the total information, the physician selects a prototype command. This selection is made easier by the ISC which sets up the prototype commands. The ISC also helps in the conversion of the selected command into VAD motor electrical currents for its execution. In the mean time, the physician also sends controlling radio signal to the AP. Both the changes in AP output and in VAD output will have an effect on the patient. In its turn, the patient's response will have an effect on the outcome of the physician's observation or examination of the patient, on the SCG, and also on the clinical signals. In the absence of the physician, the AUTOPRO puts out a selected command, which has the same effect as a physician selected command in its execution, and also an AP controlling radio signal. In its turn, the patient's response will have an effect on the clinical signals, which in turn affects the AUTOPRO outputs. In our preferred arrangement, linear flow blood pumps (LFBPs) are used for both the VADs. By varying the LVAD electrical motor current magnitude and frequency as a function of time, the pressure pulses and blood flow volume at the LVAD output can be independently controlled. Only the flow volume is controlled for the RVAD. Since its only function is to provide adequate blood flow through the pulmonary circuit such that the red blood cells flowing into the LVAD and left vertricle carry sufficient oxygen Having described my invention in full, I respectfully submit that: 1. Other types of VAD can also be used with the present invention with their corresponding set of prototype commands. Thus, using other types of VAD does not constitute a new different invention. 2. General purpose microprocessors or computers can be used instead of the DSPs. It is a designer's choice, and does not constitute a new and different invention. 3. In our preferred embodiment, magnetic induction means are used for transference of signal, information, and power across the skin without puncturing the skin. These devices and methods are well known to persons skilled in the art, and will not be described here.

1a

FIELD OF THE INVENTION [0001] The present invention relates generally to an oral hygiene product. More particularly, the present invention relates to a dental composition such as a tooth paste, cream, gel or dentifrice, a mouth wash or rinse, a dental pack, or dental floss. Specifically, the invention relates to multi-functional dental products containing acetic acid. BACKGROUND OF THE INVENTION [0002] Bacterial aggregation on the teeth is known as plaque and causes dental caries, gingivitis, periodontitis and other gum diseases. A variety of microorganisms are present in the oral cavity. These range from the natural flora of the host to pathogenic species. Among these microorganisms are the gram-positive rods associated with the formation of plaque (a dense, enamel-adherent, microorganism-containing polysaccharide matrix). Specific areas, including periodontal and subgingival spaces, and interpapillary spaces of the tongue present environments that harbor bacteria. These spaces are difficult to reach by tooth brushing, and are only moderately affected by standard mouthwashes. Mechanical methods have been used for some time for the prevention of dental plaque but have not generally achieved sufficient results. Studies have shown that mechanical methods such as the use of dental floss and inter-space brushes do not efficiently eliminate plaque. The persistence of these microorganisms in such environments greatly increases the risk of calculus and plaque build up and carie formation, which in turn presents the danger of gingival inflammation and periodontal disease. Thus chemical plaque control as a substitute or supplement to mechanical methods is sought. [0003] U.S. Pat. No. 4,636,382 describes morpholino compounds which are useful for the inhibition or removal of dental plaque. The '382 patent also discloses that a wide variety of chemical and biological agents have been suggested for the inhibition of plaque, such as penicillin, chlorohexidine, 8-hydroxyquinoline and ethylenediamine tetraacetate. However, many of these chemical and biological agents are described as exhibiting insignificant effects and often causing serious side effects. U.S. Pat. No. 4,610,871 describes the use of monoalkyl or dialkyl ethers of dianhydrohexitols to inhibit the formation of plaque and calculus on teeth. U.S. Pat. No. 4,178,363 describes the use of n-undecylenic fatty acid or a calcium or zinc salt thereof for reducing dental plaque and infections of the teeth and gums. U.S. Pat. No. 4,119,711 describes spiro 1-(hydroxyalkyl)-piperidino derivatives which have efficacy in reducing the formation of plaque. U.S. Pat. No. 3,976,765 describes bis-biguanido hexanes in combination with nonionic surfactants and certain foam stabilizers for use in a variety of oral preparations. Additionally, U.S. Pat. No. 3,887,712 discloses that alexidine dihydrofluoride is useful in the treatment of dental plaque, calculus, gingivitis and related periodontal diseases. U.S. Pat. No. 4,160,821 discloses that a glycerine solution of zinc chloride or other acceptable zinc salts provides effective therapy for gingivitis when applied to the gingivae and teeth. U.S. Pat. Nos. 6,149,895; 5,240,415; 5,648,064; and 5,645,428 disclose teeth-bleaching compositions having as active ingredient hydrogen peroxide. U.S. Pat. No. 4,012,839 teaches a technique of disinfecting caries-infected or potentially caries-infected dental tissue with silver nitrate, silver thiocyanate or its complexes. U.S. Pat. No. 4,060,600 teaches a method of treating teeth in dentistry, for the prevention of calculus, removal of caries, and dissolution of plaque, comprising applying an aqueous solution containing a hypochlorite of an alkali and/or alkaline earth metal, and an amino compound capable of forming water-soluble non-mucous irritating N-chloro and/or N-dichloro derivatives thereof to the teeth. U.S. Pat. No. 4,327,079 provides a dentifrice composition containing synthetic hydroxyapatite powder which is neutral or weakly alkaline or contains 0.1 to 20% by weight of NaCl and/or KCl and 0.003 to 3% by weight of MgCl 2 as useful for fortifying a surface of a tooth, promoting remineralization of the surface of the tooth and eliminating plaque from the tooth. [0004] While it is thus clear that a variety of approaches have been tried in the past, efforts continue toward finding improved means for brightening teeth and reducing and/or eliminating plaque without many of the side effects associated with the prior art, such as discoloration of teeth or tongue, desquamation and soreness of oral mucosa, objectionable taste, toxicity and imbalance of the oral flora. For example, chlorhexidine is know to stain teeth, and has been know to cause tissue necrosis of the tongue and gums which may persist in tissue. Also, while chlorhexidine has good antibacterial qualities, it has poor cleansing qualities. Hydrogen peroxide has poor antibacterial properties but works very well by using bursts of oxygen to flush out debris and cleanse. SUMMARY OF THE INVENTION [0005] This invention relates to the treatment of teeth and gums. An object of the invention is to provide a composition for treating teeth, for the removal of plaque and caries, and for the prevention of the build-up of calculus. [0006] It is an object of the present invention to provide a novel composition which is useful in cleansing and brightening teeth and in the treatment of plaque and gingivitis without many of the adverse side effects associated with other compositions. It is another object of this invention to provide dental compositions which would cause little or no ecological imbalance of the oral flora. It is a further object of this invention to provide a composition comprising a combination of acetic acid and conventional tooth paste ingredients wherein this composition possesses improved anti-plaque, anti-gingivitis, and cleansing activity. [0007] Another object is to provide a method for treating teeth which removes plaque and caries, without damaging the teeth. [0008] Yet another object is to provide a method of treating teeth by dissolving away or dispersing plaque and caries, thus essentially eliminating the need for mechanical removal. [0009] The composition of the present invention can be delivered in common dental products such as tooth pastes or dentifrices, tooth powders, mouthwashes, dental floss, toothpicks, chewing gum and the like. [0010] The dental product of the present invention cleans and brightens/whitens teeth. It is also suitable for the treatment of gum disease. It is equally well suited for the prevention of caries, calculi and tartar formation as well as to help remove them. [0011] By addition of a suitable carrier, e.g., a thickening agent, such as colloidal silica, to form a paste, the solution may be more readily applied with an applicator such as a toothbrush or the like. Such a paste may contain other conventional additives such as an abrading agent such as calcium phosphate, calcium carbonate, magnesium carbonate, etc. The dentifrice composition of the present invention can include various other additives which are commonly employed in dentifrices and are well known in the art. [0012] The composition of the present invention need not to be in semi-solid or solid form, i.e., paste or powder, but can be equally used as a solution to be brought adequately into contact with the teeth for a sufficient period of time to enable the plaque and caries to be dissolved and the teeth to be cleansed and brightened, e.g., as a conventional mouth rinse or mouth wash. [0013] The present invention also includes a method of treating teeth in dentistry, for the prevention of calculus, and/or the removal of caries, and/or the dissolving of plaque, and/or brightening/whitening teeth, comprising bringing into contact with the teeth a composition comprising acetic acid and preferably, a preparation containing conventional tooth paste or dentifrice ingredients. Conventional ingredients include, but are not limited to colorants, abrasives and polishing agents, flavoring agents, sweeteners, buffers, diluents, surfactants, gum, sodium fluoride, glycerol, chelating agents, and other ingredients well-known as dental additives and carriers. [0014] The preferred dental product of the present invention contains acetic acid. Preferably the composition also contains sodium hexametaphosphate. By way of example, a suitable acetic acid solution is about 1% to 2%. In accordance with the scope of this invention, the pH of the solution should be maintained between 4 and 7 inclusive. Preferably, the pH is 5.5±1, more preferably, the pH is about 5.0. In order to maintain the preferred pH range it is desirable to add a buffer system to the dental composition. Such a buffer is preferably compatible with the preferred compounds, that is, it should not have any negative effect on same, and should be non-toxic. DETAILED DESCRIPTION OF THE INVENTION [0015] The dental product of the present invention is a tooth gel/dentifrice that cleans and brightens/whitens teeth. However, the instant dental product can also be a mouth wash, a paste, a gel, a dental pack, or dental floss. It may also be used to treat gum disease. It is equally well suited to prevent caries, calculi and tartar formation as well as to help remove them. [0016] The dental product of the present invention contains acetic acid. Preferably the composition also contains sodium hexametaphosphate. [0017] Examples of some acids which may be used according to the present invention instead of or in addition to acetic acid are phosphoric acid, boric acid, hydrochloric acid, maleic acid, benzoic acid, citric acid, lactic acid, malic acid, oxalic acid, tartaric acid, succinic acid, glutaric acid, glycolic acid, gentisic acid, valeric acid, gallic acid, beta- resorcylic acid, acetyl salicylic acid, salicylic acid, perchloric acid, barbituric acid, sulfanilic acid, phytic acid, p-nitro benzoic acid, stearic acid, palmitic acid, oleic acid, myristic acid, lauric acid ethylenediaminetetraacetic acid (EDTA), ethylene glycol-bis{beta-aminoethyl ether}-N,N,N′,N′-tetraacetic acid, and diethylenetriamine pentaacetic acid and the like. The most preferred salts are those of acetic acid but any pharmaceutically acceptable salts of the above acids are equally suitable [0018] In the compositions of this invention, acetic and other organic acids are present preferably in an amount ranging from about 0.001% to about 5.0% by weight of the total composition; more preferably from about 0.01% to about 3.0%; most preferably from about 0.05% to about 1.2%, even more preferably from about 0.08 to about 1.0%. [0019] The desired pH range achieved by the content of acid in the composition is between 4 and 7 inclusive. Preferably, the pH is 5.5±1, more preferably, the pH is about 5.0. In order to maintain the preferred pH range in some occasions it can be desirable to add a buffer system to the dental composition. The selection of the buffer is well known in the art and the buffer is preferably compatible with the other ingredients, that is, it should not have any negative effect on same, and should be non-toxic. [0020] The present invention successfully cleans and brightens teeth while inhibiting and reducing the growth of plaque bacteria, which is achieved when acetic acid or other equivalent organic acid is utilized in combination with conventional dental ingredients in effective concentrations to treat the oral cavity. Small quantities of this unexpectedly simple and nevertheless active component is required to obtain effective inhibition of plaque and other bacteria. Since low quantities of active component can be used in the compositions of this invention, the side effects associated with use of the present invention is correspondingly reduced or eliminated. [0021] Microorganisms that may be eliminated by the present composition and methods include but are not limited to Candida albicans, Cryptococcus neoformans, Aspergillus fumigatus, Candida krusei, Candida parapsilosis, Candida tropicalis , Malassezia species, Trichophyton rubrum , Epidermophyton species, Microsporum species, Sporothrix species, Blastomyces dermatitidis, Coccidiodes immiitis, Histoplasma capsulatum, Staphylococcus aureus, Streptococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, Enterobacter aerogenes, Klebsiella pneumoniae, Staphylococcus epidermis, Zanthomonus maltrophilia, Acinetobacter, Enterobacter cloacae, Serratia marscens , Listeria, Monocytogenes, Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumonia, Viridans streptococci, Haemophilus influenzae, Proteus mirabills, Proteus vulgaris and Bacterioides fragilis among many others. [0022] In one form of this invention, the composition may be a liquid such as a mouthwash or rinse. In such a composition the vehicle is typically a water-alcohol mixture. Generally the ratio of water to alcohol is in the range of from about 1:1 to about 20:1, preferably about 3:1 to about 20:1 and most preferably about 3:1 to about 10:1 by weight. The most preferred mouthwash or mouth rinse compositions comprise from 0 to about 30% by weight alcohol, such as ethanol. The total amount of water-alcohol composition in a mouthwash composition is typically in the range from about 70% to about 99.9% by weight of the composition. The pH value of such a mouthwash composition is generally from about 4.0 to about 7.0 and preferably from about 5 to about 6.5. A pH below 4 would be irritating to the oral cavity. A pH greater than 7 would result in an unpleasant feel. [0023] Oral liquid compositions may also contain surface active agents in amounts up to about 5% and fluorine-providing compounds in amounts up to about 2% by weight of the composition. [0024] The composition also comprises chelating agents, including but not limited to, ethylenediaminetatraacetic acid, edetate sodium, edetate disodium, edetate trisodium, edetate calcium disodium, deferoxamine, ditiocarb sodium, aluminum salts, citric acid-sodium salt, gluconic acid-sodium salt, tartaric acid, sodium hexametaphosphate, anthranilic acid, phosphonate, polyacrylic acid, alkyl-diamine polyacetic acids and salts, penicillamine, pentetic acid, succimer and trientine. The preferred chelator is sodium hexametaphosphate. These chelators are especially useful in preventing and dissolving calculus build-up. [0025] Surface active agents are organic materials which afford complete dispersion of the composition throughout the oral cavity. The organic surface active material may be non-ionic, amphoteric, or cationic. [0026] Preferred non-ionic surface active agents include condensates of sorbitan mono-oleate with from 20 to 60 moles of ethylene oxide (e.g., “Tweens” a trademark of ICI United States, Inc.), condensates of ethylene oxide with propylene oxide and condensates of propylene glycol (“Pluronics” a trademark of BASF-Wyandotte Corp.). [0027] Other suitable non-ionic surfactants are the condensation products of an alpha-olefin oxide containing 10 to 20 carbon atoms, a polyhydric alcohol containing 2 to 10 carbons and 2 to 6 hydroxyl groups and either ethylene oxide or a heteric mixture of ethylene oxide and propylene oxide. The resulting surfactants are heteric polymers having a molecular weight in the range of about 400 to about 1600 and containing 40% to 80% by weight of ethylene oxide, with a alpha-olefin oxide to polyhydric alcohol mole ratio in the range of about 1:1 to 1:3. [0028] Amphoteric surfactants useful in the present invention are zwitterions having the capacity to act as either an acid or a base. They are generally non-irritating and non-staining. Non-limitative examples of suitable amphoteric surfactants include cocoamidopropyldimethylsultaine and cocodimethylbetaine (commercially available from Lonza Chem. Co. under the trade-names Lonzaine CS and Lonzaine 12C, respectively). [0029] Cationic surface active agents are molecules that carry a positive charge such as the quaternary ammonium compounds and are well know to those of skill in the art. [0030] A fluorine providing compound may be present in the oral compositions of this invention. These compounds may be slightly water soluble or may be fully water soluble and are characterized by their ability to release fluoride ions or fluoride containing ions in water. Typical fluorine providing compounds are inorganic fluoride salts such as soluble alkali metal, alkaline earth metal, and heavy metal salts, for example, sodium fluoride, potassium fluoride, ammonium fluoride, cuprous fluoride, zinc fluoride, stannic fluoride, stannous fluoride, barium fluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium fluorozirconate, sodium monofluorophosphate, aluminum mono-and difluorophosphate and fluorinated sodium calcium pyrophosphate. [0031] In an oral liquid composition such as a mouthwash, the fluorine providing compound is generally present in an amount sufficient to release up to about 0.15%, preferably about 0.001% to about 0.05%, fluoride by weight of the composition. [0032] The compositions of this invention may be substantially solid or pasty in character such as dental cream, toothpaste, toothpowder or chewing gum. Such solid or pasty oral compositions may also contain polishing materials. Typical polishing materials are abrasive particulate materials having particle sizes of up to about 20 microns. Nonlimiting illustrative examples include water-insoluble sodium metaphosphate, potassium metaphosphate, tricalcium phosphate, dehydrated calcium phosphate, anhydrous dicalcium phosphate, dicalcium phosphate, calcium pyrophosphate, magnesium orthophosphate, trimagnesium phosphate, calcium carbonate, alumina, aluminum silicate, zirconium silicates, silica, bentonite, and mixtures thereof. Polishing materials are generally present in an amount from about 20% to about 99% by weight of the composition. Preferably, such materials are present in amounts from about 20% to about 75% in toothpaste, and from about 70% to about 99% in toothpowder. [0033] In clear gels, a polishing agent of colloidal silica and alkali metal aluminosilicate complexes are preferred since they have refractive indices close to the refractive indices of gelling agent liquid systems commonly used in such dentifrices. [0034] The compositions of the present invention may additionally contain sweeteners, flavorants and colorants. [0035] In the instance where auxiliary sweeteners are utilized, the present invention contemplates the inclusion of those sweeteners well known in the art, including both natural and artificial sweeteners. Water-soluble sweetening agents such as monosaccharides, disaccharides and polysaccharides such as xylose, ribose, glucose, mannose, galactose, fructose, dextrose, sucrose, maltose, partially hydrolyzed starch, or corn syrup solids and sugar alcohols such as sorbitol, xylitol, mannitol and mixtures thereof. Without limiting to these examples, water-soluble artificial sweeteners such as the soluble saccharin salts, i.e., sodium, or calcium saccharin salts, cyclamate salts, acesulfame-K and the like, and the free acid form of saccharin are equally suitable. Other sweeteners such as dipeptide based sweeteners such as L-phenylalanine methyl ester and materials described in U.S. Pat. No. 3,492,131 (herein incorporated by reference) and the like are equally suitable. [0036] In general, the amount of sweetener will vary with the desired amount of sweetness selected for a particular composition. This amount will normally be 0.01% to about 40% by weight. The water-soluble sweeteners are preferably used in amounts of about 5% to about 40% by weight, and most preferably from about 10% to about 20% by weight of the final composition. In contrast, the artificial sweeteners described are preferably used in amounts of about 0.005% to about 5.0% and most preferably about 0.05% to about 2.5% by weight of the final composition. These amounts are ordinarily necessary to achieve a desired level of sweetness independent from the flavor level achieved from flavorants. [0037] Suitable flavorings include both natural and artificial flavors, and mints such as peppermint, citrus flavors such as orange and lemon, artificial vanilla, cinnamon, various fruit flavors and the like. In one embodiment the flavoring agent comprises cinnamon-clove beads. Such beads can be additionally filled with fillers consisting of inert materials or medicinal agents such as vitamins or antibacterial agents. Both individual and mixed flavors are contemplated. The flavorings are generally utilized in amounts that will vary depending upon the individual flavor, and may, for example, range in amounts of about 0. 1% to about 6% by weight of the final composition. [0038] The colorants useful in the present invention, include the pigments which may be incorporated in amounts of up to about 2% by weight of the composition. Also, the colorants may include other dyes suitable for food, drug and cosmetic applications, and known as FD & C dyes and the like. The materials acceptable for the foregoing uses are preferably water-soluble. Illustrative examples include the indigo dye, known as FD & C Blue No. 2, which is the disodium salt of 5,5-indigotindisulfonic acid. Similarly, the dye known as FD & C Green No. 1, comprises a triphenylmethane dye and is the monosodium salt of 4-[4-N-ethyl-p-sulfobenzyl amino)diphenylmethylene]-[1-(N-ethyl-N-p-sulfoniumbenzyl)-2,5-cyclohexadie nimine]. A full recitation of all FD & C and D & C colorants useful in the present invention and their corresponding chemical structures may be found in the Kirk-Othmer Encyclopedia of Chemical Technology, 3rd Edition, in Volume 6, at pages 561-595, which text is accordingly incorporated herein by reference. [0039] A medicated dental floss for controlling the bacterial activity associated with gingivitis is also contemplated. The floss incorporates acetic acid which, as a result of the flossing action, is deposited to the inter-dental area of the teeth. The slow dissolution of the antimicrobial agent ensures that effective levels of medication are attained for sustained periods, thereby reducing bacterial activity. Examples of making such floss are well known and are disclosed for example in U.S. Pat. No. 5,603,921 herein incorporated by reference. [0040] The present invention also involves a method for treating teeth or gums to reduce plaque or gingivitis comprising applying to the surface of the teeth and/or gums the compositions of this invention as described above. The compositions can be applied to the teeth and gums by any conventional means such as brushing, spraying, painting or rinsing of the oral cavity and the like. The compositions not only cleans and brightens the teeth and retards plaque accumulation, but has been demonstrated to remove pre-existing plaque as well. Additionally, the compositions show a prolonged effect on plaque accumulation following cessation of treatment for at least about one week after use. This property is especially useful in veterinary applications where animals are not necessarily treated on a daily basis, but where longer intervals of time occur between treatments. [0041] The compositions of this invention are also useful as a topical antiseptic, disinfectant or antibacterial which is applied externally to the skin around the mouth or oral cavity. The composition can be delivered in form of a cream, lotion, lip balm, lipstick, or other art-known forms of carriers. [0042] Other uses and applications for compositions prepared according to the present invention will be apparent to those skilled in the art. Preferred uses include, but are not limited to, formulations for oral use such as a mouthwash or dentifrice, mouth rinses (including swish and swallow preparations). Other preferred formulations for topical use are contemplated which include, but are not limited to, skin sanitizers, surgical scrubs and preparations, handwashs and towlettes; formulations for treatment of infections of the skin or mouth area in a human; veterinary medicament for animal skin, hooves, claws, fur, or teeth; nail paints and polishes; skin preparations; and footwear inserts. [0043] The following examples are presented to further illustrate this invention. The examples are intended in an illustrative sense and not in a limitative sense. The present invention includes the embodiments described and shown and any equivalents thereof. All parts and percentages are on a weight basis unless otherwise indicated. EXAMPLE 1 [0044] [0044] Tooth Paste Abrasive Powder 12.9 Calcium phosphate 25.0 Acetic acid 1.0 Carrageenan 1.0 Glycerin 10.0 Sorbitol 15.0 Sodium lauryl sulfate 2.0 Flavor 1.0 Sodium saccharinate 0.1 Silicon dioxide 2.0 Water 30.0 EXAMPLE 2 [0045] [0045] Tooth Powder Abrasive powder 95.3 Sodium lauryl sulfate 2.0 Acetic acid 1.0 Flavor 1.5 Sodium saccharinate 0.2 EXAMPLE 3 [0046] [0046] Wet Tooth Powder Abrasive powder 64.38 Calcium phosphate 10.0 Sorbitol 10.0 Sodium lauryl sulfate 2.0 Acetic acid 1.0 Flavor 1.5 Calcium phosphate 1.0 Water 10.0 Sodium saccharinate 0.12 EXAMPLE 4 [0047] [0047] Mouthwash Acetic acid 1.0 Nonionic surfactant 0.7 Sorbitol solution 50.0 Ethanol (95% in water) 10.0 Coloring agent 0.0004 Flavoring agent 0.15 Water to 100% EXAMPLE 5 [0048] [0048] Dentifrice Acetic acid 3.0 Sodium fluoride  0.24 Hydrated silica 10-50 Xylitol 10-40 Xanthan gum 0.1-1.5 Cocobetaine 0.1-1.5 Flavoring agent 0.9 Water to 100% EXAMPLE 6 [0049] [0049] Oral spray Citric acid; hydrous 1.0 Nonionic surfactant 1.2 Ethanol 12.0 Glycerol 20.0 Sweetening agent 0.01 Flavoring agent 0.10 Water to 100% EXAMPLE 7 [0050] [0050] Chewing Gum (per stick) Estergum 142 mg Coumarone Resin 213 mg Latex  71 mg Paraffin Wax  47 mg Sorbitol 1309 mg  Corn Syrup 400 mg Flavoring q.s. Sodium Bicarbonate 0.2-43 mg Sodium Chloride 0.3-23 mg Sodium Thiocyanate 0.4-32 mg Sodium Fluoride 0.2-16 mg Ascorbic Acid  10 mg Acetic Acid  10 mg EXAMPLE 8 [0051] [0051] Breath freshener tablet Wintergreen Oil  0.6 mg Talc 10.0 mg Menthol 0.85 mg Peppermint Oil  0.3 mg Sodium Saccharin  0.3 mg Mannitol USP 180.95 mg  Sodium Stearate  2.0 mg Sodium Bicarbonate 0.2-43 mg Sodium Chloride 0.3-23 mg Sodium Thiocyanate 0.4-32 mg Sorbitol USP 180.0 mg  Lactose USP q.s. 1 gm Sodium Flouride 0.2-16 mg Acetic acid   2 mg EXAMPLE 9 [0052] [0052] Chewable multivitamin tablet Vitamin A 5000 USP units Vitamin D  400 USP units Ascorbic Acid   60 mg Thiamine HCl   1 mg Riboflavin  1.5 mg  Pyridoxine HCl   1 mg Cyanocobalamin   2 mcg Calcium Pantothenate   3 mg Niacinamide   10 mg Mannitol  236 mg Corn Starch 16.6 mg Sodium Saccharin  1.1 mg Sodium Stearate  6.6 mg Talc   10 mg Wintergreen Oil  1.2 mg Menthol  1.7 mg Peppermint Oil  0.6 mg Sodium Bicarbonate 0.2-43 mg Sodium Chloride 0.3-23 mg Sodium Thiocyanate 0.4-32 mg Sodium Fluoride 0.2-16 mg Acetic acid   22 mg EXAMPLE 10 [0053] [0053] Veterinary, e.g., dog, tooth gel Water 65.95 SD Alcohol 40-B 18.00 Sorbitol 10.00 PVM/MA Decadiene Crosspolymer 1.80 Acetic acid 1.00 C11-15 Pareth-12 1.00 Flavor 0.50 Methylparaben 0.20 Lactose (and) Cellulose (and) 0.10 Hydroxypropyl Methylcellulose (and) Chromium Hydroxyde Green (and) Tocopheryl Acetate Lactose (and) Cellulose (and) 0.10 Hydroxypropyl Methylcellulose (and) Ultramines (and) Tocopheryl Acetate (and) Retinyl Palmitate Lactose (and) Cellulose (and) 0.10 Hydroxypropyl Methylcellulose (and) Iron Oxide and Tocopheryl Acetate Triethanolamine 1.10 Sodium Benzoate 0.10 Sodium Hexametaphosphate 0.05 EXAMPLE 11 [0054] A solution of 0.1% of Neutral Red is applied to the front teeth of each of two male adults A and B who had been using conventional commercially available dentifrice. Thereafter, a similar dyeing operation is conducted one day after they began to use the dentifrice of Example 1 and the plaque-stained areas before and after the use of the dentifrice of Example 1 is compared. In the case of A, the stained area after the change is about only 10% of the initial stained area indicating that the decontamination of the plaque area is about 90%. In the case of B the decontamination of the plaque area is about 50% superior to conventional dentifrice. These beneficial effects result from the twice-daily application of about 5 to 25 gram of the dentifrice of Example 1. Similar beneficial results are obtained when a third subject rinsed the mouth with about 50 to 100 ml of mouthwash of Example 4. EXAMPLE 12 [0055] Minimum inhibitory concentration studies are performed using the gram-negative enterobacterium Pseudomonas aerugenosa (American Type Culture Collection #9027) in accordance with the protocol for testing the bactericidal activity of antimicrobial agents (Document M26-T of the National Center for Clinical and Laboratory Standards). P. aeruienosa is cultured overnight at 37° C. in trypsin soy broth to a final density of approximately 1×10 8 cfu/ml (0.5 McFarland standard) and then diluted 1:10 with cation-adjusted Mueller-Hinton medium. 10 microliters of this bacterial culture is then added to 200 microliters of an already-prepared dilution series of the test solution (Composition of Example 4). After a 5 minute incubation at room temperature, 10 microliters of wash test solution is plated onto a sector of a Letheen-agar plate and incubated at 37° C. overnight. MIC breakpoint is interpreted as the highest dilution for which no growth is evident. The results show that Compositions of Example 4 are far more effective in vitro at inhibiting the growth of P. aerugenosa than the control solution, which contains the USP benzalkonium chloride mixture. [0056] The invention has been described with respect to certain preferred embodiments but it will be understood that variations and modifications may be made therein without departing from the spirit of this invention and the scope of the appended claims.

1a

The present application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61/632,263 filed on Jan. 23, 2012. FIELD OF THE INVENTION The invention is in the medical field, and is particularly useful in percutaneous procedures such as embolization. BACKGROUND OF THE INVENTION In certain medical procedures, such as blood vessel embolization, it is desired to inject particles into the body. The procedure is a minimally invasive alternative to surgery. The purpose of embolization is to prevent blood flow to an area of the body, which effectively can shrink a fibroid, such as a uterine fibroid. It can also shrink a tumour or block an aneurysm. It is typically done by injecting blocking particles into a blood vessel. The procedure is carried out as an endovascular procedure by a radiologist in an interventional suite. It is common for most patients to have the treatment carried out with little or no sedation, although this depends largely on the organ to be embolized. Access to the organ in question is acquired by means of a guidewire and catheter. The position of the correct artery or vein supplying the undesired tissue in question is located by X-Ray images. These images are then used as a map for the radiologist to gain access to the correct vessel by selecting an appropriate catheter and or wire, depending on the shape of the surrounding anatomy The blocking particles are mixed into a saline solution, sometimes a contrast agent is added (to make the solution opaque to X-Rays). The blocking particles have to be of certain sizes, typically between 0.1 mm to 1 mm, in order to block the blood vessel at the right diameter. Such particles tend to settle very quickly out of the solution as they are heavier than water, causing an uneven concentration of particles during the injection. The settling occurs in as little as a few seconds. It is inconvenient to keep shaking the syringe used for injection, as the whole process is performed in a few seconds and the doctor has to concentrate on injecting the correct amount. It is desired to have a syringe that can keep the particles uniformly dispersed in the saline solution regardless of delays in the injection process or speed of the injection. Since the syringes used are low cost disposable items, it is desired that the device used to keep the particles uniformly dispersed will also be very low cost and disposable. The ideal mixing syringe needs the following attributes: A. Ability to be re-filled multiple times during a procedure. This rules out any single-use designs, typically using the rupturing of a membrane to allow mixing. B. Generate a strong mixing action, preferable by creating a vortex in the mixture. C. Use the minimum modification to a standard syringe. Prior art mixing syringes, such as disclosed in U.S. Pat. No. 7,883,490 are designed to mix together two materials stored separately in two compartments. They are not designed to stir up a pre-mixed solution. Prior art syringes designed to stir-up embolization mixtures, such as disclosed in US2009/0247985, are needlessly complex. Also, many of the prior art mixing syringes are not designed to be filled with the pre-mixed solution just before use. This is required during embolization, as the correct volume and ratio of saline, particles and contrast agent has to be customized to the procedure by the doctor. The current invention acts as a regular syringe, allowing filling and injecting at any time, but it keeps the solution stirred up during injection. Similar to a regular syringe, it can be re-used several times during a procedure, if more particles have to be injected. The invention can be manufactured out of a regular syringe, which is a very low cost item. SUMMARY OF THE INVENTION A movable mixing disc is inserted into a regular syringe. The mixing disc has a small hole covered by a fine screen, allowing only saline solution to get behind disc. When the plunger of the syringe is pressed, the saline solution emerges from the mixing disc hole as a high velocity jet, stirring up the settled particles. As the ejection continues, the mixing disc is pushed forward by the plunger in order to eliminate any unused volume. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a general view of the invention. FIG. 2A shows a cross section of the mixing disc. FIG. 2B shows a front view of the mixing disc of FIG. 2A . FIG. 3 shows the action of the mixing disc. FIG. 4A is a cross section of a mixing disc stamped out of sheet metal. FIG. 4B is a front view of the mixing disc of FIG. 4A . FIG. 5 shows a version of the invention not requiring modifications to the syringe. DETAILED DESCRIPTION Referring now to FIG. 1 , the mixing syringe is a regular syringe with the addition of a mixing disc. A syringe 1 includes a plunger 2 and a seal 3 in order to eject the liquid 6 via tube 4 . A piston-like mixing disc 5 a is added into the syringe. The initial position of disc 5 a is shown as 5 a ′, with plunger seal 3 touching disc 5 a . As liquid and particles are sucked into syringe 1 , seal 3 moves farther from disc 5 a to create a vacuum. Disc 5 a moves as well, until stopped by slight ridge 8 . The size of the ridge is exaggerated in FIG. 1 for clarity. It only needs to reduce the inside diameter by about 0.2-0.3 mm. Flexible seal 3 easily passes over such a ridge. The particles 7 are sucked into the syringe via tube 4 and quickly settle as shown in FIG. 1 . The particles do not accumulate in the section between plunger seal 3 and disc 5 a as disc 5 a includes a filter with pore sizes smaller than the particles. This is shown in FIGS. 2A and 2B . Disc 5 a has one or more holes 9 covered by filter mesh 10 . It is desired to chamfer hole 9 under screen 10 to increase the effective area of the screen. The screen can also be mounted as a flexible flap, being pushed out of the way during ejection of the fluid. The conical shape of disc 5 a is matched to the shape of the conical seal 3 and the conical tip of the syringe. This eliminates trapped fluid between the seal 3 and the syringe outlet at the end of the stroke. The conical shape of disc 5 a also aids the removal of any trapped air bubbles, as they float to the top of disc 5 a and escape when syringe is held vertically. As plunger 3 is moved towards disc 5 a the liquid 6 is ejected via hole 9 at a high velocity, mixing up particles 7 and liquid 6 . This is shown in FIG. 3 . From the moment seal 3 touches disc 8 the disc is pushed forward towards the tube 4 until the syringe is empty and disc 5 a is in position 5 a ′. The operation can now be repeated, if desired. It is desirable to make hole 9 at an angle to the axis of the syringe in order to create a vortex 111 . An even more effective vortex 111 can be created if hole 9 is molded as a curved arc, both in the plane of the drawing and also in the plane perpendicular to the drawing. Disc 5 a can be molded in one piece, including screen 10 . Alternatively, screen 10 can be bonded to molded disc 5 a . The fit between disc 5 a and bore of syringe 1 is not critical as the particles are relatively large. It was found out that for best results the diameter of disc 5 a should be 0.1-0.2 mm smaller than the inside diameter of syringe 1 . While the example given is for embolization, the invention can be used to mix and two components, including two liquids. The disc 5 can also be made out of pressed sheet metal 11 . This is shown as disc 5 b in FIGS. 4A and 4B . In this case hole 9 and screen 10 are replaced by miniature stamped louvers 12 (similar to a miniature venetian blind) acting both as a screen and as a flow director. Recommended material is type 316L stainless steel or aluminum, with thickness between 0.1 to 0.3 mm. The thin wall allows seal 3 to enter into the hollow disc and squeeze out all the liquid. In order to eliminate the need of molding custom syringes it was found out that the slight ridge 8 can be formed in existing syringes by briefly heating up the area of ridge 8 and pressing the walls in slightly, using a split ring slightly smaller than the outside diameter of the syringe. Other ways of creating a ridge without molding is pressing into the syringe a thin walled ring, held by friction. If desired the invention can be manufactured out of a standard disposable syringe, without any modifications. The movable disc 5 a is attached to the outlet side of the syringe with a short string that only allows it to move a limited distance. The string 13 is bonded by heat to the syringe or uses an anchor 14 . This is shown in FIG. 5 . In operation tube 4 is first inserted into a mixing bowl where the ingredients are mixed together. The mixture is sucked into the syringe. After filling the syringe is held vertically to help trapped air escape and plunger moved to expel all air. Afterwards tube 4 is moved to the catheter or needle used for the procedure and mixture is injected. An additional improvement in mixing is to adjust the density of particles 7 to match the density of liquid 6 , typically a saline solution with a density around 1 . since the materials used to make particles 7 (plastic, glass or ceramic) have a density greater than 1 , they have to be made hollow. The technology of manufacturing small hollow spheres, known as micro-balloons, is well known and many polymers as well as glasses are commercially available in micro-balloon form. One supplier is Henkel (http://www.henkelna.com/cps/rde/xchg/henkel_us/hs.xsl/brands-1556.htm?iname=Dualite%25C2%25AE&countryCode=us&BU=industrial&parentredDotUID=0000000GFR&redDotUID=0000000GFR&brand=000000QTQE Both ideas can be combined: micro-balloon shaped polymer or glass spheres with a density around 1 can be dispensed from a syringe with a mixing disc.

1a

FIELD OF THE INVENTION [0001] The present invention pertains generally to ophthalmic diagnostic equipment. More particularly, the present invention pertains to systems and methods for imaging retinal tissue. The present invention is particularly, but not exclusively, useful as a system and method for stimulating tissue with a light beam of ultra-short pulses having an input wavelength that generates a return beam having different wavelength components depending on the type of retinal tissue being imaged. BACKGROUND OF THE INVENTION [0002] Effective imaging of the retina of an eye depends on the type of retinal tissue that is to be imaged, as well as the optical response of that tissue to the input light beam. In particular, for two specific tissues of the retina, namely the Retina Pigment Epithelium (RPE) and the Lamina Cribrosa (LC), it happens there are two different optical phenomena that generate the particular tissue's response. One is known as Two Photon Excited Fluorescence (TPEF). This phenomenon is efficacious for imaging the RPE of the retina. The other phenomenon is Second Harmonic Generation (SHG), which is efficacious for imaging the LC. An ability to image these tissues (i.e. RPE or LC) depends on how these phenomena are exploited. [0003] Anatomically, RPE tissue in the retina includes the protein, lipofuscin. In the context of the present invention, it is known that lipofuscin is susceptible to TPEF. Specifically, it can be demonstrated that when an input beam of red light (e.g. λ i =780 nm) is incident on lipofuscin in the RPE, a resultant return beam of fluorescent green light (e.g. λ r1 =530 nm) is generated. On the other hand, when this same input beam of red light (λ i ) is incident on the LC there is a much different response. Specifically, as a result of SHG, a return beam of blue light (e.g. λ r2 =390 nm) is generated. (Note: λ i ≠λ r1 ≠λ r2 ). Nevertheless, both of the return beams (λ r1 and λ r2 ) are useable for effectively imaging the respective tissues. [0004] During an imaging procedure, it happens that the anterior components of the eye (i.e. the cornea and the lens) will introduce optical aberrations into the input light beam. Also, the retina will introduce optical and phase aberrations. These aberrations, both optical and phase aberrations, are measurable. Furthermore, using adaptive optics with a wavefront sensor, the input light can be altered to effectively compensate for any optical aberrations that may be present. Further, phase aberrations that are introduced by curvature of the retina can be compensated for by pre-programming input to a computer that controls the adaptive optics. [0005] In light of the above, it is an object of the present invention to provide a system and method that is capable of alternatively imaging the RPE or the LC tissues in a retina of an eye. Another object of the present invention is to provide a system and method that is capable of selectively exploiting the TPEF or SHG phenomenon to image different tissue in the retina of an eye. Yet another object of the present invention is to provide a system and method for imaging selective tissue in the retina of an eye that is easy to implement, is simple to use and is comparatively cost effective. SUMMARY OF THE INVENTION [0006] A system and method for imaging tissue in the retina of an eye includes a laser unit for generating an ultra-short pulsed input light beam having a wavelength (λ i ). As envisioned for the present invention, when the input light beam (λ i ) is incident on a target tissue, the tissue will generate a return light beam (λ r ). Importantly, this return light beam will include different wavelength components (i.e. λ r1 and λ r2 ) depending on the nature of the target tissue. In accordance with the present invention, this return light beam is then used for two different purposes. For one, regardless of wavelength, the return beam includes information that can be used to compensate for optical and phase aberrations that are introduced into the input beam by the eye. For another, depending on which component of the return beam is predominant (i.e. λ r1 vis-a-vis λ r2 ) the selected component can be used to image the particular retinal tissue that generates the return light beam. [0007] Structurally, along with the laser unit that is used for generating the input light beam, the system for the present invention also includes a sensor with adaptive optics. For the present invention, the sensor has a wavefront sensor for measuring optical aberrations (e.g. a Hartmann Shack sensor) that is electronically connected with an active mirror. Together, the wavefront sensor and the active mirror are employed to alter the input light beam in a manner that will compensate for optical and phase aberrations introduced into the input beam. The system also includes a detector that receives the return light beam and uses it for imaging the target tissue that has been illuminated by the input beam. [0008] For imaging purposes, the present invention directs the input light beam onto the target tissue that is to be imaged (e.g. RPE or LC). Preferably the input light beam is red light having a wavelength of about λ i =780 nm. In the case of the RPE, because the target tissue includes lipofuscin, the tissue responds with TPEF by generating a return beam of green fluorescent light (λ r1 =580 nm). In the case of the LC, however, the target tissue responds with SHG by generating a return beam of blue light (λ r2 =390 nm). In each case, regardless of the type tissue being imaged, the return light is received by the detector for subsequent imaging of the tissue. BRIEF DESCRIPTION OF THE DRAWINGS [0009] The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which: [0010] FIG. 1 is a schematic view of the components of a system for the present invention; [0011] FIG. 2 is a cross sectional view of a portion of a retina of an eye; [0012] FIG. 3 is an enlarged view of retinal tissue (i.e. RPE) in the area bounded by the line 3 - 3 in FIG. 2 ; [0013] FIG. 4 is an enlarged view of retinal tissue (i.e. LC) in the optical nerve head; and [0014] FIG. 5 is a schematic of the aberration compensation mechanism of the system. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0015] Referring initially to FIG. 1 , a system in accordance with the present invention is shown and is generally designated 10 . More specifically, as shown, the system 10 includes a laser unit 12 for generating an input laser beam 14 . For the present invention, the input laser beam 14 is preferably a pulsed laser beam wherein the pulses are ultra-short and each pulse has a duration measured in femto-seconds. Further, the input laser beam 14 preferably has a wavelength (λ i ) that is about 780 nm (λ i =780 nm). FIG. 1 also indicates that the input laser beam 14 is directed from the laser unit 12 , and onto the retina 16 of an eye 18 . As intended for the present invention, when the input light beam 14 (λ i ) is incident on tissue in the retina 16 , it will interact with the tissue to generate a return light beam 20 . Importantly, the return light beam 20 may include either, or both, of two different components that will have different wavelengths. Stated differently, the return light beam 20 will include a first component having a wavelength (λ r1 ) and a second component with a wavelength (λ r2 ). Note: λ i ≠λ r1 ≠λ r2 . [0016] Still referring to FIG. 1 it will be seen that, in addition to the laser unit 12 , the system 10 includes a sensor unit 22 and an active mirror 24 . Specifically, these elements of the system 10 (i.e. sensor unit 22 and active mirror 24 ) are used to pre-compensate the input beam 14 to create a diffraction limited spot on the retina 16 . On this point it is well known that the cornea 26 and lens 28 of the eye 18 will introduce optical aberrations into the input light beam 14 . Also, the retina 16 will introduce phase aberrations that continue with the return light beam 20 . In order to measure the optical aberrations, the sensor unit 22 is preferably a wavefront sensor of a type well known in the pertinent art, such as a Hartmann Shack sensor. On the other hand, phase aberrations introduced by the retina 16 are preferably compensated for by pre-programming a computer to account for curvature of the retina 16 . It is known, however, that some phase aberrations can be detected by fluorescence wavefront analysis. Therefore, the sensor unit 22 may also include this capability. [0017] Once optical and phase aberrations in a return light beam 20 have been measured by the sensor unit 22 , the aberrations can then be used to program an active mirror 24 (i.e. the computer used for operation of the active mirror 24 ). Specifically, the active mirror 24 is to be programmed in a manner that will change the input light beam 14 to thereby effectively remove the aberrations from the return light beam 20 . Alternatively, a customized phase plate 29 (see FIG. 5 ) of a type disclosed in co-pending U.S. application Ser. No. 12/204,674 which is assigned to the same assignee as the present invention can be used with, or without, the active mirror 24 for this purpose. Importantly, the now-compensated return light beam 20 can be used by the imaging unit 30 for imaging purposes. [0018] Anatomically, an optic (visual) part 32 of the retina 16 comprises most of what is generally referred to as the fundus. As shown in FIG. 2 , the sclera 34 is under the optic (visual) part 32 , and the optical nerve head 36 connects to the optic (visual) part 32 through the sclera 34 . In detail, with reference to FIG. 2 and FIG. 3 it will be seen that the optic (visual) part 32 of the retina 16 is curved and includes a Retina-Pigment-Epithelium (RPE) 38 . The RPE 38 is a target tissue of interest for the present invention. Anterior to the RPE 38 and identified in an anterior to posterior direction, are: nerve fibers 40 ; retinal ganglion cells 42 ; axion 44 ; bipolar cell 46 ; and a photo receptor 48 . Of these, as indicated above, it is the RPE 38 with its lipofuscins that responds to the input beam (λ i ) to generate a return beam (λ r1 ) 20 due to TPEF. Referring now to FIG. 4 , it will be seen that the optical nerve head 36 anatomically includes the Lamina Cribrosa (LC) 50 which is bounded by pre-laminar tissue 52 and post-laminar tissue 54 . As also indicated above, the LC 50 is also a target tissue of interest for the present invention. In this case, the LC 50 responds to the input beam 14 (λ i ) to generate a return beam 20 (λ r2 ) due to SHG. [0019] Additional aspects of aberration compensation for the present invention can be appreciated with reference to FIG. 5 . There the sensor unit 22 is shown to include a lens array 56 , and a CCD camera 58 . This arrangement is typical for a wavefront sensor of the type commonly referred to as a Hartmann-Shack sensor. FIG. 5 also indicates that a customized phase plate 29 can be used together with, or in lieu of, the active mirror 24 . In either case, the importance of the arrangement is to compensate the input beam 14 for aberrations that could otherwise diminish the efficacy of the imaging system 10 . Anatomically, there are three sources for these aberrations; all from the eye 18 itself. They are: 1] optical aberrations introduced by the anterior segment (i.e. cornea 26 and lens 28 ); 2] phase aberrations introduced by the curvature of the retina 16 that relate to astigmatism; and 3] phase aberrations introduced by the retina 16 . [0020] Of all the aberrations introduced by an eye 18 into the input light beam 14 , optical aberrations are the most prominent, and are measured by the sensor unit 22 . To do this, a source 60 of infrared (IR) light radiates IR through pupil imaging optics 62 . Also, the Internal Limiting Membrane (ILM) 64 that defines the anterior surface of the retina 16 includes aberrational information in the light that is reflected from the retina 16 . After leaving the eye 18 , the optical aberrations that are introduced into the return beam 20 by the cornea 26 and lens 28 are processed by the sensor unit 22 . The resultant information is then programmed into the active mirror 24 . This essentially compensates for the first source of aberrations (i.e. the anterior segments). As for the second source of aberrations (i.e. phase aberrations introduced by the curvature of the retina 16 ) it is well known that these aberrations can be measured in accordance with the angle of incidence, “θ”, between the input light beam 14 and the anterior surface of the retina 16 . Accordingly, “θ” is determined by anatomical dimensions of the retina 16 . The resultant measurements involving “θ” are then also programmed into the computer-controlled active mirror 24 . The remaining aberrations from the third source (i.e. the retina 16 ), although relatively minor, can be detected by a fluorescence wavefront sensor in the sensor unit 22 and used with the other information to further refine compensation corrections for the system 10 . [0021] As mentioned above, and as shown in FIG. 5 , a custom phase plate 29 can be used in combination with the active mirror 24 , or in lieu thereof. In either configuration, the purpose is to pre-compensate the input light beam 14 so that aberrations introduced into the light beam 14 do not detract from the imaging capability of the system 10 . [0022] While the particular System and Method for Imaging Retinal Tissue with Tissue Generated Light as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.

1a

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation application of U.S. patent application Ser. No. 10/783,292, filed Feb. 18, 2004, now allowed, which is a continuation application of U.S. patent application Ser. No. 09/968,047, filed Oct. 1, 2001, entitled “An Intervertebral Spacer Device Having a Radially Thinning Belleville Spring”, the disclosures of which are hereby incorporated by reference herein. FIELD OF THE INVENTION This invention relates generally to a spinal implant assembly for implantation into the intervertebral space between adjacent vertebral bones to simultaneously provide stabilization and continued flexibility and proper anatomical motion, and more specifically to such a device which utilizes a belleville washer having a radially varying thickness profile as a restoring force generating element. BACKGROUND OF THE INVENTION The bones and connective tissue of an adult human spinal column consists of more than 20 discrete bones coupled sequentially to one another by a tri-joint complex which consists of an anterior disc and the two posterior facet joints, the anterior discs of adjacent bones being cushioned by cartilage spacers referred to as intervertebral discs. These more than 20 bones are anatomically categorized as being members of one of four classifications: cervical, thoracic, lumbar, or sacral. The cervical portion of the spine, which comprises the top of the spine, up to the base of the skull, includes the first 7 vertebrae. The intermediate 12 bones are the thoracic vertebrae, and connect to the lower spine comprising the 5 lumbar vertebrae. The base of the spine is the sacral bones (including the coccyx). The component bones of the cervical spine are generally smaller than those of the thoracic spine, which are in turn smaller than those of the lumbar region. The sacral region connects laterally to the pelvis. While the sacral region is an integral part of the spine, for the purposes of fusion surgeries and for this disclosure, the word spine shall refer only to the cervical, thoracic, and lumbar regions. The spinal column of bones is highly complex in that it includes over twenty bones coupled to one another, housing and protecting critical elements of the nervous system having innumerable peripheral nerves and circulatory bodies in close proximity. In spite of these complications, the spine is a highly flexible structure, capable of a high degree of curvature and twist in nearly every direction. Genetic or developmental irregularities, trauma, chronic stress, tumors, and degenerative wear are a few of the causes which can result in spinal pathologies for which surgical intervention may be necessary. A variety of systems have been disclosed in the art which achieve immobilization and/or fusion of adjacent bones by implanting artificial assemblies in or on the spinal column. The region of the back which needs to be immobilized, as well as the individual variations in anatomy, determines the appropriate surgical protocol and implantation assembly. With respect to the failure of the intervertebral disc, the interbody fusion cage has generated substantial interest because it can be implanted laparoscopically into the anterior of the spine, thus reducing operating room time, patient recovery time, and scarification. Referring now to FIGS. 1 and 2 , in which a side perspective view of an intervertebral body cage and an anterior perspective view of a post implantation spinal column are shown, respectively, a more complete description of these devices of the prior art is herein provided. These cages 10 generally comprise tubular metal body 12 having an external surface threading 14 . They are inserted transverse to the axis of the spine 16 , into preformed cylindrical holes at the junction of adjacent vertebral bodies (in FIG. 2 the pair of cages 10 are inserted between the fifth lumbar vertebra (L 5 ) and the top of the sacrum (S 1 ). Two cages 10 are generally inserted side by side with the external threading 14 tapping into the lower surface of the vertebral bone above (L 5 ), and the upper surface of the vertebral bone (S 1 ) below. The cages 10 include holes 18 through which the adjacent bones are to grow. Additional material, for example autogenous bone graft materials, may be inserted into the hollow interior 20 of the cage 10 to incite or accelerate the growth of the bone into the cage. End caps (not shown) are often utilized to hold the bone graft material within the cage 10 . These cages of the prior art have enjoyed medical success in promoting fusion and grossly approximating proper disc height. It is, however, important to note that the fusion of the adjacent bones is an incomplete solution to the underlying pathology as it does not cure the ailment, but rather simply masks the pathology under a stabilizing bridge of bone. This bone fusion limits the overall flexibility of the spinal column and artificially constrains the normal motion of the patient. This constraint can cause collateral injury to the patient's spine as additional stresses of motion, normally borne by the now-fused joint, are transferred onto the nearby facet joints and intervertebral discs. It would therefore, be a considerable advance in the art to provide an implant assembly which does not promote fusion, but, rather, which nearly completely mimics the biomechanical action of the natural disc cartilage, thereby permitting continued normal motion and stress distribution. It is, therefore, an object of the present invention to provide a new and novel intervertebral spacer which stabilizes the spine without promoting a bone fusion across the intervertebral space. It is further an object of the present invention to provide an implant device which stabilizes the spine while still permitting normal motion. It is further an object of the present invention to provide a device for implantation into the intervertebral space which does not promote the abnormal distribution of biomechanical stresses on the patient's spine. Other objects of the present invention not explicitly stated will be set forth and will be more clearly understood in conjunction with the descriptions of the preferred embodiments disclosed hereafter. SUMMARY OF THE INVENTION The preceding objects of the invention are achieved by the present invention which is a flexible intervertebral spacer device comprising a pair of spaced apart base plates, arranged in a substantially parallel planar alignment (or slightly offset relative to one another in accordance with proper lordotic angulation) and coupled to one another by means of a spring mechanism. In particular, this spring mechanism provides a strong restoring force when a compressive load is applied to the plates, and may also permit limited rotation of the two plates relative to one another. While there are a wide variety of embodiments contemplated, two embodiments (and variations of both) are described herein as representative of preferred types. Each of these embodiments includes a spirally slotted and radially varying thickness belleville washer utilized as its restoring force providing element. More particularly, with respect to the base plates, which are similar in all embodiments, as the assembly is to be positioned between the facing surfaces of adjacent vertebral bodies, and as such need to have substantially flat external surfaces which seat against the opposing bone surfaces. Inasmuch as these bone surfaces are often concave, it is anticipated that the opposing plates may be convex in accordance with the average topology of the spinal anatomy. In addition, the plates are to mate with the bone surfaces in such a way as to not rotate relative thereto. (The plates rotate relative to one another, but not with respect to the bone surfaces to which they are each in contact with.) In order to prevent rotation of a plate relative to the bone, the upper and lower plates may each further include outwardly directed spikes which penetrate the bone surface and mechanically hold the plates in place. It is further anticipated that the plates could include a porous coating into which the bone of the vertebral body can grow, however, it is not a limitation which is required of embodiments of the invention. (Note that this limited fusion of the bone to the base plate does not extend across the intervertebral space.) While not preferred, it is possible, that between the base plates, on the exterior of the device, there may be included a circumferential wall which is resilient and which simply prevents vessels and tissues from entering within the interior of the device. This resilient wall may comprise a porous fabric or a semi-impermeable elastomeric material. Suitable tissue compatible materials meeting the simple mechanical requirements of flexibility and durability are prevalent in a number of medical fields including cardiovascular medicine, wherein such materials are utilized for venous and arterial wall repair, or for use with artificial valve replacements. Alternatively, suitable plastic materials are utilized in the surgical repair of gross damage to muscles and organs. Still further materials which could be utilized herein may be found in the field of orthopedic in conjunction with ligament and tendon repair. It is anticipated that future developments in this area will produce materials which are compatible for use with this invention, the breadth of which shall not be limited by the choice of such a material. Notwithstanding the foregoing, such an exterior shroud and/or the interior elastomeric materials which may be compatible with the present invention, they are not preferred for use with the present device. As introduced above, the internal structure of the present invention comprises a spring member, which provides a restoring force when compressed. More particularly, the force restoring member comprises at least one belleville washer. In the embodiments described herein, the belleville washer has a radially varying thickness. It is desirable that the restoring forces be directed outward against the opposing plates, and for the restoring force versus load profile to vary in a manner which approximates that of the normal healthy intervertebral cartilage. In addition, it is desirable that the restoring force providing subassembly not substantially interfere with the rotation of the opposing plates relative to one another, at least through a range of angles equivalent to that permitted by normal healthy intervertebral cartilage. More particularly, the restoring force providing subassembly comprises a belleville washer having a radially varying thickness. Belleville washers are washers which are generally bowed in the radial direction. Specifically, they have a radial convexity (i.e., the height of the washers is not linearly related to the radial distance, but may, for example, be parabolic in shape). The restoring force of a belleville washer is proportional to the elastic properties and the thickness of the material. In addition, the magnitude of the compressive load support and the restoring force provided by the belleville washer may be modified by providing slots in the washer. In the present invention, there are two separate embodiments each having two variations. The two variations described herein relate to whether the washers include spiral slots which initiate on the periphery of the washer and extend along arcs which are generally radially inwardly directed a distance toward the center of the bowed disc. The first embodiment (which can exist in two variations, i.e. slotted or unslotted) comprises a radially varying thickness which is grows thicker as the radius increases (the thickness is directly proportional to the radius). In the second embodiment (also existing in the two embodiments which can be either slotted or unslotted), the washers comprise a radially varying thickness which is grows thinner as the radius increases (the thickness is inversely proportional to the radius). In both of these embodiments, superior reproduction of the anatomical deflection to load characteristics is achieved. As a compressive load is applied to a belleville washer, the forces are directed into a hoop stress which tends to radially expand the washer. This hoop stress is counterbalanced by the material strength of the washer, and the strain of the material causes a deflection in the height of the washer. Stated equivalently, a belleville washer responds to a compressive load by deflecting compressively, but provides a restoring force which is proportional to the elastic modulus of the material in a hoop stressed condition. The purpose of the present invention is to create a non-linear load deflection profile by permitting a portion of the washer to deflect early in the loading, and a more rigid portion to deflect only under more severe loadings. By varying the thickness of the washer material smoothly across it's radial extent, this goal is achieved. It is preferred that either embodiment be of the variation in which the slots are provided inasmuch as the slots permit the washer to expands and restores itself far more elastically than a solid washer. In general, the belleville washer is one of the strongest configurations for a spring, and is highly suitable for use as a restoring force providing subassembly for use in an intervertebral spacer element which must endure considerable cyclical loading in an active human adult. Referring now to the specific structure of the device, the selected belleville washer is utilized in conjunction with a ball-shaped post on which it is free to rotate through a range of angles (thus permitting the plates to rotate relative to one another through a corresponding range of angles). More particularly, the invention comprises a pair of spaced apart base plates, the first of which is simply a disc shaped member having external and internal flat faces. This first plate further includes a circular retaining wall for housing therein a selected belleville washer and a retaining ring. The other of the plates is similarly shaped, having a flat exterior surface, but includes a short central post portion instead of the circular retaining wall. This central post rises out of the interior face at a nearly perpendicular angle. The top of this short post portion includes a ball-shaped knob. The knob includes a central threaded axial bore which receives a small set screw. Prior to the insertion of the set screw, the ball-shaped head of the post can deflect radially inward (so that the ball-shaped knob contracts). The insertion of the set screw eliminates the capacity for this deflection. As introduced above, radially modified thickness (and potentially spirally slotted) belleville washer is mounted to this ball-shaped knob in such a way that it may rotate freely through a range of angles equivalent to the fraction of normal human spine rotation (to mimic normal disc rotation). The belleville washer of this design is modified by including an enlarged inner circumferential portion (at the center of the washer) which accommodates the ball-shaped portion of the post. More particularly, the enlarged portion of the modified belleville washer includes a curvate volume having a substantially constant radius of curvature which is also substantially equivalent to the radius of the ball-shaped head of the post. The deflectability of the ball-shaped head of the post, prior to the insertion of the set screw, permits the head to be inserted into the interior volume at the center of the belleville washer. Subsequent introduction of the set screw into the axial bore of the post prevents the ball-shaped head from deflecting. Thereby, the washer can be secured to the ball-shaped head so that it can rotate thereon through a range of proper lordotic angles (in some embodiments, a tightening of the set screw locks the washer on the ball-shaped head at one of the lordotic angles). This assembly provides ample spring-like performance with respect to axial compressive loads, as well as long cycle life to mimic the axial biomechanical performance of the normal human intervertebral disc. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side perspective view of an interbody fusion device of the prior art. FIG. 2 is a front view of the anterior portion of the lumbo-sacral region of a human spine, into which a pair of interbody fusion devices of the type shown in FIG. 1 have been implanted. FIGS. 3 a and 3 b are side cross-section views of the upper and lower opposing plates of the present invention. FIG. 4 shows a cross-sectional view of a belleville washer with a thinner inner portion and a thicker outer portion. FIG. 5 shows another cross-sectional view of a belleville washer, in accordance with another preferred embodiment of the present invention. FIG. 6 shows a cross-sectional view of a belleville washer with a thicker inner portion and a thinner outer portion, in accordance with another preferred embodiment of the present invention. FIG. 7 shows a cross-sectional view of a belleville washer, in accordance with another preferred embodiment of the present invention. FIGS. 8 a , 8 b , and 8 c are top views of the opposing plates, and more particularly, FIG. 8 a is a top view of the plate having a post element which seats within the central opening of the belleville washer, FIG. 8 b is a top view of the plate having the circumferential skirt and a retaining ring, in which a belleville washer of the type of FIGS. 4-7 is disposed within the skirt, and FIG. 8 c is a top view of the plate having the circumferential skirt and a retaining ring, in which a belleville washer of the type of FIGS. 4-7 is disposed within the skirt. FIGS. 9 , 10 , 11 , and 12 are side cross-section views of various embodiments of the present invention which utilizes the corresponding belleville washers illustrated in FIGS. 4-7 mounted between the plates illustrated in FIGS. 3 a and 3 b. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT While the present invention will be described more fully hereinafter with reference to the accompanying drawings, in which particular embodiments and methods of implantation are shown, it is to be understood at the outset that persons skilled in the art may modify the invention herein described while achieving the functions and results of this invention. Accordingly, the descriptions which follow are to be understood as illustrative and exemplary of specific structures, aspects and features within the broad scope of the present invention and not as limiting of such broad scope, which scope shall be determined only by the claims appended hereto. Like numbers refer to similar features of like elements throughout. Referring now to FIGS. 3 a and 3 b , side cross-section views of the top and bottom plate members 100 , 200 of a first embodiment of the present invention is shown. As the device is designed to be positioned between the facing surfaces of adjacent vertebral bodies, the plates include substantially flat surface portions 102 , 202 which seat against the opposing bone surfaces. In addition, the plates are to mate with the bone surfaces in such a way as to not rotate relative thereto. It is, therefore, preferred that the plates should include a porous coating 104 , 204 into which the bone of the vertebral body can grow. (Note that this limited fusion of the bone to the base plate does not extend across the intervertebral space.) Referring now also to FIGS. 8 a and 8 b , plate 100 further includes a circumferential skirt 106 which serves as a retaining wall, into which the large end of a belleville washer (see FIGS. 4-7 ) may be seated. The diameter of the retaining wall 106 is preferably slightly wider than the diameter of the undeflected belleville washer such that the loading thereof can result in an unrestrained radial deflection of the washer. The inner surface of the retaining wall 106 includes an annular recess into which a retaining ring may be provided for holding the belleville washer in place (see the assembled FIGS. 9-12 ). Referring now also to FIG. 8 c , plate 200 further includes a central post 206 which rises out of the interior face 208 at a nearly perpendicular angle. The top of this short post member 206 includes a ball-shaped head 210 . The head 210 includes a series of slots 212 which render it compressible and expandable in correspondence with a radial pressure (or a radial component of a pressure applied thereto). There is a central threaded axial bore 214 which extends down the post 206 . This threaded bore 214 is designed to receive a small set screw 216 . Prior to the insertion of the set screw 216 , the ball-shaped head 210 can deflect radially inward (so that the ball-shaped head contracts) permitting the belleville washer to be flexibly mounted thereon. The insertion of the set screw 216 eliminates (or greatly reduces) the capacity for this deflection. Referring now to FIGS. 4-7 , side cross-section views of four separate embodiments of the belleville washers are provided. In general, these belleville washers 130 comprise a domed circular shape (a section of a sphere or three dimensional paraboloid would be an appropriately corresponding shape), having a central opening 132 and an outer edge 134 . As a compressive load is applied to a belleville washer, the forces are directed into a hoop stress which tends to radially expand the washer. This hoop stress is counterbalanced by the material strength of the washer, and the strain of the material causes a deflection in the height of the washer. Stated equivalently, a belleville washer responds to a compressive load by deflecting compressively, but provides a restoring force which is proportional to the elastic modulus of the material in a hoop stressed condition. In the present invention, the thickness (the distance from the concave surface to the convex surface) of the material which comprises the washer varies from the edge of the central opening 132 to the outer edge 134 of the element. More particularly with respect to the washer in FIG. 4 (and shown within the circumferential ring of plate 100 in FIG. 8 b ), the belleville washer 130 a has a greater thickness at the outer edge 134 a than at the edge of the central opening. As the restoring force of a belleville washer is proportional to the elastic properties of the material as well as the quantity of material being loaded, the reduction of the material at the edge of the central opening 132 a permits a load/deflection profile in which the load which deflects the inner portion of the washer is less than the outer portion. This permits the washer to compress to initially compress easily under a light loading, but to rapidly (faster than a straight linear loading profile) become stiff and resist deflection. This loading profile is more anatomically relevant with respect to mimicking the performance of the cartilage present in a healthy intervertebral space. More particularly with respect to the washer in FIG. 5 (and shown within the circumferential ring of plate 100 in FIG. 10 ), the belleville washer 130 b also has a greater thickness at the outer edge 134 b than at the edge of the central opening. However, the washer further includes a series of spiral slots 138 b extending from the outer edge 134 b toward the central opening 132 b . The slots 138 b extend from the outer diameter of the belleville washer, inward along arcs generally directed toward the central opening 132 b of the element. The slots 138 b do not extend fully to the center of the device. In preferred embodiments, the slots may extend anywhere from a quarter to three quarters of the overall radius of the washer, depending upon the requirements of the patient, and the anatomical requirements of the device. As the restoring force of a belleville washer is proportional to both the geometry of the material being loaded and its elastic properties, the varying thickness combined with the radial slots 138 b permits a load/deflection profile in which the load which deflects the inner portion of the washer is less than the outer portion. This permits the washer to compress to initially compress easily under a light loading, but to rapidly (faster than a straight linear loading profile) become stiff and resist deflection. This loading profile is more anatomically relevant with respect to mimicking the performance of the cartilage present in a healthy intervertebral space. More particularly with respect to the washer in FIG. 6 (and shown within the circumferential ring of plate 100 in FIG. 11 ), the belleville washer 130 c has a smaller thickness at the outer edge 134 c than it is at the inner edge 132 c . As the restoring force of a belleville washer is proportional to the elastic properties of the material as well as the quantity of material being loaded, the reduction of the material at the outer edge 134 c permits a load profile in which the load which deflects the outer portion of the washer is less than the inner portion. This permits the washer to compress to initially compress easily under a light loading (as a result of outer edge deflection), but to rapidly (faster than a straight linear loading profile) become stiff and resist deflection. This loading profile is more anatomically relevant with respect to mimicking the performance of the cartilage present in a healthy intervertebral space. More particularly with respect to the washer in FIG. 7 (and shown within the circumferential ring of plate 100 in FIG. 12 ), the belleville washer 130 d has a smaller thickness at the outer edge 134 d than at the edge of the central opening. However, the washer further includes a series of spiral slots 138 d extending from the outer edge 134 d toward the central opening. The slots 138 d extend from the outer diameter of the belleville washer, inward along arcs generally directed toward the central opening of the element. The slots 138 d do not extend fully to the center of the device. In preferred embodiments, the slots may extend anywhere from a quarter to three quarters of the overall radius of the washer, depending upon the requirements of the patient, and the anatomical requirements of the device. As the restoring force of a belleville washer is proportional to both the geometry of the material being loaded and its elastic properties, the varying thickness combined with the radial slots 138 d permits a load/deflection profile in which the load which deflects the inner portion of the washer is less than the outer portion. This permits the washer to compress to initially compress easily under a light loading, but to rapidly (faster than a straight linear loading profile) become stiff and resist deflection. This loading profile is more anatomically relevant with respect to mimicking the performance of the cartilage present in a healthy intervertebral space. In addition, the central openings of each of the belleville washer embodiments described hereinabove further includes a curvate volume for receiving therein the ball-shaped head 210 of the post 206 of the lower plate 200 described above. Referring now to FIGS. 9-12 , side cross-sectional views of the fully assembled embodiments of the intervertebral spacers which comprise the present invention are provided. Each structure includes the belleville washer (selected from the corresponding ones illustrated in FIGS. 4-7 ). Each further includes the following common features: two opposing plates 100 , 200 having their flat surfaces 102 , 202 , respectively, directed away from one another (to be seated against the adjacent bone); a retaining ring 110 is seated in the annular groove of the retaining wall 106 ; and a ball-shaped-headed central post 206 extending into the central opening 132 of the corresponding belleville washer 130 , rotatably secured in place by set screw 216 . The deflectability of the ball-shaped head of the post 206 , prior to the insertion of the set screw 216 , permits the head to be inserted into the interior volume at the center of the belleville washer 130 . Subsequent introduction of the set screw 216 into the axial bore of the post 206 prevents the ball-shaped head from deflecting. Thereby, the washer 130 can be secured to the ball-shaped head so that it can rotate thereon through a range of proper lordotic angles. While not in this preferred embodiment, it should be noted that in other embodiments, a tightening of the set screw can lock the washer 130 on the ball-shaped head at one of the lordotic angles. While there has been described and illustrated embodiments of an intervertebral spacer device, it will be apparent to those skilled in the art that variations and modifications are possible without deviating from the broad spirit and principle of the present invention. The present invention shall, therefore, be not be limited by the specific embodiments provided herein solely as representative examples of such invention.

1a

BACKGROUND OF THE INVENTION [0001] The invention is in field of controlled delivery of therapeutic agents and more specifically concerns the delivery of drugs by the oral route of administration. [0002] It is generally accepted that the oral route of administration is preferred over parenteral administration by patients and has the highest degree of patient compliance. The use of bioadhesive drug delivery systems (BDDS) offers important advantages for oral dosing. Bioadhesive systems can be engineered to have increased residence time in the intestinal tract, which translates into increased local concentrations of therapeutic agents at the residence sites. For purposes of local or topical drug delivery, the increased residence time of BDDS often reduces the frequency of dosing, resulting in improved patient compliance, or else reduces the amount of drug required for dosing, resulting in a reduction of drug-related side-effects. [0003] An additional benefit of BDDS is derived from the close apposition of the BDDS to the target mucosa. The intimate contact of dosage form with mucosa reduces the distance required for drug uptake or drug action. The drug is delivered to the target tissue in a controlled manner and not diluted or deactivated by the contents of the gut lumen. This feature is especially important when the drug is a sensitive protein or DNA-based drug that can be readily deactivated by the harsh conditions of the intestinal tract. Proteins can be denatured by acid gastric pH or else hydrolyzed by a variety of proteases secreted by the gastric mucosa and pancreas. [0004] However for drugs that are not susceptible to proteolysis, degradation or deactivation, such as small organic molecules (SOM), adhesion of drug-loaded BDDS to the stomach and upper GI offers many advantages over conventional DDS. The increased residence time of BDDS in stomach and upper intestinal segments may serve as a platform for delivery of SOM to lower intestinal segments. Drug that is not delivered topically to the site of BDDS residence can flow downstream and be absorbed by jejunal mucosa. Since the upper GI is the primary site for most oral drug absorption and systemic delivery, the benefits of controlled release of drug and bioadhesion result in maintenance of serum drug levels within the therapeutic “window” for longer periods of time than simple bolus dosing. [0005] BDDS are controlled delivery systems where the therapeutic agent is encapsulated either as: (1) a matrix-type device consisting of drug encapsulated in polymer with bioadhesive properties or else containing excipients that increase bioadhesive properties of the system or (2) a diffusion-controlled system comprising a core of drug surrounded by a rate-limiting membrane. The membrane may contain bioadhesive polymers or excipients to increase adhesion to target mucosa. [0006] The scientific and patent literature details a variety of drug delivery systems demonstrating increased gastric retention based not upon bioadhesive properties of the delivery system but relying more upon structural-, density- or size-related properties of the drug delivery system. Floating dosage forms with increased gastric residence time were first described by Sheth and Tossounian in U.S. Pat. No. 4,167,558 and consisted of drugs encapsulated in hydrocolloids such as cellulose ethers, notably hydroxypropylethylcellulose. Hydration of the “Hydrodynamically Balanced System” or HBS in the gastric milieu created a gelled hydration boundary layer responsible for the system's flotation characteristics. Encapsulated drug was released by diffusion into the gastric contents after swelling. Gerogianis et al. ( Drug Dev. Ind. Pharm., 19:1061-1081 (1993)) demonstrated that floatation properties were linked to increased molecular weight and viscosity of polymers and reduced hydration of the polymers owing to chemical substitutions on the polymer sidechains. Sangekar et al. ( Intl. J. Pharm., 35:187-91 (1987)) compared an HBS formulation to a non-floating formulation and demonstrated that gastric emptying of the dosage forms were related to food and not the floating-properties of the dosage forms. Commercially available HBS formulations include Madopar CR (Roche) for delivery of L-dopa and benserazide and Valrease (Roche) for delivery of diazepam. Both formulations provided for more consistent systemic levels of drug and resulted in reduced dosing in human volunteers (Fell et al., Pharm. Tech. 24:82-91 (2000)). [0007] Gas-generating dosage forms have been used to provide flotation properties. The gas generated is typically carbon dioxide derived from exposure of encapsulated, solid bicarbonate to gastric acidity, and is entrapped in a gel matrix. Yang and Fassihi (J. Pharm. Sci. 85: 170-73 (1996)) described a three-layer, gas-generating tablet that demonstrated buoyancy for up to 16 hrs. in simulated gastric fluid (SGF) in vitro. Agyilirah et al. (Int. J. Pharm. 75:241-7 (1991) described a coated tablet formulation whose coating detached and swelled to more than six-times the original size upon exposure to SGP. [0008] Fell et al., ibid., describe a floating alginate bead system produced by freeze-drying. Alginate beads were produced by ionic gelatin in a calcium chloride bath, frozen and lyophilized. The resulting beads were porous and floated compared to beads dried in an oven. When tested in human volunteers, the solid beads resided in the stomach for 1 hr. while the hollow beads emptied after three hours. The prior art in the field for floating or hollow dosage forms is extensive. However, the degree of bioadhesiveness for these dosage forms is a function of size, density, and/or structure. Therefore the size of and materials for the particles are limited. [0009] It is therefore an object of the present invention to provide improved bioadhesive formulations for oral administration. [0010] It is another object of the invention to provide improved macrosphere formulations that can be encapsulated in capsules, wherein the macrospheres can have different release properties or contain different bioactive compounds. SUMMARY OF THE INVENTION [0011] Bioadhesive macrosphere delivery systems (“BDDS”) have been developed having prolonged gastric retention time due to bioadhesion rather than physical density or size. In general, the macrospheres have diameters that are greater than 200 microns, more preferably greater than 500 microns. The bioadhesive macrospheres are released in the stomach where they reside in close proximity to the gastric mucosa and do not float in the gastric contents. The mechanism of increased gastric retention is due to increased adhesion of the delivery system to gastric mucosa in the stomach and upper small intestine, where they reside for an extended period of time, as demonstrated by the examples, and are capable of delivering drugs locally or topically in the gastric compartment. As a result of the increased residence of BDDS in the upper GI, drug not absorbed at the site of residence can be directed to lower GI segments over long periods of time. The directed “overflow” of drug from a resident BDDS can lead to increased systemic absorption of drug in the preferred site of systemic absorption, namely the upper GI tract (upper to mid-jejunum). [0012] The BDDS may be engineered either as a capsule with drug delivery controlled by a diffusion-limited membrane or degradable shell, or as a solid matrix system with drug delivery controlled by a combination of diffusion and polymer degradation kinetics. One embodiment comprises a capsule or microcapsule ranging in size from 0.1 to 2.5 mm in diameter consisting of a solid core of drug, hydrophilic polymer binder and excipients coated with a rate-limiting membrane and a bioadhesive membrane. In one preferred embodiment, the core consists of drug in concentrations of 40-95% w/w. The cores may be manufactured using any of a number of techniques including but not limited to ionic gelation, hot-melt, melt-granulation, extrusion-spheronization, wet granulation, fluid-bed agglomeration etc. Alternatively, the cores may consist of commercially available “non-pareils”, e.g. SugarSphere, USP, to which the drug and polymer coating may be applied using different coating processes. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 is a flow chart of the production of macrosphere drug delivery devices, beginning with wet mixing, extrusion, spheronization, drying, and coating. [0014] FIG. 2 is a graph of enhanced GI residence time of macrospheres versus release time (hours). Four preparations were compared: A, the control macrospheres; B, macrospheres with a coating of fumaric acid pre-polymer (“FAPP”), with molecular weight less than 500 Da and Fe 3 O 4 ; C, macrospheres with a coating of fumaric acid-sebacic acid copolymer (“FA:SA”) 20:80, with a molecular weight less than 20,000 Da, and FAPP; D, macrospheres with a coating of FA:SA, FAPP and CaO. [0015] FIG. 3 is a graph of acyclovir concentration in serum (μg/ml) versus time (hours) after dosing in dogs. Formulation #1 (designated by ⋄) contained 5% of the total acyclovir loading incorporated in the bioadhesive coating, while Formulation #2 (designated by ▴) contained acyclovir only in the core. [0016] FIG. 4 is a bar graph comparing area under the curve values (μg/ml*hr) for Formulations #1 (left bar) and #2 (right bar). These values were calculated from the data in FIG. 3 . [0017] FIG. 5 is a bar graph comparing the residence time for the microspheres in Formulations #1 (left column) and #2 (right bar) in the upper GI of the dogs. [0018] FIG. 6 is a graph of release of acyclovir (ACV) and salicylate as a function of percent total acyclovir loading, over time (in hours), from macrospheres wherein the salicylate is encapsulated in an outer Eudragit® RL 100 coating and the acyclovir is encapsulated in the core. The outer drug loading is used to achieve rapid release (three hours) as compared to more long term release of the core drug (24 hours). DETAILED DESCRIPTION OF THE INVENTION [0019] The BDDS described herein consists of macrospheres, which include at least a therapeutic, diagnostic or prophylactic agent to be delivered, bioadhesive elements (which may be polymers, metal oxides, or ligands for specific mucosal components), and release controlling materials, which may effect release by degradation, diffusion, pH, or a combination thereof [0020] The macrospheres are typically in the range of from 0.1 to 3 mm in diameter, preferably greater than 0.2 mm, most preferably greater than 0.5 mm. They typically contain one or more agents to be delivered and one or more rate controlling materials, for example, rate controlling membranes. In some embodiments there are multiple therapeutic agents released at different times. In other embodiments, therapeutic agent is released from the rate controlling membrane as well as from the core of the macrosphere, where the therapeutic agent in the membrane may be the same or different from the agent in the core. macrospheres can be administered as a powder, encapsulated within a gelatin or enteric coating, or compressed into a tablet. macrospheres of the same or different carrier composition or active agent can be mixed together in a single formulation. [0021] The macrospheres can contain between 10 and 70% of therapeutic, diagnostic or prophylactic agent (referred to hereafter as “active”) by weight of macrosphere, or between 30 and 90% by weight of the core of a coated macrosphere, where each coating makes up between 1-10% , preferably 5-6%, by weight of the macrosphere, up to a total of about 30% by weight of the macrosphere. The coating can include active, in ratios of between 5 and 50% by weight of the coating, preferably between 20 and 40% by weight of the coating, while still retaining rate control. [0022] Polymers Useful in Forming Bioadhesive Particles [0023] Suitable polymers that can be used to form bioadhesive particles include soluble and insoluble, biodegradable and nonbiodegradable polymers. These can be hydrogels or thermoplastics, homopolymers, copolymers or blends, natural or synthetic. The preferred polymers are synthetic polymers, with controlled synthesis and degradation characteristics. Most preferred polymers are copolymers of fumaric acid and sebacic acid, which have unusually good bioadhesive properties when administered to the gastrointestinal tract. Other preferred polymers suitable for use in these systems include degradable polymers: polyesters such as poly-lactic acid (PLA), poly(lactide-co-glycolide) or PLGA, polycaprylactone (PCL); polyanhydrides such as poly(fumaric-co-sebacic) in molar ratios of 20:80 to 90:10, poly(carboxyphenoxypropane-co-sebacic acid (PCPP:SA); polyorthoesters; polyamides; and polyamides. Other suitable polymers include hydrogel based polymers such as agarose, alginate, chitosan etc. and non-degradable polymers such as polystyrene, polyvinylphenol, polymethylmethacrylates (Eudragits®). [0024] Rapidly bioerodible polymers such as poly[lactide-co-glycolide], polyanhydrides, and polyorthoesters, whose carboxylic groups are exposed on the external surface as their smooth surface erodes, are excellent candidates for bioadhesive drug delivery systems. In addition, polymers containing labile bonds, such as polyanhydrides and polyesters, are well known for their hydrolytic reactivity. Their hydrolytic degradation rates can generally be altered by simple changes in the polymer backbone. [0025] Representative natural polymers include proteins, such as zein, modified zein, casein, gelatin, gluten, serum albumin, or collagen, and polysaccharides, such as cellulose, dextrans, polyhyaluronic acid, polymers of acrylic and methacrylic esters and alginic acid. Synthetically modified natural polymers include alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers, cellulose esters, and nitrocelluloses. Representative synthetic polymers include polyphosphazines, poly(vinyl alcohols), polyamides, polycarbonates, polyalkylenes, polyacrylamides, polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates, polyvinyl ethers, polyvinyl esters, polyvinyl halides, polyvinylpyrrolidone, polyglycolides, polysiloxanes, polyurethanes and copolymers thereof. Representative bioerodible polymers include polylactides, polyglycolides and copolymers thereof, poly(ethylene terephthalate), poly(butic acid), poly(valeric acid), poly(lactide-co-caprolactone), poly[lactide-co-glycolide], polyanhydrides, polyorthoesters, blends and copolymers thereof. [0026] These polymers can be obtained from sources such as Sigma Chemical Co., St. Louis, Mo., Polysciences, Warrenton, Pa., Aldrich, Milwaukee, Wis., Fluka, Ronkonkoma, N.Y., and BioRad, Richmond, Calif. or else synthesized from monomers obtained from these suppliers using standard techniques. [0027] Bioadhesive Elements [0028] Polymers can be selected for or chemically modified to increase bioadhesion. For example, the polymers can be modified by increasing the number of carboxylic groups accessible during biodegradation, or on the polymer surface. The polymers can also be modified by binding amino groups to the polymer. The polymers can also be modified using any of a number of different coupling chemistries that covalently attach ligand molecules with bioadhesive properties to the surface-exposed molecules of the polymeric particles. [0029] One useful protocol involves the “activation” of hydroxyl groups on polymer chains with the agent, carbonyldiimidazole (CDI) in aprotic solvents such as DMSO, acetone, or THF. CDI forms an imidazolyl carbamate complex with the hydroxyl group which may be displaced by binding the free amino group of a ligand such as a protein. The reaction is an N-nucleophilic substitution and results in a stable N-alkylcarbamate linkage of the ligand to the polymer. The “coupling” of the ligand to the “activated” polymer matrix is maximal in the pH range of 9-10 and normally requires at least 24 hrs. The resulting ligand-polymer complex is stable and resists hydrolysis for extended periods of time. [0030] Another coupling method involves the use of 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide (EDAC) or “water-soluble CDI” in conjunction with N-hydroxylsulfosuccimide (sulfo NHS) to couple the exposed carboxylic groups of polymers to the free amino groups of ligands in a totally aqueous environment at the physiological pH of 7.0. Briefly, EDAC and sulfo-NHS form an activated ester with the carboxylic acid groups of the polymer which react with the amine end of a ligand to form a peptide bond. The resulting peptide bond is resistant to hydrolysis. The use of sulfo-NHS in the reaction increases the efficiency of the EDAC coupling by a factor of ten-fold and provides for exceptionally gentle conditions that ensure the viability of the ligand-polymer complex. By using either of these protocols it is possible to “activate” almost all polymers containing either hydroxyl or carboxyl groups in a suitable solvent system that will not dissolve the polymer matrix. [0031] A useful coupling procedure for attaching ligands with free hydroxyl and carboxyl groups to polymers involves the use of the cross-linking agent, divinylsulfone. This method would be useful for attaching sugars or other hydroxylic compounds with bioadhesive properties to hydroxylic matrices. Briefly, the activation involves the reaction of divinylsulfone to the hydroxyl groups of the polymer, forming the vinylsulfonyl ethyl ether of the polymer. The vinyl groups will couple to alcohols, phenols and even amines. Activation and coupling take place at pH 11. The linkage is stable in the pH range from 1-8 and is suitable for transit through the intestine. [0032] Any suitable coupling method known to those skilled in the art for the coupling of ligands and polymers with double bonds, including the use of UV crosslinking, may be used for attachment of bioadhesive ligands to the polymeric particles described herein. Any polymer that can be modified through the attachment of lectins can be used as a bioadhesive polymer for purposes of drug delivery or imaging. [0033] Lectins that can be covalently attached to particles to render them target specific to the mucin and mucosal cell layer could be used as bioadhesives. Useful lectin ligands include lectins isolated from: Abrus precatroius, Agaricus bisporus, Anguilla anguilla, Arachis hypogaea, Pandeiraea simplicifolia, Bauhinia purpurea, Caragan arobrescens, Cicer arietinum, Codium fragile, Datura stramonium, Dolichos biflorus, Erythrina corallodendron, Erythrina cristagalli, Euonymus europaeus, Glycine max, Helix aspersa, Helix pomatia, Lathyrus odoratus, Lens culinaris, Limulus polyphemus, Lysopersicon esculentum, Maclurapomifera, Momordica charantia, Mycoplasma gallisepticum, Naja mocambique, as well as the lectins Concanavalin A, Succinyl-Concanavalin A, Triticum vulgaris, Ulex europaeus I, II and III, Sambucus nigra, Maackia amurensis, Limaxfluvus, Homarus americanus, Cancer antennarius, and Lotus tetragonolobus. [0034] The attachment of any positively charged ligand, such as polyethyleneimine or polylysine, to any particle may improve bioadhesion due to the electrostatic attraction of the cationic groups coating the beads to the net negative charge of the mucus. The mucopolysaccharides and mucoproteins of the mucin layer, especially the sialic acid residues, are responsible for the negative charge coating. Any ligand with a high binding affinity for mucin could also be covalently linked to most particles with the appropriate chemistry, such as CDI, and be expected to influence the binding of particles to the gut. For example, polyclonal antibodies raised against components of mucin or else intact mucin, when covalently coupled to particles, would provide for increased bioadhesion. Similarly, antibodies directed against specific cell surface receptors exposed on the lumenal surface of the intestinal tract would increase the residence time of beads, when coupled to particles using the appropriate chemistry. The ligand affinity need not be based only on electrostatic charge, but other useful physical parameters such as solubility in mucin or else specific affinity to carbohydrate groups. [0035] The covalent attachment of any of the natural components of mucin in either pure or partially purified form to the particles would decrease the surface tension of the bead-gut interface and increase the penetration of the bead into the mucin layer. The list of useful ligands would include but not be limited to the following: sialic acid, neuraminic acid, n-acetyl-neurarminic acid, n-glycolylneuraminic acid, 4-acetyl-n-acetylneuraminic acid, diacetyl-n-acetylneuraminic acid, glucuronic acid, iduronic acid, galactose, glucose, mannose, fucose, any of the partially purified fractions prepared by chemical treatment of naturally occurring mucin, e.g., mucoproteins, mucopolysaccharides and mucopolysaccharide-protein complexes, and antibodies immunoreactive against proteins or sugar structure on the mucosal surface. [0036] The attachment of polyamino acids containing extra pendant carboxylic acid side groups, e.g., polyaspartic acid and polyglutamic acid, should also provide a useful means of increasing bioadhesiveness. Using polyamino acids in the 15,000 to 50,000 kDa molecular weight range would yield chains of 120 to 425 amino acid residues attached to the surface of the particles. The polyamino chains would increase bioadhesion by means of chain entanglement in mucin strands as well as by increased carboxylic charge. [0037] The bioadhesive properties of a polymer are enhanced by incorporating a metal compound into the polymer to enhance the ability of the polymer to adhere to a tissue surface such as a mucosal membrane. Metal compounds which enhance the bioadhesive properties of a polymer preferably are water-insoluble metal compounds, such as water-insoluble metal oxides and hydroxides, including oxides of calcium, iron, copper and zinc. The metal compounds can be incorporated within a wide range of hydrophilic and hydrophobic polymers including proteins, polysaccharides and synthetic biocompatible polymers. In one embodiment, metal oxides can be incorporated within polymers used to form or coat drug delivery devices, such as microspheres, which contain a drug or diagnostic agent. The metal compounds can be provided in the form of a fine dispersion of particles on the surface of a polymer that coats or forms the devices, which enhances the ability of the devices to bind to mucosal membranes. As defined herein, a water-insoluble metal compound is defined as a metal compound with little or no solubility in water, for example, less than about 0.9 mg/ml. [0038] The water-insoluble metal compounds, such as metal oxides, can be incorporated by one of the following mechanisms: (a) physical mixtures which result in entrapment of the metal compound; (b) ionic interaction between metal compound and polymer; (c) surface modification of the polymers which would result in exposed metal compound on the surface; and (d) coating techniques such as fluidized bead, pan coating or any similar methods known to those skilled in the art, which produce a metal compound enriched layer on the surface of the device. [0039] Preferred properties defining the metal compound include: (a) substantial insolubility in aqueous environments, such as acidic or basic aqueous environments (such as those present in the gastric lumen); and (b) ionizable surface charge at the pH of the aqueous environment. The water-insoluble metal compounds can be derived from metals including calcium, iron, copper, zinc, cadmium, zirconium and titanium. For example, a variety of water-insoluble metal oxide powders may be used to improve the bioadhesive properties of polymers such as ferric oxide, zinc oxide, titanium oxide, copper oxide, barium hydroxide, stannic oxide, aluminum oxide, nickel oxide, zirconium oxide and cadmium oxide. The incorporation of water-insoluble metal compounds such as ferric oxide, copper oxide and zinc oxide can tremendously improve adhesion of the polymer to tissue surfaces such as mucosal membranes, for example in the gastrointestinal system. [0040] Polymers with enhanced bioadhesive properties can also be obtained by incorporating into the polymer anhydride monomers or oligomers. The polymers may be used to form drug delivery systems which have improved ability to adhere to tissue surfaces, such as mucosal membranes. The anhydride oligomers are formed from organic diacid monomers, preferably the diacids normally found in the Krebs glycolysis cycle. Anhydride oligomers which enhance the bioadhesive properties of a polymer have a molecular weight of about 5000 or less, typically between about 100 and 5000 daltons, or include 20 or fewer diacid units linked by anhydride linkages and terminating in an anhydride linkage with a carboxylic acid monomer. [0041] The oligomer excipients can be blended or incorporated into a wide range of hydrophilic and hydrophobic polymers including proteins, polysaccharides and synthetic biocompatible polymers. In one embodiment, oligomers can be incorporated within polymers used to form or coat drug delivery systems, such as microspheres, which contain a drug or diagnostic agent. In another embodiment, oligomers with suitable molecular weight may be used alone to encapsulate therapeutic or diagnostic agents. In yet another embodiment, anhydride oligomers may be combined with metal oxide particles to improve bioadhesion even more than with the organic additives alone. Organic dyes because of their electronic charge and hydrophobicity/hydrophilicity can either increase or decrease the bioadhesive properties of polymers when incorporated into the polymers. [0042] Formation of Particles [0043] a. Solvent Evaporation. In this method the polymer is dissolved in a volatile organic solvent, such as methylene chloride. The drug (either soluble or dispersed as fine particles) is added to the solution, and the mixture is suspended in an aqueous solution that contains a surface active agent such as poly(vinyl alcohol). The resulting emulsion is stirred until most of the organic solvent evaporated, leaving solid particles. Several different polymer concentrations can be used, including concentrations ranging from 0.05 to 0.20 g/ml. The solution is loaded with a drug and suspended in 200 ml of vigorously stirred distilled water containing 1% (w/v) poly(vinyl alcohol) (Sigma). After 4 hours of stirring, the organic solvent evaporates from the polymer, and the resulting particles are washed with water and dried overnight in a lyophilizer. Particles with different sizes (1-1000 microns) and morphologies can be obtained by this method. This method is useful for relatively stable polymers like polyesters and polystyrene. [0044] However, labile polymers, such as polyanhydrides, may degrade during the fabrication process due to the presence of water. For these polymers, the following two methods, which are performed in completely anhydrous organic solvents, are more useful. [0045] b. Hot Melt Microencapsulation. In this method, the polymer is first melted and then mixed with the solid particles of dye or drug that have been sieved to less than 50 microns. The mixture is suspended in a non-miscible solvent (like silicon oil), and, with continuous stirring, heated to 5° C. above the melting point of the polymer. Once the emulsion is stabilized, it is cooled until the polymer particles solidify. The resulting particles are washed by decantation with petroleum ether to give a free-flowing powder. Particles with sizes between one to 1000 microns are obtained with this method. The external surfaces of spheres prepared with this technique are usually smooth and dense. This procedure is used to prepare particles made of polyesters and polyanhydrides. However, this method is limited to polymers with molecular weights between 1000-50,000. [0046] c. Solvent Removal. This technique is primarily designed for polyanhydrides. In this method, the drug is dispersed or dissolved in a solution of the selected polymer in a volatile organic solvent like methylene chloride. This mixture is suspended by stirring in an organic oil (such as silicon oil) to form an emulsion. Unlike solvent evaporation, this method can be used to make particles from polymers with high melting points and different molecular weights. Particles that range between 1-300 microns can be obtained by this procedure. The external morphology of spheres produced with this technique is highly dependent on the type of polymer used. [0047] d. Hydrogel Particles. Particles made of gel-type polymers, such as alginate, are produced through traditional ionic gelation techniques. The polymers are first dissolved in an aqueous solution, mixed with barium sulfate or some bioactive agent, and then extruded through a microdroplet forming device, which in some instances employs a flow of nitrogen gas to break off the droplet. A slowly stirred (approximately 100-170 RPM) ionic hardening bath is positioned below the extruding device to catch the forming microdroplets. The particles are left to incubate in the bath for twenty to thirty minutes in order to allow sufficient time for gelation to occur. Particle size is controlled by using various size extruders or varying either the nitrogen gas or polymer solution flow rates. [0048] Chitosan particles can be prepared by dissolving the polymer in acidic solution and crosslinking it with tripolyphosphate. Carboxymethyl cellulose (CMC) particles were prepared by dissolving the polymer in acid solution and precipitating the particle with lead ions. Alginate/polyethylene imide (PEI) were prepared in order to reduce the amount of carboxylic groups on the alginate microcapsule. The advantage of these systems is the ability to further modify their surface properties by the use of different chemistries. In the case of negatively charged polymers (e.g., alginate, CMC), positively charged ligands (e.g., polylysine, polyethyleneimine) of different molecular weights can be ionically attached. [0049] e. Extrusion-Spheronization. Core particles may be prepared by the process of granulation-extrusion-spheronization. In this process, micronized drug is mixed with microcrystalline cellulose, binders, diluents and water and extruded as a wet mass through a screen. The result is rods with diameters equal to the opening of the extrusion screen, typically in the size range of 0.1 to 5 mm. The rods are then cut into segments of approximately equal length with a rotating blade and transferred to a spheronizer. The spheronizer consists of a rapidly rotating, textured plate which propels rod segments against the stationary walls of the apparatus. Over the course of 1-10 minutes of spheronization, the rods are slowly transformed into spherical shapes by abrasion. The resulting spheroid cores are then discharged from the machine and dried at 40-50° C. for 2448 hours using tray-driers or fluidized bed dryers. The cores may then be coated with rate-releasing, enteric or bioadhesive polymers using either pan-coating or fluidized-bed coating devices. [0050] Excipients—Hydrophilic Binders; Diluents [0051] The macrospheres can include other materials, such as hydrophilic binders. Examples include any of the pharmaceutically accepted hydrogels, e.g., alginate, chitosan, methylmethacrylates (e.g. Eudragit®), celluloses (especially microcrystalline cellulose, hydroxypropylmethylcellulose, ethylcellulose etc.), agarose, Providone™. Examples of other excipients include diluents such as lactose, microcrystalline cellulose, kaolin, starch or magnesium stearate, density-controlling agents such as barium sulfate or oils, and rate-controlling agents such as magnesium stearate, oils, ion-exchange resins. [0052] Macrospheres can be incorporated into standard pharmaceutical dosage forms such as gelatin capsules and tablets. Gelatin capsules, available in sizes 000, 00, 0, 1, 2, 3, 4, and 5, from manufactures such as Capsugel®, may be filled with macrospheres and administered orally. Similarly, macrospheres may be dry blended or wet-granulated with diluents such as microcrystalline cellulose, lactose, cabosil and binders such as hydroxypropylmethylcellulose, hydroxypropylcellulose, carboxymethylcellulose and directly compressed to form tablets. The dimensions of the tablets are limited only by the engineering of dies available for tabletting machines. Dies to form tablets in round, oblong, convex, flat, and bullet designs in sizes ranging from 1 to 20 mm are available. The resulting tablets may weigh from 1 to 5,000 mg and carry macrospheres at loadings of 1 to 80% w/w. [0053] The resulting tablets may be coated with sugars, enteric polymers or gelatin to alter dissolution of the tablet and release of the macrospheres into the GI tract. Alternately, tablet diluents may include gas generating elements such as tartaric acid, citric acid and sodium bicarbonate, as examples. Exposure of the tablet to water or gastric fluids facilitates reaction of the weak acid with bicarbonate, resulting in evolution of carbon dioxide. Evolution of gas disrupts the mechanical integrity of the tablet, facilitating release of incorporated macrospheres. Premature dissolution of the tablet in the mouth may be prevented by coating with hydrophilic polymers, such as hydroxypropylmethylcellulose or gelatin, resulting in dissolution in the stomach. [0054] Rate Controlling Elements [0055] Rate control can be achieved by the use of a membrane or diffusion-limiting coating(s), by controlling the rate of degradation of the polymer, and/or the porosity of the macrosphere. Further rate control can be achieved through the use of a capsule such as a gelatin capsule, an enteric coating, and/or tablet size and compression techniques. [0056] The membrane or diffusion-limiting coating can be formed from a variety of different materials including pharmaceutically-accepted polymeric coating materials such as methylmethacrylates (e.g. Eudragit®, Rohm and Haas and Kollicoat®, BASF), zein, cellulose, acetate, cellulose phthalate, hydroxylpropylmethylcellulose, etc. The coatings may be applied using a variety of techniques including fluidized-bed coating, pan-coating and dip-coating. In the preferred embodiment, the coating is applied as a fluidized-bed coating. [0057] Therapeutic, Prophylactic and Diagnostic Agents [0058] Therapeutic agents to be encapsulated include antivirals such as acyclovir and protease inhibitors alone or in combination with nucleosides for treatment of HIV or Hepatitis B or C, anti-parasites (helminths, protozoans), anti-cancer agents (referred to herein as “chemotherapeutic”, including cytotoxic drugs such as cisplatin and carboplatin, BCNU, 5FU, methotrexate, adriamycin, camptothecin, and taxol), antibodies and bioactive fragments thereof (including humanized, single chain, and chimeric antibodies), antigen and vaccine formulations, peptide drugs, anti-inflammatories, oligonucleotide drugs (including antisense, aptamers, ribozymes, external guide sequences for ribonuclease P, and triplex forming agents), antibiotics, antiinflammatories including non-steroidal antiinflammatories (“NSAIDS”) such as methyl salicylate, antiulcerative agents such as bismuth subsalicylate, digestive supplements and cofactors, and vitamins, especially those that are not normally absorbed in the colon. Examples of other useful drugs include ulcer treatments such as Carafate® from Marion Pharmaceuticals, neurotransmitters such as L-DOPA, antihypertensives or saluretics such as Metolazone from Searle Pharmaceuticals, carbonic anhydrase inhibitors such as Acetazolamide from Lederle Pharmaceuticals, insulin like drugs such as glyburide, a blood glucose lowering drug of the sulfonylurea class, synthetic hormones such as Android F from Brown Pharmaceuticals and Testred (methyltestosterone) from ICN Pharmaceuticals, and antiparasitics such as mebendzole (Vermox®, Jannsen Pharmaceutical). Other drugs for application to the vaginal lining or other mucosal membrane lined orifices such as the rectum include spermacides, yeast or trichomonas treatments and anti-hemorrhoidal treatments. [0059] Antigens can be encapsulated in one or more types of bioadhesive polymer to provide a vaccine. The vaccines can be produced to have different retention times in the gastrointestinal tract. The different retention times, among other factors, can stimulate production of more than one type (IgG, IgM, IgA, IgE, etc.) of antibody. [0060] Multiple drug formulations can be prepared either (1) by encapsulating different drugs in coatings/cores or (2) by simply mixing separate batches of particles each containing a single drug to make a new batch containing multiple drugs, as demonstrated by Example 2, in which a model drug, sodium salicylate, is prepared in an outer Eudragit® RL100 coating and a second drug, acyclovir, is prepared in the core. The sodium salicylate is quickly released within 3 hours while the acyclovir has sustained release over the course of 24 hrs. [0061] In a preferred method for imaging, a radio-opaque material such as barium is coated with polymer. Other radioactive materials or magnetic materials could be used in place of, or in addition to, the radio-opaque materials. Examples of other materials include gases or gas-emitting compounds, which are radioopaque. [0062] Barium sulfate suspension is the universal contrast medium used for examination of the upper gastrointestinal tract, as described by D. Sutton, Ed., A Textbook of Radiology and Imaging, Vol. 2, Churchill Livingstone, London (1980), even though it has undesirable properties, such as unpalatability and a tendency to precipitate out of solution. Several properties are critical: (a) Particle size: the rate of sedimentation is proportional to particle size (i.e., the finer the particle, the more stable the suspension); (b) Non-ionic medium: charges on the barium sulfate particles influence the rate of aggregation of the particles, and aggregation is enhanced in the presence of the gastric contents; and (c) Solution pH: suspension stability is best at pH 5.3, however, as the suspension passes through the stomach, it is inevitably acidified and tends to precipitate. The encapsulation of barium sulfate in particles of appropriate size provides a good separation of individual contrast elements and may, if the polymer displays bioadhesive properties, help in coating, preferentially, the gastric mucosa in the presence of excessive gastric fluid. With bioadhesiveness targeted to more distal segments of the gastrointestinal tract, it may also provide a kind of wall imaging not easily obtained otherwise. The double contrast technique, which utilizes both gas and barium sulfate to enhance the imaging process, especially requires a proper coating of the mucosal surface. To achieve a double contrast, air or carbon dioxide must be introduced into the patient's gastrointestinal tract. This is typically achieved via a nasogastric tube to provoke a controlled degree of gastric distension. Studies indicate that comparable results may be obtained by the release of individual gas bubbles in a large number of individual adhesive particles and that this imaging process may apply to intestinal segments beyond the stomach. [0063] Administration of Bioadhesive Particles to Patients [0064] The macrosphere particles are administered to the mucosal membranes, typically via the nose, mouth, rectum, or vagina. In the preferred embodiment, the macrospheres are administered orally. Pharmaceutically acceptable carriers for oral or topical administration are known and can be determined based on compatibility with the polymeric material. Other carriers include bulking agents, such as Metamucil®. [0065] Macrospheres are typically administered in an effective amount based on the agent to be delivered. This amount will be determined based on the known properties and pharmacokinetics of the drugs to be delivered, although this may be adjusted as appropriate in view of the increased residence time, which may enhance the percent uptake of the drug into the gastrointestinal tract. [0066] An in vivo method for evaluating bioadhesion uses encapsulation of a radio-opaque material, such as barium sulfate, or both a radio-opaque material and a gas-evolving agent, such as sodium carbonate, within a bioadhesive polymer. After oral administration of the radio-opaque material, its distribution in the gastric and intestinal areas is examined using image analysis. [0067] The present invention will be further understood by reference to the following non-limiting examples. EXAMPLE 1 Preparation of Macrospheres for Release of Acyclovir [0068] Macrospheres with acyclovir in the cores in an amount of 80% and 90% w/w were made using the wet-granulation/extrusion/spheronization process. The overall yield of the process was 90%, and 90% of the spheronized cores were within the size range of 1.4-2.36 mm. [0069] FIG. 1 is a graph of the granulating and spheronization process used to make the macrospheres. Five unit operations are involved in this process. They are (1) wet granulation (making the dough), (2) extrusion of the granulation or “dough” into cylinders, (3) spheronization of the cylinders into spheres, (4) drying, and (5) film coating. EXAMPLE 2 Macrospheres with Modified Release [0070] Release kinetics were obtained from macrospheres with the following compositions: (1) naked drug cores; (2) EUDRAGIT® RL100-coated (diffusion controlling layer) cores and (3) FASA/FAPP/CaO (bioadhesive)-RL100-drug cores. By incorporating drug into the outer bioadhesive coating, nearly first order release kinetics were obtained. [0071] The ability to tailor and optimize drug release is achieved by encapsulating drug in either the bioadhesive (composition #3) or rate-limiting (compositions #2) coating or combinations of the two. It is also possible to spray pure drug onto the surface of the outer coating to achieve a quick burst of available drug. The latter can be demonstrated by spraying RL 100 as a 5% coating over 40% drug-loaded cores. The drug in the coating is sodium salicylate (“Drug 1”); the drug in the core is acyclovir (ACV) (”Drug 2”). [0072] This example demonstrates production of a rate-limiting membrane over the 40% ACV cores. EUDRAGITS® are traditionally used to control release properties of drug-loaded spheres. Spraying RL 100 in the correct concentration gives the desired drug release properties. [0073] Materials/Controls: A 200.4 g lot of beads, 40% w/w Acyclovir (1.4-2.36 mm) was used as the cores for the coatings. TABLE 1 COMPOSITION OF EUDRAGIT ® RL 100 COATING Liquid Solid Components gm w/w Gm w/w Eudragit ® RL 100 6 5.00% 6 49.59% DBS 0.6 0.50% 0.6 4.96% Talc 4.9 4.08% 4.9 40.50% Mg Stearate 0.6 0.50% 0.6 4.96% DCM 24 19.98% IPA 84 69.94% Total 120.1 100.00% 12.1 100.00% [0074] The beads were fluidized at 200 fps with an inlet air temperature of 86° F. using the Wurster setup. The 10″ Wurster tube was used, and set 1″ from the top of the spray nozzle. The coatings were sprayed at an atomization pressure of 10 psi. The formulation exhibited a weight gain of 12.3 g (6.1%). The beads were dried in the fluidized bed for 5 min. The coatings appeared thin and uniform. [0075] Macrospheres containing 30% acyclovir cores were also manufactured. The macrospheres were separated by sieving and the weight of cores (in grams) in a size range was measured. The weight percentage of cores was calculated with respect to the total mass of cores that were sieved. The size ranges (mm), along with their corresponding weight percentages are: greater than 2.36 mm comprised 1% w/w; 1.7-2.36 mm comprised 70% w/w; and less than 1.4 mm comprised 9% w/w. The total recovery of the sieved macrospheres comprised 80% w/w. EXAMPLE 3 Production of Macrospheres with Rate-limiting Membrane and Bioadhesive Coating [0076] Macrospheres containing 30% acyclovir cores were prepared as described in Example 1, with a rate-limiting membrane as described in Example 2, and further coated with a bioadhesive membrane including EUDRAGIT®, calcium oxide, FAPP (anhydride oligomer), and polymer (polyfumaric acid:sebacic acid). The bioadhesive coating is preferably approximately 50 microns in thickness, although coatings can be between 5 and 20 microns, and 5-20% w/w. The bioadhesive coating was applied by fluidized bed coating. Alternatively the coating may be applied by pan coating. TABLE 2 COMPOSITION OF COATING SOLUTIONS 1 st Coat 2 nd Coat Total Solids Total Solids Component gm % w/w gm % w/w Eudragit ® RS 100 5 50 NA NA P(FA:SA) NA NA 3 15 FAPP NA NA 4 24 CaO NA NA 7 41 Magnesium Stearate 1 10 NA NA Talc 3.5 35 NA NA Dibutyl Sebacate 0.5 5 1 5 Isopropanol 70 32 Dichloromethane 20 50 [0077] The function of the materials is as follows: Eudragit® RS 100—Rate-Limiting Polymer; P(FA:SA)—Bioadhesive Polymer, FAPP—Organic Bioadhesive Excipient; CaO—Inorganic Bioadhesive Excipient; Magnesium Stearate—Lubricant; Talc—Glidant; Dibutyl Sebacate—Plasticizer; Isopropanol—Solvent; Dichloromethane—Solvent. [0078] The first coat provided controlled release. The second coat provided a bioadhesive surface. EXAMPLE 4 Retention in Gastrointestinal Tract of Macrospheres [0079] Macrospheres prepared as in Example 3 were administered to dogs and the dogs were x-rayed. The beads contained barium sulfate so that they could be imaged. The cores of the beads were prepared by extrusion/spheronization, with a size range between 1.4 and 2.36 mm, and contained 50% w/w barium sulfate. Control macrospheres were formed with the same composition, but without the bioadhesive coatings. Four preparations were compared: A, the control macrospheres; B, macrospheres with a coating of fumaric acid pre-polymer (“FAPP”), with molecular weight less than 500 Da and Fe 3 O 4 ; C, macrospheres with a coating of fumaric acid-sebacic acid copolymer (“FA:SA”) 20:80, with a molecular weight less than 20,000 Da, and FAPP; D, macrospheres with a coating of FA:SA, FAPP and CaO. TABLE 3 COMPOSITION OF 30% ACYCLOVIR* (W/W) MACROSPHERE CORES % w/w Component Function Solids Total Microcrystalline Cellulose Wet-Massing Excipient 50 35.7 Barium Sulfate Density/Radiopaque Agent 17.5 12.5 Hydroxypropyl Cellulose Binder 2 1.4 Acyclovir* Active 30 21.4 SDS Extrusion Excipient/ 0.5 0.4 lubricant Water 28.6 *Acyclovir was not included in the dog imaging studies, but was added for the release kinetic studies described in Example 5. The weight difference in the dog imaging study was made up by addition of barium sulfate. [0080] 3.0 grams of macrospheres dry compressed (2000 psi for 10 seconds in a Stokes DS-3 manual tabletting die) with inert tabletting excipients (1.5 g macrospheres/tablets, 1 gram of lactose, 0.5 g tartaric acid, and 0.5 g sodium bicarbonate) into tablets were administered orally to dogs fasted for 18 hours. Water was given ad libitum. The animals were x-rayed every thirty minutes. [0081] FIG. 2 is a graph comparing the residence times of the bioadhesive macrospheres with the residence times of the control macrospheres. After 30 minutes, the control and bioadhesive macrospheres were just entering the small intestine. After 1.5 hours, the control macrospheres were distributed throughout the small intestine, but the bioadhesive macrospheres were still in the upper portion of the small intestine. After 2.5 hours, the control macrospheres were in the lower portion of the small intestine, while the bioadhesive macrospheres were still in the upper portion of the small intestine. Animals were fed 3.5 hours after dosing. After 6.5 hours, the control macrospheres were passing through the lower portion of the lower intestine, while the bioadhesive macrospheres were just beginning to descend through the small intestine. After 8.5 hours, the bioadhesive macrospheres were distributed throughout the small intestine. After 24 hours, no control macrospheres were detected by x-ray, while the bioadhesive macrospheres were beginning passage through the lower intestine. EXAMPLE 5 In Vitro Release from Macrospheres [0082] The release properties of two macrosphere formulations in simulated gastric fluid at 37° C. are shown in FIG. 3 . Formulation #1 had 5% of the total drug loading incorporated in the bioadhesive coating, while Formulation #2 had drug only in the core. The formulations released 40-50% of their load in 6-8 hrs and 100% of the loading in 24 hrs. EXAMPLE 6 In Vivo Release from Macrospheres Tested in Dogs [0083] The formulations in Example 5 were filled into #000 gel caps and orally administered to beagles that had been fasted for 18 hrs. The dose was equivalent to 1.0 gm of acyclovir/dog (˜80-90 mg/kg). Blood samples were obtained by venipuncture at 1.5, 3, 4.5, 6, 7.5, 9, 10.5, 12, 13.5, 15, 16.5, 18 and 24 hours post-dosing and analyzed for acyclvoir concentration by HPLC. The animals were X-rayed at each time point to track the transit of macrospheres. The maximum serum concentration (Cmax) for Formulation 1 was 20.5±3.6 μg/ml (mean±SEM, n=14) and the Cmax for Formulation 2 was 26.7±7.1 μg/ml (mean±SEM, n=12). The maximum serum concentration was reached between 3-4.5 hrs post-dosing (Tmax) for both formulations. Therapeutic serum concentrations were maintained for a minimum of 15 hrs post-dosing. [0084] The “area under the serum concentration versus time curves” (AUC) displayed in FIG. 4 were calculated using Prism software. Formulation 1 had an AUC of 107±11 μg/ml*hr (mean±SEM, n=14) and Formulation 2 had a similar AUC of 111±13 μg/ml*hr (mean±SEM, n=12). [0085] The residence time of macrospheres in the “upper GI” of dogs (stomach and small intestine) was determined by analysis of x-rays. The results are shown in FIG. 5 . Formulation.1 had an upper GI residence time of 14.2±1.5 hr (mean±SEM, n=14) and Formulation 2 had a similar residence time of 16.2±1.8 hrs (mean±SEM, n=12). EXAMPLE 7 Production of Multi-Drug Macrospheres [0086] Fluidized bed spraying of 5% RL 100-coated 40% Acyclovir (ACV) loaded cores with 25% sodium salicylate w/w in a 10% RL 100-coating was then used to produce multi-drug macrospheres. [0087] The starting material was the product of Example 2 (5% w/w RL 100 coated 40% ACV cores and overcoat with 10% RL 100 coating containing 25% w/w sodium salicylate). Overcoating with a 10% w/w coating of RL100 containing 25% w/w salicylate was used to produce a biphasic drug system. Sodium salicylate should be quickly delivered followed by acyclovir release. A 176.0 g lot of beads, 40% w/w Acyclovir (1.4-2.36 mm) was used as the cores for the coatings. TABLE 4 COMPOSITION OF EUDRAGIT ® RL 100 COATING Liquid Solid Component gm w/w gm w/w Eudragit ® RL 100 5.9 3.25% 5.9 16.91% DBS 0 0.00% 0 0.00% Talc 20 11.03% 20 57.31% Mg Stearate 0 0.00% 0 0.00% DCM 146.5 80.76% 0.00% IPA 0 0.00% 0.00% Sodium Salicylate 9 4.96% 9 25.79% Total 181.4 100.00% 34.9 100.00% [0088] The beads were fluidized at 200 fps with an inlet air temperature of 89° F. using the Wurster setup. The 10″ Wurster tube was used; and set 1″ from the top of the spray nozzle. The coatings were sprayed at an atomization pressure of 10 psi. The formulation exhibited a weight gain of 17.4 g (9.9%). The beads were dried in the fluidized bed for 5 min. The coatings appeared thin and uniform. [0089] Multiple attempts were made to spray this formulation, all of which failed. The beads coalesced after a few minutes of spraying and could not be fluidized. It was determined that sodium salicylate was partially soluble in IPA and acted as a plasticizer. To counteract this phenomenon, DBS and IPA were omitted and the amount of talc was increased by 4 fold. The resulting improved formulation sprayed perfectly. EXAMPLE 8 Release Kinetics from Multi-Drug Macrospheres [0090] The release kinetics of the two drugs from the macrospheres of Example 6 were then determined. FIG. 6 is a graph of release of acyclovir (ACV) and salicylate as a function of percent total acyclovir loading, over time (in hours), from macrospheres wherein the salicylate is encapsulated in an outer Eudragit® RL 100 coating and the acyclovir is encapsulated in the core. The outer drug loading is used to achieve rapid release (three hours) as compared to more long term release of the core drug (24 hours). EXAMPLE 9 Scale Up Production of Acyclovir Cores [0091] This example demonstrates the production of 40% drug-loaded sphere cores of MCC/HPC/BaSO 4 and lactose with a diameter size distribution between 1.4 mm and 2.36 mm, and establishes that a procedure which can be increased in scale. [0092] Materials/Controls: Fresh extrusion mix was prepared. The dry solids listed below in Table 5 were combined in the Hobart mixer and mixed for 5 min at speed setting #1. Water was poured in and the mixture was stirred for 10 minutes on the low gear. The resulting mixture was free flowing and grainy. The granulation was stored in a sealed plastic bag at 4° C. overnight (16 hrs) and extruded in the morning. TABLE 5 COMPOSITION OF 40% ACYLCLOVIR CORES w/w Weight w/w Total Material Manufacturer Catalog # Lot # (g) Solids Mix Microcrystalline Spectrum CE112 PX0066 351.9 35.0% 25.6% Cellulose (MCC) Lactose Spectrum LA103 PO0171 0 0.0% 0.0% Barium Sulfate Fluka 11845 409062/1 23600 231.3 23.0% 16.8% (BaSO 4 ) Hydroxypropyl Hercules KLUCEL EF 8622 14.3 1.4% 1.0% cellulose (HPC) Acyclovir Interchem 1.41E+09 Certificate 24965 400.2 39.8% 29.1% SLS Spectrum S133 PP0623 8.3 0.8% 0.6% Water 370.3 26.9% Solids total 1006.0 73.1% Total 1376.3 100.0% [0093] The bulk mixture was extruded on a Caleva Model 25 extruder with a 2 mm screen at 7 rpm. The bulk mixture appeared to be nearly optimal. The bulk mixture was spheronized in 2 batches on a Caleva Model 250 spheronizer using the coarse plate (pitch size 4.5 mm) at 1000 rpm for 10 minutes. The spheronized extrudate was separated based on size. The fines content (<0.5 mm) was 1.8 μg (0.2%). The spheronized extrudate was tray-dried in a conventional oven at 50° C. overnight. The dry spheres were separated based on size (mm), weight (gm), and yield (%w/w): (a) <0.5, 1.8, 0.18%; (b) 0.5-1.4, 150.5, 14.96%; (c) 1.4-2.36, 769.6, 76.51%; and (d) >2.36, 27.2, 2.70%. The total recovery from raw materials was 949.1 g (94.4%).

1a

This application claims priority based on U.S. Provisional Patent Application Serial No. 60/171,305, filed Dec. 21, 1999, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to osmotic delivery devices for delivering beneficial agents, and more particularly, to osmotic delivery devices having an osmotic engine and a valve to prevent expulsion of the beneficial agents. 2. Description of the Related Art Controlled delivery of beneficial agents, such as drugs, in the medical and veterinary fields has been accomplished by a variety of methods. One method for controlled prolonged delivery of beneficial agents involves the use of osmotic delivery systems. These systems can be implanted within a body of a human or animal to release beneficial agents in a controlled manner over a preselected time or administration period. In general, osmotic delivery systems operate by imbibing liquid from the outside environment and releasing corresponding amounts of the beneficial agent. A known osmotic delivery system, commonly referred to as an “osmotic pump,” generally includes some type of a capsule or enclosure having a semipermeable portion which selectively passes water into an interior of the capsule containing a water-attracting osmotic agent. In one known osmotic delivery system the walls of the capsule are substantially impermeable to items within and outside the capsule. A membrane plug is inserted into one end of the capsule and acts as the semipermeable portion allowing water to pass into the interior of the capsule. The difference in osmolarity between the water-attracting osmotic agent and the environment surrounding the capsule causes water to pass through the membrane plug into the capsule which in turn causes the beneficial agent within the capsule to be delivered through a delivery orifice. The water-attracting osmotic agent may be the beneficial agent delivered to the patient; however, in most cases a separate osmotic agent is used specifically for its ability to draw water into the capsule. When a separate osmotic agent is used, the osmotic agent may be separated from the beneficial agent within the capsule by a movable dividing member or piston. The structure of the capsule is such that the capsule does not expand when the osmotic agent takes in water and expands. As the osmotic agent expands, it causes the piston to move and the beneficial agent to be discharged through the delivery orifice at the same rate as the liquid, which is typically water, enters the osmotic agent by osmosis. Osmotic delivery systems may be designed to deliver a beneficial agent at a controlled constant rate, a varying rate, or in a pulsatile manner. In the known osmotic delivery systems, an osmotic tablet is generally used as the osmotic agent and is placed inside the capsule adjacent the piston. A membrane plug is placed in an opening in the capsule through which the tablet and piston were inserted. Known membrane plugs are typically cylindrical members which seal the interior of the capsule from the exterior environment, permitting only certain liquid molecules from the environment of use to permeate through the membrane plug into the interior of the capsule. The rate that the liquid permeates through the membrane plug controls the rate at which the osmotic agent expands and drives the beneficial agent from the delivery system through the delivery orifice. The rate of delivery of the beneficial agent from the osmotic delivery system may be controlled by varying the size of the beneficial agent delivery orifice, the osmotic material, a size and shape of the membrane plug, or the permeability coefficient of the membrane plug. It is desirable to seal the beneficial agent delivery orifice of the delivery system to prevent incursion of materials into the delivery system before sufficient osmotic pressure exists to insure a flow of the beneficial agent through the orifice. Protecting the beneficial agent from the external environment is particularly important when the beneficial agent is a protein formulation or other agent which breaks down when in contact with certain environmental compositions. In order to prevent contamination or early release of the beneficial agent, some delivery systems are provided with a plug in the orifice which is discharged upon movement of the piston by the fluid pressure within the system. Typically, such osmotic delivery systems use mechanical plugs, bio-eroding, or dissolving plugs. With mechanical plugs, such plugs are chemically stable materials discharged from the delivery system on movement of a piston contained within the system. Premature release of the beneficial agent may occur when the delivery system is jarred, thereby loosening the mechanical plug from the system. Further, mechanical plugs expelled from the delivery device may not be acceptable with the patient when left in the patient's body at the implant site. Bio-eroding or dissolving plugs also present drug delivery problems since such plugs allow the drug delivery orifice to open regardless of whether or not the osmotic agent can exert sufficient hydraulic pressure to insure flow of the beneficial agent. Because of the above-identified problems associated with current osmotic delivery systems, it is desirable to prevent contamination of the beneficial agent and to prevent beneficial agent leakage by providing a delivery orifice valve which is not expelled into the patient's body. SUMMARY OF THE INVENTION The present invention relates to osmotic delivery systems having an osmotic engine and a valve to prevent contamination and/or expulsion of the beneficial agents. In accordance with one aspect of the present invention, a delivery system for controlled delivery of a beneficial agent includes an implantable capsule having a delivery orifice, a separating member dividing the capsule into a beneficial agent reservoir and a driving reservoir, an osmotic engine in the driving reservoir, and a valve member that can move from a closed position to an open position. In the closed position, the valve member prevents the expulsion of beneficial agent from the beneficial agent reservoir through the delivery orifice. The implantable capsule can include an attachable cap having a vent. In operation, the osmotic engine imbibes fluid thereby causing the engine to swell. This swelling causes the osmotic engine to exert a pressure on the separating member whereby such pressure moves the separating member, the beneficial agent reservoir, and the valve member a distance such that the valve member moves to an open position, allowing passage of beneficial agent through the delivery orifice at a desired delivery rate. In accordance with another aspect of the present invention, a method of preventing contamination from entering the osmotic delivery device before activation includes the steps of providing a delivery device capsule enclosing a first chamber which contains a beneficial agent and a valve member. The first chamber has an opening communicating with the external environment. Before activation of the delivery device, the valve member occludes the opening. This occlusion prevents the beneficial agent from leaving the device, as well as prevents the incursion of contaminants into the device. In accordance with an additional aspect of the present invention, a method of controlling an initial release of a beneficial agent from an osmotic delivery device includes the steps of providing a delivery device capsule which encloses a first chamber containing the beneficial agent, a valve member, and a second chamber containing an osmotic agent. The first chamber has a beneficial agent delivery orifice communicating with the external environment. The valve member is initially in a closed position and blocks beneficial agent from passing through the beneficial agent delivery orifice. Upon implantation, the osmotic agent imbibes surrounding fluid to form an osmotic solute which expands and exerts a pressure on the first chamber. The osmotic imbibition of surrounding fluid builds pressure within the osmotic engine until sufficient force is exerted to move the first chamber and valve member, the valve member moving from the closed position to an open position. With the valve in the opened position, beneficial agent contained in the first chamber can pass through the beneficial agent delivery orifice to the external environment. The present invention provides the advantage of a more controllable beneficial agent delivery rate by preventing expulsion of beneficial agent from the drug reservoir by using a valve to occlude the drug delivery orifice. The valve does not allow beneficial agent to pass through the delivery orifice until sufficient hydraulic pressure exists to displace the beneficial agent from the drug reservoir. Moreover, the present invention retains the valve within delivery device, whereby removing the implant from the patient after delivering the medication allows retrieval of both the valve and the implant device. BRIEF DESCRIPTION OF THE FIGURES The invention will now be described in greater detail with reference to the preferred embodiments illustrated in the accompanying drawings, in which like elements bear like reference numerals, and wherein: FIG. 1 is a side cross-sectional view of an osmotic delivery device according to the present invention; FIG. 2 is a side cross-sectional view of the osmotic delivery device of FIG. 1 delivering a beneficial agent through an orifice; FIG. 3 is a side cross-sectional view of an osmotic delivery system having an alternative embodiment of a cap with the cap in closed position; and FIG. 4 is a side cross-sectional view of an osmotic delivery system having an alternative embodiment of a cap with the cap in opened position. DETAILED DESCRIPTION The present invention relates to an osmotic delivery system for controlled delivery of a beneficial agent. FIGS. 1-4 illustrate two examples of osmotic delivery devices 10 according to the present invention. The osmotic drug delivery device 10 , as illustrated in FIG. 1, includes a movable valve 28 , a first chamber 22 containing a beneficial agent, a separating member 20 , and a second chamber 24 containing an osmotic engine or agent, all of which are enclosed within an elongated substantially cylindrical enclosure or capsule 12 . The capsule 12 has a first end 14 and an open end 16 . The first end 14 of the capsule 12 has one or more orifices or ports 18 for delivering a beneficial agent contained within a first chamber 22 of the osmotic delivery device 10 to an external environment. In most configurations, one delivery port 18 will suffice. However, two or more delivery ports 18 may be present without departing from the present invention. The valve 28 occludes the delivery orifice 18 when the valve is in a closed position, preventing the beneficial agent in the first chamber 22 from leaving the delivery device 10 as well as preventing the incursion of foreign materials into the device. The dimensions of the valve 28 in terms of both diameter and length are selected such that the valve will not exit the delivery device 10 through the delivery orifice 18 . The separating member 20 also separates the first chamber 22 containing the beneficial agent from the second chamber 24 containing the osmotic agent. The separating member 20 and valve 28 are substantially cylindrical members which are configured to fit within the capsule 12 and are slidably movable along a longitudinal direction within the capsule. The separating member and valve 20 , 28 preferably are formed of a resilient material which is impermeable to the compositions within the capsule 12 , and at least a portion of the separating member 20 and the valve 28 forms a seal with the inner surface of said capsule 12 . In addition, the movable separating member and valve 20 , 28 may be flexible members such as pistons, partitions, pads, flat sheets, spheroids, or rigid metal alloys, and may be made of any number of inert materials. Furthermore, the osmotic device 10 may function without the piston 20 , having simply an interface between the osmotic agent and the beneficial agent. A semipermeable membrane 30 couples with the capsule 12 at the open end 16 and encloses the second chamber 24 containing the osmotic agent. The osmotic agent may be, for example, a nonvolatile water soluble osmagent, an osmopolymer which swells on contact with water, or a mixture of the two. The elongated capsule 12 is formed of a material which is sufficiently rigid to withstand expansion of the osmotic agent contained within a second chamber 24 of the delivery device 10 without changing size or shape. The elongated capsule 12 is preferably substantially impermeable to fluids in the environment as well as to ingredients contained within the osmotic delivery device 10 such that the migration of such materials into or out of the device through the impermeable material of the capsule is so low as to have substantially no adverse impact on the function of the osmotic delivery device. As shown in FIGS. 1 and 2, the osmotic delivery device 10 of one embodiment of the present invention includes a semipermeable membrane 30 , which is coupled with the open end 16 of the capsule 12 . In operation, after placing the osmotic agent within the second chamber 24 of the capsule, the semipermeable membrane 30 allows liquid to pass from an environment of use into the capsule 12 to cause the osmotic agent to swell. However, the material forming the semipermeable membrane 30 is largely impermeable to the materials within the capsule 12 and to other ingredients within the environment of use. The swelling osmotic agent exerts a pressure on the separating member or piston 20 and forces said separating member to move a distance D in a direction of the arrow A. The separating member 20 applies a force to the beneficial agent in the first chamber 22 , the beneficial agent transfers the force to the valve 28 . Accordingly, this force causes the valve 28 to move a distance C from the close position to an open position. A clearance 34 between the valve 28 and the first end 14 decreases by the distance C. In the open position, the valve 28 allows the beneficial agent to pass through the delivery orifice 18 to the external environment of use. The osmotic agent in conjunction with the separating member 20 drive the beneficial agent from the first chamber 22 and insures a flow of beneficial agent out of the delivery orifice 18 . The valve 28 is retained within the delivery device 10 at the closed first end 14 of the capsule 12 and, as described above, the valve 28 has dimensions such that it will not leave the delivery device 10 through the delivery orifice 18 . In a preferred embodiment, the capsule 12 has a vent 32 at the first end 14 , allowing fluid to escape from the clearance 34 between the valve 28 and the capsule 12 when the valve 28 moves toward the first end 14 . Depending on the application, the clearance 34 between the valve 28 and the capsule 12 may be filled with a bio-compatible liquid or gas. The configuration of the osmotic delivery system and the material of the semipermeable membrane 30 control the delivery rate of a beneficial agent from the osmotic delivery system. In assembling the osmotic delivery device 10 according to the embodiment of the present invention shown in FIGS. 1 and 2, the capsule 12 is prepared by forming at least one vent 32 at the first end 14 of the capsule. The vent 32 may be formed by mechanical drilling, laser drilling, molding, or any other known method. The delivery port 18 is an orifice formed by conventional techniques which are known in the art. Included among these methods are mechanical drilling, laser drilling, and molding. The dimensions of the delivery port 18 in terms of both diameter and length will vary with the type of beneficial agent, the rate at which the beneficial agent is to be delivered, and the environment into which it is to be delivered. The considerations involved in determining the optimum dimensions of the delivery port 18 for any particular capsule 12 or beneficial agent and the selection of the appropriate dimensions will be readily apparent to those skilled in the art. Once the capsule 12 of FIGS. 1 and 2 has been prepared with the vent 32 and at least one delivery port 18 , having a number, shape, and size to achieve a desired delivery rate of the beneficial agent, the valve 28 is inserted into the capsule 12 through the open end 16 . According to one embodiment of the present invention, the beneficial agent contained in the first chamber 22 of the capsule 12 is a flowable composition such as a liquid, suspension, or slurry, and is typically poured into the first chamber 22 of the capsule after the valve 28 has been inserted. The separating member 20 is inserted into the capsule 12 through the open end 16 and is positioned adjacent the beneficial agent. Once the osmotic agent pellet(s) or tablet(s) have been formed, they are placed inside the pre-formed capsule in the second chamber 24 adjacent the separating member 20 . Then the semipermeable membrane 30 , according to one embodiment of the present invention, is placed into or over the open end 16 of the capsule 12 to close off and seal the open end of the osmotic delivery system. An alternative embodiment of the invention illustrated in FIGS. 3-4 includes a cap 36 having a hollow interior and a substantially constant thickness cylindrical side wall 42 and an end wall 44 . The cap 36 forms the first end 50 of the capsule 12 . In a preferred embodiment, the cap 36 affixes to the body of the capsule 12 by a snap fitting mechanism 38 , such as a barbed stake. The cap 36 preferably has a vent 48 in the end wall 44 which after assembly allows the valve 28 to move in a direction towards the end wall 14 . In a different embodiment, the cap 36 can be pivotally rotated about a hinge in a direction of the arrow B, as depicted in FIG. 4 . The first chamber 22 of the osmotic delivery device 40 has at least one opening 46 which communicates with the environment of use. As shown in FIG. 3, the opening 46 is formed in the body of the capsule 12 and is positioned adjacent the contacting surfaces of the cap. Alternatively, the opening 46 can be formed in the cap 36 and positioned adjacent the contacting surfaces of the body of the capsule 12 . The semipermeable membrane 30 couples with the capsule 12 at the opened second end 52 . In assembling the osmotic delivery device 10 according to the embodiment of the present invention shown in FIGS. 3 and 4, the cap 36 is prepared by forming at least one vent 48 at the end wall 44 . The vent 48 may be formed by mechanical drilling, laser drilling, molding, or any other known method. The capsule 12 is prepared having an opened first end 50 and an opened second end 52 . The delivery port 46 is an orifice positioned at the edge of the cap 36 adjacent the capsule 12 , or the delivery port 46 is positioned at the edge of the capsule 12 adjacent the cap 36 . The delivery port 18 is formed by conventional techniques which are known in the art. Included among these methods are laser drilling, mechanical drilling, grooving the edge of the capsule or cap, and molding. The separating member 20 is inserted into the capsule 12 through the first or second end 50 , 52 . Once the osmotic agent pellet(s) or tablet(s) have been formed, they are placed inside the capsule 12 in the second chamber 24 , adjacent the separating member 20 . The semipermeable membrane 30 is placed into or over the second end 52 to close off and seal that end. Beneficial agent is added into the first chamber 22 of the capsule 12 through the first end 50 , and the valve 28 is inserted adjacent the beneficial agent in a closed position. As discussed, the valve 28 in a closed position prevents the beneficial agent from leaving the delivery device 10 and prevents incursion of foreign materials into the device. Then the cap 36 is placed at the first end 50 of the capsule to close off and seal that open end of the osmotic delivery system 10 . The cap 36 may be secured to the capsule 12 by press fitting, snap fitting, threading, adhesive, welding, staking, or the like. In general, materials suitable for use in the movable separating member 20 and the valve 28 are elastomeric materials including non-reactive polymers, as well as elastomers in general, such as polyurethanes and polyamides, chlorinated rubbers, styrene-butadiene rubbers, and chloroprene rubbers. The polymers include acrylonitrile polymers such as acrylonitrile-butadiene-styrene terpolymer, and the like; halogenated polymers such as polytetraflouroethylene, polychlorotrifluoroethylene, copolymer tetrafluoroethylene and hexafluoropropylene; polyimide; polysulfone; polycarbonate; polyethylene; polypropylene; polyvinylchloride-acrylic copolymer; polycarbonate-acrylonitrile-butadiene-styrene; polystyrene; and the like. Semipermeable compositions suitable for the semipermeable membrane 30 are well known in the art, examples of which are disclosed in U.S. Pat. No. 4,874,388, the entire disclosure of which is incorporated herein by reference. Such possible semipermeable materials from which the membrane 30 can be made include, but are not limited to, for example, Hytrel polyester elastomers (DuPont), cellulose esters, cellulose ethers, and cellulose ester-ethers, water flux enhanced ethylene-vinyl acetate copolymers, semipermeable membranes made by blending a rigid polymer with water-soluble low molecular weight compounds, and other semipermeable materials well known in the art. The above cellulosic polymers have a degree of substitution, D.S., on the anhydroglucose unit, from greater than 0 up to 3 inclusive. By “degree of substitution” or “D.S.” is meant the average number of hydroxyl groups originally present on the anhydroglucose unit comprising the cellulose polymer that are replaced by a substituting group. Representative materials include, but are not limited to, one selected from the group consisting of cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate, cellulose triacetate, mono-, di-, and tricellulose alkanylates, mono-, di-, and tricellulose aroylates, and the like. Exemplary cellulosic polymers include cellulose acetate having a D.S. up to 1 and an acetyl content up to 21%; cellulose acetate having a D.S. of 1 to 2 and an acetyl content of 21% to 35%; cellulose acetate having a D.S. of 2 to 3 and an acetyl content of 35% to 44.8%, and the like. More specific cellulosic polymers include cellulose propionate having a D.S. of 1.8 and a propionyl content of 39.2% to 45% and a hydroxyl content of 2.8% to 5.4%; cellulose acetate butyrate having a D.S. of 1.8 and an acetyl content of 13% to 15% and a butyryl content of 34% to 39%; cellulose acetate butyrate having an acetyl content of 2% to 29%, a butyryl content of 17% to 53%, and a hydroxyl content of 0.5% to 4.7%; cellulose acetate butyrate having a D.S. of 1.8, an acetyl content of 4% average weight percent, and a butyryl content of 51%; cellulose triacylates having a D.S. of 2.9 to 3 such as cellulose trivalerate, cellulose trilaurate, cellulose tripalmitate, cellulose trisuccinate, and cellulose trioctanoate; cellulose diacylates having a D.S. of 2.2 to 2.6 such as cellulose disuccinate, cellulose dipalmitate, cellulose dioctanoate, cellulose dipentate; coesters of cellulose such as cellulose acetate butyrate and cellulose, cellulose acetate propionate, and the like. Other materials for the membrane 30 are polyurethane, polyetherblockamide (PEBAX, commercially available from ELF ATOCHEM, Inc.), and injection-moldable thermoplastic polymers with some hydrophilicity such as ethylene vinyl alcohol (EVA). In general, the membrane 30 is made from semipermeable materials having a water uptake ranging from 1% to 80% but preferably less than 50%. The composition of the semipermeable membrane 30 is permeable to the passage of external liquids such as water and biological liquids, and it is substantially impermeable to the passage of beneficial agents, osmopolymers, osmagents, and the like. Materials which may be used for the capsule 12 and the cap 36 must be sufficiently strong to ensure that the capsule will not leak, crack, break, or distort under stresses to which it is subjected during implantation or under stresses due to the pressures generated during operation. The capsule 12 may be formed of chemically inert and biocompatible, natural or synthetic materials which are known in the art. The capsule material is preferably a nonbioerodible material which remains in the patient after use, such as titanium or a titanium alloy, and is largely impermeable to materials within and outside the capsule. However, the material of the capsule 12 may alternatively be a bioerodible material which bioerodes in the environment after dispensing of the beneficial agent. Generally, preferred materials for the capsule 12 are those acceptable for animal and human implants. In general, typical materials of construction suitable for the capsule 12 according to the present invention include non-reactive polymers or biocompatible metals or alloys. Metallic materials useful for the capsule 12 include stainless steel, titanium, platinum, tantalum, gold, and their alloys, as well as gold-plated ferrous alloys, platinum-plated ferrous alloys, cobalt-chromium alloys and titanium nitride coated stainless steel. The capsule 12 may be formed from any of the wall-forming materials disclosed above by the use of a mold, with the materials applied either over the mold or inside the mold, depending on the mold configuration. Any of the wide variety of techniques known in the pharmaceutical industry may be used to form the capsule 12 . The osmotic agent is a liquid-attracting agent used to drive the flow of the beneficial agent. The osmotic agent may be an osmagent, an osmopolymer, or a mixture of the two. Species which fall within the category of osmagent, i.e., the non-volatile species which are soluble in water and create the osmotic gradient driving the osmotic inflow of water, vary widely. Examples are well known in the art and include magnesium sulfate, magnesium chloride, potassium sulfate, sodium chloride, sodium sulfate, lithium sulfate, sodium phosphate, potassium phosphate, d-mannitol, sorbitol, inositol, urea, magnesium succinate, tartaric acid, raffinose, and various monosaccharides, oligosaccharides and polysaccharides such as sucrose, glucose, lactose, fructose, and dextran, as well as mixtures of any of these various species. Species which fall within the category of osmopolymer are hydrophilic polymers that swell upon contact with water, and these vary widely as well. Osmopolymers may be of plant or animal origin, or synthetic, and examples of osmopolymers are well known in the art. Examples include: poly(hydroxyalkyl methacrylates) with molecular weight of 30,000 to 5,000,000, poly(vinylpyrrolidone) with molecular weight of 10,000 to 360,000, anionic and cationic hydrogels, polyelectrolyte complexes, poly(vinyl alcohol) having low acetate residual, optionally cross linked with glyoxal, formaldehyde, or glutaraldehyde and having a degree of polymerization of 200 to 30,000, a mixture of methyl cellulose, cross linked agar and carboxymethylcellulose, a mixture of hydroxypropl methycellulose and sodium carboxymethylcellulose, polymers of N-vinyllactams, polyoxyethylene-polyoxypropylene gels, polyoxybutylene-polyethylene block copolymer gels, carob gum, polyacrylic gels, polyester gels, polyuria gels, polyether gels, polyamide gels, polypeptide gels, polyamino acid gels, polycellulosic gels, carbopol acidic carboxy polymers having molecular weights of 250,000 to 4,000,000, Cyanamer polyacrylamides, cross linked indene-maleic anhydride polymers, Good-Rite polyacrylic acids having molecular weights of 80,000 to 200,000, Polyox Polyethylene oxide polymers having molecular weights of 100,000 to 5,000,000, starch graft copolymers, and Aqua-Keeps acrylate polymer polysaccharides. The osmotic agent may be a solid osmotic tablet or a fluid osmotic agent. The osmotic tablet may be formed in many different conceivable shapes, textures, densities, and consistencies and still be within the confines of the present invention. The osmotic agent may be manufactured by a variety of techniques, many of which are known in the art. In one such technique, the osmotically active agent is prepared as solid or semi-solid formulation and pressed into pellets or tablets whose dimensions correspond to slightly less than the internal dimensions of the respective chambers which they will occupy in the capsule interior. Depending on the nature of the materials used, the agent and other solid ingredients which may be included may be processed prior to the formation of the pellets by such procedures as ballmilling, calendaring, stirring, or rollmilling to achieve a fine particle size and hence fairly uniform mixtures of each. The present invention applies to the administration of beneficial agents in general, which include any physiologically or pharmacologically active substance. Drug agents which may be delivered by the present invention include drugs which act on the peripheral nerves, adrenergic receptors, cholinergic receptors, the skeletal muscles, the cardiovascular system, smooth muscles, the blood circulatory system, synoptic sites, neuroeffector junctional sites, endocrine and hormone systems, the immunological system, the reproductive system, the skeletal system, autacoid systems, the alimentary and excretory systems, the histamine system and the central nervous system. Suitable agents may be selected from, for example, proteins, enzymes, hormones, polynucleotides, nucleoproteins, polysaccharides, glycoproteins, lipoproteins, polypeptides, steroids, analgesics, local anesthetics, antibiotic agents, anti-inflanunatory corticosteroids, ocular drugs and synthetic analogs of these species. Examples of drugs which may be delivered by devices according to this invention include, but are not limited to prochlorperzine edisylate, ferrous sulfate, aminocaproic acid, mecamylamine hydrochloride, procainamide hydrochloride, amphetamine sulfate, methamphetamine hydrochloride, benzamphetamine hydrochloride, isoproterenol sulfate, phenmetrazine hydrochloride, bethanechol chloride, methacholine chloride, pilocarpine hydrochloride, atropine sulfate, scopolamine bromide, isopropamide iodide, tridihexethyl chloride, phenformin hydrochloride, methylphenidate hydrochloride, theophylline cholinate, cephalexin hydrochloride, diphenidol, meclizine hydrochloride, prochlorperazine maleate, phenoxybenzamine, thiethylperzine maleate, anisindone, diphenadione erythrityl tetranitrate, digoxin, isoflurophate, acetazolamide, methazolamide, bendroflumethiazide, chloropromaide, tolazamide, chlormadinone acetate, phenaglycodol, allopurinol, aluminum aspirin, methotrexate, acetyl sulfisoxazole, erythromycin, hydrocortisone, hydrocorticosterone acetate, cortisone acetate, dexamethasone and its derivatives such as betamethasone, triamcinolone, methyltestosterone, 17-S-estradiol, ethinyl estradiol, ethinyl estradiol 3-methyl ether, prednisolone, 17-∝-hydroxyprogesterone acetate, 19-nor-progesterone, norgestrel, norethindrone, norethisterone, norethiederone, progesterone, norgesterone, norethynodrel, aspirin, indomethacin, naproxen, fenoprofen, sulindac, indoprofen, nitroglycerin, isosorbide dinitrate, propranolol, timolol, atenolol, alprenolol, cimetidine, clonidine, imipramine, levodopa, chlorpromazine, methyldopa, dihydroxyphenylalanine, theophylline, calcium gluconate, ketoprofen, ibuprofen, cephalexin, erythromycin, haloperidol, zomepirac, ferrous lactate, vincamine, diazepam, phenoxybenzamine, diltiazem, milrinone, capropril, mandol, quanbenz, hydrochlorothiazide, ranitidine, flurbiprofen, fenufen, fluprofen, tolmetin, alclofenac, mefenamic, flufenamic, difuinal, nimodipine, nitrendipine, nisoldipine, nicardipine, felodipine, lidoflazine, tiapamil, gallopamil, amlodipine, mioflazine, lisinolpril, enalapril, enalaprilat, captopril, ramipril, famotidine, nizatidine, sucralfate, etintidine, tetratolol, minoxidil, chlordiazepoxide, diazepam, amitriptyline, and imipramine. Further examples are proteins and peptides which include, but are not limited to, insulin, colchicine, glucagon, thyroid stimulating hormone, parathyroid and pituitary hormones, calcitonin, renin, prolactin, corticotrophin, thyrotropic hormone, follicle stimulating hormone, chorionic gonadotropin, gonadotropin releasing hormone, bovine somatotropin, porcine somatotropin, oxytocin, vasopressin, GRF, prolactin, somatostatin, lypressin, pancreozymin, luteinizing hormone, LHRH, LHRH agonists and antagonists, leuprolide, interferons, interleukins, growth hormones such as human growth hormone, bovine growth hormone and porcine growth hormone, fertility inhibitors such as the prostaglandins, fertility promoters, growth factors, coagultion factors, human pancreas hormone releasing factor, analogs and derivatives of these compounds, and pharmaceutically acceptable salts of these compounds, or their analogs or derivatives. On the molecular level, the various forms of the beneficial agent may include uncharged molecules, molecular complexes, and pharmaceutically acceptable acid addition and base addition salts such as hydrochlorides, hydrobromides, acetate, sulfate, laurylate, oleate, and salicylate. For acidic compounds, salts of metals, amines or organic cations may be used. Derivatives such as esters, ethers and amides can also be used. A beneficial agent can be used alone or mixed with other agents. The beneficial agent may optionally include pharmaceutically acceptable carriers and/or additional ingredients such as antioxidants, stabilizing agents, permeation enhances, and the like. Animals to whom beneficial agents may be administered using systems of this invention include humans and other animals. The invention is of particular interest for application to humans and household, sport, and farm animals, particularly mammals. For the administration of beneficial agents to animals, the devices of the present invention may be implanted subcutaneously or intraperitoneally wherein aqueous body fluids are available to activate the osmotic agent. Devices of the invention may also be administered to the rumen of ruminant animals, in which embodiment the devices may further comprise a density element for maintaining the device in the rumen for extended periods of time of up to 120 days or longer. Density elements are well known in the art of drug delivery devices. The delivery devices of this invention are also useful in environments outside of physiological or aqueous environments. For example, the delivery devices may be used in intravenous systems (attached to an IV pump or bag or to an IV bottle, for example) for delivering beneficial agents to an animal, primarily to humans. They may also be utilized in blood oxygenators, kidney dialysis and electrophoresis, for example. Additionally, delivery devices of the present invention may be used in the biotechnology area, such as to deliver nutrients or growth regulating compounds to cell cultures. In such instances, activating mechanisms such as mechanical mechanisms are particularly useful. The beneficial agent may be any of the agents which are known to be delivered to the body of a human or an animal such as medicaments, vitamins, nutrients, or the like. The beneficial agent may also be an agent which is delivered to other types of aqueous environments such as pools, tanks, reservoirs, and the like. Included among the types of agents which meet this description are biocides, sterilization agents, nutrients, vitamins, food supplements, sex sterilants, fertility inhibitors and fertility promoters. While the invention has been described in detail with reference to preferred embodiments thereof, it will be apparent to one skilled in the art that various changes can be made, and equivalents employed without departing from the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims priority from German patent Application No. 201 07 778.7, titled PUNCTURE CANNULA, filed in Germany on May 8, 2001, the entire contents of which is incorporated by reference herein as though set forth in full. FIELD OF THE INVENTION [0002] The instant invention relates to a puncture cannula, particularly for nerve stimulation, comprising a steel cannula attached to a cannula hub and a cable extending through an insertion channel of the cannula hub and having a core connected to the steel cannula. BACKGROUND OF THE INVENTION [0003] European Patent 0 102 538 B1 discloses a puncturing and catheterizing device which is suited for the puncturing and catheterizing of nerve strings. This device comprises a steel cannula with a cannula hub provided at the distal end of the cannula. The steel cannula is connected to a cable by which an electric potential can be applied to the steel cannula. When the steel cannula, which has an exposed tip, is brought into a position close to a nerve, electrical pulses, which are applied to the cable by a suitable stimulation device, will cause a nerve stimulation, resulting in corresponding reflexes of the patient. In this manner, it can be verified whether the tip of the cannula has been guided sufficiently close to the selected nerve. Thereafter, an anesthetic agent can be injected either through the cannula or through a catheter which has been set by use of the cannula in order to perform local anesthesia. In the known device, the electrical connection of the core of the cable to the steel cannula is performed by winding the core around the cannula, or by soldering the core to the cannula and subsequently enmolding the connection. Such a connection technique is complicated and overly expensive. [0004] It is an object of the invention to provide a puncture cannula which is easily manufactured and guarantees a safe contact between the cable and the puncture cannula. SUMMARY OF THE INVENTION [0005] According to the instant invention, the hub of the cannula comprises a metallic clamping element which is formed with a first clamping slot for engaging the steel cannula and with a second clamping slot for engaging the core of the cable . By insertion of the clamping element into the hub of the cannula, the steel cannula and the core of the cable will be automatically positioned in their respective clamping slot to be tightly surrounded therein. In this manner, these two components are clamped into their desired positions at the same time, while the clamping of one component will not be affected by the other component. The clamping element is provided as a one-piece member, with its clamping slots arranged in such a configuration that the first clamping slot clamps the steel cannula when the second clamping slot clamps the core of the cable. Thus, the clamping slots have the same mutual distance as the steel cannula and the core of the cable and will be activated by displacing the clamping element. [0006] A considerable advantage of the invention resides in the simple and safe mounting process. By displacement of the clamping member, the steel cannula and the cable are fixed relative to each other and are also fixed relative to the hub of the cannula. It is also possible to perform the clamping prior to the attaching of the steel cannula in the hub of the cannula. In this case, an adhesive is inserted into a recess of the cannula hub after insertion of the clamping element. This adhesive will enter into all gaps to thus fasten the steel cannula in the hub of the cannula. Further, the adhesive serves as a surrounding electrical shielding for the cable and lends further stability the fixation of the cable. Further, the adhesive fulfills the function to cover all metallic parts which exist on or in the hub of the cannula, thus precluding the possibility that a person might inadvertently come into contact with any one of the current-carrying parts. [0007] According to a preferred embodiments of the invention, it is provided that the second clamping slot is formed with cutting edges adapted to penetrate an insulation of the cable. This obviates the need to first strip the cable and expose the core of the cable. When the clamping element is inserted into the hub of the cannula, the cutting of the cable insulation and the clamping of the core of the cable are performed automatically in the process. [0008] Preferably, the clamping slots are arranged behind each other in the clamping element, with a converging opening provided between the clamping slots so as to decouple the two clamping slots from each other. [0009] The puncture cannula of the invention is particularly suited for nerve stimulation. The instant puncture cannula is compatible with different techniques for using a cannula. Thus, for instance, an anesthetic agent can be injected directly through the steel cannula, or the steel cannula can be connected to a short catheter or a capillary tube. It is also possible to set a catheter via the puncture channel generated by the steel cannula, either with or without a guide wire. [0010] The clamping element can be of a design adapted to various diameters of steel cannulae and/or of cores of cables. [0011] A preferred embodiment of the invention will be described in greater detail hereunder with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0012] [0012]FIG. 1 is a longitudinal sectional view of an embodiment of the puncture cannula; [0013] [0013]FIG. 2 is a cross-sectional view along the line II-II of FIG. 1; and [0014] [0014]FIG. 3 is a view from the direction of the arrow III in FIG. 1. DETAILED DESCRIPTION OF THE INVENTION [0015] The puncture cannula comprises an elongate hollow steel cannula 10 attached to a cannula hub 11 of a plastic material. Steel cannula 10 consists of a tube provided with a nonconductive coating 12 . The tip of the cannula 10 (not shown) is exposed. [0016] Seated on a tubular connecting piece 13 of cannula hub 11 is a protective hose 9 which surrounds steel cannula 10 and extends beyond the length of cannula 10 to protect users from accidental injuries which might be caused by the tip of the cannula. The protective hose 9 can be withdrawn from the connecting piece 13 . [0017] The distal portion 10 a extends through a cavity or a recess 14 of the hub 11 of the cannula and ends in a cavity 15 which is closed by a hose connector 16 . A hose 17 , starting from hose connector 16 , is provided for the administration of an anesthetic agent which will then be injected into the patient's body through steel cannula 10 . [0018] An introduction channel 18 is arranged to enter the recess 14 of hub 11 and has a cable 19 extending therethrough. Introduction channel 18 is formed along a part 18 a of its length as a circumferentially closed bore, while another part 18 b of the length of channel 18 is formed as an open channel. The channel part 18 b terminates at an end wall 20 forming a stop face for the end of cable 19 . Cable 19 comprises a cable core 21 made of copper and an insulation 22 . Introduction channel 18 is oriented under an acute angle relative to the longitudinal axis of steel cannula 10 . A guideway 23 , formed for movement of a clamping element 24 therein, is arranged in a transverse direction relative to steel cannula 10 and cable 19 . Clamping element 24 comprises an elastic plate 25 made from spring steel. As illustrated in FIG. 2, this plate is formed with a first clamping slot 26 for steel cannula 10 and with a second clamping slot 27 for the core 21 of cable 19 . Both clamping slots 26 , 27 are arranged behind each other along a common axis and have a widened opening 28 arranged therebetween. Each of the clamping slots 26 , 27 has a tapering shape in the direction of insertion, i.e. from top to bottom in FIG. 2, so that a progressing insertion of the clamping element 24 into the cannula hub 11 will cause an increasingly stronger clamping action on the steel cannula 10 and the cable core 21 , respectively. The edges of second clamping slot 27 are cutting edges provided to cut through the insulation 22 of cable 19 , thus generating a safe electrical contact to the core 21 of cable 19 . [0019] Clamping slot 26 is delimited by wings 29 , 30 which can be bent about bending regions 31 for adaptation to different diameters of steel cannulae 10 . In FIG. 1, one of these wings, 29 , is shown as bent in outward direction. [0020] Clamping element 24 comprises a plate which, however, does not necessarily have to be flat. The plate is guided in a linear guideway 23 for displacement between a clamping position and a release position. [0021] When the steel cannula 10 and the cable 19 are to be mounted, the steel cannula 10 is inserted into the channel of cannula hub 11 which is provided for this purpose, and the cable 19 along with its insulation 22 is introduced into insertion channel 18 . Subsequently, clamping element 24 is inserted into guideway 23 and pushed into the same until reaching the end stop, while the clamping slot 26 exerts a clamping grip on steel cannula 10 and the clamping slot 27 cuts through the insulation 22 into the core 21 of cable 19 . The hub 11 of cannula 10 is then positioned in such an orientation that the recess 14 is facing upwards. In this condition, FIG. 3 represents a plan view from above. Next, a liquid adhesive 33 is filled into recess 14 . This adhesive will occupy the recess 14 completely. The adhesive enters into the annular gap between steel cannula 10 and cannula hub 11 and into the annular gap between introduction channel 18 and the cannula hub 11 and will after hardening also keep the clamping element 24 fixed in position. Thus, a sole adhesion process is sufficient to fix all of the components relative to each other and to close them in a tightly sealed manner. Also the entrance orifice 34 of guideway 23 is closed by adhesive and sealed so that the whole clamping element 24 is embedded in adhesive material. Thus, no electrically conductive components are accessible from the outside.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. patent application Ser. No. 10/387,673, filed Mar. 12, 2003, soon to issue as U.S. Pat. No. 7,036,575, which claims the benefit of U.S. Provisional Application No. 60/365,438, filed Mar. 19, 2002; the disclosures of which applications are incorporated by reference as if fully set forth herein. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable BACKGROUND OF THE INVENTION This invention relates to bed warmers and bed coolers. In particular, the invention relates to bed warmers and bed coolers that heat or cool the interior of a bed via the use of a directed flow of warm air or cool air. Bed warmers of various designs have been used for centuries to alleviate the discomfort of getting into a cold bed. More recently, devices have been created that both warm and cool the interior of a bed in an attempt to provide totally controlled temperature conditions within the bed. The background art is characterized U.S. Pat. Nos. 1,142,876; 2,259,712; 2,461,432; 2,560,349; 2,695,413; 3,101,488; 3,230,556; 3,444,922; 3,713,182; 4,151,658; 4,777,802; 4,867,230; 4,939,804; 4,984,316; 5,300,100; 5,730,120; 5,842,286; 5,887,303; 5,956,863; 6,285,828; 6,473,920 and 6,711,767 the disclosures of which patents are incorporated by reference as if fully set forth herein. The background art is also characterized by United Kingdom Patent Nos. 1 213 123; GB 2 135 860 A; GB 2 192 118 A; and GB 2 227 943 A; and by France Patent Nos. 2 589 343; and 2 673 822. Sweetland in U.S. Pat. No. 2,259,712 discloses a bed warmer with a thermostat for control of the temperature of the heating coil or heated air. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Inglis in U.S. Pat. No. 2,560,349 discloses an air conditioner for heating or cooling a bed. The device includes a thermostat for control of the temperature of the heated air. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Ter Mat is U.S. Pat. No. 2,695,413 discloses a ventilating device for beds. The device includes a thermostat for control of the temperature of the bed. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Another device, disclosed U.S. Pat. No. 3,230,556 issued to Shippee, discloses a construction for maintaining a controlled temperature environment in a bed. It consists of a shaped air distributing nozzle, a separate unit with a fan for inducing air flow, a heating means for increasing the temperature of the air and controls for the unit including a clock for timed control, a heat regulator and a fan switch. This invention is limited in that no heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Another device, disclosed in U.S. Pat. No. 3,444,922 issued to Dingman, shows an apparatus for regulating the conditions of a bed by passing air about the occupant of the bed. The apparatus includes a distributor head connected to a separate cabinet containing an air pump, a temperature exchange chamber or plenum, a remote hand control box and may also include sensors to monitor temperature and humidity. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. McNeal in U.S. Pat. No. 3,713,182 discloses a bedclothes elevator and bed warmer. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Hibino et al. in U.S. Pat. No. 4,151,658 disclose a bed clothes drying device. This invention is limited in that no heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Yet another device, shown in U.S. Pat. No. 4,777,802 to Feher, describes a modified blanket assembly construction containing cavities or chambers through which warm or cool air is directed. Peltier effect elements are selectively energizable in a separate unit to heat or cool air provided to the blanket assembly cavities. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Voss in U.S. Pat. No. 4,867,230 disclose a convection blanket warmer. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Simpson et al. in U.S. Pat. No. 4,984,316 disclose a bed warmer that is used in conjunction with a hair drier. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Hickle et al. in U.S. Pat. No. 5,300,100 disclose a body warmer. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Cantor in U.S. Pat. No. 5,842,286 discloses a multi-functional hand-held hair drier that includes a barrel that discharges heated air in an axial direction and in two transverse directions. This invention is limited in that no thermostat, timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Raith in U.S. Pat. No. 5,887,303 discloses a bed warmer apparatus. This invention is limited in that no timer or heat storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Allen in U.S. Pat. No. 5,956,863 discloses a hair dryer apparatus and method. This invention is limited in that no thermostat, timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Cafaro in U.S. Pat. No. 6,285,828 discloses an infrared hair dryer heater. This invention is limited in that no timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Foster et al. in United Kingdom Patent No. 1 213 123 disclose a blanket for effecting heating and cooling of beds. This invention is limited in that no thermostat, timer or heat/cold storage is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Matossian et al. in United Kingdom Patent No. GB 2 135 860 A disclose an electric bed warmer. This invention is limited in that no air movement means is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Mappelback et al. in United Kingdom Patent No. GB 2 192 118 A disclose a liquid-filled bed warmer. This invention is limited in that no air movement means is provided. Moreover, the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Simpson et al. in United Kingdom Patent No. GB 2 227 943 A disclose bed warmer. The disclosure of this patent is substantially the same at that of U.S. Pat. No. 4,984,316, described above. Girard in France Patent No. FR2589343 discloses bed drying device. This invention is limited in that the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. Georges in France Patent No. FR2673822 discloses a bed warmer. This invention is limited in that the configuration of the unit is not such that the unit can be placed between the bottom sheet and bed cover with its handle overlapping the bed cover. While background art devices may achieve the basic objective of controlling the air temperature within the bed, they share several disadvantages. First, they have multiple parts that, in order to function properly, may need to be assembled in somewhat complex configurations and to be precisely adjusted, which can make setting up the devices cumbersome and time consuming. Second, some of these devices contain or are inter-connected by electrical wires that rest in close proximity to the bed occupant during sleep, creating the possibility of shock or even electrocution. Third, in most cases, use of these devices requires that the bed coverings be removed, the device assembled and installed and the bed re-made. This makes them complicated and inconvenient to use, especially in the circumstance where a single device is to be used with multiple beds. Fourth, these devices are designed for continuous operation during the sleep cycle. It has been shown that the best conditions for sleep include absolute quiet and stillness. In addition, the healthiest state for the sleeping body has been demonstrated to be one in which the body is allowed to maintain it own optimal temperature via homeostasis, as opposed to continuously adjusting to imposed material or moving air temperatures. Thus, conditions may be created by these devices that are actually energetically stressful and counter to relaxing sleep, such as noise, vibration, excessive heat and air disturbance around or across the body. What is needed is an apparatus and method for modifying the temperature of bedding that is convenient to use and that does not induce stress in its user. What is also needed is an apparatus that is easily moved and repositioned and that can be used with multiple beds. What is also needed is an apparatus that is capable of inflating a bed by filling the space between the bottom sheet and covers with a small volume of hot air, creating a microenvironment that contributes to the user's sensation of comfort and deep relaxation. BRIEF SUMMARY OF THE INVENTION The present invention recognizes and addresses particular disadvantages of prior art principles and constructions. Accordingly, it is an object of the present invention to provide enhanced and highly efficient warming and/or cooling of a bed environment. It is an object of this invention to provide a simple way to obviate the need for cumbersome warming/cooling envelopes, hoses, tubes, blankets or dangerous electrical wires in or over the bed, by operating as a single easily movable unit without additional separate external attachments. It is a further object of this invention to allow the user to maintain the comfortable, familiar bed coverings to which they are accustomed. By modifying the temperature of those coverings themselves as well as the air envelope created inside them, the total bed environment is made immediately comfortable to the user. It is a further object of this invention to easily create pre-heated or pre-cooled microenvironments within multiple undisturbed beds, without removal or disturbance of bed linens or coverings. It is also an object of this invention to introduce temperature-conditioned air into the bed by simply forcing the air into the space between the bed linens (e.g., between the bottom sheet and the bed covers). When activated, the pressure of the entering air causes the bed covers themselves to inflate slightly, thereby automatically distributing the warmed or cooled air to all parts of the bed. Another object of preferred embodiment of this invention is to complete an operational cycle and bring the bed interior to a comfortable temperature, before the occupant enters the bed. After the device is removed, the resting body, with suitable insulating or air permeable coverings, then effortlessly maintains a comfortable temperature through the principle of homeostasis. This allows optimal conditions of silence and stillness to be maintained during the sleep phase, thereby enabling and facilitating deep relaxation and restful sleep. Yet another object of preferred embodiments of this invention is to provide air delivery means, comprised of a thermal mass material that retains the heat or cold supplied during activation, which may then be detached from the heating/cooling section. Preferably, the air delivery means then remains in the bed with the occupant and is placed near or against the body to provide additional passive warmth or cooling via thermal radiation and direct body contact. Yet another object of preferred embodiments of this invention is to create a microenvironment within the bed that makes possible the maintenance of lower ambient-air temperatures in the bedroom, thereby conserving energy and lessening the desiccating effects of dry and overheated air during sleep. Another object of preferred embodiments of this invention is to provide air delivery means, in the form of a stuffed animal, toy or other object which may be utilized after the operating cycle is completed as a detachable child's toy or novelty object. Preferably, the child's toy or novelty object contains thermal mass material which enables it to retain warmth or cold, thereby providing a safe and comforting object for the bed occupant to place against his or her body as a further aid to relaxation and sound sleep. It is also an object of preferred embodiments of this invention to introduce aromatic, herbal-conditioned air into the bed as an additional factor conducive to relaxation and restful sleep. It is also an object of preferred embodiments of this invention to utilize a twenty-four hour digital timer to allow the device to be set up beforehand at any hour of the day, and thereby to automatically activate and run through a timed operational cycle at the hour that the user has selected. In a preferred embodiment, the invention is a device (Warm•Wand™) for modifying the temperature of bedding (e.g., a bottom sheet and a bed cover), said device comprising: a housing having an exterior and an interior, said housing defining an air intake, an air plenum and an air outlet; a fan (or other air moving device) mounted in said housing for moving air in said air intake, through said plenum and out said air outlet; a heat transfer element mounted within said housing for modifying the temperature of the air entering said air intake (e.g., conditioning the air); a temperature sensor mounted in said plenum for sensing the temperature of the air moving through said plenum; a control circuit connected to said temperature sensor, said control circuit being operative to maintain the temperature of air moving through said plenum at or below a selected temperature (e.g., acting as a thermostat); a timer mounted within (or on) said housing, said timer being operative to activate said fan and heat transfer element upon being turned on by means of a timer dial mounted on the exterior of said housing and to deactivate said fan and heat transfer element after a selected amount of time; and an elongated air delivery section having two ends and defining an air entrance at one end, a primary air exit at the other end and a plurality of secondary air exits adjacent to the other end, said air entrance being adapted to connect to said air outlet; wherein said elongated air delivery section has a longitudinal axis and comprises a flattened portion; wherein said primary air exit is situated at the terminus of said flattened portion and is adapted to discharge air substantially parallel to said longitudinal axis and far enough beneath a bed cover to cause the bedding to inflate; and wherein said plurality of secondary air exits are situated within said flattened portion and are adapted to discharge air substantially perpendicular to said longitudinal axis. Preferably, the device further comprises a handle attached to said housing. Preferably, handle is attached to the top rear of said housing and is forward projecting (e.g., projecting toward the air outlet and rendering the device U-shaped). Preferably, the heat transfer device is a heating element (e.g., a resistance coil). Preferably, the housing also defines a rear-facing air exhaust, said heat transfer device is a thermoelectric module that is adapted to heat and cool the air entering said air intake and said device further comprises a switch for switching the device between heating and cooling the air discharged from the device. Preferably, the device further comprises a power cord for supplying power to the device. Preferably, the elongated air delivery section is attachable to and detachable from said housing by means of a bayonet joint there between. Preferably, the outside of said air delivery section is configured to resemble an animal, toy or other object. Preferably, the air exit is the mouth of the animal or opening on the front of the toy or object. Preferably, the selected amount of time is variable between about one minute and about five minutes. In another preferred embodiment, the invention is a device for modifying the temperature of bedding, said device comprising: a housing having an exterior and an interior, said housing defining an air intake, an air plenum and an air outlet; a fan mounted in said housing for moving air in said air intake, through said plenum and out said air outlet; a heat transfer element mounted within said housing for modifying the temperature of the air entering said air intake; a temperature sensor mounted in said plenum for sensing the temperature of the air moving through said plenum; a control circuit connected to said temperature sensor, said control circuit being operative to maintain the temperature of air moving through said plenum at or below a selected temperature; a timer mounted within said housing, said timer being operative to activate said fan and heat transfer element upon being turned on by means of a timer dial mounted on the exterior of said housing and to deactivate said fan and heat transfer element after a selected amount of time; and an elongated, detachable air delivery section having two ends and defining an air entrance at one end and a primary air exit at the other end, said air entrance being adapted to connect to said air outlet, said elongated air delivery section comprising a thermal gel medium having at least one air channel there through, said air channel connecting said air entrance and said air exit. Yet another preferred embodiment of the invention is a device for modifying the temperature of bedding, said device comprising: a housing having an exterior and an interior, said housing defining an air intake, an air plenum and an air outlet; a fan mounted in said housing for moving air in said air intake, through said plenum and out said air outlet; a heat transfer element mounted within said housing for modifying the temperature of the air entering said air intake; a temperature sensor mounted in said plenum for sensing the temperature of the air moving through said plenum; a control circuit connected to said temperature sensor, said control circuit being operative to maintain the temperature of air moving through said plenum at or below a selected temperature; a timer mounted within said housing, said timer being operative to activate said fan and heat transfer element upon being turned on by means of a timer dial mounted on the exterior of said housing and to deactivate said fan and heat transfer element after a selected amount of time; and an elongated, detachable air delivery section having two ends and defining an air entrance at one end and a primary air exit at the other end, said air entrance being adapted to connect to said air outlet, said elongated air delivery section comprising a thermal gel medium having a plurality of air channels there through, said air channels connecting said air entrance and said air exit. Preferably, the housing also defines a rear-facing air exhaust, said heat transfer device is a thermoelectric module that is adapted to heat and cool the air entering said air intake and said device further comprises a switch for switching the device between heating and cooling the air discharged from the device. Preferably, the elongated air delivery section is attachable to and detachable from said housing by means of a bayonet joint there between, said bayonet joint comprising a plurality of lugs. Preferably, the paths of said air channels are tortuous. In a further preferred embodiment, the invention is a device for modifying the temperature of bedding, said bedding comprising a bottom sheet and a cover, said device comprising: an air conditioning section having an exterior and an interior having an insulating liner, said air conditioning section defining an air intake, an air plenum and an air outlet and having a U-shaped slot that is adapted to receive an edge of said cover; a fan mounted in said air conditioning section for moving air in said air intake, through said plenum and out said air outlet; a heat transfer element mounted within said air conditioning section for modifying the temperature of the air entering said air intake; a temperature sensor mounted on said heat transfer element for sensing its temperature; a control circuit connected to said temperature sensor, said control circuit being operative to maintain the temperature of the heat transfer element at or below a selected temperature; a timer mounted within said air conditioning section, said timer being operative to activate said fan and heat transfer element upon being turned on by means of a timer dial mounted on the exterior of said air conditioning section and to deactivate said fan and heat transfer element after a selected amount of time; and an elongated air delivery section having two ends and defining an air entrance at one end, a primary air exit at the other end and a plurality of secondary air exits adjacent to the other end, said air entrance being adapted to connect to said air outlet. In another preferred embodiment, the invention is a device for modifying the temperature of bedding, said bedding comprising a bottom sheet and a cover, said device comprising: an air conditioning section comprising a body portion and a handle portion, said an air conditioning section having an exterior surface that is adapted to receive an edge of said cover between said body portion and said handle portion and an interior surface defining an air intake, an air plenum and an air outlet; a fan mounted in said air conditioning section for moving air in said air intake, through said plenum and out said air outlet; a heat transfer element mounted within said air conditioning section for modifying the temperature of the air entering said air intake; a temperature sensor mounted on said heat transfer element for sensing its temperature; a control circuit connected to said temperature sensor, said control circuit being operative to maintain the temperature of the heat transfer element at or below a selected temperature; a timer mounted within said air conditioning section, said timer being operative to activate said fan and heat transfer element upon being turned on by means of a timer dial mounted on the exterior of said air conditioning section and to deactivate said fan and heat transfer element after a selected amount of time; and an elongated air delivery section having two ends with an air entrance at one end and a primary air exit at the other end, said air entrance being adapted to connect to said air outlet. In a preferred embodiment the device further comprises a plurality of secondary air exits adjacent to the other end. In another preferred embodiment, the invention is a device for modifying the temperature of bedding, said device comprising: housing means having an exterior and an interior having an insulating liner, said housing means defining an air intake, an air plenum and an air outlet; means for moving air (e.g., a fan or blower) mounted in said housing, said means for moving air being operative to move air in said air intake, through said plenum and out said air outlet; means for heat transfer mounted within said housing means, said means for heat transfer being operative to modify the temperature of the air entering said air intake; means for temperature sensing mounted on said means for heat transfer, said means for temperature sending being operative to sense the temperature of the means for heat transfer; means for controlling connected to said means for temperature sensing, said means for controlling being operative to maintain the temperature of the means for heat transfer at or below a selected temperature; means for timing mounted within said housing means, said means for timing being operative to activate said means for moving air and said means for heat transfer upon being turned on by means of a timer dial mounted on the exterior of said housing means and to deactivate said means for moving air and said means for heat transfer after a selected amount of time; and means for air delivery, said means for air delivery being elongated, having two ends and defining an air entrance at one end, a primary air exit at the other end and a plurality of secondary air exits adjacent to the other end, said air entrance being adapted to connect to said air outlet. In preferred embodiments, the invention is also a method. In a preferred embodiment, the invention is a method for modifying the temperature of bedding comprising a bottom sheet and a cover, said method comprising: placing a device disclosed herein within the bedding with said handle on top of the cover and said outlet below the cover; and setting the timer to cause the device to operate, thereby inflating the bedding. Preferably, the method further comprises detaching the air delivery section from the housing; leaving the air delivery section within the bedding; and removing the housing from the bedding. In another preferred embodiment, the invention is a method for modifying the temperature of bedding comprising a bottom sheet and a cover having an edge, said method comprising: a step for placing a device of disclosed herein within the bedding with the edge of the cover being disposed in said U-shaped slot and said outlet being disposed below the cover; and a step for setting the timer to cause the device to operate. Preferably, the method further comprises: a step for detaching the air delivery section from the housing; a step for leaving the air delivery section within the bedding; and a step for removing the housing from the bedding. In a preferred embodiment, the invention is an apparatus for modifying the temperature of bedding, said apparatus comprising: an air conditioning section comprising a housing having an air intake and an air exit, an air conditioning element, a fan, a thermostat and a timer; and a air delivery section having an air entrance that is attachable to and detachable from said air exit, said air delivery section comprising an elongated neck portion and a air diffuser portion; wherein said housing comprises a body and a handle with a slot there between that is adapted to support the edge of a bedcover and prevent its covering of said air intake; and wherein said elongated neck portion is adapted to position said diffuser sufficiently distant from said edge so that inflation of the bedding occurs upon activation of the fan. Another preferred embodiment of the invention is a device for warming or cooling a bed, the device comprising: a (rear) housing, defining an air intake, interior air plenums and one or more air exits; a fan or other means for moving air into said air intake, through said air plenums and out said air exits; a heating element that functions to increase the temperature of the air that has entered said air intake; a temperature sensor attached to said heating element that monitors the temperature of said element; self-regulating safety temperature circuitry connected to said temperature sensor that automatically adjusts said heating element such that said heating element and/or the heated air remains below a specific safety temperature; a timer that can be set for a cycle such that said timer activates said device for a specified number of minutes or seconds and automatically deactivates said device when said timer has completed said cycle; an air delivery section, being one of said two connected sections of said device, serving as a means for moving air directionally forward and out said air exits. Preferably, said heating element is a thermoelectric heating/cooling element that either increases or decreases the temperature of the air that has entered said air intake, depending on the setting of a switch that reverses the polarity of said thermoelectric element. Preferably, the interior of said housing is divided into a plenum that directs conditioned air toward the front exits and a plenum that directs exhaust air toward the rear of said device. Preferably, the (front) air delivery section is partly comprised of a thermal mass substance, and may be detached after operation of said device and retained in the bed to provide additional heating. Preferably, the front air delivery section is in the form of a child's toy containing thermal mass material, and may be detached after operation of said device and left with a child to sleep with to provide an additional level of comfort. In another preferred embodiment, the invention is a self-contained, forced air bed warmer or bed warmer/cooler which safely and efficiently pre-heats or pre-cools the interior sheets and covers of a bed to provide a comfortable micro-environment that facilitates relaxation into restful sleep on cold or hot nights. Preferred embodiments comprise a heating/cooling element section and an air delivery section that lock together via a bayonet type joint. Preferably, the heating/cooling element section is generally cylindrical with a handle connected at a single point at the top rear of the section and projecting forward. This handle preferably provides a means of easily manipulating the device as well as acts as a catch to prevent blankets or covers from sliding over the rear body/air intake and blocking the flow of air. In preferred embodiments, a portion of the handle also functions as an exit for a reverse air plenum in the heating/cooling version. The heating/cooling section preferably contains a high-efficiency fan or device for moving air and an element for heating or cooling air. These parts function together to create a flow of hot or cool air that travels through the housing and out the openings in the air delivery section. The air delivery sections preferably generally resemble a flattened and flared tube, a flat semi-flexible oval or a child's stuffed toy animal. The flat oval air delivery section is preferably comprised of a semi-flexible thermal gel that acts as a thermal mass to retain heat or cold from the conditioned air directed through it. This air delivery section is designed to be detached from the heating/cooing section after deactivation of the device, and to remain in the bed with the occupant to provide additional passive radiant and conductive warming or cooling. The child's toy air delivery section is preferably constructed with an internal layer of thermal gel that similarly retains heat and cold. The child's toy air delivery section may also be detached from the heating/cooling section after deactivation and left with the child to sleep with to provide an additional level of comfort as a further aid to sound sleep. Auxiliary holes are preferably provided in the air delivery section to allow a wider distribution of the air exiting the device and provide an alternative airflow in the event that the primary exit becomes obstructed. Preferred embodiments of the device comprise a timer mechanism that can be set such that the device activates for a period of one to five minutes and then automatically deactivates. Preferably, the device also contains a thermal sensor and self-regulating safety temperature circuitry that automatically adjusts the heating/cooling element and/or the heated air (when in the heating mode) such that they remain below a specific safety temperature regardless of the amount of air flowing through the device. In a preferred embodiment, the invention is a self-contained forced air bed warmer or bed warmer/cooler which safely and efficiently pre-heats or pre-cools the interior sheets and covers of a bed to provide a comfortable micro-environment that will facilitate relaxation into restful sleep on cold or hot nights. Preferably, it is an easily moveable, self-contained, hand-held appliance constructed of lightweight injection molded plastic. In preferred embodiments, the design and position of the handle of the device maintain the device in an optimal position relative to the bed covers and for unimpeded airflow. If one attempted to use a background art device for this purpose, it would not stay in position and the covers would invariably block the air intake, causing overheating, possible fire hazard and electrical cutoff or possible short circuit. Preferred embodiments of the device have an insulated air delivery section that is of sufficient length to conduct the warmed air into the mid-section of the bed. Background art devices do not have the length to perform this function and so would conduct very little air into the bed interior. In preferred embodiment, the air delivery section is a progressively flattened, flared and perforated tube, and represents an optimal shape for slipping between bed covers. Background art devices maintain near cylindrical profiles and would be ineffective for this purpose. Preferably, the device has a manual set minute timer and automatic safety temperature control circuitry that allows the device to be activated and left to safely complete the heating cycle unattended. Background art devices have no such features and thus are unsafe for this purpose. In a preferred embodiment, the invention is a self-contained forced air bed warmer that comprises means wherein elements such as aromatic herbal packets may be suspended in or introduced into the air moving through the device such that the air is modified or further conditioned by those elements, thereby adding aromatic or olfactory influences that further facilitate relaxation into restful sleep. Preferred embodiments of the device further comprise a twenty-four hour digital timer mechanism that can be set such that the device activates either immediately or automatically at any specified time within a twenty-four hour period for a period up to ten minutes and then automatically deactivates. Setting of the timer is preferably easily done via pushbuttons located on the exterior of the device housing. In a preferred embodiment, the invention is a device for modifying the temperature of bedding comprising a bed cover, said device comprising: a housing having an exterior and an interior, said housing defining an air intake, an air plenum and an air outlet; a fan mounted in said housing for moving air in said air intake, through said plenum and out said air outlet; a heat transfer element mounted within said housing for modifying the temperature of the air entering said air intake; a temperature sensor mounted in said plenum for sensing the temperature of the air moving through said plenum; a control circuit connected to said temperature sensor, said control circuit being operative to maintain the temperature of air moving through said plenum at or below a selected temperature; a timer mounted within said housing, said timer being operative to activate said fan and heat transfer element either immediately or at any specified time within a twenty-four hour period upon being turned on or set by means of either a timer dial or a plurality of pushbuttons and a display panel and to deactivate said fan and heat transfer element after a selected amount of time; and an elongated air delivery section having two ends and defining an air entrance at one end, a primary air exit at the other end and a plurality of secondary air exits adjacent to the other end, said air entrance being adapted to connect to said air outlet; wherein said elongated air delivery section has a longitudinal axis and comprises a flattened portion; wherein said elongated air delivery section comprises means for suspending an aromatic element in and introducing an aromatic substance into the air moving through said elongated air delivery section such that said air is modified or further conditioned by said elements; wherein said primary air exit is situated at the terminus of said flattened portion and is adapted to discharge air substantially parallel to said longitudinal axis and far enough beneath a bed cover to cause the bedding to inflate; and wherein said plurality of secondary air exits are situated within said flattened portion and are adapted to discharge air substantially perpendicular to said longitudinal axis. In a further preferred embodiment, the invention is a device for modifying the temperature of bedding, said bedding comprising a bottom sheet and a cover, said device comprising: an air conditioning section having an exterior and an interior having an insulating liner, said air conditioning section defining an air intake, an air plenum and an air outlet and having a U-shaped slot that is adapted to receive an edge of said cover; a fan mounted in said air conditioning section for moving air in said air intake, through said plenum and out said air outlet; a heat transfer element mounted within said air conditioning section for modifying the temperature of the air entering said air intake; a temperature sensor mounted on said heat transfer element for sensing its temperature; a control circuit connected to said temperature sensor, said control circuit being operative to maintain the temperature of the heat transfer element at or below a selected temperature; a timer mounted within said housing, said timer being operative to activate said fan and heat transfer element either immediately or at any specified time within a twenty-four hour period upon being turned on or set by means of either a timer dial or a plurality of pushbuttons and a display panel and to deactivate said fan and heat transfer element after a selected amount of time; and an elongated air delivery section having two ends and defining an air entrance at one end, a primary air exit at the other end and a plurality of secondary air exits adjacent to the other end, said air entrance being adapted to connect to said air outlet. In yet another preferred embodiment, the invention is a device for modifying the temperature of bedding, said bedding comprising a bottom sheet and a cover, said device comprising: an air conditioning section comprising a body portion and a handle portion, said an air conditioning section having an exterior surface that is adapted to receive an edge of said cover between said body portion and said handle portion and having an interior surface defining an air intake, an air plenum and an air outlet; a fan mounted in said air conditioning section for moving air in said air intake, through said plenum and out said air outlet; a heat transfer element mounted within said air conditioning section for modifying the temperature of the air entering said air intake; a temperature sensor mounted on said heat transfer element for sensing its temperature; a control circuit connected to said temperature sensor, said control circuit being operative to maintain the temperature of the heat transfer element at or below a selected temperature; a timer mounted within said housing, said timer being operative to activate said fan and heat transfer element either immediately or at any specified time within a twenty-four hour period upon being turned on or set by means of either a timer dial or a plurality of pushbuttons and a display panel and to deactivate said fan and heat transfer element after a selected amount of time; and an elongated air delivery section having two ends with an air entrance at one end and a primary air exit at the other end, said air entrance being adapted to connect to said air outlet. In another preferred embodiment, the invention is a device for modifying a bedding environment, said bedding comprising a bottom sheet and a cover, said device comprising: an air conditioning section comprising a body portion and a handle portion, said an air conditioning section having an exterior surface that is adapted to receive an edge of said cover between said body portion and said handle portion and having an interior surface defining an air intake, an air plenum and an air outlet; a fan mounted in said air conditioning section for moving air in said air intake, through said plenum and out said air outlet; a heat transfer element mounted within said air conditioning section for modifying the temperature of the air entering said air intake; a temperature sensor mounted on said heat transfer element for sensing its temperature; a control circuit connected to said temperature sensor, said control circuit being operative to maintain the temperature of the heat transfer element at or below a selected temperature; a timer mounted within said housing, said timer being operative to activate said fan and heat transfer element either immediately or at any specified time within a twenty-four hour period upon being turned on or set by means of either a timer dial or a plurality of pushbuttons and a display panel and to deactivate said fan and heat transfer element after a selected amount of time; and an elongated air delivery section having two ends with an air entrance at one end and a primary air exit at the other end, said air entrance being adapted to connect to said air outlet; wherein said elongated air delivery section comprises means for introducing an aromatic substance into the air moving through said elongated air delivery section such that said air is modified or further conditioned. Further aspects of the invention will become apparent from consideration of the drawings and the ensuing description of preferred embodiments of the invention. A person skilled in the art will realize that other embodiments of the invention are possible and that the details of the invention can be modified in a number of respects, all without departing from the concept. Thus, the following drawings and description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS The features of the invention will be better understood by reference to the accompanying drawings which illustrate presently preferred embodiments of the invention. In the drawings: FIG. 1 is a right side perspective view of a device constructed in accordance the invention, designed to produce heating only, showing a cutaway view of the interior components, wherein the heating element section is attached to a basic air delivery section. FIG. 2 is a right side perspective view of a device constructed in accordance the invention, designed to produce both heating and cooling, showing a cutaway view of the interior components, wherein the heating/cooling element section is attached to a thermal gel air delivery section. FIG. 3 is a right side perspective view of the device of FIG. 1 , showing an exterior view wherein a heating element section is attached to a basic air delivery section. FIG. 4 is a right side perspective view of the device of FIG. 1 , showing an exterior view wherein a heating element section is attached to a child's toy air delivery section, in which a cutaway view shows the interior construction of the toy air delivery section. FIG. 5 is a right side perspective view of the device of FIG. 2 showing an exterior view of a heating/cooling element section separated from a thermal gel air delivery section and a basic air delivery section. Also shown are the bayonet lugs for the locking joint. FIG. 6 is a right side perspective view of the device of FIG. 1 showing an exterior view of a heating element section separated from a child's toy air delivery section and a basic air delivery section. Also shown are the bayonet lugs for the locking joint. FIG. 7 is a three-dimensional (3D) rendering of the device of FIG. 1 showing a camera/perspective view in FIG. 7A , a top view in FIG. 7B , a side view in FIG. 7C , a front view in FIG. 7D and a back view in FIG. 7E . FIG. 8 is a 3D cut-away rendering of the device of FIG. 1 in use. In this view, the device is situated between the bed cover (which has a portion cut away for clarity) and the bottom sheet. FIG. 9 is a right side perspective view of another preferred embodiment of the device, showing an exterior view of a heating element section with digital timer, pushbuttons and liquid crystal display (LCD) panel, separated from an herbal infuser air delivery section. FIG. 10 is a right side perspective view of a preferred embodiment of the herbal infuser air delivery section, showing a cutaway view of the interior structure, displaying the perforated herbal infuser basket, the infuser enclosure cover in the open position and a shaped herbal packet that is insertable in the enclosure. The following reference numerals are used to indicate the parts and environment of the invention on the drawings: 1 a heating element section, heating/cooling element section, air conditioning section, housing, main body, body portion 1 b basic air delivery section 1 c stuffed toy air delivery section 1 d thermal gel air delivery section 1 e herbal infuser air delivery section 2 handle 3 secondary air exits 4 primary air exit 5 air intake, rear air intake 6 heat-resistant liner 8 heating coil, heat exchanger, heat transfer element 9 timer 9 a external timer dial, timer dial 10 fan unit, fan, blower, other device for moving air 11 temperature sensor 12 bayonet type joint 13 bayonet lugs 14 lower heat transfer element 15 thermoelectric module, thermoelectric element 16 upper reverse air plenum 17 upper heat transfer element 18 reverse air exit, air exhaust 19 power cord 20 electrical plug 21 polarity switch 23 thermal gel medium 24 thermal gel air channels 25 stuffed toy covering 26 flexible, heat-resistant tube 30 bottom sheet 32 cover 34 slot, U-shaped slot 35 herbal infuser enclosure basket, internal enclosure, perforated herbal infuser enclosure 36 herbal infuser enclosure cover, infuser enclosure cover, enclosure door 37 herbal infuser basket perforations, enclosure perforations 38 herbal packet, shaped herbal packet 39 digital timer pushbuttons, exterior pushbuttons 40 digital timer unit 41 digital timer LCD panel, LCD panel DETAILED DESCRIPTION OF THE INVENTION Referring to FIG. 1 , a preferred embodiment of the invention is presented. This embodiment is designed to produce heating only and preferably comprises two main sections: heating element section 1 a and air delivery section 1 b which lock together via bayonet type joint 12 . Heating element section 1 a is generally cylindrical, with air intake 5 on one (rear) end and forward-projecting handle 2 attached at the top rear. The front of elongated air delivery section 1 b is flattened into a flare that terminates in primary air exit 4 . Patterns of holes on the top and bottom of the front flare serve as secondary air exits 3 , providing auxiliary air exits for the device or alternative exits in the event that primary exit 4 becomes obstructed. Both heating element section 1 a and air delivery section 1 b are preferably constructed of a plastic, more preferably an injection-molded thermoplastic. Mounted inside heating element section 1 a are the following: high efficiency fan or other device for moving air 10 , heating coil 8 and temperature sensor 11 . Temperature sensor 11 is used to monitor the temperature of heating coil 8 and/or the air heated by heating coil 8 and produces signals that are processed by a control circuit (not shown) that is operative to maintain the temperature of heating coil 8 and/or the air heated by heating coil 8 at or below a selected temperature (e.g., 100 F). A manual set timer 9 is preferably mounted on the right side of the casing of fan 10 . Lining the entire inside of the plastic casing of both heating element section 1 a and air delivery section 1 b is heat-resistant insulating liner 6 . Power cord 19 terminated in standard 120-volt wall plug 20 preferably connects to the device circuitry (not shown) through the left side of handle 2 . Referring to FIG. 2 , another preferred embodiment of the invention is presented. This embodiment is designed to produce both heating and cooling and comprises two main sections: heating/cooling element section 1 a and thermal mass air delivery section 1 d that lock together via bayonet type joint 12 . Heating/cooling element section 1 a is generally cylindrical with air intake 5 on one end and forward projecting handle 2 attached at the top rear. Air delivery section 1 d generally defines a flattened oval composed of a semi-rigid thermal gel through which run a plurality of tortuous air passages 24 terminating at primary air exit 4 . Mounted inside heating/cooling element section 1 a are the following: high efficiency fan or device for moving air 10 , thermoelectric module 15 , upper heat transfer element 17 , lower heat transfer element 14 and temperature sensor 11 . Manual timer dial 9 and polarity switch 14 are preferably mounted on the right side of the casing of fan 10 . Heating/cooling element section 1 a is divided into two separate chambers, one located above and one located below thermoelectric element 15 . Top chamber 16 forms an airtight reverse air plenum that terminates at reverse air exit 18 in the back end of handle 2 . Lining the inside of the preferably plastic casing of heating/cooling element section 1 a is heat-resistant, insulating liner 6 . Power cord 19 terminated in a standard 120 volt wall plug 20 is connected to the device circuitry (not shown), preferably through the left side of handle 2 . Referring to FIG. 3 is an external right-side perspective view of the device of FIG. 1 is presented. This view shows basic air delivery section 1 b with primary air exit 4 and secondary air exits 3 attached via bayonet type joint 12 to heating element section 1 a . Dial 9 a for setting the timer is preferably located on the outside of the right rear of heating/cooling element section 1 a. Referring to FIG. 4 , an external right-side perspective view of the device of FIG. 1 is presented. This view shows child's stuffed toy air delivery section 1 c attached to heating element section 1 a . Stuffed toy air delivery section 1 c consists of a flexible, heat-resistant tube 26 inside thermal mass covering 23 . This assembly is then mounted inside a stuffed animal, toy or other object and terminates in primary air exit 4 at the toy's mouth or object's front opening and secondary air exits 3 at the toy's head or front of the object which preferably direct air rearward or to the sides. Bayonet type joint 12 locks the two sections 1 a , 1 c together. Dial 9 a for setting the timer is preferably located on the outside of the right rear of heating element section 1 a. Examples of preferred objects include varieties of toys or stylized figurines other than animals such as cars, airplanes, boats, robots or unique cartoon characters. Preferably, these embodiments are constructed in a similar manner to the animal objects disclosed herein, e.g., with a layer of thermal mass material to retain heat. These embodiments are, in effect, functional stuffed toys, in that that they can be left on top of the bed with other conventional stuffed animals or toys. At bedtime, the object is simply attached for a short period of time to heating element section 1 a to warm the bed and charge the object with heat. Then, the object is left in the bed for the child to sleep with. Varieties of these embodiments may be designed to meet the needs of slightly older children. These embodiments preferably include objects in the form of another type of soft toy, such a rocket ship, car, airplane, cartoon character, etc. or objects that are not considered toys, e.g., novelty items like a stuffed flower bouquet or a small stylized pillow. Other examples of preferred objects include small firm pillows such as cylindrical or oval bolster pillows that may be covered with decorative prints and/or soft textured fabric like flannel cotton or acrylic pile. These embodiments are also preferably in a similar manner to the animal objects disclosed herein, e.g., with a layer of thermal mass material (e.g., gel pac) to retain heat. These embodiments preferably have semi flexible air channels running parallel to the longitudinal axis of the object, perhaps with a series of auxiliary tortuous air channels to facilitate thermal mass charging. The bayonet mount air entry opening and opposing air exit opening are preferably flush with the pillow ends such that they are not readily differentiated from the main body of the pillow. These embodiments can be left on top of the made bed as or with other decorative pillows. The object functions in a similar fashion to the stuffed toys and gel pac, i.e., at bedtime, it is attached to heating element section 1 a which simultaneously warms the bed and charges the object with heat. The object is then be detached and used in the bed to be placed under the neck, lower back, etc. to provide comfort and relaxation to specific body areas. Referring to FIG. 5 , a right side perspective view of the device of FIG. 2 is presented. This view shows an exterior view of heating element section 1 aa detached from thermal gel air delivery section 1 d and basic air delivery section 1 b . The different air delivery sections are thus easily interchangeable via bayonet type joint 12 , which utilizes lugs 13 to engage receptacles in air delivery sections 1 b , 1 d that lock heating element section 1 aa to air delivery section 1 b or air delivery section 1 d. Referring to FIG. 6 , a right side perspective view of the device of FIG. 1 is presented, showing an exterior view of heating element section 1 a detached from child's toy air delivery section 1 c and basic air delivery section 1 b . The different air delivery sections are thus easily interchangeable via bayonet type joint 12 , which utilizes lugs 13 to engage receptacles in the air delivery sections that lock the heating element and air delivery sections together. Referring to FIG. 7 , a 3D rendering of a preferred embodiment of the device of FIG. 1 is presented. This view shows a camera/perspective view in FIG. 7A , a top view in FIG. 7B , a side view in FIG. 7C , a front view in FIG. 7D and a back view in FIG. 7E . In FIG. 7C , air conditioning section 1 a is shown to be U-shaped and to be adapted to receive the edge of a cover between its lower body portion 1 a and its upper handle portion 2 . In this configuration, the blanket is prevented from covering air intake 5 during operation of the device. Referring to FIG. 8 , a 3D view of the device in use is presented. In use, the device is plugged into an electrical receptacle and placed under the undisturbed covers or blankets on a bed, either from the front of the bed facing the foot, from the side, or from the foot facing forward. In this instance, the device is placed in a bed on top of bottom sheet 30 so that the edge of cover 32 fits in slot 34 . The device is positioned such that the entire main body 1 a and 1 b of the device is under the covers or blankets 32 , resting on top of the bottom sheet or bed linen 30 , with the handle 2 on top of the covers or blankets 32 . In this way, the handle acts not only as a means of easily manipulating and positioning the device, but also as a catch that helps to hold the unit in place and that prevents the covers from falling over rear air intake 5 and blocking the flow of air. The device is then activated and left to complete an automatic run cycle of 1 to 5 minutes by setting the timer dial 9 a . If further heating or cooling is desired, timer dial 9 a may be re-set such that the device re-activates and operates for additional cycles. Preferably, air delivery section 1 b is sufficiently elongated that air discharged by the device inflates the bedding before escaping. A preferred embodiment of heating element section 1 a utilizes a heating coil to heat the air passing through it. This version is used during the cold months of the year for warming a bed. Another preferred embodiment of heating/cooling section 1 aa contains thermoelectric module 15 that utilizes the Peltier effect to either heat or cool air passing through the device. It is used at any time during the seasonal cycles to either warm or cool a bed as desired. To this end, the heating/cooling embodiment of the invention can be easily switched from heating to cooling via polarity switch 21 . Peltier effect elements are well known in the art as disclosed in U.S. Pat. No. 4,777,802, the disclosure of which patent is incorporated by reference as if fully set forth herein. Either embodiment of the invention may be used interchangeably with different air delivery sections. FIG. 3 shows basic air delivery section 1 b that is designed for general use that is suitable for a variety of beds. FIG. 2 shows thermal gel air delivery section 1 d , which is designed as a thermal mass to absorb and retain the temperature of the air passing through the tortuous channels within it. After deactivation of the device, thermal gel air delivery section 1 d may be detached and placed anywhere in the bed or against the resting body to provide additional passive radiant and direct contact heating or cooling. FIG. 4 shows a child's version of an air delivery section created in the form of a stuffed toy dragon 1 c . A variety of toy sections may be created using elongated creatures like snakes or alligators that will work in the same manner as the dragon toy depicted. The materials comprising the exterior of the toy air delivery section 1 c are soft and flexible and able to be easily deformed. The interior is comprised of a length of semi-rigid heat resistant tubing that may slightly deform but not collapse. This tubing therefore maintains an unrestricted air channel that conducts the flow of air from the connection point to the primary air exit 4 and secondary air exits 3 . The tubing is covered in a layer of thermal mass gel, allowing toy air delivery section 1 c to retain heat or cold from the conditioned air that passes through it. After the bed has been initially warmed or cooled, child's stuffed toy air delivery section 1 c can be detached from heating/cooling element section 1 a and left with the child to cuddle with, providing an additional level of comfort as a further aid to sound sleep. Referring to FIG. 9 , a right side perspective view of another preferred embodiment of the device is presented. This figure shows an exterior view of heating element section 1 a detached from herbal infuser air delivery section 1 e . Herbal infuser enclosure door 36 is located on the top of the air delivery section and is shown in the closed position with the size and position of internal enclosure 35 indicated by dotted lines. Heating element section 1 a is also shown with the size and position of digital timer unit 40 indicated by dotted lines. Exterior pushbuttons 39 are used for setting the activation time for the device and the number of minutes the device remains in operation. LCD panel 41 displays the activation time and associated numeric timer information. Referring to FIG. 10 , a right side perspective view of herbal infuser air delivery section 1 e is presented, showing a cutaway view of its interior structure wherein the perforated herbal infuser enclosure 35 is illustrated. Infuser enclosure cover 36 is shown in the open position, allowing shaped herbal packet 38 to be placed in the enclosure basket. Enclosure door 36 is then snapped closed and the device operated in the manner heretofore described. Heated air passing through herbal infuser air delivery section 1 e passes over and warms herbal packet 38 by virtue of numerous enclosure perforations 37 , thereby infusing the aromatic herbal scent and influence into the bed. Different varieties of aromatic herbal packets may thus be used and fresh packets easily installed as often as desired. Alternatively, aromatic packets that are not derived from herbs may be used. A person skilled in the art would understand that any aromatic substance may be held in the stream of warm air moving through the device and incorporated into that stream of warm air. Many variations of the invention will occur to those skilled in the art. Some variations include heat/cold storage. Other variations call for a toy-shaped air delivery section. Still other variations call for an aromatic infuser air delivery section. All such variations are intended to be within the scope and spirit of the invention.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This is a continuation-in-part patent application of co-pending U.S. patent application Ser. No. 10/679,888, filed Oct. 6, 2003, which claims the benefit of U.S. Provisional Application Nos. 60/416,406, 60/416,407, 60/416,408, and 60/416,409, each of which was filed on Oct. 7, 2002. The contents of these applications are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] The present invention generally relates to the field of implantable medical devices for monitoring physiological parameters. More particularly, the invention relates to a system and delivery method for monitoring cardiovascular pressures using an implantable pressure sensor, such as for monitoring the progression and treatment of congestive heart failure, congenital heart disease, pulmonary hypertension, and other conditions of the cardiovascular system. [0003] Various conditions of the cardiovascular system can be diagnosed and monitored by sensing pressures within the heart and coronary arteries. A particularly complex example is a type of congenital heart disease (CHD) in which the heart consists of only one functional ventricle. In order to provide such patients with appropriate solutions, multiple surgical procedures are required to enable the single ventricle to serve as the systemic ventricle, while the lungs receive blood flow via different anastomosis (Fontan Baffle). A key dilemma in the treatment of these patients is the timing of the different surgical stages. The inclination is to perform the surgeries at a younger age. However, if performed too early, the outcome is dismal. Currently, the only way to assess the hemodynamic status is by invasive cardiac catheterization, requiring admission of the patient to a catheterization lab. Pulmonary artery (PA) pressure and resistance are currently used to decide the timing of the different surgical stages. [0004] Another condition diagnosed and monitored by evaluating PA pressure is primary pulmonary hypertension (PPH). In addition to direct invasive measurement using a catheterization procedure, Doppler echocardiography has been used as a method for evaluating pulmonary hypertension, though it too requires specialized equipment in a dedicated laboratory. The course of patients with PPH is usually long and chronic, and many treatment modalities have been proposed but none to date provide an absolute solution. Therefore, following diagnosis of pulmonary hypertension, it would be preferable to noninvasively monitor this condition on a continuing basis in order to optimize treatment. [0005] Congestive heart failure (CHF) is a condition in which a damaged or overworked heart cannot pump adequately to meet the metabolic demands of the body and/or can do so only with an elevated ventricular diastolic pressure. CHF is a major health problem worldwide, affecting millions of patients and accounts for numerous hospitalizations. Overall, the cost of treating CHF is very high (billions of dollars annually) and involves numerous physician visits. From 1979 to 1999, CHF deaths increased 145% and hospital discharges increased 155%. Survival is poor with 20% dying within one year and only 50% of patients surviving more than five years. The many patients suffering from this progressive, fatal disease tend to have an extremely poor quality of life and become increasingly unable to perform routine daily tasks. [0006] Left ventricular (LV) filling pressure is a key factor in the progression of CHF. LV filling pressure represents the diastolic pressure at which the left atrium (LA) and left ventricle (LV) equilibrate, at which time the LV fills with blood from the LA. As the heart ages, cardiac tissue becomes less compliant, causing the LV filling pressure to increase. This means that higher pressures are required from the LA in order to fill the LV. The heart must compensate for this to maintain adequate cardiac output (CO). However, increasing the LA pressure strains the heart and over time irreversible alteration will occur. [0007] Left ventricular end diastolic pressure (LVEDP) and mean left atrium pressure (MLAP) are the primary factors physicians use to evaluate CHF patients. MLAP and LVEDP (plotted in FIG. 1 ) correspond directly with LV filling pressure and are easy for physicians to identify from LV pressure data. The physician's ultimate goal is to increase cardiac output (CO) while reducing LVEDP. Treatment methods include medications, lifestyle changes, pacemakers, and/or surgery. [0008] As with the above-noted CHD and PPH conditions, the only current method for evaluating intracardiac pressures such as MLAP and LVEDP is an invasive cardiac catheterization procedure. In certain cases, CHF is complicated by mitral stenosis, necessitating significantly more precise and continuous pressure data. Atrial fibrillation can develop as a result of this condition, and the evaluation of such cases is considerably more complex since pressure gradients across the mitral valve must also be measured. Diagnosis of LV failure and mitral stenosis can be obtained by measuring the pulmonary capillary wedge pressure (PCWP), which provides an indirect measurement of MLAP. The current procedure for measuring PCWP is to advance a balloon-tipped multi-lumen (e.g., Swan-Ganz) catheter through the right atrium (RA) and right ventricle (RV) until the distal tip of the catheter is located within a branch of the pulmonary artery. The balloon is then inflated to occlude the pulmonary artery branch, and a pressure transducer distal of the balloon measures the pressure within the pulmonary artery branch, which drops as a result of the occlusion and stabilizes at a pressure level approximately equal to MLAP. [0009] As with the monitoring of pulmonary hypertension, Doppler echocardiography can be used to evaluate CHF complicated by mitral stenosis, though again with the disadvantages of requiring a specialized laboratory, specialized equipment, and the inability to perform continuous measurements. [0010] In view of the above, it can be appreciated that the treatment of cardiovascular diseases such as CHD, CHF, and pulmonary hypertension could be greatly improved through the capability of continuous or at least intermittent monitoring of various pressures and/or flows in the heart and associated vasculature. Porat (U.S. Pat. No. 6,277,078), Eigler et al. (U.S. Pat. No. 6,328,699), and Carney (U.S. Pat. No. 5,368,040) teach different modes of monitoring heart performance using wireless implantable sensors. In every case, however, what is described is a general scheme of monitoring the heart. The existence of a method to construct a sensor with sufficient size, long-term fidelity, stability, telemetry range, and biocompatibility is noticeably absent in each case, being instead simply assumed. Eigler et al. generally discuss a specific device structure but not the baseline and sensitivity drift issues that must be addressed in any long-term implant. Applications for wireless sensors located in a stent (e.g., U.S. Pat. No. 6,053,873 by Govari) have also been taught, although little acknowledgment is made of the difficulty in fabricating a pressure sensor with telemetry means sufficiently small to be incorporated into a stent. [0011] From the foregoing, it can be appreciated that the current clinical methods for evaluating intracardiac pressures, including those associated with CHF, CHD, and pulmonary hypertension, involve catheterization procedures. In addition to requiring admission of the patient to a catheterization lab, such procedures provide only a snapshot of pressure data, carry morbidity and mortality risks, and are expensive. Therefore, for the diagnosis and monitoring of the progression and treatment of cardiovascular conditions such as CHF, CHD, and pulmonary hypertension, it would be preferable to noninvasively monitor these conditions on a continuing basis to more accurately assess the patient's condition and optimize treatment. BRIEF SUMMARY OF THE INVENTION [0012] The invention comprises a method and system for noninvasively monitoring cardiac physiologic parameters used to evaluate patients with a cardiovascular condition. The system includes an implantable sensing device that is preferably batteryless and wireless, is configured to be chronically implanted in any of several cavities in the cardiovascular system, such as the heart, pulmonary artery (PA), etc. [0013] The method of this invention involves delivering the sensing device to a first cardiovascular cavity of a human patient for sensing at least one pressure within the cardiovascular system. The method entails placing the sensing device in a second cardiovascular cavity having a larger diameter than the first cardiovascular cavity, and thereafter allowing blood flow through the cardiovascular system to deliver the sensing device to the first cardiovascular cavity. According to the method, the sensing device is sized and configured so as to secure itself within the first cardiovascular cavity as the sensing device moves therethrough, and to be oriented once secured to sense a pressure within the first cardiovascular cavity. [0014] A system of this invention generally entails the sensing device sized and configured for securing itself within the first cardiovascular cavity as the sensing device moves therethrough, and a device or apparatus for placing the sensing device in the second cardiovascular cavity so that blood flow through the cardiovascular system delivers the sensing device to the first cardiovascular cavity, after which the size and configuration of the sensing device enable the sensing device to secure itself within the first cardiovascular cavity as the sensing device moves therethrough and orient itself when secured to sense a pressure within the first cardiovascular cavity. [0015] In view of the above, the sensing device of this invention is intentionally sized and configured to be released in the cardiovascular system and travel with blood flow to its intended destination, though it should be understood that the sensing device can also be delivered by such other modes as percutaneously, surgically, or on a stent. In a preferred embodiment of the invention, once in place the sensing device may be wirelessly interrogated with a reader unit that is not within the first cardiovascular cavity, and is preferably outside the patient's body. In this manner, the sensing device is capable of measuring and transmitting, in real time, any of various physiologic parameters including RV, RA, PA, PCWP, and other pressures within the cardiovascular system. The sensing device and its delivery method are particularly well suited for noninvasively monitoring congestive heart failure (CHF), the change in cardiac physiological parameters of persons with congenital heart disease (CHD), and the response of pulmonary artery hypertension (PPH) to different treatments. In particular, the delivery method of this invention is capable of placing the sensing device in, for example, a branch of the pulmonary artery to measure PCWP or PA pressure for the purpose of monitoring the progression and treatment of CHF, PPH, CHD and other diseases affecting the left ventricle, mitral valve, etc. [0016] The delivery method is also capable of placing the sensing device in such locations as the left ventricle or left atrium to measure LVEDP or MLAP for the purpose of monitoring CHF. Delivery to locations that are not blood vessels requires that the sensing device be equipped with means for securing the device locally, as has been described elsewhere including anchoring means and methods taught in commonly-assigned U.S. patent application Ser. No. 10/898,053, as well as techniques commonly used for commercial medical implants such as stents and atrial septum plugs. Other data useful to a physician and measurable with the invention (in conjunction with appropriate mathematical algorithms) include, but are not limited to, dp/dt (pressure change over time) of the LV pressure, dp/dt of the LA pressure, dp/dt of the RV pressure, RVEDP (right ventricular end diastolic pressure), and mean RA pressure. Each of these may be measured and/or derived from pressures measured in the appropriate heart cavities. For cases of CHF with mitral valve stenosis, a second implant can be placed such that mitral valve gradient can be assessed, for example, with an implant in the left ventricle (to measure LV pressure) and a second implant in the left atrium (to measure LA pressure) or the pulmonary artery (to measure PCWP). [0017] Monitoring cardiovascular system pressures in accordance with the present invention can provide a physician with one or more of the following advantages: earlier intervention in the course of disease; better tailoring of medications or other treatments and therapies to reduce pulmonary hypertension; identification of other complications from treatments or disease progression; faster feedback on the impact of medications and/or pacing changes on heart function; pacemaker parameter tuning; lower overall treatment costs; and decreased frequency and/or severity of hospitalization for pulmonary-hypertension-related conditions through improved outpatient and home care. [0018] Other objects and advantages of this invention will be better appreciated from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS [0019] FIG. 1 is a graph of typical waveforms for various pressure points within the heart. [0020] FIG. 2 is a schematic of an implantable pressure monitor anchored in a side artery of the pulmonary artery. [0021] FIG. 3 is a block diagram of a magnetic telemetry based physiologic monitoring system based on a resonant scheme according to a preferred embodiment of the present invention. [0022] FIG. 4 is a block diagram of a magnetic telemetry based physiologic monitoring system based on a passive scheme according to an alternate embodiment of the present invention. [0023] FIGS. 5 through 8 schematically represent a sensor implant and four methods for delivering the implant in accordance with different embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0024] In order to provide for the effective monitoring, management, and tailoring of treatments for conditions of the cardiovascular system, including CHD, CHF, pulmonary hypertension, etc., the present invention provides a sensing system and techniques for delivering an implantable pressure monitor of the system to a location where sensing of a pressure of interest can occur. The implantable pressure monitor is in the form of an implant 10 capable of securely anchoring itself within an artery or vein adjacent the heart, as represented in FIG. 2 . The implant 10 may be physically realized with a combination of any of several technologies, including those using microfabrication technology such as Microelectromechanical Systems (MEMS). For example, capacitive and piezoresistive pressure sensors have been fabricated with MEMS technology. The implant 10 may be in the form of a hermetic package of anodically bonded layers of glass and silicon (doped or undoped). A particularly preferred implant 10 is disclosed in commonly-assigned U.S. patent application Ser. No. 10/054,331 to Rich et al., whose contents relating to the design of such an implant are incorporated herein by reference. According to Rich et al, a suitable implant 10 has a biocompatible monolithic structure comprising a transducer integrally microfabricated in a substrate and active circuitry electrically connected to the transducer through conductive paths on the substrate. The exterior of the implant 10 can be defined by an outer shell that houses the microfabricated components of the implant 10 , with the transducer being exposed at one end of the implant 10 so as to be exposed to the pressure within the environment of the implant 10 . [0025] As will be discussed in further detail below, the implant 10 of this invention is particularly intended to be suitable for placement and sensing PCWP (pulmonary capillary wedge pressure) and PA (pulmonary artery) pressure. According to a preferred aspect of the invention, placement of the implant 10 is accomplished by releasing the implant 10 within the cardiovascular system so that the implant 10 implants itself within a cardiovascular cavity whose cross-sectional diameter is less than that of the implant 10 . Notable examples of such cavities include the pulmonary artery, pulmonary veins, and their tributaries. [0026] The implant 10 is preferably used in combination with an external reader unit, examples of which are represented in FIGS. 3 and 4 . In the preferred embodiments, the reader unit both transmits power to and receives transmitted data from the implant 10 through a wireless telemetry link. According to a preferred aspect of the invention, in addition to pressure, data transmitted from the implant 10 may include temperature, calibration data, identification data, fluid flow rate, chemical concentration, and/or other physiologic parameters. The reader unit may include a barometric pressure sensor in order to compensate for variation in atmospheric pressure. [0027] The telemetry link between the implant 10 and the reader unit is preferably batteryless, wireless, and implemented using either a resonant or passive, magnetically coupled scheme. A resonant implant 10 (shown in FIG. 3 ) is the simplest approach, and consists only of a packaged inductor coil 103 and capacitive pressure sensor 102 . Together, the sensor 102 and coil 103 form a circuit that has a specific resonant frequency. At that resonant frequency, the circuit presents a measurable change in magnetically coupled impedance load to an external coil 105 associated with an external reader unit 104 . Because the resonant frequency is a function of the inductance of the coil 103 and the capacitance of the sensor 102 , as pressure changes the resonant frequency changes as well. The external reader unit 104 is able to determine pressure by monitoring the frequency at which the coil antenna 105 impedance changes. [0028] The preferred communication scheme for the present invention, shown in FIG. 4 as being between a passive implant 10 and an external reader unit 202 , is based on magnetic telemetry. Devices that have onboard circuitry but still receive their operating power from an external source (i.e., are batteryless) are referred to herein as passive. Without the external reader unit 202 present, the implant 10 lays passive and without any internal means to power itself. When a pressure reading is desired, the reader unit 202 is brought into a suitable range to the implant 10 . In this case the external reader unit 202 uses an alternating magnetic field to induce a voltage in the implant 10 . When sufficient voltage has been induced in the implant 10 , a rectification circuit 203 converts the alternating voltage on the receiver coil 204 into a direct voltage that can be used by electronic circuitry 205 on the implant 10 as a power supply for signal conversion and communication. At this point the implant 10 can be considered alert and, in the preferred embodiment, also ready for commands from the reader unit 202 . The maximum achievable communication range is mostly limited by the magnetic field strength necessary to turn the implant 10 on. This telemetry scheme has been proven and used extensively in the identification and tracking industry (e.g., implantable RF ID technology from Texas Instruments or Digital Angel) with a great deal of acceptance and success. [0029] Once the direct voltage in the implant 10 has been established for the circuit operation, a number of techniques may be used to convert the output of the implant 10 into a form suitable for transmission back to the reader unit 202 . In the preferred embodiment, a capacitive pressure sensor 206 and sigma delta conversion or capacitance to frequency conversion of the sensor output may be easily used. Capacitive sensors are preferred due to the small power requirements for electronics when reading capacitance values. Many pressure sensors are based on piezoresistive effects and, while suitable for some applications, do suffer in this application due to the higher power levels needed for readout. Sigma delta converters are preferred due to the tolerance of noisy supply voltages and manufacturing variations. [0030] As those skilled in magnetic telemetry are aware, a number of modulation schemes are available for transmitting data via magnetic coupling. The preferred schemes include but are not limited to amplitude modulation, frequency modulation, frequency shift keying, phase shift keying, and also spread spectrum techniques. The preferred modulation scheme may be determined by the specifications of an individual application, and is not intended to be limited under this invention. [0031] In addition to the many available modulation techniques, there are many technologies developed that allow the implant 10 to communicate back to the reader unit 202 the signal containing pressure information. It is understood that the reader unit 202 may transmit either a continuous level of RF power to supply the needed energy for the implant 10 , or it may pulse the power allowing temporary storage in a battery or capacitor device (not shown) within the implant 10 . Similarly, the implant 10 of FIG. 3 may signal back to the reader unit 202 at any interval in time, delayed or instantaneous, during reader RF (Radio Frequency) transmission or alternately in the absence of reader transmission. The implant 10 may include a single coil antenna 204 for both reception and transmission, or it may include two antennas 204 and 221 , one each for transmission and reception, respectively. There are many techniques for construction of the reader coil 21 9 and processing electronics known to those skilled in the art. The reader unit 202 may interface to a display, computer, or other data logging devices 220 . [0032] A large number of possible geometries and structures are available for the coil 204 and are known to those skilled in the art. The coil conductor may be wound around a ferrite core to enhance magnetic properties, deposited on a flat rigid or flexible substrate, and formed into a long/skinny or short/wide cylindrical solenoid. The conductor is preferably made at least in part with a metal of high conductivity such as copper, silver, gold. The coil 204 may alternately be fabricated on the same substrate as the pressure sensor 102 / 206 . Methods of fabrication of coils on the sensor substrate include but not limited to one or more or any combination of the following techniques: sputtering, electroplating, lift-off, screen printing, and/or other suitable methods known to those skilled in the art. [0033] The rectification circuitry 203 outputs a constant voltage level for the other electronics from an alternating voltage input. Efficient realizations of such circuitry are standard electronic techniques and may include either full bridge diode rectifiers or half-bridge diode rectifiers in the preferred embodiment. This rectification circuitry may include a capacitor for transient energy storage to reduce the noise ripple on the output supply voltage. This circuitry may be implemented on the same integrated circuit die with other electronics. [0034] As represented in FIG. 4 , in addition to the coil antenna 204 and rectification circuitry 203 , the electronic circuitry 205 can further include signal conditioning circuitry 211 and signal transmission circuitry 212 . The signal conditioning circuit 211 processes an output signal from the sensor 206 and prepares it for transmission to an external receiving and/or analyzing device. For example, many pressure sensors output a capacitance signal that may be digitized for radio frequency (RF) transmission. Accordingly, the signal conditioning circuit 211 places the output signal of the implant 10 into an appropriate form. Many different signal conditioning circuits are known to those skilled in the art. Capacitance to frequency conversion, sigma delta or other analog to digital conversion techniques are all possible conditioning circuits that may be used in a preferred embodiment. [0035] The signal transmission circuitry 212 transmits the encoded signal from the signal conditioning circuitry 211 for reception by the external reader unit 202 . Magnetic telemetry is again used for this communication, as the transmission circuitry 212 generates an alternating electromagnetic field that propagates to the reader unit 202 . Either the same coil 204 is used for signal reception and for transmission, or alternatively the second coil 221 is dedicated for transmission only. [0036] A third option, particularly useful for (but not limited to) situations in which long-term data acquisition without continuous use of a reader unit is desirable, is to implement the implant 10 using an active scheme. This approach incorporates an additional capacitor, battery, rechargeable battery, or other power-storage element that allows the implant to function without requiring the immediate presence of the reader unit as a power supply. Data may be stored in the implant 10 and downloaded intermittently using the reader unit as required. [0037] In addition to the basic implant-and-reader system, a number of other embodiments of the technology can be realized to achieve additional functionality. The system may be implemented as a remote monitoring configuration, including but not limited to home monitoring, which may include but not limited to telephone based, wireless communication based, or web-based (or other communication means) delivery of information received from the implant by the reader unit to a physician or caregiver. [0038] A closed-loop drug delivery system may also be envisioned. Data from the implant 10 can be fed directly to a drug delivery device (which may or may not be implanted, and may or may not be an integral part of the implant 10 ). This approach would allow continuous adjustment of medications for pulmonary-hypertension-related conditions with minimal physician intervention. [0039] Implanted sensor data may be used as feedback for a RA-LA unidirectional valve, in either an open-loop or closed-loop configuration, which can be used to treat pulmonary hypertension in at-risk patients. For example, the valve could be modulated to maintain a mean RA-LA pressure of less than 10 mmHg. Pulmonary decompression is accomplished by allowing some blood to flow directly between the RA and LA, thus reducing the PA pressure. [0040] In addition to sensing pressure, the implant 10 can be any suitable miniature sensor adapted to detect and/or monitor various physiological parameters. For example, such a sensor may be a temperature, flow, velocity, impedance, or vibration sensor, or a sensor adapted to measure specific chemistries such as blood or chemical composition, chemical concentration, gas content (e.g., O 2 and CO 2 ), and glucose levels. Various specific examples of these types of miniature sensors are known to those skilled in the art, and any one or more of these suitable sensors can be utilized in the implant 10 of the present invention. In addition to sensing physiologic parameters, the described implant 10 could be augmented with various actuation functions. In such case, the implant 10 would be augmented with any of various actuators, including but not limited to: thermal generators; voltage or current sources, probes, or electrodes; drug delivery pumps, valves, or meters; microtools for localized surgical procedures; radiation-emitting sources; defibrillators; muscle stimulators; pacing stimulators, left ventricular assisting device (LVAD). While the specific functionalities of the implant 10 chosen will depend on the application, the size and shape of the implant 10 must be suitable for placement, delivery, and implantation of the implant 10 , as discussed below. [0041] The implant may be located in various places within the cardiovascular system, depending on the blood pressure measurement of interest. Because the number of implants 10 is not practically limited by the technology, multiple locations for blood pressure and/or other physiologic parameter measurements are easily established, including all chambers of the heart, major arteries and appendages. [0042] As represented in FIG. 2 , the implant 10 is particularly well suited for placement in the pulmonary artery. As depicted in FIG. 2 , the implant 10 has a diameter (e.g., less than 5 mm) less than that of the branch of the pulmonary artery in which the implant 10 is intended to be placed, and the implant 10 is released within a larger branch of the pulmonary artery for delivery by blood flow to the desired branch. It will be understood that blood flow will continue to push the implant 10 through any number of pulmonary artery branches with diameters smaller than the diameter of the larger artery used for the injection, until the implant 10 enters a pulmonary artery that is small enough to prevent further progress of the implant 10 , at which point the implant 10 becomes wedged or anchored in the pulmonary artery. With this approach, the artery in which the implant 10 has lodged (secured) itself is likely and, for measuring PCWP, preferably occluded, though it should be understood that there are many more pulmonary arteries that will compensate for the blocked artery. As represented in FIG. 2 , a suitable exterior shape for the implant 10 to promote a proper orientation of the implant 10 and occlusion of an artery is a cylindrical shape, with the length of the implant 10 preferably being greater than its diameter in order to inhibit migration and pitching (flipping) of the implant 10 . While the physical shape and size of the implant 10 can be relied on to secure the implant 10 within the artery, such that the implant 10 does not require a discrete anchoring appendage, cell growth and encapsulation will happen over time, leading to further stabilization of the implant 10 . As such, the pressure sensor is positioned in the implant 10 to sense the pressure of interest while there is a layer of cell growth on the implant 10 . [0043] Several catheter delivery methods are envisioned for delivering the implant 10 for the purpose of monitoring cardiovascular conditions, including CHF, CHD, PPH, etc., particularly in combination with a remote unit (e.g., the aforementioned reader units 104 and 202 ) capable of wirelessly communicating and telepowering the implant 10 as described above. In each case, the implant 10 lacks a discrete anchor and no post delivery sutures are used, though it will be appreciated that both anchors and micro-surgical techniques well-known to catheter users, both clinical and research, could be employed for delivery of the implant 10 . [0044] According to the invention, a wide variety of catheter styles can be employed, including styles commercially available, commercially available but modified by the user, and custom designs such as those described below and within the capability of one of ordinary skill in the art. Particular catheter styles that can be used include commercially available articulated (or positionable) catheters, standard catheters, and sterilizable tubing (both shrink tubing and non-shrink tubing) used alone or in combination with guidewires and ancillary catheter implements (introducers, sheaths, side ports, Luer lock fluidic ports, etc.) The catheter can be formed of a variety of materials, while its size can be extended to any size used in a relevant clinical procedure, such as between 11 Fr and 14 Fr. In preferred embodiments of the invention, the distal tip of the catheter is modified to temporarily secure the implant 10 . For example, the implant 10 can be directly secured to the catheter tip, secured to a length of tubing (shrink or non-shrink) attached (e.g., adhesively or shrink-fit) to catheter tip, or secured by a fixture with lumen affixed to the tip, and then released therefrom using, for example, a hydraulic pulse, tether, ball-style, bearing-style, or collet-style joint, fusible link, Acme magnet, etc. The modification to the catheter tip can provide a variety of functions, including additional degrees of freedom (i.e., rotation at a joint, bending at a joint, etc.). Any modification, fixture, or holder with which the catheter is equipped can be machined, molded, cut from stock, or formed from a wide variety of materials, including but not limited to PEEK™, TEFLON®, polyolefin, PVC shrink tubing, other machinable and formable plastics, metals, etc. Such modifications, fixtures, and holders can be assembled and attached using a wide variety of materials and methods, including but not limited to adhesives, epoxies, solvents, heat, welding, interference fit (friction), hydraulic forces (vacuums), etc. With each approach, the modification of the catheter is intended to allow attachment of the implant 10 to the catheter, provide a means for releasing the implant 10 from the catheter, and provide both control and flexibility of the catheter tip to allow maneuverability through the arteries, veins, and heart. [0045] Suitable catheterization procedures carried out with this invention are similar to standard cardiac and pulmonary artery catheterization procedures that, as will be understood by those familiar with clinical and research catheterization procedures, can involve anywhere from a single insertion to many insertions of various catheter tools, such as sheaths, introducers, guidewires, incision and suturing tools, microsurgery and imaging tools, and so on. During the catheterization procedure, the catheter, its distal tip, and any catheter tools can be tracked with external standard imaging tools such as a fluoroscope. All such equipment is preferably sterilizable by standard clinical and research methods, a preferred example of which is gas mediated sterilization such as but not limited to EtO (ethylene oxide) gas sterilization. It is believed that sterilization soaks could also be used, an example of which is solutions containing glutaric dialdehyde (C 5 H 8 O 2 ), such as CIDEX®. [0046] In FIG. 5 , a catheter 12 is shown whose distal tip 14 is sized to receive an annular rim 16 formed at one end of an implant 10 , and to secure the implant 10 with an adhesive or an interference fit with an annular rim 16 defined by a delivery sleeve. In this embodiment, the rim 16 is pressed over the tip 1 4 of the catheter 12 where it is held until forcibly displaced from the catheter 12 , such as by a hydraulic pulse delivered through the catheter 12 with a suitable fluid, which can be any sterilized fluid commonly used in catheterization and surgical procedures, including but not limited to 0.9% saline, Ringer's solution, and electrolyte replacement solutions. [0047] FIG. 6 represents another embodiment in which the implant 10 is configured to have a tether attachment 26 at one end thereof. The catheter 22 is equipped with a tether 28 looped through the attachment 26 to secure the implant 10 , with both ends (not shown) of the tether 28 exiting the manipulator (external) portion of the catheter 22 to permit the operator to selectively release the implant 10 from the distal tip 24 of the catheter 22 . [0048] FIG. 7 represents yet another embodiment that employs a collet-style joint for releasably securing the implant 10 . The implant 10 formed to have a ball end 36 gripped by multiple spring-loaded collet fingers 38 formed at the end of a collet tube 34 and extending from the distal end of the catheter 32 . By retracting the catheter 32 relative to the collet tube 34 , the fingers 38 are allowed to resiliently expand and release the implant 10 . By gripping the implant 10 in the manner shown, rotation of the collet tube 34 and its fingers 38 allows for angular movement of the implant 10 relative to the catheter 32 . [0049] FIG. 8 represents an embodiment similar to that of FIG. 7 , but with a catheter 42 provided with a tube 44 equipped with latch fingers 48 that extend from the distal end of the catheter 42 , and a lock catheter 50 within the tube 44 that forces the latch fingers 48 radially outward into engagement with catches 46 disposed at one end of the implant 10 . By retracting the lock catheter 50 , the fingers 48 are allowed to collapse and release the implant 10 . [0050] A corollary to the operation of releasing the implant 10 is its recovery. Recovery of the implant 10 is also application dependent, where the degree of tissue growth around the implant 10 may affect the ability to use catheter-based microsurgical tools needed to effect recovery. In addition to long term recovery, there is a need in certain applications for short term or acute recovery (as in, for example during the procedure, should repositioning of the implant 10 be indicated). For recovery, any catheter tool with a physical gripper end, either commercially available or custom made, could be potentially employed. Moreover, the implant 10 itself can be modified to include a handle to allow reattachment to, for example, a mechanical latch, ball joint, tether loop, collet, or any of other designs based on the concept of a feature handle and a means of attaching a tether or modified catheter or catheter tool in-vivo. [0051] The ability of an implant 10 as described above to implant itself in a restricted cavity of the cardiovascular system was demonstrated with a female canine. The procedure involved a pair of implants, both having diameters of about 3.7 mm and with different lengths of either 14.5 or 17.5 mm. Each implant was a completely self-contained unit similar to the implant 10 represented in FIG. 4 , and therefore equipped for wirelessly communicating and telepowering with a reader unit (similar to the aforementioned reader unit 202 ) and equipped with a capacitive pressure sensor disposed at one end of the implant for capacitively sensing pressures to which the exterior of the implant is exposed. Both implants were delivered to a large pulmonary artery with modified positionable catheters (14 Fr), which worked well though some articulation was lost due to mechanical stresses during insertion that interfered with the ability to precisely place the implants at the intended delivery sites. The shorter implant was placed for sensing wedge pressure (PCWP), while the longer implant was intended for proximal PA measurements. [0052] Aside from the modified articulated catheters, the process of insertion used standard catheterization techniques. Following sterilization of all components, each implant was individually loaded in a PEEK™ fixture adhered to the distal end of the catheter, generally similar to the embodiment of FIG. 5 . Each fixture held its implant with friction assisted by hydraulic back pressure using a saline solution that was also used to flush the catheter and eject the implants. The saline solution was dispensed with a syringe connected to a three-way Luer lock stopcock. A surgical insertion was made through the groin and each catheter was threaded up through the femoral vein, through the heart, and to the pulmonary artery main branch. At that point, the intention was to place the implants as close as possible to the best target tributary artery as determined by the surgeon on examination of the arterial bed under the fluoroscope. The shorter implant was released with a hydraulic pulse of the saline solution, and thereafter traveled several millimeters with the blood flow from the end of the pulmonary artery main branch and into a side artery with the transducer facing away from the catheter so as to be oriented for sensing PCWP. The longer implant was released in the same manner but unintentionally early, and as a result was delivered to the same site as the shorter implant. The longer implant was oriented for sensing pulmonary artery (PA), i.e., with its backside (opposite the transducer surface) touching the backside of the shorter implant. [0053] Following the catheterization procedure, the implants were detected by placing the antenna of the reader unit along the left side of the spine near the heart. Though the values of the sensed pressures were off scale (about 700 to 900 Torr absolute), suggesting other factors were influencing the transducers of the implants beyond the expected wedge/proximal PA pressures, the procedure nonetheless demonstrated the ability to deliver an implant to a branch of the pulmonary artery for the purpose of sensing PCWP and PA pressures. The implants were noted as being oriented parallel to the spine, with the result that the range of the implant signals was limited because the antenna of the reader unit could not be placed perpendicular to the ferrite coils of the implants. Nonetheless, data signals were detected and recorded for both of the implants. [0054] The initial impression of tissue response was positive, as no evidence of necrosis or infection was seen. One of the implants had a small amount of fibrous growth on the transducer end while the other exhibited almost no growth. The slight buildup of tissue did not appear to interfere with the operation of the implant. [0055] While described above in reference to self-implantation of the implant 10 in a restricted cavity of the cardiovascular system, it will be understood that the implant 10 could be adapted for placement in other cardiovascular cavities. A notable example is the atrial septum, since an implant in the atrial septum would not significantly impede blood flow and would thus minimize the thrombogenic effect of flow turbulence. For such applications, the implant 10 of this invention requires an anchor such as types known and employed with devices already used for implantation, as well as improved anchoring techniques as taught in the aforementioned U.S. patent application Ser. No. 10/898,053. Devices such as septal occluders, pacemaker leads, left atrial appendage occluders, etc., may be used as carriers for the implant 10 . Devices have been made and approved by the FDA to occlude atrial septum defects (a septal occluder) and other vascular holes. As an example, the implant 10 could be equipped with an umbrella structure that can be folded within a catheter for delivery and then expanded for implantation. An important aspect of this approach is that the majority of the implant 10 is preferably located in the right side of the heart, with minimum protrusion in the left side of the heart to reduce the thrombogenicity. To further limit the risk of thrombogenesis, preferred implants 10 of this invention are shaped and sized to have limited protrusion of volume into the blood stream. For example, the implant 10 can be formed to have a preformed or overmolded outer shell formed with existing plastic injection technologies suitable for medical implantation. An outer shell coating can be applied to provide a particularly non-thrombogenic exterior. Suitable coating materials include silicone, hydrogels, parylene, polymer, nitrides, oxides, nitric-oxide generating materials, carbides, silicides, titanium, and combinations thereof. [0056] Pacemaker leads have a well-established history for implantation methods, and similar techniques are possible for use with the implant 10 of this invention. For example, an anchoring appendage such as a screw or barb could be used to attach the implant 10 to a heart or vessel wall. Such an anchor may be molded into a shell that defines the exterior of the implant 10 , and screwed into the ventricle wall so that the screw is buried below the wall surface. In addition, the implant 10 may include a mesh to promote tissue growth and anchoring. Another option is to attach the implant 10 with a metal tine or barb placed with a catheter. Such an approach is known to work well in trabeculated areas of the heart, and has therefore been used for implanting pacing leads in the right ventricle. Clips or expanding probes may also be used, both of which would penetrate the heart or vessel wall slightly. [0057] The foregoing disclosure includes the best mode devised by the inventors for practicing the invention. It is apparent, however, that several variations in the apparatuses and methods of the present invention may be conceivable by one skilled in the art. Because the foregoing disclosure is intended to enable one skilled in the pertinent art to practice the instant invention, it should not be construed to be limited thereby, but should be construed to include such aforementioned variations. Therefore, the scope of the invention is to be limited only by the following claims.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to the filing date of U.S. Provisional Application No. 61/197,954 filed Oct. 31, 2008; the disclosure of which is herein incorporated by reference. BACKGROUND OF THE INVENTION 1. Field of the invention The invention relates to methods of using compositions for forming microbial sealant drapes. In particular, the invention relates to the use of compositions of combinations of cyanoacrylates for the in situ formation of microbial sealant drapes that can be used in surgery to protect patients from surgical site infections. 2. Description of the Prior Art Surgical site infections (SSIs) can be classified into two categories: (1) incisional and (2) organ, which includes organs and spaces manipulated during an operation. Incisional infections are further divided into superficial infections and deep soft tissue-muscle and fascia infections. The Centers for Disease Control and Prevention estimates that approximately 500,000 surgical site infections occur among an estimated 27 million surgical procedures conducted every year in the United States. Surgical site infections (SSI) are listed as the second most common cause of nosocomial infection after urinary tract infections, which accounts for 40% of hospital-acquired infections among surgical patients. Twenty five to thirty-eight percent of all nosocomial infections among surgical patients are estimated to be incisional surgical site infections. SSI is a significant cause of surgical morbidity and mortality, occurring in 2-5% of patients having clean extra-abdominal operations and up to 20% of patients undergoing intra-abdominal procedures. Patients with SSI are twice as likely to die, 60% more likely to be admitted to an Intensive Care Unit, and more than 5 times more likely to be readmitted to the hospital than patients who are not infected. Surgical site infections result in longer hospitalization and have large economic impact on patients and the health care system. Patients with surgical site infections are hospitalized an additional 7 days on average. The longer hospital stay cost an additional $3,152 on average. The average total cost for medical care during the eight weeks after hospital discharge is $5,155 for patients with surgical site infections compared with $1,773 for patients without SSIs. The total cost includes out patient visits, pharmacy, radiology services, re-hospitalization, skill-nursing facility, home health aids, and durable equipment. The frequency of surgical site infections in patients varies from surgeon to surgeon, hospital to hospital, surgical procedure to surgical procedure and patient to patient. Surgical site infections can be caused by external sources of contamination including surgical personnel, surgical environment, and surgical instruments. Most SSIs are, however, caused by patient's own normal skin flora which can enter the body through the surgical incision. The patient's skin flora is considered as the first and foremost pathogenic source because the transmission of bacteria from skin to the incision is very efficient. Innocuous bacterial flora on the skin may also be colonized by pathogenic organisms. The bacteria of normal skin flora can cause wound infection in the presence of foreign materials that greatly enhance the pathogenic potential of these bacteria. Therefore, bacterial contamination occurs predominantly during and following surgical procedures. Different methods of preventing SSIs have been developed to reduce patients' surgical site infections. Advanced surgical techniques and skillful surgeons can reduce the duration of surgery. Operation personnel and operation room hygiene management can lower the probability of exogenous pathogens. Operations that are conducted when patients have healthy physical and psychological states may enhance patients' immune system so that the chance of surgical infections may be considerably reduced. Thoughtful plans and careful selection of effective antibiotics can also help reduce the chance of contamination of bacteria. Topical bactericidally active or antimicrobial agents such as iodophors, chlorhexidine, and alcohol-containing products have been applied to the surgical site before surgery to kill bacteria. These agents are preoperative skin preparation products, washes, surgical scrub tissues, wound cleaners, lotions and ointments. As early as 1960s, the successful use of prophylactic antibiotics was reported in a randomized, prospective, placebo-controlled clinical study of abdominal operations on the gastrointestinal tract. The success of antibiotic prophylaxis was due to the appropriate patient selection and wise choice of available agents. U.S. Pat. No. 4,542,012 teaches the application of antimicrobial agents by depositing antimicrobial compositions onto human skin to form an antiseptic film. The antimicrobial composition is applied to the skin as a liquid solution in a fugitive solvent. After the solvent evaporates, a thin film containing antimicrobial agent is formed on the skin. U.S. Pat. No. 5,916,882 discloses a providone-iodine alcohol gel antimicrobial skin-preparation formulation which is used to disinfect a surgical site. The pre-operative skin-preparation formulation quickly kills bacteria when applied to the surgical site. The skin-preparation formulation continues to effectively inhibit microorganism growth in the applied area for a relatively long period of time. Application of the skin-preparation formulation is controllable because the formulation does not run when applied to a patient. The antimicrobial skin-preparation formula includes iodine, alcohol and gel. U.S. Pat. No. 6,228,354 provides a skin-preparation composition which does not harm the skin yet promotes asepsis on the skin. The skin-preparation composition disclosed has a rapid antimicrobial activity when in a liquid form and a sustained antimicrobial activity when dry. The skin preparation composition forms a water-resistant film on skin and is not readily removed when a wound or surgical site is sponged or irrigated. The antimicrobial film can be removed by rubbing an aqueous solution having the proper pH onto the skin. This patent describes a film-forming topical antimicrobial composition that includes a broad spectrum antimicrobial agent, a water-resistant polymer system, a neutralizer, a pH sensitive polymer, and an alcohol. U.S. Pat. No. 6,488,665 discloses an antimicrobial skin-preparation delivery system used to disinfect a surgical site. The antimicrobial skin-preparation formula consists of iodine, alcohol and gel. The delivery system is composed of an antimicrobial alcohol gel formulation contained within a sealed, flexible container and a gel formulation dispenser connected to the container. A porous applicator pad with enlarged holes for passage of the gel formulation is described. The flow rate of the gel formulation is controlled by the external pressure applied to the flexible container. US Patent Publication Nos. 20040126355 and 20080102053 disclose antimicrobial skin compositions comprised of an antimicrobial agent, water, an alcohol, and one or more pH sensitive viscosity builders. The composition's viscosity is from 100 cp to 1,000 cp and the formulation combines the advantages of an antimicrobial agent and an alcohol. The viscosity of the formulation permits dispensing from the applicator, while preventing the solution from flowing away from the wound area. pH sensitive methacrylic polymers are used as viscosity modifiers. The preparation forms a water-resistant film that is difficult to remove during wound irrigation, but can be easily removed upon completion of the procedure. One of the disadvantages associated with topical application of skin preparation products is that the antimicrobial agents are only effective for a short period of time. Bacteria that may have survived the initial application of skin preparation products can proliferate and produce a large pathogen population. In addition, appropriate antimicrobial prophylaxis is determined by many factors such as proper case selection, anti-microbial agent selection, dosing and route of administration and duration of therapy. Inappropriate use of antimicrobial agents not only increases the cost of medical health care, but also exposes the patient to potential toxicity and other risks. Moreover, many gram-positive organisms isolated from patients with surgical site infections are resistant to multiple antimicrobial agents. The problem of antimicrobial resistance in gram-positive nosocomial pathogens has been a growing concern. In addition to the use of antimicrobial skin preparation products, surgical incise drapes have also been used to help reduce the migration of germs and bacteria into the incision site. The surgical incise drape is usually a clear polymeric film with an adhesive backing on one side which is in turn covered with a release liner. Generally, the incise drape is used in conjunction with towels or surgical drapes to maintain the surgical site as sterile and clean as possible in order to inhibit surgical site infections. A continuous or longer lasting antimicrobial effect may be obtained by combining the antimicrobial agent with a surgical incise drape. U.S. Pat. No. 3,579,628 discloses a hydrophilic acrylic film dressing which contains a composition which reacts with water to generate a bacteriostatic substance. The hydrophilic acrylic films are particularly suitable for use as occlusive dressings and for reducing bacteria. U.S. Pat. Nos. 4,310,509 and 4,323,557 disclose dermatologically acceptable compositions made of a pressure-sensitive surgical incise drape and a broad-spectrum antimicrobial agent which can be released from the drape placed in contact with the skin. The active broad-spectrum antimicrobial agent is polyvinylpyrrolidone-iodine complex or chlorhexidine. The antimicrobial agents are applied onto the surgical drape which is made of polymeric materials such as polyurethane, polyvinyl ethers, polyesters, or polyethylene. U.S. Pat. No. 4,340,043 discloses an adhesive-coated incise drape material incorporating uniform amounts of silver sulfadiazine as an antimicrobial agent. The incise drape is made of polyurethane sheets with an adhesive layer. U.S. Pat. No. 4,643,181 discloses a surgical dressing or incise drape material comprising a substrate coated with an antimicrobial containing adhesive. The substrate may be a woven or knitted fabric, a nonwoven fabric, a plastic or a polymeric film. The preferred substrate in the invention is a polyurethane film. The antimicrobial is polyhexamethylene biguanide hydrochloride, which is distributed in the adhesive as particles with a size in the range of 20 to 300 microns. U.S. Pat. No. 5,069,907 discloses a synthetic polymeric film or fabric surgical drape having incorporated therein a broad spectrum antimicrobial agent. The drape may have an adhesive layer attached to one of its external surfaces. The preferred antimicrobial agent used is 5-chloro-2-(2,4-dichloro-phenyl)phenol. Suitable adhesives utilized include polyacrylate adhesives. U.S. Pat. No. 5,803,086 discloses adhesive coated incise drapes useful in surgical procedures. The incise drapes comprise a flexible film backed coating on one side with a dermatologically acceptable pressure sensitive adhesive (PSA) on the other side. The incise drape can be applied by two people wherein one person holds the core and a second person unrolls the drape by pulling on the handle protruding from the opposite end of the drape. U.S. Pat. Nos. 5,979,450; 5,985,395 and 6,742,522 provide surgical incise drapes comprising a flexible film having a major portion thereof coated with an adhesive. The incise drape has a leading edge and a trailing edge and further includes a film handle at the leading edge. Methods described include providing a drape, grasping the film handle of the drape, pulling upon the liner to remove at least a portion of the liner exposing at least a portion of the adhesive coating the major portion of the flexible film, holding the surgical incise drape in a position such that at least a portion of the adhesive is contacting the patient, and then removing portions of the liner remaining. US Patent Publication Nos. 20020002223, 20040115274 and 20080078413 disclose adhesive compositions containing acrylic polymers, tackifiers and a broad spectrum antimicrobial agent. The adhesive composition is an essentially solventless composition. The antimicrobial agent utilized is diiodomethyl-p-tolylsulfone with a preferred concentration of antimicrobial agents in the adhesive of about 0.1% to about 2% loading by weight. The antimicrobial adhesive composition is included in a polymeric substrate to form a surgical drape. The polymeric substrate is preferably a polyester or co-polyester sheet material. US Patent Publication No. 20050284487 discloses a draping product, which is coated with adhesive along at least one edge. The adherence strength of the adhesive is greater than 0.5 N/25 mm when applied to skin. The damage to stratum corneum of the skin covered by the adhesive is less than 30% after removal. The adhesive coating is comprised of a pressure sensitive adhesive such as silicone elastomer, a hydrogel or a soft, tacky hot melt adhesive. US Patent Publication No. 20070048356 describes an antimicrobial material composition that can be applied to material substrates. The antimicrobial composition includes a first or primary antimicrobial agent, such as polyhexamethylene biguanide (PHMB), a second antimicrobial agent, an anti-static agent or fluoropolymer and/or an organic acid. The substrate may encompass both woven and nonwoven fabrics made from either natural or synthetic fibers, rubber, plastic, and other synthetic polymer materials. The composition exhibits an effective microbe-killing efficacy within a period of about 30 minutes. In spite of the beneficial properties of conventional surgical drapes with respect to inhibition bacterial infection, there are many challenges and problems associated with the conventional surgical drapes regardless of whether they incorporate antimicrobial agents. Under certain circumstances conventional surgical drapes may actually increase the risk of surgical site infection. Conventional surgical drapes can be lifted during surgery which results in entry of bacteria into the surgical site. The lifting of the conventional surgical drape is usually caused by failure of the adhesive to remain in contact with the patient's skin. Attempts to increase adhesive strength may also prove disadvantageous because more force is then required to remove the drape from skin leading to damage of the skin near the surgical site. Conventional surgical drapes are normally large and difficult to apply to the patient without wrinkling the drape film. Wrinkling of the surgical drape at the surgical site may block visibility, making it difficult for the surgeon to see the incision site. In addition, the surgical drape will not prevent microorganisms from entering the incision if the drape is wrinkled. Wrinkling is especially problematic with application of the conventional surgical drapes to a non-flat skin surface such as the elbow or knee. Incorporation of antimicrobial agents into conventional surgical drapes may permit the antimicrobial action of the agents to last longer. Antimicrobial agents currently available are, however, not effective at killing and immobilizing pathogens on the surface to which the agents are applied. The extensive use of antimicrobial products has raised concerns about antimicrobial resistance to antibiotics. In addition, most antimicrobial compounds are heat labile and cannot survive radiation sterilization. This makes it difficult to prepare sterile surgical drapes infused with antimicrobial agents. Even though many different procedures have been applied to reduce surgical site infections, the risk of such infections still exists because of the continuing survival of skin bacteria after these treatments. Since endogenous flora on patient's skin plays a key role in the development of surgical site infections, a simple and comprehensive solution to the problem would be to minimize endogenous bacteria at and around the surgical site. It is known that cyanoacrylate polymer film can act as a mechanical barrier to penetration by bacteria while maintaining a natural healing environment. Cyanoacrylate monomers, which polymerize on contact with tissue surface to provide a thin and flexible polymer film, have been used as tissue adhesives for several decades. Cyanoacrylate adhesives also exhibit strong bond strength and very rapid cure time. Cyanoacrylate' properties as adhesives may also make them desirable candidates as microbial sealant drapes. Cyanoacrylate microbial sealant drapes could prevent surgical site infections by overcoming the difficulties experienced by the conventional surgical drapes. U.S. Pat. No. 7,255,874 discloses that modified cyanoacrylate monomers can be used in various medical applications including wound closure, treatment of burns and abrasion and as surgical drapes. U.S. Pat. No. 5,730,994 describes methods for draping a surgical site by the in situ formation of cyanoacrylate polymer drape over skin surface. While the specification describes various cyanoacrylate monomers that can be used as surgical drapes, the preferred compositions contained only n-butyl cyanoacrylate. Furthermore, only n-butyl cyanoacrylate compositions were tested as surgical drapes. There are several shortcomings associated with using n-butyl cyanoacrylate as a surgical drape. Compared to longer chain alkyl cyanoacrylates, n-butyl cyanoacrylate is less flexible and cracks more easily after forming a polymer film. Thus a plasticizer is usually needed in the n-butyl cyanoacrylate formulation to improve flexibility. In addition, short-chain cyanoacrylates polymerize quickly and then degrade rapidly into formaldehyde and the corresponding alkyl cyanoacetate, which can cause significant histotoxicity. Polymer films of n-butyl cyanoacrylate sloughs off from skin faster than that of long alkyl chain cyanoacrylates. Skin irritation also occurs with the use of n-butyl cyanoacrylate. Hence, development of a cyanoacrylate-based microbial sealant drape which can immobilize the infectious microorganisms and effectively seal out the bacteria from a surgical site is desired. It is desirable to have a cyanoacrylate-based microbial sealantdrape product that can provide a uniform and flexible film. It is also desirable to develop a cyanoacrylate microbial sealant drape with significantly less tissue toxicity. Additionally, it is also desirable to develop an easy to use cyanoacrylate-based microbial sealant drape that will last a long time after the surgery to inhibit the postoperative surgical site infections. SUMMARY OF THE INVENTION The present invention provides cyanoacrylate-based liquid microbial sealant drape compositions comprising mixtures of cyanoacrylates to inhibit the surgical site infections. The liquid sealant film formed upon polymerization of the cyanoacrylate mixture prevents the spread of bacteria by trapping and immobilizing the microorganisms on the surgical sites. The compositions of the present invention provide flexible microbial sealant drapes without the addition of plasticizers and/or antimicrobial agents. The present invention provides a method of performing surgery with a lowered risk of contamination including the steps of applying a preoperative skin preparation to a surgical site, applying the microbial sealant drape composition based on liquid cyanoacrylates to the surgical site, forming the microbial sealant film on the surgical site, making an incision through the microbial sealant film, and performing surgery. The present invention provides liquid microbial sealant drape compositions which can effectively reduce the amount of microorganisms in the surgical site. Effective immobilization of microorganisms, by liquid microbial sealants of the present invention, were confirmed by both in vitro and in vivo bacteria immobilization test. In vitro immobilization test on sterile pig skin confirms that the microbial sealant compositions of the present invention are at least 95% effective in preventing the spread of the clinically relevant bacteria on the surgical sites under a variety of usage conditions. In preferred embodiments of the microbial sealant compositions of the present invention the compositions are at least 99.5% effective in preventing the spread of the clinically relevant bacteria on the surgical sites under a variety of usage conditions. In more preferred embodiments of the microbial sealant compositions of the present invention the compositions are at least 99.9% effective in preventing the spread of the clinically relevant bacteria on the surgical sites under a variety of usage conditions. The microbial sealant compositions of the present invention do not need to be used in combination with an antimicrobial surgical incise drape and may be used as a substitute for an antimicrobial surgical incise drape. The in vivo bacteria immobilization on 60 human subjects indicates that the microbial sealant compositions of the present invention can reduce microbial colonization by at least 99.9% within 15 minutes and maintain at least a 99.9% reduction throughout the 24 hours post treatment. The present invention provides microbial sealant drape compositions which are resistant to the passage of blood-borne pathogens using viral penetration as a test system. No viral penetration was detected for the disclosed microbial sealant film. The present invention provides a method of inhibiting the surgical site infections during and post the surgery. It takes days for the microbial sealant film to slough off. The disclosed cyanoacrylate liquid drape compositions are thus providing the post-surgical infection protection based on the anti-microbial property of cyanoacrylates. The present invention provides microbial sealant drape compositions which provide a desirable degradation profile. The present invention provides microbial sealant drape compositions including at least one cyanoacrylate monomer with longer alkyl chain and at least one cyanoacrylate monomer with shorter alkyl chain. The desired cyanoacrylate properties can thus be fine-tuned by combining the longer chain and shorter chain cyanoacrylates in specific ratios. Properties such as bonding strength, setting time, viscosity, degradability and biocompatibility can be altered depending on the specific combination of cyanoacrylates. Mixed cyanoacrylate compositions with about 60% to about 90% or more of 2-octyl cyanoacrylate are preferred for use as microbial sealants to prevent the surgical site infections. The present invention provides sterile microbial sealant drape compositions which may be sterilized by the combination of ethylene oxide exposure and E-beam irradiation. Sterile microbial sealant compositions sterilized in this manner provide at least a two year shelf life. The present invention provides microbial sealant drape compositions based on mixed cyanoacrylate monomers, which are packaged in a single use applicator. The applicator includes a compartment containing the microbial sealant composition as well as a sponge applicator tip. Cyanoacrylate-based microbial sealant composition can be readily dispensed onto the sponge applicator tip. A uniform sealing film can be formed by applying the cyanoacrylate-saturated sponge tip onto the surgical sites. The present invention provides microbial sealant drape compositions which are compatible with currently available skin preparation products, surgical incise drapes and wound closure products. The present invention provides microbial sealant drape compositions, which form flexible and tight films on the substrates so that little or no detectable cyanoacrylate residue is transferred into the incision wound by the surgical blade. The present invention provides microbial sealant drape compositions which generate less heat during the application compared to commercially available drape products comprised of 100% butyl cyanoacrylate. The average temperature increase of the skin after applying microbial sealant composition of the present invention is no more than about 0.25° C. The present invention provides microbial sealant drape compositions which provide a high flashpoint for safe use in the operating room or clinical surgery suite. The flashpoint for the disclosed microbial sealant composition is greater than 240° F. which is greater than 100% butyl cyanoacrylate drape products. The present invention provides cyanoacrylate-based microbial sealant drape compositions which form a thin and uniform drape film on the surgical sites. The film thickness of the disclosed cyanoacrylate liquid drape compositions was evaluated using optical microscope, which is less than 500 μm. The present invention provides cyanoacrylate-based microbial sealant drape compositions which has a desirable surface coverage. The average surface coverage of the drape composition disclosed in the present invention device was approximately 222.0 inch 2 . The average surface coverage of the drape composition disclosed in the present invention device is much larger than that of the commercial applicators with the same amount of the liquid sealant. The present invention provides cyanoacrylate-based microbial sealant drape compositions which are compatible with lasers. The microbial sealant films do not ignite, crack, blister or peel under the intense thermal energy of the lasers so that the microbial sealant film maintains its integrity and effectiveness as a sealant on the surgical site. The present invention provides microbial sealant drape compositions which are compatible with defibrillators and electrocautery. The combined use of the disclosed microbial sealant composition with defibrillator and electrocautery does not affect the effectiveness of these devices. The disclosed microbial sealant composition demonstrates desirable performance with regard to charring, plume discoloration and cleaning of the blade upon completion of the incision and coagulation procedures. No signs of ignition, blistering, cracking or peeling were observed. The present invention provides cyanoacrylate-based microbial sealant drape films which provides more resistance to water penetration by impact than the commercial cyanoacrylate films. The microbial sealant composition of the present invention elicited a mean value of 0.03 grams from penetration of water by impact compared to a mean value of 0.07 grams for butyl cyanoacrylate microbial sealant drapes. The present invention provides microbial sealant drape compositions which are less irritating to the skin of a patient than prior art compositions. Based on the skin irritation study, the primary irritation index for the disclosed microbial sealant composition was calculated to be 0.7, while the primary irritation index for butyl cyanoacrylate drapes was calculated to be 1.4. The present invention provides microbial sealant drape compositions which are safe and biocompatible. Cytotoxicity, genotoxicity, local irritation after implantation, and delay-type hypersensitivity of the disclosed microbial sealant compositions were evaluated based on ISO 10993, which confirmed the disclosed compositions are safe to be used as microbial sealant to inhibit the surgical site infections. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 is an illustration of a preferred embodiment of the applicator for the cyanoacrylate microbial sealant drape compositions. DETAILED DESCRIPTION OF THE INVENTION The present invention provides compositions comprising sterile mixtures of cyanoacrylates with different length alkyl chains for use as a liquid microbial sealant drape that can inhibit the surgical site infections. The drape film formed upon polymerization of the mixture of cyanoacrylates prevents the spread of microorganisms by trapping or immobilizing bacteria that survive on patient's skin after common skin preparation procedures. Preferred microbial sealant drape compositions disclosed herein include at least one cyanoacrylate with longer alkyl chain and at least one cyanocrylate with shorter alkyl chain. The longer alkyl chain cyanoacrylates are those containing 5 or more carbon atoms in the alkyl group, which include but are not limited to n-pentyl cyanoacrylate, iso-pentyl cyanoacrylate, n-hexyl cyanoacrylate, iso-hexyl cyanoacrylate, n-heptyl cyanoacrylate, 2-ethylhexyl cyanoacrylate, n-octyl cyanoacrylate, 2-octyl cyanoacrylate, nonyl cyanoacrylate, and decyl cyanoacrylate. The shorter alkyl chain cyanoacrylates are those containing 4 or less carbon atoms in the alkyl group, which include but are not limited to methyl cyanoacrylate, ethyl cyanoacrylate, n-propyl cyanoacrylate, isopropyl cyanoacrylate, n-butyl cyanoacrylate, isobutyl cyanoacrylate, 3-acetoxypropyl cyanoacrylate, 2-methoxypropyl cyanoacrylate, and 3-chloropropyl cyanoacrylate. Varying the composition ratio of cyanoacrylate with different alkyl chains allows modification of the properties of cyanoacrylate compositions so that bonding strength, flexibility, cure time, degradability and biocompatibility can be controlled. Cyanoacrylates with long alkyl chains lacking oxygen-containing functional groups tend to form polymers that degrade slowly. Compared to longer chain cyanoacrylates, the shorter cyanoacrylate monomers have a higher degree of tissue toxicity due to their rapid degradation into formaldehyde and the corresponding cyanoacetate. Polymer films comprising longer alkyl chain cyanoacrylate tend to be more flexible than those made of shorter alkyl chain cyanoacrylates. Shorter alkyl chain cyanoacrylates have advantageous properties as tissue adhesives. For example, shorter alkyl chain cyanoacrylates provide faster curing speed and stronger bond strength as compared to longer alkyl chain cyanoacrylates. In a preferred embodiment of compositions of the present invention, liquid microbial sealant drape compositions comprise 2-octylcyanoacrylate (OCA) in combination with n-butyl cyanoacrylate (BCA). In order to investigate the stability of the mixture of 2-octyl cyanoacrylate and n-butyl cyanoacrylate, a series of mixed cyanoacrylate compositions with different ratio of OCA/BCA were prepared and subjected to sterilization. Sterilization of the compositions is a requirement for their use as microbial sealants. Therefore it is important that the compositions can be sterilized without significant viscosity change. The compositions tested were composed of cyanoacrylates having the following ratios of n-butyl cyanoacrylate to 2-octyl cyanoacrylate: 10:90, 20:80, 30:70, 40:60, 50:50, 60:40, 70:30, 80:20 and 90:10. Table 1 shows the viscosity of the 2-octyl cyanoacrylate and n-butyl cyanoacrylate mixtures before and after the E-beam sterilization. The compositions were sterilized in HDPE bottles (1 ounce). Viscosity change correlates with the stability of cyanoacrylate monomers, stability being an important criterion for selecting the appropriate cyanoacrylate mixture compositions for use as microbial sealants. As shown in Table 1, E-beam sterilization has different effects on different mixtures of 2-octyl cyanoacrylate and n-butyl cyanoacrylate depending on the ratio of the two cyanoacrylates. The viscosity of the different compositions before the sterilization ranges from 3.68 to 3.88 cps and the difference is within the measurement accuracy of the viscometer. Mixed cyanoacrylate compositions having approximately 60% to about 90% 2-octyl cyanoacrylate demonstrate slight viscosity increases after E-beam sterilization. The preferred range of viscosity change is approximately 0% to 200%. The viscosity of the mixed cyanoacrylate compositions having about 50% or less of 2-octyl cyanoacrylate increases dramatically after the E-beam sterilization. This is indicative of instability of those compositions after undergoing E-beam sterilization. Mixed cyanoacrylate compositions having about 20% or less of 2-octyl cyanoacrylate cured after the E-beam sterilization and are unsuitable for microbial sealant compositions. In a more preferred embodiment of compositions of the present invention, compositions with about 60% to about 90% of 2-octyl cyanoacrylate are used as the liquid microbial sealant to prevent the surgical site infections. More preferably, compositions with about 70% to about 90% of 2-octyl cyanoacrylate are used. Even more preferably, compositions with about 80% of 2-octyl cyanoacrylate and about 20% of n-butyl cyanoacrylate is used as the liquid microbial sealant to prevent the surgical site infections. TABLE 1 Viscosity of mixed OCA/BCA compositions before and after E-beam sterilization. Average viscosity (cps) Formulation Composition Before Sterilization After Sterilization 1a 1:9 BCA/OCA 3.68 5.11 1b 2:8 BCA/OCA 3.68 5.71 1c 3:7 BCA/OCA 3.68 5.11 1d 4:6 BCA/OCA 3.88 6.95 1e 5:5 BCA/OCA 3.88 15.77 1f 6:4 BCA/OCA 3.88 68.03 1g 7:3 BCA/OCA 3.68 505.63 1h 8:2 BCA/OCA 3.68 Cured 1i 9:1 BCA/OCA 3.68 Cured In preferred embodiments of the present invention the liquid microbial sealant drape compositions provide at least two-year shelf life. The stability of the sterile cyanoacrylate adhesive compositions has evaluated by the accelerated aging. The accelerated aging test of the mixed cyanoacrylate microbial sealant composition was performed in an oven at 80° C. for a period of 12 days. The investigated compositions were tested for viscosity at intervals of 3, 6, 9 and 12 days. Based on ASTM F1980-2, 12 days accelerated aging at 80° C. correlates to 2 years of shelf life at ambient temperatures. Table 2 shows the viscosity of a sterile microbial sealant composition in an applicator containing 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanaocrylate at day 0, 3, 6, 9 and 12 of the accelerated aging at 80° C. The viscosity of the cyanoacrylate-based microbial sealant compositions increases as the accelerated aging proceeds but the increased viscosity of the aged samples at day 12 does not affect the performance of liquid drape compositions nor the dispensing of the compositions from the applicator. TABLE 2 Viscosity of the sterile microbial sealant drape composition before and after the accelerated aging at 80° C. for 12 days. Viscosity (cps) Test 1 Test 2 Test 3 Average Day 0 4.29 3.68 3.06 3.68 Day 3 4.29 3.68 4.90 4.29 Day 6 4.90 4.90 5.52 5.11 Day 9 6.13 6.13 6.74 6.33 Day 12 27.0 25.7 30.6 27.8 In preferred embodiments of the present invention the microbial sealant drape composition is packaged in a user-friendly, single use applicator. As shown in FIG. 1 , the applicator comprises a compartment containing the mixed cyanoacrylate compositions and a sponge applicator tip through which the liquid drape compositions may be applied to the surgical site. The applicator compartment is preferably air and water tight with a sealing mechanism to prevent contamination to the mixed cyanoacrylate monomers inside. When the compartment is opened, the mixed cyanoacrylate liquid sealant is evenly distributed onto the sponge applicator tip. Cyanoacrylate liquid drape compositions can be easily dispensed onto the sponge from an applicator once the sponge connection is folded. A uniform sealing film is formed by applying the cyanoacrylate-saturated sponge tip onto surgical sites. According to the present invention, the microbial sealant drape compositions of the present invention can effectively reduce the amount of microorganisms in the surgical site. In preferred embodiments the microbial sealant compositions are at least 99.9% effective in preventing the spread of the clinically relevant bacteria on the surgical sites under a variety of usage conditions. The in vitro immobilization of microorganisms by the microbial sealant compositions was evaluated using sterile pig skin incised with a sterile surgical scalpel. Microorganisms used to challenge the surgical site may include without limitation pathogenic gram negative bacteria, gram positive bacteria, yeast and Corynebacterium sp. The immobilization of microorganisms by the microbial sealant compositions of the present invention was evaluated under different conditions which included without limitation using the microbial sealant composition without incision, using the microbial sealant composition with incision, using the microbial sealant composition with incision and skin surgical preps, and using the microbial sealant composition with incision and surgical incise drapes. The microbial sealant drape compositions of the present invention were effective in preventing the mitigation in the test organism on the surgical site. Complete effectiveness was manifest as greater than 3.9 log 10 mitigation in the case of S. epidermidis , MRSA, Corynebacterium species, Pseudomonas aeruginosa and greater than 4 log 10 mitigation for Candida albicans . The microbial sealant compositions do not have an adverse effect on the effectiveness of surgical preps. The microbial sealant compositions do not need to be used in combination with an antimicrobial surgical incise drape. Instead the microbial sealant compositions of the present invention may be used as a substitute for an antimicrobial surgical incise drape. According to the present invention, the preferred microbial sealant drape compositions can reduce microbial colonization by at least 99.9% within 15 minutes of application and maintain at least a 99.9% reduction throughout the 24 hours post treatment According to the present invention, the microbial sealant drape compositions are resistant to the passage of blood-borne pathogens. Testing based on ASTM F1671 “Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System” was conducted to demonstrate the pathogen resistance. The test results indicated that the disclosed microbial sealant film is resistant to the passage of blood-borne pathogens using a viral penetration as a test system. Preferred microbial sealant drape compositions of the present invention generate less heat during the application compared to commercially available drape products. Polymerization of cyanoacrylate is an exothermic process. The amount of heat released during polymerization is related to the length of the alkyl chain of the cyanoacrylate. Cyanoacrylates with shorter length chains release more heat. Too much heat generated from the application of cyanoacrylates onto human skin makes the patient uncomfortable. The exothermic effect of microbial sealant product of the present invention and a commercially available product was evaluated using an Infrared Thermometer to measure the temperature change on human skin. The skin temperature of patients was measured before and after the application of the drape products onto human skin. The average temperature increase after applying microbial sealant composition disclosed in the present invention and a commercially available product were 0.25 and 0.41° C., respectively. The test results indicate that less heat is released from the application of the preferred composition disclosed in the present invention than that of a commercially available product. According to the present invention, the microbial sealant drape compositions of the present invention have a high flashpoint for safe use in the operating room or clinical surgery suite. The test was performed in accordance with ASTM D56-05, ISO 3679:2004 determination of flashpoint-rapid equilibrium closed cup method. The flashpoint for the microbial sealant compositions of the present invention is greater than 240° F. The flashpoint of the 100% butyl cyanoacrylate microbial sealant compositions is about 227° F. According to the present invention, no cyanoacrylate residue was detected on a surgical blade through which an incision was made on a substrate covered with a microbial sealant drape compositions disclosed herein. The detection limit of the test was 5 ppm. The residue analysis on a surgical blade confirmed that no detectable cyanoacrylate sealants were transferred into the incision wound site. According to the present invention, the preferred microbial sealant drape compositions of the present invention provide a desirable degradation profile. The integrity (degradation over time) of the disclosed microbial sealant film was evaluated following topical application to the skin of three pigs and comparisons were made to commercially available drapes. The microbial sealant films applied at each application site were evaluated for degradation at approximately 8 hours after application, and 1, 2, 3, 4, 6, 8, 10, 12, 14, and 16 days after application. Degradation of both the disclosed microbial sealant film and the commercial product was evident by the first observation interval (8 hours after application). At this time, 2 out of 12 test sites with the disclosed microbial sealant film remained intact and 5 out of 12 sites with the predicate device were intact. When the study ended on day 16, the microbial sealant film of the present invention was partially present in 2 of the 12 sites, while the commercial product was absent from all 12 sites. According to the present invention, the liquid microbial sealant compositions are compatible with currently available skin preparation products, surgical incise drape products and wound closure products. Compatibility with current products means that the application of the disclosed microbial sealant drape composition does not adversely affect the performance of wound closure products and surgical incise drapes. Skin preparation products that may be used in concert with the compositions of the present invention include without limitation Chloraprep, Duroprep, 10% Povidone iodine and Betadine. Duraprep is preoperative skin preparation product comprising iodine povacrylex and isopropyl alcohol. ChloraPrep is a rapid-acting, persistent, and broad-spectrum preoperative skin preparation product, which consists of 2% Chlorhexidine Gluconate in 70% isopropyl alcohol. Betadine is a consumer-available topical antiseptics containing 10% of povidone-iodine. Surgical incise drapes may also be used with the cyanoacrylate compositions of the present invention including without limitation 3M Steri-strip and Ioban 2. Steri-Strip is an antimicrobial skin closure product that is made of a porous, non-woven backing coated with a pressure-sensitive adhesive which contains iodophor and is reinforced with polyester filaments for improved strength. Ioban 2 is an antimicrobial surgical incise drape with an iodophor impregnated adhesive providing a sterile surface and antimicrobial activity throughout the procedure. The compatibility of the preferred liquid microbial sealant compositions with current commercial products used for preventing surgical site infections was investigated by observing the effect of the disclosed liquid drape product on the adhesion property of surgical incise drape in the absence and presence of different skin preparation products. The liquid cyanoacrylate sealant compositions of the present invention are also compatible with currently available wound closure products. The wound closure products may include SurgiSeal, Dermabond and Steri-Strip. Dermabond is a liquid bonding adhesive that holds cuts, incisions and wounds together. SurgiSeal is cyanoacrylate-based topical skin adhesive for the closure of wound and incisions to provide a flexible, water-resistant, antimicrobial protective coating, which provides the optimal balance between bond strength and flexibility. According to the present invention, the preferred liquid cyanoacrylate sealant drape composition is compatible with lasers. The lasers that may be used in concert with the compositions of the present invention include without limitation CO 2 , Nd:YAG, and Diode. The disclosed microbial sealant is intended to be used after typical operative skin preparation prior to a surgical incision. Lasers may be required to be used for skin incision, ablation, or coagulation for a surgical procedure. The in vitro study was conducted to evaluate the effect of both free beam and contact use of the lasers on the disclosed microbial sealant film formed on pig skin. The combined use of a skin prep such as Betadine with the disclosed microbial sealant composition was also investigated using a Diode laser. The integrity of the disclosed microbial sealant film was evaluated by macroscopic observations for cracking, blistering and peeling. The intense thermal energy of the lasers was used to determine if the disclosed microbial sealant film would ignite. The results showed that the disclosed microbial sealant film did not ignite, crack, blister or peel for all three laser types when used with either free beam or contact thermal energy applications so that the microbial sealant maintains its integrity and effectiveness as a sealant for the surgical procedure. These same results were obtained when combined with the surgical skin preparation product when the Diode laser was used with either free beam or contact laser. According to the present invention, the cyanoacrylate-based microbial sealant compositions are compatible with defibrillators and an electrocautery. The in vitro study was conducted on porcine skin to evaluate the effect of the microbial sealant compositions of the present invention on the performance of the defibrillator and electrocautery. The microbial sealant composition was applied onto porcine skin. A metal plate or probe was attached on the underneath side of the porcine skin to measure the voltage of the defibrillator. In order to evaluate the compatibility with Electrocautery, a commercially available Electrocautery device was used to make incisions and coagulations on the porcine skins covered with the disclosed microbial sealant film. The Electrocautery settings were made at 70 watts for both incision and coagulation. The single coat application of the microbial sealant compositions of the present invention did not significantly decrease the conductance of the energy being discharged from the defibrillator. There was no observation of ignition, blistering, cracking or peeling. When used with the electrocautery, the microbial sealant compositions demonstrated desirable performance with regard to charring, plume discoloration and cleaning of the blade upon completion of the incision and coagulation. According to the present invention, the cyanoacrylate liquid drape compositions provide a thin and uniform film on the surgical sites. In preferred embodiments of the present invention the drape film has a thickness of from about 5 to about 400 μm. More preferably, the drape film provides a thickness of about 10 to 200 μm, more preferably from about 30 to 80 μm and still more preferably from about 50 to 60 μm. The film thickness study indicates the formation of thin and uniform films of the disclosed liquid drape compositions. According to the present invention, the liquid microbial sealant drape compositions provide greater resistance to penetration of water by impact than the commercially available liquid drapes. The resistance of the microbial sealant compositions of the present invention to the penetration of water by impact was investigated according to the American Association of Textile Chemists and Colorists (AATCC) test method. A volume of water is allowed to spray against the taut surface of the disclosed microbial sealant film backed by a weighted blotter. The blotter was then reweighed to determine water penetration. The microbial sealant compositions of the present invention have an average value of 0.03 grams from penetration of water by impact compared to an average value of 0.07 grams for a commercial drape composition. The test results indicate that the disclosed microbial sealant composition provides twice more resistance to water penetration by impact than the commercial product. According to the present invention, the cyanoacrylate liquid sealant drape compositions are safe and effective as a surgical sealant product useful for inhibiting surgical site infections. The safety and biocompatibility of the disclosed liquid drape composition has been evaluated based on the International Organization for Standardization (ISO) 10993, Biological Evaluation of Medical Devices. Cytotoxicity was measured on the preferred liquid microbial sealant composition using an in vitro biocompatibility study. The liquid microbial sealant compositions of the present invention are not cytotoxic. For comparison, the in vitro cytotoxicity of prior art device was also evaluated, which showed no evidence of causing cell lysis or toxicity. According to the present invention, the preferred liquid cyanoacrylate-based microbial sealant drape composition is less irritating than the prior art device, which was confirmed by the primary skin irritation study and ISO intracutaneous study. According to the present invention, the preferred liquid microbial sealant drape composition is not genotoxic. Bacterial reverse mutation test, mouse peripheral blood micronucleus study and in vitro chromosomal aberration study in mammalian cells confirmed that the compositions are not genotoxic. The mixed cyanoacrylate compositions may be stabilized with a combination of free radical stabilizer and anionic stabilizer. In embodiments of the present invention, the preferred primary free radical stabilizer is butylated hydroxyl anisole (BHA). BHA is used in an amount of about 200 to about 15000 ppm, preferably about 1000 to about 10000 ppm, more preferably about 2000 to about 8000 ppm. Other free radical stabilizers that may be used include without limitation, hydroquinone; catechol; hydroquinone monomethyl ether and hindered phenols such as butylated hydroxyanisol; 4-ethoxyphenol; butylated hydroxytoluene (BHT, 2,6-di-tert-butyl butylphenol), 4-methoxyphenol (MP); 3-methoxyphenol; 2-tert-butyl-4methoxyphenol; 2,2-methylene-bis-(4-methyl-6-tert-butylphenol). In embodiments of the present invention, the preferred primary anionic stabilizer is sulfur dioxide in an amount of about 2 to about 500 ppm, preferably from about 10 ppm to about 200 ppm. The anionic stabilizer may be a very strong acid including without limitation perchloric acid, hydrochloric acid, hydrobromic acid, toluenesulfonic acid, fluorosulfonic acid, phosphoric acid, ortho, meta, or para-phosphoric acid, trichloroacetic acid, and sulfuric acid. The very strong acid may be used in an amount of 0 to about 250 ppm, preferably from about 5 ppm to 50 ppm. Preferably, the very strong acid stabilizer is sulfuric acid, phosphoric acid or perchloric acid. According to the present invention, the cyanoacrylate-based microbial sealant drape compositions are sterilized for medical use. The sterilization can be accomplished by common techniques, and is preferably accomplished by methods including, but not limited to, chemical, physical, and irradiation methods. An example of a chemical method includes, but is not limited to, exposure to ethylene oxide. Examples of irradiation methods include, but are not limited to, gamma irradiation, electron beam irradiation (E-beam), and microwave irradiation. In preferred embodiments of the present invention, E-beam is used to sterilize the cyanoacrylate-based microbial sealant compositions. The dose of E-beam irradiation applied should be sufficient enough to sterilize both the package and the adhesive inside. The E-beam irradiation may be in a dosage of from about 5 to 50 kGy, and more preferably from about 12 to about 25 kGy. E-beam irradiation is preferably conducted at ambient atmosphere conditions and the exposure time to the irradiation is preferably from about 1 to about 60 seconds, more preferably from about 10 seconds to 60 seconds. In preferred embodiments of the present invention, the viscosity of the preferred cyanoacrylate-based microbial sealant composition changes upon the E-beam sterilization. The average viscosity of the preferred microbial sealant drape composition comprising 20% butyl cyanoacrylate and 80% octyl cyanoacrylate before sterilization is 3.68 cps. After the sealant composition is subjected to E-beam sterilization the viscosity was measured to be 5.71 cps. The prior art references indicate that E-beam sterilization can induce serious partial polymerization of cyanoacrylate, which would lead to a large increase in viscosity. In order to reduce the bioburden, the cyanoacrylate-based microbial sealant drape compositions may be filtered through a 0.2 μm filter. The applicators with the overpack may also be sterilized with heat, ethylene oxide prior to the final E-beam irradiation. The sterility of the cyanoacrylate-based microbial sealant drape compositions may be analyzed by Bacteriostasis and Fungistasis tests. In embodiments of the present invention, a Sterility Assurance Level (SAL) should be obtained at a minimum of 10 −3 , which means that the probability of a single unit being non-sterile after sterilization is 1 in 1000. In more preferred embodiments, the Sterility Assurance Level may be at least 10 −6 . The following non-limiting examples are intended to further illustrate the present invention. EXAMPLE 1 Setting Time Measurement Pig skin (4×4 square inch) was prepared by wiping the surfaces of the skin with sterile gauze saturated with isopropanol. All oily substances were thereby removed from the pig skin. The surface was wiped with sterile gauze to remove the isopropanol. The applicator containing the microbial sealant composition was opened and adhesive was permitted to saturate the sponge applicator tip for about 10 seconds prior to application. A thin film was applied to the pig skin after which elapsed time was recorded by a stop watch. Set time was then recorded by stopping the clock when the film was dry as determined at the point where no liquid transfer occurred when the film was touched with a gloved finger. EXAMPLE 2 Viscosity Measurement The viscosity of the cyanoacrylate compositions were measured by the Brookfield DV-II+ viscometer. The spindle and cup were cleaned with acetone after each measurement. About 0.5 ml of the microbial sealant composition was put into the cup and the cup was brought into position and slowly secured with the retaining arm. The motor was turned on after the sample was equilibrated in the cup. The viscosity of the disclosed microbial sealant composition was measured in triplicate. Any residue was removed with acetone prior to next sample measurement. EXAMPLE 3 Average Set Time and Viscosity for Cyanoacrylate Mixtures To a polyethylene bottle equipped with a magnetic stir bar, 24 g of n-butyl cyanoacrylate (BCA) was mixed with 56 g of 2-octyl cyanoacrylate (OCA) at room temperature for 4 hours (Composition 1). To a polyethylene bottle equipped with a magnetic stir bar, 32 g of n-butyl cyanoacrylate (BCA) was mixed with 48 g of 2-octyl cyanoacrylate (OCA) at room temperature for 4 hours (Composition 2). 3 lbs of n-butyl cyanoacrylate (BCA) was mixed with 12 lbs of 2-octyl cyanoacrylate (OCA) in a plastic container at room temperature for 4 hours. A trace amount of D & C Violet #2 was included in BCA and OCA as the colorant (Composition 3). Each of the three compositions was tested for average set time and average viscosity, as shown in Table 3. TABLE 3 Average viscosity and set time of the preferred microbial sealant compositions. Composition Avg. set time Avg. viscosity Composition 1 24.5 s 3.68 cps Composition 2 27.8 s 3.88 cps Composition 3 22.3 s 3.88 cps EXAMPLE 4 Effect of the Preferred Microbial Sealant Composition on the Wound Closure Strength of Steri-Strip A skin model was used to evaluate the effect of the disclosed microbial sealant drape composition on the wound closure strength of commonly used wound closure products, 3M Steri Strips. Three (3) pig skin squares of skin model were randomly assigned to each of the following: a) no preparation product (untreated); b) liquid microbial sealant alone; c) Chloraprep alone; d) liquid microbial sealant drape applied over Chlorprep; e) Duroprep alone; f) liquid microbial sealant drape applied over Duroprep; g) Betadine alone; and h) liquid microbial sealant drape applied over Betadine. Following preparation of the incision site with skin preparation products and/or the disclosed liquid microbial sealant drape, an incision was made in the middle of the pig skin. The incisions were then closed with different wound closure products. After wound closure, the pig skin incisions were pulled apart using a Mark-10 tensiometer at a speed of 25 mm/min to determine wound closure strength. The data is summarized in Table 4. TABLE 4 The Average Force Required for Separating Wound Closure of Steri-Strip on a Skin Model Average Sample 1 Sample 2 Sample 3 Force (lb-min/ (lb-min/ (lb-min/ (lb-min/ Sample Name sq in) sq in) sq in) sq in) Untreated 3.0 3.2 3.2 3.13 Liquid microbial sealant 9.4 7.6 8.8 8.60 Betadine 1.6 1.8 1.2 1.53 Betadine and Liquid 8.2 7.6 6.2 7.33 mcirobial sealant Chloraprep 3.0 3.0 3.2 3.07 Chloraprep and Liquid 10.6 7.8 7.0 8.47 microbial sealant Duraprep 2.4 3.0 2.2 2.53 Duraprep and Liquid 9.0 12.2 10.8 10.67 microbial sealant EXAMPLE 5 Surface Coverage of the Disclosed Microbial Sealant Applicator A liquid microbial sealant composition comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate was applied to pig skins from an applicator until all the adhesive (3.5 mL) was dispensed. The length and width of the covered areas was measured with electronic digital calipers. These values were used to calculate the surface coverage per applicator. The surface coverage was measured according to the following procedures. A 4×12 inch of pig skin was prepared by wiping the surfaces of the skin with sterile gauze saturated with isopropanol to make sure that all oily substances were removed from the pig skin. The surface of the skin was wiped dry with gauze. The microbial sealant composition was applied to the prepared pig skin until the entire adhesive in a single applicator was distributed (3.5 ml). The whole area of the pig skin was covered by diminishing the gap and overlap as much as possible and by keeping the strokes even. The width and length of pig skin covered with adhesive was measured using an electronic digital cather. The surface area was calculated from the measured width and length. The average surface coverage of the drape composition disclosed in the present invention device was approximately 222.0 inch 2 . EXAMPLE 6 Film Thickness The drape film thickness was measured using optical microscopy. The drape film compositions comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate were prepared by applying the drape composition from the applicator onto two adjacent glass slides. The cyanoacrylate compositions were allowed to dry. A razor blade was used to make a cut between the two glass slides to create a cross section in the cured film that was approximately in line with the glass slide edges. The glass slide with the cured drape film was mounted with a clamp on the metallographic microscope such that the cross section of the slide and the cured film could be viewed by optical microscopy. The specimen was magnified with the 20× lens. A series of measurements of film thickness were made by comparing the images of the samples with a standard optical image photographed at the same camera and microscope settings. Three measurements per sample were made per photograph and three photographs were taken per film for a total of 9 measurements per film. Under the test condition, the microbial sealant film has a thickness of less than about 500 μm. EXAMPLE 7 Cytotoxicity Cytotoxicity was tested on a microbial drape composition comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate using an in vitro biocompatibility study based on ISO 10993, Part 5. The disclosed liquid drape composition was applied to both sides of a glass slide to cover an area 15 mm by 75 mm. The coated slides were allowed to dry prior to placing them into a container for extraction. The test article was extracted with a single strength Minimum Essential Medium (1×MEM) with 5% serum and 2% antibiotics. The test extract was placed onto three separate monolayers of L-929 mouse fibroblast cells propagated in 5% CO 2 . High density polyethylene was used as the negative control and tin stabilized polyvinylchloride was used as the positive control. All monolayers were incubated at 37° C. in the presence of 5% CO 2 for 48 hours, which was then examined microscopically to determine any change in cell morphology. The liquid microbial sealant compositions of the present invention did not cause cell lysis or toxicity. EXAMPLE 8 Genotoxicity Study I A glass rod was cleaned with 70% isopropyl alcohol and allowed to air dry. The rod was then coated with a microbial sealant drape composition comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate up to 4 cm and allowed to dry for at least 1 minute prior to extraction with dimethyl sulfoxide (DMSO) and 0.9% sodium chloride at 37° C. for 72 hours. Another glass rod without cyanoacrylate liquid drape was similarly subjected to the extraction conditions for use as a negative control. Known mutagens, benzo[a]pyrene and 2-nitrofluorene, were used as positive control to demonstrate that tester strain TA 98 was sensitive to mutation reversion to wild type. For tester strains TA100 and TA 1535, sodium azide and 2-aminoanthracene were used as positive controls. For tester 1537, 2-aminoanthracene and ICR-191 were used as positive controls. For tester strain WP2uvrA, 2-aminoanthracene and methylmethane-sulfonate were used as positive controls. Tubes containing molten top agar supplemented with tryptophan for the Escherichia coli or with histidine-biotin solution for the Salmonella typhimurium were inoculated with culture for each of the five tester strains and with the DMSO and saline extracts of the disclosed cyanoacrylate liquid drape film. Sterile water for injection (SWI) or S9 homogenate simulating metabolic activation was added as necessary. Trytophan-free media plates (for E. coli ) and histidine-free media plates (for S. typhimurium ) were prepared in triplicate as follows: 1) DMSO and saline extracts of the cyanoacrylate liquid drape film with and without S9 activation; 2) negative controls with and without S9 activation; and 3) positive controls with different tester strains in the absence and presence of S9 activation. The plates were incubated at 37° C. for 2 to 3 days. Following the incubation period, the revertant colonies on each plate were recorded. The mean number of revertants and standard deviation was determined. The mean number of revertants of the test plates was compared to the mean number of revertants of the negative control for each of the five tester strains. It was concluded that, under the study conditions, the disclosed liquid microbial sealant compositions in both DMSO and saline extracts were not mutagenic to Salmonella Typhimurium strains (TA98, TA100, TA1535, and TA1537), and were not mutagenic to tryptophan-dependent Escherichia coli strain WP2uvrA. EXAMPLE 9 Genotoxicity Study II A glass rod was cleaned with 70% isopropyl alcohol and allowed to air dry, and then coated with the microbial sealant drape compositions comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate up to 4 cm. The drape was allowed to dry for at least 1 minute prior to extraction with dimethyl sulfoxide (DMSO) and 0.9% sodium chloride at 37° C. for 72 hours. Additional test rods without cyanoacrylate microbial sealant were subjected to the same extraction conditions as the test article and were used as negative controls. Methyl methanesulfonate (MMS) in saline, an antineoplastic drug known to have mutagenic properties, was used as a positive control. Five groups of mice, each of which consisted of 6 male and 6 female, were injected with cyanoacrylate liquid drape in SC extract, cyanoacrylate liquid drape in SO extract, negative control in SC, negative control in SO, and positive control with methyl methanesulfonate, respectively. Each mouse received an intraperitoneal injection at a dose of 20 ml/kg of the appropriate extract accordingly for consecutive three days. All animals were observed immediately following injection and on a daily basis to access general health. On day 4, blood was collected from the tail veins of each mouse and solutions were prepared. The normochromatic erythrocytes were evaluated for the presence of micronuclei. The frequency of micronucleated reticulocytes (MN-RETs) was determined and used as an index of genotoxicity. The frequency of reticulocytes relative to total erythrocytes was calculated as an indication of stem cell toxicity. Both SC and SO extracts of the cyanoacrylate liquid drapes of the present invention did not show statistically significant increases in the frequency of MN-RETs. Cyanoacrylate liquid microbial sealant compositions of the present invention are not genotoxic under the study conditions. Also, there was no evidence of cellular toxicity from extracts of the disclosed cyanoacrylate liquid drape composition. EXAMPLE 10 Local Irritation and Toxicity Study Local irritation or toxicity effect after implantation of the microbial sealant drape compositions comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate was conducted to evaluate the potential for a local irritant or toxic response to the drape implanted in direct contact with muscle tissue. High density polyethylene was used as the negative control. Three Albino New Zealand rabbits were used for the test. One incision was made on each side of the rabbit back. The fascia was cut to expose the paravertebral muscle. A pocket was formed with a hemostat between the muscle fibers into which the implant material was introduced. After four weeks, the rabbits were weighed and then euthanized by an intravenous injection of a sodium pentobarbital based drug. The paravertebral muscles were dissected free and fixed in 10% neutral buffered formalin to facilitate cutting. The tissue was macroscopically examined using low magnification to look for capsule formation or other signs of irritation. The excised sections were also histologically processed for microscopic evaluations. The disclosed microbial sealant drapes of the present invention caused no macroscopic reaction under the study conditions, while microscopic examination indicated the disclosed composition was moderately irritating to the tissue. EXAMPLE 11 ISO Intracutaneous Study Intracutaneous study of microbial sealant drape compositions comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate was conducted to determine whether leachables extracted from the disclosed microbial sealant composition wound cause local dermal irritant effects following injection into rabbit skin. The glass rods were wiped clean with 70% isopropyl alcohol and allowed to air dry. The glass rod was coated with the disclosed microbial sealant compositions up to 4 cm and allowed to air dry for at least one minute prior to placing in the extraction container. The test article was extracted in 0.9% sodium chloride USP solution (SC) and sesame oil, NF 9 (SO) at 37° C. for 72 hours. A 0.2 ml dose of the test article extract was injected by the intracutaneous route into five separate sites on the right side of the back of each rabbit. Injections were spaced approximately 2 cm apart. The appearance of each injection site was noted immediately after injection. Observations for erythema and edema were conducted at 24, 48, and 72 hours after injection. Under the conditions of this study, there was no erythema and no edema from the SC extract injected intracutaneously into rabbits. There was very slight erythema and very slight edema from the SO extracts injected intracutaneously into rabbits. EXAMPLE 12 ISO Skin Irritation Study Skin irritation study of cyanoacrylate-based microbial sealant drape compositions comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate was conducted to evaluate the potential for a single topical application of the disclosed microbial sealant composition to irritate skin. New Zealand white male rabbits were used for this study. On the day of treatment, four sites, two on each side of the back cranially and caudally, were designated on each rabbit. A 0.5 ml portion of the disclosed microbial sealant composition was applied topically to each cranial site by introduction under a 4 ply gauze layer to an area of skin approximately 25 mm×25 mm square. The patches were backed with plastic and covered with a nonreactive tape. After the 24 hour exposure, the binders, tape and patches were removed. The sites were graded for erytherma and edema at 1, 24, 48 and 72 hours after removal of the single sample application. Under the conditions of the study, very slight erythema and no edema were observed on the skin of the rabbits. The primary irritation index for the disclosed microbial sealant composition was calculated to be 0.7. EXAMPLE 13 Residue Analysis The residue analysis on surgical blade was determined on a pig skin model. A microbial sealant drape composition comprising 20% butyl cyanoacrylate and 80% octyl cyanoacrylate was applied to pig skin as the sealant before incision. An incision was made through the drape film using a surgical blade. The surgical blade was then immersed in HPLC grade acetone to extract any possible cyanoacrylate residue. The acetone solution after extraction was analyzed by GC/MS to determine if any residual cyanoacrylate was left on the blade after an incision was made. The fresh surgical blade cutting through pig skin without treatment by microbial sealants served as a negative control. Solution of polymer film of the preferred microbial sealant composition in acetone was used as the positive control to determine the detection limit of GC/MS. In order to determine the limit of detection, positive controls were run and various peaks were compared to determine which peaks were best for assessing the presence of the materials. A peak associated with cyanoacrylate at 14.7 minutes was found to be best for quantification and detection of cyanoacrylate. At 5 ppm, the peak at 14.7 minutes for cyanoacrylate was observed clearly with a large ratio of signal/noise, which was thus assigned as the detection limit. Following the same condition used for the positive control, the residual analysis of surgical blade used to cut through the drape film of the preferred compositions in the present invention was conducted. No cyanoacrylate was detected indicating that no residue of the disclosed drape composition on surgical blade was found at the detection limit of 5 ppm. There was no cracking, blistering or flaking of the drape film observed when the incision was made on the microbial sealant of the preferred composition disclosed herein. These observations suggest that the microbial sealant compositions disclosed in the present invention provide the desirable flexibility and strong bonding strength. EXAMPLE 14 Adhesion Properties A pig skin model was used to evaluate the effect of the disclosed microbial sealant drape compositions on the adhesion property of the commonly used surgical incise drapes with and without the treatment of the skin preparation products. The following treatments were subjected to the pig skin model test: a) no preparation product (untreated); b) liquid microbial sealant alone; c) Chloraprep alone; d) liquid microbial sealant applied over Chlorprep; e) Duroprep alone; f) liquid microbial sealant applied over Duroprep; g) 10% Povidone Iodine alone; and h) liquid microbial sealant applied over 10% Povidone Iodine. The skin model was prepared by applying different skin preparation products and the liquid microbial sealant, after which a surgical incise drape such as 3M Steri-Strip and Ioban 2 was applied to the surface of each model. The surgical incise drape was then peeled away from the skin model using a Mark-10 tensiometer to determine the adhesion strength of the incise drape at a speed of 50 mm/min. Table 5 shows the average force required to peel Steri-strip from the pig skin treated under various conditions. Compared to skin models untreated or treated only with skin preparation products, the adhesion strengths of Steri-Strip on skin models with the liquid microbial sealants of the present invention are 2-3 times greater. The test results demonstrate that the use of the disclosed liquid drape composition improves the adhesion strength of the commonly used surgical incise drapes. The surgical incise drape provides increased adhesion strength when applied to the substrates sequentially treated with the skin preparation products and the liquid microbial sealants compared to those applied to the substrates treated only with the skin preparation products. These observations indicate that the disclosed liquid microbial sealant is compatible with commercial surgical incise drapes and skin preparation products and provides increased adhesion strength. TABLE 5 Average strength required to peel Steri-strip from the pig skin model Treatment Average strength (lb/in 2 ) Untreated 0.67 Liquid microbial sealant 1.40 A commercial liquid drape 1.20 Povidone iodine 0.67 Povidone iodine + liquid microbial sealant 1.67 Povidone iodine + a commercial liquid drape 1.40 Chloraprep 0.67 Chloraprep + liquid microbial sealant 1.20 Chloraprep + a commercial liquid drape 1.20 Duroprep 0.53 Duroprep + liquid microbial sealant 1.67 Duroprep + a commercial liquid drape 1.33 EXAMPLE 15 Compatibility with Wound Closure A pig skin model was used to evaluate the effect of the disclosed microbial sealant drape composition on the wound closure strength of the wound closure products with and without pre-treatment with skin preparation products. The testing skin models were randomly assigned to the following treatments: a) no preparation product (untreated); b) liquid cyanoacrylate microbial sealant alone; c) Chloraprep alone; d) liquid microbial sealant applied over Chlorprep; e) Duroprep alone; f) liquid cyanoacrylate microbial sealant applied over Duroprep; g) Betadine alone; and h) liquid cyanoacrylate microbial sealant applied over Betadine. Following preparation of the incision site with skin preparation products and/or the disclosed liquid microbial sealant, an incision was made in the middle of the pig skin. The incisions were then closed with different wound closure products. After wound closure, the pig skin incisions were pulled apart after 1-2 minutes using a Mark-10 tensiometer at a speed of 25 mm/min to determine the wound closure strength. The average wound closure strength of SurgiSeal in the absence and presence of different skin preparation products and/or the liquid microbial sealant drape compositions of the present invention is summarized in Table 4. The disclosed liquid drape composition and different skin preparation products including Betadine, Chlorprep and Duraprep, were evaluated for the effect on the wound strength of SurgiSeal. As shown in Table 6, the wound closure strength of SurgiSeal in the presence of the liquid microbial sealant is slightly greater than that in the absence of the liquid microbial sealant. Likewise, the wound closure strength of other wound closure products such as Dermabond and Steri-strip is stronger liquid microbial sealant drapes of the present invention are applied as compared to that without applying the liquid cyanoacrylate microbial sealant. These observations indicate that the disclosed liquid cyanoacrylate microbial sealant is compatible with commercially available wound closure products and provides for improved closure strength. TABLE 6 The Average Force Required for disrupting Wound Closure of SurgiSeal on a Skin Incision Model Treatment Average strength (lb) Untreated 4.5 Liquid microbial sealant 8.9 Betadine 4.7 Betadine + liquid microbial sealant 6.9 Chloraprep 4.7 Chloraprep + liquid microbial sealant 5.9 Duroprep 4.8 Duroprep + liquid microbial sealant 6.1 EXAMPLE 16 Skin Irritation Skin irritation study of a cyanoacrylate-based liquid microbial sealant drape compositions comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate was conducted to evaluate the potential for a single topical application of the disclosed microbial sealant composition to irritate skin. New Zealand white male rabbits were used for this study. Under the conditions of this study, very slight erythema and no edema were observed on the skin of the rabbits for the disclosed microbial sealant composition. The primary irritation index for the disclosed microbial sealant composition was calculated to be 0.7, while the primary irritation index for the predicate device was calculated to be 1.4. EXAMPLE 17 Intracutaneous Study Intracutaneous study of the microbial sealant drape compositions comprising 80% of 2-octyl cyanoacrylate and 20% of n-butyl cyanoacrylate was conducted to determine whether leachables extracted from the disclosed microbial sealant composition wound cause local dermal irritant effects following injection into rabbit skin. For comparison, the corresponding study was also conducted for a commercial liquid drape. The test article was extracted in 0.9% sodium chloride USP solution (SC) and sesame oil, NF 9 (SO). A 0.2 ml dose of the test article was injected by the intracutaneous route into five separate sites on the right side of the back of each rabbit. Observations for erythema and edema were conducted at 24, 48, and 72 hours after injection. As shown in Table 7, there was no erythema and no edema from the SC extract of the disclosed microbial sealant composition injected intracutaneously into rabbits. There was very slight erythema and very slight edema from the SO extract of the disclosed microbial sealant composition injected intracutaneously into rabbits with a mean difference score of 0.3. In comparison, there was well-defined to moderate erythema and well-defined to severe edema from the SO extract of a commercial liquid drape, injected intracutaneously into rabbits with a mean difference score of 2.1. TABLE 7 Summary of ISO intracutaneous study Test group Control group Mean difference Test article Extract mean score mean score score (test − control) 20% BCA and 80% SC 0.0 0.0 0.0 OCA SO 0.8 0.5 0.3 A commercial liquid SO 2.6 0.5 2.1 drape SCORE ERYTHEMA EDEMA 0 No erythema No edema 1 Very slight erythema (barely Very slight edema (barely perceptible) perceptible 2 Well-defined erythema Well-defined edema (edges of area well-defined by definite raising) 3 Moderate erythema Moderate edema (raised approximately 1 mm) 4 Severe erythema (beet redness) to Severe edema (raised more than 1 mm, eschar formation preventing grading and extending beyond exposure area) of erythema EXAMPLE 18 In Vitro Bacteria Immobilization Sterile pig skin, 4×4 inches, was aseptically cut into 4×1 cm pieces. Each piece of the sterile pig skin was inoculated with 0.1 mL (about 75,000 colony forming units) of MRSA, S. epidermids, Pseudomonas aeruginosa, Candida albicans , or Corynebacterium sp. to a marked 4×1 cm area of the skin. The incision site was defined by a metric ruler to the depth of the fat layer below the dermis and length of about 4 cm. The inoculated skin was placed under a laminar flow hood to allow the inoculum to dry at ambient laboratory temperature. A microbial sealant composition comprising 20% butyl cyanoacrylate and 80% octyl cyanoacrylate was then applied onto the inoculated skin over the incision site. An incision was then made with a sterile scalpel and the pig skin was manipulated by gently squeezing the incision site to simulate surgical trauma. Excess skin was cut away from the incision site with a sterile scalpel. To determine whether organism had migrated from the skin surface to the incision site, the incision site was irrigated with 0.1 mL of sterile elution fluid and the eluate was collected. Ten-fold serial dilutions of the eluate were prepared and duplicate pour plate counts and membrane filtration count were performed. The agar plates were incubated for 48 to 72 hours at 35-37° C. Analysis of data shows that the disclosed microbial sealant compositions were at least >99% effective in preventing the spread of the microorganisms into the wound site. EXAMPLE 19 In Vivo Bacteria Immobilization A total of 60 healthy volunteers (29 females and 31 males) were recruited to evaluate the in vivo bacteria immobilization of a microbial sealant composition comprising 20% butyl cyanoacrylate and 80% octyl cyanoacrylate. The study included a 14-day pretreatment washout period for stabilization of skin bacteria flora. During the washout period, subjects refrained from using any topical antimicrobials, systemic antibiotics, medical soaps, lotions, shampoos, etc, for at least two weeks before the evaluation and throughout the study. The tested area consisted of the right inguinal region. Hair was removed using a sterile disposable clipper device. A sterile drape was used to isolate the inguinal area from the rest of the body and then a surgical marker was used to draw four different 1 inch squares separated by 1 inch of normal skin in which the microbial sealant composition was applied. Using sterile gloves the products were applied onto the skin in its designated areas and allowed to dry. Sterile gauze was placed over the test area to avoid subsequent contamination. Swabbed samples from skin were collected at 15 minutes, 4 hours and 24 hours after the initial application of the microbial sealant composition. The sample collection procedure was performed using a sterile technique including sterile gloves, sterile microbial sealants, surgical masks and hats. After the sampling was completed the entire contents of the tube was poured carefully onto a 1 mL Petrifilm aerobic plate (plate count agar) and the plates were incubated for 48 hours at 30° C. 3M™ Petrifilm™ plate was used to quantify colony counts. At 15 minutes, the absolute log reduction was 5.568 for the disclosed microbial sealant composition. The absolute log reduction of bacteria for the disclosed microbial sealant composition is 4.299 and 3.33 at 4 hours and 24 hours, respectively. EXAMPLE 20 In Vitro Chromosomal Aberration Study in Mammalian Cells A chromosomal aberration study was conducted to determine whether an extract of the microbial sealant drape composition wound cause clastogenic changes in Chinese Hamster Ovary (CHO). A glass rod was sterilized with 70% isopropyl alcohol and allowed to air dry. The glass rod was then coated (4 cm) with a microbial sealant composition comprising 20% butyl cyanoacrylate and 80% octyl cyanoacrylate and allowed to air dry for at least 1 minute prior to placing the coated rod in the extraction container. A single preparation was extracted with DMSO with agitation at 37° C. for 72 hours. Following extraction, the DMSO extract was diluted with McCoy's 5A medium to a final concentration of 25% prior to testing. Aveclor 1254=induced rat liver (S9 homogenate) was used as metabolic activation. The S9 homogenate is prepared from male, Sprague Dawley rats. An uncoated glass rod was subjected to the same extraction conditions to serve as a negative control. A known direct acting genotoxic compound, Mitomycin C (MMC), was used as a positive control to demonstrate that CHO cells were sensitive to mutagens in the absence of metabolic activation. The microbial sealant composition extract, negative control, and positive control were tested in triplicate. For the assays conducted without metabolic activation, the growth medium in each of three test culture flasks was replaced with 10 ml of the prepared extracts. For the assay conducted with metabolic activation, the test samples were supplemented with isocitrate dehydrogenase (NADP+) at 60 μl/ml and S9 at 20 μl/ml. After 18 hours of incubation at 37° C. in the presence of CO 2 , the medium was decanted and the cultures were rinsed twice with 4-6 ml of calcium magnesium free phosphate buffered saline (CMF-PBS). The flasks were incubated for an additional 2 hours at 37° C. After harvesting, slides of the cells were prepared, stained with Giemsa, and examined microscopically for chromosomal aberrations at 100× magnification. Under the conditions of this assay, the DMSO test extract of the disclosed microbial sealant composition was not considered genotoxic to Chinese Hamster Ovary cells in the absence of S9 metabolic activation. The prepared McCoy's extract was not considered genotoxic to Chinese Hamster Ovary cells in the presence or absence of S9 metabolic activation. The positive and negative controls performed as expected. EXAMPLE 21 Resistance to Impact Penetration The resistance of a microbial sealant drape composition comprising 20% butyl cyanoacrylate and 80% octyl cyanoacrylate to the penetration of water by impact was evaluated by following the American Association of Textile Chemists and Colorists (AATCC) test method. Test sample films of the microbial sealant composition were made that measured 178×230 mm. The samples and the blotting paper were conditioned in an atmosphere of 65±2% relative humidity (RH) at 21±1° C. for 4 hours before testing. After clamping the film onto an inclined stand, a standard blotter 152×230 mm was weighed and inserted beneath the test sample. A 500±10 ml volume of distilled water at 27±1° C. was poured into a funnel of the tester and allowed to spray onto the test sample of the microbial sealant composition. After the spraying, the test sample was carefully lifted, the blotter removed and reweighed to determine the amount of water that penetrated the film during the test. The mean value for the microbial sealant composition was 0.03 grams. Under the same conditions a commercial microbial sealant film comprised of 100% butyl cyanoacrylate displayed a mean value of 0.07 grams. EXAMPLE 22 Sealant Film Integrity Over Time The integrity (degradation over time) of a microbial sealant composition comprising 20% butyl cyanoacrylate and 80% octyl cyanoacrylate was evaluated following topical application to the skin of three pigs and compared to another microbial sealant product. The pigs were restrained in a sling for up to 30 minutes during the application procedures. To reduce possible stress at being restrained in the sling, the pigs were initially conditioned to the sling over the course of 3 days prior to commencement of the application procedures. The day prior to treatment, each pig was weighed and placed in a sling. The hair on the dorso-lateral area was removed. The depilated skin was washed with povidone iodine scrub, rinsed well with water, and dried. On the day of the application procedure, each pig was placed in a sling. The depilated area of the back was scrubbed with povidone iodine, wiped with 70% isopropyl alcohol and painted with 10% povidone iodine antiseptic. The microbial sealant composition of the present invention and another commercial drape were applied to four sites approximately 1×2 inches in area. The applied drape film at each application site was evaluated for degradation at approximately 8 hours after application, and 1, 2, 3, 4, 6, 8, 10, 12, 14, and 16 days after application. Degradation of both microbial sealant films was evident by the first observation interval (8 hours after application). At this time, 2 out of 12 test sites with the microbial sealant film of the present invention remained intact and 5 out of 12 sites with the commercial film were intact. When the study ended on day 16, the microbial sealant film of the present invention was partially present in only 2 of the 12 sites, while the commercial film was absent from all 12 sites.

1a

This is a continuation of copending application Ser. No. 07/636,802 filed on Jan. 2, 1991, now abandoned, which in turn is a continuation-in-part of Ser. No. 07/501,992 filed on Mar. 29, 1990, now issued. BACKGROUND OF THE INVENTION This invention relates to a toothbrush and more particularly to a toothbrush having its bristles so arranged as to be effective for the removal of plaque from teeth with manual brushing. The prior art is aware of a number of toothbrush constructions. However none of the latter exhibits a tuft arrangement which performs several tooth and gumline cleaning functions regardless of the style or technique of brushing. A number of toothbrush manufacturers set out specific brushing techniques on their brush containers. If, however, a purchaser does not pay attention to them, or forgets these techniques, then less than optimum teeth cleaning results. SUMMARY OF THE INVENTION According to the practice of this invention, the tufts are arranged along the brush head in distinct groups, and preferably in rows, the rows running generally transversely of the longitudinal axis of the head. Bristles of the individual tufts (each tuft comprising a distinct packet of bristles) are anchored into two types of cavities. Round cavities are generously spaced so as to allow independent and uninhibited movement of each tuft of bristles. Polygonal (typically quadrangular) cavities are closely spaced transversely so as to create continuous linear rows of bristle tips. These polygonal cavities may have rounded or angular corners. Densely spaced tufts typical of prior constructions, tend to move tangentially and thus push each other along as they sweep across tooth surfaces. Generously spaced tufts of this invention move erratically as they negotiate the often irregular contours of tooth crevices. Each of a first group of tufts is anchored into generally round cavities and includes a center or middle tuft and a pair of laterally outermost tufts, each of which are substantially perpendicular to the surface of the brush head. This group defines interproximal bristles which reach into crevices between teeth. The tufts of this group allow for individual bristle fibers to penetrate tight interproximal spaces and create fans of bristle tips as they are wiped across tooth surfaces. By generally round is meant circular in shape and nearly circular such as elliptical. Each of a second group of tufts is anchored into polygonal cavities, preferably quadrangular, and most preferably rectangular. There are preferably six or seven tufts, although five or eight tufts can also be used. Each tuft of the second group extends substantially perpendicularly to the surface of the brush head. Each of a third group of tufts is anchored into generally round cavities and this group includes approximately fourteen tufts positioned along the perimeter of the brush head. Approximately six outermost tufts on each side of the center line of the head tilt laterally outwardly toward the nearest side of the brush head. Two forwardmost tufts (towards the free end of the head) tilt laterally, toward their respective side of the brush head, and also tilt forwardly. These forwardmost tufts which tilt forwardly and laterally may also be considered as a fourth group or as a subgroup of the third group. The perimeter tufts of this group are angled outward from the center line of the brush head so that they project into the gingival marginal area at the base of the crowns of the teeth. This action occurs as downward force is applied to the brush head and is not dependent upon a non-perpendicular orientation of the brush head relative to the tooth surfaces. These perimeter tufts of bristles are angled so that they are unable to structurally support one another as downward and horizontal force is applied by the user. Conventional, perpendicularly oriented bristle tufts tend to act as a series of columns and thus support suspended bristles as they pass over embrasures. The minimized overall compression strength afforded by this angled configuration allows individual tufts of bristles to penetrate embrasures, sub-gingival and interproximal spaces without being inhibited from doing so by surrounding bristle tufts. Angled tufts move in the direction of their angle. As downward and horizontal force is applied to the brush head, tufts of bristles skid across tooth surfaces generally in the direction dictated by the angle of the tuft hole in which the bristles are anchored to the brush head rather than simply curl back in the opposite direction in which they are pushed. The construction of this invention is to integrate multi-directional motion of bristles during unidirectional actuation of the brush. When forced into the direction of their angle, bristles will spring out of crevasses as stresses are exceeded to contain them in place. This dynamic action will tend to fling plaque out of interproximal spaces. Conventional devices tend to pack plaque into spaces as bristle tufts sweep over embrasures. The weak flexure strength of generously spaced individual bristle tufts allows for the reduction of bristle height without causing the sensation of increased bristle stiffness. Conventional brushes trimmed to the shorter height are perceptibly stiffer and tend to cause trauma to the mucosa. Minimized bristle height allows for greater clearance (and thus enhance reach to the rear molars) between the buccal surfaces of the teeth and the mucosal lining. Angled tufts of bristles will assume varying heights as they are deformed, yet will be uniform in height when not in use. Angled bristles will project above the tips of straight bristles as the former are forced into a perpendicular orientation during use. This effect, caused by the greater length of the hypotenuse of a triangle, allows for the angled tufts to reach deeply into interproximal and gingival marginal areas as perpendicular orientation is assumed. Generally round tufts of bristles are preferably trimmed to a taller height than polygonal tufts. This configuration allows for the round tufts of bristles to penetrate interproximal spaces before tooth surfaces contact the bristle tips of polygonal tufts. Compact linear rows of shorter polygonal tufts uniformly sweep plaque off tooth surfaces without inhibiting adjacent round tufts of bristles from penetrating embrasures. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a partial perspective view of a toothbrush formed in accordance with a first embodiment of this invention. FIG. 2 is a partial perspective view of a toothbrush formed in accordance with a second embodiment of this invention. FIGS. 3 to 6 are plan views of the toothbrush of FIG. 1 and illustrate, with respective FIGS. 3a to 6a, the function of the several groups of tufts and their contact with teeth T and gums denoted as G. FIG. 7 is a top plan view of a modified version of the toothbrush of FIG. 2. FIG. 8 is a top plan view of a modification of the toothbrush of FIG. 7. DETAILED DESCRIPTION OF THE INVENTION Referring now to FIG. 1, the numeral 10 denotes generally the toothbrush of this invention and includes a head 12 having a flat upper surface 14 and a longitudinal axis 16. The head is, typically, integrally joined to a handle 20, with head longitudinal axis 16 not necessarily coincident (as shown) with the longitudinal axis of handle 20, only a portion of the latter being shown. The handle construction forms no part of the invention. Both head 12 and handle 20 may be formed of suitable plastic material such as any of those commonly used. Any of a first group of polygonal tufts is denoted as 24, with a single wide tuft 25 defining each group, each single wide tuft having its longitudinal axis oriented transversely to axis 16. It will be noted that the bristles in tufts 25 are shorter than those of the bristles in the other groups. All of the groups 24 are parallel to each other and are orthogonal to the axis 16. Tuft 25 is termed a bristle bar or bristle bar of tufts. A second group of generally round tufts is denoted as 26, each group 26 also oriented transversely to axis 16. The two endmost tufts of row 26 are each denoted as 30, with each such tuft tilting laterally or sideways toward a respective side of head 12, (orthogonally to axis 16) by about 12 degrees with respect to the vertical. The remaining three spaced apart tufts in each group 26, each denoted as 32 and termed interproximal bristles, are substantially perpendicular to surface 14, i.e., vertical. Each tuft 30 is laterally spaced from its next adjacent tuft 32. Tufts 30 and 32 are preferably of the same diameter. The bristles in tufts 30 are termed gumline bristles. Each group 26 thus contains both interproximal and gumline bristles. The groups of round tufts are preferably in rows transverse to the longitudinal axis of head 12. A third group 34 is defined by two laterally spaced generally round tufts 36. Each tuft 36 tilts laterally toward its respective side of the brush head by about 30 degrees. Each tuft 36 also tilts with respect to a plane which contains it, about 14 degrees to the vertical. Thus each tuft 36 tilts both laterally and forwardly toward the free end of the head. Tufts 36 are termed leading tip bristles. This group 34 is preferably comprised of two or more tufts. Referring now to FIG. 2 of the drawings, the construction is the same as that shown in FIG. 1, except that the wide bristle bar tufts 25, each of which defines a row 24, are each replaced by a row 240 defined by individual round tufts 242. Rows 240 of tufts 242, as the tufts in the other rows 26, 24 and 34 of FIG. 1, are aligned transversely to axis 16 and are longitudinally spaced therealong. The construction of rows 24 of FIG. 1 entails forming relatively wide transverse grooves in head 12 for receiving the bottom ends of the bristles which define each bristle bar tuft 25. This can be done manually. If currently available automated machinery is used to form such wide grooves, certain problems arise in filling the grooves and in maintaining the bristles in each bristle bar at their desired perpendicular relation to head surface 14. To overcome these problems, transverse rows each of closely spaced generally round holes are formed on surface 14, instead of a wide groove, as shown in FIG. 2. Individual rounded tufts 242 are then, by automatic machinery currently available, inserted and fixed into these holes. The result yields rows 240 nearly identical to rows 24, with individual tufts 242 in close laterally spaced relation to each other. It will be observed that the arrangement of rows in both embodiments is such that rows 24 and 26 (as well as rows 240 and 26) alternate along axis 16, except that two rows 26 are next to row 34. Thus, there are at this region of the head two rows 26 adjacent each other as measured along longitudinal axis 16 of head 12. The tufts of rows 26 are preferably each of the same height and, as noted above, their height as measured vertically is greater than that of the tufts of rows 24. Typically, the height of the bristles in first group 24 is about 8.5 mm, while the height (as measured vertically) of the bristles of the tufts in the second and third groups 26 and 34 is typically about 10.5 mm. The longest tufts are those in group 34, with the next longest being tufts 30. The vertical height, however, of tufts 30 and 34 is the same as measured from the head surface 14. The spacing between rows 24 (240) 26, 30, 32 and 34 is typically about 0.09 inches, as measured at the bottom of the tufts. In the embodiment of FIG. 1, the lateral spacing between tufts 32 is about 0.06 inches and the lateral spacing between tufts 30 of any group 26 is about 0.28 inches. The length of single tufts 25 is about 0.34 inches and their thickness is about 0.06 inches. The lateral spacing between tufts 36 is about 0.070 inches. The base diameter of tufts 36 and 30 is about 0.050 inches to about 0.060 inches. The base diameter of tufts 32 is about 0.040 inches. In the embodiment of FIG. 2, the lateral spacing between tufts 32 is about 0.065 inches and the lateral spacing between tufts 30 of any row 26 is about 0.312 inches. The lateral spacing between tufts 242 is about 0.065 inches and that between tufts 36 is typically about 0.092 inches. The base diameter of all of the tufts is about 0.050 inches to about 0.060 inches. Referring to FIGS. 3 to 6 and their respective counterparts FIGS. 3a to 6a, the specific cleaning function of the tufts of the embodiment of FIG. 1 is illustrated. The several groups are highlighted by vertical hatching at FIGS. 3 to 6. In this description, the tufts are described and grouped as to the functions they perform, while the previous description has described the tufts solely as to the several rows they define. At FIGS. 3 and 3a, bristle bars 25 clean the broad surfaces of the teeth with centrally located bristle packs that maximize the cleaning contact to the teeth. The shorter length of these bristles brings them into contact with the surfaces of the teeth as the longer interproximal bristles 32 (as shown in FIG. 4 and 4a) enter the crevices between the teeth. Tufts 32 and 36 are omitted from FIG. 3a for purposes of clarity. Conventional toothbrushes do not concentrate bristle density or tuft density to such a degree, with the result that less cleaning than is desirable is accomplished on the broad tooth surfaces. At FIGS. 4 and 4a, the long, centrally located interproximal tufts of bristles 32 reach into the crevices between teeth. These bristle tufts are spaced to allow deep cleaning access. The specific placement pattern of these tufts allows for dynamic and independent cleaning action. Convention toothbrushes have bristles of the same length and density that tend to structurally support each other, acting as a single block and preventing the dynamic, independent action required for multi-task cleaning. At FIG. 5 and 5a, long flexible bristles 30 line each side of the brush head 12 and are angled outwardly to gently sweep plaque from the teeth at the gumline and from in between teeth. The intentional outward angle results in a soft, controlled bristle action aimed at the gumline. Conventional toothbrushes have vertical bristles whose flexing is not controlled or directed towards the gumline. Conventional vertical bristles can cause damage to the soft gum tissue. At FIGS. 6 and 6a, leading tip tufts of bristles 36 at the tip of the brush head are angled forward to ensure that the cleaning action reaches the teeth at the back of the mouth and cleans in between teeth. Additionally, they clean the lingual surfaces and the sulcus areas of the front teeth. Vertical bristles limit the access of conventional toothbrushes to the back of the mouth where plaque continues to accumulate. There are thus four functional groups of tufts in head 12. There are the bristle bar group defined by tufts 25, 242 and 246 for cleaning broad surfaces of the exposed sides of teeth, the interproximal bristle group defined by tufts 32 for cleaning the crevices between teeth, the gumline bristle group defined by tufts 30 for cleaning teeth at the gumline, and the leading tip bristles group defined by tufts 36 which ensures cleaning of teeth in the back of the mouth. In the embodiment of FIG. 7, the five generally round tufts 242 in each of rows 240 of FIG. 2 are replaced by a greater number of quadrangular tufts 246 which are preferably rectangular. In all other respects, the bristle/tuft configuration and dimensions are the same. Each quadrangular tuft preferably should be of about the same area as the round holes in head 12 which receive generally round tufts 242 of FIG. 2. These tufts can also be square in shape but when not square in shape, the smaller dimension of each tuft 246 preferably is along each row 240, i.e., is perpendicular to axis 16. The change from a generally round to a quadrangular tuft cross section, with these dimensions of each quadrangle, permits seven quadrangular tufts 246 in each row instead of five round tufts 242, with only slight row lengthening. The cross-sectional area of each round tuft 242 is the same as the cross-sectional area of each quadrangular tuft 246, but the tuft dimension along row 240 is smaller with a rectangular shaped tuft, the preferred shape, hence the greater number of bristles in a row 240 of rectangular tufts. Another advantage of the rectangular tuft shape is that it more nearly approximates the bristle bars 25 of FIG. 1 in the number of individual bristles in each row 240. Namely, the number of bristles in each row 240 of FIG. 7 is greater than the number of bristles in each row 240 of FIG. 2. In the embodiment of FIG. 7, the lateral spacing between tufts 32 is about 0.65 inches and the lateral spacing between tufts 30 is about 0.312 inches. The lateral spacing between tufts 246 is about 0.054 inches and that between tufts 36 is about 0.092 inches. The shortest dimension of each rectangular tuft 246 is about 0.039 inches and its longest dimension is about 0.05 inches. In FIG. 7, the longest dimension of each rectangular tuft 246 is parallel to axis 16. If desired, rectangular tufts 246 of any row 240, or of all the rows 240, may be rotated 90 degrees so that the longest dimension of each rectangular tuft is perpendicular to axis 16. To preserve required intertuft spacing along any row 240, it may be necessary to omit one of the tufts 246, so that any row 240 would contain only six of the rectangular tufts. Referring now to the embodiment of FIG. 8, the construction is similar to that shown in FIG. 7, also utilizing rectangular polygonal tufts. The differences relate to the tuft sizes and spacing, to be later given, and to those tufts at the free end of the head, i.e., remote from the handle. In the embodiments previously described, two tufts 36 are located nearest the head free end, with each tuft tilted both forwardly (away from the handle) and laterally outwardly, away from the head center along axis 16. In the FIG. 8 embodiment, the two forwardmost tufts 36 are replaced by three tufts 37 arranged in a single transverse row 250, the latter parallel to transverse rows 240. Each tuft 27 is of the same size. The middle tuft is centrally located on the tuft head 12, coincident with axis 16, and is perpendicular to the brush head. The two outermost tufts 37 tilt laterally outwardly at about 12 degrees from the vertical. These tufts can also tilt forwardly as do tufts 36 with regard to the embodiment of FIG. 7. The tufts 37 each lie in a plane transverse to axis 16. Tufts 37 perform a function similar to that of tufts 36. In the embodiment of FIG. 8, the longitudinal spacing (as measured along axis 16) between the transverse rows of tufts is 0.10 inch. The spacing between the tuft receiving openings in the brush head, as measured along each transverse row, is about 0.015 inch. The diameter of the brush head openings which receives the round tufts is about 0.06 inch. The shortest dimension of each rectangular tuft 248 is about 0.047 inch, while the longest dimension is about 0.060 inch. The rectangular tufts of FIG. 8 are each denoted as 246. In FIG. 8, as in the embodiment of FIG. 7, the longest dimension of each rectangular tuft is parallel to axis 16. If desired, rectangular tufts 248 of any row 240, or of all the rows 240, may be rotated 90 degrees, so that the longest dimension of each rectangular tuft 248 is perpendicular to axis 16. To preserve required intertuft spacing along any row 240, it may be necessary to omit one of the tufts 248. The head of the embodiment of FIG. 8 is about 0.1 inch longer than the head of the embodiment of FIG. 7, while its width is about 0.030 inches wider. The diameter of tufts 32 and 37 may be the same or may differ. Preferably, they are of the same diameter.

1a

FIELD OF THE INVENTION [0001] The present invention relates generally to medical equipment. More particularly, the present invention relates to intubation aides, such as forceps, used to guide tubes during insertion into a patient's body. BACKGROUND OF THE INVENTION [0002] Medical professionals have used various tools and implements in their treatment of patients, both human and animal, since the beginning of the profession. (For ease of reference, patients hereinafter will be discussed as human patients. It is understood that the invention described herein could be used on any animal.) Various procedures involve insertion of a catheter into a patient, including oral or nasal endotracheal intubation, during which a medical professional inserts a nasal or oral endotracheal tube into the patient's trachea to assist with the patient's ventilation. [0003] In order to assist with endotracheal intubation, an implement, such as forceps, is used by the medical professional to guide and/or direct the catheter into the proper place. Another implement, called a laryngoscope, is used during nasal and oral endotracheal intubation to secure the patient's tongue and lift the mandible, i.e. jaw, to expose the vocal cords. When the patient's head is tilted back, as is done during the intubation procedure, and the tongue and jaw are stabilized and properly secured, the medical professional performing the intubation will have an unobstructed view of the patient's vocal cords, provided there are no foreign objects or fluids in the patient's mouth. However, when the medical professional inserts any of the currently-available guiding forceps into the patient's mouth, the medical professional's view is severely obstructed by his or her hand and by the forceps. Also, the currently-available forceps do not grasp and control the tube adequately. This makes the process of endoctracheal intubation more difficult and more time-consuming, which could mean the difference between life and death for a patient that requires assistance with ventilation. [0004] One example of currently-available forceps is described in U.S. Pat. No. 3,316,913 to Swenson. The Swenson patent discloses locking catheter-guiding forceps that have a slight bend in the handles. When closed, the ends of the forceps define opposed gripping surfaces that are used to guide insertion of a catheter. The angle of the bend in the handles makes using the forceps disclosed in the Swenson patent difficult because the medical professional's hand will block his or her view into the patient's body. [0005] U.S. Pat. No. 4,552,143 to Lottick, U.S. Pat. No. 5,797,919 to Brinson, U.S. Pat. No. 5,591,203 to Fahy, and U.S. Pat. No. 5,476,479 to Green all disclose medical implements that have an end that, when the implements' handles are closed, define a circular opening through which various items can be passed. These implements are all lacking, however, in that they do not allow the medical professional to have clear view and access to difficult areas to reach in a patient's body, such as during nasal or oral endotracheal intubation. [0006] In endotracheal intubation situations, a key problem with many currently-available medical forceps is that the medical professional is required to grip or grab the nasally or orally-inserted catheter tube in the back of the pharynx and try to place the tube through the patient's vocal cords by frequently gripping and re-gripping the lubricated catheter tube, which is also coated with nasal and oral secretions and possibly blood in a traumatic situation. These forceps frequently have serrated edges or teeth, which assist in gripping the catheter tube but also can snag or catch on the soft tissues inside the patient's mouth and throat and damage the patient's vocal cords. Even if the patient is not harmed, these sharp edges on the forceps can rupture the balloon on the lower end of the catheter, which must be inflated once the catheter is inserted past the patient's vocal cords to create an air-tight seal and allow for ventilation. [0007] Therefore, there exists a need to provide catheter-guiding forceps that allow a medical professional to have easy access to difficult-to-reach areas of a patient's body, such as in an oral or nasal endotracheal intubation, while simultaneously allowing the medical professional to have an unobstructed or virtually unobstructed view of the area in the patient's body in which the medical professional is working, such as the patient's vocal cords. Further, there exists a need to provide forceps that allow a catheter tube to easily pass through the forceps instead of requiring frequent re-gripping of the slippery catheter tube. SUMMARY OF THE INVENTION [0008] Generally, the present invention comprises forceps with a pair of scissor-like handles that are pivotally connected to each other and that continue past the pivot to form a pair of arms. There are at least two key bends in the handles immediately before the pivot, which allow the medical professional to place the distal, guiding end of the forceps in the correct place within the pharynx while simultaneously permitting good visual contact with the area of concern, particularly the patient's vocal cords, because the medical professional's hand holding the forceps is not in his or her line of sight of the area through which the tube is to be placed while using the forceps. During endotracheal intubation, the medical professional places the forceps into the area of the patient's oropharynx (i.e., the back of the throat). Then, the catheter tube can be guided through the forceps and past the patient's vocal cords through the glottis (i.e., the aperture through the vocal cords), where ventilation is maintained. The medical professional does not have to grip and re-grip the catheter tube during this process, eliminating the risk of harm to the patient and damage to the catheter tube that re-gripping may cause. Further, this invention does not have sharp edges or ridges to catch or snag either the patient's tissue or the balloon-like portion associated with the catheter tube. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a left side elevational view of a prior art medical implement. [0010] FIG. 2 is a left side elevational view of the implement of the present invention with the arms closed. [0011] FIG. 3 is a left side elevational view of the implement of FIG. 2 with the arms open. [0012] FIG. 4 is a top plan view of FIG. 2 . [0013] FIG. 5 is a right side elevational view of FIG. 2 . [0014] FIG. 6 is a left side elevational view of an alternative embodiment of the present invention. [0015] FIG. 7 is a side cutaway view illustrating the use of the present invention in a patient. [0016] FIG. 8 is a diagrammatic representation showing the use of the present invention in a patient. [0017] FIG. 9 is a plan view showing the invention being used in a patient. [0018] FIG. 10 is a left side elevational view of a further a further embodiment of the invention. [0019] FIG. 11 is a left side elevational view of a still further embodiment of the invention. [0020] FIG. 12 is an enlarged detail of the distal end of the device of the embodiment of FIG. 11 . [0021] FIG. 13 is plan view of the distal end shown in FIG. 12 . DETAILED DESCRIPTION OF THE INVENTION [0022] A catheter guiding device 1 that currently exists in the art is depicted in FIG. 1 . A pair of handles 5 , 10 each defines an aperture 2 , 3 for a user to insert a finger and thumb. The handles 5 , 10 are integrally connected to a pair of arms 15 , 20 . The handle 5 and arm 15 is pivotally connected to the handle 10 and arm 20 through a pivot 50 . Each arm 15 , 20 has an end 30 , 35 , respectively, that is D-shaped with parallel, sharp serrations on the interior surfaces. When using this device to insert a catheter into a patient, a medical professional will insert his or her fingers into the apertures 2 , 3 and open the handles 5 , 10 , which correspondingly open the arms 15 , 20 . The health care professional will then close the handles 5 , 10 , accordingly closing the arms 15 , 20 , so that the ends 30 , 35 grip the catheter. The device 1 is then used to push the catheter through the patient's vocal cords to allow ventilation or to insert the catheter into any other part of the patient's body as deemed necessary by the medical professional. [0023] The device 1 does not allow for guiding of the catheter because the ends 30 , 35 must grip the catheter and are used to push the catheter a short distance, which is repeated numerous times so as to advance the catheter. Further, because of the presence of his or hand due to the bent section 60 of the device 1 , the medical professional using the device 1 will be blocked from viewing of the patient's vocal cords or other body part into which the catheter will be inserted. [0024] The present invention can be more fully understood with reference to FIGS. 2-11 , in which like reference numerals designate like items. FIG. 2 depicts the forceps 101 , which is an improvement over the device 1 currently in use. The pair of handles 105 , 110 of the forceps 101 each defines a gripping section 102 , 103 , respectively, upon which the medical professional can place his or her fingers to use the forceps 101 . Gripping sections 102 , 103 can be of any shape. The shape shown is only illustrative. The handles 105 , 110 are integrally connected to a pair of arms, 115 , 120 . The handle 105 and arm 115 is pivotally connected to the handle 110 and arm 120 at a pivot 150 . Each arm 115 , 120 has an end 130 , 135 , respectively, that is substantially semicircular in shape; however, the shape of the ends 130 , 135 may, within the scope of the invention, be any shape that would allow the ends 130 , 135 to form a guide when in the closed position such that a catheter may be easily passed therethrough. When the arms 115 , 120 are in the closed position as shown in FIGS. 2 and 4 - 7 , the ends 130 , 135 together form a hollow guide adapted to receive and guide the catheter so that the catheter can be advanced through the patient's vocal cords. In the closed position, the interior surface of the hollow guide formed by the ends 130 , 135 is preferably slightly larger than 8 mm across, which is slightly larger than the diameter of a standard-sized catheter used for medical purposes today. It is understood that the size of the guide formed by the ends 130 , 135 may be varied within the scope of this invention depending upon the diameter of the catheter, including but not limited to catheters that are used in infant patients. All that is required is that the catheter be able to be slid or translated within the guide when the guide is in the closed position. [0025] When using this device to insert a catheter into a patient, a health care professional will insert his or her fingers into the apertures 102 , 103 and open the handles 105 , 110 , which correspondingly open the arms 115 , 120 . FIG. 3 depicts the forceps 101 in the open position. The catheter is then inserted through the circular aperture defined by the ends 130 , 135 of the arms 115 , 120 . The arms 115 , 120 are positioned so that the guide is placed in registry with the patient's glottis (the opening in the vocal cords) so that the catheter can be accurately inserted into the proper location in the patient's body, such as through the patient's vocal cords. The first bend 140 and the second bend 145 allow the medical professional to have an unobstructed view of the patient's vocal cords or other body part into which the catheter is to be inserted. This allows for faster and more accurate insertion of the catheter, without the risk of harm to the patient or damage to the catheter that arises when the medical professional must grip and re-grip the catheter as with currently-available devices, such as the device depicted in FIG. 1 . [0026] FIG. 4 depicts the forceps shown in FIG. 2 from the top. The first bend 140 , second bend 145 , and third bend 147 are clearly visible from this view. The combination of the first bend 140 and second bend 145 provides the medical professional with an unobstructed view of the patient's vocal cords because the user's hand that holds the forceps is off to the side of the mouth while the guide is in registry with the glottis. The third bend 147 contributes to the unobstructed view of the patient's vocal cords. The first bend 140 is bent about an axis A to create an obtuse angle. The second bend 145 is bent about an axis B to create an obtuse angle that is preferably, but not necessarily, approximately 120°. The third bend 147 is bent about an axis C to create an obtuse angle that is preferably, but not necessarily, approximately 150°. [0027] FIG. 5 is a right side view of the forceps shown in FIG. 2 . The arms 115 , 120 and the ends 130 , 135 are smooth, having no sharp edges or teeth that could harm a patient's tissue or damage the balloon portion of a catheter. [0028] An alternative embodiment of the forceps 201 is depicted in FIG. 6 . The pair of handles 205 , 210 of the forceps 201 each defines an aperture 202 , 203 through which the medical professional can insert his or her fingers to use the forceps 201 . The handles 205 , 210 are integrally connected to a pair of arms 215 , 220 . The handle 205 and arm 215 is pivotally connected to the handle 210 and arm 220 at a pivot 250 . Each arm 215 , 220 has an end 230 , 235 , respectively, that is substantially semicircular in shape; however, the shape of the ends 230 , 235 may, within the scope of the invention, be any shape that would allow the ends 230 , 235 to form a guide when in the closed position such that a catheter may be easily passed therethrough. When the arms 215 , 220 are in the closed position as shown in FIG. 6 , the ends 230 , 235 together form a hollow guide adapted to receive and guide the catheter so that the catheter can be advanced into the patient's glottis. In the preferred embodiment, when the arms are in their closed position, the interior surface of the hollow guide formed by the ends 230 , 235 is preferably slightly larger than 8 mm across, which is slightly larger than the diameter of a standard-sized catheter used for medical purposes today. It is understood that the size of the guide formed by the ends 230 , 235 may be varied within the scope of this invention depending upon the diameter of the catheter, including but not limited to catheters that are used in infant patients. [0029] The forceps 201 has a first bend 240 and a second bend 245 that together allow the medical professional to have an unobstructed view of the patient's glottis and vocal cords or other body part into which the catheter is to be inserted. The difference between the forceps 101 and the forceps 201 is that the forceps 201 has a fourth bend 280 located immediately before the ends 230 , 235 . The fourth bend 280 rotates the ends 230 , 235 approximately fifteen degrees clockwise from their standard position, although a greater or lesser magnitude of bend may be desirable as will occur to the person of skill in the art. Also, the bend 280 may be as shown (acute) or may rotate the ends 230 , 235 in the opposite direction, creating an obtuse angle. The angle of insertion of a catheter through the ends 230 , 235 is changed by the fourth bend 280 , allowing for an easier insertion in patients that have a shorter neck, such as children or small adults. It is understood that the degree of the angle of the fourth bend 280 may vary according to the needs of a particular situation within the scope of this invention. [0030] FIGS. 7 through 9 illustrate the use of the forceps 101 and a laryngoscope 450 in a patient. Nasal endotracheal intubation is illustrated in FIG. 7 , wherein a ventilation tube 400 is inserted into the patient's nose and passed through the patient's sinus cavity into the back of the patient's throat. A laryngoscope 450 is used to secure the patient's tongue and provide light to the patient's throat. As the medical professional holds the forceps 101 in registry with the patient's glottis 500 , a medical assistant, such as a nurse, will advance the ventilation tube 400 through the ends 130 , 135 of the forceps 101 and through the patient's glottis 500 . After being properly located, the balloon portion 420 of the ventilation tube 400 is inflated to secure a seal and allow for proper ventilation. [0031] An alternative embodiment of the forceps 601 is depicted in FIG. 10 . The pair of handles 605 , 610 of the forceps 601 each defines an aperture 602 , 603 through which a medical professional can insert his or her fingers to use the forceps 601 . The handles 605 , 610 are integrally connected to a pair of arms 615 , 620 , respectively. The handle 605 and arm 615 is pivotally connected to the handle 610 and arm 620 at pivot 650 . Each arm 615 , 620 has an end 630 , 635 , respectively, that is substantially shaped as half of a cone (or, alternatively, as half of a cylinder); when the arms 615 , 620 are in the closed position as shown in FIG. 10 , the ends 630 , 635 together form a cone-shaped (or cylindrically-shaped) guide adapted to receive and guide a catheter so that the catheter can be advanced into the patient's glottis. The diameter of the cone-shaped ends 630 , 635 , when closed, is preferably slightly larger than 8 mm across at its narrowest point. The portion of the ends 630 , 635 that is closer to the handles 605 , 610 preferably has a diameter larger than 8 mm. In the closed position, the interior surface of the hollow guide formed by the cone-shaped ends 630 , 635 acts as a funnel of sorts to allow the medical professional to more easily guide the end of a catheter through the cone-shaped ends 630 , 635 . It is understood that the size of the guide formed by the ends 630 , 635 may be varied within the scope of this invention depending upon the diameter of the catheter, including but not limited to catheters that are used in infant patients. The forceps 601 has a first bend 640 and a second bend 645 that together allow the medical professional to have an unobstructed view of the patient's glottis and vocal cords or other part into which the catheter is to be inserted. [0032] Another alternative embodiment of the forceps 701 is depicted in FIGS. 11-13 . The pair of handles 705 , 710 of the forceps 701 each defines an aperture 702 , 703 through which the medical professional can insert his or her fingers to use the forceps 701 . The handles 705 , 710 are integrally connected to a pair of arms 715 , 720 , respectively. The handle 705 and arm 715 is pivotally connected to the handle 710 and arm 720 at a pivot 750 . Each arm 715 , 720 has an end 730 , 735 , respectively, that is substantially semi-circular in shape. However, the shape of the ends 730 , 735 may, within the scope of the invention, be any shape that would allow the ends 730 , 735 to form a guide when in the closed position such that a catheter may be easily passed therethrough. When the arms 715 , 720 are in the closed position as shown in FIG. 11 , the ends 730 , 735 together form a hollow guide adapted to receive and guide the catheter so that the catheter can be advanced into the patient's glottis. In the closed position, the interior surface of the hollow guide formed by the ends 730 , 735 is preferably slightly larger than 8 mm across, which is slightly larger than the diameter of a standard-sized catheter used for medical purposes today. It is understood that the size of the guide formed by the ends 730 , 735 may be varied within the scope of this invention depending upon the diameter of the catheter, including but not limited to catheters that are used in infant patients. [0033] The forceps 701 has a first bend 740 and a second bend 745 that together allow the medical professional to have an unobstructed view of the patient's glottis and vocal cords or other body parts into which the catheter is to be inserted. Ends 730 , 735 are pivotally connected to arms 715 , 720 , respectively, by joints 775 , 780 . The joints 775 , 780 are preferably located about the same axis, as indicated in FIG. 12 . The ends 730 , 735 are permitted to rotate about the joints 775 , 780 to allow for immediate adaptation of the forceps 701 to the angle of insertion required by a patient's body. Any suitable means may be employed for releasably retaining the ends 730 , 735 in any desired angular position relative to arms 715 , 720 , such as opposed serrations or teeth (not shown). Other retention structure will be apparent to those of skill in the art. However, retention structure need not necessarily be used. In this manner, the medical professional using the forceps 701 is not required to change the instrument he or she is using upon discovering that a different angle of insertion of a catheter is required by a particular patient's anatomy. [0034] Benefits, other advantages, and solutions to problems have been described above with regard to specific embodiments of the present invention. However, the benefits, advantages, solutions to problems, and any element(s) that may cause or result in such benefits, advantages, or solutions to become more pronounced are not to be construed as a critical, required, or essential feature or element of any or all the claims. As used herein and in the appended claims, the terms “comprises,” “comprising” or any other variation thereof is intended to refer to a non-exclusive inclusion, such that a process, method, apparatus, or article of manufacture that comprises a list of elements does not include only those elements in the list, but may include other elements not expressly listed or inherent to such process, method, apparatus, or article of manufacture.

1a

CROSS-REFERENCE TO RELATED APPPLICATION [0001] Applicant claims the priority filing date of U.S. provisional patent application No. 61/768196 filed on Feb. 22, 2013. FEDERALLY SPONSORED RESEARCH [0002] Not Applicable SEQUENCE LISTING OR PROGRAM [0003] Not Applicable BACKGROUND [0004] Panels comprised of flexible or rigid material are used in a variety of settings where they are to be removed or exchanged at some future time. Examples where removable hanging panels are used include: shower and bathtub curtains; home decor; window treatments, and theatres. Panels, such as shower curtains and window treatments, are often hung from poles or rods using holes or loops in the panel. [0005] Methods of hanging the panels include sliding the rod through each of the holes or loops in the panel or using rings through each hole and around the rod. However, each of these methods require significant effort to hang and remove the panel: with the earlier method, the rod must be removed from its mounting hardware each time the panel is attached or removed: with the later method, every ring must be connected and disconnected each time the panel is attached or removed. These methods of hanging a panel make cleaning or exchanging panels an inconvenient and complicated procedure. [0006] For the foregoing reasons, there is a need for a panel system that can provide the ability to simply and quickly attach and remove a hanging panel. The solution is found in the present invention, which comprises a panel holder and panel joined together by a loop cache. When the panel holder is hung or attached to a rod, a panel can be simply and quickly attached or removed using the loop cache SUMMARY [0007] The present invention is directed to a panel system that satisfies this need to facilitate simple and quick attachment and removal of a hanging panel. The apparatus comprises a panel holder and panel, interconnected on by a complimentary loop cache on one edge of each panel. The loop cache is an interlocking fastener that can be incorporated into the panel construction and may include hooks, loops, clips, clasps, zippers, or magnets. [0008] The panel holder can be attached to a wall or ceiling using hardware typically used for hanging shower liners or curtains. Once the panel holder is attached, a panel can be quickly attached or removed and exchanged for another panel. The panel is attached to the panel holder by the loop cache. The loop cache is composed of an elongated two-part fastener, with one complimentary mating surface on the panel holder and panel mating edges. [0009] Hanging panels that are simple and quick to attach and remove facilitate cleaning tasks by making them more efficient. Shower curtains could be frequently removed for cleaning, significantly improving sanitation and time spend cleaning. When applied to curtain panels, the style and materials of window treatments could be changed with ease, allowing for easy cleaning and the ability to alter decor as seasons and style preferences change. Used in theatre settings, backdrops could be quickly changed between scenes. DRAWINGS [0010] FIG. 1 illustrates a front perspective view of an embodiment of shower curtain system embodying features of the present invention for a panel hanging system. [0011] FIG. 2 illustrates a front perspective view of an embodiment of window curtain system [0012] FIG. 3 illustrates a front perspective view of two panels embodying features of the present invention for a panel hanging system. [0013] FIG. 4A-B illustrates a top plan view of various loop cache fasteners embodying features of the present invention for a panel hanging system. [0014] FIG. 5A-B illustrates a top plan view of various loop cache tab locks embodying features of the present invention for a panel hanging system. [0015] FIG. 6A-B illustrates perspective views of an alternative loop cache embodying features of the present invention for a panel hanging system. [0016] FIG. 7A-B illustrates perspective views of an alternative loop cache tab lock embodying features of the present invention for a panel hanging system. [0017] FIG. 8 illustrates a top plan view of an alternative loop cache membrane embodying features of the present invention for a panel hanging system. DESCRIPTION [0018] As shown in FIGS. 1-8 , a panel hanging system comprises a panel holder 110 and at least one panel 130 joined together by a loop cache 120 . The loop cache 120 may further include a tab lock 124 to facilitate joining the two complimentary fastening surfaces of the loop cache 120 . A tab lock holder 116 may be incorporated into the tab lock 124 and loop cache 120 to prevent disengagement of the loop cache 120 and detachment of the panel 130 from the panel holder 110 . [0019] The panel holder 110 , illustrated in FIGS. 1-3 , provides a means for removably attaching a hanging panel without the need to remove any hardware normally used to hang a panel assembly. The panel holder 110 is shaped like a sheet with a top edge and bottom edge, and an outside and inside surface. The size of the Panel Holder 110 may vary depending on the intended use, but is generally rectangular in shape. The Panel Holder 110 can be hung from a rod or pole like those typically used for hanging a shower or window curtain. Holes 112 through the panel, near the top edge, facilitate connection of the Panel Holder 110 to a rod or pole by passing the rod through the holes in the Liner Curtain Holder 112 . Holes 112 in the form of loops may also be formed on the Liner Curtain Holder 100 by folding and binding the panel over itself. Alternatively, rings 114 may be looped through the holes 112 and around a rod to facilitate connection. The loop cache 120 is located along the length of the bottom edge of the panel holder 110 and top edge of the panel 130 . [0020] The panel holder 110 may be constructed of natural or synthetic materials typically used for shower or window curtains, such as cotton, linen, polyester, plastic, or vinyl. Referring to FIG. 3 , in an alternative embodiment, the bottom edge of the panel holder 110 may split to form two layers with two loop caches 120 for the attachment of two panels 130 . Having an attachment place for more than one panel 130 allows for a waterproof and decorative liner to be used for a shower or several layers of curtain panels to be used as window treatments. [0021] The panel 130 , illustrated in FIGS. 1-3 , is typical of panels used for shower curtains, liners, or window curtains with a generally square or rectangular shape and having a horizontal top edge, a horizontal bottom edge and two vertical side edges. The panel 130 , may function to retain water with in a shower or bathtub as shown in FIG. 1 , prevent light from entering a window as shown in FIG. 2 , or as a decorative embellishment to windows. The panel 130 can be composed of a manmade or synthetic materials typically used for the aforementioned panel 130 functions, and may be flexible or rigid. [0022] Referring to FIGS. 1 and 6 A-B, the panel 130 may comprise a rod 132 along its top edge. The rod 132 functions to retain the shape of the panel 130 and to facilitate connection of the panel 130 to the panel holder 110 by incorporating the loop cache 120 . The rod 130 may be made from any material that is semi-rigid or rigid, and can be formed from the same material as the panel 130 but as a thicker section. [0023] The loop cache 120 , best illustrated in FIGS. 1-3 , 4 A- 4 B and 6 , joins the panel 130 with the panel holder 110 by incorporating a series of complimentary interlocking loops, clips, clasps, zippers, magnets. The complimentary interlocking loop cache 120 surfaces are capable of being removably attached to each other. The bottom edge of the panel holder 110 and top edge of the panel 130 each comprise one of the complimentary loop cache 120 surfaces. Alternatively, the loop cache 120 may incorporate a hook and loop fastener or adhesive membrane. In an alternate embodiment, the loop cache 120 may comprise an elongated trough with protrusions 133 along its length so that when the rod 132 on the liner 130 is pressed into the loop cache 120 , by hand or using a tab lock 124 , the two will become attached to each other. [0024] The tab lock 124 , best illustrated in FIGS. 4A , 4 B, 5 and 7 , functions as a closure mechanism to join the loop caches 120 of the panel holder 110 with the liner 130 . The tab lock 124 can slide across the width of the panels like the pull-tab of a zipper, compressing and joining the complimentary loop cache 120 surfaces together. A tab lock holder 116 , as best illustrated in FIGS. 5A-B , functions as a catchment incorporated into the panel holder 110 and tab lock 124 where the loop cache 120 closure mechanism remains after attachment of the panel 130 . The tab lock holder 116 prevents detachment of the loop cache 120 from the panel holder 110 by locking the loop cache closure in place. The catchment may utilize fastening methods such as a snap, tab, hook, loop, string, or hook and loop fastener. [0025] To use the panel hanging system illustrated in FIGS. 1-8 , the panel holder 110 is first affixed to a ceiling or wall using the holes 112 and optionally rings 114 in conjunction with a rod or pole. Once the panel holder 110 is attached, a panel can be hung from it by positively engaging the complimentary surface of the loop cache 120 together. Optionally, the tab lock 124 can be used to facilitate joining the loop cache 120 surfaces together by engaging the ends of the loop cache 120 together and then sliding the tab lock 124 across the panel holder 110 . Next, the tab lock holder 116 of the tab lock 124 can be attached to the panel holder 110 . To remove the panel, simply detach the tab lock holder 116 of the tab lock 124 from the panel holder 110 , then slide the tab lock 124 across the panel holder 110 and panel 130 so that the two are free from each other. The panel 130 may now be exchanged for a different one and reattached using the aforementioned procedure. [0026] All features disclosed in this specification, including any accompanying claim, 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. [0027] 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, paragraph 6. In particular, the use of “step of” in the claims herein is not intended to invoke the provisions of 35 U.S.C. §112, paragraph 6. [0028] Although preferred embodiments of the present invention have been shown and described, various modifications and substitutions may be made thereto without departing from the spirit and scope of the invention. Accordingly, it is to be understood that the present invention has been described by way of illustration and not limitation.

1a

CROSS REFERENCE TO RELATED APPLICATION This application is a divisional application of U.S. patent application Ser. No. 10/654,797 filed Sep. 4, 2003 entitled “HEAT AND MOISTURE FILTER EXCHANGER AND METHOD”, now U.S. Pat. No. 7,347,203 issued Mar. 25, 2008. That application claims the benefit of prior filed copending U.S. provisional application Ser. No. 60/411,213 filed Sep. 16, 2002 entitled “HEAT AND MOISTURE FILTER EXCHANGER AND METHOD” by Gregory S. Marler and David T. Sladek. BACKGROUND OF THE INVENTION The present invention relates generally to systems for respiratory therapy, particularly to ventilator systems that includes heat and moisture exchanger (HME) media or heat and moisture exchanger (HME) media in the respiratory path and also provides the additional capability of administering aerosol medication to a patient effectively without interrupting the respiratory path. The closest prior art is believed to be illustrated in FIG. 1 , in which a conventional heat and moisture exchanger (HME) 1 has a port 2 connected to a port 3 of a bypass device 4 . Bypass device 4 is marketed by DHD Healthcare of Watsonville, N.Y. under the trademark CIRCUVENT. Heat and moisture exchanger 1 has a port 5 connected to port 6 of a Y connector 10 having a connector which is coupled to an endotracheal tube (not shown) in the patient. Bypass device 4 includes another port 7 connected to one end of a flexible bypass tube 8 having its other end connected to another port 9 of Y connector 10 . Bypass device 4 has a port 11 connected by suitable tube to a ventilator (not shown). A rotatable control ring 13 can be adjusted so that gas received through port 11 from the ventilator is selectively routed through either heat and moisture exchanger 1 or bypass tube 8 . If aerosol medication is introduced into the respiratory path upstream from port 11 , then control ring 13 is turned to direct the gas carrying the aerosol medication around heat and moisture exchanger 1 through bypass tube 8 . This prevents the aerosol droplets/particles from impacting on the media of heat and moisture exchanger 1 (and any filter material that may be provided with it). The bypass tube 8 of the assembly shown in FIG. 1 has a large volume of “dead space” which results in a relatively large amount of previously exhaled air being re-breathed by the patient. This reduces the amount of oxygen received by the patient's lungs and is always undesirable, and in some instances can be dangerous, especially for a critically ill infant being supported on a ventilator. The assembly shown FIG. 1 is bulky, relatively heavy, and tends to be leaky. The cost of a typical HME or HMEF element 1 or an HCH element can be in the range from approximately $1.50 to $5.00, and the bypass device 4 can cost from approximately $3.50 to $7.00. Thus, there is an unmet need for a device and method for selectively conducting a stream of air produced by a ventilator through a moisturizing medium in the device or internally bypassing the moisturizing medium to prevent aerosolized medication that has been introduced into the stream from contacting the moisturizing medium. There also is an unmet need for such a device and method that reduces the cost of selectively conducting a stream of air produced by a ventilator through a moisturizing medium in the device or internally bypassing the moisturizing medium to prevent aerosolized medication that has been introduced into the stream from contacting the moisturizing medium. There also is an unmet need for such a device and method that reduces the cost of selectively conducting a stream of air produced by a ventilator through a moisturizing medium in the device or internally bypassing the moisturizing medium to prevent aerosolized medication that has been introduced into the stream from contacting the moisturizing medium, wherein the device and method also reduce the risk of infection to the patient. There also is an unmet need for such a device and method that reduces the cost of selectively conducting a stream of air produced by a ventilator through a moisturizing medium in the device or internally bypassing the moisturizing medium to prevent aerosolized medication that has been introduced into the stream from contacting the moisturizing medium, wherein the device and method also reduce the risk to the patient associated with a large volume of a “dead space” in the respiratory path. SUMMARY OF THE INVENTION It is an object of the present invention to provide a device and method that reduces the cost of selectively conducting a stream of air produced by a ventilator through a moisturizing medium in the device or internally bypassing the moisturizing medium to prevent aerosolized medication that has been introduced into the stream from contacting the moisturizing medium. It is another object of the present invention to provide an improved unitary device and a method for selectively conducting a stream of air produced by a ventilator through a moisturizing medium in the device or internally bypassing the moisturizing medium to prevent aerosolized medication that has been introduced into the stream from contacting the moisturizing medium. It is another object of the present invention to provide a device and method that reduces the cost of selectively conducting a stream of air produced by a ventilator through a moisturizing medium in the device or internally bypassing the moisturizing medium to prevent aerosolized medication that has been introduced into the stream from contacting the moisturizing medium and that also reduces the risk of infection to the patient. It is another object of the invention to provide a device and method that reduces the cost of selectively conducting a stream of air produced by a ventilator through a moisturizing medium in the device or internally bypassing the moisturizing medium to prevent aerosolized medication that has been introduced into the stream from contacting the moisturizing medium and that also reduces the risk to the patient associated with a large volume of “dead space” in the respiratory path. Briefly described, and in accordance with one embodiment, the present invention provides a heat and moisture exchanger for selectively conducting a stream of air produced by a ventilator through a moisturizing medium or internally bypassing the moisturizing medium if aerosolized medication is introduced into the stream, the device including a housing having a ventilator-side port coupled to a ventilator and a source of aerosolized medication, the housing also having a patient-side port coupled to a patient to provide ventilation including either air or air with aerosolized medication. A first path within the device conducts non-aerosolized air between the ventilator-side port and the patient-side port, and a second path conducts air carrying aerosolized medication between the ventilator-side port and the patient-side port. A two-way valve mechanism is included within the housing for selectively coupling the ventilator-side port into fluid communication with one or the other of the first and second paths. In one embodiment, the heat and moisture exchanger includes a housing having a ventilator-side port ( 21 ) configured to be coupled to an outlet of a ventilator and a source of aerosolized medication, the housing also having a patient-side port ( 25 ) configured to be coupled to a patient to provide ventilation to the patient. The structure within the housing forms a first path for conducting non-aerosolized air from the ventilator-side port through the moisturizing medium to the patient-side port and a second path for conducting air carrying aerosolized medication from the ventilator-side port to the patient-side port by bypassing the moisturizing medium. The two-way valve mechanism in the housing selectively couples the ventilator-side port into fluid communication with one or the other of the first and second paths. An external valve control ( 230 ) extends through the housing to control the two-way valve mechanism. A tube ( 37 ) is supported between the ventilator-side port ( 21 ) and the patient-side port ( 25 ), wherein the second path extends entirely through the tube. The two-way valve mechanism selectively blocks or opens a portion of the second path extending through the tube ( 37 ) in response to the external valve control ( 230 ). The moisturizing medium ( 15 ) is disposed between an outer surface of the tube ( 37 ) and an inner surface of the housing. The first path extends around the tube and through the moisturizing medium. A gap ( 55 ) between a first end of the tube ( 37 ) and the ventilator-side port ( 21 ) forms part of the first path. The two-way valve mechanism includes a butterfly valve coupled to an actuator mechanism. The valve includes a valve disk 74 integral with a cylindrical valve post 78 having a female coupling element 77 at its upper end which mates with a the mail coupling device 73 A. The actuator mechanism includes an actuation knob ( 73 ) external to ventilator-side housing 400 , an actuator stem 73 extending through ventilator-side housing 400 and having the male coupling element 73 A at its lower end. The moisturizing medium ( 15 ) is annular and is disposed around the tube ( 37 ), an inner surface of the moisturizing medium forming a seal with an outer surface of the tube, an outer surface of the moisturizing medium forming a seal with an inner surface of the housing. The housing is cylindrical, and wherein the inner surface and outer surface of the moisturizing medium are cylindrical. The ventilator-side section ( 220 ) includes a plurality of integral support members 54 which support the tube ( 37 ) in axial alignment between the ventilator-side port ( 21 ) and the patient-side port ( 25 ). BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevation view of a prior art assembly including an HME device and a bypass unit. FIG. 2 is a side elevation view of a HME/bypass unit according to the present invention. FIG. 2A is a block diagram showing a connection of the HME/bypass unit of FIG. 2 in a ventilator circuit. FIG. 3 is a longitudinal section view showing the interior of the HME/bypass unit of FIG. 2 . FIG. 4 is a perspective right upper view showing the interior of the ventilator-side section 22 of the HME/bypass unit of FIGS. 2 and 3 . FIG. 5 is a perspective left view showing the interior of the patient-side section 35 of the HME/bypass unit of FIGS. 2 and 3 . FIG. 6 is a perspective lower right view of the valve plate 23 of the HME/bypass unit of FIGS. 2 and 3 . FIG. 7 is an a front upper perspective view of another embodiment of a HME/bypass unit according to the present invention. FIG. 8 is a longitudinal section view showing the interior of the HME/bypass unit of FIG. 7 . FIG. 9 is a perspective view showing the interior of the ventilator-side section of the HME/bypass unit of FIG. 7 . FIG. 10 is an elevation view of a butterfly valve assembly included in the ventilator-side section of the HME/bypass unit in FIG. 9 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIGS. 2 , 2 A and 3 - 6 , an HME/bypass device 20 includes a ventilator-side section 22 having a ventilator-side port 21 , and a patient-side section 35 having a patient-side port 25 . A knurled, rotatable collar 23 A of a valve plate 23 is used to control a 2-way valve located inside of a complete housing including both ventilator-side section 22 and patient-side section 35 . The outer surface of ventilator-side port 21 is partially knurled, as shown. A CO2 monitoring port 42 is provided as an integral part of a ventilator-side section 22 , and a drainage port 43 is provided as an integral part of patient-side section 35 . FIG. 2A shows a ventilating system 100 in which HME/bypass device 20 can be connected, wherein a ventilator 101 is coupled by suitable respiratory tubing to one port of an MDI (metered dose inhaler) injection device 103 having an opposite port connected by suitable respiratory tubing to ventilator-side port 21 of HME/bypass device 20 . HME/bypass device 20 includes a patient-side port 25 which is connected to an endotracheal tube 107 that has been intubated into the trachea of a patient. The air pumped by ventilator 101 into ventilator-side port 21 does not carry any aerosolized medication unless an MDI canister 105 is inserted into MDI injection device 103 and depressed so as to open the valve of MDI canister 105 . Knurled collar 23 A is initially set to a position that causes air from ventilator 101 to pass through an optional annular bacterial and viral filter 48 disposed in ventilator side chamber 40 A and through an annular HME element 15 in the patient side chamber 50 A (as shown in FIG. 3 ) and then through patient-side port 25 and endotracheal tube 107 into the lungs of the patient. If it is desirable to administer aerosolized medication to the patient, then knurled collar 23 A is rotated 90 degrees to a second position which causes air pumped by ventilator 101 to pass directly from ventilator-side port 21 through patient-side port 25 without passing through HME element 15 or the optional bacterial and viral filter element 48 . Then, an MDI canister 105 containing the desired medication is inserted into an injection port of MDI injection device 103 and depressed so as to open a valve of MDI canister 105 and thereby cause a plume of medication droplets/particles to be sprayed into the air stream produced by ventilator 101 . The plume of medication droplets/particles is carried directly through an un-obstructed path through HME/bypass device 20 and endotracheal tube 107 into the lungs of the patient. This prevents medication droplets/particles from being deposited on HME element 15 or the optional bacterial and viral filter element 48 . Alternatively, a device other than an MDI injection device 103 , such as a liquid nebulizer, might be used to introduce aerosolized medication into the stream of air produced by ventilator 101 . Referring to FIGS. 3-6 , ventilator-side port 21 of HME/bypass device 20 includes a cylindrical passage 21 A that extends into an interior first chamber 40 A bounded by a first chamber wall 40 that is integral with the cylindrical tube that forms/bounds passage 21 A. A portion of passage 21 A extends into first chamber 40 A and forms a cylindrical left cage 30 , the right end of which includes a narrow cylindrical section 31 . Half of the right end of passage 21 A is blocked by two sections of a circular disk 32 , as shown in FIG. 4 . As shown in both FIGS. 3 and 4 , the main cylindrical wall of cage 30 has a number of elongated, rectangular, uniformly spaced openings 30 A. The right peripheral edge of ventilator-side section 22 is bounded by a planar, annular surface 34 ( FIG. 4 ) which abuts and slides against a corresponding annular planar surface of annular ring 23 B of valve plate 23 , as shown in FIG. 6 . An O ring 45 A is disposed in a circumferential O ring grove 45 around the outside surface of chamber wall 40 and performs a seal with the inside surface diameter of knurled collar 23 A. A receiving boss 81 is positioned on the inside diameter of chamber wall 40 to receive a keying post 52 ( FIG. 5 ) to ensure proper alignment of patient-side section 35 with ventilator-side section 22 , annular ring 23 B of valve plate 23 being “sandwiched” between annular planar face 34 of ventilator-side section 22 and annular planar surface 50 B of patient-side section 35 . Keying post 52 also acts as a stop to limit the 90 degree rotation of valve plate 23 in either direction by engaging the portions of spokes 23 C and 23 G between outer ring 23 B ( FIG. 6 ) and middle ring 23 D. The details of valve plate 23 are shown in FIG. 6 . Knurled collar 23 A surrounds and is rigidly attached to a planar structure including two flat, co-planar, diametrically aligned spokes 23 C and two flat, co-planar, diametrically aligned spokes 23 F which are perpendicular to spokes 23 C. The planar structure also includes three flat, co-planar, concentric, annular rings, including above mentioned outer annular ring 23 B, and also includes middle ring 23 D and inner ring 23 E. Outer ring 23 B is rigidly attached to the inner diameter surface of knurled collar 23 A, and is connected to the outer end of each of spokes 23 C. Middle ring 23 D is attached to a mid portion of each of spokes 23 C. The inner end of each of spokes 23 C is rigidly attached to opposed portions of the outer cylindrical surface of an outer cage 70 . An outer end of each of spokes 23 F is attached to and integral with middle ring 23 D. The inner end of each of spokes 23 F is rigidly attached to opposed portions of the outer cylindrical surface of outer cage 70 . A main cylindrical surface of outer cage 70 ( FIG. 6 ) has therein a plurality of uniformly spaced, elongated openings 70 A that can be selectively aligned with or misaligned with openings 60 A in inner cage 60 ( FIG. 5 ) in order to either (1) allow air from ventilator 101 ( FIG. 2A ) to flow through HME element 15 and openings 60 A or (2) block openings 60 A. The selective alignment or misalignment is achieved by rotating knurled collar 23 A through 90 degrees (relative to the complete chamber wall 40 , 50 with valve plate 23 “sandwiched” between left annular surface 34 and right annular surface 50 B). A semi-circular disk 24 covers half of the inner end of outer cage 70 . Two sectors of circular disk 24 cover part of the inner end of outer cage 70 . Referring to FIGS. 5 and 6 , the inner surface of outer cage 70 of valve plate 23 can slide over the outer surface of inner cage 60 of a ventilator-side section 22 when it, valve plate 23 , and patient-side section 35 are assembled into the unitary structure shown in FIGS. 2 and 3 . The annular, planar face 50 B of patient-side section 35 abuts and slides against the front face of outer ring 23 B ( FIG. 4 ), and the keying post 52 attached to the inner surface of right chamber wall 50 of patient-side section 35 extends into the corresponding receiving boss 81 of left chamber wall 40 . A second O ring groove 46 ( FIGS. 3 and 5 ) is circumferentially formed in the outer surface of chamber wall 50 , and a second O ring 46 A is supported in second O ring groove 46 . The first O ring 45 A forms a seal between valve plate 23 and ventilator-side section 22 , and the second O ring 46 A forms a seal between valve plate 23 and patient-side section 35 . Ventilator-side section 22 and patient-side section 35 both will be permanently snapped on to valve plate 23 . Preferably, all of the components of HME/bypass device 20 with the exception of the HME element 15 and the optional bacterial and viral filter are composed of suitable plastic, such as clear ABS plastic, acrylic, polycarbonate, or polypropylene. When valve plate 23 is rotated to a first position such that its two openings 24 A are precisely aligned with the two openings 60 A of ventilator-side section 22 , then semicircular opening 24 A adjacent to disk sectors 24 are also precisely aligned with the openings 32 A adjacent to disk sectors 32 , thereby providing a clear passage from ventilator-side port 21 to patient-side port 25 . At the same time, the solid “vanes” 70 B of outer cage 70 ( FIG. 6 ) are precisely aligned with openings 60 A of inner cage 60 , and thereby prevent air carrying aerosolized medication from passing through HME element 15 , optional bacterial and viral filter 48 , and openings 60 A, so essentially all of the aerosolized medication flows unobstructed through the endotracheal tube 107 into the patient's bronchial passages and lungs. When valve plate 23 is rotated 90 degrees from the first position to a second position such that its disk sectors 24 are precisely aligned with the openings 32 A of ventilator-side section 22 , then disk sectors 32 adjacent to openings 32 A are also precisely aligned with openings 24 A adjacent to disk sectors 24 , thereby completely blocking passage of the air from ventilator-side port 21 directly to patient-side port 25 and diverting all of such air from passage 21 A through openings 30 A of left cage 30 into the first chamber 40 A through optional bacterial and viral filter 48 , and through the various gaps between rings 23 B, 23 D and 23 E so the air flows into second chamber 50 A, through HME element 15 in second chamber 50 A, and then through the openings 70 A of outer cage 70 and the aligned openings 60 A of inner cage 60 and into passage 25 A. Another embodiment of the HME/bypass device of the present invention is shown in FIGS. 7-10 . This embodiment has a substantially simpler internal valve structure and an easier-to-use external control for switching between HME operation and bypass operation in which aerosol medication is introduced into the air stream generated by ventilator 101 . Where appropriate, the same or similar reference numerals used in FIGS. 2-6 are also used in FIGS. 7-10 , sometimes with an added “0”. Referring to FIGS. 7-10 , HME/bypass device 200 includes a ventilator-side section 220 and a patient-side section 350 that can be press-fit or snap-fit onto ventilator-side section 220 . Ventilator-side section 220 has a ventilator-side port 21 having an inlet passage 21 A, gas sampling port (not shown, but similar to port 42 of FIG. 2 ), and two generally cylindrical ventilator hose connecting surfaces, one being the inner surface of ventilator-side port 21 and the other being the outer surface of a smaller-diameter concentric cylindrical tube 21 B. A standard ventilator hose for coupling to intubated adults can be connected to the inner surface of port 21 , and a smaller ventilator hose for coupling to intubated children can be connected to the outer surface of concentric cylindrical tube 21 B. Similarly, a smaller ventilator hose can be coupled to the inner concentric cylindrical tube 25 B on patient-side port 25 for coupling to a ventilator circuit adapted for children. A butterfly valve assembly is mounted axially within the housing formed by ventilator-side housing 400 and patient-side housing 500 . The valve assembly, shown in FIGS. 8-10 , is supported by six vanes 54 which are integral to the ventilator-side housing 220 and are symmetrically positioned around a gas flow path that is concentric with ventilator-side housing 220 . A cylindrical valve housing 37 is axially supported by the inner edges of the six vanes 54 . One or more of the opposed vanes 54 extends between a pair of axial ribs 58 , which are integral with the valve housing 37 and which are spaced far enough apart to accommodate the vanes 54 . The vanes 54 support valve housing 37 so that the end thereof closest to the wall of ventilator-side housing 220 is spaced from it by a gap 55 through which air from ventilator 101 can flow when the valve is closed, thereby causing the air from ventilator 101 to be diverted around, rather than through the valve housing 37 . A semicircular slot 38 in the upper surface of valve housing 37 is wide enough to allow the planar, semicircular vanes 74 of the butterfly valve and a valve post 78 to which vanes 74 are attached to pass through during assembly. The diameter of the circle formed by the outer edges of the two vanes 74 is slightly less than inside diameter of cylindrical valve housing 37 , in order to allow the butterfly valve to be smoothly opened and closed by rotating an actuation knob 230 attached to the upper end of a valve actuation stem 73 having a lower male coupling element 73 A which engages a female coupling element 77 attached to the top of valve post 78 . As shown in FIG. 8 , HME filter 15 has an annular shape and fits snugly over the outer surface of valve cylinder 37 . The outer radial surface of HME filter 15 fits snugly against the inner cylindrical surface of patient-side housing 500 . Therefore, when the butterfly valve is closed so that vanes 74 block the inner cylindrical passage through valve cylinder 37 , air from ventilator 101 passes through an annular gap 55 and through HME filter 15 before then passing through patient-side port passage 25 A and through a suitable ventilator hose to endotracheal tube 107 ( FIG. 2 ). However, if actuation knob 230 is rotated 90 degrees from its closed position so that vanes 74 are parallel to the longitudinal axis of valve cylinder 37 , then air from ventilator 101 containing aerosol medication injected from MDI canister 105 into the airstream by means of MDI injection port 103 , passes freely through the unrestricted valve cylinder 37 and from there into the intubated patient, without loss of any medication particles that would otherwise be removed by HME filter 15 . The structure of the valve assembly including vanes 74 and valve post 78 is shown in FIG. 10 . A flexible snap-on anchor 78 A is provided at the bottom of valve post 78 , and has an associated slot 78 D provided in the lower end of valve post 78 to allow flexing that allows the bottom end of valve post 73 to be snapped into and retained in a hole 41 in the bottom of valve cylinder 37 . The bottom of female coupling element 77 limits the depth to which vanes 74 can be passed through slot 38 and an upper hole 44 in valve housing 37 . A valve actuator stem 73 extends through O-ring 57 ( FIG. 8 ) and ventilator-side housing 400 with the male coupling element 73 A at its base being press fit into an opening 77 A in female coupling element 77 . O-ring 57 is disposed around actuator stem 73 to provide a rotary seal between stem 73 and the ventilator-side housing 400 , and is housed within knob 230 between the inside surface of a boss on the top of ventilator-side housing 400 and actuator stem 73 . Ramp style detents (not shown) are provided on the outer surface of ventilator-side housing 400 to conveniently index control knob 230 to either its “valve closed” or HME position or its “valve open” or bypass position. Preferably, all of the components of HME/bypass device 200 , with the exception of the HME element 15 and the optional bacterial and viral filter, are composed of suitable plastic, such as clear ABS plastic, acrylic, polycarbonate, or polypropylene. HME/bypass device 200 is easily assembled by first inserting the valve mechanism snap fit element 78 A through hole 44 and semicircular slot 38 in valve housing 37 until the bottom of female coupling element 77 comes into contact with the outside diameter of valve housing 37 . Valve housing 37 is then inserted between the inside edges of the six radial vanes 54 and pressed into position as shown in FIGS. 8 and 9 . Actuator stem 73 is subsequently fed through the inside diameter of O-ring 57 and hole 47 in ventilator-side housing 400 with male coupling element 73 A being press fit into female coupling element 77 . HME element 15 is then placed between the outside surface of valve housing 37 and the inside surface of ventilator-side housing 400 , as shown in FIG. 8 . Finally, ventilator-side housing 400 is press fit into patient-side housing 500 , completing the assembly. As is the case for the HME/bypass device 20 of FIGS. 1-6 , an optional bacterial and viral filter 48 can be provided within HME/bypass device 200 , and a gas sampling port 42 and/or a drainage port 43 as shown in FIG. 3 also can be provided for HME/bypass device 200 . The described HME/bypass devices have far smaller “dead space” than the bypass tube 8 of the prior art CIRCUVENT device 4 shown in FIG. 1 . The described HME/bypass devices, especially HME/bypass device 200 , are much smaller, lighter, less expensive, and easier to use than the combination of the prior art CIRCUVENT device with an HME device or HME device connected thereto. The cost of manufacture of HME/bypass device 200 is expected to be only slightly higher than the cost of prior HME devices alone, and much lower than the total cost of the prior art CIRCUVENT device in combination with a conventional HME device connected therein as shown in FIG. 1 . While the invention has been described with reference to several particular embodiments thereof, those skilled in the art will be able to make the various modifications to the described embodiments of the invention without departing from the true spirit and scope of the invention. It is intended that all elements or steps which are insubstantially different or perform substantially the same function in substantially the same way to achieve the same result as what is claimed are within the scope of the invention.

1a

This is a divisional application of U.S. Ser. No. 09/909,355, entitled Baseball Swing Training Apparatus and Method of Using Same, filed on Jul. 18, 2001 now abandoned, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates generally to athletic training devices and more specifically to baseball swing training devices for developing a short compact swing. 2. Description of the Prior Art The application of the continued study of body mechanics has resulted in numerous devices purporting to maximize the desired effect of a particular motion. Such devices are particularly evident in the sporting industry. However, as the motions required in each sport provide a unique set of mechanics, the instruments are typically specifically tailored to improving a precise motion for a particular sport and often a specific motion. For example, in baseball or softball, several attempts have been proposed to allegedly improve a batter's swinging motion. One such device focuses on training the batter to shift his weight during his swing and can be found in U.S. Pat. No. 5,704,856 to Morse. This reference discloses a pair of straps spaced apart by an elongated two-piece connective member having a length adjustable portion with a release buckle and an elastic portion. Such straps are respectively connected to the lead forearm and lead leg above the knee. By moving the lead arm rearwardly and upwardly at the beginning of the swing, the lead leg, which is coupled to the lead arm, is pulled upwardly and rearwardly such that the batter must shift his or her weight to the back leg to maintain a balanced stance. As the swing progresses, the lead arm is lowered and the batter is able to shift his weight forward to the front leg. The length of such device must accommodate the placement of the two straps on the lead arm and lead leg which results in a significant slackened portion as the batter advances through the swing. While such section is slackened, the device does not assist the batter's swing motion. The focus of such device is on weight transfer and does not improve upper body swing mechanics. Another such device can be found in U.S. Pat. No. 5,154,416 to Smull et al. This bottom swing developer includes a harness having a pair of loops through which the arms are placed. The loops are worn against the body and connected across the torso in front and back of the batter. A restraining member having a predetermined length connects the wrist of the top hand to the harness to purportedly restrict the top hand from dominating the batting swing. Such device appears to constrict the batter's swing by inhibiting a complete follow through due to restraining the top hand from turning over and preventing the top arm from fully extending. In addition to weight transfer and maintaining equal balance in the hands, it is often desirable in baseball or in softball, to develop a short compact swing such that the arms are kept in tight to the body for a significant portion of the swing path enabling the batter to guide the bat with increased accuracy in relation to the incoming ball and get the bat around in a hurry by avoiding wasted motion. Such a swing avoids casting related injuries such as bad backs and being hit by pitches due to an overextension of the arms. By developing a short compact swing, the distance the bat must travel is reduced and thus the batter may also benefit from increased swing speed. One such device which attempts to address swing characteristics is illustrated in U.S. Pat. No. 5,114,142 to Gillespie et al. The training device disclosed in Gillespie includes a belt encircling the chest of the batter and second belt for encircling the batter's upper arm. The two belts are connected by a short length of material to secure the encircled upper arm close to the body in a locked in position throughout the swing while allowing the respective forearm to produce some movement to effect a swing of the bat. The device alleges to promote proper hip and top hand action to generate more power. However, it is apparent that the batter is severely restricted in his swing and can not direct his hands across his chest as is desirable in a short compact swing. Another device which takes an alternative approach to improving swing characteristics is shown in U.S. Pat. No. 5,260,209 to Mollica. Such device is used in lieu of a conventional bat and includes a handle connected to a cylindrical stem extending from the handle and terminating in a stop. A weighted member is slidably mounted to the stem and allegedly moves into a correct position upon establishing a proper swing. Incorrect movement of the weighted member is purported to indicate an error in the swing. Since such training device is used in lieu of a baseball bat, the user is prevented from practicing while hitting an actual ball. Another common theme appearing in each of these devices is the lack of any indication of the proper starting position. As the initial set up of the swing path is critical in developing a consistent swing, a lack of indication of the proper starting position is a serious shortcoming. What is needed and heretofore unavailable is an easy to use baseball swing training device which provides an indication of the proper starting position and builds muscle memory to develop a short compact swing for increased hitting accuracy. Such device should inhibit introduction of poor swing characteristics and also be relatively inexpensive, easy to manufacture, and adjustable to any number of body profiles. SUMMARY OF THE INVENTION In accordance with the present invention, a batting swing training apparatus is provided having an adjustable elongated tensioning member interposed between a first adjustable attachment member which may be connected to the lead arm of the batter at a point above the elbow and a second attachment member which may be connected to the trailing arm of the batter at the wrist during use. Such an apparatus may be donned to impart muscle memory and train a batter in the proper swing mechanics by inducing a tension at critical swing positions to produce a proper initial swing position and subsequent motion through critical points during the swing. Methods for using such apparatus to provide a visual indicator of a proper starting position, prevent unwanted casting motion, and accelerating through the contact point of the swing are also described herein. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a preferred embodiment of the present invention; FIG. 2 is a partial view, in enlarged scale, of the embodiment shown in FIG. 1; FIG. 3 is sectional view, in enlarged scale, taken along lines 3 — 3 shown in FIG. 2; FIG. 4 is a front view of a batter, in reduced scale, illustrating the attachment points of the preferred embodiment of the present invention illustrated in FIG. 1; FIG. 5 is a partial top view, in enlarged scale, of a batter in an initial batter's stance and wearing the preferred embodiment of the present invention; FIG. 6 is an elevated front view of a batter gripping a bat while wearing the preferred embodiment of the present invention; FIG. 7 is an elevated front view of the batter wearing the preferred embodiment of the present invention illustrating an improper alignment; FIG. 8 is a front view of a batter assuming an initial batter's stance and wearing the preferred embodiment of the present invention; FIG. 9 is a front view of the batter shown in FIG. 8 beginning a swing motion; FIG. 10 is a front view of the batter shown in FIG. 8 in a quarter swing position; FIG. 11 is a front view of the batter shown in FIG. 8 just prior to striking a baseball; FIG. 12 is a front view of the batter shown in FIG. 8 in a full contact position; FIG. 13 is a front view of the batter shown in FIG. 8 in a three-quarter swing position; and FIG. 14 is a front view of the batter shown in FIG. 8 completing the swing. Numerous advantages and aspects of the invention will be apparent to those skilled in the art upon consideration of the following detailed description and attached drawing figures referenced therein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to FIGS. 1 and 4, a baseball swing training device, generally designated 30 , includes an adjustable, elongated, elastic tensioning member 32 comprising adjacent sections having a first attachment member 34 attached to one of its sections and a second attachment member 36 attached to the opposing section. The training device is connectable to the leading arm 40 and trailing arm 42 of a batter 43 to develop a proper swinging motion by reinforcing a batter's muscle memory corresponding to a preferred batting swing. For purposes of this invention “baseball” will be understood to refer to any baseball-like game, such as softball, over-the-line, stickball and the like. “Leading arm” will be understood to mean that arm on the side from the ball is delivered. For example the leading arm of a right handed batter is the left arm. The tensioning member 32 is constructed of a single piece of an elastic material with a cloth covering and preferably is a section of a bungee cord which can purchased from Bungee International Mfg. Corp in Chatsworth, Calif. The tensioning member 32 is preferably about 12 to 20 inches long in an unstretched condition and may stretch up to a length 36 inches long. These unstretched and stretched lengths have been found to accommodate a wide range of batter physiques, however, it will be appreciated that other combinations of such lengths may be selected to suitably accommodate different sized batters. It will further be appreciated that alternative stretch resistance characteristics of the tensioning member may be selected to provide a desired tension throughout the swing. The tensioning member is divided into two variable length sections including a first section forming an adjustable loop 38 and a second section providing a stretchable length of cord 40 terminating in an anchor loop 42 . Such anchor loop is formed by doubling back a relatively short length of the tensioning member in the stretchable section 39 and securing the loop with a clamping ring 41 . Separating the sections at an intermediate point along the length of the tensioning member is a slip ring assembly 44 including a pair of metallic rings which allows a portion of the cord in either section to be passed through to adjust the size of the adjustable loop 38 making its respective diameter smaller or larger as desired and respectively lengthening or shortening the length of the cord 40 . The slip ring assembly 44 pinches the tensioning member and frictionally retains the two adjacent sections of the tensioning member 32 so that no slippage will occur and maintain the respective sections in a desired configuration. By separating the rings in the slip ring assembly, a length of the tensioning member 32 may pass through the rings to adjust the overall length of the tensioning member. The tensioning member and slip ring combination may also be purchased at Bungee International Mfg. Corp in Chatsworth, Calif. It will be appreciated that the adjustability of the tensioning member 32 provides a training device 30 that is suitable for both children and adults. A portion of the adjustable loop 38 is connected to the first attachment member 34 via a double slotted clip 46 . More specifically, a section of the adjustable loop passes through one slot of the double slotted clip and a portion of the attachment member 34 passes through the other slot. The first attachment member itself is formed of a multi-layered band. The band includes four layers that are typically stitched together, adhered, or pinned or a combination of any of these three binding devices. For illustrative purposes, pins 47 are shown in FIGS. 2 and 3. These four layers cooperate to form an open ended loop allowing the batter to place his leading arm within the loop. The innermost first layer is a neoprene lining 48 to be placed against the batter's skin or uniform providing a cushioning layer. The second layer 50 is a nylon or woven cloth providing strength and terminates at one in a link 52 such as those available from XMSurf More Products located in San Clemente, Calif. These links have angled sides to better resist complete removal of a strip of material placed therein. The third layer 54 provides a bonding surface or anchor for the fourth layer 56 which includes a first fastener 58 formed with a pile material. As illustrated in FIG. 2, the third layer extends beyond the neoprene and woven cloth layers on one end to provide an extension 60 from which a second fastener 62 complementary to the first fastener 58 is secured preferably by a suitable means such as stitching. The first fastener includes a series of hooks on its outer surface as is typically provided in Velcro® fasteners. The first fastener 58 is dimensioned to pass through the link 52 and double back onto the second fastener in an overlapping arrangement to close the loop around the batter's leading arm 40 just above the elbow and resting against the elbow pit 71 (FIG. 4 ). The length of the first fastener 58 is sufficient to provide additional adjustability depending on the needs of the individual batter. A relatively tight but comfortable fit is preferred which ensures maximum assistance from the swing training device and thus should be adjusted until a snug fit is accomplished. Connected to the opposing end of the tensioning member 32 is the second attachment member 36 which is similar in construction but is dimensioned to be placed around the wrist 74 of the trailing arm 42 of the batter 43 in training. Typically, the dimensions are not as great and this attachment member is smaller in its maximum diameter than the maximum diameter of the first attachment member 34 because it is only required to fit on the batter's wrist 74 . More specifically, the anchor loop 42 of the stretchable section 39 is attached to a double slotted clip as previously described for the first attachment member. All other components of the second attachment member 36 are the same as for the first attachment member except for the dimensions and in referring to the figures, like components are like numbered. Referring now to FIGS. 4-14, the operation of the training device 30 will now be described in detail. As illustrated in FIG. 4, a batter 43 preparing to practice a right handed hitting motion dons the training device 30 by placing the first attachment member 34 just above the elbow 70 of the leading arm 40 of the batter. More specifically, the attachment of the first attachment member 34 is as follows. Assuming both attachment members are initially unfastened, meaning the second fastener 62 is not connected to the respective first fastener 58 , the batter 43 wraps the first attachment member 34 around the lead arm 40 just above the elbow 70 with the neoprene layer 48 facing inwardly and abutting the skin or uniform. The free end of the first fastener 58 is threaded through the clip 52 such that the hooks are facing outwardly. The free end is moved outwardly to fold back onto and mesh with the pile material of the complementary second fastener 58 forming a closed loop with a cushioning inner layer 48 around the batter's upper arm abutting the elbow pit 71 (FIG. 4 ). As desired, the snugness of the fit may be adjusted by loosening the first fastener 58 from the second fastener 62 and repositioning the amount of overlap of the first fastener with respect to the second fastener and then reattaching the complementary fasteners. When a desired comfort level has been attained, the first attachment member should be abutting the elbow pit 71 of the lead arm 40 . In a similar manner, the open looped second attachment member 36 is wrapped around the wrist 74 of the trailing arm 42 with the neoprene lining 48 on the inside contacting the skin or shirt of the batter. The batter 43 grasps the free end of the first fastener 58 and threads it through the clip 52 of the attachment member 36 (FIG. 1 ). By folding the first fastener 58 back onto and overlapping the second fastener 62 and placing it thereagainst to fasten the second attachment member 36 to the trailing arm 42 such that the loop is closed and abutting the trailing wrist 74 . If an adjustment is desired for a tighter fit, the first fastener 58 may be temporarily released from the second complementary fastener 62 by its free end and pulled through the clip 52 to reduce the diameter of the second attachment member loop. After both attachment members 34 and 36 have been adjusted to provide a comfortable fit, the right handed swinging batter 43 will have the training device 30 positioned as illustrated in FIG. 4 . While the training device 30 is sized to fit a wide cross section of batter proportions with respect to the attachment members 34 and 36 , the tensioning member 32 is also adjustable as to its initial unstretched length for additional adjustability. By sliding the rings of the slip ring assembly 44 away from one another, a section of the tensioning member 32 may be slid through both rings and either reduce the length of the stretchable cord 39 or increase the length as desired. The adjustable loop 38 will increase or decrease accordingly. It will be appreciated that this tensioning member 32 adjustment procedure could be performed with the training device 30 worn or unworn. While the incorporation of a bat 76 into the swing training procedure is not necessary to develop the desired muscle memory it assists in a more realistic feel for actual game situations and thus the remaining portion of the swing process will assume the batter 43 is grasping a baseball bat 76 in a conventional fashion as is shown in FIG. 6 for illustrative purposes. With both hands on the bat and the second set of knuckles 78 substantially aligned, the tensioning member 32 will be positioned in a relationship with the forearm 80 of the batter's leading arm 40 (FIGS. 5 and 6 ). At this time, there is little if any tension in the tensioning member 32 . Referring now to FIGS. 5 and 8, the batter 43 assumes the initial starting position or “loaded” position. In this position, the bat 76 is in a substantially vertical position and both hands have been brought up to the batter's chest 82 and moved rearwardly away from the direction of a pitcher (not shown). Typically, the batter's feet will point forwardly and flare slightly outwardly away from the batter's vertical centerline. In the loaded position, the elbows are flared outwardly as well thereby stretching the tensioning member 32 and inducing tension along its length. The hands are tucked up tight against the body and are positioned proximate the rearmost armpit 84 . As seen from above as in FIG. 5, the tensioning member 32 is substantially parallel with the leading forearm 80 . Thus, the batter 43 , when in the loaded position, may simply look down to view the tensioning member 32 the relationship with the leading forearm 80 . This is an illustration of a substantially correct starting position. On the other hand, if the batter 43 , while in the loaded position, looks down and sees that the tensioning member 32 is not substantially parallel with the leading forearm 80 , as illustrated in FIG. 7, then an adjustment is required. A typical reason for such misalignment is that the second set of knuckles 78 on the batter's respective hands are not substantially aligned. A slight adjustment bringing the second set of knuckles into alignment results in the parallel relationship between the tensioning member 32 and the leading forearm 80 . Advantageously, the training device 30 provides an early indication that the subsequent swinging motion may not be optimized by providing a relationship between the tensioning member 32 and leading forearm 80 easily visible to the batter 43 . While the correct grip is a positive precursor to the remainder of the swing, additional points along the batter's swing are critical as well such as the initial motion in reaction to the pitcher's motion. While in the proper starting position (FIGS. 5, 6 and 8 ), the increased length of the tensioning member 32 between the leading arm 40 and the trailing wrist 74 presents a tensile force perceivable to the batter 43 drawing the batter's elbows inwardly. The first motion of the batter 43 , upon initiating the swing, is to move the leading arm 40 in a linear motion across the chest region 82 toward the pitcher. The connection between the leading arm 40 and trailing wrist 74 via the tensioning member 32 ensures the trailing arm 42 will follow the leading arm 40 in the same linear motion across the chest 82 of the batter 43 initially. Advantageously, this reduces the tendency to develop a “casting” motion or move the hands away from the body instead of across the chest 82 . As it is desirable to avoid full arm extension prior to reaching the back of home plate with the bat 76 , the training device 30 advantageously prevents the undesirable casting motion which introduces arm extension prior to the appropriate point in a desirable swing position. Once a correct starting position is indicated (FIGS. 5 and 6 ), the batter 43 may begin either a practice swing to begin build muscle memory imparting a short compact swing or actually hit baseballs hurled by a pitcher or batting machine. Referring now to FIGS. 9 through 14, the batter 43 will begin to drive the knob 86 of the bat 76 toward the inside of an imaginary or teal baseball flight path. At this point the bat 76 is moving in a substantially linear direction and the shoulders and upper torso begin to turn toward the pitcher. The parallel relationship between the tensioning member 32 and the leading forearm 80 is substantially maintained up through this point in the swing. Referring now to FIG. 10, the batter 43 has turned further toward facing the pitcher including continuing turning the torso 82 to face the pitcher and bringing the hips around as well. The knob 86 of the bat 76 is still being driven toward a spot slightly inward of the path of the ball (not shown). The trailing wrist 74 and leading elbow 70 move closer together as the hands begin to extend away from the body. The inward motion of the trailing wrist 74 and/or leading elbow 70 decreases the length of the tensioning member 32 reducing the tension imparted to the batter 43 by the training device 30 . At this point, no tension is needed and the batter 43 progresses through the swing motion in a normal manner preparing to make contact with the ball while continuing to rotate toward the contact point. The batter 43 has avoided any casting motion. Referring now to FIG. 11, illustrating a swing position slightly prior to contact with the ball. The knob 86 of the bat 76 has been driven to slightly inside the path of the ball and the batter 43 is preparing to snap the top or trailing wrist 74 through and “hammer” through the ball. In other words, the batter's leading hand is palm down and the trailing hand is palm up as the wrists begin to rotate in relation to the respective forearm and induce a rotational motion and acceleration into the bat 76 bringing the contact surface of the bat 76 into a fully extended position. The hands have essentially ceased moving away from the body as the leading arm 40 is substantially straightened out. The tip of the bat 76 begins to travel in an arc as opposed to the previous linear motion produced in the earlier stages of the swing. The acceleration of the bat tip increases the impact force placed on the ball. This swing provides the shortest distance for a quicker swing speed while producing significant acceleration at the point of contact. FIG. 12 illustrates the batter's swing position at the contact point with the ball. As the trailing arm 42 enters into a straightened positioned substantially locking the elbow, the tensioning member 32 is again stretched a second time inducing tension between the attachment members 34 and 36 . Due to the connection between the leading arm 40 and the trailing arm 42 and travel path of the arms, the tensioning member 32 pulls on the second attachment member 36 located on the trailing wrist 74 to pull the trailing hand through the contact point and snap the wrist 74 through causing the bat to travel in a rapid fashion through an arc imparting significantly improved swing acceleration to the bat 76 through the contact point to drive the ball its maximum distance. Referring now to FIG. 13, the batter 43 continues with the follow through as the trailing wrist 74 of the top hand is straightened out as the trailing arm 42 is also straightened out fully extending the reach of the bat 76 which forms an outwardly projecting extension of the leading arm 40 . At this point the tensioning member 32 is again taut and substantially parallel to the leading forearm 80 . A continued follow through to the end of the swing motion with the leading arm 40 and trailing arm 42 coming together and the intermediate member 32 is slackened and does not interfere with the normal follow through (FIG. 14 ). It will be appreciated that the tensioning member 32 does not interfere with the swing of the batter 43 but instead provides feedback at three key points along the batter's swing including the initial loaded position, initial swing motion across the chest 82 , and just prior to the top hand hammer through prior to and during contact with the ball. By providing such feedback, the proper motion is reinforced at critical points along the swing to build muscle memory of the correct swing over repeated training sessions. At other less critical points along the swing the tensioning member is slack and does not interfere with the batter's swing motion. Continued usage of the training device 30 builds muscle memory and proper swing motion such that the batter 43 will develop an improved swing that eventually becomes the batter's natural swing even without using the training device 30 . Advantageously, the short compact swing developed by training with the training device 30 reduces the time between the start of the swing and the contact point by enforcing muscle memory to avoid unnecessary or wasted motion providing a swing with the shorter distance to the contact point. The reduction of unnecessary or sloppy motion provided by the in tight motion increases the bat control resulting in increased accuracy of the bat placement as well. Additionally, by shortening the swing path the batter 43 is able to view the ball longer after being pitched enabling more selective positioning of the striking center of the bat to place or drive the ball with greater accuracy. While several forms of the present invention have been illustrated and described, it will also be apparent that various modifications may be made without departing from the spirit and scope of the invention.

1a

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation application of PCT/US2008/72711 filed on Aug. 8, 2008, and hereby claims the benefit under 35 U.S.C. 120 of international application PCT/US2008/72711 filed on Aug. 8, 2008, and titled “Food Handling Device” wherein that application claims priority under 35 U.S.C. 119(e) from U.S. Provisional Application Ser. No. 60/935,393 filed on Aug. 10, 2007 wherein the disclosure of which is hereby incorporated herein by reference in its entirety. BACKGROUND This invention relates to a new type of eating utensil that enables users to comfortably manipulate food without the user's fingers coming into direct contact with the food. People often decide against eating foods such as chicken wings and barbequed pork ribs in order to avoid getting sauce on their hands and potentially their clothing. Even when conditions are acceptable for eating messy foods, people tend to avoid touching anything while their hands have sauce on them thereby precluding them from consuming beverages until they have finished eating the entire serving and have cleaned their hands. An additional benefit afforded by this device is the reduced likelihood of spreading disease causing viruses and bacteria. Thus, with this type of device there are also sanitation concerns that are addressed because now the user does not have direct contact with the food being handled except for directly eating the food instead of touching the food. U.S. Pat. No. 5,709,423 to Romero discloses a food gripper utensil. This food gripper utensil does not contain more than two limbs. Other patents that may generally relate include U.S. Pat. No. 7,165,270 to DeYoung et al; U.S. Pat. No. 3,501,191 to L. Darr; U.S. Pat. No. 7,287,791 to Carolina; U.S. Pat. No. 4,728,130 to Oretti; and U.S. Pat. No. 6,276,734 to Krieger. U.S. Pat. No. 5,848,928 to Wong, U.S. Pat. No. 1,156,459 to Brown, U.S. Pat. No. 5,653,488 to Ordonez, and U.S. Pat. No. 5,649,728 to Warthen. It is believed that the above art does not disclose a food handling device having at least three limbs and that is gripped along the center-line of the limbs of the utensil and is held by compression of the user's fingers against the limbs of the utensil which tend to flex into the open position. SUMMARY One embodiment of the invention relates to a food handing device comprising at least three limbs. The limbs comprise a first limb for receiving a first finger; a second limb for receiving a second finger; and a third limb for receiving a third finger. In this case while the term finger is used any type of digit such as a finger or a thumb can be used. In addition, there is at least one body section coupled to each of said first limb, said second limb, and said third limb said at least one body section forming at least one hinge for allowing at least one of said first limb, said second limb and said third limb to be movable about an axis formed on said body section. In this case, an optional but not required feature is that each limb can have at least one tooth. Some of the benefits of this type device is that with three limbs, it offers greater stability for a user when that user is eating food. In addition, because there are three limbs, that user can then stand the device on its end such that the distal ends of the limbs opposite the body are used to support the device in an upstanding manner such as in the form of a tri-pod. This allows a user to easily insert his or her fingers into the open end of the device to grasp the gripping device and then pick it up. BRIEF DESCRIPTION OF THE DRAWINGS Other objects and features of the present invention will become apparent from the following detailed description considered in connection with the accompanying drawings. It is to be understood, however, that the drawings are designed as an illustration only and not as a definition of the limits of the invention. In the drawings, wherein similar reference characters denote similar elements throughout the several views: FIG. 1 is a perspective right-side view of a three-limbed version of the utensil constructed in accordance with the invention: FIG. 2 is a perspective rear view of the utensil of FIG. 1 in the fully open position: FIG. 3 is a perspective front right-side view of the utensil of FIGS. 1 and 2 compressed to grasp a chicken leg: FIG. 4 is a perspective right side view of the utensil of FIGS. 1 , 2 , and 3 in hand and slightly compressed: FIG. 5 is a front view of a four-limbed version of the utensil constructed in accordance with the invention in a slightly uncompressed position: FIG. 6 is a front view of a two-limbed version of the utensil constructed in accordance with the invention in a slightly open position: FIG. 7 is a side view of a two-limbed version of the utensil in a slightly open position; and FIG. 8 is a perspective view of another embodiment; FIG. 9 is a view showing the axes of rotation and longitudinal axes of the limbs; FIG. 10 is a view of the device shown in FIG. 1 in a closed position; and FIG. 11 is a modified view of FIG. 4 . DETAILED DESCRIPTION FIG. 1 is a perspective right-side top view of a three-limbed version of the device 1 . The device includes a body section 10 which is coupled to first limb 11 in an integral manner. In addition, second limb 12 is coupled to body section via hinge 52 , while third limb 13 is coupled to body section 10 via hinge 53 . Hinges 52 and 53 can be in the form of any known hinge but in this example show living hinges. Living hinges are hinges that are formed from material that is usually integral with the two components that are hinged. In this case, these hinges 52 and 53 can also have a natural spring incorporated therein based upon the material properties of the living hinge. Therefore, when a user is not pressing down in limbs 11 , 12 and 13 , limbs 12 and 13 would naturally spring away from limb 11 . First limb 11 has tooth 31 at its tip. Second limb 12 has tooth 32 formed at its tip. Third limb 13 has tooth 33 formed at its tip. These teeth can be in any shape but in this case, these teeth are shown ramp shaped. Alternatively, these teeth can be formed as concave having two prongs sticking out from each side. For example, as shown in FIG. 1 , tooth 31 has tooth points or tips 31 . 1 and 31 . 3 and recess point 31 . 2 . Teeth 32 and 33 can be ramp shaped but also be formed as concave shaped teeth shown by the dashed lines. With this design, tooth 32 is formed in a concave manner or in a recessed “V” shape having tooth point 32 . 1 a recess point 32 . 2 , and another tooth point 32 . 3 . Tooth 33 can also optionally be formed with a tooth point 33 . 1 a recess point 32 . 2 and another tooth point 33 . 3 . In addition, in this view, there are a plurality of reinforcing ribs 98 and 99 which essentially criss-cross each other and provide reinforcing support for the body section 10 . In addition, as shown in this view, second limb 12 has a longitudinal axis 104 and a rotational axis 110 while third limb 113 has a longitudinal axis 102 and a rotational axis 108 . Rotational axis 110 is transverse to longitudinal axis 104 , while rotational axis 102 is transverse or normal to rotational axis 108 . (See also FIGS. 9 and 10 ) In addition, while this embodiment shows a device having teeth, teeth in this case are optional and are not required for operation. Therefore, it is clear that this device and therefore the invention can also be implemented without the use of teeth (see dashed lines in FIG. 4 indicating an example of an embodiment with no teeth). While the device can be made from various materials, the most feasible embodiment of the utensil can be made of plastic or other moldable material which is safe for contact with food as a limited use-product via conventional injection molding processes. However, other types of materials can be used such as cornstarch, cardboard, paper, wherein these materials can constitute a more environmentally friendly version. Other alternative materials such as rubber or other types of materials can be used such as a composite material or metal as well. Thus, while the device may be made inexpensively so that it is disposeable, a non-disposable version may be stamped, folded or otherwise forged of metal. An edible version of this product can be made of food matter such as that derived from fibrous vegetables and molded in accordance with this invention and solidified with syrup or other coating such as that derived from oats or honey. FIG. 2 is a perspective, rear view of the utensil of FIG. 1 in the fully open position. This view shows channels which are designed to receive a user's digits Each of these limbs form backside channels allowing a user to insert his or her fingers or digits into these channels to control the manipulation of these limbs 11 , 12 and 13 . This perspective is oriented in such a way so as to be grasped by the viewer with his or her right hand such that the thumb would rest in first finger channel 21 on first limb 11 , the index finger would rest in second finger channel 22 on second limb 12 , and the middle finger of the right hand would rest in third finger channel 23 on third limb 13 . Second limb 12 meets the body of first limb 11 at second limb hinge 52 . Third limb 13 meets the body of first limb 11 at third limb hinge 53 . Channels 21 , 22 and 23 each have two sides and a closed end at the end of the limb opposite the body section 10 . FIG. 3 is a perspective front right-side view of the utensil of FIGS. 1 and 2 compressed to grasp food 2 . The user's hand is implied by the compression on the utensil but is not shown in this figure so as not to obscure the view of the utensil. The food item in this drawing is a chicken leg. This view shows the utensil in such a way that the user has grasped the chicken leg such that the limb teeth 31 , 32 , and 33 are behind the condile or end of the bone at the point of smallest bone diameter so as to minimize the potential for slippage. FIG. 4 is a perspective right side view of the utensil of FIGS. 1 , 2 , and 3 with the user's right hand shown and slightly compressed. Utensil 1 is held by hand 3 such that thumb 41 is in finger channel 21 , second finger 42 is in finger channel 22 of utensil limb 12 , and third finger 43 is in finger channel 23 of utensil limb 13 . This view also shows additional hinges 120 and 130 which are used to create additional bend points in limbs 12 and 13 respectively. FIG. 5 is a front view of a four-limbed version of the utensil constructed in accordance with the invention in a slightly uncompressed position. This version of the utensil has all the elements of the three-limbed version of figures one through four but includes finger channel 24 of fourth-limb 14 with tooth 34 at it's tip. FIG. 6 is a front view of a two-limbed version of the utensil constructed in accordance with the invention in a slightly open position. This version only has first-limb 11 and second-limb 12 with the aforementioned associated teeth and finger channels. Second-limb 12 can be widened to accommodate more than one finger. FIG. 7 is a side view of a two-limbed version of the utensil of FIG. 6 in a slightly open position. This view affords perspective of second-limb hinge 52 which would be the only hinge of this embodiment. Although the first limb is shown with a bend for ergonomics and comfort, any limb can be either straight or curved. FIG. 8 is a side view of a three limbed embodiment which has coil springs which are used as hinges. For example, there are two coil springs 72 and 73 wherein the first coil spring 72 is for second limb 12 and the second coil spring is for third limb 13 . Each of these coil springs is fixed to their respective limbs via retainer pins. For example, spring 72 is secured at one end via second limb channel spring retainer pin 82 . 1 , and at the opposite end via second limb body spring retainer pin 82 . 2 . Spring 73 is secured at one end via third limb channel spring retainer pin 83 . 1 and at the opposite end via third limb body spring retainer pin 83 . 2 . With this embodiment, limb 12 is coupled to body section 10 via a rotational hinge 62 while limb 13 is coupled to body section 10 via rotational hinge 63 . With this design, with the benefit of coil springs, the device can have a snap back action which may be livelier than a living hinge of the other embodiments. In this case the snap back action allows the user to have a different level of feeling and control than with the device shown in FIG. 1 which has living hinges. FIG. 9 is a view of the respective axes of the device wherein there is axis 100 which is the longitudinal axis of first finger 11 . Second finger 12 has a longitudinal axis 104 while third finger has a longitudinal axis 102 . Second finger 12 has a rotational axis 110 while third finger has a rotational axis 108 . As discussed above, rotational axis 110 is transverse or perpendicular to longitudinal axis 104 , while rotational axis 108 is transverse or perpendicular to longitudinal axis 102 . There is also a transverse axis 106 which is transverse to longitudinal axis 100 , this transverse axis 106 shows that axis of rotation 110 and axis of rotation 108 are offset from 90 degrees from longitudinal axis 100 . This offset forms an offset angle 112 between rotational axis 108 and transverse axis 106 and an offset angle 114 between rotational axis 110 and transverse axis 106 . These offset angles are complementary to acute angles 113 and 115 for respective rotational angles 108 and 110 . The offset angles 112 and 114 are set so that second and third limbs 12 and 13 which are latitudinally offset from each other along transverse axis 106 rotate down so that their distal ends, or ends opposite their connection to body 10 , are pressed in contact with each other or adjacent to each other when the device is closed or clamped down thereby creating pressure on a food item in at least a direction shown by arrows 120 and 121 to thereby stabilize the food item against movement via these forces. The food item is also clamped between the limbs via the clamping forces of first limb 11 and second and third limbs 112 and 113 respectively, clamping together as shown in FIG. 10 . FIG. 10 shows a clamped position of the device shown in FIG. 1 . In this case, there is shown second limb 12 and third limb 13 clamped down towards first limb 11 respective channels 22 and 23 for limbs 12 and 13 are also shown. In addition respective teeth 31 , 32 and 33 are also shown for respective limbs 11 , 12 , and 13 . Thus, when a user clamps down on second limb 12 and third limb 13 to draw second limb 12 and third limb 13 towards first limb 11 , second limb 12 and third limb 13 move towards first limb 11 in a first dimension formed for example by arrows 122 , 123 , 124 , and during this movement, second limb 12 and third limb 13 move towards each other as well in a second dimension shown by arrows 120 and 121 . In this view arrows 120 and 121 show the direction of lateral pressure that is applied when the limbs are clamped down. In addition arrows 122 and 123 show the direction of clamping pressure applied when the device is clamped down by a user's fingers. These arrows of pressure represent the helpful pressure that is applied when a user clamps down on the device. Because there are at least three fingers, this type of lateral pressure in the form of arrows 120 and 121 can be applied due to the offset angled settings of rotational axes 108 and 110 . For example arrows 120 and 121 are shown extending substantially perpendicular to arrows 122 and 123 which show the different pressures applied to support food in a usable manner. If pressure was only applied along a single plane or dimension such as in the direction of arrows 122 , 123 and 124 , then this would result in a clumsy handling of food and an unenjoyable experience for the user. In the case of food such as wings, the wings might become unbalanced and slip out of the grip of the user. Thus with the lateral forces applied, the wings or other types of food such as ribs, steak, corn, chicken fingers, shrimp, etc, can be stabilized in a usable manner. Essentially in at least one embodiment there is a food handing device comprising at least three limbs including a first limb 11 for receiving a first finger such as a thumb, a second limb 12 for receiving a second finger such as an index finger, and a third limb 13 for receiving a third finger. There is also at least one body section 10 coupled to each of the first limb 11 , the second limb 12 , and the third limb 13 . Coupled to the body section are at least two hinges 52 and 53 for coupling the second limb 12 and the third limb 13 to body section 10 , wherein these limbs 12 and 13 are independent of each other. These hinges 52 and 53 can be any type of hinges but comprise a first hinge in the form of a living hinge for allowing second limb 12 to be movable about a first rotational axis 110 . There is also a second hinge 53 in the form of a living hinge allowing third limb 13 to be movable about a second rotational axis 108 which extends at a different angle relative to first rotational axis 110 . In this case living hinges are hinges that allow bendable movement of two elements formed essentially integral with each other. In one embodiment second limb 12 has a first end coupled to body section 10 and a second opposite or distal end. Second limb 12 has at least one additional hinge 120 disposed between the first end and the second opposite end, to create an articulating second limb as shown in FIG. 4 . The third limb 13 has a first end coupled to body section 10 and a second opposite end, wherein the third limb 13 has at least one additional hinge 130 disposed between the first end and the second or distal end, to create an articulating third limb 13 . Due to the channels formed in these teeth such as channels 21 , 22 and 23 , these limbs are easily controllable by a user's fingers. FIG. 11 is a modified view of FIG. 4 which discloses the angles of extension of teeth 31 , 32 , and 33 relative to their respective limbs. For example, there is shown longitudinal axis 104 of second limb 12 wherein finger 42 which can be in the form of an index finger extends along this longitudinal axis in the channel for these teeth. Tooth 32 extends out from limb 12 along axis 134 which is offset from axis 135 via offset angle 136 . Axis 135 is transverse or perpendicular to longitudinal axis 104 . Similarly tooth 31 extends out from limb 11 along axis 109 which is offset from axis 107 via offset angle 111 . Axis 107 is perpendicular to longitudinal axis 100 which is the longitudinal axis of limb 11 . In addition, tooth 33 extends out from limb 13 along axis 131 which is offset from axis 132 via offset angle 133 . These offset angles 111 , 133 and 135 are such that it allows the extension of these teeth 31 , 32 , and 33 to extend out away from their respective limbs to allow a clamped down piece of food to be spaced away from a body or limb section of this device. Thus, because of offset angles 111 , 133 , and 136 , the extension axis such as axes 109 , 131 and 134 for each respective tooth 31 , 32 , and 33 intersects a respective longitudinal axis 100 , 104 , and 102 for a respective limb 11 , 12 , and 13 at an acute angle such that each tooth 31 , 32 , and 33 extends out away from each limb 11 , 12 , and 13 to allow a user to grip food in a position away from each limb. Thus, one benefit of these offset extending teeth is that once the piece of food is clamped down upon, the food is spaced away from the body of the device so that a user can easily eat the food. Accordingly, while only a few embodiments of the present invention have been shown and described, it is obvious that many changes and modifications may be made thereunto without departing from the spirit and scope of the invention. REFERENCE SYMBOL LIST 1 utensil/device 2 food 3 hand 5 vertical support member 6 horizontal support member 10 body section 11 first limb 12 second limb 13 third limb 14 fourth limb 21 first finger channel 22 second finger channel 23 third finger channel 24 fourth finger channel 31 first tooth 31 . 1 first tooth point 31 . 2 first tooth recess 31 . 3 first tooth second point 32 second tooth 32 . 1 point 32 . 2 recess point 32 . 3 point 33 third tooth 33 . 1 point 33 . 2 recess point 33 . 3 point 34 fourth tooth 34 . 1 point 34 . 2 recess point 34 . 3 point 41 first finger 42 second finger 43 third finger 44 fourth finger 52 second-limb hinge 53 third-limb hinge 62 second limb rotational coupling 63 third limb rotational coupling 72 second limb coil spring 73 third limb coil spring 82 . 1 second limb channel spring retainer pin 82 . 2 second limb body spring retainer pin 83 . 1 third limb channel spring retainer pin 83 . 2 third limb body spring retainer pin 98 optional reinforcing rib 99 optional reinforcing rib 100 longitudinal axis of first limb 102 longitudinal axis of third limb 104 longitudinal axis of second limb 106 axis transverse to longitudinal axis of first limb 107 axis of extension perpendicular to 108 axis of rotation of third limb 109 axis of extension of first tooth 31 110 axis of rotation of second limb 111 offset angle formed between axis 109 and axis 107 112 offset angle for third limb 114 offset angle for second limb 120 additional hinge for second finger 130 additional hinge for third finger 131 axis of extension of tooth 33 132 axis of extension perpendicular to longitudinal axis 133 offset angle formed between axis 131 and 132 134 axis of extension of tooth 135 axis perpendicular to longitudinal axis 104 136 offset angle formed between axis 134 and axis 135

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of, and claims the benefit of, U.S. non provisional application Ser. No. 12/827,970 filed Jun. 30, 2010, the complete disclosure of which is hereby incorporated herein by reference for all purposes. FIELD OF THE INVENTION [0002] The invention relates generally to liquids such as mouth rinses for the prevention and elimination of bad breath as well as for the reduction of oral microorganisms responsible for the development of dental plaque and tooth decay. In particular, the present invention relates to methods of preparing non-alcohol or reduced alcohol mouth rinses effective at preventing the above-mentioned problems. BACKGROUND OF THE INVENTION [0003] Mouth rinse or mouthwash compositions have been used by people for many years for the prevention of bad breath and for the elimination of bacteria and other oral microorganisms that are responsible not only for bad breath but also tooth decay, plaque and gum diseases such as gingivitis and periodontitis. To this end, antiseptic mouthwashes in the past have been designed to clean the oral cavity, provide fresh breath and kill these pathogenic microbes. [0004] Leading antiseptic mouth rinses have traditionally contained alcohol (i.e., ethanol) at fairly high levels, ranging from approximately 20% up to about 30% by volume, based on the total mouthwash volume (hereinafter referred to as “% v/v”). Alcohol is used both as a vehicle and as a solvent in which the active ingredients, and additives such as astringents, fluorides, color additives, flavor oils, and the like, can be dissolved and then dispersed into solution. Alcohol also provides a preservative role for the mouth rinse during storage and use, and enhances the flavor oil organoleptic cues. [0005] However, the use of high levels of alcohol may sometimes be found unacceptable by some mouthwash users. Senior citizens have also complained about problems related to gargling with such mouth rinses, and chronic exposure has been found to result in a feeling of gum “burn” resulting from the high concentrations of alcohol. It has also been reported that alcoholic mouth rinses can result in an unpleasant “dry mouth” sensation. [0006] On the other hand, reducing the levels of alcohol in these mouth rinse compositions can have significant disadvantages. Such disadvantages include a reduction in the solubility of the mouth rinse actives and/or the other mouth rinse ingredients. [0007] For example, it has been found that lowering alcohol concentration (i.e., replacing the alcohol with water) in commercially available mouth rinse compositions can result in cloudy or turbid compositions. Cloudy or turbid compositions present a clear disadvantage from an aesthetic point of view since clear mouth rinse solutions are certainly more preferred by consumers than cloudy, turbid or otherwise heterogeneous ones. [0008] Additionally, it has been found that lower alcohol concentrations result in a noticeable decrease in the ability of the composition to kill the oral microorganisms responsible for bad breath, plaque and gum disease. This loss in antimicrobial activity is not only due to the reduction of alcohol as a vehicle, but also to the reduced bioavailability of the solubilized actives. [0009] Thymol, for example, is a well known antiseptic compound, also known as an essential oil, which is utilized for its antimicrobial activity in a variety of mouthwash or mouth rinse preparations. In particular, thymol can be utilized in oral hygiene compositions such as mouth rinses in sufficient quantities to provide desired beneficial therapeutic effects. Mouthwashes with thymol are well-known, and have been used by millions of people for over one hundred years. They have been proven effective in killing microbes in the oral cavity that are responsible for plaque, gingivitis and bad breath. Thymol, together with other essential oils such as methyl salicylate, menthol and eucalyptol, comprise the active component in some antiseptic mouth rinses. These oils achieve good efficacy although present in small amounts. Without being restricted to any specific theory, it is now believed that the efficacy and taste of antiseptic mouth rinses may be due to the improved dispersion or dissolution of the oils and bioavailability after such dispersion or dissolution of these four active ingredients. [0010] Obviously then, there is a substantial need for the development of a reduced and/or no alcohol mouth rinses, and methods of producing them or other liquids, which are aesthetically pleasing to consumers and provide improved dispersion or dissolution of the essential oils yet maintain the bioavailability of the essential oils for preventing bad breath, killing oral microbes and reducing or eliminating plaque. [0011] Therefore, an aspect of the present invention is to liquid compositions containing oil or oily components which have reduced turbidity or cloudiness. [0012] Another aspect of the present invention is to provide mouth rinse compositions which are aesthetically pleasing to consumers and provide improved dispersion or dissolution of the essential oils yet maintain the bioavailability of the essential oils for preventing bad breath, killing oral microbes and reducing or eliminating plaque. SUMMARY OF THE INVENTION [0013] In certain embodiments, the present invention relates to methods for preparing a liquid composition or mouth rinse comprising the steps of: a.) preparing a first premix composition comprising: i. a first oil or oily component; ii. optionally, a first polyol solvent, and iii. optionally, a flavor; b.) preparing a second premix composition comprising: i. a second oil or oily component having a degree of hydrophobicity less than the degree of hydrophobicity of the first oil or oily component, and ii. a second polyol solvent; c.) preparing a third premix composition comprising: i. at least one surfactant, and ii. an aqueous phase comprising water; d.) adding the first premix to the third premix; e.) mixing the composition of step d.) until uniform and homogeneous; f) adding the second premix to the composition of step e.) and mixing until uniform and homogeneous; g.) optionally, adding a sugar alcohol solvent; and h.) optionally, mixing the composition of step g.) until uniform and homogeneous. [0029] In certain embodiments, the liquid composition or mouth rinse is a reduced alcohol or non-alcohol composition. [0030] In further embodiments, a method for preparing a reduced alcohol or non-alcohol, antimicrobial mouth rinse composition is disclosed that exhibits a high level of antimicrobial activity as measured by an M-factor greater than 0.5 (or about 0.5), optionally 1.0 (or about 1.0) optionally, 2.0 (or about 2.0), or optionally 3.0 (or about 3.0) where “M-factor” equals the log RLU value of biofilm treated with water used as the negative control minus the log RLU value of biofilm treated with the mouth rinse composition being tested. In addition, the oral mouth rinse compositions of this invention are clear (to the unaided human eye) and aesthetically appealing products. DETAILED DESCRIPTION OF THE INVENTION [0031] The liquid or mouth rinse compositions of the present invention can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well any of the additional or optional ingredients, components, or limitations described herein. The term “comprising” (and its grammatical variations) as used herein is used in the inclusive sense of “having” or “including” and not in the exclusive sense of “consisting only of.” [0032] The terms “a” and “the” as used herein are understood to encompass the plural as well as the singular. [0033] Unless otherwise indicated, all documents cited are, in relevant part, incorporated herein by reference; the citation of any document is not to be construed as an admission that it is prior art with response to the present invention. Furthermore, all documents incorporated herein by reference in their entirety are only incorporated herein to the extent that they are not inconsistent with this specification. [0034] The reduced alcohol or non-alcohol mouthwash and mouth rinse compositions described herein provide an antimicrobially effective amount of one or more antimicrobial essential oils towards oral microorganisms responsible for oral malodor and the build-up of plaque and calculus and the resulting tooth and gum diseases that may follow. [0035] The phrase “antimicrobially effective amount” means the concentration or quantity or level of the compound of the present invention that can attain a particular medical end in having toxic activity for oral microorganisms. [0036] The phrase “orally acceptable” means that the carrier is suitable for application to the surfaces of the oral cavity or ingestion by a living organism including, but not limited to, mammals and humans without undue toxicity, incompatibility, instability, allergic response, and the like. [0037] All percentages, parts and ratios are based upon the total weight of the composition of the present invention, unless otherwise specified. All such weights as they pertain to the listed ingredients are based on the level of the particular ingredient described and, therefore, do not include carriers or by-products that may be included in commercially available materials, unless otherwise specified. [0038] The phrase “reduced alcohol” or “reduced level of alcohol” indicates that the liquid compositions are essentially free of alcohol which means the liquid compositions or mouth rinses of the present invention contain an amount of a C 2 -C 4 monohydric alcohol of up to 10% v/v (or about 10% v/v), optionally, up to 5% v/v (or about 5% v/v), optionally, up to 1.0% v/v (or about 1.0% v/v), optionally up to 0.1% v/v (or about 0.1% v/v) by volume of the total composition. Optionally, the compositions of the present invention are free of C 2 -C 4 monohydric alcohols. [0039] The term “sterile water”, as used herein, means sterile water for irrigation/injection U.S.P. The USP designation means that the sterile water for irrigation/injection is the subject of an official monograph in the current (as of the filing date of this application) US Pharmacopeia. [0040] Unless otherwise specified, the phrase “oil(s) or “oily component(s)” means any hydrophobic, water immiscible compound, including but not limited to, essential oils (such as menthol, thymol, eucalyptol and methyl salicylate), other flavor oils, unsaturated aliphatic long chain alcohols and/or aldehydes such as 1-decen-3-ol; cis-2-nonen-1-ol, trans-2-decenal and mixtures thereof, other hydrophobic compounds such as organic acids, vitamin E, vitamin E acetate, apigenin, triclosan and mixtures thereof and mixtures of any of the above disclosed hydrophobic, water immiscible compounds. [0041] The terms “hydrophobic”, “hydrophobicity” or “degree of hydrophobicity” of an oil or oily component of the present invention or any mixture of such oil or oily components is represented by the Octanol Water Partition Coefficient (K ow ). K ow is the ratio of the concentration by weight of an oil or oily component in the octanol phase and the concentration by weight of the oil or oily component in water phase at equilibrium and at a specified temperature for the biphasic octanol and water system. The logarithm of K ow is called the log P. The experimental values used to calculate the K ow are typically measured at a temperature of between 20° C. to 25° C. [0042] Alternatively, the log P values are conveniently calculated by the “C LOG P” program, also available from Daylight CIS. This program also lists experimental log P values when they are available in the Pomona92 database. The “calculated log P” (C log P) is determined by the fragment approach of Hansch and Leo (cf., A. Leo, in Comprehensive Medicinal Chemistry, Vol. 4, C. Hansch, P. G. Sammens, J. B. Taylor and C. A. Ramsden, Eds., p. 295, Pergamon Press, 1990, incorporated herein by reference). The fragment approach is based on the chemical structure of each oil or oily component, and takes into account the numbers and types of atoms, the atom connectivity, and chemical bonding. The C log P values, which is considered reliable and a widely used estimate for this physicochemical property, can be used instead of the experimental K, method for measuring log P values. [0043] The higher the log P of the oil or oily component, the more hydrophobic (or, the greater the degree of hydrophobicity of) the oil or oily component. [0044] The term “turbidity” as used herein means the cloudiness or haziness of a fluid caused by individual particles (suspended solids or liquids) that are generally invisible to the unaided eye. Fluids can contain suspended solid or liquid matter consisting of varying particle size. While some suspended material will be large enough and heavy enough to settle rapidly to the bottom of the container (or separate into distinct layers) if a liquid sample is left to stand, very small particles will settle (or separate out) only very slowly or not at all if the sample is regularly agitated or the particles are colloidal. These small solid or liquid particles cause the liquid to appear turbid. [0045] One property of such particles is that they will scatter a light beam focused on them. This light scattering effect is considered a good measure of turbidity in water. Turbidity measured this way uses an instrument called a Turbidimeter with the detector setup to the side of the light beam. The more particles floating in water, the more light is scattered toward the detector and the higher the value of detected light. A lower value of detected light indicates a clearer or less cloudy solution. The units of turbidity from a calibrated Turbidimeter are called Nephelometric Turbidity Units (NTUs). A clear formulation is defined as a formulation with an NTU of less than 12 (or about 12). First Premix Composition [0046] The liquid or mouth rinse compositions of the present invention comprise a first premix composition. [0047] In certain embodiments, the first premix composition includes a first oil or oily component and a first polyol solvent. First Oil or Oily Component [0048] The first premix composition of the present invention comprises a first oil or oily component, the first oil or oily component being any oil or oily component or mixture of such oil or oily components. In certain embodiments, the first oil or oily component has a log P of no less than or greater than 2.1 (or about 2.1), optionally 2.2 (or about 2.2). In certain embodiments such as certain mouth rinse embodiments, the first oil or oily component of the present invention comprises at least one antimicrobial essential oil. Antimicrobial Essential Oils [0049] In certain embodiments, the enhanced antimicrobial efficacy of non-alcohol mouth rinse compositions as described herein is attributed to the presence of minor amounts of one or more antimicrobial or bioactive essential oils (i.e. thymol, eucalyptol, menthol and methyl salicylate). [0050] Thymol, [(CH 3 ) 2 CHC 6 H 3 (CH 3 )OH, also known as isopropyl-m-cresol], is only slightly soluble in water but is soluble in alcohol, and its presence is one of the reasons alcohol was necessary in the well-established, high alcohol commercial mouth rinses. Methyl salicylate, [C 6 H 4 OHCOOCH 3 , also known as wintergreen oil], additionally provides flavoring to the together with its antimicrobial function. Eucalyptol (C 10 H 18 O, also known as cineol) is a terpene ether and provides a cooling, spicy taste. Eucalyptol may be used in place of thymol in certain formulations in the same amount if desired. Menthol (CH 3 C 6 H 9 (C 3 H 7 )OH), also known as hexahydrothymol) is also only slightly soluble in alcohol, and is fairly volatile. Menthol, in addition to any antiseptic properties, provides a cooling, tingling sensation. [0051] In certain embodiments, the essential oils are used in amounts effective to provide antimicrobial activity in the oral cavity. In specific embodiments, the total amount of essential oils present in the disclosed compositions can be from 0.001% (or about 0.001%) to 0.35% (or about 0.35%) w/v, or optionally from 0.16% (or about 0.16%) to 0.28% (or about 0.28%) w/v of the composition. [0052] In some embodiments, the compositions of the present invention contain thymol and additionally eucalyptol, menthol, or methyl salicylate, or mixtures thereof. Optionally, the composition contains all four of these essential oils. [0053] In certain embodiments, thymol is employed in amounts of from 0.001% (or about 0.001%) to 0.25% (or about 0.25%) w/v, or optionally from 0.04% (or about 0.04%) to 0.07% (or about 0.07%) w/v of the composition. In certain embodiments, eucalyptol may be employed in amounts of from 0.001% (or about 0.001%) to 0.11% (or about 0.11%) w/v, or optionally from 0.085% (or about 0.085%) to 0.10% (or about 0.10%) w/v of the composition. In certain embodiments, menthol is employed in amounts of from 0.001% (or about 0.001%) to 0.25% (or about 0.25%) w/v, or optionally from 0.035% (or about 0.035%) to 0.05% (or about 0.05%) w/v of the composition. In certain embodiments, methyl salicylate is employed in amounts of from 0.001% (or about 0.001%) to 0.08% (or about 0.08%) w/v, or optionally from 0.04% (or about 0.04%) to 0.07% (or about 0.07%) w/v of the composition. [0054] In some embodiments, the carrier for the essential oils (the active ingredients) is typically a water-alcohol mixture, generally water-ethanol. In the past, some antiseptic oral mouth rinse compositions, required ethanol levels of up to about 27% v/v. These high levels were necessary to assist the actives in providing the necessary antimicrobial functionality as well as providing a clear, aesthetically attractive liquid medium. Merely reducing the alcohol levels, without the addition of other formulation components, results in a cloudy, less efficacious product. [0055] Without being bound to any theory, it is believed that in these high alcohol level oral compositions, the alcohol solubilizes the antimicrobial essential oils and in so doing acts to keep the essential oils bioactive. The antimicrobial essential oils are more readily dispersed throughout the solution and remain free or unbound to attack pathogenic microbes throughout the oral cavity. Reducing the alcohol levels was believed to adversely affect this enhancement mechanism. In accordance with the present invention, however, it was surprisingly and unexpectedly found that the level of alcohol can be reduced or eliminated without sacrificing antimicrobial efficacy or clarity if the mouth rinse composition contains a solvent system and surfactants as taught herein. First Polyol Solvent [0056] In certain embodiments, a first polyol solvent is added to the first premix composition. The first polyol solvent comprises a polyol or polyhydric alcohol selected from the group consisting of polyhydric alkanes (such as propylene glycol, glycerin, butylene glycol, hexylene glycol, 1,3-propanediol); polyhydric alkane esters (dipropylene glycol, ethoxydiglycol); polyalkene glycols (such as polyethylene glycol, polypropylene glycol) and mixtures thereof. In certain embodiments, the polyol solvent can be present in an amount of from 0% to 20.0% (or about 20.0%) w/v, optionally from 1.0% (or about 1.0%) to 15.0% (or about 15.0%) w/v, or optionally from 2.5% (or about 2.5%) to 8.0% (or about 8.0%) w/v of the composition. Flavors or Flavorants [0057] In certain embodiments, the first premix composition further comprises flavors or flavorants may to modify or magnify the taste of the liquid composition or mouth rinse, or reduce or mask the sharp “bite” or “burn” of ingredients such as thymol. Suitable flavors include, but are not limited to, oil of anise, anethole, benzyl alcohol, spearmint oil, citrus oils, vanillin and the like may be incorporated. In these embodiments, the amount of flavor oil added to the composition can be from 0.001% (or about 0.001%) to 1.0% (or about 1.0%) w/v, or optionally from 0.01% (or about 0.010%) to 0.30% (or about 0.30%) w/v of the total composition. [0058] The particular flavors or flavorants, and other taste-improving ingredients, employed will vary depending upon the particular taste and feel desired. Those skilled in the art can select and customize these types of ingredients to provide the desired results. Second Premix Composition [0059] The compositions of the present invention further comprise a second premix composition. [0060] In certain embodiments, the second premix composition comprises a water insoluble component and a second solvent or solvent system comprising, consisting of or consisting essentially of at least one polyol solvent. Second Oil or Oily Component [0061] The second premix composition of the present invention comprises a second oil or oily component, the second oil or oily component being any oil or oily component or mixture of such oil or oily components such that the hydrophobicity (or degree of hydrophobicity) of the second oil or oily component is less than the hydrophobicity (or degree of hydrophobicity) of the first oil or oily component. In certain embodiments, the second oil or oily component has a log P of no more than or less than 2.1 (or about 2.1), optionally 2.0 (or about 2.0). In certain embodiments, the second oil or oily component of the present invention is or comprises at least one organic acid. In certain embodiments, the organic acid is used as a buffer or part of a buffering system. Organic Acid [0062] Organic acids suitable for use in the compositions of the present invention include, but are not limited to, ascorbic acid, sorbic acid, citric acid, glycolic acid, lactic acid and acetic acid, benzoic acid, salicylic acid, phthalic acid, phenolsulphonic acid, succinic acid and mixtures thereof, optionally, the organic acid is selected from the group consisting of benzoic acid, sorbic acid, succinic acid, citric acid and mixtures thereof, or optionally, the organic acid is benzoic acid. In certain embodiment, the organic acid buffer is present in amounts of from 0.001% (or about 0.001% w/v) to 1.0% w/v (or about 1.0% w/v) of the composition. [0063] When used as buffers or as part of a buffering system, the organic acids are incorporated in amounts that maintain the pH at levels of from 3.0 (or about 3.0) to 8.0 (or about 8.0), optionally from 3.5 (or about 3.5) to 6.5 (or about 6.5), optionally from 3.5 (or about 3.5) to 5.0 (or about 5.0). Without being limited any theory, it is believed that these pH levels provide the essential oils with an environment that also maximizes their antimicrobial activity and promotes stability. [0064] In certain embodiments, the total amount of any oil or oily components present in the disclosed compositions of the present invention should not exceed 1.35% w/v (or about 1.35% w/v) of the total composition. Optionally, the total of all oil or oily components, can be present in an amount of from 0.04% (or about 0.04%) to 1.35% (or about 1.35%) w/v, or optionally from 0.10% (or about 0.10%) to 0.4% (or about 0.4%) w/v of the total composition. Second Polyol Solvent [0065] A second polyol solvent is added to the second premix. In certain embodiments, the second polyol solvent can be the same as or different from the first polyol solvent and comprises a polyol or polyhydric alcohol selected from the group consisting of polyhydric alkanes (such as propylene glycol, glycerin, butylene glycol, hexylene glycol, 1,3-propanediol); polyhydric alkane esters (dipropylene glycol, ethoxydiglycol); polyalkene glycols (such as polyethylene glycol, polypropylene glycol) and mixtures thereof. In certain embodiments, the polyol solvent can be present in an amount of from 1% (or about 1%) to 15.0% (or about 15.0%) w/v, or optionally from 2.5% (or about 2.5%) to 8.0% (or about 8.0%) w/v of the composition. [0066] In certain embodiments, where a first polyol solvent is not added to the first premix, the second polyol solvent can be present in an amount of from 1.0% (or about 1.0%) to 30.0% (or about 30.0%) w/v, or optionally from 5.0% (or about 5.0%) to 15.0% (or about 15.0%) w/v of the composition. Third Premix Composition [0067] The compositions of the present invention further comprise a third premix composition. In certain embodiments, the third premix composition comprises a surfactant and in an aqueous phase. Surfactant [0068] Suitable examples of surfactants useful in the compositions of the present invention include anionic surfactants, nonionic surfactants, amphoteric surfactants and mixtures thereof. [0069] Anionic surfactants useful herein include, but are not limited to, sarcosine type surfactants or sarcosinates; taurates such as sodium methyl cocoyl taurate; alkyl sulfates such as sodium trideceth sulfate or sodium lauryl sulfate; sodium lauryl sulfoacetate; sodium lauroyl isethionate; sodium laureth carboxylate; sodium dodecyl benzenesulfonate and mixtures thereof. Many suitable anionic surfactants are disclosed in U.S. Pat. No. 3,959, 458, to Agricola, et al., herein incorporated by reference in its entirety. [0070] Nonionic surfactants which can be used in the compositions of the present invention include, but are not limited to, compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound which may be aliphatic or alkyl-aromatic in nature. Examples of suitable nonionic surfactants include, but are not limited to, alkyl polyglucosides; block copolymers such as ethylene oxide and propylene oxide copolymers e.g. Poloxamers; ethoxylated hydrogenated castor oils available commercially for example under the trade name CRODURET (Croda Inc., Edison, N.J.); Alkyl polyethylene oxide e.g. Polysorbates, and/or; fatty alcohol ethoxylates; polyethylene oxide condensates of alkyl phenols; products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine; ethylene oxide condensates of aliphatic alcohols; long chain tertiary amine oxides; long chain tertiary phosphine oxides; long chain dialkyl sulfoxides; and mixtures thereof. [0071] The amphoteric surfactants useful in the present invention include, but are not limited to, derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be a straight chain or branched and wherein one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and one contains an anionic water-solubilizing group, e.g., carboxylate, sulfonate, sulfate, phosphate, or phosphonate. Examples of suitable amphoteric surfactants include, but are not limited alkylimino-diproprionates, alkylamphoglycinates (mono or di), alkylamphoproprionates (mono or di), alkylamphoacetates (mono or di), N-alkyl β-aminoproprionic acids, alkylpolyamino carboxylates, phosphorylated imidazolines, alkyl betaines, alkylamido betaines, alkylamidopropyl betaines, alkyl sultaines, alkylamido sultaines, and mixtures thereof. In certain embodiments, the amphoteric surfactant is selected from the group consisting of alkylamidopropyl betaines, amphoacetates such as sodium lauroamphoacetate and mixtures thereof. Mixtures of any of the above mentioned surfactants can also be employed. A more detailed discussion of anionic, nonionic and amphoteric surfactants can be found in U.S. Pat. Nos. 7,087,650 to Lennon; U.S. Pat. No. 7,084,104 to Martin et al.; U.S. Pat. No. 5,190,747 to Sekiguchi et al.; and U.S. Pat. No. 4,051,234, Gieske, et al., each of which patents are herein incorporated by reference in their entirety. [0072] In certain embodiments, the liquid or mouth rinse compositions contain at least one alkyl sulfate surfactant either alone or in addition to at least one of the other above mentioned surfactants. In certain embodiments, suitable alkyl sulfate surfactants include, but are not limited to sulfated C 8 to C 18 , optionally sulfated C 10 to C 16 even numbered carbon chain length alcohols neutralized with a suitable basic salt such as sodium carbonate or sodium hydroxide and mixtures thereof such that the alkyl sulfate surfactant has an even numbered C 8 to C 18 , optionally C 10 to C 16 , chain length. In certain embodiments, the alkyl sulfate is selected from the group consisting of sodium lauryl sulfate, hexadecyl sulfate and mixtures thereof. In certain embodiments, commercially available mixtures of alkyl sulfates are used. A typical percentage breakdown of alkyl sulfates by alkyl chain length in commercially available sodium lauryl sulfate (SLS) is as follows: [0000] Alkyl Chain Component Length Percentage in SLS C 12 >60% C 14 20%-35% C 16 <10% C 10  <1% C 18  <1% [0073] Suitable commercially available mixtures include Stepanol WA-100 NF USP, (Stepan, Northfield, Ill.), Texapon K12 G PH, (Texapon, Cognis, Germany) and mixtures thereof. [0074] In certain embodiments, the amount of the alkyl sulfate surfactant added to the composition can be from 0.05% (or about 0.05%) to 2.0% (or about 2.0%) w/v, or optionally from 0.1% (or about 0.1%) to 0.5% (or about 0.5%) w/v of the composition. [0075] The total surfactant concentration should not exceed or should be less than 2% (or about 2%), optionally, the total surfactant concentration should not should not exceed or should be less than 1.5% (or about 1.5%), optionally, the total surfactant concentration should not should not exceed or should be less than 1.0% (or about 1.0%, optionally, the total surfactant concentration should not should not exceed or should be less than 0.5% (or about 0.5%). Aqueous Phase [0076] The first premix and the second premix are added to an aqueous phase comprising water to form oil-in-water or water-in-oil dispersions, micro emulsions or emulsions. [0077] In certain embodiments, the aqueous phase comprises from about 60% to about 95%, or optionally from about 75% to about 93%, by weight of the composition. [0078] Alternatively, the liquid or mouth rinse compositions of the present invention may be formulated in a dry powder, chewing gum, semi-solid, solid or liquid concentrate form. In such embodiments, for example, water is added to q.s. as necessary in the case of liquid concentrates or powdered formulations, or water may be removed using standard evaporation procedures known in the art to produce a composition in dry powder form. Evaporated, or freeze dried forms are advantageous for storage and shipping. Sugar Alcohol Solvent [0079] In certain embodiments, a sugar alcohol is also added to the liquid or mouth rinse compositions of the present invention. The sugar alcohol solvent(s) may be selected from those multi-hydroxy-functional compounds that are conventionally used in oral and ingestible products. In certain embodiments, the sugar alcohol(s) should be non-metabolized and non-fermentable sugar alcohol(s). In specific embodiments, the sugar alcohols include, but are not limited to sorbitol, xylitol, mannitol, maltitol, inositol, allitol, altritol, dulcitol, galactitol, glucitol, hexitol, iditol, pentitol, ribitol, erythritol and mixtures thereof. Optionally, the sugar alcohol is selected from the group consisting of sorbitol and xylitol or mixtures thereof. Optionally, the sugar alcohol is sorbitol. [0080] In certain embodiments, the total amount of sugar alcohol(s), which are added to effectively aid in the dispersion or dissolution of the mouth rinse or other ingredients, should not exceed 20% w/v (or about 20% w/v) of the total composition. Optionally, total amount of sugar alcohol should not exceed 17% w/v (or about 17% w/v) of the total composition. Optionally, total amount of sugar alcohol should not exceed 10% w/v (or about 10% w/v) of the total composition. The sugar alcohol can be in an amount of from 1.0% (or about 1.0%) to 20.0% (or about 20.0%) w/v, optionally from 2.5% (or about 2.5%) to 17.0% (or about 17.0%) w/v, or optionally from 5.0% (or about 5.0%) to 15.0% (or about 15.0%) w/v of the total composition. [0081] In certain embodiments, the ratio of the sugar alcohol to the total polyol solvent component in the composition should be from 10:1 (or about 10:10) to 1:10 (or about 1:10), optionally from 5:1 (or about 5:1) to 1:5 (or about 1:5), optionally 1:1 (or about 1:1) by weight. [0082] In certain embodiments, the total amount of the solvent, including all polyol solvents and all sugar alcohol solvents, which is added to effectively aid in the dissolution or dispersion of the mouth rinse or other ingredients, should not exceed 47% w/v (or about 47% w/v) of the total composition. Optionally, total amount of solvent system should not exceed 20% w/v (or about 20% w/v) of the total composition. The solvent system can be in an amount of from 2% (or about 2%) to 47% (or about 47%) w/v, or optionally from 10% (or about 10%) to 20% (or about 20%) w/v of the total composition. [0083] In certain embodiments, the ratio of the total solvent (i.e., polyol solvent and the sugar alcohol solvent) to the total surfactant in the composition should be from 360:1 (or about 360:1) to 10:1 (or about 10:1), optionally from 100:1 (or about 100:1) to 20:1 (or about 20:1) by weight. Method of Manufacturing [0084] Each of the above premixes is mixed until uniform and homogeneous. Once each premix is mixed until uniform and homogeneous, the first premix is added to the third premix and mixed until uniform and homogeneous. Once the mixture of the first premix and third premix are mixed until uniform and homogeneous, the second premix is added to the mixture of the first premix and third premix and mixed until uniform and homogeneous. [0085] Without being limited by theory, it is believed that first oil or oily component and the second oil or oily component compete for the surfactant and solvents in the aqueous phase of the present invention. By first mixing the first oil or oily component of higher degree of hydrophobicity as a polyol solvent premix with an aqueous phase containing surfactant before adding a polyol solvent premix of the second oil or oily component of lower degree of hydrophobicity to the aqueous phase containing surfactant, the first oil or oily component of higher degree of hydrophobicity is mixed with the surfactant and/or solvent to achieve the dispersion and/or dissolution in the aqueous phase required to produce compositions having a turbidity of less than 12 (or about 12) Nephelometric Turbidity Units (NTUs). The turbidity of the liquid composition or mouth rinse is further reduced by adding any sugar alcohol solvents after the first and second oil or oily components have been added to an aqueous phase. [0086] In certain embodiments, the liquid or mouth rinse compositions of the present invention have NTU values of less than 10 (or about 10), optionally 8 (or about 8), optionally 6 (or about 6), or optionally 4 (or about 4). Optional Ingredients Insoluble Particulates [0087] In certain embodiments, the oral care compositions of the present invention optionally comprise a safe and effective amount of a water insoluble particulate. The water insoluble particulate can be an abrasive particle (such as a dentally acceptable abrasive) or non-abrasive particulate. [0088] In certain embodiments, dentally acceptable abrasives include, but are not limited to, water insoluble calcium salts such as calcium carbonate, and various calcium phosphates, alumina, silica, synthetic resins and mixtures thereof. Suitable dentally acceptable abrasives may generally be defined as those having a radioactive dentine abrasion value (RDA) of from about 30 to about 250 at the concentrations used in the compositions of the present invention. In certain embodiments, abrasives are non-crystalline, hydrated, silica abrasives, particularly in the form of precipitated silica or milled silica gels available commercially, for example, under the trade names ZEODENT (J. M. Huber Corporation, Edison, N.J.), and SYLODENT (W.R. Grace & Co., New York, N.Y.), respectively. In certain embodiments, the compositions according to the present invention comprise from about 1% to about 20%, or, optionally, from about 5% to about 10% by weight of the abrasive. [0089] Alternatively, the insoluble particulate is a non-abrasive particulate which is visible to the unaided eye and stable in the compositions of the present invention. [0090] The non-abrasive particulate can be of any size, shape, or color, according to the desired characteristic of the product. The non-abrasive particulates will typically have the shape of a small round or substantially round ball or sphere, however, platelet or rod-shaped configurations are also contemplated herein. Generally, a non-abrasive particulate has an average diameter of from about 50 μm to about 5000 μm, optionally from about 100 μm to about 3000 μm, or optionally from about 300 μm to about 1000 μm. By the terms “stable” and/or “stability”, it is meant that the abrasive or non-abrasive particulates are not disintegrated, agglomerated, or separated under normal shelf conditions. In certain embodiments, the terms “stable” and/or “stability” further mean that the compositions of present invention contain no visible or minimally visible (to the unaided eye) signs of sedimentation of the insoluble particulates after 8 weeks, optionally 26 weeks, optionally 52 weeks, at room temperature. [0091] The non-abrasive particulates herein are typically incorporated in the present compositions at levels of from about 0.01% to about 25%, optionally, from about 0.01% to about 5%, or optionally, from about 0.05% to about 3%, by weight of the composition. [0092] The non-abrasive particulate herein will typically comprise a structural material and/or, optionally, an encompassed material. [0093] The structural material provides a certain strength to the non-abrasive particulates so that they retain their distinctively detectable structure in the compositions of the present invention under normal shelf conditions. In one embodiment, the structural material further can be broken and disintegrated with very little shear on the teeth, tongue or oral mucosa upon use. [0094] The non-abrasive particulates can be solid or liquid, filled or un-filled, as long as they are stable in the compositions of the present invention. The structural material used for making the non-abrasive particulates varies depending on the compatibility with other components, as well as material, if any, to be encompassed in the non-abrasive particulates. Exemplary materials for making the non-abrasive particulates herein include: polysaccharide and saccharide derivatives such as crystalline cellulose, cellulose acetate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose nitrate, ethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxypropylmethylcellulose phthalate, methyl cellulose, sodium carboxymethylcellulose, gum acacia (gum arabic), agar, agarose, maltodextrin, sodium alginate, calcium alginate, dextran, starch, galactose, glucosamine, cyclodextrin, chitin, amylose, amylopectin, glycogen, laminaran, lichenan, curdlan, inulin, levan, pectin, mannan, xylan, alginic acid, arabic acid, glucommannan, agarose, agaropectin, prophyran, carrageenen, fucoidan, glycosaminoglycan, hyaluronic acid, chondroitin, peptidoglycan, lipopolysaccharide, guar gum, starch, and starch derivatives; oligosaccharides such as sucrose, lactose, maltose, uronic acid, muramic acid, cellobiose, isomaltose, planteose, melezitose, gentianose, maltotriose, stachyose, glucoside and polyglucoside; monosaccharides such as glucose, fructose, and mannose; synthetic polymers such as acrylic polymers and copolymers including polyacrylamide, poly(alkyl cyanoacrylate), and poly(ethylene-vinyl acetate), and carboxyvinyl polymer, polyamide, poly(methyl vinyl ether-maleic anhydride), poly(adipyl-L-lysine), polycarbonate, polyterephthalamide, polyvinyl acetate phthalate, poly(terephthaloyl-L-lysine), polyarylsulfone, poly(methylmethacrylate), allyl methacrylate, poly(8-caprolactone), polyvinylpyrrolidone, polydimethylsiloxane, polyoxyethylene, polyester, polyglycolic acid, polylactic acid, polyglutamic acid, polylysine, polystyrene, poly(styrene-acrylonitrile), polyimide, and poly(vinyl alcohol); and other material such as fat, fatty acid, fatty alcohol, milk solids, molasses, gelatin, gluten, albumin, shellac, caseinate, bees wax, carnauba wax, spermaceti wax, hydrogenated tallow, glycerol monopalmitate, glycerol dipalmitate, hydrogenated castor oil, glycerol monostearate, glycerol distearate, glycerol tristearate, 12-hydroxystearyl alcohol, protein, and protein derivatives; and mixtures thereof. Components herein may be described in other sections as useful components for the present composition. In certain embodiments, the components as described in this section form the structure of the non-abrasive particulates so as to not be substantially dissolved or dispersed from the particulates and into the compositions of the present invention under normal shelf conditions. [0095] In other embodiments, the structural material herein comprises components selected from the group consisting of polysaccharides and their derivatives, saccharides and their derivatives, oligosaccharides, monosaccharides, and mixtures thereof, or optionally, comprises components are having various degrees of water solubility. In some embodiments, the structural material comprises lactose, cellulose, and hydroxypropyl methylcellulose. [0096] Suitable non-abrasive particulates also include organogel particles as described in detail in U.S. Pat. No. 6,797,683. Non-abrasive particulates that are organogel particles typically comprise a structural material selected from waxes (e.g., beeswax, paraffin, water-insoluble wax, carbon-based wax, silicone wax, microcrystalline wax, etc.), triglycerides, acid triglycerides, polymers, fluoroalkyl (meth)acrylate polymers and copolymers, acrylate polymers, ethylene/acrylate copolymers, polyethylene, polypropylene polymers and copolymers, fatty acids, fatty alcohols, fatty acid esters, fatty acid ethers, fatty acid amides, alkylene polyhydric alcohols, fatty acid amide of an alkanolamine, glyceryl monostearate, (aryl-substituted)sugars, dibenzyl sorbitol (or mannitoal, rabbitol, etc.), condensates and precondensates of lower monohydric alcohols, trihydroic alcohols, lower polyglycols, propylene/ethylene polycondensates, and the like. Optionally, structural material for non-abrasive particulates that are organogel particles include beeswax, carnauba wax, low molecular weight ethylene homopolymers (e.g. Polywax 500, Polywax 1000, or Polywax 2000 polyethylene materials available from Baker Petrolite Corp.), or paraffin wax. [0097] The non-abrasive particulates herein may encompass, contain, or be filled with an encompassed material. Such encompassed material can be water soluble or water insoluble. Suitable encompassed materials include benefit agents as described herein such as: oral care actives, vitamins, pigments, dyes, antimicrobial agents, chelating agents, optical brighteners, flavors, perfumes, humectants, minerals, and mixtures thereof. The encompassed materials herein are substantially retained within the non-abrasive particulates, and are substantially not dissolved from the particulates and into the compositions of the present composition under normal shelf conditions. [0098] Particularly useful commercially available non-abrasive particulates herein are those with tradenames Unisphere and Unicerin available from Induchem AG (Switzerland), and Confetti Dermal Essentials available from United-Guardian Inc. (NY, USA). Unisphere and Unicerin particles are made of microcrystalline cellulose, hydroxypropyl cellulose, lactose, vitamins, pigments, and proteins. Upon use, the Unisphere and Unicerin particles can be disintegrated with very little shear and with practically no resistance, and readily disperse in the compositions of the present invention. [0099] Suitable non-abrasive particulates for incorporation in the present compositions are described in detail in U.S. Pat. No. 6,797,683 (organogel particles); U.S. Pat. No. 6,045,813 (rupturable beads); U.S. 2004/0047822 A1 (visible capsules); and U.S. Pat. No. 6,106,815 (capsulated or particulated oily substances), each of which patent documents are herein incorporated by reference in their entirety. [0100] In certain embodiments, the abrasive and/or nonabrasive particles have a density different or, optionally, substantially different from the carrier in which these particles are formulated. Fluoride Releasing Compounds [0101] In certain embodiments, fluoride providing compounds may be present in the mouth rinse compositions of this invention. These compounds may be slightly water soluble or may be fully water soluble and are characterized by their ability to release fluoride ions or fluoride containing ions in water. Typical fluoride providing compounds are inorganic fluoride salts such as soluble alkali metal, alkaline earth metal, and heavy metal salts, for example, sodium fluoride, potassium fluoride, ammonium fluoride, cupric fluoride, zinc fluoride, stannic fluoride, stannous fluoride, barium fluoride, sodium hexafluorosilicate, ammonium hexafluorosilicate, sodium fluorozirconate, sodium monofluorophosphate, aluminum mono-and difluorophosphate and fluorinated sodium calcium pyrophosphate. Amine fluorides, such as N′-octadecyltrimethylendiamine-N,N,N′- tris(2-ethanol)-dihydrofluoride and 9-octadecenylamine-hydrofluoride), may also be used. [0102] In certain embodiments, the fluoride providing compound is generally present in an amount sufficient to release up to 0.15% (or about 0.15%), optionally 0.001% (or about 0.001%) to 0.1% (or about 0.1%), optionally from 0.001% (or about 0.001%) to 0.05% (or about 0.05%) fluoride by weight of the composition. Zinc Salts [0103] In certain embodiments, zinc salts such as zinc chloride, zinc acetate or zinc citrate may be added as an astringent for an “antiseptic cleaning” feeling, as a breath protection enhancer or as anticalculus agent in an amount of from 0.0025% w/v (or about 0.0025% w/v) to 0.1% w/v (or about 0.1% w/v) of the composition. Sensitivity Reducing Agents [0104] In certain embodiments, sensitivity reducing agents, namely potassium salts of nitrate and oxalate in an amount from 0.1% (or about 0.1%) to 5.0% (or about 5.0%) w/v of the composition may be incorporated into the present invention. Other potassium releasing compounds are feasible (e.g. KCl). High concentrations of calcium phosphates may also provide some added sensitivity relief. These agents are believed to work by either forming an occlusive surface mineral deposit on the tooth surface or through providing potassium to the nerves within the teeth to depolarize the nerves. A more detailed discussion of suitable sensitivity reducing can be found in US 20060013778 to Hodosh and U.S. Pat. No. 6,416,745 to Markowitz et al., both of which are herein incorporated by reference in their entirety. Anticalculus Agents [0105] In certain embodiments, compounds with anti-calculus benefits (e.g. polyphosphates, phosphonates, various carboxylates, polyaspartic acid, inositol phosphate etc.) may be incorporated into the present invention. Also useful as an anticalculus agent are the anionic polymeric polycarboxylates. Such materials are well known in the art, being employed in the form of their free acids or partially or preferably fully neutralized water soluble alkali metal (e.g. potassium and preferably sodium) or ammonium salts. Preferred are 1:4 to 4:1 by weight copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether (methoxyethylene) having a molecular weight (M.W.) of about 30,000 to about 1,000,000. These copolymers are available for example as Gantrez AN 139 (M.W. 500,000), AN 119 (M.W. 250,000) and preferably S-97 Pharmaceutical Grade (M.W. 70,000), of GAF Chemicals Corporation. Additional Ingredients [0106] Although the liquid or mouth rinse compositions of the present invention may be formulated to be substantially clear and/or colorless to the unaided eye, acceptably approved food dyes are preferably used to provide a pleasing color to the compositions of the invention. These may be selected from, but not limited to, the long list of acceptable food dyes. Suitable dyes for this purpose include FD&C yellow #5, FD&C yellow #10, FD&C blue #1 and FD&C green #3. These are added in conventional amounts, typically in individual amounts of from 0.00001% w/v (or about 0.00001% w/v) to 0.0008% w/v (or about 0.0008% w/v), optionally from 0.00035% w/v (or about 0.00035% w/v) to 0.0005% w/v (or about 0.0005% w/v) of the composition. [0107] Other conventional ingredients may be used in the liquid or mouth rinse compositions of this invention, including those known and used in the art. Examples of such ingredients include thickeners, suspending agents and softeners. Thickeners and suspending agents useful in the compositions of the present invention can be found in U.S. Pat. No. 5,328,682 to Pullen et al., herein incorporated by reference in its entirety. In certain embodiments, these are incorporated in amounts of from 0.1% w/v (about 0.1% w/v) to 0.6% w/v (or about 0.6% w/v), optionally 0.5% w/v (or about 0.5% w/v) of the composition. [0108] A more detailed description of useful oral care actives and/or inactive ingredients and further examples thereof can be found in U.S. Pat. No. 6,682,722 to Majeti et al. and U.S. Pat. No. 6,121,315 to Nair et al., each of which are herein incorporated by reference in its entirety. [0109] In certain embodiments, the compositions of the present invention are free of or essentially free of bioavailability affecting compounds. As used herein, “bioavailability affecting compound”, means compounds that negatively affect the bioavailability of any incorporated essential oils such as by binding the essential oils or otherwise inactivating the essential oils. “Essentially free” as used with respect to bioavailability affecting compounds is defined as formulations having less than 5% (or about 5%), optionally, 3% (or about 3%), optionally, 1% (or about 1%), or optionally 0.1, or optionally, 0.01% (or about 0.01%), by weight (w/v) of the total composition of a bioavailability affecting compound. In certain embodiments, the bioavailability affecting compound can include, but is not limited to, polyethylene oxide/polypropylene oxide block copolymers such as poloxamers; cyclodextrins; polysorbates such as Tweens; and mixtures thereof. Methods of Practicing the Present Invention [0110] The invention illustratively disclosed herein may be practiced in the absence of any component, ingredient, or step which is not specifically disclosed herein. [0111] In certain embodiments, the compositions of the present invention are applied to teeth and/or soft surfaces of the oral cavity for at least two consecutive applications, optionally, at least (or greater than) 3 (or about 3) or optionally, at least (or greater than) 5 (or about 5) consecutive applications. [0112] When applied to teeth and/or soft surfaces of the oral cavity, in certain embodiments, the composition is allowed to remain in contact with the teeth and/or soft surfaces of the oral cavity for at least (or greater than) 10 (or about 10) seconds, optionally 20 (or about 20) seconds, optionally 30 (or about 30) seconds, optionally 50 (or about 50) seconds, or optionally 60 (or about 60) seconds. [0113] Various embodiments of the invention have been set forth above. Each embodiment is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment, can be used on another embodiment to yield a still further embodiment. Thus, it is intended that the present invention cover such modifications and variations as come within the scope of the appended claims and their equivalents. EXAMPLES [0114] The following examples are illustrative only and should not be construed as limiting the invention in any way. Those skilled in the art will appreciate that variations are possible which are within the spirit and scope of the appended claims. Example 1 Effect of Various Methods of Forming Formulations, and Increasing Surfactant Levels [0115] Nine propylene-glycol based mouth rinse formulations were prepared by a variety of methods using various surfactants that are approved for use in oral care products. The formulations were tested for turbidity and antimicrobial activity. Turbidity was tested using a Laboratory Turbidimeter Model 2100N from Hach Company (Loveland, Colo.). The formulations were also tested using an in-vitro single species S. mutans biofilm model. A 22-hour S. mutans biofilm was grown (N=96) and exposed to the formulations as well as positive and negative controls for 30 seconds. Sterile water was used as the negative control. After treatment the biofilm was neutralized and rinsed. The biofilm was harvested via sonication using a Misonix XL-2000 Ultrasonic processor (Qsonica, LLC, Newtown, Conn.). Using a Celsis Rapid Detection RapiScreen kit (Celsis International PLC, Chicago). The bacteria was lysed with Celsis Luminex and the ATP from the bacteria was measured using the bioluminescence marker Celsis LuminATE. Decreasing log RLUs (relative light units) indicates fewer bacteria alive after treatment. The nine formulations are shown on Table 1. Final formulations were adjusted to pH 4.2 with 0.1M NaOH or 0.1M HCl if necessary. [0000] TABLE 1 Formulations 1A 1B 1C 1D 1E 1F 1G 1H 1I Negative Ingredients (% w/w) (% w/w) (% w/w) (% w/w) (% w/w) (% w/w) (% w/w) (% w/w) (% w/w) Control Propylene glycol 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 — USP L-Menthol USP 0.0413 0.0413 0.0413 0.0413 0.0413 0.0413 0.0413 0.0413 0.0413 — Thymol NF 0.0620 0.0620 0.0620 0.0620 0.0620 0.0620 0.0620 0.0620 0.0620 — Methyl salicylate 0.0641 0.0641 0.0641 0.0641 0.0641 0.0641 0.0641 0.0641 0.0641 — NF Eucalyptol USP 0.0895 0.0895 0.0895 0.0895 0.0895 0.0895 0.0895 0.0895 0.0895 — Flavor 0.1000 0.1000 0.1000 0.1000 0.1000 0.1000 0.1000 0.1000 0.1000 — Sorbitol (70% 10.000 10.000 10.000 10.000 10.000 10.000 10.000 10.000 10.000 — solution) USP Sodium Lauryl 0.3150 0.3150 0.3150 — — 0.3150 0.3150 0.3150 0.3150 — Sulfate USP Poloxamer 407 NF — — — 2.0000 — — — — — — Tween 20 — — — — 2.0000 — — — — — Sodium Saccharin 0.0606 0.0606 0.0606 0.0606 0.0606 0.0606 0.0606 0.0606 0.0606 — USP Sucralose NF 0.0100 0.0100 0.0100 0.0100 0.0100 0.0100 0.0100 0.0100 0.0100 — Benzoic Acid USP 0.0859 0.0859 0.0859 0.0859 0.0859 0.0859 0.0859 0.0859 0.0859 — Sodium Benzoate 0.0773 0.0773 0.0773 0.0773 0.0773 0.0773 0.0773 0.0773 0.0773 — NF FD&C Green #3 0.00002 0.00002 0.00002 0.00002 0.00002 0.00002 0.00002 0.00002 0.00002 — Purified Water USP QS QS QS QS QS QS QS QS QS — TOTAL 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 — log RLU 6.01 5.46 5.45 7.64 7.68 5.49 5.62 5.52 5.55 7.67 M-factor 1.66 2.21 2.22 0.03 −0.01 2.18 2.05 2.15 2.12 0 Turbidity (NTU) 11.4 13.3 12.8 10.7 2.22 16.1 3.93 15.9 17.2 [0116] The procedure for mixing the formulations was as follows: [0117] Formulation 1A: The water was put in an appropriately sized tank (or vessel), then all remaining ingredients were added to the water and mixed until dispersed. No separate premixes were formed. [0118] Formulation 1B: In step 1, the polyol solvent (i.e., propylene glycol) was put in an appropriately sized tank (or vessel). The active oils and flavor were added to the polyol solvent in the tank and mixed until homogeneous and uniform to form a premix. In step 2, instead of adding as the final component in the final step of the formulation process, the sugar alcohol was added to the premix and mixed until the formulation was homogeneous and uniform before adding the surfactant, water, organic acid buffer, preservative, sweeteners and dyes. In step 3, the surfactant was added to the premix and mixed until the formulation was homogeneous and uniform. In step 4, the water was added to the premix and mixed until the formulation was homogeneous and uniform. In step 5, the organic acid buffer, preservative, and sweeteners were added to the premix, and mixed until homogeneous and uniform. In step 6, the dye was added to the premix and mixed until the formulation was homogeneous and uniform. [0119] Formulations 1C, 1D, and 1E: In step 1, the polyol solvent (i.e., propylene glycol) was put in an appropriately sized tank (or vessel). The organic acid buffer was added to the polyol solvent to form a first premix and mixed until homogeneous and uniform. In step 2, instead of forming a second premix of active oil and a second polyol solvent and adding the second premix to a third premix comprising water, surfactant, preservative and sweetener, the active oils and flavor were added directly to the first premix and mixed until homogeneous and uniform. In step 3, the sugar alcohol co-solvent was added to the first premix and mixed until the formulation was homogeneous and uniform. In step 4, the surfactant was added to the first premix and mixed until the formulation was homogeneous and uniform. In step 5, the water, sweeteners, and preservative were added to the first premix, and mixed until homogeneous and uniform. In step 6, the dye was added to the first premix and mixed until the formulation was homogeneous and uniform. In Formulations 1D and 1E, higher levels of surfactant were added, when compared to Formulation 1C. [0120] Formulation 1F: In step 1, in a first appropriately sized tank (or vessel), a first premix was formed by adding 5% first polyol solvent (i.e., propylene glycol) to active oils and flavor and mixed until they were homogeneous and uniform. In step 2, in a second appropriately sized tank (or vessel), a second premix was formed by adding 2.0% second polyol solvent which was the same as the first polyol solvent to an organic acid buffer and mixed in the second tank until homogeneous and uniform. In step 3, instead of adding as the final component in the final step of the formulation process, the sugar alcohol solvent was added and mixed directly into the first premix until homogeneous and uniform before adding the surfactant, water, preservative, sweeteners and dyes. In step 4, the surfactant was added and mixed into the first premix until the formulation was homogeneous and uniform. In step 5, the water was added and mixed into the first premix until the formulation was homogeneous and uniform. In step 6, the second premix was added to the first premix and mixed until the formulation was homogeneous and uniform. In step 7, the preservative and sweeteners were added, and mixed until homogeneous and uniform. In step 8, the dye was added and mixed until the formulation was homogeneous and uniform. [0121] Formulation 1G (using the inventive process): In step 1, in a first appropriately sized tank (or vessel), a premix was formed by adding 5.0% first polyol solvent (i.e., propylene glycol), active oils and flavor and mixed until homogeneous and uniform. In step 2, in a second appropriately sized tank (or vessel), a second premix was formed by adding to an organic acid buffer 2.0% second polyol solvent which was the same as the first polyol solvent and mixed until homogeneous and uniform. In step 3, in a third appropriately sized tank (or vessel), a third premix was formed by adding surfactant, preservative and sweeteners to water and mixing until homogeneous and uniform. In step 4, the first premix was added to the third premix and mixed until homogeneous and uniform. In step 5, the second premix was added to the mixture of the first and third premixes and mixed until homogeneous and uniform. In step 6, the dye was added to the mixture of the three premixes and mixed until homogeneous and uniform. In step 7, the sugar alcohol was added as the final component to the mixture of the three premixes and mixed until the final mixture was homogeneous and uniform. [0122] Formulation 1H: In step 1, in a first appropriately sized tank (or vessel), instead of forming separate premixes (one premix containing the active oils and the other premix containing the organic acid buffer), a first premix was formed by adding both organic acid buffer and active oils to a polyol solvent (i.e., propylene glycol) and flavor and mixing until homogeneous and uniform. In step 2, in a second appropriately sized tank (or vessel), instead of adding as the final component in the final step of the formulation process, the sugar alcohol solvent was added to surfactant, preservative, sweeteners and water and mixed until homogeneous and uniform to form a second premix. In step 3, the first premix was added to the second premix and mixed until homogeneous and uniform. In step 4, the dye was added to the mixture of the two premixes and mixed until homogeneous and uniform. [0123] Formulation 1I: In step 1, in a first appropriately sized tank (or vessel), a first premix was formed by adding 5.0% first polyol solvent (i.e., propylene glycol) to active oils and flavor and mixed until homogeneous and uniform. In step 2, in a second appropriately sized tank (or vessel), a second premix was formed by adding 2.0% second polyol solvent which was the same as the first polyol solvent to an organic acid buffer and mixed until homogeneous and uniform. In step 3, a third appropriately sized tank (or vessel), a third premix was formed by adding surfactant, sorbitol, preservative and sweeteners water and mixing until homogeneous and uniform. In step 4, instead of adding the first premix to the third premix, the second premix was added to the third premix and mixed until homogeneous and uniform. In step 5, the first premix is added to the mixture of the second premix and third premix and mixed until homogeneous and uniform. In step 6, the dye was added and mixed until uniform. [0124] In addition to the listing the formulation ingredients, Table 1 shows the results of the turbidity test, in Nephelometric Turbidity Units (NTU), and S. mutans biofilm kill tests, in log RLU and M-Factor units. A typical M-factor for a commercially available alcohol containing essential oil mouth rinse is about 1.87 (log RLU of 5.8) in this model. [0125] Table 1 also shows that all formulations containing sodium lauryl sulfate (Formulations 1A, 1B, 1C and 1F through 1I) displayed high biocidal activity (M-factor between 1.66 and 2.22). However, the turbidity of all of three sodium lauryl sulfate formulations (1A, 1B, and 1C) was high (NTU greater than about 10.5). When the total surfactant concentration level was raised to 2.0% (Formulations 1D and 1E), the turbidity improved, however, at such a high surfactant concentration level, the biocidal activity, as measured by M-factor, decreased substantially (M-factor=0.03 and −0.01, respectively). Only the formulation formed by the inventive processes of the present invention (Formulation 1G) provided both good efficacy (M-factor=2.05) and the lowest turbidity (NTU less than 4.0).

1a

BACKGROUND OF THE INVENTION It is common practice in feeding infants of a certain range of ages to provide the infant with a container of milk at one end of which is provided a nipple. Although there are very many alternative versions of such feeding methods, a glass or plastic bottle is the common method. The bottle is provided with a cap to which is attached a flexible or elastomer nipple. In such cases, it is important that a means be provided to admit air to the bottle at the same time that the infant is sucking the milk from the nipple. This need for an air vent is not necessary in the case of a flexible bag, because it simply collapses as the milk is removed. The major problem encountered with most of these methods is that of sanitation. In the case of the glass or plastic bottle, it is necessary to sterilize not only the bottle, but also the cap and the nipple that are used with it. Some of the parts deteriorate rapidly when exposed to water of sufficient temperature to kill bacteria. In the case of the flexible milk bag, the many parts that have to be assembled to make up the bottle leads to the possibility of the bags, nipples and other elements becoming contaminated during storage, sale, or use. The ideal system would involve elements which remain in sterile condition until used and are then disposed of. In this way, the baby is not exposed to any disease-causing bacteria. Unfortunately, those disposable systems that have been developed in the past have suffered from a number of deficiencies. In many cases, they are not capable of being initially sanitized and then remain that way until the baby has used them. Furthermore, in most cases, the equipment has been very expensive and, therefore, it is not economically feasible to dispose of them after use. These and other difficulties experienced with the prior art devices have been obviated in a novel manner by the present invention. It is, therefore, an outstanding object of the invention to provide an infant feeding system in which the elements are maintained in a sterile condition from the time of manufacture to the time of use. Another object of this invention is the provision of an infant feeding system in which the parts can be manufactured and assembled cheaply, thus rendering it possible to dispose of the feeding elements immediately after use. A further object of the present invention is the provision of a feeding system in which the major elements of the apparatus are preassembled in a sterile condition and are not, therefore, contaminated by being assembled at the point of use. It is another object of the instant invention to provide an infant feeding system in which the elements are assembled in a convenient storage group and enclosed in a wrap that maintains them in sterile condition until use. A still further object of the invention is the provision of a system for feeding infants in which it is possible to assemble the parts for feeding without contamination from the hands of the assembler. It is a further object of the invention to provide a system for infant feeding devices in which a large number of disposable feeding devices are compactly packaged for storage and transportation. It is a still further object of the present invention to provide a system for the storage and sanitary packaging of a substantial number of feeding elements. Another object of the invention is the provision of infant feeding system which is simple in construction, which can be inexpensively manufactured, and which is capable of use in a situation where sanitary storage is difficult. With these and other objects in view, as will be apparent to those skilled in the art, the invention resides in the combination of parts set forth in the specification and covered by the claims appended hereto. SUMMARY OF THE INVENTION In general, the invention consists of an infant feeding system having a casing of elongated tubular form with upper and lower open ends, the casing having a reduced portion at the upper end and a bore entering the lower end. A first ring is carried on the reduced portion with a milk bag carried on one side inside the casing and with a nipple extending from the other side in normal position. A second ring is carried in the bore of the casing with a milk bag carried on one side and with a nipple carried in the ring in storage position and extending into the bag. More specifically, a plurality of disposable units are carried in the bore, each unit including a ring, milk bag, and nipple. The ring has a cylindrical outer surface that is slidably carried in the bore and the bag is compressed to occupy a small space. The ring has a tubular skirt with internal threads that mate with external threads on the reduced portion of the casing. The ring also has a tubular portion extending concentrically of and spaced inwardly of the skirt and a milk bag having an open end fits tightly around the said tubular portion. BRIEF DESCRIPTION OF THE DRAWINGS The character of the invention, however, may be best understood by reference to one of its structural forms, as illustrated by the accompanying drawings, in which: FIG. 1 is a front elevational view of an infant feeding system incorporating the principles of the present invention, FIG. 2 is an exploded view of the system showing some of the elements in front elevation, FIG. 3 is a vertical sectional view of a nipple unit forming part of the invention, taken on the line III--III of FIG. 2, FIG. 4 is an enlarged view of a portion of the nipple unit showing the construction in detail, FIG. 5 is a vertical sectional view of a casing forming part of the invention, taken on the line V--V of FIG. 2, FIG. 6 is a vertical sectional view of the invention taken on the line VI--VI of FIG. 2, FIG. 7 is a front elevational view with portions broken away of the infant feeding system during shipping and storage, FIG. 8 is a front elevational view of a storage unit forming part of the invention, FIG. 9 is a vertical sectional view of the storage unit taken on the line IX--IX of FIG. 8, FIG. 10 is a vertical sectional view of a protector forming part of the invention taken on the line X--X of FIG. 2, FIG. 11 is an exploded view of the elements making up the storage unit shown in FIG. 9, FIG. 12 is a vertical sectional view of the assembly during feeding, taken on the line XII--XII of FIG. 1; and FIG. 13 is an enlarged sectional view of a portion of the apparatus taken on the line XIII--XIII of FIG. 12. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring first to FIG. 1, wherein are best shown the general features of the invention, the infant feeding system, indicated generally by the reference numeral 10, is shown as consisting of a nipple 11 which is mounted on a ring 12 which in turn is mounted on one end of a casing 13. This is the condition of the infant feeding system when it is ready for use by the baby with milk carried in the interior. FIG. 2 is an exploded view which shows the elements in the manner in which they are assembled for use. Also shown are additional elements that can not be seen in FIG. 1. Obvious in this view is a milk bag 14 which extends downwardly from the ring 12 and which normally lies inside the casing 13. FIG. 2 also shows a cap 15 which can be used with the system to protect the nipple 11 from contamination before use. Referring to FIG. 3 and 4, it can be seen that the nipple 11 is formed in the usual way of elastomer, such as latex, and is associated with a base 16 and a lockwasher 17. FIG. 5 shows the construction of the casing 13, particularly the manner in which it is formed as an elongated tube, having an open upper end 18 and an open lower end 19. The casing has an externally threaded reduced portion 21 at its upper end. The reduced portion has a bore 22 which is substantially smaller in diameter than a bore 23 which enters the lower end 19 and extends throughout most of the height of the casing. Referring to FIG. 6, which shows the details of the ring 12, it can be seen that the ring is of generally disk-like configuration and is provided with an outer circular cylindrical surface 24. The surface is formed on a skirt 25, which skirt is provided with internal threads 26 adapted to mate with the external threads on the reduced portion 21 of the casing 13. The ring also has a tubular portion 27 which extends concentrically of and is spaced inwardly of the skirt 25 and the cylindrical surface 24. The milk bag 14 has an open upper end that fits snugly and is fastened securely to the outer cylindrical surface of the tubular portion 27 of the ring. When unfolded, this bag 14 (as is evident in FIG. 2) extends substantially the entire length of the casing 13, resides in the bore 23, and has its lower end located close to the lower end 19 of the casing. FIG. 7 shows the assembly of the system during shipment and storage before use by the consumer. In this assembly, the casing 13 carries the ring 12 which is attached to the cap 15. In the bore 23 of the casing are located a plurality of storage units 28. The entire assembly of cap 15, ring 12, casing 13, and storage units 28 are completely encapsulated in a clear shrink wrap, not shown. FIG. 8 shows the exterior of one of the storage units 28; it can be seen that the ring 12 has connected to it a transparent plastic cover 29. The assemblage of the cover and the ring are normally completely wrapped in a thin transparent shrink wrap to render it entirely impervious to bacterial entry. Through the transparent cover can be seen some of the contents, including the nipple 11 and the milk bag 14. FIG. 9 shows a sectional view through the storage unit 28 and the details of that assemblage. First of all, it can be seen that the nipple 11 with its associated base 16 and lockwasher 17 are inserted as a unit inside of the ring 12. Overlying the nipple and locked between the ring 12 and the base 16 is a protector 31. The bag 14 (in folded condition) overlies the nipple and the protector 31. Of course, the cover 29 extends from the bottom of the skirt 25 of the ring. It can be seen that the bag 14 is neatly folded in the annular space that surrounds the nipple 11 and its protector 31, the outer periphery of which is determined by the transparent cover 29. Finally, a disk 32 entirely covers the lower end of the ring 12, while the entire assemblage is provided with a shrink wrap (not shown) that renders the entire unit free of bacteria. FIG. 10 shows the details of the cap 15 which is formed of thin plastic and is provided with an outwardly extending flange 33 the outer of which is provided with an axial ring 34 which is of a size to fit snugly in a bore 48 in the end of the ring 12 when the nipple 11 is in place. FIG. 11 is helpful in understanding the assemblage of the storage unit 28, because it shows in general the order in which the parts are put together. First, the nipple 11 is assembled with its base 16 locked in place by the lockwasher 17. These three elements are combined with the protector 31 and inserted into the ring 12 which has already been provided with the milk bag 14. The disk 32 is then applied to the ring 12, the cover 29 is assembled in place, and the entire assemblage enclosed in a shrink wrap. FIG. 12 is a sectional view showing the condition of the infant feeding system 10 with the milk 35 in place in the milk bag 14. The ring 12 is mounted at the top of the casing 13. The nipple 11 (mounted on its base 16 and its lockwasher 17) is securely snapped in place in the ring 12, this engagement being tight enough to prevent leakage of the milk 35. It should be noted that the casing 13 is provided with windows 36 by which it is possible to observe the level of milk 35 in the bag 14. FIG. 13 shows the manner in which the nipple 11 with its base 16 and its lockwasher 17 are held in the ring 12 during use by the infant. The details of the interconnection between the nipple 11, its base 16, and its lockwasher 17 are shown in FIGS. 3 and 4. The nipple 11 is formed of an elastomer and is provided with an open lower end which terminates in a solid annulus 36. The base 16 is generally circular and has a central bore 37 which is formed with a radial groove 38 that receives the annulus 36. The lockwasher 17 has a central tubular portion 39 that lies in the bore 37 of the base 16 and locks the annulus 36 in the groove 38. The base and washer have a one-way fastening means for locking them in fixed position; this fastening means consists of an axial recess 41 formed in the base 16 and an axial tubular protuberance 42 formed on the lockwasher 17. The recess and the protuberance have matching conical surfaces 43 and 44, respectively, that terminate in radial shelf surfaces that engage in locking position. The recess and the protuberance are each provided with secondary conical surfaces 45 and 46, respectively, that are opposed to the shelf surfaces when the base and washer are in the locking position. The manner in which the base 16 (which carries the nipple 11 and the lockwasher 17) is snapped in place in the ring 12 can best be seen in FIG. 13. The base 16 has an outer conical surface 47 (see also FIG. 3), while the ring has a bore 48 with a conical surface 49 (see also FIG. 6) that matches and faces the conical surface 47 on the base. These conical surfaces 47 and 49 terminate in radial shelves that are in engagement when the base and ring are in locking position. These radial shelves are shelf 51 on the base 16 (shown in FIG. 4) and the shelf 52 on the ring 12 (shown in FIG. 6). One of the interesting aspects of the present construction is that the outer surface 24 of the ring 12 has such a diameter that it may fit snugly in the bore 23 of the casing 13. At the same time, the outer diameter of the tubular portion 27 (even with the milk bag 14 in place) can fit into the smaller upper bore 22 of the casing. This is true even under certain circumstances when it is not desirable to engage the threads 26 of the skirt 25 with the threaded reduced portion 21 of the casing. In that case, because the tubular portion 27 extends a considerable distance below the bottom of the skirt 25, the ring can sit on top of the reduced portion without being threaded to it, but will still be stable, because of the presence of the tubular portion 27 extending a substantial distance into the bore 22. In other words, the ring, along with the associated nipple and other equipment that go with it, can fit snugly into the bore 23 for storage. It will fit at the top of the casing either for storage at the point of sale or for use as shown in FIG. 1. This situation prevails even when the unit 28 is completely covered with a shrink wrap 40. The shrink wrap is thin enough and the tolerance such that the surface 24 of the ring 12 can fit in the bore 23 and the surface of the tubular portion 27 can fit in the bore 22. The operation and advantages of the present invention will now be readily understood in view of the above description. To begin with, all of the elements of the infant feeding system 10 will be completely sterilized at the manufacturing plant and assembled into a package that has the appearance of FIG. 7, except that a complete shrink wrap of this transparent polymer will be provided around the entire assemblage. Lying within the ring 12 and the cap 15 at the top of the package will be an assembly similar to that shown in FIG. 9 but with the nipple 11 and its base 16 and its locking washer 17 placed in reverse position (like the condition shown in FIG. 13), but with the protector 31 and everything else in the same general condition. The nipple is protected by the cap 15 which fits snugly into the bore 48 at the top of the ring. The other units 28 will be stored in the remainder of the bore 23 of the casing that is not occupied by the top element. In order to place the equipment in condition for use by the baby, the parent, first of all, removes the storage units 28 from the bore 23. He then removes the shrink wrap and disk 32, allowing the protector 31 with the nipple retained in it to drop into his hand. He then reverses the ring 12 and introduces the base 16 into the top of the ring 12. He does this while holding the protector 31, so that his fingers do not touch either the nipple or its associated equipment. The base is snapped into the ring 12 and protector is then removed and thrown away. Holding onto the ring 12, the parent then removes the cover 28, which allows the bag to drop down. He introduces the milk 35 into the bag and then snaps the base 16 into place in the top of the ring. The ring then can be screwed on the threaded upper reduced portion of the casing. The apparatus is then in the condition shown in FIG. 12 ready for use by the baby. It should be noted that, at the point of sale and when the assemblage is brought home, the first element lying under the cap 15 is a nipple 11 with its associated protector 31 already in place on the ring. It is necessary, however, to remove the ring and the nipple before use since the cover 28 is still in place. Once that cover and the shrink wrap are removed, the elements are ready for use in the same way. The nipple, of course, with its protector 31 has to be removed in order to insert milk into the milk bag 14. Before the first unit (mounted at the top of the casing) is used, the storage units 38 must be removed from the casing and carried in a convenient bag or the like. Since each storage unit is individually shrink wrapped, there is no danger of contamination. Normally, the assembly of the units shown in FIGS. 3 and 4, i.e., the nipple 11, the base 16, and the lockwasher 17, takes place in the factory under ideal sanitary conditions. Furthermore, this unit is incorporated in the ring 12 with the bag 14 and the cover 28 in the manner shown in FIG. 9. After the cap 15 has been snapped in place (in the bore 48 of the ring 12), the entire assemblage, including the casing 13, the ring 12, and the cap 15, is shrink wrapped once more and this shrink wrap is not removed until the parent takes the assemblage home. After the baby is through drinking the milk 35 from the milk bag 14 (of the unit, as shown in FIG. 12), the ring 12 is unscrewed from the top of the casing 13 and the assemblage is thrown away. The nipple 11 and its associated equipment is, therefore, disposed of along with the empty bag 14. These units are never used again. When the infant is to be fed once more, the same casing, of course, is used with the remainder of the units 28 to provide separate feedings. It can be seen, then, that by use of the present system, it is possible to provide inexpensive disposable feeding equipment that is maintained in an entirely sanitary condition, since human hands do not touch the critical portions of the equipment. The parent may handle the outside of the ring 12 and the outside of the casing 13, but his manipulation of the nipple 11 and its associated base 16 and lockwasher 17 takes place by pinching the protector 31; the protector is then thrown away once the nipple is in place on the ring. The release of the bag 14 takes place by removing the cover 28 and it is not ever necessary to touch the inside of the bag. The milk is introduced into the bag through the bore 48 in the ring, but the interior of the bag and the interior of the ring are never touched by human hands after sterilization in the manufacturing plant. The materials from which the equipment is made lend themself to being formed by the inexpensive injection molding methods and these are materials that can be relatively inexpensive. The use of the nipple 11 with an annulus 36 that locks in the base 16 means that a minimum amount of latex or silicone is used in the nipple. Since these materials are the most expensive of the materials, maintaining their use at a minimum in this way is a desirable feature in making the equipment disposable. Furthermore, since shipment from the manufacturing plant to the point of sale is an expensive part of the pricing of any article, the fact that a great many of the feeding units 28 are storable in the casing when it is shipped is a feature that is desirable. In other words, very little vacant space is being shipped, compared with the conventional milk bottle, which is shipped in an empty condition and occupies a great deal of space for its weight. It is obvious that minor changes may be made in the form and construction of the invention without departing from the material spirit thereof. It is not, however, desired to confine the invention to the exact form herein shown and described, but it is desired to include all such as properly come within the scope claimed.

1a

BACKGROUND [0001] Social Media Games may be played between users over an online social network with a mobile phone or smart mobile device. These games may be played by multiple users competitively against one another or these games may be played individually, at large, against the online community or portions of it. Additionally, these games may be played collaboratively. These games may consist of puzzles that users may solve to unlock additional messages, levels, prizes, or for the thrill of the game. SUMMARY [0002] According to an exemplary embodiment, an interactive social media game may be played on an electronic social media network with any number of unique users, players, or devices. A first device may create a disassembled photographic media puzzle through manipulation on a display screen, in a first memory location and transmit a request to share a disassembled photographic media puzzle by a transceiver. A second device may receive the disassembled photographic media puzzle by a transceiver and store it in a second memory location. The second device may re-assemble the disassembled photographic media puzzle through manipulation on a display screen into a re-assembled photographic media puzzle. The re-assembled photographic media puzzle may be automatically verified for correctness against a solution on a puzzle piece by puzzle piece basis. [0003] According to another exemplary embodiment, an interactive social media game may consist of at least one device and a computer database. The computer database may transmit a disassembled photographic media puzzle by a transceiver. The at least one device may receive the disassembled photographic media puzzle by a transceiver. The at least one device may store the disassembled photographic media puzzle in a memory location. The at least one device may re-assemble, through manipulation on a display screen, the disassembled photographic media puzzle into a re-assembled photographic media puzzle. The re-assembled photographic media puzzle may be automatically verified for correctness against a solution on a puzzle piece by puzzle piece basis. [0004] According to another exemplary embodiment, a computing system may execute a set of instructions for an interactive social media game. The computing system may take an electronic photograph by an electronic photography device and lens and store the electronic photograph in a first memory location. A device may manipulate a disassembled photographic media puzzle on a display interface. The device may create a disassembled photographic media puzzle through manipulation on a first display interface and store it in a first memory location. The device may transmit the disassembled photographic media puzzle by a transceiver. A second device may receive the disassembled photographic media puzzle by a transceiver and store the disassembled photographic media puzzle in a second memory location. The second device may re-assemble the disassembled photographic media puzzle into a re-assembled photographic media puzzle through manipulation on a second display interface. The re-assembled photographic media puzzle may be automatically verified for correctness against a solution on a puzzle piece by puzzle piece basis. BRIEF DESCRIPTION OF THE FIGURES [0005] Advantages of embodiments of the present invention will be apparent from the following detailed description of the exemplary embodiments. The following detailed description should be considered in conjunction with the accompanying figures in which: [0006] Exemplary FIG. 1 may show an exemplary flow chart of an electronic social media network or game; [0007] Exemplary FIG. 2 may show an exemplary flow chart of an electronic social media network or game; [0008] Exemplary FIG. 3 may show a flow chart of the steps a non-transitory computer readable medium of an electronic social media network or game may implement; [0009] Exemplary FIG. 4 may show a depiction of a disassembled photographic media puzzle; [0010] Exemplary FIG. 5 may show an alternate depiction of a disassembled photographic media puzzle; [0011] Exemplary FIG. 6 may show an alternate depiction of a disassembled photographic media puzzle; [0012] Exemplary FIG. 7 may show the steps of a message system of an electronic social media network or game; and [0013] Exemplary FIG. 8 may show the steps of a time recordation system of an electronic social media network or game. DETAILED DESCRIPTION [0014] Aspects of the invention are disclosed in the following description and related drawings directed to specific embodiments of the invention. Alternate embodiments may be devised without departing from the spirit or the scope of the invention. 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. Further, to facilitate an understanding of the description discussion of several terms used herein follows. [0015] As used herein, the word “exemplary” means “serving as an example, instance or illustration.” The embodiments described herein are not limiting, but rather are exemplary only. It should be understood that the described embodiments are not necessarily to be construed as preferred or advantageous over other embodiments. Moreover, the terms “embodiments of the invention”, “embodiments” or “invention” do not require that all embodiments of the invention include the discussed feature, advantage or mode of operation. [0016] Further, many of the embodiments described herein may be described in terms of sequences of actions to be performed by, for example, elements of a computing device. It should be recognized by those skilled in the art that the various sequence of actions described herein can be performed by specific circuits (e.g., application specific integrated circuits (ASICs)) and/or by program instructions executed by at least one processor. Additionally, the sequence of actions described herein can be embodied entirely within any form of computer-readable storage medium such that execution of the sequence of actions enables the processor to perform the functionality described herein. Thus, the various aspects of the present invention may be embodied in a number of different forms, all of which have been contemplated to be within the scope of the claimed subject matter. In addition, for each of the embodiments described herein, the corresponding form of any such embodiments may be described herein as, for example, “a computer configured to” perform the described action. [0017] Referring to FIG. 1 generally, a photographic media puzzle game played on an electronic social media network may be disclosed. The electronic social media network or game may consist of multiple devices using non-transitory computer readable mediums, such as a smart phone, tablet, or other similarly situated device to play a photographic media puzzle game. The photographic media puzzle game may consist of a first device 102 , a second device, 104 and an electronic social media network 100 . The first device 102 may operate a first non-transitory computer readable medium. The second device 104 may operate a second non transitory computer readable medium. A first device 102 may select 106 an image. The image may be a photograph taken by an electronic smart phone, tablet, or other similarly situated device that can take a photograph. The image may also be a stock image that the device may have downloaded to an electronic smart phone, tablet, or other similarly situated device. Next, the first device 102 may edit 108 the image. The step of editing 108 the image may be any type of image editing options common to electronic smart phones, tablets, and other similarly situated devices known in the art such as applying a filter. Next, the device may create 110 a disassembled photographic media puzzle. The device may create 110 the disassembled photographic media puzzle through manipulation on a display interface such as a touch screen. For example, the device may partition the image into unique puzzle pieces by finger swiping across a display interface. Alternatively, the device may partition the image into unique puzzle pieces automatically. Alternatively, the device may allow a user to manually manipulate the location, size, and type of puzzle piece. The disassembled photographic media puzzle may be stored in a first memory location. The disassembled photographic media puzzle may be an edited 108 image or it may be the original selected 106 image. The disassembled photographic media puzzle may be a matrix of any number of uniform pieces. The disassembled photographic media puzzle may be a plurality of any number of non-uniform pieces. The device may transmit 112 the disassembled photographic media puzzle by a transceiver to a second device. The transceiver may be a local area network, cell phone signal, wireless signal, or any other hardware element capable of transmitting data elements from a first memory location to a second memory location. The disassembled photographic media puzzle may be transmitted 112 across the electronic social media network to a second device 104 . The second device 104 may be a native contact of the first device 102 that may store the second devices 104 information in the contacts menu of an electronic smart phone, tablet, or any other similarly situated device known in the art. The second device 104 may receive 114 the disassembled photographic media puzzle that a first device 102 transmit 112 . Next, the second device 104 may store 116 the disassembled photographic media puzzle in a second memory location. Next, the second device may re-assemble 118 the disassembled photographic media puzzle into a re-assembled photographic media puzzle. The re-assembled photographic media puzzle may be verified 120 automatically on a puzzle piece by puzzle piece basis for correctness against a solution. The re-assembled photographic media puzzle may be verified 120 by displaying the re-assembled photographic media puzzle on the first device thereby allowing the first device to verify 120 the re-assembled photographic media puzzle manually. The disassembled photographic media puzzle may be automatically verified 120 for correctness against a solution on a puzzle piece by puzzle piece basis. The electronic social media network may verify the puzzle against a database of solutions. The solution may be established by the first device 102 . The solution may originate on the electronic social media network or the solution may be established by the first device 102 . [0018] Referring to FIG. 2 generally, a photographic media puzzle game on an electronic social media network may be disclosed. An at least one device 204 may be in communication with an electronic social media network 200 . The electronic social media network 200 may be in communication with an at least one non-transitory computer database 202 . The at least one non-transitory computer database 202 may physically store data elements of the electronic social media network. The at least one non-transitory computer database 202 may transmit 207 a disassembled photographic media puzzle by a transceiver. Any number of optional additional devices 206 and optional computer databases 205 may be in communication with an electronic social media network 200 . The at least one device 204 may be in communication with an electronic social media network 200 such that the at least one device 204 may receive 208 a puzzle by a transceiver. The at least one device 204 may chose a disassembled photographic media puzzle based on a category, sub-category, or group of interest. Additionally, the at least one device 204 may choose the difficulty of the puzzle. The difficulty may correspond to the number of unique pieces that make up the disassembled photographic media puzzle. The puzzle may have been previously disassembled by the electronic social media network or an optional additional device 206 or an optional database 205 . Alternatively the disassembled photographic media puzzle may have originated from any unique location such that it may be reducible to a stored location on the electronic social media network. The at least one device 204 may re-assemble 212 the puzzle. The at least one device 204 may move pieces of the puzzle into a location by manually dragging the pieces of the puzzle into the desired virtual location on a display interface such as a touch screen. The at least one device 204 may move pieces of the puzzle through any desired form of manipulation commonly known in the art of computer, tablet, and electronic smart phone interaction. The re-assembled photographic media puzzle may be verified 214 automatically on a puzzle piece by puzzle piece basis for correctness against a solution. The disassembled photographic media puzzle may be automatically verified 214 for correctness against a solution on a puzzle piece by puzzle piece basis. The electronic social media network may verify the puzzle against a database of solutions that may be stored on the computer database. [0019] Referring to FIG. 3 , a set of instructions to play a photographic media puzzle game may be disclosed. The set of instructions may be stored and carried out by a first non-transitory computer readable medium and a second non transitory computer readable medium or any number of additional non transitory computer readable mediums. The non-transitory computer readable mediums may be a smart mobile device, smart phone, tablet, or other similarly situated device known in the art. Additionally, the set of instructions may begin or resume at any unique step. The set of instructions may be limited to a single actor or multiple actors. The set of instructions may begin with starting 300 . A first device may take a photograph 302 with a camera lens. The first device may store 304 a photograph in a first memory location. The first device may manipulate 306 the electronic photograph on a first display interface. The first device may apply any filter or perform any photo manipulation or editing that may commonly be known within the art of electronic photography. Next, the first device may create 308 a disassembled photographic media puzzle on a first device. The disassembled photographic media puzzle may be created from a photograph, image, or other manipulated image or photograph. The disassembled photographic media puzzle may be a matrix of any number of uniform pieces. The disassembled photographic media puzzle may be a plurality of any number of non-uniform pieces. Next, the first device may transmit 310 the disassembled photographic media puzzle to a second non-transitory computer readable medium by a transceiver. The second device may receive 312 the disassembled photographic media puzzle. The second device may store 314 the disassembled photographic media puzzle. The second device may re-assemble 316 the disassembled photographic media puzzle. Finally, the disassembled photographic media puzzle may be automatically verified 318 for correctness against a solution on a puzzle piece by puzzle piece basis, where each of the puzzle pieces of the re-assembled photographic media puzzle is compared to the corresponding position of a solution for correctness. The electronic social media network may verify the puzzle against a database of solutions. [0020] Referring generally to FIG. 4 , an exemplary embodiment of a disassembled photographic media puzzle may be disclosed. A device 401 may be an electronic smart phone, tablet, or any other similarly situated device known in the art. The device 401 may have a display screen 402 , an electronic camera 444 , and an electronic flash system 446 . The device may take a photograph with the electronic camera 444 . The electronic flash system 446 may or may not be used. The photograph may be used as the basis for creating a disassembled photographic media puzzle. Optionally, the image used to create the disassembled photographic media puzzle may be downloaded from a database or a stock photo stored on the device. A solution may be created by storing the initial presentation of the puzzle pieces. The solution may later be used as the basis for comparison and verification of the re-assembled photographic media puzzle. Groups of rectangular cells 403 through 408 may be displayed by the display screen 402 . The groups of rectangular cells 403 through 408 may represent a disassembled photographic media puzzle. The disassembled photographic media puzzle may consist of a first row of three cells 403 , a second row of three cells 405 , and a third row of three cells 407 . The disassembled photographic media puzzle may consist of a first column of three cells 404 , a second column of three cells 406 , and a third column of three cells 408 . The three rows of three cells 403 , 405 and 407 respectively in combination with the three columns of three cells 404 , 406 , and 408 respectively may be arranged such that a total of nine cells may represent a disassembled photographic media puzzle. [0021] Referring generally to FIG. 5 , an exemplary embodiment of a disassembled photographic media puzzle may be disclosed. A device 501 may be an electronic smart phone, tablet, or any other similarly situated device known in the art. The device 501 may have a display screen 502 , an electronic camera 555 , and an electronic flash system 556 . The device 501 may take a photograph with the electronic camera 555 . Additionally the electronic flash system 556 may or may not be used. The photograph may be used as the basis for creating a disassembled photographic media puzzle. Optionally, the image used to create the disassembled photographic media puzzle may be downloaded from a database or a stock photo stored on the device. A solution may be created by storing the initial presentation of the puzzle pieces. The solution may later be used as the basis for comparison and verification of the re-assembled photographic media puzzle. Groups of rectangular cells 503 through 510 may be displayed by the display screen 502 . The groups of rectangular cells 503 through 510 may represent a disassembled photographic media puzzle. The disassembled photographic media puzzle may consist of a first row of four cells 503 , a second row of four cells 505 , a third row of four cells 507 , and a fourth row of four cells 509 . The disassembled photographic media puzzle may consist of a first column of four cells 504 , a second column of four cells 506 , a third column of four cells 508 , and a fourth column of four cells 510 . The four rows of four cells 503 , 505 , 507 , and 509 respectively and in combination with the four columns of four cells 504 , 506 , 508 , and 510 respectively may be arranged such that a total of sixteen cells may represent a disassembled photographic media puzzle. [0022] Referring generally to FIG. 6 , an exemplary embodiment of a disassembled photographic media puzzle may be disclosed. A device 601 may be an electronic smart phone, tablet, or any other similarly situated device known in the art. The device 601 may have a display screen 602 , an electronic camera 666 , and an electronic flash system 667 . The device 601 may take a photograph with the electronic camera 666 . Additionally, the electronic flash system 667 may or may not be used. The photograph may be used as the basis for creating a disassembled photographic media puzzle. Optionally, the image used to create the disassembled photographic media puzzle may be downloaded from a database or a stock photo stored on the device. A solution may be created by storing the initial presentation of the puzzle pieces. The solution may later be used as the basis for comparison and verification of the re-assembled photographic media puzzle. Groups of rectangular cells 603 through 612 may be displayed by the display screen 602 . The groups of rectangular cells 603 through 612 may represent a disassembled photographic media puzzle. The disassembled photographic media puzzle may consist of a first row of five cells 603 , a second row of five cells 605 , a third row of five cells 607 , a fourth row of five cells 609 and a fifth row of five cells 611 . The disassembled photographic media puzzle may consist of a first column of five cells 604 , a second column of five cells 606 , a third column of five cells 608 , a fourth column of five cells 610 , and a fifth column of five cells 612 . The five rows of five cells 603 , 605 , 607 , 609 and 611 respectively and in combination with the five columns of five cells 604 , 606 , 608 , 610 , and 612 respectively may be arranged such that a total of twenty five cells may represent a disassembled photographic media puzzle. [0023] Referring generally to FIG. 7 , an exemplary embodiment of a photographic media puzzle and a corresponding messaging method of an electronic social media network may be disclosed. A first device 700 may input a first message 704 and transmit the message 710 to a second device 702 by a transceiver. The second device 702 may store 714 the first message 704 . The second device 702 may display the message 712 . The second device 702 may display the message on the display screen of any device such as an electronic smart phone, tablet, or any other similarly situated device known in the art. The first message 704 may display prior to the second devices 702 attempt to re-assemble the puzzle 716 . Alternatively, the first message may be intended as an invitation to join the electronic social media network. A first device 700 may input a second message 706 and a third message 708 . The first device 700 may transmit 710 the messages to a second device 702 . The second device 702 may be a native contact of the first device 700 who may store the second devices 702 information in the contacts menu of an electronic smart phone, tablet, or any other similarly situated device known in the art. The second device 702 may store 714 the second message 706 and the third message 708 . The second device 702 may re-assemble the puzzle 716 . The disassembled photographic media puzzle may be automatically verified 718 for correctness against a solution on a puzzle piece by puzzle piece basis, each of the puzzle pieces of the re-assembled photographic media puzzle may be compared to the corresponding position of a solution for correctness. The electronic social media network may verify the puzzle against a database of solutions. Correct conditional operator 720 may be a yes/no conditional operation. The yes/no correct conditional operator 720 may be an additional step that may be dependent upon the verify puzzle 718 step. If the puzzle is verified as correct against a pre-determined solution a second message 724 may be displayed. If the message is not verified as correct a third message 726 may be displayed. The first 704 , second 706 , and third 708 messages may be multimedia messages that may contain data elements that may be used to play sound and movies. The first 704 , second 706 , and third 708 messages may be multimedia messages that may contain the solution to a disassembled photographic media puzzle. The first 704 , second 706 , and third 708 messages may be hyperlinks to e-commerce websites that may reward a user for playing the social media game. The first 704 , second 706 , and third 708 messages may be hyperlinks to send an SMS message to an original device or a new device. The first 704 , second 706 , and third 708 messages may be hyperlinks to any type of external computer implemented program, website, blog, or digital platform. [0024] Referring generally to FIG. 8 , an exemplary embodiment of a photographic media puzzle and a corresponding time recordation system may be disclosed. A device 800 may re-assemble 802 a disassembled photographic media puzzle, which may initiate a first time recordation 804 . After re-assembling the disassembled photographic media puzzle a verify 808 step may be performed. The disassembled photographic media puzzle may be automatically verified 808 for correctness against a solution on a puzzle piece by puzzle piece basis, each of the puzzle pieces of the re-assembled photographic media puzzle may be compared to the corresponding position of a solution for correctness. The electronic social media network may verify the puzzle against a database of solutions. Correct conditional operator 810 may be a yes/no conditional operation. The correct conditional operator 810 may be an additional step that may be dependent upon the verify puzzle 808 step. If the puzzle is verified as correct against a pre-determined solution a second time recordation 805 may occur. Additionally, if the puzzle is verified as correct against a pre-determined solution a calculate total time 811 step may be performed. The calculate total time 811 step may calculate the total time by determining the difference between the first time recordation 804 and the second time recordation 805 . The time may be recorded in any time display format commonly known in the art. Additionally, the time may be recorded 812 and displayed 814 on a social media network database 801 . The method of display may be a leaderboard or other method to display player statistics. The leaderboard may be organized by puzzle, category, or sub category. If the correct conditional operator 810 is not correct than the system may not calculate the total time 811 and may not record the total time 812 . Optionally, throughout the duration of playing the photographic media puzzle a timer conditional operator 820 may keep track of the total time a device has been re-assembling the disassembled photographic media puzzle. Timer conditional operator 820 may be a yes/no conditional operator. The timer conditional operator 820 may be an additional step that may be dependent upon a pre-determined device input. The timer conditional operator 820 may be configured for any range of time. The timer conditional operator 820 may be configured by a first device or by the social media network database. If the timer conditional operator 820 is not exceeded than the timer will do nothing. If the timer conditional operator 820 is exceeded than the game may end. [0025] The foregoing description and accompanying figures 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. [0026] Therefore, 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

This application is a divisional of application Ser. No. 07/762,868, filed Sep. 18, 1991, now U.S. Pat. No. 5,188,854. BACKGROUND OF THE INVENTION This invention relates to food technology and, more particularly, to seafood products. Imitation seafood products, or seafood analogs, are a fast growing segment of the food product industry. Such products result from processes wherein less expensive or underutilized fish or seafood varieties are converted into products with the form and taste of more desirable seafood varieties. The most prevalent examples of seafood analogs are those derived from surimi. Surimi is a form of minced fish flesh which has been processed to remove water soluble proteins. The minced flesh that remains is surimi. It is comprised of water insoluble proteins, largely in the form of short muscle fibers. When the surimi is ground or minced into a finely comminuted paste in the presence of salt, the surimi turns into a sticky paste having gel-forming characteristics, as the salt aids in extracting otherwise insoluble proteins from the muscle fibers. When subsequently heated, the proteins thus extracted into the paste will denature and form a gel. The final shape of the product is thus dictated by whatever mold or form it occupies at the point when the surimi paste is solidified. Surimi-based pastes are often used in forming seafood analogs, because of this gel-forming capacity, which also means that it can be molded or formed into virtually any desired shape. The gelling property also allows the texture to be varied somewhat, through controlling parameters involving gel strength and viscosity. Thus, the naturally occurring forms and textures of many types of seafood products can be duplicated, particularly those of shell fish. Other additives in addition to salt can be incorporated into the paste, and these often include flavorings derived from or reminiscent of the seafood variety to be duplicated. In this manner, underutilized marine fish are processed for the taste or flavor of, and then molded into the form of, more desirable seafood varieties, with the most frequently duplicated products being relatively expensive or rare shellfish varieties such as crab, shrimp or lobster. Recent advances have involved improvements in such aspects as the formulation of the surimi paste, or in ways to affect the gel forming step to impart specific properties to the final product. More specifically, many recent advances address the problem of providing a more natural texture to the surimi-based product, such as those disclosed in U.S. Pat. Nos. 4,301,812, 4,579,741, 4,584,204 and 4,919,959. These patents all provide processes for imparting a texture to the solidified surimi paste itself that will more closely duplicate the texture of the marine product being imitated. Other approaches for incorporating more of a natural texture to surimi-like products are disclosed in U.S. Pat. Nos. 3,863,017, 4,362,752, 4,588,601 and 4,888,181. In these patents, processes are disclosed wherein the surimi paste is blended with other materials which provide the texture. In each case the added texturizing material is a fibrous material, and these are added to provide the product with a texture reminiscent of natural muscle fiber. The disclosed processes result in final products approximating the textures of such seafood varieties as shrimp, prawn, crab and lobster. The texture is due to the particular kinds and amounts of fibers incorporated into the surimi paste matrix prior to solidifying, or gelling, the matrix. Because these surimi pastes form gels upon heating, it is easy to mold the imitation product into a desired shape. Because it is a gel, the final product will naturally have a rubbery or chewy feel. This limits the usefulness of such processes for duplicating fish products and when not producing shellfish analogs. In U.S. Pat. No. 4,301,182, an elaborate process is disclosed which duplicates a fish product such as flaked tuna. Dark meat portions of whole fish are minced into a fish paste and then extruded into a hot water bath. Extrusion is through a restricted orifice approximately 1 inch wide and 1/8 to 1/16 inch thick. The product is then further processed and preferably recombined with tuna loin meat prior to packaging Although the form and texture of shell fish can be duplicated with surimi pastes, the flakiness or forkability of fish steaks or fillets cannot be achieved with existing surimi processes. Cooked fish flesh has a desirable flaky character, such that the layers of muscle are easily pulled apart. Forkability is a term which describes the manner in which pieces of the flesh of cooked fish will easily pull apart with moderate pressure applied by a fork. It has heretofore been impossible to duplicate these characteristics in imitation seafood products so that close analogs of such seafood products as fish fillets or fish steaks could be produced. Among the objects of this invention, then, is to provide a process for producing formed fish products in a variety of heretofore unavailable forms and shapes. A more specific object is to provide fish products which duplicate the form and feel of true fish fillets and steaks. Another object is to provide a method for using surimi-based paste to produce analog fish products which have the form and feel of true fish fillets and steaks. A further object is to provide a product of integrated fish flesh which holds its shape without the addition of breading or other external binders. A still further object is to provide a method for producing imitation fish products where the texture of the final product is improved by utilizing as a starting material pieces of whole fish which have been cut or chunked and where the final fish product is fish flesh based. Another object is to provide a fully cooked formed fish product which is available to the consumer refrigerated and in a sterile package, and which can be quickly and easily warmed for eating. SUMMARY OF THE INVENTION For the achievement of these and other objects, this invention provides a process for preparing seafood analogs which can be used to produce formed fish products in styles or varieties which were previously unavailable. The preferred process comprises mixing whole fish flesh pieces or chunks with a coating of a paste of a surimi-based binder, with the former being held together by the latter in the final product. The products can be further processed for flavor and appearance. Since a relatively large proportion of the analog is comprised of intact or true pieces of fish flesh, the final product duplicates the texture of fish fillets or steaks, without having any of the rubbery or chewy characteristics of other surimi-based seafood analogs. The binder used can be a surimi paste, or any gelling substance which when solidified will set the whole, relatively intact chunks of fish flesh into the formed fish product. A surimi paste binder is preferably used in a minimal amount to coat pieces of fish flesh. The resulting mixture is formed into a shape, which is preferably analogous to that of a consumer-favored fish steak or fillet. The amount of surimi utilized is preferably only that amount which will completely coat the pieces and thus securely bind them together after the surimi has been gelled. The fish pieces preferably remain frozen throughout the mixing and forming steps of the process. This maintains the integrity of the fish muscle tissue, as the hard frozen tissue resists shearing or deformation from the stresses of mixing and forming better than raw, room temperature tissue would. The pieces used should also be large enough to impart a natural fish texture to the final product. The fish pieces make up the substantial, or predominant portion of the product, and as they were processed and mixed in a frozen state, much of their natural form, flavor and texture is preserved in the final product. The formed product is then put through a first cooking step to such a degree that the binder gels. The resulting seafood analog has both the look and feel of natural fish flesh, including the forkability, flakiness and eating quality of fish steaks or fillets. The amount of surimi, or gel, used is so low that the final product has none of the characteristic chewiness of typical surimi-based seafood analogs, and in fact the amount of surimi paste used is preferably so small as to be virtually undetectable by the consumer. The binder holds the pieces together and so other binders such as batter and/or breading are not necessary. Breading contributes calories and, when present, diminishes the overall appeal of such a product to health-conscious consumers. The product can be further processed after forming, such as through seasoning, marking or further cooking the product to set the surimi gel. The product can then be packaged and pasteurized. Pasteurization is a second cooking step for the product, and it is preferred that a quick chill follow the pasteurization. Ultimately, the product is distributed and sold refrigerated as a fully cooked, formed fish product. Other features and advantages of the invention will become apparent to those of ordinary skill in the art upon review of the following detailed description, claims, and drawings. DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic representation of the process set up and steps. FIG. 2 is a general schematic illustration of a seafood analog produced by the process. DESCRIPTION OF THE PREFERRED EMBODIMENT In accordance with the invention, a seafood analog 10, or imitation fish product, is comprised almost entirely of fish pieces 12 bound together by a small amount of a conventional surimi-based fish paste as a binder 14. The ratio of fish pieces to fish-paste binder should be very large, preferably on the order of ten to one, which provides a product with the texture, flakiness and forkability of true, or naturally occurring, fish steaks or fillets. The amount of binder used can be as little as is necessary to bind substantially all of the fish pieces together, while the fish pieces utilized should be as large as is practically possible, in order to preserve the look and feel of whole fish within the analog. The surimi-based binder can include seasonings or flavorings, and is preferably thinned with water, relative to other surimi-based pastes used to produce seafood analogs, so that the binder will thoroughly coat the fish pieces during mixing. More particularly, in the preferred process pieces or chunks of an inexpensive fish are mixed with a surimi-based binder in a manner to thoroughly coat the pieces and subsequently bind the pieces together when set. It is desirable that a fish without a strong flavor of its own be used, so that the flavor of the final product can be controlled, such as though seasonings or other additives incorporated into the surimi paste, permitting greater flexibility in the choice of seafood variety duplicated. Alaskan pollock is a plentiful fish which is bland in flavor, as well as a fish which may be too small for producing commercially viable steaks or fillets. Pollock is also a preferred fish for the production of surimi. The preferred imitation fish product is produced from pieces of pollock mixed with a surimi-based paste as a binder. The surimi may be pollock-based as well. The process will be described in terms of that preferred embodiment, but it should be understood that other fish types could be substituted for the pollock, and that many suitable binders could be utilized, even ones that are not based on surimi. To produce the fish pieces for the mixture, pieces are chopped from pollock or other fish type fillets arranged end to end in a frozen block. The pieces are produced by cutting crosswise against the length of the fillets in the block, in essence producing small fish steaks from the frozen block. These pieces preferably have a width of approximately 1/2 inch or greater. Chunks in the range of 1/2 to 1 inch thick have been found to work particularly well in producing imitation fish steaks or fillets having the forkability and flakiness of natural fish steaks. Smaller or narrower pieces, such as fish flakes, will not work as well, as they do not produce the desired texture in the final product. Such smaller pieces have shorter muscle fibers, and produce a final product with a mealy texture. The size of fish pieces utilized in producing the fish product may need to be adjusted, however, and the preferred dimensions would be dictated by the thickness of the formed product. The pieces should remain frozen throughout the subsequent mixing and forming steps, and preferably are not permitted to rise above 28° C. at any time during this period. The binder is a surimi or surimi-based paste and is prepared in any conventional way except that the surimi paste preferably has a higher percentage of water than that of usual surimi pastes used in producing typical surimi-based imitation seafood products. The extra water reduces the surimi paste viscosity and ensures that it will easily coat each of the fish pieces completely. It is this surimi paste which ultimately binds the fish pieces together in the final product, and so it must be well distributed. The preferred formula uses a percentage of water that is approximately half of the weight of the minced fish surimi, in this preferred embodiment utilizing 30% water with 58% surimi. The remainder of the formula comprises salt and fillers such as starch, seasonings or flavorings. The flavorings can include flavorings of other varieties of fish or shellfish, some of which are derived directly from those other varieties. Salt is a common ingredient to all surimi pastes, and is important in determining the gel strength. The salt pulls proteins from the muscle fibers. When the surimi is thoroughly minced with salt, a sticky paste is produced. The amount of salt used in producing the paste is conventional, preferably about 1.5 to 2.0% by weight. The percentage of surimi paste utilized in the mixture to be formed into fillets or steaks is in the range of about 10% to 20% by weight, with the remainder being fish pieces. Thus, the amount of salt in the final product can be as low as 1/10 of that of a typical surimi-based seafood analog. The preferred weight percentages of fish pieces and surimi paste will differ with the variety of fish used. With pollock, for example, 10% surimi paste by weight is used, with the remainder being pollock pieces, i.e., 9 to 1 pollock chunks to surimi paste. With other varieties of fish the amount of surimi paste used may need to be adjusted to achieve the best results. For cod pieces a formula utilizing 20% surimi paste is preferred, i.e. 4 to 1 cod pieces to surimi paste. As little of the surimi paste should be used as possible, however, so that the surimi paste will be virtually undetectable in the final product. The greater the amount of surimi paste that is used the more likely that the finished product will have a rubbery or gelatinous texture. The surimi paste and the fish pieces are preferably mixed in a ribbon blender 16, wherein the fish pieces are coated with the surimi paste without undue stresses being applied to the fish pieces, which stresses would otherwise be inclined to tear or shear the fish pieces. The mixing should not rupture or damage the cells of the fish pieces, leaving them relatively intact. Any conventional blending technique which does not damage the muscle fibers, or cause mashing or deformation of the fish pieces, could be utilized. Again, the temperature of the fish pieces should remain roughly 28° F. or below throughout the mixing, as above this point the fish pieces will begin to thaw and soften, which increases the likelihood of damage or deformation of the pieces from the mixing. From the ribbon blender, the coated fish pieces are transferred by conveyor to a former 18. The former can be of any conventional type and is operative to take a measured portion of the chilled mixture and press or otherwise form it into a predetermined shape. Most such formers involve the application of pressure to the mixture, so it is important that the pieces of the fish remain frozen throughout the formation process as well, again to prevent deformation or shearing of the pieces at this step. Thus, the temperature of the mixture should not exceed 28° F. until after processing in the former is completed. In a preferred embodiment the former is used to make a formed seafood product in the form of 1 inch thick fish steaks or a contoured fish fillet, although any form of a desired fish product could be utilized. Although the orientations of the pieces within the formed steaks or fillets are random, this does not diminish the flaky texture, the forkability or the natural appearance of the final product. Natural or true fish steaks are comprised of unaligned muscle portions which are orientated at varying angles throughout the product. Therefore, the random orientation of the fish pieces within the formed fish product does not significantly deter from the anticipated texture, as there is no expected muscle orientation for all of the muscle portions in the fish steak or fillet. The formed product can now have additional seasoning applied to the surface, if desired, or it can be marked, such as by running the product through a grill marker 20, which gives the appearance of a grilled product. This processing can be by any conventional means. Once the product has been formed into its final shape it can be allowed to thaw, as there are no further external stresses applied to the product during any of the steps remaining in the process. After the formed mixture has been further processed for surface variation or seasoning, it is then conveyed to an oven 22 where it is cooked to solidify, or set, the surimi-based binder throughout. The internal temperature of the product must reach approximately 140° to 160° F. in order to set the surimi binder. The formed product is cooked in a humidity-controlled oven, which can be of any conventional type. A relatively high humidity is maintained within the oven, which regulates the yield by preventing drying of the product, thus preserving a higher moisture content. The time within the oven can be adjusted in light of these desired final characteristics, in other words to accomplish the twin goals of retaining the moisture of the product and of achieving the requisite internal temperature. After processing through the humidity-controlled oven the product is fully cooked, with the thoroughly cooked fish pieces fixed within the gelled surimi paste binder. There is, therefore, no need for breading to bind the pieces together, as has been necessary in some previous fish analog products. As the product is not breaded, it need not be oiled or fried and, therefore, the final product has the desirable attribute of being relatively fat free. Further processing of the product is possible after the humidity-controlled oven. The product can have seasonings added or can be run through a grill marker, if these have not been done previously. Thus, surface variations can be achieved either before or after the humidity-controlled oven, while seasonings can be applied to the product either by being incorporated into the surimi paste binder or by being topically applied either before or after the passage of the product through the humidity-controlled oven. The product is next packaged and pasteurized at station 24. In the preferred method, this is done by placing the product into a plastic tray, flushing it with nitrogen and sealing it with a plastic sheet under partial vacuum. The vacuum-sealed package is then passed through a pasteurization oven. The pasteurization step is similar to the European cooking method of sous vide, where the product is fully cooked through pasteurization in a vacuum-sealed package, chilled and then marketed as a refrigerated product rather than frozen. The preferred method includes pasteurization at 190° to 200° F. for a predetermined time. This is a second cooking step, and the internal temperature of the fish steaks reaches about 185° F. for approximately 20 minutes. The product is cooked twice, then, once while the surimi paste binder is set, and a second time during pasteurization. The product processed to this point will have an acceptable shelf life. To further increase the shelf life of such products, this invention proposes to quickly cool the packaged product after the pasteurization step This can involve any conventional quick-chilling method, such as immediately immersing the pasteurized product in a chilled water bath 26. The faster the product goes from hot to cold, the more favorable will be the implications for shelf life. Thus pasteurization is preferably followed by a complete submersion of the packaged product in a chilled ice water bath, preferably for about 20 to 40 minutes in a bath chilled to about 32° to 38° F. Known fish analogs utilizing a single cooking step of pasteurization after packaging have a shelf life of 20 to 25 days. The two-step cooking process described actually increases the shelf life of the product to approximately 90 days. Double cooking produces a very clean product with a shelf life which permits virtually continent-wide distribution of a refrigerated, rather than frozen, product. Also, by not subjecting the final product to freezing and defrosting cycles, both the flavor and the texture of the product are better preserved. The described seafood analog is an entirely new concept in seafood products, giving the consumer a wider choice in seafood analog varieties. The pollock pieces that are used in forming this product make it economically attractive to produce and the small amount of binder utilized results in a product having the texture and forkability of ocean fish. Additionally, the formation process allows for numerous product styles, flavoring and packaging options. Although one embodiment of the present invention has been illustrated and described, it will be apparent to those skilled in the art that various changes and modifications may be made therein without departing from the spirit of the invention or from the scope of the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to tweezers and more particularly pertains to a new deplitory device for the removal of unwanted hair. 2. Description of the Prior Art The use of tweezers is known in the prior art. More specifically, tweezers heretofore devised and utilized are known to consist basically of familiar, expected and obvious structural configurations, notwithstanding the myriad of designs encompassed by the crowded prior art which have been developed for the fulfillment of countless objectives and requirements. Known prior art includes U.S. Pat. No. 5,133,722; U.S. Pat. No. 4,498,474; U.S. Pat. No. 5,971,081; U.S. Pat. No. 4,865,034; U.S. Pat. No. 2,803,252; U.S. Pat. No. 849,789; and U.S. Pat. No. Des. 138,784. While these devices fulfill their respective, particular objectives and requirements, the aforementioned patents do not disclose a new deplitory device. The inventive device includes a heatable tweezer having an upper portion containing wax that is dispensable onto a user's hair, allowing the user to utilize the tweezer to remove the cured wax thereby removing the hair from its follicle. In these respects, the deplitory device according to the present invention substantially departs from the conventional concepts and designs of the prior art, and in so doing provides an apparatus primarily developed for the purpose of the removal of unwanted hair. SUMMARY OF THE INVENTION In view of the foregoing disadvantages inherent in the known types of tweezers now present in the prior art, the present invention provides a new deplitory device construction wherein the same can be utilized for the removal of unwanted hair. The general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new deplitory device apparatus and method which has many of the advantages of the tweezers mentioned heretofore and many novel features that result in a new deplitory device which is not anticipated, rendered obvious, suggested, or even implied by any of the prior art tweezers, either alone or in any combination thereof. To attain this, the present invention generally comprises a heatable tweezer having an upper portion containing wax that is dispensable onto a user's hair, allowing the user to utilize the tweezer to remove the cured wax thereby removing the hair from its follicle. There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood, and in order that the present contribution to the art may be better appreciated. There are additional features of the invention that will be described hereinafter and which will form the subject matter of the claims appended hereto. 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. As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way. It is therefore an object of the present invention to provide a new deplitory device apparatus and method which has many of the advantages of the tweezers mentioned heretofore and many novel features that result in a new deplitory device which is not anticipated, rendered obvious, suggested, or even implied by any of the prior art tweezers, either alone or in any combination thereof. It is another object of the present invention to provide a new deplitory device which may be easily and efficiently manufactured and marketed. It is a further object of the present invention to provide a new deplitory device which is of a durable and reliable construction. An even further object of the present invention is to provide a new deplitory device which is susceptible of a low cost of manufacture with regard to both materials and labor, and which accordingly is then susceptible of low prices of sale to the consuming public, thereby making such deplitory device economically available to the buying public. Still yet another object of the present invention is to provide a new deplitory device which provides in the apparatuses and methods of the prior art some of the advantages thereof, while simultaneously overcoming some of the disadvantages normally associated therewith. Still another object of the present invention is to provide a new deplitory device for the removal of unwanted hair. Yet another object of the present invention is to provide a new deplitory device which includes a heatable tweezer having an upper portion containing wax that is dispensable onto a user's hair, allowing the user to utilize the tweezer to remove the cured wax thereby removing the hair from its follicle. Still yet another object of the present invention is to provide a new deplitory device that utilizes self-contained wax to remove hair. These together with other objects of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be made to the accompanying drawings and descriptive matter in which there are illustrated preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: FIG. 1 is a schematic top view of a new deplitory device according to the present invention. FIG. 2 is a schematic end view of the present invention. FIG. 3 is a schematic cross-sectional view of the present invention. FIG. 4 is a schematic perspective view of the present invention in use. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference now to the drawings, and in particular to FIGS. 1 through 4 thereof, a new deplitory device embodying the principles and concepts of the present invention and generally designated by the reference numeral 10 will be described. As best illustrated in FIGS. 1 through 4, the deplitory device 10 generally comprises a tweezer 12 . The tweezer 12 comprises an upper portion 14 and a lower portion 16 . The tweezer 12 is heatable such that wax 18 contained in the upper portion 14 is dispensable onto the skin 20 of a user around a hair 21 . Upon curing of the wax 18 , the tweezer 12 is used to remove the wax 18 thereby removing the hair 21 from its follicle. The portions 14 , 16 of the tweezer 12 are integrally joined to form the tweezer 12 . Each of the portions 14 , 16 has a distal end 24 . The distal ends 24 of the portions 14 , 16 are designed for grasping onto a hair 21 for the purpose of removing the hair 21 . The upper portion 14 of the tweezer 12 has a wax cavity 26 . The wax cavity 26 is integrally formed within the upper portion 14 such that the wax cavity 26 is designed for the holding and dispensing of the wax 18 . The upper portion 14 of the tweezer 12 has a wax plunger 28 . The wax plunger 28 is slidably coupled to the upper portion 14 of the tweezer 12 . The wax plunger 28 is in contact with the wax 18 in the wax cavity 26 of the upper portion 14 such that the wax plunger 28 is designed for biasing the wax 18 in the wax cavity 26 towards the distal end 24 of the upper portion 14 . The upper portion 14 of the tweezer 12 has a wax aperture 30 . The wax aperture 30 is positioned on an end surface 32 of the distal end 24 of the upper portion 14 . The wax aperture 30 is designed for allowing melted wax 18 to be dispensed from the upper portion 14 of the tweezer 12 when the wax 18 is biased towards the distal end 24 of the upper portion 14 by the wax plunger 28 . This allows the user to utilize the wax 18 cured around a hair 21 in conjunction with the tweezer 12 to remove the hair 21 from its follicle. As to a further discussion of the manner of usage and operation of the present invention, the same should be apparent from the above description. Accordingly, no further discussion relating to the manner of usage and operation will be provided. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

1a

REFERENCE TO RELATED APPLICATIONS This application claims the priority benefit of Korean Patent Application No. 10-2015-0011241 filed on Jan. 23, 2015, the entire contents of which are incorporated herein by reference. FIELD OF THE INVENTION The present invention relates to a method of neutralizing an amine gas odor in a cold box process and a gas generator using the method. More particularly, the present invention relates to a method of neutralizing an amine gas odor in a cold box process that injects an odor neutralizer for an amine gas after hardening in order to reduce the amine gas odor that remains or leaks through a gap of a mold in the processing of manufacturing a core or a mold, and an amine gas generator using the method. BACKGROUND OF THE INVENTION A mold used for making the shape of a hole for manufacturing a hollow part such as a column in general casting is called a core. Casting for manufacturing a hollow cast is made by putting a core into a mold, injecting molten metal into the mold, taking out the cast and the core from the mold after the molten metal hardens, and then separating the core from the cast. A core or a mold for casting is manufactured, for example, by making molding sand, in which dry sand and a plurality of forming resins are uniformly mulled by a mixer, putting the molding sand into a mold, hardening the molding sand by injecting an amine gas into the molding sand in the mold, and taking out the hardened object. Such a technique has been disclosed in Korean Patent No. 10-1131033, titled “Use of amine blends for foundry shaped cores and casting metals”. In this related art, phenolic resin and polyisocyanate are used as a forming resin, and molding sand is obtained by mixing the forming resin with sand. The molding sand is hardened at room temperature, using an amine blend as a hardener and a core or a mold made of polyurethane can be obtained through the hardening. This process is called a PUCB (Polyurethane Cold Box) process. Hardening a core or a mold using an amine gas has various advantages, for example: it can be hardened at room temperature without heating at a high temperature, the hardening speed is higher than high-temperature hardening, and not only the surface of molding sand, but the entirety of the molding sand can be hardened. However, when an amine gas is used as a hardener, a worker may have difficulty in working due to the amine gas odor remaining after hardening or due to an amine gas leak through a gap of a mold. Documents of Related Art (Patent Document 1) Korean Patent No. 10-1131033 (Patent Document 2) Korean Patent Application Publication No. 10-2009-0011520 SUMMARY OF THE INVENTION Accordingly, the present invention has been made keeping in mind the above problems occurring in the related art, and the present invention is intended to propose a method of neutralizing the odor of an amine gas for a cold box process that injects an odor neutralizer for an amine gas after hardening in order to reduce the odor of an amine gas that remains or leaks through a gap of a molding in a processing of manufacturing a core or a mold, and an amine gas generator using the method. Further, the present invention provides a method of neutralizing an odor of an amine gas for a cold box process that can simply remove an odor by injecting an odor neutralizer directly into a mold simultaneously with discharge of an amine gas, and an amine gas generator using the method. In order to achieve the objects of the present invention, there is provided a method of neutralizing an odor of an amine gas for a cold box process that includes: making molding sand by mixing sand and forming resin; putting the molding sand into a mold; hardening the molding sand by injecting an amine gas into the molding sand in the mold; and removing an amine gas odor remaining in the mold by injecting an amine gas odor neutralizer into the mold. In the removing the amine gas odor, the odor neutralizer may be injected into the mold simultaneously with discharging of the amine gas to the outside from the mold and an amount of the odor neutralizer injected may be 5 to 15 parts by weight based on 100 parts by weight of the amine gas. In order to achieve the objects of the present invention, there is provided an amine gas generator that includes: an amine supplier supplying a stored amine gas; an odor neutralizer supplier supplying an odor neutralizer for removing the amine gas odor; an injection line through which the amine gas or the odor neutralizer is injected with compressed air into a mold; a regulator disposed in the injection line and maintaining an injection pressure of the compressed air at a predetermined level; a first valve disposed between the amine supplier and the injection line and stopping or passing the amine gas; and a second valve disposed between the odor neutralizer supplier and the injection line and stopping or passing the odor neutralizer. The injection line may be divided into a gassing line through which the amine gas is injected with heated-compressed air into the mold and a purging line through which the odor neutralizer is injected with heated-compressed air into the mold, and the regulator may be composed of a first regulator disposed in the gassing line and maintaining injection pressures of the amine gas and the compressed air at predetermined level and a second regulator disposed in the purging line and maintaining injection pressures of the odor neutralizer and the compressed air at predetermined levels. The amine gas generator may further include a third valve disposed in the gassing line and stopping or passing the compressed air and a fourth valve disposed in the purging line and stopping or passing the compressed air, and may further include a first check cylinder disposed in the gassing line for checking a supply amount of the amine gas and a fourth valve disposed in the purging line for checking a supply amount of the odor neutralizer, and the second valve may open simultaneously with closing of the first valve so that the odor neutralizer is supplied. The first valve may have a first valve timer for adjusting opening and closing of the first valve at predetermined times and the second valve may have a second valve timer for adjusting opening and closing of the second valve at predetermined times. The amine gas generator may further include an air tank supplying the compressed air and an air heater heating the compressed air discharged from the air tank at 40 to 100° C. According to the present invention, it is possible to inject an amine gas odor neutralizer after hardening in order to reduce the amine gas odor that remains and leaks through a gap of a mold in a process of manufacturing a core or a mold. Further, an odor neutralizer is immediately injected simultaneously with discharging of an amine gas, so it is possible to simply remove an amine gas odor. BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects, features and other advantages of the present invention will be more clearly understood from the following detailed description when taken in conjunction with the accompanying drawings, in which: FIG. 1 is a view of an amine gas generator according to a first embodiment of the present invention; FIG. 2 is a view of an amine gas generator according to a second embodiment of the present invention; and FIG. 3 is a flowchart illustrating a method of neutralizing an amine gas odor according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION Hereinafter, a method of neutralizing an amine gas odor for a cold box process according to the present invention and amine gas generators 100 and 200 using the method will be described in detail with reference to the accompanying drawings. First, as shown in FIG. 1 , an amine gas generator 100 according to a first embodiment includes an amine gas supplier 110 storing an amine gas, an odor neutralizer supplier 120 supplying an amine gas odor neutralizer, and a gassing line 130 and a purging line 140 through which an amine gas is injected into a mold 10 . An amine gas in the amine gas supplier 110 is supplied to the mold 10 through the gassing line 130 . A first regulator 131 connected to an air tank 150 and receiving compressed air from the air tank 150 to maintain the pressure of injected amine gas at a predetermined level is disposed in the gassing line 130 . As compressed air passes through the first regulator 131 from the air tank 150 for supplying the compressed air, the first regulator 131 adjusts the pressure of the compressed air to a predetermined level, and when the compressed air is sent into the mold 10 , an amine gas is supplied into the mold 10 with the compressed air by the pressure of the compressed air. The generator further includes an air heater 151 that heats the compressed air from the air tank 150 at 40 to 100° C., when it flows into the gassing line 130 . When the temperature of the compressed air is lower than 40° C., an odor neutralizer may turn to liquid, and when it is higher than 100° C., the amine generator 100 may be damaged. Accordingly, it is important to maintain and supply compressed air at an appropriate temperature using the air heater 151 . A first valve 133 stopping/passing an amine gas is disposed between the amine supplier 110 and the gassing line 130 . When the first valve 133 is open, an amine gas is supplied to the gassing line 130 from the amine generator 110 , and when the first valve 133 is closed, an amine gas is not supplied to the gassing line 130 from the amine supplier 110 . The first valve 133 has a first valve timer 133 a that opens/closes the first valve at predetermined times. A third valve 135 that opens/closes the gassing line 130 is disposed in the gassing line 130 . The third valve 135 opens or closes to adjust the amount of the compressed air that has passed through the first regulator 131 , so the compressed air and the amine gas that are supplied into the mold 10 are adjusted. The third valve 135 may have a third valve timer 135 a that controls opening/closing of the third valve 135 at predetermined times. The supply amount of an amine gas adjusted by the first valve 133 can be checked through a first check cylinder, if necessary. The check cylinder comes from the gassing line 130 and it is possible to check the supply amount of an amine gas in real time, using a graduation marked on the first check cylinder. A second regulator 141 that maintains the compressed air from the air tank 150 at a predetermined pressure is disposed in the purging line 140 . Similar to the first regulator 131 , as compressed air passes through the second regulator 141 from the air tank 150 , the second regulator 131 adjusts the pressure of the compressed air to a predetermined level, and when the compressed air is sent into the mold 10 , an odor neutralizer is supplied into the mold 10 with the compressed air by the pressure of the compressed air. A second valve 143 stopping/passing an odor neutralizer is disposed between the amine neutralizer supplier 120 and the purging line 140 . Similar to the first valve 133 , when the second valve 143 is open, an odor neutralizer is supplied into the purging line 140 , and when the second valve 143 is closed, an odor neutralizer is not supplied. The second valve 143 , similar to the first valve 133 , has a second valve timer 143 a. A fourth valve 145 that opens/closes the purging line 140 is disposed in the purging line 140 . The fourth valve 145 adjusts supply and stoppage of the compressed air that has passed through the second regulator 141 . The fourth valve 145 may have a fourth valve timer 145 a that controls opening/closing of the fourth valve 145 . The supply amount of the odor neutralizer adjusted by the third valve 143 and the fourth valve 145 can be checked by the second check cylinder, similar to the first check cylinder. When the amount of an amine gas supplied to the mold 10 and checked through the first check cylinder reaches to a predetermined level, the supply of the amine gas is stopped by the first valve 133 or the third valve 135 . Further, when the information about the supply amount of the amine gas is transmitted to a controller 160 or a user inputs it to the controller 160 , the controller 160 sends a signal to the second valve 143 or the fourth valve 145 so operate them. When the supply of the amine gas is stopped, the compressed air and the odor neutralizer are injected into the mold 10 . The second valve 143 or the fourth valve 145 may operate such that the odor neutralizer is injected in an amount of 5 to 15 parts by weight based on 100 parts by weight of amine gas. When the amount of the odor neutralizer injected is less than 5 parts by weight, it cannot sufficiently neutralize remaining amine gas, and when the amount of the odor neutralizer injected is more than 15 parts by weight, it can sufficiently remove the odor of amine gas, but the cost is high. Accordingly, the odor neutralizer may be injected in the amount of 5 to 15 parts by weight based on 100 parts by weight of amine gas An amine gas generator 200 of a second embodiment is the same as the first embodiment in the configuration of the amine supplier 210 and the odor neutralizer supplier 220 , but different in that the gassing line 130 and the purging line 140 are integrated into one injection line 230 . An amine gas in the amine gas supplier 210 is supplied to the mold 10 through the injection line 230 . A regulator 230 connected to an air tank 250 to maintain the injection pressure of the amine gas at a predetermined level and receiving compressed air heated by the air tank 250 and an air heater 251 is disposed in injection line 230 . When compressed air is supplied into the mold 10 through the regulator 231 , an amine gas is supplied into the mold 10 or stopped by the amine supplier 210 and the first valve 233 in the injection line 230 . The odor neutralizer to be supplied to the injection line 230 is adjusted by a second valve 235 disposed between the odor neutralizer supplier 220 and the injection line 230 and stopping/passing the odor neutralizer. When a necessary amount of an amine gas is injected into the mold 10 , the supply of the amine gas to the injection line 230 through the first valve 233 is stopped and the second valve 235 is opened, so the odor neutralizer is injected with compressed air into the mold 10 and neutralizes the amine gas odor. The first valve 233 and the second valve 235 may be simultaneously controlled by a controller 260 . The first valve 233 and the second valve 235 may have a first valve timer 233 a and a second valve timer 235 a , respectively. In the related art, when an amine gas supply is stopped, only compressed air is supplied into the mold 10 to discharge the amine gas in the mold to the outside. However, when only compressed air is supplied, as described above, the amine gas remaining in the mold 10 and the amine gas leaking through a gap of the mold gives off a bad smell, so a worker feels discomfort. However, according to the present invention, it is possible to reduce an amine gas odor by supplying an odor neutralizer with compressed air. A method of neutralizing an amine gas using the amine gas generators 100 and 200 is as follows. As shown in FIG. 2 , molding sand 30 is made by mixing sand and forming resin (S 1 ). The sand and the forming resin are used as materials for manufacturing a core or a molding and they are mulled by a blender such as a mixer, thereby making the molding sand 30 . The molding sand 30 is put into the mold 10 (S 2 ). The molding sand composed of the sand and the forming resin is put into the mold 10 fitting to the shape of a core or a mold. The mold 10 is divided left and right and the molding sand 30 is put into the mold 30 through the upper portion of the mold 10 . An amine gas or an odor neutralizer is also injected through the portion for injecting the molding sand 30 . The molding sand 30 is hardened by injecting an amine gas into the mold 10 (S 3 ). Compressed air and an amine gas are injected into the mold 10 having the shape of a core or a mold and filled with the molding sand 30 , through the same inlet of the mold 10 . When the amine gas is injected as a catalyst for the molding sand 30 composed of the sand and the forming resin, the forming resin hardens by reacting with the amine gas. When the molding sand is hardened by amine gas, a core or a mold made of polyurethane can be finally obtained. The amine gas odor is removed by injecting an odor neutralizer (S 4 ). After the molding sand 30 hardens in the mold 10 , the amine gas is discharged into a neutralizing tank 50 , and is then neutralized in the neutralizing tank 50 and discharged to the atmosphere. Some of the amine gas may remain in the mold 10 or the amine gas may leak through a gap of the mold 10 while it flows into the neutralizing tank 50 , and in this case, the amine gas emits a bad smell discomforting a worker. Accordingly, with discharging of the amine gas, compressed air and an odor neutralizer are injected into the mold 10 through the inlet through which the amine gas was injected. When an odor neutralizer is injected through the inlet of the mold 10 , it neutralizes the amine gas remaining in the mold 10 or in the gap of the mold 10 , so the distinct odor of ammonia is reduced. Accordingly, a worker does not feel excessively uncomfortable. Since the odor neutralizer is injected into the mold 10 simultaneously with discharging of the amine gas, there is no additional step and there is no difference between the process time and the process times of the related art, so a worker is not troubled. In some cases, it may be possible to additionally neutralize the amine gas discharged to the atmosphere through the neutralizing tank 50 by additionally installing the odor neutralizer supplier 120 to the neutralizing tank 50 . The odor neutralizer may be injected in an amount of 5 to 15 parts by weight based on 100 parts by weight of the amine gas. When the amount of the odor neutralizer injected is less than 5 parts by weight, it cannot sufficiently neutralize the remaining amine gas, and when the amount of the odor neutralizer injected is more than 15 parts by weight, the odor neutralizer is too much in comparison to the remaining amine gas, so the odor neutralizer may be wasted. When the amine gas in the mold 10 or in a gap of the mold 10 remains, a worker may be discomforted by the gas odor. However, as in the present invention, when an odor neutralizer is injected into the mold 10 , it neutralizes the amine gas remaining in the mold 10 or in the gap, so a worker can more easily work. Further, since the process of injecting an odor neutralizer is performed simultaneously with discharging of the amine gas from the mold 10 , there is no need for an additional process and the work time does not increase, so it is efficient. Although a preferred embodiment of the present invention has been described for illustrative purposes, those skilled in the art will appreciate that various modifications, additions and substitutions are possible, without departing from the scope and spirit of the invention as disclosed in the accompanying claims.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of and claims the benefit and priority of U.S. Utility application Ser. No. 12/028,771 filed on Feb. 8, 2008, which claims priority to the U.S. Provisional Patent application No. 60/900,550 filed on Feb. 8, 2007, the disclosures of which are incorporated herein by reference. FIELD OF THE INVENTION [0002] This invention pertains to methods and pharmaceutical formulations for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine, i.e., imiquimod. More particularly, it pertains to creams, ointments, foams, gels, lotions, pressure sensitive adhesive coatings and adhesive-coated sheet materials, which contain imiquimod, that enhance skin penetration of drugs to treat dermatological disorders, namely, viral infections, such as Type I or Type II Herpes simplex infections and genital warts, actinic keratosis and superficial basal cell carcinoma, and to induce interferon biosynthesis, with shorter durations of therapy, than currently approved for imiquimod by the Food & Drug Administration (“FDA”). BACKGROUND [0003] The compound 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine, known as imiquimod and commercially marketed in the U.S. under the brand name Aldara®, is disclosed in U.S. Pat. No. 4,689,338 and described therein as an antiviral agent and as an interferon inducer, which is incorporated herein by reference in its entirety. A variety of formulations for topical administration of imiquimod are also described therein. This U.S. Pat. No. 4,689,338 is incorporated herein by reference in its entirety [0004] U.S. Pat. No. 4,751,087 discloses the use of a combination of ethyl oleate and glyceryl monolaurate as a skin penetration enhancer for nitroglycerine, with all three components being contained in the adhesive layer of a transdermal patch, wherein this U.S. patent is incorporated herein by reference in its entirety. [0005] U.S. Pat. No. 4,411,893 discloses the use of N,N-dimethyldodecylamine-Noxide as a skin penetration enhancer in aqueous systems, wherein this U.S. patent is incorporated herein by reference in its entirety. [0006] U.S. Pat. No. 4,722,941 discloses readily absorbable pharmaceutical compositions that comprise a pharmacologically active agent distributed in a vehicle comprising an absorption-enhancing amount of at least one fatty acid containing 6 to 12 carbon atoms and optionally a fatty acid monoglyceride. Such compositions are said to be particularly useful for increasing the absorption of pharmacologically active bases, wherein this U.S. patent is incorporated herein by reference in its entirety. [0007] U.S. Pat. No. 4,746,515 discloses a method of using glyceryl monolaurate to enhance the transdermal flux of a transdermally deliverable drug through intact skin, wherein this U.S. patent is incorporated herein by reference in its entirety. [0008] U.S. Pat. No. 5,238,944 discloses topical formulations and transdermal delivery systems containing 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine, wherein this U.S. patent is incorporated herein by reference in its entirety. SUMMARY OF THE INVENTION [0009] The present invention provides a substantially non-irritating pharmaceutical formulation for topical and/or transdermal administration of the imiquimod, which formulation comprises: [0000] a) 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine, i.e., imiquimod, in an amount of about 2 percent to about 4 percent by weight based on the total weight of the formulation; and b) a pharmaceutically acceptable vehicle for imiquimod, which vehicle comprises a fatty acid, such as isostearic acid, linoleic acid, oleic acid, super purified oleic acid (an oleic acid having low polar impurities such as peroxides) and a combination thereof, in a total amount of about 3 percent to about 45 percent by weight based on the total weight of the formulation. The formulation is further characterized in that when tested in the hairless mouse skin model described in U.S. Pat. No. 5,238,944, the formulation provides a penetration of the agent of at least about 10% (and preferably at least about 15%) of the total amount of the agent contained in the formulation in 24 hours. [0010] The salient elements of a pharmaceutical formulation according to the invention are (a) imiquimod and (b) a fatty acid, e.g., isostearic, linoleic, super purified oleic or oleic acid and mixtures thereof. A pharmaceutical formulation of the invention can be in any form known to the art, such as a cream, an ointment, a foam, a gel, a lotion or a pressure-sensitive adhesive composition, each form containing the necessary elements in particular amounts and further containing various additional elements. [0011] A cream of the invention preferably contains about 2 percent to about 4 percent by weight of imiquimod based on the total weight of the cream; about 5 percent to about 25 percent by weight of fatty acid, based on the total weight of the cream; and optional ingredients such as emollients, emulsifiers, thickeners, and/or preservatives. [0012] An ointment of the invention contains an ointment base in addition to imiquimod and fatty acid. An ointment of the invention preferably contains about 2 percent to about 4 percent by weight imiquimod; about 3 percent to about 45 percent, more preferably about 3 percent to about 25 percent by weight fatty acid; and about 40 percent to about 95 percent by weight ointment base, all weights being based on the total weight of the ointment. Optionally, an ointment of the invention can also contain emulsifiers, emollients and thickeners. [0013] A pressure-sensitive adhesive composition of the invention contains imiquimod, fatty acid, and an adhesive. The adhesives utilized in a pressure sensitive adhesive composition of the invention are preferably substantially chemically inert to imiquimod. [0000] A pressure sensitive adhesive composition of the invention preferably contains about 2 percent to about 4 percent by weight imiquimod; about 10 percent to about 40 percent by weight, more preferably of about 15 percent to about 30 percent by weight, and most preferably about 20 percent to about 30 percent by weight of fatty acid; all weights being based on the total weight of the pressure sensitive adhesive composition. [0014] Optionally, pressure sensitive adhesive compositions of the invention can also contain one or more skin penetration enhancers. The total amount of skin penetration enhancer(s) present in a pressure sensitive adhesive composition of the invention is preferably about 3 percent to about 25 percent by weight, and more preferably about 3 percent to about 10 percent by weight based on the total weight of the pressure sensitive adhesive composition. [0015] A pressure sensitive adhesive coated sheet material of the invention can be made from a pressure-sensitive adhesive composition of the invention in the form of an article such as a tape, a patch, a sheet, or a dressing. [0016] A formulation of the present invention may be used to topically and/or transdermally administer imiquimod for effectively treating viral infections, for example, Type I or Type II Herpes simplex infections, actinic keratosis and superficial basal cell carcinoma for a shorter duration of time and with the same or increased number of applications per week, as compared to current imiquimod topical therapy. [0017] For example, a formulation of the present invention containing between greater than about 1% and about 5% imiquimod may be applied from three to seven times per week (once per day) for 8 to 12 weeks to treat viral infections, for example, Type I or Type II Herpes simplex infections, actinic keratosis and superficial basal cell carcinoma. It should be understood that while formulations of the present invention containing between greater than about 1% and about 5% imiquimod are preferred, formulations containing about 2.5%, 2.75%, 3.0%, 3.25%, 3.5%, 3.75%, 4.0%, 4.25% and 4.5% are more preferred and that formulations containing about 2.75%, 3.0%, 3.25%, 3.5%, 3.75% and 4.0% are most preferred. [0018] As to duration, the present invention contemplates applying an effective amount of imiquimod for a shorter period of time than currently approved by the FDA. More specifically, the present invention contemplates applying an effective amount of imiquimod from three to seven times or more per week to an area in need of imiquimod treatment for about 8 to about 12 weeks, and more preferably between about 4, about 5, about 6 and about 7 times a week for about 8, about 9 or about 10 weeks. [0019] While the present invention has identified what it believes to be preferred concentrations of imiquimod, numbers of applications per week and durations of therapy, it should be understood by those versed in this art that any effective concentration of imiquimod in a formulation and any numbers of application per week that can accomplish a reduction in therapy duration to effectively treat Type I or Type II Herpes Simplex infections, actinic kurtosis and superficial basal cell carcinoma or induce effective interferon biosynthesis is contemplated by the present invention. DETAILED DESCRIPTION OF THE INVENTION [0020] As used in the specification and claims, the phrase “substantially non-irritating” designates formulations that do not cause unacceptable skin irritation in conventional repeat skin irritation tests in albino rabbits such as that described in Raise et al., “Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics”, prepared by the Division of Pharmacology of the Food and Drug Administration, published originally in 1959 by the Association of Food and Drug Officials of the United States, Topeka, Kans. (2nd printing 1965), incorporated herein by reference. [0021] The present invention provides pharmaceutical formulations such as creams, ointments, foams, gels, lotions and adhesive coatings that contain imiquimod and a fatty acid such as isostearic, linoleic, super purified oleic acid or oleic acid and mixtures thereof. The formulations of the invention provide desirable skin penetrability of the imiquimod. [0022] The compound imiquimod is a known antiviral agent that is also known to induce interferon biosynthesis. It can be prepared using the method disclosed in U.S. Pat. No. 4,689,338, the disclosure of which is incorporated herein by reference. The compound can be used to treat viral infections such as Type I or Type II Herpes simplex infections and genital warts. Furthermore, the fact that the compound is an interferon inducer suggests that it, and therefore formulations containing it, might be useful in the treatment of numerous other diseases, such as rheumatoid arthritis, warts, eczema, hepatitis B, psoriasis, multiple sclerosis, essential thrombocythaemia, and cancer, such as basal cell carcinoma and other neoplastic diseases. The amount of imiquimod present in a formulation of the invention will be an amount effective to treat the targeted disease state to prevent the recurrence of such a disease or to promote immunity against such a disease. The amount is preferably about 0.5 percent to about 9 percent by weight based on the total weight of a formulation, more preferably between greater than about 1% and about 5% imiquimod, and more preferably between about 2.5%, 2.75%, 3.0%, 3.25%, 3.5%, 3.75%, 4.0%, 4.25% and 4.5%, and most preferred between about 2.75%, 3.0%, 3.25%, 3.5%, 3.75% and 4.0%. [0023] A fatty acid such as isostearic acid, linoleic acid, super purified oleic acid, oleic acid or a mixture thereof is incorporated into a formulation of the invention. The total amount of fatty acid present in a formulation is preferably about 3 percent to about 45 percent by weight based on the total weight of a formulation. It should be understood that when oleic acid is selected as a fatty acid, that stability may present issue. Thus, stabilizers, such as anti-oxidants and the like, may be required to preserve pharmaceutical elegance and stability over the life of the oleic formulation. [0024] A pharmaceutical formulation of the invention can be in a form such as a cream, an ointment, a foam, a gel, a lotion, a pressure-sensitive adhesive composition, or other forms known to those skilled in the art, each particular form containing imiquimod and fatty acid in particular amounts, and optionally containing various additional elements. The preferred amounts of drug and fatty acid, and the amounts and types of optional elements used in formulations of the invention are discussed below with particular reference to creams, ointments and adhesive compositions. [0025] A cream according to the invention contains 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine and fatty acid. [0026] The amount of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine present in a cream is preferably about 0.5 percent to about 9 percent by weight, and more preferably about 1 percent to about 5 percent by weight, based on the total weight of the cream. [0027] The total amount of fatty acid present in a cream of the invention is preferably about 3 percent to about 45 percent by weight, and more preferably about 5 percent to about 25 percent by weight, based on the total weight of the cream. [0028] Optionally, a cream of the invention can contain emollients, emulsifiers, thickeners, and/or preservatives. [0029] Emollients such as long chain alcohols, e.g., cetyl alcohol, stearyl alcohol and cetearyl alcohol; hydrocarbons such as petrolatum and light mineral oil; or acetylated lanolin can be included in a cream of the invention. A cream can contain one or more of these emollients. The total amount of emollient in a cream of the invention is preferably about 5 percent to about 30 percent, and more preferably about 5 percent to about 10 percent by weight based on the total weight of the cream. [0030] Emulsifiers such as nonionic surface active agents, e.g., polysorbate 60 (available from ICI Americas), sorbitan monostearate, polyglyceryl-4 oleate, and polyoxyethylene(4)lauryl ether or trivalent cationic a cream of the invention. A cream can contain one or more emulsifiers. Generally the total amount of emulsifier is preferably about 2 percent to about 14 percent, and more preferably about 2 percent to about 6 percent by weight based on the total weight of the cream. [0031] Pharmaceutically acceptable thickeners, such as Veegum™K (available from R. T. Vanderbilt Company, Inc.), and long chain alcohols (i.e. cetyl alcohol, stearyl alcohol or cetearyl alcohol) can be used. A cream can contain one or more thickeners. The total amount of thickener present is preferably about 3 percent to about 12 percent by weight based on the total weight of the cream. [0032] Preservatives such as methylparaben, propylparaben and benzyl alcohol can be present in a cream of the invention. The appropriate amount of such preservative(s) is known to those skilled in the art. [0033] Optionally, an additional solubilizing agent such as benzyl alcohol, lactic acid, acetic acid, stearic acid or hydrochloric acid can be included in a cream of the invention. [0034] If an additional solubilizing agent is used, the amount present is preferably about 1 percent to about 12 percent by weight based on the total weight of the cream. [0035] Optionally, a cream of the invention can contain a humectant such as glycerin, skin penetration enhancers such as butyl stearate, and additional solubilizing agents. [0036] It is known to those skilled in the art that a single ingredient can perform more than one function in a cream, i.e., cetyl alcohol can serve both as an emollient and as a thickener. [0037] Generally, a cream consists of an oil phase and a water phase mixed together to form an emulsion. Preferably, the amount of water present in a cream of the invention is about 45 percent to about 85 percent by weight based on the total weight of the cream. [0038] The oil phase of a cream of the invention can be prepared by first combining the 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine and the fatty acid (if the cream contains benzyl alcohol it can also be added at this point) and heating with occasional stirring to a temperature of about 50° C. to 85° C. When the 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine appears to be completely dissolved, the remaining oil phase ingredients are added and heating is continued until dissolution appears to be complete. [0039] The water phase can be prepared by combining all other ingredients and heating with stirring until dissolution appears to be complete. [0040] The creams of the invention are generally prepared by adding the water phase to the oil phase with both phases at a temperature of about 65° C. to 75° C. The resulting emulsion is mixed with a suitable mixer apparatus to give the desired cream. [0041] An ointment of the invention contains an ointment base in addition to 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine and fatty acid. [0042] The amount of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine present in an ointment of the invention is preferably about 0.5 percent to about 9 percent, and more preferably about 0.5 percent to about 5 percent by weight based on the total weight of the ointment. [0043] The total amount of fatty acid present in an ointment of the invention is preferably about 3 percent to about 45 percent, and more preferably about 3 percent to about 25 percent based on the total weight of the ointment. [0044] A pharmaceutically acceptable ointment base such as petrolatum or polyethylene glycol 400 (available from Union Carbide) in combination with polyethylene glycol 3350 (available from Union Carbide) can be used. The amount of ointment base present in an ointment of the invention is preferably about 60 percent to about 95 percent by weight based on the total weight of ointment. [0045] Optionally, an ointment of the invention can also contain emollients, emulsifiers and thickeners. The emollients, emulsifiers, and thickeners and the preferred amounts thereof described above in connection with creams are also generally suitable for use in an ointment of the invention. [0046] An ointment according to the invention can be prepared by combining 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine with fatty acid and heating with occasional stirring to a temperature of about 65° C. When the 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine appears to be completely dissolved, the remaining ingredients are added and heated to about 65° C. The resulting mixture is mixed with a suitable mixer while being allowed to cool to room temperature. [0047] A pressure-sensitive adhesive composition of the invention contains 1-isobutyl 1H-imidazo[4,5-c]-quinolin-4-amine, fatty acid, and a pressure sensitive adhesive polymer. [0048] The amount of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine present in a pressure sensitive adhesive composition of the invention is preferably about 0.5 percent to about 9 percent by weight, and more preferably about 3 percent to about 7 percent by weight based on the total weight of the adhesive composition. The amount of fatty acid present is preferably about 10 percent to about 40 percent by weight, more preferably about 15 percent to about 30 percent by weight, and most preferably about 20 percent to about 30 percent by weight, based on the total weight of the adhesive composition. [0049] Preferably, the adhesive polymer utilized in a pressure sensitive adhesive composition of the invention is substantially chemically inert to 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine. The adhesive polymer is preferably present in an amount of about 55 percent to about 85 percent by weight based on the total weight of the composition. Suitable adhesive polymers include acrylic adhesives that contain, as a major constituent (i.e., at least about 80 percent by weight of all monomers in the polymer), a hydrophobic monomeric acrylic or methacrylic acid ester of an alkyl alcohol, the alkyl alcohol containing 4 to 10 carbon atoms. Examples of suitable monomers are those discussed below in connection with the “A Monomer”. These adhesive polymers can further contain minor amounts of other monomers such as the “B Monomers” listed below. [0050] Preferred adhesives include acrylic pressure-sensitive adhesive copolymers containing A and B Monomers as follows: Monomer A is a hydrophobic monomeric acrylic or methacrylic acid ester of an alkyl alcohol, the alkyl alcohol containing 4 to 10 carbon atoms, preferably 6 to 10 carbon atoms, more preferably 6 to 8 carbon atoms, and most preferably 8 carbon atoms. Examples of suitable A Monomers are n-butyl, n-pentyl, n-hexyl, isoheptyl, n-nonyl, n-decyl, isohexyl, 2-ethyloctyl, isooctyl and 2-ethylhexyl acrylates. The most preferred A Monomer is isooctyl acrylate. [0051] Monomer B is a reinforcing monomer selected from the group consisting of acrylic acid; methacrylic acid; alkyl acrylates and methacrylates containing 1 to 3 carbon atoms in the alkyl group; acrylamide; methacrylamide; lower alkyl-substituted acrylamides (i.e., the alkyl group containing 1 to 4 carbon atoms) such as tertiary-butyl acrylamide; diacetone acrylamide; n-vinyl-2-pyrrolidone; vinyl ethers such as vinyl tertiary-butyl ether; substituted ethylenes such as derivatives of maleic anhydride, dimethyl itaconate and monoethyl formate and vinyl perfluoro-n-butyrate. The preferred B Monomers are acrylic acid, methacrylic acid, the above-described alkyl acrylates and methacrylates, acrylamide, methacrylamide, and the above-described lower alkyl substituted acrylamides. The most preferred B Monomer is acrylamide. [0052] In one embodiment of a pressure-sensitive adhesive composition of the invention, the pressure-sensitive adhesive copolymer containing A and B Monomers as set forth above preferably contains the A Monomer in an amount by weight of about 80 percent to about 98 percent of the total weight of all monomers in the copolymer. The A Monomer is more preferably present in an amount by weight of about 88 percent to about 98 percent, and is most preferably present in an amount by weight of about 91 percent to about 98 percent. The B Monomer in such a copolymer is preferably present in the pressure-sensitive adhesive copolymer in an amount by weight of about 2 percent to about 20 percent, more preferably about 2 percent to about 12 percent, and most preferably 2 to 9 percent of the total weight of the monomers in the copolymer. [0053] In another embodiment of a pressure-sensitive adhesive composition of the invention, the adhesive copolymer comprises about 60 to about 80 percent by weight (and preferably about 70 to about 80 percent by weight) of the above-mentioned hydrophobic monomeric acrylic or methacrylic acid ester of an alkyl alcohol (i.e., Monomer A described above) based on the total weight of all monomers in the copolymer; about 4 to about 9 percent by weight based on the total weight of all monomers in the copolymer of a reinforcing monomer selected from the group consisting of acrylic acid, methacrylic acid, an alkyl acrylate or methacrylate containing 1 to 3 carbon atoms in the alkyl group, acrylamide, methacrylamide, a lower alkyl-substituted acrylamide, diacetone acrylamide and N-vinyl-2-pyrrolidone; and about 15 to about 35 percent by weight (and preferably about 15 to about 25 percent by weight) of vinyl acetate based on the total weight of all monomers in the copolymer. In this embodiment the preferred acrylic or methacrylic acid ester is isooctyl acrylate and the preferred reinforcing monomer is acrylamide. [0054] The above described adhesive copolymers are known, and methods of preparation therefor are well known to those skilled in the art, having been described for example, in U.S. Pat. No. 24,906 (Ulrich), the disclosure of which is incorporated herein by reference. The polymerization reaction can be carried out using a free radical initiator such as an organic peroxide (e.g., benzoylperoxide) or an organic azo compound (e.g., 2,2′-azobis(2,4-dimethylpentanenitrile), available under the trade designation “Vazo 52” from DuPont). [0055] Since pressure-sensitive adhesives such as those described above are inherently rubbery and tacky and are suitably heat and light stable, there is no need to add tackifiers or stabilizers. However, such can be added if desired. [0056] Optionally, a pressure sensitive adhesive composition of the invention can also contain one or more skin penetration enhancers such as glyceryl monolaurate, ethyl oleate, isopropyl myristate, diisopropyl adipate and N,N-dimethyldodecylamine-N-oxide, either as a single ingredient or as a combination of two or more ingredients. The skin penetration enhancer(s) preferably form a substantially homogeneous mixture with the pressure sensitive adhesive polymer or copolymer. The total amount of skin penetration enhancer(s) present in a pressure sensitive adhesive composition of the invention is preferably about 3 percent to about 25 percent by weight, more preferably about 3 percent to about 10 percent by weight based on the total weight of the adhesive composition. [0057] When the skin penetration enhancer is a single ingredient, it is preferably a skin penetration enhancer such as isopropyl myristate, diisopropyl adipate, ethyl oleate, or glyceryl monolaurate. [0058] When a combination skin penetration enhancer is used, it is preferably a combination such as: ethyl oleate with glyceryl monolaurate; ethyl oleate with N,N-dimethyldodecylamine-N-oxide; glyceryl monolaurate with N,N-dimethyldodecylamine-N-oxide; and ethyl oleate with both glyceryl monolaurate and N,N-dimethyldodecylamine-N-oxide. [0059] A pressure-sensitive adhesive composition of the invention can be prepared by combining dry adhesive, 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine, fatty acid, and skin penetration enhancer(s) with an organic solvent. The preferred organic solvents are methanol and ethyl acetate. The total solids content of the adhesive coating is preferably in the range of about 15 percent to about 40 percent, and more preferably in the range of about 20 to about 35 percent based on the total weight of the adhesive coating. The resulting mixture is shaken or mixed for a period of about 20 to 72 hours. When this method is used it is preferred that the 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine be in micronized form (i.e., particle size of 1-2 microns in diameter). Optionally, the mixture can be heated during shaking. [0060] In a preferred method, the 1-isobutyl-1H-imidazo-4,5-c]quinolin-4-amine is combined with the fatty acid and shaken at 40° C. until there appears to be complete dissolution. The remaining ingredients are added and the mixture is shaken for a period of about 20 to 72 hours. [0061] The pressure-sensitive adhesive compositions described above are preferably coated onto one surface of a suitable backing of sheet material, such as a film, to form a pressure-sensitive adhesive coated sheet material. A pressure-sensitive adhesive coated sheet material of the invention can be prepared by knife coating a suitable release liner to a predetermined uniform thickness with a wet adhesive formulation. This adhesive coated release liner is then dried and laminated onto a backing using conventional methods. Suitable release liners include conventional release liners comprising a known sheet material, such as a polyester web, a polyethylene web, or a polystyrene web, or polyethylene-coated paper, coated with a suitable silicone-type coating such as that available under the trade designation Daubert 164Z, from Daubert Co. The backing can be occlusive, non-occlusive or a breathable film as desired. The backing can be any of the conventional materials for pressure-sensitive adhesive tapes, such as polyethylene, particularly low density polyethylene, linear low density polyethylene, high density polyethylene, randomly-oriented nylon fibers, polypropylene, ethylene-vinylacetate copolymer, polyurethane, rayon and the like. Backings that are layered, such as polyethylene-aluminum-polyethylene composites are also suitable. The backing should be substantially non-reactive with the ingredients of the adhesive coating. The presently preferred backing is low density polyethylene. [0062] The pressure-sensitive adhesive coated sheet material of the invention can be made in the form of an article such as a tape, a patch, a sheet, a dressing or any other form known to those skilled in the art. [0063] Preferably, an article in the form of a patch is made from an adhesive coated sheet material of the invention and applied to the skin of a mammal. The patch is replaced as necessary with a fresh patch to maintain the particular desired therapeutic effect of the 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine. Inherent Viscosity Measurement [0064] The inherent viscosity values reported in the Examples below were obtained by the conventional method used by those skilled in the art. The measurement of the viscosity of dilute solutions of the adhesive, when compared to controls run under the same conditions, clearly demonstrates the relative molecular weights. It is the comparative values that are significant; absolute figures are not required. In the examples, the inherent viscosity values were obtained using a Cannon-Fenske #50 viscometer to measure the flow time of 10 ml of a polymer solution (0.2 g polymer/deciliter tetrahydrofuran, in a water bath controlled at 25° C.). The examples and the controls were run under identical conditions. The test procedure followed and the apparatus used are explained in detail in the Textbook of Polymer Science, F. W. Billmeyer, Wiley-Interscience, 2nd Edition, 1971 under: Polymer chains and their characterization, D. Solution Viscosity and Molecular Size, pp 84-85, the disclosure and textbook of which is incorporated by reference. [0065] The following examples are provided to illustrate the invention, but are not intended to be limiting thereof. Parts and percentages are by weight unless otherwise specified. Examples of creams, ointments and pressure sensitive adhesive compositions contemplated by the present invention are described in U.S. Pat. No. 4,689,338 and U.S. Pat. No. 5,238,944. Percent modifications for, e.g., imiquimod and vehicle, to generate imiquimod formulations as described herein are likewise contemplated by the present invention. In addition, the formulations described and disclosed in U.S. patent application Ser. No. 11/276,324, are also contemplated by the present invention. Thus, U.S. patent application Ser. No. 11/276,324, is incorporated herein by reference in its entirety. Preparative Method 1 Laboratory Scale Preparation of Isooctylacrylate/Acrylamide Copolymer [0066] To a 114 gram narrow-mouth glass bottle were added: 18.6 g isooctyl acrylate, 1.4 g acrylamide, 0.04 g benzoyl peroxide, 27.0 g ethyl acetate and 3.0 g methanol. The solution was purged for thirty five seconds with nitrogen at a flow rate of one liter per minute. The bottle was sealed and placed in a rotating water bath at 55° C. for twenty-four hours to effect essentially complete polymerization. The polymer was diluted with ethyl acetate/methanol (90/10) to 23.2 percent solids and had a measured inherent viscosity of 1.26 dl/g in ethyl acetate. Preparative Method 2 Pilot Plant Scale Preparation of Isooctylacrylate/Acrylamide Copolymer [0067] 155 kg isooctylacrylate, 11.6 kg acrylamide, 209.1 kg ethyl acetate and 23.2 kg methanol were charged to a clean, dry reactor. Medium agitation was applied. The batch was deoxygenated with nitrogen while heating to an induction temperature of 55° C. 114 g Lucidol™70 initiator (available from Pennwalt Corp.) mixed with 2.3 kg ethyl acetate was charged to the reactor. The temperature was maintained at 55° C. throughout the reaction. After 5.5 hours reaction time, 114 g Lucidol™70 mixed with 2.3 kg ethyl acetate were charged to the reactor. After 9.0 hours reaction time, an additional 114 g Lucidol™70 initiator mixed with 2.3 kg ethyl acetate were charged to the reactor. The reaction was continued until the percent conversion was greater than 98 percent as measured by gas chromatographic evaluation of residual monomer concentration. The resulting polymer solution was diluted to 25-28 percent solids with ethyl acetate/methanol (90/10) and had a measured Brookfield viscosity of 17,000-21,000 centipoises using spindle #4 at 12 rpm. The polymer had a measured inherent viscosity of 1.3-1.4 dllg in ethyl acetate. [0068] The above procedure was found to provide a pressure-sensitive adhesive that is equivalent in the practice of the present invention to a pressure-sensitive adhesive prepared according to PREPARATIVE METHOD 1. [0069] A 25-30 percent solids solution of the isooctyl acrylate:acrylamide (93:7) adhesive copolymer in ethyl acetate/methanol (90:10) was coated onto a two-sided release liner using a knife-coater and coating at 0.5 mm in thickness. The adhesive-coated laminate was dried first at 82° C. for 3 minutes and then at 116° C. for 3 minutes. The dried adhesive coating was then stripped off the release liner and placed in a glass bottle. The foregoing procedure results in a reduction of the amount of any residual monomer in the adhesive copolymer. Preparative Method 3 Preparation of Isooctyl Acrylate: Acrylamide: Vinyl Acetate (75:5:20) Copolymer [0070] The procedure of PREPARATIVE METHOD 1 above acrylate, 8.0 g acrylamide, 32.0 g vinyl acetate, 0.32 g benzoyl peroxide, 216.0 g ethyl acetate and 24.0 g methyl alcohol. The resulting polymer was diluted with the ethyl acetate/methyl alcohol mixture to 21.52% solids. The adhesive polymer had a measured inherent viscosity of 1.40 dl/g in ethyl acetate at a concentration of 0.15 g/dl. Its Brookfield viscosity was 2,300 centipoise. Preparative Method 4 Preparation of Isooctyl Acrylate Acrylamide: Vinyl Acetate (75:5:20) Copolymer [0071] A master batch was prepared by combining 621.0 g of isooctyl acrylate, 41.4 g of acrylamide, 165.6 g of vinyl acetate, 1.656 g of 2,2′-azobis(2,4-dimethylpentanenitrile) (available from the DuPont Company as Vazo™52), 884.52 g of ethyl acetate and 87.48 g of methanol A 400 g portion of the resulting solution was placed in an amber quart bottle. The bottle was purged for two minutes with nitrogen at a flow rate of one liter per minute. The bottle was sealed and placed in a rotating water bath at 45° C. for twenty-four hours to effect essentially complete polymerization. The copolymer was diluted with 250 g of ethyl acetate/methanol (90/10) to 26.05% solids and had a measured inherent viscosity of 1.27 dl/g in ethyl acetate at a concentration of 0.15 g/dl. Its Brookfield viscosity was 5580 centipoise. Example 1 [0072] A cream according to the present invention was prepared from the following ingredients: [0000] % by Weight Amount Oil Phase 1-Isobuty1-1H-imidazo[4,5-c]- 1.0 40.0 g quinolin-4-amine Isostearic acid 10.0 400.0 g Benzyl alcohol 2.0 80.0 g Cetyl alcohol 2.2 88.0 g Stearyl alcohol 3.1 124.0 g Polysorbate 60 2.55 102.0 g Sorbitan monostearate 0.45 18.0 g Aqueous Phase Glycerin 2.0 80.0 g Methylparaben 0.2 8.0 g Propylparaben 0.02 0.8 g Purified water 76.48 3059.2 g The materials listed above were combined according to the following procedure: [0073] The glycerin, methylparaben, propylparaben and water were weighed into a 4 liter glass beaker then heated on a hot plate with stirring until the parabens isostearic acid and 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine were weighed into an 8 liter stainless steel beaker and heated on a hot plate until the amine was in solution (the temperature reached 69° C.). The benzyl alcohol, cetyl alcohol, stearyl alcohol, polysorbate 60 and sorbitan monostearate were added to the isostearic acid solution and heated on a hot plate until all material was dissolved (the temperature reached 75° C.). With both phases at approximately the same temperature (65°-75° C.), the water phase was added to the oil phase. The mixture was mixed with a homogenizer for 13 minutes then put into a cool water bath and mixed with a 3 inch propeller for 40 minutes (the temperature was 29° C.). The resulting cream was placed in glass jars. Examples 2-9 [0074] Using the general method of Example 1, the cream formulations shown in Tables 1 and 2 were prepared. [0000] TABLE 1 % by Weight 2 3 4 5 Oil Phase 1-Isobuty1-1H-imidazo- 1.0 1.0 1.0 1.0 [4,5-e]quinolin-4-amine Isostearic acid 10.0 10.0 5.0 5.0 Benzyl alcohol 2.0 — Cetyl alcohol 1.7 — Stearyl alcohol 2.3 — Cetearyl alcohol 6.0 — 6.0 6.0 Polysorbate 60 2.55 2.55 2.55 2.55 Sorbitan monostearate 0.45 0.45 0.45 0.45 Brij .TM. 30 a 10.0 Aqueous Phase Glycerin 2.0 2.0 2.0 2.0 Methylparaben 0.2 0.2 0.2 0.2 Propylparaben 0.02 0.02 0.02 0.02 Purified water 77.78 77.78 82.78 72.78 Brij .TM. 30 (polyoxyethylene(4) lauryl ether) is available from ICI Americas, Inc. indicates data missing or illegible when filed [0000] TABLE 2 % by Weight Example 6 7 8 9 Oil Phase 1-Isobuty1-1H-imidazo- 1.0 1.0 1.0 1.0 r4,5-clquinolin-4-amine Isostearic acid 10.0 25.0 10.0 6.0 Benzyl alcohol 2.0 2.0 Cetyl alcohol 2.2 1.7 Stearyl alcohol 3.1 2.3 Cetearyl alcohol 6.0 — 6.0 Polysorbate 60 2.55 3.4 2.55 2.55 Sorbitan monostearate 0.45 0.6 0.45 0.45 Brij .TM. 30 10.0 — Aqueous Phase Glycerin 2.0 2.0 2.0 2.0 Methylparaben 0.2 0.2 0.2 0.2 Propylparaben 0.02 0.02 0.02 0.02 Purified water 67.78 60.48 79.78 79.78 Example 10 [0075] A cream according to the present invention was prepared from the following ingredients: [0000] % by Weight Amount Oil Phase 1-Isobuty1-1H-imidazo[4,5-4-quinolin-4- 1.0 3.00 g amine Isostearic acid 5.0 15.0 g White petrolatum 15.0 45.0 g Light mineral oil 12.8 38.4 g Aluminum stearate 8.0 24.0 g Cetyl alcohol 4.0 12.0 g Witconol .TM. 14 a 3.0 9.00 g Acetylated lanolin 1.0 3.0 g Propylparaben 0.063 0.19 g Aqueous Phase Veegum .TM. K b 1.0 3.0 g Methylparaben 0.12 0.36 g Purified water 49.017 147.05 g Witconol .TM. 14 (polyglyceryl4 oleate) is available from Witco Chemical Corp. Organics Division b Veegum .TM. K (colloidal magnesium aluminum silicate) is available from R. T. Vanderbilt Company Inc. The materials listed above were combined according to the following procedure: [0076] The 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine and the isostearic acid were weighed into a glass jar and heated with occasional stirring until the amine was dissolved (the temperature reached 68° C.). To this solution was added, the petrolatum, mineral oil, aluminum stearate, cetyl alcohol, Witconol™14, acetylated lanoline and propylparaben. The mixture was heated to 75° C. In a separate beaker, the methylparaben and water were combined and heated until the paraben dissolved (the temperature reached 61° C.). The Veegum™K was added to the aqueous solution and heated at 75° C. for 30 minutes while mixing with a homogenizer. With both phases at 75° C., the aqueous phase was slowly added to the oil phase while mixing with a homogenizer. Mixing was continued for 30 minutes while maintaining a temperature to about 80° C. The jar was then capped and the formulation was allowed to cool. Example 11 [0077] An ointment according to the present invention was prepared from the following ingredients: [0000] % by Weight Amount 1-Isobuty1-1H-imidazo[4,5-c]quinolin-4- 1.0 0.20 g amine Isostearic acid 5.0 1.00 g Mineral oil 12.8 2.56 g White petrolatum 65.2 13.04 g  Cetyl alcohol 4.0 0.80 g Acetylated lanolin 1.0 0.20 g Witconol .TM. 143.0 0.60 g Aluminum stearate 8.0 1.60 g The materials listed above were combined according to following procedure: [0078] The 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine and the isostearic acid were placed in a glass jar and heated with stirring until the amine was dissolved. The remaining ingredients were added and the resulting mixture was heated to 65° C. and then mixed while being allowed to cool to room temperature. Example 12 [0079] Using the general procedure of Example 11 an ointment containing the following ingredients was prepared. [0000] % by Weight Amount 1-Tsobuty1-1H-imidazo[4,5-c]-quinolin-4- 1.0 0.20 g amine Isostearic acid 6.0 1.20 g Polyethylene Glycol 400 55.8 11.16 g  Polyethylene Glycol 3350 32.6 6.52 g Stearyl alcohol 4.6 0.92 g Examples 13-15 [0080] Creams of the present invention were prepared using the ingredients shown in Table 3. The Example 1 except that benzyl alcohol was used with the isostearic acid to dissolve the 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine. [0000] TABLE 3 Example 13 14 15 % by Weight Oil Phase 1-Isobuty1-1H-imidazo[4,5-4-quinolin-4- 5.0 5.0 4.85 amine Isostearic acid 25.0 25.0 24.3 Benzyl alcohol 2.0 2.0 1.94 Cetyl alcohol 2.2 2.2 1.16 Stearyl alcohol 3.1 3.1 1.75 Petrolatum 3.0 2.91 Polysorbate 60 3.4 3.4 4.13 Sorbitan monostearate 0.6 0.6 0.73 Stearic acid 9.71 Aqueous Phase Glycerin 2.0 2.0 1.94 Methylparaben 0.2 0.2 0.19 Propylparaben 0.02 0.02 0.02 Purified water 53.48 56.48 46.39 Example 16 [0081] A cream according to the present invention was prepared from the following ingredients: [0000] % by Weight Amount Oil Phase 1-Isobuty1-1H-imidazo[4,5-c]-quinolin-4- 4.0 0.80 g amine Isostearic acid 20.0 4.00 g Benzyl alcohol 2.0 0.40 g Cetyl alcohol 2.2 0.49 g Stearyl alcohol 3.1 0.62 g Polysorbate 60 3.4 0.68 g Sorbitan monostearate 0.6 0.12 g Aqueous Phase 1-Isobuty1-1H-imidazo [4,5-c]-quinolin-4- 1.0  0.2 g amine Glycerin 2.0  0.4 g 85% Lactic acid 1.0 0.22 g Methylparaben 0.2 0.04 g Propylparaben 0.02 0.004 g  Purified water 60.48 12.0 g The materials listed above were combined according to the following procedure: [0082] The isostearic acid and 0.8 g of 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine were combined in a glass jar and heated with stirring until the amine had dissolved. The remaining oil phase ingredients were added to this solution and the mixture was heated to about 70° C. The aqueous phase ingredients were weighed into a separate beaker and heated with stirring until the amine and the parabens had dissolved. With both phases at about 70° C., the water phase was added to the oil phase and mixed with a propeller until the mixture cooled to room temperature. Example 17 [0083] A mixture of 5.9415 g of the 93:7 isooctyl acrylate:acrylamide adhesive copolymer prepared in PREPARATIVE METHOD 2 above, 1.5126 g isostearic acid, 2.0075 g ethyl oleate, 0.3021 g glyceryl monolaurate, 0.2936 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine (micronized) and 23.7 g of 90:10 ethyl acetate:methanol was placed in a small glass jar. The jar was placed on a horizontal shaker and shaken at room temperature for about 13 hours. The formulation was coated at a thickness of 20 mils onto a 5 mil Daubert 164Z liner. The laminate was oven dried for 3 minutes at 105° F., for 2 minutes at 185° F., and for 2 minutes at 210° F. The resulting adhesive coating contained 59.1 percent 93:7 isooctyl acrylate:acylamide adhesive copolymer, 15.0 percent isostearic acid, 20.0 percent ethyl oleate, 3.0 percent glyceryl monolaurate and 2.9 percent 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine. The material was then laminated with 3 mil low density polyethylene backing and die cut into 2.056 cm.sup.2 patches. Examples 18-20 Pressure-Sensitive Adhesive Coated Sheet Materials Prepared Using Unmicronized 1-Isobutyl-1H-imidazo[4,5-c]quinolin-4-amine [0084] Using the general method of Example 17 the formulations shown below were prepared. 1-Isobutyl-1H-imidazo[4,5-c]quinolin-4-amine that had been ground with a mortar and pestle was used. The adhesive was the 93:7 isooctyl acrylate:acrylamide copolymer prepared in PREPARATIVE METHOD 1 above. The solvent was 90:10 ethyl acetate:methanol. All formulations were mixed at room temperature. [0000] Example 18 19 20 1-Isobuty1-1H-imidazo[4,5-0- 5.0 3.0 3.0 quinolin-4-amine Ethyl oleate 5.1 5.0 8.0 Isostearic acid 10.0 10.0 6.0 Oleic acid 20.0 20.0 13.0 Glyceryl monolaurate 1.5 1.5 1.5 N,N-dimethyldodecylamine- 1.0 1.1 3.0 N-oxide Adhesive 57.4 59.3 65.4 Example 21 [0085] A formulation with the same components in the same proportions as Example 18 was prepared using a different method. The 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine was combined with the oleic and isostearic acids and shaken at 40° C. until there was complete dissolution of the 1-isobutyl-1H-imidazo-[4,5-c]quinolin-4-amine. The remaining ingredients were added and shaken a 40° C. for 72 hours. Patches measuring 2.056 cm.sup.2 were prepared by the general method of Example 17. Example 22 [0086] A mixture of 2.4734 g 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine 3.3315 g isostearic acid and 6.6763 g oleic acid was prepared. To 1.8738 g of the above mixture was added 2.8750 g of the 93:7 isooctyl acrylate:acryamide adhesive copolymer prepared in PREPARATIVE METHOD 2 above, 0.2548 g of ethyl oleate, 0.0510 g N,N-dimethyl-dodecylamine-N-oxide, 0.0820 g glyceryl monolaurate (from Lauricidin, Inc.) and 14.0457 g of 90:10 ethyl acetate/methanol. The above was shaken for 30 hours at room temperature on a horizontal shaker. Transdermal patches were then prepared generally according to the procedures of Example 17.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 13/937,102 tiled Jul. 8, 2013, which application is a continuation of U.S. application Ser. No. 13/354,210, tiled Jan. 19, 2012, now U.S. Pat. No. 8,480,648; which application is a continuation of U.S. application Ser. No. 12/098,365, filed Apr. 4, 2008, now U.S. Pat. No. 8,100,880; which application claims the benefit of U.S. Provisional Patent Application No. 60/921,974, filed Apr. 5, 2007 to Burnett, entitled “Safety Access Device, Fluid Output Monitor & Peritoneal Organ Preservation”, all disclosures of which are incorporated by reference herein in their entirety. INCORPORATION BY REFERENCE [0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. BACKGROUND OF THE INVENTION [0003] Fluids and other substances are infused into patients for a variety of reasons. For example, fluids may be given to a patient intravenously to hydrate the patient or to control overall blood volume. [0004] It is often important to control infusion of fluid into patients in order to optimize the therapy being provided. Monitoring of patient parameters can consume precious health care time and resources, however. Fluid infusion into patients is therefore not always optimized. [0005] Mantle US 2006/0161107 describes a system that extracts fluid from a body cavity, processes the fluid and then recirculates fluid back into the cavity. Mantle does not describe infusion of a fluid into a patient without extraction of the fluid from the patient, however. In addition, the parameters on which the Mantle system is controlled are limited. SUMMARY OF THE INVENTION [0006] One aspect of the invention provides an automated therapy system having an infusion catheter; a sensor adapted to sense a patient parameter; and a controller communicating with the sensor and programmed to control flow output from the infusion catheter into a patient based on the patient parameter without removing fluid from the patient. In some embodiments, the sensor may be incorporated into the catheter, and in other embodiments, the sensor may be separate from the catheter. The sensor may be, e.g., an ECG sensor; an EEG sensor; a pulse oximetry sensor; a blood pressure sensor; a cardiac output sensor; a thermodilution cardiac output sensor; a cardiac stroke volume sensor; a heart rate sensor; a blood flow sensor; a pH sensor; a blood pO 2 sensor; an intracranial pressure sensor; and/or a solute sensor. [0007] In embodiments of the invention, the catheter may be a peripheral venous catheter; a central venous catheter; an arterial catheter; or a peritoneal catheter (possibly incorporating an intraperitoneal pressure sensor). [0008] Another aspect of the invention provides a method of controlling infusion of a fluid to a patient. The method includes the following steps: monitoring a patient parameter with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient. In some embodiments, the method includes the step of monitoring cardiac output with the sensor and, possibly, adjusting fluid flow to the patient based on cardiac output monitored by the sensor. In embodiments of the invention, the patient parameter includes an electrocardiogram; an electroencephalogram; blood oxygen saturation; blood pressure; cardiac output; cardiac stroke volume; heart rate; blood flow; total circulating blood volume; whole body oxygen consumption; pH; blood pO 2 ; osmolarity; peritoneal cavity compliance; intrathoracic pressure; bladder pressure; and/or rectal pressure. [0009] In some embodiments, the adjusting step includes the step of adjusting fluid flow to achieve or maintain patient euvolumia; adjusting flow of a therapeutic agent (such as a chilled medium) to the patient; adjusting fluid flow to the patient through a peripheral venous catheter; adjusting fluid flow to the patient through a central venous catheter; adjusting fluid flow to the patient through an arterial catheter; and/or adjusting fluid flow to the patient's peritoneal cavity. [0010] Yet another aspect of the invention provides a method of treating hypotension in a patient. The method includes the following steps: monitoring a patient parameter (such as blood pressure or cardiac output) with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient. [0011] Still another aspect of the invention provides a method of treating sepsis in a patient. The method includes the following steps: monitoring a patient parameter (such as blood pressure, central venous pressure, or cardiac output) with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient. Prevention of hypotension and/or hypovolemia is critical in the care of patients that have suffered severe hemorrhage or are septic. These patients are very difficult to monitor and treat, taking significant nursing time and still resulting in suboptimal therapy due to the intermittent nature of the blood pressure, central venous pressure and/or cardiac output checks. The present invention, then, will optimize fluid flow to the patient while also freeing up the already over-taxed nursing staff for other duties. [0012] Yet another aspect of the invention provides a method of inducing and reversing therapeutic hypothermia in a patient. The method includes the steps of: monitoring intracranial pressure to generate a sensor signal; providing the sensor signal to a controller; and adjusting rate of hypothermia induction or rewarming based on intracranial pressure such as by adjusting fluid flow to the patient), or depth of hypothermia, based on the sensor signal. [0013] In some embodiments of the invention, irrigation and/or lavage of bodily tissues, cavities or spaces (or other patient interventions) may be optimized using a sensor or sensors to report electrical, chemical, acoustic, mechanical properties, pressure, temperature, pH or other parameters surrounding the access device in order to automate and optimize the irrigation/lavage. [0014] Embodiments of the invention include a peritoneal catheter containing one or more sensors which may detect changes in electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), peritoneal cavity compliance, intrathoracic pressure, intraperitoneal pressure, intraperitoneal pressure waveforms, bladder pressure, rectal pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (e.g., in superior mesenteric, celiac, renal or other arteries), pressure in veins (particularly the inferior vena cava or those that empty into the inferior vena cava, e.g., femoral vein), pressure in arteries (particularly those distal to the aorta, e.g., the femoral artery), total circulating blood volume, blood oxygenation (e.g., in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and/or arterial pO 2 (or any other parameter that shows a measurable change with increased peritoneal pressure) to ensure safety of automated or manual peritoneal lavage. The invention also includes methods of performing peritoneal lavage using such devices. [0015] Embodiments of the invention include an intravascular catheter containing one or more sensors which may detect changes in electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), partial pressure of oxygen or CO 2 , pH, temperature, blood pressure, central venous pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (e.g., in superior mesenteric, celiac, renal or other arteries), total circulating blood volume, pressure in veins (particularly those that empty into the inferior vena cava, e.g., femoral vein), pressure in arteries (particularly those distal to the aorta, e.g., the femoral artery), blood oxygenation (e.g., in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and/or arterial pO 2 (or any other parameter that shows a measurable change with intravascular volume overload) to ensure safety of manual or automated intravascular infusion. The invention also includes methods of using such devices. [0016] Other embodiments of the invention include control of the rate of infusion to minimize negative effects observed by the sensors. The invention may be used to induce and/or maintain hypothermia or hyperthermia; maximize hydration and/or intravascular volume in a patient receiving intravenous fluids (such as, e.g., post-operative patients, post-hemorrhage patients, septic patients or other intensive care patients). BRIEF DESCRIPTION OF THE DRAWINGS [0017] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the Wowing detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [0018] FIG. 1 shows an automated infusion system in which infusion is controlled based on patient parameters sensed by multiple sensors. [0019] FIG. 2 shows an automated infusion system in which a sensor controlling infusion is separate from the infusion catheter. [0020] FIG. 3 shows an automated infusion system in which sensing and infusion are performed with the same catheter. DETAILED DESCRIPTION OF THE INVENTION [0021] FIGS. 1-3 show embodiments of the invention wherein intravenous fluid delivery may be automated, or manually adjusted, based on feedback from one or more sensors. In these embodiments, the infusion catheter may have a sensor to aid in insertion, but this is not necessary for this invention. [0022] In one embodiment, the infusion catheter also is used to detect the parameters used to optimize therapy. FIG. 1 shows an infusion system with an infusion controller 10 operably connected to an intravenous infusion catheter 12 via an infusion line 14 . Infusion catheter 12 also has a sensor (not shown) attached to or associated with it to monitor a patient parameter. The sensor also communicates with controller 10 either through line 14 or via some other communication channel. Suitable patient parameters include electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), blood pressure, central venous pressure, cardiac output, cardiac stroke volume, cardiac rate, blood flow (e.g., in superior mesenteric, celiac, renal or other arteries), total circulating blood volume, pressure in veins (particularly those that empty into the inferior vena cava, e.g., femoral vein), pressure in arteries (particularly those distal to the aorta, e.g., the femoral artery), blood oxygenation (e.g., in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH, arterial pO 2 , or any other parameter that shows a measurable change with intravascular volume overload. [0023] As shown in FIG. 1 , additional catheters, here envisioned as a peripherally inserted central catheter (PICC) 16 and/or a peritoneal catheter 18 , or additional sensors on infusion catheter 12 may be used to monitor these or other parameters, and to optimize the infusion rate and achieve euvolemia without fluid overload or dehydration. Flow of fluid and or a fluid solid mixture (e.g., an ice slurry) to catheters 16 and/or 18 is controlled by controller 10 through lines 14 , 15 and/or 17 , respectively. The information from the sensors may then be transmitted to central controller 10 , which integrates all of this information to determine the flow of intravenous fluid through catheter 12 and/or catheter 16 and flow of peritoneal fluid through catheter 18 . This information may be used to achieve or maintain euvolemia (e.g., in sepsis, hemorrhagic shock, etc.) or to maximize infusion for delivery of a therapeutic agent, e.g., chilled fluid and/or solids to achieve hypothermia. Alternatively, catheters 16 and 18 may be used with sensors to obtain patent information, and fluid may be infused into the patient solely through catheter 16 or catheter 18 . In yet further embodiments, the depth of hypothermia and/or rate of hypothermia induction or rewarming may be tailored based on intracranial pressure sensor(s) (not shown) communicating with controller 10 via communication line 35 . This system and method may be used with any method of inducing hypothermia (e.g., cooling blankets, intravascular catheters, intravenous fluid infusion, peritoneal lavage, etc.) so long as the change in temperature, particularly rewarming, is controlled at least in part by an intracranial pressure sensor. [0024] The sensor or sensors, whether cables/catheters or percutaneous monitoring technologies, and whether wired or wireless, may also be separate from the infusion line so long as the information from this sensor or sensors is transferred to the control unit in order to optimize fluid flow. Thus, as shown in FIG. 2 , the patient parameter sensor may be associated with PICC 24 and communicate with controller via line 26 , and infusion to the patient may be via line 22 and infusion catheter 20 , as controlled by controller 10 . In some embodiments, of course, sensing and infusion may be performed through a single catheter, such as PICC 30 , and controlled by controller 10 through lines 32 and 34 , as shown in FIG. 3 . In some embodiments, the infusion and monitoring device of the current invention may incorporate an access sensor, such as that described in a commonly owned patent application, U.S. patent application Ser. No. 12/098,355, filed Apr. 4, 2008, titled “Device And Method For Safe Access To A Body Cavity”. [0025] One example of such a device is a peripheral venous, central venous or arterial catheter that is capable of maintaining hydration without causing fluid overload. The catheter may incorporate a sensor that may detect central venous pressure, total circulating blood volume, peripheral venous pressure, cardiac output or osmolarity, and/or solute concentrations e.g., chloride, sodium, etc.) in order to prevent fluid overload. The sensor may also be external to catheter, so long as the output of said sensor is capable of controlling fluid flow through the catheter. In this embodiment, fluid flow is controlled by the output of the sensor, which is integrated by a fluid flow control unit which alters the rate of fluid flow based on this output. This embodiment may allow the user to bolus large volumes of fluids or solids into the vascular space in order to rehydrate, induce hypothermia or reverse hypothermia, or deliver a therapeutic agent or maintain blood pressure in sepsis. [0026] In addition, this technology may provide a fully automated mechanism to optimize fluid flow into the vessel without fluid overloading the patient. Without this automated fluid delivery coupled to hemodynamic parameter monitoring, the patient is in danger of dehydration or fluid overload from infusion of fluid into any body cavity. This technology may also be applied to liquid or solid infusion into any body cavity or space in so long as the fluid flow is automated based on feedback from sensors within the body (possibly incorporated into the catheter itself) in order to optimize the volume of infusion. [0027] This device and method of automating fluid flow based on hemodynamic sensor-based feedback may also be used to generate intravenous hypothermia. In its current state, IV hypothermia induction is limited due to concerns of fluid overload. If the hemodynamic parameters of the patient can be measured and fluid flow directly or indirectly controlled based on the output of these measurements, the volume of fluid can be maximized while ensuring hemodynamic instability. In this embodiment, the sensor may be incorporated within the catheter, and fluid flow into the vasculature may be tailored based on central venous pressure, total circulating blood volume, peripheral venous pressure, cardiac output or osmolarity, and/or solute concentrations (e.g., chloride, sodium, etc.) in order to prevent fluid overload. [0028] In one embodiment, the fluid infusion catheter also may function as a thermodilution cardiac output sensor such that the same fluid that is used to generate hypothermia may also be used to detect cardiac output. This information may then be relayed, either directly or indirectly, back to the fluid infusion controller to increase, decrease or even halt fluid flow based on these parameters. For example, if cardiac output is low and venous pressure or total circulating volume is low, the patient has a low circulating volume and large volumes of fluid may be safely delivered. If the cardiac output is normal, fluid may also be safely delivered, but the cardiac output must be monitored to ensure that it does not begin to decrease (an indication of fluid overload). Blood flow, as detected by, for instance, thermodilution may be determined in a peripheral vessel as well. These data, while relatively useless on their own in a clinical setting due to variability in peripheral blood flow, may provide a baseline flow profile which may be rechecked over time in order to compare flow within that individual vessel to the baseline flow. Relatively improved flow may be correlated to improved cardiac output, while a relative reduction in flow may be correlated to fluid overload. [0029] This same system may be used to infuse normal fluids or hypothermic fluids to sepsis patients or patients requiring intensive maintenance of their hemodynamic status. Sepsis patients that are aggressively monitored do much better than those that are not. Aggressive monitoring is very nurse-intensive, however. A system that provides automated optimal fluid infusion based on sensed parameters to ensure that fluid overload does not occur and that fluid infusion is not insufficient would be an improvement over current methods of treating sepsis patients. The devices and methods for automated sensor-based input to control fluid flow to a patient may be applicable to a wide range of conditions and should not be limited to the narrow scope of the conditions requiring fluid infusion described here. [0030] The logic controller of the present invention may provide improved safety by monitoring for any of the deleterious changes expected with excess fluid flow, e.g., into the peritoneal cavity or vascular space. Examples of monitored parameters that may signal a warning or automatically result in an adjustment to rate of fluid infusion/extraction and/or fluid temperature include: electrocardiograph monitoring, electroencephalograph monitoring, pulse oximetry (either internally or peripherally), peritoneal cavity compliance, intrathoracic pressure, intraperitoneal pressure, intraperitoneal pressure waveforms, bladder pressure, rectal pressure, cardiac output, cardiac stroke volume, cardiac rate, total circulating blood volume, blood flow (e.g., in superior mesenteric, celiac, renal or other arteries), pressure in veins (particularly those that empty into the IVC, e.g., femoral vein), pressure in arteries (particularly those distal to the aorta, e.g., the femoral artery), blood oxygenation (e.g., in rectal mucosa, peripheral fingers and toes, etc.), whole body oxygen consumption, pH and arterial pO 2 and any other parameter that shows a measurable change once the peritoneal or vascular spaces have been overloaded. [0031] These parameters in particular have been found to change with increases in peritoneal pressure, with significantly negative impact on each parameter found at 40 mmHg. Thus, monitoring for these changes in conjunction with a peritoneal infusion catheter of the present invention will allow for even greater safety with peritoneal infusion. These parameters may be measured a variety of ways and the data transmitted either wirelessly or via wires to the logic controller in order to alert the healthcare provider or to automatically adjust the fluid flow/temperature in order to optimize both the flow of the peritoneal fluid and patient safety.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application 61/231,084, filed on Aug. 4, 2009, and incorporated herein by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT Not Applicable. FIELD OF THE INVENTION This invention relates to the eradication of pathogens, and more particularly to a recharging and disinfecting docking station for portable electronic products. DISCUSSION OF RELATED ART Medical environments, such as hospitals and doctors' offices, are known to contain a relatively high concentration of pathogens. As a result, it is desirable to reduce such pathogens wherever they exist in such environments. As a doctor makes his rounds from patient to patient in a hospital, for example, the objects the doctor carries are susceptible to contamination throughout the day. One such object a doctor may routinely carry is a medical tablet computer, which a doctor may use to make notes on a patient file, write prescriptions, and the like. Such portable electronic devices frequently need to be recharged, yet currently there is no provision in recharging stations for such devices for disinfecting such devices. Therefore, there is a need for a device that not only charges portable electronic devices, but that also concurrently disinfects such devices. Such a needed device would allow for the charging of multiple portable electronic devices, and would ensure disinfecting wavelengths of light reach substantially every surface of each portable electronic device therein. The present invention accomplishes these objectives. SUMMARY OF THE INVENTION The present device is a disinfecting docking station for at least one portable electronic device, such as a medical technician's tablet computer, that has at least one recharging connector. A substantially opaque enclosure is adapted to receive the at least one portable electronic device therein through at least one openable side. The enclosure further includes at least one door for selectively sealing the openable side. The enclosure may include reflective inner surfaces therein for reflecting disinfecting wavelengths of light. A recharging means for recharging each of the at least one portable electronic device through the recharging connector thereof is adapted to transmit disinfecting wavelengths of light to the at least one portable electronic device. The recharging means preferably includes a backplane connector for electrically communicating with the recharging connector of the at least one portable electronic device. The back plane connector is connected with a power source and is preferably at least partially transparent to the disinfecting wavelengths of light and capable of transmitting such light to substantially all of the surfaces of the recharging connector. At least one means of supporting each of the at least one portable electronic device is included, each means of supporting adapted to transmit the disinfecting wavelengths of light to the at least one portable electronic device. Preferably each means of supporting each include at least one shelf surface, each of which is substantially transparent to the disinfecting wavelengths of light. Each shelf surface may be comprised of a relatively small surface area where actually contacting the portable electronic device. At least one disinfecting means, each adapted for producing the disinfecting wavelengths of light only when the door is in a closed position, is included. A control circuit may be further included and electrically connected with the power source, a user interface disposed on an outside surface of the enclosure, a switch for detecting when the door is in the closed position, and the ultraviolet light source. Such a control circuit includes a timer for activating the ultraviolet light source only when the switch indicates that the door is in the closed position and only for a predetermined period of time once activated by the user interface. In use, with at least one of the portable electronic devices supported by the means of supporting within the enclosure and the door in the closed position, the means for disinfecting may be activated to produce the disinfecting wavelengths of light, illuminating substantially each surface of each of the portable electronic devices for a predetermined period of time. The present invention is a device that charges and concurrently disinfects portable electronic devices. The present device allows for the charging of multiple portable electronic devices, and ensures disinfecting wavelengths of light reach substantially every surface of each portable electronic device therein. Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the invention, illustrate a stack of docking stations of the invention with daisy-chain power and network connectors; FIG. 2 is a top view of a recharging means thereof; FIG. 3 is a diagram of various components of a control circuit of the invention; FIG. 4 is a front diagram of one embodiment of the invention wherein ultraviolet light sources of the invention are oriented in a coplanar configuration with a plurality of portable electronic devices stored within an enclosure of the invention; FIG. 5 is a top view of an alternate means for recharging each portable electronic device; FIG. 6 is a side view of an alternate embodiment of the invention, wherein the ultraviolet light sources of the invention are oriented substantially perpendicular to the plurality of portable electronic devices stored within the enclosure; FIG. 7 is a partial top view of the invention; and FIG. 8 is a partially cut-away side elevational view of an alternate embodiment of the invention in a closed position; and FIG. 9 is a partially cut-away side elevational view of the embodiment of FIG. 8 in an open position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Illustrative embodiments of the invention are described below. The following explanation provides specific details for a thorough understanding of and enabling description for these embodiments. One skilled in the art will understand that the invention may be practiced without such details. In other instances, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments. 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.” Words using the singular or plural number also include the plural or singular number respectively. Additionally, the words “herein,” “above,” “below” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. When the claims use the word “or” in reference to a list of two or more items, that word covers all of the following interpretations of the word: any of the items in the list, all of the items in the list and any combination of the items in the list. FIGS. 1 and 2 illustrate a disinfecting docking station 10 for at least one portable electronic device 20 , such as a medical technician's tablet computer, that has at least one recharging connector 22 and may include various crevices 26 therein for air ducting ports, alternate connectors, door or compartment actuators, or the like. While the illustrations herein show the invention as used with tablet computers, any portable electronic device may be used, such as portable phones, music players, electronic book readers, or other electronic devices used in environments where reduction of pathogens is desirable. A substantially opaque enclosure 30 is adapted to receive the at least one portable electronic device 20 therein through at least one openable side 35 . The enclosure 30 further includes at least one door 40 for selectively sealing the openable side 35 between a closed position 41 and an open position 42 ( FIG. 1 ). The door 40 is preferably connected with the enclosure 30 through a suitable hinge arrangement. The enclosure 30 may include reflective inner surfaces 90 therein for reflecting disinfecting wavelengths of light 65 about the enclosure 30 . The enclosure 30 is made of any suitably rigid, strong, opaque material, such as metal, plastic, or the like. A recharging means 50 for recharging each of the at least one portable electronic device 20 through the recharging connector 22 thereof is adapted in one embodiment to transmit disinfecting wavelengths of light 65 to the at least one portable electronic device 20 . The recharging means 50 preferably includes a backplane connector 52 for electrically communicating with the recharging connector 22 of the at least one portable electronic device. The back plane connector 52 is connected with a power source 80 and is preferably at least partially transparent to the disinfecting wavelengths of light 65 and capable of transmitting such light 65 to substantially all of the surfaces of the recharging connector 22 . In one embodiment, the backplane connector 52 includes a plurality of elongated, relatively thin electrical pins 150 ( FIG. 2 ), around which the disinfecting wavelengths of light 65 may travel so as to fully expose the recharging connector 22 . The backplane connector 52 may be included at a rear side of the enclosure 30 , as illustrated, or elsewhere within the enclosure 30 as necessary based on the type of portable electronic devices used therewith and the location of its recharging connector 22 . At least one means of supporting 70 each of the at least one portable electronic device 20 is included, each means of supporting 70 adapted to transmit the disinfecting wavelengths of light 65 to the at least one portable electronic device 20 . Preferably each means of supporting 70 includes at least one shelf surface 72 , each of which is substantially transparent to the disinfecting wavelengths of light 65 . In one embodiment, each means of supporting 70 includes at least one reflective surface 90 for reflecting a portion of the disinfecting wavelengths of light 65 into a crevice 26 of one of the at least one portable electronic device 20 , as determined by the particular portable electronic device 20 used with the docking station 10 . Such a crevice 26 may be, for example, an inset connector, a stylus or pen cavity, an inset screw access aperture, or the like. Each shelf surface 72 may be comprised of a relatively small surface area where actually contacting the portable electronic device 20 , and may include small prongs, rollers (not shown) or other means having a small contact area with the electronic device 20 . As such, 99% or greater of the surface 25 of each portable electronic device 20 may be exposed to the disinfecting wavelengths of light 65 . Alternately, each means of supporting 70 may be opaque and include support pins (not shown) that alternately extend and retract, such that, where alternately supported, each portable electronic device 20 is exposed to the disinfecting wavelengths of light 65 in an alternating fashion. At least one disinfecting means 60 , each adapted for producing the disinfecting wavelengths of light 65 only when the door is in the closed position 42 , is included. Preferably each disinfecting means 60 includes an ultraviolet light source 62 , such as an ultraviolet light bulb. The enclosure 30 may further include a plurality of ultraviolet light filters 180 ( FIG. 7 ) fixed within the enclosure 30 to block at least some of the ultraviolet light 65 from sensitive areas 29 of the portable electronic device 20 , such as photocells or camera elements thereof, for example. A control circuit 100 ( FIGS. 1 & 3 ) may be further included and electrically connected with the power source 80 , a user interface 110 disposed on an outside surface 38 of the enclosure 30 , a switch 120 for detecting when the door 40 is in the closed position, and the ultraviolet light source 62 . Such a control circuit 100 includes a timer 130 for activating the ultraviolet light source 62 only when the switch 120 indicates that the door 40 is in the closed position and only for a predetermined period of time once activated by the user interface 110 . The user interface 110 and control circuit 100 may provide options for delivering varying durations or intensities of the disinfecting wavelengths of light 65 , based on selections made at the user interface 110 . For example, overnight disinfection of each portable electronic device 20 may include longer durations or stronger intensities of the disinfecting wavelengths of light 65 than disinfection between patient encounters. Further, the control circuit 100 may include provisions for illuminating a portion of the total number of ultraviolet light sources 62 within the enclosure 30 , based on the number of portable electronic devices 20 contained therein. In use, with at least one of the portable electronic devices 20 supported by the means of supporting 70 within the enclosure 30 and the door 40 in the closed position 41 , the means for disinfecting 60 may be activated to produce the disinfecting wavelengths of light 65 , illuminating substantially each surface 25 of each of the portable electronic devices for a predetermined period of time. In one embodiment of the invention, each means for recharging 50 may be a retractable connector (not shown), such that after the predetermined period of time has elapsed and the means for disinfecting 60 has been deactivated by the control circuit 100 , such a retractable connector may extend to engage the recharging connector 22 of the portable electronic device 20 , the recharging connector 22 having been thoroughly disinfected by the disinfecting wavelengths of light 65 while previously disengaged from the means for recharging 50 . In such an embodiment, the backplane connector 52 includes a motorized arrangement (not shown) for engaging the recharging connector 22 , the motorized arrangement controlled by the control circuit 100 . It is understood that the term “recharging connector” used herein may also refer to other types of connectors, such as network connectors, interface connectors, VGA connectors, and the like. The control circuit 100 may allow for varying exposure time and intensity of the disinfecting wavelengths of light 65 depending on selections made at the user interface 110 . For example, a “double” disinfecting dose of the disinfecting wavelengths of light 65 may be selected on the user interface 110 , which may double the exposure time of each portable electronic device 20 to the disinfecting wavelengths of light 65 , for example. Further, in the case where the enclosure 30 holds a plurality of the portable electronic devices 20 , any particular device 20 may be selected for exposure to the disinfecting wavelengths of light 65 at the user interface 110 . For example, “bay 3 ” (not shown) may be selected, whereupon the control circuit only activates the ultraviolet light sources 62 associated with that particular location within the enclosure 30 . A suitable embodiment for such functionality is illustrated in FIG. 4 . In one embodiment, the control circuit 100 is further connected to at least one photocell 190 sensitive to ultraviolet light, such that the control circuit 100 may activate the ultraviolet light source 62 only for a duration sufficient to provide a predetermined dose, or number of lumens, for example, to each portable electronic device 20 , as determined by the at least one photocell 190 and the control circuit 100 ( FIG. 3 ). In one embodiment, each door 40 includes the means of supporting 70 and is pivotally attached with the enclosure 30 at a lower end 43 thereof ( FIGS. 8 and 9 ). In such an embodiment, the enclosure 30 may be adapted to hold only a single portable electronic device 20 , or the enclosure 30 may be equipped with a plurality of such doors 40 to hold a plurality of single portable electronic devices 20 . Preferably the power source 80 of the enclosure 30 includes a daisy chain connector 170 fixed with the enclosure 30 such that a plurality of enclosures 30 can be stacked ( FIGS. 1 and 6 ), each enclosure 30 connecting with the daisy chain connector 170 of its next adjacent enclosure 30 . As such, a single power source 80 may be included and connected to each enclosure 30 in stack of such enclosures 30 through each enclosure's daisy chain connector 170 . It is understood that the power source may be an A/C line voltage source, or a low-voltage D/C source. In a similar manner, each enclosure 30 may further include a network switch means 200 for providing network connectivity to each of the portable electronic device 20 stored therein. A network daisy chain connector 171 may be included for electrically connecting each network switch means 200 of each enclosure 30 in a stack of such enclosures 30 , whereby only one network connection is required for the stack of enclosures 30 . For portable electronic devices 20 that include wireless network capability, such as through WiFi or the like, a radio frequency refractor (not shown) may be included within the enclosure 30 so as to allow such wireless radio signals to pass substantially unimpeded through the enclosure 30 . While a particular form of the invention has been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention. For example, the particular shape of the enclosure 30 , and the number of portable electronic devices 20 illustrated in the drawings, may be altered considerably as desired. Accordingly, it is not intended that the invention be limited, except as by the appended claims. The teachings provided herein can be applied to other systems, not necessarily the system described herein. The elements and acts of the various embodiments described above can be combined to provide further embodiments. All of the above patents and applications and other references, including any that may be listed in accompanying filing papers, are incorporated herein by reference. Aspects of the invention can be modified, if necessary, to employ the systems, functions, and concepts of the various references described above to provide yet further embodiments of the invention. These and other changes can be made to the invention in light of the above Detailed Description. While the above description details certain embodiments of the invention and describes the best mode contemplated, no matter how detailed the above appears in text, the invention can be practiced in many ways. Details of the system may vary considerably in its implementation details, while still being encompassed by the invention disclosed herein. Particular terminology used when describing certain features or aspects of the invention should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the invention with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the invention to the specific embodiments disclosed in the specification, unless the above Detailed Description section explicitly defines such terms. Accordingly, the actual scope of the invention encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the invention. The above detailed description of the embodiments of the invention is not intended to be exhaustive or to limit the invention to the precise form disclosed above or to the particular field of usage mentioned in this disclosure. While specific embodiments of, and examples for, the invention are described above for illustrative purposes, various equivalent modifications are possible within the scope of the invention, as those skilled in the relevant art will recognize. Also, the teachings of the invention provided herein can be applied to other systems, not necessarily the system described above. The elements and acts of the various embodiments described above can be combined to provide further embodiments. All of the above patents and applications and other references, including any that may be listed in accompanying filing papers, are incorporated herein by reference. Aspects of the invention can be modified, if necessary, to employ the systems, functions, and concepts of the various references described above to provide yet further embodiments of the invention. Changes can be made to the invention in light of the above “Detailed Description.” While the above description details certain embodiments of the invention and describes the best mode contemplated, no matter how detailed the above appears in text, the invention can be practiced in many ways. Therefore, implementation details may vary considerably while still being encompassed by the invention disclosed herein. As noted above, particular terminology used when describing certain features or aspects of the invention should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the invention with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the invention to the specific embodiments disclosed in the specification, unless the above Detailed Description section explicitly defines such terms. Accordingly, the actual scope of the invention encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the invention under the claims. While certain aspects of the invention are presented below in certain claim forms, the inventor contemplates the various aspects of the invention in any number of claim forms. Accordingly, the inventor reserves the right to add additional claims after filing the application to pursue such additional claim forms for other aspects of the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation in part (CIP) of U.S. patent application Ser. No. 10/485,731, which is the U.S. National Phase Application under 35 U.S.C. 371 of PCT International Application No. PCT/IL02/00615, which has an international filing date of Jul. 25, 2002, and which claims priority from Israel Patent Application No. 144,749, filed Aug. 6, 2001, each of which is expressly incorporated herein in its entirety by reference thereto. FIELD OF THE INVENTION The present invention relates to the field of food/drink containers and multimedia systems. More specifically, the present invention relates to a combination of a food/drink container with a multimedia system. BACKGROUND OF THE INVENTION Entertainment methods are widely used for promoting sales of products, especially to promote children food packages. These entertainment methods include adding toys and games to some products, getting the user to participate the user in collecting-games or lottery-games and many other methods. The present invention provides the user an immediate entertainment source while he consumes the product. The present invention provides a container with a combination of a multimedia module with a product, this multimedia module designed to be operate while the content of the container is consumed. SUMMARY OF THE INVENTION The present invention relates to food/drink containers. More specifically, the present invention relates to food/drink containers combined with audio and video capabilities for inducing eating habits as well as for recreational purposes. Hereinafter the term “multimedia” shall include any sound, audio, video, music and the like. Hereinafter the term “multimedia module” shall include any multimedia system and/or equipment capable of producing sound, audio, video, music and the like. Hereinafter the term “fuel reservoir” shall include but will not be limited to a natural or artificial source, storage or collection of fuel and/or energy, a receptacle or chamber for holding a fuel and/or energy sources or a large or extra supply, reserve or stock of a source of energy. According to the teachings of the present invention there is provided, a food/drink container comprising: (a) a closure for closing the container, and (b) a multimedia module responsive to opening the container, the multimedia module including: a speaker, and a projecting unit for projecting an image or a movie viewable from the outside the container. According to further embodiments of the present invention the food/drink container further includes a personal viewer for readily facilitating viewing the image or movie by a single user. According to further embodiments of the present invention the food/drink container further including an IR port for receiving commands from a wireless remote control. According yet further embodiments of the present invention the food/drink container farther including a screen for displaying the image or movie. According to still further embodiments of the present invention the food/drink container further including a cellular module, the cellular module including: (a) a microphone for readily facilitating two-way conversation utilizing the cellular module, and (b) an earphone for readily facilitating two-way conversation utilizing the cellular module. According to further embodiments of the present invention, the container further including a sensor responsive to the closure being partially or totally opened. According to further teachings of the present invention there is provided, a food/drink container including: (a) a closure for closing the container, and (b) a radio responsive to opening the container, the radio including a speaker for facilitating output of sound. According to further embodiments of the present invention, the food/drink container further including an earphone jack for readily accommodating an earphone plug, thereby readily facilitating a user to use earphones with the radio. According to still further embodiments of the present invention, the food/drink container further including an IR port for receiving commands from a wireless remote control. According to yet further embodiments of the present invention, the food/drink container further including a cellular module, the cellular module including: (a) a microphone for readily facilitating two-way conversation utilizing the cellular module, and (b) an earphone for readily facilitating two-way conversation utilizing the cellular module. According to further embodiments of the present invention, the food/drink container further including a sensor responsive to the closure being partially or totally opened. According to yet further embodiments of the present invention, the sensor is a sensor sensitive to light such that the sensor is responsive to light entering the container subsequently to the closure being partially or totally removed. According to further embodiments of the present invention, the food/drink container further including an electrical circuit connected to a power source, such that the power source provides power to a sensor responsive to the closure being opened. According to further teachings of the present invention there is provided, a food/drink container including: (a) a semi flexible floor (b) a closure for closing the container, (c) a multimedia module responsive to opening the container, the multimedia module including: (i) a speaker, and (ii) a projecting unit for projecting an image viewable from the outside the container, and (d) a switch responsive to a spoon being entered into the container and displacing the semi flexible floor, such that the switch activates the multimedia module. According to further embodiments of the present invention, the food/drink container further including a personal viewer for readily facilitating viewing the image or movie by a single user. According to still further embodiments of the present invention, the food/drink container further including an IR port for receiving commands from a wireless remote control. According to yet farther embodiments of the present invention, the food/drink container further including a screen for displaying the image or movie. According to further embodiments of the present invention, the food/drink container further includes a cellular module, the cellular module including: (a) a microphone for readily facilitating two-way conversation utilizing the cellular module, and (b) an earphone for readily facilitating two-way conversation utilizing the cellular module. According to still further teachings of the present invention there is provided, a food/drink container including: (a) a semi flexible floor, (b) a closure for closing the container, (b) a radio responsive to opening the container, the radio including a speaker for facilitating output of sound, and (c) a switch responsive to a spoon being entered into the container and displacing the semi flexible floor, such that the switch activates the radio. According to further embodiments of the present invention, the food/drink container further including an earphone jack for readily accommodating an earphone plug, thereby readily facilitating a user to use earphones with the radio. According to still further embodiments of the present invention, the food/drink container further includes an IR port for receiving commands from a wireless remote control. According to yet further embodiments of the present invention, the food/drink container further including a cellular module, the cellular module including: (a) a microphone for readily facilitating two-way conversation utilizing the cellular module, and (b) an earphone for readily facilitating two-way conversation utilizing the cellular module. According to further embodiments of the present invention, the food/drink container further including an electrical circuit connected to a power source, such that the power source provides power to the switch and the cellular module. According to yet further teachings of the present invention there is provided, a food/drink container including: (a) a closure for closing the container, and (b) an audio device for playing music, which audio device is responsive to opening the container, the audio device module including a speaker. According to further embodiments of the present invention, the food/drink container further including an earphone for readily facilitating listening to the audio device. According to still further embodiments of the present invention, the food/drink container further including a sensor responsive to the closure being partially or totally opened. According to yet further embodiments of the present invention, the food/drink container further including an IR port for receiving commands from a wireless remote control. According to further teachings of the present invention there is provided a food container with a closure including: at least one sensor selected from the group consisting of: a closure sensor responsive to the closure being partially or totally opened, and an insertion sensor responsive to an article being entered into the container or displacing a semi flexible floor situated in the container, and at least one audio device responsive to the at least one sensor. According to further embodiments of the present invention, the food container further includes at least one internet service module responsive to the at least one sensor, wherein the at least one internet service module is configured for readily connecting a mobile device to an internet service provider. According to still further embodiments of the present invention, the at least one audio device further includes at least one of: a multimedia module including a speaker, and a radio device. According to yet further embodiments of the present invention, the food container further includes an energy module for readily providing power to at least one of the at least one audio device or at least one the internet service module. According to further embodiments of the present invention, the energy module is selected from the group consisting of: a chargeable battery connected to a power supply, a fuel cell chargeable by a fuel reservoir, and a solar cell array connected to a chargeable battery. According to still further embodiments of the present invention, the food container further includes a communications module selected from the group consisting of: a cellular communication module, a satellite communication module, a Bluetooth communication module, an RF communication module, a local area network communication module an IR communication module and a wired communication module. According to further teachings of the present invention there is provided a drink container including: a body for accommodating drink, a closure for closing the container, and a communications module. According to further embodiments of the present invention, the communications module further includes an internet service module responsive to opening the drink container, the internet service module configured for connecting a mobile device to an internet service provider. According to still further embodiments of the present invention, the communications module is selected from the group consisting of: a cellular communication module, a satellite communication module, a Bluetooth communication module, an RF communication module, a local area network communication module an IR communication module and a wired communication module. According to still further embodiments of the present invention, the communications module readily facilitates communication with a remote apparatus. According to further embodiments of the present invention, the remote apparatus is selected from the group consisting of: a computer, a PDA, a Cell phone and a vending machine. According to still further teachings of the present invention there is provided a food/drink vending machine including: a plurality of bases for food packages, a plurality of food packages, wherein each of the food packages is associated with a base selected from the plurality of bases, at least one sensor responsive to vending at least one of the plurality of food packages, and a communications module. According to further embodiments of the present invention, the food/drink vending machine further includes a cooling unit for controlling the temperature of the plurality of food packages. According to still further embodiments of the present invention, the food/drink vending machine further includes a module selected from the group consisting of: a multimedia module, a radio module, a biometric module, a cellular module and an internet service modules responsive to activation of the vending machine. According to yet further teachings of the present invention there is provided a drink dispenser for dispensing drinks to individuals, the drink dispenser including: a dispensing mechanism for readily dispensing drinks to individuals, at least one sensor responsive to activation of the drink dispenser, and a communication module selected from the group consisting of: a cellular communication module, a satellite communication module, a Bluetooth communication module, an RF communication module, a local area network communication module an IR communication module and a wired communication module. According to further embodiments of the present invention, the dispensing mechanism further includes a water supply selected from the group consisting of: a water reservoir and a domestic water supply. According to still further embodiments of the present invention, the drink dispenser further includes a module selected from the group consisting of: a multimedia module, a radio module, a cellular module and an internet service modules responsive to activation of the vending machine. According to further teachings of the present invention there is provided a transport container including: a body for accommodating goods, a closure for closing the container, at least one telemetry sensor selected from the group consisting of: a temperature sensor, a humidity sensor, a motion sensor, a security sensor, and an integrity sensor, and a communications module for readily communicating readings of the telemetry sensor, the communications module selected from the group consisting of: a cellular communication module, a satellite communication module, a Bluetooth communication module, an RF communication module, a local area network communication module an IR communication module and a wired communication module. According to further embodiments of the present invention, the transport container further includes a mechanism selected from the group consisting of: a cooling mechanism and an access control biometric mechanism. BRIEF DESCRIPTION OF THE FIGURES The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. Hereinafter the term “multimedia” shall include any sound, audio, video, music and the like. Hereinafter the term “multimedia module” shall include any multimedia system and/or equipment capable of producing sound, audio, video, music and the like. Hereinafter, the term “transport container” shall include, but will not be limited to, commercial containers for the purpose of transporting by way of sea, air, rail or land as well as containers known as “20 foot containers” and “40 foot containers”. Hereinafter, the term “array” shall include, but will not be limited to, a group, a number, or a quantity of things or a functional arrangement of interrelated objects, devices, components or items of equipment. In the figures: FIG. 1 illustrates a first drink container with a communications module; FIG. 2 illustrates a second drink container with a communications module; FIG. 3 illustrates a food container with an audio device responsive to a sensor; FIG. 4 illustrates an adapter component array for use with preferred embodiments of the present invention; FIG. 5 illustrates a transport container with a telemetry sensor; FIG. 6 illustrates a vending machine with a communication module; FIG. 7 illustrates a first drink dispenser with a communication module; and FIG. 8 illustrates a second drink dispenser with a communication module. DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is a food/drink container with a multimedia module. A multimedia module is combined with a food/drink container for sounding voices and/or projecting images or movies in a predetermined condition e.g., when opening the container or when removing a label. The system can be built with the container as a common part or is produced to install with any existing food/drink container as a retrofit. The present invention provides a food/drink container with a multimedia module for providing multimedia, sound and music and/or projecting an image or a movie from inside the container such that the image or movie are readily viewable from the exterior of the container. The music, sound and multimedia are readily audible and/or visible to users by way of a speaker or speakers. The multimedia module preferably includes a laser or light projector for projecting images and/or movies, a speaker or speakers for sounding the music, sound and/or audio, a memory that stores the sound, multimedia and the images and movies, an electronic system for projecting the images via the projector and speakers for providing sound, audio and music capabilities, a sensor or switch for recognizing that the container is being used or/and going to be use. The invention further includes a power source for operating the system and the projected walls are made of a material facilitating viewing from the exterior of the container of images projected inside the container. In a preferred embodiment, the food/drink container can includes either a system for reproducing music or a system for projecting movies and/or images or both. The present invention includes a sensor or switch to recognize a predetermined condition for operating the system, as a switch or sensor to recognize opening of the container or recognize users' action in order to operate the multimedia module. The sensors can include a variety of sensors e.g., a pressure sensor for sensing the pressure of a spoon on the floor of the container or sense the users' pressure on the container walls, a sensor for sensing the removal of a label from the container, a photoelectric cell for sensing light entering the container pursuant to opening the container and/or other switches and sensors for recognizing a condition for activating the multimedia module. The multimedia module is operated by an action of the user e.g., opening the container, removing a label and so on. In the embodiment of music only, the electronic system starts to play a music that is held in a memory and sound the music via a speaker or speakers. In the embodiment of full multimedia, the multimedia module of the present invention has a laser or light projector that project images on the inside walls, in some cases by using mirrors, and the walls are made of a material that enables these images to be seen from the outside while sounds are played via speaker. The voice and the images are stored in a memory and operated by an electronic system that includes a disposal power source. The principles and operation of the food/drink container with a multimedia module, according to the present invention may be better understood with reference to the drawing and the accompanying description. Referring now to the drawing, FIG. 1 illustrates a drink container 63 with a closure 202 . Drink container 63 preferably includes a multimedia module 62 . Preferably, drink container 63 includes an earphone jack 65 for readily accommodating an earphone plug 66 of an earphone 68 or an earphone set 70 . Preferably, drink container 63 accommodates an electronic and projecting unit 20 . Preferably, drink container 63 includes at least one speaker 16 (two speakers 16 are shown in FIG. 1 ). When the user uses an opener 72 to open drink container 63 , the opening of drink container 63 is sensed by a sensor 74 and operates electronic and projecting unit 20 . Optionally, a control module 295 uses images and sounds that are held in memory unit 296 to project images on a wall 14 of drink container 63 and sound voices via speakers 16 for a period of time. Preferably, control module 295 is electronically attached to or integrally formed with a radio device 28 facilitating a user to listen to radio device 28 at will. Preferably, radio device 28 is preset to a given station according to the intended consumers of drink 18 contained in drink container 63 . Preferably, drink container 63 includes a cellular module 76 for readily facilitating a user to use drink container 63 as a cellular phone pre-charged with a predetermined value of calls. Thus, cellular module 76 can utilize an earphone jack 78 for readily accommodating an earphone plug 80 , which earphone plug 80 is attached to, or integrally formed with an earphone 82 or earphone set 84 . Preferably earphone 82 or earphone set 84 includes or is integrally formed with a microphone 86 for readily facilitating two-way conversations with cellular module 76 . Preferably, drink container 63 includes an array of photo-electric cells 220 for readily generating power for drink container 63 . Preferably control module 295 controls cellular module 76 . Preferably, drink container 63 includes a component array 250 . Component array 250 includes a drink conduit 230 for readily facilitating flow of drink 18 and/or activation of components within component array 250 . Drink conduit 230 includes an inflow duct 276 for readily facilitating flow of drink 18 subsequently to opening of closure 202 . Drink conduit 230 also preferably includes an outflow duct 208 for readily facilitating flow of liquids into drink container 63 . Outflow duct includes a unidirectional flow control 206 for preventing drink 18 from entering component array through outflow duct 208 . Preferably, a purification filter 224 purifies liquids flowing through outflow duct 208 into drink 18 . For the purpose of sealing drink conduit 230 to a bottom 278 of drink container 63 , drink container 63 further includes a sealer 212 . Drink conduit 230 is preferably secured to drink container 63 by way of a conduit securer 214 . Optionally, outflow of liquids through outflow duct 208 is enhanced by a liquid pump 216 . Liquid pump 216 is powered by a power supply selected from the group consisting of: a main power supply 240 , a fuel cell 280 and photo electric array 220 . Optionally, a fiber optic controller 222 is configured to fiber optically control at least one component of component array 250 . An activator 226 is activated subsequent to opening drink container 63 with opener 72 . Optionally, drink 18 is carbonated and thus a pressure larger than one atmosphere is created in drink container 63 . Subsequently to opening drink container 63 with opener 72 , pressure in drink container 63 drops to the same pressure as the surrounding environment. Thus, the pressure reduction reduces the pressure applied by drink 18 on activator 226 and bias 275 displaces displacement element 273 thereby activating activator 226 . Preferably, activator 226 is selected from the group consisting of: a pressure switch, an electrical switch, an electronic switch, a mechanical switch and an acoustic switch. Optionally, for the purpose of preventing flow of drink 18 out of drink container 63 a seal 288 is attached to or integrally formed with drink conduit 230 . A seal breaker 292 is attached to, or integrally formed with component array 250 such that attaching component array 250 to drink container 63 breaches seal 288 and readily facilitates of drink 18 into drink conduit 230 . Preferably, component array 250 includes a compressed hydrogen container 260 for readily providing hydrogen to fuel cell 280 by way of a gas pipe 232 . Preferably, conduit securer 214 readily secures fuel cell 280 and aligns inflow duct 206 and outflow duct 208 . A pressure valve 261 is attached to, or integrally formed with, compressed hydrogen container 260 for readily controlling the pressure and/or quantities of hydrogen flowing from hydrogen container 260 to fuel cell 280 . Optionally, a hydrogen container securing element 228 is provided for securing hydrogen container 260 to component array 250 . Fuel cell 280 is geared towards an electrochemical conversion. Fuel cell 280 preferably produces electricity from fuel on an anode side 234 and an oxidant on a cathode side 281 , which react in the presence of an electrolyte 244 . The reactants flow into fuel cell 280 , and the reaction products flow out of fuel cell 280 by way of flow pipe 236 , while electrolyte 244 remains within fuel cell 280 . Fuel cell 280 preferably operates substantially continuously as long as the flow to anode side 234 and cathode side 281 is maintained. Fuel cell 280 is selected from the group consisting of an electrochemical cell, at least one battery which at least one battery consumes a reactant from an external source, which must be replenished, a thermodynamically open system, at least one battery storing electrical energy chemically and a thermodynamically closed system. Preferably and as shown in FIG. 1 , fuel cell 280 is a hydrogen fuel cell including hydrogen as its fuel and oxygen from air as its oxidant. Hydrogen flows from hydrogen container 260 to anode side 234 and comes into contact with oxygen flowing from air flowing from outside drink container 63 through a filtered aperture 268 formed in drink container 63 . Air flowing from filtered aperture 268 formed in drink container 63 travels through air pipe 269 to cathode side 281 , thereby providing the oxygen as the oxidant. Alternatively and by way of example only, other usable fuels instead of hydrogen include hydrocarbons and alcohols. By way of example only, other oxidants can include chlorine and chlorine dioxide. Optionally, a catalyst 242 is situated between anode side 234 and cathode side 281 . Preferably, drink container 63 includes a component array closure 290 . Preferably, component array closure 290 is secured to drink container by locking mechanism 254 . Locking mechanism 254 is geared toward securing and locking component array closure 290 to drink container 63 . Preferably, component array closure 290 is readily removable by the manufacturer or filler of drink 18 for the purpose of access, refueling fuel cell 280 and maintenance of component array 250 . By way of an example only, an electromechanical solenoid 252 includes an electromagnetically inductive coil 256 , wound around a displaceable armature 248 . Electromagnetically inductive coil 256 is shaped such that displaceable armature 248 is readily displaced in and out of the center of electromechanical solenoid 252 , altering inductance of electromagnetically inductive coil 256 and thereby becoming an electromagnet. Displaceable armature 248 is geared towards providing a mechanical force to locking mechanism 254 . The force applied to displaceable armature 248 is proportional to the change in inductance of electromagnetically inductive coil 256 with respect to the change in position of displaceable armature 248 , and the current flowing through electromagnetically inductive coil 256 . The force applied to displaceable armature 248 will displace displaceable armature 248 in a direction that increases the inductance of electromagnetically inductive coil 256 . Component array 250 preferably includes an antenna 270 for transceiving responsively to cellular module 76 . For the purpose of enhancing output and reception levels, antenna 270 is preferably a directional antenna or a horn antenna. Component array 250 preferably includes at least one interface selected from the group consisting of: a USB interface 258 , a PDA interface 262 , a cellular interface 264 , a memory card interface 266 , a computer interface 272 and a control interface 274 . Component array 250 preferably includes a photographic module 299 geared towards capturing still images, clips and video images. Component array 250 preferably includes an omni-directional antenna 298 for low power transmission. Component array preferably utilizes drink 18 for cooling at least one component of component array 250 . Drink 18 flows through a cooling mechanism 286 . Preferably a valve mechanism 284 controls the flow of drink 18 through cooling mechanism 286 . Cooling mechanism is geared towards cooling a management module 294 , control module 295 and memory unit 296 . A cooling exit 297 readily facilitates flow of drink 18 subsequent to drink 18 cooling at least one component of component array 250 . Preferably, a unidirectional valve 285 connects cooling exit 297 and facilitates flow of drink 18 from cooling exit 297 into flow pipe 236 . Preferably, component array 250 is secured to drink container 63 by way of a locking mechanism 231 . Locking mechanism 231 is geared towards fitting, replacing and/or recycling, maintenance and re-use of component array 250 in additional drink containers 63 . Management module 294 preferably manages and controls energy consumption of component array 250 . Optionally memory unit 296 is a “flash” memory unit. For the purpose of sealing an upper surface 282 of component array 250 , drink container 63 further includes a drink conduit 230 . Drink conduit 230 is preferably secured to drink container 63 by way of a conduit securer 214 . FIG. 2 illustrates a bottled drink container 500 . Preferably bottled drink container 500 includes a bottle closure 501 . Like above, bottled drink container 500 preferably includes a multimedia module 62 . Preferably, bottled drink container 500 includes an earphone jack 65 for readily accommodating an earphone plug 66 of an earphone 68 or an earphone set 70 . Preferably, bottled drink container 500 accommodates an electronic and projecting unit 20 . Preferably, bottled drink container 500 includes at least one speaker 16 . When the user uses opens bottle closure 501 , the opening of bottled drink container 500 is sensed by a sensor 74 and operates electronic and projecting unit 20 . Optionally, a control module 295 uses images and sounds that are held in memory unit 296 to project images on a wall 14 of bottled drink container 500 and sound voices via speaker 16 for a period of time. Preferably, control module 295 is electronically attached to or integrally formed with a radio device 28 facilitating a user to listen to radio device 28 at will. Preferably, radio device 28 is preset to a given station according to the intended consumers of drink 18 contained in bottled drink container 500 . Preferably, bottled drink container 500 includes a cellular module 76 for readily facilitating a user to use bottled drink container 500 as a cellular phone pre-charged with a predetermined value of calls. Thus, cellular module 76 can utilize an earphone jack 78 for readily accommodating an earphone plug 80 , which earphone plug 80 is attached to, or integrally formed with an earphone 82 or earphone set 84 . Preferably earphone 82 or earphone set 84 includes or is integrally formed with a microphone 86 for readily facilitating two-way conversations with cellular module 76 . Preferably, bottled drink container 500 includes an array of photo-electric cells 220 for readily generating power for bottled drink container 500 . Preferably control module 295 controls cellular module 76 . Preferably, bottled drink container 500 includes a component array 250 . Component array 250 includes a drink conduit 230 for readily facilitating flow of drink 18 and/or activation of components within component array 250 . For the purpose of sealing an upper surface 282 of component array 250 , drink conduit 230 is preferably secured to bottled drink container 500 by way of a conduit securer 214 . Similarly, drink conduit 230 includes an inflow duct 276 for readily facilitating flow of drink 18 subsequently to opening of bottle closure 501 . Drink conduit 230 also preferably includes an outflow duct 208 for readily facilitating flow of liquids into bottled drink container 500 . Outflow duct includes a unidirectional flow control 206 for preventing drink 18 from entering component array through outflow duct 208 . Preferably, a purification filter 224 purifies liquids flowing through outflow duct 208 into drink 18 . For the purpose of sealing drink conduit 230 to a bottle bottom 503 of bottled drink container 500 , bottled drink container 500 further includes a sealer 212 . Drink conduit 230 is preferably secured to bottled drink container 500 by way of a conduit securer 214 . Optionally, outflow of liquids through outflow duct 208 is enhanced by a liquid pump 216 . Liquid pump 216 is powered by a power supply selected from the group consisting of: a main power supply 240 , a fuel cell 280 and photo electric array 220 . Optionally, a fiber optic controller 222 is configured to fiber optically control at least one component of component array 250 . An activator 226 is activated subsequent to opening bottled drink container 500 with bottle closure 501 . Optionally, drink 18 is carbonated and thus a pressure larger than one atmosphere is created in bottled drink container 500 . Subsequently to opening bottled drink container 500 , pressure in bottled drink container 500 drops to the same pressure as the surrounding environment. Thus, the pressure reduction reduces the pressure applied by drink 18 on activator 226 and bias 275 displaces displacement element 273 thereby activating activator 226 . Preferably, activator 226 is selected from the group consisting of: a pressure switch, an electrical switch, an electronic switch, a mechanical switch and an acoustic switch. Optionally, for the purpose of preventing flow of drink 18 out of bottled drink container 500 a seal 288 is attached to or integrally formed with drink conduit 230 . A seal breaker 292 is attached to, or integrally formed with component array 250 such that attaching component array 250 to bottled drink container 500 breaches seal 288 and readily facilitates of drink 18 into drink conduit 230 . Preferably, component array 250 includes a compressed hydrogen container 260 for readily providing hydrogen to fuel cell 280 by way of a gas pipe 232 . Preferably, conduit securer 214 readily secures fuel cell 280 and aligns inflow duct 206 and outflow duct 208 . A pressure valve 261 is attached to, or integrally formed with, compressed hydrogen container 260 for readily controlling the pressure and/or quantities of hydrogen flowing from hydrogen container 260 to fuel cell 280 . Optionally, a hydrogen container securing element 228 is provided for securing hydrogen container 260 to component array 250 . Fuel cell 280 is geared towards an electrochemical conversion. Fuel cell 280 preferably produces electricity from fuel on an anode side 234 and an oxidant on a cathode side 281 , which react in the presence of an electrolyte 244 . The reactants flow into fuel cell 280 , and the reaction products flow out of fuel cell 280 by way of flow pipe 236 , while electrolyte 244 remains within fuel cell 280 . Fuel cell 280 preferably operates substantially continuously as long as the flow to anode side 234 and cathode side 281 is maintained. Fuel cell 280 is selected from the group consisting of an electrochemical cell, at least one battery which at least one battery consumes a reactant from an external source, which must be replenished, a thermodynamically open system, at least one battery storing electrical energy chemically and a thermodynamically closed system. Preferably and as shown in FIG. 2 , fuel cell 280 is a hydrogen fuel cell including hydrogen as its fuel and oxygen from air as its oxidant. Hydrogen flows from hydrogen container 260 to anode side 234 and comes into contact with oxygen flowing from air flowing from outside bottled drink container 500 through a filtered aperture 268 formed in bottled drink container 500 . Air flowing from filtered aperture 268 formed in bottled drink container 500 travels through air pipe 269 to cathode side 281 , thereby providing the oxygen as the oxidant. Alternatively and by way of example only, other usable fuels instead of hydrogen include hydrocarbons and alcohols. By way of example only, other oxidants can include chlorine and chlorine dioxide. Optionally, a catalyst 242 is situated between anode side 234 and cathode side 281 . Preferably, bottled drink container 500 includes a component array closure 290 . Preferably, component array closure 290 is secured to drink container by locking mechanism 254 . Locking mechanism 254 is geared toward securing and locking component array closure 290 to bottled drink container 500 . Preferably, component array closure 290 is readily removable by the manufacturer or filler of drink 18 for the purpose of access, refueling fuel cell 280 and maintenance of component array 250 . By way of an example only, an electromechanical solenoid 252 includes an electromagnetically inductive coil 256 , wound around a displaceable armature 248 . Electromagnetically inductive coil 256 is shaped such that displaceable armature 248 is readily displaced in and out of the center of electromechanical solenoid 252 altering inductance of electromagnetically inductive coil 256 and thereby becoming an electromagnet. Displaceable armature 248 is geared towards providing a mechanical force to locking mechanism 254 . The force applied to displaceable armature 248 is proportional to the change in inductance of electromagnetically inductive coil 256 with respect to the change in position of displaceable armature 248 , and the current flowing through electromagnetically inductive coil 256 . The force applied to displaceable armature 248 will displace displaceable armature 248 in a direction that increases the inductance of electromagnetically inductive coil 256 . Component array 250 preferably includes an antenna 270 for transceiving responsively to cellular module 76 . For the purpose of enhancing output and reception levels, antenna 270 is preferably a directional antenna or a horn antenna. Component array 250 preferably includes at least one interface selected from the group consisting of: a USB interface 258 , a PDA interface 262 , a cellular interface 264 , a memory card interface 266 , a computer interface 272 and a control interface 274 . Component array 250 preferably includes a photographic module 299 geared towards capturing still images, clips and video images. Component array 250 preferably includes an omni-directional antenna 298 for low power transmission. Component array preferably utilizes drink 18 for cooling at least one component of component array 250 . Drink 18 flows through a cooling mechanism 286 . Preferably, a valve mechanism 284 controls the flow of drink 18 through cooling mechanism 286 . Cooling mechanism is geared towards cooling a management module 294 , control module 295 and memory unit 296 . A cooling exit 297 readily facilitates flow of drink 18 subsequent to drink 18 cooling at least one component of component array 250 . Preferably, a unidirectional valve 285 connects cooling exit 297 and facilitates flow of drink 18 from cooling exit 297 into flow pipe 236 . Preferably, component array 250 is secured to bottled drink container 500 by way of a locking mechanism 231 . Locking mechanism 231 is geared towards fitting, replacing and/or recycling, maintenance and re-use of component array 250 in additional bottled drink containers 500 . Management module 294 preferably manages and controls energy consumption of component array 250 . FIG. 3 illustrates a food container 10 includes a food 305 . Food container 10 includes a semi flexible floor 50 . Preferably, a user inserts an article such as a spoon 52 for the purpose of consuming food 305 . Preferably, thereafter spoon 52 displaces flexible floor 50 thereby triggering a pressure switch 316 , which pressure switch 316 activates an audio device 54 . Audio device 54 plays music, tones or a voice recording via a speaker 56 substantially during, before or after food 305 is consumed. Preferably, an electronic and projecting unit 20 is electronically attached to or integrally formed with radio device 28 facilitating a user to listen to radio device 28 at will. Preferably, radio device 28 is preset to a given station according to the intended consumers of food 305 contained in food container 10 . Like above, food container 10 includes a cellular module 76 for readily facilitating a user to use food container 10 as a cellular phone pre-charged with a predetermined value of calls. Thus, cellular module 76 can utilizes earphone jack 32 for readily accommodating earphone plug 34 , which earphone plug 34 is attached to, or integrally formed with earphone 36 or earphone set 38 . Preferably earphone 36 or earphone set 38 include or are integrally formed with microphone 40 for readily facilitating two-way conversations with cellular module 76 . Preferably, food container 10 includes food 305 and a communication module 58 . Communication module 58 is preferably selected from the group consisting of, a cellular communication module, a satellite communication module, a Bluetooth communication module, an RF communication module, a local area network communication module an IR communication module and a wired communication module. Communication module 58 preferably readily facilitates communication with a remote apparatus 60 . Preferably, remote apparatus 60 is selected from the group consisting of: a computer, a PDA and a Cell phone. Preferably, a multimedia module 375 is electronically attached to, or integrally formed with food container 10 such that multimedia module 375 can be remotely activated by a user, thereby inducing a child to consume the contents of food container 10 . Food container 10 includes a food closure 310 and accommodates an electronic and projecting unit 20 . When the user uses opens food closure 310 and enters an a article such as spoon 52 , into food container 10 is sensed by an entry sensor 251 and optionally operates electronic and projecting unit 20 . Optionally, a control module 365 uses images and/or sounds held in a memory unit 380 to project images on a wall 318 of food container 10 and sound voices via speaker 56 for a period of time. Preferably, control module 365 is electronically attached to or integrally formed with radio device 28 facilitating a user to listen to radio device 28 at will. Preferably, food container 10 includes an array of photo-electric cells 220 for readily generating power for food container 10 . Preferably control module 365 controls cellular module 76 . Preferably, food container 10 includes a food component array 350 . Food component array 350 includes a plunger 330 for readily facilitating displacement by spoon 52 displacing flexible floor 50 and/or activation of components within food component array 350 . Optionally, remote apparatus 60 controls food component array 350 . For the purpose of sealing plunger 330 to an upper surface 282 of food component array 350 , food container 10 further includes a plunger conduit 340 . Plunger conduit 340 is preferably secured to food container 10 by way of a plunger conduit securer 325 . Optionally, a fiber optic controller 222 is configured to fiber optically control at least one component of food component array 350 . A food activator 316 is activated subsequent to displacing plunger 330 . Preferably, food activator 316 is selected from the group consisting of: a pressure switch, an electrical switch, an electronic switch, a mechanical switch and an acoustic switch. Like above, food component array 350 includes a compressed hydrogen container 260 for readily providing hydrogen to a fuel cell 280 by way of a gas pipe 232 . Preferably, plunger conduit securer 325 readily secures fuel cell 280 . A pressure valve 261 is attached to, or integrally formed with, compressed hydrogen container 260 for readily controlling the pressure and/or quantities of hydrogen flowing from hydrogen container 260 to fuel cell 280 . Optionally, a hydrogen container securing element 228 is provided for securing hydrogen container 260 to food component array 350 . Fuel cell 280 is geared towards an electrochemical conversion. Fuel cell 280 preferably produces electricity from fuel on an anode side 234 and an oxidant on a cathode side 281 , which react in the presence of an electrolyte 244 . The reactants flow into fuel cell 280 , and the reaction products flow out of fuel cell 280 by way of a flow pipe 236 , while electrolyte 244 remains within fuel cell 280 . Fuel cell 280 preferably operates substantially continuously as long as the flow to anode side 234 and cathode side 281 is maintained. Fuel cell 280 is selected from the group consisting of an electrochemical cell, at least one battery which at least one battery consumes a reactant from an external source, which must be replenished, a thermodynamically open system, at least one battery storing electrical energy chemically and a thermodynamically closed system. Preferably and as shown in FIG. 3 as well, fuel cell 280 is a hydrogen fuel cell including hydrogen as its fuel and oxygen from air as its oxidant. Hydrogen flows from hydrogen container 260 to anode side 234 and comes into contact with oxygen flowing from air flowing from outside food container 10 through a filtered aperture 268 formed in food container 10 . Air flowing from filtered aperture 268 formed in food container 10 travels through an air pipe 269 to cathode side 281 , thereby providing the oxygen as the oxidant. Alternatively and by way of example only, other usable fuels instead of hydrogen include hydrocarbons and alcohols. By way of example only, other oxidants can include chlorine and chlorine dioxide. Optionally, a catalyst 242 is situated between anode side 234 and cathode side 281 . Preferably, food container 10 includes a component array closure 290 . Preferably, component array closure 290 is secured to drink container by a locking mechanism 254 . Locking mechanism 254 is geared toward securing and locking component array closure 290 to food container 10 . Preferably, component array closure 290 is readily removable by the manufacturer or filler of food 305 for the purpose of access, refueling fuel cell 280 and maintenance of food component array 350 . By way of an example only, an electromechanical solenoid 252 includes an electromagnetically inductive coil 256 , wound around a displaceable armature 248 . Electromagnetically inductive coil 256 is shaped such that displaceable armature 248 is readily displaced in and out of the center of electromechanical solenoid 252 , altering inductance of electromagnetically inductive coil 256 and thereby becoming an electromagnet. Displaceable armature 248 is geared towards providing a mechanical force to locking mechanism 254 . The force applied to displaceable armature 248 is proportional to the change in inductance of electromagnetically inductive coil 256 with respect to the change in position of displaceable armature 248 , and the current flowing through electromagnetically inductive coil 256 . The force applied to displaceable armature 248 will displace displaceable armature 248 in a direction that increases the inductance of electromagnetically inductive coil 256 . Food component array 350 preferably includes a multi channel antenna 298 for transceiving responsively to cellular module 76 . Food component array 350 preferably includes at least one interface selected from the group consisting of: a USB interface 258 , a PDA interface 262 , a cellular interface 264 , a memory card interface 266 , a computer interface 272 and a control interface 274 . Food component array 350 preferably includes a photographic module 299 geared towards capturing still images, clips and video images. Preferably, multi channel antenna 298 is an omni-directional antenna for low power transmission. Component array preferably utilizes food 305 for cooling at least one component of food component array 350 . Cellular module 76 is powered by a power supply selected from the group consisting of: a main power supply 240 , a fuel cell 280 and photo electric array 220 . Preferably, food component array 350 is secured to food container 10 by way of a locking mechanism 231 . Locking mechanism 231 is geared towards fitting, replacing and/or recycling, maintenance and re-use of food component array 350 in additional food containers 10 . For the purpose of controlling energy output and energy consumption of food component array 350 , an energy controller 360 is provided. For the purpose of remote control of management of food component array 350 , a remote controller 370 is provided. Optionally, flow pipe 236 has a flow reservoir 390 for collection of output from flow pipe 236 . Food component array 350 preferably includes an antenna 270 for transceiving responsively to cellular module 76 . For the purpose of enhancing output and reception levels, antenna 270 is preferably a directional antenna or a horn antenna. FIG. 4 illustrates array adapter 400 with an audio device 54 geared towards playing music, tunes or voice recordings, via a speaker 56 . Preferably, an electronic and projecting unit 20 is electronically attached to or integrally formed with radio device 28 facilitating a user to listen to radio device 28 at will. Preferably, radio device 28 is preset to a given station. Array adapter 400 includes a cellular module 76 for readily facilitating a user to use array adapter 400 as a cellular phone pre-charged with a predetermined value of calls. Thus, cellular module 76 can utilizes earphone jack 32 for readily accommodating earphone plug 34 , which earphone plug 34 is attached to, or integrally formed with earphone 36 or earphone set 38 . Preferably earphone 36 or earphone set 38 include or are integrally formed with microphone 40 for readily facilitating two-way conversations with cellular module 76 . Preferably, array adapter 400 includes a communication module 58 . Communication module 58 is preferably selected from the group consisting of: a cellular communication module, a satellite communication module, a Bluetooth communication module, an RF communication module, a local area network communication module an IR communication module and a wired communication module. Communication module 58 preferably readily facilitates communication with a remote apparatus 60 . Preferably, remote apparatus 60 is selected from the group consisting of: a computer, a PDA and a Cell phone. Preferably, a multimedia module 375 is electronically attached to, or integrally formed with array adapter 400 such that multimedia module 375 can be remotely activated by a user. Preferably, a control module 365 is electronically attached to or integrally formed with radio device 28 facilitating a user to listen to radio device 28 at will. Preferably control module 365 controls cellular module 76 . Preferably, array adapter 400 includes an adapter component array 450 . Adapter component array 450 includes an external hydrogen supply 430 . For the purpose of sealing external hydrogen supply 430 to an upper surface 282 of adapter component array 450 , array adapter 400 further includes an external supply conduit 444 . External supply conduit 444 is preferably secured to array adapter 400 by way of an external supply conduit securer 414 . Optionally, a fiber optic controller 222 is configured to fiber optically control at least one component of adapter component array 450 . For the purpose of controlling energy output and energy consumption of adapter component array 450 , an energy controller 360 is provided. Energy controller 360 also controls flow of hydrogen through external hydrogen supply 430 by way of a flow controller 428 geared towards controlling flow of hydrogen through external hydrogen supply 430 . Like above, adapter component array 450 includes a compressed hydrogen container 260 for readily providing hydrogen to a fuel cell 280 by way of a gas pipe 232 . Preferably, an external supply conduit securer 414 readily secures fuel cell 280 . A pressure valve 261 is attached to, or integrally formed with, compressed hydrogen container 260 for readily controlling the pressure and/or quantities of hydrogen flowing from hydrogen container 260 to fuel cell 280 . Preferably, energy controller 360 controls opening and closing pressure valve 261 as well as the quantity of hydrogen passing from compressed hydrogen container 260 . Optionally, a hydrogen container securing element 228 is provided for securing hydrogen container 260 to adapter component array 450 . Fuel cell 280 is geared towards an electrochemical conversion. Fuel cell 280 preferably produces electricity from fuel on an anode side 234 and an oxidant on a cathode side 281 , which react in the presence of an electrolyte 244 . The reactants flow into fuel cell 280 , and the reaction products flow out of fuel cell 280 by way of a flow pipe 236 , while electrolyte 244 remains within fuel cell 280 . Fuel cell 280 preferably operates substantially continuously as long as the flow to anode side 234 and cathode side 281 is maintained. Fuel cell 280 is selected from the group consisting of an electrochemical cell, at least one battery which at least one battery consumes a reactant from an external source, which must be replenished, a thermodynamically open system, at least one battery storing electrical energy chemically and a thermodynamically closed system. Preferably and as shown in FIG. 4 as well, fuel cell 280 is a hydrogen fuel cell including hydrogen as its fuel and oxygen from air as its oxidant. Hydrogen flows from hydrogen container 260 to anode side 234 and comes into contact with oxygen flowing from air flowing from outside adapter component array 450 through a filtered aperture 268 formed in adapter component array 450 . Air flowing from filtered aperture 268 formed in adapter component array 450 travels through an air pipe 269 to cathode side 281 , thereby providing the oxygen as the oxidant. Alternatively and by way of example only, other usable fuels instead of hydrogen include hydrocarbons and alcohols. By way of example only, other oxidants can include chlorine and chlorine dioxide. Optionally, a catalyst 242 is situated between anode side 234 and cathode side 281 . Preferably, adapter component array 450 includes a locking mechanism 254 . Locking mechanism 254 is geared toward securing and locking adapter component array 450 to array adapter 400 . Preferably, a component array closure 290 is readily removable by the manufacturer or a technician of array adapter 400 for the purpose of access, refueling fuel cell 280 and maintenance of adapter component array 450 . By way of an example only, an electromechanical solenoid 252 includes an electromagnetically inductive coil 256 , wound around a displaceable armature 248 . Electromagnetically inductive coil 256 is shaped such that displaceable armature 248 is readily displaced in and out of the center of electromechanical solenoid 252 , altering inductance of electromagnetically inductive coil 256 and thereby becoming an electromagnet. Displaceable armature 248 is geared towards providing a mechanical force to locking mechanism 254 . The force applied to displaceable armature 248 is proportional to the change in inductance of electromagnetically inductive coil 256 with respect to the change in position of displaceable armature 248 , and the current flowing through electromagnetically inductive coil 256 . The force applied to displaceable armature 248 will displace displaceable armature 248 in a direction that increases the inductance of electromagnetically inductive coil 256 . Adapter component array 450 preferably includes a multi channel antenna 298 for transceiving responsively to cellular module 76 . Adapter component array 450 preferably includes at least one interface selected from the group consisting of: a USB interface 258 , a PDA interface 262 , a cellular interface 264 , a memory card interface 266 , a computer interface 272 and a control interface 274 . Adapter component array 450 preferably includes a photographic module 299 geared towards capturing still images, clips and video images. Multi channel antenna 298 is preferably an omni-directional antenna for low power transmission. Cellular module 76 is powered by a power supply selected from the group consisting of: a main power supply 240 , a fuel cell 280 and photo electric array 220 . Preferably, adapter component array 450 is secured to array adapter 400 by way of a locking mechanism 231 . Locking mechanism 231 is geared towards fitting, replacing and/or recycling, maintenance and re-use of adapter component array 450 in additional adapter component arrays 450 . For the purpose of remote control of management of adapter component array 450 , a remote controller 370 is provided. Preferably, array adapter 400 includes a coupler 410 for readily coupling and/or attaching array adapter 400 to electronic equipment, utility items, food containers, drink containers and the like. Preferably, array adapter 400 includes an external power supplier 420 for external power supply to at least one component in adapter component arrays 450 . Preferably, array adapter 400 includes an external control channel 440 for the purpose of wired communicating with external components and equipment as well as electronic equipment, utility items, food containers, drink containers and the like. A unidirectional valve 408 is attached to or integrally formed with external supply conduit 444 for the purpose of controlling flow of hydrogen from external hydrogen supply 430 . External supply conduit 444 optionally includes an attachment element 404 for the purpose of attaching and/or securing external supply conduit 444 , unidirectional valve 408 and/or external hydrogen supply 430 . Preferably, external supply conduit 444 is attached to, or integrally formed with external control channel 440 by way of a conduit attachment 460 . Optionally, external supply conduit 444 includes a control channel link 418 for readily relaying command and control links and/or instructions from external control channel 440 to adapter component array 450 . For the purpose of relaying commands and/instructions to fiber optic controller 222 , a fiber optic attachment 480 is attached to, or integrally formed with external supply conduit 444 . For the purpose of relaying power from external power supply 420 to fiber main power supply 240 , a power attachment 470 is attached to, or integrally formed with external supply conduit 444 . Preferably, external supply conduit 444 includes a power link 448 for readily relaying power from external power supply 420 to adapter component array 450 . Preferably, power link 448 is attached to, or integrally formed with power supply 240 by way of a power attachment 490 . For the purpose of controlling the content of flow reservoir 390 and/or drainage of flow reservoir 390 , a drainage pipe 434 is attached to or integrally formed with flow reservoir 390 . Preferably, drainage from flow reservoir 390 can be readily controlled upon demand or alternatively can readily facilitate drainage of flow reservoir 390 substantially continuously. Preferably, drainage pipe 434 readily facilitates removal of any material to the exterior of adapter component array 450 by way of a drainage aperture 438 formed in adapter component array 450 . Optionally a drainage valve 422 is attached to drainage aperture 438 formed in adapter component array 450 for the purpose of selective drainage of flow reservoir 390 . Optionally, control module 365 uses images and/or sounds held in a memory unit 380 . Preferably, a hydrogen connector 424 connects between unidirectional valve 408 and flow controller 428 . FIG. 5 illustrates a transport container 600 for transporting goods, food, drink and commodities. Preferably, an array adapter 400 of FIG. 4 is attached to, or integrally formed with, transport container for control and management of transport container 600 . Like above, array adapter 400 includes an audio device 54 of FIG. 4 geared towards playing music, tunes or voice recordings, via a speaker 56 of FIG. 4 . Preferably, an electronic and projecting unit 20 is electronically attached to or integrally formed with a display 612 of FIG. 5 and a radio device 28 of FIG. 4 facilitating a user to listen to radio device 28 at will. As shown in FIG. 4 , array adapter 400 includes a cellular module 76 for readily facilitating a user to use array adapter 400 as a cellular phone pre-charged with a predetermined value of calls. Thus, cellular module 76 can utilizes earphone jack 32 for readily accommodating earphone plug 34 , which earphone plug 34 is attached to, or integrally formed with earphone 36 or earphone set 38 . Preferably earphone 36 or earphone set 38 include or are integrally formed with microphone 40 for readily facilitating two-way conversations with cellular module 76 . For the purpose of clarity, array adapter 400 of FIG. 4 is expressly incorporated herein in its entirety by reference thereto. Energy controller 360 also controls flow of hydrogen through external hydrogen supply 430 by way of flow controller 428 geared towards controlling flow of hydrogen through external hydrogen supply 430 . Like above, adapter component array 450 includes a compressed hydrogen container 260 for readily providing hydrogen to a fuel cell 280 by way of a gas pipe 232 . Preferably, external supply conduit securer 414 readily secures fuel cell 280 . Preferably, an external hydrogen supply 620 is attached to, or integrally formed with transport container 600 . Preferably, an external hydrogen supply valve 605 is controlled by array adapter 400 for controlling the quantity, rate and closure of supply valve 605 . Preferably, an attachment pipe 606 connects between hydrogen supply valve 605 and external hydrogen supply 430 . Preferably, transport container 600 includes a first closure 603 and a second closure 604 similarly to transport containers known in the art. Optionally, second closure 604 includes a command panel 610 for readily controlling and displaying telemetry of transport container 600 . Preferably, transport container 600 includes at least one telemetry sensor 611 selected from the group consisting of: a temperature sensor, a humidity sensor, a motion sensor, a security sensor, and an integrity sensor. Preferably, command panel 610 includes an access control biometric mechanism 608 . For the purpose of readily facilitating transmission and/or receipt of commands from remote sources, an antenna 601 is attached to, or integrally formed with, transport container 600 and responsive to array adapter 400 . By way of example only, array adapter 400 may be retrofitted to transport containers 600 by way of situating array adapter 400 in upper part 607 of transport container 600 . Alternatively, by way of an additional non limiting example only, array adapter 400 may be retrofitted to transport containers 600 by way of situating array adapter 400 in a compartment 602 formed in first closure 603 , thereby readily facilitating retrofitting of transport container 600 by way of replacing first closure 603 . FIG. 6 illustrates a vending machine 88 with a multimedia module 90 for projecting an image or movies viewable on a display 94 . Multimedia module 90 is geared towards producing sound, music and audio by way of a speaker 96 . Vending machine 88 contains at least one food package 98 . Multimedia module 90 is operated according to predetermined criteria e.g., activating vending machine 88 , entering payment to vending machine 88 and the like. An electronic unit 100 and a projecting unit 102 project images 104 such that images 104 are viewable and images 104 can be seen from outside of vending machine 88 . Preferably, substantially contemporaneously with electronic unit 100 playing sounds via speaker 96 , images 104 or a movie, substantially together with audible music and sound are played during consumption of food package 98 by the user. Preferably, electronic unit 100 is electronically attached to or integrally formed with a radio device 106 facilitating a user to listen to the radio at will. Preferably, radio device 106 is preset to a given station according to the intended consumers of the food/drink in vending machine 88 . Preferably, electronic unit 100 is electronically attached to or integrally formed with a radio 106 facilitating a user to listen to radio device 106 at will. Preferably, radio 106 is preset to a given station according to the intended consumers of food package 98 contained in vending machine 88 . Preferably, vending machine 88 includes a cellular vending module 108 for readily facilitating a user to use a cellular phone to pay for food package 98 by billing the account of the user. Preferably, vending machine 88 includes a door shaped closure 110 for closing vending machine 88 . Preferably, vending machine 88 includes a remote control sub-system 113 for readily facilitating remote access to multimedia module 90 , a cooling unit 700 and an array adapter 400 . Preferably, array adapter 400 includes a remote command module 370 . Optionally, a remote apparatus 122 readily controls remote command module 370 . For the purpose of clarity, array adapter 400 of FIG. 4 is expressly incorporated herein in its entirety by reference thereto. Like above, array adapter 400 includes an adapter component array 450 . Adapter component array 450 includes an external hydrogen supply 430 . Optionally, remote apparatus 122 readily controls array adapter 400 of FIG. 4 . Preferably, vending machine 88 includes a communication module 120 . Communication module 120 is preferably selected from the group consisting of: a cellular communication module, a satellite communication module, a Bluetooth communication module, an RE communication module, a local area network communication module an IR communication module and a wired communication module. Communication module 120 preferably readily facilitates communication with a remote apparatus 122 . Preferably, remote apparatus 122 is selected from the group consisting of: a computer, a PDA and a Cell phone. Thus, multimedia module 90 is electronically attached to, or integrally formed with such that vending machine 88 can be remotely activated by a user. Preferably, vending machine 88 includes an access control biometric mechanism 608 for the purpose of controlling access and/or replenishing or replacement of food packages 98 . Preferably, multimedia module 90 can be used for projecting an image or movies viewable on an outside wall 92 . Multimedia module 90 is operated according to predetermined criteria e.g., opening vending machine 88 . Preferably, substantially contemporaneously with electronic unit 100 playing sounds via speaker 96 , images 104 or a movie, substantially together with audible music and sound are played during consumption of food package 98 by the user. For the purpose of readily facilitating transmission and/or receipt of commands from remote sources, an antenna 710 is attached to, or integrally formed with, vending machine 88 and responsive to array adapter 400 . Preferably, an adjustable display mount 720 situates and/or displaces display 94 to a pre-set direction. Alternatively, adjustable display mount 720 is responsive to array adapter 400 to readily control displacement of display 94 to a specific angle or substantially continuously displace display 94 . An illumination source 730 is attached to vending machine 88 and responsive to commands from array adapter 400 . By way of a non-limiting example only, illumination source 730 includes and light emitting diodes (LED) matrix 735 . Light emitting diodes (LED) matrix 735 is geared towards providing enhanced energy consumption properties and/or providing a plurality of colored illumination schemes. Door shaped closure 110 preferably includes a handle 740 for readily facilitating of access and/or replenishing or replacement of food packages 98 . A plurality of food package bases 750 are provided for the purpose of situating, storing or securing food packages 98 in vending machine 88 . Preferably, an external vending hydrogen supply 770 is attached to, or integrally formed with vending machine 88 . Preferably, an external hydrogen vending supply valve 780 is controlled by array adapter 400 for controlling the quantity, rate and closure of vending supply valve 780 . Preferably, an attachment vending pipe 790 connects between hydrogen vending supply valve 780 and external hydrogen supply 430 . Optionally, multimedia module 375 is electronically attached to, or integrally formed with vending machine 88 such that multimedia module 375 can be remotely activated by a user, thereby inducing consumption of the contents of vending machine 88 . a control module 365 is electronically attached to or integrally formed with radio device 28 facilitating a user to listen to radio device 28 at will. Preferably control module 365 controls cellular module 76 , projecting; unit 102 , multimedia module 90 , electronic unit 100 and/or radio device 106 . FIG. 7 shows a first drink dispenser 800 which utilizes a drink container 810 for the purpose of dispensing a drink 805 . Preferably, drink container 810 attaches to drink dispenser 800 by way of a drink attachment 820 . Preferably, drink attachment 820 attaches drink container 810 to drink dispenser 800 according to the methods known in the art for attaching drink containers to drink dispensers. Similarly to methods known in the art, a drink pipe 802 is provided for readily facilitating transfer of drink 805 from drink container 810 to a dispensing unit 835 . Here as well, array adapter 400 of FIG. 4 is expressly incorporated herein in its entirety by reference thereto. FIG. 7 shows array adapter 400 is preferably connected to dispensing unit 835 for the purpose of controlling and/or supervising dispensing unit 835 . Preferably, a dispensing command panel 850 includes an access control biometric mechanism 608 . Preferably, a temperature controlled outlet 860 is geared towards lowering the temperature of drink 805 to a prerequisite temperature. Preferably, an enhanced temperature outlet 865 is geared towards raising the temperature of drink 805 to a prerequisite temperature. Thus, either heated of cooled drinks 805 are readily dispensed by drink dispenser 800 . A drainage system 870 is provided for draining any overflow or spillage of drink 805 according to methods known in the art. A drainage pipe 804 preferably connects array adapter 400 and drainage system 870 . Namely, drainage valve 422 is attached to drainage aperture 438 formed in adapter component array 450 for the purpose of selective drainage of flow reservoir 390 through drainage pipe 804 to drainage system 870 . Here as well, external vending hydrogen supply 770 of FIG. 6 is expressly incorporated herein in its entirety by reference thereto. External vending hydrogen supply 770 is attached to, or integrally formed with array adapter 400 for the purpose of providing hydrogen to array adapter 400 . Preferably, drink dispenser 800 includes a plurality of indicators 840 for readily indicating proper function of drink dispenser, dispensing, drink, cooling, heating and proper function of array adapter 400 . FIG. 8 shows a second drink dispenser 900 which utilizes an external drink supply 830 for the purpose of dispensing a drink. Preferably, external drink supply 830 attaches to second drink dispenser 900 by way of an external drink attachment 920 . Preferably, external drink attachment 920 attaches external drink supply 830 to second drink dispenser 800 according to the methods known in the art for attaching external drink supplies to drink dispensers. Similarly to methods known in the art, a second drink pipe 902 is provided for readily facilitating transfer of drink from external drink supply 830 to a dispensing unit 835 . Here as well, array adapter 400 of FIG. 4 is expressly incorporated herein in its entirety by reference thereto. FIG. 8 shows array adapter 400 preferably connected to dispensing unit 835 for the purpose of controlling and/or supervising dispensing unit 835 . Here as well, a dispensing command panel 850 includes an access control biometric mechanism 608 . Preferably, a temperature controlled outlet 860 is geared towards lowering the temperature of drink to a prerequisite temperature. Preferably, an enhanced temperature outlet 865 is geared towards raising the temperature of drink to a prerequisite temperature. Thus, either heated of cooled drinks are readily dispensed by second drink dispenser 900 . Similarly, a drainage system 870 is provided for draining any overflow or spillage of drink according to methods known in the art. A second drainage pipe 904 preferably connects array adapter 400 and drainage system 870 . Namely, a drainage valve 422 is attached to drainage aperture 438 formed in adapter component array 450 for the purpose of selective drainage of flow reservoir 390 through second drainage pipe 904 to drainage system 870 . Here as well, external vending hydrogen supply 770 of FIG. 6 is expressly incorporated herein in its entirety by reference thereto. External vending hydrogen supply 770 is attached to, or integrally formed with array adapter 400 for the purpose of providing hydrogen to array adapter 400 . Preferably, second drink dispenser 900 includes a plurality of indicators 840 for readily indicating proper function of drink dispenser, dispensing, drink, cooling, heating and proper function of array adapter 400 Although the invention has been described in conjunction with specific embodiments thereof it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art, accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

1a

BACKGROUND OF THE INVENTION a) Field of the Invention This invention generally relates to devices for destroying or otherwise controlling the presence of flying insects (e.g., mosquitoes and gnats) within a prescribed area, and more particularly, to such devices that destroy the flying insects using a sticky surfactant. b) Description of the Prior Art Owing to the prevalence and general annoyance of flying insects, many devices have been developed in the past in an attempt to control their local populations, especially around people perhaps trying to enjoy the outdoors or while indoors. One of the most popular insect-control members is “fly-paper”, and although this sticky paper can take on many different forms, the basic structure is generally common and includes a substrate or supporting surface, such as a strip or structure made of paper, or a thin strip of foil made of a plastic or metal sheet, onto which a sticky material is applied, such as a pressure sensitive adhesive or a viscous coating including mineral oil. Examples of such fly papers can be found in U.S. Pat. Nos. 395,640, 532,454, 552,644, 552,762, 761,202, 807,040, 862,467, 885,615, 897,919, 919,507, 935,428, 1,194,736, 1,480,539, 1,643,118, 4,425,733. In addition to a sticky surfactant, fly paper usually includes an alluring sex hormone or chemical and/or a attracting scent (and sometimes a poison) to help attract flying insects into contact with the sticky surface. Once contact is made, the insect cannot escape. Recent efforts in the art of insect control have included the use of resonators that can be used to lure or repel insects with pressure waves (e.g., waves that mimic a heartbeat). Conventional fly paper constructions dampen or distort the pressure waves and thereby render a resonator less effective. Improvements in the construction of fly paper are needed and the present invention addresses this need. SUMMARY OF THE INVENTION An insect-control member includes a substrate having a thickness and a flexural modulus. The thickness and the flexural modulus are interrelated material properties, one value being defined by the other value so as to satisfy a prescribed criterion. The substrate supports an insect-interactive material. In a preferred application, the substrate included is flexible or semi-rigid and has a vibration-coupling surface opposite the insect-engagement surface. The vibration-coupling surface is intended to be secured to a mechanical displacement generating structure so that the insect-control member vibrates at a prescribed frequency. The prescribed frequency preferably mimics the heartbeat of an animal and is used to lure flying insects to the proximity of the device. Other cues, e.g., carbon dioxide, heat, and/or chemical lures, cause orientation and landing on the exposed sticky surface. Thus, the insect-control member of the present invention is constructed to operate as a resonating antenna while also serving as backing for an insect-interactive material such as an adhesive, pesticide, or mineral oil. In a preferred arrangement, the insect-control member is provided in a folded arrangement with the substrate folded along a fold-line so that a portion of the sticky surface abuts against a similarly sized portion of the same sticky surface. With this folded arrangement, the sticky surface is protected until the insect-control member is needed (for example, as a replacement of a used or old insect-control member), at which point the folded substrate is unfolded thereby exposing the interposed sticky material. A preferred embodiment of the insect-control member includes a perimeter seal positioned on the insect-engagement surface of the substrate, adjacent to and surrounding the sticky material. The perimeter seal is preferably made from another type of adhesive and is sized and positioned so that in the folded configuration, half of the perimeter seal seals against the remaining half and thereby encloses and seals the sticky material similar to an envelope. The purpose of the perimeter seal is to discourage the typically viscous sticky material from slowly oozing out from between the folded substrate while the product is shipped and stored, especially in hot or humid environments. A further feature of the preferred embodiment adds a light-tack adhesive to the vibration-coupling surface. This adhesive is used to firmly secure the substrate to a vibrating surface of a vibration-generating device so that the vibrations generated by the device efficiently transmit to the insect-control member. The vibrating substrate serves as a resonating antenna, effectively amplifying the alluring vibratory signal generated by the vibration-generating device to the surrounding air. The light-tack adhesive, when included, helps ensure an intimate contact between the insect-control member and the vibration-generating device for good vibration transfer from one element to the other. Intimate contact between the substrate and a vibrating surface can be achieved in other ways, however, including shaping the insect control member so that it fits snugly over the vibrating surface. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a sectional view of an insect-control member, shown in a folded and storable condition, according to a preferred embodiment of the invention; FIG. 2 is a front plan view of the insect-control member of FIG. 1 , shown in an unfolded, yet unassembled condition; FIGS. 3 a - 3 e are assembly views of the insect-control member, illustrating the process of unfolding, assembling, and mounting to a vibration-generator, the insect-control member of FIG. 1 ; FIG. 4 is a sectional view taken along the line 4 — 4 of FIG. 1 , now showing a second embodiment which includes a perimeter seal arrangement with the device in its folded condition; FIG. 5 is a sectional view taken along the line 5 — 5 of FIG. 2 , now showing the second embodiment in its unfolded condition; FIG. 6 a is a partial sectional view, in detail, of a fastener used to secure the insect-control member in an assembled condition; FIG. 6 b is the partial sectional view of FIG. 6a , now showing the insect-control member in the fastened position; and FIG. 7 is a chart illustrating a generally optimized relationship between flexural modulus and thickness for a variety of materials that can be used as the supporting substrate of the insect control member. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIGS. 1-2 , and 4 - 5 , an insect-control member 10 , according to a preferred embodiment includes a supporting substrate 12 having an insect-engagement surface 14 and a vibration-coupling surface 16 . An appropriate sticky material 18 (described below) is supported across a majority of insect-engagement surface 14 , preferably in a generally uniform thickness. As shown in FIG. 1 , insect-control member 10 can be shipped and stored in a folded manner, folded about a fold-line 20 , so that a portion of the insect-engagement surface 14 is folded upon itself. The fold-line 20 is preferably located along a geometrically symmetrical central axis so that exactly half of the area of insect-engagement surface 14 folds evenly about fold-line 20 into contact with the opposing half of insect-engagement surface 14 . With this folded arrangement, the present insect-control member 10 obviates the need for a release sheet (not shown), and provides a surface 16 (discussed below) that a user can handle without contacting the sticky material. As shown in FIG. 2 , insect-control member 10 preferably includes a peripheral zone 17 . It is preferred that peripheral zone 17 of insect-engagement surface 14 not be coated with sticky material 18 . This helps discourage sticky material 18 from oozing from between the substrate when the device 10 is in its folded and stowed position, as shown in FIG. 1 . It also helps the device to be easily assembled and otherwise handled without contacting sticky surface 18 . Although the present invention may take on any of a variety of shapes, depending on the particular size and shape of the vibration-generator, a preferred shape is frusto-conical (similar to the shape of a lampshade). To achieve this shape, as understood by those skilled in the art, the insect-control member 10 includes an arcuate outside edge 22 , an arcuate inside edge 24 which is generally a concentric arc to outside edge 22 , a first connecting edge 26 and a second connecting edge 28 . When in the folded-orientation, as shown in FIG. 1 , half of the inside edge 24 folds into intimate contact with the remaining half of the inside edge 24 . Similarly, half of the outside edge 22 folds into intimate contact with the remaining half of the outside edge 22 and the first connecting edge 26 generally aligns with the second connecting edge 28 . Appropriate fasteners 30 , such as snaps, hook and loop fasteners (e.g., Velcro-brand fasteners), or sticky tape are positioned adjacent to first and second connecting edges 26 , 28 , respectively. Alternatively, a portion of the sticky material 18 may be used as an appropriate fastener 30 , as described below. Referring to FIGS. 3 a-e , in use, the two halves of the folded insect-control member 10 are pried apart (as shown by arrow 31 in FIGS. 1 and 3 a ), thereby exposing the sticky material 18 , and resulting in a general U-shape structure, as shown in FIGS. 2 and 3 b . The user then arranges the structure so that first connecting edge 26 aligns and overlaps with second connecting edge 28 and the structure forms a 3-dimensional frusto-conical assembly, with the sticky material 18 positioned outwardly. Fasteners 30 are then applied to each other so that the 3-dimensional frusto-conical assembly can maintain its shape, as shown in FIG. 3 c . The sticky material 18 is preferably absent around fasteners 30 in a fastener zone 32 , unless, of course, the sticky material is used to secure first connecting edge 26 to second connecting edge 28 . Once assembled in its frusto-conical shape, insect-control member 10 is positioned onto an output resonating surface 34 which is coupled to a vibration generator 36 (shown in FIG. 3 d and also known as an insect control station) so that the vibration-coupling surface 16 is in flush contact with a portion of the output resonating surface 34 , as shown in FIG. 3 e. Insect-control member 10 preferably increases the effective size of output resonating surface 34 , thereby amplifying the vibratory output signal of vibration generator 36 and extending the effective range of the insect-control member. A suitable vibration generator 36 is described in U.S. application Ser. No. 09/885,216, filed Jun. 20, 2001, entitled “Blood-Sucking Insect Control Station,” now U.S. Pat. No. 6,568,123, issued May 27, 2003, which is hereby incorporated by reference as of set forth in its entirety herein. The vibration generator 36 (therein referred to as an insect control station) includes a sound player and a speaker that transduces a signal into a sound that simulates a heartbeat to attract insects such as mosquitoes and biting flies or to repel them. Only a limited frequency range need be produced by the speaker to simulate the heartbeat. The volume or decibel output of the control station is established so that the target insect or pest can detect the sound and perceive it as a heartbeat so as to be attracted to or repelled from the area of the speaker, as desired. Preferably, the acoustic output of the control station is set at a level that is not readily audible to humans. The effective area (or volume) to which mosquitoes and biting flies are attracted or repelled is at least partially a function of the decibel level output of the speaker. The sticky material 18 can be any of a variety of commercially available insect-alluring and controlling compositions. One preferred material is a pressure sensitive adhesive called “32 UVR” commercially available from Atlantic Paste and Glue, located in Brooklyn, N.Y. This is a UV stabilized pressure sensitive adhesive with adhesion characteristics similar in properties to Atlantic Paste and Glue's “Fly 2+”. The surfactant or sticky material 18 used can include an alluring chemical (such as a sex attractant hormone) and, if necessary, a poison to help lure the insects and quickly kill them once contact is made with the sticky material 18 . The sticky material can be scented with an alluring scent, such as the scent of cherries or peanut butter. The sticky material also can be clear or appropriately colored, such as fluorescent chartreuse, a color that has been shown to attract flying insects. The material properties of the supporting substrate 12 comprise an important aspect of the present invention. We have discovered a relationship between the flexural modulus and the thickness of a material to be used (as measured in a direction normal to the insect-engagement surface 14 ) which permits selection of a suitable material composition for the substrate 12 . Likewise, the relationship we discovered permits a suitable substrate to be specified in terms of thickness when a material composition has already been selected. The relationship permits the substrate to be generally optimally adapted to radiate pressure waves from a vibration generator to which it can be coupled in order to lure or repel insects when placed into service. FIG. 7 illustrates this relationship between flexural modulus and thickness for a variety of materials that can be used as the supporting substrate 12 of the insect control member 10 . While FIG. 7 utilizes flexural modulus as the basis for the selection, other bases can be used, such as tensile strength. The curve traced in FIG. 7 represents a generally optimized relationship between flexural modulus and thickness for polyethylene (PE), polypropylene (PP), polyester (such as polyethylene teraphalate, PET), polycarbonate (PC), polyvinyl chloride (PVC), and Polystyrene (PS). In their unfilled, homopolymer form, these materials have known flexural modulus values as reported, for example, in Plastics Technology, Manufacturing Handbook & Buyers' Guide. For example, the flexural modulus is 10E5 psi for these materials in unfilled, homopolymer form are: Material Flexural Modulus (10E5) PE (low density) 0.2 (high density) 1.2 PP 1.5-2.0 polyester 2.6 PC 3.4 PVC 3.5-4.5 PS 4.5-5.0 If these polymers are filed or blended, the flexural modulus will vary from the data shown in the table above, but in a predictable and known manner. Each of these materials is associated with a natural range of flexural moduli. For example, there is a distribution of molecular weight associated with the material synthesis process, and greater stiffness is attributable to a high molecular weight distribution. Such variations, as well as processing conditions, can require selection of a somewhat thicker or thinner substrate as a function of the variation from standard values that a given sample of material represents. The curve of FIG. 7 , namely, the dashed line, is a guide, however, in the selection of a suitable material for use as the substrate 12 . The curve shows a generally linear relationship between flexural modulus and thickness such that a suitable substrate has a thickness to flexural modulus ratio within a prescribed range of about 1.7×10 −5 to about 2.8×10 −5 mils/PSI. The region above the curve in FIG. 7 represents thicknesses for a given flexural modulus that are more likely to dampen vibrations from the vibration generator 36 . In particular, samples that have a thickness well above the curve for a given flexural modulus, have a dampening effect and progressively reduce the ability to transmit sound wave vibrations suitable for attracting biting insects. On the other hand, the region below the curve represents samples that may not be suitable for use as the substrate 12 because they present potential handling issues. For example, polystyrene is very stiff and so a thin specimen is more likely to snap whereas polyethylene (at the other end of the curve) is so fragile that it is likely to rip if too thin a piece is used. Successful results have been obtained when using polystyrene at 10 mil thickness and when using a low density polyethylene (LDPE) in a 0.5 mil thickness (illustrated as “x” marks in the chart). However, when a material such as a 12 mil thickness polystyrene was used, dampening was observed (see “o” in the chart) Thus, though the thicker sample of polystyrene can function as a substrate, it is not optimum. It should be understood that the curve of FIG. 7 defines a range of thicknesses for a number of materials that can be used, on either side of the line, with optimum results being substantially aligned with points on the curve. By way of comparison, samples that stray from the optimum have shown a dramatically reduced performance in attracting biting insects. The substrate is constructed so as to vibrate at a prescribed frequency that preferably mimics the heartbeat of an animal and is used to lure flying insects to the proximity of the device. A waveform having acoustic energy in the range of 20 to 500 cps is generally desired. Evidence suggests that mosquitoes will be attracted to acoustic signals in the range of from 50 cps to 120 cps, and will be strongly attracted to its acoustic signals in the range of from about 150 cps to about 350 cps. Applicants presently believe that one or more frequencies in the range of 150 cps to 250 cps together with one or more frequencies in the range of peak in the 300 cps to 500 cps range comprise the best signal for attracting mosquitoes. Discrete “ejection sounds” or clicks associated with a damaged heart have a frequency in the 160 to 180 cps range, and these clicks also be a reason that mosquito are particularly attracted individuals with damaged hearts. A waveform can be constructed to have a primary peak in the 150 cps to 250 cps range and a secondary peak in the 300 cps to 500 cps range. A suitable waveform can include frequency components in these ranges alone, or so that the frequency components in these two peaks dominate other frequencies in the waveform. The medical profession, and particularly cardiologists, have recognized that the acoustic signals from a heartbeat are not simply the “lub-dub” sounds familiar to lay individuals. More particularly, medical specialists have recognized the significance of the cadence, rhythm, and relationship between particular components of the heart sound, which are medically referred to as the S1, S2, S3, and S4 components of the heartbeat. While each of these component sounds in turn can have fluctuations functionally dependent upon the respiratory cycle of the individual, the characteristic frequency of these components is not significantly affected by this respiratory cycle. During both inspiration and expiration, the characteristic frequency of the S1 and S2 components for a healthy heart is normally in the range of from 110 cps to 120 cps, while the characteristic frequency of the S3 component is in the range of from 70 cps to 90 cps. The S4 component can be inaudible to humans using a normal stethoscope for a patient less than 50 years old, although there is no reason to believe that the S4 component, which is generally in the range of 50 cps to 70 cps, is not detected by mosquitoes. As indicated above, evidence has shown that mosquitoes are strongly attracted to individuals with a damaged heartbeat, and the medical profession has studied in depth the timing, configuration, and duration of heart murmurs. While certain murmurs have a relatively low frequency in the range of from 60 cps to 100 cps, heart murmurs more often are in the medium-frequency range of from 100 cps to 250 cps, or are in the higher frequency range of more than 300 cps associated with “blowing.” Referring now to FIGS. 4 and 5 and according to another embodiment of the invention, as described above, insect-control member 10 is coated on insect-engagement surface 16 except within peripheral zone 17 . To further prevent sticky material from leaking out from between the folded substrate, a seal 42 is provided along the perimeter of device 10 , within peripheral zone 17 . Seal 42 can be made from any appropriate adhesive that is sufficient to effectively stem the flow of sticky material 18 from reaching the margins 22 - 28 . Seal 42 is particularly beneficial if the sticky material selected becomes fluid-like under the influence of gravity and/or when stored in a hot or humid environment. Seal 42 is preferably made from a pressure-sensitive, medium-tack adhesive so that it may be relatively easily separated by a user when the device 10 is unfolded. As shown in FIG. 4 , seal 42 is sized and shaped to align with and adhere to itself when device 10 is folded. When the substrate is unfolded, as shown in FIG. 5 , seal 42 becomes exposed and may even aid in capturing some flying insects if contact is made or serve as a fastener 30 . Referring now to FIGS. 6 a - 6 b , one embodiment of the fastener 30 comprises complimentary protuberances and apertures. These can be formed by conventional stamping and hole punching techniques, as known in the art. For example, stamping the substrate 10 can cause a protuberance to form which has a bulbous end and a necked-down extension extending from the substrate. The bulbous portion snap-locks into a punched aperture. Other arrangements for the fastener are within the spirit of the present invention, such as the sticky surface 18 or the perimeter seal 42 . In service, the insect-control member 10 is disposed upon an insect control station, and preferably an insect control station having a vibration generator 36 . After a period of time, the proper vibration attracts insects to the proximity of the device. Other cues, e.g., carbon dioxide, heat, and/or chemical lures, cause orientation and landing on member 10 to which they preferably become affixed by action of a glue. Alternatively, the insect-control member 10 can include an oil-based composition (e.g., a composition including a mineral oil base) that is adapted to adhere to a contacting insect and be carried off by said insect for reaction with said insect at a remote location, e.g., due to reflow. While an illustrative embodiment of the invention has been described, various modifications will be apparent to those of ordinary skill in the art. Such modifications are within the spirit and scope of our invention, which is limited and defined only by the appended claims.

1a

CLAIM OF PRIORITY This application claims the priority of U.S. Ser. No. 61/787,786 filed on Mar. 15, 2013, the contents of which are fully incorporated herein by reference. FIELD OF THE INVENTION The invention relates to toy for the amusement or exercise of an animal, and more particularly to a laser toy for remotely viewing and playing with a pet and a smartphone app to facilitate interaction. BACKGROUND OF THE INVENTION Pets, especially indoor cats, require frequent play for both their physical and emotional well-being. A working owner of such an indoor pet may be restricted in the time available for playing in-person and may, therefore, want to play with their pet while at work or otherwise distant from the animal. Laser pointers are a well-known way of engaging with pets, many of whom play tirelessly chasing the red dot that forms when a laser beam makes contact with a surface. By combining a remotely movable laser pointer with a remote camera, a pet owner may play with their pet remotely while seeing and hearing their pet. The use of automated sequences of play may also allow the owner to watch their pet playing while they are otherwise occupied. REVIEW OF RELATED TECHNOLOGY U.S. Pat. No. 7,066,780 issued to Jamison on Jun. 27, 2006 entitled “Pet entertainment device” describes a pet entertainment device for the entertainment of a pet. The device has a laser device that is configured to attach to a pet though use of a garment, such as a collar. The laser device is preferably controllable through use of a remote control so that the movement of the pet (dog, cat, etc.) can be directed by the pet's owner. U.S. Pat. No. 6,651,591 issued to Chelen on Nov. 25, 2003 entitled “Automatic laser pet toy and exerciser” describes a pet toy and exerciser which produces an automatically movable, outwardly projected laser beam. The function thereof is to provide virtual “prey” for the stimulation and exercise of an animal. The device, which does not include a conventional motor, is small (e.g., can be handheld), lightweight, battery operated and silent, and has an extremely long potential cycle life. Electrically energized nitinol wires deflect a visible laser module to produce a virtual laser light target moved through three dimensions. US Patent Application 2012/0298049 issued to A. Cook et al. on Nov. 29, 2012 entitled “Light Projecting Pet Toy” describes a laser pet toy including a light source with a focused beam of light of a predetermined shape and programmable random travel across an opaque surface such as a floor or wall to create an engaging image for a pet to play with the image for entertainment or exercise. U.S. Pat. No. 8,347,823 issued to Thomas et al. on Jan. 8, 2013 entitled “Pet triggered programmable toy” that describes a pet toy having a control module, active triggering module, and passive triggering module. The device is an interface between a pet and pet toy or other useful device. A pet can trigger at will a moving highly collimated light dot for exercise, entertainment, mental stimulation, education, and even surrogate companionship in the absence of a human caretaker. Pets that fail to learn triggering behavior will benefit from pre-set play periods as programmed or selected by their caretaker and/or passive activation such as infrared detection or another proximity sensing switch. Various implementations are known in the art, but fail to address all of the problems solved by the invention described herein. Embodiments of this invention are illustrated in the accompanying drawings and will be described in more detail herein below. SUMMARY OF THE INVENTION An inventive toy and web and/or mobile application (“app”) for remotely viewing and playing with a pet is disclosed. The toy may include both a remotely controlled light pointer and a remote camera so that a user may, in real time, maneuver a spot of light on a remote surface while watching their pet chase the moving spot of light. An app may allow a smartphone to be used to facilitate the interaction. In a preferred embodiment, a digital processor may be functionally connected to a viewing screen on which a controlled cursor may be displayed. A user may be able to move the cursor in both a horizontal and vertical direction, and in so doing, may control the direction in which a remotely controlled light beam is pointing. At the same time, the viewing screen may display images from a camera located along with the controlled light source to observe the motion of the light beam and the activities of a pet that may be chasing the spot caused by the light source when it intersects with a surface. In a preferred embodiment, the light source may be a laser or a focused light emitting diode (LED) that may be mounted on an electronically movable platform. The viewing screen and user may be in one location, while the camera and the movable light source may be in a second location, remote from the first. Signals may be sent to and from the digital processer, the camera, and the electronically movable platform carrying the light source by connections such as, but not limited to, a direct physical link, a wireless link mediated by transceivers connected to each location, a link over a public digital network, or some combination thereof. The controlled cursor may be displayed on the viewing screen in a control cursor window and may be moved by user interactions such as, but not limited to, motion on a touch screen, using a mouse, using buttons on a real or virtual computer keyboard, a real or virtual five way controller or some combination thereof. The processor may also contain one or more predefined predetermined patterns of motion of the cursor and, therefore, of the spot caused by the laser beam. These predetermined patterns may be recorded from actual play and may be made to run in a continuous loop mode. In a further preferred embodiment of the invention, the camera may also be mounted on an electronically controlled platform and may be moved in pan, zoom, and tilt by the remote operator using a device such as, but not limited to, a real or virtual five way controller, a mouse controlled cursor, a touch controlled cursor, one or more keys of a real or virtual computer keyboard or some combination thereof. The images supplied by the camera to the viewing screen may be a sequence of still images, or a video steam, including, but not limited to compressed high definition video. In a further preferred embodiment of the invention, the viewing screen may be part of a smartphone. Similarly, the camera may be part of a second smartphone. In addition to a camera, the remote site may include a microphone that may relay sounds in both directions. Therefore, the present invention succeeds in conferring the following, and others not mentioned, desirable and useful benefits and objectives. It is an object of the present invention to provide a toy for playing remotely with a pet. It is another object of the present invention to provide a way to see and hear the pet playing remotely. Yet another object of the present invention is to provide an interactive way of playing with the pet. Still another object of the present invention is to provide an inexpensive yet effective toy for remote playing and watching a pet. Still another object of the present invention is to a way to automate some or all of the effort in playing remotely with a pet. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a schematic overview of a preferred embodiment of an app and it's functionality for remotely viewing and playing with a pet using a toy of the present invention. FIG. 2 shows a schematic overview of an app enabled control portion of a system for remotely viewing and playing with a pet of the present invention. FIG. 3 shows a schematic overview of an app controlled camera and light source of a further preferred embodiment of the present invention. FIG. 4 shows a schematic flow diagram of an app of the present invention. FIG. 5 shows an apparatus that interacts with the app and enables remotely viewing and interacting with a pet. DESCRIPTION OF THE PREFERRED EMBODIMENTS The preferred embodiments of the present invention will now be described with reference to the drawings. Identical elements in the various figures are identified with the same reference numerals. Various embodiments of the present invention are described in detail. Such embodiments are provided by way of explanation of the present invention, which is not intended to be limited thereto. In fact, those of ordinary skill in the art may appreciate upon reading the present specification and viewing the present drawings that various modifications and variations can be made thereto. FIG. 1 shows a schematic overview of a preferred embodiment of an computer implemented program or app and it's functionality for remotely viewing and playing with a pet using a toy of the present invention. A user 115 may be located in a first location 160 , along with a viewing screen 110 that may be attached to a digital processor 105 . The user may be in communication with a camera 120 and a light source 130 that may be located in a second location 165 that may be remote from the first location 160 . An app operable on the digital processor 105 may allow the user 115 to play with a pet 140 that may also be located in the second location 165 . The app may, for instance, allow the user to remotely control a light source 130 that may be pointed in a particular direction 145 . At the point where the beam of light 125 emitted by the light source 130 intersects a solid surface, a spot 146 will appear. By altering the direction of the beam of light 125 , the user may cause the spot to move around and may, therefore, entice a pet 140 to play or exercise. The user may observe the pet at play via images from the camera 120 that may be relayed by the app to the viewing screen 110 located proximate to the user 115 . The light source 130 may be any suitably collimated light source. In a preferred embodiment, the light source 130 may be a diode or solid state laser, or a suitably focused light emitting diode (LED). In a preferred embodiment, the digital processor 105 and the viewing screen 110 may both be part of the same smartphone on which the app is operable. A first transceiver 150 that may be part of the same smartphone may wirelessly connect the smartphone to the light source 130 and the camera 120 via a public digital network 170 and a second transceiver 155 . In further embodiments, the transceivers may instead use a short range protocol such as, but not limited to, a Wi-Fi wireless communications protocol. The light source 130 may, for instance, be mounted on a electronically movable platform 135 . In a preferred embodiment, the electronically movable platform 135 may use DC motors to alter the direction in which the beam of light 125 is pointed. The electronically movable platform 135 , the light source 130 and the camera 120 may each or all be powered by batteries, rechargeable batteries, a power source connected to the mains or some combination thereof. In a further preferred embodiment of the invention, there may be a sound emitting device 180 located proximate to the light source. The sound emitting device may, for instance, be used to emit a sound that attracts the pets. Cats, for instance, are easily attracted to high frequency noises that may sound like scratching or high pitched squeaking. By producing such a sound for a brief period when the light source is first turned on, the pet may be conditioned, or trained, to associate the noise with playing with the light beam and may thereby be called to play. In a preferred embodiment the camera 120 may be both a still and a video camera, and may incorporate a microphone 175 so that the sounds of the pet playing may also be heard by the user. The app may also facilitate recording of the still and video images. The recording may, for instance, occur either at the camera 120 or at the digital processor 105 . In order to save memory, the video recording may be suitably compressed using standards such as, but not limited to, MPEG compression that is well-known in the art. The recorded video may also or instead be captured at either the device attached to the camera 120 , or by the device attached to the viewing screen 110 . Either of these devices may, for instance, be a smartphone and may be equipped to upload the video directly to the Internet, either for viewing as a streaming video or for being stored on, for instance, a cloud based memory device. In a further preferred embodiment of the invention, there may also be a treat dispensing mechanism 185 located at the second location 165 . The treat dispensing mechanism 185 may, for instance, be similar to a well-known PEZ® dispenser. It may be loaded with pet treats that the user 115 may elect to dispense using a control signal. FIG. 2 shows a schematic overview of an app enabled control portion of an system for remotely viewing and playing with a pet of the present invention. As shown in FIG. 2 , an app operable on a digital processor 105 may mediate user interactions in order to control the light source and the camera in the remote location. In a preferred embodiment, a user may be able to see a viewing screen 110 that may be controlled by the app of this invention running on a digital processor 105 . The viewing screen 110 may, for instance, display a video images 210 taken in the remote location and showing the pet playing with the spot 146 . In one embodiment of the invention the user may access a computer mouse 230 on a mouse-pad 245 . Movement of the mouse on the mouse-pad may, for instance, be relayed via the digital processor 105 to control the position of a controlled cursor 205 that may be displayed in a control cursor window 250 . The position of the cursor, or the control signals associated with positioning the cursor, may also be relayed to the electronically movable platform 135 on which the light source 130 is mounted so that the motion of the light source and hence the motion of the spot 146 is effectively controlled by the position of the cursor (see FIG. 1 ). In a further preferred embodiment of the invention, the computer mouse 230 may directly control the position of the spot in the image 210 and hence effectively control the motion of the light source and the actual spot. Either of these interactions may instead be accomplished using a touch screen. If viewing screen 110 includes an overlaid touch sensitive screen, then a user may move the cursor 205 horizontally or vertically within the control cursor window 250 in order to control the motion of the light source and hence the motion of the spot 146 . In a touch screen implementation, a user may interact directly with video and may effectively move the spot using their finger. In a further preferred embodiment of the invention, the user may interact with the digital processor 105 using a keyboard or keypad. The computer keyboard 235 may be a physical or a virtual keyboard containing physical or virtual keyboard buttons 240 . By selecting a particular keyboard buttons 240 , the user may initiate a predetermined pattern of movement of the spot such as, but not limited to, the predetermined pattern of motion 225 shown. The predetermined pattern may also be combined with the RFID detector and RFID tag so as not to point the laser at or close to the pet. Knowing where the RFID tag may be located, and hence where the pet's head may be located or near, may allow the laser, or light beam, to automatically interact with the pet by always pointing a specified distance away from the pet. The user may also record patterns of play for future use. The user may also control the motion of the camera if the camera is also mounted on a moveable mount. The user may, for instance, interact with a position control device 215 such as, but not limited to, a five way device, that may control the pan, zoom and tilt of the camera. The user may also use a combination microphone and speaker 220 to hear noises at the remote location and also to provide sound at the remote location. FIG. 3 shows a schematic overview of an app controlled camera and light source of a further preferred embodiment of the present invention. In addition to the light source 130 being mounted on an electronically movable platform 135 , the camera 120 may also be mounted on a second electronically movable platform 305 . Alternatively, the camera 120 and the light source 130 may be positioned on the same platform. The platforms may have a connection 310 between the first and second electronically movable platforms or they may be mounted separately. Both platforms may be controllable by one or more servo motors 320 or other similar devices. The camera 120 may also include a remotely controlled camera lens 315 and a speaker/microphone 220 . FIG. 4 shows a schematic flow diagram of an app of the present invention. In Step 401 , the user may activate the remote camera. This may, for instance, be accomplished using keypad buttons or by selecting icons on a touch screen. Activating the remote camera may include functions such as, but not limited to, accessing the remote camera wirelessly either over a telephone network, a data network, a local Wi-Fi network or some combination thereof. In Step 402 the user may be queried as to whether they want to have the noise on. The noise may, for instance, be a noise designed to attract the pet to the light source. For instance, cats may be attracted to high pitched scratching type noises. By selecting to go to Step 408 and activate such a noise, or sound, for a short time when the light source is first turned on, the pet may be conditioned to associate the sound with the play and may therefore come to the light source from where ever they happen to be. The noise may, for instance, be activated for a time between 1 and 20 seconds. In Step 403 the user may be queried as to whether they want to record the video. If the user elects to go to Step 409 and activate the video recording, the recorded video may be stored either at the camera or the processor, or some combination thereof. When the processor is part of a smartphone, the video may instead be relayed to a third party and stored there. In Step 404 the user may be queried as to whether they want to have the light source controlled freestyle, i.e., if they want to control the motion of the light source and hence of the spot. If they elect not to, they may, at Step 410 , be invited to select an automatic mode. This may be a standard premade program of movement or it may be a program of movement recorded from a previous freestyle mode of interacting. The selection may be made by, for instance, selecting an option such as, but not limited to, an icon, a drop down menu, a particular hard or soft keypad or keyboard button, or some combination thereof. In Step 405 , the light source may be activated, and remote playing with the pet may commence. At a point during playing, the app may query the user as to whether they would like to reward the pet. If the user elects to activate the reward dispenser, one of whatever treats have been pre-stored in the dispenser may be dispensed. The treats may be useful in reinforcing the pets play or exercise behavior. When the user desired to stop interacting with the device remotely, the user may go to Step 407 and end the remote playing session. One of ordinary skill in the art will appreciate that the inventive method described above may be operating system agnostic, i.e., it may be implemented using any reasonable operating system or computing environment including, but not limited to, the Android, iOS system, and Windows system, or the like. One of ordinary skill in the art will further appreciate that the camera, light source and other hardware described above are readily available commercially in a variety of devices. Any reasonable device containing the functionality described above may be incorporated to implement the inventive methods described above including, but not limited to, camera equipped mobile phones, smartphones, iPads, tablets, lap top computers, desktop computers, or some combination thereof. In FIG. 5 , there is a representation of an embodiment of the present invention that may be used with the application as described above. The apparatus 500 can be used to interact with and monitor living things, preferably pets, from a remote location. The apparatus 500 generally has a housing 520 . The housing 520 may have a first half 515 and a second half 525 , as well as a base 510 and a top 595 . The base 510 may be comprised of a non-slip surface or may have parts that operate as a non-slip surface. In some embodiments, the base 510 may have a flip down member that can be used to assist in securing the position of the apparatus 500 . In one part of the housing 500 , there is a window 550 . The window 550 is preferably a transparent and/or translucent plastic and has shatter resistant properties. Additionally, the material of the window 550 should be selected to have minimal interference with optical devices such as cameras or lights. In the windowed section of the housing 520 , there is a mounting mechanism 590 . There is at least one servo motor 580 operably connected to the mounting mechanism which enables rotational movement of the mounting mechanism 590 . The mounting mechanism 590 may have motion through at least one, and preferably, two or three axes of motion. There may need to be a servo motor 580 included for each independent axis of motion. The mounting mechanism 590 holds and secures a light source 560 and an optical device 570 . The light source 560 may be a diode or solid state laser or a suitably focused light emitting diode, but is preferably a laser. The light source 560 is positioned in a way that the movement of the mounting mechanism 590 , in turn moves the direction of the emitted light. The optical device 570 is preferably a camera. The camera may have recording capabilities and could capture sounds emitted within a proximity of the apparatus 500 . The optical device 570 is positioned so that the lens or other image capture mechanism is always directed in the direction of and towards the light emitted from the light source 560 . As previously described, a user can interact with the apparatus 500 from a remote location. This enables the user to interact with a pet when said user is out of the house for days at a time or only for a short time. The user manipulates the direction of the optical device 570 and the light source 560 via an electronic device such as a smartphone. The smartphone enables the user to manipulate the direction of the optical device 570 and light source 560 in real time. If the user so desires, the may be able to send an electrical signal to the apparatus 500 that activates a dispensing mechanism 530 . The dispensing mechanism 530 is designed to dispense a number of items including toys, food, treats, and the like. Once selected, the dispensing mechanism 530 activates and the desired item is moved from it storage position to the dispensing outlet 540 located in the housing 520 . The dispensing mechanism 530 may hinge, as shown, to enable the various toys, food, etc. to be positioned and stored within the apparatus 500 for dispensing. Further interaction may comprise such actions as described above and other not disclosed actions that are within the spirit of this invention. The apparatus 500 may comprise varying materials including but not limited to plastics, metals, glass, resins, composites, and the like. Preferably the housing 520 is of sufficient light weight that it will not cause injury and is cost effective. Preferably plastics are used which may include polyethylene terephthalate (PET), polyethylene (PE), high-density polyethylene, polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), low-density polyethylene (LDPE), polypropylene (PP), polystyrene (PS), high impact polystyrene (HIPS) and polycarbonate (PC), or any combination thereof. Composites, when used, may include but are not limited to fiber reinforced plastics, metal composites, carbon fiber, and Kevlar® and the like. Metals may comprise lightweight metals such as aluminum and other pure metals as well as various alloys. Such aforementioned materials may comprise any of the other parts of the invention including the window 550 , dispensing mechanism 530 , mounting mechanism 590 , and the other various components. The apparatus 500 may be wired and plug into any standard outlet or may operate off battery power. In some instances, photovoltaic cells may be used to power the apparatus 500 . Although this invention has been described with a certain degree of particularity, it is to be understood that the present disclosure has been made only by way of illustration and that numerous changes in the details of construction and arrangement of parts may be resorted to without departing from the spirit and the scope of the invention.

1a

[0001] This is a Continuation of application Ser. No. 10/464,778, filed Jun. 19, 2003, which claims the benefit of U.S. Provisional Application No. 60/402,555, filed Aug. 12, 2002. The disclosure of the prior applications is hereby incorporated by reference herein in its entirety. FIELD OF THE INVENTION [0002] This invention relates to an electrosurgical system, and in particular to one in which an electrosurgical generator provides a radio frequency cutting signal to a bipolar surgical instrument. BACKGROUND OF THE INVENTION [0003] A typical bipolar cutting instrument, which may also be capable of tissue coagulation, comprises first and second electrodes separated by an insulating spacer. An early example of a bipolar RF cutting device is U.S. Pat. No. 4,706,667 issued to Roos, in which the return or “neutral” electrode is set back from the active electrode. In a series of patents (including U.S. Pat. Nos. 4,674,498, 4,850,353, 4,862,890 and U.S. Pat. No. 4,958,539) Stasz proposed a variety of cutting blade designs. These were designed with relatively small gaps between two electrodes such that arcing would occur therebetween when an RF signal was applied to the blade, the arcing causing the cutting of the tissue. In an alternative arrangement, described in our co-pending patent applications GB 0130975.6 and U.S. Ser. No. 10/105,811, a device is provided in which the spacing of the electrodes is designed such that direct arcing between the electrodes does not occur, but arcing does occur between one of the electrodes and the tissue at the target site. [0004] Normal use of this instrument has proved very satisfactory, but in exceptional circumstances (especially where the instrument has been used in an overly aggressive manner) a situation hereinafter referred to as a “flare-out” may develop. It is not uncommon for small particles of condensed tissue and other debris to become attached to the electrodes, and ordinarily this poses no particular problem. However in the case of a flare-out, the debris forms a conductive track between the electrodes, allowing current to flow directly therebetween. This low impedance electrical pathway from one electrode to the other, if allowed to continue for a period of several seconds, may conduct sufficient current that a failure of the device may occur. This may be by way of a failure of the insulating material forming the spacer, either by the insulating material experiencing such high temperatures that it becomes conductive, or by the temperature differentials throughout the insulator causing a physical cracking of the material. Alternatively, the extreme temperatures caused by the current flow may produce a physical melting of the electrode material itself. SUMMARY OF THE INVENTION [0005] The present invention provides a way in which this condition, although rarely occurring, can be prevented from causing a failure of the device. Accordingly, there is provided an electrosurgical system including a radio frequency generator, an electrosurgical instrument comprising at least first and second electrodes and an insulating spacer separating the first and second electrodes, the radio frequency generator being adapted to supply a radio frequency signal between the first and second electrodes, means for measuring a characteristic of the output of the radio frequency generator, and a controller adapted to analyse the measured characteristic and change the radio frequency signal supplied between the first and second electrodes when an aspect of the characteristic meets a predetermined criterion indicating the onset of a “flare-out”. [0006] Conveniently, the characteristic of the output of the radio frequency generator which is measured is the voltage across the first and second electrodes, or alternatively the current flowing therebetween. It has been discovered that there are a number of criteria which may indicate the onset of a flare-out. These include rapid changes in the impedance experienced between the electrodes, leading to large and sudden changes in the voltage between the electrodes or the current flowing therebetween. There may be an increase in the number or amplitude of high frequency components of the current or voltage signal, or an increase in the D.C. thermionic current sensed between the electrodes. In a preferred arrangement, the predetermined criterion indicating the onset of a flare-out is the changeability of the measured characteristic, typically the rate of change of the impedance between the electrodes, or the changeability as represented by the sum of the differences between successive impedance measurements. [0007] Preferably, the controller is adapted to change the radio frequency signal by reducing the power thereof when the predetermined criteria indicating the onset of a flare-out is met. Alternatively, the controller may reduce the voltage of the radio frequency signal, or even the frequency thereof. Where the radio frequency signal comprises a signal having dual components at a first and second frequency, the controller may change the signal by adjusting the relative proportions of the first and second frequency components. Preferably, however, the controller is adapted to reduce the power of the radio frequency signal, and may reduce it substantially to zero when the characteristic meets the predetermined criterion. Conveniently, the power is reduced substantially to zero for a period of at least 5 seconds, allowing time for the instrument to be withdrawn from the surgical site and the electrodes to be cleaned if necessary. Alternatively the power is reduced to zero until the operator of the instrument manually resets the instrument. [0008] In one convenient arrangement, the controller is adapted to reduce the power of the radio frequency signal supplied between the first and second electrodes only when the aspect of the characteristic meets the predetermined criterion for a predetermined period of time. This serves to ensure that a false detection of a flare-out is not triggered by a transient change in the measured characteristic. The system may require a series of repeated measurements of the characteristic to all fit the predetermined criteria before action is taken. [0009] Although potentially of use with other types of instrument, the present invention is primarily designed to be employed with instruments in which the first and second electrodes and the insulating spacer are such that the spacing between the electrodes is between 0.25 mm and 3.0 mm. [0010] According to one preferred construction, an electrosurgical system includes a radio frequency generator, an electrosurgical instrument comprising at least first and second electrodes and an insulating spacer separating the first and second electrodes, the radio frequency generator being adapted to supply a radio frequency signal between the first and second electrodes, means for measuring the impedance between the first and second electrodes, and a controller adapted to analyse the impedance measurements and interrupt the radio frequency signal supplied between the first and second electrodes when the changeability of the impedance exceeds a predetermined threshold value. [0011] The invention further resides in an electrosurgical generator for supplying radio frequency power to an electrosurgical instrument which includes at least first and second electrodes, the radio frequency generator including a radio frequency output stage having at least a pair of RF output lines for connection to the first and second electrodes respectively, a power supply coupled to the output stage for supplying power to the output stage, and a controller capable of varying the RF signal applied to the RF output lines, wherein there is provided means for measuring a characteristic of the radio frequency signal across the output lines, the controller being adapted to analyse the measured characteristic and change the radio frequency signal supplied to the output stage when an aspect of the characteristic meets a predetermined criterion indicating the onset of a “flare-out”. [0012] More specifically, the present invention relates to an electrosurgical generator for supplying radio frequency power to an electrosurgical instrument which includes at least first and second electrodes, the radio frequency generator including a radio frequency output stage having at least a pair of RF output lines for connection to the first and second electrodes respectively, a power supply coupled to the output stage for supplying power to the output stage, and a controller capable of varying the RF signal applied to the RF output lines, wherein there is provided means for measuring the impedance across the output lines, the controller being adapted to analyse the impedance measurements and interrupt the radio frequency signal supplied to the output stage when the changeability of the impedance exceeds a predetermined threshold value. [0013] Finally, the present invention extends to a method of cutting tissue at a target site comprising providing a bipolar cutting blade comprising first and second electrodes and an electrical insulator spacing apart the electrodes, bringing the blade into position with respect to the target site such that one electrode is in contact with tissue at the target site and the other is adjacent thereto, supplying an electrosurgical voltage to the cutting blade such that arcing does not occur in air between the first and second electrodes but that arcing does occur between one of the electrodes and the tissue at the target site, measuring the impedance between the first and second electrodes, and interrupting the electrosurgical voltage when the changeability of the impedance exceeds a predetermined threshold value. [0014] The present invention will now be further described below, by way of example only, with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0015] In the drawings: [0016] FIG. 1 is a schematic diagram of an electrosurgical system in accordance with the present invention; [0017] FIG. 2 is a schematic side view of an electrosurgical instrument suitable for use in the system of FIG. 1 , [0018] FIG. 3 is a schematic block diagram of the generator of the system of FIG. 1 , and [0019] FIGS. 4 and 5 are schematic representations of the impedance measured across the electrodes of the system of FIG. 1 , in normal operation and in the event of a flare-out, respectively. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0020] Referring to FIG. 1 , a generator 10 has an output socket 10 S providing a radio frequency (RF) output for an instrument 12 via a connection cord 14 . Activation of the generator may be performed from the instrument 12 via a connection in cord 14 or by means of a footswitch unit 16 , as shown, connected to the rear of the generator by a footswitch connection cord 18 . In the illustrated embodiment footswitch unit 16 has two footswitches 16 A and 16 B for selecting a coagulation mode and a cutting mode of the generator respectively. The generator front panel has push buttons 20 and 22 for respectively setting coagulation and cutting power levels, which are indicated in a display 24 . Push buttons 26 are provided as an alternative means for selection between coagulation and cutting modes. [0021] Referring to FIG. 2 , the instrument 12 comprises a blade shown generally at 1 and including a generally flat first electrode 2 , a larger second electrode 3 and an electrical insulator 4 separating the first and second electrodes. The first electrode 2 is formed of stainless steel while the second electrode 3 is formed from copper integrally with a body portion 9 . The surface of the second electrode is plated with a biocompatible material such as stainless steel, or alternatively with a non-oxidising material such as gold, platinum or palladium. The electrical insulator 4 is formed from a ceramic material such as Al 2 O 3 . A conductive lead 5 is connected to the first electrode 2 , while lead 6 is connected to the second electrode 3 . The RF output from the generator 10 is connected to the blade 1 via the leads 5 and 6 so that a radio frequency signal having a substantially constant peak voltage (typically around 400V) appears between the first and second electrodes. When the blade 1 is brought into contact with tissue at a target site, the RF voltage will cause arcing between one of the electrodes and the tissue surface. Because the first electrode 2 is smaller in cross-sectional area, and has a lower thermal capacity and conductivity than that of the second electrode 3 , the first electrode will assume the role of the active electrode and arcing will occur from this electrode to the tissue. Electrical current will flow through the tissue to the second electrode 3 , which will assume the role of the return electrode. Cutting of the tissue will occur at the active electrode, and the blade may be moved through the tissue. [0022] Referring to FIG. 3 , the generator comprises a radio frequency (RF) power oscillator 60 having a pair of output lines 60 C for coupling via output terminals 62 to the load impedance 64 represented by the instrument 12 when in use. Power is supplied to the oscillator 60 by a switched mode power supply 66 . [0023] In the preferred embodiment, the RF oscillator 60 operates at about 400 kHz, with any frequency from 300 kHz upwards into the HF range being feasible. The switched mode power supply typically operates at a frequency in the range of from 25 to 50 kHz. Coupled across the output lines 60 C is a voltage threshold detector 68 having a first output 68 A coupled to the switched mode power supply 16 and a second output 68 B coupled to an “on” time control circuit 70 . A micro-processor controller 72 coupled to the operator controls and display (shown in FIG. 1 ) is connected to a control input 66 A of the power supply 66 for adjusting the generator output power by supply voltage variation and to a threshold-set input 68 C of the voltage threshold detector 68 for setting peak RF output voltage limits. Also coupled across the output lines 60 C is a current detection circuit 80 which feeds signals to the controller 72 via line 81 . [0024] In operation, the microprocessor controller 72 causes power to be applied to the switched mode power supply 66 when electrosurgical power is demanded by the surgeon operating an activation switch arrangement which may be provided on a hand-piece or footswitch (see FIG. 1 ). A constant output voltage threshold is set independently on the supply voltage via input 68 C according to control settings on the front panel of the generator (see FIG. 1 ). Typically, for desiccation or coagulation the threshold is set at a desiccation threshold value between 150 volts and 200 volts. When a cutting or vaporisation output is required the threshold is set to a value in the range of from 250 or 300 volts to 600 volts. These voltage values are peak values. Their being peak values means that for desiccation at least it is preferable to have an output RF wave-form of low crest factor to give maximum power before the voltage is clamped at the values given. Typically a crest factor of 1.5 or less is achieved. [0025] When the generator is first activated, the status of the control input 60 I of the RF oscillator 60 (which is connected to the “on” time control circuit 70 ) is “on”, such that the power switching device which forms the oscillating element of the oscillator 60 is switched on for a maximum conduction period during each oscillation cycle. The power delivered to the load 64 depends partly on the supply voltage applied to the RF oscillator 60 from the switched mode power supply 66 and partly on the load impedance 64 . The voltage threshold for a desiccation output is set to cause trigger signals to be sent to the “on” time control circuit 70 and to the switched mode power supply 66 when the voltage threshold is reached. The “on” time control circuit 70 has the effect of virtually instantaneously reducing the “on” time of the RF oscillator-switching device. Simultaneously, the switched mode power supply is disabled so that the voltage supplied to oscillator 60 begins to fall. The operation of the generator in this way is described in detail in our European Patent Application No. 0754437, the disclosure of which is hereby incorporated by way of reference. [0026] Referring back to FIG. 2 , when the instrument 12 is in use, small particles of condensed tissue and other debris can become adhered to the edge electrode 2 and, to a lesser extent, the base electrode 3 . If the instrument is used particularly aggressively, it is possible that a conductive track of such debris can build up between the electrodes 2 and 3 across the ceramic insulator 4 . Such a conductive track is shown schematically at 11 in FIG. 2 . If no action is taken to prevent it, this conductive track 11 will develop into a “flare-out” in which the current passing directly between the electrode 2 and the electrode 3 will cause the instrument to overheat and finally fail. The following description explains how the generator 10 detects and compensates for just such a situation. [0027] At regular intervals, in this case every 10 ms the current is measured across the load 64 by the current detector 80 and the current value is sent to the controller 72 . The controller uses the current value to determine repeatedly the impedance across the load 64 . The difference between successive impedance values, irrespective of their absolute value, is calculated, and summed for 16 consecutive readings to give a first total Z 1 . The current measurements continue every 10 ms until a further 16 consecutive impedance calculations have been made, which calculations are again summed to give a second total Z 2 . If Z 1 and Z 2 are both less than the threshold criteria for the sum Q of the impedance changes, then the generator continues to supply RF signals to the instrument 12 . The process is continued with further current measurements being sent to the controller 72 every 10 ms. This normal operation is shown in FIG. 4 , in which the voltage across the electrodes 2 , 3 is shown by trace 31 , the current flowing by trace 32 and the impedance measured by the generator by trace 33 . [0028] If a flare-out starts to develop between the electrodes 2 and 3 , the current measured across the load 64 will start to fluctuate widely, and with a high frequency of oscillation. This is shown in FIG. 5 , with the build up to the flare-out being shown at 34 and the onset of the flare-out at 35 . In these circumstances Z 1 and Z 2 (representing difference in impedance values, not absolute impedance values) will both be above the threshold for the sum Q of the impedance changes, and this causes the controller to send a signal to the power supply 66 to cause the power to be interrupted. A typical value for Q is 1000 ohms, for a 16 measurement cycle. [0029] In addition to interrupting the power supply, the controller may cause a message (such as “Clean Tip”) to be displayed by the display 24 . The controller does not allow power to be restored to the output of the generator until the surgeon has pressed a reset button to indicate that the tip has been cleaned, and will repeat the interruption process if the impedance measurements show that the flare-out conditions are still in existence when the power is recommenced. [0030] It will be appreciated that criteria other than the changeability of the impedance across the output of the generator could be employed to give an indication of the onset of a flare-out. These include, non-exhaustively, the high frequency content (e.g. the number of high frequency components) of the modulation of the current or voltage signal, or the D.C. thermionic current flowing between the electrodes 2 and 3 . The latter will be measured in the manner disclosed in U.S. Pat. No. 6,547,786, the contents of which are incorporated herein by reference. [0031] It will also be appreciated that, while the embodiments of the invention have been described with reference to the elimination of flare-outs, the invention could in some aspects be used to prevent overheating of electrodes without the actual existence of a flare-out. The generator, detecting criteria indicating the start of a potential overheating situation, could reduce the power or alter the radio frequency signal in other ways so as to maintain operation of the electrosurgical system operating within proper parameters. Those skilled in the art of electrosurgical generators will readily be able to establish suitable detection criteria to keep the generator operating within safe and effective limits.

1a

This is a continuation of application Ser. No. 08/357,999 filed on Dec. 16, 1994, now U.S. Pat. No. 5,643,296. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention generally relates to the construction and use of vascular catheters. More particularly, the invention relates to intravascular catheters having a work element within a distal housing, and a work element guiding structure. 2. Previous Art Arteriosclerosis, also known as atherosclerosis, is a disease characterized by the deposition of a fat-like substances, referred to as atheroma or plaque, on the walls of blood vessels. Such deposits can occur both in peripheral blood vessels that feed the limbs of the body and in coronary blood vessels that feed the heart. When deposits accumulate in localized regions of a blood vessel, the regions become "stenosed;" blood flow is restricted and the person's health is at serious risk. Numerous approaches for restoring blood flow by reducing and removing stenotic deposits have been proposed. Balloon angioplasty, for example, uses a balloon-tipped catheter to dilate the stenosed region. Atherectomy procedures use a blade or other cutting element to sever and remove stenotic material. Laser angioplasty directs laser energy to ablate at least a portion of the stenotic material. Of particular interest are atherectomy catheters in which a cutting blade advances past an opening at the distal end of a vascular catheter. The catheter exposes the opening to at least a portion of the stenotic material. The stenotic material extends through the opening where the cutting blade advances and severs the stenotic material. Typically, such cutting blades are circular and are rotated (or rotationally oscillated) and advanced simultaneously to effect the desired cutting. Although such atherectomy catheters have enjoyed widespread success in both peripheral and coronary applications, certain design limitations persist. In small diameter catheters used in the coronary arteries, for example, very tight vascular bends are encountered. Typically, a guidewire is first inserted through the blood vessel and advanced along the lumen of the vessel until proximate to the stenosed region. The catheter slides over, and along, the guidewire until the catheter positions adjacent a stensosed region. Atherectomy catheters having rigid housings at their distal ends have difficulty inserting past tight vascular bends. The rigidity of the housing causes lateral displacement of the guidewire. Difficulties associated with guide wire movement and tight vascular bends are exacerbated by elongated housings which frequently collect severed stenotic material in a forward nosecone. In an effort to enhance the maneuverability within the tortuous regions of the coronary arteries, atherectomy catheters having flexible cutter housings have been employed. Commonly assigned flexible housings take various forms, including a braid-reinforced polymeric structure and a slotted metal tubular structure. Although flexible housings offer a significant improvement over comparably sized rigid cutter housings when employed in coronary arteries and other tortuous regions of the vascular system, they do present limitations. In particular, bending and flexing of the flexible housings inhibits the axial advancement of the cutting blades within the housing. Also, bending of the housing sometimes causes an advancing cutting blade to undesirably extend outward from the window. Outward extension of the cutting blade may render the cutting blade inoperable or interfere the housing and the guidewire. Such consequences prevent proper operation of the catheter by distorting the housing. Outwardly extending cutting blades are unwieldy and generally undesirable. Efforts to overcome undesired extension of cutting blades continue. Reducing the width of the housing window prevents extension of the cutting blades. This modification, however, reduces the amount of stenotic material which can be removed in a single pass of the cutting blade through the housing. Various related efforts manifest themselves in atherectomy catheters described in U.S. Pat. No. 4,926,858, issued May 22, 1990 to Gifford, III et al. entitled "ATHERECTOMY DEVICE FOR SEVERE OCCLUSIONS"; U.S. Pat. No. 4,979,951, issued Dec. 25, 1990, to Simpson, entitled "ATHERECTOMY DEVICE AND METHOD"; U.S. Pat. No. 5,047,040, issued Sep. 10, 1991, to Simpson et al. entitled "ATHERECTOMY DEVICE AND METHOD"; U.S. Pat. No. 5,084,010, issued Jan. 28, 1992, to Plaia et al., entitled "SYSTEM AND METHOD FOR CATHETER CONSTRUCTION"; and Re. 33,569, issued Apr. 9, 1991, to Gifford III et al. entitled "SINGLE LUMEN ATHERECTOMY CATHETER DEVICE". Of these, the 4,979,951 and Re. 33,569 patents describe catheters having distal housings in which a rotatable cutting blade receives a coaxial movable guidewire. Moveable guidewires generally do not securely hold the cutting blade within the housing. Additionally, in some devices, the guidewire itself may be severed by the cutting blade. Copending, U.S. Pat. No. 5,250,059, issued Oct. 5, 1993 to Andreas et al., entitled "ATHERECTOMY CATHETER HAVING FLEXIBLE NOSE CONE". application, and describes an atherectomy catheter having a flexible nose cone attached to the distal end of a cutter housing. A rotatable cutting blade is optionally received over a movable guidewire which passes through the nose cone, the housing and the cutting blade drive (torque) cable. Placement of the cutting blade of an atherectomy catheter over a conventional movable guidewire has been proposed (See, U.S. Pat. Nos. 4,669,469, and Re. 33,569). Conventional guidewires could restrain the cutting blade within the cutter housing under some circumstances. Unfortunately, the guidewire itself will often be displaced as the atherectomy catheter is advanced over the guidewire. Guidewire movement is due to the fine gauge (usually 0.007 inch) of the guide wire. Furthermore, since the guidewire is not fixed at its distal end, it does not necessarily conform to the specific distortions of the housing within a contorted blood vessel, and thus is not always efficient in guiding the cutter as it is advanced within the housing. Thus, movable guidewires cannot be relied on to cooperate with an axially translatable cutter within the cutter housing under all circumstances. Improved intravascular catheters are desired. In particular, it is desirable to provide a way of retaining a cutting blade (work element) within the housing of a catheter. It is desirable to provide a housing in which the cutting blade will not interfere with the guidewire or the housing of the catheter. It is desirable to provide a way of retaining the cutting blade which is compatible with housings of various sizes and configurations. SUMMARY AND OBJECTS OF THE INVENTION The various objects of the invention which are presented and which will become apparent below are presented by way of example only and are not intended to limit the scope of the present invention. The present invention is to be limited only by the Claims. It is an object of this invention to provide intravascular catheters suitable for operation in blood vessels with tight bends. It is a further object of this invention to provide intravascular catheters with work elements that are retained within flexible distal housings during insertion and operation of the catheter. It is a further object of this invention to provide intravascular catheters with a work element that follows the longitudinal path of the housing during axially translation of the work element. It is a further object of this invention to provide methods of using intravascular catheters with guiding structures in intravascular surgical interventions. It is a further object of this invention to provide methods of using atherectomy catheters with guiding structures to perform coronary atherectomies. In accordance with the above objects and those that will be mentioned and will become apparent below, the intravascular catheter of the present invention comprises: a catheter body having a proximal end, a distal end and a lumen therebetween; a housing with a cylindrical body, a longitudinal axis, an internal surface, an external surface, a window on a lateral side thereof, and an open proximal end secured to the distal end of the catheter body, the housing defining a hollow interior; a work element disposed within the housing and having a proximal end; a cable substantially disposed within the lumen of the catheter body, the connector having a proximal end and a distal end and the distal end being connected to the proximal end of the work element; a guiding structure affixed to the housing and slidably connected to the work element, the guiding structure defining a fixed axial path relative to the housing, whereby the work element is retained within the housing during insertion of the catheter within a blood vessel and during axial translation of the work element along the axial path of the guiding structure. The catheters of the embodiments of the present invention all include a guiding structure affixed to or incorporated into the housing and slidably connected to the work element. The catheters also have other additional features in common. These include a long flexible catheter body with a housing attached to the distal end. The housing has an opening along a lateral side. The work element is disposed within the housing. A cable is attached to the work element. The connector goes from the work element, through the catheter body and out its proximal end. The work element within the housing is operated from the proximal end of the catheter body via the cable. In an embodiment of the invention, the guiding member includes at least two longitudinal slots through the internal surface of the housing. A slider is attached to the work element and has pins projecting radially that are positioned within each slot and able to slide along the slot as the work element is moved back and forth. The angle between the pins insures that the pins remain in their slots and this insures that the work element stays within the housing and follows the axial path of the housing even when the housing is bent. In another embodiment, a single longitudinal slot is provided along the housing. This slot is substantially a tunnel within the body of the housing and communicates with the hollow interior of the housing through a narrow axial neck. A slidable pin conforming to the shape of the slot is positioned within the slot and attached to a slider which in turn is attached to the work element, thereby registering the axial path of the work element to the housing. In an additional embodiment, the guiding member is a longitudinal shaft, sometimes tubular and sometimes ribbon shaped, usually flexible. The shaft is positioned within the hollow interior of the housing and attached to the housing. The shaft passes through a tunnel attached to or within the work element such that the work element is slidable along the shaft. In a particular configuration of this embodiment, the shaft is coaxial with the longitudinal axis of the housing and the tunnel is in the center of the work element, permitting the work element to rotate about the shaft. In yet another embodiment, the guiding member includes the exterior surface of the housing, and a band is coupled to the work element and circumscribes the exterior surface of the housing. The band slides alone with the work element and keeps the work element inside of the housing. According to an embodiment of the method of the present invention, an intravascular catheter as described herein is provided. The catheter is inserted into the lumen of a blood vessel starting from the distal end of the catheter. The catheter is advanced until the housing is adjacent to a site of interest, e.g. stenotic material within a blood vessel. The work element is then operated in a manner specific to the function of the work element. The path of axial movement of the work element within the housing is registered to the axial path provided by the guiding member. The intravascular catheter of the present invention can be fitted with a variety of work elements each performing a specific task. The cable is chosen to complement the function of the work element. For example, when the work element is a cutting blade, the cable is rotated which in turn rotates, the cutting blade, the cable is translated to axially to advance the cutting blade past the lateral window of the housing, whereby stenotic material extending through the window into the hollow interior of the housing is severed. It is to be understood that the intravascular catheter of the present invention is conceived to operate with a variety of work elements and corresponding connectors that differ in the interventional task that each is designed to perform. A wide variety of work elements (and cables) are known to those skilled in the art, e.g. cutting blades (and cables) for performing atherectomy procedures, heated elements (electrical wires) for performing thermal ablation, electrodes (electrical wires) for performing electrosurgical cutting and cauterization, abrasive elements for performing mechanical ablation (cables), optical waveguides (fiber optic lines) for performing laser ablation, ultrasonic transducers (ultrasonic transduction lines) for imaging and ablation, angioscopic imaging devices (fiber optic lines) and the like. The present invention is particularly useful for work elements requiring axial translation during operation. It is an advantage of the intravascular catheters of the instant invention to be operable in blood vessels with tight bends, e.g. coronary arteries. It is a further advantage of the catheters of this invention to be compatible with flexible housings and to be operable when the housing is bent or distorted. It is an additional advantage of the catheters of this invention to have work elements whose axial translational path is registered to the axial path within the housing. It is a further advantage of the catheters of this invention that escape of the work element through the window on a lateral side of the housing is minimized. It is yet another advantage of this invention to be able to use housings with wide windows while retaining the work element within the housing. BRIEF DESCRIPTION OF THE DRAWINGS For a further understanding of the objects and advantages of the present invention, reference should be had to the following detailed description, taken in conjunction with the accompanying drawing, in which like parts are given like reference numerals and wherein: FIG. 1 is a side elevational view of an intravascular atherectomy catheter with the work Guiding structure of the present invention. FIG. 2 is a cross-sectional view along line 2--2 of FIG. 1 looking in the direction of the arrows. FIG. 3 is a detailed side view of an atherectomy cutter housing. FIG. 4 is a partial cross-sectional view of the cutting blade and slider shown in FIG. 3. FIG. 5 is a cross-sectional view of FIG. 3 taken alone line 5--5 looking in the direction of the arrows. FIG. 6 is a cross-sectional view of FIG. 3 taken along line 6--6 looking in the direction of the arrows. FIG. 7 is a cross-sectional view of FIG. 4 taken along line 7--7 looking in the direction of the arrows. FIG. 8 is a cross-sectional view illustrating another embodiment of the guiding structure. FIG. 9 is a partial sectional view of FIG. 8 taken along the line 9--9 looking in the direction of the arrows. FIG. 10 is a cross-sectional side view of an additional embodiment of the guiding structure. FIGS. 11 and 12 illustrate the operation of the atherectomy device of FIG. 10 in severing stenotic material from a blood vessel. FIG. 13 is a cross-sectional view of a preferred embodiment of the guiding structure of the present invention. FIG. 14 is a cross-sectional view of FIG. 13 as seen along line 14--14 looking in the direction of the arrows. FIG. 15 is a side view illustrating a further embodiment of the guiding structure of the present invention. FIG. 16 is a side view illustrating a detail of the guiding structure shown in FIG. 15. FIG. 17 is a cross-sectional view of FIG. 15 taken along line 17--17 looking in the direction of the arrows. FIG. 18 is a cross-sectional view of FIG. 15 taken along line 18--18 looking in the direction of the arrows. DETAILED DESCRIPTION OF THE INVENTION The present invention provides intravascular catheters with guiding structures 100. The catheters include an elongated flexible catheter body and a housing secured to the distal end of the catheter body. The housing holds the work element adjacent to an elongated window. The window is located on a lateral side of the housing. A cable extends through a lumen of the catheter body and attaches to the work element. The cable operates the work element within the housing. The invention features guidance and retention structures for the work element within the housing. Particularly, the invention provides a guiding member that retains the work element within the housing, prevents escape of the work element through the window of the housing, and guides the axial translation of the work element along the longitudinal axis of the housing. The work element is thus contained when very wide windows are provided in the housing or when the housing is flexible and subjected to bending, deformation or distortion which might otherwise cause the work element to be lost from the housing. The present invention is useful with a wide variety of catheters having virtually any type of axially translatable work element. The present invention is especially useful in atherectomy applications where the work element is a rotating or rotationally oscillating cutting blade and is operated by simultaneously rotating and axially advancing the blade past the side window in the housing in order to sever and remove stenotic material from an area of interest, e.g. a stenosed region of blood vessel. Such atherectomy devices and procedures are described in U.S. Pat. Nos. 4,669,469; 4,926,858; 4.979,951; 5,047,040; 5,084,010; and Re. 33,569, the full disclosures of which are incorporated herein by reference. Preferred embodiments of the present invention are catheters particularly adapted to perform atherectomies. Consequently, in several embodiments the work element is referred to as a "cutting blade" and the cable is referred to as a "cable". It is to be understood, however, that the work guiding structure 100s of the present invention can be used with many other catheter types, all of which are within the intended scope of this invention. Referring now to the drawings, a number of exemplary embodiments of catheters employing work element guide systems constructed in accordance with the principles of the present invention will be described. It will be appreciated, however, that these embodiments are merely exemplary and that a wide variety of other specific implementations are within the scope of the present invention. Referring now to FIGS. 1 and 2, FIG. 1 shows a side view of an intravascular catheter generally indicated by the reference numeral 110. FIG. 2 a is cross-sectional view of the catheter body 112 of FIG. 1 as seen along the line 2--2 in the direction of the arrows. The catheter body 112 includes a housing 140 with a window 142, a work element 138, and a cable 134. With particular reference to FIG. 1, there is shown the catheter body 112 which has a proximal end 114, a distal end 116 and at least one internal lumen 133 (FIG. 2). The housing 140 includes a distal end 141 and a proximal end 139. A hollow nose cone 144 attaches to and covers the distal end 141 of the housing 140. The distal end 116 of the catheter body 112 attaches to the proximal end 139 of the housing 140. The lumen 133 of the catheter body 112 holds the cable 134. The housing 140 is a hollow cylinder having an axis 137, an inner surface 108, an outer surface 109, and a window 142. The proximal end 139 and distal end 141 of the housing 140 are open to establish communication between the catheter body 112 and the nose cone 144. A balloon 126 attaches on the outer surface 109 of the housing 140 on the side opposite from the window 142. The balloon 126 communicates with a balloon inflation lumen 135 within the catheter body 112 (FIG. 2). The balloon is inflated when the catheter 110 is positioned within a blood vessel. When the balloon 126 inflates, the balloon 126 pushes the window 142 of the housing 140 against the internal wall of the blood vessel. Atheroma, for example, are invaginated by the window 142 in this way (see FIGS. 11 and 12). The work element 138 aligns adjacent the window 142. When the window 142 invaginates atheroma, the work element 138 slides within the housing 140 and rotates to cut small pieces of the atheroma. Actuation of the cable 134 rotates and axially translates the work element 138 during operation. An inflation manifold 118 secures a rotator assembly 120 to the proximal end 114 of the catheter body 112. The rotator assembly 120 permits the catheter body 112 to rotate relative to the inflation manifold 118. A transition element 122 forms over the proximal end 114 of the catheter body 112 and relieves stress between the catheter body 112 and the inflation manifold 118. A fitting 124 on the inflation manifold 118 connects in fluid communication with the with balloon inflation lumen 135 in the catheter body 112. A connector 128 on the inflation manifold 118 interconnects a perfusion or aspiration source in fluid communication with a perfusion lumen of the catheter body 112. A spline 130 suitable for connection to a motor drive unit (such as that disclosed in U.S. Pat. No. 4,771,774, the disclosure of which is incorporated herein by reference) is secured to a drive shaft 132. The drive shaft 132 connects to the cable 134. The cable 134 extends through the lumen 133 which extends the entire length of the catheter body 112. The cable 134 rotates the work element 138 during operation. An axial advance lever 136 mounts on the drive shaft 132. The lever 136 permits manual axial translation of the cable 134 and work element 138. A guidewire 146 positions the catheter 110 into an intravascular location, for example. Typically, the guidewire 146 first inserts into a blood vessel. The catheter 110 inserts over the guidewire 146. The guidewire 146 precisely guides the catheter into a desired position within the vascular system of a patient. A lumen 147 in the cable 134 and the nose cone 144 provides a path for the guidewire along the longitudinal axis 137 of the housing 140. The guidewire 146 also passes through a lumen (not shown) in the work element 138. Referring now to FIGS. 3 through 7, a preferred embodiment of the intravascular catheter of the present invention is shown having a work element 138 and a guiding structure 100. For purposes of the present invention, the work element 138 includes an arcuate cutting edge, for example. As seen in FIG. 3, the invention includes a housing 140 with slots 150, a slider 152 with at least one pin 156, a work element 138, and a cable 134. It will be appreciated that the pin 156 could also be formed in the shape of a spline. The slots 150 align inside the housing 140 in parallel with the longitudinal axis 137 (FIG. 1). The slots 150 extend through the housing 140. It should be noted that the slots 150 may extend only partially through the housing 140. The slots 150 receive the pins 156. The pins 156 slide within the slots 150. In the embodiment illustrated in FIG. 3, two slots 150 are shown, however it is to be understood that one or more slots 150 and a corresponding number of pins 156 may be used in accordance with the present invention. Additionally, the slots 150 need not be straight and aligned with the axis of the housing 140. The slots 150 may assume a slightly helical shape for example. The pins 156 extend radially from the outer surface of the slider 152. The slider 152 is a cylinder and mounts over a bearing 154 (FIG. 4). The bearing 154 of the slider 152 mounts on the cable 134. When the cable 134 rotates, the slider 152 does not rotate. The slider 152 slides with the work element 138 and the cable 134. The slider 152 is a cylinder mounted over a bearing 154 (FIG. 4). The bearing 154 mounts around cable 134. The interior of the bearing 154 is affixed to the cable 134 permitting the cable 134 and the interior of the bearing 154 to rotate (at high speed if necessary). The slider 152 remains rotationally stationary within the housing 140 when the cable 134 rotates. The bearing 154 maintains the position of the slider on the cutter torque cable. The work element 138 is a cylindrical atherectomy cutting blade attached to the cable 134. Cable 134 rotation and translation respectively rotates or translates the work element 138. The slider 152 is also coupled to the cable 134 so that it will axially translate therewith. The slide 152 does not rotate when the cable 134 rotates. Thus, the slider 152 remains rotationally stationary with respect to the housing 140 even as the cable 134 rotates the work element 138. The slider 152 thus guides the work element 138 along the slots 150 with the pins 156. The preferred embodiment illustrated in FIGS. 3-7 is useful with flexible housings and with rigid housings. Particular geometries and dimensions of the slots 150 and slider 152 and pins 156 may be varied widely within the scope of the present invention so long as the guiding structure 100 retains the work element 138 within the housing 140. Referring now to FIGS. 8 and 9, a preferred embodiment of the pin 156 and the slots 150 of the atherectomy catheter 110 of FIG. 3 is shown. The pin 166 and the slot 160 shown in FIG. 8 differ in shape from the pins 156 and slots 150 of FIG. 6. A single pin and slot configuration is shown in FIG. 8 and FIG. 9. FIG. 8 shows a cross sectional view of the housing 140 of the present invention. FIG. 9 provides a larger scale view of the slot 160 and the pin 66 in the region demarcated by line 9--9 in FIG. 8. The slot 160 is formed on the inner surface 161 of the housing 140. The pin 166 extends into the slot 160 partially through the housing 140. The pin 166 and the slot 160 may also extend fully through the housing 140 (see FIG. 3). As shown, the slot 160 tunnels longitudinally within the body of the housing 140. The slot 160 communicates with the hollow interior of the housing, 140 via a narrow-necked portion 167 of the slot 160. The pin 166 forms a "T" shaped cross-section that complements the shape of the narrow-necked portion 167 of the slot 160. The pin 166 is thus free to axially translate within the slot 160. The slot 60 radially locks the pin 166 with the housing 140. The slot 160 restrains the pin 66 an prevents movement of the pin 166 in the radial direction relative to the housing 140. A wide variety of pin/slot cross-sectional geometries (including, but not limited to a cross, a lollypop, an oblong, a diamond, etc.) provide the same functions of guidance and retention and are within the scope of the present invention. The pin 160 can also be a bar having the shape of a railroad track section for example. Referring now to FIGS. 10 through 12, another embodiment of the catheter of the present invention is shown. The invention includes housing 140 with window 142, catheter body 112, work element 138, cable 134, and coaxial rod or shaft 170. "BV" generaly indicates a cut away view of a blood vessel. "SM" indicates stenotic material on the interior wall of the blood vessel. FIG. 10 is a cross-sectional side view of the housing 140. The guiding structure 100 includes a shaft 170. The shaft 170 attaches to the end 172 of the nose cone 144. The shaft 170 may be rigid or flexible, solid or hollow. Preferably, a flexible hollow shaft 170 is used with a flexible housing 140. As shown, the shaft 170 aligns coaxially with the housing 140 and is hollow for circumscribing a guidewire 146 (see FIG. 1). The housing is fabricated from a resilient material, such as an elastomeric polymer. The shaft 170 is formed from flexible material, for example, a tube formed from a superelastic alloy such as nickel-titanium alloy. A suitable superelastic alloy is commercially available and is fabricated under the trade name Nitinol® by Advanced Cardiovascular Systems, Santa Clara, Calif. Tubes formed from superelastic alloys desireably conform and bend in relation to the bending of the housing 140. Such tubes generally provide a smooth arc of curvature which the work element 138 follows. Use of the shaft 170 guide system provides further advantages in that it facilitates proximal retraction of the work element 138, as illustrated in FIG. 10 in broken line. The work element 138 can be withdrawn proximally from the housing 140 into the catheter body 112 while the work element 138 remains on the shaft 170. The work element 138 is removed as an impediment to the flow of blood (or other fluid) from the interior of the distal portion of the catheter body 112 through the housing 140. The catheter body 112 is adapted to receive the work element 140 by flaring the distal end 116 of catheter body 112 over the proximal end of the housing 140, as illustrated. The distal end 116 can then be secured to the proximal end of the housing 140 using a connecting ring 76. Bypass perfusion ports 178 are provided within the distal portion of the catheter body 112 and proximal to the distal end of the catheter body 112, as described in more detail in copending application Ser. No. 08/236,485 filed Apr. 29, 1994 (attorney docket number DEVI 1464), and entitled "Catheter with Perfusion System", the full disclosure of which is incorporated herein by reference. FIGS. 11 and 12 illustrate operation of an atherectomy catheter within the scope of the present embodiment. In FIG. 11 the housing 140 is located within a curved region of blood vessel BV. Stenotic material SM is located on the outer radius of the curve so that the housing 140 is located with housing window 142 directed radially outward. It will be appreciated that, with the housing 140 in such a configuration, the unguided work element 138 has a tendency to travel outward through the window 142 and into the wall of the blood vessel BV. Such a trajectory is not desirable since it can damage the blood vessel wall. Shaft 170 defines a curved travel path which maintains the work element 138 generally within the housing 140 and inhibits undesirable deviation of the cutter into the blood vessel wall. In FIG. 12, use of an atherectomy catheter in removal of stenotic material SM along the inside radius of curvature of a blood vessel BV is illustrated. When the housing window 142 is on the inside radius of curvature, the work element 138 tends to cut into the inside wall of the housing 140, rather than cutting alone the optimal path for removal of stenotic material SM. The shaft 170 again defines the proper travel path for the work element 138 so that it avoids cutting into the housings 140 and is properly disposed to remove the stenotic material SM, as illustrated. Referring now to FIGS. 13 and 14, an embodiment of the catheter with a guiding structure 100 is illustrated. The embodiment includes housing 140 formed with a window 142, a work element 138, a cable 134, a ribbon 180, and a slider 152. The housing includes a keyway 185. The work element 138 includes a slider 152 having an outer surface 163 with an extension 187. The extension 187 defines guide hole 195 which recieves the ribbon 180. The slider 152 holds the work element 138 in a desired position with respect to the housing 140. The extension 187 slides along the keyway 185. The ribbon 180 holds the keyway 185 and the extension 187 together. The ribbon 180 extends from the proximal end 139 of the housing 140 to the distal end 141 of the housing 140. The holes 193 formed in the housing 140 hold each end of the ribbon 180. The ribbon 180 extends through the guide hole 195 formed in the housing 140 to lock the work element 138 against the housing 140. FIG. 13 is a cross-sectional view of the housing FIG. 14 is a cross sectional view of the housing in FIG. 13 as seen along the line 14--14. The ribbon 180 is a shaft with a flat geometry and is secured to the distal end of housing 140, typically being attached to a ring 182 which secures the nose cone 144 to the housing. The ribbon 180 has a width that is at least 1.5 times its thickness, preferably at least 3 times its thickness. The ribbon 180 is metallic, and preferebly made from the family of metals known as superelastic alloys, and most preferably Nitinol®. Referring now to FIGS. 15-18 still another embodiment of the catheter with guiding structure 100 is illustrated. The housing 140 has an outer surface 109 with a smooth exterior portion 191. The work element 138 is formed with an annular depression 192. The guiding structure 100 includes a band 190. FIG. 15 is a side view illustrating the outer surface 183 of the housing 140 and the guiding structure 100. The band 190 couples the work element 138 with outer surface 109 of the housing 140. An annular depression 192 forms in the housing 140. The annular depression 192 accepts the band 190. The band 190 surrounds the outer surface 109 of the housing 140 over the smooth portion 191 of the housing 140. In FIG. 16, the work element attaches to a protective member 193. The annular depression 192, work element 138, protective member 193 and the band 190 are shown. FIGS. 17 and 18 are cross-sectional views through the lines 17--17 and 18--18 respectively, shown in FIG. 15. The work element 138 rotates. The band 190 remains rotationally stationary. The band 190 flexes and translates axially when the work element 138 moves. The band 190 is fabricated from a metal, or a lubricious polymer, such as nylon, or polymers and copolymers of tetrafluoroethylene, or the like. The protective member 193 attaches to the housing 140 between the band 190 and the balloon 126 to prevent damage to the balloon 126 when the band 190 slides on the housing 140. As described, the present invention is especially useful in atherectomy applications where the work element 138 is a rotating or rotationally oscillating cutting blade, and is operated by simultaneously rotationally translating and axially translating the blade 138 past the side window 142 in the housing 140 in order to sever and remove stenotic material from an area of interest, e.g. a stenosed region of blood vessel. However, other embodiments utilizing the guiding structures 100 described above are contemplated and are within the scope of the present invention. Examples of intravascular catheters containing alternative work elements 138 include, but are not limited to, cutting blades for performing atherectomy procedures, heated elements for performing thermal ablation, electrodes for performing electrosurgical cutting and cauterizing, abrasive elements for performing mechanical ablation, optical wave guides for performing laser ablation, ultrasonic transducers for imaging or ablation, fiber optical elements for visualization and imaging, and the like. In each case, the cable 134 is appropriate to facilitate operation of the work element 138. For example, a cutting blade utilizes a cable, thermal ablators utilize electrical wires, laser ablators utilize optical elements, etc. Work element connectors appropriate for each work element are known to those skilled in the art. It will be appreciated that intravascular introduction of a catheter, particularly into coronary arteries, frequently requires the catheter to pass through very tight turns and bends resulting from the tortuosity of the blood vessels. The guiding structure 100 of the present invention facilitates axial advancement of the cutting blade while the cutter housing is positioned in such tortuous regions, particularly by inhibiting loss of the cutting blade from flexible housings through the work window. The advantages of the present invention, however, also extend to the use of rigid cutter housings in less tortuous regions, where the cutter guide system of the present invention allows for the use of very wide work windows where, in the absence of the guide, the cutter would be at risk of escaping from the housing. Wider work windows are desirable for cutting, ablation, and viewing or imaging of larger regions of the vascular wall. Fixed axial registration of the guiding member and housing help assure that the guiding member remains properly aligned within the housing. By "fixed", it is meant that the guiding member will not translate axially relative to the housing, although some degree of radial movement will be acceptable and, in some cases, even necessary. Axial paths defined by slots and channels which are formed in or on the interior surface of the housing will necessarily be fixed relative to the housing. Elongated members comprising shafts, bands and the like, are attached to the housing at least one end, preferably both ends. Such attachment may be direct, i.e., formed directly between the guiding member and a surface of the housing, or may be indirect, i.e., made through a separate component of the catheter which is itself fixed relative to the housing e.g., a nose cone, a housing connection ring, a portion of the catheter body, or the like. Such separately formed guiding members may, of course, directly or indirectly attach to the housing at more than one location. Moveable guidewires have been used as a guiding structure in intravascular catheters. However, movable guidewires (which are free to axially translate relative to the housing) will often become axially misaligned within the housing as the catheter is advanced thereover. That is, the movable guidewire can be axially collapsed as the catheter is advanced, causing a pronounced lateral deflection within the interior of the housing. Such lateral deflection is unacceptable to define the axial path for the work element to track. The guiding structure 100s disclosed in the present invention solve this problem in that they define an axial path that is fixed relative to the housing. Materials As described, the housing may be rigid or flexible, typically being formed from a metal, such as surgical stainless steel, organic polymers such as polyacetyl, reinforced polymers such as graphite filled polyesters and ceramics. A rigid housing has a generally continuous construction, usually composed of a metal or rigid plastic, including the side window but free from other spacings or voids intended to enhance bendability. A flexible housing is usually formed from resilient materials, such as polyurethanes, elastomeric polyesters and the like, or if formed from metal or other rigid (non-resilient) material will include spacings or voids which are intended to facilitate bending. The constructions of particular flexible housings are illustrated in U.S. Pat. No. 4,781,186 and U.S. Pat. No. 5,226,909 the disclosures of which are incorporated herein by reference. The slots formed in the housing may penetrate entirely through the housing wall, or may only partially penetrate the wall. A single slot may be formed, in which case it is desirable that the slot have cross-sectional geometry which locks in the coupling means, e.g., a T-shaped profile as illustrated in FIG. 8. In the case of multiple slots, it is less important that the coupling element be locked in. Coaxial shafts and off-set bands used as a guiding member may be rigid or flexible, depending primarily on the nature of the housing. Flexible tracking elements are preferred in flexible housings, but can also be used in rigid housings. The elongated catheter body of the present invention typically comprises a flexible tube which can be similar in construction to a wide variety of intravascular catheters, the type which are well known in the art. The flexible tube will have a proximal end and a distal end and at least one lumen extending therebetween. The tube may be formed by extrusion of an organic polymer, typically a thermoplastic, such as nylon, polyurethane, polyethylene terephthalate (PET), polyvinylchloride (PVC), polyethylene, and the like. The tubes so formed may be reinforced or unreinforced, usually being reinforced by a metal braid which is laminated with the polymeric material. Use of the metal braid reinforcement layer is desirable since it facilitates torquing and positioning of the cutter housing, as described in more detail below. The catheter body will typically have a length from about 40 cm to 200 cm, with shorter catheters in the range from abut 40 cm to 120 cm being used for peripheral applications and longer catheters in the range from about 100 cm to 200 cm being used for coronary applications. The diameter of the catheter body may also vary, with smaller diameter catheters in the range from about 3 French (F; 1F=0.33 mm) to 6F, for coronary applications and a diameter from 3F to 11F for peripheral applications. When the catheter is an atherectomy catheter, the cutter housing defines an open or hollow interior volume to receive stenotic material which penetrates or passes through the side window. The cutting blade is advanced past the window severing the stenotic material and advancing the severed atheroma toward the distal end of the housing. The distal end of the housing will typically be open and connected to a nose cone so that the severed stenotic material can be moved into the nose cone for storage. In certain embodiments the cutter defines a cup-shaped cutting blade which is rotated (or rotationally oscillated) and advanced to sever the atheroma and urge the atheroma in a forward direction. Such cutting blades are illustrated in U.S. Pat. No. 4,979,951 and Reissue Pat. No. 33,569, the disclosures of which have previously been incorporated herein by reference. The length of the cutter housing will depend primarily on the desired length of stenotic material to be severed, with the limitation that longer housings are more difficult to manipulate through the vascular system. Typically, the length of the housing is 5 mm to 40 mm. For coronary applications, the housing length will generally be at the shorter end of the range, usually being from about 8 mm to 17 mm. The housing diameter will generally correspond to the diameter of the flexible tube, i.e. usually being in the range from about 3F to 11F. The cutter window within the housing typically extends over at least half of the housing length, and in other embodiments the cutter window extends over at least three-quarters of the housing length. It will be appreciated that it is desirable to maximize the length of the housing in order to increase the amount of stenotic material which can be removed in a single pass of the cutting blade. It is also desirable to increase the width of the housing window for the same reason. The cutter guide system of the present invention is particularly advantageous since it permits cutter windows having a greater width that was generally possible with previous atherectomy catheter designs. For cylindrical housings, the cutter width will typically subtend an arc of at least 115°, preferably subtending an arc of at least 130°, and may subtend an arc of 180°, or greater. The use of such wide housing windows is possible only because the guide system of the present invention will contain the cutting blade generally within the interior of the housing, even when the housing is subjected to bending and other deformation stresses which might otherwise cause the cutter to escape from the housing through the housing window. While the foregoing detailed description has described a preferred embodiment of the intravascular catheter, it is to be understood that the above description is illustrative only and not limiting of the disclosed invention. Particularly, the specific details of the geometry of slots and pins can differ from those illustrated and described so long as the guidance system guides and retains the work element within the housing. The invention is to be limited only by the claims set forth below.

1a

CROSS REFERENCE TO RELATED APPLICATION This is a divisional of application Ser. No. 14/069,729, filed Nov. 1, 2013, which is incorporated herein by reference. BACKGROUND OF THE INVENTION Field of the Invention This invention relates generally to methods and devices for invasive medical treatment. More particularly, this invention relates to improvements in catheters. Description of the Related Art Cardiac arrhythmias, such as atrial fibrillation, occur when regions of cardiac tissue abnormally conduct electric signals to adjacent tissue, thereby disrupting the normal cardiac cycle and causing asynchronous rhythm. Procedures for treating arrhythmia include surgically disrupting the origin of the signals causing the arrhythmia, as well as disrupting the conducting pathway for such signals. By selectively ablating cardiac tissue by application of energy via a catheter, it is sometimes possible to cease or modify the propagation of unwanted electrical signals from one portion of the heart to another. The ablation process destroys the unwanted electrical pathways by formation of non-conducting lesions. One such catheter is proposed in PCT patent document WO 2012/174375. The catheter has a balloon that may be expanded at some portions along its length through inflation. The catheter may have one or more differently compliant sections along its length, or may have a generally noncompliant body with one or more separate compliant portions overlying it. The compliant portions may be separately inflated to create, in one section of the catheter an expanded disk-like configuration with a circular, somewhat planar surface that is oriented orthogonally to the direction of the guide wire and facing in a distal direction. The catheter bears one or more RF electrodes that are capable of conducting RF energy and may be positioned on the surface of the balloon such that they take a circular configuration on the planar surface. SUMMARY OF THE INVENTION There is provided according to embodiments of the invention a medical apparatus, including a catheter having an elongated shaft and a distal portion. The distal portion includes an inflatable assembly, wherein the inflatable assembly includes a containment chamber, an axial core and a plurality of longitudinally oriented partitions extending from the axial core to the wall of the chamber to divide the containment chamber into at least four inflatable sectors. The sectors are externally delimited by respective bounding portions of the outer surface. Hydraulic valves are connected to respective sectors to enable selective inflation of the sectors by a fluid when the valves are connected to a source of the fluid, and at least one surface electrode is mounted on each of the bounding portions. The apparatus may include a tip electrode disposed on the catheter distal to the inflatable assembly. According to another aspect of the apparatus, the outer surface has perforations formed therethrough for egress of the fluid from the containment chamber. The apparatus may include a control processor operative to control the valves. According to another aspect of the apparatus, the at least one surface electrode is deformable when their respective sectors inflate and deflate. There is further provided according to embodiments of the invention a method of catheterization, which is carried out by introducing a catheter into a heart chamber of a subject. The distal portion of the catheter includes an inflatable assembly. The inflatable assembly includes a containment chamber, an axial core and a plurality of longitudinally oriented partitions extending from the axial core to the wall of the chamber to divide the containment chamber into at least four inflatable sectors. The sectors are externally delimited by respective bounding portions of the outer surface. Hydraulic valves are connected to respective sectors to enable selective inflation of the sectors by a fluid when the valves are connected to a source of the fluid, and at least one surface electrode is mounted on each of the bounding portions. The method is further carried out by inflating a selected one of the pairs of the sectors sufficiently to stably press the outer surface of the pairs of the inflated sectors against the walls of the heart chamber while avoiding inflation of others of the sectors, wherein the at least one surface electrode of each sector of the selected pair contacts the walls of the heart chamber. Another aspect of the method is performed after inflating the selected pair of sector by measuring electrical potentials from the at least one surface electrode of the sectors of the selected pair. The method may include passing an electric current through at least one surface electrode to ablate a portion of the walls of the heart chamber. One aspect of the method is performed after inflating the selected pair of sectors by deflating the selected pair of the sectors, and thereafter inflating another one of the pairs. In a further aspect of the method the outer surface has perforations formed therethrough, wherein inflating comprises flowing the fluid through the valves into the selected pairs of the sectors. The method further includes controlling the valves to admit the fluid into the selected pair and to exclude the fluid from sectors other than the selected pair, and cooling a surface electrode of the selected pair during ablation of the selected pair by egressing the fluid from the containment chamber via the perforations. According to still another aspect of the method, the members of the selected pair of the sectors are inflated concurrently. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS For a better understanding of the present invention, reference is made to the detailed description of the invention, by way of example, which is to be read in conjunction with the following drawings, wherein like elements are given like reference numerals, and wherein: FIG. 1 is a schematic, pictorial illustration of a vascular catheterization system, in accordance with an embodiment of the present invention; FIG. 2 is a longitudinal schematic view of the distal portion of a catheter in accordance with an embodiment of the invention; FIG. 3 is a schematic cross-sectional view of the catheter shown in FIG. 2 through line 3 - 3 , in accordance with an embodiment of the invention; and FIG. 4 is a flow chart of a method of cardiac catheterization using a segmented balloon catheter, in accordance with an embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION In the following description, numerous specific details are set forth in order to provide a thorough understanding of the various principles of the present invention. It will be apparent to one skilled in the art, however, that not all these details are necessarily always needed for practicing the present invention. In this instance, well-known circuits, control logic, and the details of computer program instructions for conventional algorithms and processes have not been shown in detail in order not to obscure the general concepts unnecessarily. System Description Turning now to the drawings, Reference is initially made to FIG. 1 , which is a schematic, pictorial illustration of a vascular catheterization system 10 in accordance with an embodiment of the present invention. Use of the system 10 involves inserting a catheter 12 into the body of a subject 14 at an insertion point 30 , for example a femoral artery or vein; thence into an internal body cavity, such as a heart chamber. Typically, the catheter 12 is used for diagnostic or therapeutic treatment performed by a medical practitioner 16 , such as mapping electrical potentials in the heart or performing ablation of heart tissue. The catheter 12 may alternatively be used for other purposes, by itself or in conjunction with other treatment devices. Supporting elements related to the medical procedure are found in a control unit 26 , which contains processors for data reported by signals from sensors in the catheter 12 , e.g., via a cable 32 . The control unit 26 may include an ablator power generator, irrigation pump and electrocardiographic circuitry. Events and data reported to the control unit 26 may be displayed on a monitor 34 . However, as explained below, the control unit 26 need not include position-locating circuitry to track the location and orientation of the catheter 12 in the heart and elsewhere in the body of the subject 14 . The catheter 12 typically contains hydraulic lines to transfer fluid from the irrigation pump via the catheter's handle to the distal portion of the catheter 12 as explained below. The hydraulic connection to the pump is not shown in FIG. 1 in order to preserve clarity of illustration. Reference is now made to FIG. 2 , which is a longitudinal schematic view of the distal portion of a catheter 36 , which is useful for mapping regions in and around the heart and for tissue ablation in accordance with an embodiment of the invention. The catheter 36 comprises an elongated tubular shaft 38 . An inflatable balloon assembly 40 is provided at the distal end of the catheter body. The inflatable balloon assembly 40 comprises a containment chamber, which is internally partitioned into sectors 42 , 44 , 46 , 48 by a plurality of septa. The septa extend to an outer surface 50 from an axial core 52 and are oriented longitudinally about the axial core 52 . The sectors 42 , 44 , 46 , 48 are externally delimited by respective bounding portions of the outer surface 50 . Although four sectors are shown in FIG. 2 , the inflatable balloon assembly 40 may comprise any number of sectors greater than four. Surface features and functionality of the inflatable balloon assembly 40 are described below. The sectors 42 , 44 , 46 , 48 of the inflatable balloon assembly 40 must be flexible enough to maintain mechanical contact between the outer surface 50 and the wall of the heart chamber so that when inflated, they stably press the outer surface of the pairs of the inflated sectors against the wall of the heart chamber, but are not so rigid as to interfere with the movements of heart wall. The inflation pressure may be determined empirically by the operator, or may be determined using the teachings of U.S. patent application Ser. No. 13/343,024, entitled “Contact Assessment Based on Phase Measurement”, Govari et al., now published as U.S. Patent Publication No. 2013/0172875, which is herein incorporated by reference. The deflated sectors occupy little space and blood readily flows around them through the heart chamber, and thus blood flow through the heart is not substantially obstructed. A tip electrode 54 can optionally be used for local measurements and ablation when the inflatable balloon assembly 40 is deflated. Reference is now made to FIG. 3 , which is a schematic cross-sectional view of the catheter 36 through line 3 - 3 of FIG. 2 , in accordance with an embodiment of the invention. On this view, it can be appreciated that the inflatable balloon assembly 40 comprises a tubular structure comprising a pre-formed generally circular main region generally transverse and distal to the catheter body and having a circumferential outer surface 50 . Septa 56 , 58 , 60 , 62 extending radially from the core 52 to the outer surface 50 and define the sectors 42 , 44 , 46 , 48 . Each of the sectors 42 , 44 , 46 , 48 is independently connected to a fluid source 64 , and is selectively inflatable using control valves 66 , which deliver an irrigation fluid, typically saline, to the sectors 42 , 44 , 46 , 48 via respective fluid lines 68 . For example, sectors 44 , 48 , which oppose one another diametrically, are inflated concurrently, while the other sectors 42 , 46 remain deflated. Fluid may be supplied to the sectors 44 , 48 by simultaneously opening their respective control valves 66 . In any case, both of the sectors 44 , 48 become inflated in an operating position for taking measurements. The control unit 26 ( FIG. 1 ) may comprise a processor to regulate the control valves 66 . Alternatively, the control valves 66 may be controlled manually by the practitioner 16 or an assistant. The portion of the outer surface 50 overlying respective sectors 42 , 44 , 46 , 48 has a flexible array of electrodes 70 mounted thereon, which can be used for mapping and ablation. The electrodes 70 and associated connectors are required to deform as the sectors 42 , 44 , 46 , 48 expand and contract. Construction of flexible, stretchable electronic elements is known, for example from the documents Controlled Buckling of Semiconductor Nanoribbons for Stretchable Electronics , Yugang Sun et al., Nature Nanotechnology 1, 201-207 (2006) and U.S. Patent Application Publication No. 2011/0254171. Devices constructed in such manner are capable of conforming to curved surfaces and withstanding mechanical deformations. Optionally, perforations 72 may be formed through the outer surface 50 near the electrodes 70 . In such case, the fluid selectively delivered to the sectors 42 , 44 , 46 , 48 from the fluid source 64 egresses the inflatable balloon assembly 40 via the perforations 72 and cools the electrodes 70 and the ablation site during ablation. Operation Reference is now made to FIG. 4 , which is a flow chart of a method of cardiac catheterization using a segmented balloon catheter, in accordance with an embodiment of the invention. Not all illustrated process steps may be required to implement the process. At initial step 74 the catheter 36 ( FIG. 2 ) is inserted into the heart in a known manner, and positioned within a chamber of interest. At this point the sectors 42 , 44 , 46 , 48 are all deflated. Next, at step 76 , a diametrically opposing pair of sectors is selected, for example the sectors 44 , 48 ( FIG. 3 ). Next, at step 78 , the pair of sectors selected in step 76 are inflated. All non-selected sectors remain deflated. Next, at step 80 , electrical contact between the wall of the cardiac chamber and those electrodes 70 that are mounted on the selected sectors is verified. Next, at step 82 a measurement or procedure is performed using the electrodes 70 of the two opposing inflated sectors, for example bipolar measurements of electrical potentials during the cardiac cycle. Next, at decision step 84 , it is determined if more pairs of sectors of the inflatable balloon assembly 40 remain to be processed. If the determination at decision step 84 is affirmative, then control proceeds to step 86 . The current pair of inflated sectors is deflated. Control returns to step 76 to iterate the procedure with another pair of sectors. If the determination at decision step 84 is negative then at step 88 the current pair of inflated sectors is deflated. This could occur if all pairs have been inflated, or if it was decided to evaluate the signals obtained from fewer than all pairs of sectors. Indeed, it may be appropriate to evaluate the signals obtained from one pair of sectors before inflating the next pair. At step 90 , signals thus far collected from the endocardial surfaces via the electrodes of the pairs of inflated sectors are evaluated, either by the physician or automatically. After evaluating the ECG signals, as indicated by a broken line, selected pairs of sectors may optionally be reflated, and control would then return to step 76 . Alternatively, the physician typically makes a decision regarding ablation at final step 92 . It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

1a

OBJECT OF THE INVENTION [0001] The invention refers to a new type of disc prosthesis for application to the lumbar area especially designed to permit movement within the normal physiological limits of the invertebral disc, permitting lateralisation, flexion and extension under conditions which are as close as possible to the physiological ones. BACKGROUND OF THE INVENTION [0002] At the present time, one inconvenience of existing lumbar disc prostheses is that they permit excessive movement, i.e., above the physiological line. Excess movement above the physiological line causes regulation of the articulated box in the long term. One movement in particular that is poorly controlled is rotation. That is why our prosthesis permits movement on all planes but always within the physiological limits. In addition, and if the system fails, there is a blocking device that makes it possible through intervention to block all types of movement. DESCRIPTION OF THE INVENTION [0003] The lumbar disc prosthesis referred to herein basically comprises two pieces that can be adjoined to one another, both pieces adopting a kidney-shaped peripheral formation, the two pieces offering a bumpy external surface, with drilling of the horizontal and transversal material to form small, sharp pyramidal elevations covering the entire external configuration of both parts of the prosthesis. [0004] The upper piece of the lumbar disc, on the plane on which it makes contact with the lower piece, contains an ample oval-shaped, totally rounded cavity which can house the likewise oval-shaped protruding part of the lower piece to conform an oval-shaped central core with a central belt, thereby limiting all of the movements to the normal physiological limits of the invertebral disc. In particular, it is the only disc that limits rotation to levels within the normal range, also limiting lateralisation, flexion and extension under conditions that are appropriate for the function which the prosthesis is intended to perform, incorporating a blocking system that prevents either piece of the prostheses from moving forward to cause a dislocation. [0005] Another feature of this lumbar disc prosthesis is that is comes with assembly bolts that make it possible to block the disc with a rear mooring, the same one that is used to perform a lumbar arthrodesis. [0006] To join the pieces together, special bolts are used consisting of a smooth cylindrical body with a sharp end, while the head, which is the last part to be assembled and which is fixed to the upper outside part, is threaded on the outside so that when the bolts are housed in an oblique position, they will go through both pieces (the lower one through the oval-shaped domed protrusion) and the upper part which will house the sharp end, threaded finally by their respective heads at the entrance of the screw itself into the sides of the upper part, conforming the fully assembled lumbar disc prosthesis. DESCRIPTION OF THE FIGURES [0007] For a better understanding of the general features described above, enclosed herewith are figures which graphically and schematically represent a preferred practical embodiment of the lumbar disc prosthesis of the invention. It should be noted, given the eminently informative nature condition of the drawings in question, that the figures shown therein should be examined with discernment and without limitation, which figures represent the following: [0008] FIG. 1 shows a frontal view of the outside face of the upper part which adopts a kidney shape, the entire surface presenting a bumpiness formed of transversal and longitudinal slots that produce a plurality of small, sharp pyramidal protrusions. [0009] FIG. 2 shows a frontal view of the inside face of the upper piece, with an oval-shaped central cavity and threaded orifices on one edge to house the blocking bolts. [0010] FIG. 3 shows the same frontal view of the inside as FIG. 2 , in which the blocking bolts are assembled, positioned in an oblique arrangement, threaded by their heads to the upper part of the prosthesis. [0011] FIG. 4 shows a profile cross-section of the upper part, where the oval-shaped central cavity and the threaded orifices for the introduction of the blocking bolts are seen. [0012] FIG. 5 shows a frontal view of the inside of the kidney-shaped lower piece presenting an oval-shaped central protrusion with a central bolt, with the arrangement of orifices which run obliquely through the oval-shaped protrusion for the blocking bolts carrying the outside face with a serrated edge along the entire periphery. [0013] FIG. 6 shows a longitudinal profile of the lower piece according to FIG. 5 , where the oval-shaped protrusion and the orifices for the blocking bolts can be seen. [0014] FIG. 7 shows a longitudinal side view of the fitting system for the two pieces comprising the lumbar disc prosthesis, the outer surfaces of which two pieces are slightly jagged. [0015] FIG. 8 shows an elevation view of one of the bolts. [0016] FIG. 9 shows a longitudinal projection view of one of the blocking bolts, with threading on the outside of the head. PREFERENTIAL EMBODIMENT OF THE INVENTION [0017] Always referring to the attached drawings, it should be noted that in the different figures designed therein, numerical elevations have been incorporated related to the descriptions of the characteristics and operations described below, thereby facilitating their immediate location. Hence, ( 1 ) and ( 2 ) are the complementary upper and lower parts of the disc prosthesis, respectively, the outer surfaces of which parts ( 1 ) and ( 2 ) are serrated ( 3 ) caused by a plurality of longitudinal and transversal slots constituting small elevated pyramids with their sharp edges. [0018] The inside plane of the upper piece ( 1 ) has an oval-shaped cavity ( 4 ) constituting a union with the lower piece ( 2 ), with threaded orifices ( 5 ) on the periphery and one of the longitudinal sides followed by a smaller diameter cylindrical prolongation which extends to the oval-shaped central cavity, the aforementioned orifices being position from the edge in an oblique arrangement so that the orifices themselves on the inside wall opposite the oval-shaped cavity ( 4 ), are prolonged in the position ( 6 ), permitting the assembly and fastening of the lower piece ( 2 ). [0019] To enable the assembly of the prosthesis, the internal and central plane of the lower part ( 2 ) contains an oval-shaped central protrusion ( 7 ) perfectly adaptable to the cavity ( 4 ) also oval-shaped, of the upper piece ( 1 ), this piece ( 2 ) having in its central protrusion two orifices ( 8 ) arrangement obliquely and in conjunction with the threaded ( 5 ) and blind ( 6 ) orifices to permit the assembly of the blocking bolts ( 9 ) with the sharp point ( 10 ) and the threaded head ( 11 ), thereby fitting both pieces ( 1 ) and ( 2 ) together to form the lumbar prosthesis, the assembly also containing bolt covers ( 12 ) to cover the threaded sector ( 5 ) of the upper piece ( 1 ) of the prosthesis. [0020] Having amply described each and every one of the parts constituting the lumbar disc prosthesis of the invention, all that remains is to note that the different parts can be made from a variety of materials in a variety of shapes and sizes, and the possibility of introducing construction variation, provided that they do not alter the essential aspects of the invention which is the objective of this Utility Model application.

1a

RELATED APPLICATION [0001] This non-provisional application claims priority from provisional application No. 60/368,990, filed on Apr. 2, 2002. FIELD OF INVENTION [0002] This invention relates generally to apparatuses and methods for harvesting produce and, more specifically, to a mobile lettuce harvester adapted to permit the automated harvesting of lettuce heads. BACKGROUND OF THE INVENTION [0003] Generally, the harvesting of produce, including in particular lettuce, involves the manual removal of produce from the field. Typically, a farmworker will walk through a field with a cutting tool such as a knife, and manually detach the exposed lettuce head from its root. The lettuce head will then be delivered for further processing, perhaps to a conveyor belt on a self-propelled harvester travelling through the field alongside the worker. [0004] There are several drawbacks with the prior art methods, however. They are labor-intensive and, because of the use of a sharp cutting implement by the workers, potentially dangerous. A need therefore existed to reduce the labor-intensity of the produce harvesting process, and also to make that process safer. Preferably, account should also be taken of other steps necessary in the harvesting process beyond the removal of the produce from the ground, including inspection, washing, and elevation of the produce to a container. The present invention satisfies this need and provides other, related advantages. SUMMARY OF THE INVENTION [0005] It is an object of the present invention to provide a mobile harvester permitting automated harvesting of produce, including specifically lettuce. [0006] It is a further object of the present invention to provide a mobile harvester permitting automated harvesting of produce, and further having a conveyor belt, a washing station, and an elevator belt. BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS [0007] In accordance with one embodiment of the present invention, a self-propelled harvester is disclosed. The harvester comprises, in BRIEF DESCRIPTION OF THE DRAWINGS [0008] [0008]FIG. 1 is a side view of an embodiment of the lettuce harvesting apparatus of the present invention. [0009] [0009]FIG. 2 is a front view of the lettuce harvesting apparatus of FIG. 1. [0010] [0010]FIG. 3 is a side view of another embodiment of the lettuce harvesting apparatus of the present invention. [0011] [0011]FIG. 4 is a front view of the lettuce harvesting apparatus of the present invention, illustrating in greater detail the bandsaw portion of the apparatus. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0012] Referring first to FIG. 1, an embodiment of the lettuce harvesting apparatus 10 (“apparatus 10 ”) of the present invention is shown. The apparatus 10 is intended to be used for the harvesting of produce. It is preferred to use the apparatus 10 to harvest lettuce, and in particular romaine lettuce. [0013] The major components of the apparatus 10 include a bandsaw 12 , a feed conveyor 14 , a lift conveyor 16 , a washing conveyor 18 , a washing station 20 , a transfer conveyor 22 , and an elevator conveyor 24 . The apparatus 10 is powered by an engine 26 , rides on wheels 28 , and may be driven by a person 29 sitting in driving compartment 30 . [0014] The bandsaw 12 is positioned at the front of the apparatus 10 as shown in FIGS. 1 - 4 . The exposed cutting blade 15 of the bandsaw 12 is positioned at the base of the feed conveyor 14 . The height of the bandsaw 12 and thus of the exposed cutting blade 15 is preferably adjustable, and the desired height setting will depend on the specific produce to be cut. Generally, with romaine, the height of the exposed cutting blade 15 will be set between 0.25″ and 1.5″ from the ground. The level of the bandsaw 12 , and thus of the exposed cutting blade 15 , is preferably also adjustable, as herein described. [0015] Preferably, the bandsaw 12 further comprises a housing 17 , which conceals the cutting blade 15 after it passes across the area where it will be cutting the produce, and continues to loop upward and around. (The path of the cutting blade 15 is illustrated in FIG. 4.) The purpose of the housing 17 is to increase safety for persons who might be working with the apparatus 10 . The bandsaw 12 is preferably powered hydraulically, though of course other powering means may be employed. [0016] The feed conveyor 14 is coupled to the lift conveyor 16 with coupling arms 32 , which coupling arms 32 are to travel in an upward and downward direction about point B, i.e., about the point at which they couple to the lift conveyor 16 . The feed conveyor 14 preferably rides on five parallel rollers 34 (only one is shown), with the rollers 34 being positioned about axle 35 and with axle 35 being coupled at each end thereof to a substantially L-shaped member 37 . Each substantially L-shaped member 37 rotates about point B, and is coupled at its second end (the first end being coupled to axle 35 ) to a hydraulic cylinder 13 (only one of which is shown). (It should be understood that fewer than five, or more than five, rollers 34 could be provided, and further that they could be positioned in a non-parallel configuration.) It is further preferred to position scrapers (not shown) above each roller 34 , oriented so as to remove dirt or debris that adheres to the surface of the rollers 34 as the apparatus 10 travels through a field to be harvested. [0017] The feed conveyor 14 is coupled to the coupling arms 32 with first vertical supports 36 and second vertical supports 38 . The first vertical supports 36 include a spring and shock assembly 40 thereon, so as to permit upward and downward movement of the front portion of the feed conveyor 14 , as indicated by the bi-directional arrow, in response to variations in the terrain over which the apparatus 10 travels. [0018] The second vertical supports 38 are rotatably coupled below the surface of the feed conveyor 14 about point A, which is a centrally-located universal joint. As the front of the feed conveyor moves upward or downward—either by operation of the herein-described height adjustment mechanism or in response to terrain variations—the feed conveyor is permitted to rotate about points A and B. This permits the feed conveyor 14 to remain relatively stable during operation. [0019] The entire feed conveyor 14 preferably maintains a generally upward angle, as indicated in FIG. 1. The belt 42 of the feed conveyor 14 travels in an upward direction, so as to move harvested produce from the front of the feed conveyor 14 upward toward the lift conveyor 16 . [0020] Turning now to the lift conveyor 16 , as shown in FIGS. 1 and 2, it is preferably oriented in an upward direction, when viewed moving backward along the apparatus 10 from the feed conveyor 14 . The feed conveyor 14 is preferably oriented at about a 45 degree angle. The belt 44 of the feed conveyor 14 preferably has a plurality of outwardly projecting steps 46 . The purpose of the steps 46 is to prevent the produce from falling backward as it is moved upward along the lift conveyor 16 . [0021] The lift conveyor 16 is preferably slidably retained on a frame 11 on the main body of the apparatus 10 , and may be raised or lowered along the frame 11 by activation of a hydraulic cylinder (not shown). Raising or lowering of the lift conveyor 16 along the frame 11 will also cause the feed conveyor 14 to be raised or lowered as well, by virtue of the herein-described coupling of the feed conveyor 14 to the lift conveyor 16 . In this manner, it is possible to raise or lower the exposed cutting blade 15 , so as to position it at the desired height for optimum cutting. [0022] For purposes of describing the levelling feature of the apparatus 10 , attention is now drawn to hydraulic cylinders 13 (only one of which is shown), which couple between axle 35 and the substantially L-shaped member 37 . When it is desired to adjust the horizontal level of the exposed cutting blade 15 , typically because of the terrain of the area to be harvested, such levelling can be accomplished by the individual extension or contraction of the hydraulic cylinders 13 , which will have the effect of rotating the substantially L-shaped members 37 about point B and thereby raising or lowering the side of the feed conveyor 14 proximate the activated hydraulic cylinder 13 . [0023] When the produce reaches the topmost point of the lift conveyor 16 , it will pass to the washing conveyor 18 . As the produce moves along the washing conveyor 18 , it will pass through a washing station 20 . Referring now to FIG. 1, the washing station 20 in one embodiment consists of a plurality of spray nozzles 21 located above the washing conveyor 18 , so as to spray water downward onto the produce passing below. Referring now to FIG. 3, the washing station 20 in another embodiment consists of a plurality of spray nozzles 21 located above the washing conveyor 18 and a plurality of spray nozzles 21 located below the washing conveyor 18 . In this embodiment, the produce is sprayed from above and below. (In the embodiment shown in FIG. 3, the belt 48 will need to be configured so as to permit the passage of water therethrough, such as by forming holes in the belt 48 . The water sprayed through the spray nozzles 21 is preferably stored in water tank 50 . [0024] Referring now to FIG. 1, in one embodiment, a portion of the washing conveyor 18 may be left exposed from the top thereof, so as to permit one or preferably two persons 29 to be positioned there. From that position, the persons 29 may inspect the produce as it passes along the washing conveyor 18 , for purposes of quality control. Alternatively, or in combination with the inspection step, one or more persons 29 could remove harvested produce (or a portion of harvested produce—e.g., the heart or the leaves) from the washing conveyor 18 for packaging. (It should be noted that it would also be possible to position the exposed portion after the washing station 20 .) [0025] Referring now to FIG. 3, in one embodiment, a plurality of shaker bars 52 are positioned below the belt 48 , and oriented so that movement of the shaker bars 52 causes shaking of the belt 48 . This shaking movement will cause some of the water remaining on the produce after its passage through washing station 20 to be removed. Referring now to FIGS. 1 and 3, from the end of the washing conveyor 18 , the produce will pass to a transfer conveyor 22 , which is preferably oriented at a right angle to the washing conveyor 18 . The transfer conveyor 22 will move the produce to the elevator conveyor 24 . Like the lift conveyor 16 , the elevator conveyor 24 preferably has a plurality of outwardly projecting steps 46 thereon so as to prevent the produce from falling backward as it travels upward. At the terminus of the elevator conveyor 24 , at exit point B, the produce is dumped into a receptacle (not shown), which may be a truck bed or other suitable vessel. [0026] 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. For example, it may be possible to operate the feed conveyor 14 with the bandsaw 12 as a stand-alone unit, so as to achieve the advantage of automated cutting of the produce—and then performing the washing and loading steps separately. Moreover, the feed conveyor 14 and lift conveyor 16 could be combined into a single conveyor. Still further, it would be possible to eliminate the transfer conveyor 22 , and instead to configure the elevator conveyor 24 in combination with the steps 46 so that produce could pass directly from the washing conveyor 18 to the elevator conveyor 24 without falling backward. Yet further, it would be possible to eliminate both the transfer conveyor 22 and elevator conveyor 24 , with dumping of the produce taking place at the terminus of the washing conveyor 18 .

1a

DESCRIPTION OF THE BACKGROUND Physicians commonly treat blood vessel occlusions by mechanically enhancing blood flow in the affected vessels, such as by employing a stent. Stents act as scaffoldings, physically holding open and, if desired, expanding the wall of affected vessels. Typically, stents can compress for insertion through small lumens via catheters and then expand to a larger diameter once they are positioned. Examples in the patent literature disclosing stents include U.S. Pat. No. 4,733,665 issued to Palmaz, U.S. Pat. No. 4,800,882 issued to Gianturco, and U.S. Pat. No. 4,886,062 issued to Wiktor. Physicians also use stents for providing biological therapy by medicating the stents. Medicated stents allow local administration of a drug. This is preferred because these stents concentrate the drug at a specific site and thus deliver smaller total medication levels in comparison to systemic dosages. One stent medicating method involves using a coating of a polymeric carrier on the stent. Coating comprises immersing the stent in, rolling the material on, applying the material to, or spraying the stent with a material including a solvent, a polymer dissolved in the solvent, and a therapeutic substance dispersed in the solvent. Then the solvent evaporates, leaving a polymer and drug coating. After stent implantation, the stent releases the drug in a sustained manner. U.S. Pat. No. 6,139,573, Sogard et al. teaches an elongated, radially expandable, tubular stent and a polymeric layer covering and conforming to its surface. It teaches laminating a polymeric liner layer and an external polymer layer together to form a composite structure, containing the stent, and at least three domains of distinct porosity. It teaches making the stent from a variety of materials including stainless steel, titanium, platinum, gold, or other biocompatible metals. Furthermore, it teaches that the polymeric layers are expanded polytetrafluoroethylene (ePTFE). In U.S. Pat. No. 6,010,530, Goicoechea teaches a self-expanding stent encapsulated by a skin. The stent contains a continuous, zigzag, nitinol wire wound into several concentric hoops. Its skin is an elastomeric polymer, such as Chronoflex (available from Poly-Medica Biomaterials Inc., Woburn, Mass.). In U.S. Pat. No. 5,749,880, Banas et al. teach an encapsulated stent that comprises at least one stent member concentrically interdisposed between at least two tubular ePTFE extrudates, each of the extrudates have a uniaxial fibril microstructure oriented parallel to the longitudinal axis of the stent. United States Patent Application Publication No. US 2002/0133224 A1 discloses a stent encapsulated with a microporous polymeric membrane. An electrostatic deposition process provides stent encapsulation. Current stents have an overall cylindrical shape with a complex pattern of struts. When placed in the target vessel and expanded, the stent occupies about 10-25% of the vessel wall surface area. Stents are an unusual medical device in that their design is a compromise between mechanical function and biological impact. Skilled Artisans want stents to mechanically support the vessel. This argues for high wall coverage to give good scaffolding, stopping all plague prolapse. But since stents can cause biological responses that precipitate in-stent restenosis, or thrombosis skilled artisans want biologically invisible stents, which tends toward low wall coverage. In addition to non-covered stents, covered stents are also known. Physicians use these devices for certain niche applications. These often serve as bailout devices in cases of severe dissection or perforation of the arterial wall. They are also used to treat aneurysms that may form in the vessel wall from disease or trauma. Their mechanical limitations center on their deliverability and larger profile compared to regular stents. Biological challenges include not only restenosis, but also a higher incidence of thrombotic complications due to the larger surface area of synthetic material. But covered stents could deliver a higher drug payload, and deliver this drug more uniformly to the vessel wall. Between the arterial wall coverage of bare metal stents and that of fully covered stents, lies a continuum in the extent of vessel wall coverage. The best coverage is the minimum amount needed to accomplish the mechanical task without creating adverse biological responses. There is a place for covered stents in interventional cardiology but they still have the following issues: The covering increases the stent profile because it lies on the stent's outer surfaces so it is external to the stent; The covering must expand with the stent; tearing is possible if the covering is not sufficiently elastic; Attachment of the covering to the stent is problematic; insecure attachment can lead to the covering becoming loose or folding over; A covered stent that is too impermeable can completely isolate the underlying endothelium/smooth muscle from its blood supply, which can cause tissue death or necrosis. SUMMARY OF THE INVENTION The current invention can be characterized as having embodiments of methods for making medical devices and devices made from those methods. The devices comprise an implantable portion, with cutouts in the implantable portion that create a lattice structure having sidewalls and a plurality of polymer filaments between the sidewalls or between separate portions of the same sidewall. In some embodiments, the filaments have an average diameter of 0.1 microns to 100 microns, or 0.2 microns to 80 microns, when the device is ready for delivery. In these or other embodiments, the average interfilament spacing is 0.2 microns to 50 microns, or 0.5 microns to 10 microns, when the device is ready for delivery. Different invention embodiments exist in which different portions of the openings formed by the cutouts have different degrees of covering of or blocking of the openings. For example, embodiments in which the polymer filaments block 10-90 percent of the opening formed by the cutout portion are within the scope of the invention, as are embodiments with 20-80 percent or 30-70 percent blockage. In some invention embodiments, the medical device is a stent, such as a self-expanding stent or a balloon expandable stent. The filaments can comprise drug(s), such as anti-proliferative, antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antibiotic, or antioxidant substances, or their combinations. The drug(s) are coated or introduced into or onto the filaments after the filaments are formed or the filaments are prepared from solutions already containing the drug(s). Certain processing parameters are modified to cause filament formation or cobwebbing between the sidewalls of the stent struts. These parameters include the solvent boiling point, the difference between the polymer solubility parameter and the solubility parameter for the trailing solvent, polymer concentration parameter, spray nozzle temperature parameter, drying nozzle temperature parameter, spray flow rate parameter, atomization pressure parameter, spray solution surface-tension parameter, polymer weight average molecular weight parameter, or their combinations. Using solvents of lower boiling point such that the boiling point of the solvent is 25° C. to 165° C. provides an invention embodiment. Alternatively, the solvents boiling point is decreased such that the boiling point of the solvent is 40° C. to 100° C. Other embodiments are provided by each of the following: the difference in the Hildebrand solubility solvation parameter (solubility parameter) between the polymer and the trailing solvent is increased such that the difference in absolute value is 1 to 10 (cal/cm 3 ) 1/2 , or 2 to 6 (cal/cm 3 ) 1/2 . the percent polymer in solution (w/w) is increased such that the solution has a concentration of 1 to 10%, or 2 to 6%. the spray nozzle temperature is increased such that the spray nozzle temperature is 30° C. to 100° C., or 40° C. to 75° C. the dry nozzle temperature is increased such that the dry nozzle temperature is ambient to 140° C., or 40° C. to 100° C. the spray flow rate is increased such that the spray flow rate is 0.1 μg/mm sec to 2 μg/mm sec, or 0.2 μg/mm to 1.5 μg/mm sec. This flow rate is expressed as the μg of coating applied per millimeter of stent length per second. the atomization pressure parameter is increased such that the atomization pressure is 10 psi to 50 psi, or 15 psi to 30 psi. the surface-tension parameter is decreased such that the surface tension of the solution is 15 dyne/cm to 50 dyne/cm, or 18 dyne/cm to 35 dyne/cm. the stent rotation parameter is increased such that the rotation speed of the stent is 10 RPM to 1000 RPM, or 60 RPM to 500 RPM. In some embodiments, the stent is a self-expandable stent in its relaxed state before the coating step. In some embodiments, the stent is a balloon-expandable stent, and the stent is expanded to as large a degree as possible consistent with substantially returning the stent to the unexpanded state before the coating step. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a photograph of a stent coated with a 2% (w/w) Kynar Flex 2800 polymer composition. FIG. 2 is a photograph of a stent coated with a 2% (w/w) Solef 11010 polymer solution. FIG. 3 is another photograph of a stent coated with a Kynar Flex 2800 polymer composition. FIG. 4 is a close-up of the stent of FIG. 3 . FIG. 5 is another close-up of the stent of FIG. 3 . FIG. 6 illustrates a conventional stent. FIG. 7 illustrates an invention device in cross-section. FIG. 8 illustrates an invention device in cross-section. FIG. 9 is a schematic of a prototypical invention process. DETAILED DESCRIPTION In one invention embodiment, a covered stent is formed using a spray process. By appropriately adjusting the spray process parameters, the polymer coating can be made to cobweb between the stent struts. This forms a structure akin to spunbonded, non-woven fabrics. FIG. 1 shows a stent in which fibers of Kynar have been caused to form between the stent struts. Similarly, FIG. 2 shows a stent in which fibers of Solef have been caused to form between the struts. Formation, in part, comes from rejecting standard process parameters, which are specifically chosen to minimize or avoid this cobwebbing effect. A particular configuration for a covered stent and a means to make this construct by a spray process is disclosed. This covered stent is made using the phenomena of cobwebbing with stent coverage. Similar polymers can also be coated in a conformal way, without cobwebbing. Adjusting the process conditions can vary the degree of cobwebbing. One can go from a stent with low coverage to one that is completely covered. At the level of the struts 30 , in FIG. 6 , the coating 35 encapsulates the struts 30 . The polymer strands, filaments, or cobwebs 40 emanate from the sidewalls 45 , FIG. 7 . FIG. 3 illustrates a stent with high coverage of Kynar Flex 2800. FIG. 4 and FIG. 5 show the highly covered Kynar Flex 2800 stent in close-up. Process parameter control can yield very fine polymer-fiber structure. FIG. 6 illustrates a conventional stent 10 formed from a plurality of struts 30 . The plurality of struts 30 are radially expandable and interconnected by connecting elements 14 that are disposed between adjacent struts 30 , leaving lateral openings or cutouts 20 between adjacent struts 30 . Struts 30 and connecting elements 14 define a tubular stent body having an outer, tissue-contacting surface and an inner surface. Although the embodiments of the present invention are described with reference to a stent, the application of the invention should not be limited to a stent and is equally applicable to other implantable medical devices. FIG. 8 shows a stent 10 in cross-section (axial). Cutouts 20 allow passage from the outside of the stent 10 to the inside. Strut 30 is partially surrounded by cutouts 20 , which have sidewalls 45 . Invention coating processes coat the stent 10 in two ways. The conformal coating portion 35 acts as a typical conformal coating. And the webbed coating portion 60 comprises filaments 40 that extend from the conformal coating portion 35 on a sidewall 45 to the conformal coating portion 35 of a separate part of the sidewall 45 or to another sidewall. In some embodiments, filaments 40 are substantially completely further inward than the surface 50 . In some embodiments, filaments 40 occupy 10-90% of the areal space of cutouts 20 . In other embodiments, filaments 40 occupy 20-80%, 30-70%, or 40-60% of the areal space of cutouts 20 . For purposes of this disclosure, areal space is defined as the area of the cutout 20 measured at the surface 50 . If filaments 40 occupy 50% of the areal space of cutouts 20 , this means that filaments 40 block 50% of the space occupied by the cutout. Portions of some embodiments of polymer filaments are less than 1 micron in diameter with interfilament spacings of 1-5 microns. These filaments and spacings are similar to those seen in ePTFE fabrics, which commonly compose stent covers. Generally, polymer filaments average from 0.1 microns to 100 microns; more narrowly, 0.2 microns to 80 microns or 0.5 microns to 20 microns. Also, the interfilament spacing generally averages from 0.2 microns to 50 microns; more narrowly, 0.5 microns to 25 microns or 0.5 microns to 10 microns. Depending on the process parameters, the distribution of filament diameters can range from 0.1 microns to 100 microns, or 0.2 microns to 80 microns, or 0.5 microns to 20 microns. Likewise, the distribution of interfilament spacing can range from 0.2 microns to 50 microns, or 0.5 microns to 25 microns, or 0.5 microns to 10 microns. Both filament diameter and interfilament spacing are measured in the unexpanded, ready-for-delivery state for self-expanding stents. These values are measured in the ready-for-delivery state for balloon expandable stents. “Ready for delivery” means that the medical device is completely manufactured, cleaned, packaged, etc. and could be implanted in a patient. In one embodiment, the stent is coated in a collapsed configuration with the struts nearly touching. On expansion, the polymer between the struts, in this embodiment, is subjected to very high strains. The following methods can be used to reduce this strain. The self-expanding stent can be coated in the expanded state. When collapsed, the mesh covering accordions or folds up. For balloon expandable stents, the stent can be expanded as much as possible and then coated. This will reduce the degree of strain the polymer must accommodate. Methods of Making Current coating processes can create cobwebbing with a variety of polymers. For each material, those of ordinary skill in the art can determine the process parameters necessary for coating a medical device. Examples of categories of such process parameters and useful trends are as follows: Use solvents with higher volatility (this is referred to as a volatility parameter) Use trailing solvents that are poor solvents for the polymer (this is referred to as a solvation parameter) Increase the concentration of the polymer in the solvent (this is referred to as a concentration parameter) Increase the spray nozzle temperature (this is referred to as a spray nozzle parameter) Increase the dry nozzle temperature (this is referred to as a dry nozzle parameter) Increase the flow rate (this is referred to as a flow parameter) Increase the atomization pressure (this is referred to as a atomization pressure parameter) Increase the surface tension of the solution (This is referred to as a surface-tension parameter) Typically, when one spray nozzle is used, the stent is rotated and translated under the spray nozzle to coat all side evenly. In this configuration, one may increase the rotational speed of the stent relative to the spray nozzle. Increasing the stent rotational speed can essentially wind coating solution strands and filaments around the stent. One of ordinary skill in the art recognizes the cumulative effect each of the above parameters has on the process. But for simplicity, each is discussed separately below. By modifying the parameters in one or more categories, a deposition process can be expected to transition from depositing a conformal polymer coating to a cobwebbed polymer coating. Relative terms such as “higher” are referenced against the typical values for the same process parameters in conformal coating processes. Volatility Parameter This parameter relates to the volatility, or boiling point, of the polymer solvent. Increasing the volatility of the solvent system is expected to increase the likelihood that a cobwebbed coating will form. “Solvent” in this case refers to the overall solvent composition, which can be a mixture of individual solvents. Rapid solvent evaporation during spraying leads to an increase in the viscosity of the droplets and coating on the stent. This increases the propensity for the solution to form strands that can interconnect struts. Solvation Parameter This parameter relates to the solubility of the polymer in the trailing solvent. As discussed above, a solvent composition dissolves the polymer for application. Once the polymer solution has been deposited onto the device, solvent begins to evaporate. But the composition of the just-evaporated solvent vapor does not match the composition of the remaining liquid solvent. Some solvent compositions will preferentially evaporate first. This means that, as the solvent evaporates, the composition of the remaining solvent smoothly changes from an initial composition to a final azeotropic composition. (An azeotropic solvent composition naturally evaporates as a single component system; i.e., it has a fixed boiling point and evaporation does not shift the composition of the remaining liquid.) This final composition is typically rich in the solvent component or components that evaporate more slowly. This solvent component, the one that evaporates more slowly than the others, is called a trailing solvent. The solvation power of this trailing solvent may be characterized by the Hildebrand solubility parameter. A solubility parameter may also be arrived at for the coating polymer. When the difference between these two solubility parameters increases, the solubility of the polymer in the solvent lessens. This trend is most applicable when the degree of hydrogen bonding of the solvent and polymer are similar. Typically, this degree of hydrogen bonding is described as high, medium, or low. Consequently, during spraying the more volatile solvent flashes off, and the polymer will tend to gel or precipitate in the trialing solvent. This gelation or precipitation prevents the formation of a smooth coating and can lead to cobwebbing. If the polymer is less soluble in the trailing solvent versus baseline conformal-process trailing solvent, the process with poorer polymer solubility will favor polymer cobwebs. Concentration Parameter This parameter relates to the overall polymer concentration in the solution, usually expressed as percent solids by weight. Higher polymer concentrations versus baseline conformal-process concentrations favor polymer cobwebs. The mechanism is multifold. A higher percent solids leads to a higher solution viscosity. High viscosity solutions do not atomize as effectively into small droplets and strands or filaments can be expressed by the spray nozzle. High viscosity also stabilizes these strands so that they are long lived. Excess fluid coating on the stents surfaces can be blown off during the spray process by the force of the atomizing gas. This can further form stable strands to interconnect struts. Spray Nozzle Temperature Parameter This parameter relates to the temperature of the spray nozzle. Higher spray nozzle temperatures, versus baseline conformal-process temperatures favor polymer cobwebs. As coating solution is passed through the spray nozzle, it is heated to the temperature of the spray nozzle. This is advantageous compared to simply heating all of the coating solution before it enters the nozzle as the exposure time of the coating solution to the elevated temperature is short. At higher temperatures, the atomized coating solution loses solvent more rapidly. This elevates the viscosity of the coating solution favoring stand and cobweb formation. The units are temperature in ° C. of the spray nozzle. Dry Nozzle Parameter This parameter relates to the dry nozzle temperature. Higher dry nozzle temperatures, versus baseline conformal-process temperatures favor polymer cobwebs. When the stent moves from the spray nozzle to the drying nozzle, the action of warm convected gas removes solvent from the stent. This dries the stent and raises the temperature of the stent itself. When the stent is moved under the spray nozzle, the stent coating can absorb move solvent from the solution that is applied. The higher stent temperature also increases the evaporation rate of solvent from the stent. The drying nozzle can also elevate the temperature in the local environment, including that of the spray nozzle. These factors act to increase cobwebbing with increased dry nozzle temperature. The units are temperature in ° C. of the dry nozzle. Flow Parameter This parameter relates to the flow rate of the polymer solution through a spray nozzle for those processes depositing polymer from a spray. Higher flow rates versus baseline conformal-process flow rates can favor polymer cobwebs. High spray flow rates can lead to a stent coating that is very wet. This coating can flow and redistribute on the stent. Often this leads to pool webs that are regions where a continuous polymer film spans the struts at and near strut junctions. A high atomization pressure can blow this excess coating off to form strands that connect struts. The units are expressed in μg of coating applied per millimeter of stent length per second of coating time. Atomization Pressure Parameter This parameter relates to the atomization pressure for those processes depositing polymer from a spray. Higher atomization pressures versus baseline conformal-process atomization pressures favor polymer cobwebs. In spray coating, the atomization serves several purposes. First, it atomizes the solution into droplets. Secondly, it propels these droplets at high velocity towards the stent. And third, it significantly dries both the droplets and the coating during spraying. Drying the droplets to while they are moving towards the stent raises the percent solids of the droplets that, in turn, raise the viscosity. Higher viscosity leads to cobwebbing. Higher atomization pressure also leads to higher atomization gas flow rates and velocities. This high gas velocity past the stent can dislodge wet coating, forming strands in between the struts. In most spray coating equipment, the atomization pressure is proportional to the atomization gas velocity and is a useful indicator for the intensity of the atomization. Units are those of pressure, psi for instance. Surface-Tension Parameter This parameter relates to the surface tension of the polymer solution. Lower solution surface tension versus baseline conformal-process solution surface tensions favor polymer cobwebs. The formation of cobwebs increases the surface area of the polymer coating. A lower surface tension during coating favors formation of more coating surface area. It increases the stability of strands, filaments, and cobwebs while they are still fluid so that they remain after solvent removal. Units on the coating solution are those of surface tension, dyne/cm. Stent Rotation Speed When one spray nozzle is used, the stent rotation speed can effect the formation of cobwebbing. More rapid rotation can serve to wind the formed cobwebs and strands around the stent. Units are revolutions per minute (RPM). One of ordinary skill will recognize that these parameters have a cumulative effect on the polymer's tendency to form cobwebs. Various embodiments comprise modifying any one of or any combination of the volatility, solubility, concentration, spray nozzle, dry nozzle, flow rate, atomization pressure, surface-tension, and rotation parameters in the direction described above to achieve polymer cobwebs. Indeed, any one or any combination of these parameters may be modified towards conformal processes (AWAY from cobweb-forming processes), if the overall deposition behavior yields polymer cobwebs. Furthermore, various embodiments are envisioned in which polymer cobwebs are formed without modifying any one of or any combination of the volatility, solubility, concentration, spray nozzle, dry nozzle, flow rate, atomization pressure, surface-tension, and rotation parameters. A stent with a cobwebbed mesh covering made by a spray process could be used for any stenting indication. There are no limitations on the stent diameter, length, strut pattern, or strut thickness. The stent may be intended for the neurovasculature, carotid, coronary, pulmonary, aorta, renal, biliary, iliac, femoral, popliteal, or other peripheral vasculature. The stent may be balloon expandable or self-expanding. Especially suitable materials include ductile polymers appropriate for permanent in vivo use as coatings. Elast-Eon 2 80A, a silicone urethane, has an ultimate elongation of 520% and is suitable. Other materials include polycarbonate urethanes such as Bionate and Chronoflex, silicone urethanes such as Carbosil and Purasil, polyether urethanes such as Biomer, silicones, fluorosilicates, poly(ethylene-co-vinyl alcohol), poly(ethylene-co-vinyl acetate), poly(butyl methacrylate), poly(methacrylate), poly(acrylates), styrene-ethylene/butylene-styrene triblock copolymers, styrene-isobutylene-styrene triblock copolymers, poly(vinylidene fluoride), poly(vinylidene fluoride-co-hexafluoropropylene), poly(vinylidene fluoride-co-chlorotrifluoroethylene), and solvent soluble fluoropolymers. Ethylene vinyl alcohol copolymer (commonly known by the generic name EVOH or by the trade name EVAL) is functionally a suitable choice of polymer. EVAL adheres well to the surface of a stent, particularly a stainless-steel surface, and expands on a stent without significant copolymer detachment from the surface. Representative examples of polymer families that can be used to coat a medical device in accordance with the present invention include silicone urethanes; ABS resins; acrylic polymers and acrylic copolymers; acrylonitrile-styrene copolymers; alkyd resins; biomolecules; cellulose ethers; celluloses; copoly(ether-esters) (e.g. PEO/PLA); copolymers of polycarboxylic acids and poly-hydroxycarboxylic acids; copolymers of vinyl monomers with each other and olefins; cyanoacrylates; epoxy resins; ethylene vinyl alcohol copolymer; ethylene-methyl methacrylate copolymers; ethylene-vinyl acetate copolymers; ethylene-α-olefin copolymers; fluorosilicates; poly(acrylates); poly(amino acids); poly(anhydrides); poly(ester amides); poly(imino carbonates); poly(iminocarbonate); poly(methacrylates); poly(orthoesters); poly(tyrosine arylates); poly(tyrosine derive carbonates); polyacrylates; polyacrylic acids; polyacrylonitrile; polyalkylene oxalates; polyamides; polyamino acids; polyanhydrides; polycarbonate urethanes; polycarbonates; polycarboxylic acids; polycyanoacrylates; polydioxanones; polyester-amides; polyesters; polyether urethanes; polyethers; poly-hydroxycarboxylic acids; polyimides; polyisobutylene and ethylene-α-olefin copolymers; polyketones; polymethacrylates; polyolefins; polyorthoesters; polyoxymethylenes; polyphosphazenes; polyphosphoester urethanes; polyphosphoesters; polyphosphoesters-urethane; polyurethanes; polyvinyl alcohols; polyvinyl aromatics; polyvinyl esters; polyvinyl ethers; polyvinyl ketones; polyvinylidene halides; silicone urethanes; silicones; solvent-soluble fluoropolymers; starches; styrene-ethylene/butylenes-styrene triblock copolymers; vinyl copolymers vinyl-olefin copolymers; vinyl halide polymers and copolymers. Representative examples of polymers that can be used to coat a medical device in accordance with the present invention include 2-hydroxyethyl methacrylate; 2-hydroxyethyl methacrylate; Biomer; Bionate; Carbosil; carboxymethyl cellulose; cellophane; cellulose; cellulose acetate; cellulose acetate butyrate; cellulose butyrate; cellulose ethers; cellulose nitrate; cellulose propionate; Chronoflex; collagen; Elast-Eon 2 80A; elastin-collagen; ethylene vinyl alcohol copolymer; fibrin; fibrinogen; hyaluronic acid; Nylon 66; poly(3-hydroxy valerate); poly(3-hydroxybutyrate); poly(4-hydroxybutyrate); poly(butyl methacrylate); poly(D,L-lactide); poly(D,L-lactide-co-glycolide); poly(D,L-lactide-co-L-lactide); poly(ethylene-co-vinyl alcohol); poly(glycolic acid); poly(glycolide); poly(hydroxybutyrate); poly(hydroxybutyrate-co-hydroxyvalerate); poly(hydroxybutyrate-co-valerate); poly(hydroxyvalerate); poly(iminocarbonate); poly(lactide-co-glycolide); poly(L-lactic acid); poly(trimethylene carbonate); polyacrylic acid; polyacrylic acid; polyacrylonitrile; polyanhydride; polyanhydride; polycaprolactam; polycaprolactone; polydioxanone; polyethylene glycol; polyisobutylene; polyisocyanate; polyorthoester; polyorthoester; polyphosphoester; polyphosphoester; polyphosphoester urethane; polyphosphoester urethane; polystyrene; polyurethane; polyvinyl acetate; polyvinyl chloride; polyvinyl esters; polyvinyl methyl ether; polyvinyl pyrrolidone; polyvinylidene chloride; polyvinylidene fluoride; Purasil; rayon; rayon-triacetate; sodium alginate; and starch. The polymer coating for use with this invention can comprise a mixture of polymers, such as an intimate mixture of polymer molecules. Biologically active polymers are suitable, as well. In some embodiments, the cobweb forming process operates on polymers or mixtures of polymers comprising a drug that can inhibit vascular, smooth muscle cell activity. Useful drugs for these devices or coatings include any substance capable of exerting a therapeutic or prophylactic effect in the practice of the present invention. The drug(s) can be coated onto the polymer filaments after deposition or can be mixed into the polymer solution before deposition. These bioactive agents can be any agent that is a therapeutic, prophylactic, or diagnostic agent. These agents can have anti-proliferative or anti-inflammatory properties or can have other properties such as antineoplastic, antiplatelet, anti-coagulant, anti-fibrin, anti-thrombonic, antimitotic, antibiotic, antiallergic, antioxidant, as well as cytostatic agents. Examples of suitable therapeutic and prophylactic agents include synthetic inorganic and organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, and DNA and RNA nucleic acid sequences having therapeutic, prophylactic, or diagnostic activities. Nucleic acid sequences include genes, antisense molecules that bind to complementary DNA to inhibit transcription, and ribozymes. Some other examples of other bioactive agents include antibodies, receptor ligands, enzymes, adhesion peptides, blood clotting factors, inhibitors or clot dissolving agents such as streptokinase and tissue plasminogen activator, antigens for immunization, hormones and growth factors, oligonucleotides such as antisense oligonucleotides and ribozymes and retroviral vectors for use in gene therapy. Examples of anti-proliferative agents include rapamycin and its functional or structural derivatives, 40-O-(2-hydroxy)ethyl-rapamycin (everolimus), and its functional or structural derivatives, paclitaxel and its functional and structural derivatives. Examples of rapamycin derivatives include methyl rapamycin (ABT-578), 40-O-(3-hydroxy)propyl-rapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, and 40-O-tetrazole-rapamycin. Examples of paclitaxel derivatives include docetaxel. Examples of antineoplastics and/or antimitotics include methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, doxorubicin hydrochloride (e.g. Adriamycin® from Pharmacia & Upjohn, Peapack N.J.), and mitomycin (e.g. Mutamycin® from Bristol-Myers Squibb Co., Stamford, Conn.). Examples of such antiplatelets, anticoagulants, antifibrin, and antithrombins include sodium heparin, low molecular weight heparins, heparinoids, hirudin, argatroban, forskolin, vapiprost, prostacyclin and prostacyclin analogues, dextran, D-phe-pro-arg-chloromethylketone (synthetic antithrombin), dipyridamole, glycoprotein IIb/IIIa platelet membrane receptor antagonist antibody, recombinant hirudin, thrombin inhibitors such as Angiomax ä (Biogen, Inc., Cambridge, Mass.), calcium channel blockers (such as nifedipine), colchicine, fibroblast growth factor (FGF) antagonists, fish oil (omega 3-fatty acid), histamine antagonists, lovastatin (an inhibitor of HMG-CoA reductase, a cholesterol lowering drug, brand name Mevacor® from Merck & Co., Inc., Whitehouse Station, N.J.), monoclonal antibodies (such as those specific for Platelet-Derived Growth Factor (PDGF) receptors), nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioprotease inhibitors, triazolopyrimidine (a PDGF antagonist), nitric oxide or nitric oxide donors, super oxide dismutases, super oxide dismutase mimetic, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO), estradiol, anticancer agents, dietary supplements such as various vitamins, and a combination thereof. Examples of anti-inflammatory agents including steroidal and non-steroidal anti-inflammatory agents include tacrolimus, dexamethasone, clobetasol, combinations thereof. Examples of such cytostatic substance include angiopeptin, angiotensin converting enzyme inhibitors such as captopril (e.g. Capoten® and Capozide® from Bristol-Myers Squibb Co., Stamford, Conn.), cilazapril, or lisinopril (e.g. Prinivil® and Prinzide® from Merck & Co., Inc., Whitehouse Station, N.J.). An example of an antiallergic agent is permirolast potassium. Other therapeutic substances or agents which may be appropriate include alpha-interferon, bioactive RGD, and genetically engineered epithelial cells. The foregoing substances can also be used in the form of prodrugs or co-drugs thereof. The foregoing substances are listed by way of example and are not meant to be limiting. Other active agents which are currently available or that may be developed in the future are equally applicable. The dosage or concentration of the bioactive agent required to produce a favorable therapeutic effect should be less than the level at which the bioactive agent produces toxic effects and greater than the level at which non-therapeutic results are obtained. The dosage or concentration of the bioactive agent required to inhibit the desired cellular activity of the vascular region can depend upon factors such as the particular circumstances of the patient; the nature of the tissues being delivered to; the nature of the therapy desired; the time over which the ingredient administered resides at the vascular site; and if other active agents are employed, the nature and type of the substance or combination of substances. Therapeutic effective dosages can be determined empirically, for example by infusing vessels from suitable animal model systems and using immunohistochemical, fluorescent or electron microscopy methods to detect the agent and its effects, or by conducting suitable in vitro studies. Standard pharmacological test procedures to determine dosages are understood by one of ordinary skill in the art. Some embodiments choose the drug such that it does not contain at least one of or any combination of antiproliferative, antineoplastic, antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin, antimitotic, antibiotic, or antioxidant substances. Similarly, some invention embodiments choose the drug such that it does not contain one of or any combination of the drugs or drug classes listed above. The coatings and methods of the present invention have been described with reference to a stent, such as a balloon expandable or self-expandable stent. The use of the coating is not limited to stents, however, and the coating can also be used with a variety of other medical devices. Examples of the implantable medical device that can be used in conjunction with the embodiments of this invention include stent-grafts, grafts (e.g., aortic grafts), artificial heart valves, cerebrospinal fluid shunts, pacemaker electrodes, axius coronary shunts and endocardial leads (e.g., FINELINE and ENDOTAK, available from Guidant Corporation). The underlying structure of the device can be of virtually any design. The device can be made of a metallic material or an alloy such as, but not limited to, cobalt-chromium alloys (e.g., ELGILOY), stainless steel (316L), “MP35N,” “MP20N,” ELASTINITE (Nitinol), tantalum, tantalum-based alloys, nickel-titanium alloy, platinum, platinum-based alloys such as, e.g., platinum-iridium alloy, iridium, gold, magnesium, titanium, titanium-based alloys, zirconium-based alloys, or combinations thereof. Devices, such as stents, made from bioabsorbable or biostable polymers can also be used with the embodiments of the present invention. “MP35N” and “MP20N” are trade names for alloys of cobalt, nickel, chromium and molybdenum available from Standard Press Steel Co. of Jenkintown, Pa. “MP35N” consists of 35% cobalt, 35% nickel, 20% chromium, and 10% molybdenum. “MP20N” consists of 50% cobalt, 20% nickel, 20% chromium, and 10% molybdenum. Methods for Coating the Device Using the Composition The following method provides standard conformal polymer coatings. Its parameters should be modified to cause polymer cobwebbing. In some embodiments, at least one of the parameters discussed above is modified in the following process to cause the process to yield cobwebbed polymer. After the structural members of stent 10 are formed from elastic or pseudoelastic metal, biodegradable polymer, durable polymer, or composite material, the polymeric coating can be applied to stent 10 . Various methods can be used to apply the coating such as dipping, roll coating, direct application, wiping, brushing, and spraying. The following application method is provided by way of illustration of a typical process designed to PREVENT cobwebbing and does not limit the present invention. A spray apparatus, such as EFD 780S spray device with VALVEMATE 7040 control system (manufactured by EFD Inc., East Providence, R.I.), can be used to apply a composition to stent 10 . EFD 780S spray device is an air-assisted external mixing atomizer. This atomizes the composition into small droplets and uniformly applies the composition to the stent surfaces. The atomization pressure ranges from about 5 psi to about 20 psi. The droplet size depends on such factors as solution viscosity and surface tension and atomization pressure. Other types of spray applicators, including air-assisted internal mixing atomizers and ultrasonic applicators, can function to apply the composition. Each spraying repetition can be followed by removal of some, most, or all of the solvent(s). Depending on solvent volatility, the solvent can evaporate essentially upon contact with stent 10 . Alternatively, baking the stent at a mild temperature (e.g., 60° C.) for a suitable duration of time (e.g., 2-4 hours) or applying warm air can induce solvent removal. Any suitable number of repetitions can be performed to form a coating of a desired thickness or weight. Exemplary embodiments illustrating ways to modify typical processes are shown below. A polymer composition comprising Kynar Flex 2800 can be dissolved in a solvent system comprising acetone, dioxane, and Techspray at a ratio of 25/50/25 by weight. This solution is applied to a medical device such as a stent by using a spray device such as an EFD 7805 system with VALVEMATE 7040 control system. The atomization pressure ranges from 5 psi to 25 psi. A polymer composition comprising Solef 11010 can be dissolved in a solvent system comprising acetone, dioxane, and Techspray at a ratio of 50/25/25 by weight. This solution is applied to a medical device such as a stent by using a spray device such as an EFD 7805 system with VALVEMATE 7040 control system. The spray nozzle temperature ranges from ambient to 45° C. A polymer composition comprising Solef 21508 can be dissolved in a solvent system comprising acetone/cyclohexanone 90/10 by weight. This solution is applied to a medical device such as a stent by using a spray device such as an EFD 7805 system with VALVEMATE 7040 control system. The dry nozzle temperature ranges from ambient to 55° C. A polymer composition comprising Elast-Eon 2 80A can be dissolved in a solvent system comprising tetrahydrofuran/dimethylacetamide 75/25 by weight. This solution is applied to a medical device such as a stent by using a spray device such as an EFD 7805 system with VALVEMATE 7040 control system. The percent polymer solids in solution ranges from 1% to 6%. A polymer composition comprising Kynar 710 can be dissolved in a solvent system comprising acetone/dimethylacetamide 80/20 by weight. This solution is applied to a medical device such as a stent by using a spray device such as an EFD 7805 system with VALVEMATE 7040 control system. The spray coating weight per pass ranges from 0.14 to 1.4 μg/mm sec. After applying the composition to stent 10 and forming the polymeric coating, stent 10 can be integrated into a stent delivery system. EXAMPLES Example 1 A first composition was prepared by mixing the following components: about 2 mass % Kynar Flex 2800; dissolved in a mixture of acetone, dioxane, and Techspray at a weight ratio of 25/50/25 The first composition was applied onto the surface of a bare 13 mm TETRA stent (available from Guidant Corporation) by spraying and dried to form a cobwebbed stent coating. A spray coater was used, having a 0.014 round nozzle maintained at ambient temperature with a feed pressure of about 0.2 atm (about 3 psi) and an atomization pressure of about 15 psi (about 1.02 atm). The spray nozzle temperature was at ambient and a coating rate of 0.2 μg/mm sec of the wet coating was applied per pass. Between the passes, the coating was dried at using a flow of ambient temperature air for about 10 seconds. A total of 20 passes were applied. Following the last pass, the coating was baked at about 50° C. for about 2 hours. This yielded a cobwebbed, covered stent coating containing about 330 μg of Kynar Flex 2800. Example 2 A first composition was prepared by mixing the following components: about 2 mass % Solef 11010; dissolved in a mixture of acetone, dioxane, and Techspray at a weight ratio of 50/25/25 The first composition was applied onto the surface of a bare 13 mm TETRA stent (available from Guidant Corporation) by spraying and dried to form a cobwebbed stent coating. A spray coater was used, having a 0.014 round nozzle maintained at ambient temperature with a feed pressure of about 0.2 atm (about 3 psi) and an atomization pressure of about 15 psi (about 1.02 atm). The spray nozzle temperature was at ambient and a coating rate of 0.23 μg/mm sec of the wet coating was applied per pass. Between the passes, the coating was dried at using a flow of ambient temperature air for about 10 seconds. A total of 20 passes were applied. Following the last pass, the coating was baked at about 50° C. for about 2 hours. This yielded a cobwebbed, covered stent coating containing about 347 μg of Solef 11010. While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications can be made without departing from the embodiments of this invention in its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as fall within the true spirit and scope of the embodiments of this invention. Additionally, various embodiments have been described above. For convenience's sake, combinations of aspects (such as monomer type or gas flow rate) composing invention embodiments have been listed in such a way that one of ordinary skill in the art may read them exclusive of each other when they are not necessarily intended to be exclusive. But a recitation of an aspect for one embodiment is meant to disclose its use in all embodiments in which that aspect can be incorporated without undue experimentation. In like manner, a recitation of an aspect as composing part of an embodiment is a tacit recognition that a supplementary embodiment exists in which that aspect is specifically excluded.

1a

RELATED APPLICATIONS [0001] The present application is a continuation of application Ser. No. 13/470,715, which was filed on May 14, 2012, now U.S. Pat. No. ______; which in turn is a continuation of application Ser. No. 12/762,772, which was filed on Apr. 19, 2010, now U.S. Pat. No. 8,177,363; which in turn is a continuation of application Ser. No. 11/610,867, which was filed on Dec. 14, 2006, now U.S. Pat. No. 7,699,469; and claims priority from U.S. Provisional Patent Application No. 60/750,045, entitled “System and Method for Tracking Eyeball Motion,” filed Dec. 14, 2005. The contents of these applications are incorporated herein by reference. This application is related to U.S. Provisional Patent Application No. 60/651,989, entitled “Chirped Coherent Laser Radar System and Method,” filed Feb. 14, 2005, the contents of which are also incorporated herein by reference. FIELD OF THE INVENTION [0002] The invention relates generally to tracking the movement of an eyeball, and more particularly to tracking the movement of an eyeball using a detection and ranging system. BACKGROUND OF THE INVENTION [0003] Determining the motion of an eyeball of an individual may have practical application in a multitude of environments. For example, eyeball motion may be monitored in iris and/or corneal recognition systems, stimulus response measurement, medical procedures, virtual reality systems, or other environments. Eyeball motion information may enable improved imaging of the eyeball, iris or retinal. Eyeball motion information may also enable imaging of the eyeball, iris, or cornea at greater ranges than would otherwise be possible. [0004] However, conventional eyeball motion tracking systems, such as stereo systems, may not provide position information related to an eyeball with enough speed and/or accuracy for all of the possible applications of eyeball motion tracking. In general, these systems may also be hampered by an inability to determine position information related to an eyeball from a relatively extended distance. [0005] These and other drawbacks associated with conventional eyeball motion tracking systems and methods exist. SUMMARY [0006] One aspect of the invention relates to detecting position information related to a face, and more particularly to an eyeball in a face, using a detection and ranging system, such as a Radio Detection And Ranging (“RADAR”) system, or a Light Detection And Ranging (“LIDAR”) system. The position information may include a location of the eyeball, translational motion information related to the eyeball (e.g., displacement, velocity, acceleration, jerk, etc.), rotational motion information related to the eyeball (e.g., rotational displacement, rotational velocity, rotational acceleration, etc.) as the eyeball rotates within its socket. One of the advantages of the implementation of a detection and ranging system in detecting position information related to the eyeball may include an increased speed at which the position information may be determined. In fact, in some implementations, the determination of the position information may be substantially instantaneous with substantially no latency. Another advantage of the implementation of a detection and ranging system in detecting position information related to the eyeball may include enabling eyeball motion to be determined from an increased distance and/or with a reduced invasiveness to the individual. [0007] As mentioned above, the detection and ranging system may include a coherent LIDAR system. In these implementations, a first set of electromagnetic radiation beams may be incident on the eyeball at one or more locations on the eyeball. The first set of electromagnetic radiation beams may be returned from these locations on the eyeball to the LIDAR system (e.g., via backscattering, reflection, etc.), and the frequency shift of the returned electromagnetic radiation may be measured. [0008] The coherent LIDAR system may determine information related to one or both of location (e.g., x, y, z) and rotational velocity (e.g., a component of the velocity of the surface of the eyeball that is parallel to an incident electromagnetic radiation beam) at each measurement location on the eyeball. If the radius of the eyeball is known, this information may be determined with three measurement beams focused on three separate measurement locations on the eyeball. If the radius is unknown, the radius may be determined with a fourth measurement beam focused on a fourth separate measurement location on the eyeball. Once the eye has been located (e.g., with three measurement beams if the radius is known or with four measurement beams if the radius is not known), the center of the eye and the closest point of the eye may be determined based on the known location. [0009] At individual ones of the measurement locations, a velocity vector representative of the movement of the eyeball within the eye socket that is tangential to the surface of the eyeball may be determined. If a valid determination of this velocity vector is made for at least two measurement locations on the eyeball that are (i) not the closest point and are (ii) not on the same great circle with each other and the closest point, then the rotational motion of the eyeball within its socket may be determined by the LIDAR system. This may enable the tracking of the lateral rotational motion of the eyeball, and by extension the surface features on the eyeball (e.g., the iris, the pupil, etc.). It should be appreciated that the eyeball may not be formed as a perfect sphere, and that asymmetries in the shape of the eyeball may impact the velocity vector that is calculated at a given measurement location on the eyeball. However, eyeball shape in general is close enough to spherical that typically any non-uniformities in the eyeball may be de minimis and, as such, the eyeball may assumed to be perfectly spherical in some embodiments (and for illustrative purposes herein). [0010] In some implementations, lateral or vertical motion of the face that displaces the eye socket, along with the eyeball, may be determined by video optical flow processing of video footage captured by a video imaging system being used in conjunction with the LIDAR system. Rotation in the plane of the image of the video imaging system may also be determined in this manner. Movement (e.g., displacement, rotation, etc.) of the face out of the plane of the images captured by the video imaging system may be determined by the LIDAR system. For example, a second set of electromagnetic beams may be emitted from the LIDAR system to one or more locations on the face (other than the eyeball), and range and range rate measurements of the one or more locations on the face may be made to determine information related to the movement of the face out of the plane of the images captured by the video imaging system. [0011] The relatively low frequency of head motion and the great number of measurements will allow for a relatively high accuracy of head motion determination in this, or some other, manner. This being done, the location and velocity of the 3D center points of the eyeballs may be determined so that the residual motion of the eyeballs in the eye sockets may be determined separate from the motion of the eye sockets, as if the eyeball were in a stationary socket. [0012] Another aspect of various embodiments of the invention may relate to a laser radar system that unambiguously detects a range of a target and a range rate at which the target is moving relative to the laser radar system. Another aspect of various embodiments of the invention may relate to a laser radar system that uses multiple laser radar sections to obtain multiple simultaneous measurements (or substantially so), whereby both range and range rate can be determined without various temporal effects introduced by systems employing single laser sections taking sequential measurements. In addition, other aspects of various embodiments of the invention may enable faster determination of the range and rate of the target, a more accurate determination of the range and rate of the target, and/or may provide other advantages. [0013] In some embodiments of the invention, the laser radar system may emit a first target beam and a second target beam toward a target. The first target beam and the second target beam may be reflected by the target back toward the laser radar system. The laser radar system may receive the reflected first target beam and second target beam, and may determine at least one of a range of the target from the laser radar system, and a range rate of the target. In some embodiments of the invention, the laser radar system may include a first laser radar section, a second laser radar section, and a processor. [0014] In some embodiments of the invention, the first laser radar section may generate a first target beam and a first reference beam. The first target beam and the first reference beam may be generated by a first laser source at a first frequency that may be modulated at a first chirp rate. The first target beam may be directed toward a measurement point on the target. The first laser radar section may combine one portion of the first target beam that may be directed towards, and reflected from, the target. Another portion of the first target beam, referred to as a local oscillator beam, may be directed over a path with a known or otherwise fixed path length. This may result in a combined first target beam. [0015] According to various embodiments of the invention, the second laser radar section may be collocated and fixed with respect to the first laser radar section. More particularly, the relevant optical components for transmitting and receiving the respective laser beams are collocated and fixed. The second laser radar section may generate a second target beam and a second reference beam. The second target beam and the second reference beam may be generated by a second laser source at a second frequency that may be modulated at a second chirp rate. The second chirp rate may be different from the first chirp rate. This may facilitate one or more aspects of downstream processing, such as, signal discrimination, or other aspects of downstream processing. The second target beam may be directed toward the same measurement point on the target as the first target beam. The second laser radar section may combine one portion of the second target beam that may be directed towards, and reflected from, the target, and another portion of the second target beam that may be directed over a path with a known or otherwise fixed path length. This results in a combined second target beam. [0016] According to various embodiments of the invention, the processor receives the first and second combined target beams and measures a beat frequency caused by a difference in path length between each of the respective reflected target beams and its corresponding local oscillator beam, and by any Doppler frequency shift created by target motion relative to the laser radar system. The beat frequencies may then be combined linearly to generate unambiguous determinations of the range and the range rate of the target, so long as the beat frequencies between each of the respective local oscillator beams and the its reflected target beam correspond to simultaneous (or substantially simultaneous) temporal components of the reflected target beams. Simultaneous (or substantially simultaneous) temporal components of the reflected target beams may include temporal components of the target beams that: 1) have been incident on substantially the same portion of the target, 2) have been impacted by similar transmission effects, 3) have been directed by a scanning optical element under substantially the same conditions, and/or 4) share other similarities. The utilization of beat frequencies that correspond to simultaneous (or substantially simultaneous) temporal components of the reflected target beams for linear combination may effectively cancel any noise introduced into the data by environmental or other effects. [0017] Because the combined target beams may be created by separately combining the first local oscillator beam and the second local oscillator beam with different target beams, or different portions of the same target beam, the first combined target beam and the second combined target beam may represent optical signals that might be present in two separate, but coincident, single source frequency modulated laser radar systems, just prior to final processing. For example, the combined target beams may represent optical signals produced by target interferometers in the single source systems. [0018] According to various embodiments, the target beams may be directed to and/or received from the target on separate optical paths. In some embodiments, these optical paths may be similar but distinct. In other embodiments the first target beam and the second target beam may be coupled prior to emission to create a combined target beam that may be directed toward the target along a common optical path. In some embodiments, the target beam may be reflected by the target and may be received by the laser radar system along a reception optical path separate from the common optical path that directed the target beam toward the target. Such embodiments may be labeled “bistatic.” Or, the combined target beam may be received by the laser radar system along the common optical path. These latter embodiments may be labeled “monostatic.” Monostatic embodiments may provide advantages over their bistatic counterparts when operating with reciprocal optics. More particularly, monostatic embodiments of the invention are less affected by differential Doppler effects and distortion due to speckle, among other things. Differential Doppler effects are created, for example, by a scanning mirror that directs the target beam to different locations on a target. Since different parts of the mirror are moving at different velocities, different parts of the target beam experience different Doppler shifts, which may introduce errors into the range and or range rate measurements. These effects have been investigated and analyzed by Anthony Slotwinski and others, for example, in NASA Langley Contract No. NAS1-18890 (May 1991) Phase II Final Report, Appendix K, submitted by Digital Signal Corporation, 8003 Forbes Place, Springfield, Va. 22131, which is incorporated herein by reference in its entirety. [0019] In some instances, the first laser source and the second laser source may generate electromagnetic radiation at a first carrier frequency and a second carrier frequency, respectively. The first carrier frequency may be substantially the same as the second carrier frequency. This may provide various enhancements to the laser radar system, such as, for example, minimizing distortion due to speckle, or other enhancements. [0020] In some embodiments, the first laser source and the second laser source may provide electromagnetic radiation with highly linearized frequency chirp. To this end, the linearization of the electromagnetic radiation emitted by the first laser source and the second laser source may be calibrated on a frequent basis (e.g. each chirp), or in some embodiments continuously (or substantially so). This linearization the frequency chirp of the electromagnetic radiation may provide enhanced range measurement accuracy, or other enhancements, over conventional systems in which linearization may occur at startup, when an operator notices degraded system performance, when the operator is prompted to initiate linearization based on a potential for degraded performance, or when one or more system parameters fall out of tolerance, etc. Frequent and/or automated linearization may reduce mirror differential Doppler noise effects during high speed scanning and may maximize the effectiveness of dual chirp techniques for canceling out these and other noise contributions to range estimates. [0021] In some embodiments of the invention, the laser radar system may determine the range and the range rate of the target with an increased accuracy when the range of the target from the laser radar system falls within a set of ranges between a minimum range and a maximum range. When the range of the target does not fall within the set of ranges, the accuracy of the laser radar system may be degraded. This degradation may be a result of the coherence length(s) of the first laser source and the second laser source, which is finite in nature. For example, the distance between the minimum range and the maximum range may be a function of the coherence length. The longer the coherence length of the first laser source and the second laser source, the greater the distance between the minimum range and the maximum range. Thus, increasing the coherence length of the first laser source and the second laser source may enhance range and range rate determinations by the laser radar system by providing the ability to make determinations over an enhanced set of ranges. [0022] In some embodiments of the invention, one or both of the first laser source and the second laser source may implement a system and method for controllably chirping electromagnetic radiation from a radiation source. The system and method may enable electromagnetic radiation to be produced at a substantially linear chirp rate with a configurable period. In some embodiments, the radiation may include a single, frequency shifted, resonant mode. [0023] In some embodiments of the invention, a system may include a radiation source, one or more optical elements that form an optical cavity, a frequency shifter, an optical switch and an optical amplifier. In some embodiments, the frequency shifter may be disposed within the optical cavity to receive electromagnetic radiation from the optical cavity, and to output a frequency shifted portion of the received electromagnetic radiation back to the optical cavity. The optical switch may be disposed within the optical cavity to receive electromagnetic radiation from the optical cavity. The optical switch may be controllable to either direct the received electromagnetic radiation away from the optical cavity, or to return the received electromagnetic radiation back to the optical cavity. In some instances, the optical switch may be controllable to couple radiation from the radiation source to the optical cavity while directing the received electromagnetic radiation away from the optical cavity, the radiation from the source being received at the optical switch at an initial frequency. [0024] According to various embodiments of the invention, the optical cavity may be “filled” by directing radiation from the laser source, emitted at the initial frequency, into the optical cavity for a period of time that corresponds to the optical length of the optical cavity. In some embodiments, the radiation from the laser source may be directed into the optical cavity by the optical switch. While the electromagnetic radiation from the laser source is being directed in to the cavity, the optical switch may be controlled to direct radiation received by the optical switch away from the optical cavity, or “dumped” from the cavity. Once the cavity is “filled” (e.g., after the time period corresponding to the optical length of the optical cavity has passed) the flow of radiation from the laser source to the optical cavity may be halted. In some embodiment, the flow of radiation from the laser source to the optical cavity may be halted by powering down the laser source. In other embodiments, the flow of radiation from the laser source to the optical cavity may be halted by controlling the optical switch to dump the radiation from the laser source away from the optical cavity. The radiation injected into the optical cavity while the cavity was being filled, may be circulated within the cavity by the optical switch, which may be controlled to direct radiation received from the optical cavity back into the optical cavity. [0025] In some embodiments of the invention, as the electromagnetic radiation is circulated within the optical cavity, the frequency of the radiation may be incrementally adjusted by the frequency shifter during each trip around the optical cavity. Through this periodic, incremental adjustment, the frequency of the radiation within the optical cavity may be chirped in a substantially linear manner. The rate at which the frequency of the electromagnetic radiation is chirped may be related to one or both of the incremental frequency adjustment applied by the frequency shifter and the optical length of the cavity. Thus, the rate at which the frequency of the radiation is chirped, may be controlled via one or both of these variables. [0026] In some embodiments, a quality factor of the optical cavity may be degraded by various losses within the optical cavity. For example, radiation output from the optical cavity to a device may constitute a loss. Other losses may also be present, such as losses due to imperfections in the optical elements, or other parasitic losses. To combat the degradation of the quality factor, an optical amplifier may be disposed within the optical cavity. The optical amplifier may be selected or controlled to provide enough gain to radiation within the optical cavity to overcome the sum of the cavity losses so that a predetermined or controlled intensity of radiation output from the optical cavity may be maintained. The optical amplifier may also be selected based on one or more other characteristics, such as, for example, homogeneous line width, gain bandwidth, or other specifications. [0027] In some embodiments of the invention, one of the chirp rates may be set equal to zero. In other words, one of the laser sources may emit radiation at a constant frequency. This may enable the laser source emitting at a constant frequency to be implemented with a simpler design, a small footprint, a lighter weight, a decreased cost, or other enhancements that may provide advantages to the overall system. In these embodiments, the laser radar section with chirp rate set equal to zero may be used to determine only the range rate of the target. [0028] In some embodiments of the invention, the processor may linearly combine the first combined target beam and the second combined target beam digitally to generate the range signal and the range rate signal. For example, the processor may include a first detector and a second detector. The first detector may receive the first combined target beam and may generate a first analog signal that corresponds to the first combined target beam. The first analog signal may be converted to a first digital signal by a first converter. The processor may include a first frequency data module that may determine a first set of frequency data that corresponds to one or more frequency components of the first digital signal. [0029] The second detector may receive the second combined target beam and may generate a second analog signal that corresponds to the second combined target beam. The second analog signal may be converted to a second digital signal by a second converter. The processor may include a second frequency data module that may determine a second set of frequency data that corresponds to one or more of frequency components of the second digital signal. [0030] The first set of frequency data and the second set of frequency data may be received by a frequency data combination module. The frequency data combination module may generate a range rate signal and a range signal derived from the first set of frequency data and the second set of frequency data. [0031] In other embodiments of the invention, the processor may mix the first combined target beam and the second combined target beam electronically to generate the range signal and the range rate signal. For example, the processor may include a modulator. The modulator may multiply the first analog signal generated by the first detector and the second analog signal generated by the second detector to create a combined analog signal. In such embodiments, the processor may include a first filter and a second filter that receive the combined analog signal. The first filter may filter the combined analog signal to generate a first filtered signal. The first filtered signal may be converted by a first converter to generate a range rate signal. The second filter may filter the combined analog signal to generate a second filtered signal. The second filtered signal may be converted by a second converter to generate a range signal. [0032] According to other embodiments of the invention, the processor may mix the first combined target beam and the second combined target beam optically to generate the range signal and the range rate signal. For example, the processor may include a detector that receives the first combined target beam and the second combined target beam and generates a combined analog signal based on the detection of the first combined target beam and the second combined target beam. In such embodiments, the processor may include a first filter and a second filter that receive the combined analog signal. The first filter may filter the combined analog signal to generate a first filtered signal. The first filtered signal may be converted by a first converter to generate a range rate signal. The second filter may filter the combined analog signal to generate a second filtered signal. The second filtered signal may be converted by a second converter to generate a range signal. [0033] These and other objects, features, and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. As used in the specification and in the claims, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. BRIEF DESCRIPTION OF THE DRAWINGS [0034] FIG. 1 illustrates a system for monitoring motion of an eyeball of an individual according to one or more embodiments of the invention. [0035] FIG. 2 illustrates a laser radar system that may be implemented in the system for monitoring an eyeball of an individual according to one or more embodiments of the invention. [0036] FIG. 3 illustrates a laser radar system that may be implemented in the system for monitoring an eyeball of individual according to one or more embodiments of the invention. [0037] FIG. 4 illustrates a processor that digitally mixes two combined target beams according to one or more embodiments of the invention. [0038] FIG. 5 illustrates a processor that electrically mixes two combined target beams according to one or more embodiments of the invention. [0039] FIG. 6 illustrates a processor that optically mixes two combined target beams according to one or more embodiments of the invention. DETAILED DESCRIPTION [0040] FIG. 1 is an exemplary illustration of a system 110 for detecting position information related to a face, and more particularly to an eyeball in a face of an individual 112 , in accordance with some embodiments of the invention. System 110 may determine position information related to the eyeball of individual 112 . System 110 may include a laser radar system 116 capable of determining a range to and/or a range rate (i.e., velocity) of a point on a surface of individual 112 (e.g., skin, clothing, lips, etc.). System 110 may include a monitor module 118 capable of determining position information related to the eyeball of individual 112 based on the determinations of laser radar system 116 . System 110 may enable the position information related to the eyeball of individual 112 to be monitored and determined remotely from individual 112 without directly contacting individual 112 . [0041] In some embodiments of the invention, laser radar system 116 may direct a beam of electromagnetic radiation 114 toward individual 112 to be incident on individual 112 at a point on the surface of individual 112 to be measured. Some or all of radiation 114 directed to the point on the surface of individual 112 may be reflected by the surface, and may then be received back into laser radar system 116 . As described below, based on one or more aspects of radiation 114 (e.g., frequency, phase, intensity, etc.) prior to emission and/or subsequent to reflection, laser radar system 116 may determine one or both of the range and the range rate of the point on the surface with respect to laser radar system 116 . [0042] According to various embodiments of the invention, laser radar system 116 may make a plurality of determinations of range and/or range rate of a set of measurement points on a surface of the eyeball of individual 112 (e.g., at a periodic rate) over a period of time. Monitor module 118 may implement the determined ranges and range rates to determine the position information related to the eyeball. [0043] According to various embodiments of the invention, monitor module 118 may additionally monitor movement of the head of individual 112 , in order to more accurately determine position information related to the eyeball of individual 112 . In some of these embodiments, system 110 may include a video imaging system that captured video footage (successive images) of individual 112 . Lateral or vertical motion of the face of individual 112 (in the plane of the images captured by the video imaging system) that displaces the eye socket, along with the eyeball, may be determined by video optical flow processing (or some other motion tracking processing) of the video footage captured by the video imaging system. Similarly, the rotation of the face of individual 112 within the image plane may be determined. In this way, three degrees of motion may be measured by the video imaging system. This optical flow processing may be performed by monitor module 118 . Motion of the face of individual 112 out of the plane of the images captured by the video imaging system may be determined by taking measurements of the face (outside of the eye sockets) by laser radar system 116 . These motions comprise range motion (a translational degree of freedom) and the two rotational degrees of freedom that are orthogonal to the image plane of the video imaging system. Thus, by combining the information determined from the video footage captured by the video imaging system and the measurements of laser radar system 116 , monitor module 118 may determine the motion of the face of individual 112 in six degrees of freedom. [0044] By determining the motion of the face of individual 112 , monitor module 118 may track the motion and/or position of the eye socket of individual 112 . Monitor module 118 may adjust determinations of the position and/or movement of the eyeball of individual 112 , using the motion and/or position of the eye socket of individual 112 , to reflect only (or substantially only) the rotation of the eyeball in the eye socket. [0045] FIG. 2 illustrates a frequency modulated laser radar system 210 that may be implemented within system 110 as laser radar system 116 , according to some embodiments of the invention. System 210 may include a laser source 212 that emits a beam 214 of electromagnetic radiation. Beam 214 may be emitted at a frequency that is continuously varied, or chirped. In some instances, chirping the frequency may include sweeping the frequency between a lower frequency and an upper frequency (or vice versa) in a periodic manner (e.g. a sawtooth waveform, a triangle waveform, etc.). Beam 214 may be divided by an optical coupler 216 into a target beam 218 and a reference beam 220 . It should be appreciated that although laser radar system 210 is shown and described as a single beam system, that in order to provide beams of electromagnetic radiation to a plurality of points on the eyeball of the individual beam 214 may be divided into a plurality of beams, and each beam may then be subsequently processed in the manner described below. [0046] In conventional embodiments, system 210 may include a target interferometer 222 and a reference interferometer 224 . Target interferometer 222 may receive target beam 218 , and may divide the target beam at an optical coupler 226 . Target interferometer 222 is typically used to generate a target signal that may depend upon a range of a target 230 (e.g. individual 112 ) from target interferometer 222 . Target interferometer may accomplish this by directing one portion 228 of target beam 218 toward target 230 , and the other portion 232 of target beam 218 to a target frequency difference module 234 over an optical path with a fixed path length. Portion 228 of target beam 218 may be reflected by target 230 and may be transmitted to target frequency difference module 234 via optical coupler 226 and an optical fiber 236 . Based on interference between portions 236 and 232 at coupler 248 , target frequency difference module 234 may generate the target signal corresponding to a beat frequency of portions 236 and 232 of target beam 218 due to the difference between their path lengths. [0047] According to various embodiments of the invention, reference interferometer 224 may receive reference beam 220 and may generate a reference signal corresponding to a frequency difference between two portions of reference beam 224 that may be directed over two separate fixed paths with a known path length difference. More particularly, reference beam 220 may be divided by an optical coupler 240 into a first portion 242 and a second portion 244 . First portion 242 may have a fixed optical path length difference relative to second portion 244 . Based on interference between portions 242 and 244 at coupler 246 , reference frequency difference module 250 may generate the reference signal corresponding to a beat frequency of portions 242 and 244 of reference beam 220 caused by the fixed difference between their path lengths. [0048] As will be appreciated, target interferometer 222 and reference interferometer 224 have been illustrated and described as Mach-Zehnder interferometers. However other interferometer configurations may be utilized. For example, target interferometer 222 and reference interferometer 224 may include embodiments wherein Michelson-Morley interferometers may be formed. [0049] In some embodiments, system 210 may include a processor 238 . Processor 238 may receive the target signal and the reference signal and may process these signals to determine the range of target 230 . Range information determined based on the target signal and the reference signal may be used to determine a range rate of target 230 with respect to target interferometer 222 . [0050] FIG. 3 illustrates an exemplary embodiment of a laser radar system 310 that may be implemented within system 110 , as laser radar system 116 , to monitor one or more points on a surface of the eyeball of individual 112 , according to some embodiments of the invention. Laser radar system 310 may employ two or more laser radar sections, each of which emits a target beam of radiation toward a target. For example, a first laser radar section 374 emits a first target beam 312 and a second laser radar section 376 emits a second target beam 314 toward a target 316 (e.g., individual 112 ). In some embodiments of the invention, first target beam 312 and second target beam 314 may be chirped to create a dual chirp system. The implementation of laser radar system 310 in system 110 to monitor one or more points on a surface of the eyeball of individual 112 may provide unambiguous determinations of the range and the range rate of the points on the surface of the eyeball of individual 112 with respect to system 110 , and may enable enhanced determinations of position information related to the eyeball of individual 112 by monitoring module 118 . For example, the unambiguous determination of the range and/or the range rate of the points on the surface of the eyeball of individual 112 may reduce an amount of noise in the determined ranges and/or range rates. If present, the noise may impact the accuracy of the determinations of the ranges and/or range rates. Inaccuracies within the determined ranges and/or range rates may hamper determinations that leverage the determined ranges and/or range rates to position information related to the eyeball of individual 112 . [0051] It should be appreciated that although laser radar system 310 is shown and described as a dual beam system that provides two beams incident on a single point, that this description is not limiting and that in order to provide monitor a plurality of points on the eyeball each of the target beams may be divided into a plurality of beams, and each beam may then be subsequently processed in the manner described below. In some implementations, the plurality of points on the eyeball may be monitored by successively by the single point radiation (e.g., by scanning the single point of radiation to each of the plurality of points on the eyeball in succession). Although in these implementations the points on the eyeball may not be monitored absolutely simultaneously, the single point radiation may be provided to each of the plurality of points on the eyeball quickly enough that the resulting collection of data may be processed as if the plurality of points had been monitored simultaneously. In some implementations, a hybrid approach may be implemented in which the beams provided by laser radar system 310 as a single point of radiation may be divided to provide a plurality of points of radiation, and each of the plurality of points of radiation may be scanned successively to different points on the eyeball (and/or individual 112 ). [0052] According to various embodiments of the invention, laser section 374 may include a laser source controller 336 , a first laser source 318 , a first optical coupler 322 , a first beam delay 344 , a first local oscillator optical coupler 330 , and/or other components. Second laser radar section 376 may include a laser source controller 338 , a second laser source 320 , a second optical coupler 324 , a second beam delay 350 , a second local oscillator optical coupler 332 and/or other components. For example, some or all of the components of each of laser radar sections 374 and 376 may be obtained as a coherent laser radar system from Metris USA. Coherent laser radar systems from Metris USA may provide various advantages, such as enhanced linearity functionality, enhanced phase wandering correction, and other advantages to laser radar system 310 in determining the range and the range rate of target 316 . [0053] In some embodiments of the invention, first target beam 312 and second target beam 314 may be reflected by target 316 back toward laser radar system 310 . Laser radar system 310 may receive first target beam 312 and second target beam 314 , and may determine at least one of a range of target 316 from laser radar system 310 , and a range rate of target 316 . [0054] According to various embodiments of the invention, first laser source 318 may have a first carrier frequency. First laser source 318 may emit a first laser beam 340 at a first frequency. The first frequency may be modulated at a first chirp rate. The first frequency may be modulated electrically, mechanically, acousto-optically, or otherwise modulated as would be apparent. First laser beam 340 may be divided by first optical coupler 322 into first target beam 312 and a first local oscillator beam 342 . First local oscillator beam 342 may be held for a first delay period at a first beam delay 344 . [0055] In some embodiments of the invention, second laser source 320 may emit a second laser beam 346 at a second frequency. The second frequency may be modulated at a second chirp rate different from the first chirp rate. The second frequency may be modulated electrically, mechanically, acousto-optically, or otherwise modulated. The first chirp rate and the second chirp rate may create a counter chirp between first laser beam 340 and second laser beam 346 . [0056] In some instances, the second carrier frequency may be substantially the same as the first carrier frequency. For example, in some embodiments the percentage difference between the first baseline frequency and the second baseline frequency is less than 0.05%. This may provide various enhancements to laser system 310 , such as, for example, minimizing distortion due to speckle, or other enhancements. Second laser beam 346 may be divided by second optical coupler 324 into a second target beam 314 and a second local oscillator beam 348 . Second local oscillator beam 348 may be held for a second delay period at a second beam delay 350 . The second delay period may be different than the first delay period. [0057] In some embodiments, the output(s) of first laser source 318 and/or second laser source 320 (e.g. first laser beam 340 and/or second laser beam 346 ) may be linearized using mechanisms provided in, for example, Metris USA Model MV200. Phase wandering of the output(s) of first laser source 318 and/or second laser source 320 may be corrected using mechanisms provided in, for instance, Metris USA Model MV200. [0058] In some embodiments of the invention, laser radar system 310 may determine the range and the range rate of target 316 with an increased accuracy when the range of target 316 from laser radar system 310 falls within a set of ranges between a minimum range and a maximum range. When the range of target 316 does not fall within the set of ranges, the accuracy of laser radar system 310 may be degraded. [0059] According to various embodiments of the invention, first beam delay 344 and second beam delay 350 may be adjustable. Adjusting first beam delay 344 and second beam delay 350 may enable laser radar system 310 to be adjusted to bring the set of ranges over which more accurate determinations may be made closer to, or further away from, laser radar system 310 . First beam delay 344 and the second beam delay 350 may be adjusted to ensure that the range of target 316 falls within the set of ranges between the minimum range and the maximum range so that the range and the range rate of target 316 may be determined accurately. First beam delay 344 and second beam delay 350 may be adjusted by a user, or in an automated manner. [0060] The degradation of determinations of range and range rate when the range of target 316 is outside of the set of ranges may be a result of the finite nature of the coherence length of first laser source 318 and second laser source 320 . For example, the distance between the minimum range and the maximum range may be a function of the coherence length. The longer the coherence length of first laser source 318 and second laser source 320 , the greater the distance between the minimum range and the maximum range may be. Thus, increasing the coherence length of first laser source 318 and second laser source 320 may enhance range and range rate determinations by laser radar system 310 by providing the ability to make determinations over an enhanced set of ranges. [0061] In some embodiments of the invention, first local oscillator beam 342 may be divided into a plurality of first local oscillator beams and second local oscillator beam 348 may be divided into a plurality of second local oscillator beams. In such instances, laser radar system 310 may include a plurality of beam delays that may apply delays of varying delay periods to the plurality of first local oscillator beams and the plurality of second local oscillator beams. This may ensure that one of the plurality of first local oscillator beams and one of the plurality of second local oscillator beams may have been delayed for delay periods that may enable the range and range rate of the target to be determined accurately. [0062] Accordingly, in some embodiments of the invention, first laser source 318 and second laser source 320 may emit chirped electromagnetic radiation with an enhanced coherence length. For example, first laser source 318 and/or second laser source 320 may include system 310 as illustrated in FIG. 3 and described above. [0063] According to various embodiments, first target beam 312 and second target beam 314 may be directed and/or received from target 316 on separate optical paths. In some embodiments, these optical paths may be similar but distinct. In other embodiments, first target beam 312 and second target beam 314 may be coupled by a target optical coupler 326 into a combined target beam 352 prior to emission that may be directed toward target 316 along a common optical path. In some embodiments, combined target beam 352 (or first target beam 312 and second target beam 314 , if directed toward target 316 separately) may be reflected by target 316 and may be received by laser radar system 310 along a reception optical path separate from the common optical path that directed combined target beam 352 toward target 316 . Such embodiments may be labeled “bistatic.” Or, combined target beam 352 may be received by laser radar system 310 as a reflected target beam 356 along the common optical path. These latter embodiments may be labeled “monostatic.” Monostatic embodiments may provide advantages over their bistatic counterparts when operating with reciprocal optics. In monostatic embodiments, the common optical path may include optical member 328 that may provide a common port for emitting combined target beam 352 and receiving reflected target beam 356 . Optical member 328 may include an optical circulator, an optical coupler or other optical member as would be apparent. [0064] In some embodiments, the common optical path may include a scanning element 337 . Scanning element 337 may include an optical element such as, for instance, a mirror, a lens, an antenna, or other optical elements that may be oscillated, rotated, or otherwise actuated to enable combined target beam 352 to scan target 316 . In some instances, scanning element 337 may enable scanning at high speeds. In conventional systems, scanning elements may be a source of mirror differential Doppler noise effects due to speckle or other optical effects that may degrade the accuracy of these systems. However, because various embodiments of laser radar system 310 use simultaneous measurements (or substantially so) to unambiguously determine range and range rate, inaccuracies otherwise induced by high speed scanning may be avoided. [0065] In some embodiments of the invention, a target optical coupler 354 may divide reflected target beam 356 into a first reflected target beam portion 358 and a second reflected target beam portion 360 . First local oscillator optical coupler 330 may combine first local oscillator beam 342 with first reflected target beam portion 358 into a first combined target beam 362 . Second local oscillator optical coupler 332 may combine second local oscillator beam 348 with second reflected target beam portion 360 into a second combined target beam 364 . In some embodiments not shown in the drawings, where, for example first target beam 312 and second target beam 314 may be directed to and/or received from target 316 separately, first local oscillator optical coupler 330 may combine first target beam 312 that is reflected with first local oscillator beam 342 to create first combined target beam 362 , and second target beam 314 that is reflected may be combined with second local oscillator beam 348 to create second combined target beam 364 . [0066] Because first local oscillator beam 342 and second local oscillator beam 348 may be combined with different target beams, or different portions of the same target beam (e.g. reflected target beam 356 ), first combined target beam 362 and second combined target beam 364 may represent optical signals that might be present in two separate, but coincident, single laser source frequency modulated laser radar systems, just prior to final processing. For example, laser source controller 336 , first laser source 318 , first optical coupler 322 , first beam delay 344 , and first local oscillator optical coupler 330 may be viewed as a first laser radar section 374 that may generate first combined target beam 362 separate from second combined target beam 364 that may be generated by a second laser radar section 376 . Second laser radar section 376 may include laser source controller 338 , second laser source 320 , second optical coupler 324 , second beam delay 350 , and second local oscillator optical coupler 332 . [0067] In some embodiments, laser radar system 310 may include a processor 334 . Processor 334 may include a detection module 366 , a mixing module 368 , a processing module 370 , and/or other modules. The modules may be implemented in hardware (including optical and detection components), software, firmware, or a combination of hardware, software, and/or firmware. Processor 334 may receive first combined target beam 362 and second combined target beam 364 . Based on first combined target beam 362 and second combined target beam 364 , processor 334 may generate the range signal and the range rate signal. Based on the range signal and the range rate signal, the range and the range rate of target 316 may be unambiguously determined. [0068] In some embodiments of the invention, processor 334 may determine a first beat frequency of first combined local oscillator beam 362 . The first beat frequency may include a difference in frequency, attributable to a difference in path length, of first local oscillator beam 342 and the component of reflected target beam 356 that corresponds to first target beam 312 that has been reflected from target 316 . Processor 334 may determine a second beat frequency of second combined local oscillator beam 364 . The second beat frequency may include a difference in frequency, attributable to a difference in path length, of second local oscillator beam 348 and the component of reflected target beam 356 that corresponds to second target beam 314 that has been reflected from target 316 . The first beat frequency and the second beat frequency may be determined simultaneously (or substantially so) to cancel noise introduced by environmental or other effects. One or more steps may be taken to enable the first beat frequency and the second beat frequency to be distinguished from other frequency components within first combined target beam 362 , other frequency components within second combined target beam 364 , and/or each other. For example, these measures may include using two separate chirp rates as the first chirp rate and the second chirp rate, delaying first local oscillator beam 342 and second local oscillator beam 350 for different delay times at first beam delay 344 and second beam delay 350 , respectively, or other measures may be taken. [0069] It will be appreciated that while FIG. 3 illustrates an exemplary embodiment of the invention implemented primarily using optical fibers and optical couplers, this embodiment is in no way intended to be limiting. Alternate embodiments within the scope of the invention exist in which other optical elements such as, for example, prisms, mirrors, half-mirrors, beam splitters, dichroic films, dichroic prisms, lenses, or other optical elements may be used to direct, combine, direct, focus, diffuse, amplify, or otherwise process electromagnetic radiation. [0070] According to various embodiments of the invention, processor 334 may mix first combined target beam 362 and second combined target beam 364 to produce a mixed signal. The mixed signal may include a beat frequency sum component that may correspond to the sum of the first beat frequency and the second beat frequency, and a beat frequency difference component that may correspond to the difference between the first beat frequency and the second beat frequency. For a target having constant velocity, first laser beam 340 and second laser beam 346 beat frequencies may be described as follows: [0000] f 1  ( t ) = 4  π   v λ 1 + 2  π   γ 1  ( R - RO 1 ) , and ( 1 ) f 2  ( t ) = 4  π   v λ 2 + 2  π   γ 2  ( R - RO 2 ) , respectively , ( 2 ) [0000] where f 1 (t) represents the first beat frequency, f 2 (t) represents the second beat frequency, λ 1 and λ 2 are the two optical wavelengths, v is the target velocity, γ 1 and γ 2 are proportional to the respective chirp rates, R is the measured range and RO 1 and RO 2 represent the range offsets for the two laser radars. Now assume that λ 1 =λ 2 =λ. We may subtract the equations to yield [0000] f 1 ( t )− f 2 ( t )=2 πR (γ 1 −γ 2 )−2π(γ 1 RO 1 −γ 2 RO 2 )  (3) [0000] Rearranging (3) we obtain [0000] R = ( f 1  ( t ) - f 2  ( t ) ) 2  π  ( γ 1 - γ 2 ) + ( γ 1  RO 1 - γ 2  RO 2 ) ( γ 1 - γ 2 ) ( 4 ) [0000] as the corrected range measurement. Similarly we may combine (1) and (2) to obtain the expression, [0000] v = λ 4  π  ( f 1  ( t ) - γ 1 γ 2   f 2  ( t ) 1 - γ 1 γ 2 ) + λ   γ 1 2  ( RO 1 - RO 2 1 - γ 1 γ 2  ) , ( 5 ) [0000] which provides a measure of the target velocity. [0071] According to various embodiments of the invention, the beat frequency sum component, described above in Equation 4, may be filtered from the mixed signal to produce a range signal. From the beat frequency sum component included in the range signal (e.g. f 1 ( t )+f 2 ( t )), a determination of the distance from laser radar system 310 to target 316 may be made. The determination based on the range signal may be unambiguous, and may not depend on either the instantaneous behavior, or the average behavior of the Doppler frequency shift (e.g. v/λ). [0072] In some embodiments, the beat frequency difference component, described above in Equation 4, may be filtered from the mixed signal to produce a range rate signal. From the beat frequency difference component included in the range rate signal, a determination of the range rate of target 316 may be unambiguously made. To determine the range rate of target 316 , [0000] f 1  ( t ) - γ 1 γ 2  f 2   ( t ) [0000] may be represented as a value proportional to a chirp rate difference between the first chirp rate and the second chirp rate. This may enable the Doppler shift information to be extracted, which may represent an instantaneous velocity (i.e., range rate) of target 316 . [0073] In some embodiments of the invention, the second chirp rate may be set to zero. In other words, second laser source 318 may emit radiation at a constant frequency. This may enable second laser source 318 to be implemented with a simpler design, a small footprint, a lighter weight, a decreased cost, or other enhancements that may provide advantages to the overall system. In such embodiments, laser radar system 310 may include a frequency shifting device. The frequency shifting device may include an acousto-optical modulator 372 , or other device. Acousto-optical modulator 372 may provide a frequency offset to second local oscillator beam 348 , which may enhance downstream processing. For example, the frequency offset may enable a stationary target beat frequency between second local oscillator beam 348 and second reflected target beam portion 360 representative of a range rate of a stationary target to be offset from zero so that the a direction of the target's movement, as well as a magnitude of the rate of the movement, may be determined from the beat frequency. This embodiment of the invention has the further advantage that it may allow for continuous monitoring of the target range rate, uninterrupted by chirp turn-around or fly-back. Chirp turn-around or fly-back may create time intervals during which accurate measurements may be impossible for a chirped laser radar section. In these embodiments, laser radar section 376 may only determine the range rate of target 316 while laser radar system 310 retains the ability to measure both range and range rate. [0074] FIG. 4 illustrates a processor 334 according to one embodiment of the invention. Processor 334 may mix first combined target beam 362 and second combined target beam 364 digitally. For example, processor 334 may include a first detector 410 and a second detector 412 . The first detector 410 may receive first combined target beam 362 and may generate a first analog signal that corresponds to first combined target beam 362 . The first analog signal may be converted to a first digital signal by a first converter 414 . Processor 334 may include a first frequency data module 416 that may determine a first set of frequency data that corresponds to one or more frequency components of the first digital signal. In some instances, the first digital signal may be averaged at a first averager module 418 . In such instances, the averaged first digital signal may then be transmitted to first frequency data module 416 . [0075] Second detector 412 may receive second combined target beam 364 and may generate a second analog signal that corresponds to second combined target beam 364 . The second analog signal may be converted to a second digital signal by a second converter 420 . Processor 334 may include a second frequency data module 422 that may determine a second set of frequency data that corresponds to one or more of frequency components of the second digital signal. In some instances, the second digital signal may be averaged at a second averager module 424 . In such instances, the averaged second digital signal may then be transmitted to second frequency data module 422 . [0076] The first set of frequency data and the second set of frequency data may be received by a frequency data combination module 426 . Frequency data combination module 426 may linearly combine the first set of frequency data and the second set of frequency data, and may generate a range rate signal and a range signal derived from the mixed frequency data. [0077] FIG. 5 illustrates a processor 334 according to another embodiment of the invention. Processor 334 may include a first detector 510 and a second detector 512 that may receive first combined target beam 362 and second combined target beam 364 , respectively. First detector 510 and second detector 512 may generate a first analog signal and a second analog signal associated with first combined target beam 362 and second combined target beam 364 , respectively. Processor 334 may mix first combined target beam 362 and second combined target beam 364 electronically to generate the range signal and the range rate signal. For example, processor 334 may include a modulator 514 . Modulator 514 may multiply the first analog signal generated by first detector 510 and the second analog signal generated by second detector 512 to create a combined analog signal. In such embodiments, processor 334 may include a first filter 516 and a second filter 518 that receive the combined analog signal. First filter 516 may filter the combined analog signal to generate a first filtered signal. In some instances, first filter 516 may include a low-pass filter. The first filtered signal may be converted by a first converter 520 to generate the range rate signal. Second filter 518 may filter the combined analog signal to generate a second filtered signal. For instance, second filter 518 may include a high-pass filter. The second filtered signal may be converted by a second converter 522 to generate the range signal. [0078] FIG. 6 illustrates a processor 334 according to yet another embodiment of the invention. Processor 334 may mix first combined target beam 362 and second combined target beam 364 optically to generate the range signal and the range rate signal. For example, processor 334 may include a detector 610 that receives first combined target beam 362 and second combined target beam 364 and generates a combined analog signal based on the detection. In such embodiments, processor 334 may include a first filter 612 and a second filter 614 that receive the combined analog signal. First filter 612 may filter the combined analog signal to generate a first filtered signal. First filter 612 may include a low-pass filter. The first filtered signal may be converted by a first converter 616 to generate the range rate signal. Second filter 614 may filter the combined analog signal to generate a second filtered signal. Second filter 14 may include a high-pass filter. The second filtered signal may be converted by a second converter 618 to generate the range signal. [0079] Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

1a

CROSS-REFERENCE TO RELATED APPLICATION [0001] This non-provisional application claims priority to the pending provisional application 61/689,460 filed on Jun. 6, 2012 which is owned by the same inventor. BACKGROUND OF THE INVENTION [0002] The vehicle mounted feed hopper device generally relates to agricultural implements and more specifically to portable livestock feed delivery devices. More particularly, the invention mixes feed as its paddle mixers and dispensing screw turn oppositely. [0003] For millennia, people have raised livestock. People herded the livestock on range, often open, and the livestock ate what they could find. Though this description mentions livestock and cattle, livestock includes other animals reared for human consumption. People gathered livestock into herds of a size that fit the capacity of the owner. In some countries, large herds equated to immense wealth. Here, large herds spawned the cowboys of the Old West. The cowboys would gather the herds from Texas to Montana and move the herds towards the interior of the Great Plains, such as Kansas railheads for live transport to the East Coast or for packing activity elsewhere in the country. The cattle drives of the Old West became legend for their size and the consumption of forage by the cattle on the move. Large numbers of cattle in a herd often called for a large ranch. Select ranches, as in Texas, consisted of many square miles. Over time, disputes arose between settlers on the Great Plains and the cattlemen moving their herds across the ranges of the Great Plains. In time, governmental action settled the dispute and allowed settlers to remain, dooming free range of cattle. Cattle returned to ranches. With the onset of two World Wars, demand for beef continued its increases. [0004] Though no longer able to range freely, cattle proliferated on ranches. Once big in the days of cattle drives, ranches remain big and hold large herds of cattle on their many hundreds of acres or square miles. Ranching and cattle remain big business in the country. Though livestock have been with people for millennia, a key problem remains: livestock must eat and grow. Early on, cowboys moved cattle for foraging off the land. Keeping of cattle on ranches though limited foraging to defined land parcels. Weather and crop pests may further curtail foraging. However, cattlemen and ranchers supplement forage for livestock with feeds of all description. [0005] One feed includes blending grains with silage such as hay, that has a long stem, and delivering the blended feed to the livestock at feeding stations upon a ranch. The feeding stations include various bunkers or troughs that hold the feed at a height and position suitable for the animals to consume. The cattleman then restocks the bunkers or troughs as needed by the livestock or as desired by the cattleman for weight gain of the cattle. When a cattleman buys grain products directly from the suppliers instead of from the feed mill, the cattleman saves a significant amount of cost. Feed mills have a customary markup on their grains, as most distributors do for their costs, but they also charge a fee to mix grain products together before delivering them to your ranch or farm. Large cattle operations use Total Mixed Ration machines, or TMR, to cut out the middleman from their grain products. A ranching operation large enough to afford a TMR then purchases its commodities, i.e. corn, soy beans, and distillers grain, directly from the producers. A ranching operation then saves money in two respects: lower cost of mixing the commodities into a feed ration and the markup on the commodity from the feed mill. DESCRIPTION OF THE PRIOR ART [0006] Over the years, ranchers and implement makers have built and used various harvesting and feed processing machinery. The machinery accepts the agricultural product, typically plant based, mixes it, and then delivers it to the location desired by the rancher. The prior art includes two classes of feed handling machinery. The first class includes small, vehicle mounted, mobile animal feeding hopper, such as that shown by U.S. Pat. Nos. 5,653,567 to Taylor and 6,263,833 to Runyan. The second class has a larger mobile feed mixing machine called a Total Mixed Ration, or “TMR” machine such as that shown by U.S. Pat. Nos. 6,945,485 to Douglas, 4,896,970 and 4,799,800 to Schuler, 4,707,140 to Mohrlang, and 7,507,016 to Huberdeau. [0007] The small feed hoppers have a typical mount upon a flat bed ¾ or 1 ton pickup truck. They have open tops for addition of animal feed from a silo, a larger truck, or an implement. Normally, this feed has a pre-mixed set of grains, but can be an individual ingredient. The feeder then goes to the field or location via the pickup truck and at the field, where an electrically driven motor meters out the feed into feed bunks, or troughs, for the livestock. These feed hoppers also have counters that allow the operator to know how much feed remains in a hopper or has left the hopper into the feed bunk. The counters differ slightly from manufacturer to manufacturer. The prior art patents above describe the counting devises for each unit. The main two manufacturers of these types of units specialize and only build agricultural hoppers. [0008] The larger TMRs have two configurations: vertical screw and horizontal screw. Each of these configurations has multiple subtypes, but in each, the mixer takes in multiple different products and combines them into a homogenous mixture. TMRs have their name because of their ability to mix grains as well as roughage. Roughage, the main ingredient in most grazing animal's diets, generally comes in the form of hay and silage, that have long stems from their parent plants. TMRs have their typical mount upon large or medium duty, straight trucks or on trailers connected to large agricultural tractors. All TMRs receive product through an open top. The product is mixed and then metered through a gate in the side of the TMR for dispensing. Like the smaller feed hoppers, the TMR also meters product into feed bunks, but are not as mobile or versatile. [0009] A TMR requires a large capital investment: about $25,000 to over $100,000. Only large animal operations can afford this type of mixer. On the other hand, the smaller feed hopper has a capital investment of less than $4,000, but it only transports the feed and has no cost savings. [0010] The present invention overcomes the disadvantages of the prior art and provides a vehicle mounted feed hopper device that performs the same tasks as a larger feed hopper and mixes the feed as well. This invention provides small to medium sized livestock operations the same cost saving opportunity that the large operations have with the TMRs. The present invention accomplishes these goals of cost savings and accurate feed dispensing with mixers moving material opposite the conveyor. SUMMARY OF THE INVENTION [0011] Generally, the vehicle mounted feed hopper device has an enclosure upon a frame, the enclosure, or hopper, having a generally V shape, at least one paddle mixer journaled into the enclosure, a conveyor beneath the paddle mixer, an outlet proximate one end of the conveyor, an elongated flexible member operatively connected to the paddle mixer and the conveyor, and a hydraulic motor supplying driving force to the elongated flexible member through gearing. The present invention functions like the horizontal screw TMR, but at the scale of a small mobile feed hopper. The invention will accept multiple grain products through its open top and mix them like the TMR, except for roughage or silage products. Due to the capacity of this machine, it is impractical to include the roughage products into the mixer. The present invention dispenses its mixed feed through the outlet as it meters feed into feed bunks. [0012] There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood and that the present contribution to the art may be better appreciated. The present invention also includes paddles with multiple orientations, various fluting characteristics upon the conveyor, two mixers that turn in opposite directions, and reduction in eddy losses within the enclosure. Additional features of the invention will be described hereinafter and which will form the subject matter of the claims attached. [0013] Numerous objects, features and advantages of the present invention will be readily apparent to those of ordinary skill in the art upon a reading of the following detailed description of the presently preferred, but nonetheless illustrative, embodiment of the present invention when taken in conjunction with the accompanying drawings. Before explaining the current embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. [0014] One object of the present invention is to provide a vehicle mounted feed hopper device that mixes feed in a hopper mounted transverse upon a small truck. [0015] Another object is to provide such a vehicle mounted feed hopper device that mixes multiple feeds excluding roughage, that is, plant fibers with long stems. [0016] Another object is to provide such a vehicle mounted feed hopper that turns its conveyor and paddles in opposite directions. [0017] Another object is to provide such a vehicle mounted feed hopper that can be readily installed and operated by hands, foremen, drivers, operators, and similar semi-skilled labor. [0018] Another object is to provide such a vehicle mounted feed hopper that can be readily cleaned and repaired by hands, foremen, drivers, operators, and similar semi-skilled labor. [0019] Another object is to provide such a vehicle mounted feed hopper that can be readily overhauled by implement mechanics. [0020] Another object is to provide such a vehicle mounted feed hopper that can be easily and efficiently manufactured and marketed to the consuming ranchers, farmers, and livestock operations. [0021] These together with other objects of the invention, along with the various features of novelty that characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated a preferred embodiment of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0022] In referring to the drawings, [0023] FIG. 1 provides a perspective view of the invention; [0024] FIG. 2 shows an end view of the invention; [0025] FIG. 3 shows a side view of the invention; [0026] FIG. 4 provides an end view of the invention opposite that of FIG. 2 ; [0027] FIG. 5 describes a top view of the invention; [0028] FIG. 6 illustrates a perspective view of the invention with the top removed and chute in the foreground; [0029] FIG. 7 provides a perspective view of the invention with the top removed and gearing in the foreground; [0030] FIG. 8 describes an end view of the invention including gearing; [0031] FIG. 8 a shows an end view of an alternate embodiment of the invention including gearing; [0032] FIG. 8 b shows an end view of the alternate embodiment with the drive gear removed; [0033] FIG. 9 shows a side view of the invention with covers removed from FIG. 3 ; and, [0034] FIG. 10 describes a top view of the invention with the lid and top panel removed from FIG. 5 . [0035] The same reference numerals refer to the same parts throughout the various figures. DESCRIPTION OF THE PREFERRED EMBODIMENT [0036] The present art overcomes the prior art limitations by providing a vehicle mounted feed hopper device. A prior art TMR holds between 140 to 1600 cubic foot of material and the present invention 1 will hold 10 to 100 cubic foot of material as shown in FIG. 1 , within the class of mobile feed hoppers in the 10 to 100 cubic foot range. The present invention has a generally rectangular base 2 formed of angle iron defining a plane with two longitudinal side members 2 a and two lateral end members 2 b . The longitudinal side members are mutually parallel and spaced apart and the lateral end members are mutually parallel and spaced apart and perpendicular to the side members. At the intersection of an end member with a side member, the base has a leg 3 extending perpendicular to the end member, the side member, and the plane of the base. The base has an orientation to fit the invention transverse upon a transport vehicle, such as a light duty flat bed truck, thus the lateral end parallels the length of the truck. [0037] Upon the base, the invention present invention has a metal enclosure 4 with a top panel 5 and a V shaped bottom 6 spaced apart and beneath the top panel. The top panel has a generally rectangular, planar shape, exceeding the dimensions of the base. Within the top panel, an aperture (not shown) receives material placed within the invention from an external source. The aperture has a lid 7 upon it as shown in FIG. 1 . The lid is also generally rectangular with a size exceeding the aperture but much less than the dimensions of the top panel. The lid includes a handle upon it for manual opening. Opening of the lid occurs upon sliding it along a track, here shown as two mutually parallel and spaced apart rails 8 that extend outwardly from the aperture partially along the length of the top panel. Similar to the base, the top panel has two longitudinal edges and two lateral edges. The longitudinal edges are mutually parallel and spaced apart and the lateral edges are mutually parallel and spaced apart and perpendicular to the longitudinal edges. Upon one lateral edge proximate the rails 8 , as at 5 a , a back panel 9 depends perpendicular to and beneath the top panel 5 . The back panel is generally planar but of a pentagonal shape that comports with the V shaped bottom 6 . Extending from the back panel, the present invention has two spaced apart bearings 10 and an outlet 11 proximate the vertex the V shaped bottom 6 . The outlet is generally round and hollow. The Applicant also foresees the lid 7 having a width nearly that of the hopper itself, while still sliding upon rails. In an alternate embodiment, the hopper has the lid removed so that it remains open entirely during its usage. The hopper without a lid may have a hollow frame resting upon the hopper that stiffens the side panels, back panel, and front panel as it provides a warning to persons approaching the hopper. [0038] Opposite the back panel 9 and depending from the top panel 5 upon the other lateral edge 5 b , a drive cover 12 extends beneath the top panel 5 and outwardly from the remainder of the enclosure. The drive cover extends generally opposite the chute as shown. The drive cover extends across the width of the top panel and descends to follow the V shaped bottom 6 . Appurtenant to the drive cover, a motor cover 13 extends beneath the drive cover and along a portion of one half of the V shaped bottom. The motor cover conceals and shelters a hydraulic motor 14 secured to one leg, as at 3 a. [0039] Spanning between the back panel 9 , the drive cover 12 , and the top panel 5 , the enclosure 4 has a side panel shown, here the left side panel 15 . The left side panel depends from one longitudinal edge 5 c of the top panel for the length of the top panel and generally more than the length of the longitudinal side members 2 a . The left side panel depends for a height that accommodates the desired volume, or capacity of the invention, generally the height exceeds that of the legs 3 . The height of the left side panel accommodates the internal mechanism for material handling, here shown as its bearings 10 in the back panel 9 . [0040] Turning the invention towards the back panel 9 , FIG. 2 shows an end view typically seen during unloading of material. The enclosure 4 of the invention 1 has its lid 7 centered upon the top panel 5 . From a lateral edge 5 a , the back panel 9 depends perpendicular and beneath the top panel. The back panel has a pentagonal shape with one edge parallel to the lateral edge 5 a , two mutually parallel and spaced apart side edges that join to the left side panel 15 and its counterpart right side panel as later shown in FIG. 6 , and two other edges that attain a partially flattened V shape, as shown in this figure. The edges of the V shape have a rounded junction, centered upon the back panel and at the lowest portion of the back panel. Upon the back panel between the side edges, the bearings 10 of the internal mechanism extend. The bearings have a position generally in line with the rails 8 of the top panel 5 . Proximate the junction of the edges of the V shape, the back panel has its outlet 11 that discharges the material from the hopper of the invention. The chute has its hollow round shape as before. Within the chute though, it has an outlet bearing 16 that supports a journal end of an internal mechanism later shown. The outlet bearing has a generally V shaped form with two attachments to the outlet generally towards the bearings 10 . Inward from the back panel, the bottom 6 joined to the two edges of the V shape of the back panel accepts the legs 3 of the base 2 , here shown as two legs. In the background, one leg, as at 3 a in FIG. 1 , receives the hydraulic motor 14 proximate the motor cover, that is opposite from the back panel. The legs 3 connect to the base at the lateral member 2 b and have a height so that the outlet is slightly above the lateral member. [0041] Rotating the invention once more, FIG. 3 shows a side view of the invention 1 generally along its length. The invention has its enclosure 4 connecting to the base 2 upon legs 3 as previously described. The enclosure 4 has its top panel 5 , here shown on its longitudinal edge 5 c , with the back panel 9 towards the right of the figure and mutually spaced apart from the drive cover 12 towards the left of the figure. The back panel has the bearings 10 of the internal mechanism extending outwardly from it and the outlet 11 also extending outwardly from the back panel and slightly above the lateral member 2 b of the base 2 . The drive cover 12 extends outwardly from the enclosure, that is, beyond the length of the top panel and extends downwardly, that is, towards the plane of the base 2 . Beneath the drive cover, the enclosure has the motor cover 13 of shorter height and width than the drive cover, as later shown in FIG. 4 . The motor cover shelters and conceals the motor 14 as previously described. Between the motor cover, the legs, and the back panel, the enclosure has the left side panel 15 and a portion of the V shaped bottom, here at 6 a . The left side panel has a generally elongated rectangular shape of similar length to the top panel, particularly the longitudinal edge 5 c . The portion of the V shaped bottom also has a generally elongated rectangular shape of similar length as the left side panel but at an inwardly sloping angle from the left side panel. The inwardly sloping angle defines on half of the V shaped bottom. [0042] Having mentioned the drive cover previously, FIG. 4 shows an end view of the invention with the drive cover 12 in the foreground. The drive cover also has a pentagonal shape similar to that of the back panel. However, the drive cover has its pentagonal shape truncated proximate the intersection of the edges of the V shape by the motor cover 13 . The motor cover has a generally rectangular shape fitted upon the intersection of the edges of the V shape defining the bottom of the drive cover and with one corner of the motor cover itself truncated to follow the V shape of the bottom as shown. The motor cover rests upon a lateral member 2 b of the base and in front of leg 3 a , not shown, that supports the motor. Above the drive cover, the enclosure has the top panel 5 with its lid 7 as previously described. [0043] After viewing the invention from two ends and a side, FIG. 5 shows the invention from above. The invention 1 has its enclosure 4 with the top panel 5 that has a lid 7 upon rails 8 towards one end. Proximate that end, the invention has the back panel 9 , here to the right, with the two spaced apart bearings 10 centered about and above the outlet 11 . Opposite the back panel, the enclosure has the drive cover 12 connecting to the top panel and the motor cover 13 slightly beneath the drive cover. [0044] Upon removing the top panel 5 , the drive cover 12 , and the motor cover 13 , FIG. 6 shows the invention with its enclosure 4 and internal mechanism within the enclosure and the back panel 9 in the foreground. The enclosure rests upon the legs 3 of the base 2 as described above. The enclosure also has its back panel 9 , left side panel 15 , and bottom portion 6 a as previously described. The enclosure also has its right side panel 16 of similar dimensions to the left side panel and mutually parallel and spaced apart from the left side panel. Spanning between the left side panel and the right side panel opposite the back panel 9 , the enclosure has its front panel 17 . The front panel has a similar pentagonal shape as the back panel. From the bearings 10 inwardly, the invention has a left mixer 17 having a plurality of paddles thereon, generally to the left of the chute 11 and extending to the front panel 17 , and a right mixer 18 having a plurality of paddles at a different orientation that the paddles of the left mixer, generally to the right of the chute 11 and extending to the front panel 17 . The left mixer and the right mixer are generally shafts with T shaped paddles extending perpendicular to the shafts. The left mixer and the right mixer counter rotate to assist in moving material or feed through the hopper. [0045] Similar to FIG. 6 , FIG. 7 here shows the invention with its enclosure 4 and internal mechanism inside it but the front panel 17 in the foreground. The enclosure rests upon the legs 3 of the base 2 as described above. The enclosure also has its back panel 9 , left side panel 15 , and bottom portion 6 a as previously described. The enclosure also has its right side panel 16 of similar dimensions to the left side panel and mutually parallel and spaced apart from the left side panel. Spanning between the left side panel and the right side panel opposite the back panel 9 , the enclosure has its front panel 17 . The front panel has a similar pentagonal shape as the back panel. From the bearings inwardly as previously shown, the invention has the left mixer 18 with fewer paddles shown in this figure and extending to the front panel 18 , and the right mixer 19 having a plurality of paddles, generally to the right of the chute 11 and extending to the front panel 17 . The shafts of the left mixer and the right mixer each connect to a sprocket, as at 20 , 21 respectively outwardly of the front panel. The sprockets rotate by action of a chain 22 , or other flexible elongated member, such as a belt, so that the sprockets rotate in opposite directions. The chain also turns a gear 23 connected to a screw conveyor, not shown. The screw gear also operatively receives a drive chain 24 , or other flexible elongated member, and the drive chain operatively connects to the drive sprocket 25 of the motor 14 . The hydraulic motor provides at least four horsepower suitable for simultaneously driving two mixers and the screw conveyor with material thereon. The hydraulic motor operates from the host vehicle hydraulic system. Alternatively, the motor operates upon reduction gearing and shafts from the drive train of the host vehicle. From testing, the applicant has identified that electrical motors in this application would draw current in excess of the capacity of the typical host vehicle, or truck. Alternatively, a gearbox drive, not shown, supplies direct mechanical power transfer from the host vehicle drive train to the conveyor and the paddles. The direct power transfer occurs through a gear box and related shaft or alternatively through load cells. Upwardly from the two sprockets, the front panel also has a shelf 17 a that extends across the width of the panel and slightly outwardly from the panel, such as for the width of the chain. [0046] FIG. 8 shows the driving mechanism of the invention more closely. As above, the left mixer connects to its sprocket 20 and the right mixer to its sprocket 21 outwardly of the front panel. The two sprockets have the largest diameter and largest tooth count of the components in the driving mechanism. The sprockets rotate by the action of the chain 22 , belt, or other flexible elongated member, in opposite directions. The opposite rotation occurs as the chain 22 passes upon a first idler pulley 26 upon the front panel slightly beneath the shelf 17 a , above the left sprocket 20 and inwardly from the center of the left sprocket. Also keeping tension in the chain or other flexible elongated member, a second idler pulley 27 has its position upon the front panel beneath the left sprocket 20 , outwardly from the center of the left sprocket, and outwardly from the first sprocket. The two idler pulleys have sufficient biasing strength, maintaining the chain 22 taut during initial mixing of material, the time of maximum load, and later during continuous mixing, a time of lesser load upon the driving mechanism. The chain continues around the second idler pulley and turns the gear 23 connected to a screw conveyor. Outwardly from the screw gear, the screw shaft also has a drive gear 23 a with a larger diameter than the screw gear and a higher tooth count. This drive gear 23 a receives the drive chain 24 that delivers the power from the motor's drive sprocket 25 . The hydraulic motor secures to the leg 3 a and the left bottom 6 a as shown. The enclosure rests upon the other legs 3 and the base 2 . [0047] FIG. 8 a provides an alternate embodiment of the driving mechanism where the left mixer connects to its sprocket 20 and the right mixer to its sprocket 21 outwardly of the front panel 17 . The two sprockets have the largest diameter as shown. The sprockets rotate by the action of the chain 22 or other flexible elongated member, in opposite directions. The opposite rotation occurs as the chain 22 passes upon a first idler pulley 26 located upon the front panel between two shelves 17 a towards the left side panel 16 , above the left sprocket 20 and inwardly from the center of the left sprocket. Also keeping tension in the chain or other flexible elongated member, a second idler pulley 27 has its position upon the front panel beneath the left sprocket 20 , inwardly from the center of the left sprocket and the first sprocket. The chain continues to a third idler pulley 27 a partially shown in this figure behind drive gear 23 of the conveyor. The three idler pulleys have sufficient biasing strength, maintaining the chain 22 taut during initial mixing of material, the time of maximum load, and later during continuous mixing, a time of lesser load upon the driving mechanism. The chain continues around the third idler pulley and turns a gear sprocket 23 a connected to the screw conveyor but concealed behind the drive gear 23 . The chain then travels from the gear sprocket to the sprocket 21 for the right mixer. Outwardly from the gear sprocket 23 a , the screw shaft also has the drive gear 23 with a larger diameter than the gear sprocket and a higher tooth count. This drive gear 23 receives the drive chain 24 that delivers the power from the motor's drive sprocket 25 as shown before. [0048] FIG. 8 b shows the gearing and chain proximate the front panel 17 with the drive gear 23 and drive chain 24 removed. As above, the chain 22 begins its travels upon the first idler pulley 26 and proceeds above the left sprocket 20 and inwardly from the center of the left sprocket. The chain proceeds around the inner teeth of the left sprocket towards the second idler pulley 27 which is beneath the left sprocket and inwardly from the center of the left sprocket and the first sprocket. The chain continues to a third idler pulley 27 a spaced inwardly from the second idler pulley upon an idler arm 27 b . The third idler pulley is located upon the free end of the idler arm 27 b while the second idler pulley is upon the pivoting end of the idler arm. The idler arm's pivoting end and the second idler puller are generally proximate the gear sprocket 23 a . The pivoting end of the idler arm secures to a post 17 b upon the front panel. The post is generally perpendicular to the shelves 17 a and upon the exterior of the front panel as shown. The chain continues around the third idler pulley and turns the gear sprocket 23 a so that the screw conveyor turns. The chain then travels from the gear sprocket to the sprocket 21 for the right mixer and back to the first idler pulley. The three idler pulleys in cooperation with the idler arm provide sufficient biasing to keep the chain 22 taut during initial mixing of material, maximum load of material, and during lesser load upon the driving mechanism. [0049] Turning the invention again, FIG. 9 shows the invention from a side view with the top panel, drive cover, and motor cover removed. This figure has a similar appearance to FIG. 3 but here showing the drive mechanism from the side. [0050] As mentioned above, the driving mechanism turns three components simultaneously to mix product in a hopper, enclosure of this volume. FIG. 10 shows the three components and the remainder of the invention from above. The driving mechanism supplies power from the motor 14 through the screw gear 23 to a screw conveyor 28 , then the right sprocket 21 to the right mixer 19 , and then the left sprocket 20 to the left mixer 18 . The screw conveyor 28 has its position within the bottom 6 of the enclosure 4 , generally centered, and a distance above the junction of the two edges of the V shape described above. The screw conveyor includes helical flights at a regular interval and arranged to advance material axially, along the screw conveyor. The flighting, as at 28 a , has a construction of a coiled bar of metal wrapped around a shaft 28 b . During usage, an operator directs the screw conveyor in clockwise rotation to mix the material and move it away from the dispensing outlet, that is, towards the front panel. Then for dispensing of material, the operator reverses the direction of the screw conveyor, that is, counterclockwise, which moves the material toward the outlet 11 , dispensing it into a feed bunk. The helical flights have an outer diameter that fits within the bottom panels as at 6 . [0051] For this volume of hopper, the invention has at least one paddle mixer above the screw conveyor. Though FIG. 10 shows two paddle mixers, the Applicant foresees that the invention may operate upon a single paddle mixer in an alternate embodiment. Meanwhile, the two paddle mixers, 18 , 19 always move the feed in the opposite direction from the screw conveyor, producing two dimensions of mixing. The paddle mixers mix the material where one, 18 , turns clockwise while the other, 19 turns counterclockwise, the paddle mixers counter rotate. Each paddle mixer has a plurality of paddles arranged thereon. Each paddle, as at 29 has a generally T shape with a wide, rectangular plate 29 a parallel to a plane including the length of the mixer shaft, and a thin rounded stem 29 b generally perpendicular to the mixer shaft. Each paddle mixer may have paddles 29 in select arrangements. Here, the right mixer 19 has paddles in a primary arrangement 30 and a secondary arrangement 31 . The primary arrangement has paired paddles in opposition with the plates 29 a generally at an angle to the shaft, particularly towards its length or longitudinal axis. The angle of the paddles, particularly the plates, is from about 15° to about 75°. The secondary arrangement has paired paddles in opposition but with the plates pitched at the mirror image to the plates of the primary arrangement, that is, from about 75° to about 15° to the shaft, particularly towards its length or longitudinal axis and opposite that of the plate on the other side, forming an X shaped pattern as shown. Here, the right mixer has three primary arrangements between four secondary arrangements of its paddles in an alternating manner which produces an axial movement of the feed, often grain. Opposite the right mixer, the left mixer 18 has seven secondary arrangements of its paddles. In another embodiment, the invention has produced optimal flow of feed utilizing paddles at a 45° angle to the shaft. [0052] Therefore, while in mixing mode of the invention, the left mixer and the right mixer, through their paddles, drive the material or feed, longitudinally, toward the dispensing outlet, that is, the back panel 9 of the hopper and the screw conveyor drives it away from the dispensing outlet towards the front panel 17 . When the feed reaches the front panel 17 , the conveyor discharges the feed against the bottom 6 and its portions 6 a , 6 b with their approximately 45° upward angle, shown in FIGS. 2 , 3 , 8 . The paddle mixers counter rotate and in mixing mode raise feed in the center of the hopper and lower feed on the outside of the hopper. The feed then travels upwardly on the bottom portions until the paddle mixers, 18 , 19 collect the feed and move it towards the back panel. Upon engaging the back panel, the feed drops into a void created by the screw conveyor and the mixing cycle repeats. [0053] While in the mode of dispensing feed from the invention, the left mixer and the right mixer, through their paddles, continue mixing, but they drive the material away from the back panel towards the front panel. The screw conveyor, though below the paddles, therefore conveys the feed in the opposite direction, that is, toward the back panel, and out the dispensing outlet. The paddle mixers and the screw conveyor rotate in the opposite direction as in the mixing mode. [0054] In an alternate embodiment, the present invention includes switches and wiring from the device to a remote location, such as the cab of a host vehicle or truck. The switches are foreseen to control rotation and direction of the mixers and the conveyor either jointly or singly. [0055] The screw conveyor and the left mixer and the right mixer turn using a hydraulic motor 14 coupled by a chain dive 24 , 22 . The prior art hoppers typically utilize DC electric gear motors. The present invention uses hydraulic actuated motors to meet the greater horsepower requirements of the mixing action. Few hoppers in the prior art use a paddle style mixing screw as in the present invention. And fewer prior art hoppers, if any, drive their conveyors and paddles in one direction to mix and the opposite direction to dispense as in the present invention. [0056] From the aforementioned description, a vehicle mounted feed hopper device has been described. The vehicle mounted feed hopper device is uniquely capable of mixing feed materials, excluding silage, in a hopper less than 101 cubic feet while attaining blends suitable and nutritious for livestock. The vehicle mounted feed hopper device and its various components may be manufactured from many materials, including but not limited to, wood, steel, aluminum, polymers, polypropylene, polyvinyl chloride, high density polyethylene, polypropylene, ferrous and non-ferrous metals, their alloys, and composites. [0057] Various aspects of the illustrative embodiments have been described using terms commonly employed by those skilled in the art to convey the substance of their work to others skilled in the art. However, it will be apparent to those skilled in the art that the present invention may be practiced with only some of the described aspects. For purposes of explanation, specific numbers, materials and configurations have been set forth in order to provide a thorough understanding of the illustrative embodiments. However, it will be apparent to one skilled in the art that the present invention may be practiced without the specific details. In other instances, well known features are omitted or simplified in order not to obscure the illustrative embodiments. [0058] Various operations have been described as multiple discrete operations, in a manner that is most helpful in understanding the present invention, however, the order of description should not be construed as to imply that these operations are necessarily order dependent. In particular, these operations need not be performed in the order of presentation. [0059] Moreover, in the specification and the following claims, the terms “first,” “second,” “third” and the like—when they appear—are used merely as labels, and are not intended to impose numerical requirements on their objects. [0060] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to ascertain the nature of the technical disclosure. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. [0061] 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. Therefore, the claims include such equivalent constructions insofar as they do not depart from the spirit and the scope of the present invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] (Not Applicable) STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT [0002] (Not Applicable) BACKGROUND OF THE INVENTION [0003] The present invention relates generally to baby wipes warmers, and more particularly to an improved baby wipes warmer having a liquid tank located therewithin which provides heated liquid vapors to the baby wipes for maintaining moisture and coloration of the baby wipes. [0004] Baby wipes have been marketed in the United States for many years. Essentially, baby wipes are small pre-moistened paper or synthetic (non-woven) towelettes and are typically available in packages to the consuming public. They are primarily used to cleanse the skin of infants and small children. The wipe-fluid content for these pre-moistened wipes is generally comprised of cleansers, lotions and preservatives. [0005] A few years after the baby wipes were introduced into the marketplace, various products for warming the wipes were made available to the public. Such products have been devised to comfort the baby wipe users from the inherent “chill” given off by the contact of the moistened wipes. For example, it is now a common practice for parents to employ the use of warm baby wipes on their children. [0006] These warming products are generally electric operated and come in two distinct styles. One is an “electric blanket” style which is sized to wrap around the external surfaces of a plastic baby wipes container. The other is a self-contained plastic “appliance” style which warms the accommodated baby wipes with its internally positioned heating element. Though such currently known and available baby wipes warming products achieve their primary objective of warming baby wipes, they possess certain deficiencies which detract from their overall utility. [0007] Perhaps the two greatest deficiencies of the prior art baby wipes warming products are the inabilities to sustain the moisture content and coloration of the baby wipes. More specifically, drying of the baby wipes occurs due to heating of their moisture which accelerates dehydration. Further, discoloration of the same appears to be inevitable because of a reaction of various chemicals in the wipes to heating. As such, even though these existing products may adequately warm the baby wipes, they cannot, however, seem to avoid the undesirable effects of dehydration and discoloration when warming them. [0008] Thus, there exists a substantial need in the industry, and in the infant products manufacturing business in particular, for a baby wipes warming product that can effectively provide warmth to the baby wipes without dehydrating and/or discoloring them. Further, there exists a need for a baby wipes warming product which can achieve these objectives in a user-friendly and time-efficient manner. BRIEF SUMMARY OF THE INVENTION [0009] The present invention specifically addresses and overcomes the above-described deficiencies of prior art baby wipes warming products by providing an improved baby wipes warmer that can warm baby wipes while substantially maintaining their original moisture content and coloration. Briefly, in order to accomplish such objectives, the present baby wipes warmer may utilize a heatable liquid tank assembly which can provide liquid vapors to the baby wipes through its at least one vapor aperture. Alternatively, the present baby wipes warmer may use an elevated support surface such as a suspension tray in lieu of the tank assembly in which the baby wipes supported thereon can be heated while sustaining their moisture and color through vapors rising from the heated liquid pool disposed thereunderneath. These as well as other features of the present invention will be discussed in more detail infra. [0010] In accordance with a first preferred embodiment of the present invention, there is provided a baby wipes warmer for warming baby wipes while substantially maintaining their original moisture content and coloration. Such warmer comprises a housing with a pivotally engaged lid member that can open and close relative thereto. A liquid tank assembly is disposed within the housing in such a way that its upper tank surface is vertically surrounded by the housing's interior-side housing wall and horizontally closed off by the lid member. In this respect, an inside compartment is defined which can be selectively accessed by opening and closing the lid member. [0011] The liquid tank assembly is preferably fabricated from any heat conducting material such as metal (e.g., aluminum). The tank assembly comprises a liquid compartment which is formed between its upper and lower tank surfaces. The liquid compartment is used to hold any liquid that can produce vapors when heated such as water. By heating the liquid compartment, a portion of the liquid may change its physical state and flow into the inside compartment as vapors which helps to maintain the original moisture content and coloration of the baby wipes placed thereat. To allow the rising vapors to seep into the inside compartment from the liquid compartment, at least one vapor aperture is formed through the upper tank surface. [0012] A heating element is disposed within the housing relative to the lower tank surface for the purpose of heating the liquid. The heating element may be located in various positions to achieve such purpose. For example, the heating element can be placed within the liquid compartment itself adjacent the lower tank surface to substantially extend thereabout. However, the heating element can also be placed outside the liquid compartment and still provide the requisite heat to the lower tank surface by being adjacent thereto. It is specifically contemplated herein that any types of heating element such as an electrically powered heating pad may be used. [0013] In the first preferred embodiment, the upper tank surface is characterized by a generally flat support surface used for supporting the baby wipes thereon. This surface may be defined to be a part of the upper tank surface itself. In the alternative, however, the support surface can be formed by a suspension tray which is removably engaged upon a sponge material that extends through an exposed opening defined on the upper tank surface. If the latter configuration is used, the vapor aperture(s) of the upper tank surface is formed by the sponge itself as its inherent characteristics would allow the vapors to gradually flow therethrough. Moreover, a ridge may be formed around both types of support surfaces for confining the baby wipes within the physical boundary set thereby. [0014] Further in the first preferred embodiment of the present invention, there may be provided a liquid reservoir which is set in fluid communication with the liquid compartment. The liquid reservoir may be disposed within the housing adjacent the liquid tank assembly, or alternatively mounted to an exterior of the housing. To establish fluid communication, any elongated and hollowed structure such as a conduit may be used to provide a flow channel between the reservoir and the liquid compartment. As will be demonstrated below, the liquid reservoir ensures that the liquid within the liquid compartment is always sustained at a certain level sufficient to provide adequate evaporation. [0015] In accordance with a second preferred embodiment of the present invention, there is provided a baby wipes warmer which utilizes an elevated support surface such as a suspension tray in lieu of the tank assembly. The support surface is disposed within an inside compartment which is collectively formed by the interior-side housing wall and the upper housing wall. More specifically, the interior-side housing wall defines a generally flattened interior compartment surface used for placing the support surface thereon above the liquid level contained within the inside compartment. By doing so, the baby wipes accommodated thereon can be heated while sustaining their moisture and color through vapors rising from the heated liquid pool disposed underneath. [0016] In accordance with a third preferred embodiment of the present invention, a liquid tank assembly in the form of an elongated central channel is embedded laterally along the flattened interior compartment surface. This assembly forming the elongated central channel includes a sponge material therewithin so that it may draw liquid out of the reservoir by capillarity. Similar to the first embodied baby wipes warmer, its upper tank surface comprises at least one vapor aperture which allows liquid vapor to travel therethrough. [0017] In illustrating the operation for all embodied baby wipes warmers, a stack of baby wipes may be placed within the inside compartment simply by opening and then closing the lid member. The liquid contained within the baby wipes warmer should be checked to ensure that there is sufficient quantity, i.e., water level present. This can be accomplished by checking the liquid reservoir (for the first and third embodiments) or the liquid level within the inside compartment itself (for the second embodiment). Thereafter, the baby wipes warmer may be plugged into an electrical outlet in order to activate the heating element (if not already done). By following this easy-to-follow procedure, portions of the liquid can transition into vapors when sufficiently heated which then travel upwardly through the vapor aperture(s) to contact the baby wipes so that they may be maintained in constant moisturized condition and coloration. BRIEF DESCRIPTION OF THE DRAWINGS [0018] These as well as other features of the present invention will become more apparent upon reference to the drawings wherein: [0019] [0019]FIG. 1 is a perspective view of a baby wipes warmer constructed in accordance with a first preferred embodiment of the present invention and illustrating a stack of baby wipes positioned within its inside compartment; [0020] [0020]FIG. 2 is an exploded perspective view of the baby wipes warmer of FIG. 1 and illustrating a liquid reservoir which is exteriorly mountable to its exterior-side housing wall; [0021] [0021]FIG. 3 is a cross-sectional view of the baby wipes warmer of FIG. 1 and illustrating a heating element disposed between its water tank assembly and base member; [0022] [0022]FIG. 3A is a plan view of the water tank assembly of FIG. 3 and illustrating a plurality of vapor apertures which are formed through its upper tank surface; [0023] [0023]FIG. 4 is a cross-sectional view of the baby wipes warmer of FIG. 1 and illustrating a heating element immersed in a quantity of liquid contained within its water tank assembly; [0024] [0024]FIG. 5 is a cross-sectional view of the baby wipes warmer of FIG. 1 and illustrating a suspension tray which is placed upon a sponge extending through an exposed opening of its water tank assembly; [0025] [0025]FIG. 6 is a cross-sectional view of a baby wipes warmer constructed in accordance with a 'second preferred embodiment of the present invention and illustrating a suspension tray which is placed directly over a quantity of liquid contained within its inside compartment; and [0026] [0026]FIG. 7 is a cross-sectional view of a baby wipes warmer constructed in accordance with a third preferred embodiment of the present invention and illustrating a sponge disposed within its water tank assembly which is in the form of a laterally extending central water channel. DETAILED DESCRIPTION OF THE INVENTION [0027] Referring now to the drawings wherein the showings are for purposes of illustrating preferred embodiments of the present invention only, and not for purposes of limiting the same, FIG. 1 prospectively illustrates a baby wipes warmer 10 constructed in accordance with a first preferred embodiment of the present invention. As indicated above, the baby wipes warmer 10 is adapted to warm a stack of baby wipes 12 accommodated therein while maintaining the wipes 12 in a substantially moisturized condition and with their original coloration (i.e., white). Those of ordinary skill in the art will recognize that the baby wipes warmer 10 may be formed to have a variety of external housing shapes, configurations, geometries, sizes and textures other than for that shown in the provided figures. [0028] Referring more particularly to FIGS. 1 and 2, the baby wipes warmer 10 comprises a housing 14 . This housing 14 may be fabricated from any rigid material, but plastic polymer is preferred. The housing 14 is formed having a main body member 16 and a base member 18 . More particularly, the body member 16 is peripherally defined by an exterior-side housing wall 20 with a base end 22 that engages onto the base member 18 . The base member 18 is contemplated to be used for supporting the baby wipes warmer 10 on any provided surface (e.g., desktop, floor, night stand, etc.) and may optionally include a plurality of adjustable foot pads 24 for this purpose. [0029] The housing 14 of the present baby wipes warmer 10 comprises a pivotally engaged top lid member 26 which is capable of opening and closing relative to the housing 14 . The lid member 26 may open and close utilizing any conventional methods such as using a door spring 28 , for example. When such lid member 26 is closed with respect to the housing 14 , it becomes an upper housing wall as it encloses the interior of the housing 14 from the outside. On the other hand, the opening of the lid member 26 allows access to an inside compartment 30 of the housing which will be discussed in more detail below. By accessing the inside compartment 30 , a stack of baby wipes 12 (layered or inter-folded stack) may be inserted and individually withdrawn for use. [0030] Referring now to FIGS. 2 and 3, a liquid tank assembly 32 is provided within the housing 14 . More specifically, the liquid tank assembly 32 is located between the body and base members 16 , 18 when they are engaged to each other in the manner described above. Upon such placement, the upper tank surface 34 of the tank assembly 32 collectively forms the inside compartment 30 with the interior-side housing wall 36 and the lid member 26 of the housing 14 . To describe this aspect in more detail, the upper tank surface 34 becomes vertically surrounded as the tank end 38 of the interior-side housing wall 36 is rested against the upper tank peripheral edge 40 thereof. The upper tank surface 34 is then horizontally closed off by the top lid member 26 forming the closed position. By such structural interaction, the requisite inside compartment 30 may be formed. [0031] Although FIG. 2 illustrates the liquid tank assembly 32 to be generally rectangular in configuration, it is expressly stated herein that the tank assembly 32 may be configured in other ways without deviating from its operational capabilities. [0032] The liquid tank assembly 32 defines a lower tank surface 42 which is positioned beneath the upper tank surface 34 towards the base member 18 . The upper and lower tank surfaces 34 , 42 are connected to each other by a surrounding side tank surface 44 to thereby form a liquid compartment 46 within the tank assembly 32 . This liquid compartment 46 is used for holding any liquid 48 that can evaporate when sufficiently heated and thus produce vapors 49 which are able to moisturize. A type of liquid 48 which is exemplary of this nature is water. However, the use of any fluids which may safely moisturize the baby wipes 12 are foreseeable. [0033] Because the contained liquid 48 must evaporate upon sufficient heating, the liquid tank assembly 32 should therefore be made from any material that is capable of rising in temperature in reaction to heating. It is preferred that the tank assembly 32 is fabricated from a heat-conducting material such as metal. More preferably, aluminum would be desirable for fabricating the tank assembly 32 as it reacts very well to heating. [0034] As shown in FIGS. 3 and 3A, the upper tank surface 34 includes a plurality of vapor apertures. 50 extending therethrough which provide fluid communication between the inside and liquid compartments 30 , 46 . The vapor apertures 50 allow the vapors 49 to pass through from the liquid compartment 46 to the inside compartment 30 so as to heat the wipes and maintain the baby wipes 12 in a constant moisturized condition and coloration. Preferably, the vapor apertures 50 are formed within the support surface 52 which is surrounded by a ridge 54 formed therearound. The support surface 52 is primarily used for accommodating the baby wipes 12 in which the surrounding ridge 54 confines them in place to prevent side-to-side movement. [0035] Referring now to FIG. 5 only, an alternative embodiment of the support surface 52 is depicted. In this embodiment, the upper tank surface 34 may instead define an exposed opening 56 between the ridge 54 . A support surface 52 may be disposed within this opening 56 in a manner as to extend substantially thereabout. Any structure providing a horizontal flat surface can be defined as the support surface 52 such as a suspension tray, for example. Preferably, a sponge material 58 extending through the exposed opening 56 from the liquid compartment 46 is used to removably secure the support surface 52 in place. The sponge 58 is preferred for this purpose as its naturally formed pores may simulate the vapor apertures 50 thereby permitting the vapors 49 to seep therethrough. [0036] Referring now to FIGS. 3 - 5 , a heating element 60 is provided within the housing 14 relative to the lower tank surface 42 . As noted above, the purpose of the heating element 60 is to heat the tank assembly 32 so that portions of liquid 48 are changed into vapors 49 . The heating element 60 may be disposed in various positions to achieve this purpose. One position is to locate the heating element 60 within the liquid compartment 46 so that it is immersed in liquid 48 to substantially extend adjacent the lower tank surface 42 (best shown in FIG. 4). The heating element 60 may also be positioned outside the liquid compartment 48 to extend adjacent the lower tank surface 42 (best shown in FIGS. 3 and 5). Although the use of various heaters is contemplated, it is preferred that an electrically powered heating pad is utilized. [0037] Referring now back to FIGS. 1 and 2, a liquid reservoir 62 may optionally be incorporated into the present baby wipes warmer 10 . However, the use of the liquid reservoir 62 is not mandatory as the liquid level within the liquid compartment 46 may be manually refilled. The liquid reservoir 62 is in fluid communication with the liquid compartment 46 . By such communication, the reservoir 62 can provide additional liquid to the liquid compartment 46 when needed. The additional liquid may be provided manually by operation of a valve device which may open and close the liquid flow into the liquid compartment 46 . The liquid reservoir 62 includes a refill cap 64 preferably fabricated from a rubber material for selectively accessing its interior. [0038] Similar to the heating element 60 , the liquid reservoir 62 may also be located in multiple positions. For example, it can be disposed within the housing 14 adjacent the liquid tank assembly 32 (shown in FIG. 7). Alternatively, the liquid reservoir 62 may be exteriorly mounted to the exterior-side housing wall 20 (shown in FIG. 1). Irrespective of its positioning, the important concept to be derived is that the reservoir 62 fluid communicates with the liquid compartment 46 for providing additional liquid 48 thereto when needed. To establish fluid communication, any elongated and tubular structure 66 such as a conduit may be used to form a reservoir channel 66 between the reservoir 62 and the liquid compartment 46 . In this respect, the liquid reservoir 62 ensures that the liquid 48 within the liquid compartment 46 is always kept at a certain level which is sufficient to provide adequate evaporation. [0039] [0039]FIG. 6 illustrates a baby wipes warmer 70 which is constructed in accordance with a second preferred embodiment. The second embodied baby wipes warmer 70 is substantially identical to the first embodiment with one major distinction. More specifically, the baby wipes warmer 70 of the second embodiment eliminates the use of the liquid tank assembly 32 . Rather, its interior-side housing wall 72 is adapted to define a substantially flattened interior compartment surface 74 which extends generally parallel to the base member 18 . By merely closing the top lid member (not shown), an inside compartment 78 is formed. A quantity of liquid 80 is directly contained within this compartment 78 . [0040] A support surface 82 which is defined by a suspension tray 84 is disposed within the inside compartment 78 . However, it should be noted that the support surface 82 is positioned above the pool of liquid 80 as it must accommodate the baby wipes 12 thereon. The support surface 82 may be engaged upon the interior. compartment surface 74 through any known process such as bonding or fastening. By utilizing this arrangement, the baby wipes 12 are adequately heated while sustaining their moisture and color through vapors 86 rising from the heated liquid pool 80 disposed immediately underneath the support surface 82 . [0041] [0041]FIG. 7 shows a baby wipes warmer 90 which is made in accordance with a third preferred embodiment of the present invention. This warmer 90 is substantially identical to the first embodied baby wipes warmer 10 except that its liquid tank assembly 92 is fabricated in the form of an elongated central channel and is embedded laterally along the interior compartment surface 94 . This elongated central channel serving as the liquid tank assembly 92 includes a sponge 96 within its liquid compartment 98 . The sponge 96 operates to draw the liquid 100 out of the adjacently located liquid reservoir 102 by capillarity. Similar to the tank assembly 32 of the first embodiment, its upper tank surface 104 includes a plurality of vapor holes 106 which allow the liquid 100 to evaporate therethrough. [0042] The operation of the first embodied baby wipes warmer 10 is described herein which is simultaneously representative for operations of the second and third embodied baby wipes warmers 70 , 90 . First, a stack of baby wipes 12 to be warmed is placed within the inside compartment 30 simply by opening and then closing the lid member 26 . The liquid 48 contained within the baby wipes warmer 10 should be checked to ensure that there is sufficient level present for adequate evaporation. This can be accomplished by visually checking the liquid reservoir (for the first and third embodiments) or the liquid level within the inside compartment itself (for the second embodiment). Thereafter, the baby wipes warmer 10 should be plugged into an electrical outlet (not shown) in order to activate the heating element 60 (if not already done). By following this easy-to-follow procedure, portions of the liquid 48 can transition into vapors 49 when sufficiently heated which are then provided to the baby wipes 12 so that they may be maintained in constant moisturized condition and coloration. [0043] Additional modifications and improvements of the present invention may also be apparent to those of ordinary skill in the art. Thus, the particular combination of parts described and illustrated herein is intended to represent only certain embodiments of the present invention, and is not intended to serve as limitations of alternative devices within the spirit and scope of the invention.

1a

BACKGROUND [0001] 1. Field of the Invention [0002] The present invention relates generally to solar lighting systems and in particular to a solar lighting system adapted for use on a patio umbrella. [0003] 2. Description of Related Art [0004] Within the solar lighting industry, and in particular within the outdoor solar lighting market, there are many designs for increasing the ambient lighting o patios and in back yards. Some of these are related to umbrellas, such as the Kuelbs references, but are complex solutions that are not easily fitted to a wide variety of umbrella designs. [0005] Therefore, there is a need in the solar outdoor lighting market for an umbrella lighting system that is easily adapted to existing designs and provides additional ambient lighting on a patio or wherever a patio umbrella may be used. [0006] All references cited herein are incorporated by reference to the maximum extent allowable by law. To the extent a reference may not be fully incorporated herein, it is incorporated by reference for background purposes and indicative of the knowledge of one of ordinary skill in the art. BRIEF SUMMARY OF THE INVENTION [0007] The problems presented in solar lighting industry are solved by the systems and methods of the present invention. In accordance with one embodiment of the present invention, an umbrella lighting system is provided. The umbrella lighting system of the embodiment shown includes a power system mounted to a rib of an umbrella by a mounting system and conductively connected to a lighting system. [0008] Other objects, features, and advantages of the present invention will become apparent with reference to the drawings and detailed description that follow. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a view of an umbrella lighting system; [0010] FIG. 2 is a detail of the power system and fixing device of the umbrella lighting system shown in FIG. 1 ; [0011] FIG. 3 is view of another umbrella lighting system having decorative globe light fixtures; and [0012] FIG. 4 is a view of another umbrella lighting system having decorative lantern light fixtures. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0013] All references cited herein are incorporated by reference to the maximum extent allowable by law. To the extent a reference may not be fully incorporated herein, it is incorporated by reference for background purposes and indicative of the knowledge of one of ordinary skill in the art. [0014] In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific preferred embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is understood that other embodiments may be utilized and that logical mechanical and electrical changes may be made without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the invention, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims. [0015] Referring now to FIG. 1 of the drawings an umbrella lighting system 10 is shown. Umbrella lighting system 10 has a solar power system 12 supported by a fixing device 14 . Solar power system 12 is in electrical communication with a conductive connection 16 that is in turn in electrical communication with a lighting system 18 . As is clearly shown in this view, fixing device 14 is connected to a lower end of umbrella rib 20 that is in turn supported by center pole 22 , as is typical in patio umbrellas generally. [0016] Lighting system 18 includes brackets 40 attached to ribs 20 at intervals to support light bulbs 50 along ribs 20 . Wires 42 are shown running along a top side of ribs 20 to connect light bulbs 50 to power system 12 . [0017] FIG. 2 is a detail of the power system and fixing device of the umbrella lighting system shown in FIG. 1 . Power system 12 includes a solar panel 24 and battery 26 . Solar panel 24 charges battery 26 during daylight hours and battery 26 powers lighting system 18 when illumination is desired. A switch 28 may be included on power system 12 to control the power going form battery 26 to lighting system 18 . Also, a photo resistor 30 may be used to detect ambient lighting and allow power to go from battery 26 to lighting system 18 after dusk. [0018] Continuing with FIG. 2 fixing device 14 is comprised of an arm 32 and a sleeve 34 . Sleeve 34 is placed over the lower end of umbrella rib 20 and secured to umbrella rib 20 by a threaded housing pin 36 attached to a movable hold-down plate 38 . Movable hold-down plate 38 allows sleeve 34 to be secured to a variety of different sizes of rib 20 . Arm 32 is shaped to position power system 12 above umbrella rib 20 for exposure to sunlight. Power system 12 is pivotally attached to arm 32 to allow solar panel 24 to be adjusted for maximum exposure to sunlight. [0019] The primary advantage of fixing device 14 is that it may be slid over rib 20 . In a typical arrangement, the umbrella cover may be removed from the tip of a single rib without further disassembly of the umbrella, allowing fixing device 14 to be slid over rib 20 and secured to rib 20 by plate 38 and pin 36 . [0020] FIG. 3 is view of another umbrella lighting system 10 having decorative globe light fixtures 44 hanging from the tips of ribs 20 . Hooks 48 secure globe light fixtures to ribs 20 . Light fixtures 44 include light bulbs 50 and provide for wires 42 to run between light bulb 50 and power system 12 . In the embodiment shown wires 42 run along the tops of ribs 20 . Further, in the embodiment shown two power systems 12 are used on ribs 20 . The use of multiple power systems 12 provides for additional power and for improved distribution of weight, since batteries 26 may be heavy depending on the amount of light output desired from bulbs 50 . [0021] FIG. 4 is a view of another umbrella lighting system having decorative lantern light fixtures 44 . As above, light fixtures 44 include light bulbs 50 . Additionally, wire 42 is shown running from rib 20 to rib 20 from tip to tip along a support wire 46 . In this case wire 42 may be a coiled wire, as shown, to be used on different length ribs 20 . [0022] The primary advantage of the present invention is that the system may be adapted to fit a wide variety of umbrellas or may be built for one specific umbrella design. The lighting system can be used with solid pole patio umbrellas without requiring external wiring on the pole because the power system and associated controls are accessible to the user at the lower end of the umbrella rib, yet unobtrusive. Further, the power system maybe easily removed for storage or maintenance without disassembling the umbrella. Additionally, the lighting system may be offered as a separate add-on for a line of umbrellas with optional lighting designs, thereby allowing the customer to choose an umbrella and lighting combination that meets the customers needs without having to anticipate and provide every possible combination. [0023] It should be apparent from the foregoing that an invention having significant advantages has been provided. While the invention is shown in only a few of its forms, it is not just limited but is susceptible to various changes and modifications without departing from the spirit thereof.

1a

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 10/654,723 filed Sep. 4, 2003 which is a continuation of U.S. provisional Application No. 60/409,305 filed Sep. 9, 2002. BACKGROUND OF THE INVENTION [0002] 1. Technical Field [0003] The subject invention relates to a method of transferring a specific immune response into a cloned animal. In this manner, one may create a specific, selective, secondary immune response in an otherwise immunologically naive animal. BACKGROUND INFORMATION [0004] Cloned animals have been utilized for many years in order to produce genetically engineered proteins or factors. In particular, such proteins or factors are expressed in the founder animals and transmitted to the clone. In this manner, one may expand the source of the product of interest as well the supply thereof. [0005] The immune response is a learned and thus adaptive response whereby, following antigenic exposure, cells of the immunized animal undergo a series of stimulation and maturation steps before producing the final product, whether it is a receptor or an immunoglobulin (i.e., antibody) molecule. Therefore, a cloned animal, though genetically predisposed, may or may not necessarily produce the same receptor or antibody specificity upon immunization with the same immunogen, as the founder. Transfer of immune potential from founder to clone, in accordance with the method of the present invention, will substantially increase the opportunity for the expression of those specific immune responses. [0006] Adoptive transfer has been demonstrated for a) identical twins (animals and humans), b) genetically identical individuals of the same species (e.g., highly inbred mice) or, c) genetically close individuals (such as for bone marrow transplants, kidney and other organ donor programs). In the latter case, success is influenced by how close the genetic “match” is (or by how small the “mismatch” is) and by instituting adequate chemotherapy and radiation regiments. However, adoptive transfer, such as that encompassed by the present invention involves quite a different method and has many advantages. SUMMARY OF THE INVENTION [0007] The present invention includes a method of transferring an immune response from a founder mammal (e.g., animal) to a cloned mammal (e.g., animal). This method comprises the steps of: a) immunizing a founder mammal with an immunogen; b) cloning the founder mammal; and c) obtaining lymphocytes from the immunized founder mammal and transferring the lymphocytes to the cloned mammal for a time and under conditions sufficient for the mammal to develop the immune response of the founder mammal. The mammal (e.g., animal) may be selected from the group consisting of mice, rabbits, sheep, dogs, cats, horses, pigs and cows. The lymphocytes may be, for example, peripheral blood lymphocytes, lymph node lymphocytes, splenocytes or bone marrow cells. Such lymphocytes may be transferred by transfusion, for example. The immunogen may be any entity capable of eliciting or producing an immune response (e.g., production of antibodies). Examples of suitable immunogens include antigens, epitopes and haptens. The cloning itself is from, for example, somatic cells or embryonic stem cells. Cloning may be achieved by transferring the nucleus from a somatic or embryonic stem cell of the founder animal to an enucleated ovum of a surrogate female, and implanting the resulting ovum into the uterus of the surrogate female during estrous. BRIEF DESCRIPTION OF THE FIGURES [0008] [0008]FIG. 1 illustrates the method of the present invention in which cells are isolated and purified from the founder animal, the cloned animal is prepared for adoptive transfer, and the transfer is completed. DETAILED DESCRIPTION OF THE INVENTION [0009] As noted above, an animal may be cloned; however, the ability of a cloned animal to make a particular antibody having a particular specificity is a learned response. Furthermore, the cloning process has not been demonstrated to also transfer the immunologic memory from the founder animal to the cloned animal. Therefore, in order to increase the odds in favor of producing a cloned animal with the capability to produce the desired antibody having a defined specificity, a different methodology must be utilized such as that of the present invention. [0010] In particular, the present invention encompasses a method whereby lymphoid cells or lymphocytes (e.g., from whole blood, blood-derived cells, peripheral blood lymphocytes, splenocytes, lymph node lymphocytes or bone marrow cells including stem cells) may be obtained from an animal (i.e., the founder) having a desirable immunological profile (e.g., the demonstrated ability to produce an antibody having a particular specificity). A founder animal is one that is known, following experimentation, to produce a unique immune response that is difficult to duplicate in other animals of the same or different species. Fresh whole blood or cells derived from blood, lymphatic tissue or bone marrow are then suspended in freeze media containing nutrients (e.g., fetal calf serum) and DMSO (dimethyl sulfoxide) as a cryoprotectant and stored frozen in liquid nitrogen. Once a cloned animal is available (created by using the founder animal), it may then be injected with fresh or preserved cells from the founder animal. Since the transfused cells are genetically identical to the clonal host or founder animal, they should not invoke immune rejection and are expected to successfully repopulate the lymphoid organs in the host or cloned animal. As such cells contain immunologically competent memory cells, the stimulation thereof in the cloned animal, by in vivo challenge, will produce the desired anamnestic immune response of the founder animals. [0011] The need for the present invention is significant. Such a need may be, for example, illustrated as follows: [0012] An essential and critical component of a diagnostic assay for T4 is sheep anti-T4 serum that is immobilized onto a solid phase (e.g., microparticles). In combination with a conjugate made up of T3 (Triiodothyronine, an analog of T4) and alkaline phosphatase, the sheep serum confers basic critical quality attributes required to generate a distinct standard calibration curve and allow for an estimate of FT4 in patient samples. [0013] The serum is developed by immunizing sheep with T4-Tg complex. Thyroxin (T4) is coupled onto a protein carrier molecule (porcine thryoglobulin or Tg), then emulsified in an adjuvant prior to injection into sheep. This is a classical approach to raising needed immune responses in experimental animals. Historically, however, this method of immunization produced antibodies recognizing T4 molecules; yet, in the great majority of instances, the resulting sera does not perform adequately in diagnostic tests. [0014] Success of adoptive transfer requires that the source and the destination animals either be genetically compatible (as in identical twins, clones, highly inbred species as is the case in some mice) or the recipient animal (destination) be immunologically suppressed through the use of chemical agents and radiation. [0015] It is not readily understood if such a rare and unique immune response is dictated solely by the animal's genetic background or to what degree the response is confounded by a variety of presently unknown factors. On the basis of theory alone, however, a large contributor to the uniqueness of such a response is the genetic make up of these responders. The low efficiency and unpredictable response is an obstacle to providing long-term resources and reagent safety stock and therefore jeopardizes the availability of test material. However, if an immunologic responder animal is cloned, in accordance with the present invention, the probability of raising a clone with immunologic potential similar to that of the founder animal is significantly enhanced. Moreover, the adoptive transfer of immunologically competent lymphoid cells from the founder to the clone will further enhance the opportunity of duplicating the immune competency of the founder animal without the risk of immune rejection. [0016] In view of the above, one purpose of the present invention is to produce a cloned animal with the same immune capacity and immunological identity, as the founder animal with respect to a specific antigen. The transfusion may be preceded by, followed by or concurrent with immunization and/or boosting by an immunogen that has been demonstrated to illicit a particular immune response to yield the desired antibody specificity. Other manipulations may also be attempted to increase the likelihood of producing the needed antibody depending on the success of this transfusion approach. For instance, one possible manipulation is to boost a sheep which has previously been immunized using T4-Tg immunogen, with T4 coupled to a different carrier molecule such as KLH (Keyhole limpet hemocyanin). [0017] The antibodies produced by the cloned animal may be used for many purposes. For example, the antibodies may be utilized in diagnostic assays as well as for therapeutic purposes. The present invention therefore will allow for the production of an endless supply of such antibodies without the concern of maintaining the desired immunological response of the founder animal. [0018] The present invention may be illustrated by the use of the following non-limiting examples: EXAMPLE 1 Adoptive Transfer of Immunity to a Cloned Animal [0019] Initially, fucosyl transferase transgenic mice (or a group of animals of the same species) are immunized with an antigen such as T4-TG. The immunized mice are then cloned using fibroblast cells as nuclear donors. At adulthood, the cloned mice are then divided into two groups. Immune splenocytes from the immunized mice are then obtained and transferred to the Group I mice (Adoptive Transfer Group). In contrast, naïve splenocytes are obtained from un-immunized mice and transferred to Group II (Negative Control Group). Both groups of mice are challenged with T4-TG antigen. The antibody response or titer produced against the T4 hapten is measured in both groups and compared. [0020] If adoptive transfer is successful, Group I mice (animals transfused with immunologically trained cells) show a secondary immune response (high titer specific) while Group II mice (animals transfused with immunologically naïve cells) show only a primary immune response (low titer and less specific), such as in vaccination. In particular, a vaccine is designed to train the immunologically naïve cells to become “educated” immune cells. Once immune (or educated) cells counter a real infection, they respond more rigorously (e.g., higher antibody level, i.e., higher titer) and more specifically than an otherwise un-educated or naïve cell.

1a

This is a continuation of application Ser. No. 775,650 filed Sept. 13, 1985, now abandoned. FIELD OF THE INVENTION This invention relates to a surgical implant and, more particularly, relates to a dorsal transacral surgical implant. BACKGROUND OF THE INVENTION Surgical implants are well known, and such implants have been heretofore used as spinal fixation devices in correcting deviations of the spinal column, including scoliosis. Prior known devices for surgical implants have included the use of a pair of spinal rods for aligning a spinal column (see, for example, U.S. Pat. No. 4,369,769), and have also included rods having hooks or the like thereon engagable with vertebrae of the spinal column to achieve spinal alignment (see, for example, U.S. Pat. Nos. 4,361,141; 4,382,438; 4,404,967; 4,369,770; and 4,085,744). In addition, hook devices with locking means for securing hooking devices to a rod have heretofore been suggested in conjunction with surgical implants (see, for example, U.S. Pat. No. 4,433,676). Spinal implants have heretofore, however, not been found to be completely satisfactory, at least for some applications, due, for example, to inability of the implant to resist rotation, inability of the implant to sufficiently stabilize the spinal column, and/or inability of the implant to maintain the structural integrity of the implant over a period of time. It is also been heretofore suggested that screws could be utilized in connection with spinal implants (see, for example, U.S. Pat. No. 4,041,939), and a sacral anchor has been heretofore suggested for a surgical implant for use in correction of scoliosis (see, for example, U.S. Pat. No. 4,047,523). There still remains, however, a need for an improved surgical implant, including a firmly anchored implant for satisfactory aligning and stabilizing the spinal column, and particularly the lumbosacral junction. SUMMARY OF THE INVENTION This invention provides an improved surgical implant for correcting and supporting the spinal column. The implant includes a base plate directly mounted on the sacrum for firmly anchoring a pair of rods extending therefrom, which rods have securing elements thereon engagable with vertebrae of the spinal column to be corrected for causing the spinal column ot assume a contour similar to that of the particular rods utilized. The rods are locked in sockets on the base plate and the securing elements are locked on the rods to assure against independent movement, including rotation, and with the resulting device having sufficient structural integrity to stabilize the spinal column and remain intact over long periods of use. It is therefore an object of this invention to provide an improved surgical implant. It is another object of this invention to provide an improved surgical implant for correction and support of a spinal column. It is another object of this invention to provide an improved surgical implant that is dorsally placed and transacrally fixed. It is another object of this invention to provide an improved surgical implant that is useful for aligning and stabilizing the spinal column and particularly the lumbosacral junction. It is another object of this invention to provide an improved surgical implant that includes a base plate fixed to the sacrum and a pair of rods received in sockets on the base plate. It is another object of this invention to provide an improved surgical implant that includes a pair of spaced rods having securing means engagable with vertebrae of the spinal column to align and stabilize the spinal column. It is another object of this invention to provide an improved method for implanting a spinal correction and supporting device that is to be dorsally placed and transacrally fixed. With these and other objects in view, which will become apparent to one skilled in the art as the description proceeds, this invention resides in the novel construction, combination, arrangement of parts and method substantially as hereinafter described, and more particularly defined by the appended claims, it being understood that changes in the precise embodiment of the herein disclosed invention are meant to be included as come within the scope of the claims. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings illustrate a complete embodiment of the invention according to the best mode so far devised for the practical application of the principles thereof, and in which: FIG. 1 is a perspective view of the surgical implant of this invention; FIG. 2 is a perspective view of the hook element shown in FIG. 1; FIG. 3 is a perspective view of the wedge used to lock the hook element onto a rod as shown in FIG. 1; FIG. 4 is a perspective view of a bridging element as shown in FIG. 1; FIG. 5 is a perspective view of a yoke and foot element as shown in FIG. 1; FIG. 6 is a partial perspective view of the lower portion of one of the rods as shown in FIG. 1; FIG. 7 is a perspective view of the wedge used for locking the rod in the socket in the base plate as shown in FIG. 1; FIG. 8 is a cross-sectional view of the rod taken through lines 8--8 of FIG. 6; FIG. 9 is a partial sectional view of the rod taken through lines 9--9 of FIG. 6; FIG. 10 is a rear view showing the surgical implant of this invention in place to support and correct a typical spinal column; FIG. 11 is a side view taken through lines 11--11 of FIG. 10 illustrating the alignment and support provided by the implant; FIG. 12 is a partial lower end view taken through lines 12--12 of FIG. 11 illustrating placement of the base plate on the sacrum; FIG. 13 is a partial sectional view taken through lines 13--13 of FIG. 12 illustrating one of the rods locked in the socket in the base plate; FIG. 14 is a cross-sectional view taken through lines 14--14 of FIG. 13 illustrating locking of the rod in the socket by the wedge; FIG. 15 is a partial sectional view taken through lines 15--15 of FIG. 12 illustrating TSF 1 screw placement in the sacrum; FIG. 16 is a partial sectional view taken through lines 16--16 of FIG. 12 illustrating TSF 2 screw placement in the sacrum; FIG. 17 is a partial sectional view taken through lines 17--17 of FIG. 12 illustrating TSF 3 screw placement in the sacrum; FIG. 18 is a sectional view taken through lines 18--18 of FIG. 11 illustrating the yoke and foot element with the foot portion engaging vertebrae to facilitate alignment of a spinal column; FIG. 19 is a partial sectional view taken through lines 19--19 of FIG. 18; FIG. 20 is a partial sectional view taken through lines 20--20 of FIG. 11 illustrating use of a bridging element and associated wiring utilizable in aligning a spinal column; FIG. 21 is a partial sectional view taken through lines 21--21 of FIG. 20; FIG. 22 is partial sectional view taken through lines 22--22 of FIG. 11 illustrating use of a hook element to engage vertebrae; and FIG. 23 is a partial sectional view taken through lines 23--23 of FIG. 22. DESCRIPTION OF THE INVENTION To achieve a satisfactory implant, this invention utilizes, as shown in FIG. 1, a base plate 27 having a pair of rods 28 and 29 received in sockets 30 and 31, respectively, mounted on the base plate. Base plate 27 is preferably a contoured, slightly malleable implant made from stainless steel (as are all other components utilized in the implant). The center portion 33 of the base plate has an upwardly extending ridge 34 thereat with sockets 30 and 31 being positioned parallel to and along the opposite sides of the ridge. Sockets 30 and 31 are tubular sections which are fastened to the top side of the base plate in a conventional manner, such as, for example, by welding. Projections, or wings, 36 and 37 extend outwardly from center portion 33 and each projection has three apertures thereon (designated as apertures 39, 40 and 41 in projection 36 and apertures 43, 44 and 45 in projection 37) formed near the outer edges, which edges are shown curved at the front portion (at apertures 39 and 43). It is to be realized, however, that the curvature of the base plate, depends upon the particular sacrum and/or particular fixation to be utilized, as brought out more fully hereinafter. Rods 28 and 29 are also preferably formed of stainless steel, and are contoured as needed for each particular application. The system is a total system, and may utilize one or more types of securing elements for securing vertebrae of the spinal column along the rods. As shown in FIG. 1, by way of example, each rod 28 and 29 may have a hook element 47 thereon, which hook element, as shown in FIGS. 1 and 2, includes a body portion 48 having a bore 49 therethrough through which the associated rod extends with the bore being slightly larger than the diameter of the rod to enable free axial and rotational movement of the rod in the bore. Hook portion 50 extends below the body portion, and, as shown in FIG. 3, a tapered wedge 51 with head 52 thereon, is utilized to engage the rod extending through the bore to lock the hook element against movement (including precluding rotation and axial movement) independently of the rod. As indicated in FIGS. 2 and 3, bore 49 and wedge 51 are lengthwise serrated, to that upon final placement, sufficient pressure can be applied to cold weld the components in position. Rods 28 and 29 are maintained in spaced relationship with respect to one another by use of bridging element 54, as shown in FIGS. 1 and 4. As shown, bridging element 54 includes outwardly facing arcuate sections 55 and 56 (the inner surfaces 57 of which are lengthwise serrated) having a V-shaped strut 58 therebetween, with the inner surfaces 57 of arcuate sections 55 and 56 engaging the inner portions of rods 28 and 29 when the bridging element is positioned between the rods, as indicated in FIGS. 1, 10, 20 and 21 of the drawings. As shown in FIGS. 1 and 5, a yoke and foot element 59 may also be placed between rods 28 and 29. Element 59 includes a pair of outwardly facing arcuate sections 60 and 61 (the inner surfaces 62 of which are lengthwise serrated) at opposite sides of block 63 with the inner surfaces 62 of the arcuate sections 60 and 61 being engagable with the inner portions of rods 28 and 29 when positioned between the rods, as shown in FIGS. 1, 10, 18 and 19 of the drawings. Block 63 has a bore therethrough for receiving a threaded shank 64, which shank has a foot, or hook, 65 at one end. As indicated, foot 65 is tapered toward the front, or freely extending edge, of the foot to facilitate insertion adjacent to a vertebra or the like. Shank 64 has nut 66 thereon adjacent to block 63 at the side opposite foot 65 so that upon rotation of nut 66, foot 65 can be drawn toward or moved away from block 63 (or, alternately, the bore of block 63 can be threaded so that the foot is drawn toward or moved away from the block by rotation of the shank, and nut 66 can be used to lock the shank in place with respect to the bore). As shown best in FIG. 6, rod 28 (rod 29 is identical and therefore not separately discussed) has a body portion 67 that terminates at shoulder 68 with a reduced diameter end portion 69 extending therefrom, which end portion is lengthwise serrated and is received in socket 30 (as shown in FIGS. 1, 12 and 13), the inner surface of which is also lengthwise serrated (as is socket 31). A wedge 71 (likewise lenghtwise serrated) having head 72 thereon, as shown in FIGS. 1 and 7, is used to lock the rod in the shaft so that, when so locked, the rod cannot rotate and the rod is therefore constrained to movement with the base plate. As shown in FIGS. 8 and 9, rod 28 has threads 74 formed thereon, with the threads being flat topped, as indicated in FIG. 9, to lessen the cut into the rod so as to maintain maximum strength, and each thread has lengthwise serrations 75 therein. The threads are 20 per inch which allows small changes in the locking points for the securing elements along the rods (of about 1 mm). Typical use of the implant of this invention is shown in FIGS. 10 and 11. It is meant to be emphasized that while only one bridging element, yoke and foot element, and hook element has been shown in FIGS. 10 and 11, any number of each could be utilized as might be needed for a particular application. In addition, the use of wire could be expanded, and pedicle screws (not shown) could also be utilized. As shown in FIGS. 10 and 11, base plate 27 is mounted on sacrum 78 of the spinal column 79 of the body and contoured rods 28 and 29, when positioned in sockets 30 and 31 (as shown in FIGS. 12 through 14), extends along the vertebrae 80 of spinal column 79 so that such vertebrae can be secured to rods 28 and 29 to cause alignment of the spinal column and thereafter support the aligned spinal column in the manner generally dictated by the contour of the rods. The sacrum offers several possibilities for fixation, which, when combined, appear to provide a secure foundation for a dorsally placed transacrally fixed implant. The dorsal sacral landmarks, and particularly the first and second dorsal foramina, are readily identifiable and relate in a consistent manner both qualitatively and quantitatively to the major mass of the sacral bone, which is located ventrally to the vital structures of the sacrum. Ideal lumbosacral fixation should secure directly to the sacrum rather than indirectly by way of the iliae, and be modular for ease of insertion, versatile to allow use in a wide variety of diseases and deformities, and integratable with existing and evolving cephalad spine implants. The sacral foundation of this invention provides a dorsal sacral implant that is secured ventrally by multiple transacral anchors. To determine the best configuration for such a sacral implant, implant configuration and transacral fixation site possibilities were first studied on a variety of anatomical models and four embalmed cadaver specimens. To study contour, plaster of Paris negative and laminated paper positive molds were prepared and from these 0.5 mm (0.02 inch) thick stainless steel prototypes were prepared. To study transacral anchor possibilities, drill holes were placed in six different sites. The placements were selected to safeguard neurovascular structures, avoid sacroiliac articulations, and provide maximum bone fixation. The three dimensional placement of the drill sites was confirmed by Faxitron radiography. The relative strength of fixation site combinations was also estimated in the embalmed human sacrae and in fresh calf sacrae using hand held spring scales. To study the dimensions of the dorsum of the first two sacral vertebral segments, and the depth of the transacral fixation sites, 18 cadaver sacrae of known sex (9 males and 9 females) and 31 sacrae of unknown sex were measured with calipers. In addition, anthropometric sacral dimensional measurements were determined in the 18 sacrae of known sex. Student t-test and linear correlation coefficient analyses, where appropriate, were also performed. To study the effect of transitional vertebrae on sacral configuration, 8 sacrae so involved were studied. The transacral fixation depths and dorsal sacral measurements of the 18 sacrae of known sex are tabulated in Tables 1 and 2 as follows: TABLE 1______________________________________TRANSACRAL FIXATION (TSF) DEPTH Distance (mm)Males (9) Females (9) P______________________________________TSF 1 49.7 (±3.7) 46.9 (±3.3) NSTSF 2 38.8 (±2.7) 37.2 (±2.5) NSTSF 3 30.7 (±3.1) 28.8 (±2.3) NS______________________________________ TABLE 2______________________________________HUMAN SACRUM: DORSAL MEASUREMENTS Distance (mm) Males (9) Females (9) P______________________________________S1DF to S1DF 48.8 (±5.0) 47.4 (±3.8) NSS2DF to S2DF 43.1 (±4.2) 44.0 (±3.0) NSS1DF to S2DF 26.2 (±2.4) 21.4 (±2.5) <.001SN to S1DF 21.7 (±2.3) 22.3 (±1.6) NS______________________________________ LEGEND: S1DF = First Sacral Dorsal Foramen S2DF = Second Sacral Dorsal Foramen SN = Superior Sacral Notch of the Sacral ALA The longest, and apparently most secure, transacral fixation site was previously described by Harrington and Dixon (Harrington, P. R. and Dixon, J. H. "Spinal instrumentation in the treatment of severe progressive spondyloisthesis", Clin. Orthop. 117:157-163, 1976) and passes through the first sacral pedicle to the sacral prominatory (TSF 1). The dorsal entry point is caudad and lateral to the superior facet, 10 mm lateral and five mm cephalad from the first sacral dorsal foramen. The direction with reference to a staring line perpendicular to the flat dorsal surface of the first and second sacral laminae was 15 degrees cephalad in the frontal plane, 20 degrees cephalad in the sagittal plane, and 35 degrees medially in the horizontal plane. Access to the entry site necessitated a dowel cut window 81 in the iliac crest 82 (as indicated in FIG. 10). The TSF 1 depth was 49.7 mm (±3.7) in the nine males and 46.9 mm (±3.3) in the nine females. It was not significantly different than the distance between the outer edges of the first sacral dorsal foraminae (S1--S1) which was 48.8 mm (±5.0) in males and 47.4 mm (±3.8) in females. The distance from the superior sacral notch of the sacral ala to the cephalad edge of the first dorsal sacral foramen was similar for males, 21.7 mm (±2.3) and females, 22.3 mm (±1.6). The distance between the cephalad edges of the first and second dorsal sacral foramina was significantly shorter in females, 21.4 mm (±2.5), than in males, 26.2 mm (±2.4), (p <.001). A common measurement used to separate male and female sacrae, a ratio of the transverse diameter of the first sacral body to the breadth of the sacrum, was not significantly different, males 41.9 (±3.2), and females 39.8 (±3.3), as shown in Table 3 as follows: TABLE 3______________________________________HUMAN SACRUM: CEPHALAD EDGE MEASUREMENTS DISTANCE MALES (9) FEMALES (9)______________________________________TRANSVERSE 43.7 mm (±3.9) 42.4 mm (±4.4) NSDIAMETERS1 BODY (TB)ANTERIOR 104.0 mm (±6.9) 106.4 mm (±4.7) NSBREADTH ATS1 (BRD)TB/BRD × 100 41.9 (±3.2) 39.8 (±3.3) NS______________________________________ The distance between the outer edges of the second dorsal sacral foramina was similar, males 43.1 mm (±4.2) and females 44.0 mm (±3.0). Of the five additional transacral fixation sites studies, two appear superior. One (TSF 2) transversed from the first sacral transverse tubercle to the lateral mass of the sacrum. The direction with reference to a staring line perpendicular to the flat dorsal surface of the first and second sacral laminae was 25 degrees cephalad in the frontal plane, 25 degrees cephalad in the sagittal plane, and 25 degrees lateral in the horizontal plane. This distance was similar for males, 38.8 mm (±2.7), and females, 37.2 mm (±2.5). The other site (TSF 3) passed from a point midway between the intermediate and lateral sacral crest and midway between the first and second dorsal foramina to the lateral mass. The TSF 3 direction with reference to a starting line perpendicular to the flat dorsal surface of the first and second sacral laminae was 20 degrees caudad in the frontal plane, five degrees caudad in the sagittal plane, and 50 degrees lateral in the horizontal plane. This distance was similar for males, 30.7 mm (±3.1) and females, 28.2 mm (±2.3). For the 49 normal sacrae studied, without regard to sex, there was a positive correlation between the first sacral dorsal interforaminal distance and TSF 1 depth (p <0.001), between TSF 1 depth and TSF 2 depth (p <0.005), and between TSF 1 depth and TSF 3 depth (p <0.001), as shown in Table 4 as follows: TABLE 4______________________________________DORSAL AND TRANSACRAL FIXATION SITEMEASUREMENT CORRELATIONS:WITHOUT REGARD TO SEX (N = 49) P______________________________________S1DF--S1DF vs. TSF 1 .5297 <.001TSF 1 vs. TSF 2 .4137 <.005TSF 1 vs. TSF 3 .5294 <.001______________________________________ LEGEND: S1DF = FIRST SACRAL FORAMEN TSF = TRANSACRAL FIXATION There were eight sacrae with transitional vertebrae, five had complete sacralization of L5 with the lateral mass appearing to coincide with the "new" S1 vertebrae, and three had imcomplete sacralization of L5 and the lateral mass coincided with the true S1 vertebrae. In these, as well as in the one sacrum with complete lumbarization of S1, the TSF 1 distance was relatively short. Although there are significant sex and race related differences in the anthropometry of the human sacrum, these differences are small, approximately 5 to 6 mm. In the study, for the implant of this invention, the major sex difference was not in the S1 body/sacral breadth ratio, but in the spacial relations of the first and second dorsal sacral foramina, the distance being shorter in females. However, the relatively large S1 pedicle approach to the prminatory appears to offer adequate compensation for this difference in an implant with fixed distance fixation entry sites. While interracial differences were not considered, they appear to be less significant than the intersex differences. Thus, design of sacral implants based on sex and race differences does not appear to be necessary. As a result of these studies, the dorsal sacral implant of this invention has been designed to meet the implant needs and requirements for sacral fixation. To achieve sacral fixation, base plate 27 is secured on sacrum 78 by means of screws 84 (are more specifically designated as screws 84a-84f as shown best in FIGS. 12, 15, 16 and 17). The positioning of screws 84a and 84d are best shown in FIGS. 12 and 15, while the positioning of screws 84b and 84c are best shown in FIGS. 12 and 16, and the positioning of screws 84c and 84f are best shown in FIGS. 12 and 17. As can be appreciated from FIGS. 12 and 15 through 17, the screws are placed in a three-dimensional configuration in the sacrum with the location and angles being predetermined, as brought out hereinabove, to provide maximum retention of the base plate on the sacrum even though severe forces might be later applied thereto. After the base plate is fixed to the sacrum, and after the rods are contoured to the desired contour needed for the particular subject, the rods are placed in sockets 30 and 31 and when so placed, wedges 71 are driven into the space between the rods and sockets as shown in FIGS. 13 and 14, with the serrated surfaces maintaining the wedges in place (preferably the wedges are wired in place to give even more protection against dislodging by later patient movements). The body, or main, portions of rods 28 and 29 are utilized to secure spinal column 79 in the desired position and alignment dependent upon the curvature of the rods, with the vertebrae of the spinal column being secured to the rods as generally shown in FIGS. 10 and 11, and as more specifically shown in FIGS. 18 to 23. As shown, rods 28 and 29, when finally positioned, are adjacent to the lamina 86 of vertebrae 80 of spinal column 79 with the rods having the spinous process 87 of the vertebrae between the rods. As shown, hook elements 47 on rods 28 and 29 are utilized to engage vertebrae 80 of spinal column 79 with hooks 50 engaging the underside of a vertebra (above spinal cord 88) to maintain the vertebrae adjacent to the rods. Bridging elements 54 maintain rods 28 and 29 spaced, and vertebrae can be held in place adjacent to the spacing elements by wire 90, as needed. As shown, wire 90 may also be wrapped around rods 28 and 29 and bridging elements 54 as needed for maintaining the positioning of the bridging elements. Yoke and foot elements 592 are utilized with foot 65 hooked under a vertebra 80 so that the vertebrae can be lifted or otherwise moved toward the rods by lengthening or shortening the shank relative to the spacer block. All removable elements (including wedges) are preferably wired in place upon final implant to assure against loosening and/or loss of any such element or component from its intended position. In performing the surgical implant, the sacral anatomy is preferably first defined, after which staged surgery (anterior disectomy and fusion if necessary to restore alignment and/or provide stabilization) may be carried out prior to sacral fixation. To prepare the sacral fixation, the sacrum is first exposed, measurements are then taken for determining the best positioning of the base plate on the sacrum, the site is thereafter prepared and sculptured, and the TSF 3 holes in each side of the base plate are located and drilled (25 mm ). The iliac crest entry portals are next located and drilled as necessary to provide the portals, and the TSF 1 holes are then located and drilled (45 mm ). The base plate is next placed into position on the sacrum, the TSF 2 holes are confirmed over the S1 transverse tubercle, the TSF 1 are then drilled, and screws are securely screwed into all of the drilled holes. After fixation of the base plate, lumbar and thoracolumbar fixation is carried out by selecting the correction mode to be utilized (distraction, compression, extension, flexion, rotation, or combination), preparing the proximal fixation sites, contouring the rods and placing the rods in the sockets of the base plate, wedging the rods in the desired position, and then placing the necessary securing elements on the rods to enable the spinal column to be secured in the desired shape by means of the hooks and/or wire utilized (with various instruments being utilized, as necessary, to facilitate the fixation). As an operation proceeds, the various securing elements used as hooks can be adjusted by removing the tapered wedges, where necessary, by utilizing the heads on the wedges to easily withdraw the wedges, and then moving the elements, after which the elements are again screwed in place. The hooks can, of course, be placed for compression or distraction. It is meant to be realized, that various elements and/or method steps as described herein, could be modified as would be obvious to one skilled in the art without departing from the intended scope of this invention. As can be appreciated from the foregoing, this invention provides an improved surgical implant and method that utilizes direct sacral fixation.

1a

RELATED APPLICATION [0001] This application is a continuation-in-part of U.S. application Ser. No. 14/014,328, entitled “Dynamic Bracket System” by Hessam Rahimi, filed Aug. 29, 2013, which claims the benefit of U.S. Provisional Application No. 61/819,536, entitled “Dynamic Bracket System” by Hessam Rahimi, filed May 4, 2013, and is a continuation-in-part of U.S. application Ser. No. 13/598,931, entitled “Dynamic Bracket System” by Hessam Rahimi, filed Aug. 30, 2012. [0002] The entire teachings of the above applications are incorporated herein by reference. BACKGROUND OF THE INVENTION [0003] Orthodontics is a specialty in dentistry that moves teeth within the jaw bone and straightens the teeth by moving them to the proper three-dimensional location. In orthodontics, brackets are pieces of metal with a slot that accepts a flexible or rigid metallic wire. Such brackets are conventionally bonded to the teeth on a base (via a frame) and serve as vehicles allowing the orthodontist to apply force to the tooth to move it across the wire to its proper location with the proper angulation. [0004] The interaction of force, wires and brackets guides the three dimensional movement of the tooth. The force applied to the teeth, by the wire, forces the teeth to slowly alter their positions to align with the wire and therefore position them correctly in three dimensions. [0005] Conventional brackets generally have a fixed slot wherein the position of the slot relative to the tooth is fixed. Historically, brackets were the same for all teeth, regardless of patient individuality. Since every tooth has a unique three dimensional relationship with the rest of the teeth, the orthodontist was required to bend the wire that passed across the bracket slot in order to correct tooth angulation for each individual tooth. [0006] In orthodontics, the angulation of the bracket slot in each dimension is described differently. The angulation of the bracket slot in the left-right direction is called ‘tip’ and the angulation of slot in the back-forward direction is called ‘torque’. An average tip and torque has been calculated for every tooth, based on studies of normal dentitions. A modification was presented a few decades ago by which specific brackets were created for every tooth according to their average angulations so that when a straight wire was passed through the slot, the difference between the angle of the straight wire and the angle of the slot would force the tooth to track the wire and achieve the proper angulation. However, the inaccuracies occurred when a bracket was not bonded to the proper location on the tooth, which led to an improper angulation of the tooth and ultimately to a misaligned tooth. [0007] Also, the presumed angulations are merely averages, based on estimates of average sizes and shapes of teeth. Each individual is different with varying morphology for their teeth. Whenever a patient's teeth do not fall within the normal range, the straight wire technique does not produce optimum tooth angulation and location. Commonly, brackets are not always placed in the proper location on the tooth resulting in erroneous bracket positioning. In order to correct for such problems, a certain number of brackets are repositioned during the course of the treatment to address these inaccuracies and improper bracket placements. Repositioning is both time-consuming and expensive and oftentimes does not cure the improperly positioned bracket. The process of bracket repositioning involves a patient's office visit, removal of the old bracket, polishing of the tooth surface, priming of the surface and application of the new bracket to the surface. This process can take anything from 5 to 15 minutes per tooth, depending on the location of the bracket and the experience of the clinician. [0008] A need exists for a dynamic bracket system that allows the clinician to change the angulation of the bracket to achieve proper tooth alignment. A further need exists for a dynamic bracket system that allows a change in angulation in a number of different directions. Yet a further need exist to do so using a system that is efficient, easy to adjust and cost effective. SUMMARY OF THE INVENTION [0009] The dynamic bracket system of the present invention is designed to equip the practitioner with the ability to conveniently modify the position, tip and torque of the bracket slot component during the course of treatment, without having to remove and rebond the bracket. The dynamic bracket system of the present invention increases efficiency and quality of patient care. A dynamic bracket system of the present invention includes a frame, bracket slot component, stationary cover, and a moving cover. The frame, with its textured bottom side, can be bonded to the tooth surface with an adhesive material. The bracket slot component (also referred to as the “bracket”) includes a base, a stem (also referred to as a “neck”) and the top portion of the bracket, which includes an upper arm, a slot, and a lower arm. In some embodiments, instead of upper arm and lower arm designations, the terms arm A, arm B, arm C, and arm D are used. [0010] In an embodiment, the bracket system uses friction to secure the slot component after it is repositioned. Within the bracket system, the stem, immediately below the top portion of the bracket, can be positioned within the bracket compartment opening, between the junction of the moving cover and stationary cover. In some embodiments, instead of a moving cover and a stationary cover, there is one receiving member that is part of a single piece frame. The bracket base can be secured by vertical pressure from the joining of the moving cover and stationary cover within the frame. The base of the bracket slot component, below the stem, can rest above the textured interior of the bracket frame. In an embodiment, the textured interior surface ensures that the bracket component does not move freely within the space created between bracket frame and the covers, or between the groove created between the receiving member and the anchoring member. The diameter of the bracket stem is smaller than the opening created by the covers such that the bracket stem fits within the opening. The base of the bracket slot component can be wider than the stem yet narrower than the frame. [0011] The dynamic bracket system, in an embodiment, also includes a stationary cover and a moving cover which slide into position within the bracket frame along guiding grooves in the interior side walls of the bracket frame. The guiding groove is an indentation that runs along the top interior edge of the frame. The ends of the stationary cover and moving cover are tapered to allow sliding of the moving cover over the stationary cover in the guiding groove. The horizontal force on the covers as the covers move towards the end of the grooves, sliding friction of the covers over one another, as well as vertical pressure on the base of the bracket combine to limit the movement of the covers. [0012] Each cover, in an embodiment that has such covers, has depressions at the exterior edge of the cover, which lock onto projections along the guiding groove of the frame. In this embodiment, the stationary cover and moving cover both have irregularly shaped interior edges. When the stationary and moving covers are in position within the bracket frame, an opening to the bracket slot compartment is created at the junction of the interior edge of the two covers. During initial assembly of the bracket, first, the stationary cover is guided into position within the bracket frame, along the guiding grooves. The stationary cover is locked into place when the depression on the stationary cover connects with the projection along guiding groove. [0013] The bracket slot component is inserted into the space between the cover and the frame so that the base of the slot component lies beneath the cover and the rest of the slot component lies above it. Finally, the moving cover is guided into position within the bracket frame until the depressions connect with the projections of the guiding groove. The bracket slot component is secured between the frame and the covers by the secure connection between the stationary cover and the moving cover. The covers are locked together by a locking mechanism such as ball and socket, key and key hole or force of friction. The guiding grooves are slightly wider than the width of the covers so that when the two covers come together, the stationary cover is pushed down as the moving cover is wedged between a side of the guiding groove and the stationary cover. Without the slightly wider guiding grooves, a positive pressure or force of friction could be more difficult to create so as to secure the covers. [0014] This design allows for the bracket slot component to be adjusted within the confines defined by the stationary cover and moving cover when the moving cover is in the ‘open’ configuration and not fixed in place. The bracket slot component locks in place when the moving cover is in the ‘lock’ configuration. The slot component is able to rotate 360 degrees as well as move within the range defined by the difference in radius of the stem and the opening to the bracket compartment (also referred to as the inner borders of the covers). The frame's exterior or tooth-side surface can be textured to increase bond strength. The tooth-side surface of the bracket frame can have adaptive curves associated with the morphology of tooth surface. The base of the stem and the base-side of the frame can have micro-depressions to prevent sliding of the slot when the moving cover is in lock position. This bracket system uses friction as a means to prevent alteration of position of bracket slot relative to the frame. [0015] The two covers have a locking mechanism when they meet that prevents the moving cover from opening unless subjected to horizontal force applied through a regular orthodontic plier to its opening ledge. When the two cover extensions meet, a positive downward pressure or force of friction is applied on the base of the slot component, locking it in place. This increased positive pressure is created as the sloped surface of the moving cover extension slides above the sloped surface of the stationary cover extension. The moving cover is held in place by the guiding grooves or narrow cut outs made in the inner surface of the walls of the base frame, allowing it to move back and forth in the horizontal direction. When the stationary cover is positioned in the frame wall's guiding groove, it will lock in place when pushed to the edge of the frame and the opposing socket in the stationary cover. The moving cover is locked in place when engaged with the stationary cover. The stationary cover and the moving cover are secured when the depressions on these covers are positioned within the projections in the guiding groove, at the exterior edge of the frame. The frame wall surrounds the bracket frame except the feeding wall where it allows for the base of the bracket compartment to slide underneath the covers. The moving cover has a notch close to the edge on the feeding side of the frame that prevents it from coming loose when the moving cover is open unless subjected to sufficient force from a human hand using a dental plier or other tool. When subjected to sufficient force, practitioner can replace the moving cover in cases where breakage happens or the practitioner is required to modify the slot configuration for any reason, whether it is damaged or a different torque number is required. [0016] The designs detailed above are some of the basic embodiments described herein that make use of covers. In addition to these, certain embodiments that do not need separate covers, and that can instead use integral parts of the frame itself, are also encompassed by the present invention. [0017] In an aspect, the present invention includes a bracket system for use as part of orthodontic braces. The bracket system has a frame and a bracket, in which the frame can be manipulated so that the bracket can be inserted into it, removed from it, and locked into it. Additionally, in some embodiments, the bracket comprises a base, a neck, and one or more arms. The base of the bracket is received by the frame, in part or in full, and the one or more arms can be shaped to create a slot that can receive a wire. In some embodiments, the exterior surface of the frame is textured so that it ensures that the friction between the tooth and the frame is high enough to prevent sliding. In other embodiments, the interior surface of the frame can be textured too, in addition to the bottom surface of the base. Such texturing can ensure that the lock between the bracket and the frame is stronger that what would have been achieved by the fastener, to be explained later, alone. In alternative embodiments, the bracket has four arms. These four arms can create two slots, for example. [0018] In some embodiments, the bracket system has a frame that comprises an anchoring member to anchor the frame to a tooth, a receiving member to receive a bracket, a hinge that connects the two members mentioned, an opening in the receiving member to accept a bracket, and a fastener to lock the relative positions of the receiving and anchoring members. In certain embodiments, the bracket within the frame can rotate around 360 degrees and it can also move in any direction along the 360 degrees. [0019] In a particular embodiment, the fastener of the bracket is a clip that exists as part of the single-piece forming the frame. The clip can have a stopper to stop a potentially dislocating receiving member. The clip can also have teeth that can align with teeth on the receiving member. The bracket system, in any of the embodiments, can be decorated with markings, either orthogonal to any of the sides or oblique to any of the sides, to facilitate alignment of the bracket and the frame with respect to each other. The markings can exist on both the bracket and the frame. [0020] In another aspect, an embodiment includes one or more screws as part of the fastener. The screws can be received by one or more screw receivers on the receiving member as well as on the anchoring member. The screw receivers on the anchoring member need not allow full passage of the screws; or if they do, they can be used in conjunction with screws that are designed with a specific length. In a separate embodiment, the fastener can be manufactured in the form of a lever. The lever can have a lever handle and a lever lock. The lever lock, when the handle is moved, can ensure that the receiving member and the anchoring member are tightly locked when a bracket is in place. [0021] In various embodiments, one or more components of the bracket system can be made, in part or in whole, from materials such as nickel-titanium alloys, titanium-molybdenum alloys, and/or stainless steel. The frame, in some embodiments, can be placed onto the facial (labial or buccal) side of a tooth, whereas, in others, it can be placed onto the lingual side of a tooth. In some embodiments, the brackets are self-ligating brackets or can be adapted to be self-ligating. [0022] In alternative embodiments, methods of using a bracket system are disclosed. One method includes the steps of anchoring the frame of a bracket system onto a tooth, placing a bracket into the frame, and fastening the frame to lock the bracket in place. Alternatively, the method of the present invention can include the steps of placing a bracket into a frame that has been anchored onto a tooth, and fastening the frame to lock the bracket in place. The steps of the method include unlocking the bracket, readjusting or re-positioning the bracket and locking the bracket into place. Various embodiments of such methods of using a bracket system can be modified in accordance with the embodiments of the bracket system disclosed herein. [0023] In a different embodiment, in addition to the frame and the bracket, a plate is provided. The plate, in terms of its function, serves a purpose analogous to that of the fastener in some of the other embodiments: it fixes (and unfixes) or “locks” or “unlocks” the relative positions of the bracket within the frame. In these embodiments, the frame is manufactured with side walls (e.g., 2 or 3 side walls), and thus has its anchoring and receiving members fixed in positions relative to each other. The side walls, in one sense, can be considered to be analogous to the hinge of some of the other embodiments; however, unlike the hinge, the side walls do not allow a similar flexibility within the frame. The anchoring member, receiving member and the side walls define a cavity in which, when in use, the plate and the bracket base reside. For locking the system, the plate is inserted into the front face opening in the frame and into the cavity. The plate is placed underneath the bracket base. The plate can be inserted fully or partially depending on how much pressure is desired to keep the bracket in place. In an embodiment, the plate has a tapered thickness in which the thickness is greater at the grip end of the plate, as compared to the insertion end. As the plate is slid into place through the front frame opening, the bracket base is locked into place when the thickness of the plate is about the same as the distance between the bottom of the bracket base and the top of the inner surface of the anchor member. Put another way, the height of the opening of the cavity is about equal to or greater, to the thickness of at least one point along the length of the plate plus the height/thickness of the bracket base. [0024] In these different embodiments, there no longer is a need for a separate fastener: the plate replaces the fastener. In addition, there no longer is a need for a hinge: the side walls replace the hinge, and the anchoring and receiving members of the frame no longer move substantially with respect to each other. Various surfaces can be made to have high frictional coefficients: the inner surface of the anchoring member, the bottom surface of the plate, the upper surface of the plate, and the bottom surface of the base of the bracket. Any and all of these may be manufactured with a textured surface. [0025] In methods that employ the embodiments with the plate, a user can anchor the frame onto a tooth; place the bracket base into the opening of the receiving member of the frame; and insert the plate into the cavity and underneath the bracket base to lock the bracket into position. The method further includes, after the frame is anchored to the tooth, to unlock the bracket by removing the plate and repositioning the bracket base. The user can then re-insert the plate into the cavity and underneath the bracket base to lock the bracket into a different position. [0026] Additionally disclosed are kits that have a frame and a bracket. The kits can have as frames and brackets, any of the embodiments disclosed herein. The kits can also include wires (e.g., archwires), ligating members, or other tools to facilitate the use of the bracket systems. Some embodiments of the kits instead include a frame with two or three side walls, and a plate that can be inserted to fasten the bracket system. The plate can be manufactured from the same materials as the other parts, such as the frame. For example, the plate can be made from nickel-titanium alloys, titanium-molybdenum alloys, and/or stainless steel. [0027] The present invention has several advantages. Because the frame can be manufactured as a single piece, production costs are lower, and also the potential of a piece being lost is lower. The simplicity of a single piece also facilitates the ease of using the bracket system. The combined locking action of the fasteners and the textured surfaces ensures that the bracket and the frame do not move relative to each other unless desired. The ability to rotate the bracket 360 degrees, and also the ability to move (e.g., translate) the bracket in any direction along the mentioned 360 degrees enables a clinician to achieve any desired orientation of the bracket to bring about a needed orthodontic adjustment of a tooth. The obviated need to remove the bond between a tooth and a bracket during treatment, because of the use of a frame separate from the bracket, facilitates faster treatment times and reduces any potential of damaging the tooth due to such unbonding-rebonding cycles. BRIEF DESCRIPTION OF THE DRAWINGS [0028] The foregoing and other objects, features, and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which parts are referred to by reference characters across views. The drawings are not necessarily to scale, emphasis instead being placed on illustrating the principles of the invention. [0029] FIG. 1 is a top view of a dynamic bracket system, where Ref. 1 is the bracket system frame, Ref. 2 is the moving cover, Ref. 3 is the stationary cover, Ref. 4 is the releasing notch, Ref. 5 is the bracket wire slot, Ref. 6 is a bracket slot component, Ref. 7 is the junction between the moving and stationary covers, and Ref. 8 is the opening to the bracket compartment [0030] FIG. 2 is a perspective view of a dynamic bracket system, where Ref. 1 is the bracket system frame, Ref. 6 is the bracket slot component, Ref. 9 is the tooth surface, Ref. 10 is the bracket base, Ref. 11 is the upper arm of the bracket slot component, Ref. 12 is the wire slot of the bracket slot component, Ref. 13 is the lower arm of the bracket slot component, Ref. 14 is the bracket stem, and Ref. 16 is the bracket slot compartment [0031] FIG. 3 is a top view of a bracket slot compartment opening created by joining of stationary and moving covers, where Ref. 1 is the bracket system frame, Ref. 2 is the moving cover, Ref. 3 is the stationary cover, Ref. 4 is the releasing notch, Ref. 7 is the junction between the moving and stationary covers, and Ref. 8 is the opening for the bracket slot compartment [0032] FIG. 4 is a top view of a bracket slot compartment without covers, where Ref. 1 is the bracket frame, Ref. 15 is the textured surface of the interior of the bracket slot compartment, Ref. 16 is the bracket compartment, and Ref. 17 is the guiding grooves within the interior of the frame [0033] FIG. 5 is a perspective view of a bracket slot compartment without covers, where Ref. 1 is the bracket frame, Ref. 15 is the textured surface of the interior of the bracket slot compartment, Ref. 16 is the bracket compartment, Ref. 17 is the guiding grooves within the interior of the frame, and Ref. 18 is a projection along the guiding groove [0034] FIG. 6 is a perspective view of a stationary cover and moving cover in an unlocked position, where Ref. 2 is the moving cover, Ref. 3 is the stationary cover, Ref. 4 is the releasing notch, Ref. 8 is the opening for the bracket slot compartment created by the joining of the moving and stationary covers, Ref. 19 is the securing depression on the moving cover, Ref. 20 is the securing depression on the stationary cover, Ref. 21 is the connecting edge of the moving cover, and Ref. 22 is the connecting edge of the stationary cover [0035] FIG. 7 is a close-up top view of covers in an unlocked position, where Ref. 2 is the moving cover, Ref. 3 is the stationary cover, Ref. 4 is the releasing notch, Ref. 8 is the opening for the bracket slot compartment created by the joining of the moving and stationary covers, Ref. 21 is the connecting edge of the moving cover, and Ref. 22 is the connecting edge of the stationary cover [0036] FIG. 8 is a perspective view of a bracket slot component, where Ref. 10 is the base of the bracket, Ref. 11 is upper arm of the bracket slot component, Ref. 12 is the slot of the bracket where the orthodontic wire is inserted, Ref. 13 is the lower arm of the bracket component, and Ref. 14 is the stem of the bracket [0037] FIG. 9 is a schematic of a perspective view of an embodiment of the bracket system. [0038] FIG. 10 is a schematic of perspective views of the embodiment of the bracket system of FIG. 9 , showing a bracket and a frame as separated components. [0039] FIG. 11 is a schematic of a side view of the embodiment of the bracket system of FIG. 9 . [0040] FIG. 12 is a schematic of a perspective view of an embodiment of the bracket system showing a bracket that is rotated differently relative the one shown in FIG. 9 . [0041] FIG. 13 is a schematic of a top view of an embodiment of the bracket system showing the relative alignments of different markings on a bracket with those on a frame. [0042] FIG. 14 is a schematic of a perspective view of an embodiment of the bracket system that is different than the one shown in FIG. 9 through FIG. 13 . This particular bracket system is shown with its bracket and frame as separated components. The figure also shows two screws that are used to fasten the frame once it receives the bracket. [0043] FIG. 15 is a schematic of a perspective view of an embodiment of the bracket system that shows the components of the system together. These components were shown in their separated states in FIG. 14 . [0044] FIG. 16 is a schematic of a perspective view of an embodiment of the bracket system. The figure shows the embodiment shown in FIG. 15 from its opposite side, essentially revealing the exterior surface of its frame that can contact a tooth. [0045] FIG. 17 is a schematic of a perspective view of an embodiment of the bracket system that is different than the one shown in FIG. 9 through FIG. 13 , and also different from the one shown in FIG. 14 through FIG. 16 . This particular embodiment uses a lever, as shown, to fasten the frame. The figure only shows the frame component; the bracket component has been removed to better illustrate different parts of the lever. [0046] FIG. 18 is a schematic of a side view of an embodiment of the bracket system, part of which is also shown in FIG. 17 . The bracket system in the figure is seen in an unlocked position due to the lever being in a raised position. [0047] FIG. 19 is a schematic of a perspective view of an embodiment of the bracket system, not shown in any of the previous figures. The bracket system is shown with its components separated from each other. The components include the frame, the bracket and the plate. [0048] FIG. 20 is a schematic of a side view of the embodiment of the bracket system shown in FIG. 19 , depicting a bracket placed on top of a plate residing within a cavity of the frame. [0049] FIG. 21 is a schematic of a top view of the embodiment of the bracket system shown in FIG. 19 , depicting a plate inserted into the frame with the grip end of the plate sitting outside of the frame. DETAILED DESCRIPTION OF THE INVENTION [0050] A description of preferred embodiments of the invention follows. [0051] FIG. 1 is a top view of an embodiment of the dynamic bracket system. The shown dynamic bracket system is composed of a bracket system frame ( 1 ) which is connected to the tooth surface ( 9 ) (not shown in FIG. 1 but shown in FIG. 2 ). The interior of the shown frame has grooves or guiding lines ( 17 ) for the insertion of the stationary cover and moving cover. See FIG. 4 . The moving cover ( 2 ) is inserted after the stationary cover ( 3 ) into the frame such that the covers connect at a junction ( 7 ). The connected covers exert a vertical pressure on the bracket base ( 10 ) that helps secure the base inside the bracket compartment ( 16 ). The moving cover ( 2 ) has a releasing notch ( 4 ) into which an orthodontic plier or tool can be inserted in order to release the moving cover from the frame ( 1 ). Once the stationary cover ( 3 ) is in place within the frame, the bracket slot component ( 6 ) is inserted followed by another bracket slot component ( 6 ). Each bracket slot component, in this embodiment, has a bracket wire slot ( 5 ) for the insertion of a guiding wire into the bracket system. The interior edges of both the stationary cover and the moving cover contain a cutout section such that an opening to the bracket compartment ( 8 ) is created where the bracket slot component ( 6 ) will be inserted within the bracket system. [0052] FIG. 2 is a perspective view of the dynamic bracket system that was shown in FIG. 1 . The bracket system can be attached to the front surface of the user's tooth ( 9 ). The bracket slot component ( 6 ) is composed of an upper arm ( 11 ), a wire slot ( 12 ), a lower arm ( 13 ), a stem ( 14 ) and a base ( 10 ). The bracket slot component ( 6 ), in this embodiment, is inserted into the frame ( 1 ) between the stationary cover and moving cover. The bracket base ( 10 ) of the bracket slot component rests beneath the stationary and moving covers in the bracket slot compartment ( 16 ), where the bracket base is secured by vertical pressure from the covers. The interior surface of the bracket slot compartment, in this embodiment, is textured ( 15 ) to prevent movement of the bracket slot component ( 6 ). The bracket stem ( 14 ) is inside the opening ( 8 ) for the bracket slot compartment ( 16 ). The opening ( 8 ) is created, in this embodiment, by the joining of the edges of the stationary cover and moving cover. See FIG. 3 . Each cover has an irregularly shaped interior edge, which creates an opening to the compartment ( 8 ) to allow for the insertion of the bracket stem between the joined covers. [0053] FIG. 3 is a top view of the bracket slot compartment opening created by the joining of the stationary and moving covers, corresponding to parts of the embodiment shown in FIG. 1 and FIG. 2 . The stationary and moving covers each contain an irregularly shaped interior edge that creates an opening ( 8 ) for the bracket slot compartment when the covers are aligned. The stationary cover ( 3 ) is inserted into the bracket system frame ( 1 ) along the guiding grooves ( 17 ). Then the moving cover ( 2 ) is also inserted along the guiding grooves ( 17 ) until its sloped edge meets the sloped edge of the stationary cover ( 3 ) at the junction point ( 7 ). The outer edge of the moving cover ( 4 ) has a releasing notch ( 4 ) that assists in the removal of the moving cover. Pressure applied to the releasing notch with a dental tool will release the moving cover from its position. The dental tool can be any type of the following: cutter, explorer, plier, stripper, or scaler. The opening ( 8 ) to the bracket slot component is created by the joining of the stationary and moving covers at their interior edges. [0054] FIG. 4 is a top view of the bracket slot compartment ( 16 ) without the stationary cover or moving cover. The embodiment shown in this figure, and described in this paragraph, corresponds to the ones shown in FIG. 1 , FIG. 2 , and FIG. 3 . The components of the bracket system are assembled within the bracket frame ( 1 ). The interior edges of the frame, in this embodiment, have guiding grooves ( 17 ) that the stationary and moving covers glide along as the covers are inserted into the frame. The interior surface of the bracket compartment is textured ( 15 ) to prevent movement of the bracket base ( 10 ) within the compartment ( 16 ). [0055] FIG. 5 is a perspective view of the bracket slot compartment ( 16 ) without the stationary cover or moving cover. The embodiment shown in this figure, and described in this paragraph, corresponds to the one shown in FIG. 1 through FIG. 4 . The components of the bracket system are assembled within the bracket frame ( 1 ). The interior edges of the frame ( 1 ) have guiding grooves ( 17 ) that the stationary and moving covers glide along as the covers are inserted into the frame ( 1 ). There are a number of projections ( 18 ), along the surface of the guiding grooves ( 17 ) that lock with the depressions ( 19 ) on the moving and stationary covers to secure the covers to the frame ( 1 ). The connection between the projections ( 18 ) and the depressions ( 19 ) also exerts vertical pressure on the bracket base ( 10 ) within the bracket compartment ( 16 ). The interior surface of the bracket compartment ( 16 ) is textured ( 15 ) to prevent movement of the bracket base within the compartment ( 16 ). [0056] FIG. 6 is a perspective view of the stationary cover and moving cover in an unlocked position. The moving cover ( 2 ) and the stationary cover ( 3 ) both have connecting edges ( 21 , 22 ) that lock together at the junction. In addition, the moving cover ( 2 ) and the stationary cover ( 3 ) both have cutout sections on the interior edges of the covers. When the moving cover and the stationary cover are locked or joined, a closed off round opening ( 8 ) is created. The bracket component can be positioned within this opening ( 8 ) to the bracket slot compartment ( 16 ) when the bracket system is fully assembled. The moving cover has dual securing depressions ( 19 ) at its exterior edges that serve to secure the moving cover ( 2 ) and prevent the cover from falling out of the frame ( 1 ). These depressions ( 19 ) connect with projections ( 18 ) along the guiding groove ( 17 ) to secure the cover in the frame. The stationary cover also has dual securing depressions ( 20 ) at its outer edges that serve to secure the stationary cover ( 3 ) and prevent the cover from falling out of the frame. The securing depressions on the bottom side of the covers protrude and prevent the covers from sliding out of position. These depressions ( 20 ) connect with projections ( 18 ) along the guiding groove ( 17 ) to secure the cover in the frame ( 1 ). There is also a releasing notch ( 4 ) that unlocks the cover once an orthodontic plier is inserted in the latch with sufficient force from a hand or a dental tool. [0057] FIG. 7 is a close-up top view of the covers in an unlocked position. The moving cover ( 2 ) and the stationary cover ( 3 ) both have connecting edges ( 21 , 22 ) that lock together at the junction and cutout sections on the interior edges of both covers. When the moving cover and the stationary cover are locked or joined, a closed off round opening ( 8 ) is created. The moving cover has dual depressions ( 19 ) at its outer edges that serve to secure the moving cover and prevent the cover from falling out of the frame. The stationary cover also has dual securing depressions ( 20 ) at its outer edges that serve to secure the stationary cover ( 3 ) and prevent the cover from falling out of the frame. There is also a releasing notch ( 4 ) that unlocks the cover once an orthodontic plier is inserted in the latch with sufficient force from a hand or a dental tool. [0058] FIG. 8 is a side view of a bracket component. The shown bracket slot component is made of an upper arm ( 11 ) and a lower arm ( 13 ) with a slot ( 12 ) between the arms wherein an orthodontic wire would be inserted to aid in the movement of teeth. Two bracket slot components would collectively have two upper arms, two lower arms, and a slot that would run along both of the individual slots. Beneath the slot ( 13 ), lies the stem ( 14 ) of the bracket slot component. The stem is of a smaller diameter than the distance between the outside edges of the upper and lower arms of the bracket component. Beneath the stem, lies the base of the bracket ( 10 ) which is of a length larger than that of the stem. The stem ( 14 ) of the bracket slot component is inserted through the bracket compartment opening ( 8 ) and the base ( 10 ) of the bracket slot component rests against the textured interior surface ( 15 ) of the bracket compartment in the bracket frame ( 1 ). [0059] The embodiments described herein can be used to create mesial movements (toward the central teeth), distal movements (toward the last molars), lingual movements (toward the tongue behind the teeth), facial movements (toward the lips (labial) or toward the cheeks (buccal)), apical movements (toward the root), coronal movements (toward the crown), or any combination thereof. Certain embodiments are especially suited for mesial, distal, lingual, and facial movements. Other terms for the types of movements that can be created include tipping, torqueing, translation, root uprighting, rotation, extrusion, and intrusion. Tipping refers to a type of mesiodistal movement, and torqueing is a buccolingual movement. Extrusion is a coronal, and intrusion an apical movement. Forces required for these types of movements can be in the 15 to 150 g range or higher, and are attainable with the embodiments disclosed herein. The units used herein for forces are grams, abbreviated as “g”. Even though gram, from a physical standpoint is a unit for mass, in orthodontics, it is sometimes used as a shorthand for gram-force, and is understood to stand for the amount of force the standard gravity (e.g., 9.8 m/s 2 ) would exert on an object having a certain mass. By this definition used herein, 1 g would be equivalent to a force of approximately 0.0098 N (Newton), while 1N would approximately equal 101.97 g. In some publications, it is possible to come across different definitions of some of the terms relating to the movements of teeth. For example, tipping is sometimes referred to as the simplest orthodontic movement that occurs at about the center of resistance of a tooth (sometimes described as ⅓ from root apex or 40% of root length from alveolar crest). For such a tipping, forces are high at apex and alveolar crest, for example 35-70 g, while they reduce to zero at center. Such a broad definition (not used herein) would combine the definitions of tipping (as used herein) and torqueing (as used herein) into one general term. Translation can be referred to as any bodily movement where all of periodontal ligament is uniformly loaded with forces such as 70-150 g. Rotation is sometimes believed to need a level of force that is theoretically high, and because of the ensuing compression of the periodontal ligament with forces around 35-100 g, tipping may accompany an attempted rotation. Extrusion, as a vertical movement, depends on creating tension at the fibers of periodontal ligament, of around 35-60 g. Intrusion, a similarly vertical movement, has forces of 10-25 g concentrated at root apex. Forces used to bring different tooth movements about can be applied continuously (at a light level, sometimes referred to as “ideal”) or only when wearing an appliance (sometimes referred to as “interrupted”). As a hybrid of the two types above, the force can also be applied such that it gradually reduces (e.g., to zero) between visits to a clinician (this type of force is sometimes referred to as “intermittent”). The appliances used to apply forces can be, in general, fixed or removable. Each of the embodiments of the present invention can be used to effectuate the rotation/positioning described above without having to re-bond the frame to the tooth. Once the frame is anchored to the tooth, this can be accomplished by unlocking the bracket, repositioning it, and re-locking the bracket into place. [0060] From a purely physical standpoint, orthodontic tooth movements can be described as either translations, rotations, or a combination of the two. In some texts, it is possible to come across the term “tipping” to be used in the sense of a “combination” as described above (e.g., broadly as a combination of translation and rotation). A force that does not pass though the center of resistance of a tooth can cause the combination of translation and rotation, essentially resulting in movement with some rotational element. To create pure rotation, a single force is not enough; at least a couple (e.g., two forces) are needed. [0061] Periodontal ligament (PDL) attaches a tooth to the alveolar bone and has fibroblasts, osteoblasts, osteoclasts, and undifferentiated cells, among others. PDL is at the interface between the tooth and the cortical bone. Cortical bone has slow turnover, whereas trabecular bone that is adjacent but further away from the tooth, has constant turnover. When force is applied to a tooth, PDL/bone receives the force and this leads to microfractures, in addition to other changes. Ultimately, osteoblasts mediate tension and osteoclasts mediate compression; hence, deposition (secretion of new bone by osteoblasts) and resorption (breaking down, by osteoclasts) of bone is accomplished. Level and duration of force are important for properly moving the teeth. For describing movements of the teeth, it is often useful to refer to the six different surfaces of a tooth. These surfaces are: gingival, occlusal, lingual, labial, mesial, and distal surfaces. [0062] As mentioned, when a tooth moves, osteoblasts facilitate formation of new bone (e.g., bone deposition) from a location that a tooth has moved from, and osteoclasts facilitate removal (e.g., bone resorption) of bone tissue from the area that a tooth is moving into. The embodiments described herein can be used with a suitable pace of bracket adjustments so that bone formation and degradation are optimal, as determined by a clinician. In some embodiments, the used brackets can be made from translucent ceramic so that they are less visible against natural teeth. The brackets can be used with any wires, including nitinol (Nickel-Titanium alloy) wires with shape memory effects at various temperatures. Other materials for the wires include Titanium-Molybdenum alloys and stainless steel. The frames can be bonded to the teeth via bonding materials as well as via metal bands. [0063] Brackets, wires, and other orthodontic supplies can be purchased from a variety of sources such as JesOrthopental, Fort Lauderdale, Fla.; Henry Schein Dental, Waltham, Mass.; and 3M Unitek Orthodontic Products, Monrovia, Calif. [0064] One physical phenomenon on which some of the wires (e.g., archwires) used in contemporary bracket systems operate is shape memory effect, which allows application of appropriate forces to move the desired teeth. Some materials have the ability to return to a shape upon being exposed to a certain inducer, such as a change in temperature. Two common examples of such materials, sometimes called smart materials, are shape memory alloys (SMA) and shape memory polymers (SMP). SMAs can be set to a certain shape by being forged at a low temperature, and they will remember and try to return to that shape when they are placed at a higher temperature. For example, the desired shape can be set at a temperature that is much lower than the body's temperature, and the material, after being placed in or near a human body, would remember its original temperature and would try to return to it, in effect generating forces toward that original shape. These materials with shape memory can be used in the making of archwires for dental braces. The set and the post-heating states are sometimes described as the martensitic and the austenitic states, respectively. Common alloys used to make SMAs include nickel-titanium and copper-aluminum-nickel alloys. While the most common SMAs remember their shape at a low temperature and try to return to it from a high temperature state, some SMAs can remember both a low and a high temperature state. The ability to create SMAs with varying materials and compositions of such materials allows the manufacturing of alloys of a wide variety of size and shape. While SMAs have been commonly employed for dental braces, SMPs may constitute a reasonable alternative in the future as well. SMPs can be induced to undergo transitions between states by changes in temperature, light, and fields such as electrical or magnetic ones. Some SMPs are also known to be able to remember three states, instead of only two (e.g., some can switch from a first state to a second one upon being subjected to a first inducer, and from the second one to a third one upon being subjected to a second inducer). Wires based on such elastic properties can be useful especially during the initial stages of treatment. [0065] By frictional coefficient, it is referred to the ratio of a force opposing movement due to friction to a force pressing the objects toward each other. Sometimes also referred to as the coefficient of friction, the frictional coefficient is a measure of the friction, or of the force resisting the relative motion of two objects. For example, if the inner surface of the anchoring member of the frame and also the bottom surface of the bracket are made smooth, they would have a lower frictional coefficient compared to the case in which both are made with textured surfaces. The same can be said of the frictional coefficient between the external surface of the anchoring member of the frame and the surface of a tooth. By a high frictional coefficient, it is referred to a frictional coefficient that is high enough to prevent relative movements of the two objects (e.g., the bracket and the frame). By preventing the relative movements, what is meant is that the two objects would not move relative to each other more than a certain percentage of their average length during a certain period of time (e.g., 1%, 2%, 3%, 4%, 5%, or 10% within 1 day, 1 month, or 1 month). In the field, with respect to archwires and brackets, it is commonly believed that stainless steel can slide relatively well on stainless steel, whereas nickel-titanium alloy wires and ceramic brackets have higher frictional coefficients. [0066] With the term single-piece, it is referred to an object (e.g., frame) that is not easily separated into components in a reversible way. Such an object may be made from substantially the same material throughout, or can be made from a mixture of materials. An object made of multiple objects welded together is also considered to be a single-piece object. [0067] In some embodiments, self-ligating brackets can be used, in addition to more traditional brackets. Arch wires can be maxillary or mandibular, and they can be made of NiTi, TMA, or stainless steel. The wires can be parabolic shaped or shaped in any other way as desired. The wires can be straight wires, as opposed to requiring to be bent by a clinician. Retainers may need to be worn after the dental braces are removed. The brackets used can be modified to make them self-ligating brackets. Additional usable components include bands, molar tubes, brackets, buccal tubes, arch wires, and auxiliaries. Auxiliaries can include elastomeric products, coil springs, lingual arches, and extra-oral appliances. [0068] The bracket system described herein can be positioned on the labial or buccal side (collectively, the facial side) of a tooth. In alternative embodiments, the bracket system can also be positioned on the lingual side. [0069] In some embodiments, the terms “bracket” instead of “bracket slot component”, “neck” instead of “stem”, “interior surface” instead of “textured surface of interior”, “arm A/B/C/D” instead of “lower/upper arm”, and “groove” instead of “bracket compartment” are used. In alternative embodiments, the term “fastener” and “plate” may be used interchangeably. In those embodiments, although strictly inaccurate, the term “hinge” may be used to point to a “side wall”. Referring to FIG. 9 , another embodiment of the bracket system is shown. [0070] Bracket system 190 A is shown in a perspective view with two of its parts: bracket 170 and frame 180 A. Bracket 170 has arm 154 A, arm 154 B, arm 154 C, and arm 154 D. These arms are arranged in such a way that the spaces between them create one or more slots. In the figure, the space created by arms 154 A and 154 B on one side, and arms 154 C and 154 D on the other side is first slot 156 . In some embodiments, a wire (e.g., an archwire) can be placed (e.g., inserted, threaded, positioned) into this first slot. Second slot 158 is formed by the arms 154 B and 154 C on one side and the arms 154 A and 154 D on the other side. In some embodiments, this second slot can also be used to place a wire. Also shown as part of bracket 170 in this figure are the extensions. Extension 164 B is seen as a wing of arm 154 B, extension 164 C as a wing of arm 154 C, and extension 164 D as a wing of arm 154 D. Extension 164 A is the wing of arm 154 A. These extensions are overhangs that can allow placement of a ligating member (such as a ligating module, which can be a donut shaped plastic piece that ties in an archwire to the bracket). Other than the bracket, in FIG. 9 , the frame is shown. Frame 180 A is seen to have receiving member 114 A, anchoring member 112 A, and clip 124 A. Anchoring member is the part of the frame that is closest to the tooth surface, and the receiving member is the part that is closer to the bracket arms. The clip materially is not a separate piece in this embodiment, and is seen to be an extension of the anchoring member. Because the clip constitutes the fastener, and because the fastener is integral to the frame, in this embodiment, frame 180 A and frame member 110 A are not practically distinct. In other embodiments, it will become clear that when fastener includes additional items (such as screws), the frame member is mostly comprised by anchoring and receiving members, whereas the frame is comprised by not only the anchoring and receiving members, but also by the fastener (e.g., a screw). [0071] The fastener shown in FIG. 9 is seen to have clip teeth 124 B that lock against receiving teeth 124 C of the receiving member. Clip 124 A is also seen to have stopper 124 D and clip opening 124 E. The stopper ensures that even if the clip teeth lose their grip, the receiving member will not be substantially removed from the anchoring member. The clip opening is an optional feature, and in some embodiments can be eliminated. [0072] Also seen in FIG. 9 are hinge 116 A and groove 130 A. The hinge connects the receiving and the anchoring members and allows relative movements of the two in order to accommodate insertion and removal of a bracket. The hinge can be manufactured from the same materials as the rest of the frame, and need not be a separate piece. In certain embodiments, the hinge can be a separate piece. Groove 130 A is the compartment between the receiving and the anchoring members within which the base of the bracket is accommodated. Even though shown as open through the entire length of the area of the receiving member, the groove can be blocked from the sides in some embodiments. For example, either the receiving member or the anchoring member, or both can have an extension on the side that when the two members are closed onto each other, essentially closes one or more sides of the groove. [0073] The term “closed” or “closing” in the context of the two members, the receiving and the anchoring members, is used to refer to the relative state of the two members when the receiving member cannot easily receive a bracket. As should be apparent, the two members need to be, at least slightly, pried open so that a bracket can be inserted without significant friction. Such a state, in which a bracket can be inserted and removed without significant friction, is referred to as the “open” state of the frame. On the other hand, the terms “lock”, “locked”, etc. are used to relate to the state of the receiving members and anchoring members when they are secured to prevent accidental or unwanted movement of the bracket. In certain embodiments in which the receiving members and anchoring members do not move, the term “locked” refers to the bracket being secured and does not move accidentally or unwantedly. In such an embodiment in which the receiving members and anchoring members are stationary, the term “unlocked” refers to the bracket's ability to move within the frame without significant friction. The terms “unlock”, “unlocked”, etc. relate to the state of bracket's ability to move relative to the frame. When the bracket is locked within the frame, a patient cannot simply pull and remove a bracket from the frame while leaving all the parts intact. [0074] In particular embodiments that have a plate, a distinction between open and closed states need not be made, since the anchoring and receiving members are relatively fixed with respect to each other. In those embodiments, the bracket system can be locked by use of a plate, and unlocked by the movement and/or removal of the plate. [0075] Now referring to FIG. 10 , the left side shows bracket 170 and the right side shows frame 180 A. As shown in this side view, bracket 170 has base 150 and neck 152 , in addition to having the arms and extensions mentioned during the discussion of FIG. 9 . First slot 156 is clearly visible between arm 154 B and arm 154 C. A wire can be placed into that slot and then stabilized via a variety of methods (e.g., ligating modules that make use of the extensions, or additional covers that go above the slot). Neck 152 , referred to as a stem in some other embodiments, connects the base of the bracket with the arms of the bracket. The neck can be substantially surrounded by the receiving member once the bracket is in place within a frame. Base 150 , once a bracket is placed into the groove (also called compartment in other embodiments) of a frame, rests against the inner surface of the anchoring member. In some embodiments, either one or both of the inner surface of the anchoring member and the bottom surface of the base are manufactured as a textured surface in order to increase the friction when they come together. This aids in stabilizing the relative positions of the two. [0076] On the right side of FIG. 10 , frame 180 A is shown with opening 118 A, neck opening 120 A, interior surface 126 A, lobe 122 A, lobe 122 B, and lobe 122 C. Opening 118 A is where the bracket will be rested once in place. Within the opening, the bracket has freedom to move, provided that the frame is in an unlocked position. The neck opening is designed to allow insertion of the bracket into the frame. Upon prying apart at either the clip or the receiving member, depending on the embodiment used, a bracket can be slid through neck opening 120 A and positioned within opening 118 A. Interior surface 126 A can be textured to increase the frictional grip it has on the bracket. The lobes can be arranged in any way, and there can be fewer or more than three lobes. In an embodiment, the lobes confer an enhanced degree of movement to the bracket. For example, in the figure shown, the bracket can be positioned along any of the four directions: toward lobe 122 A, toward lobe 122 B, toward lobe 122 C, or toward neck opening 120 A. Also, the bracket can be rotated clockwise or counterclockwise within the opening. The ability to move in these various directions is useful because by placing a bracket in a different location with respect to the tooth, a different force can be exerted onto the tooth, effectively moving it in a different way. [0077] Turning our attention to FIG. 11 , bracket system 190 A is shown from a side view. This view clearly shows the interlocking clip teeth 124 B and receiving teeth 124 C. Stopper 124 D is also shown to stop any potential movement beyond a certain level, in case the clip teeth or the receiving teeth suffer a trauma and are unable to lock the frame. Base 150 of the bracket is seen to be placed into groove 130 A of the frame. In this figure, the first slot, which can accept a wire, is seen to be in a direction parallel to that of the clip. This is not mandatory, as will become clear with inspection of the next figure. [0078] FIG. 12 shows bracket system 190 A from a perspective view, this time with bracket 170 rotated to a different degree than the one shown in FIG. 9 . From this drawing, it should be apparent that the bracket can be rotated to any degree (e.g., 0 to 360 degrees). In any of these rotated orientations, any of the slots (first slot 156 or second slot 158 ) can be used to accommodate an archwire. In addition to rotating the bracket around a range of 360 degrees, the bracket can also be moved (translated) toward any of the 360 degrees. Even though the highest level of movement will be allowed in the directions corresponding to those of the lobes, some movement toward other directions can also be permitted in certain embodiments. A range of rotations and movements is possible with bracket being able to move within the lobes and rotate the within frame. [0079] FIG. 13 shows a top view of bracket system 190 A, which shows one embodiment having markings on the bracket and the frame to assist the dental practitioner in aligning the bracket. Any embodiment described herein can use such a bracket with the markings for alignment. In this figure, the relative alignment is achieved with the coarse orthogonal markings, fine orthogonal markings, and oblique markings of the frame with the orthogonal bracket markings and oblique bracket markings. Coarse orthogonal markings 132 A through 132 K are in a perpendicular direction to an edge of the receiving member (marks 132 I and 132 K are not visible in the figure). Fine orthogonal markings 134 A through 134 L are also in a perpendicular direction to an edge of the receiving member, but are shorter than the coarse orthogonal markings (marks 134 J and 1343 K are not visible in the figure). Such an arrangement can be used, for example by first aligning the bracket against the coarse markings and then against the fine ones to increase the precision. In addition to these orthogonal markings, the receiving member is also shown to have oblique markings 136 A through 136 D. Any of these markings can be of use during both the rotational and translational movements of the bracket with respect to the receiving member. To make it easier to register the bracket against these markings, the bracket itself can have markings. The figure shows bracket 170 to have orthogonal bracket markings 160 A through 160 D and oblique bracket markings 162 A through 162 D. A clinician can record and keep track of the relative alignments of these against each other throughout the duration of a treatment. That way, an accurate history of the progress of the forces applied on a tooth will be available, which can be used to further increase the precision of the orthodontic treatment. [0080] Referring now to FIG. 14 , an additional embodiment of the bracket system is displayed in a perspective view, with its components shown separately. Bracket system 190 B is shown with bracket 170 , frame 180 B, first screw 124 F, and second screw 124 G. In this embodiment, instead of the clip that was used in the embodiments shown in figures FIG. 9 through FIG. 13 , screws and screw receivers are used. A screw receiver is a hole having a complementary thread to the helical ridge of a screw. Screws, depending on their design, can be tightened by clockwise or counterclockwise rotation, and then untightened by an opposite rotation. The combination of screw 124 F, screw 124 G, and frame member 110 B constitutes frame 180 B. Screw 124 F is initially received by first screw receiver 124 H, which can have a complementary interior surface to snugly receive first screw 124 F. Similarly, second screw 124 G is initially received by second screw receiver 124 I. To achieve the locking of the frame, each screw is ultimately received by an additional screw receiver. First screw 124 F is received by third screw receiver 124 J, and second screw 124 G is received by fourth screw receiver 124 K (shown in FIG. 16 ). The third and fourth screw receivers do not need to extend along the full width of the anchoring member, although they can if the screws are manufactured with a limited length so that they will not protrude from the anchoring side toward the tooth. In some embodiments, only the third and fourth screw receivers have spirally accommodating grooves for the screws, and the first and second receivers are merely holes through which the screws can pass. [0081] FIG. 14 also shows parts that are analogous to those shown in prior embodiments. Examples of parts shown are lobes 122 D through 122 F, groove 130 B, anchoring member 112 B, receiving member 114 B, frame member 110 B, opening 118 B, neck opening 120 B, and bracket 170 with similar parts. Unlike the previous embodiment shown, this one has two hinges: hinge 116 B and hinge 116 C. In some embodiments, there can be fewer or more hinges. Similarly, in alternative embodiments, there can be fewer or more screws and screw receivers. Screws can be placed anywhere along the frame, as long as they stabilize, or do not prevent stabilization of a bracket. This figure intuitively illustrates how a bracket can be inserted onto a frame though the neck opening of the frame and the how the frame can be locked to stabilize the bracket. [0082] Directing our attention to FIG. 15 , bracket system 190 B is shown with the bracket 170 and frame 180 B, as they fit together. Screw 124 G is seen to extend along groove 130 B all the way to the fourth screw receiver. First slot 156 formed between arms 154 A with 154 B on one side and 154 C with 154 D on the other side is shown to be perpendicular to the direction from one screw to the other. Similar to other embodiments, another slot can be used, as well as the first slot, to place a wire. Again similarly, the bracket can be rotated or translated, or rotated and translated in any direction that is within a plane parallel to the plane of the receiving member. [0083] Referring to FIG. 16 , bracket system 190 B is shown in a perspective view that makes apparent the exterior surface of the frame that contacts a tooth. This view is upside-down compared to the one in FIG. 15 . Exterior surface 128 B is shown to have a series of circular depressions. A variety of texture features can be used on the exterior surface on any of the embodiments described herein. In addition to depressions, projections, recesses, general roughness, and any regular or irregular features, pure or together with other kinds of features can be used, as long as the final exterior surface has a better frictional interaction, to any degree, with a tooth surface than an exterior surface with no features. In an embodiment of using the bracket system, a clinician leaves the frame on the tooth for the entire duration of the treatment, which can last up to years, and only adjusts the bracket during certain intervals. Because the frame only will need to be removed once, at the end of the treatment, the bonding between a tooth and the exterior surface can be strong. [0084] Now looking at FIG. 17 , the frame part of a yet another embodiment of the bracket system is shown. In parallel with the previously discussed embodiments, the frame is stabilized by a fastener; however, in contrast to the previous embodiments, the fastener is a lever and not a screw or a clip, in the sense of the previous embodiments. Frame 180 C is shown having lever 124 L. Lever 124 L is attached to the frame at first lever support 124 P and at second lever support 124 Q. The lever, shown overall to have a shape of an irregular tube herein, is threaded in this embodiment through first lever receiver 124 R and second lever receiver 124 S. First lever receiver 124 R is a hole within first lever support 124 P, and second lever receiver 124 S is a hole within second lever support 124 Q. Lever 124 L can rotate through the two lever receivers such that it can reach near the hinge from the receiving member side as shown. The depicted embodiment is a locked position of the frame. Locking action is accomplished by lever lock 124 N, which is the part of the lever that applies pressure on the side of the receiving member that is near neck opening 120 C. As seen, lever lock is a segment of the lever that longitudinally protrudes away from the lever in such a way that when the lever is closed toward hinge 116 D, the lever lock presses onto the receiving member. Also shown in this figure are lobes 122 G though 122 I, groove 130 C, frame member 110 C, anchoring member 112 C, receiving member 114 C, and opening 118 C. The part of the handle that can be moved, manually or with a tool, is designated as lever handle 124 M. Lever handle can be the entire accessible length of the lever other than the lever lock, or it can be just the part of the lever that extends along the hinge when closed, depending on the embodiment. [0085] FIG. 18 shows bracket system 190 C with lever 124 L in a position that displays frame 180 C in an unlocked position. As seen, in contrast to FIG. 17 , when the lever is lifted away from hinge 116 D, receiving member 112 C is free to move away from anchoring member 114 C, effectively freeing bracket 170 to move or rotate within the opening. A clinician can lift lever handle 124 M, adjust bracket 170 , and then lock the lever handle by closing it toward hinge 116 D. Even though the figure shows first slot 156 to be positioned in the direction along the hinge, as should be apparent from the ability of the bracket to translate or rotate in any direction, the first slot can be aligned in any direction. In some embodiments, the second slot can be used as well, either to thread a wire through or to stabilize a wire threaded through the first slot. Locking can be effected by motions of the lever to positions other than the one shown in the figures as well. [0086] Presenting a different embodiment, FIG. 19 shows a bracket system in which the anchoring member and the receiving member are connected to each other via three sides (e.g., stationary sides). In alternative embodiments, the two members may also be connected through a number of sides different than three, for example they can be connected through two sides. Anchoring member 112 F is connected via sides 116 F, 116 G, and 116 H (not all shown) to receiving member 114 F. In this embodiment, the sides, the receiving member, and the anchoring member are constructed as a single piece. The anchoring member, the receiving member and the sides define a cavity in which, when in use, the bracket base and at least a portion of the plate reside. The height between the two members is relatively constant. Also shown in this figure is bracket 170 F, which can be substantially the same as the previous brackets shown (such as bracket 170 ). In contrast to the previous embodiments, in which the fastening of the system was achieved by the use of an external fastener, in this embodiment the fastener is essentially a plate. Plate 210 can be slid into the cavity and underneath the bracket, in which case it rests above the inner surface of the anchoring member of the frame and below the bottom surface of the bracket base. As such, the plate fixes the bracket system in place. In an embodiment, the plate has a sloping or tapered thickness. The plate has an insertion end and a grip end. The insertion end is the end that is inserted into the cavity and the grip end is the end that a user grips with fingers or plyers to perform the insertion. In the case of the embodiment shown in FIG. 19 , the insertion end is the end having the spring members/wings and the grip end is the end with the two openings for receiving a plyer. For example, the thickness at the grip end is greater than that at the insertion end. As the plate is inserted, the thickness of the plate at a point along the length of the plate meets the space between the bracket base and the interior surface of the anchoring member. When the plate hits that point, the bracket is locked in position within the frame. Put another way, the plate has a plurality of thicknesses along the length of the plate that gradually tapers from the grip end to the insertion end. At a point along the length of the plate, the thickness is equal to the space between the bracket base and the anchoring member. Yet said another way, the thickness at a point along the length of the plate plus the height of the bracket base is equal to the space of the cavity. [0087] For ease of insertion and removal, the plate can have one or more grips. In the figure shown, there are two holes, grips 212 A and 212 B, which enable a dental practitioner to remove the plate from the bracket system using a dental hand tool such as players. In other embodiments, there can be another number of grips (e.g., 1, 2, 3, 4, 5). The grips need not be holes, as long as they enable displacement (e.g., removal) of the plate they are sufficient for their purpose. For example, the grips can be an indentation or groove. In addition to the grips, the plate has spring 214 . Spring 214 has to spring members that, under pressure, will compress. When not under pressure, the spring members will return to their original shape/position. The spring is not essential for the functioning of the plate; however, in some embodiments it helps secure the bracket system in place. During insertion the pressure can be applied and the spring members can collapse a bit to allow for ease of insertion. When in a locked position (e.g., when plate is inserted under the bracket base to prevent unwanted movement of the bracket), in an embodiment, the spring members apply force to the frame and the bracket base to keep them in place. For use, in one method, the bracket is inserted into the frame through neck opening 120 F, and placed so that neck 152 F passes through receiving member opening 118 F, which is between lobes 122 J, 122 K, and 122 L. After that, plate 210 is inserted to the space underneath base 150 F and above interior surface 126 F. Each of the components can be reused, and need not be a disposable single-use part. In some embodiments, the plate has a sloped surface, and has a varying thickness along its length, which in turn causes the pressure to increase while it is being inserted, so that the plate cannot go further than a certain distance and so that at some point, optimal pressure is achieved. [0088] FIG. 20 shows the same embodiment introduced in FIG. 19 , with the three components of the bracket system shown together. In this side view, the plate has been inserted into the cavity and the bracket is firmly in place within the frame. Therefore, the bracket system in a locked position. A dentist or other dental practitioner can remove the plate by engaging plyers with the grip, thereby setting the bracket system in an unlocked position. Accordingly, the dental practitioner can adjust the position of the bracket and re-insert the plate and lock the bracket into a different position that the initial position of the bracket. The plate, the bracket, and the frame can be used repeatedly and the bracket can be re-positioned a multitude of times. [0089] FIG. 21 also depicts the embodiment of the bracket system shown in FIG. 19 , in which the plate is inserted but the grip end remains outside the frame. Since the grip end remains outside the frame, a clinician can engage the grip end to remove the plate. The plate being “removed” or “inserted” refer to differing degrees of removal/insertion. For example, as described above, depending on to what degree the plate is in or out, that the bracket is in a locked position or is in an unlocked position. Especially for embodiments in which the plate has a varying thickness (e.g., has a sloped upper surface), the bracket system can be effectively locked with a partial insertion of the plate. The grips, which can be openings or mere indentations, allow removal of the plate. In some embodiments, there is only one grip. [0090] Overall, the embodiment shown in FIGS. 19 , 20 , and 21 provides increased manufacturability and stability. Because the frame is enclosed, it holds everything in place and prevents potential breakages of parts, since the frame can be manufactured as a single piece. [0091] The described embodiments can be used to move a tooth in a variety of directions, as described. Additional components can be added to the bracket system. For example, metallic ligatures, elastic ligatures, or a self-ligating system component can be used to ensure stabilization of a wire. Other related components that can be used are bands, molar tubes, elastomeric products, coil springs, lingual arches, extra-oral appliances, and retainers. In some embodiments, the bracket component of the bracket system can have a base that is so slanted to result in the slot being angled in different ways relative to the surface of the tooth, and positioned in different ways relative to the center of resistance of the tooth. Alternatively, the arms and the surface of the neck that is away from the base can be manufactured in ways that would result in a desired slanting. The neck and the arms can also be manufactured in ways that can increase or decrease the distance between the base of the bracket and the area accessible to a wire within the slot. That would effectively result in movements of the bracket toward or away from a surface of a tooth. It is also possible to use an external item to be placed between the bracket and the frame, so as to obtain alternative arrangements of the bracket system. In some embodiments, the bracket can have a single slot, whereas, in others, in can have more than two slots. The bracket, in certain embodiments, can have fewer than four or more than four arms. [0092] In alternative embodiments, the bracket system can include at least two components: a frame and a slot component/bracket. In some embodiments, the bracket system has at least three components: a frame, bracket, and a plate. On one side (e.g., the exterior side), the frame can be bonded to the tooth surface with the use of an adhesive material commonly used in orthodontics. The frame can have a shape that bends on itself and creates a compartment (e.g., groove) in which the slot component (e.g., bracket) can move. The bracket slot component can include a stem (e.g., neck), a base, and a top portion where the slot and other components of a normal bracket lie. The stem can be positioned immediately below the top portion of the bracket and can be accommodated in the opening of the frame. The base of the bracket component can be below the stem and can fit into the groove of the frame as it lies atop a textured interior (e.g., interior surface) of the bracket frame. The textured interior can ensure that the bracket component does not move freely within the space (e.g., groove, compartment) created by the bracket frame. The diameter of the bracket stem can be smaller than the opening created by the frame such that the bracket stem fits within the opening. The base of the stem can be wider than the stem, and can be narrower than the frame. When the frame is in passive form, or when the bracket system is unlocked, vertical pressure is relieved from the slot component, and less frictional force (or no substantial frictional force) is generated between the base of the component and the textured interior surface of the frame. When the frame is in active form, or when the bracket system is locked, the vertical pressure is increased either by decreasing the distance between the two members of the frame or by insertion of the plate. In this instance, the bracket base is constrained between the two members so that it cannot freely move. This can create an increased vertical pressure and can increase the frictional force between the bracket base and the frame's textured interior surface to the point that the slot becomes substantially stationary. [0093] According to this particular embodiment explained above, when the frame is unlocked, the slot component can freely rotate 360 degrees around the central longitudinal axis (e.g., the axis that extends along the direction between the center of the base and the center of the bracket slot) of the stem. The slot can also slide (as the arms slide) to any direction within the area defined by the frame boundaries, and to the limit that the slot stem comes in contact with the frame boundaries. [0094] The exterior surface of the frame that is designed to contact a tooth (e.g., the exterior surface of the anchoring member) can be serrated, meshed, or made rough in any other way to increase bond strength. The exterior surface of the frame that is designed to contact a tooth can have adaptive curves associated with the morphology of tooth surface, whereas the side of the frame that faces the bracket (e.g., the exterior surface of the frame that is closest to the slot of the bracket) need not be so morphologically processed. The bottom surface of the bracket base and the base-facing-side of the frame (e.g., the interior surface) can have micro-projections, or other friction enhancing properties, to prevent or reduce the probability of sliding of the slot when the frame is locked. In some embodiments, there also is a high frictional coefficient between the bottom part of the arms and the top external part of the receiving members. [0095] Locking the frame can be accomplished by a variety of mechanisms. For example, screws can be used. Alternatively, a plate can be used that is slid under the bracket. Tightening of the screws can create vertical pressure between the frame components that hold the slot component and this can lead to increased friction between the bracket base and frame's textured interior surface to the point at which the slot component becomes substantially stationary (e.g., does not move more than 1%, 2%, 3%, 4%, 5%, 10% of its length in any direction in a given day, week, or month). [0096] Another method of locking the frame can incorporate an undercut (e.g., a clip that extends from the part of the frame that is set to contact a tooth) as a part of the frame. Similar to the way a locking pin (e.g., a screw, as described) can work, the component of the frame that is designed to be away from a tooth can be squeezed under the undercut, which can create a desired vertical pressure necessary to increase a frictional force to prevent the slot component from substantially moving. [0097] Another feature found in some embodiments of the present invention is the presence of markings on the bracket as well as the frame. Markings can be placed anywhere on any of the components of the bracket system. These markings can allow a user to quantify the amount of movement in any direction. Borders of the frame can be marked similar to those of a ruler and the bracket can have reference points. At any given time, a user can determine the amount of movement in any direction by comparing the position of the reference points (e.g., orthogonal bracket markings, oblique bracket markings) on the bracket with the measurements (e.g., coarse orthogonal markings, fine orthogonal markings, and oblique markings) on the frame. This can also allow a user to reset the bracket tip and torque at any given time by aligning the bracket with the frame. [0098] The present invention involves methods of using bracket system described herein. The steps of the method include anchoring the frame of the bracket system onto the tooth using an adhesive (e.g., bonding material). An embodiment of the method of the present invention includes placing the bracket into the frame and securing the bracket into a position within the frame. The way the bracket is locked into position varies depending on the frame being used, but, for example, the frame can be fastened using the clip, screws or lever, as described herein. The steps of the method include positioning the bracket in the frame (e.g., within one of the lobes and/or rotating the bracket) to achieve the desired movement and positioning of the teeth. Once the bracket is in place, the teeth are allowed to move for a period of time (e.g., about 1 day to about 3 months, and preferably between about 1 and about 4 weeks) until the next adjustment of the bracket. At the next visit, the dental practitioner does not need to re-position the frame and rebond the frame to the tooth. The dental practitioner simply readjusts the bracket within the frame by unlocking the frame, re-positioning the bracket, and locking the frame. Accordingly, the method of the present invention further includes re-positioning the bracket without having to rebond the frame, which can be done repeatedly over a multitude of visits, to allow the teeth to continue to move into the desired position. [0099] The relevant teachings of all the references, patents and/or patent applications cited herein are incorporated herein by reference in their entirety. [0100] While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.

1a

BACKGROUND OF THE INVENTION 1. Field of Invention This invention relates to 5-[(4-aryl or heteroaryl-1-piperazinyl)alkyl]-2-oxazolidinones that have anxiolytic properties and a pharmaceutical composition for treating anxiety in warm blooded animals, including humans. 2. Information Disclosure Statement U.S. Pat. No. 3,419,559, 3,455,941; 3,457,267 and 3,513,236 disclose oxazolidinones including those of Formula A: ##STR3## wherein R is H, loweralkyl, cycloalkyl or benzyl; R' is H or loweralkyl independently; R" is H or loweralkyl independently; n is 1 or 2; and Ar is phenyl or substituted phenyl. Compounds of Formula A are disclosed as having tranquilizer and analgetic properties. Intermediates useful in preparing compounds of Formula A are disclosed in U.S. Pat. No. 3,423,418. U.S. Pat. No. 4,886,794 discloses antiallergy 2-oxazolidinones of Formula B which encompasses. ##STR4## the 5-substituted oxazolidinones. A copending U.S. application, Ser. No. 07/633,030 filed Dec. 24, 1990 discloses antiallergy properties of certain 5-[(4-aryl-1-piperazinyl)alkyl]-2-oxazolidinones. SUMMARY OF THE INVENTION The compounds useful in the method and pharmaceutical composition of this invention are represented by Formula I below: ##STR5## Under Formula I, n is 3 or 4, R is C 1 -C 4 alkyl or phenyl, Ar is ##STR6## where Z is H, C 1 -C 4 alkoxy, C 2 -C 4 alkenyloxy or hydroxy. Also encompassed by Formula I are the stereoisomers and pharmaceutically acceptable salts. More specifically, C 1 -C 4 alkyl includes methyl, ethyl, propyl, isopropyl, butyl, sec-butyl, isobutyl, and tertiary butyl; C 1 -C 4 alkoxy includes methoxy, ethoxy, propoxy, 2-propyloxy, butoxy, 2-butyloxy, isobutyloxy, and t-butyloxy; C 2 -C 4 alkenyloxy includes vinyloxy, 2-propenyloxy, 2-(or 3)-butenyloxy and the like. The term pharmaceutically acceptable salts includes hydrates, solvates, and acid addition slats formed from inorganic or organic acids such as hydrochloric, hydrobromic, sulfuric, phosphoric, maleic, succinic, fumaric, citric, hexamic, tartaric and ethanesulfonic acids and the like. Anxiolytic properties were determined using an in vitro assay in which competive binding with the 5-HT 1A specific agonist, [ 3 H]8-hydroxy-2-(di-n-propylamino)tetralin(8-OH-DPAT) to 5HT 1A receptors in the dog hippocampus membrane preparation is measured [Hall et al, J. Neurochem. 44, 1685-1696 (1985)]. Anxiolytic agents that bind selectively to the 5-HT 1A receptor are of the class of anxiolytics represented by buspirone (Buspar®), gepirone, and ipsapirone. Several compounds were also tested in mice is the exploratory light/dark method as described by Young and Johnson, Soc. Neurosci. Abs. 1988, 14, 207 in which the exploratory behavior of a mouse is a two-compartment light-dark activity box is monitored electrically and behavioral variables such as time spent in the lit versus dark compartments, rearings in either of the two compartments, number of transitions between the two compartments and other exploratory behavioral variables are recorded. Significant increases in one or more of the variables associated with the exploratory behavior of the animal in the lit area versus the dark area correspond to active non-sedating anxiolytic compounds. DETAILED DESCRIPTION OF THE INVENTION The compounds useful in this invention are prepared following procedures previously disclosed in U.S. Pat. Nos. 3,419,559; 3,455,941; 3,457,267; 3,513,236 and 4,886,794 and in J. Pharm. Sci. 58(3), 362-364 and are hereby incorporated by reference. The invention compounds are prepared according to Scheme A. ##STR7## This reaction is typically performed using a polar solvent such as ethanol, butanol, or dimethyl formamide at or near the boiling point of the solvent with an acid acceptor such as sodium carbonate, potassium carbonate or sodium bicarbonate present. Potassium iodide may be used to catalyze the reaction. The product is isolated and purified by conventional methods. Scheme B indicates the reaction used to obtain the alkenyloxy substituted invention compounds. ##STR8## The 5-haloalkyl-2-oxazolidinones are obtained from the appropriate N-substituted aminomethyltetrahydrofuran or the corresponding tetrahydropyran according to Scheme C. ##STR9## This ring-opening/ring closure reaction is carried out in an aprotic solvent at or below ambient temperature. The precursor substituted aminomethyltetrahydrofuran or pyran are prepared from the commercially available 2-(chloromethyl)tetrahydrofuran or pyran and the desired amine as shown in Scheme D. ##STR10## Excess amine serves as the solvent in the procedure of Scheme D. The above procedures are broadly described and actual reaction conditions will depend on the reaction temperatures, solvents, purity of reactants and the like. The following Preparations and Examples are illustrative of the above reaction schemes and should not be construed as limiting to this disclosure in any way. Reactants for which no preparative procedure is given are either commercially available or readily prepared using published procedures. It is expected that one skilled in the art would be able to carry out this invention without undue experimentation. PREPARATION 1 Tetrahydro-N-(1-methylethyl)-2H-pyran-2-methanamine ethanedioate (1:1). A solution of 2-(bromomethyl)tetrahydro-2H-pyran (100 g, 0.558 mol) and isopropylamine (66.0 g, 1.12 mol) was refluxed under nitrogen overnight, and the solvent was removed under reduced pressure. A 3N hydrochloric acid solution was added to acidify the residue, and the solution was washed twice with ether and made basic with a 50% sodium hydroxide solution. The product was extracted twice into ether, and the combined extracts were washed twice with a saturated sodium chloride solution, dried (sodium sulfate),filtered, and evaporated under reduced pressure to an oil (54.8 g, 62% yield). A portion of the oil (13.7 g, 0.0873 mol) was dissolved in warm 2-propanol and a solution of oxalic acid (7.86 g, 0.0873 mol) in warm 2-propanol was added. A solid precipitated, which was collected by filtration and dried under high vacuum at 60° C. to give 17.24 g, mp 172°-175° C. Analysis: Calculated for C 11 H 12 NO 8 : C, 53.43; H, 8.56; N, 5.66; Found: C, 53.54; H, 8,94; N, 5.60. PREPARATION 2 Tetrahydro-N-phenyl-2H-pyran-2-methanamine. A mixture of 2-(bromomethyl)tetrahydro-2H-pyran (100 g, 0.558 mol) and aniline (155.96 g, 1.67 mol) was heated at 100° C. under nitrogen overnight and cooled to room temperature. A 3N hydrochloric acid solution (400 mL) was added and the aqueous layer was washed three times with isopropyl ether. The aqueous layer was made basic with 50% sodium hydroxide solution, and the product was extracted three times into isopropyl ether. The combined organic extracts were washed once with water and evaporated under reduced pressure. The resulting oil was poured into water (1400 mL) and stirred. The water was decanted and water (1500 mL) was again added. The aqueous layer was again decanted and the oil was triturated again in water (1500 mL) to give a solid, which was recrystallized from methanol/water and dried under high vacuum to give 78.5 g of product containing one mole of water (67% yield). A 2.0 g portion was recrystallized from methanol/water and dried under high vacuum to give 0.71 g, mp 55°-58° C. Analysis: Calculated for C 12 H 17 NO: C, 75.35; H, 8,96; N, 7.32; Found: C, 75.33; H, 9.15; N, 7.25. PREPARATION 3 Tetrahydro-N-phenyl-2-furanmethanamine ethanediodate (1:1). A mixture of tetrahydrofurfuryl chloride (100 g, 0.829 mol), aniline (2.09 g, 2.25 mol) and potassium iodide (1.0 g) was heated at 130° C. under nitrogen for 36 hours and cooled to room temperature. A 3N hydrochloric acid solution (400 mL) was added and the solution was washed several times with isopropyl ether and made basic with a 50% sodium hydroxide solution. The product was extracted three times into isopropyl ether, washed twice with water and once with a saturated sodium chloride solution, dried (sodium sulfate), filtered and evaporated to a liquid that was added to water (3L) and extracted into three portions of isopropyl ether. The combined extracts were washed twice with water and once with a saturated sodium chloride solution, dried (magnesium sulfate), treated with charcoal, filtered and evaporated under reduced pressure to a liquid (91.4 g). A 6.0 g portion was dissolved in isopropanol and a solution of oxalic acid (3.1 g) in isopropanol was added. The resulting solid was collected by filtration and rinsed with isopropyl ether to give 6.3 g of solid. A 1.5 g portion was recrystallized from isopropanol/isopropyl ether/light pet ether to give a solid that was removed by filtration. A second crop of crystals was obtained from the filtrate, dried under high vacuum at 60° C. to give 0.31 g, mp 149°-156° C. Analysis: Calculated for C 13 H 17 NO 5 : C, 58.42; H, 6.41; N, 5.24; Found: C, 57.99; H, 6.41; N, 5.37. PREPARATION 4 5-(4-Chlorobutyl)-3-(1-methylethyl)-2-oxazolidinone. A solution of phosgene (287 mL of a 20% solution, 273 g, 0.55 mol) in toluene and additional toluene (100 mL) was cooled to -10° C. by an ice/methanol bath and a solution of tetrahydro-N-(1-methylethyl)-2H-pyran-2-methanamine (41.13 g, 0.262 mol) and triethylamine (27.9 g, 0.276 mol) in toluene (300 mL) was added dropwise, keeping the temperature below 5° C. The mixture was warmed to room temperature and refluxed under nitrogen for 30 min. Zinc chloride (0.65 g) was added and refluxing was continued for 15 min. An additional portion of zinc chloride (0.32 g) was added, and the mixture was refluxed for 24 hr and allowed to stand at room temperature for several days. Water (750 mL) was added, and the layers were separated. The organic layer was washed twice again with water and once with a saturated sodium chloride solution, dried (magnesium sulfate), treated with charcoal, filtered, and evaporated to an oil. The oil was distilled under reduced pressure, and the fraction distilling from 148°-165° C./0.3 mm was collected to give 46.7 g (81% yield). Analysis: Calculated for C 10 H 18 NO 2 Cl: C, 54.67; H, 8.26; N, 6.38; Found: C, 53.37; H, 8.37; N, 6.15. PREPARATION 5 5-(3-Chloropropyl)-3-phenyl-2-oxazolidinone. To a solution of phosgene in toluene (342 g of a 20% solution, 0.693 mol) was added additional toluene (150 mL) and the solution was cooled to -10° C. in an ice/methanol bath. Dropwise, keeping the temperature below 5° C., a solution of 2-phenylaminomethyltetrahydrofuran (58.4 g, 0.330 mol) and triethylamine (35.1 g, 0.348 mol) in toluene (400 mL) was added. The mixture was warmed to room temperature and then refluxed for 30 minutes. Zinc chloride (0.82 g) was added and refluxing was continued for 15 minutes. An additional portion of zinc chloride (0.41 g) was added and the mixture was refluxed under nitrogen for 24 hours. The mixture was washed twice with water, once with a saturated sodium chloride solution, dried (sodium sulfate), filtered, and evaporated under reduced pressure to an oil, which crystallized upon standing (70.7 g, 89% yield). Recrystallization from isopropanol/isopropyl ether gave 47.0 g of solid, from which a 1.5 g portion was again recrystallized from isopropanol/isopropyl ether and dried under high vacuum to give 1.18 g, mp 76°-79° C. Analysis: Calculated for C 12 H 14 NO 2 Cl: C, 60.13; H, 5.89; N, 5.84; Found: C, 60.11; H, 5.97; N, 5.81. PREPARATION 6 5-(4-Chlorobutyl)-3-phenyl-2-oxazolidinone. To a 20% solution of phosgene in toluene (273 g of solution, 0.55 mol) was added toluene (100 mL) and the solution was stirred in an ice/methanol bath. A solution of 2-phenylaminomethyltetrahydropyran (50.0 g, 0.262 mol) and triethylamine (27.9 g, 0.276 mol) in toluene (300 mL) was added dropwise, keeping the temperature below 5° C. The mixture was warmed to room temperature and then refluxed for 30 minutes. Zinc chloride (0.65 g) was added and the mixture was refluxed for 15 minutes. An additional portion of zinc chloride (0.32 g) was added and the mixture was refluxed for 10 minutes and stirred at room temperature for 3 days. The mixture was again refluxed for 24 hours, cooled to room temperature, washed twice with water, and twice with a saturated sodium chloride solution, dried (magnesium sulfate), treated with charcoal, filtered, and evaporated under reduced pressure to give 57.8 g (87% yield) of solid, which was recrystallized from isopropanol/isopropyl ether to give 38.0 g of product. A 1.5 g portion was gain recrystallized from isopropanol/isopropyl ether and dried under high vacuum to give 0.92 g, mp 65°-69° C. Analysis: Calculated for C 13 H 16 NO 2 Cl: C, 61.54; H, 6.36; N, 5.52; Found: C, 61.50; H, 6.44; N, 5.50. EXAMPLE 1 3-Methyl-5-[4-(4-phenyl-1-piperazinyl)butyl]-2-oxazolidinone. A mixture of 5-(4-chlorobutyl)-3-methyl-2-oxazolidinone (10.0 g, 0.0524 mol), 1-phenylpiperazine hydrochloride (0.0524 mol, 10.39 g), potassium carbonate (28.94 g, 0.209 mol) and potassium iodide (1.0 g) was refluxed in 1-butanol (150 mL) for 24 hr and then stirred at room temperature for two days. The mixture was reheated to boiling and filtered hot. Methanolic hydrogen chloride was added to acidify the filtrate and addition of isopropyl ether caused a solid to precipitate. The solid was collected by filtration and dissolved in water. Potassium carbonate was added to make the solution basic and the product was extracted into two portions of ethyl acetate. The combined ethyl acetate layers were washed twice with water, three times with a saturated sodium bicarbonate solution and once with a saturated sodium chloride solution. The solution was dried (sodium sulfate), filtered, and evaporated under reduced pressure to an oil. Addition of isopropyl ether gave a solid which was recrystallized from isopropyl ether/methanol. The solid was collected by filtration, rinsed with light pet ether and dried under high vacuum to give 7.51 g (45% yield), mp 85°-88° C. Analysis: Calculated for C 18 H 27 N 3 O 2 : C, 68.11; H, 8.57; N, 13.24; Found: C, 68.10; H, 8.68; N, 13.28. EXAMPLE 2 3-Methyl-5-[4-[4-(2-pyridinyl)-1-piperazinyl]butyl]-2-oxazolidinone. Following the procedure of Example 1, the title compound is prepared from a mixture of 5-(4-chlorobutyl)-3-methyl-2-oxazolidinone (5.0 g, 0.0262 mol), 1-(2-pyridinyl)piperazine (4.56 g, 0.0279 mol) and potassium carbonate (8.5 g, 0.0614 mol) in 1-butanol (50 ml) to obtain 3.4 g (41% yield) of solid. Recrystallization from ethyl acetate/petroleum ether followed by drying in vacuo gave 1.46 g of the title compound, mp 69°-72° C. Analysis: Calculated for C 17 H 26 N 4 O 2 : C, 64.12; H, 8.23; N, 17.60; Found: C, 64.01; H, 8.29; N, 17.58. EXAMPLE 3 5-[4-[4-(2-Methoxyphenyl)-1-piperazinyl]butyl]-3-methyl-2-oxazolidinone dihydrochloride. Following the procedures of Example 1, the title compound is prepared. Thus, a mixture of 5-(4-chlorobutyl)-3-methyl-2-oxazolidinone (5.0 g, 0.0262 mol), 1-(2-methoxyphenyl)piperazine (5.4 g. 0.0279 mol), potassium carbonate (8.5 g, 0.0614 mol), and potassium iodide (0.75 g) in 1-butanol (50 ml) gave 6.8 g of oil which was dissolved in hot methanol and acidified with methanolic hydrogen chloride. Addition of isopropyl ether and isopropanol to the cloud point and cooling gave a solid which was collected by filtration, rinsed with isopropyl ether and light pet ether and dried under high vacuum to give 4.22 g (38% yield), mp 209°-216° C. Analysis: Calculated for C 19 H 29 N 3 O 3 .2HCl: C, 54.28; H, 7.43; N, 10.00; Found: C, 54.16; H, 7.72; N, 9.98. EXAMPLE 4 3-Methyl-5-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-2-oxazolidinone. Following the procedure of Example 1, mixture of 5-(4-chlorobutyl)-3-methyl-2-oxazolidinone (5.0 g, 0.0262 mol), 1-(2-pyrimidinyl)piperazine dihydrochloride (6.62 g, 0.0279 mol), potassium carbonate (19.3 g, 0.140 mol) and potassium iodide (0.75 g) in 1-butanol (75 ml) gave an oil (3.0 g) which crystallized upon standing. Recrystallization from ethyl acetate/light pet ether followed by drying under high vacuum gave 1.33 g (16% yield), mp 74°-76° C. Analysis: Calculated for C 16 H 25 N 5 O 2 : C, 60.17; H, 7.89; N, 21.92; Found: C, 60.02; H, 8.02; N, 21.96. EXAMPLE 5 5-[3-[4-(2-Methoxyphenyl)-1-piperazinyl]propyl]-3-methyl-2-oxazolidinone hydrochloride hydrate (2:2:3). A mixture of 5-(3-chloropropyl)-3-methyl-2-oxazolidinone (5.0 g, 0.0282 mol), 1-(2-methoxyphenyl)piperazine (5.43 g, 0.0282 mol), potassium carbonate (11.71 g, 0.0847 mol), and potassium iodide (0.5 g) in 1-butanol (75 mL) was refluxed for 24 hours under nitrogen and filtered hot. A 3N hydrochloride acid solution was added to acidify the filtrate, and the aqueous solution was washed twice with isopropyl ether. The aqueous solution was made basic with potassium carbonate, and the product was extracted into two portions of ethyl acetate. The combined ethyl acetate layers were washed three times with water and once with a saturated sodium chloride solution, dried (sodium sulfate), filtered, and evaporated under reduced pressure to an oil (7.1 g, 76% yield). The oil was dissolved in hot isopropanol, acidified with ethereal hydrogen chloride, and allowed to cool. The resulting solid was collected by filtration, rinsed with diethyl ether, and dried under high vacuum at 60° to give 6.92 g, mp 199°-202° C. Analysis: Calc. for C 18 H 27 N 3 O 3 .HCl.1.5H 2 O: C, 54.47; H, 7.87; N, 10.59; Found: C, 54.23; H, 7.53; N, 10.50. EXAMPLE 6 3-Methyl-5-[3-[4-(2-pyridinyl)-1-piperazinyl]propyl]-2-oxazolidinone hydrochloride hydrate (2:4:1). Following the procedure of Example 5, a mixture of 5-(3-chloropropyl)-3-methyl-2-oxazolidinone (5.0 g, 0.0282 mol), 1-(2-pyridinyl)piperazine (4.61 g, 0.0282 mol), potassium carbonate (11.71 g, 0.0847 mol), and potassium iodide (0.5 g) in 1-butanol (75 mL) gave an oil (4.2 g, 49% yield). The oil was dissolved in hot isopropanol and acidified with ethereal hydrogen chloride. Methanol was added to make a solution. Upon cooling, a solid precipitated which was collected by filtration, rinsed with diethyl ether, and dried under high vacuum at 60° C. to give 3.66 g, mp 214°-218° C. Analysis: Calc. for C 16 H 24 N 4 O 2 .2HCl.0.5H 2 O: C, 49.74; H, 7.04; N, 14.50; Found: C, 49.73; H, 7.22; N, 14.51. EXAMPLE 7 3-Methyl-5-[3-[4-(2-pyrimidinyl)-1-piperazinyl]propyl]-2-oxazolidinone. Following the procedure of Examples 5, 5-(3-chloropropyl)-3-methyl-2-oxazolidinone (5.0 g, 0.0282 mol), 1-(2-pyrimidinyl)piperazine dihydrochloride (6.70 g, 0.0282 mol), potassium carbonate (23.4 g, 0.1695 mol), and potassium iodide (0.5 g) in 1-butanol (100 mL) gave an oil (3.5 g, 41% yield) which was dissolved in a hot mixture of isopropyl ether and isopropanol, filtered hot, and brought to the cloud point by the addition of light pet ether. Upon cooling, a solid precipitated which was collected by filtration, rinsed with light pet ether, and dried under high vacuum to give 1.38 g, mp 79°-89° C. Analysis: Calculated for C 15 H 23 N 5 O 2 : C, 59.00; H, 7.59; N, 22.93; Found: C, 58.96; H, 7.75; N, 22.91. EXAMPLE 8 5-[3-[4-(2-Ethoxyphenyl)-1-piperazinyl]propyl]-3-methyl-2-oxazolidinone. Following the procedure of Example 5, a mixture of 5-(3-chloropropyl)-3-methyl-2-oxazolidinone (5.0 g, 0.0282 mol), 1-(2-ethoxyphenyl)piperazine monohydrochloride (6.86 g, 0.0282 mol), potassium carbonate (15.62 g, 0.113 mol), and potassium iodide (1.0 g) in n-butanol (100 mL) gave an oil (4.5 g, 46% yield). The oil was triturated in warm isopropyl ether and the resulting suspension was stirred at room temperature. The solid was collected by filtration, rinsed with light pet ether and dried under high vacuum to give 2.58 g, mp 79°-81° C. Analysis: Calculated for C 19 H 29 N 3 O 3 : C, 65.68; H, 8.41; N, 12.09; Found: C, 65.80; H, 8.55; N, 12.07. EXAMPLE 9 5-[4-[4-(2-Ethoxyphenyl)-1-piperazinyl]butyl]-3-methyl-2-oxazolidinone dihydrochloride. Following the procedure of Example 5, a mixture of 5-(2-chlorobutyl)-3-methyl-2-oxazolidinone (5.2 g, 0.0272 mol), 1-(2-ethoxyphenyl)piperazine monohydrochloride (6.61 g, 0.0272 mol), potassium carbonate (15.05 g, 0.109 mol), and potassium iodide (1.0 g) in n-butanol (100 mL) gave an oil which was dissolved in a mixture of ethyl acetate/isopropyl ether/light pet ether (removing the impurities by filtration) and acidified with ethereal hydrogen chloride. The mixture was evaporated under reduced pressure and recrystallized once from isopropanol/methanol/isopropyl ether and then from isopropanol/isopropyl ether and dried under high vacuum at 60° C. to give 1.18 g (10% yield), mp 207°-212° C. Analysis: Calculated for C 20 H 31 N 3 O 3 .2HCl: C, 55.30; H, 7.66; N, 9.67; Found: C, 55.14; H, 7.79; N, 9.61. EXAMPLE 10 5-[3-[4-(2-hydroxyphenyl)-1-piperazinyl]propyl]-3-methyl-2-oxazolidinone. Following the procedure of Example 5, a mixture of 1-(2-hydroxyphenyl)piperazine dihydrobromide (9.6 g, 0.0282 mol), 5-(3-chloropropyl)-3-methyl-2-oxazolidinone (5.0 g, 0.0282 mol), sodium bicarbonate (9.5 g, 0.113 mol), and potassium iodide in 1-butanol (100 ml) gave an oil. The oil was triturated several times with light pet ether (decanting each time) and dissolved in ethyl acetate/isopropyl ether. Cooling the solution gave a solid which was collected by filtration and dried under high vacuum to give 1.80 g (20% yield), mp 112°-116° C. Analysis: Calculated for C 17 H 25 N 3 O 3 : C, 63.93; H, 7.89; N, 13.16; Found: C, 63.71; H, 8.01; N, 13.04. EXAMPLE 11 b 5-[4-[4-(2-Hydroxyphenyl)-1-piperazinyl]butyl]-3-methyl-2-oxazolidinone. Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-methyl-2-oxazolidinone (5.39 g, 0.0282 mol), 1-(2-hydroxyphenyl)-piperazine dihydrobromide (9.6 g, 0.0282 mol), sodium bicarbonate (9.5 g, 0.113 mol) and potassium iodide (1.0 g) in n-butanol (100 mL) gave an oil which was triturated in light pet ether several times, crystallized from ethyl acetate/isopropyl ether, and dried under high vacuum at 50° C. to give 3.22 g (34% yield), mp 106°-110°. Analysis: Calculated for C 18 H 27 N 3 O 3 : C, 64.84; H, 8.16; N, 12.60; Found: C, 64.79; H, 8.36; N, 12.54. EXAMPLE 12 8-methyl-5-[4-[4-[2(2-propenyloxy)phenyl]-1-piperazinyl]butyl]-2-oxazolidinone hydrochloride hydrate (2:4:1). To a stirring solution of 5-[4-[4(2-hydroxyphenyl)-1-piperazinyl]butyl-3-methyl-2-oxazolidinone (5.0 g, 0.0150 mol ) in absolute ethanol (150 mL) was added a solution of potassium hydroxide (0.93 g, 0.0165 mol) in absolute ethanol (100 mL). The mixture was stirred at room temperature for 30 minutes and allyl bromide (2.00 g, 0.0165 mol) was added. The mixture was stirred at room temperature for 3 hr and acidified with a 3N hydrochloric acid solution. The solvents were removed under reduced pressure and a saturated sodium bicarbonate solution and ethyl acetate were added. The layers were separated and the aqueous layer was extracted again with ethyl acetate. The combined organic layers were washed twice with a saturated sodium chloride solution, twice with a 5% potassium hydroxide solution, once more with a saturated sodium chloride solution, dried (sodium sulfate), filtered, and evaporated under reduced pressure to 3.7 g of a liquid, which was dissolved in absolute ethanol and acidified with ethanolic hydrogen chloride. The solid was collected by filtration, rinsed with diethyl ether and dried under high vacuum at 60° C., giving 3.15 g (46% yield), mp 197°-200° C. Analysis: Calc. for C 21 H 31 N 3 O 3 .2HCl.0.5H 2 O: C, 55.38; H, 7.52; N, 9.23; Found: C, 55.93; H, 7.62; N, 9.36. EXAMPLE 13 5-[4-[4-(2-Methoxyphenyl)-1-piperazinyl]butyl]-3-phenyl-2-oxazolidinone hydrochloride hydrate (2:2:1). Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-phenyl-2-oxazolidinone (3.0 g, 0.01186 mol), 1(2methyoxyphenyl)-piperazine (2288g, 0.01186 mol), potassium carbonate (4.92 g, 0.0356 mol) and potassium iodide (1 g) in 1-butanol (75 ml) gave an oil (4.7 g, 87% yield), which was crystallized from isopropanol/isopropyl ether. Drying of the resulting solid under high vacuum gave 0.98 g, mp 153°-155° C. Analysis: Calc. for C 24 H 31 N 3 O 3 .HCl.0.5H 2 O: C, 63.36; H, 7.31; N, 9.24; Found: C, 63.60; H, 7.33; N, 9.12. EXAMPLE 14 3-Phenyl-5-[4-[4-(2-pyridinyl)-1-piperazinyl]butyl]-2-oxazolidinone. Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-phenyl-2-oxazolidinone (3.0 g, 0.01186 mol), 1-(2-pyridinyl)piperazine (1.94 g, 0.01186 mol), potassium carbonate (4.92 g, 0.0356 mol), and potassium iodide (1.0 g) in n-butanol (75 mL) gave an oil, which crystallized upon standing (3.9 g, 86% yield). The solid was recrystallized from isopropanol/isopropyl ether and dried under high vacuum to give 1.80 g, mp 78°-81° C. Analysis: Calculated for C 22 H 28 N 4 O 2 : C, 69.45; H, 7.42; N, 14.72; Found: C, 69.33; H, 7.51; N, 14.56. EXAMPLE 15 3-Phenyl-5-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-2-oxazolidinone. Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-phenyl-2-oxazolidinone (3.0 g, 0.01186 mol), 1-(2-pyrimidinyl)piperazine dihydrochloride (2.81 g, 0.01186 mol), potassium carbonate (9.85 g, 0.0713 mol), and potassium iodide (1.0 g) in n-butanol (75 mL) gave a solid (4.1 g, 91% yield). The solid was recrystallized from isopropanol/isopropyl ether and dried under high vacuum to give 2.58 g, mp 94°-96° C. Analysis: Calculated for C 21 H 27 N 5 O 2 : C, 66.12; H, 7.13; N, 18.36; Found: C, 66.04; H, 7.17; N, 18.29. EXAMPLE 16 3-Phenyl-5-[4-(4-phenyl-1-piperazinyl)butyl]-2-oxazolidinone. Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-phenyl-2-oxazolidinone (3.0 g, 0.01186 mol), 1-phenylpiperazine hydrochloride (2.35 g, 0.01186 mol), potassium carbonate (6.54 g, 0.0473 mol), and potassium iodide (1.0 g) in 1-butanol gave a liquid (4.1 g, 91% yield) which crystallized upon standing. Recrystallization from isopropanol/isopropyl/-ether and drying under high vacuum gave 1.44 g, mp 83°-85° C. Analysis: Calculated for C 23 H 29 N 3 O 2 : C, 72.79; H, 7.70; N, 11.07; Found: C, 72.76; H, 7.90; N, 10.86. EXAMPLE 17 5-[4-[4-(2-hydroxyphenyl)-1-piperazinyl]butyl]-3-phenyl-2-oxazolidinone. Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-phenyl-2-oxazolidinone (6.0 g, 0.0237 mol), 1-(2-hydroxyphenyl)piperazine dihydrobromide (8.06 g, 0.0237 mol), sodium bicarbonate (7.98 g, 0.095 mol), and potassium iodide (1.0 g) in n-butanol (200 mL) gave an oil (10.5 g) which crystallized on standing and was recrystallized from isopropanol/isopropyl ether. Drying under high vacuum gave 6.15 g (66% yield), mp 123°-129° C. Analysis: Calculated for C 23 H 29 N 3 O 3 : C, 69.85; H, 7.39; N, 10.62; Found: C, 69.72; H, 7.52; N, 10.44. EXAMPLE 18 5-[4-[4-(2-Ethoxyphenyl)-1-piperazinyl]butyl]-3-phenyl-2-oxazolidinone hydrochloride hydrate (2:4:1). Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-phenyl-2-oxazolidinone, (3.0 g, 0.01186 mol), 1-(2-ethoxyphenyl)piperazine hydrochloride (2.88 g, 0.01186 mol), potassium carbonate (6.57 g, 0.0475 mol), and potassium iodide (1.0 g) in n-butanol (100 mL) gave an oil (3.5 g, 79% yield). The oil was dissolved in ethanolic hydrogen chloride and allowed to stand. Diethyl ether was added to give a solid which was collected by filtration. After recrystallization the solid weighted 3.64 g, mp 215°-223° C. Analysis: Calc. for C 26 H 33 N 3 O 3 .2HCl.0.5H 2 O: C, 59.40; H, 7.18; N, 8.31; Found: C, 59.24; H, 7.22; N, 8.44. EXAMPLE 19 3-Phenyl-5-[3-[4-(2-pyridinyl)-1-piperazinyl]propyl]-2-oxazolidinone. Following the procedure of Example 5, a mixture of 5-(3-chloropropyl)-3-phenyl-2-oxazolidinone (4.5 g, 0.0188 mol), 1-(2-pyridinyl)piperazine (3.07 g, 0.0188 mol), potassium carbonate (7.81 g, 0.0565 mol), and potassium iodide (1.0 g) in n-butanol (200 mL) gave a solid which was recrystallized from isopropanol/isopropyl ether and dried under high vacuum to give 3.86 g (56% yield), mp 123°-125° C. Analysis: Calculated for C 21 H 26 N 4 O 2 : C, 68.83; H, 7.15; N, 15.29; Found: C, 68.70; H, 7.16; N, 15.22. EXAMPLE 20 3-Phenyl-5-[3-[4-(2-pyrimidinyl)-1-piperazinyl]propyl]2-oxazolidinone. Following the procedure of Example 5, a mixture of 5-(3-chloropropyl)-3-phenyl-2-oxazolidinone (4.5 g, 0.0188 mol), 1-(2-pyrimidyl)piperazine dihydrochloride (4.47 g, 0.0188 mol), potassium carbonate (15.64 g, 0.113 mol), and potassium iodide (1.0 g) in n-butanol (200 mL) gave a solid which was recrystallized from isopropanol/isopropyl ether and dried under high vacuum to give 2.49 g (36% yield), mp 92°-98° C. and 118° C. Analysis: Calculated for C 20 H 25 N 5 O 2 : C, 65.37; H, 6.86; N, 19.05; Found: C, 65.27; H, 6.85; N, 19.01. EXAMPLE 21 5-[3-[4-(2-Ethoxyphenyl)-1-piperazinyl]propyl]-3-phenyl-2-oxazolidinone hydrochloride hydrate (2:4:1). Following the procedure of Example 5, a mixture of 5-(3-chloropropyl)-3-phenyl-2-oxazolidinone (4.5 g, 0.0188 mol), 1-(2-ethoxyphenyl)piperazine hydrochloride (4.57 g, 0.0188 mol), potassium carbonate (10.42 ,g 0.0754 mol), and potassium iodide (1.0 g) in n-butanol (200 mL) gave an oil. Acidification with ethanolic hydrogen chloride followed by addition of diethyl ether gave a solid, which was collected by filtration and dried under high vacuum to give 3.97 g (43% yield), mp 182°-187° C. Analysis: Calculated for C 24 H 31 N 3 O 3 .HCl.0.5H 2 O: C, 58.66; H, 6.97; N, 8.55; Found: C, 58.63; H, 7.10; N. 8.30. EXAMPLE 22 3-Phenyl-5-[3-(4-phenyl)-1-piperazinyl]propyl]-2-oxazolidinone. Following the procedure of Example 5, a mixture of 5-(3-chloropropyl)-3-phenyl-2-oxazolidinone (4.5 g, 0.0188 mol), 1-phenylpiperazine hydrochloride (3.74 g, 0.0188 mol), potassium carbonate (10.38 g, 0.0751 mol), and potassium iodide (1.0 g) in n-butanol (200 mL) gave a solid (6.2 g, 90% yield), Recrystallization from isopropanol/isopropyl ether and drying under high vacuum gave 2.60 g, mp 125°-127° C. Analysis: Calculated for C 22 H 27 N 3 O 2 : C, 72.30; H, 74.5; N, 11.50; Found: C, 72.05; H, 7.48; N, 11.40. EXAMPLE 23 5-[3-[4-(2-Methoxyphenyl)-1-piperazinyl]propyl]-3-phenyl-2-oxazolidinone hydrochloride hydrate (1:2). Following the procedure of Example 5, a mixture of 5-(3-chloropropyl)-3-phenyl-2-oxazolidinone (4.5 g, 0.0188 mol), 1-(2-methoxyphenyl)-piperazine (3.62 g, 0.0188 mol), potassium carbonate (7.81 g, 0.0565 mol), and potassium iodide (1.0 g) in n-butanol (200 mL) gave an oil. The oil was acidified with warm ethanolic hydrogen chloride, filtered warm, and cooled to room temperature. Diethyl ether was added and the resulting solid was collected by filtration and dried under high vacuum at 50° C. to give 4.65 g (53% yield), mp 203°-211° C. Analysis: Calculated for C 23 H 29 N 3 O 3 .2HCl: C, 58.98; H, 6.67; N, 8.97; Found: C, 59.02; H, 6.89; N, 8.93. EXAMPLE 24 5-[3-[4-(2-Hydroxyphenyl)-1-piperazinyl]propyl]-3-phenyl-2-oxazolidinone hydrochloride (1:2). Following the procedure of Example 5, a mixture of 5-(3-chloropropyl)-3-phenyl-2-oxazolidinone (9.0 g, 0.0376 mol), 1-(2-hydroxyphenyl)piperazine dihydrobromide (12.80 g, 0.0377 mol), sodium bicarbonate (12.66 g, 0.151 mol), and potassium iodide (1.0 g) in n-butanol (400 mL) gave an oil (9.3 g, 65% yield). The oil was dissolved in warm absolute ethanol and acidified with ethanolic hydrogen chloride. Ether was added and the solid was collected by filtration and dried under high vacuum at 60° C. to give 8.28 g, mp 250° C. Analysis: Calculated for C 22 H 27 N 3 O 2 .2HCl: C, 58.15; H, 6.43; N, 9.25; Found: C, 58.00; H, 6.51; N, 9.20. EXAMPLE 25 3-Phenyl-5-[4-[4-[2-[2-propenyloxyl)phenyl]-1-piperazinyl]butyl]-2-oxazolidinone hydrochloride (1:2). A mixture of 5-[4-[4-(2-hydroxyphenyl)-1-piperazinyl]butyl]-3-phenyl-2-oxazolidinone (4.0 g, 0.0101 mol) and potassium hydroxide (0.62 g, 0.011 mol) in absolute ethanol (250 mL) was stirred at room temperature for two hours and allyl bromide (1.34 g, 0.0111 mol) was added. The mixture was stirred at room temperature for 4 days and then acidified with a 3N hydrochloric acid solution. The solvents were removed under reduced pressure and then the residue was dissolved in a saturated sodium bicarbonate solution. The product was extracted twice into ethyl acetate, washed once with water, twice with a 5% potassium hydroxide solution, once again with water and once with a saturated sodium chloride solution, dried (sodium sulfate), filtered and evaporated under reduced pressure to an oil (4.3 g, 98% yield). The oil was dissolved in warm absolute ethanol and acidified with ethanolic hydrogen chloride. The resulting solid was collected by filtration, rinsed with ether and dried under high vacuum at 50° C. to give 3.5 g, mp 198°-202° C. Analysis: Calculated for C 26 H 33 N 3 O 3 .2HCl: C, 61.41; H, 6.94; N, 8.26; Found: C, 60.98; H, 7.12; N, 8.18. EXAMPLE 26 3-Phenyl-5-[3-[4-[2-(2-propenyloxy)phenyl]-1-piperazinyl]propyl]-2-oxazolidinone hydrochloride hydrate (2:2:3). A mixture of 5-[3-[4-(2-hydroxyphenyl)-1-piperazinyl]propyl]-3-phenyl-2-oxazolidinone dihydrochloride (4.0 g, 0.0101 mol) and potassium hydroxide (0.62 g, 0.0111 mol) in absolute ethanol (250 mL) was stirred at room temperature for two hours and allyl bromide (1.34 g, 0.0111 mol) was added. The mixture was stirred at room temperature for 4 days and then acidified with a 3N hydrochloric acid solution. The solvents were removed under reduced pressure and a saturated sodium bicarbonate solution was added to the residue. The product was extracted twice into ethyl acetate and the combined extracts were washed once with water, twice with a 5% potassium hydroxide solution, once again with water and once with a saturated sodium chloride solution, dried (sodium sulfate), filtered and evaporated under reduced pressure to an oil (4.3 g, 98% yield). The oil was dissolved in warm absolute ethanol and acidified with ethanolic hydrogen chloride. The resulting solid was collected by filtration, rinsed with ether and dried under high vacuum at 50° C. to give 3.5 g, mp 198°-202° C. Analysis: Calculated for C 25 H 31 N 3 O 3 . HCl.1.5H 2 O: C, 61.91; H, 7.27; N, 8.66; Found: C, 62.19; H, 6.91; N, 8.84. EXAMPLE 27 5-[4-[4-(2-methoxyphenyl)-1-piperazinyl]butyl]-3-(1-methylethyl)-2-oxazolidinone hydrochloride (1:2). Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-(1-methylethyl)-2-oxazolidinone (5.2 g, 0.0237 mol), 1-(2-methoxyphenyl)piperazine (4.56 g, 0.0237 mol), potassium carbonate (9.84 g, 0.0712 mol) and potassium iodide (1.0 g) in n-butanol (200 mL) gave an oil. The oil was dissolved in absolute ethanol and acidified with ethanolic hydrogen chloride. Addition of ether gave a solid which was collected by filtration and dried under high vacuum at 70° C. to give 7.36 g (69% yield), mp 206°-213° C. Analysis: Calculated for C 21 H 33 N 3 O 3 .2HCl: C, 56.25; H, 7.87; N, 9.37; Found: C, 56.18; H, 8.13; N, 9.31. EXAMPLE 28 5-[4-[4-(2-Ethoxyphenyl)-1-piperazinyl butyl]-3-(1-methylethyl)-2-oxazolidinone hydrochloride (1:2). Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-(1-methylethyl)-2-oxazolidinone (5.2 g, 0.0137 mol), 1-(2-ethoxyphenyl)-piperazine hydrochloride (5.76 g, 0.0237 mol) and potassium iodide (1.0 g) in N-butanol (200 mL) gave an oil. The oil was dissolved in absolute ethanol and acidified with ethanolic hydrogen chloride. Addition of ether and filtration gave a solid which was dried under high vacuum at 70° C. to give 6.62 g (60% yield), mp 199°-205° C. Analysis: Calculated for C 22 H 35 N 3 O 3 .2HCl: C, 57.14; H, 8.06; N, 9.09; Found: C, 57.25; H, 8.42; N, 9.07. EXAMPLE 29 5-[4-[4-(2-Hydroxyphenyl)-1-piperazinyl]butyl]-3-(1-methylethyl)-2-oxazolidinone hydrochloride (1:2). Following the procedure of Example 5, a mixture of 5-(4-chlorobutyl)-3-(1-methylethyl)-2-oxazolidinone (10.4 g, 0.0474 mol), 1-(2-hydroxyphenyl)piperazine dihydrobromide (16.12 g, 0.0474 mol), sodium bicarbonate (15.96 g, 0.190 mol) and potassium iodide (1.0) in n-butanol (350 mL) gave an oil. The oil was dissolved in absolute ethanol and acidified with ethanolic hydrogen chloride. Addition of ether and filtration gave a solid which was dried under high vacuum at 70° C. to give 9.47 g (46% yield), mp 203°-207° C. Analysis: Calculated for C 20 H 31 N 3 O 3 .2HCl: C, 55.30; H, 7.66; N, 9.67; Found: C, 54.97; H, 7.97; N, 9.49. TABLE I______________________________________Formula I Examples ##STR11##Examples Ar n R______________________________________ 1 C.sub.6 H.sub.5 4 CH.sub.3 2 2-pyridinyl 4 CH.sub.3 3 2-CH.sub.3 OC.sub.6 H.sub.4 4 CH.sub.3 4 2-pyrimidinyl 4 CH.sub.3 5 2-CH.sub.3 OC.sub.6 H.sub.4 3 CH.sub.3 6 2-pyridinyl 3 CH.sub.3 7 2-pyrimidinyl 3 CH.sub.3 8 2-C.sub.2 H.sub.5 OC.sub.6 H.sub.4 3 CH.sub.3 9 2-C.sub.2 H.sub.5 OC.sub.6 H.sub.4 4 CH.sub.310 2-HOC.sub.6 H.sub.4 3 CH.sub.311 2-HOC.sub.6 H.sub.4 4 CH.sub.312 2-(CH.sub.2CHCH.sub.2 O)C.sub.6 H.sub.4 4 CH.sub.313 2-CH.sub.3 OC.sub.6 H.sub.4 4 C.sub.6 H.sub. 514 2-pyridinyl 4 C.sub.6 H.sub.515 2-pyrimidinyl 4 C.sub.6 H.sub.516 C.sub.6 H.sub.5 4 C.sub.6 H.sub.517 2-HOC.sub.6 H.sub.4 4 C.sub.6 H.sub.518 2-C.sub.2 H.sub.5 OC.sub.6 H.sub.4 4 C.sub.6 H.sub.519 2-pyridinyl 3 C.sub.6 H.sub.520 2-pyrimidinyl 3 C.sub.6 H.sub.521 2-C.sub.2 H.sub.5 OC.sub.6 H.sub.4 3 C.sub.6 H.sub.522 C.sub.6 H.sub.5 3 C.sub.6 H.sub.523 2-CH.sub.3 OC.sub.6 H.sub.4 3 C.sub.6 H.sub.524 2-HOC.sub.6 H.sub.4 3 C.sub.6 H.sub.525 2-(CH.sub.2CHCH.sub.2 O)C.sub.6 H.sub.4 4 C.sub.6 H.sub.526 2-(CH.sub.2CHCH.sub.2 O)C.sub.6 H.sub.4 3 C.sub.6 H.sub.527 2-CH.sub.3 OC.sub.6 H.sub.4 4 CH(CH.sub.3).sub.228 2-C.sub.2 H.sub.5 OC.sub.6 H.sub.4 4 CH(CH.sub.3).sub.229 2-HOC.sub.6 H.sub.4 4 CH(CH.sub.3).sub. 2______________________________________ PHARMACOLOGY Anxiolytic test data obtained (competitive binding to 5HT 1A receptors or expiratory light/dark behavior) for the invention compounds and a reference compound are shown in Table II. TABLE II______________________________________Pharmacology DataEx- Light/ample 5HT.sub.1A.sup.1 Dark.sup.2 Example 5HT.sub.1A Light/Dark.sup.2______________________________________1 59 56 (10) 16 8.2 --2 61 53 (3.16) 17 15 --3 15 53 (3.16) 18 2.0 --4 190 -- 19 57 --5 29 -- 20 170 --6 110 -- 21 18 --7 510 -- 22 50 --8 22 -- 23 11 --9 16 -- 24 -- --10 110 -- 25 -- --11 40 -- 26 -- --12 20 66 (1) 27 -- --13 2.2 -- 28 -- --14 7.7 -- 29 -- --15 29 -- Buspirone 13.2 (avg) 51 (5.62) IP 54 (5.62) PO______________________________________ .sup.1 IC.sub.50 (nMol) .sup.2 % time spent in lit area (dose, mg/kg IP), minimum effective dose PHARMACEUTICAL COMPOSITION The pharmaceutical compositions used in the methods of this invention for administration to living animals are comprised of, as active ingredients, at least one of the compounds of Formula I according to this invention, in association with a pharmaceutical carrier or excipient. The compounds are thus presented in a therapeutic composition for oral, parenteral, or rectal administration. Thus for example, compositions for oral administration can take the form of elixirs, capsules, tablets or coated tablets containing carriers conveniently used in the pharmaceutical art. Suitable tableting excipients include lactose, potato and maize starches, talc, gelatin, stearic and silicic acids, magnesium stearate and polyvinyl pyrrolidones. For parenteral administration, the carrier or excipient can be comprised of a sterile parenterally acceptable liquid, e.g., water or arachis oil contained in ampoules. In compositions for rectal administration, the carrier can be comprised of a suppository base, e.g., cocoa butter or a glyceride. Advantageously, the compositions are formulated as dosage units, each unit being adapted to supply a fixed dose of active ingredients. Tablets, coated tablets, capsules, ampoules and suppositories are examples of preferred dosage forms according to the invention. It is only necessary that the active ingredient constitute an effective amount; i.e., such that a suitable dosage will be consistent with the dosage form employed in single or multiple unit doses. The exact individual dosages, as well as daily dosages, will, of course, be determined according to standard medical principles under the direction of a physician or veterinarian. Generally, the pharmacology tests suggest a contemplated effective oral dose for humans will be in the range of 2-200 mg daily to be taken in divided doses of from 0.5 to 50 mg 3 to 4 times daily.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a device for the self-application of hair treatment media from a hand-held container in which the media is stored. It comprises a fixed or rotatable applicator head mounted on the container and a dispensing mouth at least partially surrounded by bristles and one or more guide tines. 2. Statement of Related Art In the dyeing or other treatment of hair on the head, it is important to coat the hair regions disposed near the scalp uniformly with the hair-treating medium. An appropriate hair dyeing appliance is described in German patent document 27 49 074. The known hair dyeing device possesses a hollow comb element which consists of a tube with hollow tines inserted radially therein. The tube is connected, subject to interposition of a pressure reducing valve, with the container holding the dyeing medium. Bristles, which project beyond the tines at the end face, i.e. at their free ends, are arranged around each tine. A hair-dyeing device with a brush supplied by the dyeing medium is disclosed in European patent document 38,024. The brush spine of the known applicator device can be inclined through 45° to the longitudinal axis of the supply container. The applicator device disclosed in this European application possesses a comb separate from the brush supplied by the dyeing medium. Especially when intended for self-application, difficulties are presented when using the above-mentioned devices in uniformly treating the hairs on the top of the head, at the sides of the head and at the rear head region. Special hair-dyeing devices are also known for the dyeing of individual hair strands of often only a few hairs, such as described in German Utility Model (Gebrauchsmuster-GM) 79 32 856. This appliance possesses a comb-like applicator provided with a channel connected through a hollow comb spine with the interior of the container and two guide or comb tines, which are each arranged parallel to each other and between which, in the region near to the comb spine, is provided an opening communicating with the channel provided therein. To facilitate the application process, the longitudinal axis of each guide tine is arranged substantially perpendicularly to the plane formed by the longitudinal axis of the comb spine and the longitudinal axis of the container. In order to make possible an adapted setting of the tines for lefthanded or righthanded persons, it should be possible to assume two detent positions, each displaced relative to the other through 180° (about the comb spine as axis), each time for both guide tines in common. The known construction however does not permit further adjustment without appreciable demands on the abstracting capability of the operating person, because two mutually inclined rotary couplings might, in a given case, need to be reset at the same time. In the comb part known from the above utility model, bristles combined with the guide tines are not provided. Rather, it is proposed to subdivide the guide tines for the finer division of the hair strands respectively to be treated so that three or more tines arranged parallel to each other are present. BRIEF DESCRIPTION OF THE INVENTION Other than in the operating examples, or where otherwise indicated, all numbers expressing quantities of ingredients or reaction conditions used herein are to be understood as modified in all instances by the term "about". This invention is based on the task of creating a hair treating system which puts the user in the position with maximum effect to treat as little hair as possible and which also in the case of self application permits a uniform delivery of the hair treating medium as well as a facilitated manipulation at all sides of the head inclusive of the rear head region. For a hair treating device of the initially discussed kind with a hollow comb spine displaying two guide tines and with an exit opening at the comb spine between the guide tines, the solution according to the invention comprises placing in the region between the guide tines and immediately around the exit opening, bristles extending substantially parallel to the longitudinal direction of the guide tines. The bristles are placed at the body of the comb spine and the guide tines protrude beyond the free longitudinal ends of the bristles. Through the inventive placement of the bristles immediately around the media-conducting channel outlet, a medium flow is attained which is substantially independent of the size of the exit opening or of the channel cross-section. This construction secures a uniform delivery of the hair treating medium due to the valve-like braking effect of the bristles. The metering is therefore determined mainly only by the pump (capillary) action of the bristles on application or by pressure exerted on the container, which should then be flexible. Understood under the term "bristles" are also tufts of bristles. The bristles should end at or before the free longitudinal ends of the guide tines (in the region between the guide tines). Preferably the bristles end before the guide tines, most preferably by a distance of about 2 millimeters. A basic idea of such an arrangement is to let as many hairs as possible stay "natural" and thereby to make application of the treatment medium worth trying even by such persons as have reservations against a complete change of their hair color because of feared hair damage. In a further inventive embodiment, the comb spine is a component of an applicator head which may be mounted rotatably or fixedly on a container at the mouth thereof and which is tapered in the direction toward the guide tines. The applicator head can be added to a product package as a plug or the like. Basically, an applicator system according to the invention with guide tines and bristle crown arranged therebetween, can be placed on the opening of any desired applicator bottle. When a rotatable applicator head is used in combination with a container, the base of the applicator head should be circular in shape and adjoin a circularly shaped lid surface of the container, which surface preferably is inclined through 45° to the main container vertical axis. At the same time, it can be advantageous to set the rotational axis of the applicator aid into the center normal passing at the same time through the center of the container lid area as well as the base of the applicator aid. In a given case, it is favorable to orient the guide tines inclined through 45° to the rotational axis of the applicator head in such a manner that the longitudinal direction of the guide tines stands parallel to the longitudinal container axis in one rotational setting of the applicator head and perpendicular to the longitudinal container axis in a rotational setting pivoted through 180°. By a rotation through 180° about the rotational axis of the applicator head, the guide tines and thereby the guide slot spanned between them can then be pivoted through 90°, i.e. out of the parallel into the perpendicular (and conversely), to the main axis of the container serving as appliance handle. According to a further embodiment, the applicator head may have substantially the shape of an inclined circular cone with its cone tip lying perpendicularly above the cone base circumference with respect to the cone base area and with a cone height equal to the cone base diameter. The guide tines are then disposed in the region of the cone tip which is preferably rounded off for reasons of safety and stability, wherein a slot opening containing the bristles extends between the tines. For convenient and safe usage, and above all to prevent snagging of the hair, it is also important to round off all edges and corners of the guide tines and of the adjoining appliance parts; in particular, all molded edges should be chamfered or rounded. Due to the compact and rounded arrangement caused by a straight or inclined conical shape, a strand of hairs can be introduced conveniently into the slot between the guide tines which can be guided down to the hair root through reciprocating movement, while not treating adjacent strands, thus achieving a desired highlighting effect if a hair dye is dispensed. The inventive device may be constructed of any suitable plastic material, optionally with metal components. The nature of the plastic material does not constitute a part of this invention. In another preferred embodiment, an applicator head constructed as an inclined circular cone, adjoins a circularly shaped lid area of the container, the area being inclined through 45° to the main axis of the container, and the rotational axis of the applicator head lies in the center normal passing at the same time through the center of the container lid area as well as of the cone base. In this manner, a hair treating device is created having a closure which is placed rotatably at an angle of about 45° on the oval container body of elliptical shape at least adjoining the container mouth. The exit opening disposed between the guide tines at the base of the opening slot can be rotated through an angle of about 90° relative to the main container axis so that the respectively most favorable orientation of the guide tines relative to the main container axis, either steplessly or in detented settings, can be preset during the treatment for each treatment region at the side surfaces, the upper side and the rear side of the head. Particular mention must be made that the primary purpose of the inventive device is the application of hair dye, coloring, or bleaching agents, particularly hair dye. However, other hair treatment media, such as bleaches, tints, setting lotions, curling or straightening lotions, and the like, may also be utilized. BRIEF DESCRIPTION OF THE DRAWING Details of the invention are explained by reference to the accompanying drawing, all figures being related to embodiments of this invention. FIG. 1 is a longitudinal section through a hair applicator and container according to the invention. FIG. 2 is a cross section through the container of the device according to FIG. 1. FIG. 3 is an outside view of the container belonging to the hair treating device according to FIG. 1. FIG. 4 is an outside view of the entire hair treating device according to FIG. 1. FIG. 5 is an outside view of a hair-treating device according to FIG. 4 with applicator head pivoted through 90°. FIG. 6 is a cross section through an embodiment of an applicator head differing from FIG. 1. FIG. 7 is a cross section through an applicator head with an adapter. FIG. 8 is an outside view of the applicator head according to FIG. 7. FIG. 9 is a cross section through the applicator head according to FIG. 7 and turned through 90°. FIG. 10 is an outside view of FIG. 9, seen from the right in the drawing, of the applicator aid according to FIG. 9. DETAILED DESCRIPTION OF THE INVENTION In the following examples the hair treating device according to the invention is illustrated in different arrangement combined with media containers of different shape. The system according to the invention is however not limited to certain shapes of container or to certain relative angular settings. The hair treating device according to FIGS. 1 and 2 and globally designated by 1 comprises an oval cylindrical container 2 with base 3 and circularly shaped lid area 5 inclined through an angle (a) of 45° to the main vertical axis 4 of the container 2. In the illustrated embodiment, the ratio of the larger elliptical semi-axis R to the smaller elliptical semi-axis r is 1:sin 45°. An exit hole 6 is disposed in the lid area 5. This is surrounded by a nipple 7 on the outside of the lid area 5. The longitudinal axis 8 of the nipple 7 is inclined through an angle (a) of 45° to the main axis 4 of the container body 2. The applicator head which is globally designated by 11, in the embodiment according to FIGS. 1 to 5 possesses substantially the shape of an inclined circular cone with a motional cone tip 14 lying perpendicularly above the circumferential line 12 of the cone base 13 and with cone height H being equal to the cone base diameter D (see FIG. 5). The center line passing through the center 9 of the circular lid area 5 of the container 2 coincides with the normal (center line) in the center 15 of the cone base 13 and thereby with the longitudinal axis 8 of the nipple 7. Given the above stated presumptions, the inclined circular cone, describing substantial parts of the surface of the applicator head, according to FIGS. 1 to 5 possesses a shortest generatrix 16 of the length of the height H and a longest generatrix 17 between the cone tip 14 and the cone base circumference 12. For the stated angular and length relationships, the ratio of the length S of the longest generatrix 17 to the length H=D of the shortest generatrix 16 is 1:sin 45°. The applicator head 11 according to FIGS. 1 to 5 possesses a slot opening 18, which extends parallel to the longest generatrix 17 and perpendicular to the area spanned by the cone base 15 and the longest cone generatrix 17, at the exit opening 19. Communicating between this and the cone base surface 15 is a product channel 20, which preferably has the shape of an inclined hollow cone. The product channel 20 narrows in the direction of a straight outlet channel 21, which extends parallel to the longest cone generatrix 17, up to the exit opening 19. Beyond that, a receiving nipple 22 for the force-locking (click-fit) coupling of the nipple 7 of the container 2 is provided in the interior of the applicator aid 11, so that a locking rotation means is afforded. External views of a hair treating device 1 are illustrated in FIGS. 3 to 5. In the view according to FIG. 3, the lid area 5, which is inclined through 45° to the vertical axis 4 of the container body 2, yet circularly shaped when viewed perpendicularly, with nipple 7 is illustrated before the applicator head 11 has been placed on it. According to FIG. 4, the applicator head 11 can be so rotated about its longitudinal axis 8 that the longest generatrix 17 forms a straight continuation of the adjoining generatrix of the container body 2 (parallel to the main axis 4 of the container). Two slot surfaces 23 of the guide tines 24 and 25 bound the slot opening 18 and then extend likewise in a direction parallel to the vertical axis 4 of the container 2. When the applicator head 11 is pivoted through 180° about the axis 8 according to FIG. 5, the slot surfaces 23, bounding the slot opening 18, of the guide tines 24 and 25 are moved into a direction perpendicular to the main axis 4 of the container body 2. In use, the applicator head 11 can through rotation by up to 180° about the axis 8 be pivoted out of the parallel into the perpendicular to the vertical axis 4 of the container 2. Since the container 2 itself forms the handle of the dyeing appliance 1, a convenient manipulation at all places of the head is thus assured on use of the device according to the invention. A very significant feature of the invention is that the bristles 26, end within the slot opening 18, and thus are shorter than the guide tines 25 and 24. The bristles 26 are arranged around the exit opening 9 in the slot opening 18 remaining between the guide tines 24 and 25. The bristles 26 shall normally, i.e. without loading, stand about parallel to the slot surfaces 23 and to the longitudinal direction of the guide tines 24 and 25. They serve to even out the dye or other media application and to improve the metering. In the drawing according to FIG. 1, the notional part of the cone tip 14 of the applicator aid 11 is illustrated in dashed lines. As mentioned previously, for reasons of stability and safety, it is adviseable to shorten the cone in this region about transversely to the longest generatrix 17 so that the guide tines 24 and 25 are constructed as walls at both sides of the slot opening 18 affording them a stability adequate for the guidance of the hair to be dyed or otherwise treated. FIG. 6 shows an example of an embodiment of an applicator head 11 with a body of about circular cone shape in the lower region and in a certain sense a distally projecting cone tip 14' bent over about parallel to a generatrix. A product channel 20, leading to the interior of the rotatably attached container 2, with exit opening 19 again opens into this cone tip. The exit opening 19 is disposed between both of the guide tines 24 and 25 and is surrounded by bristles 26. Values of about 9 millimeters×8 millimeters×12 millimeters have proven useful for the respective length×width×height as dimensions of the guide tines 24 and 25. The width preferably narrows to about 4 millimeters in the upper (outer) third. In the rotary setting of the applicator head 11 according to FIG. 6, the guide tines 24 and 25 and the slot opening 18 disposed therebetween are evidently oriented about parallel to the main axis 4 of the container 2 and a generatrix, adjoining the applicator head 11, of the container 2. When the applicator head 11 is pivoted through 180° C. about its longitudinal axis 8, the guide tines 24 and 25 are moved out of the parallel setting to the main axis 4 into a setting perpendicular to the main axis 4. The manipulation and the details for the remainder agree substantially with the description of the hair treating device 1 according to FIGS. 1 to 5. In the embodiment according to FIGS. 7 and 10, an adapter 28 is placed between the applicator head 11 according to the invention and the container 2. It is constructed on its side facing the applicator head substantially just as the container 2 according to FIG. 1 and on its side facing the container 2 can possess a thread 29 for threading onto the mouth 30 of the container 2. The connection between container 2 and adapter 28 can also be structured in different manner, such as a click-fit. It is significant that on the use of the adapter 20, the requirement of elliptical container cross section in the rotational region of the applicator head 11 is removed. Instead, a container 2 of any desired cross section can be used in the embodiment according to FIGS. 7 to 10. The connection means between applicator head 11 and adapter 28 can, for example, be formed by the illustrated impact coupling 31. The structure according to FIGS. 7 to 10 can, basically just as the hair treating devices according to FIGS. 1 to 6, be equipped with a stopper 32, which after the filling of the container 2 is placed as closure on the mouth 30 thereof. For completion, the adapter 28 with applicator head 11 fastened thereon can then be threaded onto the closed container 2. On application, the consumer screws off the adapter 28 with applicator 11, removes the stopper 32 and sets adapter and applicator head again onto the mouth 30 of the container 2 so that the hair treating device 1 according to the invention is ready for operation. After use of the device, the stopper 32 can again be set as closure onto the mouth 23 in reversed sequence of the manipulations. In still another embodiment (not shown) the invention device may have a non-rotatable (i.e. fixed) applicator head, which is integrally formed with the adapter 28. In such instance, the bristles 26 and tines 24, 25 may be permanently mounted parallel to the container vertical axis 4 and would have the same outward appearance as shown in FIG. 8, as well as in the outline of FIG. 7. While the media flow channel of FIG. 7 could still exist, there would be no need for either a rotation means or opposed faces of the adapter and applicator head, since they would be integrally formed. The internal structure of such a non-rotatable applicator head/adapter combination will be readily apparent to those skilled in the art. Alternatively, the bristle 26/tines 24, 25 arrangement may be permanently perpendicular to the vertical axis 4, in which instance the outward appearance would be the same as in FIG. 10, as well as in the outline of FIG. 9. The foregoing comments regarding the parallel aligned arrangement are otherwise applicable.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention involves a tray assembly for wheel chairs, and, more particularly, a tray assembly which is removably attached to and supported by a conventional wheel chair where the tray position is horizontally, vertically and rotationally adjustable. 2. Description of the Prior Art Certain mountings have been previously invented to support trays upon wheel chairs. U.S. Pat. Nos. 4,705,287; 4,779,884; and 4,878,685 provide recent examples of the prior art. The previous tray assemblies for wheel chairs have certain limitations in use. What is needed is a universal tray assembly for wheel chairs which has the following characteristics: a. Supporting post or posts may be installed within wheel chair frame openings or externally clamped upon the wheel chair frame. b. The tray may be supported from either the right or left side of the wheel chair; when maximum support is required, the tray may utilize support from both sides of the wheel chair. c. The tray swings horizontally out of the way. d. The tray is vertically adjustable. e. Various sizes of trays may be used f. Tray positions are adjustable both front-to-rear and side-to-side, as well as being rotationally adjustable about a horizontal axis. g. The tray assembly is self-storing without disconnection from the wheel chair. SUMMARY OF THE INVENTION The present invention provides a tray assembly for wheel chairs which is designed to meet the aforementioned needs. A tray assembly is utilized which incorporates a pair of trays, capable of relative planar movement, which are rotatingly mounted upon a horizontal support member which is, in turn, rotatable about the vertical axis of a vertical support member mounted upon the wheel chair. Accordingly, in the preferred embodiment, a tubular vertical mounting post may be fixed within a vertical wheel chair frame opening, as available in many conventional wheel chairs, utilizing a stem connecting member. Alternatively, a tubular vertical mounting post may be externally clamped to the frame of the wheel chair. A tubular vertical support member, which telescopically fits about the mounting post, is clamped to the mounting post, said clamping being readily releasable by a user to permit both vertical adjustment of the vertical support member as well as rotation about its vertical axis, the latter permitting the tray to be horizontally swung out of a normal central location by the user. A horizontal support member is attached at the upper end of the vertical support member, the preferred embodiment utilizing a tray support member in the form of a 90-degree tubular elbow as a single structure with vertical and horizontal support members. A tray mounting plate is attached at the horizontal support member by clamping means which also are readily releasable, so as to permit the tray mounting plate to rotate about the horizontal axis of the horizontal support member. This rotational capability permits the tray mounting plate, and thus a tray, to be tilted to an inclined position as desired. One or more fixed horizontal or inclined positions may be provided as an alternative to the continuous clamping means. A first tray, or undertray, may be slidingly attached to the tray mounting plate by means of a pair of parallel, horizontally grooved members, affixed to the underside of the first tray, which engage opposing edges of the tray mounting plate. Preferably the horizontally grooved members are positioned to engage the side edges of the tray mounting plate so as to permit fore and aft movement of the first tray, although side to-side movement of the first tray may be used if desired. A second tray, or overtray may be similarly attached to the first tray, so as to allow the second tray to move orthogonally to the movement of the first tray. Thus, in the preferred embodiment, the second tray is adjustable from side-to-side upon the first tray, which, in turn, is adjustable forward and backward upon the tray mounting plate, providing four-direction adjustability of the second tray upon the tray mounting plate. The tray assembly may be supported by mounting posts installed on either the right or left side of the wheel chair as desired. When maximum support is required, support from both sides of the wheel chair may be used, utilizing a second mounting post and vertical and horizontal support members. The second horizontal support member is attached by means of a retracting bolt to the first horizontal support member at the tray mounting plate. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a side view of a wheel chair with a tray assembly for wheel chairs mounted thereon in a horizontal position. FIG. 2 illustrates a front view of the wheel chair of FIG. 1 with a tray assembly for wheel chairs shown in a vertical, off-to-the-side, storage position, and in a horizontal, in-use, position in dashed lines. FIG. 3 illustrates diagrammatically the various freedoms of movement of the tray assembly which are available to the user. FIG. 4 illustrates a partially sectioned side elevation view of the tray assembly for wheel chairs. FIG. 5 illustrates a sectional view, as seen at line 5--5 of FIG. 4. FIG. 6 illustrates a sectional view, as seen at line 6--6 of FIG. 4. FIG. 7 illustrates a sectional view, as seen at line 7--7 of FIG. 4. FIG. 8 illustrates a sectional view of a clamp, as seen at line 8--8 of FIG. 4 FIG. 9 illustrates an end view of the stem, as seen at line 9--9 of FIG. 4. FIG. 10 illustrates a side view of a wheel chair with a tray assembly mounted by an alternative means to the wheel chair. FIG. 11 illustrates a front view of the alternative mounting means of FIG. 10, as seen at line 11--11 of FIG. 10. FIG. 12 illustrates a sectional view, as seen at line 12--12 of FIG. 11. FIG. 13 illustrates a front view of the tray assembly utilizing dual mounting means. FIG. 14 illustrates a sectional view, as seen at line 14--14 of FIG. 13. DESCRIPTION OF THE PREFERRED EMBODIMENT Turning now to the drawings, there is shown in FIG. 1 a side view of a wheel chair 10 with a tray assembly 11 mounted thereon in a normal in-use position 12. FIG. 2 is a front view of the wheel chair 10 and tray assembly 11 showing the tray assembly 11 rotated to an out-of-the-way storage position 13 with the normal in-use position 12 shown in dashed lines. The tray assembly 11 is mounted utilizing a front vertical tubular frame member 14 of the wheel chair 10 whose upper end opening 15 is or may be exposed. A stem connecting member 16 is inserted within the opening 15 and locked into position. The stem connecting member 16 preferably is formed of three sections of tubing, an upper section 17 having an angled lower end 18, a middle section 19, having an angled upper end 20 and an angled lower end 21, and a lower section 22 having an angled upper end 23. The angled ends 18, 20 and 21, 23 which will, upon tightening, abut each other, are preferably angled equally at approximately 45-degrees. A nut 24 is fixed at the lower end 25 of the lower section 22. While welding of nut 24 to the lower end 25 of the lower section 22 is satisfactory, a preferred means of attaching the nut 24, as seen at FIG. 9, is by forming slots 26 in the lower end 25 of lower section 22, inserting the nut 24 so that its corners 27 extend within the slots 26 to prevent rotation of the nut 24, and then crimping the prongs 28 inward to hold the nut 24 in position. An elongated bolt 29, threaded at least at its lower portion 30, is supported at the upper end 31 of the upper section 17 and extends downward to engage the nut 24 at the lower end 25 of the lower section 22. As the bolt 29 is tightened, the angled upper end 23 of the lower section 22 and the angled lower end 21 of the middle section 19 will attempt to slide by each other, thereby increasing a transverse dimension 32 thereat. If the lower end 33 of the stem connecting member 16 is inserted into the opening 15 of a front vertical tubular frame member 14, subsequent tightening of the bolt 29 will effectively lock the lower end 33 of the stem connecting member 16 at a fixed position within the tubular frame member 14. A similar fixing occurs when a tubular mounting post 34 is placed over the upper end 35 of the stem connecting member 16, wherein tightening increases a transverse dimension 36 so as to wedge the lower end 18 of the upper section 17 and the upper end 20 of the middle section 19 into a fixed position. It has been found advantageous to form the upper end 20 and lower end 21 of the middle section 19 in generally parallel planes, such orientation providing a tighter, more secure locking action. When the lower end 33 of the stem connecting member 16 is inserted within the wheel chair 10 frame member 14 and a tubular mounting post 34 is slipped over the upper end 35 of the stem connecting member 16, upon tightening the bolt 29, the lower end 33 of the stem connecting member 16 is fixed to the wheel chair 10, and the tubular mounting post 34 is fixed concentrically about the stem connecting member 16. A predetermined position for the stem connecting member 16 within the wheel chair 10 frame member 14 is obtained by limiting the depth to which an untightened stem connecting member 16 may be inserted. This may be simply done by inserting a spring clip 37 into an accommodating groove 38 formed about the middle section 19 of the stem connecting member 16, the spring clip 37 abutting the upper end opening 15 of the frame member 14 upon insertion. A preferred mounting post 34 will enclose the upper end 35 of the stem connecting member 16 except for the head 39 of the bolt 29, it being desired that the bolt head 39 be exposed to facilitate tightening and loosening of the stem connecting member 16. For those wheel chairs 10A where an open front vertical tubular frame member 14 is not available for insertion of the above described stem connecting member 16, an alternative means of mounting 40 may be required. One such alternative means of mounting 40, as best seen in FIGS. 10-12, utilizes two clamping members 41 which are designed to clampingly engage vertically-spaced, horizontal wheel chair 10A frame members 42 and 43 in conjunction with an encircling band member 44 about a mounting post 45 which is oriented vertically. Preferably, each clamping member 41 and band member 44 combination are tightened by a common bolt 46, whereby the bolt 46 itself provides a mechanical link between the horizontal frame members 42, 43 and the vertical tubular mounting post 45. It should be noted that in FIGS. 1 and 2 the stem connecting member 16 means of mounting is at the left side of the wheel chair 10 while in FIG. 10, the alternative means of mounting 40 is attached at the right side. Either side of the wheel chair 10, 10A is available for mounting of the tray assembly 11, as the user desires. A suitable means of vertical tubular mounting having been achieved, with either a stem connecting member 16 having been installed with tubular mounting post 34 locked in place, or tubular mounting post 45 having been clamped in position, the remainder of the tray assembly 11 for wheel chairs 10 may be installed. FIG. 4, for illustrative purposes, shows the use of tubular mounting post 34 fixed on stem connecting member 16, it being clear that tubular mounting post 45, fixed to the wheel chair 10 by clamping members 41, is interchangeable with tubular mounting post 34 in the subsequent description. A tray support member 47 includes a vertical support member 48 and a horizontal support member 56. The vertical support member 48 has an inside diameter which is slightly greater than the outside diameter of the tubular mounting post 34, so as to allow the lower end 49 of the vertical support member 48 to snugly fit thereabout while permitting both rotational 92 and vertical 91 movement of the vertical support member 48 upon the tubular mounting post 34. The lower end 49 of the vertical support member 48 is formed with longitudinal slots 51 so as to provide, in combination with an encircling clamp 52, means for locking the vertical support member 48 in a fixed position upon the mounting post 34. The preferred clamp 52 is a split band 53, formed of a smooth resilient material such as nylon, which is tightened or loosened by the rotation of a camming lever 54. The tightening of clamp 52 compresses the slotted lower end 49 of the vertical support member 48 about the tubular mounting post 34 at the height and rotational position desired. When the clamp 52 is loosened, the vertical support member 48 may be rotated 360-degrees about its vertical axis 55 upon the tubular mounting post 34 or may be adjusted vertically from a position wherein the lower end 49 of the vertical support member 48 abuts the vertical tubular frame member 14 of the wheel chair 10 to a position where the vertical support member 48 is physically lifted off the mounting post 34. A horizontal support member 56 joins the upper end 50 of the vertical support member 48, extending at a right angle thereto. While the horizontal support member 56 and the vertical support member 48 may be separate members appropriately joined to form a tray support member 47, the preferred structure is to use a 90-degree tubular elbow 57. The horizontal support member 56 is rotatingly attached to a tray mounting plate 58 by means of two encircling members, a tray mount block 59 and a tray clamp block 60. The tray mount block 59, preferably formed of nylon, is fixedly attached to the tray mounting plate 58 and supported by the horizontal support member 56. The tray clamp block 60, in the form of an encircling clamp member 61 also is fixedly attached to the tray mounting plate 58 to permit rotation of the tray mounting plate 58 about the axis 62 of the horizontal support member 56. The clamp member 61, as seen at FIG. 6, is of similar construction to the clamp 52 wherein a split band 63 is tightened or released by rotation of camming lever 64. The clamp member 61, provides encircling support at the end 65 of the horizontal support member 56. The tray mounting plate 58 is fixed at a longitudinal position upon the horizontal support member 56 by stops 66 located on the inward sides of the tray mount block 59 and the tray clamp block 60. Stop 66 may be provided by a spring clip 67 engaging an accommodating groove 68 in the horizontal support member 56, as shown in FIG. 4. Continuous rotational positioning of the tray mounting plate 58 about the horizontal axis 62 of the horizontal support member 56 may be obtained by means of the clamp member 61. Alternatively, several specific rotational locations may be utilized wherein, in lieu of a spring clip 67 located to the inside of the tray mount block 59, a lock collar 69, fixed on the horizontal support member 56, as by a set screw 70, may include one or more apertures 71 about its periphery which are formed to engage a pin 73 inserted through an aperture 74 in the tray mount block 59, each aperture 71 location corresponding to a predetermined tray angle. In the preferred embodiment, collar 69 apertures 71, in combination with tray mount block 59 aperture 74, are located so as to correspond to a level tray mounting plate 58 and to a 30degree-tray inclination (not shown), respectively, have been found to work well, although additional apertures 71 for different angles also may be desired. A first tray or undertray 75 is formed to engage the tray mounting plate 58 so as to provide a linearly variable position of the undertray 75 relative to the tray mounting plate 58 Such linearly variable positioning may be obtained by utilizing undertray tracks 76 of generally U-shaped cross section which are affixed to the bottom 77 of the undertray 75 with the longitudinal openings 78 facing inwards and spaced so as to slidingly engage the tray mounting plate 58 on opposing sides 79, 80. In the preferred embodiment of the undertray 75, the undertray tracks 76 are positioned to allow front to back linear movement 94, that is, forward away from or back towards a seated user. A preferred undertray 75 is formed of 1/8-inch thick tempered hardboard with a length of 14 inches and a width of 117/8-inches and is flat so as to receive an overtray 81, as described below. A second tray or overtray 81 may be provided which slidingly engages upon the undertray 75 so as to provide linear movement in a direction perpendicular to the direction of movement of the undertray 75 upon the tray mounting plate 58. This is achieved through the attachment of U-shaped overtray tracks 82 upon the bottom 83 of the overtray 81, with the longitudinal openings 84 of the U-shaped tracks 82 facing inwards towards the smaller undertray 75 thereby slidingly engaging the undertray 75 on opposing sides 85, 86 to allow linear side-to-side movement 95 of the overtray 81 upon the undertray 75. The preferred undertray tracks 76 and overtray tracks 82 are made of resilient plastic which is formed to pinch or grasp the tray mounting plate 58 and undertray 75 respectively. An excellent, readily available, track 76, 82 material is the cap mold which is applied to protect and seal the edges of shower boards. The form of the overtray 81 may take various shapes. Currently preferred are a larger flat table-like sheet of 1/8-inch tempered hardboard (not shown), or, alternatively, a dinner-type tray 87, conventionally approximately 20-×15-inches with an outer edge 88 extending upwardly approximately one-inch. Generally the overtray 81 will be removable from the undertray 75 by continuing its linear movement 95 until the overtray tracks 82 become disengaged. However, it generally is preferable for the undertray 75 to be retained upon the tray mounting plate 58, this being accomplished by one or more stops 89 formed on the bottom 77 of the undertray 75 which limit linear movement past the undertray tracks 76. The stops 89 may be formed of the same U-shaped material as the undertray tracks 76, so that, at a limiting position, a stop 89 also will assist in supporting the undertray 75. As best seen in FIG. 3, the tray assembly 11 for wheel chairs 10, provides wheel chair trays 75, 81 which have multiple potential positions so as to provide the user with both maximum flexibility and convenience. The position of the tray support member 47 and thus tray mounting plate 58 may be adjusted vertically 91 at, and rotated 92 about, the mounting post 34 attached to the wheel chair 10. Additionally, the tray mounting plate 58 may be rotated 93 about the horizontal axis 62 of the horizontal support member 56. The combination of rotations 92 and 93 allows the tray mounting plate 58, and attached undertray 75, to be located in front of a seated user for use, or may be rotated out of the way to a vertical side position 13 which is convenient for storage, as seen at FIGS. 2 and 9. Front-to-back linear movement 94 is available to vary the position of the undertray 75 upon the tray mounting plate 58, to allow the undertray 75 to be adjusted closer or further away from the seated user. If the overtray 81 is used, side-to-side linear movement 95 also is available. Of course, as a result of rotational movement 92, the undertray 75 and/or overtray 81 simply may be rotated horizontally completely out of the way from in front of the seated user. It also is possible, by rotation 92 and linear movement 94, to position the undertray 75 to the side of the user. While the tray assembly 11 is designed for support by a first mounting structure 97, e.g., single mounting post 34 or 45 and tray support member 47, it may be desirable, if additional sturdiness is required, to provide a second mounting structure 98, thereby forming a U-shaped support 96 extending from the wheel chair 10 as shown in FIG. 12. Where a second mounting structure 98 is used, the mounting means to the wheel chair 10 is merely duplicated on the other side, e.g., use of the other open front vertical tubular frame member 14 or the alternative frame mounting 40, as described above. Since the position of the second mounting structure 98 normally is fixed in relationship to the wheel chair 10, it is necessary to provide means for attachment of the second mounting structure 98 to the horizontal support member 56 of the first mounting structure 97. This is accomplished by providing an interior bolt 99, in the form of a cylinder, at the end 65 of the horizontal support member 56, which has two positions: a retracted position wherein the bolt 99 does not extend from the end 65 of the horizontal support member 56, and an extended, supporting position wherein the bolt 99 extends to within the horizontal end 100 of a second horizontal support member 101, which is part of the second mounting structure 98, to provide the connecting means by which the second mounting structure 98 provides support. Thus, in the process of engaging the second mounting structure 98, the bolt 99 is retracted within the end 65 of the first mounting structure 97, the retracted position, as seen in FIG. 4, preferably being the normal single-support position, and the horizontal end 100 of the second horizontal support member 101 is moved to be aligned with and abut the end 65 of the first horizontal support member 56, at which time the bolt 99 is extended outwardly to engage the end 100 of the second horizontal support member 101 and locked into position. Locking is achieved by a pin 102, attached to the bolt 99, which extends through and is guided within a U-shaped slot 103 in the horizontal support member 56 as best seen at FIG. 13. Preferably the second horizontal support member 101 engages the first horizontal support member 56 at either the tray mount block 59 or the tray clamp block 60, so that the bolt 99 directly transfers weight from the tray mounting plate 58 to the second mounting structure 98. Additionally, it is clear that the tray assembly 11 may also be mounted on structures other than wheel chairs 10, such as beds, where the advantages of multiple tray positions would also be available. It is thought that the tray assembly 11 for wheel chairs of the present invention and its many attendant advantages will be understood from the foregoing description and that it will be apparent that various changes may be made in form, construction and arrangement of the parts thereof without departing from the spirit and scope of the invention or sacrificing all of its material advantages, the forms hereinbefore stated being merely exemplary embodiments thereof.

1a

This is a continuation of U.S. Ser. No. 08/291,187, filed Aug. 16, 1994, now U.S. Pat. No. 5,415,165, which is a continuation of U.S. Ser. No. 08/145,034, filed Oct. 29, 1993, now abandoned, which is a continuation of U.S. Ser. No. 07/994,721, filed Dec. 22, 1992, which is a continuation of U.S. Ser. No. 07/719,098, filed Jun. 20, 1991, now U.S. Pat. No. 5,174,290, which is a continuation of U.S. Ser. No. 07/496,186, filed Mar. 20, 1990, which is a continuation of U.S. Ser. No. 07/380,704, filed Jul. 13, 1989, which is a continuation of U.S. Ser. No. 07/237,286, filed Aug. 26, 1988; and a continuation-in-part of U.S. Ser. No. 07/719,097, filed Jun. 20, 1991, and a continuation-in-part of U.S. Ser. No. 07/892,631, filed Jun. 2, 1992, now U.S. Pat. No. 5,186,172; and a continuation-in-part of U.S. Ser. No. 07/513,026, filed Apr. 24, 1990, which is a continuation of U.S. Ser. No. 07/237,288, filed Aug. 26, 1988, which is a continuation-in-part of U.S. Ser. No. 07/233,888, filed Aug. 17, 1988, now abandoned, which is a continuation of U.S. Ser. No. 07/120,720, filed Nov. 6, 1987, which is a continuation of U.S. Ser. No. 07/013,552, filed Feb. 11, 1987, which is a continuation of U.S. Ser. No. 06/833,287, filed Feb. 27,1986, now U.S. Pat. No. 4,643,192, which is a continuation of U.S. Ser. No. 06/360,718, filed Mar. 22, 1982, now abandoned. BACKGROUND AND SUMMARY OF THE INVENTION This invention relates to medical diagnostic equipment and methods and is particularly concerned with hollow viscus tonometry and remote electronic and optical sensing. The prior art (see U.S. Pat. No. 4,643,192) has recognized that intestinal ischemia, and to a lesser degree, stress ulceration, are two problems that plague physicians involved in the management of patients in intensive care units. Intestinal ischemia, in particular, has an insidious onset and may not be detected until days after the intestine has become completely and irreversibly compromised. A delay in the diagnosis of intestinal ischemia may have devastating consequences for a patient. The availability of means for early diagnosis and management of patients with these problems would have immediate applicability in all intensive care units, especially where the procedure can be conveniently conducted with reasonable safety and reliability. It has been established that a fall in the intramucosal pH may precede the development of intestinal ischemia and stress ulceration. As I reported in my prior U.S. Pat. No. 4,643,192, expressly incorporated herein by reference, entitled "Hollow Viscus Tonometry" a fall in intramucosal pH also occurs within minutes of inducing intestinal ischemia in dogs. The fall in pH in intestinal mucosa, and hence the likelihood of ischemia or stress ulceration, can be reliably calculated from a pCO 2 (partial pressure of CO 2 ), or other indicia of pH, in luminal fluid and the bicarbonate concentration in arterial blood. The method of calculating the pH in intestinal mucosal tissue, pursuant to principles of my prior patent, has been validated by directed measurements under a variety of conditions simulating clinical problems. A correlation coefficient in the order of 0.92 to 0.95 has been obtained in each of 16 dogs. The validity of the procedure is inherently extensible to humans, and indeed may also be useful in assessing the vitality of other hollow organs and tissue. See R. G. Fiddian-Green et al. "Splanchnic Ischemia and Multiple Organ Failure". To measure the pCO 2 in the lumen of the gut it has heretofore been necessary to obtain and remove a sample of fluid that has been in contact with the wall of the gut for a certain time period, usually at least half an hour. It has now been observed that it is somewhat difficult to manually aspirate the sampling fluid or medium from a tonometric catheter located in the gut or other internal focus with any consistency. It is much easier to obtain such samples from the stomach, but samples obtained from the stomach frequently contain foreign material that can damage a gas analyzer. As taught in my prior patent, the desired sample or samples can be obtained from the gut using a catheter tube (called a tonometric catheter) having a walled sampling chamber on the tube with the sampling chamber being in sample-specific communication with the hollow interior of the tube. The wall of the sampling chamber comprises a material which is substantially impermeable to liquid yet is highly permeable to gas. One suitable material is polydimethylsiloxane elastomer. In use the catheter is introduced into a patient to place the sampling chamber at a desired site within the gut. An aspirating liquid or medium is employed to fill the interior of the sampling chamber. The sampling chamber is left in place at the desired sampling site long enough to allow the gases present to diffuse through the wall of the sampling chamber into the aspirating liquid. The time should be long enough for the gases to equilibrate. The liquid impermeable nature of the sample chamber wall material prevents both the aspirating liquid from leaking out of the chamber and also the intrusion of any liquids into the aspirating liquid. After the appropriate or desired amount of placement time has elapsed the aspirating liquid is aspirated along with the gases which have diffused into it. The sample thus obtained is analyzed for gas content, in particular for pCO 2 . In this way the pCO 2 within the lumen of the gut can be reliably measured with the fluid being free from lumenal debris. In carrying out the diagnostic method taught in my prior patent the pCO 2 measurement is utilized in conjunction with a measurement of the bicarbonate ion concentration (HCO 3 - ) in an arterial blood sample of the patient for determining the pH of the tract wall. Depending upon the particular condition of a given patient, the catheter may be left in place and samples may be taken at periodic intervals so that pH values may be periodically calculated. The procedure has a high reliability in accurately determining the adequacy of organ tissue oxygenation, and diagnosing intestinal ischemia in its incipient stages. Such determination or detection can be useful in treating the patient so that the potentially devastating consequences resulting from less timely detection may often be avoided. While the sampling techniques taught in my prior patent have provided highly accurate and reliable results, it has now been observed that there are instances (in the care of the critically ill in intensive care units, for example) in which remote sensing of the organ or organ-wall condition and automatic calculation of the organ or organ-wall pH would be advantageous and easier to effectuate. This method would thus partially or totally eliminate the need for the somewhat cumbersome aspiration of the sampling fluid or medium which fills the sampling chamber; it may also eliminate the need for the sampling chamber to be in sampling-medium communication with any other part of the device. There is also a need to extend the benefits of tonometric sampling and sensing to other internal hollow viscous organs. To this end, there is a need for new and different tonometric devices specifically adapted to allow my sensing and sampling techniques to be performed with ease in a clinical environment, and in combination with other procedures. The importance and significance of determining the pH of the wall of a given hollow viscus organ has been recently dramatically magnified as a result of the recent recognition that the pH of the wall of a given organ can be employed to accurately evaluate the vitality and/or stability of that organ as well as others; this is in contrast to merely determining whether such an organ is experiencing an ischemic event. Further, certain organs can be selected for monitoring, either alone or in combination, and evaluation of this organ or these organs can aid in predicting the overall condition of the patient, or the onset of a multitude of pathologies, including predicting or identifying such events as multiple organ failure. Such a methodology can be employed to greatly enhance and supplement the monitoring of the critically ill, for example. In one aspect, the present invention provides a new apparatus and method for remotely sensing organ condition and conveying an electromagnetic signal, e.g. an electrical current or optical signal, to an electronic or optical apparatus located outside the organ under investigation. In one embodiment, a chemically sensitive electronic transducer (or plurality of transducers), such as a field effect transistor, is attached to a tonometric catheter for introduction into the organ along with the tonometric catheter. The first electronic sensor, preferably non-temperature, generates and conveys an electromagnetic signal indicative of some desired aspect of organ condition, e.g., indicative of the pCO 2 , pH and/or pO 2 level of the organ or organ-wall. For example, in one preferred embodiment, mean ambient pCO 2 , pH and/or pO 2 of lumenal fluid or the like is measured or monitored via wire or other suitable electromagnetic energy conveying means to an electronic circuit which interprets the electromagnetic signal and produces a report of the organ condition. The electronic circuit may include an input for receiving a separately determined signal indicative of the blood pH of the patient. Using this pCO 2 , pH and/or pO 2 measurement along with blood (preferably arterial) pH data, the electronic circuit determines the pH of the organ wall under test and thereby provides information for determining the organ's current condition or perhaps predicting the organ's future condition. The electronic circuit may be suitably constructed from analog components, digital components or both. In another embodiment, a pH, pCO 2 or pO 2 sensitive colorimetric substance is injected into an area adjacent to the organ, e.g., into the sampling chamber of the tonometric catheter, and an optical sensor is employed to detect color change in order to determine the pH of the wall of that organ. The optical sensor can either be disposed in or on the tonometric catheter for introduction into the area adjacent the organ or it may be disposed outside the organ with fiber optic cable optically coupling the sensor to the tonometric catheter site at which the pH sensitive substance has been injected. In another aspect the present invention provides a variety of new and different tonometric catheter devices for sensing and/or sampling a fluid or gas property (such as pH, pO 2 , pCO 2 , and the like) which is indicative of the condition of an internal organ, in conjunction or combination with a walled catheter tube adapted for delivery or draining fluids, such as nasogastric tubes, urinary catheters, ureteric catheters, intestinal feeding tubes, wound or abdominal drains (suction or regular) and biliary tubes, catheters and stents, with or without remote sensing means for pH, pCO 2 and/or pO 2 . In still another aspect or embodiment, the device employs two separate walled catheter tubes, one tonometric catheter tube for the measurement of a fluid or gas property, that is in communication with the sampling chamber; and a second walled catheter tube adapted for delivering or draining fluids. In yet another aspect or embodiment, the device employs a walled sampling chamber in communication with a sensing means, and a second walled catheter tube adapted for delivering or draining fluids. Optionally, when a non-temperature sensing-means is employed, a second sensing-means may be employed as well. For a more complete understanding of the invention, its objects and advantages, reference may be had to the following specification and to the accompanying drawings. Also, see my co-pending and commonly assigned applications filed of even date herewith entitled "Remote Sensing Tonometric Catheter Apparatus and Method" and "Hollow Viscus and Solid Organ Tonometry", bearing respective U.S. Ser. No. 237,286 filed Aug. 26, 1988 (now abandoned), and U.S. Ser. No. 237,288, filed Aug. 26, 1988 (now abandoned). both of which are totally and expressly incorporated herein by reference. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a first embodiment of the tonometric catheter; FIG. 2A is a partial cross-sectional view of the tonometric catheter illustrating a first means for attachment of an electronic field effect transistor sensor; FIG. 2B is a partial cross-sectional view of the tonometric catheter illustrating a second means of attachment of the field effect transistor sensor; FIG. 3 illustrates the method of use of the tonometric catheter in measurement of the pH of the colon and also of the stomach, the specific embodiment illustrated for colonic measurement being that of FIG. 5 and the specific tonometric catheter for gastric measurement being that of FIG. 4; FIG. 4 is another embodiment of the tonometric catheter with nasogastric tube; FIG. 4A is a cross-sectional view of the tonometric catheter of FIG. 4 taken substantially along the line 4A--4A of FIG. 4; FIG. 4B is a cross-sectional view of the tonometric catheter of FIG. 4 taken substantially along the line 4B--4B of FIG. 4; FIG. 5 is yet another embodiment of the tonometric catheter having multiple sensing/sampling portions; FIG. 5A is a cross-sectional view of the tonometric catheter of FIG. 5, taken substantially along the line 5A--5A of FIG. 5; FIG. 6 is a detailed view illustrating the tonometric catheter of FIG. 4 in use within the stomach; FIG. 7 is a detailed view illustrating the tonometric catheter of FIG. 5 in use within the colon; FIG. 8 is a similar view illustrating the tonometric catheter of FIG. 1 i n use within the colon; FIG. 9 is an electrical schematic diagram illustrating one embodiment of electronic circuit in accordance with the invention; FIG. 10 is an electrical schematic diagram illustrating another embodiment of the optical measurement of pH in accordance with the invention; FIG. 11 is another embodiment of a tonometric catheter with a urinary catheter; FIG. 11A is a cross-sectional view of the tonometric catheter/urinary catheter of FIG. 11, taken substantially along the line 11A--11A of FIG. 11. FIG. 12 illustrates one preferred example of the application of a tonometric catheter device according to the present invention, with remote sensing and recording apparatus for monitoring and recording certain critical fluid properties of interest. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 illustrates a first embodiment of tonometric catheter 20. The tonometric catheter comprises a length of suitable tubing 22, one end 32 of which is closed, and the opposite end of which has a connector such as a luer-lock 24. Luer-lock 24 is adapted to receive a complementary fitting 26, which in turn couples through a second length of tubing 28 to a three-way stopcock 30. Three-way stopcock 30 may be used to selectively connect tubing 28 to various sources of irrigation or aspiration. Adjacent the closed end 32, tubing 22 is perforated as at 34. A balloon-like tonometric catheter membrane 36 is fitted over the closed end so that the perforations 34 are enclosed, as illustrated. The tonometric catheter membrane 36 has an internal sleeve diameter at 38 which forms a tight fit with tubing 22. The preferred form of tonometric catheter membrane is polydimethylsiloxane elastomer. The membrane may be sealed to the tubing 22 with appropriate adhesive so that the tonometric catheter membrane is sealed in a closed relationship to the outer wall of tubing 22, thereby forming a sampling chamber 40 adjacent closed end 32. The tonometric catheter membrane has a certain elasticity to allow the membrane to expand when filled with an aspirating liquid in order to contact the wall of the organ under examination, as will be explained below. The membrane 36 is preferably constructed such that at least a portion of it is selectively permeable to the gas or fluid property of interest. In a preferred embodiment, it is selectively permeable to hydrogen, oxygen, or H + , so that pH, pCO 2 and/or pO 2 can be measured. It is also preferably impermeable to other materials that would interfere with the desired measurements, such as other gases, proteins, and the like. In a highly preferred embodiment, an ion-selective membrane is employed. Bonded to either the inner wall or the outer wall of tubing 22 are one or more sensors 42 for detecting a property indicative of pH and/or temperature. Two such sensors are illustrated in FIG. 1, bonded to the outside wall of tubing 22 with suitable adhesive. FIGS. 2A and 2B illustrate two alternate means of sensor attachment, FIG. 2A illustrating the sensor attached to the inner wall of tubing 22 and FIG. 2B illustrating the sensor attached to the outer wall of tubing 22. In a preferred embodiment, at least a portion of the tubing, but not all of it, is made of a CO 2 impermeable material, such as polyester elastomers derived from the reaction of dimethylterephtalate 1,4-butanediol and α-hydro-Ω-hydroxypoly (oxytetramethylene). In a highly preferred embodiment, this is a material such as Hytril, sold by DuPont. For purposes of sensing temperature, thermistor devices are presently preferred. For sensing properties indicative of pH chemically responsive field effect transistors or "Chemfets" may be employed. In this regard, Chemfet sensors 44 have been illustrated in FIGS. 2A and 2B. Chemfet sensor 44 comprises a field effect semiconductor device 46, which is encapsulated in a solution impervious material 48, such as a polymerized epoxy resin. The encapsulation material 48 in turn may be encapsulated in a housing 50 (FIG. 2A). Semiconductor device 46 is electrically coupled by bonding wires 52 to a terminal 54. Suitable electrical conductors such as conductor 56 are attached to terminal 54 for electrically communicating between the Chemfet device 44 and the electronic circuitry described below in connection with FIG. 9. Conductor 56 is preferably routed through tubing 22 and exits through a sealed aperture at or near the luer-lock end of tubing 22, as at 58. A more detailed description of a suitable electronic sensor may be found in U.S. Pat. No. 4,020,830 to Johnson, entitled "Selective Chemical Sensitive FET Transducers," incorporated herein by reference. In order to allow a solution to contact the chemically sensitive surface of semiconductor device 46, tubing 22 may be provided with an aperture 60 when implementing the embodiment of FIG. 2A. Such an aperture is not needed in the embodiment of FIG. 2B, since the semiconductor device 46 is exposed to sampling chamber 40 by virtue of the external mounting configuration. The sampling chamber 40 can be filled with an aspiration or sampling medium that is used to absorb or otherwise provide a means for incorporating and delivering or measuring the the fluids or gases of interest. Such a medium is selected depending upon many factors, including the properties of the fluids or gases of interest, the type of sensor 42 employed, and the type of calibration that is necessary. Such mediums include bicarbonate solutions and saline solution. It might be noted that gases often behave as fluids and are therefore frequently considered to be fluids. As noted above, when the sensor employed does not require frequent recalibration, the need for the sampling chamber 40 to be in communication with the proximate end of the tonometric catheter (that remains outside the patient) may be eliminated since no aspiration is needed. However, in many instances such communication may still be desirable as aspiration may be required to calibrate the sensor or sensors, to replace the aspirating or sampling medium with a fresh medium, and to incorporate the gas or gases of interest. Another embodiment of the tonometric catheter is illustrated in FIGS. 4, 4A and 4B. As illustrated, the tonometric catheter is appropriately configured to also serve as a nasogastric sump, either with or without gastric suction. With reference to FIG. 4, the tonometric catheter 20a comprises a multipassage tubing 62 which defines three individual noncommunicating (between each other) passageways or lumens, an air lumen 64, an optional suction lumen 66 and a tonometric catheter lumen 68. A tonometric catheter membrane, similar to that previously described, is attached at an intermediate location on tubing 62, allowing a portion of the tubing to extend beyond the end of membrane 36 to define the nasogastric sump 70. Tubing 62 is provided with a plurality of perforations 72 which communicate between tonometric catheter lumen 68 and the sampling chamber 40 defined by membrane 36, If desired, one or more sensors 42 can be included in accordance with the above teachings, in which case a suitable conductor 56 may be routed through tonometric catheter lumen 68 to exit at sealed aperture 58. The nasogastric sump portion 70 is suitably provided with a plurality of openings 74 through which the stomach may be aspirated. At the opposite end of tubing 62 the tubing splits to form three separate connections. Air lumen 64 communicates with air lumen passageway 76, suction lumen connects with suction lumen passageway 78 and tonometric catheter lumen 68 communicates with tonometric catheter lumen passageway 80. The tonometric catheter lumen passageway is fitted with three-way stopcock 30, similar in function and purpose to the three-way stopcock 30 described in connection with FIG. 1. If desired, a quick connect fitting 82 may be used to couple the suction lumen passageway 78 with an aspiration source. As illustrated, the quick connect fitting preferably has angularly cut ends and a slightly enlarged midsection, making it easy to insert into the end of passageway 78 and also into the aspiration hose coupling (not shown). The enlarged midsection helps form a seal with the adjoining passageways. Preferably the quick connect fitting is fabricated of disposable plastic. Yet another embodiment of the tonometric catheter is illustrated in FIGS. 5 and 5A. This embodiment is a multiple tonometric catheter embodiment employing a tubing 84 having a plurality of passageways or lumen as shown in the cross-sectional view of FIG. 5A. Specifically, tubing 84 includes an air lumen 86a which communicates with the endmost tonometric catheter 36a and three additional tonometric catheter lumens 86b, 86c and 86d, which communicate respectively with tonometric catheters 36b, 36c and 36d. As with the other embodiments, each tonometric catheter may be provided with one or more sensors such as sensors 42. A radiopaque tungsten plug 88 is positioned within each of the three tonometric catheter lumen 86b, 86c and 86d adjacent the distal end of each tonometric catheter, serving to block the remainder of the tonometric catheter lumen passageway and thereby ensuring that fluid pressure introduced into each tonometric catheter lumen will cause the associated tonometric catheter to balloon outwardly as required during use. Similarly, a radiopaque tungsten rod 90 is fitted as a plug in the end of air lumen 86a, serving to terminate the end of the air lumen passageway. Being radiopaque, the tungsten plugs and tungsten rod aid in properly positioning the tonometric catheters by being visible under fluoroscope or x-ray. In addition, if desired, tubing 84 can be provided with a radiopaque stripe along all or part of its length. At the proximal end of tubing 84 the lumen 86a-86d diverge to define four separate tubes 92a-92d. Each tube is fitted with a three-way stopcock similar to those described above. Each sampling connector may optionally be coded numerically by color, etc. While four approximately equally spaced tonometric catheters have been illustrated in FIG. 5, it will be understood that the invention can be modified to include a greater or fewer number of tonometric catheters at different spacing as required for a particular application. It will also be understood that some or all of the tonometric catheters can include one or more sensors coupled to conductors 56, each preferably routed through the corresponding lumen passageway. Referring now to FIG. 9, a suitable electronic monitoring circuit will now be described. In FIG. 9 CHEMFET semiconductor device 46 has been shown schematically by the equivalent circuit model enclosed in dotted lines. The device 46 thus comprises drain electrode 150, source electrode 152 and reference electrode 154. The chemically selective system, such as a membrane system is depicted diagrammatically at 156. The substrate is grounded as at 158. Source electrode 154 is coupled to an input lead of operational amplifier 160 which includes feedback network diagrammatically depicted at 162. Operational amplifier 160 senses the drain source current flowing through device 46 and converts this signal into a voltage signal which is output on lead 164. The drain source current changes in accordance with changes in the chemical system under test. More specifically, as the pCO 2 level changes in the fluid exposed to device 46, the drain source current changes accordingly. Hence the output voltage signal on lead 164 is likewise an indication of the pCO 2 level of the organ under test. This voltage signal on lead 164 is coupled to an input of comparator 166 which also receives a reference voltage V ref , which may be supplied using a voltage divider network (not shown) or which may alternatively be provided by a digitally controlled voltage source 168. The output of comparator 166 is fed to reference electrode 154 to provide a stable reference bias voltage. If a digitally controlled voltage source is used, this reference voltage can be adjusted and calibrated by a computer circuit yet to be discussed. The voltage signal on lead 164 is also fed to an analog to digital convertor 170, which is in turn coupled to a microprocessor-based microcomputer 172. In order to automatically determine the pH of the wall of the hollow viscous organ under test, a separate gas analyzer sensor 174 is used to determine the bicarbonate concentration in the arterial blood of the patient. The output of sensor 174 is coupled through analog to digital convertor 176 to microcomputer 172. Microcomputer 172 is preprogrammed to calculate the pH of the organ wall using the values provided by analog to digital convertors 170 and 176. Conversion of pCO 2 measurements can be converted into pH measurements automatically by microcomputer 172 using various equations and references well-known in the art. Although many different types of output devices may be employed, strip chart recorder 178 and CRT monitor 180 have been illustrated. Strip chart recorder 178 and monitor 180 are coupled as output devices to microcomputer 172. Strip chart recorder 178 offers the advantage of developing an easily readable, permanent record of the fluctuations in organ wall pH. Monitor 180 offers the advantage of providing digital readout of the pH value as well as displaying the upper and lower excursions of pH fluctuation. If desired, microcomputer 172 can be preprogrammed using keyboard 182 to compare the instantaneous pH value with doctor-selected upper and lower alarm limits. If the measured instantaneous pH fluctuates outside those limits, microcomputer 172 can sound an alarm to alert hospital staff. While a single semiconductor device 46 has been illustrated in conjunction with the electronic circuit of FIG. 9, the circuit may be readily adapted for use with a plurality of semiconductor devices in order to measure the pH at different locations substantially simultaneously. In such an embodiment, the data coming from each sensor can be fed to a separate I/0 port of microcomputer 172. In the alternative, a single I/0 port can be used with the individual input signals being time multiplexed. As an alternative to electronic pH sensors, the invention may also be practiced using optical sensor technology. Referring to FIG. 10, the presently preferred optical sensor embodiment uses a first fiber optic cable 94 which is optically coupled through a series of lenses 96, selectable color filters 98 and heat absorber 100 to an illumination source 102, such as a 100 watt tungsten-halogen lamp. Fiber optic cable 94 is routed through the tonometric catheter lumen in a fashion similar to the conductor 56 of the above-described embodiments, with the end thereof protruding through the tubing and into the sampling chamber 40. A second fiber optic cable 104 is routed parallel to the first fiber optic cable 94, with one end protruding through the tubing and held in place adjacent the end of first cable 94 with a collar 106. Collar 106 may be adhesively bonded to the outside wall of the tubing. The opposite end of second fiber optic cable 104 is positioned for optically coupling with a phototransistor 108 which is electrically connected to an operational amplifier circuit 110. The operational amplifier circuit can be coupled to an analog to digital converter, such as A/D converter 170 of FIG. 7. In use, fiber optic cable 94 illuminates a region within the sampling chamber 40 which is filled with a sampling fluid containing a colorimetric pH indicator, The illumination from fiber optic cable 94 reflects from the molecules suspended in the pH indicator solution, with some of the reflected illumination passing back through second fiber optic cable 104 to the phototransistor. By selecting the appropriate filter 98, a monochromatic illumination or illumination of otherwise known spectral content is employed to illuminate the colorimetric pH indicator solution. When the color of the filtered illumination matches that of the indicator, the illumination is absorbed and a low illumination signal is received at the phototransistor. When a pH change causes a color change in the indicator away from the color of the filtered illumination, more illumination is reflected back to the phototransistor, with an attendant increase in detected signal output. In this fashion, the proper selection of indicator dye and illumination filtration can be used to detect pH ranges. For a further description of fiber optic pH sensor technology, refer to G. G. Vurek "A Fiber Optic pCO 2 Sensor," Annals of Biomedical Engineering, Vol. 11, pp. 499-510, 1983, which is available from Pergamon Press, Ltd., and is expressly incorporated herein by reference. While the preferred embodiments have been disclosed in connection with monitoring of the gastrointestinal tract and the urinary and ureteric tracts it will be appreciated that its principles are applicable to other hollow internal organs to monitor pH and hence perfusion of those organs. Also while several presently preferred detailed constructions for tonometric catheters have been disclosed, it will be appreciated that other constructions may be developed which are equally suitable. The disclosed constructions are presently preferred for the reason that they are readily fabricated using existing available materials. Other embodiments may include other, but equivalent materials for the tonometric catheter membrane and/or connective tubing. They may also differ in the specific fabrication details. As an example, the sampling chamber may be eccentric rather than symmetric about the connective tubing. In still another embodiment, conventional gas analyzers may be employed externally. A device such as that shown in FIG. 1 may be used in combination with a pump or aspiration means (not shown) for continuous or regular intermittent aspiration of a sample of the aspirating liquid or medium that is used to fill the sampling chamber 40. The sample removed by pump or aspiration means via attachment to the luer-lock 24 can be optionally designed so that the sample aspirated at each sampling interval can be brought in contact with an exterior, separate gas analyzing means or sensor (not shown) to determine the pH, pO 2 , pCO 2 and/or the like, of the sample. Such automatic sampling can be conducted employing a system as shown in FIG. 12. In the assembly a sampling system employs a personal computer to conduct evaluations and analysis of the samples withdrawn from the tonometric catheter 299. Pump 203 is loaded with the sampling or aspirating medium such as saline. Next, valve 201 is activated to withdraw a desired amount of the sampling fluid. The valve 201 is deactivated and pump 203 is used to enforce the sampling chamber of the tonometric catheter 299 using a calibrated amount or optionally a pressure transducer 215. The sampling fluid or medium is allowed to come to equilibrium with the wall of the organ or area of interest. Next the "dead space," i.e., the area of the lumen filled with the sampling fluid that is not in equilibrium, is removed by activating valve 205, activating pump 207, activating valve 209 and infusing pump 207; the waste 219 is discarded. A sample for analysis is then withdrawn by deactivating valve 209, activating pump 207 to then deliver the sampling to a gas analyzer (not shown) that provides data from the sample to the PC 217, and the evaluation is conducted as described herein. The sample gas analyzer or a separate gas analyzer may be employed to determine the bicarbonate concentration in the arterial blood of the patient, as described above. Another embodiment of the tonometric catheter is illustrated in FIGS. 11 and 11A. As illustrated, the tonometric catheter is appropriately configured to also serve as a urinary or ureteric catheter, either with or without suction, which optionally employs sensors. With reference to FIGS. 11 and 11A, the tonometric catheter 220 comprises a multipassage tubing 262 which defines three individual noncommunicating (between each other) passageways or lumens, an optional air or irrigation lumen 264, a drainage or suction lumen 266 and a tonometric catheter lumen 268. A tonometric catheter membrane, similar to that previously described, is attached at a distal location on tubing 262, allowing an intermediate portion of the tubing not extending beyond the end of membrane 236 to define the uretary or uretary catheter 270. Tubing 262 is provided with a plurality of perforations 272 which communicate between tonometric catheter lumen 268 and the sampling chamber 240 defined by membrane 236. If desired, one or more sensors 242 can be included in accordance with the above teachings, in which case a suitable conductor 256 may be routed through tonometric catheter lumen 268 to exit at sealed aperture 258. The urinary catheter or ureteric catheter portion 270 is suitably provided with a plurality of openings 274 through which the bladder or ureters may be aspirated or irrigated. At the opposite end of tubing 262 the tubing splits to form three separate connections. Air or irrigation lumen 264 optionally communicates with air lumen passageway 276, urinary lumen connects with suction or drainage lumen passageway 278 and tonometric catheter lumen 268 communicates with tonometric catheter lumen passageway 280. The tonometric catheter lumen passageway is fitted with three-way stopcock 230, similar in function and purpose to the three-way stopcock 30 described in connection with FIG. 1. If desired, a quick connect fitting 82 as seen in FIG. 4 may be used to couple the suction urinary passageway 278 with an aspiration source. As illustrated, the quick connect fitting preferably has angularly cut ends and a slightly enlarged midsection, making it easy to insert into the end of passageway 278 and also into the aspiration hose coupling (not shown). The enlarged midsection helps form a seal with the adjoining passageways. Preferably the quick connect fitting is fabricated of disposable plastic. Yet another embodiment of the urinary catheter/tonometric catheter combination illustrated in FIGS. 11 and 11A may employ a multiple tonometric catheter embodiment employing a tubing having a plurality of passageways or lumen as shown in the cross-sectional view of FIG. 5A. In another embodiment *of the present invention, a tonometric catheter may be adopted to deliver a pharmaceutically-active agent, either for systemic, local or topical activity, or a combination thereof. For example, an additional lumen may be added such as that and for irrigation or aspiration, to deliver the active. For example, the irrigation/aspiration lumen 264 shown in FIG. 11 and 11A, may be used to deliver an active agent. In another embodiment, a portion of the device may be modified so as to provide sustained release of the active agent of interest. Thus, for example, the problems of nosacomial infection associated with catheter insertion can be overcome by incorporating an antimicrobial into at least a portion of the polymeric material used to manufacture the tonometric catheter, or by coating at least a portion of the device with a sustained release composition, or by delivering the antimicrobial via the tonometric catheter. Such modifications are well known to those skilled in the art. See U.S. Pat. No. 4,677,143, incorporated herein by reference. Classes of useful agents include antimicrobial agents, nonsteroidal anti-inflammatory agents, topical anesthetics, topical vasodialators, metabolic suppressants, and other agents that could be delivered for absorption at the sites of the tonometric catheter. Accordingly, while several preferred embodiments of the invention have been disclosed, it will be appreciated that principle of the invention, a set forth in the following claims, are applicable to other embodiments.

1a

BACKGROUND OF THE INVENTION This invention relates to the field of pressure measurement. Specifically this invention relates to an improvement in an optical technique for pressure measurement used in the field of static and dynamic foot pressure distribution measurements. One prior art foot pressure measurement system is disclosed in R. P. Betts and T. Duckworth, "A Device for Measuring Plantar Pressures Under the Sole of the Foot," 7 Engineering in Medicine 223 (1978). As described therein, this system comprises a glass or transparent plate illuminated along two or more edges, with a thin sheet of reflective material on its upper surface, as shown in FIGS. 1 and 2. The light shining into the plate normally is internally reflected. The reflective material causes light to escape through the top and bottom surfaces of the glass plate when pressure is applied to the reflective material. The amount of light escaping is proportional to the applied pressure. Viewing the underside of the glass reveals the applied pressure distribution as a variation in light intensity. The variation of light intensity and hence pressure are conveyed to the observer by viewing the underside of the plate, either directly or using a mirror, with a monochrome television camera. In an alternative prior art embodiment, the reflected light is processed into color bands for a display on a color monitor, each band representing a specific pressure range. A significant advance in this art was made by capturing the light intensity data in a computer system. See. e.g., C. I. Franks, et al., "Microprocessor-based Image Processing System for Dynamic Foot Pressure Studies," Medical & Biological Engineering and Computing 566 (Sept. 1983). A typical configuration for such a system is shown in FIG. 3. In this system data from the video camera is converted into digital format by a microprocessor image capture and analysis system, and the data are stored in digital memory. This system enables the observer to playback the pressure distribution data from either a static or dynamic sequence of samples and to perform further analysis of the data. With the development of this system improved calibration techniques became possible and were implemented by measuring the total vertical force applied to the top surface of the plate each time light intensity distribution was measured using force transducers. This provided the necessary data with which to calibrate the light values in terms of applied pressures. The prior art systems depend on distinguishing background light levels from light levels caused by foot pressure by setting a threshold level, below which all light values are considered to be background light. As there is a certain amount of noise in the video data, and a degree of irregularity in the evenness of background light escaping from the glass plate, setting a threshold level can lead to loss of low levels of foot pressure data if the threshold level is set too high and erroneous data if the threshold level is set too low. SUMMARY OF THE INVENTION Accordingly, one object of the present invention is to provide an improved foot pressure measurement system with a variable background threshold level. Another object of the present invention is to provide an improved foot pressure measurement system in which background threshold levels may be made to correspond to each element of the scanned view of the light output. Another object of the present invention is to enable detection of lower pressure levels in a foot pressure measurement system than otherwise would be possible. A further object of the present invention is to eliminate or substantially reduce interference caused by variations in the amount of light escaping from the glass plate in a foot pressure measurement system. A still further object of the present invention is to eliminate or substantially reduce in a foot pressure measurement system the effect of increased or decreased light value levels escaping from the glass plate as a result of internally reflected images which may be seen through the underside thereof. Another object of the present invention is to compensate in a foot pressure measurement system for increased or decreased light levels escaping from the glass plate as a result of impurities within the glass. A further object of the present invention is to compensate for increased or decreased light values escaping from the glass plate in a foot pressure measurement system as a result of foreign objects within the glass. A still further object of the present invention is to capture and store in a foot pressure measurement system variable background threshold data immediately prior to capturing pressure data. Another object of the present invention is to reduce the effect on the emission of background light from the glass plate in a foot pressure measurement system caused by changes in ambient temperature. A further object of the present invention is to eliminate the effects of long term fluctuations in light intensity from glass plate 2 of a foot pressure measurement system. A further object of the present invention is to eliminate the effects of medium term fluctuations in light intensity from the glass plate of a foot pressure measurement system. Another object of the present invention is to eliminate calibration errors caused by variations in background light levels from the glass plate of a foot pressure measurement system. A still further object of the present invention is to enable effective run length encoding of data and hence reduced storage space requirements by eliminating background light levels in a foot pressure measurement system. Another object of the present invention is to provide an improved reflective material in a foot pressure measurement system. Briefly, in accordance with the preferred embodiment of this invention, the foregoing objects are achieved by providing an improved foot pressure measurement system in which a reference measurement is made of background light intensity and distribution before pressure is applied to the reflective material on the glass plate and this background light intensity is subtracted from the light levels when pressure is applied. A photographic paper is used as the reflective material on the top surface of the glass plate to improve the reflectance characteristics of the system. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a diagram of the optical portion of the prior art foot pressure measurement system which is incorporated in the present invention. FIG. 2 is an enlarged view of the reflective material-to-glass interface of the prior art foot pressure measurement system. FIG. 3 is a diagram of the prior art microprocessor-based dynamic foot pressure measurement system, with force transducers at the corners of the glass plate. FIGS. 4a-d are graphs of the light intensity versus applied pressure for various types of reflective materials. FIG. 5 is a block diagram of the microprocessor image capture and analysis system of the present invention. FIG. 6 is a flow chart showing data collection in the present invention. FIG. 7 is a flow chart showing background reduction and data encoding in the present invention. FIG. 8 is a flow chart showing data calibration and display in the present invention. FIG. 9 is an illustration of output foot pressure printout of the present invention showing some of the sequential frames of data. FIG. 10 is a flow chart of the control program's primary functions of the present invention. FIGS. 11a-b are flow charts of the data capture functions in the control program of the present invention. FIG. 12 is a flow chart of the display and analysis functions in the control program of the present invention. FIG. 13 is a flow chart of the analysis functions in the control program of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings wherein like referenced numbers designate identical or corresponding parts throughout the several views, FIG. 1 illustrates the optical portion of the prior art foot pressure measurement system incorporated in the present invention. In the preferred embodiment, glass plate 2 is made of Pilkington clear white plate glass, grade A, measuring approximately 22.5 inches by 19 inches by 1 inch. Other suitable materials are plexiglass and Dow Corning Pyrex. The surfaces and edges of glass plate 2 are ground flat and polished to ensure maximum transmission of light and to minimize spurious reflections. Conventional fluorescent strip lights 1 are mounted so as to allow light only to penetrate the edge of glass plate 2. The strip lights are mounted inside conventional reflectors 200. A sheet of reflective material 3 is positioned on the top surface of glass plate 2. A mirror 4 is positioned beneath glass plate at a 45° angle thereto. The lens of monochrome television camera 5 is focused on mirror 4 and is aimed along an axis parallel to the surface of glass plate 2. FIG. 2 illustrates the interface between glass plate 2 and reflective material 3. In FIG. 2a, no pressure is applied to this material. Because of the irregular surface of reflective material 3 there are numerous air gaps separating it from glass plate 2. Since air has a lower refractive index than glass, light passing through glass plate 2 from strip light 1 is internally reflected where air gaps exists between glass plate 2 and reflective material 3. Where reflective material 3 comes into intimate contact with glass plate 2, such as at point 201, internal reflection does not occur because reflective material 3 has a higher refractive index than glass. At these points of contact light is refracted out of the glass and scattered back in all directions from the surface of reflective material 3. A portion of the scattered light is reflected through the bottom surface of glass plate 2 to mirror 4 and into television camera 5. Referring to FIG. 2b, when pressure is applied to reflective material 3, such as by a person standing on the upper surface thereof, the deformable surface of this material is forced into more intimate contact with the upper surface of glass plate 2, the total area of such contact depending on the applied pressure. Output light intensity versus applied pressure for a variety of different reflective materials in shown in FIGS. 4a-d. In each curve the 25th, 50th, 75th and 100th percentile curves are shown for the corresponding reflective material. These percentiles refer to pixels having a light intensity at the specified percentile level. For example, the 75th percentile curve means that the pressure versus light intensity curve is for pixels having a sufficiently high light intensity that 75% of the total pixels have a lower light intensity while 25% have a higher light intensity. FIG. 4a illustrates the pressure versus light sensitivity curve for "Baromat" ridged surface silicone rubber manufactured by Biomechanics of La Mesa, Calif. FIG. 4b illustrates the pressure versus light sensitivity curve for white polyvinyl-chloride, trade named "Velbex" manufactured by Storeys Industrial Products, Ltd. FIG. 4c illustrates the pressure versus light sensitivity curve for natural latex rubber, grade "S" manufactured by Four D Rubber Co., Ltd. FIG. 4d illustrates the pressure versus light sensitivity curve for a resin coated photographic paper, trade named "Ilfospeed," No. MG.44M, medium weight pearl finish, manufactured by Ilford, S.A. Baromat, PVC plastic and natural latex rubber, as shown in FIGS. 4a-c, respectively, have been used in prior art foot pressure measurement systems. As these figures show, the pressure versus light intensity curves are nonlinear. Furthermore, in the case of PVC and natural latex rubber, the pressure versus light intensity curves exhibit hysteresis, i.e., the light intensity follows one curve when pressure is increased from zero to a specified maximum level and then follows a different curve as pressure is removed from the material. As shown in FIG. 4d, the resin coated photographic paper exhibits an essentially linear pressure versus light intensity curve and exhibits no hysteresis. This material also shows little viscoelasticity, tackiness or other hesteresis-like effects and exhibits no evidence of saturation over the pressure range studied. Referring again to FIG. 1, the upper surface of reflective material 3 is covered by an opaque material 6, such as a photographic dark room rubberized fabric. The preferred reflective material is resin coated photographic paper, such as the "Ilfospeed" photographic paper discussed in connection with FIG. 4, which should be "fixed" by the normal photographic developing process and placed white side down on the upper surface of glass plate 2. The same type of photographic paper is also manufactured by Kodak and is identified as "Poly Contrast" paper. An alternative reflective material is trade named "White Colour Card," 0.013 inch thickness, manufactured by Slater-Harrison. Referring to FIG. 3, glass plate 2 is mounted on force transducers 7 placed at each of the four corners thereof. These transducers measure the overall vertical force applied to glass plate 2, allowing a highly accurate calibration of the relationship between light levels and pressure. In an alternative embodiment, multi-component force transducers are used which also measure shear forces and torques applied to glass plate 2. This increases the versatility of the pressure measurement system of the present invention in some applications. The optical axis of camera 5 is parallel to glass plate 2. To reduce the overall height of the structure of this system, mirror 4 and camera 5 may be rotated as a unit so that the angle between mirror 4 and glass plate 2 is reduced to less than 45°. It is essential, however, that the angular relationship between mirror 4 and camera 5 remain constant to maintain the correct view of the underside of glass plate 2. For optimum results the entire structure shown in FIG. 1 (with the exception of the top surface of glass plate 2 which is already covered by reflective material 3, which is in turn covered by opaque material 6) is enclosed in a light proof assembly to exclude extraneous light from glass plate 2, mirror 4 and camera 5. Camera 5 may be positioned externally to the light-proof assembly, with provision made for the camera lens to view mirror 4 through an aperture in the light-proof assembly. Using the resin coated photographic paper as the reflective material 3 of the preferred embodiment, video camera 5 generates an output analog signal whose magnitude is directly proportional to the pressure exerted on this film. Referring again to FIG. 3, the output signal from monochrome TV camera 5 is input to microprocessor image capture and analysis ("MICA") system 8. MICA system 8 is shown in block diagram form in FIG. 5. Also input to MICA system 8 are the output signals generated by each of the force transducers 7. The video signal from video camera 5 is input to a conventional gain and clamp circuit 9, such as the combination of an Analog Devices Model No. AD711 operational amplifier (gain) and a Burr Brown Model No. SHC298 (sample and hold). Gain and clamp circuit 9 is controlled by a standard video offset control ("VOC") circuit 11, such as an Analog Devices Model No. AD558. CPU 23 provides data value to VOC 11, which is determined by integrating the digital video signal from a single frame from camera 5 and comparing this integrated light value to a preselected value. If the integrated light value exceeds the preselected value, VOC 11 increases the offset voltage fed to gain and clamp circuit 9; conversely, if the integrated light value is less than the preselected value, VOC 11 decreases the offset voltage fed to gain and clamp circuit 9. The output of gain and clamp circuit 9 is input to a conventional high-speed video analog to digital converter ("ADC") 10, such as a Micro Power Model No. MP7684. The operation of MICA system 8 is controlled by a conventional central processing unit ("CPU") 23, which may be an 8, 16 or 32 bit processor or any other device capable of being programmed and of providing control functions for the other components of the system. In the preferred embodiment CPU 23 is a Harris Model No. 80C88 microprocessor. CPU 23 passes and receives data to and from the other elements of the system via conventional CPU data bus 19. Similarly, device and memory addresses, control signals, requests and acknowledgements are transmitted between CPU 23 and the other system elements via CPU address and control bus 20. In the preferred embodiment, video ADC 10 converts the analog video signal for each pixel in video camera 5 into an 8 bit digital value. The digital output from video ADC 10 is fed onto a conventional video random access memory ("video RAM") bus 12, as described below, by means of a signal from CPU 23 on CPU address and control bus 20. The digital values produced by video ADC 10 are stored in a conventional video random access memory ("video RAM") 16, such as a Fujitsu Model No. MB 8146115. Data is input to video RAM 16 on video RAM bus 12 under control of a conventional video system controller 17, such as a Texas Instruments Model No. TMS 34061. Video RAM 16 can store 1,048,576 bytes, or 32 frames of video data, each of which measures 256 pixels by 128 pixels. Video system controller 17 provides video timing and synchronizing signals 18 for the video elements of the system, such as horizontal and vertical sync pulses and horizontal and vertical blanking pulses. The 8-bit digital values produced by video ADC 10 are also input to a conventional color lookup device 13, such as an Inmos Ltd. Model No. IMS G170S50, which converts these values into three analog values to drive the red, green and blue inputs 14 to a conventional analog color graphics monitor 15 such as an NEC Multisync. This produces a color-coded display of the pressure data seen by monochrome video camera 8. In this way the pressure values are grouped into bands of colors for easier recognition by the user of the present system. Color lookup device 13 is preset by CPU 23 to provide a selected range of colors at its output. It has 256,000 colors to choose from, of which a palette of 256 may be selected at any one time. For example, if the digital value 15 is input to color lookup device 13, the color light blue is generated, while if the digital value 30 is input, the color dark blue is generated. Video RAM 16 is dual-ported to allow simultaneous access to its data by video system controller 17 and CPU 23. In this way, CPU 23 may access the digitized video data while it is being input to video RAM 16. Programming information for CPU 23 is stored in a conventional 32 kilobyte random access memory 22 ("CPU RAM"), such as an NEC Model No. D43256C-12L. This memory contains the CPU control program and various constants such as values for color lookup device 13 and VOC 11. Referring again to FIG. 3, each of the force transducers 7 generates a voltage directly proportional to the force exerted on glass plate 2. As shown in FIG. 5, these signals are fed to a conventional analog to digital converter ("ADC") 24, such as Analog Devices Model No. AD7828, which converts these analog voltages into 8-bit digital format. The output of ADC 24 is fed to CPU RAM 22. In the preferred embodiment four force transducers are used so that four 8-bit digital channels are output from ADC 24. It should be understood, however, that a larger number of force transducers may be used in the instant invention. In the preferred embodiment control programs, described below are transferred from and data are transferred to and from a host computer 28, such as an IBM Model PC/AT, via a conventional parallel interface 26, such as an Advanced Micro Devices Model No. 82C55, communicating over bus 27. This provides flexibility in programming and operation of the system. In an alternative embodiment, the entire system of FIG. 5 is incorporated into host computer 28 itself. In another alternative embodiment the entire system of FIG. 5 (excluding host computer 28 and monitor 15) is incorporated in a single integrated circuit board, such as the True Vista Video Graphics board, Model AT Vista, made by True Vision, Inc. A conventional "bootstrap" program is stored in eight kilobytes of a conventional erasable programmable read-only memory ("EPROM") 21, such as an Hitachi HN27C64G-15, to enable system operation to begin. On "power up" the bootstrap program sends a reset pulse through the system to initialize all of the component elements. This program then directs CPU 23 to input or "download" the control program and certain system parameters, described below, from host computer 28 through parallel interface 26. In the preferred embodiment host computer 28 is programmed to calculate calibration values from the force and video data, as described below. CPU 23 may also be programmed to modify the video data, as described below. Host computer 28 interacts with CPU 23 providing it with information to display, via video RAM 16 and color lookup 13, on a conventional analog color monitor 15, such as an NEC "Multisync" monitor. Similarly, the initiation of data collection from both video ADC 10 and 8-bit ADC 24 may be ultimately controlled by host computer 28. Data collected by the instant pressure measurement system may be stored and further processed, if desired, by host computer 28. Operation of the system is explained by reference to the flowcharts in FIGS. 6-8. As shown by block 30 in FIG. 6, the system is initialized for data collection by the "bootstrap" program which downloads program instructions and constant data parameters, such as the video offset control parameters, color lookup parameters and video system controller parameters, from host computer 28. After initialization one frame of video data is input from monochrome television camera 5 to MicaSystem 8, prior to any pressure being applied to glass plate 2. This provides background level data for each pixel sample. A video frame in the instant system comprises a field of 128×256 pixels or 32,768 pixels per frame. The video signal for each pixel is converted by video ADC 10 into an 8-bit digital word and stored in video Ram 16, as shown by block 31 in FIG. 6. After the video background frame has been stored, the voltages generated by force transducers 7 are sampled and converted into 8-bit digital words by ADC 24. This data is stored in CPU RAM 22 as baseline data, as shown by block 32. The program then enters a loop wherein the next frame of video data is observed by video camera 5, digitized by video ADC 10 and stored in video RAM 16, as shown by block 33. The force transducer data from force transducers 57 are then sampled by ADC 24 during transmission of the first video frame, as shown in block 34. The video data stored in video RAM 16 is compared with the previously stored video data for the background frame by subtracting the digital value for each pixel in the background frame from the digital value for the corresponding pixel in the video frame. These differences are then summed. If the sum is greater than a specified threshold value, input from host computer 28, it is assumed that pressure has been applied to glass plate 2. Alternatively, the same type of comparison is made between the stored baseline reference level of force transducers 7 (block 32) with the new values for these transducers (block 34) and an increase in level above a specified threshold level indicates an increase in pressure applied to glass plate 2. Block 35 illustrates this step. This pixel-by-pixel comparison is carried out as pixel data for the current frame is read into video RAM 16 by means of the dual port in this device. If there is no change in pressure levels (either by comparing the background video frame against the current video frame or by comparing the baseline force transducer data against the current force transducer data), this process is reiterated. Thus, the next frame of video data is input to video RAM 16 and compared with the background frame, and the next corresponding set of force transducer data is input to CPU RAM 22 and compared with the baseline data. During this repetitive sequence the data in video RAM 16 for the current frame writes over the data for the preceding frame and the current force transducer data in CPU RAM 22 corresponding to the preceding frame writes over the force transducer data for the frame. If the comparison between the background frame and the current frame indicates a change in pressure level above the specified minimum, or if the comparison between the baseline force transducer data and the current force transducer data indicates a change in pressure level on glass plate 2, the system proceeds to the loop defined by blocks 36-38 in FIG. 6. The first step, as shown by block 36, is to sample and save the current video frame. This frame is stored in a separate location in video RAM 16. Similarly, the current set of force transducer data, as shown in block 37, is sampled and stored in a separate location in CPU RAM 22. The system then interrogates to determine whether video RAM 16 is full, i.e., whether it has stored 32 frames of video data, as shown by block 38. If video RAM 16 is not full, the system returns to block 36 and repeats this process for the next frame of video data and force transducer data. This process continues until video RAM 16 is full, i.e., it contains 32 frames of video data. Since a footstep typically does not last for the duration of all 32 frames, there will be one or more frames stored in video RAM 16 which contain only background data and one or more corresponding sets of force transducer data stored in CPU RAM 22 comprising baseline reference data. Referring now to FIG. 7, the background video frame, which previously had been used to determine initiation of a footstep and the first frame of video data stored in video RAM 16 containing foot pressure data are read by CPU 23 on a pixel-by-pixel basis, as shown in blocks 51 and 52. Each background video frame pixel is subtracted from the corresponding first frame pixel, as shown in block 53. This subtraction has the effect of reducing background levels to very low digital values, such as 1 or 2, depending on the short-term noise in the system. This step is followed by subtracting a constant value, such as digital 3, from each pixel value, as shown in block 54. If the resulting pixel value is negative, it is set to zero, as shown in block 55. As a result of this step, a zero pixel value indicates no pressure has been applied to the area in glass plate 2 corresponding to this pixel, while a non-zero pixel value indicates that pressure has been applied to this area. The constant value used in block 54 is then added back to the non-zero pixel values, as shown in block 56. The background-free video data is then written over the unmodified data in video RAM 16. The result of this process is that the background signal (corresponding to the absence of pressure from a footstep) is eliminated from the video signal on a pixel-by-pixel basis. The modified data in video RAM 16 may then be compressed, as shown at block 57, to reduce storage space requirements using standard data compression techniques. For example, because the background data has been set to zero, an effective method of data compression is to "run length encode" the data. Using this technique two numbers are used to represent a stream of constant values. The first number indicates the data value and the second number indicates how many times the data value is repeated. In this way, long streams of unchanging values are reduced to two data values for storage. For example, if one line of the video frame had foot pressure at locations on glass plate 2 corresponding to the first ten pixels of a particular video scan line and there was no foot pressure at locations corresponding to the remaining 118 pixels in that line, this data could be run length encoded by storing the numbers "0" and "118." The encoded data is then saved in CPU RAM 22, as shown by block 58. The program then checks to see if all stored frames have been processed, as shown in block 59. If additional frames must be processed, the system loops back to block 52 and the next video frame is read and compared with the background frame, in the same manner as above. If no further video frames are to be processed, the system exits to the series of steps illustrated in block diagram form in FIG. 8. Referring now to FIG. 8, the video data is calibrated in host computer 28 following the encoding process. The first frame of encoded data is read from CPU RAM 22 into host computer 28 through parallel interface 26, as represented by block 70. The light values are then integrated over the entire video frame, i.e., the digital values for all pixels are added together for the entire frame, as represented by block 71. The integrated value is then tested to determine if the frame contains any pressure data, as shown by block 72. If the integrated value is zero (indicating that the frame has no pressure data), the system skips to block 76, whose function is described below. If the integrated value is non-zero (indicating that the frame has pressure data), the frame data is calibrated. The calibration factor for a frame is calculated from the following equation, as represented in block 73: ##EQU1## where L i light value (0-255) for the "i"th pixel, N=number of pixels A P =pixel area F=total force on glass plate 2 C=calibration factor (same for all pixels) Pixel area is calculated from the geometrical relationship between the camera scan area and the dimensions of the viewed area of glass plate 2. It may be found by applying points of pressure at known separations on glass plate 6 and then identifying the corresponding pixels in the video output. For example, if pressure is applied to two points on glass plate 2, separated by ten inches and this pressure generates increased light values at pixels 20 and 120 on a particular scan line, the pixel separation equals 100 and adjacent pixels correspond to a 0.1 inch separation on glass plate 2. Force in the foregoing calibration equation is determined by adding the four digitized values for the output of force transducers 7 corresponding to the video frame being calibrated. As described above, this data is stored in CPU RAM 22. Every pixel for the particular frame being calibrated is then multiplied by the calibration factor, as shown by block 74. After the frame data has been calibrated it is fed to color lookup device 13, which generates an analog voltage corresponding to the calibrated digital value for each pixel. Since the pixel value is encoded in an eight-bit word, color lookup device 13 generates 256 different combinations of analog voltages on the "R" (red), "G" (green) and "B" (blue) output lines 14. The output of color lookup device 13 is fed on lines 14 to color monitor 15, which displays the video frame in color from a palette of 256 colors, as represented by block 75. Alternatively, as shown in FIG. 3, the output of color lookup device 13 may be fed to a printer 204, a plotter 205, or stored on a hard disk 202 or a diskette 205. An example of eight frames printed by printer 204 showing foot pressure at times 0.03, 0.10, 0.17, 0.23, 0.30, 0.37, 0.43 and 0.50 seconds are shown, respectively, in FIGS. 9a-h. As shown in FIG. 9a, the foot begins exerting pressure at the heel. Pressure then is applied to the ball of the foot (FIGS. 9b-d). As pressure is removed from the heel, it begins to be applied to the smaller toes (FIGS. 9e-f) and finally is applied to the large toe (FIGS. 9g-h). Referring again to FIG. 8, the system interrogates to determine whether all frames have been displayed, as shown by block 76. If additional frames remain to be displayed the system loops back to block 70 and performs the same sequence of steps for the next frame. When all frames have been displayed, the system exits this loop. Flow charts for a typical control program for CPU 23 are shown in FIGS. 10-13. Referring first to FIG. 10, the program is entered at 100. CPU 23 interrogates parallel interface 26 to see if the host computer 28 is requesting action. If no action is requested the control program continues to interrogate parallel interface 26. If host computer 28 requests action the control program evaluates the request, as shown by block 102 to see if it should enter the data capture routines in FIGS. 11a-b. If this action is required, the data capture routines, described below, are entered as shown at block 103. If the data capture routines are not required the control program tests to see if it should enter the display and analysis routines in FIGS. 12-13. If this action is required the display and analysis routines, described below, are entered, as shown at block 105. If neither of these actions is required, the control program returns to block 100 and monitors the parallel interface for further requests from host computer 28. A flow chart indicating the data capture functions is shown in FIGS. 11a-b. This portion of the control program allows the operator to direct CPU 23 to carry out various functions, as described below. Function 110 ("Set Display Cycle Speed?"): This function controls the repetition rate for displaying the sequential samples of pressure data. As shown in block 111, the operator inputs a value between 0 and 9 from host computer 28. A value of 9 selects the highest possible display rate, while progressively lower values slow the rate down. The value of 0 "freezes" the display at the currently displayed frame. Function 112 ("Display Next Frame?"): This function is selected by the operator by inputting a space character from host computer 28. This selects the next frame in sequence, as shown at block 113, allowing the operator to step through the display of sequential pressure data (when used in combination with the frame display rate value 0). Function 114 ("Display Previous Frame?"): This function is selected by the operator inputting the minus character from host computer 28. This causes the displayed frame to be decremented (block 115), allowing the operator to step backwards through the display of sequential pressure data (when used in combination with the frame display rate value 0). Function 116 ("Save Data on Disk?"): When the host computer requests this function pressure data from video RAM 16 is transferred via parallel interface 26 to host computer 28, which stores the data in a file on hard disk 202 or diskette 205. The values for the force transducer data are also transferred and saved, simultaneously. Function 118 ("Capture Dynamic Sequence?"): When the host computer requests this function the data capture routines previously described in FIG. 6 are entered, and a sequence of pressure events is sampled and stored in video RAM 16. Function 120 ("Capture Single Frame?"): When host computer 28 requests this function the data capture routines are entered but capture is limited to a single frame of data from video camera 5. Function 122 ("Set Offset D/A Automatically?"): When host computer 28 requests this function a routine is entered which sets video offset control 11 as follows: Video offset control 11 is loaded with a default value and one frame of video data is acquired and stored in video RAM 16. This video data is then transferred to host computer 28 which integrates the light values. The resulting integral is then compared with a pre-defined target value. If the integral has a higher value than the target value, video offset control 11 is reset with a new, increased value to raise the video offset voltage. This voltage is applied to gain and clamp circuit 9, which adjusts the level of video voltage applied to video ADC 10, such that background video levels are reduced. If the integral has a lower value than the pre-defined target level, video offset controller 11 is reset with a lower value. After the video offset voltage is reset a new frame of video data is acquired and the process is repeated. This procedure continues until the integrated light from the video field is within a predetermined margin of the target value. Function 124 ("Set Offset D/A Manually?"): This function allows the operator to load video offset control 11 with a value from host computer 28. The level of video background may thus be preset directly by the operator. Function 126 ("Continuous Image?"): If this function is selected by host computer 28, video ADC 10 will be turned on (block 127). This passes the video data directly through to color monitor 15 via color lookup device 13. Data is not stored during this process, which is intended to allow the operator to check for proper functioning of the video system. The control program then interrogates for input of an escape character from the host computer (block 128). If an escape character is received the control program turns off (block 129) video ADC 10. Function 130 ("Return to Main Menu?"): If this function is selected control program starts over again by returning to block 100. Referring to FIG. 12, a flow chart for the display and analysis functions is shown. This part of the control program allows the operator to direct CPU 23 to carry out various functions as follows: Function 140 ("Set Display Cycle Speed?"): This function controls the repetition rate for display of the sequential samples of pressure data. This function is selected (block 141) by inputting a number between 0 and 9 from the host computer. A value of 9 selects the highest possible rate for display. Progressively lower values will slow the rate down until a value of 0 which "freezes" the display at the currently displayed frame. Function 142 ("Display Next Frame?"): This function is selected by inputting a space character from host computer 28. It causes the displayed frame to be incremented (block 143), allowing the operator to step through the display of sequential pressure data (in combination with selecting the frame display rate value 0). Function 144 ("Display Previous Frame?"): This function is selected by inputting the minus character from host computer 28. It causes the displayed frame to be decremented (block 145), allowing the operator to step backwards through the display of sequential pressure data (in combination with selecting the frame display rate value 0). Function 146 ("Load Data from Host?"): This function instructs host computer 28 to download (block 147) a file of previously collected pressure data to video RAM 16. This data is calibrated by host computer 28 before downloading. Once in video RAM 16, the data is displayed on color monitor 15 via color lookup table 13. Function 148 ("Analysis Functions?"): When host computer requests this function the control program enters the flow chart shown in FIG. 13 at point 160. These functions are described below. Function 150 ("Return to Main Menu?"): When host computer 28 requests this function the control program returns to the beginning (block 100) of the flow chart in FIG. 10. If this function is not requested, the control program stays in the "Display and Analysis Functions" and continues testing for requests. Referring to FIG. 13, a flow chart illustrating the Analysis Functions is shown. This part of the control program allows the operator to interactively test areas of interest in the pressure data for further analysis, as described below: Function 160 ("Set Area Size?"): This function allows the operator to set the size of the area of interest. This is done by incrementing or decrementing the radius of area (block 161). Host computer 28 sends data to video RAM 16 which produces an image of the circle of selected radius on color monitor 15. Function 162 ("Move to New Area?"): If this function is selected, host computer 28 re-draws the circle for the area of interest in video RAM 16 at new co-ordinates. This allows the operator to reposition the area of interest on the screen. Function 164 ("Enter Area?"): This function allows host computer 28 to re-draw the circle for the area of interest in a different color, and this circle is then retained on the image. The circles position and radius are saved (block 165) by host computer 28 for incorporation into the data file. Function 166 ("Set New Top Point?"): When host computer 28 selects this function the pressure data in each frame of information is repositioned to coordinates provided by host computer 28 (block 167). This has the effect of repositioning the data on the color monitor display. Function 168 ("Analyse?"): When host computer 28 selects this function CPU 23 generates data into video RAM 16 to draw graphs of maximum pressure against time (block 169) within each area of interest selected. The data for the graphs is obtained by searching each frame of video data in video RAM 16 for a value for maximum pressure within each of the indicated areas. Function 170 ("Save Areas?"): When this function is selected host computer 28 saves the pressure data together with the information on circle position and radius for the selected areas of interest (block 17). Function 172 ("Return to Display & Analysis Functions?"): When this function is requested by host computer 28 the control program returns to block 140 in FIG. 12. Otherwise the control program returns to the beginning of the Analysis functions, block 160. As indicated by the foregoing description of the control program, the system permits the user to modify the displayed video data. For example, if he wants to draw a circle in a specified color around a particular area of interest in one video frame, the corresponding pixel elements are changed to a digital value corresponding to that color. This is done in a conventional manner using a separate "graphics" frame which has zero values for its pixels everywhere. The pixel values for the desired circle are added to the corresponding pixel "zeros" in the graphics frame to generate the desired color therein. The graphics frame is then displayed after the last frame containing pressure data. Since the system cycles through the frames at a sufficiently fast repetition rate (e.g., 30 frames per second), the circle generated by the graphics frame appears to be superimposed on the other frames. Obviously, numerous additional modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims the invention may be practiced otherwise than as specifically described herein.

1a

CLAIM OF PRIORITY [0001] This patent application claims priority on U.S. Patent Provisional Application Ser. No. 60/958,501 entitled System and Method for Performing Physiological Assessments filed Jul. 6, 2007. FIELD OF THE INVENTION [0002] This invention is directed to a system and method for performing and recording results from a physiological assessment and more specifically to a physiological assessment of sexual attention for aiding in the evaluation, diagnosis or treatment of paraphilias, sexual dysfunctions, gender identity disorders, related sexual disorders. BACKGROUND OF THE INVENTION [0003] Forensic examiners are often used to provide expert opinions as to whether a test subject has a mental disorder such as a pedophilia or another paraphilia. Several states have laws which provide for the involuntary commitment and treatment of sexually violent predators (SVPs). One method of evaluating test subjects is to use the classification system described in the Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV). However, there is criticism to using the information from the DSM-IV since there is believed to be insufficient data concerning its reliability. [0004] Prior to subjecting an individual to involuntary mental health treatment, it would be advantageous to ensure that the individual is truly a sexually violent predator. Generally, states have adopted the standard that prior to subjecting someone to involuntary mental health treatment, there should be a legal finding that the person has a mental abnormality or personality disorder that makes the person likely to engage in acts of sexual violence. In order to make this determination, evaluators customarily use the diagnostic categories described in the DSM-IV and the sections concerning personality disorders and paraphilia disorders in particular. [0005] Whether or not an individual meets criteria for civil commitment is a legal finding ultimately made by a judge or jury, but the diagnostic conclusions drawn by mental health professionals are central to this process. Therefore, it is important to have a reliable method for making such diagnostic conclusions. [0006] Research has shown that the overall recommendation decisions made by evaluators using DSM-IV standards were characterized as having “poor” reliability. These studies raised concerns about the credibility of civil commitment evaluations based upon DSM-IV and other such means. The consequences to the individual being evaluated and to public safety if incorrect determinations are made could be devastating. [0007] Prior attempts to provide a diagnosis tool have several shortcomings. For example, the Abel Assessment of Sexual Interest-2 (AASI-2) attempts to measure sexual interest through measuring the time that a test subject views a single photograph. Photographs are displayed to the test subject in linear fashion and the time that the test subject views the photograph is recorded. However, AASI-2 is limited to this single metric. Further, AASI-2 can more easily be “fooled” since the test subject need only vary the amount of time each photograph is viewed. Results from the AASI-2 test must be sent to Abel Screening Inc before the test results can be known for the test subject thereby creating significant delay between the times where the test is given and when the test results are reported. Further, AASI-2 displayed models only a limited number of times, two in its current version, so that there is a limited ability to verify responses from test subjects. [0008] It would be advantageous to have a system and method for testing with physiological assessment which contains multiple measures as well as measures of non-conscious reflective actions, shortened test results scoring times, and external validation of test subject responses. SUMMARY OF THE INVENTION [0009] The above objectives are accomplished by providing a system and method for assessing sexual attention of a test subject comprising: a computer readable medium; a display in electronic communications with the computer readable medium; an eye-tracking sensor in electronic communications with the computer readable medium for tracking eye movement of the test subject viewing the display; a set of display sets embodied in the computer readable medium where each display set has images representing individuals having a plurality of different genders and age groups wherein each display set contains images having a unique combination of gender and age group; and; a set of computer readable instructions embodied in the computer readable medium for display the display sets on the display, determining the test subject's eye fixation time for each image, determining the test subjects saccade time for each displayed image, determining a gaze score according to the fixation time and the saccade time, and determining a gaze score for each combination of gender and age group. [0010] The invention can include a set of base line gaze scores embodied in the computer readable medium and derived from normalized group testing; and, the set of computer readable instructions include instructions for comparing the determined gaze scores with the set of baseline gaze scores so that a comparison of the test subject's gaze scores can be compared with normalized group test results. The display set can includes an image of an adult male, an adult female, teen male, teen female, prepubertal male, prepubertal female, preschool male and preschool female. The computer readable instructions can include instructions for determining the gaze score representing how long images of an adult male, an adult female, teen male, teen female, prepubertal male, prepubertal female, preschool male and preschool female each held the test subject's gaze. The set of display sets contain images of individuals having a plurality of different ethnic origins and wearing different attire. DESCRIPTION OF THE DRAWINGS [0011] The invention will be described herein with reference to the following drawings: [0012] FIG. 1 is a diagram of components of the invention; [0013] FIG. 2 is a representation of displayed images of the invention; [0014] FIG. 3 is a flow chart of the invention; [0015] FIG. 4 is a representation of the output from the invention; and, [0016] FIG. 5 is a representation of the output from the invention. DETAILED DESCRIPTION OF THE INVENTION [0017] An object or module is a section of computer readable code embodied in a computer. The detailed description that follows may be presented in terms of program procedures executed on a computer or network of computers. These procedural descriptions are representations used by those skilled in the art to most effectively convey the substance of their work to others skilled in the art. These procedures herein described are generally a self-consistent sequence of steps leading to a desired result. These steps require physical manipulations of physical quantities such as electrical or magnetic signals capable of being stored, transferred, combined, compared, or otherwise manipulated readable medium that is designed to perform a specific task or tasks. Actual computer or executable code or computer readable code may not be contained within one file or one storage medium but may span several computers or storage mediums. The term “host” and “server” may be hardware, software, or combination of hardware and software that provides the functionality described herein. [0018] The present invention is described below with reference to flowchart illustrations of methods, apparatus (“systems”) and computer program products according to the invention. It will be understood that each block of a flowchart illustration can be implemented by a set of computer readable instructions or code. These computer readable instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine such that the instructions will execute on a computer or other data processing apparatus to create a means for implementing the functions specified in the flowchart block or blocks. [0019] These computer readable instructions may also be stored in a computer readable medium that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in a computer readable medium produce an article of manufacture including instruction means that implement the functions specified in the flowchart block or blocks. Computer program instructions may also be loaded onto a computer or other programmable apparatus to produce a computer executed process such that the instructions are executed on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart block or blocks. Accordingly, elements of the flowchart support combinations of means for performing the special functions, combination of steps for performing the specified functions and program instruction means for performing the specified functions. It will be understood that each block of the flowchart illustrations can be implemented by special purpose hardware based computer systems that perform the specified functions, or steps, or combinations of special purpose hardware or computer instructions. The present invention is now described more fully herein with reference to the drawings in which the preferred embodiment of the invention is shown. This invention may, however, be embodied any many different forms and should not be construed as limited to the embodiment set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. [0020] Referring to FIG. 1 , a computer 10 having a computer readable medium 12 contains computer readable instructions. A display 14 is in communication with computer 10 for displaying images to a user. Referring to display 14 a , a sensor 16 is able to determine an individual's pupil in order to determine the direction of the individual's gaze. Therefore, an eye tracking sensor or sensor 16 will allow computer readable instructions to determine which area of the display the user is gazing. Further, sensor 16 will also be able to determine fixation and saccade. Fixation is the amount of time that an individual gazes at a specific location. Saccade is the amount of time that transpires when a user looks from one location to another on the display. [0021] In one embodiment, the user has eight images which are displayed on display 14 . The set of images 18 can be numbered one through eight for identification purposes. The test subject can then be asked a question such as “Which of these do you find most sexually attractive?”, and can use the mouse or other input device to indicate which of the images is selected. During the time in which the user is viewing the set of images, sensor 16 is determining fixation and saccade of the test subject for each of the images. This information is transmitted to computer 10 and stored in computer readable medium 12 . With fixation and saccade known for a particular image, a gaze time can be calculated for each of the displayed images. [0022] Saccades are quick, simultaneous movements of both eyes in the same direction. Using the fixation on an image and the saccade across displayed images, a gaze time for each of the displayed images can be determined. Knowing the total display time of a display set having displayed images, a percentage of total gaze score for each image displayed can be determined. [0023] While there are multiple methods for calculating the gaze percentage of a test subject for displayed images, one example is if it is determined that the display set is displayed for 18 seconds and one image holds the gaze of the test subject for 4 seconds, the image is calculated to have held the test subject's gaze for approximately 22% of the time ( 4/18). In this example, the gaze percentage would be 22%. [0024] In another example, the number of fixations to a specific image can be included in the calculation. If the test subject returns his gaze to a particular image 10 times, then the number of fixations score would be 10 and this value can be used in combination with the gaze percentage score to provide more reliable data about the test subjects gaze returning to a particular image. [0025] In one embodiment, sensor 16 is located on a desk below display 14 . Sensor 16 then determines gaze of the user and saccade of the user and will transmit this information at computer 10 . In one embodiment, the eye-tracking sensors are the TM3 offered by Eye Tech Digital Systems. In one embodiment, the sensor can be worn by the test subject. [0026] Referring now to FIG. 2 , a set of images is shown generally as 22 . In one embodiment, sixteen sets are used. Four different models of each gender (male and female) are used in a set. Further, the attire is held consistent across a display set and ranges from fully clothed to wearing swimsuits or undergarments. Each set also contains four age groups which can be described as adult, teenage, prepubertal, and preschool. Generally, prepubertal is the age range between eight to thirteen, while preschool is under eight years old. Each set can also be of a different ethnic origin and the ethnic origins can be held constant across a particular display set. Ethnic origins can include Caucasian, African-American, Hispanic, or other ethnic origins. Therefore, each set would contain four males and four females, two adults, two teenagers, two prepubertal and two preschool individuals and have ethnicity and attire consistent. In one embodiment, two ethnicities are used and two attires are used which result in sixteen sets of eight or 128 images. [0027] Advantages that are offered by this invention are that images are presented in groups rather than one at a time and the test subject's fixation duration, number of fixations to each image and saccades between each image can be measured. It does not rely on simply measuring how long, or fixation, a test subject has with a single image. Although fixation can be measured for an image of the group, the invention also allows the measurement of saccade between the images. [0028] For example, results from the sensor 16 are shown generally as 24 of FIG. 2 . It can be shown the test subject initially gazes upon image 7 having an initial point 26 . The amount of time the individual gazes at image 7 is recorded in the computer readable medium. The test subject then moves the gaze to point 28 which allows the invention to measure both the amount of time it took for the test subject to move to point 28 as well as how long the test subject gazed at point 28 . The test subject then moves to point 30 , 32 , 34 , 36 , and 38 , respectively, with the amount of time measured when the gaze shifts as well as the fixation on the particular images. As can be seen, this test subject had a fixed gaze, mostly at image 2 . If image 2 represents an adult female and the test subject is male, the results would be typical for a heterosexual male's sexual attention. However, if image 2 was a preschool male, it would indicate there may be an atypical sexual attention propensity to boys in this test subject. Test results shown as 40 show that the saccade of the test subject follows a greater path, but again shows that the test subject gazed upon image 6 more than the remainder of the images. Further, it can be shown that the saccade of the test subject caused a viewing path to travel through image 3 , but the test subject did not fix his gaze on image 3 for any appreciable period of time. Based upon the fixation durations, number of fixations and saccade durations measured by the invention and relationship of these measures with the particular type of image displayed, an indication can be given toward the sexual attention of the test subject. [0029] In addition to the fixation duration determined by sensor 16 , the invention is also able to determine the number of times the test subject visually fixates on a particular image. Further, since multiple sets of images are provided, the time the test subject views each model or type of model can be determined. The sets of images also allow for the progression of the test subject's gaze so that the sequence of images can be determined as viewed by the test subject. This can be helpful in showing if a test subject re-fixates on an image previously viewed since sets of images are displayed. [0030] It should also be noted that in one embodiment and according to research and literature on sexual interests, ethnicity is consistent across each set since there is some indication that adult males tend to have sexual interests and attention in persons of their same ethnicity by making the test having the ability to be tailored toward the ethnicity of the test subject. [0031] Further advantages provided by this invention are that measurements are done in near real-time and therefore can calculate unconscious, reflexive eye movements beyond a test subject's awareness. This can provide for more accurate and valid indications of sexual interest since fixation and saccade as well as image progression and other recorded information are much more difficult to consciously control. This invention also has the ability to generate group information allowing normalized test ranges which can help establishing base lines for using this invention. [0032] Further, the test results of this invention can be immediately knowable to the clinician or individual administering the tests without the need to transmit the measurements to any third party and await an interpretation or diagnosis. Further, the results can be independently verified by other clinicians or researchers since the scoring of the invention can be repeated. [0033] This invention can assist in psychological testing to aid in the evaluation, diagnosis, and treatment of pedophilia in both adult and adolescent males and although much rarer, in adult and adolescent females. This invention may also help to empirically validate the diagnosis of a person's particular pedophilia as well as a test subject's type of pedophilia. This invention can also be used for adolescents and can be helpful in the early diagnosis of pedophilia allowing a clinician much longer time for treatment which may reduce the likelihood of adult sexual recidivism, particularly against children. [0034] This invention also has applications as a screening tool to determine the pedophilic interests of job applicants. Clearly, there are some jobs such as daycare, child protective services, juvenile justice, handicap services, education field, and other industries in which knowing whether an individual has unacceptable pedophilic interests would be of great value. [0035] In use of the invention, the sensor is calibrated at 42 . The images are then randomized into sixteen subsets with ethnicity and attire remaining constant and having four male, four female, in two of each age group, in each of the sixteen subsets at 44 . If the last subset is displayed at 46 , the information recorded from the test subject viewing the images is made at 48 . If the last subset of images is not displayed, the current subset is displayed at 50 . The eye movement information including fixation and saccade is measured at 52 . If the set has been displayed for eighteen seconds at 54 , at a two-second interval, then the invention moves to the next subset at 56 . The process returns to 46 to determine if that was the last subset displayed. If the subset has not been displayed for eighteen seconds, it remains viewable by the test subject and eye movement information continues to be recorded at 52 . [0036] Referring to FIG. 4 , an example of test results is given. There are several scales which can be used. “NR” represents no response; “Cn” represents congruence; “OffD” represents off duration; “A+” represents Adult female+; “C−” represents child−; “ScD” represents saccade duration. There are also a number of clinical scales which can measure the subject's eye movement and can include fixation duration (FxD) or number of fixations (NFx) to each of the various model types and images viewed. The invention can also provide composite clinical scales that focus on same sex children of certain age groups (CMT) (CFT) as well as boys and girls in a single age group (PM+PF) and non-adolescent boys and girls (CT). The test subjects can be compared to normals of the same ethnicity so as to remove any data distortion between ethnicities. These scores can then be reported which would represent the test subject's results per the scale compared to the average test score of a normal group. This will allow the evaluator or clinician to quickly interpret the text subject's sexual interest and can be used to formulate categories of sexual interest in children as being very high, high, within normal limits, low, or very low. This allows for quick and easy determinations of the results. [0037] Referring to FIG. 5 , an example of cumulation of results is shown. As can be shown, for a normal male, over sixty percent of the gaze was spent on adult females from results taken from this invention. However, for sexually violent predators (SVP), almost forty percent of the gaze percentage was spent on prepubertal females. [0038] This invention can also use a Tobii E-17 eye tracking device in order to determine the gaze and saccade of a test subject. [0039] This invention can record initial fixation which is the first duration and location of the test subject's gaze. The initial fixation to one of the images of the set of images is the first fixation, then saccade to another image of the set for the second fixation which is the amount of time the test subject gazes at the second image, then a saccade back to the first image, or another image, which would be third fixation, and so on. The frequency, consistency, fixation, duration, and pattern of re-fixation of the test subject's gaze provides information to indicate the individual's sexual attention preferences for males and/or females of varying ages. [0040] This invention can also be used to assist and aid in the evaluation, diagnosis, and treatment of paraphilias (especially pedophiles) of certain sexual dysfunctions, gender identification disorders, and related sexual disorders such as ego-dystonic gender orientation. [0041] This invention may also be helpful to determine whether the sexual attention of an individual is changing. Since this is an objective way of measuring the psychological treatment of a test subject's pedophilia, it can be measured to determine if there are improvements based upon treatment or other factors. [0042] This invention can enhance psychiatrists, psychologists, and other health care providers to diagnose and perform forensic analysis concerning test subjects who have been charged or convicted of sexually violent predator acts and/or have become subject to post-incarceration involuntary treatment in the various states. [0043] While a preferred embodiment of the invention has been described using specific terms, such description is for illustrative purposes only, and it is to be understood that changes and variations may be made without departing from the spirit or scope of the following claims.

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CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to a corresponding provisional application U.S. Ser. No. 61/187,168, filed Jun. 15, 2009 in the name of the Applicant, which is incorporated herein by reference. This application is also related to U.S. Pat. No. 6,821,288, which was issued on Nov. 23, 2004 in the name of the Applicant and which is also incorporated herein by reference. FIELD OF THE INVENTION [0002] This invention relates generally to therapy tables, and more specifically, to an automated therapy table having various support portions capable of independent automatic actuation of a person's lower extremities through passive exercise by performing leg elevation, approximation/decompression of the leg, internal/external rotation of the leg, ankle plantar flexion/dorsiflexion, and foot inversion/eversion. BACKGROUND OF THE INVENTION [0003] Over 2.5 million people worldwide suffer from Multiple Sclerosis (MS) and over a quarter of a million children and adults suffer from some form of joint contracture. Joint contracture is a stiffening of the muscles near the joints that can make it difficult for individuals to move. In some cases, this leads to joints locking in a painful position. [0004] Physical therapy, especially regular stretching, is important in helping to enhance the range of motion for affected muscles and to prevent or delay contractures. Physical therapy can also help maintain muscle tone and reduce the severity of joint contractures. With regular exercise, muscles are kept strong and joints more flexible. It is believed that strengthening supporting muscle groups to compensate for weakened muscle groups might be beneficial to patients with early stages of Muscular Dystrophy (MD). [0005] People with various forms of debilitating illnesses, such as Multiple Sclerosis (MS), Charcot-Marie-Tooth (CMT), and Muscular Dystrophy (MD) suffer from progressive weakness, pain, and degeneration of skeletal muscles that are required for voluntary movement. For treatment, these people often seek the assistance of a physical therapist, chiropractor, or other medical practitioner in order to alleviate their discomfort. A physical therapist will often resort to stretching techniques to ease a patient's discomfort—positioning the patient on a therapy table and manually stretching and manipulating the patient's body. This can be physically demanding for the therapist. The lower extremities are especially difficult to manipulate because of their length, size, and weight. [0006] A need therefore existed for an automated therapy table which may be controlled by a physical therapist or other medical practitioner to actuate various component portions of the table in order to move parts of a person's body, specifically the lower extremities, in a desired direction for a desired period of time without causing physical stress to the physical therapist or medical practitioner. All of the functions of the automated therapy table, accompanied by the thought process of the patient assisting in the direction of every movement, help to rehabilitate and strengthen muscles. SUMMARY OF THE INVENTION [0007] In accordance with one embodiment of the present invention, a therapy table is disclosed. The therapy table comprises at least one torso platform for supporting a torso of a person, and an exercise platform coupled to the torso platform, the exercise platform for exercising at least one of a leg and a foot of the person in a desired range of motion. [0008] In accordance with another embodiment of the present invention, a therapy table is disclosed. The therapy table comprises a base, a torso platform coupled to the base for supporting a torso of a person, and at least one exercise platform coupled to the torso platform, the exercise platform for exercising at least one of a leg and a foot of the person in at least one of leg elevation, leg approximation, leg decompression, medial leg rotation, lateral leg rotation, ankle plantar flexion, ankle dorsiflexion, foot inversion, and foot eversion. [0009] In accordance with another embodiment of the present invention a method for treating the lower extremities of a person is disclosed. The method comprises the steps of providing a therapy table comprising a torso platform for supporting a torso of a person; at least one exercise platform coupled to the torso platform, the exercise platform for exercising at least one of a leg and a foot of the person in at least one of leg elevation, leg approximation, leg decompression, medial leg rotation, lateral leg rotation, ankle plantar flexion, ankle dorsiflexion, foot inversion, and foot eversion; and thinking by the person of a particular movement while performing one of leg elevation, leg approximation, leg decompression, medial leg rotation, lateral leg rotation, ankle plantar flexion, ankle dorsiflexion, foot inversion, and foot eversion. BRIEF DESCRIPTION OF THE DRAWINGS [0010] The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein: [0011] FIG. 1 is a perspective view of one embodiment of an automated therapy table for treating lower extremities in accordance with the present invention. [0012] FIG. 2 is a side view of the automated therapy table of FIG. 1 , shown performing the movement of leg elevation. [0013] FIG. 3 is a side view of the automated therapy table of FIG. 1 , shown performing the movement of leg approximation. [0014] FIG. 4 is a side view of the automated therapy table of FIG. 1 , shown performing the movement of leg decompression. [0015] FIG. 5 is a perspective view of the automated therapy table of FIG. 1 , shown performing the movement of internal leg rotation. [0016] FIG. 6 is a perspective view of the automated therapy table of FIG. 1 , shown performing the movement of external leg rotation. [0017] FIG. 7 is a side view of the automated therapy table of FIG. 1 , shown performing the movement of ankle plantar flexion. [0018] FIG. 8 is a side view of the automated therapy table of FIG. 1 , shown performing the movement of ankle dorsiflexion. [0019] FIG. 9 is a top view of the automated therapy table of FIG. 1 , shown performing the movement of foot inversion. [0020] FIG. 10 is a top view of the automated therapy table of FIG. 1 , shown performing the movement of foot eversion. [0021] FIG. 11 is a side view of the automated therapy table of FIG. 1 . [0022] FIG. 12 is a side view of a gear mechanism and femur support portion of a clamp of the automated therapy table of FIG. 1 . [0023] FIG. 13 is a perspective view of the femur support of the automated therapy table of FIG. 1 . [0024] FIG. 14 is an exploded view of a roller assembly and foot housing which may be used with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0025] The novel features believed characteristic of the invention are set forth in the appended claims. The invention will best be understood by reference to the following detailed description of illustrated embodiments when read in conjunction with the accompanying drawings, wherein like reference numerals and symbols represent like elements. [0026] Referring to FIGS. 1-14 , an automated therapy table for treating lower extremities, hereinafter automated therapy table 10 , is shown. The automated therapy table 10 is dimensioned to support a person 46 in a supine position and to assist the person 46 in performing passive controlled movements such as: leg elevation, approximation/decompression of the leg 48 , internal/external rotation of the leg 48 , ankle plantar flexion/dorsiflexion, and foot inversion/eversion. In its simplest form, the therapy table 10 comprises a torso platform 20 for supporting the torso of the person 46 and an exercise platform 21 to assist the person 46 in any one or any combination of the aforementioned exercises. [0027] Referring to FIG. 1 , the automated therapy table 10 may have a base 11 , a lumbar platform 12 , a thoracic platform 14 , two arm platforms 16 , and a head support 18 . It should also be clearly understood that substantial benefit may be derived from the automated therapy table 10 having one whole upper body platform to support the person's torso, head 58 , and arms 56 or from the automated therapy table 10 having certain platforms combined to form one piece (e.g. the thoracic platform 14 and the lumbar platform 12 may be combined together to form a torso platform 20 ). [0028] The automated therapy table 10 is shown as having two leg platforms 22 and two foot plates 44 movably coupled to an inferior end of the torso platform 20 . While each leg platform 22 could comprise a single section capable of medial/lateral or posterior/anterior movement, it is preferred that each leg platform 22 be multi-sectioned in a manner corresponding to the leg 48 and ankle 52 joints. [0029] FIG. 2 shows the automated therapy table 10 performing the passive movement of leg elevation. Leg elevation helps relieve lower leg swelling, which is commonly known as leg edema. Leg edema is typically caused by abnormal accumulation of fluid in the tissues of the lower extremity. Usually, individuals who sit for long periods of time, experience leg tightness or leg edema. To prevent this, individuals who are bed-ridden or lack mobility should elevate their legs as often as they can to loosen tight muscles. Leg elevation is also beneficial in returning blood to the body, which can improve leg circulation. [0030] In order for the therapy table 10 to be able to assist a person 46 in the performance of this movement, the exercise platform 21 may have a leg platform 22 hingedly coupled to the torso platform 20 with a hinge assembly 32 . In one embodiment, the therapy table 10 will have a support member 60 coupled to a bottom surface of the leg platform 22 . A pivot arm 62 may have one end pivotably coupled to a distal end of the support member 60 of the leg platform 22 and may have another end pivotably coupled to a bottom surface of the torso platform 20 . There may also be an actuator 34 having one end that is pivotably coupled to a proximal end of the support member 60 of the leg platform 22 and another end that is pivotably coupled to the base 11 of the therapy table 10 . When the actuator 34 extends, the leg platform 22 is raised and when the actuator 34 retracts, the leg platform 22 is lowered back to a resting position. While it is shown in the figure that the hinge assembly 32 has two pivot arms 62 , it should be clearly understood that substantial benefit may be achieved from a single pivot arm 62 or more than two pivot arms 62 . [0031] FIGS. 3 and 4 show the automated therapy table 10 performing the passive movements of approximation (see FIG. 3 ) and decompression (see FIG. 4 ) of the leg 48 . Leg approximation/decompression help relieve joint pain caused by compression and flexion. Joint pain can be alleviated by decreasing pressure on the joint and by increasing blood flow by eliminating metabolic waste, which can reduce inflammation and numbness in the leg. Decompression is a safe and natural alternative to surgery, injections or prescription medication. One of the primary benefits of approximation is to simulate weight bearing to maintain/increase bone density in individuals who lack mobility. [0032] In order for the therapy table 10 to be able to assist a person 46 in this type of movement, the exercise platform 11 may have a leg platform 22 for supporting the leg 48 of the person 46 , a foot housing 42 coupled to the leg platform 22 for supporting the foot 50 of the person 46 , and at least one actuator 34 . The actuator 34 may have one end coupled to the foot housing 42 and may have another end coupled to the leg platform 22 . When the actuator 34 extends, the foot housing 42 moves in an inferior direction, and thus allows the leg 48 to move inferiorly along a frontal plane (leg approximation). When the actuator 34 retracts, the foot housing 42 moves in a superior direction, and thus allows the leg 48 to move superiorly along a frontal plane (leg decompression). [0033] To further assist in this movement, the exercise platform 11 may also have a roller assembly 35 . The roller assembly 35 may comprise a roller block housing 38 (see FIG. 14 ) coupled to the distal end of the leg platform 22 and at least one roller 37 within the roller block housing 38 . A roller block 40 may be coupled to the roller 37 within the roller block housing 38 and a bi-directional roller 36 may be coupled to the roller block 40 . At least two rows of wheels 39 may be coupled to a distal end of the bi-directional roller 36 and at least two corresponding tracks 41 may be present in the bottom surface of the foot housing 42 ; each track 41 would be dimensioned to receive a row of wheels 39 . The roller assembly 35 would assist the movement of the foot housing 42 in an inferior and superior direction as the rollers 37 move within the roller block housing 38 . [0034] FIGS. 5 and 6 show the automated therapy table 10 performing the passive movements of internal or medial (see FIG. 5 ) and external or lateral (see FIG. 6 ) leg rotation. These movements help strengthen and stabilize the respective rotators of the hip. Over time, the piriformis muscle tightens from the lack of immobility and use. It is believed that internal and external leg rotations improve a person's motional disability by preventing external torsion of the tibia. The exercise platform 21 of the therapy table 10 may assist these movements if it has a leg platform 22 for supporting the leg 48 of the person 46 and a rotation assembly 29 . The rotation assembly 29 may have a leg restraint 24 (such as a clamp 25 or strap) coupled to the leg platform 22 for securing the leg 48 in place. There may be a plurality of teeth 64 coupled to a bottom portion of the leg restraint 24 and a gear mechanism 28 coupled to the leg platform 22 that also has teeth that mesh with the teeth 64 of the leg restraint 24 . When the gear mechanism 28 is rotated, it causes the leg restraint 24 to rotate the leg 48 either medially or laterally. The roller assembly 35 may also assist the movement of the foot housing 42 in lateral rotation and medial rotation when the wheels 39 move along the tracks 41 of the foot housing 42 . Furthermore, the exercise platform 21 may also have at least one rail 26 coupled to the bottom portion of the leg restraint 24 and at least one channel 27 formed within a top surface of the leg platform 22 that receives the rail 26 . Together, the rails 26 moving within the channels 27 help to guide the rotation of the leg restraint 24 within the leg platform 22 . [0035] FIGS. 7 and 8 show the automated therapy table 10 performing the passive movements of ankle plantar flexion (see FIG. 7 ) and ankle dorsiflexion (see FIG. 8 ). These movements treat and help prevent lower extremity disorders associated with injury, illness or immobility, including ankle contractures. Since the ankle 52 controls the movement of the leg 48 relative to the foot 50 and is, therefore, subjected to the weight of the entire body and the forces generated by the dissipation of kinetic energy when the foot 50 makes contact with the ground, it has been determined that articulation of the ankle 52 through plantar flexion and dorsiflexion is paramount to relieving joint stiffness, inflammation, and providing increased range of motion. [0036] In order to assist with these movements the exercise platform 21 may have a leg platform 22 for supporting the leg 48 of the person 46 , a foot housing 42 coupled to the leg platform 22 for supporting the foot 50 , a foot plate 44 pivotably coupled to the foot housing 42 , and at least two actuators 34 . One actuator 34 may be a superior actuator 34 having one end coupled to the leg platform 22 and having another end coupled to an anterior portion of the foot housing 38 . The other actuator 34 may be an inferior actuator 34 having one end coupled to the leg platform 22 and having another end coupled to a posterior portion of the foot housing 38 . When the superior actuator 34 extends, it causes the anterior portion of the foot housing 38 to move, thereby allowing foot plantar flexion. When the inferior actuator 34 extends, it causes the posterior portion of the foot housing 38 to move, thereby allowing foot dorsiflexion. [0037] FIGS. 9 and 10 show the automated therapy table 10 performing the passive movements of foot inversion (see FIG. 9 ) and eversion (see FIG. 10 ). These are movements in which the sole of the foot 50 is made to face inward and outward, respectively. Foot inversion and eversion help eliminate metabolic waste and strengthens the calves and shins. [0038] In order to assist these movements, the exercise platform 21 may have a leg platform 22 , a foot housing 42 coupled to the leg platform 22 , a foot plate 44 pivotably coupled to the foot housing 42 , and four actuators 34 . A lateral superior actuator 34 a may have one end coupled to a lateral portion of the leg platform 22 and may have another end coupled to a lateral anterior portion of the foot housing 42 and a medial superior actuator 34 b may have one end coupled to a medial portion of the leg platform 22 and may have another end coupled to a medial anterior portion of the foot housing 42 . A lateral inferior actuator 34 c may have one end coupled to the lateral portion of the leg platform and may have another end coupled to a lateral posterior portion of the foot housing 42 and a medial inferior actuator 34 d may have one end coupled to the medial portion of the leg platform 22 and may have another end coupled to a medial posterior portion of the foot housing 42 . When the lateral superior actuator 34 a and the lateral inferior actuator 34 c extend, this allows for the movement of foot inversion. When the medial superior actuator 34 b and the medial inferior actuator 34 d , this allows for the movement of foot eversion. [0039] FIG. 11 shows the automated therapy table 10 in an at rest position. In one embodiment, the therapy table 10 may be used to perform all of the following movements: leg elevation, leg approximation, leg decompression, medial leg rotation, lateral leg rotation, ankle plantar flexion, ankle dorsiflexion, foot inversion, and foot eversion. In order to do so, the therapy table 10 may have a base 11 , a torso platform 20 coupled to the base 11 , a leg platform 22 , a support member 60 coupled to and extending downwardly from a bottom surface of the leg platform 22 , a roller assembly 35 coupled to a distal end of the leg platform 22 , a foot housing 42 coupled to the roller assembly 35 for supporting the foot 50 of the person 46 , a foot plate 44 pivotably coupled to the foot housing 42 , a hinge assembly 32 that pivotably couples the leg platform 22 to the torso platform 20 , an actuator 34 having one end pivotably coupled to a proximal end of the support member 60 and having another end pivotably coupled to the base 11 of the therapy table 10 . The table 10 may also have a plurality of actuators 34 , each actuator 34 having one end coupled to the leg platform 22 and having another end coupled to the foot housing 42 as well as a leg rotation assembly 29 coupled to the leg platform 22 . [0040] The leg platform 22 may be movably coupled to an inferior end of the torso platform 20 by the hinge assembly 32 . An actuator 34 or drive mechanism raises and lowers the leg platform 22 along a sagittal plane during leg elevation movements (see FIG. 2 ). The actuator 34 is coupled at one end to the leg platform 22 and the other end is either coupled to the base 11 or rests on the floor. [0041] As shown in FIGS. 12 and 13 , each leg platform 22 may have a leg restraint 24 , e.g. a hinged clamp 25 and/or straps to hold the patient's leg 48 in place. A system of rails 26 and gears 28 also may be used to allow internal and external leg rotation (see FIGS. 5 and 6 ), moving the leg 48 along a transverse plane. The leg platform 22 may have channels 27 to receive the rails 26 . These channels 27 and rails 26 may help to guide the leg restraint 24 as it rotates within the leg platform 22 . The clamp 25 , rails 26 , and gears 28 are shown positioned proximate the patient's 46 knee 54 joint. [0042] As shown in FIG. 14 , the leg platform 22 may also have a foot housing 42 where a patient's 46 foot 50 will rest and a foot plate 44 that is movably coupled to the foot housing 42 . In one embodiment, the foot housing 42 may be coupled to a bidirectional roller 36 , the bidirectional roller 36 may then be coupled to a roller block 40 , and the roller block 40 may be slidably coupled to a roller block housing 38 . The roller block 40 moves along a sagittal plane as the rollers 37 move within the roller block housing 38 , allowing for the ankle plantar flexion/dorsiflexion movements and for foot inversion/eversion movements. This design would also accommodate for the difference in the lengths of patients' 46 legs 48 . The bidirectional roller 36 also allows the foot 50 to move along a transverse plane, allowing for the foot inversion/eversion movements. The foot housing 42 may also have a hinged clamp and/or strap to hold the patient's 46 foot 50 in place. [0043] There may be a pair of actuators 34 or drive mechanisms on each of the lateral side and the medial side of each leg platform 22 . There may be one lateral superior actuator 34 a , one medial superior actuator 34 b , one lateral inferior actuator 34 c , and one medial inferior actuator 34 d may be used to move the foot housing 42 in relation to the leg platform 22 . The superior actuators 34 a / 34 b may be located directly lateral and medial to the patient's 46 legs 48 . An alignment enclosure 30 may be used to keep the superior actuators 34 a / 34 b straight. If all four actuators 34 a / 34 b / 34 c / 34 d extend at the same time, then the automated therapy table 10 will assist the movement of leg approximation (see FIG. 3 ), wherein the leg movement occurs along a frontal plane. If all four actuators 34 a / 34 b / 34 c / 34 d retract at the same time, then the automated therapy table 10 will assist the movement of leg decompression (see FIG. 4 ), which also occurs along the frontal plane. [0044] If the superior actuators 34 a / 34 b extend and the inferior actuators 34 c / 34 d contract or remain stationary, then the automated therapy table 10 will assist the movement of ankle plantar flexion (see FIG. 7 ), wherein the foot 50 moves along the sagittal plane. And if the superior actuators 34 a / 34 b contract or remain stationary and the inferior actuators 34 c / 34 d extend, then the automated therapy table 10 will assist the movement of ankle dorsiflexion (see FIG. 8 ), the foot 50 also moving along the sagittal plane. Furthermore, if the medial actuators 34 b / 34 d contract or remain stationary and the lateral actuators 34 a / 34 c extend, then the automated therapy table 10 will assist the movement of foot inversion (see FIG. 9 ), wherein the foot 50 moves along the transverse plane. And finally, if the medial actuators 34 b / 34 d extend and the lateral actuators 34 a / 34 c contract or remain stationary, then the automated therapy table 10 will assist the movement of foot eversion (see FIG. 10 ), the foot 50 also moving along the transverse plane. [0045] It is preferred that the patient 46 internalize or think about each movement while performing the movement. As an example, when the patient 46 performs the movement of decompression, the patient 46 may think “long” or “lengthening” as he/she performs the movement. This type of communicative balancing amplifies the benefit of the movement and is a valuable aspect of the method because it will help to maintain long-term effects from use of the automated therapy table 10 . [0046] In a preferred embodiment, the automated therapy table 10 is pneumatically driven. However, it should be clearly understood that substantial benefit could be derived from an alternative configuration of the automated therapy table 10 in which other automated means for adjusting the component portions and supports is used, such as hydraulic, electric or perhaps even lever-type means. [0047] This apparatus and process makes the job of the therapist significantly less difficult and less physically demanding. Thus, instead of the therapist being required to bend over the automated therapy table 10 , grasp a portion of the patient's 46 leg 48 , and physically move the patient's 46 leg 48 in the desired direction for the required period of time—the therapist can select the desired portion of the patient's 46 leg 48 , the desired direction of movement, and activate the appropriate actuators 34 . The actuators 34 will then move the appropriate part of the patient's 46 leg 48 in the proper direction, and the part of the patient's 46 leg 48 will be held there until the therapist determines that sufficient time has passed to make it appropriate to release the part of the patient's 46 leg 48 . While it is generally contemplated that the therapist will activate the actuators 34 , it would be possible for the patient to do so as well. STATEMENT OF USE [0048] It is preferred that a world trained technician, physical therapist, or other health professional operate the automated therapy table 10 of the present invention. It should also be clearly understood that substantial benefit may be derived from the patient being able to operate the automated therapy table 10 himself/herself. [0049] Prior to receiving any treatment, the patient 46 will ideally undergo a physical assessment to determine the existence of any contraindications. If there are any, then certain modifications may be made to the usual movements. [0050] For the movements of leg elevation, internal/external leg rotation, ankle plantar flexion/dorsiflexion, and foot inversion/eversion, the movement will be held for several seconds. Preferably, these movements will be held for less than ten seconds each. For the weight bearing movement of approximation (or compression), the movement may be held for longer than ten seconds. During each movement, the patient 46 will preferably be instructed to think in the direction of the movement. It has been found that doing so helps increase the healing effects. For example, during the movement of foot inversion, the patient 46 will think that his/her foot is moving inwardly toward the midsagittal plane of the body while his/her foot is actually moving inwardly toward the midsagittal plane of the body. As another example, during the movement of leg decompression, the patient 46 will think that about the lengthening of his/her hip muscle(s). Thinking in the direction of the movement is recommended for every movement of the automated therapy table 10 , except the weight bearing movement of leg approximation. [0051] The patient 46 may alternate movement of each of the lower extremities or the movements may be performed synergistically. Arm movement may also be performed in combination with the leg movements. For example, the patient's 46 arms 56 may be raised above the patient's head 58 and decompressed along the same plane (sagittal plane) as the patient's 46 legs 48 . And preferably, the patient 46 will be thinking about stretching his/her arms 56 and legs 48 . [0052] All of the movements described herein help to treat myofascial abnormalities. Myofascia is a thin film that wraps around muscle tissue. It wraps around the muscle fibers individually as well as the muscles themselves and also forms the tendons and ligaments which connect the muscles to other parts of the body. A great deal of pain can result when the myofascia of a person becomes tight or thick. Fibromyalgia syndrome (FMS) is an example of a condition wherein the lack of myofascial flexibility is present. When the myofascia loses its elasticity, the efficiency of neurotransmitters, which communicate messages between the brain and the rest of the body, are impaired. Among other symptoms, physical pain usually results from myofascial abnormalities. All of the movements disclosed herein will help to create myofascial release. [0053] This disclosure provides exemplary embodiments of the present invention. The scope of the present invention is not limited by these exemplary embodiments. Numerous variations, whether explicitly provided for by the specification or implied by the specification, such as variations in structure, dimension, type of material and manufacturing process may be implemented by one of skill in the art in view of this disclosure.

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TECHNICAL FIELD [0001] The invention relates to medical devices, and in particular, to medical devices used to guide diagnosis, monitoring and/or treatment of respiratory conditions. BACKGROUND [0002] Every day, patients with difficulty breathing seek medical help. In such cases, the patients may complain of shortness of breath, but may have no idea as to the cause of the condition. Many cases of shortness of breath fall into two general categories of respiratory disorders. [0003] One category of respiratory disorder that may cause shortness of breath is obstructive lung disease. A patient with obstructive lung disease suffers from a narrowing of the airways leading to the alveoli in the lungs. This narrowing, often caused by inflammatory reactions, results in a reduction of the patient's ability to ventilate the alveoli, because the narrowed airways reduce the maximum velocity of flow through the airways. Chronic obstructive pulmonary diseases such as asthma, bronchitis and emphysema, are some of the disorders that can cause narrowing of the airway. [0004] A second category of respiratory disorder that may cause shortness of breath is restrictive lung disease. Restrictive lung disease is characterized by a reduction of the overall gas-exchange area in the lungs. A restrictive lung disease may be temporary, such as a short-term filling of the alveoli with fluid, or more long-lasting, such as fibrosis that prevents the alveoli from expanding during inhalation. A restrictive lung disease may also be caused by congestive heart failure leading to pulmonary edema. [0005] When a patient complains of difficulty breathing, it is difficult for health care professionals to rapidly determine whether the problem is due to obstructive or restrictive origins. The symptoms caused by both conditions are similar. The patient's medical history may be of no help, or the patient may be incapable of giving a medical history due to age or a language barrier. [0006] To make a reliable diagnosis of obstructive lung disease or restrictive lung disease, physicians often employ a spirometer. A spirometer is a device that measures the flow and volume of air breathed in and out. The patient breathes into the device at the direction of a health professional. The measurements recorded in a spirogram can be used to distinguish obstructive lung disease from restrictive lung disease. [0007] There are, however, drawbacks to spirometry. First, spirometers are rarely available to health professionals treating a patient away from a hospital. Many emergency medical professionals are not trained in spirometry. Getting the patient to a spirometer and to a health professional trained in spirometry often takes time, and the patient's need for treatment may be urgent. Breathing difficulties can be life-threatening if not diagnosed accurately and treated promptly. [0008] Second, a proper spirogram requires the patient to exert effort to follow the directions of the health professional, such as directions to inhale as much air as possible, to exhale as hard as possible and to expel as much breath as possible. Patients that are short of breath may be incapable of following the directions. Young children also have difficulty with the effort-dependent system. [0009] Because obstructive lung disease and restrictive lung disease are treated with different methods and different medicines, distinguishing the conditions is important. Risks associated with making an incorrect diagnosis are dire. A patient who suffers from congestive heart failure but is misdiagnosed as suffering from chronic obstructive pulmonary disease, for example, may be mistakenly treated with a beta agonist. Beta agonist therapy can significantly increase myocardial oxygen consumption and worsen ischemia for that patient. SUMMARY [0010] In general, the invention is directed to techniques for rapidly and reliably distinguishing obstructive lung disease from restrictive lung disease. In addition, the invention is directed to techniques for monitoring the response of the patient to treatment for the condition. [0011] To distinguish obstructive lung disease from restrictive lung disease, the invention employs measurements of the concentration of carbon dioxide in the breath of the patient. A device such as a capnograph can be used to take these measurements, and the measurements taken by the capnograph are called a capnogram. The capnograph tracks the concentration of carbon dioxide during each exhaled breath. [0012] In a typical capnogram, the carbon dioxide concentration in the breath rises as a patient begins to exhale. The carbon dioxide concentration plateaus, then drops as the patient concludes exhalation. The shape of the curve that follows the carbon dioxide concentration is correlated to the ventilatory status of the patient. In particular, measurements of carbon dioxide concentration can be used to distinguish obstructive lung disease from restrictive lung disease. [0013] In one embodiment, the invention is directed to a method comprising measuring a concentration of carbon dioxide in a breath expired by a patient and using this measurement to determine the presence of obstructive lung disease or restrictive lung disease. The method may take into consideration, for example, the duration of a steady rise of the concentration of carbon dioxide in the breath or the rate of increase of the concentration of carbon dioxide, as measured by the initial angle and slope of the capnogram. The method may also compare the carbon dioxide concentration in the breath with a characteristic curve. The method may further include monitoring the condition of the patient following treatment. [0014] In another embodiment, the invention presents a device comprising a gas sensor that measures the concentration of carbon dioxide in a breath expired by a patient and a processor that determines the presence of obstructive lung disease or restrictive lung disease as a function of the measurement. The device usually includes an output device that reports the determination. [0015] In a further embodiment, the invention presents a method comprising measuring a concentration of carbon dioxide in a breath expired by a patient and guiding treatment as a function of the measurement. Guiding treatment may include determining the presence of lung conditions, determining the severity of the conditions, and selecting medications to treat the conditions. [0016] The invention may provide a number of advantages. For example, the invention quickly provides information to a health professional to guide treatment of the patient. In an exemplary usage, the invention rapidly and reliably distinguishes obstructive lung disease from restrictive lung disease without the need for a spirometer. Moreover, unlike a spirometer, the techniques of the invention may benefit patients that are incapable of following breathing directions. Furthermore, the invention may be small and easily portable, and may be brought to the patient by an emergency medical professional. As a result, the ventilatory status of the patient may be assessed quickly. [0017] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS [0018] [0018]FIG. 1A includes a chart and a diagram of a capnogram and a respiratory condition of a normal patient, for comparison to FIGS. 1B and 1C. [0019] [0019]FIG. 1B includes a chart and a diagram of a capnogram and a respiratory condition of a patient with an obstructive lung disease. [0020] [0020]FIG. 1C includes a chart and a diagram of a capnogram and a respiratory condition of a patient with a restrictive lung disease. [0021] [0021]FIG. 2A includes a chart of a capnogram of a patient with an obstructive lung disease. [0022] [0022]FIG. 2B includes a chart of a capnogram of a patient with a restrictive lung disease. [0023] [0023]FIG. 3 is a block diagram of an apparatus that is one embodiment of the invention. [0024] [0024]FIG. 4 is a flow diagram illustrating techniques for using capnography to analyze respiratory conditions. [0025] [0025]FIG. 5 is a flow diagram illustrating techniques for using capnography to monitor respiratory conditions following treatment. DETAILED DESCRIPTION [0026] [0026]FIGS. 1A, 1B and 1 C show a series of three charts 10 , 20 and 30 , each chart accompanied by a diagram of an alveolus 14 . Chart 20 shows a representative capnogram of a patient with obstructive lung disease, and chart 30 shows a representative capnogram of a patient with restrictive lung disease. Capnograms 20 and 30 are shown in reference to a capnogram 10 for a normal patient, i.e., a patient with no substantial lung disease. [0027] The alveoli accompanying capnograms 10 , 20 and 30 illustrates the nature of the condition of the patient. Each alveolus 14 includes a thin-walled inflatable sac 18 and a conducting airway 16 . The alveolus accompanying capnogram 20 shows obstructions 24 in airway 16 . Sac 18 may be able to expand and perform gas exchange, but expulsion of gas from sac 18 is hampered by obstructions 24 , which narrow the lumen of airway 16 . Obstructions 24 are characteristic of obstructive lung disease. [0028] The alveolus accompanying capnogram 30 shows restriction 34 in sac 18 , characteristic of restrictive lung disease. Restriction 34 may prevent sac 18 from expanding, or may limit the gas exchange performed by sac 18 . Airway 16 is clear, allowing unimpeded expulsion of breath, but restriction 34 limits the volume of gas in the breath. [0029] Capnograms 10 , 20 and 30 include tracings 12 , 22 and 32 , which plot the measured concentration of carbon dioxide in the breath as a function of time. Each tracing 12 , 22 and 32 shows the concentration of carbon dioxide rise, reach a plateau and drop. The shapes of tracings 12 , 22 and 32 , however, are different. As will be shown in more detail below, analysis of the shapes of tracings 22 and 32 may be used to distinguish obstructive lung disease from restrictive lung disease. [0030] Tracing 22 from a patient with obstructive lung disease shows a more gradual rise in the ascending slope of the carbon dioxide concentration, as compared with tracings 12 and 32 from a normal patient and a patient with restrictive lung disease, respectively. The more gradual rise is caused by the inability of the patient to exhale rapidly due to obstructions 24 . The patient ventilates adequately because sac 18 is clear, but the patient is not able easily to expel the contents of sac 18 through airway 16 . [0031] The ascending slope of tracing 32 from a patient with restrictive lung disease shows a rapid rise in carbon dioxide concentration when compared with tracing 22 , but a nearly normal rise in carbon dioxide concentration when compared with tracing 12 . A patient with restrictive lung disease has restriction 34 in sac but no obstructions to prevent exhalation of carbon dioxide, so the rise in carbon dioxide concentration is initially normal, or nearly so. The carbon dioxide concentration in tracing 32 , however, plateaus at a lower concentration when compared to tracings 12 and 22 , indicating that the patient is less adequately ventilated than the normal patient and the patient with obstructive lung disease. [0032] [0032]FIG. 2 provides a more detailed analysis of capnograms 20 and 30 . When a patient first begins to exhale, the carbon dioxide concentration in the first part of the breath is negligible. The first exhaled gases generally carry air from so-called “dead space,” i.e., the trachea, bronchi and other structures in the lungs in which no gas exchange takes place. In a typical patient, the volume of the dead space is approximately 150 mL. As gases from alveoli are expelled with air from the dead space, the concentration of carbon dioxide in the breath rises. When the dead space gases are mostly expelled, the concentration of carbon dioxide begins to reach a plateau. The plateau is typically not flat. [0033] Once the concentration of carbon dioxide in the breath begins to rise, the rise in concentration may be approximated by a straight line. The straight line may form the hypotenuse of a right triangle. In tracing 22 , the rise of carbon dioxide concentration is approximated by hypotenuse 42 of right triangle 40 , and in tracing 32 , the rise of carbon dioxide concentration is approximated by hypotenuse 52 of right triangle 50 . [0034] Base 46 of triangle 40 represents the duration of the rise of carbon dioxide concentration, i.e., the approximate time it takes for the carbon dioxide concentration in the breath of a patient with obstructive lung disease to reach a plateau. Height 44 of triangle 40 represents the concentration of carbon dioxide when the patient reaches the plateau. Likewise, for a patient with restrictive lung disease, base 56 represents the duration of the rise of carbon dioxide concentration, and height 54 represents the concentration of carbon dioxide when the patient reaches the plateau. [0035] Many of the quantities are related, and other quantities can be derived, by the application of trigonometry. For example, the areas of triangles 40 and 50 can be computed and the lengths of hypotenuses 42 and 52 can be determined. The rate of increase of carbon dioxide concentration can also be determined by taking the derivative of the beginning of tracings 22 and 32 , which gives the slope. [0036] Moreover, take-off angles 48 and 58 can be found. Take-off angles 48 and 58 are one measure of the slope of hypotenuses 42 and 52 , and are a function of how rapidly carbon dioxide concentration in the breath rises. Although take-off angles 48 and 58 can be derived by trigonometry from other measurements, take-off angles 48 and 58 can also be measured directly, independent of other parameters. [0037] As shown by tracing 22 , a patient with obstructive lung disease takes a longer time than a patient with restrictive lung disease to expel dead space air. This is shown by the more gradual slope of hypotenuse 42 , as compared to hypotenuse 52 . The gradual slope of hypotenuse 42 is indicative of obstructive lung disease because the gradual slope represents that it takes longer for the patient to move carbon dioxide-rich gas from his alveoli. [0038] By contrast, the slope of hypotenuse 52 is considerably steeper than hypotenuse 42 . The steep slope of hypotenuse 52 is not indicative of obstructive lung disease because it suggests a rapid expulsion of carbon dioxide-rich gas from the alveoli. The extent of hypotenuse 52 , height 54 and base 56 are small, however, when compared to the counterparts of triangle 40 . Another measure of the difference is the area of triangle 50 , which is considerably smaller than the area of triangle 40 . The smaller area of triangle 50 is indicative of restrictive lung disease because the patient suffers from restricted gas exchange, and cannot expel as large a volume of carbon dioxide-rich gas from the alveoli. [0039] Applying analysis techniques such as those described above, the initial carbon dioxide concentration in the exhalation of a patient can be used to distinguish obstructive lung disease from restrictive lung disease. A patient with obstructive lung disease expels carbon dioxide more slowly, but in greater volume, than a patient with restrictive lung disease. [0040] Importantly, capnograms 20 and 30 need not be effort-dependent. Unlike spirograms, in which the patient must follow a set of instructions, capnograms 20 and 30 may be taken while the patient is breathing as comfortably as he is able, without requiring the patient to follow any breathing instructions. The clarity of tracings 22 and 32 may be improved if the patient is able to follow simple breathing instructions from a health professional, but following the instructions is not essential to the invention. [0041] [0041]FIG. 3 is a block diagram of a system 70 that may be used to practice the invention. System 70 includes intake apparatus 72 . The patient exhales into intake apparatus 72 , which may be an apparatus such as a nasal cannula or a mask. The exhalation from the patient passes through tube 74 to gas sensor 76 , which measures the concentration of carbon dioxide in the breath. Gas sensor 76 may be part of a capnograph. Gas sensor 76 may measure carbon dioxide concentration using techniques such as infrared detection, which can track changes in concentration in real time. [0042] Gas sensor 76 passes measurements 90 to low-pass filter 78 , which prevents aliasing. Filter 78 passes filtered measurements 92 to analog-to-digital converter 80 , which converts filtered analog measurements 92 to digital measurement data 94 . Processor 82 receives digital measurement data 94 . Digital measurement data 94 may be stored in random access memory (RAM) 84 . [0043] Based upon digital measurement data 94 , processor 82 evaluates the carbon dioxide concentration in the patient's breath over time. Processor 82 may, for example, construct tracings such as tracings 22 or 32 shown in FIG. 2, and derive triangles such as triangles 40 or 50 . Processor 82 may find quantities such as duration of the rise of carbon dioxide concentration or take-off angle. Using quantities such as these, processor 82 may determine whether the data support a diagnosis of obstructive lung disease or restrictive lung disease. [0044] Processor 82 may, for example, measuring the duration of a steady rise of the concentration of carbon dioxide. A long duration is indicative of obstructive lung disease and a short duration is indicative of restrictive lung disease. Accordingly, processor 82 may determine that the patient probably suffers from obstructive lung disease when the duration is longer than a threshold duration, and may determine that the patient probably suffers from restrictive lung disease when the duration is shorter than the threshold duration. [0045] In addition or in the alternative, processor 82 may measure the rate of increase of the concentration of carbon dioxide. The rate of increase may be quantified by, for example, the steepness of the hypotenuse of the ascending slope, or by the magnitude of the take-off angle, or both. Processor 82 may determine that the patient probably suffers from obstructive lung disease when the rate of increase is lower than a threshold rate, and may determine that the patient probably suffers from restrictive lung disease when the rate of increase is higher than the threshold rate. [0046] As an alternative to or in addition to this analysis, processor 82 may compare digital measurement data 94 to one or more characteristic curves. Memory such as read-only memory (ROM) 86 may store data that are characteristic of obstructive lung disease and data that are characteristic of restrictive lung disease. Processor 82 may correlate the measurements of the concentration of carbon dioxide from the patient with the characteristic curves. When the correlation exceeds a preselected threshold value, processor 82 may determine that the data support a diagnosis of obstructive lung disease or restrictive lung disease. [0047] In addition to determining whether the patient more likely suffers from obstructive lung disease or restrictive lung disease, processor 82 may also gauge the severity of the condition. Processor 82 may report a severe case of obstructive lung disease, for example, when take-off angle 48 is below a particular value, indicating that the patient has extreme difficulty pushing out his breath. Degrees of severity may also be reported, such as “critical,” “moderate” and “mild.” [0048] Processor 82 reports the results of the analysis to the health professional via input/output (I/O) device 88 . 1 / 0 device 88 may include, for example, a display screen that displays text or graphics, or a collection of light emitting diodes. Processor 82 may report an analysis, such as “Patient's exhaled carbon dioxide concentration indicates a greater likelihood of obstructive lung disease than restrictive lung disease,” or “Patient's exhaled carbon dioxide concentration indicates a high probability of obstructive lung disease.” Processor 82 may further report on the severity of the condition, and/or may display the tracing of the carbon dioxide concentration. Furthermore, processor 82 may suggest an appropriate treatment based upon the analysis. [0049] In contrast to a spirometer, system 70 may be small and easily portable. Accordingly, system 70 may be included in first aid packages in public venues such as airports and health clubs, or may be carried to the patient by an emergency medical professional. Furthermore, unlike a spirometer, system 70 may provide guidance for treatment of the patient very quickly, and need not be effort-dependent. [0050] The organization of system 70 is an example of one system that may be used to practice the invention, and the invention is not limited to the system shown. For example, digital measurement data 94 may be supplied to RAM 84 via a direct memory access module (not shown in FIG. 3), rather than via processor 82 . ROM 86 may include erasable programmable read-only memory (EPROM). I/O device 88 may be one of several input and/or output devices. The invention encompasses all of these variations. [0051] [0051]FIG. 4 is a flow diagram illustrating an embodiment of the invention in an exemplary application, such as the case of a patient suffering from a shortness of breath. System 70 receives expired breath from the patient via intake apparatus 72 ( 100 ). Gas sensor 76 measures the carbon dioxide concentration ( 102 ) and reports the measurements to processor 82 . [0052] In addition to making measurements of carbon dioxide concentration, system 70 helps in determine the nature of the condition and further helps guide treatment of the patient. In a typical application, processor 82 analyzes the measurements over time ( 104 ) using techniques such as those described above and ascertains whether the data support a determination that lung disease is present ( 106 ). When the data support a determination that obstructive lung disease is present, processor 82 may so report via I/O device 88 ( 108 ). Similarly, when the data support a determination that restrictive lung disease is present, processor 82 may so report ( 110 ). In some circumstances, the data may support neither case, and processor 82 may so report ( 112 ). [0053] Processor 82 may also report additional information ( 114 ) that may guide the treatment of the patient. For example, processor 82 may report the severity of the condition, or may suggest a medicine for the condition, or may recommend that the measurements be repeated, or may suggest that the patient be instructed to breathe in a particular manner. [0054] [0054]FIG. 5 is a flow diagram showing how the invention may be implemented to monitor the effectiveness of treatment. In some circumstances, such as treatment of some forms of asthma, proper treatment produces a prompt improvement in the condition of the patient, and this improvement can be monitored. System 70 receives expired breath from a patient via intake apparatus 72 ( 120 ), gas sensor 76 measures the carbon dioxide concentration ( 122 ) and processor 82 analyzes the measurements ( 124 ). Instead of reporting a determination of lung disease, however, processor 82 monitors changes in the condition of the patient, and reports the of the changes via I/O device 88 . In this way, the invention may be used to observe the responsiveness of the patient to treatment. [0055] Various embodiments of the invention have been described. These embodiments are illustrative of the practice of the invention. Various modifications to the apparatus or methods may be made without departing from the scope of the invention. For example, the invention need not be embodied in a standalone apparatus, but may be combined with an apparatus that performs other diagnostic or treatment functions. Similarly, the invention need not be embodied in a method that analyzes only carbon dioxide concentration in the breath, but may include other diagnostic measurements such as measurements of heart rate, respiration rate, blood pressure, electrocardiogram and blood oxygenation. [0056] Other embodiments may employ capnograms from a plurality of breaths, and may process the capnograms by techniques such as averaging. These and other embodiments are within the scope of the following claims.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of U.S. application Ser. No. 15/635,267, filed Jun. 28, 2017, which is a continuation-in-part of U.S. application Ser. No. 15/189,188, filed Jun. 22, 2016, which is a continuation-in-part of U.S. application Ser. No. 15/014,189, filed Feb. 3, 2016, which is a continuation-in-part of U.S. application Ser. No. 14/109,429, filed Dec. 17, 2013, now U.S. Pat. No. 9,370,434, which is a divisional of U.S. patent application Ser. No. 12/875,818, filed Sep. 3, 2010, now U.S. Pat. No. 8,632,595, the entire disclosures of which are incorporated herein by reference in their entireties for all purposes. FIELD OF THE INVENTION [0002] The present disclosure is generally directed to surgical devices, systems, and methods. More particularly, the present disclosure is directed to expandable interspinous process fixation devices, systems, and methods. BACKGROUND [0003] A spine comprises vertebrae which are a series of small bones, and also includes spinous processes. A spinous process is one of two bony protrusions arising from the posterior side of each vertebra in the human spine. Extending backwards and downwards from the main body of the vertebra, each spinous process is an extension of the lamina. The laminae are two bony plates that converge at the back of each vertebra to form the vertebral arch. The spinous processes curve outward from this junction. A variety of scenarios may exist where damage to the spine may occur including, but not limited to, injury or illness. Severe, even debilitating, pain can result from such damage. In some instances, artificial assistance may be necessary to address such damage. [0004] Surgical procedures exist that attempt to address such damage including using various vertebral fixation devices. Conventional devices exist to implant vertebrae fixation devices, but such devices often suffer from the problem of being purely manual and are usually complex. Such manual devices require the use of human muscle, which can fatigue, to perform the procedure. Moreover, the incision opening for insertion of these fixation devices may require substantial openings to achieve access to the spinous process. [0005] There are drawbacks associated with the known conventional fixation devices and methodologies. For example, present methods for installing a conventional fixation device often require that the adjacent vertebral bodies be distracted to restore a diseased disc space to its normal or healthy height prior to implantation of the fixation device. In order to maintain this height once the fixation device is inserted, the fixation device is usually dimensioned larger in height than the initial distraction height. This difference in height can make it difficult for a surgeon to install the fixation device in the distracted intervertebral space. [0006] As such, there exists a need for a fixation device capable of being installed inside an intervertebral disc space at a minimum to no distraction height and for a fixation device that can maintain a normal distance between adjacent vertebral bodies when implanted. SUMMARY [0007] To meet this and other needs, devices, systems, and methods of fixation are provided. The fixation devices and systems may include expandable interspinous process fixation devices and system and associated method of implantation. [0008] In at least one embodiment, the present disclosure provides an expandable interspinous process fixation system which is a posterior, non-pedicle supplemental fixation device. In some embodiments, the interspinous process fixations system may be intended for use in the non-cervical spine. The interspinous process fixations system may attach firmly to adjacent spinous processes and immobilize a lumbar motion segment posteriorly. The device may be configured to withstand compressive, torsional, and shear loads seen in the lumbar spine. The device is intended to achieve supplemental fusion, treating various conditions, for example, degenerative disc disease; spondylolisthesis; trauma (i.e., fracture or dislocation); tumor; and/or other conditions. [0009] In at least one embodiment, a device according to the present disclosure allows for insertion of a spinous process fixation implant at a reduced height and then an increase of the height after insertion to achieve an accurate anatomical fit. Adjustability of the implant greatly reduces the complexity of inserting an interspinous device since one device covers a wide range of implant sizes, negating the need for several variations of implant lengths and widths. The implant may be preassembled, greatly reducing the number of steps required to insert the device, which simplifies the overall procedure and reduces operating room time. [0010] In at least one embodiment, the present disclosure provides a fixation device including first and second endplates for an intervertebral implant. The first endplate has a first lateral adjustment arm extending from a first edge thereof and the second endplate has a second lateral adjustment arm extending from a first edge thereof. A first fixed plate extends along a second edge of the first endplate opposite the first edge thereof. The first fixed plate extends substantially perpendicular to the first endplate and has an inner surface defining a first spinous process engaging surface. A second fixed plate extends along a second edge of the second endplate opposite the first edge thereof. The second fixed plate extends substantially perpendicular to the second endplate and has an inner surface defining a second spinous process engaging surface. A first sliding plate is adjustably mounted on the first lateral adjustment arm such that the first sliding plate extends substantially perpendicular to the first endplate and has an inner surface defining a third spinous process engaging surface. A second sliding plate is adjustably mounted on the second lateral adjustment arm such that the second sliding plate extends substantially perpendicular to the second endplate and has an inner surface defining a fourth spinous process engaging surface. An expansion assembly is positioned between the first and second endplates and is configured to selectively cause the first and second endplates to move apart. [0011] In at least one embodiment, the present disclosure provides a method including: inserting an expandable fixation device into an intervertebral disc space, wherein the expandable fixation device includes: a first endplate for an intervertebral implant, the first endplate having a first lateral adjustment arm extending from a first edge thereof; a second endplate for an intervertebral implant, the second endplate having a second lateral adjustment arm extending from a first edge thereof a first fixed plate extending along a second edge of the first endplate opposite the first edge thereof, the first fixed plate extending substantially perpendicular to the first endplate and having an inner surface defining a first spinous process engaging surface; a second fixed plate extending along a second edge of the second endplate opposite the first edge thereof, the second fixed plate extending substantially perpendicular to the second endplate and having an inner surface defining a second spinous process engaging surface; a first sliding plate adjustably mounted on the first lateral adjustment arm such that the first sliding plate extends substantially perpendicular to the first endplate and has an inner surface defining a third spinous process engaging surface; a second sliding plate adjustably mounted on the second lateral adjustment arm such that the second sliding plate extends substantially perpendicular to the second endplate and has an inner surface defining a fourth spinous process engaging surface; an expansion assembly positioned between the first and second endplates; the expansion assembly configured to selectively cause the first and second endplates to move apart; actuating the expansion assembly to cause movement of the first and the second endplates away from one another; adjusting the lateral position of the first sliding plate such that spinous processes are compressed between the first and third spinous process engaging surfaces and thereafter fixing the position of the first sliding plate; and adjusting the lateral position of the second sliding plate such that spinous processes are compressed between the second and fourth spinous process engaging surfaces and thereafter fixing the position of the second sliding plate. [0012] Additional features, advantages, and aspects of the present disclosure may be set forth or apparent from consideration of the following detailed description, drawings, and claims. Moreover, it is to be understood that both the foregoing summary of the present disclosure and the following detailed description are exemplary and intended to provide further explanation without limiting the scope of the present disclosure as claimed. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The accompanying drawings, which are included to provide a further understanding of the present disclosure, are incorporated in and constitute a part of this specification, illustrate aspects of the present disclosure and together with the detailed description serve to explain the principles of the present disclosure. No attempt is made to show structural details of the present disclosure in more detail than may be necessary for a fundamental understanding of the present disclosure and the various ways in which it may be practiced. In the drawings: [0014] FIG. 1 is a perspective view of the expandable fixation device in accordance with one embodiment of the present disclosure shown in an unexpanded position; [0015] FIG. 2 is a front elevation view of the expandable fixation device of FIG. 1 in the unexpanded position; [0016] FIG. 3 is an exploded perspective view of the expandable fixation device of FIG. 1 ; [0017] FIG. 4 is a left side view of the expandable fixation device of FIG. 1 in the unexpanded position; [0018] FIG. 5 is a right side view of the expandable fixation device of FIG. 1 in the unexpanded position; [0019] FIG. 6 is a perspective view of the expandable fixation device of FIG. 1 shown in an expanded position; [0020] FIG. 7 is a front elevation view of the expandable fixation device of FIG. 1 in the expanded position; [0021] FIG. 8 is a left side view of the expandable fixation device of FIG. 1 in the expanded position; [0022] FIG. 9 is a right side view of the expandable fixation device of FIG. 1 in the expanded position; [0023] FIG. 10 is a perspective view of the expandable fixation device in accordance with another embodiment of the present disclosure shown in an expanded position; [0024] FIG. 11 is an exploded perspective view of the expandable fixation device of FIG. 10 ; [0025] FIG. 12 is a left side view of the expandable fixation device of FIG. 10 in an unexpanded position; [0026] FIG. 13 is a right side view of the expandable fixation device of FIG. 10 in the unexpanded position; [0027] FIG. 14 is a right side view of the expandable fixation device of FIG. 10 in an intermediate position; [0028] FIG. 15 is a left side view of the expandable fixation device of FIG. 10 in the expanded position; and [0029] FIG. 16 is a right side view of the expandable fixation device of FIG. 10 in the expanded position. DETAILED DESCRIPTION [0030] The aspects of the present disclosure and the various features and advantageous details thereof are explained more fully with reference to the non-limiting aspects and examples that are described and/or illustrated in the accompanying drawings and detailed in the following description. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one aspect may be employed with other aspects as the skilled artisan would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the aspects of the present disclosure. The examples used herein are intended merely to facilitate an understanding of ways in which the present disclosure may be practiced and to further enable those of skill in the art to practice the aspects of the present disclosure. Accordingly, the examples and aspects herein should not be construed as limiting the scope of the present disclosure, which is defined solely by the appended claims and applicable law. Moreover, it is noted that like reference numerals represent similar parts throughout the several views of the drawings. [0031] Surgical intervention for back pain may occur for people with chronic back pain, perhaps for which other treatments have failed. Surgery may be required, for example, for people who have chronic lower back pain and sciatica (often diagnosed with a herniated disc), spinal stenosis, spondylolisthesis (vertebra of the lumbar spine slips out of place), vertebral fractures with nerve involvement, or other indications as assessed by a medical professional. Also, surgery may be necessary for people with discogenic lower back pain (e.g., degenerative disc disease) that may occur as part of the aging process. In these situations, among others, implants may be included in a course of treatment. Generally, the goal may be to achieve supplemental fusion or complete fusion of the spine. [0032] With reference to FIGS. 1-9 , an embodiment of the fixation device 10 is shown. In the exemplary embodiment, the fixation device 10 includes a first endplate 20 , a second endplate 40 , first and second fixed plates 60 , 70 , a pair of sliding plates 80 , 90 , a central ramp 110 , and a driving ramp 130 . [0033] Each of the endplates 20 , 40 includes a body 22 , 42 extending between opposed ends 21 , 23 ; 41 , 43 . In the illustrated embodiment, each endplate body 22 , 42 defines an outer surface 24 , 44 connecting the first end 21 , 41 and the second end 23 , 43 , and an inner surface 26 , 46 connecting the first end 21 , 41 and the second end 23 , 43 . In an embodiment, each endplate 20 , 40 defines a through opening 25 , 45 . The through openings 25 , 45 , in an exemplary embodiment, are sized to receive bone graft or similar bone growth inducing material and further allow the bone graft or similar bone growth inducing material to be packed in a central area of the device 10 . [0034] The outer surface 24 , 44 of each endplate 20 , 40 may be flat and generally planar to allow the outer surface 24 , 44 of the endplate 20 , 40 to engage with an adjacent vertebral body. Alternatively, one or both of the outer surfaces 24 , 44 can be curved convexly or concavely to allow for a greater or lesser degree of engagement with the adjacent vertebral body. It is also contemplated that the outer surfaces 24 , 44 can be generally planar but include a generally straight ramped surface or a curved ramped surface, angled, or otherwise configured. The presence of one or more ramped surfaces may allow for engagement with the adjacent vertebral body in a lordotic fashion. While not illustrated, in an exemplary embodiment, one or both outer surfaces 24 , 44 may include texturing or other surface features to aid in gripping the adjacent vertebral bodies. Although not limited to the following, the texturing or other surface features can include teeth, ridges, friction increasing elements, keels, gripping or purchasing projections, or the like. [0035] Referring to FIGS. 3, 5 and 9 , the inner surface 26 of the first endplate 20 defines a first pair of spaced apart extensions 30 at the first end 21 of the body 22 and a second pair of spaced apart extensions 34 at the second end 23 of the body. The extensions 30 at the first end 21 are positioned oppositely of the extensions 34 at the second end 23 , e.g., on the first end 21 , the extension 30 on the right side is at the edge while the extension on the left side is inward of the edge and on the second end 23 , the extension 34 on the right side is inward of the edge while the extension on the left side is at the edge. Similarly, the inner surface 46 of the second endplate 40 defines a first pair of spaced apart extensions 50 at the first end 41 of the body 42 and a second pair of spaced apart extensions 54 at the second end 43 of the body. With the second endplate 40 , the extensions 50 , 54 are opposite of those on the first plate 20 i.e. on the first end 41 , the extension 50 on the right side is inward from the edge while the extension on the left side is at the edge and on the second end 43 , the extension 54 on the right side is at the edge while the extension on the left side is inward of the edge. With this configuration, the extensions 30 of the first endplate 20 overlap the extensions 50 of the second endplate 40 and the extensions 54 of the second endplate 40 overlap the extensions 34 of the first endplate 20 . [0036] Each of the extensions 30 , 34 , 50 , 54 defines a respective ramped surface 31 , 35 , 51 , 55 . The ramped surfaces 31 , 35 , 51 , 55 are configured to be engaged by ramped surfaces on the central ramp 110 and the driving ramp 130 , as will be described hereinafter. Each of the extensions 30 , 34 , 50 , 54 also defines a respective groove 33 , 37 , 53 , 57 . The grooves 33 , 37 , 53 , 57 are configured to be engaged by projections on the central ramp 110 and the driving ramp 130 to maintain the device 10 in an assembled condition and to guide movement of the endplates 20 , 40 , as will be described hereinafter. [0037] Each endplate 20 , 40 includes a fixed plate 60 , 70 attached along one side edge of the body 22 , 42 . Each fixed plate 60 , 70 of the illustrated embodiment includes a body 62 , 72 extending from a fixed end 61 , 71 to a free end 63 , 73 . The fixed plate bodies 62 , 72 may have any desired shape to complement the intended engagement with respective spinous processes, and may be mirror images of one another or may be distinct from one another. The inner surface 64 , 74 of each fixed plate 60 , 70 includes a plurality of spikes 66 , 76 or the like to grip the spinous processes when engaged therewith. The outer surface of each fixed plate may include a blind bore 67 , 77 , through bore or the like. The bores 67 , 77 , in an exemplary embodiment, are sized to receive bone graft or similar bone growth inducing material. [0038] A lateral adjustment bar 28 , 48 extends outwardly from the opposite side edge of the body 22 , 42 of each end plate 20 , 40 to a free end 29 , 49 . The adjustment bars 28 , 48 support respective sliding plates 80 , 90 . Each sliding plate 80 , 90 of the illustrated embodiment includes a body 82 , 92 extending from a connection end 81 , 91 to a free end 83 , 93 . The sliding plate bodies 82 , 92 may have any desired shape to complement the intended engagement with respective spinous processes, and may be mirror images of one another or may be distinct from one another. The inner surface 84 , 94 of each fixed plate 80 , 90 includes a plurality of spikes 86 , 96 or the like to grip the spinous processes when engaged therewith. The outer surface of each fixed plate may include a blind bore 87 , 97 , through bore or the like. The bores 87 , 97 , in an exemplary embodiment, are sized to receive bone graft or similar bone growth inducing material. [0039] The connection end 81 , 91 of each sliding plate 80 , 90 includes a connection assembly 88 , 98 which allows the sliding plate 80 , 90 to be mounted on a respective lateral adjustment bar 28 , 48 such that the sliding plate 80 , 90 is laterally adjustable but rotationally fixed. In the illustrated embodiment, each connection assembly 88 , 98 defines a receiving bore 85 , 95 extending laterally through the body 82 , 92 and configured to receive the respective lateral adjustment bar 28 , 48 . The receiving bores 85 , 95 and the lateral adjustment bars 28 , 48 have complementary shapes which allow lateral adjustment but prevent relative rotation. In the illustrated embodiment, the receiving bores 85 , 95 and lateral adjustment bars 28 , 48 have complementary rounded rectangle shapes, but other non-circular shapes are possible. [0040] To set the position of the sliding plate 80 , 90 along the respective lateral adjustment bar 28 , 48 , a set screw 100 extends into a through bore 89 , 99 defined in the respective connection assembly 88 , 98 and intersects with the receiving bore 85 , 95 . Each set screw 100 includes a threaded portion 102 and a driving head 104 with an engagement end 103 extending toward the receiving bore 85 , 95 . The threaded portion 102 is configured to engage threads within the through bore 89 , 99 . A retaining ring 105 or the like may be positioned about each set screw 100 and engage a groove within the through bore 89 , 99 to retain the set screw 100 with the through bore 89 , 99 after assembly. Once the sliding plate 80 , 90 is positioned at a desired lateral position along the respective lateral adjustment bar 28 , 48 , the set screw 100 is threadably advanced such that the engagement end 103 engages the lateral adjustment bar 28 , 48 and fixes the sliding plate 80 , 90 relative to the respective endplate 20 , 40 . [0041] The central ramp 110 includes a body 112 extending from a first end 111 to a second end 113 . A through bore 114 extends through the body 112 from the first end 111 to the second end 113 and is configured to receive a drive screw 120 therethrough. The drive screw 120 has a threaded portion 122 and drive head 124 . A flat washer 126 and a drag reducing washer 128 may be positioned within the through bore 114 between the drive head 124 and an internal shoulder defined within the through bore 114 (not show) to facilitate driving of the central ramp while minimizing drag. Notches 119 or the like may be defined along the central ramp body 112 configured for engagement with a delivery/positioning tool (not shown) or the like. [0042] The second end 113 of the central ramp 110 defines a first pair of ramps 116 and a second pair of ramps 117 . The first ramps 116 are aligned with and configured to slidably engage the ramps 31 on the first endplate 20 . The second ramps 117 are aligned with and configured to engage the ramps 51 on the second end plate 40 . Projections 118 adjacent the ramps 116 extend into the grooves 33 on the first endplate 20 while projection adjacent to the ramps 117 (not shown) extend into the grooves 53 on the second endplate 40 . Engagement between the projections 118 and grooves 33 , 53 maintains the central ramp 110 assembled to the endplates 20 , 40 and guides movement of the endplates 20 , 40 as the central ramp 110 is advanced. [0043] The driving ramp 130 includes a ramp body 132 and a screw receiving portion 134 . A threaded blind bore 139 extends into the screw receiving portion 134 and is configured to receive the threaded portion 122 of the drive screw 120 . As such, rotation of the drive screw 120 in the advancement direction causes the central ramp 110 and the driving ramp 130 to move toward one another. [0044] The ramp body 132 of the driving ramp 130 defines a pair of first ramps 136 and a pair of second ramps 137 (see FIG. 3 ). The first ramps 136 are aligned with and configured to slidably engage the ramps 55 on the second endplate 40 . The second ramps 137 are aligned with and configured to engage the ramps 35 on the first end plate 20 . Projections 138 adjacent the ramps 136 extend into the grooves 57 on the second endplate 40 while projections 138 adjacent to the ramps 137 extend into the grooves 37 on the first endplate 20 . Engagement between the projections 138 and grooves 37 , 57 maintains the driving ramp 130 assembled to the endplates 20 , 40 and guides movement of the endplates 20 , 40 as the driving ramp 130 is advanced. [0045] Having generally described the components of the fixation device 10 , operation thereof will generally be described. The fixation device 10 may be inserted at its fully collapsed height as illustrated in FIGS. 1, 2, 4 and 5 to allow for easy insertion into a collapsed interspinous space. During insertion, the spikes 66 , 76 of the fixed plates 60 , 70 may be compressed into the respective spinous processes. After insertion, the fixation device 10 may be expanded by rotating the drive screw 120 in an advancement direction. As the drive screw 120 is rotated, the central ramp 110 and driving ramp 130 are drawn toward one another, with the ramps 31 riding up the ramps 116 , the ramps 51 riding up the ramps 117 , the ramps 35 riding up the ramps 137 , the ramps 55 riding up the ramps 136 . Such movement causes the endplates 20 , 40 to move away from one another, thereby increasing the height of the fixation device 10 to get the desired fit, or used to distract the interspinous space to relieve pressure on neurological elements. As the endplates 20 , 40 move away from one another, the fixed plates 60 , 70 and sliding plates 80 , 90 move in conformity therewith. After expansion of the endplates 20 , 40 , the sliding plates 80 , 90 are moved along the lateral adjustment bars 28 , 48 and compressed onto the spinous processes. Once positioned, the sliding plates 80 , 90 are locked into position using the set screws 100 . [0046] Referring to FIGS. 10-16 , another embodiment of the fixation device 10 ′ is shown. The fixation device 10 ′ of the present exemplary embodiment is similar to the fixation device 10 of the previous embodiment and includes a first endplate 20 ′, a second endplate 40 ′, first and second fixed plates 60 , 70 , a pair of sliding plates 80 , 90 , a central ramp 110 ′, and a driving ramp 130 ′. Only the differences between the embodiments will be described. Otherwise, the fixation devices 10 , 10 ′ operate is substantially the same manner. [0047] In the present embodiment, the endplates 20 ′ and 40 ′ and the central ramp 110 ′ are configured to cause pivoting between the endplates 20 ′, 40 ′ prior to expansion thereof. As in the previous embodiment, each endplate 20 ′, 40 ′ includes a body 22 ′, 42 ′ extending from a first end 21 ′, 41 ′ to a second end 23 ′, 43 ′. Referring to FIG. 14 , in the present embodiment, the first ends 21 ′, 31 ′ do not include extensions, but instead have a tapered end surface which defines the ramps 31 ′ 51 ′. The second ends 23 ′, 43 ′ are similar to the previous embodiment and include extensions 34 ′, 54 ′ defining the ramps 35 , 55 . The extensions 34 ′ 54 ′ also define inward ramps 36 , 56 . Inward of the extensions 34 , 54 , each endplate body 22 ′, 44 ′ defines a retaining notch 29 , 49 . The retaining notches 29 , 49 are configured to be engaged by an inward end 113 ′ of the central ramp 110 ′ and prevent inward advancement of the central ramp 110 ′ until the endplates 20 ′ 40 ′ have pivoted relative to one another. [0048] The central ramp 110 ′ includes a body 112 ′ extending from a first end 111 ′ to a second end 113 ′ with the body 112 ′ having a longer length compared to the central ramp body 112 of the previous embodiment. A through bore 114 extends through the body 112 ′ from the first end 111 ′ and is configured to receive the drive screw 120 therethrough. The first end 111 ′ of the central body 110 ′ defines ramps 116 ′ and 117 ′. The ramps 116 ′ and 117 ′ are configured to engage the ramps 31 ′ and 51 ′, respectively. [0049] The second end 113 ′ of the central ramp 110 defines a pair of extensions 123 on a first surface thereof and a pair of extensions 125 on the opposite surface. The extensions 123 are aligned with and configured to be received in the notches 29 defined by the first endplate 20 ′ and the extensions 125 are aligned with and configured to be received in the notches 49 defined by the second endplate 40 ′ (see FIG. 13 ). The extensions 123 also define forward ramps 127 while the extensions 125 define forward ramps 129 . [0050] The driving ramp 130 ′ includes a ramp body 132 ′ and a screw receiving portion 134 ′. The screw receiving portion 134 ′ is shorter in length than in the previous embodiment. A threaded blind bore 139 extends into the screw receiving portion 134 ′ and is configured to receive the threaded portion 122 of the drive screw 120 . [0051] The ramp body 132 ′ of the driving ramp 130 ′ defines a pair of ramps 136 ′ aligned with and configured to slidably engage the ramps 55 on the second endplate 40 ′. The ramp body 132 ′ also defines a pair of ramps 137 ′ which are aligned with and configured to engage the ramps 35 on the first end plate 20 ′. Projections 138 ′ adjacent the ramps 136 ′, 137 ′ extend into the grooves 37 , 57 on the endplates 20 ′, 40 ′. Engagement between the projections 138 ′ and grooves 37 , 57 maintains the driving ramp 130 ′ assembled to the endplates 20 ′, 40 ′ and guides movement of the endplates 20 ′, 40 ′ as the driving ramp 130 ′ is advanced. [0052] Having generally described the components of the fixation device 10 ′, operation thereof will generally be described with reference to FIGS. 12-16 . The fixation device 10 ′ may be inserted at its fully collapsed height as illustrated in FIGS. 12 and 13 to allow for easy insertion into a collapsed interspinous space. As illustrated, in the collapsed position, the extensions 123 and 125 are positioned in the respective notches 29 , 49 . During insertion, the spikes 66 , 76 of the fixed plates 60 , 70 may be compressed into the respective spinous processes. After insertion, the angular relation between the endplates 20 ′, 40 ′ is adjusted by rotating the drive screw 120 in an advancement direction. During initial advancement of the drive screw 120 , engagement of the extensions 123 , 125 in the notches 29 , 49 prevents the central ramp 110 ′ from advancing. Only the driving ramp 130 ′ is able to advance. As the driving ramp 130 ′ advances, the ramps 35 ride up the ramps 136 ′ and the ramps 55 ride up the ramps 137 ′. As illustrated in FIG. 14 , such causes the endplates 20 ′, 40 ′ to pivot relative to one another with the ends 23 ′ and 43 ′ moving away from one another. Once the endplates 20 ′, 40 ′ have pivoted a maximum amount ( FIG. 14 ), the extensions 123 , 125 are clear of the notches 29 , 49 . As such, with continued rotational advancement of drive screw 120 , the central ramp 110 ′ is free to move toward the driving ramp 130 ′, with the central ramp 110 ′ and the driving ramp 130 ′ drawn to one another, with the ramps 31 ′ riding up the ramps 116 ′, the ramps 51 ′ riding up the ramps 117 ′, the ramps 35 riding up the ramps 136 ′, the ramps 55 riding up the ramps 137 ′, and the forward ramps 127 , 129 riding along the inward ramps 36 , 56 , as illustrated in FIGS. 15 and 16 . Such movement causes the endplates 20 ′, 40 ′ to move away from one another, thereby increasing the height of the fixation device 10 to get the desired fit, or used to distract the interspinous space to relieve pressure on neurological elements. As the endplates 20 ′, 40 ′ pivot and then move away from one another, the fixed plates 60 , 70 and sliding plates 80 , 90 move in conformity therewith. After expansion of the endplates 20 ′, 40 ′, the sliding plates 80 , 90 are moved along the lateral adjustment bars 28 , 48 and compressed onto the spinous processes. Once positioned, the sliding plates 80 , 90 are locked into position using the set screws 100 . [0053] The expandable fixation devices 10 , 10 ′ may be manufactured from a number of suitable biocompatible materials including, but not limited to, titanium, stainless steel, titanium alloys, non-titanium metallic alloys, polymeric materials, plastics, plastic composites, PEEK, ceramic, elastic materials, or other suitable biocompatible materials. [0054] In an exemplary embodiment, bone graft or similar bone growth inducing material can be introduced around and/or within the fixation device 10 , 10 ′ to further promote and facilitate the intervertebral fusion. The fixation device 10 , 10 ′, in one embodiment, is preferably packed with bone graft or similar bone growth inducing material to promote the growth of bone through and around the fixation device. Such bone graft may be packed between the endplates of the adjacent vertebral bodies prior to, subsequent to, or during implantation of the fixation device. [0055] Some advantages of the devices described in this disclosure are the ability to insert a spinous process fusion implant at a reduced height and then increase the height after insertion to achieve an accurate anatomical fit. Since the size of the implant is adjustable, it also greatly reduces the complexity of inserting an interspinous device since one device covers a wide range of implant sizes, negating the need for several variations of implant lengths and widths. The implant may be preassembled, greatly reducing the number of steps required to insert the device, which simplifies the overall procedure and reduces operating room time. [0056] While the present disclosure has been described in terms of exemplary aspects, those skilled in the art will recognize that the present disclosure can be practiced with modifications in the spirit and scope of the appended claims. These examples given above are merely illustrative and are not meant to be an exhaustive list of all possible designs, aspects, applications or modifications of the present disclosure.

1a

FIELD OF THE INVENTION [0001] The present invention relates to methods of making edible food containers, and more particularly, to a method for making an edible packaging container comprising fermentable wheat flour. BACKGROUND OF THE INVENTION [0002] Following a healthy diet is one of the most important things modern people can do to help maintain their overall health. Along with physical activity, the diet is the key factor that affects weight. Being overweight or obese increases risks of heart disease and many other diseases. Fortunately, nowadays, people are becoming more conscious of the importance of keeping fit and living healthy. In order to maintain a healthy diet, it is necessary to choose modes of cooking that are good for the health. Modes like barbecuing and frying at high temperature adversely affect valuable nutrients and often utilize too much oil. It has been well established that such processing may easily lead to weight gain, artery-vein and heart diseases, and damage to the metabolic system. Consequently, healthier modes of cooking such as water steaming are being favored. In particular, food made of fermentable flour cooked by water steaming has become a mainstream, as it is easy to digest and filling. [0003] Food made of fermentable flour is often divided into two kinds: one made without fillings and one made with fillings stuffed therein. However, food, such as bread, made without fillings is often perceived to lack variety in flavor. And food made with fillings and then cooked by steam does not permit consumers to change the fillings as desired. Therefore, fermentable flour type foods having fillings that can be conveniently changed and that can be eaten directly without cooking, such as the so-called Chinese-Hamburger, have become increasingly popular among consumers. [0004] FIGS. 1A to 1 C illustrate a common method of producing a conventional Chinese-Hamburger. As depicted in FIG. 1A , an oval-shaped batter 100 is first formed for making a batter cover. Then, as shown in FIG. 1B , the surface of the oval-shaped batter 100 is coated with an edible oil to form an oil layer region 110 thereon. Lastly, as shown in FIG. 1C , the oval-shaped batter 100 is folded by turning the oil layer region 110 inwardly, resulting in-after cooking-a batter cover 110 ′ formed with an interior space or opening 150 for fillings that is open on three sides and closed at the fold. However, such a batter cover having an opening with only one closed side can easily expose and drop the fillings that are stuffed therein, as shown in FIG. 2 , making it inconvenient to carry or eat. Therefore, it is desirable to develop an edible food container that is convenient to stuff fillings therein and is easy to eat and carry. SUMMARY OF THE INVENTION [0005] A primary objective of the present invention is to provide a method of producing an edible packaging container that retains stuffed fillings while eating or carrying. [0006] Another primary objective of the present invention is to provide a method of producing an edible packaging container that is applicable to mass production. [0007] To achieve the above and other objectives, the present invention proposes a method of producing an edible packaging container, comprising the steps of: (a) preparing a kneaded batter; (b) forming an oil-layer region on the center portion of one side of the batter and a water-moisturizing region on the periphery of one side of the batter; (c) folding the batter by turning the oil-layer region thereof inwardly, and combining a portion of the batter by machinery to form the edge comprising the water-moisturizing region; and (d) cooking the batter by steaming and cutting along the folded lines to form a pocket-shaped container. The edible pocket container is produced by forming an oil-layer region and a water-moisturizing region at predetermined positions of the batter surface, enabling the edible pocket container to be made by machinery in mass production rather than by hand using the fingers to roll up the batter, thereby achieving the goal of mass production of the edible pocket container. [0008] The present invention further discloses a method of producing an edible container, comprising the steps of: (a) preparing two pieces of identically-shaped batters; (b) forming an oil-layer region in the center portion and one edge of one side of each of the batters, and forming a water-moisturizing region on each of the remaining edges of one side of each of the batters; (c) folding up the two batters such that the oil-layer regions thereof are facing, and kneading a portion of the batters by machinery to form the edges comprising the water-moisturizing regions; and (d) cooking the folded batters by steaming to form an edible pocket-shaped container. BRIEF DESCRIPTION OF THE DRAWINGS [0009] The method of producing an edible packaging container of the present invention can be fully understood by reading the following detailed description of the preferred embodiments, with reference made to the accompanying drawings, wherein: [0010] FIGS. 1A to 1 C (PRIOR ART) are perspective views showing the steps of producing a conventional batter cover for a Chinese-Hamburger; [0011] FIG. 2 (PRIOR ART) is a perspective view showing a conventional batter cover for a Chinese-Hamburger stuffed with fillings; [0012] FIGS. 3A to 3 D are perspective views showing the steps of making a first preferred embodiment of the present invention; [0013] FIGS. 4A and 4B are perspective views showing the method of producing an edible packaging container in accordance with the present invention; [0014] FIGS. 5A to 5 D are perspective views showing the steps of making a second preferred embodiment of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT [0015] The present invention is described in the following so that one skilled in the pertinent art can easily understand other advantages and effects of the present invention. The present invention may also be implemented and applied according to other embodiments, and the details may be modified based on different views and applications without departing from the spirit of the invention. [0016] FIGS. 3A to 3 D depict a first preferred embodiment of the present invention; which is made by first kneading a combination of mixed ingredients that includes wheat flour, sugar, oil, powder, yeast, water and likely others to form a smooth and even batter having an appropriate elasticity. Next, the kneaded batter is put aside and left for about ten to twenty minutes to become loose. Then, the batter is cut into a plurality of small batters and each of the plurality of small batters is rolled into an oval-shaped batter 300 as depicted in FIG. 3A . Thereafter, an edible type of oil is applied to the surface of the center portion of the oval-shaped batter to form an oil-layer region 310 . Filtered water is then sprayed by a spray nozzle on the surface of the periphery of the oval-shaped batter surface 300 to form an even water-moisturizing region 330 as shown by FIG. 3B . Subsequently, the oval-shaped batter is folded by turning the oil layer region inwardly to form a folded batter layer 300 ′ having a hemispherical shape. Then, referring to FIG. 3C , the folded batter layer 300 ′ is kneaded by machinery along the edge shown by the vertical arrows A, avoiding the center portion having an oil layer region 310 , to form an edge having a water-moisturizing region 330 , thereby forming a semi-finished flour-yeasted packaging container. Then, the semi-finished flour-yeasted packaging container is placed into a yeast tank to undergo a yeast fermentation process for twenty to forty minutes, followed by placement in a steaming cage to steam for about fifteen minutes at a temperature of about 90 degrees. Lastly, as shown by FIG. 3D , the packaging container is cut along the folding line 350 to form an opening 370 . [0017] In that the center portion of the folded batter layer 300 ′ is formed with an oil layer region and is not pressed during kneading after the batter is folded, the center portion of the folded batter layer 300 ′ having an oil layer region is not combined and thus has a hollow gap between the upper layer and the lower layer thereof after cooking the semi-finished packaging container by steam. On the other hand, the edge of the folded batter layer between the upper layer and the lower layer thereof is formed with a water-moisturizing area by spraying filtered water thereon and is combined by kneading by machinery, therefore, after cooking the semi-finished packaging container by steam, the edge of the folded batter layer having a water-moisturizing region is combined to form a sealed side 390 as shown in FIG. 4A . [0018] Thereafter, after cutting along the folded side, a pocket-shaped container is formed that has only one side thereof formed with an opening 370 , while the remaining edges are sealed to form a hollow portion for packaging fillings therein as shown by FIG. 4B . In this embodiment, the pocket-shaped container is used as a cover for making a Chinese-Hamburger, wherein the fillings to be filled into the central hollow portion of the Chinese-Hamburger such as meat slices, pickled cabbage, peanut powder and the like-can be inserted into the pocket container through the opening 370 . Compared to the known batter cover used for making a Chinese-Hamburger that typically has one closed side with the remaining sides open, the edible pocket container disclosed by the invention is provided with a hollow pocket to contain the fillings therein, making it more convenient to eat or carry. Moreover, the pocket container is characterized in that an oil-layer region and a water-moisturizing region are respectively formed at predetermined positions of the batter surface, thereby overcoming the drawback of the prior art that the edible container is not readily applicable to mechanized mass production. [0019] FIGS. 5A to 5 D depict a second preferred embodiment of the present invention; which is made by first kneading a combination of mixed ingredients that includes wheat flour, sugar, oil, powder, yeast, water and likely others to form a smooth and even batter having an appropriate elasticity. Next, the batter is put aside and left for about ten to twenty minutes to become loose. Then, the batter is cut into a plurality of small batters and each of the plurality of small batters is rolled into a hemisphere-shaped batter 400 , as depicted in FIG. 5A . Thereafter, referring to FIGS. 5B and 5C , an edible type of oil is applied to the surface of the center portion and the non-arc-shaped (linear) side 450 of the hemisphere-shaped batters to form an oil-layer region 410 , and filtered water is sprayed by a spray nozzle on the surface 400 of the arc-shaped edges of the hemisphere-shaped batters to form an even water-moisturizing region 430 . Subsequently, two identical hemisphere-shaped batters are placed together by facing the oil layer regions thereof to form a superposed batter layer 400 ′ retaining the hemispherical shape, as shown in FIG. 5C . Then, the superposed batter layer 400 ′ is kneaded by machinery along the arc-shaped edge as indicated by the vertical arrows A, avoiding pressing the center portion having an oil layer region 410 , to form an edge having a water-moisturizing region 430 , thereby forming a semi-finished yeasted flour packaging container. Then, the semi-finished yeasted flour packaging container is placed into a yeast tank to undergo a yeast process for twenty to forty minutes, followed by placement of the yeasted flour container in a steaming cage to steam at a temperature of about 90 degrees for about fifteen minutes [0020] Reviewing, an oil layer region is respectively formed on the inner center portion and the edges of the non-arc-shaped (linear) side of the superposed batter layer 400 ′ and a water-moisturizing region is formed on the arc-shaped edges thereof. The center portion thereof having an oil-layer is not pressed to combine after the superposed batters are folded by machinery. Consequently, after cooking the semi-finished packaging container by steam, the center portion having an oil layer region and the non-arc-shaped side of the superposed batter layer 400 ′ are not combined and thus a hollow gap exists between the upper layer and the lower layer thereof. On the other hand, the arc-shaped edge of the superposed batter layer having a water-moisturizing area between the upper layer and the lower layer thereof is kneaded to combine by machinery to form a sealed side 490 as indicated by FIG. 5D . Note that only the periphery of the arc-shaped edge is formed with a water-moisturizing region in this embodiment. Also, in addition to the center portion that has an oil-layer region, the non-arc-shaped (linear) edges of the hemisphere-shaped superposed batter layers are also formed with an oil-layer region. Therefore, after kneading by machinery to combine the hemisphere-shaped superposed batter layers, a yeast fermentation process, and cooking by steam, an edible hemisphere-shaped container is formed with a center hollow pocket that has only one edge formed with an opening 470 without requiring a cutting process while the remaining edges are sealed. [0021] Besides the hemisphere-shaped pocket container, the method of producing an edible container disclosed by the invention can also produce other pocket containers in a variety of shapes depending on the preferences and applications, such as folding one or superposing two rectangular batter covers to form a square-shaped pocket container, and folding one diamond shaped or superposing two triangular batter covers to form an edible triangular pocket container, and so on. [0022] Having thus described preferred embodiments of the invention in sufficient detail to enable those skilled in the art to make and use the invention, it will nevertheless be appreciated that numerous variations and modifications of the illustrated embodiment may be made without departing from the spirit of the invention, and it is intended that the invention not be limited by the above description or accompanying drawings, but that it be defined solely in accordance with the appended claims.

1a

OBJECT OF THE INVENTION This invention refers to a game of entertainment, in particular to a game in which a plurality of movable pieces are incorporated, distributed according to an orthogonal reticle and susceptible to move on any of the axis of the level in which they are included. BACKGROUND OF THE INVENTION Entertainment games in which the type of pieces above mentioned are incorporated are well known. Flat pieces with a quadrangular outline, having two grooves on two of its edges and two nerves on the others, so that these nerves and grooves establish a tongue and groove joint among the pieces which allows the relative movement on the general level where they are included, as well as acting as a bond of union which does not allow its possible uncoupling. However, all these well known type of games are based in the establishment of a rectangular game surface, with a perimetric frame that closes it completely holding in majority the described moving pieces with the exception of an area equivalent to the dimensions of one of said pieces, so that this empty space allows the mobility of the same in order that, from an arbitrary or aleatory situation, a particular order is established among said pieces. This type of game, besides its own limitations as far as the possibility to develop game rules, can only be used by one player at a time. DESCRIPTION OF THE INVENTION The entertainment game that the invention proposes, although based on the aforementioned type of moving pieces differs substantially from any game already known and allows four players to participate, and establishes a true competition among them, but the number of players may also be three, two or even one. For this, in a more concrete way, the classic platform for the moving pieces materializes in a considerably thick body, which can be hollow, basically a prismatic-quadrangular shape, but with the peculiarity that its edges or lateral walls adopt a semicylindrical shape, having the moving pieces not only on the upper and square base of this body but also on its semicylindrical lateral walls and on its bottom base, so that said pieces form a plurality of annular line ups, in other words, closed on themselves, set up according to two perpendicular groups, so that on each line up the working on a particular piece assumes the movement of all the pieces that participate in said annular line up. As a complement of the described structure and in correspondence with each one of the sides of this prismatic body, a lateral deposit is established; therefore four lateral deposits exist corresponding to the four walls of the body and to the four players that participate in the game. The upper base of the prismatic body forms the true platform of the game and the lateral deposits are at a substantial lower level regarding said platform of the game, so that with the collaboration of several groups of chips, belonging to each player, which are placed conveninetly on the moving pieces of the upper platform, each player tends to move his/her chips towards his/her corresponding deposit, by moving the annular line ups of pieces that are perpendicular to his/her own deposit, into which said chips fall when they reach the ramp that defines the beginning of the semicylindrical sectors coresponding to the lateral walls or edges of the prismatic body. Inside these lateral deposits the chips can simply be stored or entered without any order or in addition if needed they can be placed orderly, for which in each of these lateral deposits there is also a pair of longitudinal and annular lines ups alike the initial body. For the working of the moving pieces each player will have a line up of push buttons in front os his/her deposit, that when pushed they act on the respective annular line ups of moving pieces, provoking them to advance a space equivalent to the length of one of said pieces. Each push button can act on the corresponding annular line up of pieces through the interstices existing between two adjacent ones. The button acts against a spring and in collaboration with a retractile trigger that cancels the motive effect of the push button during its recovery. Each deposit is provided with a lateral or end pulley wheel for the working of its own line up of moving pieces, being able to transversally move the pieces on the platform of the game that are on the parallel line up and near such deposit, while the rest, as mentioned before, can only be moved in perpendicular direction towards the deposit. For use in accordance with the game rules, caps have been provided to cover the four vertex, to stop the movement of these last transversal rows, so that the two end push buttons of each player are theoretically cancelled and therefore stop the other three players to intervene when the chips are on the last row and only allow, if the player wants or needs to, the player that is in front with his/her chips on the last row to intervene. Finally, the collaboration of an opaque panel with legs has been provided, that placed on the platform of the game hides it, with the exception of the last two rows of each player, in other words, legs would be placed on the four ends of the four caps mentioned earlier, without interfering in the movement of the pieces, so that when said panel is being used there is no visual control over the chips and it is necessary to memorize the own movements as well as the rest of the player's or just leave the results at random. DESCRIPTION OF THE DRAWINGS The following description of the preferred embodiment will be made with reference to the attached drawings, in which: FIG. 1. Gives a general view in perspective of the game of entertainment being the object of this invention. FIG. 2. Gives a detail in perspective, at a larger scale, of one of the moving pieces that participate in the game. FIG. 3. Gives a view in perspective of one of the caps that cancel the movement of the two end push buttons of each player with regards to the moving pieces of the vertex of the platform of the game. FIG. 4. It schematicly shows three of the possible embodiments of the lateral deposits for collection of the chips. FIG. 5. Shows a detail of the game, in cross section, at the level of the pulling mechanism of one of the annular line ups of moving pieces. FIG. 6. Shows a blow up in detail of FIG. 5. FIG. 7. Shows a detail in section at the level of one of the caps in FIG. 3. FIG. 8. Finally, this figure shows a transversal section alike FIG. 5, but at a level of any of the four marginal line ups of the moving pieces. PREFERRED EMBODIMENT OF THE INVENTION The game of entertainment is structured based on a body (1) with a prismatic-quadrangular shape, with its edges or lateral walls (2) curved semicylindrically, defining a quadrangular platform, over which a plurality of pieces (3) are placed, also quadrangular, of small size, provided on two of its edges with a groove (4) and on the other two with nerves (5) to form tongue and groove joints among them, making a relative movement possible. These pieces (3) form a plurality of adjacent line ups that close themselves in two perpendicular directions around the semicylindrical edges (2); to this purpose the height or thickness of the body (1) must be calculated to allow the pieces (3) to adapt to the semicylindrical edges and to keep the relationship among them, as shown in FIGS. 5 and 8. In these areas the inversion of these pieces is helped by outter walls (6), that hold them laterally, as also can be observed in said figures, and by another horizontal and lower wall (7), parallel and near the bottom base (1')of the body (1), which does not allow the fall of the pieces (3) by gravity in this area. The lateral and curved protection walls (6) extend to the outter part to form respective lateral deposits (8), one for each edge of the body; these lateral deposits (8) being a part of the outter cover (9) that completes the game not only laterally but also on the bottom. A plurality of push buttons (10) are set up in front of each lateral deposit (8), as many as annular line ups of pieces (3) lay perpendicular to said deposit (8). These push buttons, together with respective arms (12), act against the tension of respective springs (11), upon the corresponding annular line up pieces (3), causing it to advance towards the player a space equivalent to the length of one piece. A trigger (13) is joined (14) to the arm (12) and through its free end it is susceptible to be placed in the space (15) defined between two adjacent pieces (3), causing a push on the correspondent line up and an advance of same equivalence to the width of one of such pieces (3). The push button (10) recovers by the spring effect (11), and the trigger (13) scales against another little spring (16) slipping on the adjacent piece (3), as it has been represented in the discontinuous line on FIG. 6, until reaching the suitable position to push this piece as soon as push button (10) is pushed again. According to this structure, the game offers the possibility for four players to participate simultaneously, with a game platform on which, following the example of the preferred embodiment represented in the drawings, one hundred and fourty four operative reticles are set up, that means 12×12 pieces (3), on which different colour chips are conveniently set up for each player, except on the last row which means that one hundred chips are placed. The last row is left free for the freedom of movement. Each chip moves together with the movement of the piece (3) on which it is placed, until reaching one of the marginal areas of the platform, where said piece (3' in FIG. 5) takes a slanted arrangement that determines the fall by gravity of the chip placed over it, towards the correspondent lateral deposit (8). Each player will tend to move by means of the push buttons (10) his/her own chips towards his/her own deposit. The player will also be able to change, if convenient, the direction of the other players'chips, concious or unconciously. By choice, the marginal line ups of moving pieces (3), the ones shadowed in FIG. 1, can be blocked or immobilized in longitudinal direction, for which four blocking caps (17) have been provided, to fit on the upper part of a piece (3), as shown on FIG. 7; each one of these caps having on one of its vertex a lower arm (18) which can be introduced in a corresponding hole (19) provided in the game's cover (9). As said cap (17) is immobilized regarding the cover, it immobilizes as well the piece (3) situated in its cavity and this avoids the movements of the two annular line ups affected by said immobilized piece (3). The lateral deposits (8), used as chip colectors, may have different shapes, as it has been represented in FIG. 4. It can be a simple rectangle where the chips gather with no order; it can be mobile so that each of the chips to be gathered has a concrete position of each pair of chips has a concrete position. If it happens that the chips have a concrete position, in which case the blocking caps (17) will not be able to be used, each player can also move the transversal line up nearest to such deposit, besides being able to mobilize the line ups of pieces (3) running perpendicularly to the deposit. In order to move this transversal line up a polley wheel (20) has been provided, which acts through an adequate transmission (21) on a pinion (22), able to act in turn on the aforementioned transversal line up. As already said, the game allows two, three or four players to participate following a very large range of possible game rules, which are not the object of this invention. As mentioned earlier an opaque panel that will be fixed to the connection (19) on the cover (9) can also be used, in order to hide the platform, with the exception of each player's last row, which remains visible; this lack of visibility forces the players to memorize where the chips are placed, so increasing the difficulty. It is obvious that many alterations may be introduced in the board we have described without exceeding the scope of the claims. For example it may be operated electronically or by computer.

1a

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is a Section 371 filing of International Application No. PCT/DK2005/000285, filed 26 Apr. 2004, the disclosure of which is incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] The present invention relates to a skin-protecting alkalinity-controlling composition as well as the use of a composition comprising at least one carboxylic acid polysaccharide for skin protection and/or alkalinity control. [0003] Pectin is a complex polysaccharide associated with plant cell walls. It consists of an alpha 1-4 linked polygalacturonic acid backbone intervened by rhamnose residues and modified with neutral sugar side chains and non-sugar components such as acetyl, methyl, and ferulic acid groups. [0004] The neutral sugar side chains, which include arabinan and arabinogalactans, are attached to the rhamnose residues in the backbone. The rhamnose residues tend to cluster together on the backbone. So, with the side chains attached, this region is referred to as the hairy region and the rest of the backbone is hence named the smooth region. [0005] In U.S. Pat. No. 5,929,051, Ni, et al. pectin is described as a plant cell wall component. The cell wall is divided into three layers, middle lamella, primary, and secondary cell wall. The middle lamella is the richest in pectin. Pectins are produced and deposited during cell wall growth. Pectins are particularly abundant in soft plant tissues under conditions of fast growth and high moisture content. In cell walls, pectins are present in the form of a calcium complex. The involvement of calcium cross-linking is substantiated by the fact that chelating agents facilitate the release of pectin from cell walls as disclosed by Nanji (U.S. Pat. No. 1,634,879) and Maclay (U.S. Pat. No. 2,375,376). [0006] According to Dumitriu, S.: Polysaccharides, Structural diversity and functional versatility, Marcel Dekker, Inc., New York, 1998, 416-419, pectin is used in a range of food products. [0007] Historically, pectin has mainly been used as a gelling agent for jam or similar, fruit-containing, or fruit-flavoured, sugar-rich systems. Examples are traditional jams, jams with reduced sugar content, clear jellies, fruit-flavoured confectionery gels, non-fruit-flavoured confectionery gels, heat-reversible glazing for the bakery industry, heat-resistant jams for the bakery industry, ripples for use in ice cream, and fruit preparations for yoghurt. [0008] A substantial portion of pectin is used today for stabilization of low-pH milk drinks, including fermented drinks and mixtures of fruit juice and milk. [0009] The galacturonic acid residues in pectin are partly esterified and present as the methyl ester. The degree of esterification is defined as the percentage of carboxyl groups esterified. Pectin with a degree of esterification (“DE”) above 50% is named high methyl ester (“HM”) pectin or high ester pectin and one with a DE lower than 50% is referred to as low methyl ester (“LM”) pectin or low ester pectin. Most pectins found in plant material such as fruits, vegetables and eelgrass are HM pectins. [0010] Pectins are soluble in water and insoluble in most organic solvents. Pectins with a very low level of methyl-esterification and pectic acids are for practical purposes only soluble as the potassium or sodium salts. [0011] Pectins are most stable at pH 3-4. Below pH 3, methoxyl and acetyl groups and neutral sugar side chains are removed. At elevated temperatures, these reactions are accelerated and cleavage of glycosidic bonds in the galacturonan backbone occurs. Under neutral and alkaline conditions, methyl ester groups are saponified and the polygalacturonan backbone breaks through beta-elimination-cleavage of glycosidic bonds at the non-reducing ends of methoxylated galacturonic acid residues. These reactions also proceed faster with increasing temperature. Pectic acids and LM pectins are resistant to neutral and alkaline conditions since there are no or only limited numbers of methyl ester groups. [0012] Pectin is a weak acid, and is less soluble at low pH than at high pH. Thus, by changing the pH of the pectin during manufacture thereof a pectin having lower or higher solubility is provided. The pH is typically increased through the use of bases such as alkali metal hydroxides or alkali metal carbonates, but other bases are equally useable. For instance, by using sodium carbonate, sodium pectinate is formed and the higher the dosage of sodium carbonate and, thus, the higher the pH, the more of the carboxylic acids are transformed to their sodium salts. [0013] However, at higher pH the pectin starts to de-esterify during pH-adjustment, handling and storage. Thus the pH should be maintained at a level at or below pH 6. [0014] In some cases, pectin as manufactured is esterified in a block-wise fashion. WO 2004020472 describes this phenomenon as the block-wise de-esterification takes place in the raw material used for making pectin, and the disclosure relates to a method for eliminating this block-wise de-esterification. [0015] WO 8912648 discloses a method for transforming block-wise de-esterified pectin into pectin with a random distribution of ester groups. The method involves the use of polygalacturonase, which splits the pectin molecule in those areas of the pectin molecule that are non-esterified. Thus, this method provides a lower molecular weight pectin having a higher degree of esterification than the block-wise esterified starting pectin. [0016] According to Kertesz, Z. I: The Pectic Substances, Interscience Publishers, Inc, New York, 1951, pectic materials occur in all plant tissues. However, apples, beets, flax, grapefruit, lemons, limes, oranges, potatoes, and sunflower are of particular industrial importance. Lately, also the pectin in Aloe Vera has shown industrial utility. [0017] Pectin according to the present invention needs not be extracted from the pectin containing starting material. Such crude pectin preparations are disclosed in U.S. Pat. No. 2,132,065, U.S. Pat. No. 3,982,003, U.S. Pat. No. 4,831,127, WO 9115517, U.S. Pat. No. 5,354,851, U.S. Pat. No. 5,403,612, U.S. Pat. No. 5,567,462, U.S. Pat. No. 5,656,734, and WO 9749734. [0018] Other esterified carboxy acid polymers include, but are not limited to: Pectin ethyl ester, made using ethyl iodide and heating as disclosed by Kertesz, Z. I.: The Pectic Substances, Interscience Publishers, Inc., New York, 251, 1951. In addition, pectic acid and pectinic acid may be totally or partially esterified with aliphatic, arylaliphatic, cycloaliphatic or heterocyclic alcohols. When the acid is only partially esterified, the remaining free carboxyl groups may be salified with inorganic or organic bases. The esters may be used in the pharmaceutical, biomedical, alimentary and cosmetic fields. The esters may be prepared from a quaternary ammonium salt of pectic acid or pectinic acid and an esterifying agent such as a halogenide as disclosed in U.S. Pat. No. 5,384,400. Esterified polysaccharide manufactured with a ketene dimer using an enzyme as a catalyst under mild reaction conditions as disclosed in U.S. Pat. No. 6,624,298. The polysaccharide used is at least one selected from the group consisting of cellulose ethers, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethyl-cellulose, guar, cationic guar, and hydroxypropylguar. Starch esters. Methods for the preparation of starch esters are described in the article by Tessler, M. M. and Bilimers, R. L., Preparation of Starch Esters, in Journal of Environmental Polymer Degradation 4 (1996) 85-89 and further disclosed in U.S. Pat. No. 6,605,715. Polymerized sugar esters as described in U.S. Pat. No. 5,859,217. Esters of alginic acid. Examples include ethylene glycol and propylene glycol esters, methyl ester, homologues of methyl ester, and esters of aromatic, araliphatic, alicyclic and heterocyclic alcohols. Also included are esters deriving from substituted alcohols such as esters of bivalent aliphatic alcohols as disclosed in U.S. Pat. No. 5,416,205. [0024] According to www.smartskincare.com, sweat is a salty, watery solution produced by sweat glands, numerous microscopic channels opening onto the skin surface. As sebum and sweat mix up on the skin surface, they form a protective layer often referred to as the acid mantle. The skin is mildly acidic. In addition to helping protect skin from “the elements” (such as wind or pollutants), the acid mantle also inhibits the growth of harmful bacteria and fungi. If the acid mantle is disrupted or loses its acidity, the skin becomes more prone to damage and infection. The loss of acid mantle is one of the side effects of washing the skin with soaps or detergents of moderate or high strength. [0025] According to U.S. Pat. No. 5,837,254, fungal infections of the vagina or urinary tract are difficult to eradicate and frequently recur but are rarely life threatening. The normal pH of the genital tract is 4.5 to 5, which is maintained by lactobacillus . The absence of lactobacillus and a normal pH promotes candidiasis as well as the herpes virus, birth control pills, a weak immune system, genetic factors, stress and a host of other factors, which foster the growth of yeast and fungal infections of the genital tract. Candida albicans grows readily in a moist environment at a pH of more than 5. [0026] In U.S. Pat. No. 5,972,321 it is stated that although body odor may be partially due to certain chemicals secreted by sebaceous glands and eccrine sweat glands, major axillary (underarm) foul odor is due to secretions of the apocrine glands, which contain special nutrient materials for microorganisms. The apocrine glands secrete a milky fluid that has a pH range of 5 to 6.5 and initially consists of lipids, proteins and carbohydrates. Although gram-positive bacteria, which thrive on substances found on the moist skin surface, appear to be responsible for the production of malodor, the precise mechanisms of odor production are still unclear. [0027] According to U.S. Pat. No. 4,666,707, bath salt compositions are prepared by incorporating perfume, colorant, plant extract, organic acid and so on into an inorganic salt mixture comprising sodium sulfate, borax, sulfur, sodium chloride, carbonate salt, etc., and are used for the purpose of providing the bath with perfume and/or color, or adequately stimulating the skin to thereby promote the blood circulation, the recovery from fatigue and/or the metabolism. Among such bath salt compositions, there are foaming bath salt compositions comprising a combination of a carbonate salt and an acid, which produces, in the bath, carbon dioxide gas bubbles to thereby cause a relaxing or refreshing sensation and render bathing enjoyable. [0028] According to U.S. Pat. No. 6,589,923 and U.S. Pat. No. 4,335,025, upon washing with soap, a pH of 8-10 is established in the wash liquor. This alkalinity neutralizes the natural acid mantle of the skin (pH 5-6). Although in normal skin this acid mantle is reformed relatively quickly, in sensitive or pro-damaged skin irritations may result. A further disadvantage of soaps is the formation of insoluble lime soaps in hard water. Being alkaline, soap emulsifies the oily layer covering the natural horny layer (stratum corneum) of a person's skin and neutralizes a likewise natural acid mantle of the epidermis, which has, normally, an acid pH of approximately 5.5-6.5. Failure to readily regenerate the acid and oily part of the epidermis-particularly among older people-often results in dermatological symptoms, such as itching, chapping and cracking of the epidermis, especially in cold weather. Of course, always to be considered is that significant segment of the population, which is allergic to or cannot tolerate conventional soaps in view of a number of reactions (sensitivities) resulting from the use thereof. [0029] According to U.S. Pat. No. 6,551,987, U.S. Pat. No. 6,013,618 and U.S. Pat. No. 5,626,852, pro-fragrances are compounds, which under certain conditions break down to fragrances. For instance, tris(9-decenyl) when exposed to suitable conditions (e.g., exposure to the acid mantle of human skin) breaks down to release a mixture of 9-decenol and 9-decenyl formate, both of which are fragrance raw materials. [0030] In U.S. Pat. No. 6,352,700 it is stated that while products exist that are said to address the problems of skin irritation and inflammation, they inevitably fail to address the short-term impact of various additives on the pH balance of the skin, i.e., the skin's acid mantle. To put this into perspective, one need only to consider conventional facial tissue, toilet tissue, napkin and paper towel products that are used for wiping dry or wet skin. Upon contact with skin, the tissue products transfer some of the chemicals present in the tissue to the skin surface. [0031] According to U.S. Pat. No. 6,150,405 and U.S. Pat. No. 5,667,769, some hair care preparations particularly for treating hair loss, contain hydroxyl scavengers. [0032] According to U.S. Pat. No. 4,761,279, the application of a conventional shaving preparation of high alkalinity is often irritating to the skin. [0033] U.S. Pat. No. 2,253,389 discloses the use of alkali to make pectin, which does not require sugar and acid to form gels. A gel is formed by soluble pectin in a neutral or slightly alkaline aqueous medium in the presence of a metal compound, and it is stressed that the alkalinity must be insufficient to convert pectin to pectate. The resulting gelling agent is particularly useful for substituting gelatine in jellies of water and milk. [0034] GB 541,528 discloses the importance of applying low temperature for demethoxylating pectin. By controlling alkali hydrolysis of pectin at temperatures between 10° C. and the freezing point of the pectin solution, low ester pectin of high setting power and with a low setting temperature can be made. Hydrolysis is performed in an aqueous medium and the hydrolysis is terminated by neutralization. It is disclosed that the hydrolysis is very rapid at pH 12 and very slow at pH 8.5. [0035] U.S. Pat. No. 2,478,170 discloses pectin with 20-30% remaining acid groups, which gel by the addition of calcium ions, with or without sugar. Alkalis are alkali metal hydroxides, ammonium hydroxide, sodium carbonate, organic ammonium bases etc. and the process involves an aqueous solution or extract of pectin being adjusted to temperatures below 35° C. and pH 10-12. When the desired methoxyl content is reached, pH is reduced to 4, and the pectinic acid is isolated. [0036] In “The Pectic Substances”, Interscience Publishers, Inc., New York, 1951, Kertesz describes the effect of bases on pectin. When alkali is added to a pectin solution to an extent, which is higher than the amount needed for neutralizing the pectin, demethoxylation commences. This process consumes the alkali and the pH of the solution soon drops. Kertesz also refers to other findings, which suggest that the consumption of alkali increases as a result of the alkali concentration, or the duration of treatment with alkali, or as the temperature of the reaction is raised. Thus, he suggests that this alkali consumption may be utilized for determining the ester content of pectinic acids. [0037] JP 2001226220 discloses the use of alcohol extracted Citrus junos seed pectin to make a skin lotion composed of said pectin, deep sea layer water and sea water or water. The lotion is characterized by being non-sticky, non-irritant and by having a low pH. Conventionally, pectin is extracted in water, whereas alcohol is known to make pectin insoluble. In addition, the disclosure does not discuss the composition of the pectin. [0038] WO 02/14374 discloses the use of hydrocolloids as thickening or emulsifying agents for a variety of products, such as foodstuffs, pharmaceutical compositions, personal care products and beverages. [0039] WO 04/005352 discloses the use of amidated pectins, such as in crimes, lotions and household products. [0040] U.S. Pat. No. 6,509,311 discloses a gel system comprising propylene glycol alginate as a gelling agent, as a water binder, as an emulsifier and as a stabiliser. [0041] A need for a composition remains, which is capable of providing buffering, thus avoiding a major increase in the pH of an aqueous system and/or useable for reducing the pH of aqueous systems, in which alkalinity is formed as a result of chemical and/or biological reactions, or as a result of alkalinity being imposed on the aqueous system by the environment. In particular, there is a need for a composition, which will protect the acid mantle, and there is a need for incorporating such a composition in articles, which are in contact with the skin, either human skin or animal skin. BRIEF SUMMARY OF THE INVENTION [0042] The present invention thus relates to a skin-protecting alkalinity-controlling composition comprising one or more carboxylic acid polysaccharides wherein at least one of said carboxylic acid polysaccharide(s) is a high DE carboxylic acid polysaccharide having a degree of esterification (DE) in the range from about 70% to about 100%, more preferably from about 80% to about 100%. [0043] The present invention furthermore relates to a skin-protecting alkalinity-controlling composition comprising a mixture of at least one high DE carboxylic acid polysaccharide having a degree of esterification (DE) in the range from about 70% to about 100%, more preferably from about 80% to about 100%, and at least one low DE carboxylic acid polysaccharide having a degree of esterification (DE) in the range from about 5 to about 70%, more preferably from about 5% to about 40%, and most preferably from about 10% to about 35%. [0044] The present invention furthermore relates to the use of at least one carboxylic acid polysaccharide for skin protection and/or alkalinity control. [0045] The invention is disclosed in more detail in the following by means of the accompanying drawings and exemplary embodiments of preferred embodiments of the invention. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0046] The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings: [0047] FIG. 1.1 shows the alkali consumption of pectins of different molecular weight, [0048] FIG. 1.2 shows the pH-drop over time for the above pectins by dissolution at 70° C., [0049] FIG. 1.3 shows the pH-drop over time for the above pectins by dissolution at 20° C., [0050] FIG. 2.1 shows the alkali consumption of pectins of different degrees of esterification (DE), [0051] FIG. 2.2 shows the pH-drop of the above pectins by dissolution at 70° C., [0052] FIG. 2.3 shows the pH-drop of the above pectins by dissolution at 20° C., [0053] FIG. 2.4 shows the initial about 130 minutes pH-drop of the above pectins dissolved either at 70° or at 20° C., [0054] FIG. 3.1 shows the alkali consumption of either a block-wise or randomly esterified pectin of similar DE, [0055] FIG. 3.2 shows the pH-drop of the above pectins dissolved at either 70° or 20° C., [0056] FIG. 3.3 shows the initial about 100 minutes pH-drop of the above pectins, [0057] FIG. 4.1 shows the pH-drop of a pectin held at various temperatures, [0058] FIG. 5.1 shows the effect of multiple alkali dosages to a pectin, [0059] FIG. 6.1 shows the effect of pectin concentration on pH-drop, [0060] FIG. 7.1 shows the pH-drop of ion-exchanged water without addition of pectin or other additions, [0061] FIG. 8.1 shows the alkali consumption of propylene glycol alginates (PGA) of different degrees of esterification, [0062] FIG. 8.2 shows the pH-drop of the above PGAs by dissolution at 70° C., [0063] FIG. 8.3 shows the pH-drop of the above PGAs by dissolution at 20° C., [0064] FIG. 8.4 shows the initial about 70 minutes pH-drop of the above PGAs by dissolution at either 70° or 20° C., [0065] FIG. 9.1 shows the effect of multiple alkali dosages to propylene glycol alginate, [0066] FIG. 10.1 shows the pH-drop of lotions containing pectin in either the water phase or the oil phase, [0067] FIG. 11.1 shows the pH-drop of cloth soaked in a solution of 0.01% pectin of different molecular weights, [0068] FIG. 11.2 shows the pH-drop of cloth soaked in a solution of 0.05% pectin of different molecular weights, [0069] FIG. 11.3 shows the pH-drop of cloth soaked in a solution of 0.10% pectin of different molecular weights, [0070] FIG. 11.4 shows the pH-drop of cloth soaked in a solution of 0.20% pectin of different molecular weights, and [0071] FIG. 11.5 shows the pH-drop of cloth soaked in a solution of 0.50% pectin of different molecular weights. [0072] FIG. 12.1 shows the alkali consumption of a mixture of 50% of a pectin having a DE of 93.4% and 50% of a pectin having a DE of 9.6% dissolved at 70° C. and compared with the alkali consumption of the individual components. [0073] FIG. 12.2 shows the pH-drop over time of the above mixture dissolved at 70° C. and compared with the pH-drop of the individual components. [0074] FIG. 13.1 shows the alkali consumption of a mixture of 50% of a pectin having a DE of 93.4% and 50% of a propylene glycol alginate (PGA) having a DE of 55% dissolved at 70° C. and compared with the alkali consumption of the individual components. [0075] FIG. 13.2 shows the pH-drop over time of the above mixture dissolved at 70° C. and compared with the pH-drop of the individual components. [0076] FIG. 14.1 shows the alkali consumption of a mixture of 50% of a propylene glycol alginate (PGA) having a DE of 85% and 50% of a pectin having a DE of 9.6% dissolved at 70° C. and compared with the alkali consumption of the individual components. [0077] FIG. 14.2 shows the pH-drop over time of the above mixture dissolved at 70° C. and compared with the pH-drop of the individual components. DETAILED DESCRIPTION OF THE INVENTION [0078] The skin-protecting alkalinity-controlling composition according to the invention comprises one or more high DE carboxylic acid polysaccharides selected from the group comprising pectin esters, esterified cellulose ethers, esterified hydroxyethylcellulose, esterified carboxymethylcellulose, esterified guar gum, esterified cationic guar gum, esterified hydroxypropyl guar gum, starch esters, and polymerized sugar esters. [0079] A high DE carboxylic acid polysaccharide provides for a rapid pH-drop due to the low amount of free carboxylic acid groups present. Thus, if a rapid pH-drop is needed, a high DE carboxylic acid polysaccharide should be used. This fact can be utilized in a range of products intended to be applied to the skin of humans or animals. Uses include but are not limited to lotions, creams, foundations, face masks, hair care products, genital lotions, deodorants, ostomy products, feminine hygiene products, laundry products, bath salt products, soap products, fragrance products, lotionized tissue products, and shaving products. Further, such pectin can be used in similar products to treat animals. [0080] In a preferred embodiment according to the invention, said high DE carboxylic acid polysaccharide is a pectin ester, preferably a pectin ester of aliphatic, arylaliphatic, cycloaliphatic or heterocyclic alcohols, more preferably an ester of methanol, ethanol, propanol or isopropanol, and most preferably an ester of methanol. [0081] The advantage of using methanol esters of pectin is the natural occurrence of such ester. However, without being bound by theory, methyl esters of pectin are more prone to liberate the alcohol part thereof during de-esterification. Esters of pectin with higher alcohols are not as prone to alkaline de-esterification. [0082] In a still more preferred embodiment of the invention, said pectin is of a molecular weight in the range from about 5,000 to about 140,000, preferably in the range from about 10,000 to about 125,000, most preferably in the range from about 10,000 to about 40,000. As demonstrated in example I below, the molecular weight of pectin has no influence on the alkali consumption or on the pH drop encountered. However, by adjusting the molecular weight of the pectin it is possible to adjust the amount of pectin, which may be dissolved or suspended in a final product. Thus, as disclosed in more detail in example 11, a lower molecular weight pectin is easier to dissolve and the viscosity of the resulting pectin-containing solution is lower than in a corresponding higher molecular weight-containing pectin. This fact can be utilized to obtain a relatively highly concentrated pectin-solution having suitably low viscosity, e.g. for use in fabric-treating products. The pectin having a molecular weight below about 40,000 can be made at concentrations above about 10% without causing unacceptable high viscosity. Such pectin could be manufactured and marketed as a concentrated solution with a pectin concentration in excess of 10%. Alternatively, the possibility of making such pectin solution in concentrations above about 10% makes spray-drying of such solutions economically feasible. [0083] The degree of esterification indicates the average DE of any given polysaccharide. By controlling the distribution of ester groups along the polysaccharide chain to obtain either a random or a block-wise distribution of ester groups, it is possible to obtain a locally higher or lower DE polysaccharide. As demonstrated in example 3, the alkali consumption of a pectin having a block-wise ester group distribution is the same as the alkali consumption of a corresponding pectin having a random ester group distribution. However, the pH-drop of the two pectins is considerably larger for the block-wise esterified pectin, presumably because such pectin will act as a pectin with a higher average DE. Thus, by treating a block-wise esterified pectin with a polygalacturarase, which splits the pectin at non-esterified sites, a lower molecular weight pectin may be obtained having an increased DE. [0084] In an alternative embodiment of the composition according to the invention, the ester groups of the polysaccharide thereof are thus distributed in a block-wise fashion. [0085] In another embodiment of the composition according to the invention, the ester groups of the polysaccharide are distributed in a random fashion. [0086] In another preferred embodiment according to the invention, the skin-protecting alkalinity controlling composition comprises a mixture of at least one high DE-carboxylic acid polysaccharide having a degree of esterification (DE) in the range from about 70% to about 100%, more preferably from about 80% to about 100%, and at least one low DE-carboxylic acid polysaccharide having a degree of esterification (DE) in the range from about 5 to about 70%, more preferably from about 5 to about 40%, most preferably from 10 to about 35%. [0087] A carboxylic acid polysaccharide having a relatively low DE provides for a large alkali consumption capacity or buffer capacity. [0088] An advantage of a higher buffer capacity is the ability of the pectin to neutralize an initial high concentration of alkali. This is an advantage particularly when fabrics are insufficiently depleted for alkaline washing powder. Thus, by combining a low DE and a high DE carboxylic acid polysaccharide, an initial alkali consumption buffering can be obtained succeeded by a pH-reduction. [0089] In a preferred embodiment according to the invention, any of said high DE carboxylic acid polysaccharides and said low DE carboxylic acid polysaccharides is selected from the group comprising pectin esters, alginic acid esters, esterified cellulose ethers, esterified hydroxyethylcellulose, esterified carboxymethylcellulose, esterified guar gum, esterified cationic guar gum, esterified hydrocypropyl guar gum, starch esters, and polymerized sugar esters. [0090] In a particular embodiment according to the invention, any of said high DE carboxylic acid polysaccharides and said low DE carboxylic acid polysaccharides is a pectin ester, preferably a pectin ester of aliphatic, arylaliphatic, cycloaliphatic or heterocyclic alcohols, more preferably an ester of methanol, ethanol, propanol or isopropanol, and most preferably an ester of methanol. [0091] In a more particular embodiment according to the invention, any of said high DE carboxylic acid polysaccharides and said low DE carboxylic acid polysaccharides is a pectin having a molecular weight in the range from about 5,000 to about 140,000, preferably in the range from about 10,000 to about 125,000, most preferably in the range from about 10,000 to about 40,000. [0092] In an alternative embodiment according to the invention, any of said high DE carboxylic acid polysaccharides and said low DE carboxylic acid polysaccharides is an esterified alginic acid. [0093] In a preferred embodiment of the invention, any of said esterified alginic acids is an alginic acid ester of aliphatic, aromatic, araliphatic, alicyclic and heterocyclic alcohols, including esters deriving from substituted alcohols such as esters of bivalent aliphatic alcohols, preferably ethylene glycol or propylene glycol alginate. U.S. Pat. No. 5,416,205 discloses suitable alginic acid derivatives, and the reference is enclosed herewith in its entirety. [0094] In a further embodiment according to the invention, the ester groups of any of said high DE carboxylic acid polysaccharides and said low DE polysaccharides are distributed in a block-wise fashion. [0095] In another embodiment according to the invention, the ester groups of any of said high DE carboxylic acid polysaccharides and said low DE polysaccharides are distributed in a random fashion. [0096] In another embodiment of the invention, a composition comprising at least one carboxylic acid polysaccharide selected from the group comprising pectin esters, alginic acid esters, esterified cellulose ethers, esterified hydroxyethylcellulose, esterified carboxymethyl-cellulose, esterified guar gum, esterified cationic guar gum, esterified hydropropyl guar gum, starch esters, and polymerized sugar esters is used for skin protection and/or alkalinity control. [0097] In a preferred embodiment according to the invention, said carboxylic acid polysaccharide is a pectin ester, preferably a pectin ester of aliphatic, arylaliphatic, cycloaliphatic or heterocyclic alcohols, more preferably an ester of methanol, ethanol, propanol or isopropanol, and most preferably an ester of methanol. [0098] In another embodiment according to the invention, said carboxylic acid polysaccharide is a pectin having a molecular weight in the range from about 5,000 to about 140,000, preferably in the range from about 10,000 to about 125,000, most preferably in the range from about 10,000 to about 40,000. [0099] In another embodiment according to the invention, said carboxylic acid polysaccharide is an esterified alginic acid. [0100] In another embodiment according to the invention, said esterified alginic acid is selected from the group comprising alginic acid esters of aliphatic, aromatic, araliphatic, alicyclic and heterocyclic alcohols, including esters deriving from substituted alcohols such as esters of bivalent aliphatic alcohols, preferably ethylene glycol alginate or propylene glycol alginate. [0101] In another embodiment according to the invention, the ester groups of said polysaccharide are distributed in a block-wise fashion. [0102] In another embodiment according to the invention, the ester groups of said polysaccharide are distributed in a random fashion. [0103] In another embodiment of the use according to the invention, at least one of said carboxylic acid polysaccharide(s) is a high DE carboxylic acid polysaccharide having a degree of esterification (DE) in the range from about 70% to about 100%, more preferably from about 80% to about 100%. [0104] In another embodiment of the use according to the invention, at least one of said carboxylic acid polysaccharide(s) is a low DE carboxylic acid polysaccharide having a degree of esterification (DE) in the range from about 5 to about 70%, more preferably from about 5% to about 40%, and most preferably from about 10% to about 35%. [0105] In another embodiment according to the invention of the use of a composition, said composition comprises a mixture of at least one of carboxylic acid polysaccharide having a degree of esterification (DE) in the range from about 70% to about 100%, more preferably from about 80% to about 100%; and at least one carboxylic acid polysaccharide having a degree of esterification (DE) in the range from about 5 to about 70%, more preferably from about 5% to about 40%, and most preferably from about 10% to about 35%. [0106] The composition according to the invention is suitable for use in personal care products. [0107] In a preferred embodiment, said products are for use on human skin. [0108] In another embodiment, said products are for use on animal skin. [0109] In a particular embodiment according to the invention, the skin protecting alkalinity-controlling composition is used in a product selected from the group consisting of skin creams, skin lotions, deodorant products, fragrance products, hair care products, shaving products, soap products, and bath salt products. [0110] In another embodiment according to the invention, the skin protecting alkalinity-controlling composition is used in a product selected from the group consisting of female hygiene products and diapers. [0111] A particular advantage of the present composition is the fact that they are capable of controlling the alkalinity of the surface, to which they are applied, for a prolonged time. As demonstrated in examples 5 and 8, the carboxylic acid polysaccharides are capable of controlling the alkalinity at multiple challenges of alkalinity. This fact can be utilized in e.g. deodorant products, diapers or female hygiene products, which are repeatedly exposed to sweat that is decomposed by micro-organisms to alkaline substances. Thus, a prolonged effective alkalinity control may be obtained by the products according to the present invention. [0112] In another embodiment according to the invention, the skin-protecting alkalinity-controlling composition is used in a product selected from the group consisting of ostomy products and wound care products. [0113] In ostomy products a low solubility polysaccharide, such as a low solubility pectin, should be used, since the ostomy product should remain insoluble for a longer period of time during flushing by body fluids. In this particular case a combination of a low DE and a low pH pectin would provide for a longer durability of the ostomy product during use. [0114] In a particular embodiment such low solubility low DE pectin should be combined with a higher solubility pectin having a higher DE to maintain a skin pH closer to the optimum skin pH of 5.5. [0115] In still another embodiment according to the invention, the skin-protecting alkalinity-controlling composition is used in a product selected from the group consisting of lotionized tissue products, fabric treating products, and laundry rinse products. [0116] Extraction of Pectin [0117] Pectin is extracted using the following steps. The degree of esterification was controlled in the range of about 76% to about 30% through shorter or longer extraction times. The process is as follows: 1. 15 litres of water was heated to 70° C. in a stainless steel, jacketed vessel having a volume of 18 litres and equipped with a stirrer. 2. 500 g dried citrus peel or dried beet cossets was added to the water, and the pH is adjusted to 1.7-1.8 by addition of 62% nitric acid. 3. Extraction was carried out at 70° C. for 2-24 hours depending on the desired degree of esterification while stirring. 4. After extraction, the content of the vessel was filtered on a Bücher funnel using diatomaceous earth as filter aid. 5. The filtered extract was ion exchanged while stirring by adding 50 ml resin (Amberlite SRIL, produced by Rohm&Haas) per litre of filtered extract. While stirring, the ion exchange was carried out during 20 minutes while stirring. 6. The ion exchanged filtrate was filtered on a Bücher funnel equipped with a cloth. 7. The filtered ion exchanged filtrate was precipitated by adding it to three parts of 80% isopropanol while stirring gently. 8. The precipitate was collected on nylon cloth and pressed by hand to remove as much isopropanol as possible. 9. The hand pressed precipitate was washed once in 60% isopropanol and then dried at 70° C. in a drying cabinet at atmospheric pressure. 10. After drying, the pectin was milled. [0128] Preparation of Pectin with Degree of Esterification Below 30% 1. The pressed precipitate made according to the procedure under a) point 8 was suspended in 60% isopropyl alcohol at 5° C. 2. Concentrated NaOH solution was added and the slurry was stirred for about one hour. The amount of NaOH is calculated to produce the desired DE. 3. The pectin solid was separated on nylon cloth, and washed twice in 60% isopropyl alcohol at pH 4. 4. The pectin solid was separated on nylon cloth, dried at 70° C. and milled. [0133] Preparation of Pectin with Different Molecular Weight 1. Pectin extracted according to a) was dissolved in about 80° C. ion exchanged water to form a 5% solution. 2. After cooling the solution to about 25° C., pH was adjusted to 5.50 with NH 3 . 3. Samples of the cold solution were treated with pectin lyase in concentrations ranging from 0 to 1300 micro litres per 10 litres of pectin solution. 4. Each sample was treated with its enzyme preparation for 1 hour at 25° C. while stirring. 5. After treatment, the pH was adjusted to 2.50 and the samples were heated at 80° C. for 10 minutes to inactivate the enzyme. 6. The samples were lastly precipitated in isopropyl alcohol, washed in isopropyl alcohol, dried and milled. [0141] Preparation of Pectin with Degree of Esterification Above 80% 1. 50 g. pectin as prepared under a) was added 2.5 g. dimethylaminopyridine, 100 ml. methanol and 100 ml. heptane in suitable flask and the mixture was cooled to minus 4° C. 2. 15 ml thionylchloride was over a period of 10 minutes added as drops to the mixture. 3. Over about 24 hours, the mixture was allowed to heat to about 21° C. 4. The solid was filtered, washed twice with first 60% isopropyl alcohol and secondly with 100% isopropyl alcohol. 5. The solid was dried at about 70° C. [0147] Preparation of Pectin with Different Distribution of Ester Groups 1. Pectin extracted according to a) was dissolved in about 80° C. ion exchanged water to form a 2% solution. 2. The solution was cooled to 45° C. and pH was adjusted to 4.5 with NH 3 . 3. Samples were added 2-4% of enzyme preparation while stirring: Plant esterase (Collopulin) for a block wise do-esterification and bacterial esterase (Rheozyme) for random de-esterification. 4. The degree of esterification was monitored through titration with 2% NH 3 at constant pH of 4.5. 5. After de-esterification, decreasing the pH to 2.5 with HNO 3 and subsequently heating the sample to 80° C. for 10 minutes inactivated the enzyme. 6. The sample was precipitated in isopropyl alcohol, washed in isopropyl alcohol, dried and milled. [0154] Determination of Molecular Weight (Mw) and Intrinsic Viscosity (V) [0155] For this, High Performance Size Exclusion Chromatography (HPSEC) with triple detection is used. [0156] Principle [0157] A pectin sample is fractionated according to hydrodynamic volume, using size exclusion chromatography. After separation, the sample is analysed by a triple detector system, consisting of a refractive index (RI) detector, a Right Angle Laser Light Scattering (RALLS) detector and a differential viscometer. Information from these detectors leads to determination of molecular weight (Mw) and intrinsic viscosity (IV). The Mark-Houwink factor is calculated using the molecular weight and intrinsic viscosity as obtained using this method. [0158] Materials: 1. Pump model 515, Waters, Hedehusene, Denmark. 2. Degasser, Gynkotek, Polygen Scandinavia, Århus, Denmark. 3. Column oven, Waters, Hedehusene, Denmark. 4. AS-3500 Auto sampler, with sample preparation module, Dionex Denmark, Rødovre, Denmark. 5. 3 linear mixed bed columns, TSK-GMPWXL, Supelco, Bellefonte Pa., USA. 6. Liquid phase: 0.3 M lithium acetate buffer pH 4.8, Fluka Chemie A G, Buchs, Switzerland. 7. Dual detector, RI, Viscometry, Model 250, Viscotek, Houston, Tex., USA. 8. RALLS Model 600, Viscotek, Houston, Tex., USA. [0167] Method: [0168] Approximately 2 mg of the sample is weighed into a 2000 μl vial. The sample is then dissolved in the auto sampler, by following schedule: 8 μl of ethanol is added, then 1300 μl of acetate buffer (0.3 M, pH 4.8), sample is heated to 75° C. and mixed for 9.9 minutes. 300 μl of the preparation is diluted with 900 μl of acetate buffer, then mixing for 9.9 minutes. Sample is left at ambient temperature for 20 minutes. 100 μl of the sample is injected with a 100 μl full loop and flow rate is 0.8 ml/min. Two detectors are present in line, a right angle laser light Scattering (RALLS) detector (Viscotek) and a dual detector consisting of a refractive index detector and a viscometer (Viscotek). [0169] The specific refractive index increment (dn/dc) value for pectin is set at 0.144. Data from detectors are processed by tri-SEC software (Viscotek). [0170] Determination of Degree of Esterification (DE) and Galacturonic Acid (GA) in Non-Amide Pectin [0171] Principle [0172] This method pertains to the determination of % DE and % GA in pectin, which does not contain amide and acetate ester. [0173] Apparatus: 1. Analytical balance 2. Glass beaker, 250 ml, 5 pieces 3. Measuring glass, 100 ml 4. Vacuum pump 5. Suction flask 6. Glass filter crucible no. 1 (Büchner funnel and filter paper) 7. Stop watch 8. Test tube 9. Drying cabinet at 105° C. 10. Dessicator 11. Magnetic stirrer and magnets 12. Burette (10 ml, accuracy±0.05 ml) 13. Pipettes (20 ml: 2 pieces, 10 ml: 1 piece) 14. pH-meter/autoburette or phenolphtalein [0188] Chemicals: 1. Carbon dioxide-free water (deionized water) 2. Isopropanol (IPA), 60% and 100% 3. Hydrochloride (HCl), 0.5 N and fuming 37% 4. Sodium hydroxide (NaOH), 0.1 N (corrected to four decimals, e.g. 0.1002), 0.5 N 5. Silver nitrate (AgNO 3 ), 0.1 N 6. Nitric acid (HNO 3 ), 3 N 7. Indicator, phenolphtalein, 0.1% [0197] Procedure—Determination of % DE and % GA (Acid alcohol: 100 ml 60% IPA+5 ml HCl fuming 37%): 1. Weigh 2.0000 g pectin in a 250 ml glass beaker. 2. Add 100 ml acid alcohol and stir on a magnetic stirrer for 10 min. 3. Filtrate through a dried, weighed glass filter crucible. 4. Rinse the beaker completely with 6×15 ml acid alcohol. 5. Wash with 60% IPA until the filtrate is chloride-free (approximately 500 ml). 6. Wash with 20 ml 100% IPA. 7. Dry the sample for 2½ hours at 105° C. 8. Weigh the crucible after drying and cooling in desiccator. 9. Weigh accurately 0.4000 g of the sample in a 250 ml glass beaker. 10. Weigh two samples for double determination. Deviation between double determinations must max. be 1.5% absolute. If deviation exceeds 1.5% the test must be repeated. 11. Wet the pectin with approx. 2 ml 100% IPA and add approx. 100 ml carbon di-oxide-free, deionized water while stirring on a magnetic stirrer. [0209] (Chloride test on ash-free and moisture-free basis: Transfer approximately 10 ml filtrate to a test tube, add approximately 3 ml 3 N HNO 3 , and add a few drops of AgNO 3 . The filtrate will be chloride-free if the solution is clear, otherwise there will be a precipitation of silver chloride.) [0210] The sample is now ready for titration, either by means of an indicator or by using a pH-meter/autoburette. [0211] Procedure—Determination of % DE only (Acid alcohol: 100 ml 60% IPA+5 ml HCl fuming 37%): 1. Weigh 2.00 g pectin in a 250 ml glass beaker. 2. Add 100 ml acid alcohol and stir on a magnetic stirrer for 10 minutes. 3. Filtrate through a Büchner funnel with filter paper. 4. Rinse the beaker with 90 ml acid alcohol. 5. Wash with 1000 ml 60% IPA. 6. Wash with approximately 30 ml 100% IPA. 7. Dry the sample for approximately 15 minutes on Büchner funnel with vacuum suction. 8. Weigh approximately 0.40 g of the sample in a 250 ml glass beaker. 9. Weigh two samples for double determination. Deviation between double determinations must max. be 1.5% absolute. If deviation exceeds 1.5% the test must be repeated. 10. Wet the pectin with approximately 2 ml 100% IPA and add approx. 100 ml de-ionized water while stirring on a magnetic stirrer. [0222] The sample is now ready for titration, either by means of an indicator or by using a pH-meter/autoburette. Note: It is very important that samples with % DE<10% are titrated very slowly, as the sample will only dissolve slowly during titration. [0223] Titration using indicator: 1. Add 5 drops of phenolphtalein indicator and titrate with 0.1 N NaOH until change of color (record it as V 1 titer). 2. Add 20.00 ml 0.5 N NaOH while stirring. Let stand for exactly 15 min. When standing the sample must be covered with foil. 3. Add 20.00 ml 0.5 N HCl while stirring and stir until the color disappears. 4. Add 3 drops of phenolphtalein and titrate with 0.1 N NaOH until change of color (record it as V 2 titer). [0228] Blind test (Double determination is carried out): 1. Add 5 drops phenolphtalein to 100 ml carbon dioxide-free or dionized water (same type as used for the sample), and titrate in a 250 ml glass beaker with 0.1 N NaOH until change of color (1-2 drops). 2. Add 20.00 ml 0.5 N NaOH and let the sample stand untouched for exactly 15 minutes. When standing the sample must be covered with foil. 3. Add 20.00 ml 0.5 N HCl and 3 drops phenolphtalein, and titrate until change of color with 0.1 N NaOH (record it as B 1 ). Maximum amount allowed for titration is 1 ml 0.1 N NaOH. If titrating with more than 1 ml, 0.5 N HCl must be diluted with a small amount of deionized water. If the sample has shown change of color on addition of 0.5 N HCl, 0.5 N NaOH must be diluted with a small amount of carbon dioxide-free water. Maximum allowed dilution with water is such that the solutions are between 0.52 and 0.48 N. [0232] Titration using pH-meter/Autoburette: [0233] Using Autoburette type ABU 80 the following settings may be applied: [0000] Sample with % DE < 10 Blind test Proportional band 0.5 5 Delay sec. 50 5 Speed - V1 10 5 Speed - V2 15 5 1. Titrate with 0.1 N NaOH to pH 8.5 (record the result as V 1 titer). 2. Add 20.00 ml 0.5 N NaOH while stirring, and let the sample stand without stir-ring for exactly 15 minutes. When standing the sample must be covered with foil. 3. Add 20.00 ml 0.5 N HCl while stirring and stir until pH is constant. 4. Subsequently, titrate with 0.1 N NaOH to pH 8.5 (record the result as V 2 titer). [0238] Blind test (Double determination is carried out): 1. Titrate 100 ml carbon dioxide-free or deionized (same type as used for the sample) water to pH 8.5 with 0.1 N NaOH (1-2 drops). 2. Add 20.00 ml 0.5 N NaOH while stirring and let the blind test sample stand without stirring for exactly 15 min. When standing the sample must be covered with foil. 3. Add 20.00 ml 0.5 N HCl while stirring, and stir until pH is constant. 4. Titrate to pH 8.5 with 0.1 N NaOH (record it as B 1 ). Maximum amount allowed for titration is 1 ml 0.1 N NaOH. If titrating with more than 1 ml, 0.5 N HCl must be diluted with a small amount of deionized water. If pH does not fall to below 8.5 on addition of 0.5 N HCl, 0.5 N NaOH must be diluted with a small amount of carbon dioxide-free water. Maximum allowed dilution with water is such that the dilutions are between 0.52 and 0.48 N. [0243] Calculation: [0000] V t =V 1 +( V 2 −B 1 ) [0000] % DE (Degree of Esterification)={( V 2 −B 1 )×100 }/V t [0000] % DFA (Degree of Free Acid)=100−% DE [0000] % GA*(Degree of Galacturonic acid)=(194.1× V t ×N× 100)/400 (194.1: Molecular weight for GA N: Corrected normality for 0.1 N NaOH used for titration (e.g. 0.1002 N) 400: weight in mg of washed and dried sample for titration) [0000] % Pure pectin={(acid washed,dried amount of pectin)×100}/(weighed amount of pectin) [0247] Determination of pH-Drop 1. 1 g. pectin was dissolved in 100 g. deionized water at 70° C. and at 20° C. 2. The solution was placed in a thermostatically controlled water bath and continuously stirred. 3. 0.1 M NaOH was added to a pH of between 9 and 10. 4. The pH was recorded as a function of time [0252] Determination of Titration Curves 1. 2 g. pectin was dissolved in 200 g. deionized water at 70° C. and at 20° C. 2. The solution was placed in a thermostatically controlled water bath at 25° C. and continuously stirred. 3. 0.1 M NaOH was added to the solution and pH recorded as a function of added 0.1 M NaOH. [0256] Propylene glycol alginate—Quantitative determination of the ester groups is carried out by the saponification method described on pages 169-172 of “Quantitative organic analysis via functional groups”, 4th Edition, John Wiley and Sons Publication. 1. Kelcoloid O manufactured by ISP Technologies, Inc. Esterification: High—about 85%. 2. Manucol Ester ER/K manufactured by ISP Technologies, Inc. Esterification: High—about 80%. 3. Kelcoloid HVF manufactured by ISP Technologies, Inc. Esterification: Medium—about 55% [0260] Preparation of Lotion and pH-Drop in Lotion [0261] Lotions were prepared according to the composition: [0000] TABLE 2.1.1 Composition of Lotion Ingredient grams % Comment Isopropyl 59 18.11 Waglinol 6016; manufactured by Palmitate Industrail Quimica Lasem SA; Spain Emulsifier 20 6.14 Emulium Delta; manufactured by Gattefosse, France Sodium 0.22 0.07 Analytical grade; manufactured benzoate by Merck, Germany, 0.09% in water Potassium 0.15 0.05 Analytical grade; manufactured sorbate by Fluka, Switzerland, 0.06% in water Pectin 2.44 0.75 1.00% in water, DE = 81.7% Distilled 244 74.89 water Total 325.81 100 pH of lotion: 3-4 [0262] Since the pH is low, the lotion can be preserved with conventional food-grade preservatives. [0263] Method 1: 1. Palmitate and emulsifier were mixed and heated to 75° C. in order to melt the emulsifier. 2. Pectin and preservatives were dispersed in distilled water and heated to 75° C. 3. The hot oil phase was added to the hot water phase while stirring on magnetic stirrer. 4. The mix was cooled to about 30° C. on cooling bath while stirring and fill into appropriate container. [0268] Method 2: 1. Palmitate and emulsifier were mixed and heated to 75° C. in order to melt the emulsifier. 2. Pectin was dispersed into the hot melt. Pectin is insoluble in the oil phase and consequently easy to disperse therein without formation of lumps. 3. Preservatives were dissolved in distilled water and the solution was heated to 75° C. 4. The hot oil phase was added to the hot water phase while stirring on magnetic stirrer. [0273] The mix was cooled to about 30° C. on cooling bath while stirring and fill into appropriate container. 1. A piece of cotton was cut to fit into a petri dish. 2. The cotton piece was soaked in a pectin solution in distilled water and stirred on magnetic stirrer for about 5 minutes. 3. The wet cloth was hand-pressed and placed in a petri dish. 4. The cloth was dried over night in an oven at 50° C. 5. The dried cloth was wetted with 2 ml 0.001 M NaOH. 6. A piece of indicator paper (pH in the range 1-11) was placed on the cloth. 7. The color change of the indicator paper over time was recorded. [0281] (Note: This test is indicative, only. It is not possible to read the pH accurately.) [0282] The invention will now be described in more detail with respect to the following, specific, non-limiting examples. EXAMPLES Example 1 Effect of Molecular Weight [0283] Five samples of different molecular weight, but with similar DE made from dried lemon peel were titrated and the pH drop over time recorded for samples dissolved at 70° C. and 20° C., respectively. The pH drop was measured at 30-32° C. Titration was done using 0.1008 M NaOH. The comment “unstable” refers to the pH-meter, which at high pH values showed an unstable reading. [0000] TABLE 1.1 Titration and pH drop of pectin with molecular weight 123.000, DE = 71.4% Time, Time, minutes. minutes, ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.12 0 9.83 0 9.72 1 3.19 1 9.47 1 9.4 2 3.26 2 9.27 2 9.21 3 3.33 3 9.13 3 9.08 4 3.41 4 9.03 4 8.98 5 3.48 5 8.94 5 8.9 6 3.56 18 8.39 6 8.82 7 3.63 54 7.66 19 8.29 8 3.71 72 7.38 30 8.08 9 3.8 102 7.16 62 7.44 10 3.91 175 6.86 97 7.15 11 4.02 1149 6.15 157 6.92 12 4.15 1194 6.12 193 6.85 13 4.29 14 4.48 15 4.72 16 5.13 17 6.84 17.5 8.52 Unstable 18 8.95 Unstable [0000] TABLE 1.2 Titration and pH drop of pectin with molecular weight 108.500, DE = 71.4% Time, Time, minutes, minutes, ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.12 0 9.7 0 9.64 1 3.17 1 9.44 1 9.35 2 3.24 2 9.28 2 9.16 3 3.3 3 9.13 3 9.02 4 3.37 4 9.04 4 8.91 5 3.44 5 8.93 5 8.83 6 3.52 8 8.66 15 8.3 7 3.59 22 7.98 23 8.06 8 3.68 61 7.42 30 7.81 9 3.77 101 7.02 43 7.48 10 3.87 158 6.88 56 7.32 11 3.97 188 6.84 69 7.22 12 4.09 1171 6.09 103 6.99 13 4.22 1188 6.05 159 6.82 14 4.39 210 6.74 15 4.6 16 4.91 17 5.55 17.5 7.02 Unstable 18 8.71 Unstable [0000] TABLE 1.3 Titration and pH drop of pectin with molecular weight 95.000, DE = 72.3% Time, Time, minutes, minutes, ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.03 0 9.9 0 9.57 1 3.1 1 9.55 1 9.33 2 3.15 2 9.33 2 9.18 3 3.22 3 9.22 3 9.06 4 3.29 4 9.13 4 8.97 5 3.36 5 9.04 5 8.89 6 3.43 6 8.98 6 8.82 7 3.51 13 8.61 41 7.52 8 3.59 25 8.05 49 7.38 9 3.67 31 7.87 66 7.23 10 3.77 49 7.51 78 7.16 11 3.84 66 7.34 100 7.11 12 3.95 104 7.04 141 6.96 13 4.08 128 6.95 162 6.92 14 4.2 159 6.89 172 6.92 15 4.35 1488 6.2 16 4.56 17 4.84 18 5.37 18.5 6.12 19 8.32 Unstable 19.5 8.94 Unstable [0000] TABLE 1.4 Titration and pH drop of pectin with molecular weight 71,500, DE = 71.6% Time, Time, minutes, minutes, ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.06 0 9.83 0 9.59 1 3.12 1 9.38 1 9.3 2 3.18 2 9.13 2 9.1 3 3.25 3 8.95 3 8.98 4 3.32 4 8.84 4 8.88 5 3.38 5 8.73 5 8.79 6 3.45 24 8.18 11 8.44 7 3.53 30 7.95 20 8.09 8 3.61 56 7.37 37 7.56 9 3.69 87 7.07 55 7.29 10 3.78 115 6.93 84 7.06 11 3.87 163 6.82 164 6.86 12 3.98 225 6.74 176 6.84 13 4.1 310 6.65 14 4.24 1216 6.09 15 4.4 1252 6.04 16 4.61 17 4.91 17.5 5.14 18 5.52 18.5 6.77 Unstable 19 8.63 Unstable [0000] TABLE 1.5 Titration and pH drop of pectin with molecular weight 41,500, DE = 73% Time, Time, minutes, minutes, ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.04 0 9.83 0 9.53 1 3.09 1 9.36 1 9.22 2 3.15 2 9.1 2 9.05 3 3.21 3 8.93 3 8.9 4 3.28 4 8.81 4 8.78 5 3.34 5 8.7 5 8.68 6 3.41 10 8.34 6 8.61 7 3.48 19 7.93 20 7.94 8 3.56 29 7.64 26 7.77 9 3.64 45 7.34 55 7.22 10 3.73 67 7.13 76 7.11 11 3.81 129 6.9 122 6.93 12 3.91 199 6.8 159 6.87 13 4.02 1173 5.88 261 6.73 14 4.15 1193 5.85 15 4.29 16 4.46 17 4.7 18 5.06 18.5 5.39 19 6.22 Unstable 19.5 8.47 Unstable 20 9.04 Unstable [0284] FIG. 1.1 shows that the molecular weight of pectin has no influence on the alkali consumption. [0285] The data in FIG. 1.2 do not suggest a change in the pH-drop resulting from a change in molecular weight. In practice, this means that a pH controlling preparation made from pectin can be made thick (high molecular weight) or thin (low molecular weight) or basically with any viscosity between the two extremes. In addition, if the alkali consumption is to be increased, a low molecular weight pectin preparation makes it possible to increase the concentration of pectin without making the alkali consuming preparation too viscous. [0286] FIG. 1.3 shows that dissolution temperature does not change the drop in pH. Thus, irrespective of the molecular weight, pectin preparation for controlling pH can be made either hot or cold. Example 2 Effect of Degree of Esterification [0287] Eight samples were prepared with different degree of esterification ranging from about 9 to 93%. The samples were made from dried lemon peel. All were titrated and the pH drop over time recorded for samples dissolved at 70° C. and 20° C., respectively. The pH drop was measured at 30-32° C. Titration was done using 0.1008 M NaOH. The comment “unstable” refers to the pH-meter, which at high pH values showed an unstable reading. [0000] TABLE 2.1 Titration and pH drop of pectin with DE = 9.6% Time, Time, minutes, minutes, ml NaOH pH Comment 70° C. pH 20° C. pH 0 4.07 0 9.76 0 9.62 1 4.12 1 9.69 1 9.57 2 4.16 2 9.64 2 9.54 3 4.2 3 9.59 3 9.5 4 4.24 4 9.57 4 9.48 5 4.28 12 9.31 5 9.45 6 4.33 32 9.06 7 9.41 7 4.37 74 8.56 12 9.05 8 4.42 112 8.15 22 8.92 9 4.47 1479 7.27 49 8.76 10 4.52 4093 6.26 62 8.56 11 4.57 122 7.98 12 4.64 182 7.6 13 4.7 242 7.47 14 4.77 302 7.37 15 4.86 449 7.32 16 4.96 1382 7.21 17 5.08 1412 7.18 18 5.23 19 5.45 20 5.85 21 8.17 Unstable [0000] TABLE 2.2 Titration and pH drop of pectin with DE = 34.4% Time, Time, minutes, minutes, ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.22 0 9.97 0 9.7 1 3.27 1 9.74 1 9.54 2 3.3 2 9.59 2 9.43 3 3.33 3 9.48 3 9.33 4 3.36 4 9.37 4 9.25 5 3.39 5 9.28 5 9.18 6 3.42 35 8.01 12 8.78 7 3.45 67 7.59 26 8.15 8 3.48 110 7.33 58 7.65 9 3.51 151 7.19 88 7.41 10 3.55 1483 6.54 189 7.1 11 3.58 12 3.62 13 3.65 14 3.69 15 3.74 16 3.77 17 3.82 18 3.86 19 3.9 20 3.94 21 3.98 22 4.03 23 4.08 24 4.13 25 4.17 26 4.23 27 4.28 28 4.34 29 4.4 30 4.47 31 4.54 33 4.72 35 4.97 36 5.16 37 5.45 38 6.2 39 9.76 Unstable [0000] TABLE 2.3 Titration and pH drop of pectin with DE = 71% Time, Time, minutes, minutes, ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.11 0 10.21 0 9.73 0.2 3.12 0.5 9.85 1 9.24 0.42 3.14 1 9.65 2 8.92 0.6 3.15 2 9.35 3 8.68 0.84 3.17 3 9.1 4 8.48 1.2 3.2 8 8.39 9 7.88 1.6 3.23 10 8.21 14 7.56 2.08 3.27 20 7.73 23 7.23 2.4 3.29 31 7.5 33 7.07 3 3.34 45 7.3 44 6.96 3.4 3.37 75 7.12 48 6.94 4 3.42 115 7 4.8 3.49 150 6.91 5.68 3.56 190 6.86 6.02 3.59 260 6.85 6.6 3.64 285 6.82 7.6 3.73 320 6.78 8 3.76 360 6.75 9 3.86 390 6.73 10 3.97 10.4 4 11 4.07 12 4.2 13 4.34 14 4.52 15 4.73 16 5.08 16.6 5.43 17 5.95 17.4 8.12 Unstable 17.6 9 Unstable [0000] TABLE 2.4 Titration and pH drop of pectin with DE = 93.4% Time, Time, minutes, minutes, ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.26 0 9.5 0 9.29 1 3.43 1 8.89 1 8.14 2 3.65 2 8.14 2 7.7 3 3.98 3 7.77 3 7.49 4 4.54 4 7.58 4 7.33 5 8.74 Unstable 5 7.45 5 7.21 11 7.04 8 7 15 6.9 13 6.81 20 6.79 23 6.61 25 6.7 33 6.51 30 6.62 1004 5.37 38 6.52 1018 5.3 [0288] FIG. 2.1 shows that one pectin is characterized by a higher starting pH than the rest. Conventionally, pectin is neutralized with an alkali metal base to a pH in the range 3-4 or even higher. This is mainly in order to preserve the pectin, but it also has an impact on the solubility of the pectin. However, if one moves the curve for DE=9.6% upwards to connect with the other curves, the picture becomes clear: With increasing DE and consequently decreasing galacturonic acid, the pectin can consume less alkali. Thus, if pectin is used to neutralize alkali, the degree of esterification and the starting pH should be as low as possible. [0289] To further elaborate on this point, I define buffer capacity as ml. 0.1 M NaOH required to increase the pH by 1 pH unit, calculated from the part of the titration curve, which is steepest. [0290] Thus, the approximate buffer capacities as calculated from FIG. 2.1 are: [0291] DE=9.6% and DE=34.4%: Buffer capacity about 26 [0292] DE=71%: Buffer capacity about 12 [0293] DE=93.4%: Buffer capacity less than 6 [0294] FIG. 2.2 show a dramatic increase in the pH-drop as the degree of esterification is increased. [0295] FIG. 2.3 shows the same dramatic influence of DE even when the pectin is dissolved at 20° C. The figure shows that at the high DE, the pH is eventually decreased below 5.5. [0296] These results are compiled in FIG. 2.4 , in which the pH drop has been followed for the first up to about 130 minutes. It is evident that the pH-drop occurs to the same extent whether the pectin solution is made hot or cold. [0297] For DE=93.4%, time to reach pH=8 is 2 minutes, for DE=71% it takes 12 minutes, for DE=34.4% the time is 35 minutes and for DE=9.6% it takes 130 minutes. In order to reach pH=7, the difference is even bigger. Pectin with a DE=71 is about 9 times slower than pectin with DE=93.4, and pectin with DE lower than 71% are slower than a factor 10 compared to pectin with DE=93.4. [0298] Thus, if one needs to obtain a rapid pH decrease as a result of alkali generation, pectin with as high a DE as possible is preferred. If, on the other hand, the need calls for slower reduction of pH, then a lower DE would be preferred. Selecting pectin of a specific DE makes it possible to reduce the pH at a specific rate. [0299] Another aspect is to combine pectin preparations of different DE. For example, one might combine a low DE pectin and a high DE pectin to achieve initial alkali consumption or buffer capacity and to provide pH reduction, when the buffer capacity is used. Example 3 Effect of Methyl Ester Distribution [0300] Two samples were made from dried lemon peel. One was de-esterified with a bacterial pectin esterase, which results in a random distribution of the methyl ester groups. The other was de-esterified with a plant pectin esterase, which results in a block wise distribution of the methyl ester groups. The samples were made to similar DE. Both samples were titrated and the pH drop over time recorded for samples dissolved at 70° C. and 20° C., respectively. The pH drop was measured at 30-32° C. Titration was done using 0.1008 M NaOH. The comment “unstable” refers to the pH-meter, which at high pH values showed an unstable reading. [0301] FIG. 3.1 shows that the distribution of methyl esters in pectin has no impact on the alkali consumption. The galacturonic acid drives the alkali consumption. [0302] FIG. 3.2 indicates a difference in the rate of the pH-drop. It also shows, that identical pH-drop is achieved whether the pectin has been dissolved hot or cold. [0303] FIG. 3.3 shows the pH-drop in the first 120-130 minutes, and a random ester group distribution needs about 4 times longer to reach pH=8 compared to a blocky ester group distribution. Since the two pectin preparations have almost identical average DE, the faster pH-drop of a blocky ester distribution is explained by local concentration of ester groups. Thus, pectin with a blocky ester distribution will act as pectin with a higher average DE. In practice, this is important because one might treat a blocky pectin with polygalacturonase to increase the DE, which would constitute an easier way to make a high ester pectin than by using the process of re-methylation. Example 4 Effect of Temperature [0304] The pH drop for one sample having DE=71% and made from dried lemon peel was recorded at four different temperatures. The sample was prepared by dissolving the pectin at 70° C. and subsequently cooling the solution to the recording temperature. The temperature was maintained with a thermostatically controlled water bath. [0000] TABLE 4.1 pH drop of pectin with DE = 71% at various temperatures 25-27° C. 30-32° C. 35-37° C. 45-47° C. Time, Time, Time, Time, minutes pH minutes pH minutes pH minutes pH 0.2 10.4 0 10.21 0 10.08 0 10.01 0.5 10.21 0.5 9.85 1 9.41 1 9.15 1 9.85 1 9.65 2 9.01 2 8.59 2 9.52 2 9.35 3 8.73 3 8.26 3 9.26 3 9.1 10 7.81 4 8.04 5 8.89 8 8.39 23 7.4 9 7.49 10 8.33 10 8.21 35 7.23 16 7.15 20 7.75 20 7.73 143 6.75 21 7.02 30 7.47 31 7.5 203 6.64 44 6.78 45 7.24 45 7.3 263 6.57 61 6.68 60 7.11 75 7.12 326 6.5 76 6.62 122 6.91 115 7 378 6.45 121 5.5 181 6.85 150 6.91 154 6.43 240 6.79 190 6.86 202 6.34 291 6.77 260 6.85 250 6.27 347 6.74 285 6.82 325 6.17 1298 6.32 320 6.78 420 6.06 1428 6.31 360 6.75 1508 6.3 390 6.73 1553 6.28 [0305] FIG. 4.1 shows that the rate of the pH-drop increases with increasing temperature. The rate is particularly increased as the temperature increases above about 30° C. Example 5 Effect of Multiple Additions of Alkali [0306] The pH drop for one sample having DE=71% and made from dried lemon peel was recorded at a temperature of 25-27° C. First, the pH was raised to about 10 with 19 ml. 0.1 M NaOH. When the sample had reached a pH of 6-7, the pH was again raised to about 10. This required 1.1 ml. 0.1 M NaOH. When the pH had reached 6-7, the pH was raised a third time to about 10, which required 1.2 ml. 0.1 M NaOH. The sample was prepared by dissolving the pectin at 70° C. and subsequently cooling the solution to the recording temperature. The temperature was maintained with a thermostatically controlled water bath. [0000] TABLE 5.1 Multiple pH drop of pectin with DE = 71% First dosage; Second dosage; Third dosage: 19 ml 0.1M 1.1 ml 0.1M 1.2 ml 0.1M KaOH NaOH NaOH Time, Time, Time, minutes pH minutes pH minutes pH 0.2 10.4 0 10.08 0 10.22 0.5 10.21 0.5 9.88 2 9.63 1 9.85 1 9.71 7 8.76 2 9.52 2 9.44 12 8.32 3 9.26 5 8.93 32 7.64 5 8.89 10 8.36 67 7.17 10 8.33 20 7.73 92 7.07 20 7.75 40 7.32 152 6.93 30 7.47 70 7.06 212 6.87 45 7.24 85 6.97 272 6.82 60 7.11 175 6.65 332 6.78 122 6.91 1140 6.38 402 6.74 181 6.85 1165 6.37 482 6.74 240 6.79 291 6.77 347 6.74 1298 6.32 1428 6.31 1508 6.3 1553 6.28 [0307] FIG. 5.1 shows that the rate of the pH-drop stays unchanged after at least three cycles, where the pH is first increased to about 10, then after the pH has dropped increased to about 10. After one cycle, the DE is decreased to about 66%, so the ability to continue reducing pH is caused by an incomplete de-esterification. [0308] Thus, if alkalinity is appears in pulses, for at least three times pectin is able to reduce the alkali. In fact, in one experiment, which went on for seven days, a 200 ml. 1% pectin solution of DE=71% consumed 73 ml. of a 0.1 M NaOH solution. After this period, the DE has decreased to 9.1%. [0309] Thus, 2 g. pectin consumes 7.3 mmol NaOH, which corresponds to about 0.3 g. NaOH. It also means that about 0.23 g. methanol is produced, which in combination with the acid effect of pectin may explain the anti-microbial effect of pectin. Example 6 Effect of Pectin Concentration [0310] The pH drop for one sample having DE=81.7% and made from dried lemon peel was recorded at a temperature of 30-32° C. The concentration of pectin was 0.05-2%. The sample was prepared by dissolving the pectin at 70° C. and subsequently cooling the solution to the recording temperature. The temperature was maintained with a thermostatically controlled water bath. [0000] TABLE 6.1 pH drop at different concentration of pectin solution with DE = 81.7% 0.05% 0.1% 0.2% 0.5% 1.0% 2.0% Start Start Start Start Start Start pH = 3.62 pH = 3.70 pH = 3.46 pH = 3.15 pH = 2.96 pH = 2.87 0.8 ml 0.1M 0.8 ml 0.1M 1.7 ml 0.1M 4.4 ml 0.1M 7.6 ml 0.1 M 15.5 ml 0.1M NaOH NaOH NaOH NaOH NaOH NaOH Minutes pH Minutes pH Minutes pH Minutes pH Minutes pH Minutes pH 0 9.89 0 9.89 0 9.98 0 10.1 0 9.8 0 10.02 1 9.87 1 9.63 1 9.67 1 9.72 1 9.26 1 9.34 2 9.82 2 9.55 2 9.52 2 9.45 2 8.95 2 8.95 3 9.7 3 9.47 3 9.38 3 9.23 3 8.69 3 8.66 4 9.66 4 9.4 4 9.25 4 9.03 4 8.48 4 8.43 5 9.63 5 9.32 5 9.14 5 8.89 5 8.3 5 8.22 11 9.42 9 9.09 11 8.6 12 8.1 9 7.87 9 7.75 21 9.19 19 8.59 16 8.2 22 7.66 19 7.51 19 7.39 31 9 29 8.12 26 7.72 32 7.5 29 7.38 29 7.25 41 8.81 39 7.72 36 7.48 42 7.39 39 7.27 39 7.18 51 8.63 49 7.58 46 7.35 52 7.33 49 7.19 49 7.13 61 8.33 59 7.45 61 7.24 62 7.27 59 7.13 59 7.1 [0311] FIG. 6.1 shows that at pectin concentrations above 1%, the pH-drop appears to be independent of the pectin concentration. However, even at very low concentrations of pectin, a clear drop in pH occurs. Example 7 ph Drop of Water [0312] Carbon dioxide is soluble in water, and this experiment shows the pH drop of ion-exchanged water over time without the presence of pectin or other additions. The temperature of the water was kept at 25° C. using a thermostatically controlled water bath. [0000] TABLE 7.1 pH drop of ion exchanged water Time, minutes pH 0 10.67 18 10.63 36 10.57 56 10.56 81 10.55 125 10.43 165 10.3 297 10.23 330 10.07 [0313] FIG. 7.1 shows that over a period of about 5 hours, the “natural” drop of pH in water is about 0.5 pH-units, so the error is tolerable. Example 8 Propylene Glycol Alginate Effect of Esterification [0314] Three samples with degree of esterification ranging from about 55 to about 85% were tested. All were titrated and the pH drop over time recorded for samples dissolved at 70° C. and 20° C., respectively. The pH drop was measured at 30-32° C. Titration was done using 0.1008 M NaOH. The comment “unstable” refers to the pH-meter, which at high pH values showed an unstable reading. [0000] TABLE 8.1 Titration and pH drop of high DE PGA (Kelcoloid O. Esterification: High - about 85%) Time, Time, minutes minutes ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.89 0 10 0 10.19 0.5 3.99 1 7.77 1 7.74 1 4.1 2 7.34 2 7.33 1.5 4.22 3 7.14 3 7.13 2 4.38 4 7 4 6.99 2.5 4.57 5 6.89 5 6.86 3 4.89 10 6.48 8 6.57 3.5 5.7 15 6.2 38 5.41 4 8.82 Unstable 25 5.81 68 5.07 53 5.29 132 4.77 70 5.12 1102 4.4 90 4.99 1142 4.4 116 4.89 127 4.85 [0000] TABLE 8.2 Titration and pH drop of high DE PGA (Manned Ester ER/K. Esterification: High - about 80%.) Time, Time, minutes minutes ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.76 0 10 0 10.2 0.5 3.82 1 7.85 1 7.97 1 3.91 2 7.38 2 7.44 1.5 4.01 3 7.17 3 7.23 2 4.11 4 7 4 7.08 2.5 4.24 5 6.87 5 6.95 3 4.39 7 6.66 9 6.58 3.5 4.58 12 6.29 15 6.26 4 4.89 17 6.03 31 5.75 4.5 5.63 27 5.69 59 5.28 5 8.88 Unstable 42 5.4 90 5.06 57 5.24 142 4.87 1114 4.54 1163 4.53 [0000] TABLE 8.3 Titration and pH drop of medium DE PGA (Kelcoloid HVF. Esterification: Medium - about 55%) Time, Time, minutes minutes ml NaOH pH Comment 70° C. pH 20° C. pH 0 3.81 0 10.21 0 10.29 0.5 3.85 1 8.66 1 8.78 1 3.9 2 7.98 2 8.07 1.5 3.95 3 7.65 3 7.72 2 4 4 7.47 4 7.51 2.5 4.06 5 7.35 5 7.37 3 4.12 7 7.16 7 7.16 3.5 4.19 12 6.82 12 6.82 4 4.26 27 6.3 27 6.27 4.5 4.34 47 5.91 52 5.84 5 4.43 67 5.69 77 5.63 5.5 4.53 97 5.5 95 5.53 6 4.66 152 5.31 1106 5.02 6.5 4.82 222 5.19 1148 5.02 7 5.07 7.5 5.56 8 8.03 Unstable [0315] The pH drop for one sample, Manucol Ester ER/K, was recorded at a temperature of 30-32° C. First, the pH was raised to about 10 with 4 ml. 0.1 M NaOH. When the sample had reached a pH of 5-6, the pH was again raised to about 10. This required 2.5 ml. 0.1 M NaOH. When the pH had reached 5-6, the pH was raised a third time to about 10, which required 2.0 ml. 0.1 M NaOH. When the pH had reached about 6, the pH was again increased to about 10, which required 1.5 ml. NaOH. The sample was prepared by dissolving the pectin at 70° C. and subsequently cooling the solution to the recording temperature. The temperature was maintained with a thermostatically controlled water bath. [0000] TABLE 8.4 Multiple pH drop of high DE PGA First dosage Second dosage: Third dosage: Fourth dosage: 4 ml 0.1M 2.5 ml 0.1M 2.0 ml 0.1M 1.5 ml 0.1M NaOH NaOH NaOH NaOH Time, Time, Time, Time, minutes pH minutes pH minutes pH minutes pH 0 10 0 10.24 0 9.89 0 9.97 1 7.85 1 8.29 1 8.26 1 8.7 2 7.38 2 7.62 2 7.64 2 8.04 3 7.17 3 7.36 3 7.37 3 7.67 4 7 4 7.2 4 7.21 4 7.47 5 6.87 5 7.07 5 7.09 5 7.33 7 6.66 9 6.64 9 6.7 11 6.84 12 6.29 14 6.29 13 6.45 16 6.56 17 6.03 19 6.04 18 6.23 22 6.31 27 5.69 24 5.85 23 6.06 31 6.03 42 5.4 147 5.13 57 5.24 [0316] FIG. 8.1 shows that as the degree of esterification increases in PGA, the less alkali can be consumed. [0317] Buffer Capacities are Calculated to [0318] PGA with DE about 85%: About 4.1 [0319] PGA with DE about 80%: About 5.7 [0320] PGA with DE about 55%: About 8.1 [0321] Thus, PGA provides less buffering effect compared to pectin. [0322] FIG. 8.2 shows that as for pectin, PGA provides a faster pH drop with increasing degree of esterification. [0323] FIG. 8.3 shows the same dramatic influence of esterification even when the propylene glycol alginate is dissolved at 20° C. The figure shows that at the high DE, the pH is eventually decreased to below 5. [0324] FIG. 8.4 shows that the pH-drop occurs to the same extent whether the propylene glycol alginate solution is made hot or cold. Example 9 Effect of Multiple Additions of Alkali to Propylene Glycol Alginate [0325] The pH drop for one sample, Manucol Ester ER/K, was recorded at a temperature of 30-32° C. First, the pH was raised to about 10 with 4 ml. 0.1 M NaOH. When the sample had reached a pH of 5-6, the pH was again raised to about 10. This required 2.5 ml. 0.1 M NaOH. When the pH had reached 5-6, the pH was raised a third time to about 10, which required 2.0 ml. 0.1 M NaOH. When the pH had reached about 6, the pH was again increased to about 10, which required 1.5 ml. NaOH. The sample was prepared by dissolving the pectin at 70° C. and subsequently cooling the solution to the recording temperature. The temperature was maintained with a thermostatically controlled water bath. [0000] TABLE 9.1 Multiple pH drop of high DE PGA First dosage Second dosage: Third dosage: Fourth dosage: 4 ml 0.1M 2.5 ml 0.1M 2.0 ml 0.1M 1.5 ml 0.1M NaOH NaOH NaOH NaOH Time, Time, Time, Time, minutes pH minutes pH minutes pH minutes pH 0 10 0 10.24 0 9.89 0 9.97 1 7.85 1 8.29 1 8.26 1 8.7 2 7.38 2 7.62 2 7.64 2 8.04 3 7.17 3 7.36 3 7.37 3 7.67 4 7 4 7.2 4 7.21 4 7.47 5 6.87 5 7.07 5 7.09 5 7.33 7 6.66 9 6.64 9 6.7 11 6.84 12 6.29 14 6.29 13 6.45 16 6.56 17 6.03 19 6.04 18 6.23 22 6.31 27 5.69 24 5.85 23 6.06 31 6.03 42 5.4 147 5.13 57 5.24 [0326] FIG. 9.1 shows a tendency for the pH-drop to become slower after two cycles. Example 10 ph-Drop in Lotion [0327] The pH drop in lotions made according to the two methods described in “Materials and Methods” section 2.1 were measured using pectin of about DE=81.7%. [0328] 10 grams lotion was slurried in 50 ml distilled water and pH was adjusted with 0.1 M NaOH to about 10. Pectin concentration in slurry: 0.125%. Temperature: 30° C. [0000] TABLE 10.1 pH-drop of lotions Method 1 Method 2 Minutes pH Minutes pH 0 9.98 0 10.24 1 9.84 1 10.07 2 9.78 2 9.97 3 9.68 3 9.89 4 9.63 4 9.83 5 9.58 5 9.78 17 9.28 10 9.59 32 9.15 25 9.38 50 9.04 40 9.24 62 9 55 9.15 [0329] It may seem that when pectin is dissolved in the water phase before mixing with the oil phase provides for a more rapid pH-drop. However, when taking into consideration, that the curve for pectin dissolved in the water phase starts at a slightly lower pH, the two curves are close to identical. Thus, there is nothing to suggest that one of the methods for making the lotion influences the effect of the pectin. [0330] The lotions were tested by 12 persons—6 females and 6 males, with the following remarks from the test persons: [0331] Easy to Spread on the Skin [0332] Non-sticky [0333] Non-greasy [0334] Softens skin within one minute after application [0335] Skin-softening remains for at least 24 hours [0336] Removes skin-itching within one minute after application [0337] Skin-itching does not reoccur within 24 hours [0338] Athlete's foot is effectively combated for at least 24 hours [0339] The lotion was also tested on one dog, which had developed a rash on the nose. Treatment of the nose with the lotion twice for one day reduced the rash visibly. To similar treatments over the next two days reduced to rash to an extent, where the rash was difficult to see. Example 11 ph-Drop of Cloth [0340] Cloths were prepared according to the method in “Materials and Methods” section above. [0000] TABLE 11.1 pH-drop of cloth soaked in a 0.01% pectin solution 0.01% pectin Mw = 123,000 Mw = 95,000 Mw = 41,500 Mw = 25,000 Minutes pH Minutes pH Minutes pH Minutes pH 0 11 0 11 0 11 0 11 20 9 20 9 20 9 20 9 140 8.5 140 8.5 140 8.5 140 8.5 290 8 290 8 290 8 290 8 500 7.5 500 7.5 500 7.5 500 7.5 [0000] TABLE 11.2 pH-drop of cloth soaked in a 0.05% pectin solution 0.05% pectin Mw = 123,000 Mw = 95,000 Mw = 41,500 Mw = 25,000 Minutes pH Minutes pH Minutes pH Minutes pH 0 11 0 11 0 11 0 11 20 9 20 9 20 9 20 9 140 8.5 140 8.5 140 8.5 140 8.5 290 8 290 8 290 8 290 8 500 7.5 500 7.5 500 7.5 500 7.5 [0000] TABLE 11.3 pH-drop of cloth soaked in a 0.10% pectin solution 0.10% pectin Mw = 123,000 Mw = 95,000 Mw = 41,500 Mw = 25,000 Minutes pH Minutes pH Minutes pH Minutes pH 0 11 0 11 0 11 0 11 20 9 20 9 20 9 20 9 140 8.5 140 8.5 140 8.5 140 8.5 290 8 290 8 290 8 290 8 500 7.5 500 7.5 500 7.5 500 7.5 [0000] TABLE 11.4 pH-drop of cloth soaked in a 0.20% pectin solution 0.20% pectin Mw = 123,000 Mw = 95,000 Mw = 41,500 Mw = 25,000 Minutes pH Minutes pH Minutes pH Minutes pH 0 11 0 10 0 11 0 11 20 9 20 8.5 20 8.5 20 9 140 8.5 140 8 140 8 140 8.5 290 8 290 7.5 290 8 290 8 500 7.5 500 7 500 7.5 500 7.5 [0000] TABLE 11.5 pH-drop of cloth soaked in a 0.50% pectin solution 0.50% pectin Mw = 123,000 Mw = 95,000 Mw = 41,500 Mw = 25,000 Minutes pH Minutes pH Minutes pH Minutes pH 0 10 0 10 0 10 0 10 20 8.5 20 8.5 20 8.5 20 8.5 140 8 140 8 140 8 140 8 290 7.5 290 7.5 290 7.5 290 7.5 500 7 500 7 500 7 500 7 [0341] FIGS. 11 . 1 - 11 . 5 show that irrespective of the concentration of pectin during soaking, and irrespective of the molecular weight of the pectin, the pH-drop is quite similar. [0342] However, when the cloth is soaked in a pectin solution, the dried cloth becomes stiffer. Table 11.1 shows this effect: [0000] TABLE 11.1 Stiffness of cloth as a function of pectin concentration in soak and molecular weight of pectin Pectin M W % in soak 123,000 95,000 41,500 25,000 0.01 Soft Soft Soft Soft 0.05 Slightly Soft Soft Soft soft 0.1 Acceptable Soft Soft Soft 0.2 Stiff Acceptable Soft Soft 0.5 Too stiff Stiff Acceptable Acceptable [0343] Table 11.1 shows that as the molecular weight decreases, the cloth can contain more pectin without becoming unacceptably stiff. Mw=123,000 becomes unacceptably stiff at concentrations in the soak above 0.10% Mw=95,000 becomes unacceptably stiff at concentrations in the soak above 0.20% Mw=41,500 and Mw=25,000 become unacceptably stiff at concentrations in the soak above 0.50%. [0347] A rinse is normally performed using 16 liters of water. Assuming that the rinse dosage is 100 ml, then 0.01% pectin in the rinse corresponds to a pectin solution of 1.57%. 0.05% pectin in the rinse corresponds to a pectin solution of 7.4%. 0.10% pectin in the rinse corresponds to a pectin solution of 13.79%. 0.20% pectin in the rinse corresponds to a pectin solution of 26.47% and 0.05% pectin in the rinse corresponds to a pectin solution of 44.44%. [0348] The effect on Brookfield viscosity of such pectin solutions are shown in table 11.2: [0000] TABLE 11.2 Viscosity of different molecular weights of pectin at various concentrations Sample % Viscosity, cP Comment Mw = 123,00 1.6 229 4 12880 Not fully dissolved Mw = 95,000 1.6 99.5 4 2840 Not fully dissolved Mw = 41,500 1.6 11.3 4 73.6 8 790 12 19200 Not fully dissolved Mw = 25,000 1.6 7.8 4 29.2 8 270 12 3560 Thick but dissolved 16 26800 Not fully dissolved [0349] It is clear that as the molecular weights drops, it becomes easier to dissolve the pectin, and in addition the viscosity becomes lower. This enables a rinse to contain more pectin in lower rinse dosage. [0350] For pectin with a molecular weight of 123,000, the maximum concentration of pectin in the rinse is about 2%, for a pectin with a molecular weight of 95,000, the maximum concentration of pectin in the rinse is about 3%, for a pectin with molecular weight of 41,500, the maximum concentration of pectin in the rinse is about 10% and for a pectin with molecular weight of 25,000, the maximum concentration of pectin in the rinse is about 12%. Example 12 Effect of Blending Pectin Products [0351] Pectin products having a DE of 93.4% and 9.6%, respectively were blended 1:1 and 100 g. 1% solution was prepared of the blend through heating to 70° C. The consumption of alkali at 25° C. and the pH-drop over time at 30-32° C. was recorded. Titration was done using 0.1008 M NaOH. The comment “unstable” refers to the pH-meter, which at high pH values showed an unstable reading. [0000] TABLE 12 Titration and pH drop of pectin blends Time, ml. NaOH pH Comment minutes pH 0 4.26 0 110.00 1 4.27 1 9.31 2 4.33 2 8.98 3 4.40 3 8.76 4 4.48 4 8.58 5 4.56 5 8.44 6 4.64 16 7.66 7 4.74 40 7.33 8 4.85 49 7.22 9 4.97 69 7.04 10 5.12 11 5.33 12 5.66 13 6.82 Slightly unstable 14 9.73 Unstable [0352] FIG. 12.1 shows that blending high DE pectin and low DE pectin results in an alkali consumption in between the alkali consumption of the individual pectin products. [0353] FIG. 12.2 shows that the pH drop over time falls between the pH drop over time of the individual components. [0354] Compared to the individual components, the blend of high DE pectin and low DE pectin provides for an increase in alkali consumption compared to pure high DE pectin and an increase in pH-drop compared to low DE pectin. Example 13 Effect of Blending High Ester Pectin and Low Ester Propylene Glycol Alginate [0355] A blend of 50% of a pectin having a DE of 93.4% and 50% of a propylene glycol alginate (PGA) having a DE of 55% was dissolved at 70% in a similar manner as in example 12 and compared with the alkali consumption of the individual components. [0000] TABLE 13 Titration and pH drop of blend of high ester pectin and low ester propylene glycol alginate. Time, ml. NaOH pH Remarks minutes pH 0 3.66 0 10.00 1 3.77 1 9.24 2 3.9 2 8.51 3 4.05 3 8.05 4 4.22 4 7.76 5 4.46 5 7.57 6 4.83 7 7.34 7 6.47 Slightly 18 6.79 unstable 8 9.89 Unstable 28 6.55 97 5.87 [0356] FIG. 13.1 shows that the alkali consumption falls between the alkali consumption of the individual components, but the use of a mixture of a high DE pectin and a medium DE PGA results in a smaller increase in alkali consumption than observed with the mixture of a high DE pectin and a low DE pectin of example 12. [0357] FIG. 13.2 shows that the pH-drop of the blend falls between the pH-drop of the individual components. However, even a relatively low esterified PGA provides for a faster pH-drop than a much higher esterified pectin. [0358] Compared with the individual components the blend provides an increase in alkali consumption compared to the pectin product alone. Example 14 Effect of Blending High De Propylene Glycol Alginate and Low DE Pectin [0359] A blend of 50% of a propylene glycol alginate (PGA) having a DE of 85% and 50% of a pectin having a DE of 9.6% was dissolved at 70% in a similar manner as in example 12 and compared with the alkali consumption of the individual components. [0000] TABLE 14 Titration and pH drop of blend of high ester propylene glycol alginate and low ester pectin Time, ml. NaOH pH Remarks minutes pH 0 4.06 0 10 1 4.12 1 9.04 2 4.18 2 8.55 3 4.25 3 8.22 4 4.33 4 7.97 5 4.4 5 7.79 6 4.49 20 6.9 7 4.57 34 6.6 8 4.68 44 6.47 9 4.8 69 6.25 10 4.94 93 6.12 11 5.13 12 5.41 13 6.5 Unstable 14 9.29 Unstable [0360] FIG. 14.1 shows that the alkali consumption of the blend falls in between the alkali consumption of the individual components. [0361] FIG. 14.2 shows that the pH drop over time falls between the pH-drop of the individual components. [0362] Compared to the individual components, the blend provides for an increase in alkali consumption compared to propylene glycol alginate alone, and an increase in pH drop compared to low DE pectin alone. [0363] 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

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present invention is a divisional of U.S. patent application Ser. No. 12/495,851, entitled “Method of Making Nanostructured Glass-Ceramic Waste Forms, filed Jul. 1, 2009, which application was related to U.S. patent application Ser. No. 12/127,111, entitled “Nanocomposite Materials as Getter and Waste Form for Radionuclides and Other Hazardous Materials”, filed May 27, 2008, and both applications are incorporated by reference herein. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] The Government has rights to this invention pursuant to Contract No. DE-AC04-94AL85000 awarded by the U.S. Department of Energy. FIELD OF THE INVENTION [0003] The present invention relates to waste forms and methods of disposal and isolation of hazardous wastes, particularly radionuclides. BACKGROUND OF THE INVENTION [0004] One of the great concerns in nuclear energy development throughout the world is the safe disposal and isolation of spent fuels from reactors or waste streams from reprocessing plants. In particular, entrapment of highly volatile radionuclides such as iodine ( 129 I) produced from a fission process and subsequent immobilization of these radionuclides in an appropriate waste form is a great technical challenge because of the high mobility of these radionuclides and the difficulty of incorporating them into any existing waste forms such as glass, ceramics, and grout. Furthermore, a majority (>99%) of 129 I will enter into the dissolver off-gas stream during fuel reprocessing. It is thus desirable to develop a material that can effectively entrap gaseous iodine during the off-gas treatment, which then can be directly converted into a durable waste form. [0005] The present invention provides a new concept of applying nanomaterial and nanotechnology to radioactive waste treatment, especially, a method for converting the radioactive nuclide-loaded mesoporous material into a glass-ceramic waste form that can be used either for interim storage or long-term disposal. The invention first fixes iodine inside the nanopores of a getter material by converting molecular iodine into less volatile ionic species. It then vitrifies the nuclides-loaded getter material with additional glass-forming components or commercially available glass frits (e.g., those from Ferro Co.). Preferred compositions and vitrification temperatures (850 to 950° C.) have been established in terms of the durability of the resulting waste form. This has been accomplished by studying various material combinations, the routes for iodine fixation, and different vitrification temperatures. FTIR, EDXRF, high temperature XRD (HTXRD), TEM, XPS, and TGA/DTA have been employed to characterize nuclide behaviors and material structures. It has been found that the formation of nanometer crystalline phases is responsible for iodine immobilization and retention during vitrification and waste form leaching. This is consistent with the determined optimal vitrification temperatures, which are lower than conventional glass-forming temperatures. BRIEF SUMMARY OF THE INVENTION [0006] The present invention is of a method of rendering hazardous materials less dangerous, comprising: trapping the hazardous material in nanopores of a nanoporous composite material; reacting the trapped hazardous material to render it less volatile/soluble; sealing the trapped hazardous material; and vitrifying the nanoporous material containing the less volatile/soluble hazardous material. In the preferred embodiment, the nanoporous composite material comprises mesoporous alumina with pore sizes up to maximum of about 50 nm and/or derivatives of mesoporous alumina with pore sizes up to maximum of about 50 nm. The derivatives preferably comprise one or more oxides of transition metals selected from the group consisting of silver (Ag), copper (Cu), iron (Fe), nickel (Ni), zinc (Zn), cobalt (Co), zirconium (Zr), and bismuth (Bi). The nanoporous composite material preferably comprises one or more glass forming oxides, more preferably selected from the group consisting of SiO 2 , Na 2 O, K 2 O, CaO, MgO, B 2 O 3 , Li 2 O, and P 2 O 5 , and most preferably wherein the one or more glass forming oxides are in percentages by weight about 0-2% Al 2 O 3 , 12-15% B 2 O 3 , 7-9% Li 2 O, 7-9% Na 2 O, and 68-72% SiO 2 . The hazardous material preferably comprises a radionuclide, more preferably one or multiple hazardous species in the form of gaseous or soluble ions, and most preferably one or both of 129I and 99Tc. The vitrifying step occurs at a temperature lower than 1100 degrees C., preferably between about 750 and 950 degrees C. (most preferably between about 800 and 900 degrees C.) or between about 850 and 950 degrees C. Leaching tests are conducted to choose optimal compositions of matter for durability of the vitrified materials. Compositions of matter that result in stable crystals are introduced, such as lithium oxide. Reacting comprises reacting the hazardous material with an alkaline reagent (most preferably alkaline metal hydroxide) and/or with sodium or potassium silicate. The invention is also of compositions of matter manufactured according to the above method. [0007] The invention is also of a method of rendering hazardous materials less dangerous, comprising: trapping the hazardous material in nanopores of a nanoporous composite material; reacting the trapped hazardous material to render it less volatile/soluble; and sealing the trapped hazardous material; thereby creating a precursor for a subsequent vitrification process. In the preferred embodiment, the hazardous material comprises a radionuclide, more preferably one or multiple hazardous species in the form of gaseous or soluble ions, and most preferably one or both of 129I and 99Tc. Reacting comprises reacting the hazardous material with sodium or potassium silicate or with sodium or potassium hydroxide. This causes a phase change of the hazardous material, confines the hazardous material to nanopores, and reduces solubility of the hazardous material (by changing oxidative state of the hazardous material). Reacting causes one or more of: causing a phase change of the hazardous material, confining the hazardous material to nanopores, and reducing solubility of the hazardous material. Pore sealing reacts the hazardous material with sodium or potassium silicate. [0008] Further scope of applicability of the present invention will be set forth in part in the detailed description to follow, taken in conjunction with the accompanying drawings, and in part will become apparent to those skilled in the art upon examination of the following, 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. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0009] The accompanying drawings, which are incorporated into and form a part of the specification, illustrate one or more embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for the purpose of illustrating one or more preferred embodiments of the invention and are not to be construed as limiting the invention. In the drawings: [0010] FIG. 1 is a graph of iodine adsorption isotherm of mesoporous alumina; measurements were made after overnight desorption at 90° C. following adsorption; [0011] FIG. 2 shows FTIR spectra of iodine in different materials/compounds; molecular iodine was converted into ionic species after fixation; [0012] FIGS. 3( a )- 3 ( d ) illustrate morphology of glass-ceramic waste forms made according to the invention; with increased sintering temperature, the color of the resulting material changes from brown to pale white; the size of vesicles also appears to increase; [0013] FIG. 4( a ) shows XRD patterns of glass-ceramic waste forms showing the crystallinity change with increasing vitrification temperatures; quartz, crystoballite and lithium silicate occur in the 750° C. sample; these phases disappear at 900° C. as the amorphous phase becomes more and more predominant; [0014] FIG. 4( b ) is a schematic diagram of crystal phase changes occurring for 510 glass frit; [0015] FIGS. 5( a )- 5 ( c ) show TEM images and EDS of a glass-ceramic waste form; FIG. 5( a ) shows nanocrystals of an Al—Bi—Re embedded in silica matrix of the glass-ceramic waste form after vitrified at 900° C.; FIGS. 5( b ) and ( c ) are, respectively, the electron diffraction pattern indicating the existence of nanocrytallites and EDS showing the embedded iodine in the matrix of Al—Si—O; Lithium is not shown due to lower atomic number; Cu signal is from sample; samples are vitrified at 900° C. grid; [0016] FIG. 6 shows HTXRD patterns of ceramic-glass forming mixtures; temperature was raised from room temperature 50° C. steps to 800° C. at 50° C./min; [0017] FIGS. 7 and 8 show rhenium (as a chemical analog to Tc) waste forms according to the invention without and with sodium silicate pretreatment; [0018] FIG. 9 shows pore size and volume distribution before fixation; [0019] FIG. 10 shows pore size and volume distribution after fixation; >90% of nanopores are effectively sealed; [0020] FIG. 11 shows XPS spectrum showing iodine binding energy; and [0021] FIG. 12 is an XPS high resolution spectrum showing the composition of I(−1) and entrapped I(0) in the nanopores (the sample has been on shelf for 1.5 year at room temperature without vitrification). DETAILED DESCRIPTION OF THE INVENTION [0022] The present invention is of a method of making nanostructured glass-ceramic waste forms that can be used for disposition of various radionuclides, especially iodine, and of the resulting waste form. The method is based on the previous invention of using mesoporous alumina and its derivatives as getter materials for entrapping gaseous iodine (U.S. patent application Ser. No. 12/127,111). In the present invention, iodine sorbed on mesoporous material is first fixed with sodium silicate to convert molecular iodine into less volatile ionic species. The resulting material is then vitrified with additional glass-forming components so that iodine forms nanometer precipitates that are encapsulated in either a glass or a crystalline matrix. The loss of iodine, for example, during vitrification is minimal (˜0%). The preferred vitrification temperature is about 850-950° C. This temperature is lower than that generally used for glass formation (higher than about 1100° C.). The method of the invention does not require using silver for immobilizing iodine, thus reducing the cost of waste form development as well as the potential environmental hazards related to waste form production disposal. [0023] Fixation of nuclide-loaded getter materials, e.g., iodine-loaded mesoporous alumina, form the precursors of the glass-ceramic waste form of the invention. During the fixation process, one reduces the mobility of radioactive nuclides. For examples, one thereby induces: a) phase change—gas phase iodine which adsorbs onto mesoporous alumina is transferred to ionic phase (iodide, or iodate); b) part of the iodine being confined in the nanopores due to the encapsulation in nanopores, which is shown by the dramatic reduction of pore size and volume after the fixation (see FIGS. 9-12 ); c) reduction of solubility of the nuclide via changing the oxidative state, e.g., Rhenium (Re-VII) to Rhenium dioxide (Re-IV). Re is used as the surrogate of technetium in regular laboratory study (see resulting waste forms of FIGS. 7 and 8 ). The fixation can be accomplished via metal complexation, reaction with alkaline metal hydroxide/salts, either in the form of solids or solutions, for example, sodium, potassium hydroxide and their silicates. [0024] The invention is also of a method of making cost-effective nanostructured glass-ceramic as the waste form for deposition. The principle is to make the waste form both durable and low cost. To reach this goal, HTXRD (high temperature X-ray diffraction) is employed in parallel with leaching tests to optimize the vitrification condition for the most durable waste form. The combination result of HTXRD ( FIG. 4( a )) and leaching tests (Table 1) show the optimum vitrification temperature to be between about 800 to 900 degrees C. [0000] TABLE 1 Short summary of leaching tests Sample ID pH-end Iodine loss, % vitrification T, ° C. [SiO 2 ], ppm original composition phase First leaching test (LA) LA-1 9.29 14.5 1100 not analyzed m-Al—I + Na4SiO4 + “510” not analyzed LA-2 9.50 27.4 1100 not analyzed m-Al—Ag—I + Na4SiO4 + “510” not analyzed LA-3 8.18 38.5 1100 not analyzed m-Al—I + Na4SiO4 + “XF140-2” not analyzed LA-4 8.22 33.3 1100 not analyzed m-Al—Ag—I + Na4SiO4 + “XF140-2” not analyzed The following origin is m-Al—I/silver composite LB-1 8.40 37.4 1100 44 3225 + NC52-2(vit), amorphous to cristobalite LB-2 8.39 19.6 1100 44 CS749 + NC52-2(vit) amorphous to cristobalite LB-3 10.31 40.6 1100 717 m-Al—I + Na4SiO4 amorphous LB-4 10.66 29.6 1100 664 m-Al—I + Na4SiO4 amorphous to cristobalite LB-5 8.02 40.6 1100 m-Al—I + Na4SiO4 + SiO2 + B2O3 Quartz LB-6 8.28 15.9 1200 27 m-Al—I + Na4SiO4 + SiO2 Quartz & cristobalite The following original m-Al—I samples do not contain silver LC-1 10.30 5.8 750 750 C. m-Al—I + Na4SiO4 + “510” frit Quartz & cristobalite, Li 2 Si 2 O 5 LC2 10.12 1666 750 C. m-Al—I + Na4SiO4 + “510” frit LC-3 9.86 7.8 800 1034 800 C. m-Al—I + Na4SiO4 + “510” frit Quartz & cristobalite LC-4 9.89 1013 800 C. m-Al—I + Na4SiO4 + “510” frit LC-5 9.49 20.9 850 278 850 C. m-Al—I + Na4SiO4 + “510” frit Quartz & cristobalite LC-6 9.52 419 850 C. m-Al—I + Na4SiO4 + “510” frit LC-7 9.17 29.4 900 250 900 C. m-Al—I + Na4SiO4 + “510” frit Cristobalite LC-8 9.18 213 900 C. m-Al—I + Na4SiO4 + “510” frit The following original m-Al—I samples are fixed with potassium silicate LD-1 9.96 0.0 750 1444 750 C. m-Al—I + Na4SiO4 + “510” frit Quartz & cristobalite, Li 2 Si 2 O 5 LD-2 10.02 0.0 2145 750 C. m-Al—I + Na4SiO4 + “510” frit LD-3 9.74 0.0 800 987 800 C. m-Al—I + Na4SiO4 + “510” frit Quartz & cristobalite LD-4 9.52 0.0 497 800 C. m-Al—I + Na4SiO4 + “510” frit LD-5 9.20 0.0 850 206 850 C. m-Al—I + Na4SiO4 + “510” frit Quartz & cristobalite LD-6 9.15 0.0 174 850 C. m-Al—I + Na4SiO4 + “510” frit LD-7 8.68 13.5 900 279 900 C. m-Al—I + Na4SiO4 + “510” frit Cristobalite LD-8 8.94 7.6 279 900 C. m-Al—I + Na4SiO4 + “510” frit [0025] The preferred method to make a nanostructured glass-ceramic waste form according to the invention is described as follows: [0026] Loading iodine on mesoporous alumina/composite. Mesoporous alumina is weighed into a Teflon jar, along with a vial which contains iodine weighed at the ratio of, preferably, about 1:10 (I/mesoporous alumina). The Teflon jar is screw-capped and set in the oven at about 90° C. for 6 hours. Then, the jar is opened in a hood and let cool to the room temperature. [0027] Fixation of iodine loaded on alumina/composite. At about room temperature, about 3 g of iodine-loaded mesoporous alumina is ground-mixed with about 27 g of sodium silicate solution. The mixture is gradually dried at an increasing temperature from the room temperature to about 120° C. This dried mixture is referred to herein as the ‘glass precursor’. The glass precursor is then ground and mixed with frits (e.g., Ferro Co. according to Table 1) or other glass forming components (e.g., silica (SiO 2 )). [0028] Vitrification: The mixture is heated in air to a selected temperature between about 750 and 1100° C. depending on the composition and test conditions. [0029] Leaching test: The resulting glass-ceramic waste form is ground and sieved to about 250 μm (>90%). About 0.8 to 1 gram of the ground material is set in about a 50-mL buffer solution in a screw-capped plastic container, which is kept in a Teflon jar with about 20 mL of DI water. The screw-capped Teflon jar is set in the oven for about 7 days at about 90° C. At the conclusion of each leaching test, the liquid suspension is filtered with filter paper. The filtrate is saved for further analyses. The residual leached glass is dried overnight and then subjected to EDXRF analysis for iodine concentrations. These concentrations are then compared with the glass prior to the leaching test to determine the percentage of iodine loss from waste form during leaching. The filtrate is analyzed for its pH and silica concentration. [0030] Iodine loading on mesoporous alumina composites. Iodine loadings of the waste forms are given in Table 2. The adsorption capacity of the getter materials is shown in FIG. 1 and Table 3. Data in FIG. 1 were obtained from exhaustion experiments, in which the iodine-loaded material was heated overnight at about 90° C. and cooled to about room temperature in an open jar. The data tabulated in Table 3 are obtained from the sorption experiments without subsequent overnight desorption at about 90° C. Note in Table 3 that monolithic mesoporous alumina (NC71) with no silver included exhibits higher iodine sorption capability than the material with silver, indicating that silver may not be necessary for iodine sorption. [0000] TABLE 2 Iodine loadings on glass-ceramic materials [I], normalized [I] in the to per g of vitrification Iodine loss ceramic- mesoporous temperature, % during Glass sample glass, ppm alumina, ppm ° C. vitrification* NC48-1 + 429 7064 1100 32 “510” NC48-2 + 915 15067 1100 0 “510” NC48-1 + 698 11494 1100 0 “XF140-2” NC48-2 + 1069 17603 1100 0 “XF140-2” NC52-2 + 617 9872 1100 5 “3225” NC52-2 + 570 9120 1100 12 “CS749” NC67-7 748 11968 1200 0 NC67-6 243 3880 1100 63 iso-750 855 13680 750 0 ios-800 649 10384 800 0 iso-850 659 10544 850 0 iso-900 706 11296 900 0 *Non-zero numbers are due to the heterogeneity of samples. [0000] TABLE 3 Iodine adsorption on mesoporous alumina/mesoporous aluminum-silver composites I/(m-Al) [I] on mesoporous alumina, Sample ID ratio Sample wt, g ppm NC72 (w/silver) 0.114 0.2036 35674 NC71 (monolith) 0.107 0.2035 66245 BET data of these two materials Surface Average area, Pore vol. pore size, Micropore vol. Sample ID m 2 /g cm 3 /g nm cm 3 /g NC72 (w/silver) 215 0.706 12.7 0.006644 NC71 (monolith) 354 1.75 19.15 0.014549 [0031] Fixation of Iodine with Sodium Silicate. During the fixation the form of the iodine in the mesoporous alumina is changed from gas to ionic species, as indicated by FTIR spectra ( FIG. 2 ). In FIG. 2 , NaOH-12 stands for iodine which has reacted with sodium hydroxide solution. NC52-2 is the product of mesoporous aluminum-silver composite fixed with sodium silicate (the glass precursor). NC52-3 is an iodine loaded mesoporous aluminum-silver composite reacted with sodium hydroxide solution, with no silica involved. The spectrum labeled as Ag—Al—I stands for iodine-loaded mesoporous aluminum-silver composite (before fixation by sodium silicate). Finally, the spectrum labeled as Na 4 SiO 4 is sodium silicate. All the compounds or materials analyzed are dried solids. The iodine in sample NaOH—I 2 is expected to consist of iodide [I(−1)) and iodate (I(+5)) forms due to the following reaction: [0000] 3I 2 +3H 2 O→5I − +IO 3 − +6H + [0032] Although no detailed peak analysis has been performed, it is obvious that the spectra of NaOH—I 2 and NC52-3 have overlaps around wavenumbers of 1440 and 790 cm −1 , whereas, the spectrum of sample Ag—Al—I does not show any specific peak at these positions. Therefore, the iodine form in initial mesoporous material is different from that in the fixed materials. Because of this change of iodine into less volatile forms, the iodine loss during vitrification is minimal (˜0%). [0033] Leaching test. The final leachate solutions were subjected to silica concentration analysis (HACH silica method DR/2400 (8185) for high concentration of 1.0 to 100.0 mg/L). The dissolved silica concentrations, pH, and the loss of iodine during leaching are shown in Table 1. Among the glass frits tested and other formulations tried, the Frit 510 mixture resulted in the least iodine loss during leaching tests. Frit 510 comprises 0-2% Al 2 O 3 , 12-15% B 2 O 3 , 7-9% Li 2 O, 7-9% Na 2 O, and 68-72% SiO 2 . Therefore, a preferred frit composition for encapsulation of iodine is recommended to be similar to that of Frit 510. The vitrification temperature can also affect waste form performance. The study shows that lower iodine loss due to leaching is observed for the waste form vitrified at lower temperatures in the range of about 750 to 900° C. [0034] Microstructure analyses of glass-ceramic waste forms. A vitrification study using Ferro frit “510” and iodine-loaded mesoporous alumina was conducted. The vitrification was carried out at temperatures of about 750, 800, 850, and 900° C. for minutes, respectively. The resulting materials were characterized with XRD (including HTXRD) and TEM. FIGS. 3( a )- 3 ( d ) show the morphology of the ceramic/glass mixtures. The increasing surface exposure in terms of the void space due to bubbling during vitrification matches the durability decreasing with increase in temperature. The XRD patterns are shown in FIG. 4( a ), which indicates the formation of Li 2 Si 2 O 5 mineral phase along with quartz, and cristobalite phase at 750° C. Further heating results in loss of Li 2 Si 2 O 5 and slow disappearance of quartz and cristobalite phases. [0035] Highly efficient mesoporous alumina and its composites are preferred as the getter materials (adsorbents) to sequestrate highly mobile radionuclides including 129 I. Again, the present invention is of a method to convert these getter materials into durable waste forms at relatively lower vitrification temperatures (and of the resulting waste forms). The resulting waste forms are glass-ceramic nanocomposite that can immobilize a wide range of radionuclides with high loading capacity. [0036] Ferro frit “510” with iodine-loaded mesoporous alumina is preferred for the formation of glass-ceramic waste forms based on the batch leaching tests, which indicated that this embodiment results in the least iodine loss during leaching tests. Note that just for screening purpose (to accelerate the experiments) the leaching method used here involves rather aggressive physical and chemical conditions. Unlike the conventional method for glass durability test (using slab or cubic glass), the waste form was ground to the size of 250 μm (high exposed surface area) and a weak alkaline buffer solution (pH 8.5) was employed. For comparison, approximately the same temperature, duration, chemistry of initial solution, and size of the target materials were used for all leaching tests. [0037] The leaching rate of the waste form depends on the stability of both radionuclide-bearing nanocrytallites and their surround matrix. As shown in FIGS. 5( a )- 5 ( c ), iodine-bearing nanocrystals are embedded in an amorphous matrix. This is consistent with XRD analyses ( FIGS. 4( a ) and 6 ), which indicate that at a relatively low sintering temperature, e.g., between 750-800° C., several crystalline phases appear. The leaching test result indicates that glass-ceramic waste forms vitrified at 750° C. seem to have the lowest iodine loss during leaching. This may be due to the high content of crystalline quartz (possibly as the embedding matrix) as well as the presence of crystalline lithium silicate. Actually, in the case that the glass ceramic sample containing Ag, nanocrystals of Agl are observed to be embedded in crystalline quartz. At a higher vitrification temperature, iodine anions are expected to distribute more uniformly in the resulting waste form, probably “dissolved” in glass matrix, [0038] High silica leaching rate for the lower temperature waste forms is directly related to the resulting solution pH. In these waste forms, Na is not completely incorporated into Al—Si—O frameworks. The preferential release of Na gives rise to the high solution pH. [0039] For waste species other than iodine, such as technetium, it is anticipated that during the fixation process of the invention an oxyanionic species such as TcO 4 − may also change its oxidative status to a less soluble reduced form, e.g., from Tc(VII)O 4 − to Tc(IV)O 2 . [0040] Nanopore structures in an adsorbent play important role in radionuclide sequestration and encapsulation. As shown in Table 4, the presence of nanopores in the initial adsorbent material reduces iodine losses in subsequent fixation and vitrification processes. [0000] TABLE 4 Enhancement of iodine retention by nanopore structures % of lost % of lost during Material I sorption (ppm) during fixation vitrification Regular alumina 98 Not tested Not tested Activated alumina 8700 45 65 Nanoporous 25000 ~0 ~0 alumina [0041] To conclude, the present invention is of a method for the formation of nanostructured glass-ceramic waste forms that can be used for disposition of various radionuclides, especially iodine. This method is based on use of, preferably, mesoporous alumina and its derivatives as getter materials for entrapping gaseous iodine. In this method, iodine sorbed on mesoporous material is first reacted with sodium silicate to convert molecular iodine into less volatile ionic species. The resulting material is then vitrified with additional glass-forming components so that iodine forms nanometer precipitates that are encapsulated in either a glass or a crystalline matrix. The loss of iodine during vitrification is minimal (˜0%). The preferred vitrification temperature range (850-950° C.) has been determined for the least iodine loss during a waste form leaching test. This temperature is lower than that generally used for glass formation. Specifically, the method reported here does not require using silver for immobilizing iodine, thus reducing the cost of waste form development. [0042] Note that in the specification and claims, “about” or “approximately” means within ten percent (10%) of the numerical amount cited. [0043] Although the invention has been described in detail with particular reference to these preferred embodiments, other embodiments can achieve the same results. Variations and modifications of the present invention will be obvious to those skilled in the art and it is intended to cover in the appended claims all such modifications and equivalents. The entire disclosures of all references, applications, patents, and publications cited above are hereby incorporated by reference.

1a

This application is a continuation-in-part of application Ser. No. 09/137,056, filed on Aug. 20, 1998, now U.S. Pat. No. 6,017,849. FIELD OF THE INVENTION The present invention generally relates to the regulation of plant physiology, in particular to methods for inhibiting the ethylene response in plants or plant products, in order to prolong their shelf life. The invention relates to prolonging the shelf life of cut flowers and ornamentals, potted plants (edible and non-edible), transplants, and plant foods including fruits, vegetables and root crops. The present invention has three embodiments. The first embodiment relates to methods of minimizing impurities capable of reversibly binding to plant ethylene receptor sites during the synthesis of cyclopropene and its derivatives, in particular methylcyclopropene. Certain impurities produced during the manufacture of cyclopropene and its derivatives, in particular methylcyclopropene, have negative effects on treated plants. Therefore, when plants are treated with cyclopropene and its derivatives, in particular methylcyclopropene, made by using the methods of synthesis of the present invention, the negative effects of these impurities are avoided. The second embodiment of the present invention relates to complexes formed from molecular encapsulation agents, such as cyclodextrin, and cyclopropene or its derivatives, such as methylcyclopropene, in addition to complexes formed from molecular encapsulation agents and cyclopentadiene or diazocyclopentadiene or their derivatives. These molecular encapsulation agent complexes provide a convenient and safe means for storing and transporting the compounds capable of inhibiting the ethylene response in plants. These molecular encapsulation agent complexes are important because the compounds capable of inhibiting the ethylene response in plants are reactive gases and therefore highly unstable because of oxidation and other potential reactions. The third embodiment relates to convenient methods of delivering to plants the compounds capable of inhibiting their ethylene responses in order to extend shelf life. These methods involve contacting the molecular encapsulation agent complex with a solvent capable of dissolving the molecular encapsulation agent, thereby liberating the compound capable of inhibiting the ethylene response so it can contact the plant. BACKGROUND OF THE INVENTION The present invention generally relates to the regulation of plant growth and to methods of inhibiting ethylene responses in plants by application of cyclopropene, cyclopentadiene, diazocyclopentadiene or their derivatives, in particular methylcyclopropene. The present invention specifically relates to methods of synthesis and molecular encapsulation agent complexes, in addition to storage, transport and application of these gases that inhibit ethylene responses in plants. Plant growth responses are affected by both internal and external factors. Internal control of plant processes are under the influence of genetic expression of the biological clocks of the plant. These processes influence both the extent and timing of growth processes. Such responses are mediated by signals of various types which are transmitted within and between cells. Intracellular communication in plants typically occurs via hormones (or chemical messengers) as well as other less understood processes. Because communications in a plant are typically mediated by plant hormones, both the presence and levels of such hormones are important to specific plant cell reactions. The plant hormone that is most relevant to the present invention is ethylene, which has the capacity to affect many important aspects of plant growth, development and senescence. The most important effects of ethylene include processes normally associated with senescence, particularly fruit ripening, flower fading and leaf abscission. It is well known that ethylene can cause the premature death of plants including flowers, leaves, fruits and vegetables. It can also promote leaf yellowing and stunted growth as well as premature fruit, flower and leaf drop. Because of these ethylene-induced problems, very active and intense research presently concerns the investigation of ways to prevent or reduce the deleterious effects of ethylene on plants. One major type of treatment used to mitigate the effects of ethylene employs ethylene synthesis inhibitors. These ethylene synthesis inhibitors reduce the quantity of ethylene that a plant can produce. Specifically, these ethylene synthesis inhibitors inhibit pyridoxal phosphate-mediated reactions and thereby prevent the transformation of S-adenosynimethione to 1-amino cyclopropane-1-carboxylic acid, the precursor to ethylene. Staby et al. (“Efficacies of Commercial Anti-ethylene Products for Fresh Cut Flowers”, Hort Technology, pp. 199-202, 1993) discuss the limitations of these ethylene synthesis inhibitors. Because ethylene synthesis inhibitors only inhibit a treated plant's production of ethylene, they do not suppress the negative effects of ethylene from environmental sources. These environment sources of ethylene exist because ethylene is also produced by other crops, truck exhaust, ethylene gashing units and other sources, all of which can affect a plant during production, shipment, distribution and end use. Because of this, ethylene synthesis inhibitors are less effective than products that thwart a plant's ethylene responses. For a discussion of the ethylene response in plants, see U.S. Pat. No. 3,879,188. The other major type of treatment used to mitigate the effects of ethylene employs blocking the receptor site that signals ethylene action. One of the best known compounds for inhibiting the ethylene response in plants, as well as preventing the deleterious effects from environmental sources of ethylene, is silver thiosulfate (“STS”). An example of a commercial STS product is SILFLOR solution, available from Floralife, Inc., Burr Ridge, Ill. STS is very effective in inhibiting the ethylene response in plants and has been used because it moves easily in the plant and is not toxic to plants in its effective concentration range. STS can be used by growers, retailers and wholesalers as a liquid that is absorbed into the stems of the flowers. While STS is highly effective, it has a serious waste disposal problem. It is illegal to dispose of the silver component of STS by conventional means, such as by using a laboratory sink, without first pretreating the STS to remove the silver. It is also illegal to spray STS on potted plants. Consequently because of this disposal problem which is typically ignored by growers, STS is now almost exclusively utilized only by growers. Therefore, there is a great desire among postharvest physiologists to find alternatives to STS. To the knowledge of the present inventors, the only commercially acceptable replacements for STS are cyclopropene, cyclopentadiene, diazocyclopentadiene and their derivatives. Many compounds such as carbon dioxide which block the action of ethylene diffuse from the ethylene receptor or binding site over a period of a few hours. Sisler & Wood, Plant Growth Reg. 7, 181-191, 1988. While these compounds may be used to inhibit the action of ethylene, their effect is reversible and therefore they must be exposed to the plant in a continuous manner if the ethylene inhibition effect is to last for more than a few hours. Therefore, an effective agent for inhibiting the ethylene response in plants should provide an irreversible blocking of the ethylene binding sites and thereby allow treatments to be of short duration. An example of an irreversible ethylene inhibiting agent is disclosed in U.S. Pat. No. 5,100,462. However, the diazocyclopentadiene described in that patent is unstable and has a strong odor. Sisler et al., Plant Growth Reg. 9, 157-164, 1990, showed in a preliminary study that cyclopentadiene was an effective blocking agent for ethylene binding. However, the cyclopentadiene described in that reference is also unstable and has a strong odor. U.S. Pat. No. 5,518,988 discloses the use of cyclopropene and its derivatives, including methylcyclopropene, as effective blocking agents for ethylene binding. Although the compounds in this patent do not suffer from the odor problems of diazocyclopentadiene and cyclopentadiene, because they contain a carbene group, they are relatively unstable due to their potential for undergoing oxidation and other reactions. Therefore, a problem of stability of these gases, as well as the explosive hazards these gases present when compressed, exist. To solve these problems, the present inventors have developed a method of incorporating these gaseous compounds, which inhibit the ethylene response in plants, in a molecular encapsulation agent complex in order to stabilize their reactivity and thereby provide a convenient and safe means of storing, transporting and applying or delivering the active compounds to plants. The application or delivery methods of these active compounds can be accomplished by simply adding water to the molecular encapsulation agent complex. In trying to implement the teaching of U.S. Pat. No. 5,518,988, the problems associated with the stability of the gases and the potential explosive hazard of using compressed gases limit their use and therefore their effectiveness. To solve those problems, the present inventors developed a molecular encapsulation agent complex that stabilizes the reactivity of these gases and thereby provides a convenient and safe means of storing, transporting and applying or delivering these gases to plants. This approach is an important advance over the art as it allows for the convenient and safe storage, transport and use of gases that are otherwise difficult to store, ship and dispense. The present invention will now allow for the safe, convenient and consistent use of these gases in the field by the grower, in addition to their use in distribution and in the retail marketplace. In fact, a complex of methylcyclopropene and the molecular encapsulating agent cycloclextrin allows for a product having a shelf life of greater than one year. Another feature of the molecular encapsulation agents of the present invention is that once they trap the gaseous active agent in the complex, the complex (and hence the gaseous active agent) does not exhibit a very high vapor pressure and is therefore protected from oxidation and other chemical degradation reactions. A gaseous active compound such as cyclopropene or derivatives thereof is held in a caged molecule whereby the vapor pressure of the solid is very low due to the weak atomic forces (van de Waals and hydrogen binding). The binding of these gaseous active compounds with these molecular encapsulation agents holds the active compound until ready for use. The present invention also prolongs the life of plants by providing an effective and proper dose of the encapsulated active compound capable of inhibiting the ethylene response, which is subsequently desorbed into a gas form for administration to the plant. The invention further embodies the release of the desired active compound from the complex by dissolving the complex in a suitable solvent in order to release the gaseous active compound, thereby serving as an improved gaseous plant treatment. A major advantage of the present invention is that it provides an effective, user-friendly product for non-technical customers, florists and wholesalers. In addition, the molecular encapsulation agent complex acts as a controlled release agent for treatment with such active gaseous compounds as cyclopropene and methylcyclopropene. As a result, the present invention promotes less human exposure to the target compound than other means of application. Additionally, the user has more control over the application of the gaseous active compound because the active gaseous compound is slowly released from the complex in the presence of a suitable solvent. Another advantage of the present invention is the amount of selective inclusion of the gaseous active compounds such as cyclopropene and methylcyclopropene into the molecular encapsulation agent. Using the teachings of the present invention, significant quantities of methylcyclopropene and other active compounds can now be encapsulated into a molecular encapsulation agent such as cyclodextrin, far exceeding the normal expected amount usually found with other solids. A still further advantage of the present invention over the use of compressed concentrated gases is the elimination of the need for gas tanks, regulators, and OSHA compliance for pressurized gas tanks. This results in a substantial cost savings for the manufacturer as well as the customer. In addition, it eliminates the explosive and flammable potential associated with the use of gas tanks holding a highly reactive organic molecule. Moreover, the present invention eliminates the self polymerization and decomposition of gases that occur with compressed gases or liquids containing them. Another advantage of the present invention over other inert solid carrier systems proposed for use in applying cyclopropene, such as dust, talc, silica and flour, is that it provides a product containing the active gaseous compound with increased stability. For example, the molecular encapsulation agent cyclodextrin protects the active cyclopropene or methylcyclopropene molecule from external conditions, such as ultraviolet degradation, which are problematic in photosensitive compounds such as these. A still further advantage of the present invention is that the molecular encapsulation agent complex results in more effective use of the active gaseous compound. For example, a reduced quantity of cyclopropene can be utilized to obtain an effective treatment compared with the use of prior proposed cyclopropene solid carriers or compressed gases. This results in less waste and less packaging needed for the commercial product. In another embodiment, this invention relates to the synthesis of cyclopropene and its derivatives including methylcyclopropene by methods that lower the incidence of impurities, such as hazardous reaction products and by-products, that interfere with the ethylene binding effectiveness of cyclopropene and its derivatives. These reaction product impurities include compounds that bind tightly but reversibly to the ethylene receptor site and inhibit the irreversible binding of cyclopropene and its derivatives, especially methylcyclopropene. The synthesis of these cyclopropene and derivative compounds is important because if irreversible binding to the receptor site does not take place during plant treatment, the plant will not be protected against the effects of ethylene. The prior art syntheses of methylcyclopropene has created problems when the methylcyclopropene was used for inhibiting the ethylene response in plants. While it is well documented in U.S. Pat. No. 5,518,988 that methylcyclopropene and other similar compounds are active against ethylene, it has been discovered that not all methods of synthesis are as effective or preferable as the presently claimed synthesis method. First, it is necessary to avoid producing during synthesis products (or impurities) that reversibly bind to the same ethylene receptor site as the intended active compound. Because these impurities do not irreversibly bind in a manner consistent with the inactivation of the receptor site without phytotoxicity, the effectiveness of using such a reaction product mixture without further processing is reduced. The specific impurities that must be avoided in the synthesis in order to obtain optimal performance of the reaction mixture include methylenecyclopropane, methylcyclopropanes and butanes. The present inventors have discovered that of all the Lewis bases used for the production of methylcyclopropene, sodium amide and lithium diisopropylamide are most preferred. Synthesis using various metal hydrides and hydroxides were found to produce high levels of other reaction products that lowered the performance of the methylcyclopropene for plant uses. For example, using butynes, 3-hydroxy-2-methylpropenes and other similar starting materials generally yields an impure reaction product that is not appropriate for use in the treatment of plants. Additional features and advantages of the present invention are described in, and will be apparent from, the detailed description and examples provided. SUMMARY OF THE INVENTION In a method of minimizing impurities embodiment, the present invention relates to a method of minimizing impurities capable of reversibly binding to plant ethylene receptor sites comprising the steps of reacting, in an inert environment, a metal amide salt and a halogenated carbene, optionally in the presence of a non-reactive solvent, to form a compound having the following structure wherein n is a number from 1 to 10 and R is selected from the group consisting of hydrogen, saturated or unsaturated C1 to C10 alkyl, hydroxy, halogen, C1 to C10 alkoxy, amino and carboxy. This method of minimizing impurities embodiment is generically referred to as the cyclopropene method of minimizing impurities. The preferred metal amide salts for use in this method of minimizing impurities embodiment are sodium amide, lithium amide, potassium amide, lithium diisopropylamide and sodium diisopropylamide. The preferred halogenated carbenes for use in this method of minimizing impurities embodiment are 3-chloro-3-methyl-2-methylpropene, 3-bromo-3-methyl-2-methylpropene, 3-chloro-2-methylpropene and 3-bromo-2-methylpropene. In a more specific method of minimizing impurities embodiment, the present invention relates to a method of minimizing impurities capable of reversibly binding to plant ethylene receptor sites comprising the steps of reacting, in an inert environment, a metal amide salt and a halogenated methyl propene, optionally in the presence of a non-reactive solvent, to form methylcyclopropene. This more specific method of minimizing impurities embodiment is referred to as the methylcyclopropene method of minimizing impurities. The preferred metal amide salts for use in this more specific method of minimizing impurities embodiment are sodium amide, lithium amide, potassium amide, lithium diisopropylamide and sodium diisopropylamide. The preferred halogenated methyl propenes for use in this more specific method of minimizing impurities embodiment are 3-chloro-2-methylpropene and 3-bromo-2-methylpropene. In one of the molecular encapsulation agent complex embodiments, which is generically referred to as the cyclopropene molecular encapsulation agent complex, the complex is formed from a molecular encapsulation agent and a compound having the following structure wherein n is a number from 1 to 10 and R is selected from the group consisting of hydrogen, saturated or unsaturated C1 to C10 alkyl, hydroxy, halogen, C1 to C10 alkoxy, amino and carboxy. The preferred molecular encapsulation agents for use in this cyclopropene molecular encapsulation agent complex embodiment include a cyclodextrin, a crown ether, a polyoxyalkylene, a prophorine, a polysiloxane, a phopnazene and a zeolite. Cyclodextrin and in particular alpha-cyclodextrin are particularly preferred. The preferred compounds capable of inhibiting the ethylene response in plants for use in this cyclopropene molecular encapsulation agent complex embodiment are cyclopropene and dimethylcyclopropene. In a more specific molecular encapsulation agent complex embodiment, which is referred to as the methylcyclopropene molecular encapsulation agent complex, the complex is formed from a nolecular encapsulation agent and methylcyclopropene. The preferred molecular encapsulation agents for use in this methylcyclopropene molecular encapsulation agent complex embodiment include a cyclodextrin, a crown ether, a polyoxyalkylene, a prophorine, a polysiloxane, a phophazene and a zeolite. Cyclodextrin and in particular alpha-cyclodextrin are particularly preferred. In another molecular encapsulation agent complex embodiment, which is generically referred to as the cyclopentadiene molecular encapsulation agent complex, the complex is formed from a molecular encapsulation agent and a compound having the following structure wherein n is a number from 1 to 10 and R is selected from the group consisting of hydrogen, saturated or unsaturated C1 to C10 alkyl, hydroxy, halogen, C1 to C10 alkoxy, amino and carboxy. The preferred molecular encapsulation agents for use in this cyclopentadiene molecular encapsulation agent complex embodiment include a cyclodextrin, a crown ether, a polyoxyalkylene, a prophorine, a polysiloxane, a phophazene and a zeolite. Cyclodextrin and in particular alpha-cyclodextrin are particularly preferred. In still another molecular encapsulation agent complex embodiment, which is generically referred to as the diazocyclopentadiene molecular encapsulation agent complex, the complex is formed from a molecular encapsulation agent and a compound having the following structure wherein n is a number from 1 to 10 and R is selected from the group consisting of hydrogen, saturated or unsaturated C1 to C10 alkyl, hydroxy, halogen, C1 to C10 alkoxy, amino and carboxy. The preferred molecular encapsulation agents for use in this diazocyclopentadiene molecular encapsulation agent complex embodiment include a cyclodextrin, a crown ether, a polyoxyalkylene, a prophorine, a polysiloxane, a phophazene and a zeolite. Cyclodextrin and in particular alpha-cyclodextrin are particularly preferred. In one of the method of delivery of a compound to a plant to inhibit an ethylene response in the plant embodiments, which is generically referred to as the cyclopropene method of delivery, the method comprises the step of contacting a complex formed from a molecular encapsulation agent and a compound having the following structure wherein n is a number from 1 to 10 and R is selected from the group consisting of hydrogen, saturated or unsaturated C1 to C10 alkyl, hydroxy, halogen, C1 to C10 alkoxy, amino and carboxy, with a solvent capable of dissolving the molecular encapsulation agent, and thereby liberating the compound from the molecular encapsulation agent so that it can contact the plant. The preferred molecular encapsulation agents for use in this cyclopropene method of delivery embodiment include a cyclodextrin, a crown ether, a polyoxyalkylene, a prophorine, a polysiloxane, a phophazene and a zeolite. Cyclodextrin and in particular alpha-cyclodextrin are particularly preferred. The preferred compounds capable of inhibiting the ethylene response in plants for use in this cyclopropene method of delivery embodiment are cyclopropene and dimethylcyclopropene. The preferred solvent for use in this cyclopropene method of delivery embodiment is water, and the water may additionally comprise an acidic or alkaline agent. A more specific feature of this cyclopropene method of delivery embodiment comprises bubbling a gas through the solvent while it is in contact with the complex. In addition, another specific feature of this cyclopropene method of delivery embodiment comprises applying heat to the solvent either before it contacts the complex or during that contact. In a more specific method of delivery embodiment, which is specifically referred to as the methylcyclopropene method of delivery, the method comprises the step of contacting a complex formed between a molecular encapsulation agent and methylcyclopropene with a solvent capable of dissolving the molecular encapsulation agent, and thereby liberating the methylcyclopropene from the molecular encapsulation agent so that it can contact the plant. The preferred molecular encapsulation agents for use in this methylcyclopropene method of delivery embodiment include a cyclodextrin, a crown ether, a polyoxyalkylene, a prophorine, a polysiloxane, a phophazene and a zeolite. Cyclodextrin and in particular alpha-cyclodextrin are particularly preferred. The preferred solvent for use in this methylcyclopropene method of delivery embodiment is water, and the water may additionally comprise an acidic or alkaline agent. For example, a buffering solution that can be used to facilitate the release of the methylcyclopropene gas contains 0.75% potassium hydroxide and 0.75% sodium hydroxide after the proper amount of water is added. A more specific feature of this methylcyclopropene method of delivery embodiment comprises bubbling a gas through the solvent while it is in contact with the complex. In addition, another specific feature of this methylcyclopropene method of delivery embodiment comprises applying heat to the solvent either before it contacts the complex or during that contact. In another method of delivery embodiment, which is generically referred to as the cyclopentadiene method of delivery, the method comprises the step of contacting a complex formed from a molecular encapsulation agent and a compound having the following structure wherein n is a number from 1 to 10 and R is selected from the group consisting of hydrogen, saturated or unsaturated C1 to C10 alkyl, hydroxy, halogen, C1 to C10 alkoxy, amino and carboxy, with a solvent capable of dissolving the molecular encapsulation agent, and thereby liberating the compound from the molecular encapsulation agent so that it can contact the plant. The preferred molecular encapsulation agents for use in this cyclopentadiene method of delivery embodiment include a cyclodextrin, a crown ether, a polyoxyalkylene, a prophorine, a polysiloxane, a phophazene and a zeolite. Cyclodextrin and in particular alpha-cyclodextrin are particularly preferred. The preferred solvent for use in this cyclopentadiene method of delivery embodiment is water, and the water may additionally comprise an acidic or alkaline agent. A more specific feature of this cyclopentadiene method of delivery embodiment comprises bubbling a gas through the solvent while it is in contact with the complex. In addition, another specific feature of this cyclopentadiene method of delivery embodiment comprises applying heat to the solvent either before it contacts the complex or during that contact. In still another method of delivery embodiment, which is generically referred to as the diazocyclopentadiene method of delivery, the method comprises the step of contacting a complex formed from a molecular encapsulation agent and a compound having the following structure wherein n is a number from 1 to 10 and R is selected from the group consisting of hydrogen, saturated or unsaturated C1 to C10 alkyl, hydroxy, halogen, C1 to C10 alkoxy, amino and carboxy, with a solvent capable of dissolving the molecular encapsulation agent, and thereby liberating the compound from the molecular encapsulation agent so that it can contact the plant. The preferred molecular encapsulation agents for use in this diazocyclopentadiene method of delivery embodiment include a cyclodextrin, a crown ether, a polyoxyalkylene, a prophorine, a polysiloxane, a phophazene and a zeolite. Cyclodextrin and in particular alpha-cyclodextrin are particularly preferred. The preferred solvent for use in this diazocyclopentadiene method of delivery embodiment is water, and the water may additionally comprise an acidic or alkaline agent. A more specific feature of this diazocyclopentadiene method of delivery embodiment comprises bubbling a gas through the solvent while it is in contact with the complex. In addition, another specific feature of this diazocyclopentadiene method of delivery embodiment comprises applying heat to the solvent either before it contacts the complex or during that contact. DETAILED DESCRIPTION OF THE INVENTION The Compounds that Inhibit Plant Ethylene Responses The compounds that inhibit ethylene responses in plants are disclosed in the following references, all of which are incorporated by reference. U.S. Pat. No. 5,100,462 discloses that diazocyclopentadiene and its derivatives are effective blocking agents that inhibit the ethylene response in plants. Sisler et al., Plant Growth Reg. 9, 157-164, 1990, discloses that cyclopentadiene was an effective blocking agent for inhibiting the ethylene response in plants. U.S. Pat. No. 5,518,988 discloses that cyclopropene and its derivatives, including methylcyclopropene, are effective blocking agents for inhibiting the ethylene response in plants. Rather than repeat the disclosure of those references in this specification, they are incorporated by reference in their entireties. The derivatives of cyclopropene, cyclopentadiene and diazocyclopentadiene may contain from 1 to 4 R groups. The number of such R groups is more preferably 2 and most preferably 1. As previously mentioned, suitable R groups include hydrogen, saturated or unsaturated C1 to C10 alkyl, hydroxy, halogen, C1 to C10 alkoxy, amino and carboxy. The term “alkyl” is defined herein to refer to linear or branched, saturated or unsaturated alkyl groups. Examples include but are not limited to methyl, ethyl, propyl, isopropyl and butyl. Alkyl groups of the present invention are most preferably single carbon or linear. The Synthesis of the Cyclopropene and Methylcyclopropene Embodiments Pursuant to the present invention, cyclopropene and its derivatives are made by reacting, in an inert environment, a metal amide salt, such as lithium amide salt, sodium amide salt, potassium amide salt, lithium diisopropylamide salt, sodium diisopropylamide salt or other metal amide salts, and a halogenated carbene, such as 3-chloro-3-methyl-2-methylpropene, 3-bromo-3-methyl-2-methylpropene, 3-chloro-2-methylpropene, 3-bromo-2-methylpropene or some other halogenated carbene. The specific compounds named above are preferred. Methylcyclopropene is made under the same conditions with the same metal amide salts discussed above by reacting them with a halogenated methylpropene. The preferred halogenated methyl propenes are 3-chloro-2-methylpropene and 3-bomo-2-methylpropene. These halogenated methyl propenes lead to a high purity product for the intended use and are readily available. Suitable methods for making cyclopropene and its derivatives, including methylcyclopropene, are covered in the examples below. While a variety of different volatile and non-volatile non-reactive solvents can be utilized, preferred suitable solvents include glycerine, mineral oil, polyethylene glycol, diglyme and tetraglyme. The use of a non-reactive solvent is optional. The inert environment can be created by any known method including purging the reaction vessel with nitrogen or any other inert gas. The concentration ratio of the metal amide salt to the halogenated carbene or halogenated methyl propene is a molar ratio of about 1:1 to about 4:1. The reaction temperature can range from about 20° to about 60° C. and the reaction pressure can range from about 1 to about 100 psi. The resulting exothermic solution from this reaction is allowed to react until no further heat is given off. After the reaction is complete, a polar solvent is added to the reaction solution. While a variety of polar solvents can be used, suitable examples of such polar solvents include water, acetone and alcohol. After the polar solvent has been added, the head space of the reaction solution is displaced, cooled and placed into a second vessel containing a molecular encapsulation agent, such as cyclodextrin, and buffered water to form the desired molecular encapsulation agent complex. When the gas is released into the original vessel using sodium amide, a non-polar solvent is used to release the gas when a lithium salt is employed as the metal amide salt. Although it is not necessary to achieve the objectives of this invention, fractional distillation can be used on the final product. In one preferred embodiment, the headspace of the reaction solution is cooled through a condenser and cold trap. The water used with the molecular encapsulation agent is buffered to approximately a pH of 4 to 6, and the reaction product and molecular encapsulation agent is stirred for 1 to 24 hours at temperatures ranging from room temperature to 40° C. After the complex is formed, the excess water is filtered off and the resulting slurry dried to form a powder. The examples below describe a method of preparing a molecular encapsulation agent from methylcyclopropene and alpha-cyclodextrin. The Molecular Encapsulation Agent Complex As previously explained, forming a complex from the molecular encapsulation agent and the gaseous compound capable of inhibiting the ethylene response in plants is important for two reasons. First, strained carbenes such as methylcyclopropene are quite unstable to reaction with oxygen, self polymerization and reaction with other organic compounds. The complexes of the present invention overcome those instability problems. Second, it is preferable to use a product that has a long shelf life, is simple to handle and comparatively non-reactive. The complexes of the present invention meet those objectives as well. Methylcyclopropene is reactive and explosive at concentrations over one percent. Additionally, it is difficult to handle as a gas, requires compression into metal containers or the use of a non-oxygen permeable container. Since for most applications, less than 1 ppm (part per million) and preferably less than 1 ppb (parts per billion) of methyloyclopropene in the atmosphere are required, the amount of methylcyclopropene required to treat a normal room is about one gram or less. The recommended dosage is around 500-700 ppb for 4-6 hours at room temperature for a few crops. A molecular encapsulation agent is a compound that has a lock and key structure similar to an enzyme whereby a substrate selectively fits into the encapsulation site. The most preferred molecular encapsulation agent found to date is alpha-cyclodextrin. Other molecular encapsulation agents, such as crown ethers, polyoxyalkylenes, prophorines, polysiloxanes, phophazenes and zeolites, were also found to work. Most of these molecular encapsulation agents can be obtained from the Aldrich Chemical Company. Methylcyclopropene can be complexed with cyclodextrin in water. For example, when the water is removed after methylcyclopropene is bubbled through an aqueous solution of alpha-cyclodextrin, it was discovered that the methylcyclopropene was firmly locked into the cyclodextrin cage structure. In addition, the cyclodextrin cake after drying can be milled into a powder and blended to a uniform concentration. It has been surprisingly discovered that this particular complex (methylcyclopropene and alpha-cyclodextrin) was stable for over one year as judged by accelerated shelf life studies. Moreover, a powdered complex can be easily measured and packaged into appropriately-sized doses for treatment of plants. The method of delivery of the present invention provides a user-friendly application. It also promotes a lower initial dose of active compound and a decrease in the need for repeated applications as compared with previously proposed solid carrier systems. A variety of molecular encapsulation agents may be utilized in the present invention provided they have the correct cage structure to form a molecular trap for the compound capable of inhibiting the ethylene response in plants. Thus, as one skilled in the art would recognize, the use of other molecular encapsulation agents falls within the spirit and scope of the present invention. Cyclodextrins, also known as “Schardinger Dextrins”, are cyclic oligosaccharides composed of glucose units bonded together by alpha 1,4 bonds. The six-membered ring structure is named alpha-cyclodextrin, the seven membered ring is beta-cyclodextrin and the eight membered ring is gamma-cyclodextrin. Generally, compounds that are encapsulated fit inside of the oligosaccharide ring. As is well known, cyclodextrins are produced from starch of any selected plant variety such as corn, potato, waxy maize and the like. The starch may be modified or unmodified starch derived from cereal or tuber origin and the amylose or amylopectin fractions thereof. The selected starch in aqueous slurry at selected concentration up to about 35% by weight solids is usually liquefied as by gelatinization or treatment with liquefying enzyme such as bacterial alpha-amylase enzymes and then subjected to treatment with a cyclodextrin glucosyl transferase enzyme to form the cyclodextrin. The amount of the individual alpha, beta and gamma cyclodextrins produced by treating the starch with the glucosyl transferase enzyme will vary depending on the selected starch, selected glucosyl transferace enzyme and processing conditions. The parameters to select for glucosyl transferase enzyme conversion for the desired result in the amount of each individual cyclodextrin to be produced is conventional and well described in the literature. Separation and purification of the cyclodextrin thus obtained is also conventional and well known to those of skill in the art. In one embodiment, the cyclodextrin utilized in the complex of the present invention is alpha-cyclodextrin. However, as one skilled in the art will appreciate, any cyclodextrin or mixture of cyclodextrins, cyclodextrin polymers as well as modified cyclodextrins can also be utilized pursuant to the present invention. Cyclodextrins are available from American Maize Products Company, Hammond, Ind., as well as other vendors. In order to form a molecular encapsulation agent complex, the active compound and the molecular encapsulation agent molecules are mixed together in a solution for a period of time sufficient to form the complex. The complex is then removed from the solution and dried. The dried complex is then ready for use. As noted previously, the resulting complex of the present invention provides a number of advantages to manufacturers as well as ultimate consumers. Due to the ability of the cyclodextrin to entrap a large amount of cyclopropene, the present invention should lower the initial dosage of cyclopropene needed for treatment as compared with previously proposed solid carriers. Likewise, it should decease the need for repeated treatments of cyclopropene compared with previously proposed solid carriers. The potential of these advantages is demonstrated in the examples below which show the unexpected ability of the complex of the present invention to entrap large quantities of cyclopropene. A still further advantage of the present invention is the increased stability of the resulting methylcyclopropene/alpha-cyclodextrin complex as compared to compressed gas. Based on heat stability testing, it was determined that when concentrated methylcyclopropene gas was exposed to heat of about 50° C., a 75% to 100% reduction in concentration was observed. When left at room temperature, the concentrated gas lost 30% to 42% of its concentration. On the other hand, when the methylcyclopropene/alpha-cyclodexrin complex of the present invention was exposed to 50° C., only a 38% reduction in the concentration of methylcyclopropene was observed. When left at room temperature, there was no reduction in the concentration of methylcyclopropene from the methylcyclopropene/alpha-cyclodextrin complex. The present invention also provides a convenient product for commercial use. For example, select quantities of the complex of the present invention can be sealed into a package for retail and wholesale use. In one embodiment, the preferable package is made of polyvinyl alcohol. The inventors have discovered that polyvinyl alcohol increases the efficiency of release, reduces any exposure, and insures proper dosage. When the consumer is ready to use the complex, the consumer may either dissolve the powder in an aqueous solution (e.g., water) and expose the resulting solution to the plant. Understandably, various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. Therefore, the claims are intended to cover such changes and modifications. The Controlled Release of Compounds Capable of Inhibiting the Ethylene Response in Plants Controlled release of methylcyclopropene as well as other compounds capable of inhibiting the ethylene response in plants from a molecular encapsulation agent complex such as cyclodextrin is facilitated by the addition of an excess of water. Addition of an acid or alkaline substance to the water also facilitates a faster release of the active compound. Heating the water also facilitates a faster release of the active compound. Because methylcyclopropene has a high vapor pressure at normal working temperatures from 4 to 25° C., it quickly escapes into the atmosphere. By releasing methylcyclopropene from a complex in water in a closed container or room, the methylcyclopropene diffuses onto the ethylene receptor sites of all the plants within the room. Use of fans or other means to move the air for more suitable equilibration in the chamber is also often useful. Depending on the plant, generally a dose of less than 1 ppm (part per million) or preferably less than 500 ppb (parts per billion) of methylcyclopropene or some other active compound in the atmosphere of the sealed container or room for about 2-6 hours is sufficient to protect the plant or plant product from further ethylene damage. The Plants Applicable to the Present Invention The term “plant” is used generically in the present invention to also include woody-stemmed plants in addition to field crops, potted plants, cut flowers, harvested fruits and vegetables and ornamentals. Some of the plants that can be treated by the methods of the present invention are listed below. Plants treated by the compounds of the present invention that inhibit the ethylene response need to be treated at levels that are below phytotoxic levels. This phytotoxic level varies not only by plant but also by cultivar. When correctly used, the compounds of the present invention prevent numerous ethylene effects, many of which have been disclosed in U.S. Pat. Nos. 5,518,988 and 3,879,188, both of which are incorporated herein by reference in their entirety. The present invention can be employed to combat numerous plant ethylene responses. Ethylene responses may be initiated by either exogenous or endogenous sources of ethylene. Ethylene responses include, for example, (i) the ripening and/or senescence of flowers, fruits and vegetables, (ii) the abscission of foliage, flowers and fruit, (iii) the prolongation of the life of ornamentals, such as potted plants, cut flowers, shrubbery and dormant seedlings, (iv) the inhibition of growth in some plants such as the pea plant, and (v) the stimulation of plant growth in some plants such as the rice plant. Vegetables which may be treated by the methods of the present invention to inhibit senescence include leafy green vegetables such as lettuce (e.g., Lactuea sativa ), spinach ( Spinaca oleracea ) and cabbage ( Brassica oleracea; various roots such as potatoes ( Solanum tuberosum ), carrots (Daucus); bulbs such as onions (Allium sp.); herbs such as basil ( Ocimum basilicum ), oregano ( Origanum vulgare ) and dill ( Anethum graveolens ); as well as soybean ( Glycine max ), lima beans ( Phaseolus limensis ), peas (Lathyrus sp.), corn ( Zea mays ), broccoli ( Brassica oleracea italica ), cauliflower ( Brassica oleracea botrytis ) and asparagus ( Asparagus officinalis ). Fruits which may be treated by the methods of the present invention to inhibit ripening include tomatoes ( Lycopersicon esculentum ), apples ( Malus domes tica ), bananas ( Musa sapientum ), pears ( Pyrus communis ), papaya ( Carica papya ), mangoes ( Mangifera indica ), peaches ( Prunus persica ), apricots ( Prunus armeniaca ), nectarines ( Prunus persica nectarina ), oranges (Citrus sp.), lemons ( Citrus limonia ), limes ( Citrus aurantifolia ), grapefruit ( Citrus paradisi ), tangerines ( Citrus nobilis deliciosa ), kiwi ( Actinidia. chinenus ), melons such as cantaloupes ( C. cantalupensis ) and musk melons ( C. melo ), pineapples ( Aranae comosus ), persimmon (Diospyros sp.) and raspberries (e.g., Fragaria or Rubus ursinus ), blueberries (Vaccinium sp.), green beans ( Phaseolus vulgaris ), members of the genus Cucumis such as cucumber ( C. sativus ) and avocados ( Persea americana ). Ornamental plants which may be treated by the methods of the present invention to inhibit senescence and/or to prolong flower life and appearance (such as the delay of wilting), include potted ornamentals and cut flowers. Potted ornamentals and cut flowers which may be treated with the methods of the present invention include azalea (Rhododendron spp.), hydrangea ( Macrophylla hydrangea ), hibiscus ( Hibiscus rosasanensis ), snapdragons (Antirrhinum sp.), poinsettia ( Euphorbia pulcherima ), cactus (e.g., Cactaceae schlumbergera truncata ), begonias (Begonia sp.), roses (Rosa sp.), tulips (Tulipa sp.), daffodils (Narcissus sp.), petunias ( Petunia hybrida ), carnation ( Dianthus caryophyllus ), lily (e.g., Lilium sp.), gladiolus (Gladiolus sp.), Alstroemeria ( Alstroemaria brasiliensis ), anemone (e.g., Anemone bland ), columbine (Aquilegia sp.), aralia (e.g., Aralia chinesis ), aster (e.g., Aster carolinianus ), bougainvillea (Bougainvillea sp.), camellia (Camellia sp.), bellflower (Campanula sp.), cockscomb (Celosia sp.), falsecypress (Chamaecyparis sp.), chrysanthemum (Chrysanthemum sp.), clematis (Clematis sp.), cyclamen (Cyclamen sp.), freesia (e.g., Freesia refracta ), and orchids of the family Orchidaceae. Plants which may be treated by the methods of the present invention to inhibit abscission of foliage, flowers and fruit include cotton (Gossypium spp.), apples, pears, cherries ( Prunus avium ), pecans ( Carva illinoensis ), grapes ( Vitis vinifera ), olives (e.g., Olea europaea ), coffee ( Cofffea arabica ), snapbeans ( Phaseolus vulgaris ), and weeping fig ( Ficus benjamina ), as well as dormant seedlings such as various fruit trees including apple, ornamental plants, shrubbery, and tree seedlings. In addition, shrubbery which may be treated according to the present invention to inhibit abscission of foliage include privet (Ligustrum sp.), photinea (Photina sp.), holly (Ilex sp.), ferns of the family Polypodiaceae, schefflera (Schefflera sp.), aglaonema (Aglaonema sp.), cotoneaster (Cotoneastersp.), barberry (Berberris sp.), waxmyrtle (Myrica sp.), abelia (Abelia sp.), acacia (Acacia sp.), and bromeliades of the family Bromeliaceae. EXAMPLES While many of the examples described below are related to the synthesis molecular encapsulation agent compexing and delivery or application of methylcyclopropene to plants, the same synthesis methods have also been found effective for cyclopropene and other cyclopropene derivatives and the same molecular encapsulation agent compexing and delivery or application methods have also been found effective for cyclopropene, cyclopentadiene, diazocyclopentadiene and their derivatives. Methylcyclopropene was used in the examples because it is one of the most active derivatives of cyclopropene that binds to the ethylene receptor site of plants. Example 1 Synthesis of Methylcyclopropene At room temperature, nitrogen gas (99.95% pure) is pumped into a nitrogen vessel (35½″×28″×32″) containing either sodium amide powder (90%-NaNH 2 ) or lithium diisopropylamide powder (97%-[(CH 3 ) 2 CH] 2 NLi). A separate powder addition vessel is also purged with the same nitrogen gas. Purging with nitrogen is necessary because of the reactivity of the above-mentioned Lewis bases with air, and to eliminate any contamination before conducting the synthesis reaction. In the powder addition vessel containing the inert atmosphere, the sodium amide (or an equivalent molar concentration of lithium diisopropylamide) is added in an amount ranging from 365-1100 grams, with the larger amount being preferred. To weigh the proper amount of the Lewis base, all weighing is performed in a nitrogen box with nitrogen purging to eliminate oxygen and the threat of spontaneous ignition of the base. Special care is important when working with such bases for proper safety. Once the Lewis base in powder form is completely added, the openings in the powder addition vessel that were used for purging are sealed off to exclude air. The powder addition vessel is attached to the main system. The reaction vessel, which already has been purged with nitrogen and has been partially evacuated, is opened to the powder addition vessel to allow the powder to fall into the reaction vessel with the aid of nitrogen flow. Nitrogen enters the powder addition vessel during transfer of the Lewis base. After the powder is transferred into the reaction vessel, the ball valve is closed. After the powder is added, a light mineral oil (dried with molecular sieves) or another equivalent solvent is added by opening the connecting ball valve and allowing it to pour into the reaction vessel with the aid of nitrogen flow. The amount of oil added during the reaction can vary from 1-47 liters, with the higher amount 47 liters being preferred. The reaction vessel is then purged and closed. The reaction vessel temperature is adjusted to a temperature anywhere from 0° C. to 75° C., and preferably about 20° C. to start the reaction. The temperature can be raised or lowered by heating or chilling the jacket using a circulating pump. Should the holding capacity of the vessel be exceeded, the procedure is repeated. During the addition of ingredients, the contents of the reaction vessel are stirred with a propeller mixer, but splashing of the contents should be avoided. After mixing for 1-60 minutes, and preferably for about 20 minutes, 3-chloro-2-methylpropene is added to the reaction vessel in an amount ranging from 0.15-1.0 liters. During the addition of the 3-chloro-2-methylpropene, there is continuous purging with nitrogen gas. The liquid reactant 3-chloro-2-methylpropene is added slowly over a period of 20 minutes. During this addition, the temperature of the reaction vessel is monitored and kept at less than 40° C. Once the 3-chloro-2-methylpropene is completely added, the vessel should be agitated for an additional 1-30 minutes, and preferably for 15 minutes, using the propeller mixer discussed above. A reaction vessel pressure of about two atmospheres is used in this example. After all the 3-chloro-2-methylpropene has been reacted, the desired end-product, methylcyclopropene, exists as a sodium salt. To react the remainder of the Lewis base and facilitate liberation of the methylcyclopropene product, the nitrogen purge is stopped and water is added ranging from 0.00-1.47 liters by adding the water under positive pressure over a period of 1 hour. Once all the water has been added, a ball valve connecting the vessel with the condenser is opened. Any pressure is then released by bubbling the gaseous methylcyclopropene product through a mixture of cyclodextrin dissolved in water (as explained later in this example). Once the reactive ingredients have been mixed, the headspace gas in the reaction vessel is transferred to a 5 gallon mixing vessel, already lined with a bag filter (5-25 micron mesh plastic) and containing 0.9-2.8 kg of alpha-cyclodextrin, 0.575 liters of a buffer solution. The alpha-cyclodextrin is weighed out on an electronic scale and transferred to the mixing vessel by pouring it through the opening of the mixing vessel. The buffer solution is prepared by combining a 0.2 M sodium acetate solution with a 0.2 M acetic acid solution which gives a pH in the range of 3 to 5. The headspace gas in the reaction vessel is transferred by pulling a vacuum on the mixing vessel to 15 psi, closing the condenser/reaction vessel ball valve and opening the ball valve linking the condenser (15 coils, ⅜′) to the mixing vessel, allowing the gas in the condenser, which has been chilled at a temperature of 0-10° C. by a chilling circulating pump, to pass through to the mixing vessel. The reason for chilling the gas in the condenser is to significantly reduce any 3-chloro-2-methylpropene from entering the mixing vessel. The lower boiling point of methylcyclopropene (which is approximately 12° C.) compared to the higher boiling point of the 3-chloro-2-methylpropene (which is 70° C.) prevents the later from entering the mixing vessel. The condenser is also positioned in such a way that the 3-chloro-2-methylpropene will return to the reaction flask. Once the gas passes from the condenser, the condenser/mixing vessel ball valve is closed, and the condenser/reaction vessel ball valve is opened allowing the headspace gas from the reaction vessel to flow into the condenser. The condenser/reaction vessel ball valve is then closed, the condenser/mixing vessel ball valve is reopened, and the gas flows to the mixing vessel. Once the initial head space is transferred over to the mixing vessel, a vacuum will begin to be created in the reaction vessel which can be detected by reading the mounted pressure gauge. When this occurs, the reaction vessel is filled with nitrogen gas (99.95% pure) by closing any connections to the rest of the system, and allowing the nitrogen gas to enter through the nitrogen inlet valve when a slight vacuum occurs. Once the reaction vessel has been filled with nitrogen gas, which will be identifiable by reading the mounted pressure gauge, the head space gas from the reaction vessel is once again transferred to the mixing vessel. The process is repeated until the mixing vessel is filled with gas as indicated by the pressure gauge. A minimum concentration of 80,000 ppm of methylcyclopropene is preferred in the mixing vessel at this step. This concentration can be calculated the same way as previously mentioned. After the mixing vessel is filled, all the connections are closed, and the vessel is removed from the system and placed on a shaker, which is allowed to shake so that the mixture is completely agitated for 1-5 hours at less than 70° C. The methylcyclopropene is trapped in the alpha-cyclodextrin during this unit operation. After the contents are agitated, the mixing vessel is allowed to equilibrate for 0-72 hours, and preferably for at least 24 hours at a temperature of 0-30° C. (preferably about 4° C.). Next, the contents in the mixing vessel, if containing the buffer solution, are filtered out by vacuum filtration, by connecting a vacuum pump at the bottom outlet of the mixing vessel, which will remove the buffer solution from the mixture while the powder remains in the confines of the filtering bag. Once all the buffer solution has been removed, the wet powder containing the entrapped methylcyclopropene is transferred onto a plastic tray and allowed to air dry for 24-48 hr. Once it has been dried, the filtered material is ground in a powder grinder, creating a fine powder (approximately 100 mm mesh). If the material in the mixing vessel did not contain the buffer solution, no filtering or grinding is needed. After the powder is ground, it is placed in a powder mill and allowed to mix for 5-10 minutes at approximately 100 rpm. Once the powder is mixed, it is analyzed and mixed with dextrose or dextrin to the desired concentration of methylcyclopropene entrapment. If the amount of entrapped methylcyclopropene is lower than the desired concentration, it is bulked and milled with other samples. In both cases, after the newly formed powders are mixed, they are analyzed again to insure that they meet specifications. Per every reaction vessel made, 2-7 mixing vessels can be filled, depending on the amount of methylcyclopropene remaining in the reaction vessel after the head space has been transferred. However, depending on the amount of methylcyclopropene gas remaining in the reaction vessel, a waiting period of 0-3 hours may be necessary for the reaction vessel to produce more methylcyclopropene gas. Once the mixing vessels are filled, and there is not enough methylcyclopropene gas to fill more vessels, the reaction vessel is removed from the system, but kept inside a hood. Cleaning: Water is slowly added to the reaction vessel to begin the cleaning process. Water is added slowly due to its reactivity with excess sodium amide. When the sodium amide is mixed with water, ammonia and sodium salts are formed. Once the reaction vessel has been washed completely, it is allowed to air dry completely before it is reused. The three addition vessels are cleaned once a week with water. They are thoroughly rinsed with water until no reactants are found. All the piping/tubing and condenser are also cleaned thoroughly once a week with water. The mixing vessels and inner filter linings are thoroughly washed with water after every use. All waste water is disposed of according to governmental regulations. Cleanliness, in addition to purging of the vessels with nitrogen gas and the cooling of gas in the condenser are safety steps that also prevent any contamination of the methylcyclopropene. Example 2 Manufacture of Methylcyclopropene Using 3-bromo-2-methylpropene and Lithium Diisopropylamide Under a nitrogen atmosphere, approximately 0.1 to 0.5 moles of lithium dilsopropylamide are placed into a two liter container. 100 ml of a non-volatile organic solvent, such as dried mineral oil, is then added to the container. Approximately 0.1 to 0.5 moles of 3-bromo-2-methyl propene is then added to the container. A 1:1 molar ratio of the lithium amide and the halogenated methyl propene is utilized. The exothermic solution is then allowed to react until no heat was given off. Then, approximately 0.1 to 0.5 moles of a polar solvent, such as water, is added to the container. The head space of the reaction is displaced with a syringe or by sweeping with nitrogen through a condenser and cold trap, connected to a vacuum system into a flask containing approximately 50 to 200 grams of alpha-cyclodextrin and 50 to 200 ml of water buffered at a pH of approximately 4 to 6. The cold trap is kept at a temperature of approximately 0-10° C., whereas the condenser is at a temperature ranging from approximately 10-20° C. This solution is then stirred for about 1 to 24 hours at a temperature ranging from room temperature to 45° C. Lastly, after the solution has reacted, the excess water is filtered out. Then the slurry is dried to a powder form. In this manner, a complex is formed in accordance with the present invention. Plants are preferably exposed to a non-phytotoxic amount of the active compound. In one embodiment, approximately 0.1 gram of an encapsulated cyclopropene or derivative thereof per 50 to 500 cubic feet of atmosphere to be treated is dissolved in an aqueous solution and exposed to plants to prolong their life or inhibit their ethylene response. The methods of the present invention involve initially the step of providing the complex of the present invention. Then the complex is dissolved to release the gaseous form of the complex. A variety of solutions may be utilized and generally encompass polar solvents, such as water, DMSO, ethanol and methanol. To expose the plant to the gaseous cyclopropene or derivative thereof, the aqueous solution is preferably positioned near the plant. Alternatively, the powder may be placed in an aerosol can containing sufficient water and 40-50 psi of compressed gas. Then, the gaseous cyclopropene may be sprayed onto the plant. Example 3 Release of Methylcyclopropene from Cyclodextrin To release methylcyclopropene from the cyclodextrin molecular encapsulation agent and treat plants, the first thing that should be done is to place the plants into a closed environment, preferably at elevated temperatures, preferably from 13° to 24° C. The amount of methylcyclopropene should preferably be from 100 to 500 ppb (parts per billion of methylcyclopropene in the atmosphere after release) for crops like carnations. The amount of molecular encapsulating agent complex needed to release the proper amount of methylcyclopropene or any other compound capable of inhibiting the ethylene response in plants will depend upon the plant being treated and the specific complex formulation used. Before the active compound is released, the treating chamber is closed and the air flow arranged so that all the plants in the closed chamber will be treated. The methylcyclopropene/alpha-cyclodextrin complex is then added to water. The amount of water used should be at least 10 times the weight of the cyclodextrin and preferably 100 times the weight of the cyclodextrin. Other factors that facilitate a more complete release of the active compound capable of inhibiting the ethylene response in plants are the addition of an acidic or alkaline agent to the water so as to buffer the water to an acidic or basic pH. Additionally, the water containing the cyclodextrin complex can be heated up to 45° C. to facilitate a better release of the methylcyclopropene. The release of methylcyclopropene is faster with heating or changing pH, but in lieu of these treatments, use of a greater amount of water is sufficient to obtain a full release of the methylcyclopropene from the cyclodextrin complex. The plant treatment time is usually at least one hour, but preferably at least 6 hours unless the plants are being held at a temperature less than 15° C. in which case more time is preferred (sometimes as much as 10 hours). Once the plants are treated, the sealed chamber may be opened if desired. The methylcyclopropene is now protecting the plants because it has blocked all the available ethylene receptor sites. This treatment will protect the plants from the action of ethylene until the plant grows new unblocked ethylene receptor sites. Example 4 Comparative Experiments The following comparative examples demonstrate the effectiveness of the molecular encapsulation agent complexes of the present invention. The comparative examples demonstrate the benefits of the present invention (utilizing an alpha-cyclodextrin/methylcyclopropene complex) as compared to traditional solid inert carriers, such as wood flour and molecular sieves. Specifically, these comparative examples demonstrate the amount of methylcyclopropene absorbed by traditional solid carriers as compared to that entrapped by utilizing a molecular encapsulation agent, alpha-cyclodextrin, of the present invention. The Wood Flour Comparative Example This experiment evaluates the differences between utilizing the complex of the present invention with a solid carrier, as proposed in U.S. Pat. No. 5,518,988. Specifically, the inventors tested the absorption amount, if any, of methylcyclopropene onto wood flour. The wood flour used was obtained from American Wood Fibers and was identified as #10010 Hardwood. To evaluate the amount of absorption of methylcyclopropene, 0.01 grams of wood flour (previously exposed to methylcyclopropene in a buffered water solution as described below for the molecular sieve comparative example) was weighed out in a 25 ml vial, and dissolved with 5 ml of deionized water. Then, 1 ml of the headspace from the vial was injected into a gas chromatograph (a total of 20 ml of headspace was tested). In addition to testing with 0.01 grams of wood flour, 0.1 grams was also tested. Alpha-cyclodextrin was also tested under the same conditions. It was experimentally found that no methylcyclopropene attachment to the wood flour was detectable. This shows that use of a dry absorbent, such as wood flour, was not effective in absorbing methylcyclopropene. The Molecular Sieve Comparative Example To evaluate the differences between utilizing a molecular encapsulation agent complex of the present invention and molecular sieves, another comparative experiment was also conducted. Molecular sieves were selected for these comparison tests because they are one of the most common carriers of chemicals in the chemical industry. Two types of molecular sieves were utilized in this comparative example, 13X and 5A. Both were obtained from the Aldrich Chemical Company in Milwaukee, Wis. Each molecular sieve was first dried at 50° C. for 30 minutes before being used. 25 grams of each were then placed in separate 250 ml Erlenmeyer flasks and cooled to −80° C. by placing then in a dry ice/acetone bath. 20 ml of methylcyclopropene (approximately 60,000 ppm) was injected into the flask and allowed to sit for 24 hours either at room temperature or at 4° C. 1 gram of molecular sieve was then weighed in a 20 ml vial, and 5 ml of deionized water was added to release the methylcyclopropene. 1 ml of the headspace from the vial was injected into a gas chromatograph to determine the concentration of methylcyclopropene adsorbed onto the molecular sieves. The following methylcyclopropene release data was obtained. Molecular Sieve/Condition Amount Released 13X cooled to 4° C. for 24 hr. 15 ppm 13X room temperature 24 hr. 15 ppm 5A cooled to 4° C. for 24 hr. None detected 5A room temperature 24 hr. None detected The Alpha-Cyclodextrin Complex Comparative Example The alpha-cyclodextrin/methylcyclopropene complex used in this example was made by trapping 80,000 ppm of methylcyclopropene in a 5 gallon mixing vessel with 1.3 kg of alpha-cyclodextrin in 0.575 liters of buffer solution having a pH of 4. The buffer solution was made with 0.2 M sodium acetate and 0.2 M acetic acid solutions. This is referred to as the “wet” cyclodextrin loading in the results discussed below. A “dry” cyclodextrin loading was also run. In the dry experiment, the methylcyclopropene was contacted with dry alpha-cyclodextrin, i.e., cyclodextrin that was not in an aqueous solution. In both experiments, the vessel was chilled to 4° C. and the contents mixed for 24 hours. Once the methylcyclopropene is trapped onto the cyclodextrin, the pressure fell from about 2 atmospheres to a vacuum. Nitrogen gas was then added to atmospheric pressure. The buffer solution was removed by filtering through a filtering bag within the vessel and the cyclodextrin cake was transferred to a plastic tray and allowed to air dry for 48 hours. The dry cyclodextrin with entrapped methylcyclopropene was ground with a powder grinder to a 100 mm mesh size. The complex was stored for two weeks before analysis. To evaluate the amount of methylcyclopropene complexed or trapped by alpha-cyclodextrin, 0.01 grams of cyclodextrin (previously exposed to methylcyclopropene as described above) was weighed out in a 25 ml vial, and dissolved with 5 ml of deionized water. Then 1 ml of the headspace from the vial was injected into a gas chromatograph to determine the concentration of methylcyclopropene in the complex. The results are shown below. The methylcyclopropene was absorbed either wet or dry onto the cyclodextrin and then evaluated as described above. Cyclodextrin loading Amount Released water 500-1000 ppm dry 200-500 ppm These results demonstrate that the 13X molecular sieve was only capable of taking up 15 ppm of methylcyclopropene. The heat of adsorption may have caused the decay of some methylcyclopropene according to the chromatographic results, but it is estimated that no more than 15 ppm could have been lost. In contrast, the results from the molecular encapsulation agent complex of the present invention demonstrate a substantially complete entrapment of the methylcyclopropene. These dramatic differences in release amounts of methylcyclopropene could not have been expected from the literature. Clearly, the molecular encapsulation agent complex of the present invention is far superior to the passive absorption to solids taught in U.S. Pat. No. 5,518,988.

1a

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to a device for preparing a cleaning liquid for a milking device. The device includes a buffer vessel for cleaning liquid, a metering system for a cleaning agent, a water feed and a mixing vessel for mixing the cleaning agent with the water supplied, which mixing vessel is provided with an outlet to the buffer vessel and may optionally form part of the buffer vessel. 2. Description of the Prior Art Devices of this kind are known, for example, from EP-A-0 399 604, filed by the same applicant, in which hot water can be metered into a vessel and cleaning agent is metered using the pump. The cleaning agent is supplied to the farmer in a container which contains the cleaning agent in liquid form. It is drawn out of the container by means of the pump. The cleaning agents are generally more or less aggressive substances which have to be handled very carefully, since otherwise spillage can damage clothing and the like. Also, empty containers are contaminated to such an extent that they have to be treated as chemical waste and disposed of as such. SUMMARY OF THE INVENTION The object of the invention is to avoid these drawbacks and, to this end, the metering system comprises a chamber for storing dry cleaning agent, as well as metering means, which are connected to the chamber, for metering an adjustable quantity of dry cleaning agent into the mixing vessel. Due to the fact that the cleaning agents are supplied and metered in dry form, there is less risk of spillage and the packaging also causes less contamination. According to a further improvement, the cleaning agent is in tablet form. By pressing the cleaning agent into tablets, it is made easy to handle and manipulate without loose material being released, with the result that the cleaning agent can be removed from the packaging and metered in a simple manner. According to a further improvement, the metering means are provided with a metering slide for removing at least one tablet of cleaning agent from the chamber and moving it to the mixing vessel. As a result, cleaning agent can be metered in a simple manner. According to a further improvement, the metering means are provided with sealing means for sealing off the chamber from steam. Consequently, the cleaning agents in the chamber cannot be wetted by moisture from the mixing vessel or from the humid atmosphere in a milking shed. According to one embodiment of the invention, the metering slide comprises an opening which can be moved from a first position, in which the opening is in communication with the chamber, to a second position, in which the opening is in communication with the mixing vessel. This prevents open communication between the chamber and the mixing vessel, so that there is no possibility of moisture from the mixing vessel passing into the chamber. According to a further improvement of the invention, the metering means and the water feed are provided with operating means for automatically metering cleaning agent and water, respectively, into the mixing vessel. As a result, it is possible for the user to prepare cleaning liquid in a simple manner. The invention also relates to a milking device which is provided with a control system for an automatically operating cleaning system, in which according to a further improvement the operating means are coupled to the control system of the automatically operating cleaning system. As a result, it is possible to clean the milking system automatically. According to one embodiment of the invention, the mixing vessel is provided with two or more metering systems containing at least two types of cleaning agent. As a result, cleaning can be carried out in sequence with, for example, an acidic cleaning agent, which allows systems containing at least two types of cleaning agent. As a result, cleaning can be carried out in sequence with, for example, an acidic cleaning agent, which allows the lines to be descaled, and an alkaline cleaning agent for fat-dissolving. It is also possible to add, for example, a disinfectant at the same time as the alkaline cleaning agent, using a third metering system. According to one embodiment of the invention, the chamber is formed by a casing which is closed at the top and is positioned in a sealing ring. As a result, a sealed chamber is formed in a simple manner. According to a further embodiment of the invention, the metering system is provided with indicator means for displaying the amount of cleaning agent present in the chamber. The invention also relates to a cleaning agent for alkaline cleaning a milking device comprising alkaline agent such as caustic soda combined with wetting agent. According to the invention the cleaning agent is distributed and stored before use as a combination tablet comprising the agent for alkaline cleaning and a disinfectant. By combining the alkaline agent, the wetting agent and the disinfectant in a tablet these agents always have the desired ration of concentration, which is advantageous when cleaning a milking device. The invention further relates to a casing with cleaning agent for cleaning a milking device. According to the invention the cleaning agent comprises tablets for alkaline cleaning and tablets for acidic cleaning whereby the tablets are placed on the casing in the sequence of desired used. In this it is ensured that the different cleaning agents are used in the correct order for optimal cleaning results. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be explained below with reference to a number of exemplary embodiments which are discussed with reference to a drawing, which shows a diagrammatic view of a metering device with a mixing vessel. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A mixing vessel 8 is positioned above a buffer vessel 16 . The mixing vessel 8 can be filled via a water feed 12 and via an electrically operated valve 11 , using a metering pipe 13 . When the water level in the mixing vessel 8 has risen above a defined level, the vessel is emptied by the siphon effect using a siphon line 14 . The siphon line 14 is arranged in the cover of the buffer vessel 16 . A metering device is arranged above the mixing vessel 8 , which metering device comprises a housing 5 , an which a casing 2 is positioned via a connection opening with a seal 1 . A metering slide 7 can be moved in the horizontal direction in the housing 5 using a drive 9 . A metering opening 6 is formed in the metering slide 7 , which opening can communicate in sequence with an opening in the housing 5 into the mixing vessel 8 and an opening in the housing 5 into the connection opening 1 holding the casing 2 . A stack of tablets 3 which fit into the metering opening 6 in the metering slide 7 is positioned in the casing 2 . By moving the metering slide in the horizontal direction, in each case one tablet is moved from the casing 2 into the mixing vessel 8 . A seal 4 is arranged around the metering slide 7 , in the housing 5 . As a result, it is impossible for any moisture to penetrate along the metering slide 7 into the casing 2 when the metering opening 6 has been moved to above the mixing vessel. On its open side, the casing 2 is provided on the outside with a smooth rim which interacts with the seal of the connection opening 1 , so that it is also impossible for any moisture to penetrate into the casing 2 by this route. As a result, the tablets 3 in the casing 2 remain as dry as possible. The device functions as follows. One or more tablets 3 are moved into the mixing vessel 8 via a control system 18 using the drive 9 . This is achieved by moving the metering slide 7 in the horizontal direction, with the result that one tablet each time falls into the mixing vessel 8 . Via an operating cable 10 , a signal is then transmitted to the electrically operated valve 11 , which consequently opens, causing water to flow out of the water feed 12 into the mixing-vessel 8 . This water is preferably hot water at a temperature of approximately 80 to 90° C., with the result that the tablets 3 dissolve rapidly. After the mixing vessel 8 has been almost filled, meaning that approximately one litre of hot water has flowed in, and after the tablets 3 have been dissolved, the liquid will flow out of the mixing vessel 8 , via the siphon line 14 , into the buffer vessel 16 . The buffer vessel 16 is then filled to the desired level by keeping the valve 11 open for a sufficient period of time or by filling the buffer vessel 16 with hot water in a different way. The buffer vessel 16 has a volume of, for example, from 70 to 120 litres and is connected in a known manner to a milking system, which is not shown in more detail and may be designed in a known manner. The liquid can be removed from the buffer vessel 16 in a known manner and circulates through the milking system 17 , cf. also in this regard the abovementioned application EP 0 399 604, for example. The milking system 17 may be a simple milking installation, in which case the user starts the cleaning cycle himself, but may also be an automatically operating milking system which is periodically cleaned using an automatic system, as is employed, for example, with a milking robot. To clean a milking system, acidic cleaning and alkaline cleaning are employed in sequence. For acidic cleaning, which takes place, for example, every 2 to 3 days, sulfamic acid is used, for example 3 tablets containing a total of 60 grams of acid are used. For the alkaline cleaning, use is made of a combination of caustic soda, for example 40 grams, and, for example, 40 grams of disinfectant, such as sodium dichloroisocyanate. The alkaline cleaning is carried out daily and is alternated with an acidic cleaning which takes place, for example, every 4th cleaning operation. The tablets employed have a diameter of 34 mm and each weigh approximately 20 grams. The internal diameter of the casing 2 in which the tablets 3 are stored is, for example, approximately 40 mm. Wetting agents are added to the caustic soda tablets, so that a fat-emulsifying action is generated. This is important in particular for milking installations in which milking continues throughout the day, such as for example in the case of automatic milking devices in which the milking cups are automatically attached to the cows' udders using a robot. Since the buffer vessel 16 has to be provided with various cleaning agents, it is possible for a plurality of metering systems to be positioned above the buffer vessel. In this case, use may be made of, for example, three identical metering systems with three mixing vessels 8 , with different tablets positioned in each metering system. It is also conceivable to position, for example, three casings with three metering slides 7 above a mixing vessel, or to design the metering slide 7 in such a manner that different tablets can be taken from different casings at the same time or in sequence. According to another embodiment of the device, the cleaning agents which are used for one cleaning cycle are combined to form a single combination tablet. This means that in this case, by way of example, the caustic soda and the disinfectant are combined in a single tablet, with separating means, for example, such as a separating layer of neutral substance being arranged between the caustic soda and the disinfectant. It is also possible to package the acidic and alkaline cleaning agents in one casing, in which case the different substances are packaged, for example, in water-soluble film in order to avoid undesirable reactions between the substances. In this case, the tablets 3 are placed in the casing 2 in the desired order, with one dose (for example of three tablets) of acidic cleaning agent being positioned after every three doses (for example of three combination tablets) of alkaline cleaning agent. As a result, the desired cleaning takes place regularly in the desired order. In order to avoid errors when metering cleaning agent, the device may also be provided with a system which indicates how much cleaning agent is still present. This may be a simple mechanical indicator displaying the number of tablets in the casing; if appropriate, it may also be a mechanical counter which indicates the number of times that the metering slide has metered tablets. Another way of displaying the quantity can be realized using the control system 18 which records how many tablets have been metered since the last time that a new casing containing tablets was put in place. It is also possible for means which indicate how much powder is still present to be present in systems which use powder instead of tablets. In another embodiment of the metering device, the mixing vessel 8 is omitted and the tablets are metered directly into the buffer vessel 16 . In this embodiment, it is assumed that the tablets 3 dissolve immediately in the hot water, and if appropriate additional measures are employed, such as a separate mixing chamber in the buffer vessel 16 or, if appropriate, an agitator.

1a

BACKGROUND OF THE INVENTION [0001] This invention relates to apparatus used for agricultural irrigation, and more specifically, to a linear water feed mechanism that automatically and successively engages and disengages spaced hydrants mounted on a water supply pipe extending alongside or through a field to be irrigated. [0002] Mobile irrigation systems having elevated boom or truss assemblies carrying multiple sprinklers are typically of the center pivot-type or the linear- (or lateral-) move-type. In a center-pivot machine, the elevated truss assembly pivots about an upright standpipe that supplies water to the sprinklers attached to the truss assembly. In a linear-move machine, the elevated truss assembly is carried on mobile, wheeled towers that move the machine linearly along a path that is perpendicular to the elevated boom or truss. Typically, the linear-move machine travels from one end of a field to the other and back again, and sprinkling typically occurs in both directions. [0003] While linear-move machines can irrigate more area than center-pivot machines by reason of the resulting rectangularly-shaped irrigation pattern, the linear-move machines have proven to be problematic in several respects. The most significant problem relates to the manner in which water is supplied to the machine. In some cases, the machine travels alongside an open ditch or canal from which water is continuously removed. Ditch water is typically filled with dirt and/or debris that can clog the sprinkler nozzles. In other cases, one or more hoses are dragged by the machine the length of the field, requiring one or more manual attachment/detachment procedures and attendant issues of hose management. In still other cases, complex mechanisms have been proposed for automatic docking with hydrants spaced along the length of a water supply pipe. One of the problems with this arrangement is that the hydrant risers have had to be held firmly in concrete or welded onto steel pipe. Alignment mechanisms have been complex and costly to maintain. As a result, reliable docking under various conditions has proven to be an elusive goal, and we are unaware of any automatic docking mechanisms that have achieved a significant degree of commercial success to date. BRIEF DESCRIPTION OF THE INVENTION [0004] This invention relates to a unique “floating” docking station assembly that can be added to essentially any new or existing linear-move machine. The docking station assembly is supported and controlled so as to reliably and effectively capture each hydrant, open the hydrant water-supply valve to permit water to be supplied to the sprinklers on the truss assembly, close the valve, and then disengage from the hydrant for movement with the machine to the next hydrant. The “floating” docking station as described herein also minimizes the load placed on the hydrant, thus permitting a simpler main line construction. [0005] The docking station per se is formed by a pair of housings sandwiched about a hydrant valve actuator. The two housings support multiple pairs of guide wheels adapted to engage a round plate or flange on the hydrants. The housings also support docking stops and related mechanical and electrical hardware for halting the movement of the machine and docking station when properly aligned with the hydrant valve, opening and closing the valve, and subsequently permitting the resumption of machine movement after the allotted sprinkling time has expired. The docking station is resiliently suspended, or hung, from a supporting frame that, in turn, supports related hydraulic and electrical hardware as described in further detail below. [0006] Two pairs of vertically-oriented, angled guide wings respectively mounted on the front and back of the docking station supporting frame, along with one pair of horizontally-oriented front and back guide wings, assist in “capturing” the hydrants on the water supply pipe. In this regard, the docking station is operable in opposite forward and rearward directions of movement of the linear-move machine, with no change or adjustment in any of the component parts. For purposes of this application, therefore, any use of “front” or “forward,” etc. is intended to refer to the ends of the machine, docking station, etc. that lead in the direction of initial movement of the machine, i.e., along a path P 1 as shown in FIG. 1 . Use of “back” or “rearward,” etc. is intended to refer to the opposite ends of the machine, docking station, etc. that trail in the movement along path P 1 but that lead in movement in the opposite direction along a path P 2 . [0007] To ensure consistent and effective hydrant engagement via interaction with the guide wings, the docking station is arranged and supported so as to permit several degrees of movement: [0008] 1. The docking station is resiliently suspended or hung from its supporting frame by elongated coil springs (or equivalents) extending vertically between the docking station and the docking station supporting frame to enable up and down or vertical movement, but also to facilitate front-to-back, side-to-side and compound movements, i.e., tilting and twisting movements. [0009] 2. Spring-loaded, compressible tie rods extend horizontally between the supporting frame and docking station utilizing swivel bushings to enable front-to-back horizontal movement, but also to facilitate the limited vertical, side-to-side and compound movements. [0010] 3. The docking station and its supporting frame are also movable laterally on a carriage or trolley along a pair of rails extending perpendicularly to the path of movement of the machine so as to permit a wide range of lateral adjustment to accommodate a similarly wide range of hydrant misalignment situations. [0011] In addition to movements that relate to hydrant capture, the docking station trolley is also movable to any number of positions along a rigid side beam secured to one side of a drive tower of the linear-move machine. This allows for manual or automatic adjustment of the water distribution pattern between the forward and return movements of the linear-move machine, or for subsequent forward movements along the path as further described herein. [0012] In order to facilitate the docking operation, a new hydrant design has been adopted for use with the docking station of the linear-move machine. The hydrant in accordance with an exemplary embodiment includes a standard vertical pipe or riser fixed to the water supply pipe. At the upper end of the riser, a valve housing is attached by any suitable means and incorporates a spring-loaded valve assembly. The upper end of the valve housing is formed with an exterior, round, horizontal flange or plate that cooperates with the docking station during capture of the hydrant. The valve itself projects above the top of the flange to facilitate alignment with the hydrant valve actuator on the docking station. Alternatively, existing hydrant risers with compatible valves may be modified simply to include the round flange or plate to facilitate capture. Another alternative is the use of a conversion kit to render existing hydrants compatible with the docking station. [0013] The hydrant valve actuator carried by the docking station includes a housing that incorporates a piston/cylinder, the piston portion of which is movable within an enlarged chamber in the actuator housing. “Extend” and “retract” cavities are formed on either side of (i.e., above and below) the piston portion (or simply “piston”) with the assistance of a pair of rolling diaphragms attached between the piston and the actuator housing. Briefly, water under pressure introduced into the “extend” diaphragm cavity will push the piston/cylinder downwardly such that the lower edge of the cylinder will engage the hydrant valve and push it downwardly away from the valve seat to open the valve. Water can then be supplied to the sprinklers on the truss assembly via another conduit connecting the valve actuator to a distribution pipe on the truss assembly. When a pre-programmed sprinkling time has expired, water under pressure introduced into the “retract” cavity will drive the piston/cylinder upwardly and back into the hydrant valve actuator, closing the valve prior to movement to the next hydrant. [0014] It is another feature of the invention to facilitate different operating modes for the linear-move machine. For example, the machine may be used in a simple start/stop irrigation mode where the docking station is fixed to the side beam at the desired location, and the machine moves from hydrant to hydrant, stopping at each for a pre-programmed period of time for sprinkling. The water supply is cut off by a main control valve while the machine moves to the next hydrant. [0015] It is also possible to manually adjust the position of the docking station along the side beam to vary the sprinkling pattern, for example, on the return path of the linear-move machine, to thereby provide more uniform application of water in the irrigated field. Alternatively, well-known drive and control devices may be utilized to automatically move the docking station along the side beam from one position to another. [0016] In another mode, a second movable side beam may be mounted adjacent the first fixed side beam. The docking station is mounted on the second movable beam (or telescoping arm) for movement from one end of the arm to the other, while the telescoping arm itself is movable from an extended forward position to an extended rearward position relative to the fixed beam. This arrangement allows the docking station to engage a first hydrant, with the docking station at the forward end of the telescoping arm, and the telescoping arm in its extended forward position. As the linear-move machine (and fixed beam) moves forwardly, the telescoping arm slides (relative to the fixed side beam and hence the machine as a whole) to an extended rearward position, causing the docking station to be driven to the rearward end of the telescoping arm. After disengagement from the first hydrant valve, the telescoping arm and docking station are moved to their extended forward positions for engagement with the second hydrant valve. This cycle is repeated as the linear-move machine continues to travel the length of the field. [0017] In a full automatic mode, additional hardware changes are required. In the exemplary embodiment, parallel inner and outer fixed beams are attached to the end tower of the linear-move machine, and a docking station is mounted for reciprocatory movement on each. Flexible hoses connect each docking station to the distribution pipe on the truss assembly of the linear-move machine. At the same time, the water supply pipe is modified to the extent that alternate hydrants are offset in opposite lateral directions from the supply pipe to permit engagement with the respective inner and outer docking stations. The docking stations are movable along the respective inner and outer fixed beams by any suitable drive mechanism. In an exemplary mode of operation, the outer docking station will be located at the forward end of the outer fixed beam and engage a first outer hydrant. As the linear-move machine moves forward, the outer docking station will remain engaged and the inner docking station will move along the inner fixed beam and into engagement with the first inner hydrant. The outer docking station will disengage the first outer hydrant and move forward on the fixed outer beam, as the linear-move machine continues to move forward. This “leap-frog” process is repeated as the linear-move machine continues to travel along its path. In this way, no periodic shutdowns of the machine are required. [0018] In all cases, the various operations of the linear-move machine and docking station(s) are controlled by a Programmable Logic Controller (PLC) located on the drive tower of the linear-move machine, operatively connected to a series of solenoids carried by the docking station supporting frame that control the various mechanical movements of the components. The PLC may be electronically “inserted between” the linear-move machine's PLC and the linear-move machine itself to permit seamless integration of the operation of both the linear-move machine and one or more docking stations. [0019] Accordingly, in one aspect, the invention relates to a linear water feed apparatus for use in agricultural irrigation comprising a linear-move machine including a mobile truss assembly supporting a plurality of individual sprinklers and adapted for movement in a specified direction across a field to be irrigated, the truss assembly oriented transverse to the specified direction; a supply pipe arranged in the specified direction along or within the field to be irrigated, the supply pipe mounting a plurality of water supply hydrants at spaced locations along the pipe, each of the hydrants enclosing a water supply valve; and a docking station supported at one end of the truss assembly closest to the supply pipe, and adapted to engage and open successive ones of the water supply valves in the plurality of hydrants, the docking station assembly including a docking station suspended from a first frame for floating movement about at least three mutually perpendicular axes. [0020] In another aspect, the invention relates to a linear water feed for use in agricultural irrigation comprising a linear water feed machine including a wheel-mounted truss assembly supporting a plurality of individual sprinklers and adapted for movement in a specified direction across a field to be irrigated, the truss assembly oriented transverse to the specified direction; a supply pipe arranged in the specified direction along or within the field to be irrigated, the supply pipe mounting a plurality of water supply hydrants at spaced locations along the pipe, each of the hydrants enclosing a water supply valve; and a docking station supported on a first frame that is attached to an end of the truss assembly closest to the supply pipe, adapted to locate, engage and open successive ones of said water supply valves in the plurality of hydrants, the docking station supported for movement on a trolley in a direction substantially transverse to the specified direction, wherein the trolley includes a pair of parallel rails extending beyond the wheeled truss assembly, and further wherein the first frame is provided with plural rollers engaged with each of the parallel rails. [0021] In another aspect, the invention relates to a linear water feed for use in agricultural irrigation comprising a linear water feed machine including a wheel-mounted truss assembly supporting a plurality of individual sprinklers and adapted for movement in a specified direction across a field to be irrigated, the truss assembly oriented transverse to the specified direction; a supply pipe arranged in the specified direction along or within the field to be irrigated, the supply pipe mounting a plurality of water supply hydrants at spaced locations along the pipe, each of the hydrants enclosing a water supply valve; and a docking station supported on a first frame that is attached to an end of the truss assembly closest to the supply pipe, and adapted to engage and open successive ones of the water supply valves in said plurality of hydrants; wherein said docking station is supported at the one end of the truss assembly by means for allowing the docking station to move in up and down, side-to-side and front to back directions, and for allowing the docking station to simultaneously tilt and swivel relative to the first frame. [0022] In still another aspect, the invention relates to a linear water feed apparatus for use in agricultural irrigation comprising a linear-move machine including a mobile truss assembly supporting a plurality of individual sprinklers and adapted for movement in a specified direction across a field to be irrigated, the truss assembly oriented transverse to the specified direction; a supply pipe arranged in the specified direction along or within the field to be irrigated, the supply pipe mounting a plurality of water supply hydrants at spaced locations along the pipe, each of the hydrants enclosing a water supply valve; and a fixed side beam mounted on one end of the truss assembly closest to the supply pipe extending substantially parallel to the supply pipe; a telescoping arm mounted on the fixed side beam for movement in two opposite and parallel directions relative to the fixed side beam; a docking station including a support frame mounted on the telescoping arm for movement along the telescoping arm in the two opposite directions; the docking station resiliently suspended from the supporting frame for vertical, horizontal and compound movements. [0023] In still another aspect, the invention relates to a linear water feed apparatus for use in agricultural irrigation comprising a linear-move machine including a mobile truss assembly supporting a plurality of individual sprinklers and adapted for movement in a specified direction across a field to be irrigated, the truss assembly oriented transverse to the specified direction; a supply pipe arranged in the specified direction along or within the field to be irrigated, the supply pipe mounting a plurality of water supply hydrants at spaced locations along the pipe, the hydrants alternately offset in opposite transverse directions from the supply pipe, each of the hydrants enclosing a water supply valve; and a pair of laterally spaced, inner and outer beams fixed to a side of the truss assembly closest to the water supply pipe; a docking station including a supporting frame mounted on each of the pair of laterally-spaced inner and outer beams, each docking station having a hydrant valve actuator in fluid communication with a distribution pipe in the truss assembly, wherein the docking station on the inner beam is adapted to engage hydrants offset in one direction from the supply pipe, and the docking station on the outer beam adapted to engage hydrants offset in the opposite direction from the supply pipe. [0024] The invention will now be described in more detail in connection with the drawings identified below. BRIEF DESCRIPTION OF THE DRAWINGS [0025] FIG. 1 is a schematic plan view of a linear-move machine incorporating a docking station in accordance with the subject invention; [0026] FIG. 2 is an enlarged plan view, primarily in schematic form, illustrating the docking station mounted to the side of an end tower of the linear-move machine illustrated in FIG. 1 ; [0027] FIG. 3 is a perspective view of the docking station and end tower of the linear-move machine shown in FIG. 2 ; [0028] FIG. 4 is a left side elevation of the apparatus shown in FIG. 2 ; [0029] FIG. 5 is a front elevation of the apparatus shown in FIGS. 2-4 ; [0030] FIG. 6 is an enlarged side elevation of the docking station taken from FIG. 4 ; [0031] FIG. 7 is an enlarged detail of the docking station in plan view, as shown in FIG. 2 ; [0032] FIG. 8 is a perspective view of one of two docking station housings incorporated in the docking station shown in FIGS. 1-7 ; [0033] FIG. 9 is a perspective view taken from the opposite side of the docking station housing shown in FIG. 8 ; [0034] FIG. 10 is a perspective view of the hydrant valve actuator incorporated in the docking station in FIGS. 1-7 ; [0035] FIG. 11 is a partial perspective view of an upper portion of the docking station shown in FIGS. 1-7 , including the docking station trolley and supporting frame; [0036] FIG. 12 is a perspective view similar to FIG. 11 , but rotated 90°; [0037] FIG. 13 is a partial simplified side elevation of the docking station when in initial engagement with a hydrant; [0038] FIG. 14 is a view similar to FIG. 13 but directionally reversed and with the hydrant fully engaged and aligned within the docking station; [0039] FIG. 15 is a rear elevation view of the docking station and hydrant as shown in FIG. 13 , with the hydrant fully engaged within the docking station; [0040] FIG. 16 is a simplified plan view of the docking station, with vertical and horizontal guide wings and suspension components removed; [0041] FIG. 17 is a right front perspective view of the docking station and hydrant shown in FIG. 15 ; [0042] FIG. 18 is a cross section taken through the hydrant valve and hydrant valve actuator, in a valve closed position and with the hydrant fully engaged within the docking station; [0043] FIG. 19 is a view similar to FIG. 18 but with the hydrant valve shown in a valve open position; [0044] FIG. 20 is a view similar to FIG. 14 but showing the docking station disengaged and moving away from the hydrant; [0045] FIG. 21 is a schematic diagram of the control systems for the linear-move machine and docking station; [0046] FIG. 22 is an overhead schematic illustrating a sprinkling pattern achieved when the docking station is centrally located along the side beam fixed to the end tower of the linear-move machine; [0047] FIG. 23 is a view similar to that shown in FIG. 22 , but with the docking station moved toward a forward end of the side beam attached to the linear-move machine; [0048] FIG. 24 is a view similar to FIGS. 22 and 23 , but with the docking station located at a rearward end of the side beam attached to the linear-move machine; [0049] FIG. 25 is an overhead illustrating the different sprinkler patterns that are achievable with the docking station located in the positions shown in FIGS. 22, 23 and 24 ; [0050] FIG. 26 is a flow chart illustrating the control sequence for the linear-move machine and docking station in a start/stop mode of operation; [0051] FIG. 27 is a partial elevation of a linear-move machine incorporating a docking station in accordance with another exemplary embodiment of the invention; [0052] FIG. 28 is a partial perspective view of the linear-move machine shown in FIG. 27 ; [0053] FIG. 29 is a front elevation of the linear-move machine shown in FIG. 27 ; [0054] FIG. 30 is an enlarged detail taken from FIG. 28 ; [0055] FIG. 31 is an enlarged detail taken from the opposite end of the machine shown in FIG. 29 ; [0056] FIG. 32 is a partial side elevation similar to FIG. 27 , but with the telescoping arm and docking station moved to an extended rearward position; and [0057] FIG. 33 is a schematic drawing of a continuous docking configuration in accordance with another embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION [0058] With reference initially to FIG. 1 , a typical linear-move irrigation machine 10 includes a main truss assembly 12 supported by several wheeled towers 14 for movement in a forward direction along a linear path P 1 , or in a rearward direction along an opposite path P 2 . These paths extend perpendicularly to the truss assembly 12 , and parallel to a water supply pipe 26 . A drive tower 16 typically supports a generator (not shown) for supplying power to the drive wheels 18 . In an end-feed arrangement, the drive tower is located at one end of the field, and the supply pipe 26 runs along that end of the field. In a center-feed machine, the drive tower is typically located in the center of the field and the supply pipe also runs through the center of the field. Separate electric motors (also not shown) are often attached to the remaining towers 14 for driving the respective wheel pairs 20 as needed to maintain alignment with the end tower 16 and associated drive wheels 18 . Other drive arrangements including the utilization of battery power and/or electric drive motors connected to a power source by a cable could be employed. [0059] Guide booms 22 , 24 extend in opposite directions from the end tower 16 (parallel to the paths P 1 and P 2 ), and are engaged in a guide furrow F adjacent and parallel to the supply pipe 26 to thereby guide and maintain the machine in the desired path. Typically, if the guide booms stray laterally from the furrow beyond a predetermined limit, the machine will shut down. Other guide arrangements including the use of electronic and/or optical sensors, wire, GPS, etc. may be utilized as well. [0060] The water supply pipe 26 is fitted with spaced hydrants 28 that supply water to the machine 10 for distribution through a distribution pipe 27 (see FIGS. 4 and 5 ) on the truss assembly and ultimately to the sprinklers (one shown at 29 in FIG. 5 ) suspended from the boom assembly 12 , at spaced locations therealong. The supply pipe 26 is shown above ground, but may be underground, with only the hydrants 28 visible. The linear-move machine 10 as described is generally well-known, and this invention relates primarily to the manner in which the linear-move machine 10 engages and disengages the hydrants 28 . [0061] In connection with the further description of the docking station and related hardware, the various drawing figures have been simplified via omission of details for the sake of clarity and ease of understanding. For example, in some views, certain structure not necessary for understanding the text relating to these views has been omitted. In addition, wiring and other minor details that would otherwise clutter the drawings, but that are nevertheless well understood by those of ordinary skill in the art, have also been omitted from various figures. [0062] In an exemplary embodiment, and with specific reference to FIGS. 2 through 7 , a rigid side beam 30 is bolted or welded (or otherwise suitably secured) to an existing frame 32 of the drive tower 16 , such that the beam extends substantially parallel to the water supply pipe 26 , and to the direction of movement of the linear-move machine. Side beam 30 may be, for example, a solid or hollow box-beam, but in any event, the beam is provided with inverted V-shaped rails 34 , 36 (best seen in FIGS. 3, 4 and 5 ) along upper and lower edges of the beam, running substantially the entire length of the beam. [0063] A docking station assembly in accordance with one embodiment of the invention, includes a trolley, a supporting frame and the docking station itself. The trolley 38 includes a pair of metal plates 40 , 42 connected by a pair of, e.g., 2 in. dia. pipes 44 , 46 (or other suitably rigid members) extending laterally away from the side beam 30 . The larger plate 40 is located adjacent the side beam, and mounts an upper pair of rollers 48 , 50 and a lower pair of rollers 52 , 54 ( FIGS. 5 and 6 ) that permit the trolley 38 to roll along the rails 34 , 36 of the side beam 30 to any desired location along the length of the side beam. Simple pins or bolts (not shown) in combination with holes in the beam (or any other suitable mechanical, hydraulic, pneumatic or electric locking device), provide a reliable locking arrangement for securing the trolley, and hence the docking station, at desired locations along the side beam 30 . [0064] With reference especially to FIGS. 3, 6 , 7 , 11 and 12 , the docking station supporting frame 56 is carried on the trolley 38 and includes a pair of inverted U-shaped subassemblies 58 , 60 that are connected at their upper ends by frame members 62 , 64 ( FIGS. 3 and 5 ) and two pairs of roller mounting flanges 66 , 68 ( FIGS. 3, 6 , 7 and 12 ), each flange pair mounting two rollers 70 such that the supporting frame 56 is movable laterally, in a direction perpendicular to the paths P 1 and P 2 ( FIG. 1 ), along the trolley pipes or rails 44 , 46 between plates 40 , 42 . This arrangement provides a lateral adjustment feature for the docking station 76 relative to the side beam 30 as described further herein. As best seen in FIGS. 7, 11 and 12 , a pair of horizontally oriented coil springs 71 , 73 are connected between the outer plate 40 and the inner U-shaped subassembly 60 , while a second pair of horizontally-oriented coil springs 75 , 77 extend between the inner plate 42 and the outer U-shaped subassembly 58 . This arrangement maintains the docking station 76 (described below) in a generally centered position along the trolley rails 44 , 46 (between plates 40 and 42 ), but also permits reciprocatory spring-biased movement of the docking station 76 in opposite directions along the rails. Thus, the docking station 76 is able to accommodate various degrees of misalignment of any one or more of the hydrants 28 . Lateral movement of the docking station 76 to enable capture of a misaligned hydrant is also enabled by front and rear pairs of substantially vertical guide wings. Specifically, a forward pair of guide wings 72 , 74 is fixed to respective forward ends of subassemblies 58 , 60 and extend forwardly of the docking station 76 , flaring outwardly in the forward direction. A rearward pair of guide wings 78 , 80 is fixed to respective rearward ends of subassemblies 58 , 60 and extend rearwardly of the docking station 76 , also flaring outwardly but in the rearward direction. The role played by the guide wings 72 , 74 and 78 , 80 in assisting the capture of the hydrant flange is explained further below. [0065] The docking station itself, indicated at 76 , includes a pair of housings 82 , 84 (one shown in FIGS. 8, 9 ) on either side of, i.e., sandwiched about, a hydrant valve actuator assembly 86 ( FIG. 10 ). Since the housings 82 , 84 are identical to one another, only one need be described in detail. As best seen in FIG. 8 (exterior side) and FIG. 9 (interior side), housing 82 includes a main body portion 85 with two pairs of oppositely directed flanges 88 , 90 and 92 , 94 , each flange pair supporting between them a respective generally hourglass-shaped V-track roller 96 , 98 for rotation about a vertical axis defined by pivot pins or bolts 100 , 102 . The main body portion 85 of housing 82 also supports two pair of vertically aligned guide wheels 104 , 106 and 108 , 110 for rotation about horizontal axes indicated by bolt or pivot pin holes 112 , 114 , 116 and 118 , respectively. The pairs of guide wheels are supported axially between the V-track rollers 96 , 98 , on the inner side of the housing 82 . An additional pair of idler rollers 119 , 121 may be mounted on each housing, but they are merely optional, not required. An open channel member 97 is fixed to the inner side of the housing 82 , vertically centered between the guide wheels 104 , 106 , 108 and 110 . The open side of the channel faces inwardly, creating a slot that receives one side of the hydrant flange 122 . A vertically mounted side guide roller 99 is fixed to the housing and partially protrudes through an aperture 101 in the housing for engagement with the flange 122 . Thus, when housings 82 , 84 are assembled on either side of the valve actuator assembly 86 , a passageway or docking space 120 is defined by the two laterally opposed pairs of V-track rollers 96 , 98 at the front and back of the docking station, the channel members 97 and the two pairs of laterally opposed guide wheels ( 104 , 106 ) and ( 108 , 110 ) located axially between the two pairs of V-track rollers on each housing 82 , 84 . This passageway 120 (best seen in FIGS. 5 and 15 ) is located below the hydrant valve actuator 86 , and is sized and shaped to receive the flange 122 ( FIGS. 1, 14 , 15 and 17 - 20 ) on the hydrant 28 as also described further below. [0066] Also fixed to the housings 82 , 84 are a pair of substantially horizontally-oriented guide wings 124 , 126 ( FIGS. 2, 3 , 5 , 6 and 7 ). The guide wings 124 and 126 are secured to the housings 82 , 84 by means of bolts, welding or any other suitable means. Wing 124 projects outwardly and upwardly in a forward direction, while wing 126 projects outwardly and upwardly in a rearward direction. These wings work in concert with guide wings 72 , 74 and 78 , 80 to align the docking station 76 with the hydrants 28 . The vertically-oriented wing pairs 72 , 74 and 78 , 80 are designed to be engaged by the hydrant flange 122 when the hydrant is misaligned in a lateral direction, causing the docking station 76 to move laterally along the trolley rails 44 , 46 in a direction dependent upon which of the guide wings is engaged. The horizontally-oriented wings 124 , 126 are especially designed to assist in adjustment of the docking station 76 to a hydrant 28 that is slightly higher than a desired optimum height, i.e., when the flange 122 is higher than the passageway or docking space 120 . Thus, when wing 124 , for example, engages a hydrant flange 122 , it will cause the docking station to crawl upwardly over the flange 122 so that the flange can be engaged by one or more of the V-track rollers 96 , 98 . The V-track rollers 96 , 98 will also cam the docking station 76 in a direction that brings the docking station to a position where the flange 122 is located in the center of the V-track rollers 96 , 98 as best seen in FIGS. 13-15 . Note that the profile at the narrow center of the V-track rollers 96 , 98 complement the rounded profile of the peripheral edge of the flange. [0067] With reference especially to FIGS. 13-16 , the housings 82 , 84 and valve actuator assembly 86 of the docking station 76 also support a pair of dock stops 128 , 130 on the forward and rearward ends, respectively, of the docking station. The rearward stop 130 is controlled by a similar linkage and actuator arrangement as forward stop 128 , but is supported on the opposite side of the docking station 76 . Note that the forward and rearward stops and their associated linkage and drives are identical, with an actuator 166 mounted on each side of the docking station 76 , i.e., one actuator 166 is mounted on the housing 82 and the other actuator 166 is mounted on the housing 84 . For convenience and clarity, and with the exception of stops 128 , 130 , the links, shafts and bearing supports for each stop have the same respective reference numerals. Thus, the description of stop 128 below applies equally as well to stop 130 . In addition, note that the direction of movement in FIG. 13 is reversed in FIG. 14 to enable a clear illustration of the stops 128 and 130 in both retracted and extended positions. Note also that in FIGS. 13, 14 and 20 , one of the open channel members 97 (nearest the viewer) has been omitted to more clearly show the flange 122 within the opposite channel member. [0068] The forward stop 128 is in the form of a vertically-oriented bar combined with a horizontally-oriented proximity sensor 132 at its lower end. The proximity sensor for stop 130 is indicated at 131 . The stop 128 is pivotally supported by two sets of parallel links 134 , 134 ′ and 136 , 136 ′. The upper set 134 , 134 ′ is pivotally attached at a forward end to the upper end of stop 128 via a pivot pin, and at a rearward end to end 138 of a shaft 140 . The lower set of links 136 , 136 ′ is pivotally attached at a forward end to the lower end of the stop 128 and at a rearward end to a clevis 142 ( FIG. 10 ) secured to the lower housing 196 of the valve actuator assembly 86 . In this regard, the pivot pin or bolt (not shown) extends through holes 137 , 137 ′ in the clevis. This parallel linkage arrangement allows the stop 128 to move essentially vertically up and down between raised (go) and lowered (stop) positions upon rotation of shaft 140 , as shown, respectively, in FIGS. 13 and 14 . [0069] Shaft 140 is supported within a journal bearing 141 in an extended side 144 of the clevis 142 , and in a bearing stand 146 on the housing 82 . The free end of the shaft 140 adjacent the stand 146 mounts a clevis 148 for pivoting movement upon rotation of the shaft. A forward end of an adjustable link arm 150 is pivotally mounted within the free end of the clevis 148 . The rearward end of the link arm 150 is pinned to a forward end of a second link arm 152 via pin 154 ( FIGS. 14 and 17 ). The rearward end of the second link arm 152 is pivotally mounted in a clevis 156 (via pin 158 ) also supported on the housing. Adjacent the forward end of the second link arm (i.e., adjacent pin 154 ), a right angle arm 160 ( FIG. 14 ) is pivotally attached to a rigid connecting link 162 fixed to an output shaft 164 of one of the hydraulic actuators 166 . When the shaft 164 is extended, link 152 will pivot in a counter-clockwise direction, thereby pulling the first link 150 upwardly and rearwardly. This movement causes the clevis 148 and thus shaft 140 to rotate in a counter-clockwise direction. As a result, the parallel linkage comprised of link sets 134 , 134 ′ and 136 , 136 ′ will also rotate in the same direction, raising the stop 128 (or 130 ) to a retracted or “go” position. Retraction of actuator shaft 164 will have the opposite effect, i.e., lowering the stop 128 (or stop 130 ) to an extended or “stop” position. [0070] The docking station 76 itself is suspended or hung from the supporting frame 56 so as to allow the docking station to “float” to a limited extent in essentially any direction to facilitate capture of the hydrant. Specifically, and with reference again to FIGS. 4-6 , the docking station 76 is resiliently suspended from its supporting frame 56 by means of four coil springs (three shown at 168 , 170 and 172 in FIGS. 4-6 ) extending vertically between eyebolts (or other suitable points of attachment) secured to the inside surfaces of the horizontal members 174 of the inverted U-shaped subassemblies 58 , 60 and eyebolts (or similar) 176 on respective upper surfaces of housings 82 and 84 . In the exemplary embodiment, one pair of springs is attached to the top of housing 82 , and the other pair of springs is attached to the top of housing 84 , such that the four coil springs are arranged in a generally rectangular pattern. These springs permit spring-biased up and down movement of the docking station, and also permit limited side-to-side, front-to-back, and compound movements, i.e., tilting and twisting movements. [0071] A first pair of spring-loaded, compressible tie rods 178 , 180 ( FIG. 6 ) is secured substantially horizontally between the rearward vertical member 182 of the U-frame subassembly 58 , and the housing 82 via mounting bushings 184 , 186 (see also FIG. 9 ) and 188 , 190 , while a second pair of similar tie rods (one shown at 179 ) is secured in a similar orientation between the rearward vertical member 192 ( FIG. 3 ) of the other U-frame subassembly 60 and housing 84 , utilizing similar bushings (not shown). For each tie rod, and as best seen in FIG. 6 , a “piston” 194 is movable within the tie rod against a bias established by an internal spring. Such tie rods are well-known to those skilled in the art. The use of swivel mountings or universal bushings 184 , 186 and 188 , 190 with the tie rods, permits some degree of side-by-side, up and down and compound movements, in concert with the vertically-oriented springs 168 , 170 , 172 and 174 . Note also that the compressible tie rods also serve as shock absorbers in that they accommodate a limited degree of “over travel” by the linear-move machine during docking. [0072] With this arrangement, the docking station 76 “floats” relative to its supporting frame 56 for movement in at least three mutually perpendicular directions, i.e., vertical, horizontal front-to-back (and vice versa), and horizontal side-to-side. In addition, limited compound movements, i.e., tilting, swiveling and combinations thereof, are also possible by reason of the flexible nature of the vertically-oriented springs in combination with the tie-rod universal mounting arrangements. These multiple degrees of freedom of movement, in combination with the lateral adjustment enabled by the trolley 38 , permit reliable and accurate docking with hydrants 28 even when the latter are out of alignment relative to the docking station. [0073] The hydrant valve actuator assembly 86 ( FIG. 10 ) includes a lower housing 196 provided with a pair of attachment flanges 198 , 200 by which the valve actuator assembly 86 is secured between the housings 82 , 84 . Specifically, the valve actuator assembly 86 is attached to housing 82 via bolts extending through holes 214 , 216 in attachment flange 198 and holes 112 , 116 in guide wheels 104 , 108 that extend into the housing 82 . Dowel pins extending between holes 210 and 212 (provided in respective angled ribs or bosses 202 , 204 ) and holes 206 , 208 on attachment flange 198 may be used to align the attachment flange 198 with the housing 82 . Assembly 86 is attached to the other docking station housing 84 in a similar manner. [0074] The valve actuator assembly 86 also includes intermediate and upper housing portions 218 , 220 that, combined with lower housing 196 , enclose the valve actuator, as also described further below. A flexible hose 221 (see FIGS. 3-5 ) connects the actuator assembly 86 to the distribution pipe 27 of the truss assembly. [0075] With reference now to FIGS. 11 and 12 , an additional upper box frame 222 is mounted on the supporting frame 56 above the trolley rails 44 , 46 . This upper frame supports a pair of pressurized tanks or pressure accumulators 224 , 226 and a junction box 228 . Pressure accumulators 224 , 226 are used to supply water under pressure to the valve actuator 86 , and may be of any suitable design such as, for example, Teel Model No. 3P676C. External power may be supplied to the junction box 228 via cables 230 , 232 . A pair of batteries (for example, two 12-volt batteries, not shown but indicated as the power supply at 233 in FIG. 21 ) may also be supported on the drive tower of the linear-move machine 222 to provide supplemental power to the docking station PLC 336 and associated solenoids when the linear-move machine 10 is stopped and its own power generator shut off. This arrangement also utilizes the linear-move machine power generator to charge the batteries. As best seen in FIG. 12 , a solenoid bank is located below the junction box 228 and is supported on a cross member of the upper frame 222 . A plurality of solenoids 234 , 236 , 238 , 240 and 242 are supported below and connected electrically to the junction box 228 . The solenoids are also hydraulically connected to various controlled components. More specifically, solenoids 234 and 236 control the flow of water to and from the valve actuator 86 . Solenoids 238 and 240 control the movements of the dock stops 128 , 130 and solenoid 242 controls the main water control valve 357 . [0076] Turning now to FIGS. 18 and 19 , a hydrant or water supply valve 28 is shown extending upwardly from the supply pipe 26 . One or more riser footings 244 may be used to stabilize the hydrant. The hydrant includes a vertical riser 246 on which a valve housing 248 including the integral docking flange 122 is secured in telescoping relationship. The valve housing 248 encloses and supports a water supply valve assembly 250 in a generally vertical orientation. The valve housing 248 is formed with a lower opening 252 with an adjacent, interior shoulder 254 by which the housing 248 is supported on the upper edge 256 of the riser 246 . The manner in which the valve housing 248 is secured is within the skill of the art and may include threaded attachment, welding or other suitable means. [0077] The upper end of the housing 248 supports a valve cup 258 formed with an external shoulder 260 that permits the cup 258 to be seated on the valve housing 248 , with a smaller diameter lower portion 262 telescoped into the valve housing. A flexible annular seal 264 is seated in a groove formed in the interior of the cup. The valve assembly or simply “valve” 250 also includes an elongated stem assembly 266 with an annular Buna-Nitrile (or other suitable material) valve seal 268 sandwiched between upper and lower valve seal supports 270 , 272 . The lower support 272 is counterbored to create a spring recess 274 ( FIG. 19 ). A stem 276 is attached to the upper support 270 by threaded engagement of bolt 278 . The bolt 278 accesses the lower support 270 by means of a bore in the upper support 270 . The stem 276 extends downwardly and through a guide spider 280 fixed near the lower end of the valve housing. A pair of coil springs 282 , 284 extend between the spring recess 274 and the hub 286 of the guide spider 280 , thereby biasing the valve assembly 250 upwardly to a normally closed position, with valve seal 268 engaged with annular seat 288 at the lower end of cylinder 258 . The upper support 270 is also formed as a spider, with three radial webs 290 (2 partially shown) extending radially outwardly to the interior wall of the cylinder 258 , thus permitting flow out of the hydrant while also providing an engagement interface for the hydrant valve actuator piston/cylinder 302 as described further below. [0078] As already mentioned, the hydrant valve actuator 86 includes a three-part housing including the upper housing portion 220 , the intermediate housing portion 218 and the lower housing portion 196 , joined together at flanged interfaces 292 , 294 by bolts or other suitable means. Relatively large diameter portions of the upper and lower housing portions 220 , 196 in combination with the intermediate portion 218 create an enlarged interior chamber 296 axially between upper and lower smaller-diameter internal, cylindrical bores 298 , 300 . A unitary piston/cylinder 302 is slidable within the housing, with the piston or flanged portion 304 confined to movement within the enlarged chamber 296 . An upper cylindrical part 306 of the piston/cylinder 302 slides within the upper internal bore 298 while a lower cylindrical part 307 slides within the lower internal bore 300 . A first rolling diaphragm 308 is fixed between the upper end of the piston 304 and radial flanges 310 , 312 at the interface 292 between the upper and intermediate housing portions 220 , 218 . Similarly, a second rolling diaphragm 314 is fixed between the lower end of the piston 304 and the radial flanges 316 , 318 at the interface 294 between the intermediate and lower housing portions 218 , 196 . This arrangement creates an “extend” cavity 320 above the diaphragm 308 and a “retract” cavity 322 below the diaphragm 314 for fluid acting on opposite sides of the piston 304 . Fluid seals (O-rings or the like) 324 , 326 are located in respective upper and lower housing portions 220 , 196 to prevent fluid leakage from chamber 296 along the internal bores 298 , 300 . A spring 328 is located between an interior shoulder 330 at the lower end of the lower housing section 196 (formed by a counterbore in the lower internal bore 300 ) and the lower side of the piston 304 to normally bias the piston-cylinder 304 in an upward direction, to the retracted position shown in FIG. 18 . A first port 332 is provided in the upper portion of the housing for introduction/exhaustion of fluid into or from the extend cavity 320 and a second port 334 is provided in the lower housing section 196 for introducing/exhausting fluid into or from the retract cavity 322 . The operation of the hydrant valve actuator 86 will be described further below. [0079] Before describing the operation of the docking station, a brief description of the docking station control arrangement is in order. With reference to FIG. 21 , the PLC 336 is located within a panel box on the drive tower 16 . The PLC 336 and associated power supply 233 (two 12-volt batteries) connect to the controller 338 including PLC 340 , for the linear-move machine by means of an interface connector 342 . The controller 340 may be a conventional control module for a linear-move machine with no modification required to interact with the PLC 336 for the docking station. The PLC 336 includes a pre-programmed configuration set-up 344 and receives various user commands from a user interface from an input panel 346 accessible by opening the front face of panel box 228 . The PLC 336 also receives input from the water pressure switch 348 , dock stop proximity switches 350 in the proximity sensors 131 and 132 , and a valve actuator cylinder proximity switch 352 . The PLC 336 provides output commands to the solenoids 234 , 236 , 238 , 240 and 242 . [0080] The safety mechanisms on the docking module and linear-move machine are also coordinated through the interface connector 342 . The PLC 340 of the linear-move controller 338 communicates with the PLC 336 of the docking station 76 by means of respective interface relays 340 , 342 . In short, the controls for the docking station 76 are integrated into the controller 338 for the linear-move machine 10 , with no modification required to the controller 338 . While the PLC and associated solenoids may be powered by the linear-move machine engine generator while the linear-move machine 10 is moving, it is preferred to also utilize battery power (e.g., a pair of 12-volt batteries (indicated by reference numeral 233 in FIG. 21 ) as supplemental power for the docking station 76 when the linear-move machine 10 is shut down during valve actuation and sprinkling. [0081] The linear-move machine 10 and associated docking station 76 may be programmed to operate in at least five different modes: (1) simple start/stop irrigation; (2) start/stop with manual offset of the docking station 76 ; (3) start/stop with automatic offset of the docking station 76 ; (4) start/stop with one docking station 76 and substantially continuous machine movement; and (5) continuous linear-move machine movement with two docking stations 76 . [0082] (1) Simple Start/Stop [0083] In this mode, the docking station 76 is initially located at any desired location along the side beam 30 and locked in place. Generally, for this mode of operation, the docking station 76 will remain in this position throughout the irrigation cycle. With reference to FIG. 22 , when the docking station 76 is located approximately midway along the side beam 30 , a circular sprinkling pattern 356 will be generated by any one of the sprinklers 29 on the truss assembly 12 . [0084] FIG. 23 illustrates a circular pattern 358 generated when the docking station 76 is located at the forward end of the side beam 30 , and FIG. 24 illustrates a third circular pattern 360 generated when the docking station 76 is located at the rearward end of the side beam 30 . FIG. 25 shows the positions of patterns 356 , 358 and 360 relative to the truss assembly 12 and drive wheels 18 for appreciation of how the sprinkling pattern locations can be manipulated via location of the docking station 76 along the side beam 30 to achieve greater wetting uniformity in the irrigation cycle. [0085] As the linear-move machine 10 is driven forward in the direction of path P 1 ( FIG. 1 ), the dock stop 128 (forward) is in the up or go position, while the rearward dock stop 130 is in the lowered or stop position ( FIG. 13 ). [0086] As the linear-move machine 10 continues to move in a forward direction, the hydrant flange 122 and docking station 76 are initially roughly aligned, if necessary, by the interaction of the flange 122 with the side guide wings 72 , 74 and front guide wing 124 . Assuming the hydrant flange 122 and docking station 76 are not in substantial alignment during the initial contact, the vertically-oriented front guide wings 72 , 74 (and/or the horizontally-oriented forward guide wing 124 ) will be engaged by the stationary hydrant flange 122 , causing the docking station 76 to move laterally along the trolley rails 44 , 46 to an aligned position, while engagement with wing 124 will cause the docking station to move upwardly as the docking station continues to move toward the hydrant. The flange 122 will then be engaged by the forward pair of V-track rollers 96 , the tapered surfaces of which further center the flange 122 relative to the docking station so that the flange is located at the smallest-diameter portion of the V-track rollers, as best seen in FIG. 15 . In other words, the V-shape of the spinning rollers 96 allows the free-floating docking station 76 to crawl around the hydrant flange 122 until they are aligned. The hydrant flange 122 then slides between guide wheels 104 , 106 and into the side guide channel members 97 which capture the hydrant flange in the same plane as the docking station. [0087] In an alternative arrangement, a power-assist feature may be added to facilitate lateral movement of the docking station on the trolley 38 upon engagement of the hydrant flange 122 with one or the other of guide wings 72 , 74 . This would function similar to power brakes or power steering in a vehicle, and could employ oil hydraulics, water hydraulics, pneumatics, or electric motors to move the docking station along the trolley rails 44 , 46 . [0088] As the hydrant flange 122 is captured by the docking station 76 , the linear-move machine 10 continues forward travel until the hydrant flange 122 touches the rearward docking stop 130 . More specifically, when the docking stop proximity switch 132 (part of the stop) is tripped (for example, when the flange 122 is within a few millimeters of the stop), it signals the PLC in the control panel to stop the forward movement of the linear-move machine. At this point, the linear-move machine “coasts” into engagement with the docking stop 130 . The hydrant flange 122 is now fully captured by the docking station 76 , and the linear-move machine is in position to connect to the water supply valve. Depending on the normal operating speed of the linear-move machine, a second proximity switch may be used “upstream” of the switch 132 for the purpose of effecting a reduction in speed of the linear-move machine as it approaches the hydrant. [0089] When the docking station is fully aligned with the hydrant water supply valve, only the flange 122 is engaged with the docking station. In other words, the docking station self-aligns with the flange 122 , the alignment determined by the dock stop 130 , the laterally opposed and axially spaced pairs of guide wheels 104 , 106 and 108 , 110 , and the opposed, horizontally-oriented channel members 97 and associated side-guide wheels 99 on the interior sides of the housings 82 and 84 . Note that in the fully aligned position, the flange is located between and axially spaced from the forward and rearward V-track rollers. [0090] The PLC 336 now sends a command to port water from the pressure accumulators 224 and 226 (they are connected in parallel) through the extend on/off control solenoid valve 234 to the extend diaphragm cavity 320 in the actuator assembly 86 . At the same time, the same solenoid vents water in the retract cavity 322 . The water force in the extend cavity 320 overcomes the force of spring 328 and pushes the lower cylinder portion 307 down into the hydrant valve housing 248 . The cylinder 307 eventually travels through the valve cup 258 , and as the cylinder continues its downward movement, the valve seal 268 is pushed off the valve seat 288 to thereby open the valve. After extend on/off control solenoid 234 has been signaled by the PLC, a time delay allows sufficient time for system water pressure to recharge both pressure accumulator tanks 224 , 226 (as needed). After the time delay, the PLC 336 sends a command to solenoid 242 to open the control valve 357 located where the hose 221 joins the water distribution pipe 27 so that water is then free to flow via the valve through the piston-cylinder 302 through the distribution pipe supported on the truss assembly 12 and to the sprinklers 29 . [0091] After the sprinklers have run for the programmed amount of time, the PLC 336 sends a command to solenoid 242 to close the control valve 357 to prevent water from draining out of the linear-move machine 10 , via pipe 27 . The PLC 336 then sends a command to vent water from the “extend” cavity 320 through the main water extend on/off control solenoid valve 234 to atmosphere. This removes the downward force on the rolling diaphragm 308 . At the same time, the PLC 336 sends a command to port water to the “retract” cavity 322 through the main water retract on/off control solenoid valve 236 . The spring 328 and diaphragm 314 now push the piston-cylinder 302 back up into the actuator housing to the position shown in FIG. 18 . As the piston-cylinder 302 retracts, the valve seal assembly 250 is pushed upward by the valve springs 282 , 284 until the valve seal 268 seats on the valve seat 288 and shuts off water flow. When a proximity switch 352 senses the actuator cylinder 307 is retracted, the PLC 336 initiates forward movement of the linear-move machine 10 to the next hydrant. To initiate such forward movement, water is first ported through the solenoid 240 that operates hydraulic actuator 166 . The hydraulic actuator 166 extends its output shaft 164 to thereby raise the stop 130 out of the path of the flange 122 to the retracted or “go” position. The linear-move machine 10 then begins to drive forward to the next hydrant. When the docking station is disengaged from the hydrant flange, the springs 71 , 73 and 75 , 77 will return the docking station to its centered position along trolley rails 44 , 46 . Following a programmed time delay to ensure that the docking station 76 has cleared the hydrant, the PLC sends a command to solenoid 240 to port water from the hydraulic actuator 166 to atmosphere. The hydraulic actuator rod 164 is forced to retract by an internal spring, rotating the dock stop 130 to its extended or “stop” position. The dock stop 130 is now in position to stop the docking station at the next hydrant. It will be appreciated that dock stop 128 will operate in the same manner when the linear-move machine travels in the opposite direction. Thus, stop 128 is always retracted when the linear-move machine travels along path P 1 , and stop 130 is always in the retracted position when the machine travels along path P 2 . [0092] In this example, water from the irrigation pipes is used as a hydraulic drive fluid. A closed hydraulic system employing standard hydraulic fluids, a pump, reservoir, and filter could also be employed. A water glycol fluid is currently under consideration. A pneumatic system could also be used employing a compressor, filter and reservoir. An electric jack screw or actuator could also connect to the valve actuator 86 and be used to drive it up and down into the hydrant valve 28 . [0093] The hydraulic control lines that feed the “extend” and “retract” cavities on the valve actuator assembly 86 can have in-line orifices to provide flow rate control in and out of their respective cavities. This will control how fast the valve will turn on and off. By controlling valve opening and closing speed, water hammer will be kept to a minimum. [0094] A simple flow chart illustrating operation in this mode is shown in FIG. 26 . Initially, the system checks to see that all safety criteria have been met. If not, the machine will stop. Similarly, when the linear-move machine is wired to the docking station module, operation is in an “auto” mode. If “manual” is chosen or indicated, the machine will stop. The remaining events are in a simple logic loop form, depending on the direction of movement of the machine. [0095] (2) Start/Stop with Manual Offset [0096] This mode is essentially identical to the mode described above, but with the option of manually offsetting the docking station 76 for the next set of moves, for example, from the position shown in FIG. 22 to the position shown in FIG. 23 . This would improve the overall systems water distribution efficiency over the course of many applications of water. Offsetting the docking station 76 is accomplished easily by manually moving the trolley 38 along the rail or side beam 30 and pinning it in its new desired position. Otherwise, the operation is as described above for the first mode. [0097] (3) Start/Stop with Automatic Offset [0098] This mode is essentially identical to mode (2) but with an automatic offsetting feature, controlled by the PLC 336 . This would allow the linear-move machine 10 to move down the field along path P 1 in a first run with the docking station 76 fixed in the position shown, for example, in FIG. 21 . The PLC would send a command to automatically apply an offset (as shown in, for example, FIG. 23 ) at the end of the field, and then return back in a second run along path P 2 , applying water in a pattern 358 offset from the first pattern 356 . The automatic movement of the docking station 76 along side beam 30 can be achieved by any suitable mechanical, electromechanical, hydraulic, pneumatic or other drive means in concert with appropriate programming of the PLC 336 as would be well understood by those skilled in the art. [0099] (4) Start/Stop Semi-Continuous Mode [0100] With reference to FIGS. 27-32 , for this start/stop continuous mode, the support structure for the docking station is modified to include a second beam 362 (also referred to as the “telescoping arm”) movable along the side beam 30 . The rigid, stationary side beam 30 remains fixed to the drive tower 16 as described above. In this embodiment, however, the side beam mounts plural roller brackets 364 (three in the exemplary embodiment). Each roller bracket includes a vertically-oriented plate 366 fixed to the side beam 30 at axially spaced intervals, for example, one adjacent each of the forward and rearward ends of the side beam 30 , and one intermediate the ends. As best seen in FIG. 32 , each plate 366 supports a first upper pair of rollers 368 mounted for rotation at opposite ends of a roller support rod 370 fixed to the plate 366 by an axially centered pin or bolt 372 . A lower pair of rollers 374 is identically mounted but spaced laterally outwardly of the side beam by a spacer block 376 ( FIG. 29 ). [0101] The telescoping arm 362 is shown substantially square in cross section in the exemplary embodiment, but is not necessarily limited to that shape. The arm is provided with elongated rails 380 , 382 ( FIG. 29 ) running along the length of the telescoping arm. One rail 380 is located on the upper surface 384 of the telescoping arm 362 , adjacent the inner side (closest to the drive tower) thereof. The second rail 382 is located on the lower surface 386 of the telescoping arm, substantially centered thereon as apparent from FIG. 29 . The telescoping arm 362 is oriented such that upper rollers 368 on the roller brackets 364 engage the upper rail 380 while the lower rollers 374 engage the lower rail 382 . This arrangement permits the telescoping arm 362 to slide forwardly and rearwardly along the fixed side beam 30 between rearward-extended and forward-extended positions. At the same time, the docking station 76 and its supporting trolley 38 are movable to desired locations along the telescoping arm 362 via upper and lower pairs of rollers 388 , 390 engaged on additional upper and lower rails 392 , 394 fixed to the upper and lower surfaces of the telescoping arm, adjacent the outer side wall 396 . The mounting of the docking station 76 to the telescoping arm 362 is substantially identical to the manner in which the docking station is supported on the side beam 30 in the earlier-described embodiments. [0102] In the exemplary embodiment, the telescoping arm 362 is moved along the fixed side beam 30 by means of a chain drive. Specifically, a group of three sprockets 390 , 400 , 402 , best seen in FIG. 30 , is located at one end of the arm, supported on the lower inner surface 404 for rotation about vertical axes. The middle sprocket 400 serves as a tensioner in that it can be adjusted axially along a slot in the bracket 406 to adjust the chain tension in conventional fashion. [0103] The opposite end of the lower surface of the telescoping arm is fitted with a pair of sprockets 408 , 410 , shown in FIG. 31 . Sprocket 408 is an idler sprocket while sprocket 410 is a drive sprocket, attached to a vertically oriented drive shaft 412 . A first drive chain 414 extends between one side of the docking station trolley plate 40 , around the three sprockets 398 , 400 , 402 and along the telescoping arm 362 to an attachment point on one side of roller support bracket 364 in the middle of the fixed side beam 30 . A second drive chain 416 extends between the opposite side of the docking station trolley plate 40 , around the two sprockets 410 , 408 and along the telescoping arm 362 to an attachment point on the other side of the middle roller support bracket 364 . Accordingly, rotation of the drive shaft 412 in a clockwise direction will cause the telescoping arm 362 to move to the left (relative to the fixed beam) as viewed in FIG. 27 while rotation in a clockwise direction will cause the telescoping arm 362 to move to the right. Shaft 412 is connected to a suitable motor and clutch arrangement under the control of the docking station PLC. [0104] More specifically, a neutral position exists when the docking station 76 mounted on the telescoping arm 362 is centered along the length thereof, and when the telescoping arm 362 is itself aligned with and adjacent the fixed beam 30 as shown in FIG. 27 . Rotating the drive shaft 412 in a counterclockwise direction pulls the telescoping arm 362 forwardly relative to the fixed side beam 30 , while at the same time, moving the docking station 76 to the front of the telescoping arm 362 . This is the position assumed when the first hydrant 28 is engaged at commencement of travel of the linear-move machine 10 along the path P 1 . In other words, the first hydrant 28 engaged by the docking station 76 is forward of the drive tower 16 , i.e., with the telescoping arm 362 extended forwardly to its maximum extent, and the docking station 76 at its forwardmost position on the telescoping arm. With the first hydrant fully engaged and with the hydrant valve open, the linear-move machine 10 begins moving forward. As it does so, the telescoping arm 362 retracts relative to the fixed beam 30 and the linear-move machine. As the linear-move machine continues its forward progress, the telescoping arm 362 continues to retract relative to the fixed side beam 30 and eventually extends rearwardly of the machine. When the telescoping arm 362 approaches its rearwardmost extended position, and with the docking station 76 now at the rearward end of the telescoping arm, as shown in FIG. 32 , the linear-move machine is halted. The docking station is de-coupled from the first hydrant 26 and the telescoping arm 362 is then again moved forwardly so as to extend beyond the fixed beam 30 and into position for coupling with the next (or second) hydrant. During this movement, the chain drive also moves the docking station 76 from the rearward end to the forward end of the telescoping arm. The docking station 76 is then coupled to the second hydrant and the linear-move machine resumes movement along the path P 1 . This action is repeated as the linear-move machine moves from one end of the field to the other. [0105] Depending on economics, the telescoping arm 362 could be eliminated and the hydrants 28 along the water supply pipe 26 could be located closer to each other, i.e., with a spacing roughly equal to the travel distance of the docking station 76 along the fixed side beam 30 . [0106] In order to accommodate movement of the telescoping arm 362 along the fixed side beam 30 , and movement of the docking station 76 along the telescoping arm 362 , hose management hardware is required. In this embodiment, the flexible supply hose 414 connecting the valve actuator on the docking station 76 to the overhead truss assembly 12 , is permitted to seat on a plurality of V-rollers 416 mounted for rotation within an elongated channel member 418 fixed on the upper surface of the telescoping arm 362 . These rollers cooperate with a pair of considerably larger drum wheels 420 , 422 that are supported on the telescoping arm 362 directly above the rollers 416 . With the hose extending between rollers 416 and drum wheels 420 , 422 as shown in FIG. 27 , and then winding back across the tops of the drum wheels 420 , 422 , it will be appreciated that the hose 414 will move in a controlled manner, as the telescoping arm 362 moves between its extended rearward and extended forward positions, and as the docking station 76 moves simultaneously between rearward and forward positions on the telescoping arm. [0107] (5) Continuous Mode [0108] In this mode, two telescoping docking stations are employed. With reference to FIG. 33 , the linear-move machine 424 is fitted with inner and outer fixed beams 426 , 428 , respectively, that form a box-like frame 430 attached to the drive tower 16 by one or more connecting beams 432 , as appropriate. A first docking station 434 is mounted for movement along the inner fixed beam 426 , while a second docking station 436 is mounted for movement along the outer fixed beam 428 . The docking stations 434 and 436 are similar to docking station 76 , and the mounting of these docking stations and associated trolleys to the fixed beams 426 , 428 is also similar to the mounting of the docking station 76 to the beam 30 via trolley 38 . Here, however, the docking stations are driven along the respective beams by chain, cable, belt drive or other suitable means along with a motor and clutch arrangement. In addition, the hydrants 438 , 440 , 442 , etc. are offset from supply pipe 444 , in opposite directions, in alternating fashion. This arrangement allows the docking stations 434 and 436 to engage alternate hydrants on opposite sides of the supply pipe. To facilitate this movement, flexible hoses 446 , 448 connect the docking stations 434 , 436 to the water distribution pipe 450 on the overhead truss assembly. [0109] In operation, docking station 434 will engage hydrant 438 while docking station 436 is moved along fixed beam 428 to engage the next hydrant 440 on the opposite side of pipe 444 . After docking station 436 engages hydrant 440 , docking station 434 will disengage hydrant 438 and move forward along inner beam 426 to the next hydrant 442 as the linear-move machine also moves forward. During movement of the machine, it will be apparent that docking station 436 remains stationary relative to hydrant 440 while outer frame 430 moves forward with the machine. This arrangement permits continuous movement of the linear-move machine from one end of the field to the other, without having to stop for engagement with the hydrants along the water supply pipe. [0110] The above-described docking station configurations provide a reliable and relatively simple solution to the problems normally associated with linear-move machines that incorporate an automatic docking feature. [0111] While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

1a

FIELD OF THE INVENTION This invention generally pertains to medical instrument support apparatus and, more particularly, to instrument support mechanisms that are used to hold ophthalmic or optical instrumentation to allow easy movement between different positions relative to a patient. BACKGROUND OF THE INVENTION Many different types of instrument support mechanisms exist in the medical industry for supporting medical instrumentation in front of a patient. Often, the patient is seated in an examination chair. As examples, ophthalmic instruments such as slit lamps, indirect ophthalmometer and vision tester must be placed in front of a patient during eye examination procedures while the patient is seated in an examination chair. These instruments are typically placed on a movable table or on movable instrument support arms mounted adjacent the patient. Instrument support arms are generally attached to support poles forming part of an instrument stand. In some systems, two arms may be used with one arm supporting lighter weight instruments and the other arm supporting heavier weight instruments. Heavier weight instrumentation may also be supported on the movable tables mentioned above. Support mechanisms that have taken the form of arms which move with multiple degrees of freedom. A typical support mechanism may, for example, rotate about the support pole and move up and down along the support pole. The mechanism may also have a first arm which adjusts vertically using a pivotal motion and have a second arm at an outer end which is pivotally connected to the first arm. Additional arms or support structure may be connected to the arms. Each of the above described movements should be lockable such that a practician may set the mechanism and, therefore, the attached instrumentation in the desired location relative to the patient. Certain instrument arms are not lockable, however, this is not desirable in many situations. Most arms in the past have required at least two separate lock mechanisms and two separate manually operated levers or knobs to lock and unlock the various pivot connections of the mechanism. This makes locking and unlocking the mechanism cumbersome and often difficult for the practician. One known type of instrument support mechanism does include a single lever for locking and unlocking the three main pivoting movements described above. However, this lever must be rotated generally in a direction perpendicular to the mechanism. Therefore, the practician must use two hands to hold the mechanism against rotation about the support pole while rotating the lever to lock the mechanism in place. The same holds true when unlocking the mechanism. Also, the levers and knobs as previously located on such mechanisms may not be easily accessed or actuated by the practician. For the reasons stated above as well as other reasons, it would be desirable to provide an adjustable medical instrument support mechanism, and especially a mechanism suitable for use in the ophthalmic area, in which a simplified and easily actuated locking mechanism is used and includes a single lever which may be actuated in a simple motion to either lock or unlock various pivot connections of the support mechanism. SUMMARY OF THE INVENTION The present invention therefore provides a medical instrument support mechanism which includes a unique locking mechanism allowing easier use by a practician. The mechanism is especially suitable for use in the ophthalmic or ophthalmologic industry but could be used in other medical areas as well. More specifically, the instrument support mechanism of this invention includes a base member which could be a stationary support, such as a pole, or a separate member connected to a pole. A first support arm is connected to the base member and a second support arm is connected to the first support arm. The first support arm is connected to the base member by a pivot connection at one end allowing the other end to be moved with respect to the first end. This movement preferably is a vertical, pivotal motion but could alternatively or additionally comprise a pivoting motion about the base member. The second arm is also preferably connected by a pivot connection to the first support arm to allow the second support arm to swing about an axis relative to the first support arm. In the preferred embodiment, the base member is connected to a vertical support pole for rotation about the pole and height adjustment along the pole. In accordance with the invention, a locking mechanism is uniquely connected to two or more pivot connections to allow an operator to selectively lock and unlock the pivot connections. More specifically, the locking mechanism is operated by a lever which is movable in a direction extending along the length of the first support arm. This helps ensure that pivoting motion does not occur while locking or unlocking the mechanism. More preferably, the lever is disposed along an underside of the first support arm and is operated by a simple push/pull movement. More specifically, the locking mechanisms of this invention are advantageously designed as unique screw locking mechanisms. Each screw locking mechanism locks and unlocks to at least one pivot connection by operating a clamp member associated therewith. The clamp members used in the present invention may be generally U-shaped clamp members that receive an element of the pivot connection. In the case of the vertically adjustable pivot connection, the screw clamps or unclamps linkage members associated with the vertically adjustable pivot connection. Also in accordance with the invention, the screws used in the screw locking mechanisms are preferably double helical threaded screws. While single lead screws will function, the use of double lead screws shortens the required travel of the actuating lever. In accordance with the preferred embodiment of this invention, heavy duty and light duty instrument support mechanisms are constructed in accordance with the invention. In a heavy duty version of a medical instrument support mechanism, for example, multiple counterbalancing springs may be used in place of a single counterbalancing spring and heavier duty and/or larger numbers of linkage members may be used to support the heavier instrumentation. In each case, the broader principles of this invention may be employed to achieve the advantages of the invention. These and other object and advantages of the invention will be more readily apparent to those of ordinary skill in the art upon review of the following detailed description of the preferred embodiments taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of an illustrative instrument stand showing the use of both heavy duty and light duty instrument support mechanisms of the present invention; FIG. 2 is a partially fragmented side elevational view of the heavy duty instrument support mechanism shown in FIG. 1 showing the mechanism in a locked position; FIG. 2A is a cross sectional view taken along line 2A--2A of FIG. 2; FIG. 3 is a cross sectional view taken along line 3--3 of FIG. 2; FIG. 4 is a cross sectional view taken along line 4--4 of FIG. 2; FIG. 5 is a diagrammatic view of the mechanism shown in FIG. 2 but illustrating an unlocked position; FIG. 6 is a partially fragmented side elevational view of the light duty instrument support mechanism shown in FIG. 1 showing the mechanism in a locked position; FIG. 7 is a cross sectional view taken along line 7--7 of FIG. 6; FIG. 8 is a cross sectional view taken along line 8--8 of FIG. 6; and FIG. 9 is a diagrammatic view of the mechanism shown in FIG. 6 but illustrating an unlocked position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 illustrates a typical ophthalmic instrument system showing one potential use for a heavy duty support mechanism 10 and a light duty support mechanism 11, each being constructed in accordance with principles of this invention. Mechanisms 10, 11 are shown affixed to one type of instrument stand 12, however, it will be understood that many other supports may be used for mechanisms 10 and 11, as shown in FIG. 1, or mechanisms taking other forms in accordance with the invention. Instrument stand 12 generally includes a base 14 which may hold a plurality of instruments 14a, 14b, 14c and which includes an upwardly extending pole 16. Pole 16 may have an overhead light 18 attached at the upper end. As further shown in dotted lines in FIG. 1, support mechanism 11 may carry a lighter weight ophthalmic instrument, such as a vision tester 17, while mechanism 11 may carry heavier weight structure such as a chin rest 19 and a slit lamp 21 or other instrument (not shown). Referring now to FIG. 2, instrument support mechanism 10, which is suitable for heavier duty applications, includes a first arm 20 and a second arm 22 pivotally connected together by means to be described below. A cover 20a is preferably used to conceal the internal components and conventional wiring (not shown) associated with arm 20. A similar cover may be used on arm 11 (FIG. 1) as mentioned below. First arm 20 comprises a first link member 24 and a second, lower link member 26. Link members 24, 26 are respectively affixed by pivots 28, 30 to a base member 31. These pivots 28, 30 allow the opposite end of arm 20 to be moved vertically with respect to base member 31. Referring briefly to FIG. 3, respective pairs of links 36a, 36b and 38a, 38b assist with the locking of arm 20 in a desired vertical orientation relative to base member 31. In this regard, links 36a, 36b and 38a, 38b are pivotally connected to first link member 24. One pivot 40 for securing one end of links 36a, 36b is shown in FIG. 2 with the understanding that a similar pivot connects links 38a, 38b to the same link member 24. As best shown in FIG. 3, the opposite ends of links 36a, 36b and 38a, 38b include respective slots 42a, 42b and 44a, 44b for reasons to be described below. Still referring to FIG. 2, along with the vertical pivoting movement allowed by the pivoting nature of link members 24, 26, first arm 20 may pivot about support pole 16 by a pivot connection 46 and second arm 22 may pivot with respect to both the first arm 20 and support pole 16 by a pivot connection 48. More specifically, pivot connection 46 is made by way of a tube 50 that may be rigidly locked to support pole 16 and which receives a portion of base member 31 thereabout. To act as a stop for pivoting motion about pole 16, a screw 52 is contained in base member 31 and extends into a slot 54 contained in tube 50. A conventional screw operated clamp mechanism 56 is used to secure tube 50 rigidly to pole 16. When lock 56 is in an unlocked position, tube 50 and the attached mechanism 10 may be height adjusted along support pole 16. At the opposite end of first arm 20, pivot connection 48 more specifically comprises a pivot support 58 which holds a pivot tube 60 for rotation therein. Pivot tube 60 is held for rotation within bearing members or low friction bushings 62, 64. A retaining ring 68 holds pivot tube 60 in place within pivot support 58. Retaining ring 68 rests against a washer 66 as shown in FIG. 2, to keep second arm 22 held in place within pivot support 58. Pivot tube 60 may also be used to accommodate wiring (not shown) to arm 22. Rotation of tube 60 and, therefore, arm 22 is limited by a screw 69 which engages a stop 71 at a desired limit of rotation. As further shown in FIG. 2 and 2A, counterbalancing springs 70a and 70b help to counterbalance any weight being supported on second arm 22, or on an additional arm attached thereto, in a generally conventional manner. Specifically, springs 70a and 70b are connected to an adjustment screw 72 to allow adjustment of the counterbalancing force. Ends 74a, 74b are each connected to a pin which includes an internally threaded bore receiving the adjustment screw 72. The opposite ends of springs 70a and 70b are connected to pivot pin 34. Still referring to FIG. 2, a locking mechanism 90 operates to lock each of the above described pivot connections in place after mechanism 10 has been adjusted vertically and rotationally to the desired orientation. Locking mechanism 90 is operated by a lever 92 which may be moved in a simple and short push or pull manner in a direction extending along the length of first support arm 20 as generally shown by arrow 94. Lever 92 is connected by a pivot 96 to link member 26 and is further connected to a connecting link 98 by a pin 100 extending from connecting link 98 and into a slot 102 contained in the end of lever 92. Connecting link 98 is pivotally attached at opposite ends to respective short links 104, 106 by respective pivots 108, 110. The opposite end of each short link 104, 106 is connected to rotate a respective screw 112, 114. As will be described below, these screws operate to simultaneously lock pivot connections 46 and 48 as well as the general pivot connection formed by pivots 28, 30, 32, 34 allowing arm 20 to move vertically with respect to base member 31. Referring now to FIG. 3, to lock pivot connection 48 in place, a clamp member 116 is provided around pivot tube 60. Thus, it will be appreciated that when clamp member 116 is tightened against pivot tube 60, pivot tube 60 will not be capable of rotating and, therefore, second arm 22 will not be capable of rotating with respect to first arm 20. As more specifically shown in FIG. 3, clamp member 116 includes a first portion 118 having an internally threaded insert 120 and a second portion 122 having a hole 124. Threaded insert 120 receives a threaded portion 112a of screw 112, while hole 124 receives an unthreaded portion 112b of screw 112 with clearance to allow rotation of screw 112. Preferably, the threaded portion 112a is a double helical thread. Most preferably, screws 112, 114 are 3/8"--10 double lead screws. Additional clamp members 126, 128 are provided for locking the above described vertical movement of first arm 20 with respect to base member 31 (FIG. 2). These clamp members 126, 128 each include flange portions 126a, 128a that serve to clamp links 36a, 36b and 38a, 38b against a portion of pivot support 58 to prevent any movement of links 36a, 36b and 38a, 38b and thereby prevent any vertical movement of first arm 20 with respect to base member 31 (FIG. 2). It will further be appreciated that in an unlocked state, tubular portions 126b, 128b act as guides that ride within slots 42a, 42b and 44a, 44b during the vertical movement of first arm 20 with respect to base member 31. The tubular portion 128b is preferably internally threaded and carries threaded member 130 to provide adjustment capability and a force bearing surface. Washers 134, 136 are located about tubular portion 126b and between pivot support 58 and link member 36b and link members 36a and 36b. Likewise, washers 138, 140 are located between pivot support 58 and link 38b and links 38a, 38b. Turning now to FIG. 4, pivot connection 46 more specifically comprises a clamp member 150 having a first portion 152 with a threaded insert 154 and a second portion 156 with a hole 158. In a manner similar to pivot connection 48, threaded insert 154 contains a double helically threaded portion 114a of screw 114 and hole 158 receives an unthreaded portion 114b of screw 114 with clearance to allow rotation of screw 114. Clamp member 150 is disposed about tube 50 and, therefore, when clamp member 150 is tightened, no rotation of base member 31 about tube 50 may take place. A set screw 159 allows adjustment in the clamping action. As further shown in both FIGS. 3 and 4, short links 104, 106 are rigidly connected to screws 112, 114 at intermediate locations thereon with retainer pins 160, 162. Thus, a review of FIGS. 2-4 will indicate that moving lever 92 away from base member 31 in the direction of arrow 94 will result in connecting member 98 moving toward base member 31 and short links 104, 106 rotating screws 112, 114 clockwise as viewed in FIG. 2. As shown in FIG. 3, this will cause screw 112 to move in the direction of arrow 163 to urge clamp member 126 against links 36a, 36b until they are wedged against washers 134, 136 and pivot support 58. This will lock up and down motion of first arm 20 with respect to base member 31 (FIG. 1). Simultaneously, clamp 116 will be rotated slightly around pivot tube 60 and move generally in the direction of arrows 164, 165. This will urge clamp member 128 against links 38a, 38b and clamp these links against washers 138, 140 and against pivot support 58 to further assist in locking vertical movement of arm 20. As clamp portion 118 moves further toward clamp portion 122, pivot tube 60 is locked against any rotational movement. As long as short links 104, 106 (FIG. 2) are maintained in the position shown, mechanism 10 will be locked completely in place by the friction of screws 112, 114. To unlock mechanism 90, lever 92 is moved in the direction of arrow 95 toward base member 31 (FIG. 5). This moves short links 104, 106 to an oppositely angled position and rotates screws 112, 114 counterclockwise to reverse and unlock the various clamping movements discussed above. Referring now to FIG. 6, the lighter duty instrument support mechanism 11 is shown in more detail. Mechanism 11 works on very similar principles to those discussed above with respect to mechanism 10. Mechanism 11 comprises a first arm 170 and second arm 172 which are pivotally connected to one another in a manner to be described below. First arm 170 may have a cover 170a (FIG. 7) to conceal internal components. First arm 170 is also pivotally connected to a base member 174 to allow vertical, pivoting movement with respect thereto as will also be described below. First arm 170 comprises a first link member 176 and a second link member 178. First and second link members 176, 178 are connected to base member 174 by respective pivots 180, 182 which allow vertical pivoting motion with respect to base member 174 in a vertical orientation as shown in FIG. 6, i.e., when support pole 16 extends in a vertical orientation. Links 188a, 188b are connected at a pivot 190 to first link member 176 as shown in FIG. 6. As further shown in FIG. 7, links 188a, 188b include respective slots 192a, 192b for reasons similar to those described above with respect to mechanism 10 as will be described in more detail below. Again referring to FIG. 6, in addition to the pivot connections allowing generally vertical movement of the outer end of first arm 170 with respect to base member 174, pivot connections 194, 196 are provided to respectively allow pivoting motion of mechanism 11 about support pole 16 and pivoting motion of second arm 172 with respect to first arm 170. For height adjustment, like the first embodiment, a tubular support member 198 is provided to hold mechanism 11 on support pole 16 and may be locked in place by a conventional screw locking clamp mechanism 200 when positioned at the desired height along pole 16. Referring now to FIGS. 6 and 7, pivot connection 196 more specifically comprises a cylindrical rod 206 received within a pivot support or housing 208 and connected to second arm 172 by a connecting member 210. As best shown in FIG. 7, cylindrical rod 206 is preferably contained within a low friction sleeve or bearing member 211 which, in turn, is disposed within a clamp member 212. As further shown in FIG. 6, a retainer 214 keeps the cylindrical rod 206 held within pivot support or housing 208. Link members 176, 178 of first arm 170 are attached to housing 208 by pivots 184, 186. Still referring to FIG. 6, like the first embodiment, a counterbalancing spring 216 is preferably provided and connected to an adjustment screw 218 at one end for allowing adjustment in the counterbalancing force to be made upon initial assembly or by the user. One end 220 of spring 216 is connected to a threaded member 222 which receives adjustment screw 218 for threaded adjustment therein. The other end 224 of spring 216 is connected to pivot pin 186. As further shown in FIG. 6, a locking mechanism 230 is provided for locking the various pivot connections of arm 11. Locking mechanism 230 is similar to locking mechanism 90 of instrument support mechanism 10. Specifically, a lever 232 operates generally in the direction of arrow 234 to lock pivot connections 194 and 196 as well as the general pivot connection made between base member 174 and first arm 170 which allows vertical adjustment of first arm 170 with respect to base member 174. More specifically, lever 232 is connected by a pivot 236 to second link member 178 and is further connected to a connecting link by a pin 240 extending therefrom and into a slot 242 in the end of lever 232. Short links 244, 246 are connected at respective ends of connecting link 238 by pivots 248, 250. The opposite end of each short link 244, 246 is rigidly affixed to respective screws 252, 254 by retainer pins 256, 258. Thus, it will be appreciated that when lever is pulled away from base member 174 to the position shown in FIG. 6, short links 244, 246 will rotate screws 252, 254 clockwise to simultaneously lock the various pivot connections as will be described. Preferably, screws 252, 254 are each 3/8"--10 double lead screws. Referring now more specifically to FIG. 7, the locking mechanism 230 preferably operates clamp member 212 to selectively allow or prevent rotation of cylindrical rod 206. Specifically, a first portion 260 of clamp member 212 includes a threaded insert 262 for receiving threaded portion 252a of screw 252. A second portion 264 of clamp member 212 interacts with an adjustable screw stop 266. Finally, similar to the first embodiment, a clamp member 268 including a flange portion 268a and a tubular portion 268b is operated by one end of screw 252 to selectively allow and prevent movement of links 188a, 188b. As also provided in the first embodiment, washers 270, 272 are respectively disposed between pivot support housing 208 and link 188b and between links 188a and 188b. Thus, when screw 252 is rotated by short link 244 to move in the direction of arrow 274, clamp member 268 will move upwardly as viewed in FIG. 7 and flange portion 268a will clamp links 188a, 188b against washers 270, 272 and the inside of pivot support or housing 208. This will prevent movement of links 188a, 188b by way of slots 192a, 192b riding along tubular clamp portion 268b and thereby prevent any articulating up and down movement of first arm 170 (FIG. 6). At the same time, portion 260 of clamp member 212 will move generally in the direction of arrow 276 and, as portion 264 is stopped against threaded stop member 266, this will clamp cylindrical pivot rod 206 against any rotation. Referring now to FIG. 8, a clamp member 280 is provided at the opposite end of first arm 170 to selectively allow or prevent rotation of first arm 170 and any attachments about support pole 16. Specifically, clamp member 280 includes a first portion 282 having a threaded insert 284 for receiving threaded portion 254a of screw 254. A second portion 286 of clamp member 280 includes a hole 286a which receives an unthreaded portion 254b of screw 254 with clearance for rotation. Thus, when short link 246 is rotated by connecting link 238 in a clockwise direction as viewed in FIG. 6, screw 252 will move in the direction of arrow 288 and bear against the inside of base member 174. This will cause portion 282 of clamp member 280 to move in an opposite direction and, as portion 286 bears against adjustment screw 290, a clamping action will take place against tubular support member 198. Like the other adjustment screws, screw 290 allows adjustment in the clamping action. Therefore, base member 174 will not be able to rotate about tubular support member 198. Generally referring to FIGS. 6-8, and to summarize the operation of mechanism 11, when lever 232 is pulled in the direction of arrow 234 away from base member 174, short links 244, 246 will be rotated by connecting link 238 and thereby rotate screws 252, 254 in a clockwise direction as viewed in FIG. 6. As shown in FIG. 7, this will move screw 252 in the direction of arrow 274 to clamp links 188a, 188b against any movement and further move first clamp portion 260 in the direction of arrow 276 to prevent any rotational movement of pivot rod 206. In this manner, pivoting of second arm 172 with respect to first arm 170 is prevented and vertical movement of first arm 170 with respect to base member 174 is also prevented. At the same time and referring more specifically to FIG. 8, screw 254 will be moved in the direction of arrow 288 and thereby clamp member 280 against support tube 198 in the manner described above to prevent any rotational movement of mechanism 11 about support pole 16. As schematically shown in FIG. 9, movement of lever 232 in an opposite direction toward pole 16 will rotate screws 252, 254 in a counterclockwise direction thereby unlocking all of the pivot connections described above and allowing readjustment of mechanism 11 to a desired position. While the present invention has been illustrated by a description of various embodiments and while these embodiments have been described in considerable detail, it is not the intention of the Applicant to restrict or in any way limit the scope of the appended claims to such detail. As an example, the various features of the mechanisms described herein in detail may be combined or substituted in various manners. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods as shown and described. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently known. However, the invention itself should only be defined by the appended claims, wherein

1a

The present invention relates to materials for colorizing dental protheses and, more particularly, macroscopic materials are provided for direct insertion into preform dental molds to adjust or accommodate color, hue and value to more closely approximate the natural tooth colorization of the individual. Aesthetics denotes beauty and current dental standards relate aesthetics to natural beauty and thus requires natural appearance, even in a prosthesis placed in an anterior region Shade, anatomy and arrangement of the natural teeth greatly vary among individuals. Aging effects changes in color, translucency and reflectivity in the deep portion of the tooth, as well as the surface luster and characteristics due to attrition on the labial aspect. Other changes may be noted due to age, sex, appearance, and physical attributes of the individual. Although easily sought after, a natural appearance is not easily attainable as the prosthesis may have a china-like appearance, a piano-key like appearance because of a lack of construction, and/or a disharmony of shade from a variation in light source impinging on the device. Color and translucency interact and interrelate to produce tooth shade, and thus it is important to match the color in hue, chroma and value of the prosthesis with the adjacent teeth. Therefore, reproduction of a natural appearance in the tooth requires not only knowledge of shade construction in the metal-ceramic system but also of the natural teeth. Dentists and technicians often have difficulty in selecting and matching shades in dental prostheses. The precise consideration of coloring of the prostheses may be effected by the technicians perception of color, the light source at the time of manufacture and the objects color, which may be due to reflection, translucence or interference. Although vision is influenced by the effect of consistent chromatic perception, the color of a given object in value and hue between the object and its background seems different due to contrast. Indicative of the difficulty for the technician is the necessity of matching colors on a plaster model where the brightness of the plaster may cause an error. If a crown is fabricated neglecting the shape in the incisal area, total reflection may be completely lost or range over too narrow or wide an area, which may make the tooth appear artificial in color at the incisal area. Artificial teeth and teeth implants are generally produced from metals, resins and dental porcelain. These materials have their own natural color and texture, which is different than natural teeth and more specifically is different than any individual's tooth color. Various artistic techniques are utilized by the technician to accommodate and match the coloration of a natural tooth to the prosthetic implant to avoid highlighting the existence of the dental implant, which will make the patient more at ease with the prosthesis. Dental prostheses and more particularly bridges are broadly provided by forming an underlying support post of a metal, such as gold, palladium or platinum. Thereafter, a porcelain overlayment is formed on the support post, shaped to the desired configuration for the individual and fired to provide a hard, shiny tooth. However, the fired tooth porcelain has a distinctive white color that is not generally the color of natural teeth and would not include the natural lines or color changes visible in various parts of natural teeth. The appearance of the prosthesis is affected by numerous factors including the chemical composition of the underlying support post; the composition of the porcelain; the thickness of the tooth cross-section at any point; the morphology of the tooth surface; and, additive coloring agents provided to effect the hue and tone of the tooth surfaces. In addition, the heat treating and firing technique impacts upon the resultant finished porcelain as well as the physical and chemical bonding of the structure, and consequently the appearance of the prosthesis, which is one of the primary considerations of the dentist. Further, any prostheses treatment must provide a structurally sound and stable apparatus for insertion and durability in the patient. Satisfying these goals require the support post to be properly prepared before porcelain fusing, which provides good bond strength and, consequently an increase, of the metal-ceramic system. Indicative of the plurality of steps and operations required to prepare a prosthesis is the meticulous care in providing a solid metal-ceramic bond, as porcelain does not easily or naturally bond to the noble metals, gold, platinum or palladium, which are the base metal of the underlying support posts. However, these same metals are not easily oxidized and generally carry tramp materials, such as tin oxide along at their surfaces. These tramp materials affect the coloration of the overlaying porcelain on the support post and special effects techniques are utilized by the technician to accommodate the color prior to firing and glazing the porcelain preform in a kiln or oven. Coloration, as noted above, is a critical factor in the preparation and provision of dental implants. Indicative of an effort to control the color of a porcelain is the staining material taught in U.S. Pat. No. 4,693,748-Kobayashi et al., which coloring component is to provide a color closer to the more natural tooth color. These coloring components include additions from among a plurality of metal oxides, which additions add a coloration to the porcelain base to more closely approximate a natural tooth color. Another dental restoration technique provides a plurality of layers including a translucent layer overlaying a more opaque ceramic layer, each layer having a uniform and matching color. This multiple layer structure is taught in U.S. Pat. No. 4,828,117 to Panzera et al., which also discloses a kit for the preparation of the restoration. Further attempts at controlling color have been provided by utilizing an organic liquid binder comprising a mixture of organic liquids with an index of refraction similar to the porcelain powder. An insert for composite dental restoration is disclosed in U.S. Pat. No. 4,744,759 to Bawer, which provides a composition and technique for micromechanical and chemical bonding with composite resins. However, none of the above accommodate color correction in the morphology of the restoration. The changes in the special effects may be for dentine effects, incisal effects or surface stains. The dental restorations have been colored with striation-like characteristics by mechanically marking or trenching the preform, providing a colorizing material, such as a colored dentine powder, in the outline with a brush and sealing over the outline prior to firing the porcelain restoration. This requires considerable artistic talent and technique in selecting and applying the coloring agent with a brush, that is the proper amount of the colorant with the correct trench depth. SUMMARY OF THE INVENTION The present invention provides thin agglomerated shards of coloring agents in either regular or irregular discrete pods or packages for insertion into dental preforms to provide the desired morphological tooth characteristics and special effects without otherwise sculpting the tooth for these colorizing additions. Further, the colorizing shards are provided in a plurality of colors for selection by the dental technician without concern for the quantity of powder material on a brush end. BRIEF DESCRIPTION OF THE DRAWING In the Figures of the drawing, like reference numerals identify like components, and in the drawing: FIG. 1 illustrates the addition of a binder into a mixing glass with a powder colorizing agent; FIG. 2 illustrates representative shards of an agglomerated colorizing agent; FIG. 3 is a plan view of a representative dental restoration; FIG. 4 is a cross-sectional view of the prosthesis in FIG. 3 taken along the line 4--4; FIG. 5 is a plan view of a dental preform; and FIG. 6 is a cross-section of a preform and the insertion of a brushed-on dentine special effect. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A dental restoration preform 10 is illustrated in FIGS. 3-6 in plan and cross-section. Restorations 10 are illustrated in their preform and pre-glazed state for shaping, morphological changes, and special effects in the teeth for their conformation to the desired finished dental restoration. The restoration or prosthesis changes may be along the margins and incisal areas of the teeth, and include indentations 12, grooves 14, coloring 16 and other characteristics of natural teeth. The grooves 14 and morphological characteristics provide areas of reflection and refraction in natural teeth, which add to the color, hue and chroma of the natural tooth in the mouth. Therefore, it is incumbent upon the dental restoration technician to provide not only the white porcelain characteristic for the tooth, but also to provide these reflective and refractive surfaces Consequently, restorations 10 are colored not only in the substrate porcelain but also in the several grooves 14, indentations 12 and other areas. Referring to FIG. 4, restoration 10 is provided in the dentine 16, the gingival or neck region 18 and in the incisal areas 20 with narrow slits, grooves and color additions in relative relation to the above-noted naturally occurring positions in the teeth. These changes are in addition to the color control of the base porcelain. It is the practice within the art to provide these several prostheses areas with colorations approximating the characteristics of the teeth to be replaced. Accommodation of the colorations must provide for variation of light density, reflection and refraction from the surface and underlying substrate of the porcelain in the teeth. Therefore, coloring additives are selected for addition to the porcelain from among the group of metal oxides including the following: silicon dioxide; aluminum oxide; sodium oxide; potassium oxide; stannic oxide; barium oxide; ferric oxide; boron oxide; magnesium oxide; silica; chromic oxide; cobalt oxide; iron oxide; manganese; nickel oxide; tin oxide; titanium dioxide; vanadium oxide; zinc oxide; zirconium oxide; and indium oxide. These additions are generally available as powder coloring agents and may be colored porcelain powders. The individual colors resultant from the particular oxide are known in the art and will not be specifically discussed here. It is known that combining two or more of these oxides will provide variations on a resultant coloring oxide powder, however the precise blend or color will not be considered here. Development of tooth structure and preparations of dental restorations require control of both the morphology and color to provide a more natural restoration. The morphology and natural-like appearance of the restoration is enhanced by colorizing from the technician to provide the proper reflective and refractive surfaces, cavities and lines on the tooth surface or subsurface. These lines on the marginal and incisal areas have been provided by applying a coloring agent 24, such as one of the above-noted colorizing agents, to a groove 14 or slot 22 in the preformed restoration. Colorizing agent 24 is generally a powder applied by a brush tip 26 of brush 28, as shown in FIG. 6, into slot or groove 14 in FIG. 3 and thereafter overlaying porcelain to retain this contrasting addition within the porcelain. Subsequently, the firing or glazing of the porcelain restoration 10 in a kiln or oven provides the glass-like structure for the finished dental insert or restoration 10. Retained colorizing agent 24 provides a contrasting morphological characteristic within the hardened porcelain structure. This morphological characteristic or special effect provides a contrasting point for reflection, or refraction, to more closely approximate the physical characteristics of a natural tooth. Brush application of colorizing agents 24 is hindered by the care required of the technician to provide the proper quantity of a coloring agent at the right depth within the restoration. These requirements provide variations in resultant tooth restoration, which lead to variations for the technician and provide difficulties in reproducing or providing a natural tooth appearance on restorations. Therefore, it is a better technique, if possible, for such applications to minimize the potential hazard for error during restoration formation. A method has been developed to insert at the proper location with a minimal amount of artistic technique a coloring agent, such as the above-noted metal oxide salts, which are normally provided in a physical powder-like state. As noted, the handling and applying of powders 24 to the tooth restoration crevices requires careful technique and frequently leads to repetitive operations to overcome mishaps during the forming and shaping of the restoration. The present invention provides agglomeration of special effect powders 24 such as by the addition of binders and/or firing in an oven or furnace. Illustrative of this in the powder agglomeration is the addition of a binder 32 in FIG. 1 into a mixing plate 34 with a thin layer of powder 24 to provide an agglomerate. This binder may be an air-drying composition or curable at elevated temperatures by heating. A representative binder, which may be an 11% xylene solvent, 1.6% Kellox oil, 5% plasticizer S-160[Monsanto] and 8-9% AT-51 acrylic binder [Fisher Scientific] and the balance being the metal oxide [ceramic] coloring additive. The binder acts as an agglomerating agent but does not change the physical properties of the powder materials, which binders may contain acrylic polymers or vinyl polymers as well as surfactants, plasticizers, or adhesion and porosity modifiers. In some cases, the bound powders are fired and thereafter ruptured or broken into discrete glass-like shards and stored in distinct containers. The binder does not chemically interact with the powders to change the color additive property for its inclusion into the porcelain material. The agglomerated or fired mass, which may be provided in any thickness, is broken into a plurality of shards 36, having either irregular or regular shapes as illustrated in FIG. 2. In an exemplary illustration, upper surface 40 of a molar-like restoration preform 38 in FIG. 5 has crossing grooves 14. Grooves 14 cross at a common point 42 approximately at the center of this tooth, which may be contoured similar to a natural molar. The plurality of grooves 14 and contour lines, as well as the irregular structure of a tooth, are illustrated in FIG. 3 in an exaggerated fashion to demonstrate the field available for the technician for placement of color additives 24 or striations during the manufacture or preparation of a dental restoration. However, upper surface 40 has been provided with a plurality of the coloration shards 36, which do not have to be any one coloring agent, inserted by the technician into a groove 14 or alternatively pressed into the soft preform surface. Each shard 36 may be grasped, such as by a tweezer, and directly inserted into the gelatinous surface of restoration 10 in its preformed state, which shards 36 may be covered over by porcelain or glazing materials. In FIG. 4, insertion of shards 36 into the general center of the tooth structure is illustrated in the cross-sectional view provided along line 4--4 of FIG. 3. In this illustration, shards 36 are generally inserted centrally within the lower reaches of contoured upper surface 40. Shards 36 may also be provided along the surface of the margins of the tooth 10 for overlayment by porcelain prior to firing. Thereafter, the prepared preform may be inserted into a furnace for treatment of the porcelain to provide it with its glass-like surface. It is appreciated that individual shards 36 of an agglomerated colorizing agent may be inserted in discrete locations along the margins or incisal areas of the tooth preform by tweezers without first furrowing a trench for receipt of the coloring agent. However, it is contemplated that such furrowing may be utilized at the discretion of the technician. In either the unfurrowed or furrowed state, a selected shard 36 may be inserted into the restoration by the technician and it does not require the artistic limitation of a careful brush stroke, material concentration, or furrow depth to attain the correct colorizing effect, as required in the present brush-stroke techniques. The above-noted shards 36 may be provided in any shape and thickness. In a preferred condition a plurality of shards of colorizing agents, such as the above-noted oxides, would be provided in a pallet or kit-like arrangement for selection by the restoration technician. The kit may include a collection of packaged shards, which packaging may be bottles, blister packs, or pods in a ballet board for example. The precise packaging arrangement is a supplier or user election. While only specific embodiments of the inventions have been described and shown, it is apparent that various alterations and modifications can be made therein. It is, therefore, the intention in the appended claim to cover all such modifications and alterations as may fall within the scope and spirit of the invention.

1a

FIELD [0001] The present invention relates to a device for restraining articles. More specifically, the present device may be used to restrain toiletries to a ledge of a bathtub or shower, and/or to create new storage space for toiletries in the bathtub or shower. BACKGROUND OF THE INVENTION [0002] There are many known shower and bathtub devices for holding toiletries such as shampoo, body wash, toys, etc. For showers, caddies or racks are typically used, and are often screwed into the wall of the shower or hung over the showerhead. For bathtubs, trays across the ledges of a bathtub are often used. Bucket type devices also exist which fit into the corner or suction to the wall of the shower or bathtub. These devices are often required as existing ledges in the shower and/or bathtub are not wide enough to hold the toiletries, or because additional storage for toiletries is required. [0003] Often these shower and bathtub devices are made of rigid plastic or wire and are designed for permanent use in the shower and/or bathtub. These devices are not designed to be portable. In fact, to detach many known shower or bathtub devices requires effort and/or the use of tools. [0004] Many of the devices have small holes and/or openings, which allow water to drain out the bottom of the device. Soap scum often collects in these small holes and/or openings making the device difficult to clean. Consequently, there is a need for a shower and/or bathtub device that is not only secure, but also portable, and easy to clean. [0005] With many shower and/or bathtub devices for holding toiletries there is often a risk of a toiletry such as a shampoo bottle, falling out or off of the device. This often requires the person standing in the shower or bathtub to jump back, and may results in a slip and fall or a bruised toe or foot. The problem of falling toiletries also occurs when the ledge of the shower or bathtub is used for the toiletries. As such, there is a need for a shower and/or bathtub device which provides additional storage for toiletries, and which eliminates the risk of falling toiletries out or off of the device. Further there is a need for a device, which prevents toiletries from falling from an existing ledge of the shower and/or bathtub. SUMMARY OF THE INVENTION [0006] According to the invention there is provided a restraining device for preventing items positioned on a ledge against a wall from falling, comprising a flexible panel, and an attachment device connected to the flexible panel. The attachment device attaches to the wall such that the flexible panel restrains the items from falling when the items are positioned on the ledge and the attachment device is attached to the wall. The restraining device may also create additional storage space by restraining items against the wall using the flexible panel when the attachment device is attached to the wall. [0007] Preferably, the restraining device is removeably detachable from the wall. Suction cups may be used as the attachment device. [0008] The flexible panel may be made from semi rigid plastic and may have a variety shapes such as rectangular, or ovoid shape. Inserts may be places in the flexible panel to provide rigidity and to enable the flexible panel to take a shape. [0009] The length of the restraining device may be adjusted by moving the attachment devices or by adjusting the length of the flexible panels. BRIEF DESCRIPTION OF THE DRAWINGS [0010] Further features and advantages of the invention will be apparent from the following detailed description, given by way of example, of a preferred embodiment taken in conjunction with the accompanying drawings, wherein: [0011] [0011]FIG. 1 is a front view of the restrainer; [0012] [0012]FIG. 2 is a perspective view of the restrainer in use restraining items on a ledge; [0013] [0013]FIG. 3 is a front view of the restrainer with a narrow panel in use restraining items on a ledge; [0014] [0014]FIG. 4 is a perspective view of the restrainer with a panel that surrounds the item on a ledge; [0015] [0015]FIG. 5 is a front view of the restrainer with a rectangular panel, restraining items against a wall; [0016] [0016]FIG. 6 is a front view of the restrainer with a trapezoid shaped panel, restraining items against a wall; [0017] [0017]FIG. 7 is front view of the restrainer with a semi-rigid insert; [0018] [0018]FIG. 8 is a front view of the restrainer with an adjustable length using semi-rigid inserts; and [0019] [0019]FIG. 9 is a front view of the restrainer with an adjustable length using sliding adjacent panels. DETAILED DESCRIPTION OF THE INVENTION [0020] Referring to FIG. 1 a front view of the restrainer 10 is shown. The restrainer 10 is comprised of a panel 12 with a suction cup 14 attached to each corner of the panel 12 . The panel 12 may be made of a semi-rigid or pliant material, such as plastic or fabric mesh, and may be folded into a compact size for traveling purposes. [0021] Referring to FIG. 2 a perspective view of the restrainer 10 is shown. The restrainer 10 may be used to prevent items 18 on a ledge 16 from falling off of the ledge 16 . The panel 12 restrains the items 18 , and the suction cups 14 secure the panel 12 to the wall 20 . [0022] The panel 12 is shown in FIGS. 1 and 2 to be of a rectangular shape, however other shapes may be used for the panel 12 , such as square or ovoid. Further, although a suction cup 14 is used at each corner of the panel 12 , any number of suction cups 14 may be used to adhere the panel 12 to the wall 20 . Referring to FIG. 3 a restrainer 10 with a narrow panel 12 is shown restraining items 18 on a ledge 16 . In this embodiment only one suction cup 14 is located at each end of the narrow panel 12 to restrain the items 18 against the wall 20 . [0023] Referring to FIG. 4 a perspective view of an alternative embodiment of the restrainer 10 is shown. In this embodiment the panel 12 surrounds the item 18 positioned on the ledge 16 . The suction cups 14 are attached to the wall 20 from a tab 15 , which extends from the outside of the panel 12 . [0024] Referring to FIGS. 2, 3 and 4 the items 18 may be toiletries such as shampoo, or body wash, as commonly found on ledges 16 of showers and bathtubs. When the suction cups 14 are connected to the wall 20 of shower and/or bathtub the restrainer 10 will prevent items 18 such as shampoo bottles from falling off the ledge 16 . Advantageously, the restrainer 10 not only enables the corner ledge of the shower and/or bathtub to safely be used to hold items 18 , but also enables the main ledge, which is often narrower than the corner ledge, to be used. [0025] Referring to FIG. 5 a front view of the restrainer 10 is shown restraining items 18 against the wall 20 . As shown in FIG. 1, the restrainer 10 is comprised of a panel 12 with a suction cup 14 attached to each corner of the panel 12 . The panel 12 may be made of a semi-rigid or pliant material, such as plastic or fabric mesh, and may be folded into a compact size for traveling purposes. In this embodiment a new storage space is created by attaching the suction cups 14 against the wall 20 . Items 18 may then be inserted between the wall 20 and panel 12 . [0026] As previously discussed, the panel 12 may come in a variety of shapes and sizes. Referring to FIG. 6 a front view of a restrainer with a trapezoid shaped panel 12 is shown. Suction cups 14 are located at each corner of the panel 12 and are attached to wall 20 to restrain item 18 . The top two suction cups 14 are placed closer together to create a basket effect. [0027] Advantageously, the restrainer 10 , as shown in FIGS. 5 and 6, may be used to create additional storage spaces in the bathtub and/or shower for toiletries, such as shampoo, body wash, or soap. [0028] Referring to FIG. 7 a front view of the restrainer 10 is shown with inserts 28 . The inserts 28 may be used to add rigidity to the panel 12 , or to provide malleability in order to shape the panel 12 , which for example would enable the panel 12 to meet the specific shape of a ledge or corner. The inserts 28 slide into the trim 26 , which surrounds the outer periphery of the panel 12 . The inserts 28 may be made of plastic or plastic covered metal. Suction cups 14 are located at each of the corners of the panel 12 . [0029] Referring to FIG. 8, a restrainer 10 having a panel 12 with an adjustable length is shown. The restrainer 10 has a trim 26 that runs along the periphery of the panel 12 and may be used to hold semi-rigid inserts 28 . As shown, in FIG. 8 a semi-rigid insert 28 is found on the left and right of the panel 12 . Suction cups 14 are located at each end of the semi-rigid inserts 28 . The semi-rigid inserts 28 may be made of plastic or plastic cover metal. The length of the panel 12 may be adjustable by wrapping the unneeded length of the panel 12 around the semi-rigid insert 28 on the left, right or both sides of the panel 12 . [0030] Alternatively, referring to FIG. 9 the length of the panel 12 may be adjustable by the use of two panels 12 that are fitted adjacent to each other by flexible troughs 22 on the upper and lower edges of the panel 12 . The flexible troughs 22 enable the panels 12 to slide such that the length 24 may be increased or decreased. Each panel 12 has two suction cups 14 located on vertically adjacent corners. [0031] The position of the suctions cups 14 may also be moved such that the length of the panel 12 may be adjusted. Although suction cups 14 are used to adhere the panel 12 to the wall 20 , any means may be used that is detachable, yet secure. [0032] Advantageously, the restrainer 10 avoids drainage problems as water is not trapped in small holes and or openings, and the panel may be easily rinsed or washed. [0033] Accordingly, while this invention has been described with reference to illustrative embodiments, this description is not intended to be construed in a limiting sense. Various modifications of the illustrative embodiments, as well as other embodiments of the invention, will be apparent to persons skilled in the art upon reference to the description. It is therefore contemplated that the appended claims will cover any such modifications or embodiments as fall within the true scope of the invention.

1a

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority from U.S. Provisional Application No. 61/000,180, filed on Oct. 23, 2007, which is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates generally to action games. In particular, the invention is related to computer-implemented methods for pen-based or pointer-based computing whereby players or users can interact with moving and transforming objects. BACKGROUND OF THE INVENTION [0003] An action game is a game that challenges a player's speed, dexterity, and reaction time. Action games often include tactical conflict, exploration challenges, and puzzle-solving, but these are not defining elements. Action games are the broadest and most inclusive genre in gaming, encompassing many diverse sub-genres. The present invention introduces a new computer game for a wide variety of computer devices and introduces new rules and strategies to the art of action games. SUMMARY OF THE INVENTION [0004] The present invention is a new computer game that can be played on e.g. smartphones, game consoles, handheld gaming consoles, PCs, special purpose gaming devices, or the like. New rules and strategies are presented and involve the interaction with moving and transforming objects. [0005] The centerpiece in the game is a two-dimensional object (referred to as “The Bubble”) that is capable over a period of time of changing its shape, size, form and moving across a display, interacting with other objects and interaction with the borders of the display. A morphing engine is implemented that is capable of continuously transforming The Bubble object shape to another shape. These transformations occur when The Bubble is continuously moving on the display of the device. [0006] Each Bubble object defines an internal area and an external area. The external area is defined between the inner borders of the display and the outer borders of the object. An energy dot game logic is implemented that is capable of releasing (or entering) one or more energy dots onto the display. Each of the energy dots is capable of: (i) appearing on the display in the external area around the object, (ii) entering through the object border into the internal area of the object, (iii) bouncing off the internal borders of the object once in the internal area, and (iv) causing the object to grow in size once in the internal area. [0007] A player through means of a pointer is capable of (i) capturing the energy dots or (ii) cutting off parts of the object that contain one or more energy dots.e Each of the cut-off parts of the object either disappears from the display or reunites with the object depending on a set threshold or the rules of the game. [0008] A chain-saw fuel engine is implemented for allowing the player to (i) perform cutting off parts of the object containing one or more energy dots or (ii) capture one or more energy dots. The amount of chain-saw fuel consumed is a function of the amount of time spent cutting off the object parts. The amount of chain-saw fuel increases when one or more of the energy dots have been captured in the internal area of the object. The amount of chain-saw fuel decreases when one or more of the energy dots have been captured in the external area of the object. [0009] The player wins the game when the object or object parts disappear(s) from the display. The player looses the game when the size of the object reaches the size of the display. BRIEF DESCRIPTION OF THE FIGURES [0010] The present invention together with its objectives and advantages will be understood by reading the following description in conjunction with the drawings, in which: [0011] FIG. 1 shows according to an exemplary embodiment a handheld device displaying the computed-implemented method of this invention. [0012] FIG. 2 shows according to an exemplary embodiment of this invention a object (The Bubble) with energy dots. [0013] FIG. 3 shows according to an exemplary embodiment of this invention the method of cutting off a part of a object (The Bubble) containing an energy dot. [0014] FIG. 4 shows according to an exemplary embodiment of this invention a object cut into two final parts. DETAILED DESCRIPTION [0015] The present invention is referred to as “The Bubble” and is a computer-implemented method or interactive action game for pointer 130 (pen, stylus, fingertips, mouse or the like) based PDAs/hand-held computers, gaming consoles, PCs. FIG. 1 shows an example of such a device 110 with a display 120 . An object morphing engine could display one or more objects 140 A, B (also referred to as The Bubbles) on display 120 . Each object 140 A, B defines an internal area within the borders of the respective object and an external area defined between the internal borders of display 120 and the outer border of the object. The object transforming engine dynamically changes the shape or form of each object into another shape. The transforming (morphing) engine could be based on the following methodology, either in any combination or separately: 1) The morphing engine or algorithm transforms the shape of The Bubble to either pre-defined shape(s), (pseudo-) randomly generated shapes or other methods. The result of the transformation is a new Bubble object of the same square size as the initial (or prior) Bubble object. 2) As the transformation progresses from one state to another state, the object properties or qualities are maintained. For example, the object can move across the display, rotate, change shape, and the parts could also be further cut into smaller object parts. 3) During the process of transformation(s) the square size object is maintained. 4) The square size of the object is automatically corrected in case of an action by the player and an interaction with other objects. 5) Cut-off parts could continue its independent morphing sequence that can differ from the main object. 6) Transformations don't change the moving or rotating of the object. 7) The transformation velocity is not linear and can change depending on the game situation and settings. 8) Transformation could assume attaching or detaching of the objects form the main object. 9) The object can be separated by parts without direct cutting following the game rules. Game Concept and Rules [0025] To win the game a player shall cut off parts of The Bubble to make it disappear, while fighting against the Energy Dots 150 which are getting into The Bubble and make it grow bigger. If The Bubble gets to the size of the screen/display 120 then the player loses. [0026] The Bubble game has the following main elements: The Bubble is a moving and transforming object (e.g. 210 in FIG. 2 ), constantly and smoothly changing it's shape; Energy Dots 150 , small round objects, bouncing within the rectangle game area of, for example, display 120 , are the sources of energy; and A player's pen or other pointing device 130 is used to: a) cut off parts of The Bubble (Chain-saw mode); b) push The Bubble or parts of it; or c) capture Energy Dots. The Bubble [0033] As mentioned infra, The Bubble constantly changes its shape, but keeps the same square size. It can change by the following three events: 1) It can enlarge if The Bubble has been hit by an Energy Dot; 2) It can reduce if the Player ‘cuts off’ a part of it; and/or 3) It can blast if The Bubble loses its critical mass (becomes too small). [0037] In one embodiment, the game starts with The Bubble (e.g. 210 in FIG. 2 ) floating in the center of the screen 120 . The shape constantly changes, but smoothly curved and the square size of The Bubble remains constant. Energy Dots [0038] Initially The Bubble has several ‘energy dots’ floating inside it (i.e. 150 in FIG. 2 marks 1 energy dot). The tracks ( 220 A-D) of these energy dots are linear and once inside The Bubble they are bouncing from The Bubble's internal borders. [0039] In, for example, a randomized period of time (1-5 seconds) a new Energy Dot could start off from outside of the screen and directed towards The Bubble (see e.g. 220 A in FIG. 2 ). [0040] If a player detects this energy dot and hits it with a pen (stylus) (or a mouse pointer) 130 the dot disappears and the player gets a raise in the level of available ‘Chain-saw fuel’. A Chain-saw fuel indicator 160 is shown in FIG. 1 . [0041] If a player couldn't hit the Energy Dot, the energy dot could then enter The Bubble. As a result of accumulating more energy, The Bubble gets larger. Chain-Sawing the Bubble [0042] Chain-sawing The Bubble is a centerpiece of the game. A player can make The Bubble smaller by cutting-off 310 a part of The Bubble. The goal is to cut-off parts of The Bubble that has an energy dot 320 inside of it ( FIG. 3 , see also infra). [0043] Depending on the area size of the detached portion the following can happen next: 1) If the cut-off area is too small to balance with the Energy dot, the detached portion will blast after a period of time. The more accurate a player cuts off the object part the less time is required waiting for the blast. The Bubble becomes smaller (The best outcome). 2) If the cut-off area is in balance with the Energy Dot, the detaches portion continues to float separately but will steadily be attracted to each The Bubble. The Bubble then gets the size it was before the cut. 3) If the cut-off square area is too big than allowed by the game rules, the detachment is not possible. The detached parts re-unite immediately. A player can use the pointer to push detached portion off The Bubble. This strategy may be necessary before this part blasts or to win some time before the parts re-unite. [0047] In case the player cuts off an area without any Energy Dot in it, then this part re-unites with The Bubble immediately but the square size becomes bigger than it was before on a defined by the game rules percent. [0048] The following limitations to cutting are applied: 1) Cutting consumes Energy (Accumulated by intercepting Energy Dots); 2) The longer the cut the more energy it consumes (Some progressive scale); 3) Too slow cutting doesn't work as the cut's sides open and then close back up; 4) Too quick cutting doesn't work as the pen/pointer “slides” without making a cut. Winning/Losing [0053] The Player wins the game if it can reduce The Bubble, so that further dividing it to the two parts 410 A, B that make both parts blast (FIG. 4 )—“The final cut 420 ”. The Player loses if The Bubble grows to the size to reach dotted-lines boundaries of display 120 . Games Strategies and Levels [0054] During the game the player tries to locate the best shape and track for the cut (shortest path, with Energy Dot inside). When the cut is made the player pushes the parts apart (or away) from each other waiting for one or both to blast. The player tries to shoot (or capture) as many of the Energy Dots to maintain its energy level (Chain-saw fuel 160 ) at the maximum. The game can be played at different levels, whereby each level introduces more sophisticated and less predictable trajectories for Energy Dots and The Bubble movements. [0055] As one of ordinary skill in the art will appreciate, various changes, substitutions, and alterations could be made or otherwise implemented in either hardware and software without departing from the principles of the present invention. For example, over time The Bubble could be cut in parts or can be slightly cut. If it is cut in parts, each part remain properties or qualities of The Bubble, e.g. the parts are capable of moving across the display, rotating, changing shape, and the parts could also be further cut into smaller Bubble parts. These parts of The Bubble could collide with each other and form joint and bigger Bubble objects. These parts of The Bubble could also disappear and/or appear in various parts of the display according to the rules of the game. [0056] In another example, The Bubble can be cut in different ways. For example, The Bubble could be cut slowly in one move, or it could be cut with several small moves, depending on the specific implementation of the game. If the hardware platform supports multi-touch interaction, The Bubble object could be divided into parts by tearing its parts in different directions. If the hardware platform supports pressure sensors, The Bubble object could act in a specific way to reflect the different pressures applied to it. The Bubble edges created by cutting can also re-unite back if the velocity of cutting is not maintained in accordance to the rules or the changing of the shape of The Bubble. [0057] In yet another example, interaction(s) of The Bubble with for example the outer borders/walls of the display, other parts of The Bubble or other objects on the display could cause the Bubble to change its velocity, rotation, shape. The Bubble could also break apart into parts as result of a collision or too fast movement. [0058] Accordingly, the scope of the invention should be determined by the following claims and their legal equivalents.

1a

CROSS REFERENCE TO RELATED CASES [0001] The present application claims the benefit of and incorporates by reference in its entirely U.S. Provisional Application No. 60/356,838 filed Feb. 14, 2002. FIELD OF THE INVENTION [0002] The present invention relates generally to the use of micro particles to tag or mark edible products such as foodstuffs. The tags themselves are edible. BACKGROUND OF THE INVENTION [0003] Multi-color, layered micro particles called microtaggants have been known to the practice of anti-counterfeiting, authentication, and explosive tracing for decades. These micro particles are typically composed of non-biodegradable synthetic plastics such as melamine polymers. They are unfit for rapid biodegradation with proteases, lipases, or other digestive enzymes. They work well for rapid, on-site visual identification and do not require the use of special tests or other instruments (besides light magnification) like other biodegradable tracers such as those patented by Biotag or Isotag. Single-layered particles with two-dimensional barcodes are also known to us. BRIEF DESCRIPTION OF THE DRAWINGS [0004] [0004]FIG. 1 is a micro particle in accordance with the invention; [0005] [0005]FIG. 2 is a fragmented micro particle in accordance with the invention. DETAILED DESCRIPTION [0006] The micro particle of FIG. 1 has a substrate made from a material that is biodegradable and non-toxic the representative particle is about 50 microns on a side. In use, micro particles may be to add to food items that are ingested by humans and by livestock or other animals. The micro particles may also be used in the pharmaceutical industry through their application to pills that are placed in the human digestive tract. Currently there is a problem with counterfeit medications being sold on the black market and there are distribution agreements being broken. The micro particle carries an identifying code that can be used for retrospective identification of the marked product. [0007] The general structure of the particle 10 may be a multilayered with a planform that is roughly a rectangular or square cube with some irregular sides. The shape may also be cylindrical with multi-layered concentric cylinders. Another alternative is a single-layered design with at two-dimensional barcode imprinted, which is illustrated in FIG. 1. [0008] The preferred substrate of the micro particles will be a biodegradable polymer or other substance that is biodegradable. This may include but is not limited to: polysaccharides, starches, polypeptides, proteins, poly-amides, polyglycols, fatty acids, polyester, triglycerides, etc. Specific material compositions include poly-lysine and poly-aspartic acid based polymerrs. Another alternative is to use layers of dead cells or biological tissues, i.e. dried sterile intestinal tissue. [0009] The identification code or indicia can be based on visual colors, fluorescent compounds, phosphorescent compounds, infrared compounds, near-infrared, upconverting phosphors, etc. A possible composition of such micro particles would be to use FDA approved food colorings in multiple layers composed of polysaccharide. Another code system would be to use a two-dimensional barcode system in which the barcode is placed into or onto a particle. The preferred method of making the particle 10 is to stamp or emboss the code onto a planar substrate and to handle the material as a sheet. The sheet may be fragmented thermally to make the micro particles. The embossing technique leaves slight depressions in the particle, which renders them optically readable. Contrast is achieved between the depressed marks and the surrounding material though optical processes that are not well understood at this time. Depressions of just a few microns are sufficient to create sufficient contrast to permit “reading” under the correct illumination. In general the particles may be read in white light using phase contrast microscopy. Other reading methods may be used as well. [0010] The code can be identified by direct visual inspection using magnification under normal white light or other appropriate light conditions such as darkfield fluorescence. The code will be identified prior to inspection (e.g. on the pill prior to administration) or may be read after the animal or human has ingested the material it has been attached to (be it food or drug). In the latter case, the micro particle should not be able to be digested fully so as to make it impossible to read the code. It should be biodegradable post-excretion however. [0011] For other applications it may be desirable to have coded particles that are entirely dissolved in the aqueous solution of the digestive track. Water-soluble polymers may work ideally for this purpose. The particles are therefore edible by humans and are both digested and absorbed or simply excreted. [0012] It is important that the micro particles are non-toxic to animals, humans, and the environment. Generally regarded as safe (GRAS) substances approved by the FDA can be used to satisfy this requirement of being non-toxic to humans and can be incorporated into food inputs and foodstuffs. Many of the aforementioned substances fall into this category and other specific substances listed as GRAS are: polyethylene, polymaleic acid, polysorbates, polyethylene glycol, polypropylene glycol, polyoxypropylene glycol, polyvinylpyrrolidine. Other substances that fall into this category include agar, kelp, rice paper, seaweed paper. [0013] Enclosed are photomicrographs of micro-molded particles, which may be manufactured from rice paper and seaweed. In the FIG. 1 the particle 10 is generally rectangular in shape and is relatively thin. A coordinate system 12 is used to orient robotic vision to determine the location of dots or spots 14 on the particle which are used to create a identifying number or the like. In use the particles will be either cut from or fractured from a laminar substraight with a micro-molded set of taggant zones. This particulate will be mixed with the foodstuff, or adhere to the foodstuff using a conventional adhesive process or a conventional mixing process. In transit and in its final destination the coded particle will retrospectively identify the origin of the foodstuff. Although two-dimensional bar code is a preferred indicia system conventional alphanumeric or other encoding schemes may be used. It is preferred to emboss the code on the particle or mold it in a press however other marking system is within the scope of the invention. The preferred techniques rely on the optical properties of the embossing to provide contrast to read the indicia this in essence requires a 3-D code that has a characteristic depth as well as spatial location on the particle body. [0014] The fracturing technique may take any one of known forms including but not limited to the use of liquid nitrogen to freeze the particle which is then ground producing randomly sized and randomly oriented marked particles. It is important to note that the fracturing process need not produce perfectly rectangular particles the bar code can be reliably read with less than one particle as illustrated by the particle 18 seen in FIG. 2.

1a

BACKGROUND OF THE INVENTION Gun racks mountable on rear or side windows of vehicles have previously been disclosed in the art. Such racks have also taken the form of two spaced, unconnected members, the ends of which are adapted to fit between the rubber gasket and the window glass, the members being each adjustable in length to adapt to window frames of several standard sizes. Elkins et al, in U.S. Pat. No. 3,876,079, provides such a structure, the gun rack members therein disclosed being installable in spaced superimposed relationship upon a window of a vehicle without the need to drill holes or provide fittings on the window for mounting of the gun rack members. The Elkins et al device is adjustable within a given range of lengths and, as such, can fit windows of several standard sizes. The present invention provides a gun mounting rack useful in vehicles in a manner similar to that of the Elkins et al device; however, the present mounting rack provides structure capable of continuous adjustment of the respective lengths of spaced rack members throughout the full relative extension of coacting slide elements forming each rack member. As a result of this structure, the present mounting rack members can be caused to fit vehicular windows of any possible size as well as to enable mounting, with the addition of bracket members, to walls and other structural supports, the present rack members being extendable to accommodate a desired vertical spacing between the bracket members. Issued U.S. patents in addition to the Elkins et al patent previously referred to and which may be pertinent to the presently disclosed invention include: Nos. 2,536,293 -- Koses - January, 1951 2,550,796 -- Francis - May, 1951 2,599,824 -- Griffin - June, 1952 2,746,661 -- Kaplan - May, 1956 2,764,332 -- Lemley - September, 1956 3,007,582 -- Lindstrom - November, 1961 3,294,247 -- Norrington - December, 1966. SUMMARY OF THE INVENTION The present invention provides a mounting rack for rifles and similar firearms, the rack comprising laterally spaced support members secured in spaced relation to a window of a vehicle or to brackets mounted on a wall or similar supporting structure. Each support member is comprised of first and second coacting slide elements which are movable relative to each other, each element having opposed support blades which can be inserted between the rubber molding and the glass portion of a vehicle window or which can be inserted within vertically spaced mounting brackets provided on a wall or the like. One of the slide elements carries at least one cradle member, two of the spaced support members providing support for a rifle or the like at two spaced points along the length of said rifle. The support members of the invention are extendible to lengths varying from less than the length-wise dimension of the longest slide element thereof to nearly the combined lengths of the two slide elements. A major portion of one of the slide elements is formed into a U-shaped track within which the other of the slide elements is free to slide longitudinally. Each of the slide elements has spaced slots formed longitudinally thereof, at least certain portions of the slots aligning during the full range of relative motion between the slide elements to allow fastening members, such as a bolt and winged nut, to be extended through the slots to secure the slide elements together in a desired lengthwise relation. The blade members at opposed ends of each support member are tilted toward the rear of said support member to cause the body of the support member to be spaced from the window glass or other surface surmounted thereby. A rifle or other firearm thus placed in the cradle members formed on one of the slide elements is thereby releasably held in spaced relation from a window glass or wall surface. Accordingly, it is an object of the invention to provide an improved mounting rack for rifles and similar firearms which can be mounted in combination with a window assembly of a vehicle. It is another object of the invention to provide a mounting rack for rifles or other elongated items which can be easily installed between the molding and glass pane of a window in a vehicle, the mounting rack being readily adjustable to window assembly widths within a full range encompassing distances less than to greater than the length of support members comprising the mounting rack. It is a further object of the invention to provide a mounting rack which can be mounted between vertically spaced brackets on a wall or other supporting structure. These together with other objects and advantages which will become subsequently apparent reside in the details of 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. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the present mounting rack in an assembled configuration; FIG. 2 is an elevational view in partial section taken along line 2--2 of FIG. 1; FIG. 3 is a sectional view taken along line 3--3 of FIG. 1; FIG. 4 is a sectional view taken along line 4--4 of FIG. 3; FIG. 5 is an idealized assembly view in perspective of the two major structural elements comprising the invention; FIG. 6 is a perspective view of one embodiment of a mounting bracket alternately useful with the invention; FIG. 7 is a perspective view of a second embodiment of a mounting bracket; and FIG. 8 is a perspective view of a third embodiment of a mounting bracket. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings and particularly to FIG. 1, the present gun mounting rack is seen generally at 10 to comprise two identical support members 12, the support members 12 being spaced laterally apart a distance sufficient to allow mounting therebetween of a rifle, such as rifle 14 shown in phantom. The support members 12 are each mounted to a suitable surface at upper and lower ends thereof as will be further described hereinafter. Since the support members 12 are identical in structure and operation, a description of one will suffice for disclosure of the features of both. Accordingly, as further seen in FIGS. 2 and 5, each support member 12 is seen to be comprised of slide elements 16 and 18, the slide element 16 comprising a U-shaped track bounded by a rear wall 20 and side walls 22 connected to said wall 20 and extending perpendicularly thereto. The side walls 22 each have at least two elongated slots 24 disposed therein and lying along vertical edges 26, the slots 24 being laterally aligned with each other. The side walls 22 extend beyond lower edge 28 of the rear wall 20 and curve laterally therefrom to form curved wall portions 30, the curved portions 30 terminating at the intersections of the curved edges respectively defining said portions with the vertical edges 26. The curved portions 30 thus extend vertically downwardly when the support members 12 are mounted to perform a function to be described hereinafter. The rear wall 20 at the upper end of the slide element 16 laterally expands along each side thereof to form a blade member 32, the blade member 32 extending rearwardly of the plane of the rear wall 20, the plane in which said blade member 32 lies being disposed at a slight angle to the plane of the rear walls 20. Upper edges 34 of the side walls 22 of the slide element 16 extend essentially from the juncture of the rear wall 20 and the blade member 32 at an angle to the rear wall 20 to intersect the vertical edges 26 and thus form pointed tongues 36. The tongues 36 can be used as a mounting for a hat or article of clothing when the support members 12 are installed on a support structure. The slide element 16 is preferably formed of metal due to the heavyduty use of the U-shaped track formed by the walls 20 and 22, the slide element 18 fitting within the open-sided track channel defined by said walls and being vertically movable therewithin. The slide element 18, as can also be seen in FIG. 3, has a rear wall 38 which is connected to a central bar member 40 by a vertical structural element 42, the element 42 extending perpendicularly to spaced parallel walls of the rear wall 18 and central bar member 40 and connecting thereto along the respective lengths thereof. The bar member 40 has a plurality of elongated slots 44 formed therethrough and extending between parallel side walls of said bar member 40, the slots 44 being spaced vertically along the bar member 40. A web portion 46 extends from the forward wall surface of the bar member 40 to form curved cradle members 48, two of the cradle members 48 being preferably disposed in vertically spaced relation forward of the bar member 40. The upper end of the slide element 18 curves slightly from the rear wall 38 to intersect with the rear portion of the upper cradle member 40. The lower end of the slide element 18 has an enlarged blade member 50 extending from the rear wall 38, the plane in which the blade member 50 lies being disposed at a slight angle to the plane of the rear wall 38. The lower edge of the slide element 18 extends normally from the rear wall 38 and then extends upwardly at an angle to intersect the lower edge of the bar member 40 and to define the lower edge of the web portion 46, said lower edge terminating at its intersection with a lower curved portion of the lowermost cradle member 48. As can be seen in the drawings and particularly in FIGS. 3 and 4, split oval shaped resilient pads 52 are received on flanges 54 which extend laterally from the major body portions of the cradle members 48, the flanges 54 essentially being continuous about the periphery of the cradle members 48 and of the web portion 46. The pads 52 prevent scratching or marring of the finish of a rifle placed within the cradle members 48. The slide element 18 is dimensioned such that it can be slidably received within the U-shaped track formed by the slide element 16. When the slide elements 16 and 18 are thus brought together, at least portions of the slots 24 and 44 respectively disposed in said elements 16 and 18 align regardless of the relative vertical positions of the slide elements 16 and 18. Further, except when the upper end of the slide element 18 is substantially displaced into a juxtaposed relationship with the lower edge 28 of the rear wall 20 of the element 16, at least two spaced aligned apertures are formed by the slots 24 and 44 laterally through the support member 12. Therefore, two bolts 56 can be inserted through the aligned slots 24 and 44 and secured by wing nuts 58 to hold the slide elements 16 and 18 together in a desired relative position. Therefore, as is seen in FIG. 1, the blade members 32 and 50 can be inserted into recesses formed in mounting brackets 60 or can be fitted between the molding surrounding a window in a vehicle and the glass pane itself such as is described in U.S. Pat. No. 3,876,079. When mounted to a wall such as is shown in FIG. 1, the brackets 60 are vertically spaced at a desired distance, the distance often being dictated by the location of suitable structure on which to secure the brackets 60. The brackets 60, forms of which are shown in FIGS. 6, 7, and 8, provide facing recesses defining by structural tabs or curved portions and the like which receive the blade members 32 and 50 therewithin, the slide elements 16 and 18 being extended (or contracted) relative to each other to fit in the brackets 60. The slide elements 16 and 18 are then bolted together as aforesaid. As particularly shown in FIG. 2, the rear wall 20 of the slide element 16 is caused to be spaced from the surface surmounted by the support member 12. Due to the rearward tilt of the blade members 32 and 50, the support members 12 are caused to remain out of contact with the surface surmounted thereby. Thus, when the rack 10 is mounted across a window such as in a vehicle, no load is transmitted from the body of the support members 12 to the window glass. The support members 12 can be mounted across distances ranging from less than the length of the slide member 18 alone to a length of nearly the combined lengths of the two slide elements 16 and 18. In particular, the shorter length of the rear wall 20 relative to the side walls 22 allows the blade member 50 of the slide element 18 to abut the lower edge 28 of the rear wall 20 while the slots 24 in the extended side walls 22 (extended by the structural curved portion 30) extend beyond this point of abutment. This structural feature allows mount of the support members 12 between brackets 60 or moldings which are spaced oppositely apart by a distance equal to the vertical lengths of the blade members 32 and 50 and the length of the rear wall 20 of the slide lement 16. This distance is a minimum mounting spacing not heretofore obtainable. 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.

1a

FIELD OF THE INVENTION [0001] The present application relates to a technical field of an electronic cigarette, and more particularly relates to an electronic cigarette and an atomization control method thereof. BACKGROUND OF THE INVENTION [0002] In the prior art, electronic cigarettes generally comprise two parts which are an atomization assembly for atomizing e-liquid and a battery assembly for supplying power to the atomization assembly. Among them, an existing electronic cigarette integrated an airflow sensor with a control circuit to control the electronic cigarette, when the user smoking electronic cigarette, the electronic cigarette air pressure will change, resulting in deformation of a thin film capacitor of the airflow sensor. When the amount of the deformation of the thin film capacitor reaches a threshold, a trigger signal is sent to the microprocessor in the control circuit to ensure the microprocessor to control the battery assembly to supply power to the atomization assembly to atomize e-liquid. [0003] However, such an electronic cigarette in a packaging or transport process, is prone to cause a change of the air pressure in the electronic cigarette, which causes the electronic cigarette to work automatically. The electronic cigarette automatically working for a long time is likely to cause a risk of fire and explosion, while the electronic cigarette automatically working for a long time leads to a problem that deterioration and taste of the atomized e-liquid are changed after the atomized e-liquid is repeatedly oxidized by the air. [0004] Another existing electronic cigarette is to replace the airflow sensor through a mechanical key switch to control the electronic cigarette to achieve an atomization of the liquid. Because a frequency of pressing the key switch is high when smoking the electronic cigarette, the key switch is likely to fail during a long pressing process, then some electronic cigarettes are controlled by using touch switches instead of the above key switches. However, a touch switch is usually provided at a certain position on an outer peripheral surface of the battery assembly, and as long as the touch switch is touched, the electronic cigarette is operated, it is easy to touch the touch switch when packaging or holding the electronic cigarette, thereby leading to an automatic work situation of the electronic cigarette. SUMMARY OF THE INVENTION [0005] Technical problems to be solved in the present invention is to provide an electronic cigarette and an atomization control method thereof aiming at defects in the prior art. [0006] A technical proposal for solving the technical problem of the invention is shown as following. [0007] Provide an electronic cigarette comprising an atomization assembly and a battery assembly, a heating wire assembly is defined in the atomization assembly, the battery assembly is provided with a power source for supplying electrical power to the heating wire assembly so that the atomization assembly atomizes e-liquid to form smoke; the electronic cigarette further comprises a control module electrically connected to the power source and the heating wire assembly, respectively, and an airflow sensor configured for transmitting a smoking signal to the control module when the airflow sensor detects that a user is smoking; a first conductor is provided on an outer peripheral surface of the battery assembly; a suction nozzle for a user to smoke is provided on an end of the atomization assembly opposite to the battery assembly; and a second conductor is provided on an outer peripheral surface of the suction nozzle; one conductive sleeve of the first conductor and the second conductor is electrically connected to the control module and the other conductor is electrically connected to the power source; [0008] The first conductor and the second conductor are contacted and then conducted by the user's skin while the user is smoking, the control module is configured for controlling the power source to supply the electrical power to the heating wire assembly to atomize the e-liquid when the control module detects the smoking signal and a conduction signal generated by that the first conductor and the second conductor are conducted. [0009] In the electronic cigarette according to the present invention, the atomization assembly comprises an e-liquid cup assembly, the e-liquid cup assembly comprises an e-liquid reservoir and a vent pipe, the vent pipe is inserted in the e-liquid reservoir and configured for discharging smoke atomized by the atomization assembly from the suction nozzle, one end of the e-liquid cup assembly is provided with the suction nozzle made of a conductive material, an outer surface of the suction nozzle is configured as the second conductor, the other end of the e-liquid cup assembly is provided with an atomization core for atomizing the e-liquid, at least one end of the atomization core is inserted into the e-liquid cup assembly. [0010] One end of the atomization core is connected to the vent pipe, the other end of the atomization core is connected with the battery assembly, the control module is defined in the battery assembly, two ends of the vent pipe are electrically connected to the suction nozzle and the atomization core, respectively, the suction nozzle is electrically connected to the control module via the vent pipe and the atomization core. [0011] In the electronic cigarette according to the present invention, a smoke passage and an elastic conductive arm are defined in the atomization core, the smoke passage is communicated with the vent pipe, the elastic conductive arm extends into the smoke passage are defined in the atomization core, the elastic conductive arm is electrically connected to the control module, the vent pipe is inserted into the smoke passage, the elastic conductive arm is abutted against a side wall of the vent pipe. [0012] In the electronic cigarette according to the present invention, the atomization core further comprises a hollow atomization seat; the smoke passage is defined in the atomization seat, a side wall of the atomization seat is provided with an e-liquid entering channel communicated with an e-liquid storage cavity in the e-liquid cup assembly, the heating wire assembly is defined on the smoke passage; an end of the atomization seat is connected with an atomization electrode assembly configured for being electrically connected to the battery assembly. [0013] In the electronic cigarette according to the present invention, the battery assembly comprises the first conductive sleeve configured as the first conductor, the first conductive sleeve receives a battery configured as the power source, one end of the first conductive sleeve is provided with a first connector for being detachably connected the atomization assembly, the other end of the first conductive sleeve is provided with an end cap configured for covering the first conductive sleeve. [0014] In the electronic cigarette according to the present invention, the battery assembly comprises a battery case, the first conductor is a first conductive sleeve made of a conductive paper, the first conductive sleeve is sleeved on the battery case and covers an entire outer peripheral surface of the battery case, the battery case receives a battery configured as the power source, one end of the battery case is provided with a first connector for being detachably connected the atomization assembly, the other end of the battery case is provided with an end cap configured for covering the first conductive sleeve. [0015] In the electronic cigarette according to the present invention, an outer peripheral surface of the atomization assembly is provided with an insulating paper sleeve defined coaxially with the first conductor, the insulating paper sleeve is located between the first conductor sleeve and the second conductor. [0016] In the electronic cigarette according to the present invention, the battery assembly and the atomization assembly are detachably connected, and the detachable connection between the battery assembly and the atomization assembly is a threaded connection structure or an interlocking connection structure. [0017] In the electronic cigarette according to the present invention, the control module comprises a conductive sleeve conduction signal detection circuit, a microprocessor, a transistor switch unit, the transistor switch unit is electrically connected to the microprocessor and the heating wire assembly; [0018] The conductive sleeve conduction signal detection circuit is configured for detecting whether or not the first conductive sleeve and the second conductor are conducted, and transmitting a trigger signal generated after the conduction to the microprocessor, the microprocessor is configured for controlling an on/off state of the transistor switch unit in accordance with the trigger signal and the smoking signal which is outputted by the airflow sensor to control whether the atomization assembly atomizes the e-liquid. [0019] In the electronic cigarette according to the present invention, the conductive sleeve conduction signal detection circuit comprises a filter circuit electrically connected to the second conductor for filtering an inputted conduction signal, and a transistor switching circuit electrically connected an output end of the filter circuit, the transistor switching circuit is configured to receive the conduction signal after filtering and output a switching signal to the microprocessor. [0020] In the electronic cigarette according to the present invention, the filter circuit comprises a first resistor, a second resistor, a first capacitor and a second capacitor, a common terminal of the first resistor, the first capacitor and the second capacitor is grounded, the other end of the first resistor, the other end of the first capacitor and one end of the second resistor are electrically connected to the second conductor, the other end of the second resistor and the other end of the second capacitor are connected to the transistor switching circuit. [0021] In the electronic cigarette according to the present invention, the transistor switching circuit comprises a first transistor, a second transistor, a third resistor, a fourth resistor and a fifth resistor; a base of the first transistor is connected with the filter circuit, an emitter of the first transistor is grounded, a collector of the first transistor is connected to one end of the third resistor and one end of the fourth resistor, the other end of the third resistor is electrically connected to the power source, and the other end of the fourth resistor is connected to a base of the second transistor, an emitter of the second resistor is electrically connected to the power source, a collector of the second resistor is electrically connected to one end of the fifth resistor and the microprocessor, and the other end of the fifth resistor is grounded. [0022] In the electronic cigarette according to the present invention, the conductive sleeve conduction signal detection circuit comprises a filter circuit electrically connected to the second conductor for filtering an inputted conduction signal, and a comparison circuit electrically connected to an output terminal of the filter circuit, a positive input terminal of the comparison circuit receives the conduction signal after filtering and outputs a comparison result signal to the microprocessor. [0023] In the electronic cigarette according to the present invention, the battery assembly is provided with a battery configured as the power source; one conductive sleeve selected from both the first conductive sleeve and the second conductor is electrically connected to a positive electrode of the battery. [0024] In the electronic cigarette according to the present invention, the atomization assembly and the battery assembly are arranged coaxially. [0025] The present invention further provides an atomization control method of an electronic cigarette, the electronic cigarette comprises an atomization assembly and a battery assembly, a heating wire assembly is defined in the atomization assembly, the battery assembly is provided with a power source for supplying electrical power to the heating wire assembly so that the atomization assembly atomizes e-liquid to form smoke; the electronic cigarette further comprises a control module electrically connected to the power source and the heating wire assembly respectively, and an airflow sensor configured for transmitting a smoking signal to the control module when the airflow sensor detects that a user is smoking; a first conductor is provided on an outer peripheral surface of the battery assembly; a suction nozzle for a user to smoke is provided on an end of the atomization assembly opposite to the battery assembly; and a second conductor is provided on the outer peripheral surface of the suction nozzle; the control method comprises following steps. [0026] S1. conducting the first conductor and the second conductor with user's skin when the user contacts the first conductor and the second conductor with the skin simultaneously, so as to generate a conduction signal to the control module; [0027] S2. controlling the power source to supply the electrical power to the heating wire assembly to atomize e-liquid when the control module receives the conduction signal and a smoking signal, the conduction signal is generated by that the first conductor and the second conductor are conducted. [0028] Generally, applications of the electronic cigarette and the atomization control method thereof of the present invention have following advantages, the first conductor is provided on the outer peripheral surface of the battery assembly, and the outer peripheral surface of the suction nozzle is provided with a second conductor, when smoking, the user directly holds on the first conductor by fingers and holds on the suction nozzle by a mouth, so as to realize contacts between the conductive sleeves at different positions on the outer surface of the electronic cigarette and the user's skin at the same time, and to transmit the conduction signal to the control module, meanwhile the airflow sensor is triggered, then the airflow sensor outputs a smoking signal to the control module, the control module controls the power source to supply the heating wire assembly to atomize the e-liquid and start the electronic cigarette working after receiving the conduction signal and the smoking signal. [0029] Therefore, the present invention can reduce a probability that the electronic cigarette is mistakenly triggered, effectively solves the problem in the prior art that the electronic cigarette works when the key switch, the touch switch or the airflow sensor is often mistakenly triggered, resulting in a change of deterioration of taste of the e-liquid of the electronic cigarette caused by repeated oxidization, a short electronic cigarette life, low safety and other issues. Moreover, by providing the structure of the present invention, it is possible to reduce conditions of the packaging apparatus for transporting the electronic cigarette, thus to facilitate the transportation and the transportation is more secure. In addition, during a using process, the structure meets user habits that the user can smoke when the fingers are held on the battery assembly and the mouth is held on the suction nozzle, it is more user-friendly, improves user experience, so as to avoid a complex using problem that the touch keys or switches are needed to be touched in the prior art. BRIEF DESCRIPTION OF THE DRAWINGS [0030] The present invention will be further described with reference to the accompanying drawings and embodiments in the following. [0031] FIG. 1 is an explosion view of an electronic cigarette provided by one of the preferred embodiments of the present invention; [0032] FIG. 2 is a cross-sectional view of the electronic cigarette shown in FIG. 1 ; [0033] FIG. 3 is a structural schematic view of the battery assembly of the electronic cigarette shown in FIG. 1 ; [0034] FIG. 4 is a structural schematic view of the atomization core of the atomization assembly in the electronic cigarette shown in FIG. 1 ; [0035] FIG. 5 is an explosion view of the atomization core in FIG. 4 ; [0036] FIG. 6 is a schematic view of the structure of the fixing block of the atomization core shown in FIG. 5 ; [0037] FIG. 7 is a structural schematic view of the electronic cigarette provided by a second preferred embodiment of the present invention; [0038] FIG. 8 is a schematic view of the structure of the fixing block of the atomization core shown in FIG. 7 ; [0039] FIG. 9 is a structural diagram of the control module of the electronic cigarette shown in FIG. 1 ; [0040] FIG. 10 is a configuration diagram of the conductive sleeve conduction signal detection circuit of a first kind of the control module shown in FIG. 9 ; [0041] FIG. 11 is a configuration diagram of the conductive sleeve conduction signal detection circuit of a second kind of the control module shown in FIG. 9 ; [0042] FIG. 12 is a circuit diagram of a first kind of the control module shown in FIG. 9 ; [0043] FIG. 13 is a circuit diagram of a second kind of the control module shown in FIG. 9 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0044] To make the technical feature, objective and effect of the present application be understood more clearly, now the specific implementation of the present application is described in detail with reference to the accompanying drawings and embodiments. [0045] FIG. 1 and FIG. 2 show an electronic cigarette provided by one of the preferred embodiments of the present invention, the electronic cigarette comprises an atomization assembly 1 and a battery assembly 5 , the battery assembly 5 is electrically connected to the atomization assembly 1 and is configured for supplying electrical power to the atomization assembly 1 , the atomization assembly 1 and the battery assembly 5 are co-axially defined. The atomization assembly 1 comprises a suction nozzle 2 , an e-liquid cup assembly 3 and a atomization core 4 which are connected successively, the suction nozzle 2 and the atomization core 3 are respectively connected to two ends of the e-liquid cup assembly 3 , and the battery assembly 5 is connected to one end of the atomization core 4 opposite to the suction nozzle 2 . [0046] As shown in FIGS. 3-4 , a heating wire assembly 42 is defined in the atomization assembly 1 , the battery assembly 5 is provided with a power source for supplying electrical power to the heating wire assembly 42 so that the atomization assembly 1 atomizes e-liquid to form smoke. The electronic cigarette further comprises a control module 53 electrically connected to the power source and the heating wire assembly 42 , respectively, and an airflow sensor 54 configured for transmitting a smoking signal to the control module 53 when the airflow sensor 54 detects that a user is smoking. [0047] As shown in FIG. 1 , a first conductor 51 is provided on an outer peripheral surface of the battery assembly 5 , a suction nozzle 2 for a user to smoke with is provided on an end of the atomization assembly 1 opposite to the battery assembly 5 ; and a second conductor 21 is provided on an outer peripheral surface of the suction nozzle 2 ; one conductor of the first conductor 51 and the second conductor 21 is electrically connected to the control module 53 and the other conductor is electrically connected to the power source, so that an electrical potential of the conductor electrically connected to the power source is higher than an electrical potential of the conductor electrically connected to the control module 53 . Therefore, the conductor electrically connected to the power source can be directly or indirectly electrically connected to the power source, as long as the potential of the conductor is higher than the potential of the conductor electrically connected to the control module 53 . [0048] When the user is smoking, the user contacts the first conductive sleeve and the second conductor 21 through skin, respectively, so that the first conductive sleeve and the second conductor 21 are conducted, the control module 53 controls the power source to supply the electrical power to the heating wire assembly 42 to atomize the e-liquid when the control module 53 receives a conduction signal and a smoking signal, the conduction signal is generated by that the first conductive sleeve and the second conductor 21 are conducted. [0049] In the present embodiment, the second conductor 21 is provided at the suction nozzle 2 of the electronic cigarette, the first conductor 51 is provided on the outer peripheral surface of the battery assembly 5 , namely, only when the user skin contacts with the first conductor 51 and the second conductor 21 , the first conductor 51 and the second conductor 21 are turned on, meanwhile, the airflow sensor 54 outputs a signal, then the electronic cigarette is triggered to atomize, the electronic cigarette operates normally, effectively avoiding a defect of an automatically started electronic cigarette in packages during a process of transporting the electronic cigarette. [0050] As shown in FIG. 1 , the first conductor 51 and the second conductor 21 are spaced apart from each other on an outer peripheral wall of the electronic cigarette, and the first conductor 51 is located on the outer peripheral wall of the battery assembly 5 , the second conductor 21 is defined on the outer surface of the suction nozzle 2 . [0051] Preferably, the first conductor 51 and the second conductor 21 are made of a metal conductive material, so that the structure of the electronic cigarette is reliable. The metal material may be a material such as gold, silver, copper, iron or stainless steel, and is not particularly limited thereto. [0052] As shown in FIG. 3 , the battery assembly 5 comprises the first conductor 51 , the first conductor 51 is a hollow cylindrical structure, and receives a battery 52 configured as the power source, one end of the first conductor 51 is provided with a connector 55 for being detachably connected the atomization core 4 , the other end of the first conductor 51 is provided with an end cap 56 configured for covering the first conductive sleeve. Since the user normally holds on the battery assembly 5 by fingers at the smoking time, the structure is not only simple and compact, but also allows the user to well contact with the first conductor 51 during using, and it prevents the first conductor 51 defined at one point of the battery assembly 5 from being difficultly to be contacted with. [0053] Understandably, in other embodiments, the battery assembly 5 comprises a battery case (not labeled in drawings), the first conductor 51 is a first conductive sleeve made of a conductive paper (not shown in drawings), the first conductive sleeve is sleeved on the battery case and covers an entire outer peripheral surface of the battery case, and the battery case receives a battery 52 configured as the power source, one end of the first conductive sleeve is provided with a connector 55 for being detachably connected the atomization core 4 , the other end of the first conductive sleeve is provided with an end cap 56 configured for covering the first conductive sleeve. The present embodiment does not limit a specific structure of the first conductor 51 as long as it can be provided on the outer peripheral surface of the battery assembly 5 and is electrically connected to the control module 53 or the battery 52 of the electronic cigarette. The conductive paper can not only imitate a real cigarette, but also improve the user's comfort. [0054] As shown in FIG. 2 , the atomization assembly 1 comprises the suction nozzle 2 , the e-liquid assembly 3 and the atomization core 4 , the suction nozzle 2 and the atomization core 4 are defined at two ends of the e-liquid assembly 3 , respectively. The second conductor 21 is sleeved on the outer peripheral surface of the suction nozzle 2 . By providing the second conductor 21 on the suction nozzle 2 , it is possible to make it easy for the user to ensure that the second conductor 21 comes into contact with the user's skin when the user is smoking, and then it is more convenient for the user to use and thereby improves the user's experience. [0055] It is preferred that the second conductor 21 is coated on an entire outer peripheral surface of the suction nozzle 2 . [0056] Preferably, the second conductor 21 is spaced apart from the first conductor 51 in the battery assembly 5 to ensure an electrical insulation between the first conductor 51 and the second conductor 21 . In the present embodiment, the first conductor 51 and the second conductor 21 are respectively provided at two ends of the e-liquid cup assembly 3 , and the outer peripheral surface of the e-liquid cup assembly 3 is made of an insulating material to achieve an electrical isolation between the first conductor 51 and the second conductor 21 . [0057] Preferably, an outer peripheral surface of the e-liquid cup assembly 3 is provided with an insulating paper sleeve (not shown in drawings) defined coaxially with the first conductor 51 and the second conductor 21 , the insulating paper sleeve is located between the first conductor 51 and the second conductor 21 . [0058] When the user smokes, the skin comes into contact with the first conductor 51 and the second conductor 21 so that the first conductor 51 and the second conductor 21 are conducted, and the control module 53 controls the power supply to supply the electrical power to the heating wire assembly 42 to atomize the e-liquid to enable the electronic cigarette to operate normally after receiving the conduction signal and the smoking signal, the conduction signal is generated by that the first conductor 51 and the second conductive are conducted. [0059] Specific structures of the e-liquid cup assembly 3 and the suction nozzle 2 of the atomization assembly 1 will be described in detail with reference to the embodiments shown in FIGS. 1-2 . [0060] As shown in FIG. 2 , the atomization assembly 1 comprises an e-liquid reservoir 31 , a vent pipe 32 , an e-liquid storage cavity 33 and a connecting member 34 . [0061] The e-liquid reservoir 31 has a substantially cylindrical structure, and the atomization core 4 and the suction nozzle 2 are respectively connected to two ends of the e-liquid reservoir 31 , the vent pipe 32 is provided in the e-liquid reservoir 31 in an axial direction of the e-liquid reservoir 31 , and the e-liquid storage cavity 33 is formed between the e-liquid reservoir 31 and the vent pipe 32 , and the e-liquid for being atomized by the atomization core 4 is received in the e-liquid storage cavity 33 . In order to facilitate the user to view the remaining amount of the e-liquid in the e-liquid storage cavity 33 , in the present embodiment, the e-liquid reservoir 31 is made of a light-permeable material. [0062] The vent pipe 32 is made of a conductive material and two ends of the vent pipe 32 are inserted into the suction nozzle 2 and the atomization core 4 , respectively, an airflow passage is surrounded in the inside of the vent pipe 32 for flowing the airflow to the suction nozzle 2 , and the e-liquid storage cavity 33 for storing the e-liquid is formed between the vent pipe 32 and the e-liquid reservoir 31 . [0063] The connecting member 34 is fixed at one end of the e-liquid reservoir 31 for connection to the atomization core 4 , and the atomization core 4 is detachably connected to the connecting member 34 . In the present embodiment, the detachable connection between the connecting member 34 and the atomization core 4 is a threaded connecting structure, the connecting member 34 is provided with an internal thread at a position to be connected to the atomization core 4 , an outer face of the atomization core 4 is provided with an external thread matched with the internal thread. If other detachable connecting structures are taken between the atomization core 4 and the connecting member 34 , other connecting structures may be provided on the connecting member 34 , such as a snap-on elastic piece having elasticity in a snap connection, and in the present embodiment, the threaded connecting connection is taken for an example, and it is not limited to the threaded connecting connection. [0064] As shown in FIG. 1 , an outer end surface of the suction nozzle 2 is provided with a second conductor 21 , and the second conductor 21 is electrically connected to the vent pipe 32 . The suction nozzle 2 is fixed at one end of the e-liquid reservoir 31 , the end of the e-liquid reservoir 31 is opposite to the battery assembly 5 . Two ends of the vent pipe 32 are inserted into the suction nozzle 2 and the atomization core 4 , respectively, and an air outlet (not labeled in figures) communicating with the vent pipe 32 is provided in the suction nozzle 2 , the smoke generated by the atomization core 4 sequentially passes through the vent pipe 32 and the air outlet for the user to inhale. [0065] Preferably, the outer end surface of the suction nozzle 2 is spherical so that the suction nozzle 2 is beautiful and the outer end surface of the nozzle 2 is easy to clean dirt. In addition, since the suction nozzle 2 having a spherical outer end surface which is structurally stable, it is possible to prevent the suction nozzle 2 from being easily deformed and falling down when a hard object such as teeth in the mouth is held on the suction nozzle 2 . [0066] Preferably, the suction nozzle 2 is a metallic material and can prevent the suction nozzle 2 from being easily peeled off when the hard object such as the teeth of the mouth is held on the e-liquid reservoir 31 . In this case, the metal may be copper, iron or steel, and is not particularly limited thereto. [0067] The embodiment of the atomization core 4 of the atomization module 1 will be described in detail with reference to the embodiment shown in FIGS. 1, 2, 4, 5 and 6 . [0068] As shown in FIG. 4 , the atomization core 4 mainly comprises an atomization seat 41 , a heating wire assembly 42 , a fixing block 43 , an atomization cover 44 , an electrode holder 45 , and an atomization electrode assembly 46 . [0069] The atomization seat 41 is generally a hollow structure in which an air passage 32 is formed, the air passage 32 is communicated with the e-liquid cup assembly 3 , and a side wall of the atomization seat 41 is provided with an e-liquid entering channel communicating with the e-liquid storage cavity 33 . The heating wire assembly 42 is provided in the smoke passage and the smoke generated by the atomization of the heating wire assembly 42 is discharged from the vent pipe 32 through the smoke passage. [0070] Specifically, the atomization seat 41 is made of a conductive material which comprises a first base body 411 and a second base body 412 connected to each other, and the first base body 411 and the second base body 412 are in interference fit. The first base body 411 is defined on one side of the atomization seat 41 close to the suction nozzle 2 and is in a plug connection with the vent pipe 32 . The second base body 412 is defined on the other side of the atomization seat 41 close to the battery assembly 5 and is detachably connected to the battery assembly 5 . [0071] As shown in FIG. 5 , an outer wall of the first base body 411 is provided with an external thread structure detachably connected to the connecting member 34 of the e-liquid cup assembly 3 . The first base body 411 is provided with an installing groove 413 at one end thereof close to the suction nozzle 2 , and the heating wire assembly 42 is provided in the installing groove 413 . In the present embodiment, the installing groove 413 comprises two, two installing grooves 413 are spaced apart from each other and are in communication with the e-liquid storage cavity 33 of the e-liquid cup assembly 3 , the e-liquid adsorbent 421 of the heating wire assembly 42 is installed and fixed at a bottom of the installing grooves 413 and extends into the e-liquid storage cavity 33 . Further, the two installing grooves 413 constitute the e-liquid entering channel inside the atomization seat 41 , and the e-liquid in the e-liquid storage cavity 33 is absorbed by the e-liquid adsorbent 421 through the e-liquid entering channel. [0072] The heating wire assembly 42 comprises the e-liquid adsorbent 421 and an heating wire 422 (as shown in FIG. 4 ), the e-liquid adsorbent 421 is made of an e-liquid absorbing material which is fixed to the bottom of the installing grooves 413 and two ends of the e-liquid adsorbents 421 extend into the e-liquid storage cavity 33 , the heating wire 422 is wound around the e-liquid adsorbent 421 and electrically connected to the battery assembly. Since the heating wire assembly 42 is a conventional means of the prior art, a specific structure thereof will not be described here. [0073] The fixing block 43 is substantially a ring-shaped structure which is embedded and fixed to an inner wall of one end of the first base body 411 close to the suction nozzle 2 . As shown in FIG. 4 , an elastic conductive arm 431 extending to the smoke passage of the atomization 4 is fixed on the fixing block 43 . The vent pipe 32 is inserted in the smoke passage and a side wall of the elastic conductive arm 431 and a side wall of the vent pipe 32 are resiliently abutted against and electrically connected to each other. [0074] Further, the elastic conductive arm 431 is electrically connected to the atomization electrode assembly 46 , as shown in FIG. 6 , the elastic conductive arm 431 is provided with a perforation 432 provided with an electric wire (not shown in figures), one end of the electric wire is connected to the elastic conductive arm 431 and the other end of the electric wire is connected to the atomization electrode assembly 46 so that the elastic conductive arm 431 is electrically connected to the atomization electrode assembly 46 . Since the elastic conductive arm 431 is electrically connected to the vent pipe 32 and the suction nozzle 2 , respectively, thereby achieving that the atomization electrode assembly 46 is electrically connected to the vent pipe 32 and the suction nozzle 2 . [0075] The atomization cover 44 is provided with a receiving chamber (not labeled in figures) in an axial direction, and one end of the atomization cover 44 opposite to the suction nozzle 2 is sleeved on the first base body 411 and abuts against the heating wire assembly 42 to prevent the heating wire assembly 42 from being rocked. The vent pipe 32 (shown in FIG. 3 ) is inserted from one end of the atomization cover 44 close to the suction nozzle 2 and is in interference with a side wall of the receiving chamber. [0076] Further, in order to prevent the e-liquid leaking from a connection of the vent pipe 32 with the atomization cover 44 , a sealing ring (not labeled in figures) set on the vent pipe 32 may be provided in the receiving chamber of the atomization cover 44 , an outer peripheral surface of the seal ring is elastically abutted against a side wall of the receiving chamber, and an inner peripheral surface of the seal ring is elastically abutted against an outer peripheral wall of the vent pipe 32 to achieve as a sealing function. [0077] As shown in FIG. 5 , the second base body 412 is generally a hollow cylindrical structure which is in a plug connection with and is in an interference fit with the first base body 411 , a side of the second base body 412 close to the battery assembly 5 is detachably connected to the battery assembly 5 . In the present embodiment, the detachable connection between the second base body 412 and the battery assembly 5 is a screw connection structure, and one side of the second base body 412 close to the battery assembly 5 is provided with an external thread structure, a connection position of the battery assembly 5 which is configured for being connected with the second base body 412 is provided with an internal thread structure adapted to the external thread structure. If other detachable connection structures are taken between the battery assembly 5 and the second base body 412 , other detachable connection structures may be provided on the second base body 412 , for example, a snap-in elastic piece having an elasticity in a snap connection, a buckle or a slot in an interlocking structure, etc. In this embodiment, only a screw connection structure is described as an example, and is not limited to a screw connection structure. [0078] The electrode holder 45 is made of an insulating material and is fixed in the second base body 412 . The electrode holder 45 is provided with a vent hole 451 communicating with the vent pipe 32 . As shown in FIG. 4 , the atomization electrode assembly 46 is fixed inside the electrode holder 45 . [0079] The atomization electrode assembly 46 is fixed on the electrode holder 45 , and one end of the atomization electrode assembly 46 is electrically connected to the elastic conductive arm 431 through an electric wire, and the other end of the atomization electrode assembly 46 is electrically connected to the battery assembly 5 . Specifically, the atomization electrode assembly 46 comprises a third electrode 461 and a fourth electrode 462 , and the third electrode 461 and the fourth electrode 462 are both spring electrodes. The third electrode 461 is electrically connected to the elastic conductive arm 431 through an electric wire, and two ends of the heating wire 422 are electrically connected to the fourth electrode 462 and the atomization seat 41 , respectively. [0080] As shown in FIG. 4 , the spring electrode comprises a protective sheath (not labeled in figures), and the protective sheath is provided with a groove (not labeled in figures), a spring and an electrical connector (all are not labeled on the drawings) are slidably connected to the groove. Specifically, one end of the spring is fixed to the bottom of the recess and the other end of the spring is fixedly connected to the electrical connector so that the electrical connector is slidably connected to the groove. When the atomization core 4 is connected to the battery assembly 5 , the electrical connector is resiliently abutted against the battery electrode assembly 57 of the battery assembly 5 to electrically connect to the battery assembly 5 . [0081] Preferably, a non-slip knurled structure (not shown) may be provided on an outer surface of the second base body 412 in order to facilitate the user to rotate the atomization seat 41 when the atomization core 4 needs to be removed. [0082] It is preferable that an outer surface of the atomization seat 41 is provided with an air inlet hole 414 which communicates with the vent pipe 32 . In this embodiment, the air inlet hole 414 successively passes through an outer wall of the second base body 412 and an outer wall of the first base body 411 , and is communicated with the vent pipe 32 and the vent hole 451 on the electrode holder 45 . [0083] In the present embodiment, the atomization core 4 mainly comprises an atomization seat 41 , an heating wire assembly 42 , a fixing block 43 , an atomization cover 44 , an electrode holder 45 , and an atomization electrode assembly 46 . It is to be understood that the atomization core 4 of the present application is not limited to the above-described structure, but may be other structures as long as it can atomize the smoke e-liquid. [0084] A specific structure of the battery assembly 5 will be described in detail with reference to the embodiment shown in FIGS. 1, 2 and 3 . [0085] As shown in FIG. 3 , the battery assembly 5 comprises the first conductor 51 , the battery 52 , the control module 53 , the airflow sensor 54 , the connector 55 , the end cap 56 , and a battery electrode assembly 57 . [0086] The first conductor 51 is generally a hollow cylindrical structure, the battery 52 is received and fixed in the first conductor 51 , the battery 52 is mainly configured for supplying power needed by work to the atomization core 4 and the control module 53 . In the present embodiment, the first conductive sleeve is electrically connected to the power source, i.e., the first conductive sleeve is electrically connected to a positive electrode of the battery 52 . Certainly, the power source 22 may be realized by a high-energy capacitor or the like, and is not particularly limited thereto. [0087] The end cap 25 is fixed at one end of the first conductor 51 opposite to the suction nozzle 2 , an air hole (not labeled in figures) for the airflow to flow is defined on the end cap 25 . Preferably, the end cap 25 is made of a light-transmissive material. [0088] The connector 55 is made of a conductive material and is electrically connected to the atomization seat 41 of the atomization core 4 . The connector 55 is connected to one end of the first conductor 51 close to the atomization core 4 , and the connector 55 is detachably connected to the atomization seat 41 , and an inner wall of the connector 55 is provided with an internal thread structure for detachably connecting to the atomization seat 41 . [0089] The battery electrode assembly 57 is fixed to the connector 55 and is electrically connected to the atomization electrode assembly 46 of the atomization core 4 . Specifically, the battery electrode assembly 57 comprises a first electrode 571 , a first insulating sleeve 572 , a second electrode 573 , and a second insulating sleeve 574 which are sequentially connected from the inside to the outside. The third electrode 461 of the atomization electrode assembly 46 is elastically abutted against and electrically connected to the second electrode 573 , and the fourth electrode 462 is elastically abutted and electrically connected to the first electrode 571 . [0090] The control module 53 and the airflow sensor 54 are fixed in the first conductor 51 , respectively, the control module 53 is electrically connected to the airflow sensor 54 and the battery 52 , respectively. The airflow sensor 54 is mainly used for detecting an airflow signal and generating a pulse signal, the control module 53 is mainly used for receiving the signal from the airflow sensor 54 and receiving the trigger signal of the first conductor 51 and second conductor 21 , and the control module 53 controls the battery 52 to supply power to the atomization core 4 to atomize the e-liquid according to the trigger signal and the pulse signal. [0091] During an operation of the electronic cigarette, the second conductor 21 of the suction nozzle 2 is electrically connected to the elastic conductive arm 431 through the vent pipe 32 , and the elastic conductive arm 431 is electrically connected to the third electrode 461 of the atomization electrode assembly 46 through the electric wire, and the third electrode 461 is elastically abutted against and electrically connected to the second electrode 573 , the second electrode 573 is electrically connected to the control module 53 , while the control module 53 is electrically connected to the first conductor 51 , and when the human body skin contacts the first conductor and the second conductor 21 respectively, the above-described structure constitutes an electrical connection circuit. [0092] Further, one end of the heating wire 422 of the heating wire assembly 42 is electrically connected to the atomization seat 41 , the atomization seat 41 is screwed and electrically connected to the connector 55 , and the connector 55 is electrically connected to the control module 53 , and the control module 53 is electrically connected to the airflow sensor 54 by an electric wire, the airflow sensor 54 is electrically connected to the battery 52 through an electric wire, the battery 52 is connected to the first electrode 571 of the battery electrode assembly 57 through an electric wire, and the first electrode 571 is elastically abutted against and electrically connected to the fourth electrode 462 of the atomization electrode assembly 46 , and the fourth electrode 462 is electrically connected to the other end of the heating wire 422 to form an electrical connection circuit. [0093] Specifically, when the first conductor 51 and the second conductor 21 are contacted simultaneously through user's skin, the user's skin enables the first conductor 51 and the second conductor 21 to be conducted; the control module receives the conduction signal produced by that the first conductor 51 and the second conductor 21 are conducted, and detects the smoking signal generated by the airflow sensor 54 , the control module 53 controls the battery 52 to supply the electrical power to the atomization core 4 to atomize e-liquid according to the conduction signal and the smoking signal. [0094] As shown in FIG. 9 , the control module 53 comprises a conductive sleeve conduction signal detection circuit 531 , a microprocessor 532 , and a transistor switch unit 533 , the transistor switch unit 533 is electrically connected to the microprocessor 532 and the heater wire assembly 42 , respectively. [0095] The microprocessor 532 in the control module 53 may be set with a heating time parameter after conduction, for example, in the microprocessor 532 , heating time is 2 to 10 ms after receiving the conduction signal, and this time period is set for a main consideration of electrical contact problems, smokers do not have to keep pressing the two conductors, but only need to press instantly at the beginning to generate an instantaneous conduction signal, even without a conduction signal during the time period, a heating time can be maintained, it can overcome a problem that the heating atomization is immediately turned off after being conducted by the human body as a release of the user, so as to facilitate a use of the user. [0096] The conductive sleeve conduction signal detection circuit 531 is configured for detecting whether or not the first conductive sleeve and the second conductor 21 are conducted, and transmitting a trigger signal generated after conduction to the microprocessor 532 , meanwhile, the airflow sensor 54 detects an airflow signal and generates a pulse signal. The microprocessor 532 controls an on/off state of the transistor switch unit 533 in accordance with the trigger signal and the pulse signal to control whether the atomization core 4 atomizes the e-liquid. [0097] FIGS. 10 and 12 show a schematic structural view of the first control module 53 of the present embodiment, the conductive sleeve conduction signal detection circuit 531 comprises a filter circuit 534 and a transistor switching circuit 535 . The filter circuit 534 is electrically connected to the second conductor 21 and is configured for filtering an input conduction signal; the transistor switching circuit 535 is electrically connected an output end of the filter circuit 534 , the transistor switching circuit 535 is configured for receiving a sensing signal after filtering and outputting a switching signal configured as a trigger signal to the microprocessor 532 . [0098] Specifically, the filter circuit 534 comprises a first resistor R 1 , a second resistor R 2 , a first capacitor C 1 and a second capacitor C 2 , a common terminal of the first resistor R 1 , the first capacitor C 1 and the second capacitor C 2 is grounded, the other end of the first resistor R 1 , the other end of the first capacitor C 1 and one end of the second resistor R 2 are electrically connected to the second conductor 21 , the other end of the second resistor R 2 and the other end of the second capacitor C 2 are connected to the transistor switching circuit 535 . [0099] The transistor switching circuit 535 comprises a first transistor Q 1 , a second transistor Q 2 , a third resistor R 3 , a fourth resistor R 4 and a fifth resistor R 6 ; a base of the first transistor Q 1 is connected with the filter circuit, an emitter of the first transistor Q 1 is grounded, a collector of the first transistor Q 1 is connected to one end of the third resistor R 3 and one end of the fourth resistor R 4 , the other end of the third resistor R 3 is electrically connected to the power source, and the other end of the fourth resistor R 4 is connected to a base of the second transistor Q 2 , an emitter of the second transistor Q 2 is electrically connected to the power source, a collector of the second transistor Q 2 is electrically connected to one end of the fifth resistor R 6 and the microprocessor 532 , and the other end of the fifth resistor R 6 is grounded. [0100] The microprocessor 532 is applied as a microcontroller U 1 whose type is MC32P7010A0I, the transistor switch unit 533 comprises a field effect transistor Q 4 , the heating wire 422 is connected between P 1 and P 2 , J 3 is electrically connected to the first conductor 51 and electrically connected to the positive electrode of the battery 52 , J 4 is electrically connected to the second conductor 21 . During operation, a portion of the human body contacts the second conductor 21 , and the other portion of the human body contacts the first conductor 51 . A specific working principle of the circuit is as follows: when the human body is not in contact, a collector of the transistor Q 2 outputs a low level, that is, a signal SIG=logic 0; when someone contacts the first conductor 51 and the second conductor 21 , a signal is firstly filtered by the filter circuit 534 , then flows through the transistor Q 1 to turn on the transistor Q 1 , and then the transistor Q 2 is turned on, so that the signal SIG are changed into a high level, that is, the signal SIG=logic 1. When the microcontroller U 1 detects a signal changed from the low level to the high level, it is known that someone wants to smoke, the microcontroller U 1 waits for a signal of the airflow sensor U 2 until the airflow sensor U 2 has an activated high level, and the microcontroller U 1 controls the field effect transistor Q 4 to turn on, that is, an effective high level of the airflow sensor U 2 , and the signal SIG=logic 1 (i.e., the first conductor 51 and the second conductor 51 are brought into contact), the atomization assembly can operate. [0101] Through the above circuit, we have realized that when the human body contacts the first conductor 51 and the second conductor 51 , and the airflow sensor 54 also has an effective smoking signal, the electronic cigarette can work properly, avoiding that the situation of the electronic cigarette automatic work takes place in the packaging and transportation process. Due to the packaging or sealing of an electronic cigarette may cause air pressures on both sides of the airflow sensor 54 is different, resulting in the electronic cigarette automatic work; or in the transportation process, such as aircraft, automatic operation of the electronic cigarette may be caused by changes in air pressure, and the electronic cigarette automatic operation for a long time may cause a risk of fire and explosion, and affecting user experience effect. [0102] FIGS. 11 and 13 show a schematic structural view of the second control module 53 of the present embodiment, which differs from the first control module 53 in that the structure of the conductive sleeve conduction signal detection circuit 531 is different. [0103] As shown in FIG. 11 , the conductive sleeve conduction signal detection circuit 531 comprises a filter circuit 534 and a comparison circuit 236 . The filter circuit 534 is electrically connected to the second conductor 21 and is used for filtering the input signal; The comparison circuit 236 is electrically connected to an output terminal of the filter circuit 534 , the comparison circuit 236 comprises a comparator U 3 , a resistor R 10 and a resistor R 11 , a reverse input terminal of the comparator U 3 is electrically connected to a common terminal of the resistor R 10 and the resistor R 11 , the resistor R 10 and the resistor R 11 are used to provide a divided voltage as a voltage reference to the reverse input terminal of the comparator U 3 ; an output terminal of the comparator U 3 is electrically connected to a pin 3 of the microprocessor 532 , the other end of the resistor R 10 is electrically connected to the first conductor 51 and the positive electrode of the battery, the other end of the resistor R 11 is grounded, and a positive input terminal of the comparator U 3 receives a filtered conductive signal and compares the filtered conductive signal with a reference voltage signal of the reverse input terminal, and an output terminal of the comparator U 3 circuit outputs a comparison result signal as a trigger signal to the microprocessor 532 . [0104] FIGS. 7 and 8 show an electronic cigarette provided in the second embodiment of the present invention, the second embodiment differs from the first embodiment in that the structure of the atomization core 4 is different. [0105] As shown in FIG. 7 , the fixing block 43 is substantially a ring-shaped structure which is embedded and fixed to an inner side wall of the first base body 411 close to one end of the suction nozzle 2 . As shown in FIG. 8 , the fixing block 43 is a silicone member, an elastic piece (not labeled in figures) is defined on the fixing block 3 , the elastic piece has at least one elastic conductive arm 431 extending into the smoke passage of the atomization seat 41 , the vent pipe 32 is inserted in the smoke passage, and the elastic conductive arm 431 is resiliently abutted against and electrically connected to a sidewall of the vent pipe 32 . [0106] The present embodiment arranges the fixing block 43 and the elastic piece structure independently from each other, and is actually more reasonable in practice, and the elastic piece structure has a plurality of elastic conductive arms 431 , and by increasing the number of the elastic conductive arms 431 , stability of electrical connections between the elastic conductive arms 431 and the vent pipe 32 is increased to prevent a contact between the elastic conductive arms 431 and the vent pipe 32 from being poor. [0107] Further, one elastic conductive arm 431 is electrically connected to the atomization electrode assembly 46 , and as shown in FIG. 8 , the elastic conductive arm 431 is provided with a perforation 432 through which an electric wire (not labeled in figures) passes, one end of the electric wire is connected to the elastic conductive arm 431 and the other end of the electric wire is connected to the atomization electrode assembly 46 so that the elastic conductive arm 431 is electrically connected to the atomization electrode assembly 46 . Since the elastic conductive arm 431 is electrically connected to the vent pipe 32 and the suction nozzle 2 , then the atomization electrode assembly 46 is electrically connected to the vent pipe 32 and the suction nozzle 2 . It is to be understood that the above-described connection between the atomization assembly 1 and the battery assembly 2 is a detachably connection, and certainly, the structure of the battery assembly 2 and the atomization assembly 1 may be an in-detachable and integrated structure, namely, the electronic cigarette may be a disposable electronic cigarette, or other electronic cigarettes capable of repeatedly adding e-liquid to be repeatedly used, and the structure thereof is not particularly limited thereto. [0108] The present invention further provides an atomization control method of an electronic cigarette, the electronic cigarette is the above electronic cigarette, the atomization control method of an electronic cigarette comprises following steps: [0109] S1. conducting the first conductor 51 and the second conductor 21 by user's skin when the user contacts the first conductive sleeve and the second conductor 21 through the skin simultaneously, so as to generate a conduction signal to the control module 53 ; [0110] S2. controlling the power source to supply the electrical power to the heating wire assembly 42 to atomize e-liquid when the control module 53 receives the conduction signal and a smoking signal, the conduction signal is generated by that the first conductor 51 and the second conductor 21 are conducted. [0111] In general, the electronic cigarette and an atomization control method thereof of the present invention has following advantageous effects: [0112] (1) The first conductor is provided on the outer peripheral surface of the battery assembly, and the outer peripheral surface of the suction nozzle is provided with a second conductor, when smoking, the user directly holds on the first conductive sleeve by fingers, a mouth is held on the suction nozzle, so as to realize contacts between the conductive sleeves at different positions on the outer surface of the electronic cigarette and the user skin at the same time, and to transmit the conduction signal to the control module so that the control module controls the power source to supply the heating wire assembly to atomize the e-liquid and starts the electronic cigarette working. [0113] Therefore, the present invention can reduce a probability that the electronic cigarette is mistakenly triggered, effectively solves the problem in the prior art that the electronic cigarette works when the key switch, the touch switch or the airflow sensor is often mistakenly triggered, resulting in a change of deterioration of taste of the e-liquid of the electronic cigarette caused by repeated oxidization and, a short electronic cigarette life, low safety and other issues. Moreover, by providing the structure of the present invention, it is possible to reduce conditions of the packaging apparatus for transporting the electronic cigarette, thus to facilitate the transportation and the transportation is more secure. In addition, during a using process, the structure meets user requirements that the user can smoke when the fingers are held on the battery assembly and the mouth is held on the suction nozzle, it is more user-friendly, improves user experience, so as to avoid a complex using problem that the touch keys or switches are needed in the prior art, and to avoid the problem that the airflow sensor cannot detect the smoke signal when the smoking force is small, the e-liquid enters the battery assembly from the airflow channel, and other problems. [0114] (2) Since the atomization assembly is detachably connected to the battery assembly, it is convenient for the user to replace the atomization assembly after that the atomization assembly is damaged. [0115] While the embodiments of the present application are described with reference to the accompanying drawings above, the present application is not limited to the above-mentioned specific implementations. In fact, the above-mentioned specific implementations are intended to be exemplary not to be limiting. In the inspiration of the present application, those ordinary skills in the art can also make many modifications without breaking away from the subject of the present application and the protection scope of the claims. All these modifications belong to the protection of the present application.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] 62/010,116 FEDERALLY SPONSORED RESEARCH [0002] none SEQUENCE LISTING [0003] none BACKGROUND OF THE INVENTION [0004] With recent economic trends, people are increasingly being dislocated from traditional nuclear family living into the need for more flexible living arrangements. Not only are young family members leaving home for college, but also these same folks are often unable to find employment that avails them of their own homes as adults. The relative cost of home maintenance versus personal income is changing, and with it the need for low cost, easily transported and reconfigurable furniture. FIELD OF THE INVENTION [0005] Beyond this economic trend is an increasing number of transient endangered people fleeing away from unsafe economically, militarily or health threatened areas and into safer but more crowded regions where living quarters must be hastily created and protected against the spread of contagious disease. DESCRIPTION OF THE INVENTION [0006] My invention is an adaptable set of modules that can be arranged in several ways to provide a place to sleep, a table for eating, chairs of a simple Japanese zabuton style, or a set of shelves for the storage of items. This invention comprises four separate components—two types of base units, one type of cushion, and one type of shelf. As a kit, these could be purchased as a set of one central base unit, two end base units, three shelves and a handful of fasteners to hold them together in various configurations. Individual components such as clean cushions could be purchased separately as needed. [0007] Each base unit is fabricated, either as a single piece or as a structural equivalent pre-assembled from separate parts. Cost, simplicity and ease of cleaning are all major factors; therefore, this description will be arbitrarily exemplified by the case of single-piece molded parts. Each base unit is a flat panel provided on one of its two flat surfaces with several rectangular ribs. When placed on a floor horizontally and aligned end-to-end, with one central base unit situated between each of two end base units, this assemblage of three units forms the shape and size of a bed—for example 25 inches wide by 90 inches long—and provides a flat horizontal surface raised above the floor that can hold a trio of cushions that together form a mattress for sleeping. [0008] For more dedicated installations, a series of such adjacent beds can be lined up side-to-side to accommodate a large number of people, as in a homeless shelter. The trio of cushions could of course be economically replaced by single full-length mattress cushions instead. Raised above the floor level, as it is, this bed affords protection against insects, fluid spills and cold floor-level air. [0009] When used individually, each of the three base units with its associated cushion can serve as a kneeling pad or serve the function of a traditional Japanese zabuton chair used around a low eating table so that the diners may rest in a comfortable seiza kneeling position. [0010] Assembled differently, each of the two end base units may be arranged vertically on one edge, standing on the floor, spaced and supported across their top edges by the central base unit to form a shelf support. Each rib, aligned parallel to the floor, provides a ledge for supporting a shelf. Equipped with several shelves, the assemblage provides a storage unit or bookcase. [0011] Holes may be provided as appropriate to secure the various parts together and in position, using any set of conventional fasteners such as screws or removable pins or rivets. Likewise, surface fasteners such as hook-and-loop tape, straps or temporary adhesive can also serve to hold the cushions in position. Listing Of The Items Seen In The Illustrations [0012] 1 —Central Base Unit [0013] 2 —End Base Unit [0014] 3 —Shelf [0015] 4 —Cushion [0016] 5 —Fasteners [0017] 6 —Bed Assembly [0018] 7 —Rectangular Ribs [0019] 8 —Holes for Assembly [0020] 9 —Shelf Assembly [0021] 10 —Zabuton Chair Assembly EXPLANATION OF THE ILLUSTRATIONS [0022] FIG. 1 is an orthogonal view of the complete bed assembly showing the central base unit, flanked on either end by one each of the two end base units, and topped by the three cushions. [0023] FIG. 2 is an orthogonal view of the three base units assembled as in FIG. 1 , but inverted to reveal their bottom faces, showing their several rectangular ribs. [0024] FIG. 3 is an orthogonal view of the fully assembled shelf assembly. [0025] FIG. 4 is an orthogonal view of the shelf assembly, partially assembled. [0026] FIG. 5 is an orthogonal view of the central base unit arranged with one cushion to form a zabuton chair. Each of the two end base units can serve similarly. [0027] FIG. 6 is an orthogonal view of a typical cushion as would be used on the chair or the bed assembly. [0028] FIG. 7 is an orthogonal view of one exemplary shelf. [0029] It should be understood that these parts may be constructed in any of several ways. For example, additional features could be included in each of the several parts to permit additional combinations and permutations beyond those described here, or to strengthen the parts to serve more robust purposes. Unitary molded or extruded base units designed to avoid capillary action between separate parts afford simplicity, low cost and can be easily sterilized between occupants.

1a

FIELD OF THE INVENTION [0001] The invention relates to means of reducing wear in total joint replacements. Wear of Ultra High Molecular Weight Polyethylene (UHMWPE), still the most commonly used articulation material, is considered a major factor contributing to aseptic loosening and thus limiting the duration of artificial joints. Reduction of UHMWPE wear has been an important topic of research and development from the sixties with the increased urgency accorded to the problem in the last decade. Metal-metal combination produces less, but nevertheless, biologically, significant wear. Potential toxicity of metal ions is both, a major concern and a motivation to seek improvements. Here too, relatively even greater reduction of wear is possible by means of this invention. In the case of ceramic-ceramic articulations, the wear is very low, but the precision needed to produce them is extremely high and even minor deviations can lead to failures. This invention can mitigate the problem by reducing the wear principally and thus increasing the overall robustness of the joint and possibly relaxing the need for the exacting production technologies. BACKGROUND [0002] Four decades after its introduction into total joint replacement by Charnley, UHMWPE remains the most commonly used material for the concave part of the artificial joints, e.g. for the acetabular cup of the total hip prosthesis, or the tibial plateau of the total knee prosthesis. While it has played a central role in the success and widespread use of joint replacements, UHMWPE has also been identified as a major culprit in the most common mode of their failure—aseptic loosening. Wear particles produced by articulation of the hard, convex, usually metallic, or ceramic component against the soft polymer liner accumulate in and around the joint until the concentration of particles becomes so high that, in spite of the polymer's generally excellent biocompatibility when in bulk, they initiate a biological response leading ultimately to bone loss, loosening of the joint components and dysfunction of the joint replacement. [0003] Different methods of wear reduction have been sought, found and introduced into clinical use over the last few decades, all focused on improving the wear characteristics of the articulation pair at their interface. [0004] On the convex, metallic, or ceramic component these efforts included reducing roughness of the surface, increasing precision of the geometry, e.g. sphericity of the femoral head, and increasing hardness of the materials. Improved wetting of the hard surface has also been identified as an important factor in general wear reduction. [0005] These measures have been realized through: (i) better selection of and processing of metals, both in metallurgical aspects and in machining methods employed; (ii) use of hard coatings, added or created in situ, by e.g. oxidation; (iii) use of bulk ceramic components. [0009] The reduction of wear, both in laboratory testing and from in vivo observations is on the order of factor two. [0010] More recently, modifications of UHMWPE material through cross-linking have gained much attention. Cross-linking can be achieved by physical (irradiation) and/or chemical means. Laboratory testing has shown great variability, mostly due to different methods of wear production and assessment employed. Tests conducted on joint simulators and with careful compensation for artifacts, suggest factor five to ten reduction of wear vs. regular UHMWPE. [0011] A number of potential problems of cross-linking have been mentioned in, by now, vast literature on the subject. Among those is the reduction of strength, particularly in fatigue; reduction of average particle size, making the wear debris biologically more active; and risk of long term degradation in the body. [0012] Cross-linked UHMWPE is in broad clinical use for about five years—too short a time for the final judgement on its benefit-to-risk ratio. Several clinical observations suggest the actual wear reduction of about factor two, but again, there is much variability in methods used to assess the wear and thus in the reported results. [0013] Metal-metal articulations have been used before UHMWPE was introduced in the sixties, which has ever since dominated the clinical use. As the biological problems of UHMWPE wear surfaced in the eighties, metal-metal was re-introduced, with now better metallurgical and manufacturing technologies available and consequently promising the better clinical outcomes. The wear rates, compared to UHMWPE, are on the order of factor ten lower by weight; hundred times by volume. However, systemic accumulation of ions of potentially harmful metals has been observed, and the risks remain unknown, especially in younger patients, who are most in need of improved joint replacements. [0014] Ceramic-ceramic articulations are technically the best in terms of wear, but various regulatory obstacles and the high price have, until recently, kept their use to a small percentage of the total. There are also risks, if relatively low, of component breakage due to extreme brittleness of ceramics and rapid degradation of the articulation due to even minuscule imperfections of, or any damage to the surfaces. Sophisticated technologies and quality controls required in production have also been an impediment to their wider use. This invention offers a potential of wear reduction principally and consequently increased robustness of ceramic-ceramic articulations. A SHORT DESCRIPTION OF THE INVENTION [0015] Briefly, the invention improves the wear characteristics of the artificial joint through: [0000] (i) reduction/elimination of the contact (Hertzian) stresses; (ii) improved lubrication at the area of contact. [0016] Both of the effects result from the change in the geometry of the articulating surfaces. In the case of the total hip joint, the standard, state of the art, is the ball-and-socket geometry, e.g. a sphere in a sphere, placing the contact at a point, which due to elasticity of the components results in a more or less spread out, more or less circular area of the contact, with the peak stress in the middle. There are now broadly accepted manufacturing standards specifying sphericity, dimensions and surface finish of the articulations for total hip prostheses. [0017] Novel, optimal shapes of the articulating surfaces for total hip prosthesis according to this invention are either: (i) a spherical head in an aspherical cup, with a theoretical surface contact over a band centered at about 45 deg from the axis of revolution, or (ii) an aspherical head in a spherical cup, placing, again, the theoretical surface contact over a band centered at about 45 deg. [0020] In both cases the aspherical component is a body of revolution, leaving a gap between the articulating surfaces at the area where in the conventionally shaped components the stresses would be the highest. The axes of revolution in both cases should approximate the axes of major in vivo loading in order to maximize the benefit. This makes the production and surgical application somewhat more complicated, but is well justified in view of the need to extract the maximum benefits. [0021] For a spherical articulation, such as used in total hip prostheses, the theoretical point-contact stress changes into a theoretical surface stress, principally eliminating the Herzian stress, leading to a substantial reduction of the peak stress. Just how much that is, depends on the moduli of elasticity of the two components and the difference in the radii of curvature in the conventional articulation, as well as the width of the band of the surface contact in this novel articulation. In general, the harder the materials used, and the bigger the difference in the radii of the conventional pairs, the bigger the potential improvement. However, in all cases, even with the soft polymeric cup, a highly significant and relevant improvement is possible. [0022] Improved lubrication is perhaps just as important for wear reduction. It is effected by the fluid entrapped between the articulating surfaces in the gap created by the above mentioned geometrical combinations. This fluid is pressurized by the elastic deformation of the components and exuded through the inter-articular gap at the surface contact. In conventionally shaped components the fluid is rapidly lost from the pole (point of contact) leaving the contact area dry. This especially so in the conditions of semi-static load, e.g. at the heal-strike of the gait, where the loads are high and the speed is low. The resulting mode of lubrication is commonly termed “mixed mode”, changing between elastohydrodynamic and boundary mode. [0023] In a gross approximation, the lubrication mechanism of the joint according to this invention resembles “weeping” lubrication of the natural, cartilage covered joint. Under increasing load, as the pool of fluid in the gap is pressurized, fluid is pushed out through the sealing gap between the components; when the load is reduced, and thus the sealing efficiency at the area of contact, the elastic recoil of the components will create an underpressure in the gap and suck the fluid back in. This aspect of wear reduction by the disclosed changes in geometry plays a bigger role in the softer materials, because elastic deformation leading to fluid pressurization is essential for the mechanism to function as described. [0024] Yet another benefit of the invention is the increased stability of the kinematic pair. A ball in an oversized spherical cup can freely rotate about all three axes, but it can also experience a wobble about the pole (point of contact), perhaps a micro wobble, but nevertheless a wobble. This can result in cavitation with all of the surface damage sequelae and ultimately an increased wear rate. Moving the contact away from the pole out to a surface of contact centered at about 45 degrees from the polar axis provides a stable seat for the ball (head of the joint) even as the load moves within its physiological window. [0025] The invention has been reduced to practice as a metal-backed UHMWPE cup liner, shaped as an aspherical body of revolution, and tested for wear up to 5 million cycles against a spherical metal head. The wear was reduced by approximately factor seven to fifteen, in comparison to published results obtained for conventional UHMWPE-metal combinations in the identical or similar test protocols. This matches the results obtained by cross-linking UHMWPE. [0026] Finite Element Method stress analysis has been performed on different combinations of the metal-backed UHMWPE liner of standard spherical shape and of the novel shape, demonstrating over 50% reduction in the peak Von Mises stress in the UHMWPE cup liner. [0027] Predicted theoretical reductions of contact stresses in metal-metal, or ceramic-ceramic joints are even higher, but the role which lubrication may play is difficult to calculate and there is as yet no experimental verification. [0028] Straightforward generalizations to other, more complex, less conforming shapes, e.g. a knee joint, are expected to result in lesser, but still significant reductions of wear. PRIOR ART [0029] CH449173, “Gelenkprothese”, by Maurice Mueller, discloses a metal on metal prosthesis, whereby the contact is limited to polymeric pads seated into their recesses within the cup. [0030] DE4423020, “Gelenkprothese”, by Wolfgang Fitz, discloses a hip prosthesis cup with a reservoir for the lubricating fluid in the unloaded, inferior region, combined with grooves, known in general art of sliding bearings as advantageous, because wear particles are more readily removed from the articulation. [0031] DE19604458, “Gelenkpfanne”, by Hagen Seifert, discloses a cup of the hip prosthesis shaped so as to make exclusively a ring contact to the head near the equator, leaving a spherically shaped recess in the cup filled with fluid and thus, enabled by grooves in the contact area, acting as a shock absorber. Controlling the stiffness of the cup, there are a number of ring shaped cavities within the cup wall. The concept is essentially one of a hydrodynamic bearing. Devoid of fluid support (as would happen in any case if the loading persisted long enough, e.g. fractions of a second) it would either result in very high friction torque, if the load were to be supported by the near-equator contact zone, or it would be reduced to a standard bearing (plus the friction at the contact zone) if the head fell into the recess. [0032] DE19915814, “Gelenk-Endoprothese mit verschleissarmer Gleitpaarung”, by Manek Buttermilch, et al., discloses a ceramic-ceramic total hip prosthesis, whereby the contact between the two articulating components is a line contact, made to be that by either a modified head geometry or modified cup geometry. In both cases the mismatch is produced by replacing a single radius of curvature by two, with offset centers, resulting in a line contact. Herzian stresses are reduced, but not eliminated. Geometry of this invention is also characterized by the fact that the aspherical component of the articulation presents a kink (the two circles defining the cross-section of the aspherical component are not tangent) in its contour at the line of contact. [0033] EP0053794, “Cup for a hip joint”, by Manfred Semlitsch, et al., discloses an endoprosthesis, in which both the joint ball and the hip joint cup consist of oxide ceramic material, an annular recess is arranged in the area of the opening of the hip joint cup, in which recess a ring of bioinert, plastically deformable material is situated. The surface of the ring facing towards the joint ball merges essentially without interruption and entirely steplessly into the spherical surface of the cup. In the event of subluxation and an associated short-term, linear-type bearing contact between joint ball and joint cup in the edge area of the cup, the result, even in the case of dry friction, is a favourable tribology between the joint ball and the ring of plastically deformable material which comes into engagement with the ball upon subluxation. [0034] EP0821922, “Hip prosthesis joint component with particulate trap”, by Claude Hubin and Marie Jean Sterpin, discloses a hip prosthesis cup for metal-metal articulation provided with a polar recess which serves as a trap for wear particles. Alternatively, the head can also have a trap/recess. [0035] FR2727856, “Ensemble prothetique auto-lubrifiant pour l'articulation de la hanche”, by Barba Laurent et al., discloses a hard-hard (metal-metal, or ceramic-ceramic) articulation for a total hip prosthesis of such shape and dimensions that a laminar film of synovial fluid can be maintained in use. A reservoir for the fluid is provided at the polar region. No details are provided as to what the geometry of the cup should be to meet the requirement of fluid film lubrication, other than the gap between the cup and the head being in the range of 0.005 and 0.05 mm, which covers the standard radial clearance used in hard-hard bearings. [0036] GB1322680, “Improvement in and related to prosthesis”, by Georges Girard and Ramiro Cameo, discloses a total hip prosthesis, whereby the surface of the head is provided by a pattern of grooves intended to reduce the wear at the articulation. As a prior art, the inventors cite a prosthesis whereby the spherical head is articulating against a cup of “football shape”, i.e. elongated, which leads to a line contact, rather than a point contact. [0037] US2002/0116068, “Containment system for constraining a prosthetic component”, by Terry McLean, describes a truncated head of the total hip prosthesis which can be inserted into the cup sideways through the slots in the opening of the cup before turning into the functional position. This results in the head being retained within the cup which covers more than 180 degrees. The unintended result is that the conventional point contact is now changed into a line contact along the edge of the truncated segment of the head. [0038] US2005/0246026, “Modular orthopaedic implant apparatus”, by Paul Lewis, et al., discloses a modular acetabular cup comprising three elements, which can be combined in different ways to allow the surgeon the choice of implants of varying sizes and features. Fixation is through a central bore of all three, thus, like in U.S. Pat. No. 6,527,809, changing the point contact into line contact along the edge of the liner. [0039] US2005/0261776, “Prosthetic joint with annular contact bearing surface”, by Scott Taylor, discloses a truncated, or annular, acetabular component of a total hip prosthesis, whereby the contact of the head and the inner of the two members of the cup occurs along a line instead of at a point. [0040] U.S. Pat. No. 5,181,926, “Bone implant having relatively slidable members”, by Rudolf Koch and Robert Streicher, describes a total hip prosthesis, whereby the cup side, within cavities in its polymeric liner, contains self-aligning pads of hard material which articulate against the head. [0041] U.S. Pat. No. 5,549,693, “Cotyloidal prosthesis”, by Christiane Roux and Michel Pequignot, discloses a total joint prosthesis, whereby the cup side contains at its opening a ceramic ring, much like a natural labrum, which forms a seal to the ceramic head. Position of the ring is such that the frictional moment of the couple would be very high. [0042] U.S. Pat. No. 5,593,445, “Bi-axial prosthetic joint”, by Thomas Waits, describes a total joint prosthesis whereby a third, ring-shaped, member is interposed between the head and the cup, increasing the contact area under load, self aligning between the head and the cup in the direction of the load. [0043] U.S. Pat. No. 5,702,456, “Implant having reduced generation of wear particulates”, by David Pienkowski, discloses a method of pre-wearing the prosthesis before implantation, whereby the usually somewhat increased amounts of particles produced by wear-in process do not burden the body. Only a minimal improvement for the long term outcomes could be expected from such a procedure. [0044] U.S. Pat. No. 5,725,593, “Total anatomic hip prosthesis”, by Francesco Caracciolo, discloses a resurfacing total hip prosthesis, whereby the femoral cup has multiple circular rises, intended to reduce the friction within the spherical cup. [0045] U.S. Pat. No. 5,766,258, “Wrist prosthesis”, by Beat Simmen, discloses a wrist prosthesis, whereby in one of the embodiments of the invention one of the two separate articulations is produced with non-circular members so that they tend to fall, or self-center, into a stable position, in which they become congruent. [0046] U.S. Pat. No. 6,527,809, “Trial acetabulum or implantable acetabulum with adjustable orientation”, by Levon Doursounian and Michel Porte, discloses a modular acetabular cup, whereby the cup inlay which articulates against the head has a central opening allowing access to the mechanism of locking the cup in the desired position. This, as a side effect, defines the contact conditions between the head and the inlay as a line contact along the edge of the central opening, as is the case in U.S. Pat. No. 4,840,631, “Artificial hip joint socket with hydraulic head support”, by Robert Mathys, but without the hydraulic pressure support disclosed by Mathys. [0047] U.S. Pat. No. 4,031,570, “Prosthetic acetabulum”, by Otto Frey, discloses a torus-shaped aspherical cup with the radius of the curvature equal to that of the spherical head, but with the center of the curvature offset from the central axis so as to avoid jamming of the head in the cup, changing the theoretical point contact of a sphere in a spherical socket into a line contact of a sphere in a toroidal socket, and further, for the purpose of improved lubrication, a groove at the periphery of the cup and a recess/pocket at the pole. Herzian stresses are reduced by changing from the point to line contact, but not eliminated as by the current invention which changes point to surface contact. [0048] U.S. Pat. No. 4,840,631, “Artificial hip joint socket with hydraulic head support”, by Robert Mathys, discloses a hip joint articulation with a cylindrical recess machined into the cup so as to create a reservoir for the joint fluid, which would pressurize under the load, sealing provided by the edge of the recess. The disantvantage of this solution is in the high stresses produced at the edge of the recess, which could lead to localized wear, potentially to loss of the seal and hence of hydraulic support. [0049] U.S. Pat. No. 5,336,267, U.S. Pat. No. 5,383,936, U.S. Pat. No. 5,738,686 and U.S. Pat. No. 6,312,471 by Dietmar Kubein-Meesenburg et al. disclose theoretical basis and solutions to reducing stresses in articulations of joint prosthesis, all of which lead to theoretical line contact instead of point contact. Herzian stresses are reduced, but not eliminated. [0050] GB 1322680, “Prosthesis”, by Georges Girard et al. discloses a metal-metal total hip joint articulation, whereby the concave, cup, component is provided with multiple groves leaving only protrusions ending on a spherical surface to contact the spherical head. This type of contact is proposed to reduce the risk of jamming of conventional, smooth, spherical surfaces of a ball-in-socket joint, specifically in metal-metal combination, where the required tolerances are tight and difficult to maintain in production. [0051] U.S. Pat. No. 6,645,251, “Surfaces and processes for wear reducing in orthopaedic implants”, by Abraham Salehi et al. discloses an approach based on grooving the concave surface in order to improve lubrication and distribute the stress. As known from technical sliding bearings, the main advantage of grooves comes from improved removal of wear particles away from the articulation. Fluid entrapment may play a role in improved lubrication as well. However, grooves as disclosed may in fact lead to higher local stresses at the edges of the grooves and defeat the purpose. There has been no published data supporting the concept and no evidence of even limited acceptance of this approach by the orthopaedic device industry. [0052] U.S. Pat. No. 6,425,921, “Sliding partners for artificial joint implants”, by Hans Grundei and Wolfram Thomas, discloses an alternative approach where the grooves are produced in the convex component of the joint. Actual hip simulator tests performed on this type of joint components did not show any wear reduction. [0053] None of the cited documents, nor any combination of them, teaches those skilled in art how to design an articulation for an artificial joint which principally eliminates Herzian stresses at the contact and still allows for movements with low frictional torque. [0054] Practical limitations on accuracy of the machinable components, including effects of temperature and of radiation-induced shrinkage, if used for sterilizing polymeric cups, and the safety against jamming of the components when used in the body, have led to international standards which guarantee acceptable in vivo performance. [0055] ISO standards 7206-2; 27.80 to 28.00 and 7206-2; 28.10 to 28.30 specify the geometry and dimensions of the head and cup components, respectively, of a total hip prosthesis. [0056] Sphericity and dimensional tolerance of the head component—The metal or ceramic femoral head component of a total hip prosthesis shall have a departure from roundness of not greater than 10 micrometers. If used against hard material cups (metallic or ceramic) it will not be greater than 5 micrometers. The diameter shall be equal to nominal diameter +0.0, −0.2 mm. For metal-metal or ceramic-ceramic articulations the tolerances are not specified, but in all cases there shall be radial clearance. In practice, the heads are today produced with significantly tighter specifications than required by the standards. [0057] Sphericity and dimensional tolerance of the cup component—For polymeric component the sphericity is not specified; for hard materials it shall not exceed 5 micrometers. The dimensional tolerance for polymeric cup is +0.3, +0.1 mm at 20±2 deg C. from the nominal diameter. In practice, UHMWPE cups are oversized by at least +0.2 mm over the nominal diameter. No tolerance for the metallic or ceramic cups are given, but the radial clearance must be guaranteed by the producer. Typical radial clearance for hard pairs is in the range of 0.02 to 0.030 mm. DETAILED DESCRIPTION List of Figures [0058] 1. A schematic cross sectional view of the artificial hip joint articulation according to current standards. [0059] 2. A schematic cross sectional view of the artificial total hip joint articulation according to the invention, showing a spherical head in an aspherical, fossa cup. [0060] 3. A schematic cross sectional view of the artificial total hip joint articulation according to the invention, showing an aspherical, fovea head in a spherical cup. [0061] 4. A cross sectional view of the artificial total hip joint according to the invention, showing a spherical head in an aspherical, fossa cup, whereby the axis of symmetry of the cup inner shape is offset from the main axis of the cup, so as to place the fossa of the cup into the window of major joint force vectors acting on the cup in actual use. [0062] 5. A cross sectional view of the artificial total hip joint according to the invention, showing an aspherical, fovea head in a spherical cup, whereby the axis of symmetry of the head outer shape is offset from the main axis of the head, so as to place the fovea of the head into the window of major joint force vectors acting on the head in actual use. [0063] 6. A perspective view of a total hip articulation showing contact area under load. [0064] 7. A perspective view of the tibial plateau of a partial, or a total knee prosthesis showing a fossa feature. [0065] 8. A cross sectional view of a spinal disk prosthesis according to the invention. [0066] For a simple and clear presentation, a total hip joint articulation has been chosen for this disclosure, but the same technical arguments and design approaches can be used for articulations of other joint prostheses, which, generally, have less conforming surfaces and lesser degree of coverage. [0067] FIG. 1 shows a conventional, standardized total hip prosthesis articulation, with a spherical convex component, or head, 2 , seated into a spherical concave component, or cup, 1 . The theoretical contact between them is at a point 9 , provided that the load is oriented along axis 10 . The articulating surface 3 , of the cup 1 is of spherical shape with a radius 4 , centered at point 5 . The surface 6 , of the head 2 , is also spherical, of radius 7 centered at point 8 . The shapes of the two components are axisymmetric, i.e. both are bodies of revolution and can be described in a polar coordinate system, with the origin 8 , the polar axis 10 and the polar angle 12 . The gap width 11 is zero at the polar angle 12 of zero degrees, i.e. at the pole; it approaches maximum radial clearance equal to the difference between the radii 4 and 7 at the polar angle of 90 degrees. Distance 13 between the points 5 and 8 is equal to the difference between the radii 4 and 7 , i.e. 13 is the radial clearance. For UHMWPE cup liners and metal or ceramic heads the usual radial clearance is in excess of 0.1 mm; for metal-metal pairing it is usually less than 0.03 mm. [0068] Diameter 15 of the cup opening is larger than the diameter 14 of the head 2 , so that the head 2 can freely come into its seat within the cup and make the contact at point 9 . Under load the point contact will spread out into a surface contact, resulting stresses being known as Herzian, after Heinrich Hertz, who with his 1882 classic publication has provided theoretical basis for calculating contact stresses between bodies of simple geometrical forms (Hertz, H.:“Gesammelte Werke”, vol. I, Leipzig, 1895). Formulas to calculate Herzian stresses are given in e.g. “Formulas for Stress and Strain”, Fifth Edition, Roark and Young, McGraw-Hill, 1982, Chapter 13. The subject is extensively covered in e.g. “Contact mechanics”, K. L. Johnson, Cambridge University press, 1985. For a sphere in a spherical socket the formulas are valid only if the radius of the socket is larger that that of the sphere; improved formulas for closely matching radii have also been developed, but if the radii are equal, the contact stress in the Herzian sense is eliminated. [0069] FIG. 2 shows the head 102 in the cup 101 articulation according to this invention. The head 102 is spherical with its surface 106 having a radius of curvature 107 with the center at the point 108 . The articulating surface 103 of the cup 101 is aspherical—more precisely—only partially spherical, axisymmetric around the axis 110 . Over an arc 120 , between the polar angles 113 and 114 , the surface 103 is spherical, congruent to the head surface 106 . In 3D the arc 120 defines a band 121 of theoretical contact, a section of a spherical surface, FIG. 2 a. [0070] For polar angles larger than 114 the radius of curvature 104 , of the surface 103 , with the center at 105 , is larger than the radius 107 , opening a gap between the two articulating surfaces 103 and 106 . [0071] For polar angles just smaller than 113 , the radius of curvature of the surface 103 is also larger than of the surface 106 , again opening a gap 111 . As the polar angle approaches zero, the radius of curvature of the surface 106 , is decreased to round off the shape of the cup at the pole 109 . The resulting gap at the pole is 118 . [0072] The arc of circle 120 of perfect congruency is centered at the polar angle 115 , and its corresponding width angle is 116 . [0073] The position, 115 , and the width, 116 , of the band of theoretical surface contact are subject to parametric optimization. First order approximation suggests that the angle 115 should be about 45 degrees; the width 116 about 30 degrees. Theoretical optimizations, coupled with experimental testing, including a cost-function placed on the frictional moments of the articulation, are expected to place the angle 115 into the range between 20 and 50 degrees; the surface contact width 116 into the range between 10 and 40 degrees. [0074] The band of contact 121 , shown in a perspective view on FIG. 2 a , defined by the arc 120 , encloses a volume 130 at the polar aspect between the surfaces 106 and 103 of the head and the cup, respectively. [0075] Opening 140 of the cup is larger than the diameter of the head 141 , resulting in the clearance 117 , so that the head is free to seat itself into the cup generating a surface contact along the area 121 . [0076] The type of cups shown on FIG. 2 will be referred to as fossa type. Fossa in general means a cavity, or depression, and in case of the hip acetabulum, it is a centrally located recessed area not covered by cartilage. [0077] The scale of the fossa gap is greatly exaggerated on this and on the following figures. In reality, it will depend on the materials used. For an UHMWPE cup of the fossa type the maximum gap size, which conveniently would be 118 at the pole 109 , should be big enough, so as to avoid bottoming out of the head 102 even after maximum anticipated use of the prosthesis, e.g. for 50 years. The wear tests conducted until now suggest the rate of about 4 micrometers per million cycles of loading, which may correspond to 1 to 2 years of in vivo use. To allow for 50 years of wear without bottoming out, the gap 118 should be 0.2 to 1 mm; 2 mm would give a safe margin, but this may call for fairly significant changes of the radius vector 104 for the polar angles between the axis 110 and the first angle of contact 113 . [0078] Ideally, the changes of the radius of curvature of the surface 103 below and above the angles 113 and 114 , respectively, should be continuous, but for practical reasons one or two steps will suffice, especially if machined in the soft polymeric materials like UHMWPE. It is highly preferable, though, that the transitions are tangential, i.e. that the contour of 103 is smooth, as shown in FIG. 2 b . Radius r 1 of the arc 120 centered at C 1 is the nominal radius, equal to that of the head. Radius r 2 , corresponding to the arc 122 , is centered at C 2 and is larger than r 1 . As shown, the centers C 1 and C 2 should be placed on the radi-vector defining the transition from 120 to 122 , so as to make the transition smooth, i.e. there is a common tangent to the arcs 120 and 122 at the transition point. Radius r 3 with the center C 3 defines the arc 124 ; r 4 with the center at C 4 the arc 123 ; radius r 5 , with the center at C 5 the arc 125 . [0079] For metal-metal and ceramic-ceramic articulations the gap 118 should be about 5 to 10 times smaller than for UHMWPE; i.e. in the range from 50 to 200 micrometers. [0080] To minimize the production of wear, international standards (ISO, ASTM) have proposed the upper limits on the roughness of the articulating surfaces: (i) UHMWPE cup maximum Ra of 2 micrometers (approximately grade N7); today, UHMWPE cups are typically machined to surface roughness of N5 to N6, corresponding to Ra of 0.4 to 0.8 micrometers; (ii) metal or ceramic heads maximum Ra of 0.05 micrometers (grade N2); ceramic heads are typically finished with Ra of less than 0.01 micrometers. [0081] Notwithstanding the value of the standards, in light of the importance of maximizing the efficiency of dynamic lubrication, the surface finish of the inner surface of the cup, and particularly of the UHMWPE cup, should not be uniform over the entire surface. The unloaded, theoretical surface contact over the arc 120 , FIG. 2 b , under load will spread out to a wider band towards the pole 109 by a partial width of the arc 123 and towards the equator by a partial width of the arc 122 . This broader band of contact represents the envelope for major loading vectors across the joint, not only a static, single position/load. All of this surface should be machined to a high degree of smoothness, e.g. N5. The rest of the cup surface, in order to maximize dynamic resistance to fluid flow out from the pressurized pool 130 , should have a higher degree of roughness, preferably at about grade N12, corresponding to Ra of 50 micrometers. As suggested on FIG. 2 b , the preferred texture is that of grooves running at 90 deg to the direction of flow, which naturally would be the result of machining the cup by turning its inner surface, as is most commonly done. [0082] FIG. 3 shows an alternative way of providing similar articulating conditions: the cup 201 is now spherical and the head 202 is aspherical, congruent with the cup along the arc 220 of the surface contact 221 , leaving again a volume 230 enclosed by the surfaces 203 and 206 of the cup and the head, respectively. The radius of curvature 207 of the head 202 for polar angles greater than the angle 213 and lesser than the angle 214 is equal to the radius of curvature 204 of the cup's inner surface 203 . For polar angles lesser than 213 , the radius of curvature of the head surface first is smaller than 204 to open up a gap 211 . Closer to the pole 209 , the radius of curvature is larger to avoid indenting the surface of the head at its polar region. For polar angles larger than 214 the radius of curvature of the head surface is also lesser than 207 , to avoid jamming the head in the cup at equatorial region. The diameter of the head 241 at its equator is smaller than the diameter 240 of the opening of the cup. [0083] This type of heads will be referred to as fovea type. Fovea also means a pit or cuplike depression and is used to describe the recessed or flattened area of the femoral head where the round ligament inserts. [0084] Ideally, the changes of the radius of curvature of the surface 206 below and above the angles 213 and 214 , respectively, should be continuous, but for practical reasons one or two steps will suffice. It is highly preferable, necessary in fact, that the transitions are tangential, i.e. that the contour of 206 is smooth. [0085] Which one of the two solutions is more appropriate depends on the materials and manufacturing technologies employed. For example, if UHMWPE is used for the cup with either a metal or a ceramic head, making the cup aspherical is much easier than making the heads aspherical. This especially so if the cup is compression molded. [0086] For metal-metal, and probably for ceramic-ceramic combinations it may well be easier to produce a fovea head than a fossa cup. [0087] To get the maximum benefit of either geometry, the axis 110 , respectively 210 , should be directed into the window of functional, physiological force vectors acting on the articulation. [0088] FIG. 4 is a schematic representation of the total hip prosthesis, with the cup 101 inserted into pelvic bone 501 , and the head 102 affixed to the femoral stem 502 , which in turn is inserted into the femur 503 . The axis of the femoral neck is 504 . The axis 110 of the fossa geometry of the cup 101 is offset from the main axis 509 of the cup, by an angle 510 . If the angle 510 is approx. 25 degrees, and the cup is inserted at an angle of lateral opening 511 of approx. 45 deg, the arc of contact 120 (corresponding to the band of contact 121 , FIG. 2 a ) centered on the axis 110 , will meet the requirement to encompass most of the physiological load vectors 512 transmitted from the head to the cup. The cup should also be inserted with an angle of so-called anteversion (pointing forward) of about 10 to 15 degrees. Such a cup must be clearly labeled for the surgeon to be able to orient it properly at insertion. [0089] FIG. 5 shows the preferred position of the fovea depression on the total prosthesis head 202 with respect to the femoral neck, of the femoral stem 502 , as indicated by the angle 510 between the axis 210 of the fovea and the neck axis 504 . The angle 510 should again be approx. 25 degrees. If modular design is used, there must also be a clear indication for the surgeon on which aspect of the head is to be placed superiorly. [0090] FIG. 6 shows a perspective view of the contact area 121 , respectively 221 , of the articulation of either fossa or fovea type under loading. Due to elasticity of the components, the area of contact will spread out from the original annular surface contact, FIG. 6 a , to a wider area of surface contact FIG. 6 b . The width 53 of the contact area 121 ( 221 ) is load dependent. When the load is high, the fluid from the pool 130 is pushed out, as shown by arrow 51 , through the gap over the area 121 ( 221 ), across, now, the longer distance 53 , FIG. 5 b . As the load is reduced, the elastic recoil of the components will tend to increase the volume of the pool 130 and thus suck the fluid back in, as shown by the arrow 52 , FIG. 5 a . In this phase, the contact area is narrowed down, i.e. 53 is reduced, and thus there is less resistance for the re-filling of the pool 130 . This is important, since the maximum underpressure which can pull the fluid back in is 1 bar, while much higher pressures can be induced during the draining, high load, phase. [0091] In case of UHMWPE cup, this non-linearity can be enhanced by provision of a gentle undulation in the shape of the cup over the contact area, i.e. by providing an interrupted area contact 54 , FIG. 6 c . Under loading, the gaps in the surface contact will close, increasing the resistance to flow out; as the load is reduced the gaps will open allowing for reimbibing of the fluid into the pool 130 . If UHMWPE is used for one of the components, articulations as those described above, can demonstrate relevant time dependent behavior; i.e. deformation of the solid components can only be calculated precisely by solving for the fluid flow as well. While more demanding from the engineering point of view, taking all of these factors into consideration may ultimately reduce the level of wear to an absolutely negligible level. [0092] FIG. 7 shows saggital and frontal sectional views of a knee condyle prosthesis with the femoral component 402 making a surface contact 420 against the tibial plateau 401 , produced from UHMWPE, of the fossa type. The area of the tibial component 401 , which normally would be exposed to highest stresses, is now slightly recessed defining the pool 430 , providing for the above-explained means of load distribution and dynamic lubrication. The femoral component being shaped as a torus, the two sectional views differ only in the respective curvatures of the articulating components. [0093] FIG. 8 shows a spinal disk prosthesis according to the invention. The central, lens-shaped body 302 , made from either UHMWPE, or a hard material such as ceramic, or metal, articulates on both of its faces against concave components 300 and 301 , along surfaces 320 , so as to leave gap volumes 310 filled with fluid, providing again for the above-explained means of load distribution and dynamic lubrication. [0094] There are many ways to approach the practical problem of designing more or less optimized shapes of different articulations. Simple analysis, based on known formulas for Herzian stresses, can be used to guide the design aiming to minimize the contact stresses. For a ball-and-socket joint, assuming no friction at the gliding surfaces, the result is straightforward, suggesting the optimum solution with the contact area centered at 45 degrees. Introducing friction, shifts the optimum angle downwards. And since the invention changes the mode of lubrication, hence the coefficient of friction, the problem of exactly solving for an optimum quickly becomes much more complex. Finite element method can be used to solve for solid stresses, and the optimum design can be sought by either parametric approach, or by min-max methods. Ultimately, fluid flow analysis could be incorporated into these models as well. To minimize the wear in the actual use, however, another, very serious escalation of complexity would have to be brought in—the mechanism of wear and the presumed regimen of use. [0095] An alternative approach would be to start with analysis of the existing articulations, and then, by iteration, remove some material from a chosen side of the articulation, at the areas of maximum stress, aiming to minimize the peaks. For reduction of wear, a cost function should be created penalizing the locations prone to produce more wear in presumed physiological use, i.e. those which experience high relative motion when under load. [0096] The inventor has taken a pragmatic approach of using the ready formulas for Herzian stress to guide design of the UHMWPE cup for a total hip prosthesis and then performing the actual wear testing in hip simulators against a standard metal head to verify the reduction of wear. There are now internationally accepted standards for wear testing (ISO 14242-1:2002-03), which allow for relatively safe comparisons between different laboratories and different test runs. Whatever the design process, experimental results are ultimately needed to prove the value of inventions in this area. The UHMWPE cup tested was exposed to conventional gamma sterilization, yet the wear rate (3.5 mg/mio cycles) against a 28 mm metal head was at the level of that of highly cross-linked UHMWPE (4 mg/mio cycles). The wear of standard UHMWPE cups has been measured under similar conditions in the range of 35 to 50 mg/mio cycles. [0097] This superior outcome of the testing is due to probably all three important aspects of the invention: reduction of stresses in UHMWPE; improved dynamic lubrication at the contact areas; and improved stability of the joint under varying load vectors. Dispersion of the wear rates was also extremely low compared to conventional designs, suggesting reduced risk in clinical use due to unavoidable specimen variability. [0098] Regarding terminology used in the disclosure, the crucial concept is that of congruency of the articulating pair over a defined area of contact. The theoretical concept of congruency is simple and unambiguous, but in practice it is a subject to practical limitations of achieving it. The production tolerances set a limitation on what can be achieved in terms of matching the shapes of the two components. As the production methods and the tolerances change rather rapidly, setting the limits of what congruency means for the years of the patent life is not possible. Therefore, when the term congruency is used, and unambiguously related to what is meant by equal radii, it defines the intent and the outcome of the intent as materialized in the product, produced by the state of the art technology. The intent to produce congruent components routinely covers the anticipated changes of the dimensions and the shapes due to complete production and ultimate conditions of use, such as influence of sterilization (e.g., gamma sterilization results in the shrinkage of UHMWPE) mounting of the components (e.g. use of press fit into a metal backing) and temperature during use in the body. Those skilled in art at any particular time period and technology level know what meaning to attach to congruent surfaces—this knowledge is implied in the use of the term in this text. [0099] When faced with a possible issue of infringement one could envision a functional test whereby the two components would be brought into articulation and loaded with a tare-load to estimate the extent of contact. Tare-load, however, is not of a fixed value, but rater a function of the particular joint in question and would be determined for the particular articulation by using a conventional design as a control. For example, a conventionally designed metal-UHMWPE pair under a load of 100 N (approx. 5% of average peak load in walking) would show a circular contact area at the pole, whereas the pair designed to the specifications presented in this disclosure would show a ring of contact centered at approx. 45 degrees and about 30 deg wide.

1a

FIELD OF THE INVENTION [0001] The invention relates to a personal care cream composition. The invention more particularly relates to a photo-protective personal care composition that maintains its sensory properties while ensuring high sun-protection efficacy. BACKGROUND OF THE INVENTION [0002] Solar radiation includes about 5% ultraviolet (UV) radiation, wavelength of which is between 200 nm and 400 nm. It is further classified into three regions: from 320 to 400 nm (UV-A), 290 to 320 nm (UV-B) and from 200 to 290 nm (UV-C). A large part of UV-C radiation is absorbed by the ozone layer. Scientific studies have indicated that exposure to UV-A and UV-B radiation for short period causes reddening of the skin and localized irritation, whereas continued and prolonged exposure can lead to sunburn, melanoma and formation of wrinkles. It is also reported that UV radiation causes significant damage to hair. Therefore, it is desirable to protect the skin and other keratinous substrates of the human body from the harmful effects of both, UV-A and UV-B radiation. [0003] Various cosmetic preparations have been reported for preventing and/or protecting the skin from harmful effects of ultraviolet radiation. Numerous organic sunscreen agents capable of absorbing UV-A rays are reported in the field of cosmetics. Many UV-B sunscreens are also known and approved for safe use in personal care compositions for protection from UV-B radiation. [0004] Inorganic sunscreens, also known as inorganic sun-blocks, are also used in photoprotective compositions. They work by blocking out the rays of the sun, no matter what the wavelength. They are included in such compositions in carefully calculated amounts and in carefully determined particles sizes. This is necessary since a choice of the wrong particle size or amount leads to either poor sensories on application of the composition on the skin or an unnatural whitish appearance when applied on the skin. Commonly used inorganic particles are zinc oxide, iron oxide, silica, mica, titanium dioxide or coloured pigment particles. [0005] Cosmetic compositions are formulated in various cosmetically acceptable vehicles (or bases) depending on the sensory properties desired. Compositions may be formulated in an anhydrous vehicle or a water containing vehicle. Compositions comprising water may be formulated as a gel or as an emulsion. Gels are generally compositions comprising predominantly water with minimal or no oily phase. Composition comprising both water and oily phase are formulated as emulsions which may be an oil-in-water emulsion or a water-in-oil emulsion. The difference between these two types of emulsion is that although the ranges of water and oil overlap, the difference is in whether water is the dispersed phase or the continuous phase and vice-versa. The present invention relates to a water containing composition in the form of a oil-in-water emulsion which comprises fatty acid or an ester thereof and a cross-linked acrylic acid polymer. This type of a composition gives an emulsion in a lamellar phase. When such compositions are rubbed on to the skin they give a watery sensation which are liked by many consumers. When such compositions are to be formulated for sunscreen benefits, by including inorganic particles in them, they tend to cause an inordinate increase in the viscosity of the compositions. Concomitantly they affect the tactile sensory appeal of the compositions when they are rubbed on to skin. It is thus a problem to incorporate even small amounts of inorganic particles in such compositions without affecting the sensory appeal. The present inventors have, through extensive experimentation determined that inclusion of hydrophobic polymer particles of a specified particle size range enables such compositions to not only provide the sunscreen benefits but also deliver the excellent watery sensation the consumers have come to expect from such compositions. [0006] US2008242573 (Procter & Gamble) relates to a multiphase personal care composition which comprises an aqueous structured surfactant phase, a structuring system, and a benefit phase. The aqueous structured surfactant phase comprises from about 5 percent to about 16 percent, by weight of the multiphase personal care composition, of a lathering surfactant selected from the group consisting of anionic surfactants, nonionic surfactants, amphoteric surfactants, cationic surfactants or mixtures thereof and a structuring system. The structuring system comprises a non-ionic emulsifier having an HLB of from about 1.4 to about 13 by weight of the multiphase personal care composition, of an associative polymer; and an electrolyte. The benefit phase comprises from about 5 percent to about 30 percent, by weight of the multiphase personal care composition, of hydrophobic benefit material. The present invention differs from this published document in that this publication discloses that fatty acid is not included in such compositions. Therefore it can be inferred that such compositions do not deliver the sensory properties expected from such compositions. [0007] It is thus an object of the present invention to provide for sunscreen compositions that exhibit the consumer preferred watery sensation from such compositions comprising a fatty acid or a ester thereof and a cross-linked acrylic acid polymer. SUMMARY OF THE INVENTION [0008] The present invention relates to a personal care cream composition comprising [0000] (a) 0.1 to 2% by weight of the composition, inorganic particles having a mean particle size in the range of 2 to 500 nm; (b) 0.1 to 2% by weight of the composition, hydrophobic polymeric particles having a mean particle size in the range of 1 to 10 microns; and (c) a cosmetically acceptable base comprising (i) 1 to 8% fatty acid or an ester thereof, by weight of the composition (ii) 0.05 to 1% cross-linked acrylic acid polymer, by weight of the composition; and (iii) water. [0009] It is particularly preferred that the composition has a viscosity in the range of 40,000 to 70,000 cps at 25° C. DETAILED DESCRIPTION OF THE INVENTION [0010] These and other aspects, features and advantages will become apparent to those of ordinary skill in the art from a reading of the following detailed description and the appended claims. For the avoidance of doubt, any feature of one aspect of the present invention may be utilised in any other aspect of the invention. The word “comprising” is intended to mean “including” but not necessarily “consisting of” or “composed of.” In other words, the listed steps or options need not be exhaustive. It is noted that the examples given in the description below are intended to clarify the invention and are not intended to limit the invention to those examples per se. Similarly, all percentages are weight/weight percentages unless otherwise indicated. Except in the operating and comparative examples, or where otherwise explicitly indicated, all numbers in this description and claims indicating amounts of material or conditions of reaction, physical properties of materials and/or use are to be understood as modified by the word “about”. Numerical ranges expressed in the format “from x to y” are understood to include x and y. When for a specific feature multiple preferred ranges are described in the format “from x to y”, it is understood that all ranges combining the different endpoints are also contemplated. [0011] By “A personal care composition” as used herein, is meant to include a composition for topical application to the skin and/or hair of mammals, especially humans. Such a composition may be generally classified as leave-on or rinse off, and includes any product applied to a human body for additionally improving the appearance, cleansing, odor control or general aesthetics. It is more preferably a leave-on product. The composition of the present invention is in the form of cream. “Skin” as used herein is meant to include skin on the face and body (e.g. neck, chest, back, arms, underarms, hands, legs, buttocks and scalp) and especially to the sun exposed parts thereof. The composition of the invention is also of relevance to applications on any other keratinous substrates of the human body other than skin e.g. hair where products may be formulated with specific aim of providing photoprotection. [0012] By particle size, as per the present invention, is meant the average diameter when the particle is substantially spherical. When the particle is not substantially spherical, the particle size refers to the average leading dimension of the particles. In the case of the present invention, the average particle size of the inorganic particles is generally measured using light scattering techniques. In the case of the present invention, the average particle size of the hydrophobic polymeric particles are measured using sieve analysis. [0013] By way of the present invention it is possible to prepare personal care compositions in the viscosity range of 40,000 to 70,000 cps at 25° C. [0014] The present invention relates to a personal care cream composition comprising inorganic particles; hydrophobic polymeric particles; and a cosmetically acceptable base comprising fatty acid or an ester thereof, cross-linked acrylic acid polymer; and water. The composition preferably has a viscosity in the range of 40,000 to 70,000 cps at 25° C. The viscosity of the composition in the above range is measured using a Brookfield viscometer RVT, Model D220, using a T-bar spindle D at 5 RPM, 60 seconds at 25° C. [0015] It is preferred that inorganic particles are selected from titanium dioxide, zinc oxide, mica, iron oxide, a pigment or combinations thereof. More preferably the the inorganic particle is titanium dioxide or zinc oxide. The inorganic particle has a mean particle size in the range of 2 to 500 nm, preferably in the range of 10 to 400 nm, more preferably in the range of 20 to 300 nm. By the particle size herein is meant the primary particle size and not the particle size of the agglomerated mass of particles. The inorganic particle is present in 0.1 to 2%, preferably 0.3 to 1.8%, more preferably 0.5 to 1.5% by weight of the composition. The inorganic particles are preferably coated. Preferred coating materials are stearic acid or alumina. An especially preferred particle for use in the present invention is titanium dioxide under the brand name of MT 700Z available from Tayca. [0016] The composition of the invention comprises hydrophobic polymeric particles. Hydrophobic polymeric particles as per this invention are preferably organic polymers. Hydrophobic polymeric particles as per the present invention are such that when included in an emulsion, these particles substantially partition into the oil phase. The oil phase in an emulsion can be an internal phase for oil in water emulsion, or an external phase for water in oil emulsion. Hydrophobic polymeric particles are preferably selected from polyethylene, polypropylene or silicone resin beads more preferably polyethylene. An especially suitable hydrophobic polymeric particle is sold under the name of LE-1080 from Sumitomo Corpcan be sourced from The hydrophobic polymeric particle is present in 0.1 to 2%, preferably 0.3 to 1.8%, more preferably 0.5 to 1.5% by weight of the composition. [0017] Without wishing to be bound by theory it is believed that the inclusion of the hydrophobic polymeric particles results in the increase of the internal phase volume by enlarging the internal droplet size, which in turn enhances the desired water slip phenomenon during the application under certain shear. [0018] The composition of the invention comprises a cosmetically acceptable base which comprises a fatty acid or an ester thereof. It is more preferably a fatty acid. Most preferred fatty acid is stearic acid. The fatty acid or an ester thereof preferably has 12 to 22 carbon atoms, more preferably 14 to 18 carbon atoms. The composition preferably comprises 1 to 8%, preferably 2 to 5 wt % fatty acid or ester thereof. [0019] The composition as per the invention comprises a cross-linked acrylic acid polymers. They are generally a a homopolymer of acrylic acid with a high molecular weight, which is cross-linked with any of several polyalcohol allyl ethers. They are usually referred to as carbomers. A highly suitable cross linked acrylic acid polymer is available as Acrylpol 980 from AAKO. Cross-linked acrylic acid polymers are preferably included in 0.05 to 1.0%, preferably from 0.1 to 1%, further more preferably from 0.1 to 0.6% by weight of the composition. [0020] An important aspect of the present invention is that the cosmetically acceptable base provides the desired baseline sensorials. It is especially important that the fatty acid or ester thereof is present in 1 to 8% by weight of the composition and the cross-linked acrylic acid polymer is present in 0.05 to 1% by weight of the composition. This unique combination provides the desired watery sensation the consumers expect from such compositions. At lower concentrations of these base materials the consumers experience a sticky sensation and at higher concentrations they experience a heavy sensation that is often observed in highly viscous compositions, both of which are undesirable. In order to get even better sensorials, it is preferred that the weight ratio of the fatty acid or ester thereof to the cross-linked acrylic acid polymer is in the range of 4:1 to 16:1, further more preferably 8:1 to 12:1. [0021] The composition of the invention preferably additionally comprises an oily material. Preferred oily materials are mineral oil, isopropyl myristate, silicone oil or mixtures thereof. The oily material preferably is present in 1-10% by weight of the composition. When mineral oil is present, it is preferred to be included in 1 to 5% by weight of the composition. When silicone oil is present, it is preferred to be included in 0.1 to 2% by weight of the composition. When isopropyl myristate is present, it is preferably included in 1 to 6% by weight of the composition. Without wishing to be bound by theory it is believed that the oily materials are included in the formulation to generate an emulsion structure that improves the application smoothness. When a specific oil has been selected the amount that needs to be included will dictate the optimization of the internal and external phase ratio. [0022] It is preferred that the composition is prepared as an emulsion by way of use of an emulsifier. Suitable emulsifiers are a non-ionic surfactant, anionic surfactant or cationicsurfactant, preferably a non-ionic surfactant. The non-ionic surfactant is preferably selected from the class of fatty alcohol ethoxylates, alkyl phenol ethoxylates or polyoxyethylene sorbitan alkyl esters. Non-ionic surfactant of the fatty alcohol ethoxylates which may be used in the present invention are sold under the generic brand name of Brij. Non-ionic surfactant of the alkyl phenol ethoxylates which may be used in the present invention are sold under the generic brand name of Triton. Non-ionic surfactant of the polyoxyethylene sorbitan alkyl esters which may be used in the present invention are sold under the generic brand name of Tween. [0023] The non-ionic surfactant is present in 0.1 to 5%, preferably 1 to 4% by weight of the composition. [0024] Total amount of emulsifier is preferably included in 0.2 to 5% preferably from 0.5 to 3% by weight of the composition. [0025] The composition for the invention may additionally comprise fatty alcohol which may be preferably included in 0.1 to 2% by weight of the composition. Preferred fatty alcohol is cetyl alcohol. The composition comprises water. Water is preferably included in 30 to 90%, preferably 40 to 85% by weight of the composition. [0026] The composition preferably exhibits a pH in the range of 5.5 to 7.5 as measured at 25° C. [0027] The composition may optionally comprises an organic sunscreen. When present, organic sunscreen may be included in 0.1 to 15%, preferably 0.5 to 8% by weight of the composition. Organic sunscreens are preferably chosen from the following seven major groups: (1) benzophenones, (2) anthranilates, (3) dibenzoylmethanes (4) salicylates, (5) cinnamates, (6) camphores and (7) p-amino benzoic acid (PABA) or their derivatives or mixtures. The organic sunscreens may be of the UV-A or of the UV-B sunscreen types. Preferred UV-A sunscreen is a dibenzoylmethane, triazine, triazone, or benzophenone derivative. A more preferred UV-A sunscreen belongs to the dibenzoylmethane group. When present, this is included in 0.1 to 5% dibenzoylmethane or its derivative. The most preferred dibenzoylmethane derivative is 4-tert.-butyl-4′-methoxydibenzoylmethane. Dibenzoylmethane or its derivative is preferably present in 0.2 to 5%, more preferably 0.4 to 3% by weight of the composition. [0028] The composition of the invention may comprise a UV-B sunscreen. UV-B organic sunscreen is preferably selected from the class of cinnamic acid, salicylic acid, diphenyl acrylic acid or derivatives thereof. A few of the preferred oil soluble UV-B sunscreens which are commercially available and useful for inclusion in the composition of the invention are Octisalate™, Homosalate™, NeoHelipan™, Octocrylene™, Oxybenzone™ or Parsol MCX™. When present, UVB sunscreen is included in 0.1 to 7%, preferably from 0.5 to 6%, more preferably 1 to 5% by weight of the composition. [0029] The composition of the invention may additionally comprise a skin lightening agent. The skin lightening agent is preferably chosen from a vitamin B3 compound or its derivative e.g. niacin, nicotinic acid, niacinamide or other well known skin lightening agents e.g. aloe extract, ammonium lactate, azelaic acid, kojic acid, citrate esters, ellagic acid, glycolic acid, green tea extract, hydroquinone, lemon extract, linoleic acid, magnesium ascorbyl phosphate, vitamins like vitamin B6, vitamin B12, vitamin C, vitamin A, a dicarboxylic acid, resorcinol derivatives, hydroxycarboxylic acid like lactic acid and their salts e.g. sodium lactate, and mixtures thereof. Vitamin B3 compound or its derivative e.g. niacin, nicotinic acid, niacinamide are the more preferred skin lightening agent as per the invention, most preferred being niacinamide. Niacinamide, when used, is preferably present in an amount in the range of 0.1 to 10%, more preferably 0.2 to 5% by weight of the composition. [0030] The composition according to the invention may also comprise other diluents. The diluents act as a dispersant or carrier for other materials present in the composition, so as to facilitate their distribution when the composition is applied to the skin. Diluents other than water can include liquid or solid emollients, solvents, humectants, thickeners and powders. [0031] The compositions of the present invention can comprise a wide range of other optional components. The CTFA Cosmetic Ingredient Handbook, Second Edition, 1992, which is incorporated by reference herein in its entirety, describes a wide variety of non-limiting cosmetic and pharmaceutical ingredients commonly used in the skin care industry, which are suitable for use in the compositions of the present invention. Examples include: antioxidants, binders, biological additives, buffering agents, colorants, thickeners, polymers, astringents, fragrance, humectants, opacifying agents, conditioners, exfoliating agents, pH adjusters, preservatives, natural extracts, essential oils, skin sensates, skin soothing agents, and skin healing agents. [0032] Another aspect of the present invention relates to a method of providing photoprotection to the skin comprising the step of applying a composition of the invention on to the desired surface of skin. [0033] The invention is now further described by way of the following non-limiting examples. EXAMPLES [0034] The following cream formulations were prepared. [0000] Example A Example B Example 1 Ingredients Wt % Wt % Wt % Glycerin 1.00 1.00 1.00 Sodium Hydroxide (solution) 0.05 0.05 0.05 Carbomer (Acrypol 980) 0.4 0.4 0.2 Stearic acid 3 3 3 Cetyl Alcohol 0.5 0.5 0.5 Isopropyl Myrsitate 4 4 4 Mineral oil 1.5 1.5 1.5 Glyceryl monostearate 1.5 1.5 1.5 Dimethicone fluid, 200 cst 0.5 0.5 0.5 Parsol MCX 1.25 1.25 1.25 Parsol 1789 0.4 0.4 0.4 Triethanolamine 1 1 1 Niacinamide 3 3 3 TiO2 MT700Z (1) 0 1.0 1.0 PE beads (2) 0 0.0 0.5 Water To 100 To 100 To 100 (1) TiO2 MT700Z is a sample of titanium dioxide with an average particle size of 80 nm procured from Tayca Corporation. (2) PE beads is a sample of polyethylene beads of average particle size of 6 microns procured from Sumitomo Corporation. [0035] The above three cream samples were subjected to analysis using the following procedure: [0036] MSV is the Maximum Stress Variation, the maximum difference of the measured stress to the Herschel-Bulkley model fitting curve. [0037] Higher the MSV, the farther away the measured curve is from the Herschel-Bulkey model fitting curve. This generally implies that there is a stronger wall slip and therefore a more watery sensorial when the cream is rubbed on to the skin. It is also known that wall slip and watering feel will disappear with increase of friction coefficient. The MSV and Friction coefficient were measured using the following procedure: Viscosity Test [0038] After storage at room temperature (about 25° C.) for 1 day, the viscosity of each sample was measured by a rheometer (Anton Paar Rheometer MCR501, Austria) system using parallel plate geometry (PP50/TG) at 25° C. The gap used was 0.5 mm and the shear rate range was from 0.1 s −1 to 1000 s −1 . The resultant shear stress at high shear rate (from around above 10 s −1 to 1000 s −1 ) was then fitted to the Herschel-Bulkley Model: τ=τ y +K γ & P using the data analysis software of Anton Paar (RheoPlus). The fitting curve was extended to low shear rates. The maximum stress variation (MSV) is defined as the biggest difference between the measured stress and the fitting result from Herschel-Bulkley Model at low shear rates. Film Friction Coefficient Test [0039] The friction coefficient of the film formed by the composition of the present invention was measured at 23° C. and relative humidity of 45% by a home-made instrument, a motor driven mechanical finger, with accelerometers and loading cells. [0040] 0.125 g sample was spread evenly on a bio-skin strip (Color: 30#, ex. BEAU LAX, Co. Ltd., Tokyo, Japan) with size of 2.5 cm×13 cm. After naturally drying for two hours, the bio-skin strip was placed onto the sample station. The mechanical finger with attached piece of glove rubber was used to rub the bio-skin strip with fixed force which is perpendicular to the strip. Loading cells under the strip recorded the normal force experienced by the substrate under the rub of the finger. Then the friction coefficient for the interface between the finger and strip with sample was calculated according to paper by Akay et al. (Wear, Volume 276-277, 2012, Pages 61-69). The friction coefficient for naked bio-skin strip was also measured by the same method without spreading sample. If the friction coefficient of sample film/finger is greater than the naked bio-skin strip/finger, the sample would deliver “draggy” benefits to consumer. [0041] The data on the MSV, viscosity and friction coefficient are summarized for the three samples below: [0000] Example Example B Example 1 MSV (Pa) 34.4 0.0 31.8 Friction Coefficient 0.38 0.60 0.41 MSV 57.9 108 43.7 Viscosity (cps)* 49200 63600 44400 *The viscosity is measured using a Brookfield viscometer RVT, Model D220, using a T-bar spindle D at 5 RPM, 60 seconds at 25° C. [0042] The data in the table above indicates that the value of MSV reduces and the value of friction coefficient increases on inclusion of 1% inorganic particle (TiO 2 ) (Example B) in a base formulation (Example A). These values of Example B are indicative of a less watery feel on rubbing the composition on skin. When additionally 0.5% polyethylene beads are included in the composition (Example 1) the watery feel is recovered as evidenced by the lowered value of friction coefficient and the increase in the value of MSV, with values similar to that of the base formulation (Example A). The inclusion of TiO 2 particles additionally provides the desired sunscreen benefits.

1a

REFERENCE TO PENDING APPLICATIONS This application is a continuation application claiming priority to U.S. patent application Ser. No. 12/268,219, filed Nov. 10, 2008, entitled Extensible Straw for a Disposable Collapsible Drink Mixing Container, which is a continuation-in-part application claiming priority to U.S. patent application Ser. No. 11/900,060, filed Sep. 10, 2007, entitled Extensible Straw for a Disposable Collapsible Drink Mixing Container, now U.S. Pat. No. 7,823,802, issued Nov. 2, 2010, which is a continuation-in-part application claiming priority to U.S. patent application Ser. No. 11/397,219, filed Apr. 4, 2006, entitled Disposable Collapsible Drink Mixing Container. REFERENCE TO MICROFICHE APPENDIX This application is not referenced in any microfiche appendix. BACKGROUND OF THE INVENTION This invention relates generally to containers for beverages and more particularly concerns disposable containers for storing and mixing drink ingredients with water or other liquids and the straws used for dispensing the mixed beverage from the container to the consumer. There are a variety of known disposable containers for carrying beverages in liquid form for consumption directly from the container. Some use straws, stored either inside or outside the container. There are also collapsible containers for carrying ingredients in a solid or concentrated liquid to be mixed with water or other liquids at the time of consumption. There are several problems and inconveniences inherent in the configuration of these known disposable and collapsible containers. The disposable containers store the beverage in a liquid, ready-to-drink state. Consequently, the container takes on the full weight and volume of the ready-to-drink beverage whether or not the consumer is ready to drink. This weight and volume may not pose a significant disadvantage if only one container is being transported but, for example, to a hiker or soldier on an extended trip with no source of flavored or fortified drinks along the way, the weight and volume of multiple containers becomes a burden. Furthermore, known disposable containers generally cannot be resealed and have no suitable access for adding liquid. Those disposable containers which require straws do not have straw-to-container accesses which satisfactorily minimize leakage during use. Those which do not require straws have drink dispensing ports which are not satisfactory in terms of spillage of beverage during drinking or which would make satisfactory collapse of the container difficult if not impossible. The collapsible containers for drink ingredients are generally intended for repeated use and are not intended to be disposable after a single use. While they are collapsible to some extent, they do not collapse sufficiently to make it feasible to carry many of them at the same time. Since they are reusable, they are generally made of too expensive and heavy materials and of too complex structural configuration for one-time-only use. The straws commonly in use for extracting beverages from collapsible and disposable beverage containers are supplied external to the container and are easily lost. They are inserted into the container by puncturing a hole through the container wall at a specific location near or at the top of the container, and therefore, require a sharp point on one end, an undesirable feature especially for children. The containers are difficult to transport without leakage if the beverage in the container is only partially consumed, generally requiring that the collapsible beverage container stay in an upright position and not be compressed. This problem is all the more compelling if the container is used by a very active person such as a biker, hiker or soldier. Known telescoping straws do not provide for sealing the bottom end of the straw to prevent the entrance of liquid when the fully- or partially-filled beverage container is transported with the straw in place. Known telescoping straws do not provide adequate seals against flow of liquid between the inner and outer tubular straw members. Caps are not supplied with the straws commonly used with collapsible and disposable beverage containers and, when they are supplied they do not adequately seal the container for transport with the straw in place. It is, therefore, an object of this invention to provide a disposable beverage ingredients container which collapses to a substantially flat condition. Another object of this invention is to provide a disposable beverage ingredients container which stores beverage ingredients in a solid or condensed liquid state. Still another object of this invention is to provide a disposable beverage ingredients container into which the consumer can add water or other liquids at the time of consumption. It is also an object of this invention to provide a disposable beverage ingredients container in which stored ingredients can be mixed with water or other liquids at the time of consumption. A further object of this invention is to provide a disposable beverage ingredients container from which the consumer can drink directly without a straw. Yet another object of this invention is to provide a disposable beverage ingredients container which includes a straw. Another object of this invention is to provide a disposable beverage ingredients container which has a leakage resistant straw-to-container access. Still another object of this invention is to provide a disposable beverage ingredients container which has a spillage resistant filling port. It is also an object of this invention to provide a disposable beverage ingredients container which has a filling port which can be resealed. A further object of this invention is to provide a disposable beverage ingredients container with a straw that can be closed. Yet another object of this invention is to provide a disposable beverage ingredients container which is simply and inexpensively constructed. And it is an object of this invention to provide a disposable beverage ingredients container which may be resealable for future use. Another object of this invention is to provide a straw which can be incorporated as an integral part of a collapsible or disposable beverage container. Still another object of this invention is to provide a straw which does not require a sharp point on one end. It is also an object of this invention to provide a straw that establishes a seal between the straw and the beverage container wall. A further object of this invention is to provide a telescoping straw which seals against liquid entrance or exit on both ends of the straw when it is in a collapsed condition. Yet another object of this invention is to provide a telescoping straw which effectively seals against flow of liquid between the inner and outer tubular straw members. Another object of this invention is to provide a telescoping straw which cannot be extended beyond a predetermined limit. Still another object of this invention is to provide a telescoping straw equipped with a cap which fully encloses the top of the straw. And it is an object of this invention to provide a telescoping straw equipped with a cap provides multiple seals to prevent the escape of liquid. SUMMARY OF THE INVENTION In accordance with the invention, a drink has a liquid-tight*film pouch which is collapsible into a substantially flat condition. Drink ingredients in a solid or condensed liquid state can be stored in or added to the pouch through an opening in an upper portion of the pouch. A cover with a liquid tight seal closes the opening. The opening is located and the cover contoured to conform with the desired substantially flat storage condition. Preferably, the pouch has opposed front and rear panels sealed together along their side edges and top and bottom panels with their perimeters sealed to the top and bottom perimeters of the front and rear panels. The top and bottom panels are foldable across their widths into the substantially flat condition and are preferably elliptical so the pouch assumes a substantially ovate horizontal cross-section condition as it is filled with liquid. In preferred embodiments, the fill opening may be approximately centered on and have a perimeter on one side of the major axis of the elliptical top panel or may be spaced away from the minor axis with its perimeter on one side of the major axis of the elliptical top panel. The fill opening has a resealable cover which may be a plug insertable into the opening. In one embodiment, the plug and the opening have co-operable means on peripheral edges thereof for resisting inadvertent removal of the plug from the opening. For example, the cover may have a flat, thin, substantially rigid collar fixed around a perimeter of the opening and be hinged to a flat, thin, substantially rigid plug insertable into the collar. Alternatively, the fill opening can be covered with an adhesive strip. The pouch may also have a dispense opening in its top panel, preferably with its perimeter on one side of the major axis of the top panel. The dispense opening may have a straw extending through it. Preferably, the straw has a first tubular member with a closed bottom end and at least one aperture through a lower portion of its side wall and a second tubular member longer than and in reciprocally slidable abutment within the first tubular member. The second tubular member slides between a closed condition with an open bottom end of the second tubular member seated on the closed bottom end of the first tubular member and an open condition with the open bottom end of the second tubular member above an uppermost of the second tubular member apertures. Preferably, the tubular members have means on their abutting surfaces for sealing the annulus between them against flow of liquid into the bottom of the second tubular member when the bottom of the second tubular member is seated on the bottom of the first tubular member. The sealing means may, for example, be a mating annular ring and groove on the tubular members in the annulus below the lowermost aperture of the first tubular member or a conical protrusion in the bottom of the first tubular member for seating the open bottom of the second tubular in the closed condition. The straw may also include means on abutting surfaces of the tubular members for sealing the annulus against upward flow of liquid to a top of the first tubular member. This may also be accomplished by one or more sets of mating annular rings and grooves. A cap may be used to close the open upper end of the second tubular member against upward flow of liquid. If so, it is preferred that the cap is attached to the pouch by a flexible connector so that the cap can be mounted on and removed from the upper end of the second tubular member. Means is also provided for locking the tubular members in the closed condition, such as mating male and female threads on abutting surfaces of the tubular members. Whether the container has separate fill and dispense openings, has a common fill and dispense opening, or uses or does not use a straw, it will store the mixing ingredients in substantially flat packages which are easily stacked on each other for transport. A preferred embodiment of the straw has an outer tubular member and an inner tubular member longer than the outer tubular member. The outer tubular member has a closed bottom end and at least two apertures through the lower portion of its side wall. The inner tubular member has an upper portion of outer diameter which is reciprocally slidable in abutment within the upper portion of the outer tubular member. The inner tubular member slides between a fully-closed condition when its open bottom end is seated on the closed bottom end of the outer tubular member and a fully-opened condition when its open bottom end is above an uppermost of the apertures in the outer tubular member. Preferably, the closed bottom end of the outer tubular member has a dome-like protrusion extending upwardly for at least partial insertion into the open bottom end of the inner tubular member so that the protrusion and the open bottom end can mate to provide a seal against flow of liquid into the open bottom end in the fully-closed condition. It is further preferred that the annulus between the tubular members be sealed against flow of liquid when the bottom of the inner tubular member is seated on the bottom of the outer tubular member. Abutting surfaces of the tubular members are configured for this purpose by inclusion of a pair of co-operable tapered surfaces, one on the inner wall of the outer tubular member and another on the outer wall of the inner tubular member. The pair mates not lower than above the uppermost of the apertures of the outer tubular member so as to prevent flow in the annulus above the mating point. The tapers are also dimensioned to provide a concentric space in the annulus below their mating point so that liquid flows through the apertures into the inner tubular member as soon as the inner tubular member has been withdrawn from the fully closed condition. The annulus between the inner and outer walls of the tubular members may further be sealed against flow of liquid when the bottom of the inner tubular member is not fully closed. An annular bead on either the outer wall of the inner tubular member or the inner wall of the outer tubular member above the tapered surface seal will serve this purpose. A top end seal may be formed by inclusion of another pair of tapered surfaces, one on the inner wall of the outer tubular member and another on the outer wall of the inner tubular member. This top end pair of tapered surfaces mates proximate the upper end of the outer tubular member and helps assure that liquid will not inadvertently leak from the straw outside of the container. To prevent complete withdrawal of the inner tubular member from the outer tubular member, an annular groove in the inner wall of the outer tubular member co-operates with a ring of flexible radial tabs which extend inwardly from the circumferential wall of the annular groove and into flapping contact with the outer wall of the inner tubular member during reciprocal motion of the inner tubular member. An annular slot in the outer wall of the inner tubular member receives the tabs when the annular slot and the annular groove are aligned. The tabs have upper surfaces which, when forces on the tabs are released in the slot, abut the upper surface of the annular groove. This prohibits disengagement of the tabs from the annular slot. Thus, the elevations of the tabs and slot on their respective tubes set the predetermined limit beyond which the inner tubular member cannot be withdrawn. The open top of the inner tubular member is preferably covered and uncovered by use of a cap. In a preferred embodiment of the cap, a plug in the top of the cap inserts into the open top end of the inner tubular member. Complementary threads on the inside of the cap sidewalls and the outside of the outer tubular member draw the cap plug and the closed bottom end of the outer tubular member toward each other cap is tightened on the threads. This simultaneously seals the open top and bottom ends of the inner tubular member in the fully-closed condition. An annular flange may be provided around the outer tubular member and positioned to lie below the cap in the fully-closed condition. A tether connects the cap to the annular flange. In conjunction with the cap, the straw may also have another pair of top end tapered surfaces co-operable with the first top end tapered surfaces. The added pair has one tapered surface on the outer wall of the outer tubular member and the other tapered surface on the inner wall of the cap. This pair of tapered surfaces also mates at the upper end of the outer tubular member so that the upper end of the outer tubular member is squeezed between these pairs of tapers in the fully-closed condition to tightly seal the straw assembly. In yet another embodiment, the straw has a body with a passage extending longitudinally through it from top to bottom. An outer tubular member depends from the body. The bottom end of the outer tubular member is closed and the side wall of the outer tubular member has at least one longitudinal slot, and preferably two diametrically opposed longitudinal slots, extending upwardly from its bottom end. An inner tubular member extends through the body and into the outer tubular member. The diameter of the inner tubular member is such as to be engaged in and snugly reciprocally slide in the body passage. The diameters of the inner and outer tubular members are such as to create an annular passage between them. The inner tubular member reciprocates between a fully-closed condition in which the open bottom end of the inner tubular member is seated on the closed bottom end of the outer tubular member and a fully-opened condition in which the open bottom end of the inner tubular member is raised above the closed bottom end of the outer tubular member. Preferably, the closed bottom end of the outer tubular member has an upwardly extending dome-like protrusion which at least partially inserts into and mates with the open bottom end of the inner tubular member to provide a seal against flow of liquid into the open bottom end in the fully-closed condition. Also preferably, an outward flare on the open bottom end of the inner tubular member cooperates with the dome-like protrusion to provide the seal. During withdrawal of the inner tubular member from the outer tubular member, the flare will eventually mate with a tapered surface on an inner wall of the body to prevent further withdrawal of the inner tubular member from the body. A cap with a top and sidewalls covers the open top end of the inner tubular member. Complementary threads on the inside of the cap sidewalls and the outside of the body draw the cap and the closed bottom end of the outer tubular member toward each other during tightening rotation of the threads. A plug in the top of the cap is inserted into the open top end of the inner tubular member as the straw comes into the fully closed condition. Thus the cap plug and outer tubular member closed bottom simultaneously seal the open top and bottom ends of the inner tubular member when the straw is in the fully-closed condition. Complementary tapers on the outside wall of the body above the threads and on the inside wall of the cap above the threads are also drawn into abutment with each other to provide a seal between the cap and the body when the straw is in the fully-closed condition. Preferably, to provide tamper-evident protection, an annular flange is provided on the body below the threads and the cap has a breakaway portion on its bottom end engaged on the flange so that the breakaway portion is separated from the cap the first time the cap is unscrewed from the body. A tether connects the cap to the breakaway portion. The outer surface of the body is adapted for liquid-tight connection to a liquid container with the outer tubular member inside the container and the upper portion of the body outside of the container. BRIEF DESCRIPTION OF THE DRAWINGS Other objects and advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which: FIG. 1 is a front elevation view of an embodiment of the container with a straw; FIG. 2 is a bottom plan view of the container of FIG. 1 ; FIG. 3 is a top plan view of the container of FIG. 1 ; FIG. 4 is a perspective view of a flip-cap fill opening cover of the container of FIG. 1 ; FIG. 5 is a top plan view of another embodiment of the container with an adhesive strip fill opening cover; FIG. 6 is a perspective view of a typical straw for use with various embodiments of the container; FIG. 7 is a front elevation view of another embodiment of the container without a straw; FIG. 8 is a front elevation view of another embodiment of the container with a straw; FIG. 9 is a perspective view of the inner tubular member of the straw of FIG. 8 ; FIG. 10 is a perspective view of the fill hole insert of the container of FIG. 8 ; FIG. 11 is a perspective view of the outer tubular member and screw cap of the container of FIG. 8 ; FIG. 12 is a perspective view of a conical seal embodiment of the straw; FIG. 13 is a cross-sectional view of a preferred embodiment of the straw in the fully closed condition taken along a diametric plane bisecting the outer tubular member apertures and extending through the cap tether with the straw; FIG. 14 is an enlarged view of the area 14 of FIG. 13 ; FIG. 15 is an enlarged view of the area 15 of FIG. 13 ; FIG. 16 is a front elevation view illustrating the withdrawal limiting mechanism at the predetermined withdrawal limit of the straw; FIG. 17 is a front elevation view illustrating a modification of the flange connecting the straw of FIG. 13 to a container; FIG. 18 is a front elevation view with parts broken away of another embodiment of the straw; FIG. 19 is a side elevation view with parts broken away of the straw of FIG. 18 ; FIG. 20 is a diametric cross-sectional view of the straw of FIG. 18 ; FIG. 21 is an exploded view of the area 21 - 21 of FIG. 20 ; FIG. 22 is a front elevation view of the body and outer tubular member of the straw of FIG. 18 ; FIG. 23 is a cross-sectional view taken along the line 23 - 23 of FIG. 22 ; FIG. 24 is a cross-sectional view taken along the line 24 - 24 of FIG. 22 ; FIG. 25 is a diametric cross-sectional view transverse to the diametric view of FIG. 20 ; FIG. 26 is a diametric cross-sectional view of the inner tubular member of the straw of FIG. 18 ; FIG. 27 is an exploded view of the area 27 - 27 of FIG. 18 ; and FIG. 28 is an exploded diametric cross sectional view with parts broken away of an alternate embodiment of the body and an associated container fitment. While the invention will be described in connection with preferred embodiments thereof, it will be understood that it is not intended to limit the invention to those embodiments or to the details of the construction or arrangement of parts illustrated in the accompanying drawings. DETAILED DESCRIPTION Turning to FIGS. 1-3 , a disposable container 10 for mixing and drinking liquids made by dissolving powdered ingredients or drink mixing ingredients in other than powdered form in water or other liquid is formed from a liquid-tight film pouch 11 which is collapsible into a substantially flat condition. The powdered drink ingredients, or drink mixing ingredients in other than powdered form, may be packaged in the pouch 11 or added to the pouch at the time of mixing. As seen in FIG. 3 , the pouch 11 has a fill opening 13 in its upper portion and a means for closing 15 the fill opening with a liquid tight seal. The fill opening 13 provides access to the pouch 11 for introduction of the ingredients and liquid into the pouch 11 for mixing and may also be used for dispensing the mixed drink from the pouch 11 . The location of the fill opening 13 and the contour of the closing means 15 are coordinated for conformance of the closing means 15 with the desired substantially flat condition of the pouch 11 in its storage condition. Continuing to look at FIGS. 1-3 , the pouch 11 has opposed front and rear panels 21 and 23 which are sealed together along their side edges 25 and 27 and top and bottom panels 31 and 33 which are sealed along their perimeters to the top and bottom perimeters 35 and 37 of the front and rear panels 21 and 23 . As best seen in FIGS. 2 and 3 , the top and bottom panels 31 and 33 fold across their widths into the substantially flat condition. As seen in FIG. 3 , the fill opening 13 is in the top panel 31 . The sealed top and bottom perimeters 35 and 37 of the pouch 11 are, as shown, preferably elliptical and fold along their major axes 29 and 39 so that the flat pouch 11 assumes a substantially ovate horizontal cross-section condition as it is being filled with liquid. As shown, the perimeter of the fill opening 13 is entirely on one side of the major axis 29 of the ovate cross-section. The fill opening 13 may, as seen in FIG. 3 , be spaced from or, as seen in FIG. 5 , be centered on, the minor axis 41 of the top panel 31 . As seen in FIGS. 3 and 4 , a flip-cap closing means 43 for the fill opening 13 has a pair of flat, thin rigid panels 45 and 47 connected by a hinge 49 . One of the panels 45 has a plug 51 with a peripheral groove 53 and the other panel 47 has an opening 55 defining a collar 57 for co-operable engagement in the groove 53 of the plug 51 to resist inadvertent removal of the plug 51 from the fill opening 13 . The collar 57 is dimensioned to concur with the fill opening 13 and the collar panel 47 is fixed to the pouch top panel 31 with the fill opening 13 and collar 57 aligned. The collar panel 47 also has a latch 59 which engages the unhinged end 61 of the plug panel 45 when the collar 57 and the perimeter of the fill opening 13 are engaged in the plug groove 53 . The rigidity of the panels 45 and 47 facilitates manipulation of the flip-cap closure 43 and firm engagement of the plug 51 and latch 59 . The location and substantially flat contour of the plug 51 permit conformance of the plug 51 to the substantially flat storage condition of the pouch 11 in both the plug-inserted condition and the plug-removed condition. Looking at FIG. 5 , the fill opening 13 may alternatively be covered by a flap 62 with a pull tab 63 having a base 65 permanently fixed to the container top panel 31 . The base 65 has an opening aligned with the fill hole 13 . The flap 62 initially closes the fill hole 13 by use of an outer adhesive seal 67 . Once opened, a peel-off flap 68 can be removed to expose an inner adhesive seal 69 under the flap 68 used to close the opened fill hole 13 . As shown, the fill opening 13 is disposed with its perimeter on one side of the major axis 29 of the pouch top panel 31 and centered on the minor axis 41 of the top panel 31 . As seen in FIGS. 3 , 5 and 7 , the same opening 13 can be used without a straw for both filling and dispensing and, for drinking without a straw, the top panel 31 may preferably be configured to provide a taper 71 to an opening below the minor axis 41 of the top panel 31 . This facilitates manipulation of the pouch 11 during drinking and filling to an efficient flow configuration. Returning to FIG. 3 , another opening 73 may be provided in the pouch 11 , as shown proximate one end of the top panel 31 with its perimeter on the major axis 29 of the panel 31 , for dispensing the mixed drink from the pouch 11 . Looking at FIG. 1 , a straw 81 extends through the dispense opening 73 to proximate the bottom panel 33 of the pouch 11 . The straw 81 , best seen in FIGS. 6 and 8 - 11 , has an outer tubular member 83 with an open upper end 85 and a closed bottom end 87 . At least one aperture 89 through the lower portion of the side wall of the outer tubular member 83 admits liquid from the pouch 11 into the outer tubular member 83 . The straw 81 also has an inner tubular member 91 longer than the outer tubular member 83 . The inner member 91 slides reciprocally in abutment within the outer tubular member 83 between a closed condition in which the open bottom 93 of the inner tubular member 91 is seated on the closed bottom 87 of the first tubular member 83 and an open condition in which the open bottom 93 of the inner tubular member 91 is positioned above the uppermost aperture 89 in the outer tubular member 83 . In the closed condition, liquid cannot freely pass through the apertures 89 in the outer tubular member 83 into the annulus 95 between the tubular members 83 and 91 or into the bottom 93 of the inner tubular member 91 from the annulus 95 . The resulting labyrinth effectively blocks flow of liquid into the inner tubular member 91 . In the open condition, liquid passes freely through every aperture 89 in the outer tubular member 83 and into the bottom 93 of the inner tubular member 91 . Between the open and closed conditions, liquid flows through exposed portions of the apertures 89 in the outer tubular member 83 into the bottom 93 of the inner tubular member 91 . To further assure a seal of the annulus 95 , means such as sets of mating annular rings and grooves 97 can be positioned on the abutting surfaces of the tubular members 83 and 91 . In the closed condition, at least one annular ring and groove set 97 , located below the lowermost aperture 89 in the outer tubular member 83 , mate at the same time that the bottom 93 of the inner tubular member 91 seats on the bottom 87 of the outer tubular member 83 . In the open condition, at least one mating annular ring and groove set 97 is located above the uppermost aperture 89 in the outer tubular member 83 . Seal of the annulus 95 may be accomplished in other ways such as, for example as seen in FIG. 12 , a conical protrusion 101 in the bottom 87 of the outer tubular member 83 can seat the open bottom 93 of the inner tubular member 91 in the closed condition. The open upper end 99 of the inner tubular member 91 can also be provided with a cap 103 to block upward flow of liquid through the inner tubular member 91 . The cap 103 can be attached by a flexible connector 105 to a mounting ring 107 on the straw 81 , as seen in FIGS. 6 and 8 , or to the pouch 11 , so that the upper end 99 of the inner tubular member 91 can be opened and closed as needed. Going back to FIGS. 1 and 3 , the junction of the perimeter of the dispense opening 73 with the perimeter of the outer tubular member 83 of the straw 81 preferably has a liquid flow preventing seal 109 , perhaps accomplished by heat welding. Alternatively, as seen in FIGS. 8-11 , an insert 111 with a threaded neck 113 aligned with the fill opening 13 of any embodiment and a base 115 fixed to the pouch 11 can be covered with a screw cap 117 . Such a closure can be used to cover either the fill or dispense openings 13 or 73 . In a straw type embodiment of the container 10 , either the screw cap 117 is provided with an opening 119 which snugly girts the outer tubular member 83 of the straw 81 or the screw cap 117 is integrally molded with the outer tubular member 83 of the straw 81 . The structure and operation of the tubular members 83 and 91 is otherwise substantially as hereinbefore described. The open upper end 99 of the inner tubular member 91 can also be covered with its own cap 103 , also as hereinbefore described. The tubular members 83 and 91 may also be locked in the closed condition, for example and as shown in FIG. 6 , by use of mating male and female threads 121 and 123 on abutting surfaces of the tubular members 83 and 91 so that, in the closed condition, the inner tubular member 91 can be rotated into a sealed threaded engagement with the outer tubular member 83 . The locations of openings 13 and 73 , the use of a straw 81 and the types of opening covers 43 and 63 illustrated herein are interchangeable to achieve a variety of containers in keeping with the invention. The thickness, location and orientation of the straw 81 and the various covers 43 and 63 and caps 103 and 117 described above allow the container to maintain its desired substantially flat storage condition. In the screw cap straw embodiment of FIG. 8 , it may be desirable to remove the tubular members 83 and 91 from the cap 117 for storage so that the base 115 of the insert 111 will follow the fold 29 of the top panel 31 of the pouch 11 into the storage condition. Turning to FIGS. 13-17 , a preferred embodiment of the straw is illustrated. The straw 200 has an outer tubular member 210 , an inner tubular member 250 and a cap 270 . The Outer Tubular Member Looking at FIG. 13 , the outer tubular member 210 has a constant outer diameter, an upper portion 211 of constant inner diameter and a lower portion 213 of constant inner diameter smaller than the inner diameter of the upper portion 211 . At least two apertures, as shown upper and lower large apertures 215 and 217 , are vertically spaced and aligned proximate the closed bottom 219 of the outer tubular member 210 to admit liquid from the container C into the straw. The apertures 215 and 217 are ovate with their major axes aligned coaxially with the outer tubular member 210 . The decrease in inner diameter is accomplished by an inside wall taper 221 at the top of the upper aperture 215 , best seen in FIG. 14 . As best seen in FIG. 15 , the outer tubular member 210 also has an inside wall annular bubble or bead 223 spaced above the taper 221 . The outer tubular member 210 has external threads 225 at its top end 227 . Inside and outside wall tapers 229 and 231 gradually narrow the thickness of the upper portion 211 of the outer tubular member 210 at its top end 227 . The closed bottom end 219 of the outer tubular member 210 has a dome-like protrusion 233 which extends upwardly into the outer tubular member 210 . As best seen in FIGS. 13 and 16 , the outer tubular member 210 also has an annular flange 235 proximate and below its external threads 225 . The annular flange 235 is thick enough to house an annular groove 237 in the inside wall of the outer tubular member 210 . A ring of resiliently flexible tabs 239 extends radially inwardly from the circumferential back wall of the annular groove 237 . As is seen in FIG. 16 , when no force is applied to the tabs 239 , the tabs 239 extend beyond the inner diameter of the upper portion 211 of the outer tubular member 210 . The upper surfaces of the tabs 239 in the no-force applied condition of FIG. 16 abut the top wall of the groove 237 . The bottom wall of the groove 237 is downwardly sloped, so the tabs 239 can flex between a downwardly arced condition entirely within the groove 237 , as seen in FIG. 13 , and a substantially horizontal condition protruding from the groove 237 , as seen in FIG. 16 . The annular flange 235 shown has a wide diameter base 241 to facilitate mounting the straw on the container C and a channel 243 in its outer circumference above the base 241 for securing an O-ring-like member 245 to the outer tubular member 210 . As seen in FIG. 17 , illustrating a modification of the flange 235 , the flange 235 may be formed in two mating segments 247 and 249 . As shown, the outer and inner segments 247 and 249 are threadedly engaged. Other engagement methods, such as a tab-slot combination, could be used. Because of the mating combination, there is no need for a separate fill hole in the top panel of the container C. Filling the container C can be accomplished by unscrewing or otherwise separating the mated flange segments 247 and 249 , removing the detached portion of the straw with the inner portion 249 of the flange 235 from the container C, filling the container C through the opening resulting from the removal of the inner portion 249 of the flange 235 and reinstalling the straw and inner flange 249 in the outer flange portion 247 . As shown, mating tapered surfaces 248 may be provided on the top of the flange portions 247 and 249 to seal against leakage of liquid when the flange portions 247 and 249 are fully screwed together or otherwise engaged. The Inner Tubular Member As seen in FIG. 13 , the inner tubular member 250 , which is longer than the outer tubular member 210 , has a constant inner diameter, an upper portion 251 of constant outer diameter, an intermediate portion 253 of constant outer diameter smaller than the outer diameter of the upper portion 251 and a lower portion 255 of constant outer diameter smaller than the outer diameter of the intermediate portion 253 . The outer diameter of the intermediate portion 253 of the inner tubular member 250 is such that the intermediate portion 253 of the inner tubular member 250 is reciprocally slidable in abutment within the upper portion 211 of the outer tubular member 210 . Preferably, the outer diameter of the intermediate portion 253 is so coordinated to the inner diameter of the outer tubular member 210 as to allow reciprocation of the inner tubular member 250 with minimal exertion of force while maximizing the resistance to flow of liquid between the outer tubular member 210 and the inner tubular member 250 . The decreases in outer diameter of the inner tubular member 250 are accomplished by outside wall tapers 257 and 259 . Looking at FIG. 14 , the lower taper 257 is positioned to mate with the taper 221 at the top of the upper aperture 215 of the outer tubular member 210 when the open bottom end 261 of the inner tubular member 250 is fully seated on the dome-like protrusion 233 on the closed bottom end 219 of the outer tubular member 210 . In this, the fully closed condition, the dome-like protrusion 233 seals the otherwise open bottom end 261 of the inner tubular member 250 and the mating tapers 221 and 257 on the outer and inner tubular members 210 and 250 seals off the annulus 263 between the tubular members 210 and 250 above the mating tapers 221 and 257 . The narrower diameter at the lower portion 255 of the inner tubular member 250 affords a concentric space 265 in the annulus 263 below the mating tapers 221 and 257 and across the apertures 215 and 217 in the outer tubular member 210 to prevent creation of a vacuum between the tubular members 210 and 250 as the inner tubular member 250 is withdrawn and to facilitate immediate flow of liquid through the apertures 215 and 217 into the open bottom end 261 of the inner tubular member 250 as soon as the straw is not in the fully closed condition. Looking at FIG. 13 , the upper taper 259 of the inner tubular member 250 is positioned to mate with the taper 229 at the top end 227 of the outer tubular member 210 when the open bottom end 261 of the inner tubular member 250 is fully seated on the dome-like protrusion 233 on the closed bottom end 219 of the outer tubular member 210 . This mating seals the annulus 263 to prevent leakage of any fluid at the top end 227 of the outer tubular member 210 . An annular slot 267 is positioned in the outside wall of the intermediate portion 253 of the inner tubular member 250 . Preferably, the slot 267 is above the annular bead 223 on the inside wall of the outer tubular member 210 and below the flange 235 on the outer tubular member 210 when the straw is in the fully closed condition as seen in FIG. 13 . The bead 223 seals the annulus 263 against flow of liquid when the inner tubular member 250 is withdrawn from the fully closed condition. As the inner tubular member 250 is withdrawn, the slot 267 will slide upwardly only until it comes into alignment with the ring of tabs 239 on the outer tubular member 210 . At this point, as seen in FIG. 16 , the tabs 239 will flap upwardly into the slot 267 until the top surfaces of the tabs 239 abut the top surface of their groove 237 in the outer tubular member 210 and the bottom surface of the slot 267 abuts the bottom surfaces of the tabs 239 , preventing further withdrawal of the inner tubular member 250 . Thus, the elevations of the tabs 239 and slot 267 on their respective tubular members 210 and 250 set the predetermined limit beyond which the inner tubular member 250 cannot be withdrawn. Preferably, when the inner tubular member 250 is withdrawn to the maximum limit, the open bottom end 261 of the inner tubular member 250 will still be substantially below the annular groove 237 in the outer tubular member 210 . It is also preferred that, at this maximum withdrawal, the inner tubular member 250 will have been extended approximately 2″ above the fully closed condition. The inner tubular member 250 has an open top end 269 at which a consumer applies suction to draw liquid from the container C when the straw is not in the fully closed condition. The Cap As seen in FIG. 13 , the cap 270 has a top 271 and sidewalls 273 with internal threads 275 on the open bottom of the cap 270 . The internal threads 275 mate with the external threads 225 on the outer tubular member 210 to close the straw and seal against leaking to the outside of the cap 270 . The cap 270 has an inside taper 277 immediately above the internal threads 275 which mates with the outside wall taper 231 at the top end 227 of the outer tubular member 210 to further assure the tight seal of the cap 270 . Furthermore, if, as shown, the inner tubular member 250 has an upper portion 251 which extends into the cap 270 , the top end 227 of the outer tubular member 210 will be squeezed between the pairs of taper 259 and 277 on the inner tubular member 250 and the cap 270 in the fully closed condition to enhance the seal. The height of the cap 270 is such that top 271 of the cap 270 will close the open top end 269 of the inner tubular member 250 in the fully closed condition. A plug 279 , as shown an inverted cone, extends downwardly from the top 271 of the cap 270 into the open top end 269 of the inner tubular member 250 to enhance this seal in the fully closed condition. In this configuration, tightening of the complementary threads 275 and 225 on the inside of the cap sidewalls 273 and the outside of the outer tubular member 210 draws the cap plug 279 and the closed bottom end 219 of the outer tubular member 210 toward each other. This simultaneously seals the open top and bottom ends 269 and 261 of the inner tubular member 250 in the fully-closed condition. At the same time, the co-operating tapers 221 and 257 on the outer and inner tubular members 210 and 250 and the annular bead 223 seal the annulus 263 . Annular flanges 281 and 283 on the cap 270 provide a channel 285 for securing an O-ring-like member 287 to the cap 270 . A tether 289 extends between the outer tubular member O-ring-like member 245 and the cap O-ring-like member 287 so that the cap 270 will not be inadvertently lost. The tether 289 should be long and flexible enough to facilitate complete and easy application and removal of the cap 270 . The annular bead 223 could be on the outside wall of the inner tubular member 250 rather than on the inside wall of the outer tubular member 210 . The various seals at the mating pairs of tapers 221 and 257 , 229 and 259 and 231 and 277 , at the bead 223 , at the bottom end dome-like member 233 , at the cap plug 279 and at the mating taper 248 of a two piece flange should be capable of preventing leakage when the liquid filled container is subjected to a minimum pressure predetermined according to intended use. Straw with Slotted Outer Tubular Member Turning to FIGS. 18-27 , another embodiment of the straw is illustrated. As seen in FIGS. 18-20 , the straw 300 has a body 310 , an outer tubular member 340 , an inner tubular member 360 and a cap 380 . The body 310 and outer tubular member 340 are best seen in FIGS. 22-25 . The body 310 has a passage 311 extending longitudinally through it from top 313 to bottom 315 . The outer tubular member 340 depends from the body 310 and has a passage 341 aligned and in communication with the passage 311 through the body 310 . The bottom end 343 of the outer tubular member 340 is closed by a wall 345 . The side wall 347 of the outer tubular member 340 has at least one, and as shown two diametrically opposed, longitudinal slots 349 which extend from the bottom 315 of the body 310 to the bottom end 343 of the outer tubular member 340 . The inner tubular member 360 , best seen in FIG. 26 , extends through the body passage 311 into the outer tubular member passage 341 , as seen in FIGS. 18-21 . The outer diameter 361 of the inner tubular member 360 is such as to be engaged in and snugly reciprocally slide in the body passage 311 . The outer diameter 361 of the inner tubular member 360 and the inner diameter 341 of the outer tubular member 340 are such as to create an annular passage 301 between them. The inner tubular member 360 reciprocates between a fully-closed condition, as seen in FIG. 20 , in which the open bottom end 363 of the inner tubular member 360 is seated on the closed bottom end 343 of the outer tubular member 340 , and a fully-opened condition in which the open bottom end 363 of the inner tubular member 360 is raised above the closed bottom end 343 of the outer tubular member 340 . The slots 349 in the outer tubular member 340 allow liquid to enter the lower part of the inner tubular member 360 as it is withdrawn to the fully-opened condition. Preferably, looking at FIG. 20 , the closed bottom end 343 of the outer tubular member 340 has an upwardly extending dome-like protrusion 353 which at least partially inserts into and mates with the open bottom end 363 of the inner tubular member 360 to provide a seal against flow of liquid into the open bottom end 363 of the inner tubular member 360 in the fully-closed condition. Also preferably, an outward flare 365 on the open bottom end 363 of the inner tubular member 360 cooperates with the dome-like protrusion 353 to provide the seal in the fully-closed condition. During withdrawal of the inner tubular member 360 from the outer tubular member 340 , the flare 365 will eventually mate with a tapered surface 317 on an inner wall 319 of the body 310 to prevent further withdrawal of the inner tubular member 360 from the body 310 . Turning to FIGS. 18-20 and 27 , the cap 380 has a top 381 and sidewalls 383 and covers the open top end 367 of the inner tubular member 360 . In the embodiment shown, complementary threads 385 and 321 on the inside of the cap sidewalls 383 and the outside of the body 310 draw the cap 380 and the closed bottom end 343 of the outer tubular member 340 toward each other during tightening rotation of the threads 385 and 321 . Complementary slots and tabs (not shown) could be used in place of the complementary threads 385 and 321 . A plug 387 , best seen in FIG. 20 , in the top of the cap 380 is inserted into the open top end 367 of the inner tubular member 360 as the straw 300 comes into the fully closed condition. Thus the cap plug 387 and outer tubular member closed bottom 343 simultaneously seal the open top and bottom ends 367 and 363 of the inner tubular member 360 when the straw 300 is in the fully-closed condition. Referring to FIG. 21 , complementary tapers 323 and 389 on the outside wall 325 of the body 310 above the threads 321 and on the inside wall 391 of the cap 380 above the threads 385 are also drawn into abutment with each other to provide a seal between the cap 380 and the body 310 when the straw 300 is in the fully-closed condition. Looking at FIG. 20 , an annular flange 327 is preferably provided on the body 310 below the threads 321 and the cap 380 has a breakaway portion 393 on its bottom end 395 engaged on the flange 327 . The breakaway portion 393 engages on the flange the first time the cap 380 is screwed onto the body 310 . The breakaway portion 393 is separated from the cap 380 the first time the cap 380 is unscrewed from the body 310 to provide “tampering” evidence to a purchaser. The breakaway portion 393 is retained on the straw 300 by the flange after separation. A tether 397 connects the cap 380 to its retained breakaway portion 393 so the cap 380 will always be available to recover the straw 300 . Alternatively, a tear-away wrap (not shown) covering the lower portion of the cap 380 and the upper portion of the body 310 could be used to provide tamper-evident protection. As best seen in FIG. 21 , the seal between the body 310 and the inner tubular member 360 in the fully-closed condition of the straw 300 is assured by complementary tapered surfaces 337 and 399 on a thin upper rim 339 of the body 310 and on the inside wall 391 of the cap 380 . The cap taper 399 co-operates with body rim taper 337 to compress the thin rim 339 of the body 310 against the outer diameter 361 of the inner tubular member 360 to create the seal. The outside wall 325 of the body 310 is adapted for liquid-tight connection to a liquid container fitment 305 with the outer tubular member 340 inside the container and the upper portion 329 of the body 310 outside of the container. For example, and as shown in FIGS. 18-20 , the container fitment 305 has a tapered inside wall with external tabs 303 which engage with corresponding internal circumferential tabs 333 on a complementary snap-type connector 331 on the body 310 to lock the straw 300 to the container. Other configurations of tabs and types of connections between the container fitment 305 and the body connector 331 , such as complementary threads on the fitments, could be used. As shown, complementary tapers 335 and 307 on the body 310 and on the container fitment 305 preferably extend over a substantial portion of the body 310 so as to assure a liquid tight seal between the body 310 and the container fitment 305 . The container fitment 305 may be as hereinbefore described, a part of a top panel of a container, such as by thermo-welding the fitment 305 , to the panel of a collapsible container. Alternatively, the container fitment 305 may be installed as a completion of a container without a top panel, such as by thermo-welding to the inside top portions of the front and back panels of a collapsible container. The lower portion of the body connector 331 can be any size and shape compatible with thermo-welding equipment used for installing fitments into or onto collapsible containers as long as it accommodates a circular opening of the proper size at its center for introduction of liquid into the container. Powdered drink mix, water purification tablets and/or other dry components can be introduced into the container by injection through the passage in the container fitment 305 or into the container directly prior to installing the container fitment 305 . During assembly of the straw 300 , the sections of the outer tubular member 340 formed by the two diametrically opposed longitudinal slots 349 in the outer tubular member 340 should be spread apart enough for insertion of the inner tubular member 360 . Various methods of assembling the straw 300 could be used. By way of example, the sections of the outer tubular member 340 formed by the two diametrically opposed longitudinal slots 349 in the outer tubular member 340 could be positioned and spread apart enough for insertion of the inner tubular member 360 . Also by way of example, the bottom portion of the outer tubular member 340 with the dome-like protrusion 353 could be molded separately from the remaining portion of the outer tubular member 340 and, after insertion of the inner tubular member 360 through the open bottom end of the outer tubular member 340 , connected to the outer tubular member 340 by thermowelding, snap-in or screw-in methods. Also by way of example, the bottom end of the inner tubular member 360 could be flared after insertion into the body 310 and outer tubular member 340 by insertion of a heated flaring tool through one of the slots 349 of the outer tubular member 340 . By way of example, it is anticipated that one operable configuration of the straw 300 for use with a collapsible container would have a polypropylene or high density polyethylene container fitment 305 , an integral polypropylene or high density polyethylene body 310 , an integral extended polypropylene inner tubular member 360 with end flared and outer tubular member 340 and a high density polyethylene or polypropylene cap 380 . The body 310 would be approximately 0.53″ high and have a circumferential shoulder 371 , a neck 373 approximately 0.45″ high, a thin rim 339 with an approximately 0.008″ wall thickness and an inner diameter or passage 311 approximately 0.001″ greater than the inner tubular member outer diameter 361 . The inner tubular member 360 would be approximately 4.3″ long, have an outer diameter 361 of approximately 0.15″ and have approximately 0.008″ wall thickness. Preferably, the inner diameter 357 at the top of the rim 339 will taper to be equal or slightly less than the outer diameter 361 of the inner tubular member 360 , so as to assure a snug engagement of the inner tubular member 360 with the rim 339 . The lengths of the outer tubular member 340 and the inner tubular member 360 are determined only by the desired maximum distance the inner tubular member 360 can be withdrawn from the body 310 . The exemplary outer tubular member 340 would have a length of approximately 2.75″ and a wall thickness of approximately 0.012″. The container fitment 305 would have an approximately 0.5″ diameter passage 309 to accommodate filling. Turning to FIG. 28 , in an alternate embodiment of the body, a body 370 has a generally cylindrical contour for a snug but sliding fit into the inner diameter 372 of the container fitment 374 . The lower part of the body 370 tapers to a narrower diameter cylindrical contour to form an annular gap 378 between the narrower body diameter and the container fitment 374 . An annular flange 375 on the upper rim of the body 370 will engage against the top 376 of the container fitment 374 to limit the depth of insertion of the body 370 into the container fitment 374 . An annular anti-removal ring 377 is provided on the lower rim of the body 370 . At least one, and as shown two, annular sealing rings 379 are provided on the narrower portion of the body 370 above the anti-removal ring 377 . The rings 377 and 379 are flexible. The anti-removal ring 377 has a substantially greater diameter than the inner diameter 372 of the container fitment 374 . The sealing rings 379 have a slightly greater diameter than the inner diameter 372 of the container fitment 374 . When the body 370 is pushed fully into the container fitment 374 , the anti-removal ring 377 releases from the container fitment 374 and expands to its greatest diameter. Using this alternate body 370 , removal of the straw from the container fitment 374 is prevented by the engagement of the upper surface of the anti-removal ring 377 against the bottom surface of the container fitment 374 when a removal attempt is made. The liquid seal is also achieved as the body 370 is pushed fully into the container fitment 374 . The sealing rings 379 flex to make sealing contact against the inner diameter 372 of the container fitment 374 . As seen in FIG. 28 , the sealing rings 379 are positioned on the body 370 so that the seal is maintained whether the body 370 is pushed into the container fitment 374 until the body flange 375 strikes the top 376 of the container fitment 374 or the body 370 is withdrawn from the container fitment 374 until the anti-removal ring 377 strikes the bottom of the container fitment 374 . Thus, it is apparent that there has been provided, in accordance with the invention, a disposable collapsible powdered drink mixing container and telescoping straw that fully satisfy the objects, aims and advantages 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 and in light of the foregoing description. Accordingly, it is intended to embrace all such alternatives, modifications and variations as fall within the spirit of the appended claims.

1a

BACKGROUND OF THE INVENTION [0001] This invention relates generally to the field of diagnostics, and in particular to the diagnosis of cardiovascular conditions. More specifically, the invention relates to systems and methods for stressing a patient's cardiovascular system and then measuring various physiological parameters in order to diagnose the patient's condition. [0002] Cardiovascular ailments, such as high blood pressure, coronary artery disease, and the like pose a significant health threat to millions of individuals. The early and proper diagnosis of such ailments can be beneficial in placing the patient on the road to recovery. Over the years, a variety of techniques have been developed to diagnose such conditions. Some of these techniques involve stressing the patient's cardiovascular system by requiring the patient to physically exercise. For example, one common stress test is to place various monitors on the patient and then require the patient to run on a treadmill. As the patient's system is stressed, parameters such as the patient's blood pressure, heart rate and ECG are measured. These are compared against a set of generally accepted “normal” responses, and abnormal responses are observed based upon the set of “normal” values. [0003] While such tests are generally acceptable, they are cumbersome and inconvenient. For example, they may require the patient to run on a treadmill while being connected to a variety of sensors. Moreover, many patients are not able to exercise, and the exercise itself limits the kinds of physiological data that can be acquired. For instance, various types of measuring equipment are not compatible with a patient running on a treadmill. [0004] Hence, this invention is related to systems and methods for stressing the patient's cardiovascular system in a more convenient and friendly manner. Such systems and methods provide a wide range of advantages as set forth below. BRIEF SUMMARY OF THE INVENTION [0005] The invention provides various systems and methods for diagnosing a cardiovascular-related condition in a breathing person. In one exemplary embodiment, the method proceeds by interfacing a valve system to the person's airway. The valve system is configured to decrease or prevent respiratory gas flow to the person's lungs during at least a portion of an inhalation event. With the valve system coupled to the person, the person is permitted to inhale and exhale through the valve system. During inhalation, the valve system functions to produce a vacuum within the thorax to increase blood flow back to the right heart of the person, thereby increasing blood circulation and blood pressure. Further, at least one physiological parameter is measured while the person inhales and exhales through the valve system. This parameter is evaluated to diagnose a cardiovascular condition. Hence, such a method permits a person's cardiovascular system to be stressed, without having the person physically exercise. [0006] In one aspect, the physiological parameter is measured in a base line state prior to permitting the person to inhale and exhale through the valve system. The measured physiological parameter in the base line state is then compared with the measured physiological parameter following inhaling and exhaling to facilitate diagnosis. Further, such measurements may be compared with normal or expected responses, i.e. with historical data from healthy individuals. [0007] Conveniently, the valve system may be incorporated into a facial mask that is coupled to the person's face. Further, the valve system may include a pressure responsive inflow valve having an actuating pressure in the range from about 0 cm H 2 O to about −50 cm H 2 O. In some cases, the actuating pressure may be increased or decreased over time and the physiological parameter re-measured. Further, the actuating pressure may be increased or decreased based on the previously measured physiological parameter. [0008] In some aspects, the valve system may be further configured to prevent or decrease exhaled gases from exiting the person's lungs during at least a portion of an exhalation. Also, the physiological parameter may be measured following an exhalation. [0009] One particular feature is that the physiological parameter may be measured by an imaging or mapping technique, such as by an ECG, by echo-imaging of the heart, by imaging of radio-labeled markers in the blood, by MRI imaging, by CT imaging, by imaging of markers for cardiac ischemic, and the like. Use of many of these imaging or mapping techniques is possible during the stress test since the person needs only to be coupled to the valve system and is not required to physically exercise during the test. Use of the valve system also permits a wide range of parameters to be measured, such as blood pressure, expired CO 2 , heart rate, air flow and pressure through the airway and lungs, oxygen saturation, blood levels of O 2 , blood lactate, blood pH, tissue lactate, tissue pH, body temperature, and the like. [0010] To enhance the effect of the valve system, one or more substances may be introduced into the person to stress the person's heart. Such substances may be injected into the person's blood stream (such as by use of a needle), may be delivered orally, may be inhaled, or the like. For example, the substance may comprise a volume load of saline solution that is injected into the person's blood stream to stress the person's system. As another example, the substance may comprise nitroglycerine that is injected into the person to lower the person's blood pressure. Other drugs that may be used to stress the heart include adenosine, adrenaline, dobutamine and the like. [0011] In another embodiment, the invention provides an exemplary system for diagnosing a cardiovascular-related condition in a breathing person. The system includes a valve system that is capable of being coupled to the person's airway. The valve system is configured to decrease or prevent respiratory gas flow to the person's lungs during at least a portion of an inhalation event to produce a vacuum within the thorax to in turn increase blood flow back to the right heart of the person. In so doing, blood circulation and blood pressure is increased. The system also includes a monitoring system to monitor changes in at least one physiological parameter while the person inhales and exhales through the valve system. In this way, the person's cardiovascular system may be stressed on monitored simply by coupling the valve system to the person's airway and measuring the parameters. [0012] In one aspect, the monitoring system includes a computer for evaluating the measured parameter to diagnose a cardiovascular condition. Conveniently, at least a portion of the monitoring system may be physically incorporated into the valve system. The monitoring system may also include a controller to change the configuration of the valve system over time to vary the level of inspiratory impedance. For example, the controller may be configured to change the configuration of the valve system based on the measured parameters. [0013] In a further aspect, the valve system may be configured to prevent or decrease exhaled gases from exiting the person's lungs during at least a portion of an exhalation. Further, the valve system may be incorporated into a facial mask that is configured to be coupled to the person's face. The valve system may conveniently include a pressure responsive inflow valve that has an actuating pressure in the range from about 0 cm H 2 O to about −50 cm H 2 O. Such a valve permits gases to flow to the person's lungs during a latter portion of an inhalation event in order to provide sufficient ventilation. [0014] In one particular aspect, the monitoring system may comprise an imaging or mapping system. Examples of systems that may be used include an ECG system, a heart echo-imaging system, a radio-labeled marker imaging system for measuring makers in the blood, an MRI imaging system, a CT imaging system and a cardiac ischemic imaging system. Further, the monitoring system may use a wide range of sensors, such as blood pressure sensors, expired CO 2 sensors, heart rate sensors, air flow and pressure sensors, oxygen saturation sensors, O 2 blood level sensors, blood lactate sensors, blood pH sensors, tissue lactate sensors, tissue pH sensors and body temperature sensors. BRIEF DESCRIPTION OF THE DRAWINGS [0015] [0015]FIG. 1 is a flow chart illustrating one method for diagnosing a cardiovascular-related condition according to the invention. [0016] [0016]FIG. 2 is a perspective view of one embodiment of a facial mask and a valve system that may be used to facilitate a diagnosis according to the invention. [0017] [0017]FIG. 3 is a perspective view of the valve system of FIG. 2. [0018] [0018]FIG. 4 is a cross sectional side view of the valve system of FIG. 3. [0019] [0019]FIG. 5 is an exploded view of the valve system of FIG. 3. [0020] [0020]FIG. 6 is a schematic diagram of a system for diagnosing cardio-vascular-related conditions according to the invention. DETAILED DESCRIPTION OF THE INVENTION [0021] The invention provides various systems and methods to facilitate the measurement of one or more physiological parameters while a person's cardiovascular system is being stressed. The stress tests of the invention may be used when diagnosing a wide range of cardiovascular conditions, such as coronary artery disease, high blood pressure, pulmonary hypertension, cardiac function, severity of peripheral vascular disease, integrity of certain autonomic nervous system reflexes (including the carotid-baro reflex and the vagovagal reflex), intracardiac shunting of blood, and the like. [0022] To stress the cardiovascular system, the invention may utilize some type of inspiratory impedance, at one or more predetermine levels, to increase venous blood flow to the heart, thereby increasing overall circulation and blood pressure. Such a perturbation of the normal physiological system of the body may be assessed by concurrent physiological monitoring. Further, the level of inspiratory impedance, and the way it is altered, may vary. For example, the level of impedance may vary by performing an automatic step-up or step-down of impedance, or it may vary depending upon physiological feedback [0023] To prevent or impede respiratory gases from flowing to the lungs, a variety of impeding or preventing mechanisms may be used, including those described in U.S. Pat. Nos. 5,551,420; 5,692,498; 6,062,219; 5,730,122; 6,155,257; 6,234,916 and 6,224,562, and in U.S. patent application Ser. No. ______, filed on Aug. 19, 2002 (“Systems and Methods for Enhancing Blood Circulation”, Attorney Docket No. 16354-000115), Ser. No. 09/966,945, filed Sep. 28, 2001 and Ser. No. 09/967,029, filed Sep. 28, 2001, the complete disclosures of which are herein incorporated by reference. The resistance to the inflow of respiratory gases may be set between about 0 cm H 2 O and about 50 cm H 2 O and may be variable or fixed as described above. [0024] Because the person's system may be stressed without requiring physical exercise, monitoring of a wide range of physical parameters or conditions may be accomplished in a more convenient manner. For example, monitoring during the stress test may include, but is not limited to, ECG, blood pressure, echo-images of the heart (such as with an ultrasonic transducer or catheter), radio-labeled markers to visualize blood flow, MRI-imaging, CT imaging, measurement of expired CO 2 , heart rate, air flow and pressure through the airway and lungs, oxygen saturation and/or blood levels of O 2 , blood lactate, blood pH, tissue lactate, tissue pH, markers for cardiac ischemic (including tissue and serum creatinine phospho-kinase, serum troponin, serum adenosine—that may all be measured non-invasively or with minimal invasive techniques), temperature, and the like. In some cases, the imaging may need to be gated based upon the respiratory rate, or motion associated with the change in the position of the heart and other body structures (such as when taking MRI or CT images). Further, the valve system permits measurements to be made while the person is standing, sitting or lying down. [0025] Hence, the valve may be configured to decrease intrathoracic pressures relative to both atmosphere pressures and extrathoracic pressures during diagnosis. Its use results in a greater vacuum in the thorax relative to the rest of the body during an inhalation maneuver. This forces more blood back to the chest, thereby increasing blood available for the heart beat. This results in a greater organ perfusion and thus stresses the cardiovascular system in a manner similar to performing exercise. [0026] Conveniently, such valve systems may be incorporated into a facial mask to facilitate coupling of the valve system to the person's airway. Before actuating the valve system, the physiological measures may be made in a baseline state. The valve system may then be actuated or coupled to the airway and measurements taken while the person is breathing through the valve system (which functions to stress the person's cardiovascular system). In some embodiments, the valve system may be connected to or be able to communicate with monitoring systems to record, either directly or remotely from a transmitted signal, a wide variety of diagnostic information. These measurements may be taken before, during and after performing the stress test. The level of inspiratory impedance (plus or minus a small decrease of expiratory impedance) may be varied over a wide range of pressure using designs described in the above referenced patents and applications. [0027] In addition to the use of the valve system, or as an alternative to the valve system, one or more substances may be introduced into the person to stress the person's heart. Hence, in some embodiments, the person's system may be stressed both by the impedance provided by the valve system while breathing and by the substance that is introduced into the patient. These substances may be introduced at one or more times, and using one or more techniques. For example, such substances may be injected into the person's blood stream (such as by use of a needle), may be delivered orally, may be inhaled, or the like. Further, the substances may be introduced before, during and/or after the valve system is coupled to the person. For example, the substance may comprise a volume load of saline solution that is injected into the person's blood stream to stress the person's system. As one example, the volume of saline solution may be in the range from about 500 cc to about 1,000 cc. As another example, the substance may comprise nitroglycerine that is injected into the person to lower the person's blood pressure. Other drugs that may be used to stress the heart include adenosine, adrenaline, dobutamine and the like. [0028] Referring now to FIG. 1, one method for diagnosing cardiovascular-related conditions will be described. As shown in step 10 , baseline physiological parameters may be measured and recorded. The baseline parameters are preferably taken before any stressing of the person's cardiovascular system. These parameters may comprise any of those previously described. Conveniently, these measurements may be stored in a computer and used for later analysis when comparing subsequent measurements. [0029] The method also involves the step of coupling a valve system to the patient's airway as shown in step 12 . This may be performed prior to taking any baseline measurements, provided the valve system is not actuated, or after the baseline measurements have been taken. If before, the valve system may simply be actuated when ready to begin stressing of the person's system. As the person breathes through the valve system, various physiological parameters are measured and recorded as shown in step 14 . While breathing through valve system 200 , the augmentation of pressures within the thorax increases venous blood flow to the hear, to increase overall circulation and blood pressure. As previously described, a substance may also be introduced into the person to increase the amount of stress on the person's system. One advantage of such a method is that measurements may be made using equipment that have typically been incompatible with stress tests. For example, the person may be imaged in a MRI or CT imaging device while breathing through the valve system. Echo images of the heart may also be taken while breathing through the valve system. Further, other measurements may be taken as previously described. [0030] In some cases, it may be desirable to vary the inspiratory impedance level as shown in step 16 . This may be the level of inspiratory impedance, expiratory impedance or both. In such cases, the level of impedance may be varied as illustrated in step 18 , and the process reverts back to step 14 where the parameters are measured with the modified settings. The decision to vary the impedance may be made based on measurements previously recorded. For example, the computer may be programmed to evaluate the measured parameters over time and to send one or more signals to the valve system to change the impedance based on the analysis. Alternatively, the impedance may automatically vary depending on a certain routine. For example, the computer could control an automatic step-up or step-down of impedance. This variance could also be accomplished manually. Techniques for varying the impedance level are described in the previously mentioned patents and patent applications. [0031] Once the appropriate measurements have been taken, the valve system may be decoupled or deactuated as shown in step 20 . Optionally, measurements may also be taken after competition of the stress test as shown in step 22 . With the measurements taken, an analysis of the measured parameters may be made as shown in step 24 . These parameters may be measured against themselves, e.g., the change in blood pressure may be evaluated before, during and after the stress test, and/or against a set of historical data. Such historical data may have expected “normal” responses or ranges of normal responses that are compared against the measured data. If outside of the expected normal ranges, the comparison may be flagged for further consideration. In this way, a variety of cardiovascular conditions or problems may be evaluated in a convenient and more efficient manner. [0032] [0032]FIG. 2 illustrates one embodiment of a facial mask 100 to which is coupled a valve system 200 . Mask 100 is configured to be secured to a patient's face so as to cover the mouth and nose. Mask 100 and valve system 200 are examples of one type of equipment that may be used to stress a person's cardiovascular system. However, it will be appreciated that other valve systems and other coupling arrangements may be used including, for example, those previously referenced. As such the invention is not intended to be limited to the specific valve system and mask described below. [0033] Referring also to FIGS. 3 - 5 , valve system 200 will be described in greater detail. Valve system 200 includes a valve housing 202 with a socket 204 into which a ball 206 of a ventilation tube 208 is received. In this way, ventilation tube 208 may rotate about a horizontal axis and pivot relative to a vertical axis. A respiratory source, such as a ventilation bag, may be coupled to tube 208 to assist in ventilation. Disposed in ventilation tube 208 is a filter 210 that is spaced above a duck bill valve 212 . A diaphragm holder 214 that holds a diaphragm 216 is held within housing 202 . Valve system 200 further includes a patient port 218 that is held in place by a second housing 220 . Housing 220 conveniently includes tabs 222 to facilitate coupling of valve system 200 with facial mask 100 . Also held within housing 220 is a check valve 224 that comprises a spring 224 a , a ring member 224 b , and an o-ring 224 c . Spring 224 a biases ring member 224 b against patient port 218 . Patient port 218 includes bypass openings 226 that are covered by o-ring 224 c of check valve 224 until the pressure in patient port 218 reaches a threshold negative pressure to cause spring 224 a to compress. [0034] When the patient is actively ventilated, respiratory gases are forced through ventilation tube 208 . The gases flow through filter 210 , through duck bill valve 212 , and forces up diaphragm 214 to permit the gases to exit through port 218 . Hence, at any time the patient may be ventilated simply by forcing the respiratory gases through tube 208 . [0035] During the exhalation phase of a breathing cycle, expired gases flow through port 218 and lift up diaphragm 214 . The gases then flow through a passage 227 in ventilation tube 208 where they exit the system through openings 229 (see FIG. 16). [0036] During the inhalation phase of a breathing cycle, valve system 200 prevents respiratory gases from flowing into the lungs until a threshold of negative intrathoracic pressure level is exceeded. When this pressure level is exceeded, check valve 224 is pulled downward as springs 224 a are compressed to permit respiratory gases to flow through openings 226 and to the patient's lungs by initially passing through tube 208 and duck bill valve 212 . Valve 224 may be set to open when the negative intrathoracic pressure is in the range from about 0 cm H2O to about −50 cm H2O, and more preferably from about −5 cm H2O to about −30 cm H2O. Hence, the magnitude and duration of negative intrathoracic pressure may be enhanced during patient inhalation by use of valve system 200 . Once the intrathoracic pressure falls below the threshold, recoil spring 224 a again close check valve 224 . In this way, circulation is increased to cause more blood to flow into the thorax and thereby increase vital organ perfusion. In so doing, the person's cardiovascular system is stressed in a convenient manner. [0037] Any of the valve systems described herein may be incorporated into a diagnostic system 300 as illustrated in FIG. 6. System 300 may conveniently include facial mask 100 and valve system 200 , although any of the valve systems or interfacing mechanisms described herein or the like may be used. Valve system 200 may conveniently be coupled to a controller 310 . In turn, controller 310 may be used to control the impedance level of valve system 200 in a manner similar to any of the embodiments described herein. The level of impedance may be varied based on measurements of physiological parameters, or using a programmed schedule of changes. System 300 may include a wide variety of sensors and/or measuring devices to measure any of the physiological parameters described herein. These sensors or measuring devices may be integrated within or coupled to valve system 200 or facial mask, or may be separate. [0038] For example, valve system 200 may include a pressure transducer for taking pressure measurements (such as the intrathoracic pressures), a flow rate measuring device for measuring the flow rate of air into or out of the lungs, or a CO 2 sensor for measuring expired CO 2 . As another example, system 300 may include an imaging device 320 for taking internal images of the person. Imaging device 320 may comprise a CT scanner, a MRI scanner, or the like. Other examples include equipment for producing echo images of the heart, such as ultrasonic transducers that are used either externally or internally within the heart. With such imaging devices, imaging may need to be gated based upon the respiratory rate, or motion associated with the change in position of the heart and other body structures. This may be accomplished using controller 310 . [0039] The use of valve system 200 permits the use of such imaging equipment because the person's cardiovascular system may be stressed without requiring the person to physically exercise. Instead, the person may sit or lie essentially motionless (except for breathing motion) and be imaged or have other measurements taken. [0040] Examples of other sensors or measuring devices include a heart rate sensor 330 , a blood pressure sensor 340 , and a temperature sensor 350 . These sensors may also be coupled to controller 310 so that measurements may be recorded. Further, it will be appreciated that other types of measuring devices may be used to measure various physiological parameters, such as oxygen saturation and/or blood levels of O 2 , blood lactate, blood pH, tissue lactate, tissue pH and the like. [0041] In some cases, controller 310 may be used to control valve system 200 , to control any sensors or measuring devices, to record measurements, and to perform any comparisons. Alternatively, a set of computers and/or controllers may be used in combination to perform such tasks. This equipment may have appropriate processors, display screens, input and output devices, entry devices, memory or databases, software, and the like needed to operate system 300 . For example, once measurements have been taken and recorded, controller 310 may access a database to obtain information on expected responses. Controller 310 may then perform a comparison to determine any differences and to recommend a possible diagnosis. This information may be stored in a patient record and may also be displayed to a physician and/or printed using a printer. [0042] The invention has now been described in detail for purposes of clarity and understanding. However, it will be appreciated that certain changes and modifications may be practiced within the scope of the appended claims.

1a

FIELD OF THE INVENTION The present invention refers to a closure device for use in joining a pair of surfaces and, more particularly, it is related with a closure device suitable for joining two opposable substrates one of which comprises a plurality of openings and the other one of which comprises a plurality of elongated complementary fasteners. BACKGROUND OF THE INVENTION Methods and devices for fastening two or more objects or two or more parts of said objects to each other are very well known in the prior art. The most popular system of this type is constituted by the so called "Velcro System", which essentially comprises a multiplicity of entangled small fibers arranged on the surface of one of the substrates, and a plurality of hooks arranged on the surface of the opposite substrate, which may be in the form of hooked filaments, loops formed with a hard fiber, clips and the like, arranged in a manner such that, when one of the substrates is pressed against the other, the hooks are trapped within the entangled fibers, thus forming a closure device which will necessitate of a predetermined tensile force to be removed from each other and being highly resistant to shearing forces applied to the assembly. This type of closures, however, are highly degradable after applying such tensile forces repeatedly for a number of times, thus being rendered unsatisfactory after a relatively short use, unless excessively large surfaces are covered with the entangled fibers and the hooks respectively. Consequently, the workers in the art have for long sought a closure system which, being of the same simple construction as the "Velcro System", may be long lasting and non-degradable by the repeated action of engagement and disengagement thereof. Up to the present date, however, no such system has been found. OBJECTS OF THE INVENTION Having in mind the defects of the prior art closure devices, it is an object of the present invention to provide an improved closure device which will be of a simple construction and yet will provide a long lasting resistance to both tensile and shearing stresses. One other object of the present invention is to provide an improved closure device of the above described character, which will provide for a simple locking and unLocking operations without excessive degradation of the two complementary parts, thus permitting a relatively large number of operations. A more particular object of the present invention is to provide an improved closure device of the above described nature, which will provide for a more gentle unLocking operation between a male and a female parts thereof, by rendering the female part capable of being stretched sidewardly to open the cavities wherein the hooks of the male part are trapped. One other object of the present invention is to provide an improved closure device of the above character, which will facilitate manufacture thereof by simple automatic procedures. The foregoing objects and others ancillary thereto are preferably accomplished as follows: According to a preferred embodiment of the invention, an improved closure device is provided which essentially comprises a male part and a female part attached to respective substrates to be joined to each other, said male part comprising a flexible plate and a plurality of elongated hooked-type fasteners attached to said plate and preferably perpendicularly extending therefrom to a predetermined distance, each of said elongated fasteners comprising an end embedded in said plate and an opposite or free end comprising a hooked portion, and said female part comprising a plate provided with a plurality of openings normally having a cross sectional size smaller than the length of the hooked portion of said elongated fasteners so as to permit the forced entrance of said hooked fasteners into said openings to be engaged therin with a force sufficient to prevent the disengagement of said parts under a moderate tensile stress applied to both parts, said openings being however sufficiently elastic to permit the disengagement of said parts under a higher predetermined tensile stress applied thereto. BRIEF SUMMARY OF THE INVENTION The novel features that are considered characteristic of the present invention are set forth with particularity in the appended claims. The invention itself, however, both as to its organization and its method of operation, together with additional objects and advantages thereof, will best be understood from the following description of specific embodiments when read in connection with the accompanying drawings, in which: FIG. 1 is a fragmentary perspective view of a closure device built in accordance with a first embodiment of the present invention, and showing its male and female parts spaced apart in the open position, with said female part being stretched in two perpendicular directions. FIG. 2 is a fragmentary perspective view similar to FIG. 1, but showing the closure device in the closed but unlocked position. FIG. 3 is a view similar to FIG. 2 but showing the closure device in its closed and locked position, with the female part thereof in the released or non-stretched position. FIG. 4 is a fragmentary perspective view of a closure device built in accordance with a second embodiment of the present invention, showing the female part thereof stretched only in one direction. FIG. 5 is a view similar to FIG. 4 but showing the closure device in a closed and locked position, with the female part thereof in the released or non/stretched position. FIG. 8 is a fragmentary perspective view of a closure device built in accordance with a third embodiment of the present invention and showing its male and female parts in the open position. FIG. 7 is a fragmentary perspective view of a closure device built in accordance with a fourth embodiment of the present invention and showing a single composite substrate that is capable of operating both as a male and female part. FIG. 8 is a fragmentary perspective view of a male part of the closure device of the present invention, showing a further embodiment of the elongated fasteners provided on said male part. FIGS. 9 and 10 are fragmentary cross sectional elevational views of still a further embodiment of the closure device of the present invention, showing said device in its open and closed and locked positions, respectively. FIGS. 11 and 12 are fragmentary cross sectional elevational views of still one other embodiment of the closure device or the present invention, showing said device in its open and closed and locked positions, respectively. DETAILED DESCRIPTION Having now more particular reference to the accompanying drawings and more particularly to FIG. 1 thereof, there is shown an improved closure device built in accordance with a first embodiment of the present invention, which comprises two independent substrates generally shown at 1 and 5 in in FIG. 1 of the drawings, each one of said substrates being provided with suitable means to be adhered or fastened to the surfaces of two corresponding opposite parts to be joined by the device of the present invention. Substrate 1 is preferably a substrate provided with at least one but preferably a plurality of openings or perforations 4 which, in the particular instance of the embodiment shown in FIG. 1, are formed between a plurality of weft fibers or cords 2 and a perpendicular plurality of warp fibers or cords 3, said openings 4 being capable of expansion or retraction, depending on a force applied in a sideward direction to the warp and weft fibers outwardly of the center of the corresponding substrate 1, the higher said sideward force, the larger will the openings become. Substrate 5, in turn, includes one or more fasteners such as that shown at 6, said fasteners, in the particular instance of the embodiment of FIG. 1, comprising a rigid stem 7 perpendicularly arranged on the surface of substrate 5 and integrally joined at one of its ends to the surface of said substrate 5, with the other or free end 8 of said stem 7 being formed so as to provide a secure fastening end when entangled with the fibers or cords of substrate 1, such as in the shape of a hook (as illustrated in FIG. 1) or as a harpoon head, arrow head, pin head and the like. The substrate 5 may be of an inelastic nature as shown in FIGS. 1 to 3, or it may also be of an elastic nature as illustrated in connection with FIGS. 4 and 5 for a purpose that will be more clearly explained hereinbelow. When the substrates 1 and 5 are brought together with the hooks confronted with the fibers, said hooks 8 force the fibers 2 and 3 outwardly of the center of the hook and increase the size of openings 4, thus permitting their passage therethrough. When the fastening ends of stems 7 fully pass through the openings 4, the fibers 2 and 3 are released to return to their original position, thus closing the openings 4, whereby the two substrates are firmly fastened. To release the substrates from each other, the fibers or cords 2 and 3 of substrate 1 are manually pulled apart for broadening the openings 4, and the hooks 8 are thusly released to remove substrate 5 from substrate 1. In FIGS. 2 and 3 of the drawings, there is shown the manner in which the closure device of the present invention accomplishes its function, and particularly FIG. 2 shows the perforate substrate 1 subjected to coplanar tensile forces in two perpendicular senses, with the purpose of increasing the area of the openings or spans 4, for permitting, when the two opposite substrates 1 and 5 approach towards each other, the heads 8 of the fasteners 6 to pass through said openings 4, to thereafter, upon complete passage of the heads 8 through the perforate substrate 1, release the coplanar forces so that said openings 4 decrease in size, thus firmly fastening the heads 8 and avoiding disengagement thereof, as shown in more detail in FIG. 3 of the drawings. In order to remove one substrate from the other, the reverse process is effected, that is, the substrate 1 is subjected to coplanar tensile perpendicular forces, the heads 8 of the fasteners 6 are removed from the openings 4, and the forces applied on the substrate 1 are released upon separation of both substrates as described. Of course that the forces that will expand the openings 4, may also be pressure forces, for instance, when the heads of the fasteners 6 have a mechanical resistance sufficient to push by themselves on the edges of openings 4, thereby expanding the same when passing therethrough, said openings returning thereafter to their original position when the heads of the fasteners have completely passed through said openings. In FIGS. 4 and 5 of the drawings, there is shown a fastening procedure which is similar to that already described in connection with FIGS. 2 and 3, but with the variation that the openings or spans 4 of the substrate are subjected to tensile forces along one single direction, for instance, in the particular case of this embodiment, the warp fibers 2 are stretched thus spacing apart the fibers of the weft 3, for permitting the insertion of the hooks 8 of fasteners 6 through the openings 4, whereafter the forces applied on the warp fibers 2 are released, to entangle the hooks 8 of the fasteners 6 in the fibers of the weft, which are approached to each other as shown in FIG. 5. In the particular embodiment of the invention shown in FIGS. 4 and 5, the substrate 5 is shown as an elastic substrate which may at least be stretched in the direction of the arrows shown in FIG. 4, such that, when the fibers 2 are stretched to expand the opening 4, the substrate 5 will also be stretched in order to increase the distance between the fasteners 6 in the same proportion of the expansion of the openings. When the fibers 2 are released, the substrate 5 is also released to contract and maintain the perpendicularity of the fasteners, in the direction of the arrows shown in FIG. 5. It will be obvious to any one skilled in the art that substrate 5 may be stretchable in both perpendicular directions or may be non stretchable as shown in FIG. 3, without departing from the spirit of the present invention. FIG. 6 of the drawings shows another preferred embodiment of the invention, which is a variation in which the perforate substrate indicated by means of reference numeral 21, comprises a plurality of openings 24, said openings having the characteristic that they may be expanded when the heads 28 of the fasteners 26 are introduced therethrough, said heads being, in the instance of this embodiment, in the shape of an arrow head, whereby said heads 28 expand the openings 24 that, after passage of the heads 27 and considering that the material of the substrate 21 is elastic, decrease in size by contraction thereof, thus firmly fastening the heads 28 and preventing disengagement thereof. In the above described embodiments, when it is desired to remove the substrate 5 or 25 provided with the fasteners, from the perforate substrate 1 or 21 respectively, it is necessary to apply a tensile force on the perforate substrate 1 or 21, in the direction of the highest elastic capacity therof or in the direction of the highest capacity of any one of its properties such as elasticity, compressibility, etc., thus performing as some sort of a safety device which prevents disengagement of the substrate provided with the fasteners after the closure operation, and facilitating, however, the disengagement thereof only when the perforate substrate is subjected to the tensile force mentioned above, whereby when the perforate substrate 1 or 21 is subjected to a tensile force for increasing the area of the openings, only a minimum force applied in a perpendicular direction to the surface of the substrates will be necessary to accomplish separation of said substrates. One other desirable characteristic of the material of which the perforate substrate is made, may be the expansibility thereof, which may also be provided artificially on the material in order to expand or reduce the size of the openings, for instance, by varying its temperature, which may be useful for certain particular applications. One other embodiment of the invention is shown in FIG. 7 of the drawings, wherein the closure device in accordance with the invention comprises a substrate 41 provided with openings 44 and also provided with perpendicular fasteners 46 with their respective terminal heads 48, said fasteners being arranged both on the upper surface 50 and on the lower surface 51 of the perforate substrate 41, attached to the solid portions 52 surrounding said openings 44. In this embodiment of the closure built in accordance with the invention, the substrate may be placed over two surfaces or objects which are to be joined, such that it will be supported at the same time on both surfaces or objects, and such that when one of said objects or surfaces is approached to the other, said substrate will be bent over itself, thus joining one portion of said substrate with the remainder thereof. In another application this type of closure device may comprise three perforate substrates, one to be used as an internal substrate and two as external substrates, the internal substrate being built as described and illustrated in FIG. 7 of the drawings, that is, being provided with openings 44 as well as with fasteners 46 on both surfaces thereof, whereas the outer substrates comprise openings 44 as well as fasteners 46 only on one face thereof, preferably on their outer or working surfaces, such that three surfaces or objects may be joined to each other, much in the manner of a sandwiching operation. FIG. 8 of the drawings shows still another embodiment of the substrate provided with the fasteners, which in this particular instance is designated by means of reference numeral 55, and in which the fasteners 56 comprise a straight stem 57 perpendicular to and joined at its lower end to the substrate 55, and provided along its length with two or more branches or locking projections 59 in the form of harpoon heads, as well as a hook 58 at its free end, for use in combined action with the openings of anyone of the perforate substrates described in connection with the prior figures for forming a closure device. Having now reference to FIGS. 9 and 10 of the accompanying drawings, there is shown an additional embodiment of the present invention, similar to the embodiment shown in FIG. 6, except for the fact that in this embodiment the length of the stem 27 shown in FIG. 6, is reduced to obtain a short stem in accordance with the present embodiment, such that said stem has the same length as the thickness of the perforate substrate which is thicker in the case of the present embodiment than in the case of the embodiment of FIG. 6, whereby, as the length of the stem of the fastener coincides with the thickness of the substrate provided with the openings, except for the head of the fastener, said head is locked against the inner surface of said substrate provided with openings. In the embodiment of the invention shown in the above mentioned figures, as it may be clearly seen, the process of fastening is effected by taking advantage of the elastic characteristics of the substrate 65, to which the fasteners 66 are attached, said fasteners 66 consisting of a short straight stem 67 and an arrow head 68, the compressible characteristics of the perforate substrate 61 permitting the entrance of the heads 68 of fasteners 66 through the openings 64, upon expansion thereof due to the triangular form of the arrow heads, and preventing disengagement of the same after said openings return to its original size. Finally, in FIGS. 11 and 12 of the drawings, showing a further embodiment of the invention, together with the process for fastening the two substrates, the fasteners 76 of the substrate 75 each comprises an elongated stem 77 provided along the length thereof with a plurality of bell shaped projections 78, the widest portion of said projections looking towards substrate 75, and the perforate substrate 71 having a thickness coincident with the length of the stem 77 of the fastener 76, such that the openings 74 are expanded due to the conical shape of the projections 78 provided on said stem, or due to the application of a tensile force along anyone of the directions of substrate 71, to permit the passage of the stem 77 and its projections 78, which will be pressed between the walls of the openings 74 when the tensile forces are released, or when the fastener ceases to push inwardly of the openings, as clearly shown in FIG. 12 of the drawings. A variety of combinations may be made with the different embodiments of perforate substrate and fastening substrate of the present invention, and it may be seen that for the first time, a closure device having the remarkable properties of being easily closeable and at the same time of remaining securely locked upon closure thereof and yet easily openable by a very simple operation, has been provided, which essentially comprises two or more substrates, at least one of which is provided with expandable openings and at least one other of which is provided with perpendicular elongated fasteners, constituted by a stem having a head at its free end or provided along the length thereof with a plurality of projections similar to the head or different in shape with respect to the head, wherein the free areas of the openings may vary in size either by the pushing force exercised by the heads of the fasteners of the fastening substrate, or when applying a tensile force to the substrate provided with openings, in one or more directions, with the purpose of permitting the introduction of the heads of the fasteners through said openings, which thereafter are contracted when the heads of the fasteners have completely passed through the openings, or when the tensile force ceases to be applied, such that the disengagement of the fasteners from the openings of the substrate will be prevented, thus generating a permanent joint, until the area of said openings is again increased in order to release the fastening devices by the application of a tensile force in one or more directions of the perforate substrate. On the other hand, the operation of the closure device of the present invention is fast, simple and of practical operation, as it will be evident to anyone skilled in the art, and it must be understood that the illustrative embodiments shown in the accompanying drawings are only of an exemplifying character and do not limit the scope of the invention, inasmuch as the closure device of this invention may be subject to many different variations in the details thereof, for instance, by making the head of the fasteners in a different suitable form, with the only condition that said head must be able to be locked within the openings, and said openings may also have any different suitable shape in order to permit the passage of the fasteners, but not the extraction thereof, except after the application of the above described tensile forces. On the other hand, the material for manufacturing the closure device may be any material having suitable physical characteristics, and may be built by means of a net formed by warp and weft fibers, or may also be built as a solid surface having openings therein, or the stems of the fasteners of the substrate may have a head or said head plus two or more projections along the length thereof, or may be deprived of the head itself and may be only one or more projections along the length of the stem, and the like, all of these variations being intended to fall within the true scope and spirit of the present invention. Although certain specific embodiments of the present invention have been shown and described above, it is to be understood that many modifications thereof are possible. the present invention, therefore, is not to be restricted except insofar as is necessitated by the prior art and by the spirit of the appended claims.

1a

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims benefit of Provisional Application No. 60/655,822, filed on Feb. 24, 2005, entitled “Oven Grill Pan with Adjusting Hinge,” the entire disclosure of which is incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates generally to the field of grilling instruments, and, more particularly, to a two-part grill pan with an adjustable hinge for grilling foods inside of a conventional oven or a convection oven. [0004] 2. Related Art [0005] Apparatuses for grilling food are well known and commercially available. Prior art includes grilling devices for use atop a conventional gas or electric range, as well as the famous George Foreman™ grill. Drawbacks of such devices include a dependency on an attached power source or heating element, difficulty in cleaning the device, and typically a small size, which limits the amount of food that may be cooked at one time on the cooking space. SUMMARY OF INVENTION [0006] The present invention comprises a two-part grill pan for grilling foods of different thicknesses inside a conventional or convection oven. In an embodiment of the present invention, a grill pan is implemented as a formed heat-conducting metal rectangular base or lower portion supporting a food cooking, or grilling, surface and a formed heat-conducting metal rectangular lid or upper portion to be placed on top of food to be cooked. Preferably, the positions of the base and the lid relative to each other are set by adjustable hinge-like mating portions. The mating portions allow a vertical distance between the base and the lid to be freely adjustable to accommodate foods of various thicknesses. The mating portions prevent the base and the lid from shifting laterally relative to each other [0007] According to one aspect of the present invention, the base comprises an upper portion and a lower portion, where the upper portion is a corrugated grill surface with a plurality of elevated grill ridges, referred to herein as “veins,” disposed at a distance from one another, and grooves, referred to herein as “drain channels,” alternately positioned between the grill veins, which allow grease, juice, and/or other food liquids to drain from the food being grilled. A wall is positioned about the periphery of the base and may be upstanding such that the wall extends above the grill veins of the base. In a preferred embodiment, a front portion of the wall of the base is tall enough to meet a top surface of the lid when the lid lays on the base for storage. [0008] According to another aspect of the present invention, a collecting channel, or grease channel, runs along a lower internal section of the front portion of the wall of the base, and is in fluid communication with the drain channels. In some embodiments, the collecting channel runs along a peripheral edge of the base. The collecting channel has a top edge lower than the top of the front portion of the wall of the base. Advantageously, the grill veins of the base are positioned at a slight downward slope, from a higher elevation at a back portion of the wall of the base to a lower elevation at the front portion of the wall of the base, in order to facilitate the flow of grease, juice, and/or other food liquids from the drain channels into the collecting channel. The collected grease, juice, and/or other food liquids subsequently may be poured readily from the grill pan. [0009] In yet another aspect, the base of the grill pan includes one or more indentations in a portion of the wall. The indentations may extend through the width of the portion of the wall and, advantageously, may be located just above the top edge of the collecting channel inside the front portion of the wall. These indentations allow for one or more lift handles to be hooked onto the upper edge of the collecting channel, which allows a user to lift and move the grill pan without physically touching the grill pan, such as, for example, when the grill pan is placed into or removed from an oven. Advantageously, the lift handles may be made of any sturdy, heat-resistant material including, for example, metal encased in a wooden grip. The lift handles may be fixed to the base of the grill pan or they may be removable. [0010] According to another aspect of the present invention, the lid of the grill pan includes an upper surface and a lower surface, where the lower surface is a corrugated surface with a plurality of grill veins similar to those of the base and disposed at a distance from one another, and with a plurality of drain channels alternately positioned between the grill veins of the lid. The grill veins of the lid extend from a back edge of the lid to a front lip at a front edge of the lid. In a preferred embodiment, the lid is dimensioned smaller than the base such that it may rest within the periphery of the base for storing purposes. Preferably, the lid includes a lid handle, or lid lift lug, positioned at the front lip of the lid. Optionally, the lid handle may be centered along the front lip of the lid or may be in two or more parts positioned in a spaced relationship along the front lip of the lid. The lid handle allows a user to easily lift and lower the lid of the grill pan, either by hand or by one or more of the lift handles. The lid handle may be integrally formed from the material as the lid of the grill pan, or it may be a separate unit that is physically attached to the grill pan lid. Optionally, the lid handle may include an aperture for hooking a lift handle in order to lift the lid to an opened position relative to the base. [0011] In yet another aspect, the lid has indentations in the front lip, and spaced such that the lid indentations line up with the indentations in the base of the grill pan. The lid indentations provide clearance for the lift handles to properly hook onto the top edge of the collecting channel in order to lift and move the grill pan while the lid is resting within the periphery of the base. [0012] In a further aspect of the present invention, the lid of the grill pan is pivotally registered to the base by an adjusting hinge. The adjusting hinge comprises a plurality of lid pivot guide pins, which include outer guide pins that protrude upwards from the back portion of the wall of the base, and inner guide pins that protrude from the upper surface of the base, from a position near a back portion of the wall of the base. The lid pivot guide pins may be positioned substantially perpendicular to the upper surface of the base. Optionally, other configurations of lid pivot guide pins that allow the lid to be pivotally registered to the base are within the scope of the present invention. Positioned along a portion of the wall of the base is a lid stop that allows the lid to rest in an opened position generally upright or perpendicular to the base of the grill pan, while also preventing the lid from falling backwards. Preferably, the lid stop protrudes substantially upward from the back portion of the wall of the base. The lid pivot guide pins and the lid stop may be integrally formed from the same material as the base of the grill pan, or they may be separate units that are welded or attached by other means to the back portion of the wall of the base of the grill pan. Optionally, other configurations of lid pivot guide pins that allow the lid to be pivotally registered to the base are within the scope of the present invention. [0013] In still another aspect of the present embodiment, a portion of the back edge of the lid may be machined smooth into a cylindrical bar portion. At the ends of bar portion, a small portion of the lid is carved out along a short length of the grill veins, producing two slots. To connect the lid to the base, the bar portion slides between the lid pivot guide pins and the two slots fit around the inner guide pins, allowing the lid to lay flat onto the base or within the periphery of the base. The lid pivot pins protrude from the ends of the bar portion of the lid and align the base with the lid. The lid pivot pins also provide stability to the lid when pivotally registered to the base. By not permanently affixing the lid to the base, the lid may adjust freely to the height or thickness of foods placed between the lid and the base, so that the lid lays generally flat on top of foods placed inside the grill pan. Additionally, the lid may be separated completely from the base for cleaning purposes. Accordingly, other configurations of an adjusting hinge are within the scope of the present invention. [0014] Alternatively, the bar portion and lid pivot pins may be integrally formed out of the same material as the lid of the grill pan, or they each may be separate units that are welded or attached by other means to the back edge of the lid of the grill pan. [0015] According to another aspect of the present invention, the grill pan may be made of an uncoated metal in order to produce grill marks on foods placed inside the grill pan. Preferably, the grill pan is made of aluminum, steel, or any other metal of sufficient weight and consistency to provide proper heat conduction. Advantageously, the grill veins and valleys of both the lid and the base may be triangular in shape. However, one of ordinary skill would recognize that other embodiments of the present invention may incorporate grill veins of other functional shapes, such as, for example, rectangular, semi-cylindrical, and trapezoidal. [0016] According to an embodiment of the present invention, a method for grilling foods using the grill pan includes placing food onto the grill veins of the base and lowering the pan lid to rest on the food such that the grill veins of the pan lid rest against the food. The lid adjusts to the thickness of the food via the adjusting hinge and lays flat on top of he food. A user may hook the lift handles onto the collecting channel inside the base of the grill pan, and pick up and place the grill pan inside a conventional oven or, in the alternative, a convection oven, without having to physically touch the grill pan and risk dropping the pan or being burned. The grill pan grills food thoroughly, and, most likely, in an amount of time less than what it would take to cook the food in a conventional oven or a convection oven without using the grill pan. Additionally, the grill pan places grill marks onto the food. Advantageously, the grill pan may prevent food cooked therein from drying out, which is a common drawback of baking or broiling food inside a conventional oven or a convection oven. Once fully cooked, or grilled, the user again may use the lift handles to remove the grill pan from the oven and may use one lift handle to open the lid of the grill pan. Thus, a grilling instrument for use inside a conventional oven or a convection oven is provided. Accordingly, the grilling instrument of the present invention also may be used atop a common barbeque pit, inside a brick-oven, or in conjunction with any other type of indoor or outdoor cooking apparatus. BRIEF DESCRIPTION OF THE DRAWINGS [0017] The present invention will be more readily understood from the detailed description of the preferred embodiment(s) presented below considered in conjunction with the attached drawings, of which: [0018] FIG. 1 presents a rear perspective view of a grill pan in a semi-opened position, according to an embodiment of the present invention; [0019] FIG. 2 presents an exploded perspective view of components of a grill pan and a side view of a grill pan, according to an embodiment of the present invention; and [0020] FIGS. 3A and 3B are rear perspective and front perspective views of a grill pan in an opened position, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0021] FIG. 1 is discussed in conjunction with FIG. 2 . FIG. 1 is a rear perspective view of a grill pan 100 with a base 102 and a lid 101 pivotally registered to the base 102 by an adjusting hinge 115 . FIG. 2 presents an exploded perspective view of individual components that make up a grill pan 100 according to an embodiment of the present invention. A base 102 supports a corrugated food cooking surface with grill rods 103 a , or grill veins, disposed at a distance from one another, and drain channels 103 b , or valleys, alternately positioned between the base grill veins 103 a . Similarly, a lid 101 has grill veins 104 a disposed at a distance from one another, and channels or valleys 104 b alternately positioned between the lid grill veins 104 a . Preferably, the lid grill veins 104 a are sized and spaced apart such that the lid grill veins 104 a rest in an interlocking position with the base grill veins 103 a when the lid 101 is placed in a closing position onto the base 102 for nonuse or storing purposes. [0022] In FIGS. 1 and 2 , an upstanding wall 105 surrounds the periphery of the base 102 and, advantageously, is of a height greater than the height of the base grill veins 103 a . Two side portions 105 b of the wall 105 and a back portion 105 a of the wall 105 of the base 102 are adjacent to the grill Veins 103 a . A front portion 105 c of the wall 105 , however, is spaced at a distance from the front edges of the grill veins 103 a . Within this space is a collecting channel, or grease channel 106 , which runs transverse to the base grill veins 103 a . The collecting channel 106 provides for collecting grease, juice, and other food liquids, which are produced during a grilling process. As shown in the side section view, in FIG. 2 , the base grill veins 103 a are positioned at a slight downward slope 107 , from a higher elevation at the back portion 105 a of the wall 105 of the base 102 to a lower elevation at the front portion 105 c of the wall 105 of the base 102 , in order to facilitate the flow of food liquids for easy disposal. Grease, juice, and other food liquids may run along the sides of the base grill veins 103 a and temporarily collect in the drain channels 103 b alternately positioned between the base grill veins 103 a . The downward slope 107 of the base grill veins 103 a then provides for a natural flow of the grease, juice, and other food liquids into the collecting channel 106 , where it keeps until the grill pan 100 is removed from a conventional oven, or a convection oven. Although FIGS. 1-5 present a rectangular base 102 and a rectangular lid 101 , the grill pan 100 of the present invention may have other shapes, including circular, oval, and polygonal shapes. [0023] As shown in FIG. 2 , the collecting channel 106 has a top edge 108 , which is lower than the top edge of the front portion 105 c of the wall 105 of the base 102 . Two indents 109 are positioned on the front portion 105 c of the wall 105 of the base 102 , above the upper edge 108 of the collecting channel 106 . The indents 109 extend through the width of the front portion 105 c of the wall 105 and allow for lift handles 110 to be hooked onto the upper edge 108 of the collecting channel 106 , allowing a user to lift and move the grill pan 100 without physically touching the grill pan 100 , which may be heated to oven temperatures. Thus, a user may use the grill pan 100 safely without the worry of being burned and/or spilling food liquids from the grill pan 100 , which may be messy and dangerously hot. [0024] Preferably, the lift handles 110 are made of a material that is able to withstand high temperatures, able to bear a heavy weight load, and is a poor heat conductor. For example, the lift handles 110 made be made of metal encased in wood or any other material capable of withstanding high temperatures and preventing heat conduction. According to a preferred embodiment, a portion of the lift handle 110 used to hook onto a grill pan 100 may comprise two metal prongs, formed generally parallel to one another and shaped such that the prongs provide a secure fit onto the grill pan 100 . The two prongs may be machined in a bent or angled position with respect to the remaining portion of the lift handle 110 , as shown in FIG. 2 , however, one of ordinary skill would recognize that the lift handles 110 of the present invention may be formed into multiple configurations and still perform their necessary function. [0025] A lid 101 of the grill pan 100 includes grill veins 104 a similar to the base grill veins 103 a and disposed at a distance from one another, with channels 104 b alternately positioned between each grill vein 104 a . The lid grill veins 104 a extend from a back edge 111 a of the lid 101 to a front lip at a front edge 111 b of the lid 101 . The front lip provides a surface area for a lid lift lug 112 , or lid handle, and two indents 113 or grooves, which serve as clearance grooves for the lift handles 110 . The lid handle 112 may be positioned in the center of the front lip of the lid 101 , as shown in FIG. 2 , and may be integrally formed from the same material as the lid 101 of the grill pan 100 , or it may be a separate attachment. Optionally, the lid handle 112 may have an aperture 114 for hooking the lift handle 110 onto the lid handle 112 in order to lift the lid 101 to an opened position relative to the base 102 . [0026] As shown in FIGS. 1 and 2 , the clearance grooves 113 in the front lip of the lid 101 are positioned such that the clearance grooves 113 line up with the indents 109 in the front portion 105 c of the wall 105 of the base 102 . The clearance grooves 113 prevent the lid 101 from inhibiting the lift handles 110 ability to hook onto the top edge 108 of the collecting channel 108 when the lid 101 is in a closed or flat position, relative to the base 102 . [0027] The lid 101 of the grill pan 100 is pivotally registered to the base 102 via an 115 adjusting hinge, as shown in FIGS. 1 and 3 A- 3 B, where FIGS. 3A and 3B . In a preferred embodiment, the adjusting hinge 115 includes a plurality of lid pivot guide pins 116 , as shown in FIGS. 1 and 2 , which protrude upwards from the back portion 105 a of the wall 105 of the base 102 and from a location inside the base 102 , where the location is disposed at a distance from the back portion 105 a of the wall 105 of the base 102 . The plurality of lid pivot guide pins 116 , as shown in FIG. 2 , may be separate units that are attached to the base 102 , or may be integrally formed from the same material as the base 102 . The plurality of lid pivot guide pins 116 may include outer lid pivot guide pins, which are located along the back portion 105 a of the wall 105 of the base 102 , and inner lid pivot guide pins, which are positioned at a relatively short distance from the outer lid pivot guide pins, as shown in FIG. 2 . The lid pivot guide pins 116 may be positioned generally perpendicular to the base grill veins 103 a , as shown in FIGS. 1 and 2 . Alternately, other configurations of lid pivot guide pins 116 that allow the lid 101 to be pivotally registered to the base 102 are within the scope of the present invention. [0028] As shown in FIGS. 1 and 2 , a lid stop 117 is positioned between the two outer lid pivot guide pins 116 , and protrudes generally upward from the back portion 105 a of the wall 105 of the base 102 and generally perpendicular to the grilling surface. The lid stop 117 permits the lid 101 to rest in an opened position generally upright or perpendicular to the base 102 of the grill pan 100 , and also prevents the lid 101 from falling backwards when in the opened position. [0029] As shown in FIGS. 1 and 2 , a portion of the back edge of the lid 101 is formed into a smooth cylindrical edge, or bar portion 118 , and when the lid 101 is registered to the base 102 , the bar portion 118 is positioned between the lid pivot guide pins 116 of the base 102 , such that it “slides” between the lid pivot guide pins 116 . Adjacent to the bar portion 118 is one or more hinge slots 119 carved into the lid 101 of the grill pan 100 , and are positioned generally parallel to the lid grill veins 104 a and generally perpendicular to the bar portion 118 . The bar portion 118 and the hinge slots 119 register the lid 101 to the base 102 with the bar portion 118 sliding between the outer and inner lid pivot guide pins 116 while the hinge slots 119 fit around the lid pivot guide pins 116 . To align the base 101 with the lid 102 , a lid pivot pin or bolt 120 may be attached to each outer end of the bar portion 118 of the lid 101 such that the lid pivot bolts 120 extend beyond the total length of the back portion of the wall 105 of the base 102 from one outer lid pivot guide pin 116 to the other outer lid pivot guide pin 116 . Alternately, the lid pivot bolts 120 may be integrally formed from the same material as the lid 101 instead of being separate units for attachment. [0030] The adjusting hinge 115 allows the lid to move freely with respect to the base of the grill pan 100 . When food is placed onto the grill surface of the base 102 , the lid 101 adjusts to the height or thickness of the food and may lie generally flat on top of the food instead of at an angle. With the lid 101 lying generally flat, the grill pan 100 is easily placed into a conventional oven or a convection oven. Additionally, a greater surface area of the lid 101 comes into contact with the food. Advantageously, the lid 101 may be separated completely from the base 102 in order to be cleaned. [0031] FIG. 3A is a rear perspective view of a grill pan 100 , according to an embodiment of the present invention, with a lid 101 of the grill pan 100 placed in an opened position. As shown in both FIGS. 3A and 3B , the lid 101 is pivotally registered to a base 102 of the grill pan 100 by an adjusting hinge 115 with a bar portion resting 118 between a plurality of lid pivot guide pins 116 , similar to FIG. 1 . The lid 101 rests against a lid stop 117 , which permits the lid to rest in an open position generally perpendicular to the base 102 . FIG. 3B is a front perspective view of the same grill pan 100 . [0032] FIG. 3 is a perspective view of a grill pan, according to an embodiment of the present invention, in a closed position while not in use. In this embodiment, a lid stop runs a length of a back portion of the wall portion between two lid pivot guide pins, and both the lid stop and the lid pivot guide pins are integrally formed from the same material as the base of the grill pan. Additionally, slots carved into the lid are shown in greater detail. [0033] As will be appreciated, there are countless configurations for a grill pan that grills foods inside a conventional or convection oven. FIGS. 1-7 illustrate only a few possible configurations, and in no way should be construed as limiting the application of the inventive apparatus to those configurations. To the contrary, the invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

1a

CROSS REFERENCE TO RELATED APPLICATIONS The present application is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2011/067499 filed Oct. 6, 2011, which claims priority to European Patent Application No. 10187002.0 filed Oct. 8, 2010 and U.S. Provisional Patent Application No. 61/432,258 filed Jan. 13, 2011. The entire disclosure contents of these applications are herewith incorporated by reference into the present application. FIELD OF INVENTION The invention relates to a reusable engine for an auto-injector for administering a dose of a liquid medicament according to the preamble of claim 1 . BACKGROUND Administering an injection is a process which presents a number of risks and challenges for users and healthcare professionals, both mental and physical. Injection devices (i.e. devices capable of delivering medicaments from a medication container) typically fall into two categories—manual devices and auto-injectors. 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. 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. 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. 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. 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. SUMMARY It is an object of the present invention to provide a novel reusable engine for an auto-injector. The object is achieved by an engine for an auto-injector according to claim 1 . Preferred embodiments of the invention are given in the dependent claims. 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. According to the invention an engine for an auto-injector for administering a dose of a liquid medicament comprises a case having a distal end and a proximal end arranged to be attached to a packaged syringe. The packaged syringe contains a syringe with a hollow needle and a stopper for sealing the syringe and displacing the medicament. The syringe is slidably arranged with respect to the case. The case of the engine contains: drive means capable of, upon activation: pushing the needle from a covered position into an exposed position, and operating the syringe to supply the dose of medicament, and activating means arranged to lock the drive means in a loaded state prior to manual operation and capable of, upon manual operation, releasing the drive means for injection. According to the invention the drive means is arranged as a gas spring comprising a cylinder and a piston with a plunger for transmitting the spring force. A compressed gas is provided in a high pressure cavity defined between the piston and a distal end of the cylinder. The cylinder is slidably arranged in the case but may be prevented from translation by a latch arranged to lock the cylinder to the case. The latch is disengageable by the released drive means being at least nearly fully extended in a manner to allow the cylinder and thus the whole extended gas spring to be translated in distal direction, e.g. into a clearance provided in the distal end of the case. The drive means, i.e. the gas spring is nearly fully extended at the end of an injection stroke when the medicament has been at least nearly entirely injected into an injection site, e.g. a patient's skin. When the user removes the auto-injector from the injection site it is desirable to hide the needle in order to prevent needle stick injuries. One way to achieve needle safety is to retract the needle into a case or sleeve. Disengaging the cylinder from the case allows the plunger to be moved in distal direction so it does no longer push against the stopper thus allowing the syringe and the needle to be retracted. The advantage of using a gas spring is that it allows for smaller and more compact engines than conventional compression spring engines. Furthermore a gas spring may be designed with inherent damping so shock loads onto the syringe and stopper may be avoided. A gas spring also has the advantage of less change in force as it expands, compared to a normal compression spring. This means less change in injection rate throughout the dose. Preferably a cylinder spring may be arranged in the case for biasing the cylinder against the case in distal direction. This allows for actively translating the cylinder in distal direction as soon as the latch has been disengaged. Another mechanism in the packaged syringe, for retracting the syringe and needle in the packaged syringe e.g. a syringe spring can therefore be dimensioned to do just that without having to translate the gas spring. The compressed gas used in the gas spring may be Nitrogen. Other gases, such as carbon dioxide may also be applied. The compressed gas may exhibit a pressure of approximately 10 bar when the gas spring is in the loaded state. The gas may also have another pressure remarkably greater than the atmospheric pressure. In a preferred embodiment the activation means may be arranged as a trigger button laterally arranged at the case. The trigger button may have a dog for engaging the plunger prior to manual operation in a manner to prevent translation of the plunger. The dog is arranged to disengage from the plunger upon manual operation so the plunger may translate in proximal direction forced by the expanding gas. In an alternative embodiment the trigger button may be arranged at the distal end of the engine, the opposite end to where the needle appears. However, this increases the risk of operating the auto-injector in the wrong direction and subsequent injury by inserting the needle into the user's thumb. Application of a lateral or side button helps to eliminate that risk. The dog may be shaped as a loop with an aperture for the plunger. The aperture comprises a narrow portion aligned with the plunger prior to manual operation of the trigger button and a wide portion aligned with the plunger upon manual operation, i.e. pushing the trigger button radially inwards with respect to a longitudinal axis of the engine. The plunger has a main section adjacent to the piston and a locking section proximally from the main section. When the gas spring is in the loaded state the main section is essentially hidden in the cylinder while the locking section is outside the cylinder. The narrow portion of the aperture has a diameter smaller than a diameter of the main section but wider than a diameter of the locking section thus allowing to hold the locking section while preventing the main section from passing through prior to manual operation of the trigger button. The wide portion of the aperture has a diameter at least as wide as the diameter of the main section in order to allow it to pass through when the trigger button has been pressed. Syringe retraction is ideally triggered when the syringe has been emptied. Due to tolerances in manufacturing of the syringe and other components the exact position of the stopper in relation to the syringe in this situation can differ between different syringes. This may lead to situations where retraction is triggered before the stopper has bottomed out so the syringe is not fully emptied. In other cases the stopper may bottom out before refraction is triggered resulting in the auto-injector stalling and not retracting the syringe at all. In order to solve both problems, reliably triggering retraction and emptying the syringe, the plunger may be telescoped with a plunger front part, wherein a plunger spring biases the plunger front part against the plunger rear part. The plunger may comprise a shoulder beyond the locking section in proximal direction. The shoulder is followed by a pin, wherein the shoulder has a greater diameter than the pin. The plunger front part is telescoped with the pin. The plunger spring is arranged on the pin in a manner to bias the plunger front against the shoulder. Alternatively, the pin may be arranged at the plunger front part telescoped with a corresponding bore in the plunger. The plunger spring is defined to generate a force greater than the hydraulic force of the emptying the syringe yet weaker than the force of the gas spring. This allows for pushing the stopper until it bottoms out in the syringe so the syringe is emptied. The gas spring continues pushing the plunger in proximal direction thus partially compressing the plunger spring. The retraction is then triggered as soon as the gas spring is expanded so far as to disengage the latch. Thus both problems are solved, reliably retracting the hollow needle to a safe position and fully emptying the syringe which is particularly desirable with expensive drugs. Emptying the syringe is also important for dosage accuracy. In a preferred embodiment a button latch may be arranged in the case, the button latch slidable between a locking position obstructing the trigger button in a manner to prevent it from being pressed and an unlocked position, where the trigger button is allowed to be pressed inwardly. Inadvertently triggering an injection is thus less likely since the button latch has to be operated before the trigger button can be pressed. The button latch may be arranged to be pushed into the unlocked position by a transfer sleeve arranged in the packaged syringe when a proximal end of the transfer sleeve is pushed against an injection site. The user is thus required to observe a sequence of operation. First, the auto-injector has to be pressed against the injection site. Then the trigger button may be pressed to start the injection. A valve may be arranged in the cylinder in a manner to restrict venting of a low pressure side of the piston opposite the high pressure cavity. This may be used to specify the damping characteristics of the gas spring so a speed of insertion and injection may be controlled. Preferably, the valve is defined to ensure a damping rate greater than a damping force generated due to friction between the stopper and an inner wall of the syringe and due to hydraulic resistance of the liquid medicament forced through the hollow needle by the advancing stopper. Since the force on the piston from the compressed gas is always distributed between the damping force of the valve and any load applied to the proximal end of the plunger, the syringe and needle may be advanced in a manner avoiding or minimizing wet injection, i.e. i.e. the liquid medicament is not leaking out of the hollow needle before or during needle insertion. The reusable engine is preferably used in an auto-injector for administering a dose of a liquid medicament, the auto-injector comprising the engine and the packaged syringe. The syringe is at least partially arranged inside a tubular syringe retainer arranged for connecting the packaged syringe to the engine and for restricting longitudinal motion of the syringe. The syringe and the needle are arranged to be hidden inside the packaged syringe when the drive means is in its loaded state. The syringe is biased in distal direction by a syringe spring and movable in proximal direction by the drive means of the engine into a position with the needle protruding beyond a proximal end of the packaged syringe. The syringe spring serves for retracting the syringe and the needle after the end of the injection provided the plunger has stopped pushing against the stopper and can be translated in distal direction or is actively pulled in distal direction. A tubular transfer sleeve may be arranged around the syringe in a manner to hide the syringe and the needle when the drive means is in its loaded state. The transfer sleeve is preferably movable in distal direction by a small distance and biased in proximal direction by at least one resilient member. The transfer sleeve extends through the syringe retainer in a manner to engage the button latch of the engine thus providing skin interlock functionality, i.e. the trigger button is prevented from being pressed as long as the transfer sleeve is not translated back by pushing it against the injection site. A removable cap may be arranged on the packaged syringe for protecting the syringe during shipping and handling and for protecting the user when the packaged syringe is being attached to the engine. Usually the hollow needle is equipped with a protective needle sheath for keeping the needle sterile and preventing it from being mechanically damaged. The protective needle sheath is attached to the needle when the syringe is assembled. The cap may be arranged to grip the protective needle sheath. When the cap is removed from the housing in preparation of an injection the protective needle sheath is reliably removed without exposing the user to too high a risk to injure themselves. 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 syringe may consist of any rigid material, such as glass or plastics. Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. BRIEF DESCRIPTION OF THE DRAWINGS The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, and thus, are not limitive of the present invention, and wherein: FIG. 1A , and FIG. 1B shows two longitudinal sections of an auto-injector with a gas spring in two different section planes, FIG. 2 is a longitudinal section of the auto-injector after removal of a cap and a protective needle sheath, FIG. 3 is an isometric view of the auto-injector, FIG. 4 is an isometric view of the interior of the auto-injector, FIG. 5 is another isometric view of the interior of the auto-injector, and FIG. 6 is a longitudinal section of a reusable engine. Corresponding parts are marked with the same reference symbols in all figures. DETAILED DESCRIPTION FIG. 1 shows an auto-injector 1 . The auto-injector 1 comprises a reusable engine 1 . 1 and a disposable packaged syringe 1 . 2 . The disposable packaged syringe 1 . 2 comprises a cap 2 , a syringe 3 with a hollow injection needle 4 and a stopper 5 for sealing the syringe 3 and displacing a liquid medicament M. The syringe 3 is arranged inside a support sleeve 6 which in turn is arranged inside a tubular transfer sleeve 7 which may be translated within a tubular syringe retainer 8 . The syringe retainer 8 is arranged to restrict longitudinal translation of the syringe 3 . The reusable engine 1 . 1 comprises a case 9 with an open proximal end. A gas spring 10 is arranged in the case 9 , the gas spring 10 comprising a cylinder 10 . 1 with a closed distal end and a piston 10 . 2 arranged to reciprocate in the cylinder 10 . 1 and seal against the cylinder walls. A high pressure cavity filled with a compressed gas G is defined between the distal end of the cylinder 10 . 1 and the piston 10 . 2 . The gas G may be Nitrogen at a pressure of approximately 10 bar when the gas spring 10 is in a loaded or compressed state. The piston 10 . 2 is arranged at a distal end of a plunger 10 . 3 . The cylinder 10 . 1 may be translated in longitudinal direction in the case 9 . A latch 14 is provided for preventing this longitudinal motion by locking the cylinder 10 . 1 to the case 9 . A flexible diaphragm (not illustrated) may be arranged in the cylinder 10 . 1 under the latch 14 for sealing the cylinder 10 . 1 . A cylinder spring 15 , arranged between an internal shoulder 9 . 1 in the case 9 and an external shoulder 10 . 4 at the cylinder biases the cylinder 10 . 1 in distal direction D with respect to the case 9 . The cylinder spring 15 is compressed in an initial state of the auto-injector 1 . The plunger 10 . 3 extends in proximal direction P in a manner to allow it to push against the stopper 5 of the syringe 3 when the packaged syringe 1 . 2 is attached to the reusable engine 1 . 1 . A trigger button 11 is arranged in a lateral aperture in the case 9 . Inside the case 9 a button latch 12 is slidably arranged. It may be slid between a locking position obstructing the trigger button 11 in a manner to prevent it from being pressed and an unlocked position allowing the trigger button 11 to be pressed inwardly. The trigger button 11 has a dog 11 . 1 arranged inwardly. The dog 11 . 1 has as an aperture for the plunger 10 . 3 , the aperture comprising a narrow portion 11 . 1 . 1 and a wide portion 11 . 1 . 2 . The narrow portion 11 . 1 . 1 has a diameter smaller than a diameter of a main section 10 . 3 . 1 of the plunger 10 . 3 but wider than the diameter of a locking section 10 . 3 . 2 of the plunger 10 . 3 . When the gas spring 10 is in its compressed state, the locking section 10 . 3 . 2 is right outside the proximal end of the cylinder 10 . 1 . As long as the trigger button 11 is not pressed the locking section 10 . 3 . 2 is held in the narrow portion 11 . 1 . 1 of the aperture. The main section 10 . 3 . 1 is thicker than the narrow portion 11 . 1 . 1 so the gas spring 10 is locked. When the trigger button 11 is being depressed the wide portion 11 . 1 . 2 becomes aligned with the plunger 10 . 3 , thus allowing the main section 10 . 3 . 1 to pass through the aperture and the gas spring 10 to expand. Beyond the locking section 10 . 3 . 2 in proximal direction P, the plunger 10 . 3 comprises a shoulder 10 . 3 . 3 followed by a pin 10 . 3 . 4 with the shoulder 10 . 3 . 3 having a greater diameter than the pin 10 . 3 . 4 . A plunger front part 10 . 3 . 5 is telescoped with the pin 10 . 3 . 4 . A plunger spring 10 . 6 is arranged on the pin 10 . 3 . 4 in a manner to bias the plunger front part 10 . 3 . 5 against the shoulder 10 . 3 . 3 and the rest of the plunger 10 . 3 . A valve 10 . 5 is arranged in or near a proximal face of the cylinder 10 . 1 . A sequence of operation of the auto-injector 1 is as follows: The user assembles the packaged syringe 1 . 2 to a proximal end of the reusable engine 1 . 1 . The connection may be a screw connection as illustrated. Alternative embodiments may involve bayonet connections etc. The assembled auto-injector 1 is shown in FIGS. 1 a , 1 b and 3 . Then the user removes the cap 2 thereby also removing a protective needle sheath 16 arranged on the needle 4 . This situation is illustrated in FIG. 2 . The user places the proximal end P of the auto-injector 1 , i.e. the transfer sleeve 7 against an injection site, e.g. a patient's skin. As the auto-injector 1 is pushed against the injection site, the transfer sleeve 7 translates by a small distance in distal direction D against the bias of at least one resilient member 7 . 1 and displaces the button latch 12 along the longitudinal axis of the auto-injector 1 from the locking position into the unlocked position. This removes the obstruction preventing depression of the trigger button 11 . The button latch 12 may be biased in the locking position by a bias spring (not illustrated). Another bias spring may be provided for biasing the trigger button 11 outwardly (not illustrated). The user depresses the trigger button 11 to commence an injection cycle. As the trigger button 11 is depressed, the dog 11 . 1 preventing movement of the plunger 10 . 3 is disengaged. The piston 10 . 2 and plunger 10 . 3 start to move in proximal direction P due to the force of the compressed gas G in the cavity. As the plunger 10 . 3 moves through the cylinder 10 . 1 , gas, e.g. air on a proximal, low-pressure side of the piston 10 . 2 is displaced and vented into the atmosphere. The valve 10 . 5 is arranged to restrict the venting thereby introducing a speed dependent force, hence a damping opposing the plunger 10 . 3 motion. The valve 10 . 5 is defined to ensure a damping rate greater than a damping force generated due to friction between the stopper 5 and the inner wall of the syringe 3 and due to hydraulic resistance of the liquid medicament M forced through the small fluid channel in the hollow needle 4 . The force on the piston 10 . 2 from the compressed gas G is always distributed between this damping force and any load applied to the proximal end of the plunger 10 . 3 . Upon contact with the stopper 5 , the plunger 10 . 3 applies a force to the stopper 5 . A syringe spring 13 arranged in the packaged syringe 1 . 2 , the syringe spring 13 arranged to bias the syringe 3 in distal direction with respect to the transfer sleeve 7 . The force from the plunger 10 . 3 is transferred to the syringe spring 13 since a friction force generated by the friction between the stopper 5 and the inner wall of the syringe 3 and by the hydraulic resistance of the liquid medicament M forced through the small fluid channel in the hollow needle 4 is greater than the force of the syringe spring 13 and the force required to insert the needle 4 into the injection site. Thus, the syringe spring 13 is compressed and the needle 4 is inserted into the injection site. An injection depth is controlled by the design of the packaged syringe 1 . 2 , i.e. by the distance, the syringe 3 and support sleeve 6 can travel forwardly before the syringe spring 13 is fully compressed. In alternative embodiments the injection depth may be controlled by a depth stop within the reusable engine, or within the packaged syringe. The force applied to the stopper 5 by the plunger 10 . 3 increases until the friction opposing motion of the stopper 5 within the syringe 3 is overcome. As this force increases, the plunger spring 10 . 6 will become partially compressed. Once the friction force is exceeded, the stopper 5 starts to move and the medicament M is displaced from the syringe 3 through the needle 4 into the injection site. When the stopper 5 reaches the end of travel, i.e. the syringe 3 is fully emptied, the gas spring 10 continues to move the plunger 10 . 3 . This additional motion is accommodated by the plunger spring 10 . 6 . The plunger spring 10 . 6 is defined to generate a force greater than the hydraulic force of emptying the syringe yet weaker than the force of the gas spring 10 . At full extension of the gas spring 10 , the piston 10 . 2 triggers the latch 14 that disengages the cylinder 10 . 1 from the case 9 . If a flexible diaphragm is provided in the cylinder 10 . 1 under the latch, the piston 10 . 2 would operate the latch 14 through the diaphragm to decouple the gas spring 10 from the case 9 . The cylinder 10 . 1 then translates in distal direction D under the force of the cylinder spring 15 . Since the gas spring 10 has reached its full extension, the plunger 10 . 3 is withdrawn together with the cylinder 10 . 1 . This removes the force from the stopper 5 allowing the syringe spring 13 to retract the syringe 3 and the needle 4 , whereby the needle 4 is extracted from the injection site and gets hidden inside the transfer sleeve 7 . The user may now remove the packaged syringe 1 . 2 from the reusable engine 1 . 1 . The reusable engine 1 . 1 may be reset using a tool or a base station (not illustrated). When resetting, the cylinder 10 . 1 has to be translated in proximal direction P and reengaged to the case 9 by the latch 14 . The latch 14 may be biased to return to its position locking the cylinder 10 . 1 to the case 9 . The gas spring 10 has to be recharged by pushing the plunger 10 . 3 and the piston 10 . 2 in distal direction D. The cylinder valve 10 . 5 is a one way valve. Hence, it exerts a minimal force when intaking air into the low pressure side of the cylinder 10 . 1 when resetting the reusable engine 1 . 1 . The reusable engine 1 . 1 may be combined with other types of packaged syringes 1 . 2 . An arrangement for avoiding wet injection may be optionally provided, i.e. the liquid medicament is not leaking out of the hollow needle 4 before or during needle insertion. This may be achieved by a component which couples the plunger 10 . 3 to the syringe 3 during needle insertion so the stopper 5 is not pushed. When the injection depth has been reached the plunger 10 . 3 is decoupled from the syringe 3 and coupled to the stopper 5 to inject the medicament M. The auto-injector 1 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.

1a

FIELD OF THE INVENTION The invention relates to a kit for implanting a cementable endoprosthesis according to the preamble of claim 1. BACKGROUND OF THE INVENTION Document DE 195 18 391 A1 discloses a proximal centering and sealing element for implanting a cementable endoprosthesis shaft, which element on the one hand serves as a proximal centering aid and on the other hand prevents escape of the cement in the proximal direction, as a result of which, when inserting the endoprosthesis shaft into the medullary cavity, there is an increase in the pressure of the bone cement located therein. This known combination of endoprosthesis shaft and suitably adapted centering and sealing element has the disadvantage that the depth of insertion of the endoprosthesis shaft in the medullary cavity of the femur in the proximal-distal direction can be set only with difficulty and therefore inexactly. In addition, the centering and sealing element has only a limited sealing effect and inadequate centering in the medial-lateral direction. SUMMARY OF THE INVENTION The object of the present invention is to make available a set of instruments permitting more precise implantation of a cementable endoprosthesis shaft. This object is achieved by means of a kit having the features of claim 1 . Dependent claims 2 through 17 relate to further advantageous embodiments of this kit. The object is achieved in particular by means of a kit for implanting a cementable endoprosthesis, comprising a fitting instrument and at least two components to be implanted, namely an endoprosthesis shaft and a proximal centering and/or sealing element, the shaft and the fitting instrument being designed to be able to be coupled to each other, and the centering and/or sealing element being designed to be placeable on the shaft and to be displaceable in the direction of extension of the latter, and either the fitting instrument comprising a limit stop part which forms a limit stop relative to the centering and/or sealing element, or a marking being arranged on the fitting instrument and on the shaft in order to ensure a defined mutual position between the centering and/or sealing element and the shaft. This embodiment according to the invention has the advantage that the depth of fitting of the endoprosthesis shaft in the medullary cavity of the femur can be adjusted even during implantation. Therefore, it is still possible during implantation to adjust, for example, the length of the femur or depth of fitting of the endoprosthesis shaft in such a way that after the operation has been completed, both legs are the same length. In a preferred embodiment, the kit comprises a manipulating instrument which is inserted into the medullary cavity of the femur before fitting the shaft, in order to determine the optimum depth of fitting, so that in particular an optimum leg length or optimum ligament tensioning is achieved. The optimum depth of fitting which is determined in this way is read off and the endoprosthesis shaft is then inserted into the femur corresponding to this depth of fitting. The proximal centering and/or sealing element has, in the proximal area of the femur, the task of centering the endoprosthesis shaft in the medullary cavity or sealing off the gap between medullary cavity and shaft, in order to ensure that the bone cement located in the medullary cavity cannot flow out, or of providing centering and sealing at the same time. This centering and sealing element which ensures both centering and sealing is preferably adapted in design to the geometry of the shaft in such a way that a displacement of the shaft along the sealing element in the distal direction is possible while maintaining the sealing effect. The centering and sealing element can be placed on the resected femoral neck and can be inserted at least partially into the medullary cavity in the proximal area thereof so that the endoprosthesis shaft to be inserted subsequently is inserted in the medullary cavity with all-round centering, the element additionally exerting a sealing effect so that the bone cement located in the medullary cavity is prevented from escaping. In an advantageous embodiment, the proximal centering and sealing element consists of a sleeve-shaped body extending in a proximal-distal direction, the body having two broad-side boundaries and two narrow-side boundaries which enclose an essentially rectangular inner space, and the two broad-side boundaries each forming inner side surfaces extending essentially parallel in the proximal-distal direction. This centering and sealing element is especially suitable for endoprosthesis shafts of blade-type design whose broad sides extend approximately parallel in the proximal-distal direction. In this way, a particularly good sealing effect is achieved between the centering and sealing element and the endoprosthesis shaft. A centering and/or sealing element is designed as a sleeve-shaped body whose inner space, in an advantageous embodiment, is designed such that a movement of the shaft in the proximal-distal direction is also possible during implantation of the endoprosthesis shaft. If this is desired, then the shaft would be able to settle even some time after implantation since the movement in the proximal-distal direction is not impeded. The centering and/or sealing element advantageously consists of a polymerized bone cement, in particular polymethyl methacrylate (PMMA). During implantation, this centering and/or sealing element binds chemically to the bone cement present to form a particularly homogeneous connection. However, the centering and/or sealing element can also consist of another material, in particular of a metal such as a biocompatible titanium alloy. The centering and/or sealing element satisfies either a centering or a sealing function, or both functions simultaneously, said functions being: to center the shaft in the proximal section of the medullary cavity; to guide the shaft centrally in the proximal-distal direction during fitting of the shaft; to prevent tilting in the medial-lateral direction and also twisting of the shaft; to seal off the gap occurring between the shaft and the femur in the proximal area so that pressure is exerted on the bone cement located in the medullary cavity. The centering and/or sealing element has, in the proximal direction, an end face which is advantageously used as a reference surface. The centering and/or sealing element is preferably inserted into the medullary cavity in such a way that said reference surface is flush with the resected surface of the femoral neck. The endoprosthesis shaft is secured on a fitting instrument prior to insertion, a spacer element additionally being secured on the fitting instrument, said spacer element being designed in such a way that with the endoprosthesis shaft inserted deep in the medullary cavity, it lies on the reference surface of the centering and/or sealing element and prevents any further insertion of the shaft. By means of this spacer element which is available in different sizes, the depth of fitting of the endoprosthesis shaft can be adjusted exactly with respect to the resected surface. A spacer element corresponding to the desired depth of fitting is chosen and is secured on the fitting instrument prior to insertion of the endoprosthesis shaft. A kit is understood as comprising the mutually adapted parts of centering and/or sealing element, endoprosthesis shaft and fitting instrument, if appropriate in combination with one or more spacer elements, and of this kit only the centering and/or sealing element and the endoprosthesis shaft are intended to remain as implants in the body. A number of illustrative embodiments of the invention are described below with reference to figures, in which: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a perspective view of a proximal centering and/or sealing element; FIG. 2 a shows a side view of a further proximal centering and/or sealing element; FIG. 2 b shows a cross section through the element according to FIG. 2 a; FIG. 2 c shows a top view of the element according to FIG. 2 a; FIG. 3 shows a kit comprising a fitting instrument, a centering and/or sealing element, a spacer element and a shaft; FIG. 4 shows a shaft which has been inserted with a fitting instrument according to FIG. 3; FIG. 5 shows a cross section through a further illustrative embodiment of a centering and/or sealing element; FIG. 6 shows a further kit comprising a fitting instrument, a centering and/or sealing element and a shaft; FIG. 7 shows a further kit comprising a fitting instrument, a centering and/or sealing element and a shaft. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 3 shows an illustrative embodiment of a kit according to the invention, comprising an endoprosthesis shaft 4 which is designed as a straight shaft, the actual shaft 4 f having an essentially rectangular cross section with two narrow-side surfaces 4 c, 4 d and two broad-side surfaces 4 e. At the proximal end, the shaft 4 f has an internal thread 4 a and a cone 4 b for a joint head. The kit further comprises a fitting instrument 3 which has a connection rod 3 d on which a stamp 3 c is secured which opens into an adapter piece 3 b and an external thread 3 a. The kit further comprises a spacer element 2 which is designed as a sleeve-shaped, rectangular body 2 d, with two side wings 2 a which form an upper limit stop surface 2 b and a lower limit stop surface 2 c. The kit also comprises a proximal centering and/or sealing element 1 . The spacer element 2 is designed in such a way that it lies with its upper limit stop surface 2 b on the stamp 3 c. Upon insertion of the endoprosthesis shaft 4 , the lower limit stop surface 2 c comes to lie at some time on the reference surface 1 m, 1 n of the proximal centering and/or sealing element 1 and thereby limits, in the direction of extension of the shaft, the mutual positioning of endoprosthesis shaft 4 and centering and/or sealing element 1 . Since the centering and/or sealing element 1 lies with its surface 1 m, 1 n preferably flush with the resected surface of the femur during implantation, the depth of fitting of the shaft 4 f is determined by the spacer element 2 . A selection of spacer elements 2 are available to the operating surgeon, said spacer elements 2 being designed with different lengths in the proximal-distal direction C. The spacer element 2 represented in FIGS. 3 and 4 is to be regarded as only one illustrative embodiment from a large number of possible designs. The object of the spacer element 2 is to provide an upper and a lower limit stop 2 b, 2 c in order to ensure a defined depth of fitting of the shaft 4 with respect to the proximal centering and/or sealing element 1 or its reference surface 1 m, 1 n. This function can be satisfied by spacer elements 2 of widely different designs. FIG. 4 shows an endoprosthesis shaft 4 in the inserted position, the femur not being represented. After inserting a manipulating shaft into the medullary cavity, the operating surgeon determines the depth of insertion of the shaft with respect to the resection plane. From the plurality of spacer elements, the operating surgeon selects the one which ensures the intended depth of insertion. This selected spacer element 2 is secured on the stamp 3 c of the fitting instrument 3 , and the endoprosthesis shaft 4 is then screwed onto the external thread 3 a via the internal thread 4 a. The centering and/or sealing element 1 is then pushed onto the shaft 4 f from the distal direction. The endoprosthesis shaft 4 together with the centering and/or sealing element 1 , as is represented in FIG. 4, is then inserted into the medullary cavity until the spacer element 2 abuts the proximal centering and/or sealing element 1 and as far as the resection plane which forms a reference plane. The bone cement located in the medullary cavity is thereby compressed and forced out from the medullary cavity toward the centering and/or sealing element 1 . At least the inner side surfaces 1 b, 1 c, 1 d lie on the endoprosthesis shaft 4 and exert a sealing action. As long as the endoprosthesis shaft 4 does not lie with its side surface 4 d on the inner side surface 1 e, a gap 1 p is formed between these surfaces, through which gap the bone cement can escape. An operating surgeon can cover this gap 1 p, for example with his finger, and can thus control the escape of the bone cement relatively precisely by pressing his finger against the gap 1 p or uncovering said gap. The inner side surface 1 e can also be arranged with respect to the side surface 4 d, or the shaft 4 can be pushed deep into the centering and/or sealing element 1 , in such a way that a sealing effect is achieved between these two surfaces 1 e, 4 d, so that the element 1 acts simultaneously as centering and sealing element. In a preferred embodiment, the centering and/or sealing element 1 is designed, and the bone cement selected, in such a way that said bone cement flows all round the proximal centering and/or sealing element, the bone cement being forced out between the inner side surfaces 1 b, 1 c, 1 d, 1 e and the shaft 4 a and also between the outer surface of the centering and/or sealing element 1 and the femur. An illustrative embodiment of the centering and/or sealing element is described with reference to FIGS. 2 a through 2 c. The centering and/or sealing element consists of a sleeve-shaped body extending in a proximal-distal direction C, said body having two broad-side boundaries 1 q, 1 r and two narrow-side boundaries 1 f, 1 g which, as can be seen from the view according to FIG. 2 c, enclose an essentially rectangular inner space 1 a. The inner side surfaces 1 b, 1 c of the broad-side boundaries 1 q, 1 r are designed extending essentially parallel to the proximal-distal direction C and also parallel to the lateral-medial direction A. In the illustrative embodiment shown, as can be seen from FIG. 2 c, the inner side surface 1 d of the narrow-side boundary 1 g extends parallel to the proximal-distal direction C. The broad-side inner side surfaces 1 b, 1 c could also be designed extending parallel to the proximal-distal direction C, but in the illustrative embodiment shown they converge slightly in the distal direction, this having the advantage of affording an improved sealing effect between endoprosthesis shaft 4 and inner side surface 1 b, 1 c. The second narrow-side boundary 1 f has an inner side surface 1 e extending at an inclination to the inner side surface 1 d. In the illustrative embodiment shown, all the boundaries 1 q, 1 r, 1 f, 1 g have a part section 1 l which extends in the proximal-distal direction C and which forms, adjacent to the part section 1 k, a wall thickness tapering in the distal direction, as can be seen in particular from the cross section shown in FIG. 2 b. In the proximal direction, the broad-side boundaries 1 q , 1 r end in a reference surface 1 m , 1 n . This reference surface 1 m , 1 n , extending in the medial-lateral direction A, has, as can be seen from FIGS. 2 a and 2 b , a course which is bent so as to follow the course of the broad-side boundary 1 r. In contrast to the illustrative embodiment according to FIGS. 2 a through 2 c, the otherwise identically designed body 1 shown in FIG. 5 has two broad-side boundaries 1 r , 1 q which are rectilinear, i.e. they have no bend point. In contrast to the illustrative embodiment according to FIGS. 2 a through 2 c, the body 1 shown in FIG. 1 has a narrow-side boundary 1 g which is designed wider in the medial-lateral direction A and which additionally has in the center a continuous gap 10 extending in the proximal-distal direction C. The endoprosthesis is implanted, for example, as follows: The femoral neck is resected. The medullary cavity is then widened using a bone rasp. The outer shape of the centering element, i.e. the outer surfaces 1 r , 1 k , preferably corresponds to the outer shape of the bone rasp. A manipulating shaft is then inserted into the widened medullary cavity and a joint head is fitted onto this manipulating shaft. The bone rasp can if necessary also be designed to receive a joint head or can comprise a joint head and can therefore be left for the time being in the medullary cavity. The position of the joint head is then checked and the leg manipulated, for example in order to examine the leg length, and the depth of fitting of the manipulating shaft or bone rasp can be adjusted in particular in the proximal-distal direction C until an optimum position has been found for the leg. The depth of fitting of the manipulating shaft or bone rasp is then read off. The manipulating shaft or bone rasp is then removed from the medullary cavity, whereupon the bone cement is filled into the medullary cavity. Then, as is represented in FIG. 6, the centering and/or sealing element 1 is pushed over the tip of the shaft 4 f, the shaft is secured on the fitting instrument 3 , if appropriate using spacer elements 2 determining the depth of fitting, as shown in FIG. 3 or FIG. 4, whereupon the shaft is inserted into the medullary cavity. The centering and/or sealing element 1 is likewise introduced into the medullary cavity. The tapering part section 1 l facilitates reliable and centered insertion of the centering and/or sealing element 1 into the medullary cavity. The centering and/or sealing element 1 is pressed in so that the end faces 1 m , in preferably are flush with the resected surface, whereupon the shaft is inserted further until the predetermined depth of fitting is reached. The fitting instrument 3 and the optionally used spacer element 2 are then removed. In the illustrative embodiment shown, as can be seen from FIG. 2 c, the narrow-side inner side surface 1 d is designed extending in the proximal-distal direction C, the advantage of which is that this surface serves as a bearing and reference surface during insertion of the shaft 4 f , said surface 1 d causing no displacement of the shaft 4 f in the medial-lateral direction A. A distal centering element can also be arranged on the shaft tip 4 g. To achieve a sealing effect, it is necessary that the inner side surfaces 1 b , 1 c , 1 d , 1 e of the centering and/or sealing element 1 are designed to match the geometry of the shaft 4 f, so as to achieve a sealing effect. For this reason, these inner side surfaces 1 b , 1 c , 1 d , 1 e , predetermined by the shape of the corresponding shaft 4 f , can be designed in very different configurations in such a way that a sealing effect between shaft 4 f and centering and/or sealing element 1 is achieved with at the same time mutual displaceability in the proximal-distal direction C. FIG. 6 shows an illustrative embodiment of a kit which comprises an endoprosthesis shaft 4 , a distal centering and/or sealing element 1 and a fitting instrument 3 . Markings 6 are arranged on the shaft 4 in order to indicate the depth of fitting with numbers “0”, “5” and “10”. The fitting instrument 3 also has markings 6 with the same numbers. During implantation, the optimum depth of fitting is determined with a manipulating instrument, markings and numbers being arranged on the manipulating instrument. The marking lying at the resected surface is read off. The centering and/or sealing element is then anchored with its upper edge 1 m , 1 n flush with the resected surface in the medullary cavity and the bone cement is inserted into the medullary cavity. The shaft 4 is then secured on the fitting instrument 3 and introduced into the medullary cavity. During insertion, the operating surgeon can use the markings 6 to accurately determine the depth of insertion of the shaft 4 with respect to the upper edge 1 m , 1 n of the centering and/or sealing element. FIG. 7 shows a further illustrative embodiment of a kit which comprises an endoprosthesis shaft 4 , a distal centering and/or sealing element 1 and a fitting instrument 3 . The stamp 3 c comprises a securely connected limit stop part 3 e which has a limit stop surface 2 c for abutting the centering and spacer element 1 . Stamps 3 c with limit stop parts 3 e of different lengths in direction C can be provided, so that the mutual position of centering and/or sealing element 1 and shaft 4 can be set by appropriate choice of stamp 3 c.

1a