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BACKGROUND OF THE INVENTION [0001] This invention relates to a novel bioactive substance which suppresses differentiation of undifferentiated cells. DESCRIPTION OF THE RELATED ART [0002] Human blood and lymph contain various types of cells and each cell plays important roles. For example, the erythrocyte carries oxygen; platelets have hemostatic action; and lymphocytes prevent infection. These various cells originate from hematopoietic stem cells in the bone marrow. Recently, it has been clarified that the hematopoietic stem cells are differentiated to various blood cells Osteoclasts and mast cells by stimulation of various cytokines in vivo and environmental factors. In the cytokines, there have been found, for example, erythropoietin (EPO) for differentiation to erythrocytes; granulocyte colony stimulating factor (G-CSF) for differentiation to leukocytes; and platelet growth factor (mpl ligand) for differentiation to megakaryocytes which are platelet producing cells, and the former two have already been clinically applied. [0003] The undifferentiated blood cells are generally classified into two groups consisting of blood precursor cells which are destined to differentiate to specific blood series and hematopoietic stem cells which have differentiation ability to all series and self-replication activity. The blood precursor cells can be identified by various colony assays. However, identification method for the hematopoietic stem cells have not been established. In these cells, stem cell factor (SCF), interleukin-3 (IL-3), granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-6 (IL-6), interleukin-1 (IL-1) granulocyte colony stimulating factor (G-CSF) and oncostatin M have been reported to stimulate cell differentiation and proliferation. Trials for expansion of hematopoietic stem cells in vitro have been examined in order to replace bone marrow transplantation for applying hematopoietic stem cell transplantation therapy or gene therapy. However, when the hematopoietic stem cells are cultured in the presence of the above mentioned cytokines, multi-differentiation activities and self-replication activities, which are originally in the position of the hematopoietic stem cells, gradually disappeared and are changed to the blood cell precursors which are only to differentiate to specific series after 5 weeks of cultivation, and multi-differentiation activity which is one of the specific features of the hematopoietic stem cells, is lost (Wagner et al., Blood 86. 512-523, 1995). [0004] For proliferation of the blood precursor cells, a single cytokine is not sufficient, but the synergistic action of several cytokines are important. Consequently, in order to proliferate the hematopoietic stem cells while maintaining specific features of the hematopoietic stem cells, it is necessary to add cytokines which suppress differentiation together with the cytokines which proliferate and differentiate the undifferentiated blood cells. In general, may cytokines which stimulate proliferation or differentiation of cells are known, but small numbers of cytokines which suppressed cell differentiation are known. For example, leukemia inhibitory factor (LIF) has an action of proliferation of mouse embryonic stem cells without differentiation, but it has no action against the hematopoietic stem cells or blood precursor cells. Transforming growth factor (TGF-β) has suppressive action for proliferation against various cells, but no fixed actions against the hematopoietic stem cells or blood precursor cells. [0005] Not only blood cells but also undifferentiated cells, especially stem cells, are thought to be involved in tissue regeneration. These regeneration of tissues and proliferation of undifferentiated cells in each tissue can be applied in various ways by referring to the known reference (Katsutoshi Yoshizato, Regeneration—a mechanism of regeneration, 1996, Yodosha Publ. Co.). [0006] Notch is a receptor type membrane protein which is involved in regulation of nerve cells differentiation found in Drosophia. Homologues of the Notch are found in various animal kinds exceeding to the invertebrate and vertebrate including nematoda (Lin-12). Xenopus laevis (Xotch), mouse (Motch) or human (TAN-2). Ligand of the Notch in Drosophila are known. These are Drosophila Delta (Delta) and Drosophila Serrate (Serrate). Notch ligand homologues are found in various animal kinds as similar to the Notch of receptors (Artavanis-Tsakonas et al., Science 268, 225-232, 1995). [0007] Human Notch homologue, TAN-1 is found widely in the tissues in vivo (Ellisen et al., Cell 66. 649-661, 1991). Two Notch analogous molecules other than TAN-1 are reported (Artavanis-Tsakonas et al., Science 268, 225-232, 1995). Expression of TAN-1 was also observed in CD34 positive cells in blood cells by PCR (Polymerase Chain Reaction) (Milner et al., Blood 83, 2057-2062, 1994). However, in relation to humans, gene cloning of human Delta and human Serrate, which are thought to be the Notch ligand, have not been reported. [0008] In Drosophila Notch, binding with the ligand was studied and investigated in detail, and it was found that the Notch can be bound to the ligand with Ca** at the binding region, which is a repeated amino acid sequence No. 11 and No. 12 in the amino acid sequence repeat of Epidemal Growth Factor (EGF) like repeating (Fehon et al., Cell 61. 523-534, 1990, Rebay et al., ibid. 67, 687-699, 1991 and Japan. Patent PCT Unexam. Publ. 7-503123). EGF-like repeated sequences are conserved in Notch homologues of the other species. Consequently, the same mechanism in binding with ligand is estimated. An amino acid sequence which is called DSL (Delta-Serrate-Lag-2) near the amino acid terminal, and EGF-like repeated sequence as in the receptor are conserved in the ligand (Artavanis-Tsakonas et al.), Science 268, 225-232, 1995). [0009] The sequence of DSL domain is not found except for the Notch ligand molecules, and is specific to Notch ligand molecule. A common sequence of DSL domain is shown in the sequence listing, SEQ ID NO: 1 in general formula, and comparison with human Delta-1 and human Serrate-1 of the present invention and known Notch ligand molecules are shown in FIG. 1 . [0010] EGF-like sequence has been found in thrombomodulin (Jackman et al., Proc. Natl. Acad. Sci. USA 83, 8834-8838, 1986), low density lipoprotein (LDL) receptor (Russell et al., Cell 37, 577-585, 1984), and blood coagulating factor (Furie et al., Cell 53, 505-518, 1988), and is thought to play important roles in extracellular coagulation and adhesion. [0011] Recently, the vertebrate homologues of the cloned Drosophila Delta were found in chicken (C-Delta- 1) and Xenopus laevis (X-Delta-1), and it was reported that X-Delta-1 had acted through Notch in the generation of the protoneuron (Henrique et al., Nature 375, 787-790, 1995 and Chitnis et al., ibid. 375, 761-766, 1995). Vertebrate homologue of Drosophila Serrate was found in rat as rat Jagged (Jagged) (Lindsell et al., Cell 80, 909-917, 1995). According to the Lindsell et al., mRNA of the rat Jagged is detected in the spinal cord of fetal rats. As a result of cocultivation of a myoblast cell line is found. However, the rat Jagged has no action against the myoblast cell line without forced expression of the rat Notch. [0012] Considering the above reports, the Notch and ligand thereof may be involved in the differentiation regulation of the nerve cells, however, except for some myoblast cells, their actions against cells including blood cells, especially primary cells, are unknown. [0013] In the Notch ligand molecule, from the viewpoint of the prior studies on Drosophila and nematodae, the Notch ligand has specifically a structure of DSL domain which is not found other than in the Notch ligand. Consequently, the fact of having DSL domain means equivalent to ligand molecule for the Notch receptor. SUMMARY AND OBJECTS OF THE INVENTION [0014] As mentioned above, concerning undifferentiated cells, proliferation that maintains their specificies has not been achieved. Major reasons are that factors suppressing differentiation of the undifferentiated cells are not sufficiently known. An object of the present invention is to provide a compound originated from novel factors which can suppress differentiation of the undifferentiated cells. [0015] We have set up a hypothesis that the Notch and its ligand have action of differential regulation not only for neuroblasts and myoblasts but also for various undifferentiated cells, especially blood undifferentiated cells. However, in case of clinical application in the humans, prior known different species such as chicken or Xenopus laevos type notch ligand have problems of species specificities and antigenicities. Consequently, to obtain previously unknown human Notch ligand is essentially required. We had an idea that a molecule having DSL domain and EGF-like domain which are common to Notch ligand molecules and a ligand of the human Notch (TAN-1 etc.), which is a human Delta Homologue (hereinafter designated as human Delta) and human Serrate homologue (hereinafter designated as human Serrate), may be found. Also we have an idea that these findings may be a candidate for drugs useful for differential regulation of the undifferentiated cells, and we have tried to find out the same. [0016] In order to find out human Notch ligands, we have analyzed amino acid sequences which are conserved in animals other than humans, and tried to find out genes by PCR using mixed primers of the corresponding DNA sequence. As a result of extensive studies, we have succeeded in isolation of cDNAs coding amino acid sequences of two new molecules, novel human Delta-1 and novel human Serrate-1, and have prepared the expression systems of protein having various forms using these cDNAs. Also we have established purification method of the proteins which were purified and isolated. [0017] Amino acid sequences of novel human Delta-1 are shown in the sequence listings, SEQ ID NO: 2-4. DNA sequence coding these sequence is shown in the sequence listing, SEQ ID NO: 8. Amino acid sequence of novel human Serrate-1 is shown in the sequence listings, SEQ ID NO: 5-7. DNA sequence coding these sequence is shown in the sequence listing. SEQ ID NO: 10. [0018] Physiological actions of the these prepared proteins were searched by using nerve undifferentiated cells, preadipocytes, hepatocytes, myoblasts, skin undifferentiated cells, blood undifferentiated cells and immuno undifferentiated cells. As a result, we have found that novel human Delta-1 and novel human Serrate-1 had an action of differentiation-suppressive action to primary blood undifferentiated cells, and had a physiological action to maintain undifferentiated state. [0019] Such actions to the blood undifferentiated cells have never been reported previously, and is a new discovery. No significant toxic actions were noted in the toxicity studies on mice, and useful pharmaceutical effects were suggested. Consequently, the pharmaceutical preparations containing the molecule of the present invention, medium containing the molecule of the present invention, and the device having immobilized thereon the molecule of the present invention are novel drugs and medical materials which can maintain the blood undifferentiated cells in the undifferentiated conditions. Antibodies against human Delta-1 and human Serrate-1 are prepared by using antigens of the said human Delta-1 and human Serrate-1, and purification method of the said antibodies are established. The present invention has been completed accordingly. [0020] The present invention further related relates to a polypeptide comprising amino acid sequence of SEQ ID NO: 1 of the sequence listing encoded in a gene of human origin, a polypeptide comprising at least amino acid sequence of SEQ ID NO: 2 or NO: 5 of the sequence listing, the polypeptide comprising amino acid sequence of SEQ ID NO: 3 of the sequence listing, the polypeptide comprising amino acid sequence of SEQ ID NO: 4 of the sequence listing, the polypeptide comprising amino acid sequence of SEQ ID NO: 6 of the sequence listing, the polypeptide comprising amino acid sequence of SEQ ID NO: 7 of the sequence listing, the polypeptide having differentiation suppressive action against undifferentiated cells, the polypeptide in which undifferentiated cells are undifferentiated cells other than those of the brain and nervous system or muscular system cells, and the polypeptide in which undifferentiated cells are the undifferentiated blood cells. The present invention also relates to a pharmaceutical composition containing the polypeptides, and the pharmaceutical composition in which use there is as a hematopoietic activator. The present invention further relates to a cell culture medium containing the polypeptides, and the cell culture medium in which the cell is the undifferentiated blood cell. The present invention still further relates to a DNA coding a polypeptide at least having amino acid sequence of SEQ ID NO: 2 or NO: 5 of the sequence listing, the DNA having DNA sequence 242-841 of SEQ ID NO: 8 or DNA sequence 502-1095 of SEQ ID NO: 10 of the sequence listing, the DNA coding the polypeptide having amino acid sequence of SEQ ID NO: 3 of the sequence listing, the DNA coding the polypeptide having amino acid sequence of SEQ ID NO: 4 of the sequence listing, the DNA having DNA sequence 242-2347 of the SEQ ID NO: 8 of the sequence listing, the DNA coding the polypeptide having amino acid sequence of SEQ ID NO: 6 of the sequence listing, the DNA having DNA sequence 502-3609 of SEQ ID NO: 10 of the sequence listing, the DNA coding the polypeptide having amino acid sequence of SEQ ID NO: 7 of the sequence listing, and the DNA having DNA sequence 502-4062 of SEQ ID NO: 10 of the sequence listing. The present invention still further relates to a recombinant DNA made by ligating a DNA selected from the groups of DNA hereinabove and a vector DNA which can express in the host cell, a cell transformed by the recombinant DNA, and a process for production of polypeptide by culturing cells and isolating the thus produced compound. The present invention still further relates to an antibody specifically recognizing the polypeptide having the amino acid sequence of SEQ ID NO: 7 of the sequence listing. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0021] The present invention is explained in details in the following: [0022] Preparation of cDNA necessary for gene manipulation, expression analysis by Northern blotting, screening by hybridization, preparation of recombinant DNA, determination of DNA base sequence and preparation of cDNA library, all of which are series of molecular biological experiments, can be performed according to a description of the conventional textbook for the experiments. The above conventional textbook of the experiments is, for example, Maniatis et al. ed. Molecular Cloning, A laboratory manual, 1989, Eds., Sambrook, J., Fritsch, E. F. and Maniatis, T., Cold Spring Harbor Laboratory Press. [0023] A polypeptide of the present invention has at least one of the polypeptides in the sequence listing SEQ ID NO: 1-7. A mutant and allele which naturally occur in the nature are included in the polypeptide of the present invention unless the polypeptides of the sequence listing, SEQ ID NO: 1-7 lose their properties. Modification and substitution of amino acids are described in details in the patent application by the name of Benntt et al. (National Unexam. Publ. WO96/2645) and can be prepared according to the description thereof. [0024] A DNA sequence coding polypeptides of the sequence listing, SEQ ID NO: 2-4 is shown in the sequence listing, SEQ ID NO: 8, and a DNA sequence coding polypeptides of the sequence listing, SEQ ID NO: 5-7 is show in the sequence listing, SEQ ID NO: 10, together with their amino acid sequences. In these DNA sequences, even if amino acid level mutation is not generated, naturally isolated chromosomal DNA or cDNA thereof may have a possibility to mutate in the DNA base sequence as a result of degeneracy of genetic code without changing amino acid sequence coded by the DNA. A 5′-untranslated region and 3′-untranslated region are not involved in amino acid sequence determination of the polypeptide, so DNA sequences of these regions are easily mutated. The base sequence obtained by these degeneracies of genetic codes is included in the DNA of the present invention. [0025] Undifferentiated cells in the present invention are defined as cells which can grow by specific stimulation, and cells which can be differentiated to the cells having specific functions as a result of the specific stimulations. These include undifferentiated cells of the skin tissues, undifferentiated cells of the brain and nervous systems, undifferentiated cells of the muscular systems and undifferentiated cells of the blood cells. These cells include the cells of self-replication activity which are called stem cells, and the cells having an ability to generate the cells of these lines. The differentiation-suppressive action means suppressive action for autonomous or heteronomous differentiation of the undifferentiated cells, and is an action for maintaining undifferentiated condition. The brain and nervous undifferentiated cells can be defined as cells having ability to differentiate to the cells of the brain or nerve having specific functions by specific stimulation. The undifferentiated cells of the muscular systems can be defined as cells having ability to differentiate to the muscular cells having specific functions by specific stimulation. The blood undifferentiated cells in the present invention can be defined as cell groups consisting of the blood precursor cells which are differentiated to the specific blood series identified by blood colony assay, and hematopoietic stem cells having differentiation to every series and self-replication activities. [0026] In the sequence listing, amino acid sequence in SEQ ID NO: 1 shows general formula of common amino acid sequence of DSL domain which is a common domain structure of the Notch ligand molecules, and at least this domain structure corresponds to the sequence listing, AMINO ACIDS 158-200 of the human Delta-1, or the sequence listing AMINO ACIDS 156-198 of the human Serrate-1. [0027] The amino acid sequence in the sequence listing, SEQ ID NO: 2 is a sequence of the active center of the present invention of human Delta-1 minus the signal peptide, i.e. amino acid sequence from the amino terminal to DSL domain, and corresponds to an amino acid No. 1 to 200 in SEQ ID NO: 4 of the mature full length amino acid sequence of human Delta-1 of the present invention. The amino acid sequence in SEQ ID NO: 3 is amino acid sequence of extracellular domain of the present invention of human Delta-1 minus the signal peptide, and corresponds to an amino acid No. 1 to 520 in SEQ ID NO: 4 of the mature full length amino acid sequence of human Delta-1 of the present invention. The amino acid sequence of SEQ ID NO: 4 is the mature full length amino acid sequence of the human Delta-1 of the present invention. [0028] The amino acid sequence in the sequence listing, SEQ ID NO: 5 is a sequence of the active center of the present invention of human Serrate-1 minus the signal peptide, i.e. amino acid sequence from the amino terminal to DSL domain, and corresponds to an amino acid No. 1 to 198 in SEQ ID NO: 7 of the mature full length amino acid sequence of human Serrate-1 of the present invention. The amino acid sequence in SEQ ID NO: 6 is amino acid sequence of extracellular domain of the present invention of human Serrate-1 minus the signal peptide, and corresponds to an amino acid No. 1 to 1036 in SEQ ID NO: 7 of the mature full length amino acid sequence of human Serrate-1 of the present invention. The amino acid sequence of SEQ ID NO: 7 is the mature full length amino acid sequence of the human Serrate-1 of the present invention. [0029] The sequence of SEQ ID NO: 8 is the total amino acid sequence of human Delta-1 of the present invention and cDNA coding the same, and the sequence of SEQ ID NO: 10 is total amino acid sequence of human Serrate-1 of the present invention and cDNA coding the same. [0030] The left and right ends of the amino acid sequences in the sequence listing indicate amino terminal (hereinafter designated as N-terminal) and carboxyl terminal (hereinafter designated as C-terminal), respectively, and the left and right ends of the nucleotide sequences are 5′-terminal and 3′-terminal, respectively. [0031] Cloning of human Notch ligand gene can be performed by the following method. During the evolution of the organisms, a part of amino acids sequences of the human Notch ligand is conserved. DNA sequence corresponding to the conserved amino acid sequence is designed, and is used as a primer of RT-PCR (Reverse Transcription Polymerase Chain reaction), then a PCR template of the human origin is amplified by PCR reaction, thereby fragments of human Notch ligand can be obtainable. Furthermore, RT-PCR primer is prepared by applying the known DNA sequence information of the Notch ligand homologue of the organisms other than humans, and the known gene fragments can be possibly obtained from PCR template of the said organisms. [0032] In order to perform PCR for obtaining fragments of human Notch ligand, PCR for DSL sequence is considered, but a large number of combinations of DNA sequence corresponding to amino acid sequence conserved in this region can be expected, and a design for PCR is difficult. As a result, PCR of the EGF-like sequence has to be selected. As explained hereinbefore, since EFG-like sequence is conserved in a large number of molecules, to obtain the fragments and identification are extremely difficult. [0033] We have designed and prepared about 50 PCR primer sets, for example, the primer set of the sequence shown in Example 1, PCR was performed with these primer sets by using PCR template of cDNA prepared from poly A+ RNA of various tissues of human origin, and more than 10 PCR products from each tissue were subcloned, as well as performing sequencing for more than 500 types. A clone having a desired sequence could be identified. Namely, the obtained PCR product is cloned in the cloning vector, transforming the host cells by using recombinant plasmid which contains the PCR product, culturing the host cells containing the recombinant plasmid on a large scale, purifying and isolating the recombinant plasmid, checking the DNA sequence of PCR product which is inserted into the cloning vector, and trying to obtain the gene fragment which may have a sequence of human Delta-1 by comparing with the sequence of the known Delta of other species. We have succeeded to find out the gene fragment which contains a part of cDNA of human Delta-1, the same sequence of DNA sequence from 1012 to 1375 described in the sequence listing, SEQ ID NO: 8. [0034] We have also designed and prepared about 50 PCR primer sets, for example, the primer set of the sequence shown in Example 3, and PCR was performed with these primer sets by using PCR template of cDNA prepared from poly A+ RNA of various tissues of human origin, and more than 10 PCR products from each tissue were subcloned, as well as performing sequencing for more that 500 types. A clone having a desired sequence could be identified. Namely, the obtained PCR product is cloned in the cloning vector, transforming the host cells by using recombinant plasmid which contains the PCR product, culturing the host cells containing the recombinant plasmid on a large scale, purifying and isolating the recombinant plasmic, checking the DNA sequence of PCR product which is inserted into the cloning vector, and trying to obtain the gene fragment which may have a sequence of human Serrate-1 by comparing with the sequence of the known Serrate of other species. We have succeeded to find out the gene fragment which contains a part of cDNA of human Serrate-1, the same sequence of DNA sequence from 1272 to 1737 described in the sequence listing, SEQ ID NO: 10. [0035] A full length of the objective gene can be obtained form the human genomic gene library or cDNA library by using the thus obtained human Delta-1 fragment or human Serrate-1 gene fragment. The full length cloning can be made by isotope labeling and non-isotope labeling with the partial cloning gene, and screening the library by hybridization or other method. Isotope labeling can be performed by, for example, terminal labeling by using [ 32 P] γ-ATP and T4 polynucleotide kinase, or other labeling methods such as nick translation or primer extension method can be applied. In another method, human originated cDNA library is ligated into the expression vector, expressing by COS-7 or other cells, and screening the objective gene by expression cloning to isolate cDNA of the ligand. In the expression cloning, a cell sorter fractionation method which is applied with binding with polypeptide containing amino acid sequence of prior known 4 Notches such as TAN-1, and a detection method by film emulsion using radioisotope can be mentioned. In this specification, methods for obtaining genes of human Delta-1 and human Serrate-1 are explained, and in addition to that obtaining the Notch ligand homologue gene of the other organism is important for analysis of ligand action. This may be made by the same treatment. The obtained gene is subjected to DNA sequence determination and amino acid sequence can be estimated. [0036] As shown in Example 2, gene fragments containing human Delta-1 PCR product are labeled with radioisotope to prepare hybridization probe screening is performed using cDNA of human placenta origin as the screening library. DNA sequences of the thus obtained clones are determined, and the clone is obtained containing DNA nucleotide sequence shown in the sequence listing. SEQ ID NO: 8, and shown to have the amino acid sequence coded in the sequence listing. SEQ ID NO: 4. We have succeeded in cloning cDNA coding fill length of amino acids sequence of human Delta-1. [0037] These sequences were compared with the data base (Genbank release 89, June, 1995), and found that these were novel sequences. The said amino acid sequence was analyzed in hydrophilic part and hydrophobic part according to a method by Kyte-Doolittle (J. Mol. Biol. 157: 105, 1982). A result indicated that human Delta-1 of the present invention is expressed on cells as a cellular membrane protein having a transmembrane domain. [0038] As shown in Example 4, gene fragments containing human Serrate-1 PCR product are labeled with radioisotope to prepare hybridization probe, screening is performed using cDNA of human placenta origin as the screening library, DNA sequences of the thus obtained clones are determined and the clone is obtained containing DNA nucleotide sequence shown in the sequence listing, SEQ ID NO: 10, and shown to have the amino acid sequence coded in the sequence listing, SEQ ID NO: 7. In this screening, an intracellular part of gene sequence coding a full length of amino acids sequence, namely a peripheral part of termination codon cannot be cloned. Consequently, as shown in Example 4, gene cloning is performed by RACE method (rapid amplification of cDNA ends, Frohman et al., Proc. Nati. Acad. Sci. U.S.A. 85, 8998-9002, 1988) and finally succeeded in cloning of cDNA coding full length of amino acid sequence of human Serrate-1. [0039] These sequences were compared with the data base (Genbank release 89, June, 1995, and found that these were novel sequences. The said amino acid sequence was analyzed in hydrophilic part and hydrophobic part according to a method by Kyte-Doolittle (J. Mol. Biol. 157: 105, 1982). A result indicated that human Serrate-1 of the present invention is expressed on cells as a cellular membrane protein having a transmembrane domain. [0040] Examples of plasmids integrated with cDNA are, for example, E. coli originated pBR322, pUC18, pUC19, pUC118 and pUC119 (Takara Shuzo Co., Japan), but other plasmids can be used if they can replicate and proliferate in the host cells. Examples of phage vectors integrated with cDNA are, for example, λgt10 and λgt11, but other vectors can be used if they can grow in the host cells. The thus obtained plasmids are transducted into suitable host cells such as genus Escherichia and genus Bacillus using calcium chloride method. Examples of the above genus Escherichia are Eseherichia coli K12HB101, MC1061, LE392 and HM109. Example of the above genus Bacillus is Bacillus subtilis MI114. Phage vector can be introduced into the proliferated E. coli by the in vitro packaging method (Enquist and Sternberg, Meth. Enzymol., 68, 281-, 1979). [0041] According to the analysis of amino acid sequence of the human Delta-1, amino acid sequence of a precursor of human Delta-1 consists of 723 amino acids residue shown in the sequence listing, SEQ ID NO: 8, and the signal peptide domain is estimated to correspond to an amino acid sequence of 21 amino acids residue from No. −21 methionine to No. −1 serine of the sequence listing; extracellular domain: 520 amino acids residue from No. 521 proline to No. 552 leucine; and intracellular domain: 150 amino acids region from No. 553 glutamine to No. 702 valine. These domains are estimated domain construction from amino acid sequences, and actual presence form may differ from the above structure, and constitutional amino acids of each domain hereinabove defined may have possibility to change 5 to 10 amino acids sequence. [0042] According to a comparison in amino acid sequence of human Delta-1 and Delta homologue of the other organisms, the homologies with Drosophila Delta, chick Delta and Xenopus laevis are 47.6%, 83.3% and 76.2%, respectively. The human Delta-1 of the present invention is different from these Deltas and is novel substance which is clarified at first by the present inventors. Search from all of organisms in the above data base indicated that polypeptides having the identical sequence of the human Delta-1 could not be found. [0043] The homologues of Notch ligand have evolutinally conserved common sequence, i.e. repeated DSL sequence and EGF-like sequence: As a result of comparison with amino acid sequence of human Delta-1, these conserved sequence is estimated. Namely, DSL sequence corresponds to 43 amino acids residue from No. 158 cysteine to No. 200 cysteine of the amino acid sequence in the sequence listing, SEQ ID NO: 4. EGF-like sequence exists with 8 repeats wherein, in the amino acid sequence in the sequence listing SEQ ID NO: 4, the first EGF-like sequence from No. 205 cysteine to No. 233 cysteine; the second EGF-like sequence from No. 236 cysteine to No. 264 cysteine; the third EGF-like sequence from No. 271 cysteine to No. 304 cysteine; the fourth EGF-like sequence from No. 311 cysteine to No. 342 cysteine; the fifth EGF-like sequence from No. 349 cysteine to No. 381 cysteine; the sixth EGF-like sequence from No. 388 cysteine to No. 419 cysteine; the seventh EGF-like sequence from No. 426 cysteine to No. 457 cysteine; and the eighth EGF-like sequence from No. 464 cysteine to No. 495 cysteine. [0044] A part of sugar chain attached is estimated from amino acid sequence of the human Delta-1 may be No. 456 asparagine residue in the sequence listing, SEQ ID NO: 4 as a possible binding site of N-glycoside bonding for N-acetyl-D-glucosamine. O-glycoside bond of N-acetyl-D-galactosamine is estimated to be a serine or threonine residue rich part. Protein bound with sugar chain is generally thought to be stable in vivo and to have strong physiological activity. Consequently, in the amino acid sequence of polypeptide having sequence of the sequence listing, SEQ ID NO: 2, 3 or 4, polypeptides having N-glucoside or O-glucoside bond with sugar chain of N-acetyl-D-glucosamine or N-acetyl-D-galactosamine is included in the present invention. [0045] According to the analysis of amino acid sequence of the human Serrate-i, amino acid sequence of a precursor of human Serrate-1 consists of 1218 amino acids residue shown in the sequence listing, SEQ ID NO: 10, and the signal peptide domain is estimated to correspond 31 amino acids residue in the amino acid sequence from No. −31 methionine to No. −1 alanine of the sequence listing; extracellular domain: 10366 amino acids residue from No. 1 serine to No. 1036 asparagine; transmembrane domain: 26 amino acids residue from No. 1037 phenylalanine to No. 1062 leucine; and intracellular domain: 106 amino acids domain from No. 1063 arginine to No. 1187 valine. These domains are estimated domain construction from amino acid sequences, and actual presence form may differ from the above structure, and constitutional amino acids of each domain hereinabove defined may have possibility to change 5 to 10 amino acids sequence. [0046] According to a comparison in amino acid sequence of human serrate-1 and Serrate homologue of the other organisms, the homologies with Drosophila Serrate, and rat Jagged are 32.1% and 95.3%, respectively. The human Serrate-1 of the present invention is different from these Serrates and is novel substance which is clarified at first by the present inventors. Search from all of organisms in the above data base indicated that polypeptides having the identical sequence of the human Serrate-1 could not find out. [0047] The homologues of Notch ligand have evolutionally conserved common sequence, i.e. repeated DSL sequence and EGF-like sequence. As a result of comparison with amino acid sequence of human Serrate-1 and other Notch ligand homologues, these conserved sequence is estimated. Namely, DSL sequence corresponds to 43 amino acids residue from No. 156 cysteine to No. 198 cysteine of the amino acid sequence in the sequence listing, SEQ ID NO: 7. EGF-like sequence exists with 16 repeats wherein, in the amino acid sequence in the sequence listing, SEQ ID NO: 7, the first EGF-like sequence from No. 205 cysteine to No. 231 cysteine; the second EGF-like sequence from No. 234 cysteine to No. 262 cysteine; the third EGF-like sequence from No. 269 cysteine to No. 302 cysteine; the fourth EGF-like sequence from No. 309 cysteine to No. 340 cysteine; the fifth EGF-like sequence from No. 356 cysteine to No. 378 cysteine; the sixth EGF-like sequence from No. 423 cysteine to No. 453 cysteine; the eighth EGF-like sequence from No. 462 cysteine to No. 453 cysteine; the nineth EGF-like sequence from No. 498 cysteine to No. 529 cysteine; the 10 th EGF-like sequence from No. 536 cysteine to No. 595 cysteine; the 11th EGF-like sequence from No. 602 cysteine to No. 633 cysteine; the 12 th EGF-like sequence from No. 640 cysteine to No. 671 cysteine; the 13 th EGF-like sequence from No. 678 cysteine to No. 709 cysteine; the 14 th EGF-like sequence from No. 717 cysteine to No. 743 cysteine; and the 16 th EGF-like sequence from No. 793 cysteine to No. 824 cysteine. However, the 10 th EGF-like sequence has irregular sequence containing 10 residues of cysteine. [0048] A part of sugar chain attached is estimated from amino acid Sequence of the human Serrate-1 may be No. 112, 131, 186, 351, 528, 554, 714, 1014 and 1033 asparagine residue in the sequence listing. SEQ ID NO: 7 as a possible binding site of N-glycoside bonding for N-acetyl-D-glycosamine. O-glycoside bond of N-acetyl-D-galactosamine is estimated to be a serine or threonine residue rich part, Protein bound with sugar chain is generally thought to be stable in vivo and to have strong physiological activity. Consequently, in the amino acid sequence of polypeptide having sequence of the sequence listing, SEQ ID NO: 5, 6 or 7, polypeptides having N-glucoside or O-glucoside bond with sugar chain of N-acetyl-D-glucosamine or N-acetyJ-D-galactosamine is included in the present invention. [0049] As a result of studies on binding of Drosophila Notch and its ligand, amino acid region necessary for binding with ligand of Drosophila Notch with the Notch is from N-terminal to DSL sequence of the matured protein, in which signal peptide is removed (Japan. Pat. PCT Unexam. Publ. No. 7-503121). This fact indicates that a domain necessary for expression of ligand action of human Notch ligand molecule is at least the DSL domain. i.e. a domain containing amino acid sequence of the sequence listing, SEQ ID NO: 1, and a domain at least necessary for expression of ligand action of human Delta-1 is novel amino acid sequence shown in the sequence listing, SEQ ID NO: 2, and further a domain at least necessary for expression of ligand action of human Serrate-1 is novel amino acid sequence shown in the sequence listing, SEQ ID NO: 5. [0050] An mRNA of human Delta-1 can be detected by using DNA coding a part or all of gene sequence in the sequence listing, SEQ ID NO: 8, and at mRNA of human Serrate-1 can be detected by using DNA coding a part or all of gene sequence in the sequence listing, SEQ ID NO: 10. For example, a method for detection of expression of these genes can be achieved by applying with hybridization or PCR by using complementary nucleic acids of above 12 mer or above 16 mer, preferably above 18 mer having nucleic acid sequence of a part of sequence in the sequence listing, SEQ ID NO: 8 or 10, i.e. antisense DNA or antisense RNA, its methylated, methylphosphated, deaminated, or thiophosphated derivatives. By the same method, detection of homologues of the gene of other organisms such as mice or gene cloning can be achieved. Further cloning of genes in the genome including humans can be made. Using these genes cloned by such like methods, further detailed functions of the human Delta-1 or human Serrate-1 of the present invention can be clarified. For example, using the modern gene manipuration techniques, every methods including transgenic mouse, gene targeting mouse or double knockout mouse in which genes relating to the gene of the present invention are inactivated, can be applied. If abnomalities in the genome of the present gene is found, application to gene diagnosis and gene therapy can be made. [0051] A transformant in which vector pUCDL-IF, which contains cDNA coding total animo acid sequence of human Delta-1 of the present invention, is transformed into E.coli JM109, has been deposited in the National Institute of Bioscience and Human-Technology, Agency of Industrial Science and Technology, MITI, of 1-1-3, Higasi, Tsukuba-shi, Ibaragi-ken, Japan, as E. coli: JM109-pUCDL-1F. Date of deposit was Oct. 28, 1996, and deposition No. is FBRM BP-5728. A transformant in which vector pUCSR-1, which contains cDNA coding total animo acid sequence of human Serrate-1 of the present invention, is transformed into E.coli JM109, has been deposited in the National Institute of Bioscience and Human-Technology, Agency of industrial Science and Technology, MITI, of 1-1-3, Higasi, Tsukuba-shi, Ibaragi-ken, Japan, as E. coli: JM109-pUCSR-1. Date of deposit was Oct. 28, 1996, and deposition No. is FBRM BP-5726. [0052] Exprssion and purification of various forms of human Delta-1 and human Serrate-1 using cDNA coding amino acid sequence of human Delta-1 and human Serrate-1 isolated by the above methods are known in the references (Kriegler, Gene Transfer and Expression—A Laboratory Manual Stockton Press, 1990 and Yokota et al. Biomanual Series 4, Gene transfer and expression and analysis, Yodosha Co., 1994). A cDNA coding the amino acid sequence of the isolated said human Delta-1 and human Serrate-1 is ligated to preferable expression vector and is produced in the host cells of eukaryotic cells such as animal cells and insect cells or prokaryotic cells such as bacteria. [0053] In the expression of human Delta-1 and human Serrate-1 of the present invention. DNA coding polypeptide of the present invention may have the translation initiation codon in 5′-terminal and translation termination codon in 3′-terminal. These translation initiation codon and translation termination codon can be added by using preferable synthetic DNA adapter. Further for expression of the said DNA, promoter is linkaged in the upstream of the DNA sequence. Examples of vector are plasmid originated from Bacullus, plasmid originated from yeast or bacteriophage such as λ-phage and animal virus such as retrovirus and vaccinia virus. [0054] Examples of promoters used in the present invention are any promoters preferable for corresponding to the host cells used in gene expression. [0055] In case that the host cell in the transformation is genus Eseherichia, tac-promoter, trp-promoter and lac-promoter are preferable, and in case of host of genus Bacullus, SP01 promoter and SP02 promoter are preferable, and in case of host of yeast, PGK promoter, GAP promoter and ADH promoter are preferable. [0056] In case that the host cell is animal cells, a promoter originated from SV40 such as SRα promoter as described in Example 51 promoter of retrovirus, metallothionein promoter and heatshock promoter can be applied. [0057] Polypeptide of the present invention can be expressed by using the expression vector having ability to be used by any person skilled in the arts. [0058] Expression of the polypeptide of the present invention can be made by using only DNA coding the amino acid sequence of the sequence listing, SEQ ID NO: 2, 3, 4, 5, 6 or 7. However, the protein added with specific function can be produced by using DNA, to which added cDNA coding the known antigen epitope for easier detection of the produced polypeptide or added cDNA coding the immunoglobulin Fc for forming multimer. [0059] As shown in Example 5, we have prepared expression vectors, which express extracellular proteins of human Delta-1, as follows: 1) DNA coding the amino acids from No. 1 to 520 in amino acid sequence in the sequence listing, SEQ ID NO: 3, 2) DNA coding chimera protein to which added polypeptide having 8 amino acid, i.e. an amino acid sequence consisting of Asp Tyr Lys Asp Asp Asp Asp Lys (hereinafter, designates FLAG sequence, the sequence listing, SEQ ID NO: 12), in the C-terminal of the amino acids from No. 1 to 520 in amino acid sequence in the sequence listing, SEQ ID NO: 3, and 3) DNA coding chimera protein to which added Fc sequence below the hinge region of human IgG1 (refer to International Patent Publ. WO96/11221 in the C-terminal of the amino acids from No. 1 to 520 in amino acid sequence in the sequence listing, SEQ ID NO:3, and to have dimer structure by disulfide bond in the hinge region, are ligated individually with the expression vector pMKITNeo (Maruyama et al. Japan Molecular Biology Soc. Meeting Preliminary lecture record, obtainable from Dr. Maruyama in Tokyo Medical and Dental College, containing promoter SRα) to prepare extracellular expression vectors of human Delta-1. [0063] The full-length expression vectors of the human Delta-1 as the expression vectors, which express full-length proteins of the human Delta-1, can be prepared as follows. 4) DNA coding amino acids from No. 1 to 702 in the sequence listing, SEQ ID NO: 4 and 5) DNA coding chimera protein to which added polypeptide having FLAG sequence in the C-terminal of amino acids from No. 1 to 702 in the sequence listing, SEQ ID NO: 4 are ligated individually with the expression vector pMKITNeo to prepare the full-length expression vectors of human Delta-1. The transformant is prepared by using expression plasmid containing DNA coding the thus constructed said human Delta-1. [0066] As shown in Example 6, we have prepared expression vectors, which express extracellular proteins of human Serrate-1, as follows. 6) DNA coding the amino acids from No. 1 to 1036 in amino acid sequence in the sequence listing, SEQ ID NO: 6, 7) DNA coding chimera protein to which added polypeptide having FLAG sequence in the C-terminal of the amino acids from No. 1 to 1036 in amino acid sequence in the sequence listing, SEQ ID NO: 6, and 8) DNA coding chimera protein to which added said Fc sequence in the C-terminal of the amino acids from No. 1 to 1036 in amino acid sequence in the sequence listing, SEQ ID NO: 6, and to have dimer structure by disulfide bond in the hinge region, are ligated individually with the expression vector pMKITNeo to prepare extracellular expression vectors of human Serrate-1. [0070] The full-length expression vectors of the human Serrate-1 as the expression vectors, which express full-length proteins of the human Serrate-1, can be prepared as follows. 9) DNA coding amino acids from No. 1 to 1187 in the sequence listing, SEQ ID NO: 7 and 10) DNA coding chimera protein to which added polypeptide having FLAG sequence in the C-terminal of amino acids from No. 1 to 1187 in the sequence listing, SEQ ID NO: 7 are ligated individually with the expression vector pMKITNeo to prepare the full-length expression vectors of human Serrate-1. The transformant is prepared by using expression plasmid containing DNA coding the thus constructed said human Serrate-1. [0073] Examples of the host are genus Escherichia, genus Bacullus, yeast and animal cells. Examples of animal cells are simian cell COS-7 and Vero, Chinese hamster cell CHO and silk worm cell SF9. [0074] As shown in Example 7, the above expression vectors 1)-10) are transduced individually: the human Delta-1 or human Serrate-1 are expressed in COS-7 cell (obtainable from the Institute of Physical and Chemical Research, Cell Development Bank, RCB0539), and the transformants which were transformed by these expression plasmids, can be obtained. Further, human Delta-1 polypeptide and human Serrate-1 polypeptide can be produced by culturing the transformants under preferable culture condition in medium by known culture method. [0075] As shown in Example 8, human Delta-1 polypeptide and human Serrate-1 polypeptide can be isolated and purified from the above cultured mass, in general, by the following methods. [0076] For extraction of the substance from cultured microbial cells or cells, microbial cells or cells are collected by known method such as centrifugation after the cultivation, suspended in preferable buffer solution, disrupted the microbial cells or cells by means of ultrasonication, lysozyme and/or freeze-thawing and collected crude extract by centrifugation or filtration. The buffer solution may contain protein-denaturing agents such as urea and guanidine hydrochloride or surface active agents such as Triton-X. In case of secretion in the cultured solution, the cultured mass is separated by the known method such as centrifugation to separate from microbial cells or cells and the supernatant solution is collected. [0077] The thus obtained human Delta-1 or human Serrate-1, which are contained in the cell extracts or cell supernatants, can be purified by known protein purification methods. During the purification process, for confirmation of existence of the protein, in case of the fused proteins of the above FLAG and human IgGFc, they can be detected by immunoassay using antibody against known antigen epitope and can be purified. In case of not to express as such the fused protein, the antibody in Example 9 can be used for detection. [0078] Antibodies, which specifically recognize human Delta-1 and human Serrate-1, can be prepared as shown in Example 9. Antibodies can be prepared by the methods described in the reference (Antibodies a laboratory manual, E. Harlow et al., Cold Spring Harbor Laboratory) or recombinant antibodies expressed in cells by using immunoglobulin genes isolated by gene cloning method. The thus prepared antibodies can be used for purification of human Delta-1 and human Serrate-1. The human Delta-1 or human Serrate-1 can be detected and assayed by using antibodies which recognize specifically human Delta-1 or human Serrate-1 as shown in Example 9, and can be used for diagnostic agents for diseases accompanied with abnormal differentiation of cells such as malignant tumors. [0079] More useful purification method is the affinity chromatography using antibody. Antibodies used in this case are antibodies described in Example 9. For fused protein, antibodies against FLAG in the case of FLAG, and protein G or protein A in the case of human IgGFc as shown in Example 8. [0080] Any fused protein other than the protein as shown hereinabove can be used. For example, histidine Tag and myc-tag can be mentioned. Any fused proteins can be prepared by using methods of present day genetic engineering techniques other than the known methods, and peptides of the present invention derived from those fused proteins are in the scope of the present invention. [0081] Physiological functions of the thus purified human Delta-1 and human Serrate-1 proteins can be identified by various assay methods, for example, physiological activity assaying methods using cell lines and animals such as mice and rats, assay methods of intracellular signal transduction based on molecular biological means, binding with Notch receptor etc. [0082] We have observed actions for blood undifferentiated cells by using IgG1 chimera proteins of human Delta-1 and human Serrate-1. [0083] As a result, we have found that, as shown in Example 10, in the umbilical cord blood derived blood undifferentiated cells, in which CD34 positive cell fraction is concentrated, polypeptides of the present invention have suppressive action of colony forming action against blood undifferentiated cells, which shows colony formation in the presence of cytokines. The suppressive action is only observed in the presence of SCF. This kind of effect has never been known. [0084] As shown in Example 11, we have found that a maintenance of colony forming cells is significantly extended by addition of IgG1 chimera protein of human Delta-1 or human Serrate-1 in the long term (8 weeks) liquid culture in the presence of cytokines such as SCF, IL-3, IL-6, GM-CSF and Epo. Further we have found that the polypeptides of the present invention had an action not to suppress growth of the colony forming cells. A cytokine, MIP-1α having migration and differentiation suppressive action of blood cells (Verfaillie et al., J. Exp. Med. 179, 643-649. 1994), has no action for maintaining undifferentiation for blood undifferentiated cells. [0085] Further as shown in Example 12, we have found that as a result of adding IgG1 chimera protein of human Delta-1 or human Serrate-1 to the liquid culture in the presence of cytokines, the human Delta-1 and human Serrate-1 had activities for significantly maintaining LTC-IC (Long-Term Culture-Initiating Cells) number, which is positioned most undifferentiated blood stem cells in the human blood undifferentiated cells. [0086] These results indicate that the human Delta-1 and human Serrate-1 suppress differentiation of blood undifferentiated cells, and these actions spread from blood stem cells to colony forming cells. These physiological actions are essential for in vitro expansion of blood undifferentiated cells. Cells cultured in the medium containing human Delta-1 or human Serrate-1 are efficient in recovery of suppresion of bone marrow after administration of antitumor agents, accordingly in vitro growth of hemopoietic stem cells may be possible if other conditions would be completed. Further pharmaceuticals containing the polypeptide of the present invention have action protection and release of the bone marrow suppressive action, which is observed in adverse effects of antitumor agents. [0087] Suppressive action for differentiation of cells in the undifferentiated cells other than blood cells is expected and stimulating action for tissue regeneration can be expected. [0088] In the pharmaceutical use, polypeptides of the present invention are lyophilized with adding preferable stabilizing agents such as human serum albumin, and is used in dissolved or suspended condition with distilled water for injection when it is in use. For example, preparation for injection or infusion at the concentration of 0.1-1000 μg/ml may be provided. A mixture of the compound of the present invention 1 mg/ml and human serum albumin 1 mg/ml divided in a vial could maintain activity of the said compound for long term. For culturing and activating cells in vitro, lyophilized preparation or liquid preparation of the polypeptide of the present invention are prepared and are added to the medium or immobilized in the vessel for culture. Toxicity of the polypeptide of the present invention was tested. Any polypeptide, 10 mg/kg was administered intraperitoneally in mice, but no death of mice was observed. [0089] In vitro physiological activity of the polypeptide of the present invention can be evaluated by administering to disease model mice or its resembled disease rats or monkeys, and examining recovery of physical and physiological functions and abnormal findings. For example, in case of searching abnormality in relation to hemopoietic cells, bone marrow suppressive model mice are prepared by administering 5-FU series of antitumor agents, and bone marrow cell counts, peripheral blood cell counts and physiological functions are examined in the administered group or the non administered group of mice. Further, in case of searching in vitro cultivation and growth of hemopoietic undifferentiated cells including hemopoietic stem cells, the bone marrow cells of mice are cultured in the groups with or without addition of the compound of the present invention, and the cultured cells are transferred into the lethal dose irradiated mice. Result of recovery is observed with the indications of survival rate and variation of blood counts. These results can be extrapolated to the humans, and accordingly useful effective data for evaluation of the pharmacological activities of the compound of the present invention can be obtained. [0090] Applications of the compound of the present invention for pharmaceuticals include diseases with abnormal differentiation of cells, for example leukemia and malignant tumors. These are cell therapy, which is performed by culturing human derived cells in vitro while maintaining their original functions or adding new functions, and a therapy, which is performed by regenerating without damaging the functions originally existing in the tissues by administering the compound of the present invention under the regeneration after tissue injury. Amount of administration may differ in the type of preparation and ranges from 10 μg/kg to 10 mg/kg. [0091] Further strong physiological activity can be achieved by expression of forming multimer of the polypeptide of the present invention. [0092] As shown in Example 10, since the suppressive action of human Delta-1 and human Serrate-1 is stronger in the IgG chimera protein having dimer structure, a form of stronger physiological activity is preferably expressed in the form of multimer formation. [0093] Human Delta-1 and human Serrate-1 having multimer structure can be produced by a method of expressing chimera protein with human IgG Fc region as described in the example and expressing the multimer having disulfide bond with hinge region of the antibody, or a method expressing chimera protein, in which antibody recognition region is expressed in the C-terminal or N-terminal, and reacting with the polypeptide containing extracellular part of the thus said Delta-1 and Human Serrate-1 and/the antibody which recognize specifically the antibody recognition region in the C-terminal or N-terminal. In the other methods, a method, in which a fused protein expressed with only the hinge region of the antibody and the dimerized by disulfide bond, can be mentioned. The multimer of human Delta-1 and human Serrate-1 having higher specific activity than the dimer can be obtained. The said multimer is constructed by fused protein which is prepared for expressing the peptide in the C-terminal, N-terminal or other region. The protein is prepared in the form of forming disulfide bond without effecting in any activities of the other human Delta-1 or human Serrate-1. The multimer structure can also be expressed by arranging one or more peptide, which is selected from polypeptides containing amino acids sequence of the sequence listing, SEQ ID NO: 2, 3, 5 or 6, with genetic engineering method in series or in parallel. Other known methods for providing multimer structure having diner or higher can be applied. Accordingly, the present invention includes any polypeptides containing amino acid sequences described in the sequence listing, SEQ ID NO: 2, 3, 5 or 6 in the form of dimer or higher more structure prepared by genetic engineering technique. [0094] Further in the other method, multimerization method using chemical cross-linker can be mentioned. For example, dimethylsuberimidate dihydrochloride for cross-linking lysine residue, N-(γ-maleimidebutyryloxy) succinimide for cross-linking thiol group of cysteine residue and glutaraldehyde for cross-linking between amino groups can be mentioned. The multimer with diner or more can be synthesized by applying these cross-linking reactions. Accordingly, the present invention includes any polypeptides containing amino acid sequences described in the sequence listing, SEQ ID NO: 2, 3, 5 or 6 in the form of diner or more structure prepared by chemical cross-linking agents. [0095] In application of medical care in which cells are proliferated and activated in vitro and are returned to the body, human Delta-1 or human Serrate-1 of the form hereinabove can be added directly in the medium, but immobilization can also be made. Immobilization method includes applying amino group or carboxyl group in the peptide, using suitable spacers or the above mentioned cross-linkers, and the polypeptide can be covalently bound to the culture vessels. Accordingly, the present invention includes any polypeptides containing amino acid sequences described in the sequence listing, SEQ ID NO: 2, 3, 5 or 6 in the form of existing on the solid surface. [0096] Since the natural human Delta-1 and human Serrate-1 are cell membrane proteins, differentiation suppressive action in the Examples can be expressed by cocultivating with cells expressing these molecules and blood undifferentiated cells. Consequently, this invention includes cocultivation method with transformed cells by using DNA coding amino acid sequences in the sequence listing, SEQ ID NO: 2-7 and undifferentiated cells. [0097] Expressed cell may be COS-7 cell as shown in Examples, but cells of human origin are preferable, and further expressed cells may be cell line or any of human in vivo blood cells and somatic cells. Consequently, the polypeptide can be expressed in vivo by integrated into vectors for gene therapy. [0098] As shown in Example 10, FLAG chimera protein of human Delta-1 or human Serrate-1, both of which are low concentrated monomer, shows not a colony formation suppressive action but a colony formation stimulating action. This action may be involved in expressing Notch receptor and Notch ligand in the occasion of cell division of blood undifferentiated cells and acting the polypeptide of the present invention as an antagonist for that action. This suggests that the polypeptide having amino acid sequence of the sequence listing, SEQ ID NO: 1, 2, 4 or 5, shows colony formation stimulation action by controlling the concentration of its action. [0099] This fact suggests that inhibition of binding the polypeptide having amino acid sequence in the sequence listing, SEQ ID NO: 2-7 and these receptors can be used for finding out molecules and compounds for stimulating cell differentiation. The methods include binding experiment using radio isotope, luciferase assay using transcriptional control factors, a down stream molecule of the Notch receptor, and simulation on the computer by X-ray structural analysis. Accordingly, the present invention includes screening method for pharmaceuticals using polypeptide in the sequence listing, SEQ ID NO: 2-7. [0100] As shown in Example 13, specific leukemia cells can be differentiated by using IgG chimera protein of human Delta-1 or human Serrate-1. Consequently, the present invention can be applied for diagnostic reagents for leukemia or isolation of specific blood cells. This result indicates that human Delta-1 or human Serrate-1 molecule binds specifically with its receptor, a Notch receptor molecule. For example, expression of Notch receptor can be detected by using fused protein with the above extracellular region and human IgGFc. Notch is known to involve in some type of leukemia (Ellisen et al., Cell 66, 649-661, 1991). Accordingly, the polypeptide having amino acids sequence in the sequence listing. SEQ ID NO: 2, 3, 5 and 6 can be used for diagnostic reagents for in vitro or in vivo. BRIEF EXPLANATION OF THE DRAWINGS [0101] FIG. 1 : Alignment of DSL domain of Notch ligand identified in various organisms including the molecules of the present invention, wherein the consensus sequence is SEQ ID NO: 40, hDelta-1.DSL is SEQ ID NO: 41, dDelta.DSL is SEQ ID NO: 42, xDelta.DSL is SEQ ID NO: 43, cDelta-1.DSL is SEQ ID NO: 44, mDelta-1.DSL is SEQ ID NO: 45, hSerrate-1.DSL is SEQ ID NO: 46, dSerrate.DSL is SEQ ID NO: 47, and rJagged.DSL is SEQ ID NO: 48. [0102] FIGS. 2A and 2B : Suppression of colony formation of the blood undifferentiated cells using the molecules of the present invention. [0103] FIG. 3 : Concentration dependency of colony formation suppression of the blood undifferentiated cells using the molecules of the present invention. [0104] FIG. 4 : A graph showing calculation of LTC-1 after liquid culture using the molecules of the present invention. [0105] FIGS. 5 A and 5 B: Cells stained by the molecules of the present invention. EXAMPLES [0106] Following examples illustrate the embodiments of the present invention but are not construed as limiting these examples. Example 1 [0107] Cloning of PCR Products using Human Delta-1 Primer and Determination of Base Sequence [0108] A mixed primer corresponding to amino acid sequence conserved in C-Delta-1 and X-Delta-1, i.e. sense primer DLTS1 (sequence listing, SEQ ID NO: 14) and antisense primer DLTA2 (sequence listing, SEQ ID NO: 15), were used. [0109] A synthetic oligonucleotide was prepared by using automatic DNA synthesizer with the principle of immobilized method. The automatic DNA synthesizer used was 391PCR-MATE of Applied Biosystems Inc., U.S.A. Nucleotide, carrier immobilized with 3′-nucleotide, solution and reagents are used according to the instructions by the same corporation. Oligonucleotide was isolated from the carrier after finishing the designated coupling reaction and treating the oligonucleotide carrier, from which protective group of 5′-teminal was removed, with concentrated liquid ammonia at room temperature for one hour. For removing the protective groups of nucleic acid and phosphoric acid, the reactant solution containing nucleic acid was allowed to stand in the concentrated ammonium solution in the sealed vial at 55° C. for over 14 hours. Each oligonucleotide, from which the carrier and protective groups were removed, was purified by using OPC cartridge of the Applied Biosystems Inc., and detritylated by using 2% trifluoracetic acid. Primer was dissolved in deionized water to set final concentration of 100 pmol/μl after purification. [0110] Amplification of these primers by PCR was performed as follows. Human fetal brain originated cDNA mixed solution (QUICK-Clone cDNA, CLONTECH Inc., U.S.A.) 1 μl was used. 10× buffer solution [500 mM KCl, 100 mM Tris-HCl (pH 8.3), 15 mM MgCl 2 , 0.01% gelatin] 5 μl, dNTP mixture (Takara Shuzo Co., Japan) 4 μl, sense primer DLTS1 (100 pmol/μl) 5 μl which was specific to the above vertebrates and antisense primer DLTA2 (100 pmol/μl) 5 μl and TaqDNA polymerase (AmpliTaq, Takara Shuzo Co., Japan, 5 U/μl) 0.2 μl were added thereto, and finally deionized water was added to set up total 50 μl, PCR was performed by 5 cycles of a cycle consisting of treatment at 95° C. for 45 seconds, at 42° C. for 45 seconds and 72° C. for 2 minutes, further 35 cycles of a cycle consisting of treatment at 95° C. for 45 seconds, at 50° C. for 45 seconds and 72° C. for 2 minutes, and finally allowed to stand at 72° C. for 7 minutes. A part of the PCR products was subjected to 2% agarose gel electrophoresis, stained with ethidium bromide (Nippon Gene Co., Japan), and observed under ultraviolet light to confirm amplification of about 400 bp DNA. [0111] Total amount of PCR product was subjected to electrophoresis with 2% agarose gel prepared by low melting point agarose (GIBCO BRL Inc., U.S.A.), stained by ethidium bromide, cutting out about 400 bp bands of PCR products by the Delta primer under the UV light, adding distilled water of the same volume of the gel, heating at 65° C. for 10 minutes, and completely dissolving the gel. The dissolved gel was centrifuged at 15000 rpm for 5 minutes to separate supernatant solution after adding equal volume of TE saturated phenol (Nippon Gene Co., Japan) and the same separation operation was performed after adding TE saturated phenol:chloroform (1:1) solution and chloroform. DNA was recovered from the final solution by ethanol precipitation. [0112] A vector, pCRII vector (Invitorogen Inc., U.S.A., hereinafter designates as pCRII) was used. The vector and the above DNA in molar ratio of 1:3 were mixed and DNA was ligated into the vector by using T4 DNA ligase (Invitorogen Inc., U.S.A.). The pCRII, to which DNA was integrated, was subjected to gene transduction into E. coli one shot competent cells (Invitorogen Inc., U.S.A.) and was spread on the semi-solid medium plate of L-Broth (Takara Shuzo Co., Japan) containing ampicillin (Sigma Corp., U.S.A.) 50 μg/ml and allowed to stand at 37° C. for about 12 hours. The resulting colonies were randomly selected, inoculated in the L-Broth liquid medium 2 ml containing same concentration of ampicillin and shake cultured at 37° C. for about 18 hours. The cultured bacterial cells were recovered and the plasmid was separated by using Wizard Miniprep (Promega Inc., U.S.A.) according to the attached explanation sheet. The plasmid was digested by restriction enzyme EcoRI. Integration of the said PCR product was confirmed by incision of about 400 bp DNA. Base sequence of the incorporated DNA in the confirmed clone was determined by the fluorescent DNA sequencer (Model 373S, Applied System Inc., U.S.A.) Example 2 [0113] Cloning of Full Length Novel Human Delta-1 and its Analysis [0114] A screening of clones having full length cDNA was performed by hybridization from human placenta origin cDNA library (inserted cDNA in λgt-11. CLONTECH Inc., U.S.A.) in plaques corresponding to 1×10 6 plaques. Generated plaques were transfered onto nylon filter (Hybond N+: Amersham Inc., U.S.A.). The transcribed nylon filter was subjected to alkaline treatment [allow to stand for 7 minutes on the filter paper permeated with a mixture of 1.5 M NaCl and 0.5 M NaOH], followed by two neutralizing treatments [allow to stand for 3 minutes on the filter paper permeated with a mixture of 1.5 M NaCl, 0.5 M Tris-HCl (pH 7.2) and 1 mM EDTA]. Subsequently, the filter was shaken for 5 minutes in the 2-fold concentrated SSPE solution [0.36 M NaCl, 0.02 M sodium phosphate (pH 7.7) and 2 mM EDTA], washed and air-dried. Then the filter was allowed to stand for 20 minutes on the filter paper, which was permeated with 0.4 M NaOH, shaken for 5 minutes with 5-fold concentrated SSPE solution and washed, then again air-dried. Screening was conducted in the human Delta-1 probe labeled with radioisotope 32 P using these filters. [0115] DNA probe prepared in Example 1 was labeled with 32 P as follows. A DNA fragment was cutted out by EcoRI from pCRII, inserted a purified PCR product (about 400 bp) by human Delta-1 primer and determined gene sequence, and was isolated from low melting point agarose gel. The thus obtained DNA fragment was labeled by DNA labeling kit (Megaprime DNA labeling system: Amersham, U.S.A.). The primer solution 5 μl and deionized water were added to DNA 25 ng to set up total volume of 33 μl, which was treated for 5 minutes in boiling water bath. Reaction buffer solution 10 μl containing dNTP, α- 32 P-dCTP 5 μl and T4 DNA polynucleotide kinase solution 2 μl were added thereto, treated at 37° C. for 10 minutes in water bath. Subsequently, the mixture was purified by Sephadex column (Quick Spin Column Sephadex G-50 Boehringer Mannheim Inc., Germany), then treated for 5 minutes in boiling water bath and ice-cooled for 2 minutes for use. [0116] Hybridization was performed as follows. The prepared filter hereinabove was immersed into the prehybridization solution consisting of SSPE solution, in which final concentration of each component is set at 5-fold concentration, 5-fold concentration of Denhardt's solution (Wako Pure Chemicals, Japan), 0.5% SDS (sodium dodecyl sulfate, Wako Pure Chemicals, Japan) and salmon sperm DNA (Sigma, U.S.A.) 10 μg/ml denatured by boiling water, and shaken at 65° C. for 2 hours, then the filter was immersed into the hybridization solution of the same composition with the above prehybridization solution with the 32 P-labeled probe above mentioned and shaken at 65° C. for 2 hours for 16 hours to perform hybridization. [0117] The filter was immersed into SSPE solution containing 0.1% SDS, shaken at 55° C. and washed twice, further immersed into 10-fold dilution of SSPE solution containing 0.1% SDS and washed four times at 55° C. An autoradiography of the washed filter was performed using intensified screen. Clones of strongly exposed part were collected and the plaques obtained were again spread and screened by the same method hereinbefore to separate complete single clones. [0118] The thus isolated phage clones were seven clones. Phage of all of these clones was prepared to about 1×10 9 pfu, purified the phage DNA, digested by restriction enzyme EcoRI and inserted into pBluescript (Stratagene Inc., U.S.A.) which was digested EcoRI in the same way. DNA sequences of the both ends of these clones were analyzed by DNA sequencer. Three clones of D5, D6 and D7 were the clone containing DNA sequence from No. 1 to 2244 in the sequence listing, SEQ ID NO: 8. A clone D4 was a clone containing DNA sequence from No. 999 to 2663 in the sequence listing, SEQ ID NO: 8. The clones D5 and D4 prepared the deletion mutant by using kilosequence deletion kit (Takara Shuzo Co., Japan) according to a description of the attached paper. Full-length cDNA base sequence of the present invention was determined using the DNA sequencer from both direction of 5′-direction and 3′-direction. [0119] By applying with XhoI site at No. 1214 in DNA sequence in the sequence listing, SEQ ID NO: 8, D4 and D5 were digested by restriction enzyme XhoI to prepare plasmid pBSDel-1 containing full length of DNA sequence in the sequence listing, SEQ ID NO: 8. Example 3 [0120] Cloning of Human Serrate-1 specific PCR Product and Determination of Base Sequence [0121] A mixed primer, which corresponded to amino acid sequence conserved in Drosophila Serrate and rat Jagged, i.e. sense primer SRTS 1 (the sequence listing, SEQ ID NO: 16) and antisense primer SRTA2 (the sequence listing, SEQ ID NO: 17), was used. Preparation was conducted by the same way as described in Example 1. [0122] Amplification by PCR using these primers was performed as follows. To the human fetal brain originated cDNA mixed solution hereinbefore 1 μl was added 10× buffer solution (described in Example 1) 5 μl, said dNTP mixture 4 μl, sense primer SRTS1 (100 pmol/μl) 5 μl and antisense primer SRTA2 (100 pmol/μl) 5 μl specific to Serrate-1 homologue hereinbefore, and said TaqDNA polymerase 0.2 μl, and finally added deionized water to set up total volume 50 μl. The mixture was treated for 5 cycles of a cycle consisting of at 95° C. for 45 seconds, at 42° C. for 45 seconds and 72° C. for 2 minutes, and 35 cycles of a cycle consisting of at 95° C. for 45 seconds, at 50° C. for 45 seconds and 72° C. for 2 minutes, and finally allowed to stand at 72° C. for 7 minutes to perform PCR. A part of the PCR product was subjected to 2% agarose gel elctrophoresis, stained by ethidium bromide, and observed under ultraviolet light to confirm amplification of about 500 bp cDNA. [0123] Total amount of PCR product was subjected to electrophoresis with 2% agarose gel prepared by low melting point agarose, stained by ethidium bromide, cutting out about 500 bp bands under the UV light, adding distilled water of the equal volume of the gel, heating at 65° C. for 10 minutes, and completely dissolving the gel. The dissolved gel was centrifuged at 15000 rpm for 5 minutes to separate supernatant solution after adding equal volume of TE saturated phenol and the same separation operation was performed after adding TE saturated phenol:chloroform (1:1) solution and chloroform. DNA was recovered from the final solution by ethanol precipitation. [0124] A vector, pCRII vector was used. The vector and the above DNA were mixed in molar ratio of 1:3 and DNA fragment was ligated into the vector pCRII by the same method in Example 1. The pCRII, to which DNA was integrated, was subjected to gene transduction into E. coli. The resulting colonies were randomly selected and were inoculated in liquid medium L-Broth 2 ml containing the same concentration of ampicillin and shake cultured at 37° C. for about 18 hours. The cultured bacterial cells were recovered and the plasmid was separated by using the Wizard Miniprep according to the attached explanatory sheet. The plasmid was digested by restriction enzyme EcoRI. Integration of the said PCR product was confirmed by incision of about 500 bp DNA. Base sequence of the incorporated DNA in the confirmed clone was determined by the fluorescent DNA sequencer. Example 4 [0125] Cloning of Full Length Novel Human Serrate-1 and its Analysis [0126] A screening of clones having full length cDNA was performed by hybridization from the human placenta origin cDNA library hereinbefore in plaques corresponding to 1×10 6 plaques. Preparation of the filter was performed by the same method as described in Example 2. Screening was conducted in the human Serrate-1 probe labeled with radioisotope 32 P using the filter. [0127] The above DNA probe labeled with 32 P was prepared by a method described in Example 2, and hybridization, washing of the filter and isolation of the clone were performed by the description in Example 2. [0128] The thus isolated phage clones were 22 clones. Phage of all of these clones was prepared to about 1×10 9 pfu, purified the phage DNA, digested by restriction enzyme EcoRI and inserted into pBluescript which was digested EcoRI in the same way. DNA sequences of the both ends of these clones were analyzed by DNA sequencer. Two clones of S16 and S20 were the clone containing DNA sequence from No. 1 to 1873 in the sequence listing, SEQ ID NO: 10. Two clones S5 and S14 were the clones containing DNA sequence from No. 990 to 4005 in the sequence listing, SEQ ID NO:10. These clones prepared the deletion mutants by using the kilosequence deletion kit according to a description of the attached leaflet. The cDNA base sequence coding the polypeptide of the present invention was determined using the DNA sequencer from both direction of 5′-direction and 3′-direction. [0129] By applying with BglII site at No. 1293 in DNA sequence in the sequence listing, SEQ ID NO: 10.S20 and S5 were digested by restriction enzyme BglII, and DNA of gene sequence from No. 1 to 4005 in the sequence listing SEQ ID NO: 10 was subcloned in E.coli vector pBluescript. This plasmid is named as pBSSRT. [0130] Since the termination codon was not found in the C-terminal and the intracellular region coding C-terminal amino acids was not cloned, cloning of the full length gene was performed using the 3′ RACE system kit, GIBCO-BRL, U.S.A., according to the description of the attached leaflet. The cloning of cDNA gene for 3′-direction was performed in polyA + RNA (CLONTECH Inc., U.S.A.) originated from human placenta to determine the gene sequence. [0131] The thus cloned three gene fragments by applying with BglII site in DNA sequence No. 1293 and AccI site in DNA sequence No. 3943 and a plasmid containing full length of DNA sequence in the sequence listing, SEQ ID NO: 5 were inserted between EcoRI and XbaI in the multi-cloning site of pUC18 to prepare pUCSR-1 containing full length gene of human Serrate-1. This gene sequence as well as its amino acid sequence is shown in the sequence listing, SEQ ID NO: 10. Example 5 [0132] Preparation of Expression Vectors of Human Delta-1 [0133] Using the gene consisting of DNA sequence described in the sequence listing, SEQ ID NO: 7, expression vectors of human Delta-1 protein mentioned in the following 1)-5) were prepared. Addition of restriction enzyme sites and insertion of short gene sequence were performed using ExSite PCR-Based Site-Directed Mutagenesis Kit (Stratagene Inc., U.S.A.) according to the operating manual. [0134] 1) Expression Vector of Soluble Human Delta-1 Protein (HDEX) [0135] The cDNA coding polypeptide of amino acid sequence form No. 1 to 520 in the sequence listing, SEQ ID NO: 3 was ligated with expression vector pMKITNeo containing SRα promoter and neomycin resistance gene to prepare expression vector. [0136] For preparation of expression vector of human Delta-1, in order to stable expression from gene product, EcoRI site was added in the 20 bp upper stream for 5′-direction of the initiation codon (gene sequence No. 179 in the sequence listing, SEQ ID NO: 8). Using the above Mutagenesis Kit, a plasmid pBSDel-1, which contained DNA sequence in sequence listing, SEQ ID NO: 8 and full length cDNA of human Delta-1 were set as the template, and oligonucleotides having gene sequence in sequence listing, SEQ ID NO:18 and SEQ ID NO:19 was set as the primers. Then DNA adding EcoRI site in the 20 bp upper stream for 5′-direction was prepared. Hereinafter this plasmid is designated as pBS/Eco-Delta. [0137] The pBS/Eco-Delta was used as a template. In order to add the termination codon and restriction enzyme MluI site after a C-terminal position, using the Mutagenesis Kit, and setting oligonucleotides having gene sequences in the sequence listing, SEQ ID NO: 20 and SEQ ID NO: 21 as primers, addition of the termination codon and MluI site were performed. The resulted vector was digested by EcoRI and MluI, and about 1600 bp splitted gene fragment was ligated in pMKITNeo, which was treated by the same restriction enzyme, to construct the expression vector. This vector was designated as pHDEX. [0138] 2) Expression Vector of FLAG Chimera Protein of Soluble Human Delta-1 (HDEXFLAG) [0139] The cDNA coding chimera protein, to which cDNA coding FLAG sequence was added to the C-terminal of polypeptide from No. 1 to 520 of amino acid sequence in the sequence listing, SEQ ID NO: 3, was ligated to the expression vector pMKITNeo containing SRα promoter and neomycin resistance gene to prepare the expression vector. [0140] Using pBS/Eco-Delta as template, FLAG sequence was added in the extracellular C-terminal, i.e. after Gly at No. 520 in the sequence listing, SEQ ID NO: 3. In order to add the termination condon and restriction enzyme MluI site, using the Mutagenesis Kit, and setting oligonucleotides having gene sequence in the sequence listing, SEQ ID NO:22 and SEQ ID NO:21 as primers, a gene coding FLAG sequence and termination codon and MluI site were added in the C-terminal. This vector was digested by EcoRI and MluI, and about 1700 bp splitted gene fragment was ligated to the similarly restriction enzyme treated pMKITNeo to construct the expression vector. This vector was designated as pHDEXFLAG. [0141] 3) Expression Vector of IgG1Fc Chimera Protein of Soluble Human Delta-1 (HDEXIg) [0142] A gene sequence coding polypeptide, to which amino acid sequence of Fc region below the hinge part of human IgG1 was added to the C-terminal of polypeptide having amino acid sequence in the sequence listing, SEQ ID NO: 3. [0143] Preparation of fused protein with immunoglobulin Fc protein was performed according to the method of Zettlmeissl et al. (Zettlmeissl et al., DNA cell Biol., 9, 347-354, 1990). A gene using genome DNA with intron was applied and the said gene was prepared by using PCR. Human genome was used as a template. An oligonucleotide of the sequence in the sequence listing, SEQ ID NO: 23 with restriction enzyme BamHI site and an oligonucleotide of the sequence in the sequence listing, SEQ ID NO: 24 with restriction enzyme XbaI site were used as primers. PCR was performed using the primers and human genomic DNA as template. About 1.4 kbp band was purified, treated by restriction enzyme BamHI and XbaI (Takara Shuzo Co., Japan), and genes were ligated to pBluescript, which was similarly treated by restriction enzyme, by using T4 DNA ligase to prepare subcloning. Later, the plasmid DNA was purified and sequenced to confirm gene sequence, then the said gene sequence was confirmed as genomic DNA in the hinge region of heavy chain of the human IgG1. (The sequence is referred to Kabat et al., Sequence of Immunological Interest, NIH Publication No. 91-3242, 1991). Hereinafter this plasmid is designated as pBShIgFc. [0144] Using the said pBS/Eco-Delta as template, and using the Mutagenesis Kit, restriction enzyme BamHI site was added in the extracellular C-terminal, i.e. after Gly at No. 520 in the sequence listing, SEQ ID NO: 3. Furthermore, in order to add restriction enzyme XbaI and MluI sites to the downstream, and setting the oligonucleotides having gene sequence in the sequence listing, SEQ ID NO: 25 and SEQ ID NO: 26. using the Mutagenesis Kit, BamHI, XbaI and MluI sites were added. This vector digested by XbaI and BamHI and about 1200 bp of gene fragment digested from the above pBShIgFc by XbaI and BamHI were ligated to prepare vector containing gene fragments coding the final objective soluble human Delta-1 IgG1Fc chimera protein. Finally, this vector was digested by EcoRI and MluI and about 3000 bp splitted gene fragments were ligated with the similarly restriction enzyme treated pMKITNeo to construct the expression vector. This vector was designated as pHDEXIg. [0145] 4) Expression Vector of Full Length Human Delta-1 Protein (HDF) [0146] The cDNA coding polypeptide from No. 1 to 702 of amino acid sequence in the sequence listing, SEQ ID NO: 4, was ligated to the expression vector pMKITNeo containing SRα promoter and neomycin resistance gene to prepare the expression vector. [0147] In order to add the termination codon in C-terminal of the full length sequence, i.e. after Val at No. 702 in the sequence listing, SEQ ID NO: 4 and restriction enzyme MluI site, using the Mutagenesis Kit and pBS/Eco-Delta as template and setting oligonucleotides having gene sequence in the sequence listing, SEQ ID NO: 27 and SEQ ID NO: 28 as primers, the termination codon and MluI site were added in the C-terminal. This vector was digested by EcoRI and MluI, and about 2200 bp splitted gene fragment was ligated to the similar restriction enzyme treated pMKITNeo to construct the expression vector. This vector was designated as pHDF. [0148] 5) Expression Vector of FLAG Chimera Protein (HDFLAG) of Full Length Human Delta-1 [0149] The cDNA coding chimera protein, to which cDNA coding FLAG sequence was added to the C-terminal of polypeptide from No. 1 to 702 of amino acid sequence in the sequence listing, SEQ ID NO: 4, was ligated to the expression vector pMKITNeo containing SRα promoter and neomycin resistance gene to prepare the expression vector. [0150] In order to add FLAG sequence in the C-terminal, the termination codon and restriction enzyme MluI site, setting oligonucleotides having gene sequence in the sequence listing, SEQ ID NO: 29 and SEQ ID NO: 28 as primers and using pBS/Eco-Delta as template, a gene coding FLAG sequence and termination codon and MluI site were added in the C-terminal. From this vector, DNA coding full length of human Delta-1 was cloned in E. coli vector pUC19 to prepare vector pUCDL-1F coding full length of human Delta-1. This vector was digested by EcoRI and MluI, and about 2200 bp splitted gene fragments were ligated to the similar restriction enzyme treated pMKITNeo to construct the expression vector. This vector was designated as pHDFLAG. Example 6 [0151] Preparation of Expression Vectors of Human Serrate-1 [0152] Using the gene consisting of DNA sequence described in the sequence listing, SEQ ID NO: 10 expression vectors of human Serrate-1 protein mentioned in the following 6)-10) were prepared. Addition of restriction enzyme sites and insertion of short gene sequence were performed by using the ExSite PCR-Based Site-Directed Mutagenesis Kit as well as according to the operating manual. [0153] 6) Expression Vector of Soluble Human Serrate-1 Protein (HSEX) [0154] The cDNA coding polypeptide of amino acid sequence form No. 1 to 1036 in the sequence listing, SEQ ID NO: 6 was ligated with expression vector pMKITNeo to prepare expression vector. [0155] For preparation of expression vector of polypeptide expression cells having amino acid sequence from No. 1 to 1036 in the sequence listing, SEQ ID NO: 6, in order to express gene product more stably EcoRI site was added in the 10 bp upper stream region for 5′-direction of the initiation codon (gene sequence No. 409 in the sequence listing, SEQ ID NO; 10). Using the above Mutagenesis Kit, a plasmid pBSSRT, which contained cDNA of human Serrate-1 from No. 1 to 4005 of DNA sequence in the sequence listing. SEQ ID NO:10, was set as the template, and oligonucleotide having gene sequence in sequence listing, SEQ ID NO: 30 and oligonucleotide having gene sequence in sequence listing, SEQ ID NO: 31 were set as the primers. Then DNA adding EcoRI site in the 10 bp upper stream for 5′-direction was prepared. [0156] The thus prepared vector (hereinafter designates as pBS/Eco-Serrate-1) was used as a template. In order to add the termination codon and further restriction enzyme MluI site in the extracellular C-terminal region, i.e. C-terminal of polypeptide in the sequence listing, SEQ ID NO: 6, using the Mutagenesis Kit, and setting oligonucleotide having gene sequence in the sequence listing, SEQ ID NO: 32 and oligonucleotide having gene sequence in the sequence listing, SEQ ID NO: 33, as primers, the termination codon and MluI site were added. The resulting vector was digested by EcoRI and MluI, and about 3200 bp splitted gene fragment was ligated in pMKITNeo, which was treated by the same restriction enzyme, to construct the expression vector. This vector was designated as pHSEX. [0157] 7) Expression Vector of FLAG Chimera Protein of Soluble Human Serrate-1 (HSEXFLAG) [0158] The cDNA coding FLAG chimera protein, which had FLAG sequence in the C-terminal of polypeptide from No. 1 to 1036 of amino acid sequence in the sequence listing, SEQ ID NO: 6, was ligated to the expression vector pMKITNeo containing SRα promoter and neomycin resistance gene to prepare the expression vector. [0159] Using pBS/Eco-Serrate-1 as a template, FLAG sequence was added in the extracellular C-terminal, i.e. the C-terminal of polypeptide in the sequence listing, SEQ ID NO: 6. In order to add the termination codon and further restriction enzyme MluI site, using the Mutagenesis Kit, and setting oligonucleotide having gene sequence in the sequence listing, SEQ ID NO: 34 and oligonucleotide having gene sequence in the sequence listing, SEQ ID NO: 33 as primers, a gene coding FLAG sequence and termination codon and MluI site were added in the C-terminal. This vector was digested by EcoRI and MluI, and about 3200 bp splitted gene fragment was ligated to the similarly restriction enzyme treated pMKITNeo to construct the exprssion vector. This vector was designated as pHSEXFLAG. [0160] 8) Expression Vector of IgG1Fc Chimera Protein of Soluble Human Serrate-1 (HSEXIg) [0161] A gene sequence coding polypeptide, to which amino acid sequence of Fc region below the hinge part of human IgG1 was added to the C-terminal of polypeptide having amino acid sequence in the sequence listing, SEQ ID NO: 6. [0162] In order to add restriction enzyme BamHI site in the extracellular C-terminal, i.e. after the polypeptide having the sequence in the sequence listing, SEQ ID NO: 6 and further restriction enzyme XbaI and MluI sites to its downstream, BamHI, XbaI and MluI sites were added Using pBS/Eco-Serrate-1 as a template by the Mutagenesis Kit, using oligonucleotide having gene sequence in the sequence listing, SEQ ID NO: 35 and oligonucleotide having gene sequence in the sequence listing, SEQ ID NO: 36 as primers. This vector digested by XbaI and BamHI and about 1200 bp of gene fragment digested from the above pBShIgFc by XbaI and BamHI were ligated to finally prepare a vector, which contained gene fragments coding IgG1Fc chimera protein of the soluble human Serrate-1. Finally, this vector was digested by EcoRI and MluI, and splitted about 4400 bp gene fragment was ligated to pMKITNeo to construct the expression vector. This vector was designated as pHSEXIg. [0163] 9) Expression Vector of Full Length Human Serrate-1 Protein (HSF) [0164] The cDNA coding polypeptide from No. 1 to 1187 of amino acid sequence in the sequence listing, SEQ ID NO: 7 was ligated with expression vector pMKITNeo containing SRα promoter and neomycin resistance gene to prepare expression vector. [0165] For preparation of the full length expression vector about 900 bp splitted gene fragment from pBS/Eco-Serrate-1 digested by restriction enzyme EcoRI and BglII, and pUCSR-1 digested by the same restriction enzyme were ligated, and a vector pUC/Eco-Serrate-1 coding full length gene of human Serrate-1 was prepared. [0166] In order to add the termination codon to the site after Val at No. 1187 in the sequence listing, SEQ ID NO: 7, and further add the restriction enzyme MluI site, using the Mutagenesis Kit, the termination codon and MluI site were added to the C-terminal using oligonucleotides having gene sequence in the sequence listing, SEQ ID NO:37 and SEQ ID NO:38 as primers and the pBS/Eco-Serrate-1 as a template. The resulting vector was digested by EcoRI and MluI, and about 3700 bp splitted gene fragments were ligated in pMKITNeo, which was treated by the same restriction enzyme, to construct the expression vector. This vector was designated as pHSF. [0167] 10) Expression Vector of FLAG Chimera Protein of Full Length Human Serrate-1 (HSFLAG) [0168] The cDNA coding chimera protein, to which cDNA coding FLAG sequence was added in the C-terminal of polypeptide from No. 1 to 1187 of amino acid sequence in the sequence listing, SEQ ID NO: 7, was ligated to the expression vector pMKITNeo containing SRα promoter and neomycin resistance gene to prepare the expression vector. [0169] In order to add FLAG sequence in the C-terminal the termination codon and further restriction enzyme MluI site, setting oligonucleotides having gene sequence in the sequence listing, SEQ ID NO: 39 and SEQ ID NO: 38 as primers, using pBS/Eco-Serrate-1 as a template a gene coding FLAG sequence, the termination codon and the MluI site were added in the C-terminal as same as similar manner. This vector was digested by EcoRI and MluI, and about 3700 bp splitted gene fragments were ligated to the similarly restriction enzyme treated pMKITNeo to construct the expression vector. This vector was designated as pHSFLAG. Example 7 [0170] Expression and Gene Transfer of the Expression Vectors into Cells [0171] The expression vectors prepared in Examples 5 and 6 were transduced into COS-7 cell (obtained from RIKEN Cell Bank, Physical and Chemical Research Institute, Japan, RCB0539). [0172] Cell culture before gene transduction was performed by culturing in D-MEM (Dulbecco modified Eagle's medium, GIBCO-BRL Inc., U.S.A.) 10% FCS. On a day before gene transduction, medium of cells was changed to set cell counts 5×10 5 cells/ml and cultured for overnight. On the day of gene transduction, cells were sedimented by centrifugation, centrifugally washed twice with PBS(−) and prepared the cells to 1×10 7 cells/ml in 1 mM MgCl 2 and PBS(−). Gene transfer was performed by electroporation using gene transduction device Gene-pulsar (Bio-Rad Inc., U.S.A.). The above cell suspension 500 μl was collected in the cell for electroporation (0.4 cm), added expression vector 20 μg, and allowed to stand in ice for 5 minutes. Electroporation was performed under the condition 3 μF, 450 V twice, during the twice electroporation cell mixture was allowed to stand at room temperature. After 5 minutes stayed in ice, cells were spread in the culture medium, diameter 10 cm previously added 10 ml of medium, and cultured at 37° C. in 5% carbon dioxide incubator. [0173] The next day, the culture supernatant solution was removed, washed the cells adhered to the dish twice with PBS(−) 10 ml. In case of expression vector pHDEX, pHDEXFLAG, pHDEXIg, pHSEX, pHSEXFLAG, and pHSEXIg, serum-free D-MEM 10 ml was added and cultured for 7 days. Culture supernatant solution was recovered and was replaced the buffer to PBS(−) by Centricon 30 (Amicon Inc., U.S.A.) and simultaneously the solution was concentrated to 10-fold to obtain cell culture supernatant solution. [0174] In case of pHDF, pHDFLAG, pHSF, and pHSFLAG, medium was changed by D-MEM containing 10% FCS. and cultured-further 3 days to prepare cell lysate. Thus, 2×10 6 cells were suspended in the cell lysis buffer [50 mM Hepes (pH 7.5), 1% Triton X100, 10% glycerol, 4 mM EDTA, 50 μg/ml Aprotinin, 100 μM Leupeptin, 25 μM Pepstatin A and 1 mM PMISF] 200 μl, allowed to stand in ice for 20 minutes and centrifuged at 14000 rpm for 20 minutes to remove supernatant solution to obtain cell lysate. [0175] Expression of Proteins were Detected by Western Blotting. [0176] Concentrated cultured supernatants or cell lysates were subjected to SDS-PAGE using an electrophoresis tank and polyacrylamide gel for SDS-PAGE (gradient gel 5-15%) (ACI Japan Inc., Japan) according to the manufacturer's construction. Samples were prepared by treatment in boiling water for 5 min. with 2-mercaptoethanol (2-ME) for reduction, and non-reduced condition without taking the above treatment. As a marker, Rainbow darker (high molecular weight, Amersham Inc.) was used. Sample buffer solution and electrophoresis buffer were prepared with reference to the attached leaflet. When the SDS-PAGE was finished, acrylamide gel was transcribed to PVDF membrane filter (BioRad Inc., U.S.A.) using the Mini Trans Blot Cell (BioRad Inc.). [0177] The thus prepared filter was shaken overnight at 4° C. in the Blockace (Dainippon Pharm. Co., Japan), TBS-T [20 mM Tris, 137 mM NaCl (pH 7.6) and 0.1% Tween 20] to blocking. According to the explanation of the attached leaflet of ECL Western blotting detection system (Amersham Inc., U.S.A.): in case that the objective protein was human Delta-1 origin, anti-human Delta-1 mouse monoclonal antibody described in Example 9 was used as primary antibody; in case that protein was human Serrate-1 origin, anti-human Serrate-1 mouse monoclonal antibody described in Example 9 was used as primary antibody; and in case that protein was FLAG chimera, anti-FLAG M2 mouse monoclonal antibody (Eastman Kodak, U.S.A.) was used as primary antibody, and peroxidase labeled anti-mouse Ig sheep antibodies (Amersham Inc., U.S.A.) was reacted. In case of IgG chimera, peroxidase labeled anti-human Ig sheep antibodies (Amersham Inc., U.S.A.) was reacted. [0178] Reaction time for antibodies was 1 hour at room temperature, and at an interval of each reaction, washing was performed by shaking in TBS-T at room temperature for 10 minutes for three times. After the final washing, the filter was immersed in the reaction solution of ECL-Western blotting detection system (Amersham Inc., U.S.A.) for 5 minutes, and wrapped in polyvinylidene chloride wrap to expose X-ray film. [0179] As the result, in the sample with treatment of reduction, the bands showing protein obtained by transduction of pHDEX and pHDEXFLAG was detetcd about 65 kD; protein obtained by transduction of pHDEXIg was detected about 95 kD, and protein obtained by transduction of pHDF and pHDFLAG was detected about 85 kD. In the non-reduced sample, the bands showing protein obtained by transduction of pHDEXIg was detected slightly smeared bands at 120 kD to 200 kD, mainly about 180 kD, which showed about 2-fold of the reduction stage, consequently, dimer was formed. [0180] And also, in the sample with treatment of reduction, the bands showing protein obtained by transduction of pHSEX and pHSEXFLAG was detected about 140 kD; protein obtained by transduction of pHSEXIg was detected about 170 kD, and protein obtained by transduction of pHSF and pHSFLAG was detected about 150 kD. In the non-reduced sample, the bands showing protein obtained by transduction of pHSEXIg was detected slightly smeared bands at 250 kD to 400 kD, mainly about 300 kD, which showed about 2-fold of the reduction stage, consequently, dimer was formed. [0181] In these experiments, however cell lysate and cultured supernatant of COS-7 cells, to which pMKITNeo vector was transduced as a control was tested., no bands reacted against anti-human Delta-1 mouse monoclonal antibody, anti-human Serrate-1 mouse monoclonal antibody, anti-FLAG antibody, and anti-human Ig antibody were detected. [0182] Therefore, this ten-expression vector can produce the objective polypeptides. Example 8 [0183] Purification of Soluble Human Delta-1 and Human Serrate-1 Proteins of Gene Transduction Cells [0184] Cultured supernatant of COS-7 cells consisting of HDBXFLAG, HDBXIg, HSEXFLAG and HSEXIg, all of which expression was detected by a method in Example 7, were prepared on large scale, and each chimera protein was purified by affinity column chromatography. [0185] In case of HDEXFLAG and HSEXFLAG, 2 liter of the cultured supernatant obtained by the method in Example 7 was passed through a column packed with Anti-FLAG M2 Affinity Gel (Eastman Kodak, U.S.A.). The chimera protein was adsorbed in a column by a reaction of affinity of anti-FLAG antibody of the gel and FLAG sequence of the chimera protein. Column, inner diameter 10 mm, disposable column (BioRad Inc., U.S.A.) was used with packing the above gel 5 ml. A circulation system consisting of medium bottle→column→peristaltic pump→medium bottle was set up. The circulation was run by a flow 1 ml/min. for 72 hours. Thereafter the column was washed with PBS (−) 35 ml and eluted by 0.5 M Tris-glycine (pH 3.0) 50 ml. The eluate of 25 fractions, each 2 ml, was collected into the tube, and each fraction was neutralized by 200 μl of 0.5 M Tris-HCl (pH 9.5) previously added in each tube. [0186] The eluate fraction, each 10 μl of the secretor FLAG chimera protein which was purified by the above method was subjected to reduction treatment described in Example 7. SDS-PAGE electrophoresis by 5-10% gradient polyacrylamide gel was performed. After finishing the electrophoresis, silver staining was conducted by using Wako silver stain kit It (Wako Pure Chemicals, Japan) according to the explanation of the attached leaflet. Fractions from No. 4 to 8 showed detectable bands in HSFLAG. The size is identical with the result of Western blotting of anti-FLAG antibody obtained in Example 6 in both of HDEXFLAG and HSEXFLAG. Therefore, purified HDEXFLAG and HSEFLAG were obtained. [0187] In the IgG1Fc chimera protein, i.e. HDEXIg and HSEXIg, the cultured supernatant solution 2 liter was adsorbed in Protein A Sepharose colulnn (Pharmacia Inc., Sweden) according to the same method as of FLAG chimera protein to collect the eluate fractions. Using a part of eluate as same as in FLAG chimera protein, a determination of the eluate fraction, identification of the size and detection of the purity were performed by SDS-PAGE electrophoresis and silver staining in the reduced condition. Therefore, the eluate fraction from No. 4 to 15 were the detected bands. The size thereof is identical with the result of Western blotting using anti-human Ig antibody in both of HDEXIg and HSEXIg. Therefore, purified HDEXIg and HSEXIg were obtained. Example 9 [0188] Preparation of Antibodies Recognizing Human Delta-1 and Human Serrate-1 [0189] HDEXFLAG and HSEXFLAG, purified by the method in Example 8, were used as immunogen, and rabbits were immunized. After assaying antibody titer, whole blood was collected and serum was obtained. Anti-human Delta-1 rabbit polyclonal antibody and anti-human Serrate-1 rabbit polyclonal antibody were purified by using the econopack serum IgG purification kit (BioRad Inc., U.S.A.) with reference to the attached explanation leaflet. [0190] HDEXFLAG and HSEXFLAG purified by a method described in Example 8 were used as lmmunogens, and mouse monoclonal antibodies were prepared according to the explanation of the textbook. The purified HDEXFLAG or HSEXFLAG was administered in Balb/c mice (Nippon SLC CO., Japan) separately, 10 μg/mouse, immunized intracutaneously and subcutaneously. After second immunization increased serum titer was confirmed by collecting blood ophthalmologically, the third immunization was performed. Subsequently, the spleen of mice was collected and fused with mouse myeloma cells P3×63Ag8 (ATCC TIB9) using polyethylene glycol. Hybridoma was selected by HAT medium (Immunological and Biological Research Institute, Japan), and the hybridoma strains which produced antibody specifically recognizing extracellular region of human Delta-1 or human Serrate-1 in the medium, were isolated by enzyme immunoassay. The hybridoma strains producing mouse monoclonal antibody, which specifically recognized human Delta-1 or human Serrate-1, were established. [0191] Anti-human Delta-1 monoclonal antibody and anti-human Serrate-1 monoclonal antibody were purified and prepared by using Mab Trap GII (Pharmacia lnc., Sweden) and according to the explanation of the leaflet, from the supernatant of the thus established hybridoma. [0192] Affinity column was prepared by using these monoclonal antibodies. Preparation of the affinity column was performed according to the explanation attached to the CNBr activated Sephadex 4B (Pharmacia Inc., Sweden). A column, 2 cm 2 ×1 cm, containing gel 2 ml, was prepared. [0193] A concentrated solution of the supernatant of the cultured COS-7 cells, to which pHDEX was gene transduced, was passed through the column for which anti-human Delta-1 monoclonal antibody was bound. A concentrated solution of the supernatant of the cultured COS-7 cells, to which pHSEX was gene transduced, was passed through the column, for which anti-human Serrate-1 monoclonal antibody was bound. Each supernatant solution was passed at 20 ml/hr, subsequently PBS (−) 15 ml was passed at the same flow rate and washed the column. Finally, the products were eluted by a mixture of 0.1 M sodium acetate and 0.5 M NaCl (pH 4.0). The eluate, each 1 ml fraction, was collected, and was neutralized by adding 1M Tris-HCl (pH 9.1) 200 μl for each fraction. [0194] SDS-PAGE of each purified protein was conducted under reduced condition according to the method described in Example 8, followed by silver staining and Western blotting to estimate molecular weight. HDEX, about 65 kD, was purified from concentrated supernatant of the cultured COS-7 cells, to which pHDEX was gene transduced, and HDSEX, about 140 kD, was purified from concentrated supernatant of the cultured COS-7 cells, to which pHSEX was gene transduced. Consequently, human Delta-1 and human Serrate-1 can be purified by these affinity columns. Example 10 [0195] Effects of HDEXIg and HSEXIg to Colony Formation of Blood Undifferentiated Cells [0196] In order to observe physiological action of HDEXIg and HSEXIg on blood undifferentiated cells, CD34 positive cells were cultured in the serum-free semi solid medium in the presence of HDEXIg and HSEXIg and known cytokines, and number of colony forming cells were observed. [0197] Human umbilical cord blood or adult human normal bone marrow blood was treated by the silica solution (immunological and Biological Research Institute. Japan) according to the attached explanation leaflet. Thereafter the low density cellular fraction (<1.077 g/ml) was fractionated by densitometric centrifugation of Ficoll pack (Pharmacia Inc., Sweden) to prepare mononuclear cells. CD34 positive cells of human umbilical cord blood or human normal bone marrow blood was isolated from the mononuclear cells. [0198] Separation of CD34 positive cells was performed by using Micro-Selector System (AIS Inc., U.S.A.) or Dynabeads M-450 CD34 and DETACHa-BEADS CD34 (Dynal Inc., Norway) according to attached explanation leaflets. After separation, the purity was measured as follows. Cells were stained by FITC labeled CD34 antibody HPCA2 (Beckton-Deckinson Inc., U.S.A.) and examined by a flow-cytometer (FACSCalibur, Beckton-Deckinson. U.S.A.). Purity above 85% was confirmed for use. [0199] The thus isolated CD34 positive cells were suspended homogeneously to form 400 cells/ml of the medium hereinbelow, and spread in the 35 mm dish (Falcon Inc., U.S.A.), then cultured for 2 weeks in carbon dioxide incubator at 37° C. under 5% carbon dioxide, 5% oxygen, 90% nitrogen and 100% humidity. The formed blood colonies were counted under the invert microscope. [0200] A medium used is α-medium (GIBCO-BRL, U.S.A.), containing 2% deionized bovine serum albumin (BSA. Sigma, U.S.A.). 10 μg/ml human insulin (Sigma, U.S.A.) 200 μg/ml transferrin (Sigma, U.S.A.), 10 −5 M 2-mercaptoethanol (Nakarai Tesk Co., Japan), 160 μg/ml soybean lectin (Sigma. U.S.A.). 96 μg/ml cholesterol (Sigma, U.S.A. ) and 0.9% methylcellulose (Wako Pure Chemicals, Japan). [0201] To the above medium under the following three conditions of cytokines, human Delta-1 extracellular Ig chimera protein (HDEXIg) or human Serrate-1 extracellular Ig chimera protein (HSEXIg) were added to the final concentration of 1 μg/ml. For control, human IgG1 (Ahens Research and Technology Inc., U.S.A.) was added with the same concentration in order to observe effect of IgGFc region. [0202] Conditions of cytokines are as follows. 1: 100 μg/ml, human SCF(Intergen Inc., U.S.A.), 10 ng/ml humnan IL-3 (Intergen Inc., U.S.A.), 100 ng/ml human IL-6 (Intergen Inc., U.S.A.) 2: 100 ng/ml human SCF, 10 ng/ml human IL-3, 4 ng/ml human thrombopoietin (Pepro Tech Inc., U.S.A.) 3: 100 ng/ml human SCF, 10 ng/ml human IL-3, 100 ng/ml human IL-6, 2 U/ml Epo (Chugai Seiyaku Co., Japan) 10 ng/ml human G-CSF (Chugai Seiyaku Co., Japan) [0206] Results are shown in FIG. 2 . In FIG. 2 , A is a case of human Delta-1 extracellular Ig chimera protein (HDEXIg), and B is a case of human Serrate-1 extracellular Ig chimera protein (HSEXIg). For A and B, each different origin human umbilical cord blood CD34 positive cell was used. The vertical axis: number of colonies. White: control, black HDEXIg or HSEXIg. Both HDEXIg and HSEXIg have suppressive action of colony formation. No differences of the activities on the types of colonies were noted. Therefore, the molecular of the present invention has suppressive action for colony formation against colony forming cells of blood undifferentiated cells, i.e. diferentiation-suppressive action. Comparison with or without SCF on the activity indicated that the suppressive action tended to occur only in the presence of SCF. [0207] Dose-dependent manner of the activity was studied. Comparison with dimer HSEXIg and monomer HSEXFLAG was performed. Result is shown in FIG. 3 . Concentration in this case is indicated as molar concentration. For comparison with dimer and monomer, dimer HSEXIg was indicated by exact two molar concentrations, and was plotted equivalent molar concentration of the human Serrate-1. Vertical axis indicates colony forming counts and horizontal axis indicates molar concentration. Colony forming counts without Notch ligand were plotted on the vertical axis in the zero concentration. For comparison, colony forming counts of human IgG1 1 μg/ml, was about 100 colonies. [0208] This result indicated that HSEXIg and HSEXFLAG suppressed colony formation in dose-dependent manner. Activity of dimer HSEXIg was stronger than the monomer. A monomer HSEXFLAG showed stimulative action for colony formation in the low concentration area. Example 11 [0209] Actions of HDEXIg and HSEXIg on Long Term Liquid Culture of Colony Forming Blood Undifferentiated Cells [0210] For observing physiological action of HDEXIg and HSEXIg on the blood undifferentiated cells, umbilical cord blood CD34 positive cells were culture for long term in the serum-free liquid medium in the presence of HDEXIg or HSEXIg and known cytokines, and numbers of colony forming cells were observed. [0211] The umbilical cord blood mononuclear CD34 positive cells separated by a method described in Example 10 were liquid cultured at 1000 cells/well in the 24 well cell culture plate (Falcon Inc., U.S.A.). Culture was performed at 37° C. in the carbon dioxide incubator under 5% carbon dioxide and 100% humidity. Liquid culture medium was Iscove's modified Dulbecco's medium (IMDM, GIBCO-BRL, U.S.A.) added with 2% BSA, 10 μg/ml human insulin, 200 μg/ml transferrin, 40 μg/ml low density lipoprotein (GIBCO-BRL, U.S.A.), 10 −5 M 2-mercaptoethanol, 50 ng/ml human SCF, 5 ng/ml human IL-3, 10 ng/ml human IL-6, 5 ng/ml human GM-CSF (Intergen Inc., U.S.A.), and 3 U/ml Epo. If necessary, XDEXIg-500 ng HSEXIg or 50 ng/ml MIP-1α (Intergen Inc., U.S.A.) was added. The medium was added 1 ml/well and half of the medium was changed three times in a week. After culturing 2, 4, 6 and 8 weeks, all cells were collected from wells by using cell scraper in 1.5 ml micro tube. Cells were precipitated by centrifugation and resuspended in a fresh [MDM 1 ml, counted the cell counts by using hemocytometer, and in 5000 cells/ml, blood cell colony forming assay was performed. [0212] Blood cell colony forming assay was performed using the lscove's methylcellulose complete ready mix (Stem Cell Technologies Inc., Canada), and each 1 ml was inoculated in two plates of 35 mm dish (Falcon Inc., U.S.A.) and incubated for 2 weeks in the carbon dioxide incubator. Blood colonies were counted CFU-GM and BFU-E in the invert microscope, and total was counted as CFU-C. CFU-C counts and cell counts obtained by hemocytometer were multiplied to obtain CFU-C count/1000 cells inoculated in the liquid culture. [0213] In Table 1, result of HDEXIg and in Table 2. result of HSEXIg are shown. Experiments were conducted at n=3, values obtained were shown by (mean±SD). In the table, ND means no detection of colony. TABLE 1 Colony forming cell maintenance action in the long-term liquid culture of human Delta-1 of the present invention Cytokines Week — MIP-1 α HDEXIg 0 69 ± 9 68 ± 9 68 ± 9 2 1440 ± 120  720 ± 110 1280 ± 230 4 340 ± 40 420 ± 80 410 ± 90 6 28 ± 6  96 ± 17 290 ± 60 8 ND ND  88 ± 13 [0214] TABLE 2 Colony forming cell maintenance action in the long-term liquid culture of human Serrate-1 of the present invention Cytokines Week — MIP-1 α HSEXIg 0 68 ± 9 68 ± 9 68 ± 9 2 1440 ± 120  720 ± 110 1360 ± 280 4 340 ± 40 420 ± 80 560 ± 70 6 28 ± 6  96 ± 17 220 ± 50 8 ND ND 130 ± 50 [0215] CFU-C could only be observed until 6 th week of cultivation under the condition without cytokines for maintaining undifferentiated condition, and under the condition with MIP-1α. lt could be observed at 8 th week in the presence of HDEXIg or HSEXIg. In comparison with MIP-1α and HDEXIg and HSEXIg. MIP-1α strongly suppressed colony formation at 2 weeks of culture, however no suppression in HDEXIg and HSEXIg were observed. In maintenance of CFU-C counts at 6 and 8 weeks of culture, HDBXIg and HSEXIg were superior. Example 12 [0216] Effects of HDEXIg and HSEXIg on Liquid Culture of Blood Undifferentiated Cell LTC-IC [0217] In order to observing physiological action of HDEXIg and HSEXIg on the blood undifferentiated cells, umbilical cord blood CD34 positive cells were cultured for two weeks in the serum-free liquid medium in the presence of HDEXIg or HSEX1g and known cytokines, and numbers of LTC-IC, which was thought to be most undifferentiated blood cells at present were observed. [0218] The umbilical cord blood monocyte CD34 positive cells, 100000 to 20000 cells, separated by a method described in Example 10 were cultured in the following medium for 2 weeks. Numbers of LTC-IC in 4 experimental groups, which include a group before cultivation, a group of HDEXIg, a group of HSEXIg and a control group, were determined. Media used in liquid culture medium were a—medium added with 2% BSA, 10 μg/ml human insulin, 200 μg/ml transferrin, 40 μg/ml low density lipoprotein, and 10 −5 M 2-mercaptoethanol, further added with 100 ng/ml human SCF, 10 ng/ml human IL-3, and 100 ng/ml human IL-6. HDEXIg or HSEXIg 1 μg/ml were added to the above medium. In the control group, human IgG1 was added in the equal concentration. [0219] Preparation of human bone marrow stromal cell layer used for LTC-IC, and quantitative assay of frequency of LTC-IC by a limit dilution were performed according to a method of Sutherland et al. (Blood, 74, 1563-, 1989 and Proc, Natl. Acad. Sci, USA, 87, 3584-, 1990). [0220] The bone marrow mononuclear cells, 1-2×10 7 cells, obtained in Example 10 before the separation and without the silica solution treatment, were cultured in LTC medium (MyeloCul, Stem Cell Technologies Inc., Canada) 5 ml added with hydrocortisone 1 μM (Upjohn Japan Co., Japan) in T-25 flask (Falcon Inc., U.S.A. ) at 37° C. under 5% carbon dioxide and 100% humidity in the carbon dioxide incubator. Culture was conducted until the adhesive cell layers of the stromal cell formation spread more than 80% of the bottom area of the culture. Detachment of the cell layer was performed by treating with EDTA solution (Cosmobio Co., Japan). Cells were plated in the 96 well plate (Beckton-Deckinson Inc., U.S.A.), about 2×10 4 cells/well and re-cultivation was continued in the same medium. X-ray, 15Gy, 250 KV peak was irradiated after reconstituted stromal cell layer. Growth of stromal cells was stopped and blood cells in the stromal cells were removed by this treatment. The thus prepared stromal cells were used as stromal cell layer for the experiments. [0221] In the assay of LTC-IC, cell counts in each group were adjusted within the ranges of 25-400 cells/well for CD34 positive cells before the cultivation, and 625-20000 cells/well for the cells after the cultivation, and cells were diluted for six step-dilution within these ranges. Each dilution step of cells was co-cultured with the above stromal cell layer in the 96 well plate, for 16 wells/cells of one dilution step. Culture was performed in the same medium as used in stromal formation, at 37° C. under 5% carbon dioxide and 100% humidity in the carbon dioxide gas incubator for 5 weeks. Cells in suspension and in attachment after cultivation were recovered in each well. Collected cells were transferred to the semi-solid culture medium consisting of α-medium added with 0.9% methylcellulose, 30% fetal calf serum (FCS, ICN Biomedical Japan), 1% BSA, 10 −5 M 2-mercaptoethanol, 100 ng/ml human SCF, 10 ng/ml human IL-3, 100 ng/ml human [L-6, 2 U/ml Epo and 10 ng/ml human G-CSF. After 2 weeks of cultivation, colony forming cells were detected as the same was as described in Example 10 and 11, and numbers of well, in which colony forming cells were found, were detected. Incidence of LTC-IC was calculated according to the method of Taswell et al. (J. lmmunol. 126, 1614-, 1981) based on the above data. [0222] Graph used for calculation is shown in FIG. 4 . In FIG. 4 , calculation curves after liquid culture is shown. A vertical axis shows ratio of well for no colonies were observed, and a horizontal axis shows number of cells/well. In each experimental group, numbers of well, for which colonies were not observed, and numbers of cells were plotted, then regression curve was calculated by the least square method. Number of cells corresponding to number of 0.37 (a reciprocal of a base of natural logarithm) for which colonies did not appeared, was calculated. A reciprocal of that number of cells is a frequency of LTC-IC. Further, absolute number of LTC-IC was calculated from initial number of cells and frequency of LTC-IC. [0223] The result indicated that 243 LTC-IC were found in 25000 cells before the liquid culture. In the control group number of cells during 2 weeks of cultivation increased to 1,510,000 cells, and LTC-IC was decreased to 49 cells. However, culturing with human Delta-1, i.e. HDEXIg or human Serrate-1, i.e. HSEXIg, numbers of cells were maintained in 1,310,000 and 1,140,000, respectively, and numbers of LTC-IC were slightly decreased to 115 and 53. Consequently, polypeptide of the present invention, especially human Delta-1 could have an activity for maintenance of number of LTC-IC in the liquid culture. Example 13 [0224] Binding of HDEXIg and HSEXIg for Blood Cells [0225] Binding of Notch ligands with various blood cells was studied using specific binding of Notch ligands to Notch receptors. [0226] Blood cell lines tested were Jurkat (ATCC TIB-152), Namalwa (ATCC CRL-1432), HL-60 (ATCC CRL-1964), K562 (ATCC CCL-243), THO-1 (ATCC TIB-2 02), UT-7 (Komatsu et al., Cancer Res., 51, 341-348. 1991), Mo7e (Avanzi et al. Br. J.Haematol., 69, 359-, 1988) and CMK (Sato et al. Exp. Hematol., 15, 495-502, 1987). Culturing media for these cells were found in the reference or ATCC CELL LIMES & HYBRIDOMAS, 8 th Ed. (1994). [0227] Cells, 1×10 6 cells, were suspended in Hank's balanced salt solution containing 2% FCS and 10 mM Hepes. HDEXlg or HSEXIg 1 μg/ml were added therein and allowed to stand at 4° C. for overnight. Cells were washed twice with the Hank's solution. PE labeled sheep anti-human IgG monoclonal antibody 1 μg/ml was added, allow to stand in ice-cooling for 30 minutes, washed twice with the Hank's solution, and suspended in the Hank's solution 1 ml. Analysis was performed using the flow cytometer (FACSCalibur). Control groups were used with human IgG1 staining in place of HDEXIg or HSEXIg staining. [0228] Results are shown in FIG. 5 . A vertical axis indicates cell counts and a horizontal axis indicates fluorescence intensity. Staining with HDEXIg or HSEXIg is shown by solid line and control, a staining with human IgG1 is shown by a broken line. In FIG. 5 , the left column shows HDEXIg and the right column shows HSEXIg. As shown in FIG. 5 , results indicate that Jurkat: reacted, Namalwa: non-reacted, HL-60: non-reacted, K562: non-reacted, THP-1: non-reacted, UT-7: reacted, Mo7e: non-reacted and CMK: reacted. Since the same results in HDEXIg and HSEXIg were obtained, both recognized the identical molecule and these cells can be differentiated. [0000] Effect of the Invention [0229] Notch ligand molecules of the present invention can be used for maintenance of undifferentiated-suppressive substances, and in the preparation of pharmaceuticals.

A polypeptide which contains the amino acid sequence described in SEQ ID NO: 1 in the Sequence Listing encoded by a gene originating in human being. Because of serving as a chemical efficacious in the suppression of the proliferation and differentiation of undifferentiated blood cells, this polypeptide is expected to be usable in medicines and medical supplies.

This application is a continuation of now abandoned application Ser. No. 08/229,767, filed Apr. 19, 1994. FIELD OF THE INVENTION The present invention relates to an aqueous agent containing at least one arginine amide selected from (2R,4R)-4-methyl-1-[N 2 -((RS)-3-methyl-1,2,3,4-tetrahydro-8-quinolinesulfonyl)-L-arginyl]-2-piperidinecarboxylic acid, monohydrate thereof and pharmacologically acceptable salts thereof, which is useful as an active ingredient for inhibiting formation of fibrin in, for example, an entoptic operation, wherein the effective utility of arginine amide as a medicament has been improved. More specifically, the present invention relates to an aqueous composition wherein an arginine amide shows an improved solubility and to an aqueous composition wherein an arginine amide shows an improved stability. Further, the present invention relates to a method for improving the effective utility of arginine amide as a medicament, particularly to a method for improving the solubility of arginine amide and a method for improving the stability thereof. BACKGROUND OF THE INVENTION Conventionally, steroid or indomethacin is administered after an entoptic operation of cataract, corpus vitreum, glaucoma or the like, for the reason that fibrin is formed with considerable frequency to cause postoperative complications. However, administration of said compounds for a few weeks after the operation has not shown dependable effects, but causes, though not often, delay in healing of wounds or disorders in cornea. Fibrin is formed from fibrinogen by the cleavage of arginine-glycoside linkage of fibrinogen by thrombin. Since the aforementioned arginine amide has a potent selective antithrombin action (Japanese Patent Publication No. 48829/1986), the compound is expected to be useful as an eye drop or entoptic perfusate to inhibit formation of fibrin in an entoptic operation. Taking one of the aforementioned arginine amides, (2R,4R)4-methyl-1-[N 2 -((RS)-3-methyl-1,2,3,4-tetrahydro-8-quinolinesulfonyl)-L-arginyl]-2-piperidinecarboxylic acid monohydrate (generally called argatroban) as an example, it is used at a concentration of 1 mg/ml or above as an eye drop or entoptic perfusate for the above-mentioned purpose. Said argatroban has an extremely low solubility in water, showing about 0.9 mg/ml of solubility at 25° C. in the pH range (7.2-7.8) preferable for the administration to local eye sites. Hence, it is necessary to improve the solubility and, as a consequence, the usefulness of argatroban as a medicament. While an aqueous solution of argatroban can be preserved stably in a brown bottle, an improved stability thereof will result in a still greater utility of argatroban as a medicament. Heretofore, arginine amides are known to be dissolved by a method including addition of sugar and alcohol (U.S. Pat. No. 5,214,052). In view of the extremely high sensitivity to irritation that the local eye sites such as cornea exhibit, such method of adding sugar and alcohol is not desirable, since sugar and alcohol per se are irritant to the eye and these compounds are added in greater amounts. Consequently, there is practically no aqueous agent satisfactory as an eye drop or an entoptic perfusate containing arginine amide, particularly argatroban. An object of the present invention is to provide an aqueous agent containing arginine amide improved in the effective utility as a medicament, particularly an aqueous agent of arginine amide having an improved solubility and an aqueous agent of arginine amide showing an improved stability. Another object of the present invention is to provide a method for improving the effective utility of arginine amide as a medicament in an aqueous agent thereof, specifically a method for improving the solubility of arginine amide and a method for achieving a high stability thereof. SUMMARY OF THE INVENTION It has now been found that cyclodextrin or caffeine remarkably improves the solubility of arginine amide, particularly argatroban, in water even with a small amount thereof, that caffeine remarkably improves stability of arginine amide, particularly argatroban, against light in water even with a small amount thereof, and that an aqueous agent containing an arginine amide added with caffeine and/or cyclodextrin causes less eye irritation. Accordingly, the present invention provides an aqueous agent comprising at least one arginine amide selected from the group consisting of (2R,4R)-4-methyl-1-[N 2 -((RS)-3-methyl1,2,3,4-tetrahydro-8-quinolinesulfonyl)-L-arginyl]-2-piperidinecarboxylic acid of the formula ##STR1## monohydrate thereof and pharmacologically acceptable salts thereof, and at least one compound selected from cyclodextrin and caffeine. Also, the present invention provides a method for improving the solubility of arginine amide in water, comprising adding at least one compound selected from the group consisting of cyclodextrin and caffeine. Furthermore, the present invention provides a method for stabilizing arginine amide in water, comprising adding caffeine. DETAILED DESCRIPTION OF THE INVENTION The pharmacologically acceptable salts of arginine amide to be used in the present invention are salts with inorganic acid such as hydrochloride, sulfate, hydrobromide and phosphate; salts with organic acid such as fumarate, tartrate, succinate, citrate and methanesulfonate; alkali metal salts such as sodium salt and potassium salt; alkaline earth salts such as calcium salt; and other salts such as ammonium salt. The preferable arginine amide is argatroban. The aqueous composition of the present invention is preferably used as an eye drop or an entoptic perfusate, In the present invention, improvement in the solubility of arginine amide in water is achieved by adding at least one compound selected from cyclodextrin and caffeine. So as to improve the stability of arginine amide in water, caffeine is added in the present invention. The aqueous composition of the present invention can be obtained by dissolving arginine amide and the aforementioned compound(s) in water. When using as an eye drop, the arginine amide is contained in the aqueous composition of the present invention generally at a concentration of about 0.01(W/V) %-1 (W/V) %, preferably about 0.05 (W/V) %-0.5 (W/V) % and when using as an entoptic perfusate, it is contained generally at a concentration of about 0.0001 (W/V) %-1 (W/V) %, preferably about 0.001 (W/V) %-0.5 (W/V) %. The cyclodextrin to be used in the present invention may be α-compound, β-compound or γ-compound with preference given to β-compound. The cyclodextrin is generally added at a concentration of 0.01-20 (W/V) %, preferably about 0.05-10 (W/V) %, with variation depending on the kind of cyclodextrin to be used in the present invention. The caffeine is added at a concentration of 0.01-3.0 (W/V) %, preferably about 0.05-2.0 (W/V) %. When added in the specified amounts, the solubility and stability of arginine amide are improved. The aqueous composition of the present invention may contain the following various additives usable for aqueous agents, particularly for eye drop and entoptic perfusate. As a buffer, usable are, for example, phosphate buffer, borate buffer, citrate buffer, tartrate buffer, acetate buffer and amino acid. As an isotonizing agent, usable are, for example, sugars such as sorbitol, glucose and mannitol, polyhydric alcohols such as glycerine and propylene glycol, and salts such as sodium chloride. As an antiseptic, usable are, for example, quaternary ammonium salts such as benzalkonium chloride and benzethonium chloride, p-oxybenzoic acid esters such as methyl p-oxybenzoate and ethyl p-oxybenzoate, benzyl alcohol, phenethyl alcohol and sorbic acid and salts thereof, thimerosal and chlorobutanol. As a thickener, usable are, for example, hydroxyethyl cellulose, hydroxypropyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose and salts thereof. When the aqueous composition of the present invention is used as an eye drop, the pH thereof is generally about 3-9, preferably about 4-8 and when used as an entoptic perfusate, the pH thereof is generally about 6-8.5, preferably about 7-8. While the method for producing an aqueous agent of the present invention differs depending on the kind of the agent methods known per se can be used for each liquid agent. The present invention is described in further detail by the illustration of examples and reference example. EXAMPLE 1 Solubility Test The solubility of argatroban in water was determined by the use of various compounds. An excess amount of argatroban was added to a phosphate buffer (pH 7.0) containing a compound at a concentration of 1.0 W/V % and the mixture was shaken at 25° C. for 12 hours. The amount of the argatroban dissolved in this solution was measured by HPLC to determine the solubility. The results are shown in Table 1. TABLE 1______________________________________Compound Amount added (W/V %) Solubility (%)______________________________________Not added -- 0.0930α-cyclodextrin 1.0 0.1340β-cyclodextrin 1.0 0.2590γ-cyclodextrin 1.0 0.1324caffeine 1.0 0.2001______________________________________ As is evident from the results in Table 1, α-cyclodextrin, β-cyclodextrin, γ-cyclodextrin and caffeine showed superior improvement in solubility. In particular, β-cyclodextrin afforded about thrice and caffeine afforded about twice the solubility of argatroban obtained when no compound was added. Reference Example 1 to be mentioned later clearly indicates that fibrin formation was inhibited by about 50% by the argatroban concentration of 0.1 W/V % and fibrin formation was completely inhibited by the argatroban concentration of 0.2 W/V %. It should be understood that the addition of cyclodextrin and/or caffeine, particularly caffeine and β-cyclodextrin, contributes to the clinically effective concentration of argatroban. Eye irritation caused by the respective, aforementioned solutions of α-cyclodextrin, β-cyclodextrin, γ-cyclodextrin and caffeine was examined using house rabbits. As a result, there was found no specific problems, thus showing no harmful effect on the eye tissue. Based on the test results given above, it was found that the use of cyclodextrin and/or caffeine was conducive to the remarkably notable improvement in solubility. EXAMPLE 2 Stability Test Aqueous solutions (pH 7) containing 0.05 W/V % or 0.1 W/V % argatroban and having the formulations 1-6 shown in Table 2 below were filled in glass ampoules and preserved in shade or under light exposure of 600,000 lux per hour. Each solution was examined for pH, appearance, insoluble matter and residual content of argatroban. The results are shown in Table 3. TABLE 2______________________________________ Formu- Formu- Formu-0.05 W/V % argatroban lation lation lationaqueous solution 1 2 3______________________________________Argatroban 0.05% 0.05% 0.05%Caffeine -- 0.25% 0.5%Sodium 0.1% 0.1% 0.1%dihydrogenphosphate Formu- Formu- Formu-0.1% argatroban lation lation lationaqueous solution 4 5 6______________________________________Argatroban 0.1% 0.1% 0.1%Caffeine -- 0.5% 1.0%Sodium 0.1% 0.1% 0.1%dihydrogenphosphate______________________________________ Note: % = W/V % TABLE 3______________________________________Stability of aqueous solution of argatroban (pH 7) against light Residual Appearance pH content (%)______________________________________Formulation 1(shading) colorless and clear 7.05 100(exposed to light) light brown and 6.83 32.1 slightly turbidFormulation 2(shading) colorless and clear 7.04 100(exposed to light) light brown and 6.93 73.6 slightly turbidFormulation 3(shading) colorless and clear 7.08 100(exposed to light) light brown and 7.01 78.7 slightly turbidFormulation 4(shading) colorless and clear 7.00 100(exposed to light) light brown and 6.88 66.3 slightly turbidFormulation 5(shading) colorless and clear 7.00 100(exposed to light) light brown and 6.97 82.1 slightly turbidFormulation 6(shading) colorless and clear 7.00 100(exposed to light) light brown and 6.99 87.6 slightly turbid______________________________________ As is evident from the results in Table 3, the stability of argatroban against light was improved by caffeine. Reference Example--Argatroban concentration and inhibition of fibrin formation in anterior sac Animal used: 18 colored house rabbits weighing 2 kg and showing no abnormality in the eyes by visual observation Drug used: test drug (a solution of argatroban at a concentration of 0.1 W/V % or 0.2 W/V % prepared according to the eye drop of Example 1) : control (physiological saline) Test: Fibrin was formed in anterior sac by irradiation at four sites in iris with argon laser (AC-3500, Nidek). The irradiation was conducted at a spot size of 100 μm, time 0.2 sec and output 1 watt. The fibrin in anterior sac was evaluated according to the evaluation criteria given below for the visual observation with time with a slit lamp after the irradiation up to 3 hours thereafter. The test drug argatroban was administered 7 times by installation of 50 μl of the drug to one of the eyes every 10 minutes beginning from 30 minutes before the laser irradiation to 30 minutes after the irradiation, and physiological saline was administered to the other eye. Slit lamp observation: The presence of fibrin at the 4 sites irradiated with laser was graded (0 or 1). When the fibrin amount was great, the grade was doubled. The fibrin in pupil region was graded in five stages of from 0 to 4 points. The full mark was; irradiation site: 4 points×2+pupil region: 4 points=12 points. Test Results The fibrin amount in anterior sac in the control group reached maximum at 0.5 hour after the laser irradiation and fibrin disappeared with time in 1 hour. The test drug at a concentration of 0.1 W/V % significantly inhibited the fibrin formation at every measurement point. The percent inhibition was about 50%. The test drug completely inhibited the fibrin formation at a concentration of 0.2 W/V %. Formulation Example 1--eye drop An eye drop was prepared according to the following formulation. ______________________________________Argatroban 0.2 gCaffeine 0.5 gPolysorbate 80 0.1 gBenzalconium chloride 0.01 gSodium dihydrogenphosphate 0.1 gSodium chloride 0.8 g1 N Hydrochloric acid 1 mlSodium hydroxide appropriate amountSterile purified water appropriate amountTotal 100 ml (pH 7)______________________________________ Formlation Example 2--eye drop An eye drop was prepared according to the following formulation. ______________________________________Argatroban 0.2 gβ-cyclodextrin 1.0 gBoric acid 1.8 gSodium tetraborate 0.5 gSodium hydroxide appropriate amountSterile purified water appropriate amountTotal 100 ml (pH 7)______________________________________ Formulation Example 3--entoptic perfusate An entoptic perfusate was prepared according to the following formulation. ______________________________________Argatroban 0.15 gGlucose 0.15 gCaffeine 0.5 gSodium chloride 0.6 gPotassium chloride 0.05 gCalcium chloride 0.02 gMagnesium sulfate 0.03 gSodium hydrogencarbonate 0.2 gHydrochloric acid appropriate amountSterile purified water appropriate amountTotal 100 ml (pH 7.5)______________________________________ According to the aqueous agent of the present invention, the solubility of arginine amide in water can be enhanced by the use of at least one compound selected from cyclodextrin and caffeine. Accordingly, the concentration thereof can be increased to, for example, a concentration permitting inhibition of fibrin formation at the time of entoptic operation. In addition, the use of caffeine with arginine amide results in enhanced stability of arginine amide against light. Consequently, the effective utility of arginine amide as a medicament can be enhanced by the present invention.

An aqueous agent comprising at least one arginine amide selected from the group consisting of (2R,4R)-4-methyl-1-[N 2 -((RS)-3-methyl-1,2,3,4-tetrahydro-8-quinolinesulfonyl)-L-arginyl]-2-piperidinecarboxylic acid, monohydrate thereof and pharmacologically acceptable salts thereof, and at least one compound selected from the group consisting of cyclodextrin and caffeine; a method for improving the solubility of arginine amide in water, comprising adding at least one compound selected from the group consisting of cyclodextrin and caffeine; and a method for stabilizing arginine amide in water, comprising adding caffeine. According to the present invention, the solubility of arginine amide in water can be enhanced to, for example, a concentration permitting inhibition of fibrin formation at the time of entoptic operation. In addition, the stability of arginine amide in water can be enhanced with less irritation of the eye.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims priority to German Patent Application No. 10164756.5 filed Dec. 19, 2001, which application is herein expressly incorporated by reference. BACKGROUND AND SUMMARY [0002] The invention relates to a waste holding tank for a sanitary toilet system, in particular, a mobile sanitary toilet system, the toilet system comprising a base section, a bowl section supported by the base section and a waste holding tank, the tank comprising a housing, the housing defining a tank interior and a tank exterior and comprising a vent opening at a first location of the housing, the opening forming a fluid communication between the interior and the exterior of the tank. [0003] Furthermore, the invention relates to a sanitary toilet system, in particular, a mobile sanitary toilet system comprising a base section, a bowl section supported by the base section and a waste holding tank. [0004] Mobile toilet systems of the kind as mentioned above are used in vehicles, e.g. mobile homes, caravans, boats, coaches etc. In such vehicles attempts have been made in the past to reduce the irritation by odors resulting from the formation of bacteria in the waste holding tank by using chemicals. Despite these endeavors, there is generally, and particularly strongly on hot summer days, a very strong and unpleasant irritation due to odors. [0005] An improved venting system for a mobile toilet system is disclosed in DE 199 25 898 A1. To overcome the problems indicated above, it is proposed to connect the vent opening with a suction device when the tank is inserted in the mobile toilet system. Since the vent opening of commonly used tanks is located on the top side of the tank, a conduit is required to connect the vent opening and the suction device leading through a side wall of the base and also through a sidewall of the vehicle. This individually required adaptation of the mobile toilet system to different vehicle situations involves intensive installation efforts with respect to cost and time. [0006] Therefore, it is an object of the present invention to provide a waste holding tank for a mobile toilet system and a mobile toilet having an improved and easily installable venting system. [0007] This object is accomplished in accordance with the invention in a waste holding tank of the type described at the outset in that a vent conduit is provided for connecting the vent opening on the tank exterior at the first location with the exterior of the tank at a second location of the housing, the vent conduit leading at least partly through the interior of the tank without being in fluid communication with the interior of the tank. [0008] The advantage of the inventive solution is that no additional installation work is required for a perfect venting of the tank. The foul gases can easily be led through the vent opening and through the vent conduit to the second location on the exterior of the tank, e.g., on a side wall or the bottom side of the tank. If the tank is inserted into the mobile toilet system, the vent conduit according to the present invention forms a shortcut for the foul gases from the interior of the tank to the exterior at the second location where the tank could easily be connected with the outside of the vehicle, with or without an optional suction device. If the conduit leads at least partly through the interior of the tank, the conduit could be formed partly by the tank itself and partly by a second member, e.g., a part of the base section forming another part of the vent conduit. Such a construction would allow the foul gases to be led along the exterior of the tank to a location where the vent conduit could easily be connected with the exterior of the vehicle and/or the exterior of the room where the toilet system is located. [0009] In a preferred embodiment of the invention, it is provided that the vent conduit leads completely through the interior of the tank. Such a construction requires the least sealing efforts compared to a vent conduit leading at least partly through the interior of the tank. Furthermore, the tank according to the present invention is adapted to be introduced into mobile toilet systems which are already in use. [0010] Preferably, the first location is on the top side of the housing. Such an arrangement reduces the risk of the content of the tank reaching the vent conduit through the vent opening and avoids a contamination of the vent conduit. [0011] Furthermore, it is advantageous when the second location is on the bottom side of the housing. According to this arrangement, the vent conduit could be formed as short as possible, i.e., having a minimal length. Additionally, no extra installations leading around the tank are required to connect the vent opening with the bottom side of the tank. [0012] In principle, it would be possible for the vent conduit to be formed by a plurality of conduits. Preferably, the vent conduit comprises a channel having a first end and a second end. A channel of this kind reduces the number of connections which have to be sealed to a minimum. [0013] According to a preferred embodiment of the invention, the channel is formed by a tube extending vertically through the tank. Such a tank is easy to produce since only two openings have to be formed, one on the top side and another one on the bottom side of the tank. The tube can easily be inserted through the openings so as to form a passage through the interior of the tank and allow the waste air to leave the tank and to be guided through the interior of the tank to the exterior without coming into contact with the waste contained in the tank. [0014] To prevent waste air from escaping from the tank when the tank is, for example, in a stored position outside the mobile toilet system, a closure is provided, the closure opening the vent opening in an open position and closing the vent opening in a closed position. Such closure additionally holds back the contents of the tank to avoid a splashing of the contents when the vehicle is moved and a contamination of the vent conduit. [0015] In principle, the closure could be electrically actuatable. According to a preferred embodiment of the invention, however, the closure is mechanically actuatable. This allows opening of the vent opening automatically or manually when a venting of the tank is required. [0016] Although the closure could be formed by a cover or a screw cap, it is beneficial for the closure to be formed by a valve. [0017] In principle, the valve could be a simple valve. However, it is advantageous for the valve to be a safety valve. With such a valve, an unintentional opening of the vent opening can be avoided. [0018] Since it is not guaranteed that the contents of the tank will not pass through the vent opening and contaminate the vent conduit when the closure is in the open position, it is preferable for the closure to comprise a movably supported float for reversibly opening and closing the vent opening in the open position of the closure. Such a float allows closing of the vent opening when the closure is in the open position. For example, the float can be actuated by the contents of the waste tank, i.e., if the tank fills up, the surface of the waste (the upper waste level) inside the tank forces the float to close the vent opening. [0019] Although the closure could be actuated manually, it is advantageous for an actuation mechanism to be provided for reversibly moving the closure from the open position to the closed position. The actuation mechanism allows opening and closing of the closure automatically. In principle, the actuation mechanism could be actuated manually or automatically, e.g. electrically or by air pressure. [0020] Although the actuation mechanism could be actuated manually, it is preferable to provide an automatic actuation of the closure. This could be advantageously realized in such a way that the tank is movable from an inserted position to a retracted position, the tank being inserted in the base section in the inserted position and being retracted from the inserted position in the retracted position, the actuation mechanism being actuatable by moving the tank from the retracted position to the inserted position. This allows an automatic opening and closing of the vent opening by inserting or retracting the tank into or out of the base section of the mobile toilet system. [0021] In a preferred embodiment of the invention, the actuation mechanism comprises a movable actuation member supported by the tank and cooperating with an actuation element supported by the base section during the movement of the tank from the retracted position to the inserted position. Such a construction requires a minimum of movable parts since the actuation element need not be a movable member. [0022] Preferably, the actuation member is arranged within the vent conduit and extends in the direction of the vent conduit. The arrangement of the actuation member within or at least partly inside the vent conduit provides protection of the actuation member against contamination and destruction. Furthermore, the actuation member could be completely hidden within the tank. [0023] To improve the stability of the actuation member and also to increase the waste air flow through the vent conduit, the actuation member has a cross-shaped cross section. [0024] Although the actuation element could be a movable member, e.g. a push button, it is preferable that the actuation element be formed by an inclination. This allows the actuation member to move or glide along a surface of the inclination which results in a movement of the actuation member in a direction transverse to the inclination. [0025] In order to also provide an outlet for the waste air with a cross section of maximum size, the actuation element is formed by a web extending across a through-opening of the base section. This allows the waste air to pass bthe web and to flow through the through-opening of the base section. Furthermore, waste air flow is maximized. [0026] Preferably, the closure is in the closed position when the tank is in the retracted position. Therefore, it is advantageous for the actuation mechanism to comprise a biasing member for biasing the closure in the closed position when the tank is in the retracted position. This avoids any leakage of the tank when the tank is in the retracted position, which, for example, could result in a contamination of the vent conduit. [0027] In another preferred embodiment of the invention, the actuation mechanism comprises a pivotally supported transfer element interconnecting the actuation member and the closure. This allows an actuation force to be transmitted from a first direction to a second direction via the transfer element. For example, if the actuation member extends vertically through the tank and the vent opening is located on the top side of the tank, an up-and-down-movement of the actuation member has to be transmitted to an up-and-down-movement of the closure. This could be easily achieved with the transfer element. [0028] In principle, the biasing member could be allocated to the closure itself or to the actuation member. However, it is preferable for the biasing member to be allocated to the transfer element. This allocation allows a reduction in the size of the biasing member and also exact adjustment of a biasing force. [0029] The actuation mechanism could be easily hidden and protected if it is at least partially arranged in a recess formed on the exterior on the top side of the tank. [0030] In order to conceal the actuation mechanism and form an impervious air passage between the vent opening and the vent conduit or the channel, according to a preferred embodiment of the invention it is provided that the recess is closed with a cover, the covered recess forming a second conduit, the second conduit being in fluid communication with the first end of the channel and the vent opening. [0031] Preferably, the transfer element is arranged in the recess. This allows formation of a shallow recess, which has the advantage that almost the entire inner height of tank could be used for storing waste without the risk that the waste will splash through the vent opening and contaminate the vent conduit. [0032] For further improvement of the venting system, a vent line connector is supported by the base section, the vent line connector being connected to the second end of the channel in the inserted position of the tank. This arrangement allows the waste air to be guided further outside the mobile toilet system, i.e. through the base section to the exterior of the toilet room or the vehicle in which the toilet system is located. [0033] To avoid further unpleasant irritation by odors a sealing member is provided for sealingly connecting the vent line connector with the second end of the channel. [0034] A very inexpensive and easy way to seal the vent line connector to the second end of the channel is for the sealing member to be formed by a foam sealing arranged around the vent line connector. [0035] The vent line connector could be formed by a flange to be connected to a tube system leading the waste air to the outside of the toilet room or the vehicle. However, the vent line connector is preferably a hose connector. Hoses are adapted to fit in almost all situations in a vehicle, especially in caravans or motorhomes. Furthermore, hoses are very cheap and can easily be bent into a shape which is necessary to reach around corners and edges. [0036] According to a further preferred embodiment of the present invention, the base section comprises an opening for passage of a third conduit connectable to the second end of the channel and/or the vent line connector. This offers the advantage that the waste air can be led through the vent opening and the vent conduit formed by the channel to the second end of the channel which can be connected to a vent line connector and through the third conduit to the exterior of the base section and further to the exterior of the toilet room and/or the vehicle. [0037] In an advantageous embodiment of the present invention, a cavity is provided in the base section and the vent line connector extends into the cavity. This allows an easy connection of a further air guiding line to the vent line connector. [0038] In special cases where it is not possible to lead the waste air to the exterior of the toilet room or the vehicle and even in cases which allow an air flow to the exterior, unpleasant irritation could be reduced or completely avoided by using a filter element. Preferably, the filter element is connectable to the vent line connector and locatable in the cavity. This allows easy changing of the filter element after retraction of the tank. Furthermore, the filter element is optimally stored and protected. [0039] Furthermore, the object as mentioned above is achieved in accordance with the present invention with a mobile sanitary toilet system comprising a base section, a bowl section supported by the base section and a waste holding tank in that the system comprises a waste holding tank as described above. BRIEF DESCRIPTION OF THE DRAWINGS [0040] The following description of a preferred embodiment of the invention serves to provide a more detailed explanation, in conjunction with the drawings, in which: [0041] [0041]FIG. 1 is a cross-sectional view through a waste holding tank inserted in a base section of a mobile toilet system. [0042] [0042]FIG. 2 is a sectional view of a part of a tank in a retracted position. [0043] [0043]FIG. 3 is a cross-sectional view along line 3 - 3 in FIG. 1. [0044] [0044]FIG. 4 is an exploded view of elements of an actuation mechanism. [0045] [0045]FIG. 5 is a cross-sectional view along line 5 - 5 in FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0046] [0046]FIG. 1 shows a part of the mobile toilet system indicated at 10 , namely a base section 12 and a waste holding tank 14 in an inserted position, i.e., completely inserted in a housing 16 formed in the base section 12 . [0047] The tank 14 comprises a housing 16 having a top side 20 and a bottom side 22 . On the top side 20 of the housing 18 a block-shaped recess is formed and closed by a cover 26 . A bottom plate 28 of the recess 24 is provided with a circular hole 30 which is surrounded by a tubular flange 32 extending into an interior 34 of the tank 14 . A second circular hole 36 which is about three times smaller in diameter than the hole 30 is also provided in the bottom plate 28 . The hole 36 is surrounded by a tubular section 38 extending into the interior 34 . [0048] The hole 36 serves as a vent opening of the tank 14 and contains a vent pivot 40 which is movable along an axis of the tubular section 38 . The hole 36 and the vent pivot 40 form a valve unit for reversibly opening and closing the vent opening. [0049] A vent lifter 42 forming a part of an actuating mechanism for lifting and lowering the vent pivot 40 comprises a bearing shaft 44 and a U-shaped first end 46 which is connectable with the vent pivot 40 . For this reason, the vent pivot 40 comprises two vent flanges 48 and 49 . The first end 46 engages between the flanges 48 and 49 . [0050] As shown in FIG. 5, sidewalls 50 a and 50 b of the recess 24 which comprise receptacles 52 a and 52 b for receiving ends of the shaft 44 form a hinge for the vent lifter 42 . The axis of the shaft 44 extends parallel to the bottom plate 28 and transversely to a line connecting the holes 30 and 36 . Furthermore, the vent lifter comprises a pot-shaped receptacle 54 for receiving a spring 56 which is held in position by a tubular spring locating section 58 . The spring locating section 58 is arranged on the bottom plate 28 and extends in a direction towards the cover 26 . The spring 56 is arranged between the bottom plate 28 and the vent lifter 42 such that the first end 46 of the vent lifter is forced towards the cover 26 for keeping the vent opening in an opened position. [0051] A hole 60 is formed in the bottom side 22 of the tank 14 and connected with a tube 62 which extends vertically through the interior 34 of the tank 14 and reaches with a diameter-reduced tube section 64 through the hole 30 . An O-ring 66 is fitted between the flange 32 and the tube section 64 for sealingly connecting the tube 62 to the bottom plate 28 . The vent hole 36 in connection with the covered recess 24 and the tube 62 form a vent path for guiding waste air from the interior 34 of the tank 14 to the bottom side 22 of the tank 14 through the interior of the tank 34 without being in fluid communication with the interior of the tank 34 . [0052] A vent actuator 68 having a cross-shaped cross section is located within the tube 62 and movable along a tube axis 70 . An upper end 72 of the vent actuator 68 comprising an opening 74 is adapted to receive a second end 47 of the vent lifter 42 . A movement of the vent actuator 68 towards the cover 26 lifts the second end 47 of the vent lifter 42 towards the cover 26 and lowers the first end 46 of the vent lifter 42 at the same time against the biasing force of the spring 56 . When the first end 46 of the vent lifter 42 is lowered, the vent pivot 40 is in a lowered position opening an air path through the hole 36 and through the vent pivot 40 . This position, the so-called open or venting position, is shown in FIGS. 1 and 3. [0053] As shown in FIG. 2 where the tank 14 is in a retracted position, i.e., any position different from the inserted position shown in FIG. 1, the first end 46 of the vent lifter 42 is forced in a direction towards the cover 26 by means of the spring 56 so that the vent opening formed by the hole 36 is closed by the vent pivot 40 . At the same time, the vent actuator 68 is forced into a lowered position. [0054] For automatically actuating the vent actuator 68 , a base plate 76 of the base section 12 has a circular opening 78 which is formed by a tubular-shaped hose connector 80 . The upper edge 82 of the connector 80 extends towards the tank 14 and is inclined at about 10 to 15°. A web 84 extends over the opening 78 and is connected with the highest and the lowest sections of the edge 82 . The web 84 is inclined in a direction parallel to the opening 74 . [0055] The connector 80 extends into a cavity 86 formed in the base plate 76 . A hose 88 shown in dotted lines in FIG. 1 may be connected to the connector 80 and led through the bottom of the cavity 86 to the exterior, for example, of a toilet room or a vehicle. [0056] Alternatively, a filter element 92 may be arranged within the cavity 86 and connected to the connector 80 for cleaning the waste air led through it. [0057] For obtaining a sealed connection between the tank 14 and the base section 12 , the hole 60 in the bottom side 22 of the tank 14 is prolonged with a tubular connector 94 having an inclined edge 96 . The opening 78 is surrounded by a base plate seal 98 made of foam. [0058] Before using the toilet system 10 , the tank 14 has to be inserted into the housing 16 of the base section 12 . During insertion, the tank 14 slides along the base plate 76 of the base section until a front edge 100 abuts a stop 102 formed on the base plate 76 . During the insertion of the tank 14 , a lower edge 104 of the vent actuator 68 slides along the inclined web 84 which results in a movement of the vent actuator 68 towards the cover 26 . At the same time, the second end 47 of the vent lifter 42 lifts up and the first end 46 is lowered. In the inserted position of the tank 14 shown in FIG. 1, the vent opening is open and the waste air inside the tank 14 can flow through the hole 36 and the vent pivot 40 , the covered recess 24 , the tube 62 and the connector 80 and, for example, through a hose 88 to the exterior of the vehicle. Since both the edge 82 of the connector 80 and the edge 96 of the connector 94 are inclined, and the seal 98 surrounds the opening 78 , the edge 96 contacts the seal 98 in such a way that air cannot leave the above-described vent path. [0059] When the tank 14 is retracted from the inserted position, the vent actuator 68 moves away from the cover 26 and the biasing force of spring 56 results in a lifting-up of the first end 46 of the vent lifter 42 . The vent opening is thereby automatically closed. [0060] For closing the vent opening in the bottom plate 28 of the recess 24 when the vent pivot 40 is in the open position as shown in FIG. 1, a float 106 is provided. The float 106 comprises a float holder 108 which is slidably supported in a central bore 109 of the vent pivot 40 . The float holder 108 carries a float stem 110 in the form of a disk whose one circular side is covered by a disk 112 of foam. In order to close an air path when the vent pivot 40 is in the open position, a vent seal 114 is arranged around the hole 36 having an inner diameter which is about three times larger than the diameter of the hole 36 . [0061] The float 106 is connected to the vent pivot 40 and forms a safety valve which closes the vent opening when the upper waste level inside the tank 14 rises above a certain level and comes into contact with the disk 112 . As the waste level rises further, the disk 112 connected to the float stem 110 moves towards the cover 26 until the float stem 110 comes into contact with the vent seal 114 . When the float 106 is actuated, it is impossible for waste to pass through the vent opening inside the recess 24 , which would result in a contamination of the actuating member. [0062] Construction of a waste holding tank 14 as indicated above, i.e., with an improved venting system, has a quadruple function. [0063] First, it is possible to guide the waste air from the faeces out of the tank 14 through the interior 34 despite the waste located there. The location of the outlet for a waste air guide, e.g. the tube 62 , can be chosen optimally and be adapted to the requirements of the base system, i.e., the vehicle or the toilet room. [0064] Second, it is possible to install the necessary actuating mechanism for valve control in the vent conduit. [0065] Third, the tank 14 can be easily transported since the vent opening is closed when the tank is in the retracted position. [0066] And fourth, it is possible to change the function of the safety valve to a float when the actuating mechanism is activated, i.e., when the tank is in the inserted position. [0067] The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.

A waste holding tank for a mobile sanitary toilet system includes a base section, a bowl section supported by the base section and a waste holding tank. The tank includes a housing defining a tank interior and a tank exterior. A vent opening is located at a first location of the housing. The opening forms a fluid communication between the interior and the exterior of the tank. A vent conduit connects the vent opening on the tank exterior at the first location with the exterior of the tank at a second location of the housing. The vent conduit leads at least partly through the interior of the tank without being in fluid communication with the interior of the tank.

CROSS REFERENCE TO RELATED APPLICATIONS Reference is made to and priority is claimed from U.S. Provisional Patent Application Ser. No. 61/217,326 filed May 29, 2009 the disclosure and contents of which are incorporated herein by reference. FIELD OF THE INVENTION The present invention relates generally to jewelry and more specifically to jewelry containers and in particular to an adaptable/adjustable jewelry container for cremation ashes, DNA material, soil and like substances and materials. BACKGROUND Jewelry cremation containers are disclosed for example in U.S. Pat. Nos. 5,158,174 and 5,208,957 to Hereford and U.S. Pat. No. 5,755,116 to Sparacino. Hereford discloses a cremation jewelry container with a minor container and a major container to be combined to create a pendant which could hold multiple samples for example from different donors. The minor container in Hereford is described and illustrated as a cylinder tube which is closed at its bottom with an open cavity to allow cremated ashes to be placed inside, before being closed by a cap which possesses a flat surface which exceeds the outer circumference of the minor tube and is basically illustrated in FIG. 3 as a bigger sleeve cylinder section ( 20 ), with a smaller sleeve and cap ( 40 ), which fits into the larger cylinder ( 20 ). The cap is larger than the inside dimension of its companion sleeve or tubing. The major container is described as decorative, in pendant style, which will act as a housing unit for singular or multiple minor containers. Hereford provides a piece of jewelry with a singular purpose, which is to hold minor containers. Although stylish, it requires both containers to complete the Hereford's intended desire to secure the cremated ashes in a fashionable apparatus. The minor container does not seem to have an identity independent of the major container. Sparacino discloses that two similarly sized and dimensioned cylinder or flange designed components will comprise its cremation container. They will slip over each other to form the completed container. It will be threaded or the use of a silicone sealant will secure ashes or other material within its cavity. The cavity compartment will permit the deposit of multiple samples, such as cremated ashes, a lock of hair, or tooth, as a few illustrations of deposits separately housed with the container. Sparacino also describes placing said container within another hollowed out piece of jewelry, with two reflective matching parts; such as but certainly not limited to a locket device commonly seen in the jewelry industry, or some other style piece with two halves. The completed container can then be placed and hidden within said piece and sealed together with silicone sealant. Sparacino also describes the use of decorative marking, jewels, and etched information being placed on the front and back covers to enhance the commemorative value of the container to the user The present invention differs from both Hereford and Sparacino on many different levels. One of the differences is both the Hereford and Sparacino containers are designed to hold multiple samples. In contrast the present invention possesses a singular chamber 8 for use in holding a definitive sample as described herein. Multiple samples could only occur by incorporating multiple containers or contaminating the cavity with multiple items for deposit. Therefore for a woman who may have lost her husband, and child and got married on the beach in St. Thomas; she would have to place each sample of corresponding material into its own container. Then each container could be soldered behind a specific independent piece of jewelry, or in the case of a written charm, placed top, bottom and sides, either in a row or scattered about the piece. In one example, the adaptable/adjustable jewelry container embodying the present invention is configured to function as an independent piece of jewelry as shown for example in FIG. 5A , FIG. 5B and FIG. 5C , to provide the possibility of different and distinct samples sharing the same environment, such as but not limited to, a charm bracelet or necklace will allow for the adaptable jewelry containers to be present in the same general area. In another example, the present invention is configured as giftware to provide separate but multiple containers that may share the same frame as shown for example in FIG. 10 , plaque plate FIG. 11 or other forms of giftware, by drilling additional holes or receptacles for the containers to then be secured with an appropriate form of adhesive. A further difference between the Hereford and Sparacino is in the ability of the present invention to adapt and accent another independent piece of jewelry or giftware, while still remaining visible to the eye, and not compromising the aesthetic design intended by the original piece of jewelry FIG. 4A , FIG. 4B , FIG. 4C . This is accomplished on multiple levels within the design of the present invention, and particularly in its ability to change its shape and size, as well as the total depth of the jewelry container, while maintaining its principles of design, makes it possible to fit into, on top of or alongside of, almost any piece of jewelry or giftware item FIG. 9 . The adaptable jewelry container can also mimic the design of the original item, such as but not limited to, diamond cutting the top or bottom caps, or adding a single or multiple diamonds. It can also be accented with colored stones and engraving of symbols, initials, hearts, crosses or some other ornamental design to enhance the original design. Although Sparacino makes reference to the possible use of etched information, and jewels and decorative markings to enhance the commemorative value of its container, the container's explicit design is to be concealed within another piece of jewelry which makes it symbolic and not ornamental. Both Hereford and Sparacino keep the container holding the ashes hidden and do not accent or enhance the designs in which they are being placed. A yet further difference between both the Hereford and Sparacino containers and the present invention for an adaptable and adjustable design for holding the cremated ashes of animals, humans, or other species, as well as the possibilities of different forms of soil/sand in an airtight container, is in its basic design. Hereford and Sparacino both rely on the concept of a cylindrical bottom with its cap already in place. The top in the Sparacino design uses a similar sized top flange or cylinder to be secured with silicone. Hereford uses a larger flat plate on a tube or cork, which then slips into the opening of its bottom minor container counterpart. In contrast, when the present invention takes its shape, such as but not limited to, oval, pear, marquise, star or square, the bottom of the present invention's base is open with thicker walls than its top, to allow for any minor adjustments in height and cavity size to conform and accent another item. The top cap 14 and bottom cap 16 are solid in the present invention, and have no tubing attached to assist in effectively closing the containers chamber, as both the Hereford and Sparacino designs incorporate. The present invention instead uses a design bezel recessed top base 12 and a solid top cap 14 with a slight tapering 15 from its top surface to bottom surface, which is arranged to sink down and rest snugly to the larger opening. The solid top cap 14 is also arranged to rest on the ledge 7 created by the making of the bezel. The bottom cap 16 is also solid, but smaller than the top to seal narrower opening at bottom of base 12 . Each end cap, depending on the material in which it is made, may be sealed by any suitable means, such as, for example, laser or conventional soldering, or generous use of a suitable adhesive to carry out the intended function. Another difference between the containers disclosed by Hereford and Sparacino and the present invention, is that with simple modifications, while keeping true to the initial designs concept, the adaptable jewelry container may be configured to function as an independent piece of jewelry FIG. 5A , FIG. 5B , FIG. 5C , FIG. 6 and FIG. 7 , will be accomplished for example, with the addition of a loop or loops being placed on the base part of container. When one loop is added to the center of the base, FIG. 5A , FIG. 5B , FIG. 5C , FIG. 7 , it will require either a bale or jump ring, so that the container can swing freely on a chain or bracelet. When adding multiple loops, such as in three, FIG. 6 but not limited to these restrictions or numbers, the adaptable jewelry container will replace the junction between the two strands of beads and the beads and cross in a set of rosary beads. The top cap can then be made ornamental with engraving, addition of diamonds or genuine or synthetic stones, or by using a standard size religious charm to replace the top cap, which will fit at top of bezel base and act as a substitute for sealing the top of the container. Neither Hereford nor Sparacino possess this capability. Both Hereford and Sparacino require some outside device to encase either their minor container as disclosed in Hereford or major container as disclosed in Sparacino which then transforms the major or minor container into a co-dependent piece of jewelry. A further difference between the present invention for a jewelry container which can secure the cremated ashes or DNA or earthly material within its chamber, is its ability to be manufactured in materials other than those mentioned in either Hereford or Sparacino. The Hereford and Sparacino containers are limited in their claims to the field of metals, and would not be practical or in some cases possible to produce in other materials. In the case of the Hereford design, the minor container would pose a problem, as its cap has to be soldered, while its major container, after inserting the minor container, might be possibly sealed with silicone, as soldering is not an option in either plastics or wood. Sparacino calls for two threaded or overlapping two part flange or cylinders. Although this might be possible in plastics, but not disclosed, it still falls short of a successful design, when having to be encased within another two separate piece hollowed design, with only the use of silicone to secure and align all three pieces. The three pieces previously mentioned would be the completed container and two separate outer designs mentioned. Therefore the containers in Hereford and Sparacino could not be produced in woods and plastics. This present invention for an adaptable jewelry container, works with the same design functions regardless of the material from which it is ultimately produced and still retains its ability to adjust its height before sealing cremated ashes, DNA or other mentioned materials, by means of adjusting the bottom of the base before sealing with the bottom end cap SUMMARY A jewelry container, which can store inside a single chamber the cremated ashes or DNA of animals, humans, and any other species known to man is disclosed. There could also be the possibility of placing soil or sand within its cavity. This invention will provide an airtight container which could adapt itself to another object or piece of jewelry. Accenting and enhancing the original piece, while proving a safe environment for the contents. Altering its shape and sizes allows for the adaptable/adjustable jewelry container to blend or hide behind separate jewelry items used as its compliment. It will also function in different shapes and sizes, as an independent piece of jewelry in its own right FIG. 5A , FIG. 5B , FIG. 5C and FIG. 7 . It will also be featured in its own line of designs, with the bottom cap and bottom base pre-molded to each piece designed, examples being but not limited to, crosses FIG. 8A , hearts FIG. 8B , stars FIG. 8C , religious symbols and animals. The adaptable jewelry container will be manufactured in various materials to provide a cost which can be comfortable to all markets and users. The common bond between all these samples is that they all represent the sentimental entities which inspire thoughts of love and comfort to the user. Having a special moment or thought represented by a unique piece of jewelry has been a custom pasted down through many generations. Having a grandmother's charm, ring or bracelet given to the first born girl in the family was established centuries ago and still practiced to this current time. The need for a physical connection to the people, pets and memories that hold significance in our lives, has in many instances, been represented through furniture, pictures and jewelry, and gives a sense of connection to one's past and a positive feeling of transferring these special moments to future generations. This invention's ability to be added to a special charm, bracelet, necklace, pendant, ring, money clip, or key ring, owned by the user, ties the past to the future. This capability provides a means of securing the cremated ashes or other material, in a manner and versatility not previously disclosed or known hereto. An adaptable/adjustable jewelry container to secure the remembrance of cremated ashes or DNA of any species, or a sample of dirt or sand in a single airtight chamber is disclosed. The unique attributes of this invention, is in its ability to be added to and accent or enhance almost any secondary piece of jewelry, such as but not limited to, written charms FIG. 4A , regular open back charms FIG. 4C and pendants FIG. 4B , and money clips. A slight modification, by means of a strategically placed jump rings or loops 11 , allows it to act as an independent container FIG. 5A , FIG. 5B , FIG. 5C , capable of holding above mentioned remembrances, so they can then be placed on a chain, necklace, or charm bracelet in a free moving manner, or be used as a main component of rosary beads. These are just a few of its potential uses, but in no way limiting its future possibilities. In one example, the adaptable/adjustable jewelry container of the present invention is comprised of a bezel designed base 12 , which possesses a larger top opening with thinner side walls 6 and extends down and stops, to create a ledge 7 within the base 12 . The bottom walls of base 12 is thicker than top walls forming the chamber 8 , and the opening smaller, so there can be no mistake, no matter what shape or size of the adaptable/adjustable jewelry container, which is top or bottom of base 12 . The base 12 will be sealed with solid end caps with an appropriate thickness to allow for setting of stones, engraving or other means of ornamentating its surface. The top cap 14 will be larger by design, and to fit snugly to inside bezel dimensions and be of such thickness to meet or extend slightly above the lip of bezel wall 6 . In most but not all cases, the top cap 14 will be secured to the base 12 first, so that any adjustments in height FIG. 2A , FIG. 2B , can be made before one of the above mentioned materials are placed in chamber 8 . The bottom cap 16 will be made the same thickness, although smaller in size so that it can snugly slip inside to adjust the height of container. The seal created by the same shape end caps will provide an airtight seal. The final step to assure a safe and reliable seal will be attained with laser or conventional soldering, or depending on materials used to create the container, an appropriate adhesive agent. These end caps in certain shapes, such as but not limited to, oval, round and square, may be replaced with a religious or common charm, to secure one or both ends. The adaptable/adjustable jewelry container will generally but not necessarily be produced in metals related to the jewelry industry, such as but not limited to, all colors and karat weight of gold, silver and platinum. In the gift line area of production, the adaptable jewelry container might be made in brass, stainless steel, titanium, plastics, resins, and a variety of woods. In certain cases to either mass produce or create a cleaner surface for the containers' overall appearance, either top cap 14 or bottom cap 16 may be pre-assembled or molded to its corresponding base 12 . While the end cap remaining will be used to secure the chamber once cremated ashes, DNA, or other material is placed within the chamber 8 of the container. The description herein refers to possible variations of this new invention for an adaptable/adaptable jewelry container, and is in no way to be seen or to be limited to these described examples. The examples are illustrated to show the unique and varied ways for this inventions practical uses within the context of the jewelry industry and the users needs to contain a treasured remembrance of something or someone of significance in their life. BRIEF DESCRIPTION OF THE DRAWINGS Other features, advantages and benefits of the present invention will become readily apparent from the following description taken in conjunction with the drawings wherein: FIG. 1 is a exploded view showing the three parts that comprise the adaptable/adjustable jewelry container 10 in its round shape which may be made in various sizes, 2 mm and larger. The top cap 14 (reversed to show tapering 15 ) which is slightly smaller at bottom, so that it fits snugly when resting on the ledge 7 . The bottom cap 16 which is smaller in size than top cap 14 is made in this manner to accommodate the thicker bottom walls, which extend from the ledge 7 to the end of the base 12 . FIGS. 2A and 2B shows the bottom of side view of base 12 , broken lines 2 to illustrate one of many possible positions where the base can be adjusted in height and cavity size to better adapt to its environment. FIGS. 3A and 3B shows examples of possible other shapes 12 ′, 12 ″ the container may assume such as, oval and pear shape, but not limited to these only. FIGS. 4A , 4 B and 4 C illustrates some examples 4 A of a written “Love You”, 4 B Heart Charm, 4 C Rabbit Charm, and how the adjustable/adaptable jewelry container 10 of the present invention may be used to accent and enhance a separate piece of jewelry. Although these illustrations show only one of many positions the container 10 may be placed. FIGS. 5A , 5 B and 5 C are examples of how the adaptable jewelry container 10 with the modification of adding a loop 11 in center of base, and increasing its size, can act as an independent piece of jewelry. FIG. 6 shows an example of how by adding three loops, one bottom center 32 , and two top 32 and equally apart on the base 12 , the design will mimic the intersected ornamental bottom of a set of rosary beads that connects the beads to the cross. FIG. 7 shows how a religious medal, or other similar shaped designed top, with marking significant to user, in this case but not limited to, round or oval, could be used to replace top cap 14 . FIGS. 8A , 8 B and 8 C shows examples of possible designs which will include two of the pieces of jewelry container comprising of the base 12 and either bottom cap 16 , or top cap 14 , already attached to jewelry, so that only top or bottom cap will be needed to seal container in manufacturing. This does not in any way reflect the full scope of line being created, or limit the rights and ability to use other shapes as possible replacements for round design shown attached. FIG. 9 shows a wooden paperweight and pen set with a golf motif, adapted to hold the design for an adjustable/adaptable jewelry container of the present invention, by sinking the container 50 into the wooden base. FIG. 10 shows how a simple picture frame may be modified to hold adjustable/adaptable jewelry container 10 of the present invention. FIG. 11 shows an alternate way of attaching the container 10 , first onto a plate that can be engraved, then placed onto picture frame or plaque after drilling a hole into material the same size as container 10 . FIG. 12 illustrates an example of how the container 10 can be placed and attached to traditional basket settings of different shapes and dimensions. DESCRIPTION The adjustable/adaptable jewelry container was invented to preserve the memory of a special moment, such as but not limited to, the sand from the beach in St. Thomas, where a couple was married, or the soil from the footprint of the twin towers, or a plot where a loved one was buried, or the cremated ashes or DNA of a cherished pet or family member. It can also be attached to a special charm given by the deceased, or added to any other item which creates a bond between the contents of the container and the owner. The present invention is a design for a three-part adaptable and adjustable jewelry container where two or more parts will be used to complete the container, and allow the cremated human, animal, or other species ashes, DNA material or soil to be placed within an airtight apparatus. The completed container 10 will then be attached to another piece of jewelry or giftware. Whether in plain frontal visual sight, as in but not limited to, a written “someone special” or “I love you” charm FIG. 4A , or in some instances may be attached on top of a heart, cross, or calendar charm while in other cases may be soldered and affixed to the back of almost any open backed charm FIG. 4B common in the jewelry industry. The adaptable/adjustable jewelry container will also function independently when completed in various shapes and sizes known to be common in the jewelry industry, some of which shapes are, but not limited to, round FIG. 7 , oval FIG. 5A , pear shape FIG. 5B , marquise, square, star FIG. 5C and heart designs, which may be modified with a loop/jump rings 11 attached to the container, so that a bail for necklaces and pendants, or another loop/jump ring, will allow the adaptable/adjustable jewelry container to be placed onto a bracelet of various styles know in the jewelry industry. Ornamental designs maybe placed onto both the bottom and top caps. Engraving of initials, FIG. 5A and dates, as well as symbols such as eternity, infinity, cross or hearts will also be possible with this design. It is also contemplated that diamonds and other stones can be set into both the bottom cap 16 and top cap 14 . In an illustrative example the present invention uses three pieces FIG. 1 to construct an adaptable/adjustable jewelry container which will adjust by means of size, shape and height FIG. 2A to FIG. 2B and be used to store the cremated ashes or DNA of either human, animal or other species, as well as soil or sand, in a sealed airtight manner which will protect the enclosed sentimental material. Once the container is complete 10 , it will be attached to another independent piece of jewelry or giftware. The container's main component is comprised of a base 12 , which has a bezel design top, which by nature in the jewelry industry is recessed with a larger opening 6 to allow for the top cap 14 to sink down and be held by the ledge 7 . The bottom and corresponding opposite end of the base, has a smaller opening, with thicker walls which match the overall dimensions of the chamber 8 , which starts at the ledge 7 . This feature will permit the base to be modified in height before the container is closed and secured with bottom cap 16 . The top cap 14 will be larger than the bottom cap 16 because of the opening on the bezel end of base will have thinner inside walls 6 , with a larger circumference. The top cap 14 will be made thick enough, to at least reach the top of the bezel end side walls 6 , or to slightly extend past said wall. The top cap 14 and bezel end of base will then be secured by either soldering or adhesive, depending on the material which ultimately identifies the jewelry container. These two pieces will create a single chamber 8 or storage unit. When using most metals know to man, this process will be done by means in the jewelry industry associated with soldering, both laser and conventional. When the container is produced from plastics, wood or some other material not previously mentioned, the procedure of securing the top cap 14 and bottom cap 16 will be attained by means of a suitable adhesive to carry out the intended function. Another example of this invention will have both ends of the base container mirror the opening of its opposite end and which will incorporate the larger bezel design features at both ends of the base or the smaller bottom. In this example the two caps will be the same size. This variation of the invention will allow for the front and back caps to be replaced with ornamental caps FIG. 6 and FIG. 7 , which may include, but not restricted to, a different religious saint or symbol at each end of the base, so the symmetry of the two caps would visually be more esthetic when made in the same size. The top cap 14 and the bottom cap 16 , no matter their size, along with the base 12 , in examples stated above, will create a single chamber or storage unit. When using most metals known to man, this process will be done by means in the jewelry industry associated with soldering, both laser and conventional. When the container is produced with materials which cannot be subjected to heat, such as but not limited too, plastics, wood or glass, the procedure of securing the top cap 14 and bottom cap 16 will be attained by means of a reliable adhesive. Adhesive will also be used in examples when sample in containers is sensitive to heat, or if being assembled for immediate use or delivery. The top cap 14 and bottom cap 16 will match the shape of the base unit FIG. 3A , FIG. 3B , FIG. 5C and will fit with minimal to maximum resistance into their respective openings. In one example of the invention the top cap 14 and bottom cap 16 will form a seal without the use of solder or adhesive into their respective openings, by tapering the edge of one side of the top cap 14 and bottom cap 16 ( FIG. 1 ) to form a variation of a compression fit, so that when tapped by a hammer or pressed with some force will secure contents before final phase of closure is completed. The bottom or non-bezel portion of the base 12 will be adjusted in height FIG. 2A , FIG. 2B by means of cutting with a saw blade, filing, or using grinding wheel or other suitable means. The forming of this design feature does not need to be to perfect, as any uneven excess metal or material will be removed after the chamber 8 is filled and the smaller base cap 16 is secured by means of above stated methods of closure. The completed container 10 will then be attached or placed onto another item of jewelry FIG. 4A , FIG. 4B , FIG. 4C or giftware FIG. 9 and FIG. 10 to give the appearance of a new unique piece of jewelry. The adaptable/adjustable jewelry container will in most cases when using metals, be attached by means of laser or conventional soldering, someplace on, behind or around edges of converted jewelry. The flexibility of this container, is depending on its size and shape, such that it can be incorporated to appear as if it is an extension of the original piece of jewelry, or hidden behind the exposed backside of most charms, and rings, or on top of bracelets and in front, sides or back of pendants. The adaptable/adjustable jewelry container may be made in sizes and shapes that are common in the jewelry industry. Although a round container is discussed above, it is in no way limited to such a shape restriction. The round adjustable jewelry container will have the versatility to be made in sizes from 2 mm to 70 mm or larger. It will also be made in oval, marquise, pear shape, square, emerald, star and heart shape, as well as other shapes not mentioned but deemed recognizable in the jewelry industry. These different shapes will also be made in various sizes, and will conform to the same parameters as stated above whereby the shapes will possess a base 12 , 12 ′ 12 ″ with a top bezel design, which will accommodate a larger same shape top cap 14 and smaller same shape bottom cap 16 , so that the height can still be adjusted to suit the independent piece. These different shapes will include but not be limited to, the standard dimensions found to be common in the jewelry industry. The adaptable/adjustable jewelry container 10 as discussed above, should be arranged to have a top cap 14 and bottom cap 16 of different dimensions, and be made thick enough to accommodate the addition of diamonds, other stones, deep engraving, creative designs, such as an infinity, eternity, cross, or heart, but not solely restricted to these designs. The top cap 14 and bottom cap 16 may also be substituted with a conventional religious FIG. 7 or specialty charm ( FIG. 9 ) 50 that conforms to the dimensions and parameters of its corresponding base. In another example, the adaptable/adjustable jewelry container of the present invention can also function independently when completed in larger sizes FIG. 5A , FIG. 5B , FIG. 5C , and FIG. 7 , to form its own identity. Depending on the shape and size of the container 10 , and the addition of one or more loops 11 or bale, the container can swing freely on a chain or charm bracelet. While with the modification of three loop/jump rings 32 , two placed evenly apart at top of oval or other shaped design and one center bottom, the adaptable/adjustable jewelry container will form the focal point of a line of rosary beads FIG. 6 whereby the top or bottom end caps may be replaced with religious medals or other ornamentation. These examples are not to be taken as the only modifications of the basic design which would create new versatile lines of jewelry. When the adaptable/adjustable jewelry container is being used in an exclusive line of jewelry, such as, but not limited to, crosses, hearts, stars, animals, written charms, or regular charms symbolizing sea, plant, islands or other locations or sports, the base 12 with smaller bottom opening closed with bottom cap 16 , will be incorporated into the mold or die cast to make it easier and neater to manufacture jewelry with the partial container already placed in its desired location. FIG. 8A , FIG. 8B , FIG. 8C During this method of assembly, the top cap 14 will be secured after the material, whether cremated ashes, DNA, soil or other earthly materials such as sand, are placed in the open chamber 8 . The adaptable/adjustable jewelry container can be manufactured in any metal, such as but not limited to, all colors and karat weight of gold, silver or platinum, as well as brass or stainless steel and titanium. It may also be manufactured in all colors and types of plastics and resin products, as well as different types of wood. When the adaptable jewelry container is produced in wood, plastics or some other unmentioned material, the top cap 14 and bottom cap 16 will be sealed with a premium adhesive to secure the enclosed material in the container's chamber 8 . Some, but not limited to, uses for this type of assembly will be when incorporating this design in plaques, trophies, frames, paperweights, and costume jewelry. The adjustment in the depth of the cavity at the smaller bottom will still be possible in these materials. There may be times during manufacturing large quantities, where either the top cap 14 or bottom cap 16 will be pre-assembled or molded to its base counterpart for purposes of efficiency and to produce a cleaner product. It is to be understood that the above-described arrangements are only illustrative of the application of the principles of the present invention and are not to be construed as limitations of the invention. Numerous modifications and alternative arrangements may be devised by those skilled in the art without departing from the scope of the invention and the appended claims are intended to cover such modifications and arrangements. Further, the invention contemplates all embodiments that may be inferred directly or indirectly from the disclosure and drawings whether or not expressly stated and claimed.

A three part adaptable/adjustable jewelry container is presented for saving and preserving a small sample of ashes or other form of DNA material from either human or animals. The container may vary in size and shape to modify and enhance another separate piece of jewelry and may be attached by means of soldering the container, once completed, to the front, back, top, bottom or sides of the charm, bracelet, necklace, or ring, or other style of jewelry accompanying the container. The container can also be adjusted in height which will reduce the cavity where the ashes or DNA are kept, before the bottom cap is secured, to provide an air and water tight seal to insure the safety and integrity of the enclosed material. This will allow the completed container to accent and blend better with its other jewelry component, or in the case of standing alone as an independent piece of jewelry, the ability to lay flatter to the wearer.

[0001] This application claims the benefit of priority to Chinese patent application No. 201210494930.8 titled “POWER HANDPIECE FOR ORTHOPAEDIC DRILLING AND SAWING” and filed with the Chinese State Intellectual Property Office on Nov. 28, 2012, which is incorporated herein by reference in its entirety. TECHNICAL FIELD [0002] The present application relates to medical apparatus and instruments, particularly to a power handpiece for orthopaedic drilling and sawing and a power system for orthopaedic drilling and sawing with the power handpiece used in surgical operations. BACKGROUND [0003] Orthopaedic drilling and sawing operation are common surgical manners and are performed by an orthopaedic drilling and sawing device (for example, a handpiece). In the conventional technology, the orthopaedic drilling and sawing device generally has a handpiece structure, which includes a housing, a driving motor arranged in the housing, a clamping assembly, a control switch, and an accumulator for providing power source, and the handpiece structure is easy to operate and can perform drilling and sawing operations by switching a necessary switch. However, since the drilling and sawing device with such structure uses the accumulator, and the time of endurance of the accumulator is limited by the structure of the device. Thus, during the operation, the situation of power failure or low power is prone to occur, which affects the performing of the operation or even cause an accident. Moreover, due to the accumulator, the device not only generates a high quantity of heat which may destroy circuits, but also has a greater weight, thus it is difficult to operate, which indirectly reduces the efficiency of the operation. [0004] Therefore, it is required to improve the existing driving device (i.e. the handpiece) for orthopaedic drilling and sawing, to avoid the situation of power failure or low power which is prone to occur in the operation, and to ensure the smooth performance of the operation, reduce the quantity of heat of the handle, reduce the overall weight of the device, make the device portable and easy to operate, and improve the efficiency of the operation. SUMMARY [0005] In view of this, a power handpiece for orthopaedic drilling and sawing is provided according to the present application, to avoid the situation of power failure or low power which is prone to occur in the operation, and to ensure the smooth performance of the operation, reduce the quantity of heat of the handle, reduce the overall weight of the device, make the device portable and easy to operate, and improve the efficiency of the operation. On this basis, a power system for orthopaedic drilling and sawing having the power handpiece is further provided according to the present application. [0006] The power handpiece for orthopaedic drilling and sawing according to the present application at least includes a handle housing, a clamping assembly for clamping a cutting tool assembly, a power motor for outputting power and driving the cutting tool assembly to perform drilling and sawing operations, and a switch assembly for controlling power output of the power motor, wherein the power motor is connected to an external power source. [0007] Further, the power motor is connected to an external control system configured to control an operating state of the power motor by the switch assembly, and the control system is configured to drive the power motor to positively rotate, reversely rotate and reciprocately rotate via the switch assembly. [0008] Further, a rotor shaft of the power motor is an axially hollow rotor shaft, a transmission claw drivably connected to the cutting tool assembly is provided and is drivably connected to the rotor shaft, and the hollow rotor shaft is in communication with the transmission claw axially. [0009] Further, the switch assembly at least includes a button guide rod, a guide rod control mechanism and a button guide rod sensing member; [0010] two button guide rods are provided, and are arranged in respective guide rod seats, and the two button guide rods are reciprocately slidable along axes of the respective guide rod seats; a radial through hole is provided on a side wall of a guide channel of each of the guide rod seats, and the guide channel of the guide rod seat is configured to be passed through by the respective button guide rod, and a slidable roller is arranged in the radial through hole, a length of the radial through hole is smaller than a diameter of the roller, and the button guide rod is configured to be axially locked by sliding inwardly with the roller; [0011] the guide rod control mechanism includes a shifting block rotatable about an axis parallel to the button guide rods, the rollers of the two button guide rods are arranged to directly face to the shifting block, the shifting block is provided with two circumferential wave-shaped portions corresponding to the rollers, and the circumferential wave-shaped portions are configured to be driven by rotation of the shifting block to drive the rollers to slide along the respective radial through holes; [0012] the structure of the two circumferential wave-shaped portions are configured to drive the rollers at two sides thereof to simultaneously lock the respective button guide rods, to simultaneously release the respective button guide rods, or to lock one of the button guide rods and release the other of the button guide rods at one time; and [0013] the button guide rod sensing member is configured to collect movement signals of the two button guide rods and send the collected movement signals to the external control system. [0014] Further, the two button guide rods are symmetrically disposed at two sides of the shifting block, and the two circumferential wave-shaped portions are provided with crests which are radially opposite to each other, troughs which are radially opposite to each other, and a crest and a trough which are radially opposite to each other. [0015] Further, a guide rod bush is fixedly provided on the button guide rod axially, and a return spring is arranged between the guide rod seat and the guide rod bush to apply a return pretension force to the guide rod seat; a side wall of the guide rod bush is provided with an axial groove, a guide screw is radially screwed into the side wall of the guide channel of the guide rod seat to extend into the axial groove, and an axial bottom of the axial groove is a blind end abutting against the guide screw by the pretension force of the return spring; and the guide rod bush is provided with a locking recess for cooperating with the roller to axially lock the button guide rod. [0016] Further, the guide rod seats are fixedly arranged in a switch seat, a shifting block spindle is provided along an axis of the shifting block, and the shifting block spindle is arranged in the switch seat and is configured to rotatably cooperate with the switch seat; and [0017] the switch seat is hermetically fixed in the handle housing, the button guide rod extends inwardly to the handle housing and protrudes out of the respective guide rod seat, an end of the button guide rod that protrudes out of the guide rod seat is provided with a sensing head, and the button guide rod sensing member is a sensing circuit board which is located in the handle housing and fixedly connected to the switch seat, and is corresponding to the sensing head. [0018] Further, the handle housing is provided with a handheld portion, a cable seat configured for leading in a cable and restraining the same is fixedly connected to a tail end of the handheld portion, a lateral side of an outer surface of a front end of the cable seat is provided with a dovetail sunk platform, and an inner surface of the tail end of the handheld portion is provided with a dovetail sunk groove configured to be interlocked with the dovetail sunk platform; and another lateral side of the outer surface of the front end of the cable seat is fixedly connected to the tail end of the handheld portion via a screw. [0019] Further, the power motor is mounted in the handle housing, and a liner tube is coaxially arranged in the hollow shaft of the power motor; and a front end of a claw of the transmission claw has a triangular tooth-shaped structure. [0020] A power system for orthopeadic drilling and sawing according to the present application includes a host, a foot controller connected to the host, and a power handpiece for orthopeadic drilling and sawing connected to the host, wherein the power handpiece for orthopeadic drilling and sawing is the above-described power handpiece for orthopeadic drilling and sawing. [0021] The present application has the following beneficial effects. In the power handpiece for orthopeadic drilling and sawing according to the present application, the power machine utilizes an external power source which can be a large-scale accumulator or city electricity, thereby avoiding the situation of power failure or low power which is prone to occur in the operation, and ensuring the smooth performance of the operation, reduce the quantity of heat of the handle, reduce the overall weight of the device, make the device portable and easy to operate, and improve the efficiency of the operation. BRIEF DESCRIPTION OF THE DRAWINGS [0022] The present application is further described in conjunction with drawings and embodiments hereinafter. [0023] FIG. 1 is a schematic view showing the structure of a power handpiece for orthopaedic drilling and sawing according to the present application; [0024] FIG. 2 is a schematic view showing the structure of a switch assembly according to the present application; [0025] FIG. 3 is an enlarged view of part A in FIG. 2 ; [0026] FIG. 4 is a perspective view showing the structure of the switch assembly according to the present application; and [0027] FIG. 5 is a schematic view showing the overall structure of a power system for orthopaedic drilling and sawing. DETAILED DESCRIPTION [0028] The technical solutions in the embodiments of the present application will be described clearly and completely hereinafter in conjunction with the drawings in the embodiments of the present application. Apparently, the described embodiments are only a part of the embodiments of the present application, rather than all embodiments. Based on the embodiments in the present application, all of other embodiments, made by the person skilled in the art without any creative efforts, fall into the scope of the present application. [0029] Embodiments of the present application will be described in detail in conjunction with drawings. [0030] FIG. 1 is a schematic view showing the structure of the present application; FIG. 2 is a schematic view showing the structure of a switch assembly according to the present application; FIG. 3 is an enlarged view of part A in FIG. 2 ; and FIG. 4 is a perspective view showing the structure of the switch assembly according to the present application. [0031] As shown in the Figures, a power handpiece for orthopaedic drilling and sawing according to this embodiment at least includes a handle housing 1 , a clamping assembly 4 for clamping a cutting tool assembly, a power motor 2 for outputting power and driving the cutting tool assembly to perform drilling and sawing operations, and a switch assembly 5 for controlling the power output of the power motor 2 , wherein the power motor 2 is connected to an external power source. Generally, the cutting tool assembly includes a cutting tool, a cutting tool transmission component and a mounting clamping seat. The clamping assembly 4 is a part assembly for mounting the cutting tool assembly and may employ any conventional mechanical structures which can realize the clamping function. Since the cutting tools generally have universal clamping structures and may mostly use an elastic clamping structure as shown in the figure, wherein, a front-end roller locking mechanism is employed to fix various functional machine heads to realize a reliable connection, which belongs to the conventional technology, thus will not be described herein. [0032] In this embodiment, the power motor 2 is connected to an external control system configured to control an operating state of the power motor 2 by the switch assembly 5 . The control system is configured to drive the power motor 2 to rotate positively, rotate reversely and rotate reciprocately, via the switch assembly. With the external power source and the external control system and by setting an established process, the control system can control the power motor to achieve the above movements according to an instruction from the switch assembly, to adapt to actions required in an orthopedic surgery, thereby changing the current situation of single function and simple action in the conventional technology. The control system is a control unit having a central processing unit and can be achieved by an electrical automatic control structure in the conventional technology. [0033] In this embodiment, the power motor 2 has a rotor shaft which is an axially hollow rotor shaft, a transmission claw 3 drivably connected to the cutting tool assembly is provided and is drivably connected to the rotor shaft, and the hollow rotor shaft is in communication with the transmission claw 3 axially. With the structure of the hollow rotor shaft, the present application has a good universality and can be used for driving a longer cutting tool assembly such as a kirschner wire. Of course, the power handpiece in this solution can also drive various machine heads 40 of other forms, which include a horizontal swing saw machine head, a reciprocating saw machine head, a sternum saw machine head, a drill chuck, a reaming and filing machine head, a kirschner wire chuck and the like, thus a doctor can select various machine heads according to the requirement of an operation procedure, so as to achieve “one machine with multiple heads”, and requirements for most orthopedic surgeries can be satisfied by attaching various terminal cutting tools. [0034] In this embodiment, the switch assembly 5 at least includes a button guide rod 508 , a guide rod control mechanism and a button guide rod sensing member 509 . [0035] Two button guide rods 508 are provided, and are arranged in two guide rod seats 507 respectively, and the two button guide rods 508 are each reciprocately slidable along the axe of the respective guide rod seat 507 . A radial through hole 507 a is provided on a side wall of a guide channel of the guide rod seat 507 , and the guide channel of the guide rod seat 507 is configured to be passed through by the button guide rod 508 , and a slidable roller 506 is arranged in the radial through hole. A length of the radial through hole 507 a is smaller than a diameter of the roller 506 , and the button guide rod 508 can be axially locked by sliding inwardly with the roller 506 . The two button guide rods 508 of the switch assembly have the same structure as well as corresponding components thereof, thus are referred to with same reference numerals. [0036] The guide rod control mechanism includes a shifting block 513 rotatable about an axis parallel to the button guide rods 508 , the rollers 506 of the two button guide rods 508 are arranged to directly face to the shifting block 513 , the shifting block 513 is provided with two circumferential wave-shaped portions 513 a and 513 b corresponding to the rollers 506 , and the circumferential wave-shaped portions 513 a and 513 b are configured to be driven by rotation of the shifting block 513 to drive the rollers 506 to slide along the radial through holes 507 a. [0037] With the structure of the two circumferential wave-shaped portions 513 a, the rollers 506 at two sides of the circumferential wave-shaped portions are driven to simultaneously lock the respective button guide rods 508 , to simultaneously release the respective button guide rods 508 , or to lock one of the button guide rods 508 and release the other of the button guide rods 508 at one time. A sensing member of the button guide rods 508 is adapted to collect movement signals of the two button guide rods 508 and send the collected movement signals to an external control system. According to the collected movement signals of the two button guide rods 508 , the control system sends a rotation instruction to the power motor, to enable the power motor to have four operating states according to the movement signals of the button guide rods 508 , and the four operating states include a full locked state, a positive rotating state, a reverse rotating state, and a reciprocating rotating state, and in this way, the purpose of the present application is realized. The reciprocating movement of the two button guide rods can be controlled by the cooperation between the two circumferential wave-shaped portions 513 a and the rollers of the two button guide rods. Specifically, the full locked state is a state that crests of the two circumferential wave-shaped portions 513 a, 513 b simultaneously act on the rollers of the two button guide rods, and in this state, the two button guide rods 508 cannot move. The crest of one of the circumferential wave-shaped portions 513 a, 513 b acts on the roller of the respective button guide rod, thus this button guide rod is locked and cannot move, and a trough of the other of the circumferential wave-shaped portions 513 a, 513 b is aligned with the roller of the other button guide rod, thus this button guide rod is movable, in other words, the movement control system sends a signal to drive the power motor to positively rotate or reversely rotate, and vice versa. The full unlocked state is a state that the troughs of the two circumferential wave-shaped portions simultaneously act on the rollers of the two button guide rods, and in this state, the two button guide rods can be pressed at the same time and can move, to send a signal to the movement control system and drive the power motor to reciprocately rotate. Of course, procedures set in the control system are required to realize the above processes. [0038] In this embodiment, the two button guide rods 508 are symmetrically disposed at two sides of the shifting block, and the two circumferential wave-shaped portions 513 a, 513 b are provided with crests which are radially opposite to each other, troughs which are radially opposite to each other, and a crest and a trough which are radially opposite to each other. With such symmetrical structure, the switch assembly according to the present application has a compact structure, the circumferential wave-shaped portions of the shifting block are easy to produce, and the four operating states can be easily achieved. [0039] In this embodiment, a guide rod bush 503 is fixedly provided on the button guide rod 508 axially. As shown in the figures, the button guide rod 508 and the guide rod bush 503 are connected by a shaft pin 516 passing through the two members radially. A return spring 504 is arranged between the guide rod seat 507 and the guide rod bush 503 to apply a return pretension force to the guide rod seat. As shown in the figures, the return spring 504 is sleeved on the guide rod bush of the button guide rod 508 , and has two ends abutting against a bottom of the guide rod seat 507 and a step formed by an inner hole of the guide rod bush 503 , respectively. The guide rod bush 503 also functions as a spring seat of the button guide rod. A side wall of the guide rod bush 503 is provided with an axial groove 517 . A guide screw 505 is radially screwed into the side wall of the guide channel of the guide rod seat 507 to extend into the axial groove 517 . An axial bottom of the axial groove 517 is a blind end abutting against the guide screw 505 by the pretension force of the return spring 504 . The guide rod bush 503 is provided with a locking recess 503 a for cooperating with the roller 506 to axially lock the button guide rod 508 , i.e., the roller 506 moves radially to be embedded into the locking recess 503 a of the respective guide rod bush 503 , thereby axially locking the button guide rod 508 . As shown in the figures, a button 501 is provided to cooperate with the guide rod bush 503 , the button 501 is provided with a channel, thus the button 501 can be sleeved on the guide rod bush 503 , and the button 501 and the guide rod bush 503 are connected by a shaft pin 502 radially passing through the two members. [0040] In this embodiment, the guide rod seats 507 are fixedly arranged in a switch seat 511 . As shown in the figures, the switch seat 511 and the guide rod seat 507 are axially fixed by the guide screw 505 passing through the two members, and are tightly pressed by a pressing cover 515 to form a necessary fixed connection. Of course, the fixing manner can be any existing mechanical fixing manners which can achieve the fixing connection. A shifting block spindle 512 is provided along an axis of the shifting block 513 , and in this embodiment, the shifting block spindle 512 and the shifting block 513 are integrally formed. The shifting block spindle 512 is arranged in the switch seat 511 and is configured to rotatably cooperate with the switch seat 511 . As shown in the figures, the shifting block spindle 512 extends into a shaft hole formed in the switch seat 511 to rotatably cooperate with the switch seat 511 . The shifting block 513 is required to have a driving handle, and as shown in the figures, a shifting block driving handle 514 is provided and is fixedly connected to the shifting block spindle 512 in a circumferential direction. The shifting block driving handle 514 is symmetrical with respect to the axis of the shifting block spindle 512 , and has two ends forming driving ends respectively. In operation, the two driving ends can be driven by two fingers simultaneously, thus the shifting block can be operated stably. Of course, in order to increase the discontinuous feeling during driving the shifting block driving handle 514 and increase the hand feeling of the operator, the shifting block may be provided with a gear position structure and a spring, which belong to the conventional technology and will not be described herein. [0041] The switch seat 511 is hermetically fixed in the handle housing 1 . During the assembly, necessary sealing members are arranged, such as an O-ring, and are indicated in the figures, and these sealing members are conventional sealing structures which will not be described herein. The fixed connection can be achieved by a simple pin connection structure, and for example, a pin shaft 516 as shown in the figures is manufactured for the pin connection. The button guide rod 508 extends inwardly to the handle housing 1 and protrudes out of the guide rod seat 507 , an end of the button guide rod 508 that protrudes out of the guide rod seat 507 is provided with a sensing head 510 . The button guide rod sensing member 509 may be a sensing circuit board which is located in the handle housing 2 and fixedly connected to the switch seat 511 , and is corresponding to the sensing head 510 . The sensing head 510 and the sensing circuit board can employ existing normal structures to achieve the purpose, for example a proximity switch system (using magnetic induction, and etc.), a holl sensor system and the like, which belong to the conventional technology and will not be described herein. In other words, the button of the switch assembly can be controlled by the holl sensor, to steplessly regulate the control system to drive the power motor to positively rotate, reversely rotate and reciprocately rotate via the switch assembly. [0042] In this embodiment, the handle housing 1 is provided with a handheld portion 7 . A cable seat 6 configured for leading in a cable and restraining the same is fixedly connected to the tail end of the handheld portion 7 . A lateral side of an outer surface of a front end of the cable seat 6 is provided with a dovetail sunk platform, and an inner surface of the tail end of the handheld portion is provided with a dovetail sunk groove configured to be interlocked with the dovetail sunk platform. The other lateral side of the outer surface of the front end of the cable seat is fixedly connected to the tail end of the handheld portion via a screw 8 . With such interlocked dovetail pair structure, during the assembly, only one side is required to be fitted and the other side is fixed via one screw 8 , which is simple and easy to perform. [0043] In this embodiment, the power motor 2 is mounted in the handle housing 1 . A liner tube 11 is coaxially arranged in the hollow shaft of the power motor 2 , to prevent a high-speed friction between the inner hole of the hollow power shaft and the cutting tool deeply extending into the hollow shaft, such as the kirschner wire. A front end of a claw of the transmission claw 3 has a triangular tooth-shaped structure, and in assembly, such structure has a good adaptability with splines of the tail of the cutting tool, thus the assembly and transmission can be achieved without alignment. [0044] According to the above description of the structure and control principle, in the present application, under the control of the external power source and the external control system and in conjunction with the structure of the double-button switch, four operating states can be achieved, which include a full locked state, a positively rotating state, a reversely rotating state, and a reciprocating rotating state. Compared to the conventional technology, the present application has a small volume, a light weight and a small calorific value and can ensure that the smooth performance of the operation. Furthermore, the operating state can be regulated as desired, thereby facilitating the operation and ensuring therapeutic effect. [0045] Besides the above power handpiece for orthopaedic drilling and sawing, a power system for orthopaedic drilling and sawing having the power handpiece is further provided according to this embodiment. Reference is made to FIG. 5 , which is a schematic drawing showing the overall structure of the power system for orthopaedic drilling and sawing according to the present application. [0046] The power system for orthopaedic drilling and sawing includes a host 10 , a foot controller 20 connected to the host 10 , a power handpiece 30 for orthopaedic drilling and sawing connected to the host 10 , and respective machine heads 40 required for various functions. The power handpiece 30 for orthopaedic drilling and sawing is the above-described power handpiece for orthopaedic drilling and sawing. During the operation, the doctor can output a relevant operating instruction by the switch assembly 5 on the power handpiece for orthopaedic drilling and sawing, or output the same operating instruction by a foot switch on the foot controller 20 , and then control the operating state of the power motor 2 by the control system arranged on the host 10 . [0047] It should be noted that, specific configurations of the foot controller 20 and the host 10 can be achieved based on the conventional technology, thus will not be described herein. It should be appreciated that, any system using the power handpiece for orthopaedic drilling and sawing according to the present application falls in the scope of the present application. [0048] The embodiments described hereinabove are only preferred embodiments of the present application. It should be noted that, for the person skilled in the art, a few of modifications and improvements may be made without departing from the principle of the present application, and these modifications and improvements are deemed to fall into the scope of the present application.

The power handpiece for orthopaedic drilling and sawing according to the present application at least includes a handle housing, a clamping assembly for clamping a cutting tool assembly, a power motor for outputting power and driving the cutting tool assembly to perform drilling and sawing operations, and a switch assembly for controlling power output of the power motor, wherein the power motor is connected to an external power source. The power machine utilizes an external power source which can be a large-scale accumulator or city electricity, thereby avoiding the situation of power failure or low power which is prone to occur in the operation, and ensuring the smooth performance of the operation, reduce the quantity of heat of the handle, reduce the overall weight of the device, make the device portable and easy to operate, and improve the efficiency of the operation.

REFERENCE TO RELATED APPLICATION [0001] The present application is based on provisional application Ser. No. 60/618,512 filed Oct. 14, 2004 and provisional application Ser. No. 60/618,514 filed Oct. 14, 2004, the entire contents of which are herein incorporated by reference. BACKGROUND [0002] 1. Technical Field [0003] The present disclosure relates to biopsy forceps and, more specifically, to multiple biopsy forceps. [0004] 2. Description of the Related Art [0005] Endoscopy is the practice of looking inside the body of a subject for medical purposes. In modern endoscopy, a small scope called an endoscope is inserted into the subject, often, but not necessarily, through a natural opening. The endoscope may incorporate a viewing device such as a camera or suitable optics for viewing the interior of the subject. [0006] Examples of endoscopes include colonoscopes for examining the colon, gastroscopes for examining the stomach, and bronchoscopes for examining the bronchi. [0007] Mucosal biopsies may be obtained to assess the histology of the gastrointestinal tract. Biopsy forceps may be used for the execution of mucosal biopsy. The mucosal biopsy tissue sample may be, for example from 2 mm to 4 mm in diameter. [0008] Biopsy forceps may operate in conjunction with standard endoscopes and may be inserted through the working channel, engage the mucosa, and either cut or tear the sample from the surrounding tissue. Biopsy forceps may include means for removing and storing a biopsy sample. After the sample has been cut and stored, the biopsy forceps may be removed from the working channel and the specimen may be biopsied. In biopsy, samples may be stained, sliced and evaluated microscopically to evaluate the presence of disease, inflammation, and a host of other possible pathological responses. [0009] When taking multiple biopsy samples, repeated insertion and removal of the biopsy forceps from the working channel may increase the risk of complications such as perforation and/or patient discomfort. Moreover, repeated insertion and removal may compromise both procedure time and the precision of the topography covered by the diagnostic procedure. It is therefore desirable to utilize biopsy forceps that have the ability to remove and store multiple biopsy specimens. [0010] Traditional biopsy forceps may utilize a pair of jaws that may be made to simultaneously close around the biopsy specimen to cut and remove the specimen. These jaws have a limited range of motion that restricts the maneuverability of the biopsy forceps thereby complicating the removal of biopsy specimens at certain angles. It is therefore desirable to utilize biopsy forceps that have the ability to remove biopsy samples from greater angles. [0011] One example of traditional biopsy forceps is German Patent Specification DE 43 19 968 C1, Mondrowski. Mondrowski relates to a biopsy forceps described as a tubular shaft instrument. Mondrowski utilizes a cutting jaw that appears capable of opening to an acute angle and cutting in a scissor-like fashion as the jaw closes. In Mondrowski, the jaw is attached to a toothed sector which engages with a toothed rack and the opening and closing of the jaw is achieved by actuating the toothed rack. Because Mondrowski only appears capable of opening to an acute angle and because Mondrowski cuts in a scissor-like fashion, Mondrowski suffers from the same shortcoming of the prior art discussed above. Specifically, Mondrowski has a limited range of motion that restricts the maneuverability of the biopsy forceps thereby complicating the removal of biopsy specimens at certain angles. SUMMARY [0012] An apparatus for excising tissue samples includes a flexible cylinder member for insertion into a working channel. The apparatus also includes a ridged cylinder member connected to the top of the flexible cylinder member. The apparatus also includes one or more guide channels running through the flexible cylinder member and the ridged cylinder member, the one or more guide channels guiding one or more pull wires. The apparatus also includes a hatch connected to the ridged cylinder member via a hinge such that the hatch may open to an angle up to 180 degrees of horizontal. The one or more pull wires attach to or wrap around the hatch such that actuation of the one or more pull wires closes the hatch. [0013] An apparatus for excising tissue samples includes a stationary frame. The apparatus also includes a pinion casing with a pinion axel mounted on the stationary frame. The apparatus also includes a pinion rotatable mounted within the pinion casing and about the pinion axel. The apparatus also includes a swinging frame ridgedly connected to the pinion such that as the pinion rotates, the swinging frame swings between a proximal closed position and a distal open position. The apparatus also includes a rack interlocking with the pinion for causing the pinion to rotate. The apparatus also includes an actuator rod connected to the rack for actuating the rack and a pusher connected to the actuator rod or rack for pushing an excised tissue sample into a depository chamber. When the swinging frame is in the proximal closed position, the tissue sample may be excised and as the swinging frame is sent to the distal open position by rod actuation, the excised tissue sample is carried by the swinging frame to the distal side of the frame where it is pushed, by the pusher, into the depository chamber. [0014] An apparatus for excising tissue samples includes a depository chamber for accommodating multiple tissue samples. The depository chamber has differential friction such that the degree of friction experienced by the excised tissue samples moving in a direction into the depository chamber is less than the degree of friction experienced by the excised tissue samples moving in a direction out of the depository chamber. [0015] An apparatus for excising tissue samples includes a depository chamber for accommodating multiple tissue samples, the depository chamber includes negative pressure for sucking excised tissue samples into the depository chamber. The depository chamber also includes a slanted and perforated septum for keeping the excised tissue samples within a confined area within the depository chamber. [0016] A method for excising a tissue sample from an excision site comprising the steps of cutting the tissue sample from the excision site using a blade attached to an open frame as the tissue sample protrudes from a hole in the open frame, and transporting the severed tissue from the excision site to a collecting chamber while the tissue sample rests on an outer surface of the open frame. BRIEF DESCRIPTION OF THE DRAWINGS [0017] A more complete appreciation of the present disclosure and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein: [0018] FIG. 1A is a diagram of a biopsy forceps according to one embodiment of the present invention; [0019] FIG. 1B is a diagram of a biopsy forceps according to embodiments of the present invention where only a single pull wire is used; [0020] FIG. 1C is a diagram of a biopsy forceps according to embodiments of the present invention where the rim of the ridged cylinder slopes down at an angle; [0021] FIG. 2 is a diagram of a biopsy forceps according to embodiments of the present invention utilizing a rack and pinion pivot design; [0022] FIG. 3 is a diagram showing the biopsy forceps of FIG. 2 , in the open position; [0023] FIG. 4 is a diagram showing the biopsy forceps of FIGS. 2 and 3 , returned to the closed position; [0024] FIG. 5 is a diagram showing the biopsy forceps of FIGS. 2, 3 and 4 with a collecting chamber; [0025] FIG. 6A is a diagram showing the biopsy forceps of FIGS. 2, 3 , 4 and 5 with a pusher according to an alternative embodiment of the present invention; [0026] FIG. 6B is a close-up perspective view of the pusher of FIG. 6A ; [0027] FIG. 7 is a diagram showing an example of a differential friction collecting chamber/catheter according to an embodiment of the present invention; and [0028] FIG. 8 is a diagram showing a depository chamber according to another embodiment of the present invention. DETAILED DESCRIPTION [0029] An apparatus for excising tissue samples includes a flexible cylinder member for insertion into a working channel, a ridged cylinder member connected to the top of the flexible cylinder member, one or more guide channels running through the flexible cylinder member and the ridged cylinder member and a hatch connected to the ridged cylinder member via a hinge. The guide channels guides one or more pull wires. The hatch may open to an angle up to 180 degrees of horizontal. The pull wires attach to or wrap around the hatch such that actuation of the one or more pull wires closes the hatch. [0030] The apparatus may additionally include a bladed or serrated cutting surface formed on the hatch and/or on the ridged cylinder end facing the hatch for facilitating the excision of the tissue sample. [0031] A single guide channel may run through the flexible cylinder member and the ridged cylinder member. The single guide channel guides a single pull wire. The single pull wire runs through a guide channel in the hatch and connects to the ridged cylinder member. As the single pull wire is actuated, the hatch closes. [0032] Two guide channels may run through the flexible cylinder member and the ridged cylinder member. The two guide channels guide two pull wires. The two pull wires connect to the hatch such that as the two pull wires are actuated, the hatch closes. The hinge may be spring loaded or comprised of a memory material that biases the hatch to the open position. The pull wires may have a memory shape bowing out at a segment between the hatch and a rim of the ridged cylinder member allowing for the excision of larger tissue samples. The top of the ridged cylinder member may be angled resulting in a larger opening for accommodating larger tissue samples. Excised tissue samples may be guided into a depository chamber within the ridged cylinder member by the closing of the hatch. The depository chamber may be able to accommodate multiple excised tissue samples. [0033] An apparatus for excising tissue samples includes a stationary frame, a pinion casing with a pinion axel mounted on the stationary frame, a pinion rotatable mounted within the pinion casing and about the pinion axel, a swinging frame ridgedly connected to the pinion such that as the pinion rotates, the swinging frame swings between a proximal closed position and a distal open position. A rack interlocks with the pinion for causing the pinion to rotate. An actuator rod connected to the rack actuates the rack. A pusher connected to the actuator rod or rack pushes an excised tissue sample into a depository chamber. The tissue sample is excised when the swinging frame is sent to the proximal closed position. When the swinging frame is sent to the distal open position by rod actuation, the excised tissue sample is carried by the swinging frame to the distal side of the frame where it is pushed, by the pusher, into the depository chamber. [0034] A bladed or serrated cutting surface may be formed on the proximal side of the frame for facilitating the excision of the tissue sample. A hole may be formed on the proximal side of the swinging frame such that as the swinging frame is sent to the closed position and the tissue sample is excised, the swinging frame closes against the stationary frame and the tissue sample is pushed through the hole in the swinging face so that as the swinging frame opens the tissue sample may be pushed by the swinging frame. The swinging frame may swing as much as 180 degrees as it moves between the proximal closed position and the distal open position. The depository chamber may be able to accommodate multiple excised tissue samples. [0035] An apparatus for excising tissue samples includes a depository chamber for accommodating multiple tissue samples. The depository chamber has differential friction such that the degree of friction experienced by the excised tissue samples moving in a direction into the depository chamber is less than the degree of friction experienced by the excised tissue samples moving in a direction out of the depository chamber. [0036] The apparatus may further include a flexible cylinder member for insertion into a working channel, a ridged cylinder member connected to the top of the flexible cylinder member, one or more guide channels running through the flexible cylinder member and the ridged cylinder member, the one or more guide channels guiding one or more pull wires, and a hatch connected to the ridged cylinder member via a hinge such that the hatch may open to an angle up to 180 degrees of horizontal. The pull wires attach to or wrap around the hatch such that actuation of the one or more pull wires closes the hatch thereby excising a tissue sample and moving the excised tissue sample into the depository chamber. [0037] The apparatus for excising tissue samples may further include a stationary frame, a pinion casing with a pinion axel mounted on the stationary frame, a pinion rotatable mounted within the pinion casing and about the pinion axel, a swinging frame ridgedly connected to the pinion. As the pinion rotates, the swinging frame swings between a proximal closed position and a distal open position. The apparatus for excising tissue samples may further include a rack interlocking with the pinion for causing the pinion to rotate, an actuator rod connected to the rack for actuating the rack, and a pusher connected to the actuator rod or rack for pushing an excised tissue sample into the depository chamber. When the swinging frame is sent to the proximal closed position, the tissue sample may be excised and when the swinging frame is sent to the distal open position by rod actuation, the excised tissue sample is carried by the swinging frame to the distal side of the frame where it is pushed, by the pusher, into the depository chamber. [0038] The inner surface of the depository chamber may be lined with one or more micro flaps. The micro flaps may be attached to a cord and the cord is mounted to the inside surface of the depository chamber. The micro flaps may be laser etched into the inside surface of the depository chamber. Tissue samples may be removed from the depository chamber by pushing the tissue samples through the depository chamber using a plunger. [0039] An apparatus for excising tissue samples includes a depository chamber for accommodating multiple tissue samples. The depository chamber includes negative pressure for sucking excised tissue samples into the depository chamber and a slanted and perforated septum for keeping the excised tissue samples within a confined area within the depository chamber. [0040] The apparatus may further include a flexible cylinder member for insertion into a working channel, a ridged cylinder member connected to the top of the flexible cylinder member, one or more guide channels running through the flexible cylinder member and the ridged cylinder member, the one or more guide channels guiding one or more pull wires, and a hatch connected to the ridged cylinder member via a hinge such that the hatch may open to an angle up to 180 degrees of horizontal. The pull wires attach to or wrap around the hatch such that actuation of the one or more pull wires closes the hatch thereby excising a tissue sample and moving the excised tissue sample into the depository chamber. [0041] The apparatus for excising tissue samples may further include a stationary frame, a pinion casing with a pinion axel mounted on the stationary frame, a pinion rotatable mounted within the pinion casing and about the pinion axel, a swinging frame ridgedly connected to the pinion such that as the pinion rotates, the swinging frame swings between a proximal closed position and a distal open position, a rack interlocking with the pinion for causing the pinion to rotate, an actuator rod connected to the rack for actuating the rack, and a pusher connected to the actuator rod or rack for pushing an excised tissue sample into the depository chamber. When the swinging frame is sent to the proximal closed position, the tissue sample may be excised and when the swinging frame is sent to the distal open position by rod actuation, the excised tissue sample is carried by the swinging frame to the distal side of the frame where it is pushed, by the pusher, into the depository chamber. [0042] The septum may be contoured. The septum may be convex. The septum may be concave. The septum may be planar. The planar septum may be angled between perpendicular and parallel to a central axis of the depository chamber in any direction. The planar septum may be angled 45 degrees from perpendicular to the central axis of the depository chamber in any direction. [0043] A method for excising a tissue sample from an excision site includes cutting the tissue sample from the excision site using a blade attached to an open frame as the tissue sample protrudes from a hole in the open frame, and transporting the severed tissue from the excision site to a collecting chamber while the tissue sample rests on an outer surface of the open frame. [0044] In describing the preferred embodiments of the present disclosure illustrated in the drawings, specific terminology is employed for sake of clarity. However, the present disclosure is not intended to be limited to the specific terminology so selected, and it is to be understood that each specific element includes all technical equivalents which operate in a similar manner to achieve similar results. [0045] FIG. 1A is a diagram of a biopsy forceps according to one embodiment of the present invention. The biopsy forceps 10 has a flexible cylinder section 11 which may be sufficiently long and flexible to be guided to the desired location within the subject's body. Connected to the flexible cylinder section 11 may be a ridged cylinder section 12 . The ridged cylinder section 12 may provide structural stability useful to support the biopsy features. One or more guide channels 14 , for example two guide channels 14 , may be mounted within the ridged cylinder section 12 and the flexible cylinder section 11 . Alternatively, the guide channels 14 may be mounted along the outside of the cylinder sections 11 and 12 , or integrated into the wall of the cylinder sections 11 and 12 . The guide channels 14 allow for the unimpeded movement of one or more, for example two, pull wires 15 within the guide channels 14 . The pull wires 15 may be actuated either manually or with a powered actuator. The pull wires 15 may be used to draw in a hatch 13 . The pull wires may be attached to the hatch 13 and/or a single pull wire may travel over the external surface of the hatch 13 . When the pull wires are actuated, the hatch may close around the biopsy tissue. The hatch 13 may be a flat hatch or it may be cup-shaped. A hinge 16 may be used to connect the hatch 13 to the ridged cylinder section 12 . The hinge 16 may be spring-loaded or may be constructed of a memory-material which may provide a bias for keeping the hinge 16 in the open position. A cutting surface 17 may be incorporated into the hatch 13 to facilitate the excision of the biopsy sample tissue. The cutting surface may be either bladed or serrated. The combination of the cutting surface and the closing of the hatch may accomplish the severing of the tissue. [0046] Actuation of the pull wires 15 may be used to pull the hatch 13 completely closed and/or to position the hatch 13 and its cutting surface 17 to a desired angle to facilitate excision of the tissue. The novel design described above may allow for the hatch 13 to open as much as 180 degrees from the closed position. Because the hatch 13 may function as a cutting surface, the ability to open to either an acute, right or obtuse angle provides the forceps, according to embodiments of the present invention, the ability to more easily and more accurately excise tissue from a wide variety of approach vectors. [0047] The pull wire may have a memory shape bowing out at the segment between the hatch and the rim of the ridged cylinder. This bowing out may allow for more tissue to be excised. [0048] FIG. 1B is a diagram of a biopsy forceps according to embodiments of the present invention where only a single pull wire 15 is used. The wire may leave the guide channel 14 on the external surface of the ridged cylinder 12 , just below its rim. The wire may then travel over the hatch through a short channel 18 made within the external surface of the hatch 13 . The wire may then be connected to the ridged cylinder 12 , for example, at a location 19 at the opposite point of the rim from where the guide channel 14 is located. [0049] In this way, a single guide wire may be used to actuate the hatch in a symmetric fashion. [0050] As the hatch closes, the excised tissue may be pushed into the ridged cylinder. A flat hatch may be used to facilitate the pushing of the tissue into the cylinder. [0051] FIG. 1C is a diagram of a biopsy forceps according to embodiments of the present invention where the rim of the ridged cylinder 12 slopes down at an angle, for example 45 degrees from horizontal. Such sloping may serve to increase the size of the opening of the ridged cylinder 12 so that larger tissue samples may be accommodated. In such embodiment, the hatch may swing inwards to a greater distance to meet flush with the rim of the ridged cylinder. [0052] Other embodiments of the present invention utilize a rack and pinion pivot design to excise and transfer a tissue sample into a depository chamber. FIG. 2 is a diagram of a biopsy forceps according to embodiments of the present invention utilizing a rack and pinion pivot design. The base of the biopsy forceps 20 is a base clevis component, anvil or stationary frame 21 . On the stationary frame 21 , for example on the center or proximally, is a pinion casing 25 having an axle (not shown). Within the pinion casing 25 is a pinion 28 that rotates about the axle. Attached to, and actuated by, the pinion 28 is a swinging frame 27 with a center hole. The swinging frame 27 may have a cutting element 26 that may be located on the tip of the swinging frame 27 and/or within the center hole of the swinging frame. The swinging frame 27 may contact the stationary frame 21 when the biopsy forceps is in the closed position, as shown in FIG. 2 . In actuating the swinging frame 27 into the closed position, the cutting element 26 can be used to shave or cut the desired tissue sample 29 . To facilitate this excision, the cutting element 26 may be bladed or serrated. [0053] The cutting action may be achieved, for example, by the swinging frame 27 closing completely against the stationary frame, for example, with the cutting element 26 positioned on the front-underside of the swinging frame so that the tissue sample is severed in a cookie cutter style. Alternatively, or additionally, the cutting element 26 may be positioned within the center hole of the swinging frame, for example angled downwards and inwards, so that the biopsy forceps 20 may be pulled away from the excision site to complete the severance. [0054] After the biopsy forceps in the closed position has been used to excise the desired tissue sample 29 , the tissue sample 29 may be pushed through the opening in the swinging frame by the closing force so as to rest on the top of the swinging frame 27 . [0055] An actuator rod or rigid wire 23 may be attached to a rack 22 . The rod 23 and rack 22 may sit on the stationary frame 21 and the rack 22 may interlock with the pinion 28 such that as the rod 23 is pushed forward, the pinion 28 rotates thereby rotating the swinging frame 27 about the pinion 28 . [0056] Due to the tackiness of the tissue sample 29 , the tissue sample 29 may remain attached to the swinging frame 27 as it travels, up to 180 degrees from the closed position to the open position. FIG. 3 shows the biopsy forceps of FIG. 2 in the open position. In this state, the tissue sample 29 is moved to the rod 23 . A pusher 24 , for example a metal retriever component, attached to the rod 23 is placed such that it abuts the tissue sample 29 as it is brought down from the swinging frame 27 . [0057] FIG. 3 also shows a raised bump 30 and a curved spike 31 . The raised bump 30 may be formed on the front portion of the stationary frame 21 . The raised bump may be of any size or shape but should not be larger than the footprint of the hole in the swinging frame 27 as it rests in the closed position shown in FIGS. 2 and 4 . The raised bump 30 may help to push the tissue sample upwards so that the tissue sample protrudes through the hole on the swinging frame 27 as the swinging frame closes to sever the tissue sample. Having the tissue sample protrude through the swinging frame may be useful to minimize the likelihood that the tissue sample does not properly disengages from the swinging frame as the tissue sample is pushed into a depository chamber as discussed below. Having the tissue sample protrude through the swinging frame may also be useful to provide leverage so that the tissue sample may be more easily severed, for example, by a blade positioned within the hole of the swinging frame as the biopsy forceps 20 is pulled away from the tissue excision site. [0058] The curved spike 31 may be used in conjunction with the raised bump or in place of the raised bump. The curved spike may be uniformly thin and wire-like or it may widen at the base and form the bump 30 . The curved spike 31 may be curved to match an arch traced by the tissue sample as it is carried from the excision site to the collecting chamber. Such a curvature will minimize resistance attributable to the spike as the tissue sample is lifted. The curved spike may minimize the chances of the tissue sample moving out of place as the sample excised and as the sample is pushed through the center hole of the swinging frame. [0059] As the rod 23 is pulled back and the biopsy forceps 20 move back into the closed position to remove the next tissue sample, the pusher 24 pushes the tissue sample 29 off of the swinging frame 27 and into a depository chamber (not shown), such as a ridged cylinder, that may be placed on the frame 21 . FIG. 4 shows the biopsy forceps of FIGS. 2 and 3 returned to the closed position. [0060] Unlike the jaw of Mondrowski, whose mobility appears to be limited to acute angles, the swinging frame 27 of embodiments of the present invention may be open to any angle between 0 and 180 degrees of horizontal to initiate cutting of the tissue sample. Additionally, unlike Mondrowski where the sample must be cut in one direction and then pushed in the same direction for collection, embodiments of the present invention allow for the sample to be cut in one direction and then pushed in the opposite direction for collection. This approach allows for greater flexibility. [0061] Although embodiment of the present invention may be of any size small enough to safely enter the working channel, according to some embodiments of the present invention, the outer diameter of the biopsy forceps may be 2.8 mm or 3.2 mm. [0062] Endoscopic biopsy forceps according to embodiments of the present invention may be used to store multiple tissue samples in a depository chamber so that the endoscope does not need to be removed and reinserted. [0063] According to one embodiment of the present invention, the depository chamber may employ a differential friction collecting chamber/catheter concept. According to this concept, there is greater friction in moving the sample out of the depository chamber than in pushing it in. Therefore, when a sample is pushed into the depository chamber, for example by using a pusher 24 as seen in FIG. 4 , the sample may be easily pushed into the depository chamber but is unlikely to remain tacked to the pusher as the pusher pulls away. [0064] FIG. 5 is a diagram showing the biopsy forceps of FIGS. 2, 3 and 4 shown with a collecting chamber 51 . The collecting chamber may be, for example, one of the collecting chambers shown in FIGS. 8 and 9 and described in detail below. The collecting chamber may be positioned such that it is as close to the tissue sample as possible without obstructing the motion of the swinging frame. By placing the collecting chamber close to the tissue sample, the risk of accidental loss of the tissue sample is minimized. Additionally, one or more side walls 52 may be used to further minimize the risk of loss of the tissue samples. The side walls may be formed as an integral unit with the collecting chamber and may be rectangular (as shown) or contoured to further minimize risk of loss. For example, the collecting chamber and side walls may be formed by removing a shaped section of the top of the collecting chamber just large enough to allow the swinging frame to come down unimpeded. [0065] The pusher 24 ( FIG. 4 ) may alternatively comprise two or more posts or wires so that the tissue sample may be more pushed with greater stability. Alternatively, the pusher may be a pusher wall rather than a post or wire. The pusher should be able to push on the tissue sample but should not be positioned such that the tissue sample is impaled upon the pusher as the tissue sample is brought down by the swinging frame. To minimize the chances that an irregularly shaped tissue sample is accidentally impaled upon the pusher, the tip(s) of the pusher may be blunt, for example, rounded. According to one embodiment of the present invention, the pusher forms a pusher basket so that as the tissue sample is pushed, the chances of the tissue sample being lost are minimized. FIG. 6A is a diagram showing the pusher basket according to this embodiment of the present invention. The pusher basket 61 may comprise side structures to minimize the chances of the tissue sample being lost. FIG. 6B is a close-up perspective view of the basket pusher 61 shown in FIG. 6A . [0066] FIG. 7 is a diagram showing an example of a differential friction collecting chamber/catheter according to an embodiment of the present invention. According to this example 70 , one or more micro flaps 72 may be positioned on the inside walls of the depository chamber 71 . Then, as tissue samples 75 are pushed into the depository chamber 71 , for example by a pusher 24 , the samples 75 may easily move inwards. However, as the pusher 24 moves away, the micro flaps make it unlikely that a tissue sample 75 will remain tacked to the pusher 24 resulting in the loss of a tissue sample. [0067] Many different techniques could be used to produce the micro flaps. For example, micro flaps may be attached to a fishing cord-like material that is then glued into the collecting chamber. Alternatively, laser etching techniques may be used. For example, the walls of the collecting chamber may be etched with a series of angled groves to produce the micro flap effect. Although the micro flaps shown in FIG. 7 appear as long wires, the micro flaps may be very small with respect to the diameter of the collecting chamber. The micro flaps need not be so large that they reduce the maximum size of a tissue sample that can easily be stored within the collecting chamber. [0068] When the endoscope is removed, the samples may be freed from the depository chamber with the help of a plunger that can push the samples all the way through the endoscope. Alternatively, the depository chamber may form a detachable section of the endoscope, which can be separated to avoid pushing samples all the way through the endoscope. Alternatively, a side hole may be present in the collecting chamber for the removal of collected samples. [0069] FIG. 8 is a diagram showing a depository chamber 80 according to another embodiment of the present invention. According to this embodiment, negative pressure (suction) 83 is provided to the chamber tube 81 . A slanted and perforated septum 82 is positioned within the depository chamber tube 81 . The septum 82 ensures collected tissue samples 84 stay confined within the depository chamber 80 . By slanting the septum 82 , the septum surface area can be increased thereby allowing for more samples to be collected and reducing the likelihood that the septum can become impacted with samples thereby blocking suction within the depository chamber. [0070] Additionally, the slanted septum may allow the first samples to enter the chamber to roll to the “top” of the chamber (that area where the space between the septum and the chamber tube is the smallest). This may cause the suction to redistribute further down the septum to the unoccupied area. [0071] The septum may be flat. Alternatively, the septum may be shaped. For example, the septum may be concaved forming a cone-shape or convex forming an inverted cone shape. The septum may have any number of perforations. For example, the septum may have 4 holes for accommodating 4 samples, or it may have a large number of holes for accommodating a large number of samples. [0072] The above specific embodiments are illustrative, and many variations can be introduced on these embodiments without departing from the spirit of the disclosure or from the scope of the appended claims. For example, elements and/or features of different illustrative embodiments may be combined with each other and/or substituted for each other within the scope of this disclosure and appended claims.

A method and apparatus for mucosal biopsy including a stationary base clevis component, upon which an open frame jaw is actuated rotationally to engage tissue and retract samples. A rack and pinion mechanism drives the jaw motion, which can be controlled axially by the physician. A metal retriever component captures tissue from the open frame jaw, and advances the samples proximally into the collection chamber, where they are maintained as the retriever is returned to its most distal position. Furthermore, the open frame design employs a reliable and compact means for actuation that can be decoupled from sample transfer and storage functions.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to medical devices that transmit laser energy. Specifically, the present invention relates to fiber optic laser energy delivery devices that emit a laser beam substantially laterally relative to the longitudinal axis of the fiber optic in a liquid medium. 2. Description of the Prior Art In conventional laser energy delivery devices, a laser beam is emitted from the distal end of one or more optical fibers toward the point of application in the human body. Medical applications of lasers, such as in urology, gynecology, general surgery, orthopedics, ophthalmology and other surgical procedures, sometimes require laser energy to be emitted laterally from the axis of the optical fiber, so that, in urological applications for example, the lateral lobes of the prostate may undergo ablation and/or coagulation to create an enlarged region or passage for an enhanced fluid flow. A prism can be used to laterally reflect light energy, so long as the index of refraction of the medium surrounding the reflective surface of the prism is substantially lower than the index of refraction of the prism itself, provided the reflective surface of the prism is at or below the critical angle for total internal reflection. This critical angle depends on the ratio of the respective refractive indices between the material of the prism and that of the environment or adjoining substance immediately outside the prism's reflective surface (i.e., the boundary interface). In order to achieve total internal reflection, for a given lateral reflection angle, a substance such as air (with a refractive index of about 1) can be used to assure a sufficiently low refractive index relative to that of a glass prism (refractive index 1.46). As a result, glass prisms function properly in an air environment. However, in water (refractive index 1.33) or in saline (refractive index about 1.33, depending on concentration), glass prisms do not effectively reflect light energy laterally substantially close to 90 degrees because the difference in refractive indices between the glass and the ambient medium is not great enough. Moreover, surrounding the prism with air has disadvantages. One such disadvantage is that an enclosure transparent to the wavelength of energy being used, such as a glass encapsulating sleeve, is needed to contain and maintain an air environment at the prism interface. This, in turn, requires that the prism be positioned in precise orientation within the sleeve. To achieve this, a very tedious alignment procedure, difficult to accurately replicate in production, is involved. On the other hand, if the prism is not in precise alignment, internal reflection may not be achieved, or a laser beam in an errant direction may be emitted. Affixation of the glass encapsulating sleeve to the buffer coating or cladding of an optical fiber in an airtight manner is also difficult to assure in production. Another problem with a glass sleeve is that an output power loss of five to ten percent may be experienced due to scattering and back reflection from the sleeve. This is a significant and undesirable power loss. In surgical devices that come in contact with tissue it is also difficult to maintain the glass encapsulating sleeve at a sufficiently low temperature to prevent tissue from sticking thereto. If this happens, the temperature of the sleeve can quickly rise to the point of destruction, with the potential for leaving fragments of the glass sleeve in the body, which might necessitate surgery to remove them. Still another problem with the glass encapsulating sleeve is that it is fragile. Physical stresses exerted during insertion through endoscopes or guiding catheters, or during the lasing procedure could cause the sleeve to break, leaving glass fragments at the medical procedure site and causing complications to the patient that might require an invasive surgical procedure to correct. While laser energy may be laterally reflected from a polished metal surface in a fluid medium, some of the laser energy may be absorbed by the metal surface, thereby raising its temperature. If the metal surface is contaminated by tissue or body oils, the temperature of the metal surface can rapidly increase, causing the metal to deteriorate or melt. Therefore, it would be desirable to have a medical device that reflects the laser energy laterally in a fluid medium without the need for a metal reflecting surface or glass encapsulating sleeve. The present invention provides such a device. SUMMARY OF THE INVENTION A laser energy delivery catheter for lateral transmission of laser energy in a liquid medium is contemplated by the present invention. Laser energy is transmitted through an optical fiber to a prism with a relatively high index of refraction relative to the surrounding liquid medium. Within the prism, laser energy is reflected from a beveled reflecting surface of the prism and directed laterally. A liquid interface between the distal end of the optical fiber and the proximal end of the prism is provided to reduce laser energy coupling losses at the interface when the device is in use. A device embodying the present invention provides increased efficiency and reliability since there is no need for a glass encapsulating sleeve. The liquid medium that surrounds the prism when the device is in use also cools the distal end of the optical fiber, the prism, and the tissue at the site of the medical procedure. The present invention also provides for distinct advantages in manufacturability. The prism, instead of a triangular shape that is difficult to mount and orient inside a needle, cannula or housing, can be cut from a block of a material having a relatively high refractive index, such as silica doped with lead, barium, sodium, titanium, and other oxides, for example, SFL-57 from Schott Glass Technologies, Inc, Duryea, Pa., with a refractive index of 1.811 at 1060 microns, or synthetic sapphire, which has refractive index of 1.745 at 1060 microns, into an elongated, transparent rod having a rectangular cross section. The distal surface of the rod can be inclined at an angle or angles consistent with the critical angle required to provide total internal reflection of the incident radiant energy in a liquid medium laterally from the longitudinal axis of the catheter. When a transparent rod with a prism-shaped distal end is inserted into a matching recess in a housing, orientation of the prism relative to the fiber optic can be positively and easily controlled. A catheter embodying the present invention includes an elongated, substantially cylindrical housing that defines a recess for a prism or "rod bearing prism", a confined flow passageway for a liquid medium, a sidewall aperture, a prism mounted in the housing, and a fiber optic positioned to deliver laser energy to the prism. The distal end of the fiber optic is also mounted in the cylindrical housing, and the proximal end of the fiber optic is adapted for coupling to a laser source. The prism may abut or be spaced from the distal end of the fiber optic and is positioned to receive a laser beam emitted by the fiber optic at its distal end, and to direct the emitted beam outwardly through the sidewall aperture in the housing. The refractive index of the prism is higher than that of the fiber optic and of the liquid medium that serves to optically couple the fiber optic to the prism as well as to cool the prism while the catheter is in use. Use of a liquid between the emitting surface of the fiberoptic and the receiving surface of the prism substantially reduces the reflection losses therefrom. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, FIG. 1 is a perspective view showing the distal end of a laser energy delivery catheter embodying the present invention; FIG. 2 is a partially exploded perspective view of the device shown in FIG. 1; FIG. 3 is a further exploded perspective view of the device shown in FIG. 1; FIG. 4 is a side elevational view showing the device of FIG. 1 in section; FIG. 5 is a plan view showing the device of FIG. 1 in section; FIG. 6 is a sectional view taken along plane 6--6 in FIG. 4; FIGS. 7(a) and 7(b) illustrate alternative prism configurations; FIG. 8 illustrates a ray trace for the fiber and the high index prism; FIG. 9 illustrates a prism similar to that of FIG. 8 but with the addition of a collimating lens on the input surface; FIG. 10 illustrates a prism similar to that of FIG. 8 but with a recess in the input surface of the prism adapted to receive the distal end of a fiber optic; FIG. 11 illustrates another embodiment of the current invention; FIG. 12 shows an embodiment similar to that of FIG. 11 but with the addition of forced coaxial irrigation; FIG. 13 shows the cross sectional view taken at plane 13--13 in FIG. 12; FIG. 14 shows another embodiment of a suitable high index prism; FIG. 15 is a side elevational view of the prism utilized in the embodiment shown in FIG. 11; and FIG. 16 is a side elevational view of an alternate prism that can be used in practicing the present invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS The present laser delivery catheter can be used in a body lumen, organ, cavity or a surgically created passageway, where it is advantageous to apply laser energy laterally relative to the catheter's longitudinal axis. The present device is suitable for coagulating, cutting or ablating tissue, cartilage or other substances. Accordingly, the present device has utility in medical applications, such as urology, gynecology, general surgery, orthopedics, ophthalmology and other surgical procedures. Referring to the drawings, FIG. 1 shows a catheter distal end 10 which is a substantially cylindrical housing constituted by frame 12 and hollow cap 14. Frame 12 is mounted to flexible tubing 16, through which optical fiber 20 extends. Hollow cap 14 is provided with sidewall aperture 18. Hollow cap 14 together with frame 12 and tubing 16 define a housing or recess for the prism and optical fiber 20, as well as a confined flow passageway for a liquid medium, such as water or saline, that may also serve as an optical coupling medium as well as a cooling medium and/or irrigation medium when the catheter embodying the present invention is in use. The flow of liquid medium (i.e., water or saline) through the catheter housing and out through sidewall aperture 18 is indicated by series of connected arrows. Referring to FIGS. 2 and 3, frame 12 is a hollow, apertured tubular member having a cylindrical body portion 22, collar 24 that surrounds body portion 22 at one end thereof, and grips or leafs 26 and 28 that extend away from collar 24 toward the distal end of the catheter. Leafs 26 and 28 hold prism 30 therebetween, and are received within hollow cap 14. Leafs 26 and 28 as well as hollow cap 14 are in an interference fit in relationship with one another. If desired, cap 14 can be adhesively secured to leafs 26 and 28 or welded thereto. There are four struts connecting the cylindrical body portion 22 and the collar 12. Three of these struts are shown in FIG. 2. Struts 34, 36 and 38 form a bridge between the body portion 22 and the collar 24 of frame 12. The fourth strut is not visible. In addition, these struts form four apertures, of which two are shown in FIG. 2. Apertures 50 and 52 allow the liquid medium (i.e., water or saline) to flow between the cylindrical body portion 22 and into the space defined by the two leaflets. Aperture 54 is formed between leaf 26 and 28 and collar 24. The liquid medium flows out of the two sides of the aperture 54 and across the input and reflective surfaces of the prism 30. Fiber optic 20 extends into the cylindrical body portion 22 and is mounted thereto as will be described in greater detail hereinbelow. As best seen in FIGS. 4, 5 and 6, the distal end of fiber optic 20 extends into the space defined, in part, by hollow cap 14 and is spaced from prism 30. The spacing between distal end face 42 of fiber optic 20 and input or incident face 44 of prism 30 is determined by shoulders 46 and 48 at the base of leafs 26 and 28, respectively. The spacing between the prism 30 and the distal end face 42 of fiber optic 20 is determined in part by the desired width of the emitted laser beam. Usually the spacing is in the range of about 5 to about 20 mils (125 μm to 510 μm), preferably about 10 mils to about 15 mils (255 μm to 350 μm). FIG. 6 is the cross sectional view taken along plane 6--6 of FIG. 4. Apertures 50, 51, 52 and 53 are formed in between the strut pairs (34, 40) (38, 40) (34, 36) and (36, 38) respectively. The fiberoptic is centered within the aforementioned struts. Apertures 50, 52 and 54 in frame 12 define liquid pathways for the liquid medium within cylindrical body portion 22. Prism 30 can be synthetic sapphire (refractive index 1.745), (SFL-57; refractive index about 1.811), amorphous glass containing Ge, As and Se (AMTIR-1; refractive index 2.51), and the like. The external dimensions of the catheter distal end, i.e., the cylindrical housing, can vary depending upon the desired end use of the catheter. For use in body lumens, the outside diameter of the cylindrical housing usually is in the range of about 0.5 to about 4 millimeters, preferably about 1 to about 2.5 millimeters. Prism 30 can have a flat or curved input face, output face and reflecting surface. If the aforementioned surfaces are flat, the ultimate divergence of the emitted beam from the prism will be determined by the divergence out of the fiberoptic and the angle of emission out of the output face. Consequently the spot size of the beam at a given distance from the emitting surface of the prism will also be determined largely by the divergence of the beam out of the fiber. In one embodiment of the invention, as shown in FIG. 7(a), the totally internal reflecting (TIR) surface 55 of the prism 57 can be rounded to form a convex physical surface. This convex physical surface will act as a concave TIR surface which will increase the effective divergence of the laser beam. The plane of the arc defined by such curvature will need to be parallel to the emitting face of the prism in order to laterally reflect substantially all of the incoming light beam. Alternatively, as shown in FIG. 7(b), the emitting surface 56 of the prism 58 can be rounded to form a convex physical surface to achieve the same diverging effect. The aforesaid increased divergence of the beam will increase the spot size formed at a fixed distance from the tip of the catheter and reduce the energy density thereof, compared to the embodiment incorporating a prism with either a flat reflective surface or a flat emissive surface. The increased divergence may have beneficial effects by creating a substantially coagulative effect, instead of an ablative effect, due to the lower energy density. FIG. 8 shows the propagation of light rays into and out of the high index prism. The angle at which these light rays travel within the prism is shown as α and can be calculated by (1) ##EQU1## where n 1 is the index of refraction of the surrounding medium, n 2 is the index of refraction of the prism and θ is the angle between the most divergent ray exiting the fiber and the normal to the input surface of the prism. The prism is cut at angle β with respect to the output face of the prism. Angle β can be found by β=90-θc-α (2) where θc is the critical angle of the prism liquid interface and can be calculated by (3) ##EQU2## For example, for the case of SFL57 (n 2 =1.811 at 1060 nm) in a water environment (n=1.33) and with a fiber of numerical aperture (NA)=0.22 (θ=9.55 degrees) β is found to be 35.75 degrees, while α is equal to 6.99 degrees. Fixing β at 35.75 degrees and substituting -6.99 degrees and +6.99 degrees for α, Γ 1 and Γ 2 are found to be 74.2 and 54.0 degrees respectively. Equation (4) is used to calculate the emission angles. ##EQU3## FIG. 9 shows another embodiment of the current invention, in which a convex surface has been formed on the input end of the prism 30. The convex surface acts as a lens and serves to collimate the light energy emitted from the fiberoptic distal end 42. Consequently the angle at which such rays travel through the material would be reduced and that would allow the angle Γ to be closer to the critical angle θc. This would result in the final angles of emission to be closer to 90 degrees. If desired, as shown in FIG. 10, a recess can be provided in the incident face of the prism, and the distal end of the fiber optic may be positioned therewithin, so as to reduce scattering and attendant energy losses. Another embodiment of the present invention is shown in FIG. 11, where catheter device 60 comprises prism 62 and fiber optic 64 mounted to housing 66, which can consist of two halves welded or glued together. Fiber optic 64 is spaced from prism 62. Housing 66 is hollow, defines a confined flow passageway for an ambient liquid medium, e.g., water or saline, and is provided with apertures 68 and 70 that permit the liquid medium to pass therethrough. The proximal end of fiber optic 64 is adapted for coupling to a laser source. Liquid medium within housing 66 provides optical coupling of fiber optic 64 to prism 62 which has a refractive index that is sufficiently higher than the refractive index of the surrounding liquid medium to permit total internal reflection of the light energy to occur. Housing 66 is secured to fiber optic 64 by crimping sleeve 72 unitary with housing 66 or, optionally, by an adhesive such as epoxy resin or the like, or both. Prism 62 is rod-shaped and is made of a transparent material such as synthetic sapphire, which has (a) an index of refraction sufficiently high to cause laser energy transmitted thereinto to be emitted substantially laterally from the longitudinal axis thereof when surrounded by a given liquid medium and (b) a melting point sufficiently high to preclude melting or other damage thereto when in direct contact with tissue during lasing. This embodiment can be used (a) in a non-contact mode, directing laser energy laterally in a fluid medium from prism 62 into the target tissue to coagulate the same to a chosen depth, which tissue will slough-off or be absorbed by the body over a period of several weeks, as well as, after coagulation of the tissue in the manner described in (a) above, (b) in a contact mode to vaporize or ablate tissue by placing the distal tip of prism 62 directly in contact with the tissue, thereby immediately removing a portion of the coagulated tissue constricting or obstructing a body lumen or cavity. The distal tip of the prism 62 can be rounded to minimize the risk of breakage and damage to body tissues. In the case of benign enlargement of the prostate, deep coagulation of the prostate gland using the present device in a non-contact mode will, over a period of weeks, restore urine flow, as the coagulated tissue is sloughed-off. However, even though a small amount of tissue may be vaporized during the lasing, due to edema (swelling) of tissue as a result of the coagulation procedure, a drainage tube must be inserted and worn with a urine collection bag by the patient for a period of several days, as the patient would otherwise be unable to urinate. Following the coagulation procedure described above, the device described in this embodiment can be used in contact mode to remove a desired amount of coagulated tissue without bleeding, to offset the edema, and to enable the patient to either (a) immediately urinate without the need for a drainage tube or (b) wear a drainage tube for a substantially shorter period of time before being able to urinate normally. Prism 62 can be made from a square or rectangular cross section rod, as well as from a cylindrical or oval rod, whose distal end has been beveled at an aforementioned angle β. To insure that prism 62 is not dislodged from housing 66 depressions 67 can be cut in the outer surfaces of prism 62, and ridges 69 of housing 66 matchingly engage therewith. Side elevation contour of prism 62 is shown in FIG. 15. As seen in FIG. 12, flexible catheter 76 is adhesively attached to frame 78. Fiber optic 74 is secured to sleeve 79 that extends rearwardly from frame 78. Fluid flow through apertures 71, 74 in frame 78 is indicated by connected arrows. FIG. 13 shows the cross sectional view along plane 13--13 of FIG. 12. A square cross section prism 62 housed within the tubular housing 66 defines passageways 73 through which the liquid medium can flow. The distal end of the prism can have various shapes. For example, as seen in FIG. 16, by utilizing a ball-tipped optical fiber 82 which has been beveled to the desired angle for total internal reflection, resulting prism 84 is less traumatic to tissue and the risk of breakage can be reduced. Referring to FIG. 14, the distal tip of prism 62 (FIG. 11) can be frosted by means known in the art or coated with a layer of light absorbing material 80, such as charcoal or a ceramic, to convert the light energy to heat for ablation or coagulation of tissue in contact therewith. The foregoing description and the drawings are intended as illustrative and are not to be taken as limiting. Still other variations and rearrangements of parts are possible and will readily present themselves to those skilled in the art.

A laser energy delivery catheter emits energy laterally relative to the longitudinal axis of the catheter. The catheter distal end is a cylindrical housing provided with a sidewall aperture. Within the housing is mounted a prism spaced from the distal end of a fiber optic. The refractive index of the prism is higher than the refractive indices of the fiber optic and the coupling liquid medium. A liquid medium is utilized to cool the device when in use, and may also be utilized to optically couple the fiber optic and the prism. The catheter can be configured as a rigid or semi-rigid, hand held surgical instrument, or as a flexible device that can be inserted into body lumens through an endoscope.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Priority is claimed from provisional patent application U.S. Ser. No. 61/957,196, filed on Jun. 26, 2013, and incorporated by referenced herein. FIELD OF THE INVENTION [0002] The present invention relates generally to surgical devices, system and method for internal fixation of fractures and non-unions of bones such as the femur. More particularly, the present invention provides a bone plating system for distal femur fractures and non-unions generally utilizing a specifically contoured bone plate or plates that fit to a corresponding specific portion or portions of the lower extremity of the femur. DESCRIPTION OF THE KNOWN PRIOR ART [0003] As known, the femur is the only bone in the thigh of humans and is the longest, heaviest and by most measures the strongest bone in the human body. The femur or thighbone is the most proximal bone of the leg in tetrapod vertebrates capable of walking or jumping and is categorized as a long bone and comprises a diaphysis, the shaft or body and two epiphyses that articulate with adjacent bones in the hip and knee. The femur is typically discussed as three general portions: the upper or proximal region, the middle portion referred to as the body or shaft, and the lower region often referred to as the distal femur, including the distal metaphysis and two condyles. [0004] The lower extremity of the femur or distal extremity is larger than the upper extremity. It is somewhat cuboid in form, but its transverse diameter is greater than its antero-posterior. It consists of two oblong eminences known as the condyles. [0005] Anteriorly, the condyles are slightly prominent and are separated by a smooth shallow articular depression called the patellar trochlea. Posteriorly, they project considerably and a deep notch, the intercondylar fossa of femur, is present between them. The lateral condyle is the more prominent and is the broader both in its antero-posterior and transverse diameters. The medial condyle is the longer and, when the femur is held with its body perpendicular, projects to a lower level. When, however, the femur is in its natural oblique position the lower surfaces of the two condyles lie practically in the same horizontal plane. The condyles are not quite parallel with one another; the long axis of the lateral is almost directly antero-posterior, but that of the medial runs backward and medialward. Their opposed surfaces are small, rough, and concave, and form the walls of the intercondyloid fossa. This fossa is limited above by a ridge, the intercondyloid line, and below by the central part of the posterior margin of the patellar surface. The posterior cruciate ligament of the knee joint is attached to the lower and front part of the medial wall of the fossa and the anterior cruciate ligament to an impression on the upper and back part of its lateral wall. [0006] The articular surface of the lower end of the femur occupies the anterior, inferior, and posterior surfaces of the condyles. Its front part is named the patellar trochlea and articulates with the patella. It presents a median groove, which extends downward to the intercondyloid fossa and two convexities, the lateral of which is broader, more prominent, and extends farther upward than the medial. [0007] Each condyle is surmounted by an elevation, the epicondyle. The medial epicondyle is a large convex eminence to which the tibial collateral ligament of the knee joint is attached. At its upper part is the adductor tubercle and behind it is a rough impression, which gives origin to the medial head of the gastrocnemius. The lateral epicondyle, which is smaller and less prominent than the medial, gives attachment to the fibular collateral ligament of the knee-joint. [0008] The knee is the largest weight-bearing joint in the body. The distal femur makes up the top part of the knee joint. The upper part of the shinbone or tibia supports the bottom part of the knee joint. The ends of the femur are covered in a smooth, slippery substance called articular cartilage. This cartilage protects and cushions the bone when bending and straightening the knee. [0009] The body of the femur or shaft is long, slender and almost cylindrical in form and connects to the distal portion. It is a little broader above than in the center, broadest and somewhat flattened from before backward below. It is slightly arched, so as to be convex in front, and concave behind, where it is strengthened by a prominent longitudinal ridge, the linea aspera that diverges proximal and distal as the medial and lateral ridge. [0010] Fractures of the thighbone that occur just above the knee joint are called distal femur fractures. The distal femur is where the bone flares out like an upside-down funnel. Fractures of the distal femur most commonly occur in two patient types that being younger people typically considered under age 50 and the elderly. [0011] Distal femur fractures in younger patients are usually caused by high-energy injuries, such as falls from significant heights or motor vehicle collisions. Because of the forceful nature of these fractures, many patients also have other injuries, often of the head, chest, abdomen, pelvis, spine, and other limbs. [0012] Elderly people with distal femur fractures typically have poor bone quality. As we age, our bones get thinner. Bones can become very weak and fragile. A lower-force event, such as a fall from standing, can cause a distal femur fracture in an older person who has weak bones. Although these patients do not often have other injuries, they may have concerning medical problems, such as conditions of the heart, lungs, and kidneys, and diabetes. [0013] Distal femur fractures vary. The bone can break straight across often referred to as a transverse fracture or into many pieces often referred to as a comminuted fracture. Sometimes these fractures extend into the knee joint and separate the surface of the bone into a few or many parts. These types of fractures are called intra-articular. Because they damage the cartilage surface of the bone, intra-articular fractures can be more difficult to treat. [0014] Distal femur fractures can be closed, meaning the skin is intact, or can be open. An open fracture is when a bone breaks in such a way that bone fragments stick out through the skin or a wound penetrates down to the broken bone. Open fractures often involve much more damage to the surrounding muscles, tendons, and ligaments. They have a higher risk for complications and take a longer time to heal. [0015] When the distal femur breaks, both the hamstrings and quadriceps muscles tend to contract and shorten. When this happens, the bone fragments change position and become difficult to line up with a cast. [0016] It is known in distal humerus fractures to utilize medial and lateral column plating. It is also known in proximal tibia fractures to utilize medial and lateral column plating. However, distal femur fractures are typically treated with just lateral plates. Lateral locking plates are well established and generally have a good track record, but lateral plate failure is also well known. [0017] When lateral locking plates fail, it is common to go varus or apex lateral angulation of the distal segment of a bone. Furthermore, lateral plates have no medial column support or buttress. When varus failure occurs, medial buttress plating is often done and the current prior art option is to bend a straight plate and hope it fits well. [0018] Although numerous advancements have occurred in the field of bone plates in general, the prior art still has failed to bridge the gap between the needs of medical professionals treating distal femur issues and the ever increasing demand. Therefore, an extensive opportunity for design advancements and innovation remains for medial distal femur plate devices, systems, and methods where the prior art fails or is deficient. SUMMARY OF THE INVENTION [0019] In general, the present invention is a new and improved surgical device, system, and method which provides a bone plate for the treatment of fractures and non-unions of femurs where the prior art fails. The present invention generally provides a contoured plate or plates specifically contoured to correspond with associated locations on the medial distal femur. [0020] Without the intention of limitation, the invention may generally comprise a plate or plates adapted to conform to the medial area of the distal femur from generally near the medial epicondyle and generally up the shaft of the femur. The plate may include numerous apertures for fixation to the distal femur as desired such as but not limited to an offset screw design along the shaft to allow location of screws around a nail or other feature. A preferred construction may allow for the placement of screws through the plate into the shaft of the femur, the placement of screws through the plate generally into the lateral condyle, the placement of screws through the plate generally into the medial condyle and so forth. It is understood that the current invention may allow for fixation for multiple sites. The medial distal plate may be used in conjunction with a lateral distal plate. It is further contemplated to provide an extension plate to generally cover the medial condyle. [0021] Furthermore, the invention may include a method for utilizing a medial distal plate such as but not limited to making an incision approximately 15 cm from the knee joint proximally. Deep fascia may be split in line with the skin incision and may include saphenous vein and nerve retracted either anteriorly or posteriorly. Vastus medialis may be dissected off of the intermuscular or IM septum. Subperiosteal dissection may expose distal femur and to be noted is that the femoral vessels may be safely out of the fixation zone. [0022] 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 this application to the details of construction and to the arrangement 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. [0023] Accordingly, titles, headings, chapter names, classifications and overall segmentation of the application in general should not be construed as limiting. Such are provided for overall readability and not necessarily as literally defining text or material associated therewith. [0024] Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientist, 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. [0025] It is therefore an object of the present invention to provide a new and improved medial distal femur bone plate devices, system and method of using the same that provides greater ease of use, patient comfort, and function to a wide range of uses associated with the fractures and non-unions. [0026] It is a further object of the present invention to provide a new and improved medial distal femur bone plate devices, system and method of using the same, which is of a robust design, as well as be easily and efficiently manufactured. [0027] An even further object of the present invention is to provide a new and improved medial distal femur bone plate devices, system and method of using the same, which is of a more durable and reliable construction than that of the existing known art. [0028] Still another object to the present invention is to provide a new and improved medial distal femur bone plate devices, system and method of using the same, which is susceptible of a low cost of manufacture with regard to both materials and labor, which accordingly is then susceptible of competitive prices of sale to the public, thereby making such economically available to those in need. [0029] Another object of the present invention is to provide a new and improved medial distal femur bone plate devices, system and method of using the same, which provides some of the advantages of the prior art, while simultaneously overcoming some of the disadvantages normally associated therewith. [0030] Yet another object of the present invention is to provide a new and improved medial distal femur bone plate devices, system and method of using the same that provides multiple fixation options as well as multiple treatment location options. [0031] Still further, it is an object of the present invention to provide a new and improved medial distal femur bone plate devices, system and method of using the same that will allow the medical professional to always have a readily available bone plate system that allows a surgeon to plate around previously inserted objects such as but not limited to intramedullary nail, total knee arthroplasty and so forth. [0032] It is a further object of the present invention to provide a new and improved medial distal femur bone plate devices, system and method of using the same that may be used in conjunction with a lateral distal femur plate and other medial lateral plates. [0033] 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 would be had to the accompanying drawings and descriptive matter in which there are illustrated preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS AND PICTORIAL ILLUSTRATIONS [0034] 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 pictorial illustrations, graphs, drawings, and appendices. [0035] FIG. 1 is a general top view depiction of a preferred embodiment of the invention attached to a femur. [0036] FIG. 2 is a general side view depiction of a preferred embodiment of the invention attached to a femur. [0037] FIG. 3 is a general side view depiction of a preferred embodiment of the invention attached to a femur and also generally depicting a distal lateral plate. [0038] FIG. 4 is a general depiction of a method for making and locating an incision in accordance with a preferred embodiment of the invention [0039] FIG. 5 is a general side view depiction of a preferred embodiment of the invention. [0040] FIG. 6 is a general top view depiction of a preferred embodiment of the invention. [0041] FIG. 7 is another general top view depiction of a preferred embodiment of the invention. [0042] FIG. 8 is another general side view depiction of a preferred embodiment of the invention attached to a femur. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0043] Referring now to the drawings, wherein like reference numerals designate corresponding structure throughout the views, and referring in particular to FIG. 1 , reference numeral 10 generally refers to a new and improved medial distal femur bone plate devices, system and method of using the same hereinafter referred to as “invention 10 ” or “invention”, in accordance with a preferred embodiment of the current invention. [0044] Invention 10 generally contemplates, as discussed further below, a pre-contoured plate designed for fixation of the femur shaft and distal femur that is applied to the medial side of the femur. The plate may include holes that may have threads and a shape to accommodate locking screws, non-locking screws, cables, pins, trochars, guides, buttons, and or extensions that may be located along the entire length of the plate. Invention 10 contemplates additional holes of varying sizes and shapes along the plate for accommodating other bone fixation devices such as wires, pins, buttons, cables, extensions, guides, and so forth. The distal portion of the plate may match the shape of the medial portion of the medial condyle. The screw holes along the distal portion of the plate may be designed to accommodate screws for fixation of the distal femur, including the medial condyle, lateral condyle, intercondylar trochlea, and metaphyseal portion of the femur. The shaft portion of the plate may be essentially straight in the coronal plane with a slight curve in the sagittal plane to match the natural sagittal curve of the femur shaft. [0045] The screw holes along the shaft portion of the plate may accommodate screws for affixing the plate to the medial femur shaft and/or for fixation of fractures extending proximal to the distal femur along the shaft of the femur. There may be a transitional portion of the plate that will curve between the shaft portion and the distal portion. The curve of this transitional zone may contour to the distal medial metaphyseal portion of the femur. There may be screw holes or other holes placed along this transitional zone of the plate [0046] More in particular, invention 10 may generally include plate 20 having a first end 30 , a shaft and or middle 40 , a second end 50 , a top surface 60 , a bottom surface 70 , a width 80 , a length 90 , and a thickness 100 . It is understood that plate 20 may have many configurations, shapes, sizes and so forth and the current invention should not be considered limited to the illustrations. It is also contemplated that first end 30 may include a flared portion 35 generally making first end 30 wider than second end 50 and middle 40 . The illustrations generally depict a preferred embodiment and it is understood that numerous other embodiments are contemplated. [0047] Referring to the illustration and more in particular to FIG. 6 , in a preferred embodiment length 90 may be about 15 centimeters. It is understood that length 90 may be shorter or longer. In a preferred embodiment, width 80 may be about 18 mm around second end 50 and or middle 40 and 35 mm around first end 30 and flare 35 . It is also understood that width 80 may be shorter or longer. In a preferred embodiment, thickness 100 may be about 5 mm. It is understood that thickness 100 may be greater or lesser. It is also understood that plate 20 may be generally sized to generally adapt for larger people, smaller people, and so forth and contoured accordingly. Invention 10 may include a surgery kit with numerous sizes of bone plate 20 as desired for treating individuals. [0048] Invention 10 may include numerous holes or aperture 110 as will be discussed further below. It is also understood that invention 10 may utilize bone anchors 120 such as but not limited to known cannulated locking screws as indicated for certain types of fractures and non-unions of the proximal femur. Invention 10 may also utilize other bone anchors 120 such as non-cannulated non-locking screws, non-cannulated locking screws, variable angle locking screws, fixed angle nails, pins, blades, cables, wires and combination thereof. It is also understood that bone anchors 120 generally cooperate with plate 20 apertures 110 to secure the various bone anchor 120 to the femur 130 as will also be discussed in greater detail below. [0049] Again referring to the illustration and more in particular to FIG. 7 , invention 10 contemplates utilizing scalloped edges 105 . It is contemplated that plate 20 may have a configuration wherein irregular edges may be included such that a flare is created out around the holes 110 . It is understood that numerous configurations of scalloped edges 105 are contemplated and the illustration should not be considered to limit invention 10 to the depicted. [0050] Bone plate 20 may be made from metal such as but not limited to stainless steel, titanium, composite materials, combinations thereof, and so forth. It is understood that plate 20 may be made of other materials other than metal. Bone anchors 120 are known in the art and may be of numerous materials. [0051] Referring to the illustration in general and more in particular to FIG. 2 , It is understood that femur 130 has a distal end 140 , a medial epicondyle 150 , a medial condyle 155 , a lateral epicondyle 160 , a lateral condyle 165 , a medial aspect or side 170 , a lateral aspect or side 180 , an anterior aspect or side 190 , a posterior aspect or side 200 , adductor magnus tubercle 205 , a patellar surface 210 , intercondylar trochlear region 215 , main body or shaft 220 , metaphyseal bone portion 225 and so forth. [0052] It is understood that the articular surface 227 of the lower or distal end 140 femur 130 occupies the anterior, inferior, and posterior surfaces of the condyles. Its front part is named the patellar surface 210 and articulates with the patella. [0053] Invention 10 contemplates plate 20 bottom surface 70 , thickness 100 , and or top surface 60 are generally contoured to adapt to femur 130 distal end 140 medial aspect 170 . Bottom surface 70 may be generally curved as depicted although invention 10 contemplates numerous contouring and or curvature. [0054] Invention 10 contemplates plate 20 generally to be positioned such that first end 30 does not extend past medial condyle 155 , but rather ends on or about medial epicondyle 150 , articular surface 227 of medial condyle 155 and or adductor magnus tubercle 205 as generally depicted. It is also contemplated that plate 20 may extend past the aforementioned. Second end 50 may generally be positioned on shaft 220 of femur 130 and may have a varying length 90 . Plate 20 second end 50 may generally be positioned along femur 130 shaft 220 and be limited in length 90 and generally positioning by the vascular structures crossing the medial aspect 170 femur 130 from anterior aspect 190 to posterior aspect 200 such as femoral artery and or femoral vein. It is also contemplated that length 90 of bone plate 20 generally may be the same as the length between shaft 220 and same medial epicondyle 150 of femur 130 in a preferred construction. [0055] Plate 20 may extend posteriorly to the level of the adductor magnus tubercle 205 and posterior aspect 200 to femur 130 shaft 220 . Plate 20 may also extend anteriorly to the anterior-medial portion of femur 130 shaft 220 and medial and anterior-medial facet of the medial condyle 155 and medial epicondyle 150 . [0056] The present invention 10 contemplates providing plate 20 with apertures 110 A, 110 B, 110 C, and 110 D for generally positioning bone anchors 120 A, 120 B, 120 C, and 120 D generally anterior aspect 190 and on shaft 220 . The present invention 10 also contemplates providing plate 20 with apertures 110 E, 110 F, 110 G, and 110 H for generally positioning bone anchors 120 E, 120 F, 120 G, and 120 H generally posterior aspect 200 on shaft 220 . It is further contemplated these bone anchors 120 are generally perpendicular to plate 20 . Although it is understood that closer to the medial epicondyle 150 the angle may change more so and the bone anchors 120 may engage the region below the area known commonly as the shaft 220 such as but not limited to medial condyle 155 , lateral condyle 165 , and so forth. [0057] Holes or apertures 110 may be threaded, angled, and so forth to cooperate with bone anchors 120 . A preferred embodiment may be where bone anchors 120 head finish generally flush with bone plate 20 top surface 60 . By example, holes or apertures 110 may further include a recessed portion for providing a screw head to finish flush generally inside bone plate 20 . [0058] Referring to the illustration and more in particular to FIGS. 2 and 5 , it is understood that plate 20 has generally an angle or curve 230 wherein plate 20 first end 30 is generally flush along femur 130 corresponding angle or curve 240 and generally positioned above the medial epicondyle 150 . Curve 230 may be generally angled as defined as angle 260 between Line AA which may generally lay along and parallel with plate 20 bottom surface 70 at second end 50 and Line BB, which may generally lay along and parallel with first end 30 . Angle 260 may generally be 20 degrees although it is contemplated that angle 260 may be greater or smaller. [0059] Still further, invention 10 contemplates utilizing plate 20 with apertures 110 I, 110 J, 110 K, 110 L, 110 M, and 110 N for generally positioning bone anchors 120 I, 120 J, 120 K, 120 L, 120 M, and 120 N along plate 20 curve 230 . These bone anchors 120 may generally be longer such that they engage the medial condyle 155 and lateral condyle 165 . [0060] It is contemplated that bone anchors 120 may generally be placed along plate 20 first end 30 , shaft and or middle 40 , second end 50 . It is further contemplated that bone anchors 120 such as but not limited to screws generally positioned on first end 30 plate 20 angle or curve 230 may be pointed in such a trajectory as to gain fixation in the medial condyle 155 , lateral condyle 165 , intercondylar trochlear region 215 , and/or the metaphyseal bone 225 of the distal end 140 femur 130 . [0061] Bone anchors 120 may be directed around previously-placed hardware such as the femoral component of total knee arthroplasty, intramedullary implants, plates, screws, or other implanted hardware. In a preferred embodiment, bone anchors 120 may be positioned with plate 20 such that bone anchors 120 do not touch. [0062] Referring to the illustrations again and more in particular to FIG. 3 , in a preferred embodiment, invention 10 may include use of a lateral plate 250 . It is understood that lateral plate 250 may be of a similar construction as plate 20 but corresponding to the lateral distal femur accordingly. [0063] Once again referring to the illustrations and more in particular to FIG. 8 , in a preferred construction, invention 10 may utilize an extension plate 270 that generally covers medial condyle 155 and may or may not abut plate 20 first end 30 . It is contemplated that extension plate 270 may include apertures 110 for bone anchors 120 . [0064] Once again referring to the drawings in general and more specifically to FIG. 4 , invention 10 may include a method for utilizing a medial distal plate 20 such as but not limited to making an incision approximately 15 cm from the knee joint proximally. Deep fascia may be split in line with the skin incision and may include saphenous vein and nerve retracted posteriorly. Vastus medialis may be dissected off of the intermuscular or IM septum. Subperiosteal dissection may expose distal femur 130 and to be noted is that the femoral vessels may be safely out of the fixation zone. [0065] Invention 10 may be utilized for the direct fixation of the medial aspect 170 distal end 140 of femur 130 and medial aspect 170 femur 130 shaft 220 , primary fixation of distal end 140 femur 130 fractures, primary fixation of femur 130 shaft 220 fractures, secondary (adjunct) fixation of distal end 140 femur 130 or femur 130 shaft 220 fractures in addition to intramedullary or lateral-based fixation, and so forth. Invention 10 may also be utilized with periprosthetic fractures including but not limited to above the femoral component of total knee arthroplasty, at the distal end of intramedullary implant in femur 130 , above or below previously-placed femoral hardware, and so forth. It is also contemplated to be utilized with an out rigger as known in art for percutaneous fixation. [0066] Possible indications may be primary fractures of femur 130 shaft 220 or distal end 140 femur 130 , peri-prosthetic fractures of femur 130 shaft 220 or distal end 140 femur 130 , non-united fractures of femur 130 shaft 220 and or distal end 140 femur 130 requiring primary or secondary medial aspect 170 fixation, and so forth. [0067] It is therefore contemplated invention 10 may provide bone plate 20 for treating fractures and non-unions of distal femur 130 said femur 130 having shaft 220 with medial aspect 170 , medial epicondyle 150 , and a length defined as the distance between said shaft 220 with medial aspect 170 and said medial epicondyle 150 and wherein said length has curve 240 ; said bone plate 20 comprising top surface 60 , bottom surface 70 for contacting said femur 130 ; one or more apertures 110 wherein said one or more apertures 110 pass through said top surface 60 and said bottom surface 70 and are configured to fix a bone anchor 120 through said top surface 60 and said bottom surface 70 to attach said bone plate 20 to said femur 130 ; first end 30 for attaching to said medial epicondyle 150 ; second end 50 for attaching to said shaft 220 with medial aspect 170 ; length 90 defined as the distance between said first end 30 and said second end 60 and said length 90 having curve 230 wherein said length 90 generally matches said length on said femur 130 and wherein said curve 230 generally matches said curve 240 of said length on said femur 130 . [0068] Accordingly, other implementations are within the scope of the following claims. Changes may be made in the combinations, operations, and arrangements of the various parts and elements described herein without departing from the spirit and scope of the invention.

The current invention comprises a bone plate and method of use contoured to fit above the medial epicondyle that provides numerous apertures for fixation to the distal femur as desired with an offset screw design in shaft to allow location of screws around a nail or other feature and may also allow for attachment in conjunction with a lateral distal plate and or an extension plate that may cover the medial condyle.

BACKGROUND A play yard forms an enclosed space in which young children and/or animals can be placed for security and safety. A typical play yard is made up of several panels and is self-supporting. To enter and exit the play yard, it can be necessary to step over the play yard panels or unhook two of the panels to form a space. Both such actions can be difficult, particularly when carrying a larger child or animal into or out of the play yard. SUMMARY In one aspect, a play yard includes: a plurality of side panels coupled to one another; a gate panel coupled to two of the plurality of side panels to create an enclosed space, the gate panel including: a panel frame defining an opening; a gate mounted to the panel frame in the opening to swing from a closed position to an open position; a first locking mechanism on the gate to hold the gate in the closed position; and a second locking mechanism on the gate frame to hold the gate in the closed position. In another aspect, a play yard includes: a plurality of side panels coupled to one another; a gate panel coupled to two of the plurality of side panels to create an enclosed space, the gate panel including: a panel frame including a panel base member and side members that define an opening; a gate mounted to the panel frame in the opening to swing from a closed position to an open position; a first locking mechanism on the gate to hold the gate in the closed position, the first locking mechanism including a hook member sized to engage an opening defined by the panel frame; and a second locking mechanism on the gate to hold the gate in the closed position, the second locking mechanism including a switch configured to move between locked and unlocked positions; wherein the gate is configured to be opened by allowing the second locking mechanism to be moved to the unlocked position, and the gate being thereupon moveable upwardly away from the panel base member to allow the hook member to disengage the opening of the panel frame. In yet another aspect, a method for using a play yard includes: assembling a plurality of side panels and a gate panel including a gate to form an enclosed space; moving a first locking mechanism from a locked position to an unlocked position; lifting the gate in the gate panel to clear a second locking mechanism; and swinging the gate from a closed position to an open position. DESCRIPTION OF THE DRAWINGS FIG. 1 is a front perspective view of an example play yard. FIG. 2 is a back perspective view of the play yard of FIG. 1 . FIG. 3 is a front perspective view of an example gate panel of the play yard of FIG. 1 with the gate in the closed position. FIG. 4 is a back perspective view of the gate panel of FIG. 3 . FIG. 5 is a front view of the gate panel of FIG. 3 . FIG. 6 is a bottom view of the gate panel of FIG. 3 . FIG. 7 is a side view of the gate panel of FIG. 3 . FIG. 8 is a back view of the gate panel of FIG. 3 . FIG. 9 is a front perspective view of an example gate of the gate panel of FIG. 3 . FIG. 10 is a back perspective view of the gate of FIG. 9 . FIG. 11 is a front view of the gate of FIG. 9 . FIG. 12 is a back view of the gate of FIG. 9 . FIG. 13 is a first side view of the gate of FIG. 9 . FIG. 14 is a top view of the gate of FIG. 9 . FIG. 15 is a bottom view of the gate of FIG. 9 . FIG. 16 is a second side view of the gate of FIG. 9 . FIG. 17 is a front perspective view of the gate panel of FIG. 3 with the gate in the open position. FIG. 18 is a front view of the gate panel of FIG. 3 with the gate removed. FIG. 19 is a back view of the gate panel of FIG. 18 . FIG. 20 is a front view of the gate panel of FIG. 3 with a locking mechanism in a closed position. FIG. 21 is a cross-sectional view taken along line 21 - 21 of the gate panel of FIG. 20 . FIG. 22 is another front view of the gate panel of FIG. 3 with the locking mechanism in the open position. FIG. 23 is a cross-sectional view taken along line 23 - 23 of the gate panel of FIG. 22 . FIG. 24 is a front view of the gate panel of FIG. 3 with a portion of the gate removed to show the locking mechanism. FIG. 25 is an enlarged portion of the gate panel shown in FIG. 8 . DETAILED DESCRIPTION The present disclosure is directed towards a gate for a play yard. Examples are provided herein. However, the disclosure is not limited to the examples. Referring now to FIGS. 1-2 , an example play yard 100 is shown. In this example, the play yard 100 includes a plurality of panels. All but one of the panels in this example are identical and are referred to herein as side panels 110 . There are five side panels 110 in the play yard 100 . The side panels 110 are connected by hinges 116 and rods 118 to form five of the six sides of the play yard 100 . The other panel is similar to the side panels 110 , except the panel includes a gate 114 and is referred to herein as a gate panel 112 . The gate panel 112 connects to the other side panels 110 in a similar fashion. The gate 114 of the gate panel 112 pivots between a closed position (as shown in FIGS. 1-2 ) and an open position (as shown in FIG. 17 ). The panels 110 , 112 together form an enclosed space into which a child and/or animal can be placed for security and safety. In this example, the enclosed space is generally hexagonal in shape. In other examples, other numbers of panels and sizes/shapes of the enclosed space can be used. The gate panel 112 can be used to access the enclosed space by opening the gate 114 to gain access into and out of the enclosed space formed by the panels 110 , 112 . In examples, the play yard 100 is made of a plastic material, although other materials, such as wood or metal, can also be used. Referring now to FIGS. 3-8 , the gate panel 112 includes a base member 124 and side members 122 , 126 that form an opening for the gate 114 . The gate 114 is mounted to pivot members 130 , 132 on the side member 122 so that the gate 114 can pivot between the closed and open positions. Referring now to FIGS. 9-16 , the gate 114 includes pivot members 142 , 144 that engage the pivot members 130 , 132 on the gate panel 112 to pivotally connect the gate 114 to the gate panel 112 . The gate 114 also includes a base member 152 defining a space 153 that engages the base member 124 when in the closed position, as described further below. The gate 114 includes a first locking mechanism 154 including a hook member 155 sized to engage a window opening 410 on the gate panel 112 when in the closed position. The gate 114 includes a second locking mechanism 156 that moves between locked and unlocked positions to lock and unlock the gate 114 from the gate panel 112 . Finally, a switch 158 moves between locked and unlocked positions to lock the second locking mechanism 156 so that the second locking mechanism 156 cannot be actuated when the switch 158 is in the locked position. Additional details on the first and second locking mechanisms 154 , 156 and the switch 158 are shown in FIGS. 17-25 , which are described further below. The gate 114 includes a lattice structure 160 with a plurality of openings that allow the user to see through the lattice structure 160 into and out of the play yard 100 . Referring now to FIGS. 17-25 , additional details on the first and second locking mechanisms 154 , 156 are provided. In FIG. 17 , the gate 114 of the gate panel 112 has been pivoted from the closed position (see, e.g., FIGS. 1-8 ) to the open position in a direction 302 . In order to move the gate 114 into this position, the switch 158 must be in the unlocked position, and the first and second locking mechanisms 154 , 156 must be actuated. The switch 158 is shown in more detail in FIG. 24 . In this example, the switch 158 moves in directions 452 , 454 . In the direction 452 , the switch 158 is unlocked. In the direction 454 , the switch 158 is locked, as shown in FIG. 24 . In the locked position, the switch 158 limits the travel of the second locking mechanism 156 in a direction 474 so that the second locking mechanism 156 remains locked with respect to the side member 126 of the gate panel 112 . Specifically, the second locking mechanism 156 includes a member 460 that extends from a handle portion 468 to a pin member 464 that engages a window 304 in the side member 126 (see FIGS. 17, 21, 23 ) to lock pivoting of the gate 114 relative to the gate panel 112 in the direction 302 . An end 462 of the member 460 is stopped from moving in the direction 474 by the switch 158 when in the locked position (i.e., in direction 454 ) so that the pin member 464 cannot clear the window 304 on the side member 126 , thereby retaining the gate 114 in the closed position. See FIGS. 20-21 . When the switch 158 is moved in the direction 452 , the end 462 can thereupon clear the switch 158 to allow the second locking mechanism 156 to be moved in the direction 474 until the pin member 464 is completely removed from the window 304 in the side member 126 , thereby unlocking the second locking mechanism 156 . See FIGS. 22-23 . The second locking mechanism 156 is biased in the direction 472 into the locked position so that force must be applied to the handle portion 468 to move the second locking mechanism 156 in the direction 474 to unlock the second locking mechanism 156 to allow the gate 114 to be moved to the open position. In addition, the hook member 155 of the first locking mechanism 154 engages the window opening 410 on the gate panel 112 to secure the gate 114 in the locked position. See FIG. 25 . In this position, an end 157 of the hook member 155 extends below the window opening 410 so that the gate 114 cannot be moved in the direction 302 to open the gate 114 . In addition, the hook member 155 , when positioned in the window opening 410 , minimizes any tendency of the side member 126 to move or bow in a direction 702 away from the gate 114 , which could result in the inadvertent disengagement of the pin member 464 of the second locking mechanism 156 from the window 304 in the side member 126 . In this manner, the hook member 155 functions to maintain the gate 114 in the closed position should external forces be applied to the side member 126 . To open the gate 114 , the gate 114 , including the hook member 155 , is lifted in a direction 602 until the end 157 of the hook member 155 clears the window opening 410 , thereby allowing the hook member 155 to fit through the window opening 410 and the gate 114 to pivot in the direction 302 . When the gate 114 is closed, the gate 114 is moved in a direction 604 by gravity to engage the hook member 155 with the window opening 410 . The amount of force necessary to move the gate 114 in the direction 602 can be modified so that small children and animals cannot provide the necessary force, while adults can easily move the gate 114 in the necessary direction to unlock the gate 114 . Finally, in the closed position, the base member 152 of the gate 114 engages an edge 125 of the base member 124 of the gate panel 112 to resist movement of the gate 114 in the direction 302 . Specifically, when closed, the space 153 formed by the base member 152 of the gate 114 engages the edge 125 of the base member 124 so that the bottom of the gate 114 resists movement in the direction 302 . This can be important, for example, if small children or animals exert a force at the bottom of the gate 114 . Only when the gate 114 is lifted in the direction 602 does a back edge 171 of the base member 152 (see FIGS. 13 and 16 ) clear the base member 124 so that the gate 114 can be pivoted in the direction 302 . In the closed position, gravity moves the gate 114 in the direction 604 so that the space 153 formed by the base member 152 of the gate 114 engages the base member 124 . Again, the force needed to lift the gate in the direction 602 can be manipulated so that small children and animals cannot provide the needed force. The steps necessary to open the gate 114 are as follows. Initially, switch 158 is moved in the direction 452 into the unlocked position, and the second locking mechanism 156 is moved in the direction 474 so that the pin member 464 clears the window 304 in the side member 126 . Next, the gate 114 is lifted in the direction 602 so that: (i) the hook member 155 clears the window opening 410 , thereby allowing the hook member 155 to fit through the window opening 410 ; and (ii) the back edge 171 of the base member 152 clears the base member 124 . In this configuration, the gate 114 can be pivoted in the direction 302 to the open position. To again lock the gate 114 , the second locking mechanism 156 is moved in the direction 474 , and the gate 114 is pivoted until the hook member 115 is positioned through the window opening 410 and the space 153 formed by the base member 152 is positioned above the base member 124 . In this configuration, the gate 114 is released, allowing the gate to move in the direction 604 so that the hook member 115 engages the window opening 410 and the base member 152 engages the base member 124 of the gate panel 112 . In addition, the second locking mechanism 156 is biased back in the direction 472 so that the pin member 464 engages the window 304 . Finally, the switch 158 can be moved in the direction 454 to resist inadvertent unlocking of the second locking mechanism 156 . Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.

A play yard can include a plurality of side panels that are connected to one another and a gate panel connected to two of the side panels to create an enclosed space. The gate panel can include a panel frame that defines an opening and a gate that can be mounted to the panel frame in the opening to swing from a closed position to an open position. The gate panel can include a first locking mechanism on the gate to hold the gate in the closed position and a second locking mechanism on the gate to hold the gate in the closed position.

BACKGROUND OF THE INVENTION The present invention relates to a mop holder in which a mop can be mounted and removed with extreme ease and which can hold the mop securely. Though numerous improvements in mop holders have been proposed in order to provide easy mounting of a mop, there still seems to be much to be improved especially in view of the fact that the prior art mop holders are rather complicated in mechanism and yet they fail to provide a tight and reliable grip of a mop. Further, most prior art mop holders necessarily have to use a shaft and springs as their parts. More specifically, problems with the prior art mop holders are that the production cost is rather high, that the holding power is unevenly distributed on the mop, thus frequently allowing part of the mop to slip off, and that some parts are liable to corrode rapidly, making the holder itself useless. SUMMARY OF THE INVENTION An object of the present invention is to provide a mop holder which obviates the abovesaid shortcomings, which can hold a mop easily and firmly, and which can be produced at a low cost. In accordance with the present invention, there is provided a mop holder comprising: a mop gripper being of a substantially inverted U-shaped section and having a main plate and a pair of side plates integral with the main plate, the side plates being formed on the inner surface thereof with stoppers adapted to engage a mop gripped between the side plates, the mop gripper being formed on its outer surface with a pair of longitudinal guide ridges; and a retainer being of a substantially inverted U-shaped section and having a handle holder and a pair of side plates formed at lower ends thereof with a pair of longitudinal flanges; and the mop gripper being received in the retainer with the guide ridges on the mop gripper rested on the longitudinal flanges on the retainer, thereby preventing the mop gripper from falling off the retainer. BRIEF DESCRIPTION OF THE DRAWINGS Other features and objects of the present invention will become apparent from the following description taken with reference to the accompanying drawings, in which: FIG. 1 is a partially cutaway perspective view of the embodiment of the mop holder according to the present invention; FIG. 2 is a front view of the retainer; FIG. 3 is a sectional view taken along line A--A of FIG. 2; FIG. 4 is a front view of the gripper; FIG. 5 is a sectional view of the same taken along line B--B of FIG. 4; FIG. 6 is a sectional view of the same with its grip plates spread open; FIG. 7 is a front view of the gripper with a mop mounted thereby; FIG. 8 is a front view of the holder showing how the gripper with the mop is inserted into the retainer; and FIG. 9 is a front view of the same with the mop fully mounted. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring more specifically to the drawings, a cleaning mop gripper 1 (FIGS. 4 to 6) has a main plate 2 integrally formed with a pair of downwardly extending spreadable grip plates 3 at both sides. The grip plates 3 are provided on their inner surfaces 4 over substantially the whole length thereof with mop stopper members 5 to hold the top end of a mop 8 between the grip plates 3 and on their outer surfaces with longitudinal guide ridges 6. A retainer 7 is formed with a groove having its bottom open to detachably receive the mop gripper 1 holding the top end of the mop 8 between the inner surfaces 4 of its grip plates 3. The side walls 9 of the retainer 7 defining the groove are each provided on their inner surface at the lower edge with inwardly extending longitudinal flanges 10 adapted to abut and support the lower edge of each guide ridge 6 on the gripper 1 when the mop gripper 1 is fully inserted into the retainer 7 to prevent the gripper from coming off the retainer. Both the retainer 7 and the gripper 1 may be integrally molded. In use, the grip plates 3 of the gripper 1 are spread open to some extent as shown in FIG. 6 to receive the top end of the mop 8 between their inner surfaces 4. Then, the mop stopper members 5 formed on the opposed inner surfaces of the grip plates 3 over the whole length bite into the mop 8, keeping the mop from slipping off the gripper 1. Also, since the gripper 1 is snugly received in the groove in the retainer 7 with the bottom edge of its guide ridges 6 rested on the top edge of the flanges 10 on the retainer 7 as shown in FIG. 8, not only is the gripper 1 kept from falling off the retainer 7 but also its grip plates 3 are prevented from spreading out by being elastically pushed by the mop 8. Thus, the mop 8 is firmly held by the gripper 1 received in the retainer 7 as shown in FIG. 9. The retainer 7 presses upon the grip plates 3 over substantially their whole length and the mop stoppers 5 adapted to bite into the mop 8 are provided on the inner surfaces of the grip plates 3 over substantially the whole length, so that the top portion of the mop 8 is held firmly with a uniform force over its entire length. To dismount the mop 8, the gripper 1 is pulled out of the retainer 7 and its grip plates 3 are spread open to draw the mop stoppers 5 out of the mop 8. The mop stoppers 5 may be in the form of serrations, projections, ridges or combinations thereof. The retainer 7 should preferably have its side plates 9 coupled together at one end thereof by means of a coupling member 11 and the gripper 1 should be provided with another coupling member 12 at one end thereof in such a manner that its both arm portions will get into engagement with the outer surface of the side plates 9 of the retainer 7 at the other end. Such coupling members will prevent the side plates 9 from yielding to the elastic force of the mop 8 or any other undue force which may be applied while using the mop, thus preventing the gripper 1 from falling off the retainer 7. In this embodiment, as shown in the drawings, the side plates 9 of the retainer 7 are formed each with a cutout 13 in the outer surface at the other end to receive the side arm portion of the coupling member 12. The retainer 7 should preferably be provided with projections 15 on the bottom surface of its top plate 14 so that they will engage projections 16 formed on the top surface of the main plate 2 of the gripper 1 when the gripper is fully inserted into the retainer 7 as shown by broken lines in FIG. 9. This arrangement, too, will prevent the gripper 1 from falling off the retainer 7. As shown in the drawings, a finger hold 17 provided at one end of the gripper 1 facilitates the mounting and removal of the gripper. A handle holder 18 may be fixed to the retainer 7 so as to extend upright as in the embodiment or to extend obliquely or may be pivotally mounted on the retainer as necessary. In order to mount a mop to the mop holder of the present invention, the grip plates of the gripper 1 are spread open, the mop 8 is inserted into between the inner surfaces 4 of the grip plates 3, and then the gripper 1 holding the mop is inserted into the groove formed in the retainer 7 so that the lower edge of the guide ridges 6 on the gripper will engage the upper edge of the flange 10 on the retainer. Thus the mounting of the mop is very easy, and once mounted, it is held firmly and reliably. The mop can be readily removed from the holder, too, by pulling the gripper out of the retainer and then by spreading out the grip plates. The retainer 7 presses against the grip plates over their whole length and the grip plates 3 are provided on its inner surface over the whole length with the mop stopper members which bite into the mop. This allows the gripper to be pressed against the upper part of the mop uniformly and tightly in contrast with the prior art mop holders. Since the retainer and the gripper formed are both integrally moldable, a shaft or fittings such as springs are not needed which were indispensable parts in the prior art holder. By eliminating the need for such parts, the mop holder of the present invention is much less likely to break down, lighter and can be manufactured at a much lower cost than the prior art holder.

A mop holder comprising a retainer and a mop gripper, both of them being of an inverted U-shaped section and the mop gripper being inserted in the retainer. A mop is gripped between the leg portions of the mop gripper by the engagement with stoppers formed on the inner surface of the mop gripper. The guide ridges formed on the mop gripper are adapted to engage the longitudinal flange formed on the retainer to keep the mop gripper from getting off the retainer.

CROSS-REFERENCE TO RELATED PATENT APPLICATION OR PRIORITY CLAIM [0001] This application is a Divisional of U.S. patent application Ser. No. 11/901,138, filed Sep. 13, 2007 titled “Cell Delivery Matrices”, which claims priority to U.S. Provisional Patent Application No. 60/846,468, filed Sep. 21, 2006, the contents of which are incorporated herein by reference and in their entirety. FIELD OF THE INVENTION [0002] The present disclosure relates generally to compositions and methods for improving the efficacy of cell based therapies through use of a composition that significantly mitigates migration of the cells from the site of delivery. More specifically, the present disclosure relates to cell delivery matrices that localize adipose derived endothelial cells and improve adherence of the endothelial cells to the target tissue, body cavity, or joint. BACKGROUND OF THE INVENTION [0003] In recent years, numerous therapies have been developed utilizing a variety of stem cells, presaging an emerging new specialty called regenerative medicine that promises to harness stem cells from embryonic and somatic sources to provide replacement cell therapies for genetic, malignant, and degenerative conditions. Adipose derived endothelial cells are pluripotent stem cells, having the ability to differentiate into smooth muscle or other types of cells, as described in Oliver Kocher and Joseph A. Madri, Modulation of Actin m RNA s in Cultured Vascular Cells By Matrix Components and TGF-β, In Vitro Cellular & Developmental Biology, Vol. 25, No. 5. May 1989, which is incorporated herein by reference in its entirety. As such, these cells are useful in retention or restoration of cardiac function in acute and chronic ischemia. Cells within adipose tissue can differentiate into cells expressing a cardiomyocytic or endothelial phenotype, as well as angiogenic and antiapoptotic growth factors. [0004] Direct injection or transplantation of cells may effectively restore small areas of damage, but to reconstruct severe damage to injured tissue, resulting from major coronary artery blockage, for example, will require extensive therapy with numerous differentiated cells. Such therapy is enhanced by maintaining endothelial cells at a target site for a therapeutically effective period of time, which may be from hours to days. In some embodiments, a therapeutically effective period of time is weeks to months. SUMMARY OF THE INVENTION [0005] Cell delivery matrices are described that maintain local delivery of adipose derived endothelial cells and other therapeutic agents to a target tissue, body cavity, or joint. The cell delivery matrix may be a three-dimensional matrix scaffold comprising fibrin derived from the patient's own body. The cell delivery matrix used in the methods of the invention may be degradable, bioabsorbable or non-degradable. In an embodiment, the cell delivery matrix is an artificial, FDA-approved synthetic polymer. In an embodiment, the cell delivery matrix comprises expanded polytetrafluoroethylene (ePTFE). In another embodiment, the cell delivery matrix comprises polyethyleneterephthalate (PET). The cell delivery matrix may be biocompatible and semi-permeable. The surface of the cell delivery matrix may comprise an immobilized adhesion molecule. [0006] The present disclosure provides regenerative therapies comprising implanting in the subject cell delivery matrices localizing adipose derived endothelial cells. The cell delivery matrices maintain the adipose derived endothelial cells at the target for a therapeutically effective amount of time. The adipose derived endothelial cells can be allogenic or syngenic to the subject. The endothelial cells may be delivered alone or in combination with other therapeutic agents. [0007] A skilled artisan will appreciate that the subject of the present invention may be any animal, including amphibians, birds, fish, mammals, and marsupials, but is preferably a mammal (e.g., a human; a domestic animal, such as a cat, dog, monkey, mouse, and rat; or a commercial animal, such as a cow, horse or pig). Additionally, the subject of the present invention may be of any age, including a fetus, an embryo, a child, and an adult. BRIEF DESCRIPTION OF THE FIGURES [0008] FIG. 1 depicts a cell delivery matrix. Arrows indicate localized endothelial cells and the semi-porous biomaterial. DETAILED DESCRIPTION [0009] Those of ordinary skill in the art will realize that the following detailed description is illustrative only and is not intended to be in any way limiting. Other embodiments will readily suggest themselves to such skilled persons having the benefit of this disclosure. [0010] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the content clearly dictates otherwise. All publication, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. Additionally, the section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described. All references cited in this application are expressly incorporated by reference for any purpose. [0011] U.S. Pat. No. 5,372,945, incorporated herein by reference in its entirety, discloses methods and devices that may be used for the ready isolation of large quantities of endothelial cells having the ability to differentiate into smooth muscle. According to an embodiment, subcutaneous fat is removed from a patient using modified liposuction techniques and transferred to a self-contained, closed device where the fat can be stored under sterile conditions until needed. The fat is sterilely transferred to a digestion device where it is initially washed to remove red blood cells and other debris, followed by a controlled collagenase digestion for about 20 minutes at about 37° C. The fat slurry is then transferred to an endothelial cell isolation device, again under sterile conditions, where endothelial cells sediment into an isolation device, allowing automatic retrieval of the isolated endothelial cells. The cell suspension is then sterilely transferred to a processing unit wherein the cells are rapidly filtered onto the graft surface under sterile conditions. The endothelial cell isolation and deposition process requires only about 40 minutes for completion. Following an incubation period, the graft is ready for implantation into the patient. The system yields endothelial cell product in numbers acceptable for subsequent high density seeding, e.g., in a range of about 5.14×10 6 to 4.24×10 7 cells from 50 cc of fat, and adherence to the graft surface. The apparatus deposits cells along the entire length and diameter of the graft consistently, with no significant difference in cell concentration as compared by analysis of variance. [0012] As depicted in FIG. 1 , after isolation these cells may then be localized by a cellular matrix. The cell delivery matrix that localizes the endothelial cells may be a three-dimensional culture, which is liquid, gel, semi-solid, or solid at 25° C. The three-dimensional culture may be biodegradable or non-biodegradable. [0013] The cell delivery matrix used in the methods of the invention may be comprised of any degradable, bioabsorbable or non-degradable, biocompatible polymer. Exemplary three-dimensional culture materials include polymers and hydrogels comprising collagen, fibrin, chitosan, MATRIGEL, polyethylene glycol, dextrans including chemically crosslinkable or photocrosslinkable dextrans, and the like. In an embodiment, the three-dimensional culture comprises allogeneic components, autologous components, or both allogeneic components and autologous components. In an embodiment, the three-dimensional culture comprises synthetic or semi-synthetic materials. In an embodiment, the three-dimensional culture comprises a framework or support, such as a fibrin-derived scaffold. The term scaffold is used herein to include a wide variety of three-dimensional frameworks, for example, but not limited to a mesh, grid, sponge, foam, or the like. [0014] The term “polymer” is also used herein in the broad sense and is intended to include a wide range of biocompatible polymers, for example, but not limited to, homopolymers, co-polymers, block polymers, cross-linkable or crosslinked polymers, photoinitiated polymers, chemically initiated polymers, biodegradable polymers, nonbiodegradable polymers, and the like. In other embodiments, the prevascularized construct comprises a polymer matrix that is nonpolymerized, to allow it to be combined with a tissue, organ, or engineered tissue in a liquid or semi-liquid state, for example, by injection. In certain embodiments, the prevascularized construct comprising liquid matrix may polymerize or substantially polymerize “in situ.” In certain embodiments, the prevascularized construct is polymerized or substantially polymerized prior to injection. Such injectable compositions are prepared using conventional materials and methods know in the art, including, but not limited to, Knapp et al., Plastic and Reconstr. Surg. 60:389 405, 1977; Fagien, Plastic and Reconstr. Surg. 105:362 73 and 2526 28, 2000; Klein et al., J. Dermatol. Surg. Oncol. 10:519 22, 1984; Klein, J. Amer. Acad. Dermatol. 9:224 28, 1983; Watson et al., Cutis 31:543 46, 1983; Klein, Dermatol. Clin. 19:491 508, 2001; Klein, Pedriat. Dent. 21:449 50, 1999; Skorman, J. Foot Surg. 26:511 5, 1987; Burgess, Facial Plast. Surg. 8:176 82, 1992; Laude et al., J. Biomech. Eng. 122:231 35, 2000; Frey et al., J. Urol. 154:812 15, 1995; Rosenblatt et al., Biomaterials 15:985 95, 1994; Griffey et al., J. Biomed. Mater. Res. 58:10 15, 2001; Stenburg et al., Scfand. J. Urol. Nephrol. 33:355 61,1999; Sclafani et al., Facial Plast. Surg. 16:29 34, 2000; Spira et al., Clin. Plast. Surg. 20:181 88, 1993; Ellis et al., Facila Plast. Surg. Clin. North Amer. 9:405 11, 2001; Alster et al., Plastic Reconstr. Surg. 105:2515 28, 2000; and U.S. Pat. Nos. 3,949,073 and 5,709,854. [0015] A cell delivery matrix may comprise collagen, including contracted and non-contracted collagen gels, hydrogels comprising, for example, but not limited to, fibrin, alginate, agarose, gelatin, hyaluronate, polyethylene glycol (PEG), dextrans, including dextrans that are suitable for chemical crosslinking, photocrosslinking, or both, albumin, polyacrylamide, polyglycolyic acid, polyvinyl chloride, polyvinyl alcohol, poly(n-vinyl-2-pyrollidone), poly(2-hydroxy ethyl methacrylate), hydrophilic polyurethanes, acrylic derivatives, pluronics, such as polypropylene oxide and polyethylene oxide copolymer, or the like. The fibrin or collagen may be autologous or allogeneic with respect to the patient. The matrix may comprise non-degradable materials, for example, but not limited to, expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polyethyleneterephthalate (PET), poly(butylenes terephthalate (PBT), polyurethane, polyethylene, polycabonate, polystyrene, silicone, and the like, or selectively degradable materials, such as poly (lactic-co-glycolic acid; PLGA), PLA, or PGA. (See also, Middleton et al., Biomaterials 21:2335 2346, 2000; Middleton et al., Medical Plastics and Biomaterials, March/April 1998, at pages 30 37; Handbook of Biodegradable Polymers, Domb, Kost, and Domb, eds., 1997, Harwood Academic Publishers, Australia; Rogalla, Minim. Invasive Surg. Nurs. 11:67 69, 1997; Klein, Facial Plast. Surg. Clin. North Amer. 9:205 18, 2001; Klein et al., J. Dermatol. Surg. Oncol. 11:337 39, 1985; Frey et al., J. Urol. 154:812 15, 1995; Peters et al., J. Biomed. Mater. Res. 43:422 27, 1998; and Kuijpers et al., J. Biomed. Mater. Res. 51:136 45, 2000). [0016] The surface of the cell delivery matrix may comprise an immobilized adhesion molecule, as described in U.S. Pat. No. 5,744,515, incorporated herein by reference in its entirety. In certain embodiments the immobilized adhesion molecule is selected from the group consisting of fibronectin, laminin, and collagen. The adhesion molecules may be immobilized to the surface, including the pores of the surface, of the matrix by means of photochemistry. [0017] The cell delivery matrix, in addition to localizing endothelial cells, may localize at least one cytokine, at least one chemokine, at least one antibiotic, such as an antimicrobial agent, at least one drug, at least one analgesic agent, at least one anti-inflammatory agent, at least one immunosuppressive agent, or various combinations thereof. The at least one cytokine, at least one antibiotic, at least one drug, at least one analgesic agent, at least one anti-inflammatory agent, at least one immunosuppressive agent, or various combinations thereof may comprise a controlled-release format, such as those generally known in the art, for example, but not limited to, Richardson et al., Nat. Biotechnol. 19:1029 34, 2001. [0018] Exemplary cytokines include angiogenin, vascular endothelial growth factor (VEGF, including, but not limited to VEGF-165), interleukins, fibroblast growth factors, for example, but not limited to, FGF-1 and FGF-2, hepatocyte growth factor, (HGF), transforming growth factor beta (TGF-.beta.), endothelins (such as ET-1, ET-2, and ET-3), insulin-like growth factor (IGF-1), angiopoietins (such as Ang-1, Ang-2, Ang-3/4), angiopoietin-like proteins (such as ANGPTL1, ANGPTL-2, ANGPTL-3, and ANGPTL-4), platelet-derived growth factor (PDGF), including, but not limited to PDGF-AA, PDGF-BB and PDGF-AB, epidermal growth factor (EGF), endothelial cell growth factor (ECGF), including ECGS, platelet-derived endothelial cell growth factor (PD-ECGF), placenta growth factor (PLGF), and the like. Cytokines, including recombinant cytokines, and chemokines are typically commercially available from numerous sources, for example, R & D Systems (Minneapolis, Minn.); Endogen (Woburn, Wash.); and Sigma (St. Louis, Mo.). The skilled artisan will understand that the choice of chemokines and cytokines for incorporation into particular prevascularized constructs will depend, in part, on the target tissue or organ to be vascularized or revascularized. [0019] In certain embodiments, the cell delivery matrix further localizes at least one genetically engineered cell. Descriptions of exemplary genetic engineering techniques can be found in, among other places, Ausubel et al., Current Protocols in Molecular Biology (including supplements through March 2002), John Wiley & Sons, New York, N.Y., 1989; Sambrook et al., Molecular Cloning: A Laboratory Manual, 2.sup.nd Ed., Cold Spring Harbor Laboratory Press, Cold Spring Harbor, N.Y., 1989; Sambrook and Russell, Molecular Cloning: A Laboratory Manual, 3.sup.rd Ed., Cold Spring Harbor Laboratory Press, Cold Spring Harbor, N.Y., 2001; Beaucage et al., Current Protocols in Nucleic Acid Chemistry, John Wiley & Sons, New York, N.Y., 2000 (including supplements through March 2002); Short Protocols in Molecular Biology, 4.sup.th Ed., Ausbel, Brent, and Moore, eds., John Wiley & Sons, New York, N.Y., 1999; Davis et al., Basic Methods in Molecular Biology, McGraw Hill Professional Publishing, 1995; Molecular Biology Protocols (see the highveld.com website), and Protocol Online (protocol-online.net). Exemplary gene products for genetically modifying the genetically engineered cells of the invention include, plasminogen activator, soluble CD4, Factor VIII, Factor IX, von Willebrand Factor, urokinase, hirudin, interferons, including alpha-, beta- and gamma-interferon, tumor necrosis factor, interleukins, hematopoietic growth factor, antibodies, glucocerebrosidase, adenosine deaminase, phenylalanine hydroxylase, human growth hormone, insulin, erythropoietin, VEGF, angiopoietin, hepatocyte growth factor, PLGF, and the like. [0020] In certain embodiments, a cell delivery matrix further comprises appropriate stromal cells, stem cells, or combinations thereof. As used herein, the term “stem cells” includes traditional stem cells, progenitor cells, preprogenitor cells, reserve cells, and the like. Exemplary stem cells include embryonic stem cells, adult stem cells, pluripotent stem cells, neural stem cells, liver stem cells, muscle stem cells, muscle precursor stem cells, endothelial progenitor cells, bone marrow stem cells, chondrogenic stem cells, lymphoid stem cells, mesenchymal stem cells, hematopoietic stem cells, central nervous system stem cells, peripheral nervous system stem cells, and the like. Descriptions of stem cells, including method for isolating and culturing them, may be found in, among other places, Embryonic Stem Cells, Methods and Protocols, Turksen, ed., Humana Press, 2002; Weisman et al., Annu Rev. Cell. Dev. Biol. 17:387 403; Pittinger et al., Science, 284:143 47, 1999; Animal Cell Culture, Masters, ed., Oxford University Press, 2000; Jackson et al., PNAS 96(25):14482 86, 1999; Zuk et al., Tissue Engineering, 7:211 228, 2001 (“Zuk et al.”); Atala et al., particularly Chapters 33 41; and U.S. Pat. Nos. 5,559,022, 5,672,346 and 5,827,735. Descriptions of stromal cells, including methods for isolating them, may be found in, among other places, Prockop, Science, 276:71 74, 1997; Theise et al., Hepatology, 31:235 40, 2000; Current Protocols in Cell Biology, Bonifacino et al., eds., John Wiley & Sons, 2000 (including updates through March, 2002); and U.S. Pat. No. 4,963,489. [0021] Therapeutic agents that can also be localized by the cell delivery matrix may include Transforming Growth Factor beta (TGFβ) and TGF-β-related proteins for regulating stem cell renewal and differentiation. [0022] Further therapeutic agents that may be used include anti-thrombogenic agents or other agents for suppressing stenosis or late restenosis such as heparin, streptokinase, urokinase, tissue plasminogen activator, anti-thromboxane B 2 agents, anti-B-thromboglobulin, prostaglandin E, aspirin, dipyridimol, anti-thromboxane A 2 agents, murine monoclonal antibody 7E3, triazolopyrimidine, ciprostene, hirudin, ticlopidine, nicorandil, and the like. Anti-platelet derived growth factor may be used as a therapeutic agent to suppress subintimal fibromuscular hyperplasia at an arterial stenosis site, or any other inhibitor of cell growth at the stenosis site may be used. [0023] Other therapeutic agents that may be used in conjunction with endothelial cells may comprise a vasodilator to counteract vasospasm, for example an antispasmodic agent such as papaverine. The therapeutic agents may be vasoactive agents generally such as calcium antagonists, or alpha and beta adrenergic agonists or antagonists. Additionally, the therapeutic agent may be an anti-neoplastic agent such as 5-fluorouracil or any known anti-neoplastic agent, preferably mixed with a controlled release carrier for the agent, for the application of a persistent, controlled release anti-neoplastic agent to a tumor site. [0024] The therapeutic agent may be an antibiotic, which may be applied to an infected stent or any other source of localized infection within the body. Similarly, the therapeutic agent may comprise steroids for the purpose of suppressing inflammation or for other reasons in a localized tissue site. [0025] Additionally, glucocorticosteroids or omega-3 fatty acids may be localized by the cell delivery matrix, particularly for stenosis applications. Any of the therapeutic agents may include controlled release agents to prolong the persistence. [0026] The therapeutic agent may constitute any desired mixture of individual pharmaceuticals of the like, for the application of combinations of active agents. The pharmaceutical agent may support the survival of the cell (e.g., a carbohydrate, a cytokine, a vitamin, etc.). The cell delivery matrix can be delivered to the target tissue, body cavity, or joint by any local delivery means known in the art. Applicant's provisional application 60/841,009, entitled “Catheter for Cell Delivery,” incorporated herein by reference in its entirety, discloses methods and apparatuses suitable for local delivery of the cell delivery matrices of the present disclosure. In an embodiment, the cell delivery system used to deliver the cells locally comprises a catheter. The catheter may comprise an inner bladder and an outer perforated bladder that permits localized delivery of stem cells. The inner bladder may be expanded through the use of a pressure conduit in order to deploy a stent. Cell matrices comprising endothelial cells may be introduced between the inner and outer bladder. The inner bladder may be further expanded in order to exert pressure on the outer perforated bladder to advance the cells though the apertures of the outer bladder. The inner bladder may remain pressurized to hold the outer bladder against the vessel wall, thereby directing the cells to specific target sites. In an embodiment, a three-dimensional matrix scaffold comprising fibrin is delivered locally without cells, in accordance with the methods disclosed in Application Number 60/841,009. [0027] Further modifications and alternative embodiments of various aspects of the invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the invention. It is to be understood that the forms of the invention shown and described herein are to be taken as the presently preferred embodiments. Elements and materials may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the invention may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of this description of the invention. Changes may be made in the elements described herein without departing from the spirit and scope of the invention as described in the following claims.

Cell delivery matrices and methods for facilitating local delivery of adipose derived endothelial cells to a target tissue, body cavity, or joint are described. The cell delivery matrix may be a three-dimensional matrix scaffold comprising fibrin derived from the patient's own body. The cell delivery matrix may be biocompatible and semi-permeable. The cell delivery matrix used in the methods of the invention may be comprised of any degradable, bioabsorbable or non-degradable, biocompatible polymer. Regenerative therapies comprising implanting in the subject cell delivery matrices localizing adipose derived endothelial cells are described. The cell delivery matrices maintain the adipose derived endothelial cells at the target for a therapeutically effective amount of time. The adipose derived endothelial cells can be allogenic or syngenic to the subject. The endothelial cells may be delivered alone or in combination with other therapeutic agents.

FIELD OF THE INVENTION [0001] This invention relates to a drug delivery needle and more specifically to a needle for percutaneous injection of a drug into an implanted drug delivery device having a catheter for drug delivery to a patient. BACKGROUND OF THE INVENTION [0002] Drug delivery devices are commonly implanted in a patient for long-term administration of drugs. These devices generally include a chamber with a self-sealing silicone septum and a catheter attached to the chamber and positioned for delivery of the drug to a suitable location, for example, into a vein. The chamber contains the drug for delivery to the patient through the catheter and is implanted such that the septum is located just under the skin of the patient. In order to access the chamber, the patient's skin and the septum of the drug delivery device are pierced using a needle and the drug is introduced into the chamber by injection using a syringe or other delivery device. [0003] Conventional hypodermic needles are not used for the introduction of a drug to a drug delivery device for various reasons including, for example, the possibility that these needles can damage the septum. Instead, specially designed needles are used to pierce the skin and the septum. These needles include a right angle bend (approximately a ninety degree bend) for convenient access to the chamber and are designed to inhibit coring of the septum and ensure penetration of the skin and septum at approximately ninety degrees. The needles are appropriately sized to access the chamber of the device. A portion of the needle lies approximately parallel with the surface of the skin of the patient, to allow the needle to be taped down. [0004] While they are an improvement over conventional needles, right-angle needles can still be somewhat difficult to hold and to push through the skin and the septum since the physician must firmly grasp the needle in order to drive the needle through the septum. Also, when taped down on the patient, prior art needles do not allow flow of air around the wound site. This can contribute to infection of the wound. [0005] One particular prior art drug delivery needle is disclosed in U.S. Pat. No. 4,743,231, issued May 10, 1988 to Kay et al. This patent teaches a right angle drug administration needle with a rigid base for taping down to the skin of a patient and a releasably connectable handle for ease of handling. A foam pad extends around the periphery of the underside of the base and includes an adhesive surface for adhering to the skin of the patient. A low profile allows for the right angled needle device to be taped down to the user while the foam pad provides flow of air around the wound site. [0006] Although this structure provides a handle for firmly grasping the needle and a foam pad for flow of air around the wound site, the drug delivery needle device still suffers from some disadvantages. The handle is molded separately from the remainder of the needle device and is releasable to provide a low profile when the device is taped down. Thus, when the tape is removed from the patient, the physician is required to find the handle and attach the handle to the base in order to remove the needle. Since the handle is removable, it can easily be misplaced or lost. Also, the base is rigid and does not conform to the skin surface of the patient. [0007] Accordingly, it is an object of an aspect of the present invention to provide a drug delivery needle for percutaneous delivery of a drug into an implanted drug delivery device that obviates or mitigates at least one of the disadvantages of the prior art. SUMMARY OF THE INVENTION [0008] In one aspect of the present invention there is provided a needle device for percutaneous drug delivery to a patient. The device comprises a substantially L-shaped, hollow needle for drug delivery therethrough and a body. The needle includes a needle end and the body is secured to the needle and longitudinally spaced from the needle end. The body includes an integral pair of flexible handles adapted to be grasped for insertion of the needle device into and removal of the device from the patient. [0009] Advantageously, the handles of the drug delivery device are attached to the remainder of the device. Also, the drug delivery device includes a spacer that spaces the handles away from the wound site when the drug delivery device is taped down on the patient. In an aspect of the invention, a portion of the L-shaped needle extends approximately from the center of a body between the pair of flexible handles. Thus, downward force on the body of the device is transmitted to the needle when the needle is inserted into the patient. This provides support and accuracy during insertion of the needle. BRIEF DESCRIPTION OF THE DRAWINGS [0010] The invention will be better understood with reference to the drawings, and following description, in which: [0011] [0011]FIG. 1 is a perspective view of a needle device according to a preferred embodiment of the present invention; [0012] [0012]FIG. 2 is an alternative perspective view of the needle device of FIG. 1; [0013] [0013]FIG. 3 is a cross-sectional front view of the needle device of FIG. 1 showing the device in use with a needle inserted into a chamber (shown in ghost outline) under the skin of a patient and showing a pair of handles, flexed in opposing directions in ghost outline; [0014] [0014]FIG. 4 is a bottom view of the needle device of FIG. 1, showing the needle in cross-section; [0015] [0015]FIG. 5 is a perspective view of the needle device of FIG. 1, showing the handles being grasped; and [0016] [0016]FIG. 6 is a front view of the needle device of FIG. 5, showing the handles being grasped. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0017] Reference is first made to FIGS. 1 and 2 to describe a preferred embodiment of a drug delivery needle device designated generally by the numeral 20 . The drug delivery needle device includes a substantially L-shaped needle 22 for drug delivery therethrough. The needle 22 consists of first portion 24 and a second portion 26 with an included angle between the first portion 24 and second portion 26 , forming the L-shape. In the present embodiment, the included angle is approximately ninety degrees. The needle 22 is hollow to define a continuous fluid passage through the first and second portions 24 , 26 , respectively. The first portion 24 of the needle 22 is attached to a flexible tube and will be described further below. The second portion 26 of the needle 22 includes a needle end 30 that is slightly bent with respect to the remainder of the second portion 26 and is longitudinally spaced from the first portion 24 . The end 30 is bent to provide a non-coring needle, as will be understood by those of skill in the art. As shown in the figures, the continuous fluid passage is open at the needle end 30 and the needle end 30 is sharp for piercing the skin of a patient and for piercing a septum of a chamber of a catheter, for example. [0018] A body 32 is molded of a resiliently flexible plastic around the first and second portions 24 , 26 , respectively. The body 32 includes a substantially rectangular base 34 , a spacer 36 , a pair of flexible handles 38 , 39 and a cover 40 , as discussed further below. [0019] The substantially rectangular base 34 is molded around the second portion 26 and is longitudinally spaced from the end 30 such that the second portion 26 of the needle 22 passes through and extends from the base 34 . A foam pad 42 extends around the periphery of one side of the base 34 . The foam pad 42 is an open-celled plastic foam to allow air flow therethrough, thereby providing a layer that allows the flow of air between the molded plastic base 34 and the skin of a patient when in use. In the present embodiment, the foam pad and base are flexible for patient comfort. [0020] One end 44 of the spacer 36 is coupled to a second side of the base 34 and the opposing end 46 is coupled to the cover 40 . It can be seen that the first portion 24 of the needle 22 extends through the cover 40 such that the cover 40 and the first portion 24 form a rigid spine 48 that provides rigidity for the device 20 . The second portion 26 of the needle 22 extends through the spacer 36 and the base 34 . As shown in FIGS. 1, 2 and 3 , the second portion 26 of the needle 22 extends longitudinally and is approximately perpendicular to the base 34 , while the spine 48 is approximately parallel with the base 34 . [0021] Referring to FIG. 3, each of the flexible handles 38 , 39 extends laterally from and is coupled to the spine 48 such that the spine 48 is located between the handles 38 , 39 . The spine 48 effectively couples the handles 38 , 39 to the spacer 36 which spaces the handles 38 , 39 from the base 34 . Each of the handles 38 , 39 includes a groove 50 , 52 , respectively, extending along the width of the handles 38 , 39 , adjacent the spine 48 . The handles 38 , 39 also include distal ends 54 , 56 , respectively, that are laterally spaced from the spine 48 and the grooves 50 , 52 . These grooves 50 , 52 provide a thin region in comparison with the remainder of the handles 38 , 39 . This provides increased flexibility in this region. In order to grasp the device 20 , the handles 38 , 39 are flexed away from the base 34 such that backsides 58 , 60 of each of the respective handles 38 , 39 are in contact with each other at the distal ends 54 , 56 . Thus, the handles 38 , 39 are effectively pinched together when grasped, as best shown in FIGS. 5 and 6. When no longer grasped, the handles 38 , 39 return to their laterally extending state. As shown in the Figures, the second portion 26 of the needle 22 extends approximately from the center of the body 32 , between the pair of flexible handles, 38 , 39 . [0022] The handles 38 , 39 can also flex in the opposite direction. It will be appreciated that the handles 38 , 39 are spaced from the base 34 in order to inhibit contact of the handles 38 , 39 with a patient's skin proximal the wound site when the device 20 is in use. [0023] Referring again to FIG. 1, a flexible tube 62 is connected to and in fluid communication with the first portion 24 of the needle 22 . The tube 62 extends outwardly from the spine 48 . The flexible tube 62 is made of a suitable plastic for delivery of a drug through the tube 62 , into the first portion 24 of the needle. 5 [0024] Although each of these elements are described separately, it will be appreciated that in the present embodiment the base 34 , the spacer 36 , the handles 38 , 39 and the cover 40 are a unitary molded plastic. [0025] The use of the drug delivery device 20 will now be described with reference to FIGS. 3 to 6 . For the purpose of the present description, a chamber with a self-sealing septum, shown in ghost outline in FIG. 3, is implanted such that the chamber is located just under the skin of the patient. The chamber is designed to contain the drug for delivery to the patient through a catheter. The use of a chamber and self-sealing septum is understood in the art and will not be further described herein. [0026] In order to access the chamber, the patient's skin and the septum are pierced using the device 20 . To accomplish this, the handles 38 , 39 of the device 20 are flexed by pinching the handles 38 , 39 , preferably between the thumb and the forefinger, such that they are in contact with each other at the distal ends 54 , 56 of the backsides 58 , 60 , as shown in FIGS. 5 and 6. Next, the needle end 30 is positioned at the desired location on the skin of the patient (at the location of the self-sealing septum). Pressure is then applied towards the surface of the skin causing the end 30 of the needle 22 to puncture the skin and the self-sealing septum of the chamber. It will be appreciated that the spine 48 provides rigidity to the device 20 when the needle 22 is being inserted or extracted from a patient. As stated above, the second portion 26 of the needle 22 extends approximately from the center of the body 32 , between the pair of flexible handles, 38 , 39 . The needle is inserted until the foam pad 42 is adjacent the patient's skin. With the needle end 30 located in the chamber, the fluid or drug is then delivered to the chamber through the flexible tube 62 , through the first and second portions 24 , 26 , respectively and out the needle end 30 . [0027] It may be desirable to leave the device 22 with the end 30 of the needle 22 inserted into the chamber for a long period of time. In such case, the device is generally taped to the skin of the patient. Thus, the handles 38 , 39 are flexed in the direction of the skin of the patient. Since the spacer 36 spaces the handles 38 , 39 from the base 34 , the handles are effectively inhibited from contacting the skin of the patient immediately around the foam pad 42 on the base 34 . The foam pad 42 allows for the flow of air around the wound site (where the needle puncture is located). [0028] To remove the device 20 , any tape that has been used to secure the device 20 is first removed. The handles 38 , 39 are then grasped, as discussed above, and pulled outwardly, away from the patient. Thus, the needle 22 is removed from the patient and the septum of the chamber seals. [0029] While the embodiment discussed herein is directed to a particular implementation of the present invention, it will be apparent that variations and modifications to this embodiment are possible. For example, the L-shaped needle can have any suitable included angle and can vary from ninety degrees. Also, the body structure described above does not need to be a unitary molded structure and can be individual pieces coupled together. The size and shape of many of the parts can vary while still performing the same function. All of these variations and modifications are within the scope sphere of the invention as defined by the claims appended hereto.

There is provided a needle device for percutaneous drug delivery to a patient. The device comprises a substantially L-shaped, hollow needle for drug delivery therethrough and a body. The needle includes a needle end and the body is secured to the needle and longitudinally spaced from the needle end. The body includes an integral pair of flexible handles adapted to be grasped for insertion of the needle device into and removal of the device from the patient.

This invention relates to a novel electrosurgical handpiece for receiving an electrosurgical electrode for use in electrosurgical medical, dental, and veterinarian procedures. BACKGROUND OF THE INVENTION Electrosurgery is a common procedure for dentists, doctors, and veternarians. Electrosurgical unipolar handpieces are commercially available that will accommodate a wide variety of electrodes shapes and sizes, such as needles, blades, scalpels, balls and wire loops. The conventional unipolar handpiece, such as that available from Ellman International, Inc. of Hewlett, N.Y. comprises an elongated electrically-insulating handle with a central bore and having at a first end an externally threaded part for threadingly engaging an internal thread on an electrically-insulating nose piece also fitted with a central bore. A generally cylindrical metal collet seats in the handle bore at the first end and a collet front portion projects forward from the handle. The collet comprises at its front portion flexible jaws formed by a tapered slitted front with a bore sized to receive the shaft or shank of a conventional electrosurgical electrode, and the nose piece has on its interior a matching tapered portion configured such that, when the nose piece is rotated clockwise (CW) while threadingly engaged to the handle, its tapered interior surface engages and gradually closes down the collet jaws so that the electrode, when inserted into the collet bore, is tightly held by the metal collet and a good electrical connection is made to the collet. The back end of the collet is connected to a wire which connects to a conventional electrosurgical instrument supplying electrosurgical currents which, when activated, via a switch on the handpiece or a foot switch or a switch on the instrument, supplies electrosurgical currents to the collet and via the collet to the electrosurgical electrode. When the dentist or doctor desires to change the shape, size or length of the electrode, it is necessary to loosen the nose piece to unlock the collet, remove the existing electrode, and substitute a new electrode. This known handpiece, at times, can cause problems, mainly associated with the nose piece if the users are not careful. In the conventional handpiece, the nose piece is easily removable from the handle by rotating the nose piece counterclockwise (CCW). Removability, as such, may not be necessary in many situations. What is necessary, however, is that the nose piece is rotatable so that when rotated in one direction it will lock an electrode to the handpiece, and when rotated in the opposite direction it will unlock the electrode so that the electrode can be removed and replaced with another electrode. Many electrosurgical procedures require the use of several electrodes, so a handpiece is needed that will allow rapid changes of electrodes with minimum effort. The Ellman handpiece is noted for this quality. But, the ease of replacing electrodes has introduced the problem that the surgeon or assistant may not always ensure that the nose piece is properly on and properly tightened to the handle, with the result that on occasion the nose piece will detach from the handle. In most cases, this is not a serious problem, but in some case, if the nose piece detaches while the handpiece is in a patient cavity, harm could result. For example, if the cavity happens to be the mouth of the patient, the nose piece if accidentally detached may be swallowed. Another disadvantage is that if the nose piece detaches, then it or the collet may be misplaced and be unavailable when needed. SUMMARY OF THE INVENTION An object of the invention is an electrosurgical handpiece that can accept various shapes and sizes of electrodes by the simple expedient of rotating a nose piece, and that is capable of locking the nose piece to the handle while still allowing the nose piece to rotate sufficiently to lock and unlock the shaft of a conventional electrosurgical electrode to the handpiece. Another object of the invention is an electrosurgical handpiece comprising separable parts including a handle, collet, and nose piece, wherein the separable parts, when assembled, are automatically locked together. According to one aspect of the invention, an electrosurgical handpiece comprises a handle and a nose piece for threaded engagement with the handle, together with a collet member which cooperates with the handle and nose piece for removably receiving and locking an electrosurgical electrode to the handle. The mating handle and nose piece are provided with locking structure adjacent their threaded portions which will prevent the nose piece from detaching from the handle while still allowing it to rotate sufficiently to cause the collet to lock and unlock to an electrode. In a preferred embodiment, the locking structure comprises on one of the mating members a first ridge behind its threaded portion and behind the first ridge a channeled region for receiving a second ridge on the the other of the mating members and located behind its threaded portion. In a further preferred embodiment according to the invention, each of the mating members are provided with a ridge and an adjacent channeled region, with the ridge and adjacent channeled region on both of the mating members being located behind their respective threaded portion. For one of the mating members, the channeled region is located behind the ridge, whereas for the other of the mating members, the channeled region is located in front of the ridge. As used herein, terms that define position are being related to the handpiece handle which possesses a longitudinal axis, and "front" means in a direction toward the electrode end of the handpiece whereas "behind " or to the "rear" means in a direction away from the electrode end of the handpiece. Since the novel electrosurgical handpiece construction allows the use of a conventional collet, all standard electrodes can be employed to which can be attached the shaft of an electrosurgical handpiece and which can thus removably receive any one of a family of electrodes capable of performing an electrosurgical function. 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 use, reference should be had to the accompanying drawings and descriptive matter in which there are illustrated and described the preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 is a perspective view of one form of an electrosurgical handpiece according to the invention shown with an electrode and shown schematically connected to an electrosurgical instrument for supply of electrosurgical currents; FIG. 2 is an exploded view of the electrosurgical handpiece shown in FIG. 1; FIG. 3 illustrates one form of a collet used in the electrosurgical handpiece of the invention; FIG. 4 illustrates one form of a nose piece used in the electrosurgical handpiece of the invention; FIG. 5 illustrates one form of a handle used in the electrosurgical handpiece of the invention. The figures are not to the same scale. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1 and 2 show a preferred embodiment of an electrosurgical handpiece of the invention. The handpiece 8 comprises a straight, elongated, round handle 10 made, for example, of Delrin plastic, and provided with a bore 9 that extends throughout its length. A longitudinal axis is indicated by 6. At its left or front end is a reduced diameter cylindrical section that forms a first channeled region 14 with a cylindrical floor 16 and defined by a flanking shoulder 18 on the right and a flanking first ridge 20 on the left. The first ridge 20 is adjacent a forwardly projecting threaded portion 22. A metal or otherwise electrically-conductive collet 24 has a rear cylindrical section 26 with a bore 28, located behind a shoulder 30, in turn behind a reduced diameter section 32 behind a standard collet head 34. The collet head 34 comprises at its left end jaws formed by a tapered part 36 that has 4 slots 38 extending radially from the outside to a bore 40. A nose piece is shown at 44, and comprises an electrically-insulating cylindrical member, for example, of Delrin, having a central bore 48. At its left, the nose piece 44 tapers down toward its bore to form a snout 50. At its right end, inside of the bore is located a second channeled region 52 with a cylindrical floor 54 flanked at its rear by a second ridge 56. Between the second channeled region 52 and the tapered front 50 is an internally threaded portion 58, matched to the threaded portion 22 on the handle. The three pans 10, 24, and 44 making up the handpiece 8 are also shown in enlarged views in FIGS. 3-5. During the assembly process, an electrical cable 60 whose distal end is fitted with a banana plug 62 is threaded through the handle bore 9 and its free wire end soldered into the bore 28 at the rear of the collet 24, shown at 64. The cable with attached collet is then pulled to the right until stopped by the shoulder 30 with the collet rear portion 26 seating in the bore 9 within the threaded portion 22. Then, the nose piece 44 is fitted over the tapered collet end 34 and over the threaded portion 22 until the latter is engaged by the threaded portion 58 on the nose piece, and the nose piece piece 44 is then rotated CW to threadingly engage the mating threaded portions 22, 58. After about 8-10 turns, the second ridge 56 at the rear of the nose piece engages the first ridge 20 on the handle front end. At that point, the nose piece, with ordinary force, cannot be rotated any further. In accordance with the invention, the ridge 56 has a bevelled rear end 66, and is configured and sized relative to the size of the ridge 20 that a much stronger force will force the second ridge 56 over the first ridge 20 and into the first channeled region 14. Simultaneously, the first ridge 20 will then be located in the second channeled region 52. Both channeled regions 14, 52 are configured and sized such that there is clearance between the innermost ridge surface and the respective channeled region floor in which it is now positioned so that the nose piece rotates freely. The length of each channeled region 14, 52, in the axial direction is such that the nose piece 44 can then be rotated at least an additional 6-10 turns such that, before it has reached the end of its travel, an interior tapered section 70 will engage the tapered front 36 of the collet 24 thereby forcing inward the collet jaws 72 defined by the slits 38. An electrode 74 whose shaft is inserted in the bore 40 of the collet will then be tightly held by the collet jaws 72 which will prevent further rotation of the nose piece 44. In the assembled condition, the electrically-insulating nose piece 44 covers the metal collet 24 except for the working end of the electrode 74 which projects forwardly from the front end of the handpiece. To ease rotation of the nose piece 44, the surface may be knurled as shown at 76. When the plug 62 is plugged into a conventional electrosurgical instrument 80 and the instrument activated, electrosurgical currents will flow from the instrument via the cable 60 to the handpiece 8, and via the collet 24 to the electrode 74. When it is desired to remove or replace the electrode, the nose piece 44 is rotated CCW. Sufficient rotation of the nose piece 44 is allowed by the axial length of the channeled regions to allow the natural resilience of the metal of the collet jaws 72 to relax to release the electrode which can then be withdrawn from the handpiece. However, further CCW rotation of the nose piece 44 which would allow it to be detached from the handle is prevented by the non-bevelled side 82 of the second ridge 56 which engages the rear side of the first ridge 20. Thus, the nose piece has sufficient room to rotate enough turns to allow an electrode to be tightly or loosely held and removable from the handpiece, but the nose piece cannot be detached from the handpiece because of the interfering ridges 20, 56. A feature of the invention is that for the nose piece to be able to compress the collet jaws to hold an electrode, the respective first and second ridges must be located in their respective second and first channeled regions. In other words, in order for the handpiece to operate as intended, the nose piece will always be in its locked state. Put still another way, the nose piece is automatically locked to the handle with the collet in place when the handpiece is assembled at the factory and before it reaches the user. Successful operation depends on a suitable relationship of the size of the ridges and their adjoining channeled regions. For a conventional sized handpiece, whose length from the snout 50 in front to the rear of the handle where the cable emerges is about 5 inches(assembled), the first channeled region 14 has an axial length of about 0.1-0.3, preferably about 0.157, inches; the height of the first ridge 20 is about 0.02-0.04, preferably about 0.03, inches; and the length of the threaded portion 22 about 0.2-0.4, preferably about 0.3, inches; the second channeled region 52 has an axial length of about 0.15-0.5, preferably about 0.25, inches; the height of the second ridge 56 is about 0.04-0.07, preferably about 0.057, inches; and the length of the threaded portion 58 about 0.5-0.8, preferably about 0.69, inches. The preferred dimensions are for 5/16-24 threads. For a coarser thread pitch, the channeled regions would need to be longer, and for a finer thread, the channeled regions could be shorter. The interference between the two ridges is about 0.005 inches. This is sufficient to allow one to ride over the other when sufficient torque is applied during assembly, yet prevent their detachment during normal use. In the preferred example given, the axial length of the first channeled region 14, being shorter than that of the second channeled region 52, governs the number of turns possible of the nose piece 44. What is not shown in the drawings are the standard switches that can be added to the handpiece so that the electrode can be turned on and off by the surgeon using the handpiece switches. Also not shown is the standard footswitch which also plugs into the electrosurgical instrument 80 for operating the handpiece. The bore 40 of the collet 24 is sized to receive the metal shank (not shown) of an electrosurgical electrode 74. Conventional electrodes frequently come in different-sized shanks, for example, 1/16", 3/32", or 1/8". To accommodate the different sized electrodes, the handpiece when assembled can be fitted with the sized collet desired. Thus, a separate handpiece will be required for each different size of electrode shank. Typically, the collet outer dimensions are unchanged, only its bore size. In this way, each handpiece is custom sized for each type of electrode. In all cases, an electrical connection is established between the electrode conductive portions and the cable 60. The particular electrode 74 shown in FIG. 1 has an active or working end in the form of a needle. Other shapes are of course possible, such as wire loops and balls. While the parts of the electrosurgical handpiece, made up of metal and Delrin, are auto-clavable, the device is sufficiently simple that it can be manufactured at very low cost with a less expensive plastic and thus can be made disposable. While the invention has been described in connection with preferred embodiments, it will be understood that modifications thereof within the principles outlined above will be evident to those skilled in the art and thus the invention is not limited to the preferred embodiments but is intended to encompass such modifications.

An electrosurgical handpiece comprises a handle and a nose piece for threaded engagement with the handle, together with a collet member which cooperates with the handle and nose piece for removably receiving and locking an electrosurgical electrode to the handle. The mating handle and nose piece are provided with locking structure adjacent their threaded portions which will automatically lock the nose piece to the handle when assembled and thus prevent the nose piece from detaching from the handle while still allowing the nose piece when the electrosurgical handpiece is in use to rotate sufficiently to cause the collet to lock and unlock to an electrode.

[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 11/398,161, filed Apr. 4, 2006, and claims the priority of provisional patent application Nos. 60/708,206, filed Aug. 15, 2005, and 60/668,022, filed Apr. 4, 2005, the entire contents of each of which is incorporated herein by reference. GOVERNMENT RIGHTS [0002] This invention was made with Government support under Grant No. N00014-04-1-0654, awarded by the Office of Naval Research. The Government has certain rights in this invention. [0003] Throughout this application various publications are referenced. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains. TECHNICAL FIELD OF THE INVENTION [0004] The invention disclosed herein relates to compositions and methods for modulating the blood coagulation cascade, accelerating bone generation, and assisting in wound healing and body repair. Both the materials selected for the hemostatic composition and the method for regulating hemostasis provide novel means for predictable control over blood coagulation, allowing for both accelerating and slowing or stopping blood flow. BACKGROUND OF THE INVENTION [0005] U.S. Pat. No. 4,822,349 issued to Hursey, et. al. describes reduction of blood flow by application of a dehydrated zeolite material to the site of blood flow. In this method, a particular calcium rich zeolite formulation of the class Linde Type 5A has been utilized as an external application to a traumatically wounded individual to induce hemostasis through dehydration of the wounded area and induction of a blood clot formation (Breck, D W et al., J Am. Chem. Soc. 78, 23 (1956) 5963.). A major disadvantage to this product has been the excessive heat generated locally at the injured site as a consequence of the large enthalpy of hydration associated with the material currently marketed under the trade name, QuikClot™ and distributed Z-medica corporation of Newington, Conn. USA. There remains a need for modifications and improvements that optimize the enthalpy of hydration upon rehydration of the dehydration zeolite. [0006] Bioactive glasses (BGs) with SiO 2 —CaO—P 2 O 6 —MO (M=Na, Mg, etc.) compositions were invented by Hench in 1971 (L. L. Hench et al., J. Biomed. Mater. Res. 1971, 2:117) and have been widely studied and used in clinical applications for bone and dental repair due to their chemical bonding with both soft and hard tissue through an apatite-like layer. The apatite-like layer promotes the adhesion of bioactive glass to tissues and avoids the formation of an intervening fibrous layer. This has been shown to decreases the failure possibilities of prostheses and influence the deposition rate of secondary bone and tissue growth. In vivo implantation studies demonstrate that these compositions produce no local or systemic toxicity, are biocompatible, and do not result in an inflammatory response. The SiO 2 —CaO—P 2 O 5 —MO BG system has been synthesized by the melting-quenching method (Hench et al., 1971, supra) or by the sol-gel method (P. Sepulveda et al., J. Biomed. Mater. Res. 2002, 59:340; P. Saravanapavan and I. I. Hench, J. Biomed. Mater. Res. 2001, 54:608). Compared with the traditional melting-quenching method, sol-gel techniques were developed in the past decade to produce the same material at a lower working temperature. Sol-gel techniques also allow a greater degree of functionalization to be incorporated into the bioactive glass material to increase the rate of apatite-like layer growth as well as afford a wider range of bioactivity. SUMMARY OF THE INVENTION [0007] The invention provides a homogeneous composition comprising a hemostatically effective amount of a charged oxide, wherein the composition has an isoelectric point, as measured in a calcium chloride solution, below 7.3 or above 7.4. Typically, the charged oxide is selected from the group consisting of silaceous oxides, titanium oxides, aluminum oxides, calcium oxides, zinc oxides, nickel oxides and iron oxides. In some embodiments, the composition further comprises a second oxide selected from the group consisting of calcium oxide, sodium oxide, magnesium oxide, zinc oxide, phosphorus oxide and alumina. In a typical embodiment of the invention, the charged oxide is silaceous oxide, the second oxide comprises calcium oxide and the ratio, by molar ratio, of silaceous oxide to calcium oxide is 0.25 to 15. Optionally, the composition further comprises phosphorous oxide. Unlike conventional silaceous oxide compositions, the composition of the invention can be free of sodium oxide. [0008] The charged oxide can be porous or non-porous. In some embodiments, the charged oxide comprises glass beads that are from about 10 nm to about 100 microns in diameter, typically from about 3 to about 10 microns in diameter. In some embodiments, the oxide is a layered clay such as the aluminosilicate Kaolin. In some embodiments, the charged oxide is porous, having pores of 2-100 nm diameter, typically 100-200 μm diameter. The greater the porosity, the greater the surface area. The internal surface can be between 1 and 1500 square meters per gram as determined by BET N 2 adsorption. While non-porous bioactive glass typically has a surface area around 20-30 square meters per gram, mesoporous bioactive glass is distinct because its surface area is greater than 200 square meters per gram. In a typical embodiment, the surface area is between 300 and 1000 square meters per gram. [0009] Additional components that can be included in a composition of the invention include a zeolite and/or an inorganic salt. Examples of an inorganic salt include, but are not limited to, a divalent ion selected from the group consisting of zinc, copper, magnesium, calcium and nickel, as well as the following: CaO, CaCl 2 , AgNO 3 , Ca(NO 3 ) 2 , Mg(NO 3 ) 2 , Zn(NO 3 ) 2 , NH 4 NO 3 , AgCl, Ag 2 O, zinc acetate, magnesium acetate, calcium citrate, zinc citrate, magnesium citrate, magnesium chloride, magnesium bromide, zinc chloride, zinc bromide, calcium bromide, calcium acetate and calcium phosphate. [0010] In some embodiments, the charged oxide is hydrated to between 0.1% and 25%, typically between 0.5% and 5% w/w. The composition of the invention can be prepared as a sol-gel. In some embodiments, the composition further comprises an ammonium phosphate buffer. [0011] The invention additionally provides a method of modulating hemostasis comprising contacting blood with a composition described herein. The modulating can comprise decreasing blood coagulation time, for which purpose the composition has an isoelectric point below 7.3. Examples of materials with an isoelectric point below 7.3 include, but are not limited to, silaceous oxides, titanium oxides and aluminosilicates. Alternatively, the modulating comprises increasing blood coagulation time and the composition has an isoelectric point above 7.4. Examples of materials with an isoelectric point above 7.4 include, but are not limited to, Al 2 O 3 and related aluminum oxides, calcium oxides, zinc oxides, nickel oxides, and magnetite and related iron oxides. [0012] Also provided is a method of preparing a hemostatic composition. The method comprises: co-assembling a bioactive glass sol with a structure-directing amount of a triblock copolymer of poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) to form a gel; and calcining the gel so produced at a temperature sufficiently high to remove the block copolymer and form mesopores; wherein the bioactive glass has an isoelectric point below the pH of blood. Similarly, the invention provides a method of preparing a passivated surface composition for minimizing coagulation upon contact of blood with the surface. The method comprises co-assembling a bioactive glass sol with a structure-directing amount of a triblock copolymer of poly(ethylene oxide)-poly (propylene oxide)-poly(ethylene oxide) to form a gel; and calcining the gel produced in step (a) at a temperature sufficiently high (typically 300-700° C.) to remove the block copolymer, form mesopores and create a highly hydroxylated surface, wherein the bioactive glass has an isoelectric point above the pH of blood. [0013] In addition, the invention provides a method of preparing a hemostatic composition. This method comprises passing a carrier gas through a solution comprising a bioactive glass sol to produce droplets; and spraying the droplets down a furnace. Examples of a carrier gas include, but are not limited to, air, nitrogen, oxygen, or natural gas. In some embodiments, such as for preparation of mesoporous materials, the solution further comprises a block copolymer. [0014] In another embodiment, the invention provides a method of preparing a hemostatic composition of micropores. The method comprises cooling a solution comprising silicic acid and calcium salts to below 0° C. to form a gel; and freeze-drying the gel to form micropores. Typically, the cooling step comprises cooling the solution to −70° C. to −200° C. In some embodiments, the solution further comprises a phosphorous oxide, typically in the form of a phosphate group. In another embodiment, the solution further comprises chitosan. The method can further comprise calcining the gel at 300 to 900° C. In a typical embodiment, the cooling comprises direction freezing. In some embodiments, the micropores produced by the method are 1 to 200 microns in diameter. [0015] The invention further provides a method of modulating hemostasis comprising contacting blood with a composition prepared by one of the methods described herein. In addition, the invention provides a medical device that has been coated with a composition of the invention, such as a composition having an isoelectric point above the pH of blood. [0016] Also provided is a method of promoting the formation of tissue comprising contacting the composition of the invention with a hydroxyapatite precursor solution. The tissue can comprise, for example, artificial bone, artificial skin, or a compound thereof. BRIEF DESCRIPTION OF THE DRAWINGS [0017] FIG. 1 is a plot of both clot detection time, R, (filled shapes) and rate of coagulation, α, (un-filled shapes) vs. BG Si:Ca. Data represents the mean of four trials. ▪ Porous BG;● Non-porous BG; ▾ Spherical BG; +No HA. [0018] FIG. 2 is a Thrombelastograph® plot of bioactive hemostatic agents. Inner Thromboelastograph plot on both plots is sheep blood without a HA added. [0019] FIG. 3 is a Thrombelastograph® plot of bioactive glass, QuikClot™, and sheep's blood alone. [0020] FIG. 4 is a thermogravimetric analysis and differential scanning calorimetry of the dehydration of porous and non-porous bioactive glass. 90 J/g (Non-porous Bioactive glass) and 450 J/g (Porous Bioactive glass). [0021] FIG. 5 is a Thrombelastograph® plot of mesoporous bioactive glass with varying SiO2:CaO ratios. BG 80 has a molar ratio of SiO2:CaO of 80:16 BG 60 has a molar ratio of SiO2:CaO of 60:16. [0022] FIG. 6 is a Thrombelastograph® plot of non-porous bioactive glass with varying SiO2:CaO ratios. BG NP 80 has a molar ratio of SiO2:CaO of 80:16. BG NP 70 has a molar ratio of SiO2:CaO of 70:16. BG NP 60 has a molar ratio of SiO2:CaO of 60:16. [0023] FIG. 7 is a thermogravimetric analysis and differential scanning calorimetry of the dehydration process for a hydrated mesoporous bioactive glass and a non-porous bioactive glass. [0024] FIG. 8 is a compilation of the heat of hydration and hydration capacity of bioactive glass. BG 80 has a molar ratio of SiO2:CaO of 80:16. BG 60 has a molar ratio of SiO2:CaO of 60:16. [0025] FIG. 9A shows a Thromboelastograph® plot of the hemostatic activity MBGM- 80 induced coagulation vs. blood w/o MBGM- 80 . [0026] FIG. 9B shows a plot of both clot detection time, R, (filled shapes) and rate of coagulation, α, (un-filled shapes) vs. amount of mesoporous bioactive microspheres. Data represents the mean of four trials. ▪ MBGM- 60 , ● MBGM- 80 , ▴ MBGM- 60 Non-porous, ▾ MBGM- 80 Non-porous, +Sheep Blood w/o MBGM. [0027] FIG. 10 shows BET adsorption-desorption isotherm of bioactive glass. [0028] FIG. 11 shows pore size distribution of mesoporous bioactive glass. [0029] FIG. 12 shows BET surface area and pore diameter calculations. [0030] FIG. 13 shows wide angle x-ray diffraction of bioactive glass substrates pre- and post-immersion in simulated body fluids for 1 hour. [0031] FIG. 14 is a Thrombelastograph® plot of oxides with an isoelectric point below the pH of blood. [0032] FIG. 15 is a Thrombelastograph® plot of oxides with a isoelectric point above the pH of blood. [0033] FIG. 16 shows R (min), onset of clot detection, versus the metal oxide's isoelectric point for low-surface area metal oxides. [0034] FIG. 17 shows α (°), rate of coagulation, versus the metal oxide's isoelectric point for low-surface area metal oxides. DETAILED DESCRIPTION OF THE INVENTION [0035] The invention is based on the discovery that oxide materials can be prepared to modulate hemostasis on the basis of surface change. This modulation enables the synthesis of materials that are: pro-coagulants; or, alternatively other materials that are anticoagulants. The latter are of importance with respect to the oxide coatings that form on metal medical implant devices. The methods of preparing oxide compositions of the invention avoid problems associated with longer setting times and also produce materials having better performance characteristics. The methods of the invention produce materials that offer superior compositional and structural homogeneity and higher surface area, which provide more effective materials. For example, one embodiment of the invention provides a rapid-setting, mesoporous, bioactive glass cement that exhibits excellent plasticity, superior bioactivity and is mechanically robust. In addition to modulation of hemostasis, the oxide compositions of the invention can be used for growth and repair of bone and other tissues as well as in drug delivery. [0036] In one embodiment of the invention, high surface area mesoporous bioactive glass has been prepared by a sol-gel template directed assembly. This material has the ability to conform and adhere to wounded tissue to promote blood clot formation. This specific material has a distinct morphological advantage over previous bioactive glass materials in that it can conform and adhere to any wound cavity geometry. When mixed with an ammonium phosphate buffer solution, a bioactive glass cement can be formulated that has a predictable set time and accelerates the deposition of new apatite layers when in contact with biological fluids. Mesoporous bioactive glass (MBG) cements are malleable before setting and retain their shape and mechanical strength without crumbling after setting. Furthermore, mesoporous bioactive glass has demonstrated a high osteoconductive property. This material can be formulated in a variety of compositions for applications as a rapid acting hemostatic agent, template for the growth of artificial bone, and the generation of tissue. Bioactive glass can be formulated for a variety of distinct wound healing scenarios and can elicit a predictable wound healing response, for both controlling the flow of blood as well as controlling the rate of apatite deposition, as a function of agents chemical composition and Si to Ca ratio. [0037] In addition to the synthesis of mesoporous bioactive glass, this invention provides a method by which materials can be selected based on their isoelectric point to induce a predictable hemostatic response. Under physiological conditions, the isoelectric point of an oxide will determine both the sign and magnitude of the initial surface charge density upon exposure to biological fluids. Oxides have been identified that will induce coagulation upon exposure to blood. Oxides have also been identified that will prevent or slow down the coagulation response of blood in contact with the surface of the oxide. A strategy to produce both rapid acting hemostatic agents and passivated medical device surfaces is described based on the selection criteria. [0000] Definitions [0038] All scientific and technical terms used in this application have meanings commonly used in the art unless otherwise specified. As used in this application, the following words or phrases have the meanings specified. [0039] As used herein, a “hemostatically effective amount” means an amount sufficient to initiate detectable blood clotting (R) within 2 minutes, and/or achieve a rate of clotting (α) of 50° or greater, and/or achieve a clot strength (MA) of ≧50, as determined by Thromboelastograph® measurements. Assays for determining hemostatic effectiveness are known in the art, and described in the Examples below. [0040] As used herein, a “thromboelastograph® assay refers to measurements typically taken using about 5-30 mg of material mixed with 340 microliters of citrate stabilized blood. Calcium ions are re-supplied to the citrate stabilized blood prior to measurements to replace the calcium ions chelated by citrate. [0041] As used herein, “isoelectric point” refers to the pH at which the zeta-potential equals zero in an aqueous electrolyte such as 2 mM CaCl 2 . The zeta potential is the surface charge density of a metal oxide in aqueous suspension, measured as a function of pH by the electrophoretic method using the Smoluchowski equation (Cocera, M. et al., Langmuir 1999, 15, 2230-2233). Unless specifically indicated otherwise, the zeta potential of the metal oxide is measured in a CaCl 2 electrolyte that mimics the Ca 2+ concentration in blood. [0042] As used herein, “homogeneous” means an absence of phase separation (e.g., separation of a silicate phase and a phosphate phase); the materials are not phase segregated when examined by energy-dispersive x-ray analysis (EDX) using scanning electron microscopy (SEM) with a resolution limit of 0.5 microns. A composition is homogeneous if it consists of a uniform distribution or dispersion of components. [0043] As used herein, a “bioactive glass sol” means a colloidal suspension containing silica precursors and calcium salts that can be gelled to form bioactive glass solid, wherein the solvent can be water, ethanol or other substance that can dissolve silica precursors and calcium species. [0044] As used herein, “a” or “an” means at least one, unless clearly indicated otherwise. [0000] Bioactive Glass (BG) [0045] For the sol-gel-derived BGs to exhibit in vitro bioactive behavior, it has been shown that both the chemical composition and textural properties (pore size and volume) are important. Melt-derived glasses show a direct dependence on composition with bioactivity. Increasing the specific surface area and pore volume of BGs will greatly accelerate the kinetic deposition process of hydroapatite and therefore enhance the bone-forming bioactivity of BGs. Several strategies have been developed to obtain high specific surface area materials and engineer pore structure of the BGs, including using soluble inorganic salt, colloidal spheres or block copolymers as pore-forming agents. The high surface area mesoporous bioactive glass described herein has a unique morphology with advantages over these methods including higher surface area and ease of functionalization of the final material. This functionalization includes, but is not limited to, the surface immobilization and the controlled release of biologically relevant molecules. Molecules such as phospholipids, fibrin, collagen, clotting zymogens, heat shock proteins, antibacterial peptides, and silver, magnesium, calcium, sodium, zinc, chloride, and phosphate ions can be controllably released to effect an optimal bio-response. [0046] The porous bioactive glass material can be described by the general formula (SiO 2 —CaO—P 2 O 5 —MO (M=Na, Mg, etc.). BET analysis has shown that the bioactive glass of the invention has a surface area far greater than the 5 square meters per gram (m 2 /g) observed in prior art materials, and typically in the range of more than 100 m 2 /g, often more than 200 m 2 /g. In one embodiment, the bioactive glass of the invention has a surface area of at least about 300 m 2 /g. Surface areas of 500-1000 m 2 /g can be attained. The surface area is influenced by the polymer used in synthesis of the bioactive glass. A surface area of about 300 m 2 /g has been attained with bioactive glass prepared from P123, while low molecular weight polymers, such as L43, can produce much higher surface area (in the range of 900 m 2 /g). The high surface area provides for optimal pore volume. [0000] Hemostatic Activity of Bioactive Glass [0047] Disclosed herein is a new and specific application of bioactive glass related to rapid acting hemostatic agents for the treatment of traumatic injuries. The traumatic wound healing scenario is distinct from prior medical applications for bioactive glass-like materials. The term “bioactive glass” has been loosely applied to many companies of calcium oxide, silicon dioxide, phosphorous oxide and other metal oxides, the combination of which is able to promote the growth of bone and tissue. [0048] The invention described in U.S. provisional patent application No. 60/668,022, filed Apr. 4, 2005, provides a calcium loaded zeolite linde type A that is ion exchanged with aqueous solutions of alkali, alkaline earth, and transition metal cations to specific ion formulations. This ion exchanged zeolite can be mixed with neutral inorganic salts like calcium chloride, aluminum sulfate, and silver nitrate and dehydrated to remove water. The dehydrated inorganic materials are sealed in mylar foil bags to prevent rehydration until required during medical application. At the time of medical application, the mylar bag can be opened and the inorganic contents poured into the traumatically injured site. [0049] The present invention provides the bioactive glass in a gel, liquid, cement, paste or powder form, which allows for greater ease of use and better conformation to a desired area to be treated. By providing the material in gel (or cement) form, for example, it can be applied to a greater variety of surfaces, increasing its availability for use in numerous contexts, including application to medical devices and drug delivery. [0050] Porous bioactive glass materials have been designed to treat traumatically injured tissue by inducing hemostasis through contact activation and release of coagulation co-factors. In addition, the compositions of the present invention provide a uniform pore size that further optimizes its use for regulation of hemostasis. [0051] The hemostatic activity of bioactive glass is dependent on the material's chemical composition. For the range of chemically distinct bioactive glass agents studied (Si:Ca:P atomic _ratio 60:34:4 to 90:6:4), the onset time for contact-activated coagulation, rate of coagulation of post-initiation, and ultimate clot strength was found to be dependent on the material's Si:Ca ratio, porosity, and heat of hydration. The onset time for contact-activated coagulation was found to decrease in an increasing Si:Ca ratio. The rate of coagulation post-initiation was found to increase with an increasing Si:Ca ratio. Porous bioactive glass was found to have a greater procoagulation tendency than non-porous bioactive glass. [0000] Bone-generating Activity of Bioactive Glass [0052] The bone-generating activity of bioactive glass is dependent on the material's chemical composition. For the range of chemically distinct bioactive glass agents studied, (Si:Ca:P atomic _ratio 60:36:4 to 90:6:4) the deposition rate of hydroxyapatite deposition in biological fluids is related to the material's Si:Ca ratio and particle size and shape. The rate of deposition of hydroxyapatite was observed to be faster for bioactive glass samples with a lower Si:Ca ratio (e.g., BG60:36:4 faster than BG80:16:4). [0053] The high osteoconductive properties of this unique formulation of bioactive glass is a result of the presence of a large number of surface hydroxyl groups (Si—OH) that provide nucleation sites for apatite-like layer growth. The sol-gel technique developed in our laboratory allows us to optimize these nucleation sites for a tailored bio-response, and ultimately an improved generation of hydroxyapatite. [0000] The Isoelectric Point Material Property as a Predictor of Hemostatic Activity [0054] The isoelectric point of a material is a critical material parameter that can be utilized to select oxides that can either promote or prevent the induction of hemostasis. Rapid acting hemostatic agents and passivated medical devices are applications intended for this material. The present inventors have discovered that the oxide's initial surface charge, driven by the isoelectric point of the material relative to the pH of the immersing biological medium, is the key factor in controlling hemostatic efficacy of the composition. [0055] The onset time for contact-activated coagulation, rate of coagulation post-initiation, and ultimate clot strength are found to be dependent on the initial surface charge density of the metal oxide when exposed to blood, which is related to the oxide's acid-base nature and is quantitatively described by its isoelectric point. We found, that for polar metal-oxide substrates, the time to initiate contact-activated coagulation increases with the increase in the metal oxide's isoelectric point. [0056] Blood is usually the first fluid an implanted foreign body encounters, and thus the thrombotic complications which arise from metallic implants (chronic inflammatory response), and inorganic-based estracorporeal circulating devices parts, arterial stents, and catheters is related to the chemistry that occurs during the initial exposure of blood to a foreign oxide surface. Although the activating inorganic surface will become contaminated with biological products over time (e.g. massive attack complex, fibrin 12 ), the initial surface charge density of a metal oxide surface will affect the selective adhesion of oppositely charged molecules and biological media (e.g. cells and larger proteins) immediately upon contact with blood. We observed that both the sign and magnitude of the metal oxide's surface-charge density affects blood coagulation metrics, including the onset time, rate of clot formation, and viscoelastic strength of contact-activated blood clots, and that an oxide's isoelectric point can be used to predict its in vitro hemostatic activity. [0057] Negatively-charged surfaces are known to initiate the intrinsic pathway of the blood coagulation cascade, a network of feedback-dependent reactions that when activated results in a blood clot. The activation of this process by a foreign body is referred to as contact activation of coagulation. The same network of coagulation reactions also can be activated via the entrinsic pathway, which occurs when a breach in the endothelium allows the exposure of platelets to tissue factor bearing cells. [0058] Because of the electronegativity difference between oxygen atoms and the metallic atoms they are covalently bonded to, metal oxides are inherently polar surfaces. Their surface chemistry is all the more complicated due to the presence of “dangling” terminal hydroxyl groups on unsaturated metal sites and related defect sites. The surface charge of metal oxides is known to be pH dependent and is thought to result from either the amphoteric dissociation of surface MOH groups or the adsorption of metal hydroxo complexes derived from the hydrolysis product of material dissolved from the metal oxide. There exists a unique pH for each oxide above which the material is negatively charged and below which the material is positively charged. The pH at which the sum total of negative and positive surface charges equals zero, Σ(z-n) M z (OH) n z-n =0, is called the isoelectric point. [0059] We have observed a variable contact-activated coagulation response from metal oxides with distinct isoelectric points, all of which are inherently polar substrates, and which requires that we refine our understanding of the traditional definition of hemocompatibility based on surface energetics. We have found that acidic oxides are prothrombotic while basic oxide are antithrombotic. The relative difference between the metal-oxide's isoelectric point and the pH of blood determines the initial surface-charge density of the substrate when exposed to blood. This material parameter has been shown to affect the onset time for coagulation, rate of coagulation post-initiation, and ultimate clot strength. [0000] Thromboelastograph Assay [0060] Thromboelastograph®. The in vitro hemostatic activity of metal-oxide hemostatic agents was evaluated as previously described using a THromboelastograph®, a clinical instrument that monitors the change in viscoelasticity of blood as a function of time. Briefly, 340 μL of 4% v/v citrate-stabilized sheep blood (Quad Five of Ryegate, Mont.) was introduced into the sample cup of a Thromboelastograph®, Haemoscope model 5000, along with 20 μL of 0.2M CaCl 2 (aq) and 5-20 mg of a tested metal-oxide in a powder morphology. The 20 μL of 0.2 M CaCl 2 (aq) was added to the stabilized blood to replenish the Ca 2+ ions chelated by citrate, which was added to prevent coagulation of stored blood. Blood was stored at 8° C. prior to use. [0061] The thromboelastograph® sample cup is rotated ±5° about a vertical torsion wire suspended in the middle of the cup. As the hardening blood clot tugs on the torsion wire, the change in viscoelectric clot strength is monitored as a function of time. The time until the bimodal symmetric viscoelasticity curve's amplitude is 2 mm is referred to as R (minutes), and represents the initial detection of clot formation. The angle between the tangent to the curve and the horizontal is referred to as α (°), and is related to the rate of coagulation. The maximum amplitude of the curves is referred to as MA (mm) and represents the maximum clot strength. Thromboelastograph® clotting parameters reported represented the mean of four reproducible trials. A summary of the hemostatic properties of metal-oxides with variable isoelectric points is described in Table 1. TABLE 1 Summary of Metal-Oxide Contact-Activated Coagulation Low-surface-area High-surface-area Clotting Metric metal oxides metal oxides Onset of Coagulation onset time Coagulation onset coagulation; increased or of equal time for positively R (min) value compared to blood charged surface Initially alone for positively similar to blood Positively charged surface, and alone Charged Metal slowest for the most Oxide positive surface Initially Coagulation onset time Coagulation onset Negatively reduced for negatively time reduced for Charged Metal charged surfaces, and negatively charged Oxide fastest for most nega- surfaces tive substrate Rate of Positively-charged Positively-charged coagulation surfaces decelerate surfaces decelerate post-initiation; the rate of coagulation the rate of α (°) coagulation Initially Positively Charged Metal Oxide Initially Negatively-charged Negatively-charged Negatively surfaces accelerate surfaces accelerate Charged Metal the rate of coagulation the rate of coagula- Oxide tion in the presence of sufficient Ca2+ ions Isoelectric Point Isoelectric Point Clotting Metric Below the pH of Blood Above the pH of Blood Onset of Coagulation onset time Coagulation onset time coagulation; reduced for negatively increased or of equal R (min) charged surfaces, and value compared to fastest for most blood alone for negative substrate positively charged surface, and slowest for the most positive surface Rate of Negatively-charged Positively-charged coagulation surfaces accelerate surfaces decelerate post-initiation; the rate of coagulation the rate of coagulation α (°) Ultimate clot Most negative oxide Induced blood clots strength (MA) resulted in strongest are less than or blood clots and least equal in strength to negative oxide resulted naturally formed in weakest blood clot blood clots Methods [0062] The invention provides a method of producing a composition for modulating hemostasis, and also a method of modulating hemostasis comprising contacting blood with a composition of the invention. Compositions that modulate hemostasis can be prepared by the methods described in the Examples below, including aerosol synthesis and use of sol-gel chemistry. Sol-gel chemistry can be used to produce bioactive glass. By spraying the sol-gel solution down a hot furnace (e.g., 400° C.), spherical bioactive glass particles are produced. These bioactive glass particles can be as small as 10-50 nm in diameter, or smaller, or as large as about 100 μm or larger. In one embodiment, the particles are 50-200 nm in diameter. [0063] Typically, the method of producing a composition of the invention involves starting from a bioglass sol, wherein the solvent is ethanol (or another solvent that can dissolve precursors and has a low boiling point). A block copolymer can be used as an additive to provide a pore-forming agent. [0064] In some embodiments, such as the freezing method, the ideal solvent is water rather than ethanol because the melting point of ethanol is very low. The difference in solvent typically calls for some difference in the method. For example, most PEO—PPO—PEO block copolymers cannot dissolve in water. Second, chitosan can be incorporated into the system because it doesn't dissolve in the ethanol, and chitosan plays an important role in modulating blood coagulation. In addition, the silica and phosphorous precursors are different from those in an ethanol-based method and phosphorous oxide is not required in the starting sol, as would be the typical case when starting with a bioglass sol. [0065] In some embodiments, the method of modulating hemostasis comprises decreasing blood coagulation time. In one embodiment, the time to initiate detectable coagulation (R), as measured by thromboelastograph®, is less than 2 minutes, and can be less than 1.8 minutes. In another embodiment, the rate of coagulation (α), is measured by thromboelastograph®, is more than 50°. Coagulation rates of more than 55°, and of more than 65° have been achieved. In a further embodiment, the coagulation results in blood coagulation time. Increased coagulation time is desirable, for example, when clotting poses a health risk to the subject. [0000] Applications of the Invention [0066] Oxides with an isoelectric point below the pH of blood can be formulated for action to induce blood clot formation faster than blood would naturally do in the absence of an oxide-contact activator. The materials can be applied both externally and internally as agents to induce hemostasis and reduce the flow of blood in a particular area of the body. [0067] Oxides with an isoelectric point above the pH of blood can be formulated to induce blood clot formation slower than blood would naturally do in the absence of an oxide-contact activator, and therefore would be suitable as passivated surfaces for medical devices. Thus, the invention provides a medical device and methods of coating a medical device with a composition of the invention. Coatings can be prepared from a composition in powder form or using sol-gel chemistry, using conventional methods known in the art. In one embodiment, the coating reduces coagulation of blood in contact with the device. The medical devices include, but are not limited to, arterial and verial stents, catheters, shunts, and any medical machinery that will contact blood during invasive medical procedures. [0068] Oxides with an isoelectric poin above the pH of blood can be formulated for devices that require a positively charged surface to interface with biological tissue and fluids. [0069] Oxides with an isoelectric point below the pH of blood can be formulated for devices that require a negatively charged surface to interface with biological tissue and fluids. [0070] When mixed with an ammonium phosphate buffer solution, a bioactive glass cement can be prepared with a controllable set time, Bioactive glass, and particularly, bioactive glass cement, can be prepared with a flexible morphology that allows for conformation and adhesion to any wound geometry. The bioactive glass cement can be molded in a variety of shapes that retain their mechanical integrity post-setting. The bioactive glass cements can accelerate the deposition of an apatite layer compared to the bioactive glass agent alone. [0071] Mesoporous bioactive glass can be formulated as a rapid acting hemostatic agent. This material can predictably warm injured tissue to promote wound healing. [0072] Mesoporous bioactive glass can be formulated to promote the formation of artificial bone. This same material can be used to generate tissue including, but not limited to, artificial skin and structural elements such as fibrin and collagen. [0073] The internal porous architecture can be loaded with biologically relevant molecules and cofactors for controlled release during wound healing and body repair. These biologically relevant molecules and cofactors include, but are not limited to, phospholipids, blood coagulation factors, fibrin, collagen, blood clotting symogens, silver ions, magnesium ions, and calcium ions. [0074] The internal porous architecture can be loaded with antibacterial peptides and silver ions for a controlled release of antibacterial agents. [0075] Non-porous bioactive glass can be formulated as a rapid acting hemostatic agent. This material can predictably warm injured tissue to promote wound healing. [0076] Non-porous bioactive glass can be formulated to promote the formulation of artificial bone. This same material can be used to generate tissue including, but not limited tot, artificial skin and structural elements such as fibrin and collagen. [0077] The hemostatic activity of bioactive glass can be controlled and optimized for a variety of wound healing scenarios by manipulating the ratio of Si to Ca in the chemical composition of both porous and non-porous bioactive glass. The bone-generating activity of bioactive glass can be controlled and optimized for a variety of wound healing scenarios by manipulating the ratio of Si to Ca in the chemical composition of both porous and non-porous bioactive glass. EXAMPLES [0078] The following examples are presented to illustrate the present invention and to assist one of ordinary skill in making and using the same. The examples are not intended in any way to otherwise limit the scope of the invention. Example 1 Hemostatic Activity of Bioactive Glass [0079] The time clot unit detection, R, decreases for increasing Si:Ca ratios in BG ( FIG. 1, 2 ). R is reduced by a factor of 2 when the Si:Ca ratio is doubled over the range studied. [0080] BG can perform the dual role of providing surface area for thrombosis and supplying Ca 2+ ions; hence there will be an optimum ratio of SiO 2 to Ca 2+ ions, which are co-factors throughout the clotting cascade, for the fastest hemostatic response. The BG-induced coagulation rate, α, increases with increasing Si:Ca ratios and maximizes for the same Si:Ca ratio as the minimum R time (Si:Ca(R min x max )˜2.5). All blood clots induced by BGs resulted in stronger than natural clots (MA BC ≧62 and MA Natural =58 dyn/cm 2 ). Example 2 Formulation of Mesoporous Bioactive Glass [0081] The unique formulation of high surface area mesoporous bioactive glass that we have prepared has the ability to rapidly induce a blood clot when exposed to blood. In fact, the formulation we have prepared has a faster clotting time and results in a stronger clot than QuikClot™, the leading inorganic hemostatic agent currently available (see FIG. 3 ). Both the porous and non-porous formulations of bioactive glass possess this ability to rapidly promote blood coagulation. Because the porous and non-porous formulation of bioactive glass can be hydrated to different degrees, and consequently will deliver different amounts of heat upon hydration during medical application to a wound site, we can further tailor the rate of blood coagulation. Combinations of porous and non-porous bioactive glass can be formulated to the desired specifications of hydration and delivery of heat (see FIG. 4 ). Example 3 Mesoporous Bioactive Glass with Varying Ratios of SiO2:CaO [0082] This example shows that one make the bioactive glass with varying ratios of SiO2:CaO. At higher SiO2:CaO ratios (more silica), the material tends to clot blood faster. This is illustrated in both FIGS. 5 and 6 . As the amount of SiO2 relative to the amount of CaO is reduced, the kinetics of clot formulation are much slower. The difference in clotting kinetics between two bioactive glass samples with different SiO2:CaO is more pronounced with the non-porous samples. The mesoporous bioactive glass is a faster clotting agent than the non-porous samples, but the difference between samples is greater within the non-porous samples. [0083] This example also shows that one can use combinations of porous and non-porous bioactive glass, as well as composites with multiple bioactive glasses of different SiO2:CaO ratios, to achieve any desired hydration capacity and heating response when in contact with blood (see FIGS. 7 and 8 ). Example 4 Spherical Bioactive Glass [0084] Spherical Bioactive glass is produced by an aerosol assisted method and with the same sol-gel precursor solution employed for bioactive glass previously described. Spherical bioactive glass accelerates the formation of a contact-activated clot. The activity of bioactive glass is dependent on the relative amount of contact activating agent to the surrounding blood volume ( FIG. 9 ). Example 5 Host-Guest Composites [0085] The porous architecture of mesoporous bioactive glass is ideal for the controlled release of biomolecules. These molecules can be immobilized on the oxide surface of pores. Each of these formulations wil have a unique release profile with regard to concentration and rate of release. The combination of porous bioactive glass and biomolecules is referred to as a host-guest composite. [0086] Host-guest composites can also be prepared to release ions including, but not limited to, silver, magnesium and calcium ions. Silver ions have been shown to be antibacterial at parts per billion concentration in biological fluids. Magnesium and calcium ions are essential cofactors during the coagulation of blood. Certain formulations of porous bioactive glass can also sequester magnesium and calcium from blood to delay the coagulation in response. [0000] Synthesis [0087] Mesoporous bioactive glasses (MBGs were synthesized by co-assembly of a BG sol with a triblock copolymer poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) as the structure-directing agent through an evaporation-induced self-assembly (EISA) process. The dried gel was calcined at high temperature to remove the block copolymer and form mesopores. The final MBGs were ground into powders. The as-calcined MBGs have more accessible mesopore surface area and ordered pore structure. In vitro study showed a greater bone-forming bioactivity than conventional sol-gel derived BGs by fast formation of an amorphous bioactive HA layer. Example 6 Bioactive Glass Cements [0088] Bioactive glass cements were prepared by mixing bioactive glass powders with an ammonium phosphate buffer solution. The liquid component of MBGCs, an ammonium phosphate buffer solution, was prepared by dissolving 60.1 g (NH 4 ) 2 HPO 4 and 5.0 g NH 4 H 2 PO 4 in 100 mL water. The pH of the resulting solution was ˜7.3. MBGC cements were made by mixing the solid and liquid components at the ratio of 1 g to 1 ml. The cements were kept in the ambient environment to set. Before setting fully, they were soft enough to be kneaded or molded. Structural characterizations were typically carried out at ˜1 h after the mixing of the solid and liquid components of MBG, and no structural changes were observed after 1 h after mixing. [0089] The assessment of the in vitro bioactivity of bioactive glass powders and cements was carried out in SBF at 37° C. SBF contained 142.0 mM Na + , 5.0 mM K + , 1.5 mM Mg 2+ , 2.5 mM Ca 2+ , 147.8 mM Cl, 4.2 mM HCO 3 , 1.0 mM HPO 4 2 , and 0.5 mM SO 4 2 . Its chemical composition is similar to that of human plasma. The solution had a pH of 7.3-7.4 and was kept at 37° C. before use. Example 7 Surface Area Measurements of Mesoporous Bioactive Glass [0090] This example presents data on the surface area measurements that have been made of the mesoporous bioactive glass of the invention. In FIG. 10 , the adsorption-desorption isotherm is presented. The lack of hysteresis suggests a channel-like structure without internal cages. This adsorption-desorption isotherm can be used to calculate the pore size distribution of the mesoporous bioactive glass based on the BJH model. A plot of the pore size distribution is illustrated in FIG. 11 . [0091] The calculated surface area of mesoporous bioactive glass is displayed in FIG. 12 . Bioactive glass can be formulated with a surface area ranging from 300 m 2 /g to 1000 m 2 /g. The sample that was used for the measurements described in this example had a surface area of 960 m 2 /g. The internal pore diameter was calculated to be 3.1 nm based on the BJH model and 2.5 nm based on the BET model. Example 8 Bone-Generating Activity of Bioactive Glass [0092] The assessment of the in vitro bioactivity of bioactive glass powders and cements was carried out in simulated body fluids (SBF) at 37° C. SBF contained 142.0 mM Na + 5.0 mM K + , 1.5 mM Mg 2+ , 2.5 mM Ca 2+ , 147.8 mM Cl − , 4.2 mM HCO 3 , 1.0 mM HPO 4 3 , and 0.5 mM SO 4 2 . Its chemical composition is similar to that of human plasma. The solution had a pH of 7.3-7.4 and was kept at 37° C. before use. The in vitro assessment of in vivo bone-generating bioactivity is typically conducted by monitoring the formation of hydroxyapatite on the surface of bioactive glass after immersion in SBF. After mixing the bioactive glass powder with the ammonium phosphate buffer solution, weak x-ray diffraction peaks at 20=26° (002) and 32° (211) corresponding to hydroxyapatite are observed. The broad peak at 2θ=23° is due to the amorphous nature of the bioactive glass walls ( FIG. 13 ). The average hydroxyapatite crystal size nucleated after immersing BG60:36:4 in simulated body fluids for one day is 37 nm. The average hydroxyapatite crystal size nucleated after immersing BG80:16:4 in simulated body fluids for one day is 32 nm. Faster rates of hydroxyapatite were observed with BG60:36:4 compared to BG80:16:4. Example 9 Isoelectric Point, Fast Acting, Clotting Agents, and Passivated Medical Device Surfaces [0093] As described in U.S. provisional patent application No. 60/668,022, filed Apr. 4, 2005, we have identified four critical materials parameters that can be used to predict the hemostatic response for exposing a given oxide to blood. We have shown that blood coagulation can be induced rapidly through the dehydration of blood, application of an appropriate amount of heat, and by delivering ions, like calcium, that are cofactors in the blood coagulation network. Oxides with a surface charge will also induce a coagulation response. More specifically, the isoelectric point is the underlying principle effecting the surface charge induced contact activation coagulation response. [0094] Every oxide material will possess an initial surface charge that is a function of both the isoelectric point of the material and the pH conditions of the immersing solution (see FIG. 14 ). By observing the rate of coagulation of blood upon exposure to a variety of inorganic oxides, we have observed that those materials with an isoelectric point below the pH of blood accelerate the coagulation response (see FIG. 14 ). Those materials with an isoelectric point above the pH of blood are observed to decelerate the coagulation response (see FIG. 15 ). [0095] Designing rapid acting hemostatic agents requires an optimization of the four material parameters already identified: isoelectric point, hydration capacity, thermal application (heat), and control of the local electrolyte conditions. Similarly, designing passivated medical device surfaces for contact with blood requires a related, albeit opposite, optimization of these material parameters compared to a fast acting clotting agent. By selecting oxides of varying isoelectric points, it is possible to modulate the blood coagulation response from spontaneous coagulation to inhibition of coagulation. This control over the blood response is unique to inorganic oxides and offers major advantages over current organic based hemostatic technology. This relationship between isoelectric point and coagulation provides for the design of new bioactive glass compositions tailored to desired objectives in the regulation of hemostasis. Example 10 Isoelectric Point and Low-surface-area Metal Oxides [0096] It is well accepted that negatively charged surfaces activate the intrinsic pathway of the blood clotting cascade. The SiO 2 glass beads, which have the lowest isoelectric point (IEP=2.1) of all the low-surface-area oxides analyzed, initiated the formation of a detectable blood clot on average 2.9 min after exposure to sheep blood. Because this material has the lowest isoelectric point, under physiological conditions (pH=7.3-7.4), SiO 2 substrates will initially possess the greatest negative surface-charge density compared to the other oxides tested. The time until clot detection increases with the increasing isoelectric point of the low-surface-area materials studied ( FIG. 16 ). NiO has the isoelectric point that is closest to the pH of blood, and the average clot time induced by NiO is nearly indistinguishable from that of blood in its absence (R NiO =11 min and R Bloodstream =10.9 min). Zno has the highest isoelectric point of the materials studied (IEP=9.5) and was observed to actually delay the time until blood clot detection by about 1.5 min compared to sheep blood alone. [0097] The fastest rate of coagulation, α (°), for the low-surface-area metal oxides, was observed with the SiO 2 glass beads (α=75.2°, IEP=2.1), which initially posses the most negative surface in blood compared to the other low-surface-area metal oxides studied ( FIG. 17 ). The slowest rate of coagulation was observed when ZnO was introduced to sheep blood (α Blood =50.2°; α ZnO =30.4°). ZnO possesses the maximum positive surface charge when immersed in blood. All of the oxides with an isoelectric point above the pH of blood were observed to decelerate the rate of coagulation compared to blood alone, and in particular, NiO, which has the closest isoelectric point to the pH of blood but will be positively charged after immediately contacting blood, was observed to reduce the rate of coagulation. [0098] From the foregoing it will be appreciated that, although specific embodiments of the invention have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention.

The invention provides a homogeneous composition comprising a hemostatically effective amount of a charged oxide, wherein the composition has an isoelectric point, as measured in calcium chloride, below 7.3 or above 7.4. Typically, the charged oxide is selected from the group consisting of silaceous oxides, titanium oxides, aluminum oxides, calcium oxides, zinc oxides, nickel oxides and iron oxides. In some embodiments, the composition further comprises a second oxide selected from the group consisting of calcium oxide, sodium oxide, magnesium oxide, zinc oxide, phosphorus oxide and alumina. In a typical embodiment of the invention, the charged oxide is silaceous oxide, the second oxide comprises calcium oxide and the ratio, by molar ratio, of silaceous oxide to calcium oxide is 0.25 to 15. Optionally, the composition further comprises phosphorous oxide. Also described are methods of making and using such compositions.

PRIORITY [0001] This application claims the benefit of the provisional application having Ser. No. 60/707,207 filed on Aug. 10, 2005, which is hereby incorporated in its entirety by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to writing instruments and more particularly to a writing instrument that has a cosmetic compartment and mirror. [0004] 2. Description of the Prior Art [0005] Cosmetic applicators have been known in the prior art for some time. These applicators tend to be large, bulky and heavy. The size and weight of these applicators is directly related to the need for room for the cosmetic and means of application. [0006] In U.S. Pat. No. 2,057,085, to G. J. Danco, a cosmetic applicator for lipstick is shown comprising an outer protective casing that is adapted to serve as a handle for applying the cosmetic to the user. The disclosed device includes flexible applicator band rotatably disposed on a complicated roller assembly. The user rotates the applicator band passed the cosmetic disposed in an interior of the housing, thereby picking up the cosmetic for application on the user. The disadvantage of the present reference is that it is complicated, difficult and time consuming to use. Additionally, the device is limited to the application of the cosmetic contained in the housing. [0007] There have also been devices developed to remove a cosmetic or make-up from a user. In U.S. Pat. No. 6,148,828, to Bourassa, a device is disclosed comprising a casing having a wiping tip protruding from one of its ends. Similar to the device to Danco above, a slidable ribbon of wiping material is disposed in the casing. The Bourassa device includes a storage compartment (an interior of the casing) for holding unused wiping material until it is advanced over the wiping tip, used and eventually feed into a refuse compartment. A disadvantage of the present device is that it includes a complicated advancement mechanism to advance the wiping material from the storage compartment to the refuse compartment. Additionally, the device is limited to the removal of a cosmetic or make-up material. [0008] What is needed is a device that provides uncomplicated access to and/or application of a cosmetic to a user. What is additionally needed is a device that can be utilized for something other than the storage or application of a cosmetic. SUMMARY OF THE INVENTION [0009] The invention is a writing instrument having cosmetic compartment and/or mirror disposed to a housing or barrel that can be griped by a user during use. The housing can contain a writing implement such as a pen cartridge or a make-up applicator that can be used with the cosmetic compartment to apply a cosmetic to a user. [0010] A wipe material can be removably stored in an interior of the housing for selective removal by a user through a slot or slit extending through and along at least a portion of the length of the housing. The wipe material can be saturated with chemical to aid in the removal of the cosmetic. In another embodiment, the wipe material can be impregnated with a scent that would be pleasant to the user. The scent can be a perfume that the user wipes upon themselves at any time of the user's choosing. [0011] A nose cap can be removably coupled to an end of the housing to secure the ink cartridge for writing. The nose is also adapted to retain the wipe material in the interior of the housing. In one example embodiment, the nose cap can have a shape, size, or configuration to allow it to be used as the applicator for the cosmetic contained within the cosmetic compartment. [0012] A nose cap cover can be removably coupled to and telescopically extend over the nose cap to provide a means of protecting the nose cap. The nose cap cover can have an attachment means formed, coupled and the like thereto to permit convenient transportation of the device. [0013] An end cap can be coupled to an end of the housing opposite the nose cap. The end cap is utilized to secure a free end of the ink cartridge in the housing. In the example embodiment having a wiping material, the end cap can be utilized to retain the wiping material in the interior of the housing. [0014] In one example embodiment of the invention, the cosmetic compartment is disposed to the end cap during transportation and/or while the device is being used as a writing instrument. An inner cover can be hingedly coupled proximate to an opening of the cosmetic compartment to define an interior for retaining the cosmetic. [0015] A mirror cap or reflective end cover can be disposed to an end of the cosmetic compartment to allow a user to observe the application of the cosmetic. [0016] An object of the invention is to provide a writing instrument having a cosmetic compartment that is easily manufactured and used. [0017] Another objection of the invention is to provide a cosmetic compartment containing that is visually integrated with the housing of the writing instrument. [0018] The above summary of the invention is not intended to describe each illustrated embodiment or every implementation of the invention. The figures in the detailed description that follow more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS [0019] 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: [0020] FIG. 1 is an exploded view of a writing instrument and cosmetic compact according to an example embodiment of the present invention. [0021] FIG. 2A is a perspective view of a nose cap according to an example embodiment of the present invention. [0022] FIG. 2B is a cross section view along line 1 - 1 of the nose cap of FIG. 2A . [0023] FIG. 2C is an end view of the nose cap of FIG. 2A . [0024] FIG. 2D is a partial perspective view of FIG. 2C . [0025] FIG. 3A is a cross sectional view of a nose cap cover of FIG. 1 showing an interior thereof. [0026] FIG. 3B is an end view of the nose cap cover of FIG. 3A showing an opening extending therethrough. [0027] FIG. 3C is cross section view of the nose cap cover of FIGS. 3A and 3B illustrating a cosmetic applicator assembly in an extended position. [0028] FIG. 3D is a cross section view of the nose cap cover of FIGS. 3A and 313 illustrating a cosmetic applicator assembly in a retracted position. [0029] FIG. 4A is a side view of a coupling member for receiving a tether or the like for hanging the writing instrument and cosmetic compact about a user's neck. [0030] FIG. 4B is a perspective view of the coupling member of FIG. 4A . [0031] FIG. 5A is an exploded perspective view of an end cap assembly comprising an outer end cap and an inner end cap according to an example embodiment of the present invention. [0032] FIG. 5B is a cross section view of the outer end cap of FIG. 5A . [0033] FIG. 5C is an end view of the outer end cap of FIG. 5A . [0034] FIG. 5D is a cross section of the inner end cap of FIG. 5A . [0035] FIG. 5E is an end view of the inner end cap of FIG. 5A . [0036] FIG. 6A is an enlarged view of an end of the outer end cap showing a coupling assembly. [0037] FIG. 6B is a top view of the coupling assembly of FIG. 6A . [0038] FIG. 7A is a perspective view of a reflective member and cosmetic compact according to an example embodiment of the invention. [0039] FIG. 7B is a side view of the cosmetic compact of FIG. 7A . [0040] FIG. 7C is an end view of the cosmetic compact of FIG. 7A . [0041] FIG. 7D is a side view of the reflective member of FIG. 7A . [0042] FIG. 7E is an end view of the reflective member of FIG. 7A . [0043] The preceding description of the drawings is provided for example purposes only and should not be considered limiting. The following detailed description is provided for more detailed examples of the present invention. Other embodiments not disclosed or directly discussed are also considered to be within the scope and spirit of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT [0044] Referring to FIGS. 1-7E , a writing instrument and cosmetic compact is indicated by the number 100 . Writing instrument and cosmetic compact 100 includes a housing, barrel, or pen tube 110 having an open first end 112 and an open second end 114 in registration with each other. [0045] Referring to FIG. 1 , in a preferred embodiment, housing 110 is manufactured from a polymer such as polypropylene, polyethylene and the like. Housing 110 can be manufactured with any color, design or lettering printed on its outer surface for advertising of a particular trademark, logo, or brand. This is of particular importance if the writing instrument and cosmetic compact 110 is utilized as a marketing tool since vivid colors, designs and lettering typically attract a user's eyes and others toward the writing instrument. [0046] To ensure that housing 110 is comfortable to use it may have a generally cylindrical shape. However, housing 110 may have any cross sectional shape such as, for example triangular, square, oval, and the like. An outer surface of housing 110 may be coated and/or ribbed to increase tactile feel and improve comfort. A compressible sleeve (not shown) can be slid over housing 110 to provide additional comfort for a user. [0047] In one example embodiment, as illustrated in FIG. 1 , an ink, marker or similar writing cartridge 125 is removably disposed within housing 110 . Writing cartridge 125 has a first writing end 128 that can be disposed proximate open first end 112 of housing 110 and second securing end 129 proximate open second end 114 of housing 110 . Writing cartridge 125 can dispense an ink, a cosmetic such as eyeliner, lipstick, or the like. In one embodiment, ink cartridge 125 dispenses an ink having the properties to be initially invisible or undetectable to the naked eye, only to reappear after a duration of time or the application of heat, another chemical, or the like. [0048] Referring to FIGS. 2A-2D , and initially to FIG. 2A , a nose cap 130 can be removably disposed over open first end 112 of housing 110 to provide support to writing cartridge 125 . In one example embodiment, nose cap 130 has a generally conical shape with a generally conical tip portion 132 and a generally annular collar portion 134 . Referring to FIG. 2C , the generally annular collar portion 134 has an outer diameter generally greater than an outer diameter of tip portion 132 . As particularly illustrated in FIGS. 2B-2D , nose cap 130 can have a lower or bottom wall 135 for supporting ink cartridge 125 when disposed in housing 110 . An annular channel 136 extends into annular collar portion 134 and about bottom wall 135 for receiving open first end 112 of housing 110 . [0049] In one example embodiment, nose cap 130 can be threadedly coupled to housing 110 . In another example embodiment, nose cap 130 can be pressure fitted to housing 110 . Other fastening methods and means are also possible and should be considered to be within the spirit and scope of the invention. [0050] Referring to FIG. 2B , when nose cap 130 is disposed on housing 110 , first writing end 128 of writing cartridge 125 extends through holes 137 and 137 ′ extending through tip portion 132 and bottom wall 135 respectively. [0051] Referring to FIGS. 1 and 3 A and 3 B, a nose cap cover 141 can be provided to prevent first writing end 128 of writing cartridge 125 from drying out. The nose cap cover 141 has a top or upper wall 142 and a peripheral wall 144 extending away therefrom. Referring to FIGS. 7A-7C , peripheral wall 144 has an edge 146 defining an access opening 148 for receiving nose cap 130 . Nose cap cover 141 can comprise any generally rigid material such as plastic, wood, metal or the like. [0052] Referring to FIGS. 3C 3 D, nose cap cover 141 can include a cosmetic applicator assembly 150 operatively disposed in an interior 152 thereof for applying the cosmetic on the user. In one example embodiment, the cosmetic applicator assembly 150 comprises a brush, elongate generally absorbable pad, or other like applicator 154 that is operatively disposed in and extendable from an interior of the housing 110 . The applicator can have a first end 156 that is extendable through an opening 157 in the upper wall 142 of the nose cap cover 141 . [0053] A second end 158 of the applicator 154 can be attached to a slide mechanism 160 that is utilized by a user to move the applicator 154 between an extended position (see FIG. 3C ) and a retracted position (see FIG. 3D ). The extended position is defined by the first end 156 of the applicator 154 extending through the opening 157 of the nose cap cover 141 . The retracted position is defined by the applicator 154 being substantially enclosed in the nose cap cover 141 . [0054] In one embodiment, the slide mechanism comprises at one elongate slide 162 having a knob portion 164 extending through an elongate slot or slit 166 in the peripheral wall 144 of the nose cap cover 141 . A user can user their thumb or finger to move the knob portion 164 along the slot or slit 166 and concomitantly, vertically move the applicator 154 between the extended and retracted positions. An outer surface of the knob portion 164 can include knobs, ribs, ridges, protrusions and the like 168 to facilitate the grip of the user's thumb or finger on the knob while moving it between the extended and retracted positions. [0055] In one embodiment of the invention, as illustrated in FIG. 1 , an edge 170 defining the slot or slit 166 in the peripheral wall 144 of nose cap cover 141 can include spaced apart recesses or protrusions 172 that receive or interact with a portion of slide or knob portion 168 or slide 162 to retain the applicator in a relatively fixed position while being used. Other types of mechanisms are possible to facilitate the at least temporary fixing of the applicator 154 in either the extended or retracted position and should be considered to be within the spirit and scope of the invention. [0056] In another embodiment of the invention, the applicator 154 can be removably disposed to another portion of the housing 110 . In this embodiment, the applicator 154 can be removably disposed to the second end 114 of housing 110 or other portion conducive to holding or receiving the applicator 154 in any form. [0057] Referring to FIGS. 4A and 4B , a coupling member 180 such as an eyelet, loop, hook, strap, tether, and similar devices can be coupled to the peripheral wall 144 of nose cap cover 141 to allow a user to more easily carrying the writing instrument and cosmetic compact 100 . In an example embodiment, as illustrated in FIGS. 4A and 4B , coupling member 180 comprises an eyelet having plug portion 182 joined to and extending from an anchoring portion 184 . Plug portion 182 is adapted for operative engagement to any portion of writing instrument and cosmetic compact 100 , but preferably the peripheral wall 144 of nose cap cover 141 . [0058] In an example embodiment, plug portion 182 can include a conical section 186 disposed on an end of a shaft section 188 that is centrally disposed on anchor portion 184 . Conical section 186 is adapted for operative engagement with at least one hole 187 extending into nose cap cover 141 . [0059] Anchor portion 184 can include a base section 190 and an attachment section 192 . The shaft section 188 is disposed on an upper surface of base section 190 while the attachment section 192 is disposed on a lower surface of base section 190 . In on example embodiment, attachment section 192 comprises a loop that is adapted to receive a tether or similar device. Attachment member 180 can comprise any compressible material such as rubber, plastic and the like. [0060] Referring now to FIGS. 1 and 5 A- 5 E, at least one end cap assembly 200 is detachably couplable to the open second end 114 of housing 110 for holding the second end 129 of writing cartridge 125 . In one embodiment, end cap assembly 200 comprises an inner end cap 202 and an outer end cap 204 with the outer end cap 204 adapted to receive the inner end cap 202 and a compartment 400 adapted to hold a cosmetic. [0061] Referring to FIGS. 5A and 5B , the outer end cap 204 includes a generally centrally disposed wall 206 having a peripheral wall 208 extending diametrically from opposed surfaces of the wall 206 such that a bottom rim or lip 210 (see FIG. 5B ) of the peripheral wall 208 defines an access opening 212 for receiving the inner end cap 202 . An upper rim 214 of the peripheral wall 208 defines an access opening 216 for receiving the compartment 400 . [0062] Outer end cap 204 includes a post 217 a having a bore 217 b extending longitudinally therein for receiving and at least temporarily securing cartridge 125 . Post 217 a is centrally disposed on and extends from the central wall 206 . In another example embodiment, as particularly illustrated in FIG. 5C , post 217 a is divided along its longitudinal axis defining first 218 and second 220 post portions that extend away from each other when writing cartridge 125 is inserted in bore 217 b . In this embodiment, an inner diameter of bore 217 b is at least slightly smaller than an outer diameter of writing cartridge 125 to create a friction fit therebetween. [0063] Referring to FIGS. 5A, 5D , and 5 E, inner end cap 202 is operatively coupled between housing 110 and outer end cap 204 to secure outer end cap 204 to housing 110 . In an example embodiment, as particularly illustrated in FIG. 5D , inner end cap 202 has a top wall 222 and a peripheral wall 224 extending away therefrom forming an interior space 226 . A pair of supports 228 and 228 ′ can be disposed in and extend generally across the interior space 226 . Supports 228 and 228 ′ can comprise plates or panels having a length generally equal to a length of peripheral wall 224 . [0064] Top wall 222 of inner end cap 202 has a generally centrally disposed aperture 230 extending therethrough for receiving post 217 a . In an example embodiment, post 217 a is disposed generally between supports 228 and 228 ′. Inner end cap 202 can be secured in outer end cap 204 by an adhesive or other mechanical means such as by threaded engagement. [0065] Inner end cap 202 can also include a tab 232 extending away from an outer surface of its peripheral wall 224 for operatively engaging and securing inner end cap 202 and outer end cap 204 to housing 110 . In an example embodiment, as illustrated in FIGS. 1 , tab 232 can operatively engage a slit 234 and a notch 236 extending transversely therefrom into housing 110 . To secure inner end cap 202 to housing 110 , tab 232 is inserted and slid within slot 232 . Tab 232 becomes aligned with notch 234 . Rotation of inner end cap 204 forces tab 232 into notch 234 such that it extends transversely through notch 234 preventing its disengagement from housing 110 . Other means of engaging inner end cap 203 to housing 110 are also contemplated by the invention, for example threaded engagement, pressure fitting, and snap fitting. [0066] Referring to FIGS. 6A-7E , and initially to FIGS. 7A-7E , the compartment 240 includes a bottom wall 242 and a peripheral wall 244 extending away therefrom defining an interior 246 . A cosmetic 247 , such as lip gloss, lipstick, eye shadow, and the like is disposed in the interior 246 of the compact 240 . As illustrated in FIG. 7C , compact 240 has a generally circular cross section. However, depending upon the cross sectional shape of housing 110 and outer end cap 204 , compact 240 can have any cross sectional shape. In one embodiment, the outer end cap 204 and the compact 240 are manufactured from a clear material such that the cosmetic 247 is visible from outside of writing instrument and cosmetic compact 100 . [0067] Referring back to FIG. 5A , compact 540 has a size and shape adapted for fitting into recess opening 216 of outer end cap 204 . In one embodiment, compact 240 is pressure fitted in the access opening 216 to temporarily secure compact 240 within outer end cap 204 until a user pulls on an end of compact 240 thereby removing it from the outer end cap 204 . In another embodiment of the invention, an outer surface of the peripheral wall 244 of compact 240 may be threadedly coupled to an inner surface of the peripheral wall 208 of the outer end cap 204 . Other methods and means of coupling, securing, fixing, attaching the compact 240 to the outer end cap 204 are also possible and should be considered to be within the spirit and scope of the invention. [0068] Referring to FIGS. 7A, 7D and 7 E, a mirror or similar reflective member 300 can be coupled to outer end cap 204 to permit a user to observe themselves while applying the cosmetic. Reflective member 300 can comprise a housing 302 having a top wall 304 and a peripheral wall 306 defining an interior 308 thereof. A reflective mirror or similar surface 310 can be disposed in the interior 308 . In an alternate embodiment, an inner surface of top wall 304 can be polished to create a reflective surface, thereby eliminating the need for a separate mirror. [0069] As illustrated in FIG. 7D , a lip 312 can extend beyond the mirror. Lip 312 can be used to operatively couple reflective member 300 to the outer end cap 204 . As illustrated in FIG. 6A a pair of prongs 314 and 314 ′ can extend from lip 214 of outer end cap 204 . Each of the prongs 314 and 314 ′ includes a protrusion 316 and 316 ′ respectively that can engage a portion of reflectively member 300 . As illustrated in FIG. 7E , housing 302 of reflective member 300 can include a pair of slots 318 and 318 ′ for receiving prongs 314 and 314 ′ respectively. An inner surface of slots 318 and 318 ′ can include depressions for receiving protrusions 316 and 316 ′. In this particular embodiment, reflective member 300 is hingedly coupled to outer end cap 204 between an open position and a closed position. Reflective member 300 can also be threadedly coupled, pressure fitted, or snapped on outer end cap 204 . Other forms of engagement are also contemplated and should be considered to be within the spirit and scope of the invention. [0070] As illustrated in FIG. 6A , the compact 240 can extend beyond the lip 214 of outer end cap 204 . The reflective member 300 can include a space defined by its lip 312 such that when the reflective member 300 is in the closed position the compact 240 can extend into at least a portion of the interior 308 of the reflective member 300 . When the reflective member 300 is closed its lip 312 surrounds the compact 240 . [0071] After purchase, a user lifts the reflective member 300 exposing the compact 240 . The user can then pull, rotate, pivot and the like to remove the compact 240 from the outer end cap 204 . Once the compact 240 has been removed, the user can press, slide, or otherwise move knob portion 164 such that the first end 156 of the applicator 154 extends through the opening 157 of the nose cap cover 141 . [0072] The user then places the tip or first end 156 of the applicator 154 into the cosmetic 247 to pick up some cosmetic for placing on their lips, eyelids or other bodily features. A user can then retract the applicator 154 back into the nose cap cover 141 for storage. [0073] A user can also remove the nose cap cover 141 to expose the cartridge 125 to right a message, note, and the like on a piece of paper. However, upon writing a message on the substrate, a user notices that no ink has apparently been disposed on the substrate. In example embodiments, the ink can reappear after a predefined period of time; if the user blows their warm breath on the ink soaked substrate; or if the user applies another chemical such as lemon juice and the like. [0074] In another embodiment, the ink may comprise a chemical or material, such as luminol. Once a light is placed on the ink soaked substrate it will illuminate the written message. [0075] In yet another embodiment, a user can write a message in reverse with the invisible ink contained in the ink cartridge 125 . Another user can then use reflective member 300 and the light chemical, breath and the like to read the reversed message. [0076] In another embodiment, wipes impregnated or soaked in a cleaning solution can be rolled up and placed in the interior of housing 110 such that when a user wants to remove the cosmetic they can pull the wipe through slit 234 of the housing 110 . In this example embodiment, the roll of wipes can include a plurality of wipes connected linearly by spaced transversally extending perforations. [0077] Numerous modifications are also contemplated in the present invention. For example, all parts of writing instrument and cosmetic compact 100 can be manufactured from a single material or they may comprise any combination of various materials. Advertising, logos, designs and other indicia can be imprinted or imparted on any component of writing instrument and cosmetic compact 100 including, but not limited to, housing 110 , nose cap 130 , cover 160 , nose cap cover 140 , and/or end cap 170 . [0078] The present invention may be embodied in these and other specific forms without departing from the spirit or essential attributes thereof, and it is therefore desired that the present embodiment be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.

A writing instrument and cosmetic compact having a writing cartridge disposed in a housing or barrel adapted to receive a compact designed to hold a cosmetic or similar makeup. The ink cartridge can be filled with an ink that is only visible upon interaction with another medium such as a light source, another chemical, or warmed or heated air.

RELATED APPLICATIONS [0001] The present application is a continuation of U.S. application Ser. No. 10/272,209 filed Oct. 15, 2002, which claims priority 35 U.S.C. §119(e) to U.S. Provisional Application No. 60/343,627 filed Oct. 22, 2001, the disclosures of which are incorporated by reference herein in their entirety. FIELD OF THE INVENTION [0002] The present invention relates to a device for facilitating the insertion of a guide wire into a catheter lumen in a manner that the device can be removed from the guide wire while the guide wire remains loaded into the catheter. BACKGROUND OF THE INVENTION [0003] In the treatment of human diseases and disorders, clinicians and interventionalists often routinely use some form of catheter based treatment system, whether for the aspiration or infusion of fluids, or for more elaborate procedures such as angioplasty. To advance a catheter or other tubular member within a patient's vasculature or other systemic lumen, it is often desired to use a guide wire pre-inserted into the patient to first locate and then preserve the pathway for the catheter. The catheter is advanced over the guide wire to a desired distal location, at which point the guide wire may be left in place or removed. [0004] A difficulty encountered in the use of a guide wire and catheter treatment system is inserting the guide wire through the lumen of the catheter. The internal lumen of catheters used in many different applications tends to be rather small, as small as 0.010 inches. In contrast, guide wires tend to have a diameter only a few thousands of an inch smaller than the intended lumen. Coupled with the fact that the distal end of a catheter is often tapered, the insertion of the proximal end of the guide wire into the distal end of the catheter or other tubular member is difficult at best. The resiliency of the catheter material adds to the difficulty. In the circumstances of medical intervention, such as a catheterization lab, where the lighting may be poor, intentionally or unintentionally, the difficulty of guide wire insertion is exacerbated. [0005] There have been efforts made to address this difficulty. For example, U.S. Pat. No. 5,320,613 to Houge et al. discloses a device that facilitates insertion of a guide wire into a catheter lumen. However, the Houge et al. device is flawed in that a longitudinal groove or slot is provided along the length of the device that has a width that is greater than the guide wire to permit the lateral removal of the guide wire from the device. The slot requires that the clinician hold his/her thumb over the slot to permit the guide wire insertion process to proceed. An alternative embodiment disclosed by Houge et al. adds a rotatable cover sleeve that covers the slot during use and, when rotated to expose the slot, permits removal of the guide wire after use. [0006] U.S. Pat. No. 5,978,699 to Fehse et al. also discloses a device that facilitates insertion of a guide wire into a catheter lumen. However, the Fehse et al. device is also flawed in that it presents a large cumbersome configuration that relies upon a hinged format to create a longitudinal slot through which the guide wire may be removed after use. [0007] The present invention reflects an improvement over the prior art by providing a self-contained guide wire insertion tool that is streamlined in configuration and avoids the need for an additional cover sleeve or the need for the clinician to hold his/her thumb over a removal slot. SUMMARY OF THE INVENTION [0008] The present invention comprises a device for introducing a guide wire into a catheter, where the device comprises a housing having at least one lumen for permitting the passage of a guide wire therethrough. The lumen has an axial single seam positioned longitudinally along the lumen that is defined by opposite lateral ends of the housing. The seam comprises a gap that is dimensioned less than the diameter of the guide wire to be passed therethrough for preventing lateral removal of the guide wire from said device during use. The housing further comprises a plurality of gripping surfaces distinct from the seam for permitting a user to widen the seam to facilitate removal of a guide wire. The housing may further include an axial notch positioned generally about 180 degrees opposite from the seam to facilitate widening of the seam when it desired to remove the guide wire. The join may comprise a longitudinal groove on the housing. The gripable surfaces may each comprise a tab, or may comprise an indentation in the housing. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is a side schematic view of the present invention insertion tool. [0010] FIG. 2 is an end schematic view of the device of FIG. 1 taken along lines 2 - 2 . [0011] FIG. 3 is a side cross-sectional schematic view of the device of FIG. 1 taken along lines 3 - 3 . [0012] FIG. 4 is a schematic view of the present invention insertion tool engaging a catheter through which it is desired to advance a guide wire. [0013] FIG. 5 is a cross-section schematic of the arrangement shown in FIG. 4 . DETAILED DESCRIPTION OF THE INVENTION [0014] Referring to FIGS. 1-3 , the invention comprises a guide wire insertion tool 10 that itself comprises a housing 12 having a proximal end 14 , a distal end 16 , and a mid-section 18 therebetween. Traversing longitudinally through the housing is a lumen 20 of sufficient diameter to permit the axial passage of a guide wire therethrough. Either of the proximal or distal end may be fitted with a Luer fitting (not shown) for engagement with a mating Luer fitting of a discrete piece. The insertion tool also includes a means for separating the insertion tool from a guide wire after use. In a first embodiment, the housing is configured in a rolled format so as to comprise one configuration of separating means: two lateral sides 24 and 26 spaced apart to define an already exposed seam 30 . The seam 30 of this first embodiment comprises a gap that is sufficiently small in its normal position to preclude the unintended removal of the guide wire from the housing during use. [0015] The housing 12 is preferably tapered radially outward from the mid-section 18 toward the proximal end 14 and distal end 16 , respectively so as to provide a funnel-like appearance. The large diameter ends define proximal and distal openings 32 and 34 that serve to permit easy feeding of a guide wire into the lumen 20 . Like the profile of the housing, the profile of the lumen 20 preferably has a taper extending radially outward from the mid-section 18 toward the proximal end 14 and distal end 16 . Having a tapered lumen facilitates effective engagement of the insertion tool 10 with a catheter during use, as explained more fully below. The interior surface of the lumen 20 is preferably smooth and untextured, although it is not necessary for effective operation. Within the mid-section, the lumen preferably has a diameter only slightly larger than the diameter of the guide wire to restrict undesired lateral movement of the guide wire, which permits greater control during advancement of the guide wire through the insertion tool. In one embodiment, for guide wires having diameters approximately 0.014 inches, it is contemplated that the interior diameter of lumen 20 within mid-section 18 would be approximately 0.017 inches, although other diameters would be effective. [0016] In the preferred embodiment, each of the proximal end 14 and distal end 16 includes a recess 38 that serves the purpose of directing the guide wire through seam 30 when it is desired to remove the guide wire from the insertion tool, although such a recess is not necessary for effective use. When removing the guide wire insertion tool 10 from a guide wire, the tool 10 may be angled in such a way that the guide wire is directed to one of the recesses 38 on the tool. Once the guide wire is at the notched location, the tool may continue to be angled in such a way that the guide wire is urged through seam 30 . In this manner, the tool may be removed from around the guide wire, using only tactile feel, without looking at the guide wire or tool. [0017] The separating means of housing 12 further comprises means for gripping the housing in a manner that permits widening the seam 30 to permit separation of the guide wire form the insertion tool 10 . In one embodiment, shown in FIGS. 1 and 2 , the gripping means comprises separator tabs 40 extending radially outward from the housing surface. The tabs 40 are joined to the housing 12 at opposite sides of the seam 30 to permit a user to grip the tabs 40 and pull them apart. Doing so results in the seam gap widening sufficiently to permit removal of the guide wire. The tabs may be positioned directly across from each other, or may be positioned longitudinally offset from each other. In the former case, the separator tabs 40 should be spaced apart to permit the user to effectively grasp the tabs. Other arrangements for the tab are also contemplated, so long as they permit the user to grip the tabs and widen the seam 30 for guide wire separation. The tabs 40 may be made integral with the housing or may be discrete components attached to the housing. In another embodiment of the separating means, the gripping means may comprise indentations in the housing at the already exposed seam that permit the user to grip opposing lateral sides 24 and 26 of the housing to widen the seam gap. [0018] The insertion tool may optionally further comprise means for facilitating widening of the seam 30 . In the preferred embodiment, the facilitating means comprises a longitudinally extending notch 44 , as shown more clearly in FIG. 2 . Given housing material that is sufficiently pliable, the notch 44 facilitates widening of the housing seam 30 by reducing the thickness of the housing wall at a point radially opposite of the seam 30 . That reduced wall thickness results in a weaker resistance to radial bending of the housing 12 , thus facilitating widening of the seam 30 . In effect, the notch 44 presents a living hinge-like arrangement. In an alternative embodiment, the housing material is sufficiently rigid that the housing intentionally breaks at the notch. In that embodiment, widening of the seam is not the goal. Other configurations for the facilitating means are also contemplated, including longitudinal scoring that results in a weakened housing portion, and other means known to persons of ordinary skill in the art. Indeed, no notch or scoring is necessary if it is desired nearly to have the facilitating means comprise a thinner wall that permits resilient bending of the wall at the thinner wall area. [0019] As described above, the already exposed seam 30 through which the guide wire may be separated from the insertion tool 10 is preferably defined by opposing lateral sides of the housing 12 . Other means for separating the guide wire from the housing are contemplated. For example, instead of an exposed seam, the housing may comprise a longitudinally arranged set of perforations that permit the user to break the housing wall at the perforations for guide wire separation. Such an arrangement would further comprise gripping means that may be similar to that described above, or some other effective gripping means. Yet another alternative embodiment of separating means comprises a tearable housing wall portion that would permit a user, by gripping a tab or other like grabable protrusion, to remove a longitudinal section of the housing wall from proximal end to distal end (or vice versa), thereby exposing a seam for separation of the guide wire from the insertion tool. No gripping means for widening the seam would be necessary with such an arrangement. With at least some of these alternative arrangements, means for facilitating widening of the seam may be used if so desired. [0020] Referring to FIGS. 4 and 5 , the present invention also comprises one or more methods of using the inventive insertion tool 10 in which one method comprises the step inserting the distal end of a catheter 60 into the proximal end 14 of the housing 12 to permit fairly tight engagement of the catheter tip with the interior tapered portion of lumen 20 . Often distal tips of catheters are themselves tapered, permitting more effective engagement with the tapered portion of lumen 20 , as shown more clearly in FIG. 5 . The method further comprises the steps of inserting a guide wire 70 into the distal end 16 of the housing and advancing the guide wire through the lumen 20 into the mid-section 18 . Continued advancement of the guide wire 70 results in the guide wire 70 being smoothly directed into the distal end of catheter 60 . Once the guide wire 70 is sufficiently advanced within the catheter, the insertion tool 10 is no longer needed and may be separated from the guide wire following the inventive steps. With one embodiment described herein, the method further comprises gripping the gripping means, in one case tabs 40 , to widen the seam 30 and permit removal of the guide wire from lumen 20 . Once the insertion tool 10 is separated, the clinician may then proceed with further treatment of the patient by advancing the catheter 60 along the guide wire 70 into the patient. Alternative methods comprise the alternative step of using an insertion tool that employs indentations rather than gripping tabs, that permit a user to grip the housing in such a away as to widen the seam. Alternative steps include gripping a pull tab longitudinally along the housing to expose a seam that is sufficiently wide to permit separation of the guide wire. [0021] It is contemplated that the present inventive insertion tool 10 be made of material that is sufficiently rigid and stable to permit insertion and advancement of a guide wire into the housing 12 , yet sufficiently resilient to permit opening of the seam to remove the guide wire. In one preferred embodiment, the housing 12 is made of a thermoplastic rubber (TPR) such as that sold under the brand name Santoprene®, for example. Other medical grade materials may also be used as well, including metals, metal alloys, silicone, polymers such as polycarbonate, polyethylene, polyester, polypropylene, polyurethane, fluoropolymers, PVC or other polymers, including those sold under the trade names Pebax® and Surlyn®. The contemplated hardness is preferably approximately 70-100 on the Shore A scale and approximately 20-50 on the Shore D scale. It should be recognized that materials having a finished hardness outside this range would also be effective for the application described herein. The insertion device of the present invention may incorporate a biocompatible fluorescing feature, making the device easier to see in the clinical setting. The florescence may be realized by using a coating, or by including fluorescing materials during the compounding or molding (or other) manufacturing processes. Also, the external surface of the housing may be textured to provide better gripping by the clinician. [0022] Contemplated methods of manufacture include injection molding, casting, machining, extrusion, a combination of any of these, or some other suitable manufacturing method. The insertion tool may be made of unitary construction, or a combination of assembled components. [0023] One anticipated advantage of the present inventive insertion tool is that is may be reusable during multiple catheter insertions for a single patient. By employing a living hinge in the design, i.e., the longitudinal notch that permits the seam to be widened without breaking the housing, the present invention is reusable, provided adequate sterilization procedures are applied. Being reusable for a single patient reduces the incremental cost per procedure and further increases the speed and ease of use. Since multiple wire exchanges are done on a single patient, being able to reuse cuts down on the incremental time to open additional packages associated with incremental wire exchanges. [0024] It should be noted that the present invention insertion tool may also be used outside the clinical context for the feeding of any thin object into a correspondingly thin opening. It is also contemplated that a set of insertion tools may be provided, each with a different diameter lumen for guiding differently sized objects therethrough, where removal of the tool from around the side is useful.

A device for introducing a guide wire into a catheter comprising a housing having at least one lumen for permitting the passage of a guide wire therethrough. The lumen has an axial single seam positioned longitudinally along the lumen that is defined by opposite lateral ends of the housing. The seam comprises a gap that is dimensioned less than the diameter of the guide wire to be passed therethrough for preventing lateral removal of the guide wire from said device during use. The housing further comprises a plurality of gripping surfaces distinct from the seam for permitting a user to widen the seam to facilitate removal of a guide wire. The housing may further include an axial notch positioned generally about 180 degrees opposite from the seam to facilitate widening of the seam when it desired to remove the guide wire. The join may comprise a longitudinal groove on the housing. The gripable surfaces may each comprise a tab, or may comprise an indentation in the housing.

This application is a continuation of application Ser. No. 08/031,960, filed Mar. 16, 1993 abandoned. FIELD OF THE INVENTION The present invention relates to fluorocarbon compositions containing a visualizable label, and to their use in visualizing animal cells or tissues. BACKGROUND OF THE INVENTION Liquid fluorocarbons have a high affinity for oxygen and can dissolve or solubilize significant quantities of oxygen. For this reason, fluorocarbon emulsions have been used as biocompatible oxygen carriers and/or blood substitutes. Fluorocarbon liquids have also been used as radiological imaging agents. See e.g., U.S. Pat. Nos. 3,975,512 and 4,987,154. Fluorocarbon liquids have also been used in magnetic resonance imaging. See e.g., U.S. Pat. No. 4,951,673. In many instances it is desirable to directly visualize animal tissues or cells. Staining of tissues with tissue-specific dyes is a common histological technique. However, for certain tissues and cells, such as those reticuloendothelial (RES) system, there remains a need for better visualization techniques. A surgeon, for example, may use a radiological lymphographic technique to prepare presurgical films or pictures which indicate the location of lymphatic tissue in a patient. However, during surgery, working in the surgical incision, it may be more difficult to differentiate the tissue in question. Similarly, in research applications, it is often desirable to identify and label certain tissues, such as RES tissues. The present invention provides a ready mechanism for locating and visually identifying certain cells and tissues. SUMMARY OF THE INVENTION One aspect of the present invention is a fluorocarbon composition, comprising a Physiologically-acceptable liquid fluorocarbon, and a visualizable label associated with the fluorocarbon. The composition may further comprise an aqueous phase, and an emulsifier, wherein the composition is an emulsion and the liquid fluorocarbon comprises a fluorocarbon phase of the emulsion. In one embodiment, the label is a fluorescent label. Preferably, the label is hydrophobic and is associated with the fluorocarbon phase or with the emulsifier by lipophilic or hydrophobic interaction. The label may also be a visible dye. The invention also includes a method for visualizing cells or tissue of an animal, comprising the steps of providing a fluorocarbon composition comprising a liquid fluorocarbon and a visualizable label associated therewith, administering the composition to the animal in vivo, permitting the composition to localize in cells or tissue, and visualizing the cells or tissue in which the fluorocarbon has localized. Preferably, the fluorocarbon composition is an emulsion and further comprises a continuous aqueous phase and an emulsifier, and the liquid fluorocarbon preferably comprises a discontinuous phase of the emulsion. In one embodiment, the discontinuous phase localizes in cells of the reticuloendothelial system. As above, the label may be fluorescent or may be a visible chromophore. The label is preferably hydrophobic and is associated with the discontinuous phase or the emulsifier by lipophilic or hydrophobic interaction. One particularly interesting use of this method is for visualizing lymph nodes or lymphatic vessels. DETAILED DESCRIPTION OF THE INVENTION The present invention utilizes fluorocarbons associated with a visualizable label, such as a visible or fluorescent dye or other chromophore, for marking tissues and cells. Unlike prior uses of fluorocarbons for radiographic, ultrasonic, or magnetic resonance imaging, the labelled fluorocarbons of the present invention may be directly visualized, with visible or ultraviolet light. In one embodiment of the present invention, the fluorocarbon is in the form of a emulsion. Fluorocarbon emulsions are well known. Such emulsions comprise an aqueous phase, an emulsifier, and a fluorocarbon phase. Both oil-in-water and water-in-oil emulsions can be prepared. These emulsion may be prepared using known techniques. See, e.g., U.S. Pat. Nos. 4,987,154 and 4,865,836. Suitable fluorocarbons for use in the present invention include any biologically compatible fluorocarbon. There are a number of fluorocarbons that have been disclosed for medical use. These fluorocarbons include his (F-alkyl) ethanes such as C 4 F 9 CH═CH 4 CF 9 (sometimes designated "F-44E"), i-C 3 F 9 CH═CHC 6 F 13 ("F-i36E"), and C 6 F 13 CH═CHC 6 F 13 ("F-66E"), cyclic fluorocarbons, such as C10F18 ( "F-decalin," "perfluorodecalin" or "FDC"), F-adamantane ("FA"), F-methyladamantane ("FMA") , F-1,3-dimethyladamantane ("FDMA") , F-di-or F-trimethylbicyclo[3,3,1]nonane ("nonane"); perfluorinated amines, such as F-tripropylamine ("FTPA") and F-tri-butylamine ("FTBA") , F-4-methyloctahydroquinolizine ("FMOQ") , F-n-methyl-decahydroisoquinoline ("FMIQ") , F-n-methyldecahydroquinoline ("FHQ") , F-n-cyclohexylpurrolidine ("FCHP") and F-2-butyltetrahydrofuran ("FC-75" or "RM101"). Other fluorocarbons include brominated perfluorocarbons, such as 1-bromo-heptadecafluoro-octane (C 8 F 17 Br, sometimes designated perfluorooctylbromide or "PFOB"), 1-bromopentadecafluoroheptane (C 7 F 15 Br) , and 1-bromotridecafluorohexane (C 6 F 13 Br, sometimes known as perfluorohexylbromide or "PFHB"). Other brominated fluorocarbons are disclosed in U.S. Pat. No. 3,975,512 to Long. Also contemplated are fluorocarbons having nonfluorine substituents, such as perfluorooctyl chloride, perfluorooctyl hydride, and similar compounds having different numbers of carbon atoms. Additional fluorocarbons contemplated in accordance with this invention include perfluoroalkylated ethers or polyethers, such as (CF 3 ) 2 CFO(CF 2 CF 2 ) 2 OCF(CF 3 ) 2 , (CF 3 ) 2 CFO(CF 2 CF 2 ) 3 OCF(CF 3 ), (CF 3 )CFO(CF 2 CF 2 )F, (CF 3 ) 2 CFO(CF 2 CF 2 ) 2 F, (C 6 F 13 ) 2 O. Further, fluorocarbon-hydrocarbon compounds, such as, for example compounds having the general formula C n F 2n+1 C n' F 2n'+1 , C n F 2n+1 OC n' F 2n'+1 , OR C n F 2n+1 CF═CHC n' F 2n'+1 , where n and n' are the same or different and are from about 1 to about 10 (so long as the compound is a liquid at room temperature). Such compounds, for example, including C 8 F 17 C 2 H 5 and C 6 F 13 CH═CHC 6 H 13 . It will be appreciated that esters, thioethers, and other variously modified mixed fluorocarbon-hydrocarbon compounds are also encompassed within the broad definition of "fluorocarbon" materials suitable for use in the present invention. Mixtures of fluorocarbons are also contemplated. Additional "fluorocarbons" not listed here, but having those properties described in this disclosure are additionally contemplated. The emulsifier used in preparing the emulsion may be any suitable material, such as pluronic, nonionic surfactant, any of the fluorinated surfactants, or phospholipid emulsifiers, such as lecithin. Egg yolk phospholipid is particularly preferred. The surfactant typically comprises from about 2% to about 8% of the emulsion, w/v, and the fluorocarbon comprises from about 5% or 10% to about 90%, 100%, or 125%, w/v. (Because their density is about 2, the weight percentage of fluorocarbon in the emulsion can exceed 100%.) The visualizable label may be selected from a wide variety of known labels. The label used in the present invention may be selected from the large number of conventional dyes, pigments, chromophores, and the like. It is preferred that the dye is lipophilic, or that it at least contains a lipophilic moiety. Alternatively, the dye may contain a fluorophilic moiety, and in certain instances, may be a fluorocarbon. The labels of the present invention, for example, may include the following known chromophores: nitroso groups, nitro groups, azo groups, disazo groups, trisazo groups, polyazo groups, azoic groups, such as nitrosamine and diazo amino groups, stilbene groups, diphenylmethane (ketone imine) groups, triarylmethane groups, naphthyl groups, xanthene groups, thiazole groups, azines, oxizines, thiazines, amino ketones, indigoid groups, thioindigoid groups, and the like. Fluorinated derivatives of the foregoing are also contemplated. Phosphorescent labels may be used. Many of the xanthene and naphthalene-type dyes are fluorescent. Fluorescein is a well known example. One preferred category of fluorescent dye is disclosed in U.S. Pat. No. 4,783,401. These materials are long chain lipid-like cyanine compounds, which are commercially available from Zynaxis Cell Science, Inc., Melvern, Pa., under the trademark PKH-26™. Although water soluble dyes may be used, such dyes remain largely in the aqueous phase and do not remain with the emulsion particles, except in the case of a water-in-fluorocarbon emulsion. On the other hand, the lipid-like labels such as those disclosed in U.S. Pat. No. 4,783,401 remain with the fluorocarbon droplet, apparently as a result of lipophilic or hydrophobic interaction with the surfactant or with the fluorocarbon. Another group of labels which may be advantageously used in the present invention are fluorescent, fluorinated aromatic molecules. Such molecules include octafluoronaphthalene, which has a fluorescent emission maximum at about 354 nm at an excitation wave length of 339 nm. Other fluorinated aromatics which would be soluble in the fluorocarbon phase and which are expected to be highly fluorescent may also be used, such as F-pyrene and F-anthracene. Additional suitable labels may be selected, for example, from those listed in the Sigma-Aldrich Handbook of Stains, Dyes and Indicators, F. J. Green (Aldrich Chemical Company, Milwaukee, Wis. 1990). The fluorocarbons of the present invention may be used in cell culture applications, or more importantly, in vivo. Neat fluorocarbon containing the label may be introduced into the lungs or the gastrointestinal tract of an animal. Gastrointestinal administration may aid in visualization during surgical treatment of obstructions, for example. Fluorocarbon emulsions of the present invention may be administered intravenously, intraperitoneally, subcutaneously, or directly into a lymphatic vessel. In each instance, the labeled perfluorocarbon in the tissue in question may be utilized to label or visualize that tissue. Fluorocarbon emulsions tend to collect as a ring of enhancement around liver tumors, for example, 24 to 48 hours after IV administration. Fluorescent visualization of the fluorocarbon could facilitate surgical resection of such tumors. Moreover, it is contemplated that both fluorescent and visible dyes could be added to the same emulsion. One particularly attractive method for using the technology of the present invention is in labeling the cells an organs of the RES system. Emulsified fluorocarbon materials tend to accumulate in RES organs such as the spleen and the lymph system. Moreover, fluorocarbon emulsions may be administered directly .into lymphatic vessels (as in conventional lymphography). Alternatively, the lymphatic system, including vessels and lymph nodes, may be visualized by injecting fluorocarbon emulsion into tissues drained by the lymph nodes and vessels to be visualized. This technique is known as indirect lymphography. See, e.g., Wolf, et al, U.S. Pat. No. 5,114,703. It is believed that phagocytic cells such as lymphocytes pick up and internalize the fluorocarbon particles from the emulsion. These particles are transported through the lymphatic system where they accumulate in lymph nodes and in the spleen. Imaging of lymph nodes, for example, is not only valuable in research applications; it is also of significant value in surgery. Often, biopsy or lymphectomy procedures are performed in which it is important to identify and remove the tissue in question. Removal of lymph nodes is desirable, for example, in surgical treatments of certain tumors. The ability to visualize the lymph nodes during such surgery (either directly or through fluorescence) is an important advantage of the present invention. It is of similar value in post surgical examination of tissue removed from the patient. The invention may be more fully understood with reference to the following example: EXAMPLE 1 Transport of Perfluorocarbon Emulsion From Subcutaneous Tissue to Regional Lymphatics A 60% w/v perfluhron emulsion (IMAGENT® LN, Alliance Pharmaceutical Corp., San Diego, Calif.) Was combined with a fluorescent cyanine dye having long chain lipid-like characteristics (PKH-26, Zynaxis Cell Science, Inc., Melvern, Pa.). In particular, a 10 -3 M stock solution of PKH-26 was added to the perfluhron emulsion to provide a final concentration of PKH-26 of 10 -5 M. The mixture was gently shaken in the dark for five minutes at room temperature (22° C.). Subsequently, the mixture was added to the same amount of fresh rabbit plasma and was gently mixed for one minute to stop the staining reaction. This suspension had a final concentration of 30% perfluhron, w/v. The resulting material was injected subcutaneously into the dorsal skin of the foot of anesthetized rabbits. Following injection, the foot was moved passively in a rotary direction at 0.3 Hz. Samples were collected from cannulated lower leg prenodal lymphatics over a period of two hours and were assayed for lymph flow rate, leukocyte count, and extracellular and intracellular labeled perfluorocarhon. Samples were taken at two hours, twenty four hours, and one week after injection. Following initial lymph sample collection, the foot was gently massaged for fifteen minutes and then the lymph measurements were repeated. A fluorescent microscope was used to examine samples. The intracellular flux of the perfluorocarhon was measured as a function of the fluorescence of the sample. The measured results were: ______________________________________ 2 hours 3.7 ± 3.7 × 10.sup.-6 μg/hr24 hours 72 ± 20 × 10.sup.-6 μg/hr24 hours 61 ± 16 × 10.sup.-6 μg/hr______________________________________ Extracellular flux was significantly greater at the initial stage: ______________________________________ 2 hours 1.5 ± 0.4 μg/hr24 hours 0.25 ± 0.07 μg/hr 1 week undetectable______________________________________ Examination of afferent rabbit lymph fluid using fluorescence microscopy revealed both internalized PKH-26-stained perflubron particles and freely suspended perflubron particles. These features were not visible under brightfield examination of the same field.

A composition for use in visualizing tissues comprising a physiologically-acceptable fluorocarbon liquid and a visualizable label such as a chromophore or visible or fluorescent dye associated therewith; preferably the fluorocarbon is in the form of an emulsion and the label has a lipophilic moiety. Also disclosed are methods for labeling and visualizing cells and tissue, such as those of the reticuloendothelial system.

FIELD OF THE INVENTION The present invention is generally directed to implantable medical devices, in particular to a tool for implanting electrodes and their association wires. BACKGROUND OF THE INVENTION In 1755 LeRoy passed the discharge of a Leyden jar through the orbit of a man who was blind from cataract and the patient saw “flames passing rapidly downwards.” Ever since, there has been a fascination with electrically elicited visual perception. The general concepts of electrical stimulation of retinal cells to produce these flashes of light or phosphenes has been known for quite some time. Based on these general principles, some early attempts at devising a prosthesis for aiding the visually impaired have included attaching electrodes to the head or eyelids of patients. While some of these early attempts met with some limited success, these early prosthesis devices were large, bulky and could not produce adequate simulated vision to truly aid the visually impaired. In the early 1930's, Foerster investigated the effect of electrically stimulating the exposed occipital pole of one cerebral hemisphere. He found that, when a point at the extreme occipital pole was stimulated, the patient perceived a small spot of light directly in front and motionless (a phosphene). Subsequently, Brindley and Lewin (1968) thoroughly studied electrical stimulation of the human occipital cortex. By varying the stimulation parameters, these investigators described in detail the location of the phosphenes produced relative to the specific region of the occipital cortex stimulated. These experiments demonstrated: (1) the consistent shape and position of phosphenes; (2) that increased stimulation pulse duration made phosphenes brighter; and (3) that there was no detectable interaction between neighboring electrodes which were as close as 2.4 mm apart. As intraocular surgical techniques have advanced, it has become possible to apply stimulation on small groups and even on individual retinal cells to generate focused phosphenes through devices implanted within the eye itself. This has sparked renewed interest in developing methods and apparati to aid the visually impaired. Specifically, great effort has been expended in the area of intraocular retinal prosthesis devices in an effort to restore vision in cases where blindness is caused by photoreceptor degenerative retinal diseases such as retinitis pigmentosa and age related macular degeneration which affect millions of people worldwide. Neural tissue can be artificially stimulated and activated by prosthetic devices that pass pulses of electrical current through electrodes on such a device. The passage of current causes changes in electrical potentials across neuronal membranes, which can initiate neuron action potentials, which are the means of information transfer in the nervous system. Based on this mechanism, it is possible to input information into the nervous system by coding the information as a sequence of electrical pulses which are relayed to the nervous system via the prosthetic device. In this way, it is possible to provide artificial sensations including vision. One typical application of neural tissue stimulation is in the rehabilitation of the blind. Some forms of blindness involve selective loss of the light sensitive transducers of the retina. Other retinal neurons remain viable, however, and may be activated in the manner described above by placement of a prosthetic electrode device on the inner (toward the vitreous) retinal surface. This placement must be mechanically stable, minimize the distance between the device electrodes and the neurons, and avoid undue compression of the neurons. In 1986, Bullara (U.S. Pat. No. 4,573,481) patented an electrode assembly for surgical implantation on a nerve. The matrix was silicone with embedded iridium electrodes. The assembly fit around a nerve to stimulate it. Dawson and Radtke stimulated cat's retina by direct electrical stimulation of the retinal ganglion cell layer. These experimenters placed nine and then fourteen electrodes upon the inner retinal layer (i.e., primarily the ganglion cell layer) of two cats. Their experiments suggested that electrical stimulation of the retina with 30 to 100 uA current resulted in visual cortical responses. These experiments were carried out with needle-shaped electrodes that penetrated the surface of the retina (see also U.S. Pat. No. 4,628,933 to Michelson). The Michelson '933 apparatus includes an array of photosensitive devices on its surface that are connected to a plurality of electrodes positioned on the opposite surface of the device to stimulate the retina. These electrodes are disposed to form an array similar to a “bed of nails” having conductors which impinge directly on the retina to stimulate the retinal cells. Such a device increases the possibility of retinal trauma by the use of its “bed of nails” type electrodes that impinge directly on the retinal tissue. The art of implanting an intraocular prosthetic device to electrically stimulate the retina was advanced with the introduction of retinal tacks in retinal surgery. De Juan, et al. at Duke University Eye Center inserted retinal tacks into retinas in an effort to reattach retinas that had detached from the underlying choroid, which is the source of blood supply for the outer retina and thus the photoreceptors. See, e.g., E. de Juan, et al., 99 Am. J. Ophthalmol. 272 (1985). These retinal tacks have proved to be biocompatible and remain embedded in the retina, and choroid/sclera, effectively pinning the retina against the choroid and the posterior aspects of the globe. Retinal tacks are one way to attach a retinal array to the retina. The retina is extraordinarily fragile. In particular, retinal neurons are extremely sensitive to pressure; they will die if even a modest intraocular pressure is maintained for a prolonged period of time. Glaucoma, which is one of the leading causes of blindness in the world, can result from a chronic increase of intraocular pressure of only 10 mm Hg. Furthermore, the retina, if it is perforated or pulled, will tend to separate from the underlying epithelium, which will eventually render it functionless. Thus attachment of a conventional prosthetic retinal electrode device carries with it the risk of damage to the retina, because of the pressure that such a device could exert on the retina. Byers, et al. received U.S. Pat. No. 4,969,468 in 1990 which disclosed a “bed of nails” electrode array which in combination with processing circuitry amplifies and analyzes the signal received from the tissue and/or which generates signals which are sent to the target tissue. The penetrating electrodes are damaging to the delicate retinal tissue of a human eye and therefore are not applicable to enabling sight in the blind. In 1992 U.S. Pat. No. 5,109,844 issued to de Juan et al. on a method of stimulating the retina to enable sight in the blind wherein a voltage stimulates electrodes that are in close proximity to the retinal ganglion cells. A planar ganglion cell-stimulating electrode is positioned on or above the retinal basement membrane to enable transmission of sight-creating stimuli to the retina. The electrode is a flat array containing 64-electrodes. Norman, et al. received U.S. Pat. No. 5,215,088 in 1993 on a three-dimensional electrode device as a cortical implant for vision prosthesis. The device contains perhaps a hundred small pillars each of which penetrates the visual cortex in order to interface with neurons more effectively. The array is strong and rigid and may be made of glass and a semiconductor material. U.S. Pat. No. 5,476,494, issued to Edell, et al. in 1995, describes a retinal array held gently against the retina by a cantilever, where the cantilever is anchored some distance from the array. Thus the anchor point is removed from the area served by the array. This cantilever configuration introduces complexity and it is very difficult to control the restoring force of the cantilever due to varying eye sizes. Sugihara, et al. received U.S. Pat. No. 5,810,725 in 1998 on a planar electrode to enable stimulation and recording of nerve cells. The electrode is made of a rigid glass substrate. The lead wires which contact the electrodes are indium tin oxide covered with a conducting metal and coated with platinum containing metal. The electrodes are indium tin oxide or a highly electrically conductive metal. Several lead-wire insulating materials are disclosed including resins. U.S. Pat. No. 5,935,155, issued to Humayun, et al. in 1999, describes a visual prosthesis and method of using it. The Humayun patent includes a camera, signal processing electronics and a retinal electrode array. The retinal array is mounted inside the eye using tacks, magnets, or adhesives. Portions of the remaining parts may be mounted outside the eye. The Humayun patent describes attaching the array to the retina using retinal tacks and/or magnets. This patent does not address reduction of damage to the retina and surrounding tissue or problems caused by excessive pressure between the retinal electrode array and the retina. Mortimer's U.S. Pat. No. 5,987,361 of 1999 disclosed a flexible metal foil structure containing a series of precisely positioned holes that in turn define electrodes for neural stimulation of nerves with cuff electrodes. Silicone rubber may be used as the polymeric base layer. This electrode is for going around nerve bundles and not for planar stimulation. The retina is also very sensitive to heat. Implanting a retinal prosthesis fully within the eye may cause excessive heat buildup damaging the retina. It is, therefore, advantageous to implant an electrode array on the retina attached by a cable to heat producing electronics which are implanted somewhere outside the eye. If no electronics are implanted in the eye, it is necessary to run one wire for each electrode from the electronics package to the electrode array. These wires must be extremely thin. While grouping them together in a cable with a protective sheath provides some protection, the array and cable must be handled carefully to prevent damage to the electrode array or cable. Published US patent application 2002/0099420, Chow et al. describes a surgical tool for implantation of a retinal electrode array. The Chow device is a tube which is placed into the eye and to the implant location. Then fluid flows though the tube pushing the electrode array into place. SUMMARY OF THE INVENTION The present invention is a surgical tool for implanting an electrode array and its connected cable within an eye. The insertion tool is used to aid the surgeon in pulling the electrode wire and array through the scull, four-rectus muscles of the eye, and the sclera. The insertion tool consists of a medical grade ABS material that is commonly used in various medical products. The novel features of the invention are set forth with particularity in the appended claims. The invention will be best understood from the following description when read in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the retinal electrode array assembly showing the electrodes and signal conductors as well as mounting aperture for tacking the assembly inside the eye, wherein both the array and its associated electronics are located inside the eye. FIG. 2 is a perspective view of the retinal electrode array assembly showing the electrodes and signal conductors as well as mounting aperture for tacking the assembly inside the eye, wherein the associated electronics are located outside the eye. FIG. 3 is a perspective view of the retinal electrode array assembly wherein the array is installed inside the eye and the associated electronics are installed outside the eye at some distance from the sclera wherein the feeder cable contains both a coiled cable leading between the electronics and the sclera and a series of fixation tabs along the feeder cable for securing the feeder cable by suture. FIG. 4 is a cross-sectional view of the retinal electrode array, the sclera, the retina and the retinal electrode array showing the electrodes in contact with the retina. FIG. 5 depicts a cross-sectional view of the retinal electrode array showing a strain relief slot, strain relief internal tab and a mounting aperture through a reinforcing ring for a mounting tack to hold the array in position. FIG. 6 illustrates a cross-sectional view of the retinal electrode array showing a strain relief slot and a ferromagnetic keeper to hold the array in position. FIG. 7 illustrates a cross-sectional view of the retinal electrode array showing a strain relief slot and a mounting aperture through a reinforcing ring for a mounting tack to hold the array in position, wherein the strain relief internal tab containing the mounting aperture is thinner than the rest of the array. FIG. 8 is a perspective view of the preferred insertion tool, for inserting the array of FIGS. 1-7 , having an curved tongs and a spring base. FIG. 9 is a mechanical drawing of an alternate embodiment of the insertion tool illustrated in FIG. 8 having straight tongs and a. FIG. 10 is a perspective view of an alternate embodiment using a hinged base. FIG. 11 is a perspective view of an alternate embodiment using curved tongs and a hinged base. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following description is of the best mode presently contemplated for carrying out the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of describing the general principles of the invention. The scope of the invention should be determined with reference to the claims. FIG. 1 provides a perspective view of a preferred embodiment of the retinal electrode array (implanted by the surgical too of the resent invention), generally designated 2 , comprising oval-shaped electrode array body 4 , a plurality of electrodes 6 made of a conductive material, such as platinum or one of its alloys, but that can be made of any conductive biocompatible material such as iridium, iridium oxide or titanium nitride, and single reference electrode 6 A made of the same material as electrode 6 , wherein the electrodes are individually attached to separate conductors 8 made of a conductive material, such as platinum or one of its alloys, but which could be made of any biocompatible conductive material, that is enveloped within an insulating sheath 10 , that is preferably silicone, that carries an electrical signal to each of the electrodes 6 . “Oval-shaped” electrode array body means that the body may approximate either a square or a rectangle shape, but where the corners are rounded. The reference electrode 6 A is not necessarily stimulated, but is attached to a conductor, as are electrodes 6 . The electrodes could be used in another application as sensors to transmit electrical signals from a nerve. The electrodes 6 transmit an electrical signal to the eye while reference electrode 6 A may be used as a ground, reference, or control voltage. Electrode array body 4 is made of a soft material that is compatible with the body. In a preferred embodiment array body 4 is made of silicone having a hardness of about 50 or less on the Shore A scale as measured with a durometer. In an alternate embodiment the hardness is about 25 or less on the Shore A scale as measured with a durometer. It is a substantial goal to have electrode array body 4 in intimate contact with the retina of the eye. Strain relief internal tab 12 , defined by a strain relief slot 13 that passes through the array body 4 , contains a mounting aperture 16 for fixation of the electrode array body 4 to the retina of the eye by use of a surgical tack, although alternate means of attachment such as glue or magnets may be used. Reinforcing ring 14 is colored and opaque to facilitate locating mounting aperture 16 during surgery and may be made of tougher material, such as high toughness silicone, than the body of the electrode array body to guard against tearing. Signal conductors 8 are located in an insulated flexible feeder cable 18 carrying electrical impulses from the electronics 20 to the electrodes 6 , although the electrodes can be sensors that carry a signal back to the electronics. Signal conductors 8 can be wires, as shown, or in an alternative embodiment, a thin electrically conductive film, such as platinum, deposited by sputtering or an alternative thin film deposition method. In a preferred embodiment, the entire retinal electrode array 2 including the feeder cable 18 and electronics 6 are all implanted inside the eye. Electronics 20 may be fixated inside the eye to the sclera by sutures or staples that pass through fixation tabs 24 . The conductors are covered with silicone insulation. Grasping handle 46 is located on the surface of electrode array body 4 to enable its placement by a surgeon using forceps or by placing a surgical tool into the hole formed by grasping handle 46 . Grasping handle 46 avoids damage to the electrode body that might be caused by the surgeon grasping the electrode body directly. Grasping handle 46 also minimizes trauma and stress-related damage to the eye during surgical implantation by providing the surgeon a convenient method of manipulating electrode array body 4 . Grasping handle 46 is made of silicone having a hardness of about 50 on the Shore A scale as measured with a durometer. A preferred embodiment of the electrode array body 4 is made of a very soft silicone having hardness of 50 or less on the Shore A scale as measured with a durometer. The reinforcing ring 14 is made of opaque silicone having a hardness of 50 on the Shore A scale as measured with a durometer. FIG. 2 provides a perspective view of the retinal electrode array assembly 2 wherein the electrode array body 4 is implanted inside the eye and the electronics 20 are placed outside the eye with the feeder cable 18 passing through sclera 30 . In this embodiment, electronics 38 are attached by fixation tabs 24 outside the eye to sclera 30 . FIG. 3 provides a perspective view of retinal electrode array 2 wherein electrode array body 4 is implanted on the retina inside the eye and electronics 38 are placed outside the eye some distance from sclera 30 wherein feeder cable 18 contains sheathed conductors 10 as silicone-filled coiled cable 22 for stress relief and flexibility between electronics 38 and electrode array body 4 . Feeder cable 18 passes through sclera 30 and contains a series of fixation tabs 24 outside the eye and along feeder cable 18 for fixating cable 18 to sclera 30 or elsewhere on the recipient subject. FIG. 4 provides a cross-sectional view of electrode array body 4 in intimate contact with retina 32 . The surface of electrode array body 4 in contact with retina 32 is a curved surface 28 substantially conforming to the spherical curvature of retina 32 to minimize stress concentrations therein. Further, the decreasing radius of spherical curvature of electrode array body 4 near its edge forms edge relief 36 that causes the edges of array body 4 to lift off the surface of retina 32 eliminating stress concentrations. The edge of electrode array body 4 has a rounded edge 34 eliminating stress and cutting of retina 32 . The axis of feeder cable 18 is at right angles to the plane of this cross-sectional view. Feeder cable 18 is covered with silicone. FIG. 5 provides a cross-sectional view of electrode array body 4 showing spherically curved surface 28 , strain relief slot 13 and mounting aperture 16 through which a tack passes to hold array body 4 in intimate contact with the eye. Mounting aperture 16 is located in the center of reinforcing ring 14 that is opaque and colored differently from the remainder of array body 4 , making mounting aperture 16 visible to the surgeon. Reinforcing ring 14 is made of a strong material such as tough silicone, which also resists tearing during and after surgery. Strain relief slot 13 forms strain relief internal tab 12 in which reinforcing ring 14 is located. Stresses that would otherwise arise in the eye from tacking array body 4 to the eye through mounting aperture 16 are relieved by virtue of the tack being located on strain relief internal tab 12 . FIG. 6 provides a cross-sectional view of a preferred embodiment of electrode array body 4 showing ferromagnetic keeper 40 that holds electrode array body 4 in position against the retina by virtue of an attractive force between keeper 40 and a magnet located on and attached to the eye. FIG. 7 is a cross-sectional view of the electrode array body 4 wherein internal tab 12 is thinner than the rest of electrode array body 4 , making this section more flexible and less likely to transmit attachment induced stresses to the retina. This embodiment allows greater pressure between array body 4 and the retina at the point of attachment, and a lesser pressure at other locations on array body 4 , thus reducing stress concentrations and irritation and damage to the retina. FIG. 8 is a perspective view of the preferred insertion tool 50 . The electrode array body 4 and feeder cable 18 are extremely delicate. They must pass through a hole in the scull, pass under the four-rectus muscles of the eye, through the sclera and be attached to the retina. The insertion tool 50 has a rounded point 52 for gently separating muscle and flesh as the tool is passed through. The rounded point 52 is rigidly attached to a base 54 and top 56 . Both the base 54 and the top 58 are rounded on the outside and square on the inside. The rounding helps the tool pass through flesh without causing damage. The electrode body 4 is place between the base 54 and top 58 . Spring force traps the electrode array body 4 between the base 54 and top 58 . The tool further includes a radius 64 between the base 54 and the top 58 , which provides a space between the base 54 and the top 58 such that even pressure is applied along the length of the base 54 and the top 58 . The radius 64 reduces stress concentrations that could crack the tool at the junction of the base and top with the base and top are deflected while loading or unloading the electrode array. The even pressure allows a surgeon to hold the electrode array body 4 and feeder cable 18 firmly without causing unnecessary stress on the electrode array body 4 . The tool is fashioned from an inert biocompatible material that includes resilient elastic properties such ABS, stainless steel or titanium. ABS is suitable as a single use, disposable surgical tool while stainless steel or titanium could be steam sterilized and reused. Once the electrode array body 4 and the feeder cable 18 are safely held in the surgical tool 50 , the surgeon can pass the tool 50 , electrode array body 4 and the feeder cable 18 in the same manner as a needle and thread. The preferred surgical tool 50 is curved to promote easy movement around the eye. The curvature of the tool generally conforms to the curvature of the outside of the sclera. Alternatively the surgical tool may be strait as shown in FIG. 9 . FIG. 9 shows an alternate embodiment of the surgical tool 150 . The alternate surgical tool 150 has a strait base 54 and top 58 , while retaining the radius 164 and rounded point 152 of the preferred embodiment. There are advantages to strait and curved surgical tools for much the same reasons there are advantages to strait and curved needles. Different surgeons may prefer different tools. FIG. 10 shows another alternate embodiment. Rather than relying on spring force to hold the electrode array body 4 and the feeder cable 18 in the tool 250 . The base 254 is rigidly attached to the rounded point 252 , but the top 258 is attached by a hinge 256 to the base 254 and rounded point 252 . This allows the surgeon more control of the force applied to the electrode array body 4 and the feeder cable 18 . The hinge 256 further provides for easier loading and unloading of the electrode array. This embodiment retains the radius 264 to provide even pressure along the lengths of the base 254 and the top 258 . This embodiment further includes notches 260 in the base 254 , which mate with guides 262 in the top 258 to hold the electrode array body 4 and the feeder cable 18 in the tool 250 , by holding the top 258 and base 254 together. The radius 264 reduces stress concentrations that could crack the tool at the junction of the base and top with the base and top are deflected while loading or unloading the electrode array. FIG. 11 shows another alternate embodiment, similar to that shown in FIG. 12 . The base 354 is rigidly attached to the rounded point 352 , but the top 358 is attached by a hinge 356 to the base 354 and rounded point 352 . The hinge 356 further provides for easier loading and unloading of the electrode array. This embodiment retains the radius 264 to provide even pressure along the lengths of the base 354 and the top 358 . However, the base 354 and top 358 are curved to allow for easier insertion of the tool. This embodiment further includes a keeper 360 attached to the base 354 , which covers the top 358 to limit movement and prevents opening the tool and possibly dropping the array body 4 . While the invention has been described by means of specific embodiments and applications thereof, it is understood that numerous modifications and variations could be made thereto by those skilled in the art without departing from the spirit and scope of the invention.

The present invention is a surgical tool for implanting an electrode array and its connected cable within an orbital socket. The insertion tool is used to aid the surgeon in pulling the electrode wire and array through the scull, four-rectus muscles of the eye, and the sclera. The insertion tool consists of a medical grade ABS material that is commonly used in various medical products.

FIELD OF THE INVENTION [0001] The present invention relates generally to pesticide products formulated as aqueous solutions. More particularly, it relates to aqueous compositions which contain the herbicide N-phosphonomethyl glycine (“glyphosate”) in the form of a salt other than its potassium salt, and preferably its mono-iso-propylamine salt. BACKGROUND INFORMATION [0002] The present invention pertains to liquid compositions of matter useful as herbicides and to liquid concentrates from which liquid herbicides may be prepared, wherein the active herbicidal ingredient is a salt of N-phosphonomethyl glycine, which is commonly referred to as glyphosate by those skilled in this art. Owing to the fact that glyphosate in its acid form has a low solubility in water, those skilled in the art who produce and/or use formulations containing glyphosate have found it beneficial to employ a water-soluble glyphosate salt in their formulations in order to achieve higher levels of glyphosate effectively dissolved in the solutions. This is regarded as being common knowledge in the art, and salts typically employed are the amine salts of glyphosate, including without limitation the mono-iso-propylamine salt of glyphosate, alkanolamine salts of glyphosate, the alkali and/or alkaline earth metal salts of glyphosate, and mixtures comprising any of the foregoing. [0003] In a general sense, it is desirable to provide concentrates which contain one or more salts of glyphosate in as high a concentration as possible because the higher the concentration, the more active ingredient is contained in a given volume, which reduces shipping costs and enables large volumes of final solutions to be prepared from small volumes of concentrate by mere addition of water. Thus, it is desirable to increase the maximum level of glyphosate loading possible to successfully formulate in a commercially-viable product. [0004] One current commercial glyphosate formulation is the mono-iso-propylamine (“IPA”) salt in loaded at 480 g/L active ingredient, which is approximately 360 g/L glyphosate (acid form) equivalent. U.S. Pat. No. 5,668,085 discloses that mono-iso-propylamine glyphosate solutions are easily prepared containing 250-400 g/L of glyphosate acid equivalent. [0005] European Patent EP 1 133 233 B1 (WO 00030452 A1) discloses an adjuvant system compatible with the mono-ethanolamine (“MEA”) salt of glyphosate. Table 1 of this patent shows how the cloud point decreases with increasing surfactant concentration. The patent further states the commonly-held belief that to maintain acceptable cloud point when raising the concentration of glyphosate, the surfactant concentration must be reduced. The cloud point is a measure of the maximum temperature at which a given aqueous composition containing a surfactant and a salt of glyphosate at defined concentrations forms a single-phase solution. Above the cloud point, the surfactant separates from the solution, initially as a hazy or cloudy dispersion, and, upon standing, as a distinct phase generally rising to the surface of the solution. (Cloud point of a composition is normally determined by heating the composition until the solution becomes cloudy, and then allowing the composition to cool, with agitation, while its temperature is continuously monitored. A temperature reading taken when the solution clears is a measure of cloud point.) European Patent EP 0 999 749 B1 discloses high-load ammonium glyphosate. The publications WO 00/30451 and EP1438896A1 disclose compositions containing the MEA salt of glyphosate. [0006] The object of this invention is to provide commercially viable products of very high loaded glyphosate formulations. This invention pertains to IPA salts of glyphosate. BRIEF DESCRIPTION OF THE DRAWINGS [0007] In the annexed drawings, [0008] FIG. 1 graphically depicts the cloud points of solutions containing the mono-iso-propylamine salt and various surfactants and surfactant combinations at a glyphosate loading of 480 grams per liter; [0009] FIG. 2 graphically depicts the cloud points of solutions containing the mono-iso-propylamine salt and various surfactants and surfactant combinations at a glyphosate loading of 580 grams per liter; [0010] FIG. 3 graphically depicts the cloud points of solutions containing the mono-iso-propylamine salt and various surfactants and surfactant combinations at a glyphosate loading of 680 grams per liter; and [0011] FIG. 4 comprises the graphs from FIGS. 1-3 on the same graph. SUMMARY OF THE INVENTION [0012] The present invention provides liquid compositions of matter comprising: a) a glyphosate salt in an amount greater than 480 g/L a.i.; b) a tallowamine alkoxylate; and c) an EDA alkoxylate. [0013] In another embodiment, the present invention provides liquid compositions of matter comprising: a) a glyphosate salt in an amount greater than 580 g/L a.i.; b) a tallowamine alkoxylate; and c) an EDA alkoxylate, wherein the composition has a cloud point greater than 90° C. DETAILED DESCRIPTION OF THE INVENTION [0014] The present disclosure specifies the creation of mixtures comprising ethylenediamine alkoxylates and tallowamine ethoxylates which form stable, homogeneous solutions in combination with the mono-iso-propylamine salt of glyphosate at higher loadings of the glyphosate salt. Example formulations have been made at both 430 g/L glyphosate acid equivalent (“ae”) and 505 g/L glyphosate acid equivalent. The 505 g/L ae formulation enabled observation of two unexpected properties: 1) the cloud point actually increased as the level of glyphosate loading was raised; and 2) a high level of surfactant was maintained at the high glyphosate loading. [0015] According to the work carried out in connection with the present specification, surfactant blends were made using alkoxylates of ethylene diamine (“alkoxylated EDA”) and alkoxylates of tallowamine (“alkoxylated tallowamine”), including those which now follow. The surfactant sold as SURFONIC® ADA-170 surfactant is an alkoxylated ethylenediamine (“EDA”), (propylene oxide (“PO”)/ethylene oxide (“EO”) block) surfactant, and is available from Huntsman LLC of Houston, Tex. The surfactant sold as SURFONIC® R-170 surfactant is an alkoxylated EDA (EO/PO block) surfactant that is also available from Huntsman LLC of Houston, Tex. The surfactant known as SURFONIC® M-170 surfactant is an alkoxylated EDA (EO/PO mixed block) surfactant is also available from Huntsman LLC of Houston, Tex. The surfactant known as SURFONIC® T-15 surfactant is a 15-mole alkoxylated tallowamine (ethylene oxide) that is available from Huntsman LLC. The surfactant known as SURFONIC® T-5 surfactant is a 5-mole alkoxylated tallowamine (ethylene oxide) that is available from Huntsman LLC. The surfactant known as SURFONIC® T-10 surfactant is a 10-mole alkoxylated tallowamine (ethylene oxide) that is available from Huntsman LLC. The glycol sold as POGOL® 400 PEG is a polyethylene glycol with an average molecular weight of about 400 that is also available from Huntsman LLC of Houston, Tex. [0016] It is convenient for this specification and FIGS. 1-4 that the foregoing surfactants be abbreviated as set forth in table I below: [0000] TABLE I abbreviations Surfactant Name Abbreviation SURFONIC ® ADA-170 ADA SURFONIC ® R-170 R SURFONIC ® T-15 T15 SURFONIC ® T-10 T10 SURFONIC ® T-5 T5 SURFONIC ® M-170 M [0017] Nine adjuvant compositions were prepared using the formula in the table II below: [0000] TABLE II formula for adjuvants Component w/w % EDA Alkoxylate 40 Tallowamine ethoxylate 40 POGOL ® 400 PEG 10 H 2 O 10 Total 100 using the three alkoxylated EDA surfactants and the three alkoxylated tallowamine surfactants mentioned above in the combinations specified in Table III below: [0000] TABLE III surfactants used in adjuvants Adjuvant Number Specific Surfactants Used 1 ADA + T15   2  R + T15 3 M + T15 4 ADA + T10   5  R + T10 6 M + T10 7 ADA + T5    8 R + T5  9 M + T5  using the mono-iso-propylamine salt of glyphosate (“IPA glyphosate”) in formulations at three loadings according to table IV below, in which quantities of ingredients are specified in parts by weight: [0000] TABLE IV compositions of finished concentrates Component Normal Load High Load Very High Load IPA glyphosate (62% a.i.) 66.1 78.5 90.0 adjuvant blend 7.5 7.5 10.0 Water 26.4 14.0 — Total: 100 100 100 g/L a.i. (active ingr.) 480 580 680 g/L ae (acid equiv) 360 430 505 S.G. (25/4) 1.17 1.20 1.22 [0018] Cloud point tests were run on the twenty-seven glyphosate formulations so produced using the nine adjuvant formulations for each level of loading specified in table IV, and the results are depicted graphically in FIGS. 1-3 . The cloud point was determined by a three-step procedure of: 1) heating the solution until it becomes cloudy and thence removing the heat source; 2) mechanically stirring the cloudy solution while monitoring its temperature as the sample cools; and 3) recording the temperature at the point at which the solution displays complete clarity. Those of ordinary skill in the art immediately recognize that a cloud point equal or greater than 50° C. is generally required in order for a composition to possess the status of being commercially acceptable. [0000] TABLE V cloud point results for finished concentrates IPA glyphosate loading g/L a.i. 480 580 680 Adjuvant number cloud point (° C.) 1 91 64 55 2 89 65 28 3 86 52 18 4 >100 74 54 5 >100 86 55 6 >100 74 47 7 >100 73 >100 8 >100 94 >100 9 >100 73 >100 [0019] These data are plotted individually in FIGS. 1-3 , and combined in FIG. 4 . All of the 480 and 580 g/L a.i. formulations are homogeneous and have a cloud point greater than 50° C. [0020] The data in Table V and the FIGS. 1-3 show the known trend of increasing cloud point with decreasing moles of ethylene oxide present on the ethoxylated tallowamine surfactant. [0021] However, the compositions according to this invention display results which are wholly unexpected. Firstly, the cloud point increased as the loading was increased from 580 to 680 g/L a.i. IPA glyphosate for the EDA/T-5 adjuvant formulations (adjuvants 7, 8, 9). This is in direct opposition to what one of ordinary skill in the art would expect, as the cloud point normally decreases as glyphosate loading is increased. [0022] Secondly, the cloud point increased as the surfactant concentration was increased. The 580 g/L a.i. formulation contains 7.5 w/w % adjuvant and the 680 g/L a.i. formulation contains 10.0 w/w % adjuvant. This is in direct opposition to what one of ordinary skill in the art would expect, as the cloud point normally decreases as surfactant loading is increased. [0023] Thus, by the present invention, a surfactant system containing IPA glyphosate has been created which can be used to yield formulations containing an ultra-high load of IPA glyphosate, in which the IPA glyphosate concentration is higher than previously possible in any agriculturally-acceptable formulation. With the combinations made using adjuvants numbers 7, 8, and 9, cloud point increased with increased IPA glyphosate loading, instead of trending downward as one of ordinary skill would expect. Thus, according to the present invention, surfactant loading is increased and maintained at the highest IPA glyphosate loading without adversely affecting cloud point. [0024] The three formulations with EDA/T-5 blends (adjuvant numbers 7, 8, 9) were stored for one week at 5° C. in order to determine low-temperature stability. After the expiry of 7 days under such conditions, there was no crystallization present and the solutions had remained homogeneous. Thus, the present invention has provided low temperature-stable, homogeneous formulations of very highly loaded IPA glyphosate, using a range of surfactant blends. The adjuvant chemistry of this invention allows the successful formulation of very high loadings using the IPA salt of glyphosate. [0025] The tallowamine ethoxylate used in the practice of this invention according to one of its preferred forms is a mixture of materials having the general structure: [0000] [0000] wherein R is a mixture of hydrocarbon groups typical of tallow as are well known in the art to comprise alkyl and alkenyl groups having between about 12 and 20 carbon atoms, is mostly C 18 , and in which x and y are each independently any value within the range of between about 1 and about 12, with a value for x and y each of about 2-3 being most preferable. [0026] The alkoxylated EDA component (ADA-170) of a composition according to the invention is a mixture of materials conforming to the general structure: [0000] [0000] wherein EO and PO represent ethylene oxide and propylene oxide units, respectively, and in which a, b, c, d may each independently be any value between about 0 and 3, including 0 and 3, the sum of a+b+c+d has a preferred average value of about 4, but the sum of a+b+c+d may be any value in the range of between about 2 and 8, and in which the sum of p+q+r+s has a preferred average value of about 22 but the average sum of p+q+r+s may be any value in the range of between about 16 and 30. [0027] The alkoxylated EDA component (R-170) of a composition according to another embodiment of the invention is a mixture of materials conforming to the general structure: [0000] [0000] wherein EO and PO represent ethylene oxide and propylene oxide units, respectively, and in which a, b, c, d may each independently be any value between about 0 and 3, including 0 and 3, the sum of a+b+c+d has a preferred average value of about 4, but the sum of a+b+c+d may be any value in the range of between about 2 and 8, and in which the sum of p+q+r+s has a preferred average value of about 22 but the average sum of p+q+r+s may be any value in the range of between about 16 and 30. [0028] The alkoxylated EDA component (M-170) of a composition according to one embodiment of the invention is a mixture of materials conforming to the general structure: [0000] [0000] wherein EO and PO represent ethylene oxide and propylene oxide units, respectively, and in which w, x, y, and z in each occurrence may each independently be any integer between about 0 and 3, including 0 and 3 such that the sum of w+x+y+z is any value in the range of between about 2 and 8; and in which p, q, r, and s in each occurrence may independently be any integer between about 0 and 10, including 0 and 10 such that the sum of p+q+r+s is any value in the range of between about 12 and 24; and in which a, b, c, and d in each occurrence may independently be any integer between about 0 and 3, including 0 and 3 such that the sum of a+b+c+d is any value in the range of about 2 to 8, subject to the proviso that the EO/PO units within the [square brackets] in this equation are added in a random fashion to the EO already connected to the nitrogen atoms, that is, the material is formed by reacting a mixture of the gases EO and PO are with a precursor, which precursor already contains EO attached to the nitrogen atoms in ethylene diamine in an amount as defined by x above. [0029] Thus, the present invention comprises mixtures of two or more alkoxylated nitrogenous substances. It is recognized by those skilled in the art that during the alkoxylation process the alkylene oxide units may add to the nitrogenous substance being alkoxylated in either a random or block fashion. Thus, the compositions of the invention shall not be construed as being limited to any specific structure with regards to which the EO and PO units are present in the molecules, except as otherwise specified herein. It is also recognized that during such alkoxylations used to provide the alkoxylated materials used as components in this invention that a mixture of products are obtained; hence the values of x, y, and z as they represent alkoxide units are average values, as specified. [0030] The present invention also includes compositions containing the molecules as expressed herein in which the propylene oxide is replaced by butylene oxide. The tallowamine may also include propylene oxide units and butylene oxide units. [0031] The present invention also comprises a process for controlling weeds which comprises the step of applying a composition according to the invention to soil and/or foliage. The present invention also comprises a process for controlling weeds which comprises the steps of: 1) diluting any composition according to the invention with any desired amount of water and applying any composition according to the invention to soil and/or foliage. [0032] Consideration must be given to the fact that although this invention has been described and disclosed in relation to certain preferred embodiments, obvious equivalent modifications and alterations thereof will become apparent to one of ordinary skill in this art upon reading and understanding this specification and the claims appended hereto. The present disclosure includes the subject matter defined by any combination of any one of the various claims appended hereto with any one or more of the remaining claims, including the incorporation of the features and/or limitations of any dependent claim, singly or in combination with features and/or limitations of any one or more of the other dependent claims, with features and/or limitations of any one or more of the independent claims, with the remaining dependent claims in their original text being read and applied to any independent claim so modified. This also includes combination of the features and/or limitations of one or more of the independent claims with the features and/or limitations of another independent claim to arrive at a modified independent claim, with the remaining dependent claims in their original text being read and applied to any independent claim so modified. Accordingly, the presently disclosed invention is intended to cover all such modifications and alterations, and is limited only by the scope of the claims which follow, in view of the foregoing and other contents of this specification.

By the present invention, a surfactant system containing glyphosate has been created which can be used to yield formulations containing an ultra-high load of glyphosate, in which the glyphosate concentration is higher than previously possible in any agriculturally-acceptable formulation. Higher loadings are desirable to reduce shipping and container costs, as well as reduce wastes. The higher loading reduces storage requirements and allows the farmer to handle less volume of pesticide. The main advantage is that maximizing the loading minimizes the cost to deliver the active ingredient, which in turn maximizes economy in use of glyphosate.

This invention relates to urea-containing pelletized feeds for ruminant animals and the production of such pelletized feeds. More particularly, this invention is directed to increasing the efficiency of production including the rate of production of such feeds, increasing the nonprotein nitrogen content of such feeds and increasing the nonprotein nitrogen ("NPN") content of such feeds while improving or maintaining the flowability of such feeds when the feeds are subjected to material handling conditions, as when they are subjected to gravitational flow. BACKGROUND A ruminant animal's nutritional requirements generally are provided by forages, grains and other known feed stuffs. Pelleted feed supplements, however, are commonly used to provide nutritional fortification to the diets of ruminant animals, especially beef cattle in feedlots. These feed supplements generally have an organic component and inorganic component, each of which may form about one half, on a weight basis, of the feed supplement. The primary purpose of the feed supplement is to provide the animal with proteins, vitamins and minerals. The inorganic portion of the feed supplement frequently provides the animal with minerals and the organic portion frequently provides the animal with proteins. Ruminant animals have the capability to utilize NPN as a source of protein by virtue of bacterial conversion of NPN to protein in the stomach of the ruminant. NPN is inexpensive relative to using an organic protein source. Urea is commonly used as a source of NPN in pelleted supplements for ruminants. When pelleted supplements containing urea are stored in vertical bins, however, it is often difficult to remove the supplements from the bin via gravitational flow. Urea-containing supplements tend to "hang-up" in the bin rather than flow freely. Precise mechanisms responsible for this problem are not well understood, but may be related to the hygroscopic nature of urea. A broad variety of measures have been used by both supplement manufacturers and supplement users to attempt to overcome this problem. These measures include minimizing steam addition during pelleting, dusting pellets with a fine, dry powder of calcium carbonate and installation of mechanical agitation equipment in the storage bins. Ruminants such as feedlot cattle require a relatively high level of mineral supplementation in their diets. Hence, pelleted supplements tend to contain a high level of inorganic, particulate ingredients such as calcium carbonate and sodium chloride. These particulate inorganic materials constitute substantially all of the inorganic component of the feed and include mineral ingredients. Pelleted supplements also may include particulates such as urea in the organic portion of the feed. The latter mineral and urea particulates are abrasive and cause a high degree of resistance through a pelletization die. This resistance causes wear on manufacturing equipment and relatively poor production rates. It is desirable to provide a method of increasing the efficiency and the rate production of pelletized feeds for ruminant animals, especially feeds which include a large portion of abrasive particulates such as urea and minerals such as calcium carbonate and sodium chloride. It is desirable to provide a pelletized feed with an increased NPN content utilizing urea and a method for providing such a feed with an increased NPN content. It also is desirable to provide a pelletized feed which includes urea and a method for improving the flowability of urea-containing pelletized feed. SUMMARY OF THE INVENTION The invention provides a method for increasing efficiency of production and the rate of the production of pelletized dry feed comprising abrasive particulates such as particulate urea and particulate inorganic materials, such as particulate minerals. In this aspect of the invention, the method comprises mixing aqueous ammonium polyphosphate with a dry feed blend which blend includes the abrasive particulates prior to the pelletization of the dry feed blend. The ammonium polyphosphate is mixed with the blend in an amount effective for providing an increase of the rate of production of pelletized feed at least about 3% relative to the production of a feed containing the same amounts of urea and inorganic materials without using ammonium polyphospate. In an important aspect, the invention is effective for increasing production rate of pelletized feed at least about 3% in a feed which has about from about 35 to about 65 weight percent urea and mineral particulate materials, based upon the weight of a prepelletized feed blend. In another important aspect, the ammonium polyphospate is mixed with the dry feed prior to pelletization such that the prepelletized feed contains at least about 0.3 weight percent ammonium polyphosphate. In another important aspect, sufficient ammonium polyphosphate and urea are mixed with the prepelletized feed to provide at least about 6.4 weight percent NPN in the pelletized feed and the amount of ammonium polyphosphate is effective for providing an increase in the rate of production of at least about 3%. The invention in another aspect also provides a method for increasing the NPN content of a pelletized dry feed by balancing the urea and ammonium polyphospate content of the feed such that the pelletized feed has NPN content of at least about 5.6 weight percent and the pelletized feed of the invention has improved gravitational flowability compared to a pelletized feed without ammonium polyphosphate with the same NPN content. In an important aspect, the method comprises mixing ammonium polyphospate and urea with a feed blend to provide a pelletized dry feed having an NPN content of at least about 6.4 weight percent where the ammonium polyphosphate is in an amount effective for providing the pelletized feed with improved flowability compared to a pelletized feed without ammonium polyphosphate with the same NPN content. In yet another aspect, the invention provides a pelletized dry feed comprising ammonium polyphosphate and urea in amounts effective for providing the pelletized feed with an NPN content of at least about 5.6 weight percent, and in an important aspect at least about 6.4 weight percent, the pelletized feed of the invention having improved gravitational flowability compared to a pelletized feed without ammonium polyphosphate with the same NPN content. In an important aspect the prepelletized feed has at least about 0.6 to about 2.4 weight percent ammonium polyphosphate, based upon the weight of the prepelletized feed blend including ammonium polyphosphate, with the remainder of the NPN being supplied by urea. The invention also contemplates a pelletized dry feed with a high NPN content of at least about 8.0 up to about 11.5 or more weight percent where the prepelletized feed blend comprises urea and at least about 0.6 weight percent ammonium polyphosphate, the urea and ammonium polyphosphate being effective for providing the nonprotein nitrogen content of the feed. Further, the invention provides a method for improving the flowability of a pelletized urea-containing feed, the method comprising adding ammonium polyphosphate into the dry feed prior to pelletization in an amount effective for improving the gravitational flowability of the pelletized feed containing the same relative amount of urea, but without ammonium polyphosphate. DESCRIPTION OF THE PREFERRED EMBODIMENTS Definitions Percentage of NPN means percentage of nonprotein nitrogen and is related to protein equivalents in that approximately 16.0 weight percent of protein is nitrogen. Hence, to get the protein equivalents from the weight percent NPN, multiply weight percent NPN by 6.25. Conversely, if the protein equivalent number is 40, the NPN weight percent is obtained by dividing 40 by 6.25 to indicate a NPN weight percent of 6.4. Flowability means flowability under field material handling conditions using gravity. In the field, feed is moved from container to container using gravity. Hence, material handling using the invention and gravity to move pelletized feed is compared to material handling using gravity without the invention. The percentage of ingredients in the prepelletized feed blend and the pelletized feed are assumed to be about the same. For clarity and consistency with the examples, this specification will sometimes refer to a weight percent based upon the weight of the prepelletized feed, but this percentage should be the same or very close to the percentage amount for the same ingredient in the pelletized feed. Preferred Embodiments This invention has several aspects. The pelletized dry feed supplement has an organic portion and an inorganic portion. The pelletized dry feed supplement is made by mixing aqueous ammonium polyphosphate and a dry feed blend which includes feed grade urea. Prior to the mixing of aqueous ammonium polyphosphate, the dry feed blend generally does not have more than about 15 weight percent moisture, and preferably does not have more than about 10 to 13 weight percent moisture, based upon the weight of the "dry" feed. Generally the feed blend has from about 35 to about 65 weight percent abrasive particulates which include urea and a particulate mineral portion. These particulates make pelletization through a pelletization die difficult. In one aspect of the invention aqueous ammonium polyphospate is mixed into the dry feed blend in amount sufficient to provide a prepelletized feed blend with at least about 0.3 weight percent ammonium polyphosphate based upon the weight of the feed blend which includes the ammonium polyphosphate to increase the rate of production of pelletized feed at least 3%. The amount of ammonium polyphosphate mixed with the feed blend is a function of the ingredients in the blend, especially the amount of particulate inorganic minerals and urea in the blend. The particle size of these abrasive particles vary from powder up to about 1000 microns. Because these materials tend to make extrusion of the pellets difficult, sufficient ammonium polyphosphate should be added to the dry feed blend in an amount effective for increasing the rate of production at least 3%. In an important aspect, sufficient aqueous ammonium polyphosphate is mixed into the feed blend to provide the prepelletized feed blend with from about 0.6 to about 2.4 weight percent ammonium polyphosphate, based upon the total weight of the feed blend, including the aqueous ammonium polyphosphate. This is to provide an increase in the rate of production of the pelletized feed, even with prepelletized feed blends having a abrasive particulate contents as high as 65 weight percent, based upon the total weight of the feed blend including the aqueous ammonium polyphosphate. The dry feed blend has an organic portion which includes: 1. Grains and grain byproducts such as corn, sorghum, wheat, grain screenings, wheat middling, distillers grains, rice bran, and corn gluten feed; 2. Urea as a NPN source; 3. Plant protein products, such as soybean meal, cottonseed meal, sunflower meal, peanut meal, and corn gluten meal; 4. Animal protein products, such as meat and bone meal, blood meal, and feather meal; 5. Roughage products, such as oat hulls, cottonseed hulls and soybean hulls; 6. Animal fat; 7. Vegetable oils; and 8. Vitamin supplements. The dry feed also has an inorganic portion, such as calcium carbonate, magnesium carbonate, potassium chloride, copper sulfate, zinc oxide, zinc sulfate, copper chloride, iron oxide, iron sulfate, manganous oxide, cobalt carbonate, ammonium sulfate, calcium sulfate, monocalcium phosphate, dicalcium phosphate, sodium chloride, and magnesium oxide. To build NPN content, the feed prepelletized blend will have at least one weight percent feed grade urea up to about 20 weight percent urea based upon the weight of the blend which includes ammonium polyphosphate. Ammonium polyphosphate and urea may be balanced in the feed, as will be discussed to provide an NPN content in the pelletized feed as high as 8 to 11.5 weight percent and above. In another aspect the invention provides a method for increasing the NPN of a pelletized dry feed by balancing the urea and ammonium polyphospate content of the feed such that the NPN content of the pelletized feed is at least about 5.6 weight percent and the pelletized feed of the invention has improved gravitational flowability compared to a pelletized feed without ammonium polyphosphate with the same NPN content. In an important aspect, the method comprises mixing ammonium polyphospate and urea into a dry feed to provide a pelletized dry feed having an NPN content of at least 6.4 weight percent where the ammonium polyphosphate is in an amount effective for providing the pelletized feed with improved gravitational flowability compared to a pelletized feed without ammonium polyphosphate with the same NPN content. In this aspect of the invention the amount of aqueous ammonium polyphosphate mixed with the dry feed blend is an amount effective to provide the feed blend with at least about 0.6 weight percent ammonium polyphosphate, based upon the weight of the prepelletized feed blend including ammonium polyphosphate. In an important aspect the prepelletized feed blend will have at least about 2.0 weight percent ammonium polyphosphate and at least about 11 weight percent urea to provide an NPN content of the pelletized feed of about 6.4 weight percent. The pelletized feed blend is made by mixing the organic portion and inorganic portion including the urea and particulate minerals in a ribbon mixer to achieve homogeneous mixing such as after about one minute in a ribbon mixer. Thereafter the ammonium polyphosphate is sprayed into the blend as an aqueous solution which is commercially available as a solution with 59 weight percent ammonium phosphate and 41 weight percent water. Thereafter, the blend which includes the ammonium polyphosphate is mixed for about 3 to about 5 minutes and is conveyed to a conditioning chamber where steam is introduced into the chamber to achieve a feed or meal conditioning temperature of from about 100 to about 130° F. The temperature of the feed at the die should not exceed about 160° F. Then, the warmed feed is dropped into a pelletizing die and formed into pellets. Thereafter, the warm pellets drop directly from the pelletmill into a cooler and are cooled using ambient air to within 10 degrees Fahrenheit of ambient temperature. The cooled pellets are then discharged and conveyed to a storage bin for eventual use. The pelletization die usually is a cylinder with a plurality of holes in its curved walls with one or more rollers pushing the feed through the holes in the curved walls. A blade nips the pellets as they exit the holes. A fuller description of known pelletization equipment appears in Feed Manufacturing Technology, American Feed Industry Association, Inc., Arlington, Va., Vol. IV 1994, Ch. 10, pp. 111-130, which is rewritten herein. The following examples illustrate how to practice the invention and make the pelletized feed of the invention. EXAMPLE 1 A nutrient constant formula and a standardized formula as shown below are pelletized according to the following procedure. Production data also is shown below. This data shows the significance of the presence of ammonium polyphosphate increasing the production of pelletized urea-containing feed supplement. The formulations were pelletized as follows: 1.) Mixing-- Scott Ribbon Mixer--1/4 Ton Ingredients of each formula are hand scaled into weigh buggy and transferred to the mixer by elevator leg. The ammonium polyphosphate is sprayed onto the feed and the feed is mixed for five minutes. 2.) The mixed feed is conveyed by gravity into elevator leg and transferred to the pelletmill hopper. 3.) Pelletmill-- California Pelletmill--Century Model--50 HP The pelletmill feeder meters the feed into the conditioner. The feed is mixed with steam to achieve the conditioning temperature. The warm feed falls out of the conditioner into the die chamber and is formed into pellets. The pelletmill die is 16 inch diameter, 10/64 pellet hole diameter, with a 2 inch effective thickness, 1/4 inch variable relief. 4.) Cooling--The pellets are transferred by a belt conveyor into a Wenger single pass horizontal cooler. The pellets are cooled by ambient air to within 10 deg F. of the ambient air temperature. The cooled pellets are belt conveyed to the bagging bin. EXAMPLE 1 ______________________________________ Nutrient-Constant Standardized Formula Formula Control APP** Control APP______________________________________Formulations Evaluated*Corn 18.05 15.55Wheat midds 60.79 61.54 61.38 61.38Soybean meal 3.53Urea 10 10 10 10Salt 6.25 6.75 6.75 6.75Calcium carbonate 15.51 16.84Potassium chloride 2.11 2.22 2.13 2.13Mono-dicalcium phosphate 1.81 0.15 1.69 1.69Ammonium polyphosphate 2.5 2.5Total 100 100 100 100Nutrient levelsProtein 41 41 41 42.34Crude fiber 5.54 5.32 5.69 5.63Crude fat 0.45 2.43 3.15 3.05Calcium 6.5 6.75 0.39 0.41Phosphorus 1 1 1 1.36NPN 4.6 4.85 4.6 4.85Production DataBatch size, lb 500 500 500 500Runtime, min 13.58 12.25 12.25 11.75Tons/hr 1.1 1.22 1.22 1.28Production temperatures***Meal 55 60 60 60Conditioned 115 113 120 114Hot pellet 160 163 159 145Die change 45 50 39 31Cool pellet 96 96 72 74Production dry mattersMeal 91 87.55 86.57 86.49Conditioned 87.5 86.93 84.72 83.82Cool pellet 89.88 90.04 87.28 86.77PDI**** 98.4 98.6 98 97.8Density 36.9 36.5 35.55 35.05______________________________________ *Formulations are weight percent **APP is ammonium polyphosphate with the percentage of ammonium polyphospate being the percent of a solution comprising 59 weight percent ammonium polyphosphate and 41 weight percent water. ***Degrees F ****Pellet Durability Index EXAMPLE 2 The ingredients listed in Table A are conveyed from storage bins into a scale hopper located directly above a Hayes and Stoltz three ton ribbon mixer. The ingredients are individually weighed in the scale hopper to provide the weight percentages listed in Table A and are allowed to fall by gravity into the mixer. The dry ingredients are mixed for about 30 seconds to one minute, the ammonium polyphosphate is sprayed thereon and mixing is continued for 3-5 minutes to form a uniform blend. The uniform blend is placed in a surge hopper and then is conveyed to a pellet mill hopper. The uniform blend was metered from the pellet mill hopper into the conditioning chamber of a 250 horsepower California Pelletmill. Steam is introduced into the chamber to achieve a meal conditioning temperature of from about 100 to 130° F. This warmed meal was dropped into the die and formed into pellets. The warm pellets drop directly from the pelletmill through an airlock into the California Pelletmill Cooler (Model 2400×2400) and are cooled using ambient air to within 10 degrees Fahrenheit of ambient temperature. Pellets are discharged when cooled and are transferred by elevator into a storage bin for eventual use. The pellets made according to the above procedure are gravitationally flowable. TABLE A______________________________________Ingredients % Used______________________________________Feather meal 12.000Distillers grains 12.500Urea 11.94Salt 3.93Calcium carbonate 17.270Potassium chloride 50 5.84Sunflower meat 6.77Mono-dicalcium phosphate 1.55Ammonium polyphosphate 2.000Ammonium sulfate 5.000Zinc sulfate 0.096Mineral ad 3.000Trace mineral Premix 0.250Peanut meal 17.55Total 100.000______________________________________ TABLE B______________________________________ Nutrient Levels Amount______________________________________ Protein % 67.000 Fat % 2.25 Calcium % 7.850 Phosphorus % 0.930 Magnesium % 0.75 NPN % 6.7 Sulfur % 1.500 Potassium % 3.26 Dry matter % 94.63______________________________________ EXAMPLE 3 The ingredients in Table A below were pelletized as described in example 2 and provided a flowable pelletized product. ______________________________________Ingredients % Used______________________________________Rice bran - high fat 9.000Distillers grains 5.000Urea 22.950Salt 4.100Potassium chloride 50 1.15Sunflower meal 5.85Mag ox 54 1.88Mono-dicalcium phosphate 0.310Ammonium polyphosphate 1.000Ammonium sulfate 1.500Copper sulfate 0.050Trace mineral premix 1.52Peanut meal 21.89Calcium carbonate 23.81Total 100.000______________________________________Nutrient Levels Amount______________________________________Protein % 84.000Fat % 2.46Calcium % 9.600Phosphorus % 0.600Iodine MG/KG 12.62Manganese MG/KG 1,367.79Salt % 4.000Zinc MG/K 2529.880Copper MG/K 519.87Iron MG/K 94.84Magnesium % 1.500Cobalt MG/K 3.79NPN % 10.88Sulfur % 0.436Potassium % 1.000Dry matter % 95.66Sodium % 1.68Add Vit. A KIU/LB 0.000Add Vit. E LB 0.000______________________________________

This invention is directed to increasing the efficiency of production including the rate of production of urea-containing pelletized feeds, increasing the nonprotein nitrogen content of such feeds and increasing the nonprotein nitrogen ("NPN") content of such feeds while improving or maintaining the gravitational flowability of such feeds when the feeds are subjected to material handling conditions, as when they are subjected to gravitational flow.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 60/561,177, filed Apr. 8, 2004, and U.S. Provisional Application No. 60/604,399, filed Aug. 24, 2004, the entire contents of both Provisional Applications being incorporated by reference herein. STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT [0002] (Not Applicable) BACKGROUND OF THE INVENTION [0003] The present invention relates generally to food preparation and, more particularly, to an improved method for rapidly preparing authentic refried beans produced from dehydrated starting material. [0004] The Mexican phrase “frijoles refritos” is commonly mistranslated as “refried beans”, i.e. beans twice fried. The true meaning of the phrase is “well fried” or “really fried” beans. Authentic frijoles refritos made from scratch require a lengthy process. The process includes sorting and washing raw beans to remove foreign material before soaking the beans in water overnight after which the beans are simmered for most of the day until soft. When cooked, some beans may be served as whole beans while they are still hot. The remainder of the beans may be held over for frying the next day or they may be fried while still hot. Traditional frijoles refritos are mashed and fried. Importantly, the act of frying facilitates browning which develops the distinctly authentic flavor of true frijoles refritos. [0005] Refried beans are enormously popular as a dish in Mexican style cooking. In both residential (i.e., home) and institutional (i.e., restaurant) applications, Mexican foods have become one of the fastest growing food staples in the food market. Prepared products such as canned refried beans and dehydrated refried beans have helped to popularize them by alleviating the lengthy traditional preparation process. However the Mexican segment of the market, with its cultured and discriminating taste, prefers the traditional refried beans. [0006] Canned “refried beans” were the first ready-to-heat and eat refried beans on the market. Examples of today's offerings of canned refried beans are Goyo™ “PINTO BEANS”, Rosarita™ “TRADITIONAL REFRIED BEANS” (No Fat), Ducal™ “REFRIED BLACK BEANS”, Rosarita™ “GREEN CHILE AND LIME REFRIED BEANS”, Knorr™ “REFRIED BLACK BEANS”, Rosarita™ “BLACK REFRIED BEANS”, Ortega™ “FAT FREE REFRIED BEANS” and Rosarita™ “TRADITIONAL REFRIED BEANS”. [0007] Typical heating directions for canned refried beans include stove top preparation and microwave preparation. The stovetop preparation directions are very simple: “Heat in a saucepan over medium heat until hot”. The microwave preparation directions are slightly more complex: “Heat in a covered microwave-safe dish on high for 4 to 6 minutes, or until hot. Stir once during cooking time.” Notably, canned refried beans are not fried at all. Typical ingredients of canned refried beans include cooked beans, water, lard, salt, chili pepper, distilled vinegar, onion powder, spices, garlic powder and natural flavor. Furthermore, canned refried beans not only lack the traditionally fried product flavor quality but they also have an undesirable canned flavor. [0008] In light of the above described deficiencies associated with refried beans that are provided in cans, various manufactures have, during the past twenty years, began producing dehydrated bean products that, to a certain extent, have overcome some of the problems associated with canned refried beans such as heavy shipping weight as well as the problem of disposing of empty cans. Additional deficiencies associated with canned refried beans, not exclusive to the above-mentioned flavor problems, are resolved. [0009] U.S. Pat. No. 4,871,567 issued to Sterner et al. discloses a method of preparing a reconstitutable refried bean product which contains a quantity of whole beans as well as a quantity of crushed or mashed beans. The method disclosed in the '567 reference includes the steps of inspecting, destoning, cleaning and washing the whole beans. The method further includes the steps of tempering the whole beans for a predetermined period of time after which the whole beans are divided into two sub-quantities, one of which is destined to be crushed or mashed and the other which remains whole, and the steps of cooking, dehydrating, adding secondary ingredients, and packaging, in order to provide an easily reconstitutable refried bean product having both whole and crushed beans. [0010] U.S. Pat. No. 4,735,816 represents a further example of a process for producing dehydrated refried bean products that can be reconstituted upon subsequent hydration. The '816 patent discloses a process for producing dried beans to form an instantly reconstitutable product. The process of the '816 patent discloses the steps of cooking the beans in a manner wherein the skin remains generally intact and wherein the cooked beans are subsequently pressed in order to minimize grittiness and graininess. The pressed beans are of sufficient thickness to allow rapid dehydration and rapid reconstitution or rehydration to provide a reconstituted bean product that has the characteristics similar to those of conventional prepared non-dehydrated beans. [0011] U.S. Pat. No. 5,980,971 discloses a process for producing a dehydrated refried bean product that can be reconstituted upon subsequent hydration. The process disclosed in the '971 reference is directed towards the production of dehydrated bean flakes and whole beans that allegedly have the appearance and texture of canned or conventionally prepared Mexican style refried beans when reconstituted. The process involves the steps of cleaning, sorting and washing. The beans are either milled by dry grinding or wet milling. The bean mixture or slurry is cooked and dried by a continuous method. Another embodiment is the production of dehydrated whole beans. Whole beans are cooked by conventional methods without pre-cooking or soaking after being sorted, cleaned, and washed. After cooking the whole beans, beans which are no longer intact and now are in the form of a slurry are separated from the intact beans. The whole beans are dried in a manner which does not disrupt their intact structure. The cooked bean slurry is dehydrated to form a flake and/or a powder. [0012] An even further example of an attempt by various manufactures to produce dehydrated refried bean product that can be reconstituted upon subsequent hydration includes that which is disclosed by U.S. Pat. No. 5,744,188. The method disclosed in the '188 reference includes the steps of hydrating raw beans by first treating them with an alkaline solution to raise their Ph level as well as raise the moisture content thereof. The '188 reference then includes the steps of neutralizing the raw product with an acidic solution while raising the moisture content. The hydrated bean product is then cooked and dehydrated to produce a product having the taste and appearance of freshly prepared bean product. [0013] An even further attempt at producing dehydrated refried bean product that can be reconstituted upon subsequent hydration is that which is disclosed in U.S. Pat. No. 4,676,990 issued to Huffman et al. The method disclosed in the '990 reference includes the steps of hydrating the beans and cooking such beans to form a mash prior to forming the resultant mixture into shapes suitable for dehydration to a storage-stable moisture content. The dehydrated density ratio and rehydration ratio allow for substantial reconstitution while not requiring agitation thereof. [0014] U.S. Pat. No. 4,407,840 discloses a process for producing dried refried bean powder which is instantly reconstitutable with water to form a product that allegedly has flavor, color and texture that is consistent with conventionally produced refried beans. The process disclosed in the '840 reference includes the steps of immersing raw beans in hot water to hydrate the beans followed by pressure cooking the beans in a suitable pressure cooker. Upon completion of cooking, the beans and water, which are under relatively high pressures and temperatures in the pressure cooker, are discharged from the cooker in an almost instantaneous manner. This instantaneous release of pressure on the cooked beans result in substantial physical degradation of the beans, thereby forming a bean slurry containing finely divided bean mash, whole bean, pieces and bean skin particles. The slurry may then be milled through a screen having a relatively coarse sieve opening, with minimal grinding action, to reduce the whole bean pieces to a relatively small particle size while the bean skin particles are retained. The milled slurry is then dried, such as by applying the slurry to a single or double drum dryer, to a maximum moisture content of about 6%. [0015] A still further prior art attempt at producing dehydrated refried bean product that can be reconstituted upon subsequent hydration is disclosed in U.S. Patent Application No. 2002/136811. The steps disclosed in the '811 reference includes adding organic acid to water in order to condition the beans during hydration. The '811 reference further includes the steps of cooking the conditioned beans in a pressure vessel followed by decompressing the cooked beans in a hydrostatic loop further followed by dehydrating the decompressed beans to form reconstitutable bean product. [0016] U.S. Pat. No. 6,842,457 discloses yet another method of producing a dehydrated food product directed toward conventionally prepared refried beans. The method uses a special conditioning and cooking apparatus which produces a mixture of cooked whole beans and bean pieces which are spread out in a flat sheet and baked. The baked cake is then broken into chunks. [0017] Likewise U.S. Patent Application No. 2003/068417 discloses a method of preparing reconstitutable, dehydrated refried bean product including the steps of using a microwave/convection oven to dry the cooked beans in such a way as to preserve the integrity of the beans and enhance the texture and quality thereof. The process disclosed under the '417 reference is indicated as reducing the amount of time to produce the reconstitutable, dehydrated bean product as well as reducing the tendency for the beans thereof to adopt a “bird mouthing” configuration prevalent in existing methods for producing such bean product. [0018] The above referenced prior art is directed toward eliminating the lengthy and laborious process that is required to make traditional refried beans from scratch at the point of use, and, in the case of these dehydrated products, addressing the various problems associated with canned refried beans such as flavor problems, high cost of shipping and problems associated with disposal of used containers of refried beans. Notably, some of the above referenced prior art processes have enjoyed commercial success. More specifically, dehydrated refried beans made by the processes described in Patent Nos.: U.S. Pat. No. 4,676,990, U.S. Pat. No. 4,735,816 and U.S. Pat. No. 4,871,567 have enjoyed commercial success in that such processes have been employed in the annual production of the multi-millions of pounds of refried beans by such popular restaurants as Taco Bell, Inc. [0019] Nevertheless, there remains a need in the art for a refried bean that incorporates all the benefits of the available dehydrated refried beans, and which additionally has the preferred flavor and texture of frijoles refritos (i.e., “beans really fried”) such as those which are made from scratch in a Mexican home. The failure of all prior art attempts to produce a canned or dehydrated refried bean with true authentic frijoles refritos flavor is due to the failure in the prior art to include a frying step in the process. Without frying, the beans do not brown during preparation and browning enhances and intensifies the flavor of the refried beans. The prior art dehydrated refried beans are only cooked in water and are reconstituted with hot water, by simmering in hot water, by microwave cooking in the presence of water or, in the case of canned refried beans, by simply heating in a sauce pan or in a microwave oven. SUMMARY OF THE INVENTION [0020] Provided is a traditional refried bean product starting with cooked and dehydrated bean material. Also provided is a method or process for rapidly preparing authentic refried beans produced from dehydrated starting material. The cooked and dehydrated bean material is fried and browned on a heated cooking surface while being reconstituted with water, simultaneously developing a rich, authentic Mexican refried bean flavor. Advantageously, the process described herein provides a method for producing authentic Mexican refried beans in a significantly reduced amount of time over the lengthy traditional method of preparing refried beans. [0021] It is contemplated that the heated cooking surface such as the frying pan may be coated with cooking oil and it may also contain ingredients for sauteing. For example, such ingredients may include meat, vegetables, spices and various seasonings and materials. Illustrative examples of ingredients that may be added include onions, onion powder, garlic, garlic powder, chilies, chili powder, pepper, salt, chorizo, and bacon as well as any other desirable ingredient. The particular oil that may be used includes oil from animal fat or vegetable oil according to the preference of the preparer. [0022] Regarding the nature of the dehydrated bean product that may be used, it is contemplated that dehydrated beans can be of any variety of commercially available offerings and preferably be in a flake form. The heated cooking surface is preferably a frying pan or a skillet although any cooking surface for frying may be suitable for the above described process. It is contemplated that in certain embodiments, the heated cooking surface may be of the non-stick variety such as Teflon. It is also contemplated that oil may be excluded prior to adding dehydrated bean material and water to the heated cooking surface. In such instance, the water and bean mixture are simmered and browned in the same manner as in the case where oil is added to the heated cooking surface. It is also contemplated that the process may include the use of a spatula or other stirring or mixing device which may be utilized to perform the stirring action in order to mix the water with the dehydrated bean product and oil and other ingredients into the desired consistency. [0023] Importantly, this invention teaches a method of frying a mixture of a dehydrated bean product with water and, when desired, lard or vegetable fat to produce an authentic fried bean flavor as is traditionally known. Moreover, because the above referenced prior art does teach reconstituting the dehydrated refried beans with water and does not teach or mention the act of frying anywhere in the manufacturing process or in the directions for use, that such products of the prior art lack the authentic Mexican fried and browned flavor which is preferred by North and Central American refried bean consumers. Furthermore, the process disclosed herein results in an authentic Mexican refried bean which additionally has the texture and color of refried beans that are prepared from scratch. [0024] The process described herein results in an authentic traditional refried bean product starting with cooked dehydrated starting material. The benefits of using such process include considerable time savings compared to the time required to prepare the refried beans starting from scratch with raw beans. For example, in order to clean, soak and cook raw beans in a home setting requires a span of about 18 hours or more to prepare the beans for frying whereas dehydrated bean material is ready to fry immediately after purchasing. [0025] Advantageously, the process for producing traditional refried beans from dehydrated starting material takes much less time than traditional methods of producing refried beans. It is estimated that the preparation of a desired product may require as little as three minutes depending on the nature of the starting dehydrated product (e.g., whether low density flake beans are used.) Importantly, producing refried beans under the disclosed process results in a superior product with exceptional taste, texture and color. A further advantage of using this invention is that browning can be achieved by using the frying capabilities of the heated cooking surface such as a frying pan. Such browning increases the depth and concentration of flavors throughout the refried bean product thereby improving the overall quality of the refried beans. [0026] In one aspect of the invention, a heated cooking surface, such as a frying pan, is heated, such as on a stove. The heated cooking surface is preferably raised to a relatively high temperature. Fat or oil may optionally be added to the heated cooking surface such as by distributing the oil or fat over the heated cooking surface. Dehydrated bean products may then be added to the heated cooking surface. If oil is added to the heated cooking surface, the oil may cover at least a portion of the heated cooking surface and/or frying pan. Water may then be added to the heated cooking surface. However, it is preferable that the water is not added directly to the heated oil, but is added only after the bean flakes and/or powder have been added to the oil on the heated cooking surface and/or in the frying pan. Notably, in the presence of dehydrated bean products, water does not cause the oil to splatter out of the heated cooking surface or frying pan which increases the safety and overall sanitation of the process. [0027] Regarding the temperature at which the heated cooking surface should be heated prior to introduction of the bean product or prior to frying of the bean product/water/oil combination, it is estimated that the oil and/or the heated cooking surface is preferably at a temperature greater than 250° F. and preferably between 325° F. and 350° F. in the cooking step. Regarding proportions with which the ingredients may be added, in certain embodiments, such as low density flakes from Inland Empire Foods, Inc., the dehydrated bean product and water may be added in equal or roughly equal portions. [0028] In some embodiments, it is contemplated that water in the mixture may evaporate through prolonged stirring and heating such that the bean mixture or slurry achieves a thicker (i.e., less soupy) consistency. It is estimated that in preferred embodiments of the above described process, the method takes between about 2½ minutes to about 4 minutes. However, in situations where refried bean product is derived from a starting material of whole beans, a matrix of bean pieces and whole beans, and baked chunks, the process may consume longer periods of time such as on the order of about 3 to about 40 minutes. In such instances, a higher ratio of water to beans may be required. When using these higher density dehydrated beans, the water ratio required may be three volumes of water to each volume of dehydrated bean product. [0029] In a further aspect of the invention, the refried bean product may be produced according to any of the preceding described methods or processes. It is also noted that any of the preceding embodiments or processes disclosed herein can be combined to produce the end result. In certain preferred embodiments, the product will result in a bean cake not unlike a breakfast pancake. In other embodiments it may be a loose bean paste. In still other embodiments it may be substantially whole beans. However, it is contemplated that the end product may be a combination of the above cake, paste and/or whole bean forms. In this regard, it is contemplated that the end product may be provided in any size, shape or configuration suitable for the application. DETAILED DESCRIPTION OF THE INVENTION [0030] Provided is a unique method for producing refried beans from dehydrated starting material such as dehydrated beans flakes. The dehydrated beans may also be provided in bean powder form, in a combination of bean flakes and whole beans, in the form of whole beans only. Furthermore, the dehydrated beans may also be provided in the form of a bean matrix including flat and round shaped beans or in a bean matrix of bean pieces and whole beans. It should be noted that the dehydrated beans may be made from cultivars such as phaseolus vulgaris. In addition, the dehydrated beans may contain a component of animal fat or vegetable oil and/or at least one seasoning. Such seasoning may include salt, onion, garlic, chili pepper and spice, either individually or in various combinations thereof. Other seasonings may be added as well. [0031] Low density or high density bean flakes such as that which is available from Inland Empire Foods of Riverside, Calif. is a preferred starting material. In the process, dehydrated beans are added to a heated cooking surface which is preferably at a temperature above about 250° F. and, more preferably, may be in the range of from about 325° F. to about 350° F. [0032] Oil may optionally be added to a heated cooking surface such that the heated cooking surface is at least partially covered with the oil. Thereafter, dehydrated beans such as in the bean flake form may be added to the heated cooking surface. However, the dehydrated beans may be added to the heated cooking surface with no oil being added thereto. Water may then be added to the dehydrated beans on the heated cooking surface to form a bean mixture or slurry. The bean mixture or slurry is stirred to facilitate rehydration and/or evaporation until the bean mixture achieves the desired browning and consistency. [0033] The dehydrated beans and the water may be added in substantially equal volumetric proportions. It is also contemplated that the volumetric ratio of water to dehydrated refried beans may also be in the range of from about 1:1 to about 3:1. However, it is contemplated that the dehydrated beans and the water may be added in any ratio. [0034] It should be noted that the above described sequence or steps may be varied in any format, e.g., by adding water, then beans, then oil, or by adding oil, then beans, then water, or by adding beans, then water, then oil, etc. As was earlier mentioned, the above steps can be performed without including the oil. Ingredients such as meat, vegetables, seasonings, and spices may be added to the heated cooking surface. Furthermore, such ingredients may be sauteed in oil on the heated cooking surface. It is also contemplated that such ingredients may be removed from the oil prior to adding the dehydrated beans such that the ingredient flavor is imparted to the oil. [0035] As can be seen, the particular order of steps for producing the refried beans is not important. Toward this end, any sequence of steps listed in the claims is not to be interpreted as sequence limiting of the claims unless specifically stated in the claims as such. It is contemplated that the preparation time is generally from about 3 minutes to about 40 minutes. For the case wherein the dehydrated refried beans are in bean flake form, it is contemplated that the preparation time is in the range of from about 3 minutes to about 5 minutes. For the case where the dehydrated beans are in extruded form, the preparation time is contemplated to be in the range of from about 15 minutes to about 40 minutes. For the case where the dehydrated beans are in the form of the bean matrix of bean pieces and whole beans, the preparation time is contemplated to be in the range of from about 5 minutes to about 30 minutes. [0036] In the first embodiment herein, the dehydrated bean starting material has not been previously rehydrated and is placed directly on the heated cooking surface. As was earlier mentioned, oil in the form of vegetable oil, animal fat may optionally be added to the heated cooking surface. Water may then be added to the dehydrated bean such as by pouring over the beans on the heated cooking surface. The resulting bean mixture or slurry may be stirred until the bean material begins to pull away from, and begin to brown on, the heated cooking surface. At this point, the refried beans are ready to serve. This whole process takes approximately three minutes if the dehydrated beans are of the flake type available from Inland Empire Foods of Riverside, Calif. These flakes are produced pursuant to that which is disclosed in letter Patent No. U.S. Pat. No. 4,735,816, the entire contents of which are herein incorporated by reference. [0037] The texture of the end product of the invention is influenced by the form of the starting dehydrated bean material. A smooth bean paste is achieved by using dehydrated bean in bean powder or bean flour as the starting material. The end product may result in a bean cake similar to a breakfast pancake. However, the end product may be a matrix of the bean cake, bean paste and/or whole bean forms and may be result in any size, shape or configuration suitable for the application. A chunky texture may be achieved by using a mixture of dehydrated bean flake and dehydrated whole beans as is disclosed in letter Patent No. U.S. Pat. No. 4,871,567 and available from Inland Empire Foods of Riverside, Calif. The '567 patent is herein incorporated in its entirety by reference. The references cited here above and below are examples only and are not meant to be limiting. [0038] Described below are specific examples that are illustrative of the various processes that may be used in this invention. Such examples are illustrative only and are not intended to be limiting of the broad scope and spirit of the invention. EXAMPLE 1 Preparation Instructions [0039] 1. Heat a cooking surface such as a frying pan, griddle or skillet (preferably having a non-sticking surface) on high heat. [0040] 2. Add 1 tablespoon of vegetable oil or animal fat. [0041] 3. Add 1 heaping cup of Inland Empire Foods dehydrated beans prepared essentially as described in commonly-owned U.S. Pat. No. 4,871,567 and U.S. Pat. No. 4,735,816. [0042] 4. Add 1 Cup of water. 5. Using a spatula, stir the bean mixture and fry until desired consistency is achieved while simultaneously browning at least a portion of the bean mixture. If thinner consistency is desired, add more water or fry for a shorter period of time after browning. If thicker consistency is desired, add less water or stir for a longer period of time to evaporate more water after browning. EXAMPLE 2 Preparation Instructions—Without Oil [0044] 1. Heat a cooking surface on high heat. 2. Omit step 2 of Example 1. 3. Add 1 heaping cup of Inland Empire Foods dehydrated beans prepared essentially as described in commonly-owned U.S. Pat. No. 4,871,567 and U.S. Pat. No. 4,735,816. 4. Add 1 cup of water to the dehydrated beans on the heated cooking surface to heat the mixture of beans and water. 5. Using a spatula, stir the bean mixture and fry until desired consistency is achieved while simultaneously browning at least a portion of the bean mixture. If thinner consistency is desired, add more water or fry for a shorter period of time after browning. If thicker consistency is desired, add less water or stir for a longer period of time to evaporate more water after browning. EXAMPLE 3 Preparation Instructions—By Weight [0000] 1. Heat a cooking surface on high heat. 2. Add 14 grams of vegetable oil or animal fat and heat the oil to approximately 325° to 350° F. 3. Add 127 grams of Inland Empire Foods dehydrated beans. 4. Add 118.5 grams of water to the beans. 5. Using a spatula, stir the bean mixture and fry until desired consistency is achieved while simultaneously browning at least a portion of the bean mixture. If thinner consistency is desired, add more water or fry for a shorter period of time after browning. If thicker consistency is desired, add less water or stir for a longer period of time to evaporate more water after browning. EXAMPLE 4 Preparation Instructions—With Sauteed Ingredients [0000] 1. Heat a skillet or frying pan, either nonstick or conventional, on high heat. 2. Add 1 tablespoon of vegetable oil or animal fat. Heat the oil to approximately 325° F. to 350° F. 3. Add desired suggested ingredients for sauteing. Suggested ingredients include, e.g., green onions, garlic or onion. 4. Add 1 cup of Inland Empire Foods Dehydrated beans. 5. Add 1 cup of water. 6. Using a spatula, stir the bean mixture and fry until desired consistency is achieved while simultaneously browning at least a portion of the bean mixture. If thinner consistency is desired, add more water or fry for a shorter period of time after browning. If thicker consistency is desired, add less water or stir for a longer period of time to evaporate more water after browning. The following ranges of ingredients may be used in any or all of the above described examples for preparing refried bean from dehydrated starting material (i.e., bean flakes). EXAMPLE 5 Ingredients List—Using Inland Empire Foods Low Density Bean Flakes [0000] 1. ⅛ cup vegetable oil or animal fat 2. ¼ cup onions, diced 3. 2 cups bean flakes (94 g) 4. 1¼ cups water EXAMPLE 6 Ingredients List—Using Inland Empire Foods High Density Bean Flakes [0000] 1. ⅛ cup vegetable oil or animal fat 2. ¼ cup onions, diced 3. 1 cup bean flakes (80 g) 4. 1 cups water EXAMPLE 7 Ingredients List—Using Basic American Foods Bean Ribbons [0000] 1. ⅛ cup vegetable oil or animal fat 2. ¼ cup onions, diced 3. 1 cup bean ribbons (125 g) prepared essentially as described in U.S. Pat. No. 4,676,990. 4. 1½ cups water [0072] It should be noted that in Example 4 describing the preparation instructions using sauteed ingredients, that onions may be first browned in the oil or fat after which the onions may be discarded. The remaining oil, which will now include an onion flavor, may be then used to prepare (i.e., fry) the bean flakes to produce the refried bean product in accordance with preparation styles as used in Mexican Hispanic recipes for refried beans. [0073] In light of the four above-listed examples, it will be appreciated that the parameters described may be adjusted according to suit the particular conditions wherein such process may be used. In addition, such parameters may be adjusted depending on whether and to which extent the relative amounts of material are used in proportion to one another. It should also be noted that the foregoing examples are not limiting and are merely representative of various aspects and embodiments of the present invention. [0074] Importantly, the act of frying facilitates browning which develops the distinctly authentic flavor of true frijoles refritos (i.e., “really fried bean”) that is not achievable using prior art dehydrated refried beans that are only reconstituted with hot water by various means. Browning also increases the depth and concentration of flavors in the bean product thereby improving the overall quality of the refried beans. [0075] Additional modifications and improvements of the present inventions may also be apparent to those of ordinary skill in the art. Thus, the particular combination of steps described herein are intended to represent only certain embodiments of the present invention, and are not intended to serve as limitations of alternative methods of processes within the spirit and scope of the invention.

Provided is a method for rapid preparation of authentic refried beans from dehydrated starting material such as bean flakes. The method comprises the steps of providing a heated cooking surface, adding dehydrated beans to the heated cooking surface, adding water, stirring the mixture to achieve a bean mixture or slurry until the product begins to pull away from the heated cooking surface and browning begins to occur. The heated cooking surface optionally comprises cooking oil and further optionally comprises ingredients for sauteing thereon. This method enhances and intensifies the flavor of the refried bean product, thus producing a traditional frijoles refritos.

REFERENCE TO CO-PENDING APPLICATION [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 12/480,111 entitled “Insect Protection Garment” that was filed Jun. 8, 2009 by Gary Hunt, the entire contents of which are herein incorporated by reference. OVERVIEW [0002] This invention is for protection from bothersome and biting insects normally occurring in outdoor areas. It is a one piece, self-supporting total body covering. It will be made mostly of see-through netting material impervious to insects. Most importantly it will create a large enough space, inside the netting, to allow the wearer to eat, drink and relax while doing normal activities, without having to remove the garment, thus reducing exposure to annoying and harmful insects. The netting will be well away from the face making it comfortable to wear for long periods of time. It will be easy to deploy, wear, remove and transport. FIELD OF DISCLOSURE [0003] This invention is an improvement on all other types of insect protection garments for anyone in an outdoor area where bothersome insects are present. It is designed to be easy to use and comfortable to wear. BACKGROUND OF THE INVENTION [0004] Previously users of the outdoors have had to use either a head net or a head net in combination with a full body suit to protect themselves from insects. Head nets are uncomfortable, especially if you have to wear one for hours, or all day, or day after day as is the case when working or camping outdoors. The netting is only inches from the face, which gets annoying very quickly and makes activities such as eating very difficult. To eat, the head net must either must be removed thus exposing the person to the insects, or the user can try to pull the neck elastic out far enough to get a fork full of food into the mouth, which is difficult, and also creates an opening for insects to enter, thus undermining the protective aspect of the head net. Some try to solve this problem by eating in a tent, this is not recommended because animals are attracted to food smells and bears, skunks etc may come to the tent looking for a meal. [0005] Suit type body protection must be worn over full length clothing as the netting cannot be held away from the skin. This makes suit types very uncomfortable on hot days when insects are present. They also must be used in conjunction with a head net which fails to address the problem of how to eat and perform other necessary tasks without creating an opening for insects to enter or removing the head net. [0006] Some users of the outdoors rely on chemical repellents on their skin or clothing. Recent reports on these chemicals safety on the body make many reluctant to place it on the skin or inhale the vapors given off by these harsh chemicals even when placed on clothing. Some have label warnings of chemical stains if placed on clothing, and have to be re-applied frequently to be effective. [0007] The Alquist et al, U.S. Pat. No. 5,717,990 is a hood arrangement, and fails to address the need for a larger inside area to eat, read etc. The Alquist hood also hangs very close to the face which is annoying. It also fails to address the ability to be folded into a small and more pack able size. Also the crown piece is made of mesh material that provides little shade and no rain protection. It can be raining hard enough to get a person wet, yet not deter the insects. It also appears that the reinforcing cross strips on top lay directly on the head potentially making it uncomfortable after many hours of use. The Alquist et al hood has no openings for convenience, necessitating it to be opened or removed frequently to perform simple tasks. [0008] The Merrill, U.S. Pat. No. 5,091,993 and Myers U.S. Pat. No. 4,395,781 are both suit type of garments that would be extremely hot on even moderately warm days. The face netting can be opened for eating etc, but there is nothing to prevent insects from flying inside the head piece while opened, thus undermining the protective aspect of the garment. [0009] So what is desired is a garment that is one piece, light weight, covers the whole body and has a large enough inside space so you can eat, read etc and has openings for convenience so the garment will need to be removed as little as possible. It has a top that not only blocks insects from entering, but also provides shade and rain protection and allows the user to wear shorts and tee shirt on hot days. SUMMARY [0010] This invention is intended to be worn to provide protection from insects and to be easy to deploy, wear, remove and transport. It is to be used by people who wish to engage in outdoor activities where enjoyment of such activities may be compromised by bothersome or biting insects. [0011] It can also be used by military personnel deployed in areas where biting insects are a big problem and they are faced with long exposure times and where the possibility of contracting malaria is a factor. This invention could also help the populations in poorer countries or any place where there is a danger of malaria. There are bug nets for the heads and beds but none for the body, this invention fills that need. [0012] A key of this invention is to have insert protection that can be worn over regular clothing, including light weight shirts and shorts that are normally worn outdoors when the weather is hot. Biting insects thrive in hot weather and having to wear a long sleeve shirt and long pants on 90 degree plus days is dreadful and possibly dangerous as such clothing could facilitate heat stroke. [0013] It is the object of this invention to provide a large enough inside space as to not be annoyed by netting close to the face. Also to allow a large enough inside space for activities such as eating, drinking, smoking, sewing, repairing, cleaning gear or reading a map or book or writing in a journal, without fear of biting bugs. [0014] A key of this invention is the spring steel, or plastic ring of the top to be the only support necessary for this garment. Also, the ring of the top will hold the netting well away from the face of the wearer creating a space inside impervious to bugs. Another key to this invention is that the ring on top will be sewn into the outer edge of the top material so as to allow it to be twisted and folded to approximately one third of its unfolded size to make it much easier to pack and transport. [0015] Another important aspect to this invention is the opening in the front, at approximately waist level, will have a fabric hook and loop fastener or similar closure that is large enough to pass a plate of food, a book, etc inside. The opening for men will be located where a zipper on a regular pair of men's pants is located to facilitate the use of a restroom as needed. This will also have a fabric hook and loop fastener or similar closure. [0016] The seating area, which is in back, at waist level, extending down to just above the back of the knee, will be made of a durable material such as nylon so as to reduce the possibility of wear and tear when sitting on abrasive surfaces such as rocks or logs. The opening in the seating area will also be large enough to allow the use of a restroom without removing the garment and will have a fabric hook and loop fastener or similar closure. [0017] There will also be a round piece of cotton or other soft material sewn onto the inside of the top to deny insects the ability to bite the wearer on the head. There will also be a chin strap made of elastic strap material or cloth string with a cord lock, permanently attached to the round piece of cloth material attached to the top. It will be long enough to comfortably reach under the chin of the wearer to hold the garment in place. [0018] There will be a strip of the durable nylon material at the bottom to prevent wear if dragged on the ground. There will be elastic straps sewn to the bottom strip that can be looped under the shoes to hold the garment down far enough to prevent insects from entering from the bottom. [0019] The garment can be rolled up to waist level or to shoulder or neck level depending on how much of the body the wearer wants to protect. [0020] The entire bottom of the garment will be open to allow entry into the garment and make removal easy. Also the garment can be closed at the bottom around the shoes to keep insects from getting inside. This also will allow the wearer to walk around the campsite, etc. Also, if the wearer prefers to bring the feet inside, the entire bottom of the garment can be sealed with the fabric hook and loop fastener. BRIEF DESCRIPTION OF THE DRAWINGS [0021] The above-mentioned aspects of the present invention and the manner of obtaining them will become more apparent and the invention itself will be better understood by reference to the following description of the embodiments of the invention, taken in conjunction with the accompanying drawings, wherein: [0022] FIG. 1 is the front elevation of the garment. [0023] FIG. 2 is the right elevation of the garment. [0024] FIG. 3 is the rear elevation of the garment. [0025] FIG. 4 demonstrates how a nylon strip of material should be attached to the top and the bottom of the netting material. [0026] FIG. 5 demonstrates how the spring steel or plastic hoop should be sewn into the material on the top piece of the garment. [0027] FIG. 6 illustrates the lower details of the insect protection garment. [0028] FIG. 7 illustrates a bottom view of the insect protection garment. [0029] FIG. 8 illustrates a lower perspective view of the insect protection garment. [0030] FIG. 9 illustrates a side perspective view of the insect protection garment with a portion of the mesh netting removed. [0031] FIG. 10 illustrates a front view of the insect protection garment with cross-sections at various elevations. DETAILED DESCRIPTION [0032] The embodiments of the present invention described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of the present invention. [0033] In FIG. 1 the front elevation of the garment for the protection from insects is illustrated, it is a one piece total body covering. It can be made as a large size for adults or smaller sizes for smaller adults or children. It will be constructed mostly out of see-through insect barrier netting and nylon. The top piece 1 is made of nylon or other similar material that will provide a barrier from insects and shade and rain protection for the wearer. Sewn into the outer edge of top piece 1 is preferably a narrow spring steel hoop, but maybe a strong plastic hoop 2 that will provide support for the garment and should have the ability to be twisted and folded for packing convenience. [0034] The top piece 1 will be made of a circular piece of nylon or similar material that is commonly used to make outdoor clothing or tents. The edge will be sewn in such a way as to prevent fraying. [0035] The spring steel or plastic hoop 2 will be sewn into the outer edge of top piece 1 . Top piece 1 will be folded over at the edge so the hoop 2 will be between the layers of material. Double stitching for strength is recommended. [0036] The netting 11 , that extends down below the top piece 1 will be sewn to the outer edge of the top piece 1 . Before sewing the netting 11 to the top piece 1 , a strip of nylon 12 should be sewn to the top of the netting 11 where it will be attached to top piece 1 . The strip of nylon 12 should be folded over so the top of the netting 11 will be between the layers of the folded nylon 12 and then double stitched for strength. Then the strip of nylon 12 with the netting 11 attached can be sewn to top piece 1 and double stitched for strength. The top piece 1 is tightly stretched across hoop 2 (or resilient loop) to transfer the weight of the netting 11 and hoop 2 to the head piece 8 with minimal sagging of the top piece 1 . [0037] The arm openings 3 and 7 may have a permanently attached sleeve (not shown) and allows the wearer to extend the hand and arm outside of the netting to cook, operate a camera, set up a tent, etc. If a sleeve is attached to openings 3 and 7 , a strip of nylon should be sewn on the end of the sleeve that will be attached to the garment and then the nylon sewn to the garment. The sleeve should be made of netting or nylon material. With or without the sleeve the opening can be closed, preferably with a fabric hook and loop fastener, or with a zipper or other types of fabric closing systems. The upper front opening 4 should be large enough to pass a plate of food or an article of clothing, etc, inside the garment or passing such items outside of the garment. This opening will be closable with a fabric hook and loop fastener or similar system. The lower front opening 5 will be for the males convenience when using the restroom and can be closed with A fabric hook and loop fastener or similar system. FIG. 3 illustrates an example of a fabric hook and fastener 17 being secured adjacent to one of convenience openings. [0038] The bottom opening 6 can be opened to a size large enough to allow the wearer to put the garment on and off. It can also be closed at the bottom with a fabric hook and loop fastener or similar system. It will have a strip of nylon sewn around the entire bottom to prevent wear. It should be sewn to netting 11 the same way as the nylon strip 12 is sewn to netting 11 in FIG. 4 . Fabric hook and loop fastener can then be attached to the bottom strip of nylon so the entire bottom of the garment can be opened or closed. If the wearer wishes to pull the feet inside the garment the entire bottom of the garment can be closed with a fabric hook and loop fastener. If the wearer wishes to walk with the garment on, the bottom opening can be closed around the tops of the shoes and remain closed between the feet to allow mobility while still denying insects entry. The bottom strip may have two loops of elastic (not shown) that can be looped under the shoes to hold the garment down close to the shoes. [0039] Before a fabric hook and loop fastener is attached to the garment it should be sewn to a piece of nylon first rather than sewing a fabric hook and loop fastener directly to the garment. Then the nylon with the fabric hook and loop fastener attached can be sewn to the garment. Double stitching for strength is recommended everywhere anything is attached. [0040] The circular head piece 8 is sewn to the top piece 1 to keep insects from reaching the wearers head and as an attachment for chin strap 9 . The chin strap 9 keeps the garment from sliding around and keeps the garment in place if wind is present. It can be made of an elastic material or cotton, like a shoe string with an adjustable stop so the wearer can adjust for comfort under the chin. [0041] FIG. 2 shows the garment from the right elevation, the left elevation is a mirror image of the right elevation. The circular head piece 8 is shown and should be sewn to the inside center of top piece 1 and should be large enough and thick enough to prevent insects from reaching the head when trying to bite through from the top of top piece 1 . [0042] Chin strap 9 is made of either of thin elastic material or cotton material such as a shoe string that has adjustable cord lock, like the type found on stuff sacks, so the chin strap can be adjusted for comfort. It will be sewn to head piece 8 just above the ears. It will prevent the garment from sliding around and keeps the garment in place if wind is present. [0043] The arm opening 7 is shown for the right arm to extend out as needed and close with a fabric hook and loop fastener. [0044] FIG. 3 shows the rear elevation. The rear convenience flap 10 is shown. It will be a flap type or trap door type opening similar to the rear opening seen in one piece long underwear. It will have a fabric hook and loop fastener or similar closer on the left, right and bottom that can be opened for restroom use. The fabric hook and loop fastener should be sewn to the nylon flap along the left, right and bottom edges, and fabric hook and loop fastener sewn to nylon strips and then sewn to the left, right and bottom edges of the opening in the garment. The top of flap 10 will be sewn to the garment. [0045] FIG. 4 shows the way the nylon strip of material 12 is folded over netting material 11 so that the netting material 11 is sandwiched between the folded piece of nylon strip 12 . Then with double stitching die folded piece of nylon strip 12 with the netting material 11 between the fold of nylon strip 12 is all sewn together. Then nylon strip 12 can be attached along the outer edge of top piece 1 , double stitching is recommended. [0046] FIG. 5 demonstrates how spring steel hoop 2 is sandwiched between the folded over edge of top piece 1 . The folded over edge of top piece 1 with spring steel hoop 2 between the fold of the edge of top piece 1 is all sewn together. Double stitching is recommended on both sides of spring steel hoop 2 . FIG. 6 highlights the lower portions of the garment. [0047] FIG. 7 illustrates a bottom view of the garment with the head piece 8 fully circumscribed by the outer perimeter 15 of the top piece 1 . Substantially all of the outer perimeter 15 of the top piece 1 is secured to the hoop 2 (also referred to as a loop). The head piece 8 is substantially separated from the outer perimeter 15 of the top piece and the hoop 2 in that there is a significant minimum separation of the head piece 8 from both the outer perimeter 15 and the hoop 2 . Substantially separated is herein defined to mean having a significant minimum separation between objects. In the illustrated example, the head piece 8 is separated from the hoop by a minimum hoop distance 20 of twelve inches. In an exemplary embodiment, the diameter 22 of the top piece is at least two feet. The head piece 8 is separated from the outer perimeter 15 by a minimum perimeter distance 25 of twelve and a quarter inches. It should be understood that these distance are examples, and other distances, such as 6 inches, 9 inches, 18 inches, and 24 inches may also be used as the minimum separation distances between the head piece 8 and the outer perimeter 15 and hoop 2 . [0048] FIG. 8 illustrates a lower perspective view of the garment with the netting 11 in the form of a tube 30 fully circumscribing the head piece 8 . FIG. 9 illustrates a lower perspective view of an insect protection garment with a portion of the netting cut away. The netting 11 is in the shape of a cylindrical tube 30 that has a height 35 of at least three feet; however other embodiments will have a height 35 of between 5 and 7 feet. The outer perimeter 15 of the top piece 1 in the illustrated example has a length of at least six feet and the tube 30 has a similar circumference. [0049] FIG. 10 illustrates an example of a mesh tube 30 having a bottom opening 6 near the feet of a user and a top opening 40 at the top piece 1 . Adjacent to the top opening the tube 30 has a first horizontal perimeter 45 that has a first length. Midway between the top opening 40 and the bottom opening 6 , the tube 30 of netting 11 has a second horizontal perimeter 50 that is the same length as the first horizontal perimeter 45 . Adjacent to the bottom opening 6 , the tube 30 has a third horizontal perimeter 55 that has the same length as the other two horizontal perimeters. In the illustrated example, the first and second horizontal perimeters ( 45 and 50 ) are substantially circular while the third horizontal perimeter has an erratic shape due to the netting being gathered around the feet of the user. In the illustrated example, the first horizontal perimeter 45 and the second horizontal perimeter 50 are separated by a distance 60 of at least two feet. In an exemplary embodiment, the first and second horizontal perimeters are separated by at least three feet with the total height of the mesh tube being approximately six feet. In an exemplary embodiment, the top piece is constructed of a canvas material that provides shade to the user while the mesh tube is see-through and only minimally obstructs the user's vision. [0050] It should be understood that the descriptions of the invention were made as specific as possible and that changes in materials, openings, support systems and closer systems, fall within the true scope of the invention and are covered by the stated claims. [0051] While exemplary embodiments incorporating the principles of the present invention have been disclosed herein, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

A one piece, self-supporting total body covering for protection against insects to be used by campers, hikers, fisherman, hunters or by professionals who work in the outdoors such as scientists and photographers. The garment will be mostly made of a see-through material impervious to insects. What is new and different about this garment is that it will create and area inside the netting large enough to eat, read, etc, and keep the user protected from insects and comfortable for long periods of time. It will be easy to deploy, wear, remove and transport.

BACKGROUND OF THE INVENTION [0001] This invention relates to a stabilization brace and more particularly to a support which stabilizes the ankle and forefoot of the user at a desired neutral position. [0002] The supination of a foot combines inward rotation at the ankle, adduction of the hind foot inversion of the forefoot and medial arch elevation. Basically, supination produces a medial (inward) movement at the talocalcaneal (subtalus) joint known as inversion as well as similar movement between the hind foot (talus) and mid foot (navicular) bones. A foot that supinates appears to naturally favor the lateral region or outside edge of the foot. A certain amount of supination is normal during the toe off stage of running, i.e., when the heel first lifts off the ground until the end of the step. During excessive supination, the lateral structures of the foot tighten which may rupture or avulse portions of the lateral collateral ligaments resulting in a “rolling over” of the ankle or ankle sprain. [0003] The pronation of a foot produces opposite foot behavior of the subtalar joint including adduction of the forefoot, eversion of the hind foot and dorsiflexicon. Basically, pronation produces a lateral (outward) movement of the foot at the subtalar joint known as eversion as well as similar hind foot and mid foot movements. A foot that pronates appears to naturally favor the inside or medial edge of the foot. The foot naturally pronates to absorb the shock resulting from the heel hitting the ground. Excessive pronation increases the stress on the inside/medial portion of the foot which may lead to various injuries such as arch strain, heel pain, inner ankle pain and shin splints. [0004] Accordingly, it is desirable to preclude excessive pronation and/or supination of the ankle joint and foot. Thus, various devices have been proposed to prevent (Docket 3588) ankle and foot injuries by attempting to maintain the foot in a “neutral position”. Although assumably effective in their operation, such devices have failed to simultaneously provide the effective stabilization of the ankle and foot and in a neutral position. This desired stabilization, which resists excessive pronation and/or supination, positions the foot for a proper impact during walking, running and jumping rather than on the edge of the foot while in an excessive pronated or supinated position. [0005] In response thereto, a stabilization brace is presented for simultaneously maintaining the ankle and the foot at a neutral position while permitting natural movement through a full range of motion. The brace presents an elastic, sock-like body positioned in a compressive fit about the ankle and foot of the wearer. A pair of torque straps are anchored to the body adjacent the distal (head) ends of the first and fifth metatarsals. Each strap is then wound about the forefoot, heel and ankle and anchored above the ankle joint so as to present countervailing forces along the foot and ankle joint complex. These forces resist excessive movement of the foot and ankle from their normal, neutral position without precluding normal movement thereof. The brace design anatomically fits either foot about the heel, ankle and forefoot aspects thereof. A first closure system which allows the sock-like body to be easily slipped onto the foot. A second closure system maintains the circumferential integrity of the brace about the ankle joint region and presents anchor zones for the free ends of the bilateral torque straps. This structure allows the user to variably adjust the tension on these torque straps and thus the countervailing forces presented thereby. [0006] It is therefor a general object of the invention to provide a brace which simultaneously secures the ankle and the foot at a neutral position so as to resist excessive supination and pronation thereof. [0007] Another object of the invention is to provide a brace, as aforesaid, which presents a pair of torque straps which present countervailing forces along the ankle and foot regions extending between the metatarsal heads and the superior region of the ankle joint complex to resist excessive pronation or supination. [0008] A further object of this invention is to provide a brace, as aforesaid, having a sock-like body which slips over the foot and provides a compression fit thereto between the metatarsal heads and the superior region of the ankle joint complex. [0009] Another object of this invention is to provide a brace, as aforesaid, wherein a first closure system allows the brace to be used with variously sized feet while maintaining a compressive fit. [0010] A still further object of this invention is to provide a brace, as aforesaid, having a second closure mechanism for providing circumferential forces about the ankle joint complex while presenting anchor points for the torque straps. [0011] Another particular object of this invention is to provide a brace, as aforesaid, which presents a pattern to fit the ankle, heel and forefoot aspects of the foot of the wearer. [0012] A more particular object of the invention is to provide a brace as aforesaid, which uses heat seals along the seams of the brace pattern in lieu of stitching so as to enhance the fit of the brace. [0013] Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein is set forth by way of illustration and example, a now preferred embodiment of this invention. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a top/dorsal view of the right foot of the wearer and showing in phantom lines the metatarsals and phalanges of the foot of the wearer; [0015] FIG. 2 is a perspection view of the right foot of the wearer showing the sock-like body thereon, the unwrapped countervailing force straps (fragmentarily shown), the first closure system prior to full engagement and the second closure system disengaged from the ankle joint complex; [0016] FIG. 3 is a view, as in FIG. 2 , showing the FIG. 2 closure system in an engaged/locked position; [0017] FIG. 4 is a view as in FIG. 3 showing the initial wrapping of the medial torque strap about the dorsal aspect of the foot, underneath the heel and along the medial side of the ankle joint complex prior to engagement of the free end of the medial strap to a superior position above the ankle joint complex; [0018] FIG. 5 is an opposed perspective view of the foot in FIG. 4 showing the initial wrapping of the lateral torque strap across the dorsal aspect of the foot; [0019] FIG. 6 is a view of the FIG. 5 foot showing the continuing engagement of the lateral strap across the dorsal aspect of the foot, underneath the heel extension of the lateral strap along the lateral side of the ankle joint complex prior to engagement of the free end of the lateral strap to a superior position above the ankle joint complex; [0020] FIG. 7 is a bottom view of the foot showing the metatarsal anchor zone of the straps adjacent the free edge of the body and the extension of the straps wound under the heel; [0021] FIG. 8 is a lateral view of the foot with brace secured thereon; [0022] FIG. 9 is a view of the pattern of the brace showing the tongue element; [0023] FIG. 10 is a view of the pattern of the brace showing the portion for encompassing the ankle joint; [0024] FIG. 11 is a view of the pattern of the brace showing the portion for encompassing the heel and forefoot; [0025] FIG. 12 is a view of one of the counter force straps; and [0026] FIG. 13 is a diagrammatic view showing pronation and supination of the right foot from the rear thereof. DESCRIPTION OF THE PREFERRED EMBODIMENT [0027] Turning more particularly to the drawings, the brace 100 comprises a sock like body 110 made of an elastic material. The body 110 presents first 112 and second 114 integral sleeves made from joined blanks 112 ′, 114 ′. The body 110 provides a compression fit about the ankle joint complex and forefoot of the wearer. The forefoot is described as that region of the foot extending from the heel to approximate the distal/head ends of the first 2100 and fifth metatarsals 2500 . The body 110 presents a first free edge 120 which circumscribes the foot at a superior position above the ankle joint complex. A second free edge 122 circumscribes the foot adjacent the distal ends/heads of the first 2100 and fifth 2500 metatarsals. It is preferred that this edge 122 not extend beyond such distal ends as it may present discomfort to the foot during flexion. As such, upon slipping the body 110 over the foot, the body 110 presents a compression fit between these edges 120 , 122 . [0028] The initial extension of the foot through the opening presented by the free edge 120 is enhanced by a closure system 200 . This closure system is presented by a U-shaped notch 210 which extends from the free edge 120 . As such, first and second flaps 130 , 140 are presented which allow the user to increase the initial opening presented by the upper free edge 120 . As such, a foot of various sizes may be initially extended through this free edge 120 for ultimate extension of the phalanges 2300 through the downstream free edge 122 . Aperture 190 allows for extension of the heel therethrough. [0029] The closure system 200 presents a plurality of tabs 230 which are secured at one end along the longitudinal extent of the notch 210 on flap 130 . These tabs have Velcro™ fastener material 232 on the inside thereof. Complementary Velcro™ material 234 is located along the extent of the notch 210 on the opposed flap 140 . The engagement of each tab 230 fastener 232 to the complementary fastener 234 enables the user to adjust the compression of the sleeve 112 about the ankle joint region as the degree of overlap of these fasteners 232 , 234 can be selectably adjusted. A tongue 260 is attached to the interior of the body portion 112 for extension along notch 210 so as to preclude the sleeve 112 and tabs 230 from directly contacting the user. [0030] Further attached to the rear of body portion 112 adjacent edge 120 is a second closure system 300 which presents first 310 and second 312 straps made of an elastic material. The straps 310 , 312 present complementary Velcro™ fasteners 314 , 316 at the free ends thereof. Accordingly, these flaps are wrapped circumferentially around the ankle joint complex and attached one to the other as shown in FIG. 3 . The degree of overlap of the complimentary fasteners 314 , 316 adjusts the compressive fit of straps 310 , 312 about the ankle joint and thus maintains the circumferential integrity of the brace about the ankle joint complex. These straps 310 , 312 further present Velcro™ fasteners 316 , 316 ′ along the lateral and medial sides of the ankle joint which mate with complementary Velcro™ fasteners at the ends of the bilateral torque straps as to be further described. [0031] The brace 100 further includes medial 500 and lateral 600 countervailing force straps which are anchored at a location 550 underneath the sleeve 114 and adjacent the free edge 122 ( FIG. 7 ). These straps, 500 , 600 are preferably made of a non-elastic material. It is understood that the straps 500 , 600 may be a single elongated strap anchored at 550 so as to present the medial 500 and lateral 600 straps or separate straps extending therefrom. [0032] Accordingly, the right foot being shown, the medial strap 500 is first wrapped so as to provide a force along the forefoot, heel and ankle regions of the wearer. As such, a first extension 510 of strap 500 extends from zone 550 and to the medial side of the foot, across the dorsal aspect of the forefoot and rearwardly towards the lateral side of the heel. A second extension of the strap 520 is wound underneath the heel as best shown in FIG. 7 . Subsequently, the remaining portion of the strap 530 is then brought upwardly along the medial side of the ankle joint region as best shown in FIG. 4 . The end of the strap 500 presents Velcro™ material 532 designed to mate with the Velcro™ 316′ presented on flap 312 of the closure system 300 . As such, the wearer by pulling on strap 500 at extension 530 can variably adjust the mating of the strap 550 end to this Velcro™ mating material 316 ′ and thus adjust the tension along the medial strap 500 . In turn this tension is transmitted as a force along the medial and dorsal aspects at the foot, the lateral side of the heel, underneath the heel and along the medial side of the heel and ankle joint complex. [0033] Subsequently, a first extension 610 of the lateral strap 600 is wound about the dorsal aspect of the foot from the lateral side thereof, across the dorsal aspect of the forefoot and rearwardly towards the medial side of the heel ( FIGS. 5, 6 ). A second strap extension 620 is then wound underneath the heel ( FIG. 7 ) with a third extension 630 brought upwardly along the lateral side of the heel and ankle joint ( FIG. 8 ). The end of the strap extension 630 likewise presents a Velcro™ fastener 632 which engages complementary material 316 presented on strap 310 of the closure system 300 . Again, the variable anchoring of the strap extension 630 to this Velcro™ material 316 enables the user to adjust the tension along this strap 600 . In turn this tension is transmitted as a force, opposite that force presented by strap 500 , along the lateral and dorsal aspects at the foot, the medial side of the heel, underneath the heel and along the lateral side of the ankle joint complex. [0034] Accordingly, the body 110 along with the closure systems 200 , 300 provides compressive forces about the ankle and foot of the user. The medial 500 and lateral 600 straps present countervailing forces beginning at the metatarsal heads, along the forefoot and upward along the ankle joint complex. As previously discussed, pronation and supination of the foot respectively present opposed movements at the subtalar joint, hind foot and mid foot such that the foot favors the lateral region foot (supination) or the medial region (pronation) of the foot. Straps 500 , 600 thus present countervailing forces in these regions so as to resist movement of the ankle and foot, inclusive of its underlying structures, from excessive pronation or supination. Thus, as the foot is held in a neutral position, the probability of the user landing on an excessively supinated or pronated foot during walking, jumping and/or running is reduced which reduces the probability of injury. The use of these counter force straps 500 , 600 with or without the compressive fit offered by the body 110 and the compression mechanisms 200 , 300 enhances the prophylactic advantages of the brace 100 . [0035] Although a now preferred embodiment of this invention has been described herein, it is understood that such a description it is not limited except as set forth in the claims and allowable, functional equivalents thereof.

A stabilization brace presents a compressive, sock-like body for a compressive fit about the ankle joint and forefoot. A pair of force straps extend from the metatarsal heads and along the opposed lateral and medial regions of the foot and ankle to offer countervailing forces therealong. First and second closure systems secure the body to the foot and offer circumferential support thereto. The brace resists excessive supination and pronation of the foot, ankle joint and underlying structures.

BACKGROUND OF THE INVENTION This invention relates to new and useful improvements to field cultivators. Conventional cultivators utilize spring or hydraulically loaded mountings so that if one cultivator blade strikes an obstruction such as a rock or the like, during operation, it trips rearwardly to clear the obstruction whereupon the springs or hydraulic assemblies, return this particular cultivator blade to its original position. Unfortunately such devices are difficult to control insofar as the pitch and depth of the cultivator sweeps are concerned. This is particularly so when ground of varying densities is being cultivated. SUMMARY OF THE INVENTION The present invention overcomes these disadvantages by interconnecting a plurality of front and rear cultivator shank assemblies together in such a way that if one strikes an obstruction, it moves rearwardly to clear same and at the same time moves the remainder of the set of cultivator assemblies forwardly so that they absorb the movement of the tripping cultivator assembly. When the obstacle is passed, the engagement of the remaining cultivator assemblies with the ground, forces them to the original position which at the same time, due to the interconnecting linkage returns the original one to the preset condition. The linkage system, eliminates the use of springs but provides trip action of the shanks to clear rocks and other hard objects. One aspect of the invention is therefore to provide a cultivator of the character herewithin described comprising in combination a frame, ground engaging wheels mounted on said frame to support same, a plurality of sets of cultivator shank assemblies pivotally mounted by one end thereof to said frame adjacent the front and rear thereof, a cultivator tool on the lower ends of said shank assemblies, and linkage means interconnecting the shank assemblies of each set together whereby if at least one of said shank assemblies moves rearwardly relative to said frame, the other shank assemblies of the same set move forwardly, the total distance moved forwardly of said other shank assemblies of said set being substantially equal to the distance moved rearwardly by said one shank assembly of said set. Another object of the invention is to provide a device of the character herewithin described which can be utilized with a fixed frame, or alternatively, can be extended in width by connecting various solid frame sections together, adding extension kits bolted to either end of the solid frames or, if desired, adding fold-up wing sections which can be attached to either end of the solid frame. A yet further object of the invention is to provide a device of the character herewithin described, which can, if desired, be pulled from one end for transport purposes thus enabling a relatively wide machine to be transported readily and easily. A still further object of the invention is to provide a device of the character herewithin described which may include means to adjust, within limits, the tilt to the sweeps attached to the shanks. A still further object of the invention is to provide a device of the character herewithin described which is simple in construction, economical in manufacture and otherwise well suited to the purpose for which it is designed. With the foregoing objects in view, and other such objects and advantages as will become apparent to those skilled in the art to which this invention relates as this specification proceeds, my invention consists essentially in the arrangement and construction of parts all as hereinafter more particularly described, reference being had to the accompanying drawings in which: DESCRIPTION OF THE DRAWINGS FIG. 1 is a top plan view of part of the cultivator. FIG. 2 is a fragmentary plan view of the interconnected linkage per se. FIG. 3 is a side elevation of FIG. 1. FIG. 4 is a fragmentary partially sectioned view of one of the hinge connections to the frame. FIG. 5 is a view at right angles to FIG. 4. FIG. 6 is a fragmentary isometric view of part of the frame showing one set of shank assemblies. In the drawings like characters of reference indicate corresponding parts in the different figures. DETAILED DESCRIPTION Proceeding therefore to describe the invention in detail, reference character 10 illustrates a substantially rectangular frame including front longitudinal chassis members 11, rear longitudinal chassis members 12 and cross chassis members 13. Although only one such section is shown, nevertheless it will be appreciated that this section can be of varying widths and can, if desired, be bolted to adjacent similar sections if desired. Also, folding wings sections can be provided but as such wing sections are conventional, it is not believed necessary to describe same further. A rock shaft 14 is mounted for rotation to the chassis adjacent the front side 11 thereof and ground engaging wheels 15, mounted upon axle struts 16, are supported upon the rock shaft and support the frame above the ground as clearly shown in FIG. 3. A fluid operator 17 is mounted on the frame cross member 13 and is operatively connected to a link 18 which in turn connects to the rock shaft 14 so that extension and retraction of the fluid operator 17, lowers or raises the frame 10 relative to the wheels 15 thus controlling the depth of penetration of the shank assemblies in the usual manner. A forwardly extending hitch 19 is pivotally connected to the front member 11 of the chassis by means of pivot pins 20 and the hitch 19 extends to a source of power in the form of a tractor (not illustrated) in the usual way. Sets of cultivator assemblies are provided and are mounted in the frame, one such set being indicated collectively by reference character 21. Each set may consist of four or more individual cultivator assemblies collectively designated 22 interconnected together by linkage as will hereinafter be described. Each cultivator assembly includes a cultivator shank 23 having a cultivating tool such as a blade 24 mounted upon the lower end thereof. Alternatively, the cultivator shank may take the form of a spring shank with a ripper shank tool on the lower end thereof (not illustrated). Each shank 23 is secured by the upper end thereof to one end 25 of a crank arm collectively designated 26 pivoted intermediate the ends thereof between a pair of lugs 27 extending downwardly from the longitudinal frame members 11 or 12, reference character 28 illustrating the pivotal connection of the crank arms to the lugs 27. A rear connector 29 taking the form of a plate, is provided with pivot pins 30 extending from each end thereof which in turn engage spherical bearings 31 secured to the other legs or arms 32 of the crank arm 26 of an adjacent pair of cultivator assemblies. A front connector 33 connects adjacent pairs of front cultivator assemblies together. The front cultivator assemblies also include crank arms 26 mounted between lugs 27 similar to the mounting of the rear assemblies. The front connector includes a flat bar 34 with an offset portion 35 at one end thereof carrying a pivot pin 30A. A corresponding pivot pin 30A is secured to and extends from the other end 36 of the flat bar or plate 34 as clearly shown in FIG. 2 and these pivot pins 30A engage these spherical bearings 31 of adjacent front cultivator assemblies. A rocking link 37 is pivoted intermediate the ends thereof to a fixed support 38 extending below the front chassis member 11 and the front connector 33 is pivoted intermediate the ends thereof to one end of this rocking link 37 by means of a pivot pin 39 engaging through said one end and a lug 40 extending from one side of the plate 34. A connector link 41 is provided with lengthwise adjustment 42 within the length thereof and is pivotally connected by the rear end 43 thereof to intermediate the ends of the rear connector link 29 by means of pivot pin 44. The front 45 of the adjustable connector link 41 is pivotally connected to the other end 46 of the rocking link 37 and in this connection a plurality of apertures are formed in the end 46 anyone of which may be used to connect the adjustable connector link 41 by means of a pivot pin connection 47. In operation, the set of shank assemblies are connected together and the cultivating tools 24 are let into the ground by raising the wheels 15 by means of the fluid operator 17 thus enabling the weight of the frame to force the tools into the ground the desired amount. The implement is then moved forwardly by the associated tractor (not illustrated) and the sweeps or cultivating tools begin to cut through the ground at a depth desired and preset by the operator. If one of the cultivating tools engages an obstruction such as a rock or root, resistance is met thus causing it to pivot rearwardly around the pivot 28 until it has been raised high enough to clear the obstruction. Assuming that one of the front cultivator assemblies engages an obstruction, then rearward movement of this particular cultivator assembly will cause the other front cultivator assembly to move forwardly due to the pivotal action of the front connector 33. At the same time the connection of this front connector 33 with the rocking link 37, will cause the rocking link to pivot around its pivot point thus moving the adjustable connector link 41 forwardly together with the two cultivator assemblies operatively connected thereto at the rear. In an instance in which four shank assemblies 23 are connected together as in FIG. 2, the various linkage and angles are such that the sum of the movement of the other front cultivator assembly and the two rear cultivator assemblies is substantially equal to the distance moved by the front cultivator assembly striking the obstruction. This means that the movement is relatively slight and does not particularly interfere with the attitude of the cultivating tools 24. As soon as the obstruction is passed, the engagement of the three cultivator tools with the ground, forces them to move back to the original position and the linkage connection between the cultivator assemblies forces the other cultivator assembly back to its original position also. In other words the other cultivator assemblies attached to the one striking the obstruction, absorbs the movement of the one cultivator assembly which trips rearwardly to clear the obstruction. The interconnecting linkage eliminates the necessity for springs and hydraulic cylinders and the like and creates very little disturbance in the cultivating action. The lengthwise adjustment of the adjustable connecting link 41 together with the positioning of the front end thereof in one of the plurality of apertures in the rocking link 37, give the necessary adjustments depending upon circumstances and conditions. For example if a rod weeder (not illustrated) is attached behind rear shanks as is common practise, then this can be compensated for by the necessary adjustment at point 47. The difference in leverage determined by the adjustment in the outward end of the rocking link 27, where it connects to the adjustable connector link 41, at point 47, is also used to balance the difference in pressure normally found between the front and rear shanks. Also changing this length of the link 41 gives the desired tilt to the sweeps on the shanks. If two cultivator assemblies strike an object and move rearwardly together, the other two will also move forwardly always sharing the load and going back to equilibrium after the object has been passed. Although four shanks have been described and illustrated, other forms of interconnection may be made as illustrated in the left and righthand sides of FIG. 1. On the lefthand side of FIG. 1, five shank assemblies are shown connected together, two at the front and three at the rear. In this connection, the rear end 42 of the ajustable connector link 41 is connected to a balance bar 48 by means of pivot pin 49 and this balance bar is in turn connected to the rear connectors 50 by means of link 51 and pivot points 52 and 53. On the righthand side of FIG. 1, five shank assemblies are shown with two at the rear and three at the front. Under these conditions, the rear end of the adjustable connector 42 is pivotally connected to a balance bar 48A by means of pivot 54 with a link 51 extending to the rear connector 50 as clearly shown. A further connector link 55 is pivotally connected to the other end of the balance bar 48A and extends forwardly to a rocking link 37A which in turn is connected to the fifth cultivator assembly as clearly illustrated. If it is desired to transport the cultivator endwise, transport wheel assemblies 56 may be secured to the chassis upon either side thereof and an end hitch (not illustrated) is provided in the usual manner. However this does not affect the operation of the cultivator in the field in which the interconnected set of cultivator assemblies enables the load of an obstruction to be shared among a plurality of shank assemblies. Since various modifications can be made in my invention as hereinabove described, and many apparently widely different embodiments of same made within the spirit and scope of the claims without departing from such spirit and scope, it is intended that all matter contained in the accompanying specification shall be interpreted as illustrative only and not in limiting sense.

Four or more cultivator arms or shanks are pivoted to the front and rear of a main frame and are interconnected by linkage so that if a cultivator blade on one arm strikes an obstruction, then it moves rearwardly to clear same and at the same time the others that are interconnected, move forwardly by a lesser amount thus absorbing the movement of the cultivator blade striking the obstruction. When the obstruction is passed, the engagement of the remaining blades with the ground, returns them to the original position thus returning the tripped blade to the original position.

BACKGROUND [0001] Typical bathing installations such as spa systems employ a control system that operates the spa equipment and a control panel that allows the user to input user commands and data. Some programming features may be programmed by the user with the control panel, e.g., filter cycles, temperature settings, lighting settings, panel and/or temperature locking. Specific buttons on the control panel are actuated to operate the equipment, or to program features. BRIEF DESCRIPTION OF THE DRAWINGS [0002] Features and advantages of the disclosure will readily be appreciated by persons skilled in the art from the following detailed description when read in conjunction with the drawing wherein: [0003] FIG. 1 is a diagrammatic view of an exemplary spa installation, with enhanced security and control features. [0004] FIG. 2 is a diagrammatic view of an exemplary embodiment of a transponder or tag for activating features of the spa installation of FIG. 1 . [0005] FIG. 3 diagrammatically illustrates an exemplary embodiment of a card key with a bar code for activating features of the spa installation of FIG. 1 . [0006] FIG. 4 diagrammatically illustrates an exemplary embodiment of a finger print scanner for activating features of the spa installation of FIG. 1 . [0007] FIG. 5 is a schematic block diagram of an exemplary embodiment of a spa installation. [0008] FIG. 6 illustrates an exemplary control method RFID use with a spa, pool or other bathing installation. [0009] FIG. 7 illustrates an exemplary control method employing bar code or other optical code control with a bathing installation such as a spa or hot tub. [0010] FIG. 8 illustrates an exemplary method employing a finger print or other biometric scanner with a bathing installation such as a spa or hot tub. [0011] FIG. 9 depicts a flow diagram of an exemplary production technique employing an RFID tag to facilitate production. DETAILED DESCRIPTION [0012] In the following detailed description and in the several figures of the drawing, like elements are identified with like reference numerals. The figures are not to scale, and relative feature sizes may be exaggerated for illustrative purposes. [0013] An exemplary embodiment of a bathing installation 200 is illustrated in FIG. 1 . In this exemplary embodiment, the bathing installation is a spa system, but other exemplary bathing installations may include a pool installation, including a large municipal or school pool installation, or a whirlpool bath installation. The spa system 200 includes a spa tub 202 , and an electronic spa control system 206 for controlling the spa systems and features, including, for example, a spa water heater 212 , pump, air blower (the water pump and blower are not shown in FIG. 1 ) and spa operated accessories including yard or decorative lighting 210 . The spa system includes a spa cover 204 , which may be locked in a closed position by an electronically-controlled cover lock system 214 . A control panel 216 may be situated adjacent to or supported by the spa tub to provide user interaction with the control system 206 to set parameters, and initiate some activities. [0014] The spa control system may include one or more personalized mobile information bearing devices whose sensed presence or absence may enable features of the spa system to be activated. The personalized mobile information bearing device may be sensed or read by a sensor or reader comprising the control system. In one exemplary embodiment, the sensor is a Radio Frequency Identification (RFID) reader or sensor 220 that can interact with a mobile RFID tag 222 ( FIG. 2 ) as the personalized mobile information bearing device. In other embodiments, the personalized mobile information bearing device may be a card or a biometric characteristic of a user, such as a thumb or finger print or an eye. [0015] The RFID tag 222 is encoded with information which may be read by the sensor 220 when the tag is within range of the sensor 220 . The information may be read and interpreted by the sensor or the control system. The RFID tag may be a passive, active, or semi-passive RFID device. For some bathing installation applications, it may be preferred to use an RFID tag with a limited range so that the RFID tag must be within a few feet of the sensor 220 for the tag information to be read by the sensor. [0016] The coded information carried by the RFID tag is programmed or stored in a memory of the spa control system, e.g. in a location which identifies a given set of coded information as an authorized user of the spa installation. The RFID tag may be used in conjunction with the spa control system so that the sensed presence or absence of the RFID tag inside a certain distance from the spa control system will cause or allow certain spa functions to operate. These functions may include one or more of the following functions. [0017] Security Functions: [0018] 1. The cover locks 214 automatically unlock when the RFID tag 222 is present. [0019] 2. The control panel 216 will unlock, i.e. be rendered responsive to user inputs on the control panel, when the RFID tag is present. [0020] 3. The control panel 216 is locked when the RFID tag is removed from the spa area. [0021] 4. The cover locks 214 are armed when the RFID tag is removed from the area. [0022] 5. A cover alarm is armed when the RFID tag is not present, so that an alarm will be sounded, broadcast, or signaled when the cover is opened and the RFID tag is not present. [0023] Product Use: [0024] 1. Configurations may be stored in the system controller memory, and which run when the RFID tag is present. For example, these configurations can be programmed so that, when the RFID tag is present, the jets, light and blower will activate automatically. These activities are exemplary, and other programmed activities that are available to the spa can be programmed to activate when the RFID tag is present. [0025] 2. Different RFID tags can be associated with different programmed activities and for different preset actions, e.g. one RFID tag for daytime activities, a second RFID tag for night time activities, a third RFID tag for a parent, and a fourth RFID tag for children. Each tag has encoded therein a different code. [0026] Automatic Shutdown: [0027] 1. The spa controller may be programmed to shut down some or all equipment when the RFID tag is removed from the spa area. Some equipment may not be shut down when the RFID tag is removed; for example, in many applications, the circulation pump would not be disabled, or a low speed pump will continue to operate for a pre-determined filtration time. Examples of equipment that would be shut down include jets, lights, blowers mist sprayers, televisions, audio systems and other ancillary devices, [0028] 2. Some items such as the yard lighting may have a separate timer so that the yard lighting will turn off after the user has had an opportunity to return to the house. [0029] Inventory Control: [0030] Manufacturers of spas can use the RFID tags to manage inventory while the spa is in production. An RFID Tag may be attached to an inventory item and information about that item stored in the tag (order number, part number, serial number, date code, etc.) This allows a speedy inventory count to be made by walking an RFID scanner down a row of items with RFID Tags attached. RFID tags may also facilitate the tracking of high-value items through a supply chain or delivery system. [0031] In another exemplary embodiment, the personalized mobile information bearing device may be a card encoded with information. The spa system may include a card reader 230 , including a receptacle into which a card (a mobile information bearing device) with a bar code or magnetic code strip may be inserted for reading. FIG. 3 depicts an exemplary bar code card 232 which may carry a code, e.g. a bar code, which is stored in memory of the spa control system 206 . The cards could alternatively utilize magnetic strips such as hotel room keys, or even a punch card with holes to create the codes. The card 232 may be carried by an authorized user of the spa system, and by recognizing the code carried by the card 232 , the spa control system may activate features of the spa system. [0032] Alternatively or in addition to the card reader 230 , the spa system 200 may also include a biometric scanner 240 , e.g. a scanner such as a finger print scanner or a retinal scanner ( FIG. 4 ). In this embodiment, the user's body, e.g. the user's digit or eye in the case of a retinal scanner, serves as the mobile information bearing device. A user may enter his biometric information during a programming mode, and the scanner 240 may be used to activate features of the spa system. The card reader and fingerprint scanner may be alternatives to the RFID tags. [0033] In the case of a card reader 216 , the card 232 may be left in the reader while the spa is being used. Removal of the card may be interpreted by the spa controller in the same manner as removal of an RFID tag from the spa area, e.g. to activate an automated shutdown of spa features. Each card 232 has a unique bar code that could be activated and programmed into the control system in the same fashion as an RFID tag. In other words, the RFID tag ID and the bar code would then be recognized by the spa control system; this code allows a certain behavior of the spa system. [0034] The biometric scanner is somewhat different in that a finger or eye cannot be left in place by the spa user during spa use. In that case, a control system timer may be started (e.g., 2 hours, 4 hours, 6 hours, etc.) that would allow the spa to function during for that time after a successful biometric scan. The use of such a timer may also be employed with other types of personalized information bearing devices, including the RFID tag and the encoded card. Multiple unique fingerprint or retinal scans could be authorized to activate features of the spa system. [0035] FIG. 5 illustrates an overall block diagram of an exemplary embodiment of a spa system 200 . The system includes a spa tub or receptacle 202 for bathing water, and a control system 212 to activate and manage the various parameters of the spa. Connected to the spa tub 202 through a series of plumbing lines 113 are pumps 104 and 105 for pumping water, a skimmer 112 for cleaning the surface of the spa, a filter 120 for removing particulate impurities in the water, an air blower 106 for delivering therapy bubbles to the spa through air pipe 119 , and an electric heater 103 for maintaining the temperature of the spa at a temperature set by the user or control system. The heater 103 in this embodiment is an electric heater, but a gas heater can be used for this purpose also. Generally, a light 107 is provided for internal illumination of the water. [0036] Service voltage power is supplied to the spa control system at electrical service wiring 115 , which can be 120V or 240V single phase 60 cycles, 220V single phase 50 cycles, or any other generally accepted power service suitable for commercial or residential service. An earth ground 11 6 is connected to the control system and there through to all electrical components which carry service voltage power and all metal parts. Electrically connected to the control system through cable 109 is the control panel 212 . All components powered by the control system are connected by cables 114 suitable for carrying appropriate levels of voltage and current to properly operate the spa. [0037] Water is drawn to the plumbing system generally through the skimmer 112 or suction fittings 11 7 , and discharged back into the spa through therapy jets 11 8 . [0038] An RFID sensor or reader 220 is connected to the control system 212 to provide a sensor signal which indicates whether the RFID tag 222 is within a localized spa area. As discussed above, the sensor 220 may be replaced or supplemented with a card key scanner 230 or biometric scanner 240 . [0039] The particular equipment for a spa installation will depend on the particular implementation, and not all devices illustrated in FIG. 5 may be installed for some implementations. [0040] FIG. 6 illustrates an exemplary method 300 employing RFID control with a bathing installation such as a spa or hot tub. At 302 , one or more unique RFID tags are supplied to a user, e.g. with the spa. At 304 , the user brings the RFID tag in range of the RFID sensor or reader device installed in the spa control system, and the unique code of the RFID tag is read and provided to the spa controller. At 306 , the spa controller determines whether the spa has settings for the RFID tag. If not, the user sets the spa equipment to the desired states at 308 . For example, the settings for heat, air pumps, lights, and blower may be set by the user as desired. The user will then execute a button sequence at 31 0 to instruct the spa controller to synchronize the spa equipment settings with the RFID tag. These settings are stored in memory in association with the code or identification data of the RFID tag. [0041] If at 306 , the spa controller has stored settings associated with the RFID tag, then at 312 , the controller will initiate various functions based on the specific RFID tag and its stored settings. At 314 , the spa tub cover lock is unlatched by the spa controller, and at 318 , the cover alarm (if the spa installation is equipped with a cover and alarm) is disarmed. At 320 , the spa control panel is unlocked for use. At 322 , the user can turn on the desired spa associated equipment, e.g., lights, pumps, blowers, misters etc. [0042] Still referring to FIG. 6 , now consider that a different RFID tag with its own unique code is brought into range of the RFID sensor at 330 . If the controller determines at 332 that another RFID tag is already in range of the RFID sensor, the controller will ignore subsequent RFID tags that may come into range of the sensor. If at 332 , no other RFID tags are in range, operation proceeds to 306 . [0043] At 336 ( FIG. 6 ), the original RFID tag is taken out of range of the RFID sensor. If the controller determines at 338 that another RFID tag is within range of the sensor, operation proceeds to 332 . If no other RFID tag is within range, then at 340 , the spa controller shuts down unnecessary equipment, e.g., spa lights, pumps, blowers and misters. At 342 , the spa tub cover lock is engaged, and at 344 the cover alarm is armed after a predetermined time period or after the cover is locked. At 346 the spa control panel is locked electronically to prevent use or changes in settings. At 348 , the yard lighting associated with the spa is shut down after a predetermined time period, e.g. a delay which allows the user to walk from the vicinity of the spa to the nearby residence, or to exit a gate associated with the spa. [0044] FIG. 7 illustrates an exemplary method 400 employing bar code or other optical or magnetic code control with a bathing installation such as a spa or hot tub. At 402 , one or more unique code cards are supplied to a user, e.g. with the spa. At 404 , the user inserts the card into the card reader installed in the spa control system, and the unique code of the card is read and provided to the spa controller. At 406 , the spa controller determines whether the spa has settings for the inserted card. If not, the user sets the spa equipment to the desired states at 408 . For example, the settings for heat, air pumps, lights, and blower may be set by the user as desired. The user will then execute a button sequence at 410 to instruct the spa controller to synchronize the spa equipment settings with the inserted card and its code. These settings are stored in memory in association with the code or identification data of the inserted card. [0045] If at 406 , the spa controller has stored settings associated with the inserted card, then at 412 , the controller will initiate various functions based on the specific inserted card and its stored settings. At 414 , the spa tub cover lock is unlatched by the spa controller, and at 416 , the cover alarm (if the spa installation is equipped with a cover and alarm) is disarmed. At 418 , the spa control panel is electronically enabled or unlocked for use. At 420 , the user can turn on the desired spa associated equipment, e.g., lights, pumps, blowers, misters etc., allowing the spa to be controlled manually if desired by the user. [0046] Still referring to FIG. 7 , now consider the event that a different card with its own unique code is placed in the card reader at 422 . If the controller determines at 424 that the spa is already in use, and the controller has settings for the different card, the controller will change the spa settings to those programmed for the new card code. If at 424 , no other card is in use or the controller does not have settings for the different card, operation proceeds to 406 . [0047] At 428 ( FIG. 7 ), the original card is removed from the card reader. If the controller determines at 430 that the card has been replaced with another card, operation proceeds to 424 . If the original card has not been replaced in the reader, then at 432 , the spa controller shuts down unnecessary equipment, e.g., spa lights, pumps, blowers and misters, after a predetermined time delay. At 434 , the spa tub cover lock is engaged, and at 436 the cover alarm is armed after a predetermined time period or after the cover is locked. At 438 the spa control panel is locked electronically to prevent use or changes in settings. At 440 , the yard lighting associated with the spa is shut down after a predetermined time period, e.g. a delay which allows the user to walk from the vicinity of the spa to the nearby residence, or to exit a gate associated with the spa. [0048] FIG. 8 illustrates an exemplary method 500 employing a finger print or other biometric scanner with a bathing installation such as a spa or hot tub. At 502 , the end user's existing stored biometric information is used to startup the spa. The user places his or her fingertip or other unique biometric feature on or near a biometric scanner installed at the spa installation. At 506 , the spa controller determines whether the spa has settings for the scanned biometric information. If not, the user sets the spa equipment to the desired states at 508 . The user will then execute a button sequence on the spa control panel at 51 0 to instruct the spa controller to synchronize the spa equipment settings with the user's scanned biometric data. These settings are stored in memory in association with the user's biometric data scanned at 504 , for use the next time the user attempts to use the spa. In an exemplary embodiment, a security feature will be applied, to control the number or identity of persons allowed to store their biometric data in the spa controller. That feature may be set for a limited period of time, or disabled completely, by an authorized user. For example, an authorized user may enter a command, opening the spa to entry of new users, for a limited time, after which time, new users are blocked for entering biometric data as an authorized user. [0049] If at 506 , the spa controller has stored settings associated with the scanned biometric data, then at 512 , the controller will initiate various functions based on the specific inserted card and its stored settings. At 514 , the spa tub cover lock is unlatched by the spa controller, and at 516 , the cover alarm (if the spa installation is equipped with a cover and alarm) is disarmed. At 518 , the spa control panel is electronically enabled or unlocked for use. At 520 , the spa associated equipment, e.g., lights, pumps, blowers, misters etc. that are associated with the stored biometric data are activated by the controller. The user can also set the spa to other settings if desired, since the control panel has been unlocked for use. [0050] Still referring to FIG. 8 , now consider that a different user places his finger tip or other biometric feature on or near the biometric scanner at 530 . If the controller determines at 532 that the spa installation is already in use, the controller will change the spa settings to those programmed for the different user, at 534 . If at 532 , the spa is not in use, operation proceeds to 506 . [0051] At 540 ( FIG. 8 ), one of the initial users initiates another biometric scan. At 542 , the controller queries the user (by interaction using the control panel, e.g. a display and control buttons, for example) to determine if the user wishes to shut down the spa. If the response is negative, the spa installation will continue to run for the duration of a time allotment, either one which is predetermined, or set by the user, and then shut down. If the user does want to shut down the spa operation, then at 546 , the spa controller shuts down unnecessary equipment, e.g., spa lights, pumps, blowers and misters, after a predetermined time delay. At 548 , the spa tub cover lock is engaged, and at 550 the cover alarm is armed after a predetermined time period or after the cover is locked. At 550 the spa control panel is locked electronically to prevent use or changes in settings. At 552 , the yard lighting associated with the spa is shut down after a predetermined time period, e.g. a delay which allows the user to walk from the vicinity of the spa to the nearby residence, or to exit a gate associated with the spa. If no biometric scans are performed within a time period, either preset or programmed by the user, then the controller will shut down non-essential operations of the spa. [0052] FIG. 9 is a flow diagram illustrating a method 600 utilizing an RFID tag for facilitating tracking of a spa or hot tub during and following production. The RFID tag may be attached to the hot tub and information about that item stored in the tag (order number, part number, serial number, date code, etc.). The RFID tag may be the same RFID tag which will be used to control access to the spa once it is installed, or it may be a different tag. The RFID tag travels with the hot tub or spa during production ( 602 ). Features can be added to the hot tub or hot tub and programmed into the configuration ( 604 ). Once the hot tub is completed, it may be counted, and identified by its RFID tag ( 606 ). Shipping information can be generated by scanning the RFID tag ( 608 ). [0053] Although the foregoing has been a description and illustration of specific embodiments of the subject matter, various modifications and changes thereto can be made by persons skilled in the art without departing from the scope and spirit of the invention as defined by the following claims.

A bathing installation system includes a water receptacle, a plurality of electrically powered devices, and an electronic control system adapted to control operation of the devices. A sensor senses the presence of a personalized mobile information bearing device, the sensor having an output signal coupled to the electronic control system for indicating the sensed presence or absence of the mobile device. The electronic control system is responsive to the sensor output signal to be placed in a first state when the sensor signal indicates the sensed presence of the mobile device, and to be placed in a second state when the sensor signal indicates the absence of the mobile device.

[0001] The present invention relates to a process for the separation and isolation of biologically active substances from dairy by-product or secondary waste flows. Many dairy industrial processes, such as in the manufacture of butter and butter concentrates, caseins and caseinates, cheeses, creams, ultra-fresh dairy products, and the like, generate significant amounts of currently unavoidable by-products or waste products. These products must be handled according to legislation that is becoming ever stricter, which often implies a non-negligible cost. One way of recovering that extra cost that the industrialist has to pay, is by attempting to exploit or to find some value added material within the waste or by-product. Unfortunately, such cases are relatively rare on the whole, since the economics of any extra processing steps necessary to retrieve the material are generally unfavorable with respect to value that can be gained from such material. This is especially true of the food and dairy industry, where industrial costs have to be kept as low as possible, in order to maintain economic viability of the general food production processes. Generally speaking, by and waste products of the food industry are handled in the following manner: separation from the by-product or waste product of all solid, or soluble, mineral or organic matter using classical effluent treatment technology such as sedimentation tanks or other related techniques; drying to a greater or lesser degree, in order to eliminate the liquid fraction and only retain the solid fractions in one or several steps. This or these step(s) is (are) extremely costly, in view of the overall consumption of energy involved; fractionating the remaining waste, typically via chromatography, an expensive technique used to find several kinds of very specific molecules for which niche markets exist that can support the increased cost of production. [0005] In many cases, however, little or no value-added exploitation can occur, either because the by-product or waste product has a too low concentration in dry matter, or on the other hand, because the waste or by-product is extremely unstable and perishable, and thus unsuitable for storage for a time sufficient to retreat it. [0006] An example of a branch of the food industry faced with such difficulties is that relating to cheese product manufacture and treatment. Most dairy products start out from a bulk volume, low cost, starting material, namely milk. This starting material is available in very large quantities and the initial transformation steps, such as protein precipitation, filtration, or heat treatment are considered to form part of the well established economic environment in this field, simply because of the immense volumes involved. However, other products and by-products can also be made starting from milk. One such by-product is whey, which again can be transformed into further value added products. Exemplary value added products obtained from whey would be, for example, whey proteins, whey protein concentrate or hydrolysate, β-lactoglobulin, and α-lactalbumin, phosphopeptides, casein proteins, caseinomacropeptides, immunoglobulins and the like. Unfortunately, these further processing steps are not viable on a large scale, simply because of the high cost of the further technological steps that are currently required to produce these products. [0007] Typically, the processes used in creating value-added products from milk waste or by-products goes through whey, separated from the curds of the milk. Two major techniques are used today: filtration, including microfiltration, ultrafiltration, and nanofiltration finer separation techniques such as chromatography or electrophoresis. [0010] In these cases, chromatography is generally considered by far the best in terms of pure performance, and is used for the recovery of molecules such as lactoferrin, lactoperoxydase, glycomacropeptides ou simple fragments thereof. In view of the expense of such relatively small scale techniques, most of the applications envisaged are niche markets, such as infant nutrition formulas, sport nutrition formulas, body building formulas, and specialized dietary supplements for the aged. [0011] From the above, one can conclude that there is a long felt need in general to provide a large scale or scalable, cost effective, means of treating industrial dairy waste or by-product flows in order to provide an economic way of dealing with such waste or by-product, whilst at the same time providing a value added substance that has other significant applications. [0012] One object of the present invention is therefore to provide such a low cost, industrially scalable method for the isolation of biologically active substances from by-product or waste flows. Another object of the invention is to provide for biologically active substances obtained via such a method. [0013] Still yet another object of the present invention is to provide for a biologically active complex in which a biologically active substance obtained via the method of the present invention is used. [0014] Other objects may become apparent through the reading of the description and claims. [0015] In the following specification and claims, the following terms have the meaning assigned to them here below: “by-product or waste flow” is a substantially liquid fraction that is generated during the different steps of industrial dairy processing of a product, and in particular a cheese product; “substantially liquid” means that the fraction contains at most 30% by weight of dry matter; “biologically active substance” means any chemical entity that has an overall physiological effect on the subject to which it is administered; “biologically active complex” means the association of one or more biologically active substances, as defined above, with a support vehicle, that may or may not have an overall physiological effect on the subject to which it is administered in addition to the biologically active substance; “solid support material” is a natural or synthetic insoluble mineral based solid, that is chemically inert, and having molecular adsorptive capacity. Such a material can be present as a powder, granules, flakes, or chips. Suitable supports can be chosen from kaolins, kaolinic clays, montmorillonites, bentonites, bentonitic clays, attapulgites, and the like. [0021] Particularly preferred solid support materials can be chosen from the group consisting of: Kaolin commercially available from Sigma Green clay commercially available from Argiletz; Clarsol STF, Clarsol KC1, Clarsol KC2, Clarsol ATC Na, all available from CECA, France; Kaolin Arvolite SP20, Kaolin 7 ASP20, Kaolin Berrien B SP20, Kaolin Laude SP20, all available from Denain Anzin Minéraux, France; Sialite, Metasial, Sokalite, all available from Soka, France; Kaolin K13 available from Sika, France. [0028] Accordingly, one object of the invention is a method for the isolation of at least one biologically active substance from an industrial dairy by-product or waste flow, comprising: selecting at least one industrial dairy waste or by-product flow containing at least one biologically active substance; bringing the at least one industrial dairy waste or by-product flow into contact with at least one solid insoluble support material for sufficient time to cause the at least one biologically active substance to selectively adsorb on said support material; recovering the insoluble solid support material carrying the adsorbed at least one biologically active substance. [0032] Preferably, the at least one industrial dairy waste or by-product flow is substantially liquid. [0033] Even more preferably, the at least one industrial dairy waste or by-product flow comprises not more than 30% by weight of dry matter. In accordance with the present invention, the at least one industrial dairy waste or by-product flow is preferably generated or supplied from an industrial process that processes or manufactures a product derived from milk. This means that the method of the present invention can be used for treating waste flows and by-products from a number of dairy industries, and more particularly from the group of industries consisting of butter and butter concentrate manufacture, cream manufacture, ultra fresh dairy products, casein and caseinate manufacture, cheese manufacture, and the like. Such processing plants produce huge volumes of liquid or semi-liquid waste or by-product flows, in which many biologically active substances can be found. Most preferably, however, the at least one industrial dairy waste or by-product flow is milk or derived from milk. The milk industry produces huge amounts of liquid waste or by-products such as whey, that contain very interesting biologically active substances, but which with todays current processing techniques require great efforts to isolate and recover them, at great expense, with the result that the products thereby obtained can only be sold in niche markets with perceived high added value. The method of the present invention manages to solve this problem by producing a workable, industrially scalable alternative, that is also very economic, both in the components used, as in the installation and running requirements. Consequently, in one of the most preferred embodiments, the at least one industrial waste or by-product flow is whey. [0034] In yet another preferred embodiment, the at least one solid insoluble support material and the at least one industrial dairy waste or by-product flow are agitated together after being brought into contact one with the other. The conditions of operation will depend on the type and molecular weight of active substance being recovered from the waste flow. Such conditions can be determined by one skilled in the art, so as to arrive at a system where one can scan a waste product flow for all possible biologically active molecules of interest, and then adapt the adsorption conditions, in a further cycle for example, to retain only those specific molecules that are desired. [0035] The method of the present invention can, for example, be made to function as a small plug-in unit that is connected to the main processing flows of the industrial plant and produces a value added secondary or tertiary material with potential applications in human and animal health and nutrition. In addition, the method of the invention reduces the volumes that need to be dried subsequent to isolation of the biologically active substance, thereby causing further economies of scale to be obtained in heating and energy costs. [0036] The unit can for example comprise a chamber, having a solid support material inlet, and a conduit either for the introduction, or the flow through, of the at least one waste flow or by-product. The chamber can also optionally be provided with agitation means, and temperature regulation means. Naturally, the chamber will also be provided with outlets for both the adsorbed biologically active substance/support material complex, and the remaining waste liquid that is now poorer or depleted in molecules of interest and can either be passed through the chamber once again, or dispatched for disposal. In an industrial plant, one could easily foresee the provision of several cycles through the unit, or the provision of multiple chambers, operating in cascade or parallel, each having a different set of operating conditions to specifically adsorb, and optionally specifically desorb any given biologically active substance from the at least one solid insoluble support material. A final optional step, but one that may be advantageous for the preparation of pharmaceutical, or human or animal health preparations, is the isolation of the at least one biologically active substance from the at least one solid insoluble support material. This can be achieved by the desorption step for example, or could be followed by other refining or purifying techniques that are known to the skilled person such as chromatography. [0037] The invention also therefore provides for a method of screening industrial dairy waste or by-product flows for new biologically active molecules of interest. [0038] Preferably, the at least one biologically active substance is selected from the group consisting of hormones, proteins, peptides, polypeptides, antibodies, glycoproteins, glycosaminoglycans, and enzymes. Even more preferably, the at least one biologically active substance has a biological activity selected from the group consisting of antibiotic, probiotic, anti-microbial, anti-fungal, cell growth regulation, neurogenerative, oestrogenic, anti-thrombotic, anti-viral, free radical and metal ions scavengers, immuno-modulatory, anti atherogenic, anti-inflammatory. [0039] A further object of the invention, is the provision of a complex obtainable from a process as defined previously, wherein the complex comprises at least one solid insoluble support material on which is adsorbed at least one biologically active substance. The complex preferably has a biological activity selected from the group consisting of antibiotic, probiotic, anti-microbial, anti-fungal, cell growth regulation, neurogenerative, oestrogenic, anti-thrombotic, anti-viral, free radical and metal ion scavengers, immuno-modulatory, anti atherogenic, anti-inflammatory. [0040] Still yet another object is an animal feedstock composition comprising a complex as defined previously. In a most preferred embodiment, the complex has antimicrobial activity. In this way, the complex can be used as a substitute for feedstocks that currently contain antibiotics and which will soon be forbidden for use in agricultural animal nutrition. The antimicrobial activity of the feedstock of the present invention will act as a therapeutic solution to minor infections that some agricultural animals tend to suffer from, e.g. poultry, pigs, sheep and cattle, but is also applicable to domestic animals, and aquaculture, i.e. the farming of molluscs, crustaceans, shell animals, and fish. [0041] Finally, it is most preferred that the at least one biologically active substance be a substance naturally present in the at least one industrial waste or by-product, i.e. that it not be a substance that has resulted from the addition by man to the mainstream product or to the animal that created the starting materials for the mainstream product. This of course extends to substances that are introduced by genetic manipulation. BRIEF DESCRIPTION OF THE FIGURES [0042] FIG. 1 represents Coomassie Blue stained SDS PAGE runs of proteins of interest in whey adsorbed onto and desorbed from a selection of solid support materials in accordance with the method of the present invention; [0043] FIG. 2 represents Coomassie Blue stained SDS PAGE runs of proteins of interest in whey adsorbed onto and desorbed from a selection of solid support materials different to those of FIG. 1 ; [0044] Where the following meaning is given to the symbols in the FIGS. 1 and 2 : [0045] In FIG. 1 , E=the initial sample, M=a molecular weight marker, T=control, adsorption conditions: 1=STF, 2=KC1, 3=KC2, 4=ATC Na; desorption conditions: 5=STF, 6=KC1, and 7=KC2; [0046] In FIG. 2 , E=initial sample, adsorption conditions : 1=sialite, 2=metasial C, 3=sokalite powder; desorption conditions: 4=sialite, 5=metasial C, 6=sokalite powder; [0047] FIG. 3 is a schematic representation of the implementation of the process of the invention in an industrial environment. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0048] The invention will be further described and explained by the following examples, that are given for the purposes of illustrating some of the preferred embodiments of the present invention, in particular in relation to the recovery of biologically substances of interest from the well known agro-industrial by-product known as whey. EXAMPLES Example 1 [0000] Whey Preparation [0049] The control whey is obtained from fermented milk (Ribot milk™, sold by BRIDEL, France), and simulates whey obtained from cheese manufacturing plants during the manufacture of fresh cheese from cow's milk or certain cow's milk based soft cheeses. [0050] The fermented milk is centrifuged at 6000 g for 20 minutes. The precipitate obtained, that is made up mainly of caseins and caseinates, was eliminated ; the supernatant was collected and made up the control whey sample. [0051] Two types of fermented milk were used [0052] 1. low fat type (low in fats); [0053] 2. whole fat or creamy (rich in fats). [0054] The pH of each whey obtained was measured and found to be approximately pH 4.6. [0055] For some of the examples, the pH was adjusted to pH 6.8, by the addition of 0.5M aqueous sodium hydroxide NaOH, in order to simulate sweet whey, and in order to limit the effects of dilution of the starting material. Other aqueous hydroxides could also be optionally be used instead of NaOH, but the latter is most often used in the milk industry. [0056] Unless indicated otherwise, 25 millilitres of each whey was taken as the starting material, and the solid support material concentration was 2% (w/v). After addition of the support material to the whey, the mixture was agitated, for example on an agitation table, for an hour. [0057] The mixture was then filtered on a Büchner filter, using a Whatman #4 filter paper. The solid and liquid fractions obtained after filtration were stored at −20° C. for further analysis. [0058] The various different solid support materials used were as follows in Table 1: TABLE 1 Product Name Supplier Number kaolin Sigma 1 Argile verte Argiletz 2 Clarsol STF CECA 3 Clarsol KC1 CECA 4 Clarsol KC2 CECA 5 Clarsol ATC Na CECA 6 Kaolin Arvolite Denain Anzin 7 SP20 Minéraux Kaolin 7 ASP20 Denain Anzin 8 Minéraux Kaolin Berrien B Denain Anzin 9 SP20 Minéraux Kaolin Laude Denain Anzin 10 SP20 Minéraux Sialite SOKA 11 Metasial C SOKA 12 Sokalite poudre SOKA 13 Kaolin K13 SIKA 14 Biochemical Analysis [0059] The solid support materials that were tested, either with or without prior treatment, are brought into contact with a solution that simulates an agroindustry effluent or by-product that contains one or more biologically active substances of interest. [0060] Insofar as the experimental parameters are concerned, for example, contact times, type and degree of agitation, etc., these are adjusted to in order to modulate the adsorption and selectivity of the solid insoluble support material for the biologically active substances of interest. After solid-liquid separation, two fractions are obtained 1. a solid fraction comprising the solid support material that is more or less loaded with biologically active substances of interest, and particularly with proteins ; and 2. a liquid fraction that has a lower protein content. [0063] The obtained fractions are analysed using a gel electrophoresis technique known as SDS-PAGE, which involves separating out proteins based on their respective molecular masses, followed by staining. The SDS-PAGE technique enables identification of all of the proteins present in a given sample and provides a visualisation of their distribution in each fraction, when compared to the starting sample analysed. The liquid fraction can be analysed as it is after the solid-liquid separation step, i.e. directly after adsorption. The solid fraction, on the other hand, is put into solution with what is known to the skilled in the art as a “loading” buffer, and brought to the boil. Such drastic conditions enable all of the adsorbed proteins to be desorbed, but are not representative of the enzymatic or temperature conditions prevalent in the normal digestive tract, rumen or stomach. In the figures, the dotted line delimits two areas, with the proteins of interest being located in the area above the dotted line. In the examples given, these proteins are substantially immunoglobulins and lactoferrin. The area below the dotted line is that in which unwanted residual caseins and low molecular weight proteins such as α-lactalbumin and β-lactoglobulin are to be found, which have molecular weights at about 16 to 18 kDa. These latter kind of molecules are not of interest in the present invention. [0064] SDS-PAGE method and analysis conditions. [0065] The following stock solutions were used [0066] Denaturing buffer 5×(5 mL) SDS 10% (500 mg) β-mercaptoethanol 25% (1.25 mL) Bromophenol blue 0.1% (2 mg) glycerol 15% 750 mg QSP 5 mL H 2 O [0072] Separation buffer, or lower buffer, (50 mL) TRIS 9.075 g SDS 0.2 g QSP H 2 O 50 mL Adjust pH to 8.8 avec Hcl 1M [0077] Concentration buffer or upper buffer (25 mL) TRIS 1.5 g SDS 0.1 g QSP H 2 O 25 mL Adjust pH to 6.8 avec HCl 1M [0082] Migration buffer 10X (200 mL) TRIS 6 g Glycine 28.8 g SDS 2 g QSP H 2 O 200 mL [0087] APS 10% (1 mL) APS (ammonium persulfate powder) 100 mg QSP H 2 O 1 mL [0090] The polyacrylamide gels were prepared as follows: Separation Gel 10% Acrylamide 30% 3.3 mL TRIS HCl pH 8.8 2.5 mL H2O 4.1 mL APS 10% 40 L Temed 3 L Concentration Gel 4% Acrylamide 30% 0.67 mL TRIS HCl pH 6.8 0.63 mL H 2 O 3.6 mL APS 10% 50 μL Temed 5 μL [0091] The samples were adjusted to a total protein concentration of approximately 1 mg/mL, by the addition of a volume of loading buffer i.e. sufficient to obtain a concentration that is ready to load of 1 mg/mL. The volume actually loaded onto the gel was comprised between about 25 μl and about 30 μL per well. [0092] Electrophoresis was carried out under the following conditions concentration gel at 60V, then separation gel at 190 V, with migration lasting approximately 45 minutes. After migration was stopped, the gels were stained with Coomassie blue and then dried. Example 2 [0093] The sample used was a low fat whey, the pH of which had been adjusted to between 4.6 to 6.8 by the addition of 0.5 M NaOH. The results for the solid insoluble support materials 3, 4, 5 and 6 are given in FIG. 1A , with lanes 1, 2, 3 and 4 representing adsorption, and lanes 5, 6, 7 and 8 respectively representing desorption. [0094] The four solid insoluble support materials tested all had high adsorptive capacity, cf. A1, but especially A2, A3 and A4. However, desorption, even under drastic conditions, was low, cf. A5 to A8. Support number 4, a clarsol KC1 did show a slight difference in the desorption profile compared to the others, the uppermost band being separating out slightly higher, which indicated the desorption of a protein of higher molecular mass. Example 3 [0095] The sample tested was a whole fat whey, the pH of which was adjusted to between 4.6 to 6.8 by the addition 0.5M NaOH. The results of solid insoluble supports numbered 3, 4, 5 and 6 are given in FIG. 1B , with adsorption being represented in lanes 1, 2, 3 and 4, and desorption being represented in lanes 5, 6, 7 and 8 respectively. A few significant differences can be seen depending on the nature of the solid insoluble support material, in particular for KC1 (B2) and KC2 (B3). For KC1 (support n°4), one can see that the bands corresponding to a low molecular weight have disappeared, when compared to the adsorption of this protein on the support in B2. For KC2 (support n°5), this result is also observed, but further included the absorption of a high molecular weight protein, since the band that was visible in B3 also disappeared. Adsorptive capacity is thus generally low under these experimental conditions, with little or few differences between the initial sample in E and lanes B1 to B4. To summarize, adsorptive capacity is low, but despite this, a slight difference in the profiles between clarsols KC1 and KC2 is noticed, with certain bands appearing to be more intense than for the two other supports B6 and B7. Example 4 [0096] The sample used was a low fat whey, the pH was not adjusted and was naturally close to 4.6. The results of solid support materials 3, 4, 5 and 6 are given in FIG. 1C , with adsorption being represented in lanes 1, 2, 3 and 4, and desorption being represented respectively in lanes 5, 6, 7 and 8. Here one can observe that adsorption differs greatly depending on the solid insoluble support material used. It is low for STF (C1), medium for KC1 and ATC Na (C2 and C4) and strong for KC2, in which there is almost complete disappearance of the bands, as shown in C3. Desorption, on the other hand, is very high for KC2 (C7), with the presence of a single very intense band in the upper area, indicating a very high selectivity upon desorption, and intermediate for KC1(C6) and finally relatively weal for STF and ATC Na (C5 and C8). The difference in behaviour upon desorption appears to be linked to the degree of adsorption that took place beforehand. As has been shown, depending on the final experimental parameters used, adsorption, desorption and corresponding selectivity can be modulated greatly. The four solid insoluble support materials all behave in a generally similar way. However, clarsol KC1 and especially clarsol KC2 show some noticeable differences in behaviour, which are visible both after adsorption (B2, B3 and C3) and desorption (B6, B7 and C7). Example 5 [0097] The sample used was a low fat whey, the pH of which had been adjusted to about 4.6 to 6.8 by the addition of 0.5 M NaOH. [0098] The results of support materials numbered 11, 12 and 13 are presented in FIG. 2A , with adsorption being represented by lanes 1, 2 and 3 respectively, and desorption being represented by lanes 4, 5 and 6. The three support materials tested all demonstrated a high adsorptive capacity (A1, A2 and A3). Desorption, even under extreme conditions, was low (A4, A5 and A6). Metasial C (support n°12) displayed a slight difference in its desorption profile (A6), in that the upper band was slightly higher, indicative of the desorption of a protein with higher molecular weight. Example 6 [0099] The sample tested was a whole fat whey, the pH of which was adjusted to between 4.6 to 6.8 by addition of 0.5M NaOH. The results for support materials 11, 12 and 13 are given in FIG. 2B , whereby adsorption is represented in lanes 1, 2 and 3, respectively, and desorption is represented in lanes 4, 5 and 6. Whichever material was used, no significant difference was observed (B1, B2 and B3). Adsorptive capacity is low under the experimental conditions used, with little difference between the starting sample and lanes B1 to B3. However, the desorptive capacity is good. Despite low adsorption, the desorbed fractions were all enriched (B5, B6 and B7), whereby some bands appeared to be more intense than in the starting material. Here once again, Metasial C (support n°12) showed a slightly different profile (B5), in that some bands appeared to be more intense than for the two other support materials (B4 and B6). Example 7 [0100] The sample used was a low fat whey, the pH was not adjusted and was naturally close to 4.6. The results of support materials numbered 11, 12 and 13 are shown in FIG. 2C , with adsorption being given in lanes 1, 2 and 3, and desorption in lanes 4, 5 and 6 respectively. Adsorption is intermediate when compared to the conditions used in A and B. Many bands are present in the fractions C1, C2 and C3, but are generally of a lower intensity than the starting sample. Desorption is very high (C4, CS and C6), with the presence of a very intense band in the upper area (very high selectivity for the corresponding protein). Under these conditions, no significant difference was observed between the three support materials (C4, Cs and C6). It can thus be concluded that depending on the final experimental parameters used, adsorption, desorption and selectivity can be modulated in an important way. The three support materials behave in a virtually identical manner. However, Metasial C shows some differences in behaviour, that are especially noticeable upon desorption (AS and B5). Example 8 [0000] Microbiology [0000] Sample Selection [0101] The samples of example 7 were those that showed the most interesting desorption profile, with high desorption of proteins having a molecular weight within the target area being searched for. An in vitro test was carried out on these samples to show that the complex obtained had antimicrobial activity. [0000] Mother Culture Preparation [0102] The bacterial strain used was a strain of E. Coli. This strain was maintained in culture in a Luria-Bertani medium having the following composition: bactopeptone 10 g/L, yeast extract 5 g/L, sodium chloride 5 g/L, prepared in purified water. The culture conditions were as follows: temperature 37° C., agitation 250 rpm on an agitating table, period between reseeding: 24 hours. [0103] At T=0 (where T equals time), an aliquot was thawed. Reseeding was carried out at 2% (v/v) in Luria-Bertani medium. At T=24 hours and 48 hours, a further reseeding at 2% was carried out. The culture at T=48 hours was taken for the experiments, since by this time, the culture had reached the exponential growth phase. [0000] Preliminary Tests [0104] The analytical method used was reading from a spectrophotometer at a wavelength of 565 nm. In a non-inoculated medium, one of either whey n°1 or whey n°2 was added, in order to test whether the endogenous bacteria would not develop in these experimental conditions, and thereby lead to inaccurate results. Under the conditions given, no bacterial growth was observed. [0000] Control Experiments [0105] Several control experiments were carried out in addition to the main experiment involving the complex comprising the solid support material and biologically active substance plus seeded medium (A): B) whey+seeded medium : check for antimicrobial activity of whey on its own; C) seeded medium: bacterial growth control D) seeded medium+solid insoluble support material alone effect of the solid support material on its own on bacterial growth; E) solid insoluble support material alone+LB medium: test for an eventual effect of a non-sterile support material; F) complex+LB medium: test for an eventual effect of a non-sterile complex. [0111] In a glass tube with a diameter of 1.7 mm, 0.1 mL (i.e. 2% v/v) of culture was added to 5 mL of LB media placed within the tube. The culture had reached its exponential growth phase (T=0 h). 10 mg of product was added, whereby the product was the complex, or a whey powder, to give a weight of 0.2% (w/v). A collection of tubes prepared in the same way with different solid insoluble support materials was agitated at 250 rpm and maintained at at temperature of 37° C. Optical density measurements were taken at regular intervals, for example after 1, 3, 5, and 22 hours respectively via spectrophotometry, using a wavelength of 565 nm, in order to check for bacterial growth. [0000] Calculation Method [0112] The results given in Table 2 were obtained after subtraction of the optical density of the supports (D-E) or of complex (A-F), in the LB medium and then compared to the control set up (C) and a whey control (B). Only the values for T=5 hours and T=22 hours are shown in the table. The optical densities read at T=1 hour and T=3 hours did not show any significant differences, since they correspond essentially to the beginning of bacterial growth. [0113] Subtraction of the values is necessary, since bacterial concentration is linked to the turbidity of the seeded medium, and in parallel, the addition of the solid insoluble support material also generates some turbidity that needs to be deducted in order to have the optical density that is directly linked to bacterial growth. TABLE 2 Samples OD (T = 5 h) OD (T = 22 h) Growth Control (C) 0.93 1.30 Sialite Support (D-E) 0.11 0.41 Complex (A-F) 0.03 0.08 Metasial C Support (D-E) 0.28 0.61 Complex (A-F) 0.08 0.72 Sokalite powder Support (D-E) 0.05 0.59 Complex (A-F) NA 0.11 Whey control (B) 1.06 1.58 Discussion [0114] Control C shows that in the culture conditions used, a strong rate of bacterial growth was observed. [0115] Control B, obtained by the addition of lyophilized whey powder, shows that, on its own, whey has no inhibiting effect on bacterial growth. On the contrary, the addition of powdered whey seems to have the opposite effect, i.e. stimulate bacterial growth, probably because it is very rich in lactose. [0116] The solid insoluble support materials on their limit microbial growth. At T=5 hours, the results obtained for sialite, metasial C and sokalite powder are respectively 11.8%, 30.1% and 5.4%, compared to the control growth (100%). At T=22 hours, the same measurements gave values of 31.5%, 46.9% and 45.8%. Thus the solid support material on its own has an inhibiting effect on bacterial growth particularly at the beginning of microbial cell growth. [0117] For the complexes formed according to the invention, growth was in general slowed, with an amplified effect. At T=5 hours, the results for the complexes containing sialite and metasial C were respectively 3.2% and 8.6% compared to the growth control (100%). At T=22 hours, these values had reached 6.1%, 55.4% and 8.5% respectively. Although the complex containing metasial C seems to be quite a good inhibitor at the beginning of bacterial growth, the value obtained at T=22 hours would lead one to believe that its inhibitory capacity is in fact similar to that measured for the insoluble solid support alone, and that therefore adsorption of proteins from whey does not lead to increased anti-microbial activity. [0118] However, for sialite and powdered sokalite, strong anti-microbial activity is observed at both T=5 hours and T=22 hours, with an inhibition greater than 90% . Thus the adsorption of proteins from whey, as a waste effluent of the milk industry enables not only amplification of the antimicrobial activity, but also enables this activity to be present for longer, as had been already observed with the solid support materials on their own. [0119] It is thus likely that the complexes formed according to the present invention have bacteriostatic properties. [0000] Further Studies [0000] Selection of the Bacterial Strain [0120] The first set of tests were carried out on a strain known as E. Coli. (gram −). In order to validate the theory behind the invention, other strains were tested. These strains were Staphylococcus Epidermidis (gram +) and Listeria Innocua, the latter often being used to emulate the behaviour of Listeria monocytogenes, but without the precautions necessary to manipulate the monocytogenes strain. [0121] Other tests were carried out to discover the mechanism of action of the complexes according to the present invention, to determine whether the complexes were “concentration dependent” or “time dependent”. [0000] Analytical Method [0122] The results were confirmed through the use of another analytical method, in order to demonstrate that they were not biased by the experimental conditions. Tests were thus carried out on a gelose media, and visible colony counting. [0123] In the same manner, the initial analytical method used was challenged by adopting a different method. The addition of the solid support, or the formation of a particular complex leads to the risk biasing the values obtained. For the concentration of solid support material used and tested, approximately 0.2%, the samples were homogenized by centrifugation at low speed for 5 seconds. For other concentrations, however, for example at 1% concentration, i.e. 50 mg, this simple step was insufficient to obtain a homogeneous sample in which the OD could be said to be representative. The inventors therefore resorted to a visual observation of the turbidity of the samples. [0000] Pilot Scale [0124] As has been mentioned above, the process or method of the present invention is designed to solve the problem of waste, effluent or by-product flows of organic material that are generated in the dairy industry through a industrially economically viable method of recovering biologically active substances from said waste or by-product flows. FIG. 3 shows a schematic representation of how the process according to the present invention can be implemented into an existing industrial food production unit, and more specifically into a cheese manufacture production line. During cheese production, whey is produced as a by-product, generally indicated on FIG. 3 by the reference numeral 1 . The whey is pumped and collected into a storage vessel 3 . The tank 3 also includes agitation means, such as a stirrer 4 , to keep the whey homogenized. The homogenized whey is then pumped through an automatic rotary valve 5 via a centrifugal pump 6 and into a reactor vessel 7 that will enable the selective absorption and desorption of required biologically active substances in accordance with the present invention, and equipped with agitation means, for example, a stirrer 8 . The reactor vessel 7 is connected to a hopper 9 and a metering pump 10 . The hopper 9 is loaded with solid insoluble support material that is added to the reactor vessel 7 via the metering pump 10 . Other means of transporting and feeding the solid insoluble support material, could be for example, by using a conveyor system. The mixture of whey and insoluble solid support material is stirred continuously and at the necessary optimal conditions and length of time required for the desired biologically active substance or substances to be adsorbed onto the solid support material. Once adsorption is complete or has been maximized, the mixture of whey and solid insoluble support material is fed via a centrifugal pump 16 and a automatic rotary valve 17 through an accumulator vessel 18 into a solid/liquid separation system 20 . The accumulator vessel 18 recirculates the mixture, and enables the system to be operated until optimal filtration conditions are reached, thereby ensuring consistency in the results obtained. In the separation system 20 , the solid and liquid phases are separated one from the other, leaving a solid phase that is as dry as possible. It is noted that the solid support material now contains the biologically active substances absorbed onto it. The solid thus produced is then dried using more conventional techniques, such as via a concentrator, evaporator, flash dryer, spray dryer, atomizer and the like. [0000] Pilot Scale Production [0125] The production of several kilograms of active complex was carried out starting from whey originating from a cheese manufacture. Kaolin, available under the tradename Sialite (Soka, France) at 2% w/v, was added to a total volume of approximately 8m 3 whey identical to that mentioned in example 7. Solid-liquid separation was carried out using a press filter. Approximately 160 kg of active complex were recovered for analysis and animal nutrition testing. The whey was tested upon entry into, and exit from, the production process, and the following results obtained: Whey Entry Exit Whey Dry matter (%) 100% 96.7% Fats (%) 100% 50.0% Lactose (%) 100%  100% Total Nitrogen Content (MAT) (%) 100%   84% Casein nitrogen (%) 100%   0% Serum Proteins (%) 100% 90.3% [0126] MAT: total nitrogen content=N*6.38 (where 6.38 is a correction factor specific to milk proteins) [0127] NPN: non-protiein nitrogen (N*6.38*0.97) [0128] NCN non-casein nitrogen (N*6.38*0.98) [0129] MAT−NCN=quantity of casein present, and enables determination of the amount of casein degradation [0130] MAT−NPN=quantity of caseins+serum proteins [0131] NCN−NPN=quantity of serum proteins [0132] An SDS-PAGE analysis of the nature of the proteins retained on the solid support confirmed the result described in example 7. Only high molecular weight serine proteins are adsorbed onto the solid support used. [0000] Animal Studies [0133] A random test on 14 day old Ross breed chickens was carried out for 14 days over a population of 229 individuals, separated into a first group of 114 chickens on a standard dietary regime, and 115 chickens whose standard dietary regime was supplemented with 2% by weight of the active complex obtained above. The diet, which mainly comprised maize (52%), soybean (34%) and wheat (7%), was given to the animals as crumbs ad libitum. Observations and weighings of the chickens were carried out at the start (day 1), and then at days 7 and 14, to determine the general state of health of each group, but also to ascertain the average daily weight gain and a feed efficiency index. [0134] These two parameters are usually considered to be the most important parameters for an industrial evaluation of an animal feed test. The average daily weight gain indicates how much weight the animal puts on and the feed efficiency index indicates how much the animal has put on weight compared to the quantity of food ingested. For a farmer, the idea is to have a minimum quantity of feed to distribute for a maximal weight gain. The product described and produced according to the present invention does just that. Physico-chemical and microbiological analyses of the excreta were also undertaken. [0135] In comparison to the standard dietary regime test group, the tests on the supplemented group of animals showed that during the first week, known as the growth stage, an average daily weight gain increase of +4.2% and a 5.3% reduction of the feed efficiency index were observed. No statistically significant difference was observed for mortality and morbidity rates. The analysis of the excreta showed a reduction in coliform bacteria of −0.5Log CFU/batch of standard food, an increase in dry matter of +12.9%, as well as a reduction in organic matter of −7.9%. [0136] A random test in an industrial pork farm on piglets that were 28 days old was carried out over 14 days and on 74 specimens, split into two groups of 36 and 38 piglets respectively. The group of 36 piglets was put on a standard dietary regime, and the group containing 38 piglets were fed with an active complex 1% by weight supplement to the standard diet. The standard diet for piglets post-weaning was given as granules ad libitum. Observations and weighings were carried out at day 1 and day 14 to determine the general state of health of each group, but also the average daily weight gain and feed efficiency index. Physico-chemical and microbiological analyses of the excreta were also carried out. In comparison to the chickens on the standard diet, the tests showed that over a period of 14 days, an increase in the average daily weight gain of +23.2% and a reduction of the feed efficiency index of −4.0% was observed. No significant statistical difference was observed for the mortality and morbidity rates. Analysis of the excreta showed an increase in dry matter of +53.9%, a reduction in organic matter of −12.9%, as well as a reduction in the total quantity of phosphorus of −33.3%.

The present invention relates to method for the isolation of at least one biologically active substance from an industrial dairy by-product or waste flow, comprising—selecting at least one industrial dairy waste or by-product flow containing at least one biologically active substance;—bringing the at least one industrial dairy waste or by-product flow into contact with at least one solid insoluble support material for sufficient time to cause the at least one biologically active substance to selectively adsorb on said support material;—recovering the insoluble solid support material carrying the adsorbed at least one biologically active substance.

FIELD OF THE INVENTION [0001] The present invention relates to a composition for improving brain function and a method for improving brain function. BACKGROUND OF THE INVENTION [0002] The symptoms and diseases caused by a deterioration of brain function include depression, schizophrenia, delirium, dementia (cerebrovascular dementia, Alzheimer's disease, and the like), and the like. With the aging of the population in modern society, especially the increase in the number of people with dementia is becoming a serious social issue. There are various symptoms observed among individuals with dementia, and symptoms commonly observed among them include dysmnesia, disorientation, decline in judgment and thinking ability, and the like. The forms of dementia which affect especially a large number of individuals are cerebrovascular dementia and Alzheimer's disease. For example, in patients with cerebrovascular dementia, damage to the nerve cells in the cerebral cortex and hippocampus caused by obstruction of the brain blood flow gives a rise to cognitive impairment and dysmnesia. For this reason, in addition to treating pre-existing diseases, such as high-blood pressure, diabetes, and hypercholesterolemia, which may trigger cerebrovascular disorders, drugs which are capable of improving brain blood flow and/or drugs which are capable of protecting brain nerve cells are administered. In the meantime, causes of Alzheimer's disease have not been clearly elucidated; however, since a decrease in the level of acetylcholine, which is a neurotransmitter in the brain, is observed in the patients with this disease, a hypofunction of cholinergic neurons is assumed to be one of the causes (reference 2). Therefore, a therapeutic strategy aiming at preventing the hypofunction of cholinergic neurons by increasing the concentration of acetylcholine has been the mainstream for the treatment of Alzheimer's disease. [0003] Currently, as a therapeutic drug against Alzheimer's disease, acetylcholinesterase inhibitors, for example, such as donepezil hydrochloride, are commercially available. However, the acetylcholinesterase inhibitors, such as donepezil hydrochloride, have their drawbacks that they should not be administered for an extended period of time due to their hepatotoxicity and strong side-effects as well as that they are costly. [0004] Meantime, as a report in regard to peptides showing an anti-amnesic effect, for example, it has been reported that XPLPR (X represents L, I, M, F, or W) (SEQ ID NO:1) demonstrated an improving effect against scopolamine-induced amnesia when administered intracerebroventricularly or orally at 300 mg/kg, and, a release of acetylcholine from the intracerebral C3a receptor has been suggested as one of the mechanisms involved in this effect (reference 1). However, all these peptides need to be administered in a large dose orally, intraabdominally, intracerebroventricularly, or the like in order to demonstrate their actions; therefore, they are not considered to be orally ingestible substances capable of demonstrating a sufficient level of effects. In addition, there has been no report on evaluation of peptides of the present invention and their analogs; therefore, their actions involved in the improvement of brain function have been hitherto unknown. [0005] Thus, with the progress of the aging of the society, demands for development of pharmaceutical agents, which prevent the symptoms and diseases caused by a deterioration of brain function and further demonstrate curative effects on the symptoms and diseases, and for further development of safer compounds which are excellent in food application are becoming increasingly stronger. [0006] Scopolamine is believed to function as a muscarinic receptor antagonist that induces the hypofunction of cholinergic neurons. Working as an inducer of brain dysfunction, scopolamine is used in the production of model animals to be used in the development of therapeutic drugs against Alzheimer's disease. In regard to the prophylactic and/or curative activities against brain dysfunction by the action of scopolamine, their effects may be demonstrated in behavioral pharmacological tests, such as a Y-shaped maze test, an eight-arm maze test, and a passive avoidance test. Further, the effects of improving and/or strengthening brain function may be demonstrated in the same behavioral pharmacological tests with use of normal animals. [0007] Regarding the function of Phe-Pro a hypotensive lowering activity based on ACE inhibitory activity has been reported (reference 3). However no reports evaluated activities of the peptide Phe-Pro in improving brain functions and such activities of these peptides can not be expected. SUMMARY OF THE INVENTION [0008] The present invention provides a composition which may be ingested orally in a small dose for the purpose of improving brain function. Further, the present invention provides a method for improving brain function. Several aspects of the present invention are as follows. [0009] (1) The present invention is a composition for improving brain function, comprising, as an active ingredient, Phe-Pro or a salt thereof. [0010] (2) The present invention is also the composition according to (1), which is for oral ingestion. [0011] (3) The present invention is also a method for improving brain function, the method including administering to a non-human animal Phe-Pro or a salt thereof. [0012] (4) The present invention is also the method according to (3), in which the administering is oral administration. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 shows a prophylactic effect of a peptide Phe-Pro (FP) against scopolamine-induced amnesia. Water (control), scopolamine alone, or 500 nmol/kg weight or 5000 nmol/kg weight of FP together with scopolamine, was administered to mice, and their respective prophylactic effects against amnesia were evaluated in accordance with a method described in Example 1. The vertical axis in FIG. 1 shows the percentage of spontaneous alternation behavior. In order to confirm whether or not amnesia was induced, a significant difference between a water-administered control group and a scopolamine control group to which scopolamine was administered alone was calculated using Student's t-test. ** indicates P<0.01 with respect to the water-administered control group. A significant difference between the FP-administered group and the scopolamine control group was calculated using Student's t-test. # indicates P<0.05 with respect to the scopolamine control group. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0014] The peptide Phe-Pro in the composition of the present invention includes may be chemically-synthesized peptide or a peptide derived from a natural product. For the chemical synthesis of these peptides, a commonly-used method, such as a solid phase synthesis (t-Boc-chemistry or Fmoc-chemistry) and a liquid phase synthesis, may be employed. For example, these peptides may be synthesized using an automated peptide synthesizer, such as the peptide synthesizer (PSSM-8) available from Shimadzu. A method for the peptide synthesis, appropriate reaction conditions, and the like may be selected based on the common general technical knowledge of a person skilled in the art at the discretion of the person. A method for purifying a chemically-synthesized peptide is also well known to those in the art. [0015] As used in the specification, when referring to the peptide Phe-Pro, “Phe-Pro” and “the peptide Phe-Pro” include salts thereof unless otherwise clearly indicated or otherwise obvious within the context that they should be excluded. Examples of such salts include salts, such as sodium salts, potassium salts, and hydrochloride salts, which may exist under physiological conditions. Meanwhile, the composition of the present invention may include other peptide and a free amino acid or a salt thereof, in addition to the peptide Phe-Pro, which is the active ingredient of the composition of the present invention. In relation to the present invention, three-letter codes, single-letter codes, and peptide notation follow the general rules well known to those in the art. [0016] The effect in improving brain function of the composition of the present invention or the peptide Phe-Pro may be confirmed using a system based on an evaluation system for therapeutic drugs against Alzheimer's disease, the system using a Y-shaped maze test, for example. Specifically, a muscarinic receptor antagonist, such as scopolamine, may be used on a rat or a mouse so as to cause a hypofunction of the cholinergic neurons. Then, either the rat or the mouse may be administered with a drug which induces amnesia by causing brain dysfunction alone or together with the composition of the present invention or the peptide Phe-Pro, or alternately the rat or the mouse may be administered, prior to the administration of such a drug, with the composition of the present invention or the peptide Phe-Pro. Then, the mouse or the rat may be subjected to a test using a Y-shaped maze so that the prophylactic actions against amnesia of the composition of the present invention may be confirmed by using the percentage of change in spontaneous alternation behavior to different arms and the total number of entries into the maze as indicators. [0017] In the tests, the negative control may be, for example, an animal received only water. In an experiment to confirm the prophylactic action against drug-induced amnesia of the peptide Phe-Pro, an animal administered only with a drug, which induces amnesia by causing brain dysfunction, such as scopolamine, may be included to be used as a control. [0018] The composition of the present invention includes, as an active ingredient, the peptide Phe-Pro and oral administration or oral ingestion thereof allows achievement of the desired effects described above. The period of administration or ingestion of the composition of the present invention may be variously adjusted upon consideration of the age of a target of the administration or ingestion, such as a human or non-human animal, and the health conditions and the like of the target. Examples of the non-human animal include non-human higher vertebrate animals, particularly non-human animals, including pet animals, such as dogs and cats, and domestic animals, such as cattle, horses, pigs, and sheep; however, the non-human animal is not limited thereto. A single administration of the composition of the present invention is enough to demonstrate its effects; however, a continuous effect may be expected by continuous ingestion, which is once or more a day. The composition of the present invention when used as medicine may be in the form of drugs for oral administration. For example, the form may be a tablet, a pill, a hard capsule, a soft capsule, a microcapsule, a powder, a granule, a liquid, or the like. When produced as medicine, the composition of the present invention may be produced in a unit dose required for commonly-approved drug administration by, for example, including a pharmaceutically approved material, such as a carrier, an excipient, a filler, an antiseptic, a stabilizer, a binder, a pH modifier, a buffer, a thickener, a gellant, a preservative, and an antioxidant, accordingly as needed. [0019] The composition of the present invention may also be used as a material for food and beverage or a material for animal feed. For example, the composition of the present invention or the peptide Phe-Pro which is the active ingredient of the composition of the present invention, may be considered a functional food, such as a food for specified health use, which is effective in improving brain function. [0020] The dose of administration or ingestion of the present composition or the peptide Phe-Pro is preferably 0.1 mg/kg weight to 10 mg/kg weight per administration or ingestion in general in order to obtain desired effects, in terms of the amount of the peptide Phe-Pro which is the active ingredient. The dose per ingestion in a food, which is, for example, a functional food, may also be lowered further than the above-described level, depending on the number of ingestions per day. An appropriate dose of ingestion may be further adjusted upon consideration of various factors as described above. [0021] The nutritional balance, flavors, and the like of a food, such as a functional food, including the composition of the present invention or the peptide Phe-Pro which is the active ingredient of the composition, may be improved by addition of an additive either: made of other ingredient used in food, such as a saccharide, a protein, a lipid, a vitamin, a mineral, and a flavor, which include various carbohydrates, lipids, vitamins, minerals, sweeteners, flavoring agents, coloring agents, texture enhancers, and the like, for example; or made of a mixture thereof. Animal feed containing the composition of the present invention or the peptide Phe-Pro which is the active ingredient of the composition, may be prepared similarly to food for human consumption. [0022] For example, the above-described functional food may have the form of a solid, a gel, or a liquid, may be in the form of, for example, any one of various processed foods and beverages, dry powder, a tablet, a capsule, a granule, and the like, and, further, may be any of various beverages, yogurt, a liquid food, jelly, a candy, a retort pouch food, a tablet confectionary, a cookie, a sponge cake, bread, a biscuit, a chocolate, and the like. [0023] When a functional food, such as a food for specified health use, containing the composition of the present invention is manufactured, although depending on how the composition has been added and how the food containing the composition is served as a product, the functional food is prepared so that the amount of the peptide Phe-Pro which is the active ingredient of the composition, to be contained in 100 g of the final product may be 1 μg to 10 g, preferably 10 μg to 1 g, more preferably 100 μg to 100 mg. [0024] The composition of the present invention or the peptide Phe-Pro which is the active ingredient of the composition, may improve brain function, thereby being capable of preventing amnesia and strengthen memory. Further, the composition of the present invention or any one of the above-described peptides, which is the active ingredient of the composition, may also be used for treatment or prevention of the symptoms and diseases caused by a deterioration of brain function, the symptoms and diseases including depression, schizophrenia, delirium, dementia (cerebrovascular dementia, Alzheimer's disease, and the like), and the like. [0025] Hereinafter, the present invention will be specifically described by way of Examples; however, the scope of the invention is not limited to Examples. EXAMPLES Example 1 Prophylactic Activity of Phe-Pro Against Amnesia [0026] Male mice (n=15) of the ddY strain (approximately 7-week old) were used, and they took food and water ad lib. Test substances used were 500 mol/kg weight (130 μg/kg weight) or 5000 nmol/kg weight (1300 μg/kg weight) of FP. The test substances were administered to the mice once orally 60 minutes before the execution of a Y-shaped maze test for evaluation of spontaneous alternation behavior. Further, 30 minutes before the execution of the Y-shaped maze test, 1 mg/kg weight of scopolamine was subcutaneously administered on the backs of the mice in order to induce brain dysfunction (dysmnesia and/or cognitive impairment) in the mice. In the Y-shaped maze test, a Y-shaped maze was used as an experimental device, in which the length of each arm was 40 cm, the height of the wall was 12 cm, the width of the floor was 3 cm, and the width of the upper part was 10 cm, and three arms were connected to each other at an angle of 120 degrees. Each of the mice was placed at the tip of any one of the arms of the Y-shaped maze, and then let go to freely explore in the maze for 8 minutes. The sequence of the arms each of the mice entered was recorded. The number of entries by each of the mice for each of the arms during the measurement time was counted to be the total number of entries. In the sequence, the combination in which three different arms were selected in succession (for example, with the three arms respectively called A, B, and C, if the sequence of the arms entered is ABCBACACB, the count is 4 inclusive of overlapping) was investigated, and the number of the count was used as the number of spontaneous alternation behavior. The percentage of spontaneous alternation behavior was calculated by dividing the number of spontaneous alternation behavior by a number obtained by subtracting 2 from the total number of entries, and multiplying a resultant number by 100. The percentage of spontaneous alternation behavior was used as an indicator. A higher value of the indicator suggested better maintenance of short-term memory. The measured values were expressed in the form of mean±standard error for each group. A significant difference between the control group and the scopolamine control group was calculated using Student's t-test. A significant difference between the scopolamine control group and FP-administered group was calculated using Student's t-test. Results are shown in FIG. 1 . It was suggested that Phe-Pro had a prophylactic activity against amnesia when administered at a dose of 5000 nmol/kg weight (1300 μg/kg). REFERENCES [0000] 1. Japanese Patent No. 3898389 2. Science, 217, 408-417 (1982) 3. Journal of Dairy Science, 81, 3131-3138 (1998)

The present invention provides a composition which may be ingested orally in a small dose for the purpose of improving brain function, and a method for improving brain function. The present invention is a composition for improving brain function, comprising, as an active ingredient, Phe-Pro.

FIELD OF THE INVENTION The invention relates to a damper for pressure measuring systems, for monitoring the pressure in blood pressure measurements comprising a flow passage and a compartment in fluid communication with said passage. For the continuous monitoring of arterial blood pressure, a pressure measuring system is often used which consists of a catheter introduced into a peripheral artery, a transmission line filled with a liquid, and a pressure sensor which converts the pressure at the end of the transmission line into a proportional electrical signal. This signal is then indicated on a screen or evaluated in some other manner. The transmission of dynamically varying pressures in closed liquid circuits creates the problem of reflections occurring from the maladaption of the pressure sensor to the liquid column; these reflections distort the measurement. For example, a pressure wave propagated from the patient to the pressure sensor is not fully absorbed by the pressure sensor but instead partly reflected by the sensor and return at reduced amplitude towards the patient. At the patient, the reflection will again be reflected back towards the sensor due to maladaptation. These multireflected pressure waves give rise to heterodyne waves whose resonant frequency may lie near a lower order harmonic of the first harmonic oscillation or the first harmonic. This may entail significant distortion of the measurement signal which cannot be removed from the evaluation. BACKGROUND OF THE INVENTION It is known (U.S. Pat. Nos. 4,431,009 and 4,335,729) that the parasitic oscillations can be attenuated by providing dampers in the vicinity of the pressure sensor in parallel with the transmission line. The dampers absorb part of the high frequency components of the pressure signal thereby moderating the amplitude of the reflected oscillations. The damper, according to U.S. Pat. No. 4,431,009, is embodied in an adjustable needle valve which represents a flow resistance that can be varied. The damper is arranged as a separate aggregate between the pressure measuring transformer and a three-way valve. This valve links the transmission line between the patient and the pressure sensor to an infusion means because in the majority of cases when blood pressure is continuously measured the transmission line is rinsed with an infusion solution. Finally, a check valve is also located in the transmission line so it can cut off the pressure sensor from the measuring system. This is required to adjust the pressure sensor to atmospheric pressure. The damper, according to U.S. Pat. No. 4,335,729is likewise designed as a needle valve and is connected to a branch-off from the transmission line. It includes a sealed compartment totally surrounded by rigid walls and containing an air cushion to dampen the oscillations. The flow cross section of the connection between the transmission line and the compartment is regulated by the adjustable needle valve. These dampers serve their purpose, however they are rather expensive for disposable items. Moreover, the additional adjustable component makes both measuring systems complex because they need to be continually adjusted. Finally, their structural design require the dampers to be mounted only at a certain distance from the pressure transducer so that their effect is not optimal. German patent DE 24 05 584 responds to the problem of reflections in a system for the pulse-wise ejection of droplets by suppressing the reflected pressure wave with acoustic impedance matching through an elastic conduit. German patent DE 29 41 118 shown a liquid spring damper comprising of two pot-like compartments which are supported "floatingly" with respect to each other by a shear spring. The two compartments communicate through a throttle. An elastic bellow is arranged inside the inner compartment and, as it is pressurized by adjustable gas pressure, it blocks the throttle at an appropriate gas pressure. The throttle does not open until the pressure n the main compartment exceeds that in the bellows. In this manner, a damper is provided which has a nonlinear characteristic and is adjustable by the pressure inside the bellows. SUMMARY OF THE INVENTION It is the object of the invention to improve the damper of the kind mentioned above so that it will have a more compact structure. The present had the damper integrated in a valve insert or body of the valve. The flow passage through the valve insert communicates through a capillary bore with a compartment formed in the valve insert and closed off by a rubber-elastic diaphragm. The diaphragm is supported so that it can be deformed primarily only in the direction that enlarges the compartment. There is another compartment on the other side of the diaphragm remote from the first compartment. This second compartment is connected to the atmosphere through a nozzle or port thereby communicating with ambient pressure. The diameter of the second compartment is bigger than the first so that the diaphragm can be deformed in the desired direction only. According to another variant of the invention, the movability of the diaphragm is limited, or even prevented altogether, by introducing a plunger into the second compartment. When it is in its one limited position, the plunger comes into contact with the diaphragm on its face end, and thereby blocks diaphragm movements. When the plunger is in any intermediate position, the maximum amplitude of deflection of the diaphragm will be limited and the volume of the second compartment will be varied. The damper is preferably integrated in the valve insert of a three-way valve. However, it may also e integrated in other types of valves, such as a simple shutoff valve according to a modification of the invention. BRIEF DESCRIPTION OF THE DRAWING The invention will be described further, by way of example, with reference to the accompanying drawings, in which: FIG. 1 is a cross sectional view of the damper in the valve insert of a three-way valve according to a first embodiment of the invention; FIG. 2 is a cross sectional view of a valve insert with damper according to a second embodiment of the invention; FIG. 3 is a side elevational view of a three-way valve including an integrated damper; and FIG. 4 is a top plan view of the valve shown in FIG. 3. DESCRIPTION OF THE PREFERRED EMBODIMENTS The three-way valve shown in FIG. 1 comprises a casing 1 which has three connecting ends 2, 3, 4 (cf. FIGS. 3 and 4) and in which a valve insert 5 (plug) is received. Depending on the rotary position of the valve insert passages 6 and to establish the valve insert flow connection between the various connecting ends 2, 3, and 4. In this respect, the valve is a conventional three-way valve. A damper is integrated in the vale insert 5. To achieve this, passages 6 and 7 in valve insert 5 are in fluid communication through a capillary bore 8 with a first compartment 9. The first compartment is integrated in the valve insert and in the embodiment shown is of cylindrical shape. The face end of the first compartment 9 remote from the capillary bore 8 is closed by a rubber-elastic diaphragm 10. The rim of the diaphragm 10 is retained in an annular groove 11 presented in a widening handle 15 of the valve insert. The diameter of the diaphragm 10 is distinctly greater than the diameter of the cylindrical first compartment 9 so that considerable portions of the diaphragm edge lie on the face end of the wall which defines the first compartment 9. In this manner, the diaphragm 10 can be deform to a greater extend in the direction of enlarging the first compartment 9 than in the opposite direction. The diaphragm 10 is retained by a cover 12 which is U-shaped in cross section and inserted in a recess formed in the handle 15. The shape of cover 12 together with the diaphragm 10 forms a second compartment 13. The diameter of the second compartment 13 is greater than that of the first compartment 9. The cover 12 has a nozzle-like port 14 through which ambient or atmospheric pressure is admitted to the second compartment 13. The dimension of the port 14 is chosen so small that it presents flow resistance to the air which is exchanged between the compartment 13 and the surroundings upon deflection of the diaphragm. In the embodiment illustrated in FIG. 2, the damper is adapted to be switched by a plunger 16. The plunger 16 is placed in the cover 12 and can be displaced in the axial direction. When the plunger is in one limited position it will contact the diaphragm, thereby preventing the diaphragm from oscillating. The diameter of the plunger corresponds approximately to the diameter of the first compartment 9, so that when it is in the limit position the face end of the plunger fully covers that area of the diaphragm 10 which closes the first compartment 9. In the embodiment shown, this plunger is threaded into the cover 12 by means of a thread 19 of relatively great pitch. A lever 17 is provided for actuation of the plunger 16. As an alternative, a vertical-horizontal lever an eccentric may be provided to selectively prevent deflections of the diaphragm. As the thread between the plunger 16 and the cover 12 is not absolutely tight, the function served by the port 14 in the embodiment according to FIG. 1 is fulfilled at the same time. FIGS. 3 and 4 are presentations of a three-way valve with an integrated damper. The valve with its damper may be secured by way of flanges directly to the measuring transformer (not shown) thereby offering a good damping characteristic throughout the measuring circuit. The collar 18 shown in FIGS. 1 and 2 at the valve insert serves to arrest the valve insert in the casing against any movement in axial direction.

The damper for pressure measuring systems is integrated in the body (5) or insert of a valve. Flow passages (6, 7) communicate with a compartment (9) which is sealed by a rubber-elastic diaphragm (10). The side of the diaphragm remote from said compartment (9) defines a second compartment (13) which is connected to atmosphere through a port (14) designed to provide flow resistance.

CROSS-REFERENCE TO RELATED APPLICATIONS None. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable. BACKGROUND OF THE INVENTION 1. Field of the Invention Embodiments of the invention are directed to preferentially delivering therapeutic gas to a patient. More particularly, the embodiments are directed to delivering therapeutic gas to one, a combination, or all of a patient's left naris, right naris and mouth selectively. 2. Background of the Invention Patients with respiratory ailments may be required to breathe a therapeutic gas, such as oxygen. The therapeutic gas may be delivered to the patient from a therapeutic gas source by way of a nasal cannula. Delivery of therapeutic gas to a patient may be continuous, or in a conserve mode. In continuous delivery, the therapeutic gas may be supplied at a constant flow throughout the patient's breathing cycle. A significant portion of the therapeutic gas provided in continuous delivery is wasted, i.e. the therapeutic gas delivered during exhalation of the patient is lost to atmosphere. In order to overcome the wastefulness of continuous delivery, related art devices may operate in conserve mode using a conserver system. A conserver may be a device which senses a patient's inspiration, and delivers a bolus of therapeutic gas only during inspiration. By delivering therapeutic gas only during inspiration, the amount of therapeutic gas lost to atmosphere may be reduced. Conserver systems of the related art may sense a patient's inspiration at one naris and delivery the bolus of therapeutic gas to the other naris, such as through a bifurcated nasal cannula. Alternatively, conserver devices of the related art may sense a patient's inspiration at the nares generally, and delivery a bolus of therapeutic gas to the nares generally, such as through a non-bifurcated (single lumen) nasal cannula. Sensing at one naris and delivering to a second naris may not work properly in all situations. If the patient has a blocked naris, e.g. because of congestion or some physical abnormality, either the sensing may not operate properly or the delivery of therapeutic gas may be to the blocked naris. Sensing and/or delivery may also fail to operate properly if the nasal cannula becomes dislodged, such as during sleep. Even if a nasal cannula stays properly on the patient and neither naris is blocked, delivering the patient's entire prescription of therapeutic gas through a single naris may cause nasal irritation. When sensing inspiration by monitoring both nares simultaneously, congestion and/or abnormalities in the nares may cause the system to not sense properly. Moreover, when delivering therapeutic gas to the nares generally, such as through a single lumen cannula, congestion and/or physical abnormalities of the nares may affect the volume inhaled in each naris, wasting therapeutic gas in some cases and not providing sufficient therapeutic gas in other cases. SUMMARY OF SOME OF THE PREFERRED EMBODIMENTS The problems noted above may be solved in large part by a method and system of individually sensing airflow of the breathing orifices of a patient, and preferentially delivering therapeutic gas to those breathing orifices. One exemplary embodiment may be a method comprising sensing airflow of a first and second breathing orifice of a patient, delivering therapeutic gas to the first breathing orifice in proportion to the airflow of the first breathing orifice, and delivering therapeutic gas to the second breathing orifice in proportion to the airflow of the second breathing orifice. The disclosed devices and methods comprise a combination of features and advantages which enable it to overcome the deficiencies of the prior art devices. The various characteristics described above, as well as other features, will be readily apparent to those skilled in the art upon reading the following detailed description, and by referring to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS For a detailed description of the preferred embodiments of the invention, reference will now be made to the accompanying drawings in which: FIG. 1 illustrates a preferential delivery system in accordance with embodiments of the invention; FIG. 2A illustrates, in shorthand notation, the system of FIG. 1 ; FIG. 2B illustrates an alternative embodiment of the system of FIG. 1 ; FIG. 2C illustrates yet another alternative embodiment of the system of FIG. 1 ; FIG. 3 illustrates a preferential delivery system in accordance with alternative embodiments of the invention; FIG. 4A illustrates, in shorthand notation, the system of FIG. 3 ; FIG. 4B illustrates an alternative embodiment of the system of FIG. 3 ; FIG. 4C illustrates yet another alternative embodiment of the system of FIG. 3 ; and FIG. 5 illustrates an alternative embodiment of the system of FIG. 3 using fewer three-port valves. NOTATION AND NOMENCLATURE Certain terms are used throughout the following description and claims to refer to particular system components. This document does not intend to distinguish between components that differ in name but not function. In the following discussion and in the claims, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to . . . ”. Also, the term “couple” or “couples” is intended to mean either an indirect or direct electrical or mechanical connection. Thus, if a first device couples to a second device, that connection may be through a direct connection, or through an indirect connection via other devices and connections. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 illustrates a preferential delivery system 100 in accordance with at least some embodiments of the invention. The preferential delivery system 100 may be coupled to a therapeutic gas source 10 by way of a gas port 11 . The therapeutic gas source 10 may be any suitable source of therapeutic gas, such as a portable cylinder, an oxygen concentration system or a permanent supply system as in a hospital. The selective delivery system also couples to a patient (not shown) by any of a variety of devices and systems by way of a variety of ports, such as narial ports 23 , 25 and an oral port 27 . For example, the preferential delivery system 100 may couple to a patient's nares by way of a nasal cannula. In accordance with embodiments of the invention, the preferential delivery system 100 monitors patient breathing and selectively delivers therapeutic gas to a left naris (LN), right naris (RN) and/or to the mouth (M) of the patient. In accordance with at least some embodiments, the preferential delivery system 100 comprises both electrical components and mechanical components. In order to differentiate between electrical connections and mechanical connections, FIG. 1 (and the remaining figures) illustrate electrical connections between components with dashed lines, and fluid connections, e.g. tubing connections between devices, with solid lines. The preferential delivery system 100 in accordance with at least some embodiments of the invention comprises a processor 12 . The processor 12 may be a microcontroller, and therefore the microcontroller may be integral with read-only memory (ROM) 14 , random access memory (RAM) 16 , a digital-to-analog converter (D/A) 18 , and an analog-to-digital converter (A/D) 20 . The processor 12 may further comprise communication logic 17 , which allows the system 100 to communicate with external devices, e.g., to transfer stored data about a patient's breathing patterns. Although a microcontroller may be preferred because of the integrated components, in alternative embodiments the processor 12 may be implemented by a stand-alone central processing unit in combination with individual RAM, ROM, communication D/A and A/D devices. The ROM 14 may store instructions executable by the processor 12 . In particular, the ROM 14 may comprise a software program that implements the various embodiments of the invention discussed herein. The RAM 16 may be the working memory for the processor 12 , where data may be temporarily stored and from which instructions may be executed. Processor 12 may couple to other devices within the preferential delivery system by way of A/D converter 20 and D/A converter 18 . Preferential delivery system 100 also comprises three-port valve 22 , three-port valve 24 , and three-port valve 26 . In accordance with embodiments of the invention, each of these three-port valves may be a five-volt solenoid operated valve that selectively fluidly couples one of two ports to a common port (labeled as C in the drawings). Three-port valves 22 , 24 and 26 may be Humprey Mini-Mizers having part No. D3061, such as may be available from the John Henry Foster Co., or equivalents. By selectively applying voltage on a digital output signal line coupled to the three-port valve 22 , the processor 12 may be able to: couple gas from the gas source 10 to the common port and therefore to the exemplary left naris; and couple the pressure sensor 28 to the common port and therefore the exemplary left naris. Likewise, the three-port valve 24 , under command of the processor 12 , may: couple gas from the gas source 10 to the narial port 23 and therefore the exemplary right naris; and couple the pressure sensor 30 to the narial port 23 and therefore the exemplary right naris. Further still, three-port valve 26 under command of the processor 12 , may: couple gas from the gas source 10 to the narial port 25 and therefore the patient's mouth; and couple the pressure sensor 32 to the narial port 25 and therefore the mouth. When the pressure sensors 28 , 30 and 32 are coupled to the respective ports, the processor 12 may read (through corresponding A/D converter 20 input signal lines) pressures indicative of airflow by the patient through the respective breathing orifice. Thus, the processor 12 may be able to determine when the patient is inhaling, and how much of the air drawn by the patient flows through each of the monitored breathing orifices. Consider a situation where the preferential delivery system 100 couples to the nares of the patient by way of a bifurcated nasal cannula. As the patient inhales, outlet ports in the nasal cannula proximate to the openings of each naris experience a drop in pressure. The drop in pressure may be sensed through the nasal cannula and associated hosing by each of the pressure sensors 28 and 30 . Likewise, a sensing and delivery tube may be placed proximate to the patient's mouth, and thus pressure sensor 32 may detect an oral inspiration by the patient. In accordance with embodiments of the invention, the preferential delivery system 100 senses whether a patient has airflow through a monitored breathing orifice, and delivers therapeutic gas to the location or locations where the therapeutic gas may be inhaled by the patient. Still considering the situation where the patient couples to the preferential delivery system 100 by way of a bifurcated nasal cannula and a separate sensing and delivery tube for the mouth, if there is no obstruction to inhalation in either of the nares or the mouth, therapeutic gas may be provided to any one or a combination of the nares and the mouth. Here, the preferential delivery system 100 may beneficially alternate the delivery site periodically so as to reduce discomfort associated with the therapeutic gas. Should the nasal cannula become partially dislodged, therapeutic gas may be provided only to the naris where the outlet port of the nasal cannula is still in operational relationship to the naris. Should the patient's nares become congested or blocked, therapeutic gas may be provided to the naris that is open. The embodiments of the invention described above may work equally well in systems delivering a continuous flow of therapeutic gas, as well as systems operating in a conserve mode. In the continuous mode of operation, each of the three-port valves 22 , 24 and 26 may couple therapeutic gas to their respective breathing orifice for extended periods of time, e.g. several respiratory cycles. Periodically, therapeutic gas delivery may cease and the preferential delivery system 100 may monitor the breathing pattern of the patient. That is, one or more of the three-port valves 22 , 24 and 26 may change valve position, thus coupling pressure sensors to their respective breathing orifices and stopping therapeutic gas flow. If a monitored breath or breaths show that none of the possible breathing orifices are blocked, then the system 100 may simply switch back to the continuous mode of operation. If the preferential delivery system cannot detect an inhalation for any one of the breathing orifices, continuous flow mode may be resumed without providing therapeutic gas to the breathing orifice experiencing a problem. In alternative embodiments, the preferential delivery system 100 may operate in a conserve mode, delivering a bolus of gas during each inhalation of the patient. Consider for purposes of explanation the left naris illustrated in FIG. 1 , as well as its associated three-port valve 22 and pressure sensor 28 . Prior to an inspiration, the three-port valve 22 may couple the pressure sensor to the common port of three-port valve 22 and therefore the left naris. As the patient starts an inhalation, as sensed by the pressure sensor 28 and read by processor 12 , the three-port valve 22 changes valve position (as commanded by processors 12 ) and couples the therapeutic gas source 10 to the common port (and effectively blocking the pressure sensor from the common port). For a period of time, e.g. 100 mili-seconds, therapeutic gas may flow to the exemplary left naris. When the desired bolus volume has been delivered, possibly as a function of flow rate of the therapeutic gas and time, the processor 12 may command the three-port valve 22 to its original state, again fluidly coupling the pressure sensor 28 to the left naris. During exhalation, again sensed by pressure sensor 28 , the three-port valve 22 remains in the valve position coupling the pressure sensor to the common port, and therefore no therapeutic gas is delivered. This exemplary process is equally applicable to three-port valve 24 and pressure sensor 30 in operational relationship to the right naris, as well as three-port valve 26 and pressure sensor 32 in operational relationship to the patient's mouth. Thus, in conserve mode, the preferential delivery system 100 may detect whether the nares and/or mouth are open to therapeutic gas flow with each inspiration. In the event an inspiration on any particular delivery path is not detected, indicating a blockage or other gas delivery problem (such as a dislodged cannula), the preferential delivery system 100 may refrain from providing therapeutic gas to that breathing orifice. FIG. 2A illustrates the preferential delivery system 100 of FIG. 1 in a shorthand notation, showing only pressure sensors 28 , 30 and 32 coupled to the respective breathing orifices. FIG. 2B illustrates alternative embodiments of the invention monitoring and delivering therapeutic gas only to the nares of a patient. In the embodiments of FIG. 2B , if both the left naris and right naris are open to flow the preferential delivery system 100 may deliver therapeutic gas to either naris, to both nares, or in an alternating fashion. In the event that either the left or right naris become clogged or blocked, or if the sensing and delivery tubing (such as a nasal cannula) become dislodged, the preferential delivery system may provide therapeutic gas to the naris where airflow is sensed. FIG. 2C illustrates alternative embodiments of the invention where two pressure sensors are used, but in this case only one pressure sensor is associated with the nares, and the second pressure sensor is associated with the mouth. In the embodiments of FIG. 2C , a patient may utilize a single lumen cannula and a second sensing and delivery tube associated with the mouth. The preferential delivery system 100 may thus selectively provide therapeutic gas to the nares and/or to the mouth. In the event that either of the nares as a group or the mouth become blocked or otherwise unavailable for inspiration, the preferential delivery system 100 preferably provides therapeutic gas to the breathing orifice through which inhalation takes place. FIG. 3 illustrates a preferential delivery system 102 constructed in accordance with alternative embodiments of the invention. Like the system of FIG. 1 , the preferential delivery system 102 comprises a processor 12 , possibly in the form of a microcontroller, comprising ROM 14 , RAM 16 , a D/A converter 18 and an A/D converter 20 . Rather than pressure sensors, the preferential delivery system 102 may use flow sensors 40 , 42 and 44 . Thus, the preferential delivery system 102 may sense a portion of the flow associated with each breathing orifice. Consider for purposes of explanation the flow sensor 40 and three-port valves 46 , 48 coupled to the left naris. Three-port valve 46 , under command of the processor 12 , may: couple the gas source 10 to the common port and therefore the exemplary left naris; and couple the flow sensor 40 to the common port and therefore the exemplary left naris. Thus, during a period of time when the preferential delivery system 102 provides therapeutic gas to the left naris (whether continuous or in a bolus form), the three-port valve 46 provides the therapeutic gas to the left naris and blocks the flow sensor. In a second valve position, the three-port valve 46 fluidly couples the flow sensor to the common port and therefore the exemplary left naris. However, and in accordance with embodiments of the invention, the flow sensor 40 may not be operational until gas can flow through the sensor. Three-port valve 48 , in a first valve position, couples the flow sensor 40 to an atmospheric vent (marked ATM in the drawing), thus allow gas to flow through the flow sensor for measurement purposes. The three-port valve 48 , in a second valve position, couples to a blocked port 49 . Consider for purposes of explanation a preferential delivery system 102 operating in a conserve mode, where a bolus of gas is provided to one or more breathing orifices during inspiration. After a bolus has been delivered, the three-port valve 46 (and possibly the three-port valves 50 and 54 ) may change valve positions, thus fluidly coupling the flow sensor 40 to the common port and the exemplary left naris. If the flow sensor 40 outlet is not blocked, a portion of the therapeutic gas may reverse flow through the flow sensor 40 and out the atmospheric vent. Three-port valve 48 (as well as corresponding three-port valves 52 and 56 ) may be used to temporarily block reverse flow and loss of therapeutic gas, i.e. the valves may remain in a position that blocks flow for about 300 milliseconds after therapeutic gas delivery has stopped by a change of valve position by upstream three-port valves 46 , 50 and 54 . After the expiration of the period of time of possible reverse flow has ended, one or more of the three-port valves 48 , 52 and 56 may change valve positions, thus allowing the flow sensors to sense airflow. The description with respect to the three-port valves 46 , 48 and flow sensor 40 for the left naris is equally applicable for the corresponding structures for the right naris and mouth. FIG. 4A illustrates the preferential delivery system 102 of FIG. 3 in a shorthand notation, showing only flow sensors 40 , 42 and 44 coupled to their respective breathing orifice. FIG. 4B illustrates alternative embodiments of the invention where only a patient's nares are used for sensing and delivery. In the embodiments of FIG. 4B , if both the left naris and the right naris are open to flow, the preferential delivery system 102 may deliver therapeutic gas to either naris, to both nares, or in an alternating fashion. In the event that either the left or right naris become clogged or blocked, or if the sensing and delivery tubing become dislodged, the preferential delivery system may provide therapeutic gas only to the unblocked naris. FIG. 4C illustrates further alternative embodiments where two flow sensors are used, but in this case only one flow sensor is associated with the nares, and the second flow sensor associated with the mouth. In the embodiments of FIG. 4C , a patient may utilize a single lumen cannula, and a second sensing and delivery tube associated with the mouth. The preferential delivery system 100 may thus selectively provide therapeutic gas to the nares and/or the mouth. In the event that either of the nares as a group or the mouth become blocked or otherwise unavailable for inspiration, the preferential delivery system 102 preferably provides therapeutic gas to the open breathing orifice. FIG. 5 illustrates alternative embodiments of the invention utilizing flow sensors, but reducing the number of three-port valves used. The electrical components have been omitted from FIG. 5 for purposes of clarity. In particular, FIG. 5 illustrates that the three three-port valves 48 , 52 and 56 of FIG. 3 may be replaced by a single three-port valve 58 . Blocking reverse flow through the flow sensors in the embodiments of FIG. 5 may be accomplished by single three-port valve 58 . Relatedly, opening the second port of each of the flow sensors to the atmosphere vent so that flow may be detected may likewise be accomplished with a single three-port valve 58 . The embodiments discussed to this point control therapeutic gas flow in a boolean fashion. That is, therapeutic gas is either delivered to a breathing orifice, or the preferential delivery systems 100 , 102 refrain from delivering therapeutic gas to a breathing orifice. However, alternative embodiments of the invention, which may be implemented using any of the exemplary embodiments described above, may control flow to each breathing orifice in proportion (either direct or inverse) to the amount of airflow drawn by that breathing orifice. Consider, for purposes of explanation, the pressure and flow sensor embodiments illustrated by FIGS. 2B and 4B . For a variety of reasons, such as congestion, physical abnormalities, periodic swelling of the nasal tissue, and the like, the amount of air flow drawn by a patient during inhalation through the nares may not be equal. By detecting a pressure and/or detecting a portion of the air flow through each naris, the preferential delivery systems 100 , 102 may quantify the relationship between the air flow as between the nares. For example, the left naris of an exemplary patient may carry 20% of the airflow, and the right naris of a patient may carry the remaining 80% of the air flow. In the embodiments discussed above, therapeutic gas may only be delivered to the right naris, carrying the bulk of the airflow. In the alternative embodiments, the selective delivery systems 100 , 102 may proportion delivery of therapeutic gas. In the example of an 20–80 split between the left naris and the right naris respectively, the preferential delivery system 100 , 102 may correspondingly proportion therapeutic gas flow 20% to the left naris and 80% to the right naris, or vice-versa. As the patient's left naris becomes less congested (or the patient changes head position that affects air flow or swelling, the preferential delivery system may likewise change the proportion of therapeutic gas flow. Referring again to FIG. 3 , proportioning therapeutic gas flow may be accomplished by pulse width modulating each of the three-port valves 46 , 50 and 54 by the processor 12 . In an exemplary situation where a patient's left naris carries only 20% of the total airflow and control is a direct proportion, the electrical signal from the processor 12 to the three-port valve 46 may be pulse width modulating at a duty cycle where only 20% of the therapeutic gas is delivered to the left naris. Although the discussion with respect to the alternative embodiments where therapeutic gas may be proportioned between breathing orifices focused only on proportioning the nares, the proportioning may likewise be done between the nares in general and the mouth, or all three breathing orifices. In all of the embodiments, in the event an inhalation is not detected through any breathing orifice, an alarm may be sounded. Relatedly, if the preferential delivery systems sense an apnea event, an alarm may be sounded. Moreover, the patient's breathing patterns may be stored, such as in RAM 16 , and communicated to external devices through communication port 17 . The above discussion is meant to be illustrative of the principles and various embodiments of the present invention. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. For example, while the use of a cannula, at least with respect to coupling the preferential delivery system to the nares, has been discussed, this is only exemplary and any system and method by which the therapeutic gas is fluidly coupled from the preferential delivery system to the breathing orifices of the patient may be equivalently used. A single lumen cannula may be operable in some situations with respect to the nares. Likewise, a bifurcated nasal cannula may be used with respect to the nares. Alternatively, a cannula may be used where the sensing lines couple to the flow sensors are separate and distinct from the lines in which therapeutic gas is delivered proximate to the breathing orifices. Further, while the various embodiments described use electrical components as the control system, other pneumatic/mechanical systems may be equivalently used. It is intended that the following claims be interpreted to embrace all such variations and modifications.

Methods and related systems for individually sensing airflow in the breathing orifices of a patient, and preferentially delivering therapeutic gas to those breathing orifices based on the amount of airflow sensed.

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation-in-part of application Ser. No. 103,148, filed Dec. 13, 1979, now abandoned. BACKGROUND OF THE INVENTION This invention relates to novel semisynthetic antifungal compounds which are prepared by the acylation of the cyclic peptide nucleus produced by the enzymatic deacylation of antibiotic S31794/F-1. Antibiotic S31794/F-1 is an antifungal cyclic peptide having the formula: ##STR9## wherein R is the myristoyl group. Throughout this application, the cyclic peptide formulas, such as formula I, assume that the amino acids represented are in the L-configuration. Antibiotic S31794/F-1, which is disclosed in German Offenlegungschrift 2,628,965 and U.S. Pat. No. 4,173,629, is produced by Acrophialophora limonispora nov. spec. Dreyfuss et Muller NRRL 8095. S31794/F-1 has the following characteristics: m.p. 178°-180° C. (dec.) (amorphous) or 181°-183° C. (dec.) (crystalline); [α] D 20 -24° (c 0.5, CH 3 OH) or +37° (c 0.5, pyridine) (crystalline); UV absorption maxima in methanol at 194 nm (E 1cm 1% =807), 225 nm (shoulder) E 1cm 1% =132), 276 nm (E 1cm 1% =12.8), 284 nm (shoulder) E 1cm 1% =10.5); 13 C-NMR spectrum in deuteromethanol (190 mg in 1.5 ml deuteromethanol, tetramethylsilane as internal standard) with the following characteristics (crystalline): ______________________________________PPM PPM PPM______________________________________176.2 75.5 51.2175.0 74.0 39.7173.7 71.0 38.8172.6 70.5 36.6172.0 69.7 34.8171.8 68.0 32.8171.7 62.2 30.6168.6 58.3 26.7157.7 57.0 23.5132.5 56.2 19.7129.0 55.4 14.3115.9 52.9 11.1 76.6______________________________________ an approximate elemental analysis (after drying crystalline material for two hours in a high vacuum at 100° C.) as follows: 55.5-56.5 percent carbon, 7.5-7.7 percent hydrogen, 10.5-10.8 percent nitrogen and 25.5-26.0 percent oxygen; is readily soluble in methanol, ethanol, pyridine, dimethyl sulfoxide and poorly soluble in water, chloroform, ethyl acetate, diethyl ether, benzene and hexane; and has antifungal activity, especially against Candida albicans. Antibiotic S31794/F-1 is prepared by submerged aerobic cultivation of Acrophialophora limonispora NRRL 8095 as described in Examples 4 and 5. This microorganism is a part of the permanent culture collection of the Northern Regional Research Center, U.S. Department of Agriculture, Agricultural Research Culture Collection, North Central Region, Peoria, Ill. 61604, from which it is available to the public under the designated NRRL number. Antibiotic S31794/F-1 has antifungal activity, particularly against Candida strains such as Candida albicans. Thus, production and isolation of the antibiotic can be monitored by bioautography using a Candida species such as Candida albicans. In the antibiotic S31794/F-1 molecule (Formula I), the myristoyl side chain (R) is attached at the cyclic peptide nucleus at the α-amino group of the dihydroxyornithine residue. Surprisingly, it has been found that the myristoyl side chain can be cleaved from the nucleus by an enzyme without affecting the chemical intregity of the nucleus. The enzyme employed to effect the deacylation reaction is produced by a microorganism of the family Actinoplanaceae, preferably the microorganism Actinoplanes utahensis NRRL 12052, or a variant thereof. To accomplish deacylation, antibiotic S31794/F-1 is added to a culture of the microorganism and the culture is allowed to incubate with the substrate until the deacylation is substantially complete. The cyclic nucleus thereby obtained is separated from the fermentation broth by methods known in the art. Unlike antibiotic S31794/F-1, the cyclic nucleus (lacking the linoleoyl side chain) is substantially devoid of antifungal activity. The cyclic nucleus afforded by the aforedescribed enzymatic deacylation of antibiotic S31794/F-1 is depicted in Formula II. ##STR10## S31794/F-1 nucleus has an empirical formula of C 35 H 52 N 8 O 16 and a molecular weight of 840.87. Removal of the side chain group affords a free primary α-amino group in the dihydroxyornithine residue of the cyclic peptide. For convenience, the compound having the structure given in Formula II will be referred to herein as "S31794/F-1 nucleus." As will be apparent to those skilled in the art, S31794/F-1 nucleus can be obtained either in the form of the free amine or of the acid addition salt. Although any suitable acid addition salt may be employed, those which are non-toxic and pharmaceutically acceptable are preferred. The method of preparing S31794/F-1 nucleus from antibiotic S31794/F-1 by means of fermentation using Actinoplanes utahensis NRRL 12052 is described in the co-pending application of Bernard J. Abbott and David S. Fukuda, entitled "S 31794/F-1 NUCLEUS", Ser. No. 103,313 which was filed Dec. 13, 1979. A continuation-in-part application of this application, with corresponding Ser. No. 181,036, is being filed herewith this even date, the full disclosure of which is incorporated herein by reference. Example 3 herein, illustrates the preparation of S31794/F-1 nucleus by fermentation using antibiotic S31974/F-1 as the substrate and Actinoplanes utahensis NRRL 12052 as the microorganism. The enzyme produced by Actinoplanes utahensis NRRL 12052 may be the same enzyme which has been used to deacylate penicillins (see Walter J. Kleinschmidt, Walter E. Wright, Frederick W. Kavanagh, and William M. Stark, U.S. Pat. No. 3,150,059, issued Sept. 22, 1964). Cultures of representative species of Actinoplanaceae are available to the public from the Northern Regional Research Laboratory under the following accession numbers: ______________________________________Actinoplanes utahensis NRRL 12052Actinoplanes missouriensis NRRL 12053Actinoplanes sp. NRRL 8122Actinoplanes sp. NRRL 12065Streptosporangium roseumvar. hollandesis NRRL 12064______________________________________ The effectiveness of any given strain of microorganism within the family Actinoplanaceae for carrying out the deacylation of this invention is determined by the following procedure. A suitable growth medium is inoculated with the microorganism. The culture is incubated at about 28° C. for two or three days on a rotary shaker. One of the substrate antibiotics is then added to the culture. The pH of the fermentation medium is maintained at about pH 6.5. The culture is monitored for activity using a Candida albicans assay. Loss of antibiotic activity is an indication that the microorganism produces the requisite enzyme for deacylation. This must be verified, however, using one of the following methods: (1) analysis by HPLC for presence of the intact nucleus; or (2) re-acylation with an appropriate side chain (e.g. linoleoyl, stearoyl, or palmitoyl) to restore activity. SUMMARY OF THE INVENTION The invention sought to be patented comprehends novel compounds derived by acylating S31794/F-1 nucleus (Formula II). The compounds of the present invention have the chemical structure depicted in Formula III: ##STR11## wherein R 1 is an N-alkanoyl amino acyl group of the formula ##STR12## wherein: W is a divalent aminoacyl radical of the formula: ##STR13## wherein A is C 1 -C 10 alkylene or C 5 -C 6 cycloalkylene; ##STR14## wherein R 3 is hydroxymethyl, hydroxyethyl, mercaptomethyl, mercaptoethyl, methylthioethyl, 2-thienyl, 3-indolemethyl, benzyl, or substituted phenyl or substituted benzyl in which the benzene ring thereof is substituted with chloro, bromo, iodo, nitro, C 1 -C 3 alkyl, hydroxy, C 1 -C 3 alkylthio, carbamyl, or C 1 -C 3 alkylcarbamyl; ##STR15## wherein X is hydrogen, chloro, bromo, iodo, nitro, C 1 -C 3 alkyl, hydroxy, C 1 -C 3 alkoxy, mercapto, C 1 -C 3 alkylthio, carbamyl, or C 1 -C 3 alkylcarbamyl; ##STR16## wherein X 1 is chloro, bromo, or iodo; ##STR17## wherein B is a divalent radical of the formula: --(CH 2 ) n --, wherein n is an integer from 1 to 3; --CH═CH--; --CH═CH--CH 2 --; or ##STR18## and R 2 is C 1 -C 17 alkyl or C 2 -C 17 alkenyl. As employed herein the terms "alkylene", "alkyl", "alkoxy", "alkylthio", and "alkenyl" comprehend both straight and branched hydrocarbon chains. "Alkyl" means a univalent saturated hydrocarbon radical. "Alkenyl" means a univalent unsaturated hydrocarbon radical containing one, two, or three double bonds, which may be oriented in the cis or trans configuration. "Alkylene" means a divalent saturated hydrocarbon radical. "Cycloalkylene" means a divalent cyclic saturated hydrocarbon radical. Illustrative C 1 -C 10 alkylene radicals, which are preferred for purposes of this invention are: --CH 2 --; ##STR19## in which R 5 is C 1 -C 4 alkyl (i.e., methyl, ethyl, n-propyl, i-propyl, n-butyl, t-butyl, i-butyl, or l-methylpropyl); --(CH 2 ) m --in which m is an integer from 2 to 10; and CH 3 --(CH 2 ) q --CH--(CH 2 ) p --, in which p is an integer from 1 to 8 and q is an integer from 0 to 7, provided that n+m must be no greater than 8. Illustrative C 1 -C 17 alkyl groups which are preferred for the purposes of this invention are: (a) CH 3 --; (b) --(CH 2 ) n CH 3 wherein n is an integer from 1 to 16; and (c) ##STR20## wherein r and s are independently, an integer from 0 to 14 provided that r+s can be no greater than 14. Illustrative C 2 -C 17 alkenyl radicals, which are preferred for the purpose of this invention, are (a) --(CH 2 ) t --CH═CH--(CH 2 ) u --CH 3 wherein t and u are independently, an integer from 0 to 14 provided that t+u can be no greater than 14. (b) --(CH 2 ) v --CH═CH--(CH 2 ) y --CH═CH--(CH 2 ) z --CH 3 wherein v and z are independently, an integer from 0 to 11 and y is an integer from 1 to 12 provided that v+y+z can be no greater than 11. In particular, the following embodiments of the C 1 -C 17 alkyl groups are preferred: CH 3 -- CH 3 (CH 2 ) 5 -- CH 3 (CH 2 ) 6 -- CH 3 (CH 2 ) 8 -- CH 3 (CH 2 ) 10 -- CH 3 (CH 2 ) 12 -- CH 3 (CH 2 ) 14 -- CH 3 (CH 2 ) 16 -- In particular, the following embodiments of the C 2 -C 17 alkenyl groups are preferred: cis-CH 3 (CH 2 ) 5 CH═CH(CH 2 ) 7 -- trans-CH 3 (CH 2 ) 5 CH═CH(CH 2 ) 7 -- cis-CH 3 (CH 2 ) 10 CH═CH(CH 2 ) 4 -- trans-CH 3 (CH 2 ) 10 CH═CH(CH 2 ) 4 -- cis-CH 3 (CH 2 ) 7 CH═CH(CH 2 ) 7 -- trans-CH 3 (CH 2 ) 7 CH═CH(CH 2 ) 7 -- cis-CH 3 (CH 2 ) 5 CH═CH(CH 2 ) 9 -- trans-CH 3 (CH 2 ) 5 CH═CH(CH 2 ) 9 -- cis, cis-CH 3 (CH 2 ) 4 CH═CHCH 2 CH═CH(CH 2 ) 7 -- trans, trans-CH 3 (CH 2 ) 4 CH═CHCH 2 CH═CH(CH 2 ) 7 -- cis,cis,cis-CH 3 CH 2 CH═CHCH 2 CH═CHCH 2 CH═CH--(CH 2 ) 7 --. When "W" is a divalent radical of the formula ##STR21## it will be recognized by those skilled in the art that the ##STR22## function and the --NH-- function may be oriented on the benzene ring in the ortho, meta, or para configuration relative to each other. The substituent represented by X may be substituted at any available position of the benzene ring. Preferred embodiments are those in which X is hydrogen and the ##STR23## and --NH-- functions are oriented in the para configuration. The terms "substituted phenyl" and "substituted benzyl", as defined by R 3 in Formula III, contemplate substitution of a group at any of the available positions in the benzene ring--i.e. the substituent may be in the ortho, meta, or para configuration. The term "C 1 -C 3 alkyl" as defined by R 3 or X in Formula III includes the methyl, ethyl, n-propyl, or i-propyl groups. DETAILED DESCRIPTION OF THE INVENTION The compounds of Formula III inhibit the growth of pathogenic fungi, and are useful, therefore, for controlling the growth of fungi on environmental surfaces (as an antiseptic) or in treating infections caused by fungi. In particular, the compounds are active against Candida albicans and are, thus especially useful for treating candidosis. The activity of the compounds can be assessed in standard microbiological test procedures, such as in vitro in agar plate disc diffusion tests or in agar tube dilution tests, or in vivo in tests in mice infected in C. albicans. The compounds are also active against Trichophyton mentagrophytes (a dermatophytic organism), Saccharomyces pastorianus, and Neurospora crassa. The compounds of Formula III are prepared by acylating S31794/F-1 nucleus at the α-amino group of dihydroxyornithine with the appropriate N-alkanoyl aminoacyl or N-alkenoyl amino acyl side chain using methods conventional in the art for forming an amide bond. The acylation is accomplished, in general, by reacting the nucleus with an activated derivative of the acid (Formula IV) corresponding to the desired acyl side chain group. ##STR24## (W and R 2 have the meaning described herein supra). By the term "activated derivative" is meant a derivative which renders the carboxyl function of the acylating agent reactive to coupling with the primary amino group to form the amide bond which links the acyl side chain to the nucleus. Suitable activated derivatives, their methods of preparation, and their methods of use as acylating agents for a primary amine will be recognized by those skilled in the art. Preferred activated derivatives are: (a) an acid halide (e.g. acid choride), (b) an acid anhydride (e.g. an alkoxyformic acid anhydride or aryloxyformic acid anhydride) or (c) an activated ester (e.g. a 2,4,5-trichlorophenyl ester, a N-hydroxybenztriazole ester, or an N-hydroxysuccinimide ester). Other methods for activating the carboxyl function include reaction of the carboxylic acid with a carbonyldiimide (e.g. N,N-dicyclohexylcarbodiimide or N,N'-diisopropylcarbodiimide) to give a reactive intermediate which, because of instability, is not isolated, the reaction with the primary amine being carried out in situ. A preferred method for preparing the compounds of Formula III is by the active ester method. The use of the 2,4,5-trichlorophenyl ester of the desired N-alkanoylamino acid or N-alkenoylamio acid (Formula IV) as the acylating agent is most preferred. In this method, an excess amount of the active ester is reacted with the nucleus at room temperature in a nonreactive organic solvent such as dimethyl formamide (DMF). The reaction time is not critical, although a time of about 15 to about 18 hours is preferred. At the conclusion of the reaction, the solvent is removed, and the residue is purified such as by column chromatography using silica gel as the stationary phase and a mixture of ethyl acetate/methanol (3:2, v/v) as the solvent system. The 2,4,5-trichlorophenyl esters of the N-alkanoylamino acids or N-alkanoylamino acids can be prepared conveniently by treating the desired amino acid (Formula IV) with 2,4,5-trichlorophenol in the presence of a coupling agent, such as N,N'-dicyclohexylcarbodiimide. Other methods suitable for preparing amino acid esters will be apparent to those skilled in the art. The N-alkanoylamino acids or N-alkenoylamino acids are either known compounds or they can be made by acylating the appropriate amino acid with the appropriate alkanoyl or alkenoyl group using conventional methods, such as those described herein supra. A preferred way of preparing the N-alkanoylamino acids is by treating the appropriate amino acid with an alkanoic acid chloride in pyridine. The alkanoic acids, the activated derivatives thereof, and the amino acids employed in the preparation of the products of this invention are either known compounds or they can be made by known methods or by modification of known methods which will be apparent to those skilled in the art. If a particular amino acid contains an acylable functional group other than the amino group, it will be understood by those skilled in the art that such a group must be protected prior to reaction of the amino acid with the reagent employed to attach the alkanoyl or alkenoyl group. Suitable protecting groups can be any group known in the art to be useful for the protection of a side chain functional group in peptide synthesis. Such groups are well known, and the selection of a particular protecting group and its method of use will be readily known to one skilled in the art [see, for example, "Protective Groups In Organic Chemistry", M. McOmie, Editor, Plenum Press, N.Y., 1973]. It will be recognized that certain amino acids employed in the synthesis of the products of this invention may exist in optically active forms, and both the natural configuration (L-configuration) and unnatural configuration (D-configuration) may be employed as starting materials and will give products which are within the contemplation of this invention. When employed systemically, the dosage of the compounds of Formula III will vary according to the particular compound being employed, the severity and nature of the infection, and the physical condition of the subject being treated. Therapy should be initiated at low dosages, the dosage being increased until the desired antifungal effect is obtained. The compounds can be administered intravenously or intramuscularly by injection in the form of a sterile aqueous solution or suspension to which may be added, if desired, various conventional pharmaceutically acceptable preserving, buffering, solubilizing, or suspending agents. Other additives, such as saline or glucose may be added to make the solutions isotonic. The proportions and nature of such additives will be apparent to those skilled in the art. When employed to treated vaginal candida infections, the compounds of Formula III can be administered in combination with pharmaceutically acceptable conventional excipients suitable for intravaginal use. Formulations adapted for intravaginal administration will be known to those skilled in the art. One of the methods of making and using the compounds of the present invention is illustrated in the following examples: EXAMPLE 1 The following procedure, which give the preparation of the compound of Formula III wherein R 1 is N-(n-dodecanoyl)-p-aminobenzoyl, illustrates a method of preparation of the compounds of Formula III. A. Preparation of N-(n-dodecanoyl)-p-aminobenzoic acid n-Dodecanoyl chloride (8.74 g.; 40 mmoles) is added dropwise to a solution of p-aminobenzoic acid (40 mmoles) dissolved in pyridine (100 ml.). The mixture is stirred for 3 hours and poured into water (3 l.). The precipitate which forms is filtered and dried in vacuo to give N-(n-dodecanoyl)-p-aminobenzoic acid (11.01 g.). B. Preparation of the 2,4,5-trichlorophenyl ester of N-dodecanoyl-p-aminobenzoic acid N-(n-Dodecanoyl)-p-aminobenzoic acid (11.01 g.; 34.5 mmoles), 2,4,5-trichlorophenol (7.5 g.; 38 mmoles), and dicyclohexylcarbodiimide (6.94 g.; 34.5 mmoles) are dissolved in methylene chloride (250 ml). The mixture is stirred at room temperature for 3.5 hours and then filtered. The filtrate is evaporated in vacuo to give a residue which is crystallized from acetonitrile/water to afford the 2,4,5-trichlorophenyl ester of N-(n-dodecanoyl)-p-aminobenzoic acid (12.84 g.). C. Acylation of S31794/F-1 nucleus S317941F-1 nucleus (10.2 mmoles) and the 2,4,5-trichlorophenyl ester of N-(n-dodecanoyl)-p-aminobenzoic acid (10.2 mmoles) are dissolved in dimethylformamide (100 ml.). The solution is stirred at room temperature for 15 hours. Solvent is removed in vacuo to give a residue which is washed twice with diethylether. The washes are discarded. The washed residue is dissolved in methanol (50 ml.) and is purified by reversed phase HPLC by means of a "Prep LC/System 500" unit (Waters Associates, Inc., Milford, Mass.) using a Prep Pak-500/C18 column (Water Associates, Inc.) as the stationary phase. The column is eluted isocratically with H 2 O/CH 3 OH/CH 3 CN (25:65:10 v/v) at 500 psi. The fractions are analyzed by TLC using silica gel plates and H 2 O/CH 3 OH/CH 3 CN (25:65:10 v/v) as the solvent system. Fractions containing the desired products are combined and lyophilized to give the N-(n-dodecanoyl)-p-aminobenzoyl derivative of S31794/F-1 nucleus. EXAMPLE 2 The method described in Example 1, with minor changes, can be used to synthesize additional derivatives of the S31794/F-1 nucleus. The substitution of the appropriate acyl chloride and amino acid in Step A, the substitution of the appropriate N-alkanoyl amino acid, (plus the use of tetrahydrofuran as the solvent for N-alkanoyl monochloro-substituted aminobenzoic acids), in Step B, and the substitution of the appropriate 2,4,5 trichlorophenyl ester in Step C of Example 1 can yield the derivatives of the S31794/F-1 nucleus shown below: ______________________________________N-Alkanoylamino Acid Derivatives of S31794/F-1 Nucleus ##STR25## IIIR.sup.1______________________________________CH.sub.3 (CH.sub.2).sub.10 CONHCH(CH.sub.2 C.sub.6 H.sub.5)COCH.sub.3 (CH.sub.2).sub.10 CONH(CH.sub.2).sub.4CO(CH.sub.3 (CH.sub.2).sub.10 CONH(CH.sub.2).sub.10CO ##STR26## ##STR27## ##STR28## ##STR29## ##STR30## ##STR31## ##STR32## ##STR33## ##STR34## ##STR35## ##STR36##CH.sub.3 (CH.sub.2).sub.5 CONH(CH.sub.2).sub.10CO ##STR37## ##STR38## ##STR39## ##STR40## ##STR41## ##STR42## ##STR43## ##STR44## ##STR45## ##STR46## ##STR47## ##STR48## ##STR49## ##STR50## EXAMPLE 3 Preparation of S31794/F-1 Nucleus A. Fermentation of Actinoplanes utahensis NRRL 12052 A stock culture of Actinoplanes utahensis NRRL 12052 is prepared and maintained on an agar slant. The medium used to prepare the slant is selected from one of the following: ______________________________________MEDIUM A______________________________________Ingredient Amount______________________________________Baby oatmeal 60.0 gYeast 2.5 gK.sub.2 HPO.sub.4 1.0 gCzapek's mineral stock* 5.0 mlAgar 25.0 gDeionized water q.s. to 1 liter______________________________________ pH before autoclaving is about 5.9; adjust to pH 7.2 by addition of NaOH; after autoclaving, pH is about 6.7. *Czapek's mineral stock has the following composition: Ingredient AmountFeSO.sub.4 . 7H.sub.2 O (dissolved in2 ml conc HCl) 2 gKCl 100 gMgSO.sub.4 . 7H.sub.2 O 100 gDeionized water q.s. to 1 liter ______________________________________MEDIUM BIngredient Amount______________________________________Potato dextrin 5.0 gYeast extract 0.5 gEnzymatic hydrolysate of casein* 3.0 gBeef extract 0.5 gDextrose 12.5 gCorn starch 5.0 gMeat peptone 5.0 gBlackstrap molasses 2.5 gMgSO.sub.4 . 7H.sub.2 O 0.25 gCaCO.sub.3 1.0 gCzapek's mineral stock 2.0 mlAgar 20.0 gDeionized water q.s. to 1 liter______________________________________ The slant is inoculated with Actinoplanes utahensis NRRL 12052, and the inoculated slant is incubated at 30° C. for about 8 to 10 days. About 1/2 of the slant growth is used to inoculate 50 ml of a vegetative medium having the following composition: ______________________________________Ingredient Amount______________________________________Baby oatmeal 20.0 gSucrose 20.0 gYeast 2.5 gDistiller's Dried Grain* 5.0 gK.sub.2 HPO.sub.4 1.0 gCzapek's mineral stock 5.0 mlDeionized water q.s. to 1 liter______________________________________ adjust to pH 7.4 with NaOH; after autoclaving, pH is about 6.8. *National Distillers Products Co., 99 Park Ave., New York, N.Y. The inoculated vegetative medium is incubated in a 250-ml wide-mouth Erlenmeyer flask at 30° C. for about 72 hours on a shaker rotating through an arc two inches in diameter at 250 RPM. This incubated vegetative medium may be used directly to inoculate a second-stage vegetative medium. Alternatively and preferably, it can be stored for later use by maintaining the culture in the vapor phase of liquid nitrogen. The culture is prepared for such storage in multiple small vials as follows: In each vial is placed 2 ml of incubated vegetative medium and 2 ml of a glycerol-lactose solution [see W. A. Dailey and C. E. Higgens, "Preservation and Storage of Microorganisms in the Gas Phase of Liquid Nitrogen, Cryobiol 10, 364-367 (1973) for details]. The prepared suspensions are stored in the vapor phase of liquid nitrogen. A stored suspension (1 ml) thus prepared is used to inoculate 50 ml of a first-stage vegetative medium (having the composition earlier described). The inoculated first-stage vegetative medium is incubated as above-described. In order to provide a larger volume of inoculum, 10 ml of the incubated first-stage vegetative medium is used to inoculate 400 ml of a second-stage vegetative medium having the same composition as the first-stage vegetative medium. The second-stage medium is incubated in a two-liter wide-mouth Erlenmeyer flask at 30° C. for about 48 hours on a shaker rotating through an arc two inches in diameter at 250 RPM. Incubated second-stage vegetative medium (800 ml), prepared as above-described, is used to inoculate 100 liters of sterile production medium selected from one of the following: ______________________________________MEDIUM IIngredient Amount (g/L)______________________________________Peanut meal 10.0Soluble meat peptone 5.0Sucrose 20.0KH.sub.2 PO.sub.4 0.5K.sub.2 HPO.sub.4 1.2MgSO.sub.4 . 7H.sub.2 O 0.25Tap water q.s. to 1 liter______________________________________ The pH of the medium is about 6.9 after sterilization by autoclaving at 121° C. for 45 minutes at about 16-18 psi. ______________________________________MEDIUM IIIngredient Amount (g/L)______________________________________Sucrose 30.0Peptone 5.0K.sub.2 HPO.sub.4 1.0KCl 0.5MgSO.sub.4 . 7H.sub.2 O 0.5FeSO.sub.4 . 7H.sub.2 O 0.002Deionized water q.s. to 1 liter______________________________________ Adjust to pH 7.0 with HCl; after autoclaving, pH is about 7.0. ______________________________________MEDIUM IIIIngredient Amount (g/L)______________________________________Glucose 20.0NH.sub.4 Cl 3.0Na.sub.2 SO.sub.4 2.0ZnCl.sub.2 0.019MgCl.sub.2 . 6H.sub.2 O 0.304FeCl.sub.3 . 6H.sub.2 O 0.062MnCl.sub.2 . 4H.sub.2 O 0.035CuCl.sub.2 . 2H.sub.2 O 0.005CaCO.sub.3 6.0KH.sub.2 PO.sub.4 * 0.67Tap water q.s. to 1 liter______________________________________ *Sterilized separately and added aseptically Final pH about 6.6. The inoculated production medium is allowed to ferment in a 165-liter fermentation tank at a temperature of about 30° C. for about 42 hours. The fermentation medium is stirred with conventional agitators at about 200 RPM and aerated with sterile air to maintain the dissolved oxygen level above 30% of air saturation at atmospheric pressure. B. Deacylation of Antibiotic S31794/F-I A fermentation of A. utahensis is carried out as described in Sect. A, using production medium I. After the culture is incubated for about 48 hours, antibiotic S31794F-1, dissolved in a small amount of methanol, is added to the fermentation medium. Deacylation of S31794/F-1 is monitored by paper-disc assay against Candida albicans. The fermentation is allowed to continue until deacylation is complete as indicated by disappearance of activity. C. Isolation of S31794/F-1 Nucleus Whole fermentation broth, obtained as described in Sect. B is filtered. The mycelial cake is discarded. The clear filtrate thus obtained is passed through a column containing HP-20 resin (DIAION High Porous Polymer, HP-Series, Mitsubishi Chemical Industries Limited, Tokyo, Japan). The effluent thus obtained is discarded. The column is then washed with up to eight column volumes of deionized water at pH 6.5-7.5 to remove residual filtered broth. This wash water is discarded. The column is then eluted with a water:methanol (7:3) solution. Elution is monitored using the following procedure: Two aliquots are taken from each eluted fraction. One of the aliquots is concentrated to a small volume and is treated with an acid chloride such as myristoyl chloride. This product and the other (untreated) aliquot are assayed for activity against Candida albicans. If the untreated aliquot does not have activity and the acylated aliquot does have activity, the fraction contains S31794/F-1 nucleus. The eluate containing S31794/F-1 nucleus is concentrated under vacuum to a small volume and lyophilized to give crude nucleus. D. Purification of S31794F-1 Nucleus by Reversed-Phase Liquid Chromatography Crude S31794/F-1 nucleus, obtained as described in Section C, is dissolved in water:acetonitrile:acetic acid:pyridine (96:2:1:1). This solution is chromatographed on a column filled with Lichroprep RP-18, particle size 25-40 microns (MC/B Manufacturing Chemists, Inc. E/M, Cincinnati, OH). The column is part of a Chromatospac Prep 100 unit (Jobin Yvon, 16-18 Rue du Canal 91160 Longjumeau, France). The column is operated at a pressure of 90-100 psi, giving a flow rate of about 60 ml/minute, using the same solvent. Separation is monitored at 280 nm using a UV monitor (ISCO Absorption Monitor Model UA-5, Instrumentation Specialties Co., 4700 Superior Ave., Lincoln, Nebraska 68504) with an optical unit (ISCO Type 6). On the basis of absorption at 280 nm, fractions containing S31794/F-1 nucleus are combined, evaporated under vacuum and lyophilized to give purified S31794/F-1 nucleus. EXAMPLE 4 Preparation of Antibiotic S31794/F-1 Antibiotic S31794/F-1 is produced by submerged culture of Acrophialophora limonispora NRRL 8095 with stirring, shaking, and/or aeration at pH 3-8, preferably pH 5-7, and at 15°-30° C., preferably at 18°-27° C., for from 48 to 360 hours, preferably from 120 to 288 hours. Antibiotic S31794/F-1 is isolated by treating the culture broth (90 L) with ethyl acetate:isopropanol (4:1, 90 L) and homogenizing for 30 minutes at room temperature. The organic phase is separated and evaporated under vacuum at about 40° C. The residue thus obtained is chromatographed on a 10-fold amount of silica gel, using CHCl 3 :CH 3 OH (95:5 to 60:40). Fractions which have antifungal activity are combined and chromatographed on a 100-fold amount of "Sephadex LH-20" with methanol. Fractions from the Sephadex column which have antifungal activity are combined and rechromatographed on a 100-fold amount of silica gel (0.05-0.2 mm) with a CHCl 3 :CH 3 OH:H 2 O (71:25:4) solvent system. The fractions eluted which have antifungal activity are combined and evaporated under vacuum to give crude antibiotic S31794/F-1. This product is dissolved in small amounts of methanol and precipitated with diethyl ether to give S31794/F-1 as a white amorphous powder, mp 178°-180° C. (dec.) after drying in high vacuum at 25°-30° C. Crystallization from a 10-fold amount of ethyl acetate:methanol:water (80:12:8) gives crystalline S31794/F-1, mp 181°-183° C. (dec) after drying in high vaccuum at 20° C. EXAMPLE 5 Isolation of Antibiotic S31794/F-1 Crude antibiotic S31794/F-1, obtained as described in Example 4 after chromatography over Sephadex, is introduced onto a silica-gel column (Michel-Miller Column) through a loop with the aid of a valve system. The column is packed with LP-1/C 18 silica-gel reversed-phase resin (10-20 microns), prepared as described in Example 6, in chloroform:methanol:water (71:25:4) through a loop with the aid of a valve system. The slurry packing procedure described in Example 7 is used. The solvent is moved through the column using an F.M.I. pump with valveless piston design. Elution of the antibiotic is monitored using a UV monitor at 280 nm as in Example 3. Fractions having antifungal activity are combined and concentrated under vacuum to give antibiotic S31794/F-1. S31794/F-1 has R f values as follow on silica-gel thin-layer chromatography (Merck, 0.25 mm): ______________________________________Solvent System R.sub.f Value______________________________________Chloroform:methanol:water (71:25:4) 0.17Chloroform:methanol:conc. acetic acid(70:29:1) 0.19Chloroform:methanol (2:1) 0.27______________________________________ S31794/F-1 can also be detected by iodine vapor. EXAMPLE 6 Preparation of Silica Gel/C 18 Reversed Phase Resin Step 1: Hydrolysis LP-1 silica gel (1000 g from Quantum Corp., now Whatman) is added to a mixture of concentrated sulfuric acid (1650 ml) and concentrated nitric acid (1650 ml) is a 5-L round-bottom flask and shaken for proper suspension. The mixture is heated on a steam bath overnight (16 hours) with a water-jacketed condenser attached to the flask. The mixture is cooled in an ice bath and carefully filtered using a sintered-glass funnel. The silica gel is washed with deionized water until the pH is neutral. The silica gel is then washed with acetone (4 L) and dried under vacuum at 100° C. for 2 days. Step 2: First Silylation The dry silica gel from Step 1 is transferred to a round-bottom flask and suspended in toluene (3.5 L). The flask is heated on a steam bath for 2 hours to azeotrope off some residual water. Octadecyltrichlorosilane (321 ml, Aldrich Chemical Company) is added, and the reaction mixture is refluxed overnight (16 hours) with slow mechanical stirring at about 60° C. Care is taken so that the stirrer does not reach near the bottom of the flask. This is to prevent grinding the silica gel particles. The mixture is allowed to cool. The silanized silica gel is collected, washed with toluene (3 L) and acetone (3 L), and then air-dried overnight (16-20 hours). The dried silica gel is suspended in 3.5 L of acetonitrile:water (1:1) in a 5-L flask, stirred carefully at room temperature for 2 hours, filtered, washed with acetone (3 L) and air-dried overnight. Step 3: Second Silylation The procedure from the first silylation is repeated using 200 ml of octadecyltrichlorosilane. The suspension is refluxed at 60° C. for 2 hours while stirring carefully. The final product is recovered by filtration, washed with toluene (3 L) and methanol (6 L), and then dried under vacuum at 50° C. overnight (16-20 hours). EXAMPLE 7 Slurry Packing Procedure for Michel-Miller Columns General Information This procedure is employed for packing silica gel C 18 reversed phase resin such as that prepared by the method of Example 6. Generally, a pressure of less than 200 psi and flow rates between 5-40 ml/minute are required for this slurry packing technique; this is dependent on column volume and size. Packing pressure should exceed the pressure used during actual separation by 30-50 psi; this will assure no further compression of the adsorbent during separation runs. A sudden decrease in pressure may cause cracks or channels to form in the packing material, which would greatly reduce column efficiency. Therefore, it is important to let the pressure drop slowly to zero whenever the pump is turned off. The approximate volume of columns (Ace Glass Cat. No., unpacked) are No. 5795-04, 12 ml; No. 5795-10, 110 ml; No. 5795-16, 300 ml; No. 5795-24, 635 ml; and No. 5796-34, 34 ml. The time required to pack a glass column will vary from minutes to several hours depending on column size and the experience of the scientist. Example: 1. Connect glass column to a reservoir column via coupling (volume of reservoir column should be twice that of the column). Place both columns in vertical positions (reservoir column above). 2. Weigh out packing material (ca. 100 g for 200 ml column). 3. Add ca. five volumes of solvent to packing material; use a mixture of 70-80% methanol and 20-30% water. 4. Shake well until all particles are wetted, let stand overnight or longer to assure complete soaking of particles by solvent. Decant supernatant liquid. 5. Slurry the resin with sufficient solvent to fill reservoir column. Pour swiftly into reservoir. The column must be pre-filled with the same solvent and the reservoir column should be partly filled with solvent before slurry is poured. The use of larger slurry volumes may also provide good results; however, this will require (a) larger reservoir or (b) multiple reservoir fillings during the packing procedure. 6. Close reservoir with the Teflon plug beneath the column (see FIG. 1 of U.S. Pat. No. 4,131,547, plug No. 3); connect to pump; and immediately start pumping solvent through system at maximum flow rate if Ace Cat. No. 13265-25 Pump or similar solvent-delivery system is used (ca. 20 ml/minute). 7. Continue until column is completely filled with adsorbent. Pressure should not exceed maximum tolerance of column during this operation (ca. 200 psi for large columns and 300 psi for analytical columns). In most cases, pressures less than 200 psi will be sufficient. 8. Should pressure exceed maximum values, reduce flow-rate; pressure will drop. 9. After column has been filled with adsorbent, turn off pump; let pressure drop to zero; disconnect reservoir; replace reservoir with a pre-column; fill pre-column with solvent and small amount of adsorbent; and pump at maximum pressure until column is completely packed. For additional information, see general procedure. Always allow pressure to decrease slowly after turning off pump--this will prevent formation of any cracks or channels in the packing material. 10. Relieve pressure and disconnect pre-column carefully. With small spatula remove a few mm (2-4) of packing from top of column; place 1 or 2 filter(s) in top of column; gently depress to top of packing material, and place Teflon plug on top of column until seal is confirmed. Connect column to pump, put pressure on (usually less than 200 psi) and observe through glass wall on top of column if resin is packing any further. If packing material should continue to settle (this may be the case with larger columns), some dead space or channelling will appear and step 9 should be repeated.

Compounds of the formula ##STR1## wherein R 1 is an N-alkanoyl amino acyl group of the formula ##STR2## wherein: W is a divalent aminoacyl radical of the formula: ##STR3## wherein A is C 1 -C 10 alkylene or C 5 -C 6 cycloalkylene; ##STR4## wherein R 3 is hydroxymethyl, hydroxyethyl, mercaptomethyl, mercaptoethyl, methylthioethyl, 2-thienyl, 3-indolemethyl, phenyl, benzyl, or substituted phenyl or substituted benzyl in which the benzene ring thereof is substituted with chloro, bromo, iodo, nitro, C 1 -C 3 alkyl, hydroxy, C 1 -C 3 alkylthio, carbamyl, or C 1 -C 3 alkylcarbamyl; ##STR5## wherein X is hydrogen, chloro, bromo, iodo, nitro, C 1 -C 3 alkyl, hydroxy, C 1 -C 3 alkoxy, mercapto, C 1 -C 3 alkylthio, carbamyl, or C 1 -C 3 alkylcarbamyl; ##STR6## wherein X 1 is chloro, bromo, or iodo; ##STR7## wherein B is a divalent radical of the formula: --(CH 2 ) n --, wherein n is an integer from 1 to 3; --CH═CH--; --CH═CH--CH 2 --; or ##STR8## and R 2 is C 1 -C 17 alkyl or C 2 --C 17 alkenyl; have antifungal activity.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application claims priority from the following copending patent applications: application Ser. No. 09/915,226, filed Jul. 23, 2001; application Ser. No. 09/638,805, filed Aug. 12, 2000; application Ser. No. 09/562,599, filed Apr. 29, 2000; provisional application Ser. No. 60/255,635, filed Dec. 13, 2000; application Ser. No. 09/851,400, filed May 7, 2001; provisional application Ser. No. 60/323,923, filed Sep. 15, 2001 and PCT application no. PCT/US01/25197 filed Aug. 10, 2001. The entire disclosure of each of the above-referenced patent applications is expressly incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The invention relates to forming anastomoses between two hollow bodies, and more specifically, using magnetic force to form such anastomoses. [0004] 2. Description of Related Art [0005] Various non-suture based anastomotic systems have been proposed in the art, however, none has performed well enough to receive any significant level of acceptance in the field. Many of the proposed couplings fail to remain sufficiently patent, either acutely or chronically. Another technical challenge is to create an anastomosis that produces a fluid-tight seal between the hollow bodies. This is due in large part to the difficulty in securing an anastomotic component without overly traumatizing the tissue and without placing too much foreign material in the vessel lumen. SUMMARY OF THE INVENTION [0006] One embodiment of the invention provides an anastomotic component that is coupled or attached to the wall of a vessel without protruding into the lumen of the vessel or penetrating the vessel wall. That is, substantially none of the anastomotic component or assembly is located within the vessel lumen (i.e., after the anastomosis has been formed). As a result, there is preferably no foreign structure or material disposed within the target vessel lumen after creating the anastomosis. [0007] The specific manner in which the anastomotic component is secured to the vessel may vary according to the invention. In one embodiment biocompatible adhesive is used to secure a component to the exterior of the target vessel wall without extending into the lumen. This component is coupled to a magnetic or ferromagnetic assembly carried on a graft vessel. Another embodiment uses adhesive to secure the anastomotic components to both vessels. [0008] According to further embodiments magnetic force is used in combination with an additional locking force, for example, a mechanical connection, to maintain the vessels in proper position and provide heightened resistance to pressure fluctuations that might occur post-formation of the anastomosis. Alternative constructions for the anastomotic components are disclosed, as are various delivery devices and methods for deploying the components. BRIEF DESCRIPTION OF THE DRAWING FIGURES [0009] Other features, benefits and advantages of the present invention will be apparent from the following detailed description of preferred embodiments thereof taken in conjunction with the accompanying drawing figures, wherein: [0010] FIGS. 1A and 1B are, respectively, plan and elevation views of a magnetic anastomotic component constructed according to one embodiment of the invention; [0011] FIG. 1C is an elevation view of a magnetic anastomotic component constructed according to an alternative embodiment of the invention; [0012] FIGS. 2A and 2B are, respectively, perspective and elevation views of a magnetic anastomotic component constructed according to another embodiment of the invention; [0013] FIGS. 3A and 3B are, respectively, perspective and elevation views of a magnetic anastomotic component constructed according to yet another embodiment of the invention; [0014] FIG. 4 is a perspective view showing the anastomotic component of FIGS. 3A and 3B attached to a vessel; [0015] FIGS. 5A and 5B are perspective views showing an anastomotic component being secured to a vessel according to another embodiment of the invention; [0016] FIGS. 6A-6C are elevation views showing anastomotic components constructed according to different embodiments of the invention being used to form an anastomosis between two vessels; [0017] FIGS. 7A-7C are elevation views showing an anastomotic component being secured to a vessel according to another embodiment of the invention; [0018] FIG. 7D is an elevation view showing the component of FIGS. 7A-7C being secured to an end of a vessel; [0019] FIGS. 8A and 8B are perspective views of magnetic anastomotic components provided with tissue anchoring elements according to another embodiment of the invention; [0020] FIGS. 9A-9C are elevation views, in section, showing magnetic anastomotic components provided with tissue traction-enhancing structure according to another embodiment of the invention; [0021] FIGS. 10A-10C are, respectively, perspective views and a sectional view of one of the magnetic anastomotic components shown in FIG. 9C ; [0022] FIGS. 11A and 11B are, respectively, plan and sectional views of a magnetic anastomotic component provided with tissue gripping structure according to another embodiment of the invention; [0023] FIG. 11C is a sectional view of an anastomotic component having an alternative tissue gripping structure; [0024] FIGS. 12A-12D are, respectively, perspective, side elevation, end elevation and plan views of a magnetic anastomotic component constructed according to another embodiment of the invention; [0025] FIGS. 13A-13C are, respectively, perspective, side elevation and end elevation views of an anastomosis formed by a pair of magnetic anastomotic components constructed according to another embodiment of the invention; [0026] FIGS. 14A-14D are, respectively, plan, perspective, end elevation and side elevation views of a magnetic anastomotic component constructed according to another embodiment of the invention; [0027] FIGS. 15A-15D are, respectively, plan, perspective, end elevation and side elevation views of a magnetic anastomotic component having a similar construction as the component shown in FIGS. 14A-14D ; [0028] FIGS. 16A-16B perspective views showing an anastomotic component being mounted to the exterior surface of a hollow body according to one embodiment of the invention; [0029] FIGS. 16C-16D perspective views showing an anastomotic component being mounted to the exterior surface of a hollow body according to one embodiment of the invention; [0030] FIGS. 17A and 17B are, respectively, perspective and end elevation views of an extravascular anastomosis created according to one embodiment of the invention; [0031] FIGS. 18A-18D are perspective views showing an anastomotic component being mounted to the exterior surface of a hollow body according to another embodiment of the invention; and [0032] FIG. 19 is an end elevation view of a magnetic anastomotic component mounted to the exterior of a vessel according to one embodiment of the invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0033] FIGS. 1A and 1B show a first embodiment of a magnetic anastomotic component 10 having a ring-shaped body 12 and an opening 14 . As shown in FIG. 1B the component body 12 is generally flat. However, as shown in FIG. 1C , the body 12 may be curved, for example, to match the curvature of a vessel to which it is secured. [0034] FIG. 2A shows a magnetic anastomotic component 16 with an opening 18 . The body of the component 16 has an oval or elliptical shape with leading edges 20 for facilitating atraumatic introduction into a vessel. As shown in FIG. 2B , the component 16 is flat. As in the above embodiment, however, the component 16 could be curved instead, for example, in a manner similar to the curvature of the anastomotic component 22 shown in FIGS. 3A-3B . Also, the curvature may extend over all or a portion of the length (or width) of the component. [0035] FIG. 4 shows the anastomotic component 22 of FIGS. 3A and 3B mounted on the side wall of a vessel V. According to the preferred embodiments, the component is secured to the vessel without projecting into the vessel lumen, thereby avoiding potential problems associated with foreign material located in the vessel lumen. The component may be secured to the exterior of the vessel by suitable means, for example, adhesive, mechanical fasteners, or both. [0036] FIGS. 5A and 5B show the anastomotic component 16 of FIGS. 2A and 2B mounted on a side wall of a vessel V. FIG. 5B shows mechanical fastening means, the illustrated means being in the form of sutures S, which are used to attach the component 16 to the vessel V. While sutures S are shown, it will be recognized that any suitable mechanical fastener may be used, e.g., clips, stents, barbs, hooks, wires, etc. [0037] In the embodiments of FIG. 4 and FIGS. 5A-5B , the anastomotic component is secured to the exterior of the vessel wall by suitable means. FIGS. 6A and 6B show anastomoses between two vessels V 1 and V 2 . In FIG. 6A , the vessels have mounted thereto, respectively, magnetically attracted anastomotic components 24 , 26 . (For clarity, the components are shown slightly separated.) The components 24 , 26 are rectangular in cross-section. In FIG. 6B the vessels V 1 , V 2 have mounted thereto, respectively, components 28 , 30 . The components 28 , 30 are provided with a curved exterior surface that generally corresponds to the curvature of the walls of vessels V 1 and V 2 . [0038] The anastomoses shown in FIGS. 6A and 6B are created without placing any component portion in the vessel lumen. FIG. 6C shows an embodiment wherein a vessel V 1 has an anastomotic component 32 secured thereto, while a vessel V 2 has an anastomotic component comprising portions 34 A and 34 B secured thereto. Unlike the embodiments of FIGS. 6A and 6B , thought, the portion 34 B of the one component is disposed within the lumen of vessel V 2 . [0039] FIG. 7A shows a vessel V prior to forming an opening in the wall thereof. FIG. 7B shows the vessel V after an opening O has been formed therein. FIG. 7C shows an anastomotic component 36 positioned around the outside of the opening in the vessel V. An internal locking member 38 , which may be in the form of a snap ring, is positioned within the vessel lumen and cooperates with a groove in component 36 to secure the vessel and component together. FIG. 7D shows an anastomotic component 40 positioned around the end of a vessel V. The internal locking component 38 cooperates with a groove in the component 40 to secure the component to the end of the vessel (as opposed to the side wall of the vessel, as in the previous embodiments). [0040] FIG. 8A shows a magnetic anastomotic component 42 having an opening 44 and a pair of attachment tabs 46 with openings 48 . The component 42 is mounted to the exterior of a vessel (not shown), for example, by passing a fastener (also not shown) through each opening 48 into engagement with the vessel tissue. Alternatively, the tabs 46 and openings 48 may be used as secondary securing means, for example, if the component 42 is secured to the vessel by other means, e.g., adhesive. [0041] FIG. 8B shows a magnetic anastomotic component 50 having an opening 52 and attachment structure 54 to facilitate securing the component to a vessel (not shown). As above, the structure 54 may be used alone or in combination with other means for securing the component to the vessel. In the illustrated embodiment, the attachment structure 54 is affixed to the component 50 to define a plurality of openings 56 which may be use to receive sutures, clips, clamps, pins, barbs, or other securing or fastening means. [0042] One benefit of the embodiments of FIGS. 8A-8B and 9 A- 9 B is that the attachment structure is disposed away from (or below) the magnetic coupling surface of the component. That is, the exposed surface of the first component is free to mate with the exposed surface of the second component without interference from the attachment structure. As a result, one or both components can be firmly affixed to its vessel without adversely affecting the anastomosis. [0043] FIGS. 9A-9C show three embodiments of magnetic anastomotic components that are provided with structure for increasing the traction or gripping force between the components and a vessel to which they are secured. In FIG. 9A , anastomotic component portions 58 A, 58 B sandwich a vessel wall W and are preferably provided with a layer of material to enhance engagement with the tissue. FIG. 9B shows component portions 60 A and 60 B, each of which includes a projection 62 at the end thereof which grabs the tissue of the vessel wall W, thereby enhancing securement. FIG. 9C shows anastomotic component portions 64 A and 64 B, each of which is provided with a series of grooves or annulations 66 that grippingly engage the tissue of the vessel wall W. [0044] FIGS. 10A-10C show an anastomotic component 68 with an opening 70 and a plurality of grooves or bumps 72 . The grooves or bumps 72 , which may also be in the forms of ridges, serrations, sharp or dull edges, etc., grab the tissue of the vessel to which the component is secured, which provides additional attachment force. FIG. 10C shows the ridges 72 having sharp points 74 to further enhance engagement with the tissue. [0045] FIGS. 11A-11C show a magnetic anastomotic component 74 with an opening 76 and a peripheral edge 76 that defines a sharp point 78 . As shown in FIG. 11B , a second anastomotic component 80 may be used with the component 74 , the component 80 having a complimentary-shaped edge 82 which cooperates with the edge 76 to sealingly and grippingly grab tissue of a vessel to which the components are secured. FIG. 11C shows a variation of the component 74 wherein a plurality of edges 74 ′ and 76 ′ are provided. A modified second component 80 ′ has a plurality of complimentary edges 82 ′ that mate with the edges 76 ′ of component 74 ′. In each of these embodiments the force-increasing structure is shown running along the entire length of the component. It will be appreciated that such structure may be extend along all or any portion of the component, and could extend across the width or longitudinal axis of the component, rather than along the axis, as in FIGS. 10A-10C . [0046] The attachment force-increasing embodiments of FIGS. 9A-9C , 10 A- 10 C and 11 A- 11 C provide several benefits. In addition to enhancing attachment of the component to the vessel, the resulting anastomosis may have higher resistance to bursting under high pressures, e.g., acute pressure increases. For example, placing a rough or bumpy parylene coating on the surface of a magnetic component produces higher burst pressure resistance than using a smooth surface. It is desirable to increase pressure resistance, preferably without increasing the risk of occlusion. [0047] According to the invention, the components described above may be secured to the vessel by various means. For example, the component may be adhesively attached to the exertion of the vessel so that the lumen of the vessel is free of any component portion. In addition to the adhesive securement of the component, any of the above-described traction or tissue-gripping structure may be used as well. Additionally, the component may be provided with tabs or other attachment structure as described above. [0048] FIGS. 12A-12D show a magnetic anastomotic component 84 having a rounded configuration designed to mate with the curvature of a vessel, and an opening 86 adapted to communicate with the vessel lumen. The thickness of the component 84 is tapered across its width ( FIG. 12C ) and may be tapered more or less from the specific configuration shown. [0049] FIGS. 13A-13C show an anastomosis created according to another embodiment of the invention. A first vessel V 1 and a second vessel V 2 are provided with respective magnetically-attracted components 88 , 90 . The component 88 has an intravascular portion 92 and an extravascular portion 94 , while the component 90 has an intravascular portion 96 and an extravascular portion 98 as shown best in FIGS. 13A and 13C . The extravascular portions 94 , 98 of the respective components are flat and provide a flat engagement to enhance the magnetic force holding the components together. [0050] FIGS. 14A-14D show a magnetic anastomotic component 100 having a luminal opening 102 and a plurality of slots 104 . The slots 104 serve any of several purposes including allowing tissue ingrowth to promote attachment to the vessel, enhance traction between the component 100 and the vessel to which it is attached, etc. [0051] FIGS. 15A-15D show a magnetic anastomotic component 106 with a luminal opening 108 and a plurality of apertures 110 disposed around its perimeter. The apertures 110 give the component 106 a frame-like structure and may serve any of the purposes described above with respect to the previous embodiment. It will be noted that the components 106 and 100 , while illustrated as being curved to match the curvature of a vessel or mating component (not shown), they may instead be flat or otherwise configured. [0052] FIGS. 16A and 16B show a magnetic anastomotic component 112 being attached to a vessel V according to one embodiment of the inventions. An opening O is formed in an opening of a side wall of the vessel V and a magnetic anastomotic component 112 is moved into position such that the luminal 114 of the component is aligned with the opening O ( FIG. 16B ). [0053] FIGS. 16C and 16D show a magnetic anastomotic component 116 being secured to a vessel V according to another embodiment of the invention. In this embodiment, the component 116 is lowered against and secured to the vessel wall as in the above embodiment. However, an opening is formed in the vessel after placing the component in this embodiment. As shown in FIG. 17B , a suitable instrument is used to remove the tissue circumscribed by the opening 116 of the component 116 . The components 112 and 116 may be secured to the exterior of the wall of vessel V by any suitable means disclosed herein. [0054] FIG. 17A shows an anastomosis between first and second vessels V 1 and V 2 which are provided, respectively, with magnetically attracted components 120 , 122 . As shown in FIG. 17B , of the components 120 , 122 have mating surfaces which are positioned against each other and held by magnetism to create the anastomosis. [0055] FIGS. 18A-18D show a magnetic anastomotic component being secured to the exterior of a vessel wall according to still another embodiment of the invention. Delivery device D includes an internal placement member 130 which is used to place a magnetic anastomotic component 132 . The placement member 130 is positioned within the lumen of the vessel through an incision in the wall, and the anastomotic component 132 is slid down against the exterior of the vessel. Magnetic attraction holds the component 132 in position around the incision. [0056] It should be noted that in positioning the placement member within the lumen of the vessel v, the delivery device is manipulated, typically by pulling up to tension the vessel wall, and the edges of the incision are positioned around a portion 134 of the delivery device D so as to make the incision the desired size. When the edges of the incision are so positioned, the anastomotic component 132 is slid down and the magnetic attraction captures the edges of the incision, thereby maintaining a suitable size opening. [0057] Next, the delivery device D is removed as shown in FIG. 18C . Finally, as shown in FIG. 18D , the internal placement member 130 is pushed distally and rotated and then removed (for example, by wires W) through the incision in the vessel V. The magnetic anastomotic component 132 is preferably provided with adhesive to secure the component to the vessel. Alternatively, adhesive may be applied around the incision on the vessel and the component 132 moved into contact therewith. [0058] FIG. 19 shows an embodiment of the invention where a magnetic anastomotic component 136 is secured to an intermediate member 138 , for example a dacron blanket, which itself is secured to the wall of a vessel V. These embodiments may be practiced by forming a blanket or surface of adhesive on the vessel exterior, and then forming the incision through the adhesive (which may be less difficult than incising the vessel wall directly). [0059] The invention may be practiced using any suitable biocompatible adhesives. In general, fibrin sealants and cyanoacrylate esters are the two types of adhesives widely used for biological bonding. Gelatin-resorcinol-formaldehyde glues have limited use as well. Other possible bioadhesives include gelatin-resorcinol-formaldehyde glue, bovine albumin, glutaraldehyde, marine organism (mussel) based, collagen and thrombin. [0060] Fibrin sealants are biodegradable, adhere well to connective tissue, promote wound healing, and generally have less bond strength than cyanoacrylate esters. A two-part system may be used to apply the sealant, or a one-part, ready-to-use formulation may be used instead. The adhesives used may have or not have antifibrinolytic agents (e.g., aprotinin, etc.) [0061] Those skilled in the art will recognize that many modifications, alterations and variations of the illustrated embodiments may be made without departing from the scope and spirit of the invention as defined by the appended claims. For example, while the embodiments are described in connection with magnetic anastomotic components, it will be appreciated that various features of the invention may be practiced in conjunction with non-magnetic anastomotic components. Further, it will be appreciated that, independent of the specific illustrated embodiments, the components disclosed herein may be used to create end-to-end, end-to-side or side-to-side anastomoses, between blood vessels or any hollow anatomical structures.

Methods and devices using magnetic force to form an anastomosis between hollow bodies. End-to-side, side-to-side and end-to-end anastomoses can be created without using suture or any other type of mechanical fasteners, although such attachment means may be used in practicing some aspects of the invention. Magnetic anastomotic components may be attached to the exterior of a vessel, e.g., by adhesive, without extending into the vessel lumen. Various magnetic component configurations are provided and may have different characteristics, for example, the ability to match the vessel curvature or to frictionally engage the vessel.

BACKGROUND OF THE INVENTION This invention relates to a toy construction kit for building wet sand structures. The toy construction kit includes sets of building modules for casting supportable sand components in making large and elaborate sand structures. Children enjoy playing in the sand at the beach, or in a playground or home "sandbox." Particular enjoyment is derived from building sand castles and other sand structures from wet or damp sand. Building large or complex sand structures often requires an artistic talent and dexterity not possessed by young children. In fact, such structures are frequently built by young adults, often in teams, during competitions. As the wet sand begins to dry, the sand structure crumbles under its own weight, often before the entire structure is completed. To provide younger children with the means to produce large, imposing structures in a short period of time, casting pails are frequently used. By packing sand in a sand pail, and inverting the pail at the desired location, elements of a structure can be completed quickly before appreciable drying occurs. While this method is popular with young children, the inability to construct tall and complex structures leads to disinterest and boredom. In order to provide young children and enthusiastic adults with a challenge in building cast sand structures, the toy construction kit of this invention was devised. The primary problem with the use of existing pail cast structures is the inability to stack castings or span between castings. The toy construction kit of this invention solves the problems of existing sand casting kits that merely provide a series of different molds, and provides structural elements to greatly expand the type and size of structures buildable using the toy construction kit. The toy construction kit is designed as an educational tool to both develop motor skills and conceptualization. Building integrated structures from a set of modules requires a gradual increase in dexterity as the structures increase in complexity. The toy construction kit was primarily designed for use with wet sand, but any compactible material, such as snow can be used with the construction kit. In summer or winter, hours of enjoyment can be provided with the toy construction kit of this invention. SUMMARY OF THE INVENTION The toy construction kit of this invention relates to a system for building wet sand structures. The system includes, not only a set of sand molds, but additional structural elements that enables the cast sand modules to be stacked and spanned in a variety of different composite structures. It is contemplated that the toy construction kit can be marketed as a simple starter kit with one or more different mold configurations, and also in more elaborate sets including a variety of different molds. The construction kit includes at least one support plate, a support post connectable to the support plate, and a forming mold into which sand is packed around the support post. The mold may be a simple container similar to the shape of a sand bucket with a post recess for positioning the support post prior to filling with sand. Once sand is filled in the mold, the support plate having a similar post recess is connected to the distal end of the support post which has a length equal to the depth of the container. With the support plate engaged on the support post, the mold is inverted and the support disengaged from the recess in the mold to assist in maintaining the integrity of the sand module which may be lifted by the support plate and located as desired in the structure being built. In addition to the three basic components, small connecting clips are provided to interconnect a plurality of sand modules by interconnecting the support plates supporting the sand casting. The support clips comprise a small tab with a plurality of short projecting posts that selectively engage one of a series of complementary post recesses in the perimeter of the support plate. In some embodiments an interconnecting plate may be employed to substitute for one or more support clips. It can be appreciated that although only a single mold need be provided for each casting shape, a plurality of complimentary support plates and support posts are provided to enable the casting mold to produce a plurality of sand modules. In the preferred embodiments, a plurality of different mold configurations is shown as examples of the type of variety of geometrically-shaped, mold configurations that may be provided with the construction kit, and is not intended to limit the invention to the specific mold configurations shown. As it is intended that a number of sand cast modules be stacked in a spanning fashion, the construction kit in general includes both a support plate for the top as well as the bottom of the cast sand module. In this manner, the weight of the sand module is directed from the base plate of one module to the top plate of the underlying module and hence to the centrally positioned support post. This prevents the weight of other modules from crumbling the sand casting of the lower modules. These and other features will become clear from a consideration of the Detailed Description of the Preferred Embodiments that follows. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a sand structure constructed with the sand casting kit of this invention. FIG. 2 is a partially exploded view of a kit module with a pyramid-shaped mold for making mold castings used in the structure of FIG. 1. FIG. 3 is an enlarged, partial cross-sectional view of the pyramid-shaped mold of FIG. 2, taken on the lines 3--3 in FIG. 3. FIG. 4 is an exploded perspective view of a kit module with a bucket-shaped mold. FIG. 5 is an exploded perspective view of a kit module with a cylinder-shaped mold. FIG. 6 is an exploded cross-sectional view of a kit module with a hemispherical-shaped mold. FIG. 7 is an exploded cross-sectional view of a kit module with a truncated pyramid-shaped mold. FIG. 8 is an exploded cross-sectional view of a kit module with a hanger-like mold. FIG. 9 is an exploded cross-sectional view of an alternate post and plate arrangement. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The toy construction kit for sand structures of this invention may take many different configurations. FIG. 1 shows an example of one type of structure that can be built by one of the molds in the construction kit. The multi-tier pyramid structure, designated generally by the reference numeral 10, is made with a four-sided, truncated pyramid module set 12 as shown in FIG. 2. With reference to FIGS. 1-3, the pyramid module set 12 includes a sand mold 14, a plurality of square support plates 16, a plurality of support posts 18 and a plurality of caps 20. For convenience, only one support plate, post and cap is shown in FIG. 2. A sufficient number of these elements should be provided to construct complex structures as shown in FIG. 1. It is to be understood that different sand castings made from molds of different configurations can be combined into an integrated structure. For simplicity of description, the structure 10 of FIG. 1 incorporates a plurality of pyramid sand castings 22 that are formed by casting with the mold 14 shown in FIG. 2. The pyramid mold 14 in FIG. 2 has an apex 24 with an internal construction as shown in FIG. 3. The pyramid mold 14 is fabricated with four substantially triangular plates 26 that are interconnected along opposed edges with a small inside projection 28 positioned in each corner at the apex 24. The projection 28 seats a cap 20 and support post 18 when inverted for filling with sand when the casting is intended to support other castings. The top casting 22a is made without the cap 20. In fabricating a sand casting from the pyramid module set 12 of FIG. 2, the pyramid mold 14 is inverted and the post 18 and cap 20 are positioned on the apex projections 28. Wet or damp sand is then packed in the inverted mold around the support post 18 flush with the perimeter edges 34 of the open pyramid mold 14. It is to be understood that other compactible materials such as snow may be utilized. The support plate 16 has a centrally positioned socket member 36 with a recess 38 to receive the distal end 40 of the support post 18. While the filled mold 14 is inverted, the support plate 16 is oriented to direct the recess 38 of the socket member 36 at the distal end 40 of the installed support post 18. While orienting the edges 42 of the support plate 16 in alignment with the perimeter edges 34 of the pyramid mold 14 that define the opening of the mold, the support plate 16 is pressed against the support post 18 to engage the distal end 40 of the support post 18 with the socket member 36 of the support plate. When the sand-packed mold 14 is returned to a right-side position and the mold 14 removed from the support plate 16, the support post 18 and cap 20 form an integral part of the sand casting. The support plate 16 is sufficiently rigid to support the sand casting and enable the casting to be lifted and moved to a desired location by the builder. It is to be understood that the opening for release of the sand casting is equal or greater than the internal cross dimension to enable release of the casting. When the builder constructs a multi-tiered structure as shown in FIG. 1, the top cap 20 remains installed on the distal end 40 of the support post 18. The top cap 20 has a socket portion 44 and a plate portion 46. The plate portion 46 has four short corner pegs 48 that are sized to engage one of the corner holes or dimples 50 in each of a group of plates, enabling the structure 10 as shown in FIG. 1 to be constructed with substantial stability. The top casting 22a is made without using the cap 20 by filling the apex portion above the projections 28 with sand. The post 18 is positioned on the sand and centered while the rest of the mold is filled with sand as described above. As noted, the structure of FIG. 1 is constructed using a single mold and a plurality of plate, post and cap members. Other configurations of a mold are shown with reference to FIGS. 4-8, and the sand castings can be combined and integrated into a variety of different sand structures. Referring to FIG. 5, a mold 54 having the traditional configuration of a common sand pail, is in the form of a truncated cone. In a similar manner, the module set 12 has a circular base plate 56 and a circular top plate 58. Both the base plate 56 and top plate 58 have a centrally positioned socket member 36 which engages a support post 18, as previously described. Again, in use, the conical mold 54 is inverted and the top plate 58 deposited in the bottom 59 of the mold. The support post 18 is installed in the socket member 36 in the top plate 58. Sand is packed into the mold around the post 18 and the base plate 56 pressed against the sand to engage the socket member 36 with the distal end 40 of the post. The mold is then inverted and the casting drops from the mold with the top plate 58 for placement in a desired structure. Small interconnector members 60, similar in construction to the caps 20, but without a socket member, are provided for interconnecting multiple castings. The interconnection member 60 is square in configuration with a small projecting corner peg 48 in the four topside and bottom side corners. The corner pegs engage holes or dimples 62 spaced around the perimeter of the base plate 56 and the top plate 58. As a further variation in a module set, the cylindrical module set 12 of FIG. 5 includes a cylindrical open end mold 64. Identical circular end plates 66 each have a central socket member 36 that engages the end of a support post 18. The inside circumference of the cylindrical mold 64 encompasses the perimeter of one of the circular plates 66 with a centrally mounted post 18. Sand is then packed into the cylindrical mold around the support post until filled. When filled, the opposite end plate 66 is centered and the socket member 36 pressed into engagement with the end of the support post 18. Holding the second attached end plate 66, the mold is drawn upward over the mold plate to expose the cylindrical plug-type casting. The end plates 66 have holes 68 for engaging the interconnector members 60 when composite structures are built. Referring to the cross sectional views of FIGS. 6-8, various other configurations of mold structures can form the basis of a module set 12. In FIG. 6, a hemispherical mold 70 has a internal socket 72 for temporarily retaining a support post 18 when packing sand in the mold 70. A circular base plate 74 has a standard socket 36 that engages the post 18 after the mold 70 has been filled with sand and inverted. In return to the placement position, the mold 70 can be removed and a cap 20 with a socket 44 as disclosed with reference to FIG. 2 may be installed on the post 18 for coupling other mold castings. Similarly, in FIG. 7, a truncated pyramidal mold 78 has a bottom 80 with a socket 82 for temporarily and loosely engaging the post 18 when the mold is inverted and filled with sand. A square base plate 84 having a socket 36 that engages post 18 for supporting the casting when the mold is returned to the casting position and removed from the sand casting. A square top plate 86 with a socket 36 engageable with the post 18 may be installed for support of other castings. Additionally, in FIG. 8 an elongated hangar-like mold 90 having two internal sockets 92 for temporarily holding posts 18 while the mold is inverted and packed with sand. Again, a bottom plate 94 having semi-circular ends 96 with sockets 36 is pressed against the sand filled mold to engage the sockets 36 with the posts 18 for supporting the sand casting. When inverted and the mold 90 is removed, a pair of caps 20 may be installed on the ends of the posts 18 for interconnection of auxiliary castings in the formation of a composite structure. It is to be understood that if desired, that the socket and post construction can be altered, for example as shown in FIG. 9, wherein the post 100 has ends 102 with a bore 104 that receive a pin 106 mounted on top and bottom support plates 108. While, in the foregoing, embodiments of the present invention have been set forth in considerable detail for the purposes of making a complete disclosure of the invention, it may be apparent to those of skill in the art that numerous changes may be made in such detail without departing from the spirit and principles of the invention.

A toy construction kit for constructing sand cast structures using a set of different casting molds, support posts installed in the molds during filling and compacting the sand, and support plates that encompass the open part of the mold and that include a socket to engage the post, the support plate and post supporting the sand casting when the mold is removed the kit including interconnection clips to interconnect the support plates of multiple casting when constructing a multi-tier structure.

FIELD OF THE INVENTION This Invention relates to a bowling alley bumper system and, more particularly, to a bowling alley bumper system wherein the gutter or portion thereof is elevated to prevent a bowling ball from falling into the gutter. BACKGROUND OF THE INVENTION Bowling alley bumper systems have been available since at least as early as 1965. Such systems were designed to be used by children and/or the physically handicapped as well as others who lack the physical coordination or strength to bowl, i.e., project a majority of the balls over the length of the alley without ending up in one of the gutters. Early systems require relatively difficult steps to set up a lane or lanes for so-called "bumper" bowling. For this reason, a number of bowling alley operating personnel were reluctant to promote "bumper" bowling or to encourage children or the handicapped to use the lanes. One approach to overcome the aforementioned problem is disclosed in U.S. Pat. No. 3,401,933 to Conklin et al. That patent discloses a convertible bowling lane having a gutter with a ball receiving surface on one side and a ball deflecting surface on the opposite side and means for moving the gutter between a ball receiving position and a ball deflecting position. As disclosed therein, the gutter is pivotally mounted on a support member which is disposed on the opposite side of the gutter from the bowling lane. The system does present the appearance of a normal bowling alley when in its recessed position, but is relatively complex and somewhat expensive to install. More recently, a bowling alley bumper mechanism such as the one disclosed in U.S. Pat. No. 4,900,024, overcame many of the earlier problems. In such systems, an elongated bumper is mounted alongside and parallel to each alley gutter. The system also include movable supports that permit the extension of the bumpers to guard the gutters when guarding is desired and retraction of the bumpers to expose the gutters when normal alley operation is desired. The Chandler et al. system is less costly and less complex than the Conkiln et al. system, but extends upwardly above the level of the alley even in its recessed position, It also presents an obstacle to walking along the normal capping and may lead to individuals walking on the alley. An improvement to the Chandler et al. system is disclosed in the copending application of C. Dennis Lord. Ser. No. 07/758,003, filed on Sep. 12, 1991,and assigned to the same assignee as the present application. As shown therein, the Chandler et al. system may be constructed to present a more pleasing appearance, but still results in an elevated portion adjacent to the alley which may be objectionable to some bowlers and/or alley owners. It is now believed that the availability of the Chandler et al. type systems, coupled with a change in demographics and business pressures, will encourage bowling alley operators to put more emphasis on bumper bowling to encourage children to learn to bowl, attract families and provide a challenging game for the physically handicapped. For this reason, it is presently believed that there is a demand for an improved bowling alley bumper system which provides a more normal appearance when not in use, is relatively inexpensive to manufacture, easy to install and remove, protects the mechanism from damage and, at the same time, provides ready access to the rear of the lanes without walking on the lanes. It has now been found that an improved bowling alley bumper system in accordance with the present invention provides the aforementioned desirable features. BRIEF SUMMARY OF THE INVENTION In essence, the present invention contemplates an improved bowling alley bumper system wherein the bowling alley can be used for conventional bowling and for bumper or carum bowling. The bowling alley has two sides and a longitudinally extending lane on an upper surface thereof. The alley also includes a foul line at one end thereof and a pin deck at its opposite end. A pair of elongated, concave gutters extend along each side of and in substantially abutting relationship to the alley between the ends thereof for receiving a bowling ball which is directed toward the edge of the alley. i.e.. which falls off of the lane. The bumper system utilizes the gutters or a portion thereof to prevent a bowling ball from falling into gutter. For example, in one embodiment of the invention, each of the gutters define first and second separate longitudinally extending portions with each of the portions having a major axis which is parallel with the major axis of the gutters. Extending and retracting means are provided for moving the gutters or one of the portions in each of the gutters upwardly into an extended position to thereby prevent a bowling ball from falling into one of the gutters and downwardly into a retracted position which allows bowling balls to fall into and roll along one of the gutters. In a preferred embodiment, a first portion of each of the gutters, i.e., the portion adjacent to the alley, is moved upwardly or downwardly along an are in an xz plane with little or no lateral movement, i.e.. little or no movement along its y axis. BRIEF DESCRIPTION OF THE DRAWINGS FIG, 1 is a perspective view of a bowling alley bumper system in accordance with a first embodiment of the invention wherein the bumper system is shown in a recessed position; FIG. 2 is an end view of a portion of the bowling alley bumper system shown in FIG. 1, but with the bumper system shown in its extended position by broken lines; FIG. 3 is a cross-sectional view taken along a--a in FIG. 2; FIG. 4 is an end view of a bowling alley bumper system in accordance with a second embodiment of the invention; and FIG. 5 is a perspective view of a portion of a bowling alley gutter system and illustrating its arc-shaped movement within the xz plane. DESCRIPTION OF THE PREFERRED EMBODIMENT The invention will now be described in connection with the accompanying drawings wherein like reference numerals have been used to designate like parts. As illustrated in FIG. 1, a bowling alley 10 typically includes a longitudinally extending lane 20 which defines a flat horizontal plane on a upper surface thereof and which is typically made up of a plurality of parallel abutting strips of wood 22, 24. The alley includes a foul line 26 which extends across the lane 20 and perpendicular to the longitudinal axis of the lane. The foul line 26 indicates that area beyond which a bowler may not pass in releasing a bowling ball during a game of bowling. A pin deck 28 is disposed at the opposite end of the lane 20 and is adapted to receive a plurality of bowling pins 27 thereon. As shown in FIG. 4, the bowling alley is set with the pins in a customary triangular pattern with one pin, the head pin in front, a second row of two pins, a third row with three pins and a final of our pins. A pair of longitudinally-extending gutters 30, 32 are disposed along the side of the lane 20 with one gutter on each side of lane 20 in a customary manner, i. e., adjacent to and in substantially abutting relationship with the lane. The gutters 30, 32 are adapted to receive any balls that are bowled toward one side of the lane and to direct any misdirected balls to the end of the alley. Also illustrated are capping members 34 which separate the adjacent alleys or lanes. The mechanism for bumper bowling is illustrated more clearly in FIGS. 2 and 3. As illustrated therein, a bumper bowling system is incorporated in the bowling alley 10 which includes two sides 21, 21' and a longitudinally extending lane 20 on an upper surface thereof. In a preferred embodiment of the invention, each of the gutters 30, 32 define first and second concave, longitudinally extending portions 40, 42. The first portion 40 defines an arc-shaped concave surface 43 which forms a part of the gutter 32 and, in the preferred embodiment, forms about one-third of the gutter when viewed in cross section. The portion 40 also includes a pair of downwardly extending projections 44, 46 which are preferably parallel to one another. The projections 44, 46 support the portion 40 on a suitable base such as a plurality of cross members 48. The first projection 44 is adjacent to and abuts side 21 and is constructed and arranged to slide upwardly therealong as will be described hereinafter. The projection 44 may also include a resilient bumper 44' recessed thereon for engaging a bowling ball which is directed toward the bumper. The second longitudinally extending portion 42 also defines an arc-shaped concave surface 45 which, in the preferred embodiment, forms the outer two-thirds of gullet 32. The portion 45 also includes a pair of downwardly extending parallel projections 47, 49. The projections 47, 49 are fixed to the cross member 48 in a customary manner with a first of the projections 47 adjacent to and perhaps abutting projection 36. The second projection 49 is adjacent to and abutting capping member 34 which separates a pair of alleys. For conventional bowling, the longitudinally extending portions 40 are positioned in the lower or retracted position shown in FIGS. 1 and 2. However, where it is desired to convert the Jane to bumper bowling as defined more clearly in the aforementioned patents of Conklin et al. and Chandler et al,, each of which is incorporated herein in its entirety by reference, the portion 40 is raised upwardly along an arc as illustrated in FIGS. 3 and 5. The portion 40 is moved upwardly by means of a crank arm 54 and a pair of swivel connecting elements 56 and 58 to the position shown by the broken lines in FIG. 2. The swivel connecting elements 56 and 58 are operatively connected to the bottom of portion 40 in a conventional manner such as a bracket 55 and to the cross member 48 by means of a bracket 57. Locking means, such as projection 60 and detect 61 or other suitable mechanism, ay also be provided for maintaining the bumper in an elevated position. In a preferred embodiment of the invention, the portion 40 is moved upwardly along a path that corresponds to the arc shown m FIGS. 3 and 5. This motion is in the az plane so that there is little or no lateral motion, i.e., along the y axis as shown schematically in FIG. 5. In the preferred embodiment of the invention, the gutters 30, 32 may be divided into three segments or more. 32 abc and 34 abc along the length of the alley for ease of manufacture, shipping and installation. However, in such cases, the mechanism for raising and lowering a portion of the gutter will be interconnected in a conventional manner so that a bumper may be raised along the length of the alley from one end of the alley. A second embodiment of the invention is shown in FIG. 1V wherein an entire gutter 32 including a pair of downwardly projecting elements 70, 72 is lifted upwardly along an arc in an xz plane by means of a pair of crank arm assemblies 60, 62. A single assembly of the type shown in FIGS. 2 and 3 and as described above could be used. In either case, the assemblies 60, 62 or single assembly would be constructed and arranged and operate in the same manner as described above. As shown in FIG. 1V, the gutter is lifted upwardly without tilting so that the top of the gutter, i.e., both sides thereof, remains in a common horizontal plane. Also, in moving the portion 40 along an arc in the xz plane, it may be desirable to bevel the forward edge thereof to avoid any binding during the elevating step. While the invention has been described in connection with one of its preferred embodiments, it should be understood that changes and modifications may be made without departing from the scope of the appended claims.

A bowling alley bumper system which can be used for conventional bowling and for bumper bowling is disclosed. The bowling alley bumper system includes a pair of gutters having longitudinally extending portions and extending and retracting means for moving those portions into an extended position which allows bowling balls to fall into and roll along one of the gutters. In one embodiment, the portion is moved upwardly or downwardly along an arc in an xz plane with little or no lateral movement.

This application claims the benefit of Provisional U.S. Patent Appl. Ser. Nos. 61/509,523, filed Jul. 19, 2012, and 61/599,033, filed Feb. 2, 2015. BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to methods and arrangements for distinguishing between target areas and non-target areas during a laser surgical procedure, by coating or otherwise providing the non-target areas with a phosphorescent material or phosphor. The target areas may be any tissue or object at which the laser is directed. The non-target areas to which the phosphors are applied may include, but are not limited to, any portion of a scope or laser delivery apparatus, including a laser sheath, buffer material of the fiber, endoscope working channel, and cardiac or urological stents, as well as tissues in the vicinity the target. The phosphors applied to or providing in the non-target areas include any materials that, when exposed to a particular wavelength, emit light at a different wavelength. In one embodiment, the phosphors may be rare-earth nanophosphors that up-convert IR wavelengths to visible or near visible wavelengths, and therefore provide a detectable indication of overheating in the area of the target. However, the invention is not limited to up-conversion of IR wavelengths, or to emissions in the visible or near visible wavelengths, but also may include materials that down-convert higher wavelengths to visible or near visible, and to phosphors that emit IR or UV rather than visible or near-visible radiation. The phosphors may also be used for monitoring purposes other than overheating detection. For example, phosphors may be included in the fiber itself, and in particular the cladding and/or buffer, to be used as an indicator of excess energy absorption in the cladding or buffer. Furthermore, multiple different types of phosphors may be provided in a particular application to carry out different monitoring functions. The phosphor emissions may be monitored in a variety ways, including automated wavelength or frequency detection, as well as observation of visible wavelengths by an operator or clinician. In addition, analysis techniques may include frequency domain (Fourier) analysis and other complex signal analyzing techniques. 2. Description of Related Art Copending U.S. patent application Ser. No. 13/127,911 (PCT Pub. WO 2010/053575) describes feedback systems described therein are used in connection with sacrificial elements or coatings that absorb selected wavelengths of radiation emitted during a surgical procedure, and that in response heat up or emits radiation in a way that can more easily and reliably be detected by the treatment site monitoring arrangement. The present invention is based on similar principles, but the phosphors of the present invention are not intended to be sacrificed, but rather are detected based solely on frequency conversion or fluorescence signature. Copending U.S. patent application Ser. No. 13/070,247 (U.S. Pub. 2011/0238048) is also of interest since it discloses distinguishing radiation emitted as a result of fiber breakdown from radiation reflective of a normal surgical procedure based on radiation event counts. The present application provides an alternative and more versatile way of distinguishing between events, although it can also be combined with the count procedure of the copending application. In addition to disclosure of various techniques and arrangements for distinguishing between target and non-target emissions at a treatment site, the inventor has proposed a variety of treatment-monitoring feedback systems that can detect the wavelength, amplitude, or timing of radiation that originate at the surgical site, including feedback systems capable of analyzing the frequency spectrum of emissions. Examples of feedback systems that can be used with the method and apparatus of the invention are described in copending U.S. patent application Ser. Nos. 11/714,785 (U.S. Pub. 2007/0167937), 12/073,922 (U.S. Pub. 2009-0149845), 13/070,247, and 13/127,911 (PCT Pub. WO 2010/053575), each of which is incorporated by reference herein. SUMMARY OF THE INVENTION A method for distinguishing between target areas and non-target areas during a laser surgical procedure involves coating or otherwise providing the non-target areas with a phosphorescent material or phosphor that emits radiation at wavelengths or frequencies distinguishable from those of the treatment radiation, and detecting emissions from the phosphor that are indicative of overheating, excess energy absorption, or other conditions to be monitored during the surgical procedure. The target areas may be any tissue or object at which the laser is directed. The non-target areas to which the phosphors are applied may include, but are not limited to, any portion of a scope or laser delivery apparatus, including a laser sheath, buffer material of the fiber, endoscope working channel, and cardiac or urological stents, as well as tissues in the vicinity the target. The invention includes the parts of the scope or laser delivery apparatus that have been coated or treated with phosphors, or that include phosphors within the material of the respective parts, as well as to the coatings and/or treatments by which the phosphors are applied at the treatment site. Those skilled in the art will appreciate that the invention relates not only to a method, but also to laser delivery devices, scopes, or other apparatus that have been painted or coated with a rare-earth phosphor of the type described herein, and in particular that can down convert up convert selected wavelengths, and/or that exhibit auto-fluorescence for an interval that is easily distinguishable from that of a non-painted or coated target. In addition, the invention relates to any sort of marker that has been painted, coated, or otherwise provided with rare-earth fluorescent nanophosphors of the type described herein. According to a preferred embodiment of the invention, the method involves painting the non-target area with a rare-earth phosphor that can up convert IR wavelengths to visible or near visible wavelengths, and that therefore provides a detectable indication of overheating in the area of the target. Alternatively, or in addition to the use or up converting rare-earth fluorescent nanophosphors, the invention can utilize rare-earth fluorescent nanophosphors that down-convert wavelengths to visible or near visible, and/or that exhibit auto-fluorescence for an interval that is easily distinguishable from that of a non-painted area. Furthermore, to distinguish non-target tissues where painting or coating is not a viable option, the phosphors may be applied to a marker that can be positioned in the area of the non-target tissues. Examples of phosphors suitable for use in the method of the invention are the rare-earth fluorescent nanophosphors described in the article SPIE Newsroom, DOI: 10.1117/2.2201009.0001 (Sep. 17, 2010), which up-convert from near-IR to visible wavelengths, incorporated by reference herein. Different phosphors may be used simultaneously to indicate the occurrence of different types of events that might require different responses on the part of the clinician. In addition to visual observation of emissions by a clinician, for example, by looking for characteristic colors of light emitted by the phosphors, the method and phosphor coated/treated parts of the invention may be used in connection with any automated feedback system capable of detecting the wavelength, amplitude, timing, or signature (pattern) of radiation that originate at the surgical site, and in particular that are capable of detecting wavelengths emitted by the phosphor. Examples of feedback systems that can be used with the method and apparatus of the invention include those described in the above-cited copending U.S. patent application Ser. Nos. 11/714,785 (U.S. Pub. 2007/0167937), 12/073,922 (U.S. Pub. 2009-0149845), 13/070,247, and 13/127,911 (PCT Pub. WO 2010/053575), each of which is incorporated by reference herein. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a flowchart illustrating a preferred method of distinguishing between target and non-target areas. FIG. 2 is a schematic diagram illustrating parts that may be coated or treated with phosphors according a preferred embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS As illustrated in FIG. 1 , the method of a preferred embodiment of the invention includes the step 100 of coating or otherwise providing non-target areas at a treatment site with a phosphor that emits radiation at wavelengths or frequencies distinguishable from those of the treatment radiation. This step may be accomplished by coating parts of the surgical instrument, introducer, or fiber with a material containing a phosphor, by including the phosphor in the material of the surgical instrument, introducer, or fiber, by coating non-target tissues at the treatment site with the phosphor-containing material, or by providing a phosphor-containing marker near the target. The phosphor may be a rare-earth nano-phosphor, or any other material that emits light at predetermined frequencies or wavelengths in response to stimulation by incident light or radiation within a characteristic frequency or wavelength range. For example, if the stimulation wavelengths are infrared wavelengths, then the emissions, which may be but are not limited to visible or near-visible wavelength emissions, can be used to provide an indication of temperature. If the emissions are visible wavelengths, then the color associated with the wavelengths can provide an easily discernible indication of overheating to a clinician viewing the treatment site through a scope. Alternatively, phosphors within the cladding or buffer of a fiber may emit light of any detectable wavelength in response to excess radiation capture by the cladding or buffer so as to provide a warning of problems with the fiber itself. Step 200 of the method illustrated in FIG. 1 is the detection step, which involves detection of emission from the phosphor that are indicative of overheating, excess energy absorption, or other conditions to be monitored at the treatment sited during a surgical procedure. As noted above, the invention may be used with feedback detection apparatus such as those described in copending U.S. patent application Ser. Nos. 11/714,785 (U.S. Pub. 2007/0167937), 12/073,922 (U.S. Pub. 2009-0149845), 13/070,247, and 13/127,911 (PCT Pub. WO 2010/053575), and may involve detection of emissions based not only on frequency or wavelength, but also on timing or pattern. For example, the “phosphor” materials may include materials that exhibit auto-fluorescence for specific intervals that are detectable from those of background or treatment radiation. In cases where the background or treatment radiation is not easily distinguishable, or where multiple different phosphor materials are employed to monitor different conditions at the treatment site, more complex analysis techniques, such as Fourier analysis, may be used to detect emissions from the phosphor material(s). Since the rare-earth fluorescent nanophosphors used by the present invention can emit light in visible wavelengths, however, light from the phosphors may advantageously also be detected by visual observation by a clinician. In particular, the phosphor may be selected to fluoresce with a particular color that is easily detectable by the observer, even against a bright background of glowing target tissues. For example, non-target laser delivery device breakdowns can be indicated by a red glow to indicate to the clinician that the laser needs to be paused or modulated. On the other hand, markers that fluoresce in a blue wavelength may be placed near adjacent non-target tissues to warn the clinician or operator that the non-target tissues are being affected, to assist the clinician in properly aiming the laser. FIG. 2 is a schematic representation of an arrangement for carrying out the method of the invention. Treatment radiation is provided by a laser 10 through a fiber 11 . Monitoring is optionally provided by monitor 13 , which may detect light carried from the treatment site to the monitor 13 by a scope, introducer, or fiber (including possibly the fiber used to carry the treatment radiation), or electrical signals from a sensor, detector, camera, or the like at the treatment site. Monitoring may also be carried out by the clinician viewing the treatment site using conventional apparatus, but with indication of overheating or other conditions at the treatment site being given by observable changes in the view of the treatment site, such as changes in color that result from phosphor emissions. Element 14 in FIG. 2 represents any part of a surgical instrument, introducer, scope, laser delivery device, sheath, fiber, or other apparatus, device, or part present at the treatment site and to which one or more phosphors have been applied by coating, painting, inclusion in the material of the part, or the like. Element 15 schematically represents the target tissue, while element 16 represents a coated or painted non-target tissue or a marker that has been painted, coated, or otherwise provided with a phosphor, such as a rare-earth fluorescent nano-phosphor, of the type described herein. Having thus described and illustrated preferred embodiments of the invention, it will be appreciated that the invention is not to be limited to the specific embodiments described and illustrated herein.

Methods and arrangements for distinguishing between target areas and non-target areas during a laser surgical procedure involve coating or otherwise providing the non-target areas with a phosphorescent material that emits radiation, upon stimulation when a predetermined condition occurs, that is distinguishable from the treatment radiation.

BACKGROUND OF THE INVENTION (1) Field of the Invention The invention pertains to disinfection apparatus for use with hemodialysis apparatus. (2) Description of the Prior Art One of the features of blood dialysis apparatuses--so-called hemodialysis devices--is a circulation system for dialysis fluid. This circulation system features a water supply and a dialyzer. The water supply and dialyzer are connected to one another by an initial fluid line. A second fluid line leads from the dialyzer to the discharge. The first and second fluid lines each feature a connector which connects the respective line to the dialyzer. While the dialysis fluid circulation system is being disinfected, a disinfecting apparatus is interposed into this circulation system, and the two fluid lines are connected in a bypassing manner by a shunt piece between their respective connectors. The disinfection of hemodialysis devices is an essential cleaning step between successive dialysis processes. The goal of this disinfection is the complete cleaning and sterilization of all surfaces and devices which come into contact with the dialysis fluid and/or its concentrates or thinning fluids. Inadequate disinfection of the dialysis fluid circulation system can lead to considerable damage to the health of the patient being treated. However, the only parts of the hemodialysis device which undergo disinfection are those which can be considered part of the dialysis fluid circulation system. The reason for this is that all parts of the blood circulation system are removed and replaced by new, sterile parts after each dialysis process. In a familiar method for cleaning hemodialysis devices, the dialysis concentrate is replaced by a disinfectant concentrate (typically from a 10-liter canister), which is pumped through the hemodialysis device. In this method, the two fluid lines (i.e., water supply line and dialysis fluid discharge line) are not shunted together. When disinfection has been completed, the disinfecting fluid remains inside the device. Before beginning the next dialysis process, the dialysis device is flushed with water. This process requires the use of a great quantity of the disinfectant. It accomplishes the cleaning of only that portion of the dialysis apparatus which is located downstream from the point at which the disinfectant is added. The applicant's hemodialysis devices A2008C-E are typical embodiments of these devices. Improved embodiments--as represented, for example, in DE 3 447 989 and DE 3 941 103--recirculate the disinfecting solution after interposing a shunt connection between the first and second fluid lines. For one thing, this results in the complete cleaning of the dialysis fluid circulation system. It also reduces the consumption of disinfectants. Liquid cleaning agents (e.g., formaldehyde, peracetic acid, sodium hypochlorite, or similar chemicals) are ordinarily used as disinfectants. These cleaning agents are aggressive, environmentally unsound, unhealthy, and even somewhat poisonous. It is especially necessary to exercise great caution when using mixtures of the above-mentioned cleaning agents, since an explosion or a release of elemental chlorine can occur. It has only recently been discovered that citric acid functions as a disinfectant at high temperatures. Concentrated citric acid is also aggressive and can cause dangerous reactions when mixed with other chemicals. Aside from the high cost of transporting the disinfectant (which consists mainly of water), it is necessary to exercise great caution when replacing the concentrates for the dialysis fluid and disinfectant. To this end, special precautions have been taken to prevent the different liquids from being misrouted, i.e, to prevent these concentrates from being accidentally exchanged with one another. Examples of such precautions include special provisions for connecting the different canisters to the hemodialysis device and separate controls for the fluid lines. There is therefore an urgent need for a disinfecting apparatus which reduces the danger of accidental exchange described above, while ensuring a safe, complete disinfection of the hemodialysis device. SUMMARY OF THE INVENTION This problem is solved by providing the disinfecting device with a container which features two adapters for the purpose of attachment to the first and second connectors. This container contains a predetermined dose of a disinfectant. The container of the disinfecting apparatus can take the form of an apparatus which is rigidly attached to the machine and features a stopper, or it can be a disposable or recyclable container which is externally refillable. In one advantageous embodiment of the invention, the adapters are designed in accordance with DIN (German Industrial Standard) 58 352. This prevents the connections from being accidentally exchanged and makes the adapters universally applicable. It is also advantageous to provide the container with a closable fill opening which is suitable for receiving a dose of the disinfectant when refilling. In one preferred embodiment of the invented apparatus, a filter is provided inside the disinfectant container, in the vicinity of the discharge adapter. The pores or grid openings of this filter are smaller than the grain size of the disinfectant powder. Portions of the disinfectant powder which have not yet dissolved are thus retained. An upwards flow through the container of the disinfecting apparatus and a tangential inflow of water into the container prove to be especially favorable to the distribution and dissolution (where applicable) of the disinfectant. When a liquid disinfectant is used, it is advantageous to provide a non-return valve in the refillable container, in the region of the discharge adapter. The non-return valve can be opened by the pressure of the onrushing water. It is located in a lower position during operation. In an especially preferred embodiment of this invention, a powdered disinfectant (e.g., crystalline or granulated citric acid) is used for disinfection. A special advantage of using solid disinfectants is that it prevents the accidental exchange of disinfecting fluid and dialysis fluid, which has occasionally occurred in the past. This makes the disinfection of hemodialysis devices considerably safer. The citric acid is provided in a suitable dose--for example, in a quantity of 5-30 grams for each liter of the volume to be disinfected. The container is designed to hold such a quantity. When the container is full, an unhindered flow can occur through the container. This ensures that the citric acid solution is recirculated within the hemodialysis device in a sufficiently high concentration. It also ensures that disinfection will occur safely and completely. In another embodiment of the invention, it is also possible for the closable container of the disinfection apparatus to be filled with a liquid cleaning agent (e.g., solutions of peracetic acid, formaldehyde, or sodium hypochlorite). The use of individual packages of concentrate solutions also offers the considerable advantage of allowing the refill packages to be unmistakably distinguished from the containers of dialysis fluid, so that accidental exchanges can be prevented more effectively than in the past. Another advantage of using cleaning agent concentrates is a reduction in the transport volume of the cleaning agent, which in turn results in cost savings. The dialysis fluid tubes are connected to the dialyzer during dialysis. After dialysis is concluded, the dialyzer is removed and the respective connectors of the first and second fluid lines are connected to the container of the disinfecting device. It is advantageous for a holder and sensor to be mounted on the hemodialysis device. The sensor allows the positioning of the container to be determined with certainty, so that the presence and appropriate arrangement of the disinfecting device can be monitored simply and with certainty at all times. In order to further ensure the certainty of monitoring the disinfecting device, one preferred embodiment of the invention provides additional sensors in the connectors which connect the refillable container of the disinfecting apparatus to the first and second fluid lines. These sensors make it possible to check for secure connections between these connectors and the container. The sensors do not allow the disinfecting operation to begin until this connection exists. In order to allow a clear distinction between a simple rinsing of the hemodialysis device and a complete disinfection process, the container of the disinfecting apparatus can be controlled by means of a bypass valve. This bypass valve can be either electrically controllable or mechanically operable and electrically readable. In one advantageous embodiment of this invention, the supply line, discharge line and/or dialysis fluid supply are connected by a recirculation line. The apparatus features a closing device for the purpose of creating the recirculation system. With the recirculation system closed in this manner, a complete cleaning of all parts and surfaces of the dialysis fluid circulation system is ensured. DESCRIPTION OF THE DRAWING A preferred embodiment of the invention is represented in FIGS. 1 and 2 below. FIG. 1 represents a diagram of a hemodialysis device during the disinfecting process, in a sectional view. FIG. 2 represents a section through a container of the disinfecting apparatus. DESCRIPTION OF THE PREFERRED EMBODIMENTS The hemodialysis device 10 represented in FIG. 1 features a water supply 11, which empties into a mixing container 14 (dialysis fluid supply) via a line 12, in which a valve 13 is inserted. The mixing container is in turn connected to a supply 16 of an electrolyte concentrate. An initial fluid line 18 exits the mixing container 14. The end of this initial fluid line protrudes from the hemodialysis device 10 and features an initial connector 20. This initial connector 20 is ordinarily connected to a dialyzer (not shown) during dialysis. A second fluid line 22 leads back into the hemodialysis device 10. This second fluid line features a second connector 24 on the end which is located outside the hemodialysis device 10. This second connector is connected to the discharge of the dialyzer (not shown) during dialysis. A pump 26 is interposed in the second line 22 inside the hemodialysis device 10. The other end of the second line 22 is ultimately connected with the discharge 28. This type of dialysis device represents the state of the art and is therefore not the object of this invention. The hemodialysis device 10 is represented in FIG. 1 as it functions during the disinfection phase. For this purpose, a disinfectant container 30 is provided between the two connectors 20 and 24. It is advantageous for this container to display a hollow cylindrical form. This disinfectant container 30 features a supply adapter 32 and 34 at each of its two ends. These two adapters 32 and 34 can be connected in a form-fitting manner to the two connectors 20 and 24. It is advantageous for these adapters to display a form identical to that of the adapters of the dialyzer (not shown), since the latter are subject to international standards of uniformity. In accordance with this embodiment, these adapters take the form of the connection specified by DIN (German Industrial Standard) 58 352. Connectors 20 and 24 are also designed in accordance with this standard. According to one preferred embodiment, at least one of the adapters 32 or 34--through which the fluid flows into the container 30--is arranged tangentially to the longitudinal axis of the hollow cylindrical container 30. This optimizes the flow of fluid into, and out of, the container 30. The disinfectant container 30 is filled with a disinfectant 36 which can display a granular (i.e., powdered) structure, as represented in FIG. 1. A grid-shaped cylindrical filter 38 is provided inside the disinfectant container 30, in the region of the discharge adapter 34. This filter is completely enclosed and displays an average mesh opening size which is smaller than the disinfectant particles. The purpose of this filter 38 is to retain undissolved disinfectant within the disinfectant container 30. In the embodiment represented in FIG. 2, a liquid disinfectant concentrate 36 is provided inside the disinfectant container 30. The container 30 represented in FIG. 2 is shown as positioned for use; in other words, the discharge adapter 34 is located on the bottom. In order to prevent the liquid disinfectant 36 from flowing out while the connections are being made, a non-return valve 40 is provided in the discharge adapter 34. This non-return valve can be opened by the pressure of the onrushing mixture of water and disinfectant. Before being used, the disinfectant container 30 features caps 42 and 44 at both of its connections 32 and 34. These caps close off the two connections 32 and 34 and can be opened when necessary. A fill opening 46 can also be provided in the container 30. This opening is closed off by a cover 48. A holder 50 for the disinfectant container 30 is mounted on the hemodialysis device 10. In the example represented here, this holder takes the form of two clamping jaws 50 which can be folded open. An initial sensor 52 is also mounted on the hemodialysis device 10 in the vicinity of this holder 50. This sensor is activated by the container 30 when the container is inserted into the holder 50. The sensor displays a predetermined positioning of the container 30. This sensor 52 is activated by the container 30, but not by the dialyzer, in the event that the dialyzer is inserted into the holder 50. This ensures that a container 30 is inserted and mounted on the dialysis device 10 in a predetermined position. Connectors 20 and 24 can also be equipped with contact sensors 54 and 56, which are connected to the hemodialysis device 10 via a connecting line, as shown symbolically in FIG. 1. With these contact sensors 54 and 56, it is possible to monitor the connection between the connectors 20 and 24 and the connections 32 and 34. In another embodiment, the second line 22 is connected to the mixing container 14 via a bypass line 58. Here the point of connection between the bypass line 58 and the line 22 features a valve arrangement 59. This valve arrangement provides the options of connecting the second line 22 to the discharge 28 or--in the recirculating operation--to the mixing container 14 via the bypass line 58. The supply line 16 and discharge line 22 are connected to the conventional bypass line 60, and a bypass valve 61 is provided at the point at which the two lines are connected. The sensors 52-56, valve arrangement 59, fresh water valve 13 and dialysis fluid pump 26 are connected to a control unit 74 via lines 62-72. The control unit is connected to an input unit 76 via line 78. As represented by the indicated arrows, the control unit 74 for performing disinfection can not be activated until the sensors 52-56 have sent the connection signal to the control unit 74 via lines 62-66 and the input unit 76 has been activated by the operator. The hemodialysis device 10 is operated in the following manner, in order to begin disinfection: The dialyzer is first detached from the connectors 20 and 24. The container 30, which has been filled with fresh disinfectant, is then connected to the two connectors 20 and 24 by its adapters 32 and 34. The contact sensors 54 and 56 ensure a form-fitting connection and notify the control unit 74 of this connection. The container 30 is then moved into a predetermined position in relation to the hemodialysis device 10. This is accomplished by inserting the container into the holder 50, where it activates the sensor 52. This sensor notifies the control unit 74--via the connecting line 62--of the appropriate predetermined position. The disinfection program can now be started by activating the input unit 76. In addition, the water supply 11 is activated by opening the valve 13, and the valve arrangement 59 is put into the recirculating operation. In accordance with an initial predetermined program sequence, which is stored in the control unit 74, the water is then led through the entire arrangement of lines 18, 22, 58, 14. This continues until the entire quantity of disinfectant is uniformly distributed within this system of lines. The disinfecting solution is then allowed to act upon the hemodialysis device 10 long enough to ensure that the entire dialysis system has been disinfected. A fresh water rinse is then performed by connecting the valve arrangement 59 alternately with the discharge 28 and the recirculation line 58 for rinsing. On the other hand, it is also possible to leave the device 10 filled with the disinfecting solution and rinse it shortly before using it again. Finally, it can also be advantageous to activate the bypass valve 61 via the connecting line 65 when it is intended that the water or disinfecting solution shall flow through the entire apparatus except the container 30. The hemodialysis device 10--which is now sterile and filled with fresh water--can then be used for another dialysis process. To this end, the disinfectant container 30 is detached from the connectors 20 and 24. These connectors are then connected to a sterile, unused dialyzer. In accordance with another method--the parameters of which are also stored in the control unit 74--the flow through the container occurs in an upwards direction when the container is positioned for operation. To this end, the pump 26 is switched by the control unit to pump in the opposite direction. The advantage of this type of method is that the powder 36 in the container 30 is swirled upwards, so that the discharge adapter 34 does not become clogged. On the other hand, this type of operation can also be achieved by mounting the end of the supply line 18 with the connector 20 at the bottom of the container 30 when positioned for use, while the discharge line 22 is attached at the top of the container 30. In this case, it is not necessary to reverse the output direction of the pump 16. When the flow occurs upwards within the container 30, it is also advantageous to arrange a filter 39 at the upper adapter 32. (This filter may be similar to the other filter 38.) As a result, the discharge of undissolved powder is prevented. For example, if solid citric acid granulate is used for disinfection, between 10 and 60 grams should be sufficient to fill the container 30 while achieving a disinfectant concentration of 0.5-3.0%. (This number of grams corresponds to a required volume of less than 100 milliliters. It also assumes that the filling volume of the hemodialysis device is 2 liters, and that the density of the granulated citric acid is approximately 1.) This amount of disinfectant can be put into the empty container 30 through the fill opening 46. The container can then again be used for disinfection. In order to ensure that the container is filled with the required amount of disinfectant, the container 30 can feature markings 80 on its outside. These markings can be used to determine the correct fill level and the quantity of disinfectant which has actually been added, provided that a transparent plastic material (e.g., polycarbonate) is used.

A hemodialysis device (10) which features an improved disinfection apparatus. Before disinfection begins, a container (30) of disinfectant (36) is interposed into the dialysis fluid circulation system in place of the dialyzer. The dialysis fluid circulation system is shunted, and the disinfecting solution which is present in this closed circulation system is flushed out of the container (30) and through the entire path of the dialysis fluid, in order to achieve a complete cleaning of the hemodialysis device (10). It is possible to use solid, soluble disinfectant (36) as well as liquid disinfectant.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a divisional of application Ser. No. 10/609,744 filed on Jun. 30, 2003, now U.S. Pat. No. 7,654,986, which claims priority under 35 U.S.C. 119 of Danish application no. PA 2002 01169 filed Aug. 1, 2002, and U.S. provisional application No. 60/394,083 filed Jul. 3, 2002, the contents of which are fully incorporated herein by reference. THE TECHNICAL FIELD OF THE INVENTION The present invention relates generally to injection devices and, in particular, provides methods and systems for mounting a needle to an injection device or to an ampoule that my be mounted in the injection device. DESCRIPTION OF RELATED ART Injection devices, also referred to as dosers, have greatly improved the lives of patients who must self-adminster drugs and biological agents. Dosers may take many forms, including simple disposable devices that are little more than an ampoule with an injection means or they may be highly sophisticated instruments with numerous functions. Regardless of their form, they have proven to be great aids in assisting patients to self-adminster injectable drugs and biological agents. They also greatly assist care givers in administering injectable medicines to those incapable of performing self-injections. In particular, pen-style injection devices, have proven to be an accurate, convenient, and often discrete, way to administer drugs and biological agents, such as insulin. Modern devices have become more sophisticated and often include diverse and robust functions, such as memories for remembering time and amount of last dose, as well as, in the case of insulin devices, blood glucose monitors. While pen-style dosers are typically cylindrically shaped with needles protruding from the most distal portion of one end of the device, some of the more modern and/or sophisticated dosers have other shapes with the needle no longer protruding from the most distal part of an end of the device. (See e.g., Innovo® and InnoLet® from Novo Nordisk A/S Bagsvaerd Denmark). Typically, injection devices use a pre-filled cartridge containing the medication of interest. The cartridge may be an integral part of the doser or it may comprise an ampoule having a membrane at one. See U.S. Pat. No. 6,312,413 to Jensen et. al, which is hereby incorporated by reference. Often the end of the ampoule having the membrane is fitted with a needle mount. The needle mount usually comprises a threaded mounting surface to allow a needle assembly, such as a needle and hub assembly, to be screwed on. The needle mount may be an integral part of the ampoule or may be a separate adapter top (see U.S. Pat. Nos. 5,693,027 and 6,126,646, which are hereby incorporated by reference) that is mounted to the ampoule. Of course, some dosers have needle mounts that are integral parts of the doser. In the typical injection device where the needle mount is not part of the doser, the end of the ampoule having the needle mount protrudes from the injection device. Where the needle mount is part of the doser, the needle mount is usually disposed on an outer end of the doser. In either embodiment, the needle hub is then screwed onto the needle mount. One disadvantage of the prior art needle mounting systems is that they require the patient to screw the needle hub onto the end of the ampoule, or the doser, by turning the needle relative to the device several times. For patients with dexterity problems, this is inconvenient. Moreover, it is often desirable to store needles for the injection devices in a magazine. Often many newer generation injection devices are not cylindrical and in many new devices, other parts of the device extend past the needle mount making it impossible to mount the needle on the injection device without first removing it from the magazine. SUMMARY OF THE INVENTION The present invention provides systems and methods for mounting needle assemblies to injection devices and/or ampoules. In some, but not necessarily all embodiments, the system and method of the present invention allows a needle and hub assembly to be mounted on an ampoule and/or injection device without having to rotate completely the needle hub assembly relative to the injection device. In one embodiment of the present invention, a needle assembly is comprised of a needle mounted in a hub. The needle assembly also includes a means for mounting the hub to a needle mount with only a partial rotation of the needle hub relative to the mount. In an other embodiment of the present invention, a needle mount for mounting the needle assembly is comprised of an outer wall and a mounting means for affixing the needle assembly to a top end of the outer wall. In some embodiments, the means provides for completely securing the needle assembly to the needle mount with only a partial rotation of the needle mount. In some embodiments, the needle mount includes a means for aligning the needle assembly on the mounting means. The needle mount and needle assemblies of the present invention, when combined, make up a needle mounting system. The system, or its components, may also include a means for tactilely or audibly determining when the needle assembly is securely mounted on the needle mount. At least one embodiment of the present invention includes a needle assembly that is comprised of a needle mounted to a hub having an interior wall. In this embodiment, a plurality of protrusions extends radially inward from the wall of the hub. Typically, the hub wall is cylindrical. A needle mount for use with the present invention, may in at least one embodiment, include a structure having a cylindrical outer wall. A plurality of grooves is disposed on the outer wall. The grooves begin at the top of the wall and contain at least two portions: a first portion that defines a passageway that is substantially parallel to the cylindrical axis of the outer wall, and a second portion that is oriented at an angle to the first portion. Of course, the present invention may be embodied in structures wherein the grooves are disposed inside the hub of the needle mount and the protrusions are disposed on an outer surface of the needle mount. In at least one embodiment of the present invention, the needle assembly is completely mounted on an injection device with only a partial rotation of the needle assembly relative to the injection device. (Those skilled in the art will recognize that rotation of the needle assembly relative to the injection device may be accomplished by holding the device stationary and rotating the needle assembly or by holding the needle assembly stationary and rotating the device or by a combination of these steps). In some embodiments, the needle is mounted on an ampoule that is mounted in the injection device. The present invention therefore provides a method for mounting needles to injection devices. The method may be useful in mounting needles stored in magazines and is particularly useful for injection devices that have a portion that extends past the needle mount. In one embodiment, the injection device is partially inserted into a magazine holding needle assemblies. The injection device is rotated relative to the magazine by less than a full revolution and is then removed with the needle assembly attached thereto. In some embodiments no or minimal rotation is required. In other embodiments of the present invention, the needle assembly may include a cylindrical hub that has a needle mounted thereon. The hub may have an internal cylindrical element with an outside cylindrical wall that faces the hub's inside cylindrical wall. A plurality of protrusions may extend radially outward from the internal cylindrical element. A corresponding needle mount may be used. The needle mount, in one embodiment, may include a plurality of locking elements arranged on an interior cylindrical surface (e.g., a wall) of the needle mount to form first passageways that are substantially parallel to the cylindrical axis of the needle hub. In some embodiments, the locking elements are disposed on a ring that is part of the interior surface or that is attached to, or part of, an inside wall of the needle mount. Further the protrusions could be sized to fit between threads of a standard ampoule adapter top. The protrusions arranged on the inner hub wall and aligned between the threads of a standard adapter top would allow the needle assembly to be screwed onto the adapter top in a traditional manner. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a three-dimensional view of a needle hub and needle mount according to one embodiment of the present invention. FIG. 2 is a cut-away view of the needle mount and needle hub shown in FIG. 1 . FIG. 3 is a three-dimensional view of a needle assembly and needle mount according to a second embodiment of the present invention. FIG. 4 illustrates the embodiment of FIG. 3 when viewed from below. FIG. 5 is a cut-way view of the needle assembly of FIGS. 3-4 . FIG. 6 is an enlarged view of the needle assembly mounting means of the embodiment shown in FIGS. 3-5 . FIG. 7 is a cut through view of the needle mount and needle hub illustrating one embodiment of the present invention for tacitly determining whether the needle hub is securely mounted on the needle mount. FIG. 8 is a side view of a magazine for storing needles that may be used in practicing the method steps of the present invention. FIG. 9 is a top view of the magazine shown in FIG. 8 . DETAILED DESCRIPTION OF THE INVENTION The present invention provides for systems and methods for attaching needle hub assemblies to ampoules and injection devices. Typically, a needle hub assembly comprises a needle 510 mounted to a hub 500 (see e.g. FIG. 3 ). As is shown in FIG. 1 , a needle hub 10 may be generally cylindrically shaped and have an interior wall surface 20 . In one embodiment of the present invention, a plurality of protrusions 30 extends radially inward from the interior surface 20 . A needle mount 100 is designed to accept the needle hub 10 . (See e.g. FIG. 1 ). As is shown in FIGS. 1 and 2 , the needle mount 100 may be generally cylindrically shaped and have an exterior wall surface 110 . A plurality of grooves or slots 120 are disposed in the exterior surface 110 . The grooves 120 have a first end 122 and a second end 125 . The grooves 120 have a first portion 130 that defines a passageway that is generally parallel to the cylindrical axis 1000 of the needle mount 100 . While the first portion of the groove 130 is shown in the drawings as having a rectangular portion, the exact shape of the groove is not critical so long as it allows the protrusions 30 on the needle hub to move in a direction parallel to the cylindrical axis 1000 . Thus, while the groove may have walls that are not necessarily parallel to the cylindrical axis 1000 , the groove may still be said to be parallel to the cylindrical axis if it allows the protrusions 30 to move in a direction parallel to the cylindrical axis. The first portion of the grooves 130 may have width that is wider than the remainder of the first portion or the remainder of the groove 130 . In embodiments where the groove has walls that are not parallel to the cylindrical axis 1000 , the width of the first portion of the groove 130 may be the average width for the first portion of the groove 130 . The first portion 130 may have an entrance 135 that has a width dimension that is greater than the average width of the first portion or is wider than the average width of the entire groove 120 . The entrance 135 may act as an alignment means for aligning the needle hub so that the protrusions will enter the groove 120 . In most embodiments, but not all, the entrance width is wider than any other point in the groove 120 . Typically the width of the groove narrows as the groove is traversed away from the entrance 135 . As is shown, the groove may reach a constant width at some distance from the opening. In some embodiments the width of the first portion 130 is widest at the entrance 135 and continues to narrow over the length of the first portion 130 . The grooves also have a second portion 150 that is either perpendicular to the cylindrical axis 1000 , or lies at angle to the first portion 130 . In some embodiments of the present invention the second portion 150 may be comprised of only one surface that is generally perpendicular to the cylindrical axis of the needle mount. Thus, the second portion of the groove 150 need not be a slot having two sides, but needs only one side to prevent protrusions on the needle hub from moving toward the outer end of the needle mount. As shown in FIG. 1 , the grooves 120 may also have a third portion 160 that is oriented at an angle to the first portion 130 and the second portion 150 . In some embodiments of the present invention a means for tacitly determining whether the needle assembly is securely fixed to the hub is provided. This may be accomplished in numerous different ways, including providing a small projection(s) 439 at the side or in the bottom of the second portion of the grooves 120 . (See e.g. FIG. 7 ). The protrusions 30 have to overcome the projections 439 before the needle is fixed. The deformation of the projections may cause a tacitly feel or a sound, such as a clicking sound. Thus, in some embodiments of the present invention, the needle mounting system can be designed so that the needle hub and the needle mount generate a clicking sound when the needle is securely placed on the mount. When the hub is to be remounted from injection device the oblique tactile protrusions can be more sharp at their ends, so that hub is better fixed during injection and handling etc. This also makes it possible for the patient to keep the needle for more injection. One advantage of the present invention is that the needle mount, may be equipped with standard threads 200 on its exterior surface. (See FIG. 1 ). The grooves 120 may be cut into the standard threads 200 . This allows the needle mount 100 to accept not only needle hubs of the present invention, but also standard, threaded needle-hub assemblies. While FIG. 1 shows the grooves on the needle mount and the protrusions on the needle hub, the present invention may be configured with the grooves located on the interior surface of the needle hub and the protrusions extending outward from the exterior wall of the needle mount. In some, embodiments it may be advantageous to size and shape the protrusions so that they fit between standard threads used with existing needle hubs. The protrusions may then be arranged on the exterior wall of the needle mount to allow not only needle hub assemblies having grooves in their interior wall to be attached, but also standard, threaded needle hubs. The present invention may take numerous other forms, including—but not limited to—that shown in FIGS. 3-6 . As is shown in FIGS. 3-6 . the needle hub assembly 500 has a needle 510 mounted thereto. The needle hub 550 may be generally cylindrically shaped and has an interior wall surface 600 and a closed top end 610 . The closed top end 610 has an inside surface 620 . A cylindrical member 650 protrudes from the inside surface 620 and has an outer surface 660 . See FIG. 5 . Protrusions 670 extend radially outward from the outer surface 660 . The protrusions may take various forms and shapes, including the triangular prism shape shown in the drawings. The needle hub assembly shown in FIGS. 3-5 may be used with a modified needle mount, 700 . As is shown in FIGS. 3-6 , the needle mount 700 may be generally cylindrically shaped and have a top end, an interior surface, an exterior surface, and a plurality of locking elements (which may be additional protrusions) extending from the interior surface inward. The locking elements may be arranged to form passageways for the protrusions 500 on the needle mount, thereby forming a plurality of grooves for accepting the protrusions from the needle hub assembly 500 . As is shown in FIG. 6 , the grooves may have a first portion 561 that defines a passageway that is generally parallel to the cylindrical axis of the needle mount, a second portion 571 that is perpendicular to the cylindrical axis and a third portion 588 that connects the second 571 and first portions 561 . The first portion 561 may be widest at its opening and thus act as an alignment mechanism for the protrusions on the needle hub. The needle mount may have a mounting surface 581 on which a portion of the needle hub rests when the needle hub is mounted on the needle mount. The mounting surface may be a top edge of the top end of needle mount, or it may be the exterior wall surface 599 of the needle mount or both. The embodiment shown in FIGS. 2-4 also advantageously allows the outer surface of the needle mount to have threads so that standard prior-art needle hubs may be used with the improved needle mount of the present invention. The present invention enables various methods for attaching a needle-hub assembly to an ampoule or injection device. For example, in one embodiment of the present invention, a needle mount is inserted into a needle hub, the needle hub is rotate relative to the needle mount less than one revolution—typically between 5 and 30 to 60 degrees. In some embodiments, a clicking noise or vibration or other tactile feedback will be provided to indicate that the needle is securely mounted to the hub. In some embodiments little rotation is necessary. In some embodiments, it is possible that no rotation is needed. The surface of the locking element 777 could simply force the hub to rotate upon insertion of the mount into the interior of the hub 500 . In other embodiments, more rotation may be required. Because the methods of mounting a needle hub to a needle mount do not require that the hub be rotated a full revolution relative to the mount (i.e. either the hub is rotated and the mount is held stationary or the mount is rotated and the hub is held stationary, or both are turned in opposite direction), the present invention enables and provides for methods of mounting needle-hub assemblies stored in magazines, similar to that shown in FIGS. 8 and 9 , to injection devices where their shape would not allow the device to be rotated relative to the magazine by a full revolution. In one embodiment of the present invention, a portion of an injection device 3000 , usually the portion containing a needle mount 3010 , is inserted into a needle magazine 3050 . The device 3000 , without being rotated a full revolution is then removed with a needle fully attached to it. In some embodiments audible or tactile feedback is provided to indicate that the need is securely mounted to the device. In some embodiments, the portion of the device that is inserted into the magazine may be an end portion of an ampoule that extends from the device. Some methods of practicing the present invention may be performed using the needles are stored in a magazine having a flush surface 3070 and the needle and hub assemblies 3080 are located below the surface 3070 , usually—but not necessarily—in recessed cavities 3090 (see FIG. 9 ). The foregoing is a brief description of some exemplary embodiments of the present invention and is intended to be illustrative and not exhaustive of the present invention. Those of skill in the art will recognize the nature of language makes it impossible to capture the essence of all aspects of the present invention and unimportant and insubstantial substitutes for various elements are intended to be included within the scope of the invention as defined by the following claims.

A needle mounting system and methods for mounting a needle assembly on a needle mount are disclosed. The needle mounting system includes a needle hub having protrusions extending radially inward. A needle mount has a plurality of slots to receive the protrusions. The slots have a first portion that defines a passageway substantially parallel to a longitudinal axis of the needle mount and a second portion substantially perpendicular to the axis. The needle hub and mount provide a method wherein a needle assembly may be mounted on an injection device without completely rotating the needle hub relative to the needle mount.

BACKGROUND OF THE INVENTION [0001] This invention relates to vitamin D compounds, and more particularly to pharmaceutical uses for 2-methylene-19-nor-20(S)-1α,25-dihydroxyvitamin D 3 . [0002] The natural hormone, 1α,25-dihydroxyvitamin D 3 and its analog in ergocalciferol series, i.e. 1α,25-dihydroxyvitamin D 2 are known to be highly potent regulators of calcium homeostasis in animals and humans, and more recently their activity in cellular differentiation has been established, Ostrem et al., Proc. Natl. Acad. Sci. USA, 84, 2610 (1987). Many structural analogs of these metabolites have been prepared and tested, including 1α-hydroxyvitamin D 3 , 1α-hydroxyvitamin D 2 , various side chain homologated vitamins and fluorinated analogs. Some of these compounds exhibit an interesting separation of activities in cell differentiation and calcium regulation. This difference in activity may be useful in the treatment of a variety of diseases as renal osteodystrophy, vitamin D-resistant rickets, osteoporosis, psoriasis, and certain malignancies. [0003] Recently, a relatively new class of vitamin D analogs has been discovered, i.e. the so called 19-nor-vitamin D compounds, which are characterized by the replacement of the A-ring exocyclic methylene group (carbon 19), typical of the vitamin D system, by two hydrogen atoms. Biological testing of such 19-nor-analogs (e.g., 1α,25-dihydroxy-19-nor-vitamin D 3 ) revealed a selective activity profile with high potency in inducing cellular differentiation, and very low calcium mobilizing activity. Thus, these compounds are potentially useful as therapeutic agents for the treatment of malignancies, or the treatment of various skin disorders. Two different methods of synthesis of such 19-nor-vitamin D analogs have been described (Perlman et al., Tetrahedron Lett. 31, 1823 (1990); Perlman et al., Tetrahedron Lett. 32, 7663 (1991), and DeLuca et al., U.S. Pat. No. 5,086,191). [0004] In U.S. Pat. No.4,666,634, 2β-hydroxy and alkoxy (e.g., ED-71) analogs of 1α,25-dihydroxyvitamin D 3 have been described and examined by Chugai group as potential drugs for osteoporosis and as antitumor agents. See also Okano et al., Biochem. Biophys. Res. Commun. 163, 1444 (1989). Other 2-substituted (with hydroxyalkyl, e.g., ED-120, and fluoroalkyl groups) A-ring analogs of 1α,25-dihydroxyvitamin D 3 have also been prepared and tested (Miyamoto et al., Chem. Pharm. Bull. 41, 1111 (1993); Nishii et al., Osteoporosis Int. Suppl. 1, 190 (1993); Posner et al., J. Org. Chem. 59, 7855 (1994), and J. Org. Chem. 60, 4617 (1995)). [0005] Recently, 2-substituted analogs of 1α,25-dihydroxy-19-nor-vitamin D 3 have also been synthesized, i.e. compounds substituted at 2-position with hydroxy or alkoxy groups (DeLuca et al., U.S. Pat. No. 5,536,713), which exhibit interesting and selective activity profiles. All these studies indicate that binding sites in vitamin D receptors can accommodate different substituents at C-2 in the synthesized vitamin D analogs. [0006] In a continuing effort to explore the 19-nor class of pharmacologically important vitamin D compounds, an analog which is characterized by the presence of a methylene substituent at the carbon 2 (C-2) has been synthesized and tested. Of particular interest is the analog which is characterized by the unnatural configuration of the methyl group at carbon 20 (C-20), i.e. 2-methylene-19-nor-20(S)-1α,25-dihydroxyvitamin D 3 . This vitamin D analog seemed an interesting target because the relatively small methylene group at C-2 should not interfere with the vitamin D receptor. Moreover, molecular mechanics studies performed on the model 1α-hydroxy-2-methylene-19-nor-vitamins indicate that such molecular modification does not change substantially the conformation of the cyclohexanediol ring A. However, introduction of the 2-methylene group into 19-nor-vitamin D carbon skeleton changes the character of its 1α- and 3β-A-ring hydroxyls. Both hydroxyls are allylic to the exocyclic methylene group similar to the 1α-hydroxyl group (crucial for biological activity) in the molecule of the natural hormone, 1α,25-(OH) 2 D 3 . [0007] 2-methylene-19-nor-20(S)-1α,25-dihydroxyvitamin D 3 is known, and this compound exhibits a desired, and highly advantageous, pattern of biological activity which has been reported in DeLuca et al U.S. Pat. No. 5,843,928. This compound is characterized by intestinal calcium transport activity, similar to that of 1α,25-dihydroxyvitamin D 3 , but exhibiting very high activity, as compared to 1α,25-dihydroxyvitamin D 3 , in its ability to mobilize calcium from bone. Hence, this compound is highly specific in its calcemic activity. Its preferential activity on mobilizing calcium from bone allows the in vivo administration of this compound for the treatment of metabolic bone diseases where bone loss is a major concern. Because of its preferential activity on bone, this compound would be a preferred therapeutic agent for the treatment of diseases where bone formation is desired, such as osteoporosis, especially low bone turnover osteoporosis, steroid induced osteoporosis, senile osteoporosis or postmenopausal osteoporosis, as well as osteomalacia and renal osteodystrophy. SUMMARY OF THE INVENTION [0008] The present invention is directed toward various pharmaceutical uses for 2-methylene-19-nor-20(S)-1α,25-dihydroxyvitamin D 3 . (See formula I and hereinafter referred to as “2-MD”) In particular, the present invention demonstrates that administration of 2-MD will substantially increase the life expectancy of human beings, especially elderly human beings. More specifically, 2-MD increases the survival of females lacking estrogen (e.g. post-menopausal females), and reduces mortality resulting from malignant tumors in human beings (both male and female) by inhibiting tumorogenesis in the treatment of a cancer such as skin cancer, lung cancer, leukemia, colon cancer, breast cancer or prostate cancer. [0009] Structurally this 19-nor analog is characterized by the general formula I shown below: [0010] The solid wedge-shaped line to the methyl substituent at C-20 indicates that carbon 20 has the S configuration. The compound may be present in a composition in an amount from about 0.1 μg/gm to about 50 μg/gm of the composition, and may be administered in dosages of from about 0.1 μg/day to about 100 μg/day. The treatment may be transdermal, oral or parenteral. [0011] The above compound is characterized by high cell differentiation activity. Thus, this compound also provides a therapeutic agent for the treatment of malignancies, especially as an anti-tumor agent to inhibit tumorogenesis in persons afflicted with skin cancer, lung cancer, leukemia, colon cancer, breast cancer and prostate cancer. DETAILED DESCRIPTION OF THE INVENTION [0012] 2-methylene-19-nor-20(S)-1α,25-dihydroxyvitamin D 3 (referred to herein as 2-MD) was synthesized and tested. Structurally, this 19-nor analog is characterized by the general formula I previously illustrated herein. [0013] The preparation of 2-methylene-19-nor-20(S)-1α,25-dihydroxyvitamin D 3 having the basic structure I can be accomplished by a common general method, i.e. the condensation of a bicyclic Windaus-Grundmann type ketone II with the allylic phosphine oxide III to the corresponding 2-methylene-19-nor-vitamin D analog IV followed by deprotection at C-1 and C-3 in the latter compound: [0014] In the structures II, III, and IV groups Y 1 and Y 2 are hydroxy-protecting groups, it being also understood that any functionalities that might be sensitive, or that interfere with the condensation reaction, be suitably protected as is well-known in the art. The process shown above represents an application of the convergent synthesis concept, which has been applied effectively for the preparation of vitamin D compounds [e.g. Lythgoe et al., J. Chem. Soc. Perkin Trans. I, 590 (1978); Lythgoe, Chem. Soc. Rev. 9, 449 (1983); Toh et al., J. Org. Chem. 48, 1414 (1983); Baggiolini et al., J. Org. Chem. 51, 3098 (1986); Sardina et al., J. Org. Chem. 51, 1264 (1986); J. Org. Chem. 51, 1269 (1986); DeLuca et al., U.S. Pat. No. 5,086,191; DeLuca et al., U.S. Pat. No. 5,536,713]. [0015] Hydrindanones of the general structure II are known, or can be prepared by known methods. [0016] For the preparation of the required phosphine oxides of general structure III, a new synthetic route has been developed starting from a methyl quinicate derivative which is easily obtained from commercial (1R,3R,4S,5R)-(−)-quinic acid as described by Perlman et al., Tetrahedron Lett. 32, 7663 (1991) and DeLuca et al., U.S. Pat. No. 5,086,191. [0017] The overall process of the synthesis of compound I is illustrated and described more completely in U.S. Pat. No. 5,843,928 issued Dec. 1, 1998 and entitled “2-Alkylidene-19-Nor-Vitamin D Compounds” the specification of which is specifically incorporated herein by reference. The biological activity of 2-MD is reported in U.S. patent application Ser. No. 09/616,164, filed Jul. 14, 2000, the specification of which is also specifically incorporated herein by reference. EXAMPLE 1 [0018] This example demonstrates that in female rats that have undergone ovariectomy, their survival is significantly increased if they are given 2-methylene-19-nor-(20S)-1,25-(OH) 2 D 3 each day at 5-7 ng/kg/body weight orally. Thus, the experiment was carried out as follows: [0019] 48 retired female breeder rats of 12 months of age were obtained from the Harlan Sprague-Dawley Company. Upon arrival, the animals were ovariectomized or sham-operated. These animals were housed in individual hanging wire cages and provided water ad libitum. Food consumption was restricted to 19-21 g/day. Animals were maintained on a purified diet described by Suda et al (J. Nutr. 1970) which contained 0.47% calcium and 0.3% phosphorus. In addition, these animals received supplements of vitamin A, E, D, and K as described in the Suda paper. One half of the animals received each day 0.1 ml of Wesson Oil while the remaining one-half of the animals received orally the 0.1 ml of Wesson Oil containing 5 or 7 ng/2-MD/kg body weight. The animals were monitored weekly for body weight, general health and survival. These animals were followed for 7.5 months. During the course of this period, 4 of the 24 animals receiving the purified diet without supplementation failed to survive largely due to the development of mammary tumors. On the other hand, all animals receiving 2-MD survived the entire period and were in good health. [0020] These results demonstrate that 2-MD increases the survival rate to 100% in the aged, ovariectomized female rats. The mechanism appears to be inhibition of tumorogenesis inasmuch as at least 3 of the controls who failed to survive had developed tumors while the fourth died of unknown causes. The tabular data in Table 1 demonstrate the survival data and also provide the average body weight initially and at 7 ½ months. TABLE 1 Survival and Body Weight in Aged Female Rats Body Weight Survival Ratio g Treatment #premature deaths/total # animals Initial Final Vehicle 4/24 343 ± 6 367± 10 2-MD 0/24 361 ± 8 382 ± 10 [0021] For treatment purposes, the compound of this invention defined by formula I may be formulated for pharmaceutical applications as a solution in innocuous solvents, or as an emulsion, suspension or dispersion in suitable solvents or carriers, or as pills, tablets or capsules, together with solid carriers, according to conventional methods known in the art. Any such formulations may also contain other pharmaceutically-acceptable and non-toxic excipients such as stabilizers, anti-oxidants, binders, coloring agents or emulsifying or taste-modifying agents. [0022] The compound may be administered orally, topically, parenterally or transdermally. The compound is advantageously administered by injection or by intravenous infusion of suitable sterile solutions, or in the form of liquid or solid doses via the alimentary canal, or in the form of creams, ointments, patches, or similar vehicles suitable for transdermal applications. Doses of from 0.1 μg to 100 μg per day of the compounds are appropriate for treatment purposes, such doses being adjusted according to the disease to be treated, its severity and the response of the subject as is well understood in the art. Since the compound exhibits specificity of action, each may be suitably administered alone, or together with graded doses of another active vitamin D compound—e.g. 1α-hydroxyvitamin D 2 or D 3 , or 1α,25-dihydroxyvitamin D 3 —in situations where different degrees of bone mineral mobilization and calcium transport stimulation is found to be advantageous. [0023] Compositions for use in the above-mentioned treatment of malignancies comprise an effective amount of the 2-methylene-20(S)-19-nor-vitamin D compound as defined by the above formula I as the active ingredient, and a suitable carrier. An effective amount of such compound for use in accordance with this invention is from about 0.01 μg to about 50 μg per gm of composition, and may be administered topically, transdermally, orally or parenterally in dosages of from about 0.1 μg/day to about 100 μg/day. [0024] The compound may be formulated as creams, lotions, ointments, topical patches, pills, capsules or tablets, or in liquid form as solutions, emulsions, dispersions, or suspensions in pharmaceutically innocuous and acceptable solvent or oils, and such preparations may contain in addition other pharmaceutically innocuous or beneficial components, such as stabilizers, antioxidants, emulsifiers, coloring agents, binders or taste-modifying agents. [0025] The compound is advantageously administered in amounts sufficient to effect the differentiation of promyelocytes to normal macrophages. Dosages as described above are suitable, it being understood that the amounts given are to be adjusted in accordance with the severity of the disease, and the condition and response of the subject as is well understood in the art. [0026] The formulations of the present invention comprise an active ingredient in association with a pharmaceutically acceptable carrier therefore and optionally other therapeutic ingredients. The carrier must be “acceptable” in the sense of being compatible with the other ingredients of the formulations and not deleterious to the recipient thereof. [0027] Formulations of the present invention suitable for oral administration may be in the form of discrete units as capsules, sachets, tablets or lozenges, each containing a predetermined amount of the active ingredient; in the form of a powder or granules; in the form of a solution or a suspension in an aqueous liquid or non-aqueous liquid; or in the form of an oil-in-water emulsion or a water-in-oil emulsion. [0028] Formulations for rectal administration may be in the form of a suppository incorporating the active ingredient and carrier such as cocoa butter, or in the form of an enema. [0029] Formulations suitable for parenteral administration conveniently comprise a sterile oily or aqueous preparation of the active ingredient which is preferably isotonic with the blood of the recipient. [0030] Formulations suitable for topical administration include liquid or semi-liquid preparations such as liniments, lotions, applicants, oil-in-water or water-in-oil emulsions such as creams, ointments or pastes; or solutions or suspensions such as drops; or as sprays. [0031] For asthma treatment, inhalation of powder, self-propelling or spray formulations, dispensed with a spray can, a nebulizer or an atomizer can be used. The formulations, when dispensed, preferably have a particle size in the range of 10 to 100μ. [0032] The formulations may conveniently be presented in dosage unit form and may be prepared by any of the methods well known in the art of pharmacy. By the term “dosage unit” is meant a unitary, i.e. a single dose which is capable of being administered to a patient as a physically and chemically stable unit dose comprising either the active ingredient as such or a mixture of it with solid or liquid pharmaceutical diluents or carriers.

This invention provides pharmaceutical uses for 2-methylene-19-nor-20(S)-1α,25-dihydroxyvitamin D 3 . Administration of this compound increases the life expectancy of human beings, especially elderly human beings. In particular, it increases the survival rate of females lacking estrogen, especially post-menopausal females, and reduces mortality resulting from spontaneous development of malignant tumors in both males and females.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present invention claims priority to U.S. Provisional Application No. 62/352,497, filed Jun. 20, 2016, which is hereby incorporated in its entirety including all tables, figures, and claims FIELD OF THE INVENTION [0002] The invention pertains to the field of autoimmunity, more specifically, the invention pertains to the use of utilization of Noble gases to treated rheumatoid arthritis, more specifically the invention pertains to the use of gaseous compositions, in some embodiments, xenon-gas containing composition to reduce pain and inflammatory/autoimmunity processes subside. BACKGROUND [0003] Autoimmune diseases are characterized by an excessive reaction of the immune system against endogenous tissue. The immune system erroneously recognizes endogenous tissue as foreign bodies to be combated. This results in severe inflammatory reactions, which lead to damage to organs affected by them. An important part in distinguishing between endogenous and exogenous structures is played by T lymphocytes or T cells, which are “trained” in the thymus to dock only onto endogenous cell surface molecules, the so-called MHC molecules, and thus to tolerate endogenous structures. These processes are called “clonal deletion” and “clonal selection”. During the initial selection in the thymus, only those T cells, which are able to recognize MHC molecules on the endogenous cell membranes survive, while the binding is however not so strong that it could lead to activation of the T cells. T cells which cannot bind to or recognize endogenous MHC molecules at all are eliminated. In the clonal deletion also taking place in the thymus, those T cells which are able to “unerringly” recognize and strongly bind endogenous MHC molecules in such a manner that they would be activated, which would in the end lead to the destruction of endogenous cells, are eliminated. This process is one of those measures which the immune system takes in order to be able to protect the “self” and combat the “exogenous”. [0004] In autoimmune diseases, a group of the T cells behaves abnormally. In addition to the still functioning defence from exogenous molecules and organisms, they now also attack endogenous structure. Organs or tissues are perceived as exogenous. There can be various consequences: if vital structures are affected, an autoimmune disease will take a fatal course. The immune system directs its defence against these structures, cellular and also humoral defence reactions are set in motion, and autoantibodies are formed, as a result of which the organs affected in the course of time cease to function. Most commonly, the immune system is weakened and the body becomes susceptible to all kinds of diseases. Under some circumstances, recognition of the exogenous is also disrupted, and as a result the spreading of degenerated cancer cells can no longer be effectively prevented, and those affected are more susceptible to infectious diseases. In the course of the disease, cells of the immune system destroy the endogenous structures, while the body's repair mechanisms attempt as far as possible to regenerate the damaged organ parts. As a rule, without treatment this erroneous attack of the defensive system continues throughout life or until the complete destruction of the target structure. Autoimmune diseases are treated according to the organ affected. In this, the basic principle of the causal therapy is to suppress the activity of the immune system by administration of immunosuppressants, e.g., cortisone. These substances are characterized by multiple systemic side-effects and interactions, owing to which attempts have been made to develop new drugs which specifically influence the mechanisms involved in the disease event. Examples of this are natalizumab and infliximab. Natalizumab is a monoclonal antibody and selective inhibitor of IgG4, an adhesion molecule which is located on the surface of white blood cells. Natalizumab inhibits the migration of white blood cells into inflammation foci and is used for the treatment of particularly aggressive forms of plaque progressive multiple sclerosis. Infliximab is a chimeric monoclonal antibody against tumour necrosis factor .alpha. (TNF.alpha.), which plays a key part in autoimmune inflammatory reactions. Infliximab is used in rheumatoid arthritis, Crohn's disease, and psoriasis. SUMMARY OF THE INVENTION [0005] Certain embodiments of the teachings herein are directed to methods of inhibiting an autoimmune process, such as rheumatoid arthritis, comprising the steps of: a) obtaining a patient suffering from a pathological immune response against self-antigens; b) providing to said patient a Noble gas composition; and c) adjusting dosage and frequency of administration of said Noble gas composition based on immunological and/or clinical response. [0006] Various aspects of the invention relating to the above are enumerated in the following paragraphs: [0007] Aspect 1. A method of inhibiting an autoimmune process comprising the steps of: a) obtaining a patient suffering from a pathological immune response against self-antigens; b) providing to said patient a Noble gas composition; and c) adjusting dosage and frequency of administration of said Noble gas composition based on immunological and/or clinical response. [0008] Aspect 2. The method of aspect 1, wherein said autoimmune process is rheumatoid arthritis. [0009] Aspect 3. The method of aspect 2, wherein said rheumatoid arthritis patient is defined as suffering from at least one symptom of rheumatoid arthritis, the symptom selected from the group consisting of morning stiffness, painful joints, swollen joints, loss of grip strength, and pain. [0010] Aspect 4. The method of aspect 1, wherein said autoimmune process is selected from a group comprising of: multiple sclerosis, rheumatoid arthritis, type 1 diabetes, Crohns disease, ulcerative colitis, psoriasis, celiac disease, Acute disseminated encephalomyelitis (ADEM), Addison's disease, A gammaglobulinemia, Alopecia areata, Amyotrophic lateral sclerosis, Ankylosing Spondylitis, Antiphospholipid syndrome, Antisynthetase syndrome, Atopic allergy, Atopic dermatitis, Autoimmune aplastic anemia, Autoimmune cardiomyopathy, Autoimmune enteropathy, Autoimmune hemolytic anemia, Autoimmune hepatitis, Autoimmune inner ear disease, Autoimmune lymphoproliferative syndrome, Autoimmune peripheral neuropathy, Autoimmune pancreatitis, Autoimmune polyendocrine syndrome, Autoimmune progesterone dermatitis, Autoimmune thrombocytopenic purpura, Autoimmune uveitis, Behcet's disease, Celiac disease, Cold agglutinin disease, Crohn's disease, Dermatomyositis, Dermatomyositis, Eosinophilic fasciitis, Goodpasture's syndrome, Graves' disease, Guillain-Barre syndrome (GBS), Hashimoto's encephalopathy, Hashimoto's thyroiditis, Idiopathic thrombocytopenic purpura, Lupus erythematosus, Miller-Fisher syndrome, Mixed connective tissue disease, Myasthenia gravis, Narcolepsy, Pemphigus vulgaris, Pernicious anaemia, Polymyositis Primary biliary cirrhosis, Psoriasis, Psoriatic arthritis, Relapsing polychondritis, Rheumatic fever, Sjogren's syndrome, Temporal arteritis, Transverse myelitis, Ulcerative colitis, Undifferentiated connective tissue disease, Vasculitis, and Wegener's granulomatosis. [0011] Aspect 5. The method of aspect 1, wherein said Noble gas mixture contains oxygen and a proportion by volume of 20 to 70% of xenon. [0012] Aspect 6. The method of aspect 5, wherein said proportion of xenon is between 22 and 60% by volume to oxygen. [0013] Aspect 7. The method of aspect 6, wherein said proportion of xenon is between 25 and 60% by volume to oxygen. [0014] Aspect 8. The method of aspect 1, wherein said noble gas containing mixture consists only of a) oxygen and xenon or b) air and xenon. [0015] Aspect 9. The method of aspect 1, wherein said noble gas containing mixture also contains nitrogen, helium, Nitric Oxide, krypton, argon or neon. [0016] Aspect 10. The method of aspect 1, wherein said noble gas containing mixture contains a proportion by volume of oxygen of between 15 and 25%. [0017] Aspect 11. The method of aspect 1, wherein said noble gas containing mixture is supplied for inhalation from a pressurized container at a pressure greater than 2 bar. [0018] Aspect 12. The method of aspect 1, wherein said noble gas containing mixture is administered intranasally. [0019] Aspect 13. The method of aspect 1, wherein said noble gas containing mixture is administered through the use of a hyperbaric chamber. [0020] Aspect 14. The method of aspect 13, wherein said hyperbaric chamber is pressurized to a pressure of no more than 3 atm (0.3 MPa). [0021] Aspect 15. The method of aspect 14, wherein a noble gas is administered to the patient while the patient is in the hyperbaric environment. [0022] Aspect 16. The method of aspect 1 wherein said noble gas is administered by inhalation or simulated inhalation. [0023] Aspect 17. The method of aspect 1, wherein said noble gas is xenon, helium, or a mixture of xenon and helium. [0024] Aspect 18. The method of aspect 1, wherein the noble gas is xenon or a mixture of xenon and helium, and the partial pressure of xenon is no more than about 0.8 atm (0.08 MPa). [0025] Aspect 19. The method of aspect 1, wherein said noble gas is administered mixed with air, the air partial pressure being about 1 atm (0.1 MPa). [0026] Aspect 20. The method of aspect 1, wherein said noble gas is administered as part of a gas mixture comprising oxygen, the nitrogen partial pressure in the mixture being equal to or less than about 0.8 atm (0.08 MPa). [0027] Aspect 21. The method of aspect 20, wherein said gas mixture is essentially free of nitrogen. [0028] Aspect 22. The method of aspect 21, wherein the oxygen partial pressure is about 0.2 atm (0.02 MPa). [0029] Aspect 23. The method of aspect 1, wherein said clinical assessment is performed by the EULAR score. [0030] Aspect 24. The method of aspect 1, wherein said immunological assessment is performed by quantification of levels of inflammatory markers. [0031] Aspect 25. The method of aspect 24, wherein said inflammatory marker is CRP. [0032] Aspect 26. The method of aspect 24, wherein said inflammatory marker is IL-1. [0033] Aspect 27. The method of aspect 24, wherein said inflammatory marker is IL-6. [0034] Aspect 28. The method of aspect 24, wherein said inflammatory marker is IL-8. [0035] Aspect 29. The method of aspect 24, wherein said inflammatory marker is IL-17. [0036] Aspect 30. The method of aspect 24, wherein said inflammatory marker is TNF-alpha. [0037] Aspect 31. The method of aspect 24, wherein said inflammatory marker is HMGB -1. [0038] Aspect 32. The method of aspect 24, wherein said inflammatory marker is IL-33. [0039] Aspect 33. A method increasing sensitivity to an anti-cytokine biologic in a rheumatoid arthritis patient, said method comprising administration of a Noble gas containing mixture. [0040] Aspect 34. A method of inducing antigen specific tolerance, said method comprising generation of a particle containing a Noble gas together with an antigen to which tolerance is desired. [0041] Aspect 35. A method of reducing pain in a patient with rheumatoid arthritis comprising administration of a therapeutically sufficient concentration and frequency of a Noble gas. DETAILED DESCRIPTION OF THE INVENTION [0042] The invention teaches the counterintuitive findings that xenon administration induces an increase in anti-inflammatory/immune modulatory processes that are useful in the treatment of, and/or amelioration of rheumatoid arthritis. Rheumatoid arthritis (RA) is an autoimmune condition characterized by adaptive immune autoreactivity leading to chronic inflammation of the synovium and the presence of rheumatoid arthritis synovial fibroblasts (RASFs) that undergo hyperplasia and invade cartilage and bone [1]. RASFs exhibit an increased ability to enter into the cell cycle, resulting in hyperplasia [2], and also show a decreased ability to undergo apoptosis [3]. RASFs produce proinflammatory cytokines, such as IL-1 and TNF-α which provide further stimulation for the ongoing inflammation[4]. Furthermore, enzymes including stromelysin and collagenase are produced and are capable of invading cartilage and bone [5]. [0043] Clinically, RA affects approximately 0.5-1% of the global population [6] with varying degrees of severity. The typical treatment algorithm involves initiation of NSAIDS, however more recent practice has been concurrent initiation of disease modifying antirheumatic drugs (DMARDs). These agents are slow acting but have been demonstrated to inhibit radiological progression of RA. Such agents typically include: 1) hydroxychloroquine, which acts in part as a toll like receptor (TLR) 7/9 antagonist, thus decreasing innate immune activation [7]; 2) Leflunomide, an antimetabolite that inhibits pyrimidine synthesis and protein tyrosine kinase activity [8], which results in suppression of T cell responses [9], and has been also demonstrated to inhibit dendritic cell (DC) activation [10]; 3) Injectable gold compounds such as auranofin which directly or through metabolites such as dicyanogold(i) have been demonstrated to inhibit T cell and antigen presenting cell activation [11, 12], as well as cause Th2 deviation [13]; 4) Sulfasalazine, was used since 1950, acts primarily through inhibition of cycloxygenase and lipoxygenase [14]; and 5) Methotrexate, an antifolate that inhibits T cell activation and proliferation, that has been one of the golden standards for RA [15]. Typically combinations of DMARDs with glucocorticoids are used, or alternatively pulse of high dose glucocorticoids are administered to cause a general inhibition of inflammation [16]. [0044] The field of RA therapy has been revolutionized by the introduction of the TNF-✓-targeting agents, Remicade, Enbrel, and Humira, sometimes referred to as “biological DMARDs.” These are implemented primarily after response to conventional DMARDs has failed [17]. Although improvement in quality of life has occurred as a result of biological DMARDs, substantial progress remains to be made. For example, TNF-alpha blockers have been associated with reactivation of infectious disease, autoantibody formation and the possibility of increased lymphoma risk [18, 19]. Thus to date, one of the major limitations to RA therapy has been lack of ability to specifically inhibit autoreactive responses while allowing other immune components to remain intact. [0045] An “autoimmune disease” herein is any non-malignant disease or disorder arising from antibodies that are produced directed against an individual's own (self) antigens and/or tissues. [0046] “Immunosuppressive drugs” are any molecules that interfere with the immune system and blunt its response to foreign or self antigens. Cyclophosphamide (CYC) and mycophenolate mofetil (MMF) are two such kinds of molecules. This term is intended to encompass any drug or molecule useful as a therapeutic agent in downregulating the immune system. This method particularly contemplates drugs that have been used to treat autoimmune diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus erythematosus (SLE), lupus nephritis (LN), Wegener's disease, inflammatory bowel disease, idiopathic thrombocytopenic purpura (ITP), thrombotic throbocytopenic purpura (TTP), autoimmune thrombocytopenia, multiple sclerosis, psoriasis, IgA nephropathy, IgM polyneuropathies, myasthenia gravis, vasculitis, diabetes mellitus, Reynaud's syndrome, Sjorgen's syndrome and glomerulonephritis. [0047] Antibody “effector functions” refer to those biological activities attributable to the Fc region (a native sequence Fc region or amino acid sequence variant Fc region) of an antibody, and vary with the antibody isotype. Examples of antibody effector functions include: Clq binding and complement dependent cytotoxicity; Fc receptor binding; antibody-dependent cell-mediated cytotoxicity (ADCC); phagocytosis; down regulation of cell surface receptors (e.g. B cell receptor); and B cell activation. [0048] “Antibody-dependent cell-mediated cytotoxicity” or “ADCC” refers to a form of cytotoxicity in which secreted Ig bound onto Fc receptors (FcRs) present on certain cytotoxic cells (e.g. Natural Killer (NK) cells, neutrophils, and macrophages) enable these cytotoxic effector cells to bind specifically to an antigen-bearing-target cell and subsequently kill the-target cell with cytotoxins. The antibodies-“arm” the cytotoxic cells and are absolutely required for such killing. The primary cells for mediating ADCC, NK cells, express Fc.gamma.RIII only, whereas monocytes express FcyRI, FcyRII and FcyRIII. FcR expression on hematopoietic cells is summarized in Table 3 on page 464 of Ravetch and Kinet, Ann. Rev. Immunol 9: 457-92 (1991). To assess ADCC activity of a molecule of interest, an in vitro ADCC assay, such as that described in U.S. Pat. No. 5,500,362 or 5,821,337 may be performed. Useful effector cells for such assays include peripheral blood mononuclear cells (PBMC) and Natural Killer (NK) cells. Alternatively, or additionally, ADCC activity of the molecule of interest may be assessed in vivo, e.g., in a animal model such as that disclosed in Clynes et al. PNAS (USA) 95: 652-656 (1998). [0049] “Complement dependent cytotoxicity” or “CDC” refers to the lysis of a target cell in the presence of complement. Activation of the classical complement pathway is initiated by the binding of the first component of the complement system (Clq) to antibodies (of the appropriate subclass) which are bound to their cognate antigen. To assess complement activation, a CDC assay, e.g. as described in Gazzano-Santoroetal., J. Immunol. Methods 202: 163 (1996), may be performed. [0050] The term “anti-inflammatory agent” as used herein, refers to any compound having known effectiveness to reduce symptoms of inflammation. For example, reduction in symptoms may include, but are not limited to, reduced swelling, redness and/or local lymphocyte levels. For example, an anti-inflammatory agent may include, but is not limited to, aspirin, acetominophen, ibuprofen, cortiocosterone, or cortisol. [0051] The terms “reduce,” “inhibit,” “diminish,” “suppress,” “decrease,” “prevent” and grammatical equivalents (including “lower,” “smaller,” etc.) when in reference to the expression of any symptom in an untreated subject relative to a treated subject, mean that the quantity and/or magnitude of the symptoms in the treated subject is lower than in the untreated subject by any amount that is recognized as clinically relevant by any medically trained personnel. In one embodiment, the quantity and/or magnitude of the symptoms in the treated subject is at least 10% lower than, at least 25% lower than, at least 50% lower than, at least 75% lower than, and/or at least 90% lower than the quantity and/or magnitude of the symptoms in the untreated subject. [0052] The term “drug”, “agent” or “compound” as used herein, refers to any pharmacologically active substance capable of being administered which achieves a desired effect. Drugs or compounds can be synthetic or naturally occurring, non-peptide, proteins or peptides, oligonucleotides, or nucleotides (DNA and/or RNA), polysaccharides or sugars. [0053] The term “administered” or “administering”, as used herein, refers to any method of providing a composition to a patient such that the composition has its intended effect on the patient. For example, one method of administering is by an indirect mechanism using a medical device such as, but not limited to a catheter, applicator gun, syringe etc. A second exemplary method of administering is by a direct mechanism such as, local tissue administration (i.e., for example, extravascular placement), oral ingestion, transdermal patch, topical, inhalation, suppository etc. [0054] The term “patient”, as used herein, is a human or animal and need not be hospitalized. For example, out-patients, and persons in nursing homes are “patients.” A patient may comprise any age of a human or non-human animal and therefore includes both adult and juveniles (i.e., children). It is not intended that the term “patient” connote a need for medical treatment, therefore, a patient may voluntarily or involuntarily be part of experimentation whether clinical or in support of basic science studies. [0055] The term “pharmaceutically” or “pharmacologically acceptable”, as used herein, refer to molecular entities and compositions that do not produce adverse, allergic, or other untoward reactions when administered to an animal or a human. [0056] The term, “pharmaceutically acceptable carrier”, as used herein, includes any and all solvents, or a dispersion medium including, but not limited to, water, ethanol, polyol (for example, glycerol, propylene glycol, and liquid polyethylene glycol, and the like), suitable mixtures thereof, and vegetable oils, coatings, isotonic and absorption delaying agents, liposome, commercially available cleansers, and the like. Supplementary bioactive ingredients also can be incorporated into such carriers. [0057] The term “biologically active” refers to any molecule having structural, regulatory or biochemical functions. For example, biological activity may be determined, for example, by restoration of wild-type growth in cells lacking protein activity. Cells lacking protein activity may be produced by many methods (i.e., for example, point mutation and frame-shift mutation). Complementation is achieved by transfecting cells which lack protein activity with an expression vector which expresses the protein, a derivative thereof, or a portion thereof. [0058] In one aspect of the invention, Noble gas mixtures are administered to treat autoimmunity. Further, it is preferable if the autoimmune disease is selected from the group consisting of: type I diabetes mellitus, rheumatoid arthritis, multiple sclerosis, chronic gastritis, Crohn's disease, Basedow disease, Bechterew disease, psoriasis, myasthenia gravis, autoimmune hepatitis, APECED, Chrug-Strauss syndrome, ulcerative colitis, glomerulonephritis, Guillain-Barre syndrome, Hashimoto thyroiditis, lichen sclerosus, systemic lupus erythematosis, PANDAS, rheumatic fever, sarcoidosis, Sjorgren syndrome, Stiff-Man syndrome, scleroderma, Wegener's granulomatosis, vitiligo, Wegener's disease, inflammatory bowel disease, idiopathic thrombocytopenic purpura (ITP), thrombotic throbocytopenic purpura (TTP), autoimmune thrombocytopenia, multiple sclerosis, psoriasis, IgA nephropathy, IgM polyneuropathies, myasthenia gravis, vasculitis, diabetes mellitus, Reynaud's syndrome, Sjorgen's syndrome and glomerulonephritis, autoimmune enteropathy, Goodpasture syndrome, dermatomyositis, polymyositis, autoimmune allergy, asthma and autoimmune reaction after organ transplantations. [0059] Amounts effective will depend, of course, on the particular subject being treated; the severity of a condition, disease or disorder; the individual patient parameters including age, physical condition, size and weight; the duration of the treatment; the nature of concurrent therapy (if any); the specific route of administration and like factors within the knowledge and expertise of the health practitioner. These factors are well known to those of ordinary skill in the art and can be addressed with no more than routine experimentation. It is generally preferred that a maximum dose be used, that is, the highest safe dose according to sound medical judgment. It will be understood by those of ordinary skill in the art, however, that a patient may insist upon a lower dose or tolerable dose for medical reasons, psychological reasons or for virtually any other reason. [0060] In one embodiment of the invention, patients suffering from RA are administered xenon at a concentration of 25% xenon in 75% air. Various concentrations may be performed and adjusted based on immunological and clinical responses. In a preferred embodiment administration of xenon is performed 3 times per week in a volume of 10 liters, with a concentration of 25% xenon and 75% air. Other gases such as argon, helium, neon and krypton may be utilized. Additionally, other excipients may be added to alter immunological parameters. In order to guide of skill in the art in the practice of the invention, a table of some of the immunological intervention clinical trials for RA is provided below. This table may serve to guide a practitioner of the invention in choosing immunological and clinical parameters for assessment. [0000] Phase I/II Studies in RA Number of Experimental Patients Drug Endpoints Reference 20 Antibody to TNF- Safety, morning stiffness, VAS pain scale, [20] alpha number of swollen joints, 5 point symptom scale, Health Assessment Questionnaire, Richie articular index 30 Antibody to IL-15 Safety, tender joint count, swollen joint count, [21] early morning stiffness, pain score (visual analog scale), patient global assessment, physician global assessment, Health Assessment Questionnaire, American College of Rheumatology Response Score  8 Autologous stem Safety, swollen joint count, duration of morning [22] cell and stiffness (in minutes), pain score using a 100- cyclophosphamide mm visual analog scale (VAS), disability section of the Health Assessment Questionnaire 24 Anti-CD4 Safety, American College of Rheumatology [23] antibody Response Score, RA-specific Health Assessment Questionnaire 16 Oral CCR1 28 joint count for joint swelling and tenderness, [24] antagonist doctor's and patient's assessment of disease activity on a scale from 1 (asymptomatic) to 5 (severe symptoms), pain assessed by a visual analogue scale from 0 (no pain) to 100 (severe pain), quality of life (Health Assessment Questionnaire (HAQ)) from 0 (no disability) to 3 (severe disability) [0061] For monitoring RA disease activity for this rheumatoid arthritis trial, a 28-joint count for tenderness and swelling is employed. To assess the tender joint count, the examiner documents which joints the patient indicates are painful on palpation with enough pressure to blanch the nail bed of the examiner's thumb and index fingers. To assess the swollen joint count, the examiner documents which joints have palpable soft tissue swelling or fluctuance, excluding joints affected only by deformity or bony hypertrophy. The 28-joint count includes the shoulders, elbows, wrists, first to fifth metacarpophalangeal joints, first to fifth proximal interphalangeal joints, and knees on both sides of the body. Compared to more extensive joint counts, the 28-joint count has the advantage of being quick and easy to perform; however, it is limited by the fact that the ankles and metatarsophalangeal joints are not included, so active disease in the feet may be underestimated. The 28-joint count is used to calculate the disease activity score 28 (DAS28), which is a validated instrument to monitor disease activity. [0062] This is performed as follows: [0063] 1. Perform a swollen and tender joint examination of your patient, noting each affected joint on Form A. When complete, add all of the swollen and tender joints and record the totals in the appropriate boxes on Form B. [0064] 2. Obtain and record the patient's erythrocyte sedimentation rate (ESR) in mm/h in the appropriate box on Form B. Note: C-reactive protein (CRP) levels may be used as a substitute for an ESR. [0065] 3. Obtain and record the patient's general health on a Visual Analog Scale (VAS) of 100 mm in the appropriate box on Form B. Note: DAS28 calculations may be performed without a VAS measurement. [0066] 4. Plug the appropriate values into the formula: DAS28=0.56*√{square root over ( )}(tender joints)+0.28*√{square root over ( )}(swollen joints)+0.70*Ln(ESR/CRP)+0.014*VAS [0067] 5. A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6. [0000] Left Right Swollen Tender Swollen Tender FORM A Shoulder Elbow Wrist Metacarpophalangeal (MCP) 1 2 3 4 5 Proximal Interphalangeal (PIP) 1 2 3 4 5 Knee Subtotal TOTAL Total Swollen: Total Tender: FORM B Swollen (0-28) Tender (0-28) ESR (or CRP) VAS disease activity (0-100 mm) indicates data missing or illegible when filed [0068] The EULAR response criteria include not only change in disease activity but also current disease activity. To be classified as responders, patients should have a significant change in DAS and also low current disease activity. Three categories are defined: good, moderate, and non-responders. EULAR response criteria combine the DAS28 score at the time of evaluation with the change in DAS28 score between two time points, and enable the user to define improvement or response to treatment. The thresholds for low disease activity and remission and the EULAR response criteria provide a standardised guide on how to interpret the DAS28 scores [0069] The HAQ was developed as a comprehensive measure of outcome in patients with a wide variety of rheumatic diseases, including rheumatoid arthritis, osteoarthritis, juvenile rheumatoid arthritis, lupus, scleroderma, ankylosing spondylitis, fibromyalgia, and psoriatic arthritis. It has also been applied to patients with HIV/AIDS and in studies of normal aging. It should be considered a generic rather than a disease-specific instrument. Its focus is on self-reported patient-oriented outcome measures, rather than process measures. [0070] Thus, in one embodiment of the invention, therapeutic Noble Gas compositions are administered in a manner to alter immunological factors in the body. Specifically, the invention teaches that various concentrations of xenon gas, when delivered into circulation, either by inhalation [25-27], or administration of echogenic xenon liposomes [28, 29], can be utilized to induce a T regulatory cell phenotype and suppression of Th17 or other arthritogenic cells. The use of xenon has been reviewed by numerous authors in the art, which provide guidance as to details of administration [30-32]. Importantly, the new and non-obvious aspect of the current invention is that xenon, as well as other Noble gases, are capable of inducing immune modulation to inhibit autoimmunity, as well as to inhibit pain associated with RA. [0071] Examples of gases or gas mixtures employed as medicament for radiation protection: 1.) 100% by volume xenon; 2.) 70% by volume xenon/30% by volume oxygen; 3.) 65% by volume xenon/30% by volume oxygen/5% by volume nitrogen; 4.) 65% by volume xenon/35% by volume oxygen; 5.) 60% by volume xenon/30% by volume oxygen/10% by volume nitrogen; 6.) 60% by volume xenon/35% by volume oxygen/5% by volume nitrogen; 7.) 60% by volume xenon/40% by volume oxygen; 8.) 55% by volume xenon/25% by volume oxygen/20% by volume nitrogen; 9.) 55% by volume xenon/30% by volume oxygen/15% by volume nitrogen; 10.) 55% by volume xenon/35% by volume oxygen/10% by volume nitrogen; 11.) 55% by volume xenon/40% by volume oxygen/5% by volume nitrogen; 12.) 55% by volume xenon/45% by volume oxygen; 13.) 50% by volume xenon/50% by volume oxygen; 14.) 50% by volume xenon/45% by volume oxygen/5% by volume nitrogen; 15.) 50% by volume xenon/40% by volume oxygen/10% by volume nitrogen; 16.) 50% by volume xenon/30% by volume oxygen/20% by volume nitrogen; 17.) 50% by volume xenon/25% by volume oxygen/25% by volume nitrogen; 18.) 45% by volume xenon/55% by volume oxygen; 19.) 45% by volume xenon/50% by volume oxygen/5% by volume nitrogen; 20.) 45% by volume xenon/45% by volume oxygen/10% by volume nitrogen; 21.) 45% by volume xenon/40% by volume oxygen/15% by volume nitrogen; 22.) 45% by volume xenon/35% by volume oxygen/20% by volume nitrogen; 23.) 45% by volume xenon/30% by volume oxygen/25% by volume nitrogen; 24.) 45% by volume xenon/30% by volume oxygen/25% by volume nitrogen; 25.) 40% by volume xenon/30% by volume oxygen/30% by volume nitrogen; 26.) 40% by volume xenon/50% by volume oxygen/10% by volume nitrogen; 27.) 35% by volume xenon/25% by volume oxygen/40% by volume nitrogen; 28.) 35% by volume xenon/65% by volume oxygen; 29.) 30% by volume xenon/70% by volume oxygen; 30.) 30% by volume xenon/50% by volume oxygen/20% by volume nitrogen; 31.) 30% by volume xenon/30% by volume oxygen/40% by volume nitrogen; 32.) 20% by volume xenon/80% by volume oxygen; 33.) 20% by volume xenon/30% by volume oxygen/50% by volume nitrogen; 34.) 15% by volume xenon/30% by volume oxygen/55% by volume nitrogen; 35.) 15% by volume xenon/50% by volume oxygen/35% by volume nitrogen; 36.) 10% by volume xenon/90% by volume oxygen; 37.) 10% by volume xenon/50% by volume oxygen/40% by volume nitrogen; 38.) 10% by volume xenon/30% by volume oxygen/60% by volume nitrogen; 39.) 10% by volume xenon/25% by volume oxygen/65% by volume nitrogen; 40.) 5% by volume xenon/25% by volume oxygen/70% by volume nitrogen; 41.) 5% by volume xenon/30% by volume oxygen/65% by volume nitrogen; 42.) 5% by volume xenon/50% by volume oxygen/45% by volume nitrogen; 43.) 5% by volume xenon/30% by volume oxygen/65% by volume nitrogen; 44.) 5% by volume xenon/95% by volume oxygen; 45.) 1% by volume xenon/99% by volume oxygen; 46.) 1% by volume xenon/30% by volume oxygen/69% by volume nitrogen; 47.) 1% by volume xenon/25% by volume oxygen/74% by volume nitrogen. [0072] In an expanded use of the invention, a wider variety of autoimmune conditions may be treated, said conditions may be treated by said Noble gas containing compositions, or may be treated by combinations with existing immune modulator drugs and Noble gas containing compositions. In a more selected manner, the invention may be utilized by administration of antigen-specific tolerogenic vaccines with said Noble gas containing compositions. Autoimmune diseases include refers to any disease or disorder in which an immune response is generated in response to a substance, such as a protein or a tissue, that is normally present in the body and such response is undesirable. Generally, such a disease or disorder includes undesired immune responses to one or more self antigens. Autoimmune disease and autoimmune disorder may be used interchangeably through the disclosure and are considered to be synonymous. The list of autoimmune diseases may include, but is not limited to, multiple sclerosis, rheumatoid arthritis, type 1 diabetes, Crohns disease, ulcerative colitis, psoriasis, etc. Autoimmune diseases may also include diseases induced by foreign antigens, such as celiac disease. Non-limiting examples of autoimmune diseases also include Acute disseminated encephalomyelitis (ADEM), Addison's disease, Agammaglobulinemia, Alopecia areata, Amyotrophic lateral sclerosis, Ankylosing Spondylitis, Antiphospholipid syndrome, Antisynthetase syndrome, Atopic allergy, Atopic dermatitis, Autoimmune aplastic anemia, Autoimmune cardiomyopathy, Autoimmune enteropathy, Autoimmune hemolytic anemia, Autoimmune hepatitis, Autoimmune inner ear disease, Autoimmune lymphoproliferative syndrome, Autoimmune peripheral neuropathy, Autoimmune pancreatitis, Autoimmune polyendocrine syndrome, Autoimmune progesterone dermatitis, Autoimmune thrombocytopenic purpura, Autoimmune uveitis, Behcet's disease, Celiac disease, Cold agglutinin disease, Crohn's disease, Dermatomyositis, Dermatomyositis, Diabetes mellitus type 1, Eosinophilic fasciitis, Goodpasture's syndrome, Graves' disease, Guillain-Barre syndrome (GB S), Hashimoto's encephalopathy, Hashimoto's thyroiditis, Idiopathic thrombocytopenic purpura, Lupus erythematosus, Miller-Fisher syndrome, Mixed connective tissue disease, Multiple sclerosis, Myasthenia gravis, Narcolepsy, Pemphigus vulgaris, Pernicious anaemia, Polymyositis Primary biliary cirrhosis, Psoriasis, Psoriatic arthritis, Relapsing polychondritis, Rheumatoid arthritis, Rheumatic fever, Sjogren's syndrome, Temporal arteritis, Transverse myelitis, Ulcerative colitis, Undifferentiated connective tissue disease, Vasculitis, and Wegener's granulomatosis. In some embodiments, the autoimmune disease is Multiple Sclerosis (MS). Generally, the autoimmune disease or disorder is T-cell-mediated. Example: Treatment of 20 DMARD-Resistant RA Patients with Xenon [0073] 20 patients with disease modifying antirheumatic drug (DMARD)-resistant Rheumatoid Arthritis (RA) are chosen for a clinical trial assessing safety and efficacy of 25% Xenon administration with 75% air. A total of 10 liters of gas inhaled. Administration is performed 3 times per week. [0074] The number of 20 patients has been chosen based on previous clinical trials aiming to identify a signal of efficacy with demonstration of feasibility and safety [20-24]. [0075] Safety is determined by assessment of hematological biochemical, and coagulation parameters on baseline, and days 30, 60, and 90. Efficacy is assessed by CRP, ESR, anti-citrulline antibody, RF, Quality of Life Questionnaire, 28-joint disease activity score (DAS28), European League against Rheumatism (EULAR) response criteria and immunological parameters. [0076] Men and women at least 18 years of age are eligible to participate if they meet the American College of Rheumatology (ACR) criteria for RA for at least one year and are in functional Class I, II, or III [33]. All patients will have to have had at least one failed trial of a DMARD and must have at least 10 painful and 10 swollen joints at entry. No DMARD therapy is allowed within 4 weeks of study entry. Patients receiving nonsteroidal anti-inflammatory drugs, corticosteroids (<10 mg per day), or both will be allowed in the trial if they have been on stable doses for at least four weeks before study entry. Required baseline laboratory values include serum creatinine and blood urea nitrogen<1.5× the upper limit of normal and alanine aminotranferase and aspartate aminotransferase<2.0× the upper limit of normal. Exclusionary laboratory values include a platelet count of >500,000/mm3, hematocrit<30%, and a white-blood-cell count<3000/mm3. Other exclusionary criteria include history of cancer, use of intravenous or intraarticular corticosteroids within four weeks of randomization, any prior use of cyclosporine or cyclophosphamide, use of any investigational agent within 30 days of study entry, severe extra-articular manifestations of RA, acute infection requiring antibiotic therapy within two weeks of study entry, other concurrent autoimmune disease (e.g. systemic lupus erythematosus), or any other condition that the investigator thought might have placed the patient at undue risk if they had participated in the trial. Men and women of childbearing potential are to use approved methods of birth control. Women have to have a negative result on a test of serum beta human chorionic gonadotropin at screening. Medications including cyclosporine, cyclophosphamide, and any DMARD will not allowed. The use of intravenous or intra-articular corticosteroids will not be permitted. The following analgesics are permitted: acetaminophen, acetaminophen with codeine, acetaminophen with oxycodone, and propoxyphene. Patients will be instructed not to take analgesics within 12 hours of their planned study visit. [0077] The primary objective of this feasibility study is to provide clinical data to demonstrate the safety and efficacy of xenon administration 10 liters at 25% xenon, 3 times per week for the duration of the trial in treating patients diagnosed with DMARD-resistant rheumatoid arthritis (RA). [0078] The secondary objectives are to demonstrate that xenon administration impacts the clinical course of RA resistant to DMARDS as measured by QOL questionnaire, 28 joint DAS and EULAR criteria, and to assess the effect of the xenon therapy on immunological/inflammatory parameters including CRP, RF, anti-citrulinated antibodies. [0079] Safety will be assessed throughout the study with the use of direct evaluation and patient reporting during study visits or patient-initiated telephone contacts. The types, frequencies, severity, and duration of any reported adverse event or abnormalities in clinical laboratory values, physical examinations, vital signs, or special cardiovascular evaluations will be assessed. The changes from baseline will be summarized. [0080] Safety data to be summarized include by not limited to: Adverse Events/Serious Adverse Events Complete blood count Physical assessment/vital signs ECG [0085] To assess preliminary evidence of efficacy, the following assessments will be analyzed at following time points and compared to baseline values: [0086] Disease Severity at 1, 2, and 3 Months: Changes in 28-joint disease activity score (DAS28) Changes in European League against Rheumatism (EULAR) response criteria Reduction in RF, ESR, CRP and anti-citrulinated fibrinogen antibody [0090] Quality of Life Assessment at 1, 2, and 3 Months Measured by: Change in Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire [0092] Subsequent to therapy, patients demonstrate no significant treatment associated adverse events and reduction of clinical and immunological parameters of RA is noted in a statistically significant manner. REFERENCES [0093] 1. Ziff, M., Rheumatoid arthritis—its present and future . J Rheumatol, 1990. 17(2): p. 127-33. [0094] 2. Perlman, H., L. J. Pagliari, and M. V. Volin, Regulation of apoptosis and cell cycle activity in rheumatoid arthritis . Curr Mol Med, 2001. 1(5): p. 597-608. [0095] 3. Zhang, H. G., et al., Regulation of tumor necrosis factor alpha - mediated apoptosis of rheumatoid arthritis synovial fibroblasts by the protein kinase Akt . Arthritis Rheum, 2001. 44(7): p. 1555-67. [0096] 4. Firestein, G. S. and M. M. Paine, Stromelysin and tissue inhibitor of metalloproteinases gene expression in rheumatoid arthritis synovium . Am J Pathol, 1992. 140(6): p. 1309-14. [0097] 5. Wernicke, D., et al., Stimulation of collagenase 3 expression in synovial fibroblasts of patients with rheumatoid arthritis by contact with a three - dimensional collagen matrix or with normal cartilage when coimplanted in NOD/SCID mice . Arthritis Rheum, 2002. 46(1): p. 64-74. [0098] 6. FIRESTEIN, G.E.a.P.o.R.A.I.H.R., Edward D.;, M. C. F. Genovese, Gary S.; Sargent, John S.; Sledge, Clement B., editors. Kelley's, and P. Textbook of Rheumatology. Vol. 7. Philadelphia, USA: Elsevier Saunders; 2005. p. 996-1042. [0099] 7. Sun, S., et al., TLR 7/9 antagonists as therapeutics for immune - mediated inflammatory disorders . Inflamm Allergy Drug Targets, 2007. 6(4): p. 223-35. [0100] 8. Chong, A. S., et al., In vivo activity of leflunomide: pharmacokinetic analyses and mechanism of immunosuppression . Transplantation, 1999. 68(1): p. 100-9. [0101] 9. Dimitrova, P., et al., Restriction of de novo pyrimidine biosynthesis inhibits Th 1 cell activation and promotes Th 2 cell differentiation . J Immunol, 2002. 169(6): p. 3392-9. [0102] 10. Kirsch, B. M., et al., The active metabolite of leflunomide, A 77 1726, interferes with dendritic cell function . Arthritis Res Ther, 2005. 7(3): p. R694-703. [0103] 11. Tepperman, K., et al., Dicyanogold effects on lymphokine production . Met Based Drugs, 1999. 6(4-5): p. 301-9. [0104] 12. Han, S., et al., Auranofin, an immunosuppressive drug, inhibits MHC class I and MHC class II pathways of antigen presentation in dendritic cells . Arch Pharm Res, 2008. 31(3): p. 370-6. [0105] 13. Kim, T. S., et al., Inhibition of interleukin -12 production by auranofin, an anti - rheumatic gold compound, deviates CD 4(+) T cells from the Th 1 to the Th 2 pathway. Br J Pharmacol, 2001. 134(3): p. 571-8. [0106] 14. Taggart, A. J., Sulphasalazine in arthritis—an old drug rediscovered . Clin Rheumatol, 1987. 6(3): p. 378-83. [0107] 15. Bansard, C., et al., Can rheumatoid arthritis responsiveness to methotrexate and biologics be predicted ? Rheumatology (Oxford), 2009. 48(9): p. 1021-8. [0108] 16. Bijlsma, J. W., et al., Are glucocorticoids DMARDs ? Ann NY Acad Sci, 2006. 1069: p. 268-74. [0109] 17. Nanda, S. and J. M. Bathon, Etanercept: a clinical review of current and emerging indications . Expert Opin Pharmacother, 2004. 5(5): p. 1175-86. [0110] 18. Shakoor, N., et al., Drug - induced systemic lupus erythematosus associated with etanercept therapy . Lancet, 2002. 359(9306): p. 579-80. [0111] 19. Dinarello, C. A., Anti - cytokine therapeutics and infections . Vaccine, 2003. 21 Suppl 2: p. S24-34. [0112] 20. Elliot, M. J., et al., Treatment of rheumatoid arthritis with chimeric monoclonal antibodies to tumor necrosis factor alpha . Arthritis Rheum, 2008. 58(2 Suppl): p. S92-S101. [0113] 21. Baslund, B., et al., Targeting interleukin -15 in patients with rheumatoid arthritis: a proof - of - concept study . Arthritis Rheum, 2005. 52(9): p. 2686-92. [0114] 22. Snowden, J. A., et al., A phase I/II dose escalation study of intensified cyclophosphamide and autologous blood stem cell rescue in severe, active rheumatoid arthritis . Arthritis Rheum, 1999. 42(11): p. 2286-92. [0115] 23. Choy, E. H., et al., Pharmacokinetic, pharmacodynamic and clinical effects of a humanized IgG 1 anti -CD4 monoclonal antibody in the peripheral blood and synovial fluid of rheumatoid arthritis patients . Rheumatology (Oxford), 2000. 39(10): p. 1139-46. [0116] 24. Haringman, J. J., et al., Chemokine blockade and chronic inflammatory disease: proof of concept in patients with rheumatoid arthritis . Ann Rheum Dis, 2003. 62(8): p. 715-21. [0117] 25. Laitio, R., et al., Effect of Inhaled Xenon on Cerebral White Matter Damage in Comatose Survivors of Out - of - Hospital Cardiac Arrest: A Randomized Clinical Trial . JAMA, 2016. 315(11): p. 1120-8. [0118] 26. Arola, O. J., et al., Feasibility and cardiac safety of inhaled xenon in combination with therapeutic hypothermia following out - of - hospital cardiac arrest . Crit Care Med, 2013. 41(9): p. 2116-24. [0119] 27. Azzopardi, D., et al., Moderate hypothermia within 6 h of birth plus inhaled xenon versus moderate hypothermia alone after birth asphyxia ( TOBY - Xe ): a proof - of - concept, open - label, randomised controlled trial . Lancet Neurol, 2015. [0120] 28. Britton, G. L., et al., In vivo therapeutic gas delivery for neuroprotection with echogenic liposomes . Circulation, 2010. 122(16): p. 1578-87. [0121] 29. Peng, T., et al., Therapeutic time window and dose dependence of xenon delivered via echogenic liposomes for neuroprotection in stroke . CNS Neurosci Ther, 2013. 19(10): p. 773-84. [0122] 30. Maze, M., Preclinical neuroprotective actions of xenon and possible implications for human therapeutics: a narrative review . Can J Anaesth, 2016. 63(2): p. 212-26. [0123] 31. Sanders, R. D. and M. Maze, Xenon: from stranger to guardian . Curr Opin Anaesthesiol, 2005. 18(4): p. 405-11. [0124] 32. Esencan, E., et al., XENON in medical area: emphasis on neuroprotection in hypoxia and anesthesia . Med Gas Res, 2013. 3(1): p. 4. [0125] 33. Hochberg, M. C., et al., The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis and rheumatism, 1992. 35(5): p. 498-502. [0126] The references provided herein are expressly incorporated by reference in their entirties.

The invention disclosed provides means of inhibiting, ameliorating, and/or treatment of rheumatoid arthritis through the use of Noble gas containing mixtures. In one embodiment, the invention provides means of reducing inflammation and immune associated pathology through administration of Noble gas mixtures. In one specific embodiment, Xenon gas is administered to a patient in need at concentrations and frequencies sufficient to inhibit inflammatory and autoimmune processes. In another embodiment Noble gas mixtures are administered to reduce pain and provide symptomatic relieve to a patient suffering from rheumatoid arthritis. In another embodiment the use of Noble gas containing mixtures is disclosed as a means of reducing joint destruction through inhibition of matrix metalloprotease production and activity.

CROSS-REFERENCED RELATED APPLICATIONS [0001] This application is a continuation of International Patent Application No. PCT/CH2007/000397 filed Aug. 14, 2007, which claims priority to German Patent Application No. DE 10 2006 038 123.8 filed Aug. 14, 2006, German Patent Application No. DE 20 2006 019 890.3 filed Aug. 14, 2006, German Patent Application No. DE 10 2006 057 578.4 filed Dec. 6, 2006, German Patent Application No. DE 20 2006 019 370.7 filed Dec. 22, 2006 and German Patent Application No. DE 10 2007 001 432.7 filed Jan. 9, 2007, the entire content of all of which is incorporated herein by reference. BACKGROUND [0002] The present invention relates to devices for delivering, injecting, infusing, dispensing or administering a substance, and to methods of making and using such devices. More particularly, it relates to devices, structures and/or mechanisms for setting, controlling or selecting an amount or dose of a substance to be injected or dispensed from such devices. More particularly, it relates to a lock element for locking a dose setting mechanism of an injection device, e.g. an injection device for use with a two-chamber ampoule in which two substances are contained separately from one another and are mixed prior to administering by the injection device. [0003] If a two-chamber ampoule is incompletely or only partially screwed into an injection device, there is a possibility that the substances contained in the two-chamber ampoule will not be mixed or will be only partially mixed, in which case unmixed substances or an incompletely mixed substance could be dispensed during an injection operation. SUMMARY [0004] One object of the present invention is to provide an element for injection devices, by which the use of injection devices can be made more reliable, including in conjunction with two-chamber ampoules. [0005] In one embodiment, a lock element in accordance with the present invention is used to lock a setting, priming or dose setting mechanism or a setting, priming or dose setting element of an injection device, e.g. a disposable injector or an injection pen. [0006] In one embodiment, the present invention comprises a lock for a dosing mechanism of an injection device, the lock including at least one holding element that interacts with the dosing mechanism, or with a dosing element of the dosing mechanism, whereby an adjustment movement of the dosing mechanism or the dosing element is prevented in a starting position of the lock and is possible only after a movement or displacement of the lock or the holding element. An injection device used in conjunction with a two-chamber ampoule is encompassed, as is a method for preparing the injection device for dispensing a substance wherein the ampoule is introduced into the injection device and a lock is released when the ampoule has been introduced far enough to appropriately mix the substances in the two chambers, whereupon the mixed substances can be dispensed from the ampoule. [0007] In one embodiment, the invention comprises a blocking element for a dosing mechanism of an injection device with at least one holding element that can interact with the dosing mechanism, or with a dosing element of the dosing mechanism, in such a way that an adjustment movement of the dosing mechanism or of the dosing element can be prevented in a starting position of the blocking element and is permitted only after a movement or displacement of the blocking element or of the holding element. The invention also relates to a method for preparing an injection device for dispensing a substance from an ampoule or two-chamber ampoule, wherein the ampoule or two-chamber ampoule is introduced, e.g. screwed, into the injection device, and the blocking or anti-rotational locking of the dosing or adjusting element or a lifting element of the injection device is only released when the ampoule has been introduced so far into the injection device that a substance can be dispensed from the ampoule in a defined or dosed manner, and/or that the substances contained in the two-chamber ampoule are appropriately or properly, e.g. completely, mixed. [0008] In one embodiment, the lock element has at least one displaceable, e.g. flexible, retaining element, which is able to co-operate with the dose setting mechanism or dose setting element of the injection device so that a priming, dose setting, or setting movement or operation can be prevented and/or precluded. In some embodiments, the movement or operation, such as a rotating or sliding movement or an extraction movement of the dose setting element is prevented when the lock element is in an initial position due to a catch connection to the lock element, and is not triggered or initiated until the at least one retaining element has been displaced or moved, for example by a sliding movement of the lock element caused by or after introducing an ampoule. [0009] In some embodiments, a lock element in accordance with the present invention prevents a dose setting mechanism and/or a setting or dose setting element from being operated to set a dose or prime an injection device before an ampoule is loaded in the injection device. In some embodiments, the ampoule may be a two-chamber ampoule which makes contact with the lock element, and it and/or the lock element has been pushed into or moved relative to the injection device by a pre-defined distance, e.g. 2 mm, thereby releasing the dose setting mechanism, for example by moving a retaining element engaging the dose setting mechanism. [0010] In some embodiments, the lock element is in the form of a ring and has a contact surface for contacting an ampoule or ampoule sleeve, so that an ampoule fully or almost fully inserted or screwed into the injection device moves into contact with the lock element and drives or moves it relative to the injection device or relative to the setting mechanism on the last part of the distance of the pushing-in or screwing-in movement. In some embodiments, the at least one retaining element is biased radially inwardly or radially outwardly, and locates or is receiveable in a recess or groove of a dose setting element or a dose setting device to prevent a rotating movement or extraction of the dose setting element, e.g. the lock element is fitted in or with the injection device to afford an anti-rotation lock. In some embodiments, two or more retaining elements are provided, for example two retaining elements opposite one another on an annular lock element, which can be biased radially inwardly and locate in, lodge in or be connected to the dose setting mechanism or a dose setting element in an initial position when the ampoule has not yet been fully inserted, and/or are not pushed radially outwardly to release the dose setting element or dose setting mechanism until an ampoule has been introduced. [0011] Another aspect of the present invention relates to a dose setting mechanism for an injection device, wherein the does setting mechanism has a lock element of the type described above and at least one dose setting element, e.g. a rotating knob or a rotating sleeve. In some preferred embodiments, the dose setting element has at least one retaining or locating element or a recess, such as a groove, with which the at least one retaining element of the lock element co-operates, i.e. in which it locates. The lock element is mounted so that it is able to slide, e.g. axially, relative to the dose setting element toward, through or out of it. The at least one retaining element of the lock element may be such that during or after a sliding movement of the lock element relative to the dose setting element, the retaining element or elements is or are moved or pushed by a ramp or inclined surface that does not slide with the lock element so that a coupling no longer exists between the lock element and the dose setting mechanism or dose setting element, which means that the dose setting element or dose setting mechanism can be operated and rotated or pulled out of the injection device to set a dose or prime the injection device. [0012] The expression “retaining element” as used herein is intended to encompass and/or mean any element, feature, structure or the like, e.g. a recess or bore, that enables a coupling or connection, e.g., an anti-rotation lock, with another element. For example, a displaceable or flexible retaining element biased radially inwardly or outwardly may be provided on the lock element and/or on the dose setting element or dose setting mechanism, which co-operates with another retaining element or a cut-out or a recess or groove on the respective co-operating element, for example the dose setting element or dose setting mechanism or lock element, to establish a releasable coupling between the lock element and the dose setting element or dose setting mechanism. In some preferred embodiments, this coupling is then released when an ampoule is or has been introduced into the injection device to a pre-defined length, e.g. by a sliding movement of at least one retaining element caused by the ampoule being introduced and guided by a guide profile. [0013] In some embodiments, the present invention relates to an injection device with a dose setting mechanism of the type described above and an ampoule insertion part such as an ampoule sleeve or, alternatively, an ampoule body, able to co-operate with the lock element, the dose setting element or dose setting mechanism as it is inserted. This is accomplished, for example, by moving into contact with the lock element or dose setting mechanism and causes the dose setting mechanism or dose setting element to be released during the movement or sliding action of the dose setting mechanism or lock element relative to the injection device or to a housing of the injection device caused by the movement of the ampoule as it is being inserted. In this respect, the lock element may also be part of the dose setting mechanism. [0014] In some preferred embodiments, the injection device has a guide element, such as a ramp or a profile, extending at an angle with respect to the axial direction. The guide element is disposed relative to a retaining element of the lock element or dose setting mechanism so that an axial sliding movement of the lock element or dose setting mechanism relative to the injection device causes at least one retaining element to be moved by the guide, such that the engagement between the lock element and the dose setting element or dose setting mechanism is released. [0015] In some preferred embodiments, a flange is provided on the injection device. The flange pushes against a stopper of the ampoule, e.g. a two-chamber ampoule, when it is introduced or screwed in. This causes the stopper to be pushed into the ampoule as the ampoule is being screwed into the injection device so that the substances contained in the two-chamber ampoule are mixed. [0016] Another embodiment of the present invention relates to a method of preparing an injection device for dispensing a substance from a two-chamber ampoule, wherein the two-chamber ampoule is introduced into the injection device, e.g. screwed in, and a lock of a setting element or priming element of the injection device is released when the ampoule has been introduced far enough into the injection device that the substances contained in the two-chamber ampoule have been properly mixed. In some embodiments, the lock is an anti-rotation lock. BRIEF DESCRIPTION OF THE DRAWINGS [0017] FIG. 1 is a perspective view illustrating one embodiment of the present invention, a dose setting mechanism with a released lock element; [0018] FIG. 2 is a side view of the dose setting mechanism illustrated in FIG. 1 prior to mixing; [0019] FIG. 2A is a sectional view along line C-C in FIG. 1 ; [0020] FIG. 2B is a detail D from FIG. 2A ; [0021] FIG. 3 shows the dose setting mechanism illustrated in FIG. 2 once the two-chamber ampoule has been fully screwed in and mixed; [0022] FIG. 3A is a sectional view along line A-A in FIG. 3 ; [0023] FIG. 3B illustrates detail B from FIG. 3A ; [0024] FIG. 4 is a plan view of an embodiment of an injection device in accordance with the present invention with the mechanism locked; [0025] FIG. 4A is a sectional view along line A-A in FIG. 4 ; [0026] FIG. 5 shows the injection device illustrated in FIG. 4 with the mechanism released; and [0027] FIG. 5A is a sectional view along line B-B in FIG. 5 . DETAILED DESCRIPTION [0028] With regard to fastening, mounting, attaching or connecting components of the present invention, unless specifically described as otherwise, conventional mechanical fasteners and methods may be used. Other appropriate fastening or attachment methods include adhesives, welding and soldering, the latter particularly with regard to the electrical system of the invention, if any. In embodiments with electrical features or components, suitable electrical components and circuitry, wires, wireless components, chips, boards, microprocessors, inputs, outputs, displays, control components, etc. may be used. Generally, unless otherwise indicated, the materials for making the invention and/or its components may be selected from appropriate materials such as metal, metallic alloys, ceramics, plastics, etc. [0029] FIG. 1 is a perspective view illustrating one embodiment of a dose setting mechanism in accordance with the present invention which can be inserted in an injection device. A lock sleeve disposed at least in the front or distal part inside the housing of the injection device when the dose setting mechanism is inserted has an orifice 8 a in which a retaining element 1 a of the locking ring 1 , which is biased radially inwardly and serves as the lock element, locates once the ampoule 5 has been screwed in. [0030] In the initial position illustrated in FIG. 2 , the locking ring 1 is mounted so that it can not rotate relative to the injection device or the housing of the injection device by an orifice in the housing, in which an element of the locking ring 1 such as a retaining element 1 a is received. Thus, the dose setting sleeve 2 is mounted in the injection device so that it can not rotate due to the retaining element 1 a locating in the orifice or groove 2 a of the dose setting sleeve 2 . The locking ring 1 is biased in the distal (or forward) direction of the injection device by a spring force, for example. [0031] FIG. 2 is a side view showing the dose setting mechanism illustrated in FIG. 1 , with the retaining element 1 a of the locking ring 1 lying relative to the groove 8 a of the sleeve 8 so that there is still a distance d to the proximal end of the groove 8 a shown on the right-hand side of FIG. 2 . [0032] FIG. 2A is a view in section along line C-C indicated in FIG. 2 , showing how the retaining element 1 a , biased radially inwardly, is received in a groove 2 a of the dose setting sleeve 2 and thus blocks any rotating movement of the dose setting sleeve 2 relative to the housing 3 of the injection device. When an ampoule 5 inserted in an ampoule sleeve 4 is screwed into the injection device to push the rear or proximal stopper 5 a of the ampoule into the two-chamber ampoule 5 by the flange 6 mounted on the threaded rod 7 of the injection device to enable mixing in the two-chamber ampoule 5 . The proximal end of the ampoule sleeve 4 illustrated on the right-hand side of FIG. 2A moves into contact with the front face lb of the locking ring 1 when the ampoule sleeve 4 with the ampoule 5 in it has been screwed far enough into the injection device for the flange 6 to have been pushed sufficiently far into the ampoule 5 to have caused complete or almost complete mixing of the two-chamber ampoule. When the ampoule sleeve 4 is screwed farther into the injection device, the locking ring 1 is pushed to the right in FIG. 2A , in other words in the proximal direction, due to the contact of the proximal end of the ampoule sleeve 4 with the contact face lb. This causes the guide profile 1 c provided in the locking ring 1 to move into contact with the ramp 3 a which is not able to slide relative to the injection device. The sliding movement of the locking ring 1 causes the retaining element 1 a to be pushed outwardly against the inwardly directed biasing force of the retaining element 1 a , as illustrated in detail B of FIG. 3B , thereby releasing the retaining element 1 a from its position located in the groove 2 a of the dose setting sleeve 2 so that the dose setting sleeve 2 is no longer prevented from rotating relative to the injection device. [0033] FIGS. 3 and 3A illustrate the status of the dose setting mechanism after the locking ring 1 has moved slightly in the proximal direction by the distance d to unlock the dose setting sleeve 2 . [0034] After the ampoule 5 has been fully mixed and the anti-rotation lock 1 a , 2 a of the dose setting sleeve 2 has been released, the dose setting sleeve 2 can be rotated by a user to set a dose or prime the injection device, so that a dose is dispensed from the ampoule 5 during an injection. [0035] The setting mechanism is therefore mechanically locked by the two fork-shaped lock pawls 1 a of the locking ring, which extend through co-operating recesses 2 a of the rotating or dose setting sleeve 2 . Since the pen is primed by rotating the rotating ring 2 , this is now not possible because the rotation is prevented by the locking ring 1 . [0036] To unlock the mechanism, the ampoule sleeve 4 , which was screwed into the dose setting or setting mechanism to mix the two-chamber ampoule 5 , is screwed in. On the last approximately 2 mm of the screwing-in movement, the locking ring 1 is moved from the locked position into the unlocked position by the ampoule sleeve 4 . To this end, the locking ring 1 has inclined surfaces on the inner faces of the two fork-shaped lock pawls 1 a which complement the inclined surfaces 3 a of the guide sleeve or housing. As a result, the two lock pawls 1 a are pushed out and thus release the dose setting sleeve 2 or mechanism. [0037] The retaining element 1 a or locking ring 1 is designed so that it is pushed in the proximal direction by the ampoule sleeve 4 , which is screwed into the pen when the ampoule 5 is screwed in to mix the substance. A ramp or slide surface 3 a, provided on the housing of the injection device, causes the retaining element 1 a of the locking ring 1 , which is moved relative to the ramp 3 a by the ampoule sleeve 4 , to be pushed radially outwardly and thus release the anti-rotation lock of the dose setting sleeve 2 . Consequently, once the ampoule sleeve 4 has been fully pushed in, a dose can be set by rotating the dose setting sleeve 2 . This ensures that the dose setting sleeve 2 can not be rotated until the ampoule sleeve 4 has been fully screwed into the pen, in other words far enough for the ampoule sleeve 4 to hit the locking ring 1 and push it by a farther distance into the injection device. [0038] FIG. 4 is a plan view showing an injection device with the mechanism locked, as illustrated along section A-A indicated in FIG. 4A . As may be seen from FIG. 4A , the retaining element 1 a , which need not necessarily be mounted on a locking ring, is urged radially inwardly and locates or lodges in a groove 2 a of the dose setting sleeve 2 , thus blocking or locking any rotating movement of the dose setting sleeve 2 relative to the housing 3 of the injection device. The ampoule 5 inserted in the ampoule sleeve 4 can be screwed into the injection device, as illustrated in FIGS. 5 and 5A . As a result, the guide profile 1 c moves into contact with the ramp 3 a , which is not able to move relative to the injection device and is pushed outwardly against the biasing action of the retaining element 1 a due to the movement of the retaining element 1 a , once the proximal end of the ampoule sleeve 4 has reached the contact surface 1 b as may be seen from FIG. 5A . As a result, the engagement of the retaining element 1 a in the groove 2 a of the dose setting sleeve 2 is released so that the dose setting sleeve 2 is no longer prevented from rotating relative to the injection device. In the case of the injection device illustrated in FIG. 5A , the ampoule has therefore been completely or almost completely inserted and a dose setting or setting movement can take place because the dose setting sleeve 2 has been released by outward movement of the retaining element 1 a. [0039] Embodiments of the present invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms and steps disclosed. The embodiments were chosen and described to provide the best illustration of the principles of the invention and the practical application thereof, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.

A lock for a dosing mechanism of an injection device, the lock including at least one holding element that interacts with the dosing mechanism, or with a dosing element of the dosing mechanism, whereby an adjustment movement of the dosing mechanism or the dosing element is prevented in a starting position of the lock and is possible only after a movement or displacement of the lock or the holding element. An injection device used in conjunction with a two-chamber ampoule is encompassed, as is a method for preparing the injection device for dispensing a substance wherein the ampoule is introduced into the injection device and a lock is released when the ampoule has been introduced far enough to appropriately mix the substances in the two chambers, whereupon the mixed substances can be dispensed from the ampoule.

FIELD OF THE INVENTION The present invention relates to a vacuum cleaner; and, more particularly, to a cover locking/releasing structure and a cover hinge-coupling structure of a vacuum cleaner wherein a suction inlet is formed at a main body thereof. BACKGROUND OF THE INVENTION In general, a vacuum cleaner suctions dust particles on a floor by using a suction force of a fan rotated by a motor installed inside the vacuum cleaner, entraps the dust particles in a dust bag disposed in front of the fan while releasing dust-free air to the outside of the vacuum cleaner. FIG. 1 shows a conventional vacuum cleaner including a main body 110 and a cover 120 openably attached to the main body 110 . The cover 120 is hinge-coupled to an upper portion of the main body 100 , and an air suction tube 130 is connected to the cover 120 . Further, the main body 110 of the vacuum cleaner includes a motor chamber (not shown) accommodating therein a driving motor (not shown) and a dust chamber 114 for accommodating therein, e.g., a dust bag 150 or a cyclonic dust collection device for collecting dust particles contained in air suctioned through the air inlet tube 130 . When the dust bag 114 is filled with dust particles, it should be replaced or emptied. For the purpose, the cover 120 covering the dust chamber 114 is opened approximately upright, as shown in FIG. 1 , and the dust bag 150 is removed from the dust chamber 114 . However, in the conventional vacuum cleaner, since the air inlet tube 130 is connected to a suction inlet provided in the cover 120 , a connection structure of the cover 120 and the main body 110 becomes complicated due to wirings for connecting electrical components such as a switch provided at the air inlet tube 130 to the main body 110 . Furthermore, when a user attempts to remove the dust bag 150 from the dust chamber 114 with his hands off the cover 120 after the cover 120 is opened as shown in FIG. 1 , the cover 120 is often closed due to its weight, which causes an inconvenience to the user. Moreover, in case the user opens the cover 120 with an excessively great force, the cover 120 may be collided with or separated from the main body 110 . SUMMARY OF THE INVENTION It is, therefore, an object of the present invention to provide a vacuum cleaner having a simple locking/releasing structure of a cover and a main body by providing a suction inlet at the main body. It is another object of the present invention to provide a vacuum cleaner having a cover hinge-coupling structure which allows the cover to be rotated about two different hinge axes, while preventing the cover from being unintentionally closed by itself. In accordance with an aspect of the present invention, there is provided a vacuum cleaner including: a suction inlet formed at a main body; a cover hinge-coupled to the main body to cover a dust collection chamber defined in the main body; and a locking unit for releasably locking the cover, the locking unit being disposed around the suction inlet. Preferably, the locking unit includes a pair of locking members disposed at two opposite sides of the suction inlet and a resilient member disposed between the locking members to bias the locking members outward, each locking member having an engagement protrusion projected outward; the cover includes an outer portion and an engagement portion each of which has an approximate U-shape in section, the engagement portion having opposite button portions projected through the outer portion and opposite pressing portions extended from the button portions inside the outer portion, the outer portion having opposite projecting portions which are projected inward from the outer portion to be engaged with the respective engagement protrusions of the locking members. In accordance with an another aspect of the present invention, there is provided a vacuum cleaner including: a main body in which a dust collection chamber is defined; a cover for covering the dust collection chamber; and a pivot link for rotatably connecting the cover and the main body, wherein the cover and the main body are rotatable about different two hinge axes. Preferably, the pivot link includes a cover coupling portion and a main body coupling portion extended from the cover coupling portion in an approximate L-shape; the cover is hinge-coupled to the cover coupling portion of the pivot link to be rotatable about one of the hinge axes; and the main body coupling portion of the pivot link is hinge-coupled to the main body to be rotatable about the other hinge axis. Preferably, the main body coupling portion has a hinge shaft provided at an end portion thereof, the hinge shaft of the main body coupling portion being hinge-coupled to a coupling recess provided at the main body. Preferably, the coupling recess of the main body has wave-shape side surfaces such that side surfaces of the main body coupling portion of the pivot link are friction coupled to the wave-shape side surfaces of the coupling recess. In accordance with a further another aspect of the present invention, there is provided a vacuum cleaner including: a suction inlet provided at a main body; a cover hinge-coupled to the main body to cover a dust collection chamber included in the main body; a locking unit for releasably locking the cover, the locking unit being disposed around the suction inlet; and a pivot link for rotatably connecting the cover and the main body, wherein the cover and the main body are rotatable about different two hinge axes. BRIEF DESCRIPTION OF THE DRAWINGS The above and other objects and features of the present invention will become apparent from the following description of preferred embodiments given in conjunction with the accompanying drawings, in which: FIG. 1 is a perspective view of a conventional vacuum cleaner with its cover opened; FIG. 2A sets forth a perspective view of a vacuum cleaner in accordance with the present invention, wherein a pivot link is shown separately; FIG. 2B is a partially cut-away perspective view of a locking member and a cover locked together; FIG. 3 provides a cross sectional view of a cover locking/releasing structure in accordance with the present invention; FIG. 4A shows a cover and a main body hinge-coupled to each other; and FIG. 4B depicts a partial enlarged view of a portion in FIG. 4A . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, preferred embodiments of the present invention will be described with reference to FIGS. 2 to 4B . Referring to FIG. 2A , there is illustrated a vacuum cleaner in accordance with the present invention, wherein a cover 5 of the vacuum cleaner is opened and a pivot link 20 for connecting a main body 1 and the cover 5 of the vacuum cleaner is shown separately. A suction inlet 2 to which an air suction tube (not shown) is connected is disposed in a front region of the main body 1 of the vacuum cleaner, and a dust collection chamber 4 is provided behind the suction inlet 2 in order to accommodate therein a dust bag or a cyclonic dust collection device. The cover 5 is hinge-coupled to the main body 1 via the pivot link 20 to cover the dust collection chamber 4 . The dust bag or the cyclonic dust collection device can be removed from the main body 1 after opening the cover 5 , as shown in FIG. 2A . Further, locking members 30 are installed at outer peripheral portions of the suction inlet 2 to keep the cover 5 locked in position while covering the dust collection chamber 4 . Hereinafter, structures of the cover 5 and the locking members 30 and their locking/releasing operations will be described with reference to FIGS. 2B to 3 . FIG. 2B is a partially cut-away perspective view of the locking member 30 and the cover 5 locked together and FIG. 3 sets forth a cross sectional view showing a locked state of the cover 5 and the locking members 30 . The locking members 30 are disposed at two opposite sides of the suction inlet 2 and each locking member 30 has an engagement protrusion 32 at an approximately central portion thereof. The upper end of each locking member 30 is supported by a locking member support 30 A such that it is pivotable about the upper end thereof, and a resilient member such as a compression spring 18 is interposed between the lower ends of both locking members 30 . The compression spring 18 serves to bias the locking members 30 outward against stoppers 30 B, respectively. The cover 5 includes a sealing portion 6 brought into contact with the outer peripheral surface of the locking member support 30 A; an outer portion 5 A having protruding portions 5 A′ projected inward from two opposite lower ends thereof; and an engagement member 10 interposed between the sealing portion 6 and the outer portion 5 A. The sealing portion 6 , the outer portion 5 A and the engagement member 10 have an approximate U-shape in section. The engagement member 10 has at both sides thereof button portions 14 projected outward through openings of the outer portion 5 A and pressing portions 12 extended downward from the button portions 14 to be located inside the outer portion 5 A. In case the cover 5 is closed to cover the dust collection chamber 4 , the protruding portions 5 A′ of the outer portion 5 A serve to urge the respective engagement protrusions 32 of the locking members 30 , whereby the engagement members 30 are inwardly moved against a bias force of the compression spring 18 . Then, the protruding portions 5 A′ at the outer portion 5 A of the cover 5 are moved downward beyond the engagement protrusions 32 to contact the stoppers 30 B located below the engagement protrusions 30 . At that time, the locking members 30 are moved outward again by the bias force of the compression spring 18 , so that the engagement protrusions 32 are engaged with the respective protruding portions 5 A′ to prevent the cover 5 from being lifted. By such a locking mechanism, the cover 5 is locked by the locking members 30 . In case of lifting the cover 5 to open the dust collection chamber 4 , when a user pushes the button portions 14 which are protruded outwardly through the outer portion 5 A of the case 5 , the pressing portions 12 integrated with the respective button portions 14 are moved inward to press the locking members 30 , respectively. At that time, the locking members 30 are moved inward against the bias force of the compression spring 18 , the engagement of the engagement protrusions 32 and the protruding portions 5 A′ is released, allowing the cover 5 to be movable in an upward direction. In this state, when the user lifts the cover 5 upward, the dust collection chamber 4 is opened. A connection structure of the cover 5 and the main body 1 of the vacuum cleaner in accordance with the present invention will now be described with reference to FIGS. 4A and 4B . FIG. 4A is a partial perspective view of a coupling portion of the cover 5 and the main body 1 of the vacuum cleaner and FIG. 4B provides a partial enlarged view thereof. The cover 5 is hinge-coupled to cover hinge shafts 22 provided at two opposite upper ends of a cover coupling portion 20 A of the approximately L-shaped pivot link 20 (see FIG. 2A ). Main body coupling portions 20 B are extended from the cover coupling portion 20 A in an approximate L-shape. Further, a main body hinge shaft 24 is provided at an end portion of each of the main body coupling portions 20 B. The main body hinge shafts 24 are hinge-coupled to coupling recesses 15 formed at the main body 1 , respectively. Two opposite side surfaces of each of the coupling recesses of the main body 1 are formed in a wave-shape. By allowing both side surfaces of each of the main body coupling portions 20 B to be friction coupled to the wave-shaped surfaces of the corresponding coupling recess 15 , the cover 5 is prevented from being unintentionally closed due to its weight in an open mode. In case of lifting the cover 5 to open the dust collection chamber 4 , the cover 5 is pivoted by the combination of a rotation of the cover 5 about the cover hinge shafts 22 of the cover coupling portion 20 A and a rotation of the main body coupling portions 20 B about the main body hinge shafts 24 . For example, the cover 5 is completely opened in such a way that the cover 5 is rotated about the cover hinge shafts 22 of the cover coupling portion 20 A of the pivot link 20 while or after the pivot link 20 is rotated about the cover hinge shafts 22 of the cover coupling portion 20 A. In this way, the cover 5 is opened in multi-stages by two different hinge axes of the hinge shafts 22 and 24 . As described above, according to the present invention, there is provided an inventive cover locking/releasing structure and a cover hinge-coupling structure. The locking/releasing structure of the main body and the cover is simplified, and the cover can be prevented from being unintentionally closed due to its weight in an open mode. While the invention has been shown and described with respect to the preferred embodiment, it will be understood by those skilled in the art that various changes and modification may be made without departing from the spirit and scope of the present invention as defined in the following claims.

A vacuum cleaner includes a suction inlet provided at a main body and a cover hinge-coupled to the main body to cover a dust collection chamber included in the main body. A locking unit is disposed around the suction inlet in order to releasably lock the cover. Further, the vacuum cleaner may include a pivot link for rotatably connecting the cover and the main body. With the pivot link, the cover and the main body are rotatable about two different hinge axes.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of U. S. Provisional Application No. 61/095,194, filed Sep. 8, 2008. FIELD OF THE INVENTION [0002] The present invention is directed to non-aerosol shaving products that employ technology to provide both heat and lather during use. BACKGROUND OF THE INVENTION [0003] The use of reactive chemistry to create self-heating personal care compositions is known. The general approach involves employing a multi-chambered package with one chamber holding an oxidative phase and another chamber holding a reductive phase. Dispensing and mixing the two phases results in heat development through a chemical reaction between the oxidative phase and reductive phase. [0004] Shaving compositions is one art area that has experienced significant development of self-heating chemistries. The sensation of warmth on skin prior to and/or during shaving can be perceived as highly beneficial by users of exposed blade razors. Consumers believe that heat can accomplish one or more of the following: open pores, soften skin and beard hair, provide a closer and more comfortable shave, reduce irritation, and leave skin refreshed and protected. [0005] One prior self-heating shaving composition featured a non-aerosol formulation that employed separate non-ionic emulsion bases containing a reductant and oxidant, respectively. By virtue of the non-ionic base and no gas being involved, the formulation was essentially a non-lathering shave product. Despite the benefits of heat associated with the formulation, the majority of consumers still prefer lathering shave preps. Thus, developing a shaving product that combines the sensation of warmth and perceivable lather would be advantageous. The attempts to date however have not been optimal. For example, one prior attempt has employed conventional soap-based formulas pressurized in an aerosol package containing a volatile hydrocarbon propellant. But several disadvantages are realized with this approach, including VOC concern, fast heat dissipation, harshness of the soap base, and complicated/expensive aerosol packaging. Another prior attempt involved incorporating volatile hydrocarbons or fluorinated hydrocarbons in water-base emulsions which would volatilize upon spreading the composition onto one's skin. These formulations proved however to be highly unstable and prone to losing hydrocarbons during storage. [0006] Accordingly, there is room for improvement in the development of a shaving product that adequately provides both heat and sustained lather. SUMMARY OF THE INVENTION [0007] The present invention is directed to self-heating shaving products that feature lather produced by nascent gas release in situ when mixing reductant and oxidant phases. The shaving products employ either a multi-chambered container or two separate containers that hold and dispense a first composition and a second composition. The first composition comprises a reducing agent and a carbon dioxide source, and the second composition comprises an oxidizing agent. The first composition is preferably formulated at a pH of from about 8.5 to about 10.5 to ensure stability of the carbon dioxide source. And the second composition is preferably formulated at a pH of from about 2.8 to about 3.8. When the first and second compositions are combined an exothermic redox reaction occurs to produce heat. Another result of the redox reaction employed in this invention is the formation of acid. As the reaction is completed, the high pH associated with the first composition drops, which in turn drives the release of carbon dioxide to produce the initial lather/foam. To sustain and/or accentuate the initial lather, systems comprising surfactants, opacifiers, and/or polymers are employed. BRIEF DESCRIPTION OF THE DRAWING [0008] The FIGURE is a chart illustrating lather dynamics (first 5 minutes) with different reductant formulations. DETAILED DESCRIPTION OF THE INVENTION [0009] The present invention may be understood more readily by reference to the following detailed description of illustrative and preferred embodiments. It is to be understood that the scope of the claims is not limited to the specific ingredients, methods, conditions, devices, or parameters described herein, and that the terminology used herein is not intended to be limiting of the claimed invention. Also, as used in the specification, including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. When a range of values is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent basis “about,” it will be understood that the particular values form another embodiment. All ranges are inclusive and combinable. [0010] All percentages and ratios used herein are by weight of the first, second or mixed composition, and all measurements made are at 25° C., unless otherwise designated. [0011] The self-heating shaving products comprise a first composition containing a reducing agent and second composition containing an oxidizing agent, which when combined into a mixed composition generate heat from the exothermic redox reaction. The first composition further comprises a source for generating carbon dioxide to foam or lather the mixed composition. The first and second compositions are kept separate from one another prior to use, preferably through employment of a multi-chambered container/dispenser or two separate containers/dispensers. The containers/dispensers employed for the shaving compositions of the present invention do not require a volatile propellant and are preferably not pressurized in any way. Furthermore, prior to being dispensed, the first and second compositions are maintained at substantially atmospheric pressure. [0012] Each of the first and second compositions comprises oil-in-water emulsions that could independently be used as a shaving preparation without significant skin irritation. The oil phase of the respective emulsions can include any desired emollient that is safe for use in topical formulas, is compatible with other ingredients of the compositions, and provides the desired aesthetics. Suitable emollients include mineral oil, petrolatum, squalane/squalene, hydrogenated/unsaturated polyisobutene and mixtures thereof. Exemplary compositions contain from about 0.25% to about 15% of the emollient, from about 0.5% to about 12% of the emollient, or from about 0.75% to about 8% of the emollient. [0013] The first composition comprises a reducing agent. A representative, non-limiting list of suitable reducing agents includes thiosulfate and sulfite compounds, such as sodium sulfite, sodium thiosulfate (e.g., sodium thiosulfate pentahydrate), ammonium thiosulfate, potassium thiosulfate, and thiourea; and compounds with a thiourea backbone, such as 1,5-diethyl-2-thiobarbituric acid or its derivatives, or ascorbic acid. Mixtures of these reducing agents, and other suitable reducing agents, may also be used. In some embodiments, the first composition employs the reducing agent at concentrations from about 2% to about 10%, preferably from about 3% to about 8%, by weight of the first composition. [0014] A carbon dioxide source is also included in the first composition. The carbon dioxide source can be, for example, carbonate or bicarbonate salts of alkaline or alkaline earth metals, such as sodium, potassium, calcium and magnesium carbonates, and sodium and potassium bicarbonates. Mixtures of these materials can be used, as well as other carbon dioxide sources generally known to the skilled artisan. The carbon dioxide source is included in some first composition embodiments at concentration levels of from about 1% to about 10%, from about 2% to about 7%, and from about 3% to about 5%, by weight of the first composition. [0015] The first composition is preferably formulated to a pH of from about 8.5 to about 10.5 to ensure stability of the carbon dioxide source during storage. Materials that can be used to adjust the pH include, for example, sodium and potassium hydroxide, calcium oxide, triethanolamine, and sodium and potassium carbonate. Such pH adjusters can be employed at a level for example of from about 2% to about 8%, or from about 3% to about 5%, by weight of the first composition. [0016] The second composition comprises an oxidizing agent. Suitable oxidizing agents include, but are not limited to, peroxides, such as hydrogen peroxide (typically added as a 35% solution), benzoylperoxide, peroxomonosulfate, peroxodisulfate, urea hydrogen peroxide, and t-butyl peroxide. In some embodiments, the second composition may include from about 2% to about 10% of the oxidizing agent. In certain embodiments, the second composition can include from about 12% to about 16% of an oxidizing agent, such as hydrogen peroxide (35%) (which corresponds to about 4% to about 6% H 2 O 2 active). [0017] The second composition is preferably formulated to a pH of from about 2.8 to about 3.8, or from about 3.0 to about 3.6. The reason for this preferred range is three-fold: 1) to achieve a final pH of from about 5 to about 7 (or from about 6.0 to about 6.8) of the stoichiometric mixture of the first and second compositions whereby heat production and gas release are satisfactory; 2) to enhance storage stability of the oxidizing agent; and 3) to mitigate the potential for skin irritation when dispensing ratios of the first and second compositions are off target. The pH adjusters of the second composition are mineral acids (e.g., phosphoric acid), at a concentration of 0.25% to 1.5%, and preferably 0.75% to 1.0%. Acid can be partially neutralized by employing sodium tetraborate at around 1-2.5%, so that a pH of 3.0 to 3.4 is achieved. Other pH adjusters can be used, including, for example, disodium or dipotassium phosphate, calcium or magnesium oxide or hydroxide. [0018] As noted above, the first and second compositions are kept separate from one another prior to use. The volumes of the first and second compositions are included in separate containers or separate chambers of single containers so that they can be dispensed in appropriate relative amounts to provide a stoichiometric exothermic reaction when mixed. As the redox reaction results in the formation of acid, the high pH associated with the first composition drops, which in turn drives the release of carbon dioxide to produce the initial lather/foam. Lather in some of the embodiments typically starts forming about 5-10 seconds after mixing the first and second compositions, with temperature rising to about 35-40° C. during this time frame. The temperature continues to rise, reaching a maximum temperature of about 50-55° C. within 50-60 seconds after mixing and remains at that level for another 10-20 seconds. The lather/foam volume associated with the mixed composition can increase to greater than 5 times the initial dispensed volume. The lather/foam volume at around one minute after dispensing however is not sustained as the mixed composition is spread onto one's skin because the escaping carbon dioxide is not trapped to a significant extent by the mixed emulsion. The lather/foam volume upon spreading can be ⅓ of the peak volume achieved around one minute after dispensing and mixing the first and second compositions. Applicant however discovered a number of different techniques to sustain lather/foam volume, which are discussed in more detail below. [0019] Particular surfactant systems for each of the first and second compositions is one technique discovered by the Applicant to sustain the carbon dioxide induced lather/foam. Primary surfactants for the first composition include mild non-ionic surfactants free from polyethylene oxides, such as, for example, polyglycerol fatty esters, glycosyl ethers, and sugar esters. Exemplary polyglycerol fatty esters include decaglyceryl dipalmitate, hexaglyceryl myristate, decaglyceryl laurate, hexaglyceryl laurate, and triglyceryl stearate. A representative, non-limiting list of suitable glycosyl ethers includes cetearyl polyglucoside, behenyl polyglucoside, myristyl polyglucoside, and cocoyl polyglucoside. Suitable sugar ester include, but are not limited to, sucrose esters, such as sucrose monostearate and sucrose distearate; and sorbitan esters, such as sorbitan monostearate, sorbitan palmitate, sorbitan oleate, sorbitan sesquioleate, and sorbitan isostearate or esters of mixed structure (e.g., PEG-3 methylglucose distearate). These primary surfactants may be employed at concentration levels of from about 2-8% or 3-5%, by weight of the first composition. [0020] To boost the initial carbon dioxide induced lather/foam, one or more anionic surfactants can be formulated into the first composition in addition to the non-ionic surfactants discussed above. The one or more anionic surfactants are generally included at a total concentration of up to about 5%, by weight of the first composition. Exemplary anionic surfactants include fatty acyl sulfosuccinates, sarcosinates and lactylates. Di-sodium laureth-2 sulfosuccinate, sodium lauroyl sarcosinate and sodium lauroyl lactylate are some of the preferred anionic surfactants. [0021] Exemplary surfactant systems for the second composition include a combination of ethers of fatty alcohols and polyoxyethylene with an ethylene oxide chain from 2 to 100 and fatty alkyl chain from 12 to 24. These surfactants are believed to be stable in the presence of the oxidizing agent, and be able to provide a stable shaving composition with desirable viscosity, aesthetics and rinsing properties. One preferred combination is a blend of derivatives with shorter and longer ethylene oxide chains. In certain embodiments, the second composition may include form about 2% to about 8% (or from about 2% to about 6%) of a non-ionic surfactant. In other embodiments, the second composition may include from about 2% to about 6%, preferably from about 3% to about 5%, of a shorter polyethylene oxide chain length non-ionic surfactants, such as Steareth-2. Additionally, the second composition may include from about 1% to about 4%, preferably from about 1.5% to about 3%, of a long polyethylene oxide chain length non-ionic surfactant, such as Steareth-21. In some embodiments, the second composition can include form about 1% to about 6% of one non-ionic surfactant, and from about 1% to about 6% of another, different non-ionic surfactant. [0022] To stabilize the carbon-dioxide induced foam, Applicant discovered that materials can be employed to increase the viscosity of the liquid surrounding individual bubbles. These materials may include, for example, amphoteric surfactants, such as Cocamidopropyl Betaine or Cocamidopropyl Hydroxysultaine; alkoxylated fatty amides, such as PPG-2 Hydroxyethyl Cocamide, PPG-2 Hydroxyethyl Coco/Isostearamide or PPG-3 Hydroxyethyl Soyamide; or silicone ethers, such as PEG-12 Dimethicone. When employed, these materials are generally included at a level of from about 0.5% to about 3.5%, and preferably from about 1.5% to about 2.0%. [0023] Certain acidic polysaccharides (e.g., xanthan gum, alginates) can be employed to provide a negative charge to help prevent fusion of adjacent foam bubbles by means of electrostatic repulsion. By virtue of its highly pseudoplastic behavior, inclusion of xanthan gum can also increase the integrity of residual film of the mixed composition on one's skin. [0024] Opacity is a desired property of lathering shave preparations since it can help with tracking blade strokes on the skin, and since it provides a confidence level that a protective residual film that exists between the blade and the skin. Using surfactants with long, saturated fatty chains, such as C 16 -C 22 can provide such an opacifying effect. Examples of these types of surfactants include Steareth-2, Steareth-21, Cetearyl Glucoside, Arachidyl Glucoside, Sucrose Stearate and Sucrose Distearate, and PEG-3 Methylglucose Distearate. Imparting an opacifying effect can also be achieved by adding specific substances selected from the group comprising long chain fatty alcohols (e.g., cetearyl, stearyl, arachidyl alcohol); fatty esters (e.g., cetearyl stearate, cetearyl octanoate, cetyl palmitate, stearyl behenate, glyceryl distearate, glycol stearate, glycol distearate, PEG-3 Distearate); hydrocarbon waxes; and metal oxides, such as titanium dioxide, zinc oxide and magnesium oxide alone or in combination with a mica carrier. Other materials that can impart opacity can also be employed. [0025] The rate of carbon dioxide release may also be manipulated to help sustain the lather/foam volume. This can be accomplished by increasing the pH of the mixed composition to a level of from about 6.2 to about 6.8. Increasing the level of alkaline (e.g., triethanolamine) or buffering salts (e.g., bicarbonates) can result in a higher mixed composition pH. [0026] Bulking materials can be employed to further improve quality of the foam and provide more comfortable shaving. A representative, non-limiting list of suitable bulking materials includes clays, such as sodium potassium aluminum silicate; modified polysaccharides, such as hydroxypropyl starch phosphate and aluminum starch octenyl succinate. By way of example only, the optional bulking materials can be included at a concentration of level of 0.5-3% or 1-2%. [0027] Several other optional ingredients can be included in one or both of the first composition and the second composition. For example, film-forming materials can be used to impart lubricity. Suitable film-forming materials include, but are not limited to, acrylamide/sodium acrylate/acrylic acid copolymers, sodium polyacrylate, chitosan derivatives (e.g., chitosan lactate or glycolate), associative thickeners (e.g., Polyether-1), natural waxes (e.g., beeswax, candelilla wax hydrocarbons and canauba acid wax), hydrocarbon polymers (e.g., petrolatum, mineral oil, squalane or polyisobutene), and hydrogenated vegetable oils (e.g., hydrogenated castor oil or hydrogenated olive oil). Such film-forming materials can be included at 1-10%. [0028] To obtain certain targeted heat profiles, it may be advantageous to include a catalyst in the shaving composition. The catalyst is selected to catalyze the exothermic reaction, without deleterious effects on the skin or on the properties of the shave cream. The catalyst is generally included in the first composition that includes the reducing agent. Suitable catalysts for the exothermic reaction include sodium molybdate (e.g., sodium molybdate dihydrate), potassium molybdate, ammonium molybdate, sodium tungstate, potassium tungstate, and mixtures thereof. The first composition generally includes 0.1% to about 1.5%, preferably about 0.2% to about 1.0%, of the catalyst. [0029] If the exothermic reaction generates an acid, as the reaction of the oxidizing and reducing agents discussed above will generally do, it is preferred that the first composition also include a neutralizing agent (a neutralizer). The neutralizing agent is selected and provided in a sufficient amount to neutralize enough of the acid so that the exothermic reaction is complete and the shaving composition will not irritate the user's skin. Preferably, substantially all of the acid is neutralized. Suitable neutralizing agents include, for example, triethanolamine, oxides (e.g., metal oxides), hydroxides (e.g., metal hydroxides), and metal carbonates, such as carbonates of alkaline metals (e.g., sodium, potassium), alkaline-earth metals (e.g., magnesium, barium), or transition metals (e.g., zinc). For example, the neutralizing agent may include calcium oxide, potassium hydroxide, sodium hydroxide, potassium bicarbonate, sodium bicarbonate or aluminum hydroxycarbonate. In some embodiments, the shaving composition (preferably the first composition) can include from about 0.5% to about 10% of such a neutralizer. For example, the first composition can include about 1% calcium oxide or about 4% triethanolamine. [0030] The shaving composition may also contain other optional ingredients, including, for example, fragrances, colorants, skin-soothing agents, beard wetting agents, skin conditioning (e.g., exfoliating, moisturizing) agents (e.g., vitamin precursors and derivatives such as, for example, vitamins A, C and E, aloe, allantoin, panthenol, alpha-hydroxy acids, beta-hydroxy acids, phospholipids, triglycerides, botanical oils, amino acids), humectants (e.g., glycerin, sorbitol, pentylene glycol), phosphorus lipids (used, e.g., to encapsulate skin conditioning agents), antioxidants, preservatives, and other such ingredients. It may be desirable to include colorants in one or both of the first and second composition so that the compositions have different appearances. The contrast in appearance can help a user to mix the two compositions together upon dispensing so that an optimal level of heat and lather can be generated prior to and during use of the shaving composition. EXAMPLES [0031] The following examples further describe and demonstrate embodiments within the scope of the present invention. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present invention as many variations thereof are possible without departing from the spirit and scope of the invention. [0000] First Composition Examples Comprising Reducing Agent (values by weight %) Ingredients 1 2 3 4 5 6 7 8 Cetearyl Glucoside 0.5 0.8 1.0 1.0 Sucrose Stearate 1.5 2.0 2.0 2.0 1.5 1.5 1.5 1.5 Decaglyceryl-6 3.0 3.0 3.0 2.0 Palmitate PPG-2 Hydoxyethyl 1.5 1.5 2.0 1.5 2.0 2.0 Coco/Isostearamide Cocamidopropyl Betaine 3.0 2.0 Sodium Lauroyl Lactylate 1.5 Di-sodium Laureth-2 3.0 2.0 3.0 3.0 3.0 Sulfosuccinate Sodium Myristoyl 3.0 Sarcosinate Cetearyl Alcohol 2.4 4.0 4.0 4.0 3.0 4.5 4.5 4.5 Microcrystalline Wax 1.0 Petrolatum 2.0 Hydrogenated Castor Oil 1.5 1.5 1.5 1.0 1.5 1.5 1.5 Polyisobutene & 1.0 1.0 1.5 1.5 1.0 1.0 0.5 Polysorbate-20 & Polyacrylate-13 Polyether-1 0.5 Xanthan Gum 0.4 0.5 0.5 Propyleneglycol 0.5 1.0 0.8 Alginate Hydropropyl Starch Phosphate 2.0 1.5 0.8 0.8 1.5 1.5 Sodium Thiosulfate 6.5 6.5 6.5 6.5 6.5 6.5 6.5 6.5 Sodium Molybdate 0.7 0.7 0.7 0.7 0.7 0.7 0.7 0.7 Triethanolamine 4.0 3.0 6.0 4.0 5.0 4.0 4.0 4.0 Sodium Bicarbonate 3.0 3.0 4.0 Potassium Bicarbonate 3.0 3.0 3.0 2.0 3.0 Titanium Dioxide 0.3 0.4 0.4 Titanium Dioxide and Mica 2.0 Perfume 2.0 2.0 2.0 2.0 2.0 1.5 2.0 2.0 Dye Solution, 1% 0.6 0.4 0.3 0.3 0.2 0.05 0.05 Water Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. Q.S. The above first composition examples can be made as follows: Dissolve the water-soluble components of the aqueous phase in water with adequate stirring and bring solution to 80° C. Add hydrophobic materials, such as the fatty alcohols, waxes, hydrocarbons, oils, and co-surfactants to the aqueous solution while continuing to stir. Heat the solution up to 85° C., add the non-ionic emulsifier, and then agitate at an increased speed for about 20 minutes. Cool and continue to stir. Add the neutralizer and anionic surfactant. Homogenize the batch at 68-70° C. using immersion or external homogenizer. Add the reducing and catalyst salts at 55-58° C. The polymer/thickener if needed can then be added and mixed in thoroughly. Add the carbon dioxide source to the batch when the batch is at a temperature below 45° C. Add fragrance and dye at 40° C. Homogenize the batch again for 1½ to 2 minutes to create a smooth cream consistency, having a target final viscosity of 35,000-65,000 cst using an RVT spindle #6 at 1 minute and 10 rpm. [0000] Second Composition Examples Comprising Oxidizing Agent (values by weight %) Ingredients 1 2 3 4 5 Steareth-2 4.2 4.2 4.6 4.2 4.2 Steareth-21 1.8 1.8 2.0 1.8 1.8 Cetearyl Alcohol 2.4 2.8 2.7 2.4 3.0 Microcrystalline Wax 1.0 Polyisobutene 2.9 Petrolatum 2.0 Hydrogenated Castor Oil 2.9 2.4 Beeswax 2.0 Polyisobutene & Polysorbate-20 & 1.0 0.5 Polyacrylate-13 Polyethylene & PTFE 0.5 Titanium Dioxide & Mica 2.0 Phosphoric Acid 1.12 1.12 Sodium Borate 1.8 1.8 Hydrogen Peroxide 4.0 4.0 4.0 4.0 4.0 Dye Solution, 1% 0.4 Water Q.S. Q.S. Q.S. Q.S. Q.S. The above second composition examples can be made as follows: Dissolve water-soluble materials in water to create aqueous phase and heat to 80° C. The oil soluble materials are then added with agitation. Add the non-ionic emulsifier with increased agitation and mix for 20 minutes at 85° C. Cool the mixture to 65° C. and homogenize briefly. Next, add the pH adjuster/buffering agent and then the phosphoric acid. Cool mixture to 40-42° C. and then add the hydrogen peroxide. The polymer/thickener, if one is desired, can then be added. Homogenize the final mixture at 38-40° C. to a smooth cream consistency, having a target final viscosity of 35,000-55,000 cst using an RVT spindle #6 at 1 minute and 10 rpm. [0032] Three samples of first and second compositions, as described herein, were made and evaluated for foam/lather sustainment upon dispensing and mixing the two compositions. The figure illustrates the foam volume dynamics beginning at time zero and extending out to 5 minutes. As one can see from the figure, the samples substantially maintained the level of foam from a 30 second time measurement point to a five minute time measurement point. [0033] The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Instead, unless otherwise specified, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as “40 mm” is intended to mean “about 40 mm.” [0034] All documents cited in the Detailed Description of the Invention are, in relevant part, incorporated herein by reference; the citation of any document is not to be construed as an admission that it is prior art with respect to the present invention. To the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern. [0035] While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Non-pressurized shaving compositions are described that provide a warm/hot sensation during use as the result of an exothermic redox reaction. The compositions are post-foaming via nascent gas release in situ due to the generation of carbon dioxide. The carbon dioxide induced foam is maintained for several minutes after the compositions are dispensed, whereby the compositions are capable of providing both a warm sensation and sustained lather, a balance which heretofore has been a significant challenge.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This non provisional application claims the benefit of French Application No. 03 05557 filed on May 7, 2003, and U.S. Provisional Application No. 60/472,463 filed on May 22, 2003, the entire disclosure of which is incorporated by reference herein. FIELD OF INVENTION [0002] The present invention relates to devices and methods for treating the hair, and more particularly hair roots. BACKGROUND [0003] Devices for applying substance to the hair are known from French patent documents FR-A-2,828,999 and FR-A-2,805,442. SUMMARY OF THE INVENTION [0004] Exemplary embodiments of the present invention provide devices and methods that give volume to the hair, for example, by applying substance to hair roots that hardens as the substance dries so as to cause the hair roots to be more upstanding on the scalp. [0005] In various exemplary embodiments, the invention provides a novel device that enables such a substance to be applied. [0006] In various exemplary embodiments, the invention provides a device comprising: a receptacle containing a substance for application to at least one of the hair and the scalp; a lifter member for lifting the hair, the lifter member being secured to the receptacle and movable relative thereto; and at least one dispenser endpiece for dispensing the substance on at least one of the hair and the scalp, after the hair has been lifted by the lifter member. [0007] Various exemplary embodiments of the invention allow a user to easily apply a substance to the hair for the purpose of stiffening the root ends thereof while the hairs are upstanding on the scalp, thereby obtaining a desired volume effect. [0008] Since the lifter member that lifts the hair is secured to the receptacle, in such embodiments the device is advantageously made in such a manner as to enable the user to actuate the lifter member using a same hand as is being used to hold the receptacle. Thus, the other hand of the user remains available, for example, for helping to obtain a desired hairstyle. [0009] In exemplary embodiments, the receptacle preferably includes a substance dispenser valve which is actuated by moving the lifter member. This makes the device simpler to use. [0010] Further, in exemplary embodiments, the device preferably includes a dispenser endpiece distinct from the lifter member. This makes it possible, for example, to spray substance in a direction substantially perpendicular to a portion of the hair that extends between the scalp and the lifter member. [0011] In exemplary embodiments, the lifter member advantageously comprises a comb, for example, having at least one row of teeth, or indeed a single row of teeth. The teeth may have bases that are in alignment. For example, the comb may comprise two to forty teeth. Further, the comb may comprise five to twenty teeth. Free ends of the teeth may point in a direction that is substantially away from the receptacle, particularly while the lifter member is being actuated. [0012] In exemplary embodiments, the hair lifter member may advantageously include an actuator portion defining a location on which the user can press in order to cause the lifter member to move relative to the receptacle. [0013] In exemplary embodiments, the lifter member may be connected via at least one tab to a base portion fastened on the receptacle. The tab may include at least one film-hinge. For example, the lifter member may include two such tabs, each provided with a film-hinge and spaced apart from each other sufficiently to enable the dispenser endpiece to engage therebetween while dispensing the substance, after the lifter member has been moved to lift the hair. [0014] In exemplary embodiments, the device may also include a portion for bearing against the scalp, which portion may be stationary relative to the receptacle. The bearing portion may rest on the scalp while the lifter member is being moved to lift the hair. The bearing portion may comprise, for example, two rods which may be parallel and situated at equal distances from the dispenser endpiece. For example, the rods may be of a length that is selected so that free ends thereof are at substantially a same level as the bases of the teeth of the comb, prior to the lifter member being actuated, and when the device is observed in a direction perpendicular to a longitudinal axis of the receptacle. [0015] In exemplary embodiments, the dispenser endpiece may include an abutment against which the lifter member can bear at an end of displacement thereof. The abutment can come into contact, for example, with the actuator portion of the lifter member. [0016] In exemplary embodiments, the dispenser endpiece may be connected to the base portion via at least one film-hinge, and the abutment may be situated on a side of the dispenser valve that is opposite from the film-hinge. [0017] The dispenser endpiece may be provided with a nozzle arranged to generate a spray. [0018] The substance contained in the receptacle may contain polymers and may have a drying time that is relatively short, for example, less than 30 seconds. [0019] Exemplary embodiments of the present invention provide a device for treating the hair, the device comprising: a receptacle containing a substance for application to at least one of the hair and the scalp; a lifter member for lifting the hair, the lifter member comprising a comb secured to the receptacle and movable relative thereto; and at least one dispenser endpiece for dispensing the substance on at least one of the hair and the scalp, after the hair has been lifted by the lifter member. [0020] In exemplary embodiments, the comb may comprise at least one row of teeth, for example, a row of two to forty teeth. Free ends of the teeth may point in a direction going substantially away from the receptacle, for example, while the lifter member is being actuated. [0021] Exemplary embodiments of the present invention provide a hair treatment device comprising: a receptacle containing a substance for application to at least one of the hair and the scalp, and including a substance dispenser valve; a lifter member for lifting the hair, the lifter member being secured to the receptacle and movable relative thereto, movement of the lifter member enabling the substance dispenser valve to be actuated; and at least one dispenser endpiece for dispensing the substance onto at least one of the hair and the scalp, after the hair has been lifted by the lifter member. [0022] Exemplary embodiments of the present invention provide a hair treatment device comprising: a receptacle containing a substance for application to at least one of the hair and the scalp; a hair-lifter member secured to the receptacle and movable relative thereto; and at least one dispenser endpiece for dispensing the substance on at least one of the hair and the scalp, after the hair has been lifted by the hair-lifter member; the hair-lifter member being connected via at least one film-hinge to a base portion that is fastened to the receptacle. [0023] In exemplary embodiments, the hair-lifter member may be connected to the base portion via at least one tab, for example, two tabs, each provided with a respective film-hinge, the tabs being spaced apart from each other sufficiently to allow the dispenser endpiece to engage therebetween while dispensing the substance, after the hair-lifter member has been displaced to lift the hair. [0024] Exemplary embodiments of the present invention provide a method of applying a substance to the hair, the method comprising: providing a device as defined above; lifting the hair with the hair-lifter member; and dispensing a substance onto the roots of the hair when lifted. [0025] After the substance has been dispensed, the hair can be held in a desired lifted position for a length of time that is sufficient to allow the substance to dry. BRIEF DESCRIPTION OF THE DRAWINGS [0026] The invention can be better understood on reading the following detailed description of non-limiting embodiments thereof, and on examining the accompanying drawings, in which: [0027] [0027]FIG. 1 is a diagrammatic elevation view showing a device according to an exemplary embodiment of the invention; [0028] [0028]FIG. 2 is a side view of the exemplary device as seen looking along arrow II of FIG. 1; [0029] [0029]FIG. 3 is a diagrammatic and fragmentary axial section view of the exemplary device taken along line III-III of FIG. 1; and [0030] FIGS. 4 to 6 illustrate the exemplary device of FIGS. 1 to 3 in use for giving volume to the hair. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS [0031] [0031]FIG. 1 show a device 1 comprising a receptacle 2 containing a substance pressurized by a propellant gas, for example, a substance rich in polymers and suitable for drying quickly, together with a dispenser head 3 fastened on the receptacle 2 via a base portion 4 . As shown in FIG. 3, the base portion 4 may comprise an assembly skirt 5 snap-fastened in an annular groove 6 near a top of the receptacle 2 . In the exemplary embodiment shown, the receptacle 2 includes a cup 7 that supports a dispenser valve 8 , the cup 7 being crimped to the body of the receptacle 2 . [0032] In a conventional manner, the dispenser valve 10 may comprise a hollow control rod 11 , a body 12 held by the cup 7 and into which the rod 11 can be depressed, and a spring 13 for returning the rod 11 into a position in which the rod 11 bears via a sealing lip 14 against an annular gasket 15 . In this position, the lip 14 closes off communication between an inside of the body 12 and a lateral orifice 16 of the rod 11 , through which orifice 16 the substance can flow from the receptacle 2 when the rod 11 is depressed. [0033] In embodiments of the invention, the dispenser head 3 also comprises a hair-lifter member 20 and a dispenser endpiece 30 . [0034] The hair-lifter member 20 may comprise a comb 21 and an actuator portion 22 against which a user can press to move the comb 21 , thereby lifting the comb 21 . [0035] In the exemplary embodiment shown, the comb 21 and the actuator portion 22 are made integrally by molding a plastics material, together with two tabs 23 that connect to the base portion 4 , each having a thin portion 24 defining a film-hinge, thereby enabling the comb 21 and the actuator portion 22 to pivot about an axis perpendicular to the plane of FIG. 3 and to a longitudinal axis X of the receptacle 2 when the user presses on the actuator portion 22 . The base portion 4 may be made integrally, i.e., monolithically, with the tabs 23 . It should be understood that the thin portion 24 may be replaced by any other suitable hinge means, either known or hereafter developed. [0036] In the exemplary embodiment shown, the comb 21 comprises a row of teeth 25 having bases 26 that are in alignment, and free ends 27 of the teeth 25 that are directed generally away from the receptacle 2 . [0037] The dispenser endpiece 30 and the comb 21 are offset along the axis X. Further, the endpiece 30 comprises a body 31 of generally frustoconical shape, in the exemplary embodiment shown, provided with an internal channel 32 whose bottom end opens into a housing 33 that receives an end of the control rod 11 . The house 33 is extended downward by a cone 35 that facilitates insertion of the rod 11 . [0038] The body 31 of the dispenser endpiece 30 receives a nozzle 36 at a top end thereof and is connected to the base portion 4 by a tab 37 made integrally, i.e., monolithically, with the body 31 , the tab 37 including a thin zone 38 defining a film-hinge. Thus, the body 31 and the dispenser endpiece 30 can pivot about an axis that is substantially parallel to the axis about which the lifter member 20 can tilt. The tabs 37 can be made integrally, i.e., monolithically, with the base portion 4 . As sown in FIG. 3, the thin zones 24 and 38 are situated on a same side of the device 1 relative to the axis of the control rod 11 , which coincides with the axis X. [0039] On a side remote from the tab 37 , the dispenser endpiece 30 is made to have an abutment 39 against which the actuator portion 22 can come to bear when the user presses thereon, for example, with an index finger I, as shown in FIGS. 4 to 6 . [0040] In the exemplary embodiment shown, the device 1 further comprises two rods 40 that extend parallel to the longitudinal axis X of the receptacle 2 and are connected to the base portion 4 in a vicinity of the assembly skirt 5 . [0041] Free ends 41 of the rods 40 are rounded in shape and are situated substantially at a same level as the bases 26 of the teeth prior to the hair-lifter member 20 being actuated, as shown in FIG. 3. [0042] The device 1 may be used as follows. [0043] A user takes hold of the receptacle 2 in one hand, placing the index finger I on the actuator portion 22 , and slides the comb 21 tangentially to the scalp S so as to select a portion of the hair that is to be made to stand up, as shown in FIG. 4. The user can take advantage of the rods 40 which bear against the scalp S. [0044] Once the device 1 is in place, the user can press on the actuator portion 22 until the actuator portion 22 comes into abutment with the abutment 39 on the dispenser endpiece 30 . [0045] The pressure exerted by the index finger I lifts the comb 21 so that the comb 21 takes up an angle relative to an initial orientation of the comb 21 . The hair-lifter member 20 is made somewhat easier to move by the presence of the rods 40 . [0046] The hair taken between the teeth 25 of the comb 21 follows the movement so the roots R of the hair extend in a direction substantially perpendicular to the scalp S, thereby exposing the hairs for subsequent operations, as shown in FIG. 5. [0047] By pressing a little harder on the actuator portion 22 , the abutment 39 of the dispenser endpiece 30 is caused to move, thereby entraining the control rod 11 and opening the dispenser valve 10 , thus causing the spray to be released. The spray is deposited directly on the roots of the hair, between the scalp S and the portion of the hair that is engaged in the comb 21 , as shown in FIG. 6. [0048] Once the desired quantity of substance has been deposited, the user can relax the pressure applied to the actuator portion 22 a little so as to cause dispensing of the substance to stop. [0049] The user can hold the hair-lifter member 20 in this intermediate position for a length of time needed to allow the substance to dry, thus enabling the roots R to be fixed in a desired position so as to give the hair a desired volume. When the user releases the actuator portion 20 , the actuator portion can return to the initial position shown in FIG. 2, for example, because the thin zones 24 possess a certain amount of shape memory. [0050] Naturally, the invention is not limited to the exemplary embodiment described above. [0051] Exemplary embodiments of the invention contemplate that the shape of the hair-lifter member can be modified. For example, it is possible to use hair-holding elements of some other form. It is also possible to modify the shape of the dispenser endpiece and the shape of the actuator portion, amongst other possible modifications. Where appropriate, the hinge of the hair-lifter member and/or the means for possible return thereof to the initial position can be provided other than by a film-hinge. [0052] Throughout the description, including in the claims, the term “comprising a” should be understood as being synonymous with “comprising at least one,” unless specified to the contrary. [0053] Although the present invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention.

Embodiments of a device for treating the hair includes: a receptacle containing a substance to be applied to at least one of the hair and the scalp; a lifter member for lifting the hair and comprising a comb secured to the receptacle and movable relative thereto; and at least one dispenser endpiece for dispensing the substance on at least one of the hair and the scalp after the hair has been lifted by the lifter member.

FIELD OF THE INVENTION [0001] The invention concerns a large round baler with a chassis and a discharge gate that can be pivoted vertically from it. BACKGROUND OF THE INVENTION [0002] Known large round balers, that disclosed in EP-0-651 939 B1, for example, consist of a chassis carried on wheels at whose rear side a discharge gate is connected in joints so as to be pivoted vertically. A baling chamber is formed in the chassis and the discharge gate in which a cylindrical bale can be produced. In this baler, the baling chamber is divided along a near vertical plane, and a support arrangement for a completed bale is mounted to the discharge gate and located near this plane. As soon as the cylindrical bale has reached its maximum size, the gate is raised so that the support arrangement swings upwardly from beneath the bale which is then deposited on the ground. Thereby the gate is raised so far that the baler can be operated further, without the danger of a collision between the gate and the cylindrical bale. [0003] A further known large round baler structure, that is disclosed in DE 3710550 C1, for example, consists of a chassis carried on wheels and includes a discharge gate including upper and lower sections which cooperate with the chassis to define a baling chamber in which a cylindrical bale can be produced. In this baler the chamber is divided along a plane which is inclined slightly from vertical from bottom to top. The discharge gate is constructed of upper and lower sections, which are each separately pivotally connected to the chassis. The lower section is pivoted at a lower rear location of the chassis for movement between a raised, closed position and a lowered open position, while the upper section is pivoted to an upper rear location of the chassis for movement between a lowered closed position and a raised open position. [0004] Still another known large round baler structure, that is disclosed in DE 3501 062 A1, for example, consists of a chassis carried on wheels and includes a discharge gate that cooperates with the chassis to define a chamber in which bales are formed, the gate meeting with the along a plane which is inclined forwardly from bottom to top. A bale supporting arrangement is mounted to the chassis and the gate is equipped with special structure to aid in the discharge of a completed bale. [0005] The problem underlying the invention is seen in the fact that, in the case of balers constructed like the first and last of the above-described prior art balers, the time interval for an adequate raising of the discharge gate is too long, with the last-mentioned prior art structure having the additional disadvantage or requiring special structure for aiding in the discharge of a bale; and in the case of the second of the above-described prior art balers, the movement of the two gate sections between the open and closed positions has to be properly sequenced to avoid interference, and the ground contour or other obstacles may prevent the lower gate section from achieving a completely open position during discharge of a bale. SUMMARY OF THE INVENTION [0006] According to the present invention, there is provided an improved discharge gate arrangement for a large round baler. [0007] An object of the invention is to provide a large round baler having a discharge gate which can be raised more rapidly and/or with less force. This object is accomplished at least in part due to the discharge gate arrangement being constructed of separate sections. If the further part or parts are supported in bearings on the chassis so that they can be repositioned, the load on the bearing location of the first part is reduced. Furthermore the further part or parts can be supported in bearings in such a way that their pivoting movements can be shaped optimally. [0008] A more specific object of the invention is to provide a discharge gate, as defined in the previous object, including separate gate sections which are more advantageously positioned and driven than those of the prior art so that by pivoting one of the gate parts or sections through a first angular displacement the other gate part or section travels through an angular displacement substantially greater than said first angular displacement. A simple and reliable way of a common repositioning, that depends on one another and differs in the degree of movement of both parts, can be attained by having the first part come into contact with the further part and that the spacing between the point of contact and each of the pivot axes is different. In this way a small lifting of the first part can bring about a relatively large degree of lifting of the further part, so that the entire baling chamber is freed very rapidly. In accordance with further embodiments of the invention, the interdependency may be achieved mechanically through usage of guide arms or links, for example, or hydraulically, through usage of master and slave motors. [0009] Still another specific object of the invention is to provide a discharge gate arrangement that may be constructed of two or more parts or sections that are slid over one another as in a fan, or are lined up one behind the other. [0010] The arrangement of bearings on the chassis spaced at least vertically possibly also spaced horizontally to accept the first and the further part on the chassis represents an effective translation of the movement of the first part during the transition to the movement of the further part. [0011] These and other objects will become apparent from a reading of the ensuing description together with the appended drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0012] [0012]FIG. 1 is a schematic left side view of a large round baler constructed in accordance with a first embodiment of the present invention, with a chassis and a discharge gate including a first and a further part separate pivotally attached to the chassis and being shown in solid lines in a closed baling position and in broken lines in an open ejection position. [0013] [0013]FIG. 2 is a view like FIG. 1, but showing a second embodiment of the invention, with the first and further parts of the discharge gate being shown in the open ejection position. [0014] [0014]FIG. 3 is a view like FIG. 1, but showing a third embodiment of the invention, with the first and further parts of the discharge gate being shown in the open ejection position. [0015] [0015]FIG. 4 is a view like FIG. 1, but showing a third embodiment of the invention, with the first and further parts of the discharge gate being shown in the open ejection position. DESCRIPTION OF THE PREFERRED EMBODIMENT [0016] Preliminarily, it is to be noted that throughout the specification, various components are indicated as occurring in multiples while only one of the components is shown, with it to be understood that the other component is identical to, or a right-hand version, of the one shown. [0017] The large round baler 10 includes a chassis 12 , that is supported by wheels 14 on the ground and that can be connected by means of a tow bar or tongue 16 to a towing vehicle, not shown, for example, an agricultural tractor. [0018] A crop pick up or recovery arrangement 18 is located in known manner on the front, lower side of the chassis 12 , with a front part of the chassis 12 defining a front part of a baling chamber 20 . At a rear, upper corner region of at each side of the chassis 12 , a first bearing 22 is located which provides support for a first part 24 of a discharge gate 30 , and underneath and to the rear of that is located a second bearing 26 for a second or further part 28 of the gate 30 . For the repositioning of the discharge gate 30 , described in greater detail below, an extensible and retractable servo motor 32 is provided on each side of the baler 10 . [0019] The baler 10 according to this invention is conventional, with regard to its baling function, with the baling chamber 20 being of invariable size, and for this purpose it contains a multitude of baling components extending parallel to each other, such as baling rolls, whose axes of rotation are located on a circular arc and of which at least several are driven. Alternatively the baler 10 can also be configured as one with a baling chamber of variable size. Therefore the configuration of the baler 10 will be described here only insofar as it concerns the invention. [0020] The chassis 12 ends at its rear side generally with a rear edge 34 located along a plane of separation inclined slightly forward from rear to front, at which the first part 24 of the gate 30 is in contact and is retained during the baling process. In an embodiment, not shown, the edge 34 could also extend vertically or be inclined to the rear. This edge 34 cuts the baling chamber 20 essentially at its center, but, as will become apparent from the description below, does not does not extend completely to the outer periphery of the baling chamber. [0021] The first bearing 22 is located in the immediate vicinity of the edge 34 at its upper end, as is known from conventional balers. The first bearing 22 may consist of bearing halves, bushings or the like, that engage a shaft, a tube or the like, free to pivot, that is or are connected with the first part 24 of the discharge gate 30 . On the side of the baler 10 not visible to the observer, a further first bearing 22 is provided analogously. [0022] The first gate part 24 corresponds generally to the upper region of a conventional discharge gate and is provided in its interior with components (not shown), for example, baling rolls and/or belts and/or chains that partially surround the baling chamber 20 . These components of the first gate part 24 extend around the circumference of approximately half of that portion of the baling chamber 20 located in the discharge gate 30 , and is provided with opposite side walls 36 . On the side wall 36 facing the observer, a driver 38 is located, that is configured in the form of a journal, a pin or the like and that extends to the side. In this special embodiment, the driver 38 engages a roll 40 , free to rotate, however, this is not required. The roll 40 can engage the driver 38 , for example, by means of a roller bearing or sliding bearing, not shown, and its use, as made clear in the description below, has the advantage that a relative movement in the radial direction created by the relative movement of the two parts 24 and 28 against each other can be transmitted with as little friction as possible. The driver 38 is located so that it is spaced at a distance from the first bearing 22 on the side wall 36 and at a height below the second bearing 26 . [0023] The visible second bearing 26 is located considerably behind the edge 34 and is attached to the chassis 12 by means of a console or bracket 42 , that, in this case, is triangular in shape and extends alongside a respective one of the sides 36 of the first part 24 . A further second bearing 26 and another console 42 are provided on the other side of the baler 10 . The second bearing 26 can be configured the same as the first bearing 22 . [0024] The further or second gate part 28 supplements the first part 24 to form the complete discharge gate 30 , that surrounds the baling chamber 20 in the region that is not surrounded by the chassis 12 . The further gate part 28 is smaller than the first gate part 24 , but supports approximately half the bale-forming components of the discharge gate 30 . The further gate part 28 is located underneath the first gate part 24 and extends under the chassis 12 and, in this embodiment, up to the recovery arrangement 18 . The further gate part 28 contains a circumferential region 44 that is formed essentially by a plurality of baling components 46 extending between opposite side plates. Arms 48 are provided at the opposite sides and have rear bottom ends that are rigidly connected with the circumferential region 44 , and have forward or upper ends mounted to the second bearing 26 for free vertical pivoting. The position of the second bearing 26 is selected in such a way that the further gate part 28 can be pivoted vertically past the rear side of the first gate part 24 . The arms 48 at the sides of the further gate contain driver eyes 50 , in each of which a respective one of the rolls 40 is received with play. If a straight line is drawn through both bearings 22 , 26 , then the driver 38 is located approximately equally far from the straight line in both end positions of the first part 24 , so that the play of the roll 40 in the driver eye 38 can be held to a minimum. Although the rolls 40 can be omitted, nevertheless some play exists. [0025] As can be seen from the drawing, the driver 38 is located to the rear of the second bearing 26 in the region of the arms 48 . Accordingly the distance between the driver 38 and the second bearing 26 is considerably less than the distance between the driver 38 and the first bearing 22 . A movement of the first part 24 about the first bearing 22 brings about a translated movement of the further part 28 about the second bearing 26 by reason of the contact of the driver 38 , or of the roll 40 carried by it, with the driver eye 50 . Accordingly, a very small angular displacement of the first part 24 when being raised brings about a relatively large angular displacement of the further part 28 . For example, as illustrated in FIG. 1, rotation of the first part 24 between its lowered closed position and raised open position results in an angular displacement of approximately 35° about the axis defined by the first bearings 22 . This movement is translated to the second part 28 and causes it to be displaced through an angle of approximately 70°, it being noted that the drawing shows the first part 24 and the further part 28 of the gate 30 respectively in solid lines in the closed position and in dashed lines in the ejection or discharge position. [0026] The servo motor 32 for the opening of the baling chamber 20 engages on the one hand a bearing, not shown, on the chassis 12 on the other hand the driver 38 , this is advantageous since it reduces cost and provides a direct transmission of the force at the point connecting both parts, but is not mandatory. [0027] Referring now to FIG. 2 of the drawing, there is shown a second embodiment of the invention, wherein the hydraulic servo motor 32 is coupled between the chassis 12 and the arm 48 of the second part 28 . The post 38 with the roller 40 are mounted to the wall 36 of the first gate part 24 at a location where the roller 40 is contacted by an edge of the arm 48 so as to translate upward motion of the arm 48 to the first part 24 . [0028] Referring now to FIG. 3, there is shown a third embodiment of the invention wherein the servo motor 32 is coupled between the chassis 12 and the arm 48 of the second part 28 , like in the second embodiment, but instead of using a driver, motion of the second part 28 is translated to the first part 24 by a link 52 . [0029] Referring now to FIG. 4, there is shown a fourth embodiment wherein a second hydraulic servo motor 54 , which may be plumbed to the motor 32 as a slave motor, is coupled between the chassis 12 and the arm 48 of the second part 28 . In this embodiment, actuation of the motor 32 results in actuation of the motor 54 . [0030] Referring now to FIG. 5, there is shown a fifth embodiment wherein the second part 28 is pivotally mounted, as at bearing 26 , to the first part 24 . In this embodiment, the servo motor 32 is connected between the chassis 12 and the second part 28 , with the driver 38 and roll 40 being fixed to the wall 36 of the first part 24 for being contacted by the upper edge of the arm 48 , so as to translate motion of the second part 28 to the first part when the second part is raised by the motor 32 . [0031] Having described the preferred embodiment, it will become apparent that various modifications can be made without departing from the scope of the invention as defined in the accompanying claims.

A large round baler includes a chassis which forms a forward part of a baling chamber, with a rearward part of the chamber being formed by a bale discharge gate. The discharge gate is constructed of first and second, separate parts that are, either each separately pivotally connected to chassis or are mounted such that the second part is pivotally attached to the first part. The parts are arranged such that arms of the second part overlap the opposite sides of the first part. Different embodiments disclose various driving structures for causing one part to be moved by moving the other part, with the arrangement of the two parts resulting in the gate being quickly moved to its open position for discharging a bale.

CROSS-REFERENCE TO RELATED APPLICATION The present application is based on and claims the benefit of priority of Japanese Priority Application No. 2013-168807 filed on Aug. 15, 2013, the entire contents of which are hereby incorporated by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a technique of controlling a network game. 2. Description of the Related Art Conventionally, in a game in which players cooperate with each other to battle against an enemy, in order to promote cooperative playing by the players of the players a so-called “combo” function exists, for example. A “combo” means that an attacking effect is increased (an ability value is increased, a damage to the opponent is increased, or the like) when ally players continuously attack the enemy within a predetermined period. For example, at the “combo” status, the ability value increases more than usual in accordance with the number of times, or the like, of the successive attacks by the ally players. Thus, the ally players cooperate with each other to attack in order not miss the chance. With such a function of the cooperative playing by the players, players are motivated to cooperate with other players to play the game on-line in real time. For example, Japanese Laid-open Patent Publication No. 2006-136350 discloses a technique in which information is exchanged by chats or the like between game terminal devices of members in the same team. As described above, in the conventional game, players may be motivated to cooperate with other players by the function of the cooperative playing by the players such as the “combo” or the like. However, it was not enough for increasing bonding between the players because once the players are on-line, players can obtain results in the game just by simply processing the game in accordance with a predetermined rule based on information of other players displayed in screens. Japanese Laid-open Patent Publication No. 2006-136350 does not disclose a mechanism by which players are motivated to take initiative to have communications with each other. SUMMARY OF THE INVENTION The present invention is made in light of the above problems, and provides a technique to activate communications between players. According to an embodiment, there is provided a game management server apparatus that provides, to a plurality of terminal devices connected via a network, a game service in which a plurality of players operating the terminal devices cooperate with each other to battle against an enemy, including: a storing unit that stores a battle history of a player; a generating unit that generates strategy guide information for conquering an opposing enemy; an attacking screen information generating unit that generates attacking screen information including the battle history and the strategy guide information; a communication screen information generating unit that generates communication screen information for a plurality of players to have communication with each other; and a screen information sending unit that sends the attacking screen information and the communication screen information to the terminal devices, wherein the attacking screen information generating unit generates attacking screen information in which display of the battle history and the strategy guide information are terminated when a predetermined condition is satisfied. BRIEF DESCRIPTION OF THE DRAWINGS Other objects, features and advantages of the present invention will become more apparent from the following detailed description when read in conjunction with the accompanying drawings. FIG. 1 is a view illustrating an example of a system structure of an embodiment; FIG. 2 is a view illustrating an example of a hardware structure of a terminal device; FIG. 3 is a view illustrating an example of a hardware structure of a game management server; FIG. 4 is a view illustrating an example of functional structures of the terminal device and the game management server; FIG. 5 is a view illustrating an example of a data structure of scenario information; FIG. 6 is a view illustrating an example of a data structure of party information; FIG. 7 is a view illustrating an example of a data structure of player information; FIG. 8 is a sequence diagram illustrating an example of a process of the embodiment; FIG. 9 is a view illustrating an example of a screen displayed on the terminal device; and FIG. 10 is a view illustrating an example of communications performed between players. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The invention will be described herein with reference to illustrative embodiments. Those skilled in the art will recognize that many alternative embodiments can be accomplished using the teachings of the present invention and that the invention is not limited to the embodiments illustrated for explanatory purposes. It is to be noted that, in the explanation of the drawings, the same components are given the same reference numerals, and explanations are not repeated. (Structure) FIG. 1 is a view illustrating an example of a system structure of the embodiment. In FIG. 1 , the system includes terminal devices (player terminals) 1 A, 1 B, 1 C, . . . possessed by players (users) such as a smartphone, a mobile phone or the like, access points 2 such as a mobile station, a Wi-Fi station or the like, a network 3 such as INTERNET or the like and a game management server 4 that manages (controls) a game in which a plurality of players play a game via the network. FIG. 2 is a view illustrating an example of a hardware structure of the terminal device 1 ( 1 A, 1 B, 1 C, . . . ). In FIG. 2 , the terminal device 1 includes a power source system 101 , a main system 102 including a processor 103 , a memory controller 104 and a peripheral interface 105 , a storing unit 106 , an external port 107 , a high frequency circuit 108 , an antenna 109 , an audio circuit 110 , a speaker 111 , a microphone 112 , a proximity sensor 113 , a GPS (Global Positioning System) circuit 114 , an I/O (Input/Output) sub system 115 including a display controller 116 , an optical sensor controller 117 and an input controller 118 , a touch panel display system 119 , an optical sensor 120 and an input unit 121 . FIG. 3 is a view illustrating an example of a hardware structure of the game management server 4 . In FIG. 3 , the game management server 4 includes a CPU (Central Processing Unit) 4002 , a ROM (Read Only Memory) 4003 , a RAM (Random Access Memory) 4004 , an NVRAM (Non-Volatile Random Access Memory) 4005 and an I/F (Interface) 4006 connected to a system bus 4001 , an I/O (Input/Output Device) 4007 for a keyboard, a mouse, a monitor, a CD/DVD (Compact Disk/Digital Versatile Disk) drive or the like, an HDD (Hard Disk Drive) 4008 and an NIC (Network Interface Card) 4009 connected to the I/F 4006 , a monitor 4010 , a game progression control unit 411 , a strategy guide information generation unit 412 and the like. FIG. 4 is a view illustrating an example of functional structures of the terminal device 1 ( 1 A, 1 B, 1 C, . . . ) and the game management server 4 . In FIG. 4 , the terminal device 1 includes a player operation input unit 11 , a game logic processing unit 12 , a server accessing unit 13 and a screen display unit 14 . The player operation input unit 11 has a function to input (accept) an operation of a player that operates the terminal device 1 . The game logic processing unit 12 has a function to process a game by transitioning screens in accordance with an input operation of the player input by the player operation input unit 11 . The game logic processing unit 12 has a case in which a game logic is processed based on page data described in an HTML (Hyper Text Markup Language) or the like from the game management server 4 and scripts or the like included in the page data (which is called as a browser type) and a case in which the game logic is processed based on an application that is previously downloaded and installed in the terminal device 1 (which is called as an application type). The server accessing unit 13 has a function to send a request to the game management server 4 and receives a processed result or the like as a response from the game management server 4 when it is necessary to access the game management server 4 in a course of the processing by the game logic processing unit 12 . Here, the request includes a updating request and a data referring request. The updating request is to update player information or the like. The data referring request is to refer to the player information or the like. The response from the game management server 4 includes screen information for displaying screens at the terminal device 1 side. The screen display unit 14 has a function to display screens under control of the game logic processing unit 12 . Meanwhile, the game management server 4 includes a request processing unit 41 , a scenario information storing unit 42 , a party information storing unit 43 and a player information storing unit 44 . The request processing unit 41 includes a game progression control unit 411 , a strategy guide information generation unit 412 , a battle history obtaining unit 413 , an attacking screen information generation unit 414 , a communication control unit 415 , a communication screen information generation unit 416 and a screen information sending unit 417 . The request processing unit 41 has a function to receive a request from the terminal device 1 , perform a corresponding process and send a processed result of the request to the terminal device 1 . For the updating request, the request processing unit 41 performs a process including updating the player information or the like, and the processed result is the player information or the like changed by the process. For the data referring request, the request processing unit 41 refers to the corresponding player information or the like, and the processed result is a value of the obtained player information or the like. Further, for the browser type, the response includes screen information for directly displaying a screen that can be a next operation target by the player, in addition to the requested processed result. Even for the application type, information used for displaying screens at the terminal device 1 side is referred to as screen information. The scenario information storing unit 42 stores scenario information that defines progression of the game. Here, the scenario information may include only definition information without a limitation of format, or may be integrally structured with a program of the game progression control unit 411 . FIG. 5 is a view illustrating an example of a data structure of the scenario information stored in the scenario information storing unit 42 . The scenario information includes an event condition including elements such as a status (a degree of game progression of a player or a party, which is a group (a team) of the player), time zone, party attribution or the like, and an event content for the case when the event condition is satisfied including elements such as screen display condition/display content, parameter updating condition/updating content or the like. Referring back to FIG. 4 , the party information storing unit 43 stores party information. In this embodiment, a case is assumed in which parties battle (oppose) with each other. Here, there is a case that the opponent of the battle is a boss (boss character) controlled by the system. The party can go up to a higher stage (ranking) by performing and winning battles. FIG. 6 is a view illustrating an example of a data structure of the party information stored in the party information storing unit 43 . The party information includes party ID, party name, obtained points, combo number, last combo date/time, last combo player ID and log data. The party ID is data to identify a party. The party name is the name of the party. The obtained points are points obtained by the party. Whether the battle is won is determined by the obtained points when the limited time of the battle ends. Here, the combo number is the number of the last consecutive combo where players who belong to the party cooperate with each other to form a combo. The last combo date/time is date and time when the last combo is formed. The last combo player ID is data for identifying a player who made an attack when the last combo is formed. The log data is history information of plays (mainly battles) performed by the players who belong to the party. The log data includes player ID, date/time, attacking type, opposing party ID and damage. The log data may be separately stored in corresponded with the party ID or the player ID. Referring back to FIG. 4 , the player information storing unit 44 stores information of players who participate in the game. FIG. 7 is a view illustrating an example of a data structure of the player information stored in the player information storing unit 44 . The player information includes player ID, belonging party ID, display name, display icon and attacking points. The player ID is data to identify a player. The belonging party ID is data to identify the party to which the player belongs. The display name is display name of the player. The display icon is image data for symbolically displaying the player. The attacking points are necessary when the player makes an attack and are consumed by making the attack. When all of the attacking points are consumed, the player cannot attack anymore. By designing the game that the attacking points are necessary for attacking, the number of attacking times can be limited and it is expected that the players make much account of communications in order to carefully make attacking. However, for another game design, attacking may be made without a need of attacking points. A damage caused to the opposing party by the attacking is determined by attacking/defending parameters or the like of the attacking side/opposing side. Referring back to FIG. 4 , the game progression control unit 411 of the request processing unit 41 of the game management server 4 has a function to progress a game in response to the request from the terminal device 1 based on the scenario information (the scenario information storing unit 42 ), the party information (the party information storing unit 43 ) and the player information (the player information storing unit 44 ). Further, the game progression control unit 411 also has a function to determine whether a combo is formed. When another attack by another player in the same party is made within a predetermined period (10 minutes, for example) from an attack by a player in a party is made, it is determined that a combo is formed. When the same player makes attacks or the predetermined period has passed, the combo is not formed. Whether the combo is formed is determined from the player ID of the player who made the attack, the party ID, the current date/time, and the party ID, the combo number, the last combo date/time and the last combo player ID of the party information ( FIG. 6 ). Further, the game progression control unit 411 has a function to terminate (blind), when a command of activating a blind function (blin function) is performed by a player of a party, display of strategy guide information, which will be explained later, and the battle history to all of the players of the opposing party for a predetermined period (5 minutes, 10 minutes, until game end or the like, for example) within which the blind function is effective. Display of a point gauge to the opposing party may be terminated. For terminating display, those information are not included in screen information, or an image processing is performed so that those information cannot be read. Here, it is assumed that display of the additionally provided (fed) strategy guide information and the battle history in accordance with the game progression are terminated and display of an image or the like showing a formation of a combo or the like, which is displayed in an original game screen is not terminated. However, in order to perfectly effect the blind function, information regarding the strategy guide information and the battle history may be removed from all of the game screens. Under control of the game progression control unit 411 , the strategy guide information generation unit 412 has a function to generate strategy guide information for advantageously proceeding in the game, for presenting the players, based on the scenario information, the party information and the player information. The strategy guide information is, in particular, content notifying attacking timing for each of the players to form a combo. The strategy guide information is, for example, content such as “5 SUCCESSIVE ATTACKING COMBOS! ATTACKING POWER 30% UP! CHANCE!”. The strategy guide information is generated by predicting a combo capable of being formed based on the player ID of a player to be provided, the party ID, the current date/time, and the party ID, the combo number, the last combo date/time and the last combo player ID of the party information ( FIG. 6 ) and combining with a previously prepared message. Under control of the game progression control unit 411 , the battle history obtaining unit 413 has a function to obtain a battle history (play history) of each of the players of the both of the parties having a battle for presenting the players based on the party information and the player information. The battle history includes display icons (attacking side and attacked side), display name (attacking side), attacking date/time and attacking content. More specifically, the battle history obtaining unit 413 generates the battle history from the log data of the party information ( FIG. 6 ) and the player information ( FIG. 7 ). Under control of the game progression control unit 411 , the attacking screen information generation unit 414 has a function to generate attacking screen information based on original game screen information (including a case with voice information) for a game progression, the strategy guide information generated by the strategy guide information generation unit 412 and the battle history obtained by the battle history obtaining unit 413 . The communication control unit 415 has a function to control sending and receiving communication information in a free format such as a so-called chats or the like between players in the same party. Under control of the communication control unit 415 , the communication screen information generation unit 416 has a function to generate communication screen information for sending and receiving chats. In order to simplify an input operation of a message to send, sample sentences or the like may be displayed in a selectable manner to have the players select a desired one or change a part. The screen information sending unit 417 has a function to send the attacking screen information generated by the attacking screen information generation unit 414 and the communication screen information generated by the communication screen information generation unit 416 to the terminal device 1 . (Operation) FIG. 8 is a sequence diagram illustrating an example of a process of the embodiment. In FIG. 8 , it is assumed that a player of the terminal device 1 A and a player of the terminal device 1 B belong to a party X while a player of the terminal device 10 belongs to a party Y. At a normal state (at a state that the blind function is not activated), when a updating request of a screen is sent from the terminal device 1 A, 1 B or 1 C (including a case operated by a player and a periodically performed case) to the game management server 4 (step S 101 , S 105 or S 109 ), the request processing unit 41 of the game management server 4 generates screen information normally including strategy guide information and a battle history (step S 102 , S 106 or S 110 ), and returns back to the requested terminal device 1 A, 1 B or 1 C (step S 103 , S 107 or S 111 ) to be displayed (step S 104 , S 108 or S 112 ). Here, although it is assumed that a so-called pull-type is performed in which the terminal device 1 A, 1 B or 1 C obtains up-to-date screen information, a so-called push type may be performed in which the game management server 4 sends up-to-date screen information to the terminal device 1 A, 1 B or 1 C. FIG. 9 is a view illustrating an example of a screen displayed on the terminal device 1 . Remaining time to the end is displayed in a region r 1 , a battle situation image is displayed in a region r 2 , party names are displayed in a region r 3 , point gauges of the parties are displayed in a region r 4 , and strategy guide information is displayed in a region r 5 . By displaying the remaining time, it is expected that the players are motivated to make the battle situation good earlier so that the communications in the party are activated. At this time, it is expected that the players can rapidly have communications with each other compared with a case using an external bulletin board or the like and use of a communication screen in the same screen is promoted. Further, a situation of the player is displayed in a region r 6 , and various kinds of command buttons are displayed in a region r 7 . The various kinds of command buttons include a button for activating combo boost that increases an attacking effect when being activated when a combo is formed and a button for activating a blind function by which display of the strategy guide information and the battle history to all of the players who belong to the opposing party is blinded, in addition to buttons for activating various kinds of attacking. These command buttons include one that can be activated at any time provided that an item or the like to activate the command is possessed, and further, one that can be activated only when timing, player attribution or a parameter condition is satisfied. Further, among a region r 8 and a region r 9 capable of switching by tabs, a battle history is displayed in the region r 8 and a communication screen for inputting and outputting chat or the like for having communications is displayed in the region r 9 . Referring back to FIG. 8 , thereafter, for example, when the player of the terminal device 1 C who belongs to the party Y operates to activate a blind function, and the request is sent to the game management server 4 (step S 113 ), the game management server 4 generates up-to-date screen information (step S 114 ) and returns it to the terminal device 1 C (step S 115 ) to be displayed (step S 116 ). The screen information at this time is the same as a normal one. On the other hand, when a request to update a screen is sent to the game management server 4 from the terminal device 1 A or 1 B of the player who belongs to the party X, to which the blind function is set (step S 117 or S 121 ), the request processing unit 41 of the game management server 4 generates screen information in which display of the strategy guide information and the battle history is terminated (step S 118 or S 122 ) and returns it to the requested terminal device 1 A or 1 B (step S 119 or S 123 ) to be displayed (step S 120 or S 124 ). Specifically, referring to the example of the screen illustrated in FIG. 9 , information of the strategy guide information in the region r 5 and the battle history in the region r 8 are not included in a display screen or a screen in which those information are processed to be unable to be read is displayed. Referring back to FIG. 8 , the player of the party X for which information is limited has to use a communication function because the player cannot obtain information to form a combo. Further, players previously often use the communication function anticipating and preventing the activation of the blind function. When the player of the terminal device 1 A who belongs to the party X inputs a message in the communication screen (step S 125 ), a request to send the message is sent to the game management server 4 (step S 126 ). Then, the game management server 4 generates communication screen information including the received message (step S 127 ) and sends it to the terminal device 1 B of the player who belongs to the same party X (step S 128 ) to be displayed (step S 129 ). Here, it is assumed that the message is delivered by a so-called push type so that the message can reach soon, however, the message may be obtained by the terminal device 1 B from the game management server 4 by a pull type. Thereafter, when the player of the terminal device 1 A who belongs to the party X operates to activate an attacking command and the request is sent to the game management server 4 (step S 130 ), the request processing unit 41 of the game management server 4 generates screen information in which the attack including formation of a combo is reflected (step S 131 ) and returns it to the terminal device 1 A (step S 132 ) to be displayed (step S 133 ). FIG. 10 is a view illustrating an example of communications performed between players. It is expected that various messages are sent and received before the battle, during the battle and after the battle and communications between players can be activated. As explained above, according to the embodiment, players are motivated to promptly have communications with each others and communications between players can be activated. In this embodiment, players are motivated to promptly have communications with each others and communications between players can be activated. Although a preferred embodiment of the invention has been specifically illustrated and described, it is to be understood that minor modifications may be made therein without departing from the spirit and scope of the invention as defined by the claims. The present invention is not limited to the specifically disclosed embodiments.

A game management server apparatus that provides, to terminal devices connected via a network, a game service in which players operating the terminal devices cooperate with each other to battle against an enemy, includes, a storing unit storing a battle history of a player; a generating unit generating strategy guide information for conquering an opposing enemy; an attacking screen information generating unit generating attacking screen information including the battle history and the strategy guide information; a communication screen information generating unit generating communication screen information for a plurality of players to have communication with each other; and a screen information sending unit sending the attacking screen information and the communication screen information to the terminal devices, wherein the attacking screen information generating unit generates attacking screen information in which display of the battle history and the strategy guide information are terminated when a predetermined condition is satisfied.

CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a National Stage Application of International Application No. PCT/FR01/00265, filed Jan. 26, 2001. Further, the present application claims priority under 35 U.S.C. § 119 of French Patent Application No. 00 01094 filed on Jan. 28, 2000. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a protective helmet, and more specifically a device for adjusting the helmet adapted to promote its positioning and adjusting as well as its fitting to the size of the user's head. 2. Discussion of Background Information Protective helmets have long been commonly used in various fields, whether for professional use as is the case for the military, plane or helicopter pilots, the police, or firefighters, or for civil or private use, as is the case for motorcycle riders, rally or race car drivers, or workers on a worksite. These prior art helmets are generally formed of an external rigid shell and an inner liner adapted to allow the positioning of the helmet and to promote the comfort of the user. They can also comprise an inner envelope of a synthetic material adapted to dampen the impacts. In these helmets, multiple types of adjustments are known to allow a precise positioning of the helmet and an adequate tightening of the tightening means in order to give optimum comfort to the one using the helmet. However, the prior art adjusting devices are not entirely satisfactory as they do not allow a sufficiently precise adjustment or require one to remove the helmet in order to carry out these adjustments. Additionally, they are generally complicated to implement and often require long and tedious handling. Thus, the prior art adjusting devices present drawbacks related to their implementation, use and reliability. The object of the present invention is to overcome the aforementioned drawbacks through arrangements that are simple, reliable, easy to implement and inexpensive. The invention proposes a protective helmet whose adjustment device is easy to use, quick and precise so as to promote the fitting of the helmet to the size of the user's head. SUMMARY OF THE INVENTION According to its main characteristic, the protective helmet of the invention is of the type formed of a shell adapted to protect the user's head and comprising an inner lining that has a headband of adjustable size due to an adjusting device, and it is characterized in that the adjusting device has two gripping members adapted to be manually brought together or spread apart by the user in order to vary the size of the headband. According to another characteristic of the protective helmet, the headband has a main band portion, two adjustment extensions that extend to the ends of the main band and bear the gripping arrangements, as well as a connecting element having locking arrangements adapted to cooperate with the adjustment extensions. According to a complementary characteristic of the protective helmet, the cooperation between the adjustment extensions and the locking arrangements of the connecting element occurs by a rack system. According to the preferred embodiment of the protective helmet of the invention, the headband is arranged on the inside of the helmet shell such that the connecting element is positioned at the rear of the helmet and that the gripping members are arranged substantially in the zone corresponding to the user's nape. According to another characteristic of the protective helmet, it is characterized in that the gripping members are arranged at the end of the adjustment extensions and have a transverse support surface extending downwardly (BA) below the planes containing the main band and the adjustment extensions. According to an additional characteristic of the protective helmet of the invention, it is characterized in that it comprises elastic biasing system arranged between the connecting element and the adjustment extensions or the band in order to bias the headband towards its loosened position against the locking arrangements. According to the preferred embodiment of the protective helmet, the elastic biasing system is formed by two return arms connecting the adjustment extensions to the connecting element and which bias the extensions due to their specific elasticity. According to another characteristic of the protective helmet of the invention, it is characterized in that the locking arrangement is constituted of two locking buckles that each comprise a locking lever bearing a locking projection adapted to cooperate with notches arranged on the external surface of the adjustment extensions and which each comprise an unlocking member. According to a complementary characteristic of the protective helmet, it is characterized in that the adjustment extensions comprise at their end, at the level of their gripping members, a guiding pin adapted to guide the sliding of the adjustment extensions with respect to the locking arrangements of the connecting element by sliding each one in a guiding slot arranged in the connecting element. Furthermore, it is noted that according to an alternative embodiment of the protective helmet, the gripping members are separated by a distance less than 15 centimeters. The invention also provides for a protective helmet comprising a shell adapted to protect a user's head, an inner lining, a headband comprising an adjusting device. The adjusting device includes two gripping members adapted to be manually moved towards or away from one another by the user in order to vary a size of the headband. The two gripping members may be adapted to be manually moved towards and away from one another by the user in order to vary a size of the headband. The headband may comprise a main band portion having two ends and an adjustment extension arranged at each end of the main band. Each adjustment extension may comprise one of the two gripping members. The headband may further comprise a connecting element. The connecting element may comprise a locking system adapted to cooperate with the adjustment extensions. The locking system may comprise two buckles each having a locking projection which engages notches of each adjustment extension. The locking system may comprise a rack system. The headband may be arranged on an inside of the shell. The headband may further comprise a connecting element positioned at a rear part of the helmet, and wherein the gripping members are arranged substantially in a zone corresponding to the user's nape. The headband may comprise a main band portion having two ends and an adjustment extension that is arranged at each end of the main band, whereby one gripping member is arranged on each adjustment extension. The headband may comprise a main band portion having two ends and an adjustment extension that is arranged at each end of the main band, whereby one gripping member is arranged on an end of each of the adjustment extensions. Each gripping member may comprise a support surface that extends downwardly and transversely relative to a plane running through the headband. The headband may comprise a main band portion having two ends and an adjustment extension that is arranged at each end of the main band, whereby one gripping member is arranged on an end of each of the adjustment extensions. The main headband portion may be arranged on a first plane and the adjustment extensions may be arranged on a second plane, the first and second planes being parallel to one another and being spaced apart by a distance. The protective helmet may further comprise an elastic biasing system acting to bias open the headband. The headband may comprise a main band portion having two ends, an adjustment extension that is arranged at each end of the main band, and a connecting element, whereby one gripping member is arranged on an end of each of the adjustment extensions. Each end of the main band portion may be connected to each adjustment extension and each adjustment extension may be connected to an end of the connecting element. The elastic biasing system may comprise arms which are connected to each adjustment extension in order to bias the headband towards a loosened position. The connecting element may comprise the elastic biasing system. The connecting element may comprise a system that locks each adjustment extension. The system that locks each adjustment extension may comprise two buckles each having a locking projection which engages notches in each adjustment extension. The system that locks each adjustment extension may comprise two buckles each having a locking lever and a projection which engages notches in each adjustment extension. The system that locks each adjustment extension may comprise two buckles each having an unlocking member, a locking lever, and a projection which engages notches in each adjustment extension. The elastic biasing system may comprise two return arms connecting the adjustment extensions to the connecting element, whereby the two return arms bias the adjustment extensions due to their specific elasticity. The headband may comprise a main band portion having two ends, an adjustment extension that is arranged at each end of the main band, and a connecting element connected to each adjustment extension at two locations, whereby one gripping member is arranged on an end of each of the adjustment extensions. The headband may comprise a main band portion having two ends, an adjustment extension that is arranged at each end of the main band, and a connecting element connected to each adjustment extension. Each adjustment may comprise a guiding device adapted to slidingly engage the connecting element. Each guiding device may comprise a pin which engages a guiding slot in the connecting element. The connecting element may comprise a system that locks each adjustment extension, the system that locks each adjustment extension comprising two buckles each having a passage which allows the adjustment extension to slide within, an unlocking member, a locking lever, and a projection which engages notches in each adjustment extension. The gripping members may be separated by a distance “d” of less than 15 centimeters when the headband is in a loosened position. The invention also provides for a protective helmet having a shell that protects a user's head, an inner lining system, an adjustable headband system, wherein the adjusting headband system comprises a main headband portion having a first end and a second end. A first adjustment extension device is coupled to the first end. A second adjustment extension device is coupled to the second end. Each of the first and second adjustment extension devices comprises a gripping member. A connecting element is coupled to the each of the first and second adjustment extension devices. The connecting element comprises an elastic biasing system which causes the gripping members to be biased away from one another. The invention also provides for a protective helmet having a shell that protects a user's head, an inner lining system, an adjustable headband system, wherein the adjusting headband system comprises a main headband portion having a first end and a second end. A first adjustment extension device is coupled to the first end. A second adjustment extension device is coupled to the second end. Each of the first and second adjustment extension devices comprises a gripping member. A connecting element has a portion that is non-movably coupled to each of the first and second adjustment extension devices. Each of the first and second adjustment extension devices is movably coupled to another portion of the connecting element. The connecting element comprises at least one of an elastic biasing system adapted to move the gripping members away from one another and a system that adjustably locks each adjustment extension at a number of positions. BRIEF DESCRIPTION OF THE DRAWINGS Other characteristics and advantages of the invention will become apparent from the following description, with reference to the attached drawings, which are given only as non-limiting examples. FIGS. 1-11 show a preferred embodiment of the protective helmet of the invention and its adjusting device, wherein: FIG. 1 is a perspective view of a protective helmet; FIG. 2 is a perspective view of the inside of the protective helmet; FIG. 3 is a perspective view of the headband and its adjusting device; FIG. 4 is an exploded view of the headband and its adjusting device; FIGS. 5 a - 5 c are rear views of the loosened position, the intermediary position and the tightened position of the headband; FIGS. 6 a - 6 c are bottom views of the headband in the positions of FIGS. 5 a - 5 c , respectively; FIG. 7 is a perspective view of the adjusting device; FIGS. 8 a , 8 b , 8 c , 8 d show the housing of the adjusting device, in perspective and top views, and in cross-section along AA and CC, respectively; FIG. 9 is a perspective view of the unlocking lever; FIGS. 10 a and 10 b are a front view and a lateral view of the adjustment extensions and their gripping member; FIG. 11 is a rear view of the middle connecting element on which the adjustment occurs; and FIGS. 12 a and 12 b are views similar to FIG. 5 a , showing two alternative embodiments according to which the headband has arrangements that enable the symmetrical displacement of the ends of the headband. DETAILED DESCRIPTION OF THE INVENTION The protective helmet having the general reference numeral 1 is adapted to protect the user's head and can be of any type, i.e., a firefighter's helmet or a military helmet, for example, but also a helmet for a mountain climber, a bicyclist, or any other type of helmet, without leaving the scope of protection for the invention. According to a preferred embodiment of the invention, it is a firefighter's helmet 1 as shown in FIGS. 1 and 2. It is constituted of an external shell 2 , advantageously made in one piece, that is adapted to surround the user's head, and of an inner lining 10 arranged on the inside of the shell to allow the positioning and the tightening thereof around the head. In particular, this lining 10 has a cap 4 formed of a flexible wall or a holding net 9 and a headband 5 whose size is adjustable due to an adjusting device 6 . According to the preferred embodiment of the helmet 1 of the invention, the headband 5 is adapted to surround the user's head to promote the hold of the helmet once it is positioned. The adjusting device 6 thus allows varying the useful length of the headband 5 , i.e., its diameter. To this end, the adjusting device 6 of the invention comprises two gripping members 7 a and 7 b that are adapted to be manually actuated by the user in order to be spaced apart or brought together, their actuating allowing one to vary the diameter of the headband 5 . These gripping members 7 a , 7 b extend downwardly BA below the headband 5 , and more specifically, below the plane containing the lower edge of the headband so that they can be more easily gripped and actuated by the user when the helmet 1 is positioned on the head. According to the preferred embodiment and as shown in FIGS. 3 and 4, the headband 5 is constituted by a main band portion 8 , two adjustment extensions 11 a and 11 b arranged at the free ends of the band 8 , a connecting element 12 and locking arrangements 13 born by the connecting element and adapted to cooperate with the adjustment extensions 11 a , 11 b . The cooperation between the locking arrangements 13 and the extensions 11 a , 11 b can be obtained by any system, such as a rack system as seen in the embodiment shown, for example, or by equivalent systems, such as wedging or the like. It is noted that the main band portion 8 forms at least half of the circumference of the headband 5 . According to the preferred embodiment of the helmet 1 of the invention, the gripping members 7 a , 7 b are borne by or arranged on the adjustment extensions 11 a , 11 b so as to extend below the headband 5 . The adjustment extensions 11 a , 11 b bear, on their outer surface, a set of notches 14 (see e.g., FIG. 10 a ) adapted to cooperate with the locking member 13 a of a buckle 13 that forms the locking arrangement. These extensions 11 a , 11 b have arranged, at one of their ends, the gripping member 7 a , 7 b and, at the other end, is arranged an attaching or assembly arrangement, such as a slot 15 , in order to be each assembled to one end of the main band 8 so as to form the extension thereof. It is noted, as shown in FIGS. 10 a and 10 b , that each adjustment extension 11 a , 11 b comprises a first longitudinal wall portion 16 a adapted to extend the main band, and a second longitudinal wall portion 16 b affixed to the first portion 16 a , and which bears the set of notches 14 . These two wall portions are arranged off-centered, one with respect to the other, in order to be placed in two distinct and parallel planes P 1 , P 2 . In this way, the second wall portion 16 b is located below the first 16 a . This second wall portion 16 b bears or includes, at its free end, the gripping member 7 a , 7 b that is formed at least partially of a transverse wall portion that is orthogonal to it. This member thus has a support surface 17 that is sufficient for allowing the user to bias it. This surface 17 extends transversely below the second wall portion 16 b of the adjustment extension 11 a , 11 b. It is noted that the assembly of the extensions 11 a , 11 b on the main band portion 8 , due to attaching arrangement 15 , can occur in a plurality of positions. As seen in FIG. 4, the slot 15 of the extensions is capable of cooperating with a plurality of positioning pins 18 of the band 8 . Thus, this plurality of possible assemblies multiplies the possibilities for adjusting the size of the headband 5 by being advantageously combined with the adjusting device 6 of the invention. It is understood that one would not leave the scope of the invention by making the band and its adjustment extensions in one single piece. According to the preferred embodiment of the helmet 1 of the invention, the locking buckles 13 adapted to cooperate with the extensions 11 a , 11 b are borne by or coupled to a rear connecting element 12 that partially forms the headband 5 . The headband 5 is arranged in the helmet so that the connecting element 12 is arranged centrally at the rear of the helmet 1 , substantially at the level of the user's nape. This connecting element advantageously has two guiding slots 19 adapted to cooperate with a guiding pin 20 for each of the adjustment extensions 11 a , 11 b shown in FIG. 10 b . It bears, at its lateral ends, two buckles 13 shown in FIGS. 8 a - 8 d , each forming a passage 21 for the adjustment extensions 11 a , 11 b , and each bearing a locking member 13 a , such as a central lever provided with a locking projection 22 adapted to cooperate with the notches 14 in order to allow the sliding of the extension 11 a , 11 b in the passage 21 , solely in a direction corresponding to the tightening of the headband, and to prevent any sliding in the opposite direction. As known, the locking buckles 13 have an unlocking member 23 adapted to bias the lever 13 a and its projection 22 so that the latter is no longer engaged with the notches 14 , and so that the adjustment extensions 11 a , 11 b can slide in the opposite direction and thus allow loosening the headband 5 . According to the preferred embodiment of the adjusting device 6 , the unlocking member 23 is a lever pivotally mounted on the body of the buckle 13 and adapted to cooperate with the locking lever 13 a by way of complementary ramps, as known. According to the invention, the headband 5 has elastic biasing system 25 adapted to bias it towards its loosened position A shown in FIGS. 5 a and 6 a , i.e., a position where the gripping members 7 a and 7 b abut against the buckles 13 of the connecting element. Thus, when the user actuates the loosening levers 23 of the buckles 13 , the elastic biasing system or members 25 bias the adjustment extensions 11 a and 11 b to slide in their passage 21 toward their loosened position A. According to the preferred embodiment, the elastic biasing system or members 25 are constituted of two return arms 25 formed by extensions of the rear connecting element 12 and which connect element 12 to the adjustment extensions 11 a , 11 b . Thus, when the user tightens the headband 5 , the return arms fold as seen in FIGS. 6 a - 6 c , thus biasing the adjustment extensions 11 a , 11 b against the locking arrangements 13 and 22 . As shown in FIG. 7, it is noted that the guiding devices 20 are located at the end of the adjustment extensions, at the level of the gripping members 7 a , 7 b in order to slide in the slots 19 of the connecting element 12 located between the two locking buckles 13 . Furthermore, when the headband 5 is in the loosened position A, the gripping members 7 a , 7 b are separated by a distance “d” which is less than 15 centimeters and advantageously equal to approximately 8 centimeters so as to facilitate their actuating by the user. It is also noted that the cooperation between the connecting element 12 and its buckles 13 and the adjustment extensions 11 a , 11 b occurs in a plane P 2 located below that in which the main portion of the band 8 and the return arms 25 are located (i.e., P 1 ), whereas the gripping members 7 a , 7 b extend downwardly below plane P 2 . According to the preferred embodiment, the constitutive members of the headband 5 , namely the main band portion 8 , the adjustment extensions 11 a , 11 b , the arrangements for locking and unlocking 13 , 22 and 23 , the connecting element 12 and its return arms 25 , are made of plastic and can be made by any method, such as by injection, for example. Nevertheless, the main portion of the band 8 and the connecting element 12 can comprise, on their inner surface, a padding adapted to provide comfort for the user. This padding can advantageously be glued or sewn on the band 8 , or it can be removably arranged, for example, by way of a quick fastener of the Velcro type (Registered Trademark). It is noted that the helmet 1 of the invention has a vertical plane P of general symmetry, and that it has arrangements allowing the adjustment extensions 11 a , 11 b to be displaced symmetrically with respect to this plane P. In the previously described embodiment, these arrangements include the elastic arms 25 such that, when the user unlocks the band due to his acting on the unlocking members 23 , the elastic arms 25 act simultaneously and jointly to symmetrically drive back each of the adjustment extensions 11 a , 11 b . FIGS. 12 a , 12 b show an alternative according to which the displacement of one of the adjustment extensions 11 a or 11 b causes the displacement of the other adjustment extension 11 a or 11 b . According to this alternative, the two adjustment extensions 11 a , 11 b are connected mechanically and kinematically by a central transmission sprocket 30 , rotatably mounted on the connecting element 12 in the general plane P. It is noted that sprocket 30 cooperates through diametrical meshing with two additional extensions 31 a , 31 b of the main band, extending the adjustment extensions 11 a , 11 b. According to the alternative embodiment shown in FIG. 12 a , the device also includes the elastic arrangements 25 of the first embodiment. According to the alternative of FIG. 12 b , the elastic arrangements are constituted of an elastic system, not shown, such as a spring that acts on the transmission sprocket 30 . Naturally, the invention is not limited to the embodiments described and shown by way of example, but it also encompasses all technical equivalents, as well as their combinations.

Protective helmet that includes a shell adapted to protect a user's head, an inner lining, and a headband having an adjusting device. The adjusting device includes two gripping members adapted to be manually moved towards or away from one another by the user in order to vary a size of the headband. This abstract is neither intended to define the invention disclosed in this specification nor intended to limit the scope of the invention in any way.

FIELD OF THE INVENTION The present invention relates to intravascular stent implants for maintaining vascular patency in humans and animals and more particularly to a stent in the form of a double wave stent with strut. BACKGROUND OF THE INVENTION Percutaneous transluminal coronary angioplasty (PTCA) is used to increase the lumen diameter of a coronary artery partially or totally obstructed by a build-up of cholesterol fats or atherosclerotic plaque. Typically a first guidewire of about 0.038 inches in diameter is steered through the vascular system to the site of therapy. A guiding catheter, for example, can then be advanced over the first guidewire to a point just proximal of the stenosis. The first guidewire is then removed. A balloon catheter on a smaller 0.014 inch diameter second guidewire is advanced within the guiding catheter to a point just proximal of the stenosis. The second guidewire is advanced into the stenosis, followed by the balloon on the distal end of the catheter. The balloon is inflated causing the site of the stenosis to widen. The dilatation of the occlusion, however, can form flaps, fissures and dissections which threaten reclosure of the dilated vessel or even perforations in the vessel wall. Implantation of a metal stent can provide support for such flaps and dissections and thereby prevent reclosure of the vessel or provide a patch repair for a perforated vessel wall until corrective surgery can be performed. It has also been shown that the use of intravascular stents can measurably decrease the incidence of restenosis after angioplasty thereby reducing the likelihood that a secondary angioplasty procedure or a surgical bypass operation will be necessary. An implanted prosthesis such as a stent can preclude additional procedures and maintain vascular patency by mechanically supporting dilated vessels to prevent vessel reclosure. Stents can also be used to repair aneurysms, to support artificial vessels as liners of vessels or to repair dissections. Stents are suited to the treatment of any body lumen, including the vas deferens, ducts of the gallbladder, prostate gland, trachea, bronchus and liver. The body lumens range in diameter from small coronary vessels of 3 mm or less to 28 mm in the aortic vessel. The invention applies to acute and chronic closure or reclosure of body lumens. A typical stent is a cylindrically shaped wire formed device intended to act as a permanent prosthesis. A typical stent ranges from 5 mm to 50 mm in length. A stent is deployed in a body lumen from a radially compressed configuration into a radially expanded configuration which allows it to contact and support a body lumen. The stent can be made to be radially self-expanding or expandable by the use of an expansion device. The self expanding stent is made from a resilient springy material while the device expandable stent is made from a material which is plastically deformable. A plastically deformable stent can be implanted during a single angioplasty procedure by using a balloon catheter bearing a stent which has been crimped onto the balloon. Stents radially expand as the balloon is inflated, forcing the stent into contact with the interior of the body lumen thereby forming a supporting relationship with the vessel walls. The biocompatible metal stent props open blocked coronary arteries, keeping them from reclosing after balloon angioplasty. A balloon of appropriate size and pressure is first used to open the lesion. The process is repeated with a stent crimped on a second balloon. The second balloon may be a high pressure type of balloon, e.g., more than 12 atmospheres, to insure that the stent is fully deployed upon inflation. The stent is deployed when the balloon is inflated. The stent remains as a permanent scaffold after the balloon is withdrawn. A high pressure balloon is preferable for stent deployment because the stent must be forced against the artery's interior wall so that it will fully expand thereby precluding the ends of the stent from hanging down into the channel encouraging the formation of thrombus. Various shapes of stents are known in the art. They may be a wire stent or a tubular stent and configured with or without struts. Prior art stents have struts and crossovers which are typically welded or formed integrally with the stent or permit only a limited range of movement. Such struts or crossovers may have more structural radial stiffness and lack flexibility in tortuous anatomies. Due to the dynamic motions of the arteries during the cardiac cycles, especially coronary arteries, stiffer stents may be more prone to fatigue and fracture. U.S. Pat. No. 4,856,516 to Hillstead for "Endovascular Stent Apparatus and Method" discloses a wire first bent into a series of tight bends. The wire is then further bent into a sequence of loops that are connected by half hitch junctions and interconnections which are either aligned or spiral around the circumference of the stent. U.S. Pat. No. 4,878,906 to Lindemann et al. for "Endoprosthesis for Repairing a Damaged Vessel" discloses a flexible, plastic, thin-walled sleeve molded with various types of circumferential and axial ribs and reinforcements to be used as an endovascular prosthesis. FIGS. 3, 5, 6, 8, and 9 disclose a fixed axial rib. U.S. Pat. No. 4,886,062 to Wiktor for "Intravascular Radially Expandable Stent and Method of Implant" discloses a two-dimensional zig-zag form, typically a sinusoidal form and without longitudinal struts. U.S. Pat. No. 4,994,071 to MacGregor for "Bifurcating Stent Apparatus and Method" discloses a wire forming a backbone extending axially along the length of the lattice that extends away from the lattice and is used to construct the interconnecting loops. A series of generally parallel oriented loops interconnected by a sequence of half-hitch connections extend along an axial dimension. U.S. Pat. No. 5,061,275 to Wallsten for "Self-Expanding Prosthesis" discloses a number of elements having the same direction of winding but being axially displaced relative to each other and crossing a number of elements also axially displaced relative to each other but having the opposite direction of winding to form a braided structure. U.S. Pat. No. 5,104,404 to Wolff for "Articulated Stent" discloses a stent made up of a number of wires welded together and then connected together with hinges to provide articulation. U.S. Pat. No. 5,133,732 to Wiktor for "Intravascular Stent" discloses a stent body coiled from a generally continuous wire with a deformable zig-zag structure with a means for preventing the stent body from stretching along its longitudinal axis. A longitudinal wire is attached, preferably by welding to waves of wire at points. U.S. Pat. No. 5,135,536 to Hillstead for "Endovascular Stent and Method" discloses locations permanently adhered together to form junctions which are generally aligned to form a backbone. Filament portions at each end and location 24 are permanently adhered together to form junctions to prevent the unrolling of the stent. U.S. Pat. No. 5,195,984 to Schatz for "Expandable Interluminal Graft" discloses a plurality of slots disposed substantially parallel to the longitudinal axis of the tubular members, and adjacent grafts are flexibly connected by a single connector member disposed substantially parallel to the longitudinal axis of the tubular members. Connector members are preferably formed of the same material as grafts and may be formed integrally between adjacent grafts. The end turn of the helix is welded and intermediate welds are formed to stabilize the length of the helix. U.S. Pat. No. 5,389,106 to Tower for "Impermeable Expandable Indovascular Stent" discloses a pigtail that is passed back along the circumferential sections and is joined to the other end section. Commonly owned co-pending U.S. Ser. No. 08/633,394 to Boyle for "Joined Sinusoidal Helix Stent" discloses a sinusoidal wave stent which aligns at the off peak to the off valley adjacent locations with a pattern of welds affixing the alignment locations to each other. Commonly owned co-pending U.S. Ser. No. 08/563,715 to Boyle et al. for "Interwoven Dual Sinusoidal Helix Stent" discloses braided peaks and valleys forming a braided region. What is needed is a flexible stent design which overcomes the prior art inflexibility resulting from welding or twisting junctions at the crossovers of wires yet does not lengthen or shorten when used in tortuous anatomies and which has good coverage without being prone to fracture or fatigue as a result of repeated flexions with an artery. SUMMARY OF THE INVENTION The present invention is accomplished by providing a radially expandable stent for implantation within a body vessel, comprising a first and second elongated element having a series of peaks alternating with valleys forming a wave shape therein. The first elongated element is interwoven with the second elongated element in a series of crossovers, with each crossover forming a symmetrical intersection and each successive pair of crossovers defining a loop. The interwoven first and second elongated elements are wound into a hollow cylindrical shape with at least one longitudinal strut extending parallel to a longitudinal axis of the hollow cylindrical shape and passing through at least one of the loops along the hollow cylindrical shape. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of a first wire segment; FIG. 2 is a plan view of a first and second wire segment showing four crossovers; FIG. 3 is a plan view of a stent of the present invention mounted on a balloon catheter; and FIG. 4 is an enlargement of area 4 of FIG. 3. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The double wave stent is designed to be flexible and to have high fatigue and fracture resistance while at the same time conforming to the dynamic motions of the arteries. It also avoids lengthening and shortening of the stent upon expansion. Applicant's crossovers 75 are not fixed points between the first wire segment 15 and the second wire segment 25. Strut 20 is affixed only at its proximal and distal end. This lack of fixation reduces the possibility of fracture and fatigue while increasing stent flexibility in tortuous anatomies. A typical stent is formed with a wire segment which is formed into a sinusoidal wave form helix pattern the length of the stent by a means such as passing the wire through gears such as those disclosed in U.S. Pat. No. 2,153,936 issued to Owens et al. As shown in FIGS. 1 and 2 a first wire segment 15 and a second wire segment 25 are formed into a sinusoidal wave form Helix pattern. The first wire segment 15 is crossed over the second wire segment 25 at a point midway between a peak 60, 70 and valley 55, 65 Each peak 60, 70 and valley 55, 65 pair form a wave 30. The valleys of the first wire segment 15 are aligned along the same longitudinal axis as the valleys of the second wire segment 25. The peaks of the first wire segment 15 are aligned along the same longitudinal axis as the peaks of the second wire segment 15. The crossovers 75 of the first wire segment 15 alternate going over and under the second wire segment 25. The first wire segment 15 and the second wire segment 25 are not affixed to each other at crossovers 75. Unlike the prior art with welded or twisted crossovers, the wires are able to slide over each other causing less fatigue and potential fracture as arteries such as the coronary arteries flex. After the crossovers 75 are created, the helix is wound in barber pole fashion over a cylindrical form such as a mandrel. The present invention shown in FIG. 3, depicts a radially expandable stent 10 in the form of a hollow cylinder defined by a sequence of wire elements 40a-f with each of the wire elements 40a-f extending 360 degrees around the cylinder. A peak 60, 70 and valley 55, 65 pair constitute a wave. Three to four waves per 360 degree revolution constitute an element 40 and are preferred for coronary applications. Applicant's invention is not limited to coronary applications, however, and can, for example, be used in peripheral and other applications. Those skilled in the art would recognize that the number of waves per revolution depends on the diameter of the stent and the desired stiffness. The wire elements 40a-f have extendible, sinusoidal zig-zags formed by smooth bends such as alternating peaks 60 and valleys 55. As shown, the peaks 60 and valleys 55 are shaped in a generally longitudinal direction along the cylinder at one point and then reverse their direction so that the peaks 60 and valleys 55 may open as the wire element 40a is expanded. Also as shown, the wire elements 40a-f are uniformly spaced along the cylinder and the peaks 60 and valleys 55 are uniformly spaced around the cylinder. The adjacent wire elements 40a-f are flexibly connected together in an end-to-end fashion by means of helical winding. The wire elements 40a-f have a plurality of extendible portions, such as peaks 60 and valleys 55 which permit the wire elements to be expanded from a first diameter covering 360 degrees of the cylinder to a second, expanded diameter covering 360 degrees of the expanded cylinder. A typical coronary stent may have the following dimensions. The stent wire 15 can have a diameter of about 0.001 inches to about 0.015 inches. The preferred form of the sinusoidal wave of the wire segment is a length of about 0.150 inches to about 0.090 inches and a wave amplitude of between about 0.050 inches and about 0.080 inches. Any wave length and amplitude combination that would provide adequate vessel 50 hoop strength and vessel 50 coverage is appropriate. The stent 10 must expand evenly and permit the balloon 35 to expand evenly. The stent 10 of this invention and balloon can be transported via a standard #7 or #8 French guiding catheter. Once on location, the stent 10 can be expanded radially by the expansion of the balloon 35; a ratio of 2.75:1 can be achieved with a wire diameter of approximately 0.005 inches and an initial stent diameter of 0.060 approximately inches. A forming mandrel sequence can provide a gradual reduction in the stent 10 outer diameter by the use of applied finger pressure under microscopic observation. For a coronary sized stent it is possible to go directly from a 0.150 inch stent outer diameter to a 0.065 inch stent outer diameter by placing stent 10 directly onto the balloon 35 from the forming mandrel and make an acceptable stent, but it is more difficult to maintain proper alignment of the stent wires by doing so. Thus it is preferred that the stent 10 is further processed from a 0.150 inch diameter forming mandrel by pressing it onto a 0.100 inch diameter forming mandrel, thereafter pressing it onto a 0.080 inch diameter forming mandrel and finally pressing it onto a 0.065 inch diameter forming mandrel before being applied to the balloon 35. Those skilled in the art would recognize that a variety of acceptable mandrel sizes could be used in the forming sequence depending on the desired stent size. After the stent 10 has been reduced to the objective outer diameter, the stent is terminated as follows. The proximal end of the first wire segment 15 is attached to the second wire segment 25. The proximal end of the second wire segment is attached to the closest adjoining element 40-a. The distal end of the first wire segment 15 is attached to the second wire segment 25. The distal end of the second wire segment is attached to the closest adjoining element 40-f. Strut 20 is affixed by attaching the proximal end to a location on the second wire segment 25 distal to the first wire segment proximal loop attachment 45 to form the strut proximal loop attachment 90. The distal end of strut 20 is threaded through loops 100 parallel to the longitudinal axis of the stent 10. The distal end of strut 20 is then attached to a location on the second wire segment 25 distal to the first wire segment distal loop attachment 80 to form the strut distal loop attachment 95. The proximal end of the first wire segment 15 is terminated by affixing it to the second wire segment 25 to form the first wire segment proximal loop attachment 45. The distal end of the first wire segment 15 is terminated by affixing it to the second wire segment 25 to form the first wire segment distal loop attachment 80. The second wire segment 25 proximal end is terminated by affixing it to the closest adjoining element 40a to form the second wire segment proximal loop attachment 50. The second wire segment 25 distal end is terminated by affixing it to the closest adjoining element 40f to form the second wire segment distal loop attachment 85. The attachments 45, 50, 80, 85, 90 or 95 could be done by manually looping them. Those skilled in the art will recognize other means of end attachments which include twisting, biocompatible adhesive, brazing, crimping, welding or stamping. The strut 20 can be attached either before or after the forming mandrel sequence. It is however, easier to form the strut after the forming mandrel sequence has reduced the stent 10 to its objective size. Applicant's strut 20 is free to move within loops 100 with the dynamics of artery movement thereby resulting in less fatigue and fracture potential. Prior art struts which are welded or integral have more structural radial stiffness but lack flexibility in tortuous anatomies. The stiffer the stent, the more prone it is to fatigue and fracture. Applicant's strut 20 is not affixed except at the proximal and distal ends. It is free to flex in tortuous anatomies yet provides additional coverage. Applicant's strut 20 controls longitudinal deformation by resisting shortening or elongation of the stent 10 during expansion or compression because it is affixed at its proximal and distal ends. The free floating strut 20 slides freely between waves 30 yet adds radial (hoop) stiffness. Additional longitudinal stiffness and arterial support can be achieved by adding additional struts 20 through a series of loops 100 running longitudinally throughout the stent 10. The balloon expandable stent 10 can be made of an inert, biocompatible material with high corrosion resistant that can be plastically deformed at low-moderate stress levels such as tantalum, the preferred embodiment. Other acceptable materials include stainless steel, titanium ASTM F63-83 Grade 1, niobium or high carat gold K 19-22. A self-expanding device can be made by the use of superelastic (nickel titanium) NiTi such as Nitinol manufactured by Raychem or Forukawa. The struts 20 can be made of a different material and/or be of a different diameter than the first wire segment 15 and second wire segment 25. After formation, the stent 10 is placed over a suitable expandable diameter device such as an inflatable balloon 35 which is typically used for angioplasty procedures. A stent can be implanted during a single angioplasty procedure by using a balloon catheter bearing a stent 10 which has been crimped by hand or with a suitable crimping tool (not shown) onto balloon 35. Manually squeezing the stent 10 over the balloon 35 is also acceptable. The stent 10 is radially expanded as the balloon 35 is inflated, causing the stent 10 to contact the body lumen thereby forming a supporting relationship with the vessel walls. As the balloon 35 expands, so does the stent 10. The expanding balloon 35 together with the stent 10 compresses the plague in the stenosis and prevent possible reocclusion. When the angioplasty procedure is completed, the balloon 35 is deflated and withdrawn leaving the stent 10 firmly implanted within the vessel. The previously occluded vessel is recannalized and patency is restored. Any protrusions are undesirable because they are conducive to turbulent blood flow and potential formation of thrombosis. The stent 10 is centrally located and positioned with respect to the length of balloon 35. The stent 10 turns are evenly spaced so that when the stent 10 is expanded, the stent 10 will provide even support inside the vessel and resist external loading. The preceding specific embodiments are illustrative of the practice of the invention. It is to be understood, however, that other expedients known to those skilled in the art or disclosed herein, may be employed without departing from the scope of the appended claims. ______________________________________No. Component______________________________________10 Stent15 First Wire Segment20 Strut25 Second Wire Segment30 Wave35 Balloon40a-f Element45 First Wire Segment Proximal Loop Attachment50 Second Wire Segment Proximal Loop Attachment55 Valley First Wire Segment60 Peak First Wire Segment65 Valley Second Wire Segment70 Peak Second Wire Segment75 Crossover80 First Wire Segment Distal Loop Attachment85 Second Wire Segment Distal Loop Attachment90 Strut Proximal Loop Attachment95 Strut Distal Loop Attachment100 Loop______________________________________

A radially expandable stent for implantation within a body vessel, comprising a first and second elongated element having a series of peaks alternating with valleys forming a wave shape therein. The first elongated element is interwoven with the second elongated element in a series of crossovers, with each crossover forming a symmetrical intersection and each successive pair of crossovers defining a loop. The interwoven first and second elongated elements are wound into a hollow cylindrical shape with at least one longitudinal strut extending parallel to a longitudinal axis of the hollow cylindrical shape and passing through at least one of the loops along the hollow cylindrical shape.

BACKGROUND OF THE INVENTION This invention relates generally to butchering machinery, and more particularly to an apparatus for cutting wings from poultry. Poultry butchering is increasingly automated. There is a wide variety of machinery from which to choose to perform any number of butchering chores, from plucking to deboning. Such devices have made high-volume processing a reality, while relieving people from a number of unpleasant chores. Butchering machines have the advantage of consistency and tirelessness, but generally are not as adaptable as their human counterparts to changing situations. One way of improving the adaptability of machines is to make them modular, that is, readily replaced stand-alone devices. Modularity also gives the packer flexibility in terms of the cuts he can produce. There are already many different devices for removing wings and cutting the wings into segments (drumette, flat and wing tip). Perhaps the most difficult cut is at the shoulder, where the anatomy is complex and the exact location of the joint is not so easy to see. A knife or other flat blade has typically been used to sever the joint. SUMMARY OF THE INVENTION An object of the invention is to enable poultry producers to produce clean, attractive arcuate cuts at the shoulder joint when removing wings from breasts, so as to enhance the appearance and consistency of both parts Another object of the invention is to keep from producing bone chips when removing poultry wings. A further object of the invention is to automate fully the cutting up of poultry wings, into three segments. These and other objects are attained by an apparatus for cutting wings from boned whole poultry breasts includes a pair of spaced chain loops supporting laterally aligned pairs of fixtures which both hold the wings to support the breasts and served as anvils for annular knife blades which are driven outward from a central position to cut the breasts from the wings. Thereafter, the wings remain secured in the fixtures, while first the tips are removed by a guillotine-type cutter, and then the flat is folded against the drumette before the elbow joint is cut. The various pieces fall onto respective conveyors for subsequent packaging. BRIEF DESCRIPTION OF THE DRAWINGS In the accompanying drawings, FIG. 1 is a diagrammatic side view of a machine embodying the invention; FIG. 2 is a sectional view, looking upstream on plane 2--2 in FIG. 1, showing a shoulder cutting device; FIG. 3 is a side elevation of the rotary cutter shown in FIG. 2; FIG. 4 is an oblique view of a portion of the machine in which the lower wing joints are severed, and FIG. 5 is a side view of one of the poultry wing support fixtures shown in FIG. 2. DESCRIPTION OF THE PREFERRED EMBODIMENT The general layout of a machine embodying the invention is shown in FIG. 1. The machine includes a frame 10 (FIG. 2) to which bearings are attached for supporting two shafts 14,16 on which respective pairs of sprockets 18,20 are mounted. Conveyor chains 22 run on the sprockets. The chains are about eight inches apart. One of the shafts, preferably the downstream one 16, is driven intermittently by a motor 24 through a speed reduction unit. The chains are caused to index a fixed distance, such as seven and a half inches, each cycle. Each chain is supported from below, along its top run, by the broad edge of a vertical UHMW (ultra-high molecular weight polyethylene) plate 30. The chain slides along this edge, and is kept aligned with it laterally by a series of tabs 32, welded to the chain's link plates, facing the interior of the loop. The inwardly facing tabs 32 straddle the UHMW plate on either side. The chain also has outwardly facing tabs 34, having holes through which bolts are passed to secure specially shaped UHMW fixtures 36 for supporting the wings of a deboned breast--one from which the rib cage has been removed. Each fixture 36, as shown in FIG. 5, is substantially a rectangular block transected by a large central recess 38 having a "U" shape. The width of the recess is sufficient to receive the upper segment or "drumette" of a chicken wing, i.e., the segment containing the humerus, but its width is smaller than the diameter of the shoulder ball. A smaller slot 40 is cut lengthwise into the top of the block, intersecting the transverse groove 38. A mounting boss protrudes from the block, and fits between a pair of the outwardly protruding chain tabs 34, to which it is bolted. A circular groove 41, about 1/4 inch wide by 3/8 inch deep, and having a mean diameter substantially equal to that of the annular blade, encircles the bottom of said recess, so that the blade can enter the groove, to insure that the blade completely severs the shoulder. A metal bar 42 is affixed to the frame above each chain loop, and within the slot 40 of each fixture. The bar, and the plate 30, constrain the fixture to move only within a vertical plane, and prevent it from rocking sideways. The bar confines the wing from above, so that it cannot escape from the fixture. Now, at the upstream end of the device, there is a loading station where a whole, boned chicken breast is transferred by seating the wings in the recesses fixtures. The fixtures hold the humeri so that their exposed shoulder ends are aligned horizontally. Just downstream of the loading station, the wings enter under the constraining bars 42, which thereafter hold them in the recesses. The unsupported breast meat, having no skeleton by now, sags sufficiently between the wings that it can pass beneath a pair of annular-blade cutters 44. Each cutter 44 is slidingly supported on a pair of fixed, parallel, horizontal rods (not shown) extending transverse to the chains and above them. Each cutter has a metal housing 50 affixed to a UHMW block 52 which acts as a sliding bearing for the rods. The rods, each about a foot long, is mounted between brackets 54 which are affixed to the channels 42. Outboard of the brackets are opposed double-acting linear motors 56 (pneumatic cylinders). In each motor, the cylinder 58 proper is affixed to the bracket 54, while its piston rod 60 is affixed to the cutter housing. Air to operate the cylinder is controlled by a valve (not shown) which is operated in synchronization with the chain drive motor. Each cutter housing 62 has an enlarged head to which a hydraulic rotary motor 64 is attached. The motor has an inlet, fed from an intermittently pressurized supply line 66, and an outlet to which a return line 68 is connected. The motor drives an annular blade 70 through a train of gears 72 within the housing. The lowermost gear is a ring gear 74 extending around the annular blade. The blade's cutting edge protrudes from the housing in one direction (away from the other cutter device) about an inch, toward one of the fixtures, which acts as an anvil. Each annular blade has an inside diameter of about 1.75 inch and wall thickness of about 0.125 inch, and is internally beveled to a sharp edge. The interior of the blade is completely open, and its axis is substantially aligned with the humerus of one of the wings at a dwell position of the breasts. The wings are severed from the breasts when the cutters are driven outward--with the blades rotating at about 800 rpm--away from the position illustrated in FIG. 2, by the linear motors 56. The exposed portion of each annular blade extends through a somewhat larger hole in a stripper plate 80 whose upper end is pivotally secured to the upstream face of the housing by a bolt 81, and which is biased by a spring so that its lower portion, surrounding the annular blade, tends toward a position just outboard of the cutting edge. When the blade is actually cutting, the breast meat forces the stripper inward toward the housing; when cutter is retracted, the stripper pushes any accumulated flesh off the blade. Just downstream of the shoulder cutters are a pair of wing tip cutters 82, each comprising a knife 94 mounted on a horizontal UHMW plate 86 whose lateral edges are received in respective fixed metal U-channels 88 so that the plate can slide freely perpendicular to the center plane of the machine. The plate is reciprocated by a crank arm 90 driven by a motor (not shown) within the machine. The crank tip has a stroke of about seven inches, and is linked to the plate by a pin extending through a slot at the outboard end of the plate. The plate 86 itself has pair of fingers 104 on either side of a gap 92 at the end opposite the crank, and the knife 94 is installed within this slot. The knife comprises a half-inch diameter rod 94 whose nose 96 is rounded and bent downward about 20°, below the upper surface of the plate. A sharp, vertical blade 98, angled rearward like a shark's fin, is secured in a narrow slot 100 running lengthwise of the rod. When the wing tip cutter knife is driven inward by the crank 90, the fingers and the knife 84 extend through matching-geometry holes in a UHMW anvil 102, mounted to the frame just outside the conveyor chains. The fingers 104 of the plate enter the smaller holes 106, while the knife (rod and blade) enters the central slot 108. The wing tip, now outside the anvil, cannot pass through the slot, and hence is severed from the rest of the wing. At the downstream end of the machine, there is an elbow cutter 110, which separates the two upper wing segments, the flat and the drumette, from one another. The elbow cutter comprises a horizontal stationary blade 112, mounted on the machine frame and extending away from the center plane of the machine, in the path of the elbow. Upstream of the blade, there are means for bending the elbow preparatory to cutting. The preferred bending means comprises a fixed round bar 114, around which the elbow is bent, and a horizontal folding plate 116 mounted for oscillation on a vertical pivot shaft 118 about ten inches from the center plane. The shaft is turned by a pneumatic cylinder (not shown) driving a lever arm at the bottom of the shaft. The folding plate has a curved inner edge 122, whose bottom edge is beveled, as indicated by the broken line in FIG. 4. The contour of the curved edge is designed so that, as the plate pivots inward, the force applied to the wing is always in the transverse direction. This way, the wing does not get deflected upstream or downstream as it is bent. When rotated fully inward, the curved inner edge 122 seats against a similarly curved rest 124 attached to the machine; this extends the "ceiling" provided by the folding plate. As the wing (still held firmly by the fixture, and now consisting of only the upper two segments) approaches the blade 112, it is bent sharply around the round bar as the folding plate is driven inward. This bending stresses the elbow, which helps produce a clean cut. Just upstream of the outward-facing blade 112, there is an inward-facing blade 126, which is also stationary and makes a preliminary cut or nick in the outside of the elbow, to allow the joint to separate somewhat. The bar 114 also accurately positions the elbow with respect to the blade, so that the blade cuts between the bones, rather than through either of them. We have not shown or described means for receiving the various parts of the chicken as they are cut, but it should be understood that as each cut is made, one part falls onto a conveyor, or into a bin, for subsequent processing. The diameter of the annular blades is not critical, other than that it must be sufficiently great to clear the humerus reliably, as bone chip production is to be avoided. The size selected may depend on a number of factors including the size of the birds being butchered, and the preferences of the packer. Since the invention is subject to modifications and variations, it is intended that the foregoing description and the accompanying drawings shall be interpreted as illustrative of only one form of the invention, whose scope is to be measured by the following claims.

An apparatus for cutting wings from boned whole poultry breasts includes a pair of spaced chain loops supporting laterally aligned pairs of fixtures which hold the wings to support the breasts and serve as anvils for annular knife blades which are driven outward from a central position to cut the breasts from the wings. Thereafter, the wings remain secured in the fixtures, while first the tips are removed by a guillotine-type cutter, and then the flat wing segment is folded against the drumette before the elbow joint is cut.

[0001] This application claims priority from U.S. provisional patent application 60/956,089, filed Aug. 15, 2007. FIELD OF THE INVENTION [0002] The present application relates generally to brush devices for grasping and manipulating tissue particularly for natural orifice surgery. BACKGROUND OF THE INVENTION [0003] The present assignee's U.S. patent publication no. 2007/0225734 and U.S. patent application Ser. No. 11/788,597, both of which are incorporated herein by reference, disclose various natural orifice surgery systems and methods for resolving maladies such as diverticulosis and appendicitis and for removing organs such as the gall bladder. The present application is directed to structures and methods for inverting tissue particularly in connection with natural orifice surgery to facilitate the resolution of the tissue. SUMMARY OF THE INVENTION [0004] An apparatus includes a tissue gripping element housed within a tubular member for advancement through a natural orifice to tissue to be inverted pursuant to resolution of a malady associated with the tissue. The tissue gripping element is advanceable out of the tubular member into the tissue to grip the tissue and is retractable into the tubular member to grip the tissue for manipulation of the tissue. The tissue gripping element includes plural discrete gripping points. [0005] In some embodiments the gripping points can be established by ends of respective bristles oriented generally radially relative to the tubular member. In other embodiments the gripping points are established by ends of respective teeth. The teeth may be arranged on a proximal-facing transverse surface, and plural tubular member teeth can be arranged on a distal-facing transverse surface of the tubular member. The tissue gripping element is distally advanceable relative to the tubular member to space the surfaces from each other and is proximally retractable relative to the tubular member to trap tissue between the surfaces. [0006] The tubular member may establish a vacuum lumen through which a vacuum can be drawn to attract tissue toward the tubular member. Tissue can be attracted toward an open distal end of the tubular member when a vacuum is drawn in the tubular member, and in some embodiments tissue can also be attracted toward plural vacuum openings formed in the tubular member when a vacuum is drawn in the tubular member. A cover tube may be advanced over the tubular member to block at least some of the vacuum openings. [0007] If desired, the tissue gripping element can be rotatable relative to the tubular member. Also, a smooth rounded atraumatic surface can be provided for establishing a distal end of the tissue gripping element. [0008] In another aspect, a method includes establishing a retracted configuration of a tissue manipulation device in which a tissue gripping element is retracted entirely within a sleeve. The tissue gripping element includes plural discrete gripping points. The method also includes providing instructions to advance the tissue manipulation device through a natural body orifice to tissue to be manipulated, providing instructions to advance the tissue gripping element out of the sleeve, and providing instructions to manipulate the tissue gripping element to grip tissue. Instructions to retract the tissue gripping element toward the sleeve can also be provided. [0009] In another aspect, a system includes a delivery tube advanceable into a natural body orifice toward tissue to be manipulated and an elongated control rod extending from a proximal end of the tube and manipulable by a person. A tissue gripping element is coupled to the control rod and is advanceable out of a distal end of the delivery tube. The gripping element includes plural individual grippers configured to engage tissue and thereby provide a means for manipulating the tissue by manipulating the control rod. [0010] The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which: BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 is a perspective partially schematic view of a tissue inversion apparatus, with portions broken away; [0012] FIG. 2 is a perspective view of the distal end of an alternate tissue inversion apparatus in the extended position; [0013] FIG. 3 is a perspective view of the distal end of a tissue inversion apparatus in the housed position for advancing the brush toward tissue to be inverted; [0014] FIG. 4 is a perspective view of the distal end of the tissue inversion apparatus of FIG. 3 , with the brush in the extended position in tissue to be inverted and after a vacuum has been established; [0015] FIG. 5 is a perspective view of the distal end of the tissue inversion apparatus of FIG. 4 , with the brush retracted part way back into the sleeve to trap tissue; [0016] FIGS. 6-8 are perspective views of the distal segments of non-limiting implementations of brush inversion apparatus; [0017] FIGS. 9-12 are schematic diagrams of the distal portion of an alternate tissue inversion apparatus showing how tissue is clamped between opposed jagged surfaces; and [0018] FIG. 13 is a perspective view of the distal segment of yet another non-limiting implementation of brush inversion apparatus. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0019] Referring initially to FIG. 1 , a system is shown, generally designated 10 , that includes a flexible elongated hollow sleeve-like delivery tube 12 that is advanceable into a natural body orifice such as the mouth or anus toward tissue to be manipulated. If desired, at least a distal sleeve 14 of the delivery tube 12 may be configured with plural vacuum openings 16 such as round holes, elongated slots, etc. as more fully disclosed below. The openings 16 may establish a spiral pattern as shown. [0020] As shown in FIG. 1 , the delivery tube 12 may terminate proximally at a “wye” connector 18 , one branch of which supports a manipulable elongated control rod 20 around which a collet 22 may be tightened to prevent movement of the rod 20 relative to the “wye” 18 . The other branch of the “wye” forms a lumen that may be connected to a pressure source 24 . The pressure source 24 may be a negative pressure source (a vacuum) or a positive pressure source (such as a fluid pump or pressurized fluid source) for establishing a desired pressure within the delivery tube 12 . [0021] As also shown in FIG. 1 , a tissue gripping element 26 is coupled to the control rod 20 and is advanceable out of an open distal end 28 of the delivery tube 12 . In the embodiment shown in FIG. 1 , the tissue gripping element 28 includes plural individual, discrete grippers 30 such as brush bristles that are configured to engage tissue and thereby provide a means for manipulating the tissue by manipulating the control rod 20 . At least some of the bristles may be oriented generally radially relative to the delivery tube 12 as shown. If desired, a cover tube 32 may be advanceable over the delivery tube to block at least some of the vacuum openings 16 . [0022] FIG. 2 shows that in some implementations, a smooth rounded atraumatic surface 34 may be provided on the distal end of the tissue gripping element 26 to facilitate advancing the gripping element 26 into tissue atraumatically to the tissue. [0023] FIGS. 3-5 illustrate various operational configurations of the system 10 . In FIG. 3 , the gripping element 26 is retracted within the sleeve 14 with no part of the gripping element 26 extended distally beyond the open distal end of the sleeve. In this configuration, the sleeve 14 with gripping element 26 may be advanced through the natural orifice to the tissue sought to be manipulated, such as, e.g., the appendix, gall bladder, diverticulum, etc. [0024] Once the sleeve 14 is juxtaposed with the tissue, as shown in FIG. 4 the gripping element 26 is advanced by means of the control rod 20 out of the distal end of the sleeve 14 and into tissue 36 , typically into a void that is naturally formed by the tissue. If desired, the interior of the sleeve 14 may be evacuated by appropriately operating the source 24 of pressure shown in FIG. 1 to attract the tissue 36 toward the sleeve 14 , including toward the vacuum openings 16 and the open distal end of the sleeve. Evacuation also causes the tissue to collapse onto the grippers 30 , with the ends of a multitude of grippers establishing anchor points to the tissue. In addition to vacuum or alternatively, the gripping element 26 may be rotated to tighten the tissue onto the grippers 30 . In any case, adequate time may be allocated to permit the vacuum to collapse the tissue. [0025] By providing multiple points of contact (e.g., multiple bristles), less damage to the tissue is effected during manipulation and furthermore, minimally traumatic disengagement of the gripping element 26 with the tissue should such become necessary is facilitated. To disengage the tissue, a positive pressure source may be actuated to pressurize the interior of the sleeve 14 and thereby urge tissue away from the sleeve and bristles. [0026] As shown in FIG. 5 the gripping element 26 may be retracted proximally relative to the sleeve 14 to trap or wedge the tissue 36 between the grippers 30 and the interior of the sleeve 14 as shown. With the tissue thus firmly gripped, it may be manipulated as desired, e.g., the tissue may be inverted, moved, retracted, resected, etc. as appropriate for the particular procedure. Instructions may be provided on, e.g., a substrate to effect the above steps. [0027] FIG. 6 shows that in one non-limiting implementation, a brush 40 with plural generally radially oriented and relatively rigid bristles may be engaged with a delivery tube 42 formed with plural vacuum holes 44 . The diameter “D 1 ” of the brush 40 may be 2.3 mm and the brush may be 20 mm in length. The brush 40 may slide within the tube 42 or it may be stationarily engaged with the tube 42 , in which case a cover tube such as the cover tube 32 shown in FIG. 1 that can be made of, e.g., Teflon™ can be used to enclose the brush 40 during delivery to the tissue site. [0028] FIG. 7 shows that in another non-limiting implementation, a brush 46 with plural generally radially oriented and relatively rigid bristles may be engaged with a delivery tube 48 formed with plural elongated vacuum notches 50 that do not extend completely through the wall of the tube 48 but that terminate in respective vacuum holes 52 that do extend through the wall of the tube. The notches 50 with holes 52 may be formed in two lines on opposite sides of the tube. The diameter “D 2 ” of the brush 46 may be 2.5 mm and the brush may be 25 mm in length. The brush 46 may slide within the tube 48 or it may be stationarily engaged with the tube 48 , in which case a cover tube such as the cover tube 32 shown in FIG. 1 that can be made of, e.g., Pebax™ can be used to enclose the brush 40 during delivery to the tissue site. [0029] FIG. 8 shows that in another non-limiting implementation, a brush 54 with plural generally radially oriented and relatively rigid bristles may be engaged with a delivery tube 56 formed with plural elongated vacuum notches 58 that do not extend completely through the wall of the tube 56 but that terminate in respective vacuum holes 60 that do extend through the wall of the tube. The notches 56 with holes 60 may be formed in two lines on opposite sides of the tube, and additional holes 62 may be formed without notches in a spiral pattern as shown. Tape may be used to cover holes that are not desired to be used to establish a vacuum. The brush can be exposed at various lengths relative to the tube. The hole pattern inhibits tissue slippage to minimize unwanted twisting of the appendix. [0030] FIGS. 9-12 show an alternate system 100 in which a gripping element 102 is slidably engaged with a delivery tube 104 that may be formed with vacuum openings 106 in accordance with disclosure above. As shown, the gripping element 102 includes a rounded smooth atraumatic distal end 108 defining a flat disc-like proximal-facing surface formed with plural teeth 110 . Also, the distal end of the tube 104 defines a distal-facing flat disc-like surface formed with plural tube teeth 112 . [0031] With this structure, the system 100 is advanced through a natural orifice with the gripping element 102 retracted into the tube 104 ( FIG. 9 ) such that the teeth 110 , 112 mesh, or alternatively are in substantial contact with each other. When positioned in the target tissue the gripping element 102 is advanced away from the tube 104 ( FIG. 10 ) into the tissue and then vacuum is established in the tube 104 ( FIG. 11 ) to attract tissue into the space between the teeth 110 , 112 . The gripping element 102 is then retracted proximally relative to the tube 104 ( FIG. 12 ) to trap tissue between the teeth 110 , 112 . The shaft of the gripping element 102 may further include bristles in accordance with the disclosure above in addition to the structure shown in FIGS. 9-12 . [0032] FIG. 13 illustrates a gripping element 200 with bristles 202 and atraumatic distal tip 204 that may be slidably engaged with a sleeve 206 . The sleeve 206 may be formed with vacuum openings 208 . A cover tube 210 such as the cover tube 32 shown in FIG. 1 can be used to enclose the bristles and/or to cover the vacuum openings 208 . [0033] While the particular BRUSH DEVICE FOR GRASPING AND MANIPULATING TISSUE are herein shown and described in detail, it is to be understood that the subject matter which is encompassed by the present invention is limited only by the claims.

A brush-like element can be housed within a vacuum sleeve for advancement through a natural orifice to tissue, such as an appendix or gall bladder or diverticulum, to be inverted pursuant to resolution of a malady associated with the tissue. The brush is advanced out of the sleeve into the tissue and if desired rotated, and vacuum may also be drawn through the sleeve to further grip the tissue. The brush is then retracted into the sleeve to clamp or trap the tissue for inversion or other manipulation.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention generally relates to apparatus for harvesting above-ground food plants, such as fruit or vegetable plants. More particularly, this invention relates to a tailing, or cull recovery system which allows for further recovery of food losses from apparatus for harvesting above-ground food plants. 2. Description of Prior Art Direct-loading harvesters have been known in the art for many years and have enjoyed wide-spread use in the harvesting of above-ground food plants containing food. The above-ground food plants harvested from these direct-loading harvester varies, and may include a variety of above-ground food plants ranging from tomato plants and other fruit plants to cucumber plants and other vegetable plants. Typically, such harvesters are arranged to harvest above-ground food plants grown in rows, to elevate the harvested above-ground food plants to a shaker brush for separating the food on the above-ground foods plants from their vines, to carry the food from the shaker brush to sorter conveyors where unsuitable food and trash are removed, and finally to elevate the remaining food from the harvester to an attendant truck or trailer for delivery to processing plants. Often times, the unsuitable food and trash contain suitable food which is mixed in with the trash for a number of reasons. First, many of the suitable food remains entangled in the vine mass. If suitable food remains entangled in the vine mass the suitable food will fall off the end of the shaker conveyor and onto the ground where the suitable food is regarded as trash. Additionally, some suitable food is lost on the sorter conveyor during the hand sorting process, due to the fact that human hand sorters make mistakes and throw suitable food away. Finally, the color sorters which automatically sort out unsuitable food make mistakes and reject suitable food. This invention provides an improved method and apparatus for recovering food losses from the main recovery system, the handsorters, and the color sorters. This invention provides a recovery shaker conveyor located beneath the main recovery system to catch food and vines which are tossed off the end of the main recovery system. The food and vines are turned over during the fall, thus loosening some food from the vine. The loosened food falls through the openings in the recovery shaker conveyor onto a recovery cross conveyor which is situated in between the chains of the recovery shaker conveyor and under the color sorters. Food which is rejected by the color sorters also falls onto the recovery cross conveyor and is directed toward a dirt sorter electronic system. In another embodiment of this invention, unsuitable food which is pulled as culls by the handsorters, is placed on a recovery sorter conveyor which is fed into the recovery cross conveyor for re-examination. The dirt, debris, and unsuitable food fall off the recovery cross conveyor through the dirt sorter electronic system to the ground. The remaining food is retrieved by the dirt sorter electronic system onto a recovery feed conveyor which drops the remaining food onto the discharge conveyor, where the food is elevated and discharged into a receiving truck. BRIEF DESCRIPTION OF THE DRAWINGS The above-mentioned and other features and objects of this invention will be better understood from the following detailed description taken in conjunction with the drawings wherein: FIG. 1 is a perspective view of a tomato harvester using a preferred embodiment of the invention. FIG. 2 is a schematic representation of a tomato harvester using a preferred embodiment of the invention, illustrating the paths taken by the tomatoes, vines and debris after they are harvested. FIG. 3 is a central section of part of the harvester illustrated in FIGS. 1 and 2. FIG. 4 is a cross-sectional view along lines 4 — 4 in FIG. 3 . DESCRIPTION OF PREFERRED EMBODIMENTS FIG. 1 shows a harvester for harvesting above-ground food plants, according to one preferred embodiment of this invention. While the harvester may be used to harvest a variety of above-ground food plants containing either fruits or vegetables, a tomato harvester H for harvesting tomato plants will be used to describe one preferred embodiment of this invention, as illustrated in FIG. 1 . The tomato harvester H is adapted to harvest tomatoes T from vines V grown in a row on an elongated planting ridge PR. The harvester H is designed to proceed along the planting ridge PR, sever the tomato vines V at ground level, elevate the vines V for further processing, separate the tomatoes T from the vines V, and transfer the tomatoes T to an awaiting truck TR. The harvester H includes a pickup mechanism PU comprising a header conveyor 17 mounted in a header frame 18 , said header frame 18 being pivotally attached to the main frame of the harvester H. The front end of the header frame 18 is supported by a pair of wheels 20 mounted on a U shaped support frame 21 which is pivotally attached to the front end of said header frame 18 . A pair of lever arms 23 extend upward from the U-shaped support frame 21 and are adapted to raise and lower said U-shaped support frame 21 with respect to the front end of the header frame 18 . A pair of hydraulic piston and cylinder assemblies 24 are attached to the distal ends of the lever arms 23 at the piston rod and to the header frame 18 at the cylinder end. Actuation of the hydraulic piston and cylinder assemblies 24 allows the distance that the front end of the pickup mechanism PU travels below the ground to be adjusted. A cutting device is provided at the front end of the pickup mechanism PU to sever the tomato vines V at or near the ground level. The cuffing device may be of various types, and a rotating cutting bar 26 is illustrated in FIG. 1 . The cutting bar 26 is rotatably attached at both ends to the header frame 18 and is rotated by a hydraulic motor (not shown). As the harvester H is driven forward, the cutting bar 26 encounters the individual vines V and severs them near the ground. After severing, the vines V fall onto the header conveyor 17 and are elevated for further processing on the main frame of the harvester H, as will be described hereinafter. Referring to FIG. 2 the overall operation of the tomato harvester H will now be described in general terms. A longitudinal transfer conveyor 28 is adapted to receive the tomatoes T and vines V from the header conveyor 17 . There is a small gap between the discharge end of the header conveyor 17 and the receiving end of the transfer conveyor 28 which allows loose tomatoes, dirt clods and other debris to drop from the vines V in transit. These loose tomatoes and debris fall onto one of two dirt cross conveyors 29 , 30 which transfer them to the right side and the left side respectively, of the harvester H (FIG. 2 ). It should be noted that the further processing undergone on both sides of the harvester H is identical and that such processing will be described only for the left side of the harvester H which is fed by the left dirt cross conveyor 30 . The loose tomatoes, dirt and other debris are discharged from the left dirt cross conveyor 30 through a dirt sorter electronic system 32 , where the red tomatoes are retrieved back onto a longitudinal sorter conveyor 27 . The dirt, debris, and green tomatoes fall off the conveyor through the dirt sorter electronic system 32 to a trash chute and then to the ground. Sorters, who stand on platform P, manually remove undesirable tomatoes and dirt that may have reached sorter conveyor 27 . The transfer conveyor 28 discharges vines V with attached tomatoes T to a set of feeder bars 31 . The feeder bars 31 direct the vines V under a shaker brush assembly 15 , which comprises a shaker brush 16 with shaker brush 16 , tines 19 , and a device for vibrating the shaker brush 16 , such as an eccentric weight assembly 14 . When vibrating the shaker brush 16 with an eccentric weight assembly 14 , bearing friction in the drive mechanism or a driven shaker brush, also results in the rotation of the shaker brush 16 . In the specification and claims a shaker brush is defined as a tined brush that provides rotational oscillation. Gravity and bearing friction from the eccentric weight assembly 14 or the driven shaker brush draw the vines V from the feeder bars 31 to a shaker conveyor 37 which moves the vines V in a rearward direction under the shaker brush 16 . The shaker brush 16 is positioned to engage the vines V supported on the shaker conveyor 37 . FIG. 3 illustrates a cut away side view of the feeder bars 31 , the shaker brush 16 , the shaker conveyor 37 and the moving roller 33 . Some of the tomatoes T which have been disengaged by the shaker brush 16 fall through the openings in the shaker conveyor 37 onto either of two food cross conveyors 34 . Other tomatoes T which have been disengaged by the shaker brush 16 are caught between vines V, and at first are not able to reach the openings in the shaker conveyor 37 . The shaker brush assembly 15 is disclosed in U.S. Pat. No. 5,860,859, incorporated by reference. The shaker conveyor 37 causes the vines V with loosened tomatoes T to pass below a vine reel 39 . The vine reel 39 separates the vines V from the tomatoes T, and allows tomatoes T to fall from the vines V and through the shaker conveyor 37 to a food conveyor 35 , located beneath the shaker conveyor 37 . The vine reel 39 is disclosed in U.S. Pat. No. 5,197,269, incorporated by reference. As shown in FIG. 3, the remaining vines V and tomatoes T are conveyed by the shaker conveyor 37 to the rear of the harvester H, where they are allowed to fall onto a recovery shaker conveyor 97 . As the vines V fall onto the recovery shaker conveyor 97 , the vines V rotate 180° and impact onto the recovery shaker conveyor 97 . During rotation and upon impact, some of the tomatoes T are further disengaged from the vines V. Some of the tomatoes T which have been further disengaged by the rotation and the impact fall through the openings in the recovery shaker conveyor 97 onto a recovery cross conveyor 95 . The recovery shaker conveyor 97 comprises a first endless belt and a second endless belt with a plurality of metal rods 49 extending in parallel there between. The first and second endless belts extend under the shaker conveyor. The plurality of rods 49 , extending across the recovery shaker conveyor 97 , are spaced apart to allow tomatoes T to pass between the rods 49 to the recovery cross conveyor 95 below the recovery shaker conveyor 97 . In the preferred embodiment, the plurality of rods 49 are spaced a distance “d 1 ” of 4 inches apart. Preferably, the rods 49 are spaced in the range of 3 inches to 6 inches apart. FIG. 4 illustrates the section taken along lines 4 — 4 of FIG. 3, illustrating the vine reel 39 and the shaker conveyor 37 . The vine reel 39 is mounted on a shaft 51 , upon which the vine reel 39 rotates. The shaft 51 is mounted on a frame member 53 . A reel drive 52 , which surrounds a significant length of the shaft 51 , is attached to the shaft 51 and driven by the shaft 51 . The shaft 51 is driven by a shaft pulley 57 , which is driven by a drive belt 59 , which is driven by a drive pulley, which is driven by a motor. Spiders 61 are connected to the reel drive 52 and are rotated by the reel drive 52 . The shaft 51 and the reel drive 52 pass through the centers of the spiders 61 . At the end of each arm 67 of the spiders 61 are bats 69 , which extend from an arm 67 of one spider 61 to the arm 67 of another spider 61 . The bats 69 are journaled to rotate with respect to the arms 67 . At the ends of each bat 69 are flanges 71 with the first end of a flange 71 connected to a bat 69 . The second end of each flange 71 is connected to a ring 73 by a pin 74 . The ring 73 is mounted on three rollers 75 . The rollers 75 are mounted on a reel cam 77 . The center 81 between the rollers 75 is offset from the center 65 of the shaft 51 so that the center 65 of the shaft 51 passes through the triangular area 79 at a set distance from the center 81 of the three rollers 75 . In this configuration, center 65 of the shaft 51 rotates around center 81 of the three rollers 75 . A plurality of tines 91 extend downward from the bats 69 . In operation, the shaker conveyor 37 passes vines V and loosened tomatoes T, which are caught among the vines V, under the vine reel 39 . The shaker conveyor 37 rotates in a clockwise direction as indicated in FIG. 3, to carry the vines V from under the shaker brush 16 . The vine reel 39 is rotated in a counter clockwise direction as indicated so that near the shaker conveyor 37 the tines 91 move in the same direction as the shaker conveyor 37 . As viewed in FIG. 3, the tines 91 on the left side of the vine reel 39 enter the vines V in a substantially vertical downward direction with a substantially zero velocity along the direction of movement of the shaker conveyor 37 . The tines 91 on the bottom of the vine reel 39 pass over the shaker conveyor 37 with a velocity along the direction of movement of the shaker conveyor 37 , which is substantially twice the velocity of the shaker conveyor, and with a vertical velocity of substantially zero. As viewed in FIG. 3, the tines 91 on the right side of the vine reel 39 leave the vines V in a substantially vertically upward direction with a substantially zero velocity along the direction of movement of the shaker conveyor 37 . Therefore, as the tines 91 move from left to right under the vine reel 39 , as viewed in FIG. 3, the tines 91 go from a substantially zero velocity along the direction of the shaker conveyor 37 , to twice the velocity of the shaker conveyor 37 along the direction of the shaker conveyor 37 , to a substantially zero velocity along the direction of the shaker conveyor 37 . The change in velocity of the tines 91 with respect to the movement of the shaker conveyor 37 , causes the vines V which engage the tines 91 to be agitated and separated allowing loosened tomatoes T, which are caught between the vines V, to escape from between the vines V and pass through the shaker conveyor 37 to the food conveyor 35 . By keeping the tines 91 substantially vertical, the tines 91 can be easily inserted into and removed from the vines V, and are useful in separating the vines V. The food conveyor 35 carries the tomatoes T forward on the harvester H and discharges them onto either of the two food cross conveyors 34 , with only the left food cross conveyor 34 being shown in FIG. 2 . The tomatoes T which have fallen onto fruit cross conveyor 34 are discharged onto the sorter conveyor 27 where the tomatoes T join the other tomatoes T directed there by the left dirt cross conveyor 30 . The tomatoes which have fallen onto the other food cross conveyor 34 are discharged to the other side of the harvester H where they join the second processing line. The tomatoes T discharged from the sorter conveyor 27 , having been manually and mechanically sorted to remove undesirable tomatoes and debris, are directed to an automatic color sorter 40 where further undesirable tomatoes may be ejected from the harvester H. A suction fan and suction fan housing 38 are provided to further remove debris before the debris reaches the color sorter 40 . Undesirable tomatoes which are ejected from the harvester H by the color sorter 40 , are directed onto the recovery cross conveyor 95 where they can be further inspected. The inspected tomatoes are then discharged onto the cross feed conveyor 41 where they join the inspected tomatoes from the other side of the harvester H, all tomatoes T then being directed to the right hand side of the harvester H. From the cross feed conveyor 41 , the tomatoes T are directed to the discharge conveyor 42 where the tomatoes T are elevated and discharged into a receiving truck TR (FIG. 1) which travels alongside the harvester H. In another preferred embodiment of this invention, the undesirable tomatoes and debris pulled from an after sort conveyor 64 , are placed onto a recovery sorter conveyor 99 which runs underneath the after sort conveyor 64 . This recovery sorter conveyor 99 directs the undesirable tomatoes and debris onto the recovery cross conveyor 95 , where they can be further inspected. The shaker conveyor 37 comprises a first endless belt 45 and a second endless belt 47 with a plurality of metal rods 49 extending in parallel there between. The plurality of rods 49 , extending from the first endless belt 45 to the second endless belt 47 , are spaced apart to allow tomatoes T to pass between the rods 49 to the food conveyor 35 below the shaker conveyor 37 . Preferably, the rods 49 are spaced at a distance “d 1 ” in the range of 3 inches to 6 inches apart. In the most preferred embodiment, the plurality of rods 49 are spaced a distance “d 1 ” of 4 inches apart. The food conveyor 35 also comprises first and second endless belts 83 with a plurality of metal rods 84 extending in parallel there between. Preferably, the rods 84 are spaced at a distance “d 2 ” of 0.5 inches to 2 inches apart. In the most preferred embodiment, the spacing between the metal rods 84 of the food conveyor 35 is a distance “d 2 ” of 1 inch apart. The shaker conveyor 37 extends almost to the dirt cross conveyors 29 , 30 , under the roller 33 , under the feeder bars 31 , under the shaker brush 16 , and under the vine reel 39 . The shaker conveyor 37 surrounds the food conveyor 35 and the food cross conveyors 34 , so that part of the shaker conveyor 37 is above the food conveyor 35 and the food cross conveyors 34 and part of the shaker conveyor 37 extends under the food conveyor 35 and the food cross conveyor 34 . Because the metal rods 49 extend across the shaker conveyor 37 , the shaker brush 16 is positioned sufficiently above the shaker conveyor 37 so that the tines 19 of the shaker brush 16 do not reach or pass through the shaker conveyor 37 . In operation, the transfer conveyor 28 discharges vines V with attached tomatoes T to a set of feeder bars 31 . The feeder bars 31 direct the vines V under a shaker brush 16 . Gravity and bearing friction pull the vines V from the feeder bars 31 to a shaker conveyor 37 which moves the vines V in a rearward direction under the shaker brush 16 . Falling from the feeder bars 31 to the shaker conveyor 37 allows the vines V to fall out of the shaker head assembly, allowing the volume 5 of the vine mass to expand. The expansion of the vine mass, provides a separation of the vines V, allowing loosened tomatoes to drop from the vine mass, through the shaker conveyor 37 to the food cross conveyor 34 . Although extending the conveyor so that vines V may drop out of the shaker brush 16 and moving the vines V through the shaker brush 16 by use of the shaker conveyor 37 improves the release of the tomatoes T from the vines V, some loosened tomatoes are still caught in the vine mass. For this reason, the shaker conveyor 37 causes the vines V with loosened tomatoes to pass below a vine reel 39 . The vine reel 39 separates the vines V and allows tomatoes T to fall through the vines V and through the shaker conveyor 37 to a food conveyor 35 . The tomatoes, dirt and other debris which have fallen onto the recovery cross conveyor 95 are discharged from the recovery cross conveyor 95 through a dirt sorter electronic system 32 , where the red tomatoes are retrieved back onto a longitudinal recovery feed conveyor 93 . The dirt, debris, and green tomatoes fall off the recovery cross conveyor 95 through the dirt sorter electronic system 32 to a trash chute and then to the ground. Red tomatoes which have been retrieved back onto the longitudinal recovery feed conveyor 93 are then discharged onto the cross feed conveyor 41 where they join the inspected tomatoes from the other side of the harvester H, all tomatoes T then being directed to the right hand side of the harvester H. From the cross feed conveyor 41 , the tomatoes T are directed to the discharge conveyor 42 where the tomatoes T are elevated and discharged into a receiving truck TR (FIG. 1) which travels alongside the harvester H. The invention is an improvement over the apparatus described in U.S. Pat. No. 5,860,859 incorporated by reference, in that this invention provides a recovery system which reduces food losses from the main recovery system, the handsorters, and the color sorters. The apparatus described in U.S. Pat. No. 5,860,859 causes a nominal amount of red tomatoes to fall to the ground as trash due to inaccurate sorting by the handsorters and the color sorters. Moreover, since not all the tomatoes T are shaken from the vine V by the shaker brush, many tomatoes T fail to get inspected since they remain entangled with the vines V. In this invention, a recovery shaker conveyor 97 is added beneath the shaker conveyor 37 to loosen more tomatoes T from the vine V. In addition, a recovery cross conveyor 95 is added beneath the recover shaker conveyor and the color sorter 40 in order to recover additional tomatoes T. This improved recovery system is able to recover a greater amount of desirable tomatoes T. While in the foregoing specification this invention has been described in relation to certain preferred embodiments thereof, and many details have been set forth for purpose of illustration, it will be apparent to those skilled in the art that the invention is susceptible to additional embodiments and that certain of the details described herein can be varied considerably without departing from the basic principles of the invention.

The invention provides a method and apparatus for recovering food losses from the main recovery system, the handsorters, and the color sorters. A recovery shaker conveyor located beneath the main recovery system to catch food and vines which are tossed off the end of the main recovery system. The food and vines are turned over during the fall, thus loosening some food from the vine. The loosened food falls through the openings in the recovery shaker conveyor onto a recovery cross conveyor which is situated in between the chains of the recovery shaker conveyor and under the handsorters. Food which is rejected by the color sorters also falls onto the recovery cross conveyor and is directed toward a dirt sorter electronic system. The food which is rejected by the handsorters, is placed on a recovery sorter conveyor which is fed into the recovery cross conveyor for re-examination. The dirt, debris, and unsuitable food fall off the recovery cross conveyor through the dirt sorter electronic system to a trash chute and then to the ground. The remaining suitable food is then guided along a recovery feed conveyor which drops the remaining suitable food onto the discharge conveyor, where the suitable food is elevated and discharged into a receiving truck.

CROSS-REFERENCE TO RELATED APPLICATION This is a divisional of Application Ser. No. 888,996 filed July 31, 1986 and now U.S. Pat. No. 4,783,524 issued Nov. 8, 1988, which was a continuation-in-part of application Ser. No. 777,117 filed Sept. 17, 1985, now abandoned. BACKGROUND OF THE INVENTION Insulin-like growth factors (IGF's) have been identified in various animal species as peptides that are biologically active in growth, e.g. via proliferation of cells. They are believed to mediate effects of somatotropins and possibly other hormones. The designation "insulin-like growth factor" was chosen to express the insulin-like structures and effects of these peptides. IGF's have nearly 50% homology with insulin. In three dimensional structure they resemble proinsulin, i.e., they are single-chain peptides cross-linked by three disulfide bridges and containing an A-chain portion (A domain), a B-chain amino-terminal portion (B domain) and an A-B connecting chain (C domain). A carboxy-terminal extension (D domain) not found in proinsulin is also present in at least some IGF's. Several classes of IGF's have been identified in animals. Normally these include IGF-I, IGF-II and others. Circulating levels of these peptides appear to be under the control of somatotropin to some extent, with IGF-I controlled to a greater extent than IGF-II. In various cell culture systems, IGF's have shown mitogenic effects measured, e.g., by increased tritiated thymidine incorporation. It has been demonstrated that in some animals, at least two sets of IGF receptors exist, one preferentially binding IGF-I and the second IGF-II, suggesting separate functions for IGF-1 and IGF-II. However, the biological functions of IGF-II appear to vary among mammalian species. For example, while rat IGF-II levels have been found 20-100 fold higher in fetal than maternal circulation, human serum IGF-II in the fetus is normally lower than in adults. Because of its potential bioactivity and utility for enhancing desirable cell growth in animals, the amino acid sequence of bovine IGF-II ("bIGF-II") has long been sought together with a more detailed understanding of its growth-promoting and other activities, its active fragments, etc. Heretofore, neither that sequence nor the DNA sequence of the bIGF-II gene has been reported. Studies with rat and human genomic libraries suggest that IGF-II genes contain at least four exons. The large size and complexity of the genes for human and rat IGF-II have made their isolation and identification so difficult that the DNA sequences of those genes have not yet been fully determined. For purposes of making and studying bIGF-II, however, there has been a need to isolate and determine the complete DNA sequence of the bIGF-II gene. Accordingly, it is an object of this invention to provide highly purified and/or synthetic peptides having one or more of the biological activities of bIGF-II and, more generally, such peptides consisting essentially of amino acids providing such activity, or peptides which can be readily converted to those having such activity. It is another object of this invention to provide methods using such peptides to promote desirable growth or functionality of cells in animals including, e.g., muscle and/or mammary epithelial cells. Another object of this invention is to provide DNA useful in making such peptides. Another object of this invention is to provide processes utilizing such DNA in the production of such peptides. Other objects will be apparent from the detailed description herein and the appended claims. SUMMARY OF THE INVENTION This invention is based largely on the herein-reported original discoveries of the amino acid sequences of bIGF-II and various precursors thereof, and the nucleotide sequences of DNA coding for bIGF-II and such precursors, all as shown hereinbelow. In one embodiment, the invention provides certain novel peptides consisting essentially of the following sequence of amino acids (reading from the amino end to the carboxy end of said sequence) which correspond to the heretofore-undetermined amino acid sequence of bIGF-II: ______________________________________Ala--Tyr--Arg--Pro--Ser--Glu--Thr--Leu--Cys--Gly--Gly--Glu--Leu--Val--Asp--Thr--Leu--Gln--Phe--Val--Cys--Gly--Asp--Arg--Gly--Phe--Tyr--Phe--Ser--Arg--Pro--Ser--Ser--Arg--Ile--Asn--Arg--Arg--Ser--Arg--Gly--Ile--Val--Glu--Glu--Cys--Cys--Phe--Arg--Ser--Cys--Asp--Leu--Ala--Leu--Leu--Glu--Thr--Tyr--Cys--Ala--Thr--Pro--Ala--Lys--Ser--Glu.______________________________________ In other embodiments, the invention provides various methods for promoting growth and/or other desirable functions of cells in animals by administering peptides of this invention to animals in amounts sufficient to cause such effects. For example, animal muscle mass can be increased by suitably administering to the animal an amount of such peptide(s) effective to cause proliferation of satellite muscle cells in that animal. In another illustration, such peptide(s) can be suitably administered to female mammals in amounts effective to cause proliferation and/or galactopoietic stimulation of their mammary epithelial cells such that subsequent lactation is enhanced. In other embodiments, the invention provides certain novel nucleotide sequences (DNA) coding for such peptides. Typically, this DNA contains essentially the following sequence of nucleotides (or their functional equivalents for peptide expression): ##STR1## In other embodiments, the invention provides processes for producing such peptides by effecting expression of such DNA, recovering and then optionally further purifying the resulting peptides, e.g. to an essentially pure form. DETAILED DESCRIPTION OF THE INVENTION As used herein, the symbols representing amino acids (e.g. Ala for alanine) and nucleotides (C, A, G or T) are those conventionally employed. See Lehninger (1976). The Peptides As used herein, the term "synthetic peptide" means a peptide produced by a technique (e.g. chemical synthesis or recombinant DNA expression) other than its natural production in a living animal. Accordingly, the "synthetic" peptides of this invention are to be distinguished from peptides produced in living animals via expression of DNA occurring naturally in those animals. As produced, such "synthetic" peptides are normally free from peptides of bovine (and usually other animal) origin. In other embodiments, however, peptides of this invention can be prepared by isolation from peptide mixtures produced in living animals, e.g. as in Example 1. Using any mode of preparation in which a peptide of this invention is isolated from other peptide(s) of bovine or other animal origin, the isolation is typically carried out to provide a peptide of this invention essentially free from such other peptide(s), i.e., mixed with little enough of such other peptide(s) that the latter do not interfere substantially with the desired bioactivity of the peptide of this invention. As used herein, references to peptides "consisting essentially" of the sequence of bIGF-II (alone or extended at either or both of its amino and carboxy termini) should be understood as referring to peptides comprising the recited sequence or only as much of that sequence as is needed to provide one or more of the biological activities of bIGF-II in substantial measure (typically at least about 0.1%, preferably at least about 1% and even more desirably at least about 10% of that activity of pure intact bIGF-II). Those biological activities of bIGF-II include, but are not limited to, insulin-like activity and the ability (alone or with other biologically active substances) to stimulate animal cell proliferation or lactation by already-formed mammary epithelial cells. Amino acids that are essentially superfluous with respect to such activity can be omitted, resulting in peptides of fewer amino acids than are contained in the recited peptide itself. Also embraced by such references are peptides which have such activity despite the presence therein of one or more amino acids substituted for any of those in the amino acid sequences (shown herein) of bIGF-II or its naturally-occurring precursors. For example, peptides in which a methionine is substituted for the amino-terminal alanine in the bIGF-II sequence shown above is expected to have bIGF-II-like activity and to be readily producible via recombinant DNA (rDNA) in bacteria or other microorganisms that do not remove such an N-terminal methionine residue. Also embraced by such references are various larger peptides containing the recited sequence (or such a deletion and/or substitution variant thereof) together with one or more additional amino acids directly attached to its amino and/or carboxy terminus, as well as such peptides otherwise modified at their termini or elsewhere, e.g. by glycosylation, phosphorylation, amidation or the like, to the extent such peptides can be used (with or without further processing) to provide a biological activity of bIGF-II in substantial measure. In one approach employed in identifying the bIGF-II amino acid sequence disclosed herein, bIGF-II was isolated and purified from bovine serum. Although the liver is the major source of IGF production in most animals, and IGF's have been detected in many body tissues such as muscle, cartilage, brain and cerebral spinal fluid, serum is the preferred source of IGF's generally, and IGF-II specifically. Methods for separation and isolation of IGF's have been described in the art, e.g. by Svoboda et al., Van Wyk et al., Liberti, Bala et al. and Zumstein et al. The active bIGF-II isolated and purified from bovine serum in accordance with the present invention was found to be a single peptide having a molecular weight of about 7400 daltons and the sequence of 67 amino acids shown above. A preliminary screen for biological activity associated with the purified bIGF-II and quantitation thereof was performed by a rat placenta radioreceptor assay described in Daughaday et al. The present discovery of the complete amino acid sequence of bIGF-II is significant as it provides a basis for production of peptides having bIGF-II activity. Such production can be carried out by any available process. For example, small (e.g. research) quantities can be produced using conventional peptide synthesizing equipment. On a larger scale, such production can be carried out by chemical synthesis or, usually more satisfactorily, in microbial hosts or cell cultures utilizing rDNA coding for peptides of this invention. Using such DNA in conjunction with techniques of genetic engineering, there can be manufactured much larger quantities of such peptides than could ever be practically recovered from bovine serum or tissues. As described more fully below, the amino acid sequence of bIGF-II has now been confirmed by isolating and characterizing bIGF-II gene fragments from bovine kidney genomic DNA. Even before such gene characterization, however, synthetic peptides of this invention simulating bIGF-II structurally could be produced following the herein-reported discovery of the bIGF-II amino acid sequence, e.g. by known techniques using rDNA made to code for that amino acid sequence. Thus, when such peptides are to be produced using rDNA in microbial hosts such as bacteria or yeast, a DNA sequence coding for that amino acid sequence and optionally composed of bIGF-II codons preferred by the selected host (see U.S. Pat. No. 4,356,270 issued Oct. 26, 1982 to K. Itakura) can be designed and produced synthetically. Production of peptides of this invention by rDNA and/or chemical synthesis may result in minor alterations in amino acid composition. For example, production in bacteria may result in addition of a methionine at the amino (N-) terminus, chemical synthesis may result in variations of the carboxy (C--) terminus such that any of the radicals --COOR:, --CR 1 O, --CONHNR , --CONR 1 R 2 or --CH 2 OR (R 1 and R 2 being independently lower alkyl or hydrogen) may be found. These peptides are among those of the present invention insofar as their bIGF-II-like biological activity is not diminished to an intolerable degree. In some instances, peptides of this invention will be isolated or prepared in a denatured, biologically inactive condition. In its normal, biologically-active (undenatured) state, bIGF-II is cross-linked by three disulfide bridges. By analogy to human IGF-II and IGF-1, these bridges are believed to exist between amino acid (cysteine) positions 9 and 47, 21 and 60, and 46 and 51 (see Yamashiro et al.), but the scope of this invention is not to be limited thereto. Peptides of this invention that lack such desired bridging can be activated by peptide naturation techniques well known in the art, usually by subjecting the peptide to conditions (pH, temperature, oxidizing environment, etc.) under which it assumes its biologically active, three-dimensional configuration and forms the disulfide bonds (bridges) similar to those in biologically active bIGF-II. The particular technique employed is not critical for purposes of this invention so long as biological activity is conferred to the extent desired. The amino acid sequence differences between human, rat and bovine IGF-II's occur mainly in the regions generally characterized as their C domains. bIGF-II analyzed for purposes of the present invention was consistently found to have an N-terminal alanine as shown in TABLE II. This was consistent with the N-terminal alanine reported for human and rat bIGF-II's by Humbel but at variance with the N-terminal tyrosine (des Ala) reported for human IGF-II in Rinderknecht et al. and rat IGF-II in Marquardt et al. Such bIGF-II's having an N-terminal tyrosine may exist as a result of allelic and/or processing variations not detectable from the bovine serum used herein, or as a consequence of unintended deletion of the N-terminal alanine during purification. In any event, such N-tyrosine variants are to be considered equivalents of the peptides of this invention to the extent they have bIGF-11 biological activity. With the herein-reported amino acid sequence and biological activities of bIGF-II, it is now possible to identify allelic forms of bIGF-II and/or make bIGF-II variants having biological activities equal or superior to those of bIGF-II. Hence it is anticipated that the isolation of allelic forms of bIGF-II and production of such variants having amino acid deletion(s), substitution(s) and/or addition(s) with respect to bIGF-11 will provide various useful embodiments of the peptides disclosed herein. Identifying such alternative peptides is within the ability of those skilled in the art. From DNA sequencing described below, and by analogy to human IGF-II ("hIGF-II"), it is believed that bIGF-II is first synthesized intracellularly as a precursor peptide having a signal (leader) sequence of at least 24 amino acids immediately preceding the N-terminus of the mature bIGF-II and that, on secretion of the precursor peptide from bIGF-II-producing cells, that signal sequence is cleaved. The peptides of this invention containing such a signal sequence (or any desired portion thereof) can be produced by expression of such DNA (first deleting the codon(s) for any amino acid(s) not wanted in that sequence) and are useful for production of peptides of this invention corresponding in amino acid sequence to mature bIGF-II, e.g. via chemical, microbial or enzymatic removal of that signal sequence. From other novel DNA sequences disclosed herein, it is believed that there is a bIGF-II precursor peptide having a carboxy-terminus extension containing about 89 amino acids. The novel sequence of the first 68 amino acids of that extension (beginning at the carboxy terminus of bIGF-11) is disclosed herein. By analogy to proinsulin, it is believed that peptides of this invention containing such a carboxy extension provide the biological activity of bIGF-II in substantial measure and accordingly, these extended peptides are within the scope of the present invention. Uses of the Peptides As described more fully below, the isolation and characterization of bIGF-II in accordance with the present invention has provided an opportunity to more clearly identify and define aspects of the bioactivity of bIGF-II. For example, it has been found that bIGF-II is active in the rat L6 myoblast cell proliferation assay and is able to stimulate proliferation of bovine mammary epithelial cells and lactation by such mammary cells in vitro. Accordingly, it is considered that the peptides of this invention have activity for in vivo proliferation of various bovine cells, e.g. mammary epithelial and satellite muscle cells, and for in vivo stimulation of already-formed mammary epithelial cells to increase their rate of milk production. It is further considered that peptides of the present invention are effective for similarly increasing the muscle content and/or lean-to-fat ratio in animal species other than cattle (e.g. sheep, goats, swine, chickens, turkeys, ducks and other fowl) and for increasing lactation in mammals other than cattle (e.g. sheep, goats and swine) when sufficient homology exists between bIGF-II and the IGF-II's of such animal species. In adult animals, the myofiber (e.g. muscle cell) number is fixed so that increased muscling results only from muscle cell hypertrophy and proliferation of satellite muscle cells. Myofibers are formed in utero by the fusion of replicated embryonic muscle cells. Replicating muscle cells which persist in the adult are called satellite muscle cells. Satellite muscle cells may be stimulated to replicate and thereafter fuse with existing myofibers to yield increased myofiber nuclei. This increase in myofiber nuclei is expected to manifest itself as increased muscle content (mass). The L6 myoblast proliferation assay provides a reliable in vitro indicator of IGF activity and is used as a model for factors affecting embryonic myoblasts and adult satellite cells. Factors active in this system behave similarly in primary cultures of bovine myoblasts. See Gospodarowicz et al. The enhancement of rat L6 myoblast proliferation in vitro by a peptide of this invention indicates its activity in causing increased myoblast proliferation and, therefore, an increase in ultimate myofiber number in utero. In addition, similar enhancement of rat L6 myoblast proliferation indicates that peptides of this invention can be used to enhance adult muscle hypertrophy, e.g. via stimulation of satellite muscle cell proliferation. In lactating animals, the amount of mammary epithelial tissue is a limiting factor in milk production, as these are the cells which produce and secrete milk. Employing in vitro systems, it has been demonstrated that epithelial cells obtained from mammary glands of animals can be stimulated by bIGF-II to proliferate to produce increased quantities of milk constituents. It has further been demonstrated that mammary epithelial cells stimulated to proliferate in one such in vitro cell system can be reimplanted in cleared mammary fat pads (see Yang and Nandi) where they can be stimulated to proliferate and/or produce milk. These discoveries indicate that peptides of this invention are biologically active in vivo for increasing bovine lactation, e.g. by any suitable administration to pregnant cows or heifers. One such technique is described in copending U.S. Pat. application Ser. No. 837,477 filed Mar. 7, 1986, the disclosure of which is incorporated herein by reference. Thus, the peptides of this invention are useful for administration to animals, especially (but not only) nonhuman animals, for increasing milk production and/or the lean-to-fat ratio or muscle content in animals. For purposes of such uses, one or more peptides of this invention (or non-toxic salts thereof) can be combined with a non-toxic, physiologically acceptable carrier (liquid or solid) to form a composition which can be administered to animals by any suitable technique, e.g. intravenously, subcutaneously, intramuscularly, intranasally, or orally in a form that protects the peptide from degradation in the digestive tract. Such compositions can be administered to the animal by injection, infusion or implantation, preferably in a medium (e.g. dispersion in oil or a polymer) which facilitates delivery of the peptide to target cells of the animal at a desired rate. The proportions of carrier and biologically active peptide in such compositions can be any that facilitate the desired effects in animals. Preferred proportions can be readily determined by those skilled in the art. The required dosage will vary with the particular result sought and duration of desired treatment. The amount or dosage most effective for achieving a desired result (e.g. increased milk production) can be determined by routine experimentation. The preferred dosage may depend on such variables as the size, general health and nutritional status of the specific animal. Bioactive peptides of this invention can be used in an essentially pure form, i.e., free from other peptides (of whatever origin) having a significant effect on the bioactivity of the peptide(s) of this invention. This is not essential, however, as in many utilities peptides of this invention can be used satisfactorily (in many cases, even advantageously) in mixtures or other combinations with different peptides, e.g. other animal growth factors such as bovine (or other animal) IGF-I, EGF or TGF-α (alpha-transforming growth factor). The DNA As used herein with reference to such DNA, the term "synthetic" means it has been made by any technique other than its natural replication in a living animal. Utilizing the nucleotide sequences described herein, any DNA of this invention can be prepared by various techniques well known in the art, e.g. automated DNA synthesizing equipment, other chemical synthesis procedures, cDNA or cloning in a microorganism. Any ,suitable technique can be used. As used herein, the term "containing a] sequence of nucleotides" means that the recited nucleotides are present in such DNA without intervening non-translated nucleotides (e.g. introns). Since the naturally-occurring DNA for bIGF-II contains such intervening untranslated nucleotides, the DNA of this invention containing nucleotide sequences lacking any of such untranslated nucleotides are ipso facto "synthetic." The term "essentially pure", when used herein to describe nucleic acid (DNA or RNA) sequences or molecules, means substantially free from nucleic acid sequences with which the described sequence or molecule is normally associated in its natural state. For purposes of this invention, DNA fragments coding for the mature bIGF-II peptide, a precursor including a leader sequence containing 24 amino acids, and 68 of 89 amino acids of a carboxy extension (E domain) have been isolated and sequenced. As described in Example 4, essentially pure DNA fragments coding for these peptides were isolated from bovine kidney genomic DNA. Analysis of these fragments revealed the following DNA sequence and corresponding amino acid sequence for a bIGF-II precursor protein: ##STR2## The foregoing underlined DNA sequence and corresponding amino acid sequence are those of mature bIGF-II as identified for purposes of the present invention. As shown in the above bIGF-II precursor peptide sequence, three possible translation start-signal codons (ATG's) are in-frame with the DNA sequence coding for mature bIGF-II. It is believed that the first of those ATG's constitutes the operable start of translation for the bIGF-II precursor, but certain host cells may recognize one of the alternative in-frame translation start-signal codons, thereby giving rise to a bIGF-II precursor having an alternative (shorter) leader sequence. If desired, such shortened precursor peptides can be produced by other means, e.g. by using synthetic DNA of this invention beginning with one of the alternative ATG translation start-signal codons. Further, the gene fragments isolated and sequenced in the present invention revealed an E domain (carboxy-terminal extension) for another precursor of the mature bIGF-II peptide. This extension and the DNA coding for it were found to have the following sequences: ##STR3## The discovery and isolation of the DNA sequence for bIGF-II are significant as they not only verified the amino acid sequence determined for purified bIGF-II but provided the DNA sequences and corresponding amino acid sequences for the bIGF-II leader peptide, and carboxy-terminal peptide extension (E domain). Further, the novel DNA sequences of this invention enable those skilled in the art to identify, isolate and/or provide other bIGF-II precursor proteins and/or biologically active fragments thereof including, but not limited to, other peptides having bIGF-II-like activity. The biological activities of these peptides, fragments thereof and products containing same can include, but are not limited to, the growth- and/or lactation-promoting activities of bIGF-II described herein, and can be ascertained in accordance with herein-described or other in vitro and/or in vivo assays. These biologically active fragments and products are herein referred to as "IGF-II gene-related proteins" and include peptides at least a portion of which is encoded in DNA of this invention, allelic variations thereof and/or DNA that hybridizes to DNA of this invention. Having been derived using DNA of this invention or such variations, those IGF-II gene-related proteins are within the scope of this invention. The DNA sequences and genes of the present invention now enable those skilled in the art to more effectively study and/or control IGF-II biosynthesis and biological regulations. Additionally, DNA sequences of this invention can be employed by those skilled in the art to identify and isolate other IGF DNA sequences, IGF genes and IGF gene-related peptides in other species such as, but not limited to, ovine, caprine porcine and avian IGF's, wherein sufficient DNA sequence and/or peptide homology exists. The discovery of the aforementioned leader (signal) sequence enables construction of DNA vectors for production of bIGF-II-like peptides in eucaryotic cells (e.g. mammalian cells and yeast) capable of recognizing and removing the signal sequence, or bIGF-II precursor peptides containing the signal peptide and/or E domain in procaryotic hosts such as bacteria. A preferred method for producing the synthetic peptides of the present invention is by rDNA technology utilizing host cells such as bacteria (e.g. E. coli) or eucaryotic cells such as yeast. Modifications of these DNA sequences herein can be made to affect their efficiency of peptide production in a desired host cell. Such modifications include, but are not limited to, host-preferred codon substitution, construction of DNA coding for fusion proteins including a peptide of this invention, substitution of codons to eliminate or enhance mRNA structural features affecting their translation, and other modifications that improve production of such peptides in the selected host cell. The peptides so produced which exhibit biological activity of the purified bIGF-II described herein in substantial measure are to be considered equivalents of the peptides of this invention. The following examples illustrate specific embodiments of the invention. They are not to be taken as limiting the invention's scope in any way. Various modifications will be apparent to those skilled in the art, with or without the other disclosure herein. All temperatures are in degrees Celsius unless otherwise stated. EXAMPLE I As described in this example, the complete amino acid (AA) composition and sequence of bIGF-II were determined from that peptide isolated and purified from adult bovine serum obtained from Sigma Chemical Co. (St. Louis, Mo.). Partially purified fractions of such bIGF-II were obtained using a combination of isolation procedures described by Svoboda et al. and Zumstein et al. The complete purification of bIGF-II essentially free from other bovine peptides was achieved by reverse phase high performance liquid chromatography (HPLC). All HPLC procedures were accomplished using trifluoroacetic acid (TFA) and acetonitrile. The solvents were delivered to the column at 2 ml/min using a Perkin-Elmer (Norwalk, Conn.) Series 4 HPLC pumping system, and the peptide was visualized using a Hewlett Packard (Greenly, Conn.) 1040A UV/VIS detector. All chromatographic procedures were carried out at ambient room temperatures (23°-28°). The bIGF-II used for the initial sequence determination was prepared using a Chromega fluorodecyl 4.1×250 mm column (E.S. Industries, Marlton, N.J.). Elution of bIGF-II from the Chromega column was accomplished using a linear gradient of acetonitrile from 15-50% (v/v) over 35 min with the TFA concentration maintained at 40 mM. The bIGF-II samples used for complete structural verification were prepared using a Nucleosil C-18 4.1×250 mm column (Altech Associated, Deerfield, Ill.). The solvent system employed for separation on the column was a linear acetonitrile gradient from 30-35% (v/v) over 15 minutes with a constant TFA concentration of 20 mM. Identification of the active bIGF-II was made using the rat placenta radioreceptor assay described in Daughaday et al. This assay also provided an estimate of the quantity of bIGF-II in the final samples. The HPLC-purified bIGF-II was subjected to AA sequence analysis using an Applied Biosystems, Inc. (Foster City, Calif.) Protein Sequencer Model 470A according to the methods described by Hunkapiller et al. (1983a and b). Briefly, 2.5 nanomoles of the HPLC-purified bIGF-II were lyophilized and analyzed on that Sequencer employing an Edman degradation reaction consisting of derivatizing the N-terminal AA with a reagent followed by cleavage of that AA and ultimate release as its phenylthiohydantoin (PTH) derivative. Since N-terminal sequence analysis was unable to provide the complete structure for the peptide, the purified IGF-II was derivatized and enzymatically hydrolyzed using the following procedure: After purification, 75 mg bIGF-II was subjected to performic acid oxidation using the procedure of Hirs for denaturation by converting sulfhydryls to cysteic acid residues. The peptide was dissolved in 50 ml 88% formic acid (Fisher Scientific, Springfield, N.J.) and the solution cooled to 0°. After one hour at room temperature, 5 ml of the performic acid reagent (0.5 ml 30% H 2 O 2 (Fisher Scientific) in 9.5 ml 88% formic acid) was added to the peptide solution. The resulting mixture was allowed to stand at 10° while progress of the reaction was followed using the second reverse phase HPLC procedure specified. On completion (after 45 min), 4 ml water was added to the mixture and the reagents were removed in vacuo using a Speed Vac Concentrator (Savant Instruments, Farmingdale, N.Y.). The residue remaining after solvent removal was dissolved in 1 M NaHCO 3 containing 1 mM CaCl 2 (both Fisher Scientific). The enzymatic hydrolysis was initiated by adding 2 ml of a 0.1 M HCl/2 mM CaCl 2 solution containing 8 mg/ml alpha-chymotrypsin (Sigma Chemical Co.) (16 mg protein added). After 45 min at room temperature, the chymotrypsin was removed using a Centricon-10 (Amicon Corp., Danvers, MA) ultrafiltration device. The filtrate (O-IGF-II chymotryptic hydrolysate) was subjected to reverse phase chromatography using the Nucleosil column and the 20 mM TFA/acetonitrile solvent previously specified. Eluting the column with a linear gradient of acetonitrile from 10 to 70 % (v/v) over 30 min resolved the hydrolysate into 10 major peptide-containing peaks. Sequence analysis of the peptides (performed as above on Model 470A Sequencer in conjunction with an Applied Biosystems Inc. Model 120A PTH Analyzer) from 3 isolated peaks showed that 2 of them contained the AA's required to complete the primary structure elucidation for bIGF-II. TABLE II shows the N-terminal sequence analysis of the peak HPLC material together with the published sequences for human and rat IGF-II's. Residues 1-43 of the bIGF-II were determined by N-terminal sequence analysis of the purified bIGF-II. Residues 37-59 and 60-67 were determined by N-terminal sequence analysis of the two separate chymotryptic fragments. Molar cysteic acid content of the peptides was verified using precolumn orthophthalaldehyde AA analysis as described in Larsen et al. As shown in TABLE II, three differences were found between the bovine and human sequences and three differences were found between the bovine and rat sequences. TABLE II__________________________________________________________________________IGF-II Amino Acid Sequences__________________________________________________________________________ ##STR4##HumanNH.sub.2AlaTyrArgProSerGluThrLeuCysGlyGlyGluLeuValAspThrLeuGlnPheRatNH.sub.2AlaTyrArgProSerGluThrLeuCysGlyGlyGluLeuValAspThrLeuGlnPhe ##STR5##HumanValCysGlyAspArgGlyPheTyrPheSerArgProAlaSerArgValSerArgArgRatValCysSerAspArgGlyPheTyrPheSerArgProSerGly/Ser ArgAlaAsnArgArg ##STR6##HumanSerArgGlyIleValGluGluCysCysPheArgSerCysAspLeuAlaLeuLeuGluThrRatSerArgGlyIleValGluGluCysCysPheArgSerCysAspLeuAlaLeuLeuGluThr ##STR7##HumanTyrCysAlaThrProAlaLysSerGluCOOHRatTyrCysAlaThrProAlaLysSerGluCOOH__________________________________________________________________________ The bIGFII residues with an asterisk differ from the corresponding residues in human IGFII. The underlined bIGFII residues differ from the corresponding residues in rat IGFII. EXAMPLE II This example demonstrates the activity of bIGF-II in the rat L6 myoblast proliferation assay. Specifically, the peak HPLC material of Example I was compared to a commercial preparation of human IGF-I from Amgen Inc. (Thousand Oaks, Calif.) for demonstrable physiological activity in that assay. Rat L6 myoblasts described by Yaffee were used as described by Kotts. All incubations were carried out at 37° , 10% CO 2 , and 100% humidity. A Coulter Counter (Model ZM) equipped with a C-1000 Channelyzer (Coulter Electronics, Hialeah, FL) was used for cell counting. Stock cultures were maintained in Dulbecco's Minimum Essential Medium (DMEM) (Grand Island Biological Corp. (GIBCO), Grand Island, N.Y.) containing 10% (v/v) fetal calf serum (FCS medium) and routinely plated at 1200 cells/cm 2 or 600 cells/cm 2 and passaged after 3 or 4 days, respectively, in culture. Passaging was performed by adding 3 ml of 0.05% (w/v) trypsin (GIBCO) in wash buffer (0.8% (w/v) NaCl, 0.04% (w/v) KCl, 0.1% (w/v) dextrose, 0.058% (w/v) NaHCO 3 , 0.02% (w/v) EDTA, pH 7.4) for 5 minutes at 37° and trypsinization was stopped by adding 7 ml FCS media. Test cultures were prepared as follows: Stock cultures were trypsinized and pooled and the resulting cell suspension was counted. Based on this count, cells were diluted to the appropriate concentration in FCS media and rapidly plated in 25 cm 2 flasks at a density of 600/cm 2 . 24 hours after plating, the media was removed and cells were rinsed with serum-free DMEM. Test media (4 ml) was then applied to each flask and incubation was carried out for an additional 24 hours after which the culture medium was replaced with fresh test medium. Cultures were then incubated for another 48 hours and counted. For counting, the test media was removed, cells were rinsed with 2 ml of wash buffer, 1 ml of trypsin solution was added and the cells were incubated for 5 minutes at 37°. The reaction was stopped by addition of 3 ml of cold FCS media. Flasks were pounded 10 times to facilitate cell removal and tipped upright in an ice bath until their contents could be transferred to glass tubes on ice. Each flask was rinsed with 2-3 ml of cold 0.9% (w/v) NaCl and the rinse was added to the cell suspension. Each tube was vortexed gently 5 times to eliminate clumping of cells and the contents of each tube were counted using a Coulter Counter. Test media for application to the test cultures was prepared by diluting the test sample to the desired concentration with 2% (v/v) FCS medium. The lyophilized peak HPLC material of Example I was dissolved in 30 mM Tris-HCl, pH 7.4 (Tris buffer) to an estimated concentration of 2.6 μM. In Test 1, 0.2 ml of this solution was added to 19.8 ml 2% FCS (26 nM final conc.), filter-sterilized through a 0.22μ filter (Millipore Corp., Bedford, Mass.) and applied to the experimental cultures. A control containing 0.2 ml of the Tris buffer was included for comparison. In Test 2, 0.2 ml of the solution of HPLC material was added to 9.8 ml of 2% (v/v) FCS (estimated 52 nM final conc.), filtered as above, and applied to the experimental cultures. A control containing Tris buffer was prepared similarly. The positive control for each treatment was 10 -9 M human IGF-I (Amgen Biologicals, Thousand Oaks, Calif.). See Kotts et al. The lyophilized IGF-I was diluted with 44 mM NaHCO 3 , pH 7.4 to a concentration of 100 pg/ml. A 10 -8 M stock solution was prepared by adding 0.015 ml IGF-1 to 20 ml of 2% (v/v) FCS medium. For 10 -9 M, 2 ml of this stock was added to 18 ml of 2% FCS medium, filter-sterilized and applied to experimental cultures. The control for these cultures was 2% (v/v) FCS medium. In Test 3, peak HPLC material from Example I was dissolved in 20% acetic acid to an estimated concentration of 165 μM. Two stock media solutions were prepared. A 0.5 μM stock was prepared by adding 0.091 ml of 165 μM solution to 30 ml 2% FCS. pH was adjusted to 7.4 by adding 60 μl of 10% NaOH. A 0.1 μM stock was prepared by adding 0.018 ml of 165 μM solution to 30 ml 2% FCS. pH was then adjusted to 7.4 by adding 10 μl of 10% NaOH. These stock media solutions were filter sterilized and used to prepare serial (1:10 v/v) dilutions. For each serial dilution, 3 ml of the appropriate solution was added to 27 ml 2% FCS. Four controls were prepared. Control A contained 0.091 ml 20% acetic acid in 30 ml 2 % FCS; pH was adjusted to 7.4 by adding 60 μl of 10% NaOH. Control B contained 0.018 ml 20% acetic acid in 30 ml 2% FCS; pH was adjusted to 7.4 by adding 10 μl of 10% NaOH. Control C contained 3 ml of Control A and 27 ml 2% FCS. Control D contained 30 ml 2% FCS. Control A was used for the 500 nM bIGF-II test, Control B for the 100 nM bIGF-II test, Control C for the 50 nM bIGF-II test and Control D for the 10 nM, 5 nM, 1 nM, 0.5 nM and 0.1 nM bIGF-II tests. As shown in TABLE III, bIGF-II significantly stimulated L6 myoblast proliferation at the treatment concentrations tested. TABLE III______________________________________bIGF-II Cells/Cm.sup.2 Std.Treatment Conc..sup.a Mean Dev.______________________________________Test 1Tris Buffer -- 11508 11778 11643 ±135bIGF-II 26 nM 13401 12953 13177 ±224hIGF-I 1 nM 15519 15752 15635 ±1162% FCS -- 12313 12691 12502 ±189mediumTest 2Tris Buffer 8301 -- --bIGF-II 52 nM 10156 -- --hIGF-I 1 nM 10869 11004 10731 10868 ±792% FCS -- 8930 9676 9109 9252 ±121medium______________________________________ TABLE III______________________________________Test 3 Cells/cm.sup.2 Std.Treatment Conc..sup.a Mean Dev.______________________________________Control A -- 6391 6306 6039 6245 150bIGF-II 500 nM 11401 11223 10948 11191 186Control B -- 6558 -- -- 6558 --bIGF-II 100 nM 14037 13505 13905 13816 226Control C -- 8138 8383 8276 8266 100bIGF-II 50 nM 12374 11781 12488 12214 310Control D -- 9596 8836 8338 8923 517bIGF-II 10 nM 12175 11630 11348 11718 343bIGF-II 5 nM 11414 11239 10871 11175 226bIGF-II 1 nM 9916 9380 9420 9572 244bIGF-II 0.5 nM 8739 9135 9030 8968 167bIGF-II 0.1 nM 8754 8885 8697 8779 79hIGF-I 1 nM 11419 10653 10857 10976 324 10 nM 13676 13335 13926 13646 242______________________________________ .sup.a Estimated by radioimmunoassay or area under HPLC peak. EXAMPLE III This example demonstrates the ability of bIGF-II to stimulate bovine mammary epithelial cell proliferation. Specifically, bIGF-II purified as in Example I was tested in a collagen gel culture system for its ability to stimulate such proliferation. Mammary tissue from a 150-200 day pregnant, non-lactating Holstein cow was obtained at slaughter. Tissue was minced and placed in a 500 ml fluted Erlenmeyer flask containing 0.15% (w/v) collagenase (Batch #103-586; Boehringer Mannheim, Indianapolis, Ind.), 0.1% (w/v) hyaluronidase (Type 1, Sigma Chemical Co.), plus 5% (v/v) fetal bovine serum (FBS) in Medium 199 (both GIBCO). 90 ml of total solution was used per 5 gms of tissue. The dispersing solution was swirled on a gyrotory water bath at 60 rpm at 35° for 4-5 hours or until most clumps were dispersed. To remove large fragments, dispersed tissue, mixed with 0.02% (w/v) DNase, deoxyribonuclease I (Sigma Chemical Co.) was filtered through Nitex cloth (mesh size 153 μm, Tetko Co., Elmsford, N.Y.). Undigested clumps were collected and resuspended in 0.05% (w/v) pronase (Calbiochem-Behring Corp., LaJolla, Calif.) and swirled at 40 rpm at 35° for an additional 15 min. Mammary tissue was again filtered, collected by centrifugation, washed with Medium 199 and held on ice until density gradient separation. Following enzyme dissociation, mammary fragments were resuspended in 1 ml of 0.02% DNase and layered on a preformed gradient of Percoll (Pharmacia Fine Chemicals, Piscataway, N.J.), as described in Richards et al. Briefly, 30 ml of 42% Percoll were centrifuged at 20,000×g for 1 hour to generate a continuous gradient. Approximately 3×10 7 cells were layered on top of this gradient and centrifuged for 10 min at 800×g. Epithelial organoids were collected from the 1.065-1.070 g/ml region of the gradient. Cell number estimates prior to culture were made by mixing one volume of cell suspension with nine volumes of 0.2% (v/v) crystal violet in 0.1 M citric acid. Stained nuclei were counted on a hemocytometer. Basic techniques for the collagen gel culture system are described in Yang and Nandi. Collagen gel was prepared as described in Michalopoulos et al. with slight modification (Richards et al.). Briefly, 4 g sterilized rat tail collagen fibers (predominantly Type 1) were dissolved in 1 liter of sterile 0.017 M acetic acid at 4° for 48 hours. After centrifugation at 10,000×g for 60 min, the supernatant was collected and this served as the stock collagen solution. Each batch of collagen was individually titrated to pH 7.4, using solutions of 10X Medium 199 (no bicarbonate) (GIBCO) and 0.34 N NaOH in a ratio of 2:1. For culturing cells within the collagen matrix, the neutralized collagen mixture was kept on ice to prevent gelation. Epithelial organoids in a minimal volume (0.5 ml) of Medium 199 were added yielding a final concentration of 4-6×10 5 cells/ml gelation mixture. The collagen-cell suspension (0.5 ml) was overlaid on 0.3 ml of pregelled collagen in each well of a 24 well plate (Costar, Cambridge, Mass.) and allowed to gel at room temperature. After this layer gelled, cultures were fed with 0.5 ml of a 1:1 mixture of Dulbecco's Modified Eagle's (DME):Hams F-12 (DME/F-12) (GIBCO) plus 3% (v/v) FBS, 10 ng/ml mouse epidermal growth factor (EGF) (Collaborative Research, Inc., Waltham, Mass.), antibiotics (GIBCO), and the appropriate test growth factor. Cultures were incubated at 37° in 95% air-5% CO 2 and the culture medium was changed every other day. As shown in TABLE IV, the ability of bIGF-II to stimulate bovine mammary epithelial cell proliferation in the collagen gel assay system was tested in triplicate over a broad concentration range. A negative proliferation control, Basal Medium [DME/F-12+3% (w/v) FCS +EGF (10 ng/ml)], and positive proliferation controls, containing insulin at various supraphysiological concentrations, were simultaneously run. As shown in TABLE IV, bIGF-II stimulated bovine mammary epithelial cell proliferation at a statistically significant level at concentrations ranging from about 30 nM to about 100 nM. TABLE IV__________________________________________________________________________Test 1 Cell Numbers/Well (× 10.sup.4) Std. % IncreaseTreatment Conc. Mean Dev. Over Control__________________________________________________________________________bIGF-II 0.1 nM 29.5 28.8 19.9 26.1 5.4 -- 1.0 nM 30.1 24.4 29.4 27.9 3.1 -- 3.3 nM 29.0 22.4 18.6 23.3 5.3 -- 10.0 nM 35.6 41.3 38.4 38.4 2.9 30.2 33.0 nM 42.2 46.4 -- 44.3 2.9 50.2 100.0 nM 57.8 57.1 58.7 57.8 0.8 95.9Insulin 17.0 nM 31.5 35.9 34.7 34.1 2.3 15.6 170.0 nM 51.2 45.4 57.4 51.4 6.0 74.2 1700.0 nM 38.7 56.9 68.5 54.7 15.0 85.4Control.sup.a 29.4 29.7 -- 29.5 0.25 --__________________________________________________________________________ .sup.a Basal Medium In Test 2, peak HPLC material from Example I was dissolved in 20% acetic acid to an estimated concentration of 165 μM and added directly to the same Basal Medium to form two stock solutions. Stock solution 1 contained 33.6 μl of bIGF-II solution+11.1 ml Basal Media (final conc. bIGF-II =500 nM). Stock solution 2 contained 6.7 μl of bIGF-II solution+11.1 ml Basal Media (final conc. bIGF-II=100 nm). Serial dilutions were made from these stocks and tested over a concentration range of 0.1 nM to 100 nM. Control media consisted of Basal Medium plus a corresponding volume of acetic acid if necessary (an appropriate control was necessary when the growth factor addition lowered pH of the test media). All media was adjusted to neutral pH by addition of 10% NaOH. TABLE 2______________________________________ % IncreaseIGF-II Con- Cell Numbers/Well (× 10.sup.4) Std. OverConc. trol.sup.a Mean Dev. Control______________________________________100 nM 2 37.9 43 34.8 38.6 4.1 94.0%50 nM 3 35.9 38.9 37.9 37.5 1.5 76.1%10 nM 1 33.8 39.9 38.9 37.5 3.3 30.6%5 nM 1 34.8 29.8 39.9 34.8 5.1 21.2%1 nM 1 33.8 33.8 35.9 34.5 1.2 20.2%.5 nM 1 22.7 25.7 30.8 26.4 4.1 --0.1 nM 1 26.7 29.8 -- 28.2 2.1 --Controls1 29.8 31.8 24.7 28.7 3.7 --2 21.6 18.6 19.6 19.9 1.6 --3 19.6 24.7 19.6 21.3 2.9 --______________________________________ .sup.a Appropriate Control 1 = Basal Medium 2 = Basal Medium + 33.6 μl 20% Acetic Acid; pH adjusted to 7.4 with 10 NaOH 3 = Basal Medium + 6.7 μl 20% Acetic Acid; pH adjusted to 7.4 with 10% NaOH EXAMPLE 4 Restriction and DNA modifying enzymes used in the procedures described herein were from New England Biolabs (Beverly, Mass.). Except as specifically noted, the cloning and sequencing steps employed standard molecular biology procedures as described and/or referenced in Maniatis et al. (Maniatis). Genomic DNA was isolated from calf kidney as described in Maniatis, pp. 280-281. The DNA probes used in the genomic Southern analysis and screening of the bovine genomic library described below were isolated as follows: A human IGF-II cDNA clone structurally of a kind published by Bell et al. and Dull et al. was obtained as a 1.7 kilobase pair (kbp) Eco RI fragment containing the cDNA diagrammed in FIG. 1, and cloned into the plasmid vector pUC18. The insert DNA was purified away from vector sequences by digestion with the restriction enzyme Eco RI followed by size-fractionation via electrophoresis through 0.7% w/v agarose (Maniatis, pp. 150-161). The DNA was stained with ethidium bromide (1 μg/ml), visualized under long-wave UV light, and the 1.7 kbp band was excised. DNA was recovered by electroelution (Maniatis, p. 164) and further purified over elutip columns (Schleicher and Schuell, Keene, N.H.) according to the supplier's recommendations. This 1.7 kbp fragment was digested further with the restriction enzyme Rsa I to obtain the fragments diagrammed in FIG. 1. Each of these fragments was purified as described above for the 1.7 kbp fragment (Maniatis, pp. 150-164). The 340 and 515 bp fragments, believed to include the entire coding sequence for the human IGF-II prepeptide, were used in the genomic Southern analysis and screening of a bovine genomic library described below. ##STR8## From the A and B regions of hIGF-II shown in Dull et al., there were designed two synthetic oligomers which are herein designated IGF-IIA and IGF-IIB, respectively, and shown in FIG. 2. __________________________________________________________________________FIG. 2__________________________________________________________________________IGF-IIA48 49 50 51 52 53 54 55 56 57 58AA Phe Arg Ser Cys Asp Leu Ala Leu Leu Glu Thrhuman 5'TTC CGC AGC TGT GAC CTG GCC CTC CTG GAG ACG 3'probe 3'AAG GCG TCG ACA CTG GAC CGG GAG GAC CTC TG 5'1GF-11B| 1 2 3 4 5 6 7 8 9 10 11 12AA Ala Tyr Arg Pro Ser Glu Thr Leu Cys Gly Gly Gluhuman 5'GCT TAC CGC CCC AGT GAG ACC CTG TGC GGC GGG GAG 3'probe 3'CGA ATG GCG GGG TCA CTC TGG GAC ACG CCG CCC C 5'__________________________________________________________________________ These oligomers were synthesized on an Applied Biosystems, Inc. (Foster City, Calif.) DNA synthesizer Model 380 A or B. The oligomers were used to identify small subclones of the genomic clone which contained exon sequences, and in the case of IGF-IIB, as a primer for DNA sequencing. Genomic blots of bovine kidney DNA were done using a modification of the method of Southern. In that modification, 20 μg bovine kidney DNA was digested with Eco R1, Bam HI or Hind III, fractionated on a 20×13.5 cm 0.7% (w/v) agarose gel, stained with ethidium bromide (1 μg/ml) and photographed. The DNA was denatured for two hours at 37° in 0.5 N NaOH/1.5 M NaCl, neutralized for an additional two hours at 37° in 0.5 M Tris-HCl(pH 8)/1.5 M NaCl, and transferred overnight onto Schleicher and Schuell nitrocellulose filters in 10X SSPE (lX SSPE is 180 mM NaCl, 10 mM sodium phosphate, pH 6.8, 1 mM EDTA, all from Sigma Chemical Co.). A sponge was used instead of a paper wick. The filters were washed briefly in 10X SSPE, air-dried, baked for 2-3 hours at 80° in a vacuum oven and soaked for one hour at 50° in 5X SSPE. Denhardt's was added to a final concentration of 5X (lX Denhardt's is 0.02% w/v bovine serum albumin, 0.02% Ficoll, 0.02% polyvinyl pyrrolidone, all from Sigma Chemical Co.) and the filters were soaked an additional hour. The blots were prehybridized overnight at 37° in 25 ml of a mixture containing 50% (v/v) formamide; 5X SSPE; 5X Denhardt's; 0.1% (w/v) SDS (sodium dodecyl sulfate); and 100 μg/ml each of carrier salmon testes (ST) DNA and yeast tRNA. Prior to addition, the ST DNA and tRNA were denatured by boiling for 10 minutes. Probes were radiolabelled by nick translation (Maniatis, p. 109) to a specific activity of 10 7 -10 8 dpm/μg. Between 10; and 3×10 8 dpm of the appropriate nick-translated probe was added to the prehybridization mixture, which was then incubated for 48 hours at 42°. The filters were washed twice for 15 min at 42° in 1X SSPE/0.1% SDS, followed by a final wash (10-15 min) at the same temperature in 0.1X SSPE/0.1% SDS. The filters were air dried, and exposed to Kodak XAR film at -70° for 2-3 days with one intensifying screen. Results of a bovine genomic Southern analysis carried out with the 340 bp and 515 bp nick-translated probes (FIG. 1) are in TABLE V. TABLE V______________________________________Length of Band (kbp) 340 bp Probe 515 bp Probe______________________________________Eco RI 4.4 4.4BAM HI 6.0 8.2HIND III 13.5 13.5______________________________________ The length of each hybridizing band was determined by measuring the distance of the band from the top of the gel compared to standard DNA's of known length electrophoresed on the same gel. Results indicated that the entire coding sequence of bIGF-II could be found on a 4.4 kbp Eco RI fragment. A genomic library containing Eco RI fragments of approximately this size was constructed as follows: Bovine kidney DNA was digested to completion with Eco RI and size-fractionated by electrophoresis through agarose as described above. DNA fragments 3.8 kbp to 4.8 kbp in length were excised from the gel and purified by electroelution (Maniatis, p. 164) followed by elutip column chromatography (Schleicher and Schuell). 100 nanograms of this size-selected DNA was ligated into the vector lambda gt10 from Vector Cloning Systems (San Diego, Calif.). This vector is used to clone Eco RI cut DNA fragments ranging in size between zero and seven kbp. It was obtained pre-cut with Eco RI and ready to be ligated. Ligation was carried out using standard conditions (Maniatis, p. 286). The resulting ligated DNA was packaged in vitro using Vector Cloning Systems packaging extracts. The titer of the library obtained was 1.5×10 7 plaque forming units (pfu) per μg of DNA ligated. Screening of the library was carried out as follows: 1.2×10 5 pfu were plated on C600 cells as described in Maniatis, p. 320. The phage were plated at a density of 4000 pfu per 100 cm 2 plate containing NZC Agar (NZC is 10% w/v NZ amine, 0.5% w/v NaCl, 0.2% w/v MgCl 2 and 0.1% w/v casamino amino acids, all from Sigma Chemical Co.). Plates were incubated overnight at 37°, chilled at 4° for several hours, and transferred to nitrocellulose as described in Maniatis, p. 320. Hybridization to the nick-translated 340 bp and 515 bp probes was carried out as described above for Southern genomic blots. Positive clones were selected and subjected to a second round of screening identical to the first round, with the exception that the phage density was reduced to 100-200 pfu/100 cm 2 plate. Positive clones from the second screen were plated out a third time as described, except that the phage density was reduced further to 20-50 pfu/100 cm 2 plate. Well-isolated positive clones from the third round of screening were picked and purified DNA was prepared from these plaques according to Maniatis, p. 76. The inserts were released from the lambda gt10 arms by Eco RI digestion and subcloned into pUC18 (New England Biolabs), to provide a convenient source of large amounts of the insert DNA. Plasmid DNA was prepared as described in Maniatis, p. 90. To prepare fragments of DNA containing exon sequences which were of a convenient length for DNA sequencing (less than 500 bp) the following procedure was employed: The insert DNA was digested with the restriction endonucleases Alu 1, Hae III, Pst I or Sau 3A. These digestions produce random DNA fragments of sequenceable length. Each digest was ligated at random into the sequencing vectors M13mp18 and M13mp19 from New England Biolabs. The resulting plaques, obtained after transformation into JM101 cells (Maniatis, p. 250, and Messing et al.) were screened by hybridization to either the IGF-IIA or IGF-IIB oligomers to identify the desired clones containing exon sequences. For these hybridizations the synthetic oligomers were end-labelled as described in Maniatis, p. 122. The prehybridization buffer was altered to exclude the formamide, and the concentrations of SSPE and Denhardt's were increased to 6X and 10X, respectively, as in Meinkoth et al. Hybridization was carried out at 30°-37° and the washing temperature was reduced to 37°. Filters were washed for shorter times (5-10 minutes) in 6X SSPE/0.1% SDS. DNA was prepared from plaques hybridizing to either probe as in Messing et al. The purified, single-stranded DNA was sequenced using the dideoxy technique described in Sanger et al, except that sulfur-35 labelled nucleotides (Amersham Corp., Arlington Heights, Ill.) were used in place of the P-32 nucleotides described in Sanger et al. Exon/intron junctions were identified using three criteria: Open reading frames, exon/intron junction sequences and analogy to the human cDNA sequence. In the following sequences, the identified exon/intron junctions are shown by underlining the two (adjacent) nucleotides on either side of each junction. By such sequencing, the nucleotide sequence coding for the mature bIGF-II peptide was found to be: ##STR9## Also determined by the foregoing procedure was the following DNA sequence coding for bIGF-II linked directly at its amino end to a leader of 24 additional amino acids: ##STR10## Another sequence determined by the foregoing procedure was that of the following DNA coding for mature bIGF-II linked directly at its carboxy end to an extension of 68 amino acids. ##STR11## By the foregoing procedure, there was also determined the following nucleotide sequence of DNA coding for a bIGF-II precursor including the aforedescribed N-terminal leader and C-terminal extension: ##STR12## The bIGF-II peptides produced by expression of the immediately preceding three nucleotide sequences have substantially the biological activity of bIGF-II (in general, after removal of the aforementioned leader sequence from those peptides containing same and/or suitable naturation, as required) and can be used instead of the shorter (e.g. 67 AA) peptides of this invention (in some cases advantageously) to provide biological effects like those of bIGF-II in animals. Cited Publications 1. Bala, R. M. and Bhaumick, B. (1979) Can. J. Biochem. 57:1289-98 2. Bell, G. I., Merryweather, J. P., Sanchez-Pescador, R., Stempien, M. M., Priestley, L., Scott, J. and Rall, L. B. (1984) Nature 310:775-77 3. Daughaday, W. H. et al. (1981) J. Clin. Endocrinol. & Metab. 53:282-88 4. Dull, T. J., Gray, A., Hayflick, J. S., and Ullrich, A. (1984) Nature 310:777-81 5. Gospodarowicz, D., Weseman, J., Moran, J. S. and Lindstrom, J. (1976) J. Cell Biol. 70:395-405 6. Hirs, C. H. W. (1956) J. Biol. Chem. 219:611-621 7. Humbel, R. E. (1984) in Hormonal Proteins and Peptides, ed. Choh Hao Li, Academic Press, Inc., XII:66-68 8. Hunkapiller et al. (1983a) Methods in Enzymol., C. H. W. Hirs et al., Eds. (Academic Press, New York, N.Y.) 91:399-413 9. Hunkapiller et al. (1983b) Methods in Enzymol., C. H. W. Hirs et al., Eds. (Academic Press, New York, N.Y.) 91:486-493 10. Kotts, C. E. (1984) Ph.D. Dissertation, Univ. of Minnesota, St. Paul, Minn. 11. Kotts, C. E. and Baile, C. A. (1985) Fed Proc. 44(3):484 12. Larsen, B. R. and West, F. G. (1981) J. Chromato. Sci. 19:259-65 13. Lehninger, A. L. (1976) Biochemistry, 2nd Ed., Worth Publishers, Inc. New York, N.Y., pp. 72-75, 315-322 14. Liberti (1975) Biochem & Biophys. Res. Comm. 67:1226-1233 15. Maniatis, T., Fritsch, E. F. and Sambrook, J. (1982) in Molecular Cloning: A Laboratory Manual (Cold Springs Harbor Laboratory, Cold Springs Harbor, N.Y.) 16. Marquardt, H. et al. (1981) J. Biol. Chem. 256:6859-63 17. Meinkoth, J. and Wahl, G. (1984) Anal. Biochemistry 138:267-84 18. Messing, J., Crea, R. and Seeburg, P. H. (1981) Nucl. Acids Res. 9:4173-88 19. Michalapoulos, G. and Pitot, H. C. (1975) Exp. Cell Res. 94:70-78 20. Richards et al. (1983) J. Tissue Cult. Methods 8:31-39 21. Rinderknecht and Humbel, E. E. (1978) FEBS Letters 89:283-86 22. Sanger, F., Nicklen, S. and Coulson, A. R. (1977) Proc. Natl. Acad. Sci. USA 74:5463-67 23. Southern, E. M. (1975) J. Mol. Biol. 98:503-17 24. Strain, A J., Hill, D. J., Swenne, I., and Milner, R. D. G. (1986) British Endocrine Society Abstracts, Abs #142 25. Svoboda et al. (1980) Biochemistry 19:790-97 26. Van Wyk, J. J. et al. (1975) Adv. Metab. Disorders 8:127-50 27. Woo, S. L. C. (1979) Methods in Enzymol., R. Wu, Ed. (Academic Press, New York) 68:389-95 28. Yaffee, D. (1968) Proc. Nat'l. Acad Sci., U.S.A. 61:477 29. Yang, J. and Nandi, S. (1983) Int. Rev. of Cytol. 81:249-86 30. Yamashiro, D., and Li, C. H. (1985) Int. J. Peptide Protein Res. 26:299-304 31. Zumstein, P. P. and Humbel, R. E. (1985) Methods in Enzymology, L. Bimbaumer et al., Eds. (Academic Press, New York, N.Y.) 109:782-98

This invention relates to novel peptides having utility for promotion of growth and/or lactation in animals, to processes and DNA useful in production of such peptides, and to methods utilizing such peptides to promote growth or lactation in animals. In some embodiments, the invention is directed to peptides having bovine IGF-II biological activity, to production of such peptides, and to their use in effecting proliferation of certain cells (e.g. mammary epithelial or muscle) or in enhancing lactation in cattle or other animals.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a National Stage application of International patent application PCT/EP2013/069383 filed on Sep. 18, 2013, which claims priority to German patent application No. 2012018384.4 filed on Sep. 18, 2012, the disclosures of which are incorporated herein by reference in their entirety. TECHNICAL FIELD The present invention relates to a composite application device for the application of flowable light-polymerizable composites. The present invention relates to a composite application device according to the preamble of claim 1 , as well as a method according to the preamble of claim 23 . Definitions and Abbreviations Polymerization: Conversion of the composite which is still plastic or flowable into a solid state in which it can withstand occlusal loads. Carpule: Off-the-shelf container filled with composite material from which the composite material can be expressed using a piston. The carpule can be provided with a short or elongated squirting tube 1 . Cavity, tooth cavity: Hollow space in dental technology, in dentures and tooth crowns. Cavity wall: Tooth structure which confines the hollow space of a cavity. Composite, filling material, composite material: Material which serves to fill cavities and which seals these cavities tightly and permanently. Measuring unit: Device for measuring the amount of composite applied per unit of time. Control unit: Device for controlling the light intensity of the inventive light source depending on the amount of composite applied per unit of time. The control unit processes the data of the measuring unit and controls the light intensity of the light source. Tensile stress: Mechanical stress which stresses the bonding at the contact surface between the cavity wall and the composite and which can destroy the bonding upon exceeding the strength of the bonding. BACKGROUND OF THE INVENTION In restorative and preventive dentistry, filling cavities, dental defects or root canals of teeth is of special importance. Apart from a plurality of different materials (e.g. gutta-percha, amalgam, gold), composites are also used as filling materials. Composites are mixtures of a polymerizable plastic matrix with organic and inorganic filling materials. The polymerization of these composites is triggered by exposure to visible blue or ultraviolet light after the composites have been applied into the cavity. Thus, the method which is currently common is comprised of first applying the composite into the cavity and subsequently hardening the composite by exposure to light. All composites tend to form gaps due to their shrinkage behavior during hardening such that in case of the formation of a gap the tooth cavity will not be hermetically sealed. Due to this lack of hermetic sealing of the tooth cavity bacterial infestation of the gaps is possible and thus new caries and pain can be caused. STATE OF THE ART The disadvantage of all known light-polymerizable composites is that they shrink upon hardening. If the composites are adhered to the walls of the cavity, then this bonding is subjected to tensile stress after the hardening process. If this tensile stress is sufficiently large to exceed the strength of the bonding, the bonding will break and a gap will be formed between the filling and the tooth. There are two basic approaches to reduce the shrinkage of the applied composite during and after the hardening process: On the one hand, by applying the composite more slowly and in layers, and on the other hand, by changing the chemical composition of the composite. Both approaches have significant disadvantages: A known process of reducing tensile stresses acting on light-polymerizable composites is to introduce the composites into the cavity which needs to be filled one after the other in small amounts (having a layer thickness of about 1.0 to 2.0 mm), and to harden every layer separately by light exposure. Every new layer can only be applied when the previous layer has hardened. This process is very labor-intensive and time-consuming. The patient concerned has to hold out on the dental chair in an uncomfortable position and a bacterial contamination of the cavity that has not yet been filled to completion is the more likely, the longer it takes to fill the cavity. By the use of particularly light-sensitive and translucent composites, layer thicknesses of up to 4.0 mm are possible. This means that the cavity can be filled more rapidly; however, the larger the layer thickness is, the larger the stresses will become during hardening. In the second approach to reduce shrinkage during or after the hardening of the applied composite, the number or density of the new bonds between the monomer molecules which are formed during polymerization is reduced such that altogether polymerization shrinkage is reduced. However, this method has the substantial disadvantage of a considerably reduced strength of the composite due to the reduced number of chemical bonds. Another solution comprises the opening of bonds of ring molecules during the polymerization reaction in addition to the formation of new bonds such that in addition to the shrinkage as a result of the polymerization, an expansion of the composite takes place, too, which makes possible to partially compensate for the shrinkage. These composites which have been chemically changed have the disadvantage of only being capable of being bonded to the wall of the cavity using particular adhesion agents, and this is why they have not become established. From DE 295 17 958 U1 it is known to cure a radiation curable material using a curing lamp which is connected to the opening of the dispensing nozzle. This device is said to have the advantage of curing the exact location at which the dispensing nozzle dispenses the material. Here, the material is cured in one go, i.e. completely, and the same problems as mentioned earlier with regard to the formation of marginal gaps will arise. Furthermore, it has already been suggested to use an optically opaque, tubular dispensing element for an application tip for the application of a light-curable material to the surface of a tooth, as well as a modeling section which is translucent and disc-shaped in this case, and to expose it to light during the application. This solution takes the beginning of the light curing closer to the surface of a tooth which is basically favorable. However, the quality of the application is highly dependent on the ability of the dentist or dental technician applying the material and on the guidance of the tool. If, for instance, the tool is pressed against the cavity too strongly, the mass to be polymerized is squeezed out to the side of the application area, and if the pressure is too low, fissures and the like will not be filled with material. In addition, with regard to the formation of marginal gaps the above mentioned disadvantages arise as a result. SUMMARY OF THE INVENTION The task of the present invention is to provide a device and a method for the application of flowable light-polymerizable composites, which enable a time-saving processing of light-polymerizable composites and reliably prevent the formation of gaps of the composite during the polymerization process for the filling of cavities. This task is inventively solved by the appended claims. Extensive studies on the origins of stresses during the hardening process of composites have found that a large part of the shrinkage which is mainly responsible for the formation of stresses takes place before the composite has hardened completely. The polymerization of the composite turns the composite that has initially been plastic or flowable into a composite with a slightly deformable gel-like consistency, the so-called gel phase. This part of the shrinkage does not become effective in the filling of a cavity built up of thin layers, as in the polymerization of a thin layer the entire filling is initially transformed into the gel phase, which cannot build up stresses on its own and only then is fully polymerized. The second part of the shrinkage, the so-called post-gel shrinkage, occurs when the composite has already been polymerized, and constitutes the smaller part of the entire shrinkage. This part of the shrinkage cannot be avoided, and therefore always contributes to the formation of stresses. For thick layers, i.e. when the composite is applied in one go in a conventional manner, gel and post-gel shrinkage occurs simultaneously: While the top side of the thick layer facing the polymerization lamp has already been polymerized completely, a subjacent layer is only in the gel phase due to the light absorption of the composite. Since the surface of the thick layer has already been polymerized, composite material cannot be replenished from above and compensate for the shrinkage of the gel phase: This causes high shrinkage stresses as the shrinkages of the gel phase and the post-gel phase are accumulated. Thus, in the method according to the invention, sufficient light is supplied during the application of the composite into the cavity such that the composite flows to the walls of the cavity and the gel shrinkage is triggered immediately afterwards so that the gel shrinkage has already taken place, before the composite has been polymerized to completion by a polymerization lamp. It is especially favorable to control the light intensity already during the application of the composite such that when the composite is applied more rapidly (i.e.when larger amounts of composite are applied per unit of time) the light intensity is enhanced, and when the composite is applied more slowly (i.e. when smaller amounts of composite are applied per unit of time) the light intensity is reduced. Preferably, the inventive device consists of a combination of a spray gun or any other composite application device which serves to squeeze the composite from a suitable storage container, e.g. a commercially available carpule (preferably through the squirting tube of the carpule), and a suitable light source, for instance a light-emitting diode. The light source has to have a suitable light intensity and spectral distribution of the light wave length which is suitable to trigger the first phase of the polymerization of the composite (and thus the gel shrinkage of the composite), while the composite is applied into the cavity simultaneously. By means of a suitable device (the inventive measuring unit), the amount of the composite applied per unit of time is measured and transferred to the inventive control unit as a measured value. The control unit uses said measured value to control the light intensity of the light source. A potentiometer is preferably used as a measuring unit, especially preferably a sliding potentiometer. The inventive light source emits light while the cavity is filled with composite depending on the amount of the composite applied per unit of time. In addition, the inventive light source can continue to emit light even after the cavity has been filled with composite in order to achieve the final strength of the composite. While the cavity is filled with composite material, the inventive light source can advantageously emit light colors which do not contribute to a polymerization of the composite. Preferably, light colors are used which can be perceived by the human eye and which enable the treating person (dentist) to gain a better overview of the treatment site (cavity, tooth and its environment). Advantageously, these light colors can be switched on and off independently of the application of the composite. The light source can be supplied with electricity by one or several batteries or accumulator batteries or by connecting the inventive device with the grid. The inventive application of the composite requires the composite to be flowable to a certain degree in an unexposed state such that when the cavity if filled with the composite, the composite contacts the walls of the cavity and thus bonds to the tooth structure. For composites which are very viscous in the unexposed state and can thus not meet these requirements it is advantageous to vibrate the carpule or the squirting tube of the carpule 1 or the composite itself using a suitable sound generator in order to liquefy the composite. Depending on the material of the carpule or the squirting tube 1 of the carpule and depending on the composite used audible sound or even ultrasound vibrations can be used. According to the invention it is favorable that the fluid composite which has been applied or introduced by the application device and which still comprises numerous monomers and free radicals in this state has a relatively low viscosity and can drop into the cavity in this state and forms a thin layer. Due to the thinness, i.e. a state in which the fluid has a very low viscosity, preferably between 1.0 and 1.8 cPs, the composite will also fill small cracks and gaps in the cavity. After completion of the pre-gel phase, the composite has a tensile bending strength or bending strength of about 20 MPa in the gel state, a strength gradient being present between the surface of the corresponding layer and its deeper regions. For instance, the strength at the surface of a 2 mm layer can be 30 MPa and only 10 MPa at a depth of 2 mm. According to the invention, it is taken advantage of this strength gradient by applying pressure with the regions of lower viscosity in order to refill gaps and fissures in the cavity—be it with the help of the tool tip of the application device, or with the help of the subsequent layer. After the composite has been polymerized to completion, it still achieves a final strength of 90 to 100 MPa, and thus fulfills the EN ISO 4049 requirements for occlusal stress bearing regions, too. According to the invention, it is also favorable for transforming the composite into the gel state if the control device determines a dosage of light which corresponds to a predetermined amount of the dosage of light for a full polymerization of the respective amount of composite, wherein the gelling dosage of light corresponds to 20 to 90, preferably 40 to 65, and in particular about 50 percent of the dosage of light for a full polymerization. The polymerization time per phase, i.e. pre-gel and post-gel phase, amounts to between 1 and 10 seconds, naturally depending on the available power of the light source and the resulting exposure rate, but also on the size and shape of the composite applied per layer. In the pre-gel phase the exposure rate favorably amounts to less than 100 mW/cm 2 , in the post-gel phase preferably to more than 500 mW/cm 2 . It is especially favorable to alternate the application and polymerization processes, with changes every 10 seconds, every second, or even every 100 msec. This enables a fast application without having to fear the danger of an early polymerization. For reducing the viscosity of the applied composite a heat source, for instance a heating coil which surrounds a small metallic nozzle pipe, or any other heating, for instance an induction or a microwave heating, is preferably attached to the dispensing nozzle. According to the invention, the markedly thin composite which preferably comprises microfilled complex materials as a filling material is gelled by the polymerization radiation applied. In said pre-gel phase 90% or up to 95% of the total shrinkage occurs which can amount to 1 to 6% by volume in commercially available composites. The layer which has been applied can be processed, if necessary, by the dispensing nozzle of the application device which is configured as a tool, for instance in the form of a spatula. This pressure seals the marginal gaps of the composite in the gel state. According to the invention, pressure is applied to the underlying layer by the composite conitnuing to flow, without even the use of a tool. Once the bottom layer is in the gel state, microscopically small gaps are refilled as a result of this, while at the same time the next layer is gelling and curing simultaneously as the surface stress increases. Of course, “resqueezing” the composite which continues to flow is preferably carried out with fillings in the lower jaw region, however, in the upper jaw region, too, a recompaction of the material using the dispensing nozzle is detectable. BRIEF DESCRIPTION OF THE DRAWINGS Further advantages, details and features may be taken from the following description of several exemplary embodiments in conjunction with the drawings: FIG. 1 shows a schematic view of an inventive composite application device; FIG. 2 shows a circuit diagram of a part of the control unit for the composite application device according to FIG. 1 , in the form of a block diagram; FIG. 3 shows a detailed circuit diagram of the control unit according to FIG. 2 ; and FIG. 4 shows different embodiments of the dispensing nozzle for the composite application device according to FIG. 1 in the embodiments of FIG. 4 a , FIG. 4 b and FIG. 4 c. DETAILED DESCRIPTION Close to the squirting tube of the carpule 1 a light source 2 , for instance in the form of a light-emitting diode, is attached. The light source may be attached in a fixed or detachable manner. If the light source is attached in a detachable manner, it can be removed for the cleaning of the inventive device. By actuating the lever mechanism 10 of the spray gun 3 the composite 4 is applied from the carpule 5 into the cavity 6 of the concerned tooth ( 7 ). In doing so, the measuring unit 8 is activated, for instance by moving the slide of a sliding potentiometer, thus changing the resistance of the potentiometer. This change is registered in the control unit 9 and converted into a flow of current through the light source 2 , in such a way that a larger current is produced when the lever mechanism 10 is moved rapidly than in case of a slow movement of the lever mechanism 10 such that, when the movement is faster, the light source radiates a brighter light into the cavity than in case of a slower movement of the mechanism. An exact dosage of the light dosage is required, depending on the amount of composite applied per unit of time. If the dosage of light is too high, it prevents the composite from flowing to the cavity wall by immediate gelling, if the dosage of light is too low, however, the gelling process cannot be activated. It is especially advantageous to measure the amount of composite applied per unit of time in the manner previously described, and to use it to control the light source attached to the spray gun. Here, the light source can be a light-emitting diode which is attached close to the squirting tube of the carpule 1 . The light source can also be located at any other desired location at the spray gun and light can be radiated into the cavity by means of a light guide. It is also possible to integrate the light source into the carpule itself or to integrate one or several light guides into the carpule which receive light from the light source and radiate it into the cavity close to the squirting tube. The light source must be provided with contacts or any other suitable optical or electrical connections to the control unit. Lower tensile stresses are produced as follows compared to the conventional layer technique (Table 1). TABLE 1 Processing according Processing to manufacturer's in 3 layers instructions (layer or increment (material is applied in technique, every Processing one go, subsequently layer is hardened according to Material hardened) separately) the invention SDR 6.3 MPa 5.2 MPa 3.3 MPa (Dentsply Corp.) x-tra base 8.9 MPa 7.3 MPa 7.0 MPa (VOCO Corp.) It is especially advantageous that in this type of composite processing the treating person (dentist) can introduce the composite into the cavity in good viewing conditions. While in the layer technique, the field of action must usually only be illuminated sparsely to prevent the composite from polymerizing early, here, a certain amount of light is supplied in a targeted manner such that the composite is transformed into the gel state and cannot flow away anymore. Thus, the light source may also advantageously be configured to not only emit blue light suitable for polymerization but also, for instance, white light with a high blue content, as is emitted by commercially available white light-emitting diodes. In this way it is possible to fill the cavity under good, non-dazzling illumination conditions. A composite comprising a matrix based on acrylic resins, such as HEMA or TEGDMA, is preferably used. For the inorganic phase, i.e. the filling materials of the composite, glasses such as barium-aluminum-glass, glass ceramics, silicates, or silicon dioxides can be used which comprise both a small amount of macro fillers with a form size of more than 5 mm, but to a large degree micro fillers with a form size of less than 0.2 mm. According to the invention, the large amount of micro fillers results in a good polishability. While the polymerization shrinkage in composites with a large amount of micro fillers is typically stronger, according to the invention, the formation of marginal gaps is suppressed by the formation of gel during the pre-polymerization process such that the inventively applied composites do not have the same disadvantages as previous composites with a high amount of micro fillers in spite of the extremely smooth surface which is possible in this context. For instance, the weight portion of micro fillers can amount to 30 to 50% and it is also possible to use nano particles, i.e. fillers with particle sizes of less than 20 nm. By all means, these particles can constitute up to 50% by weight, wherein it is particularly advantageous that the viscosity is not changed by these particles, i.e. remains very low. According to the invention, it is favorable if the light source 2 is switched on during the application of the composite material. As an alternative, it is also possible to alternate the application of the composite and the polymerization by switching-on the light source 2 , for instance with a change in frequency of one Hertz such that composite is applied and the light source is turned on alternately every second. In this connection, the light source can apply pulsed light, for instance at an impulse/break ratio of 1:1. The output of the light source can be adjusted by pulse width modulation in a way known without any power losses being present. The composite may, for instance, comprise camphorquinone as a photoinitiator. Preferably, the light source or at least one LED chip of the light source comprises an emission peak of a wave length of approximately 440 nm, and then the main emission range of the LED chips is between 400 and 500 nm. In an advantageous embodiment the light source 2 comprises at least one LED chip which emits visible light in the range of between 530 and 700 nm and which in this way illuminates the composite when it is applied. It is also possible to switch on the illumination radiation during the application and to switch on the polymerization radiation in application intervals. It is to be understood that laser diodes can inventively be used as light sources 2 instead of LED chips. By implementing an additional ultrasonic source in the squirting tube 1 of the carpule the viscosity of the composite can inventively be reduced during the application. Additionally or alternatively, the squirting tube 1 can also be heated in order to further reduce the viscosity and to increase the reactivity of the composite present in monomers. When the composite is heated to, for instance, 30 or 32° C., the double-bond conversion can be increased in the polymerization of the matrix. In a further advantageous embodiment, the application of the composite is supported by a mechanical drive which can be realized as an electric motor or a pneumatic pressure source. In this embodiment, the control unit 9 controls both the light source 2 and the mechanical drive. While the invention is described in the context of a spray gun as a preferred embodiment of an application device, it is to be understood that any desired other design of an application device can also be realized. For instance, a stick applicator can also be used, and the light source and the composite source can be configured remote from a handpiece such that the composite is delivered via a composite line to the handpiece of the composite application device and the light via a corresponding light guide. Initially, a pre-polymerization process takes place in the inventive application or introduction of the composite into the cavity. Here, a particular gelatinizing light dosage is applied which corresponds to between 20 and 80 percent, preferably about 50 percent of the light dosage to completely polymerize the composite. In doing so, the composite gelates, and according to the invention, if desired, finishing can be realized using the dispensing nozzle according to FIG. 4 which is configured similar to a tool. Only then, the final polymerization process takes place. Thus, the amount of the composite applied is known and the time necessary for the final polymerization can be determined via the energy balance, and applied by the light source —or by the heat source in the squirting tube 1 . It is to be understood that the filling process can inventively be implemented in two steps to form one single layer but it is also possible to repeat the pre-polymerization and final polymerization processes in a cyclical manner for every single layer. FIG. 4 a shows one possible shape of an inventive dispensing nozzle 14 . In this embodiment, the end of the squirting tube 1 is surrounded by a tool 16 . The dispensing channel 18 extends through the tool 16 which channel comprises the same internal diameter as the squirting tube 1 , or possibly a tapered cross section towards its end, the shape of which resembles a nozzle. In the exemplary embodiment illustrated, its end is located at the side of the tool 16 . The part of the tool 16 surrounding the squirting tube 1 is further surrounded by an optical system 20 of the source 2 . The optical system 20 can be a hollow tube, which is e.g. mirrored on the inside and bundles light towards the tool 16 , and thus towards the site of application. It can, however, also be provided with light guides in a way known. Preferably, the end of the optical system 20 is provided with a concave end face 20 which comprises an additional bundling effect. In this exemplary case, the optical system 20 transmits both light from the LED chips which emit polymerization radiation and light from the LED chips for illumination. In a way known, the tool 16 is made from an elastic plastic material. With the help of the working tip 24 which is configured similar to a soft spatula the surface of the applied composite can be evened out and pressed which proves advantageous for the adhesion of the composite in the cavity. A modified embodiment of the tool 16 is illustrated in FIG. 4 b . In this embodiment, the dispensing channel 18 extends through the tool 16 in a central and coaxial manner relative to the squirting tube 1 . Here too, the optical system 20 can surround the squirting tube 1 and the upper part of the tool 16 . In every case, the tool 16 is preferably an exchangeable tool. It can be configured as a disposable part, or is also cleanable. Preferably, its upper end is mounted to the squirting tube 1 such that it cannot be lost accidentally. A further modified embodiment of a tool 16 is illustrated in FIG. 4 c . Here, the tool 16 is configured so as to be coaxial to the squirting tube 1 and extends in a blunt manner subsequent to the tube. It is held by the surrounding optical system 20 , and, in turn, the dispensing channel 18 extends through it which ends at the side of the tool 16 in this exemplary embodiment to provide a very effective tool tip 24 .

The present invention relates to a device and a method for the application of composites in tooth cavities. The device consists of a spray gun with integrated lighting for light-polymerizable composites, a measuring unit and a control unit. The composites are applied under controlled, precisely dosed exposure to polymerization light. According to the invention, the composite initially runs onto the walls of the cavity or onto previously introduced filling material and then, as a result of the light exposure, is transformed into the gel state. Thus, a large part of the polymerization shrinkage of the composite occurs while the composite is still plastically deformable so that any formation of gaps is compensated by the composite continuing to flow. It is only at this point in time that a sufficiently high dosage of light is applied for complete curing to occur.

This application is the national phase under 35 U.S.C. §371 of PCT International Application No. PCT/IB99/02093 which has an International filing date of Dec. 22, 1999, which designated the United States of America and was published in English. TECHNICAL FIELD OF THE INVENTION The present invention relates to a biocompatible implant consisting essentially of a metal such as titanium, zirconium, hafnium and tantalum, or an alloy thereof, the surface of which has been modified in order to increase ,the biocompatibility. The invention also relates to a method modification of surfaces to. BACKGROUND OF THE INVENTION Titanium, zirconium, hafnium and tantalum and their alloys have a superb corrosion resistance in body fluids and are well accepted by the human body. Titanium and its alloys are therefore much used for implants. In many applications it is of utmost importance that the metal form a strong and lasting connection with the surrounding tissues and that this connection does not impair healing. This is not easy to achieve. Implant materials not giving satisfactory healing usually lead to loss of contact between the implant and tissue, often followed by complications leading to implant failure. This has given the patients severe pain and required costly medical treatment often including complicated and expensive surgery. To deal with these problems geometric modifications of implants have been applied. Increasing the surface roughness expands the area of tissue contact. Different methods including plasma spraying, sand blasting or creation of holes or grooves to establish an inter-locking effect in the bone have achieved this. Electron beam machining has been used to make surfaces that hardly can be produced with conventional machining. These latter methods can be optimised to also give additional geometrical advantages. Another method commonly used is to apply a layer of hydroxyapatite coating onto the titanium implant surface. This mineral is present in hard tissue of all mammals. All these techniques are manufacturing- and user- sensitive and it is problematic to carry out coating in a way that gives sufficient bonding between the mineral and the metal. Another serious disadvantage with these techniques is destruction of the mineral coating during applications where stress is applied to the implant. This seriously hampers applications of metal implants. In contact with oxygen titanium, zirconium, hafnium and tantalum and their alloys are instantaneously covered with a thin layer of oxide. Various techniques exist to increase the thickness of the oxide layer. Significant improvements have not been obtained so far, concerning the biocompatibility of the implant material. The oxide layer may be further treated. For example EP-A-0 264 354 describes a process for forming a coating of a calcium phosphate compound on the surface of the titanium oxide layer. In the process to obtain the desired oxide layer it is possible to use either acid treatment or formation of an intermediate metal hydride, which is then heated in order to obtain the desired oxide as a substrate for the calcium phosphate coating. Another method for treating the surface of endosseous implants is to use the process described in EP-A-0 212 929, according to which a ceramic material is thermally sprayed onto the metal surface after its been roughened with an appropriate technique. The roughening of the metal surface may be obtained by e.g. thermally spraying titanium hydride onto it, but, as for EP-A-0 264 354, the titanium hydride coated implant is only an intermediate product in the process of obtaining the desired end product, in this case the ceramic coated implant. SUMMARY OF THE INVENTION The object of the present invention is to provide an implant with improved biocompatibility compared to known implants. This is obtained by modifying the surface of the implant. The modified surface further promotes contact between tissue ant implant. In the research work leading to the present invention it was surprisingly observed that implants coated with titanium hydride led to a better adherence between the metal and bone, compared to other titanium implants. The fact that titanium hydride coated implants could be used directly is very surprising; up to the present invention it has been considered necessary to coat hydrided surfaces to achieve satisfactory biocompatibility. In the work leading to the present invention it was demonstrated in animal models that tissues in contact with the titanium hydrided titanium surface was healthy and showed no foreign body reactions as examined by microscopy. The present invention thus relates to biocompatible metallic implants, characterized in that the surfaces of the implants have been modified so that they comprise a metal hydride layer. The invention also relates to a method for the production of a biocompatible implant, wherein a core of metal or an alloy thereof is coated with a surface layer of hydride. The characterizing features of the invention will be evident from the following description and the appended claims. DETAILED DESCRIPTION OF THE INVENTION As stated above, the invention relates to a biocompatible implant consisting essentially of metal or an alloy thereof, characterized in that the surface of the implant is modified, preferably so that it comprises an outer layer, preferably essentially consisting of a metal hydride. The expression “biocompatible implant” used herein relates to implants suitable for introduction into the body of a mammal, and especially of a human. The implants according to the invention or implants produced with the method according to the invention are intended for introduction into all living hard and soft tissues, including bone, cartilage and teeth, and all body cavities including joints and inner ear. The hydride layer in the implant according to the invention may be any metal hydride or a mixture of several different metal hydrides. In the case of an implant of titanium or an alloy thereof the major part of the modified outer layer, i.e. more than 50%, is preferably constituted by TiH 1.924 or TiH 2 . This titanium hydride layer may also comprise small amounts of other elements and hydrides thereof. The invention also relates to a method suitable for the production of the above described biological implant. This method results in an implant surface, which comprises a layer of hydride. This may be performed either by coating with a layer of hydride, or by converting the surface into hydride. It is possible to use a commercially available implant and convert its surface to comprise a hydrided layer. It is also possible to produce the implant according to the invention, by first producing a suitably shaped core of titanium or an alloy thereof, and then accomplish the titanium hydride layer. The method according to the invention is preferably performed by treating the starting implant or core by electrolysis. The starting implant is then placed in an electrolytic bath. During the electrolysis, the starting implant will constitute the cathode. The electrolytic bath is preferably an aqueous solution of NaCl with acidic pH-value. The pH is preferably adjusted to the appropriate value by addition of HCl, H 2 SO 4 , HNO 3 , HClO 4 , or an organic acid or a mixture of two or more of these acids. The temperature of the electrolytic bath should also be adjusted. It is possible to perform the method according to the invention at ambient temperature, i.e. at approximately 20° C., however, at this temperature the reaction rate will be very slow. In order to increase the reaction rate, the temperature should be raised, preferably to at least 40° C., and most preferably to at least 80° C. The most preferred electrolytic solution for use in the method according to the invention is an aqueous solution comprising from 0,01 M to 1 M of a saturated salt solution and from 10 −5 to 10 M of at least on of the above mentioned acids. The current used to perform the electrolysis is 0.001-1000 mA/cm 2 . In order to further improve the biocompatability of the implant it is to be implanted into, it is advantageous to increase the surface roughness of the hydride layer. This can for example be done by blasting, e.g. grit blasting, before hydriding the implant. The invention will now be further explained in the following examples. These examples are only intended to illustrate the invention and should in no way be considered to limit the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS In the examples below reference is made to the accompanying drawings on which: FIG. 1 illustrates the thickness of titanium hydride layers obtained by electrolysis of titanium implants at different temperatures and pH-values (see Example 1); and FIG. 2 illustrates the forces necessary to pull out implants according to the invention compared to control implants, from the tibia of rabbits (see Example 4). EXAMPLES Example 1 Specimens of Titanium Grade 2 were carefully cleaned by ultrasonic treatment with trichlorethylene for 15 min, rinsed in ethanol, and then ultrasonic treated with ethanol for 10 min. This was repeated three times, and the specimens were then rinsed in water. The clean specimens were then cathodically polarized in a bath consisting of 0.5 M NaCl and 1 M HCl. The presence of a titanium hydride after the electrolysis was confirmed by X-ray diffraction analysis. The electrolysis was performed at different temperatures, 25° C. and 80° C., in order to study the influence of the temperature on the obtained titanium hydride layer, and also at different pH-values, pH 0 and pH 2, in order to study the influence of the pH. The thickness of the obtained titanium hydride layer was determined by microscopy of metallographic cross sections. The thickness as a function of the time used for the treatment is shown in FIG. 1 . As evident from the figure, it is preferable to use a temperature of 80° C. compared to a temperature of 25° C. Example 2 Experimentally produced implants were made of titanium grade 2. The implants were threaded and had a diameter of 3.5 mm and a length of 4.5 mm. The implants were made to fit the bones of rabbits. The implants were treated for 18 hours in the same bath and under the same conditions as used in example 1. After sterilization by autoclaving, these implants (Implants of the invention) were introduced by surgery in the femurs of four rabbits. These rabbits were reproduced with special care to render animals with very similar genetics. For comparison, implants that were only cleaned and autoclaved (Reference implants) were introduced in similar positions in the rabbits. Three implants with titanium hydride layers and two with cleaned and autoclaved surface were present in each rabbit. The rabbits were euthanized after 8 weeks. The adherence between the implants and the bone was recorded for eight implants with titanium hydride coating and four implants that had only been cleaned and autoclaved. The adherence was determined by measuring the torque force (Ncm) needed to loosen the implants from the femur of the rabbits. The results are shown in table 1 below. TABLE 1 Removal torque (Ncm) ± SD Mean Implants 45.1 52.5 36.2 53.5 83.2 59.1 87.6 68.2 18.0 60.7 of the invention Reference 10.2 12.3 14 17.5 — — — — 3.1 13.5 implants From the table, it is evident that the implants with a surface layer of titanium hydride had a much better adherence than those without. Histology showed normal cells in contact with titanium hydride. Example 3 Strength and stability of interface between metal and bone is critical to the long-term performance of load bearing implants in particular bone with poor quality. Data has been presented that rough surfaces induce better bone response, however the ideal type and degree of roughness remains unknown. In this example the bone response to titanium with different surface roughness expressed by bone to implant retention was investigate. A test model was developed using coin shaped commercial pure (c.p.) titanium implants. With this model, further described below, the effect of the frictional forces during pull-out test is minimised. Different surface structures were obtained by grit-blasting with TiO 2 , using different grain sizes. The implants had the shape of disks, and they were machined from a 10 mm round bar of grad 2 titanium (ASTM B 348). The size of the disks was 6,25±0,01 mm in diameter with a thickness of 2.0±0,05 mm. All disks were standardised with grinding disc from #800 to #1200 grit size and polished with 6μ diamond abrasive, according to Struers® Metalog Guide before further treatments. All disks were pre-treated with trichloroethylene in an ultrasonic bath for 30 min, rinsed with ethanol then ethanol in ultrasonic bath for 3×10-min, and finally rinsed with deionized water. A total of forty-eight implants were divided into three groups: Group 1: implants with electropolished surfaces, Group 2: implants that were blasted with TiO 2 particles with a grain size of 22-28 μm, and Group 3: implants that were blasted with TiO 2 particles with a grain size of 180-220 μm. Eight implants in each group were used as controls, while the other eight in each group were treated according to the invention. Four implants, one from each group were randomly in-operated into the tibial bone of each of the twelve New Zealand White rabbits. Before surgery, the rabbits were given Fentanyl/fluanison (Hypnorm®) 0,05-0,1 ml/kg s.c. 10 minutes prior to being removed from their cages. The operation sites were depilated and washed with soap and ethanol prior to a sterile cover of the lover part of the rabbit. The rabbits were anaesthetised with Midazolam (Dormicum®) 2 mg/kg bw i.v. If the animals started to show signs of waking up between 0,1 to 0,5 diluted Hypnorm® (1 ml Hypnorm® and 9 ml sterile water) was injected i.v. slowly until an adequate effect was obtained. Local-anaesthesia, Lidocain (Xylocain/adrenaline®) 1,8 ml s.p. in joint site, tuberositas tibiae, was used. The animals were placed on the operation table on their back, covered with sterile cloths prior to disinfection with 70% etanol. Their eyes were protected for drying with ointment. Two implants were placed in each proximal tibia. An incision of 5 cm was made on the medial-anterior part of tibiae, starting approximately 2 cm from patella. The incision penetrated epidermis, dermis and the facial layers. Lateral reflection of these tissues exposed the underlying periosteum. Additional medial-anterior incision was made through the periosteum. A 1,0-mm diameter twist drill (Medicon®) in a handle was used to get two guide holes with 8 mm distance. A 6,65 mm diameter stainless steel bur in a slow-speed handpiece with physiological saline solution irrigation was used to get flat cortical surfaces for the implants and the individually fitted Teflon caps, which were used to cover the implants to prevent bone overgrowth. Care was taken to prevent breaching the cortical bone. Two implants were placed on the even prepared surface of the cortical bone. To stabilise the implants a titanium-plate (Medicon® CMS) in proximal-distal direction, were retained with two titanium screws. The facial layers were repositioned and sutured with 4-0 polyglycolic acid suture. The superficial layers were sutured using an intra cutanos technique with the same 4-0 suture. After surgery, each animal received an injection with 20 ml NaCl infusion s.c. and 0,05 mg Temgesic® “Reckitt & Colman” 0,02-0,05 mg/kg s.c. As post op analgesic the animals received 0,05 mg Temgesic® for four days. Observation time was set for 8 weeks. The fixation of the implants to bone was then evaluated using a pull-out test. The rabbits were sacrificed with an over-dose i.v. and an intracardiac injection with Pentobarbital (Mebumal®) while under sedation with Hypnorm®. Immediately after euthanisation the superficial tissues overlying the implants were removed to expose the Teflon caps. The titanium plate was carefully removed and the Teflon cap separated from the implants using pressure-air. Tibia was cut in the knee joint and fixated in a special designed jig, which was anchored to the bed of the testing machine to stabilise the bone during the pull-out procedure. A metal pin with a “ball” in one end and threads in the other was fastened in pre-threads implants. The equipment used to apply pull-out force was Lloyds LRX Materials Testing machine. The ball-attachment on the metal pin was fit in a holder connected to a load cell of 500 N. This attachment was designed to avoid any shear and tilt forces on the implant and tolerates for the axis of the implant not being precisely perpendicular on the bone surface. Crosshead speed range was set to 1,0 mm/min. Force measuring accuracy was set to +/−1%. The results of the pull-out test are shown in FIG. 2 . It is evident that the implants according to the invention, i.e. the implants with hydrided surfaces, showed a better bone fixation than the controls.

An implant with a surface modified for improved bio-compatiability consisting of a metal or an alloy thereof, said implant surface comprising a modified outer layer is disclosed, wherein said metal preferably is titanium, zirconium, hafnium or tantalum, and most preferably titanium, and said modified outer layer preferably comprises a hydride of said metal. Also a method for the production of such an implant is disclosed.

BACKGROUND OF THE INVENTION The present invention relates to an apparatus for heating water for producing a hot water and steam mixture and a cleaner utilizing the mixture. The apparatus further recovers dirty water from the article being cleaned and recovers heat from the dirty water to preheat incoming fresh water. Steam cleaning devices are becoming very popular for use in cleaning a wide variety of items, especially rugs, but also including upholstery, fabric covered furniture and the like. Because many of the items to be cleaned are permanently installed or difficult to move, the steam cleaning apparatus must usually go to the site where cleaning is to occur. Consequently, the apparatus for many modern cleaners of this type is truck mounted. Throughout the day a truck mounted cleaning unit will be required to produce a substantial amount of high pressure hot or even super heated water and/or steam. Normally, this water is originally supplied to the truck at the site of the cleaning through a hose, but may be carried to the site, if water is not available. As this water is usually at an ambient temperature or cooler, the water must be heated substantially by the apparatus in order for it to be usable. One of the most common ways of heating water for this purpose is by means of a hydrocarbon fueled internal combustion engine. In particular, heat produced by the engine, especially the exhaust is transferred to the water. However, a substantial amount of the heat generated by the engine is wasted making it difficult for even a large engine to produce enough heated water to keep up with a heavy demand which in turn slows work or requires replacement of the engine with a larger engine having a greater purchase cost and a greater operating cost. Consequently, it is desirable to make highly efficient usage of a smaller engine with a relatively low operating cost. One of the inefficient features of the prior art devices used for this purpose has been that, while exhaust has been used to heat the water, the heat exchanger for heating the water with the exhaust is normally substantially removed from the engine exhaust parts. This is done to allow the exhaust gas to cool in the exhaust manifold before entering the heat exchanger, as the gas directly exhausting the manifold are hot enough to melt or deform conventionally used heat exchangers. Secondly, once the exhaust gas leaves the primary heat exchanger it is normally simply wasted. Thirdly, waste water and steam that are recovered by vacuum after cleaning are not used further and the residual heat therein is wasted. Fourthly, the waste water returning from the cleaning process with dirt and the like is drawn by a vacuum compressor. When operating under a load, especially heavy loads, the vacuum compressor further heats the air, water and steam being drawn through the compressor. In conventional systems this heated air and water is wasted. SUMMARY OF THE INVENTION An apparatus is provided for producing a heated water and steam mixture for use in cleaning operations. The apparatus includes primary heat generating means that is preferably a gasoline powered internal combustion engine; a water supply system for supplying tap water to the apparatus; a first heat exchanger apparatus for preheating the tap water with a secondary exhaust gas stream, heat recovered from waste water and steam and heat generated by a vacuum generator; a second heat exchanger for producing the mixture by heating the preheated water with exhaust gas directly from the engine; a cleaning wand assembly for delivery of the heated water and steam mixture to a cleaning head; vacuum generator means for recovering dirty water and steam after use and collection means which is preferably a tank for collecting dirty water. OBJECTS AND ADVANTAGES OF THE INVENTION Therefore, the principal objects of the present invention are: to provide a mobile heated water cleaning apparatus that efficiently utilizes heat produced by an internal combustion engine to heat water for use by the apparatus; to provide such an apparatus that provides primary heating of the water through a heat exchanger that is configured and constructed to transfer heat to the water from exhaust gas directly at the exit of the exhaust gas from the engine; to provide such an apparatus including a secondary heat recovery system; to provide such an apparatus wherein the secondary heat recovery system utilizes heated gas exiting the primary exhaust gas heat exchanger to preheat the water; to provide such an apparatus including a vacuum compressor to recover spent water and steam and wherein heat generated by the compressor is recovered to preheat the water; to provide such a secondary heat recovery system that further recovers heat from spent steam and water to preheat fresh water; to provide such an apparatus that efficiently utilizes the heat produced by an engine so as to reduce original engine size and cost as well as operating cost; and to provide such an apparatus that is easy to use, economical to operate and especially adapted for the intended usage thereof. Other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a diagrammatic top plan view of a cleaning apparatus in accordance with the present invention showing a heated water generating unit, a dirty water recovery tank and a cleaning wand with hoses. FIG. 2 is a schematic view of the cleaning apparatus. FIG. 3 is a perspective view on an enlarged scale of the heated water generating unit. FIG. 4 is an enlarged and partially schematic top plan view of the heated water generating unit, taken along line 4--4 of FIG. 3 with detail simplified to better illustrate certain elements thereof. DETAILED DESCRIPTION OF THE INVENTION As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. The reference numeral 1 generally designates a hot water or steam cleaning apparatus mounted within a van 2. The steam cleaning apparatus 1 generally includes a support frame 5 (FIG. 5) upon which is mounted an internal combustion engine 6 (FIG. 1) and a cleaning fluid heating assembly 7. The steam cleaning apparatus 1 further includes a water source 10, a cleaning wand assembly 11 and collection means such as the illustrated dirty water collection apparatus 12. As can be seen in FIG. 3 the support frame 5 with the internal combustion engine 6 and heating assembly 7 are mounted in the cargo bay area 15 of the van 2. Also mounted in the cargo bay area 15 is the dirty water collection apparatus 12. As is shown in FIG. 1, while in use, a side door 16 of the van is opened and the water source 10 is run from an available source of water to the fluid heating assembly 7. Likewise the wand apparatus 11 is removed from the van 2 and taken to the site to be cleaned. In this manner, principally only the wand apparatus 11 and water source 10 must be removed from the van 2. Subsequent to use, the wand assembly 11 and water source 10 may be returned to the van 2 for storage in the cargo area 15. The support frame 5 (FIG. 3) is in general a sled type structure having a rectangular base 19, upright struts 20, and cross beams 21 supported by the tops of the struts 20. The structure of the support frame 5 is securely fastened together by welding, bolts or the like. Also utilized in the apparatus for support are interconnected C-clamp supports 22. Mounted on the front of the base 19 is a control and switching station 25. The switching station 25 is mounted in such a manner as to extend forward of the portion of the apparatus 1 supported by the frame 5 in such a way as to be easily assessable from a person standing outside the van 2. The switching station 25 includes a hot water outlet coupling 26 controlled by a valve 27 and an inlet water coupling 28. The switching station 25 also includes an inlet coupling 29 for providing lubricating oil to the apparatus 1 and an outlet coupling 30 (FIG. 1) for effectively draining oil from the apparatus 1. The switching station 25 includes a pressure indicator 32 (FIG. 2) for indicating the pressure associated with hot water produced by the apparatus 1 and a temperature indicator 33 for also indicating the temperature of the water produced by the apparatus 1. A pressure controller 34 allows control of the pressure delivered to the hot water coupling 26. The switching station 25 can include other gages as are desirable to allow an operator to monitor the operating conditions for the overall apparatus 1. Mounted on the front end of the support frame is the internal combustion engine 6. The engine 6 is of a fairly conventional design and includes a main engine body 36 (FIG. 3), control apparatus 37 for starting and controlling the speed of the engine, a fuel system 38 for supplying fuel from a gas tank (not shown) to the engine 6 and a pair of exhaust gas discharge ports 40 and 41. The engine 6 also includes a drive shaft 42 which extends rearwardly from the remainder of the engine 6. A battery 43 is electrically connected to the control apparatus 37 of engine 6 for use in starting the engine 6. A suitable engine 6 is a 22 horsepower, 2 cycle Kohler motor with an adjustable operating speed and an operating exhaust temperature at the parts 40 and 41 of approximately 1300° F. The cleaning fluid heating assembly 7 is illustrated somewhat differently in each of the FIGS. 2, 3 and 4 so as to provide as much information as possible about the assembly 7. FIG. 2 is a highly schematic diagram of the heating assembly 7 showing various components of the assembly 7 in a manner that can be easily traced, but also in a manner that is not consistent with the specific positioning of the various pieces within the assembly 7. FIG. 3 provides a more detailed drawing showing the various components in their actual setting, and FIG. 4 is a view from the top of the assembly 7 with a great deal of detail removed to show the main flow path through certain components of the assembly 7. Flow of fluid into the fluid heating assembly 7 begins at the switching station 25 wherein water is received into the apparatus 1 through the inlet water coupling 28 which connects with piping means that begins with a fluid conduit 45. The fluid conduit 45 flow connects with a shell side 44 (shell interior chamber surrounding tube of exchanger) of a first heat exchanger 46. The water exits the heat exchanger 46 through a fluid conduit 47 and enters a water pump 50. The water pump 50 draws the water through the water flow system to that point and applies pressure to the water through a control valve 49 so as to initiate pressurization of the water in the heating assembly 7. The water leaves the water pump 50 through a fluid conduit 51 and enters a shell side 53 of a second heat exchanger 52. The water exits the heat exchanger 52 through a fluid conduit 54 and enters a shell side 56 of a third heat exchanger 55. The water flows through the heat exchanger 55 and exits through a fluid conduit 57 which connects to the hot water outlet coupling 26 of the switching station 25. The exchangers 52 and 55 are sequential in water flow path but are effectively both subexchangers or parts of the primary heat exchanger of the system, whereas the exchanger 46 is considered a secondary exchanger. The fluid conduit 57 is constructed of material suitable for withstanding relatively high temperatures and pressures of the water within the conduit 57. Preferably, the water is at approximately 30 pounds per square inch pressure and from 140° to 240° F. in temperature in the conduit 57. At the upper temperature range much of the fluid mixture therein will be released as steam whereas at the lower range most of the mixture will be hot water. A first bypass conduit 59 (FIGS. 1 and 2) connects to the conduit 57 and includes a temperature control valve 61 which relieves to allow flow through the entire water system to that location thereby bringing in relatively cool makeup water and preventing overheating of the fluid within the conduit 57. That is, if the fluid in the conduit 57 reaches a preselected temperature, the temperature control valve 61 opens releasing fluid through the bypass conduit 59 into the collection apparatus 12. A second bypass conduit 63 also flow connects between the conduit 57 and the collection apparatus 12. Flow through the bypass conduit 63 is controlled by a pressure control valve 64 in such a way that pressure within the conduit 57 is controlled to maintain the pressure in conduit 57 below a preselected pressure. That is, if the pressure in the conduit 57 reaches the preselected pressure, then the pressure control valve 64 opens to relieve water from the conduit 57 into the collection apparatus 12 and thereby release the pressure in conduit 57. Also connected to the fluid conduit 47 is a chemical addition conduit 66. The chemical addition conduit 66 is in turn connected to a chemical addition tank 67 through a pump 68. A flow control valve 69 is also placed along the chemical addition conduit 66 to control flow of fluid through the conduit 66. In this manner cleaning chemicals, such as are conventionally used in the industry, can be added to the water being heated by the heating assembly 7 so as to be metered into the conduit 47 just prior to the water pump 50. As is seen in FIG. 3, the water pump 50 includes drive pulley 73 connected by a drive belt 74 to a power take off pulley 75 that is mounted on and rotates with the output drive shaft 42 of the engine 6. Tubes 78 and 79 (FIG. 4, inside respective shells) of the second and third heat exchangers 52 and 55 are directly mounted on the exhaust gas discharge ports 40 and 41 respectively of the engine 6. The tubes 78 and 79 are bayonet type construction and have interior passageways 80 and 81 (also referred to as tube side of a heat exchanger) respectively that are substantially uniform in cross section and free of obstruction through the entire length of the heat exchangers 52 and 55. In this manner the heat exchanger interior passageways 80 and 81 receive hot exhaust gas directly from the engine in a manner that prevents substantial cooling of the gas prior to entry of the heat exchangers 52 and 55. The tubes 78 and 79 as well as the passageways 80 and 81 associated therewith extend straight out from the respective exhaust ports 40 and 41. That is, the passageways 80 and 81 are generally perpendicularly aligned with respect to the ports 40 and 41. The heat exchanger tubes 78 and 79 are constructed of a metal that is suitable for withstanding the heat of the exhaust gases without substantial warping or damage. Preferably the tubes 78 and 79 are constructed of 304 stainless steel. The engine exhaust gases exit the heat exchangers 52 and 55 through a pair of gas conduits 84 and 85 respectively. A vacuum conduit 87 (FIGS. 1 and 2) connects the dirty water collection apparatus 12, which will be discussed later, with a vacuum generating means, such as the illustrated vacuum compressor 88 which effectively creates a vacuum or suction within the vacuum conduit 87 and draws gases therethrough. It is foreseen that other types of vacuum producing devices such as a blower could be used for this purpose. The gases drawn through the compressor 88 exit through a conduit 89. The conduit 89 merges with the exhaust gas conduits 84 and 85 at junction 90 so as to mix the gases passing through the conduit 89 with the gases in the conduits 84 and 85 which are then conveyed by a conduit 91 to the entry of a tubular passageway 92 (FIG. 4, tube side) of the heat exchanger 46. The gas exits the first heat exchanger 46 and passes into a bifurcated exhaust conduit 95 which conveys the gas to a pair of mufflers 96 and 97. Each muffler 96 and 97 exhausts through an exhaust port 98 and 99 respectively to the atmosphere. The compressor 88, in the same manner as the water pump 50, is driven by the drive shaft 42 of the engine 6. In particular, a drive pulley 101 (FIG. 3) mounted on the drive shaft 42 is connected to and effectively operates the compressor 88, through a drive belt 102 rotating a pulley (not shown) of the compressor 88. The compressor 88 is mounted on the support frame 5, as is seen in FIG. 3. An oil line 104 is secured to the compressor 88 and allows selective draining of oil from the compressor to the oil outlet coupling 30 (FIG. 1) on the switching station 25 in a manner controlled by a valve (not shown). Likewise oil can be injected into the vacuum conduit 87 just prior to entry into the compressor through an oil line 105 (FIG. 2) controlled by a valve 106. The oil line 105 is connected to the inlet oil coupling 29 on the switching station 25 and allows oil to be injected into the compressor at the end of the working day to provide lubrication and reduce corrosion of the interior of the compressor 88. The fluid heating assembly 7 is covered by a cover 108, seen in FIG. 1. It is also noted that the supports 22 join the heat exchangers 52 and 55 to help maintain proper spacing and help prevent vibration. The conduits 84 and 85 are also preferably constructed of a rigid tubing to help support the exchangers 52 and 55. The water source 10 shown in the illustrated drawings is a hose 110 of a conventional type which is suitable for hooking up to an outside water faucet or the like. Normally during the use of the apparatus 1 the water source hose 110 is joined at one end thereof to the water inlet coupling 28 and to a water outlet on a house or the like at the opposite end. The hose 110 is in this way continuously able to supply water to the apparatus 1 as needed. It is foreseen that in some instances cleaning must be done at a site where a water source is not readily available. In such situations an additional water storage tank will be carried in the van cargo area 15 to supply water to the hose 110. The cleaning wand assembly 11 is effectively the apparatus that is actually taken to the site where cleaning is required. For example, the cleaning wand assembly 11 may be used in conjunction with the cleaning of a rug 111 (FIG. 1) at a house or at a commercial installation, furniture, drapery or the like. The wand assembly includes a head 112 attached to a handle 113. The head includes an interior spray nozzle 114. A hot water hose 116 connects the hot water outlet coupling 26 of the switching station 25 to the nozzle 114. An intermediate valve controlled by a hand actuator 118 controls the amount of fluid allowed to pass through the hose 116 and out the nozzle 114. It is foreseen that for certain applications a wide variety of heads, nozzles or other distribution devices could be utilized for the illustrated head. A vacuum reclamation line 120 is connected to the head 112 and opens to the interior of the head 112. The vacuum reclamation line 120 includes a valve which is controlled by a hand actuator 121 located on the handle 113. The end of the reclamation line 120 opposite the head 112 is connected to and opens into a tank 125 of the dirty water collection apparatus 12. The collection apparatus 12, as noted, includes a collection tank 125 for collecting water drawn through the vacuum reclamation line 120 by the compressor 88. The tank 125 includes a clean out drain 126 controlled by a valve 127. The tank 125 includes a opening 128 in the top thereof normally covered by a lid 129 to allow an operator to clean the tank. Preferably the interior of the tank includes baffles arranged to induce water drawn through the reclamation line 122 to remain in the tank 125 as gases are drawn therefrom by the compressor 88. During operation of the apparatus 1, water is drawn through the hose 110 into the first heat exchanger 46 by the water pump 50 where the water is heated by secondary heat sources which include residual heat in the exhaust gases entering the heat exchanger from conduits 84 and 85 and heat contained within the gases entering the heat exchanger from the vacuum compressor 88. The gases from the vacuum compressor 88 include steam and/or water vapor withdrawn from the material being cleaned which has passed through the reclamation line 120 as well as heat produced within the vacuum compressor 88 itself. Typically, the temperature of the gases from the compressor is in the range of from 110° to 120° F. with a maximum of about 240° F. In particular, when the vacuum compressor 88 is working hard, the gases passing therethrough are substantially heated and conveyed through the conduit 89 to mix with the residual exhaust gases to enter the first heat exchanger 46. The temperature of the exhaust gases in the conduits 84 and 85 is typically in the range from 600° to 800° F. Heat is transferred from the combined gases which pass through the conduit 91 into the first heat exchanger to the water in the shell side 44 (FIG. 4) thereof to preheat the water. The water is then pumped by the pump 50 into the shell side 53 of the second heat exchanger 52. While passing through the second heat exchanger 52 the water is substantially heated by the exhaust gases exiting the engine through discharge port 40. The water then passes into the third heat exchanger 55 and passes countercurrent to the exhaust gases exiting the engine 6 through discharge port 41, so as to be heated thereby. The water is heated so as to be in the range between 140° and 240° F. Preferably the water is finally heated to approximately 230° and about approximately 30 pounds of pressure. The heating assembly and, in particular the conduit 57, is protected against too great a temperature or pressure by preselected settings of the temperature control valve 61 and pressure control valve 64. The heated water leaves the fluid heating assembly 7 through the hot water outlet coupling 26 and passes into the hot water outlet hose 116 for conveyance to the wand assembly 11. At the wand assembly 11 the hot water is sprayed through the nozzle 114 under control of the hand actuator 118 so as to be sprayed on the material to be cleaned such as carpeting or the like. Once sprayed, the vacuum reclamation line is actuated so as to pull the vacuum on the interior of the head 112 to withdraw excess condensed water, dirt and excess steam from the material being cleaned. The vacuumed materials are drawn through the reclamation line 120 to the tank 125 wherein at least part of the condensed water and dirt are preferably allowed to accumulate at the bottom of the tank 125 while steam, water vapor and other gases are drawn through the compressor 88. The gases passing through the compressor are further heated by the work of the compressor 88 and discharged into the conduit 89. The exhaust gases that have passed through the heat exchangers 52 and 55 join with the exhaust of the compressor 88 at the junction 90 and are passed through the first heat exchanger 46 for preheating the water as previously described. The gases then pass through mufflers 96 and 97 so as to discharge into the atmosphere. The present invention allows preheating of the water with heat withdrawn from the exhaust gases that has not been completely withdrawn by the primary heat exchangers which are the second heat exchanger 52 and the third heat exchanger 55. The system also allows recovery of the heat which exists in the gases exiting the compressor 88 which is produced both by internal work of the compressor 88 and by recovery of steam and the like from the carpet or other object being cleaned in the secondary heat exchanger which is heat exchanger 46. In this manner the heat produced by the system is very efficiently used to produce new hot water for the use in cleaning without wasting a substantial amount of the heat which would otherwise be wasted to the atmosphere. The present system also allows for the very effective exchange of heat between the exhaust gases exiting the engine and the water being heated thereby. In particular, the heat exchangers 52 and 55 for exchanging heat between the water and the exhaust gases are placed to receive the exhaust gases directly from the engine 6, so that the exhaust gases are not allowed to cool substantially before entering the heat exchangers 52 and 55. Many prior art devices of this type require the use of a substantial amount of piping between the engine and the primary heat exchangers so that the gas will somewhat cool and deform by melting the exchanger, as conventional exchangers used for this purpose are constructed of copper or other material that cannot withstand the heat of the exhaust gases directly from the engine 6. Consequently, a substantial amount of heat is wasted to the air by conduction through the conveying piping prior to entering the heat exchangers in the conventional devices. This is avoided in the present apparatus and provides for very efficient heating of the water. The combining of the recovery of the heat to preheat the water within the secondary heat exchanger 46 and the very efficient use of the second and third heat exchangers 52 and 55 allow for a high rate of production of hot water within the present system so that hot water is readily available on demand by the users even when there is a substantial load placed upon the apparatus 1. It is to be understood that while certain forms of the present invention have been illustrated and described herein, it is not to be limited to the specific forms or arrangement of parts described and shown.

An apparatus for producing heated water, including steam, to be used as a cleaning fluid, includes an internal combustion engine, a water heating assembly, a vacuum generating device, a cleaning assembly and a dirty water collector. The heating assembly includes piping and three heat exchangers. Two of the heat exchangers are located to receive exhaust gas directly from exhaust ports respectively of the engine. The third heat exchanger receives a mixture of gas which includes residual exhaust gases from the first and second heat exchangers and the output of the vacuum generator. Water is preheated in the third heat exchanger and finally heated in the first and second heat exchangers. The heated water is used at the cleaning assembly and partially reclaimed by the vacuum generator. Condensed water and dirt are collected in the collector and water vapor is further heated by and passed through the vacuum generator to the third heat exchanger.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] Not Applicable FEDERALLY SPONSORED RESEARCH [0002] Not Applicable SEQUENCE LISTING OR PROGRAM [0003] Not Applicable BACKGROUND OF THE INVENTION [0004] 1. Field of Invention [0005] This invention relates to electronic sensing and monitoring devices, specifically a wireless electronic monitor of pH and the like for aquariums. [0006] 2. Prior Art [0007] Previously, a pH measurement of water in a container such as an aquarium was done using colorimetry, a process wherein the color of an indicator chemical mixed with the water under test is compared with a chart that approximately correlates that color with a discrete value of pH. Colorimetry by its nature does not provide an output as a sensor that can be processed by electronic circuitry, and is therefore not a suitable sensor for a monitor that provides a warning when pH levels are outside of a desired range. [0008] A combination electrode of the type available from Omega Engineering of Stamford, Conn. generates a voltage dependent on ionic activity in the water, can be configured to measure pH, and can operate continuously immersed in the water being tested. The combination electrode requires a meter to be useful, and a basic meter configuration includes a display of the pH or other ionic activity and some method to calibrate the electrode with standard solutions. [0009] While the use of the combination electrode is ubiquitous in science and industry, it is not common in aquarium keeping and the like. Most typical pH measurement systems available from scientific instrument suppliers have a cable or wire and have a meter that either sets upon a benchtop or is mounted in an equipment panel. A notable exception is a handheld pH tester with the electrode and the display integrated into a compact and rugged field instrument. For a container such as a tank, the combination electrode typically penetrates the wall of the tank using a bulkhead fitting or similar to make a watertight connection. The combination electrode is not always connected directly to a meter with a coaxial cable. A transducer that converts the electrode output to a modulated current source is well known as a transmitter. Additionally, the combination electrode output can be sent through ambient air using radio waves or infrared light to a remote meter using prior art. Lastly, industrial process control applications commonly use a set-point monitor to provide a warning or alarm when the pH of a process is not within specified limits. [0010] A limitation of using a typical electrode and meter is the coaxial cable or wire connecting the two. [0011] A limitation of the typical meter and combination electrode is that there is no convenient surface to place it near a typical aquarium, or to mount the electrode. The typical scientific or industrial pH measurement equipment is not an aesthetically pleasing addition to the natural environment that an aquarium attempts to represent. [0012] A limitation of a handheld pH test meter is that the typical design is intended for sampling applications, and has neither an intrinsic means of attachment to a tank or a set-point alarm that would make it a true monitor. [0013] A limitation of measuring the pH of a liquid in a tank or container in most industrial applications is the requirement to penetrate the wall so that the combination electrode has access to the interior of the tank. [0014] A limitation of using radio waves to transmit the output of the electrode to a meter is that the antenna attached to the transmitter must be kept above the surface of the liquid within the tank if the liquid is conductive, such as saltwater. This is due to the phenomena of attenuation of an electromagnetic field in a conductive fluid. [0015] A limitation of the typical pH measurement system configured with a set-point monitor is again the industrial nature of the typical equipment available. A pH electrode would either have to penetrate the wall of the aquarium, or would have to be mounted to the lip around the edge, similar to how many aquarium heaters are attached. It is preferable to keep the electrode and the meter below the lip of the aquarium to avoid interference with the cover of the tank. OBJECTS AND ADVANTAGES [0016] Accordingly, several objects and advantages of the present invention are: 1. to provide an automatic and periodic measurement of pH in a container such as an aquarium not possible with colorimetry; 2. to eliminate the use of a coaxial cable or wires between the pH sensor and the pH display; 3. to provide a small device that can be conveniently placed anywhere on any wall of an aquarium; 4. to eliminate the need to penetrate the wall of an aquarium or similar container; 5. to provide an efficient wireless transmittal of sensor output from within a salt water aquarium that cannot be blocked by objects within the aquarium; 6. to provide an alarm when the pH of an aquarium is outside of pre-determined limits; and 7. to obviate the need to personally test the water of an aquarium regularly. [0024] Further objects and advantages are to provide a wireless pH monitor for aquariums that is simple to install and remove, provides an easy pH sensor replacement method, can be configured for remote monitoring, and can be configured for data logging of the pH sensor output. Still further objects and advantages of the present invention will become apparent from a consideration of the ensuing detailed description of the invention in conjunction with the accompanying drawings and the appended claims. SUMMARY [0025] In accordance with the present invention a wireless electronic monitor for pH in an aquarium comprising two devices that sandwich a wall of the aquarium, the interior device transmitting the output of a pH sensor through the wall to the exterior device using frequency modulated pulses of light. DRAWINGS Figures [0026] FIG. 1 shows a wireless electronic monitor in an exploded view demonstrating how it is used to sandwich a transparent aquarium wall. [0027] FIG. 2 a to 2 c show the components attached to the transmitter electronics housing. [0028] FIGS. 3 a and 3 b show the connection of the pH sensor to complete the sense and transmit assembly (STA). [0029] FIG. 4 shows the receive and display assembly (RDA) components that are attached to the receiver electronics housing. [0030] FIG. 5 shows a schematic representation of the wireless monitor configured for measuring pH in an aquarium. DRAWINGS Reference Numerals [0000] 6 pH Sensor 8 Molded Header 10 Transmitter Housing 12 Battery Cover 14 Transparent Window 15 Sense and Transmit Assembly (STA) 16 Transparent Tank Wall 18 Receiver Housing 20 pH Sensor Output Display 22 Water Test Button 24 Up Arrow Button 26 Down Arrow Button 28 Alarm Speaker 30 Alarm Light 32 Faceplate 33 Receive and Display Assembly (RDA) 34 Ring Magnet 36 Infrared Emitter 38 Infrared Detector 39 Infrared Emitter-Detector Pair 40 Electrical Socket Connector 42 Transmitter Circuit Board 44 Threaded Standoff 45 Transmitter Circuit Assembly 46 Potting Material 48 9 Volt Battery 50 Elastomer Battery Seal 52 Elastomer Washer 54 Thumbscrew 56 Elastomer Sensor Connection Seal 58 Electrical Pin Connector 60 Receiver Circuit Board 74 STA Waterproof Boundary 76 RDA Waterproof Boundary 100 Infrared Detector Power Supply 102 Electronic Switch Power Supply 104 Electronic Switch 106 Electronic Switch Input Voltage Level 108 pH Measurement Circuitry Power Supply 110 Manual pH Measurement Request 112 Central Processing Unit (CPU) 114 Single Voltage Pulse 116 Single Infrared Light Pulse 118 Automatic pH Measurement Request 120 Electronic Memory 122 Electronic Timer 124 Timer Output 126 Amplifier Circuit 128 pH Sensor Output 130 Amplifier Circuit Output 132 Floating Reference Circuit 134 Voltage Controlled Oscillator Circuit (VCO) 136 pH Modulated VCO Input Voltage 138 Train of Frequency Modulated Voltage Pulses 140 Train of Frequency Modulated Infrared Light Pulses 142 pH Modulated Frequency Signal 144 Digital pH Value 146 Increment Set-Point Signal 148 Decrement Set-Point Signal 150 Audible Alarm CPU Output 152 Visible Alarm CPU Output DETAILED DESCRIPTION FIGS. 1 Through 5 -Preferred Embodiment [0092] The detailed description set forth in connection with the appended drawings is intended as a description of presently preferred embodiments of the invention and is not intended to represent the only forms in which the present invention may be constructed and/or utilized. The description sets forth the functions and the sequence of steps for constructing and operating the invention in connection with the illustrated embodiments. However, it is understood that the same or equivalent functions and sequences may be accomplished by different embodiments that are also intended to be encompassed within the scope of the invention. [0093] A preferred embodiment of the wireless electronic monitor for a container such as an aquarium is illustrated in FIG. 1 (exploded view). The monitor is comprised of a sense and transmit assembly (STA) 15 and a receive and display assembly (RDA) 33 . The STA 15 is configured with a pH sensor 6 that is well known as a combination electrode of the type available from Omega Engineering Inc. of Stamford, Conn. However, any other device that exhibits a variable electrical output dependent upon aqueous ionic activity, dissolved gas concentration, or temperature and the like can be used as a transducer for the STA 15 . [0094] A molded header 8 is cast around the electrical connection end of the pH sensor 6 from a two-part polyurethane or epoxy resin that cures at approximately room temperature. The resin cannot be cured at elevated temperatures or generate significant exothermic heat during the cure because the pH sensor 6 contains air and aqueous solutions that can expand or boil. The header 8 is a watertight electrical and mechanical connection of the sensor 6 to power and signal processing circuits within a transmitter housing 10 . In the preferred embodiment, the pH sensor 6 is detachable from the STA 15 so it can be easily replaced if broken or at the end of its operational life. The transmitter housing 10 and a battery cover 12 are both injection molded from a thermoplastic resin such as acrylonitrile butadiene styrene (ABS), polypropylene or the like. A transparent window 14 allows the transmission of light through an opening in the transmitter housing 10 . The STA 15 is oriented to place the transparent window 14 against the interior side of a transparent wall 16 . A similar opening (not shown) in a receiver housing 18 is aligned line-of-sight with the opening in the transmitter housing 10 . The alignment of the two openings and the location of the wireless monitor on the tank wall 16 is maintained using magnetic clamping force on the wall between the STA 15 and the RDA 33 . [0095] As shown in FIG. 1 , the preferred embodiment of the RDA 33 is configured with a pH sensor output display 20 . A water test button 22 prolongs battery life by providing an on-demand measurement and display of pH. An up arrow button 24 and a down arrow button 26 permit set-point adjustments for the desired range of pH. If pH levels are outside of that range, an alarm speaker 28 and an alarm light 30 are activated. The RDA 33 is sealed from potential water spills during aquarium maintenance by a faceplate 32 . The receiver housing 18 and the faceplate 32 of the preferred embodiment are molded from similar thermoplastic materials used for the transmitter housing 10 and the battery cover 12 . [0096] FIGS. 2 a to 2 c show the various components attached to the transmitter housing 10 . As shown in FIG. 2 a (exploded isometric view), the transparent window 14 is placed over the opening in the housing 10 and sealed watertight with silicone adhesive (not shown) or the like. A ring magnet 34 made of neodymium or similar high magnetic strength material of the type available from Master Magnetics, Inc. of Castle Rock, Colo. is placed on the window 14 and is mechanically attached to the housing 10 with epoxy adhesive (not shown) or the like. The housing 10 has a molded feature that assists aligning the window 14 and the magnet 34 with the opening in the housing 10 . A transmitter circuit assembly 45 is attached to the magnet 34 with epoxy adhesive or the like. The transmitter housing 10 is then laid on a horizontal surface and filled with a potting material 46 such as polyurethane or silicone rubber to seal the transmitter circuit assembly 45 . [0097] As illustrated in FIG. 2 b (isometric view), the transmitter circuit assembly 45 is partly comprised of an infrared emitter-detector pair 39 , an electrical socket connector 40 , and a transmitter circuit board 42 . The transmitter circuit assembly 45 is configured to place the emitter-detector pair 39 within the center opening of the ring magnet 34 so that light can be emitted or detected through the transparent window 14 . An infrared emitter 36 , an infrared detector 38 , and the socket connector 40 are well known electronic components of the type available from Digi-Key Corporation of Thief River Falls, Minn. Other electronic components comprising the transmitter circuit assembly 45 are not shown for clarity. A transmitter circuit board 42 is drilled with holes to create locations to insert a threaded stand-off 44 made of stainless steel or aluminum. As shown in FIG. 2 c , the potting material 46 fills the transmitter housing 10 cavity to just below the openings in the stand-off 44 and the socket connector 40 . [0098] Referring to FIG. 2 a , a rectangular recess is cast into the potting 46 by using a block of compliant material such as silicone rubber (not shown) to form the recess when the liquid potting 46 is dispensed or poured into the transmitter housing 10 . After the potting material 46 hardens, the rubber block is removed, and a 9 volt battery 48 is placed in the recess and connected to the transmitter assembly 45 using a well known 9 volt battery connector (not shown). The battery 48 is kept dry using an elastomer battery seal 50 and an elastomer washer 52 molded from silicone rubber or the like. By hand tightening a plastic thumbscrew 54 into the threaded stand-off 44 at each end of the battery cover 12 , the battery 48 is kept dry. The plastic thumbscrew 54 is designed to preferentially fail if over-tightened into the metal threaded stand-off 44 . [0099] FIGS. 3 a (exploded isometric view) and 3 b (isometric view) show the connection of the pH sensor 6 with the molded header 8 to the assembly shown in FIG. 2 c . Referring to FIG. 3 a , an elastomer sensor connection seal 56 is molded from silicone rubber or the like to seal the gap between the molded header 8 and the hardened potting material 46 . An electrical pin connector 58 is partially encapsulated in the molded header 8 and inserted into the socket connector 40 openings (shown in FIG. 2 c ). By tightening a third thumbscrew 54 into a third threaded standoff 44 (shown in FIG. 2 c ), the seal 56 is compressed into the surface of the cured potting material 46 . Another washer 52 maintains a waterproof seal of the socket connector 40 and the pin connector 58 . FIG. 3 b shows the fully assembled and sealed STA 15 ready to submerge in water. [0100] As shown in FIG. 4 (exploded isometric view), the RDA 33 also contains the transparent window 14 and the ring magnet 34 . Both are attached to a feature molded into the receiver housing 18 in a manner similar to the method used for the transmitter housing 10 . A receiver circuit board 60 is configured with the emitter-detector pair 39 (not shown) and is mechanically attached to the ring magnet 34 with epoxy or similar adhesive. Other electronic components on the receiver circuit board 60 and the battery power supply for the RDA 33 are not shown for clarity. [0101] Additionally, the preferred embodiment integrates the water test button 22 , the up arrow button 24 , and the down arrow button 26 into a well known membrane switch (not shown) of the type available from Nelson Nameplate of Los Angeles, Calif. The membrane switch is fabricated from laminated sheets of polyester or polycarbonate, to which conductive and colored inks are applied. Switches, light emitting diodes, regions of transparency for viewing underlying displays, and artwork can be combined into a very flat structure that is rugged and has low fabrication costs. The membrane switch is attached to the faceplate 32 typically using tape backed with acrylic adhesive or the like to provide a sealed keypad that is waterproof. Electrical contact of such a membrane switch to an electrical connection on the receiver circuit board 60 is typically done with a pigtail formed in the laminated sheets (not shown). [0102] A schematic representation of the wireless monitor of pH for an aquarium is illustrated in FIG. 5 . Clearly shown is the demarcation of the two main assemblies, with the STA 15 on the internal water side of the tank wall 16 , and the RDA 33 on the external air side. An STA waterproof boundary 74 is formed around the electronics contained within the STA 15 , leaving the water sensing end of the pH sensor 6 exposed to the water. Similarly, an RDA waterproof boundary 76 is formed around the electronics contained within the RDA 33 . [0103] FIG. 5 shows that the battery 48 provides an infrared detector power supply 100 to the infrared detector 38 contained in the STA 15 . The battery 48 also provides an electronic switch power supply 102 to an electronic switch 104 . When the infrared detector 38 is not illuminated above a set light threshold level, an electronic switch input voltage level 106 is configured to keep the switch 104 open. The open switch 104 prevents consumption of a pH measurement circuitry power supply 108 during periods of time when a pH measurement is not desired. [0104] When a pH measurement is desired, FIG. 5 shows two methods by which it may be requested. Using the RDA 33 , a manual pH measurement request 110 can be sent to a central processing unit (CPU) 112 by pressing the water test button 22 . The CPU 112 sends a single voltage pulse 114 to the infrared emitter 36 within the RDA 33 , causing it to emit a single infrared light pulse 116 . An automatic pH measurement request 118 uses stored times or time periods accessed from an electronic memory 120 by the CPU 112 to initiate the single light pulse 116 . [0105] The single pulse of infrared light 116 transmits through the transparent window 14 in the RDA 33 , through the transparent wall 16 , through the transparent window 14 in the STM 15 , and illuminates the infrared detector 38 within the STA 15 . During the period that the detector 38 is illuminated by the light pulse 116 , the switch input voltage level 106 is configured to close the open switch 104 . [0106] For the duration of the light pulse 116 , the pH measurement circuitry power supply 108 is connected to an electronic timer 122 that self-starts immediately. A timer output 124 is connected to the switch input voltage level 106 to hold the switch 104 closed after the duration of the single light pulse 116 has elapsed, and will remain closed for the duration that the timer 122 is on. While the electronic timer 122 is on, the pH measurement power supply 108 is connected to the timer 122 . When the timer 122 reaches the end of the specified on period, the timer output 124 is configured to open the switch 104 and eliminate its own power supply 108 . The timer 122 will not re-start until the single infrared light pulse 116 requests another pH measurement. [0107] During the period that the timer 122 is on, the pH measurement circuitry power supply 108 is turned on to the rest of the circuitry on the transmitter circuit assembly 45 (shown in FIG. 2 b ). In the preferred embodiment, an amplifier circuit 126 and the pH sensor 6 of FIG. 5 are placed close together and encapsulated in the molded header 8 (shown in FIGS. 3 a and 3 b ). An amplifier circuit output 130 shown in FIG. 5 is connected to the transmitter circuit assembly 45 by the socket connector 40 (shown in FIGS. 2 a to 2 c ), and the pin connector 58 (shown in FIG. 3 a ). [0108] Referring again to FIG. 5 , a floating reference circuit 132 places the reference potential for the pH sensor 6 and the amplifier circuit 126 at approximately 3 volts, or about one third of the 9 volt battery 48 potential. This is required because the pH sensor can be a positive or negative voltage. The gain of the amplifier 126 is configured so that negative voltage levels at the amplifier output 130 do not go more than about 2 volts below the reference potential for all expected values of pH to be measured. A voltage controlled oscillator circuit (VCO) 134 receives a pH modulated VCO input voltage 136 that will always be positive and indicative of the pH sensor output 128 . By placing the reference potential at approximately 3 volts and limiting the amplifier output 130 to about plus or minus 2 volts relative to that reference, the battery 48 can be used when depleted to as low as 5 volts. [0109] The VCO 134 converts the pH dependent VCO input voltage 136 into a train of frequency modulated voltage pulses 138 . The voltage pulses 138 drive the infrared emitter 36 in the STA 15 to emit a train of frequency modulated light pulses 140 . The light pulses 140 are transmitted through the transparent window 14 in the STA 15 , the transparent tank wall 16 , and the transparent window 14 in the RDA 33 . The infrared detector 38 in the RDA 33 is illuminated by the train of light pulses 140 and generates a pH modulated frequency signal 142 that is sent to the CPU 112 . The frequency of the signal 142 is compared with a calibration look-up table in the electronic memory 120 that is obtained by measuring the frequency of the pH modulated signal 142 when the pH sensor 6 is immersed into a standard solution of known pH for two or more pH values. A digital pH value 144 of the current pH within the tank is sent to the pH sensor output display 20 and provides a visible numeric pH value. [0110] By using the up arrow button 24 and the down arrow button 26 to adjust upper and lower bounds for acceptable pH, set-point values are stored in the electronic memory 120 . The ability to send an increment set-point signal 146 or a decrement set-point signal 148 to the CPU 112 permits adjustable alarm levels for aquarium pH. The CPU 112 is programmed to periodically make an automatic pH measurement request 118 and initiate a pH measurement in the manner shown in FIG. 5 . The pH modulated frequency signal 142 obtained from the periodic measurement is evaluated by the CPU 112 programming to ascertain whether the pH of the water contained in the tank is outside of two limit values stored in electronic memory 120 . If the pH is outside of the pre-defined limits, an audible alarm CPU output 150 will activate the alarm speaker 28 . A versatile alarm system includes a visible alarm CPU output 152 to activate the alarm light 30 when an aquarium owned by a hearing impaired person requires attention. Operation—FIGS. 1, 2 , and 5 [0111] The manner of using the wireless monitor is to immerse the STA 15 into the aquarium water and place the side with the transparent window 14 against the transparent wall 16 of the tank. Holding the STA 15 against the interior surface of the wall 16 with one hand, the transparent window 14 in the RDA 33 is placed against the exterior surface of the wall 16 using the other hand. Sliding the RDA 33 or the STA 15 against their respective surfaces of the wall 16 , the two windows 14 are brought into approximate line-of-sight alignment until the magnet 34 in each attract one another. When the magnetic attraction between the STA 15 and the RDA 33 is sufficient to hold them in place on the tank wall 16 , they are released and rely on friction to maintain their position. When the wall 16 is sandwiched between the STA 15 and the RDA 33 , the position of this invention can be adjusted as desired by grasping the RDA 33 and sliding it on the exterior surface of the wall 16 . Held in place by magnetic attraction, the STA 15 will slide along the interior surface of the tank wall 16 and follow the movement to the desired wall 16 location for the wireless monitor. This makes it a simple process to sandwich the wall 16 with the STA 15 and the RDA 33 near the surface of the water and move it to a deeper location on the transparent wall 16 . [0112] To make a pH measurement, the water test button 22 is manually pushed. The RDA 33 will send a single light pulse 116 to the STA 15 that will activate the timer 122 and turn the pH measurement circuit power supply 108 on for a pre-determined amount of time. For that period of time, a train of frequency modulated infrared light pulses 140 are transmitted from the STA 15 to the RDA 33 . The CPU 112 will sample the pH modulated frequency signal 142 for the time required to obtain an accurate average of its frequency. That frequency is converted to a digital pH value 144 that is then shown in the monitor display 20 as a numerical value of pH for a pre-determined amount of time. [0113] To calibrate the pH sensor 6 or to adjust alarm set-points, there are numerous ways to indicate to the CPU 112 that such an action is desired. Simultaneously pressing the up arrow button 24 and the down arrow button 26 , or the addition of specific buttons to the faceplate 32 are only two ways that can be employed. The specific mechanism by which the look-up table in electronic memory 120 that contains calibration constants and set-point pH values is updated is beyond the scope of the present invention. Because this invention is clearly described as dependent upon the CPU 112 and the electronic memory 120 , the reader can see that the specificities of software programming are not necessary to provide full disclosure. Additional Embodiments [0114] There are a number of water parameters that can be sensed using a probe similar to the pH sensor of this invention. Ions that are of interest to aquarium owners are reflected in the commercial availability of colorimetry kits that test for ammonia, nitrate, nitrite, hardness and alkalinity. All of the ions measured by the colorimetry kit can be measured by similar electrodes used to measure pH, and thus can be directly used by the wireless monitor. Dissolved oxygen sensors, conductivity cells for salinity, and temperature sensors such as a thermistor are also readily adapted to the wireless monitor for aquariums. [0115] The preferred embodiment of this invention describes a single sensor, specifically for measuring pH. In practice, this invention can be embodied with multiple sensors. A second device such as a temperature sensor can easily be attached to the described transmitter circuit assembly and provide monitoring of yet another important water parameter for aquariums and the like. [0116] The wireless monitor can be configured with a sensor for a fluid such as a gas, enabling this invention to be used to measure moisture, flammable or explosive gas levels, and oxygen in a closed container such as a glove-box. [0117] Configured with a radiation sensor, this invention can be used for radioactive applications where the wireless monitor can be placed on a glove-box viewing window or the leaded glass of a radioactive waste storage chamber. [0118] This invention as described is used on an aquarium having a transparent wall of glass, acrylic or the like. In the case of an opaque tank made of a material such as fiber-filled polypropylene or polyethylene, the infrared light used to convey the sensor information would not transmit through the wall. In such a case, this invention would be useful using another form of energy to transmit the pulses that initiate of a pH measurement and subsequent pH sensor output. Such forms of energy include, but are not limited to: 1. a fluctuating magnetic field for a tank wall material that does not form a Guassian shield, such as a fiber-filled thermoplastic or thermoset polymer, copper, and some stainless steels; 2. radio or microwave frequency radiation for a non-metallic tank wall where the conductivity of the liquid within does not significantly affect the signal strength; and 3. acoustic energy to transmit the sensor output through tank walls made of a material that interposes a Gaussian shield between the STA and the RDA. [0122] The method by which this invention can be attached to the tank wall and maintain the location in which it was placed is shown to be the mutual attraction of two magnets in the preferred embodiment. This method works best when the wall thickness is less than approximately one half inch. For a wall that is significantly thicker, this invention is useful if the STA and the RDA are attached directly to the wall using a suction cup or similar device. In applications where there are large fish that could knock the STA off from the interior wall or other turbulent scenarios, it can be attached directly to the tank wall using an adhesive such as silicone or epoxy. When using the monitor in public places, permanent attachment of the RDA to the exterior wall of the tank may be required to prevent theft. [0123] The present invention can be used on a container such as a bag made of polyethylene, polyethylene terephthalate (PET), or similar material. [0124] The encapsulation with the potting material of the transmitter circuit assembly can be obviated using housing structures that incorporate rubber seals and the like. [0125] The frequency modulated voltage pulses and subsequent frequency modulated light pulses can be configured in pattern conforming to a standard serial communication format such as RS-232 or similar. [0126] The detachable sensor shown in the preferred embodiment can be incorporated directly into the STA if the operational life is considered permanent, such as a thermocouple, thermistor, or conductivity cell and the like. [0127] This invention finds great usefulness when configured with access to the Internet or a wireless cellular phone network to send the measurement results of many tanks to a central monitoring location. [0128] By storing the measurement results in electronic memory for later retrieval, this invention is useful in applications such as shipment of live aquatic specimens and other records of water fitness over time. [0129] This invention can be configured in many shapes other than rectangular, including but not limited to circular, square, triangular, or an iconic shape such as an aquatic life form, logo or decorative representation. Advantages [0130] From the description above, a number of advantages of this wireless electronic monitor for containers such as aquariums become evident: 1. An aquarium can be monitored around the clock for pH. 2. This invention generates an audible and visible alert if the pH of the water is outside of expected boundaries. 3. This invention is easy to install on the wall of a tank near the surface the water and can be moved to a deeper location without inserting the hand or arm into the water. 4. A pH dependent electrical signal gives the opportunity to use a CPU to manage sensor calibration, activate alarms, and store measurement results. 5. The wireless electronic monitor has a broader test range and finer resolution of measurement than colorimetry pH measurements. 6. This invention is simple to use and less intrusive for aquarium applications than laboratory and industrial pH monitoring equipment presently available. 7. Sandwiching the wall of a container such as a tank or aquarium permits this invention to operate in saltwater because the transmission medium is the wall material, not the liquid contained in the tank. CONCLUSIONS, RAMIFICATIONS, AND SCOPE [0138] Accordingly, the reader will see that the wireless electronic monitor can be configured with a sensor other than for pH, can use two or more sensors together such as pH and temperature, and can be configured with a sensor for gases, vapors or radioactivity. Also, this invention can use forms of energy other than light to communicate sensor output, can also be attached to a container wall with suction generating devices or adhesive, can be configured with access to distributed communications-networks to monitor multiple tanks from a remote location, and can be configured to store periodic measurement results in the electronic memory to serve as a data logger. Additional embodiments use modulated light pulses that conform to a serial communication standard, integrate the sensor into the sense and transmit assembly (STA), and can have various shapes. [0139] Although the description above contains many specificities, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments of this invention. While the invention has been described in connection with certain preferred embodiments, it is not intended to limit the scope of the invention to the particular forms set forth, but on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be included within the scope of the invention as defined by the claims.

A wireless electronic monitor for a container such as an aquarium is described. The apparatus comprises a sense and transmit assembly (STA) 15 configured with a pH sensor 6 submerged in the water inside the aquarium, and a receive and display assembly (RDA) 33 that displays the output of the sensor 6 . A line-of-sight orientation is maintained between openings in each assembly using magnets to generate a clamping force on a transparent tank wall 16 . A water test button 22 is pressed, and a single pulse of light travels from the RDA 33 to the STA 15 . The single pulse of light turns the STA 15 on by closing a timed switch to the battery power. The pH sensor 6 output is converted to a train of frequency-modulated pulses of light that are transmitted back to the RDA 33 . The frequency of the train of light pulses is determined by a CPU in the RDA 33 , and assigned a pH value from calibration tables stored in electronic memory. The pH value is shown on a pH sensor output display 20 which can be manually placed anywhere on the tank wall by grasping the RDA 33 from the outside of the aquarium, and sliding the entire monitor to its desired location without getting wet hands. To fully realize a true monitor of the pH, the CPU in the RDA 33 is programmed to make periodic measurements of the pH by periodically emitting the single pulse of light to the STA 15 . The results of each measurement are compared with upper and lower pH boundaries stored in an electronic memory. If a measurement is outside of a pre-determined range, the CPU activates an alarm speaker 28 and an alarm light 30.

This invention relates to sporting equipment, particularly to a soccer training device comprising a portable pedestal and a soccer ball, linked by a spring which permits displacement of the ball, and returns the ball to its initial position. BACKGROUND OF THE INVENTION At present, there exist various devices for training and practice of soccer (association football) which in general terms can be described as comprising a soccer ball set up by means of an anchor to a floor. The connection between the anchor and the soccer ball is achieved in various ways. One of the ways in which the connection is achieved is by linking the soccer ball to the anchor by means of an elastic cord. A device which uses an elastic cord presents multiple problems, since it requires the use of a very large area, which restricts the number of locations for use, besides the fact that the long elastic cord can become an obstacle which may trip the user. Also, using an elastic cord causes a fixed and slow time of return, which does not adequately train the user for the real game of soccer, particularly dribbling. Other known soccer training devices involve an elastic panel or barrier placed vertically, against which the user kicks the ball. This barrier device also requires a very large area, which restricts the number of locations where it can be used. Another known training device includes a bag, which contains a soccer ball, mounted flexibly on a spring-board, which constitutes the playing surface on which the user kicks the bag containing the ball. This spring-board device can be used in small areas, but it presents the disadvantage that the hook-up or fastening which attaches the bag to the soccer ball presents difficulties. Another known training device consists of a bag containing a soccer ball, fixed on an anchor to the floor by means of an elastic element. Manufacturing this bag becomes considerably onerous economically, and it is even anticipated that the bag may be replaced by a series of restraining straps, which will undoubtedly not provide great stability for the soccer ball when it is kicked. SUMMARY OF THE INVENTION The invention is directed to a soccer training device which comprises a transportable pedestal to which a soccer ball is fixed directly by means of an elastic element. The pedestal, which is shaped like a hollow truncated cone, may be very heavy or have available sufficient interior space to be filled with the necessary ballast. The soccer ball, which can be kicked and returns immediately to its original position, is affixed by means of a spring element to the above-mentioned pedestal, which is easily transportable and occupies a small space. BRIEF DESCRIPTION OF THE DRAWINGS In the accompanying drawings, FIG. 1 is a perspective view of a soccer training device embodying the invention. FIG. 2 is a side elevation, in partial section, of the device shown in FIG. 1. DESCRIPTION OF THE PREFERRED EMBODIMENT A soccer training device embodying the invention comprises a soccer ball 1 and a transportable pedestal 2. The pedestal 2 and the soccer ball 1 are linked by a coil spring 3, which is preferably tapered at both ends, as shown. The joint between the coil spring 3 and the soccer ball 1 is achieved by the installation of a stem 4 which penetrates into the ball 1 and is fixed on the inside of the ball by one nut, and on the outside of the ball by another nut 5, while the other end of the stem 4 is affixed inside the upper end of the coil spring 3. The coil spring 3 surrounds another protruding stem 6 in its lower end, this stem being fixed to a central seat 9 in the circular base 10 of the pedestal 2, by means of a washer 7 and two nuts 8. The pedestal is made as a hollow body whose exterior is shaped as a truncated cone 11 having a concave profile. The upper surface of the pedestal has, at its center, a recess whose surface 12 also has a truncated conical shape, but with an upwardly convex profile. The bottom of the base has a seat 9 where a lock washer 7 is affixed together with nuts 8 and the stem 6 of the lower end of the coil spring 3. The pedestal 2 has on its external surface 11 an indentation 13 which works as a handle for transporting the entire device. The pedestal 2 may itself have a weight which permits kicking the ball without moving the pedestal at all, or it may also have in its interior sufficient space to contain ballast which permits fixing the device as a whole in one place, so that it cannot move when the soccer ball 1 is kicked. With this structure, the player will be able to kick continuously (dribble) the soccer ball 1, which because of its elastic attachment through the coil spring 3, will tend to strike the concave surface 11 of the pedestal, then rebound and return to its initial position. With this device, great simplicity is achieved in practice and training, the disadvantages of anchoring to the floor and the use of large areas are also eliminated, and also the device can be transported very easily from one place to another. Inasmuch as the invention is subject to modifications and variations, it is intended that the foregoing description and the accompanying drawings shall be interpreted as illustrative of only one form of the invention, whose scope is to be measured by the following claims.

A soccer training device includes a transportable pedestal and a soccer ball connected to the pedestal by a coil spring. The device may be used to practice dribbling.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 11/238,204, filed on Sep. 29, 2005 and issued on Aug. 17, 2010 as U.S. Pat. No. 7,776,035, which claims the benefit of and priority to U.S. Provisional Application No. 60/617,337, filed on Oct. 8, 2004, the entire contents of each of which are incorporated herein by reference. BACKGROUND 1. Technical Field The present disclosure relates generally to cluster ablation electrode systems and, more particularly, to systems, devices and methods for positioning and placing multiple electrodes in a target surgical site. 2. Background of Related Art The use of radiofrequency electrodes for ablation of tissue in a patient's body is known. In a typical situation, a radiofrequency electrode comprising an elongated, cylindrical shaft with a portion of its external surface insulated is inserted into the patient's body. The electrode typically has an exposed conductive tip, which is used to contact body tissue in the region where the heat lesion or ablation is desired. The electrode is connected to a radiofrequency power source, which provides radiofrequency voltage to the electrode, which transmits the radiofrequency current into the tissue near its exposed conductive tip. This current usually returns to the power source through a reference electrode, which may comprise a large area conductive contact connected to an external portion of the patient's body. In some applications, for example, tumor ablation procedures, multiple electrodes are inserted into the body in an array to enlarge ablation volumes. In a particular application, arrays of high frequency electrodes are inserted into tumors. The electrodes are typically placed in a dispersed fashion throughout the tumor volume to cover the tumor volume with uniform heat, typically below about 45° C. The electrodes may be sequentially applied with high frequency voltage so that each electrode heats in sequence its neighboring tissue and then shuts off. Then, the next electrode does the same in a time series. This sequence of cycling the voltage through the electrodes continues at a prescribed frequency and for a period of time. The electrode systems discussed above are limited by the practical size of lesion volumes they produce. Accordingly, electrodes with cooled conductive tips have been proposed. With cooling, radiofrequency electrode tips generally produce larger lesion volumes compared with radiofrequency electrodes, which are not cooled. For example, standard single cylindrical electrodes, with cooled tips, as described above, may make lesion volumes up to 3 to 4 cm in diameter in living tissue (e.g., the liver) by using cannulae of 1 to 2 mm in diameter and having exposed tip lengths of several centimeters. Desirably, a configuration of radiofrequency electrodes, which can accomplish ablation in the range of 4 to 6 cm diameter or greater for the purpose of adequately treating large cancerous tumors in the body are necessary to effectively destroy the tumor and combat cancerous cells from spreading. It is further necessary that such an electrode system involve a simple geometry, reduced numbers of tissue insertions, facilitate planning of needle placement, and facilitate planning of heat ablation geometry and distribution. An electrode system, which can be easily inserted into an organ or through the skin with minimal risk of hemorrhage and discomfort to the patient, is desirable. According to yet another aspect of the present disclosure, an introducer is provided for facilitating the insertion of a cluster of electrodes into the body of a patient for tissue for performing tissue ablation. The introducer includes a body portion including a plurality of holes formed therein for selectively receiving a respective elongated shaft of the electrodes therethrough, wherein the holes of the introducer orient and space each electrode relative to one another, wherein the introducer includes a centrally disposed hole formed therein for receiving a guide needle therethrough. The introducer may further include a distal introducer including a plurality of arrays of hole clusters formed therein each arranged in a linear row, wherein the rows of hole clusters are equally spaced from one another; and a proximal introducer including a plurality of arrays of holes formed therein each arranged in a linear row, wherein the rows of holes are equally spaced from one another. The holes of each radial row of holes of the proximal introducer may be equally spaced from one another. In an embodiment, the proximal introducer includes six arrays of holes formed, wherein the rows of holes of the proximal introducer alternate between rows of six holes and rows of seven holes. Each cluster of holes of the distal introducer may include a radially inner-most hole and a pair of radially outer-most holes. The radially outer-most holes may be offset an angle from an axis extending through the inner-most holes of each respective array of hole clusters. The inner-most holes of each radial row of clusters of the distal introducer may be equally spaced from one another. The distal introducer may include six arrays of clusters formed therein arranged in a linear row. The rows of clusters of the distal introducer may alternate between rows of six clusters and rows of seven clusters. Systems or devices which facilitate the positioning and placement of the radiofrequency electrodes relative to one another and relative to the target tissue volume are also desirable. SUMMARY The present disclosure relates to systems, devices and methods for positioning and placing multiple electrodes in a target surgical site. According to an aspect of the present disclosure an electrode system is provided for use with a high frequency generator to induce coherent high frequency heat ablation volumes within targeted tissue of a patient. The electrode system includes a hub and at least three electrodes. Each electrode includes a substantially rigid elongated shaft extending from the hub and terminating in a sealed distal end section having an exposed conductive tip portion configured to be inserted into the targeted tissue and adapted at a proximal end section to be coupled to a high frequency generator to simultaneously apply an equal output voltage to each of the exposed conductive tip portions. Each electrode further includes a closed-loop fluid communication channel pathway which includes an inflow opening adapted for connection to a coolant fluid supply, and a channel portion in fluid communication with the inflow opening. The channel portion extends distally inside the conductive tip portion to carry coolant to the inside of the conductive tip portion and further extends proximally back to an outlet opening adapted to carry coolant away from the conductive tip portion. The electrode system further includes an introducer including a plurality of holes formed therein for selectively receiving a respective elongate shaft of the electrodes therethrough. The holes of the introducer orient and space each electrode relative to one another. The introducer includes a centrally disposed hole formed therein for receiving a guide needle therethrough. The conductive tip portions of the at least three electrodes may be arrayed relative to each other in a predetermined non-linear geometric spatial relationship relative to a longitudinal axis of the instrument such that upon application of an output voltage to the conductive tip portions, a coherent ablation isotherm is generated which encloses a desired target volume of the tissue to induce a large heat ablation volume. In an embodiment, the electrode receiving holes of the introducer are each equally spaced from the central hole of the introducer. Each electrode receiving hole of the introducer includes a longitudinal axis which is parallel to one another. In an embodiment, the electrode system includes a distal introducer and a proximal introducer. The distal introducer and the proximal introducer may each include a central hole formed therein for selectively receiving a guide needle therethrough, wherein the central holes function to align the distal and proximal introducers with one another. The proximal introducer may include a plurality of arrays of holes formed therein each arranged in a linear row. The rows of holes are desirably equally spaced from one another. It is envisioned that the holes of each radial row of holes of the proximal introducer are equally spaced from one another. The proximal introducer includes six arrays of holes formed therein arranged in a linear row. In an embodiment, the rows of holes of the proximal introducer alternate between rows of six holes and rows of seven holes. It is contemplated that the distal introducer includes a plurality of arrays of hole clusters formed therein each arranged in a linear row. The rows of hole clusters are desirably equally spaced from one another. Each cluster of holes of the distal introducer may include a radially inner-most hole and a pair of radially outer-most holes. The radially outer-most holes may be offset an angle from an axis extending through the inner-most holes of each respective array of hole clusters. In an embodiment, the inner-most holes of each radial row of clusters of the distal introducer are equally spaced from one another. The distal introducer includes six arrays of clusters formed therein arranged in a linear row. The rows of clusters of the distal introducer alternate between rows of six clusters and rows of seven clusters. According to another aspect of the present disclosure, a system for inducing enlargement of heat ablation volumes within tissue of a patient's body is provided. The system includes a high frequency generator for supplying an output voltage; at least three substantially rigid, elongated electrodes adapted to be inserted into the tissue of a patient's body; and an introducer including a plurality of holes formed therein for selectively receiving a respective elongate shaft of the electrodes therethrough. Each of the at least three electrodes has exposed conductive tip portions arranged in a predetermined parallel relationship and a closed-loop fluid communication channel pathway. The channel pathway includes an inflow opening adapted for connection to a coolant fluid supply, and a channel portion in fluid communication with the inflow opening. The channel portion extends distally inside the conductive tip portion to carry coolant to the inside of the conductive tip portion and further extends proximally back to an outlet opening adapted to carry coolant away from the conductive tip portion. The holes of the introducer orient and space each electrode relative to one another. The introducer includes a centrally disposed hole formed therein for receiving a guide needle therethrough. The introducer includes a distal introducer including a plurality of arrays of hole clusters formed therein each arranged in a linear row, wherein the rows of hole clusters are equally spaced from one another; and a proximal introducer including a plurality of arrays of holes formed therein each arranged in a linear row, wherein the rows of holes are equally spaced from one another. The holes of each radial row of holes of the proximal introducer may be equally spaced from one another. The proximal introducer may include six arrays of holes formed. The rows of holes of the proximal introducer alternate between rows of six holes and rows of seven holes. Each cluster of holes of the distal introducer may include a radially inner-most hole and a pair of radially outer-most holes, wherein the radially outer-most holes may be offset an angle from an axis extending through the inner-most holes of each respective array of hole clusters. The inner-most holes of each radial row of clusters of the distal introducer may be equally spaced from one another. The distal introducer may include six arrays of clusters formed therein arranged in a linear row. The rows of clusters of the distal introducer may alternate between rows of six clusters and rows of seven clusters. According to yet another aspect of the present disclosure, a process for heat ablation of tissue in a patient is provided. The process includes the steps of providing an electrode system for inducing enlargement of heat ablation volumes within tissue of a patient's body. The electrode system includes a high frequency generator for supplying an output voltage; at least three substantially rigid, elongated electrodes adapted to be inserted into the tissue of a patient's body; and an introducer including a plurality of holes formed therein for selectively receiving a respective elongate shaft of the electrodes therethrough. Each of the at least three electrodes has an exposed conductive tip portion arranged in a predetermined parallel relationship and a closed-loop fluid communication channel pathway. The channel pathway includes an inflow opening adapted for connection to a coolant fluid supply, and a channel portion in fluid communication with the inflow opening. The channel portion extends distally inside the conductive tip portion to carry coolant to the inside of the conductive tip portion and further extends proximally back to an outlet opening adapted to carry coolant away from the conductive tip portion. The holes of the introducer orient and space each electrode relative to one another. The introducer includes a centrally disposed hole formed therein for receiving a guide needle therethrough. The method further includes inserting the electrodes into desired holes of the introducer in order to position each electrode relative to one another; inserting the electrodes into the tissue; applying substantially the same radiofrequency output through the electrodes to a targeted tissue volume to produce coherent heating of the targeted tissue volume; raising the radiofrequency output to a level that induces enlargement of the volume of heat ablation in the tissue near the electrodes; and cooling each electrode by circulating a cooling fluid through a closed-loop fluid communication channel pathway formed in each of the electrodes. It is envisioned that the introducer includes a distal introducer including a plurality of arrays of hole clusters formed therein each arranged in a linear row, wherein the rows of hole clusters are equally spaced from one another; and a proximal introducer including a plurality of arrays of holes formed therein each arranged in a linear row, wherein the rows of holes are equally spaced from one another. The method further includes the steps of placing the electrodes into desired holes of the proximal introducer; placing the distal introducer in a desired position on the skin surface of the patient; introducing the electrodes into the patient through the holes provided in the distal introducer; and advancing the electrodes through the distal introducer. The method may further include the steps of placing a guide needle into a central hole formed in the distal introducer; inserting the guide needle into the body of the patient such that a tip of the guide needle is placed in close proximity to a target tissue; and placing the distal introducer against the skin of the patient. The method may further include the steps of withdrawing the guide needle from the distal introducer; and inserting the electrodes into the body of the patient through the holes formed in the distal introducer. The method may still further include the step of advancing the electrodes through the distal introducer until the tips thereof are in close proximity to the target tissue. For a better understanding of the present disclosure and to show how it may be carried into effect, reference will now be made by way of example to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS Various preferred embodiments of the presently disclosed systems, devices and methods are disclosed herein with reference to the drawings wherein: FIG. 1 is a schematic illustration of an ablation electrode array system according to the present disclosure showing multiple radiofrequency electrodes being positioned in a patient's organ for producing heat ablation of a targeted tissue area; FIG. 2 is a perspective view of an electrode introducer according to an embodiment of the present disclosure; FIG. 3 is a perspective view of the electrode introducer of FIG. 2 including a needle extending therefrom; FIG. 4 is a perspective view of the electrode array system of FIG. 1 including a two piece combined electrode introducer according to another embodiment of the present disclosure; FIG. 5 is a perspective view of a first electrode introducer of the two piece combined electrode introducer shown in FIG. 4 ; FIG. 6 is a top plan view of the first electrode introducer of FIG. 5 ; FIG. 7 is a perspective view of a second electrode introducer of the two piece combined electrode introducer shown in FIG. 4 ; FIG. 8 is a top plan view of the second electrode introducer shown in FIG. 7 ; and FIG. 9 is an enlarged view of the indicated area of detail of FIG. 8 . DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring initially to FIG. 1 , an embodiment of a multiple electrode arrangement such as an ablation electrode array system, in accordance with the present disclosure, is generally designated “E”. Electrode array system “E” includes a plurality of electrodes 1 , 2 and 3 , which are to be inserted into an organ “OR” of a human body or any other body tissue. Respective distal tips 1 b , 2 b and 3 b of electrodes 1 , 2 and 3 are un-insulated and conductively exposed so that electrical currents induce heating within the tissue or organ “OR”. A targeted volume of tissue “T” is shown in sectional view and may represent, for example, a tumor or other abnormality in a human body. Electrodes 1 , 2 and 3 are connected by respective wires or cables 10 , 11 and 12 to an electrosurgical generator 16 . Electrosurgical generator 16 may be a radiofrequency or high frequency type generator. Electrosurgical generator 16 includes control elements, illustrated by block 17 , which may, for example, increase the radiofrequency power output of electrodes 1 , 2 and 3 , control temperature when electrode array system “E” or satellite sensors (not shown) include temperature sensors, monitor or control impedance, power, current, voltage, or other output parameters. Electrosurgical generator 16 may include a display or screen, illustrated by block 18 , within it or as a separate system, for providing a display of heating parameters such as temperature for one or more of electrodes 1 , 2 and 3 , impedance, power, current, or voltage of the radiofrequency output. Such individual display readings are illustrated by the reference letters R 1 . . . RN. Electrode system “E” further includes a reference electrode 19 , which may be placed in contact with the skin of a patient or an external surface of organ “OR” with a connection 20 to electrosurgical generator 16 . Reference electrode 19 and connection 20 serves as a path for return current from electrosurgical generator 16 through electrodes 1 , 2 and 3 . Each electrode 1 , 2 and 3 includes a rigid shaft 1 a , 2 a and 3 a , respectively, which enables electrodes 1 , 2 and 3 to be easily urged into the body tissue or organ “OR”. Each electrode 1 , 2 and 3 terminates pointed distal tips 1 b , 2 b and 3 b , respectively. Desirably, a portion of the external surface of each electrode 1 , 2 and 3 is covered with an insulating material, as indicated by hatched line areas in FIG. 1 . Distal tips 1 b , 2 b and 3 b are connected, through respective shafts 1 a , 2 a and 3 a to cables 10 , 11 and 12 , respectively, and thereby to electrosurgical generator 16 . By way of example only and in no way to be considered as limiting, electrosurgical generator 16 may be a radiofrequency generator with frequency between about 100 kilohertz (kHz) to several hundred megahertz (MHz). Additionally, electrosurgical generator 16 may have power output ranging from several watts to several hundred watts, depending on the clinical application. Desirably, electrodes 1 , 2 and 3 may be raised to the same radiofrequency voltage potential from electrosurgical generator 16 . The array of electrodes thus becomes, in effect, a larger, coherent electrode including the individual electrode tips 1 b , 2 b and 3 b . Thus, the heating effect of the array of electrodes is substantially similar to that achieved by one large single electrode. As seen in FIG. 1 , by way of illustration only, a targeted region to be ablated is represented in sectional view by the line “T”. It is desired to ablate the targeted region “T” by fully engulfing targeted region “T” in a volume of lethal heat elevation. The targeted region “T” may be, for example, a tumor which has been detected by an image scanner 30 . For example, CT, MRI, or ultrasonic image scanners may be used, and the image data transferred to a computer 26 . As an alternate example, an ultrasonic scanner head 15 may be disposed in contact with organ “OR” to provide an image illustrated by lines 15 A. A data processor 16 may be connected to the display devices to visualize targeted region “T” and/or ablation zone “T 1 ” in real time during the ablation procedure. The image representation of the scan may be displayed on display unit 22 to represent the size and position of target region “T”. Placement of electrodes 1 , 2 and 3 may be predetermined based on such image data as interactively determined by real-time scanning of organ “OR”. Electrodes 1 , 2 and 3 are inserted into the tissue by freehand technique by a guide block or introducer 100 with multi-hole templates, or by stereotactic frame or frameless guidance, as known by those skilled in the art. Desirably, an array of electrodes 1 , 2 and 3 are connected to the same radiofrequency voltage from electrosurgical generator 16 . Accordingly, the array of electrodes 1 , 2 and 3 will act as a single effectively larger electrode. The relative position and orientation of electrodes 1 , 2 and 3 enable the creation of different shapes and sizes of ablation volumes. For example, in FIG. 1 , dashed line 8 represents the ablation isotherm in a sectional view through organ “OR”. Such an ablation isotherm may be that of the surface achieving possible temperatures of approximately 50° C. or greater. At that temperature range, sustained for approximately 30 seconds to approximately several minutes, tissue cells will be ablated. The shape and size of the ablation volume, as illustrated by dashed line 8 , may accordingly be controlled by the configuration of the electrode array, the geometry of the distal tips 1 b , 2 b and 3 b of electrodes 1 , 2 and 3 , respectively, the amount of RF power applied, the time duration that the power is applied, cooling of the electrodes, etc. Turning now to FIGS. 2 and 3 , a guide block or introducer, in accordance with an embodiment of the present disclosure, is generally designated as 100 . Introducer 100 includes a plurality of electrode through-holes 102 formed therein. Desirably, as seen in FIGS. 2 and 3 , introducer 100 includes a first set of three holes 102 a , 102 b and 102 c formed therein. Preferably, holes 102 a , 102 b and 102 c are spaced an equal distance apart from one another. As such, holes 102 a , 102 b and 102 c define an equilateral triangle. Each hole 102 a , 102 b and 102 c defines a longitudinal axis “Xa, Xb and Xe”. Preferably, longitudinal axes “Xa, Xb and Xc” are at least substantially parallel to one another. Desirably, holes 102 a , 102 b and 102 c are sized and dimensioned to slidably receive a respective electrode 1 , 2 and 3 therein. With continued reference to FIGS. 2 and 3 , introducer 100 further includes a central hole 104 formed therethrough. Central hole 104 defines a central longitudinal axis “X”. Preferably, the central longitudinal “X” axis is at least substantially parallel to the longitudinal axes “Xa, Xb and Xc” of holes 102 a , 102 b and 102 c . Desirably, central hole 104 is located at the intersection of axes or lines extending orthogonally through the longitudinal axes “Xa, Xb and Xe” of holes 102 a , 102 b and 102 c. As seen in FIGS. 2 and 3 , introducer 100 may have a substantially triangular geometric configuration including corners 106 a , 106 b and 106 c and side walls 108 a , 108 b and 108 c . It is envisioned that a hole 102 a , 102 b and 102 c is formed near a respective corner 106 a , 106 b and 106 c of introducer 100 . Desirably, each corner 106 a , 106 b and 106 c of introducer 100 is rounded or radiused. Additionally, side walls 108 a , 108 b and 108 c may be planar and, desirably, as seen in FIGS. 2 and 3 , may be concave. In accordance with the present disclosure, introducer 100 functions to hold or maintain electrodes 1 , 2 and 3 of electrode system “E” substantially parallel to one another and at a defined distance from one another during the use thereof. It is envisioned that a guide needle 110 may be advanced through center hole 104 of introducer 100 and advanced to the desired target tissue using known medical imaging techniques (e.g., ultrasound, computer tomography, magnetic resonance imaging, X-ray, CT scan, etc.) In one embodiment, as seen in FIG. 3 , it is envisioned that center hole 104 may be eliminated and guide needle 110 may be operatively secured to the center of introducer 100 (i.e., at the central longitudinal “X” axis). In the present embodiment, introducer 100 may be introduced or advanced to the target tissue in a manner similar to that described above. Turning now to FIGS. 4-9 , an introducer, in accordance with an alternative embodiment of the present disclosure, is generally designated as 200 and is shown in operative association with a cluster electrode system “E”. Introducer 200 includes a first or proximal introducer 210 and a second or distal introducer 220 . Desirably, as seen in FIG. 4 , proximal introducer 210 and distal introducer 220 are used in cooperation with or in combination with one another to hold or maintain electrodes 1 , 2 and 3 of electrode system “E” substantially parallel to one another, at a defined distance from one another and/or at a defines location relative to one another during the use thereof. Turning now to FIGS. 5 and 6 , proximal introducer 210 includes a plurality of radially oriented rows 212 of holes 214 formed therein. Preferably, each row 212 is equally spaced from one another by an angle “Θ” relative to one another. As seen in FIGS. 5 and 6 , proximal introducer 210 may include six (6) rows 212 of holes 214 which are spaced from one another by an angle “Θ” approximately equal to 60°. Desirably, each hole 214 includes a longitudinal axis which is at least substantially parallel to one another. In accordance with an embodiment of the present disclosure, each hole 214 may have a diameter of approximately 0.085 in. (2.16 mm) Proximal introducer 210 further includes a central hole 216 formed therethrough. Central hole 216 defines a central longitudinal axis “X”. Preferably, the central longitudinal “X” axis is at least substantially parallel to the longitudinal axes of holes 214 . Desirably, central hole 216 is located at the intersection of rows 212 . As seen in FIGS. 5 and 6 , a first set of rows 212 a includes six (6) holes 214 a formed therealong. Desirably, rows 212 a of holes 214 a are spaced from one another by an angle “Φ” approximately equal to 120°. A second set or rows 212 b includes seven (7) holes 214 b formed therealong. Desirably, rows 212 b of holes 214 b are spaced from one another by an angle “Φ” approximately equal to 120°. Preferably, the respective holes 214 a of the first set of rows 212 a define an equilateral triangle therebetween. Accordingly, in one embodiment, the distance between respective inner-most holes 214 a 1 is approximately 0.984 in. (25.0 mm). The distance between respective second inner-most holes 214 a 2 is approximately 1.378 in. (35.0 mm). The distance between respective third inner-most holes 214 a 3 is approximately 1.772 in. (45.0 mm). The distance between respective fourth inner-most holes 214 a 4 is approximately 2.165 in. (55.0 mm). The distance between respective fifth inner-most holes 214 a 5 is approximately 2.559 in. (65.0 mm). The distance between respective sixth inner-most holes 214 a 6 is approximately 2.953 in. (75.0 mm). Preferably, the respective holes 214 b of the second set of rows 212 b also define an equilateral triangle therebetween. Accordingly, in one embodiment, the distance between respective inner-most holes 214 b 1 is approximately 0.787 in. (20.0 mm). The distance between respective second inner-most holes 214 b 2 is approximately 1.181 in. (30.0 mm). The distance between respective third inner-most holes 214 b 3 is approximately 1.575 in. (40.0 mm). The distance between respective fourth inner-most holes 214 b 4 is approximately 1.969 in. (50.0 mm). The distance between respective fifth inner-most holes 214 b 5 is approximately 2.362 in. (60.0 mm). The distance between respective sixth inner-most holes 214 b 6 is approximately 2.756 in. (70.0 mm). The distance between respective seventh inner-most holes 214 b 7 is approximately 3.150 in, (80.0 mm). Desirably, as seen in FIGS. 5 and 6 , proximal introducer 210 may have a substantially circular geometric profile. In one embodiment, proximal introducer 210 may have a diameter approximately 4.0 in. (102.0 mm). It is further envisioned that proximal introducer 210 may have a thickness of approximately 0.38 in. (9.65 mm). Turning now to FIGS. 7-9 , distal introducer 220 is similar to proximal introducer 210 and will only be discussed in detail to the extent necessary to identify differences in construction and operation. Distal introducer 220 includes a plurality of radially oriented rows 222 of holes 224 formed therein. Preferably, distal introducer 220 includes six (6) rows 222 of holes 224 which are spaced from one another by an angle “Θ” of approximately 60°. In accordance with an embodiment of the present disclosure, each hole 224 may have a diameter of approximately 0.085 in. (2.16 mm). Preferably, the number and location of holes 224 of distal introducer 220 is substantially identical to the number and location of holes 214 of proximal introducer 210 . As seen in FIGS. 7 and 8 , a first set of rows 222 a includes six (6) holes 224 a formed therealong. Desirably, rows 222 a of holes 224 a are spaced from one another by an angle “Φ” of approximately 120°. A second set or rows 222 b includes seven (7) holes 224 b formed therealong. Desirably, rows 222 b of holes 224 b are spaced from one another by an angle “Φ” of approximately 120°. As seen in FIGS. 7 and 8 , a central hole 226 formed therethrough. Central hole 226 defines a central longitudinal axis “X”. Preferably, the central longitudinal “X” axis is at least substantially parallel to the longitudinal axes of holes 224 . Desirably, central hole 226 is located at the intersection of rows 222 . As seen in FIGS. 7-9 , distal introducer 220 further includes rows 223 a and 225 a of holes 226 a formed on either side of each row of holes 224 a the first set of rows 222 a and rows 223 b and 225 b of holes 226 b formed on either side of each row of holes 224 b of the second set of rows 222 b . Desirably, each row 223 a and 225 a includes six (6) holes corresponding, one each, to holes 224 a for each row 222 a . Additionally, each row 223 b and 225 b desirably includes seven (7) holes corresponding, one each, to holes 224 b for each row 222 b. As seen in FIGS. 8 and 9 , holes 226 a , of rows 223 a and 225 a , and holes 226 b , of rows 223 b and 225 b , are offset a radial distance outward from corresponding holes 224 a and 224 b , respectively. In particular, a central axis of each hole 226 a is desirably spaced a distance “d” from a central axis of a corresponding hole 224 b of the first set or rows 222 b by an amount of approximately 0.198 in. (5.0 mm) at an angle “α” of approximately 30.00° relative to an axis “R” extending radially through holes 224 b (e.g., a diameter or radius of distal introducer 220 ). Desirably, radially outer-most holes 226 b of rows 223 b and 225 b and radially outer-most hole 224 b of row 222 b define a cluster “C” with holes 224 b and 226 b is a substantially equilateral configuration. As such, cluster “C” may receive three smaller or thinner needles to achieve the same effect as compared to a single larger needle. A plurality of clusters “C” are desirably defines along each row 222 a and 222 b. Desirably, a central axis of each hole 226 b is also spaced a distance “d” from a central axis of a corresponding hole 224 b of the second set or rows 222 b by an amount of approximately 0.198 in. (5.0 mm) at an angle “α” of approximately equal to 29.67° relative to an axis “R” extending radially through holes 224 a (e.g., a diameter or radius of distal introducer 220 ). Desirably, as seen in FIGS. 7 and 8 , distal introducer 220 may have a substantially circular geometric profile. In one embodiment, distal introducer 220 may have a diameter of approximately 4.0 in. (102.0 mm). It is further envisioned that distal introducer 220 may have a thickness of approximately 0.375 in. (9.925 mm). While a circular geometric profile is shown, it is envisioned and within the scope of the present disclosure that any geometric profile may be used, such as, for example, hexagonal, rectangular, star-shaped, etc. It is envisioned that proximal introducer 210 and distal introducer 220 may be fabricated from a rigid, non-conductive material (e.g., plastic, polycarbonate, etc.). Referring back to FIG. 4 , in accordance with one method of use, electrodes 1 , 2 and 3 of electrode array system “E” are positioned in holes 214 a of rows 212 a or in holes 214 b of rows 212 b , depending on the particular surgical procedure and depending on the size and characteristics of the organ to be operated on. Desirably, electrodes 1 , 2 and 3 are placed solely in corresponding holes 214 a of rows 212 a or in holes 214 b of rows 212 b . Desirably, electrodes 1 , 2 and 3 are positioned in introducer 210 in substantially equilateral triangular configurations. Depending on the size of the target lesion and the particular operative parameters to be employed and/or delivered from electrosurgical generator 16 , electrodes 1 , 2 and 3 may be placed in holes 214 a or 214 b which are either closer or further from central hole 216 . Prior to, concomitantly therewith, or subsequent thereto, distal introducer 220 is placed against the body surface of the patient at a location in the proximity to where electrodes 1 , 2 and 3 are to be introduced into the body. Desirably, a guide needle 110 (see FIG. 3 ) extending from the center of distal introducer 220 may be used to position the location of distal introducer 220 relative to the body surface of the patient. With the relative distance and orientation of electrodes 1 , 2 and 3 of electrode array system “E” set by proximal introducer 210 and with distal introducer 220 positioned against the body surface of the patient, electrodes 1 , 2 and 3 of electrode array system “E” are then inserted into desired and/or pre-determined holes 224 a , 224 b of rows 222 a or 222 b , respectively, or into desires and/or predetermined holes 226 a , 226 b of rows 223 a , 225 a or rows 223 b , 225 b. Introducer 200 , including proximal introducer 210 and distal introducer 220 help to facilitate placement of electrodes 1 , 2 and 3 of electrode array system “E” by the clinician. As mentioned above, introducer 200 may function to maintain electrodes 1 , 2 and 3 substantially parallel to one another, and at a prescribed spacing relative to one another. The prescribed spacing is determined in part by the energy delivery to the organ which may have an effect on the overall size of the lesion. Additionally, introducer 200 and, in certain instances guide needle 110 , aid the clinician in holding electrodes 1 , 2 and 3 at the appropriate and/or desired depth and at a substantially equal depth to one another. It is understood that variations in the choice of electrical output parameters from the electrosurgical generator, to control or monitor the electrode array ablation process, may vary widely depending on the operator's experience, technique, or preference. For example, in the embodiments above, a common RF voltage is applied to all of the electrodes of the array simultaneously. As an alternate embodiment, in accordance with the present disclosure, the clinician may choose to control the RF current to the individual electrodes of the array or the total current of the array as a whole. Voltage variations on each electrode could be applied to achieve constant current output from each electrode. Alternatively, constant power output from each electrode may be sought in some clinical settings. Voltage variations or phases between electrodes may be implemented to achieve desired temperature distribution in the tissue as monitored by temperature sensors in the tissue or by visualization of temperature distribution using thermally sensitive MRI scanning, for example. Accordingly, the choice of electrical output type, sequence, and levels and the distribution of the electrodes of the array should be considered to have wide variations within the scope of the present disclosure. In view of the foregoing considerations, as would be apparent by persons skilled in the art, implementations and systems should be considered broadly and with reference to the claims set forth below.

The present disclosure relates to systems, devices and methods for positioning and placing multiple electrodes in a target surgical site. An introducer is provided for facilitating the insertion of a cluster of electrodes into the body of a patient for performing tissue ablation. The introducer includes a body portion including a plurality of holes formed therein for selectively receiving a respective elongated shaft of the electrodes therethrough, wherein the holes of the introducer orient and space each electrode relative to one another, wherein the introducer includes a centrally disposed hole formed therein for receiving a guide needle therethrough.

FIELD OF THE INVENTION This invention relates to portable riding apparatus and in particular to a portable golf cart. BACKGROUND AND SUMMARY OF THE INVENTION So far as known to the inventors, golf carts are typically cumbersome and entirely motor driven vehicles that are not easily transported and do not offer any form of exercise when ridden. Golf carts are usually fairly heavy and most golf courses keep a fleet of carts available for rental by patrons of the golf course, since they are simply not readily portable. The inventors have proposed a light, portable golf riding apparatus that also in one embodiment offers optional human propulsion, in the case shown using foot driven pedals. The lightness of the apparatus is provided in part by using a tubular construction, with few, if any, panels, and portability is provided by having the apparatus formed from several sections or frameworks pivoting in relation to each other. In one embodiment, a first central section holds the power train and rear wheels, a front section holds the steering, and a third a seat for the rider. In one embodiment, the front section folds back upon the central section and the seat collapses onto the central section to make a compact and portable vehicle. Power is provided optionally by an electric motor or a free-wheeling pedal with chain attachment to the rear wheels. Further elucidation of the invention may be found in the detailed description that follows and the claims forming a part of this patent document. BRIEF DESCRIPTION OF THE DRAWINGS There will now be described a preferred embodiment of the invention, with reference to the drawings, by way of illustration, in which like numerals denote like elements and in which: FIG. 1 is a front isometric view of a portable riding apparatus according to the invention; FIG. 2 is a rear isometric view of the portable riding apparatus of FIG. 1; FIG. 3 is a top view of the portable riding apparatus of FIG. 1; FIG. 4 is a side schematic of the portable riding apparatus of FIG. 1 ready for use; FIG. 5 is a side schematic of the portable riding apparatus of FIG. 1 partially folded; and FIG. 6 is a side schematic of the portable riding apparatus of FIG. 1 fully folded. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIGS. 1, 2 and 3 in particular there is shown a portable riding apparatus 10 according to the invention. The portable riding apparatus 10 is powered by a pedal set and an auxiliary electric motor. The pedal set is formed from pedals 12 on crank arms 14, with the crank arms being attached to opposed ends of a shaft 16 that is journalled in sleeve 18. A front sprocket 20 (best seen in FIG. 4) of conventional bicycle type design on one end of the shaft 16 engages a chain 22 the top part of which is enclosed within chain guard 24. The chain 22 runs rearward to a rear sprocket 26 that is operatively connected to a rear axle 40. As well known in the bicycle manufacturing art, it is preferable that the rear sprocket 26 be of the free wheel type such that upon discontinuation of pedalling while the vehicle is in motion, the rear wheels do not drive the pedals 12. A 12V traction type electric motor 30 best seen in FIG. 3 drives a conventional belt drive 32 that engages a grooved drive wheel 34 that is fixed on rear axle 40. Rear axle 40 connects to the left rear wheel 38L on one end and to the right rear wheel 38R at the other end. A conventional lead acid battery 42 may be used to provide power for the drive motor 30 through cable 41. The drive motor 30 is controlled by push button control 43 on steering set 46 in conventional manner through cable 48. Braking is provided by lever 44 on steering set 46 that attaches to a conventional brake on the rear axle 40. The motor 30 is normally in the off position and pushing of the button 43 activates the motor 30. The frame of the portable riding apparatus includes three main parts: a central framework that supports the driving mechanism, including pedals, motor, battery, and rear axle and wheel set; a front framework that supports the front wheels and steering mechanism and a seat framework mounted on the central section that supports a seat for a rider. The central framework and the front framework together form a body for the portable riding apparatus. The central rigid framework is formed on its right side (conventional right according to a person sitting in the vehicle and looking forward) by a right upper tube 52R that is connected on one end to the sleeve 18 at the front end of the central rigid framework and the other to a cross tube 66 adjacent the axle 40 at the rear portion of the central rigid framework. A right center tube 56R extends downward from the sleeve 18 and connects to a pivot point 58, formed of a linked pair of rods 60 and 62. A right lower tube 54R extends rearward from the pivot point 58 to and beyond the cross tube 66 adjacent the axle 40. A mirror image of the right side forms the left side to the central rigid framework, with the sleeve 18, cross tube 66 and forward connecting rod 62 connecting the left and right sides. Elements on the right side are given the reference suffix R, and like elements on the left side are given the reference suffix L. Lateral tubes 64L and 64R connect between the left and right lower tubes 54L and 54R respectively and the cross tube 66 adjacent respective rear wheels 38L and 38R. The axle 40 is supported for rotation by bearings 63L and 63R that are mounted on the left lateral tubes 64L and 64R respectively. The left lower tube 54L and right lower tube 54R together form a lower portion of the central rigid framework. A plate may extend between the left lower tube 54L and the left lateral tube 64L under the motor 30 to form a support surface for the motor 30, or the motor may be bolted directly to the tubes 54L and 64L and cross tube 66. A brace between the left lower tube 54L and right lower tube 54R is provided by tube 50. The front rigid framework is formed from a right rear tube 70R that extends between rod 60 at pivot 58 and a connector 72. The connector 72 may be formed of a tube as shown or an arcuate plate that conforms to the outside surface of the sleeve 18, and the connector 72 and sleeve 18 may be locked together with any of various suitable locking means such as a toggle clamp fastened to the connector 72 that engages a groove or lip on the sleeve 18 or with a pin (not shown) or the like that is received by loops on the connector 72 and sleeve 18. The front rigid framework pivots about the pivot 58 as shown in FIGS. 5 and 6 on release of the locking means at the sleeve 18 and is held firmly against the sleeve 18 when the locking means is engaged. The front rigid framework also includes a right lower front tube 76R extending forward from the pivot 58 to a steering frame 78. A right upper front tube 80R extends between the steering frame 78 to the connector 72. The left side of the front rigid framework is a mirror image of the right side, and together with the connector 72, rod 60 forming part of pivot 58 and steering frame 78 form a rigid section. The left lower front tube 76L and the right lower front tube 76R together form a base portion for the front rigid framework. A front wheel set is attached to the frame 78 on the front rigid framework that includes wheels 82L and 82R each pivotally attached to the frame 78 at pivots 86L and 86R respectively. Extending upward from and pivotally connected to the right rear tube 70R and left rear tube 70L at points 88R and 88L respectively (or to either side of the connector 72) is a right steering column support 92R and a left steering column support 92L. The supports 92R and 92L are pivotally attached to either side of the steering sleeve 94. A short vertical tube 100 extends vertically and rigidly from sleeve 18 and terminates in a T-bar 103 forming a pivot point. Two elbows 106L and 106R are pivotally connected to and extend from left and right sides respectively of the T-bar 103 to the sleeve 94. A collapsible steering column 96 formed of an upper part 96U and a lower part 96L having a pivot point 107 (see FIG. 5) at the point of connection of the two parts passes through the sleeve 94 to a pivot point 98 attached to the steering frame 78. As shown better in FIGS. 5 and 6, when the portable riding apparatus is set up for use, the pivot point 107 is held within the sleeve 94 and the steering column is prevented from collapsing by the sleeve 94. Left and right rods 102L and 102R respectively connect the extreme lower end 96L of the steering column 96 to steering arms 104L and 104R rigidly attached to the wheels 82L and 82R respectively. Rotation of the steering column 96 turns the wheels in known manner. The steering column 96 terminates at its upper end 96U in the steering set 46. Optionally, a shield 108 may be attached to the front rigid framework to protect the rider from spray or debris. The seat framework is formed of a rear U-shaped support 110 (not shown in FIG. 3 but see the other Figures) pivotally attached at its left and right ends to left and right brackets 111L and 111R respectively mounted on lateral tubes 64L and 64R respectively adjacent the bearings 63L and 63R of the axle 40, and a pair of arms 112L and 112R that are joined together at one end by a bar 113 whose ends are pivotally connected to the left and right upper tubes 52L and 52R respectively near the sleeve 18. The arms 112L and 112R extend upward and rearward from the pivoting bar 113 to a seat 116. The arms 112L and 112R support the seat 116 with back rest 118 attached to the ends of arms 114L and 114R. The arms 112L and 112R and arms 114L and 114R respectively connect at points 120 under the seat 116. The arms 112L and 112R are fixed to the seat 116 while the arms 114L and 114R are fixed to the back rest 118 and are pivotally connected to the points 120. In normal use the arms 114L and 114R and hence the back rest 118 may be supported by the U-shaped support 110 or, as shown, a frame 124 affixed to the seat 116. The U-shaped support 110 releasably attaches to the rear of the seat 116 using any of several known releasable fastening methods such as a U-shaped connector 117 (FIG. 4) fixed to the base of the seat or the like. The arms 112L and 112R, together with the support 110 support the seat 116 in fixed position in relation to the central framework. Each of the load bearing tubes and braces is preferably tubular, though not necessarily round, and made of lightweight and strong material such as aluminum or one of the many light alloys used in bicycle construction. The respective tubes are preferably welded together in accordance with known techniques. The supports 92L and 92R and the elbows 106L and 106R may be made of flat metal bars since they are not load bearing. The pedals are conventional bicycle pedals. The wheels are chosen for the particular purpose intended, and in the case of a golf cart may be slightly larger than conventional golf cart wheels, with a wide tread to avoid damage to the fairways. The wheels shown are 8" pneumatic tires on plastic moulded rims. The seat may be made to be adjustable in height. The portable riding apparatus is primarily intended for use as a golf cart, but has other uses. When used as a golf cart, upper supports 126 complete with conventional straps 130 may be attached to frame 124 and lower supports 128R and 128L may be attached respectively between the ends of tubes 54R, 64R and 54L, 64L at the rear of the portable riding apparatus for retaining golf bags in conventional manner. Provision may also be made for carrying refreshments. However, the portable riding apparatus has other uses, for example use by the disabled, in which case the golf bag supports may be replaced by other suitable supports, as for example groceries. The manner of operation of the riding apparatus is as follows. Removal of the clamp, pin or the like locking means holding the connector 72 to the sleeve 18 allows the front rigid framework to rotate in relation to the central rigid framework from the position shown in FIG. 4 in which the front framework is forward of the central framework through the position shown in FIG. 5 to the position shown in FIG. 6 in which the lower portion of the central framework is adjacent the base portion of the front framework. By this means the body of the portable riding apparatus is foldable about a central axis between the front and rear wheel sets that is parallel to the rear axle 40 (that is, the axis is horizontal and lateral, or perpendicular to both the forward and vertical directions). As the front section rotates under the central section, the steering column 96 slides downward in sleeve 94 until the pivot point 107 on the steering column is clear of the sleeve 94 and sliding on the steering column upper part 96U, at which point the steering column may then be collapsed about the apparatus. To accommodate this movement of the sleeve 94, the supports 92L and 92R and the elbows 106L and 106R rotate about their respective pivots 88 and 103. By release of the releasable fastener, the U-shaped support 110 may be detached from the seat 116 and rotated rearward away from the seat 116 as shown in FIG. 5. The arms 112L and 112R then rotate downward about pivot bar 113 on the tubes 52L and 52R, thus collapsing the seat from its fixed position (FIG. 4) onto or close to the central rigid framework as shown in FIGS. 5 and 6. Also as shown in FIG. 5, the support 110 may then rotate forward into the position shown in FIG. 6 in which it rests on top of the seat 116. The steering column folds about the pivot 107 as shown in FIGS. 5 and 6 to wrap around the collapsed riding apparatus. By this means, a compact portable four wheeled vehicle may be obtained, that may easily be transported in the rear of a hatchback sedan. Alternative Embodiments A person skilled in the art could make immaterial modifications to the invention described and claimed in this patent without departing from the essence of the invention.

A light, portable golf riding apparatus that may be electric motor or pedal driven. The lightness of the apparatus is provided in part by using a tubular construction, with few, if any, panels, and portability is provided by having the apparatus formed from several sections or frameworks pivoting in relation to each other. In one embodiment, a first central section holds the power train and rear wheels, a front section holds the steering column, and a third a seat for the rider. The central and front sections pivot towards each other, the seat folds onto the central section and the steering collapses about the apparatus to form a compact body.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method of treating hypertension in human by orally administering an effective amount of methylreserpate of the formula (I): ##STR1## The invention also relates to a pharmaceutical composition for treating hypertension in human. The composition comprises the above mentioned methylreserpate as the active ingredient and any other additive or excipient for oral administration. 2. State of the Art Hypertension, along with cancer and heart disease, is one of the typical adult diseases and, as the number of aged persons increases so does the number of hypertensitive patients. Though therapy for hypertension is a very important problem, for various reasons no decisive method of treatment has been established. Reserpine (hereinafter referred to as "RSP") and Rescinnamin (hereinafter referred to as "RCN"), which are Rauwolfia alkaloids, have long been used as remedies for hypertension because of their prolonged antihypertensive effect. However, their use is accompanied by unpleasant side effects such as uneasiness due to central nervous system depression, depressed state and loss of vitality. Thus, clinicans have been seeking RSP-type antihypertensive agents with little or no central nervous system depressive effect. Methylreserpate (hereinafter referred to as "MR") was found in Rauwolfia Serpentina by Hoffmann et al. in 1954 [Helv. Chim. Acta., 37, 849 (1954)], and widely known as a metabolite of RSP [Dhar, M. M. et al.: J. Sci. Ind. Res., 140, 179 (1955); Glazko, A. J. et al.: J. Pharmacol. Exp. Therap., 118, 377 (1956); Dhar, M. M. et al.: Indian J. Pharmacy, 18, 293 (1956); Maggiolo, C. et al.: Proc. Soc. Exp. Biol. Med., 115, 149 (1964); and Huebner, C. F. et al.: J. Amer. Chem. Soc., 77, 469 (1955)]. Some researches were made on biologicl activity of this compound, and the following reports were made: The substance exhibited no antihypertensive effect [Dhar, M. M. et al.: J. Sci. Ind. Res., 140, 179 (1955); Dhar, M. M. et al.: Indian J. Pharmacy, 18, 293 (1956); Bein, H. J.: Pharmacol. Rev., 8, 435 (1956); and Huebner, C. F. et al.: J. Amer. Chem. Soc., 77, 469 (1955)]. Inhibitory action of central nervous system was less than that of RSP [Dhar, M. M. et al.: J. Sci. Ind. Res., 140, 179 (1955); Indian J. Pharmacy, 18, 293 (1956); Bein, H. J.: Pharmacol. Rev., 8, 435 (1956); Huebner, C. F. et al.: J. Amer. Chem. Soc., 77, 469 (1955); Rubin, B. et al.: Fed. Proc., 13, 400 (1954); Dasgupta, S. R. et al.: Brit. J. Pharmacol., 12, 529 (1957); and Plummer, A. J. et al.: Fed. Proc., 13, 395 (1954)]. There was observed no decrease of serotonin in Brain [Brodie, B. B. et al.: Science, 123, 992 (1956)], increse of histamine [Sachdev, K. S. et al.: Arch. int. Pharmacodyn. Ther., 157, 14 (1965)] and slight decrease of noradrenaline in heart and adrenals [Creveling, C. R. et al.: J. Med. Chem. 11, 596 (1968)]. We investigated and confirmed first of all that MR is readily absorbed in the digestive tract. Then, based on our detailed study of the antihypertensive effect of MR on spontaneously hypertensive rats (SHR) and dogs, we have found that orally administered MR exhibits prolonged antihypertensive effect, and, though mild, has sufficient antihypertensive therapeutic activity. Finally, we investigated the toxicity and metabolism of MR, and confirmed that MR can be safely used as an antihypertensive medicine with little risk of central nervous system depression. SUMMARY OF THE INVENTION Accordingly, the object of the present invention is to provide a novel remedy for hypertension. Another object of the present invention is to provide an antihypertensive agent which can be repeatedly administered without risk of undesirable side effects. MR, the effective ingredient of the present invention can be prepared by, for instance, simultaneously hydrolysing the 16- and 18-positions of reserpine and subsequently methylating the 16- position with diazomethane, or by solvolyzing the 18- position of reserpine with mixed solvent of methanol/cyclic ether or methanol alone [Helv. Chim. Acta., 37, 59 (1954); J. Med. Chem., 15 (No,6), 686-687 (1972)]. MR is a colorless or slightly yellow powder with a melting point between 237° and 239° C. (decomposing); and it is easily soluble in methanol, chloroform and ethanol, but hardly soluble in water. DRAWINGS FIG. 1 shows effect of MR on mean blood pressure of SHRs when administered by venous injection; FIG. 2 shows effect of MR on mean blood pressure of SHRs when administered orally; FIG. 3 shows dose-response curve of MR to SHRs; FIG. 4 shows effect of MR on systolic blood pressure when administered orally; FIG. 5 shows effect of MR on mean blood pressure of anesthesized dogs when administered by venous injection; FIG. 6 shows dose-response curves of MR to anesthesized dogs; FIG. 7 shows effect of MR on systolic blood pressure of SHRs when administered orally and repeatedly; FIG. 8 shows effect of MR on spontaneous motor activity; FIG. 9 shows weight changes of rats in oral subacute toxicity test of MR; FIG. 10 shows changes of food-intake by rats in oral sub-acute toxicity test of MR; FIG. 11 shows changes of water-intake by rats in oral sub-acute toxicity test of MR; FIG. 12 shows changes of urine volume and water-intake by rats of 100 mg/kg group in oral sub-acute toxicity test of MR; FIG. 13 shows changes of MR content in serum after oral administration; FIG. 14 shows changes of MR content in serum after administration by venous injection; FIG. 15 shows comparison of bioavailabilities of MR and RCN when orally administered to rabbits; FIG. 16 shows cumulative excretion percentage of MR into urine when orally administered or rabbits; FIG. 17 shows cumulative excretion percentage of MR into bile when administered by venous injection to rabbits; and FIG. 18 shows a process for extraction of substances discharged into urine. DETAILED DESCRIPTION OF THE EMBODIMENTS Dosage of the present medicine is, depending upon the sort and seriousness of hypertensive disease, usually 1 to 500 mg per day for a patient. Administration is oral, and any pharmaceutical preparation such as powder, table or capsule can be used. For the preparation, it is acceptable to mix the ingredient with an inorganic excipient such as magnesium carbonate, anhydrous silicic acid, synthetic aluminum silicate or calcium phosphate, with an organic excipient such as lactose, corn starch or cellulose, or with any other conventional material. The effect of MR, the effective ingredient of the present invention will be illustrated with practical data as follows: EXAMPLE 1 (a) Antihypertensive Effect of MR by Single Administration (i) Effect on Blood Pressure of SHR The effect was examined through both direct and modified tail-cuff methods using male SHRs aged 25 to 30 weeks and weighing about 300 g. In the direct cannulation method, polyethylene cannules were inserted in femoral arteries of the conscious unanesthesized SHRs under back-fixation, and MR solution was administered in an amount of 0.1 mg/100 g of weight for venous injection, and 1 ml/100 g of weight for oral administration. Changes in the blood pressure over 6 hours were measured with a multi-purpose polygraph RM-85 made by NIHON KODEN Co., Ltd. MR was dissolved in 0.9% NaCl aqueous solution with 1 N-HCl, and the solution was neutralized for use. In the modified tail-cuff method, MR was dispersed in 0.2% carboxymethyl cellulose solution, and the suspension was orally administered (1 ml/100 g of weight), and then, changes in blood pressure over 72 hours were measured with a blood pressure recorder 8002 made by W+W Electronic. When the measurements were made operatively after venous injection in the amounts of 2, 4 and 8 mg/kg, average rate of decrease in blood pressure was calculated from the depression area over a period of 6 hours (results are as shown in FIG. 1, 13%, 22.5% and 28%), and dose-related antihypertensive effect was observed. In every case, the effect observed was an immediate decrease in blood pressure after administration which continued for 4 to 5 hours, at which time blood pressure reached nearly level plateaus. In the cases where 4, 8 and 16 mg/kg of MR were orally administered and where the measurements were made operatively, the same dose-related antihypertensive effect as obtained with the venous injection was observed as shown in FIG. 2. The observed effect was as follows: in case of 4 mg/kg, blood pressure slowly decreased from 2 hours after the administration and the decrease reached 18% 6 hours after; in the cases of 8 and 16 mg/kg, blood pressure gradually decreased from the administration and the decrease reached 26% and 37% respectively 6 hours after. The values of DB 20 (20% blood pressure descending dose) obtained from the dose-response curves of FIG. 3 were 3.5 mg/kg for the venous injection, and 11.9 mg/kg for the oral administration. When MR was orally administered in the amounts of 6.25, 12.5 and 25.0 mg/kg and the measurements were made non-operatively, maximum rates of blood pressure decrease were, as shown in FIG. 4, 31.7%, 37.1% and 42.5% respectively, which correspond to dose-related antihypertensive effect. In every case, the observed effect was a decrease in blood pressure immediately after the administration and then, after 3 to 4 hours, went up to a plateau. The blood pressure gradually returned to its original level from about 12 hours after that, and reached its original level in 48 hours in the cases of 6.25 and 12.5 mg/kg, and in 72 hours in the case of 25 mg/kg. (ii) Effect on Blood Pressure of Anesthesized Dogs Male and female adult mongrel dogs weighing about 10 kg were anesthesized with sodium pentobarbital (35 mg/kg, venous injection), fixed at back position, and tracheal cannules were inserted by incision at cervical medial lines. Then, after insertion of polyethylene cannules in femoral arteries, MR solution was injected in an amount of 0.5 to 1 mg/kg through polyethylene cannules inserted in the branchial vein. Changes in blood pressure were measured for 6 hours after the administration with a multi-purpose polygraph RM-85 made by NIHON KODEN. MR was dissolved in 0.9% NaCl aqueous solution with 1 N-HCl, and the solution was neutralized for use. In the cases where MR was intravenously injected in the amounts of 1, 3 and 9 mg/kg, average rates of blood pressure decrease calculated from depression area within 6 hours were 16.2, 22.3 and 35.1% respectively, and dose-related depressor effect was observed. The observed effect was a blood pressure decrease immediately after administration which came up nearly to plateau 2 hours after for 1 mg/kg, and 3 hours after for 3 mg/kg and 9 mg/kg, and in all cases remained on the plateau for 6 hours after that. The DB 20 value obtained from the dose-response curve of FIG. 6 was 2 mg/kg. (b) Antihypertensive Effect of MR by Repeated Administration The effect was determined through a direct cannulation by using male SHRs aged 25 to 30 weeks and weighing about 300 g. MR was suspended in 0.2% carboxymethyl cellulose solution and the suspension was orally administered (1 ml/100 g of weight) once a day over 2 weeks. Blood pressures were measured twice a day, just before and 4 hours after the administration with blood pressure recorder 8002 made by W+W Electronic. Non-operative determination showed average rates of blood pressure decrease of 20 to 40% at 4 hours after the administration in every case, and 24 hours after the blood pressure had returned almost to the original level. Thus, the observed effect was nearly the same as the single administration over a term of 2 weeks. From the fact that MR is the metabolite of RSP, it was cared that MR has no long lasting effect, which was proved by the above described pharmacological experiments of single administration and repeated administration to SHRs. Also, from the fact that, in the repeated administration, MR exhibited nearly constant antihypertensive effect over 2 weeks, it was found that MR has the characteristic of hardly giving tolerance as one of RSP-type medicine. Because the effect of MR disappears more rapidly than that of RSP or the like, it will be understood that administration 2 to 3 times per day is necessary if used as an antihypertensive agent. Table 1 shows the antihypertensive effect of MR in comparison with conventional hypertensive remedies. It is understood that the effect of MR, compared with that of RCN, is less intense when administered by venous injection, but almost the same when administered orally. TABLE 1______________________________________Comparison of Effects of MR and ConventionalAntihypertensive Remedies Blood Pressure Decreasing Effect DB.sub.20 (mg/kg) Rate of EffectsMedicines P. O. I. V.______________________________________MR 11.9 3.5 (1.00) (1.00)RSP 3.8 0.2 (3.11) (17.7)RCN 9.7 1.3 (1.22) (2.70)Dimethylaminoethyl reser- 625.2 415.7pilinate dihydrochloride (0.02) (0.01)Hydralazine hydrochloride 6.4 0.3 (1.85) (11.7)L-alpha-methyl-dopa 1744 303.4 (0.01) (0.01)Hexamethonium chloride 320.5 39.7 (0.04) (0.08)Trichlormethiazide 149.9 79.8 (0.07) (0.05)______________________________________ In order to prove that MR is a medicine of high safety, experimental results on side effect and toxicity will be shown below. EXAMPLE 2 Effects on Central Nervous System MR was suspended in 0.2% carboxymethyl cellulose solution, and the suspension was orally administered to male mice of dd-strain weighing 23 to 27 g in an amount of 1 ml/100 g of weight. Effects on central nervous system were studied as follows: (a) Effect on Spontaneous Motor Activity 25 mg/kg of MR were administered to the mice. After 15 minutes of letting them alone, spontaneous motor activity over 6 hours was measured hourly with an "Animex" made by AB Farad. The administration of MR tended to supress spontaneous motor activity from 3 hours after the administration, and no significant difference (P=0.05) was observed in average suppressive effect among four groups of five mice each. (b) Effect on Hexobarbital Hypnosis MR was administered to 10 mice per one group in the amounts of 12.5 mg/kg or 25 mg/kg, and 6 hours later, 100 mg/kg of sodium hexobarbital were intraperitoneally injected. Period of induced sleeping was measured with righting reflex as a parameter. MR did not influence, as seen from Table 2, the time required to induce sleep nor the sleeping period. TABLE 2______________________________________Effect of MR on Hexobarbitol Hypnosis Hypnotic Time Sleeping Time (sec.) (min.)______________________________________Control Group 151±7 34.4±3.1Group of 12.5 mg/kg 144±7 32.9±4.4Group of 25 mg/kg 159±7 34.2±6.7______________________________________ (c) Effect on Body Temperature 25 mg/kg of MR was administered to 10 mice per one group, and rectal temperatures were measured with Thermister-Thermometer MGA-III-219 made by NIHON KODEN Co., Ltd. Administration of MR resulted in, as shown in Table 3, a slight decrease in the temperature 3 hours after the administration. TABLE 3______________________________________Effect of MR on Body Temperature After Administration 1 Hour 2 Hours 3 Hours______________________________________Control Group 36.3±0.2° C. 36.4±0.1° C. 36.2±0.2° C.Group of 25 mg/kg 36.6±0.2° C. 36.2± 0.2° C. 35.6±0.1° C.______________________________________ (c) Effect on Motorability 25 mg/kg of MR were administered to 10 mice per one group. The mice were put on a wooden bar of 2 cm diameter which rotated at 10 r.p.m., and the number of mice which fell down from the bar was counted. Administration of MR showed, as seen from Table 4, slight suppression of motorability 3 hours after the administration. TABLE 4______________________________________Effect of MR on Motorability Number of Number of Animals that fell Animals After Administration Examined 1 Hour 2 Hours 3 Hours______________________________________Control Group 10 0 1 1Group of 25 mg/kg 10 0 2 4______________________________________ From the above described behavior-pharmacological studies it can be said that the central nervous system depressing effect of MR is weaker than that of RSP. EXAMPLE 3 Acute Toxicity Table 5 shows acute toxicity of MR to mice and rats determined by a conventional testing method. As seen from the Table, values of LD 50 in the case of oral administration to mouse and rat are 210 mg/kg and 479 mg/kg respectively, which are about 10,000 times and about 24,000 times the clinical dosage of RCN having the effect nearly equal to MR. Thus, MR is considered to be a very safe medicine. TABLE 5______________________________________Acute Toxicity of MR Route ofAnimal Sex Administration LD.sub.50 (mg/kg)______________________________________Mouse male P. O. 210Mouse female I. V. 48Rat male P. O. 479______________________________________ EXAMPLE 4 Sub-Acute Toxicity of MR Test of Oral Sub-Acute Toxicity in Rats Animal used, breeding conditions and method of administration: Male rats of SD (SPF) strain aged 4 weeks were purchased and, after breeding for 10 days, those weighing 146 to 150 g were selected to form groups of 10 rats. The rate were bred in individual cages under the following conditions: temperature, 23°±2° C.; relative humidity, 55±5%; free taking of solid food (CE-2, CLEA Japan, Inc.) and tap water. The medicine was prepared by grinding MR in a mortar to fine powder and by turning to suspension in 0.2% carboxymethyl cellulose solution when used, and administered orally through a metallic stomach tube for rats. Volume of the medicine solution for one administration was dicided to be 1 ml per 100 g of weight, and the dose was administered once a day, 6 times a week over 5 weeks. The control group received the same volume of 0.2% carboxymethyl cellulose solution. Dosages were set at 5 levels: 12.5 mg/kg, 25 mg/kg, 50 mg/kg, 100 mg/kg and 200 mg/kg, which correspond respectively to 625, 1250, 2500, 5000 and 10000 times the daily clinical dosage of RCN having the equal effect to MR. (i) Observation of General Symptoms, Body Weight, Food-Intake and Water-Intake All the rats were observed daily and general symptoms noted. Weight was measured daily, average food-intake once every three days, and average water-intake once every two days. From about the 15th day for the group administered 50 mg/kg, and from about the 10th day for the group administered 100 mg/kg, blepharoptosis, roughening of fur and dirtiness of public region were observed. In the group administered 200 mg/kg, there was observed, in addition to the above symptoms, reduction of body weight, bloody cojunctival discharge, and a decrease of limb-skin temperature. All the animals died between the 2nd and 17th days, many dying 2 to 4 hours after administration. Measured values of body weight, food-intake and water-intake are shown in FIGS. 9 to 11. There was no change in weight in the 12.5 mg/kg group, the 25 mg/kg group and the 50 mg/kg group throughout the testing period. On the other hand, in the 100 mg/kg group there was observed a tendency toward inhibition of weight gain which increased in intensity with time beginning shortly after administration; and in the 200 mg/kg group decrese of weight. No difference was observed in food-intake in comparison with the control group except for the 200 mg/kg group. Water-intake increased a little for the 100 mg/kg group, but there was no change for the other groups. (ii) Hematological Examinations On the 10th day, the 20th day and the 30th day measurements were made as follows: red blood cell count and white blood cell cont (with a Celloscope 401, AB Larsljungberg & Co.); hematocrit value (capillary method by high-speed centrifuge); hemoglobin value (cyanmetohemoglobin method); platelet count (Toa Platelet Counter PL-100); and hemogramme (Giemsastaining). The results are given in Table 6. In the 100 mg/kg group and the 200 mg/kg group there was observed an increase in red cell count and a decrease in white cell count, but no significant change was observed in the other groups throughout the testing period. TABLE 6__________________________________________________________________________(×10.sup.Hematological Observation in Rats Treated Orally with MRfor 30 DaysNo. Days ofof Treat- R.B.C. W.B.C Platelet Hb. Ht. Differentiation of W.B.C. (%)Rats ment (x10.sup.4 /mm.sup.3) (×10.sup.2 /mm.sup.3) (×10.sup.3 /mm.sup.3) (g/dl) (%) Neutro. Eosino. Lymph. Mono.__________________________________________________________________________Control 9 10 768±17.8 162±7.3 760±52.8 14.8±0.15 50.6±1.42 15.1±1.4 1.7±0.3 73.6±8.3 2.6±0.4Control 10 20 849±9.9 174±10.9 856±30.1 13.3±0.63 51.5±1.43 17.6±1.9 1.7±0.4 78.2±2.1 2.5±0.3Control 10 30 895±13.7 154±9.6 682±30.1 13.4±0.25 50.1±0.56 16.2±1.9 1.6±0.3 80.7±1.8 1.6±0.312.5 10 10 770±15.1 151±7.2 816±49.4 14.5±0.37 52.4±1.10 15.7±1.8 1.6±0.4 80.6±1.7 2.1±0.2mg/kg12.5 10 20 879±12.6 168±5.6 866±41.4 13.2±0.53 54.5±0.97 19.4±2.1 2.4±0.5 76.4±2.1 1.8±0.4mg/kg12.5 10 30 890±8.4 163±9.4 643±43.9 14.5±0.29 50.2±0.55 18.1±1.8 2.4±0.5 78.3±1.9 1.2±0.3mg/kg25.0 10 10 774±16.4 161±7.8 853±32.6 14.2±0.65 52.4±1.01 14.6±1.6 1.5±0.3 81.8±2.0 2.1±0.4mg/kg25.0 10 20 872±22.0 179±12.8 834±42.5 13.0±0.61 51.9±0.56 22.8±2.2 1.8±0.4 74.8±2.1 1.2±0.3mg/kg25.0 10 30 913±8.7 140±6.5 658±26.8 13.3±0.52 49.8±0.52 19.2±1.9 1.4±0.6 78.0±2.0 1.5±0.5mg/kg50.0 10 10 771±10.8 143±10.5 861±33.5 14.1±0.40 52.2±0.92 13.5±0.8 1.8±0.4 82.3±1.1 2.4±0.3mg/kg50.0 10 20 864±19.8 162±9.9 834±37.1 13.8±0.33 52.6±0.86 22.1±2.2 1.3±0.4 75.0±2.3 1.6±0.3mg/kg50.0 10 30 901±15.1 153±12.5 656±36.7 14.7±0.42* 50.8±0.53 17.5±1.8 2.6±0.5 78.7±1.8 1.2±0.2mg/kg100.0 10 10 805±17.3 116±5.8* 782±31.2 15.1±0.58 52.8±0.74 18.3±2.3 2.3±0.5 77.1±2.2 2.3±0.3mg/kg100.0 10 20 908±17.2* 145±9.2 862±22.5 13.8±0.35 52.9±0.99 27.6±2.9 1.2±0.3 69.6±3.0 1.6±0.3mg/kg100.0 10 30 915±15.1 142±7.2 696±13.9 13.6±0.26 51.0±0.93 21.9±1.9 1.4±0.4 75.2±1.6 1.5±0.3mg/kg200.0 4 10 877±69.2* 115±19.1* 592±54.7 18.3±1.63* 56.6±3.50 61.8±12 0.8±0.5 36.3±12 1.3±0.5mg/kg200.0 0 20 -- -- -- -- -- -- -- -- --mg/kg200.0 0 30 -- -- -- -- -- -- -- -- --mg/kg__________________________________________________________________________ *Significant difference from control (P 0.05). The values represent mean ± standard error. (iii) Urinanalysis Urinanalysis was conducted on the last day of the repeated administration as to pH, protein content, glucose content, ketone body content and occult blood by testing paper methods. (Labstix, Miles-Sankyo Co., Ltd.) As seen from Table 7, the results do not indicate abnormal feature any worth special mention. FIG. 12 shows daily amounts of urine of 10 animals of 100 mg/kg group and of 5 animals of the control group from the 19th day of the administration. The urine volume of the 100 mg/kg group was about 2 to 3 times the volume of the control group. TABLE 7______________________________________Urianalysis in 10 Rats treated with MRfor 30 days (Sub-Acute Toxicity) Number of Rats 12.5 25.0 50.0 100.0 Control mg/kg mg/kg mg/kg mg/kg______________________________________pH 6 3 3 2 1 2 7 5 4 7 7 7 8 2 3 1 2 1Protein - 1 0 0 0 1 + 5 5 6 6 3 ++ 4 3 4 4 3 +++ 0 2 0 0 3Glucose - 10 10 10 10 10Ketone - 10 10 10 9 9Body + 0 0 0 1 1Occult - 10 10 10 10 10Blood______________________________________ (iv) Serum-Biochemical Examination After the final administration followed by 24 hours fast, the following analyses were made: Glucose (by o-toluidine-boric acid method); Total Protein (by biurett method); Blood Uria Nitrogen (diacetyl monoxime method); GOT and GPT Activities (Reitman-Frankel method); Alkaline Phosphatase Activity (Kind-King method); and Sodium and Potassium Content (flame-photometer). The results are shown in Table 8. There was observed decrease of glucose value in the 50 mg/kg group and the 100 mg/kg group. The results of the other determination were, though there were certain fluctuations, all within the scope of normal values. TABLE 8__________________________________________________________________________Serum Biochemical Analysis of Rats Treated Orally with MR for 30 Days Control 12.5mg/kg 25.0mg/kg 50.0mg/kg 100.0mg/kg No. of No. of No. of No. of No. of Rats Mean±S.E. Rats Mean±S.E. Rats Mean±S.E. Rats Mean±S.E. Rats Mean±S.E.__________________________________________________________________________Total Protein(g/dl) 10 6.94±0.16 10 7.06±0.09 10 6.65±0.08 10 6.76±0.18 9 6.57±0.28GOT (K.U.) 10 86.7±5.42 10 80.4±7.55 9 92.2±8.74 10 117.1±10.48* 10 114.9±7.02*GPT (K.U.) 10 34.2±1.02 10 32.0±1.16 9 36.6±1.55 10 38.8±2.21 9 32.7±1.67ALP (K.A.U.) 10 20.6±1.60 9 18.8±10.82 10 17.0±0.93 10 18.7±1.39 9 22.7±2.91Glucose(mg/dl) 10 147.7±3.33 10 149.3±3.36 9 155.4±6.06 9 113.7±5.25* 9 100.5±8.60*BUN (mg/dl) 10 13.6±0.64 10 14.6±0.35 8 15.7±0.77 9 17.2±0.56* 8 17.5±1.01*Na.sup.30 (mEq/l) 10 145.7±0.89 10 148.9±1.59 9 146.9±2.08 8 147.4±1.01 8 148.6±1.40K.sup.+ (mEq/l) 10 4.53±0.10 10 4.53±0.11 9 4.65±0.09 8 4.76±0.13 8 4.86±0.12__________________________________________________________________________ *Significant difference from control (P<0.05) (v) Histopathological Examination Rats were sacrificed under anesthesia with ether. After observation of gross appearance of all the organs, extraction and weighing were made on spleen, lung, liver, adrenal, heart, thymus, kidney, testicles, hypophysis and thyroid. In addition to the above organs, femoral bone marrow, lymph node, stomach, intestine, pancreas, urinary bladder, prostate and central nervous system were removed and fixed in 10% formaline solution. Five samples were randomly selected from each group, and paraffin-sectioned preparations of the organs were made by a routine method. The preparations were stained with hematoxyline-eosin stain and Luxol-fast blue (central nervous system only) and examined histopathologically. There was no noteworthy change as to the gross appearance of the organs of the subject animals. Table 9 and Table 10 show recorded absolute organ weights and relative organ weights. With respect to the absolute weights, weight increase of adrenal was observed in 25 mg/kg group and 50 mg/kg group. The group of 100 mg/kg administration had, in addition to the above change, decrease in weight of the other organs. As to the relative weights, though there were certain differences between the administered groups and the control group, no significant difference was noted on the whole. The histological findings are as follows; and the findings on each rat are as given in Table 11. Spleen: 5/5 rats of the 200 mg/kg group had slight to moderate atrophy, and 4/5 rats of the 100 mg/kg group had slight to moderate congestion. Bone Marrow: The examination was made on femoral bone marrow. Moderate hypoplasia was observed in 2/2 rats of the 200 mg/kg group, and slight hypoplasia in 3/5 rats of the 100 mg/kg group. Lung: A change like interstetitial pneumonia was observed in 5/5 rats of the 200 mg/kg group, and among them, 2/5 rats had marked congestion. Liver: In 5/5 rats of the 200 mg/kg group, there was observed necrosis and collapse or vacuolation of liver cells at central zone of the lobules. In some of the rats, inclusive of the control group, there were found here and there lymphocytic cell infiltration in Glisson's capsule or liver cell cords, and swelling of Kupffer cells. Adrenal: 1/5 rat of the 25 mg/kg group, 5/5 rats of the 50 mg/kg group and 100 mg/kg group, and 1/5 rat of the 200 mg/kg group had cortical hypertrophy. Heart: Some of the rats including the control group had focal collapse of heart muscles. Thymus: Marked atrophy was observed in 2/2 rats of the 200 mg/kg group. No other pathological change was found in the other organs: lymph mode, stomach, intestine, pancreas, kidney, urinary bladder, testicle, prostate, hypophysis, thyroid and central nervous system. TABLE 9__________________________________________________________________________Absolute Organ weights of Rats Treated Orally with MROrgan Control 12.5mg/kg 25.0mg/kg 50.0mg/kg 100.0mg/kg__________________________________________________________________________Heart (g) 1.17±0.03 1.15±0.04 1.26±0.03 1.34±0.07 1.16±0.04Spleen (g) 0.64±0.03 0.69±0.03 0.71±0.03 0.73±0.03 0.56±0.03Lung (g) 2.24±0.12 1.32±0.12 2.35±0.05 2.26±0.10 2.10±0.06*Liver (g) 10.12±0.47 10.18±0.50 10.00±0.47 10.16±0.33 7.55±0.32*Kidney (g) 1.18±0.04 1.17±0.05 1.20±0.04 1.19±0.03 0.89±0.03**Brain (g) 2.28±0.03 2.28±0.03 2.26±0.04 2.26±0.03 2.17±0.04*Thymus (g) 0.59±0.03 0.63±0.04 0.54±0.02 0.58±0.05 0.39±0.03**Testis (g) 1.60±0.03 1.63±0.05 1.71±0.10 1.68±0.03 1.51±0.09Salivary (g) 0.31±0.01 0.27±0.01 0.26±0.01** 0.26±0.01* 0.21±0.01**Adrenal (mg) 24.55±0.96 24.95±1.42 27.86±1.69 33.17±2.22 34.92±1.38**Thyroid (mg) 9.19±0.39 8.59±0.50 10.07±0.55 8.55±0.50 7.86±0.38Hypophysis (mg) 10.77±0.62 10.60±0.41 11.98±0.44 11.93±0.48 10.46±0.17__________________________________________________________________________ *Significant difference from control (P<0.05). **Significant difference from control (P<0.01) The values represent mean±standard error. TABLE 10__________________________________________________________________________Relative Organ Weights of Rats Treated Orally with MROrgan Control 12.5mg/kg 25.0mg/kg 50.0mg/kg 100.0mg/kg__________________________________________________________________________Heart (g) 0.41±0.01 0.42±0.01 0.44±0.01 0.48±0.02* 0.55±0.02**Spleen (g) 0.22±0.01 0.25±0.01** 0.25±0.01* 0.26±0.01 0.26±0.01**Lung (g) 0.84±0.05 0.84±0.04 0.82±0.03 0.93±0.04 0.99±0.02Liver (g) 3.46±0.07 3.67±0.11 3.46±0.17 3.62±0.14 3.57±0.14Kidney (g) 0.41±0.01 0.42±0.01 0.42±0.01 0.42±0.01 0.42±0.01Brain (g) 0.79±0.02 0.83±0.03 0.79±0.02 0.81±0.03 1.03±0.03**Thymus (g) 0.21±0.01 0.23±0.02 0.23±0.01 0.21±0.02 0.19±0.01Testis (g) 0.6±0.02 0.59±0.01 0.65±0.05 0.60±0.02 0.73±0.03**Salivary (g) 0.11±0.00 0.11±0.00 0.09±0.00* 0.10±0.00Adrenal (mg) 8.42±0.18 9.01±0.47 9.67±0.42 11.75±0.77 16.60±0.82Thyroid (mg) 3.18±0.15 3.10±0.17 3.53±0.19 3.04±0.18 3.71±0.09**Hypophysis (mg) 3.68±0.13 3.79±0.11 4.15±0.12* 4.20±0.10** 4.98±0.19**__________________________________________________________________________ *Significant difference from control (P<0.05). **Significant difference from control (P<0.01). The values represent mean±standard error. Organ weight/100g weight TABLE 11-A__________________________________________________________________________Histopathological Findings of Rats Treated Orally with MR Identification Nos. Control 12.5 mg/kg 25.0 mg/kgOrgan Tissue Change 1 2 3 4 5 11 12 13 14 15 21 22 23 24 25__________________________________________________________________________Heart Epicardium - - - - - - - - - - - - - - - Myocardium Focal collapse - + - - - + - - + - - - - - - Endocardium - - - - - - - - - - - - - - -Spleen Atrophy - - - - - - - - - - - - - - - Congestion - - - - - - - - - - - - - - + Haemosiderosis + + + + + + + + + + + + + + +Lymph node - - - - - - - - - - - - - - -Bone marrow Hypoplasia - - - - - - - - - - - - - - -Lung Alveolus Pneumonia - + - - - - + - - - - - + + - Alveolar wall Pneumonia - - - - - - - - - - - - - - - Congestion - - - - - - - - - - - - - - - Bronchus Bronchitis - - - - - - - - - + - - - - -Salivary Serous gl. Atrophy - - - - - - - - - - ++ ++ ++ ++ ++ Mucous gl. - - - - - - - - - - - - - - -Stomach - - - - - - - - - - - - - - -Intestine - - - --Intestine - - - - - - - - - - -Liver Liver cell Degeneration - - - - - - - - - - - - - - - Liver cell cord Cell inf. - + - - + - - + - - - - - - + Congestion - - - - - - - - - - - - - - - Kupffer cell Swelling - + - - + - - + + - + - + - + Glisson's capsule Cell inf. - + + - + - + + + + + - - + +Pancreas - - - - - - - - - - - - - - -Kidney - - - - - - - - - - - - - - -Urine bladder - - - - - - - - - - - - - - -Testis - - - - - - - - - - - - - - -Prostate - - - - - - - - - - - - - - -Hypophysis - - - - - - - - - - - - - - /Thymus Atrophy - - - - - - - - - - - - - - -Thyroid - - - - - - - - - - - - - - -Adrenal Hypertrophy - - - - - - - - - - - - - + -Central nerve - - - - - - - - - - - - - - -__________________________________________________________________________ / : No examination - : No pathological change + : Slight change ++ : Moderate change TABLE 11-B__________________________________________________________________________Histopathological Findings of Rats Treated Orally with MR 50.0 mg/kg 100.0 mg/kg 200.0 mg/kgOrganTissue Change 31 32 33 34 35 41 42 43 44 45 51* 52* 53* 54* 55*__________________________________________________________________________HeartEpicardium - - - - - - - - - - - - - - -Myocardium Focal - - + - - - - - + - - - - + - collaspeEndocardium - - - - - - - - - - - - - - -Spleen Atrophy - - - - - - - - - - - - - - - Congestion - - - - - - ++ + + + ++ ++ ++ + + Haemoside- + + + + + + + + + + + + + + + rosisLymph - - - - - - - - - - / / / / /nodeBone Hypoplasia - - - - - - + - + + ++ / / ++ /marrowLung Alveolus Pneumonia - - + + - + + - - - - - - - -Alveolar Pneumonia - - - - - - - - - - ++ ++ ++ + +wall Congestion - - - - - - - - - - + ++ ++ ++ +++Bronchus Bronchitis - - - - - - - - - - - - - - -SalivarySerous gl. Atrophy ++ ++ ++ ++ ++ + + - + - - - - - -Mucous gl. - - - - - - - - - - - - - - -Stomach - - - - - - - - - - - - - - -Intestine - - - - - - - - - - - - - - -LiverLiver cell Degenera- - - - - - - - - - - +++ ++ ++ ++ ++ tionLiver cell Cell inf. - - - - - - + - - - + - + - -cord Congestion - - - - - + - - - ++ ++ ++ ++ ++ +++Kupffer cell Swelling - ++ - - - - + + - - ++ + + + +Glisson's Cell inf. - + - - - - + + - - - - - + -capsulePancreas - - - - - - - - - - - - - - -Kidney - - - - - - - - - - - - - - -Urine - - - - - - - - - - - - - - -bladderTestis - - - - - - - - - - - - - - -Prostate - - - - - - - - - - - - - - /Hypophysis - - - - - - - - - - - - - - -Thymus Atrophy - - - - - - - - - - +++ / +++ / /Thyroid - - - - - - - - - - / - - - /Adrenal Hyper- + + ++ + + + + + + + - - - + - trophyCentral - - - - - - - - - - - - - - -nerve__________________________________________________________________________ /:No examination -:No pathological change +:Slight change ++:Moderate change +++:Marked change *:Dead case From the above-described sub-acute toxicity test, ineffective dose and lethal dose of MR to rats are defined as 12.5 mg/kg and 200 mg/kg respectively. On the other hand, ineffective dose and lethal dose of RCN were found, from the sub-acute toxicity test which we conducted, to be 6 mg/kg and 36 mg/kg respectively. In view of the fact that an ineffective dose of MR is nearly equal to that of RCN or higher, and that a lethal dose of MR is about 3 to 5 times that of RCN, MR is considered to be a safer substance than RCN. As side effects, there were observed blepharoptosis, leukopenia, increase of urine volume, atrophy of hematopoietic organs, cortial hypertrophy of adrenal and degeneration of liver cells (in dead rats) only at the higher doses. Out of the side effects, pathological changes in adrenal and liver were not reported in connection with RCN. However, the pathological change of adrenal is a reversible hypertrophy of cortex causes by hyperfunction, and the morbid change of liver was formed only in dead animals of the highest dose. Also, taking into consideration that there was found no pathological change by histopathological examination of kidney, the increase in urine volume at higher doses seems to be a diuretic effect, which is a desirable property in a hypertensive remedy. There was observed no pathological change of stomach mucous which often occurs when RCN is used. Based on long clinical use of RSP and RCN, it can be said that MR, the metabolite thereof, has been actually, though without any recognition, used clinically, and therefore, it is concluded that MR is a hypertensive remedy of very high safety. EXAMPLE 5 This example illustrates the experiment conducted for the purpose of detailed analysis of the medical effect and the toxicity of the metabolism of MR. Animals used: Male, adult cross-bred dogs weighing about 10 kg; male rabbits weighing about 3 kg; and male S.D.-strain rats weighing about 150 g. In case of oral administration, the animals were not permitted to eat for 24 hours, except for the experiment of biotransformation. Experimental Method: MR was dispersed in 0.2% carboxymethyl cellulose solution and administered to the animals at a dose of 10 mg/kg-weight for oral administration, or 1 ml/kg-weight for veous injection. Blood was drawn from branchial vein of dogs, vein of ear of rabbits and carotic artery of rats after slaughter. Urine was collected with urine bladder catheter for rabbits and metabolic cages for rats. Gathering bile was performed with biliary duct cannulation without anesthesia. Quantitative analysis of MR in biological fluids were made in accordance with fluorescencemetry established by Glazco et al. (a) Change of MR-Content in Blood FIG. 13 and FIG. 14 show change of unchanged in serum material of dogs, rabbits and rats to which MR was administered orally or by venous injection. The pattern of the serum levels showed high corralation with the pattern of blood pressure decrease, and hence, measurement of the serum level is likely to be used as a parameter of the medical effect, and in clinical application this is expected to useful for planning the administration of MR. FIG. 15 shows bioavailability of orally administered MR in comparison with that of RCN. FIGS. 13 and 14 indicate that, in spite of the fact that MR is a metabolite of RSP and RCN, MR is more readily absorbed from digestive tracts, and that the serum level, reaches a maximum level 1 to 2 hours after the administration, and further, that the period of residence in bodies is rather longer. In regard to FIG. 15, the area under the curve of MR content in serum was calculated on the following basis: ______________________________________Bioavailability Area under the Curve of MRMedicine Content in Serum (20 mg/kg) Ratio______________________________________MR 63.6 1RCN 20.2* 0.32______________________________________ *The value based on converting the data in Figure 15 to 20 mg/kg basis. (b) Excretion into Urine and Bile FIG. 16 shows change by time of excretion percentage of MR into urine in case of oral administration to rabbits. From the figure it is recognized that 10 to 15% of the administered MR is discharged into urine within 48 hours after administration, and that the rate of discharge is the highest between 1 to 4 hours after shows a high correlation with the above-mentioned change in MR content in blood after oral administration. FIG. 17 shows change by time of excretion percentage of MR into bile in case of venous injection to rabbits. From the Figure it is recognized that an amount as small as 0.3 to 0.5% of the administered MR is discharged into bile within 6 hours after administration. As a conclusion, the main route of excretion of MR is discharge into urine. (c) Biotransformation 100 mg/kg of MR was administered to 10 rats every day over 18 days to collect urine. Extraction was carried out in accordance with the procedure given in FIG. 18 to obtain, as dichloroethane extract, 0.56 g of basic fraction. The survey on discharged substances in the fractions through thin layer chromatography disclosed that there are two kinds of excreted substances: M-I and M-II. M-I and M-II, through thin layer chromatography, were separated from ordinary components of urine to give about 220 mg and 5 mg respectively. Structural approach of M-I and M-II by NMR, MS, IR and UV proved that M-I is identical with MR, and that M-II is a demethylated product of MR at methoxy group of "A" ring. As a result of the above study through the survey of MR-originated substances having biological activities, it is concluded that MR is hardly metabolized when orally administered and mainly the unchanged MR exhibits the effects. In FIG. 16, the excretion percentage into urine is defined as a percentage of the amount discharged into urine to the amount administered; and in FIG. 17, the excretion percentage into bile is defined as a percentage of the amount discharged into bile to the amount administered.

Hypertension in human is treated by orally administering an effective amount of methylreserpate with little or no undesirable side effect such as central nervous system depression. Methylreserpate can be prepared from Reserpine, a Rauwolfia alkaloid.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims the benefit of priority to U.S. provisional application Ser. No. 60/937,169, filed Jun. 26, 2007 and to U.S. provisional application Ser. No. 61/123,263, filed Apr. 7, 2008, which are both incorporated herein by reference in their entireties. FIELD OF THE INVENTION [0002] The present invention relates to the preparation of a hydrolysable linker, which is bound to at least one semi-synthetic polymer. These hydrolysable linker are useful for extending the in-vivo circulation of protein and peptide drugs. BACKGROUND OF THE INVENTION [0003] Most protein or peptide drugs are short-lived and have often a short circulatory half-life in vivo. Considering that protein or peptide drugs are not absorbed orally, prolonged maintenance of therapeutically active drugs in the circulation is a desirable feature of obvious clinical importance. [0004] An attractive strategy for improving clinical properties of protein or peptide drugs is a modification of the drugs with polymers e.g. polyalkylene-oxides (Roberts et al., Advan Drug Rev. 54, 459-476 (2002)) or polysaccharides like polysialic acid (Fernandes et al., Biochim Biophys Acta 1341, 26-34 (1997)), dextranes or hydroxyl alkyl starch. (All documents cited in the specification are incorporated by reference.) [0005] The modification with poly(ethylene glycol) (PEG) has been known for a while. However, modification of proteins with PEG often leads to reduction of the activity of the protein. [0006] Polysialic acid (PSA), also known as colominic acid (CA), is a natural occurring polysaccharide. It is a homopolymer of N-acetylneuraminic acid with α(2→8) ketosidic linkage and contains vicinal diol groups at its non-reducing end. PSA is negatively charged and is a natural constituent of the human body. It can easily be produced from bacteria in large quantities with pre-determined physical characteristics (U.S. Pat. No. 5,846,951). Being chemically and immunologically identical to polysialic acid in the human body, bacterial polysialic acid is non-immunogenic even when coupled to proteins. Unlike other polymers (e.g.; PEG), polysialic acid is biodegradable. [0007] However, to date no therapeutic compound comprising a polypeptide conjugated to an acidic monosaccharide such as PSA is commercially available. [0008] Short PSA polymeric chains with only 1-4 sialic acid units have also been synthesized (Kang et al., Chem. Commun., 227-228 (2000); Ress et al., Current Organic Synthesis 1, 31-46 (2004)). [0009] Several hydrolysable or degradable linkers comprising PEG moieties have been suggested. [0010] U.S. Pat. No. 6,515,100, describes PEG and related polymer derivatives, having weak, hydrolytically unstable linkages U.S. Pat. No. 7,122,189 describes releasable PEG-linkers based on bis-N-2-hydroxyethyl glycine groups (bicine). [0011] WO 04/089280 and WO 06/138572 describe hydrolysable fluorene-based PEG constructs. [0012] After conjugation of these linkers to protein drugs, the protein-polymer conjugate can be regarded as a prodrug and the activity of the protein can be released from the conjugate via a controlled release mechanism. Using this concept improved pharmacokinetic properties of the drug can be obtained (Zhao et al., Bioconjugate Chem. 17, 341-351 (2006)). SUMMARY OF THE INVENTION [0013] The present invention provides a hydrolysable linker, which is bound to at least one semi-synthetic biopolymer, wherein the hydrolysable linker is conjugated to a protein or peptide drug in order to improve its in-vivo properties such as the in-vivo circulation. [0014] The present invention provides a compound of the general formula 1: [0000] [0000] wherein Z a leaving group and at least one of position 1, 2, 3, 4, 5, 6, 7 or 8 is bound to radical Y. [0015] Y is a radical containing a semi-synthetic biopolymer, which is bound to a N-succinimidyl moiety. [0016] In addition to being bound to radical Y the compound of formula 1 may optionally be bound to radical X in at least one of the available position 1, 2, 3, 4, 5, 6, 7 or 8. [0017] X is —SO 3 —R 3 . [0018] R 3 is selected from the group consisting of hydrogen, (C 1 -C 8 )-alkyl and (C 1 -C 8 )-alkyl-R 4 . [0019] R 4 is a polymer. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 shows the in-vitro hydrolysis of a FVIIa-PSA conjugate at pH 8.3. The release of the FVIIa activity was measured with the Staclot—assay (Diagnostica Stago, Asnières, France). [0021] FIG. 2 shows the shows the in-vitro hydrolysis of a FVIIa-trimer PSA conjugate at pH 8.3. The release of the FVIIa activity was measured with the Staclot—assay (Diagnostica Stago, Asnières, France). [0022] FIG. 3 shows FVIIa activity in plasma measured with a clotting assay (Staclot, Diagnostica Stago, Asnières, France). For FVIIa clotting activity the dose adjusted area under curve (AUC) was 0.014 for unmodified rFVIIa and increased to 0.015 for rFVIIa—conjugate (0—infinity). The terminal half-life increased from 2.3 to 4.4 hours and the mean residence time (MRT) from 1.4 to 2.4 hours. [0023] FIG. 4 shows the determination of the FVIIa antigen by ELISA with a polyclonal anti-human FVII antibody. For the antigen the dose adjusted AUC (0—infinity) increased from 0.010 (unmodified rFVIIa) to 0.014 (rFVIIa—conjugate), the terminal half life increased from 1.4 to 2.3 hours and the MRT from 1.5 to 2.2 hours. [0024] FIG. 5 shows FVIIa activity in plasma, measured with a clotting assay (Staclot, Diagnostica Stago, Asnières, France). The pharmacokinetic of rFVIIa-trimer-PSA conjugates is improved (-◯-) compared to native rFVIIa (-Δ-). DETAILED DESCRIPTION OF THE INVENTION [0025] The present invention provides a hydrolysable linker, which is bound to at least one semi-synthetic biopolymer, wherein the hydrolysable linker can be further conjugated to a protein or peptide drug in order to improve their in-vivo properties such as in-vivo circulation. The activity of the protein or peptide drug can be released from the conjugate via a controlled release mechanism. [0026] The following paragraphs provide general definitions and definition of various chemical moieties that make up the compounds according to the invention and are intended to apply uniformly through-out the specification and claims unless an otherwise expressly set out definition provides a broader definition. [0027] “C 1 -C 8 -alkyl” refers to monovalent alkyl groups having 1 to 8 carbon atoms. This term is exemplified by groups such as methyl, ethyl, propyl, butyl, hexyl and the like. Linear and branched alkyls are included. [0028] “Leaving groups” refers to groups, which are capable of reacting with a nucleophile present on the protein or peptide drug that forms the conjugate. This term is exemplified by groups such as N-hydroxysuccimimidyl, N-hydroxybenzotriazolyl, halogen, N-hydroxyphthalimidyl, p-nitrophenoxy, imidazolyl, thiazolidinyl thione, O-acyl ureas or other suitable leaving groups will be apparent to those of ordinary skill. For the purpose of the present invention, the protein or peptide drug thus contains one or more groups for displacement, such as an amine. Protein or peptide drug are plasma proteins or blood coagulation factors such as FVIII, VWF, FVIIa and FIX. [0029] A “semi-synthetic biopolymer” refers to a manufactured organic polymer, which is based on a naturally occurring polymer. A semi-synthetic biopolymer may also be functionalized by reactive groups in order to conjugate these functionalized semi-synthetic biopolymers to other compounds. This term “semi-synthetic biopolymer” is exemplified by linear or branched polymers such as carbohydrates, specifically such as polysaccharides. Examples of polysaccharides are PSA (polysialic acid) and HAS (hydroxyalkylstarch). [0030] “Hydrolysable” linker refers to a linker system, in which the protein is released in native form. The protein is released and the linker is split off completely. Synonyms for hydrolysable are “degradable” or “releasable” linkers. [0031] The present invention provides a compound of the general formula 1: [0000] [0000] wherein Z a leaving group and at least one of position 1, 2, 3, 4, 5, 6, 7 or 8 is bound to radical Y. [0032] Y is a radical containing a semi-synthetic biopolymer, which is bound to a N-succinimidyl moiety. [0033] In addition to being bound to radical Y the compound of formula 1 may optionally be bound to radical X in at least one of the available position 1, 2, 3, 4, 5, 6, 7 or 8. [0034] X is —SO 3 —R 3 . [0035] R 3 is selected from the group consisting of hydrogen, (C 1 -C 8 )-alkyl and (C 1 -C 8 )-alkyl-R 4 . [0036] R 4 is a polymer. Examples are hydrophilic polymers such as poly(ethylene glycol) (PEG). [0037] In one embodiment, the invention relates to a compound of formula 1, [0038] wherein Z is an N-succinimidyl ester and at least one of position 1, 2, 3, 4, 5, 6, 7 or 8 is bound to radical Y, wherein Y is: [0000] [0039] wherein POLYMER is a semi-synthetic biopolymer, preferably with a molecular weight of 1,000 Da to 300,000 Da. [0040] In one embodiment the molecular weight is 5,000-25,000, preferably 5,000-10,000. [0041] In another embodiment said semi-synthetic biopolymer is a carbohydrate, preferably a polysaccharide, preferably comprising at least 3 units of a monosaccharide. [0042] In one embodiment said polysaccharide comprises between 2-200 units, preferably between 10-100 units of a monosaccharide. [0043] In one embodiment the semi-synthetic biopolymer is a PSA derivative. [0044] In another embodiment the semi-synthetic biopolymer is bound to the succinimidyl moiety via a thioether linkage. [0045] R 1 is at each occurrence independently a (C 1 -C 8 )-alkyl. [0046] In one embodiment R 1 is at each occurrence independently selected from the group consisting of methyl, ethyl, propyl, butyl, and hexyl. [0047] R 2 is independently selected from the group consisting of —C(O)NR—, —C(O)NR—(C 1 -C 8 )-alkyl-NR—, —NRC(O)— and —NRC(O)—(C 1 -C 8 )-alkyl-NR, wherein R is independently either hydrogen or (C 1 -C 8 )-alkyl. [0048] In one embodiment R 2 is —C(O)NH—. [0049] In another embodiment R 2 is —NHC(O)—. [0050] In one embodiment the compound of formula 1 is bound to radical Y in at least one of position 1, 2, 3 or 4. [0051] In another embodiment the compound of formula 1, is bound to radical Y in at least one of position 1, 2, 3, or 4 and is further bound to radical X in at least one of position 5, 6, 7, or 8. [0052] In another embodiment the compound of formula 1, is bound to at least one radical Y in at least one of position 2 or 3 is further bound to radical X in at least one of position 7 or 8. [0053] In another embodiment the compound of formula 1 is bound to radical Y in positions 2 and 7. [0054] In another embodiment the compound of formula 1 is bound to radical Y and radical X in positions 2 and 7, respectively. [0055] In another embodiment the compound of formula 1 is: [0000] [0056] In a further embodiment, the invention relates to the preparation of a compound of formula 1. [0057] Tsubery et al., J Biol. Chem. 279, 38118-38124 (2004) described the synthesis of a hydrolysable PEG-linker for derivatization of proteins based on the Fmoc (9-fluorenyl-methoxycarbonyl)-moiety. The synthesis of MAL-FMS-OSU (9-Hydroxymethyl-2-(amino-3-maleimido-propionate)-7-sulfo fluorene N-hydroxysuccinimidyl carbonate) is described. The synthetic scheme below illustrates the synthetic steps for the preparation of a compound of formula 1 as an example, starting from a MAL-FMS-OSU derivative. [0000] [0058] wherein [0059] POLYMER is a semi-synthetic biopolymer; [0060] R 1 is at each occurrence independently a (C 1 -C 8 )-alkyl; [0061] R 2 is independently selected from the group consisting of —C(O)NR—, —C(O)NR—(C 1 -C 8 )-alkyl-NR—, —NRC(O)— and —NRC(O)—(C 1 -C 8 )-alkyl-NR, wherein R is independently either hydrogen or C 1 -C 8 -alkyl. [0062] R is independently either hydrogen or (C 1 -C 8 )-alkyl; [0063] X is —SO 3 —R 3 ; [0064] R 3 is independently selected from the group consisting of hydrogen, (C 1 -C 8 )-alkyl and (C 1 -C 8 )-alkyl-R 4 ; [0065] R 4 is a polymer; [0066] n is an integer selected from 0, 1, 2, 3, or 4; and [0067] m is an integer selected from 1, 2, 3, or 4. [0068] HS-POLYMER is a thiol-derivatized semi-synthetic biopolymer, such as [0000] [0069] A compound of formula 2 can be easily reacted with a protein or peptide drug containing one or more groups for displacement, such as amines. Preferred protein or peptide drug are blood coagulation factors such as FVIII, VWF, FVIIa, FIX. [0070] Protein and peptide drugs modified according to the above protocol have a significantly increased in-vivo circulation. The hydrolysability of the linker allows that the activity can be regained after hydrolysis, by release of the protein in its native form. An example is shown in FIGS. 1 and 2 . The restoration of the biological activity of a protein conjugate is shown in FIGS. 3 and 4 . [0071] The present invention is illustrated by the following examples without being limited thereto. EXAMPLES Example 1 Preparation of PSA Containing Terminal SH Groups [0072] Polysialic acid (Sigma) was oxidized with NaIO 4 (Fernandes et al., Biochim Biophys Acta 1341, 26-34 (1997)), and a terminal aldehyde group was formed. Then a reductive amination step with NH 4 Cl was carried out as described in WO 05/016973 and the Schiff Base was reduced with NaCNBH 3 to form PSA-NH 2 containing a terminal amino group. Subsequently a reaction with 2-iminothiolane (Pierce 26101) was performed according to the instruction leaflet of the manufacturer to prepare a modified PSA containing a terminal SH group. The molarity of the generated SH-groups was determined using Ellmans reagent. In addition the same procedure was used to introduce a SH-group in a N-Acetylneuramic acid trimer, which was obtained from TimTec, LLC, Newark, USA. Example 2 Conjugation of rFVIIa with PSA Using the MAL-FMS-OSU Linker [0073] To 15 ml of a solution of rFVIIa (0.7 mg/ml) in 50 mM phosphate buffer pH 7.2 the bifunctional linker MAL-FMS-OSU (prepared as outlined by Tsubery et al., J Biol. Chem. 279, 38118-38124 (2004)) was added (concentration: 0.5 mg/mg protein) and incubated at R.T. for 30 min. Then derivatized PSA containing a terminal SH group was prepared according to Example 1. The PSA derivative was added to the mixture (concentration: 10 mg PSA-SH/mg protein) and incubated for additional 2 hours. Then the reaction was stopped by adding an aqueous solution of 0.1 M glycine (final concentration 10 mM) and 5 mM cysteine (end concentration 0.5 mM). The free reagents were separated from the rFVIIa-PSA conjugate by ion exchange chromatography using a QHyperD F 50 μm resin (BioSepra) and a Pharmacia XK-10 column (Pharmacia XK 10; h=10 cm). The PSA-rFVIIa containing solution was applied to the column, which was subsequently washed with 10 CV equilibration buffer (20 mM sodium citrate, 20 mM NaCl, pH 6.5). Then the polysialylated rFVIIa was eluted with elution buffer (20 mM sodium citrate, 500 mM NaCl, pH 6.1). The eluate contained 0.06 mg/ml protein, the evidence of bound PSA in the conjugate was proven by the resorcinol assay (Svennerholm; Biochim Biophys Acta 24: 604-11 (1957)). For release of the activity of rFVIIa in the conjugate 450 μl of the eluate was added to 50 μl M TRIS-buffer pH 8.3 and the release of the FVIIa activity was measured (Staclot, Diagnostica Stago, Asnières, France). The results are illustrated in FIG. 2 . Example 3 Conjugation of rFVIIa with Trimer PSA Using the MAL-FMS-OSU Linker [0074] To 15 ml of a solution of rFVIIa (0.7 mg/ml) in 50 mM phosphate buffer pH 7.2 the bifunctional linker MAL-FMS-OSU (prepared as outlined by Tsubery et al., J Biol. Chem. 279, 38118-38124 (2004)) was added (concentration: 0.07 mg/mg protein) and incubated at R.T. for 30 min. Then trimer PSA (TimTec, LLC, Newark, USA) was derivatized as described in Example 1 to introduce a free SH-group. The trimer PSA-SH derivative was added to the mixture (concentration: 0.43 mg trimer PSA-SH/mg protein) and incubated for additional 2 hours. Then the reaction was stopped by adding an aqueous solution of 0.1 M glycine (final concentration 10 mM) and 5 mM cysteine (end concentration 0.5 mM). The free reagents were separated from the rFVIIa-PSA conjugate by ion exchange chromatography using a QHyperD F 50 μm resin (BioSepra) and a Pharmacia XK-10 column (Pharmacia XK 10; h=10 cm). The PSA-rFVIIa containing solution was applied to the column, which was subsequently washed with 10 CV equilibration buffer (20 mM sodium citrate, 20 mM NaCl, pH 6.5). Then the polysialylated rFVIIa was eluted with elution buffer (20 mM sodium citrate, 500 mM NaCl, pH 6.1). The eluate contained 0.06 mg/ml protein, the evidence of bound PSA in the conjugate was proven by the resorcinol assay (Svennerholm et al., Biochim Biophys Acta 24, 604-11 (1957)). For release of the activity of rFVIIa in the conjugate 450 μl of the eluate was added to 50 μl 1 M TRIS-buffer pH 8.3 and the release of the FVIIa activity was measured (Staclot, Diagnostica Stago, Asnières, France). The results are illustrated in FIG. 1 . Example 4 Conjugation of Human Serum Albumin with PSA Using the MAL-FMS-OSU Linker [0075] Human Serum Albumin (HSA) is incubated with the bifunctional linker Mal-FMS-OSU linker (prepared as outlined by Tsubery et al., J Biol. Chem. 279, 38118-38124 (2004)) in 25 mM sodium acetate buffer, pH 6.2 for 1 hour. Then the excess linker is separated by gelfiltration using Sephadex G-25 (GE-Healthcare) using the same buffer system The protein containing fractions are collected and PSA-SH (prepared according to Example 1) is added. The mixture is incubated for 2 hours at R.T. Then the conjugate is purified by anion-exchange chromatography using DEAE-Sepharose FF (GE Healthcare). The Protein-PSA conjugate is eluted with 25 mM sodium acetate buffer pH 4.5. The conjugate containing fractions are pooled and concentrated by ultrafiltration using a 10K membrane. Then the solution is diafiltrated against 25 mM sodium acetate buffer, pH 6.2. Example 5 Pharmacokinetic of rFVIIa-PSA-Conjugate in Normal Rats [0076] A rFVIIa-PSA conjugate was prepared according to Example 2 using a concentration of MAL-FMS-OSU of 0.05 mg/mg protein. 8 normal rats (4 male, 4 female) were anaesthetized and the rFVIIa-PSA-conjugate in buffer (1.3 g/L glycylglycine, 3 g/L sodium chloride, 30 g/L mannitol, 1.5 g/L CaCl 2 x2H 2 O, 0.1 g/L Tween 80, pH 5.5) was applied by intravenous injection into the tail vein in a volume dose of 10 ml per kg (1200 μg protein/kg). Unmodified rFVIIa in a dose of 1200 μg protein/kg was used as control in 8 normal rats (4 male, 4 female). Blood samples were taken from the tail artery 5 minutes, 1 hour, 2, 4, 7, 10 and 24 hours after substance application and citrated plasma was prepared and frozen for further analysis. [0077] FVIIa activity in plasma was measured with a clotting assay (Staclot, Diagnostica Stago, Asnières, France), FVII antigen was determined with an ELISA (polyclonal anti-human FVII antibody). The results were evaluated statistically. For FVIIa clotting activity the dose adjusted area under curve (AUC) was 0.014 for unmodified rFVIIa and increased to 0.015 for rFVIIa—conjugate (0—infinity). The terminal half-life increased from 2.3 to 4.4 hours and the mean residence time (MRT) from 1.4 to 2.4 hours. For the antigen the dose adjusted AUC (0—infinity) increased from 0.010 (unmodified rFVIIa) to 0.014 (rFVIIa—conjugate), the terminal half life increased from 1.4 to 2.3 hours and the MRT from 1.5 to 2.2 hours. All calculations were carried out by use of a statistical program (program R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria, ISBN 3-900051-07-0, URL http://www.R-project.org). The pharmacokinetic results are illustrated in FIGS. 3 and 4 . Example 6 Pharmacokinetic of rFVIIa-trimer-PSA-Conjugate in Normal Rats [0078] rFVIIa-trimer-PSA conjugate was prepared according to Example 3 using a MAL-FMS-OSU concentration of 0.05 mg/mg protein. 6 normal rats (3 male, 3 female) were anaesthetized and the rFVIIa-trimer-PSA-conjugate in buffer (1.3 g/L glycylglycine, 3 g/L sodium chloride, 30 g/L mannitol, 1.5 g/L CaCl 2 x2H 2 O, 0.1 g/L Tween 80, pH 5.5) was applied by intravenous injection into the tail vein in a volume dose of 10 ml per kg (1200 μg protein/kg). Unmodified rFVIIa in a dose of 1200 μg protein/kg was used as a control in 6 normal rats (3 male, 3 female). Blood samples were taken from the tail artery 5 minutes, 1 hour, 2, 4, 7, 10 and 24 hours after substance application and citrated plasma was prepared and frozen for further analysis. [0079] FVIIa activity in plasma was measured with a clotting assay (Staclot, Diagnostica Stago, Asnières, France) and the elimination curve was constructed. The improved pharmacokinetic of the rFVIIa-trimer-PSA conjugate is illustrated in FIG. 5 . Example 7 Conjugation of rFIX with PSA Using the MAL-FMS-OSU Linker [0080] To 0.6 ml of a solution of recombinant FIX (8 mg/ml) in 20 mM Hepes buffer, pH 7.4 the bifunctional linker MAL-FMS-OSU (prepared as outlined by Tsubery et al., J Biol. Chem. 279, 38118-38124 (2004)) was added (concentration: 0.07 mg/mg protein) and incubated at R.T. for 30 min. Derivatized PSA containing a terminal SH group was prepared according to Example 1. The PSA derivative was added to the mixture (concentration: 32 mg PSA-SH/mg protein−100 fold molar excess) and incubated for additional 2 hours at R.T. The reaction was stopped by adding an aqueous solution of 0.1 M glycine (final concentration 10 mM) and 5 mM cysteine (end concentration 0.5 mM). The free reagents were separated from the rFIX-PSA conjugate by Hydrophobic Interaction Chromatography using a pre-packed Butyl Sepharose column (HiTrap Butyl FF 5 ml, GE Healthcare). A buffer containing 5 M NaCl (50 mM Hepes-buffer, 5M NaCl, 0.01% Tween80, 6.7 mM CaCl 2 , pH 6.9) was added to the PSA-rFIX containing solution to give a final concentration of 3M NaCl. This mixture was applied to the column, which was subsequently washed with 10 CV equilibration buffer (50 mM Hepes-buffer, 3M NaCl, 0.01% Tween80, 6.7 mM CaCl 2 , pH 6.9) and the elution of the rFIX-PSA conjugate was carried out with 50 mM Hepes-buffer, pH 7.4, containing 6.7 mM CaCl 2 . After elution of the conjugate the pH was adjusted to pH 6.9. The eluate contained 0.24 mg/ml protein as measured by the BCA-assay, the evidence of bound PSA in the conjugate was proven by the resorcinol assay (Svennerholm, Biochim Biophys Acta 24, 604-611 (1957)). In a final step the eluate was concentrated 10 fold by ultrafiltration/diafiltration (UF/DF) using a 30 kD membrane (regenerated cellulose/Millipore) against 20 mM Hepes, 50 mM NaCl, 1 mM CaCl 2 , pH 7.4. Example 8 Conjugation of rFVIII with PSA Using the MAL-FMS-OSU Linker [0081] For the preparation of rFVIII-PSA conjugate 6 ml of a solution of recombinant FVIII (4.5 mg/ml), derived from the Advate manufacturing process, in 20 mM Hepes buffer, pH 7.4 the bifunctional linker MAL-FMS-OSU (prepared as outlined by Tsubery et al., J Biol. Chem. 279, 38118-38124 (2004)) was added (concentration: 0.315 mg/mg protein) and incubated at R.T. for 30 min. Derivatized PSA containing a terminal SH group was prepared according to Example 1. The PSA derivative was added to the mixture (concentration: 27.8 mg PSA-SH/mg protein−450 fold molar excess) and incubated for additional 2 hours at R.T. The reaction was stopped by adding an aqueous solution of 0.1 M glycine (final concentration 10 mM) and 5 mM cysteine (end concentration 0.5 mM). The free reagents were separated from the rFVIII-PSA conjugate by Hydrophobic Interaction Chromatography using a prepacked Butyl Sepharose column (HiTrap Butyl FF 5 ml, GE Healthcare). A buffer containing 5 M NaCl (50 mM Hepes-buffer, 5M NaCl, 0.01% Tween80, 6.7 mM CaCl 2 , pH 6.9) was added to the PSA-rFVIII containing solution to give a final concentration of 3M NaCl. This mixture is applied to the column, which was subsequently washed with 10 CV equilibration buffer (50 mM Hepes-buffer, 3M NaCl, 0.1% Tween 80, 5 mM CaCl 2 , pH 6.9) and the elution of the rFVIII-PSA conjugate was carried out with Citrate buffer, pH 7.4 (13.6 mM Na 3 Citrate, 20 mM CaCl 2 , 20 mM Histidine, 0.01% Tween 80). After elution of the conjugate the pH was adjusted to pH 6.9. The eluate contained 2.5 mg/ml protein (BCA assay).

The invention relates to Fmoc (9-fluorenyl-methoxycarbonyl)-based polymeric conjugates. These conjugates are useful for extending the in-vivo circulation of protein and peptide drugs.

BACKGROUND OF THE INVENTION The present invention relates generally to devices adapted for use in donning footwear and more particularly to a novel device adapted for use in donning a ski boot and to a method of using said device. The difficulties associated with donning tight-fitting articles of footwear of the type having a closed-heel are well-chronicled and are attributable in large part to the fact that while, in many instances, it is desirable to make such footwear as rigid as possible to provide protection to a foot disposed therein, such rigidity makes the insertion of a foot into the article of footwear more difficult. One common approach to this problem has been the use of a conventional shoe horn. Examples of other types of devices that are designed for use in donning footwear are disclosed in the following U.S. patents, all of which are incorporated herein by reference: U.S. Pat. No. 6,318,607, inventor Koskela, which issued Nov. 20, 2001; U.S. Pat. No. 6,065,654, inventor Evensen, which issued May 23, 2000; U.S. Pat. No. 5,974,701, inventor Busch, which issued Nov. 2, 1999; U.S. Pat. No. 5,927,573, inventors Votino et al., which issued Jul. 27, 1999; U.S. Pat. No. 5,806,729, inventor Ramon, which issued Sep. 15, 1998; U.S. Pat. No. 5,741,569, inventors Votino et al., which issued Apr. 21, 1998; U.S. Pat. No. 5,392,800, inventor Sergi, which issued Feb. 28, 1995; U.S. Pat. No. 4,718,135, inventor Colvin, which issued Jan. 12, 1988; U.S. Pat. No. 4,667,861, inventors Harrington et al., which issued May 26, 1987; U.S. Pat. No. 3,591,226, inventors Elmore et al., which issued Jul. 6, 1971; and U.S. Pat. No. 28,927, inventor Wheeler, which issued Jun. 28, 1860. As can readily be appreciated, the aforementioned difficulties associated with the donning of tight-fitting footwear are especially acute in the case of ski boots, which must be particularly rigid and tight-fitting to afford optimal protection and support to the ski boot wearer. Unfortunately, however, because of the size, shape and rigidity of most ski boots, most shoe horns and other devices of the type discussed above are of little use in helping one to don a ski boot. As a result, the typical way in which a skier dons a ski boot is to insert her foot into the boot while, at the same time, manually spreading apart the cuff portions of the boot disposed on opposite sides of the boot tongue. However, as can readily be appreciated, this task is often too onerous for many children and other weaker individuals. Consequently, it is often necessary for such individuals to enlist the aid of a second person to spread apart the opposing cuff portions of the boot while the skier inserts her foot into the boot. As can be imagined, where there are many individuals in need of assistance and a limited number of people available for help, the foregoing procedure can become quite time-consuming and can even cause a delay to those individuals who are helping others from donning their own ski boots. Moreover, it can readily be appreciated that the task of spreading apart the opposing cuff portions can be tiring, both to those working on their own ski boots and to those working on the ski boots of others. SUMMARY OF THE INVENTION It is an object of the present invention to provide a novel device adapted for use in donning a ski boot. It is another object of the present invention to provide a device as described above that overcomes at least some of the problems discussed above in connection with the donning of ski boots. It is still another object of the present invention to provide a device as described above that is adapted to be used either by the skier wishing to don her own ski boot or by a first individual wishing to help a second individual to don a ski boot. It is still yet another object of the present invention to provide a device as described above that has a minimal number of parts, that can be mass-produced and that is easy to operate. According to the above and other objects to be described or apparent from the description which follows, there is provided herein a device suitable for use in donning a ski boot, said device comprising (a) a first handle; (b) a second handle; (c) a first spreader; (d) a second spreader; and (e) means for coupling said first and second handles to said first and second spreaders so that said first and second spreaders may be pivoted away from one another by pivoting said first and second handles away from one another. In a preferred embodiment, the device comprises a wheel mounting bracket, the wheel mounting bracket comprising a proximal end, a distal end and a longitudinally-extending slot disposed therebetween. A wheel is rotatably mounted within the longitudinally-extending slot and is shaped to include a proximal extension and a distal extension. A first handle is fixed to the distal end of the wheel mounting bracket, and a second handle is fixed to the distal extension of the wheel. The first and second handles are mirror images of one another viewed along their respective longitudinal axes, each of the first and second handles being a unitary structure. The first handle is shaped to include a generally rectangular intermediate portion, a generally rectangular proximal end, a trapezoidal intermediate portion, and a distal end. The proximal end of the first handle is of reduced width as compared to the generally rectangular intermediate portion. The trapezoidal intermediate portion is disposed between the generally rectangular intermediate portion and the proximal end, said trapezoidal intermediate portion tapering in width from said generally rectangular intermediate portion to said proximal end. The distal end is of intermediate width as compared to the generally rectangular intermediate portion and the proximal end. The sides of the distal end are turned upwardly, the remainder of said first handle being coplanar. A first spreader is fixed to the proximal extension of the wheel, and a second spreader is fixed to the proximal end of the wheel mounting bracket. The first and second spreaders are mirror images of one another viewed along their respective longitudinal axes, each of the first and second spreaders being a unitary structure. The first spreader is shaped to include generally rectangular first intermediate portion. An upwardly extending, generally rectangular second intermediate portion extends distally from said generally rectangular first intermediate portion. A generally rectangular third intermediate portion extends distally from said upwardly extending, generally rectangular second intermediate portion, said generally rectangular third intermediate portion extending generally parallel to said generally rectangular first intermediate portion. The first spreader also includes a generally rectangular distal end of reduced width as compared to said generally rectangular third intermediate portion, a trapezoidal fourth intermediate portion disposed between said generally rectangular third intermediate portion and said proximal end, said trapezoidal fourth intermediate portion tapering in width from said generally rectangular third intermediate portion to said distal end. The first spreader further includes a proximal end extending proximally from said generally rectangular first intermediate portion and curving upwardly away therefrom. The wheel is provided with a plurality of teeth along its periphery. A pawl, which is pivotally mounted on the wheel mounting bracket, is engageable with the teeth and is biased towards the teeth by a spring clip so that the pawl engages the teeth in a ratchet-type manner as the handles are pivoted away from one another. To pivot the handles back towards one another (once the device has been successfully used), one pivots the pawl away from the wheel, thereby releasing the pawl from engagement with the teeth. It is a further object of the present invention to provide a method of using said device to facilitate donning a ski boot or to facilitate removal of a ski boot from a wearer. For purposes of the present specification and claims, it is to be understood that certain terms used herein, such as “on,” “over,” and “in front of,” when used to denote the relative positions of two or more components of the device, are used to denote such relative positions in a particular orientation and that, in a different orientation, the relationship of said components may be reversed or otherwise altered. Additional objects, as well as features and advantages, of the present invention will be set forth in part in the description which follows, and in part will be obvious from the description or may be learned by practice of the invention. In the description, reference is made to the accompanying drawings which form a part thereof and in which is shown by way of illustration various embodiments for practicing the invention. The embodiments will be described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that structural changes may be made without departing from the scope of the invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is best defined by the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are hereby incorporated into and constitute a part of this specification, illustrate various embodiments of the invention and, together with the description, serve to explain the principles of the invention. In the drawings wherein like reference numerals represent like parts: FIG. 1 is a side view of one embodiment of a device adapted for use in donning a ski boot, said device being constructed according to the teachings of the present invention; FIG. 2 is a perspective view of the device of FIG. 1; FIG. 3 is an enlarged fragmentary perspective view of the device of FIG. 1; FIG. 4 is an enlarged fragmentary perspective view of the device of FIG. 1, the bracket member thereof not being shown to reveal components otherwise obscured thereby; FIG. 5 is an enlarged perspective view of the handle shown in FIG. 1; FIG. 6 is an enlarged perspective view of the spreader shown in FIG. 1; FIG. 7 is an enlarged perspective view of the wheel shown in FIG. 1; FIG. 8 is an enlarged perspective view of one of the bolts shown in FIG. 1 used to secure the top spreader to the wheel; FIG. 9 is an enlarged perspective view of the wheel mounting bracket shown in FIG. 1; FIG. 10 is an enlarged perspective view of the shoulder screw shown in FIG. 1; FIG. 11 is an enlarged perspective view of the nut shown in FIG. 1; FIG. 12 is an enlarged perspective view of the pawl shown in FIG. 1; FIG. 13 is an enlarged perspective view of the pin shown in FIG. 1; and FIG. 14 is an enlarged perspective view of the clip shown in FIG. 1 . DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring now to FIGS. 1 through 4, there are shown various views of one embodiment of a device adapted for use in donning a ski boot, said device being constructed according to the teachings of the present invention and being represented generally by reference numeral 11 . Device 11 comprises a pair of identical handles 13 - 1 and 13 - 2 , handles 13 - 1 and 13 - 2 facing away from one another in a mirror image orientation for reasons to become apparent below. Referring now to FIG. 5, handle 13 - 1 is shown by itself; it being understood that the description of handle 13 - 1 to follow applies to handle 13 - 2 as well, albeit in a mirror image orientation. Handle 13 - 1 is an elongated unitary structure, preferably made of a durable metal or a durable molded plastic. Handle 13 - 1 is shaped to include a flat, generally rectangular intermediate portion 14 - 1 , a flat, generally rectangular proximal end 15 - 1 , a flat, trapezoidal intermediate portion 16 - 1 , and a distal end 17 - 1 . Proximal end 15 - 1 is of reduced width as compared to intermediate portion 14 - 1 . Portion 16 - 1 is disposed between intermediate portion 14 - 1 and proximal end 15 - 1 and tapers in width from intermediate portion 14 - 1 to proximal end 15 - 1 . Distal end 17 - 1 is of intermediate width as compared to intermediate portion 14 - 1 and proximal end 15 - 1 . The sides 18 - 1 and 18 - 2 of distal end 17 - 1 are turned upwardly (or, in the case of handle 13 - 2 , downwardly) to facilitate the grasping of distal end 17 - 1 by a user, the remainder of handle 13 - 1 being coplanar. Referring back now to FIGS. 1 through 4, device 11 further comprises a pair of identical spreaders 21 - 1 and 21 - 2 , spreaders 21 - 1 and 21 - 2 facing away from one another in a mirror image orientation for reasons to become apparent below. Referring now to FIG. 6, spreader 21 - 1 is shown by itself, it being understood that the description of spreader 21 - 1 to follow applies to spreader 21 - 2 as well, albeit in a mirror image orientation. Spreader 21 - 1 is an elongated unitary structure, preferably made of a durable metal or a durable molded plastic. Spreader 21 - 1 is shaped to include an elongated, flat, generally rectangular intermediate portion 23 - 1 , an upwardly bent (or, in the case of spreader 21 - 2 , downwardly bent), generally rectangular intermediate portion 25 - 1 extending distally from intermediate portion 23 - 1 , a flat, generally rectangular intermediate portion 27 - 1 extending distally from intermediate portion 25 - 1 and generally parallel to intermediate portion 23 - 1 , a flat, generally rectangular distal end 29 - 1 , distal end 29 - 1 being of reduced width as compared to intermediate portion 27 - 1 , a flat, trapezoidal intermediate portion 31 - 1 , portion 31 - 1 being disposed between intermediate portion 27 - 1 and proximal end 29 - 1 and tapering in width from intermediate portion 27 - 1 to distal end 29 - 1 , and a proximal end 33 - 1 extending proximally from intermediate portion 23 - 1 and curving upwardly (or, in the case of spreader 21 - 2 , downwardly) away therefrom. Referring back now to FIGS. 1 through 4, device 11 further comprises means for coupling together handles 13 - 1 and 13 - 2 and spreaders 21 - 1 and 21 - 2 so that spreaders 21 - 1 and 21 - 2 may be pivoted away from one another in a ratchet-type manner. Said coupling means comprises, in the present embodiment, a wheel 51 and a wheel mounting bracket 61 . Wheel 51 , which is also shown separately in FIG. 7, is a unitary structure preferably made of a durable metal or a durable molded plastic. Wheel 51 is shaped to include a central annular portion 52 and a pair of off-center lateral extensions 53 and 55 , extensions 53 and 55 extending parallel to one another from opposite points around the periphery of annular portion 52 . Annular portion 52 is shaped to include a central transverse opening 54 , the purpose of which will be discussed below, and a plurality of teeth 56 , the purpose of which will also be discussed below, teeth 56 being located below extension 55 along a segment of the periphery of portion 52 . Handle 13 - 2 is fixedly secured (by an adhesive or other suitable means not shown) to the bottom surface of extension 53 , extension 53 having a recessed area 58 so that handle 13 - 2 lies flush with the remainder of extension 53 . Spreader 21 - 1 is fixedly secured by a pair of bolts 59 (one such bolt 59 being shown separately in FIG. 8) to the top surface of extension 55 , extension 55 having a recessed area 60 so that spreader 21 - 1 lies flush with the remainder of extension 55 . As can readily be appreciated, bolts 59 could be replaced with an adhesive or other suitable means. Wheel mounting bracket 61 (which is shown separately in FIG. 9) is an elongated unitary structure, preferably made of a durable metal or durable molded plastic. Bracket 61 is shaped to include a distal portion 63 , a proximal portion 65 and an intermediate portion 67 , intermediate portion 67 interconnecting distal portion 63 and proximal portion 65 . Distal portion 63 and proximal portion 65 extend generally parallel to one another in different planes, with intermediate portion 67 extending downwardly from distal portion 63 to proximal portion 65 . Handle 13 - 1 is fixed (by an adhesive or other suitable means) to the top surface of distal portion 63 , distal portion 63 having a recessed area 69 on its top surface so that handle 13 - 1 lies flush with the remainder of distal portion 63 . Spreader 21 - 2 is fixedly secured by a pair of bolts 59 to the bottom surface of proximal portion 65 . As can readily be appreciated, bolts 59 could be replaced with an adhesive or other suitable means. A longitudinal slot 71 , which extends from distal portion 63 to proximal portion 65 , is provided in bracket 61 , wheel 51 being received in slot 71 . A first pair of transverse openings 73 - 1 and 73 - 2 are formed in bracket 61 , openings 73 - 1 and 73 - 2 communicating with slot 71 and being aligned with opening 54 of wheel 51 . A shoulder screw 75 (shown separately in FIG. 10) is inserted through opening 73 - 1 , opening 54 and opening 73 - 2 , respectively, and is secured in place with a nut 77 (shown separately in FIG. 11 ), screw 75 serving as an axle about which wheel 51 is permitted to rotate. Said coupling means further comprises a pawl 81 (which is shown separately in FIG. 12 ). Pawl 81 , which is an elongated unitary structure, preferably made of a durable metal or durable molded plastic, is shaped to include a generally rectangular lower portion 83 and a hook-shaped upper portion 85 . Pawl 81 extends transversely through longitudinal slot 71 of bracket 61 and is pivotally mounted on a pin 87 (which is shown separately in FIG. 13) so that upper portion 85 of pawl 81 is adapted to engage teeth 56 of annular portion 52 . The aforementioned pivotal mounting of pawl 81 on pin 87 is achieved by insertion of pin 87 through a transverse opening 89 in pawl 81 and through a pair of transverse openings 91 - 1 and 91 - 2 provided in bracket 61 . Said coupling means further comprises resilient means for biasing upper portion 85 of pawl 81 towards teeth 56 of annular portion 52 . In the present embodiment, said biasing means comprises a spring clip 95 . Clip 95 , which is an elongated unitary structure, preferably made of a resilient metal or resilient molded plastic, is shaped to include a proximal portion 97 and a distal portion 99 . Proximal portion 97 , which is generally flat and rectangular in shape, is sandwiched between the top surface of spreader 21 - 2 and the bottom surface of proximal portion 65 and is secured in place by bolts 59 . Distal portion 99 is hook-shaped and is adapted to engage upper portion 85 of pawl 81 in such a manner as to bias upper portion 85 distally towards teeth 56 of annular portion 52 for a ratchet-type action. To use device 11 for the donning of a ski boot, one first rotates device 11 about 90 degrees about its longitudinal axis so that spreaders 21 - 1 and 21 - 2 are positioned side-by-side, as opposed to stacked (as shown in FIGS. 1 through 4 ). One then grasps handles 13 - 1 and 13 - 2 with one's hands and inserts spreaders 21 - 1 and 21 - 2 between the opposing cuff portions of the ski boot to be donned. Next, one pivots handles 13 - 1 and 13 - 2 away from one another until spreaders 21 - 1 and 21 - 2 have correspondingly been pivoted away from one another and have opened the ski boot sufficiently for the wearer's foot to be inserted thereinto. Because of the ratchet-type action of device 11 , even if one ceases to apply a pivoting force to handles 13 - 1 and 13 - 2 , spreaders 21 - 1 and 21 - 2 do not revert to their original orientation until desired. Once the ski boot has been donned and it is desirable to pivot spreaders 21 - 1 and 21 - 2 back towards one another, one simply pivots lower portion 83 of pawl 81 towards annular portion 52 , thereby releasing upper portion 85 of pawl 81 from teeth 56 , and pivots handles 13 - 1 and 13 - 2 back towards one another. As can readily be appreciated, device 11 can be used both by a person wishing to don her own ski boot(s) or by a person wishing to help another person to don one or more ski boots. In addition, it should also be appreciated that device 11 , in addition to being used to don a ski boot, can also be used to open a ski boot to permit its removal from a wearer. Lastly, it should further be appreciated that device 11 is not limited to use in the donning or removal of ski boots and can be used to don or to remove other types of footwear. The embodiments of the present invention recited herein are intended to be merely exemplary and those skilled in the art will be able to make numerous variations and modifications to it without departing from the spirit of the present invention. All such variations and modifications are intended to be within the scope of the present invention as defined by the claims appended hereto.

A device suitable for use in donning a ski boot and a method of using the device to don a ski boot. According to a preferred embodiment, the device comprises a wheel mounting bracket, the wheel mounting bracket comprising a proximal end, a distal end and a longitudinally-extending slot disposed therebetween. A wheel is rotatably mounted within the longitudinally-extending slot and is shaped to include a proximal extension and a distal extension. A first handle is fixed to the distal end of the wheel mounting bracket, and a second handle is fixed to the distal extension of the wheel. A first spreader is fixed to the proximal extension of the wheel, and a second spreader is fixed to the proximal end of the wheel mounting bracket. The wheel is provided with a plurality of teeth along its periphery. A pawl, which is pivotally mounted on the wheel mounting bracket, is engageable with the teeth and is biased towards the teeth by a spring clip.

BACKGROUND OF THE INVENTION The present invention relates to an apparatus for making figures or body exercises in rotation. It also concerns a gripping organ of the type equipping said apparatus. New forms of dances and urban body expression such as hip-hop include rotation figures wherein the male or female dancer turns on himself or herself, by being supported on one hand directly put on a surface or a carpet or a piece of cloth placed on said surface which must be flat. The possible irregularities of the holding surface can cause theses rotation exercises to be particularly tough and sometimes hazardous. Furthermore, the dancers may have their artistic demonstration limited by their physical resistance and their ability to counter the frictions at the interface between their hand and the contact surface. Moreover, the dancers can be led to make figures in rotation by being supported on a part of the body other than the hand, for example, the back, the ass, the head, a knee or a foot. DESCRIPTION OF THE RELATED ART A training apparatus for the swing in golf is already known by document US5810673, comprising a disk coupled in rotation relatively to a basis and provided for receiving a user's foot maintained by a strap. The basis in said apparatus is fixed to a removable ground carpet. SUMMARY OF THE INVENTION The aim of the present invention is to propose an apparatus for making figures or body exercises in rotation, which provides anybody using said apparatus an ability to make figures in rotation in better conditions than those met in the present context of figures in rotation. This aim is met with an apparatus for making figures or body exercises in rotation, comprising: a lower part comprising non-skipping means on an exercise surface, a upper part rotatively mobile relatively to said lower part, and means for rotatively coupling said respectively upper and lower parts. According to the invention, the upper part comprises a gripping piece conformed for receiving a part of a user's body. In a preferred embodiment of an apparatus according to the invention, adapted to receive a user's hand, the gripping piece includes a hollow central part conformed to receive the palm of the user's hand, and a plurality of recesses extending beyond said central part for receiving said user's fingers. Thus there is provided an apparatus which is compact, portable and particularly efficient for figures in rotation. In a variant of the invention, the gripping piece may furthermore include means for braking the mobile upper part. These braking means comprise for example braking control means which can be actuated by a thumb of the user. It is to be noted that models of the apparatus according to the invention can be specifically provide for right-hand or left-hand users, with for example a displacement of the brake from left to right or from right to left depending on the fact that the user is right-hand or left-hand. Preferably, the gripping piece has a structure which is substantially symmetrical for indifferently receiving the user's left hand or right hand. The gripping piece can advantageously include two main protrusions placed on one side and the other side from the central part and three inter-digit protrusions placed substantially in circle arc between the two main protrusions. Numerous techniques can be used for making the gripping piece. For example, as a way of non limitative example, a making process by resin moulding can be used. According to another aspect of the invention, a gripping organ is proposed, of the type equipping the upper part of an apparatus according to the invention, characterized in that it includes a hollow central part conformed to receive the palm of a user's hand, and a plurality of recesses extending beyond said central part for receiving said user's fingers. This gripping organ can be advantageously attached to an accessory able to be actuated or hand-held, such as a projectile launcher, a racket for ball or shuttlecock games, or to a paddle for nautical activity, or to a neutralizing filet launcher. BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be better understood with regards to the following description, in reference to the attached figures: FIG. 1 illustrates a first embodiment example of an apparatus according to the invention; FIG. 2 is a side view of an apparatus of the type featured in FIG. 1 ; FIGS. 3A and 3B respectively feature the insertion of resp. left and right hands of a user in an apparatus according to the invention; FIG. 4 is a perspective view of a second embodiment example of an apparatus according to the invention; FIG. 5 illustrates an example of use for an apparatus according to the invention; and FIGS. 6A , 6 B, 6 C and 6 D feature four specific applications of a gripping organ according to the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS An apparatus 1 according to the invention comprises, with reference to FIGS. 1 and 2 , a lower part 20 equipped with a lower anti-skidding or non-slipping or anti-sliding coating and provided for being put on an exercise surface, a ball-bearing device 30 , and a mobile upper part 10 supporting a gripping piece 100 made by moulding in a material such as resin. This gripping piece 100 comprises a hollow central part 16 conformed to receive in a ergonomic way a user's palm and, in one side and another of said central part, two central protrusions 11 , 15 substantially curved towards the interior on their upper part, and three inter-digit protrusions 12 , 13 , 14 substantially placed in circle arc around said two main protrusions 11 , 15 . The gripping piece constitutes a relatively compact ensemble and can be advantageously decorated particularly in function of its use or for commercial or advertising aims. The mobile upper part 10 can be provided with a mechanical brake (non represented). With reference to FIGS. 3A and 3B , the gripping piece 100 can be designed so as to present a symmetry permitting an ambidexter use of the apparatus according to the invention. Thus, the user can indifferently place his left hand MG or his right hand MD in the gripping piece 100 . In the first embodiment example illustrated by FIGS. 1 and 2 , the lower part has a discoid shape and diameter of the ball bearing 30 is substantially smaller than the diameter of the upper and lower parts. In another embodiment example illustrated by FIG. 4 , the apparatus according to the invention comprises an upper part 110 , a lower part 120 and ball bearing 130 with substantially identical external diameters. With an apparatus according to the invention, a user U dancing hip-hop, inserting his hand into the gripping piece of said apparatus that he has previously placed on an exercise surface S, can then make numerous figures in rotation with exceptional speed conditions. The non-skidding coating 22 placed between the lower part 20 and the ground S ensures the immobility of the apparatus 1 during the exercise. A gripping organ with a structure identical to the gripping piece equipping an apparatus according to the invention can be used for making original devices, when said gripping organ is attached to usually hand-held accessories. The sought main objective is to provide the user with a grip as efficient as possible. Thus, with reference to FIGS. 6A and 6D , several applications can be provided for a same gripping organ 40 made with moulded resin and comprising two main protrusions 411 , 415 and three inter-digit protrusions 412 , 413 , 414 , in such different domains as diving, swimming, defense or security, hunting or ball and shuttlecock games. A first example of application concerns, with reference to FIG. 6A , making nautical ambidexter paddle 6 A including a glove 43 provided with an opening 44 for the wrist and openings for the user's fingers. A second embodiment example concerns, with reference to FIG. 6B , an application of the gripping organ 40 to a projectile launcher 6 B, for example for sharp projectiles, suction cup projectiles, magnet projectiles or projectiles equipped with Velcro®, said launcher being provided for example with a mechanism of bow or arbalest 51 and with a glove 53 . In a third embodiment example illustrated by FIG. 6C , the gripping organ 40 according to the invention is coupled to a device 6 C for launching a filet F used for neutralizing persons or animals, said device being provided with a glove 63 and with a gas-cartridge propulsion mechanism (non represented). The gripping organ according to the invention 40 can also be coupled to a racket 6 D designed for shuttlecock V or ball B games and provided with a sieve 71 and with a glove 73 inserted in the gripping organ. It is to be noted that in the above-described application examples, other embodiments which don't include a glove can be contemplated. Of course, various embodiments are possible. Particularly, the gripping piece can be adapted to receive a part of a body other than a hand, for example, a foot, a knee, an elbow, the buttocks or the head of a user. This can be made possible by adding on a existing gripping piece an adaptation piece specifically conformed to receive this other body part.

An apparatus ( 1 ) for making figures or body exercises in rotation, includes: a lower part ( 20 ) having non-skipping elements ( 22 ) on an exercise surface (S); a mobile upper part ( 10 ) rotating relatively to the lower part ( 20 ), and elements ( 30 ) for coupling in rotation the respectively upper and lower parts ( 10, 20 ). The upper part ( 10 ) comprises a gripping piece ( 100 ) conformed to receive a part (M) of a user's (U) body.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable CROSS-REFERENCE TO RELATED APPLICATIONS Not Applicable BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to medical devices and more specifically to disposable self-retaining laryngoscopes useful for orally intubating a patient with an endotracheal tube. 2. Background of the Prior Art Laryngoscopes have long been used to open the mouth and airway to allow examination of the larynx and to assist in oral intubation of the compromised airway with an endotracheal tube. To better understand the present invention, it is useful to review the prior art and the current state of the art in laryngoscopes. It is also necessary to understand why laryngoscope aided intubation is clinically important; why it is frequently difficult or impossible to accomplish with the prior art and to briefly discuss the consequences to the patient that can be caused by problems resulting from the use of prior art laryngoscopes. U.S. Pat. No. 4,570,614, which issued to Bauman on Feb. 18, 1986, teaches a laryngoscope with a single disposable nonmetallic blade, a light source disposed within the handle and a light conductor disposed adjacent to and held by the blade. Typical of the prior art, this apparatus requires two hands to operate, and perhaps even two caregivers, if the patient's mouth and head must be stabilized. Lacy (U.S. Pat. No. 5,355,870) and Bar-Or et. al. (U.S. Pat. No. 5,702,351) also teach disposable plastic single blades used in combination with a light source in a laryngoscope. U.S. Pat. No. 4,573,451, which issued to Bauman on Mar. 4, 1986, teaches a laryngoscope blade which has a tip that is capable being bent or flexed in the direction of the handle of the laryngoscope. This allows the patient's epiglottis to be lifted to expose the patient's larynx. This is a single blade instrument. It is provided with a ratchet lock to maintain the bend in the tip. This instrument can bend in only one direction, to lift the epiglottis. Locking the laryngoscope blade in an operable position is also shown in U.S. Pat. No. 5,651,760, but this lock/unlock mechanism functions to enable the instrument to be compact when it is not in use. U.S. Pat. No. 5,036,835, which issued to Filli on Aug. 6, 1991, teaches a slideably adjustable spatula portion in the laryngoscope blade. The function of this spatula is to act as a tongue depressor to facilitate inspection of the pharynx and larynx, or the insertion of an anesthetic breathing tube. This apparatus uses a single blade with a sliding part, which does not lock in position. U.S. Pat. No. 5,070,859, which issued to Waldvogel on Dec. 10, 1991, teaches a laryngoscope that incorporates a dynamometer in order to measure the force used by the caregiver to examine the patient. This invention is an attempt to avoid trauma to the patient that can occur using prior art apparatus. U.S. Pat. No. 4,517,964, which issued to Upsher on May 21, 1985, teaches a dual bladed laryngoscope, wherein one conventional blade carries its own light source and the second blade is a light guide for a second light source in the handle of the instrument. The closest prior art known to the present inventor is U.S. Pat. No. 5,498,231, which issued to Franicevic on Mar. 12, 1996. This apparatus is the current state of the art in the field of laryngoscopes. Franicevic teaches a reusable laryngoscope for use "in difficult intubation due to malformation of the jaws, tongue, pharynx, larynx or neck as a result of trauma, edema, inflammation or congenial anomalies." This laryngoscope has a hollow body terminating at its distal end in a pair of opposed blades that can be spread apart by the caregiver. An endotracheal tube slides through the hollow tube in the center of the instrument. Light conducting means are provided to illuminate the larynx. The device includes a fiberoptic optical system for inspecting the larynx during intubation. Franicevic is an improvement on the `bendable tip` of Bauman, cited above. The single distal spreading of the `beak` taught by Franicevic allows some lifting of the soft tissue, but it does nothing to open the mouth or depress the tongue. Franicevic teaches a bias spring to keep the distal blades closed when they are not positively spread apart by the caregiver. This apparatus is not locking or self-retaining in the airway. It also is not disposable and its complex mechanism makes it difficult to adequately sterilize. Intubation using prior art laryngoscopes requires at least two hands. Four hands may be needed to hold the head and mouth of the patient, operate the laryngoscope and intubate the patient. Prior art instruments are either reusable; and thus present risk of disease to the caregiver; or they use disposable single plastic blades, which become covered with blood and fail to light the airway. This can make it difficult or impossible to intubate the patient, even if the procedure is done in a hospital and the airway is normal. These problems become much more severe in the field; during emergency transportation of the patient; or when attempting to intubate an abnormal or damaged airway. When the prior art fails, effects on the patient are often severe. Respiratory related mishaps are a major source of patient morbidity and mortality. Should a difficult airway problem arise, approximately 40% will result in death, 20% in brain damage and 40% in high morbidity trauma. The incidence of difficulty in intubation is said to be between 1.2 and 2.5%, about 1 in 65 patients. This is a major medical problem, especially for the practitioner of emergency medicine. The number of different variations of laryngoscope found in the prior art is a good indication that many experts skilled in this art have tried to find solutions to these problems. The causes of difficulty in endotracheal intubation are either congenital or acquired. Congenital causes include conditions such as: Pierre Robin syndrome. Cystic hygroma. Treacher-Collins syndrome. Gargoylism. Achondroplasia. Marfan's syndrome. Numerous anatomical features have been identified that make endotracheal intubation difficult, especially in trauma patient who must be treated promptly in the field or during transport to a hospital. These include: excessive weight. short muscular neck and a full set of teeth. protruding incisors. long high arched palate with long narrow mouth. receding mandible. large swellings in the neck, mouth or upper chest. decreased distance between the occiput and the spinous process of C.1. increase in posterior depth of the mandible. increase in alveolar--mental distance requiring wide opening of the mandible. Endotracheal intubation using prior art laryngoscopes may also be difficult or impossible because of acute swelling in the neck due to trauma or bleeding. Intubation may be difficult if flexion of the neck is contraindicated because of cervical spine injury or severe rheumatoid arthritis. The following categories of patients require a definitively secured airway: 1. Apnoea 2. <9 or sustained seizure activity. 3. Unstable mid-face trauma. 4. Airway injuries. 5. Large flail segment or respiratory failure. 6. High aspiration risk. 7. Inability to otherwise maintain an airway or oxygenation. The urgency of airway intubation is the most important factor in planning which technique of securing the airway is the safest and most appropriate. The caregiver must evaluate and assess the risk of further cord injury given head and neck movement, the degree of cooperation from the patient, anatomy and trauma to the airway and the caregiver's own expertise in each technique. Initially the airway should be cleared of debris, blood and secretions. It should be opened using the `chin lift` or `jaw thrust` maneuvers. The `sniffing the morning air` position for standard tracheal intubation flexes the lower cervical spine and extends the occiput on the atlas. An oral (Guedel) or nasopharyngeal airway may be necessary to maintain patency until a definitive airway is secured. Insertion of an airway produces minimal disturbance to the cervical spine. Bag and mask ventilation also produces a significant degree of movement at zones of instability. The ATLS recommends a nasotracheal tube in the spontaneously breathing patient, and orotracheal intubation in the apnoeic patient. MANUAL in-line axial stabilization must be maintained throughout. The hard collar may interfere with intubation efforts and the front part may be removed to facilitate intubation as long as manual stabilization is in effect. Blind nasal intubation is successful in 90% of patients but requires multiple attempts in up to 90% of these. Nasotracheal intubation is (relatively) contraindicated in patients with potential basillar skull fracture or unstable mid-face injuries. In addition, it may produce hemorrhage in the airway, making other airway manipulations difficult or impossible. Orotracheal intubation is generally accepted as the more usual method for securing the airway in the trauma patient. It is the fastest and surest method of intubating the trachea. At Shock Trauma in Baltimore, Md. (Grande C. M., Barton C. R., Stene J. K. "Appropriate Techniques for Airway Management of Emergency Patients with Suspected Spinal Cord Injury." Anesth Analg 1988;67:714-715) more than 3000 patients were intubated orally with a modified rapid sequence induction technique with pre-oxygenation and cricoid pressure. Ten percent of these patients were found to have cervical spine injury and none deteriorated neurologically following intubation. Awake intubation is also a feasible option and is favored by some practitioners. It may be performed via the nasotracheal route, direct oral laryngoscopy or by fibreoptic technique. Successful fibreoptic tracheal intubation requires a cooperative patient, a secretion and blood free airway, a pharynx unrestricted by oedema and adequate supraglottic and infraglottic anesthesia. Such ideal conditions often do not exist, and local anaesthetic preparation of the airway is time consuming and might increase the risk of aspiration even if done in a proper hospital. Failed or difficult intubation is always a problem. Some nontramatic causes are: A. difficult blade insertion in the obese patient B. absence of any landmarks C. ineffective lighting D. inability to pass endotracheal tube Complications of direct laryngoscopy and intubation as taught by the prior art can be severe and can include: A. hypoxia B. esophageal intubation C. glottic and epiglottic edema D. vocal cord injury E. tracheal perforation F. dental trauma G. endobronchial intubation H. pulmonary aspiration I. laryngospasm J. bronchospasm K. cervical spine injury L. increased intracranial pressure M. increased intraoculary pressure N. pulmonary edema In addition to these risks to the patient, most prior art laryngoscopes are reused. This is always true of complex designs, such as the laryngoscope taught by Franicevic, cited above. Such prior art laryngoscopes can present a risk of disease to the caregiver because they are often not possible to completely sterilize them after use. In most cases they are even not sterilized, but just washed by hand. BRIEF SUMMARY OF THE INVENTION The invention is a self-retaining disposable laryngoscope having dual light conductive blades that open and lock apart laterally and/or radially. The invention has two curved blades: a tongue blade and a palate blade. These two blades may be separated and locked apart by a ratchet mechanism in the instrument's handle while they remain parallel. This provides a bite block, pushes down the tongue, and makes the invention self-retaining in the airway. The palate blade may be rotated about an axis in the handle of the instrument and locked in position by a ratchet mechanism to spread the distal ends of the blades. This lifts the tongue and epiglottis and opens the airway. Both plastic blades are light conductors for a source of light located in the handle. Light from both blades assures that one blade being covered with blood will not prevent adequate light from illuminating the airway. The present invention may be operated with one hand initially and then locked, freeing both hands because the blades lock into position in the airway when they are separated and/or rotated. It is therefore a principle object of the present invention to provide a dual blade laryngoscope whose blades can lock open both laterally and radially to allow endotracheal intubation of the difficult airway. A further object of the present invention is to provide a laryngoscope capable of simultaneously opening the mouth, lifting the tongue and lifting the epiglottis, whereby it is self-retaining in the airway. Another object of the present invention is to provide a laryngoscope that adequately lights the airway during intubation even if one blade of the instrument is obscured by blood or foreign material. A further object of the present invention is to provide a laryngoscope that provides a bite block to prevent dental trauma, and to protect integrity of the airway and personnel. Yet a further object of the present invention is to provide a laryngoscope that is inexpensive and disposable. An important object of the present invention is to provide a laryngoscope that may be operated with one hand and by caregivers not trained as experts at endotracheal intubation BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS FIG. 1 shows a side view of the present invention; FIG. 2 is a side view of the palate blade of the present invention; FIG. 3 is a top view of the palate blade of the present invention; FIG. 4 is a side view of the tongue blade of the present invention; FIG. 5 is a front view of the tongue blade of the present invention; FIG. 6 is a top view of the tongue blade of the present invention; FIG. 7 is a section view of the tongue blade taken along section lines 7--7 of FIG. 6; FIG. 8 is a side view of the slide/rotary ratchet mechanism of the present invention; FIG. 9 is a rear view of the slide/rotary ratchet mechanism of the present invention; FIG. 10 is a section view taken along section lines 10--10 of FIG. 8; and FIG. 11 is a table showing typical dimensions of the drawings shown in FIGS. 1-10 for small, medium and large laryngoscopes. DETAILED DESCRIPTION OF THE INVENTION FIGS. 1 to FIG. 10, inclusive, show preferred angles and dimensions of the best embodiment of the present invention known to the inventor. In some cases distances are marked with letters of the alphabet rather than numeric values. This is done because laryngoscopes must be made in several sizes, for children and adults, as well as to take into account the normal size variations in patients. The values for these dimensions are given in the table shown in FIG. 11. It is the intention of the inventor to thereby give a sufficient disclosure of the present invention to allow any person skilled in the art of making laryngoscopes the ability to make and use the present invention without undue experimentation. FIG. 1 shows a side view of the preferred embodiment of the present invention. Structurally, In FIG. 1, laryngoscope 101 has a curved palate blade 103 having a palate blade tip 109. Laryngoscope 101 also has a tongue blade 105 having a tongue blade tip 107. Blades 103 and 105 are curved in a manner well known to those skilled in the art and are roughly parallel to each other. Palate blade 103 has a rotation axis 111 and a lever portion 113. Lever portion 113 is adapted to operable receive ratchet member 115 of ratchet mechanism 117. Ratchet mechanism 117 is part of lateral/radial ratchet assembly 133. The lower part 135 of assembly 133 has a hole for receiving axis 111. Tongue blade 105 has an upright portion 119 that has a ratchet mechanism 121. Ratchet 121 engages tip 125 of rocker lever 123. Lever 123 is attached to assembly 133 by semi-rigid shaft 127. Lever 123 has a lower part 129 that is equipped with finger knurls 131. A battery, switch and light source, not shown, are disposed within upright member 119. Blades 103 and 105 are made by injection molding of any plastic that is suitable for medical devices and capable of conducting light along the length of the blades. Assembly 133 is made by injection molding from any plastic suitable for medical use that is strong and resilient enough to allow the ratchet mechanisms to operate reliably. Functionally, laryngoscope 101 operates as follows. The patient's head is stabilized. The mouth is opened. Blades 103 and 105 are proximate each other and are placed into the airway. With the thumb of the one hand holding the laryngoscope, the caregiver pushes rocker lever 123 and slides palate blade 103 away from tongue blade 105. As this is done, the end 125 of lever 123 engages ratchet 121 of the upright part 119 of blade 105. The result is that blades 103 and 105 separate and lock apart while remaining in parallel. This depresses the tongue and elevates the palate. The patient's mouth is opened wide and locked open by the laryngoscope, which also acts as a bite block. The patient's airway is illuminated by light from both blades of the invention. Natural tension of the patient's jaw and mouth makes the invention self-retaining in the patient's airway. It remains in place without requiring either the hands or attention of the caregiver until lever 129 is pressed, which releases lever 125 from ratchet mechanism 121 and allows blades 103 to return to its original position adjacent to blade 105. When laryngoscope 101 has its two blades 103 and 105 laterally separated and locked by the ratchet mechanism of the invention in the patient's airway, the entire attention of the caregiver can be directed to the work of intubation. If necessary, the caregiver may press lever section 113 of palate blade 103 towards the handle of the invention using the thumb of the hand holding the laryngoscope. When lever section 133 is moved toward assembly 113, it rotates palate blade 103 about axis 111 and causes palate blade tip 109 to separate at its distal end from the tip 107 of tongue blade 105. As this happens, ratchet member 115 of lever 113 engages ratchet mechanism 117 of assembly 133 to lock the blade tips apart. This action at the blade tips lifts the soft tissue and exposes the larynx. When this is accomplished, the caregiver may leave the invention locked in position and concentrate entirely on intubating the patient. Blade tips 107 and 109 will remained locked in the open position until the end of ratchet mechanism 118 is depressed allowing palate blade 103 to return to its original position. FIG. 2 shows a side view of the palate blade of the preferred embodiment of the present invention. In FIG. 2, palate blade 201 has a projecting axis 202, a palate portion 211 having curved end sections 213 and 215. Opposite axis 202 from end 215, is lever 203 having a ratchet engagement part 205 with a ratchet engagement tooth 207. The angles and distances shown on in FIG. 2 refer to the table in FIG. 11. FIG. 3 shows a top view of the palate blade of the preferred embodiment of the present invention. In FIG. 3 the palate blade's palate section 311 is shown with ends 313 and 315 and palate blade tip 309. Opposite axis 302 from section 311, lever section 303 is shown with opening 304. Opening 304 accommodates the upright section of the tongue blade and the lateral and radial ratchet assembly, described in connection with FIG. 1 above. The angles and distances shown in FIG. 3 are referenced to the table of sizes disclosed in FIG. 11. FIG. 4 shows a side view of the tongue blade of the preferred embodiment of the present invention. In FIG. 4, tongue blade assembly 400 has a curved transparent tongue blade having a tongue blade tip 409. Blade assembly 400 also has an upright section 401 having a base member 405 and a ratchet assembly 403 on its side opposite blade. The distances and angles shown in FIG. 4 refer to the table in FIG. 11. Inside the upright portion 401 of tongue blade assembly 400 is a light source, not shown, for illuminating the transparent light conducting blades of the present invention. FIG. 5 is a front view of the tongue blade assembly of the preferred embodiment of the present invention. In FIG. 5, upright section 501 is shown in relation to the curved portion of blade 503, which has an end 509. The lower portion 505 of the assembly is also shown. The sizes and distances shown in FIG. 5 refer to the table in FIG. 11. FIG. 6 is a top view of the tongue blade of the preferred embodiment of the present invention. In FIG. 6, upright section 601 is shown attached to blade 607, which has a tapered tip section 609. Ratchet mechanism 603 is shown on the side of blade upright section 601 that is opposite blade section 607. FIG. 7 is a cross section of the tongue blade of the preferred embodiment of the present invention taken along section lines 7--7 of FIG. 6. FIG. 7 is presented to show the curvature of the tongue blade. FIG. 8 is a side view of the slide/rotary ratchet mechanism of the present invention. In FIG. 8, mechanism 801 has a lower rounded portion 803 having a hole 805. Mechanism 801 also has an upper engaging porting 807. Simi-rigid member 813 mounts lateral ratchet lever 815 to engaging portion 807. Lever 815 has a release end 817 having knurls 819. About the middle of mechanism 801 is a curved projecting member 809 having a ratchet mechanism 811 on its upper side. This is the most complex molded part of the present invention. Care must be taken to ensure that the structural elements used for engaging the ratchet locks for the lateral and radial separation of the blades of the present invention have the proper degree of flexibility. FIG. 9 is a rear view of the slide/rotary ratchet mechanism of the present invention. In FIG. 9 equivalent numbers beginning with `9` indicate equivalent structures to FIG. 8's numbers beginning with `8`. FIG. 10 is a cross section view taken along section lines 10--10 on the engaging section 808 of FIG. 8. In FIG. 10, engaging section 1001 has projections 1003 that define a channel 1005. A similar channel is defined on the opposite side of the section. FIG. 11 is a table showing the dimensions of the proffered embodiment of the present invention for small, medium and large versions of the invention. In this detailed specification the inventor has disclosed in the best embodiment of his invention known to him at the time he made application for letters patent. Many variations of size, shape and details of structure could be made by persons skilled in the art of making medical devices that would still be this invention. For example, the ratchet locking mechanism shown in this specification could be replaced by a set of screw threads or a friction locking mechanism to hold the blades in their proper position. This detailed embodiment of the present invention should therefore be read and understood as illustrating, but not limiting, the scope of my invention. The invention should be limited only by the following claims.

The invention is a self-retaining disposable laryngoscope having dual light conductive blades that open and lock apart laterally and/or radially. The invention has two curved blades: a tongue blade and a palate blade. These two blades may be separated and locked apart by a ratchet mechanism in the instrument's handle while they remain parallel. This provides a bite block, pushes down the tongue, and makes the invention self-retaining in the airway. The palate blade may be rotated about an axis in the handle of the instrument and locked in position by a ratchet mechanism to spread the distal ends of the blades. This lifts the palate and epiglottis and opens the airway.

RELATED PATENT FILINGS [0001] Method and System for Consciously Synchronizing the Breathing Cycle with the Natural Heart Rate Cycle (10/699,025), System and Method for Synchronizing the Heart Rate Variability Cycle With The Breathing Cycle (Feb. 19, 2004), Method of Presenting Audible and Visual Cues for Synchronizing the Breathing Cycle With An External Timing Reference for Purposes of Synchronizing The Heart Rate Variability Cycle With The Breathing Cycle (Mar. 15, 2004), Method and System Providing A Fundamental Musical Interval for Heart Rate Variability Synchronization (Mar. 23, 2004), Method and System of Respiratory Therapy Employing Heart Rate Variability Coherence (10/814,035). FIELD OF THE INVENTION [0002] The present invention relates to the field of human health and in particular to what is a potentially a new field of therapy with the specific purpose of preventing or reducing sympathetic predominance, “sympathetic predominance” referring to over-activation of the sympathetic branch of the autonomic nervous system and the relative under activity of the parasympathetic branch, and positively modifying its resultant conditions, one of which is proposed to be “hypertension”. [0003] The reason that it is a potentially new field of therapy is that, while it involves “breathing” it is not “respiratory therapy” in the traditional sense, for it concerns itself with the matter of blood gases only indirectly. Neither is it a present concern of “physical therapy”. The present invention, defines a specific form of therapy wherein breathing is employed in order to realize fundamental changes in neuro-physiological functioning, specifically, positive modification of autonomic nervous system function, or more specifically, the correction of sympathetic nervous system predominance, one of its resultant conditions being “hypertension”. [0004] Consequently, for purposes of this patent, said therapy will be referred to as “breathing therapy”. BACKGROUND OF THE INVENTION [0005] Hypertension or “high blood pressure” is presently defined as “a medical condition in which constricted arterial blood vessels increase the resistance to blood flow, causing the blood to exert excessive pressure against vessel walls”. 1 It is also recognized that “two factors determine blood pressure: the amount of blood the heart pumps and the diameter of the arteries receiving blood from the heart. When the arteries narrow, they increase the resistance to blood flow. The heart works harder to pump more blood to make sure the same amount of blood circulates to all the body tissues. The more blood the heart pumps and the smaller the arteries, the higher the blood pressure. As a measure of overall heart function doctors use cardiac output, the amount of blood pumped by each ventricle in one minute. Cardiac output is equal to the heart rate multiplied by the stroke volume, the amount of blood pumped by a ventricle with each beat. Stroke volume, in turn, depends on several factors: the rate at which blood returns to the heart through the veins, how vigorously the heart contracts, and the pressure of blood in the arteries, which affects how hard the heart must work to propel blood into them. An increase in either heart rate or stroke volume—or both—will increase cardiac output.” 1 In summary, the higher the cardiac output, the higher the blood pressure. ( 1 Microsoft Encarta, Microsoft Corporation) [0006] Relative to central nervous system functioning, hypertension is the state wherein the sympathetic (activating) function has persistent predominance over the parasympathetic (deactivating) function. It is sympathetic action that elicits accelerated heartbeat rate and contractile vigor. In theory, sympathetic action also governs blood vessel constriction; these factors combined, resulting in the state of hypertension. [0007] Hypertension represents a huge health care challenge where large percentages of the adult, and now adolescent population, are identified as being hypertensive. Greater than 25% of the American population is estimated to be affected by hypertension. Hypertension is known to be strongly related to cardiopulmonary integrity, stroke, and internal organ health. Today, the treatment of hypertension is approached through the application of pharmaceuticals, diet, fitness, and lifestyle modification. “If these (lifestyle modification) methods do not correct hypertension, a physician may prescribe medications known as antihypertensives. Diuretics are antihypertensives that promote excess salt and water excretion, reducing the amount of fluid in the bloodstream and relieving pressure on blood vessel walls. Beta blockers reduce heart rate and the amount of blood the heart pumps. ACE inhibitors prevent the narrowing of blood vessel walls to control blood pressure. Calcium channel blockers slow heart rate and relax blood vessels.” 1 While these drugs are effective for some, they are non-effective for others, also often presenting negative side effects, sometimes severe. For many people, their hypertension continues, ultimately reducing their well being, increasing their risk of serious disease, and reducing their longevity. ( 1 Microsoft Encarta, Microsoft Corporation) [0008] The cost of hypertension including human costs, healthcare system costs, and pharmaceuticals runs into the $B per annum in the United States alone. It is generally assumed that hypertension is a necessary condition of modern life. [0009] Research on which this patent is based, strongly indicates that a root cause (if not the root cause) of hypertension is in fact “inadequate breathing”. Inadequate breathing results in sympathetic nervous system predominance with a like withdrawal of parasympathetic action. FIG. 1 depicts the heart rate variability patterns and average heartbeat rates of a resting test subject breathing at 4 different breathing rates: 5 breaths per minute A, 7.5 breaths per minute B, 15 breaths per minute C, and 30 breaths per minute D. As can be seen: 1) Heart rate variability (amplitude) shrinks as breathing frequency increases. 2) The average heartbeat rate shifts upward as breathing frequency increases. These measurements are taken while the subject is at rest. This behavior is consistent with the behavior of the cardiopulmonary system during exercise, i.e., during exercise, the cardiopulmonary system accelerates to address the demand for increased oxygen, yet in the state of rest there is no increasing oxygen demand, except for a slight increase as a consequence of increased diaphragmatic activity. Why and how the average heartbeat rate increases with increased breathing frequency while in the resting state is not fully understood. 3) Contrasting 5 breaths per minute with 30 breaths per minute, 30 breaths per minute results in the heart working much faster on a continuous basis than 5 breaths per minute. To be clear, at 30 breaths per minute, the heartbeat rate varies between ˜91 and ˜93 BPM, never slowing down below ˜91 BPM. At 5 breaths per minute the heartbeat rate varies between ˜60 and 94 BPM, 50% of the time it is below 77 BPM and 88% of the time it is below 91 BPM. Consequently, if we compare these two “linearly”, relative to 30 breaths per minute, 5 breaths per minute allows the heart rest for 88% of the time, i.e. for 88% of the time the heartbeat rate is less than ˜91 BPM. [0013] Per the prior discussion, heartbeat rate is one factor that directly affects blood pressure, such that, as the heartbeat rate increases, blood pressure increases. Consequently, it clearly follows that faster shallower breathing, even while at rest, increases heartbeat rate and blood pressure and slower deeper breathing reduces heartbeat rate and blood pressure. [0014] Most people breathe at a rate of 10-15 breaths per minute. 2 While 30 breaths per minute was used in the prior example for contrast, the same basic relationship holds true for the range 10-15 breaths per minute. If we compare 5 breaths per minute with 15 breaths per minute, respective average heartbeat rates are 77 vs. 86, with heart rate variabilities ranging from 60-94 vs. 84-88 BPM. Comparing these two “linearly”, relative to 15 breaths per minute, 5 breaths per minute allows the heart rest for 70% of the time, i.e. for 70% of the time the heartbeat rate is less than ˜84 BPM. [0015] The cardiopulmonary system of a human adult in a resting or semi-active state aspires to a specific resting frequency of 0.085 cycles per second or 5 cycles in ˜1 minute. At this rate, the cardio pulmonary system is optimally effective and efficient heart rate variability being of maximal amplitude, periodicity, and coherence, i.e. free of distortion. The heartbeat rate at this breathing rhythm, in this case 77 beats per minute, defines the autonomic baseline above which the sympathetic function is predominant and below which the parasympathetic function is predominant Referring once again to FIG. 1 , this breathing frequency is characterized by the line titled “fundamental quiescent rhythm”. Again, for this test subject, breathing at this rate, yields an average heartbeat rate of 77 beats per minute, 77 BPM being the baseline between sympathetic and parasympathetic emphasis. In other words, relative to this test subject, an instantaneous heartbeat rate above 77 BPM represents sympathetic (activating) emphasis and an instantaneous heartbeat rate below 77 BPM represents parasympathetic (deactivating) emphasis. Consequently, as the average heartbeat rate shifts upward (above 77 BPM) as a consequence of breathing at a pace exceeding ˜5 breaths per minute, the autonomic nervous system shifts from the state of balance, sympathetic and parasympathetic equality, toward sympathetic predominance. The further it shifts in the positive direction, the stronger the sympathetic dominance. For this subject, the relationship between the average heartbeat and breathing rate is quite linear above 7.5 breaths per minute, varying at 3 beats per 7.5 breaths as detailed in FIG. 2 . [0016] FIG. 2 makes clear the fact that while average heartbeat rate varies only slightly across a relatively wide range of breathing frequencies, heart rate variability varies widely. [0017] The inventor asserts that breathing at a rate above 5 breaths in 58.8 seconds, while at rest, if persistent, results in the pathological condition of “sympathetic predominance” or sympathetic over activation and parasympathetic under activation. Consequently, that the typical breathing rate of 10-15 breaths per minute produces the condition of sympathetic over activation in much of the population predisposing said population to a myriad of maladies, one of which is the class of symptoms commonly referred to as “hypertension”. [0018] In summary, it is the premise of this patent, that: 1) The average heartbeat rate at the fundamental quiescent rhythm of 1 complete breathing cycle in 11.76 seconds or 5 complete breathing cycles in 58.8 seconds defines the baseline between sympathetic and parasympathetic emphasis on an individual basis. This is generally true for the adult population. 2) A second premise is that breathing at a rate faster than the fundamental quiescent rhythm of 1 complete cycle in 11.76 seconds directly results in the state of autonomic imbalance, specifically sympathetic predominance or over activation, and a corresponding parasympathetic withdrawal or under activation. This is also generally true for the adult population. 3) A third premise is that upwardly shifting average heartbeat rate and shrinking heart rate variability coincident with increasing breathing frequency, is an accurate indicator of sympathetic over emphasis, which, if persistent, results in a pathological neuro-physiological status, specifically including “hypertension”. 4) A fourth premise is that autonomic balance can be regained by breathing at slower rates, the ideal rate being the fundamental quiescent rhythm of 1 complete cycle in 11.76 seconds or 5 complete cycles in 58.8 seconds. Breathing at rates below ˜5 breaths per minute has proven to be non-productive, resulting in distortion of the heart rate variability pattern. 5) A fifth and final premise is that sympathetic predominance can averted and its affects avoided by adopting a “normal” breathing frequency of 1 complete cycle in 11.76 seconds or 5 cycles in 58.8 seconds. SUMMARY OF THE INVENTION [0024] The invention specifies a system and method for leading a person suffering from “sympathetic predominance”, a specific symptom of which is “hypertension”, to breathe according to a certain pattern for the express purpose of positively altering the condition of sympathetic predominance (over activation), having the effect of bringing the autonomic nervous system into the state of balance, with consequent reductions in “tenseness”, blood pressure, muscular tightness, and emotional strain, as well as the alleviation of the myriad of subtle neuro-physiological consequences resulting from sympathetic predominance potentially including headaches, anxiety, sleep disorders, allergies, and other maladies that have yet to be attributed to this condition, thus leading to a general improvement in health, well being, and homeostasis. [0025] An instructive method is specified for both therapy practitioners and care recipients in the application of the preferred embodiments of the present invention to the general condition of sympathetic predominance as is elicited by inadequate breathing, and the specific symptomology commonly referred to as “hypertension”. [0026] This patent represents new art relative to the application of “breathing therapy” to the resolution of the general condition of autonomic nervous system imbalance, specifically the condition of sympathetic predominance or over activation and parasympathetic under activation. A general definition is provided relative to the objective “ideal” state of autonomic balance and how this state is achieved and maintained. Specific focus is provided as to how to correct the state of predominance, once identified. Application of the present invention to the symptoms commonly referred to as “hypertension” is described. As the correction of sympathetic predominance via breathing therapy is a nascent field of investigation, it is anticipated that it will find broad application in the alleviation of numerous maladies that are rooted in sympathetic over activation. Those skilled in the art will recognize that those applications are considered within the scope of the concepts disclosed herein and the claims that follow. Application of the present invention may be employed alone or in combination with medication as is deemed appropriate by the attending health care professional. BRIEF DESCRIPTION OF THE DRAWING FIGURES [0027] The accompanying drawing figures incorporated in and forming a part of this specification illustrate several aspects of the invention and together with the description serve to explain the principles of the invention. [0028] FIG. 1 presents a graphical model of 4 breathing rates, presenting resultant average heartbeat rates and heart rate variability patterns. [0029] FIG. 2 presents a graph depicting the 4 breathing rates of FIG. 1 presented along a linear scale. Heart rate variability ranges at each of the 4 breathing rates are also depicted. [0030] FIG. 3 presents a block diagram of one preferred embodiment of the present invention for relatively stationary applications. [0031] FIG. 4 presents a table detailing breathing cycle programmability steps and associated breathing intervals. Track numbers for compact disk or digital video disk application are also specified. [0032] FIG. 5 presents a second preferred embodiment wherein an “integrated training and monitoring system” is provided. [0033] FIG. 6 describes programmability aspects of the integrated training and monitoring system of FIG. 5 . [0034] FIG. 7 provides a logical description of the basic control systems of preferred embodiments as described in FIGS. 3 and 5 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0035] The present invention provides a method and system by which “breathing therapy” may be optimally applied to a conscious recipient or recipients by facilitating the slowing of the recipients resting breathing rate to the ultimate rhythm of 1 cycle in 11.76 seconds, inhalation persisting for 5.88 seconds and exhalation persisting for 5.88 seconds. Additionally, several sub-methods and sub-systems are defined providing alternative means of presenting the recipient with breathing cues and for monitoring the breathing rate of the recipient in both stationary and mobile (normal walk of life) settings. [0036] The care recipient is presented an audio, visual, or audio-visual representation of the objective breathing cycle with a gradually increasing interval (decreasing frequency) to which the recipient consciously synchronizes their breathing cycle. In this way, a person suffering from chronic sympathetic predominance might start out with a pathological breathing frequency of 20 cycles per second, 20 cycles per second being used for example only, and over some time of training, gradually lower their “normal” breathing frequency to 15, to 10, and eventually to 5 cycles in approximately 1 minute. Instruments for monitoring the breathing cycle are applied for “feedback” purposes in the early stages of training and for ongoing monitoring relative to acute scenarios. Relative to the treatment of hypertension, the subject's blood pressure is gauged regularly as they progress from a higher breathing frequency to a relatively lower frequency over some duration of training. [0037] A stepwise approach is specified because it is typically impractical for a person suffering from chronic sympathetic predominance to radically alter their breathing pattern all at once. A primary reason for this is that in order to breathe slower, one must also breathe deeper requiring conscious coordination and control. Breathing deeper requires the employment of the diaphragm and intercostal muscles. As is true with learning any new physical skill, it takes time to learn to coordinate the movement as well as tonify and build the respective muscle groups that are involved. This is especially true of the diaphragm because it is a relatively large muscle of which most people tend to have little awareness. [0038] Once the subject reaches either their the target breathing frequency of ˜5 cycles in 1 minute, or in the case of application to hypertension, their target blood pressure, they may shift to a maintenance regimen wherein the invention is employed for ongoing reinforcement of the desired breathing frequency. [0039] FIG. 3 , specifies the preferred embodiment of the present invention in the stationary setting as might take place in a home, office, or health care setting. [0040] While a specific instructive method is specified later, a brief discussion of the method is required here for context. Care recipient A, is positioned such that they are able to see or hear audible, visual, or audiovisual display device B. Optionally, care recipient A or a health care practitioner, attaches breathing rate and/or blood pressure monitoring apparatus C to care recipient A. Care recipient A, is able to perceive the status of their breathing rate and blood pressure as monitored by apparatus C. Upon assessing the present breathing status of care recipient A, care recipient A or alternatively, a health care practitioner, turns on breathing cycle timing generator D and selects the optimal breathing interval at which care recipient A is to practice breathing. This interval is generated by breathing cycle timing generator D and is displayed on display device B, according to the preferred mode of operation and or the ability of the given display device to support multiple forms of media. In its simplest form display device may be a speaker or set of headphones, in it's most complex form a personal computer. [0041] FIG. 4 provides a table defining the breathing intervals supported by breathing cycle timing generator of FIG. 3 -D, ranging from ˜5 breaths per minute to 30 breaths per minute in 1 breath per minute intervals. This is depicted by row A of the table. If it is determined that the care recipient present interval is 20 breaths per minute, a setting of “18” might be selected for practice. Once care recipient A is able to breathe comfortably at “18” breaths per minute, a lower setting, for example “15” breaths per minute might be selected. The rate at which a given care recipient is able to progress toward the optimal breathing rate of 5 cycles in ˜1 minute has to do with their level of comfort, health, fitness, and extent of practice. FIG. 3 , row B specifies audible, visual, or audiovisual intervals. Using 10 breaths per minute as an example, the interval for 10 breaths per minute is equal to “3”. Consequently, every 3 seconds, an audible, visual, or audiovisual indication is provided to the care recipient. This signal indicates when to inhale or when to exhale, inhalation being followed by exhalation, and visa versa. [0042] Returning to the discussion of FIG. 3 , breathing cycle timing generator D may also vary in functionality and complexity. In its simplest form it is an audio recording of varying interval played on a compact disc (CD) or MP3 player, in its visual form, a video tape or digital video disc (DVD) played on a VHS or a DVD player, and in it's most complex form a software program that is digitally generating the respective intervals on a personal computer (PC), laptop, palmtop, cellular telephone, or like device wherein a microprocessor exists to digitally synthesize audio signals containing the target intervals. In the form of a CD or DVD, multiple tracks are provided, one track supporting each breathing frequency of interest. These tracks may be repeated or played sequentially depending on the length of the track and the length of practice required. Display B and breathing cycle timing generator D may be discrete or integrated into a single element, an example of which is a personal computer. Of course the potential exists to create a purpose built microprocessor or integrated circuit based device for programmatically generating the required audible, visual, or audiovisual outputs. [0043] Referring now to FIG. 5 , a second preferred embodiment of the present invention is the “integrated training and monitoring system” that can be carried and applied in normal walks of life. This embodiment allows a person to both practice their breathing skill as well as monitor themselves for the purpose of identifying those times when their breathing rate increases above the desired range such that corrective action may be taken in the moment. This is useful to those that desire to reinforce a new breathing behavior as well as for those whose present health status requires that they take immediate action to maintain a relatively low breathing rate, for example a person recovering from a stroke. A complete discussion of the operation of this embodiment follows. [0044] Care recipient A, is fitted with the integrated training and monitoring system of FIG. 5 . This system may take numerous forms depending on packaging format and extent of integration. This may take the form of an instrument placed in the pocket, hung on the belt, worn on the wrist, or other. The recipient is fitted with a monitoring apparatus of either a pulse G, or mechanical motion H type. The mechanical motion monitor may fitted around torso with at belt assembly such that it detects the expansion and contraction of the torso with breathing. The pulse monitor may be attached to the earlobe, a finger, the wrist, etc. The unit is turned on. When so enabled, breathing sensor D begins monitoring the breathing frequency and depth on a continuous basis, frequency being a function of period and depth being a function of amplitude. If at any time, the breathing frequency or depth exceeds limits, an alert is provided. Depending on the options selected, as detailed in FIG. 6 , upon the alert, the training function of the unit principally consisting of breathing cycle timing generator E and audible, visual, or audiovisual display F, is initiated resulting in the presentation of an audible, visual, or audiovisual signal to which the care recipient is to synchronize their breathing. This signal is of a lower frequency that the present rate of breathing and intended to guide the recipient back to a viable breathing frequency and lower state of sympathetic activity. This signal continues until the breathing frequency falls below the specified threshold. This has the effect of modifying the tendency toward sympathetic predominance in the moment, the result being the maintenance of a relatively lower heartbeat rate and resultant blood pressure. [0045] Throughout the day, in the absence of an alert, the care recipient may turn on the training function of the device, principally involving breathing cycle timing generator H and audio, visual, or audiovisual display F, and practice breathing at the target rate, this having been preestablished per the instructive method detailed later. [0046] The integrated training and monitoring system B, consists principally of programmability interface C, breathing sensor D, breathing cycle timing generator E, and display F. Breathing sensor D, supports two sensing options, pulse monitor G, via which the heart rate variability signal can be derived for purposes of determining breathing rate and depth, and mechanical sensor H, which senses the contraction and expansion of the torso commensurate with frequency and depth of breathing. Programmability aspects of programmability interface C are detailed in FIG. 6 . [0047] FIG. 7 provides a logical description of the basic control systems of preferred embodiments as described in FIGS. 3 and 5 . Control subsystem C may be implemented in hardware, software, or hardware and software and may employ a microprocessor, microcontroller, digital signal processor, application specific integrated circuit, discrete logic, or any combination thereof. Analog or digital information representing audio, visual, or audiovisual breathing intervals may be stored in digital or analog form by storage media subsystem G and retrieved for purposes of generating audible, visual, or audiovisual signals for presentation to the user. Breathing signal information may also stored in memory as data and instruction sequences for purposes of synthesizing breathing signal by control subsystem C for purposes of presentation to the user. [0048] An instructive method is also specified for use by respiratory care practitioners and care recipients. [0000] Instructive Method for Reducing Sympathetic Predominance, and Consequent Positive Modifications to its Attendant Symptomology Hypertension: [0000] 1. A careful overview of care recipients health status and background are conducted. 2. A breath therapy strategy is developed and discussed between care recipient and practitioner. 3. The care recipient is instructed to assume a comfortable posture. 4. The care practitioner or care recipient attaches breathing cycle monitoring apparatus. This may be a discrete monitoring apparatus per the embodiment of FIG. 3 or an integrated apparatus per the embodiment of FIG. 6 . 5. The care practitioner or care recipient assesses and records the present breathing cycle. 6. If appropriate, care practitioner or care recipient attaches blood pressure measurement apparatus and records present blood pressure readings. 7. Per terms of the breathing therapy developed in step 2, a training strategy is selected involving the selection of one or more breathing frequencies in descending order, for example, 18 breathing cycles per minute followed by 15 breathing cycles per minute. A decision is also made as to how long to train each breathing cycle. 8. The care practitioner or recipient turns on the breathing cycle timing generator and the recipient begins practice. 9. The care practitioner instructs the recipient to inhale on the first cue and exhale on the successive cue, inhaling and then exhaling on cue for the duration of the practice. 10. The care practitioner instructs the recipient to align the end of their exhalation and the beginning of their inhalation with the first signal and the end of their inhalation and the beginning of their exhalation with the second signal as closely as is comfortably possible. 11. The care recipient practices in this manner for the duration of the training period. 12. The care practitioner monitors the correctness and comfort of the recipient during the process. 13. At the end of the training session, the care practitioner instructs the recipient that they are to attempt to maintain this relatively slower rate of breathing throughout their daily activities. 14. As is appropriate, the care practitioner or care recipient once again assesses the blood pressure and records the results. 15. Over the course of time, with adequate adoption of the new breathing behavior, i.e. practice and incorporation in to daily life, the frequency of the breathing cycle is lowered with a corresponding decrease in blood pressure. 16. The objective is for the care recipient to reach the final objective of 1 breath in 11.76 seconds or 5 breaths in approximately 1 minute. This requires the recipient to inhale and exhale every 5.88 seconds. This also requires a certain “depth” in inhalation and exhalation. 17. Once the recipient is fully capable and comfortable with breathing at the target rate and depth, the formal modification phase is at an end and the maintenance phase begins. 18. The care practitioner instructs the care recipient that in order to maintain this breathing frequency continuous practice is required. This is necessary so that awareness of the breathing cycle remains and to prevent a gradual return to a higher breathing cycle frequency. 19. As is appropriate, the care practitioner instructs the care recipient to monitor and record their blood pressure on a regular basis. 20. In the acute case, where high blood pressure is of severe concern, the care practitioner fits the care recipient with the integrated training and monitoring apparatus of FIG. 5 and instructs the care recipient in the use thereof. This course of action may take place as early as step 3 if deemed appropriate. 21. In this case, breathing frequency is monitored on an ongoing basis during waking hours. If at any time the breathing frequency increases above a certain threshold or breathing depth decreases below a certain threshold, an alert is sounded. Depending on options selected, upon the alert an audible, visual, or audiovisual signal may begin automatically to which the care recipient is to synchronize their breathing. This signal continues until the breathing frequency and depth falls below specified thresholds. This has the effect of modifying the tendency toward sympathetic predominance in the moment. Relative to hypertension, the result being the maintenance of a relatively lower heartbeat rate and resultant blood pressure. [0070] Those skilled in the art will recognize improvements and modifications to the preferred embodiments of the present invention. All such improvements and modifications are considered within the scope of the concepts disclosed herein and the claims that follow.

The invention specifies a method and system for leading a person suffering from “sympathetic predominance”, a specific symptom of which is “hypertension”, to breathe according to a certain pattern for the express purpose of positively altering the condition of sympathetic predominance (over activation), having the effect of bringing the autonomic nervous system into the state of balance, with consequent reductions in “tenseness”, blood pressure, muscular tightness, and emotional strain, as well as the alleviation of the myriad of subtle neuro-physiological consequences resulting from sympathetic predominance potentially including headaches, anxiety, sleep disorders, allergies, and other maladies that have yet to be attributed to this condition, thus leading to a general improvement in health, well being, and homeostasis. It accomplishes this by systematically reducing the breathing frequency with consequent increases in breathing depth, the ultimate goal being the realization and ongoing maintenance of 1 complete breathing cycle in 11.76 seconds or 5 complete breathing cycles in 58.8 seconds, the result being improved health, well being, and homeostasis.

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to a device for measuring a gas flow, of the type having a measurement chamber and an ultrasonic transceiver unit which can be attached to the measurement chamber over the openings thereof and which is provided with transmit and receive heads which are oriented against the openings of the measurement chamber, with membranes being arranged between the measurement chamber and the transmit and receive heads which are permeable to ultrasound waves, but largely impermeable to moisture and bacteria. 2. Description of the Prior Art German PS4 222 286 describes an ultrasonic flow meter of the above type in which the transmitter and the receiver are arranged at a distance from each other along a measuring tube. The measuring length extends obliquely to the axis of a tubular measurement chamber through which the medium flows whose flow rate is to be determined. This flow meter is known as a spirometer for determining the lung capacity of the patient. In order to maintain hygiene, a sterile insertion tube is inserted into the measurement chamber with each new patient. The sterile tube is provided with measurement windows which are fitted so that they are situated over the openings. Membranes which are permeable to ultrasound signals but impermeable to moisture and bacteria are arranged in the measurement windows, so that the ultrasound signals along the measuring tube can pass through the sterile insertion tube. It is therefore unnecessary for the hospital personnel to autoclave the flow meter after every use, which is advantageous since the ultrasonic transceiver unit, in particular, are sensitive parts in the flow meter. In connection with the known ultrasonic flow meer, the membranes, which are arranged at a distance from the ultrasonic transmit and receive heads, can be foam rubber, in one example, and a Mylar® film, in another. In connection with the first example, in order to be able to reach the transmit or receive unit, the ultrasound signals must first pass through the relatively thick foam rubber membrane, and then a relatively large air gap. This transition from a relatively thick membrane to a relatively large air gap can lead to a high acoustical impedance, i.e. to a high sound wave reflection. This can lead to relatively large acoustical losses, so that an unacceptably low sound signal reaches the transmit or receive heads. A relatively low acoustical impedance is associated with the use of a Mylar® film, due to its extreme thinness, so that a receivable sound signal can reach the aforementioned heads. The disadvantage of Mylar® films which are attached as described is that they are so thin and sensitive that they cannot always withstand the mechanical stress they are exposed to when a pressure excess arises in the measurement chamber, which can cause the films to easily rip. SUMMARY OF THE INVENTION It is an object of the present invention to provide a device of the type initially described wherein maximum acoustical energy is fed to the ultrasonic transceiver unit, while moisture and germs are kept away from the unit. This object is inventively achieved in a device for measuring a gas flow the membranes are removably arranged close to the transmit and receive heads. Since the membranes are removable, they can be removed after an examination and replaced by new membranes in connection with a new patient. As an alternative, the membranes can potentially be cleaned and reused. Since the membranes are arranged close to the transmit and receive heads, the acoustical impedance is effectively lowered, and more acoustical energy is fed to these heads. Due to the placement of the membranes, very thin metal or polymer membranes can be used, for example, since they are no longer exposed to a mechanical stress in this position. A thicker membrane, made of foam rubber, for example, can now be used with nearly an equally good acoustical energy feed to the transmit and receive heads. The advantage of a thick membrane is its good durability. The article "Impedance-Matched Metallurgically Sealed Transducers" (IEEE Transactions on Sonics and Ultrasonics, Vol. SU-31, No. 2, March 1984:101-104) teaches a robust ultrasonic sensor whose head is provided with a relatively thick membrane, which is connected to the sensor and which is permeable to ultrasound waves, but not to moisture and bacteria. In front of the membrane, a thin plastic film is attached which is provided exclusively to reduce the acoustical impedance, which is otherwise relatively high if a metal membrane as described is used. It is not stated in the article that the thin plastic film eliminates the possibility of moisture and bacteria reaching the metal membrane. Thus, despite the metal membrane and the plastic film, it is necessary when using this sensor in connection with an ultrasonic flow meter to autoclave this sensor prior to each new patient, since moisture and bacteria may be present on the metal membrane. Regular auto claving of the sensor results in a shortened lifetime. In an embodiment of the inventive device, each transmit and receive head presses against the respective membrane. In such an embodiment, the membranes are fastened in the measurement chamber removably, for example. If the heads are pressed against the respective membranes, nearly all the air between the membrane and the head is pressed to the side, so that the heads become situated close to the respective membrane, thereby enabling a further reduction of the acoustical impedance. In another embodiment of the inventive device, it is proposed that the membrane is attached to the transmit and receive head. The heads of the transmitter and of the receiver can thus be provided with membranes before being attached to the measurement chamber. Subsequent to the examination, the transmitter and receiver are detached from the measurement chamber, the membranes are replaced and the transmitter and receiver are used in connection with a new patient. In another embodiment of the inventive device, each transmit and receive head is connected to the membrane by means of an adhesive, at least over a part of the head surface. The membrane is appropriately provided with an adhesive layer. The adhesive layer is removed from the head in the replacement of the membrane. Because the membrane has a mechanical connection to the head in this type of embodiment, the acoustical impedance is again lowered. There is mechanical stability of the membrane here as well. DESCRIPTION OF THE DRAWINGS FIG. 1 shows the basic components of a first embodiment of an inventive measuring device, in a longitudinal section. FIG. 2 shows the basic components of a second embodiment of inventive measuring device, in a longitudinal section. FIG. 3 shows the basic components of a third embodiment of an inventive measuring device, in a longitudinal section. FIG. 4 shows the structure of a part of a measuring device according to FIG. 3. FIG. 5 shows the construction of the same part of the measuring device as in FIG. 4, but in another embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 schematically depicts an ultrasonic flow meter 1 wherein an ultrasonic transmitter 2 and an ultrasonic receiver 3 is and arranged along a channel 4, which serves as a measuring length, at a distance from one another. The channel 4 extends obliquely to the axis 5 of a tubular measurement chamber 6 through which the medium flows whose flow rate is to be determined. The flow meter is what is known as a spirometer for determining the lung capacity of the patient. The ultrasonic transmitter 2 and the receiver 3 are respectively provided with transmit and receive heads 7,8, which are directed toward respective openings 9, 10 in the measurement chamber 6 through which the measuring length extends. This general type of ultrasonic flow meter 1 is demonstrated and described in PCT Application WO 94/28790. Membranes 11, 12 are provided in the inventive ultrasonic flow meter 1 which are permeable to ultrasound waves but largely impermeable to moisture and bacteria and which are arranged close to the transmit and receive heads 7, 8. In this exemplary embodiment, the inner diameter of the channel 4 is approximately as large as the outer diameter of the transmit and receive heads 7,8. In this type of embodiment it is advantageous to attach the membranes 11, 12 directly to the transmit and receive heads 7, 8, respectively, with an adhesive, for example. The application of the metal or polymer membranes 11, 12 close to the respective transmit and receive head 7,8 results in a relatively low acoustical impedance, enabling a relatively large amount of acoustical energy to be supplied. Given this type of application, relatively thick membranes can be attached without a notable reduction of the acoustical energy reaching the respective heads 7, 8. A very small acoustical impedance is obtained if a thin membrane is used. Since the membranes 11, 12 are connected to the respective heads 7,8 via an adhesive in the exemplary embodiment, the membranes 11, 12 are brought into mechanical contact with the heads 7, 8, achieving a further reduction of the acoustical impedance. Since the membranes 11, 12 are replaceable, they are removed after an examination, and new membranes 11, 12 are applied prior to each new patient. As an alternative, the membranes 11, 12 can be autoclaved and reused. FIG. 2 shows an ultrasonic flow meter 1, which differs from the ultrasonic flow meter 1 described in connection with FIG. 1 in that the inner diameter of the channel 4 is greater than the outer diameter of the respective transmit and receive heads 7, 8. Another difference is that the membranes 11, 12 are removably attached to the respective open ends 13, 14 of the channel 4. By pressing the respective heads 7, 8 of the transmitter 2 and the receiver 3 against the respective membranes 11, 12, almost all the air between the membranes 11, 12 and the heads 7, 8 is expelled, allowing the heads 7, 8 to be situated close against the membranes 11,12. In this exemplary embodiment, the membranes 11,12 need not be provided with an adhesive. In connection with the embodiment described in FIG. 2, the ultrasonic transmitter 2, the ultrasonic receiver 3 and the membranes 11, 12 can be removed after each examination, and new membranes can be applied to the respective heads 7, 8 prior to each patient. The transmitter and receiver are subsequently pressed against the respective membranes 11, 12 again, as described, and are locked in this position. FIG. 3 depicts another schematically illustrated ultrasonic flow meter 15. In connection with this flow meter, the transmitter 17 and the receiver 18 are arranged on the same side of the elongated measurement chamber 18. The transmitter 16 can emit an acoustical signal, referenced 19, which is transmitted, via a number of reflections at the walls of the measurement chamber 18, through a gas mixture that flows through the measurement chamber 18, in order to subsequently strike the receiver, which accepts the transmitted acoustical signal. This general type of ultrasonic flow meter 15 is detailed in European Application 0 874 238. The diameter of those openings 20, 21 which are arranged at the measurement chamber and which are provided for the transmitter 16 and the receiver 17 is inventively approximately equally as large as the outer diameter of the respective heads 22, 23 of the transmitter 16 and the receiver 17. In this exemplary embodiment, a retainer 24 is arranged at the measurement chamber 18, containing a rolled stock of ribbon-shaped membrane 25. Prior to an examination, the ribbon-shaped membrane 25 is rolled far enough out of the retainer so that it covers the two openings 20, 21 of the measurement chamber 18. The membrane 25 can be provided with an adhesive at least on the side which comes to rest against the outer wall of the measurement chamber 26, in order to be able to apply the membrane rapidly and easily. The transmitter 16 and the receiver 17 are subsequently attached against the membrane 25 at the respective openings 21, 22. The membrane 25 can also be provided with an adhesive on the side directed opposite the measurement chamber 18. This is preferred and results in a very good contact between the heads 22, 23 and the membrane 25. The outer wall of the measurement chamber 18 is provided with a tear part 26 for the membrane 22. Subsequent to an examination, the transmitter 16 and the receiver are removed. The membrane 25 is detached from the outer wall of the measurement chamber 18. Subsequently, another length of membrane 25 is pulled out of the retainer 25 prior to the next examination, until the membrane 2 covers the openings 21, 22, the membrane 25 which was used in the preceding measurement being torn off with the aid of the tear part 26. The transmitter 16 and the receiver 17 are subsequently applied against the membrane 25 again. FIG. 4 illustrates that the openings 20, 21 can be larger than the outer diameter of the respective head 22,23 of the transmitter 16 and of the receiver 17. In this exemplary embodiment, the transmitter 16 or the receiver 17 can be pressed against the membrane in order to reduce an air gap between said parts to a minimum, as described in connection with FIG. 2. In connection with this example, the part of the membrane 25 which faces the transmitter 26 or the receiver 17 need not necessarily be provided with an adhesive. The FIG. 4 depicts the opening 21 with the transmitter 16 only. FIG. 5 illustrates that a sealing ring can be attached between the outer wall of the measurement chamber 18 and the membrane 28. In this type exemplary embodiment, it is advantageous for each opening 20, 21 of the measurement chamber 18 to be respectively provided with a membrane 28. The sealing ring 27 produces a good seal between the interior of the measurement chamber 18 3nd the atmosphere. FIG. 5 depicts the opening 21 with the transmitter 16 only. The opening 20 and the receiver 17 preferably have the same shape. Although the present invention has been described with reference to a specific embodiment, those of skill in the art will recognize that changes may be made thereto without departing from the scope and spirit of the invention as set forth in the appended claims.

A device for measuring a gas flow, has a measurement chamber and an ultrasonic transceiver unit which can be attached to the measurement (chamber over openings of the measurement chamber and which is provided with transmit and receive heads. The heads are directed against the openings of the measurement chamber, membranes being arranged between the measurement chamber and the transmit and receive heads which are permeable to ultrasound waves but largely impermeable to moisture and bacteria. In order to feed maximum acoustical energy to the ultrasonic transceiver unit while keeping moisture and bacteria away from the unit, the membranes are replaceably arranged close to the transmit and receive heads.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application is a divisional of U.S. application Ser. No. 10/906,386, filed Feb. 17, 2005, which claims the benefit of U.S. Provisional Application Ser. No. 60/521,073, filed Feb. 17, 2004, each of which is incorporated herein by reference. GOVERNMENT SUPPORT [0002] This invention was developed under support from the National Science Foundation under grants OPP-9901076 and OPP-0125152; accordingly the U.S. government has certain rights in the invention. BACKGROUND OF THE INVENTION [0003] One of the greatest efforts of modern medicine is the control and abatement of cellular proliferative disorders, such as cancers. Considerable research has been conducted searching for new biologically active compounds having useful activity for specific cancers and the organisms which produce these compounds. For example, certain marine soft corals have shown to be a source of biologically active cytotoxins. Also, compounds from sponges have proven effective against lipoxygenase-mediated conditions in humans (See U.S. Pat. No. 6,750,247 to Crews et al.) [0004] Tunicates have proven to be an important source of bioactive natural products. Among marine natural products that have advanced as cancer treatments the ecteinascidins and didemnins are derived from tunicates, and the eudistomins have potent antiviral activity. As part of an ongoing study of bioactivity among Antarctic marine invertebrates, the inventors had the occasion to study the tunicate Synoicum adareanum. [0005] S. adareanum is a circumpolar tunicate common in the shallow waters around Anvers island (64° 46′S, 64° 03′W) on the Antarctic Peninsula from 15 to 796 meters depth. S. adareanum colonies consist of large rounded or club-shaped heads with the bottom stalk being wrinkled and leathery and only slightly narrower than the head. S. adareanum colonies can be up to eighteen centimeters high with a diameter of twelve centimeters. S. adareanum colonies may comprise a single head or, up to six heads can arise from a single stalk. SUMMARY OF INVENTION [0006] Extracts from S. adareanum , Palmerolide A (1), Palmerolide C, Palmerolide D, and Palmerolide E displayed bioactivity in field-based feeding-deterrent assays, leading the inventors to investigate the chemical nature of the activity. Presented are novel, isolated polyketides, Palmerolide A (1), Palmerolide C, Palmerolide D, and Palmerolide E as the major natural product from extracts of S. adareanum . These polyketides display selective cytotoxicity in the National Cancer Institute (NCI) 60 cell line panel inhibiting, inter alia, melanoma (UACC-64, LC 50 0.018 μM) with three orders of magnitude greater sensitivity relative to other cell lines tested. [0007] In a general embodiment, the present invention provides a method of treating a subject with cancer, comprising administering to the subject a therapeutically effective amount of at least one isolated compound obtained from extracts of a Synoicum species. In this embodiment, the Synoicum species is S. adareanum and the isolated compound obtained from the Synoicum species is a Palmerolide. The Palmerolide is chosen from the group consisting of Palmerolide A(1), Palmerolide C, Palmerolide D, and Palmerolide E. [0008] In an alternate embodiment, a composition (or an isomer, racemate or racemic mixture thereof, or a pharmaceutically acceptable salt thereof) is provided comprising an isolated compound of the formula: [0000] [0009] In yet another embodiment the present invention provides for a composition (or an isomer, racemate or racemic mixture thereof, or a pharmaceutically acceptable salt thereof) comprising an isolated compound of the formula: [0000] [0010] An additional embodiment the present invention provides for a composition (or an isomer, racemate or racemic mixture thereof, or a pharmaceutically acceptable salt thereof) comprising an isolated compound of the formula: [0000] [0011] The present invention also provides for a composition (or an isomer, racemate or racemic mixture thereof, or a pharmaceutically acceptable salt thereof) comprising an isolated compound of the formula: [0000] BRIEF DESCRIPTION OF THE DRAWINGS [0012] FIG. 1 is a perspective view of the chemical formula for Palmerolide A. [0013] FIG. 2 is a chart showing the NMR Data for Palmerolide A. [0014] FIG. 3 depicts selected ROE correlations relating the relative stereochemistry between C-11 and C-19. [0015] FIG. 4 is a chart showing the National Cancer Institute (NCI) Developmental Therapeutics Program In-Vitro Testing Results for Palmerolide A. [0016] FIG. 5 is a continued chart, showing the National Cancer Institute (NCI) Developmental Therapeutics Program In-Vitro Testing Results for Palmerolide A. [0017] FIG. 6 is a graph showing National Cancer Institute (NCI) Developmental Therapeutics Program Dose Response Curves for all cell lines tested for Palmerolide A. [0018] FIG. 7 is a graph showing National Cancer Institute (NCI) Developmental Therapeutics Program Dose Response Curves for Melanoma cell lines tested for Palmerolide A. [0019] FIG. 8 is a graph showing National Cancer Institute (NCI) Developmental Therapeutics Program Dose Response Curves for Colon Cancer cell lines tested for Palmerolide A. [0020] FIG. 9 is a graph showing National Cancer Institute (NCI) Developmental Therapeutics Program Dose Response Curves for Renal Cancer cell lines tested for Palmerolide A. [0021] FIG. 10 is perspective view of the chemical formula for Palmerolide C. [0022] FIG. 11 is a chart showing the NMR Data for Palmerolide C. [0023] FIG. 12 is a chart showing the National Cancer Institute (NCI) Developmental Therapeutics Program In-Vitro Testing Results for Palmerolide C. [0024] FIG. 13 is a continued chart, showing the National Cancer Institute (NCI) Developmental Therapeutics Program In-Vitro Testing Results for Palmerolide C. [0025] FIG. 14 is a graph showing National Cancer Institute (NCI) Developmental Therapeutics Program Dose Response Curves for all cell lines tested for Palmerolide C. [0026] FIG. 15 is a perspective view of the chemical formula for Palmerolide D. [0027] FIG. 16 is a chart showing the NMR Data for Palmerolide D. [0028] FIG. 17 is a perspective view of the chemical formula for Palmerolide E. [0029] FIG. 18 is a chart showing the NMR Data for Palmerolide E. [0030] FIG. 19 is a chart showing the National Cancer Institute (NCI) Developmental Therapeutics Program In-Vitro Testing Results for Palmerolide E. [0031] FIG. 20 is a continued chart, showing the National Cancer Institute (NCI) Developmental Therapeutics Program In-Vitro Testing Results for Palmerolide E. [0032] FIG. 21 is a graph showing National Cancer Institute (NCI) Developmental Therapeutics Program Dose Response Curves for all cell lines tested for Palmerolide E. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0033] In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part hereof, and within which are shown by way of illustration specific embodiments by which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the invention. Terms [0034] Those skilled in the art will recognize that the Palmerolide compounds disclosed herein can exist in several tautomeric forms. All such tautomeric forms are considered as part of this invention. [0035] “Pharmaceutically acceptable carrier” refers to any carrier, diluent, excipient, wetting agent, buffering agent, suspending agent, lubricating agent, adjuvant, vehicle, delivery system, emulsifier, disintegrant, absorbent, preservative, surfactant, colorant, flavorant, or sweetener, preferably non-toxic, that would be suitable for use in a pharmaceutical composition. [0036] “Pharmaceutically acceptable equivalent” includes, without limitation, pharmaceutically acceptable salts, hydrates, metabolites, prodrugs and isosteres. Many pharmaceutically acceptable equivalents are expected to have the same or similar in vitro or in vivo activity as the compounds of the invention. [0037] “Pharmaceutically acceptable salt” refers to a salt of the inventive compounds which possesses the desired pharmacological activity and which is neither biologically nor otherwise undesirable. The salt can be formed with acids that include, without limitation, acetate, adipate, alginate, aspartate, benzoate, benzenesulfonate, bisulfate butyrate, citrate, camphorate, camphorsulfonate, cyclopentanepropionate, digluconate, dodecylsulfate, ethanesulfonate, fumarate, glucoheptanoate, glycerophosphate, hemisulfate, heptanoate, hexanoate, hydrochloride hydrobromide, hydroiodide, 2-hydroxyethane-sulfonate, lactate, maleate, methanesulfonate, 2-naphthalenesulfonate, nicotinate, oxalate, thiocyanate, tosylate and undecanoate. Examples of a base salt include ammonium salts, alkali metal salts such as sodium and potassium salts, alkaline earth metal salts such as calcium and magnesium salts, salts with organic bases such as dicyclohexylamine salts, N-methyl-D-glucamine, and salts with amino acids such as arginine and lysine. The basic nitrogen-containing groups can be quarternized with agents including lower alkyl halides such as methyl, ethyl, propyl and butyl chlorides, bromides and iodides; dialkyl sulfates such as dimethyl, diethyl, dibutyl and diamyl sulfates; long chain halides such as decyl, lauryl, myristyl and stearyl chlorides, bromides and iodides; and aralkyl halides such as benzyl and phenethyl bromides. [0038] “Prodrug” refers to a derivative of the inventive compounds that undergoes biotransformation, such as by metabolism, before exhibiting a pharmacological effect. [0039] The prodrug is formulated with the objective of improved chemical stability, improved patient acceptance and compliance, improved bioavailability, prolonged duration of action, improved organ selectivity, improved formulation (e.g., increased hydrosolubility), and/or decreased side effects (e.g., toxicity). The prodrug can be readily prepared from the inventive compounds using methods known in the art, such as those described by Burger's Medicinal Chemistry and Drug Chemistry, Fifth Ed., Vol. 1, pp. 172-178, 949-982 (1995). [0040] “Palmerolide,” as used herein, refers to a multi-membered macrocyclic polyketide bearing carbonate and amide functionality. In one embodiment, the Palmerolide is isolated from the tunicate Synoicum adareanum ; collected from the vicinity of Palmer Station on the Antarctic Peninsula. [0041] “Polyketides,” as used herein, refers to any natural compound containing alternating carbonyl and methylene groups β-polyketones), derived from repeated condensation of acetyl coenzyme A. [0042] “Macrocycle,” as used herein, refers to a large molecule arranged in a circle with various semi-compounds attached at various points. The point of attachment and the nature of the sub-molecule determines the nature and physiological effect of the compound which contains it. [0043] “Macrolide,” as used herein, refers to a class of antibiotics characterized by molecules made up of large-ring lactones. [0044] “Olefin,” as used herein, is synonymous with “alkene” and refers to an acyclic hydrocarbon containing one or more double bonds. [0045] As used herein, “a clinical response” is the response of a cell proliferative disorder, such as melanoma, colon and renal cancer, to treatment with novel compounds disclosed herein. Criteria for determining a response to therapy are widely accepted and enable comparisons of the efficacy alternative treatments (see Slapak and Kufe, Principles of Cancer Therapy, in Harrisons's Principles of Internal Medicine, 13 th edition, eds. Isselbacher et al., McGraw-Hill, Inc. 1994). A complete response (or complete remission) is the disappearance of all detectable malignant disease. A partial response is an approximately 50 percent decrease in the product of the greatest perpendicular diameters of one or more lesions. There can be no increase in size of any lesion or the appearance of new lesions. Progressive disease means at least an approximately 25 percent increase in the product of the greatest perpendicular diameter of one lesion or tumor or the appearance of new lesions or tumors. The response to treatment is evaluated after the subjects had completed therapy. Pharmaceutical Compositions [0046] A “pharmaceutical composition” of the invention is formulated to be compatible with its intended route of administration. Examples of routes of administration include parenteral, intravenous, intradermal, subcutaneous, oral inhalation, transdermal (topical), transmucosal, and rectal administration. Solutions or suspensions used for parenteral, intradermal, or subcutaneous application can include the following components: a sterile diluent such as water for injection, saline solution, fixed oils, polyethylene glycols, glycerine, propylene glycol or other synthetic solvents; antibacterial agents such as benzyl alcohol or methyl parabens; antioxidants such as ascorbic acid or sodium bisulfite; chelating agents such as ethylenediaminetetraacetic acid; buffers such as acetates, citrates or phosphates and agents for the adjustment of tonicity such as sodium chloride or dextrose. pH can be adjusted with acids or bases, such as hydrochloric acid or sodium hydroxide. The parenteral preparation can be enclosed in ampoules, disposable syringes or multiple dose vials made of glass or plastic. [0047] Pharmaceutical compositions suitable for injectable use include sterile aqueous solutions (where water soluble) or dispersions and sterile powders for the extemporaneous preparation of sterile injectable solutions or dispersion. For intravenous administration, suitable carriers include physiological saline, bacteriostatic water, or phosphate buffered saline (PBS). In all cases, the composition must be sterile and should be fluid to the extent that easy syringability exists. It must be stable under the conditions of manufacture and storage and must be preserved against the contaminating action of microorganisms such as bacteria and fungi. The carrier can be a solvent or dispersion medium containing, for example, water, ethanol, polyol (for example, glycerol, propylene glycol, and liquid polyetheylene glycol, and the like), and suitable mixtures thereof. The proper fluidity can be maintained, for example, by the use of a coating such as lecithin, by the maintenance of the required particle size in the case of dispersion and by the use of surfactants. Prevention of the action of microorganisms can be achieved by various antibacterial and antifungal agents, for example, parabens, chlorobutanol, phenol, ascorbic acid, thimerosal, and the like. In many cases, it will be preferable to include isotonic agents, for example, sugars, polyalcohols such as mannitol, sorbitol, sodium chloride in the composition. Prolonged absorption of the injectable compositions can be brought about by including in the composition an agent which delays absorption, for example, aluminum monostearate and gelatin. [0048] Sterile injectable solutions can be prepared by incorporating the active compound in the required amount in an appropriate solvent with one or a combination of ingredients enumerated above, as required, followed by filtered sterilization. Generally, dispersions are prepared by incorporating the active compound into a sterile vehicle which contains a basic dispersion medium and the required other ingredients from those enumerated above. In the case of sterile powders for the preparation of sterile injectable solutions, the preferred methods of preparation are vacuum drying and freeze-drying which yields a powder of the active ingredient plus any additional desired ingredient from a previously sterile-filtered solution thereof. [0049] Oral compositions generally include an inert diluent or an edible carrier. They can be enclosed in gelatin capsules or compressed into tablets. For the purpose of oral therapeutic administration, the active compound can be incorporated with excipients and used in the form of tablets, troches, or capsules. Oral compositions can also be prepared using a fluid carrier for use as a mouthwash, wherein the compound in the fluid carrier is applied orally and swished and expectorated or swallowed. Pharmaceutically compatible binding agents, and/or adjuvant materials can be included as part of the composition. The tablets, pills, capsules, troches and the like can contain any of the following ingredients, or compounds of a similar nature: a binder such as microcrystalline cellulose, gum tragacanth or gelatin; an excipient such as starch or lactose, a disintegrating agent such as alginic acid, Primogel, or corn starch; a lubricant such as magnesium stearate or Sterotes; a glidant such as colloidal silicon dioxide; a sweetening agent such as sucrose or saccharin; or a flavoring agent such as peppermint, methyl salicylate, or orange flavoring. For administration by inhalation, the compounds are delivered in the form of an aerosol spray from pressured container or dispenser which contains a suitable propellant, a gas such as carbon dioxide, or a nebulizer. [0050] Systemic administration can also be by transmucosal or transdermal means. For transmucosal or transdermal administration, penetrants appropriate to the barrier to be permeated are used in the formulation. Such penetrants are generally known in the art, and include, for example, for transmucosal administration, detergents, bile salts, and fusidic acid derivatives. Transmucosal administration can be accomplished through the use of nasal sprays or suppositories. For transdermal administration, the active compounds are formulated into ointments, salves, gels, or creams as generally known in the art. The compounds can also be prepared in the form of suppositories (for example, with conventional suppository bases such as cocoa butter and other glycerides) or retention enemas for rectal delivery. [0051] In one embodiment, the active compounds are prepared with carriers that will protect the compound against rapid elimination from the body, such as a controlled release formulation, including implants and microencapsulated delivery systems. Biodegradable, biocompatible polymers can be used, such as ethylene vinyl acetate, polyanhydrides, polyglycolic acid, collagen, polyorthoesters, and polylactic acid. Methods for preparation of such formulations will be apparent to those skilled in the art. The materials can also be obtained commercially from Alza Corporation and Nova Pharmaceuticals, Inc. Liposomal suspensions (including liposomes targeted to infected cells with monoclonal antibodies to viral antigens) can also be used as pharmaceutically acceptable carriers. These can be prepared according to methods known to those skilled in the art. [0052] A “therapeutically effective amount” is the amount of Palmerolide A, C, D, or E, or any combination thereof necessary to provide a therapeutically effective amount of the corresponding compound in vivo. The amount of the compound must be effective to achieve a response, such as, but not limited to total prevention of (protection against) and to improved survival rate or more rapid recovery, or improvement or elimination of symptoms associated with a cellular proliferative disease or other indicators as are selected as appropriate measures by those skilled in the art. In accordance with the present invention, a suitable single dose size is a dose that is capable of preventing or alleviating (reducing or eliminating) a symptom in a patient when administered one or more times over a suitable time period. One of skill in the art can readily determine appropriate single dose sizes for systemic administration based on the size of a mammal and the route of administration. Example I Hollow Fiber Assay for Preliminary In Vivo Testing [0053] The Biological Testing Branch of the Developmental Therapeutics Program has adopted a preliminary in vivo screening tool for assessing the potential anticancer activity of compounds identified by the large scale in vitro cell screen. This hollow fiber based assay has been in use since June, 1995. [0054] Each compound is tested against a standard panel of 12 human tumor cell lines including NCI-H23, NCI-H522, MDA-MB-231, MDA-MB-435, SW-620 COLO 205, LOX IMVI, UACC-62, OVCAR-3, OVCAR 5, U251 and SF-295. The cell lines are cultivated in RPMI-1640 containing 10% FBS and 2 mM glutamine. On the day preceding hollow fiber preparation the cells are given a supplementation of fresh medium to maintain log phase growth. For fiber preparation the cells are harvested by standard trypsinization technique and resuspended at the desired cell density (varies by cell line between 2-10×10 6 cells/ml). The cell suspension is flushed into 1 mm I.D. polyvinylidene hollow fibers with a molecular weight exclusion of 500,000 Da. The hollow fibers are heat-sealed at 2 cm intervals and the samples generated from these seals are placed into tissue culture medium and incubated at 37° C. in 5% CO 2 for 24-48 hours prior to implantation. A total of 3 different tumor lines are prepared for each experiment so that each mouse receives 3 intraperitoneal implants (1 of each tumor line) and 3 subcutaneous implants (1 of each tumor line). On the day of implantation, samples of each tumor cell line are quantitated for viable cell mass by a stable endpoint MTT assay so that the time zero (0) cell mass is known. Thus, the cytostatic and cytocidal capacities of the test compound can be assessed. Mice are treated with experimental agents starting on day 3 or 4 following fiber implantation and continuing once daily for a total of 4 doses. Each agent is assessed by intraperitoneal injection at 2 dose levels with 3 mice/dose/experiment. Vehicle controls consist of 6 mice receiving the compound diluent only. The fibers are collected from the mice on the day following the fourth compound treatment and subjected to the stable endpoint MTT assay. The optical density of each sample is determined spectrophotometrically at 540 nm and the mean of each treatment group is calculated. The percent net cell growth in each treatment group is calculated and compared to the percent net cell growth in the vehicle treated controls. Each compound is assessed in a total of 4 experiments (3 cell lines/experiment× 4 experiments=12 cell lines). [0055] Compounds are selected for further testing (e.g. time/dose exposure studies preliminary pharmacology studies, subcutaneous xenograft efficacy studies) on the basis of several hollow fiber assay criteria. These include: (1) a reduction in net cell growth of 50% or greater in 10 of the 48 possible test combinations (12 cell lines× 2 sites× 2 compound doses); (2) a reduction in net cell growth of 50% or greater in a minimum of 4 of the 24 distant site combinations (intraperitoneal drug/subcutaneous culture); and/or (3) cell kill of 1 or more cell lines in either implant site (reduction in the viable cell mass below the level present at the start of the experiment). [0056] To simplify evaluation, a point system has been adopted which allows rapid viewing of the activity of a given compound. For this, a value of 2 is assigned for each compound dose which results in a 50% or greater reduction in viable cell mass. The intraperitoneal and subcutaneous samples are scored separately so that criteria (1) and (2) can be evaluated. Compounds with a combined IP+SC score 20 , a SC score 8 or a net cell kill of one or more cell lines can be considered for further studies. The maximum possible score for an agent is 96 (12 cell lines× 2 sites× 2 dose levels× 2 [score]). These criteria were statistically validated by comparing the activity outcomes of >80 randomly selected compounds in the hollow fiber assay and in xenograft testing. This comparison indicated that there was a very low probability of missing a xenograft active compound if the hollow fiber assay were used as the initial in viva screening tool. Because of the design of the hollow fiber assay, the results of individual cell lines are not reported since the statistical power of the assay is based on the impact of a compound against the entire panel of cells. In addition to the hollow fiber results, other factors (e.g. unique structure, mechanism of action, etc.) may result in referral of a compound for further studies without the corn pound meeting these hollow fiber assay criteria. Example II Palmerolide Isolation [0057] S. adareanum was extracted with 1:1 dichloromethane/methanol and the residue resulting from rotary evaporation was partitioned between an equal volume of water and ethyl acetate (EtOAc). Column chromatography of the EtOAc partition fraction using mixtures of hexane, ethyl acetate and methanol resulted in Fractions 4 and 5, which eluted with 2%-5% methanol/ethyl acetate (310 mg) combined. These combined fractions were further separated by gradient elution of 1-10% MeOH/CHCl 3 followed up by purification with HPLC on C-18 (40% I-120/MeCN) afforded Palmerolide A, C, D and E (see Table I below). [0000] TABLE I Example III [0058] As an illustrative example; Palmerolide A(1) was isolated as a white amorphous solid from the 1:1 methanol/ethyl acetate fraction eluting from silica gel chromatography of the crude (1:1 methanol/dichloromethane) extract. Mass spectrometric analysis provided a molecular formula of C 33 H 48 N 2 O 7 ( FIG. 1 ) (HRFABMS m/z 585.3539, Δ 0.1 mmu for [M + +1]). The C-1 to C-24 carbon backbone of Palmerolide A was unambiguously established based on 1 H- 1 H and 1 H- 13 C connectivity assignments from 2D NMR techniques as described below. [0059] The C-1 ester carbonyl of Palmerolide A (1) was found to be conjugated to the C-2/C-3 olefin based on observation of cross-correlations in the gHMBC spectrum ( FIG. 2 ) from both H-2 and H-3 to C-1. The olefinic protons were disposed trans based on the large vicinal coupling (J=152 Hz). Three methylene carbons (δ 32.6, 25.7 and 38.5) were observed by both gCOSY and gHMBC to intervene between the C-2/C-3 olefin and a hydroxymethine at δ 3.83 (H-7). A trans-distributed olefin (J=15.5 Hz) could be positioned between the aforementioned hydroxymethine and another at δ 4.15 (H-10). While H-10 showed no gHMBC correlations, H-8, H-9 and H-11 all displayed connectivity by gHMBC to C-10. H-11 could be further extended to C-12/C-13 (C-12 and C-13 are coincident in the 13 C NMR spectrum) by gHMBC and gCOSY, as well as to an ester carbonyl (OCOX) which displayed no further connectivity using these NMR techniques. In the gHMBC spectrum, H-13 coupled into the olefinic region, to C-14 and C-15. The C-14/C-15 trans-olefin (J=14.6 Hz) was shown to be conjugated to a tri-substituted olefin in positions C-16 and C-17 by gHMBC correlations of H-14, H-15, H-18 and H-19, as well as H 3 -27. The C-16/C-17 olefin must be E based on a ROESY spectrum, which demonstrated the proximity ( FIG. 3 ) of H 3 -27 to H-15. A methylene group (C-18, δ 43.9) intervenes between the C-16/C-17 olefin and an oxygen-bearing methine (C-19, δ 75.8), based on gHMBC correlations of H-16 and H 3 -27 to C-18; H-19 and H-20 similarly correlate to C-18. The 20-membered macrocycle was completed based on coupling between H-19 and the C-1 ester carbonyl in the gHMBC spectrum. [0060] Features of the macrocycle were established by further analysis of 2D NMR data. In addition to the four E olefins described above, three oxygen atoms and one methyl group were pendant on the macrocycle. Hydroxymethine protons at H-7 and H-10 were conclusively assigned based on observation of coupling of the hydroxyl protons in both the gHMBC and gCOSY spectra: in the gHMBC spectrum, the hydroxyl protons correlated to the respective x- and β-carbons, while in the gCOSY spectrum correlations were observed between the hydroxyl protons and their respective hydroxymethines. The third oxygen-bearing carbon (C-11), as described above, correlates with an ester carbonyl (OCOX) at δ 157.3. [0061] Also pendant on the macrocycle is the C-19 side chain. The H-20 multiplet, correlating to C-19 (gHMBC), was shown by gCOSY to be coupled to a methyl group (C-26, δ 0.90) and the terminus of a conjugated diene system based on H-19 and H-20 gHMBC correlations to olefinic C-21 (δ 130.5). Both the C21/C-22 and the C-23/C-24 olefins were determined to be E, based, in the former case, on a ROESY correlation between H 3 -25 and H-20, and in the latter case the basis of coupling (J=14.2 Hz). Connectivity of the C-23/C-24 olefin could be established based on gHMBC correlations of H-23 to C-21, C-22, C-24 and C-25. C-24 marked the terminus of the contiguous carbon chain and could be shown to bear an —NH group due to gHMBC correlations of an amide proton at δ 9.84 to carbons C-23, C-24 and the amide carbonyl, C-1′ (δ 163.9). [0062] The isopentenoyl substructure (C-1′ to C-5′) was unusual in displaying 4 J CH coupling in the gHMBC spectrum between the amide carbonyl (C-1′) and both vinyl methyl groups (C-4′ and C-5′). Only one vinyl methyl can be placed within the 3 J CH reach of the typical HMBC experiment optimized for 8 Hz. The 2-methyl-2-butenoyl isomer, wherein protons from one vinyl methyl reside three bonds from the carbonyl and those from the second reside four bonds distant was unlikely on chemical shift grounds, but also because the vinyl methyl groups were mutually correlated in the gHMBC spectrum, FIG. 2 . The substructure was secured as the isopentenoyl group by observation of very small coupling (J=1.0 Hz) of the vinyl proton (H-2′) to both vinyl methyl groups (C-4′ and C-5′), excluding a vicinal relationship (i.e., large J) between the vinyl proton and one vinyl methyl required by the 2-methyl-2-butenoyl isomer. [0063] The connectivity described above established the full planar structure of Palmerolide A (1) with the exception of a single open valence on the ester carbonyl attached to the macrolide at C-11. Remaining to be accounted from the molecular formula was —NH 2 . That the C-11 functional group was a carbamate is supported by the precedence of that functional group on other polyketides, most notably the anticancer agent discodermolide. [0064] The stereochemical assignment of Palmerolide A's (1) five asymmetric centers was established by the application of the modified Mosher and Murata methods. (R)- and (S)-MTPA esters's of Palmerolide A demonstrated both C-7 and C-10 to bear the R configuration. Configurational analysis of the C-10/C-11 fragment identified a gauche relationship between H-10 and H-11, based on the small 3 J H-10/H-11 observed between the vicinal protons and the large 3 J CH for both the H-10/C-12 and the H-11/C-9 relationships. Further support for the conformation was found in 2 J C-11/H-10 and 2 J C-10/H-11 , both of which were large and negative, defining the absolute stereochemistry of C-11 as R. Similarly, configurational analysis of the C-19/C-20 system suggested an anti relationship of the respective protons, based on the large 3 J H-19/H-20 , small 3 J C-21/II-19 , 3 J C-26/H-19 and 3 J C-18/H-20 , as well as the large 3 J C-19/H-20 . The relative position of C-18 in this fragment was secured by the observation of ROESY correlations between H 2 -18 and H-20 as well as H 2 -18 and H 3 -26 while no ROESY correlation was observed between H 2 -18 and H-21, requiring the relative configuration 19R*, 20S*. [0065] The four olefins in the macrocycle constrain the flexibility often found in macrolides, facilitating stereochemical analysis by NOE studies. Further analysis of the ROESY spectrum revealed the macrolide to adopt two largely planar sides of a tear-drop shaped cycle, one side consisting of C-1 through C-6, the other C-11 through C-19, with C-7 through C-10 providing a curvilinear connection. In particular, H-19, H 3 -27, H-15 and H 2 -13 (see FIG. 3 ) are sequentially correlated in the ROESY spectrum, as are H 3 -26, H 2 -18, H-16. H-14 and H-12, defining the periphery of the top and bottom face of the western hemisphere. H-11 correlates only to the top series of protons, a result consistent only with C-19 and C-11 both adopting the R configuration. The absolute stereochemistry of the C-19/C-20 fragment is therefore 19R, 20S. [0066] Tunicates are not well known as producers of type I polyketides, though the patellazoles and iejimalides are significant, bioactive, representatives. Palmerolide A (1) is unusual in bearing a small macrocycle, with 20 members, compared to 24 in the patellazoles and iejimalides, and a vinyl amide, a feature more commonly associated with cyanophyte-derived macrolides such as tolytoxin. Palmerolide A displays cytotoxicity toward several other melanoma cell lines. FIG. 2 , [M14(LC 50 0.076 μM), SK-MEL-5 (6.8 μM) and LOX IMVI (9.8 μM)] as well as the previously mentioned UACC-62. Besides melanoma, FIG. 3 , one colon cancer cell line (HCC-2998. 6.5 μM), FIG. 4 , and one renal cancer cell line (RXF 393, 6.5 μM), FIG. 5 , Palmerolide A was largely devoid of cytotoxicity (LC 50 >10 μM), representing a selectivity index among tested cell lines of 10 3 for the most sensitive cells. Significantly, Palmerolide A is COMPARE.-negative against the NCI database, suggestive of a previously un-described mechanism of action. Field and laboratory bioassay and chemical studies to address Palmerolide A's potential are ongoing. [0067] FIGS. 4 and 5 , indicate the National Cancer Institutes Developmental Therapeutics Program In-Vitro Testing Results for Palmerolide A. FIG. 6 shows the National Cancer Institute (NCI) Developmental Therapeutics Program Dose Response Curves for all cell lines tested for Palmerolide A. In comparison, individual results are shown for Melanoma ( FIG. 7 ), Colon Cancer ( FIG. 8 ) and Renal Cancer ( FIG. 9 ). Example IV Cytotoxicity of Palmerolide C [0068] Palmerolide C, shown below and in FIG. 10 , has the chemical formula C 33 H 49 N 2 O 7 (for NMR data see FIG. 11 ). NCI cytotoxicity is shown in FIG. 12 and FIG. 13 . NCI Dose Response Curves for all cell lines are presented in FIG. 14 . [0000] Example V Cytotoxicity of Palmerolide D [0069] Palmerolide D, shown below and in FIG. 15 , has the chemical formula C 36 H 53 N 2 O 7 . Palmerolide D NMR Data is shown in FIG. 16 . [0000] Example VI Cytotoxicity of Palmerolide [0070] Palmerolide E, shown below and in FIG. 17 , has the chemical formula C 27 H 39 NO 7 (for NMR data see FIG. 18 ). NCI cytotoxicity is shown in FIG. 19 and FIG. 20 . NCI Dose Response Curves for all cell lines are presented in FIG. 21 . [0000] [0071] It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and the scope of the appended claims. In addition, any elements or limitations of any invention or embodiment thereof disclosed herein can be combined with any and/or all other elements or limitations (individually or in any combination) or any other invention or embodiment thereof disclosed herein, and all such combinations are contemplated with the scope of the invention without limitation thereto. [0072] All patents, patent applications, provisional applications, and publications referred to or cited herein are incorporated by reference in their entirety, including all figures and tables, to the extent they are not inconsistent with the explicit teachings of this specification.

The present invention concerns compounds derived from tunicates of the species Synoicum adareanum , as well as to pharmaceutical compositions comprising these compounds and methods of use. Extracts from tunicates show selective toxicity against several different cancer cell lines in the NCI 60 cell line panel. These compounds are useful in the effective treatment of cancers, particularly malignant melanomas, colon cancer, and renal cancer cell lines.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This patent application is a continuation of U.S. patent application Ser. No. 14/803,154, dated Jul. 20, 2015, which is a continuation of U.S. patent application Ser. No. 13/940,217, filed Jul. 11, 2013, now U.S. Pat. No. 9,138,325, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/670,581 filed Jul. 11, 2012, and these applications are incorporated herein by reference in their entireties for all purposes. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to the field of lamina replacement. [0004] 2. Description of the Related Art [0005] Laminectomies, removal of the spinal lamina, are the most common surgical procedures in spinal surgery. Laminectomies are routinely performed in the cervical and lumbar spine to allow decompression of key areas of the spine. [0006] Cervical laminectomies allow decompression of the spinal cord and nerve roots. Patients may present with a radiculopathy (pain in the arms), myelopathy (weakness in arms and legs), or a combination of both. Cervical laminectomies are performed over multiple cervical levels and are an effective technique for cervical decompression and relief of symptoms. Removal of the posterior spinal elements, the cervical lamina, predisposes the patient to develop spinal instability, deformity, and pain. The posterior spinal elements, lamina, allow posterior structural support for the spine and an attachment for the posterior neck muscles. Some surgeons will perform a spinal fusion after cervical laminectomy to prevent spinal deformity. Cervical fusion creates an unnatural state for the neck, however, as the entire fused neck segment is non-mobile. There is a high risk of adjacent level segment instability after cervical fusion since all of the force with motion is transferred to the segment above and below the fusion. [0007] Cervical laminoplasty has been devised for decompression and reconstruction of the cervical lamina, but has certain limitations that have decreased its usefulness in spinal surgery. The primary issue is the technical difficulty of cervical laminoplasty. A “trough” needs to be drilled on one side of the junction of the lamina and lateral mass. This is a technically challenging technique. After a complete trough is formed on one side of the lamina-lateral mass junction, a partial trough is then formed on the opposite side. The lamina is then lifted off the dura and a wedge of bone is secured between the lifted-up side of the lamina Therefore, current cervical laminoplasty techniques allow adequate decompression of only one side of the spinal cord and nerve roots. [0008] Lumbar laminectomies are performed for decompression of the cauda equina and nerve roots. As a large laminectomy defect is created, however, spinal instability can occur. There can also be additional scar formation, as the muscle has to rest directly on the dura after a traditional laminectomy. Some surgeons use hemilaminotomies, where only a portion of the lamina is removed to decompress the nerve roots. However, hemilaminotomies are technically difficult, time consuming, and cannot adequately decompress the bilateral nerve roots and central dura. Lumbar fusions are routinely performed after lumbar laminectomies, but represent a plethora of technical difficulties and predispose the patient to “adjacent level” instability as forces are displaced above or below the fusion. A fusion also involves the placement of large pedicle screws through the pedicle of the vertebral body. Misplacement of the screws has resulted in cerebrospinal fluid (CSF) leaks, nerve injury, and paralysis. [0009] As such, there is still a need for a prosthetic implant for restoring the lamina after laminectomies while providing complete relief for the patient. SUMMARY OF THE INVENTION [0010] The present invention is directed towards a prosthetic implant for restoring lamina after a laminectomy. The implant is generally a lamina-sized construct having a hollow interior. The lamina removed during the laminectomy may be converted to autologous bone that may then be placed inside the hollow interior of the implant. The implant is then secured to the remaining portion of the spine at the site of the laminectomy. An attaching agent, such as one or more plates with screws, may be used to secure the implant to the spine. Over time, the autologous bone inside the hollow interior of the implant will solidify as bone grows through the interior of the implant. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 shows a perspective view of the spine with the lamina removed. [0012] FIG. 2A shows a rear view of the cervical region of the spine with the lamina removed with an embodiment of the present invention in place. [0013] FIG. 2B shows a rear view of the lumbar region of the spine with the lamina removed with an embodiment of the present invention in place. [0014] FIG. 3 shows a perspective view of an embodiment of the present invention with its parts separated and the attachment sites of the spine. [0015] FIG. 4 show a cross-sectional perspective view of an embodiment of the present invention secured to the spine. [0016] FIG. 5 shows a cross-sectional isometric top view of an embodiment of the present invention secured to the spine after bone growth. DETAILED DESCRIPTION [0017] The detailed description set forth below in connection with the appended drawings is intended as a description of presently-preferred embodiments of the invention and is not intended to represent the only forms in which the present invention may be constructed and/or utilized. The description sets forth the functions and the sequence of steps for constructing and operating the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions, features, and sequences may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention. [0018] The present invention represents a novel implant and technique for the restoration of the lamina after cervical decompression or lumbar decompression. As seen in FIG. 1 , when a surgeon performs a cervical or lumbar laminectomy by removing the lamina 102 of a spine 100 , a gap is formed. In one embodiment of the present invention, an appropriately sized lamina replacement implant 200 may then be selected for attachment to the spine 100 on each side 106 of the gap. [0019] This embodiment of the present invention, therefore, includes a lamina replacement implant 200 . As shown in FIG. 2A and FIG. 2B , it may be secured to the spine 100 at the site of the removed lamina The implant 200 is shaped in a way that allows attachment to the spine 100 while providing support for the spine 100 and/or protection for the spinal cord 108 . In a preferred embodiment, the implant 200 has a hollow body having a first arm 202 terminating at a first end 204 , a second arm 206 terminating at a second end 208 , connected together in a mid-section 210 . The hollow body may be made of PEEK (polyether ether ketone) or other suitable biocompatible material. [0020] In the embodiment in FIG. 3 , the body of the implant 200 has a first arm 202 and a second arm 206 , with the first arm 202 and the second arm 206 connected to form the mid-section 210 . In this embodiment, the first arm 202 and second arm 206 are connected in a movable way to allow for adjustments to their orientation. Examples include the use of hinges, pivots, joints, or telescoping features. This allows the implant 200 to be adjusted to fit many of the different sizes of the spine 100 at different spinal levels. Accordingly, one such implant 200 could be adjusted outwardly to fit the largest lumbar spinal level or inwardly to fit a much smaller cervical spinal level so that it may be applicable to many or all of the spinal levels. Alternatively, a larger two-arm implant 200 could be fashioned to fit just the lumbar spinal levels and a smaller two-arm implant could be fashioned to fit just all or a portion of the cervical spinal levels. Once the adjustment has been made such that the ends of the two arms satisfactorily mate with the spine 100 , this particular orientation can be locked in place by a locking mechanism 218 , such as a screw, pin, glue, or any equivalents. The locking mechanism may be made of titanium, solidified bone graft material, or other biocompatible material. The two arms would mate with the lateral mass in the cervical spine and facet/pedicle in the lumbar spine. [0021] In another embodiment, the body of the implant 200 is one piece or even multiple pieces but without a defined hinge or pivot portion. Such an implant 200 could have several mounting holes or slots so as to be able to mount to a range of spinal levels of several different sizes. Alternatively, such an embodiment could involve two flexible arms 202 , 206 or a flexible mid-section 210 . The flexible portion could be elastic such that it tends to spring back to a neutral shape until it is fixed to the spine 100 . Yet a further alternative would be that the flexible portion could be designed to readily plastically deform so that there is no significant tendency of the implant 200 to return to a neutral shape once flexed. [0022] Once the surgeon adjusts the implant 200 and moves it into place, such as in FIGS. 2, 4 and 5 , the surgeon may secure the implant 200 to the spine 100 . This can be done by several different securing means. In the embodiment shown in FIG. 4 , the implant 200 is secured to the spine 100 using plates, braces, or brackets fixed to the implant 200 and/or the spine 100 by screws 214 , 216 Implant screws 214 of appropriate length may attach the plates 212 to the arms 202 , 206 of the implant 200 , and spinal screws 216 of appropriate length may attach the plate 212 to the spine 100 . In one preferred embodiment, the lengths are approximately 6 mm- 8 mm for the cervical region and approximately 12 mm- 14 mm for the lumbar region. In another embodiment, the plates 212 and screws 214 , 216 may comprise titanium or a titanium alloy for their biocompatible properties. In other embodiments, the securing means may instead be a malleable strap, a biodegradable material, or a durable or biodegradable adhesive. [0023] The implant 200 should be attached so as to allow contact between the remaining portions of the exposed spine 100 and a region on or in the implant 200 that comprises a bone graft region 300 that can facilitate bone growth through the implant 200 . In one embodiment, at least a portion of the implant 200 may be hollow. These hollow portions 300 can be fitted securely so any bone graft material 500 will not leak out. In a preferred embodiment, the first and second ends of the arms also comprise bevels to allow the implant to more securely attach to the spine. When that midsection is adjusted, the angle of the bevels may change orientation as well. Because of this, in some embodiments, the mating faces of the arms may also be adjustable, malleable, or realignable so that the bevels are at a correct orientation to securely attach to the lateral mass 106 for ease of mating and alignment with the spine and to better ensure a tight fit therebetween. To further facilitate securement to the spine 100 , the first and second ends may further comprise one or more notches into which remaining portions of the spine are contoured, fitted or wedged. One or more additional buffers, such as linings, gap-filling adhesives, mating gaskets, or cushioning, may be added to prevent any leakages of bone graft material 500 from the secured implant 200 or to better fit and secure the implant to the spine 100 . The spine and/or the ends of the arms may be further shaped to each other's contours to form a more secure attachment. The inclusion of adjustable mating facings further reduces the time and effort required in contouring, fitting, or wedging the implant or spine. [0024] Thus, in one embodiment, a hollow interior 300 of the implant 200 may be filled with bone graft material 500 that is intended to solidify through the implant. As shown in FIG. 5 , the bone graft material 500 may become as strong as bone and provide additional strength for the implant 200 . In one embodiment, after a spinal laminectomy, the removed portions of lamina may be crushed into autologous bone (autograft) and used as bone graft material 500 in the implant 200 . This would aid the implant 200 to solidify over time as bone continues to grow through the implant 200 . Such autologous bone graft material 500 may also decrease the chances that such material will be rejected by the patient's body. Indeed, PEEK implants in spinal surgery, filled with autograft and fitted in the disc space, have shown to produce robust bone growth through the interior where autograft has been placed. As PEEK has modules of elasticity that resemble that of bone, it may be a preferential template for lamina replacement, although other compositions may be used and new compositions are sure to prove useful with advancements in the field. [0025] Alternatively, the bone graft material 500 could be composed of autograft material from other portions of the body, allograft material from the bones of other people (such as cadavers, donors, or stem cell cultures), xenograft material from animals, synthetic replacements, other similar substitutes, or a combination thereof. In one embodiment, the implant uses larger bone pieces or fragments or other bone graft material that may have been pre-solidified or partially solidified before it is implanted into a patient. [0026] In one embodiment, as shown in FIG. 5 , the surgeon may drill into the exposed sections of the spine 100 and fill the void created thereby with bone graft material 500 that is also used to fill adjacent hollow portions 300 of the implant 200 so that new bone formed inside the ends of the implant and the new bone formed inside the drilled void within the adjacent spine can form together, allowing for a more secure bone attachment. The embodiment in FIG. 5 shows a drilled area with rounded edges, but other shapes may be used for stronger securement or greater surface areas. In one embodiment, a drill with a hollow center is used so the drilled area has a peg in the middle for greater surface area to promote bone growth. In another embodiment, several holes are drilled in each lateral mass 106 for increased surface area. Alternatively, the implant 200 may include a solid end mass that approximately mates with the interior surface of the void created in the spine 100 and design with a surface material and/or texture that facilitates bone growth or solidification, such surfaces may include nanostructured regions, including nanotextured and nanoporous regions. The solid end mass may also be a solid nub used for anchoring the implant in the bone. This solid nub can be made from titanium, bone made from bone graft material, or other biocompatible material. [0027] Additionally, the implant portions themselves may be composed of biodegradable materials so that the bone graft material 500 solidifies with the spine 100 and the biodegradable implant later biodegrades ultimately to restore the spinal lamina 102 . [0028] While the present invention has been described with regards to particular embodiments and some of their equivalents, it is recognized that additional variations of the present invention with their functionally equivalent features may be devised without departing from the inventive concept.

A prosthetic implant for restoring lamina after a laminectomy. The implant is generally a lamina-sized construct having a hollow interior. The lamina removed during the laminectomy may be converted to autologous bone that may then be placed inside the hollow interior of the implant. The implant may then be secured to the spine at the site of the laminectomy so that lamina restoration can occur as the hollow interior of the implant solidifies with bone growth.

TECHNICAL FIELD OF THE INVENTION [0001] One or more embodiments of the present invention relate generally to intra-operative refraction or wavefront aberrometry. In particular, one embodiment is related to means to present to a surgeon the histogram and/or confidence level of intra-operative refraction or wavefront aberrometry measurement during a cataract surgery, especially the histogram, and/or confidence level of aphakic refraction and/or the associated intra-ocular lens (IOL) power recommendation. BACKGROUND OF THE INVENTION [0002] A need has been identified in recent years in terms of providing real time intra-operative refraction or wavefront measurement feedback to a surgeon performing a refractive cataract surgery or other vision correction procedures on the eye of a patient. The intra-operative refraction or wavefront measurement, especially one obtained from an aphakic eye when the natural lens of the eye is removed, can help to guide a surgeon better determine the optical power of an IOL (intra-ocular lens) (in terms of sphere power for a monofocal or multi-focal or extended depth of focus IOL or accommodating IOL, and cylinder in addition to sphere if the IOL is a toric IOL or even higher order aberration correction if it is a premium higher order correction IOL). Such an approach has been shown to produce better surgical outcomes. Meanwhile, an intra-operative pseudo-phakic refraction or wavefront measurement can also confirm if a targeted refraction has been achieved to within a certain acceptable tolerance and if not, further adjustment (such as a further rotation of an implanted toric IOL or limbal relaxing incision) can be made to finely tune the refraction. [0003] However, one issue associated with the use of an intra-operative wavefront aberrometer or auto-refractor is that the real time refraction value can vary as a result of many dynamic surgical factors, including the alignment of the patient eye relative to the aberrometer or auto-refractor, patient fixation and angle alpha (angle between the center of the pupil and the visual axis), varying pupil size, the intra-ocular pressure (IOP), the hydration of the incision wound, the tear film, and the pressure exerted on the cornea from eye-lid-opening speculum. With proper control of these dynamic surgical factors and artificial intelligence including refraction confidence calculation to qualify and hence reject disqualified refraction/wavefront data, the variation in the measured refraction can be controlled to a certain range. However, there can still be some variation in the measured refraction when a patient eye is aligned relative to the intra-operative aberrometer or auto-refractor. This is more the case when an eye is aphakic, as an aphakic eye generally has a larger absolute base sphere refraction value simply because the wavefront from an aphakic eye is more divergent than that from an emmetropic eye. As a result, the recommended intra-ocular lens (IOL) power based on the real time aphakic refraction (combined with other biometric parameters) can also change in real time, for example, when the eye is re-aligned. This can cause some confusion to a surgeon in determining what exact IOL power to select for implantation during a cataract surgery. [0004] In light of the above, there is a need in the art for a means to show a surgeon how repeatable a refraction reading is and/or how confident the refraction is. In the aphakic state, this will allow the surgeon to make a more informed decision in terms of selecting a recommended IOL power and in the pseudo-phakic state, this will allow the surgeon to finely tune the final position of an implanted IOL until with higher confidence. [0005] One or more embodiments of the present disclosure satisfy one or more of the above-identified needs in the art. One embodiment is a means to present to a surgeon a histogram of real time refractions at each stage of a refractive cataract surgery, i.e. phakia, aphakia and pseudo-phakia. Another embodiment is to automatically and intra-operatively detect the phase of a cataract surgery (i.e. to intra-operatively determine if a patient eye is phakic, aphakic, or pseudo-phakic). Another embodiment is to display a real-time, dynamic histogram of a recommended IOL power calculated from aphakic refractions together with other biometric parameters of the eye. [0006] One aspect of the present disclosure is to record the occurrence frequency of qualified and/or rounded real time refractions and to display the occurrence frequency distribution or histogram of the refraction data. This will present to the surgeon an information rich display of quantitative refraction instead of a most recently single qualified refraction at one point in time, which may be more variable. Another aspect of the present disclosure is to use phakic biometry measurement results of an eye obtained either pre-operatively or intra-operatively to estimate its aphakic refraction, to use an estimated aphakic refraction to automatically detect the aphakic phase of the eye. Still another aspect is to use intra-operative biometry measurement to determine the cataract surgical phase of an eye. Still another aspect is to use intra-operative Purkinje images to determine the cataract surgical phase of an eye. Still another aspect is to combine real time aphakic refraction with phakic and/or aphakic biometry to calculate an IOL power per a targeted final refraction and to present to a surgeon a dynamic histogram of the IOL power recommendations during the aphakic phase. Still another aspect is to optimize and personalize the IOL power calculation in a regression manner by collecting data over a relatively large number of patients for each surgeon to account for surgeon factors. [0007] Another embodiment of the present disclosure is to display the confidence level of real time intra-operative refraction. One aspect is to calculate a confidence level or value based on an algorithm that takes into account all wavefront and/or aberrometry data qualifiers and to present to a surgeon the confidence level or value as a height or length varying percentage bar. Another aspect is to correlate the confidence percentage value to a color encoded confidence percentage indicator (such as the word “Rx”). In this case, the confidence value can be digitized such that for a certain real time refraction that falls within a certain digitized confidence value range, a certain color selected from a color spectrum is assigned to the real time refraction and is displayed to the surgeon. [0008] Still another embodiment of the disclosure is to combine the calculation of the occurrence frequency or probability distribution of qualified refraction with the confidence level of the refraction to produce a combined confidence weighted histogram and to present this confidence weighted histogram to a surgeon in real time. One aspect is to use the confidence weighted histogram to pick the most steady aphakic refraction, and to use the chosen aphakic refraction to calculate the IOL power. Another aspect is to allow the surgeon the option to display only the refraction histogram and/or the refraction confidence bar and/or the combined confidence weighted refraction histogram to guide the surgery. In particular, at the aphakic phase, the surgeon can select the IOL power based on the live, dynamic IOL power histogram; and at the pseudo-phakic phase, the surgeon can use the live refraction histogram to rotate an implanted toric IOL or to perform a guided limbal relaxing incision. BRIEF DESCRIPTION OF THE DRAWING [0009] FIG. 1 shows a schematic diagram of an embodiment system comprising an intra-operative eye refraction measurement device, a digital processor and a display; [0010] FIG. 2 shows the major steps involved in the presently disclosed means to provide a surgeon the histogram of live refraction; [0011] FIG. 3 shows the major steps involved in the presently disclosed means to display the histogram of live IOL power recommendations; [0012] FIG. 4 shows an example display of an IOL power histogram together with some other parameters as well as a live eye image; [0013] FIG. 5A shows a generic schematic diagram similar to that of FIG. 1 but with the difference in that the intra-operative refraction measurement device can include a camera and/or a biometric parameter measuring sub-module, and the digital processor is configured to automatically detect the phase of the surgery to determine if the eye is phakic or aphakic or pseudo-phakic; [0014] FIG. 5B shows an embodiment in which a sequential wavefront sensor is integrated with an eye camera and an optical coherence based biometric parameter measurement submodule. [0015] FIG. 6 shows the major steps involved in one embodiment to meaningfully and automatically display either a histogram of live refraction or a histogram of IOL power recommendation or both depending on the cataract surgical phase; [0016] FIG. 7 shows an example display similar to that of FIG. 4 but with a confidence percentage bar. DETAILED DESCRIPTION [0017] Intra-operative refraction of a patient eye (or alternatively, a subject eye) undergoing a refractive cataract surgery using an intra-operative refraction measurement device such as a wavefront aberrometer or auto-refractor has been shown to improve the refractive surgical outcome. Traditionally, ophthalmic refraction measurements are done in a snap-shot or single measurement manner (although such a single measurement can involve the averaging of a number of snap shots of measurements). When such a measurement is transferred to intra-operative refraction of a patient eye undergoing a refractive cataract surgery, it tends to hide the variability of the measurement result as the refraction of an eye undergoing a surgery is dependent on a number of dynamic surgical factors, including the alignment of the eye relative to the intra-operative refraction device, the condition of the cornea as well as the condition of the anterior chamber of the eye. In fact, even with the use of a snap-shot refraction measurement device, when a surgeon (or other operator) does multiple intra-operative measurements, the refraction measurement results will most likely vary and this variation can cause confusion to a cataract surgeon, especially if the surgeon relies on aphakic intra-operative refraction to determine the IOL power to be selected. Such variability in the pseudo-phakic phase can also cause confusion to a surgeon if the surgeon relies on intra-operative pseudo-phakic refraction to determine the position of an implanted IOL such as the orientation axis of a toric IOL or the amount of limbal relax incision to neutralize astigmatism. The variability of intra-operative refraction became more evident after real time intra-operative wavefront aberrometers were introduced to the refractive cataract surgery practice. [0018] In accordance with one embodiment of the present disclosure, a real time eye refraction measurement device is coupled to a digital processor and a display. FIG. 1 shows a schematic diagram of such an embodiment, in which a real time intra-operative eye refraction measurement device such as a wavefront sensor or an auto-refractor 102 is coupled to a digital processor 104 and is linked to a display 106 . The digital processor 104 is configured to capture/record intra-operative refraction (or wavefront measurement) and to process the refraction or wavefront data in real time to qualify the data and to reject disqualified data. [0019] The qualification of the real time data can be based on various qualification parameters or qualifiers. One important qualifier is the alignment of a patient eye relative to the refraction measurement device. From a practical point of view, for example, when an eye is aligned to within ±0.1 mm of the refraction measurement device optical axis, the alignment can be considered very good and when the eye is aligned to within ±0.5 mm of the device optical axis, the alignment can be considered still acceptable. Therefore, a threshold of ±0.5 mm can be established as the pass/fail criterion for qualifying or disqualifying the data in terms of eye alignment relative to the refraction measurement device. [0020] Another important qualifier is the uniformity of optical power or energy among different sampled sub-wavefronts. A uniformity ratio can be defined as the relative standard deviation of optical energy or power among different sampled sub-wavefronts, i.e. as standard deviation divided by the average value. As an example, the uniformity ratio threshold can be 6%. The data qualification process will therefore reject any refraction frame data that has a uniformity ratio greater than the threshold. Alternatively, the uniformity qualification parameter can also be defined as an occlusion parameter which is the maximum minus minimum value divided by the average in terms of optical energy or power among different sampled sub-wavefronts. An associated threshold (such as three times that of the uniformity ratio) can also be defined to qualify the refraction data. Note that this qualification process will likely remove data associated with surgical factors that partially block the overall wavefront light beam or reflect the incident light probe beam that travels to a patient eye to create the returned wavefront beam. These surgical factors can include, for example, a surgical tool positioned in the probe beam path, thus reflecting the probe beam back to the refraction measurement device; a surgical tool positioned in the wavefront beam path that partially block and hence attenuate light related to some sub-wavefronts; an air bubble or cortex leftovers inside the anterior chamber or the lens capsule of a patient eye that either absorb(s) or scatter(s) light related to some sub-wavefronts; a blob or puddle of visco-elastic material or irrigation solution left on the cornea of a patient eye that directs away light related to some sub-wavefronts. [0021] Another qualifier is the amount or degree of higher order aberrations. This qualifier can be considered as how good the overall aberrations fit as sphere and cylinder refractive errors. If the fitting is not good, we can consider the overall wavefront as more departed from being characterized as a pure combination of sphere and cylinder refractive errors. The degree of departure of the overall wavefront from a combination of sphere and cylinder refractive errors can be defined as the square root of the summation of the square of the distance of each data point from its expected position on an ellipse that represents a combination of sphere and cylinder. A threshold can be established such that if the degree of departure is above the threshold, the wavefront data will be disqualified. Factors that can increase this qualification value include a surgical tool partially blocking the wavefront, keratoconus, scars on a cornea, air bubbles or cortex leftovers inside an eye, visco-elastic gel on a cornea, and irrigation event. [0022] Still another qualifier is the average prismatic tilt of the overall wavefront. For example, if the averaged overall wavefront tilt is pointing at an angle within 1 degree from the optical axis of the eye refraction measurement device, the prismatic tilt of the overall wavefront can be considered very highly qualified. A threshold of, for example, 11 degree can be set and if one finds that the averaged overall wavefront tilt is pointing at an angle greater than the threshold, the wavefront data can be disqualified. [0023] Still another qualifier is the overall signal strength of the wavefront. If there is no eye under the refraction measurement device, for example, when the device is sending the probe beam directly to the floor of an OR (operating room), the wavefront signal returned from the floor will generally be much weaker than that from a real eye. A signal strength range can therefore be defined that covers the full range over all phases and all pigmentation eyes. When the returned wavefront signal strength is outside this pre-defined range, the data will be disqualified. [0024] Still another qualifier is the steadiness of the wavefront data from one frame to the next. In a transient situation such as the movement of a patient eye, the disturbance of the wavefront by an irrigation event, or the movement of a surgical tool within the wavefront path, the wavefront data received may not be steady, i.e. measured refraction changing more than desired from frame to frame. A threshold can be established to require that the change in the sphere and cylinder value from one frame to the next need to be no more than, for example, ±0.5 diopter. If the change is more than this threshold, the data from both frames will be disqualified. [0025] Note that there can be more qualification parameters. In addition to the qualification of the wavefront data, the digital processor 104 can also be further configured to process the qualified data to produce a real time dynamic histogram of the intra-operative refraction (or wavefront measurement) and to display such a histogram on the display. As time goes on during a particular phase of a cataract surgery (such as the aphakic phase), the histogram will also be updated in real time to reflect how steady a measured refraction with a high occurrence frequency gradually becomes. [0026] As an option, the digital processor 104 can also be configured to digitize the qualified refraction data, for example, in quarter diopter steps, to further limit small variations of the live refraction within a quarter diopter to the same value. [0027] By displaying such a histogram to a surgeon in real time during a cataract surgery, the surgeon can know which refraction value is produced most often by the intra-operative refraction measurement device and hence use that value as the more likely “true” refraction of the patient eye in that surgery phase. [0028] In addition, the digital processor 104 can also be configured to automatically recognize the qualified refraction that has the highest occurrence frequency and directly present this refraction to the surgeon. It can be understood that this refraction may change as the cataract surgery initially enters a phase and will gradually stabilize once the eye is properly prepared and conditioned for refraction measurement and is aligned to the refraction measurement device 102 for a certain alignment holding time. With practice, a surgeon will figure out a reasonable holding time to enable the refraction having the highest occurrence frequency to stabilize. [0029] As an option, the time length for the refraction that will be used to produce the histogram can also be pre-defined such that older qualified refraction data are automatically removed while more current new qualified data are added. The time length can also be personalized for a particular surgeon and be limited to a reasonable and practical value. For example, the time length can be 3 seconds to 10 seconds, during which a surgeon can normally keep the eye position of a patient aligned for a reasonably “reliable” high occurrence frequency refraction to be displayed. [0030] FIG. 2 shows the major steps involved in one embodiment to obtain and present to a surgeon the histogram of live intra-operative refraction. The first step 202 is to capture/record intra-operative refraction or wavefront data. The second step 204 is to process the refraction or wavefront data to reject disqualified data. The third step 206 is to process the qualified historic data and to produce a real time histogram. The fourth step 208 is to display a live refraction histogram on a display. [0031] As an option, instead of displaying the histogram that contains all the qualified refraction values, the last step can be to display digitized refraction that has the highest occurrence frequency or to display only a few digitized refraction values including the one that has the highest occurrence frequency as well as a few surrounding ones (such as one or two on each side) that have occurrence frequencies next to the highest occurrence frequency. [0032] Alternatively and more advantageously, as another embodiment of the present disclosure, instead of being configured to display a continuously updated histogram of real time refraction, the digital processor can be configured to combine the qualified aphakic refraction data with biometric data of the eye obtained either pre-operatively or intra-operatively to calculate a recommended IOL power, to produce a live dynamic histogram of the IOL power recommendation, and to display such a histogram on a display. This will be especially beneficial to a surgeon in terms of helping the surgeon to determine which recommended IOL power to choose for implantation. In general, the recommended IOL power will change as an aphakic eye is initially prepared and aligned to the intra-operative refraction measurement device 102 and the recommended IOL power will stabilized as the aphakic eye is held aligned longer. In practice, after a surgeon has prepared and conditioned an aphakic eye, he/she can align the patient eye and hold the patient head steady for a certain time (for example 3 to 5 seconds) to get a relatively steady recommended IOL power that has the highest occurrence frequency. The surgeon can then select this recommended IOL power or compare this IOL power with that based purely on pre-operative biometry data and select a value of his/her choice such as a value in between these two values. [0033] It should be understood that the term biometric data of an eye can include all anatomical parameters of an eye that can be measured either pre-operatively or intra-operatively. In practice, these parameters can be measured optically and ultrasonically and they include axial length, anterior chamber depth, corneal anterior (K or keratometry values) and posterior profiles, corneal steep meridian and flat meridian axis and power, corneal astigmatism, cornea thickness, aqueous depth, lens thickness, lens anterior and posterior profile, pupil size or diameter, pupil center, white to white distance, iris center, and retina thickness, etc. [0034] The reason why these parameters can be combined with aphakic refraction to better predict an IOL is that without aphakic refraction, one can only indirectly calculate and hence predict the optical power of the cornea using for example, a keratometer or corneal topographer or an OCT or a Pentacam. With aphakic refraction, the optical power of the cornea (in both sphere and cylinder) can be directly measured with higher accuracy. Once the cornea optical power, the axial length of an eye and a targeted final refraction is determined, and the final effective lens position of the IOL is predicted, the IOL power can be calculated. In terms of predicting the effective lens position of an IOL, the prediction is generally highly dependent on a so called A-constant that reflects the property of haptics or arms of a particular IOL and the lens itself, which is manufacturer dependent. Meanwhile, the effective lens position of an IOL is also dependent on the anatomic parameters of an eye and these anatomic or biometric parameters include the white to white distance, the anterior chamber depth and the lens capsule position. Therefore, a combination of aphakic refraction with pre- or intra-operative biometric measurement can result in a better surgical outcome. [0035] It should be noted that all other features that have been discussed with respect to real time refraction can be transferred to real time IOL power recommendation at the aphakic phase. Meanwhile, at the aphakic phase, one can also either configure the digital processor to produce and display a histogram of real time refraction or configure it to produce and display a histogram of real time IOL power recommendation or even configure it to produce and display both a histogram of real time refraction and a histogram of real time IOL power recommendation. [0036] As in the case of refraction, the digital processor 104 can also be configured to digitize the IOL power calculated based on the qualified refraction data and the pre- or intra-op biometry data. For example, the digitization of IOL power recommendation can be in half diopter steps to further limit small variations of the recommended IOL power within half diopter to the same value. In addition, the digital processor 104 can also be configured to automatically recognize the calculated IOL power that has the highest occurrence frequency and directly present this IOL power to the surgeon. [0037] Similarly, as another option, the time length for calculating the IOL power histogram can also be pre-defined such that older IOL power data are automatically removed while more current new IOL power data are added. Again the time length can be personalized for a particular surgeon and be limited to a reasonable and practical value. For example, the time length can be 3 seconds to 10 seconds, during which a surgeon can normally keep the position of the eye of a patient eye aligned steady for a reasonably “steady” IOL power recommendation having the highest occurrence frequency to be displayed. [0038] FIG. 3 shows the major steps involved in the presently disclosed means to display the histogram of live IOL power recommendation at the aphakic phase. The first step 302 is to capture/record intra-operative refraction (or wavefront measurement) data. The second step 304 is to process the data in real time to qualify the data and to reject disqualified data. The third step 306 is to calculate a recommended IOL power based on the qualified aphakic refraction data and pre- or intra-op biometry data. The fourth step 308 is to process the IOL power recommendation data to produce a live dynamic histogram of the recommended IOL power. The fifth step 310 is to display such an IOL power histogram on a display. [0039] As in the case of refraction, optionally, instead of displaying the histogram that contains all the IOL power recommendation values, the last step can be to display only a few (such as 3) digitized IOL powers including the one that has the highest occurrence frequency as well as a few surrounding ones (such as 2 with one on each side) that have their occurrence frequencies next to and on both sides of the highest occurrence frequency. [0040] FIG. 4 shows an example of such an IOL power histogram display together with some other parameters as well as a live eye image. Note that in the right column of the display, there is an IOL power histogram 402 that shows three digitized IOL power recommendations, i.e. 25.0, 25.5 and 26.0 diopters. Associated with each recommended IOL power is a vertical bar with a height that represents the respective relative occurrence frequency or probability. In this case, the most frequently occurred IOL power recommendation is 25.5 diopter. The next most frequently occurred IOL power recommendation is 26.0 diopter. [0041] In addition, as another embodiment, the total number of measurements/IOL calculations that are included in the histogram can be displayed in real time. Note that this value is not shown in FIG. 4 and it can be shown anywhere on the display, but is preferably shown directly on or next to the histogram. [0042] In FIG. 4 , the live display also shows a live eye image 412 ; which eye 413 (left or right) is being operated, the orientation of the eye 414 relative to the surgeon (temporal or superior), a soft fixation light switch 415 (to turn a blinking fixation light on and off), a soft button 416 for capturing one or more snap shot(s) of the current screen print, the phase of surgery 417 (in this case, aphakia); a soft session start/stop button 418 . On the right column, in addition to the histogram 402 , there is a box 401 that shows the pre-op targeted refraction and the type of IOL intended to be used for implantation; the three boxes 404 , 405 and 406 show the latest three qualified and digitized real time refractions together with their respective corresponding IOL power recommendations and the corresponding expected final pseudo-phakic refractions; the bottom box 408 shows the current real time refraction reading together with its corresponding spherical equivalent (SE). Note that this current real time refraction reading can be qualified with a lower qualification or confidence threshold and the values can be rounded to the 0.01 digit of a diopter. [0043] At this point, a question to ask is how the phase of surgery can be determined intra-operatively to ensure the recommended IOL power makes sense, i.e., the refraction value being used for the calculation of the IOL power needs to be that from the aphakic phase. Note that one feature in this disclosure is to automatically and intra-operatively detect the phase of a cataract surgery. [0044] FIG. 5A shows a generic schematic diagram of such a device. Compared to the FIG. 1 , the difference is in that the eye refraction measurement device 502 may contain other eye property measurement submodules and the digital processor is configured to use pre- or intra-operative biometric and/or eye image data and real time refraction data to automatically determine the phase of the eye undergoing a cataract surgery, i.e. from phakia, to aphakia and to pseudo-phakia. [0045] It is well known that there is a relatively big change in the average refraction (i.e. spherical equivalent) of an eye from its phakic phase to its aphakic phase, and also mostly likely from its aphakic to its pseudo-phakic phase (except for the case when the eye is extremely long). In fact, if spherical equivalent is used to gauge the difference, the difference in diopter value from a phakic phase to an aphakic phase of the same eye is of the order of about 10 diopters. In one embodiment of the present disclosure, pre- or intra-operative biometry measurement results and/or pre-operative refraction (or wavefront measurement) data are used to determine an expected refraction of the eye in its phakic phase and aphakic phase, and targeted refraction is used to determine expected pseudo-phakic refraction. Once a cataract surgery starts, qualified real time refraction measurement result is consistently compared with the expected refraction of the eye at different phases. If the qualified real time refraction (such as spherical equivalent) is within a certain tolerance range (for example, ±3.0 D or more preferably a range selectable by an end user from ±0.5 D to ±4.0 D) from the expected phakic refraction (such as the pre-op refraction or a calculated phakic refraction using pure eye biometry data or a combination of these data), the state of the eye can be considered as phakic; if the qualified real time refraction is within a certain tolerance range (for example, ±3.0 D, or more preferably a range selectable by an end user from ±0.5 D to ±4.0 D) from the expected aphakic refraction (such as a value calculated using theoretical vergence formula based on axial eye length and corneal power derived from K-measurements), the state of the eye can be considered as aphakic; and finally, if the qualified real time refraction is within a certain tolerance range (for example, ±3.0 D, or more preferably a range selectable by an end user from ±0.5 D to ±4.0 D) from the targeted refraction after the aphakic phase, the state of the eye can be considered as pseudo-phakic. [0046] Note that the reason for choosing the example of ±3.0 D as one preferred tolerance range is that in most cases, temporary surgical factors such as the hydration of incision wound, the change in the intra-ocular pressure, and the pressure exerted on a cornea from a speculum, will not cause the average refraction of the eye to depart from its expected value by more than approximately ±2.0D. [0047] In some cases like a dense cataract or femto laser cases, either pre-op or intra-op phakic refraction of the eye may be impossible or unreliable due to strong scattering of light by the dense cataract lens or some other strong light scattering regions in the eye such as optical bubbles created by a femto laser. Also, if the eye is extremely long, the difference in refraction between its aphakic phase and its pseudo-phakic phase can be smaller than the tolerance range which can cause an overlap between the expected refraction in the aphakic phase and that in the pseudo-phakic phase. In these cases, using just expected refractions to compare with real time refraction may not be enough to differentiate the phases of a cataract surgery. [0048] As an embodiment, information from real time Purkinje images can be used to help determine the phase. This is because the Purkinje images are very different from one phase to another phase. In fact, the natural lens of an eye is relatively thicker when compared with an artificial intra-ocular lens (IOL) and the refractive index of a natural lens is generally lower than that of an IOL. Therefore, the third and fourth Purkinje images created by the front and back interfaces of a natural lens are less bright and more separated as compared to those of an IOL. Further, in the aphakic phase, due to the fact that there is no natural or artificial lens in the eye, there are only the first and second Purkinje images created by the front and back interfaces of the cornea. In terms of hardware, there is a need for a live eye camera to be associated or coupled to the eye refraction measurement device, and fortunately, this is generally the case as such a camera is needed to guide a surgeon in aligning an eye to the eye refraction measurement device. Note that in FIG. 5A , such a camera 508 is represented by a box linked to the eye refraction measurement device 502 via a dashed line and this camera 508 can be integrated inside the eye refraction measurement device as will be discussed shortly in FIG. 5B . [0049] As still another embodiment, an eye biometric parameter measurement submodule 510 is coupled to or integrated inside the eye refraction measurement device 502 . In FIG. 5A this is shown with the box 510 linked by a dashed line to the box 502 . The submodule 510 can be an optical coherence tomography (OCT) module or simply an optical low coherence reflectometer (OLCR) as will be discussed shortly in more detail in FIG. 5B . The difference between an OCT and an OLCR is that an OCT can perform two dimensional scanning to obtain a three dimensional volumetric data set of optical reflection/scattering information and an OLCR does not do any transverse scanning so it can only obtain optical reflection/scattering information along a single line. However, in terms of intra-operatively obtaining information on whether there is a natural lens, or no lens or an artificial IOL in an eye, both OCT and OLCR can do the job simply because a phakic natural lens is much thicker with less strong reflection/scattering from its optical interfaces than a pseudo-phakic IOL, and meanwhile in the aphakic phase, there is no lens at all. Both OCT and OLCR can hence detect these conditions. Therefore, the digital processor in FIG. 5A can be configured to use either OCT or OLCR obtained information to determine the phase of a cataract surgery. [0050] Note that even though either an OCT or an OLCR can provide the information on the phase of the eye under a cataract surgery, an OCT is preferred because it can also provide information on other anatomic or biometric parameters which is useful in calculating the IOL power as we discussed before. [0051] To illustrate a more specific embodiment, FIG. 5B shows a schematic diagram in which a sequential wavefront sensor is integrated with an eye camera and an optical coherence tomographer (OCT) based biometric parameter measurement submodule. In this illustration, a sequential wavefront sensor 502 is attached to a surgical microscope 500 , and an OCT based eye biometric parameter measurement submodule 510 as well as an eye camera 508 is integrated with the wavefront sensor 502 . [0052] The surgical microscope has its own objective lens 501 . A main beam splitter 561 is positioned below the objective lens 501 to separate and combine visible and infrared light beams. The main beam splitter 561 is transmissive to visible light meant for the microscope 500 and is reflective to near infrared light meant for the wavefront sensor and the camera as well as the biometric parameter measurement submodule. A shield window or shield lens 552 is arranged below the beam splitter 561 and a number flood illumination light sources (such as LEDs) are arranged around the shield to provide flood illumination to the patient eye for the camera to capture a live eye image. [0053] The wavefront sensor module 502 comprises two 4-F relay stages with its light path folded to relay the wavefront from the corneal or pupil plane of a patient eye 599 to a wavefront sampling aperture 518 . The first relay stage comprises a first lens 554 and a second lens 516 and relays the wavefront (with certain optical magnification or demagnification depending on the focal length of the first and second lens) from the corneal or pupil plane to an intermediate image plane where a dynamic transmissive focus variable lens 578 is disposed. This focus variable lens can be used to partially or fully compensate the sphere component of the wavefront or to dynamically change its focus to enable a scanning of the sphere component of the wavefront. [0054] The second relay stage comprises a third lens 540 and a fourth lens 542 and further relays the wavefront from the intermediate plane (where the dynamic transmissive focus variable lens 578 is disposed) to the final wavefront sampling aperture 518 plane. A mega-aperture 577 can be arranged at the first Fourier transform plane to prevent light outside a certain diopter range from entering the rest of the wavefront relay path. A band pass filter 576 can also be arranged in the second relay stage to reject light outside an intended wavefront sensing spectral range from entering the rest of the wavefront relay light path. A MEMS (microelectrical mechanical system) mirror 512 folds the beam path and scans the wavefront sequentially around the aperture 518 so that different sub-wavefronts are sampled. A sub-wavefront focusing lens 520 is positioned next to the sample aperture 518 to focus the sampled sub-wavefronts to a position sensing device 522 . A diffuser (not shown in FIG. 5B ) can be arranged in front of the position sensing device 522 to ensure a certain light spot size on position sensing device 522 . [0055] The OCT based biometric parameter measurement submodule 510 can be based on an optical fiber low coherence interferometer. Light from a low coherence light source (such as a fiber pigtailed superluminescent diode or SLD) 572 is directed to a directional coupler 590 and is split into a sample arm 588 and a reference arm 592 . The reference arm can have a fiber coil that ensures an overall reference optical path length approximately matched to that of the sample arm. Light in the sample arm can be collimated and/or focused and/or scanned. Lens 586 , scanner 582 , lens 584 and scanner 580 are just some exemplary possibilities in terms of manipulating/scanning the sample beam. The sample light beam is sent to a patient eye through a polarization beam splitter (PBS) 574 . Sample light wave returned from the eye (especially by all the eye optical interfaces) that has the original polarization can be collected by the same sample arm optics to recombine with the light wave from the reference arm to create optical low coherence interference and then sent to a detector or a detection module 594 for signal extraction. Sample light from the eye having an orthogonal polarization will be reflected by the PBS 574 to be directed to the wavefront sensor module for wavefront or refraction measurement. [0056] The eye camera module 508 comprises a camera lens 568 and an image sensor 562 . The camera lens 568 can be designed to work in combination with the first lens 554 to form an eye anterior image on the image sensor 562 . An imaging beam splitter 560 can be arranged to reflect light of the flood light spectral band meant for live eye camera imaging to the eye camera module 508 . The spectral band of the SLD can be selected to be different such that light in that spectral band will pass through the beam splitter 560 and be channeled to the rest of the wavefront sensing path. [0057] Note that the wavefront sensor as illustrated in FIGS. 5A and 5B does not have to be a sequential wavefront sensor, it can be any refraction measurement device. The eye biometric parameter measurement device or submodule does not need to be limited to an OCT or OLCR, it can be a scheimpflug camera or even a nuclear magnetic resonance imaging module. The spectral band used for wavefront sensing does not need to be the same as the one used for biometric parameter measurement. In such a case, a WDM (wavelength division multiplexing) fiber coupler can be used to combine and split the two spectral bands of light. [0058] Although auto-detection of the phase of an eye under a cataract surgery is desired, at this moment, it should also be noted that another embodiment of the present disclosure is to allow the surgeon to manually select or interrupt to select the phase so that it can be ensured that the refraction value used for IOL calculation is that from the aphakic phase. [0059] Note also that as still another embodiment, the digital processor 504 can be configured to combine the information provided by either the pre-op biometry and/or refraction data or the intra-op refraction data or the intra-op Purkinje image data or the intra-op biometry data to determine the phase of a cataract surgery. [0060] With the automatic detection of the cataract surgical phase of an eye, the digital processor can be further configured to only display refraction histogram in the phakic phase and pseudo-phakic phases, and to only display IOL power histogram in the aphakic phase or to display both refraction histogram and IOL power histogram in the aphakic phase. [0061] FIG. 6 shows the major steps involved in one embodiment to meaningfully and automatically display either a histogram of intra-operative refraction or a histogram of IOL power recommendation or both. The first step 602 is to automatically determine the phase of an eye under cataract surgery. If the eye is phakic, the next step 604 is to display the histogram of intra-operative refraction in the phakic phase. If the eye is aphakic, the next step 606 is to display the histogram of IOL power recommendation or to display both the histogram of refraction and the histogram of IOL power recommendation. If the eye is pseudo-phakic, the next step 608 is to display the histogram of intra-operative refraction in the pseudo-phakic phase. [0062] As another embodiment of the present disclosure, a confidence level of intra-operative refraction data is calculated and displayed in real time. As will be explained in more detail shortly, the confidence level value can be calculated based on an algorithm that takes into account different qualifiers, including alignment of the eye, wavefront signal strength, the optical energy or power distribution among all sampled sub-wavefronts, the overall average prismatic tilt of all the sampled sub-wavefronts, the amount of higher order aberrations, etc. In one embodiment, the confidence value is associated with the most recent qualified refraction. [0063] In terms of displaying the confidence level or value in real time, one embodiment is to display it as a height or length varying percentage bar; another embodiment is to correlate the confidence percentage value to a color from a rainbow spectrum with the confidence percentage indicator (such as the word “Rx” or the numerical value that shows the refraction) being shown in different colors. In this latter case, the confidence value can be digitized such that for a certain real time refraction that falls within a certain digitized confidence level range, a certain color is assigned to the real time refraction and is displayed to the surgeon. [0064] FIG. 7 is an example live display in which a confidence percentage bar 703 is shown in addition to those pieces of information shown in FIG. 4 . Note that the confidence percentage bar can be arranged anywhere on the live display but is preferred to be next to the current qualified refraction or current IOL power recommendation. In FIG. 7 , the confidence percentage bar 703 is below the histogram 702 and above the most recent qualified refraction. Note that in the aphakic phase, as there is a correspondence between a qualified refraction and an associated IOL power recommendation, therefore, the confidence percentage is also a confidence value for the current IOL power recommendation. [0065] As an alternative, in another embodiment, instead of showing the confidence percentage of the current refraction, the confidence percentage shown can also be that associated with the refraction that has the highest occurrence frequency (i.e. the one having the highest value in the refraction histogram or the one having the highest value in the IOL power histogram). In addition, the confidence percentage bar can also be color coded such that one or more threshold(s) can be established to indicate to a surgeon if the confidence level is high or medium or low. For example, when the confidence value is above 90%, the confidence bar can be in green color, when the confidence value is between 75% and 90%, the confidence bar color can be yellow, when the confidence value is between 50% and 75%, the color of the confidence bar can be orange, and when the confidence value is below 50%, the color can be grey. These color codings can be configured per a surgeon's personalized preference as well. Similar color coding can also be applied to the font color of the refraction and/or IOL power and/or expected final pseudo-phakic refraction values. [0066] In terms of calculating the overall confidence level value, we can assume that the thresholds for different qualifiers have been established and that the refraction data being processed have passed all the qualification thresholds. Then for each qualifier, a range can be defined between a practical good case and a threshold case and a confidence percentage value can be assigned to each qualifier or qualification parameter within the range. The overall confidence level can then be defined as a function of each individual qualifier confidence percentage values such as the average. [0067] For example, consider that the degree of eye alignment relative to the refraction measurement device is a qualifier. From a practical point of view, when the eye is aligned to within ±0.1 mm of the optical axis of the eye refraction measurement device, the confidence level can be considered as 100%. Assume that the qualification threshold is established as when the eye is aligned to within ±0.5 mm of the device optical axis and the corresponding confidence level for this threshold case is 0%. Then for an arbitrary eye alignment that is between the ±0.1 mm case and the ±0.5 mm threshold case, the confidence percentage value can be assumed to be linear or non-linear. In the linear case, if the eye center is 0.2 mm away from the optical axis, the corresponding eye alignment confidence level will be 75% (0.2 mm is three quarter from 0.5 mm over the range between 0.1 mm and 0.5 mm). [0068] Similarly, if the uniformity of optical energy or power distribution among all sampled sub-wavefronts is another qualifier. Then from a practical point of view, when the uniformity ratio (standard deviation divided by the average) is 2%, the uniformity confidence level can be considered 100%. If the uniformity ratio threshold is 6% which corresponds to a uniformity confidence level of 0%, then assuming a linear relationship, a uniformity ratio of, say, 3% will result in a uniformity confidence percentage value of 75% (3% is three quarter away from 6% over the range between 2% and 6%). [0069] We can propagate the same argument to one more qualifier, the average prismatic tilt of the overall wavefront. From a practical point of view, when the average prismatic tilt of the overall wavefront is within 1 degree relative to the optical axis of the refraction measurement device, the confidence level can be considered as 100%. Assuming that the threshold is 11 degree which corresponds to a confidence value of 0%, then for an arbitrary average prismatic tilt of 4 degree, under the assumption of a linear relationship, the corresponding confidence level will be 70% (4 degree is 70% away from 11 degree over the range between 1 degree and 11 degree). [0070] Similar calculations can be applied to other qualifiers, including overall wavefront signal strength, frame to frame refraction difference, and the amount of higher order aberrations, etc. An overall confidence level can be defined as the average of all the individual confidence levels. The overall confidence level can also be defined with different weighting factors depending on the importance of a particular qualifier. [0071] Note that there are many other ways to calculate the confidence level associated with each qualifier and non-linear relationship can be established across the range between a practically good enough case and a threshold case. For example, instead of using a linear relationship across the range, a non-linear relationship such as a square root relationship can be employed. In such as case, a 75% confidence level in the linear relationship case will be equal to SQRT(75%)=86.6% in the non-linear relationship case, and a 36% confidence level in the linear relationship case will be equal to SQRT(36%)=60% in the non-linear relationship case. [0072] Meanwhile, the overall confidence level can also be non-linear in terms of its association with different qualifier's confidence levels. For example, some qualifiers, like the alignment of the eye and the overall prismatic tilt in the aphakic phase can have a higher weighting as compared to other qualifiers such as the amount of higher order aberrations. Therefore, above shown method to calculate the confidence level is only exemplary. [0073] In addition, there can also be a combined consideration of the confidence level and the steadiness of a qualified refraction. One embodiment of the disclosure is to combine the calculation of the occurrence frequency distribution of qualified refractions with the confidence of the corresponding refractions to produce a combined confidence weighted histogram and to display this confidence weighted histogram to a surgeon in real time. Note that in such a case, the modified histogram can show a digitized refraction that is the tallest in the histogram but the refraction may not have the highest occurrence frequency simply because it may have a high confidence level that has been weighted and factored in the histogram. Accordingly, the recommended IOL power can also be modified to factor in the calculation of the occurrence frequency distribution of IOL power and the confidence level associated with that IOL power, and to produce a combined confidence weighted histogram of IOL power recommendation. [0074] Note that these modifications to the histogram can also be optimized over time through regression. Artificial intelligence or neural network can be built in an algorithm for a particular surgeon to automatically adjust the weighting factors of different qualifiers using clinical data collected over a large number of patients and to produce an optimized weighting function that will produce a statistically optimized real time refraction or real time IOL power recommendation, thus leading to a statistically optimized surgical outcome for that particular surgeon. [0075] Note also that all additional features and embodiment variations as mentioned in the refraction and IOL recommendation histogram examples can be applied to the confidence weighted refraction and/or confidence weighted IOL power recommendation cases. For example, automatic detection of the phase of an eye under a cataract surgery can be implemented to determine if a confidence weighted refraction histogram should be displayed (like in phakia and pseudo-phakia) or an associated confidence weighted IOL power recommendation histogram should be displayed (like in aphakia). [0076] In addition, in the aphakic phase, the confidence weighted refraction histogram can also be used to automatically select the most likely “true” aphakic refraction and this selected aphakic refraction can be used to calculate an IOL power using a regression formula that also takes into consideration the biometry data collected pre- or intra-operatively as well as the statistical data collected over a large number of patients. In practice, once a surgeon has conditioned an aphakic eye, and had the eye positioned steady and aligned, overtime, this recommended IOL power will be continuously updated on the display and will gradually become steady to give the surgeon higher confidence in picking the power of an IOL to be implanted. [0077] Note also that the discussion we have had in regard to the power of an IOL can be extended to and should be considered to be extendable to the case of a toric IOL in which the power of the IOL refers to the both the sphere and the cylinder instead of just the sphere of a monofocal IOL. In addition, the extension should also be applied to the selection of more advanced IOLs including extended depth of focus IOLs, bi-focal or tri-focal or multi-focal IOLs, accommodating IOLs (AIOL) and even recommendation of LRI (limbal relaxing incision) or CRI (corneal relaxing incision) in terms of the position and/or direction of the incision and the length of the incision. In other words, the refraction or IOL power recommendation produced by the artificial intelligence of the presently disclosed means can be used to prescribe not only the sphere but also the cylinder and cylinder axis for a refraction procedure. Moreover, since the device being disclosed to measure the optical refraction property of a patient eye is not limited to an auto-refractor but should include a wavefront sensor as well as one or more optical biometry measurement devices, the disclosure should therefore be considered as including higher order aberrations and hence the prescription as exemplified in terms of IOL power recommendation etc. can also be extended to include prescription in correcting higher order aberrations such as coma, trefoil and spherical aberration. [0078] In addition, as one embodiment of the present disclosure, the digital processor can also be configured to store stabilized prescriptions or IOL power recommendations or histogram(s) obtained while the eye is aligned and to keep some of those prescriptions still displayed for a predefined time period even after the eye is moved away from alignment. [0079] In addition, in further embodiments of the present disclosure, the display of information can be configured such that any one of: the real time image of the subject eye; the histogram of occurrence frequency distribution of the qualified refraction values, and/or a histogram of occurrence frequency distribution of IOL powers predicted based on an IOL predictive algorithm that incorporates among other parameters the aphakic refraction of the patient eye in one or more of the phakic, aphakic, or pseudo-phakic phase of the vision correction procedure; the indication of the phase of the vision correction procedure, displaying the pre-operatively determined target refraction value; the one or more of most recent qualified intra-operative refraction values; and sampled wavefronts having overall signal strength higher than one threshold value and/or lower than another threshold value can be displayed in any one of a first portion of the display screen, a second portion of the display screen, a third portion of the display screen, a fourth portion of the display screen, a fifth portion of the display screen, and/or a sixth portion of the display screen. [0080] Although various embodiments that incorporate the teachings of the present invention have been shown and described in detail herein, those skilled in the art can readily devise many other varied embodiments that still incorporate these teachings.

In order to take advantage of the real time nature of intra-operative refraction or wavefront aberrometry, and visually make the history of the measurements apparent to a surgeon, a histogram of frequency vs IOL results calculated from an IOL formula is computed and IOL suggestions being accumulated are displayed in a histogram. One embodiment is a means to present to a surgeon a histogram of intra-operative refractions. Another embodiment is to automatically and intra-operatively detect the aphakic phase of a cataract surgery to display a histogram of a recommended IOL power.

CROSS-REFERENCE [0001] This application claims priority to and is a continuation of U.S. patent application Ser. No. 14/949,675, filed Nov. 23, 2015, which is a continuation of U.S. patent application Ser. No. 14/742,663, filed Jun. 17, 2015, which is a continuation of U.S. patent application Ser. No. 14/184,047, filed Feb. 19, 2014, which is a continuation of U.S. patent application Ser. No. 13/588,966, filed Aug. 17, 2012, which is a continuation of U.S. patent application Ser. No. 11/328,970, filed Jan. 9, 2006, which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 60/643,056, filed Jan. 10, 2005, the full disclosures of which are incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to ophthalmic surgical procedures and systems. BACKGROUND OF THE INVENTION [0003] Cataract extraction is one of the most commonly performed surgical procedures in the world with estimates of 2.5 million cases being performed annually in the United States and 9.1 million cases worldwide. This is expected to increase to approximately 13.3 million cases by 2006 globally. This market is composed of various segments including intraocular lenses for implantation, viscoelastic polymers to facilitate surgical maneuvers, disposable instrumentation including ultrasonic phacoemulsification tips, tubing, and various knives and forceps. Modern cataract surgery is typically performed using a technique termed phacoemulsification in which an ultrasonic tip with an associated water stream for cooling purposes is used to sculpt the relatively hard nucleus of the lens after performance of an opening in the anterior lens capsule termed anterior capsulotomy or more recently capsulorhexis. Following these steps as well as removal of residual softer lens cortex by aspiration methods without fragmentation, a synthetic foldable intraocular lens (IOL's) inserted into the eye through a small incision. This technique is associated with a very high rate of anatomic and visual success exceeding 95% in most cases and with rapid visual rehabilitation. [0004] One of the earliest and most critical steps in the procedure is the performance of capsulorhexis. This step evolved from an earlier technique termed can-opener capsulotomy in which a sharp needle was used to perforate the anterior lens capsule in a circular fashion followed by the removal of a circular fragment of lens capsule typically in the range of 5-8 mm in diameter. This facilitated the next step of nuclear sculpting by phacoemulsification. Due to a variety of complications associated with the initial can-opener technique, attempts were made by leading experts in the field to develop a better technique for removal of the anterior lens capsule preceding the emulsification step. These were pioneered by Neuhann, and Gimbel and highlighted in a publication in 1991 (Gimbel, Neuhann, Development Advantages and Methods of the Continuous Curvilinear Capsulorhexis. Journal of Cataract and Refractive Surgery 1991; 17:110-111, incorporated herein by reference). The concept of the capsulorhexis is to provide a smooth continuous circular opening through which not only the phacoemulsification of the nucleus can be performed safely and easily, but also for easy insertion of the intraocular lens. It provides both a clear central access for insertion, a permanent aperture for transmission of the image to the retina by the patient, and also a support of the IOL inside the remaining capsule that would limit the potential for dislocation. [0005] Using the older technique of can-opener capsulotomy, or even with the continuous capsulorhexis, problems may develop related to inability of the surgeon to adequately visualize the capsule due to lack of red reflex, to grasp it with sufficient security, to tear a smooth circular opening of the appropriate size without radial rips and extensions or technical difficulties related to maintenance of the anterior chamber depth after initial opening, small size of the pupil, or the absence of a red reflex due to the lens opacity. Some of the problems with visualization have been minimized through the use of dyes such as methylene blue or indocyanine green. Additional complications arise in patients with weak zonules (typically older patients) and very young children that have very soft and elastic capsules, which are very difficult to mechanically rupture. [0006] Finally, during the intraoperative surgical procedure, and subsequent to the step of anterior continuous curvilinear capsulorhexis, which typically ranges from 5-7 mm in diameter, and prior to IOL insertion the steps of hydrodis section, hydrodilineation and phaco emulsification occur. These are intended to identify and soften the nucleus for the purposes of removal from the eye. These are the longest and thought to be the most dangerous step in the procedure due to the use of pulses of ultrasound that may lead to inadvertent ruptures of the posterior lens capsule, posterior dislocation of lens fragments, and potential damage anteriorly to the corneal endothelium and/or iris and other delicate intraocular structures. The central nucleus of the lens, which undergoes the most opacification and thereby the most visual impairment, is structurally the hardest and requires special techniques. A variety of surgical maneuvers employing ultrasonic fragmentation and also requiring considerable technical dexterity on the part of the surgeon have evolved, including sculpting of the lens, the so-called “divide and conquer technique” and a whole host of similarly creatively named techniques, such as phaco chop, etc. These are all subject to the usual complications associated with delicate intraocular maneuvers (Gimbel. Chapter 15: Principles of Nuclear PhacoEmulsification. In Cataract Surgery Techniques Complications and Management. 2 nd ed. Edited by Steinert et al. 2004: 153-181, incorporated herein by reference.). [0007] Following cataract surgery one of the principal sources of visual morbidity is the slow development of opacities in the posterior lens capsule, which is generally left intact during cataract surgery as a method of support for the lens, to provide good centration of the IOL, and also as a means of preventing subluxation posteriorly into the vitreous cavity. It has been estimated that the complication of posterior lens capsule opacification occurs in approximately 28-50% of patients (Steinert and Richter. Chapter 44 . In Cataract Surgery Techniques Complications and Management. 2 nd ed. Edited by Steinert et al. 2004: pg. 531-544 and incorporated herein by reference). As a result of this problem, which is thought to occur as a result of epithelial and fibrous metaplasia along the posterior lens capsule centrally from small islands of residual epithelial cells left in place near the equator of the lens, techniques have been developed initially using surgical dissection, and more recently the neodymium YAG laser to make openings centrally in a non-invasive fashion. However, most of these techniques can still be considered relatively primitive requiring a high degree of manual dexterity on the part of the surgeon and the creation of a series of high energy pulses in the range of 1 to 10 mJ manually marked out on the posterior lens capsule, taking great pains to avoid damage to the intraocular lens. The course nature of the resulting opening is illustrated clearly in FIG. 44-10 , pg. 537 of Steinert and Richter, Chapter 44 of In Cataract Surgery Techniques Complications and Management. 2 nd ed (see complete cite above). [0008] What is needed are ophthalmic methods, techniques and apparatus to advance the standard of care of cataract and other ophthalmic pathologies. SUMMARY OF THE INVENTION [0009] The techniques and system disclosed herein provide many advantages. Specifically, rapid and precise openings in the lens capsule and fragmentation of the lens nucleus and cortex is enabled using 3-dimensional patterned laser cutting. The duration of the procedure and the risk associated with opening the capsule and fragmentation of the hard nucleus are reduce, while increasing precision of the procedure. The removal of a lens dissected into small segments is performed using a patterned laser scanning and just a thin aspiration needle. The removal of a lens dissected into small segments is performed using patterned laser scanning and using a ultrasonic emulsifier with a conventional phacoemulsification technique or a technique modified to recognize that a segmented lens will likely be more easily removed (i.e., requiring less surgical precision or dexterity) and/or at least with marked reduction in ultrasonic emulsification power, precision and/or duration. There are surgical approaches that enable the formation of very small and geometrically precise opening(s) in precise locations on the lens capsule, where the openings in the lens capsule would be very difficult if not impossible to form using conventional, purely manual techniques. The openings enable greater precision or modifications to conventional ophthalmic procedures as well as enable new procedures. For example, the techniques described herein may be used to facilitate anterior and/or posterior lens removal, implantation of injectable or small foldable IOLs as well as injection of compounds or structures suited to the formation of accommodating IOLs. [0010] Another procedure enabled by the techniques described herein provides for the controlled formation of a hemi-circular or curvilinear flap in the anterior lens surface. Contrast to conventional procedures which require a complete circle or nearly complete circular cut. Openings formed using conventional, manual capsulorhexis techniques rely primarily on the mechanical shearing properties of lens capsule tissue and uncontrollable tears of the lens capsule to form openings. These conventional techniques are confined to the central lens portion or to areas accessible using mechanical cutting instruments and to varying limited degrees utilize precise anatomical measurements during the formation of the tears. In contrast, the controllable, patterned laser techniques described herein may be used to create a semi-circular capsular flap in virtually any position on the anterior lens surface and in virtually any shape. They may be able to seal spontaneously or with an autologous or synthetic tissue glue or other method. Moreover, the controllable, patterned laser techniques described herein also have available and/or utilize precise lens capsule size, measurement and other dimensional information that allows the flap or opening formation while minimizing impact on surrounding tissue. The flap is not limited only to semi-circular but may be any shape that is conducive to follow on procedures such as, for example, injection or formation of complex or advanced IOL devices or so called injectable polymeric or fixed accommodating IOLs. [0011] The techniques disclosed herein may be used during cataract surgery to remove all or a part of the anterior capsule, and may be used in situations where the posterior capsule may need to be removed intraoperatively, for example, in special circumstances such as in children, or when there is a dense posterior capsular opacity which can not be removed by suction after the nucleus has been removed. In the first, second and third years after cataract surgery, secondary opacification of the posterior lens capsule is common and is benefited by a posterior capsulotomy which may be performed or improved utilizing aspects of the techniques disclosed herein. [0012] Because of the precision and atraumatic nature of incisions formed using the techniques herein, it is believed that new meaning is brought to minimally invasive ophthalmic surgery and lens incisions that may be self healing. [0013] In one aspect, a method of making an incision in eye tissue includes generating a beam of light, focusing the beam at a first focal point located at a first depth in the eye tissue, scanning the beam in a pattern on the eye while focused at the first depth, focusing the beam at a second focal point located at a second depth in the eye tissue different than the first depth, and scanning the beam in the pattern on the eye while focused at the second depth. [0014] In another aspect, a method of making an incision in eye tissue includes generating a beam of light, and passing the beam through a multi-focal length optical element so that a first portion of the beam is focused at a first focal point located at a first depth in the eye tissue and a second portion of the beam is focused at a second focal point located at a second depth in the eye tissue different than first depth. [0015] In yet another aspect, a method of making an incision in eye tissue includes generating a beam of light having at least a first pulse of light and a second pulse of light, and focusing the first and second pulses of light consecutively into the eye tissue, wherein the first pulse creates a plasma at a first depth within the eye tissue, and wherein the second pulse arrives before the plasma disappears and is absorbed by the plasma to extend the plasma in the eye tissue along the beam. [0016] In yet one more aspect, a method of making an incision in eye tissue includes generating a beam of light, and focusing the light into the eye tissue to create an elongated column of focused light within the eye tissue, wherein the focusing includes subjecting the light to at least one of a non-spherical lens, a highly focused lens with spherical aberrations, a curved mirror, a cylindrical lens, an adaptive optical element, a prism, and a diffractive optical element. [0017] In another aspect, a method of removing a lens and debris from an eye includes generating a beam of light, focusing the light into the eye to fragment the lens into pieces, removing the pieces of lens, and then focusing the light into the eye to ablate debris in the eye. [0018] In one more aspect, a method of removing a lens from a lens capsule in an eye includes generating a beam of light, focusing the light into the eye to form incisions in the lens capsule, inserting an ultrasonic probe through the incision and into the lens capsule to break the lens into pieces, removing the lens pieces from the lens capsule, rinsing the lens capsule to remove endothermial cells therefrom, and inserting at least one of a synthetic. foldable intraocular lens or an optically transparent gel into the lens capsule. [0019] In another aspect, an ophthalmic surgical system for treating eye tissue includes a light source for generating a beam of light, a delivery system for focusing the beam onto the eye tissue, a controller for controlling the light source and the delivery system such that the light beam is focused at multiple focal points in the eye tissue at multiple depths within the eye tissue. [0020] In yet another aspect, an ophthalmic surgical system for treating eye tissue includes a light source for generating a beam of light having at least a first pulse of light and a second pulse of light, a delivery system for focusing the beam onto the eye tissue, a controller for controlling the light source and the delivery system such that the first and second pulses of light are consecutively focused onto the eye tissue, wherein the first pulse creates a plasma at a first depth within the eye tissue, and wherein the second pulse is arrives before the plasma disappears and absorbed by the plasma to extend the plasma in the eye tissue along the beam. [0021] In one more aspect, an ophthalmic surgical system for treating eye tissue includes a light source for generating a beam of light, a delivery system for focusing the beam onto the eye tissue, the delivery system including at least one of a non-spherical lens, a highly focused lens with spherical aberrations, a curved mirror, a cylindrical lens, an adaptive optical element, a prism, and a diffractive optical element, and a controller for controlling the light source and the delivery system such that an elongated column of focused light within the eye tissue is created. [0022] Other objects and features of the present invention will become apparent by a review of the specification, claims and appended figures. INCORPORATION BY REFERENCE [0023] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS [0024] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [0025] FIG. 1 is a plan diagram of a system that projects or scans an optical beam into a patient's eye. [0026] FIG. 2 is a diagram of the anterior chamber of the eye and the laser beam producing plasma at the focal point on the lens capsule. [0027] FIG. 3 is a planar view of the iris and lens with a circular pattern for the anterior capsulotomy (capsulorexis). [0028] FIG. 4 is a diagram of the line pattern applied across the lens for OCT measurement of the axial profile of the anterior chamber. [0029] FIG. 5 is a diagram of the anterior chamber of the eye and the 3-dimensional laser pattern applied across the lens capsule. [0030] FIG. 6 is an axially-elongated plasma column produced in the focal zone by sequential application of a burst of pulses ( 1 , 2 , and 3 ) with a delay shorter than the plasma life time. [0031] FIGS. 7A-7B are multi-segmented lenses for focusing the laser beam into 3 points along the same axis. [0032] FIGS. 7C-7D are multi-segmented lenses with co-axial and off-axial segments having focal points along the same axis but different focal distances F 1 , F 2 , F 3 . [0033] FIG. 8 is an axial array of fibers ( 1 , 2 , 3 ) focused with a set of lenses into multiple points ( 1 , 2 , 3 ) and thus producing plasma at different depths inside the tissue ( 1 , 2 , 3 ). [0034] FIG. 9A and FIG. 9B are diagrams illustrating examples of the patterns that can be applied for nucleus segmentation. [0035] FIG. 10A-C is a planar view of some of the combined patterns for segmented capsulotomy and phaco-fragmentation. [0036] FIG. 11 is a plan diagram of one system embodiment that projects or scans an optical beam into a patient's eye. [0037] FIG. 12 is a plan diagram of another system embodiment that projects or scans an optical beam into a patient's eye. [0038] FIG. 13 is a plan diagram of yet another system embodiment that projects or scans an optical beam into a patient's eye. [0039] FIG. 14 is a flow diagram showing the steps utilized in a “track and treat” approach to material removal. [0040] FIG. 15 is a flow diagram showing the steps utilized in a “track and treat” approach to material removal that employs user input. [0041] FIG. 16 is a perspective view of a transverse focal zone created by an anamorphic optical scheme. [0042] FIGS. 17A-17C are perspective views of an anamorphic telescope configuration for constructing an inverted Keplerian telescope. [0043] FIG. 18 is a side view of prisms used to extend the beam along a single meridian. [0044] FIG. 19 is a top view illustrating the position and motion of a transverse focal volume on the eye lens. [0045] FIG. 20 illustrates fragmentation patterns of an ocular lens produced by one embodiment of the present invention. [0046] FIG. 21 illustrates circular incisions of an ocular lens produced by one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0047] The present invention can be implemented by a system that projects or scans an optical beam into a patient's eye 1 , such as the system shown in FIG. 1 . The system includes a light source 10 (e.g. laser, laser diode, etc.), which may be controlled by control electronics 12 , via an input and output device 14 , to create optical beam 11 (either cw or pulsed). Control electronics 12 may be a computer, microcontroller, etc. Scanning may be achieved by using one or more moveable optical elements (e.g. lenses, gratings, or as shown in FIG. 1 a mirror(s) 16 ) which also may be controlled by control electronics 12 , via input and output device 14 . Mirror 16 may be tilted to deviate the optical beam 11 as shown in FIG. 1 , and direct beam 11 towards the patient's eye 1 . An optional ophthalmic lens 18 can be used to focus the optical beam 11 into the patient's eye 1 . The positioning and character of optical beam 11 and/or the scan pattern it forms on the eye may be further controlled by use of an input device 20 such as a joystick, or any other appropriate user input device. [0048] Techniques herein include utilizing a light source 10 such as a surgical laser configured to provide one or more of the following parameters: [0049] 1) pulse energy up to 1 p repetition rate up to 1 MHz, pulse duration <1 ps [0050] 2) pulse energy up to 10 p rep. rate up to 100 kHz, pulse duration <1 ps. [0051] 3) Pulse energy up to 1000 p, rep rate up to 1 kHz, pulse duration <3 ps. [0052] Additionally, the laser may use wavelengths in a variety of ranges including in the near-infrared range: 800-1100 nm. In one aspect, near-infrared wavelengths are selected because tissue absorption and scattering is reduced. Additionally, a laser can be configured to provide low energy ultrashort pulses of near-infrared radiation with pulse durations below 10 ps or below 1 ps, alone or in combination with pulse energy not exceeding 100 p, at high repetition rate including rates above 1 kHz, and above 10 kHz. [0053] Short pulsed laser light focused into eye tissue 2 will produce dielectric breakdown at the focal point, rupturing the tissue 2 in the vicinity of the photo-induced plasma (see FIG. 2 ). The diameter d of the focal point is given by d=λF/D b , where F is the focal length of the last focusing element, D b is the beam diameter on the last lens, and λ is the wavelength. For a focal length F=160 mm, beam diameter on the last lens D b =10 mm, and wavelength λ=1.04 um, the focal spot diameter will be d≈λ/(2·NA)≈λF/D b =15 μm, where the numerical aperture of the focusing optics, NA≈D b /(2F). [0054] To provide for continuous cutting, the laser spots should not be separated by more than a width of the crater produced by the laser pulse in tissue. Assuming the rupture zone being R=15 μm (at low energies ionization might occur in the center of the laser spot and not expand to the full spot size), and assuming the maximal diameter of the capsulotomy circle being D c =8 mm, the number of required pulses will be: N=πD c /R=1675 to provide a circular cut line 22 around the circumference of the eye lens 3 as illustrated in FIG. 3 . For smaller diameters ranging from 5-7 mm, the required number of pulses would be less. If the rupture zone were larger (e.g. 50 μm), the number of pulses would drop to N=503. [0055] To produce an accurate circular cut, these pulses should be delivered to tissue over a short eye fixation time. Assuming the fixation time t=0.2 s, laser repetition rate should be: r=N/t=8.4 kHz. If the fixation time were longer, e.g. 0.5 s, the required rep. rate could be reduced to 3.4 kHz. With a rupture zone of 50 μm the rep. rate could further drop to 1 kHz. [0056] Threshold radiant exposure of the dielectric breakdown with 4 ns pulses is about Φ=100 J/cm 2 . With a focal spot diameter being d=15 μm, the threshold pulse energy will be E th =Φ*πd 2 /4=176 μJ. For stable and reproducible operation, pulse energy should exceed the threshold by at least a factor of 2, so pulse energy of the target should be E b =352 μJ. The creation of a cavitation bubble might take up to 10% of the pulse energy, i.e. E b =35 μJ. This corresponds to a bubble diameter [0000] d b = 6  E b π   P a 3 = 48   µm . [0057] The energy level can be adjusted to avoid damage to the corneal endothelium. As such, the threshold energy of the dielectric breakdown could be minimized by reducing the pulse duration, for example, in the range of approximately 0.1-1 ps. Threshold radiant exposure, Φ, for dielectric breakdown for 100 fs is about Φ=2 J/cm 2 ; for 1 ps it is Φ=2.5 J/cm 2 . Using the above pulse durations, and a focal spot diameter d=15 μm, the threshold pulse energies will be E th =Φ*πd 2 /4=3.5 and 4.4 μJ for 100 fs and 1 ps pulses, respectively. The pulse energy could instead be selected to be a multiple of the threshold energy, for example, at least a factor of 2. If a factor of 2 is used, the pulse energies on the target would be E th =7 and 9 μJ, respectively. These are only two examples. Other pulse energy duration times, focal spot sizes and threshold energy levels are possible and are within the scope of the present invention. [0058] A high repetition rate and low pulse energy can be utilized for tighter focusing of the laser beam. In one specific example, a focal distance of F=50 mm is used while the beam diameter remains D b =10 mm, to provide focusing into a spot of about 4 μm in diameter. Aspherical optics can also be utilized. An 8 mm diameter opening can be completed in a time of 0.2 s using a repetition rate of about 32 kHz. [0059] The laser 10 and controller 12 can be set to locate the surface of the capsule and ensure that the beam will be focused on the lens capsule at all points of the desired opening. Imaging modalities and techniques described herein, such as for example, Optical Coherence Tomography (OCT) or ultrasound, may be used to determine the location and measure the thickness of the lens and lens capsule to provide greater precision to the laser focusing methods, including 2D and 3D patterning. Laser focusing may also be accomplished using one or more methods including direct observation of an aiming beam, Optical Coherence Tomography (OCT), ultrasound, or other known ophthalmic or medical imaging modalities and combinations thereof. [0060] As shown in FIG. 4 , OCT imaging of the anterior chamber can be performed along a simple linear scan 24 across the lens using the same laser and/or the same scanner used to produce the patterns for cutting. This scan will provide information about the axial location of the anterior and posterior lens capsule, the boundaries of the cataract nucleus, as well as the depth of the anterior chamber. This information may then be loaded into the laser 3-D scanning system, and used to program and control the subsequent laser assisted surgical procedure. The information may be used to determine a wide variety of parameters related to the procedure such as, for example, the upper and lower axial limits of the focal planes for cutting the lens capsule and segmentation of the lens cortex and nucleus, the thickness of the lens capsule among others. The imaging data may be averaged across a 3-line pattern as shown in FIG. 9 . [0061] An example of the results of such a system on an actual human crystalline lens is shown in FIG. 20 . A beam of 10 μJ, 1 ps pulses delivered at a pulse repetition rate of 50 kHz from a laser operating at a wavelength of 1045 nm was focused at NA=0.05 and scanned from the bottom up in a pattern of 4 circles in 8 axial steps. This produced the fragmentation pattern in the ocular lens shown in FIG. 20 . FIG. 21 shows in detail the resultant circular incisions, which measured ˜10 μm in diameter, and ˜100 μm in length. [0062] FIG. 2 illustrates an exemplary illustration of the delineation available using the techniques described herein to anatomically define the lens. As can be seen in FIG. 2 , the capsule boundaries and thickness, the cortex, epinucleus and nucleus are determinable. It is believed that OCT imaging may be used to define the boundaries of the nucleus, cortex and other structures in the lens including, for example, the thickness of the lens capsule including all or a portion of the anterior or posterior capsule. In the most general sense, one aspect of the present invention is the use of ocular imaging data obtained as described herein as an input into a laser scanning and/or pattern treatment algorithm or technique that is used to as a guide in the application of laser energy in novel laser assisted ophthalmic procedures. In fact, the imaging and treatment can be performed using the same laser and the same scanner. While described for use with lasers, other energy modalities may also be utilized. [0063] It is to be appreciated that plasma formation occurs at the waist of the beam. The axial extent of the cutting zone is determined by the half-length L of the laser beam waist, which can be expressed as: L˜λ/(4·NA 2 )=dF/D b . Thus the lower the NA of the focusing optics, the longer waist of the focused beam, and thus a longer fragmentation zone can be produced. For F=160 mm, beam diameter on the last lens D b =10 mm, and focal spot diameter d=15 μm, the laser beam waist half-length L would be 240 μm. [0064] With reference to FIG. 5 , a three dimensional application of laser energy 26 can be applied across the capsule along the pattern produced by the laser-induced dielectric breakdown in a number of ways such as, for example: [0065] 1) Producing several circular or other pattern scans consecutively at different depths with a step equal to the axial length of the rupture zone. Thus, the depth of the focal point (waist) in the tissue is stepped up or down with each consecutive scan. The laser pulses are sequentially applied to the same lateral pattern at different depths of tissue using, for example, axial scanning of the focusing elements or adjusting the optical power of the focusing element while, optionally, simultaneously or sequentially scanning the lateral pattern. The adverse result of laser beam scattering on bubbles, cracks and/or tissue fragments prior to reaching the focal point can be avoided by first producing the pattern/focusing on the maximal required depth in tissue and then, in later passes, focusing on more shallow tissue spaces. Not only does this “bottom up” treatment technique reduce unwanted beam attenuation in tissue above the target tissue layer, but it also helps protect tissue underneath the target tissue layer. By scattering the laser radiation transmitted beyond the focal point on gas bubbles, cracks and/or tissue fragments which were produced by the previous scans, these defects help protect the underlying retina. Similarly, when segmenting a lens, the laser can be focused on the most posterior portion of the lens and then moved more anteriorly as the procedure continues. [0066] 2) Producing axially-elongated rupture zones at fixed points by: [0067] a) Using a sequence of 2-3 pulses in each spot separated by a few ps. Each pulse will be absorbed by the plasma 28 produced by the previous pulse and thus will extend the plasma 28 upwards along the beam as illustrated in FIG. 6A . In this approach, the laser energy should be 2 or 3 times higher, i.e. 20-30 μJ. Delay between the consecutive pulses should be longer than the plasma formation time (on the order of 0.1 ps) but not exceed the plasma recombination time (on the order of nanoseconds) [0068] b) Producing an axial sequence of pulses with slightly different focusing points using multiple co-axial beams with different pre-focusing or multifocal optical elements. This can be achieved by using multi-focal optical elements (lenses, mirrors, diffractive optics, etc.). For example, a multi-segmented lens 30 can be used to focus the beam into multiple points (e.g. three separate points) along the same axis, using for example co-axial (see FIGS. 7A-7C ) or off-coaxial (see FIG. 7D ) segments to produce varying focal lengths (e.g. F 1 , F 2 , F 3 ). The multi-focal element 30 can be co-axial, or off-axis-segmented, or diffractive. Co-axial elements may have more axially-symmetric focal points, but will have different sizes due to the differences in beam diameters in each segment. Off-axial elements might have less symmetric focal points but all the elements can produce the foci of the same sizes. [0069] c) Producing an elongated focusing column (as opposed to just a discrete number of focal points) using: (1) non-spherical (aspherical) optics, or (2) utilizing spherical aberrations in a lens with a high F number, or (3) diffractive optical element (hologram). [0070] d) Producing an elongated zone of ionization using multiple optical fibers. For example, an array of optical fibers 32 of different lengths can be imaged with a set of lenses 34 into multiple focal points at different depths inside the tissue as shown in FIG. 8 . [0071] Patterns of Scanning: [0072] For anterior and posterior capsulotomy, the scanning patterns can be circular and spiral, with a vertical step similar to the length of the rupture zone. For segmentation of the eye lens 3 , the patterns can be linear, planar, radial, radial segments, circular, spiral, curvilinear and combinations thereof including patterning in two and/or three dimensions. Scans can be continuous straight or curved lines, or one or more overlapping or spaced apart spots and/or line segments. Several scan patterns 36 are illustrated in FIGS. 9A and 9B , and combinations of scan patterns 38 are illustrated in FIGS. 10A-10C . Beam scanning with the multifocal focusing and/or patterning systems is particularly advantageous to successful lens segmentation since the lens thickness is much larger than the length of the beam waist axial. In addition, these and other 2D and 3D patterns may be used in combination with OCT to obtain additional imaging, anatomical structure or make-up (i.e., tissue density) or other dimensional information about the eye including but not limited to the lens, the cornea, the retina and as well as other portions of the eye. [0073] The exemplary patterns allow for dissection of the lens cortex and nucleus into fragments of such dimensions that they can be removed simply with an aspiration needle, and can be used alone to perform capsulotomy. Alternatively, the laser patterning may be used to pre-fragment or segment the nucleus for later conventional ultrasonic phacoemulsification. In this case however, the conventional phacoemulsification would be less than a typical phacoemulsification performed in the absence of the inventive segmenting techniques because the lens has been segmented. As such, the phacoemulsification procedure would likely require less ultrasonic energy to be applied to the eye, allowing for a shortened procedure or requiring less surgical dexterity. [0074] Complications due to the eye movements during surgery can be reduced or eliminated by performing the patterned laser cutting very rapidly (e.g. within a time period that is less than the natural eye fixation time). Depending on the laser power and repetition rate, the patterned cutting can be completed between 5 and 0.5 seconds (or even less), using a laser repetition rate exceeding 1 kHz. [0075] The techniques described herein may be used to perform new ophthalmic procedures or improve existing procedures, including anterior and posterior capsulotomy, lens fragmentation and softening, dissection of tissue in the posterior pole (floaters, membranes, retina), as well as incisions in other areas of the eye such as, but not limited to, the sclera and iris. [0076] Damage to an IOL during posterior capsulotomy can be reduced or minimized by advantageously utilizing a laser pattern initially focused beyond the posterior pole and then gradually moved anteriorly under visual control by the surgeon alone or in combination with imaging data acquired using the techniques described herein. [0077] For proper alignment of the treatment beam pattern, an alignment beam and/or pattern can be first projected onto the target tissue with visible light (indicating where the treatment pattern will be projected. This allows the surgeon to adjust the size, location and shape of the treatment pattern. Thereafter, the treatment pattern can be rapidly applied to the target tissue using an automated 3 dimensional pattern generator (in the control electronics 12 ) by a short pulsed cutting laser having high repetition rate. [0078] In addition, and in particular for capsulotomy and nuclear fragmentation, an automated method employing an imaging modality can be used, such as for example, electro-optical, OCT, acoustic, ultrasound or other measurement, to first ascertain the maximum and minimum depths of cutting as well as the size and optical density of the cataract nucleus. Such techniques allow the surgeon account for individual differences in lens thickness and hardness, and help determine the optimal cutting contours in patients. The system for measuring dimensions of the anterior chamber using OCT along a line, and/or pattern (2D or 3D or others as described herein) can be integrally the same as the scanning system used to control the laser during the procedure. As such, the data including, for example, the upper and lower boundaries of cutting, as well as the size and location of the nucleus, can be loaded into the scanning system to automatically determine the parameters of the cutting (i.e., segmenting or fracturing) pattern. Additionally, automatic measurement (using an optical, electro-optical, acoustic, or OCT device, or some combination of the above) of the absolute and relative positions and/or dimensions of a structure in the eye (e.g. the anterior and posterior lens capsules, intervening nucleus and lens cortex) for precise cutting, segmenting or fracturing only the desired tissues (e.g. lens nucleus, tissue containing cataracts, etc.) while minimizing or avoiding damage to the surrounding tissue can be made for current and/or future surgical procedures. Additionally, the same ultrashort pulsed laser can be used for imaging at a low pulse energy, and then for surgery at a high pulse energy. [0079] The use of an imaging device to guide the treatment beam may be achieved many ways, such as those mentioned above as well as additional examples explained next (which all function to characterize tissue, and continue processing it until a target is removed). For example, in FIG. 11 , a laser source LS and (optional) aiming beam source AIM have outputs that are combined using mirror DM 1 (e.g. dichroic mirror). In this configuration, laser source LS may be used for both therapeutics and diagnostics. This is accomplished by means of mirror M 1 which serves to provide both reference input R and sample input S to an OCT Interferometer by splitting the light beam B (centerlines shown) from laser source LS. Because of the inherent sensitivity of OCT Interferometers, mirror M 1 may be made to reflect only a small portion of the delivered light. Alternatively, a scheme employing polarization sensitive pickoff mirrors may be used in conjunction with a quarter wave plate (not shown) to increase the overall optical efficiency of the system. Lens L 1 may be a single element or a group of elements used to adjust the ultimate size or location along the z-axis of the beam B disposed to the target at point P. When used in conjunction with scanning in the X & Y axes, this configuration enables 3-dimensional scanning and/or variable spot diameters (i.e. by moving the focal point of the light along the z-axis). [0080] In this example, transverse (XY) scanning is achieved by using a pair of orthogonal galvanometric mirrors G 1 & G 2 which may provide 2-dimensional random access scanning of the target. It should be noted that scanning may be achieved in a variety of ways, such as moving mirror M 2 , spinning polygons, translating lenses or curved mirrors, spinning wedges, etc. and that the use of galvanometric scanners does not limit the scope of the overall design. After leaving the scanner, light encounters lens L 2 which serves to focus the light onto the target at point P inside the patient's eye EYE. An optional ophthalmic lens OL may be used to help focus the light. Ophthalmic lens OL may be a contact lens and further serve to dampen any motion of eye EYE, allowing for more stable treatment. Lens L 2 may be made to move along the z-axis in coordination with the rest of the optical system to provide for 3-dimensional scanning, both for therapy and diagnosis. In the configuration shown, lens L 2 ideally is moved along with the scanner G 1 & G 2 to maintain telecentricity. With that in mind, one may move the entire optical assembly to adjust the depth along the z-axis. If used with ophthalmic lens OL, the working distance may be precisely held. A device such as the Thorlabs EAS504 precision stepper motor can be used to provide both the length of travel as well as the requisite accuracy and precision to reliably image and treat at clinically meaningful resolutions. As shown it creates a telecentric scan, but need not be limited to such a design. [0081] Mirror M 2 serves to direct the light onto the target, and may be used in a variety of ways. Mirror M 2 could be a dichroic element that the user looks through in order to visualize the target directly or using a camera, or may be made as small as possible to provide an opportunity for the user to view around it, perhaps with a binocular microscope. If a dichroic element is used, it may be made to be photopically neutral to avoid hindering the user's view. An apparatus for visualizing the target tissue is shown schematically as element V, and is preferably a camera with an optional light source for creating an image of the target tissue. The optional aiming beam AIM may then provide the user with a view of the disposition of the treatment beam, or the location of the identified targets. To display the target only, AIM may be pulsed on when the scanner has positioned it over an area deemed to be a target. The output of visualization apparatus V may be brought back to the system via the input/output device 10 and displayed on a screen, such as a graphical user interface GUI. In this example, the entire system is controlled by the controller CPU, and data moved through input/output device 10 . Graphical user interface GUI may be used to process user input, and display the images gathered by both visualization apparatus V and the OCT interferometer. There are many possibilities for the configuration of the OCT interferometer, including time and frequency domain approaches, single and dual beam methods, etc, as described in U.S. Pat. Nos. 5,748,898; 5,748,352; 5,459,570; 6,111,645; and 6,053,613 (which are incorporated herein by reference. [0082] Information about the lateral and axial extent of the cataract and localization of the boundaries of the lens capsule will then be used for determination of the optimal scanning pattern, focusing scheme, and laser parameters for the fragmentation procedure. Much if not all of this information can be obtained from visualization of the target tissue. For example, the axial extent of the fragmentation zone of a single pulse should not exceed the distance between (a) the cataract and the posterior capsule, and (b) the anterior capsule and the corneal endothelium. In the cases of a shallow anterior chamber and/or a large cataract, a shorter fragmentation zone should be selected, and thus more scanning planes will be required. Conversely, for a deep anterior chamber and/or a larger separation between the cataract and the posterior capsule a longer fragmentation zone can be used, and thus less planes of scanning will be required. For this purpose an appropriate focusing element will be selected from an available set. Selection of the optical element will determine the width of the fragmentation zone, which in turn will determine the spacing between the consecutive pulses. This, in turn, will determine the ratio between the scanning rate and repetition rate of the laser pulses. In addition, the shape of the cataract will determine the boundaries of the fragmentation zone and thus the optimal pattern of the scanner including the axial and lateral extent of the fragmentation zone, the ultimate shape of the scan, number of planes of scanning, etc. [0083] FIG. 12 shows an alternate embodiment in which the imaging and treatment sources are different. A dichroic mirror DM 2 has been added to the configuration of FIG. 11 to combine the imaging and treatment light, and mirror M 1 has been replaced by beam splitter BS which is highly transmissive at the treatment wavelength, but efficiently separates the light from the imaging source SLD for use in the OCT Interferometer. Imaging source SLD may be a superluminescent diode having a spectral output that is nominally 50 nm wide, and centered on or around 835 nm, such as the SuperLum SLD-37. Such a light source is well matched to the clinical application, and sufficiently spectrally distinct from the treatment source, thus allowing for elements DM and BS to be reliably fabricated without the necessarily complicated and expensive optical coatings that would be required if the imaging and treatment sources were closer in wavelength. [0084] FIG. 13 shows an alternate embodiment incorporating a confocal microscope CM for use as an imaging system. In this configuration, mirror M 1 reflects a portion of the backscattered light from beam B into lens L 3 . Lens L 3 serves to focus this light through aperture A (serving as a spatial filter) and ultimately onto detector D. As such, aperture A and point P are optically conjugate, and the signal received by detector D is quite specific when aperture A is made small enough to reject substantially the entire background signal. This signal may thus be used for imaging, as is known in the art. Furthermore, a fluorophore may be introduced into the target to allow for specific marking of either target or healthy tissue. In this approach, the ultrafast laser may be used to pump the absorption band of the fluorophore via a multiphoton process or an alternate source (not shown) could be used in a manner similar to that of FIG. 12 . [0085] FIG. 14 is a flowchart outlining the steps utilized in a “track and treat” approach to material removal. First an image is created by scanning from point to point, and potential targets identified. When the treatment beam is disposed over a target, the system can transmit the treatment beam, and begin therapy. The system may move constantly treating as it goes, or dwell in a specific location until the target is fully treated before moving to the next point. [0086] The system operation of FIG. 14 could be modified to incorporate user input. As shown in FIG. 15 , a complete image is displayed to the user, allowing them to identify the target(s). Once identified, the system can register subsequent images, thus tracking the user defined target(s). Such a registration scheme may be implemented in many different ways, such as by use of the well known and computationally efficient Sobel or Canny edge detection schemes. Alternatively, one or more readily discernable marks may be made in the target tissue using the treatment laser to create a fiduciary reference without patient risk (since the target tissue is destined for removal). [0087] In contrast to conventional laser techniques, the above techniques provide (a) application of laser energy in a pattern, (b) a high repetition rate so as to complete the pattern within the natural eye fixation time, (c) application of sub-ps pulses to reduce the threshold energy, and (d) the ability to integrate imaging and treatment for an automated procedure. [0088] Laser Delivery System [0089] The laser delivery system in FIG. 1 can be varied in several ways. For example, the laser source could be provided onto a surgical microscope, and the microscope's optics used by the surgeon to apply the laser light, perhaps through the use of a provided console. Alternately, the laser and delivery system would be separate from the surgical microscope and would have an optical system for aligning the aiming beam for cutting. Such a system could swing into position using an articulating arm attached to a console containing the laser at the beginning of the surgery, and then swing away allowing the surgical microscope to swing into position. [0090] The pattern to be applied can be selected from a collection of patterns in the control electronics 12 , produced by the visible aiming beam, then aligned by the surgeon onto the target tissue, and the pattern parameters (including for example, size, number of planar or axial elements, etc.) adjusted as necessary for the size of the surgical field of the particular patient (level of pupil dilation, size of the eye, etc.). Thereafter, the system calculates the number of pulses that should be applied based on the size of the pattern. When the pattern calculations are complete, the laser treatment may be initiated by the user (i.e., press a pedal) for a rapid application of the pattern with a surgical laser. [0091] The laser system can automatically calculate the number of pulses required for producing a certain pattern based on the actual lateral size of the pattern selected by surgeon. This can be performed with the understanding that the rupture zone by the single pulse is fixed (determined by the pulse energy and configuration of the focusing optics), so the number of pulses required for cutting a certain segment is determined as the length of that segment divided by the width of the rupture zone by each pulse. The scanning rate can be linked to the repetition rate of the laser to provide a pulse spacing on tissue determined by the desired distance. The axial step of the scanning pattern will be determined by the length of the rupture zone, which is set by the pulse energy and the configuration of the focusing optics. [0092] Fixation Considerations [0093] The methods and systems described herein can be used alone or in combination with an aplanatic lens (as described in, for example, the U.S. Pat. No. 6,254,595 patent, incorporated herein by reference) or other device to configure the shape of the cornea to assist in the laser methods described herein. A ring, forceps or other securing means may be used to fixate the eye when the procedure exceeds the normal fixation time of the eye. Regardless whether an eye fixation device is used, patterning and segmenting methods described herein may be further subdivided into periods of a duration that may be performed within the natural eye fixation time. [0094] Another potential complication associated with a dense cutting pattern of the lens cortex is the duration of treatment: If a volume of 6×6×4 mm=144 mm 3 of lens is segmented, it will require N=722,000 pulses. If delivered at 50 kHz, it will take 15 seconds, and if delivered at 10 kHz it will take 72 seconds. This is much longer than the natural eye fixation time, and it might require some fixation means for the eye. Thus, only the hardened nucleus may be chosen to be segmented to ease its removal. Determination of its boundaries with the OCT diagnostics will help to minimize the size of the segmented zone and thus the number of pulses, the level of cumulative heating, and the treatment time. If the segmentation component of the procedure duration exceeds the natural fixation time, then the eye may be stabilized using a conventional eye fixation device. [0095] Thermal Considerations [0096] In cases where very dense patterns of cutting are needed or desired, excess accumulation of heat in the lens may damage the surrounding tissue. To estimate the maximal heating, assume that the bulk of the lens is cut into cubic pieces of 1 mm in size. If tissue is dissected with E 1 =10 uJ pulses fragmenting a volume of 15 um in diameter and 200 um in length per pulse, then pulses will be applied each 15 um. Thus a 1×1 mm plane will require 66×66=4356 pulses. The 2 side walls will require 2×66×5=660 pulses, thus total N=5016 pulses will be required per cubic mm of tissue. Since all the laser energy deposited during cutting will eventually be transformed into heat, the temperature elevation will be DT=(E 1 *N)/pcV=50.16 mJ/(4.19 mJ/K)=12 K. This will lead to maximal temperature T=37+12° C.=49° C. This heat will dissipate in about one minute due to heat diffusion. Since peripheral areas of the lens will not be segmented (to avoid damage to the lens capsule) the average temperature at the boundaries of the lens will actually be lower. For example, if only half of the lens volume is fragmented, the average temperature elevation at the boundaries of the lens will not exceed 6° C. (T=43° C.) and on the retina will not exceed 0.1 C. Such temperature elevation can be well tolerated by the cells and tissues. However, much higher temperatures might be dangerous and should be avoided. [0097] To reduce heating, a pattern of the same width but larger axial length can be formed, so these pieces can still be removed by suction through a needle. For example, if the lens is cut into pieces of 1×1×4 mm in size, a total of N=6996 pulses will be required per 4 cubic mm of tissue. The temperature elevation will be DT=(E 1 *N)/pcV=69.96 mJ/(4.19 mJ/K)/4=1.04 K. Such temperature elevation can be well tolerated by the cells and tissues. [0098] An alternative solution to thermal limitations can be the reduction of the total energy required for segmentation by tighter focusing of the laser beam. In this regime a higher repetition rate and low pulse energy may be used. For example, a focal distance of F=50 mm and a beam diameter of D b =10 mm would allow for focusing into a spot of about 4 μm in diameter. In this specific example, repetition rate of about 32 kHz provides an 8 mm diameter circle in about 0.2 s. [0099] To avoid retinal damage due to explosive vaporization of melanosomes following absorption of the short laser pulse the laser radiant exposure on the RPE should not exceed 100 mJ/cm 2 . Thus NA of the focusing optics should be adjusted such that laser radiant exposure on the retina will not exceed this safety limit. With a pulse energy of 10 μJ, the spot size on retina should be larger than 0.1 mm in diameter, and with a 1 mJ pulse it should not be smaller than 1 mm. Assuming a distance of 20 mm between lens and retina, these values correspond to minimum numerical apertures of 0.0025 and 0.025, respectively. [0100] To avoid thermal damage to the retina due to heat accumulation during the lens fragmentation the laser irradiance on the retina should not exceed the thermal safety limit for near-IR radiation—on the order of 0.6 W/cm 2 . With a retinal zone of about 10 mm in diameter (8 mm pattern size on a lens+1 mm on the edges due to divergence) it corresponds to total power of 0.5 W on the retina. [0101] Transverse Focal Volume [0102] It is also possible to create a transverse focal volume 50 instead of an axial focal volume described above. An anamorphic optical scheme may used to produce a focal zone 39 that is a “line” rather than a single point, as is typical with spherically symmetric elements (see FIG. 16 ). As is standard in the field of optical design, the term “anamorphic” is meant herein to describe any system which has different equivalent focal lengths in each meridian. It should be noted that any focal point has a discrete depth of field. However, for tightly focused beams, such as those required to achieve the electric field strength sufficient to disrupt biological material with ultrashort pulses (defined as t pulse <10 ps), the depth of focus is proportionally short. [0103] Such a 1-dimensional focus may be created using cylindrical lenses, and/or mirrors. An adaptive optic may also be used, such as a MEMS mirror or a phased array. When using a phased array, however, careful attention should be paid to the chromatic effects of such a diffractive device. FIGS. 17A-17C illustrate an anamorphic telescope configuration, where cylindrical optics 40 a/b and spherical lens 42 are used to construct an inverted Keplerian telescope along a single meridian (see FIG. 17A ) thus providing an elongated focal volume transverse to the optical axis (see FIG. 17C ). Compound lenses may be used to allow the beam's final dimensions to be adjustable. [0104] FIG. 18 shows the use of a pair of prisms 46 a/b to extend the beam along a single meridian, shown as CA. In this example, CA is reduced rather than enlarged to create a linear focal volume. [0105] The focus may also be scanned to ultimately produce patterns. To effect axial changes, the final lens may be made to move along the system's z-axis to translate the focus into the tissue. Likewise, the final lens may be compound, and made to be adjustable. The 1-dimensional focus may also be rotated, thus allowing it to be aligned to produce a variety of patterns, such as those shown in FIGS. 9 and 10 . Rotation may be achieved by rotating the cylindrical element itself. Of course, more than a single element may be used. The focus may also be rotated by using an additional element, such as a Dove prism (not shown). If an adaptive optic is used, rotation may be achieved by rewriting the device, thus streamlining the system design by eliminating a moving part. [0106] The use of a transverse line focus allows one to dissect a cataractous lens by ablating from the posterior to the anterior portion of the lens, thus planing it. Furthermore, the linear focus may also be used to quickly open the lens capsule, readying it for extraction. It may also be used for any other ocular incision, such as the conjunctiva, etc. (see FIG. 19 ). [0107] Cataract Removal Using a Track and Treat Approach [0108] A “track and treat” approach is one that integrates the imaging and treatment aspect of optical eye surgery, for providing an automated approach to removal of debris such as cataractous and cellular material prior to the insertion of an IOL. An ultrafast laser is used to fragment the lens into pieces small enough to be removed using an irrigating/aspirating probe of minimal size without necessarily rupturing the lens capsule. An approach such as this that uses tiny, self-sealing incisions may be used to provide a capsule for filling with a gel or elastomeric IOL. Unlike traditional hard IOLS that require large incisions, a gel or liquid may be used to fill the entire capsule, thus making better use of the body's own accommodative processes. As such, this approach not only addresses cataract, but presbyopia as well. [0109] Alternately, the lens capsule can remain intact, where bilateral incisions are made for aspirating tips, irrigating tips, and ultrasound tips for removing the bulk of the lens. Thereafter, the complete contents of the bag/capsule can be successfully rinsed/washed, which will expel the debris that can lead to secondary cataracts. Then, with the lens capsule intact, a minimal incision is made for either a foldable IOL or optically transparent gel injected through incision to fill the bag/capsule. The gel would act like the natural lens with a larger accommodating range. [0110] It is to be understood that the present invention is not limited to the embodiment(s) described above and illustrated herein, but encompasses any and all variations falling within the scope of the appended claims. For example, materials, processes and numerical examples described above are exemplary only, and should not be deemed to limit the claims. Multi-segmented lens 30 can be used to focus the beam simultaneously at multiple points not axially overlapping (i.e. focusing the beam at multiple foci located at different lateral locations on the target tissue). Further, as is apparent from the claims and specification, not all method steps need be performed in the exact order illustrated or claimed, but rather in any order that accomplishes the goals of the surgical procedure. DETAILED DESCRIPTION OF THE INVENTION [0111] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

A system for ophthalmic surgery on an eye includes: a pulsed laser which produces a treatment beam; an OCT imaging assembly capable of creating a continuous depth profile of the eye; an optical scanning system configured to position a focal zone of the treatment beam to a targeted location in three dimensions in one or more floaters in the posterior pole. The system also includes one or more controllers programmed to automatically scan tissues of the patient's eye with the imaging assembly; identify one or more boundaries of the one or more floaters based at least in part on the image data; iii. identify one or more treatment regions based upon the boundaries; and operate the optical scanning system with the pulsed laser to produce a treatment beam directed in a pattern based on the one or more treatment regions.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of U.S. patent application Ser. No. 14/478,854 filed Sep. 5, 2014, which claims the benefit of U.S. Provisional Application No. 61/874,273 filed Sep. 5, 2013, both of which are hereby incorporated by reference as though fully set forth herein. BACKGROUND OF THE INVENTION a. Field of the Invention [0002] The instant invention relates to smoking articles. More specifically, the instant invention relates to cigarettes. b. Background Art [0003] In 2005, the European Commission established maximal values for “tar” (10 mg), nicotine (1 mg), and carbon monoxide (CO; 10 mg) per cigarette or “10-1-10,” as measured by the International Organization for Standardization (ISO) method, from 1 Jan. 2004. This is part of a trend of lower product yield for all smoke compounds delivered in the cigarette that entails developing new cigarette designs of lower yields while maintaining product taste and acceptability. [0004] It is well known that smoking articles, particularly conventional filtered or unfiltered cigarettes, provide an increasing per puff yield of particulate matter (“puff-to-puff yield”) as the cigarette is smoked. In the past, high-efficiency filters and air dilution have been used to provide a lower total yield of particulate matter in the so-called “low tar” and “ultra-low tar” cigarettes now available in the marketplace. However, manufacturers find that high-efficiency filters significantly increase the pressure drop of the cigarette and decrease yield, especially in the first few puffs of the cigarette. [0005] Likewise, air dilution helps to reduce the pressure drop somewhat, but also further reduces the per puff yield in the first few puffs. In combination, high-filtration efficiency and air dilution configured in the conventional way in a cigarette not only produces the desired lower total yield, but also produces an undesirable per puff yield or puff profile of little yield in the first few puffs and a high yield in the final few puffs. The puff profile of this type of configurations is perceived by the smoker of a cigarette as of inconsistent taste characteristics, i.e., little or no taste in the first few puffs and a harsh and overbearing taste in the final few puffs. [0006] The art has attempted to address this problem in several ways as discussed below. The proposed solutions, however, lack the ease of manufacturing required to scale up commercialization of tar-controlled delivery products. [0007] For example, U.S. Pat. No. 8,240,315 B2 teaches about a smoking article that provides lower amounts of total particulate matter in a latter portion of its puff count. The smoking article includes a cylinder of smoking material, a combustible hollow tube within the cylinder of smoking material, and a heat sink at a downstream end of the hollow tube. The smoking article also includes a filter system attached to the cylinder of smoking material having a sorbent material and at least one downstream segment of filtering material. [0008] U.S. Pat. No. 8,235,057 B2 teaches about a smoking article which includes a tobacco rod adapted to produce mainstream smoke, and a filter having an upstream end and a downstream end, wherein the filter is arranged to receive mainstream smoke at the upstream end. The filter includes a tubular segment open at the downstream end thereof and a flow restrictor contained within the tubular segment. The filter is attached to the tobacco rod with tipping paper and includes an air-admissible ventilating zone at a location between the upstream end and the downstream end of the filter. [0009] United States patent application publication no. 2008/0216851 A1 proposes to include a smokable filler of a smoking article with a high aerosol former content and a filter. Preferably, the smokable filler includes about 4 wt. % glycerin to about 35 wt. % glycerin. The filter includes a cylindrical tube attached to the tobacco rod with tipping paper, a first filter segment at a location along said cylindrical tube adjacent and in a downstream relation to said tobacco rod, and a flow restricting filter segment at a location adjacent and in a downstream relation to the first filter segment. In an embodiment, the filter also includes a cavity adjacent and in a downstream relation to the flow restricting filter segment, and a ventilation zone at a location along the cavity including perforations that extend through the tipping paper and the cylindrical tube. Preferably, the ventilation zone is in a downstream relation to the flow restricting filter segment. [0010] United States patent application publication no. 2007/0186945 A1 teaches about a smoking article, which provides lower amounts of total particulate matter in a latter portion of its puff count, which includes a cylinder of smoking material, a combustible hollow tube within the cylinder of smoking material, and a heat sink at a downstream end of the hollow tube. The smoking article also includes a filter system attached to the cylinder of smoking material having a sorbent material and at least one downstream segment of filtering material. [0011] U.S. Pat. No. 5,435,326 proposes a smoking article which has a controlled yield of wet particulate matter and a method of making a smoking article with predetermined total and per puff yields of wet particulate matter. The smoking article has a tobacco rod connected to an air ventilated compound filter having two abutted filter segments, a rod end segment with a passage therethrough and a mouth end segment. The pressure drop of the abutment interface between the segments is selected to be in a range of from about 10 mm to about 100 mm water gauge. According to this patent, the total pressure drop of the filter including the interface and the amount of air dilution can be selected to provide a smoking article with a level per puff yield or a decreasing per puff yield. [0012] Furthermore, U.S. Pat. No. 4,972,853 teaches about a cigarette filter rod element that includes an axially-extending barrier tube of micro-fine fibers with a diameter of between 0.5 and 10 microns and located so that at least part of the gas flow passes through the wall of said barrier tube. U.S. Pat. No. 4,942,887 teaches about tobacco containing cigarette filter plugs that comprise strands of tobacco material which are bound with an activated binding agent. According to the '887 patent, the filter-plugs exhibit good firmness and integrity, and provide cigarettes exhibiting a unique tobacco taste. Filter plugs are prepared by forming an intimate admixture of tobacco material and binding agent, forming rods, and activating the binding agent. U.S. Pat. No. 4,109,666 teaches about a filter tipped cigarette that also includes a cylindrical tobacco section and a cylindrical filter axially aligned therewith. The filter is comprised of an axially aligned tube extending from said tobacco section, a layer of filter material positioned circumferentially about said tube, and a diffuser adjacent an end of the tube for dispersing the smoke received from the tube prior to entering the smoker's mouth. [0013] One of the major drawbacks from what is described in the '326 patent noted above is a limitation in filter construction which is relegated to 31 mm filter designs based on the components identified to achieve relative consistency from puff to puff. Specifically, the prior art teaches that at least a 17 mm cellulose acetate (CA) filter segment equipped with a 1.0-1.5 mm tube is necessary to combine with a traditional cellulose filter segment to achieve a desired effect. In addition, the prior art teaches that interfacial abutment pressure between the “functional” filter segment and the standard cellulose acetate must be greater than traditional pressures achievable on standard filter rod making equipment; and, therefore, the ability to manufacture functional filters at commercially relevant speeds is unlikely. To that end, the basis of the purported invention of the '326 patent relies on the fact the CA segment containing the tube be sufficiently long so that the primary flow of mainstream smoke travels through the 1.0-1.5 mm tube and not through the surrounding CA material. This is due to the pressure drop differences between the tube and the CA material, requiring long filter segments to achieve the effect. When the pressure drop difference between the capillary tube and the surrounding material are similar, the effect cannot be achieved. Therefore, shorter filter constructions such as 27 mm, 25 mm, and 21 mm filters are not possible using what is described in U.S. Pat. No. 5,435,326. [0014] The foregoing discussion is intended only to illustrate the present field and should not be taken as a disavowal of claim scope. BRIEF SUMMARY OF THE INVENTION [0015] It is desirable to be able to provide methods to design and fabricate filter elements, compound filter constructions, and cigarette designs to manufacture smoking articles of tar yield delivery such that the tar yields of the first few puffs are perceived by the smoker similarly to the last few puffs during smoking. Furthermore, it would be desirable to provide such cigarettes with filter elements that can be easily manufactured using conventional manufacturing equipment and methods that allow broader filter design flexibility and potential application to 10:1:10 products wherein it may be possible to achieve a higher tar, full flavor taste experience in a reduced tar cigarette. [0016] In various embodiments, a description of the methods of fabrication of filter elements for the infinite-pressure-drop and very-high-pressure-drop filter rods is provided. [0017] In at least one embodiment, a method of making infinite-pressure-drop filter rods for a smoking article, particularly a cigarette, comprises extruding a plastic resin into a tube by using a die design with a pin of a desirable diameter to form a hollow string, drawing the hollowed string, cooling the drawn hollowed string in a cooling trough, and cutting the drawn and cooled hollowed string into filter rods. [0018] In addition to the various methods described herein, the invention also comprises the resulting filter elements, filters, and cigarettes. [0019] The foregoing and other aspects, features, details, utilities, and advantages of the present invention will be apparent from reading the following description and claims, and from reviewing the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 is cross-sectional view of a cigarette according to one embodiment of the invention. [0021] FIG. 2 is a table of design parameters and performance of various embodiments compared to traditional filter controls. [0022] FIG. 3 depicts tar delivery for a 100 mm cigarette constructed according to an embodiment of this invention using an infinite pressure drop material with a 2.0 mm inner diameter (ID) filter segment cavity compared to a traditional cellulose acetate filtered cigarette. [0023] FIG. 4 depicts tar delivery for an 80 mm cigarette constructed according to an embodiment of this invention using an infinite pressure drop material with a 2.0 mm ID filter segment cavity compared to a traditional cellulose acetate filtered cigarette. [0024] FIG. 5 shows tar consistency of cigarette prototypes built according to embodiments of this invention with different inner diameters. [0025] FIG. 6 shows tar consistency of cigarettes built according to embodiments of this invention. [0026] FIG. 7 shows the effect of air ventilation technology on tar consistency for infinite-pressure-drop element cigarette prototypes built according to embodiments of this invention. [0027] FIG. 8 shows the effect of the tow density of the mouth piece on tar consistency for infinite pressure drop element prototypes built according to embodiments of this invention into 100 mg cigarette prototypes. [0028] FIG. 9 shows a schematic for the fabrication of infinite pressure drop filter rods using a conventional twin extruder. [0029] FIG. 10 shows a schematic representation of the incorporation of tubing onto a moving tow band used for filter rod making. [0030] FIG. 11 shows the filter rods attributes for the filter rod element of embodiments of this invention. [0031] FIG. 12 is a sketch of a typical filter rod and its dimensions. [0032] FIG. 13 depicts tar delivery for a cigarette constructed according to an embodiment of this invention using a tube-in-tow design with a 2.0 mm inner diameter (ID) filter segment cavity compared to a traditional cellulose acetate filtered cigarette. [0033] FIG. 14 shows the pressure differential between puffs versus the slope of the puffs for air ventilated cigarettes having hollow channels of increasing inner diameters. DETAILED DESCRIPTION OF THE INVENTION [0034] The embodiments of the invention described herein discloses a filter construction and design using a non-CA based material of infinite pressure drop (e.g. an impermeable material) as a filter segment contained in 27 mm and 21 mm filter designs wherein the puff-to-puff variation is essentially zero over the course of smoking. Specifically, the invention uses a 5-12 mm long foamed polyethylene (PE) or polypropylene (optionally CA) filter segment that has an infinite pressure drop containing a 1.5-2.0 mm diameter axial cavity that allows mainstream smoke to pass through unobstructed, wherein the mainstream smoke is filtered in a traditional CA filter segment located at the mouth-end of a cigarette further equipped with air dilution holes. An additional benefit of the foamed PE filter segment is a single piece in contrast to a CA filter segment containing a tube, and the foamed PE filter segment can be extruded using high-volume production equipment commonly found in the plastics industry. [0035] It would be desirable, therefore, to provide methods to fabricate and design filter elements, compound filter constructions, and cigarettes designs to manufacture smoking articles of tar yield delivery such that the tar yield of the first few puffs are perceived by the smoker similarly to the last few puffs during smoking. Furthermore, it would be desirable to provide such cigarettes with filter elements that can be easily manufactured using conventional manufacturing equipment and methods that allow broader filter design flexibility and potential application to 10:1:10 products wherein it may be possible to achieve a higher tar, full flavor taste experience in a reduced tar cigarette. [0036] FIG. 1 generally illustrates an air ventilated cigarette 10 formed with a regular tobacco column 12 , a pressure drop element (i.e., axial cavity filter element) 14 including hollow channel 16 and a solid, high-density mouth piece (e.g. a high permeability, low pressure drop material) 18 . The air ventilation holes 20 can be placed in any location along the filter zone to control the organoleptic profile of the smoking article as well as the filter performance. Additionally, the filters can be built with a one or more microcapillary or tubular, axially-located cavity structures. Tipping wrapper 22 is used to hold the pressure drop element 14 and the high-density mouth piece 16 in engagement along an abutment interface 24 . [0037] FIG. 2 shows non-limiting examples of filter design constructions that embody this invention. More specifically, FIG. 2 provides examples of design parameters and performance of the filter design according to this invention as compared with traditional filters. The examples shown in FIG. 2 were built either using polyethylene hollow rods (e.g. an impermeable, infinite pressure drop material) or polypropylene inserted into a commercial cellulose acetate filter tow rod segment treated with a density enhancer (e.g. a low permeability, very high pressure drop material). [0038] In the art, the term “tar” means total particulate matter of the mainstream smoke after subtracting water and nicotine. It is measured according to a standard procedure under standard machine smoking conditions. Another nomenclature that is used to describe cigarette strength is total particulate matter (TPM). This is usually measured by collecting the particulate in filter pads while machine smoking the cigarette, and will be preferably used herein. [0039] TPM or tar delivery consistency is measured as the regressed slope for delivered tar between puff 2 and puff 8. A regressed slope of zero signifies constant tar delivery during smoking. As the slope progresses toward “zero,” the tar delivery constancy increases. The examples of the invention presented herein show that this invention reduces that slope toward zero value and increases its efficiency for delivery tar consistency. For instance, FIGS. 3 and 4 show the TPM delivery during smoking for axial filter designs of this invention using infinite pressure drop materials, such as polymers, for 100 and 80 mm cigarette constructions, respectively. In both cases, the TPM profile of cigarette prototypes embodying this invention are ‘flatter,’ indicating a more consistent delivery of TPM from the first few puff to the last few puffs. [0040] Additional embodiments of this invention comprise empirical relationships between % air dilution and its location, tow density and hollow inner diameter insert and its length, mouth piece density, that affect the consistency of the delivered yields as measured by the slope between the initial few puffs and the latest few puffs. These relationships are useful to design air diluted cigarettes with more consistent tar delivery at equivalent “tar” level of commercially available ones. It is expected that the organoleptics properties of these cigarettes will preferentially benefit a more balanced smoking experience. [0041] FIG. 5 shows that tar consistency depends on the inner diameter of the hollow tube or microcapillary used in the axial cavity filter element. More specifically, FIG. 5 shows an improvement on tar consistency at small IDs. The data shows a reduction of the tar slope with a minimum slope at about 2.0 mm of ID for these particular prototype designs. Smoking article manufacturers can, therefore, design cigarettes with higher consistency by judiciously using the inner diameter as a controlling variable. [0042] FIG. 6 shows that tar consistency depends on the length of the filter element at a given % of air dilution and inner diameter of the hollow tube or microcapillary used in the filter element. More specifically, FIG. 6 shows an improvement on tar consistency as very-high-pressure filter segment increases in length (open circles) as well as tar consistency for infinite pressure drop segment-built (closed circles) cigarettes. The data shows a reduction of the tar slope for cellulose acetate-constructed prototype designs while the infinite pressure drop cigarette designs have near maximum tar consistency, which it not affected by the length of the segment. Thus, in accordance with this invention, the pressure drop further increases as the filter element becomes longer with a limit given as the infinite pressure drop element. Smoking article manufacturers can therefore design cigarettes with higher consistency by judiciously using the filter element length in conjunction with appropriate air dilution and mouth piece of this invention as a controlling variable. [0043] FIG. 7 shows that tar consistency depends on both the position of the air ventilation holes as well as the amount of air ventilation (%) in the practice of embodiments of this invention. More specifically, FIG. 7 shows tar consistency improvement as the distance between the ventilation holes to the mouth piece end at various level of air ventilation in infinite-pressure-drop element filter designs decreases. The data shows a reduction of the tar slope for these particular prototype designs as well as demonstrating that there is an interaction between the amount of air ventilation and where it happens. It is possible to explain this behavior by considering that air ventilation affect changes on filtration efficiency of the filters and, therefore, also the pressure drop would increase further as the localized cooler air interacts with the smoke stream. Smoking article manufacturers can therefore design cigarettes with higher tar consistency by judiciously using air ventilation technology as a controlling variable. [0044] FIG. 8 shows that tar consistency also depends on the tow density of the mouth piece used in the filter design. More specifically, FIG. 8 shows tar consistency improvement as cigarette prototypes are built with higher tow density in the mouth piece in infinite-pressure-drop element filter designs. The data shows a reduction of the tar slope for these particular prototype designs. Thus, in accordance with this invention, a higher tow type would increase faster in filtration efficiency of the filters during smoking, and therefore also the pressure drop would increase further as the localized cooler air interact with the smoke stream. It would foul the zone area where the mouth piece and the smoke stream interact strongly, “focusing effect.” Smoking article manufacturers can therefore design cigarettes with higher tar consistency by judiciously using high-density tow in the mouth piece as a controlling variable. [0045] Methods of Construction of Filter Elements [0046] Following are descriptions of possible methods of fabricating the infinite-pressure-drop filter element and very-high-pressure filter rods. [0047] A. Infinite-Pressure-Drop Filter Element [0048] A method to fabricate a filter rod for a smoking article according to an embodiment of this invention comprises extruding a plastic resin from hopper 26 into a tube by using a die design with a pin of a desired diameter held within a die holder to form a hollow string. The hollowed string is then drawn and cooled in a cooling trough 28 and, finally, cut into filter rods 30 using a take-up and cut-off assembly 32 . FIG. 9 schematically depicts this method of fabricating a filter rod using a conventional twin extruder 34 . [0049] The practice of embodiments of this invention is not limited to polyolefin resins, but it is inclusive of other melt extrudable polymeric resins appropriate to manufacture microcapillary and hollow tubes such as, for example, foamed polyethylene, polypropylene, nylon, polycarbonate, and cellulose acetate. [0050] B. Very-High-or-Infinite-Pressure-Drop Filter Elements [0051] A method to fabricate the rod according to embodiments of this invention comprises incorporating plastic microcapillary 36 or tubes into cellulose acetate filter rods to form hollow rods, e.g. a tube-in-tow design. This has been accomplished by inserting the microcapillary 36 onto the path of a moving tow band 38 passing over delivery roll 40 A and transport roll 40 B. FIG. 10 schematically depicts the method employed during filter making using a conventional filter maker. It operates by passing cellulose filament bundles through a plug maker garniture to spread the tow filaments and then wrapping together with paper the tow and the microcapillary 36 . The microcapillary 36 is added from a spool into the garniture after the addition of the plasticizer and final conversion into filter rods. However, addition of the tubes can also be added prior to plasticizer addition. [0052] According to embodiments of another aspect of this invention, a tow density enhancer 42 or plasticizers is sprayed by sprayer 44 into the moving tow band 38 to increase the tow density and manufacture the desired tow density. The density enhancer consists of triacetin, polyvinyl acetate, poly acrylic acid, acrylates, and polyvinyl alcohol. In other embodiments the density enhancer consists of solid mineral powder such as calcium carbonate and polymeric powder such as polyethylene, polypropylene, and cellulose acetate. A very high tow density is needed to form very-high-pressure-drop filter segments (e.g. a low permeability material). Furthermore, the practice of embodiments of this invention is not limited to polycarbonate materials, but it is inclusive of other polymeric resins appropriate to manufacture the rods of this invention such as, for example, polyethylene, polypropylene, nylon, and cellulose acetate. [0053] Using either of the methods described above, it is possible to fabricate filter rods elements suitable to practice embodiments of this invention that have attributes shown in FIG. 11 . FIG. 11 shows the working ranges, preferred, and most preferred filter rod characteristics. FIG. 12 schematically depicts an example of the dimension of typical rods 46 manufactured using the methods of this invention. [0054] Smoking Procedure [0055] The tested cigarettes were tested by smoking them using the following procedure: 2 second smoking puff duration, 58 second wait between puffs, and 35 ml puff volume in a smoking machine. The particulate was collected on a Cambridge filter pad. Each Cambridge filter pad was weighed in its holder before and after smoking to calculate TPM or “tar.” A Borgwaldt RM 20/CS smoking machine with a twin-filter attachment was used for smoking the cigarettes. The cigarettes were smoked to a butt length 3 mm from the tipping paper. [0056] FIG. 13 depicts tar delivery for a cigarette constructed according to an embodiment of this invention using a tube-in-tow design with a 2.0 mm inner diameter (ID) filter segment cavity compared to a traditional cellulose acetate filtered cigarette. As discussed, TPM or tar delivery consistency is measured as the regressed slope for delivered tar between puff 2 and puff 8 . A regressed slope of zero signifies constant tar delivery during smoking. As the slope progresses toward “zero,” the tar delivery constancy increases. The examples of the invention presented herein show that this invention reduces that slope toward zero value and increases its efficiency for delivery tar consistency. For instance, FIG. 13 shows the TPM delivery during smoking for axial filter designs of this invention using a tube-in-tow design, such as a polymeric tube inserted into a hollow CA body treated with a density enhancer, for 100 and 80 mm cigarette constructions, respectively. In both cases, the TPM profile of cigarette prototypes embodying this invention are ‘flatter,’ indicating a more consistent delivery of TPM from the first few puff to the last few puffs. [0057] FIG. 14 shows the pressure differential of the filter between the first and last puffs versus the slope of the puffs for air ventilated cigarettes having hollow channels of differing inner diameters. As shown at call out A, having a hollow channel inner diameter of 1.7 mm or less results in mostly negative slope of puffs corresponding with high levels of puff differentials between the beginning and final puffs. Such values are indicative of a small tube channel that results in fouling of the mouth end filter element, thereby resulting in large pressure differentials as the mouth end filter element becomes fouled with each additional puff. Thus, a negative slope of puff results as the TPM decreases from puff number 1 to puff number 8 , as shown, for example, in box D. Such characteristics result in undesirable, inconsistent smoking experiences. [0058] As shown at call out B, having a hollow channel inner diameter of 1.7 mm to 2.2 mm results in a slightly positive slope of puff corresponding with acceptable levels of puff differentials between the beginning and final puffs. Such values are indicative of a tube channel that results in less fouling of the mouth end filter element as compared to smaller diameters, thereby resulting in acceptable pressure differentials as the mouth end filter element becomes fouled with each additional puff. Thus, a slightly positive slope of puff results as the TPM decreases from puff number 1 to puff number 8 , as shown, for example, in box E. Such characteristics, typical of cigarette filters of the present invention (e.g. infinite pressure drop hollow tubes and tube-in-tow designs) result in desirable, consistent smoking experiences. [0059] As shown at call out C, having a hollow channel inner diameter of 2.2 mm or greater results in mostly positive slope of puff corresponding with low levels of puff differentials between the beginning and final puffs. Such values are indicative of a large tube channel that result in minor fouling of the mouth end filter element, thereby resulting in only small pressure differentials as the mouth end filter element becomes fouled with each additional puff. Thus, a largely positive slope of puff results as the TPM decreases from puff number 1 to puff number 8 , as shown, for example, in box F indicating an undesirable puff profile. Such characteristics, typical of conventional cigarette filters, result in undesirable, highly inconsistent smoking experiences, contrary to the desired experiences indicated by call out B and box E. [0060] FIG. 14 , in view of the forgoing, demonstrates that rod end filter segments having interior passages can result in both small puff differentials and low slope of puffs when combined with very high or infinitely high pressure differential materials of the rod end filter segment. Furthermore, the diameter of the passage can be increased beyond previously used methods of the prior art. For example, the diameter of the interior passage can be increased without regard to an abutment pressure between the rod end filter segment and a solid mouth end filter segment if the material of the rod end filter segment has a very high or infinitely high pressure drop (e.g. has low permeability or is impermeable). [0061] Smoking articles produced according to the methods and designs disclosed herein have tar yield deliveries such that the tar yield of the first few puffs are perceived by the smoker similarly to the last few puffs during smoking. Furthermore, the single piece, infinite pressure drop rod end segments and tube-in-tow designs are easy to manufacture, thereby facilitating increased production rates. For example, the single piece, infinite pressure drop segments can be extruded using conventional systems. Additionally, in any of the designs disclosed herein, the abutment pressure between the mouth end filter segment and the rod end filter segment is low enough to not require sophisticated, costly and slow assembly techniques. [0062] Embodiments are described herein of various apparatuses, systems, and/or methods. Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and illustrated in the accompanying drawings. It will be understood by those skilled in the art, however, that the embodiments may be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those of ordinary skill in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and thus it can be appreciated that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of all embodiments. [0063] Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment,” or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment(s) is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment,” or the like, in places throughout the specification, are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features, structures, or characteristics of one or more other embodiments without limitation given that such combination is not illogical or non-functional. [0064] It will be appreciated that joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements. As such, joinder references do not necessarily infer that two elements are directly connected to each other. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims.

A filter for a smoking article comprises a mouth end filter segment and a rod end filter segment. The rod end filter segment has a passage extending longitudinally therethrough. The passage has a diameter of about 1.0 mm or greater. In one embodiment, the rod end filter segment is comprised of an infinite pressure drop material. In another embodiment, the rod end filter segment is comprised of a low pressure drop material having a hollow tubular element disposed within to define the passage with an inner diameter greater than about 1.55 mm. Air dilution means are disposed in one of said filter segments to admit ventilating air into the filter.

CROSS REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional application Ser. No. 60/011,681, filed Feb. 15, 1996. FIELD OF THE INVENTION The present invention relates generally to forage harvesters and more particularly to a new knife design and associated knife mounting apparatus for a harvester cutterhead unit having a segmented knife configuration. BACKGROUND OF THE INVENTION A typical forage harvester operates in a field to process windrowed or standing forage crop and includes a mobile base unit that is either self propelled or pulled by a tractor. A header, attached to the base unit, either cuts standing crop material such as corn or picks up windrowed crop material such as hay and feeds such crop material rearwardly. The base unit includes a forwardly located generally rectangular inlet opening adjacent the header for receiving crop material from the attachment. A feeding assembly spans the width of the inlet opening for conveying material fed into the base unit to a cutting assembly that chops it into pieces appropriately sized for feeding to livestock. Also included on the base unit are means for transferring the chopped crop material to a vehicle that transports it from the field to a remote location where it is delivered to a storage facility, such as a silo. Prior art cutting assemblies typically consist of a rotating cutterhead on which knives are mounted for travel through a cylindrical path, and a fixed knife mounted adjacent the path of the moving knives. The feeding assembly usually comprises one or more pairs of opposing counter-rotating rolls for feeding a mat of crop material across a flat face surface of the fixed knife, commonly referred to as a shear bar, operatively associated with cutting edges on the moving knives. The face surface is in an imaginary radial plane extending outwardly from the axis about which the cutterhead rotates to optimize the shearing action of the knives. As crop material is fed, it is chopped into lengths determined by the relationship of the feed rate of the feed rolls to the rotational speed of the cutterhead. One known type of cutterhead consists of a plurality of spiral knives mounted on a series of side by side axially spaced disc shaped members. Exemplary structure of this nature is shown in U.S. Pat. No. 4,209,137, issued Jun. 24, 1980 in the name of Ronald L. McAllister, et al. FIGS. 1 and 2 of this patent are identified as prior art and presented in this application as FIGS. 3 and 4. Other examples of prior art forage harvesters having spiral knives mounted via a plurality of spaced disc shaped plates are disclosed in U.S. Pat. Nos. 3,958,766, issued May 25, 1976 in the name of Joe E. Shriver, and No. 3,873,038, issued Mar. 25, 1975 in the name of Robert A. Wagstaff. Another well known cutterhead design employs a segmented knife configuration mounted on a hollow cylindrical drum, an example of which is disclosed in U.S. Pat. No. 4,061,284, issued Dec. 6, 1977 in the name of Wesley Paul Raisbeck, et al. Another example of prior art showing a similar configuration is U.S. Pat. No. 4,189,875, issued Feb. 26, 1980 in the name of John H. Flenniken, in which a perspective view of a segmented knife arrangement mounted on a hollow cylindrical drum is shown at FIG. 2. It should be noted that insofar as segmented are concerned, the simple flat segmented knife design contemplated in the cutterhead shown in U.S. Pat. No. 4,061,284, mentioned above, is not uncommon. However, various other knife designs are also known. For example, U.S. Pat. No. 4,257,566, issued Mar. 24, 1981 in the name of Allan K. Lawrence, Danish Patent No. 93,543, issued May 28, 1962, and Russian Patent No. 377,124 issued in 1973, disclose bent knife designs used in both segmented and spiral configurations. Another knife design, a curved shape, is shown in U.S. Pat. No. 3,357,467, issued Dec. 12, 1967 in the name of James Morkoski, and No. 3,378,053, issued Apr. 16, 1968 in the name of Wolfgang R. Potsch. In segmented knife cutterheads, as in all forage harvester cutterheads, the rake angle of the knives is an important design consideration, i.e., the acute angle of the knife relative to crop material being fed across the shear bar. It is desirable to have this angle, which is inclined with respect to the imaginary radial plane mentioned above, maximized to reduce cutting energy, and thus improve efficiency. When flat knives are employed, the incline with respect to the tip path is dictated by the distance of radial protrusion of the knife clamping means, as illustrated by the clamping bolts in the cutterhead shown in U.S. Pat. No. 4,061,284. The clamping means must not protrude beyond the cylinder generated by the path of the knife tips, as is also apparent from the spiral design shown in U.S. Pat. No. 3,873,038. U.S. Pat. No. 4,257,566, mentioned above as one example of bent knives, is illustrative of an attempt in the prior art to provide an effective rake angle in a segmented cutterhead in which the knife assemblies are mounted on a drum. Each knife is bent such that the cutting edge is directed radially inward relative to the cylinder generated by such cutting edge. This improves efficiency and provides clearance for the clamping means, which in this case is a series of cap screws along a plate. A similar prior art bent knife design is shown in detail in FIGS. 8 and 9 of the following specification, wherein a portion of the flat bar from which the bent knife is formed is milled away to reduce the thickness prior to bending. SUMMARY OF THE INVENTION An important object of the present invention is to provide an improved segmented knife design for a forage harvester cutterhead that lends itself to simple manufacturing techniques without reducing the efficiency of the cutterhead. Another important object is to provide a durable segmented forage harvester knife assembly for mounting on a rotatable cutterhead drum. Still another important object is to provide alternate segmented knife designs for forage harvester cutterheads that provide rake angles that enhance efficiencies. In pursuance of these and other important objects the present invention in one instance contemplates a rotatable forage harvester cutterhead comprising a shaft, a drum assembly having an outer cylindrical surface, means for coaxially securing the drum assembly to the shaft, and a plurality of knives, each of which has a cutting edge length less than half the axial length of the drum assembly. More particularly, the invention in this instance contemplates, a plurality of knife support assemblies each of which comprises a solid mounting block detachably secured to the outer cylindrical surface of the drum assembly, the mounting block having a flat mounting surface extending at an acute angle to a radial plane extending from the shaft. The support assemblies further comprise fastener means for securing a knife to the flat mounting surface of the mounting block with the cutting edge extending in the direction of rotation of the cutterhead and generating a cylinder as the cutterhead rotates, the cylinder having a diameter larger than the diameter of the drum, and the knife having a top surface and a bottom surface whereby the rake angle formed by the bottom surface of the knife and the radial plane is greater than the acute angle. The foregoing instance, as well as other instances contemplated, and other objects, features and advantages of the invention will appear more fully hereinafter from a consideration of the detailed description which follows, in conjunction with the accompanying sheets of drawings wherein principal and alternative embodiments of the invention are illustrated by way of example. It is to be expressly understood, however, that the drawings are for illustrative purposes and are not to be construed as defining the limits of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an end elevational view of a forage harvester cutterhead having segmented knives mounted on a drum. FIG. 2 is a diagrammatical top view of the forage harvester cutterhead shown in FIG. 1, and shows several parts in an exploded fashion. FIG. 3 is a perspective view of a prior art forage harvester cutterhead. FIG. 4 is an end elevational view of the prior art forage harvester cutterhead shown in FIG. 3. FIG. 5 is a view taken in the direction of arrows 5--5 in FIG. 2 showing a fragmentary enlargement of a portion of the cutterhead of FIG. 2. FIG. 6 is a plan view of a clamping plate, one each of which is used with each knife. FIG. 7 is an end elevational view of the clamping plate shown in FIG. 6. FIG. 8 is a plan view of a prior art knife design. FIG. 9 is an end elevational view of the prior art knife shown in FIG. 8. FIG. 10 is a plan view of a knife support block, one each of which is used in conjunction with a clamping plate to hold each knife in place. FIG. 11 is an end elevational view of the knife support block shown in FIG. 10. FIG. 12 is a view similar to FIG. 5 showing a fragmentary enlargement of a portion of the cutterhead shown in FIGS. 1 and 2 in which the unique knife design of the present invention is incorporated. FIG. 13 is a plan view of the knife design shown in FIG. 12. FIG. 14 is an end elevational view of the knife shown in FIG. 13. FIG. 15 is a view similar to FIG. 5 showing a fragmentary enlargement of a portion of the cutterhead shown in FIGS. 1 and 2 in which an alternative embodiment of the unique knife design of the present invention is incorporated. FIG. 16 is a plan view of the knife design shown in FIG. 15. FIG. 17 is an end elevational view of the knife shown in FIG. 16. FIG. 18 is a plan view of a modified knife support block, one each of which is used with a modified clamping plate to hold the alternative knives in place, as shown in FIG. 15. FIG. 19 is an end elevational view of the knife support block shown in FIG. 18. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings for a more detailed description of the present invention, FIG. 1 shows the end view of a forage harvester cutterhead, generally designated by reference numeral 10, in which the present invention is embodied. In FIG. 2 a front view of cutterhead 10 is shown in which key parts are depicted in exploded fashion to illustrate the unique manner in which a prior art spiral knife cutterhead is converted to a segmented knife cutterhead. To this end, FIGS. 3 and 4 show a typical prior art spiral knife cutterhead 10' of the type shown in above mentioned U.S. Pat. No. 4,209,137, hereby incorporated by reference. Cutterhead 10' comprises a plurality of disc shaped plate members 11' positioned in axially spaced relationship to each other along a central shaft 12'. Plate members 11' are mounted on shaft 12' by any suitable means such as, for example, splines and keys. Pairs of plate members 11' are equally spaced along the shaft. A plurality of spirally shaped knives 13' are secured outwardly of plate members 11' by clamping bolts 14' screwed into tapped holes in mounting blocks 15' which are affixed to members 11' via bolts 16'. Turning now to FIG. 2, six pairs of disc shaped plate members 11 are positioned in axially spaced relationship to each other along a central shaft 12. Plate members 11 are equally spaced along shaft 12 in the same manner as the plates and shaft of the prior art cutterhead depicted in FIGS. 3 and 4. A plurality of segmented knives 13 are secured outwardly of plate members 11 by clamping bolts 14 screwed into tapped holes in knife support blocks 16, one of which is shown in FIGS. 10 and 11. A knife clamping plate 17, shown separately in FIGS. 6 and 7, completes the knife support assembly. A drum 18, interposed between the knife support assemblies and disc shaped plate members 11, comprises a first drum section 18' and a second drum section 18", which when assembled form a cylindrical drum having an inner diameter substantially the same as the diameters of disc shaped plate members 11. When drum sections 18' and 18" are assembled, transverse edge surfaces 20, 21 and 22, 23, respectively, are adjacently diametrically disposed. A plurality of arcuately shaped mounting blocks 24 are bolted to the outer edges of plate members 11 with the outer curved surfaces of the blocks extending past the outer edges of plate members 11, as shown in FIG. 5. These mounting blocks are mounted between the paired plates in four instances, while in the other two sets, the second innermost from each side, the blocks are mounted outwardly of the plates with spacers 25 between the plates aligned with the blocks. As also shown in FIG. 5, the entire cutterhead arrangement is secured together by screws 26 which pass through flange portion 27 of knife support blocks 16 and drum 18, and are snugly secured in tapped holes in mounting blocks 24. Each knife support block 16 is attached to two laterally adjacent mounting blocks, and each mounting block receives screws from two circumferentially adjacent knives. In the adjacent edge area of the drum sections, a mounting block 24 spans from one section to the other and receives screws from two circumferentially adjacent knife support blocks 16. No knife support blocks are mounted across the juncture between the edges, which due to tolerances may be slightly uneven. This enables the knifes to be precisely mounted thereby enhancing the sharpening function of their cutting edges which travel in a common cylindrical path. It should also be noted with respect to drum 18 that a series of small holes 28 provide relief for knife clamping bolts 14 (see FIG. 5). Although knife 13, adjustably mounted via slots 29 in a well known manner, is shown as having a bent configuration, other designs, such as the straight knife shown in U.S. Pat. No. 4,061,284, mentioned above, can also be employed. More particularly, knife 13 is bent at bend 30 along a line generally parallel to cutting edge 31 (see FIGS. 5, 8 and 9). A bent knife design of this general type is well known in the prior art, as illustrated by U.S. Pat. No. 4,257,566, also mentioned above, hereby incorporated by reference. By further reference to the prior art disclosure of U.S. Pat. No. 4,061,284, mentioned above, it is clear that it is well known to the skilled artisan that segmented knife configurations include rows of knives arranged in a side by side fashion over the full surface of a drum with adjacent knives offset along spiral paths. The present invention accommodates segmented knives in this configuration, as shown in the drawings, but is adaptable to accommodate any other configuration that results in a cylindrical knife path. In operation, the cutterhead comprises an integral part of a forage harvester and is rotated by the power source of the harvester in direction "a" (see FIG. 1) whereupon the cutting edges of the knives generate a cylinder (designated by reference letter "c" in FIG. 5) corresponding to the path of the knives in a well known manner. This path brings the cutting edges of the knives in contact with crop material being fed across an associated fixed shear bar (not shown), disposed with its face surface in an imaginary radial plane, designated by reference letter "p" (see FIG. 5). Thus, under conditions where cutterhead 10 is rotated in direction "a" the cutting edges of the knives, regardless of design, generate cylinder "c" corresponding to the path of the tips of the knives. The cutting edge is defined by beveled edge 32 and the adjacent area 33 (see FIG. 9) of the bottom surface of knife 13. This knife path maintains a rake angle "r" as the knives are rotated into contact with crop material being fed across the above mentioned associated fixed shear bar (not shown). As shown with respect to the bent knife design shown in FIG. 5, rake angle "r" is the angle between bottom surface 33 of knife 13 and imaginary plane "p". The rake angle is greater than angle "x", the angle between imaginary plane "p" and the coplanar extension of the flat surface bottom portion 13s of knife 13, and thereby reduces the area of impact of the knife on the material being chopped. This improves the efficiency of the bent knife design relative to a flat knife, which is a well known feature of the bent knife design. Now turning to knife 34 illustrated in FIGS. 12, 13 and 14, a unique design is provided by machining a flat knife with a relief portion 35 to provide the same desired rake angle "r" without necessitating a bend of the type shown in prior art knife 17, depicted in FIGS. 5 through 9. In knife 34, the cutting edge is also defined by a beveled potion 36, which provides for similar ease in sharpening as the bent knife design, but obviates the need for a bending operation during formation. In this knife assembly, as in the case of the assembly shown in FIG. 5., clamping bolts 14 do not project beyond the cylindrical path of the knife tips, which is the same as path "c" shown in FIG. 5. FIGS. 15 through 19 show another knife 37 having a curved configuration which enables rake angle "r" to be attained without necessitating a bending step during fabrication. The body of knife 37 is curved and has a constant thickness, except for beveled edge 38. Curved knife 37 is supported via a block 40 and clamping plate 41 on drum 18 by clamping bolts 14 to provide the same rake angle "r" as provided by the arrangement shown in associated FIGS. 5 and 12. A secure mounting is achieved by providing a radius of curvature on the bottom surface 42 of curved knife 37 that is slightly less than the radius of the corresponding surface of support block 40. Likewise, the radius of curvature of the corresponding surface on clamping plate 41 is slightly less than the curvature of the top surface of the knife 37. Of the many implicit and explicit advantages of the present invention one of the most important is the provision of a unique knife assembly for a forage harvester cutterhead having a rotary drum configuration. Also important is the provision of a knife designed to enhance efficiencies of the cutterhead which thereby improves overall operation and customer satisfaction. In the two principle configurations of the knife design, the manufacturing process is simplified and thereby provides additional important advantages. While preferred structure in which the principles of various embodiments of the present invention are shown and described above, it is to be understood that the invention is not limited to such structure, but that, in fact, widely different means of varying scope and configuration may be employed in the practice of the invention.

A rotatable forage harvester cutterhead having a shaft with a drum assembly coaxially secured to the shaft. A plurality of uniquely configured knives extend from the outer cylindrical surface of the drum, each with a cutting edge length less than half the axial length of the cylindrical surface. The knives are supported by assemblies having a solid mounting block secured to the outer cylindrical surface, which mounting blocks have a mounting surface extending at an acute angle to a radial plane extending from the shaft. Fasteners secure the knives to the mounting surfaces with the cutting edges of the knives extending in the direction of rotation of the cutterhead and generating a cylinder as the cutterhead rotates. The knife designs enhance efficiencies by providing a rake angle, formed by the bottom surface of the knife and the radial plane, that is greater than the acute angle.

FIELD OF THE INVENTION [0001] Embodiments of the present invention generally relate to fishing. Particularly, embodiments of the present invention relate to ice fishing. More particularly, embodiments of the present invention relate to utilities to make ice fishing more enjoyable. BACKGROUND OF THE INVENTION [0002] Ice fishing is an activity of catching fish with lines and fish hooks or spears through an opening in the ice on a frozen body of water. Ice anglers may sit on the stool in the open on a frozen lake, or in a heated cabin on the ice, some with bunks and amenities. [0003] It is a popular pastime in Canada, Finland, Estonia, Norway, Sweden and Germany. In the United States, people from Alaska, Colorado, Montana, Minnesota, Wisconsin, Michigan, New York, the states of New England and other areas with lakes and long, cold winters enjoy the activity. [0004] Ice fishing gear is highly specialized. First, an ice saw, auger or chisel is required to cut a circular hole or larger rectangular hole in the ice. Power augers are sometimes used. A skimmer is used to remove new ice as it forms and to clear slush left from making the hole. During colder periods most ice anglers choose to carry a heater of some type. The heater is for warmth and it also keeps an anglers fishing hole from freezing. When temperatures reach −20° F. or colder it becomes very hard to keep a fishing hole open. [0005] Three main types of fishing occur. Small, light fishing rod with small, brightly colored lures or jigs with bait such as waxworms, fat heads or crappie minnows. Tip-ups, which carry a line attached to a flag which “tips up” when a strike occurs, allow unattended or less-intensive fishing. The line is dragged in by hand with no reel. In spear fishing a large hole is cut in the ice and fish decoys may be deployed. The fisherman sits in a dark ice shanty called a dark house. The fisherman then peers into the water while holding a large spear attached to a line waiting for fish to appear. This method is often used for lake sturgeon fishing. In the United States, many states allow only rough fish to be taken while spear fishing. [0006] Becoming increasingly popular is the use of a flasher, similar to its summer cousin the fish finder. This is a sonar system providing depth information, as well as indicating the presence of fish or other objects. These flashers, unlike most typical fish finders, display the movement of fish and other objects almost instantaneously. The bait being used can often be seen as a mark on the flasher, enabling the angler to position the bait right in front of the fish. Underwater cameras are also now available which allow the user to view the fish and observe their reaction to the lure presentation. [0007] Longer fishing expeditions can be mounted with simple structures. Larger, heated structures can make multi-day fishing trips possible, but these are eschewed by many seasoned fishers, who fish with no protective structure, attired only in heavy winter wear. [0008] A structure with various local names, but often called an ice shanty, ice shack, fish house, shack, bobhouse, or ice hut, is sometimes used. These are dragged or trailered onto the lake using a vehicle such as a snowmobile, ATV or truck. The two most commonly used types are portable and permanent. The portable houses are often made of a heavy material which is usually water tight. The two most common types of portable houses are when your shelter flips behind the user when not needed, or a pop up shelter so the only means out is through a door. The permanent shelters are made of wood or metal and usually have wheels for easy transport. They can be as basic as a bunk heater and holes or having satellite TV, bathrooms, stoves, full size beds and may appear to be more like a mobile home than a fishing house. [0009] In North America, ice fishing is often a social activity. Some resorts have fish houses rented out by the day, often; shuttle service via Snow Track or other vehicles modified to drive on ice is provided. In Finland, solitary and contemplative isolation is often the object of the pastime. In Finland, fishhouses are a rare occurrence, but wearing a sealed and insulated drysuit designed of space-age fabric is not. In North America, houses appear to create a city at locations where fishing is best. [0010] When fishing in a trap-style portable ice shelter the user typically has ice as the floor. The ice, of course, can be very slippery and can melt when using a heater in the portable ice shelter. Prior trap-style portable shelters typically have a pull-over shelter with no floor. The ice can make entering and exiting the shelter dangerous as a slip hazard. [0011] There currently exist portable ice shelters having floors, however they cannot be used for the trap-style ice shelters. [0012] The present invention is different from the cabin-style ice shelter floors because it isn't attached to the ice shelters. It is lightweight and removable and can be used separately from the trap-style ice shelter. There isn't a removable, foldable floor on the market to be used with the trap-style portable ice shelters. Our two containers provide storage and convenience for transporting fishing equipment and live bait to and from your ice shelter. Past containers were placed behind the seats of the ice shelter which made organization and access hard to achieve. [0013] Further, a fisherman would typically need many storage buckets to transport bait and fishing equipment. There are current containers/tackle boxes used for transporting fishing equipment and bait; however, they do not allow easy access to the equipment without the angler needing to reach behind himself or even get up and move. Present containers further do not allow for an angler's equipment to remain stored until the next time they fish. [0014] It would be desirable to have a floor for ice fishing which would insulate the fisherman from the cold of the ice, prevent the fisherman from slipping on the ice and provide precut holes for directly drilling fishing holes in the ice. It would be desirable to have a floor for ice fishing which was portable. It would be desirable to have a chest for carrying bait and other fishing implements. It would be desirable to have a chest having lighting for shinning on an ice hole. It would be desirable to have a fishing chest having holders for ice fishing rods. SUMMARY OF THE INVENTION [0015] In some embodiments, a portable floor may include one or more of the following features: (a) a pre-cut hole for an ice fishing auger, (b) at least one handle attached to the top surface, (c) a plug to fit into and cover the pre-cut hole, and (d) a slot in a portion of the plug. [0016] In some embodiments, a portable floor may include one or more of the following features: (a) a frame having a top surface and a bottom surface, (b) a pre-cut hole in the floor adapted to allow a ice-fishing auger, (c) a plug to cover the at least one hole, (d) a container which is attachable to the floor, the container having a hinged top lid providing access to the interior of the container and a fishing rod holder, (e) an insulated material located adjacent to the frame, (f) a non-slip material coupled to the top surface, and (g) a means for coupling the container to the floor. [0017] In some embodiments, a container may include one or more of the following features: (a) a door providing access to the interior of the container, (b) a handle, (c) a fishing rod holder, (d) a battery-powered light protruding from an exterior of the container, (e) a removable false bottom, (f) an additional sealable compartment disposed in the interior of the container for accommodating live fishing bait, (g) at least one cup holder attached to the exterior of the container, and (h) a locking mechanism on the hinged top lid for securing the container lid. DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 shows a trap-style ice fishing house in an embodiment of the present invention; [0019] FIG. 2 shows a portable ice fishing floor in an embodiment of the present invention; [0020] FIG. 3 shows a portable ice fishing floor in an embodiment of the present invention; [0021] FIG. 4 shows a portable ice fishing floor in an embodiment of the present invention; [0022] FIG. 5 shows an upper front profile view of containers in an embodiment of the present invention; [0023] FIG. 6 shows a rearview profile view of containers in an embodiment of the present invention; [0024] FIG. 7 shows atop profile view of a container in an embodiment of the present invention; and [0025] FIG. 8 shows a top profile view of a container in an embodiment of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENT [0026] The following discussion is presented to enable a person skilled in the art to make and use the present teachings. Various modifications to the illustrated embodiments will be readily apparent to those skilled in the art, and the generic principles herein may be applied to other embodiments and applications without departing from the present teachings. Thus, the present teachings are not intended to be limited to embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein. The following detailed description is to be read with reference to the figures, in which like elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the present teachings. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of the present teachings. [0027] Embodiments of the present invention disclose a fold-up floor designed for trap-style portable ice shelters. Embodiments of the present invention provide relief from sitting on the ice. Embodiments of the present invention help insulate and provide a non-slip surface for entering and exiting an ice shelter. The fold-up floor could also be used as a flotation device if the user ever fell through the ice. The floor could also be used for fisherman without a shelter who wish to fish directly on the ice. Embodiments of the present invention can fold in half and fit into a case for an ice shelter making it convenient and easy to transport two storage containers used for transporting equipment, rods, live bait and lights. [0028] Embodiments of the present invention disclose a removable, foldable and insulated floor which can fold and fit in a sled base of a trap-style portable ice shelter. Embodiments of the present invention also disclose storage containers used for transportation of fishing equipment and live baits (e.g., minnows). [0029] Embodiments of the present invention disclose a foldable floor and two containers. The floor provides utility, warmth, safety and comfort. One container provides a portable way to transport live bait. Another container can provide a portable way to transport fishing equipment and rods to and from the ice house. The containers can set up on the floor providing the comforts of a permanent ice house without losing the versatility of a portable ice shelter. [0030] Embodiments of the present invention provide a safe non-slip floor ice fisherman can use with or without trap-style ice shelters. The containers can limit the amount of cases or buckets needed to house fishing equipment and rods. The containers can be removable and fishing equipment can remain stored until the next outing. Another container can be a portable bait bucket allowing anglers to use multiple kinds of bait. Bait can be stored in the container until the fisherman's next outing. The floor can be transported within an ice shelter and the containers can eliminate the need for other storage containers. Everything you need for ice fishing would be contained and transported in our prototype. [0031] With reference to FIG. 1 , a trap-style ice fishing house in an embodiment of the present invention is shown. Trap-style icehouse 10 (icehouse) is a portable icehouse. Icehouse 10 typically folds from front 12 to back 14 in an accordion-like fashion along a metal frame 16 . Icehouse 10 is shown fully erected; however, when icehouse 10 is broken down, as just described, it is typically small enough to be stored in tub 18 shown at the back of icehouse 10 . Tub 18 typically can support chairs 20 and allow the angler to store other items within tub 18 . Also shown in FIG. 1 , and in accordance with embodiments of the present invention is a portable ice fishing floor 22 (floor) and portable ice fishing containers 24 and 26 . [0032] With reference to FIG. 2 , a portable ice fishing floor in an embodiment of the present invention is shown. Floor 22 is shown being substantially square; however, it is fully contemplated floor 22 could be most any shape, such as circular, triangular, rectangular or oval, without departing from the spirit of the invention. Floor 22 can have a handle 28 to make it easy for an angler to lift floor 22 off the ice when the angler is finished ice fishing. When picking up floor 22 for transport, floor 22 will typically fold in half along axis 30 which runs from side 32 to opposite side 34 . Also shown are plugs 36 which cover ice fishing precut holes 38 . FIG. 2 shows 4 precut holes 38 ; however, it is fully contemplated most any realistic number of precut holes 38 could be within floor 22 without departing from the spirit of the invention. Further, precut holes 38 could be arranged in most any geometric fashion, besides as shown in FIG. 2 . Precut holes could be placed anywhere on floor 22 . [0033] As shown in the background icehouse 10 is shown broke down and placed within tub 18 for easy transport for the angler. [0034] With reference to FIG. 3 , a portable ice fishing floor in an embodiment of the present invention is shown. Plugs 36 are shown removed to better show precut holes 38 . Precut holes 38 have an indented ridge 40 which runs along the periphery of precut holes 38 . Ridges 40 provide a ledge for plugs 36 to rest upon and allow plugs 36 to run smooth with floor 22 . Ridges 40 can also have a fastener, such as Velcro 42 , to hold plugs 36 within precut holes 38 . Plugs 36 can have a slot 44 within the body of plugs 36 to allow for the angler to easy remove plugs 36 from holes 38 when the angler would like to use floor 22 . It is fully contemplated other methods of removal for plugs 36 besides a slot 44 could be used without departing from the spirit of the invention, such as a string attached to a hole in plug 36 . Covering floor 22 can be a non-slip material 46 to prevent an angler from slipping should water get on floor 22 . Most any non-slip surface, such as a water resistant carpet, could be used without departing from the spirit of the invention. [0035] In use, the angler could set floor 22 on the ice. After removing plugs 36 , the angler could drill a hole though the ice through precut holes 38 with an auger. The ice removed by the auger could then be pushed off of floor 22 . Precut holes 38 are typically 12″ in diameter, which is plenty of room to allow most augers to drill a hole though the ice. However, it is fully contemplated precut holes 38 could be most any diameter within reason without departing from the spirit of the invention. Icehouse 10 can be raised and the angler is ready to go fishing which still keeping warm with an insulated floor beneath him and feel safe from slipping with non-slip flooring 46 . [0036] With reference to FIG. 4 , a portable ice fishing floor in an embodiment of the present invention is shown. Floor 22 has been folded in half and placed within tub 18 for easy transport. Floor 22 fits nicely within tub 18 . Floor 22 can be manufactured to fit with most any portable icehouse manufactures transportation device, such as tub 18 . With bottom side 48 exposed frame 50 is shown having a platform 52 on top of frame 50 . Frame 50 could be made from most any material, such as wood or metal; however, the inventors have found plastic to make floor 22 lighter and thus easier to transport. Platform 52 could also be made of most any material, such as wood or metal, but the inventor's have found plastic assists in making floor 22 lighter. An insulated plastic could be used to assist in keeping the cold of the ice away from the angler and yet also protecting the ice from melting should the angler have a heater in icehouse 10 . It is also contemplated an additional layer of insulation could be attached to bottom side 48 should frame 50 and platform 52 be made of other non-insulated materials. [0037] With reference to FIG. 5 , an upper front profile view of containers in an embodiment of the present invention is shown. Lower container 60 and upper container 62 can be coupled to floor 22 or used separately. Lower container 60 can be coupled to floor 22 by most any means such as Velcro, a peg and slot fitting or even fastened with a bolt. Most any type of attachment is fully contemplated without departing from the spirit of the invention. Both containers 60 and 62 can have adjustable pivoting lights 64 which can be powered by a battery within container 60 or 62 . Typically, lights 64 could be focused upon most any ice fishing hole to provide a better visual fishing experience for the angler, especially if the angler is fishing at night. Containers 60 and 62 can also have other amenities such as cup holders 66 , an ashtray 68 or even fishing pole holders 70 . Each container has a door 72 which pivots upon an axis 74 . Each container 60 and 62 has handles 76 which allow the angler to easily carry both container 60 and 62 to and from the fishing events. [0038] Container 60 is approximately 13″ inches across and lengthwise. Container 62 is approximately 13″ inches across and 16″ lengthwise. [0039] With reference to FIG. 6 , a rearview profile view of containers in an embodiment of the present invention is shown. Coupled to the rear of container 62 can be a rod holder 80 for holding fishing rods 82 . [0040] With reference to FIGS. 7 and 8 , a top profile view of a container in an embodiment of the present invention is shown. Container 62 has a false bottom 90 which can be pulled from container 62 . Underneath of false bottom 90 is a storage space for a battery (not shown) which can power lights 64 . Other items can be stored below false bottom 90 as well. In FIG. 8 , a bait holder 100 is shown. Bait holder 100 can hold most any type of bait for extended periods of time. [0041] Thus, embodiments of the ICE FISHING UTILITIES are disclosed. One skilled in the art will appreciate the present teachings can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for functions of illustration and not limitation, and the present teachings are limited only by the claims follow.

In some embodiments, a portable floor may include one or more of the following features: (a) a frame having a top surface and a bottom surface, (b) a pre-cut hole in the floor adapted to allow a ice-fishing auger, (c) a plug to cover the at least one hole, (d) a container which is attachable to the floor, the container having a hinged top lid providing access to the interior of the container and a fishing rod holder, (e) an insulated material located adjacent to the frame, (f) a non-slip material coupled to the top surface, (g) a means for coupling the container to the floor, (h) a container to store live bait, (i) lights protruding from containers, and (j) cup holders.

BACKGROUND OF THE INVENTION [0001] The present invention relates in general to infant care devices, and more particularly, to a portable diaper changing station and method of using same. [0002] Changing an infant or young child's diaper can be a somewhat difficult task, even when the changing location is within a home where abundant water and waste facilities are present to accomplish the task. Generally, diaper changing stations and tables designed as furniture items and are kept in the nursery or other bedroom and are not easily moved from one location to another. Changing an infant in the home typically requires the caretaker to carry the baby to the location in the house where the changing table and related changing accessories, such as diaper wipes, diapers and baby lotions, are kept. This involves multiple trips to the changing location every day until the need for diapers no longer exists. In homes with multiple levels, climbing up and down the stairs can be quite exhausting for the caretaker. [0003] In today's mobile society, infants travel quite frequently with their parents and caretakers. Many families with infants and small children tend to consume a greater number of meals at restaurants and other public venues, instead of dining at home most of the time. Infants spend more time travelling in cars, trains, airplanes and other forms of transport with their parents and caretakers. Although some public places such as airports and restaurants may have a changing station located in a restroom or other accommodation to visitors, they may become unsanitary due to repeated use without regular cleaning. Likewise they may be positioned in such an area as to make changing a diaper inconvenient and embarrassing. Lugging around a heavy changing station to provide a secure and clean changing surface for the infant, in addition to carrying a diaper bag to store the other accoutrements of child care and diaper changes, makes changing a diaper in a public venue all the more difficult and taxing. Moreover, locating a safe, flat and clean surface on which to change an infant's diaper are relatively few in public venues. [0004] Thus, there is a need for a device which provides a portable, safe, comfortable and secure surface on which a diaper change can be accomplished. There is also a need for a device which is lightweight and can be easily transported and put away for storage when not in use. There is also a need for a portable changing station which can also provide storage and interchangeable tubs for infant care related accessories such as diapers, wipes and other infant related goods. [0005] Therefore, in view of the above it is one object of the present invention to provide a lightweight, portable diaper changing station which can be easily cleaned and sanitized. [0006] A further object of the present invention is to provide a diaper changing station that will provide a soft, clean and comfortable surface on which to place the infant or young child, and which will substantially secure the infant or young child during the diaper change process. [0007] A further object of the present invention is to provide a portable diaper changing station that includes storage capacity for related cleaning items, such as tubs, wipes, lotions and clean diapers which can be stored, exchanged and carried in the changing station. SUMMARY OF THE INVENTION [0008] In accordance with the present invention, an apparatus and method for a portable diaper changing station is disclosed herein. The diaper changing station of the present invention includes a composite, shaped and contoured one piece body member including an integrated handle with a grip. One or multiple, storage compartments with lids may be formed into the body member for storing changing supplies such as tubs, diapers, wipes and powders. In one embodiment, the changing station is generally rectangular in shape, semi-rigid and comprises a nonporous contoured changing surface. A shaped, contoured nonporous head rest may also be formed into the body member. [0009] Other technical advantages of the present invention will be readily apparent to one skilled in the art from the following figures, descriptions and claims. While specific advantages and embodiments have been enumerated above, various embodiments may include all, some, or none of the enumerated advantages. BRIEF DESCRIPTION OF THE DRAWINGS [0010] The novel features believed characteristic of the invention are set forth in the appended claims. The invention itself, however, as well as a preferred mode of use, further objectives and advantages thereof, will be best understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying drawings, wherein: [0011] FIG. 1 is a perspective view of the portable changing station apparatus in accordance with the present invention; [0012] FIG. 2 is top view of the portable changing station apparatus in accordance with the present invention; [0013] FIG. 3 is a bottom view of the portable changing station apparatus in accordance with the present invention; [0014] FIG. 4 is a left side view of the portable changing station apparatus in accordance with the present invention; [0015] FIG. 5 is a right side view of the portable changing station apparatus in accordance with the present invention; [0016] FIG. 6 is a front view of the portable changing station apparatus in accordance with the present invention; and, [0017] FIG. 7 is a back view of the portable changing station apparatus in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION [0018] For purposes of teaching and discussion, it is useful to provide some overview as to the way in which the invention disclosed herein operates. The following information may be viewed as a basis from which the present invention may by properly explained. Such information is offered for purposes of explanation only and, accordingly, should not be construed to limit the broad scope of the present invention and its potential applications. [0019] Turning to FIG. 1 , changing station 10 is shown in a perspective view. In the depicted embodiment, changing station 10 is a one piece, formed body which is generally shaped in a rectangular fashion as shown. In one embodiment, changing station 10 is manufactured by a plastic mold injection process which produces a station body 12 that is nonporous, rigid or semi-rigid as preferred by the user. In one embodiment, station body 12 is constructed of a one piece, non-porous, semi-rigid polyurethane foam with a density of 55 and a durometer hardness of 35. A plastic “skin” is created on the surface of the molded foam station body 12 and changing surface 14 during the manufacturing process of station 10 to resist absorption and staining and which is easily cleaned and sanitized after use. Such material may be easily manufactured with a wide degree of color, texture, shapes and designs integrated therewith. [0020] In alternative embodiments, changing station 10 may be constructed from various plastics, foams, metal, metal alloys, wood or other suitable materials as known in the art. Station body 12 , changing surface 14 and headrest 16 may also include antimicrobial additives in the polyurethane resin to resist and deter microbial growth and odor. In other contemplated embodiments, changing station 10 may consist of two or more members comprising components of the station body 12 , changing surface 14 or headrest 16 . Changing surface 14 is contoured in shape to provide a secure and easily sanitized surface on which to lay and secure the infant or child being changed. Head support 16 is contoured and shaped accordingly to provide a secure and comfortable depression in which to place the child's head while changing the child's diaper. [0021] Handle 18 is formed into the station body 12 for purposes of easily carrying and manipulating the changing station 10 . Handle 18 includes a formed grip which provides a safe and secure grip for the user to easily transport and manipulated the changing station 10 . The grip may consist of the same material as that of station body 12 or may be other materials such as rubber, notched rubber, metal, or other gripping material as known in the art. In one embodiment, handle is substantially formed and located in proximity to the center of gravity of changing station 10 to provide substantial balance while station 10 is being carried. [0022] Various configurable and removable dispenser and storage tubs or compartments may be formed into the changing station 10 for a variety of purposes. In the depicted embodiment, dispenser 20 is a compartment designed to accept sanitary wipes and includes a snap closure lid that includes a slot for the dispensation of wipes, tissues or other dispensable items. In one embodiment, the dispensing tub includes a cap with a lanyard attachment point to secure the dispensing tub cap to the tub cover. Storage compartment 22 is shown with a snap closure lid which provides a secure compartment in which to store associated items such as lotions, gels, pacifiers, toys and/or additional diapers. In alternative embodiments, dispenser 20 and storage compartment 22 may be switched, moved or removed in relative location on or about the station body 12 or away completely detached from the station 10 for purposes of cleaning or restocking wipes and other related supplies. In other embodiments, dispenser 20 and storage compartment 22 include lids with various known means of detachably securing the lid including snaps, buttons, hook and loop fasteners among others. In one embodiment, dispenser 20 or storage compartment 22 are sized dimensionally to accept common tubs which hold wipes or other items to allow a user to remove the tub from the dispenser 20 or compartment 22 , discard the spent tub (e.g. after all the wipes have been used) and replace into dispenser 20 or compartment 22 a new tub of wipes or other supplies as needed. [0023] In the depicted embodiment, safety belt attachment points 24 are preformed slots in station body 12 of sufficient dimension to accept a safety belt which may be draped across the body of a child who has been placed on changing surface 14 for purposes of substantially securing the child to the changing station. In other embodiments, safety belt attachment points 24 may comprise loops, rings, hook and loop fasteners, or snaps or other commonly know means for securing a belt or harness to changing station 10 . Additional safety device retention systems or attachment points may be integrated on station boyd 12 as desired. [0024] FIG. 2 is a top view of one embodiment of the invention disclosed herein. Station body 12 is shown with safety belt attachment point 24 . Storage lid 30 and dispenser lid 34 are shown detachably secured to station body 12 with hinges 32 , 36 . In one embodiment, lids 30 , 34 are molded with a “living” hinge feature or other known safety hinge design to eliminate potential pinch points. Lids 30 , 34 may also be detachably secured to station body 12 via spring hinges, torque hinges, snaps, hook and loop fasteners or attachment means as known in the art. In the depicted embodiment, dispenser lid 34 includes a slot for dispensing wipes or any other material or object designed to be easily withdrawn without the need for opening the entire lid. [0025] With reference to FIG. 3 , lids 30 , 34 are shown with tabs 40 integrated therewith. Tabs 40 allow the user to easily lift and open lids 30 , 34 with their fingers or hands. Instead of tabs 40 , other pulls or knobs may be utilized according to the preference of the user. [0026] Turning to FIG. 4 and FIG. 5 , left and right side views of the changing station 10 are shown. The substantial contour of changing surface 14 is shown and, as previously described, acts to substantially secure a child placed thereon to keep the child from “rolling” out of the changing station 10 . The contour of changing surface 14 also acts to contain any spills or other materials and substantially prevent the spills or other materials from leaking on to other surfaces in proximity of the changing station 10 . Lids 30 , 34 are shown in a “closed” position. Tabs 40 are shown as configured in the closed position of lids 30 , 34 . [0027] FIG. 6 is a front view of the changing station 10 in one embodiment disclosed herein. Station body 12 is shown with contoured changing surface 14 and headrest 16 . Headrest 16 is preformed into station body 12 and is of sufficient size and dimension to provide a comfortable and secure head rest for a child placed on to the changing surface 14 . In the depicted embodiment, headrest 16 is a contoured, generally oval depression which is formed into the station body 12 and changing surface 14 . In other embodiments, headrest 16 may consist of various geometric shapes and forms, as well as be raised above the horizontal plane of changing surface 14 . Indeed, it is contemplated, that various dimensional configurations for station body 12 , changing surface 14 and headrest 16 may be designed and utilized for infants and children of various ages, sizes and needs. [0028] Compartments 20 and 22 are shown in a closed position. It is also recognized that compartments 20 and 22 may be designed and utilized for various specific requirements. In the embodiment shown, compartment 20 is a wipe dispenser and compartment 22 is designed to contain various items such as baby lotion, medications or other objects. Other embodiments of the invention disclosed herein may not incorporate one or any storage compartment. In still other possible embodiments, multiple compartments may be integrated into station body 12 at any location and as desired. Likewise, safety belt attachment points 24 may or may not be formed into station body 12 as desired by the user. Handle 18 or another suitable transport attachment may or may not be formed as required or desired by the user. It is contemplated that end users could design and customize the size, shape, color, and storage features to the changing station 10 to suit their individual preferences and needs. In alternative embodiments, various lugs, pulls, straps or other handling means may be incorporated or formed into station body 12 and utilized for transport of the changing station as desired by the user. Likewise, various storage solutions may or may not be incorporated as desired. [0029] FIG. 7 is a back view of the changing station 10 apparatus disclosed herein. In one embodiment, station rests 50 and cleats 52 are formed as convex and protruding up and away from the horizontal plane of station body 12 . In the depicted embodiment, station rests 50 are substantially larger in diameter than cleats 52 . Station rests 50 act to provide a stable support for the changing station when the changing station is placed on a surface. In an alternative embodiment, rests 50 are formed or cut into station body 12 to prevent station body from creating suction with, sticking to or substantially clinging to any surface upon which the changing station 10 is placed for use in changing a diaper or during storage. Cleats 52 act to provide a friction and/or restriction mechanism when cleats 52 come into contact with any surface or objects resting on a surface on which the changing station 10 is placed. Cleats 52 also act to reduce the surface area of station body 12 which comes into contact with the support surface, thereby making it easier to lift the changing station 10 off and away from the supporting surface. If changing station 10 is placed on an uneven or substantially contoured surface, station rests 50 and cleats 52 will act to provide stability to the changing station. Station rests 50 and cleats 52 may consist of or be covered with non-slip or rubberized materials to reduce slipping of the station and to prevent the marring of the surface on which the station rests. In one embodiment, station rests 50 and cleats 52 are formed as concave dimples into the station body 12 and may act as suction cups to secure the changing station 10 to a flat surface or may be fashioned and constructed to reduce the suction between the station and the surface upon which the station is placed. In still other embodiments, rests 50 and cleats 52 may be formed in mixed concave and convex shapes as desired to provide support, suction, anti-suction or other function as desired to assist in supporting the station 10 and detachably securing it to a variety support surfaces with various topographic environments. [0030] A method of changing a child's diaper using the portable changing station 10 is as follows. The changing station 10 is placed on a surface which can properly support the station 10 and the child placed thereon. The child is then placed on the station body 12 resting substantially on changing surface 14 which provides a soft and secure area for the child while the child's diaper is being changed. A belt or other retention device may be looped over the child's torso to further releasably secure or restrict the child from gross movement during the changing process. The soiled diaper is removed and discarded into an appropriate receptacle. Wipes may be dispensed from the wipe dispenser 20 to clean the child and any portion of the station 10 which may have become soiled during the changing process. Topical medication or lotions may be withdrawn from storage compartment 22 and replaced after use. In one embodiment, the user may withdraw a tub of wipes from the dispenser 20 and place them in a more convenient area while changing the diaper. After the change is complete, the user may replace the tub into dispenser 20 for transport and later use. [0031] The advantages of the portable changing station 10 are readily apparent. Station 10 is a lightweight and can be easily transported. Station 10 provides a secure and sanitary surface on which to safely and quickly change a diaper. Station 10 is easily cleaned and sanitized after each use or as necessitated and provides a storage capability for items which are required or facilitate the changing of a diaper. Due to the contoured shape of the changing surface 14 and headrest 16 , changing a diaper can be carried out relatively safely because the potential for the child to fall or roll off the station 10 is minimized. Station 10 is easily customized to suit the preferences of the user including functionality (right handed vs. left handed users) and personal taste (e.g. color or artwork imprints). [0032] While the invention has been particularly shown and described with reference to a various embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.

The portable diaper changing station of the present invention comprises a composite, nonporous shaped body member which is contoured to provide a secure changing surface. A carry handle may be integrated into the body member along with at least one storage compartment for the storage of changing supplies such as diapers, wipes and powders. In one embodiment, the changing station is generally rectangular in shape, rigid and includes a nonporous contoured changing surface with a shaped contoured pad running a substantial length of the contoured changing surface. A shaped nonporous head rest is contoured and formed therein.

The invention relates to a fluid pump and a measuring chamber. BACKGROUND OF THE INVENTION Patent specification DE 195 25 926 C1 discloses a peristaltic pump system in which a measuring device is inserted into the pump system hose line after the pump. This measuring device downstream of the pump determines the fluid transport volume of the pump by pressure measurement. In this case the measuring device is built up in simple manner as a block so that it can be removed from a mounting in order that the test housing can be disinfected without complication. At the same time the fluid pressure is transmitted from the interior of the test housing to the outside via openings which are covered tightly by a membrane. In so doing the test housings can be built up of reusable measuring chambers to be disinfected, or alternatively, of single-use products packed in a sterile manner. Due, however, to the removability of the measuring chamber or the design of the measuring chamber as a separate, exchangeable accessory part, a critical and serious disadvantage, especially in the field of medicine, arises in that a measuring chamber which is actually destined and suitable for a certain first pump system is inadvertently employed in a different pump system, the result of which may be that the proper functioning of the latter pump system may be put into question. This is especially the case, for example, when pump systems with their respective measuring chambers are on hand from different manufacturers as accessories and the measuring chambers from a first manufacturer can be inserted into the pump systems of a different manufacturer (such as when the external dimensions of the measuring chambers from the different manufacturers are identical to one another) but pressure measuring properties of the measuring chambers differ from manufacturer to manufacturer. This can cause faulty operation of the pump systems. SUMMARY OF THE INVENTION Accordingly, it is the object of the present invention to specify a fluid pump having a pressure measuring chamber and a pressure measuring chamber therefor which is particularly simple and robust to handle in clinical practice, for which the measuring chambers are particularly inexpensive to manufacture in industrial mass production and wherein the inadvertent use of a measuring chamber in a pump unsuitable for this measuring chamber is prevented. These tasks are solved according to the invention by a fluid pump and a measuring chamber. The invention exhibits the following advantageous characteristics. Due to the fact that code value carrier means are provided on the measuring chamber of the fluid pump according to the invention, a particular advantage is achieved that code values can be entered into these code value carrier means and hence the measuring chamber can be individualized Such code values can be alphanumeric values or other values which carry information about the type and/or performance characteristics of the measuring chamber or its manufacturer. Due to the fact that during and/or after fixing of the measuring chamber on the pump housing of the fluid pump—for example by insertion into a holding device in the fluid pump—the code value carrier means can be recorded by the read-out means of the fluid pump, a particularly unpractical additional work step in the practical clinical field is avoided from the outset for example, establishing an electric cable connection between the code value carrier means and the fluid pump, or for instance the manual read-out of a scanning code applied to the housing of the measuring chamber by a manual scanner connected to the fluid pump. Due to the fact that read-out means are provided, which can read out the code value from the code value carrier means, the fluid pump can match its operational behavior to the measuring chamber employed according to the code value entered into the code value carrier means on the measuring chamber. This matching can consist, for example, in a change in the transport behavior of the pump or preventing the pump from operating. The ability to attache the pressure measuring chamber on to the pump housing can be achieved, for instance, by configuring the housing of the measuring chamber and the fluid pump in such a way that the measuring chamber is insertable into a holding device on the fluid pump. Thus, it is particularly easy to fit the measuring chamber into a tube line without additional fastening effort and to remove it again without appreciably increasing the length of the tube line in doing so. Such a housing design can be achieved, for instance, by providing a box-shaped housing having a smooth and robust surface which is scratch-proof and resistant to fracture, and in which fragile outer parts are avoided. Advantageous refinements of the invention are possible according to the subsidiary claims referring back to the latter and are explained below. The adaptation of the pump behavior is brought about by the functions of the control means of the fluid pump which control the behavior of the fluid pump as a function of the code value recorded by the read-out means and held in the code value carrier means of the measuring chamber. In this way it is possible to control the operating behavior of the pump by using different code values when using different measuring chambers having at least externally identical geometric dimensions. For instance, a first measuring chamber having a first code value can trigger the transport properties of the pump for interventions in the field of the central nervous system, and wherein a second measuring chamber having a second code value in the same fluid pump can trigger the transport properties for endoscopic interventions in the knee. In this way erroneous use of a measuring chamber not belonging to the pump can be effectively prevented, which can prevent for example, the pressure of the transported fluid, and hence its transport flow rate, from being wrongly determined, or a measuring chamber being used in association with the fluid pump which does not meet the properties demanded and specified by the pump manufacturer. A particularly simple implementation of the interplay of the code value carrier means of the measuring chamber and read-out means of the fluid pump is to implement the code value carrier means as one or more, for example, pin shaped profiles on the measuring chamber housing, which due to a suitably complementary profile in the pump housing, allow the measuring chamber to be attached to the pump housing only when the pattern (corresponding to the code value) formed by the pins on the measuring chamber matches that specified by the profiling of the pump housing. The fluid pump can then be implemented in such a way that it can be operated only when a measuring chamber is completely attached to it. Other methods of implementing the control means, especially when they involve functions suitable for the purpose of electronic control, having the read-out means detect a code value from the code value carrier means and checking the code value by means of a suitable control logic circuit of the fluid pump to see whether this code value (or this number of code values) agrees with the code value(s) expected by the control logic circuit. Thus, by simply inserting a measuring chamber coded in suitable manner, the transport behavior of the fluid pump can be adapted according to the desired medicinal use or blockage of the pump can be triggered so that safe operation of the pump can be ensured. A particularly advantageous method of implementation is when the code value carrier means contain means for optical and/or electric and/or magnetic and/or mechanical code value storage, and also means for transmitting a code value in one of the aforesaid ways insofar as these cannot be read out directly from the code value carrier means by the read-out means of the fluid pump. In doing so the read-out means need not necessarily embody the same principle of implementation as the code value carrier means, but can be adapted to these. Thus, it is conceivable, for instance, to have mechanical code value storage by means of prominences on the housing of the measuring chamber which are detected optically, or alternatively, by mechanical scanning of a magnetic storage system. It is particularly advantageous for the code value contained in the code value carrier means—a plurality of code values simultaneously is equally conceivable—represent information relating to the physical properties of the measuring chamber(such as flow cross-section of the transported fluid or cross section of the measuring nozzle) and/or relate to the manufacturer (measuring chamber manufacturer or fluid pump manufacturer) and/or relate to the intended mode of operation of the pump (such as desired transport volume; or permitted transport tolerance in different medicinal applications). A practical and particularly low-cost variant for implementing the coding means is, for instance, to provide on the housing of the measuring chamber mechanically scanable prominences and/or depressions and/or excavations. This provides a low-cost and robust solution for the code value carrier means whose serviceability is not impaired by moisture and/or chemicals, radiation and heat. If the code value carrier means are arranged on one side of the measuring chamber housing so that they come into direct contact with the read-out means of the fluid pump, the scanning of the code pins can take place by means of electric pressure contacts, such as a pressure sensitive keyboard for instance. Particularly advantageous is to arrange the code value carrier means and read-out means in such a way that they are placed in effective contact with one another directly by attaching the measuring chamber on or in the housing of the fluid pump, without further action. Other methods of implementation are also conceivable, however such as use of a barcode as the code value carrier means and a barcode reader as the read-out means of the fluid pump, as well as representing the code value in the code value carrier means by colors In these two forms of coding it is advantageous that the barcode or the colors, as an implementation of the code value carrier means, afford a very low-cost method of implementation on the part of the measuring chamber. This is important because the measuring chamber, in comparison with the fluid pump, are produced in very large numbers. A somewhat more costly method of implementation provides for an integrated circuit as the code value, carrier means in which circuit. At least one code value is stored in the integrated circuit. This method is advantageous in that the number of code values, or the information contained in the code value, can be much more extensive. A particularly advantageous method of implementation is to transmit the code value from the code value carrier means to the read-out means by electromagnetic signals. With regard to the practical clinical use of the measuring chambers, it is particularly advantageous to provide the housing of the measuring chamber with means for the unique identification of the orientation of the housing relative to the fluid pump housing. When attaching the measuring chamber on or in the pump, for example, in a holding device provided for this purpose on or in the pump and by a translational movement of the measuring chamber in the longitudinal direction of the measuring chamber housing, this is a simple way of preventing the measuring chamber from being inserted the wrong way round, in particular with the chamber connected counter to the planned direction of flow in the tubing circuit. By providing such means the user need not take any particular care when inserting the measuring chamber. For example, the attaching means can take the form of a special shape for the housing that compliments the shape on the fluid pump, such as, for instance, the use of asymmetric geometric features for the housing geometries. A further advantageous refinement of the measuring chamber provides for a membrane on the measuring chamber onto which the pressure from the interior of the measuring chamber can be transmitted through openings provided for this purpose in the measuring chamber housing. The openings are tightly covered by the membrane and the leak-proofness of the membrane prevents the transported fluid from escaping a closed system within the measuring chamber. In combination with the membrane, and in particular with regard to practical use, it is advantageous to equip the measuring chamber with a membrane protector completely covering the membrane, by which means the membrane is reliably protected on the measuring chamber in practical use, such as transport or disinfection, and unintended tearing or bulging of the membrane is prevented. It is particularly advantageous for the membrane protector to be opened by lateral displacement along the measuring chamber housing. For example, the membrane protector can be constructed in such a way that when affixing the measuring chamber to the fluid pump the membrane protector automatically opens to expose the membrane and allow the fluid pump contact with the membrane, such as by fluid sensors in the fluid pump for instance. This in particular avoids the disadvantage of a sheath-like or hood-like cover, which must be put in position or removed with some effort by hand and can easily be lost. In a manner analogous to the automatic opening of the membrane protector upon attaching the measuring chamber to the pump, the membrane protector can be closed upon removal of the measuring chamber from the fluid pump. A particularly practical embodiment for the lateral displaceability of the membrane protector constructed as a plate takes the form of guide rails positioned along the measuring chamber housing which can be implemented as moldings on the measuring chamber housing. By means of the automatic opening and closing of the membrane protector on the measuring chamber when it is fixed on or in the fluid pump there is no need for unwieldy manual pushing aside or removal of the membrane protector or putting it back on which might require the user to use both hands. Another advantageous embodiment of the measuring chamber provides for locking means on the measuring chamber which hold the housing by friction fitting and/or form fitting after it is fixed on a fluid pump. The means of engagement as preferably constructed in such a way that on fixing they produce a clearly perceptible click and fixing and removal can be effected by simple and direct application of translational force, in particular without operation of additional unlocking devices. It is, furthermore, advantageous to provide a pump segment which is fixedly connected by clamping to the measuring chamber on the inlet side. This has the advantage that on each change of measuring chamber this pump segment is also exchanged. This is of particular importance when the drive of the fluid pump constructed as a peristaltic pump is implemented via a roller wheel. Particularly high demands are imposed on the mechanical properties of the pump segment, which is constructed as a flexible tube. These mechanical properties of the pump segment are subject, however, to particularly marked ageing or attrition during use so that regular replacement is required. In the present embodiment this is ensured by the fixed attachment of the pump segment to the measuring chamber. Another advantageous embodiment provides for a flow channel in the measuring chamber, and the construction therein of a measuring nozzle reducing the flow cross-section of the fluid streaming through the flow channel, wherein ahead of and following the measuring nozzle openings are arranged for externalizing the measuring chamber which allow measurement of the pressure. The characteristics of the invention exhibit the following advantageous effects. Due to the fact that the measuring chamber includes a code value carrier means in which at least one code value is present, and includes means for code value storage and transmission to enable the code value to be retrieved in simple manne, the measuring chamber can be individualized and the compatibility of measuring chambers with fluid pumps from different manufacturers can be selectively controlled as described above in more detail. Compatibility and individualization can be provided in this manner without the need for producing differences in the housing or in the mechanically fitted shape which are costly in production terms. By this means the effects of scale in large-scale industrial production are exploited since housing production for all measuring chambers can ensue in the same way according to external dimensions and in this way standardization effects in production arise. Advantageous refinement of the invention is possible according to the refinements of the fluid pump relating to the measuring chambers. BRIEF DESCRIPTION OF THE DRAWINGS The invention is explained below with reference to an exemplified embodiment. The drawings show: FIGS. 1 a and 1 b show a wedge-shaped measuring chamber with a membrane in which the membrane protector is in the open and closed state, respectively, and having code value carrier means in the form of code pins; FIGS. 2 a – 2 c show a cut-away view of the measuring chamber from the side of the housing opposite the membrane, a view at right angles to the membrane side, and a view of the membrane side, respectively; FIG. 3 shows a fluid pump constructed in the form of a peristaltic pump having a roller wheel and holding device for accommodating the measuring chamber pushed in from the side; FIG. 4 shows the fluid pump illustrated in FIG. 3 with the measuring chamber illustrated in FIGS. 1 and 2 shown inserted and locked to the fluid pump; FIG. 5 shows a detailed version of the measuring chamber shown in FIG. 1 with guide rails and locking means, wherein in this case the housing shape is a parallelepiped; and FIG. 6 shows a detailed version of the fluid pump shown in FIG. 4 , showing guidance of the pump segment on insertion and stabilization of the measuring chamber. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT FIGS. 1 a and 1 b shown an exemplified embodiment of a measuring chamber according to the invention. The measuring chamber has a block-like housing 1 with a level surface. On one end face of the block-like housing 1 a pump segment 5 is clamped in place, and inserted into the other end face is a tube connection 6 , which together form an extension of a flow channel 7 , not illustrated in more detail in this figure. In accordance with the invention, and as described later in association with FIGS. 3 and 4 , the measuring chamber, or the housing 1 , is pushed into a mounting, which at present is not necessarily fastened to a pump. Likewise on the end face of the housing 1 accommodating the pump segment 5 , there are located code value carrier means 4 implemented in the form of code pins. These code pins contain a code value which, for example, contains the name of the company which produced the measuring chamber and the cross-section of the flow channel in codified form. The code pins 4 are located on the end of the measuring chamber facing the plug-in direction of the measuring chamber when inserting the measuring chamber into a holding device on the fluid pump. In this special case, but not generally, the plug-in direction is the side from which the fluid flows into the measuring chamber. Referring also to FIGS. 2 a – 2 c , membrane 2 can also be seen, which covers openings 8 and 8 ′ between the flow channel and the outside of the measuring chamber. A membrane protector 3 is constructed in the form of a plate which is displaceable to the side, and is guided in stable and secure manner to prevent it slipping out by guide rails 13 projecting from the housing along the sides of membrane protector plate 3 , FIG. 1 a shows the membrane protector 3 in the open state, and FIG. 1 b the measuring chamber with the membrane protector 3 in the closed state. Membrane protector 3 will normally be in the closed position, as shown in FIG. 1 b , when handling the measuring chamber while removed from the holding device of a fluid pump A return structure can be provided in the housing I which ensures that, absent a lateral displacement force, the membrane protector 3 always returns to the basic closed state as depicted in FIG. 1 b. FIGS. 2 a – 2 c show the same measuring chamber shown in FIGS. 1 a and 1 b in cut-away from the side ( FIG. 1 a ) located opposite the membrane, in cut-away perpendicular to the membrane side (fig 1 b ), and from the membrane side ( FIG. 1 c ). In FIG. 2 a the pump segment 5 can be seen in the way it is plugged into the inlet of a flow channel 7 . A flow outlet in the form of the tube connector 6 is also clearly visible. FIG. 2 a shows how the membrane surface 2 , illustrated by the continuous line of the rounded rectangle surrounding the area 2 , covers the openings 8 and 8 ′ illustrated as the interior of the dotted rings located therein. Located above this is the membrane protector 3 , which is illustrated by a dotted line. Likewise, illustrated by dotted lines are the code pins 4 in one end faces of the housing. The view in FIG. 2 b , tuned with respect to FIG. 2 a by 90° in the horizontal plane, shows the membrane protector 3 in the guide rails 13 . The guide rails 13 extend to the right outside edge of the measuring chamber so that the membrane protector can be pushed to the right beyond the boundary of the measuring chamber housing. In this view the openings 8 and 8 ′ are also clearly visible, which connect the inside of the membrane 2 (not illustrated in more devil in FIG. 2 b to the flow channel 7 . FIG. 2 c shows the closed membrane protector 3 as a continuous line. Located behind the membrane protector, and shown in dotted lines, is the membrane 2 and the openings 8 and 8 ′ that lead to the flow channel 7 . It also shows how the membrane protector 3 is held in the guide rails 13 . Where the continuous line of the membrane protector plate 3 passes behind the likewise continuous projection overlapping the plate 3 at top and bottom, the continuous line of the membrane protector 3 transitions into a dotted line. A measuring nozzle located between the openings 8 and 8 ′ in the flow channel 7 is not illustrated in more detail, but is readily imaginable, especially in the view in FIG. 2 b between the openings 8 and 8 ′, as a tapering of the flow channel 7 . FIG. 3 shows an exemplified embodiment of a fluid pump according to the invention, constructed in the form of a peristaltic pump, which in the present case is designed to accommodate the measuring chamber as implemented in the exemplified embodiment in FIGS. 1 and 2 described above, so that the fluid pump and measuring chamber are actively connected according to the invention. Other forms of fluid pumps of providing similar means for connecting to the measuring chamber may contain a drive based on the peristaltic principle but without a roller wheel for producing the peristaltic effect or, furthermore, a drive based on a rotor or impeller driven by magnetism and may also be arranged in the axial direction relative to the transport channel. A design in the form of a gear-type pup having a closed gear chamber is also conceivable. In the present exemplified embodiment in the form of a peristaltic pump, the housing 15 has a roller wheel 9 around which a flexible tube can be placed and measuring chamber can be attached to the holding device 10 . Accordingly, the transport channel is constructed as a tube line. The holding devices 10 are configured as moldings on the pump housing and formed in such a way that they completely accommodate securely encompass the block-like housing 1 of the measuring chamber. The measuring chamber has a prismatic construction with a trapezoidal outline on the membrane side. Accordingly, the holding device 10 have sloping guide surfaces 14 which engage with the sloping side surfaces of the measuring chamber housing. Positioned at the end of the holding device 10 , viewed in the insert direction, is at least one read-out means constructed as a reading contact 11 , which is arranged to work together with the code pins 4 . The at least one reading contact 11 and code pins 4 may also have different embodiments, and may be implemented in a mechanical, for example pins and holes engaging one another, electrical, and/or optical manner. Through mechanical scanning of the corresponding code pin 4 of the measuring chamber, the reading contact 11 is able to read out the single-place code value located therein. In this example, it is checked whether the measuring chamber to be inserted in the mounting 10 is compatible with the pump. The housing 15 of the pump is provided with pressure sensors 12 and 12 ′, which work together with the measuring chamber. The pressure sensors 12 and 12 ′ are arranged in such a way that when the measuring chamber is inserted into the mounting 10 the pressure sensors are placed in direct active contact with the membrane 2 , which is exposed from under its membrane protector 3 when the the measuring chamber is completely pushed in and locked in place in the mounting 10 . With the measuring chamber attached to the mounting 10 , the pressure sensors 12 and 12 ′ are located directly opposite the region of the openings 8 and 8 ′. Locking means, which are not illustrated, are provided for locking the measuring chamber to the holding device 10 . The locking means are fitted on the holding device 10 and/or the housing 1 of the measuring chamber. The presence of only one read-out means 11 , for example, a mechanical scanner for only one code pin, serves only to improve the clarity of presentation. A plurality of read-out means can of course be present, which can advantageously be arranged (as in the implementation of a strip scanner) one above the other in a row as suggested in the illustration of the code pins 4 in FIG. 1 a. FIG. 4 shows the fluid pump illustrated in FIG. 3 with the measuring chamber inserted and locked in position, as illustrated in FIG. 1 a . At the start of the insertion operation the membrane protector 3 is caught by a catch, which is not illustrated in more detail, at the level of the pressure sensors 12 and 12 ′, and held so that the membrane 2 on the measuring chamber is exposed as the insert movement continues. Once the measuring chambers is fully inserted and locked in place, the reading means 11 makes contact with the code value carrier means 4 so that a control means 17 in the system, which may also contain a means for determining the transport volume from the signals of the pressure sensors, determine whether the system is ready for operation and/or in which way the system operates. At the same time the pressure sensors are in active contact via the membrane 2 with the openings 8 and 8 ′. If the measuring chamber is equipped with a suitable return device then, upon unlocking and removing the measuring chamber from the holding device 10 on the fluid pump, the membrane protector 3 advances again over the membrane to protect the membrane without any action by the user. From here the measuring chamber can be collected and disinfected without any special care, which proves to be advantageous especially in practical clinical operations. FIG. 5 shows a more detailed version of the measuring chamber shown in FIGS. 1 a and 1 b , wherein recesses are provided at the right-hand end of guide rails 13 that are engageable with correspondingly shaped right-hand ends of the membrane protector plate 3 in friction fitting manner for securing the position of the membrane protector relative to the body of the measuring chamber. Also illustrated in FIG. 5 are the code value carrier means 4 constructed as code pins, which here take the form of convex, pin-like protruberances on the housing. An engaging means 20 is located on the top or bottom of the measuring chamber housing, which upon attaching the measuring chamber on or in the housing of the fluid pump engage with a clearly perceptible click to-secure the measuring chamber in a friction fitting manner against inadvertent detachment from the fluid pump. The measuring chamber housing further includes an elastic attachment 21 which positions the measuring chamber securely inside the mounting device 10 upon insertion in the holding device. The elastic attachment 21 pushes the measuring chamber located in the mounting toward the sensors to prevent-unintended movement of the measuring chamber housing relative to the fluid pump. FIG. 6 shows how attachment of the measuring chamber to a fluid pump implemented in the form of a peristaltic pump can be carried out. Brought into the position with respect to the pump, the pump segment 5 , which in this figure is shown merely as a short length, but in reality is many times longer, can be gripped by one hand while at the same time the moving the measuring chamber housing connected to the pump segment 5 into the holding device 10 by pulling in the direction of the roller wheel 9 . In the course of this movement the person operating the instrument can guide the pump segment 5 clockwise round the roller wheel 9 into the holding device 15 and finally clamp the pump segment 5 in a locking device 16 . In this way the pump segment 5 is fixed in a stable position and the measuring chamber is fitted securely into the holding device. The elastic attachments 21 ensure that the measuring chamber is pressed against the pressure sensors 12 and 12 ′ for the measuring chamber and prevent unintended slippage, while the locking means 20 produce a clearly perceptible click on engagement as soon as the measuring chamber reaches the fixed position of operational readiness on the fluid pump and further secure the measuring chamber against unintended slippage out of the holding device 11 . Another characteristic of the measuring chamber illustrated in this figure is that it has a label surface 30 for holding information, such as a label bearing the logo of the manufacturer, or other information, for example the field of use of the pump, such as “Only for uteroscopy” for instance.

Fluid pump for medicinal, especially endoscopic, applications having a transport channeled through a drive, a device possessing a measuring chamber for measuring the pressure of the fluid conveyed in the transport channel and control means for the automatic control of the behavior of the pump, in particular its transport behavior, as a function of the measured pressure and as a function of a code value contained in code value carrier means which are provided on or in the measuring chamber, wherein the code value is detected during and/or after fixing of the measuring chamber on the pump housing by read-out means in the fluid pump.

CROSS REFERENCE TO RELATED APPLICATION [0001] N/A FIELD OF THE INVENTION [0002] The invention is related to a multi-purpose catheter that is used to deliver dose, measure the dose and remove human waste while providing an easy connection module. BACKGROUND [0003] In medicine, a catheter is a tube that can be inserted into a body cavity, duct, or vessel. Catheters thereby allow drainage, injection of fluids, or access by surgical instruments. The process of inserting a catheter is catheterization. In most uses, a catheter is a thin, flexible tube (“soft” catheter), though in some uses, it is a larger, solid (“hard”) catheter. A catheter left inside the body, either temporarily or permanently, may be referred to as an indwelling catheter. A permanently inserted catheter may be referred to as a permcath. [0004] The ancient Syrians created catheters from reeds. “Katheter—καθετ{acute over (η)}ρ” originally referred to an instrument that was inserted such as a plug. The word “katheter” in turn came from “kathiemai—ηαθ{acute over (ι)} εμαι” meaning “to sit”. The ancient Greeks inserted a hollow metal tube through the urethra into the bladder to empty it and the tube came to be known as a “katheter”. [0005] Prior catheters were used only for single functions, such as removing human remains and enlarging an area inside the human body. The single functioning catheters requires that a medical personnel remove one catheter and insert another catheter into the patient when multiple functions are required to be performed on the patient. This removal and insertion process creates much discomfort to the patient, because the removal of the tube and insertion of the catheter creates a pain. Also, when multiple catheters need to be inserted into a patient, each catheter is inserted into the patient; however, the catheter's excessive length can cause confusion to the medical personnel, and the medical personnel may perform a function on the wrong catheter resulting in mal-practice. [0006] Thus, the need exists to have a catheter that can provide multiple functions and which is less traumatic than current procedures involving insertion and removal. The present invention meets that need without the risk of causing damage or producing pain. SUMMARY OF THE INVENTION [0007] According to one general aspect, there is A medical device comprising a locking mechanism that is used to connect a plurality of catheters, a multi-balloon inflator that inflates multiple balloons on a single catheter, a extraction point used to remove human fluids from the human body, and a connecting point that allows a syringe or a machine to insert liquid saline solution or radioactive isotopes into said multi-balloon inflator. [0008] The medical device that contains the locking mechanism can be affixed to any male or female connection attached to any type of catheter. [0009] The medical device that contains the said multi-balloon inflator that is connected to each individual said connecting point to allow the volume of inflation. [0010] The medical device that contains the said locking mechanism when affixed to another catheter creates a vacuum seal that does not allow the fluids or any air to pass through any said connecting point. [0011] The medical device that contains the extraction point contains an inner seal within the opening that only allows for a single direction flow for only removal of fluids which does not allow for fluids to be inserted into the human body. [0012] The medical device that contains the extraction point is large enough to contain a measuring device used to measure the amount of dose radiated to human tissue while said extraction point is removing fluids from the human body. [0013] The medical device that contains a medical device that contains a plurality of said multi-balloon inflator wherein at least one said multi-balloon inflator contains radioactive isotopes while the remaining said multi-balloon inflators contains air or any other liquid for inflation of the balloon. [0014] The medical device that contains a plurality of said medical devices can be inserted into both the rectum and urethra with a plurality of said measuring devices take dose measurements while applying dose therapy through said multi-balloon inflator. [0015] According to another general aspect, there is a method of operating a multi-functional catheter, wherein said method comprises connecting a plurality of catheters, inflating multiple balloons on a single catheter, removing human fluids from the human body, and pumping liquid saline solution or radioactive isotopes into said multi-balloon inflator. [0016] The connecting may be affixed to any male or female connection attached to any type of catheter. [0017] The inflating is connected to each individual said connecting point to allow the volume of inflation. [0018] The affixing to another catheter creates a vacuum seal that does not allow the fluids or any air to pass through any said connecting point. [0019] The removing fluids by an inner seal within the opening that only allows for a single direction flow for only removal of fluids which does not allow for fluids to be inserted into the human body. [0020] The removing a measuring device used to measure the amount of dose radiated to human tissue while said extraction point is removing fluids from the human body. [0021] The radiating by a multi-balloon inflator with radioactive isotopes while the other plurality said multi-balloon inflators contains air or any other liquid for inflation of the balloon on a medical device that contains a plurality of said multi-balloon inflator. [0022] A plurality of said medical devices can be inserted into both the rectum and urethra with a plurality of said measuring devices take dose measurements while applying dose therapy through said multi-balloon inflator. DESCRIPTION OF THE DRAWINGS [0023] FIG. 1 is an illustration of a first position rectum balloon attached to first position urethra catheter balloon. [0024] FIG. 2 is an illustration of a first position rectum balloon with a MOSFET™ attached to first position urethra catheter balloon. [0025] FIG. 3 is an illustration of a first position rectum balloon and second position rectum balloon attached to first position urethra catheter balloon. [0026] FIG. 4 is an illustration of a first position rectum balloon and second position rectum balloon with a MOSFET™ attached to first position urethra catheter balloon. [0027] FIG. 5 is an illustration of a first position rectum balloon, a second position radiation balloon, a third position rectum balloon attached to first position urethra catheter balloon. [0028] FIG. 6 is an illustration of a first position rectum balloon, a second position radiation balloon, a third position rectum balloon with MOSFET TM attached to a first position urethra catheter balloon. [0029] FIG. 7 is an illustration of a first position rectum balloon and a second position rectum balloon in the human body and a first position urethra catheter balloon in the human body. [0030] FIG. 8 is an illustration of a first position rectum balloon and a second position rectum balloon attached to first position urethra catheter balloon. [0031] Throughout the drawings and the detailed description, unless otherwise described, the same drawing reference numerals will be understood to refer to the same elements, features, and structures. The relative size and depiction of these elements may be exaggerated for clarity, illustration, and convenience. DETAILED DESCRIPTION [0032] The following detailed description is provided to assist the reader in gaining a comprehensive understanding of the methods, apparatuses and/or systems described herein. Accordingly, various changes, modifications, and equivalents of the systems, apparatuses, and/or methods described herein will likely suggest themselves to those of ordinary skill in the art. Also, descriptions of well-known functions and constructions are omitted to increase clarity and conciseness. [0033] FIG. 1 shows an exemplary sample of a first position rectum balloon 1 - 11 attached to an urethra catheter 1 - 10 . The rectum balloon has multiple uses and features. The rectum balloon can be used to deliver radiation and simultaneously measure the radiation that is being delivered to the abnormal growth and remove human waste. The rectum balloon has a female or male connection 1 - 8 , that is used to insert any form of a sensor and simultaneously remove human waste by the opening 1 - 12 . The removing of human waste travels through the tube 1 - 3 that is connected to male or female connection 1 - 8 . Furthermore, the rectum balloon has luer lock connection 1 - 7 that is used to inflate the balloon to a predetermined size. The balloon inflation may be used as a locking mechanism for the rectum catheter in the patient or can be used to push internal organs in a certain direction. The rectum balloon 1 - 11 may be attached by a locking mechanism 1 - 9 to the urethra catheter 1 - 10 . The locking mechanism 1 - 9 may be attached by either male or female connection. The locking mechanism 1 - 9 allows for medical personnel to have an easier controlled section to all openings to provide delivery guidance and extraction within a single area. The urethra catheter 1 - 10 has urine extraction whole 1 - 4 that is used to remove fluids in the bladder and is taken out by extraction opening 1 - 5 . Furthermore, a measuring device may be inserted into the opening 1 - 5 while removing the urine. The advantage allows for simultaneously measuring and removing. The urethra catheter balloon 1 - 1 is an inflatable balloon. The balloon inflation can be done by male or female luer lock 1 - 6 . Further drawings will show modification to the both the urethra catheter 1 - 11 and rectum catheter 1 - 10 . [0034] FIG. 2 shows an exemplary sample of a first position rectum balloon 1 - 11 attached to a first position urethra catheter balloon 1 - 10 . Upon further review, the rectum balloon allows for a measuring device 2 - 1 such as MOSFET to be inserted into the center valve. The advantage for inserting the measuring device 2 - 1 will allow medical personnel to measure the dose simultaneously while delivering the radiation to the tumor region. Furthermore, a second measuring device 2 - 2 may be inserted into urethra catheter 1 - 10 . Inflating the balloon 1 - 2 allows for determining the organ region and for a fixing or locking mechanism. The inflating balloon 1 - 2 on the rectum catheter can also be filled with radioactive isotopes that delivers dose while being measured by the measuring device 2 - 1 . This is a big advantage since the dose can be measured and the volume of radio-isotopes can be reduced depending on the inflating size. Next, the second measuring device 2 - 2 can also be inserted to urethra catheter along with a measuring device 2 - 1 in the rectum catheter to allow medical personnel to measure the dose from two different locations at the same time. [0035] FIG. 3 shows an exemplary sample of a first position rectum balloon 1 - 2 and second position rectum balloon 4 - 1 attached to first position urethra catheter balloon 1 - 1 . The rectum catheter 1 - 11 contains two balloons, which allows for the first position rectum balloon 1 - 2 to be used for fixing or locking The second position rectum balloon 4 - 1 can be filled with radioactive isotopes. The second position rectum balloon 4 - 1 can deliver the radiation after the first position balloon has been inflated. Another advantage for a double inflatable balloon can be the first position balloon can be used to move sensitive organs out of the region, which the second position rectum balloon 4 - 1 can deliver the dose. Each balloon has the ability to be filled up with is unique male or female connection. Specifically, the second position balloon 4 - 1 is enlarged by the male/female connection 4 - 2 ; and, the first position rectum balloon 1 - 2 is enlarged by male/female connection 1 - 7 . By allowing each balloon to have its unique connection, the advantage will allow medical personnel to control the size of each balloon independently. [0036] FIG. 4 shows an exemplary sample of a first position rectum balloon 1 - 2 and second position rectum balloon 4 - 1 attached to first position urethra catheter balloon 1 - 1 . The rectum catheter 1 - 11 contains two balloons. The second position rectum balloon 4 - 1 contains radioactive isotopes whiles the first position rectum balloon can contain air or liquid to fill the balloon. The rectum catheter 1 - 11 contains a measuring device 5 - 1 that allows for measuring the dose that is applied to the patient. Next, a measuring device 5 - 2 can also be inserted to urethra catheter along with a measuring device 5 - 1 in the rectum catheter to allow medical personnel to measure the dose from two different locations at the same time. [0037] FIG. 5 shows an exemplary sample of a first position rectum balloon 1 - 2 , a second position radiation balloon 4 - 1 , a third position rectum balloon 7 - 1 attached to first position urethra catheter 1 - 10 . The rectum catheter 1 - 11 has three balloons; however, there can be any number of balloons depending upon the length of the catheter. The rectum catheter 1 - 11 has a second position radiation balloon 4 - 1 that contains radioactive isotopes, while the first position rectum balloon 1 - 2 and the third position rectum balloon 7 - 1 may contain no dose delivery mechanism. The third position rectum balloon 7 - 1 can be inflated by any male/female connector 7 - 3 . When there are many balloons on a single catheter; A-A view 7 - 2 of the catheter is shown below. The A-A view 7 - 2 shows cross-sectional view of the rectum catheter and the unique tubes for inflating or deflating the balloons. By having multiple balloons on a single catheter, you are able to change the shape of each balloon relative to the location in the human body to allow for a proper fixture. [0038] FIG. 6 shows an exemplary sample of a collapsed first position rectum balloon 1 - 2 , a second position radiation balloon 4 - 1 , a third position rectum balloon 7 - 1 attached to the urethra catheter 1 - 10 . The collapsed balloon 8 - 1 allows for minimum expansion of the balloon to keep the human tissue from being moved into any direction. Furthermore, a measuring device 8 - 2 can be inserted into the open section 1 - 3 . The benefit for having multiple balloons allows the control of how much dose can be given. The less inflated the balloon; the closer the radiation source is to the human tissue, but the more inflated the balloon the less the human tissue gets exposed to the radiation source. Next, a measuring device 8 - 3 can also be inserted to urethra catheter along with a measuring device 8 - 2 in the rectum catheter to allow medical personnel to measure the dose from two different locations at the same time. The advantage for having multiple balloons allows medical personnel to have more control. [0039] FIG. 7 is an illustration of how both the urethra catheter and rectum catheter are inserted into the human body. The urethra catheter 10 - 1 is inserted into the penis via urethra. Thereafter, the medical personnel inflates the balloon on the catheter 10 - 2 . This will allow the surround tissue to expand and move out of the way to create space near the prostate 10 - 5 . Furthermore, the rectum catheter 10 - 6 can insert into the rectum of the patient. The rectum catheter has a first position rectum balloon 10 - 3 and a second rectum balloon 10 - 4 . Looking specifically at this illustration, but not limiting it to just second balloon, the second position rectum balloon 10 - 4 contains radioactive isotopes. This can be used to dose the prostate 10 - 5 , and the first position balloon 10 - 3 can be used as a locking or fixing mechanism to the hold the catheter in place. Furthermore, a measuring device can be inserted into both urethra catheter 10 - 1 and a rectum catheter 10 - 6 . [0040] FIG. 8 is an illustration of how both the uretra catheter and rectum catheter are inserted into the human body. The urethra catheter 10 - 1 is inserted all way into the male bladder and inflated with a balloon 11 - 1 . The inflation of the follow will not allow for the urethra catheter to slip out of the bladder. Furthermore, the rectum catheter 10 - 6 has a first position rectum balloon 10 - 3 and a second rectum balloon 10 - 4 . Looking specifically at this illustration, but not limiting it to just second balloon, the second position rectum balloon 10 - 4 contains radioactive isotopes. This can be used to dose the prostate 10 - 5 , and the first position balloon 10 - 3 can be used as a locking or fixing mechanism to the hold the catheter in place. Furthermore, a measuring device can be inserted into both urethra catheter 10 - 1 and a rectum catheter 10 - 6 . [0041] The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope fo the claims where the term “comprising” means “including, but not limited to”. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims. [0042] Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependant claim which follows should be taken as alternatively written in a multiple depend form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly form claim 1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific clim listed in such dependent claim below. [0043] With this description, those skilled in the art may recognize other equivalents to the specific embodiments described herein. Such equivalents are intended to be encompassed by the claims attached hereto.

According to one general aspect, there is A medical device comprising a locking mechanism that is used to connect a plurality of catheters, a multi-balloon inflator that inflates multiple balloons on a single catheter, a extraction point used to remove human fluids from the human body, and a connecting point that allows a syringe or a machine to insert liquid saline solution or radioactive isotopes into said multi-balloon inflator.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is related to U.S. Provisional Application Ser. No. 60/601051, filed on Aug. 13, 2004. BACKGROUND OF THE INVENTION [0002] a. Field of the Invention [0003] This invention relates in general to the field of material handling equipment and in particular to medical material handling apparatus and more particularly to the construction of a tray and cover for primary use in the medical field. [0004] b. Description of the Prior Art [0005] There exists a problem in the prior art in the efficient, sterile and convenient storage and transfer of various medical equipment, drugs, specimens, vials, and other such medical paraphernalia and materials. In the past a simply constructed fiberglass tray having a bottom with four sides extending upward therefrom has been employed for the storage and transfer of the described medical materials. Such simply constructed trays usually have an open top. [0006] One problem associated with the prior art trays is that the fiberglass generates small particles that can contaminate whatever is being stored in the trays. Continual usage and transfer of the trays exacerbate the particle generation and resulting contamination problem. Decontamination of the prior art fiberglass trays by the generally known and used methods in the medical field can cause deterioration of the fiberglass and make it more susceptible to the particle generation problem. For example, both usage and decontamination can cause deterioration of the fiberglass finish coat exposing the glass and resin under the finish coat which can then result in particles of glass and resin. Equally important is that prior art fiberglass trays have been known to fracture. Even a small fracture during usage can generate talc, resin, glass and other particles that can and will contaminate the interior of the prior art trays and the contents within the tray [0007] Additional problems are associated with the prior art trays is that the open top does not prevent the entrance of other contaminates and does not provide for security and/or tamper evidence of the materials being stored in the trays. [0008] Another prior art tray comprises the tray being made from stainless steel. While stainless steel trays do provide for decontamination and are generally superior to fiberglass trays, they are expensive, heavy and can generate metallic particles. Moreover, if stainless steel trays incorporate a provision for stacking one on top of another, they become especially expensive. [0009] Thus, there exists the need for a tray construction that allows for convenient, secure, ready accessibility to the interior thereof, that lessens the problem of contamination, that allows for decontamination without deterioration of the tray itself, and that can be used with a transfer cart, or that can be used for general purposes. These needs have been a long standing problem in the prior art which are overcome by the present invention. SUMMARY OF THE INVENTION [0010] The present invention accomplishes the above-stated objectives as well as others, as may be determined by a fair reading and interpretation of the entire specification herein including the drawings and the claims, which comprises a unique medical storage and transfer tray having a storage member, a removable front side, and a cover member. In a preferred embodiment, the storage member includes a bottom surface, two vertical side members connected to a vertical back member, and a removable front member. The cover member includes a vertical front member connected to a top member with the front member having an inwardly extending bottom edge. In another embodiment, one or more dividing members are provided to divide the space within the inventive tray into one or more discrete compartments. Other unique features are described in the following description of the preferred embodiments. BRIEF DESCRIPTION OF THE DRAWINGS [0011] Various other objects, advantages, and features of the invention will become apparent to those skilled in the art from the following discussion taken in conjunction with the following drawings, in which: [0012] FIG. 1 is an isometric rendering of the storage member comprising the inventive tray; [0013] FIG. 2 is an isometric view of the body of the storage member or tray showing various details of the tray body; [0014] FIG. 3 is an isometric illustration of a removable front member of the tray; [0015] FIG. 4 is a partial view of the fit up of the front member to an “L” shaped groove in a side member; [0016] FIG. 5 is a partial view of the fit up of a tray dividing member to a “U” shaped groove in a side member; [0017] FIG. 6 is an isometric drawing of one embodiment of the cover member; [0018] FIG. 7 is an isometric drawing of another embodiment of the cover member; [0019] FIG. 8 is a partial top view of the lockable feature of the cover and the tray body; and, [0020] FIG. 9 is plan view of the rear of the tray and the attached cover. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0021] As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the invention. [0022] Reference is now made to the drawings, wherein like characteristics and features of the present invention shown in the various figures are designated by the same reference numerals. [0023] Reference is now made to FIGS. 1 and 2 which comprise an isometric view of the inventive tray apparatus 10 comprising the tray body 11 having a cover 34 attached thereto, and an isometric view of the tray body 11 , respectively. The tray body 11 includes a bottom 12 , one side member 13 , an opposite side member 14 , and a back member 15 ; the back and side members being integrally attached to the bottom 12 along a horizontal edge thereof such that an open three sided box like structure is formed. The actual dimensions of the box-like structure are of course not critical to the invention. However, for purposes of explanation and as an example, the body 11 may be approximately 18 inches in depth, approximately 12 inches in width, and approximately five inches high. In a preferred embodiment, the box-like structure or body 11 , is formed from clear or transparent, rigid plastic that is injection molded in one piece. The transparency allows any objects stored in the inventive apparatus to be viewed without the necessity of having to open the tray 10 . In order to assist in automatic or machine assisted loading of a plurality of vials, ampoules or other such objects, it is preferable that the top surface of the bottom member 12 be provided with a friction reducing medium or a physical surface treatment such an embossment having rounded edges that allow vials or ampoules to easily slide there along when for example the vials or ampoules are mass loaded into a tray by a pushing technique. [0024] It is preferred that the plastic material from which the body 11 of the tray 10 is made comprises injectable plastic, for example a polycarbonate, that is not filled with a material such as fiber glass or other particle generating filler. Non-filled injectable plastic completely eliminates the prior art problem of talc, glass, resin and metallic particles being generated by use, handling, transfer and decontamination of the tray. Additionally, injection molding allows for substantially parallel inside and outside surfaces of the walls of sides 13 , 14 and back member 15 of the tray 10 and substantial perpendicularity with the bottom member 12 . Such parallelism and perpendicularity further allows for close toleranced and convenient attachment of a front 28 A and intermediate or dividing 28 B panels and cover 34 to the tray body 11 that is important for safe storage and proper insertion and arranging of small diameter vials and ampoules within the tray 10 . The plastic material can also be specially adapted to accommodate different needs, e g. general storage trays, autocavable trays, and trays exposed to sub freezing temperatures. Suitable plastics include but are not limited to polyphenylsulfone and polycarbonate S X, the latter being available from the General Electric Company. [0025] Plastic trays are preferred because of further advantages associated with plastic, i.e. it allows for color coding, allows for venting perforations that do not generate particles, and any plastic particles that are generated do not comprise medical contamination. [0026] The tops of the side members 13 , 14 and the back member 15 are provided with a ledge 16 that extends around and internal to the side and back members and is located an appropriate distance below the top edges 17 of a rim 20 . (See FIG. 2 ) The ledge 16 stops a small distance from the front edges 25 of sides 13 and 14 so as to form a small lip or protruding member 21 that in combination with the rim 20 of the back member provides front to rear containment of another tray 10 when stacked on the ledge 16 of a first tray 10 . Side to side containment being obtained by inside edges of the rim 20 of sides 13 and 14 directly above the ledge 16 . The bottom of each tray 10 is configured to fit within the ledge 16 of another tray 10 such as by providing another rim or footer that fits within the rim 20 . The ledge 16 further provides a surface for fitting a cover member to the tray body 11 so as to completely enclose the tray 10 . [0027] The top edges 17 of the rim 20 of the side members 13 , 14 can be provided with elongated members 18 that extend outwardly in the direction of top edge 17 for an appropriate distance and serve as handles to allow lifting or otherwise moving of the tray 10 . The back member 15 is likewise provided with an extending handle member 19 which is further provided with a slot or groove 22 at the approximate center of handle 19 , the bottom surface of the groove 22 being positioned to lie in the plane of the ledge 16 . An opening 23 is provided through the bottom surface of groove 22 within the extending portion of handle 19 . [0028] Each side 13 and 14 is provided with a plurality of pairs of vertical grooves 24 (relative to the bottom member) spaced along the inner surface of each side 13 and 14 . Each groove 24 of each pair of grooves being located opposite each other such that the distance from the front edge 24 of sides 13 and 14 of each pair of grooves is the same. One or more of the grooves 24 can have an “L” shaped cross sectional configuration 24 A. Others can have “U” shaped cross sectional configuration 24 B. Preferably, the first one or two pairs of grooves 24 A, back from the front edges 25 of sides 13 and 14 , have the “L” configuration. The different configurations of grooves 24 A and 24 B are shown in FIG. 2 . [0029] The grooves 24 A and 24 B do not extend to the bottom member 12 , but rather stop a short distance above the bottom member 12 where the bottom of the grooves intersect with the inside surface of sides 13 and 14 . The purpose of the non continual length of grooves 24 A and 24 B is to provide a flush surface directly below the grooves that comprises the interior surface of sides 13 and 14 . A flush surface is important when small vials or ampoules are being loaded into the tray 10 . In this way, the small vials or ampoules do not hang up within the grooves or are affected in their movement by the edges of the grooves. [0030] FIG. 2 illustrates the outer surface of side 14 and applies equally to the outer side of side 13 . The wall of sides 13 and 14 are relatively thin and can approximately equal the width of ledge 16 and such that the rim 20 extends outward from the walls. A plurality of ribs 32 is provided at the location of the grooves 24 on the outside of sides 13 and 14 in order to provide stiffness to sides 13 and 14 and to maintain the relative thinness of the walls of sides 13 and 14 . In this manner, the tray body 11 is able to be made stiff but relatively light in weight. Moreover, the ribs 32 allow the depth of the grooves 24 to exceed the thickness of the walls of sides 13 and 14 . Additional reinforcing ribs can be provided at the corners of tray body 11 . [0031] FIG. 3 shows a front member or panel 28 A that is preferably fitted to the grooves 24 A in sides 13 and 14 having the “L” shaped configuration. Front member 28 A is a separate part from tray body 11 . Front member 28 A is also clear or translucent and can be injection molded from a rigid type of plastic having features as described above. Front member 28 A essentially comprises a planer member having a pair of “U” shaped slots or grooves 29 in the front or back surface thereof and extend in a vertical direction and located at a small distance inward from the ends 31 . Front member 28 A is intended to be removably attached to the tray body 11 such that it forms the front side of the tray 10 . The bottom portion 30 of the ends 31 is cut away so as to effectively eliminate the groove 29 at the cut away portion 30 . Thus, grooves 29 do not extend to the bottom edge of front member 28 A but stop at the beginning of the cut away portion 30 . The combination of the non-grooved portion 30 and the non-continuous length of grooves 24 A allow the front member 28 A to be inserted in grooves 24 A and yet allow the bottom edge of front member 28 A to come in contact with and rest on the upper surface of tray bottom 12 . In other words the unique configuration of grooves 24 A and 29 allow the front panel 28 A to be inserted in grooves 24 A for the full height of the sides 13 and 14 and for the full height of front panel 28 A such that the top edge of front panel 28 A substantially lies in the plane of ledge 16 and the bottom edge of panel 28 A rests on the upper surface of bottom member 12 . [0032] FIG. 4 illustrates a top view of the front panel 28 A fitted to an “L” shaped groove 24 A in a side member 13 or 14 . Although FIG. 4 illustrates such attachment as applied to one side 13 or 14 of tray body 11 , it is to be understood that the same attachment applies to the opposite side. In installing the front member 28 A, the “U” shaped grooves 29 of the front member 28 A are aligned with the “L” shaped grooves 24 A in the side members 13 and 14 and inserted in a downward direction until the bottom edge meets with the top surface of bottom member 12 . The interlocking fit up of the front member 28 A with the side members 13 and 14 , shown in FIG. 4 , results from the configurations 24 A and 29 of the respective grooves, and provides further structural rigidity to the tray 10 . While some clearance space is necessary between the interlocking grooves 24 A and 29 in order to assemble the two members, modern injection molding can allow for tight or close tolerances that provide for very small clearances such that upon assembly, a relatively rigid structure of the tray 10 is effectuated. Additional rigidity can be obtained by utilizing the same interlocking fit up by fitting a second removable panel 28 A in a second pair of “L” shaped grooves 24 A located an appropriate distance toward the back side of body 11 and spaced from the first panel 28 A. [0033] One or more front to rear space dividing panels 28 B can be incorporated in the tray 10 . In a simpler embodiment, as partially shown in FIG. 5 , the dividing panels 28 B do not have the interlocking fit up as the front one or two panels 28 A. The dividing panels 28 B can simply comprise a planer member without any grooves that fit within the “U” shaped grooves 24 B in side members 13 and 14 . The “U” shaped grooves 24 B are also non-continuous in length as with the grooves 24 A. The dividing panels 28 B do however incorporate the cut away portion 30 in the same manner as per the front panel 28 A. Thus. as with the front panels 28 A, the top edge of the dividing panels 28 B lies in the plane of the ledge 16 when the dividing panels 28 B are fully inserted in the tray body 11 , and the bottom edge of the panel 28 B rests on the upper surface of tray bottom 12 . [0034] The front to rear space between two interlocking panels 28 A, or an interlocking panel 28 A and a non-interlocking panel 28 B, can be further divided into side to side spaces by providing full length grooves 24 C in the front and or back surfaces of the panels 28 A and or 28 B. and inserting a plain panel 28 C in the grooves 24 C. The cross sectional configuration of grooves 24 C can either be the “L” or the “U” shaped configuration. Thus, the side to side dividing panels 28 C and the grooves 24 C do not incorporate the cut away portion 30 . Rather the side edges of panels 28 C and their respective grooves 24 C extend the full height of the panels. [0035] The divided interior spaces in tray 10 are of course intended be used for storage and to allow separation of different types of vials and other medical paraphernalia. This feature allows for a plurality of separate compartments within a single tray 10 . For example, the divided spaces can be sized to fit vial receiving stands that contain vials in a particular order and location. Additional uses for the inventive tray 10 and the divided spaces can be readily envisioned. [0036] Front panels or members 28 A and or dividing panels 28 b can be provided with one or more openings through the face of the panels. This feature is shown in phantom in FIG. 3 . The openings which can be square, rectangular or round, can allow for access into the tray 10 or its divided compartments when the front panel 28 A or dividing panels 28 B are inserted in place in to tray body 11 . [0037] A cover 34 for the inventive tray 10 is shown in FIG. 6 . In one embodiment, the cover 34 A is preferably made from stainless steel sheet metal formed to include a planer top member 35 and a planar front member 36 The cover 34 A is appropriately dimensioned such that the top member 35 rests on the ledge 16 (provided at the top of the sides 13 and 14 and back members 15 ) and within the rim 20 , thereby covering the open top of tray body 11 while the front member 36 fits over the open front of tray body 11 . In this manner the inventive tray 10 is completely encased and any medical paraphernalia contained therein is free from possible contamination. In a further embodiment 34 B of a stainless steel cover, another planer member 37 extends a relatively short distance from the bottom of the front member 37 back in the direction of and parallel to top member 35 . The purpose of the backwardly extending planer member 37 is to fit under the front edge of the bottom 12 of tray body 11 so as to further secure the cover to the tray body 11 . [0038] The width of the top member 35 of cover 34 A and 34 B is slightly smaller that the distance between the outside of ledges 16 and inside the rim 20 , so as to fit therebetween and rest thereon. In attaching the cover 34 A or 34 B to the tray body 11 , the top planer member 35 is inserted in slots 32 provided below the small lips 21 , which lips serve to comprise non-ledged portions of the front and top of the sides 13 and 14 of the tray body 11 , and then pushed rearward until contact is made with the rim 20 of the back member 15 . Both the slots 32 and the backwardly extending planer member 37 , serve to prevent the covers 34 A and 34 B from inadvertently being lifted off the tray body 11 . The cut outs 38 in the front of cover 34 A and 34 B provide clearance for the small lips 21 . [0039] Yet another embodiment 34 C of the stainless steel cover 34 comprises a cover that is configured the same as a plastic cover 39 and attached to tray body 11 in the same manner as described below. [0040] In another embodiment, a cover 34 D is made from a rigid transparent or translucent plastic as described above having a top planar member 40 that is generally configured the same as top member 35 of the stainless steel embodiments so as to provide a proper fit up with the tray body 11 . See FIG. 7 . In this embodiment 34 D, the front face 41 is provided with the “U” shaped grooves 29 and the cut away portions 30 as with the plastic front panel 28 A. Thus, the grooves 29 of the plastic cover 34 D fit within the “L” shaped grooves 24 A in the tray body 11 and in the same manner as the front plate member 28 A. In attaching the plastic cover 34 D to the tray body 11 , the front face member 39 is inserted in the “L” shaped grooves 24 A in each side member 13 and 14 and then lowered until the top member 40 rests on the ledges 16 . With the plastic cover embodiment, a front plate 28 A is not used. However, if it is desired to utilize a front plate member 28 A in addition to the front plate 41 of the plastic cover 34 D, a second pair of “L” shaped grooves 24 A can be provided in side members 13 and 14 a small distance from the first pair of “L” shaped grooves 24 A, back toward the back member 15 . The second pair of “L” shaped grooves 24 A is then used to fit the front plate member 28 A. [0041] With all embodiments of the cover 34 , an extending tab 43 having a through opening 44 at the rearmost location of cover 34 or 38 is configured to fit with the slot or groove 22 provided in the back handle 19 of back member 15 when the cover 34 is placed on the tray body 11 . At this time, the through opening 44 in tab 43 aligns with the through opening 23 in the back handle 19 . In this manner when the cover 34 is placed on tray body 11 , a lock can be inserted in the openings 23 and 44 to prevent unauthorized entry into the covered tray 10 . Moreover, with the present invention and because of the location of the lockable feature, the lock does not interfere with stacking feature of the inventive trays 10 or otherwise interfere with the containment features of the tray 10 . [0042] In a preferred embodiment the bottom external surface of bottom member 12 of tray body is provided with footer or rim that extends around the bottom member 12 and is indented a small distance so as to rest on and fit within the ledge 16 of another tray 10 . In this manner, one tray 10 can be stacked on another tray 10 with the footer of the upper tray 10 resting on and fitting within the ledges 16 of the lower tray 10 and, as explained above provides for front to rear and side to side containment of stacked trays 10 . In order to remove an intermediate tray 10 from a stack of trays 10 , it is a simple matter to slightly lift the upper tray or trays 10 to allow the intermediate tray 10 to clear the footer from the ledge 16 and allow the intermediate tray 10 to be removed from the stack. [0043] In accordance with the above, an improved tray is disclosed that can be used as a standard in the fields of medicine, biotech, pharmaceuticals and others where the advantages of different types of plastic can be utilized to their fullest extent. Indeed, the versatility of the inventive tray fulfills the storage and handling needs of many fields including those requiring sterile conditions. [0044] While the invention has been described, disclosed, illustrated and shown in certain terms or certain embodiments or modifications which it has assumed in practice, the scope of the invention is not intended to be nor should it be deemed to be limited thereby and such other modifications or embodiments as may be suggested by the teachings herein are particularly reserved especially as they fall within the breadth and scope of the description of the invention and the drawings here appended.

Medical tray and cover apparatus includes a tray body having an open top and an open front; the cover is removable and covers the tray top and front. The tray body includes a plurality of oppositely disposed grooves that provide for the insertion of closure and divider panels. The tray grooves are configured to allow the tray to be loaded with ampoules or vials without being snagged by the grooves. The trays are transparent so that its contents are visible without removing the cover. The trays are stackable with the cover in place. The trays are lockable such that the ability to stack the trays is not interfered with. The tray and cover eliminate particle generation from use and wear that can contaminate the contents of the tray. The tray and cover are capable of being autoclaved.

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims priority to U.S. Provisional Application Ser. No. 61/358,704, filed Jun. 25, 2010, the entire contents of each of which are incorporated by reference herein. BACKGROUND [0002] 1. Technical Field [0003] The present application relates to the field of biomarkers, and more particularly to biomarkers for lung cancer. [0004] 2. Description of the Art [0005] Lung cancer is the leading cause of cancer death in both men and women in the United States with an expected 5-year survival rate of 16%. Since conventional therapy provides only limited success, translational research designed to improve outcomes with this disease is critical. The goal is to develop more effective chemopreventive and chemotherapeutic agents for the prevention and treatment of lung cancer. [0006] The importance of prostaglandins (PGs) in tumor progression has been realized for several years. Harris R E. Cyclooxygenase-2 (cox-2) blockade in the chemoprevention of cancers of the colon, breast, prostate, and lung. Inflammopharmacology 2009; 17:55-67; Wang D, Dubois R N. Prostaglandins and cancer. Gut 2006; 55:115-22. Cyclooxygenase-2 (COX-2) derived PGE 2 can promote tumor growth by binding its receptors and activating signaling pathways which control cell proliferation, migration, apoptosis, and angiogenesis. Wang D, Dubois R N, “Prostaglandins and cancer”, Gut 55:115-122 (2006); Murata T, Lin M I, Aritake K, Matsumoto S, Narumiya S, Ozaki H, Urade Y, Hori M, Sessa W C, “Role of prostaglandin D2 receptor DP as a suppressor of tumor hyperpermeability and angiogenesis in vivo”, Proc Natl Acad Sci USA. 2008 Dec. 16; 105(50):20009-14. The predominance of COX activity in cell lines derived from human non-small cell carcinomas of the lung suggest that prostanoid biosynthesis may be characteristic of tumor cells comprising certain histological subclasses of human non-small cell carcinomas of the lung, particularly adenocarcinoma, bronchioloalveolar cell carcinoma, large cell undifferentiated carcinoma, and possibly adenosquamous carcinoma. Hubbard W C, Alley M C, Gray G N, Green K C, McLemore T L, Boyd M R, “Evidence for prostanoid biosynthesis as a biochemical feature of certain subclasses of non-small cell carcinomas of the lung as determined in established cell lines derived from human lung tumors”, Cancer Res 49:826-832 (1989)[1]. Both epidemiological studies and clinical trials indicate that prolonged use of non-steroidal anti-inflammatory drugs (NSAIDs) are associated with a decreased incidence of certain malignancies, including lung cancer. Wall R J, Shyr Y, Smalley W, “Nonsteroidal anti-inflammatory drugs and lung cancer risk: a population-based case control study”, J Thorac Oncol 2:109-114 (2007). The initial excitement of using COX-2 inhibitors as practical chemopreventives was dampened, however, by the undesirable cardiovascular side effects observed after prolonged use. Rahme E, Nedjar H, “Risks and benefits of COX-2 inhibitors vs. non-selective NSAIDs: does their cardiovascular risk exceed their gastrointestinal benefit? A retrospective cohort study”, Rheumatology (Oxford) 46:435-438 (2007); Solomon S D, McMurray J J, Pfeffer M A, Wittes J, Fowler R, Finn P, Anderson W F, Zauber A, Hawk E, Bertagnolli M, “Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention”, N Engl J Med 352:1071-1080 (2005). [0007] See also, Sargent L M, Ensell M X, Ostvold A C, Baldwin K T, Kashon M L, Lowry D T, Senft J R, Jefferson A M, Johnson R C, Li Z, Tyson F L, Reynolds S H, “Chromosomal changes in high- and low-invasive mouse lung adenocarcinoma cell strains derived from early passage mouse lung adenocarcinoma cell strains”, Toxicol Appl Pharmacol. 15:233(1):81-91 (2008); Sargent L M, Senft J R, Lowry D T, Jefferson A M, Tyson F L, Malkinson A M, Coleman A E, Reynolds S H, “Specific chromosomal aberrations in mouse lung adenocarcinoma cell lines detected by spectral karyotyping: a comparison with human lung adenocarcinoma”, Cancer Res 62:1152-1157 (2002). [0008] L-PGDS is unique member of the lipocalin superfamily of proteins acting as both a lipophilic ligand-binding protein facilitating the transport of retinoids, thyroids and bile pigments, and possessing enzymatic activity catalyzing the isomerization of PG H 2 into PGD 2 [2]. Tanaka T, Urade Y, Kimura H, Eguchi N, Nishikawa A, Hayaishi O, “Lipocalin-type prostaglandin D synthase (beta-trace) is a newly recognized type of retinoid transporter”, J Biol Chem 272:15789-15795 (1997). Originally purified from the central nervous system, L-PGDS comprises about four percent of the total cerebrospinal fluid protein, and has typically been associated with the regulation of the sleep-wake cycle and sensitivity to tactile pain. Urade Y, Hayaishi O, “Prostaglandin D synthase: structure and function. Vitam Horm”, 58:89-120 (2000). Several recent findings also demonstrate that L-PGDS has important vascular functions. Eguchi Y, Eguchi N, Oda H, Seiki K, Kijima Y, Matsu-ura Y, Urade Y, Hayaishi O, “Expression of lipocalin-type prostaglandin D synthase (beta-trace) in human heart and its accumulation in the coronary circulation of angina patients”, Proc Natl Acad Sci USA 94:14689-14694 (1997); Inoue T, Takayanagi K, Morooka S, Uehara Y, Oda H, Seiki K, Nakajima H, Urade Y, “Serum prostaglandin D synthase level after coronary angioplasty may predict occurrence of restenosis”, Thromb Haemost 85:165-170 (2001); Hirawa N, Uehara Y, Ikeda T, Gomi T, Hamano K, Totsuka Y, Yamakado M, Takagi M, Eguchi N, Oda H, Seiki K, Nakajima H, Urade Y, “Urinary prostaglandin D synthase (beta-trace) excretion increases in the early stage of diabetes mellitus”, Nephron 87:321-327 (2001); Miwa Y, Takiuchi S, Kamide K, Yoshii M, Horio T, Tanaka C, Banno M, Miyata T, Sasaguri T, Kawano Y, “Identification of gene polymorphism in lipocalin-type prostaglandin D synthase and its association with carotid atherosclerosis in Japanese hypertensive patients”, Biochem Biophys Res Commun 322:428-433 (2004); Hirawa N, Uehara Y, Yamakado M, Toya Y, Gomi T, Ikeda T, Eguchi Y, Takagi M, Oda H, Seiki K, Urade Y, Umemura S, “Lipocalin-type prostaglandin d synthase in essential hypertension”, Hypertension 39:449-454 (2002); as well as implications to cancer. Eichele K, Ramer R, Hinz B. Decisive role of cyclooxygenase-2 and lipocalin-type prostaglandin D synthase in chemotherapeutics-induced apoptosis of human cervical carcinoma cells. Oncogene 2008; 27:3032-44; Kim J, Yang P, Suraokar M, Sabichi A L, Llansa N D, Mendoza G, et al. Suppression of prostate tumor cell growth by stromal cell prostaglandinDsynthase-derived products. Cancer Res 2005; 65:6189-98; Sauter E R, Ehya H, Babb J, Diamandis E, Daly M, Klein-Szanto A, et al. Biological markers of risk in nipple aspirate fluid are associated with residual cancer and tumour size. Br J Cancer 1999; 81:1222-7; Su B, Guan M, Zhao R, Lu Y. Expression of prostaglandin D synthase in ovarian cancer. Clin Chem Lab Med 2001; 39:1198-203; Borchert G H, Melegos D N, Yu H, Giai M, Roagna R, Ponzone R, et al. Quantification of pepsinogen C and prostaglandin D synthase in breast cyst fluid and their potential utility for cyst type classification. Clin Biochem 1999; 32:39-44; Rogers M S, Rohan R M, Birsner A E, D'Amato R J. Genetic loci that control vascular endothelial growth factor-induced angiogenesis. FASEB J 2003; Takeda K, Yokoyama S, Aburatani H, Masuda T, Han F, Yoshizawa M, et al. Lipocalin-type prostaglandin D synthase as a melanocyte marker regulated by MITF. Biochem Biophys Res Commun 2006; 339:1098-106; Malki S, Bibeau F, Notarnicola C, Rogues S, Berta P, Poulat F, et al. Expression and biological role of the prostaglandin D synthase/SOX9 pathway in human ovarian cancer cells. Cancer Lett 2007; 255:182-93; Sasaki H, Nishikata I, Shiraga T, Akamatsu E, Fukami T, Hidaka T, et al. Overexpression of a cell adhesion molecule, TSLC1, as a possible molecular marker for acute-type adult T-cell leukemia. Blood 2005; 105:1204-13; Fujimori K, Kadoyama K, Urade Y. Protein kinase C activates human lipocalintype prostaglandin D synthase gene expression through de-repression of notch-HES signaling and enhancement of AP-2 beta function in brain-derived TE671 cells. J Biol Chem 2005; 280:18452-61; Garcia-Fernandez L F, Iniguez M A, Eguchi N, Fresno M, Urade Y, Munoz A. Dexamethasone induces lipocalin-type prostaglandin D synthase gene expression in mouse neuronal cells. J Neurochem 2000; 75:460-70; Yamashima T, Sakuda K, Tohma Y, Yamashita J, Oda H, Irikura D, et al. Prostaglandin D synthase (beta-trace) in human arachnoid and meningioma cells: roles as a cell marker or in cerebrospinal fluid absorption, tumorigenesis, and calcification process. J Neurosci 1997; 17:2376-82; Kawashima M, Suzuki S O, Yamashima T, Fukui M, Iwaki T. Prostaglandin D synthase (beta-trace) in meningeal hemangiopericytoma. Mod Pathol 2001; 14:197-201; Wei T, Geiser A G, Qian H R, Su C, Helvering L M, Kulkarini N H, et al. DNAmicroarray data integration by ortholog gene analysis reveals potential molecular mechanisms of estrogen-dependent growth of human uterine fibroids. BMC Womens Health 2007; 7:5; Mannino D M, Braman S. The epidemiology and economics of chronic obstructive pulmonary disease. Proc Am Thorac Soc 2007; 4:502-6. [0009] For example: L-PGDS and PGD 2 metabolites produced by normal prostate stromal cells inhibited tumor cell growth through a peroxisome proliferator-activated receptor gamma (PPARγ)-dependent mechanism potentially contributing to the indolence and long latency period of this disease. Kim J, Yang P, Suraokar M, Sabichi A L, Llansa N D, Mendoza G, Subbarayan V, Logothetis C J, Newman R A, Lippman S M, Menter D G, “Suppression of prostate tumor cell growth by stromal cell prostaglandin D synthase-derived products”, Cancer Res 65:6189-6198 (2005). L-PGDS in nipple aspirate fluid is used to predict residual ductal carcinoma in situ (DCIS) or invasive cancer after needle or excisional biopsy of the breast. Sauter E R, Ehya H, Babb J, Diamandis E, Daly M, Klein-Szanto A, Sigurdson E, Hoffman J, Malick J, Engstrom P F, “Biological markers of risk in nipple aspirate fluid are associated with residual cancer and tumour size”, Br J Cancer 81:1222-1227 (1999); Nakamura M, Yamaguchi S, Motoyoshi K, Negishi M, Saito-Taki T, Matsumoto K, Hayashi I, Majima M, Kitasato H, “Anti-tumor effects of prostaglandin D2 and its metabolites, 15-deoxy-Δ12, 14-PGD2, by peroxisome proliferator-activated receptor (PPAR) γ-dependent and -independent pathways.” Inflammation and Regeneration 31:2-189-195 (2011). Expression of L-PGDS mRNA exists in ovarian cancer, and is related to the cancer type. Su B, Guan M, Zhao R, Lu Y, “Expression of prostaglandin D synthase in ovarian cancer”, Clin Chem Lab Med 39:1198-1203 (2001). Quantification of L-PGDS in breast cyst fluid may be useful in the subclassification of cyst type in patients with gross cystic disease. Borchert G H, Melegos D N, Yu H, Giai M, Roagna R, Ponzone R, Sgro L, Diamandis E P, “Quantification of pepsinogen C and prostaglandin D synthase in breast cyst fluid and their potential utility for cyst type classification”, Clin Biochem 32:39-44 (1999); L-PGDS has been identified as a genetic loci controlling VEGF-induced angiogenesis, Rogers M S, Rohan R M, Birsner A E, D'Amato R J, “Genetic loci that control vascular endothelial growth factor-induced angiogenesis”, Faseb J (2003). L-PGDS mRNA is present in melanocytes but undetectable in human melanoma cell lines. Takeda K, Yokoyama S, Aburatani H, Masuda T, Han F, Yoshizawa M, Yamaki N, Yamamoto H, Eguchi N, Urade Y, Shibahara S, “Lipocalin-type prostaglandin D synthase as a melanocyte marker regulated by MITF”, Biochem Biophys Res Commun 339:1098-1106 (2006). L-PGDS may be a possible diagnostic marker for ovarian carcinomas. Malki S, Bibeau F, Notarnicola C, Rogues S, Berta P, Poulat F, Boizet-Bonhoure B, “Expression and biological role of the prostaglandin D synthase/SOX9 pathway in human ovarian cancer cells”, Cancer Lett 255:182-193 (2007). It is also a possible diagnostic marker for adult T-cell leukemia. Sasaki H, Nishikata I, Shiraga T, Akamatsu E, Fukami T, Hidaka T, Kubuki Y, Okayama A, Hamada K, Okabe H, Murakami Y, Tsubouchi H, Morishita K, “Overexpression of a cell adhesion molecule, TSLC1, as a possible molecular marker for acute-type adult T-cell leukemia”, Blood 105:1204-1213 (2005). A novel transcriptional regulatory mechanism is responsible for the high level expression of the human L-PGDS gene in TE671 (medulloblastoma of cerebellum) cells. Fujimori K, Kadoyama K, Urade Y, “Protein kinase C activates human lipocalin-type prostaglandin D synthase gene expression through de-repression of notch-HES signaling and enhancement of AP-2 beta function in brain-derived TE671 cells”, J Biol Chem 280:18452-18461 (2005). L-PGDS is differentially expressed in melanoma patients after vaccination with a tumor-specific antigen. Mannino D M, Braman S, “The epidemiology and economics of chronic obstructive pulmonary disease”, Proc Am Thorac Soc 4:502-506 (2007). The tumor promoter 12-O-tetradecanoyl-phorbol 13-acetate (TPA), which induces the synthesis of PGs in many tissues, inhibits L-PGDS expression. Garcia-Fernandez L F, Iniguez M A, Eguchi N, Fresno M, Urade Y, Munoz A, “Dexamethasone induces lipocalin-type prostaglandin D synthase gene expression in mouse neuronal cells”, J Neurochem 75:460-470 (2000). Functional differences in various types of meningeal cells are attributable to differences in L-PGDS expression with meningioma cells showing intense L-PGDS immunoreactivity in the perinuclear region. Yamashima T, Sakuda K, Tohma Y, Yamashita J, Oda H, Irikura D, Eguchi N, Beuckmann C T, Kanaoka Y, Urade Y, Hayaishi O, “Prostaglandin D synthase (beta-trace) in human arachnoid and meningioma cells: roles as a cell marker or in cerebrospinal fluid absorption, tumorigenesis, and calcification process”, J Neurosci 17:2376-2382 (1997); Kawashima M, Suzuki S O, Yamashima T, Fukui M, Iwaki T, “Prostaglandin D synthase (beta-trace) in meningeal hemangiopericytoma”, Mod Pathol 14:197-201 (2001); L-PGDS expression is related to estrogen-dependent cell survival and leiomyoma tumor growth. Wei T, Geiser A G, Qian H R, Su C, Helvering L M, Kulkarini N H, Shou J, N'Cho M, Bryant H U, Onyia J E, “DNA microarray data integration by ortholog gene analysis reveals potential molecular mechanisms of estrogen-dependent growth of human uterine fibroids”, BMC Womens Health 7:5 (2007). L-PGDS gene amplification represents a novel method of calibration for erythroblastic leukemia viral oncogene homolog 2 in breast cancer aiding prognosis. Mannino D M, Braman S, “The epidemiology and economics of chronic obstructive pulmonary disease”, Proc Am Thorac Soc 4:502-506 (2007); L-PGDS-mediated effects on cell proliferation, apoptosis and migration in various cell lines suggest a possible role in cancer progression. Ragolia L, Palaia T, Paric E, Maesaka J K. Prostaglandin D2 synthase inhibits the exaggerated growth phenotype of spontaneously hypertensive rat vascular smooth muscle cells. J Biol Chem 2003; 278:22175-81; Ragolia L, Palaia T, Koutrouby T B, Maesaka J K. Inhibition of cell cycle progression and migration of vascular smooth muscle cells by prostaglandin D2 synthase: resistance in diabetic Goto-Kakizaki rats. Am J Physiol Cell Physiol 2004; 287:C1273-81; Maesaka J K, Palaia T, Frese L, Fishbane S, Ragolia L. Prostaglandin D(2) synthase induces apoptosis in pig kidney LLC-PK1 cells. Kidney Int 2001; 60:1692-8. [0010] The biochemical relationships with its precursor, arachadonic acid, and metabolits PGF 2α , PGE 2 , PGD 2 , and more distantly PGD 2 , are shown in FIG. 8 . For example, vascular smooth muscle cells isolated from diabetic rats as well as spontaneously hypertensive rats commonly display hyper-proliferative phenotypes. L-PGDS suppresses the exaggerated proliferation of cells isolated from hypertensive animals. Ragolia L, Palaia T, Paric E, Maesaka J K, “Prostaglandin D2 synthase inhibits the exaggerated growth phenotype of spontaneously hypertensive rat vascular smooth muscle cells”, J Biol Chem 278:22175-22181 (2003). It also suppresses excess proliferation of cells from diabetic animals. Ragolia L, Palaia T, Koutrouby T B, Maesaka J K, “Inhibition of cell cycle progression and migration of vascular smooth muscle cells by prostaglandin D2 synthase: resistance in diabetic Goto-Kakizaki rats”, Am J Physiol Cell Physiol 287:C1273-1281 (2004). Two complementary mechanisms are involed: i) the stimulation of apoptosis; and ii) the inhibition of cell proliferation by stalling cell cycle progression. L-PGDS-induced apoptosis was confirmed by the TUNEL assay, annexin V staining, electron microscopy, and caspase3 activity, and was both time and dose dependent. Data suggests that glycosylation alters the apoptotic potency of L-PGDS. Maesaka J K, Palaia T, Frese L, Fishbane S, Ragolia L, “Prostaglandin D(2) synthase induces apoptosis in pig kidney LLC-PK1 cells”, Kidney Int 60:1692-1698 (2001). Concomitant with its effect on apoptosis, L-PGDS was shown to inhibit excess cell proliferation by stalling cell cycle progression. Immunoblot analysis of cell cycle proteins clearly demonstrated the regulatory role of L-PGDS in cell cycle progression and the resistance observed in diabetic cells. Ragolia L, Palaia T, Koutrouby T B, Maesaka J K, “Inhibition of cell cycle progression and migration of vascular smooth muscle cells by prostaglandin D2 synthase: resistance in diabetic Goto-Kakizaki rats”, Am J Physiol Cell Physiol 287:C1273-1281 (2004). In the case of cyclin D1 and cdk2, L-PGDS was able to inhibit serum-induced protein expression in wildtype cells, but failed to do so in diabetic cells. There were no L-PGDS effects on either cyclin D3 or p27 Kip1 protein expression, although there were alterations of their gene expressions in wildtype cells. In addition, serum-induced protein expression of p21 Cip1 was inhibited by L-PGDS in wildtype cells and not diabetic cells, implicating this cyclin-dependent kinase inhibitor. Finally, L-PGDS inhibits PDGF-induced VSMC migration in control VSMCs but not diabetic cells. Ragolia L, Palaia T, Koutrouby T B, Maesaka J K, “Inhibition of cell cycle progression and migration of vascular smooth muscle cells by prostaglandin D2 synthase: resistance in diabetic Goto-Kakizaki rats”, Am J Physiol Cell Physiol 287:C1273-1281 (2004). [0011] PKC is a family of serine/threonine kinases traditionally associated with the regulation of cell proliferation and differentiation. Nishizuka Y, “The molecular heterogeneity of protein kinase C and its implications for cellular regulation”, Nature 334:661-665 (1988). Certain isoforms are linked to the induction of apoptosis. Powell C T, Brittis N J, Stec D, Hug H, Heston W D, Fair W R, “Persistent membrane translocation of protein kinase C alpha during 12-0-tetradecanoylphorbol-13-acetate-induced apoptosis of LNCaP human prostate cancer cells”, Cell Growth Differ 7:419-428 (1996); Day M L, Zhao X, Wu S, Swanson P E, Humphrey P A, “Phorbol ester-induced apoptosis is accompanied by NGFI-A and c-fos activation in androgen-sensitive prostate cancer cells”, Cell Growth Differ 5:735-741 (1994). PKCs have been linked to carcinogenesis since PKC activators can act as tumor promoters. Furthermore, functional studies have suggested that PKCs play a role in the carcinogenesis and maintenance of malignant phenotype. PMA-induced apoptosis is mediated by L-PGDS phosphorylation and is accompanied by the inhibition of the phosphatidylinositol 3-kinase (PI3-K) and protein kinase B (Akt) pathways. Ragolia L, Palaia T, Paric E, Maesaka J K, “Elevated L-PGDS activity contributes to PMA-induced apoptosis concomitant with downregulation of PI3-K”, Am J Physiol Cell Physiol 284:C119-126 (2003). Akt, GSK-3β, and Rb phosphorylations are inhibited by L-PGDS. In addition, sustained MAPK activity, via a reduction of MKP-1, accompanies the increased insulin-stimulated cell proliferation observed in hypertensive cells. Begum N, Ragolia L, Rienzie J, McCarthy M, Duddy N, “Regulation of mitogen-activated protein kinase phosphatase-1 induction by insulin in vascular smooth muscle cells. Evaluation of the role of the nitric oxide signaling pathway and potential defects in hypertension”, J Biol Chem 273:25164-25170 (1998), Basal MKP-2 expression is elevated in L-PGDS KO's, and the addition of exogenous L-PGDS abolishes MKP-2 expression. Ragolia L, Palaia T, Hall C E, Maesaka J K, Eguchi N, Urade Y, “Accelerated glucose intolerance, nephropathy, and atherosclerosis in prostaglandin D2 synthase knock-out mice”, J Biol Chem 280:29946-29955 (2005). Under conditions of PKC stimulation such as inflammation there is increased PKC activation leading to increased L-PGDS serine phosphorylation which results in the hypo-phosphorylation and activation of Bad, as well as the hypo-phosphorylation of retinoblastoma (pRb), both signaling increased apoptosis, See FIG. 9 . The ability to induce apoptosis with phorbol ester vanished in a cell line with depleted L-PGDS protein expression. [0012] Preliminary data indicate that PKC and p38MAPK signaling play a significant role in L-PGDS-mediated effects. The molecular mechanisms and signaling pathways responsible for L-PGDS action using a combination of PG's, synthetic DP1/DP2 receptor ligands, and specific pathway inhibitors in cultured A549 cells may be identified. L-PGDS may work autonomously or via the production of PGD 2 , and if so the role of the DP1 and DP2 receptors, or if one of the downstream PGD 2 derivatives working through PPARγ may be involved. Specific inhibitors of PI3-K, Akt, and PKC signaling, all pathways which have previously been determined to have a role in L-PGDS-induced apoptosis, may be utilized to tease out the signaling mechanisms responsible for L-PGDS action. [0013] PGD 2 , the enzymatic product of L-PGDS, and its metabolites also have interesting links with cancer. For example: PGD 2 has been linked to the inhibition of ovarian cancer. Miyauchi M, Kikuchi Y, Kizawa I, Oomori K, Kita T, Kato K, “[Inhibition of human ovarian cancer cell growth by prostaglandin D2]”, Nippon Sanka Fujinka Gakkai Zasshi 39:215-220 (1987); Kikuchi Y, Miyauchi M, Oomori K, Kita T, Kizawa I, Kato K, “Inhibition of human ovarian cancer cell growth in vitro and in nude mice by prostaglandin D2”, Cancer Res 46:3364-3366 (1986). Human erythromyeloblastoid leukemia cell proliferation is inhibited by PGD 2 . Santoro M G, Crisari A, Benedetto A, Amici C, “Modulation of the growth of a human erythroleukemic cell line (K562) by prostaglandins: antiproliferative action of prostaglandin A”, Cancer Res 46:6073-6077 (1986). PGD 2 has been suggested to represent a rational target for therapies aimed at reducing the incidence of colitis-associated colorectal cancer. Zamuner S R, Bak A W, Devchand P R, Wallace J L, “Predisposition to colorectal cancer in rats with resolved colitis: role of cyclooxygenase-2-derived prostaglandin d2”, Am J Pathol 167:1293-1300(2005). PGD 2 induces various transduction pathways and activates the function of SOX9. Malki S, Declosmenil F, Farhat A, Moniot B, Poulat F, Boizet-Bonhoure B, “[Prostaglandin D2: new roles in the embryonic and pathological gonad]”, Med Sci (Paris) 24:177-183 (2008). SOX9 is a transcription factor of which methylation has been linked to lung cancer. Cortese R, Hartmann O, Berlin K, Eckhardt F, “Correlative gene expression and DNA methylation profiling in lung development nominate new biomarkers in lung cancer”, Int J Biochem Cell Biol 40:1494-1508 (2008). Additionally, PGD 2 is non-enzymatically converted to 15-deoxy Δ 12,14 PGD 2 (15d-PGJ 2 ), a natural ligand for PPARγ, which plays an important role in the death of malignant T lymphocytes (Jurkat cells). Ferreira-Silva V, Rodrigues A C, Hirata T D, Hirabara S M, Curi R, “Effects of 15-deoxy-Delta12, 14 prostaglandin J2 and ciglitazone on human cancer cell cycle progression and death: the role of PPARgamma”, Eur J Pharmacol 580:80-86 (2008). In addition, PPARγ, expressed in lung cancer cells, can be activated by various ligands and can inhibit lung cancer cell growth through the induction of apoptosis. Zhang M, Zou P, Bai M, Jin Y, Tao X, “Peroxisome proliferator-activated receptor-gamma activated by ligands can inhibit human lung cancer cell growth through induction of apoptosis”, J Huazhong Univ Sci Technolog Med Sci 23:138-140 (2003). 15d-PGD 2 inhibits growth of A549 and H460 non-small-cell lung cancer cell lines and xenograft tumors; and in lung tumor cells, 15d-PGD 2 enhances the anti-tumor action of docetaxel by PPARγ-dependent and -independent mechanisms mediated by the induction of apoptosis. Fulzele S V, Chatterjee A, Shaik M S, Jackson T, Ichite N, Singh M, “15-Deoxy-Delta12,14-prostaglandin J2 enhances docetaxel anti-tumor activity against A549 and H460 non-small-cell lung cancer cell lines and xenograft tumors”, Anticancer Drugs 18:65-78 (2007). Furthermore, growth suppression of PPARγ expressing tumor cells by PGD 2 metabolites in the prostate microenvironment is likely to be an endogenous mechanism involved in tumor suppression that potentially contributes to the indolence and long latency period of this disease. Kim J, Yang P, Suraokar M, Sabichi A L, Llansa N D, Mendoza G, Subbarayan V, Logothetis C J, Newman R A, Lippman S M, Menter D G, “Suppression of prostate tumor cell growth by stromal cell prostaglandin D synthase-derived products”, Cancer Res 65:6189-6198 (2005). [0014] PGs can enhance or suppress inflammation in response to tumor growth by acting on various receptors. Two G protein-coupled receptors for PGD 2 , DP1 and DP2 have been identified. Activation of DP1 leads to the stimulation of adenylate cyclase activity and increased intracellular cAMP levels. DP2, is preferentially expressed on T-helper (Th) 2-type cells, T-cytotoxic (Tc) 2 cells, eosinophils and basophils. Tsuda H, Michimata T, Sakai M, Nagata K, Nakamura M, Saito S, “A novel surface molecule of Th2- and Tc2-type cells, CRTH2 expression on human peripheral and decidual CD4+ and CD8+ T cells during the early stage of pregnancy”, Clin Exp Immunol 123:105-111 (2001). DP2 induces intracellular calcium mobilization and chemotaxis in a Gαi-dependent manner. Hirai H, Tanaka K, Yoshie O, Ogawa K, Kenmotsu K, Takamori Y, Ichimasa M, Sugamura K, Nakamura M, Takano S, Nagata K, “Prostaglandin D2 selectively induces chemotaxis in T helper type 2 cells, eosinophils, and basophils via seven-transmembrane receptor CRTH2”, J Exp Med 193:255-261 (2001). One current set of data suggests that PGD 2 participates in the immunologic mechanisms which serve to establish and maintain pregnancy. Successful pregnancy implies avoidance of rejection of paternal antigens of fetal tissues by the maternal immune system. An important mechanism behind this immunological paradox involves the down-regulation of the cellular immune response. T-helper (Th) 1 and T-cytotoxic (Tc) 1 cells which produce interleukin (IL)-2, interferon (IFN)-γ, and tumour necrosis factor (TNF)-β are suppressed while Th2 and Tc2 cells, which produce IL-4, IL-6, IL-10 and IL-13 are upregulated. Michimata T, Ogasawara M S, Tsuda H, Suzumori K, Aoki K, Sakai M, Fujimura M, Nagata K, Nakamura M, Saito S, “Distributions of endometrial NK cells, B cells, T cells, and Th2/Tc2 cells fail to predict pregnancy outcome following recurrent abortion”, In: Am J Reprod Immunol; 196-202 (2002; Michimata T, Tsuda H, Sakai M, Fujimura M, Nagata K, Nakamura M, Saito S, “Accumulation of CRTH2-positive T-helper 2 and T-cytotoxic 2 cells at implantation sites of human decidua in a prostaglandin D(2)-mediated manner”, Mol Hum Reprod 8:181-187 (2002); Saito S, Tsuda H, Michimata T, “Prostaglandin D2 and reproduction”, Am J Reprod Immunol 47:295-302 (2002); Wegmann T G, Lin H, Guilbert L, Mosmann T R, “Bidirectional cytokine interactions in the maternal-fetal relationship: is successful pregnancy a TH2 phenomenon?”, Immunol Today 14:353-356 (1993). Present studies indicate possible imbalanced expression of prostanoid receptors in colorectal cancer compared to normal colon tissue without clear cut relationship to disease progression. Gustafsson A, Hansson E, Kressner U, Nordgren S, Andersson M, Lonnroth C, Lundholm K, “Prostanoid receptor expression in colorectal cancer related to tumor stage, differentiation and progression”, Acta Oncol 46:1107-1112 (2007). SUMMARY [0015] Prostaglandin D 2 (PGD 2 ) is a mediator in various pathophysiological processes, including inflammation and tumorigenesis. PGD 2 can be converted to active metabolites and is known to activate two distinct receptors, DP and chemoattractant receptor-homologous molecule expressed on Th2 cells (CRTH2/DP2). In the past, PGD 2 was thought to be involved only in the process of inflammation. However, in recent years, several studies have shown that PGD 2 has anti-proliferative ability against tumorigenesis and can induce cellular apoptosis via activation of the caspase-dependent pathway in human colorectal cancer cells, leukemia cells and eosinophils. In the lung, where PGD 2 is highly released when sensitized mast cells are challenged with allergen, the mechanism of PGD 2 -induced apoptosis is unclear. [0016] A549 cells, a type of non-small cell lung carcinoma (NSCLC) were treated with PGD 2 under various conditions, including while blocking DP and CRTH2/DP2 with the selective antagonists BWA868C and ramatroban, respectively. PGD 2 induces A549 cell death through the intrinsic apoptotic pathway, although the process does not appear to involve either DP or CRTH2/DP2. Similar results were also found with H2199 cells, other type of NSCLC. PGD 2 metabolites induce apoptosis effectively and that 15d-PGD2 is a likely candidate for the principal apoptotic inducer in PGD 2 -induced apoptosis in non-small cell lung carcinoma A549 cells. [0017] Altered dynamic expression of PGD 2 and its metabolites, via genetic L-PGDS modulation, is believed to alter susceptibility to carcinogen-induced lung cancer in mice. PGD 2 receptors, DP 1 and DP2, represent new therapeutic intervention points in the treatment of lung cancer. Some of the signaling pathways involved in L-PGDS action as well as the mechanisms through which L-PGDS regulates the delicate balance of PGs and cytokines during tumor progression are identified, and thus available as diagnostic and therapeutic targets. L-PGDS phosphorylation likely plays a role in relation to tumor progression, by reducing apoptosis. [0018] While it appears that broad inhibition of PG synthesis is excessively simple (see FIG. 8 ), one aspect of the present invention provides regulation at L-PGDS, a point downstream of PGH 2 , which may provide the mechanism necessary for fine-tuning PG signaling in a temporal and tissue-specific manner and offer a more efficacious chemotherapeutic site. [0019] Lipocalin-type prostaglandin D 2 synthase (L-PGDS) inhibits the progression of the cell cycle and also induces apoptosis in multiple cell lines. Furthermore, significantly less L-PGDS gene and protein expression is demonstrated in human non-small cell lung cancer (NSCLC) tumor types as compared to normal margins. [0020] Lipocalin-type prostaglandin D 2 synthase (L-PGDS) induces apoptosis and prevents cell cycle progression in several cell types. The expression of L-PGDS in a variety of human lung tumor types has been demonstrated. While L-PGDS expression was evident in the surrounding margins, significantly decreased protein and gene expression was observed in the tumor tissue. Using RTPCR, L-PGDS gene expression was shown to be decreased proportionately with tumor progression. In addition, exogenously added L-PGDS suppresses the hyperproliferation and PDGF-stimulated migration of A549 cells, a cultured carcinomic human alveolar basal epithelial cell line. L-PGDS may play a key role in modulating lung cancer growth and may offer a novel diagnostic and therapeutic approach for treatment. Ragolia L, Palaia T, Paric E, Maesaka J K, “Prostaglandin D2 synthase inhibits the exaggerated growth phenotype of spontaneously hypertensive rat vascular smooth muscle cells”, J Biol Chem 278:22175-22181 (2003). [0021] The expression of L-PGDS in lung tumors and the surrounding margin was examined. L-PGDS gene expression in lung tumors was monitored at various stages of progression using quantitative RT-PCR and the effects of exogenously added L-PGDS on proliferation and PDGF-stimulated migration of A549 cells, a cultured carcinomic human alveolar basal epithelial cell line, was investigated. [0022] Accordingly, the present invention provides a method for, diagnosing, detecting treating and predicting a future disease progression, predicting a responsiveness to pharmacological agents, predicting a metastatic state, and/or staging, a non small cell lung cancer (NSCLC), based on the differences in lipocalin-type prostaglandin D 2 synthase (L-PGDS) metabolism and expression activity between normal cells and various stages of cancer. [0023] NSCLC can be detected or diagnosed by ascertaining anomalous expression patterns of L-PGDS in tissue, and in particular, differences may be with respect to a normal margin, or other control tissue. [0024] NSCLC can be treated by disrupting the L-PGDS physiology of the malignant tissue, to induce apoptosis of the cells or prevent proliferation and metastasis. This can be achieved by administering pharmacological agents and/or gene therapy to the organism or particular tissues. The gene administered may, for example, encode Lipocalin-type prostaglandin D 2 synthase (EC=5.3.99.2), e.g., SEQ ID NO:005 [0000]         10         20         30         40         50         60  MATHHTLWMG LALLGVLGDL QAAPEAQVSV QPNFQQDKFL GRWFSAGLAS NSSWLREKKA         70         80         90        100        110        120  ALSMCKSVVA PATDGGLNLT STFLRKNQCE TRTMLLQPAG SLGSYSYRSP HWGSTYSVSV        130        140        150        160        170        180  VETDYDQYAL LYSQGSKGPG EDFRMATLYS RTQTPRAELK EKFTAFCKAQ GFTEDTIVFL        190  PQTDKCMTEQ (www.uniprot.org/uniprot/P41222, Homo sapiens, expressly incorporated herein by reference). [0025] Alternately, animal forms of the protein and/or synthetic or modified sequences may be employed. For example, residue may be changed from Arginine to Glutamine (R56Q), see expasy.org/cgi-bin/variant_pages/get-sprot-variant.pl?VAR — 004273. The therapeutic sequence may truncate the signal peptide residues 1-22, and use only the mature form residues 23-190, SEQ ID NO: 006: [0000] APEAQVSVQP NFQQDKFLGR WFSAGLASNS SWLREKKAAL SMCKSVVAPA TDGGLNLTST FLRKNQCETR TMLLQPAGSL GSYSYRSPHW GSTYSVSVVE TDYDQYALLY SQGSKGPGED FRMATLYSRT QTPRAELKEK FTAFCKAQGF TEDTIVFLPQ TDKCMTEQ [0026] The Lipocalin-type Prostaglandin D 2 Synthase of Homo sapiens is at LOCUS NM — 000954, and is transcribed as a 837 bp linear mRNA. The L-PGDS isolated from brain is 21 kDa. L-PGDS is variously known as beta-trace protein; PGD2 synthase; lipocalin-type prostaglandin D synthase; glutathione-independent PGD synthase; cerebrin-28; prostaglandin-D2 synthase; glutathione-independent PGD synthetase; lipocalin-type prostaglandin-D synthase, PTGDS; L-PGDS; LPGDS; PDS; PGD2; PGDS; PGDS2. [0027] The gene as the sequence SEQ ID NO:007: [0000] 1 gctcctcctg cacacctccc tcgctctccc acaccactgg caccaggccc cggacacccg 61 ctctgctgca ggagaatggc tactcatcac acgctgtgga tgggactggc cctgctgggg 121 gtgctgggcg acctgcaggc agcaccggag gcccaggtct ccgtgcagcc caacttccag 181 caggacaagt tcctggggcg ctggttcagc gcgggcctcg cctccaactc gagctggctc 241 cgggagaaga aggcggcgtt gtccatgtgc aagtctgtgg tggcccctgc cacggatggt 301 ggcctcaacc tgacctccac cttcctcagg aaaaaccagt gtgagacccg aaccatgctg 361 ctgcagcccg cggggtccct cggctcctac agctaccgga gtccccactg gggcagcacc 421 tactccgtgt cagtggtgga gaccgactac gaccagtacg cgctgctgta cagccagggc 481 agcaagggcc ctggcgagga cttccgcatg gccaccctct acagccgaac ccagaccccc 541 agggctgagt taaaggagaa attcaccgcc ttctgcaagg cccagggctt cacagaggat 601 accattgtct tcctgcccca aaccgataag tgcatgacgg aacaatagga ctccccaggg 661 ctgaagctgg gatcccggcc agccaggtga cccccacgct ctggatgtct ctgctctgtt 721 ccttccccga gcccctgccc cggctccccg ccaaagcaac cctgcccact caggcttcat 781 cctgcacaat aaactccgga agcaagtcag taaaaaaaaa aaaaaaaaaa aaaaaaa [0028] The coding sequence is as follows SEQ ID NO:008: [0000] 1 atggctactc atcacacgct gtggatggga ctggccctgc tgggggtgct gggcgacctg 61 caggcagcac cggaggccca ggtctccgtg cagcccaact tccagcagga caagttcctg 121 gggcgctggt tcagcgcggg cctcgcctcc aactcgagct ggctccggga gaagaaggcg 181 gcgttgtcca tgtgcaagtc tgtggtggcc cctgccacgg atggtggcct caacctgacc 241 tccaccttcc tcaggaaaaa ccagtgtgag acccgaacca tgctgctgca gcccgcgggg 301 tccctcggct cctacagcta ccggagtccc cactggggca gcacctactc cgtgtcagtg 361 gtggagaccg actacgacca gtacgcgctg ctgtacagcc agggcagcaa gggccctggc 421 gaggacttcc gcatggccac cctctacagc cgaacccaga cccccagggc tgagttaaag 481 gagaaattca ccgccttctg caaggcccag ggcttcacag aggataccat tgtcttcctg 541 ccccaaaccg ataagtgcat gacggaacaa tag [0029] The sequence may of course be modified in known manner, for example to increase or reduce enzymatic activity: [0030] 59 K→A: Increases enzyme activity about two-fold. [0031] 64 M→A: Reduces enzyme activity almost ten-fold. [0032] 79 L→A: Reduces enzyme activity over ten-fold. [0033] 83 F→A: Reduces enzyme activity about five-fold. [0034] 131 L→A: Reduces enzyme activity almost ten-fold. [0035] 149 Y→A: Increases enzyme activity about two-fold. [0036] See, Zhou Y., Shaw N., Li Y., Zhao Y., Zhang R., Liu Z. J., “Structure-function analysis of human 1-prostaglandin D synthase bound with fatty acid molecules.”, FASEB J. 24:4668-4677(2010) [PubMed: 20667974], expressly incorporated herein by reference. [0037] The DNA coding sequence may be as defined by: useast.ensembl.org/ Homo — sapiens /Transcript/Summary?g=ENSG00000107317;r=9:139871957-139876190;t=ENST00000371625, the entirety of which, and linked pages, are expressly incorporated herein by reference. See also, White, D M, Mikol D D, Espinosal R, Weimer B, Le Beau M M, Stefansson K, “Structure and Chromosomal Localization of the Human Gene for a Brain Form of Prostaglandin D2 Synthase”, The Journal of Biological Chemistry, 267, 23202-23208 (1992), expressly incorporated herein by reference. [0038] The invention also provides methods for detecting the L-PGDS peptides, gene or mRNA in a test sample for use in diagnosing the presence, absence or progression of a disease, or for prognosing a likely future course of a disease with respect to absence of treatment or various available therapeutic interventions. The test sample includes but is not limited to a biological sample such as tissue, blood, serum or biological fluid. [0039] The invention also provides a method for monitoring the disease progression and the treatment progress. The invention also provides a method for monitoring the disease progression and treatment regime, i.e., aggressive treatment proposed if prognosis is poor or is otherwise poor. [0040] The present invention provides a method for treating lung, colon, and prostate (e.g., neoplastic) diseases, comprising: identifying a subject having lung, colon or prostate disease; and administering to a patient to one or more compositions that increase PGD 2 levels, L-PGDS levels or activity or expression, in the lung, colon or prostate to alter a course of the subject having such disease. The subject may be human or animal. The composition is provided in a pharmaceutically acceptable carrier, in an effective dose. The composition is provided in an amount that avoids substantial toxicity to the subject while achieving an efficacious treatment. [0041] It is therefore an object to provide a method of treating a non small cell lung cancer, comprising administering an effective amount of a Prostaglandin D 2 (PGD 2 ) receptor agonist, in a pharmaceutically acceptable form, to a patient having non small cell lung cancer, in sufficient quantity to treat the non small cell lung cancer. The PGD 2 receptor agonist may, for example, comprise at least one of BW245C and BW868C. [0042] The method may further comprise performing an assay on the non small cell lung cancer cells to determine a Lipocalin-type prostaglandin D2 synthase (L-PGDS) activity or expression of the tissue, and administering the PGD2 agonist selectively in dependence on a determined low level of L-PGDS in the non small cell lung cancer cells. [0043] Another object provides a method of diagnosing, staging or predicting outcome of a non small cell lung cancer tumor, comprising testing cells of the non small cell lung cancer tumor for at least one of indicia or mRNA level corresponding to the Lipocalin-type prostaglandin D synthase (L-PGDS) gene, L-DPGS gene product, and PGD2 level, and scoring the test result with respect to non-cancer lung cells. The at least one indicia or mRNA level corresponding to the Lipocalin-type prostaglandin D synthase (L-PGDS) gene, L-PGDS gene product, and PGD2 level of the cells if showing at least a 25% reduction as compared to non-cancer lung cells from the same patient, may indicate a cancerous or precancerous condition. For example, a 40% reduction threshold may be employed to indicate a threshold for treatment. A 60% reduction as compared to non-cancer lung cells from the same patient may indicate, for example, a stage Ia cancer; an 80% reduction as compared to non-cancer lung cells from the same patient may indicate, for example, a stage a stage Ib cancer; a 90% reduction as compared to non-cancer lung cells from the same patient may indicate, for example, a stage a stage II cancer, and a 95% reduction as compared to non-cancer lung cells from the same patient may indicate, for example, a stage a stage IV cancer. For example, L-PGDS activity can be measured by RT-PCR using primers designed to specifically amplify L-PGDS mRNA. An mRNA level of Lipocalin-type prostaglandin D synthase (L-PGDS) gene transcript of the tested cells of less than 40% of non-cancerous lung cells from the same patient may indicate a poor prognosis if the patient is left untreated. An mRNA level of Lipocalin-type prostaglandin D synthase (L-PGDS) gene transcript of the tested cells of less than 40% of non-cancerous lung cells from the same patient may also be interpreted to indicate a likely effective response of the non small cell lung cancer tumor to a therapy which increases L-PGDS activity or agonizes PGD2 receptors in the non small cell lung cancer tumor. [0044] A further object provides a method of treating a non small cell lung cancer tumor in a patient, comprising testing cells from a biopsy of the non small cell lung cancer tumor for at least one of indicia or mRNA corresponding to the Lipocalin-type prostaglandin D synthase (L-PGDS) gene, L-PGDS gene product, and PGD2 level, and comparing the biopsied non small cell lung cancer tumor cells with control lung cells, and treating the non small cell lung cancer tumor with a treatment to increase L-PGDS or agonize PGD2 receptors in the non small cell lung cancer tumor selectively in dependence on the testing, wherein a reduced level of the at least one of indicia or mRNA corresponding to the Lipocalin-type prostaglandin D synthase (L-PGDS) gene, L-PGDS gene product, and PGD2 level indicates a likely favorable response to the treatment. [0045] A still further object provides a method of treating a patient having a non small cell lung cancer, comprising administering an effective amount of a gene therapy configured to cause expression in lung tissue of the patient of Lipocalin-type prostaglandin D synthase (L-PGDS). The gene therapy may, for example, comprises a genetically engineered adenovirus or SV40 virus comprising DNA encoding an L-PGDS. The L-PGDS may comprise a human L-PGDS EC=5.3.99.2, a mutant or synthetic form having higher or lower enzymatic activity, or a non-human enzyme. For example, the expressed L-PGDS may have an activity in the lung tissue higher than normal human L-PGDS. The gene therapy may be applied intratracheally. [0046] Combination therapies are specifically contemplated. Thus, in addition to administering an enzyme or a gene with encodes an enzymatically active produce, a patient may also receive a drug with serves as a substrate for the enzyme, or interacts with the same receptor as an enzyme product. Thus, for example, in addition to gene therapy for inducing increased L-PGDS activity in the patient's tumor, a PGD 2 receptor agonist may be administered to the patient. The PGD 2 receptor agonist, for example, may comprise at least one of BW245C and BW868C. [0047] It is also an object to provide a method to predict pathological characteristics of a non small cell lung cancer tumor in a patient, comprising: performing an assay to determine expression of a gene encoding an L-PGDS in the non small cell lung cancer tumor and a non-tumor margin; and categorizing the pathological characteristics of the non small cell lung cancer tumor, selectively in dependence on the assay. The patient may be further treated in accordance with the categorized pathological characteristics. BRIEF DESCRIPTION OF THE FIGURES [0048] FIGS. 1A-1E show significantly less L-PGDS protein expression in non-small cell lung cancer (NSCLC) as compared to normal margins; [0049] FIG. 2 shows that L-PGDS protein expression, as determined by fluorescence L-PGDs staining in the tumor tissue, decreases with adenocarcinoma stage. [0050] FIG. 3A shows a Western blot insert of L-PGDS protein expression in tumor versus margin; [0051] FIG. 3B shows a graph which demonstrated that L-PGDs gene expression is decreased several-fold in tumor when compared to normal tissue; [0052] FIG. 4 shows a graph which indicates that L-PGDS gene expression decreases with tumor progression, demonstrating that L-PGDs gene expression decreased proportionally with the stage of tumor progression when compared to normal lung tissue; [0053] FIG. 5A shows Western blots of L-PGDS protein expression in a lung carcinoma cell line versus control; [0054] FIG. 5B shows a graph indicating that L-PGDS expression is lower in A549 lung carcinoma cells than in controls; [0055] FIG. 6 shows a graph which indicates that exogenous L-PGDS suppresses A549 hyperproliferation; [0056] FIG. 7 shows micrographs which reveal that exogenous L-PGDS inhibits A549 migration; [0057] FIG. 8 shows a biochemical pathway for arachadonic acid metabolism; [0058] FIG. 9 shows a physiological pathway for the relationship of phorbol esters and inflammation on apoptosis; [0059] FIG. 10 shows a photograph of stained mouse lung showing lungs from control, L-PGDS knockouts, and transgenic L-PGDS overexpressing mice, two weeks after lung tumor induction. DESCRIPTION [0060] Development of more effective chemopreventive and chemotherapeutic agents with minimal toxicity to treat lung cancer is crucial. L-PGDS represents a very attractive site for the prevention/treatment of lung cancer for several reasons. First, L-PGDS induces cellular apoptosis, delays cell cycle progression, and inhibits cell proliferation and migration in multiple cell types. These are all important processes involved in tumor progression. In addition, L-PGDS, PGD 2 and its metabolites have also been linked to lung cancer. Secondly, recent efforts have attempted to illustrate the importance of identifying the molecular mechanisms by which PGE 2 promotes tumor growth and metastasis in order to develop safer strategies for cancer prevention and treatment. The balance between L-PGDS and PGE synthase, has incidentally been described as a major determinant of other disease processes such as atherosclerosis. Cipollone F, Fazia M, Iezzi A, Ciabattoni G, Pini B, Cuccurullo C, Ucchino S, Spigonardo F, De Luca M, Prontera C, Chiarelli F, Cuccurullo F, Mezzetti A, “Balance between PGD synthase and PGE synthase is a major determinant of atherosclerotic plaque instability in humans”, Arterioscler Thromb Vasc Biol 24:1259-1265 (2004). It is believed that the balance between L-PGDS and PGE synthase is also significant to lung cancer progression. Finally, an inverse relationship has been shown between L-PGDS gene and protein expression and lung tumor progression. Specific DP1/DP2 agonists and antagonists are available and equally attractive to study as potential therapeutics, e.g., BW245C (5-(6-carboxyhexyl)-1-(3-cyclohexyl-3-hydroxypropyl-hydantoin), AS702224, TS-022, 15R-methyl-PGD 2 , 13-14-dihydro-15-keto-PGD 2 , AM156, AM206, L-745870, 15R-PGD(2), MK-0524, BWA868C, BW24-SC, BAY-u3405, 15-deoxy-Delta12,14-prostaglandin J2 (15d-PGD2), 11-deoxy-11-methylene PGD 2 , G 0 6983 (PKCα,Δ,ε,ζ), G 0 6976 (PKCα), GF10923X (PKCα,Δ,ε), LY333531 (PKC β), SB203580 (p38MAPK), SB203580, CD200, FGF18, GPRC5D, GPR49, LRRC15, Serpin A, CDT6, BMP2, LHX2, THBS1, MYCN, NR4A2, MEST, TM4SF1, CRLF1, TNFRSF12A, SELENBP1, GPR161, HEPH, FZD7, and CLIC4, CCL18, Col11A1, Col3A1, CD4, Cd1a, FCER1A, HLA-C, HLA-DPA1, IGF1, GPR105, PDGFRL, ADRA2A, CCL19, CORN, 16-phenoxy-17,18,19,20-tetranor PGD 2 N-cyclopropylamide, 16-phenoxy-17,18,19,20-tetranor PGD 1 N-cyclopropylmethylamide, 16-phenoxy-17,18,19,20-PGD 1 N-(1,3-dihydroxypropan-2-yl))amide; 17-phenyl-18,19,20-trinor PGD 2 N-cyclopropylamide, 17-phenyl-18,19,20-trinor PGD 1 N-cyclopropylmethylamide, 17-phenyl-18,19,20-trinor PGD 2 N-(1,3-dihydroxypropan-2-yl))amide; 16-(3-chlorophenyl)-17,18,19,20-tetranor PGD 2 N-cyclopropylamide, 16-(3-chlorophenyl)-17,18,19,20-tetranor PGD 1 N-cyclopropylmethylamide, 6-(3-chlorophenyl)-17,18,19,20-tetranor PGD 1 N-(1,3-dihydroxypropan-2-yl))amide, (Z)-isopropyl 7-((R)-2-((R)-3-hydroxy-5-phenylpentyl)-5-oxocyclopent-2-enyl)hept-5-enoate, (Z)-isopropyl 7-((R)-2-((R,E)-3-hydroxy-4-(3-(trifluoromethyl)phenoxy)but-1-enyl)-5-oxo-cyclopent-2-enyl)hept-5-enoate, (Z)—N-ethyl-7-((R)-2-4R,E)-3-hydroxy-4-(3-(trifluoromethyl)phenoxy)but-1-enyl)-5-oxocyclopent-2-enyl)hept-5-enamide, (Z)—N-ethyl-7-((R)-2-((S,E)-3-hydroxy-5-phenylpent-1-enyl)-5-oxocyclopen-t-2-enyl)hept-5-enamide, (Z)-7-((R)-2-((R,E)-3-hydroxy-4-(3-(trifluoromethyl)phenoxy)but-1-enyl)-5- -oxocyclopent-2-enyl)hept-5-enoic acid, (Z)-7-((R)-2-((R,E)-3-hydroxy-4-(3-(trifluoromethyl)phenoxy)but-1-enyl)-5-oxocyclopent-2-enyl)-N-methylhept-5-enamide, (Z)-7-((R)-2-((R,E)-4-(3-chlorophenoxy)-3-hydroxybut-1-enyl)-5-oxocyclope-nt-2-enyl)hept-5-enoic acid, (Z)-isopropyl 7-((R)-2-((R,E)-4-(3-chlorophenoxy)-3-hydroxybut-1-enyl)-5-oxocyclopent-2-enyl)hept-5-enoate, (Z)-7-((R)-2-((R,E)-4-(3-chlorophenoxy)-3-hydroxybut-1-enyl)-5-oxocyclopent-2-enyl)-N-methylhept-5-enamide or a pharmaceutically acceptable salt, hydrate, solvate, prodrug or metabolite thereof. These agents may be used alone or in combination, and may be administered concurrently or sequentially. See also, 2011/0144160, 2011/0130453, 2011/0112134, 2011/0098352, 2011/0098302, 2011/0071175, 2011/0060026, 2011/0034558, 2011/0028717, 2011/0021599, 2011/0021573, 2011/0002866, 2010/0330077, each of which is expressly incorporated herein by reference. [0061] Pharmaceutical compositions for use in accordance with the present invention may be formulated in conventional manner using one or more physiologically acceptable carriers or excipients. [0062] A “pharmaceutically acceptable salt” is any salt that retains the activity of the parent compound and does not impart any additional deleterious or untoward effects on the subject to which it is administered and in the context in which it is administered compared to the parent compound. [0063] Pharmaceutically acceptable salts of acidic functional groups may be derived from organic or inorganic bases. The salt may be a mono or polyvalent ion. Of particular interest are the inorganic ions, lithium, sodium, potassium, calcium, and magnesium. Organic salts may be made with amines, particularly ammonium salts such as mono-, di- and trialkyl amines or ethanol amines. Salts may also be formed with caffeine, tromethamine and similar molecules. Hydrochloric acid or some other pharmaceutically acceptable acid may form a salt with a compound that includes a basic group, such as an amine or a pyridine ring. [0064] A “prodrug” is a compound which is converted to a therapeutically active compound after administration, and the term should be interpreted as broadly herein as is generally understood in the art. While not intending to limit the scope of the invention, conversion may occur by hydrolysis of an ester group or some other biologically labile group. Generally, but not necessarily, a prodrug is inactive or less active than the therapeutically active compound to which it is converted, or has different toxicology, bioavailability or pharmacology profile. [0065] Thus, the compounds and their physiologically acceptable salts and solvates may be formulated for administration by inhalation or insufflation (either through the mouth or the nose) or oral, buccal, parenteral, rectal, bronchial or topical administration. [0066] Formulations for oral administration in the present invention may be presented as: discrete units such as capsules, sachets or tablets each containing a predetermined amount of the active agent; as a powder or granules; as a solution or a suspension of the active agent in an aqueous liquid or a non-aqueous liquid; or as an oil-in-water liquid emulsion or a water in oil liquid emulsion; or as a bolus etc. [0067] For oral administration, the pharmaceutical compositions may take the form of, for example, tablets or capsules prepared by conventional means with pharmaceutically acceptable excipients such as binding agents (e.g., pregelatinised maize starch, polyvinylpyrrolidone or hydroxypropyl methylcellulose); fillers (e.g., lactose, microcrystalline cellulose or calcium hydrogen phosphate); lubricants (e.g., magnesium stearate, talc or silica); disintegrants (e.g., potato starch or sodium starch glycolate); or wetting agents (e.g., sodium lauryl sulphate). The tablets may be coated by methods well known in the art. Liquid preparations for oral administration may take the form of, for example, solutions, syrups or suspensions, or they may be presented as a dry product for constitution with water or other suitable vehicle before use. Such liquid preparations may be prepared by conventional means with pharmaceutically acceptable additives such as suspending agents (e.g., sorbitol syrup, cellulose derivatives or hydrogenated edible fats); emulsifying agents (e.g., lecithin or acacia); non-aqueous vehicles (e.g., almond oil, oily esters, ethyl alcohol or fractionated vegetable oils); and preservatives (e.g., methyl or propyl-p-hydroxybenzoates or sorbic acid). The preparations may also contain buffer salts, flavoring, coloring and sweetening agents as appropriate. [0068] For compositions for oral administration (e.g. tablets and capsules), the term “acceptable carrier” includes vehicles such as common excipients e.g. binding agents, for example syrup, acacia, gelatin, sorbitol, tragacanth, polyvinylpyrrolidone (Povidone), methylcellulose, ethylcellulose, sodium carboxymethylcellulose, hydroxypropylmethylcellulose, sucrose and starch; fillers and carriers, for example corn starch, gelatin, lactose, sucrose, microcrystalline cellulose, kaolin, mannitol, dicalcium phosphate, sodium chloride and alginic acid; and lubricants such as magnesium stearate, sodium stearate and other metallic stearates, glycerol stearate, stearic acid, silicone fluid, talc waxes, oils and colloidal silica. Flavouring agents such as peppermint, oil of wintergreen, cherry flavouring and the like can also be used. It may be desirable to add a colouring agent to make the dosage form readily identifiable. Tablets may also be coated by methods well known in the art. [0069] A tablet may be made by compression or moulding, optionally with one or more accessory ingredients. Compressed tablets may be prepared by compressing in a suitable machine the active agent in a free flowing form such as a powder or granules, optionally mixed with a binder, lubricant, inert diluent, preservative, surface-active or dispersing agent. Moulded tablets may be made by moulding in a suitable machine a mixture of the powdered compound moistened with an inert liquid diluent. The tablets may optionally be coated or scored and may be formulated so as to provide slow or controlled release of the active agent. Preparations for oral administration may be suitably formulated to give controlled release of the active compound. [0070] For solid dosage forms, non-toxic solid carriers include, but are not limited to, pharmaceutical grades of mannitol, lactose, starch, magnesium stearate, sodium saccharin, the polyalkylene glycols, talcum, cellulose, glucose, sucrose and magnesium carbonate. The solid dosage forms may be uncoated or they may be coated by known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period. For example, a time delay material such as glyceryl monostearate or glyceryl distcarate may be employed. They may also be coated by the technique described in the U.S. Pat. Nos. 4,256,108; 4,166,452; and 4,265,874 to form osmotic therapeutic tablets for control release. Liquid pharmaceutically administrable dosage forms can, for example, comprise a solution or suspension of one or more of the presently useful compounds and optional pharmaceutical adjutants in a carrier, such as for example, water, saline, aqueous dextrose, glycerol, ethanol and the like, to thereby form a solution or suspension. If desired, the pharmaceutical composition to be administered may also contain minor amounts of nontoxic auxiliary substances such as wetting or emulsifying agents, pH buffering agents and the like. Typical examples of such auxiliary agents are sodium acetate, sorbitan monolaurate, triethanolamine, sodium acetate, triethanolamine oleate, etc. Actual methods of preparing such dosage forms are known, or will be apparent, to those skilled in this art; for example, see Remington's Pharmaceutical Sciences, Mack Publishing Company, Easton, Pa., 16th Edition, 1980. The composition of the formulation to be administered, in any event, contains a quantity of one or more of the presently useful compounds in an amount effective to provide the desired therapeutic effect. [0071] Other formulations suitable for oral administration include lozenges comprising the active agent in a flavoured base, usually sucrose and acacia or tragacanth; pastilles comprising the active agent in an inert base such as gelatin and glycerin, or sucrose and acacia; and mouthwashes comprising the active agent in a suitable liquid carrier. [0072] For buccal administration the compositions may take the form of tablets or lozenges formulated in conventional manner. [0073] For administration by inhalation, the compounds for use according to the present invention are conveniently delivered in the form of an aerosol spray presentation from pressurized packs or a nebulizer, with the use of a suitable propellant, e.g., dichlorodifluoromethane, trichlorofluoromethane, dichlorotetrafluoroethane, carbon dioxide or other suitable gas. In the case of a pressurized aerosol the dosage unit may be determined by providing a valve to deliver a metered amount. Capsules and cartridges of e.g. gelatin for use in an inhaler or insufflator may be formulated containing a powder mix of the compound and a suitable powder base such as lactose or starch. [0074] Compounds may be used for the treatment of the respiratory tract by nasal, bronchial or buccal administration of, for example, aerosols or sprays which can disperse the pharmacological active ingredient in the form of a powder or in the form of drops of a solution or suspension. Pharmaceutical compositions with powder-dispersing properties usually contain, in addition to the active ingredient, a liquid propellant with a boiling point below room temperature and, if desired, adjuncts, such as liquid or solid non-ionic or anionic surfactants and/or diluents. Pharmaceutical compositions in which the pharmacological active ingredient is in solution contain, in addition to this, a suitable propellant, and furthermore, if necessary, an additional solvent and/or a stabiliser. Instead of the propellant, compressed air can also be used, it being possible for this to be produced as required by means of a suitable compression and expansion device. [0075] A number of medicinal aerosol formulations using propellant systems are disclosed in, for example, U.S. Pat. No. 6,613,307 and the references cited therein (such as, for example, EP 0372777, WO91/04011, WO91/11173. WO91/11495, WO91/14422, WO92/00107, WO93/08447, WO93/08446. WO93/11743, WO93/11744 and WO93/11745) all of which are incorporated by reference herein in their entirety. The propellants for use in the invention may be any fluorocarbon, hydrogen-containing fluorocarbon or hydrogen-containing chlorofluorocarbon propellant or mixtures thereof having a sufficient vapour pressure to render them effective as propellants. The propellant may additionally contain a volatile adjuvant such as a saturated hydrocarbon for example propane, n-butane, isobutane, pentane and isopentane or a dialkyl ether for example dimethyl ether. [0076] Where a surfactant is employed in the aerosol, it is selected from those which are physiologically acceptable upon administration by inhalation such as oleic acid, sorbitan trioleate (Span R 85), sorbitan mono-oleate, sorbitan monolaurate, polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, natural lecithin, fluorinated and perfluorinated surfactants including fluorinated lecithins, fluorinated phosphatidylcholines, oleyl polyoxyethylene (2) ether, stearyl polyoxyethylene (2) ether, lauryl polyoxyethylene (4) ether, block copolymers of oxyethylene and oxypropylene, synthetic lecithin, diethylene glycol dioleate, tetrahydrofurfuryl oleate, ethyl oleate, isopropyl myristate, glyceryl monooleate, glyceryl monostearate, glyceryl monoricinoleate, cetyl alcohol, stearyl alcohol, polyethylene glycol 400, cetyl pyridinium chloride, benzalkonium chloride, olive oil, glyceryl monolaurate, corn oil, cotton seed oil and sunflower seed oil. See, for example, U.S. Pat. No. 6,613,307. [0077] The compounds may be formulated for parenteral administration by injection, either subcutaneously, intramuscularly or intravenously, e.g., by bolus injection or continuous infusion. Formulations for injection may be presented in unit dosage form, e.g., in ampules or in multi-dose containers, with an added preservative. The compositions may take such forms as suspensions, solutions or emulsions in oily or aqueous vehicles, and may contain formulatory agents such as suspending, stabilizing and/or dispersing agents. Alternatively, the active ingredient may be in powder form for constitution with a suitable vehicle, e.g., sterile pyrogen-free water, before use. Injectables can be prepared in conventional forms, either as liquid solutions or suspensions, solid forms suitable for solution or suspension in liquid prior to injection, or as emulsions. Suitable excipients are, for example, water, saline, dextrose, glycerol, ethanol and the like. In addition, if desired, the injectable pharmaceutical compositions to be administered may also contain minor amounts of non-toxic auxiliary substances such as wetting or emulsifying agents, pH buffering agents and the like. Parenteral formulations will generally be sterile. [0078] The compounds may also be formulated in rectal compositions such as suppositories or retention enemas, e.g., containing conventional suppository bases such as cocoa butter or other glycerides. [0079] For topical use, creams, ointments, gels, solutions or suspensions, etc., containing the compound disclosed herein are employed. Topical formulations may generally be comprised of a pharmaceutical carrier, cosolvent, emulsifier, penetration enhancer, preservative system, and emollient. [0080] In addition to the formulations described previously, the compounds may also be formulated as a depot preparation. Such long acting formulations may be administered by implantation (for example subcutaneously or intramuscularly) or by intramuscular injection. Thus, for example, the compounds may be formulated with suitable polymeric or hydrophobic materials (for example as an emulsion in an acceptable oil) or ion exchange resins, or as sparingly soluble derivatives, for example, as a sparingly soluble salt. [0081] The compositions may, if desired, be presented in a pack or dispenser device which may contain one or more unit dosage forms containing the active ingredient. The pack may for example comprise metal or plastic foil, such as a blister pack. The pack or dispenser device may be accompanied by instructions for administration. [0082] Those skilled in the art will readily understand that for administration the compounds disclosed herein can be admixed with pharmaceutically acceptable excipients which per se are well known in the art. Specifically, a drug to be administered systemically, it may be confected as a powder, pill, tablet or the like, or as a solution, emulsion, suspension, aerosol, syrup or elixir suitable for oral or parenteral administration or inhalation. [0083] The amount of the presently useful compound or compounds administered is, of course, dependent on the therapeutic effect or effects desired, on the specific mammal being treated, on the severity and nature of the mammal's condition, on the manner of administration, on the potency and pharmacodynamics of the particular compound or compounds employed, and on the judgement of the prescribing physician. [0084] Preservatives that may be used in the pharmaceutical compositions of the present invention include, but are not limited to, benzalkonium chloride, chlorobutanol, thimerosal, phenylmercuric acetate and phenylmercuric nitrate. A useful surfactant is, for example, Tween 80. Likewise, various useful vehicles may be used in the ophthalmic preparations of the present invention. These vehicles include, but are not limited to, polyvinyl alcohol, povidone, hydroxypropyl methyl cellulose, poloxamers, carboxymethyl cellulose, hydroxyethyl cellulose and purified water. See, www.pharmainfo.net/reviews/analysis-preservatives-pharmaceutical-products. [0085] The carrier, or, if more than one be present, each of the carriers, must be acceptable in the sense of being compatible with the other ingredients of the formulation and not deleterious to the recipient. [0086] Typically, the dose of a prostaglandin agonist or antagonist will be about 0.01 to 100 mg/kg; so as to maintain the concentration of drug in the plasma at a concentration effective to agonize or antagonize the receptor. The precise amount of a compound which is therapeutically effective, and the route by which such compound is best administered, is readily determined by one of ordinary skill in the art by comparing the blood level of the agent to the concentration required to have a therapeutic effect. The actual dose of the active compounds of the present invention depends on the specific compound, and on the condition to be treated; the selection of the appropriate dose is well within the knowledge of the skilled artisan. [0087] Tonicity adjustors may be added as needed or convenient. They include, but are not limited to, salts, particularly sodium chloride, potassium chloride, mannitol and glycerin, or any other suitable ophthalmically acceptable tonicity adjustor. [0088] Other excipient components which may be included in the ophthalmic preparations are chelating agents. A useful chelating agent is edentate disodium, although other chelating agents may also be used in place or in conjunction with it. [0089] See, e.g., U.S. 2002/0022218, 2004/0162323, 2011/0142855, 2004/0122059, each of which expressly incorporated herein by reference. [0090] L-PGDS, or other relevant peptides disclosed herein, can be delivered intra-tracheally to the lung, or for absorption into the vascular system. 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Cancer 26(6), 738-740 (1990); Martin P, Vaidyanathan S, Lane J et al.: Safety and systemic absorption of pulmonary delivered human ifn-β1a in the nonhuman primate: comparison with subcutaneous dosing. J. Interferon Cytokine Res. 22(6), 709-717 (2002); Halme M, Maasilta P, Repo H et al.: Inhaled recombinant interferon-γ in patients with lung cancer: pharmacokinetics and effects on chemiluminescence responses of alveolar macrophages and peripheral blood neutrophils and monocytes. Int. J. Radiat. Oncol. Biol. Phys. 31(1), 93-101 (1995); Eichelberg C, Andreas A, Heuer R, Huland H, Heinzer H, Huland E: Long-term tumor control with inhalational interleukin 2 therapy in cardiac high risk patients with metastatic renal carcinoma. J. Urol. 179(4), 167-167 (2008); Adjei A, Sundberg D, Miller J, Chun A: Bioavailability of leuprolide acetate following nasal and inhalation delivery to rats and healthy humans. Pharm. Res. 9(2), 244-249 (1992); Adjei A, Garren J: Pulmonary delivery of peptide drugs: effect of particle size on bioavailability of leuprolide acetate in healthy male volunteers. Pharm. Res. 7(6), 565-569 (1990); Tazawa R, Nakata K, Inoue Y, Nukiwa T: Granulocyte-macrophage colony-stimulating factor inhalation therapy for patients with idiopathic pulmonary alveolar proteinosis: a pilot study; and long-term treatment with aerosolized granulocyte-macrophage colony-stimulating factor: a case report. Respirology11(Suppl.) S61-S64 (2006); US2006/0120969 (2006), each of which is expressly incorporated herein by reference. [0091] One aspect of the cancer stem cell hypothesis is that patients with tumors that exhibit stem-like phenotypes have poor prognoses. Distal epithelial progenitors from lungs early in development demonstrate both self-renewal and potential to differentiate into all bronchial and alveolar epithelial cell types. By contrast, late progenitors are only able to produce alveolar cells. The various differentiated cell types have different gene expression characteristics. Low L-PGDS expression has been found associated (along with 9 other genes) with a predicted poor prognosis in human lung cancer. “A 10-Gene Progenitor Cell Signature Predicts Poor Prognosis in Lung Adenocarcinoma” Onaitis M, D'Amico T A, Clark C P, Guinney J, Harpole D H, Rawlins E L, Ann Thorac Surg 2011; 91:1046-50. EXAMPLE 1 [0092] Given available L-PGDS data involving apoptosis, cell cycle and migration in various cell types, as well as the preponderance of data linking L-PGDS to cancer, the expression of L-PGDS in tumor versus normal tissue as well as the margin of various types of lung cancer was investigated. As can be seen in FIG. 1A-1E , immunohistochemical fluorescence staining shows significantly less L-PGDS protein expression in human non-small cell lung cancer (NSCLC) tumor types as compared to normal margins. [0093] Furthermore, lung tissue sections with varying grades adenocarcinoma revealed that the fluorescence L-PGDS staining in the tumor tissue was significantly lower than margin and decreased with grade progression, as shown in FIG. 2 . [0094] L-PGDS gene expression in human lung tumors of various grades (Ia, Ib, IIb, and IV) was examined by RT-PCR using a Tissue Scan Lung Cancer Tissue qPCR Array I (Origene Technologies, Rockville, Md., Part #HLRT101). L-PGDS gene expression decreased proportionately with the stage of tumor progression when compared to normal lung tissue, as shown in FIG. 4 . [0095] Experiments were performed in culture of both control mouse lung epithelial (MLE) cells and the carcinomic human alveolar basal epithelial cell line (A549) to assess both L-PGDS gene and protein expression. As can be seen in the right side of FIG. 5B , there is a 10-fold decrease in L-PGDS gene expression in A549 when compared to MLE as determined by RT-PCR. In addition, a 6-fold decrease in L-PGDS protein expression was observed in A549 when compared to controls. [0096] The effect of exogenously added L-PGDS on lung cell growth in culture was determined by MTS proliferation assay (Promega, Madison, Wis.). A marked inhibition of A549 cell proliferation over the entire range of L-PGDS (1-50 mg/l) was observed after 18 h incubation. MLE cell proliferation was unaffected at L-PGDS concentrations up to 10 mg/dl but ceased at a concentration of 25 mg/l and above, as shown in FIG. 6 . [0097] Elevated L-PGDS expression has been shown to help minimize tumor growth and L-PGDS knockout mice will be more susceptible to tumor growth than normal mice. [0098] Cell culture reagents, including fetal bovine serum and platelet derived growth factor-BB (PDGF), were all purchased from Life Technologies (Grand Island, N.Y.). SDS/polyacrylamide gel electrophoresis and western blot reagents were from Bio-Rad (Hercules, Calif.). Bicinchoninic acid protein assay reagent was purchased from Pierce (Rockford, Ill.). Western blots were visualized with enhanced chemiluminescence reagent purchased from Amersham Pharmacia Biotech (Piscataway, N.J.). Type-1 collagenase was from Worthington Biochemical Co. (Freehold, N.J.). All other reagents were purchased from the Sigma Chemical Co. (St. Louis, Mo.). [0099] The Normal Lung Tissue Array (NC04-01) and Lung Adenocarcinoma Tissue Array (C504-08) were purchased from CYBRDI Inc. (Rockville, Md.). TissueScan Real Time Cancer Expression Panel (HLRT 101) was purchased from Origene (Rockville, Md.). In addition, we procured tumor and surrounding margin from eight lung adenocarcinomas to help support the commercial tissue array data. [0100] Sections were deparafinized in a xylene/ethanol series; antigen unmasked in 10 mM citric acid and blocked in 10% goat serum in PBS. The primary antibody was an L-PGDS monoclonal raised in rat (Cayman, Ann Arbor, Mich.) diluted 1:1000 in 1.5% goat serum and incubated overnight at 4° C. The secondary antibody was a FITC labeled goat anti-rat (Santa Cruz Biotechnology, Santa Cruz, Calif.) diluted 1:20 in 10% goat serum. Sections were visualized with a Nikon Eclipse TE 300 fluorescent microscope. Control slides were incubated with nonspecific primary anti-sera or in some cases without the primary antibody. In no case did controls show a positive signal. [0101] Typically, 50 μg of whole cell protein lysate was mixed with Laemmli sample buffer containing 0.1% bromophenol blue; 1.0M NaH2PO4, pH 7.0; 50% glycerol and 10% SDS, boiled for 5 min and loaded on an SDS 10% polyacrylamide gel. The separated proteins were transferred to polyvinylidene difluoride membrane (Bio-Rad, Hercules, Calif.), probed with the proper primary antibodies followed by 1:2000 diluted secondary antibody and detected with enhanced chemiluminescence reagent (GE Healthcare, Piscataway, N.J.) and subsequent autoradiography. The intensity of the signal was quantitated by densitometric analysis using SigmaGel 1.0 software (Jandel/Systat Inc., San Jose, Calif.). [0102] RNA was isolated from confluent cells or lung tissue with Trizol (Invitrogen, Carlsbad, Calif.) according to the manufacturer's protocol. First strand cDNAs were prepared from 2 μg RNA of each sample using the Transcriptor High Fidelity cDNA Synthesis Kit for RT-PCR (Roche, Indianapolis, Ind.) according to the manufacturer's protocol. Primers for targets L-PGDS or the reference GAPDH were designed with Beacon Designer software using sequences found in the NCBI gene bank based on the criteria that they were at least 20 nucleotides in length had a Tm of approximately 60° C., and an amplicon length of between 75 and 200 bp. [0000] L-PGDS: SEQ ID NO: 001 Forward 5′GAA GAA GGC GGC GTT GTC-3′, SEQ ID NO: 002 Reverse 5′-GAG GAA GGT GGA GGT CAG G-3′; GAPDH: SEQ ID NO: 003 Forward 5′-GCT CTC TGC TCC TCC TGT TC-3′, SEQ ID NO: 004 Reverse 5′-GAC TCC GAC CTT CAC CTT CC-3′. [0103] Quantitative RT-PCR was performed in duplicate on a LightCycler 480 using the Syber-Green I Master Mix (Roche). A final reaction volume of 20 μl containing 2 μl cDNA, 10 μl MasterMix, 1 μl of each primer (0.5 μM), and 6 μl of PCR grade water was used. The reaction was performed with a denaturation step of 95° C. for 5 min followed by 40 cycles at 95° C. for 45 s, 61° C. for 1 min, and 72° C. for 1 min. For the creation of standard curves, cDNA from a test sample was diluted 1:3, followed by a 5-fold dilution to yield a final 1:375 dilution. All reactions were run with a negative control and subjected to melting curve analysis. Fold changes in gene expression were calculated using the Pfaffl method. [0104] A549, a human non-small cell carcinoma line that exhibits type II-like alveolar epithelial characteristics was obtained from the American Type Culture Collection, and cultured in RPMI and supplemented with 5% fetal bovine serum (FBS), 100 U/ml penicillin and 100 μg/ml streptomycin, and grown in a humidified atmosphere of 5% CO2 at 37° C. Cell Proliferation Assay [0105] Cell proliferation was measured with the use of a CellTiter 96 AQeous Non-Radioactive Cell Proliferation Assay (Promega, Madison, Wis.). Briefly, cells were plated in 96-well plates at a density of 500 cells/well in 200 μl of medium with 5% FBS. The cells were incubated at 37° C. in a humidified 5% CO2 atmosphere for the indicated time, after which 20 μl of combined MTS/PMS solution (Promega) was added per well. After a 2 h incubation at 37° C., absorbance at 490 nm was measured using an enzyme-linked immunosorbent assay (ELISA) plate reader. Data represent the average absorbance of three experiments each performed in triplicate. [0106] Migration assays were performed using 24-well cell culture inserts with 8.0 μm polyethylene terephthalate cyclopore membranes (Falcon) as detailed in Lundberg M S, Curto K A, Bilato C, Monticone R E, Crow M T. Regulation of vascular smooth muscle migration by mitogen-activated protein kinase and calcium/calmodulin-dependent protein kinase II signaling pathways. J Mol Cell Cardiol 1998; 30:2377-89. The underside of the membrane was coated with 100 μl rat tail collagen type I (50 μg/ml) for 18-20 h, washed and air-dried before each experiment. Cells were trypsinized and re-suspended in RPMI. Then 2×104 cells/250 μl were loaded into the cell culture inserts. The inserts were then added to the wells of 24-well plates which were filled with PDGF-BB diluted in RPMI with 0.1% BSA, and where indicated, L-PGDS was also added to this medium below the inserts. [0107] The chambers were then incubated at 37° C. for 5 h to allow for cell migration. Afterwards, cells were completely removed from the upper side of the membrane with a cotton swab and the remaining migrated cells fixed and stained with Diff-Quik® solution (Dade Behring, Newark, Del.). Results are reported as the mean+/−SEM of five different fields, from three experiments, counted at 200× magnification. [0108] Experimental results are reported as means±SEM. Data was analyzed by one-way ANOVA for comparisons of multiple data sets and by Student's t-test for comparison of two data sets using SigmaStat 3.5 (Systat), with statistical significance set at P<0.05. [0109] [000102] Given previous L-PGDS data involving apoptosis, cell cycle and migration in various cell types, as well as the preponderance of data linking L-PGDS to cancer; the expression of L-PGDS was investigated in lung tumor versus normal tissue as well as the margin of various types of lung cancer using a commercially available tissue array. [0110] FIGS. 1A-1E presents Immunohistochemical fluorescence staining images, which show significantly less L-PGDS protein expression in human non-small cell lung cancer (NSCLC) tumor types when compared to normal lung tissue and tumor margins. The Normal Lung Tissue Array (NC04-01) purchased from CYBRDI Inc. (Rockville, Md.) was treated as described above and incubated with monoclonal L-PGDS antibody diluted 1:1000 followed by FITC-labeled goat anti-rat (Santa Cruz Biotechnology, Santa Cruz, Calif.) diluted 1:20 in 10% goat serum. Sections were visualized with a Nikon Eclipse TE 300 fluorescent microscope at 200× magnification. [0111] Differences between normal/margin and tumor L-PGDS expression were most pronounced in adenocarcinoma and adenosquamous cells ( FIGS. 1A and D, respectively). [0112] Analysis of a lung tissue array of various stages adenocarcioma demonstrated a decrease in L-PGDS expression with increasing tumor stage, as shown in FIG. 2 . The fluorescence stained images of FIG. 2 show a Lung Adenocarcinoma Tissue Array (C504-08) purchased from CYBRDI Inc. (Rockville, Md.) which was treated as described above and incubated with monoclonal L-PGDS antibody diluted 1:1000 followed by FITC-labeled goat anti-rat (Santa Cruz Biotechnology, Santa Cruz, Calif.) diluted 1:20 in 10% goat serum. Sections were visualized with a Nikon Eclipse TE 300 fluorescent microscope at 200× magnification. [0113] The absence of L-PGDS protein expression in ten lung adenocarcinoma and corresponding margin homogenates. A representative western blot is provided in FIG. 3A . There was an unambiguous absence of L-PGDS protein expression in the tumor when compared to healthy margin along with an average 8-fold decrease in L-PGDS gene expression, as shown in FIG. 3B . Protein lysates (50 μg) were isolated from an adenocarcinoma (lane 1) and corresponding margin (lane 2) and subjected to Western analysis to quantify L-PGDS protein expression as described above ( FIG. 3A ). First strand cDNAs were prepared from 2.5 μg RNA of each sample and L-PGDS gene expression, expressed as -fold versus GAPDH, was examined by quantitative RT-PCR performed in triplicate on a LightCycler 480 as described above, see FIG. 3B . Asterisk (*) represents P<0.01 versus control. [0114] L-PGDS gene expression was examined in a variety of human lung tumors of various grades (Ia, Ib, IIb, and IV) by RTPCR using a TissueScan Lung Cancer Tissue qPCR Array I (Origene Technologies, Rockville, Md., Part #HLRT101). LPGDS gene expression decreased proportionately with the stage of tumor progression when compared to normal lung tissue ( FIG. 4 ). [0115] FIG. 4 shows L-PGDS gene expression decreases with tumor progression. A TissueScan Real Time Cancer Expression Panel (HLRT 101) from Origene Tech., Inc. (Rockville, Md.) was used to quantify L-PGDS expression. Sections were processed according to manufacturer's instructions and quantitative RT-PCR performed in duplicate on a Roche LightCycler 480 using a Sybr-Green I Master Mix (Roche). The reaction was performed with a denaturation step of 50° C. for 2 min then 95° C. for 5 min followed by 40 cycles at 95° C. for 45 s, 61° C. for 1 min, and 72° C. for 1 min with primers described in Section 2. All reactions were run with a negative control and subjected to melting curve analysis. Fold changes in gene expression were calculated using the Pfaffl method. [0116] Similar patterns of L-PGDS protein and gene expressions were observed in cultured lung epithelial cells. As seen in FIG. 5A , there was a 4-fold decrease in L-PGDS protein expression in the human non-small cell carcinoma A549 cell line when compared to controls. [0117] Similarly, there was also a 10-fold decrease in L-PGDS gene expression in the A549 cells compared to controls as determined by RT-PCR ( FIG. 5B ). [0118] FIG. 5B thus shows L-PGDS expression in A549 cells. Protein lysates (50 μg) were isolated from cultured cells and subjected to Western analysis to quantify L-PGDS protein expression as described above (panel A). The expression of μ-actin was used to normalize L-PGDS expression. First strand cDNAs were prepared from 2.5 μg RNA of each sample and L-PGDS gene expression, expressed as -fold versus GAPDH, was monitored via quantitative RT-PCR performed in duplicate on a LightCycler 480 as described above (panel B). Asterisk (*) represents P<0.01 versus control. [0119] The effect of exogenously added L-PGDS on A549 proliferation was observed. There was a dose responsive inhibition of A549 hyper-proliferative growth (proliferation determined after 2 h) in the presence of exogenously added L-PGDS (0, 10, 25, 50 μg/ml) which mimicked control cells after a concentration of 25 μg/μl expressed as OD490nm, as shown in FIG. 6 . [0120] The effect of L-PGDS on A549 migration was examined using trans-well inserts. FIG. 7 illustrates a 42% decrease in PGDF stimulated A549 migration in the presence of 25 μg/μl L-PGDS and a 77% decrease in the presence of 50 μg/μl L-PGDS. The addition of 100 μg/μl L-PGDS offered no further increase in migration inhibition (data not shown) and would support the notion that the L-PGDS effect is primarily due to alteration in migration as opposed to apoptotic influences. Cells were cultured and loaded into collagen coated 12-well cell culture inserts in the absence or presence of L-PGDS (25 or 50 μg/ml) as described above. Actual fields at 200× magnification are presented. [0121] L-PGDS induces cellular apoptosis, delaying cell cycle progression, and inhibiting cell proliferation and migration in multiple cell types. Ragolia L, Palaia T, Paric E, Maesaka J K. Prostaglandin D2 synthase inhibits the exaggerated growth phenotype of spontaneously hypertensive rat vascular smooth muscle cells. J Biol Chem 2003; 278:22175-81; Ragolia L, Palaia T, Koutrouby T B, Maesaka J K. Inhibition of cell cycle progression and migration of vascular smooth muscle cells by prostaglandin D2 synthase: resistance in diabetic Goto-Kakizaki rats. Am J Physiol Cell Physiol 2004; 287:C1273-81; Maesaka J K, Palaia T, Frese L, Fishbane S, Ragolia L. Prostaglandin D(2) synthase induces apoptosis in pig kidney LLC-PK1 cells. Kidney Int 2001; 60:1692-8. The absence of L-PGDS protein and gene expression in NSCLC was demonstrated ( FIGS. 1-3 ). Furthermore, an inverse relationship between L-PGDS gene expression and lung tumor progression was observed ( FIG. 4 ). The use of lung tissue arrays allows a comparison of a wide range of lung tumor samples which was consistent with the data obtained from pathological tissue samples. [0122] A549 cells were used as a model cell line to examine basal L-PGDS expression as well as the effect of exogenously added L-PGDS on cell proliferation and migration. Interestingly, basal L-PGDS expression was lower in A549 cells when compared to controls ( FIG. 5 ). Exogenously added LPGDS was able to suppress A549 hyperproliferation and migration ( FIGS. 6 and 7 ), supporting a mechanistic role in lung tumor progression for L-PGDS. [0123] The development of more effective chemopreventive and chemotherapeutic agents with minimal toxicity to treat lung cancer is crucial. Recent efforts have attempted to illustrate the importance of identifying the molecular mechanisms by which PGs promotes tumor growth and metastasis in order to develop safer strategies for cancer prevention and treatment. Wang D, Dubois R N. Prostaglandins and cancer. Gut 2006; 55:115-22. The initial excitement of using COX-2 inhibitors as practical chemopreventives was dampened by the undesirable cardiovascular side effects observed after prolonged use Rahme E, Nedjar H. Risks and benefits of COX-2 inhibitors vs non-selective NSAIDs: does their cardiovascular risk exceed their gastrointestinal benefit? A retrospective cohort study. Rheumatology (Oxford) 2007; 46:435-8; Solomon S D, McMurray J J, Pfeffer M A, Wittes J, Fowler R, Finn P, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005; 352:1071-80. While it appears that such broad inhibition of PG synthesis may be too far upstream, regulation of L-PGDS, a point downstream of PGH2, may provide the mechanism necessary for fine-tuning PG signaling in a temporal and tissue-specific manner and offer a more efficacious chemotherapeutic site for the prevention/treatment of lung cancer. The balance between PGE synthase and L-PGDS, which incidentally has been described as a major determinant of other disease processes such as atherosclerosis, Cipollone F, Fazia M, Iezzi A, Ciabattoni G, Pini B, Cuccurullo C, et al. Balance between PGD synthase and PGE synthase is a major determinant of atherosclerotic plaque instability in humans. Arterioscler Thromb Vasc Biol 2004; 24:1259-65, also plays a significant role in lung cancer progression. [0124] Present studies indicate possible imbalanced expression of prostanoid receptors in colorectal cancer compared to normal colon tissue. Gustafsson A, Hansson E, Kressner U, Nordgren S, Andersson M, Lonnroth C, et al. Prostanoid receptor expression in colorectal cancer related to tumor stage, differentiation and progression. Acta Oncol 2007; 46:1107-12. L-PGDS or synthetic DP1 receptor agonists for its enzymatic product prostaglandin D 2 represent very attractive downstream sites for the prevention or treatment of lung cancer. L-PGDS may thus play a key role in modulating lung cancer growth and may offer a novel diagnostic and therapeutic approach for treatment. EXAMPLE 2 [0125] L-PGDS knockout mice were originally obtained from the Osaka Bioscience Institute (Osaka, Japan). Eguchi N, Minami T, Shirafuji N, Kanaoka Y, Tanaka T, Nagata A, Yoshida N, Urade Y, Ito S, Hayaishi O, “Lack of tactile pain (allodynia) in lipocalin-type prostaglandin D synthase-deficient mice”, Proc Natl Acad Sci USA 96:726-730 (1999). [0126] Transgenic L-PGDS overexpressors, were purchased from Jackson Laboratories (Bar Harbor, Me.). Hayaishi O, “Molecular genetic studies on sleep-wake regulation, with special emphasis on the prostaglandin D(2) system”, J Appl Physiol 92:863-868 (2002). [0127] Control C57BL/6 mice were purchased from Jackson Laboratories (Bar Harbor, Me.). [0128] Mice are maintained in temperature-controlled rooms (22° C.) with a 12 h light/dark cycle and given access to Rodent Lab Chow, #5001 (Purina, St. Louis, Mo.) and water ad libitum. Experiments are performed on 7-9 week old males housed 4 per cage, in plastic cages with hardwood bedding and dust covers following a 7-day quarantine. [0129] The efficacy of DP1/DP2 receptor agonists were tested, alone and in combination, on lung tumor formation in control and LPGDS KO mice in two separate experiments. The results of this investigation were inconclusive. While DP1 agonist may offer slight protection, the result was not reproducible within the experimental model employed. In addition the incubation conditions may need to be changed, for example, from 1 hr prior to tumor induction to several doses over the two week period. See, Wang J J, Mak O T, “Induction of apoptosis in non-small cell lung carcinoma A549 cells by PGD2 metabolite, 15d-PGD2”, Cell Biol Int. 2011 Apr. 21. [0130] In another experiment, shown in FIG. 10 , a mouse melanoma cell line was injected into three different strains of mice—Control C57BL/6, L-PGDS Knockouts, transgenic L-PGDS overexpressors. After 14 days the lungs were isolated and photographed. The L-PGDS overexpressors had low tumor count, while the L-PGDS Knockouts had a large visible number of tumors. The control C57BL/6 mice were intermediate. EXAMPLE 3 [0131] Another aspect of the invention provides a method for intra-tracheal gene therapy for lung cancer treatment. 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USA 85:3014-18 (1988); Wolff J A et al., “Direct Gene Transfer into Mouse Muscle in Vivo.” Science 247:1465-68 (1990); Wondisford F E et al., “Cloning of the Human Thyrotropin .beta.-Subunit Gene and Transient Expression of Biologically Active Human Thyrotropin after Gene Transfection.” Mol. Endocrinol. 2(1):32-39 (1988); Wu G Y and Wu C H, “Receptor-mediated Gene Delivery and Expression in Vivo.” J. Biol. Chem. 263(29):14621-14624 (1988); Anderson, W. F., “Human Gene Therapy,” Nature, 392:25-30 (Apr. 30, 1998); Nishikawa, M. et al., “Nonviral Vectors in the Millennium: Delivery Barriers in Gene Transfer,” Human Gene Therapy, 12:861-870 (2001); Rozenberg, Y. et al., “Alternative Gene Delivery,” S.T.P. Pharma Sciences,11:21-30 (2001); Balicki, D. et al., “Gene Therapy of Human Disease,” Medicine, 81:69-86 (2002); Orkin, S. H. and Motulsky, A. G., “Report and Recommendations of the Panel to Assess the NIH Investment in Research on Gene Therapy”, National Institutes of Health, 1-41 (Dec. 7, 1995); Verma, I. M. et al., “Gene Therapy-Promises, Problems and Prospects,” Nature, 389:239-242 (1997); Ross, G. et al., “Gene Therapy in the United States: A Five-Year Status Report,” Human Gene Therapy, 7:1781-1790 (1996); Marshall, E., “Gene Therapy's Growing Pains,” Science, 269:1050-1055 (1995); Gunzburg, W. H. and Salmons, B., “Virus Vector Design in Gene Therapy,” Mol. Med. Today 1(9) Abstract (December 1995); Goorecki, D. C., “Prospects and Problems of Gene Therapy: An Update,” Expert Opin. Emerging Drugs 6(2):187-198 (2001); Deonarain, M. P., “Ligand-Targeted Receptor-Mediated Vectors for Gene Delivery,” Exp. Opin. Ther. Patents 8(1):53-69 (January 1998); U.S. Pat. Nos. 3,687,808; 4,469,863; 4,476,301; 4,587,044; 4,605,735; 4,667,025; 4,762,779; 4,789,737; 4,816,567; 4,824,941; 4,828,979; 4,835,263; 4,845,205; 4,868,116; 4,876,335; 4,904,582; 4,948,882; 4,958,013; 4,980,286; 4,981,957; 5,013,830; 5,023,243; 5,034,506; 5,082,830; 5,109,124; 5,112,963; 5,118,800; 5,118,802; 5,130,302; 5,134,066; 5,138,045; 5,149,797; 5,166,315; 5,166,320; 5,175,273; 5,177,196; 5,185,444; 5,188,897; 5,194,599; 5,214,134; 5,214,136; 5,216,141; 5,218,105; 5,220,007; 5,223,409; 5,225,539; 5,235,033; 5,245,022; 5,254,469; 5,256,775; 5,258,506; 5,262,536; 5,264,423; 5,264,562; 5,264,564; 5,272,250; 5,276,019; 5,278,302; 5,286,717; 5,292,873; 5,317,098; 5,319,080; 5,321,131; 5,359,044; 5,366,878; 5,367,066; 5,371,241; 5,391,723; 5,393,878; 5,399,676; 5,403,711; 5,405,938; 5,405,939; 5,414,077; 5,416,203; 5,432,272; 5,434,257; 5,446,137; 5,451,463; 5,453,496; 5,455,233; 5,457,187; 5,459,255; 5,466,677; 5,466,786; 5,470,967; 5,476,925; 5,484,908; 5,486,603; 5,489,677; 5,491,133; 5,502,177; 5,510,475; 5,512,439; 5,512,667; 5,514,785; 5,519,126; 5,519,134; 5,525,465; 5,525,711; 5,527,899; 5,536,821; 5,539,082; 5,541,306; 5,541,307; 5,541,313; 5,545,730; 5,550,111; 5,552,538; 5,552,540; 5,561,225; 5,563,253; 5,565,332; 5,565,350; 5,565,552; 5,565,555; 5,567,810; 5,567,811; 5,571,799; 5,574,142; 5,576,427; 5,578,717; 5,578,718; 5,580,731; 5,585,481; 5,587,361; 5,587,371; 5,587,469; 5,591,584; 5,591,722; 5,594,121; 5,595,726; 5,596,086; 5,596,091; 5,597,696; 5,597,909; 5,599,923; 5,599,928; 5,602,240; 5,608,046; 5,610,289; 5,610,300; 5,614,617; 5,618,704; 5,623,065; 5,623,070; 5,625,050; 5,627,053; 5,633,360; 5,639,873; 5,645,985; 5,646,265; 5,646,269; 5,652,355; 5,652,356; 5,658,873; 5,663,312; 5,670,633; 5,672,697; 5,677,437; 5,677,439; 5,681,941; 5,688,941; 5,700,920; 5,700,922; 5,714,331; 5,719,262; 5,721,218; 5,733,743; 5,750,692; 5,763,588; 5,770,713; 5,792,608; 5,792,747; 5,830,653; 5,871,907; 6,005,096; 6,656,730; 7,195,916; US 2006/0019256, WO 86/01533; WO 87/02671; WO 89/02468; WO 89/05345; WO 89/07136; WO 90/02809; WO 91/17271; WO 92/01047; WO 92/07573; WO 92/09690; WO 92/15679; WO 92/18619; WO 92/20791; WO 93/01288; WO 93/07883; WO 93/24510; WO 94/02610, each of which is expressly incorporated herein by reference. [0132] According to another embodiment, a live bacterial vector, preferably a tumor targeting bacteria, such as Salmonella typhimurium VNP20009 (TAPET), is used to deliver an RNA or DNA construct, or an expressed gene product, such as L-PGDS, in or in proximity to, the tumor. For example, see U.S. Pat. Nos. 7,514,089; 7,452,531; 7,354,592; 6,962,696; 6,923,972; 6,863,894; 6,685,935; 6,475,482; 6,447,784; 6,190,657; 6,080,849; 2009/0175829; 2009/0053186; 2009/0028842; 2005/0026866; 2004/0202663 each of which is expressly incorporated herein by reference. See also, Chen G, Wei D P, Jia L J, Tang B, Shu L, Zhang K, Xu Y, Gao J, Huang X F, Jiang W H, Hu Q G, Huang Y, Wu Q, Sun Z H, Zhang J F, Hua Z C, “Oral delivery of tumor-targeting Salmonella exhibits promising therapeutic efficacy and low toxicity” Cancer Science, 100(12):2437-2443, December 2009. [0133] According to a further aspect of the invention, pharmacological agents which target DP1 and/or DP2 are provided for the treatment of lung cancer. [0134] L-PGDS transgenic overexpressors are relatively resistant to carcinogen-induced lung tumor formation and/or require a higher dose of carcinogen to elicit the same number of tumors per mouse than control. L-PGDS knockout mice to have increased tumor multiplicity and a high sensitivity to carcinogen-induced lung tumor formation. [0135] DP1/DP2 agonists may provide protection against carcinogen-induced lung tumors or result in decreased tumor progression. [0136] L-PGDS effects are modulated by its enzymatic product PGD 2 and it is believed to be the DP1 receptor responsible for the control of tumor growth. It is however possible downstream PGD 2 -derivatives, working via PPARγ interaction, are also involved. Studies using PPARγ agonists (15-dPGJ 2 ) as well as antagonists (LG100641) help confirm or rule out the involvement of signal transduction from PPARγ activation. Signaling studies permit defining a role for PKC, either acting alone or synergistically with p38MAPK, mediating L-PGDS-induced apoptosis. In addition, PI3-K may contribute to this process. [0137] L-PGDS or synthetic receptor agonists (or other receptor-active drugs) for its enzymatic product prostaglandin D 2 , have an enormous potential to positively impact lung tumor prevention/treatment. Given the relatively easy accessibility of the lung, L-PGDS gene therapy is also a viable option in the treatment of lung cancer.

A PGD(2) receptor (DP) deficiency enhances tumor progression accompanied by abnormal vascular expansion. In tumors, angiogenic endothelial cells highly express DP receptor, and its deficiency accelerates vascular leakage and angiogenesis. Administration of a synthetic DP agonist, BW245C, markedly suppresses tumor growth as well as tumor hyperpermeability in WT mice, but not in DP-deficient mice. In a corneal angiogenesis assay and a modified Miles assay, host DP deficiency potentiates angiogenesis and vascular hyperpermeability under COX-2-active situation, whereas exogenous administration of BW245C strongly inhibits both angiogenic properties in WT mice. In an in vitro assay, BW245C does not affect endothelial migration and tube formation, processes that are necessary for angiogenesis; however, it strongly improves endothelial barrier function via an increase in intracellular cAMP production. PGD(2)/DP receptor is a newly identified regulator of tumor vascular permeability, indicating DP agonism can be exploited as a therapy for the treatment of cancer.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] Not Applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable. MICROFICHE APPENDIX [0003] Not Applicable BACKGROUND OF THE INVENTION [0004] 1. Field of the Invention [0005] This invention relates to the field of fishing equipment. More specifically, the invention comprises a molded fish attractant which can be easily attached to a fishing line. [0006] 2. Description of the Related Art [0007] Artificial baits have been in common use for many years. One such device is illustrated in FIG. 1. Artificial lure 10 is shaped to mimic the action of a bait fish as it is pulled through the water. Fishing line 14 is typically connected on one end to a fishing rod. The other end is tied to the leading portion of swivel 16 . The trailing portion of swivel 16 is tied to a second much shorter piece of fishing line, denoted leader 18 . [0008] Leader 18 is typically quite short, extending as little as 12 to 24 inches. It is often made from heavier gage line than fishing line 14 , so that it can withstand a bite or other rough treatment in close proximity to the fish sought. In some case, leader 18 may even be made of steel wire. Leader 18 is attached to artificial lure 10 at attachment ring 18 . A number of hooks 12 extend outward from artificial lure 10 . [0009] [0009]FIG. 2 illustrates a second type of prior art artificial bait—worm 20 . Worm 20 is typically molded from a pliable plastic or rubber. An offset hook 22 is inserted through worm 20 , leaving hook ring 24 protruding out the forward portion. Leader 18 is then tied or otherwise attached to hook ring 24 . [0010] Th use of scent-type attractants is also known in the prior art. These formulations, such as fish oil, have been inserted into a reservoir within worm 20 , where they leak out through a small orifice. Fish oil reservoirs have also been provided within artificial lures such as the one depicted in FIG. 1. BRIEF SUMMARY OF THE INVENTION [0011] A fish attractant slug which can be easily placed on a fishing line in close proximity to a bait. The slug includes a center bore and an outside surface. The outside surface opens into a spiral groove which connects with the center bore. In order to install the device, the user wraps the fishing line around the spiral groove, then pulls it taut. The tension placed on the fishing line pulls the line inward until it rests within the center bore. [0012] In use, the attractant slug slowly dissolves to release the fish attractant it contains. The installation method means that a replacement attractant slug can be placed on the fishing line without untying the bait. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0013] [0013]FIG. 1 is an isometric view, showing a prior art artificial lure. [0014] [0014]FIG. 2 is an isometric view, showing a prior art worm. [0015] [0015]FIG. 3 is an isometric view, showing the present invention. [0016] [0016]FIG. 4 is an isometric view, showing the installation of the present invention. [0017] [0017]FIG. 5 is an isometric view, showing the installation of the present invention. [0018] [0018]FIG. 6 is an isometric view, showing the installation of the present invention. [0019] [0019]FIG. 7 is an isometric view, showing the installation of the present invention. [0020] [0020]FIG. 8 is an isometric view, showing the present invention installed on an artificial lure. [0021] [0021]FIG. 9 is an isometric view, showing the present invention installed on a worm. REFERENCE NUMERALS IN THE DRAWINGS [0022] [0022] 10 artificial lure 12 hook [0023] [0023] 14 fishing line 16 swivel [0024] [0024] 18 leader 20 worm [0025] [0025] 22 offset hook 24 hook ring [0026] [0026] 26 attractant slug 28 body [0027] [0027] 30 center bore 32 spiral groove [0028] [0028] 34 entry slot 36 exit slot [0029] [0029] 38 attachment ring DESCRIPTION OF THE INVENTION [0030] present invention is an attachable fish attractant which slowly disperses the attracting ingredients into the water during use. FIG. 3 depicts attractant slug 26 . It is formed as body 28 , have a central bore 30 running from its upper extreme to its lower extreme. The outer surface is formed in a smooth, hydrodynamic shape. Spiral groove 32 is cut into the outer surface. The inner portion of spiral groove 32 opens into central bore 30 . The upper extreme (in the view as shown) of spiral groove 32 terminates in entry slot 34 , with the lower extreme terminating in exit slot 36 . [0031] In use, attractant slug 26 will preferably be placed in close proximity to the bait. The ideal location is immediately ahead of the bait, attached to leader 28 . Attractant slug 26 is made of a material which slowly dissolves in water. Thus, after a short period of use, attractant slug 26 will dissolve and need to be replaced. It is obviously desirable to be able to replace attractant slug 26 without having to detach the bait from the leader. Spiral groove 32 is provided for this purpose, as will be explained in the following. [0032] [0032]FIGS. 4 through 7 show the sequence of placing attractant slug 26 on leader 28 (or any other type of fishing line). Throughout the following descriptions, those skilled in the art will realize that the use of leader 18 is optional. In many applications, fishing line 14 will be directly attached to the lure without the use of a leader. Thus, for purposes of attaching the invention, a leader or a fishing line are interchangeable. [0033] In FIG. 4, leader 28 has been passed through entry slot 34 and into the leading portion of spiral groove 32 . The user then wraps leader 28 around spiral groove 32 , as shown in FIG. 5. In FIG. 6, leader 28 has been wrapped completely around spiral groove 32 , so that a portion of leader 28 lies entirely within spiral groove 32 . At this point, the user pulls on the free ends of leader 28 to place tension on the portion lying within spiral groove 32 . This action results in leader 28 being drawn down into center bore 30 , as shown in FIG. 7. Once leader 28 has been drawn into center bore 30 , it will not tend to reenter spiral groove 32 . Thus, attractant slug 26 is securely fastened to leader 28 . [0034] Once in the state shown in FIG. 7, attractant slug 26 is free to move back and forth on leader 28 . It may then be pushed along leader 28 until it comes up against the bait. As the bait is then dragged through the water, hydrodynamic forces will tend to keep attractant slug 26 positioned immediately ahead of the bait, where it will slowly dissolve and release the attractant materials over the bait. [0035] [0035]FIG. 8 shows attractant slug 26 in position in front of artificial lure 10 . FIG. 9 shows attractant slug 26 in position in front of worm 20 . Of course, as those skilled in the art will know, attractant slug 26 could just as easily be placed in front of a natural bait, such as a shrimp or a cigar minnow. The reader will appreciate that what was denoted as the upper extreme of attractant slug 26 in FIG. 3 is more aptly referred to as the leading extreme in FIGS. 8 and 9 (with respect to the direction of towing the bait). Likewise, what was denoted as the lower extreme in FIG. 3 is more appropriately referred to as the trailing extreme in FIGS. 8 and 9. [0036] Returning now to FIG. 3, those skilled in the art will also realize that the diameter of center bore 30 can be increased substantially without affecting the operation of the device. Looking at FIG. 1, the enlargement of center bore 30 allows attractant slug 26 to pass over swivel 16 . This feature is important for the following reason: When a lure is towed in a trolling fashion, it may be 50 yards or more behind the boat. In order to replace a conventional attractant, the lure must be reeled in, serviced, and allowed to trail back out to its original position (a time consuming process). Using the present invention—with an appropriately sized center bore 30 —the user simply places attractant slug 26 on fishing line 14 near the point where it attaches to the fishing rod. Gravity (sometimes with help from the user) cause attractant slug 26 to slide down the line and into the water. Once attractant slug 26 is in the water, hydrodynamic forces slide it aft along the fishing line until it comes to rest against the front of the bait. Thus, the user can replace the attractant slug, or add additional attractant slugs, without interrupting the trolling. [0037] Returning now to FIG. 3, those skilled in the art will realize that the interaction of spiral groove 32 and center bore 30 , allows the convenient installation of attractant slug 26 on virtually any type of flexible line. Those skilled in the art will realize, however, that the helical form of spiral groove 32 illustrated is not the only shape that can perform this function. The key is to provide a slot connecting the outer surface of attractant slug 26 with center bore 30 , which is sufficiently curved (non-straight) to require the fishing line to be manipulated into a curved shape in order to enter center bore 30 . In use, the fishing line is maintained in tension. Thus, it is unlikely that it will lapse into a curved shape which would allow it to escape center bore 30 . [0038] A simple crescent shape can be substituted for spiral groove 32 . Additional shapes include a zig-zag, an S-curve, and a chevron. However, as best seen in FIG. 5, the use of the helical shape allows the user to naturally wrap the fishing line into spiral groove 32 . This is true because persons familiar with fishing equipment are accustomed to wrapping line around a spool. Thus, the helical shape constitutes the preferred embodiment. [0039] The material selected for attractant slug 26 is obviously important. The method of mounting attractant slug 26 on the fishing line allows the use of rigid and substantially rigid materials. However, the material must also slowly dissolve in water in a controllable fashion. One particularly suitable compound is a moldable gelatin in which the fish attractant is dissolved or suspended. Polyglycols can be used as well. Additional specific examples of effective materials include polyglycol 1450, polyglycol 3350, acacia gum, sorbitol, pectin, and starch. [0040] The desired scent is then blended with the gelatin while it is still in the liquid state. The liquid is then injected into a cavity mold and allowed to solidify. In this fashion, the shape depicted in FIG. 3 can be molded as one integral unit. [0041] The external profile of attractant slug 26 can affect how it behaves in the water, as well as the rate at which the material dissolves. The bullet shape shown tends to cause turbulent flow near the trailing extreme of the material, which can promote dispersion of the attractant. Ifa slower dispersion rate is desired, a spherical or teardrop shape can be employed. Those skilled in the art will realize that an endless variety of external shapes are possible. [0042] The actual type of fish attracting agent used is not critical to the present invention. Many different types of attracting agent are well known in the prior art. Examples include meal made of ground and dried squid, shrimp, sardines, bunker, or other bait fishes. Waste materials normally discarded by the canning industry (such as heads, guts, etc.) are also often used. Artificial chemicals can be employed as well. Additional suitable fish attractants include Menhaden, Shrimp, Pogie, Cigar minnow, Squid, Crayfish, Bluegill, Shad, Spanish Sardine, Boston Mackerel, Bonita, Northern Mackerel, Scallop, Mullet, Garlic, and Salt. [0043] Other materials can be added to the invention as well. As one example, bright colors and microglitter are often employed to attract fish. Fish feeding on natural baits often produce an explosion of reflective scales in the water. The addition of microglitter to the attractant slug causes a release of bright particles as the slug dissolves, which mimics this natural phenomenon. [0044] The preceding description contains significant detail regarding the novel aspects of the present invention. It should not be construed, however, as limiting the scope of the invention but rather as providing illustrations of the preferred embodiments of the invention. Thus, the scope of the invention should be fixed by the following claims, rather than by the examples given.

A fish attractant slug which can be easily placed on a fishing line in close proximity to a bait. The slug includes a center bore and an outside surface. The outside surface opens into a spiral groove which connects with the center bore. In order to install the device, the user wraps the fishing line around the spiral groove, then pulls it taut. The tension placed on the fishing line pulls the line inward until it rests within the center bore. In use, the attractant slug slowly dissolves to release the fish attractant it contains. The installation method means that a replacement attractant slug can be placed on the fishing line without untying the bait.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention generally relates to a crop processor in the form of an attachment to a round hay baler for cutting, chopping and shredding various crops, especially hay and all types of crops with stems or stalks extending above ground. The cut, chopped or shredded crop is discharged into a round hay baler to form the processed crop into a round hay bale with the cut lengths of the crop material being useful for bedding, dry feeds, silage and other wet feeds and is especially useful in a total mixed ration mixing machine. The crop processor includes an open bottom housing having a high speed rotor with multiple knives mounted thereon. An adjustable shear bar is mounted in the housing to enable the crop to be processed to be cut at desired cut length by the knives on the spinning rotor as they pass the shear bar. The housing is located generally under the hitch area and forwardly of the existing wheels, hay entrance area and pickup tines of the round bale hay baler with the processed crop material being delivered to the round hay baler in the same location that hay would normally enter the baler to be baled. The shear bar is horizontally adjustable toward and away from the rotor and knives to vary the cutting, chopping and shredding characteristics of the crop processor in order to vary the cut length of crop material. The rotor is driven by a drive system which includes a forwardly positioned hitch extension and a gear box oriented forwardly of the baler drive system. The gear box is driven by the existing power takeoff shaft from a towing tractor. The hay baler is also driven from the gear box. The gear box drives an output shaft which is drivingly connected to the rotor through a chain coupler, PTO shaft and belt and pulley assemblies. The crop processor is supported from the hay baler to enable the apparatus to float upwardly when traversing uneven terrain such as through dips, small ditches, gopher mounds and the like with the apparatus returning to its normal cutting height due to gravity when traversing level terrain. The rotor is in the form of square tube with the pivotal knives being mounted on the flat side surfaces of the tube in staggered relation. 2. Description of the Prior Art Shredding devices are well known for shredding stubble or stalks from a harvested crop. Such devices usually deposit the shredded material back onto the ground surface which would require a raking or pickup operation to collect and make use of the shredded material. Shredding devices also exist which discharge the shredded material into the baler to form bales of shredded material. Such devices are in the form of attachments to hay balers including hay balers which produce generally rectangular bales as well as hay balers which produce round hay bales. The following U.S. Patent Nos. relate to this subject matter. U.S. Pat. Nos: 2,817,945 3,295,299 3,362,144 3,483,688 3,604,188 3,606,748 3,641,754 3,894,484 4,280,320 4,559,770 5,052,170 The above listed prior patents do not disclose the crop processor for round hay balers of the present invention. SUMMARY OF THE INVENTION An object of the present invention is to provide a crop processor for a round hay baler mounted forwardly of the existing wheels, hay entrance area and pickup tines of a round hay baler with the crop processor including an open bottom housing having a driven rotor oriented horizontally within the housing and including a plurality of longitudinally and circumferentially spaced pivotal knives mounted thereon which are associated with a horizontally disposed shear bar to cut, chop and shred hay, various stem crops and stubble projecting upwardly from the ground surface being traversed with the processed crop material being discharged toward the existing hay entrance area and pickup tines of the round hay baler to form a round bale from the crop material. Another object of the invention is to provide a crop processor in accordance with the preceding object in which the shear bar is adjustable toward and away from the axis of rotation of the rotor and the knives thereon to vary the cut length of the crop material. A further object of the invention is to provide a crop processor oriented below the hitch and PTO drive shaft from a tractor to a round hay baler with the rotor of the crop processor being driven from a gear box incorporated into the PTO shaft between the tractor and round hay baler with the existing hitch being provided with a hitch extension which is connected to the existing hitch and connected to the tractor drawbar. Still another object of the invention is to provide a crop processor for round hay balers as set forth in the preceding objects in which the gear box is drivingly connected to the rotor through a PTO shaft and belt drive system. A still further object of the invention is to provide a crop processor in which the rotor is a square tube provided with removable ends with a central shaft extending axially from each end for supporting the rotor. The removable ends enable the shaft to be more easily removed or replaced. Another significant object of the invention is to provide a crop processor for round hay balers supported from the hay baler for floating movement to facilitate traversal of uneven terrain. An additional significant object of the invention is to provide a crop processor for processing hay, especially alfalfa, other stem crops, stubble and the like in which the cut length of the crop material can be adjusted and discharged into the baler to form a round hay bale for use as bedding, dry feeds, silage and wet feeds including use in total mixed ration (TMR) blending machines which can eliminate the tub grind process for round hay bales. 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 side elevational view of the crop processor of the present invention illustrating its association with a round hay baler. FIG. 2 is a front perspective view of the crop processor and round hay baler with portions of the drive system enclosures being shown in open position for illustrating the drive system for the rotor of the crop processor. FIG. 3 is a detailed side view of the crop processor including a forward hitch extension and its association with a tractor and round hay baler from the side opposite to that of FIG. 1. FIG. 4 is an enlarged side elevational view, with portions shown in section, illustrating further structural details of the crop processor and the drive mechanism. FIG. 5 is a longitudinal sectional view of the crop processor housing, rotor with knives and shear bar. FIG. 6 is a transverse, sectional view taken along section line 6--6 on FIG. 1 illustrating further structural details of the drive mechanism for the crop processor rotor. FIG. 7 is a transverse, sectional view taken along section line 7--7 on FIG. 4 illustrating further structural details of the crop processor. FIG. 8 is a perspective view of the shear bar illustrating the slots which enable adjustment of the shear bar. FIG. 9 is a side elevational view of the rotor. FIG. 10 is a transverse sectional view, on an enlarged scale, taken along section line 10--10 on FIG. 9. FIG. 11 is a fragmental sectional view showing the association of the rotor and shaft. DESCRIPTION OF THE PREFERRED EMBODIMENT The crop processor of the present invention is generally designated by reference numeral 10 and is illustrated in combination with a round hay baler 12 with the crop processor being supported below the forward end portion of the hay baler, below the rearward end of the hitch and drive assembly 14 for the hay baler 12 and forwardly of the rear axle 16 and wheels 18 of the hay baler and forwardly of the existing hay entrance area and pickup tines and the front wheels 19 of the hay baler. The hay baler 12 is connected to a conventional tractor 20 through the hitch and drive assembly 14 which includes the existing hitch 22 and a forwardly extending hitch extension 27 connected to a draw bar 24 on the tractor through a clevis and bolt or pin 26 at the forward end of the hitch extension 27. The hitch and drive assembly 14 also includes a conventional PTO shaft 28 driven from the tractor 20 in a conventional and well known manner. The crop processor 10 is associated with a round hay baler 12 substantially of conventional construction, although slightly modified. As illustrated, the crop processor can be associated with a John Deere round hay baler such as Model Nos. 535, 435, 375 and 335. The crop processor may also be used with other types of round hay balers which are commercially available. The crop processor 10 includes a transversely extending housing 30 including an arcuate top wall 32, end walls 34, an open bottom 36 and a forwardly projecting nose portion 38 having a transversely extending horizontal narrow wall 40 which supports a shear bar 42 against the undersurface thereof as illustrated in FIG. 5. As illustrated in FIG. 7, the shear bar 42 is an elongated metal knife blade having an inclined or beveled upper corner on the rearward edge 44 and a plurality of elongated slots 46 having a major axis parallel to the end edges of the shear bar 42. The elongated slots receive mounting bolts 48 which extend up through the slots 46 in bar 42, through the wall 40 and threaded into an anchor bar 49 which engages the upper surface of wall 40. This enables the shear bar 42 to be moved toward and away from a transverse rotor generally designated by reference numeral 50 which is positioned in the housing rearwardly of the shear bar 42 and rearwardly of the arcuate top wall 32 which extends down to and joins with the narrow bottom wall 40. The rotor 50 includes an elongated square tube 52 extending transversely of the housing 10. Each of the four side surfaces of the square tube 52 is provided with a plurality of longitudinally spaced pair of lugs 54 extending perpendicularly from the surface of one of the side walls of the square tube 52. Each pair of lugs 54 supports a pivotal knife 56 by a pivot bolt 58 which detachably supports the knife 56 from the lug 54 and enables removal and replacement thereof as necessary. While a square tube 52 has been disclosed, the rotor 50 can be a solid shaft and can be cylindrical, a multisided polygon or other configurations which can be rotated at relatively high speed about the longitudinal axis. Each of the knives 56 are of generally Y-shaped configuration with the outer end portions 60 being outwardly curved as illustrated in FIG. 6. Also, the peripheral edge of each blade is inclined or beveled at 62. The knife configuration disclosed is generally referred to as a side slicing knife. However, other knife configurations can be used such as knives which are T-shaped, L-shaped, J-shaped, cupped or the like. Also, the knife spacing on the rotor can be varied. The rotor 50 rotates in a counterclockwise direction as indicated by the directional arrow in FIG. 5. The rotational axis of the rotor 50 is the center axis of the square tube 52. The outer end of the knives 56 pass close to the downwardly facing surface of the arcuate wall 32 and close to the beveled edge 44 of the shear bar 42 to cut the crop material. Adjustment of shear bar 42 enables the cut length of the crop material being processed to be varied. The processed crop material is discharged through an outlet 63 in the rear of the housing in front of and forwardly of the existing hay entrance area and pickup tines on the baler. As illustrated in FIGS. 9-11, the square tube 52 of the rotor 50 is supported by a shaft 64 centrally connected to each end of the tube 52 by a flange plate 66 bolted to an end flange 67 rigid with tube 52 and keyed to shaft 64. This drive arrangement enables easy replacement of the shaft 64 and repair or replacement of the rotor. The shaft 64 may extend completely through the tube 52 and can be keyed directly to the end plate 67 on tube 52 or be in the form of axially extending stub shafts. In any event, the shaft is supported on the side walls 36 by outboard bearing structures 68 bolted to the side walls. Each side wall includes a notch or slot 70 extending to the lower edge of the side wall with the notch 70 being closed by a retaining plate 72 to enable assembly and disassembly of the rotor with respect to the housing. The knives 56 are limited in one direction of pivotal movement by stop members 74 rigid with the inner ends of the lugs 54 in the direction of rotation of the knives as illustrated in FIG. 5. The lower edge of the side walls at the forward end are upwardly slanted as at 76 and include a skid shoe 78 attached thereto by a bracket structure 80 to engage uneven terrain to assure that the periphery of the path of movement of the knives 56 is maintained at a generally constant distance above the ground surface. At the front of the housing 30, a plurality of depending swing flaps or panels 82 are supported from a bracket structure 84 at the forward end of the nose portion 38 of the housing. The bracket structure 84 enables the panels or flaps 82 to pivot about a generally horizontal axis at their upper ends to enable the panels to swing rearwardly for admitting crop material to enter the crop processor. One end of the shaft 64 for the rotor 50 is provided with a belt pulley 86 on the end thereof which is contained within a housing 88 with a drive belt or belts 90 extending forwardly from the pulley 86 and encircling a pulley 92 at the forward end of the housing 88. To provide access to the drive belt or belts 90, the upper wall of the housing 88 is provided with a laterally, pivotal cover plate 94 which provides access to the drive belt or belts for the rotor. The pulley 92 is connected to a transversely extending telescopic PTO shaft 96 through a drive slip clutch mechanism 98 which is oriented within a housing 100 provided with a pivotal, curved access door 102. The PTO shaft 96 extends transversely and downwardly under the hitch into a housing 104 on the opposite side of the hitch. A belt pulley 106 is oriented in housing 104 and is connected to the PTO shaft 96. The upper end of the housing 104 is provided with a pulley 108 in alignment with the pulley 106 with a drive belt 110 being used to transmit driving torque to the PTO shaft 96. The pulley 108 is driven from a gear box 112 mounted on the hitch and incorporated into the PTO shaft 28. A chain-type coupling 114 connects an output shaft 118 from the gear box 112 to a supporting shaft 116 for the pulley 108 in the housing 104. As illustrated in FIG. 4, the PTO shaft 28 inputs into the gear box 112 and the gear box includes the output shaft 118 which extends to the chain coupler 114 and an output shaft 120 to drive the baler. The coupler 114 connects the output shaft 118 to the input shaft 116 to the pulley 108 which drives the belt or belts 110 to the pulley 106 which is connected to the transverse PTO shaft 96. The gear box also includes a rearwardly extending PTO shaft 120 which connects to the drive mechanism of the round hay baler through a slip clutch 122 and universal joint 123. As illustrated in FIG. 2, the components of the PTO shaft 28 and 120 and clutch 122 are covered by pivotal guards 124 and 126 and the chain coupler 114 is covered by a pivotal guard plate 115. The hitch extension 27 is approximately two feet long. The extension length provides the necessary space to keep the tractor wheels away from the drive system and enables the use of the existing PTO drive line. The hitch extension 27 bolts onto the existing baler hitch 22 through the existing hitch pin hole at 132 and is braced by a channel member 134 which bridges the juncture between the hitch extension 27 and existing hitch 22. The drive structure including the housing 104 is protected by a plate 135 which extends under the hitch assembly and drive mechanism to form the crop material, stalks and the like into windrows as they enter the crop processor and for shielding the drive system. The rotor speed defined by the knife tip speed is selected for the particular crop material and the condition of the crop material. For dry cornstalks, a tip speed of about 60 MPH is adequate. A faster tip speed, about 115 MPH, is necessary for stem crops and damp or wet silage. Higher tip speeds may be found to be effective for certain crop materials and conditions of the crop material. The crop processor is supported pivotally at its rearward end by rearwardly extending brackets 136 attached to depending brackets 138 on the round hay baler by a pivot bolt 140. The forward end portion of the housing is supported by upwardly extending support members 142 and 144 which allows the crop processor to float. The structure 144 is a height adjusting jack and the right height adjuster 142 determines the maximum free travel upwards and downwards which allows the processor to float up and down when traversing uneven terrain with gravity causing the front end portion of the processor to return down to normal cutting height when traversing smooth terrain. The gear box and belt drive arrangement is protectively covered by guards and the two drive belts are Gates Poly Chain or an equivalent drive belt. The PTO drive shaft 28 is used but it is connected to the gear box 112 as an input through a universal joint 29. The output shaft 120 is connected to the slip clutch 122 on the baler through a set of double universal joints 123. The gear box 112 increases the speed and is coupled to the belt drive system 108, 110, 106 and shaft 96 through the conventional chain coupler 114. The PTO shaft 96 extends to the drive pulley 92 which drives the belt 90 and pulley 86 thus driving the rotor 50 at a higher rotational speed than the input from the PTO shaft 28. The unique incorporation of a gear box with outputs for driving the crop processor and hay baler enables the same PTO shaft to be used as was normally used to drive the hay baler. The floating support structure and adjustable shear bar enhance the operational characteristics of the crop processor and enable variation in the cut length of the crop material produced by the processor. The hay baler and/or the rotor can also be driven by a hydraulic drive system in which the hydraulic pump, fluid supply and hoses can be mounted on the baler or a towing tractor. The drive system could also use a single heavy duty gearbox to drive the baler and crop processor and the crop processor can be mounted on a self propelled baler and be driven by a positive drive systems or a hydraulic drive system. The drive system can use belts and pulleys as disclosed but also can use various positive drive systems including chains and sprocket gears, gearboxes, drive shafts and various combinations of existing positive drive components. The foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and, accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

A crop processor for attachment to a round hay baler for cutting, chopping and shredding various crops, especially hay and all types of crops with stems or stalks extending above ground with the cut, chopped or shredded crop being discharged into a round hay baler to form the processed crop into a round hay bale with the cut lengths of the crop material being useful for bedding, dry feeds, silage and other wet feeds and is especially useful in a total mixed ration mixing machine. The crop processor includes a high speed rotor with multiple cutting elements mounted thereon associated with a shear bar. The rotor and shear bar are oriented in a housing having an open bottom to enable a crop to be engaged and cut by the rotor and shear bar. The shear bar is horizontally adjustable toward and away from the rotor and cutting elements to vary the cutting, chopping and shredding characteristics of the crop processor in order to vary the cut length of crop material.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 62/180,953 filed on Jun. 17, 2015, which is incorporated by reference herein in its entirety. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] This invention was made with government support under IOS1256664 awarded by the National Science Foundation. The government has certain rights in the invention. BACKGROUND [0003] This application relates to chitooligosaccharides that lack a lipid moiety, and to methods of using such chitooligosaccharides to promote growth and/or development of non-leguminous plants. [0004] Plants associate with a wide range of microorganisms that facilitate the acquisition of nutrients and protect them against biotic and abiotic stresses. For example, interactions with arbuscular mycorrhizal (AM) fungi are widespread in land plants, and this association aids in the uptake of nutrients from the soil (Harrison, M. J. (2005), Annu. Rev. Microbiol. 59: 19-42). Because AM fungi are obligate symbionts, little is known about the molecular and genetic basis of this symbiosis. [0005] Much of what is known about AM fungi/plant symbiosis has come from studies of the symbiotic association between plants and nitrogen-fixing rhizobium bacteria, which most notably results in the formation of nitrogen-fixing nodules. Unlike the association between AM fungi and plants, the rhizobium bacteria symbiosis is restricted to specific groups of plants, primarily legumes (Soltis, D. E., et al. (1995), Proc. Natl. Acad. Sci. USA 92: 2647-2651). However, both interactions are similar in that they require chemical communication facilitated by the production of diffusible signals by the symbiont (Oldroyd, G. E. (2013), Nat. Rev. Microbiol. 11: 252-263). [0006] Rhizobial bacteria signal to legumes with Nod factors, which are lipochitooligosaccharides (LCOs) containing a chitin backbone substituted with a lipid moiety, an N-acyl group, and a number of additional groups that vary between Nod factors produced by different species of rhizobia (Dénarié, J. et al. (1996), Annu. Rev. Biochem. 65: 503-535). Nod factor perception utilizes a signalling pathway that is also involved in the establishment of mycorrhizal associations (Oldroyd, G. E. (2013)). [0007] AM fungi also produce diffusible signals that are recognized by the host plant via the common symbiosis signalling pathway. Research suggests that at least two different mycorrhizal signals are active on Medicago truncatula (Chabaud, M., et al. (2011), New Phytol. 189: 347-355). Similarly, work in rice ( Oryza sativa ) demonstrates mycorrhizal signalling that is both dependent and independent of the common symbiosis signalling pathway (Gutjahr, C., et al. (2008), Plant Cell 20: 2989-3005). [0008] The AM fungus Rhizophagus irregularis produces LCOs (Maillet, F., et al. (2011), Nature 469: 58-63), some of which are sulfated, resulting in a structure very similar to the Nod factor produced by Sinorhizobium meliloti , the symbiont of M. truncatula . These Myc-LCOs activate responses in M. truncatula similar to those activated by Nod factor, including the promotion of lateral root outgrowth. Consistent with these findings, U.S. Patent Publication No. 2011/0301032 discloses a method of stimulating a plant by contacting the plant with Myc-LCOs and variants thereof, wherein the variants all retain a lipid moiety. [0009] The lipid moieties incorporated into the LCOs disclosed by, e.g., U.S. Patent Publication No. 2011/0301032, make it difficult and/or expensive to synthesize large quantities of such compounds from commonly available chitooligosaccharide source materials. Furthermore, the lipid moieties decrease the solubility of such compounds in water, increasing the challenges associated with dissolving the compounds in aqueous solutions for scaled up application to seeds, seedlings, or plants. Accordingly, there is a need in the art for alternate compositions and methods for stimulating plant growth and/or development that do not have these disadvantages in large-scale applications. BRIEF SUMMARY [0010] In addition to LCOs, AM fungi produce short-chain chitooligosaccharides lacking a lipid moiety (COs), such as CO4 and CO5, that may be involved in AM/plant interactions (Genre, A., et al. (2013), New Phytol. 198: 190-202). Furthermore, longer chain COs, such as CO8, are known to function as pathogenic signals that stimulate plant defenses. The inventors disclose herein that both shorter and longer chain COs can be used to promote the growth and/or development of non-leguminous plants, including, without limitation, of cereal grains, such as rice, wheat or corn (maize). [0011] The term “non-leguminous plant” refers to plant species that are not classified as legumes. It is well-known in the art as to which plant species are legumes. The term “cereal grain” refers to a grass that is cultivated as a crop for the edible components of its grain (a type of fruit known in the art as a caryopsis). [0012] Accordingly, in a first aspect, this disclosure encompasses a method for stimulating the growth of a non-leguminous plant. The method includes the step of contacting a non-leguminous plant, a part thereof, or a seedling or seed thereof with a composition that includes a chitooligosaccharide (CO) having the formula: [0000] [0000] where n is 0, 1, 2, 3, 4, 5, or 6; R1 is —H, —CH 3 , —COCH 3 , —SO 3 H, —SO 3 Na, arabinose, methylated arabinose, fucose, or methylated fucose; R2 is —H, —CH 3 , —COCH 3 , —SO 3 H, —SO 3 Na, arabinose, methylated arabinose, fucose, or methylated fucose; and each R3 is independently —H or —COCH 3 . As a result of practicing the method, the growth of the plant is stimulated. [0013] “Stimulated” plant growth means that the quantity, weight and/or size of one or more parts of the plant is increased, relative to a plant where the seed, seedling, plant, or plant part has not been contacted with the composition that includes the CO. Such increased quantity, size or mass may include, but is not limited to, increased length of the root system, increased number of crown roots, increased number of lateral roots, increased dry weight, increased shoot length, or some combination of these. Such plant growth stimulation can have some beneficial effects on the plant, including, without limitation, enhancing soil nutrient acquisition, facilitating the establishment of young plants in the field, and increasing crop plant yield. [0014] In some embodiments, the composition is contacted with one or more leaf and/or root surfaces of the non-leguminous plant. In some such embodiments, the composition further comprises a surfactant. A “surfactant,” also known as a “wetting agent,” is a substance that is capable of reducing the surface tension of a liquid composition. [0015] In some embodiments, the composition is contacted with a seedling, seedling part or seed of the non-leguminous plant. In some such embodiments, the seedling, seedling part or seed of the non-leguminous plant is submerged in and subsequently removed from the composition. In some embodiments, the seedling part may include plant foliage or plant roots. [0016] In some embodiments, the composition is contacted with the plant, plant part, seedling or seed for about 1 hour to about 96 hours. In some such embodiments, the composition is contacted with the plant, plant part, seedling or seed for about 6 hours to about 48 hours. [0017] In some embodiments, the concentration of the CO in the composition is within the range of about 10 −3 M to about 10 −10 M. In some such embodiments, the concentration of the CO in the composition is within the range of about 10 −3 M to about 10 −9 M. In some such embodiments, the concentration of the CO in the composition is within the range of about 10 −3 M to about 10 −8 M. [0018] In some embodiments, the composition further includes water and alcohol. The alcohol acts to increase the solubility of the CO in the aqueous composition. In some such embodiments, the alcohol is ethanol. [0019] In some embodiments, the non-leguminous plant is a monocotyledon. In some such embodiments, the monocotyledon is a cereal grain. Non-limiting examples of cereal grains that can be used with the method include rice, wheat and corn (maize). [0020] In some embodiments, R1 is —H, R2 is —H, and each R3 is —COCH 3 . In some such embodiments, n is 2 (the compound is tetra-N-acetylchitotetraose, CO4) or 6 (the compound is octa-N-acetyl-chitooctaose, CO8). [0021] Other features of the disclosed methods will become apparent from a review of the specification, claims, and drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0022] FIG. 1 shows calcium spiking in rice in response to Myc-LCOs, Nod factors, and CO4. Representative calcium traces from rice atrichoblasts on lateral roots treated with 10 −8 M Myc-LCOs and LCO isolations from Rhizobium sp. NGR234 and R. tropici , as well as 10 −5 M and 10 −8 M treatments of CO4. The number of cells showing calcium spiking, relative to the total number of cells analyzed is indicated. [0023] FIG. 2 shows calcium spiking in rice in response to CO4 and CO8. Representative calcium traces from rice atrichoblasts on lateral roots treated with 10 −8 M and 10 −5 M CO4 and CO8. Plants appear to respond equally well to CO4 as to CO8. [0024] FIGS. 3A, 3B, and 3C show promotion of root system development in rice by NS-LCO, S-LCO, CO4, and CO8. The mean number of lateral roots ( FIG. 3A ), the length of the root system ( FIG. 3B ) and the number of crown roots ( FIG. 3C ) produced per rice plant is shown in response to treatments of 10 −8 M COs or LCOs. Plants were treated for 24 hours and then grown for two weeks before assessment. Results displayed are based on at least two replicated experiments (n≧28). The p-value was calculated using a t-test, assuming a normal distribution of the data, or a Wilcoxon signed-rank test when a normal distribution was not observed. Significance was determined within a 95% confidence interval. Error bars indicate standard error. [0025] FIGS. 4A, 4B, and 4C show that lateral root induction is dependent upon the symbiotic signalling pathway. The mean percentage of lateral roots ( FIG. 4A ), the length of the root system ( FIG. 4B ) and the number of crown roots ( FIG. 4C ) produced per rice plant is shown in response to treatments of 10 −8 M COs or LCOs in wild-type rice plants as well as Ospollux and Osdmi3 mutants. Plants were treated for 24 hours and then grown for two weeks before assessment. Results displayed are based on at least two replicated experiments and calculated as percentage over average of the control treatment (n≧28). The p-value was calculated using a t-test, assuming a normal distribution of the data, or a Wilcoxon signed-rank test when a normal distribution was not observed. Significance was determined within a 95% confidence interval. Error bars indicate standard error. [0026] FIG. 5 shows induction of calcium spiking in rice trichoblasts and atrichoblasts. The graph shows the percentage of calcium responsive cells among trichoblasts and atrichoblasts of rice. Treatments of 10 −5 M and 10 −8 M CO4 and the response of trichoblasts near R. irregularis hyphae were analyzed. [0027] FIG. 6 shows calcium responses to LCOs and COs in rice trichoblasts with representative calcium traces of root hair cells (trichoblasts) treated with mixes of 10 −8 M CO4, S-LCO, and NS-LCO. Note that mixes of Myc-LCOs with CO4 induced calcium oscillations, but the Myc-LCOs alone did not. The number of cells showing calcium responses, relative to the total number of cells analyzed is indicated. [0028] FIG. 7 shows promotion of lateral root emergence in M. truncatula by NS-LCO, but not by CO4. M. truncatula roots were treated with 10 −7 M CO4 or 10 −7 M NS-LCO and the effect on lateral root emergence was measured. The numbers in parentheses indicate the number of plants analyzed. The significance of the difference to the treated control plants, as measured using a t-test, is indicated. The treatments are measured as fold induction relative to the control. Error bars represent the standard error. [0029] FIG. 8 shows the in vitro effect of seed application on HRSW root system length. Compared with control treatment, CO4 treatment significantly promoted root growth. One star (*) indicates significant difference at the P<0.05 (n=15). [0030] FIG. 9 shows the “in pot” effect of seed application on HRSW seedling growth. Compared with control treatment, CO4 and CO8 treatment significantly promoted plant growth. One star (*) indicates significant difference at the P<0.05 (n=20). [0031] FIG. 10 shows the effect of seed application on rice shoot and root length. Rice seeds were treated with three different solutions of 0.5% ethanol (control), 10 −6 M CO4, or 10 −6 M CO8, and grown on modified Fahraeus medium for 33 days. The length of roots (left bar) and shoots (right bar) were measured. Compared with ethanol treatment, CO4 treatment significantly promoted shoot and root growth. One star (*) and two stars (**) indicate significant difference at the P<0.1, P<0.01 level each. (n=10). [0032] FIG. 11 shows the effect of seed application on corn lateral root development. Compared with control treatment, CO4 treatment significantly promoted lateral root production. One star (*) indicates significant difference at the p<0.1 (n=20). [0033] FIGS. 12 A and 12 B show the effect of foliar application on the shoot and root length. Three-weeks-old rice leaves were treated with three different solutions of 0.5% ethanol, 10 −6 M CO4, or 10 −6 M CO8 by painting brushes, and the length of shoots ( 12 A) and roots ( 12 B) were measured at treatment day ( 12 A left bar), 14 days after treatment ( 12 A center bar), and 18 days after treatment ( 12 A right bar and 12 B). Both shoot and root lengths of CO4 treated rice were significantly longer than ethanol treated ones at 14 days and 18 days. One star (*) and two stars (**) indicate significant difference at the P<0.1, P<0.01 level each (n=11). DETAILED DESCRIPTION A. In General [0034] This invention is not limited to the particular methodology, protocols, or reagents described, as these may vary. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention, which will be limited only by the appended claims. [0035] As used herein and in the appended claims, the singular forms “a”, “an” and “the” include plural reference, unless the context clearly dictates otherwise. As well, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. Also, the terms “comprising”, “including” and “having” can be used interchangeably. [0036] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, certain exemplary methods and materials are now described. B. The Invention [0037] The present invention provides methods and compositions for promoting plant growth and/or development in non-leguminous plants. [0038] The method includes the step of contacting a non-leguminous plant, a part thereof, or a seedling or seed thereof with a composition that includes a chitooligosaccharide (CO), as described above. [0039] The method used for contacting the composition with the plant, part thereof, or seedling or seed thereof (the “target”) can include any method known in the art, including, without limitation, spraying the target with the composition, dipping the target into the composition, soaking or submersing the target in the composition, coating the target with the composition, or adding the composition to the soil in proximity to the target, whereby the composition comes in contact with the composition. Optionally, to facilitate the contacting step, the composition is in the form of a liquid, such as an aqueous solution or an oil-based mixture. In such embodiments, the composition may further include a solubilizing agent that increases the solubility of the CO within the liquid composition, and/or a surfactant or wetting agent that facilitates maximum contact between the liquid composition and the plant or seed surface to which it is applied. [0040] The period for which the target is contacted with the composition can vary. In some embodiments, the composition is contacted with the plant, plant part, seedling or seed for about 5 minutes to about a week. Optionally, the contacting step occurs for a period that falls within a range having a lower value of about 10 minutes, about 20 minutes, about 30 minutes, about 40 minutes, about 50 minutes, about one hour, about two hours, about three hours, about four hours, about five hours, about six hours, about seven hours, about eight hours, about nine hours, about ten hours, about eleven hours, or about twelve hours. Optionally, the contacting step occurs for a period that falls within a range having an upper value of about 20 minutes, about 30 minutes, about 40 minutes, about 50 minutes, about one hour, about two hours, about three hours, about four hours, about five hours, about six hours, about seven hours, about eight hours, about nine hours, about ten hours, about eleven hours, about twelve hours, about one day, about two days, about three days, or about four days. [0041] The concentration of the CO in the composition can vary. Optionally, the concentration of the CO within the composition falls within a range having a lower value of about 10 −4 M, about 10 −5 M, about 10 −6 M, about 10 −7 M, about 10 −8 M, about 10 −9 M, about 10 −10 M, about 10 −11 M, or about 10 −12 M. Optionally, the concentration of the CO within the composition falls within a range having an upper value of about 10 −3 M, about 10 −4 M, about 10 −5 M, about 10 −6 M, about 10 −7 M, about 10 −8 M, about 10 −9 M, about 10 −10 M, about 10 −11 M, or about 10 −12 M. [0042] The compositions may include a single type of CO, but may also include mixtures of two or more distinctly different COs, as described above. C. Examples [0043] The following Examples are offered by way of illustration only, and not by way of limitation. Example 1 CO4 and CO8 Activate Symbiotic Signalling and Promote Root System Development in Rice [0044] Plants establish root symbioses with arbuscular mycorrhizal fungi to facilitate nutrient acquisition. Establishment of this interaction requires plant recognition of diffusible signals from the fungus, including lipochitooligosaccharides (LCDs) and chitooligosaccharides (COs). Nitrogen-fixing rhizobia bacteria that form symbioses with leguminous plants also signal to their hosts via LCOs (Nod factors). In legumes, it is thought that both the mycorrhizal and rhizobial symbioses use a common signaling pathway. [0045] In this example, we have assessed the induction of symbiotic signalling processes by the mycorrhizal (Myc)-produced LCOs and COs in rice, a model non-leguminous mycorrhizal plant. We show that the chitin oligomers CO4 and CO8, but not Myc-LCOs, activate symbiotic calcium oscillations in rice atrichoblasts, although CO4 and Myc-LCOs combined were required to induce calcium spiking in root hair cells. In contrast, lateral root emergence was promoted in rice by non-sulphated-LCO (NS-LC), sulphated-LCO (S-LCO), CO4 or CO8, in a DMI3 and POLLUX dependent manner. Our work demonstrates that COs such as CO4 and CO8 can be used to promote increased root system development in non-leguminous mycorrhizal plants, such as rice. [0046] Introduction [0047] To better understand the mechanisms by which AM fungi signal to non-leguminous host plants, we assessed the induction of symbiotic signalling in rice by the AM produced LCOs and COs. We show in this example that rice appears to respond primarily to COs for activation of calcium oscillations, rather than the LCOs that legumes respond to (although rice does respond to LCOs with the promotion of lateral root emergence). Furthermore, we show for the first time that COs, such as CO4 and CO8, can be used alone or in combination with LCOs to promote root system development in non-leguminous plant species, such as rice. We conclude that COs activate different symbiotic signalling processes in non-leguminous plant species, such as rice, from those activated in legumes. [0048] Materials and Methods [0049] Seed Preparation, Plant Growth Conditions, and Treatment with LCOs and COs. [0050] Oryza sativa cv Nipponbare wild-type and Tos17 insertion lines in POLLUX (line NC6453) and DMI3 (line 8513) were used for root architecture experiments (12, 13). Seeds were prepared by sterilizing with 2% bleach for 20 minutes, followed by 3, 5-minute rinses with sterile water. The sterile seeds were then imbibed overnight. Seeds were then plated on damp germination paper in Petri plates under sterile conditions and germinated in the dark at 25 degrees for 7 days. Germinated rice plants were then plated on Fahraeus medium on germination paper and grown at 22 degrees under constant light. After 5 days the plants were treated with 10 −8 M LCOs and COs for 24 hours by submersion and re-plated onto Fåhræus Medium 1.5% agar plates (0.132 g/L CaCl2, 0.12 g/L MgSO 4 .7H 2 O, 0.1 g/L KH 2 PO 4 , 0.075 g/L Na 2 HPO 4 .2H 2 O, 5 mg/L Fe-citrate, and 0.07 mg/L each of MnCl 2 .4H 2 O, CuSO 4 .5H 2 O, ZnCl 2 , H 3 BO 3 , and Na 2 MoO 4 .2H 2 O, adjusted to pH 6.5 before autoclaving). As all signals were suspended in 50% ethanol, the appropriate concentration of ethanol in sterile DI water served as a control. Root system architecture was assessed after 2 weeks. [0051] Calcium Imaging. [0052] Mycorrhizal induced calcium responses were measured as described previously (14). Transgenic Oryza sativa Nipponbare lines carrying Yellow Cameleon 3.6 (YC3.6) FRET-based calcium sensor was used to detect calcium spiking. YC3.6 was imaged on a Nikon Eclipse Ti inverted microscope (Nikon, Japan) equipped with an OptoLED Illuminator (model OptoLED, Cairn Research Ltd, UK). YC3.6 was excited at a wavelength of 455 nm using a royal blue LED and was captured with a charge-coupled device (CCD) camera (model RETIGA-SRV, Qimaging, Canada). Emitted fluorescence was separated by an image splitter with a dichroic mirror (model Optosplit II, Cairn Research Ltd, UK) and then passed through a fluorescence filter set. Images were collected every 5 seconds with 1-second exposure and analyzed using MetaFluor (Molecular Devices, Sunnyvale, Calif., USA). [0053] Mathematical Analysis of Calcium Oscillations. [0054] For Bayesian Spectrum Analysis we computed the most probable periods in the time series following published procedures (15). Ten traces per treatment were analyzed. The joint distributions over the period were used to characterize each group. The plots show binned data to summarize the key periods. These ten traces per treatment were also analyzed for interspike intervals. The point of maximum height for each spike was computed after detrending of the time series using a moving average algorithm. The distances between these maxima gave rise to an interspike distribution. We used the non-parametric Mann-Whitney U-test, also known as the Mann-Whitney-Wilcoxon test (16, 17) to test for significant differences between the distributions. [0055] Three traces per treatment, with approximately 80 spikes altogether, were analyzed for calcium spike characteristics. The time series had an interval of 5 seconds between data points. The traces were detrended using a moving average algorithm (18). We then characterized the spikes by the time required for each upward and downward phase. This was computed by the number of data points it took from the maximum spike height to the baseline fluctuation of the trace. The plots show the mean value of the upward and downward phases for each treatment, and the associated standard deviations are indicated by the error bars. [0056] Measurements of Root Architecture Modifications. [0057] Total lateral roots of rice were enumerated manually two weeks after application of 10 −8 M COs and LCOs. As COs and LCOs were suspended in 50% ethanol, the control is sterile deionized water containing the appropriate amount of ethanol. Lateral roots were defined as large and fine lateral roots emerging from crown roots, as well as fine lateral roots emerging from large lateral roots. Root system length was measured starting from the root-shoot junction to the tip of the longest root. The number of crown roots was assessed manually as those roots emerging from the root-shoot junction. Root type characterizations were based upon the descriptions in Gutjahr et al. (19). Data were assessed for normality using the Shapiro-Wilk test (α=0.01), and statistical significance was determined using a paired t-test assuming unequal variances, or a Mann-Whitney-Wilcoxon Test if normality was not observed (α=0.05). All statistical analysis was conducted using the R software package (20). [0058] Results [0059] Activation of Calcium Oscillations by Myc-LCOs and COs in Rice. [0060] Mycorrhizal fungi associate with a wide range of plant species, and at least in rice this association is dependent on the common symbiosis signalling pathway (12, 21-23). Hence, non-legumes should be able to recognize the mycorrhizal produced LCOs and/or COs. Two major species of LCOs have been characterized from exudates of R. irregularis : LCO-IV (C16:0, S or C18:1, S), which we will refer to as sulfated (S)-LCO and LCO-IV (C16:0 or C18:1), which we will refer to as non-sulfated (NS)-LCO (24). For this study, we used S-LCOs and NS-LCOs that were either purified from R. irregularis exudates or were synthesized in genetically-modified bacteria as previously described (24). To define the activation of the symbiosis signalling pathway by the AM-produced LCOs and COs, we assessed their ability to activate calcium oscillations, the pathway's earliest measurable event (3). [0061] Calcium responses were assessed using a stably transformed line of Oryza sativa cv Nipponbare carrying YC3.6. AM fungi have been shown to predominantly colonize the large lateral roots (19), and therefore, we focused on this root type. No calcium responses were observed following treatment with any of the LCOs assessed, but strong calcium oscillations were observed following treatment with 10 −5 M CO4 ( FIG. 1 ). To test an array of different LCO structures, we analyzed calcium spiking in response to Nod factor isolations from the broad host range rhizobial species, Rhizobium sp. NGR234, as well as Rhizobium tropici , in addition to the Myc-LCOs. Considering that these LCO treatments were performed with 10 −5 M, we are confident that rice does not respond to the Nod factors or Myc factors tested. Treatments with 10 −8 M CO4 still showed calcium oscillations in rice epidermal cells, but the robustness of the response was reduced and the number of responsive cells was also reduced ( FIG. 1 ). Unlike results reported in M. truncatula , rice appears to respond equally well to both CO4 and CO8 with calcium oscillations ( FIG. 2 ). [0062] Mycorrhizal LCOs and COs Induce Rice Root Architecture Modification. [0063] Rice has been shown to respond to AM fungi and exudates from the spores of AM fungi, with changes to root structure, in particular, the promotion of lateral root outgrowth (19, 25). These responses were independent of the common symbiosis signalling pathway. In contrast, we have observed CO4 and CO8 induction of the common symbiosis signalling pathway in rice as measured by the activation of calcium oscillations. In an attempt to understand these seemingly contradictory results, we tested the promotion of lateral root outgrowth in rice by S-LCO, NS-LCO, CO4 and CO8. This study showed that NS-LCO, S-LCO, CO4 and CO8 all promoted lateral root and crown root growth in rice ( FIG. 3 ). Interestingly, root system length was only enhanced upon application of NS-LCOs ( FIG. 3 ). These results imply that COs and LCOs activate two modalities of signalling in rice: calcium oscillations that are activated by COs and a separate signalling pathway activated by both LCOs and COs that is associated with changes to root architecture. [0064] Root Architecture Modification by COs and LCOs are DMI3 and POLLUX Dependent. [0065] To assess the role of the common symbiotic pathway in regulating root architecture modifications in response to purified LCOs and COs, we quantified root responses to mycorrhizal signals in rice knock-out mutants of pollux (upstream of calcium spiking) and dmi3 (downstream of calcium spiking). We found that lateral root growth promotion by LCOs and CO4 was dependent on both POLLUX and DMI3, while the response to CO8 was dependent on POLLUX ( FIG. 4 ). The increase in crown root growth by both LCOs and COs was dependent upon DMI3 and POLLUX, and there were significantly fewer crown roots in response to all treatments in the pollux mutant ( FIG. 4 ). Finally, the overall root length increase observed in response to NS-LCO was dependent upon both POLLUX and DMI3 ( FIG. 4 ). These results demonstrate that root architecture changes in response to purified mycorrhizal signals require proteins of the common symbiotic pathway. [0066] Both LCOs and COs are Required to Induce Calcium Spiking in Trichoblasts. [0067] Rhizobia colonize legumes by root hair cells (trichoblasts), whereas AM fungi colonize roots via non-root hair epidermal cells (atrichoblasts). Thus, these different root epidermal cell types may respond differently to COs and LCOs. To test this, we directly compared trichoblast and atrichoblast responses using high concentrations of CO4 in rice. Calcium oscillations observed in rice following treatments of CO4 were restricted to atrichoblasts, with no responses in trichoblasts even with CO4 treatments of 10 −5 M ( FIG. 5 ). This preferential nature of rice atrichoblasts to respond to the AM signals is consistent with a preference for AM fungi to colonize the root via atrichoblasts (26). It is possible that either AM fungi produce signalling molecules other than S-LCO, NS-LCO and CO4 that induce calcium oscillations in rice trichoblasts, or that the mix of signalling molecules is important. To test this, we assessed induction of calcium oscillations by an equimolar mix of 10 −5 M S-LCO, NS-LCO, and CO4. Strikingly, we observed calcium spiking in rice root hair cells when treated with this mix of signal molecules, yet these signal molecules, when applied individually at 10-5 M, did not induce calcium spiking ( FIG. 6 ). [0068] Discussion [0069] COs and LCOs Act Synergistically as Symbiotic Signals in Rice. [0070] AM fungi signal to the host plant via diffusible signals (14, 25-27), and at least some of these signals are LCOs (24) and COs (9). In this example, we show that the AM-produced COs can activate calcium oscillations in rice. S-LCO and NS-LCO were purified from exudates of AM fungi based on their capability to activate symbiotic responses in M. truncatula that were dependent on the common symbiosis signalling pathway (24). The fact that these LCOs do not trigger calcium spiking in rice may reflect this selectivity in their initial identification. However, rice can sense LCOs since the mix of Myc-LCOs and CO4 activated calcium oscillations in rice root hair cells and LCOs can also promote lateral and crown root growth. Therefore, the absence of calcium responses in rice to the LCO treatments alone does not indicate a lack of response of LCOs by rice. [0071] Our work has revealed a close correlation between the cell-type and its responsiveness to LCOs and CO4. We observed that calcium responses to COs were restricted to atrichoblasts in rice. This preferential response in atrichoblasts correlates well with a preferential colonization of atrichoblasts by AM fungi (26). However, we observed calcium oscillations in rice trichoblasts in treatments where LCOs and CO4 were combined. It would appear that responses in rice trichoblasts are at least partially explained by the mix of LCOs and CO4 produced by the AM fungus. Interestingly, it was shown some years ago that a mix of Nod factors and COs was better at inducing nodulation associated gene expression in soybean than Nod factor treatments alone (28). Perhaps these earlier observations reflect responses to AM fungi, rather than what was previously thought to be a rhizobial response. Alternatively, a mix of LCOs and COs may be relevant in rhizobial interactions as well as AM associations. [0072] Multiple Pathways Mediate LCO and CO Responses in Rice. [0073] We established that rice can distinguish between LCOs, CO4, and CO8, and responds accordingly with either calcium oscillations and/or root architecture modifications. The fact that rice responds to AM fungi with at least two separate signalling pathways has already been shown (23), and the promotion of lateral roots by AM fungi in a manner independent of the common symbiosis signalling pathway was also already shown (25). Thus, there is ample evidence in rice for two pathways of symbiosis signalling. Our work shows that root architecture modification in response to LCOs and CO4 requires the common symbiotic pathway; however, CO8 does not require DMI3. The ability of AM fungi to stimulate lateral root emergence independent of the symbiotic pathway may indicate that the plant responds differently to a mixture of signals and stimuli than it does to purified signals and that during symbiosis the pathway governing root architecture modification does not require calcium spiking to be initiated. [0074] In Arabidopsis , lateral root development is under the control of auxin signalling modules. Under high auxin conditions, lateral root founder cells polarize and divide (29). Further rounds of cell division result in lateral root emergence at specific sites in the root. The process leading to lateral root emergence is similar in rice and using the DR5:GUS auxin reporter system, auxin was shown to accumulate in emerging lateral roots (30). Under high auxin concentrations, AUX/IAA proteins are degraded. AUX/IAA proteins repress ARF transcriptional activators, and thus their degradation leads to the transcription of auxin-responsive genes (29). Auxin positively regulates lateral root formation, as a rice plant containing a constitutively active version of IAA13 has fewer lateral roots than wild type (31). Interestingly, auxin signalling is also implicated in the production of crown roots in rice (32, 33). It seems likely, therefore, that the application of LCOs and COs activates the auxin-dependent lateral root and crown root emergence programs. Given that this phenotype was dependent on DMI3 and POLLUX in the case of Myc-LCOs and CO4, it may be that there is cross talk between the common symbiosis pathway and auxin signaling, which results in increased lateral root emergence and crown root growth. Assessing expression of auxin-responsive genes in Ospollux and Osdmi3 mutants in response to COs and LCOs may reveal the mechanisms of this signalling pathway. CONCLUSION [0075] AM fungi have the distinctive capability of colonizing a broad group of plants. In this example, we demonstrate that CO4 and CO8 form at least part of the spectrum of AM symbiotic signals that can be recognized by a variety of plant species to activate a range of symbiotic signalling processes. More specifically, both CO4 and CO8 can be used to promote increased root system development in non-leguminous plants, such as rice. REFERENCES CITED [0000] 1. Harrison M J (2005) Signaling in the arbuscular mycorrhizal symbiosis. Annu Rev Microbiol 59:19-42. 2. 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Example 2 CO4 does not Promote Root System Development in Legumes [0109] This example shows that the results obtained in Example 1 using rice, a non-leguminous mycorrhizal plant model, cannot be replicated in legumes. Specifically, we demonstrate that in M. truncatula , stimulation of lateral root emergence occurred following treatment with Myc-LCOs, but not following treatment with CO4. In contrast, Example 1 showed that both Myc-LCOs and CO4 (along with CO8) promoted increased root system development in rice. This work indicates that legumes and non-legumes differ in their perception of Myc-LCO and CO signals, suggesting that legume and non-legume species respond to different components in the mix of signals produced by arbuscular mycorrhizal fungi. [0110] Results [0111] LCOs, CO4, and CO8 Promote Root Development in Rice, while LCOs, but not COs, Promote Root Development in the Legume M. truncatula. [0112] We tested the promotion of lateral root outgrowth in rice by S-LCO, NS-LCO, CO4, and CO8, and found that all four molecules could promote lateral root outgrowth and enhance overall root system growth (see Example 1). In contrast to what we observed in rice, using the protocol of Example 1, CO4 could not induce lateral root emergence in M. truncatula ( FIG. 7 ), but the Myc-LCOs can activate this response (Maillet, F., et al. (2011), Nature 469: 58-63). This demonstrates that legumes and non-legumes differ fundamentally in their response to the spectrum of Myc-LCOs and COs for modifications to root architecture. Accordingly, the disclosed method is limited in scope to treating non-leguminous plants, or seeds, seedlings or plant parts thereof. Example 3 The Effect of CO4 and CO8 Seed Treatment on Growth and Development of Hard Red Spring Wheat, Rice and Corn [0113] This example demonstrates that CO4 and/or CO8 when applied to the seeds of three different grain crop plants, promotes the growth of the plants, as measured by one or more parameters of plant growth or development. Experiment 1 Effects of CO4 and CO8 Treatment on Hard Red Spring Wheat (HRSW) In Vitro [0114] Methods [0115] Hard red spring wheat seeds were surface sterilized using ethanol and bleach. The sterilized seeds were then divided among 4 treatment groups of 5 grams each into 50 ml falcon tubes. To the control tube, 0.5% ethanol in water was added. To the CO4 tube, 125 μl of 10 −6 M CO4 solution was added. To the CO8 tube, 125 μl of 10 −6 M CO8 solution was added. To the “Consensus” tube, 125 μl of 10 −6 M solution of chitosan (CONSENSUS® chitosan; Loveland Products, Inc., Loveland, Colo.) was added. Each tube was then shaken to coat the seeds. The coated seeds were then placed on sterile Petri dishes in a hood and were left to dry overnight in the hood. [0116] The seeds were then germinated on damp germination paper in sterile Petri dishes for 4 days. The resulting seedlings were transferred to Fahräeus medium plates containing damp germination paper, and the plates were wrapped in Parafilm®. Fahräeus medium contains 0.5 m M MgSO 4 , 0.7 mM KH 2 PO 4 , 0.4 mM Na 2 HPO 4 , 0.02 mM Fe-EDTA, 0.01 mM MnSO 4 , 0.007 mM CuSO 4 , 0.006 mM ZnSO 4 , 0.016 mM H 3 BO 3 , 0.001 mM Na 2 MoO 4 , and 15 g/L Agar for plant tissue, adjusted to pH 6.5 before autoclaving. The plants were grown at room temperature under continuous light for 4-5 days. The number of primary roots (PR), lateral roots (LR), root system length (RSL) and dry weight (DW) was then measured for all plants. [0117] Results [0118] The results are tabulated in Table 1 below: [0000] TABLE 1 Measured Parameters for Control, CO8, CO4 and Consensus Treatment Groups (Wheat) Number of Number of Primary Lateral Root System Dry Weight Treatment Roots Roots Length (cm) (g) Control 5.64 3.21 11.82 0.0194 CO8 5.20 3.00 11.51 0.0191 CO4 5.20 3.73 13.21* 0.0206 Consensus 5.27 3.53 11.52 0.0213 *Significant difference at P < 0.05 [0119] CO4 treatment significantly increased root system length over the control (see also FIG. 8 ), indicating that the treatment facilitates at least one growth parameter in wheat. Experiment 2 Effects of CO4 and CO8 Treatment on Hard Red Spring Wheat in Pots [0120] Methods [0121] Five grams of hard red spring wheat seeds were added to three separate 50 ml tubes. A water solution containing 0.5% ethanol was added to the control tube, 125 μl of 10 −6 M CO4 solution was added to the CO4 tube, and 125 μl of 10 −6 M CO8 solution was added to the CO8 tube. Each tube was then shaken to coat the seeds. Seeds were potted immediately following treatment into moistened SUNGRO® potting mix in 4×6×6 cm pots. Plants were watered by pouring water into the tray containing the pots up to about ¾ inch high. [0122] After sowing the seeds, the pots were randomly distributed (16 pots per treatment) throughout the tray and placed underneath continuous light at room temperature for 1 week. Liquid Fahräeus medium (plant fertilizer solution; see above) was applied every 2 days or when necessary. After a week, the pots were placed underneath 10 h light and 14 h dark cycle at room temperature for 1 week. After 1 week underneath 10 h light and 14 h dark cycle (2 weeks after planting), the plants were carefully removed from the pots, and as much soil as possible was shaken off. The remaining soil was removed by submerging the root system into a beaker of water. [0123] The number of primary roots (PR), lateral roots (LR), root system length (RSL) and dry weight (DW) was then measured for all plants. [0124] Results [0125] The results are tabulated in Table 2 below: [0000] TABLE 2 Measured Parameters for Control, CO8 and CO4 Treatment Groups (Wheat) Number of Number of Primary Lateral Root System Dry Weight Treatment Roots Roots Length (cm) (mg) Control 3.30 14.45 10.70 24.03 CO8 3.35 14.30 12.22 32.38* CO4 3.15 16.25 11.75 30.20* *Significant difference at P < 0.05 [0126] Both CO4 and CO8 seed treatments significantly increased dry weight (a measurement of total plant growth) in the wheat plants (see also FIG. 9 ), confirming that such treatments facilitate plant growth in wheat. A similar dry weight increase was not shown with plants grown in plates in Experiment 1 above, likely because of the limitations on growth that plates impose. Average root system length was also higher for both CO4 and CO8 treatments, although the increased length was not great enough to be significant at P<0.05. [0127] Together, the results of Experiment 1 and 2 demonstrate that CO4 and/or CO8 treatment of wheat seeds facilitates growth and development of the wheat plants that germinate from the treated seeds. Experiment 3 Effects of CO4 and CO8 Treatment on Rice In Vitro [0128] Methods [0129] Rice seeds were sterilized using 2% bleach. The sterilized seeds were then divided among 3 treatment groups of 10 seeds each into 15 ml falcon tubes. To the control tube, 0.5% ethanol in water was added. To the CO4 tube, 100 μl of 10 −6 M CO4 solution was added. To the CO8 tube, 100 μl of 10 −6 M CO8 solution was added. Each tube was then shaken to coat the seeds. The coated seeds were then placed on sterile Petri dishes in a hood and were left to dry overnight in the hood. [0130] The seeds were then germinated on damp germination paper in sterile Petri dishes for 5 days. The resulting seedlings were transferred to Fahräeus medium plates containing damp germination paper, and the plates were wrapped in Parafilm®. The roots part of the plate was covered with aluminum foil. The plants were grown at room temperature under continuous light for 33 days. The length of the shoot and root systems was measured for all plants. [0131] Results [0132] CO4 treatment significantly increased both shoot and root system length compared with the ethanol control (see FIG. 10 ). This data supplements the data disclosed in Example 1 above indicating that both CO4 and CO8 treatment can be used to facilitate growth and development in rice. Experiment 4 Effects of CO4 and CO8 Treatment on Corn in Pots [0133] Methods [0134] Five grams of corn (maize) seeds were added to three separate 50 ml tubes. A water solution containing 0.5% ethanol was added to the control tube, 125 μl of 10 −6 M CO4 solution was added to the CO4 tube, and 125 μl of 10 −6 M CO8 solution was added to the CO8 tube. Each tube was then shaken to coat the seeds. Seeds were potted immediately following treatment into moistened SUNGRO® potting mix in 4×6×6 cm pots. Plants were watered by pouring water into the tray containing the pots up to about ¾ inch high. [0135] After sowing the seeds, the pots were randomly distributed (16 pots per treatment) throughout the tray and placed underneath continuous light at room temperature for 1 week. Liquid Fahräeus medium (plant fertilizer solution; see above) was applied every 2 days or when necessary. After a week, the pots were placed underneath 10 h light and 14 h dark cycle at room temperature for 1 week. After 1 week underneath 10 h light and 14 h dark cycle (2 weeks after planting), the plants were carefully removed from the pots, and as much soil as possible was shaken off. The remaining soil was removed by submerging the root system into a beaker of water. [0136] The number of primary roots (PR), lateral roots (LR), root system length (RSL) and dry weight (DW) was then measured for all plants. [0137] Results [0138] The results are tabulated in Table 3 below. As shown in Table 3 and FIG. 11 , corn plants resulting from seeds receiving both CO4 and CO8 treatments exhibited increased number of lateral roots, as compared to corn plants resulting from seeds receiving the control treatment. However, the increased lateral root development with CO8 treatment was not great enough to be significant at P<0.1, likely due to high variability. CO4 did significantly increase lateral root growth at P<0.1. This experiment demonstrates that the disclosed seed treatment method can be used to facilitate growth in corn. [0000] TABLE 3 Measured Parameters for Control, CO8 and CO4 and Treatment Groups (Corn) Average Root Dry Treatment Seminal Roots Lateral Roots System Length Weight Control 4.40 38.95 21.53 0.1176 CO4 4.45 45.00* 23.76 0.1225 CO8 4.75 44.95 21.42 0.1229 *Significant difference at P < 0.1 Example 4 The Effect of CO4 and CO8 Foliar Treatment on Root/Shoot Growth of Rice [0139] This example extends the results of the previous examples to foliar treatment in rice. Specifically, foliar treatment with CO4 in rice is shown to facilitate both shoot growth and root growth. [0140] Methods [0141] Rice seeds were surface sterilized using 2% bleach. Seeds were then germinated on damp germination paper in sterile Petri dishes for 5 days. The seedlings were then transferred to Fahraeus medium plates containing damp germination paper. The plates were wrapped in Parafilm®, and the roots part of the plate covered with aluminum foil. [0142] The plants were grown at room temperature under continuous light for 21 days. The plants were then transferred to moistened SUNGRO® soil pots (8×8×10 cm) and grown for 3 days under greenhouse condition. The plants were hydrated by pouring water into the tray underneath the pots. [0143] The soil surface was then covered with plastic wrap to prevent any liquid droplets from contacting the soil. Using painting brushes, the front, and back of the plant leaves were treated with 3 ml of chitin derived compounds (CO4 and CO8) at 10 −6 M or a control (0.5% ethanol), each including 0.05% of Silwet L-77 (surfactant). Eleven plants were treated with each solution. The plants were subsequently grown for 14 days, and the shoot length was measured. Once a week, half-strength Hoagland solution was added into the trays underneath the pots. The plants were grown for another 4 days, and the lengths of the shoot and root systems were measured. [0144] Results [0145] CO4 foliar treatment on rice significantly increased shoot length at day 14 after treatment, and the significance was even higher at day 18 ( FIG. 12A ). CO4 treatment also significantly promoted root system length at day 18 ( FIG. 12B ). In sum, this example shows that foliar application of CO4 in rice promotes plant growth in the rice. Example 5 CO4 and CO8 Seed Treatment Reduce Root Growth in an Exemplary Legume [0146] Consistent with the results reported in Example 2, this example confirms that the results reported in various non-leguminous plants (see Examples 1, 3 and 4) cannot be replicated in legumes. Thus, the disclosed method is limited to non-leguminous plants. [0147] Methods [0148] Five grams of pea seeds (the legume Pisum sativum ) were added to three separate 50 ml tubes. A water solution containing 0.5% ethanol was added to the control tube, 125 μl of 10 −6 M CO4 solution was added to the CO4 tube, and 125 μl of 10 −6 M CO8 solution was added to the CO8 tube. Each tube was then shaken to coat the seeds. Seeds were potted immediately following treatment into moistened SUNGRO® potting mix in 4×6×6 cm pots. Plants were watered by pouring water into the tray containing the pots up to about ¾ inch high. [0149] After sowing the seeds, the pots were randomly distributed (16 pots per treatment) throughout the tray and placed underneath continuous light at room temperature for 1 week. Liquid Fahräeus medium (plant fertilizer solution; see above) was applied every 2 days or when necessary. After a week, the pots were placed underneath 10 h light and 14 h dark cycle at room temperature for 1 week. After 1 week underneath 10 h light and 14 h dark cycle (2 weeks after planting), the plants were carefully removed from the pots, and as much soil as possible was shaken off. The remaining soil was removed by submerging the root system into a beaker of water. [0150] The number of primary roots (PR), lateral roots (LR), root system length (RSL) and dry weight (DW) were then measured for all plants. [0151] Results [0152] The results are tabulated in Table 4 below: [0000] TABLE 4 Measured Parameters for Control, CO8 and CO4 Treatment Groups (Peas) Average Lateral Tap Root Treatment Primary Roots Roots Length Dry Weight Control 18.45 22.45 10.31 .15 CO4 14.20* 13.35* 10.25 .13 CO4 15.50* 15.00* 10.28 .14 *Significant difference at P < 0.05 [0153] In contrast to the results demonstrated with non-leguminous plants, CO4, and CO8 seed treatments significantly decreased the number of primary and lateral roots of pea seedlings compared to the control. None of the other variables were affected by the CO treatment. [0154] Together, the results of Example 2 and this example demonstrate that the disclosed chitin oligomers cannot be used to promote the growth and/or development of leguminous plants. Accordingly, the disclosed method is limited to promoting the growth and/or development of non-leguminous plants. [0155] The examples and embodiments described herein are for illustrative purposes only. Various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and scope of the appended claims. All publications, patents, and patent applications cited herein are hereby incorporated by reference in their entirety for all purposes.

Methods for stimulating the growth of non-leguminous plants are disclosed. In the methods, a non-leguminous plant, a part thereof, or a seedling or seed thereof is contacted with a composition comprising a chitooligosaccharide (CO) having the formula: R1 is —H, —CH 3 , —COCH 3 , —SO 3 H, —SO 3 Na, arabinose, methylated arabinose, fucose, or methylated fucose; R2 is —H, —CH 3 , —COCH 3 , —SO 3 H, —SO 3 Na, arabinose, methylated arabinose, fucose, or methylated fucose; each R3 is independently —H or —COCH 3 ; and n is 0, 1, 2, 3, 4, 5 or 6. As non-limiting examples, the method can be used to stimulate production and yield in a cereal grain crop plant, such as rice, wheat or corn (maize).

This application claims benefit of provisional application No. 60/072,296, filed Jan. 23, 1998. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to impact resistant cushions adapted for use in carrying cases and to carrying cases for securely transporting delicate instruments such as portable computers. 2. Discussion of the Prior Art "Laptop" and "Notebook" portable personal computers have reduced size and weight and are conveniently carried and used while traveling. Manufacturers of portable personal computers strive to provide the smallest, lightest computer possible. Unfortunately, it is difficult to manufacture a small, light, portable computer rugged enough to withstand being dropped or otherwise subjected to shock loading. The small size of today's portable computers leaves little or no internal room for shock absorbing materials to protect the vulnerable operating parts of the computer such as the LCD screen, the hard drive, the mother board, the various electrical connectors or the plastic outer case. The effect of being dropped or hit is measured in terms of acceleration as compared to the earth's gravitational pull; one "G" represents an acceleration (or deceleration) of thirty two feet/sec 2 . Each computer manufacturer's design is different, and so there is no universally safe level of shock for portable computers. Manufacturers of hard drives typically specify that drives can withstand shocks in the range of seventy five to two hundred Gs. Manufacturers of LCD screens, on the other hand, guarantee their screens to withstand shocks of only as much as fifty Gs, a level reached by dropping a portable computer from a height of only six to seven inches. Since carrying cases for portable computers are usually hand held or hung from shoulder straps more than six inches from the ground, it is important that the cases provide adequate protection from the falls and bumps typically encountered in every day travel and use. Many manufacturers of carrying cases for portable computers incorporate foam padding into their cases, the padding typically ranges in thickness from one half to by about three inches. Foam padding will protect a computer, unless the padding is compressed completely (i.e., compressed to half the thickness of the foam pad). Thus, three inches of padding will protect the computer through a deceleration distance of one and one half inches. Tests have shown that in carrying cases provided with two inches of foam padding, the fifty G threshold (for LCD screens) is exceeded in drops from as little as eight inches in height. A carrying case offering superior protection against shocks is disclosed in U.S. Pat. No. 5,217,119 and is marketed by PORT Computer Cases of South Norwalk, Conn. The case disclosed in U.S. Pat. No. 5,217,119 includes a suspension system using an elastic sling. The computer is protected within the sling through the full distance of the decelerating fall, without resting on a foam barrier. The empty space below the sling, to the bottom of the case, provides twice as much protection as an equivalent amount of foam rubber padding. U.S. Pat. 5,524,754, assigned to PORT, Inc., discloses a carrying case for a notebook computer having a suspension system elastically supporting and protecting the computer during transport and allowing the computer to be used without removal from the case. The disclosures of U.S. Pat. Nos. 5,217,119 and 5,524,754 are incorporated herein by reference, in their entireties. While the carrying case structures of the '119 and '754 patents provide a high level of protection against shocks, it is desired to produce a computer carrying case exhibiting the same high level of protection from shocks while also allowing the user to adapt the computer support structure to accommodate a portable computer or other instruments of varying sizes, and allowing more economical manufacture. OBJECTS AND SUMMARY OF THE INVENTION Accordingly, it is a primary object of the present invention to support a portable computer (or other delicate instrument) of virtually any size or shape in a carrying case having a system of adjustable impact resistant cushions. It is another object of the present invention to provide a luggage insert including a system of adjustable cushions specially adapted to conform to the shape of a portable computer. It is yet another object of the present invention to provide a carrying case having an adjustable cushion system releasably fastened into the carrying case interior and positionable by the user, to accommodate computers having irregular sizes or shapes. Yet another object of the present invention is to provide adjustable, impact resistant cushions using a reduced quantity of cushion material and permitting relatively easy and economical manufacture. Another object of the present invention is to protect delicate instruments with one or more adjustable, impact resistant cushions having improved dynamic resistance to shock loading. The aforesaid objects are achieved individually and in combination, and it is not intended that the present invention be construed as requiring two or more of the objects to be combined unless expressly required by the claims attached hereto. In accordance with the present invention, an adjustable, impact resistant cushion for use in a carrying case or the like has a first pad including a compressible, substantially rectangular foam piece, formed of one or more foam blocks, covered with a pliable non-porous cover. The cover contiguously envelops the foam piece and includes an air flow controlling vent. Air escapes from the enveloped foam piece at a controlled rate through the vent when the foam material is compressed, and so the pad absorbs shock by providing velocity-dependent resistance to compression, wherein compression resistance force increases with increasing compression velocity, in the same manner as a shock absorber or dashpot. Preferably, the compressible foam piece is open cell urethane foam. The adjustable impact resistant cushion also includes a second pad having a substantially rectangular compressible foam piece, preferably of a greater thickness than the first pad foam piece, and a pliable non-porous cover contiguously enveloping the foam piece. The second pad also includes an air flow controlling vent for controlling the escape of air to absorb shock and provide velocity-dependant resistance to compression. The first and second pads of the adjustable cushion are hingedly connected to one another by a flexible hinge segment of webbing or plastic, and the adjustable cushion includes, on a back surface, one or more releasable hook and loop type fastener elements. In another embodiment of the adjustable impact resistant cushion of the present invention, the cushion has a substantially planar backing having a first elongate leg or resilient support member hingedly connected to a second elongate leg or support member. The first leg is connected at a distal end to the end of the first pad and hingedly connected at a second end opposing the distal end to the second leg connected at a distal end to the opposite end of the second pad, thereby forming a folded parallelogram of cooperatively hinged elongate pads and hinged elongate support members attached only at the distal ends. In the second embodiment of the cushion of the present invention, releasable hook and loop fastener elements are carried by the first and second legs of the planar backing. Preferably, two adjustable, impact resistant cushions are used in a luggage insert (for insertion into a carrying case or other luggage) or are incorporated directly into the interior portion of a carrying case having a compartment with an interior surface covered with felt or loop material for attachment using complementary hook fastener arrays carried by the adjustable cushions are vice versa. An adjustable cushion may also carry one or more flexible tabs bearing hook fastener arrays and extending perpendicularly or outwardly from the cushion pad major axis. The cushions are readily positioned in cushion pairs at selected separations and angular orientations, thereby accommodating portable computers having different widths and shapes. A luggage insert in accordance with the present invention provides impact resistant support for a portable computer or other delicate instrument and includes a container or receptacle portion having a compartment interior surface with loop fastener elements, felt, or another surface adapted to receive and hold the cushion hook fastener elements. Preferably, the insert is shaped substantially as a six-sided box having a front wall opposing a back wall and adjacent a top wall opposing a bottom wall which is also adjacent a left side wall opposing a right side wall. In the simplest embodiment, one pair of opposing walls (on the container interior or compartment) carry fastener elements (e.g., loops) for receiving complementary fastener elements (e.g., hooks) on the adjustable impact resistant cushions. Each impact resistant cushion preferably includes a hinge segment and is placed with a first pad on a compartment side wall, for example, and a second pad on the bottom wall of the compartment and positioned substantially at a right angle to the first pad. The second impact resistant cushion is placed with a first pad on the compartment side wall opposing the side wall having the first impact resistant cushion first pad and has the second pad positioned substantially at a right angle thereto, on the bottom wall, substantially in line with the second pad of the first impact resistant cushion. The compartment has a lineal dimension (e.g., along the bottom wall) greater than the combined dimensions of the second pads of the first and second cushions. Using the fasteners on the flexible tabs carried by, preferably, at least one of the adjustable impact resistant cushions, it is possible to adjustably position the cushion with a first pad spaced apart from the side wall of the compartment while the second pad rests on the bottom wall, thereby accommodating a portable computer having a narrower outer case or housing. The carrying case receives and supports the user-adjustable cushions in a plurality of positions or angular orientations, thereby accommodating irregularly shaped delicate instruments or computers. The above and still further objects, features and advantages of the present invention will become apparent upon consideration of the following detailed description of a specific embodiment thereof, particularly when taken in conjunction with the accompanying drawings wherein like reference numerals in the various figures are utilized to designate like components. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1. is a cut-away view, in perspective, of a carrying case in accordance with the present invention illustrating the user-positionable, impact resistant, adjustable cushions supporting a portable computer. FIG. 2 is a cut-away view, in perspective, of a carrying case in accordance with the present invention showing the adjustable cushions positioned against the carrying case sidewalls at the maximum separation. FIG. 3 is a cut-away view, in perspective, of the carrying case of FIG. 2, showing the adjustable cushions of the present invention positioned closer to one another. FIG. 4 is a side view of the impact resistant adjustable cushion of the present invention including three pad segments, oriented in a "C" shape. FIG. 5 is a side view of the cushion of FIG. 4 positioned in the linear orientation. FIG. 6 is a top view of the cushion of FIG. 5. FIG. 7 is a cut-away view, in perspective, of a luggage insert or receptacle illustrating a pair of adjustable cushions of FIG. 4, in a spaced apart orientation. FIG. 8 is a cut-away view, in perspective, of the adjustable cushions of FIG. 4 in a luggage insert receptacle, showing the cushions spaced more closely together. FIG. 9 is a cut-away view, in perspective, of a second embodiment of the carrying case of the present invention, showing spaced apart positioning of the adjustable cushions. FIG. 10 is a cut-away view, in perspective, of the carrying case of FIG. 9 showing the cushions positioned more closely together. FIG. 11 is a top view of an adjustable cushion with outwardly extended fastener tabs. FIG. 12 is a side view of the adjustable cushion of FIG. 11. FIG. 13 is a side view of the adjustable cushion of FIG. 12 arranged in an L-shape. FIG. 14 is a side view of the adjustable cushion of FIG. 12, with the backing member spaced apart from the first and second pads. FIG. 15 is a top view of an adjustable cushion for use in conjunction with the adjustable cushion of FIG. 11. FIG. 16 is a side view of the adjustable cushion of FIG. 15. FIG. 17 is a side view of the adjustable cushion of FIG. 16 arranged in an L-shape. FIG. 18 is a side view of the adjustable cushion of FIG. 16, with the backing member spaced apart from the first and second pads. FIG. 19 is a cut-away perspective view of a luggage insert or receptacle in which are disposed first and second adjustable impact absorbing cushions in a spaced apart orientation. FIG. 20 is a cut-away perspective illustration of the luggage insert of FIG. 19 with the adjustable cushions positioned closer together. FIG. 21 is a side view of the compartment within the luggage insert of FIG. 19, showing a spaced apart and vertical orientation of the adjustable cushions. FIG. 22 is a side view of the luggage insert of FIG. 21 showing an angled orientation for the adjustable cushions of the present invention. FIG. 23 is another side view of the luggage insert of FIG. 21 showing another angled orientation of the adjustable cushions of the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring specifically to FIGS. 1, 2 and 3, a carrying case 10 enclosing an inner compartment 11 is adapted to support a portable computer 12 or other delicate instrument within first adjustably positionable impact resistant cushion 14 and second adjustably positionable impact resistant cushion 16. Carrying case 10, according to the present invention, includes a box shaped exterior with a front wall 18 opposing a back wall 20 and adjacent left and right opposing side walls 22 and 24, and top and bottom side walls 26 and 28. Top, bottom, left and right side walls 22, 24, 26 and 28 extend between front wall 18 and back wall 20 to form a generally rectangular, enclosed box-like frame with a zippered opening 30 substantially intermediate front and back edges of the left wall 22, right wall 24 and top wall 26 to selectively close or open case 10 and allow access to interior compartment 11. In the closed condition shown in FIG. 1, front wall 18, back wall 20, left and right side walls 22, 24, and top and bottom side walls 26, 28 cooperate to define the boundaries of an enclosed compartment 11 which is adapted for receiving a laptop, notebook or sub-notebook sized portable computer 12 or other delicate instrument or object for transportation or storage. Preferably, at least one handle 32 is attached to front wall 18, back wall 20 and/or top wall 26 forming an elevated loop for grasping with one hand to transport or maneuver case 10. Optionally, a shoulder strap 33 can be detachably attached, preferably on rings affixed to the side walls, 22, 24, forming a second larger elevated loop for transporting case 10. Bottom side wall 28 includes a flexible region or hinge 34 to allow pivoting of front wall 18 away from back wall 20 when zippered opening 30 is divided and case 10 is spread in an opened condition, thereby allowing access to compartment 11. An elongate substantially planar partition 36 (shown in hidden lines) within compartment 11 provides a stabilizing lateral support or boundary and extends from left side wall 22 to right side wall 24; partition 36 preferably is detachably fastenable to the side and bottom walls with flexible tabs bearing hook fasteners or the like (not shown). Front and back walls 18, 20, left and right side walls 22, 24 and top and bottom side walls 26, 28 can have any desired configuration for defining boundaries of compartment 11 in a suitable size for holding portable computer 12 or the like and form a carrying case of the type commonly referred to as an attache or portfolio. Carrying case 10 is preferably fabricated of leather, fabric or a synthetic fabric such as ballistic nylon and may include padded stiffening panels encased by the fabric material forming the outer covering. In the carrying case shown in FIGS. 1-3, hinge 34 is also integrally formed of the covering material. In accordance with the present invention, an adjustable support system comprises first user positionable, adjustable, impact resistant cushion 14 and second user positionable, adjustable, impact resistant cushion 16. First cushion 14 and second cushion 16 are releasably fastened to an interior surface of compartment 11 to Add define a perimeter of cushion supporting elements easily repositionable around portable computer 12, by the user, through releasably attaching hook and loop fasteners or the like. FIG. 2 is a cut-away view, in perspective, of carrying case 10 showing first and a second adjustable three segment cushions 14, 16 coupled to bottom wall 28 and positioned apart, with first three segment cushion 14 positioned against and coupled to the inside surface of left side wall 22 and second three segment cushion 16 positioned against and coupled to the inside surface of right side wall 24. FIG. 3 is a cut-away view, in perspective, of carrying case 10 showing the adjustable, three segment cushions 14, 16 positioned closer to one another, with first cushion 14 positioned against and coupled to the inside surface of left side wall 22 and second cushion 16 spaced apart from the inside surface of right side wall 24 and closer to first cushion 14, with both cushions 14, 16 coupled to bottom wall 28. The interior compartment 11 of case 10 includes fastener elements such as Velcro™ style loops, or felt surfaces, for coupling with Velcro™ style hooks carried on the adjustable cushions 14, 16 or vice versa. It is to be understood that nearly any kind of releasable cooperative fastener elements could be employed in releasably fastening the adjustable cushions 14, 16 within the compartment 11. For example, the cushions 14,16 could carry any of a variety of fastening elements such as buttons for engaging any of several button holes in the compartment; the cushions 14,16 could carry snaps for engaging any of several cooperating snap receiving elements in the compartment, or the cushions 14,16 could carry screws for engaging any of several threaded holes in the compartment 11. Turning now to FIGS. 4, 5 and 6, there is illustrated a three segment, user positionable, adjustable impact resistant cushion (e.g., 14) including a first pad 40, a second pad 42 and a third pad 44, each mounted upon a flexible substrate 46 fabricated from a pliable non-porous plastic and hingedly connecting pads 40, 42 and 44 together at a first hinge 45 and a second hinge 47, respectively. Each pad 40, 42, 44 includes a substantially box-shaped foam piece preferably made from open-cell urethane foam and is enclosed within a pliable non-porous plastic cover 48 which envelops and contiguously covers the foam piece. Each of the pads 40, 42, 44 includes first and second nozzles or vents 50 (as best seen in FIG. 6) providing a conduit in fluid communication with the atmosphere and permitting controlled escape of air from the foam material of each pad when the pad is compressed. In each pad made in accordance with the present invention, non-porous cover 48 is breached only through vent 50 which restricts the flow of air into and out of the open cell foam piece within. Thus, each pad acts like a shock absorber or dashpot and the force required to compress the pad is a function of the speed of compression. As shown in FIGS. 5 and 6, first, second and third pads 40, 42, 44 have the same width of approximately one and one half inches. Third pad 44 has a thickness of one and one half inches while second and third pads 40, 42 each have a thickness of three quarters of an inch. The length of first pad 40 is three and one quarter inches; the length of second pad 42 is ten and one half inches, and the length of third pad 44 is four and three quarter inches. As seen in FIG. 6, the top surface of each pad 40, 42, 44 is stippled with a periodic two-dimensional array of frictionally engaging surface features or dimples 51. Flexible substrate 46 carries four fastener elements in the form of patches of hooks 52, or loops for engagement with the interior of compartment 11. Preferably, at least one fastener element 52 is disposed on either side of each hinge 45, 47. FIG. 4 is a side view of the impact resistant adjustable cushion (e.g. 14), in which the three pads 40, 42, 44 are oriented in a "C" shape; the hinges 45, 47 are bent at an angle of approximately ninety degrees from the straightened orientation of FIG. 5; bend angles of greater than ninety degrees are possible. FIG. 7 is a cut-away view, in perspective, of a luggage insert or receptacle 60 illustrating the position of the segmented cushions 14, 16 in a spaced apart orientation. Luggage insert 60 preferably includes a left side wall 62 opposing a right side wall 64 and proximate to a front wall 66 (not shown) opposite a back wall 68 and a top side wall 72 opposite a bottom side wall 70. Front and back walls 66, 68, left and right side walls 62, 64 and bottom and top side walls 70, 72 can have any desired configuration for defining boundaries of an enclosed compartment 74 in a suitable size for holding a portable computer or the like and, as thus far described, form an insert or receptacle to be inserted within a carrying case or luggage, such as carrying case 10. Luggage insert 60 is fabricated of leather, fabric or a synthetic fabric such as ballistic nylon and typically includes one or more padded stiffening panels encased by the fabric material forming the outer covering. An adjustable support system comprises first adjustable impact resistant cushion 14 and second adjustable impact resistant cushion 16 fastened to an interior surface of compartment 74 to define a perimeter of cushion supporting elements easily repositionable around a portable computer or other instrument, by the user, through releasably attaching hook and loop fasteners or the like. FIG. 7 shows the adjustable cushions 14, 16 positioned apart with first cushion 14 positioned against the inside surface of left side wall 62 and second cushion 16 positioned against the inside surface of right side wall 26. FIG. 8 is a cut-away view, in perspective, of luggage insert 60 showing the adjustable cushions 14, 16 positioned closer to one another, with first cushion 14 positioned against the inside surface of left side wall 62 and second cushion 16 spaced apart from the inside surface of right side wall 64 and closer to first cushion 14. The interior compartment 74 of luggage insert 60 is accessible through a hinged side wall with a releasable clasp closure or the like (not shown) and, within compartment 74, includes a fastener element such as Velcro™ style loops, or a felt surface, for coupling with Velcro™ style hooks carried on the adjustable cushions 14, 16 or vice versa. It is to be understood that nearly any kind of releasable cooperative fastener element could be employed in releasably fastening the adjustable cushions 14, 16 within the compartment 74. Luggage insert or receptacle 60 could be integrally made as part of a carrying case, could be formed as a pouch or have one or more carrying handles, a shoulder strap, or the like. FIG. 9 is a cut-away view, in perspective, of a second embodiment of the carrying case 80 having an interior compartment 82, showing spaced apart positioning of a second embodiment of the user positionable, adjustable, impact resistant cushions 84, 86. Carrying case 80, according to the present invention, includes a front wall 110 opposing a back wall 112, left and right opposing side walls 114 and 116, and top and bottom side walls 118 and 120. The top, bottom, left and right side walls extend between front wall 110 and back wall 112 to form a generally rectangular frame with a zippered opening 122 substantially intermediate front and back edges of the left, right and top side walls to selectively close or open case 80 and allow access to interior compartment 82. In the closed condition shown in FIG. 9, front wall 110, back wall 112, left and right side walls 114, 116, and top and bottom side walls 118, 120 cooperate to define the boundaries of an enclosed compartment 82 which is adapted for receiving a laptop, notebook or sub-notebook sized portable computer (e.g., 12, not shown) or other delicate instrument and/or object, for transportation or storage. Preferably, at least one handle 124 is attached to front wall 110, back wall 112 or top side wall 118 forming an elevated loop for grasping with one hand to transport case 80, and an elongate, flexible webbing shoulder strap 126 is optionally detachably attachable, for ease of carry. An elongate substantially planar partition 128 (shown partially cut away) within compartment 82 is used to provide a stabilizing lateral support or boundary and extends from left side wall 114 to right side wall 116, and optionally from top side wall 118 to bottom side wall 120. Front and back walls 110, 112, left and right side walls 114, 116 and top and bottom side walls 118, 120 can have any desired configuration for defining boundaries of compartment 82 in a suitable size for holding a portable computer or the like and, as thus far described, form a carrying case of the type commonly referred to as an attache or portfolio. Carrying case 80 is preferably fabricated of leather, fabric or a synthetic fabric such as polyester or ballistic nylon and includes padded stiffening panels encased by the fabric material forming the outer covering. An adjustable support system in accordance with the present invention comprises a first user positionable, adjustable, impact resistant, two segment cushion 84 and a second user positionable, adjustable, impact resistant, two segment cushion 86 fastened to an interior surface of compartment 82 to define a perimeter of supporting elements easily repositionable around a portable computer or other instrument, by the user, through releasably attaching hook and loop fasteners or the like. FIG. 9 is a cut-away view, in perspective, of carrying case 80 showing the adjustable cushions 84, 86 positioned apart with first cushion 84 positioned against the inside surface of left side wall 114 and second cushion 86 positioned against the inside surface of right side wall 116. FIG. 10 is a cut-away view, in perspective, of carrying case 80 showing the adjustable cushions 84, 86 positioned closer to one another, with first cushion 84 positioned against the inside surface of left side wall 114 and second cushion 86 positioned spaced apart from the inside surface of right side wall 116 and closer to first cushion 84. The interior compartment 82 of case 80 includes at least one fastener element such as a patch bearing an array of Velcro™ style loops, or a felt surface, for coupling with Velcro™ style hooks carried on the adjustable cushions 84, 86 or vice versa. It is to be understood that nearly any kind of releasable cooperative fastener element could be employed in releasably fastening the adjustable cushions 84, 86 within the compartment 82. FIG. 11 is a top view of an adjustable, user positionable, impact resistant, two segment cushion (e.g., 86) with first and second opposing flexible outwardly extended fastener tabs 140, 142. Adjustable impact resistant cushion 86 has a substantially planar backing 144 (as shown in FIGS. 12, 13 and 14) having a first leg or resilient support member 146 connected at a distal end 148 to the end of a first pad 150 and hingedly connected at a proximal end in hinge 152 to a proximal end of a second leg or support member 154 which is connected at its distal end 156 to the opposite end of a second pad 158, thereby forming two hinged pieces attached only at the distal ends. Backing 146 preferably includes a substantially planar, resilient, flexible, plastic core wrapped in a sewn-on felt covering, and backing hinge 152 is a weakened region perforated by stitching running through the felt covering. In this embodiment of the adjustable, impact absorbing cushion 86, a releasable hook and loop fastener element 160 (e.g., a patch bearing an array of hooks) is carried on the back of the second leg 154. As noted above, cushion 86 also carries first and second fastener tabs 140, 142 upon first support leg 146, the tab 140 being shown bent from the support 146 in FIGS. 12-14. Adjustable impact resistant cushion 86 includes first pad 150 and a second pad 158, each mounted upon a flexible substrate 162 fabricated from a pliable non-porous plastic and hingedly connecting the pads together at a second hinge 164. Backing hinge 152 and second hinge 164 are aligned to bend cooperatively together when the entire cushion 86 is flexed to form an L-shape, as in FIG. 13. Each pad 150, 158 is enclosed within a pliable non-porous cover 166 which envelops and contiguously covers pad foam pieces preferably made from open-cell urethane foam. Each of the pads 150, 158 includes first and second nozzles or vents 168, similar to vent 50, providing a conduit permitting controlled escape of air from the foam material of each pad when the pad is compressed. In each pad 150, 158, non-porous cover 166 is breached only through at least one vent 168 which restricts the flow of air into and out of the open cell foam piece within. Thus, as above, each pad acts like a shock absorber or dashpot and the force required to compress the pad is a function of the speed of compression. As shown in FIG. 11, first and second pads 150, 158 have the same width of approximately one and seven eighths inches. As shown in FIG. 12, second pad 158 has a thickness of one and one half inches while first pad 150 has a thickness of three quarters of an inch. The length of first pad 150 is eight and one half inches, and the length of second pad 158 is five inches. As seen in FIG. 11, the top surface of each pad 150, 158 is stippled with a periodic two-dimensional array of surface features or dimples 170. FIG. 14 is a side view of adjustable cushion 86, showing that the backing member 144 can be pulled away from the flexible substrate 162 bearing first and second pads 150, 158 to form a parallelogram. FIG. 15 is a top view of user positionable, adjustable, impact resistant, two segment cushion 84 which is substantially identical to cushion 86 except for lacking the flexible fastener tabs 140, 142 found on cushion 86. For purposes of nomenclature, cushion 86 (of FIGS. 11-14) shall be identified as the movable cushion and cushion 84 (of FIGS. 15-18) shall be identified as the fixed cushion. Fixed cushion 84 includes a patch bearing hook or loop fastener elements 160 on first leg 146 of backing 144 (instead of the tabs); in all other respects, fixed cushion 84 and movable cushion 86 are identical. FIG. 16 is a side view of the fixed cushion 84, and FIG. 17 is a side view of fixed cushion 84 arranged in an L-shape. FIG. 18 is a side view of fixed cushion 84, with the backing member 144 spaced apart from the flexible substrate 162 to form a parallelogram. Turning now to FIG. 19, a luggage insert or receptacle 174 adapted to be carried alone or within a carrying case has an interior compartment 176 in which are disposed a fixed two segment cushion 84 and a movable two segment cushion 86, in a spaced apart orientation. Luggage insert 174 preferably includes a left side wall 178 opposing a right side wall 180 and proximate to a front wall 182 (not shown), which is opposite a back wall 184 and, optionally, a top side wall 186 (not shown) opposite a bottom side wall 188. Front and back walls 182, 184, left and right side walls 178, 180 and top and bottom side walls 186, 188 can have any desired configuration for defining boundaries of a pocket or compartment 176 in a suitable size for holding a portable computer or the like and, as thus far described, form an insert or receptacle to be inserted within a carrying case or luggage, such as carrying case 10. Luggage insert 174 is fabricated of leather, fabric or a synthetic fabric such as ballistic nylon and can include one or more padded stiffening panels encased by the fabric material forming the outer covering. An adjustable support system comprises fixed cushion 84 and moveable cushion 86 fastened to an interior surface of compartment 176 to define a three sided perimeter of supporting elements easily repositionable around a portable computer, by the user, through releasably attaching hook and loop fasteners or the like. FIG. 19 shows the adjustable cushions 84, 86 positioned apart with fixed cushion 84 positioned against the inside surface of left side wall 178 and moveable cushion 86 positioned against the inside surface of right side wall 180. Hook fastener elements 160 on the second pads 158 of both cushions 84, 86 are releasably coupled to bottom wall 188. First fastener tab 140 and second fastener tab 142 of moveable cushion 86 are coupled to back wall 184 and front wall 182 (not shown), respectively. FIG. 20 is a cut-away view, in perspective, of luggage insert 174 showing the adjustable cushions 84, 86 positioned closer to one another, with fixed cushion 84 positioned against the inside surface of left side wall 178 and movable cushion 86 positioned with first leg 146 spaced apart from the inside surface of right side wall 180 and closer to fixed cushion 84. The position of first leg 146 of movable cushion 86 is supported by first fastener tab 140 and second fastener tab 142 which are coupled to back wall 184 and front wall 182 (not shown), respectively. The second pad segments 158 of both adjustable cushions 84, 86 are coupled to the interior surface of bottom wall 188, once the cushion fastener elements 160 are brought into contact therewith, thus placing the thicker pads upon the bottom wall, for greatest protection against shock from drops. The interior compartment 176 of luggage insert 174 is accessible through the open top end as shown in FIGS. 19 and 20, or, if the optional top side wall 186 is present, a hinged side wall with a releasable clasp closure or the like (not shown) provides access. Compartment 176 includes one or more fastener elements such as Velcro™ style loops, or a felt surface, for coupling with Velcro™ style hooks carried on the adjustable cushions 84, 86 or vice versa. It is to be understood that nearly any kind of releasable cooperative fastener element could be employed in releasably fastening the adjustable cushions 84, 86 within the compartment 176. Luggage insert or receptacle 174 could be integrally made as part of a carrying case or could have one or more carrying handles, or the like. FIG. 21 is a side view of compartment 176 within luggage insert 174, showing a spaced apart and vertical orientation of the adjustable cushions 84, 86, as in FIG. 19. Many angular orientations are possible when positioning movable cushion 86; FIG. 22 is a side view of compartment 176 showing an angled orientation for the movable adjustable cushion 86 in which the second pad 158 is laterally displaced (to be more closely spaced to the second pad 158 of fixed cushion 84) and first pad 150 of cushion 86 is disposed at an acute angle (with respect to second pad 158). FIG. 23 is a side view of compartment 176 showing another angled orientation for the movable adjustable cushion 86 in which the second pad 158 thread is laterally displaced (to be even more closely spaced to the second pad 158 of fixed cushion 84) and first pad 150 of cushion 86 is disposed at an obtuse angle (with respect to second pad segment 158). FIGS. 22 and 23 illustrate that the adjustable cushions 84, 86 can be positioned to provide a protective perimeter of impact resistance for instruments having a wide variety of shapes and sizes. Alternatively, an adjustable support system comprises first and second opposing moveable cushions (e.g., 86) fastened to the interior surfaces of a compartment (e.g., 176) to define a three sided perimeter of repositionable supporting elements readily repositioned by the user, through releasably attaching hook and loop fastener arrays 140, 142. From the above, it will be appreciated that the carrying case and the user-positionable impact resistant cushions of the present invention can be used to provide a closely fitted perimeter of support to protect a portable computer during transport or storage. The carrying case or luggage insert compartment (e.g., 176) has a lineal dimension (e.g., 190, along the bottom wall 188 as shown in FIG. 22) greater than the combined dimensions of the pad segments (e.g., 158) of the first and second cushions when positioned upon and coupled with the compartment wall. The user may position the adjustable cushions in any manner to provide a perimeter of a wide range of widths or having irregular, non-parallel sides. As used herein, "portable" computer refers to any computing device reduced in size and weight as to be carried and employed while traveling, or any other delicate instrument which will fit within the compartment of the case. By "adjustable cushion" is meant a cushion which may include a flexible hinge or other flexible, bendable or changeable feature permitting the cushion to be converted to a selected shape. By "user positionable" is meant that the individual cushions can be removed, uncoupled or unfastened and replaced in a different position and/or angular orientation. The impact resistant cushions disclosed as examples above are adjustable, but a carrying case or luggage insert in accordance with the present invention need not include adjustable cushions; instead, user positionable cushions having a single pad can be releasably fastenable within the compartment; a plurality of such cushions can be fastened individually to define a protective perimeter for a portable computer, or the like. By "non-porous" is meant substantially impermeable to air, so that, during compression, the great majority of air is expelled from a pad through the vent. By "pliable" is meant deformable in response to force generated by a decelerating computing device or instrument stored or carried in the case or luggage insert. The vented pads disclosed in the examples given above include urethane foam pieces, but other shock absorbing and highly compressible materials which will readily expel air through the vents, upon compression, can be employed. Further, the cushions of the present invention can include a rigid and unhinged substrate or backing member carrying releasable fastening elements; substitute rigid cushions of a variety of sizes and shapes can be provided to the user so that rigid cushions to fit a user's particular portable computer can be selected and inserted into the carrying case compartment. In as much as the present invention is subject to various modifications and changes in detail, the above description of a preferred embodiment is intended to be exemplary only and not limiting. It is believed that other modifications, variations and changes will be suggested to those skilled in the art in view of the teachings set forth herein. It is therefore to be understood that all such variations, modifications and changes are believed to fall within the scope of the present invention as defined by the appended claims.

An adjustable, impact resistant cushion for use in a carrying case or the like has a first pad including a compressible, substantially rectangular foam piece covered with a pliable non-porous cover. The cover continuously covers the foam piece and includes an air flow controlling vent. Air escapes from the pad through the vent at a controlled rate when the foam material is compressed and so the pad absorbs shock by providing resistance to compression which increases with increasing compression velocity. Preferably, open cell urethane foam is employed in the compressible foam piece. The adjustable impact resistant cushion includes a second pad hingedly connected by a flexible hinge segment of webbing or plastic. The adjustable cushion includes, on a back surface, one or more releasable hook and loop type fasteners elements (e.g., either hooks or loops). Preferably, two of the impact resistant cushions are used in a luggage insert (for insertion into a carrying case or other luggage) or are incorporated directly into the interior portion of a carrying case having compartment with an interior surface covered with felt or loop material for attachment using hook fasteners carried by the adjustable cushions. An adjustable cushion may also carry one or more flexible tabs extending outwardly from the cushion pad major axis and so can be positioned in cushion pairs at selected separations and angular orientations, thereby accommodating portable computers having different widths.

BACKGROUND OF THE INVENTION This invention relates generally to bridges for retention sutures and, more particularly, to suture bridges which are spaced from the incision and which distribute pressure over a relatively large area adjacent the incision. During surgical operations, particularly in the abdominal region, large incisions are frequently made. In order to promote the healing of these incisions, one or more retention sutures are provided along the length of the wound. A curved needle draws the suture thread down through the skin and layers of tissue on one side of the incision and then upwardly through the same layers piercing the skin on the opposite side of the incision. The two ends of the suture extending from the skin on either side of the incision are joined under tension thereby drawing the tissue together to promote healing. Various bridging devices have been proposed to prevent the suture thread from being impressed into the skin and under-lying tissues when the suture is formed due to the transverse tension exerted on the incision by suture thread. One current technique in use comprises passing the ends of the suture thread through opposite ends of a length of plastic tubing which may have a telescoping construction so that its length may be varied to approximate the distance between the exit points of the suture thread from the body. However, although the pressure of the suture thread is somewhat more widely distributed over the skin in the vicinity of the incision than is the case where no tube is employed, the tube overlies and contacts the skin and the incision and does not necessarily prevent necrosis. Various other bridging elements have been used to provide fastening points for retention sutures. Wide plastic strips having a plurality of spaced openings such as that shown in U.S. Pat. No. 3,650,274, granted March 21, 1972, have been suggested. However, the incision becomes inaccessible since the bridge maintains contact with the skin along its entire length. Arch-type bridges wherein the bridge ends contact the skin in localized areas on either side of the incision, such as that shown in U.S. Pat. No. 3,695,271 granted Oct. 3, 1972, while alleviating pressure in the immediate vicinity of the incision, concentrate the pressure beneath the points of contact of the bridge ends. Thus, it is seen that a dual problem exists with retention suture bridges currently used, namely, excessive pressure on the skin in the vicinity of the incision and lack of accessibility to the incision itself while the bridge is in position. SUMMARY OF THE INVENTION Accordingly, one object of the present invention is to provide a new and improved bridge assembly for retention sutures. Another object of the present invention is to provide a new and improved bridge assembly which reduces the pressure on the skin resulting from its placement in the vicinity of the incision. Still another object of the present invention is to provide a retention suture bridge of the above type which allows for free accessibility to all parts of the incision and to the area surrounding it. Briefly, in accordance with the invention, these and other objects are attained by providing a pair of elongate, flexible strips preferably formed of a plastic material, each strip to be located on a respective side of an incision substantially parallel to it. Each strip has a plurality of openings formed along its length which mount the respective ends of an arch-shaped bridge. A number of bridges may be located along the length of the incision mounted in the same pair of strips. Thus, the pressure exerted by the ends of each bridge is transmitted to the long strips which distribute it evenly along its entire area while the arch construction permits free access to the area immediately surrounding the incision. The flexibility of the strip allows for compensatory distribution of pressure during breathing, coughing, etc. DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of the bridge assembly of the present invention illustrated during the suturing of an incision; FIG. 2 is a plan view of the pressure distribution members of the assembly; FIG. 3 is a front view in partial section of the bridge assembly along lines 3--3 of FIG. 1; FIG. 4 is a plan view of a portion of a bridge and associated suture thread; FIG. 4A is a perspective view of a pressure distribution member with an expanded foam layer fixed to one of its surfaces; FIG. 5 is an elevation view in section of a portion of another embodiment of a bridge; FIG. 6 is a sectional view of the bridge taken along line 6--6 of FIG. 5; FIG. 7 is a sectional view of the bridge taken along line 7--7 of FIG. 5; and FIG. 8 is a plan view of a portion of a bridge and associated suture. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings wherein like reference characters designate identical or corresponding parts throughout the several views, the bridge assembly, generally denoted as 10, includes at least one bridge 12 (three shown in FIG. 1) which spans an incision 14 in a substantially transverse manner and a pair of pressure distributing members 16 and 18. As best seen in FIG. 3, the ends of a bridge 12 are fastened to respective pressure distributing members which themselves rest upon the skin 20 of the patient whose incision is being sutured. Referring to FIG. 1, it is understood that as more suture loops are sewn to close the incision, an equal number of bridges will be added to the assembly along the length of the incision 14. Referring to FIGS. 3 and 4, the suture bridge 12 comprises a generally U-shaped member preferably molded of a relatively rigid thermoplastic material. The bridge also preferably has a substantially U-shaped cross section defined by a bottom wall 22 having an arched cross section (similar to the one shown in FIG. 6) and a pair of side walls 24, 26 formed along its peripheral edges. A plurality of spaced apertures 28 are formed in bottom wall 22 on both sides of the apex of the bridge through which suture thread 30 may be passed as will be described in greater detail below. As described below in connection with FIG. 6, it is desirable to form bottom wall 22 with a generally arch-shape construction and with apertures 28 formed having a tapered construction to facilitate the passing of the suture thread through the apertures. A pair of posts 32, 34 are formed in bridge side walls 24, 26 respectively, each post having a pair of opposed notches 36 which facilitate securing the end portions of the suture thread 30 to the bridge after they have been threaded through apertures 28. The bottom and side walls of bridge 12 merge together into substantially circularly shaped ends 38, 40 each having an enlarged diameter relative to the bridge. A pin 42 extends from each end which is receivable within a particular opening formed in a pressure distributing member described below. The pressure distributing members 16, 18 comprise a pair of relatively flat, flexible plastic strips of approximately the same length as the particular incision with which they are used. Each pressure distributing member (hereinafter referred to as pressure strips) has a plurality of openings, generally denoted as 44, which extend substantially along the entire length of the strip. Openings 44 are of approximately the same size as pins 42 so that a pin may be snugly received in a particular opening. Referring to FIG. 2, it is seen that the centers of a first set of alternate openings 46 define a longitudinal axis 48 on each strip. The other or second set of alternate openings 50 in the preferred embodiment are uniformly spaced a predetermined distance to one side of axis 48 for a reason which will become clear when the operation of the bridge assembly is described below. Although the structure of the pressure distributing members is preferred as described above, it is understood that the essential characteristics of these members are that they present a surface area relatively greater than the area of a bridge end and that some means are provided to fasten a bridge end to it. Thus other shapes and sizes of these members are possible within the scope of this invention. The operation of the bridge assembly will now be described. When an incision such as incision 14 (FIG. 1) is about to be closed after completion of surgery, a pair of pressure strips 16, 18 are placed on the skin on opposite sides of and generally parallel to incision 14. It is usually the case that the bridge assembly will be situated on the skin for an extended length of time, i.e. up to two weeks. Under these circumstances, it is desirable to interpose a layer of expanded foam between the strip and the skin to assure that the skin directly beneath the strip will have access to air. As shown in FIG. 4A, the foam 100 might be adhesively fastened on the underside of each plate 16. Alternatively, the foam layer might be supplied separately from the plate. The surgeon then threads the suture thread 30 through the incision at one point along its length, takes a bridge 12 and inserts the pin 42 of bridge end 38 into the particular opening 46 in pressure strip 16 nearest to one exit point of the suture thread from the skin. The pin 42 on the other bridge end 40 is then aligned with an opening 46 on the other pressure strip 18 and inserted in it. The snug fit of the pins within the openings serves to mount the bridge 12 in position over the incision. The lower surface of bridge ends 38, 40 presents a shoulder which bears against the upper surface of each pressure strip. The enlarged configuration of each end serves to distribute the pressure of the bridge on the strip itself in addition to promoting the stability of the bridge as mounted. Referring to FIG. 3, the suture thread may be crossed beneath the bridge as shown and the ends passed through appropriate apertures 28 in the bottom wall 22 of bridge 12. Each end of the suture thread extending through the apertures is then looped around a respective post 32, 34 and knotted together as at 52 (FIG. 4). The thread is preferably looped around the posts several times prior to knotting to facilitate the splice and also to provide a reserve of suture material should the knot have to be cut during readjustment of the suture. The suture draws the opposed sides of incision 14 together to promote healing, and the arch-shaped configuration of bridge 12 permits easy accessibility to incision 14 and suture thread 30. The pressure exerted on the bridge by suture thread 30 is evenly transmitted by bridge ends 38, 40 to the pressure strips 16, 18 and evenly distributed over their relatively large area. As further suture loops are added along the length of the incision, additional bridges are mounted on the pressure strips and the pressure is transmitted from the ends of these bridges to the pressure strips which evenly distribute it over the relatively larger area. The distance between opposed openings 46 on respective pressure strips 16, 18 defines a predetermined fixed distance equal to the distance between pins 42 on any one bridge. Each opening 50 laterally spaced relative to an adjacent opening 46 lies on an arc described through that opening 46 having a radius of curvature equal to the distance between the pins 42 on the bridge and whose center is the opposed opening 46 formed in the other pressure strip. For example, referring to FIG. 2 openings 100, 102 and 104 on pressure strip 18 all lie on the same arc having a radius of curvature R equal to the distance between pins 42 on a bridge with the center being opening 106 on strip 16. The reason for this structure is that occasionally the ends of the suture thread 30 exiting from the skin on either side of the incision are not precisely aligned with a pair of opposed openings 46 in respective pressure strips. In such circumstances, it is desirable to still have the bridge directly positioned over the suture loop. By so forming two sets of alternate openings 46, 50, the bridge 12 may be canted at an angle as illustrated by bridge 52 in FIG. 1 and still directly overlie the displaced suture loop. Referring to FIGS. 5 through 8, another embodiment of a suture bridge is illustrated. The bridge 12' has substantially the same U-shaped cross section as bridge 12. Referring to FIG. 6, the bottom wall 22' has an arch-shaped cross section while apertures 28' are tapered upwardly. Such structure facilitates the threading of the suture thread 30 through the aperture since the bottom wall 22' tends to position the point of the needle towards the apex of the arch where the aperture is formed. In lieu of posts 32, 34 a knob 54 is provided, the knob being defined by a shaft 56 extending upwardly from bottom wall 22' terminating in an enlarged head 58. After the suture thread ends are passed through apertures 28', they are looped around shaft 56 and retained there by the shoulder 59 formed on the lower surface of head 58. Obviously, numerous variations and modifications of the present invention are possible in light of the instant disclosure. For example, the pins and openings 42 and 44 respectively may be reversed so that the pressure strips have a series of upwardly extending pins while the bridge ends have openings formed in them. Other types of fasteners may be used to mount the bridge ends on the pressure strips. Further, the pressure distributing members may have different shapes than as shown and the openings 44 may be positioned otherwise than as shown. 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.

An assembly of bridges for retention sutures to be spaced along the length of a surgical incision, each bridge having an arched configuration so as to be spaced from the incision so that the healing of the wound is facilitated while affording a physician access to the incision. The ends of each bridge do not contact the skin but are associated with respective ones of a pair of flat mounting strips positioned on either side of the incision which distribute the pressure exerted by the bridge ends from the sutures evenly over a relatively large area.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of U.S. application Ser. No. 11/978,066, filed Oct. 26, 2007; which is a divisional of U.S. application Ser. No. 10/939,630, filed Sep. 13, 2004, now U.S. Pat. No. 7,306,594; which is a divisional of U.S. application Ser. No. 09/845,022, filed Apr. 27, 2001, now U.S. Pat. No. 6,837,886; all of which are entitled APPARATUS AND METHODS FOR MAPPING AND ABLATION IN ELECTROPHYSIOLOGY PROCEDURES, all of which are hereby incorporated herein by reference in their entirety, and which, in turn, claim the benefit of U.S. Provisional Application Ser. No. 60/261,015 entitled HIGH DENSITY MAPPING AND ABLATION CATHETER AND METHOD OF USE, filed Jan. 11, 2001; U.S. Provisional Application Ser. No. 60/204,457 entitled METHOD FOR CREATING ANNULAR EPICARDIAL LESIONS AT THE OSTIA OF THE PULMONARY VEINS, filed on May 16, 2000; U.S. Provisional Application Ser. No. 60/204,482 entitled METHOD AND DEVICE FOR CREATING ANNULAR ENDOCARDIAL LESIONS AT THE OSTIA OF THE PULMONARY VEINS, filed May 16, 2000; and U.S. Provisional Application Ser. No. 60/201,445 entitled TRANSMURAL CIRCUMFERENTIAL LESIONS MADE AT CANINE PV OSTIUM BY EXPANDABLE MESH ELECTRODES IN VIVO, filed May 3, 2000, all of which are also hereby incorporated herein by reference in their entirety. BACKGROUND OF THE INVENTION [0002] The human heart is a very complex organ, which relies on both muscle contraction and electrical impulses to function properly. The electrical impulses travel through the heart walls, first through the atria and then the ventricles, causing the corresponding muscle tissue in the atria and ventricles to contract. Thus, the atria contract first, followed by the ventricles. This order is essential for proper functioning of the heart. [0003] Over time, the electrical impulses traveling through the heart can begin to travel in improper directions, thereby causing the heart chambers to contract at improper times. Such a condition is generally termed a cardiac arrhythmia, and can take many different forms. When the chambers contract at improper times, the amount of blood pumped by the heart decreases, which can result in premature death of the person. [0004] Techniques have been developed which are used to locate cardiac regions responsible for the cardiac arrhythmia, and also to disable the short-circuit function of these areas. According to these techniques, electrical energy is applied to a portion of the heart tissue to ablate that tissue and produce scars which interrupt the reentrant conduction pathways or terminate the focal initiation. The regions to be ablated are usually first determined by endocardial mapping techniques. Mapping typically involves percutaneously introducing a catheter having one or more electrodes into the patient, passing the catheter through a blood vessel (e.g. the femoral vein or artery) and into an endocardial site (e.g., the atrium or ventricle of the heart), and deliberately inducing an arrhythmia so that a continuous, simultaneous recording can be made with a multichannel recorder at each of several different endocardial positions. When an arrythormogenic focus or inappropriate circuit is located, as indicated in the electrocardiogram recording, it is marked by various imaging or localization means so that cardiac arrhythmias emanating from that region can be blocked by ablating tissue. An ablation catheter with one or more electrodes can then transmit electrical energy to the tissue adjacent the electrode to create a lesion in the tissue. One or more suitably positioned lesions will typically create a region of necrotic tissue which serves to disable the propagation of the errant impulse caused by the arrythromogenic focus. Ablation is carried out by applying energy to the catheter electrodes. The ablation energy can be, for example, RF, DC, ultrasound, microwave, or laser radiation. [0005] Atrial fibrillation together with atrial flutter are the most common sustained arrhythmias found in clinical practice. [0006] Current understanding is that atrial fibrillation is frequently initiated by a focal trigger from the orifice of or within one of the pulmonary veins. Though mapping and ablation of these triggers appears to be curative in patients with paroxysmal atrial fibrillation, there are a number of limitations to ablating focal triggers via mapping and ablating the earliest site of activation with a “point” radiofrequency lesion. One way to circumvent these limitations is to determine precisely the point of earliest activation. Once the point of earliest activation is identified, a lesion can be generated to electrically isolate the trigger with a lesion; firing from within those veins would then be eliminated or unable to reach the body of the atrium, and thus could not trigger atrial fibrillation. [0007] Another method to treat focal arrhythmias is to create a continuous, annular lesion around the ostia (i.e., the openings) of either the veins or the arteries leading to or from the atria thus “corralling” the signals emanating from any points distal to the annular lesion. Conventional techniques include applying multiple point sources around the ostia in an effort to create such a continuous lesion. Such a technique is relatively involved, and requires significant skill and attention from the clinician performing the procedures. [0008] Another source of arrhythmias may be from reentrant circuits in the myocardium itself. Such circuits may not necessarily be associated with vessel ostia, but may be interrupted by means of ablating tissue either within the circuit or circumscribing the region of the circuit. It should be noted that a complete ‘fence’ around a circuit or tissue region is not always required in order to block the propagation of the arrhythmia; in many cases simply increasing the propagation path length for a signal may be sufficient. Conventional means for establishing such lesion ‘fences’ include a multiplicity of point-by-point lesions, dragging a single electrode across tissue while delivering energy, or creating an enormous lesion intended to inactivate a substantive volume of myocardial tissue. [0009] Commonly-owned U.S. patent application Ser. No. 09/396,502, entitled Apparatus For Creating A Continuous Annular Lesion, which is hereby incorporated by reference, discloses a medical device which is capable of ablating a continuous ring of tissue around the ostia of either veins or arteries leading to or from the atria. SUMMARY OF THE INVENTION [0010] The present invention encompasses apparatus and methods for mapping electrical activity within the heart. The present invention also encompasses methods and apparatus for creating lesions in the heart tissue (ablating) to create a region of necrotic tissue which serves to disable the propagation of errant electrical impulses caused by an arrhythmia. [0011] In one embodiment, the present invention includes a medical device including a catheter having a braided conductive member at a distal end thereof, a mechanism for expanding the braided conductive member from an undeployed to a deployed position, and a mechanism for applying energy via the braided conductive member to blood vessel. [0012] In one embodiment, the medical device further includes a mechanism for irrigating the braided conductive member. [0013] In another embodiment, the medical device further includes at least one reference electrode disposed on a shaft of the catheter. [0014] In another embodiment, the medical device includes a mechanism for controlling the energy supplied to the braided conductive member. [0015] In another embodiment, the medical device further includes a mechanism for covering at least a portion of the braided conductive member when the braided conductive member is in the deployed position. [0016] In another embodiment, at least a portion of the braided conductive member has a coating applied thereto. [0017] In another embodiment, the medical device includes a mechanism for measuring temperature. [0018] In another embodiment, the medical device includes a mechanism for steering the catheter. [0019] The invention also includes a method for treating cardiac arrhythmia, including the steps of introducing a catheter having a braided conductive member at a distal end thereof into a blood vessel, expanding the braided conductive member at a selected location in the blood vessel so that the braided conductive member contacts a wall of the blood vessel, and applying energy to the wall of the blood vessel via the braided conductive member to create a lesion in the blood vessel. [0020] In another embodiment, the invention includes a method for treating cardiac arrhythmia, including the steps of introducing a catheter into a thoracic cavity of a patient, the catheter having a braided conductive member at a distal end thereof, contacting an exterior wall of a blood vessel in a vicinity of an ostium with the braided conductive member, and applying energy to the blood vessel via the braided conductive member to create a lesion on the exterior wall of the blood vessel. [0021] Another embodiment described herein relates to a method for treating a condition of a patient. The method comprises acts of introducing a portion of a catheter into a patient, the catheter having a braided conductive member at a distal end thereof, contacting an exterior wall of a blood vessel with the braided conductive member, and applying energy to the exterior wall via the braided conductive member to treat the condition. [0022] A further embodiment described herein relates to a method comprising an act of introducing a portion of a catheter into a patient, the catheter having a braided conductive member at a distal end thereof. The braided conductive member comprises a plurality of filaments. The method also comprises acts of contacting a wall of a blood vessel with the braided conductive member and energizing at least some of the plurality of filaments to apply energy to the wall via the braided conductive member. The method further comprises acts of sensing, during the act of energizing, at least one temperature using at least one temperature sensor coupled to the braided conductive member; and controlling energy delivery to the braided conductive member based on the at least one sensed temperature. [0023] The braided conductive member may be a wire mesh. [0024] The features and advantages of the present invention will be more readily understood and apparent from the following detailed description of the invention, which should be read in conjunction with the accompanying drawings, and from the claims which are appended at the end of the Detailed Description. BRIEF DESCRIPTION OF THE DRAWINGS [0025] In the drawings, which are incorporated herein by reference and in which like elements have been given like references characters, [0026] FIG. 1 illustrates an overview of a mapping and ablation catheter system in accordance with the present invention; [0027] FIGS. 2 and 3 illustrate further details of the catheter illustrated in FIG. 1 ; [0028] FIGS. 4-7 illustrate further details of the braided conductive member illustrated in FIGS. 2 and 3 ; [0029] FIGS. 8-10A illustrate, among other things, temperature sensing in the present invention; [0030] FIGS. 11-13 illustrate further details of the steering capabilities of the present invention; [0031] FIGS. 14-17 illustrate further embodiments of the braided conductive member; [0032] FIGS. 18-19 illustrate the use of irrigation in connection with the present invention; [0033] FIGS. 20A-20E illustrate the use of shrouds in the present invention; [0034] FIG. 21 illustrates a guiding sheath that may be used in connection with the present invention; [0035] FIGS. 22-24 illustrate methods of using the present invention. DETAILED DESCRIPTION System Overview [0036] Reference is now made to FIG. 1 , which figure illustrates an overview of a mapping and ablation catheter system in accordance with the present invention. The system includes a catheter 10 having a shaft portion 12 , a control handle 14 , and a connector portion 16 . A controller 8 is connected to connector portion 16 via cable 6 . Ablation energy generator 4 may be connected to controller 8 via cable 3 . A recording device 2 may be connected to controller 8 via cable 1 . When used in an ablation application, controller 8 is used to control ablation energy provided by ablation energy generator 4 to catheter 10 . When used in a mapping application, controller 8 is used to process signals coming from catheter 10 and to provide these signals to recording device 2 . Although illustrated as separate devices, recording device 2 , ablation energy generator 4 , and controller 8 could be incorporated into a single device. In one embodiment, controller 8 may be a QUADRAPULSE RF CONTROLLER™ device available from CR Bard, Inc., Murray Hill, N.J. [0037] In this description, various aspects and features of the present invention will be described. The various features of the invention are discussed separately for clarity. One skilled in the art will appreciate that the features may be selectively combined in a device depending upon the particular application. Furthermore, any of the various features may be incorporated in a catheter and associated method of use for either mapping or ablation procedures. Catheter Overview [0038] Reference is now made to FIGS. 2-7 , which figures illustrate one embodiment of the present invention. The present invention generally includes a catheter and method of its use for mapping and ablation in electrophysiology procedures. Catheter 10 includes a shaft portion 12 , a control handle 14 , and a connector portion 16 . When used in mapping applications, connector portion 16 is used to allow signal wires running from the electrodes at the distal portion of the catheter to be connected to a device for processing the electrical signals, such as a recording device. [0039] Catheter 10 may be a steerable device. FIG. 2 illustrates the distal tip portion 18 being deflected by the mechanism contained within control handle 14 . Control handle 14 may include a rotatable thumb wheel which can be used by a user to deflect the distal end of the catheter. The thumb wheel (or any other suitable actuating device) is connected to one or more pull wires which extend through shaft portion 12 and are connected to the distal end 18 of the catheter at an off-axis location, whereby tension applied to one or more of the pull wires causes the distal portion of the catheter to curve in a predetermined direction or directions. U.S. Pat. Nos. 5,383,852, 5,462,527, and 5,611,777, which are hereby incorporated by reference, illustrate various embodiments of control handle 14 that may be used for steering catheter 10 . [0040] Shaft portion 12 includes a distal tip portion 18 , a first stop 20 and an inner member 22 connected to the first stop portion 20 . Inner member 22 may be a tubular member. Concentrically disposed about inner member 22 is a first sheath 24 and a second sheath 26 . Also concentrically disposed about inner member 22 is a braided conductive member 28 anchored at respective ends 30 and 32 to the first sheath 24 and the second sheath 26 , respectively. [0041] In operation, advancing the second sheath 26 distally over inner member 22 causes the first sheath 24 to contact stop 20 . Further distal advancement of the second sheath 26 over inner member 22 causes the braided conductive member 28 to expand radially to assume various diameters and/or a conical shape. FIG. 3 illustrates braided conductive member 28 in an unexpanded (collapsed or “undeployed”) configuration. FIGS. 2 and 4 illustrate braided conductive member 28 in a partially expanded condition. FIG. 1 illustrates braided conductive member 28 radially expanded (“deployed”) to form a disk. [0042] Alternatively, braided conductive member 28 can be radially expanded by moving inner member 22 proximally with respect to the second sheath 26 . [0043] As another alternative, inner member 22 and distal tip portion 18 may be the same shaft and stop 20 may be removed. In this configuration, sheath 24 moves over the shaft in response to, for example, a mandrel inside shaft 22 and attached to sheath 24 in the manner described, for example, in U.S. Pat. No. 6,178,354, which is incorporated herein by reference. [0044] As illustrated particularly in FIGS. 4 and 5 a third sheath 32 may be provided. The third sheath serves to protect shaft portion 12 and in particular braided conductive member 28 during manipulation through the patient's vasculature. In addition, the third sheath 32 shields braided conductive member 28 from the patient's tissue in the event ablation energy is prematurely delivered to the braided conductive member 28 . [0045] The respective sheaths 24 , 26 , and 32 can be advanced and retracted over the inner member 22 , which may be a tubular member, in many different manners. Control handle 14 may be used. U.S. Pat. Nos. 5,383,852, 5,462,527, and 5,611,777 illustrate examples of control handles that can control sheaths 24 , 26 , and 32 . As described in these incorporated by reference patents, control handle 14 may include a slide actuator which is axially displaceable relative to the handle. The slide actuator may be connected to one of the sheaths, for example, the second sheath 26 to control the movement of the sheath 26 relative to inner member 22 , to drive braided conductive member 28 between respective collapsed and deployed positions, as previously described. Control handle 14 may also include a second slide actuator or other mechanism coupled to the retractable outer sheath 32 to selectively retract the sheath in a proximal direction with respect to the inner member 22 . [0046] Braided conductive member 28 is, in one embodiment of the invention, a plurality of interlaced, electrically conductive filaments 34 . Braided conductive member 28 may be a wire mesh. The filaments are flexible and capable of being expanded radially outwardly from inner member 22 . The filaments 34 are preferably formed of metallic elements having relatively small cross sectional diameters, such that the filaments can be expanded radially outwardly. The filaments may be round, having a dimension on the order of about 0.001-0.030 inches in diameter. Alternatively, the filaments may be flat, having a thickness on the order of about 0.001-0.030 inches, and a width on the order of about 0.001-0.030 inches. The filaments may be formed of Nitinol type wire. Alternatively, the filaments may include non metallic elements woven with metallic elements, with the non metallic elements providing support to or separation of the metallic elements. A multiplicity of individual filaments 34 may be provided in braided conductive member 28 , for example up to 300 or more filaments. [0047] Each of the filaments 34 can be electrically isolated from each other by an insulation coating. This insulation coating may be, for example, a polyamide type material. A portion of the insulation on the outer circumferential surface 60 of braided conductive member 28 is removed. This allows each of the filaments 34 to form an isolated electrode, not an electrical contact with any other filament, that may be used for mapping and ablation. Alternatively, specific filaments may be permitted to contact each other to form a preselected grouping. [0048] Each of the filaments 34 is helically wound under compression about inner member 22 . As a result of this helical construction, upon radial expansion of braided conductive member 28 , the portions of filaments 34 that have had the insulation stripped away do not contact adjacent filaments and thus, each filament 34 remains electrically isolated from every other filament. FIG. 6 , in particular, illustrates how the insulation may be removed from individual filaments 34 while still providing isolation between and among the filaments. As illustrated in FIG. 6 , regions 50 illustrate regions, on the outer circumferential surface 60 of braided conductive member 28 , where the insulation has been removed from individual filaments 34 . In one embodiment of the invention, the insulation may be removed from up to one half of the outer facing circumference of each of the individual filaments 34 while still retaining electrical isolation between each of the filaments 34 . [0049] The insulation on each of the filaments 34 that comprise braided conductive member 28 may be removed about the outer circumferential surface 60 of braided conductive member 28 in various ways. For example, one or more circumferential bands may be created along the length of braided conductive member 28 . Alternatively, individual sectors or quadrants only may have their insulation removed about the circumference of braided conductive member 28 . Alternatively, only selected filaments 34 within braided conductive member 28 may have their circumferentially facing insulation removed. Thus, an almost limitless number of configurations of insulation removal about the outer circumferential surface 60 of braided conductive member 28 can be provided depending upon the mapping and ablation characteristics and techniques that a clinician desires. [0050] The insulation on each of the filaments 34 may be removed at the outer circumferential surface 60 of braided conductive member 28 in a variety of ways as long as the insulation is maintained between filaments 34 so that filaments 34 remain electrically isolated from each other. [0051] The insulation can be removed from the filaments 34 in a variety of ways to create the stripped portions 50 on braided conductive member 28 . For example, mechanical means such as abration or scraping may be used. In addition, a water jet, chemical means, or thermal radiation means may be used to remove the insulation. [0052] In one example of insulation removal, braided conductive member 28 may be rotated about inner member 22 , and a thermal radiation source such as a laser may be used to direct radiation at a particular point along the length of braided conductive member 28 . As the braided conductive member 28 is rotated and the thermal radiation source generates heat, the insulation is burned off the particular region. [0053] Insulation removal may also be accomplished by masking selected portions of braided conductive member 28 . A mask, such as a metal tube may be placed over braided conducive member 28 . Alternatively, braided conductive member 28 may be wrapped in foil or covered with some type of photoresist. The mask is then removed in the areas in which insulation removal is desired by, for example, cutting away the mask, slicing the foil, or removing the photoresist. Alternatively, a mask can be provided that has a predetermined insulation removal pattern. For example, a metal tube having cutouts that, when the metal tube is placed over braided conductive member 28 , exposes areas where insulation is to be removed. [0054] FIG. 6 illustrates how thermal radiation 52 may be applied to the outer circumferential surface 56 of a respective filament 34 that defines the outer circumferential surface 60 of braided conductive member 28 . As thermal radiation 52 is applied, the insulation 54 is burned off or removed from the outer circumference 56 of wire 34 to create a region 58 about the circumference 56 of filament 34 that has no insulation. [0055] The insulation 54 can also be removed in a preferential manner so that a particular portion of the circumferential surface 56 of a filament 34 is exposed. Thus, when braided conductive member 28 is radially expanded, the stripped portions of filaments may preferentially face the intended direction of mapping or ablation. [0056] With the insulation removed from the portions of filaments 34 on the outer circumferential surface 60 of braided conductive member 28 , a plurality of individual mapping and ablation channels can be created. A wire runs from each of the filaments 34 within catheter shaft 12 and control handle 14 to connector portion 16 . A multiplexer or switch box may be connected to the conductors so that each filament 34 may be controlled individually. This function may be incorporated into controller 8 . A number of filaments 34 may be grouped together for mapping and ablation. Alternatively, each individual filament 34 can be used as a separate mapping channel for mapping individual electrical activity within a blood vessel at a single point. Using a switch box or multiplexer to configure the signals being received by filaments 34 or ablation energy sent to filaments 34 results in an infinite number of possible combinations of filaments for detecting electrical activity during mapping procedures and for applying energy during an ablation procedure. [0057] By controlling the amount of insulation that is removed from the filaments 34 that comprise braided conductive member 28 , the surface area of the braid that is in contact with a blood vessel wall can also be controlled. This in turn will allow control of the impedance presented to an ablation energy generator, for example, generator 4 . In addition, selectively removing the insulation can provide a predetermined or controllable profile of the ablation energy delivered to the tissue. [0058] The above description illustrates how insulation may be removed from a filaments 34 . Alternatively, the same features and advantages can be achieved by adding insulation to filaments 34 . For example, filaments 34 may be bare wire and insulation can be added to them. [0059] Individual control of the electrical signals received from filaments 34 allows catheter 10 to be used for bipolar (differential or between filament) type mapping as well as unipolar (one filament with respect to a reference) type mapping. [0060] Catheter 10 may also have, as illustrated in FIGS. 2 and 3 , a reference electrode 13 mounted on shaft 12 so that reference electrode 13 is located outside the heart during unipolar mapping operations. [0061] Radiopaque markers can also be provided for use in electrode orientation and identification. [0062] One skilled in the art will appreciate all of the insulation can be removed from filaments 34 to create a large ablation electrode. [0063] Although a complete catheter steerable structure has been illustrated, the invention can also be adapted so that inner tubular member 22 is a catheter shaft, guide wire, or a hollow tubular structure for introduction of saline, contrast media, heparin or other medicines, or introduction of guidewires, or the like. Temperature Sensing [0064] A temperature sensor or sensors, such as, but not limited to, one or more thermocouples may be attached to braided conductive member 28 for temperature sensing during ablation procedures. A plurality of thermocouples may also be woven into the braided conductive member 28 . An individual temperature sensor could be provided for each of the filaments 34 that comprise braided conductive member 28 . Alternatively, braided conductive member 28 can be constructed of one or more temperature sensors themselves. [0065] FIG. 8 illustrates braided conductive member 28 in its fully expanded or deployed configuration. Braided conductive member 28 forms a disk when fully expanded. In the embodiment illustrated in FIG. 8 , there are sixteen filaments 34 that make up braided conductive member 28 . [0066] Temperature monitoring or control can be incorporated into braided conductive member 28 , for example, by placing temperature sensors (such as thermocouples, thermistors, etc.) on the expanded braided conductive member 28 such that they are located on the distally facing ablative ring formed when braided conductive member 28 is in its fully expanded configuration. “Temperature monitoring” refers to temperature reporting and display for physician interaction. “Temperature control” refers to the capability of adding an algorithm in a feedback loop to titrate power based on temperature readings from the temperature sensors disposed on braided conductive member 28 . Temperature sensors can provide a means of temperature control provided the segment of the ablative ring associated with each sensor is independently controllable (e.g., electrically isolated from other regions of the mesh). For example, control can be achieved by dividing the ablative structure into electrically independent sectors, each with a temperature sensor, or alternatively, each with a mechanism to measure impedance in order to facilitate power titration. The ablative structure may be divided into electrically independent sectors so as to provide zone control. The provision of such sectors can be used to provide power control to various sections of braided conductive member 28 . [0067] As illustrated in FIG. 8 , four temperature sensors 70 are provided on braided conductive member 28 . As noted previously, since the individual filaments 34 in braided conductive member 28 are insulated from each other, a number of independent sectors may be provided. A sector may include one or more filaments 34 . During ablation procedures, energy can be applied to one or more of the filaments 34 in any combination desired depending upon the goals of the ablation procedure. A temperature sensor could be provided on each filament 34 of braided conductive member 28 or shared among one or more filaments. In mapping applications, one or more of the filaments 34 can be grouped together for purposes of measuring electrical activity. These sectoring functions can be provided in controller 8 . [0068] FIG. 10 illustrates a side view of braided conductive member 28 including temperature sensors 70 . As shown in FIG. 10 , temperature sensors 70 emerge from four holes 72 . Each hole 72 is disposed in one quadrant of anchor 74 . The temperature sensors 70 are bonded to the outside edge 76 of braided conductive member 28 . Temperature sensors 70 may be isolated by a small piece of polyimide tubing 73 around them and then bonded in place to the filaments. The temperature sensors 7 may be woven and twisted into braided conductive member 28 or they can be bonded on a side-by-side or parallel manner with the filaments 34 . [0069] There are several methods of implementing electrically independent sectors. In one embodiment, the wires are preferably stripped of their insulative coating in the region forming the ablative ring (when expanded). However, sufficient insulation may be left on the wires in order to prevent interconnection when in the expanded state. Alternatively, adjacent mesh wires can be permitted to touch in their stripped region, but can be separated into groups by fully insulated (unstripped) wires imposed, for example, every 3 or 5 wires apart (the number of wires does not limit this invention), thus forming sectors of independently controllable zones. Each zone can have its own temperature sensor. The wires can be “bundled” (or independently attached) to independent outputs of an ablation energy generator. RF energy can then be titrated in its application to each zone by switching power on and off (and applying power to other zones during the ‘off period’) or by modulating voltage or current to the zone (in the case of independent controllers). In either case, the temperature inputs from the temperature sensors can be used in a standard feedback algorithm to control the power delivery. [0070] Alternatively, as illustrated in FIG. 10A , braided conductive member 28 may be used to support a ribbon-like structure which is separated into discrete sectors. As shown in FIG. 10A , the ribbon-like structure 81 may be, for example, a pleated copper flat wire that, as braided conductive member 28 expands, unfolds into an annular ring. Each of the wires 83 a - 83 d lie in the same plane. Although four wires are illustrated in FIG. 10A , structure 81 may include any number of wires depending upon the application and desired performance. Each of wires 83 a - 83 d is insulated. Insulation may then be removed from each wire to create different sectors 85 a - 85 d. Alternatively, each of wires 83 a - 83 d may be uninsulated and insulation may be added to create different sectors. The different sectors provide an ablative zone comprised of independently controllable wires 83 a - 83 d. Temperature sensors 70 may be mounted on the individual wires, and filaments 34 may be connected to respective wires 83 a - 83 d to provide independent control of energy to each individual sector. One skilled in the art will appreciate that each of wires 83 a - 83 d can have multiple sectors formed by removing insulation in various locations and that numerous combinations of sectors 85 a - 85 d and wires 83 a - 83 d forming ribbon-like structure 81 can be obtained. Steering [0071] Reference is now made to FIGS. 11-13 which illustrate aspects of the steering capabilities of the present invention. As illustrated in FIGS. 1-2 , catheter 10 is capable of being steered using control handle 14 . In particular, FIG. 1 illustrates steering where the steering pivot or knuckle is disposed on catheter shaft 12 in a region that is distal to the braided conductive member 28 . [0072] FIG. 11 illustrates catheter 10 wherein the pivot point or steering knuckle is disposed proximal to braided conductive member 28 . [0073] FIG. 12 illustrates catheter 10 having the capability of providing steering knuckles both proximal and distal to braided conductive member 28 . [0074] FIGS. 1-2 , and 11 - 12 illustrate two dimensional or single plane type steering. The catheter of the present invention can also be used in connection with a three dimensional steering mechanism. For example, using the control handle in the incorporated by reference '852 patent, the catheter can be manipulated into a three-dimensional “lasso-like” shape, particularly at the distal end of the catheter. As shown in FIG. 13 , the catheter can have a primary curve 80 in one plane and then a second curve 82 in another plane at an angle to the first plane. With this configuration, the catheter can provide increased access to difficult to reach anatomical structures. For example, a target site for a mapping or ablation operation may be internal to a blood vessel. Thus, the increased steering capability can allow easier access into the target blood vessel. In addition, the additional dimension of steering can allow for better placement of braided conductive member 28 during an ablation or mapping procedure. Catheter 10 can be inserted into a site using the steering capabilities provided by primary curve 80 . Thereafter, using the secondary curve 82 , braided conductive member 28 can be tilted into another plane for better orientation or contact with the target site. Conductive Member Configurations and Materials [0075] Reference is now made to FIGS. 14-17 which figures illustrate other configurations of braided conductive member 28 . As has been described above and will be described in more detail, braided conductive member 28 can include from one to 300 or more filaments. The filaments may vary from very fine wires having small diameters or cross-sectional areas to large wires having relatively large diameters or cross-sectional areas. [0076] FIG. 14 illustrates the use of more than one braided conductive member 28 as the distal end of catheter 10 . As shown in FIG. 14 , three braided conductive members 28 A, 28 B, and 28 C are provided at the distal end of catheter 10 . Braided conductive members 28 A, 28 B, and 29 C may be, in their expanded conditions, the same size or different sizes. Each of the braided conductive members 28 A, 28 B, and 28 C can be expanded or contracted independently in the manner illustrated in FIGS. 1-4 via independent control shafts 26 A, 26 B, and 26 C. The use of multiple braided conductive members provides several advantages. Rather than having to estimate or guess as to the size of the blood vessel prior to starting a mapping or ablation procedure, if braided conductive members 28 A, 28 B, and 28 C are of different expanded diameters, than sizing can be done in vivo during a procedure. In addition, one of the braided conductive members can be used for ablation and another of the braided conductive members can be used for mapping. This allows for quickly checking the effectiveness of an ablation procedure. [0077] Reference is now made to FIGS. 15A and 15B , which figures illustrate other shapes of braided conductive member 28 . As described up to this point, braided conductive member 28 is generally symmetrical and coaxial with respect to catheter shaft 12 . However, certain anatomical structures may have complex three-dimensional shapes that are not easily approximated by a geometrically symmetrical mapping or ablation structure. One example of this type of structure occurs at the CS ostium. To successfully contact these types of anatomical structures, braided conductive member 28 can be “preformed” to a close approximation of that anatomy, and yet still be flexible enough to adapt to variations found in specific patients. Alternatively, braided conductive member 28 can be “preformed” to a close approximation of that anatomy, and be of sufficient strength (as by choice of materials, configuration, etc.) to force the tissue to conform to variations found in specific patients. For example FIG. 15A illustrates braided conductive member 28 disposed about shaft 12 in an off-center or non concentric manner. In addition, braided conductive member 28 may also be constructed so that the parameter of the braided conductive member in its expanded configuration has a non-circular edge so as to improve tissue contact around the parameter of the braided conductive member. FIG. 15B illustrates an example of this type of configuration where the braided conductive member 28 is both off center or non concentric with respect to catheter shaft 12 and also, in its deployed or expanded configuration, has an asymmetric shape. The eccentricity of braided conductive member 28 with respect to the shaft and the asymmetric deployed configurations can be produced by providing additional structural supports in braided conductive member 28 , for example, such as by adding nitinol, ribbon wire, and so on. In addition, varying the winding pitch or individual filament size or placement or deforming selective filaments in braided conductive member 28 or any other means known to those skilled in the art may be used. [0078] FIGS. 16A-16C illustrate another configuration of braided conductive member 28 and catheter 10 . As illustrated in FIGS. 16A-16C , the distal tip section of catheter 10 has been removed and braided conductive member 28 is disposed at the distal end of catheter 10 . One end of braided conductive member 28 is anchored to catheter shaft 12 using an anchor band 90 that clamps the end 32 of braided conductive member 28 to catheter shaft 12 . The other end of braided conductive member 28 is clamped to an activating shaft such as shaft 22 using another anchor band 92 . FIG. 16A illustrates braided conductive member 28 in its undeployed configuration. As shaft 22 is moved distally, braided conductive member 28 emerges or everts from shaft 12 . As shown in FIG. 16B , braided conductive member 28 has reached its fully deployed diameter and an annular tissue contact zone 29 can be placed against an ostium or other anatomical structure. As illustrated in FIG. 16C , further distal movement of shaft 22 can be used to create a concentric locating region 94 that can help to provide for concentric placement within an ostium of a pulmonary vein, for example. Concentric locating region 94 may be formed by selective variations in the winding density of filaments 34 in braided conductive member 28 , preferential predeformation of the filaments, additional eversion of braided conductive member 28 from shaft 12 , or by other means known to those skilled in the art. [0079] Reference is now made to FIG. 17 , which figure illustrates a further embodiment of braided conductive member 28 . As illustrated in FIG. 17 , braided conductive member 28 is composed of one or several large wires 96 rather than a multiplicity of smaller diameter wires. The wire or wires can be moved between the expanded and unexpanded positions in the same manner as illustrated in FIG. 1 . In addition, a region 98 may be provided in which the insulation has been removed for mapping or ablation procedures. The single wire or “corkscrew” configuration provides several advantages. First, the wire or wires do not cross each other and therefore there is only a single winding direction required for manufacture. In addition, the risk of thrombogenicity may be reduced because there is a smaller area of the blood vessel being blocked. In addition, the connections between the ends of the large wire and the control shafts may be simplified. [0080] The catheter 10 of the present invention can be coated with a number of coatings that can enhance the operating properties of braided conductive member 28 . The coatings can be applied by any of a number of techniques and the coatings may include a wide range of polymers and other materials. [0081] Braided conductive member 28 can be coated to reduce its coefficient of friction, thus reducing the possibility of thrombi adhesion to the braided conductive member as well as the possibility of vascular or atrial damage. These coatings can be combined with the insulation on the filaments that make up braided conductive member 28 , these coatings can be included in the insulation itself, or the coatings can be applied on top of the insulation. Examples of coating materials that can be used to improve the lubricity of the catheter include PD slick available from Phelps Dodge Corporation, Ag, Tin, BN. These materials can be applied by an ion beam assisted deposition (“IBAD”) technique developed by, for example, Amp Corporation. [0082] Braided conductive member 28 can also be coated to increase or decrease its thermal conduction which can improve the safety or efficacy of the braided conductive member 28 . This may be achieved by incorporating thermally conductive elements into the electrical insulation of the filaments that make up braided conductive member 28 or as an added coating to the assembly. Alternatively, thermally insulating elements may be incorporated into the electrical insulation of the filaments that make up braided conductive member 28 or added as a coating to the assembly. Polymer mixing, IBAD, or similar technology could be used to add Ag, Pt, Pd, Au, Ir, Cobalt, and others into the insulation or to coat braided conductive member 28 . [0083] Radioopaque coatings or markers can also be used to provide a reference point for orientation of braided conductive member 28 when viewed during fluoroscopic imaging. The materials that provide radiopacity including, for example, Au, Pt, Ir, and other known to those skilled in the art. These materials may be incorporated and used as coatings as described above. [0084] Antithrombogenic coatings, such as heparin and BH, can also be applied to braided conductive member 28 to reduce thrombogenicity to prevent blood aggregation on braided conductive member 28 . These coatings can be applied by dipping or spraying, for example. [0085] As noted above, the filament 34 of braided conductive member 28 may be constructed of metal wire materials. These materials may be, for example, MP35N, nitinol, or stainless steel. Filaments 34 may also be composites of these materials in combination with a core of another material such as silver or platinum. The combination of a highly conductive electrical core material with another material forming the shell of the wire allows the mechanical properties of the shell material to be combined with the electrical conductivity of the core material to achieve better and/or selectable performance. The choice and percentage of core material used in combination with the choice and percentage of shell material used can be selected based on the desired performance characteristics and mechanical/electrical properties desired for a particular application. Irrigation [0086] It is known that for a given electrode side and tissue contact area, the size of a lesion created by radiofrequency (RF) energy is a function of the RF power level and the exposure time. At higher powers, however, the exposure time can be limited by an increase in impedance that occurs when the temperature at the electrode-tissue interface approaches a 100° C. One way of maintaining the temperature less than or equal to this limit is to irrigate the ablation electrode with saline to provide convective cooling so as to control the electrode-tissue interface temperature and thereby prevent an increase in impedance. Accordingly, irrigation of braided conductive member 28 and the tissue site at which a lesion is to be created can be provided in the present invention. FIG. 18 illustrates the use of an irrigation manifold within braided conductive member 28 . An irrigation manifold 100 is disposed along shaft 22 inside braided conductive member 28 . Irrigation manifold 100 may be one or more polyimid tubes. Within braided conductive member 28 , the irrigation manifold splits into a number of smaller tubes 102 that are woven into braided conductive member 28 along a respective filament 34 . A series of holes 104 may be provided in each of the tubes 102 . These holes can be oriented in any number of ways to target a specific site or portion of braided conductive member 28 for irrigation. Irrigation manifold 100 runs through catheter shaft 12 and may be connected to an irrigation delivery device outside the patient used to inject an irrigation fluid, such as saline, for example, such as during an ablation procedure. [0087] The irrigation system can also be used to deliver a contrast fluid for verifying location or changes in vessel diameter. For example, a contrast medium may be perfused prior to ablation and then after an ablation procedure to verify that there have been no changes in the blood vessel diameter. The contrast medium can also be used during mapping procedures to verify placement of braided conductive member 28 . In either ablation or mapping procedures, antithrombogenic fluids, such as heparin can also be perfused to reduce thrombogenicity. [0088] FIG. 19 illustrates another way of providing perfusion/irrigation in catheter 10 . As illustrated in FIG. 19 , the filaments 34 that comprise braided conductive member 28 are composed of a composite wire 110 . The composite wire 110 includes an electrically conductive wire 112 that is used for delivering ablation energy in an ablation procedure or for detecting electrical activity during a mapping procedure. Electrical wire 112 is contained within a lumen 114 that also contains a perfusion lumen 116 . Perfusion lumen 116 is used to deliver irrigation fluid or a contrast fluid as described in connection with FIG. 18 . Once braided conductive member 28 has been constructed with composite wire 110 , the insulation 118 surrounding wire filament 112 can be stripped away to form an electrode surface. Holes can then be provided into perfusion lumen 116 to then allow perfusion at targeted sites along the electrode surface. As with the embodiment illustrated in FIG. 18 , the perfusion lumens can be connected together to form a manifold which manifold can then be connected to, for example, perfusion tube 120 and connected to a fluid delivery device. Shrouds [0089] The use of a shroud or shrouds to cover at least a portion of braided conductive member 28 can be beneficial in several ways. The shroud can add protection to braided conductive member 28 during insertion and removal of catheter 10 . A shroud can also be used to form or shape braided conductive member 28 when in its deployed state. Shrouds may also reduce the risk of thrombi formation on braided conductive member 28 by reducing the area of filament and the number of filament crossings exposed to blood contact. This can be particularly beneficial at the ends 30 and 32 of braided conductive member 28 . The density of filaments at ends 30 and 32 is greatest and the ends can therefore be prone to blood aggregation. The shrouds can be composed of latex balloon material or any material that would be resistant to thrombi formation durable enough to survive insertion through an introducer system, and would not reduce the mobility of braided conductive member 28 . The shrouds can also be composed of an RF transparent material that would allow RF energy to pass through the shroud. If an RF transparent material is used, complete encapsulation of braided conductive member 28 is possible. [0090] A shroud or shrouds may also be useful when irrigation or perfusion is used, since the shrouds can act to direct irrigation or contrast fluid to a target region. [0091] FIGS. 20A-20E illustrate various examples of shrouds that may be used in the present invention. FIG. 20A illustrates shrouds 130 and 132 disposed over end regions 31 and 33 , respectively, of braided conductive member 28 . This configuration can be useful in preventing coagulation of blood at the ends of braided conductive member 28 . FIG. 20B illustrates shrouds 130 and 132 used in conjunction with an internal shroud 134 contained inside braided conductive member 28 . In addition to preventing blood coagulation in regions 31 and 32 , the embodiment illustrated in FIG. 20B also prevents blood from entering braided conductive member 28 . [0092] FIG. 20C illustrates shrouds 130 and 132 being used to direct and irrigation fluid or contrast medium along the circumferential edge of braided conductive member 28 . In the embodiment illustrated in FIG. 20C , perfusion can be provided as illustrated in FIGS. 18 and 19 . [0093] FIG. 20D illustrates the use of an external shroud that covers braided conductive member 28 . Shroud 136 completely encases braided conductive member 28 and thereby eliminates blood contact with braided conductive member 28 . Shroud 136 may be constructed of a flexible yet ablation-energy transparent material so that, when used in an ablation procedure, braided conductive member 28 can still deliver energy to a targeted ablation site. [0094] FIG. 20E also illustrates an external shroud 137 encasing braided conductive member 28 . Shroud 137 may also be constructed of a flexible yet ablation-energy transparent material. Openings 139 may be provided in shroud 137 to allow the portions of braided conductive member 28 that are exposed by the opening to come into contact with tissue. Openings 139 may be elliptical, circular, circumferential, etc. Guiding Sheaths [0095] There may be times during ablation or mapping procedures when catheter 10 is passing through difficult or tortuous vasculature. During these times, it may be helpful to have a guiding sheath through which to pass catheter 10 so as to allow easier passage through the patient's vasculature. [0096] FIG. 21 illustrates one example of a guiding sheath that may be used in connection with catheter 10 . As illustrated in FIG. 21 , the guiding sheath 140 includes a longitudinal member 142 . Longitudinal member 142 may be constructed of a material rigid enough to be pushed next to catheter shaft 12 as the catheter is threaded through the vasiculature. In one example, longitudinal member 142 may be stainless steel. Longitudinal member 142 is attached to a sheath 144 disposed at the distal end 146 of longitudinal member 142 . The split sheath 144 may have one or more predetermined curves 148 that are compatible with the shapes of particular blood vessels (arteries or veins) that catheter 10 needs to pass through. Split sheath 144 may extend proximally along longitudinal member 142 . For example, sheath 144 and longitudinal member 142 may be bonded together for a length of up to 20 or 30 centimeters to allow easier passage through the patient's blood vessels. Sheath 144 includes a predetermined region 150 that extends longitudinally along sheath 144 . Region 150 may be, for example, a seam, that allows sheath 144 to be split open so that the guiding sheath 140 can be pulled back and peeled off catheter shaft 12 in order to remove the sheath. [0097] In another embodiment, longitudinal member 142 may be a hypotube or the like having an opening 152 at distal end 146 that communicates with the interior of sheath 144 . In this embodiment, longitudinal member 142 can be used to inject irrigation fluid such as saline or a contrast medium for purposes of cooling, flushing, or visualization. Methods of Use [0098] Reference is now made to FIGS. 22 , 23 , and 24 , which figures illustrate how the catheter of the present invention may be used in endocardial and epicardial applications. [0099] Referring to FIG. 22 , this figure illustrates an endocardial ablation procedure. In this procedure, catheter shaft 12 is introduced into a patient's heart 150 . Appropriate imaging guidance (direct visual assessment, camera port, fluoroscopy, echocardiographic, magnetic resonance, etc.) can be used. FIG. 22 in particular illustrates catheter shaft 12 being placed in the left atrium of the patient's heart. Once catheter shaft 12 reaches the patient's left atrium, it may then be introduced through an ostium 152 of a pulmonary vein 154 . As illustrated, braided conductive member 28 is then expanded to its deployed position, where, in the illustrated embodiment, braided conductive member 28 forms a disk. Catheter shaft 12 then advanced further into pulmonary vein 154 until the distal side 156 of braided conductive member 28 makes contact with the ostium of pulmonary vein 154 . External pressure may be applied along catheter shaft 12 to achieve the desired level of contact of braided conductive member 28 with the ostium tissue. Energy is then applied to the ostium tissue 152 in contact with braided conductive member 28 to create an annular lesion at or near the ostium. The energy used may be RF (radiofrequency), DC, microwave, ultrasonic, cryothermal, optical, etc. [0100] Reference is now made to FIG. 23 , which figure illustrates an epicardial ablation procedure. As illustrated in FIG. 23 , catheter shaft 12 is introduced into a patient's thoracic cavity and directed to pulmonary vein 154 . Catheter 10 may be introduced through a trocar port or intraoperatively during open chest surgery Using a steering mechanism, preformed shape, or other means by which to make contact between braided conductive member 128 and the outer surface 158 of pulmonary vein 154 , braided conductive member 28 is brought into contact with the outer surface 158 of pulmonary vein 154 . Appropriate imaging guidance (direct visual assessment, camera port, fluoroscopy, echocardiographic, magnetic resonance, etc.) can be used. As illustrated in FIG. 23 , in this procedure, braided conductive member 28 remains in its undeployed or unexpanded condition. External pressure may be applied to achieve contact between braided conductive member 28 with pulmonary vein 154 . Once the desired contact with the outer surface 158 of pulmonary vein 154 is attained, ablation energy is applied to surface 158 via braided conductive member 28 using, for example, RF, DC, ultrasound, microwave, cryothermal, or optical energy. Thereafter, braided conductive member 28 may be moved around the circumference of pulmonary vein 154 , and the ablation procedure repeated. This procedure may be used to create, for example, an annular lesion at or near the ostium. [0101] Use of the illustrated endocardial or epicardial procedures may be easier and faster than using a single “point” electrode since a complete annular lesion may be created in one application of RF energy. [0102] Reference is now made to FIG. 24 which figure illustrates an endocardial mapping procedure. In the procedure illustrated in FIG. 24 , catheter shaft 12 is introduced into pulmonary vein 154 in the manner described in connection with FIG. 22 . Once braided conductive 28 has reached a desired location within pulmonary vein 154 , braided conductive member 28 is expanded as described in connection with, for example, FIGS. 2-5 until filaments 34 contact the inner wall 160 of pulmonary vein 154 . Thereafter, electrical activity within pulmonary vein 154 may be detected, measured, and recorded by an external device connected to the filaments 34 of braided conductive member 28 . [0103] Access to the patient's heart can be accomplished via percutaneous, vascular, surgical (e.g. open-chest surgery), or transthoracic approaches for either endocardial or epicardial mapping and/or mapping and ablation procedures. [0104] The present invention is thus able to provide an electrophysiology catheter capable of mapping and/or mapping and ablation operations. In addition, the catheter of the invention may be used to provide high density maps of a tissue region because electrocardiograms may be obtained from individual filaments 34 in braided conductive member 28 in either a bipolar or unipolar mode. [0105] Furthermore, the shape of the electrode region can be adjusted by controlling the radial expansion of braided conductive member 28 so as to improve conformity with the patient's tissue or to provide a desired mapping or ablation profile. Alternatively, braided conductive member 28 may be fabricated of a material of sufficient flexural strength so that the tissue is preferentially conformed to match the expanded or partially expanded shape of the braided conductive member 28 . [0106] The catheter of the present invention may be used for mapping procedures, ablation procedures, and temperature measurement and control on the distal and/or proximal facing sides of braided conductive member 28 in its fully expanded positions as illustrated in, for example, FIG. 1 . In addition, the catheter of the present invention can be used to perform “radial” mapping procedures, ablation procedures, and temperature measurement and control. That is, the outer circumferential edge 76 , illustrated, for example, in FIG. 8 , can be applied against an inner circumferential surface of a blood vessel. [0107] Furthermore, being able to use the same catheter for both mapping and ablation procedures has the potential to reduce procedure time and reduce X-ray exposure. [0108] The ability to expand braided conductive member 28 in an artery or vein against a tissue structure such as a freewall or ostium can provide good contact pressure for multiple electrodes and can provide an anatomical anchor for stability. Temperature sensors can be positioned definitively against the endocardium to provide good thermal conduction to the tissue. Lesions can be selectively produced at various sections around the circumference of braided conductive member 28 without having to reposition catheter 10 . This can provide more accurate lesion placement within the artery or vein. [0109] Braided conductive member 28 , in its radially expanded position as illustrated in particular in FIGS. 1 and 8 is advantageous because, in these embodiments, it does not block the blood vessel during a mapping or ablation procedure, but allows blood flow through the braided conductive member thus allowing for longer mapping and/or ablation times, which can potentially improve accuracy of mapping and efficacy of lesion creation. [0110] Having thus described at least one illustrative embodiment of the invention, various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description is by way of example only and is not intended as limiting. The invention is limited only as defined in the following claims and the equivalents thereto.

Embodiments described herein relate to methods of using a catheter having a braided conductive member. One embodiment relates to a method for treating a condition of a patient that involves contacting an exterior wall of a blood vessel with the braided conductive member. Another embodiment relates to a method that involves contacting a wall of a blood vessel with the braided conductive member and controlling energy delivery to the braided conductive member based on at least one sensed temperature.

FIELD [0001] This invention relates generally to finger printing technology, and more particularly to finger print image acquisition. BACKGROUND [0002] The main purpose of law enforcement at a crime scene is to document, preserve, and collect evidence. An important part of such evidence is the collection of latent fingerprints. These prints are used to identify individuals who were at the crime scene. For this process to work, there must be a database or library of known fingerprints on file. To compile such a database, the fingerprints (and now palm prints) of every person arrested for a criminal offence are taken during the booking process. The equipment used to capture the prints is predominantly electronic with the use of a “Live Scan” device, having a transparent glass surface for acquiring high-resolution images of fingers and palms pressed against the transparent glass surface. [0003] Live Scan fingerprinting enables capture of fingerprints and palm prints electronically, without the need for the more traditional method of ink and paper. [0004] In the US, most law enforcement agencies use Live Scan technology as their primary tool in the recognition of persons. Live Scan is commonly used for criminal booking, sexual offender registration, civil applicant, and background checks. In the UK, many major police custody suits are now equipped with Live Scan machines, which enable suspects' fingerprints to be instantly compared with a national database. [0005] The old method using ink and paper for obtaining fingerprints used ink to transfer the elevated ridge detail of a person's hand to paper that was later scanned into the Automated Fingerprint Identification System (AFIS) database. The new Live Scan method scans the hand directly into the system without ink. The same Live Scan machines are also used to acquire and record fingerprints of people for jobs or licenses, such as firearms permits, and the problems described below apply to these uses as well. [0006] A Live Scan device captures images of only the part of the hand (such as a finger or a palm) that makes contact with the glass, and produces an image of just the raised ridges, the raised ridges being used to identify the person. However, if there is interference with the skin making full contact with the glass of the live scanner device, a poor image of the identifying ridges will result. [0007] With the present use of Live Scan devices to capture the image, the key issues have become: skin quality of the person being fingerprinted, and substances that may be found on the skin of the person being fingerprinted. There are a few problems that can arise when attempting to acquire an image of a fingerprint or a palm print using a live scanner device: [0008] 1. Images can be Too Light [0009] This can happen due to lack of moisture on the skin, which causes the image to show up very light, and in some cases the image can be so light as to be unreadable. [0010] 2. Images can be Too Dark [0011] Excess sweat, water, oil, or any moisture can cause the image to darken to the point where the ridge lines come together and produce a black spot in the image, or blacking out an entire area of the image. [0012] 3. Missing Areas in the Image— [0013] When skin is peeling, or has a callused area such areas can show up blank, or too light to see. Finger joint areas that are slightly recessed but nevertheless have ridge lines that can provide information are often not imaged at all. [0014] 4. Inconsistent Image Darkness— [0015] If the entire area scanned does not have a consistent moisture level, then the image will have light and dark areas that make the image of the print hard to see and/or hard to understand. [0016] If any one of the issues above are present with enough severity, then the scan will be rejected and the scan must be redone. When dealing with an uncooperative subject, or someone who is under the influence of drugs or alcohol, this becomes not only an inconvenience, but can become an officer safety issue if the subject becomes agitated that the process is taking too long. [0017] Attempted Solutions [0018] 1. Images can be Too Light— [0019] Plain or distilled water can be applied with a fine mist from a spray bottle. When water is used on some live scan devics, it is too difficult to apply without over-applying and causing the entire area to turn black, and so a lot of time is spent waiting for the skin to dry enough to proceed. Lotions or oils by themselves are nearly impossible to apply without using too much, thereby causing the same black out effect. Other products, such as Ridge Builder™ or EZ Scan™ are in liquid form, and are therefore easily spilled and require thorough washing and then drying of the hands prior to and after application. Some of the current products available have a large amount of alcohol (as much as 98.2%), which can be dangerous to keep in a jail or a prison where the product could be consumed easily or splashed into an Officer's eyes due to it being in liquid form. High alcohol content can also pose a serious problem when the breathalyzer is being used during a booking procedure. [0020] 2. Images can be Too Dark— [0021] This issue will remain constant even without the use of an additional product. This issue can be solved by cleaning the hands prior to scanning, thereby drying out the skin, possibly resulting in images that can be too light. [0022] 3. Missing Areas in the Image— [0023] To have the Live Scan device pick up on the missing areas from a callused area of the hand, the same techniques for dealing with light images have been used, and similar problems are experienced. Moreover, joint areas still fail to be imaged. [0024] 4. Inconsistent Image Darkness— [0025] The problem posed by products that are currently available is that it is difficult to apply such products evenly so as to produce consistent image darkness. When a liquid product is applied, the goal is to apply the product evenly. It if is not applied evenly, the image will be dark in some spots while light in others. When water is used, three outcomes are possible. One is that if the person has any lotion, contaminants, dirt, or oil on their hand, the water mixes with them to produce a mud-like substance, resulting in a mess on the glass, thereby producing unusable images. Also, the water is absorbed into some areas of the skin faster than others, and in some areas the water remains on the surface and causes blotchy images. Further, the water must be applied several times on each hand because it evaporates quickly, which wastes time and becomes frustrating to the person being printed. [0026] The problems introduced by the use of water, or products presently available, is that while in some cases they may work, they work only inconsistently throughout a fingerprinting session, and depend on the person to be fingerprinted being willing to cooperate throughout the session, which cannot be relied upon. [0027] Latent fingerprints from crime scenes that are collected by law enforcement officers worldwide are not always perfect, and are not always complete prints. Sometimes, all the print examiner has to work with is a small portion of a suspect's fingerprint. Consequently, if the library of fingerprints on file is of poor quality, or has missing areas due simply to a bad scan, then there is a greater chance that no match will be found, and a crime could go unsolved. SUMMARY [0028] The preparation of the invention enables Automated Fingerprint Identification Systems (AFIS) and Integrated Automated Fingerprint Identification Systems (IAFIS) Live Scan machines to capture more detailed and complete fingerprint and palm print images, usually on the first attempt. The preparation of the invention provides clear, crisp, dark, and detailed images of fingers and palms pressed against the glass of a Live Scan machine. The preparation of the invention can reveal more accurate minutiae and discernable patterns, and this additional data is easily incorporated into the AFIS database. The preparation of the invention is a waxy solid that is most advantageously dispensed in stick form, that can be easily applied evenly to fingers and palm, and that can remain on the skin for an entire session of fingerprinting and palm printing using a Live Scan machine. It is good for the skin, and does not need to be washed off or removed after use. Use of the preparation reduces the amount of rejected prints, and increases the number of high quality prints. [0029] Databases of fingerprints are only as good as the images scanned into the system. If a scanned image of a fingerprint bears too many defects and gaps (missing minutia), the scanned image is useless in that it cannot be used to identify an individual. [0030] When dealing with applications or licensing issues, the ability to capture a better image of a person's fingerprint can lessen the chance of a rejected application, and saves time and money. More importantly, this is not a problem where the solution can just save a few dollars to the user, or save time on doing a task—improved print image quality due to the use of the preparation of the invention could save lives. With higher quality fingerprint images in the database, a person who commits a crime will have a better chance of being apprehended before they can offend again. [0031] Finger joint areas that are slightly recessed but nevertheless have ridge lines can now be imaged, thereby providing further information for use in identification. In particular, the area below the first crease of the fingertip is almost never present on a scan without some sort of product applied. While other products can be used to enhance images of this portion of the finger, the same problems arise, such as alcohol content, toxic materials, evaporation, uneven application, over application, etc. The preparation of the invention avoids all of these problems. Good imaging of this portion of the finger is very important when matching latent fingerprints from crime scenes that may only include information from this portion of the finger, so without the use of an image enhancement formulation, there would be no data to compare with the original scan. [0032] Use of the preparation of the invention on dry skin results in darker print images that would typically be too light. [0033] Use of the preparation of the invention prior to scanning provides an even contrast over an entire scan image. [0034] Use of the preparation of the invention prior to scanning allows users to attain passing scans more often with fewer rejected scans. [0035] Use of the preparation of the invention prior to scanning enables users to obtain highly optimized images of fingerprints and palm prints. [0036] Use of the preparation of the invention prior to scanning results in scan images having crisp images of print ridge detail. [0037] Use of the preparation of the invention avoids over-application by being presented to the fingers and palm in solid form, unlike all other known preparations for enhancement of Live Scan images. [0038] A general aspect of the invention is a preparation for enhancement of imaging of finger prints and palm prints on a transparent surface of a live scan device. The preparation includes a mixture of: beeswax; squalane; jojoba oil; and tea tree oil. [0039] In some embodiments, the preparation consists of a mixture of: 20%-70% beeswax; 1.0%-50% squalane; 1.0%-10% jojoba oil; and 0.1%-5.0% tea tree oil. [0040] In some embodiments, the preparation consists of a mixture of: 60% beeswax; 30% squalane; 9% jojoba oil; and 1% tea tree oil. [0041] In some embodiments, the mixture is solid at room temperature, and is molded into a shape that facilitates application to at least one of a finger and a palm of a person. [0042] In some embodiments, the beeswax is replaced by at least one of: Carnuba Wax, Candelilla Wax, Pola Wax, Rice Bran Wax, Soy Wax, emulsifying wax NF (e-wax). [0043] In some embodiments, the squalane is replaced by one of: glycerin, sorbitol, sodium hyaluronate, urea, alpha hydroxy acids. [0044] In some embodiments, the squalane is replaced by a mixture of: Hydrogenated Poly (C6-14 Olefin); Olea Europa (Olive) Fruit Extract; Beta-Sitosterol; and Mixed Tocopherols. [0045] In some embodiments, the jojoba oil is replaced by at least one of: olive oil, canola oil, grapeseed oil, safflower oil, argan oil, coconut oil, babassu oil, camellio oil, sunflower oil, flaxseed oil, vegetable oil, avocado oil. [0046] In some embodiments, the jojoba oil is replaced by a mixture of: Limnanthes Alba (Meadowfoam) Seed Oil; Hydrogenated Poly (C6-14 Olefin); Olea Europa (Olive) Fruit Extract; Beta-Sitosterol; and Mixed Tocopherols. [0047] In some embodiments, the tea tree oil is replaced by one of: thymol crystals, Zinc, Urea. [0048] Another general aspect of the invention is a preparation for enhancement of imaging of finger prints and palm prints on a transparent surface of a live scan device, where the preparation consists of a mixture of: 60% beeswax; 30% squalane; 9% jojoba oil; and 1% tea tree oil. [0049] In some embodiments, the mixture is solid at room temperature, and is molded into a shape that facilitates application to at least one of a finger and a palm of a person. [0050] In some embodiments, the beeswax is replaced by one of: Candelilla Wax, Rice Bran Wax, Soy Wax. [0051] In some embodiments, the squalane is replaced by a mixture of: Hydrogenated Poly (C6-14 Olefin); Olea Europa (Olive) Fruit Extract; Beta-Sitosterol; and Mixed Tocopherols. [0052] In some embodiments, the jojoba oil is replaced by a mixture of: Limnanthes Alba (Meadowfoam) Seed Oil; Hydrogenated Poly (C6-14 Olefin); Olea Europa (Olive) Fruit Extract; Beta-Sitosterol; and Mixed Tocopherols. [0053] In some embodiments, the tea tree oil is replaced by one of: thymol crystals, Zinc, Urea. [0054] Another general aspect of the invention is a preparation for enhancement of imaging of finger prints and palm prints on a transparent surface of a live scan device, the preparation being a solid mixture of: a moisturizer to swell the ridges of the skin; an oil augmenter to add to the oil on the ridges of the skin, which are to be pressed against the glass of the Live Scan machine to create dark image lines; and a waxy matrix to be admixed with the moisturizer and the oil augmenter so as to keep the entire mixture solid at room temperatures, while facilitating transfer at least the moisturizer and the oil augmenter to the skin of fingers and palms to be printed when the solid mixture is applied thereto. [0055] In some embodiments, the preparation further includes an antimicrobial agent to prevent the moisturizer and the oil augmenter from spreading and promoting the growth of microbes. [0056] In some embodiments, the oil augmenter is jojoba oil. [0057] In some embodiments, the moisturizer is squalane. DETAILED DESCRIPTION [0058] The preparation of the invention has been formulated to have the following attributes: [0059] Moisturizes the skin so as to allow for higher print image quality on an AFIS Live Scan machine. [0060] Includes antimicrobial ingredients to maximize sanitary conditions. [0061] Has a high melting point so it will remain solid so that it can work effectively even in hot climates. [0062] Includes no alcohol so that it is safe to use around a breathalyzer without distorting test results. [0063] Contains no harmful or toxic ingredients, and so it is safe for use in secure locations, such as jails, prisons, booking areas, or mental institutions. [0064] Will not stain clothing. [0065] Has all plastic packaging that is safe for use in jails or police stations. [0066] Can be packaged and used in “stick” form, like a deodorant stick or a lip balm. [0067] Will not spill, splash, leak, or dry out. [0068] Can dispense more uses per stick than can be dispensed by containers of competing preparations. [0069] The above attributes are achieved by an elegant formulation that serves to: [0070] 1. Swell ridges on the surface of the fingers and palm using a moisturizing agent. Even worn ridges swell enough so as to allow better detail to be captured by a Live Scan machine. [0071] 2. Replace or augment the natural oils typically found on the skin of fingers and palms, resulting in images of sufficient darkness even in dry or callused areas, without leaving excess residue. This is accomplished by using an oil found in nature that is very similar to sebum, the oily substance normally found on skin. [0072] 3. Inhibit the growth and spread of germs by including an antimicrobial agent, without the use of alcohol that can distort the results of a breathalyzer test. [0073] 4. Dispense as a waxy solid in the form of a convenient easily controllable applicator stick, resembling a solid deodorant stick or solid lip balm dispenser. [0074] To meet these objectives, a preferred formulation includes a mixture of: [0075] Squalane to moisturize and thereby swell the ridges of the skin; [0076] Jojoba Oil to augment the oil on the ridges of the skin, which are to be pressed against the glass of the Live Scan machine to create dark image lines; [0077] Tea Tree Oil to serve as an antimicrobial agent to prevent the moisturizer and oil augmenter from supporting or promoting the growth of microbes; and [0078] Beeswax to be admixed with the moisturizer, the oil augmenter, and the antimicrobial so as to keep the entire mixture solid at room temperatures, while transferring at least the moisturizer and the oil augmenter to the skin of fingers and palms to be printed when the solid mixture is applied thereto. [0079] Ideally, the formulation will be a mixture consisting of: [0000] Beeswax 60% Squalane 30% Jojoba Golden Oil 9% (The “Golden Oil” is the Jojoba oil that is first produced from the extraction from seed before it is refined. 100% cold pressed jojoba -- virgin jojoba oil -- is a clear golden color.) Tea Tree Oil 1% [0080] This mixture is a solid with a melting point of about 122 degrees F. Thus, the finished product will not melt at room temperature (25 degrees C.), and that is why it can be formed as a stick. Beeswax has a melting temperature of around 62 degrees C. The other three ingredients are liquid oils at room temperature (25*C). [0081] The effective range (Min-Max) of each ingredient percentage that would still result in an effective formulation is: [0000] Beeswax 20%-70% Squalane 1.0%-50%  Jojoba Golden Oil 1.0%-10%  Tea Tree Oil 0.1%-5.0% [0082] Beeswax has a high binding strength and exhibits excellent ability to emulsify, improve structure, provide oil retention, and facilitate mold release for stick applications. Suitable substitutes for Beeswax include: Carnuba Wax, Candelilla Wax, Pola Wax, Rice Bran Wax, Soy Wax, emulsifying wax NF (e-wax), or any other wax or mixture of waxes that has a similar melting point that can hold the other ingredients in suspension, maintain solid form during storage and use, and allow a controlled and even application of the mixture to be applied to the skin. Beeswax was chosen also because it is non-toxic and inexpensive, and can hold the other ingredients in a suspension while allowing a precise and small measured amount of the other ingredients to be applied to the skin, consistently with each application. [0083] Processed beeswax was chosen due to it being inexpensive, easy to procure, as well as providing consistent samples that do not vary due to other outside factors. For example, organic beeswax can have inconsistencies due to being unrefined. [0084] If the beeswax or substitute was not included in the formulation of the invention, the other ingredients of the formulation would be in liquid form, and consequently it would be difficult to control the application of the formulation to the skin precisely, and it would be difficult to limit the amount of the formulation applied to the skin, and it would be difficult to prevent leaks and spills, and thus the formulation without beeswax or an equivalent would not work as well as the solid form. [0085] Squalane is an excellent moisturizer, helping to swell the ridges of the skin with moisture, soften the skin, and restore natural protective barrier properties against environmental stresses. It stimulates healing and soothes the skin. One substitute for Squalane is a mixture of: Hydrogenated Poly (C6-14 Olefin); AND Olea Europa (Olive) Fruit Extract; AND Beta-Sitosterol; AND Mixed Tocopherols. Other substitute moisturizing agents that are able to remain in suspension with the other ingredients, and provide moisture in a measured and even amount to the skin can also be used. Squalane was chosen because it is an excellent moisturizer and emollient. It is important to provide moisture to the fingers and palm to be printed so as to plump and swell key features of a person's skin surface in a controlled manner. This results in more contact of the ridges with the glass of the Live Scan machine, and less contact of the non-raised portion of the skin, resulting in more detail acquired by the Live Scan device. This particularly enhances the image of skin that is worn or elderly, and therefore relatively smooth prior to application of an embodiment of the formulation of the invention. [0086] Suitable substitute for squalane can be any other moisturizing agent, especially any ingredient that contains a humectant, such as glycerin, sorbitol, sodium hyaluronate, urea, and/or alpha hydroxy acids. Some squalane is derived from fish. A favorable form of squalane is derived from the olive plant, or other suitable plant. [0087] However squalane was chosen because it is found naturally in the skin, the ease and speed of absorption into the skin, as well as the absence of alcohol, which other known formulations actually include, even though the presence of alcohol in known formulations can interfere with breathalyzer testing. [0088] If squalane (or other suitable moisturizer) was not included in the formulation of the invention, the amount of oil used (whatever that oil may be), would have to be increased to the point where it would be too soft and too greasy to use. Alternatively, if the oil percentage was not increased, the lack of squalane would leave the beeswax (or it's substitute) way too hard and difficult to apply. Consequently, such a formulation without squalane or equivalent moisturizer would not work well enough to swell the ridges of the skin on the finger, and so would fail to enhance imaging of the fingerprint and/or palm print. [0089] Jojoba Oil has very good effects on the skin, acting as a moisturizer and emollient agent to improve skin elasticity and suppleness. Also, Jojoba oil is chemically very similar to sebum as naturally found in skin. Thus, it augments the oiliness of skin in a very natural way. Jojoba contains natural tocopherols to minimize oxidation, and thereby reduces rancidity caused by lipid peroxidation. Jojoba oil can be replaced by a mixture of: Limnanthes Alba (Meadowfoam) Seed Oil; Hydrogenated Poly (C6-14 Olefin); Olea Europa (Olive) Fruit Extract; Beta-Sitosterol; and Mixed Tocopherols, or any other oil or oily mixture that is able to remain in suspension with the other ingredients and provide oil augmentation in a measured and even amount to the skin. Jojoba oil was chosen because of close chemical similarity with the oils found in sebum that is secreted when a person sweats. Thus, Jojoba oil adds to or replaces oils normally secreted by the body, and thereby darkens images acquired by a Live Scan machine. [0090] Suitable substitutes for jojoba oil can be any other oil able to be held in suspension with the other ingredients that can be applied evenly in controlled amounts to the skin, thereby allowing a darker image to result. Suitable substitute oils include one or a mixture of: olive oil, canola oil, grapeseed oil, safflower oil, argan oil, coconut oil, babassu oil, camellio oil, sunflower oil, flaxseed oil, vegetable oil, avocado oil. [0091] However, jojoba oil was chosen as the preferred oil because it is relatively lightweight and thin, as well as almost exactly replicating the properties of oils found in sebum, a substance commonly found in and on the skin. [0092] If Jojoba oil or an equivalent was not included in the formulation, the formulation would be effective, but not as effective as the complete formulation, since the oil in the skin as augmented by the jojoba oil is what darkens the image, thereby providing more print information. However, there may be enough oil in the other ingredients of the formulation of the invention, such as Tea tree oil or squalane, or equivalents, that the formulation without jojoba oil or an equivalent could still provide modest performance. [0093] Tea Tree Oil is a proven anti-bacterial, anti-fungal, anti-viral, and anti-inflammatory. Applications include acne, wounds, Methicillin-resistant Staphylococcus aureus (MRSA), dandruff, and hand/body washes. Tea tree oil was chosen because it is non-toxic, and promotes a sanitary condition on the stick of the mixture without harsh chemicals or alcohol. Although thymol crystals could also be used, thymol crystals are more expensive and not readily available. [0094] Tea tree oil substitutes can be any antimicrobial agent able to be added and held in suspension that can discourage the growth of bacteria and other germs. Suitable substitutes include: thymol crystals, Zinc, and/or Urea. [0095] However, Tea tree oil was chosen due to its easy availability and lower cost. [0096] If an antimicrobial agent was not included in the formulation, the formulation would still work, but there would be more of a risk of the spread of disease due to bacteria or other disease organisms due to contact of the stick with the skin of many persons. [0097] To use the preparation of the invention in solid stick form, first remove the cap from the dispenser (such as found in many solid deodorants, or solid lip balms) to expose an end of the solid stick of the preparation. Apply the end of the solid stick to the surface to be printed of each finger, and optionally to the palm to be printed. For example, one can run the stick up one side of a finger, and down the other side, repeating for each finger. The preparation can be applied to the palm using a zig-zag pattern, for example. Next, using a glove that is resistant to degradation by oil, rub all surfaces with a gloved thumb so as to ensure that the preparation is evenly spread over all surfaces to be printed using the Live Scan machine. [0098] Although the best form to present the preparation of the invention to the fingers is a solid stick of the formulation, the formulation can also be contained in a shallow container with an opening large enough to enable application to each finger by wiping the pad of each finger on the surface of the preparation in the shallow container. The container is shallow so that the walls of the container do not interfere with the wiping action of a finger over the solid surface of the preparation. Alternatively, the container can be sized so that it can accommodate an entire hand to be printed, including all fingers and the palm. [0099] Other modifications and implementations will occur to those skilled in the art without departing from the spirit and the scope of the invention as claimed. Accordingly, the above description is not intended to limit the invention, except as indicated in the following claims.

A preparation is provided for enhancement of imaging of fingerprints and palm prints acquired using a Live Scan device. The preparation is solid at room temperature, even in hot climates, and can be consistently applied. The preparation is a mixture of: 20%-70% beeswax; 1.0%-50% squalane; 1.0%-10% jojoba oil; and 0.1%-5.0% tea tree oil. The mixture can be advantageously molded into a shape that facilitates application, such as the shape of a deodorant stick or lip balm. Preferably, the preparation consists of: 60% beeswax; 30% squalane; 9% jojoba oil; and 1% tea tree oil. The preparation moisturizes skin to facilitate higher quality images on AFIS or IAFIS Live Scanners, and includes an antimicrobial to maximize sanitary conditions, includes no alcohol to be safe to use around a breathalyzer, is non-toxic for use in jails and mental institutions, and will not stain clothing.

CROSS-REFERENCE TO RELATED APPLICATION This application is filed as a divisional of patent application No. 08/857,476 filed May 15, 1997, now abandoned. BACKGROUND OF THE INVENTION This invention relates to a training aid. When doing the exercise known as the bench press, a lifter lies on a horizontal bench with his buttocks, shoulders and head in contact with the bench. The knees are bent so that the feet can be placed flat on the floor, which assists in stabilizing the lifter on the bench. The lifter reaches up and grasps a barbell in both hands. The lifter takes a deep breath, stabilizing the chest to give a firm base for the muscular action involved in the lift. In his own time, the user lowers the barbell to his chest. This must be done under control. The lifter drives the bar from the chest, in the initial starting position, when the barbell is resting on the chest, it will not lie over the fulcrum of the shoulder joint but will be some 2 or 3 inches forward of this point. This means that there is a forward weight arm and consequent mechanical disadvantage right from the start of the drive. The forward weight arm must be eliminated and in order to do this the user eases the barbell back during the drive to bring it over the shoulder fulcrum. While the drive must be very determined, care must be taken to ensure that the elbows are not lifted upwards and forward, as this would throw too great a resistance on the triceps too soon. It will be in the mid-range of the movement that the user will encounter the greatest difficulties. This area is known as the "sticking point" or point of the greatest mechanical and anatomical disadvantage. Here the horizontal weight arms are at their greatest and there is a weak link between the change over of one muscle group to another. The initial part of the drive is developed by strong action of the pectoralis major, anterior deltoid and serratus anterior. At the mid-section of the press, the role of these muscles is diminishing and the triceps are beginning to take on a greater responsibility in the movement. It is here that the weakness occurs. As the barbell passes through the mid-range, it becomes increasingly easy to complete the movement. The lift is completed when the arms are fully straightened. It is important to note that the groove is a spot that is 1 to 3 inches up from the bottom of the lower pectoralis major. Maintaining the groove position is very important, in order to obtain the best mechanical advantage. The aim in the bench press exercise is to complete a certain number of repetitions, e.g. 10 repetitions, with a given weight on the barbell. The lifter may train at a first weight level until he is comfortable at that weight level and can perform the desired number of repetitions, and then increase the weight of the barbell to a higher level and train at the higher level until he is comfortable at that weight level and can perform the desired number of repetitions. In this manner, the lifter progressively increases the weight level at which he exercises. There are mental and physical barriers to increasing the weight level in the bench press exercise. First, the effort that the lifter can exert when pushing the barbell upward is lower when the barbell is just touching the lifter's chest than when the barbell is slightly above the lifter's chest and consequently, when the weight of the barbell is increased, the fear of being unable to raise the barbell may intimidate the lifter as he lowers the barbell and he might not lower the barbell fully, so that it touches his chest. Secondly, assuming that the lifter is able to lower the barbell at the higher weight level so that the bar just touches his chest, there is a danger of injury, particularly to the shoulder, on exerting the effort needed to raise the barbell at the higher weight level. SUMMARY OF THE INVENTION In accordance with the present invention there is provided a training aid, for assisting a lifter in training for the bench press exercise, in which the lifter lifts a bar from a lower position to a higher position relative to the lifter's shoulders, said training aid comprising a harness to be worn by the lifter, and at least one spacer attached to the harness at a position in which the spacer is below the bar when the harness is in use and the bar is in its lower position, the spacer limiting the extent to which the bar can be moved from its higher position toward its lower position before contacting the exercise aid. BRIEF DESCRIPTION OF THE DRAWINGS For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which FIG. 1 is a front elevation, partly broken away, of a first training aid in accordance with the present invention, FIG. 2 is a top plan view showing the training aid in use, FIG. 3 is a view on the line III--III of FIG. 2, FIG. 4 is a view similar to FIG. 1 of a second training aid in accordance with the present invention, and FIG. 5 is a perspective view of a component of the training aid shown in FIG. 4. DETAILED DESCRIPTION The first training aid, which is shown in FIGS. 1-3, is in the form of a harness which is worn by a weight lifter to aid in progressing to a higher weight level when performing the bench press exercise. The harness comprises a generally trapezoidal component 10 of a tough sheet-form fabric material having corner regions 12A, 12B, 12C and 12D. At each corner region 12, an anchor 14 is securely attached to the component 10. The two upper anchors 14A and 14B include rectangular link elements 16 each attached to one end of an upper strap 18. The opposite end of the upper strap 18 is attached to an outer bar of a slide buckle 20, and the strap is threaded through the buckle 20 to form a loop. The loop formed by the slide buckle 20 passes through a central ring 24. By adjusting the slide buckle 20 along the strap 18, the effective length of the upper strap between the anchor 14A or 14B and the ring 24 is adjustable. The two lower anchors 14C and 14D each include one part 26 of a quick-release clip 28, the other part 30 of which is attached to one end of a lower strap 32. The opposite end of the lower strap 32 is attached to an outer bar of a slide buckle 34 to form a loop. The loop formed by the slide buckle 34 passes through the central ring 24 and by adjusting the slide buckle 34 the effective length of the lower strap between the anchor 14C or 14D and the ring 24 is adjustable. On the front of the trapezoidal fabric component 10 are two pockets 40 each defining a generally parallelepipedal cavity. The pockets are made of a tough flexible material. The longer dimensions of the pockets extend in the direction from the upper edge of the trapezoidal component toward the lower edge thereof. The two pockets are approximately parallel to the axis of symmetry 44 of the trapezoidal component and are symmetrically disposed at opposite respective sides of the axis of symmetry. Each pocket has four walls that extend generally perpendicular to the component 10 and a flap 46 that is an extension of one of the longer walls and is releasably attachable to the two shorter walls and the opposite longer wall using a zip fastener 48 that allows that pocket to be opened. The height of each pocket is sufficient to accommodate up to three spacers 50, each of which is approximately 1.3 cm in thickness. The spacers are made of a stiff rubber material. In use of the training aid to increase the weight level that is lifted in the bench press exercise, the lifter fits at least one, and generally all three spacers, in each pocket 40, releases the two clips 28 and fits the aid over his head with the two upper straps 18 over his shoulders, the ring 24 at his back and the trapezoidal fabric component over his chest. He can then pass the lower straps 32 under his arms and engage the clips 28. The lifter adjusts the slide buckles 20 and 34 so that the aid fits snugly with the component 10 positioned with the axis of symmetry 44 running down his sternum and the two pockets 40 substantially at the level of his shoulders. The pockets 40 are then positioned so that they traverse the location of the groove into which the lifter lowers the barbell during the bench press exercise. The lifter lies supine on the bench and grasps the barbell with the increased weight in its rest. The lifter then lowers the barbell in the usual fashion until the bar 52 just touches the training aid. The sensation of contact between the bar and the training aid is transmitted to the lifter's chest through the fabric of the training aid and the flexible spacers, and the lifter is able to tell readily whether the barbell is in the groove. Because the combined thickness of the three spacers in each pocket is about 3.9 cm, the bar is still at least about 4 cm from the lifter's chest. The lifter is aware from experience that the effort that he can exert on the barbell at a height of 4 cm above his chest is substantially higher than if the bar were actually touching his chest, and therefore he is not intimidated by the increased weight of the barbell, and furthermore, he is protected from injury due to excessive stress on the arm and shoulder. The lifter trains at the increased weight and with all three spacers in each pocket until he feels comfortable and confident and can execute the desired number of repetitions at the increased weight, and then he removes one or more spacers from each pocket. The lifter then trains at the lower number of spacers until he can comfortably and confidently execute the desired number of repetitions. This sequence of training with a given number of spacers in each pocket until a level of comfort and confidence is reached and removing at least one spacer from each pocket and resuming training at the reduced number of spacers is continued until all the spacers have been removed, at which point the lifter no longer requires the training aid and can train at the increased weight without need for the aid. In this manner, the lifter develops confidence at the increased weight progressively and with a reduced risk of injury to the arm and shoulder. In the second training aid, a set of, for example, three different sized spacer's is provided for each pocket, and only one spacer is used at a time in each pocket. A first spacer may have a thickness of about one inch, a second may have a thickness of about 1.5 inches and a third a thickness of about 2 inches. Referring to FIGS. 4 and 5, each 54 has a recess 56 having a depth of about one half inch in its upper surface. The lifter places two spacers 54 of the same thickness in the pockets respectively, with the recess 56 outward, and adjusts the slide buckles 20 and 34 so that the recesses are positioned at the location of the groove. When the lifter performs the bench press exercise, he is able to adjust the position of the barbell on the downward part of the movement so that the barbell partially seats in the recesses in the plates and thereby obtain confirmation that the barbell is in the groove. This reinforces the lifter's training, and assists him in learning the proper path of downward movement to attain a bottom position in which the barbell is in the groove. In use of the second training aid, the lifter initially trains at an increased weight level with the two thickest spacers in the pockets. When the lifter is comfortable and confident that he can execute the desired number of repetitions at the increased weight level, he removes the thickest spacers and replaces them with the intermediate spacers. The lifter then trains with the intermediate spacers until he can comfortably and confidently execute the desired number of repetitions, and he then removes the intermediate spacers and replaces them with the thinnest spacers. When the lifter can comfortably and confidently execute the desired number of repetitions with the thinnest spacers, he can train at the increased weight level without need for the training aid. With the second training aid, it is not necessary to place more than one spacer in each pocket, and this is advantageous because with fewer spacers, there is a reduced danger of misplacing a spacer. Moreover, a single spacer is more stable in the pocket than two or more spacers, which can slide against each other. A spacer with a groove, as described with reference to FIGS. 4 and 5, provides two different effective thicknesses, depending on its orientation. Preferably, a webbing strap 58 is attached to the trapezoidal fabric component 10 by stitching adjacent one side of each pocket. One part 60A of a strip of hook-and-loop fastener material, such as the material sold under the trademark VELCRO, is sewn to the free end of the strap and the other part 60B is sewn to the component 10 on the other side of the pocket. When a spacer 54 has been placed in the pocket and the zip fastener 48 closed, the lifter passes the strap 58 over the pocket and secures its free end to the component 10. The strap is positioned on the component 10 so that it fits at least partially into the recess 56 in the spacer and thereby stabilizes the spacer against movement relative to the component 10. The strap 58 assists the lifter in visually identifying the target for the lowering phase of the movement, since the strap is positioned in the groove. A training aid in accordance with the invention may be used not only in carrying out the bench press exercise, but also in carrying out the incline press and decline press exercises. The incline press and decline press are similar to the bench press except that the bench is not horizontal, and consequently the relative stresses on the different muscles are different. Thus, in the incline press, the shoulders are higher than the hips and this shifts the stress primarily to the deltoids and triceps. In the case of the decline press, the hips are higher than the shoulders and this shifts the stress primarily to the lower and outer section of the pectoralis major and to the anterior deltoids. It will be appreciated that the invention is not restricted to the particular embodiments that have been described, and that variations may be made therein without departing from the scope of the invention as defined in the appended claims and equivalents thereof. For example, the training aid is not restricted to the plates being attached to the harness by fitting in pockets, and other means for attaching the spacers to the harness may be used instead. In particular, the second training aid may be modified by attaching one part of a strip of hook-and-loop fastener material to the fabric component 10 by stitching and attaching the other part to a spacer using adhesive material, and the spacer can then be attached to the harness by engaging the two parts of the hook-and-loop fastener material. Further, the spacer may be permanently attached to the harness, in which case the lifter may have several harnesses with different thickness plates.

An exercise aid is composed of a harness which is worn on the lifter's chest when performing the bench press exercise and has left and right sides disposed at opposite respective sides of a central plane of the harness. The harness includes two pockets which are symmetrically disposed about the central plane. A stiff plate can be removably inserted in each pocket to provide a spacer which limits the extent to which the bar can be lowered.

[0001] This application is a National Stage completion of PCT/EP2009/009265 filed Dec. 23, 2009, which claims priority from European patent application serial no. 08022449.6 filed Dec. 24, 2008. FIELD OF THE INVENTION [0002] The present invention relates to methods, technical apparatus and compositions to achieve short term processing for the manufacture of a “smart” graft or transplant in form of a scaffold that can be used to treat or to heal injuries and traumas of a great diversity of tissues and organs in a central or peripheral location of the human or animal body. The invention specifically relates to tissue regeneration by means of stem cells and different specific tissue and organ repair promoting factors that activate said endogenous or exogenous stem cells to differentiate to specific tissue cells thus reconstituting the original microenvironment of the cell damaged by the injury. The invention also relates to a time scale of processing that is so short that it can be done within a matter of minutes including stem cell preparation and stem cell integration, stem cell activation and commitment. Depending upon the size of the defect the stem cells will be added for large defects but also sufficiently recruited locally in smaller defects. A combination of both cell recruitment options is possible to ensure continued regeneration over a period of several weeks inside the body until complete restoration of tissue morphology and function has resulted. [0003] In particular, the present invention relates to a novel method capable of initiating an excellent stem cell preparation process, that is so short that it applies to a time frame of a few seconds to several minutes. [0004] The method is based on the concept of extracorporeal triggering of a niche formation that allows stem cells to be guided for remodeling ex vivo/in vivo and in situ without the need for any in vitro expansion or protracted culture processes. This novel method allows to generate templates that will remodel spontaneously into the targeted tissue of choice after completion of the extracorporeal processes. The invention is directed to almost all kinds of human or animal tissue. [0005] The invention relates finally also to compositions and formulation or scaffolds coated with said compositions comprising (i) stem cell preparations, (ii) erythropoietin (EPO) and (ii) factors that promote differentiation of stem cells, (iv) factors that increase availability of stem cells, and optionally (v) factors which are usually present in the environment of a local trauma. [0006] The invention can be used for rapid and safe preparation of individually engineered grafts, transplants or implants preferably in form of a scaffold for rapid, high quality and economical tissue regeneration. BACKGROUND OF THE INVENTION [0007] Tissue engineering of implants is a long and risky process with respect to maintaining sterility, which implies procurement of cells from the donor, transfer of the cells to a laboratory and manipulation of such cells to initiate expansion and/or differentiation. Following the expansion period cells are frequently removed from a temporary attachment substrate by i.e. trypsinization and thereafter transferred onto a scaffold and again cultured on this scaffold. This process therefore requires often not only days but weeks to be effective. [0008] The rapid and correct manufacturing of complex 3D grafts is presently not known in the art. It is fundamental and indeed contradictory to current teaching, which focuses on cell technologies to expand and differentiate cells to trigger commitment in vitro and by seeding them thereafter onto scaffolds or growing them on these scaffolds directly. It is expected that those cells differentiate in vitro. This process often requires at least 1-2 weeks in average or even more. [0009] A second line of teaching uses injecting methods for undifferentiated stem cells from bone marrow or blood or crude bone marrow as a form of cell therapy intra-operatively directly into a tissue including e.g. the heart muscle. For the repair of spinal injury cells were either cultured for expansion or from specific sources such as the nose or embryonic origin. The latter have the risk to go into transformation or tumor formation. The nose derived cells represent a rather infectious environment for harvesting and could not convince clinically as a generic solution. Bone marrow derived cells are under investigation. [0010] A further alternative is de novo tissue regeneration. It was expected that the local environment will eventually help to differentiate these cells. Examining the receiving environment more closely it is found that the cells do not differentiate into e.g. heart muscle cells after injection into the heart. In these instances no formation of muscle cells was reported at all. Instead a rather positive effect from the secretory activity of the transplanted stem cells for support of recovery was postulated. Overall effects in such studies was a 4% improvement of cardiac function only. This means that this microenvironment hypothesis does not achieve the goal of tissue de novo formation but has an adjuvant role only. [0011] In another study expanded MSC were injected after expansion in vitro into a acellularized valve scaffold. During in vitro culture cells underwent a selection process that achieved to select cells that have a prominent stem cell character (stronger replication) and that may lead to a reduced inflammation in vitro. [0012] So far it is not clear what roles cytokines may play in this context. However it is well known from prior art that molecules in vitro can be used to control multipotency and to induce differentiation and commitment to a specific tissue. [0013] Wound healing is closely linked to inflammatory responses. After surgical implantation of an artificial trachea the speed and quality of local healing, survival and integration is crucial for graft take and the long term success of the implant. [0014] During inflammation cytokines are released such as IL-6, IL-1 and TNF that sustain the inflammatory response. Inflammation nevertheless can be a two-edged sword, if inflammation is not terminated in due course due to insufficient remodelling of the implant scaffold. [0015] Scaffold remodeling in tissue engineering was conceived of as a rather unknown process and triggering mechanisms were either obscure or clinically not feasible. Conventionally cells would have been seeded onto the material of choice and integration into this material was a process that was attributed to ideally cell expansion time and migratory penetration. [0016] Fundamentally, there is a positive side to inflammation being a perquisite for healing that needs to be taken into consideration for biological-implant engineering. [0017] The prior art does not provide adequate teaching on the controlling either of the microenvironment after transplantation of the graft for sustainable remodeling, differentiation of undifferentiated cells after transplantation and of stem cells sensing the wound zones and does not teach adequately the differentiation of transplanted cells after expanded in vitro to achieve true scar free healing. [0018] Such pre-expansion has been shown to activate oncogenes. This is caused by the exposure to an artificial environment and possible also to repetition of proliferation cycles that do not underlie normal control mechanisms of wound repair and remodeling. This artificial situation of course is not coherent with the body's capacity for regeneration following wounding and injury. Stem cell activation in man and stem cell commitment requires a full control of proliferation, while at the same time preventing oncogene activation. [0019] These requirements are considered to be mandatory and their disregard in conventional teaching can cause the most severe and deleterious drawbacks of the current technology of in vitro cellular processes that inevitably are not only rather complicated but also risky for these reasons. [0020] The other alternative represents a mere injection of stem cells, which is on the other hand no solution since the receiving site of the cells is highly variable and not fully controllable from the cell and scaffold transplanter's side. In all cases reported so far stem cells were at a closer look not fully achieving their original goal of resulting in an appropriate de novo tissue formation. [0021] Accordingly there is need for controlling multipotency of stem cells after transplantation and at the time of transplantation. Past teaching was focusing on controls of multipotency rather before transplantation. A need also exists to avoid cell culture processes that may attempt to control cell differentiation but exhibit artificial side conditions that are harmful to the cells and are also not economical. [0022] It is a great problem in carrying out these prior methods with respect to the quality and functionality of the transplant. Accordingly, there is demand for a method of abolishing all these limitations. The present invention was made in order to overcome the problems described, and to provide a practical method to rapidly engineer airway tissue and valves and in general all tissues of the animal or human body. SUMMARY OF THE INVENTION [0023] To solve the problems of cell culture or “blind” transplantation of cells, the present invention provides a new method and approach for controlling stem cell differentiation, rapid preparatory process of implants ex vivo, and implantation of these pretreated implants in vivo by a surgeon at the same time. [0024] This all can be achieved by selecting a specific target: the stem cell which is specifically treated according to the invention. [0025] It was found that endogenous or exogenous stem cells or progenitor thereof can be activated in injured tissues and artificial or natural scaffolds by exposing them to the conditions of a natural microenvironment. It was found that this microenvironment is damaged when larger injuries occur. In such a situation the necessary cells and factors are missing in the local environment of the damaged tissue or have lost their activity or efficacy. According to the invention, this microenvironment can be retained if the tissue to be regenerated or repaired or the respective tissue scaffolds or matrices are exposed to the necessary cells and tissue repair supporting factors. In this situation also endogenous factors, such as cytokines or other inflammatory factors, which are usually secreted into the wound, may assist and promote this tissue repair process. According to the finding of the invention stem cells, preferably CD90 positive stem cells, play here an important role. However, these stem cells need to be activated with respect to their capability for specific differentiation in order to generate new specific tissue without scaring or other undesired effects. [0026] Activation of stem cells in situ can be done according to the invention with several different factors which support the achievement of and retaining of the optimum microenvironment of injured tissue thus promoting improved differentiation and growth of regenerated locally specific tissue. [0027] A first group of supporting factors as defined by the present invention are stem cells or progenitor cells thereof, which have the capability to differentiate into any type of tissue cells, including cells of neuronal and lymphatic tissue. These factors are called “cell factors”. These stem cells or progenitor cells thereof can be assisted according to the invention by peripheral blood monocytes (PBMC), by CD90 positive cells, or by CD45 positive cells. [0028] A second group of supporting factors acting in this way are factors which stimulate stem cells and accelerate remodeling of tissue cells. These factors are called “boosting factors”. These factors are no growth factors as it is usually understood by a skilled artisan. The preferred boosting factor of the invention is erythropoietin (EPO) [0029] A third group of supporting factors according to the invention are designated “commitment factors” which support the differentiation of stem cells. The preferred commitment factor for cartilage differentiation of the invention is the combined use of TGRβ. [0030] A fourth group of supporting factors according to the invention increase the availability of stem cells, which means an increase of the number of stem cells both in the peripheral and local environment of a tissue injury, and are called “recruitment factors”. The preferred recruitment factor of the invention is G-CSF. [0031] A fifth group of supporting factors according to the invention are designated “permissive factors”. These factors, such as cytokines, are usually already present in tissue with local trauma or are secreted endogenously during inflammation accompanied by a local tissue injury. [0032] According to the finding of the invention the factors of the first, second, third and fourth group are mandatory according to the invention and must be delivered to the location of the tissue injury or to the scaffold provided for transplantation into the injured tissue by exogenous application. The permissive factors can be applied optionally. [0033] According to the invention the transplantation of stem cells or the induction of endogenous stem cell activation is accompanied by an exposure to a portfolio of factors. None of those factors alone permits the completion of the circle of events leading to scar free healing and remodeling. However they are important additions to control the multipotency of the cells acting in a concerted action amongst each other. [0034] The availability of those factors can be done in at least three variants: A) addition during the cell application or cell activation phase (e.g. as lyophilisate to avoid dilution of the stem cell bone marrow concentrate) B) Addition to the scaffold during the production phase. A preferred way is the integration during the production of scaffold and integration into the material. This may be done be e.g. addition to biological scaffolds during a lyophilization procedure of the factors together with the scaffold matrix (e.g. collagen, chitosan, blood and blood components) or during an electrospinning process, the advantage being an intricate formation and combination and a non-damaging way of use, good storage capability) C) use of an ideally autologous substitute. Many of these factors, especially the commitment factors occur in the healthy tissue. A technique of mincing small biopsies and distributing them into the stem cell coating into the stem cell concentrates is preferred. A combination with a platelet concentration, the mincing results (e.g. fragments from cartilage, meniscus, tendons, skin, heart, sphincter tissue, valve or aortic tissue and indeed any other tissue) represents an important triggering event and is a valuable alternative and/or an addition to the isolated use of individual factors. Not all of them are available clinically at this time and need further development for clinical applicability. [0035] In a first aspect of the invention a natural or synthetic scaffold mimicking the injured specific tissue is used. This scaffold material serves as a copy which catalyzes the process that finally results in the matrix of the tissue to be generated. In a specific embodiment of the invention this scaffold material contains individual specific tissue to be generated taken by a biopsy from the patient suffering from an injury or a tissue defect. The scaffold is coated, or partially or selectively loaded with the above-specified factors (including “cell factors”) in vitro or ex vivo. In a specific embodiment of the invention the treatment of the scaffold with factors and optionally individual specific tissue from the patient occurs intraoperative, that means in temporal conjunction with surgery of the patient. Preferably, the factors and/or the scaffolds are pretreated according to the invention before combining them. [0036] In a second aspect of the invention the factors as specified above are brought directly to the injured or defect tissue in the patient without a separate artificial or natural scaffold pretreated with the specific combination of factors. In this case, the factors are preferably formulated as a gel or glue composition which is filled in the tissue defect or wound in order to seal it. [0037] The main advantage of this approach is, that the need for stem cell expansion and predifferentiation before transplantation is abolished completely. In addition the best quality of the implant is achieved as measured by histology and function following remodelling. A further advantage is the site specific mode of action of the commitment factors, that avoid systemic side effects. According to this teaching it is the local presence of permissive factors that together with the exogenously administered boosting factors allow an extremely rapid graft preparation to be done. A further result of the invention is that the scaffold used is remodeled faster and more efficiently by 40-50% over a control that is prepared in a conventional manner. [0038] In a preferable embodiment of the method stem cells are obtained during the same session or operation that is used for the implantation. [0039] The invention is so fundamental that it allows to overcome evolutionary barriers with respect to speed, quality and size of defect repair and tissue replacement. It allows neotissue formation and repair in situations that cannot be repaired by the body and allows phenomena to be achieved that do not occur normally in the human or animal body. The fundamentality of the invention therefore opens all necessary applications for all human and animal tissues of all kinds, as it is focused on a basic platform technology that works with all tissues by inducing favorouble wound healing conditions in disease states that could otherwise not be repaired normally or artificially. [0040] The fields of applications include all disease states with ischemica, inflammation and defects of such a size that they either cannot heal spontaneously or if a closure would occur it would result in a scar tissue. A scar tissue is an indication of low quality defect healing that cannot reassume normal or original tissue function. This is important for any tissue in the body. [0041] The invention can be used to treat, for example, spinal cord injury or to be interponed to heal a disconnected, injured or traumatized nerve tissue in a central or peripheral location of the human or animal body. It relates to an autologous implant preparation, stem cell signalling to induce tissue remodelling of a specific graft, but not limited to these tissues as it may apply also to further neuronal tissue (nerves, spinal cord, brain stroke, brain trauma) skin, eye, cornea, muscle (heart, sphincter tissue, sceletal muscle, vascular tissue muscle), vascular system (veins, arteries, capillaries), skin, lymphatic tissue, bladder, urethra, penis, ovaries, to a trachea, a heart valve, a urological tissue, a bone or a cartilage substitute or all other tissues of the human body. The reason for this applicability is, that it functions as a concerted action of stem cell handling that allows to achieve repair as a coordinated interplay of cells, materials and signalling. [0042] The following generic protocol forms according to the invention the basis to achieve a complete remodeling using a scaffold. This protocol is not limiting the invention: single steps can be repeated, amended, dropped, added, replaced, or carried out in different sequence, if necessary. Sequence step in the method of the present invention in combination with the apparatus (self contained production mobile unit, MU) (i) preparation of the scaffold in a sterile manner. The material serves as a material for initiating a copy process that finally results in the matrix of the desired tissue to be generated The scaffold may be synthetic, such as a collagen fleece or from natural origin (e.g. a swine valve); (ii) sterile collection and preparation of adult/mesenchymal stem cells (“cell factors”) from suitable sources, such as peripheral blood or bone marrow, by concentration or buffy coat preparation; (iii) sterile collection of peripheral blood derived monocytes (PBMC) by concentration or buffy coat preparation; (iv) incubation of the stem cell concentrate with a boosting factor according to the invention, preferably EPO, thus obtaining pretreated stem cells. (v) incubation of the natural or artificial scaffold with a boosting factor according to the invention, preferably EPO; (vi) integration or injection of collected pretreated or optionally untreated stem cells into/onto the pretreated or optionally untreated scaffold in vitro/ex vivo in a diffuse or patterned form depending on the desired structure to be generated (e.g. cartilage, bone, valve or others). In tubular systems injection of the pretreated stem cells occur into/onto the areas underneath the superficial; (vii) integration or injection (as specified under (vi)) additionally of tissue cells (e.g. epithelial cells) obtained by individual biopsy from the injured or defected patient's specific tissue to be regenerated, into/onto said scaffold; (viii) incubation of said pretreated or optionally untreated scaffolds with a boosting factor (preferably EPO) and commitment factor (preferably TGFβ) and a recruitment factor (preferably G-CSF), or alternatively only with a commitment factor and a recruitment factor, optionally by means of a gel-like or glue-like composition/formulation comprising said factors; (ix) incubation as specified under (viii) optionally additionally with a PBMC preparation; (x) Preparation of tissue specific fragments (e.g. minced cartilage from the recipient, epithelium or others for co-coating of the implant. (xi) Use of a bioreactor or closed device for inoculation and positioning or mixture of cells with the implant scaffold (eg. bone, valve, collagen fleece) for GMP and automation requirements if necessary. (xii) providing the so-prepared scaffold to the surgeon for implantation into the injured or defected tissue location of the patient. (xiii) Intraoperative and in situ coating of implants from the sites that are accessible to reduce loss of cells. Cell-gels are applied topically after induction of clotting in the stem-cell bone marrow concentrate. Cell gels contain one or more boosting, commitment and recruitment factor(s) [0056] The steps (i)-(ix) are carried out according to the invention in a laminar air flow cabinet or respective bioreactor or closed device, preferably in temporal conjunction with surgery within 10-30 minutes without cell replication or interim transport needs (all done in the same operating theatre). [0057] After implantation, it is preferred according to the teaching of this invention to treat the implanted scaffold with gel-like or glue-like compositions comprising preferably all factors: cell factors (stem cells), commitment factors, boosting factors, recruitment factors and optionally permissive factors as defined according to the invention. The composition are applied in situ above at all sites that are accessible to reduce loss of cells. [0058] The method as described above creates a regenerative cascade that allows remodeling of in situ matrix or co-administered scaffolds. The injections/incorporations carried out with said gel or glue composition comprising cells and factors as described creates a depot slow release effect, which is effective during the in vivo healing process. [0059] Injections (e.g. also without coadministration of cells into joints) create a regenerative cascade that allows remodelling of in situ matrix or coadministered scaffolds. [0060] In a further and completely new aspect of the invention a method fully respecting sociological and regulatory prerequisites by providing a technology that dramatically accelerates the speed of preparation of the implant, intended for surgical implantation onto the patient. This concept follows the bionic principles of the human body ( FIG. 1 ). The manufacturing of the graft should not require 2-3 weeks according the prior art teaching, but can be carried out within minutes less than one hour to make different kinds of desired tissue. The whole process is ideally done intraoperatively and therefore eliminates the need to send the respective cells to laboratories. This solves limitation of logistics, unnecessary anesthesia and costs including time that can be saved by this intraoperative implant engineering process. In the hands of the doctor treating the patient and not leaving the operating room, the process fully complies with current regulatory and quality requirements. Thus, the implant is not the particular product which is separately handled, but the process to make the implant as part of the therapy. This is the safest methodology existing with respect to avoiding transformation and infectious risks thereby providing increasing quality. The scaffold to be used according to the invention is able to react to remodeling stimuli and, preferably, it is prepared by using fully closed GMP compliant one-way devices as principally known and used in the art. This technology is characterized above all by the fact that in vitro cell replication is completely avoided by using and applying the above specified factors, which are: cell factors (“the cells”), boosting factors (preferably naturally occurring biological molecules, such as EPO or GH), commitment factors (preferably naturally occurring biological molecules, such as TGFβ, VEGF, hormones or vitamins), recruitment factors (preferably naturally occurring biological molecules, such as G-CSF, GM-CSF) and optionally permissive factors (preferably naturally occurring biological molecules, such as trauma cytokines). The result of this approach is fast, efficient and perfect remodeling of defect or injured tissue, that is 40-50% faster over respective approaches that do not use said stimulating supporting factors. The new bionic technology concept as presented herewith benefits from the innate mechanisms of specific wound repair using them as co-triggering events, and the body's capacity to formulate a site-specific response, independent from the type and location of a tissue. [0061] One of the advantages of the invention is that the application of EPO to the scaffold is results in a faster expansion of endothelial and smooth muscle progenitor cells from the surrounding areas to populate the scaffold. The technique employed alternatively refers to intermingling normal target cell structure or tissue fragments into the stem cell preparation to enhance paracrine signalling. [0062] Subject matter of the present invention is also a method for healing injured, traumatized or defected tissue in a patient, thereby achieving restitutio ad integrum, wherein healthy cells from the tissue to be treated serve as copy cells, the method comprising the steps: [0000] (i) recruiting autologous stem cells obtained from the patient to be treated by withdrawal from bone marrow, blood or other tissues; (ii) recruiting healthy surrounding or surviving cells as co-differentiating cells obtained from the defected, traumatized or injured tissue or the environment thereof, (iii) applying to the patient by intravenous, subcutaneous or topical administration a composition or formulation comprising (A) the stem cells of step (i), (B) the healthy tissue cells of step (ii) and (C) a preparation comprising (a) at least one factor that stimulates stem cells and accelerate remodeling of tissue cells, (b) at least one factor that is able to control and direct differentiation of said stem cells, and (c) at least one factor that increases the number of stem cells both in situ and in the peripheral circulation. [0063] In summary the invention relates to the following topics: An ex vivo intraoperative method for manufacturing an individually engineered implant based on a natural or synthetic scaffold serving as a copy matrix for the tissue to be generated as a result of a tissue defect or tissue injury in a patient, the method comprising the steps: (i) providing a natural or synthetic scaffold as supporting matrix for the growth of tissue cells; (ii) providing autologous stem cells obtained from the patient to be treated; (iii) providing healthy cells as copy cells obtained by biopsy from the defected or injured tissue of the patient to be treated; (iv) incubating the stem cell preparation of step (ii) with a composition comprising a factor which stimulates stem cells and accelerates remodeling of tissue cells; (v) loading or injecting the cell preparation of step (iii) onto or into the scaffold matrix; (vi) incubating the pretreated scaffold matrix of step (v) in the presence of the pretreated stem cell preparation of step (iv) together with a composition comprising (a) a native factor recruiting and increasing the availability of stem cells, (b) a native factor that promotes differentiation of stem cells or its progenitor cells, and (c) the factor of step (iv); and (vii) providing the so treated scaffold for implantation into the patient to be treated by a surgeon, wherein steps (iv)-(vi) are carried out under sterile conditions in a bioreactor chamber or a laminar air flow cabinet during a period of 10 to 30 minutes. The method as specified above, wherein the autologous stem cell of step (ii) and/or the tissue copy cell preparation of step (iii) was pretreated with a composition comprising (a) a factor recruiting and increasing the availability of stem cells, (b) a factor that promotes differentiation of stem cells or its progenitor cells, and optionally (c) a factor which stimulates stem cells and accelerates remodeling of tissue cells. The method as specified, wherein the factor that stimulates stem cells and accelerates remodeling of tissue cells is selected from the group consisting of EPO and hGH, and wherein the factor that recruits and increases the availability of stem cells is selected from the group consisting of G-CSF and GM-CSF, and wherein the factor that promotes differentiation of stem cells or its progenitor cells is selected from the group consisting of TGRβ, VEGF, vitamin C, and vitamin E. The method as specified, wherein the factor that recruits and increases the availability of stem cells is G-CSF, the factor that promotes differentiation of stem cells or its progenitor cells is TGFβ, and the factor which stimulates stem cells and accelerates remodeling of tissue cells is EPO. A method as specified, wherein the stem cells are obtained from bone marrow or peripheral blood of the patient to be treated, and preferably have not been expanded before by a separate process step. A corresponding method, wherein the incubation step of step (vi) includes addition of autologous peripheral blood derived monocytes (PBMC). A method as specified, wherein the steps (iv)-(vi) are carried out simultaneously with the prearrangement of the patient to the implantation of the scaffold into or onto the defected or injured tissue. A method of any of the claims 1 to 11 , wherein the different factors and/or the different cells as specified in any of the preceding claims are provided to the scaffold by a viscose gel-like or glue-like formulation or composition. A use of a scaffold obtained by a method as specified, for the manufacture of an implant for healing injured or defected tissue, thereby achieving restitutio ad integrum. A respective use, wherein a viscose, gel-like or glue-like formulation or composition of the different factors and/or cells as specified in any of the preceding claims is provided for intraoperative in situ treatment of the freshly implanted scaffold at all or some selected sites of the defected or injured tissue. The use of a preparation or composition comprising (i) freshly prepared non-expanded autologous stem cells, (ii) a factor that stimulates stem cells and accelerates remodeling of tissue cells selected from the group consisting of EPO and hGH, (iii) a factor which recruits and increases the availability of stem cells selected from the group consisting of G-CSF and GM-CSF, and (iv) a factor that promotes differentiation of stem cells or its progenitor cells selected from the group consisting of TGFβ, VEGF, vitamin C, and vitamin E, for the manufacture of a medicament for the treatment of injured or defected tissue in a patient without or together with an implanted specific cell growth supporting scaffold, thereby achieving restitutio ad integrum. The use as specified, wherein the preparation or composition or the scaffold comprises additionally healthy cells from the defected or injured tissue of the patient to be treated serving as copy cells, and optionally autologous PBMC, said cells were preferably pretreated with EPO and/or G-CSF and/or TGFβ. The use as specified, wherein the composition or preparation is provided in a viscose, gel-like or glue-like formulation, which is applied to or injected into the defected or injured tissue at all or some selected sites, wherein preferably said formulation consists of blood, plasma or bone marrow, bone marrow concentrate, which is applied to or injected into the defected or injured tissue at all or some selected sites and induced to polymerize by addition of Ca++ or thrombin or other suitable polymerizing compounds. A corresponding use, wherein the scaffold was pretreated with healthy cells from the defected or injured tissue of the patient to be treated, and optionally with autologous PBMC, and/or wherein the stem cells were pretreated with EPO and/or hGH. The use as specified, wherein in case that a scaffold is applied, the preparation, treating and pre-treating of respective cells is intraoperatively achieved simultaneously with the surgery in a rapid process within a few minutes less than one hour. The use as specified, wherein in case that no scaffold is applied, the composition or formulation of respective cells and factors is provided for systemic administration by intravenous or subcutaneous administration, or if the tissue to be treated is available by direct topical administration. A method of intraoperative preparing of autologues cells that induce, stimulate and promote differentiation and growth of tissue cells in defected or injured tissue by means of a natural or synthetic scaffold in a patient, while prearranging and treating the patient for implantation of said scaffold into said patient, wherein said cells are (a) autologous stem cells from bone marrow, tissue or blood of a patient suffering from a tissue defect, tissue trauma or tissue injury, and (b) healthy tissue cells as copy cells for coating the scaffold matrix to be implanted into the patient, the method comprising the steps: (i) identifying the site of damage in the patient; (ii) recruiting autologous stem cells from the patient to be treated by withdrawal from bone marrow, blood or other tissues; (iii) recruiting autologous tissue cells from the patient to be treated by biopsy of healthy surrounding or surviving cells from the defected or injured tissue; these cells serving as template cells on the scaffold matrix; (iv) treating the stem cell concentrate of step (ii) ex vivo without having expanded them, with EPO or hGH or other factors that stimulate stem cells and accelerates remodeling of tissue cells for 10-30 minutes in a bioreactor or a laminar airflow cabinet located in the operation room under sterile conditions; (v) treating the template cells of step (iii) ex vivo, with at least one factor selected from the group consisting of EPO, hGH, GM-CSF, G-CSF, and TGFβ for 10-30 minutes in a bioreactor or a laminar airflow cabinet located in the operation room under sterile conditions; (vi) coating or injecting the scaffold ex vivo with the pretreated cells of steps (iv) and (v) for 10-30 minutes in a bioreactor or a laminar airflow cabinet located in the operation room under sterile conditions; (vii) prearranging the patient for implantation while carrying out steps (iv) to (vi) (viii) implanting the partially or completely coated scaffold of step (v) into the tissue defect or wound; and optionally (ix) applying by topical administration a gel-like or glue-like composition or formulation onto the implanted scaffold and onto the tissue in the environment of the implant, wherein said composition or formulation comprises the cells of steps (ii) and (iii) and one or more of the factors of step (v). A method as specifies above, wherein a composition or formulation comprising at least one factor selected from the group consisting of EPO, hGH, GM-CSF, G-CSF, and TGFβ was applied to the patient in an pharmacologically effective amount by systemic administration before starting the operation with step (i). DETAILED DESCRIPTION OF THE INVENTION (A) Definitions [0102] The term “supporting factors” as used in this invention is comprised of a group of factors consisting of: “cell factors”, “boosting factors”, “commitment factors”, “recruitment factors” and “permissive factors”. [0103] The term “cell factors” is related in particular not really to factors like growth factors and the like, but to specific cells, which elicit or have retained their capability to differentiate to tissue cells of specific phenotype and with specific biological function. The very preferred cell factors or cells according to the invention are all kind of stem cells such as embryonic stem cells or adult stem cells such as mesenchymal stem cells, for example, obtained from peripheral blood or bone marrow cells. Stem cells are present in all tissues being CD90 positive. These cells can be isolated by collagenase digestion from skin, liver and heart tissue amongst most other tissues. The cells do not only express CD90 but also other markers found typically in bone marrow cells. [0104] The cells however do not only express the receptor for erythropoietin but also for its subunit beta-cR. Beta-cR is a target for EPO and it's remodeling activity of extraclleluar matrix in CD 90+ Cells. This shows that a co-expression of the beta-cR exists in tissues such as skin, spleen and kidney in parallel to the expression of the growth hormone receptor GHR. The expression of the beta-cR is indeed found in all tissues together with the GHR. Thus, all cells expressing the beta-cR are suitable “cell factors” according to the invention. The expression of the beta-cR is indeed found in all tissues together with the GHR. In FIG. 1 the expression of the beta-cR and growth hormone is shown in skin, spleen and kidney in an exemplary way as it is not limited to these tissues but generically coexpressed [0105] The term “smart graft” or “smart scaffold” means a highly specific tissue template that senses a wound environment into which it is implanted and reacts accordingly using this environment to achieve it's own remodelling to a specific target tissue by stem cell activation leading to a high quality scar free tissue specific result [0106] The term “boosting factors” as used in this invention describes respective preferably natural biological molecules that stimulate the above-mentioned receptors on CD90 positive cells, preferably stem cells. The purpose of these “boosting factors” is to enhance remodeling, to reduce inflammation and to activate stem cells to propagate and to protect against ischemia and other tissue damages. The group of factors includes besides erythropoietin thrombopoietin and HGH. This includes also derivatives and peptide sequences of erythropoietin that eg. stimulate the beta-CR subunit of the erythropoietin receptor, the receptor of TPO or the growth hormone receptor. Inflammatory cytokines exhibit a stimulatory effect on mesenchymal stem cells, when co-stimulated in the presence of erythropoietin In this situation CD90 positive stem cells (fibroblast like progenitors) could be triggered to be activated in vitro. Erythropoietin alone has no triggering effect on fully differentiated cells, which means it does not act as a growth factor would typically do, but has according to the invention a sensing role linking a trauma dependent stem cell activation to a regenerative growth response. This means, that a site specific activation process is provided by the local wound environment at the time of transplantation. The human body apparently is able to react to localized trauma by triggering a site specific response that leads to repair. The knowledge for site specific repair must be linked to the combined mode of activity of trauma cytokines and boosting factors. According to the present invention the “boosting factors” are ideally co-transplanted by either pre-incubating the cells during the preparatory phases or by integrating them (full thickness, micro-patterning) and or positioning them together with other supporting factors into the scaffold for transplantation. Thereby the scaffold becomes a material that can release signaling factors to the cells at the time of inoculation and ideally during the total or partial period of duration of its existence. This represents a protracted release mechanism. Examples for suitable boosting factors according to the invention are: EPO, TPO and human growth hormone (HGH). [0107] The term “recruitment factor” means according to the invention, preferably but not limited thereto, a natural biological molecule that is able to increase the number of stem cells both in situ and in the peripheral circulation. Recruitment factors can be added in addition or alternatively to in situ loading of the graft with intraoperatively prepared stem cells. [0108] The term “commitment factor” means according to the invention, preferably but not limited thereto, a natural biological molecule that is able to control and direct differentiation, preferably in situ rather than in vitro, of stem cells, progenitor cells thereof, and cells which are not fully differentiated. Examples for such a factor according to the invention are: some hormones, vitamins such as vitamin C, A, and E, TGFβ and VEGF. [0109] The term “permissive factor” means according to the invention, preferably but not limited thereto, a natural biological molecule that is usually present or generated during inflammation of a wound, such as the typical trauma cytokines. In vitro these trauma molecules are usually not present and can be additionally added to the cells obtained and treated by the teaching of this invention. Another permissive factor is constituted by ischemia itself. These molecules and conditions indicate site specificity and need and contribute permissive factors for stem cell activation in the simultaneous presence of the supportive and commitment factors. This indicates why this process is so rapid to induce remodelling of the graft and represents a powerful tool box to achieve graft remodelling if applied simultaneously according to the teaching of the present invention. In case of chronic or degenerative conditions that lack inflammatory conditions or in the absence of any trauma or injury there are at least two ways according to the invention that are used to achieve a full panel of stem cell stimulation: A) coadministration of trauma cytokines such IL-1, TNFalpha, IL-6 in very low and preferably topically restricted ways. This includes e.g. coating or intregration in the scaffolds used. B) In minor cases (regarding the defect size to be regenerated) mechanical stimulation with e.g. a needle, superficial rubbing for reddening, UV exposure, laser exposure, and knife cutting results in a endogenous release of such permissive factors. This process must therefore be done simultaneously to the application of the other factors and with and without the stem cells. [0110] The possible problem of the availability of the factors according to the invention can be circumvented by using freshly harvested autologous tissue cells obtained from the tissue to be generated or healed of the same patient. These tissue cells can be applied in form of mingled tissue pieces, which can be added to the stem cell concentrate or composition provided for implantation, coating the scaffold or systemic administration solely or in addition implantation. [0111] Each and all of these factors and their use according to the invention may overcome the problem of limitation of a “blind” transplantation into a tissue environment or a synthetic or biological/natural scaffold. [0112] The term “intraoperative” or “intraoperative process” or “intraoperative implant engineering process” according to the invention means a process, wherein preparation of the implant/scaffold ex-vivo and surgery of the human or animal body at the site where tissue is defected, traumatized or injured is accomplished in principle in parallel, including biopsy of respective cells for loading the scaffold ex vivo in timely conjunction. That means that ex vivo activities regarding stem cell or other cell preparation and pretreatment thereof including incubation of the supporting matrices (scaffolds) are started shortly before or simultaneously before surgery of the diseased tissue, organ, joint etc. and ends after having implanted the scaffold loaded with cells and factors as describes above at the latest. The term also includes the application of the so-obtained or so-treated cells and factors in form of a suitable composition or preparation, preferably as a gel or glue formulation, for treating the implanted scaffold and the tissue environment around the implant and the defected or injured tissue surrounding the freshly implanted scaffold. (B) Description of Details and Specific Embodiments [0113] The invention is characterized by the fact that the cells are cotransplanted with a diversity of different factors as specified above. These factors are acting according to the teaching of the invention in situ and control and induce differentiation and growth in situ too. [0114] According to the invention the factors are administered preferably topically in combination with a scaffold ex vivo and/or in vivo and simultaneously with and without the presence of exogenously administered (stem) cells. It is also possible to apply only some of the factors mentioned above. Furthermore, in a preferred embodiment of the invention the factors, as well as the respective cells (stem cells, patient's tissue cells) can be administered solely or together with a preferably pretreated scaffold/implant by systemic administration applied to the patient to be treated in good time (1-5 days) before surgery and starting the process according to the invention. [0115] The invention is further characterized that, by applying the factors according to the invention, it fully avoids to perform an in-vitro culture that includes any expansion of cells, including stem cells. An advantage of this embodiment is that the time frame needed for the cell preparatory phase can be shortened to a matter of minutes thus eliminating the disadvantages of cell expansion and cell differentiation in vitro. If there is no cell replication in vitro risks are significantly reduced and/or abolished. On the other hand this embodiment allows control of differentiation in situ at the trauma (implant site) in combination with a boosting factor exposure, like EPO. [0116] The single factors as specified by the invention interplay with each other and the cells, preferably the stem cells in situ at the trauma site: [0117] The factors are used to coincubate the progenitor cells at the time of transplantation, or can be used to coat directly the scaffold. A “commitment factor” as specified by the invention can thus be applied also in a patterned way to a scaffold. In a collagen or hyaluronic/or chitosan sponge TGF beta 1, 2, or 3 is used to trigger mesenchymal stem cell differentiation at the implant site. Thus the interaction of boosting and commitment mechanisms is facilitate leading to significantly faster and qualitatively higher form of tissue regeneration. The difference is explained by the fact that conventionally differentiated cells in case of cartilage cells derived from MSC (mesenchymal stem cells) need 2-4 weeks to be prepared before implantation. Still thereafter cells loose not necessarily maintain their differentiation in vivo following implantation. Is is well known in the art, that normally cartilage generated in vitro or in vivo dedifferentiates to fibrotic tissue within a few months. According to the invention high quality hyaline cartilage results that is maintained in animals for at least 1 year (equivalent to 5-7 years in man). The technology according to the invention results in a faster preparatory phase (eliminating completely week long cultures), it is better from a quality point of view (fibrosis/scar free) and it is more economical from a production point of view. The cellular production complies with GMP (good manufacturing product condition). [0118] In a tracheal scaffold, for example, the cartilage rings have a circumferential arrangement and a broadness of 3-4 mm. Here every very few millimeter another differentiation zone can be marked. Thus, a combination of factors according to the invention, for example commitment factors, can be used for patterning scaffolds. One commitment factor is e.g. vitamin C that can be patterned in areas in between cartilage rings to support matrix synthesis and development. Another example for a commitment factor is IL-15 that supports bronchial epithelial development and can be positioned in the lumen of the tracheal scaffold. [0119] As outlined above boosting factors, such as EPO or GH are by definition cooperating with local trauma conditions and react towards them in a responsive way. As a matter of completeness, this is explained by the expression of trauma cytokines, which is known in the art, (J Trauma, 2008, vol. 65, n° 6, pp. 1374-1378,). There is a physiologic occurrence of these factors including trauma cytokines. IL-12 (p70), and IL-18 and Th2-type cytokines IL-4, IL-10, and IL-11 were determined using the enzyme-linked immunsorbant assay technique in patients and in healthy controls. IL-2 and interferony were seldom detectable. All other mediators were significantly increased matched to controls (p<0.05). All cytokines were elevated most prominent during weeks 1 and 2 posttrauma and declined thereafter. Other cytokines include IL-1, IL-6 and TNF alpha, and support the boosting effect of EPO/TPO and Growth hormone. The permissive factors allow CD90 cell generation in trauma areas upon EPO (boosting factor) stimulation scar free healing. This is relevant, for example, for cardiac ischemia, spinal cord injury, cartilage repair, tendon regeneration and all other tissues as it means “restitutio ad integrum” rather than defect (scar like healing). [0120] An important function of the factors according to the invention, such as the boosting factors, is to increase the expression of stem cells (such as C90 positive cells) in the presence of trauma. In FIG. 2 it is shown that C90+ (Thy1) occur normally in the vascular trees. A and B show normal liver parenchyma in a rodent model. If the tissue is exposed to EPO (250 Units/kg bodyweight) C90+ cell expression is switched on everywhere in the parenchyma within 24-48 hours reaching peak heights of 1 in 5-10 cells being CD90+. It is also shown in FIG. 2 (C) that trauma alone as a pathophysiological condition is not any different from a non-trauma condition with respect to CD 90+, i.e. the parenchyma is free of CD90+ cells. B also shows that this effect is not dependent upon EPO, since in the absence of trauma CD90+ cells are not stimulated to appear. The stimulatory result is rather dependent on a sensory and responsive function of EPO to stimulate the expression of CD 90+ cells in case of trauma (D). This sensory function is shown in FIG. 2 . Only in the conditions accompanied with trauma EPO use leads to the expression of the CD90+ cells. These cells assume a pivotal role in assisting scar free or fibrosis free healing in all injury situations ( FIG. 2 ). [0121] The technology according to the invention carries the possibility to perform a simultaneous recruitment of stem cells by coadministering molecules such as GM-CSF or GSF to increase the availablitiy of MSC from the bone marrow at the sites of need. It is important that these cell recruting activities are done in a timwise identical or overlapping conditions. The topical integration again provides a slow release component and the possibility to use very low concentrations of less than 200 μg/m 2 body surface. [0122] Also in a situation when exogenously obtained stem cells are applied e.g. harvesting from bone marrow or any other site in the body the coadministration of such recruitment factors secures a maintenance of the regenerative signalling not occurring physiologically any more in severely injury conditions. [0123] According to the invention to complete the network of simultaneous interplay and onset of regeneration, the “recruitment factors” are preferably added to increase the number of stem cells both in the peripheral circulation and to exert a topical recruitment of stem cells. The novelty with respect to the invention is its simultaneous timing and role in regeneration in combination with e.g. a scaffold itself (cell free at time of implantation) and alternatively a scaffold inoculated with stem cells at the time of implantation. A third alternative is that no scaffold is used. This is especially advantageous in neuronal diseases including Multiple sclerosis, stroke, Alzheimer, psychiatric diseases and neurodegenerative disorders not responding to a an isolated stimulation of a single factor (e.g. EPO) in a complete and sustainable manner. [0124] FIG. 3 shows a summary of the invention and interaction of contributing components to achieve the maximum healing response. To this purpose the supporting factors may be coated but preferably integrated into (inside) the scaffold materials. This allows that during the remodeling process of the transplanted scaffold a concomitant release to stimulate the advancing cells during the remodeling process is achieved. This means, that a site specific activation process is provided by the local wound environment at the time of transplantation. The human body apparently is able to react to localized trauma by triggering a site specific response that leads to repair. The knowledge for site specific repair must be linked to the combined mode of activity of trauma cytokines and boosting factors. [0125] The process starts by procurement of approximately 100 to 200 ml of peripheral blood (adults, 10-50 ml in children) and centrifugation to obtain the so called buffy coat, containing the CD45+ progenitor cells. Alternatively stem cells can be obtained by aspiration of bone marrow. These stem cells are prepared in a manner to prevent clotting of the aspirate by addition of Heparin or a chelating agents. The cell aspirate may be concentrated or used directly after induction of polymerization and applied to the graft as bio-polymer coating. In this case the blood or plasma components of the stem cell aspirate are induced to clot by addition of Thrombin or Ca++. In addition a collagen based sponge, sponge fragments or collagen powder can be mixed into this preparation to enhance the cohesive and sticky strength of the polymerisation result. Simultaneously this gel like preparation needs to be applied to the surfaces of the scaffold material e.g. a tracheal matrix. In this case the stem cell gel is applied mostly on the external side of the implant. Before that stem cells were incubated with TGF beta3 and erythropoetin. These cells are applied in a circumferential and ring like preparation onto the scaffold. The luminal side and the peripheral site are also pretreated with EPO and TGF beta3 (trachea). The addition of the stem cells in this manner also contributes to achieving a simultaneous enhancement of vascularization of the graft by stem cell activation. The topical application of the diverse factors named, results in rather high topical concentration but very low systemic availability. A systemic application may be followed in a conventional manner. [0126] According to this invention any graft scaffold (e.g. an acellularized or native heart valve or acellular or native trachea) can be initiated as a template to remodel fast. The whole process only require minutes or just 30-45 minutes to prepare. In this sense the material to be remodeled becomes a material that provides the copy—information for the result without being a fully developed graft. [0127] The main advantage of this approach is, that the need for stem cell expansion and predifferentiation before transplantation is abolished completely. In addition the best quality of the implant is achieved as measured by histology and function following remodelling. A further advantage is the site specific mode of action of the commitment factors, that avoid systemic side effects. According to this teaching it is the local presence of permissive factors that together with the exogenously administered boosting factors allow an extremely rapid graft preparation to be done. [0128] Alternatively stem cells can be obtained by aspiration of bone marrow. These stem cells are prepared in a manner to prevent clotting of the aspirate by addition of Heparin or a chelating agents. The cell aspirate may be concentrated or used directly after induction of polymerization and applied to the graft as bio-polymer coating. In this case the blood or plasma components of the stem cell aspirate are induced to clot by addition of, for example, thrombin or Ca++. In addition a collagen based sponge, sponge fragments or collagen powder can be mixed into this preparation to enhance the cohesive and sticky strength of the polymerization result. Simultaneously, this gel like preparation needs to be applied to the surfaces of the scaffold material e.g. a tracheal matrix. In this case the stem cell gel is applied mostly on the external side of the implant. Before that stem cells were incubated with TGF beta3 and erythropoietin. These cells are applied in a circumferential and ring like preparation onto the scaffold. The luminal side and the peripheral site are also pretreated with EPO and TGF beta3 (trachea). The addition of the stem cells in this manner also contributes to achieving a simultaneous enhancement of vascularization of the graft by stem cell activation. The topical application of the diverse factors named, results in rather high topical contraction but very low systemic availability. A systemic application may be followed in a conventional manner. [0129] According to this invention any graft scaffold (e.g. an acellularized or native heart valve or acellular or native trachea) can be initiated as a template to remodel fast. [0130] The following exemplary but not limiting protocol was developed for scaffold remodeling: 1) preparation of the scaffold in a sterile manner 2) Integration of erythropoietin as a sterile powder into the scaffold thickness to achieve depot effects, injection 3) Incubation of mesenchymal stem cells that have been freshly harvested from bone marrow with EPO (250 IU/Kg body weight), time 4) Incubation of peripheral blood mononuclear cells that have been freshly harvested with EPO (250 IU/Kg body weight) 5) Blood derived PBMC inside, bone marrow outside preferably in mixture with local epithelium islands and tissue biopsy fragments from healthy tissue is recommended. 6) Incubation/coating of the scaffold with TGFβ, partyhroid hormone, insulin, dex (alternatively slow release formulation form nano-carriers such as hyaluronic acid) 7) Intraoperative inoculation of these cells in a sterile device for seeding (rotational or coating process). 8) Implantation following ca. 45 min. [0139] FIG. 4 describes graphically the process flow of the method to achieve scar free healing and “restitutio ad integrum” in a patient. A major advantage of the technology is, that if forms the basis for the highest standard achievable to date if compared to the state of the art with respect to sterility, safety, reproducibility, economics, quality of the result and mass applicability. Following procurement of the stem cells under sterile conditions and their preparation all processes are immediately continued directly in parallel to ongoing medical or operative treatment in a patient-side or intraoperative processing. The major advantage comes from the time sequence of events, that avoids extramural processing, leaving the operative theatre, leaving the hospital, cell expansion, complex transport logistics (car, train, airplane and other courier services) and cellular transformation and oncogene activation, cell selections or cloning due to artificial in vitro culture conditions and unwanted manipulations and dedifferentiation of the cells as well as infectious risks. [0140] The handling can immediately done in a clean room situation that benefits from not having to leave the immediate treatment area, which is in all operative situations the operating room being the primary clean room. This offers a number of safety and GMP advantages already. The processing of cells is then done in <<class A>> environment equipped with bioreactors, sterile vessels, sterile ice, holding racks for tubes, sterile cloth covers and presterilized tools. The stem cell concentrate is transferred from the harvesting vessel to inoculate the scaffold that has been prepared in a sterile packaging (e.g. a heart valve scaffold, a collagen sponge). The bioreactors may contain the scaffold already and the respective lyophilisates of the boosting, commitment or recruiting molecules. In a first device the stem cells being provided in a blood or bone marrow or other form of (fat stem cells especially) concentrate are exposed to these factors and stored on ice. In the meantime the scaffold is prepared by injection of the boosting, commitment and/or recruitment factors under the laminar air flow. The bioreactor or device holding the scaffold is placed on a weight measuring instrument to document the weight gains. This instrument is recorded on line using specific software. This software also records the weight gains when in the following step the stem cell concentrate is applied to the scaffold. Inside the hood temperature and air particle concentrations are recorded on line and visualized on a screen next to the hood. The software also documents the time from start of air filtration to the start of the protocol to ensure sterility. As a minimum time is required for clearing the filters the device is switched on appropriately. The person handling the cell processing is using an e.g. foot controllable instrument linked to the server (PC, or avoiding contamination to the hands) to confirm completion of the specific steps to be allowed to advance to the next steps of processing the cells and scaffold. The software thus has a controlling and releasing function besides documentation of the process. This turns the device according to FIG. 10 into an autonomous self-controlled GMP production unit for stem cell processing. The whole process is video recorded from an integrated camera that also feeds the data into the software. This is important for documentation that the processes have been obeyed according to the GMP protocols. Termination of the preparatory process and confirmation by the specific worker doing it permits release of the bioreactor and transport to the operating table. Before transport the bioreactor/device is closed or covered to rule out inlet of contaminants from the air within the operating room (usually class B or C quality). In case a centrifuge is used for the stem cell preparation the centrifuge may be placed outside the production unit if a closed processing is possible. The centrifuge and its manipulative steps are equally recorded by the specific software. After removal of the implant the production unit is cleaned and decontaminated to be prepared for the next patient. Both is equally recorded by the software and confirmed by the worker doing it. All the information collected is transferred either online wherever possible to a centralized registry. In this registry the patient data including diagnosis, disease states and post-treatment course is fed by the doctors/treatment personnel. This assures a complete quality control and accessibility to third party independent quality controls. This approach of intraoperative processing, technology provision and software steering and control permits in association with a third party quality control the world's highest standard of stem cell implant production at the same time while lowering manufacturing cost by a factor of 10-100 over conventional processing. The combination of these process flow advantages represent the key to mass production and mass availability of individualized implants/personalized stem cell based implants. The scientific invention therefore opens the way for a critical industrialization technology that fully complements the scientific, technological and healing advantages of the process and method of this invention. [0141] FIG. 11 summarizes the flow integration for the quality control components according to the invention. The quality control includes the stem cell harvest, stem cell preparation, inoculation steps inside the mobile production unit. All steps are recorded on-line in real-time and independent from manipulative intervention of the worker (doing the stem cell handling) by automatic collection of data. Parameter control precedes the release of the implant. The bioreactor/delivery device is sealed/closed before transferal to the operator. The opening is again documented. The process ends by the documentation of patient conditions. [0142] The device of FIG. 10 is defined as a production unit, that contains the following components in a modular way to function properly according to the invention: A software master controlling all operations and thus forming an operative unit that has sensory, measurement and control functions as well as an overall documentation purpose. The instrumental components of the complete assembly include a laminar air flow conditions of class A, a bioreactor or cell culture device, a video camera, a temperature sensing instrument. While variability exists with respect to the different inoculation of cell culture processing instruments (bioreactors) or petri-dishes the basic advantage of the production unit is its flexibility in this modular design linked to an equally flexible control brain component that lets it function as an autonomous production unit in any operative or treatment environment to achieve custom mass production of individual implants ad hoc in the best quality possible. [0143] In addition and according to the invention an apparatus such as a rotational bioreactor as described previously is used to perform the inoculation procedures in a sterile environment directly inside the operating theatre. The major advantage of the invention comes evident at best, if such apparatuses are used inside a laminar air flow system that provides a class A clean room inoculation cabinet. Bioreactors mounted inside these systems could be run as mobile units inside the operating room just for one patient at a time. In this sense a fully closed production environment is created according to the invention consisting of a mobile laminar air flow system or isolator that contains inside the processing unit, that is brought in contact with the patients cell or blood. These internal devices (bioreactors) are ideally single use (one-way) systems that are positioned on mounting racks that are reusable. It is this combination of a single use device, mobility, class A inoculation and processing and reduced size that allows to use the whole system as a production cabinet intraoperatively for stem cell processing according to the method described above. [0144] According to the invention, EPO is added for example to the stem cell concentrate as solution or as a lyophilisate, preferably as a lyophilisate at a concentration of 150-300, preferably 200-250 Units/kg bodyweight. For topical administration the doses may be higher. [0145] The stem cell concentrate is adjusted in volume to the type of tissue to be regenerated. It is 0.5-1 ml in a topical application, 2-3 ml for a transcutaneous positioning, for example on top of an infracted area in the heart. It can be 10-30 ml for bone regeneration in the mandibula. [0146] This flexibility is achieved by spinning down the complete bone marrow, adipose tissue, blood volume obtained at a speed that allows sedimentation of all cells contained in the original volume. Also a plasma separation (cell free) results. While the very bottom contains a pile up of cells, integration of more volume is always possible with this technique having thus access to an enriched bone marrow concentrate with platelets and red blood cells. Previously, these other components were intended to be discarded. An advantage of this approach is to benefit from the interaction potential of those cells that delivers superior results over the isolated use of e.g. immunologically isolated CD133+ cells, which makes the difference between scar free over scar-like healing. [0147] The topical applicability of G-CSF or GM-CSF in combination with stem cells allows to use a very low concentration if compared to standard systemic applications. In a standard approach 200 μg are coated onto e.g. the scaffold to be remodeled at 10-20 injection sites. EPO can be co-administered simultaneously or shortly before or thereafter by systemic administration. The injection used the stem cell concentrate. For a period of 1-2 weeks thereafter the compounds are injected, e.g. s.c. in the same quantities. [0148] For cartilage regeneration TGFβ is added to these injections into a scaffold of 100-500 ng for a 10 cm 2 patch. [0149] Vitamin C is added especially for neuronal sprouting into a scaffold at 500 μg. Vitamin E is added especially for neuronal differentiation with 30 000 IU. [0150] Viscous gel or hydrogels comprising biological factors or tissue cells are well known in the art. According to the invention preferably polymeric compositions such as polymeric cellulose gels based on, for example, carboxymethyl cellulose can be used to manufacture the respective formulations. DESCRIPTION OF THE FIGURES [0151] FIG. 1 : Expression of EpoR, beta-cR and growth hormone receptor in parallel in tissues and stem cells. [0152] FIG. 2 : This example shows use of the invention to induce the expression of stem cells in the liver parenchyma: A and B represent the non-trauma groups, C and D the trauma groups. The addition of rhEPO generates the expression of CD 90+ cells in the liver parenchyma only in the trauma groups. [0153] FIG. 3 : This summarizes the interplay of the use of recruitment, boosting and commitment factors in the presence of a permissive situation (e.g. trauma). The stem cell preparatory process is accordingly adjusted and can thus be extremely fast requiring only minutes and is done intraoperatively. A template for remodeling is used depending upon size of the defect to be repaired. [0154] FIG. 4 : This example shows a process flow linking the invention to an intraoperative sequence of events being divided in II phases. Phase I is an in vitro phase of cell preparation and stimulation. Phase II includes a stem cell application onto a graft following in situ positioning. E.g, a heart valve can be coated from the peripheral side, reducing risks of manipulative stess and detachment of the cells at the time of implantation. [0155] FIGS. 5 a (top) and b (bottom): This example shows a synthetic graft surface following inoculation with progenitor (stem cells) harvested from the iliac crest and peripheral blood. The cells were mixed into autologous plasma (3 ml). This plasma was brought to polymerization by addition of Thrombin (0.1 units/ml) and applied to the outside of the graft. An advantage of the process according the invention is, that a clot is formed that permits initiating processes like in normal wound healing. Clotting kinetics, clot structure and clot fibrinolysis create a microfiche that if combined with boosting factors, commitment factors and recruitment factors according to the invention is ideal to star a scar free healing process. The graft is created then inside the recipient body within 1-2 weeks. [0156] On the inside (b) the cells were dripped on the luminal surface using a syringe. In b the continuation in vitro using is shown at 14 days. The culture continued under standard conditions. [0157] FIG. 5 c (top) and d (bottom): this example shows a graft prepared according to the invention. It is cut open longitudinally and exhibits a very nice and shiny (non-thrombogenic) lumen. In this large animal model at 4 weeks the controls always (d) clotted. This would be a compete clinical failure. [0158] The fluorescent cells indicate almost 100% viability both luminally and on the outside. The bone marrow/plasma gel represents a 3D nourishing microenvironment that forms a 3D growth zone even if unfavorable conditions would exist initially on the graft materials (see later allogeneic or xenogeneic heart valves that are coated in the same manner). [0159] FIG. 5 e (top) and f (bottom): This figures reiterate the results from a graft implanted at 4 weeks and prepared according to the invention, looking at the histology. In 5 e the graft polymer core is shown with neo-tissue generated towards the luminal and peripheral side. The non seeded graft exhibits a thrombus towards the lumen. In FIG. 5 f the neo-tissue generated is shown surrounding the synthetic core (non-degradable) fiber material. [0160] FIGS. 5 g (top) and h (bottom): FIG. 5 g shows the CD31 (endothelial marker) staining of the luminal side of a graft prepared following the invention. A neo-formation of a vascular endothelium has occurred that prevents the thrombus formation. 5 h shows a biological scaffold demonstrating that reendothelialization from progenitors can occur also using a biological matrix (xenograft) [0161] FIG. 6 : A heart valve is prepared following a decellularization. It is shown that according to the invention a physiology indistinguishable from a normal valve is achieved. Valves are implanted into the aortic position. No failure from the high pressure area has resulted. [0162] FIGS. 7 a and b : FIG. 7 a (top) shows the implantation after a bioreactor culture with stem cells prepared in a plasma gel. The culture in vitro was done for 1 week. This X-ray results correspond to the group D of 7 b (bottom) and show a good progression of bone strengthening over the observation periods of 2, 4 and 6 weeks. On the bottom side ( FIG. 7 b ) picture A is the control defect (critical size defects were established in a pig model), picture B: inoculating tri-calciumphosphate with blood only results in a weak bone trabecle formation, picture C: intraoperative mixture (as done in state of the art, not according to the invention) of the bone replacement material with bone marrow from the recipient, showing a partial progression of healing only. Picture D shows in contrast in this experiment the best result of complete bone regeneration in a critical size model of a bone defect. This proves that the mere use of bone marrow to inoculate the materials is not sufficient to achieve the same progression of regeneration as a standard cell culture with a respective stem cell expansion and ostoblast differentiation would be able to achieve. This inferior quality of the state of art is a conventional form of intraoperative bone marrow use for bone support. As shown in the following figures the advantages of the process and technology according to the invention become clearly evident: [0163] FIGS. 8 a (top, according to state of the art, 6 and 16 weeks after implantation) and b (bottom, example using the invention, 6 weeks after implantation) [0164] FIG. 8 b shows the results of the bioreactor culture (7 day/1 week bioreactor culture) over the controls A: material (TCP+blood) over the intraoperative technology according to the invention combined with EPO. D is a control defect with no filling. All is shown at 6 weeks. It is evident that the intraoperative process (10) according to the invention is now as efficient as a week-long cell culture process. It is also evident from FIG. 8 a that an intraoperative seeding that is being done in a state of the art manner by just adding bone marrow does not lead to an adequate bone formation (a large hole in the bone is still present at 16 weeks, 8 a intraoperative standard technique). 8 b shows thus over 8 a clearly the advantage of a combined process according to the invention, since healing is completed at 6 weeks already in all groups. The standard state of art intraoperative technique of 8 a leaves in contrast a large defect both at 6 but also at 16 weeks ( 8 a ). [0165] In larger defects bone marrow cells prepared according to the invention however will be advantageous over mere blood use. [0166] FIG. 9 a , (top) b (bottom) [0167] This figure shows a patient that has received a stem cell treatment according to the invention with a defect size that is 100 times larger than the critical size defect used in FIG. 8 . The healing progress is rapid (b) and shows a long-term sustainability of the neo-bone with an excellent quality of trabecular bone formation. Normally such an implant would have collapsed (state of the art using stem cell cultures of bone) at 6-8 weeks or would not have remodeled to this type of quality bone at all. Normally the material used remains with little remodeling for many years or is replaced with fibrotic tissue. In the process according to the invention no cell expansion was needed, no scar or fibrosis has resulted and the bone is stable for years. [0168] FIG. 9 c : final result after 1.5 years showing good bone morphology, no collapse but sustainability of the result. [0169] FIG. 10 shows an ideally mobile unit consisting of a one way bioreactor (a closable device) (1) mounted on a docking station or rack (as described previously), a centrifuge (3, may be outside alternatively) and a sterilization device such as UV light. 4 represents the sterile air filtration systems. It is a speciality of this combined device that it represents a miniaturized laboratory inside the operating room. This device can be used to perform cell culture processes that used to take 2-3 weeks in less than 1 hour according to the method of the invention. It is an important feature, that 1 symbolizing any bioreactor for tissue engineering, is ideally an one-way device. The system can move with a closed front window and maintain sterility completely by increasing air pressure inside over ambient air pressure to maintain sterile air flow inside (37° temperature controllable). To this purpose the air is removed outside by 2 uni-directional valves ( 6 a and 6 b ) which are activated when the front window panel ist closed. In addition a monitoring system is included, which fully documents all bioreactor activities (position, temperature, rotations, pumping activity with respect to pressure, speed and volume, open and closed window). The system also measures air particle concentrations inside and causes alarms once the officially required class A thresholds are violated. All these technologies are known individually in the art, but if combined create a significantly increased value and applicability for a mobile stem cell engineered graft production inside of an operative theatre. The device is fully independent and comes with ist own electrical power supply (battery operated). [0170] The system can be sterilized inside with gas or hydrogen peroxide. In addition the system has an antimicrobial surface that contains in one embodiment a silver coating achieved in plasma ionization. [0171] FIG. 11 : Integration of quality control and documentation accompanying and completing the production requirements. EXAMPLES [0172] The following examples describe the invention in more detail. It is emphasized herewith that the choice of cells, factors, conditions, concentrations, methods, scaffolds, formulations etc. indicated in these examples are not limiting the invention and can be replaced, if not otherwise stated, by respective similar, adequate or equivalent, cells, factors, conditions, concentrations, methods, scaffolds, formulations etc., provided that a skilled worker would apply these modifications or alternatives without being inventive. Example 1 [0000] 24 hours before start of operation: erythropoetin sc (normal single dose according to manufacturer recommendation, 10.000 Units) and GM-CSF (normal single dose according to manufacturer recommendation 250 units/m2, 1 vial) to activate stem cell production in the bone marrow and to target autologous stem cells with EPO. Start of anesthesia of the patient with tracheal defect to be repaired Collection of 100 ml blood to obtain autologous plasma (anticoaglulate with low amount of Heparin) Harvest for 30-60 ml of bone marrow aspirate from the patient from the iliac crest Placement of the blood/bone marrow on ice (4° C.) with sterile secondary packaging in heparinized tubes Preparation of operative situs and recovery of additional biopsies with a diameter of 1-2 mm if comparable target tissue is still available. Storage on ice in sterile container in sterile normal saline. Transfer of bone marrow aspirate and tissue biopsies to laminar air flow located ideally directly inside or very close to the operating room Preparation of bone marrow and or blood aspirate or other stem cell source to achieve concentration and/or access of cells. Preparation of stem cells with all but not limited to all possible procedures known in the art including density gradient preparation, immunological separation, concentration, filtration, matrix digestion or mincing and washing. Preparation of injection solutions by aliquoting stem cell concentrates or alternatively plasma and use as solvent for the boosting, commitment and/or recruitment factors. Interim incubation of mesenchymal stem cells that had been freshly harvested from bone marrow with EPO/TGFbeta3 mixture (500 μl)-storage on sterile ice/room temperature (depending upon interval available and progress of parallel operation) and conditioning with those factors in vitro. Injection of specific solutions in regularly distributed different sites into the scaffold for in situ delayed release after implantation and stem cell patterning trough later site specific commitment induction if cells encounter those factors at exactly those predetermined positions. Injections of stem cell, with or without tissue mincing results into appropriate positions (e.g. in the lumen of tubular implants (e.g. valves, vessels, ducts) and intraluminal injection slightly underneath the superficial surface for cell island formation. Transfer to the operative site and implantation Coating of the stem cell mixture to the wall with autologous plasma or fibrin glue intraoperatively to allow gentle positioning and to avoid removal during implant handling. Implantation following 45 min Postoperative treatment of patient with boosting and/or recruitment factor until end of simulated wound healing phase (often 2 weeks, longer if necessary e.g. in spinal injury). Example 2 Cardiovascular Engineering [0188] In an experimental design six allogeneic and 4 xenogeneic valves were harvested in a sheep model of aortic valve replacement. 2 of the valves underwent an decellularizaton process using a detergent (chenodesocycholic acid) as known in the art. These valve were then stored at 4° and brought to the operative theatre in sterile condition. The valves were injected with Erythropoetin (5.000 units) and G-CSF (Leukine, Sargramostim) and Growth hormone luminally with a very small syringe diameter (0.5 mm) to reduce damage. Simulataneously bone marrow was harvested with a total volume of 30 ml. The bone marrow was spun down at 1500×g for 7 minutes. The centrifugation was done with heparinized blood. 1 cc of the remaining pellet was injected underneath the superficial matrix of the luminal side resulting in a patchy distribution of the stem cells. This served the purpose of protecting the cells from detachment after introduction into the blood stream. Following implantation the valves were coated with 5 ml of bone marrow concentrate that was prepared. Example 3 Synthetic Graft Experimental Procedure [0189] In this case a synthetic graft is used. Such grafts may be PTFE, polyester grafts, combined polyester with silicone grafts, collagen tubes, collagen—elastin grafts, biological grafts with or without decellularization. An induction of the polymerization process of the stem cell coating is achieved by adding a polymerization agent such as Thrombin (0.1 units/ml) or Ca++ antagonizing the clotting preventing agents used during the bone marrow or blood collection. The clotting kinetics lead as to a triggering effect for the subsequent healing process, clot structure and clot fibrinolysis create a microniche that if combined with boosting factors, commitment factors and recruitment factors according to the invention is ideal to provide a scar free healing process. Cells do not grow into holes or empty spaces. The gel obtained from the clotting process is preferably an artificially shaped polymer to achieve a specific geometry. The entrapment of cells is advantageous for establishing communication pathways between stem cells, platelets, fibers, red blood cells, white blood cells and all the entrapped stem cells including CD90, CD133, CD106, and CD45. [0190] The graft is created then inside the recipient body within 1-2 weeks. The slow release mechanisms lead to a controlled interaction of the graft coating with the cells starting the remodeling process from within. The process continues until cytokine stimulation derived from the wound area and the entrapped inflammatory cells is finished in parallel (simultaneously) to the healing results. It was found that IL-6, IL-1 and TNF are important trauma cytokines activating the stem cells (permissive factors). The polymerization process and the entrapment of the immunocompetent cells is supportive for the completion of the interaction cascade (according to FIG. 3 of the invention). Even on heterogenous of synthetic surfaces the neo-graft is formed with a fully biological luminal and peripheral side. The differentiated cells include fibroblasts, smooth muscle cells, endothelial cells (CD31+). The technology provides a significantly better potential of applicability as the thrombogenicity is reduced greatly. A hyperplasia has not occurred. An important application therefore is the treatment of endoluminal (cardio)vascular stents, which mostly fail due to hyperplasia especially end zones. A neoformation of a vascular endothelium occurs that prevents the thrombus formation. The scaffold may be decellularized with a trypsin based approach or using a detergent (e.g. chenodesoxycholic acid). [0191] The following protocol can be used: Intraoperative process for synthetic implant individualization using a polyester, collagen, chitosan, polyester+silicone coated graft, or e.g. but not limited to a PTFE graft 24 hours before start of operation: erythropoietin sc (normal single dose according to manufacturer recommendation, 10.000 Units) and GM-CSF (normal single dose according to manufacturer recommendation, 1 vial) to activate stem cell production in the bone marrow and to target autologous stem cells with EPO. Start of anesthesia of the patient with graft defect to be repaired Collection of 50 ml blood to obtain autologous plasma (anticoaglulate with low amount of Heparin) Harvest for 30 ml of bone marrow aspirate from the patient from the iliac crest Placement of these 30 ml on ice with sterile secondary packaging in heparinized tubes Preparation of tracheal situs and recovery of 5 bronchial epithelial biopsies with a diameter of 1-2 mm and storage on ice in sterile container in sterile normal saline Transfer of bone marrow aspirate and epithelial biopsies to laminar air flow cabinet for further processing. Centrifugation of bone marrow aspirate for 7 min at 4° C. to achieve concentration of cells Separation of plasma from stem cell concentrate by transfer to a sterile tube on ice Preparation of erythropoietin solution using 1 ml of the plasma supernatant obtained from the centrifugation process (50.000 units, Neorecormone, Roche) Addition of TGF beta 3 sterile to the EPO-plasma solution locally specific. Incubation of mesenchymal stem cells that have been freshly harvested from bone marrow with EPO/TGFbeta3 mixture (500 μl)-storage on sterile ice Injection of EPO/TGF solution in 10 different sites of the tracheal scaffold for in situ delayed release after implantation. Incubation of 1 ml stem cell, epithelial cell mixture in the lumen of the tracheal scaffold, and intraluminal injection for cell island formation Transfer to the operative site and implantation Coating of the stem cell mixture to the wall with autologous plasma or fibrin glue intraoperatively to allow gentle positioning and to avoid removal during implant handling. Implantation following 45 min Example 4 Valve Engineering [0209] A major current tissue engineering limitations in the use of decelluarized tissues especially is the lack of stability and pressure resistance that complicates the use of such valves in a high pressure environment. Also the postulated growth in a pediatric environment was judged to be a dilatative response rather than true growth. These problems are resolved with the following protocol. Alternatively decellularized vessels or valves are equally quickly primed to perform fast remodeling in vivo. The process according to the invention can thus improve also decellularized matrices. [0210] Valve Protocol: Intraoperative Process for Allogeneic Valvular Implant Individualization 24 hours before start of operation: erythropoietin sc (normal single dose according to manufacturer recommendation, 10.000 Units) and GM-CSF (normal single dose according to manufacturer recommendation, 1 vial) to activate stem cell production in the bone marrow and to target autologous stem cells with EPO. Start of anesthesia of the patient with heart valve defect to be repaired Collection of 200 ml blood to obtain autologous plasma (anticoaglulate with low amount of Heparin) and buffy coat. Harvest for 10 ml of bone marrow aspirate from the patient from the iliac crest Placement of these 10 ml on ice with sterile secondary packaging in heparinized tubes Preparation of valve situs and recovery of 5 valvular biopsies with a diameter of 1-2 mm and storage on ice in sterile container in sterile normal saline Transfer of bone marrow aspirate and epithelial biopsies to laminar air flow bench for further processing. Centrifugation of bone marrow aspirate for 5 min at 4° C. to achieve concentration of cells Separation of plasma from stem cell concentrate by transfer to a sterile tube on sterile ice Preparation of erythropoietin solution using 1 ml of the plasma supernatant obtained from the centrifugation process (50.000 units, Neorecormone, Roche) Addition of HGF and/or VEGF to the EPO-plasma solution Incubation of mesenchymal stem cells that have been freshly harvested from bone marrow with EPO storage on sterile ice Injection of EPO/HGF solution in 10 different sites of the tracheal scaffold for in situ delayed release after implantation. Incubation of 1 ml stem cell, endothelial/stem cell mixture in the lumen of the tracheal scaffold, and intraluminal injection for cell island formation, Use of unexpanded but freshly prepared cells Luminally buffy coat derived cells are seeded. Transfer to the operative site and implantation Coating of the stem cell mixture to the wall with autologous plasma or fibrin glue intraoperatively to allow gentle positioning and to avoid removal during implant handling. Implantation following 45 min Example 5 Airway Engineering [0228] “Trachea Protocol”: intraoperative process for allogeneic tracheal implant individualization” 24 hours before start of operation: erythropoietin sc (normal single dose according to manufacturer recommendation, 10.000 Units) and GM-CSF (normal single dose according to manufacturer recommendation, 1 vial) to activate stem cell production in the bone marrow and to target autologous stem cells with EPO. Start of anesthesia of the patient with tracheal defect to be repaired Collection of 50 ml blood to obtain autologous plasma (anticoaglulate with low amount of Heparin) Harvest for 10 cee of bone marrow aspirate from the patient from the iliac crest Placement of these 10 cc on ice with sterile secondary packaging in heparinized tubes Preparation of treacheal situs and recovery of 5 bronchial epithelial biopsies with a diameter of 1-2 mm and storage on ice in sterile container in sterile normal saline Transfer of bone marrow aspirate and epithelial biopsies to laminar air flow laboratory for further processing (cryolab). Centrifugation of bone marrow aspirate for 5 min at 4° C. to achieve concentration of cells Separation of plasma from stem cell concentrate by transfer to a sterile tube on sterile ice Preparation of erythropoietin solution using 1 ml of the plasma supernatant obtained from the centrifugation process (50 000 units, Neorecormone, Roche) Addition of TGF beta 3 sterile to the EPO-plasma solution Incubation of mesenchymal stem cells that have been freshly harvested from bone marrow with EPO/TGFbeta3 mixture (500 μl)-storage on sterile ice Injection of EPO/TGFβ solution in 10 different sites of the tracheal scaffold for in situ delayed release after implantation. Incubation of 1 cc stem cell, epithelial cell mixture in the lumen of the tracheal scaffold, and intraluminal injection for cell island formation Transfer to the operative site and implantation Coating of the stem cell mixture to the wall with autologous plasma or fibrin glue intraoperatively to allow gentle positioning and to avoid removal during implant handling. Implantation following 45 min. Example 6 Liver Engineering [0000] 24 hours before start of operation: erythropoetin sc (normal single dose according to manufacturer recommendation, 10.000 Units) and GM-CSF (normal single dose according to manufacturer recommendation, 1 vial) to activate stem cell production in the bone marrow and to target autologous stem cells with EPO. Start of anesthesia of the patient with liver defect to be repaired. This includes typically patients with chronic cyrrhosis, acute on chronic liver failure, extensive liver resections including live organ donations and liver organ transplantation. Collection of 200 ml blood to obtain platelet rich plasma (anticoaglulate with low amount of Heparin) and or PBMC, or a concentrate of all of it (combined for better effects and ease of preparation) Harvest for 100 ml of bone marrow aspirate from the patient from the iliac crest Placement of these 100 ml on ice with sterile secondary packaging in heparinized tubes Simultaneous to an endoscopic operation and preparation of liver situs and recovery of 5 liver fragment biopsies with a diameter of 1-2 mm (obtained at a liver resection from an edge of the liver) and storage on 4° C. ice in sterile container in sterile normal saline Transfer of bone marrow aspirate and liver biopsies to laminar air flow bench for further processing. Centrifugation of bone marrow aspirate for 5 min at 4° C. to achieve concentration of cells Separation of plasma from stem cell concentrate by transfer to a sterile tube on sterile ice Preparation of erythropoietin solution using 1 ml of the plasma supernatant obtained from the centrifugation process (10 000 units, Neorecormone, Roche) Addition of HGF to the EPO-plasma solution Incubation of mesenchymal stem cells that have been freshly harvested from bone marrow with EPO storage on sterile ice Injection of EPO/G-CSF/HGF solution in 10 different sites of a collagen sponge scaffold for in situ delayed release after implantation. Incubation of a final 5 ml stem cell concentrate, liver tissue fragments/stem cell mixture onto the surface of the scaffold. Polymerization is achieved by adding thrombin. Transfer to the operative site and implantation, attachment to the liver by gluing on top of a resected surface or on top of a cirrhotic liver. 10-20 small micropunctures on the surfaces to achieve blood access continuity with the sponge are done. Coating of the stem cell mixture to the wall with autologous plasma or fibrin glue intraoperatively to allow gentle positioning and to avoid removal during implant handling. Implantation following 30 min Example 7 Skin Engineering [0261] Protocol for decubitus, diabetic ulcer, ischemic legs, infected wounds in any area. at start of operation: erythropoietin sc (normal single dose according to manufacturer recommendation, 10.000 Units) and GM-CSF (200 μg/m2 for a 70 kg patient/low dose) to activate stem cell production in the bone marrow and to target autologous stem cells with EPO. As the condition is often not comparable in severity GM-CSF or G-CSF may be omitted. Start of anesthesia of the patient Collection of 200 ml blood to obtain platelet rich plasma (anticoagulate with low amount of Heparin) and or PBMC, or a concentrate of all of it (combined for better effects and ease of preparation) Collection of 30-60 ml of bone marrow aspirate from the patient from the iliac crest Placement of the collection results on ice with sterile secondary packaging in heparinized tubes Surgical debridement of infected wounds. Removal of necrotic tissue as normal. Especially in burns or if granulation tissue is present in chronic wounds, a preparation of 10 skin biopsies with a diameter of 1-2 mm (obtained from healthy areas) serves the purpose to support the epithelialization. Specimens are stored on 4° C. ice in sterile container in sterile normal saline or autologous plasma Transfer of bone marrow aspirate and skin biopsies to laminar air flow bench for further processing. Centrifugation of bone marrow aspirate at 4° C. to achieve concentration of cells Separation of plasma from stem cell concentrate by transfer to a sterile tube on sterile ice Preparation of erythropoietin solution using 1 ml of the plasma supernatant obtained from the centrifugation process (10 000 units, Neorecormone, Roche) Addition of to the EPO-plasma solution Incubation of mesenchymal stem cells that have been freshly harvested from bone marrow with EPO storage on sterile ice Injection of EPO/G-CSF solution in 10 different sites of a collagen sponge scaffold for in situ delayed release after implantation. Alternatively mixture with the stem cell concentrate and induction of polymerization. Incubation of a final 5 ml stem cell concentrate, skin tissue fragments/stem cell mixture onto the surface of the scaffold. Polymerization is achieved by adding thrombin. If no scaffold is available the bone-marrow concentrate is brought to polymerization of a plastic surface (e.g. Petri dish, bioreactor). This forms a gel like a membrane, that can be transferred after gelling to cover the wound. Transfer to the operative site and implantation, positioning to the wound (Transplantation following 30 min) Alternatively or in addition the cell/factor mix is injected into the wound edges (5 ml total at 10 different sites). Cover with a collagen sponge and complete cover of the are with a transparent film Example 8 Cardiac Engineering [0280] Protocol cardiac ischemia, heart attack, cardiomyopathy. The goal is to position a stem cell gel according to the invention underneath the pericardial sac via a transcutaneous way at start of operation, or even when patient is available after diagnosis of acute cardiac attack. EPO 10000 Units and/G-CSF is given as an acute medication at 250 Units/kg bodyweight, G-CSF at 250 μg/patient of 70 kg. In not so severe cases EPO alone is sufficient. Collection of 200 ml blood to obtain platelet rich plasma (anticoaglulate with low amount of Heparin) and or PBMC, or a concentrate of all of it (combined for better effects and ease of preparation) Collection of 30-60 ml of bone marrow aspirate from the patient from the iliac crest, in local anesthesia Placement of the collection results on ice with sterile secondary packaging in heparinized tubes Start of local anesthesia of the patient at the chest. Positioning of a catheter through the chest under x-ray control to reach the pericardium and positioning of the opening underneath the pericardium on top of the infracted area. Transfer of bone marrow aspirate to laminar air flow bench for further processing. Centrifugation of bone marrow aspirate at 4° C. to achieve concentration of cells Preparation of erythropoietin, G-CSF solution using 1 ml stem cell concentrate obtained from the centrifugation process (10.000 units, Neorecormone, Roche), storage on sterile ice. Addition of the highly conserved serum response factor (SRF) and myogenin may be done to support cardiac muscle differentiation. Induction of polymerization and injection via the catheter on top of infracted area. closure of pericardium time needed: 10-20 min Example 9 Cornea Engineering [0294] The repair of the cornea especially when no healthy controlateral eye with intact limbal stem cells is available is not possible. In a conventional approach stem cells would need to be expanded as well. Other eye applications include macula degeneration, blindness, optical neuritis, dry eye. A deeper injection may be chosen for macula degeneration. According to the invention a threefold rapid process can be done: A) direct stimulation during acute injury after washing with the boosting factor EPO applied as a lyophilisate mixed with artificial lacrimae B) preparation of a corneal biopsy from the controlateral eye, mincing to achieve very small specimens, or gentle digestion to obtain isolated cells and washing. Incubation of the cell specimens with EPO and positioning on top of the eye. Alternatively cells may be injected underneath or into the damaged cornea. The cornea may be removed surgically in some areas. In very severe cases GCSF is given sc together with EPO until wound healing has completed (1-2 weeks) C) if no corneal biopsy is available at all stem cells obtained from PBMC or bone marrow concentrate are added to artificial lacrimae or plasma and positioned together with EPO and/GCSF onto or into the damaged cornea. Example 10 Breast Reconstruction or Breast Implant [0298] The repair of the breast is achieved by series of injections with a stem cell gel according to the inventions to build up missing tissue after resections. It is also used to prepare the surface of a breast implant to avoid scar and fibrosis formation. As commitment factors sexual hormones are used to trigger the maturation of the stem cells into the breast tissue lineage. According to the invention a two-threefold rapid process can be done: A) direct stimulation of the implant the boosting factor EPO applied as a lyophilisate mixed stem cell concentrate B) Preparation of a breast biopsy from the controlateral breast, mincing to achieve very small specimens, or gentle digestion to obtain isolated cells and washing. Incubation of the cell specimens with EPO and injection with stem cell concentrate. Alternatively cells may be injected in repetitive procedures to achieve build up. GCSF is given sc together with EPO until wound healing has completed (1-2 weeks). Hormones used include estrogen, FSH (follicle stimulating hormone), growth hormone, progesterone and prolactine. Example 11 Spinal Cord Regeneration or Peripheral Nerve Regeneration [0301] The regeneration of neurons is achieved by positioning a stem cell gel either on top of the ischemic area after decompression or by replacement using a collagen guide as a tube. With this stem cell gel according to the inventions the regeneration of missing neuronal tissue is possible. It is also used to prepare the implant to avoid scar and fibrosis formation. As commitment factors nerve growth factor is used, in combination with vitamin C (or alone for sprouting) and Vitamin D (for neuronal differentiation) to trigger the maturation of the stem cells into the neuronal lineage. [0302] According to the invention a twofold rapid process can be done: A) direct stimulation of the wounded nerve tissue using the boosting factor EPO applied as a lyophilisate mixed stem cell concentrate B) Injections of GCSF, EPO, Vitamin C and Vitamin D se over a period of up to 4-6 weeks if no surgical access is possible C) Interposition as a stem cell gel with the above factors induction of polymerisation. To enhance stability of the gel a collagen powder is mixed into the polymerising bone marrow stem cell concentrate with the factors. Example 12 Tendon, Ligament, Intervertebral Disc, Meniscus, Cartilage Regeneration [0306] The regeneration such connective tissue is achieved by positioning a stem cell gel either on top of the injured area or by injection into the injured area. To obtain material for the commitment minced original tissue is obtained from the disrupted or damaged areas (often from trauma). In a degenerative situation wound cytokines are generated by artificial puncturing with a needle to support the stem cell gel/factor mix according the invention. In the case of an intervertebral disc TGF beta is applied in addition to support the reformation of the nucleus pulposes. If fragments are available they are mixed together into the stem cell gel. [0307] With this stem cell gel according to the inventions the regeneration avoiding scar and fibrosis formation is possible. As commitment factor fibroblast growth factor can be added for acceleration to achieve rapid results. [0308] According to the invention a threefold rapid process can be done: direct stimulation of the wounded tissue using the boosting factor EPO applied as a lyophilisate mixed stem cell concentrate Injections of GCSF, EPO, over a period of up to 1-2 weeks if no surgical access is possible (especially as a preventive measure) Injection of a stem cell gel with the above factors induction of polymerization. To enhance stability of the gel a collagen powder is mixed into the polymerizing bone marrow stem cell concentrate with the factors. [0311] In the case of cartilage regeneration a scaffold/gel prepared of chitosan is used and inoculated with the stem cell/factor gel including TGF beta (20 ng) at the time of implantation. Fixing of the gel/is achieved by gluing to the inured surface. Ideally a chitosan gel or fibrinogen gel may be used. [0312] During the healing phase supporting s.c of the factors (EPO, GCSF) can be used. TGF may be reapplied as well. Example 12 Sphincter Engineering [0313] Sphincters are repaired intraooperatively in a manner comparable to the cardiac engineering. The stem cell/factor gel is injected into the remaining sphincter tissue. In addition a ring of neo-tissue can be formed surrounding the old sphincter. Remodeling occurs in 2 weeks. Example 13 Venous Valve Engineering [0314] For regeneration of venous valves a stem cell collagen sponge including EPO and/or GCSF is wrapped around the vein intraoperatively. It has a length of 2-3 cm and can be sutured to approximate the insufficient valve. FGF may be used in addition but is not always needed. Example 14 Vertebral Bone Engineering [0315] The stem cell gel is injected into the collapsed vertebra after repositioning it back to its original size. The gel polymerizes inside. It may be mixed with collagen powders and any form of bone replacement material. A supportive commitment factor is vitamin D. The use of BMP or derivatives is not need but a co-application with the other factor and the stem cell process is possible.

Methods, technical apparatus and compositions to achieve short term processing for the manufacture of a graft or a transplant in the form of a scaffold that can be used to treat or to heal injuries and traumas of a great diversity of tissues and organs in a central or peripheral location of the human or an animal body. Tissue regeneration by way of stem cells and different specific tissue and organ repair promoting factors that activate the endogenous or exogenous stem cells to differentiate to specific tissue cells thus reconstituting the original microenvironment of the cell damaged by the injury.

This is a continuation of application Ser. No. 530,349, filed May 30, 1990, now abandoned. FIELD OF THE INVENTION The present invention is concerned with cosmetic and body preparations containing non-leachable and non-absorbable anti-microbial polymers. More particularly, the invention relates to cosmetic and body preparation which contain anti-microbial polymers comprising polymers having carboxyl groups which are wholly or partially neutralized or exchanged with quaternary ammonium cations or polyamines possessing anti-microbial activity. BACKGROUND OF THE INVENTION There is a need in the cosmetic industry to provide a means for preventing fungal and/or bacterial growth in cosmetic and other body preparation which has no adverse effects on the user. There is a further need to provide body preparations which will inhibit the growth of odor causing bacteria and fungus. It is known that extended wear of fingernail coatings can lead to fungal growth which can effect the wearer. However, there has not been found any effective means for combatting the fungal growth in a fingernail polish composition which does not yield another health hazard to the user. It is further known that cosmetic compositions, such as lipstick and eye make-up provide a good environment for bacterial growth which is aided by its method of application. Prior to the present invention there has not been any means for combatting bacteria which is safe and effective and also compatible with cosmetic formulations. Previously, hexachlorophene was widely used in many cosmetic and body preparations to kill bacteria on contact and to prevent growth of bacteria and fungus. Hexachlorophene was included in deodorant compositions, talcum preparations, foot powders, lipsticks, and the like. However, the hexachlorophene was used in direct contact with skin and was absorbable. Prolonged exposure to hexachlorophene was considered as being hazardous so that it was withdrawn from use in such compositions. The bacteriostatic agents which are presently being utilized by the cosmetic industry such as 3-(trifluoromethyl)-4, 4'-dichlorocarbanilide (IRGASAN) and 5-chloro-2-(2,4-dichlorophenoxy) phenol (IRGASAN DP-300) of Ciba-Geigy cannot be utilized in hyperallergenic cosmetic formulations since there is the possibility of irritation over extended use. The compounds while insoluble in water are soluble in alkaline solutions and in organic solvents so that the compounds can be leached out of the composition. Moreover, these compounds have no film forming capabilities so that they cannot be effectively utilized in nail polishes and the like without adverse effects on the film forming properties of the compositions. Additionally, bacteriostatic agents merely prevent the growth of existing organisms and do not kill on contact new microorganisms which may be introduced into the compositions. There is a need to provide hyperallergenic cosmetic compositions with a means for preventing bacterial and fungal growth which does not adversely affect the user. Japanese Patent Publication No. 1989-22824, discloses a medicament for external use that is fungicidal and exhibits an antibacterial spectrum. The medicament comprises quaternary ammonium salts of polymeric carboxylic acid compounds which are sparingly soluble in water. However, the active component is utilized for its ability to permeate into the cutaneous stratum corneum so that such use cannot be continuous and without medical supervision. The polymeric medicaments disclosed in the Japanese publication can be used in the present invention through the modification of the polymers with a suitable crosslinking agent as now proposed which insolubilizes the polymer-quaternary ammonium compound in the environment utilized but still provides the kill on contact of the microorganisms. U.S. Pat. No. 4,332,763 to Hempel et al discloses the use of a quaternary ammonium polymer obtained by the reaction of dimethyl sulphate with a mixed polymer of vinyl pyrrolidone and dimethylamino ethylmethacrylate. However, the quaternary ammonium cation of this polymer is leachable and the polymer is slightly soluble so that polymer cannot be used in cosmetic compositions. U.S. Pat. No. 3,872,128 to Byck, which is herein incorporated by reference, discloses anti-microbial ammonium polymer salts which are prepared from carboxyl-containing α-olefin polymers and quaternary ammonium salts. The polymers are used to form polymeric articles for hospitals and patient care. U.S. Pat. No. 3,404,134 to Rees, which is herein incorporated by reference discloses a process for crosslinking copolymers of alpha olefin and alpha, beta ethylenically unsaturated carboxylic acid units. The copolymers are crosslinked utilizing diamine cations. None of the diamine cations are stated as being anti-microbial. Furthermore, the polymers are used to make molded articles and sheet material. U.S. Pat. Nos. 3,488,215 and 3,865,619, which are herein incorporated by reference, disclose swollen or swellable hydrophilic resins that can be crosslinked with select quaternary ammonium salts and used in the present invention. It is understood that the term "polymer-quat" as used herein means polymers which are wholly or partially neutralized with biocidally active quaternary ammonium compounds or polyamine such as by ionic bonding or crosslinking whereby the biocidal activity of the quaternary ammonium compound or amine is maintained. The term "body composition or preparation" used herein relates to powders, lotions, salves, or the like used in treating the body such as food powders, talcum preparations, deodorant preparations, baby preparations and the like. SUMMARY OF THE INVENTION In accordance with the present invention there is provided a means for destroying and/or inhibiting the growth of microorganisms in cosmetic and body preparations by incorporating therein an effective amount of a non-leachable non-absorbable anti-microbial polymer containing carboxyl groups which are at least partially neutralized or exchanged with anti-microbial quaternary ammonium cations or polyamines. Advantageously, the anti-microbial polymer is crosslinked to adjust its solubility according to the compositions in which it is used. The crosslinking can be reversible or irreversible so that the polymer can be solubilized or insolubilized before or after formulation. The polymer-quats can be used directly in existing cosmetic compositions, baby lotions, hand creams and the like as potential fungicides, bactericides, and in general, anti-microbials. The killing power or attenuation power is dependent upon the particular anti-microbial quaternary ammonium compound or amine compound which is utilized. The solubility of these polymer-quats in aqueous and organic solvents can be modified by the addition of crosslinking agents, for example ammonium, sodium, magnesium, calcium or aluminum cations, or the use of diquaternary compounds. The amount of crosslinking will affect the solubility of the polymer-quats. The nature of the quaternary amine cation, the extent of neutralization and the amount of quaternary amine cation per polymer chain, and the nature of the comonomer with the carboxyl containing group will affect the solubility of the polymer-quats. Therefore, these factors can be adjusted so that the polymer-quat is soluble only in the aqueous phase of a cream or cosmetic, or is soluble only in the organic phase or in both phases. In addition, the nature of the polymer-quat can be adjusted to lie on the surface of the skin without penetration or causing irritation. DESCRIPTION OF THE PREFERRED EMBODIMENTS In accordance with one embodiment of the invention the anti-microbial polymer-quats are formed in a continuous phase, that is, solubilized or at least swollen either in water, an organic phase or a mixed organic and water phase by the reaction of a biocidal quaternary ammonium salt with a carboxyl-containing polymer. After formation of the polymer-quat, the solubility of the polymer-quat is adjusted with suitable crosslinking agents prior to formulation into the cosmetic or body composition, after formulation or upon contact with the skin. In some cases there is no need for adjustment because the solubility is proper for the formulation and contemplated use. These polymer-quats are unique in that they are formed from polymers which are initially solubilized or totally swollen by the solvent. They can then be tailored in their solubility to be soluble or insoluble in different phases of the formulations. These polymer-quats can be reversibly or irreversibly crosslinked to modify there reactivity and solubility in various applications. Hydrophilic polymer-quats that can be swollen are disclosed in U.S. Pat. No. 3,865,619. These polymer-quats comprise: (a) about 12 to 30 percent by weight of an ethylenically unsaturated polymerizable monomer having a salt forming or salt group therein; (b) about 40 to 88 percent by weight of at least one alkanol ester of acrylic acid and/or methacrylic acid, said esters having from 1-4 carbon atoms in the alcohol portion thereof. The monomers of Part (a) having salt groups can either be salts of polymerizable carboxylic acid, salts of polymerizable amines, or quaternary ammonium salts. Preferred materials include the salts of α, β-unsaturated aliphatic mono- and di-carboxylic acids, particularly salts of those acids having 3-5 carbon atoms, such as salts of acrylic acid, methacrylic acid, maleic acid, fumaric acid, and itaconic acid. Salts of half-esters of the aforementioned dicarboxylic acids, particularly of esters formed with C 1-8 alkanols, as well as salts of vinyl sulfonic acids or of methacryl taurines are suitable. Salts of acrylic acid and methacrylic acid are preferred. As cations for solubilizing the polymers, those of the alkali metals are preferred, as well as those of the alkaline earth metals, of amines such as trimethylamine, tributylamine, mono-, di-, and tri-ethanolamine, and diethylamine, or of ammonium and alkyl-ammonium. In accordance with a second embodiment of the invention the anti-microbial polymer-quats of the invention are prepared with a water soluble polymer, namely one which has been neutralized with sodium ions and treated with an anti-microbial quaternary amine salt. The sodium salt is then washed from the gelled or less soluble polymer-quaternary salt complex which separates. Alternatively, the complex may be formed by reacting a quaternary amine acetate with the free carboxyl groups of the polymer and removing the acetic acid which is formed. The solubility of the polymer-quats of the invention can be adjusted by utilizing suitable quaternary ammonium salt reactants, crosslinking with diquaternary ammonium compounds; suitable polyamines, alkali or alkaline earth cations, or the like. Some of these crosslinking techniques are discussed in the aforementioned patents. The copolymers which may be used in preparing the polymer-quats of the second embodiment of the present invention comprise at least one alpha olefin unit having the general formula: ##STR1## wherein R, R' and R" each represent a radical selected from the class consisting of hydrogen and hydrocarbyl radicals having one to eight carbon atoms and at least one alpha, beta ethylenically unsaturated carboxylic acid unit having one to two carboxylic acid groups, and X represents --OR, COOR, CN or phenyl. Preferably, the alpha, beta ethylenically unsaturated carboxylic acid unit has 3 to 8 carbon atoms. Specific alpha olefin units useful in the copolymers include: ethylene, propylene, butene-1, styrene, pentene-1, hexene-1, heptene-1, 3 methylbutene-1, styrene, pentene-1, hexene-1, and heptene-1. Units useful in the copolymers include: acrylic, methacrylic, ethacrylic, itaconic, maleic, fumaric, monoesters of dicarboxylic acid such as ethyl hydrogen fumarate, maleic anhydride, ethyl hydrogen maleate, vinyl alcohol, vinyl chloride, vinyl acetate and vinyl ethers. Maleic anhydride and other alpha, beta ethylenically unsaturated anhydrides are considered acids for the purposes of the present invention. Additionally, any third copolymerizable monomer can be employed in combination with the olefin and the carboxylic acid comonomer. Preferred termonomers are vinyl esters are acrylates, i.e., alkyl acrylates and methacrylates having up to eight carbon atoms, such as vinyl acetate, vinyl propinate, methyl methacrylate and ethyl acrylate. The scope of base copolymers suitable for use in the present invention is illustrated by the following examples which include high and low molecular weight polymers: Ethylene/acrylic acid copolymers, ethylene/methacrylic acid copolymers, ethylene/itaconic acid copolymers, ethylene/methyl hydrogen maleate copolymers, ethylene/maleic acid copolymers, ethylene/acrylic acid/methyl methacrylate copolymers, ethylene/methacrylic acid/methyl methacrylate copolymers, ethylene/itaconic acid/methyl methacrylate copolymers, ethylene/methyl hydrogen maleate/ethyl acrylate copolymers, ethylene/methacrylic acid/vinyl acetate copolymers, ethylene/acrylic acid/vinyl alcohol copolymers, ethylene/propylene acrylic acid copolymers, ethylene/styrene acrylic acid copolymers, ethylene/methacrylic acid/acrylonitrile copolymers, ethylene/fumaric acid/vinyl methyl ether copolymers, ethylene/vinyl chloride/acrylic acid copolymers, ethylene/vinylidene chloride/acrylic acid copolymers, ethylene/vinyl fluoride/methacrylic acid copolymers, ethylene/chlorotrifluoroethylene/methacrylic acid copolymers, ethylene/methacrylic acid/acrylic acid copolymers, ethylene/maleic acid or anhydride copolymers, and ethylene/methacrylic acid/maleic anhydride copolymers. Other suitable polymers include carboxyl cellulose, low molecular weight styrene/maleic acid or anhydride copolymers, polyacrylic acid, polymethacrylic acid, copolymers of vinyl ether and maleic anhydride, condensation acids from oleic acid, linoleic acid, and the like. The cations used in adjusting the solubility of the polymer can be supplied as water soluble salts. The cations should have an effective valence of one to three. The term "effective valence" as used herein means that the cation forming material is readily ionized to form cations having a valence in the range of one to three, but that the cation forming material is not readily ionized to form cations having more than three valence charges; in other words, the cation is complexed to such an extent that the number of ionic charges is in every case in the range of 1 to 3. The preferred complexed metal ions are those in which all but one of the metal valences are complexed and one is readily ionized. Such compounds are in particular the mixed salts of very weak acids, such as oleic and stearic acid, with ionizable acids, such as formic and acetic acid. The uncomplexed metal ions which are suitable for use in the process of the present invention comprise mono-, di- and trivalent ions of metals in Groups I, II, III, IV-A and VIII of the Periodic Table of Elements (see page 392, Handbook of Chemistry and Physics, Chemical Rubber Publishing Co., 37th ed.). Uncomplexed monovalent metal ions of the metals in the stated groups are also suitable in forming the ionic copolymers of the present invention with copolymers of olefins and ethylenically unsaturated, dicarboxylic acids. Suitable monovalent metal ions are Na + , K + , Li + , Cs + , Ag + , Hg + , and Cu + . Suitable divalent metal ions are Be +2 , Mg +2 , Ca +2 , Sr +2 , Ba +2 , Cu +2 , Cd +2 , Hg +2 , Sn +2 , Pb +2 , Fe +2 , Co +2 , Ni +2 , and Zn +2 . Suitable trivalent metal ions are Al +3 , SC +3 , Fe +3 , and Y +3 . The complexed metal ions which are suitable for use in the process of the present invention are di, tri, tetra and hexavalent ions that have been complexed so that their effective valence is within the range of 1 to 3, preferably 1. Suitable metal ions are the divalent and trivalent ions listed above, tetravalent ions such as Ti +4 , Zr +4 , Hf +4 , V +4 , Ta +4 , W +4 and hexavalent ions such as Cr +6 , Ce +6 , and Fe +6 . Suitable complexing agents include stearate, oleate, salicylate, and phenolate radicals. The metallic cations can be added to the copolymer in the form of salts, oxides, hydroxide, carbonate, free metal, metal hydride, metal alkoxide or organometallic compounds. If the metallic cation producing material is readily soluble in water at the reaction conditions, a considerable degree of reaction between metallic ions and the carboxyl groups will take place. The equilibrium of the reaction can be shifted to favor this reaction by removal of the anionic portion of the cation producing material as soon as it has become associated with the acid hydrogen. If the cation producing material is the salt of a very weak acid such as sodium resorcinol, the equilibrium of the reaction is sufficiently in favor of the formation of the ion links, and no steps need to be taken to remove the anionic portion of the cation producing material from the copolymer. If the new salt of the cation is less soluble, the reaction will shift in favor of the new polymeric salt. If the metallic cation producing material is substantially insoluble under the reaction conditions, it is desirable to convert the insoluble material into a soluble or slightly soluble one in situ to accelerate the reaction. This may be readily accomplished in the case of metal oxides, hydroxides and carbonates by the addition of acid such as acetic acid, lactic acid, propionic acid, and mixtures of these acids. Some of the factors which cause "diaper rash" or "diaper dermatitis" include ammonia, bacteria, pH, candida albicans and moisture. Urine in contact with enzymes and bacteria breaks down into ammonia and causes odor. It therefore appears that diaper rash control may be achieved to some degree by eliminating or reducing the bacteria and enzymes which are present and those which promote the breakdown of urine. Accordingly, it is proposed to include in body preparations and powders which are intended for use infants and individuals suffering from incontinence the polymer-quats of the invention in order to reduce and control the growth of the bacteria and enzymes which may be present. A suitable body powder for infants and for adults to control odor comprises 20 to 40 parts by weight of talc, about 20 to 40 parts by weight of a buffer, preferably sodium bicarbonate, about 10 to 20 parts by weight of polymer-quat and optionally, perfume. Representative examples of suitable quaternary nitrogen-based anti-microbial agents include methylbenezalkonium chloride, benzalkonium chloride, dodecyltrimethyl ammonium bromide, tetradecyltrimethyl ammonium bromide and hexadecyltrimethyl ammonium bromide. Heterocyclic quaternary nitrogen-based anti-microbial agents include dodecylpyridinium chloride, tetradecylpyridinium chloride, cetylpyridinium chloride (CPC), N-alkyl pentamethyl propane diammonium dichloride, dicocodimethyl ammonium chloride, pyridinium salts, pyridinium salts, triazines such as DOWICIL sold by Dow Corning Corporation, tetradecyl-4-ethylpyridinium chloride and tetradecyl-4-methylpyridinium chloride. Other suitable anti-microbial agents which may be used are disclosed in Kirk-Othmer; Encyclopedia of Chemical Technology, 3rd Ed. Vol. 7, 1979, pp 793-832. In accordance with a still further embodiment of the invention, there is provided a film forming anti-microbial polymer which can be incorporated into existing cosmetic setting lotions and lacquers, such as, for example, nail polish. In some cases, the polymer-quat of the invention can be used in place of a polymer of the composition. Typical nail polish formulation in which the polymer-quat can be incorporated are disclosed in U.S. Pat. Nos. 4,289,752; 4,032,628 and 3,925,287, which are herein incorporated by reference. Generally, an amount of about 0.5 to 5% by weight of solids in the composition is sufficient to prevent growth of fungi. The polymer-quats of the invention can be generally prepared as follows: A solution of the polymer in water or water-alcohol is formed either as the ammonium or sodium salt with ammonium or sodium hydroxide, respectively. The anti-microbial compound is dissolved in water or a water soluble solvent if possible. The molecular ratio of anti-microbial compound to sodium or ammonium carboxylate groups in the polymer or mixture of polymers is adjusted to one or less than one by varying the quantity of solution to be added to the polymer solution. The appropriate amounts of the two solutions are mixed with stirring forming a fine precipitate. After about an hour the precipitate is filtered off and dried. This polymer quat is used for adding directly into skin lotions, cosmetics, herbicides, etc. for control and the killing of microorganisms to increase the shelf life of the cosmetics. If the solubility of the polymer-quat is too high, it can be adjusted or modified by the addition of di-or polyquaternary ammonium salts which serves to crosslink the polymer chains causing the polymer-quat to be more insoluble. The addition of polyvalent cations such as calcium, magnesium, aluminum, etc. will also cause the polymer chains to associate or crosslink and become more insoluble. The addition of polyamines also will cause this reversible crosslinking. The preparation of the polymer-quats generally follow the following reactions: yQ.sup.+ X.sup.- +POLYMER(COO.sup.- M.sup.+).sub.y →POLYMER(CO.sup.- Q.sup.+).sub.y +M.sup.+ X.sup.- 1) wherein M=Na, ammonium, K, Li, etc. X=Cl, acetate, Br, etc. y=1 or more, preferably 1-2 Q=a quaternary compound or polyamine yQ'+POLYMER(COOH).sub.y →POLYMER(COO.sup.- H.sup.+ Q).sub.y 2) yH.sup.+ Q.sup.- "+POLYMER(COO.sup.- HN.sup.+ RR'--NR'R").sub.y →POLYMER(COO.sup.-HN.sup.+ RR'--NRR'H.sup.+ Q) 3) yH.sup.+ Q.sup.- "+POLYMER(NRR').sub.y →POLYMER(NRR'H.sup.+ Q.sup.-).sub.y 4) wherein R, R' and R"=hydrogen, alkyl, alkenyl, etc. Conventional high shear grinding procedures can be used to form the pigment containing cosmetic preparations with the polymer-quats of the invention. Typical procedures that are used are sand grinding, ball milling, pebble milling, attritor grinding, high shear mixing and the like. For pigments which are difficult to disperse, a two roll mill technique is used. Typical pigments of this type are iron oxide pigments, irgazin yellows, and the like. In a typical two-roll mill process, is mixture is prepared from the pigment and a solution of the polymer-quat and charged onto a two roll mill in which one roll is heated to 75°-150° C. and the other is about room temperature. The mixture is milled until a uniform dispersion is formed. This can be blended with other cosmetic ingredients to form a mill base. The following examples are illustrative of the invention but are not to be construed as to limiting the scope thereof in any manner. The percentages disclosed herein relate to percentages by weight unless otherwise stated. EXAMPLE 1 A. Preparation of copolymer: ______________________________________Ingredients % by weight______________________________________Methyl methacrylate 40Styrene 10N-butylacrylate 16Methacrylic acid 34______________________________________ The ingredients are mixed in 120 parts of ethanol and 280 parts of dioxane using 1.5 parts of tert.butyl peroctate. B. The polymer solution of Part A is then neutralized with a 1 percent solution of sodium hydroxide and filtered. The white filtrate is then stirred in an aqueous solution of 10% dimethyldidecylammonium chloride for two hours. The resulting mixture is cooled and filtered to yield a powder of swollen methylmethacrylate n-butylacrylate/styrene ionically bonded and swollen with the dimethyldidecy ammonium compound. C. Test An antibacterial spectrum was measured in the following manner. To a 500 ml-Erlenmeyer flask which was placed in a constant temperature bath of 30° C. equipped with a shaker was added 20 mg. of polymer-quat of Part B. To the flask was added 100 ml of bacteria suspension listed in Table 1 (6×10 8 cells of bacteria) of 30° C. and the mixture was shaked immediately. Each 1 ml. of the mixture was sampled 0, 2 and 5 minutes after the addition of the bacteria suspension. The sample was immediately diluted with sterile isotonic sodium chloride solution in 10, 100 and 100 times in dilution rate and then spread on nutrient agar plates. Survival rate (%) was determined by measuring the survived bacteria in the colony after cultivation at 37° C. for 24 hours. The results are given in Table 1. TABLE 1______________________________________ Survival rate (%)Bacteria after 2 min. after 5 min.______________________________________Staphylococcus aureus 0 0(ATCC6538)Salmonella choleraesius 0 0(ATCC10708)Brevibacterium ammoigenes 0 0(ATCC6871)Proteus Vulgaris 30.5 5(ATCC8427)______________________________________ EXAMPLE 2 An aqueous solution of didecyl dimethyl ammonium chloride was added slowly with stirring to an aqueous solution of sodium carboxymethyl cellulose. The molecular amount of anti-microbial was approximately 0.8 ratio to the amount of neutralized carboxyl groups present in the polymer. The resultant slurry was stirred for one hour and filtered and the recovered solid dried. The solid polymer-quat was used directly in formulations as an anti-microbial compound. EXAMPLE 3 A solution of Adogen 477 (a diquaternary chloride) namely, N-fallow pentamethyl propane diammonium dichloride in water was added to an aqueous solution of low molecular weight polyacrylic acid (as the ammonium salt) with vigorous stirring. The molecular amount of anti-microbial was approximately 0.8 ratio to the amount of neutralized carboxyl groups present in the polymer. The precipitate was filtered and dried. It was useful as a anti-microbial formulating agent. EXAMPLE 4 A solution of low molecular weight copolymer of ethylene/acrylic acid as the ammonium salt was added to a solution of BIOBAN P-1487 which is a mixture of substituted morpholines having as the principal ingredient 4-(2-nitrobutylmorpholine). About 4% of a 5% solution of calcium chloride was then added to ensure total precipitation and insolubilization of the polymer-quat. The molecular amount of anti-microbial was approximately 0.8 ratio to the amount of neutralized carboxyl-groups present in the polymer. The precipitate was recovered and used as an anti-microbial agent in formulations. EXAMPLE 5 ______________________________________MAKE-UP FOUNDATIONIngredient % by weight______________________________________Polymer-quat of Example 2 5.0Isopropyl lanolate 4.0Stearic Acid 2.6Self-emulsifiable glycol stearate 5.0Cosmetic oil 20.0Sodium lauryl sulfate 1.1Bentonite 2.5Perfume qsDemineralized water qs 100Additives:Titanium oxide qs according to shadesIron oxide and coveringTalc powder desired______________________________________ EXAMPLE 6 ______________________________________BODY POWDER OR BABY POWDERIngredient % by weight______________________________________Talc 40Sodium bicarbonate 40Polymer-quat of Example 3 20______________________________________ As a body powder the composition is effective to deactivate or kill odor causing bacteria. As a baby powder the sodium bicarbonate neutralizes the pH of urine and the polymer-quat kills the odor causing bacteria in the urine. EXAMPLE 7 A nail polish is prepared according to the invention by mixing the following ingredients. A. Base Varnish ______________________________________Ingredient % by weight______________________________________Nitrocellulose 14Camphor 2Butyl phthalate 5Ethyl alcohol 4Butyl alcohol 4Toluene 20Ethyl acetate 15Butyl acetate 32Carboxy cellulose - didecyldimethyl 4Ammonium polymer-quat______________________________________ The polymer-quat can be replaced by any other film forming polymer-quat of the invention. B. The base varnish can be used to obtain a polish for coloring nails by admixing thereto certain dyes and an antisediment mixture: ______________________________________Antisediment mixture______________________________________Bentone 1.20 gPhosphoric 0.02 gDyes:Titanium oxide 1 gD and C Red 7 0.4 gD and C Red 11 0.3 gD and C Red 5 0.2 gD and C Yellow 5 0.6 g______________________________________

A cosmetic or body composition containing an effective amount of a non-leachable anti-microbial polymer. The polymer contains carboxyl groups which are at least partially neutralized or exchanged with anti-microbial quaternary ammonium cations or anti-microbial polyamides.

BACKGROUND OF THE INVENTION RELATED APPLICATIONS This application is a continuation-in-part of copending patent application Ser. No. 825,672, filed Aug. 18, 1977, now abandoned. FIELD OF THE INVENTION This invention relates generally to the field of packages for matches, and more particularly concerns safety packages adapted to prevent children from inadvertently striking cardboard matches thereon. DESCRIPTION OF THE PRIOR ART The potential disasters engendered when young childern, particularly in the age group of one to four years old, play with matches are well known and feared by parents. Heretofore, however, there has not been developed a package for cardboard matches which is designed to defeat a young child's efforts to produce a flame by striking a match from a package which he has come across in his interminable searching and wandering. The only pertinent prior art of which applicant is aware is the well-known matchbook comprising a deck of cardboard matches attached to a base along a perforated line, and a cardboard cover is folded so as to provide a back portion, an upturned lip, and front flap. The base of the match deck is interposed between the lip and back portion and secured there with a staple extending through the lip, base and back. The front flap portion is openable and closable by tucking its free end between the lip and the match deck base. In most such matchbooks, a striking strip is provided on the front, presented surface of the lip portion of the cover. The striking strip is comprised of a layer of an appropriately abrasive material affixed to the cardboard cover material, which generally has a non-abrasive, decorative finish. The striking strip is usually in a contrasting color to the remainder of the cover--usually the strip is a very dark brown--and is completely accessable. The only "safety features" provided with such matchbooks are the fact that the cardboard matches contained therein may only be struck on the provided striking strip, and the familiar legend printed on the match cover, "Please close cover before striking". The accessability and noticeability of the match striking strip, together with the ease with which the cover may be opened and the matches obtained, make such matchbooks hazardous in the hands of inquisitive children. After having seen an adult open the cover, pull out a match and draw the colorful head of the match across the dark, abrasive strip to produce a flame, a curious child will find it relatively easy to emulate those actions when given the opportunity to pick up such a book of matches carelessly left lying about. The potential danger goes without saying. It is an object of the invention herein disclosed to provide means for striking matches which are not easily used by young children, and which require more than casual observance of an adult utilizing the striking means in order for a child to successfully strike a match himself. It is a further object of the invention to combine the striking means with a standard matchbook to produce an improved, safe matchbook, which is also an inexpensive-to-produce article of manufacture. SUMMARY OF THE INVENTION In accordance with the present invention, the abrasive, match-striking strip is provided with a cover flap extending longitudinally thereof. By this arrangement, a two-fold safety factor is accomplished. First, the dark colored, abrasive strip is hidden from the view of a child either observing an adult's use of the invention, or playing with it himself: he cannot see what it was that the adult struck his match on, and consequently, will have difficulty striking a match himself. Second, the striking strip, being covered, is not easily accessable to a child's random poking and prodding with an unspent match, and, therefore, accidental striking of a match is much less likely than with the common matchbook presently in use. The only way a match can be struck with the present article of manufacture is by placing the unspent match end in the recess formed between the safety flap and the striking strip--a deliberate action which is likely to be beyond the dexterity of a large number of small children. By constructing the inventive article so that the material used and the transverse dimensions of the match-covering cavity bounded by the walls of the protective "tube" are such that insufficient friction can be generated by simply placing a match head in contact with the striking strip and moving it back and forth, another safety feature is achieved. To strike a match placed in such a cavity, the match head must be pinched between the striking strip and the inside surface of the safety flap with one hand as it is drawn out of the cavity with the other. This pinching action is carried out rapidly and is virtually unnoticeable to a child observing it, thus, not only will a child have trouble emulating the action, the limits of his dexterity and strength will also deter him from efficiently copying the requisite motion. Finally, the "tubular" striking means can be easily and cheaply manufactured simply by extending the upturned lip portion of the presently known matchbooks, and making several easy folds in the extension material to define a safety flap. The matchbook is completed by a staple extending through the lip, match deck base, and back portion of the cover. The vastly improved safety cover herein disclosed can be manufactured with little or no change in the presently used method of manufacture. It will be appreciated that an effective safety package for matches has been disclosed which hinders a child's observation of the method of striking matches, prevents accidental striking of a match randomly contacted with the package, and which requires that several deliberate steps be taken before a match may be struck, which steps are beyond the ability of most young children to perform due to limits on their strength and dexterity. These and other features of the invention will be discussed in more detail in the following sections. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view in perspective, indicating the proper use of a matchbook constructed in accordance with the present invention; FIG. 2 is a view in perspective of the article of manufacture of the present invention, with the safety flap folded back so as to reveal the striking strip; FIG. 3 is a view in end elevation of a matchbook constructed in accordance with the present invention as it appears with safety flap flattened against striking strip; FIG. 4 is a view similar to that shown in FIG. 3 of the match cover with safety flap spaced apart from striking strip. FIG. 5 is a view in perspective of another embodiment of the invention, showing the safety flap in its unfolded state. FIG. 6 is a view similar to that shown in FIG. 5 with the safety flap partially folded. FIG. 7 is a view similar to that shown in FIGS. 5 and 6 with the safety flap folded and in its normal, flattened position. FIG. 8 is a view in perspective showing the operation of the invention. FIG. 9 is an enlarged sectional view of the invention as seen from the line 9--9 of FIG. 7 showing its normal position in solid lines, and indicating its second, use position in dotted lines. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to FIG. 2, there is shown an improved, safe matchbook 10, constructed in accordance with the present invention. As in conventionally known matchbooks, matchbook 10 comprises a cardboard cover 12, enclosing a plurality of cardboard matches 14 (shown in FIGS. 3 and 4) which are perforatedly attached to one or two cardboard base members 16. Cover 12 includes a back portion 18, a front flap 20, and an upturned lip portion 22. Affixed or coded, on the front presented surface of lip portion 22 is a match-striking strip 24. Striking strip 24 may be of sandpaper or emery paper, or some other suitable abrasive material which is well-known in the art. As opposed to the rough texture of strip 24, the remaining surfaces of cover 12 are generally smooth, and often polished and printed with decorative material, so that a match may only be struck on strip 24. On a conventional matchbook, lip 22 terminates at the edge indicated by fold line 26, and front cover flap 20 is tucked between lip 22 and the base or bases 16 to secure the flap in a closed position. In the present invention, a safety flap 28 extends from lip 22, as shown in FIG. 2. Safety flap 28 is folded down along fold line 26 and secured to lip portion 22 by means of staple 30 which extends through flap 28, lip 22, base or bases 16 and back 18. By folding flap 28 over and securing it to lip portion 22, a generally tubular structure is achieved, whereby striking strip 24 is situated within a longitudinally extending, match-receiving cavity 32, which is open at both ends to facilitate insertion of a match 34 therein, as indicated in FIG. 1. It will be appreciated that flap 28 could be secured to lip 22 by means other than a staple--glue, for instance, would be appropriate--or that a continuous tubular wall-something on the order of that provided by a soda straw--having a striking portion on the interior wall would be within the scope of my invention. However, the preferred form, especially for the purpose of ease of manufacture, is the flap and staple arrangement shown in the drawings. Cavity 32 extends, in longitudinal dimension, over the length of striking strip 24. In its transverse dimensions, cavity 32 must be such that, when a match is inserted therein, with its head resting against striking strip 24, there will be no appreciable force exerted by the interior wall of flap 28 tending to press match head 36 against strip 24. In general, this means that cavity 32 is slightly larger in transverse dimension than the corresponding dimensions of the matchhead portion 36 of match 34. This dimensioning allows match 34 to be easily inserted into cavity 32; it also ensures that there is not such a tight fit of the match between the interior wall of flap 28 and striking strip 24 that sufficient striking friction can be generated by simply pulling the match out of the match receiving space. Since cardboard matches are not very rigid in their construction, there is also no way to "lever" matchhead 36 against strip 24 by applying a moment around the shaft portion of match 34 while it is inserted in space 32--such a moment would only buckle the shaft of match 34. Consequently, the only way in which sufficient striking friction can be generated is to insert match 34 into cavity 32, and pinch matchhead 36 between flap 28 and strip 24 as it is drawn out of cavity 32. This operation is illustrated in FIG. 1. As there suggested, the requisite striking action requires use of both hands, and a level of dexterity, coordination, and timing, which, although simple for adults to master, is beyond the capabilities of most children in the age group which is the target of the invention. To accomplish the pinching of the matchhead, safety flap 28 is flattenable against lip 22, and strip 24 and illustrated in FIGS. 3 and 4. This is primarily due to the generally non-rigid characteristic of the cardboard used in the construction of cover 12. This "flattenability" could be accomplished by other means with other materials, however--by scoring, hinging, spring-biasing, etc. Referring to FIGS. 5-9 a second embodiment of the present invention is shown. The matchbook 10' of this embodiment includes a cardboard cover 12' enclosing a comb of matches 14', having a base member 16'. Cover 12' comprises a back cover portion 18' attached to a front cover portion 20' by means of a hinge portion 21', which not only allows front cover 20' to be opened, but also provides for a sliding motion of front cover 20' between the first and second position shown in FIG. 9. An upturned lip 22' curls around base member 16', and a staple 30' extends through lip 22', base 16' and back cover 18' to secure the match comb 14' within cover 12'. Cover 12' further comprises a safety flap portion 40' extending from lip 22' above the staple point. Safety flap 40' is folded along fold lines 42', 44' and 46' as shown in FIGS. 5, 6 and 7 in a "reverse-S" manner to define panels 48' and 50', and second upturned lip 52'. Striking strip 24' may be mounted on the interior surface of panel 48', as shown in FIG. 5, or on the interior surface of panel 50' (not shown). Upturned lip 52' and panel 50' cooperate to define a receiving groove for front cover 20', as is best shown in FIGS. 7-9. Safety flap 40', when folded, is normally in the flat position shown in FIG. 7, whereby there is no access to striking strip 24'. A sliding movement of front cover 20', as shown in FIG. 8 to a second position, bulges panel 50' outwardly to define a generally tubular member, thus giving access to striking strip 24'. This sliding action is best shown in FIGS. 8 and 9. With panel 48' bulged outwardly, a match 34' may be inserted in the longitudinal, flattenable cavity defined by panels 48' and 50', and struck as previously described. It will be appreciated that the addition of a safety flap over the striking strip of a conventional matchbook--an inexpensive operation requiring no additional parts and very few modifications in the present method of manufacture-- provides several extremely beneficial safety factors. First, the striking surface of the match cover and the entire striking operation are effectively hidden from the casual observance of a young child watching an adult strike a match. Second, the striking strip is covered so that a child who picks up the book cannot accidentally strike a match on an easily accessable, exposed surface of the book. Third, the presence of the open ended tube formed by the safety flap in the lip portion requires that a match be held between thumb and forefinger and inserted longitudinally therein in order for the match head to be brought into contact with the striking strip; this step requires manual dexterity and hand-eye coordination that very young children may not have developed, thus precluding their being able to strike a match on the safety package. Finally, the dimensions of the tube formed by the safety flap--particularly the transversely measured distance between the interior surface of the safety flap and the striking surface are such that a match head once inserted into the tube, must be pinched between the flap and striking strip by exerting a force on the outside surface of the flap with the fingers of one hand, while drawing the match rapidly across the strip and from the tube with the other hand--an easily disguised motion which a child may not learn by casual observance, and a difficult-to-perform step for a young child with limited strength and dexterity. All of their safety features previously described are present in this embodiment of the invention. In addition, a further step of bulging the safety flap by sliding the cover is required, so as to further hamper a child's attemp to strike a match, and, also, if safety flap 40' should for some reason be torn from the matchbook 10', the striking strip 24' will also be removed, thus rendering the remaining assembly strike proof.

An improved package for matches is disclosed, in which the striking surface of the package is protected by a flattenable, generally tubular enclosure. The enclosure hides the striking surface from view, and prevents a match from being struck unless it is pinched between the striking surface and the interior wall of the enclosure as it is drawn across the striking surface. The tubular enclosure may include a front cover receiving recess, and normally be in a flattened position, whereby a sliding motion of the front cover towards the tubular enclosure while in engagement with the receiving recess expands the tubular enclosure allowing access to the striking surface.

CROSS REFERENCES TO RELATED APPLICATIONS The present application is a continuation-in-part of U.S. application Ser. No. 10/015,526, filed Dec. 13, 2001. FIELD OF THE INVENTION The present invention relates to golf balls which exhibit the ability to correct their flight path during flight. More particularly, the present invention relates to golf balls of improved construction having a controlled weight distribution about a designated spin axis. The weight distribution imparts stable spin characteristics to the golf ball and corrects side spin caused when the ball is not squarely hit. The present invention is also directed to a method for producing a golf ball having a controlled weight distribution about a designated spin axis. BACKGROUND OF THE INVENTION Generally, there are at least three different types of golf balls that are currently commercially available. These are one-piece balls, multi-piece solid balls having two or more solid pieces or components, and wound balls. The one-piece ball typically is formed from a solid mass of moldable material which has been cured to develop the necessary degree of hardness. The one-piece ball possesses no significant difference in composition between the interior and exterior of the ball. These balls do not have an enclosing cover. They are utilized frequently as range balls or practice balls. One piece balls are described, for example, in U.S. Pat. Nos. 3,313,545; 3,373,123; and 3,384,612. Conventional multi-piece solid golf balls, on the other hand, include a solid resilient center or core comprising a single or multiple layer of similar or different types of materials. The core is enclosed with a single or multi-layer covering of protective material. The one-piece golf ball and the solid core for a multi-piece solid (non-wound) ball frequently are formed from a combination of materials such as polybutadiene and other rubbers cross-linked with zinc diacrylate (ZDA) or zinc dimethacrylate (ZDMA), and optionally containing fillers and curing agents. The cores are molded under high pressure and temperature to provide a ball of suitable hardness and resilience. For multi-piece non-wound golf balls, the cover typically contains a substantial quantity of thermoplastic or thermoset materials that impart toughness and cut resistance to the covers while also providing good playability and distance characteristics. Examples of suitable cover materials include ionomer resins, polyurethanes, polyisoprenes, and nylons, among others. The wound ball is frequently referred to as a “three-piece” ball since it is produced by winding vulcanized rubber thread under tension around a solid or semi-solid center to form a wound core. The wound core is thereafter enclosed in a single or multi-layer covering of tough protective material. For many years the wound ball satisfied the standards of the U.S.G.A. and was desired by many skilled, low handicap golfers. The three piece wound ball typically has a cover comprising balata, ionomer or polyurethane like materials, which is relatively soft and flexible. Upon impact, it compresses against the surface of the club producing high spin. Consequently, the soft and flexible covers along with wound cores provide an experienced golfer with the ability to apply a spin to control the ball in flight in order to produce a draw or a fade, or a backspin which causes the ball to “bite” or stop abruptly on contact with the green. Moreover, the cover produces a soft “feel” to the low handicap player. Such playability properties of workability, feel, etc., are particularly important in short iron play and at low swing speeds and are exploited significantly by highly skilled players. However, a three-piece wound ball has several disadvantages. For example, a soft wound (three-piece) ball is not well suited for use by the less skilled and/or medium to high handicap golfer who cannot intentionally control the spin of the ball. In this regard, the unintentional application of side spin by a less skilled golfer produces hooking or slicing. The side spin reduces the golfer's control over the ball as well as reduces travel distance. Consequently, the impact of an unintentional side spin often produces the addition of unwanted strokes to the golfer's game. The above described golf balls have been developed and designed by various golf ball manufacturers to be generally uniform in consistency. In essence, the different layers are designed to be relatively uniform in composition and the covers or centers are essentially centered in the middle of the ball. The center of gravity (“COG”) of these commercial balls is very desirably at the center point of the ball. Unlike the conventional balls briefly described above, the balls of the present invention are not uniform in consistency. The balls of this invention have been specifically designed to produce a controlled weight distribution about a designated spin axis. It has been found that this selectively controlled weight distribution imparts a spin stabilization effect about the ball's spin axis. Such a selected weight distribution also corrects the undesired side spin that is produced when the ball is incorrectly struck or mishit with a golf club. In this regard, when a ball is properly struck, the ball will rise in flight towards the intended direction of travel. This is due to the transformation of forces from the club to the ball and the lift produced by the ball which is back spinning in the air. After being properly struck, the ball will spin about an axis horizontal to the ground (“horizontal axis”) such that the bottom of the ball moves in the direction of flight and the top moves opposite to the direction of travel. This results in the ball back spinning in the air in the direction of travel about an axis of rotation or spin axis. As the ball spins (i.e. backspins) in flight, the ball lifts into the air. The addition of dimples or surface depressions in the ball surface further increases the lifting forces by creating localized areas of turbulence. However, when a ball is improperly struck (i.e. the club face is not traveling in the same direction that it is desired for the ball to take), a side spin is also imparted on the ball. When this occurs, the ball is forced to one side or another of a desired flight path resulting in a curved flight known as “hook” or “slice.” Such a curved flight pattern is generally undesirable by the average golfer. Accordingly, the present invention is directed to improved golf ball components and golf balls employing the same, which have a weight distribution that produces a preferred spin axis. The preferred spin axis is perpendicular to a gyroscopic center plane and corrects side spin imparted by striking the ball with an open or closed club face. These and other objects and features of the invention will be apparent from the following summary of the invention, description of the preferred embodiments, the drawings and from the claims. SUMMARY OF THE INVENTION One of the objects of the present invention is to provide a self-correcting golf ball which reduces the hooks and slices produced when the ball is mis-hit. The golf ball has the ability to correct its flight path by re-orienting itself along a central axis during flight. More particularly, the present invention is directed to a golf ball comprising at least one high-density region centered about the spin or rotational axis of the ball. The region is positioned in the ball along the ball's gyroscopic center plane. The center plane is perpendicular to the desired or designated spin or rotational axis of the ball. In this regard, it is rare during play that a golf ball exhibits pure backspin (rotation about a horizontal axis in flight) or pure sidespin (rotation about a vertical axis in flight). Instead, the actual spin of a ball during flight is a combination of these spin characteristics. Consequently, during flight, a golf ball will typically spin about a tilted axis that is oriented at some angle. In the present invention, the ball produces a stabilized spin in flight, even if mishit. By utilizing a controlled weight distribution, the ball will reorient its spin pattern in flight. As described in greater detail herein, the present invention preferably features a multi-layer golf ball construction comprising at least a core, mantle, and cover layer. A core is utilized which features a body having a recess or recessed channel extending about its outer periphery along a common plane. During formation of the golf ball, the channel is filled with composite mantle material having a specific gravity which is preferably greater than that of the core. In certain even more preferred embodiments, the channel has particular dimensions. The channel can vary in depth and width to maximize the self-correcting function and durability features of the ball. The mantle is further encapsulated by an outer cover layer. Additionally, the ball of the invention can be optionally designed to exhibit enhanced distance. Specifically, the C.O.R. of the ball can be increased by the removal of excess weighting material compounded into the core and repositioning the removed weight by alternative materials at a distance radially outward from the core. In a further aspect, the present invention provides a golf ball exhibiting controlled spin characteristics. The golf ball comprises a generally spherical core component in which the core defines a recess or recessed channel extending about the outer circumference of the core along a common plane. The recessed channel defined in the core component has a depth of from about 0.050 inches to about 0.300 inches, preferably of from about 0.040 inches to about 0.250 inches, most preferably from about 0.030 inches to about 0.200 inches. The golf ball also comprises a mantle layer disposed on and uniformly encapsulating the core. The mantle layer extends into the channel and has a greater specific gravity than that of the core. This forms, in part, a weighted, longitudinal band extending about the core. The golf ball further comprises a cover disposed on and about the mantle layer. The cover has an outer surface and defines a plurality of dimples along the outer surface. In yet another aspect, the present invention provides a self-correcting golf ball exhibiting improved spin characteristics. The golf ball comprises a generally spherical core component in which the core defines a recess or recessed channel extending about its outer periphery along a common plane. The channel is aligned with, and forms, the ball's gyroscopic center plane and is centered about the ball's spin axis. The recessed channel defined in the core component has a width of from about 0.100 inches to about 0.500 inches, more preferably from about 0.100 inches to about 0.250 inches and most preferably from about 0.100 inches to about 0.200 inches. The golf ball further comprises a mantle layer disposed on and encapsulating the core. The mantle layer extends into and fills the recessed channel and has a specific gravity that is greater than that of the core. In such an embodiment, lighter cores are utilized and heavy weight filler materials are included in the mantle compositions. The golf ball further comprises a cover disposed on the mantle layer to form a solid, non-wound golf ball. The cover has an outer surface and defines a plurality of dimples along the outer surface. The weighted channel formed within the core of the golf ball of this embodiment assists in the orientation of the core during ball flight. As the ball finds the central axis, it will correct its flight path. In a still further aspect, the present invention provides a golf ball exhibiting improved spin characteristics. The golf ball comprises a generally spherical core component. The core defines a recessed channel extending about an outer periphery and along the circumference of the core along a common plane. The recessed channel can be formed by removing (such as by cutting, ablation, and so forth) material from a molded spherical core or by being shaped or formed during the molding process using an appropriately shaped mold. For example, the core can be molded in a cavity that has been formed to make the channel aligned with or perpendicular to the core equator. Use of a cavity that has been formed to make a channel perpendicular to the core equator avoids core removal difficulties, etc., produced by molding the channel at the equator of the core. The golf ball further comprises a mantle layer disposed on and encapsulating the core. The mantle layer extends into and fills the channel of the core and is preferably comprised of a composite material having a higher specific gravity than the core. As a result, the channel is positioned in the core about the ball's spin axis in such a manner to produce a gyroscopic center plane. The specific gravity of the mantle layer is from about 0.60 to about 8.0, more preferably from about 0.85 to about 7.0, and most preferably about 0.90 to about 6.0 or more than the specific gravity of the core component. The golf ball further comprises a cover molded about the mantle and core assembly. The cover has an outer surface and defines a plurality of dimples along the outer surface. The golf ball of this embodiment of the invention corrects for side spin, which is often unintentionally imparted to the ball when the ball is struck with the club face either open (which causes slicing of a conventional golf ball) or closed (which causes hooking of a conventional golf ball). This is because the ball of the present invention will revert to the stable, gyroscopic spin axis during spin decay. More particularly, when the ball of this embodiment of the invention is first struck by a club head, the ball will spin about various axes caused by deviations in the center of gravity, the geometrical center of the ball, etc. However, shortly thereafter, due to the positioning of the high-density materials in the gyroscopic center plane, the ball will spin backwards about a steadying axis, thereby reducing side spin. In yet another aspect, the present invention provides a self-correcting, multi-piece golf ball that features a core with a molded-in, recessed channel. Composite mantle materials of different specific gravities are utilized to produce a golf ball having the ability to correct its flight path by reorienting itself along a central axis during flight. The golf ball comprises a generally spherical core component with a molded-in, recessed channel extending about its outer periphery and along its circumference along a common plane. The core component may consist of one or more layers. The golf ball also comprises a mantle layer disposed on and encapsulating the core. The mantle layer extends into the recessed channel of the core. The golf ball further comprises a cover disposed on the mantle layer. The cover may comprise of one or more layers. The cover has an outer surface and defines a plurality of dimples along the outer surface. The specific gravity of the core component can be greater or lesser than the specific gravity of the mantle layer. This is dependent upon the degree of ball correction desired and the other characteristics and/or features of the finished ball. In a further aspect, the present invention provides a method of forming a multi-layer golf ball having improved spin characteristics. The method comprises a step of providing a material suitable for forming a golf ball core. The method also includes a step of forming a core from that material such that the core provides a recessed, equatorial or longitudinal channel extending about an outer periphery and along the circumference of the core along a common plane. The method additionally includes a step of forming a mantle layer on the core such that a portion of the mantle layer is disposed within the recessed channel. The core and mantle layers differ in specific gravity in an amount sufficient enough to cause the weighted channel to reorient the ball in flight. The method also includes a step of forming a cover layer on the mantle layer. This method produces a golf ball having stabilization gyroscopic characteristics. That is, regardless of the initial orientation of the ball prior to striking with a club, once struck, the axis of rotation of the ball will change until the axis is perpendicular to the common plane of the channel. This gyroscopic characteristic is beneficial in that it stabilizes the spinning ball and greatly reduces the tendency for the ball to hook or slice. It may be desirable for putting purposes to stamp an arrow on the outside of the golf ball indicating the location of the internal weighted band. When putting, the ball is placed on the green with the arrow pointing in the direction of the hole. This method will improve the stability and putting accuracy during play. These and other aspects, features and objects of the invention will be described in more detail below. BRIEF DESCRIPTION OF THE DRAWINGS The following is a brief description of the drawings, which are presented for the purposes of illustrating the invention and not for the purposes of limiting the same. FIG. 1 is a partial sectional view of a preferred embodiment golf ball in accordance with the present invention. FIG. 1 illustrates a preferred mantle and core configuration utilized in this preferred embodiment ball. FIG. 2 is a schematic cross-sectional view of the ball of FIG. 1 , taken across the midsection of the ball. FIG. 3 is a detailed partial cross-sectional view of a preferred core component utilized in the golf balls of the present invention. FIG. 4 is a schematic cross-sectional view of another preferred embodiment golf ball in accordance with the present invention. FIG. 5 is a schematic cross-sectional view of yet another preferred embodiment golf ball in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention relates to a self-correcting golf ball and more particularly to improved components for golf ball construction and the resulting golf balls produced therefrom having controllable flight characteristics. Specifically, according to the invention, golf balls having improved spin stability are provided. The subject golf balls have a high-density material in at least one component or layer that is selectively distributed to provide a spin-stabilizing, gyroscopic center plane. The golf balls of the present invention optionally conform to limitations such as size, weight, and others, for example, as specified by the United States Golf Association (USGA), or in accordance with other promulgated or de facto standards. However, since several embodiments of the self-correcting golf ball of the subject invention are particularly beneficial to beginning and average golfers, it is also advantageous to such golfers that these embodiments be made in excess of USGA or other standards. For example, in certain embodiments where increased distance is desired, the subject golf ball can be optionally made in excess of the USGA maximum weight and/or be of a smaller than standard size. The golf balls of the present invention utilize a selected weight distribution which provides a gyroscopic center plane that stabilizes the spin about a spin axis perpendicular to the center plane. In certain embodiments, the high-density material is applied in various configurations to form high-density regions or longitudinal bands of material which are centered about an equatorial plane of the golf ball. The high density regions or longitudinal bands of material form a gyroscopic center plane of the ball. The high-density material is preferably incorporated into the selected region or regions of a mantle layer or other intermediate layer of the golf ball. As used herein, the term “high-density material” refers to materials having relatively high densities, i.e., that are heavy or have a specific gravity greater than the base polymeric material of the golf ball component. Preferably, the high-density materials have a specific gravity greater than 1.05, more preferably greater than 1.15, and most preferably greater than 1.20. The golf balls of the present invention utilize a core which comprises a single core component or layer, or a multi-layer core configuration having two or more core layers. The core or outer core layer defines a recessed channel extending about the outer circumference of the core along a common plane. A mantle layer is uniformly formed about the core or core assembly. The mantle extends into the recessed channel and has a specific gravity preferably greater than the core. A cover comprising one or more layers is subsequently molded about the mantle and core assembly to form a solid, non-wound golf ball. Referring now to the FIGURES, wherein like reference numerals are used to denote like or analogous components throughout the several views, FIGS. 1 and 2 illustrate a golf ball construction 10 in accordance with a first illustrated embodiment of the present invention. The golf ball 10 comprises a core 12 , a mantle 30 disposed on the core 12 , and a cover 40 disposed on the mantle 30 . The core 12 defines a recessed region 14 extending about the circumference of the core along a common plane. The recessed region 14 in turn is defined by a channel formed from a recessed inner surface 20 and a pair of opposing walls 16 and 18 extending from the surface 20 to the outer surface of the core 12 . The mantle 30 , as described in greater detail herein, is formed such that it occupies or extends into the region within the recessed channel extending about the core 12 . This aspect is further illustrated in FIG. 2 . This portion of the mantle, as described in greater detail herein, forms a longitudinal band extending about the core 12 . Moreover, as will be appreciated, the cover layer 40 defines a plurality of dimples 44 defined along the outer surface 42 of the cover 40 . The recessed region 14 defined within the core 12 , which in turn enables the formation of the longitudinal band formed of the material constituting the mantle 30 , is oriented such that the resulting band extends within the ball's gyroscopic center plane P. The center plane P is perpendicular to the desired or designated spin or rotational axis of the ball, shown in FIGS. 1 and 2 as axis A. The weight band formed by recessed region 14 is formed of a composite mantle material having a higher density relative to the core body 12 . Preferably, the composite mantle material comprises one or more high-density materials incorporated into a polymeric matrix material, which may be the same as or different from the polymer employed in the core body 12 . Irrespective of the material used to form the high density region or band, the core and mantle can be made by a number of methods. For example, the complimentary shape of the core body 12 can be achieved by molding to the desired final shape, or alternatively providing a spherical member and selectively removing material to achieve the desired shape, e.g., by cutting, ablation, and the like. The mantle can be in the form of either a solid composite material which is molded or cast in the desired pattern, for use with a separately formed core body 12 with a built-in recessed area or to be used in a comolding process. A particulate or fibrous material can be incorporated into the composite as a filler material in the desired regions. The high-density particles may be in the form of powders, granules, flakes, fragments, fibers, whiskers, chopped fibers, milled fibers, and so forth. This is described further in more detail below. Exemplary high-density materials which may be incorporated in accordance with the present invention to produce the desired weight distribution include, but are not limited to, metals or metal alloys (e.g., solid, powder or other form of bismuth, boron, brass, bronze, cobalt, copper, inconel metal, iron powder, molybdenum, nickel, stainless steel, tungsten, titanium powder, aluminum and the like), metal coated filaments (e.g., nickel, silver, or copper coated graphite fiber or filament and the like), carbonaceous materials (e.g., graphite, carbon black, cotton flock, leather fiber, etc.), aramid fibers (e.g., Kevlar®, Twaron®, or other aramid fibers), alumina, aluminosilicate, quartz, rayon, silica, silicon carbide, silicon nitride, silicon carbonitride, silicon oxycarbonitride, titania, titanium boride, titanium carbide, zirconia toughened alumina, zirconium oxide, black glass ceramic, boron and boron containing particles or fibers (e.g., boron on titania, boron on tungsten, and so forth), boron carbide, boron nitride, ceramics, glass (e.g., A-glass, AR-glass, C-glass, D-glass, E-glass, R-glass, S-glass, S1-glass, S2-glass, and other suitable types of glass), high melting polyolefins (e.g., Spectra® fibers), high strength polyethylene, liquid crystalline polymers, nylon, paraphenylene terephthalamide, polyetheretherketone (PEEK), polyetherketone (PEK), polyacrylonitrile, polyamide, polyarylate fibers, polybenzimidazole (PBI), polybenzothiazole (PBT), polybenzoxazole (PBO), polybenzthiazole (PBT), polyester, polyethylene, polyethylene 2,6 naftalene dicarboxylate (PEN), polyethylene phthalate, polyethylene terephthalate, polyvinyl halides, such as polyvinyl chloride, other specialty polymers, and so forth. Mixtures of any such suitable materials may also be employed in order to obtain the high density desired. When a particulate high-density material is employed, the particles can range in size from about 5 mesh to about 1 micron, preferably about 20 mesh to about 325 mesh and most preferably about 100 mesh to about 1 micron. Examples of various suitable heavy filler materials which can be used as the high-density material are listed below. TABLE 1 Filler Type Specific Gravity Metals and Alloys (powders) titanium 4.51 tungsten 19.35 aluminum 2.70 bismuth 9.78 nickel 8.90 molybdenum 10.2 iron 7.86 copper 8.94 brass 8.2-8.4 boron 2.364 bronze 8.70-8.74 cobalt 8.92 beryllium 1.84 zinc 7.14 tin 7.31 Metal Oxides zinc oxide 5.57 iron oxide 5.1 aluminum oxide 4.0 titanium dioxide 3.9-4.1 magnesium oxide 3.3-3.5 zirconium oxide 5.73 Metal Stearates zinc stearate 1.09 calcium stearate 1.03 barium stearate 1.23 lithium stearate 1.01 magnesium stearate 1.03 Other graphite fibers 1.5-1.8 precipitated hydrated silica 2.0 clay 2.62 talc 2.85 asbestos 2.5 glass fibers 2.55 Kevlar ® fibers 1.44 mica 2.8 calcium metasilicate 2.9 barium sulfate 4.6 zinc sulfide 4.1 silicates 2.1 diatomaceous earth 2.3 calcium carbonate 2.71 magnesium carbonatel 2.20 Particulate carbonaceous materials graphite 1.5-1.8 carbon black 1.8 natural bitumen 1.2-1.4 cotton flock 1.3-1.4 cellulose flock 1.15-1.5  leather fiber 1.2-1.4 The amount and type of heavy weight filler material utilized is dependent upon the overall characteristics of the self-correcting golf ball desired. Generally, lesser amounts of high specific gravity materials are necessary to produce a desired weight distribution in comparison to low specific gravity materials. Furthermore, other factors, such as handling and processing conditions, can also affect the type and amount of heavy weight filler material incorporated into the high-density regions. The term “density reducing filler” as used herein refers to materials having relatively low densities, i.e., that are lightweight or have a specific gravity less than the specific gravity of the base polybutadiene rubber of 0.91. Examples of these materials include lightweight filler materials typically used to reduce the weight of a product in which they are incorporated. Specific examples include, for instance, foams and other materials having a relatively large void volume. Typically, such filler materials have specific gravities less than 1.0. A density-reducing filler can be used in other ball components to offset the weight increase due to the dense material in regions, such as when it is desired to provide a golf ball which is in conformance with weight restrictions. The density-reducing filler can also be used to adjust one or more desired properties, such as the MOI, COR, and others. The different types of composite materials utilized to form the core, mantle and cover materials are more specifically defined below. However, by creating a core with a peripheral, high-density continuous band around the spin axis A, the finished golf ball produced will exhibit a spin correcting gyroscopic effect. In this regard, the weight band forms a gyroscopic center plane P that is centered about spin axis A as described above. The core 12 and the mantle layer 30 are covered by a single cover layer 40 , although multiple cover layers are also contemplated. The mantle layer 30 should be as thin as possible to maximize the weight concentration in the continuous band. A thick heavy mantle is not desirable as it would reduce the connecting effect and may increase the ball weight beyond the 1.620 ounces maximum USGA ball weight. FIG. 3 is a detailed partial cross-sectional view of a core 112 defining a recessed region 114 extending about its outer periphery. The recessed region is defined by a pair of opposing walls 116 and 118 and an interior surface 120 extending therebetween. The dimensions of the recessed region formed from walls 116 and 118 , and surface 120 may vary depending upon the particular application and properties of the resulting golf ball desired. The depth of the recessed region 114 , designated as dimension D, may range from about 0.050 inches to about 0.300 inches. The width of the recessed region, designated as W, may range from about 0.100 inches to about 0.500 inches. Preferably, the width W ranges from about 0.100 inches to about 0.250 inches. It will be appreciated that the present invention includes channels and regions of greater or lesser dimensions. Furthermore, it is generally preferred that the walls 116 and 118 are parallel with each other and extend at right angles with the surface 120 . However, it is contemplated that the angle between either of the walls 116 and 118 with that of the surface 120 may be round or at an angle greater than 90°. Additionally, it is contemplated that the angle between either of the walls 116 and 118 and that of the face 120 may be at an angle less than 90°. This latter configuration would promote interlocking between the core 112 and an adjacent mantle layer extending about the core 112 . As previously noted, the present invention includes golf ball embodiments having various combinations of cover layers and core assembly configurations. FIG. 4 illustrates another preferred embodiment golf ball 200 . In this embodiment, the golf ball 200 includes a core 212 , a mantle 230 disposed on and generally extending about the core 212 , a first cover layer 240 disposed on and extending about the mantle 230 , and an outer cover layer 250 disposed on the inner cover layer 240 . The outer cover layer 250 defines an outer surface 252 . As will be appreciated, it is preferred that a plurality of dimples (not shown) are defined along the outer surface 252 . The core 212 defines a recessed region 214 extending about the outer periphery of the core 212 . The recessed region 214 is defined by a pair of opposing walls 216 and 218 , that extend between an inner face 220 and the outer region of the core 212 . Again, as previously described, it is preferred that the recessed region formed by walls 216 , 218 and face 220 is generally co-planar or extends within the center plane of the ball 200 and therefore is generally oriented at right angles with respect to axis A. The characteristics of the recessed region of the ball 200 are preferably as described with respect to FIG. 3 . FIG. 5 illustrates another preferred embodiment golf ball 300 in accordance with the present invention. The golf ball 300 includes a center core component 302 and an outer core component 312 disposed on and generally encircling and encapsulating the inner core component 302 . The core components 302 and 312 may be selectively tailored to impart particular properties and characteristics to the ball 300 . For example, the components 302 and 312 may have different densities, C.O.R.'s and each may be formed from a wide array of materials. The outer core component 312 defines a recessed region 314 extending about its outer periphery and which is defined by a pair of opposing walls 316 and 318 that extend between an inner face surface 320 and the outer region of the core component 312 . Disposed on the core assembly of components 302 and 312 , is a mantle 330 . The golf ball 300 also comprises a cover 340 having an outer surface 342 . As will be appreciated, a plurality of dimples (not shown) are defined along the outer surface of the cover 340 . It will be recognized that each of the illustrated embodiments is exemplary and explanatory only. Various other combinations of discrete and continuous bands or channels of high-density material in the composite materials of one or more cover and core layers are also contemplated. Metal particles, or other heavy weight (high-density) filler materials may be included in the composite materials to form the longitudinal axis region(s) or channel(s) in order to increase the density in these regions to provide the gyroscopic effect. The continuous longitudinal weighted region(s) or channel(s) are configured as annular bands centered about the spin axis as a representative of the gyroscopic center plane, and may be a region doped with a high-density material. The high-density materials preferably have a specific gravity of greater than 1.05, preferably greater than 1.15, more preferably greater than 1.2, and even more preferably greater than 1.3. Particulate materials are provided in an amount ranging from about 1 to about 1500 parts per hundred parts resin (phr), preferably from about 4 to about 1400 phr, and more preferably from about 10 to about 1200 phr. In certain embodiments, the core, mantle layer, or cover component or components carrying the weighted regions are configured in a manner analogous to conventional components. However, these components are modified to provide the high-density and/or low-density regions. For example, a core body is compression molded in the typical manner from a slug of uncured or lightly cured elastomer composition comprising a high cis-content polybutadiene and a metal salt of an α, β, ethylenically unsaturated carboxylic acid such as zinc mono or diacrylate or methacrylate. Additives can optionally be added to achieve higher coefficients of restitution in the core. The manufacturer may include a small amount of a metal oxide such as zinc oxide. In addition, larger amounts of metal oxide than those that are needed to achieve the desired coefficient may be included in order to increase the core weight so that the finished ball more closely approaches the USGA upper weight limit of 1.620 ounces. Other materials may be used in the core composition including compatible rubbers or ionomers, and low molecular weight fatty acids such as stearic acid. Free radical initiator catalysts such as peroxides are admixed with the core composition so that on the application of heat and pressure, a complex curing or cross-linking reaction takes place. Core components having high-density regions can be formed in a number of ways. For example, a core body, i.e., a one-piece solid core, or an outer component of a multilayer core is generally spherical, but with an annular, surface depression or channel, which corresponds to the location of the high-density region. This may be accomplished, for example, by using well-known compression or injection molding techniques with an appropriately shaped mold. Alternately, a spherical component is first molded and corresponding depressions or channels are subsequently formed at a later stage, by material removal after the core component hardens or solidifies. Material removal is performed, for example, by cutting, grinding, ablation, routing, abrasion, or the like. The high-density regions are then formed in the depressions or channels by filling with a high-density composite material, co-molding with a polymer doped with a high-density filler material, and the like. A co-molding process is advantageous in that a chemical fusion is formed between the parts. When a multiple core component is produced, the layers are formed by molding processes currently well known in the golf ball art. Specifically, the golf balls can be produced by injection molding, compression molding, or a similar molding technique, an outer core layer about a smaller, previously molded inner core. Likewise, one or more cover layers are molded about the previously molded single or multi-layer cores or mantle assemblies, with the weighted regions, if any, being formed therein in like manner. The cover layer (or outer cover layer in multi-layer cover golf balls) is molded to produce a dimpled golf ball, preferably having a diameter of 1.680 inches or more. After molding, the golf balls produced may undergo various further processing steps such as buffing, painting, marking, and so forth. The core component comprises one or more layers comprising a matrix material selected from thermosets, thermoplastics, and combinations thereof. When a dual- or multi-layer core is utilized, the matrix material and other formulation components, as described in greater detail below, in the various layers may be the same or different composition. The outer diameter of the core component may vary in size and is preferably from about 1.30 inches to 1.610 inches, and is most preferably from about 1.47 inches to 1.56 inches. The core compositions and resulting molded core layer or layers of the present invention are manufactured using relatively conventional techniques. In this regard, the core compositions of the invention preferably are based on a variety of materials, particularly the conventional rubber based materials such as cis-1,4 polybutadiene and mixtures of polybutadiene with other elastomers blended together with crosslinking agents, a free radical initiator, specific gravity controlling fillers, and the like. Natural rubber, isoprene rubber, EPR, EPDM, styrene-butadiene rubber, or similar thermoset materials may be appropriately incorporated into the base rubber composition of the butadiene rubber to form the rubber component. It is preferred to use butadiene rubber as a base material of the composition for the one or more core layers. Thus, in the embodiments using a multi-layer core, the same rubber composition, including the rubber base, free radical initiator, and modifying ingredients, can be used in each layer. Different specific gravity controlling fillers or amounts can be used to selectively adjust the weight or moment of inertia of the finished golf ball. Different cross-linking agents can be used to adjust the hardness or resiliency of the different core layers. However, different compositions can readily be used in the different layers, including thermoplastic materials such as a thermoplastic elastomer or a thermoplastic rubber, or a thermoset rubber or thermoset elastomer material. Some examples of materials suitable for use as the one or more core layers further include, in addition to the above materials, polyether or polyester thermoplastic urethanes, thermoset polyurethanes or metallocene polymers, or blends thereof. Examples of a thermoset material include a rubber based, castable urethane or a silicone rubber. More particularly, a wide array of thermoset materials can be utilized in the core components of the present invention. Examples of suitable thermoset materials include polybutadiene, polyisoprene, styrene/butadiene, ethylene propylene diene terpolymers, natural rubber polyolefins, polyurethanes, silicones, polyureas, or virtually any irreversibly cross-linkable resin system. It is also contemplated that epoxy, phenolic, and an array of unsaturated polyester resins could be utilized. The thermoplastic material utilized in the present invention golf balls and, particularly the cores, may be nearly any thermoplastic material. Examples of typical thermoplastic materials for incorporation in the golf balls of the present invention include, but are not limited to, ionomers, polyurethane thermoplastic elastomers, and combinations thereof. It is also contemplated that a wide array of other thermoplastic materials could be utilized, such as polysulfones, polyamide-imides, polyarylates, polyaryletherketones, polyaryl sulfones/polyether sulfones, polyether-imides, polyimides, liquid crystal polymers, polyphenylene sulfides; and specialty high-performance resins, which would include fluoropolymers, polybenzimidazole, and ultrahigh molecular weight polyethylenes. Additional examples of suitable thermoplastics include metallocenes, polyvinyl chlorides, polyvinyl acetates, acrylonitrile-butadiene-styrenes, acrylics, styrene-acrylonitriles, styrene-maleic anhydrides, polyamides (nylons), polycarbonates, polybutylene terephthalates, polyethylene terephthalates, polyphenylene ethers/polyphenylene oxides, reinforced polypropylenes, and high-impact polystyrenes. Preferably, the thermoplastic materials have relatively high melting points, such as a melting point of at least about 300° F. Several examples of these preferred thermoplastic materials and which are commercially available include, but are not limited to, Capron™ (a blend of nylon and ionomer), Lexan™ polycarbonate, Pebax® polyetheramide and Hytrel™ polyesteramide. The polymers or resin systems may be cross-linked by a variety of means, such as by peroxide agents, sulphur agents, radiation, or other cross-linking techniques, if applicable. However, the use of peroxide crosslinking agents is generally preferred in the present invention. Any or all of the previously described components in the cores of the golf ball of the present invention may be formed in such a manner, or have suitable fillers added, so that their resulting density is decreased or increased. The core component of the present invention is manufactured using relatively conventional techniques. In this regard, the preferred compositions for the one or more core layers of the invention may be based on polybutadiene, and mixtures of polybutadiene with other elastomers. It is preferred that the base elastomer have a relatively high molecular weight. The broad range for the molecular weight of suitable base elastomers is from about 50,000 to about 500,000. A more preferred range for the molecular weight of the base elastomer is from about 100,000 to about 500,000. As a base elastomer for the core composition, cis-polybutadiene is preferably employed, or a blend of cis-polybutadiene with other elastomers such as polyisoprene may also be utilized. Most preferably, cis-polybutadiene having a weight-average molecular weight of from about 100,000 to about 500,000 is employed. Elastomers are commercially available and are well known in the golf ball art. Metal carboxylate crosslinking agents are optionally included in the one or more core layers. The unsaturated carboxylic acid component of the core composition (a co-crosslinking agent) is the reaction product of the selected carboxylic acid or acids and an oxide or carbonate of a metal, such as zinc, magnesium, barium, calcium, lithium, sodium, potassium, cadmium, lead, tin, and the like. Preferably, the oxides of polyvalent metals such as zinc, magnesium and cadmium are used, and most preferably, the oxide is zinc oxide. Exemplary of the unsaturated carboxylic acids which find utility in the present core compositions are acrylic acid, methacrylic acid, itaconic acid, crotonic acid, sorbic acid, and the like, and mixtures thereof. Preferably, the acid component is either acrylic or methacrylic acid. Usually, from about 12 to about 40, and preferably from about 15 to about 35 parts by weight of the carboxylic acid salt, such as zinc diacrylate, is included in the one or more core layers. The unsaturated carboxylic acids and metal salts thereof are generally soluble in the elastomeric base, or are readily dispersed. The free radical initiator included in the core compositions is any known polymerization initiator (a co-crosslinking agent) which decomposes during the cure cycle. The term “free radical initiator” as used herein refers to a chemical which, when added to a mixture of the elastomeric blend and a metal salt of an unsaturated, carboxylic acid, promotes crosslinking of the elastomers by the metal salt of the unsaturated carboxylic acid. The amount of the selected initiator present is dictated only by the requirements of catalytic activity as a polymerization initiator. Suitable initiators include peroxides, persulfates, azo compounds and hydrazides. Peroxides are readily commercially available and known in the art. They are conveniently used in the present invention, generally in amounts of from about 0.5 to about 4.0 and preferably in amounts of from about 1.0 to about 3.0 parts by weight per each 100 parts of elastomer and based on 40% active peroxide with 60% inert filler. Exemplary of suitable peroxides for the purposes of the present invention are dicumyl peroxide, n-butyl 4,4′-bis (butylperoxy) valerate, 1,1-bis(t-butylperoxy)-3,3,5-trimethyl cyclohexane, di-t-butyl peroxide and 2,5-di-(t-butylperoxy)-2,5 dimethyl hexane and the like, as well as mixtures thereof. It will be understood that the total amount of initiators used will vary depending on the specific end product desired and the particular initiators employed. The core compositions of the present invention may additionally contain any other suitable and compatible modifying ingredients including, but not limited to, metal oxides, fatty acids, diisocyanates, and polypropylene powder resin. Various activators may also be included in the compositions of the present invention. For example, zinc oxide, calcium oxide and/or magnesium oxide are activators for the polybutadiene. The activator can range from about 2 to about 30 parts by weight per 100 parts by weight of the rubbers (phr) component. Fatty acids or metallic salts of fatty acids may also be included in the compositions, functioning to improve moldability and processing. Generally, free fatty acids having from about 10 to about 40 carbon atoms, and preferably having from about 15 to about 20 carbon atoms, are used. Exemplary of suitable fatty acids are stearic acid and linoleic acids, as well as mixtures thereof. Exemplary of suitable metallic salts of fatty acids include zinc stearate. When included in the core compositions, the fatty acid component is present in amounts of from about 1 to about 25, preferably in amounts from about 2 to about 15 parts by weight based on 100 parts rubber (elastomer). It is preferred that the core compositions include zinc stearate as the metallic salt of a fatty acid in an amount of from about 2 to about 20 parts by weight per 100 parts of rubber. Diisocyanates may also be optionally included in the core compositions. The diisocyanates act here as moisture scavengers. When utilized, the diioscyanates are included in amounts of from about 0.2 to about 5.0 parts by weight based on 100 parts rubber. Exemplary of suitable diisocyanates is 4,4′-diphenylmethane diisocyanate and other polyfunctional isocyanates known to the art. Furthermore, the dialkyl tin difatty acids set forth in U.S. Pat. No. 4,844,471, the dispersing agents disclosed in U.S. Pat. No. 4,838,556, and the dithiocarbamates set forth in U.S. Pat. No. 4,852,884 may also be incorporated into the polybutadiene compositions of the present invention. The specific types and amounts of such additives are set forth in the above identified patents, which are incorporated herein by reference in its entirety. The preferred core components of the invention are generally comprised of 100 parts by weight of a base elastomer (or rubber) selected from polybutadiene and mixtures of polybutadiene with other elastomers, such as polyisoprene, 12 to 40 parts by weight of at least one metallic salt of an unsaturated carboxylic acid, and 0.5 to 4.0 parts by weight of a free radical initiator (40% active peroxide). However, as mentioned above, the use of at least one metallic salt of an unsaturated carboxylic acid is preferably not included in the formulation of the high-density center core layer. In addition to polybutadiene, the following commercially available thermoplastic resins are also particularly suitable for use in the noted dual cores employed in the golf balls of the present invention: Capron™ 8351 (available from Allied Signal Plastics), Lexan™ ML5776 (from General Electric), Pebax® 3533 (a polyether block amide from Elf Atochem), and Hytrel™ G4074 (a polyether ester from DuPont). In addition, various polyisoprenes may also be included in the core components of the present invention. As mentioned above, the present invention includes golf ball embodiments that utilize one or more core components. For multiple-component cores, a core assembly is provided that comprises a central core component and one or more core layers disposed about the central core component. The second, third, and higher numbers of core layers may be the same as or different from each other and the central core layer. In producing the golf ball single component cores, and the center or outer layers of multi-component cores, the desired ingredients are intimately mixed, for instance, using two roll mills or a Banbury™ mixer until the composition is uniform, usually over a period of from about 5 to about 20 minutes. The sequence of addition of components is not critical. A preferred blending sequence is described below. The matrix material or elastomer, powdered metal zinc salt (if desired), a high specific gravity additive such as powdered metal (if desired), a low specific gravity additive (if desired), metal oxide, fatty acid, and the metallic dithiocarbamate (if desired), surfactant (if desired), and tin difatty acid (if desired), are blended for about 7 minutes in an internal mixer such as a Banbury™ mixer. As a result of shear during mixing, the temperature rises to about 200° F. The mixing is desirably conducted in such a manner that the composition does not reach incipient polymerization temperatures during the blending of the various components. The initiator and diisocyanate are then added and the mixing continued until the temperature reaches about 220° F. whereupon the batch is discharged onto a two roll mill, mixed for about one minute and sheeted out. The sheet is rolled into a “pig” and then placed in a Barwell™ preformer and slugs of the desired weight are produced. The slugs to be used for the core (or center core layer) are then subjected to compression molding at about 140° C. to about 170° C. for about 10 to 50 minutes. Note that the temperature in the molding process is not always required to be constant, and may be changed in two or more steps. In fact, the slugs for the outer core layer are frequently preheated for about one-half hour at about 75° C. prior to molding. After molding, the molded cores (or center layer thereof for multi-component cores) are cooled, the cooling effected, for example, at room temperature for about 4 hours or in cold water for about one hour. The molded cores/center core layers are subjected to a centerless grinding operation whereby a thin layer of the molded core is removed to produce a round center. Alternatively, the cores/center layers are used in the as-molded state with no grinding needed to achieve roundness. The center is converted into a dual- or multi-layer core by providing at least one layer of core material thereon, which again, may be of similar or different matrix material as the center. Preferably, the outer core layer(s), where present, comprises polybutadiene. Optionally, for example, where a golf ball meeting specified weight requirements is desired, one or more of the inner and outer core layers are weight-adjusted to compensate for the spin-correcting, high-density equatorial regions. In producing a multi-component core, the one or more outer core layers can be applied around the spherical center by several different types of molding processes. For example, the compression molding process for forming the cover layer(s) of a golf ball that is set forth in U.S. Pat. No. 3,819,795, incorporated herein by reference in its entirety, can be adapted for use in producing the core layer(s) of the present invention. In such a modified process, preforms or slugs of the outer core material, i.e., the thermoset material utilized to form the outer core layer, are placed in the upwardly open, bottom cavities of a lower mold member of a compression molding assembly, such as a conventional golf ball or core platen press. The upwardly facing hemispherical cavities have inside diameters substantially equal to the finished core to be formed. In this regard, the inside diameters of the cavities are slightly larger (i.e., approximately 2.0 percent larger) than the desired finished core size in order to account for material shrinkage. An intermediate mold member comprising a center Teflon®-coated plate having oppositely-affixed hemispherical protrusions extending upwardly on the upper surface and extending downwardly on the lower surface, each hemispherical protrusion sized to be substantially equal to the centers to be utilized and thus can vary with the various sizes of the centers to be used. Additional preforms of the same outer core material are subsequently placed on top of the upwardly-projecting hemispherical protrusions affixed to the upper surfaces of the Teflon®-coated plate of the intermediate mold member. The additional preforms are then covered by the downwardly open cavities of the top mold member. Again the downward facing cavities of the top mold member have inside diameters substantially equal to the core to be formed. Specifically, the bottom mold member is engaged with the top mold member with the intermediate mold member having the oppositely protruding hemispheres being present in the middle of the assembly. The mold members are then compressed together to form hemispherical core halves. In this regard, the mold assembly is placed in a press and cold formed at room temperature using approximately 10 tons of pressure in a steam press. The molding assembly is closed and heated below the cure activation temperature of about 150° F. for approximately four minutes to soften and mold the outer core layer materials. While still under compression, but at the end of the compression cycle, the mold members are water cooled to a temperature to less than 100EF in order to maintain material integrity for the final molding step. This cooling step is beneficial since cross linking has not yet proceeded to provide internal chemical bonds to provide full material integrity. After cooling, the pressure is released. The molding assembly is then opened, the upper and lower mold members are separated, and the intermediate mold member is removed while maintaining the formed outer core layer halves in their respective cavities. Each of the halves has an essentially perfectly formed one-half shell cavity or depression in its uncured thermoset material. These one-half shell cavities or depressions were produced by the hemispherical protrusions of the intermediate mold member. Previously molded centers are then placed into the bottom cavities or depressions of the uncured thermoset material. The top portion of the molding assembly is subsequently engaged with the bottom portion and the material that is disposed therebetween is cured for about 12 minutes at about 320° F. Those of ordinary skill in the art relating to free radical curing agents for polymers are conversant with adjustments of cure times and temperatures required to effect optimum results with any specific free radical agent. The combination of the high temperature and the compression force joins the core halves, and bonds the cores to the center. This process results in a substantially continuously outer core layer being formed around the center component. In an alternative, and in some instances, more preferable compression molding process, the Teflon®-coated plate of the intermediate mold member has only a set of downwardly projecting hemispherical protrusions and no oppositely affixed upwardly-projecting hemispherical protrusions. Substituted for the upwardly-projecting protrusions are a plurality of hemispherical recesses in the upper surface of the plate. Each recess is located in the upper surface of the plate opposite a protrusion extending downwardly from the lower surface. The recess has an inside diameter substantially equal to the center to be utilized and is configured to receive the bottom half of the center. The previously molded centers are then placed in the cavities located on the upper surface of the plate of the intermediate mold member. Each of the centers extends above the upper surface of the plate of the intermediate mold member and is pressed into the lower surface of the upper preform when the molds are initially brought together during initial compression. The molds are then separated and the plate removed, with the centers being retained (pressed into) the half shells of the upper preforms. Mating cavities or depressions are also formed in the half shells of the lower preforms by the downwardly projecting protrusions of the intermediate mold member. With the plate now removed, the top portion of the molding assembly is then joined with the bottom portion. In so doing, the centers projecting from the half shells of the upper performs enter into the cavities or depressions formed in the half shells of the lower preforms. The material included in the molds is subsequently compressed, treated and cured as stated above to form a golf ball core having a centrally located center and an outer core layer. This process can continue for any additional added core layers. After molding, the core (optionally surrounded by one or more outer core layers) is removed from the mold and the surface thereof preferably is treated to facilitate adhesion thereof to the covering materials. Surface treatment can be effected by any of the several techniques known in the art, such as corona discharge, ozone treatment, sand blasting, brush tumbling, and the like. Preferably, surface treatment is effected by grinding with an abrasive wheel. As stated above, the golf balls of the subject invention may include a mantle and/or a cover, which may comprise a single layer or multiple layers. The mantle compositions and resulting mantle layers of the present invention are produced as follows. In this regard, mantle compositions of the invention preferably are based on a variety of materials, particularly the conventional rubber based materials such as cis-1,4 polybutadiene and mixtures of polybutadiene with other elastomers blended together with crosslinking agents, a free radical initiator, specific gravity controlling fillers and the like. Materials previously discussed for use in the core can also be used in the mantle. Any or all of the previously described components in the core or mantle of the golf ball of the present invention may be formed in such a manner, or have suitable fillers added, so that their resulting density is decreased or increased. For example, heavy weight metals and/or filler materials are incorporated into the mantle or core. As noted herein, the specific gravity of the mantle layer may be either greater than or less than the specific gravity of the core. For embodiments in which the mantle layer has a higher specific gravity than the core, by increasing the specific gravity of the mantle, weight is added to the mantle material disposed in the channel defined in the core. The specific gravity of the core may be adjusted, i.e. decreased, to accommodate for the additional weight in the mantle. Ionomer-based mantles may exhibit specific gravities of about 1.00 while conventional polybutadiene cores may exhibit a specific gravity of about 1.15. The specific gravity of a core with an adjusted specific gravity may be as low as about 1.06. In some versions, the mantle layer is formed as thin as possible to produce a finished ball weight of 46 grams or less. Alternatively, the specific gravity of the core may be increased relative to that of the mantle layer. The increased weight of the core will assist in orienting the core during ball flight. Referring now to dual- and multi-layer covers, the inner cover layer is preferably in one embodiment harder than the outer cover layer and generally has a thickness in the range of 0.01 to 0.10 inches, preferably 0.03 to 0.07 inches for a 1.68 inch ball and 0.05 to 0.10 inches for a 1.72 inch (or more) ball. The core and inner cover layer together form an inner ball having a coefficient of restitution of 0.780 or more and more preferably 0.790 or more, and a diameter in the range of 1.48-1.64 inches for a 1.68 inch ball and 1.50-1.70 inches for a 1.72 inch (or more) ball. The above-described characteristics of the inner cover layer provide an inner ball having a PGA compression of 100 or less. It is found that when the inner ball has a PGA compression of 90 or less, excellent playability results. Materials suitable for the inner cover layer are known in the art. Examples of suitable materials for the inner layer compositions include the high acid and low acid ionomers such as those developed by E.I. DuPont de Nemours & Company under the trademark “Surlyn®” and by Exxon Corporation under the trademark “Escor™” or trade name “lotek”, or blends thereof. Examples of compositions which may be used as the inner layer herein are set forth in detail in U.S. application Ser. No. 09/505,760 (U.S. Pat. No. 6,433,094) which is a continuation-in-part of U.S. application Ser. No. 09/918,860 (U.S. Pat. No. 6,494,792), which is a divisional of U.S. application Ser. No. 08/896,690 (U.S. Pat. No. 6,267,693) which is a continuation of U.S. application Ser. No. 08/174,765, which is a continuation of U.S. application Ser. No. 07/776,803 filed Oct. 15, 1991, and Ser. No. 08/493,089 (U.S. Pat. No. 5,688,869), which is a continuation of Ser. No. 07/981,751, which in turn is a continuation of Ser. No. 07/901,660 filed Jun. 19, 1992, each of which is incorporated herein by reference in its entirety. Of course, the inner layer high acid ionomer compositions are not limited in any way to those compositions set forth in said applications. Additional materials suitable for use as the inner cover layer include low acid ionomers, which are known in the art. Other materials suitable for use as the inner cover layer include fully non-ionomeric thermoplastic materials. Suitable non-ionomeric materials include metallocene catalyzed polyolefins or polyamides, polyamide/ionomer blends, polyphenylene ether/ionomer blends, etc., which have a Shore D hardness of 60 or more and a flex modulus of greater than about 30,000 psi, or other hardness and flex modulus values which are comparable to the properties of the ionomers described above. Other suitable materials include but are not limited to thermoplastic or thermosetting polyurethanes, a polyester elastomer such as that marketed by DuPont under the trademark Hytrel™ (polyester amide), or a polyether amide such as that marketed by Elf Atochem S.A. under the trademark Pebax®, a blend of two or more non-ionomeric thermoplastic elastomers, or a blend of one or more ionomers and one or more non-ionomeric thermoplastic elastomers. Still referring to embodiments having dual- or multi-layer covers, the core component or core and mantle assembly, and the hard inner cover layer formed thereon provide the subject golf ball with power and distance. The outer cover layer is preferably comparatively softer than the inner cover layer. The softness provides for the feel and playability characteristics typically associated with balata or balata-blend balls. The outer cover layer or ply is comprised of a relatively soft, low modulus (about 1,000 psi to about 10,000 psi) and, in an alternate embodiment, low acid (less than 16 weight percent acid) ionomer, an ionomer blend, a non-ionomeric thermoplastic or thermosetting material such as, but not limited to, a metallocene catalyzed polyolefin such as EXACT™ material available from EXXON®, a polyurethane, a polyester amide elastomer such as that marketed by DuPont under the trademark Hytrel™, or a polyether amide such as that marketed by Elf Atochem S.A. under the trademark Pebax®, a blend of two or more non-ionomeric thermoplastic or thermosetting materials, or a blend of one or more ionomers and one or more non-ionomeric thermoplastic materials. The outer layer is fairly thin (i.e. from about 0.010 to about 0.10 inches in thickness, more desirably 0.03 to 0.06 inches in thickness for a 1.680 inch ball and 0.03 to 0.06 inches in thickness for a 1.72 inch or more ball), but thick enough to achieve desired playability characteristics while minimizing expense. Thickness is defined as the average thickness of the non-dimpled areas of the outer cover layer. Preferably, the outer cover layer has a Shore D hardness of at least 1 point softer than the inner cover, although the outer layer may be the same or harder than the inner layer in some embodiments. The outer cover layer of the invention is formed over a core to result in a golf ball having a coefficient of restitution of at least 0.760, more preferably at least 0.770, and most preferably at least 0.780. The coefficient of restitution of the ball will depend upon the properties of both the core and the cover. The PGA compression of the golf ball is 100 or less, and preferably is 90 or less. Additional materials may also be added to the inner and outer cover layer of the present invention as long as they do not substantially reduce the playability properties of the ball. Such materials include dyes (for example, Ultramarine Blue™ sold by Whitaker, Clark, and Daniels of South Plainsfield, N.J.) (see U.S. Pat. No. 4,679,795), pigments such as titanium dioxide, zinc oxide, barium sulfate and zinc sulfate; UV absorbers; optical brighteners such as Eastobrite™ OB-1 and Uvitex™ OB antioxidants; antistatic agents; and stabilizers. Moreover, the cover compositions of the present invention may also contain softening agents such as those disclosed in U.S. Pat. Nos. 5,312,857 and 5,306,760, including plasticizers, metal stearates, processing acids, etc., and reinforcing materials such as glass fibers and inorganic fillers, as long as the desired properties produced by the golf ball covers of the invention are not impaired. It will be appreciated that the present invention provides at least two (2) strategies for improving the spin characteristics of a golf ball. The first technique is to decrease the specific gravity of a core having a channel extending about its outer periphery while increasing the specific gravity of a mantle layer immediately adjacent and alongside the core. Alternatively, another technique is to increase the specific gravity of the core having the equatorial channel defined about its outer periphery while decreasing the specific gravity of the mantle component immediately adjacent to the core. The invention has been described with reference to the preferred embodiment. Obviously, modifications and alterations will occur to others upon reading and understanding the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims and the equivalents thereof.

A golf ball is provided having a controlled weight distribution about a designated spin axis. The golf ball includes a core and mantle assembly defining one or more high density regions interiorly disposed along a common plane and centered about the horizontal spin axis of the ball. As a result of the controlled weight distribution, the resulting ball significantly reduces hooks and slices. A method of manufacturing and/or utilizing the present golf ball is also provided.

CLAIM OF PRIORITY The present invention claims priority to U.S. Provisional patent application no. 60/128,433, filed on Mar. 30, 1999. FIELD OF INVENTION The present invention relates to a pad that provides hypo/hyperthermia properties to a person using the pad. BACKGROUND OF THE INVENTION In U.S. Pat. No. 5,336,708, Chen discloses a gelatinous elastomer composite article. These articles, as disclosed by Chen, “include: GMG, MGM, MG 1 G 2 M, M 1 M 2 G 1 G 2 , M 2 M 1 G 1 G 2 , G 1 MG 1 G 2 , MG 1 G 2 M, G 1 G 2 M, GM 1 M 2 G, G 1 M 1 G 2 M 2 M 1 , M 1 GM 2 GM 3 GM 4 , [sic] ect, where G = gel and M = material The subscript 1, 2, 3, and 4 are different and are represented by n which is a positive number. The material (M) suitable for forming composite articles with the gelatinous elastomer compositions can include foam, plastic fabric, metal, concrete, wood, wire screen, refractory material, glass, synthetic resin, synthetic fibers, and the like. Sandwiches of gel/material . . . are ideal for use as shock absorbers, acoustical isolators, vibration dampers, vibration isolators and wrappers. For example the vibration isolators can be [sic] use under research microscopes, office equipment, tables, and the like to remove background vibrations.” U.S. Pat. No. 5,336,708, col. 3, lines 35-51. Chen further discloses, “generally the molten gelatinous elastomer composition will adhere sufficiently to certain plastics (e.g., acrylic, ethylene copolymers, nylon, polybutylene, polycarbonate, polystyrene, polyester, polyethylene, polypropylene, styrene copolymers, and the like) provided the temperature of the molten gelatinous elastomer composition is [sic] sufficient high to fuse or nearly fuse with the plastic. In order to obtain sufficient adhesion to glass, ceramics, or certain metals, sufficient temperature is also required (e.g., above 250° F. [121° C. ]” U.S. Pat. No. 5,336,708, col. 9, lines 8-18 (brackets added for consistency of temperature comparison). Elkins in U.S. Pat. No. 4,884,304 describes a bedding system with selective heating and cooling of a person. That system has, from top to bottom, in order: a top mattress cover, a gas envelope and a multiplicity of liquid flow channels. The multiplicity of liquid flow channels is accomplished by a conventional hypo/hyperthermia blanket. The details of this conventional blanket are set forth in this patent. A problem with this system occurs when a person is on the mattress cover. When the person is on that mattress cover, the person has two sides: (1) a “contacting side” that touches the mattress cover and (2) the “exposed side” that does not touch the mattress cover. The person disperses the gas envelope and only certain portions of the contacting side contact the flow channels. As shown in FIG. 5 of that patent, the shoulders and other peripheral points of the contacting side of the person, such as arms, do not contact the flow channels. Thereby, that bedding system fails to transfer the desired temperature of the flow channels uniformly to all,sections of the contacting side of the person. M. Figman in U.S. Pat. No. 3,266,064, and von der Heyde in U.S. Pat. No. 5,887,304 illustrate conventional convective medium mattress system which essentially has a lower “box spring” and a mattress made of rubber, foam, or conventional mattress materials that an individual or object lies thereon. In each embodiment, the lower box spring has a cavity that the medium enters and distributes throughout. The medium then escapes from the cavity through apertures of the mattress. A problem with these apertures 89 is that they kink 90 when an adult lies 22 thereon, as shown in FIG. 8 . Please note that von der Heyde's system is designed for an infant, not an adult. And an infant is of such low weight that kinking is essentially nonexistent. When kinking occurs, the medium is prevented from contacting the body. And when the medium does not contact the body, the medium is unable to treat the hypothermia or hyperthermia portions of the patient that contact the mattress, or even cool or heat the portions of the patient that contact the mattress. The present invention solves this problem. SUMMARY OF THE INVENTION The present invention relates to a first conformable material having a three-dimensional shape and a first hypothermia and/or hyperthermia device. BRIEF DESCRIPTION OF THE FIGURES A preferred embodiment of the present invention is described in detail hereinafter with reference to the accompanying drawing, in which: FIG. 1 is a cross-sectional view of the present invention; and FIGS. 2-7 are alternative embodiments of FIG. 1 . FIG. 8 is prior art of an adult patient on a conventional mattress system with apertures. FIG. 9 is the present invention of an adult patient on a gelatinous elastomeric material with apertures. FIG. 10 is an alternative embodiment of the present invention with a conventional blanket. FIG. 11 is an alternative embodiment of FIG. 10 with a convective blanket. FIG. 12 is an alternative embodiment of FIG. 7 . FIG. 13 is an alternative embodiment of FIG. 7 . DETAILED DESCRIPTION OF THE INVENTION FIG. 1 illustrates a pad 10 having a first sealable bag 12 , a first hypothermia and/or hyperthermia device 14 , and a pad cover 16 . The bag 12 contains at least a first conformable material 18 , and a thermally conductive medium 20 . The thermal conductive medium 20 is any liquid or viscous gel that transfers energy generated by the device 14 to a patient (not shown). Examples of this liquid include water, water-based solutions, oil-based solutions, oils, alcohols, mixtures thereof, and viscous gels. The conformable material 18 is any material having apertures that do not easily kink, preferably, a gelatinous elastomeric material. Examples of types of gelatinous materials, which are heat formable and heat reversible, are fully described in U.S. Pat. Nos. 4,369,284, 4,618,213, 5,262,468, 5,336,708, and 5,508,334, which are hereby incorporated by reference herein, and those made by Pittsburgh Plastic. The gelatinous materials manufactured by Pittsburgh Plastic are allegedly distinct from the patented types. This conformable material can be of any shape or design, so long as it has a three-dimensional shape that supports a patient or object on the pad 10 . The hypothermia and/or hyperthermia device 14 is any conventional hypo/hyperthermia blanket—an example of this blanket is the MUL-T-PAD® or the THERMACARE® blanket by Gaymar Industries, Inc. of Orchard Park, N.Y.—and its corresponding pump—the MEDI-THERM II® temperature regulator by Gaymar Industries, Inc. of Orchard Park, N.Y.—, an electric blanket, a cold compress, and a convective device. The convective device pumps or blows air or other gaseous medium (collectively “Air”) having a predetermined temperature. The Air obtains the desired temperature in a conventional Air temperature regulator (for example, an air conditioner, a heat pump, a ThermaCare® blower unit, or the MEDI-THERM II® temperature regulator) and then circulates through a mesh screen like the Air Queen by Teijin, Inc. or a non-woven polymeric device having a plurality, of tubes with numerous apertures therein. The Air is then distributed throughout the entire pad 10 . In any embodiment of device 14 , the device 14 affects the temperature that a patient (not shown) or object (not shown) is exposed to, and, in some embodiments, the medium 20 that encompasses the conformable material 18 . The bag 12 is any sealable instrument that contains at least the thermally conductive medium 20 and conformable material 18 in place. Preferably, the bag 12 is plastic, and it can be sealed thermally, acoustically, by a zipper, zip locked, or even by Velcro®. The pad cover 16 is any conventional material used to cover a pad 10 . The pad cover 16 can encompass the entire pad 10 , the preferred embodiment as shown, or cover the pad 10 like a conventional mattress sheet. In either embodiment the pad cover 16 can be cloth, leather, plastic or conventional cover material. The materials of the pad cover 16 allow the patient or object, on the pad 10 , to feel the desired temperature of the pad 10 (Air or medium 20 ). The pad cover 16 can also allow moisture to pass through it. Thereby, it helps control the patient's temperature and prevents overcooling or overheating. Turning to FIG. 2, a patient 22 disperses a portion of the thermal conductive medium 20 in the bag 12 and contacts at least a portion of the conformable material 18 when the patient 22 lies on the pad 10 . The conformable material 18 provides support to the patient 22 , increases the effective surface contact of the pad 10 to the patient 22 to ensure greater desired thermal conductivity to the patient 22 , maintains the stability of the bag 12 , and reduces the pressure to the patient 22 . By maintaining the stability of the bag 12 , the conformable material 18 ensures the patient (or object) 22 , on the pad 10 , from directly contacting the hypothermia and/or hyperthermia device 14 . In other words, the patient 22 does not “bottom out” to or directly contact the device 14 . In a preferred embodiment, the conformable material 18 has apertures 24 . The apertures 24 , in this embodiment, go from the bottom to the top of the material 18 and ensure the thermal conductive medium 20 is between the patient 22 and the hypothermia and/or hyperthermia device 14 . However, in order to decrease, and essentially avoid, kinking— which is discussed above and, as a reminder, inhibits the medium 20 or the Air from contacting the patient— and which is common in many mattress materials, the preferred embodiment of the conformable material 18 is a gelantinous elastomer material. The gelantinous elastomer material has a structure design that admittedly bends and indents, as shown in FIG. 9, when a patient lies thereon, but does not kink. Thereby, the Air or medium can go through the apertures 24 . The hypothermia and/or hyperthermia device 14 heats or cools the thermal conductive material 20 and the patient 22 to a predetermined temperature. Since the thermal conductive material 20 contacts most, if not all, portions of the contacting side 23 of the patient 22 , the material 20 ensures a uniform, or nearly uniform application of the predetermined temperature to the contacting side 23 . Turning to FIG. 3, the pad 10 contains at least a second bag 12 a . The second bag 12 a has at least a second conformable material 18 a and a second thermal conductive material 20 a . The second thermal conductive material 20 a , the second bag 12 a , and the second conformable material 18 a can be the same or different materials as the previously listed corresponding elements 12 , 18 , 20 . Turning to FIG. 4, an alternative embodiment of FIG. 3 is shown. A second hypothermia and/or hyperthermia device 14 a is positioned under the second bag 12 a . The second hypothermia and/or hyperthermia device 14 a can be set at the same or different temperature as the hypothermia and/or hyperthermia device 14 . Thereby, the first thermally conductive material 20 can apply one temperature to one portion of the contacting side 23 b of the patient 22 and the second thermally conductive material 20 a can apply the same or a different predetermined temperature to another portion contacting side 23 c. Turning to FIG. 5, an alternative embodiment of FIG. 4 is shown. A third conformable material 18 b underlies the hypothermia and/or hyperthermia devices 14 , 14 a . This material 18 b offers further support to the patient 22 , maintains the stability of the bags 12 , 12 a , and further reduces the pressure to the patient 22 . Obviously, this third material 18 b can underlie, or alternatively be over. (not shown), the hypothermia and/or hyperthermia device(s) 14 , 14 a of FIGS. 1-4. Turning to FIG. 6, an alternative embodiment of FIG. 1 is shown. The hyperthermia and/or hypothermia device 14 is within the bag 12 under, or alternatively be over (not shown), the conformable material 18 and surrounded by the thermal conductive medium 20 . In this embodiment, the conventional inlet-outlet 77 of the device 14 , i.e., the pump hoses of the MEDI-THERM II® system, protrudes from the sealed bag 12 . Obviously this embodiment can be used in the other embodiments illustrated in FIGS. 3 and 4. FIG. 7 illustrates an alternative embodiment of FIG. 1, wherein the conformable material is not inserted in a bag 12 or surrounded by a medium 20 . In this embodiment, the hypothermia and/or hyperthermia device 14 is a convective unit and the Air goes through the apertures 24 of the gelatinous elastomer material 18 . FIG. 12 illustrates an alternative embodiment of FIG. 7 . Along with the apertures 24 , the conformable material 18 has a plurality of side apertures 24 a interspaced between the upper wall and a lower wall of the material 18 . Side apertures 24 a receive Air and then distribute the Air throughout the conformable material 18 . In one embodiment (like that shown in FIG. 7) the device 14 is positioned below the conformable material 18 . In yet another embodiment, as shown in FIG. 12, the device 14 is positioned at an end 563 of the conformable material 14 . Thereby the Air goes into the side apertures 24 a and is distributed throughout the conformable material 18 and apertures 24 , to effect the patient's 22 temperature. Turning to FIG. 13, another embodiment of the present invention relates to the positioning of the hypothermia and/or hyperthermia device 14 . The device 14 can also be positioned above the conformable material 18 . The device 14 adjusts the temperature of the air within the pad 10 , and that air cools or heats or maintains the temperature of the patient 22 . The air also circulates through the pad 10 within the apertures 24 (and maybe 24 a ). Turning to FIGS. 10 and 11, the Air of FIG. 7 circulates under the cover 16 , and escapes from, preferably predetermined, a gap 345 in the cover. Extending from gap 345 is a tube 347 , flexible or not, that directs the Air under a conventional blanket 348 , as shown in FIG. 10, or into an aperture 349 of a convective blanket 350 , like the THERMACARE® blanket by Gaymar Industries, Inc., as shown in FIG. 11 . Alternatively, the pad cover 16 has a material that transfers the temperature to the patient but influences the Air to a predetermined gap(s) 345 in the pad 10 . The predetermined gap(s) 345 can be located anywhere within the pad, i.e. at the bottom of the pad, a side of the pad as shown in FIGS. 10 and 11, if necessary, under the patient 22 , or under the blanket 348 directly. Turning to the method of the invention the preferred embodiment of the present invention is as an operating table pad and/or any other structure or object used in an operating.room or hospital-like mattress system, such as bed systems or seat cushions. An operating technician inserts at least one pad 10 , having a hypothermia and/or hyperthermia device 14 , and a conformable material 18 , under a predetermined area of a patient 22 . The technician then adjusts the device 14 to a predetermined temperature, in some instances the device 14 can only obtain one temperature. In either case, the device 14 adjusts the pad 10 to the predetermined temperature. At any time before or after the device 14 is initially adjusted to the predetermined temperature, the patient 22 lies on the pad 10 and the contacting side 23 of the patient 22 will be or is exposed to the predetermined temperature. Although a particular preferred embodiment of the invention has been illustrated and described in detail for illustrative purposes, it will be recognized that variations or modifications of the disclosed apparatus, including the rearrangement of parts, lie within the scope of the invention defined by the claims.

A first conformable material having a three-dimensional shape and a first hypothermia and/or hyperthermia device, used as a pad for sleeping, lying down, or sitting, to maintain a desired temperature to the contacting surface of a body to the pad.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority from U.S. Provisional Patent Application Ser. No. 60/587,871, filed Jul. 15, 2004, the disclosure of which is hereby incorporated by reference in its entirety. FIELD OF INVENTION [0002] This invention relates, generally, to therapeutic methods and compositions for the treatment of calcification and/or plaque-based conditions and/or diseases associated with the presence of extraneous agents in human and animal blood, sera, or other fluids comprised of self-replicating calcium phosphate macromolecular complexes termed Nanobacteria or Calcifying Nano-Particles. The methods of treatment and compositions include the combination of nutritional supplements, vitamins, herbal supplements, antibiotics, and metal chelators used separately or, more preferably, in concert. BACKGROUND OF THE INVENTION [0003] Biomineralization refers, generally to the formation of discrete and organized inorganic crystalline structures within macromolecular extra cellular matrices, including, for example, the formation of calcium phosphate or crystalline hydroxy apatite. Calcification is a biomineralization process in which calcium phosphate is deposited in tissue. [0004] Examples of normal, healthy calcification include the formation of mammalian bone and dental enamel. Pathological calcification, however, has been observed to characterize a number of diseases, including but not limited to, for example, heart or circulatory diseases such as Arteriosclerosis, Atherosclerosis, Coronary Heart Disease, Chronic Heart Failure, Valve Calcifications, Arterial Aneurysms, Calcific Aortic Stenosis, Transient Cerebral Ischemia, Stroke, Peripheral Vascular Disease, Monckeberg's Disease, Vascular Thrombosis; Dental Diseases such as Dental Plaque, Gum Disease (dental pulp stones), calcification of the dentinal papilla, and Salivary Gland Stones; Chronic Infection Syndromes such as Chronic Fatigue Syndrome; Kidney and Bladder Stones, Gall Stones, Pancreas and Bowel Diseases such as Pancreatic Duct Stones, Crohn's Disease, Colitis Ulcerosa; Blood disorders; Adrenal Calcification; Liver Diseases such as Liver Cirrhosis and Liver Cysts; Testicular Microliths, Chronic Calculous Prostatitis, Prostate Calcification, Calcification in Hemodialysis Patients, Malacoplakia; Autoimmune Diseases such as Lupus Erythematosous, Schleroderma, Dermatomyositis, Cutaneous polyarteritis, Panniculitis (Septal and Lobular), Antiphospholipid Syndrome, Arteritis Nodosa, Thrombocytopenia, Hemolytic Anemia, Myelitis, Livedo Reticularis, Chorea, Migraine, Junvenile Dermatomyositis, Graves Disease, Chronic Thyroiditis, Hypothyreoidism, Type 1 Diabetes Mellitis, Addison's Disease, and Hypopituitarism; Placental and Fetal Disorders, Polycystic Kidney Disease, Glomerulopathies; Eye Diseases such as Corneal Calcifications, Cataracts, Macular Degeneration and Retinal Vasculature-derived Processes and other Retinal Degenerations; Retinal Nerve Degeneration, Retinitis, and Iritis; Ear Diseases such as Otosclerosis, Degeneration of Otoliths and Symptoms from the Vestibular Organ and Inner Ear (Vertigo and Tinnitus); Thyroglossal cysts, Thyroid Cysts, Ovarian Cysts; Cancer such as Meningiomas, Breast Cancer, Prostate Cancer, Thyroid Cancer, Serous Ovarian Adenocarcinoma; Skin diseases such as Calcinosis Cutis, Skin Stones, Calciphylaxis, Psoriasis, Eczema, Lichen Ruber Planus or Lichen Simple Cysts; Choroid Plexus Calcification, Neuronal Calcification, Calcification of the Falx Cerebri, Calcification of the Intervertebral Cartilage or Disc, Intercranial or Cerebral Calcification, Rheumatoid Arthritis, Calcific Tenditis, Oseoarthritis, Fibromyalgia, Bone Spurs, Diffuse Interstitial Skeletal Hyperostosis, Intracranial Calcifications such as Degenerative Disease Processes and Dementia; Erythrocyte-Related Diseases involving Anemia, Intraerythrocytic Nanobacterial Infection and Splenci Calcifications; Chronic Obstructive Pulmonary Disease, Broncholiths, Bronchial Stones, Neuropathy, Calcifications and Encrustations of Implants, Mixed Calcified Biofilms, and Myelodegenerative Disorders such as Multiple Sclerosis, Lou Gehrig's, and Alzheimer's Disease. Although the cause of pathological calcification remains unknown, it has been observed that each of the foregoing conditions is often associated with the presence of a very small, mineral-associated bacteria-like self-replicating calcium-phosphate macromolecular complexes forms termed Nanobacteria (Nanobacterium sanguineum) or Calcifying Nano-Particles which are known for their ability to create calcium phosphate coated vesicles or nanoparticles that multiply in blood and in cell culture medium like living cells. Nanobacteria (“NB”) or Calcifying Nano-Particles (“CNP”) are approximately 20-200 nanometers in size and are currently the smallest known self-replicating particles or bacteria. [0005] NB/CNP-induced calcification results from the formation of calcium-phosphate mineral deposits around each calcifying nano-particle. NB/CNPs secrete a protective calcific biofilm (i.e., a lipopolysaccharide (LPS) endotoxin biofilm) that also allows multiple NB/CNP to connect, collaborate and apparently form “colonies.” This calcific biofilm also allows the NB/CNP to expand, contract and move. The biofilm appears to be generated as part of a stress response mechanism; it is primarily observed, for example, when NB/CNP are chemically, physiologically or environmentally attacked, when they are working together and/or during NB/CNP reproduction. The biofilm that is secreted by the NB/CNP is a potent endotoxin and activates a thrombic cascade causing inflammation, swelling and the release of cytokines, interleukins, leukocytes, mast cells, collagenase, matrix metalloproteinases and other immune-response events in surrounding cells. [0006] NB/CNP are “extremeophiles” (i.e., highly tolerant to heat, freezing, dehydration and Gamma Irradiation) and are apparently more resistant than most bacteria to destruction. Thus, NB/CNPs have been found to be residual contaminants on otherwise sterilized medical products such as tissue, blood and bovine serum. Similarly, NB/CNP cannot be killed using most antibiotics, including, for example, Penicillin, Cephalosporins, or Macrolides. It has been observed, however, that NB/CNP are sensitive to in vitro treatment with certain tetracycline's and that EDTA can assist in dissolving the protective biofilm secreted by NB/CNP. [0007] Bench and clinical research have established that atherosclerosis is an inflammatory disease characterized by injury or infection of the vascular endothelium resulting in the formation of atheromas and pathological calcification. Inflammatory cascade responses within individual atheromas (as the immune system attempts to “wall off” or isolate an area of injury) result in the synthesis of a fibro-lipid matrix synthesis and the degradation/absorption of soft plaques. The rate of plaque synthesis-resorption is dependent upon the degree and/or stage of inflammatory activity within atheroma. Mature atheromas, for example, contain pathological calcification deposits that have been observed to increase at an annual rate of 24-82%. [0008] Although pathological calcification deposits are a hallmark of atherosclerosis, the precise mechanism of such calcium precipitation has remained elusive. It has been widely speculated, however, that NB/CNP play a critical role in the pathological calcification processes associated with atherosclerosis. In particular, NB/CNP have been detected in atherosclerotic plaques, calcified carotid arteries, aortic aneurysms and cardiac valves. Furthermore, NB/CNP particles morphologically and functionally resemble the calcifiable vesicles, are capable of active calcium phosphate precipitation under suitable nutrient conditions and have previously been isolated from atherosclerotic aorta [0009] Accordingly, there is a need for a specialized treatment comprising appropriate combinations of compositions of at least one of tetracycline, EDTA, and other materials for the treatment of NB/CNP-based atherosclerotic disease. A further objective of the invention is to identify a treatment protocol that is effective for treatment of atherosclerotic disease and which includes in vitro treatment with tetracycline, EDTA and other materials. SUMMARY OF THE INVENTION [0010] The invention provides therapeutic methods and compositions for the treatment of calcification and/or plaque-based conditions associated with nanobacteria/calcifying nano-particle infection and in particular, atherosclerotic disease. Such therapeutic methods and compositions include administering a combination of a nutraceutical powder, tetracycline HCl and ethylenediaminetetraacetic acid disodium salt (EDTA-sequestrant). [0011] Thus, one aspect of the invention is to provide compositions for the treatment of a disease characterized by calcification and/or plaque formation, or for the treatment of pathological calcification caused by Nanobacteria Calcifying Nano-Particles comprising at least one of a nutraceutical supplement, an antibiotic, and a metal chelator. [0012] In accordance with the invention, the nutraceutical supplement may be comprised of a mixture of one ore more of Niacin, Vitamin B6, Folate, Vitamin C, Selenium, L-Arginine, L-Ornithine, L-Lysine, Bromelain, Trypsin, Papain, Co-Q10, Grapeseed Extract, Hawthorne Berry, Vitamin A, Vitamine E, Vitamin B1, Vitamin B2, Vitamin B12, Magnesium Citrate, Methyl Sulfonyl Methane, Curcuma Longa , Quercitin, Pycnogenol, Gugulipid. [0013] In accordance with the invention, the antibiotic may be comprised of at least one of tetracycline, tetracycline HCL, Chlortetracycline, Democlocycline, Doxycycline, Methacycline, Oxytetracycline, Rolitetracycline, Minocycline, Sancycline, or salts thereof. [0014] In accordance with the invention, the metal chelator may be comprised of at least one or more of Ethylenediaminetetraacetic acid (EDTA), Ethyleneglycoltetraacetic acid (EGTA), Diethylenetriaminepentaacetate (DTPA), Hydroxyethylethylenediaminetriacetic acid (HEEDTA), Diaminocyclohexanetetraacetic acid (CDTA), 1,2-Bis(2-aminophenoxy)ethane-N,N,N′,N′-tetraacetic acid (BAPTA), and pharmaceutically acceptable salts thereof. [0015] In yet another aspect, the present invention relates to a method of using a composition comprising calcium chelators, bisphosphonates and/or citrate compounds which comprises administering said composition to reduce and/or prevent calcification related diseases, such as heart or circulatory diseases such as Arteriosclerosis, Atherosclerosis, Coronary Heart Disease, Chronic Heart Failure, Valve Calcifications, Arterial Aneurysms, Calcific Aortic Stenosis, Transient Cerebral Ischemia, Stroke, Peripheral Vascular Disease, Monckeberg's Disease, Vascular Thrombosis; Dental Diseases such as Dental Plaque, Gum Disease (dental pulp stones), calcification of the dentinal papilla, and Salivary Gland Stones; Chronic Infection Syndromes such as Chronic Fatigue Syndrome; Kidney and Bladder Stones, Gall Stones, Pancreas and Bowel Diseases such as Pancreatic Duct Stones, Crohn's Disease, Colitis Ulcerosa; Blood disorders; Adrenal Calcification; Liver Diseases such as Liver Cirrhosis and Liver Cysts; Testicular Microliths, Chronic Calculous Prostatitis, Prostate Calcification, Calcification in Hemodialysis Patients, Malacoplakia; Autoimmune Diseases such as Lupus Erythematosous, Schleroderma, Dermatomyositis, Cutaneous polyarteritis, Panniculitis (Septal and Lobular), Antiphospholipid Syndrome, Arteritis Nodosa, Thrombocytopenia, Hemolytic Anemia, Myelitis, Livedo Reticularis, Chorea, Migraine, Junvenile Dermatomyositis, Graves Disease, Chronic Thyroiditis, Hypothyreoidism, Type 1 Diabetes Mellitis, Addison's Disease, and Hypopituitarism; Placental and Fetal Disorders, Polycystic Kidney Disease, Glomerulopathies; Eye Diseases such as Corneal Calcifications, Cataracts, Keratopathy, Macular Degeneration and Retinal Vasculature-derived Processes and other Retinal Degenerations; Retinal Nerve Degeneration, Retinitis, and Iritis; Ear Diseases such as Otosclerosis, Degeneration of Otoliths and Symptoms from the Vestibular Organ and Inner Ear (Vertigo and Tinnitus); Thyroglossal cysts, Thyroid Cysts, Ovarian Cysts; Cancer such as Meningiomas, Breast Cancer, Prostate Cancer, Thyroid Cancer, Serous Ovarian Adenocarcinoma; Skin diseases such as Pyoderma gangrenosum, Dermatomyositis, eccrine sweat duct calcification, trichoepithelioma, pilomatrixoma, necrobiosis lipoidica, Calcinosis Cutis, Skin Stones, Calciphylaxis, Psoriasis, Eczema, Lichen Ruber Planus or Lichen Simple Cysts; Choroid Plexus Calcification, Neuronal Calcification, Calcification of the Falx Cerebri, Calcification of the Intervertebral Cartilage or Disc, Intercranial or Cerebral Calcification, Rheumatoid Arthritis, Calcific Tenditis, Oseoarthritis, Fibromyalgia, Bone Spurs, Diffuse Interstitial Skeletal Hyperostosis, Intracranial Calcifications such as Degenerative Disease Processes and Dementia; Erythrocyte-Related Diseases involving Anemia, Intraerythrocytic Nanobacterial Infection and Splenci Calcifications; Chronic Obstructive Pulmonary Disease, Broncholiths, Bronchial Stones, Neuropathy, Calcifications and Encrustations of Implants, Mixed Calcified Biofilms, and Myelodegenerative Disorders such as Multiple Sclerosis, Lou Gehrig's, and Alzheimer's Disease in an individual in need thereof. [0016] Yet another aspect of this invention is to provide methods for administering a pharmaceutically or therapeutically effective amount of a composition of the invention to a human or mammal. DETAILED DESCRIPTION OF THE INVENTION [0017] This application incorporates herein by reference in its entirety the copending and commonly assigned U.S. Non-provisional patent application Ser. No. 10/891,483 entitled “Methods and Compositions for the treatment of Diseases Characterized by Pathological Calcification” (Attorney Docket No. 19772-0004) which was filed with the United States Patent and Trademark Office on Jul. 15, 2004. [0018] As discussed above, nanobacteria/calcifying nano-particle (“NB/CNP”) cause pathological calcification associated with a number of conditions, including atherosclerotic disease. Thus, an objective of the invention is to provide compositions useful in countering such NB/CNP-associated pathological calcification. Similarly, another objective of the invention is to provide a protocol for administering such compositions for the treatment of atherosclerotic diseases. [0019] The invention provides therapeutic methods and compositions for the treatment of calcification and/or plaque-based conditions associated with NB/CNP infection and atherosclerotic disease. In particular, the invention includes compositions and therapeutic protocols for administering such compositions that include a nutraceutical powder, certain tetracyclines and ethylenediaminetetraacetic acid calcium disodium salt (EDTA-sequestrant). The combination of these ingredients also offers novel compositions that may be useful in the treatment of other NB/CNP related/pathological calcification conditions, including but not limited to, for example, heart or circulatory diseases such as Arteriosclerosis, Atherosclerosis, Coronary Heart Disease, Chronic Heart Failure, Valve Calcifications, Arterial Aneurysms, Calcific Aortic Stenosis, Transient Cerebral Ischemia, Stroke, Peripheral Vascular Disease, Monckeberg's Disease, Vascular Thrombosis; Dental Diseases such as Dental Plaque, Gum Disease (dental pulp stones), calcification of the dentinal papilla, and Salivary Gland Stones; Chronic Infection Syndromes such as Chronic Fatigue Syndrome; Kidney and Bladder Stones, Gall Stones, Pancreas and Bowel Diseases such as Pancreatic Duct Stones, Crohn's Disease, Colitis Ulcerosa; Blood disorders; Adrenal Calcification; Liver Diseases such as Liver Cirrhosis and Liver Cysts; Testicular Microliths, Chronic Calculous Prostatitis, Prostate Calcification, Calcification in Hemodialysis Patients, Malacoplakia; Autoimmune Diseases such as Lupus Erythematosous, Schleroderma, Dermatomyositis, Cutaneous polyarteritis, Panniculitis (Septal and Lobular), Antiphospholipid Syndrome, Arteritis Nodosa, Thrombocytopenia, Hemolytic Anemia, Myelitis, Livedo Reticularis, Chorea, Migraine, Junvenile Dermatomyositis, Graves Disease, Chronic Thyroiditis, Hypothyreoidism, Type 1 Diabetes Mellitis, Addison's Disease, and Hypopituitarism; Placental and Fetal Disorders, Polycystic Kidney Disease, Glomerulopathies; Eye Diseases such as Corneal Calcifications, Cataracts, Macular Degeneration and Retinal Vasculature-derived Processes and other Retinal Degenerations; Retinal Nerve Degeneration, Retinitis, and Iritis; Ear Diseases such as Otosclerosis, Degeneration of Otoliths and Symptoms from the Vestibular Organ and Inner Ear (Vertigo and Tinnitus); Thyroglossal cysts, Thyroid Cysts, Ovarian Cysts; Cancer such as Meningiomas, Breast Cancer, Prostate Cancer, Thyroid Cancer, Serous Ovarian Adenocarcinoma; Skin diseases such as Calcinosis Cutis, Skin Stones, Calciphylaxis, Psoriasis, Eczema, Lichen Ruber Planus or Lichen Simple Cysts; Choroid Plexus Calcification, Neuronal Calcification, Calcification of the Falx Cerebri, Calcification of the Intervertebral Cartilage or Disc, Intercranial or Cerebral Calcification, Rheumatoid Arthritis, Calcific Tenditis, Oseoarthritis, Fibromyalgia, Bone Spurs, Diffuse Interstitial Skeletal Hyperostosis, Intracranial Calcifications such as Degenerative Disease Processes and Dementia; Erythrocyte-Related Diseases involving Anemia, Intraerythrocytic Nanobacterial Infection and Splenci Calcifications; Chronic Obstructive Pulmonary Disease, Broncholiths, Bronchial Stones, Neuropathy, Calcifications and Encrustations of Implants, Mixed Calcified Biofilms, and Myelodegenerative Disorders such as Multiple Sclerosis, Lou Gehrig's, and Alzheimer's Disease. [0020] The nutraceutical powder includes Vitamin C, Vitamin B6, Niacin, Folic Acid, Selenium, EDTA, L-Arginine, L-Lysine, L-Ornithine, Bromelain, Trypsin, Niacin, CoQ10, Grapeseed Extract, Hawthorn Berry and Papain. The nutraceutical powder can also include other ingredients and materials as described below. The quantity of each component of the nutraceutical powder as well as the quantity of nutraceutical powder used in the invention may be varied for different patients and/or treatment conditions. For instance, the addition of other vitamins such as, but not limited to, Vitamin A as β Carotene, Vitamin E as d-alpha Tocopherol Succinate, Vitamin B 1 as thiamine mononitrate, Vitamin B2 as riboflavin, and Vitamin B 12 as Cyanocobalamin. Other ingredients such as Methyl Sulfonyl Methane, Magnesium Citrate, Zinc Citrate, and herbal extracts such as Mahonia aquifolium, Curcuma Longa , Quercetin, picnogenol, gugulipid, Schizandra chinensis, Licorice root, Alfalfa seed, wheatgrass, green barley grass, Chorella algae, Spirulina , Flaxseed, milk thistle, and/or Aslanguanda may be added, Other enzymes and or amino acids may also be added to the formulation such as, but not limited to, Lipase, Protease, Peptase, Serrapeptase, Cellulase, L-Glutathione. [0021] Suitable tetracycline's include, but are not limited to, tetracycline, tetracycline HCl, chlortetracycline, demeclocycline, doxycycline, methacycline, oxytetracycline, rolitetracycline, minocycline, sancycline and pharmaceutically acceptable salts thereof. A preferred tetracycline is tetracycline HCl. The dose of these medicines may be varied for different patients and/or treatment conditions. [0022] Suitable chelating agents include, but are not limited to one or more of Ethylenediaminetetraacetic acid (EDTA), Ethyleneglycoltetraacetic acid (EGTA), Diethylenetriaminepentaacetate (DTPA), Hydroxyethylethylenediaminetriacetic acid (HEEDTA), Diaminocyclohexanetetraacetic acid (CDTA), 1,2-Bis(2-aminophenoxy)ethane-N,N,N′,N′-tetraacetic acid (BAPTA), and pharmaceutically acceptable salts thereof. [0023] One hundred patients with stable coronary artery disease (“CAD”) and positive coronary artery calcium (“CAC”) scores were initially enrolled in a four month treatment regimen that included daily administration of a three-component composition composed of the nutraceutical powder (discussed above), tetracycline HCl and ethylenediaminetetraacetic acid calcium disodium salt (EDTA-sequestrant). Exclusion criteria included: (1) known tetracycline allergy, (2) zero CAC score, (3) recent (<30 days) major adverse cardiac event, (4) women of childbearing age, (5) recent diagnosis of thyroid or parathyroid disease, (6) clinically significant renal insufficiency or liver function abnormalities and (7) recent (<30 days) acute congestive heart failure. CAC scoring was repeated at four months and serum samples were analyzed for NB/CNP antigen and baseline serology at zero, two and four months. Complete blood count, metabolic panel, liver function, C-reactive protein (hs-CRP) and lipids were analyzed at zero and four months. Other than discontinuing any herbal or vitamin preparation, patients maintained their normal medical regime during the study. Baseline History and Physical examination were performed. The same CAC scoring machine was used for each individual patient to assess initial and final CAC scores. CAC scoring radiologists were experienced in CAC scoring and were blinded to patient identity. CAC scoring was repeated after four months of treatments. Before completion of the study, one patient withdrew secondary to a presumed sensitivity to tetracycline HCL and twenty-two patients were withdrawn due to noncompliance. [0024] As discussed in more detail below in conjunction with the accompanying Tables, 100% of the seventy-seven patients completing the study were positive for NB/CNP serology, antigen or both. Responders (n=44; 57%) had significant decreases in total CAC scores (p=0.001); the average decrease being 14%. Non-responders (n=33; 44%) had no change or had increases in CAC scores. No adverse physiologic effects were seen in the renal, hepatic, or hematopoetic systems of the treated patients. Angina was decreased or ablated in 16 of 19 patients (84%). Lipid profiles significantly improved in the non-atherogenic direction (p=0.001). Such a change in the lipid profiles is significant given that 86% of the patient group were on continuous statin medication prior to treatment. [0025] In the accompanying Tables, data is presented as frequency and percentage distributions. Values for continuous variables are expressed as mean plus or minus a (“±”) standard deviation. Within group comparisons of initial and ending CAC scores (mean) and laboratory values were conducted using a paired t-test. Between group comparisons of continuous variables were conducted with the Student's t-test. Univariate analysis of selected discrete variables was accomplished by X 2 , the continuity X 2 analysis or a two-tailed Fischer Exact test with the appropriate degrees of freedom. Statistical procedures were performed using the Number Cruncher Statistical Systems® (NCSS, Kaysville, Utah). Ap-value of less than or equal to 0.05 was designated as statistically significant in the treatment study. [0026] Tables 1 and 2 provide statistical data and physical characteristics of participants in a study evaluating the clinical effects of the invention. In Table 1, the initial physical and clinical characteristics of the final study participants (n=77) are described. In Table 2, the seventy-seven participants are subdivided into “responder” and “nonresponder” groups (as defined below) based on their response to treatment with the invention. Table 2 further illustrates the pretreatment physical characteristics for both the “responder” and “nonresponder” groups. The data in Table 2 indicates that both groups had comparable pre-treatment clinical variables and risk factors. [0027] Table 3 demonstrates that 44 (57%) of the seventy-seven patients responded to treatment with the invention as evidenced by a decrease in total CAC score. The remaining 33 patients (43%) were considered “nonresponders” based solely on their CAC score. As can be seen in Table 3, total CAC scores decreased significantly (p=0.001) from the beginning to the end of the study for the responder group. Significant reduction in both the left anterior descending coronary artery and the right coronary artery CAC scores were also documented p=0.002). There was no significant difference found in the left main coronary artery (p=0.972) or circumflex coronary artery CAC scores (p=0.106). [0028] Table 4 illustrates that all responder group patients tested positive for the presence of anti-NB/CNP IgG antibodies prior to the commencement of therapy. During treatment with the invention, NB/CNP antigen and serology titers tended to fluctuate (although the fluctuations were not statistically significant) in all patients independent of changes in CAC scores or stage of therapy. [0029] Table 5 demonstrates the beneficial changes in the lipid profiles for responder group patients following treatment with the invention. Notably, it was observed that responder group patients experienced reduced total cholesterol levels (p=0.001), reduced triglycerides p=0.006), decreased LDL (p=0.001) and increased HDL (p=0.001) following treatment with the invention. [0030] In addition to the favorable results illustrated in Tables 1-5, other data supports the efficacy of the invention. For example, prior to treatment, 19 patients (25%) had stable angina pectoris. Following four months of treatment, the angina symptoms had been either eliminated or substantially ameliorated in 16 of the 19 (84%) patients (p=0.013). Similarly, two patients (3%) with severe claudication and faint pedal pulses reported a diminution of claudication symptoms and the return of their peripheral pulses to normal values following treatment. [0031] The foregoing data demonstrates that administration of a combination of a nutraceutical powder, certain antibiotics and EDTA for sustained periods is effective for treating CAD patients. Specifically, every second CAD patient treated as described herein demonstrated an objective improvement in their cardiac vasculature performance and had appreciably decreased CAC scores (avg. ˜14% decrease). These results are particularly encouraging considering that CAC scores are known to increase by more than 20% annually. These results highlight the significance of the invention given that there have been no previous reports showing a significant decrease in CAC scores pursuant to any known means of intervention. [0032] Furthermore, based on the foregoing data (for both the responder and nonresponder patient groups), it is possible to infer that other variables, including, for example, treatment time, plaque density/volume, tissue penetration and blood supply may be critical factors that influence overall outcomes related to treatment efficacy. Based on these findings, it appears that CAC scores would continue to decrease in conjunction over longer periods of therapy (i.e., plaque regression over time). Additionally, the treatment regimen did not produce any apparent or significant adverse physiological effects on the study participants. EXAMPLES [0033] The invention is further illustrated by the following examples. All scientific and technical terms have the meanings as understood by one with ordinary skill in the art. The specific examples that follow illustrate the methods in which the compositions of the present invention may be prepared and/or protocols for the administration of such compositions to a patient in need thereof. Such examples, however, are merely illustrative and are not intended nor should be construed as limiting the invention in sphere or scope. The methods may be adapted and/or varied in order to produce compositions embraced by this invention but not specifically disclosed. Further, variations of the methods to produce the same compositions in somewhat different fashion will be evident to one skilled in the art. [0000] 1. Formulations [0034] In one embodiment of the invention, a composition for treatment of atherosclerotic diseases associated with NB/CNP infection that includes at least three components is disclosed. These components include a quantity of a nutraceutical powder (that includes Vitamin C, Vitamin B6, Niacin, Folic Acid, Selenium, EDTA, L-Arginine, L-Lysine, L-Ornithine, Bromelain, Trypsin, Niacin, CoQ10, Grapeseed Extract, Hawthorn Berry and Papain), a quantity of a tetracycline compound and a quantity of ethylenediaminetetraacetic acid disodium salt or calcium di-sodium salt (EDTA-sequestrant). [0035] In another embodiement, the nutraceutical powder may also include other Vitamins such as, but not limited to, Vitamin A, Vitamin E, Vitamin B1, B2, and B12. Materials such as methyl sulfonyl methane (MSM), Citrates such as Magnesium Citrate or Zinc Citrate and herbal extracts such as Mahonia aquifolium, Curcuma longa (turmeric), Lipase, Protease, Peptase, Serrapeptase, Cellulase, L-Glutathione, Schizandra Chinensis , Licorice Root, Quercetin, Alfalfa Seed, Wheatgrass, Green Barley Grass, Chlorella Algae, Spirulina , Flaxseed, Milk Thistle, picnogenol, Gugulipid, Aslaguanda may also be added to the formulae as predicated by specific patient requirements. [0036] In another embodiment, the quantity of the nutraceutical powder component is mixed with water, juice (e.g., apple or orange juice) or other suitable liquid prior to being administered. [0037] In another embodiment, the quantity of the nutraceutical powder component is 5 cm 3 and is mixed with water, juice (e.g., apple or orange juice) or other suitable liquid prior to being administered. [0038] In other embodiments, the quantity of nutraceutical powder is formulated as either a pill or capsule. [0039] In another embodiment the tetracycline compound is tetracycline HCl. [0040] In another embodiment, 500 mg of the tetracycline HCl component is formulated as a capsule before being administered. [0041] In another embodiment, 500 mg of the tetracycline HCl component is formulated as a pill before being administered. [0042] In another embodiment, 1500 mg of the ethylenediaminetetraacetic acid calcium disodium salt (EDTA-sequestrant) component is formulated as a suppository before being administered. [0043] As will be appreciated by those knowledgeable in the art, the therapeutic components of the invention may be individually or collectively formulated in different manners, quantities and/or combinations and may otherwise be used in combination with other treatments. Furthermore, the therapeutic composition of the present invention may be packaged in any convenient, appropriate packaging. [0044] In addition to the specific component formulations recited in the above examples, each component of the invention may be in various other forms suitable for oral use (for example as tablets, lozenges, hard or soft capsules, aqueous or oily suspensions, emulsions, dispersible powders or granules, syrups or elixirs), for topical use (for example as creams, ointments, gels, or aqueous or oily solutions or suspensions) for administration by inhalation (for example as a finely divided powder or a liquid aerosol), for administration by insufflation (for example as a finely divided powder) or for parenteral administration (for example as a sterile aqueous or oily solution for intravenous, subcutaneous, or intramuscular dosing), or as a suppository for rectal dosing. [0045] Suitable pharmaceutically-acceptable excipients for a tablet formulation include, for example, inert diluents such as lactose, sodium carbonate, granulating and disintegrating agents such as corn starch or alginic acid; binding agents such as starch; lubricating agents such as stearate, stearic acid, fumed silica or talc; preservative agents such as ethyl or propyl p-hydroxybenzoate, and anti-oxidants, such as ascorbic acid or tocopherol acetate. Tablet formulations may be uncoated or coated either to modify their disintegration and the subsequent absorption of the active ingredient within the gastrointestinal tract, or to improve their stability and/or appearance, in either case, using conventional coating agents or fillers such as hydroxy propyl methyl cellulose (Methocel) or other cellulose and procedures well known in the art [0046] Compositions for oral use of one or more of the components may be in the form of hard gelatin capsules in which the active ingredient is mixed with an inert solid diluent, for example, calcium carbonate, calcium sulfate dihydrate, calcium phosphate or kaolin, or as soft gelatin capsules in which the active ingredient is mixed with water or an oil such as peanut oil, liquid paraffin, or olive oil. [0047] Aqueous suspensions of one or more of the components generally contain the active ingredient in finely powdered form together with one or more suspending agents, such as sodium carboxymethylcellulose, methylcellulose, hydroxyethyl starch, starch acetate, hydroxypropylmethylcellulose, sodium alginate, polyvinyl-pyrrolidone, gum tragacanth and gum acacia; dispersing or wetting agents such as lecithin or condensation products of an alkylene oxide with fatty acids (for example polyoxethylene stearate), or condensation products of ethylene oxide with long chain aliphatic alcohols, for example heptadecaethyleneoxycetanol, or condensation products of ethylene oxide with partial esters derived from fatty acids and a hexitol such as polyoxyethylene sorbitol monooleate, or condensation products of ethylene oxide with partial esters derived from fatty acids and hexitol anhydrides, for example polyethylene sorbitan monooleate. The aqueous suspensions may also contain one or more preservatives (such as ethyl or propyl p-hydroxybenzoate, anti-oxidants (such as ascorbic acid or tocopherol acetate), coloring agents, flavoring agents, and/or sweetening agents (such as sucrose, stevia, sucralose, xylitol, saccharine or aspartame). [0048] Oily suspensions of one or more of the components may be formulated by suspending the active ingredient in a vegetable oil (such as arachis oil, olive oil, sesame oil or coconut oil) or in a mineral oil (such as liquid paraffin). The oily suspensions may also contain a thickening agent such as beeswax, hard paraffin or cetyl alcohol. Sweetening agents such as those set out above, and flavoring agents may be added to provide a palatable oral preparation. These compositions may be preserved by the addition of an anti-oxidant such as ascorbic acid or tocopherol acetate. [0049] Dispersible powders and granules suitable for preparation of an aqueous suspension of one or more of the components by the addition of water (or other suitable liquid such as juice) generally contain the recited ingredient(s) together with a dispersing or wetting agent, suspending agent and one or more preservatives. Suitable dispersing or wetting agents and suspending agents are exemplified by those already mentioned above. Additional excipients such as sweetening, flavoring and coloring agents may also be present. [0050] One or more of the components of the invention may also be in the form of oil-in-water emulsions. The oily phase may be a vegetable oil, such as olive oil or arachis oil, or a mineral oil, such as for example liquid paraffin or a mixture of any of these. Suitable emulsifying agents may be, for example, naturally-occurring gums such as gum acacia or gum tragacanth, naturally-occurring phosphatides such as soya bean, lecithin, an esters or partial esters derived from fatty acids and hexitol anhydrides (for example sorbitan monooleate) and condensation products of the said partial esters with ethylene oxide such as polyoxyethylene sorbitan monooleate. The emulsions may also contain sweetening, flavoring and preservative agents. [0051] Syrups and elixirs of one or more of the components may be formulated with sweetening agents such as glycerol, propylene glycol, sorbitol, aspartame or sucrose, and may also contain a demulcent, preservative, flavoring and/or coloring agent. [0052] One or more of the components may also be in the form of a sterile injectable aqueous or oily suspension, which may be formulated according to known procedures using one or more of the appropriate dispersing or wetting agents and suspending agents, which have been mentioned above. A sterile injectable preparation may also be a sterile injectable solution or suspension in a non-toxic parenterally-acceptable diluent or solvent, for example a solution in 1,3-butanediol. [0053] Suppository formulations of one or more of the components may be prepared by mixing the active ingredient with a suitable non-irritating excipient which is solid at ordinary temperatures but liquid at the rectal temperature and will therefore melt in the rectum to release the drug. Suitable excipients include, for example, cocoa butter, polyethylene glycols and stearates. [0054] Compositions of one or more of the components for administration by insufflation may be in the form of a finely divided powder containing particles of average diameter of, for example, 30 μm or much less, the powder itself comprising either active ingredient alone or diluted with one or more physiologically acceptable carriers such as lactose. The powder for insufflation is then conveniently retained in a capsule containing, for example, 1 to 50 mg of active ingredient for use with a turbo-inhaler device, such as is used for insufflation of the known agent sodium cromoglycate. [0055] Compositions of one or more of the components for administration by inhalation may be in the form of a conventional pressurized aerosol arranged to dispense the active ingredient either as an aerosol containing finely divided solid or liquid droplets. Conventional aerosol propellants such as volatile fluorinated hydrocarbons or hydrocarbons may be used and the aerosol device is conveniently arranged to dispense a metered quantity of active ingredient. [0056] The amount of one or more of the ingredients comprising each component of the invention can be altered or combined with one or more excipients to produce a single dosage form and each such combination may vary depending upon the host treated and the particular route of administration. For example, a formulation intended for oral administration to humans may contain a component compounded with an appropriate and convenient amount of excipients that may vary from about 0.1 to about 99% by weight of the total composition. Such dosages may be obtained by mixing each component of the invention with different excipients (as recited above) such as agglutinants, disintegrators, lubricants, sliders or fillers. Other excipients include lactose, corn starch, saccharose, stearate, microcrystalline cellulose, sodium croscarmellose gelatin, cellulose acetophtalate, titanium dioxide, fumed and precipitated silicates, special talc for tablets and polyethylene glycol. [0000] 2. Treatment Protocols [0057] The invention further contemplates a protocol for administering the three-components of the invention for treatment of atherosclerotic diseases associated with NB/CNP infection. According to this aspect of the invention, there is provided a protocol for the separate and sequential administration of the nutraccutical powder (discussed above), tetracycline HCl and ethylenediaminetetraacetic acid disodium salt (EDTA-sequestrant) in sufficient quantity to an individual in need thereof. The protocol of the present invention can be administered to a patient by any available and effective delivery system including, but not limited to, oral, parenteral, transdermal, intranasal, sublingual, transmucosal, intra-arterial, or intradermal modes of administration in dosage unit formulations containing conventional nontoxic pharmaceutically acceptable carriers, adjuvants, and vehicles as desired, such as a depot or a controlled release formulation. [0058] In one embodiment of the treatment protocol, a patient is instructed, prior to going to bed, to mix approximately 5 cm 3 of the nutraceutical powder in water, juice (e.g., apple or orange juice) or other suitable liquid prior to being administered. Thereafter, the patient is instructed to orally consume the nutraceutical powder solution. In this embodiment, the patient is also instructed to orally consume approximately 500 mg of tetracycline HCl that had been formulated as a capsule before administration. Next, the patient is instructed to rectally insert approximately 1500 mg of ethylenediaminetetraacetic acid disodium salt (EDTA-sequestrant) that had been formulated as a suppository before administration. Once the three components of the composition were administered, the patient was instructed to lie down flat and fall asleep. [0059] Variations in the above treatment protocol can readily be made. In other embodiments, for example, the order in which the components are administered can be altered. Similarly, in differing embodiments, different quantities of each component may be employed and/or the components may individually or collectively formulated in different manners as warranted by prevailing conditions or patient needs. TABLE 1 Study Variables Variables Number Percentage Total Study 77 100 Number Gender Male 62 80.5 Female 15 19.5 Age Groups Under 50 4 5.2 (years) 50-59 25 32.5 60-69 25 32.5 70-79 20 26 80 and Over 3 3.9 Mean 63.2 ± 8.9 Range 42-81 Coronary Risk Hypertension 52 67.5 Factors Hyperlipidemia 68 88.3 Diabetes Mellitus 20 26.0 Peripheral Vascular Disease 10 13.0 History of Congestive Heart 5 6.5 Renal Insufficiency 2 2.6 (Creatine > 2.0 mg/dL) Previous Myocardial Infarction 14 18.1 Stable Angina 19 24.7 Previous Prior Coronary Artery Bypass 39 50.7 Cardiovascular Grafting Prior Percutaneous Coronary 17 22.1 Intervention Current Statins 66 85.7 Medications Nitrates 23 29.9 Anticagulants 3 3.9 Beta Blockers 42 54.6 ACE Inhibitors 28 36.4 Diuretics 20 26.0 Antiplatelets 55 71.4 Calcium Blockers 12 15.6 ARB 18 23.4 [0060] TABLE 2 Comparison of Pretreatment Clinical Variables and Risk Factors of Study Population by Patient Group Responders NonResponders Variables Number/(Percentage) Number/(Percentage) p Value Total Study 44 (100) 33 (100) Number Gender Male 37 (84.1) 25 (75.8) 0.361 Female 7 (15.9) 8 (24.2) Age/Groups Mean 64.9 ± 8.9 61.0 ± 8.4 0.058 Range 48-81 42-80 Under 50 2 (4.5) 2 (6.1) 50-59 12 (27.3) 13 (39.4) 60-69 14 (31.8) 11 (33.3) 70-79 14 (31.8) 6 (18.2) 80 and Over 2 (4.5) 1 (3.0) Coronary Risk Hypertension 31 (70.5) 21 (63.6) 0.527 Factors Hyperlipidemia 41 (93.2) 27 (81.8) 0.160 Diabetes Mellitus 11 (25.0) 9 (27.3) 0.822 Peripheral Vascular 4 (9.1) 6 (18.2) 0.311 Disease History of Congestive 3 (6.8) 2 (6.1) 0.999 Heart Failure Renal Insufficiency 1 (2.3) 1 (3.0) 0.999 (Creatine > 2.0 Previous Myocardial 10 (22.8) 4 (12.1) 0.370 Stable Angina 16 (36.4) 3 (9.1) 0.013 Previous Prior Coronary Artery 24 (54.5) 15 (45.5) 0.430 Cardiovascular Bypass Grafting Intervention Prior Percutaneous 10 (22.7) 7 (9.1) 0.999 Coronary Intervention Current Statins 39 (88.6) 27 (81.8) 0.515 Medications Nitrates 16 (36.4) 7 (21.2) 0.151 Anticagulants 2 (4.5) 1 (3.0) 0.999 Beta Blockers 27 (61.4) 15 (45.5) 0.165 ACE Inhibitors 15 (34.1) 13 (39.4) 0.632 Diuretics 12 (27.3) 8 (24.2) 0.764 Antiplatelets 32 (72.7) 23 (69.7) 0.771 Calcium Blockers 5 (11.4) 7 (21.2) 0.238 ARB 8 (18.2) 10 (30.3) 0.214 [0061] TABLE 3 Comparison of Initial and Ending CAC Scan Scores for Responders Variables Initial Score Ending Score p Value Total Responder Number 44 (100) 44 (100) Total Score 2033.0 1753.8 0.001 Left Coronary Artery 89.5 89.8 0.972 Left Anterior 927.7 788.4 0.002 Descending Coronary Artery Circumflex Coronary 244.2 211.1 0.106 Artery Right Coronary Artery 771.0 664.5 0.002 [0062] TABLE 4 Comparison of Responder NB/CNP Antibody Levels (Units) and Antigen Levels (Units) Beginning Two-Month Value Value EndingValue Variables (Mean ± S.D.) (Mean ± S.D.) (Mean ± S.D.) p Value NB/CNP 0.864 ± 0.35 0.954 ± 0.485 0.981 ± 0.50 Antibody Beginning Value v. 0.269 Two Month Value Beginning Value v. 0.300 Ending Value Two-Month Value v. 0.799 Ending Value NB/CNP 2.045 ± 4.64 2.067 ± 4.30  4.012 ± 8.39 Antigen Beginning Value v. 0.982 Two Month Value Beginning Value v. 0.206 Ending Value Two-Month Value v. 0.219 EndingValue [0063] TABLE 5 Comparison of Responders Beginning and Ending Cholesterol Levels Beginning Value EndingValue (Mean ± S.D.) (Mean ± S.D.) Lipid Panel (mmol/L) (mmol/L) p Value Total Cholesterol 4.9 ± 1.2 4.2 ± 0.88 0.001 Triglycerides 2.5 ± 3.2 1.9 ± 2.3 0.006 HDL Cholesterol 1.2 ± 0.319 1.4 ± 0.34 0.001 LDL Cholesterol 2.6 ± 0.9 2.1 ± 0.8 0.001 Beginning Value EndingValue (Mean ± S.D.) (Mean ± S.D.) Lipid Panel (mg/dL) (mg/dL) p Value Total Cholesterol 188.6 ± 47.4 164.5 ± 33.8 0.001 Triglycerides  232.0 ± 302.5  179.4 ± 221.1 0.006 HDL Cholesterol  47.4 ± 12.1 52.25 ± 13.0 0.001 LDL Cholesterol 101.8 ± 35.6  81.3 ± 29.5 0.001

The invention provides methods and compositions that include a nutraceutical supplement, antibiotic, and metal chelating agent that is administered to a patient to treat or prevent pathological calcification and or plaque formation as associated with Nanobacteria Calcifying Nano-Particles and/or diseases caused there-from, The method includes the administration of a therapeutically effective nutraceutical supplement, tetracycline HCL, and ethylenediaminetetraacetic acid calcium di-sodium salt to a patient in order to prevent and treat calcific disease.

BACKGROUND OF THE INVENTION The present invention relates to an arrangement for portioning viscous material, preferably foodstuff, e.g. ketchup or mustard, from a pack, preferably a plastic bag of flexible material, whereby a portioning means is connectable with the pack so that viscous material can be dispensed therefrom by means of said portioning means, preferably by gripping and compressing an elastic part thereof, whereby said portioning means includes a non-return valve having a valve seat and a valve means cooperating therewith and being adapted to prevent material from flowing back from the portioning means to the pack when said portioning means is compressed for dispensing material therefrom, and whereby the pack is positionable in an outer container so that the portioning means is directed downwards therefrom. Prior art outer containers of said type are expensive to manufacture and they do not permit quick exchange of empty packs for new such packs. Furthermore, simple retaining devices are lacking, which can be brought to quickly and easily retain the upper end of the portioning means relative to the outer container without the risk for loosening or damaging said portioning means when it is handled manually for dispensing material from the pack. The object of the present invention has been at first hand to eliminate these problems and this is arrived at by providing the device defined above. SUMMARY OF THE INVENTION By means of these characterizing features it is attained that the outer container as well as the retaining device consists of a few easily manufactured members. Furthermore, the measure to place a new pack in the outer container and locking the portioning means in relation thereto, is facilitated. The portioning means can namely be brought to automatically take an exact position relative to the retaining device when the pack is placed in the outer container such that said portioning means can be retained by means of the retaining device by simply closing the outer container. Additionally, the retaining device can protect vital members of the nonreturn valve forming part of the portioning means when said retaining device retains said portioning means such that said members are not damaged during manual handling of the portioning means for dispensing material from the pack. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 schematically illustrates all major components forming part of the arrangement according to the invention located beside each other before assembly thereof; FIG. 2 with a plan view illustrates an outer container forming part of the arrangement according to the invention and which is open and wherein a pack with a portioning means is located; FIG. 3 is a section along the line III--III through the arrangement of FIG. 2; FIG. 4 with a plan view illustrates the arrangement according to the invention, whereby the outer container is closed; FIG. 5 is a vertical section through a portioning means forming part of the arrangement of the invention; FIG. 6 is the same section through the portioning means as in FIG. 5, but during suction of material; and FIG. 7 is the same section through the portioning means as in FIGS. 5 and 6, but during dispensing of material. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The portioning or dispensing device illustrated in the drawings is adapted for portioning or dispensing viscous materials 1, preferably foodstuff such as ketchup or mustard, from a pack 2, preferably a thinwalled plastic bag of flexible material. The pack 2 is positionable, e.g. suspendable at the top, in an outer container 3, which is suspendable or positionable at a location at which dispensing of the viscous material 1 occurs, e.g. in a kiosk, in a snack bar or in a restaurant. The portioning device has a portioning or dispensing means 4, preferably including a compressible hose 5 of elastic material. This portioning means 4 can be connected with the pack 2 so that viscous material 1 can be dispensed therefrom by means of the portioning means 4. The outer container 3 has down below a retaining device 6 for retaining the portioning means 4 at said container so that said portioning means is directed downwards from said outer container 3. The outer container 3 is divided into two container members 7, 8 along a plane P (see FIG. 4) extending between its lower and upper portions 9 and 10. The container members 7, 8 are movable relative to each other, preferably articulately connected with each other, in such a way that the outer container 3 can be opened and closed by changing their mutual positions. Furthermore, the retaining device 6 includes a retaining member 11 which is provided on one of the container members 7 and another retaining member 12 which is provided so that both retaining members 11, 12 together can be brought to retain the portioning means 4 at the outer container 3. Said other retaining member 12 is preferably mounted on the other container member 8, but can also be mounted on said first container member 7, e.g. as a movable clamp member, or being a separate member which can be positioned in another suitable way for retaining the portioning means 4 at the outer container 3. At least one of the container members 7 and/or 8 is preferably designed such that the pack 2 can be placed therein when the outer container 3 is open (see FIGS. 2 and 3, wherein the pack 2 is located in the container member 7). Hereby, a retaining portion 13 of the portioning means 4 is preferably positionable in the retaining member (here retaining member 11) of the same container member (here container member 7). As is apparent from the figures, one of the retaining members 11 can be mounted on one of the container members 7 and the other retaining member 12 mounted on the other container member 8 such that said retaining members 11, 12 are brought into retaining positions (see FIG. 4) to retain the portioning means 4 by bringing said container members 7, 8 into positions at which they define a closed outer container 3 and locking them in these positions relative to each other. For locking the container members 7, 8 relative to each other when said members define a closed outer container 3 and for locking also the retaining members 11, 12 relative to each other when these latter members retain the portioning means 4, a locking means 14, preferably a lock ring, can be provided, preferably threaded (see arrow A in FIG. 4) onto the retaining device 6 when the outer container 3 is closed. On the insert member 18 and preferably the mounting member 19 there may be provided a coupling device 15 which can be connected with the pack 2 for discharge of viscous material therefrom to the portioning means 4 before said pack 2 is encased in the outer container 3 and preferably before said pack 2 bas been placed (see arrows C, D in FIG. 1) in any of the container members 7 or 8. The compressible hose 5 has in one end a portioning or dispensing member 26 with a dispensing opening 16 and in another end an insert opening 17 through which an insert member 18 belonging to the portioning means 4 is insertable into the compressible hose 5 (see arrow B in FIG. 1). The coupling device 15 can be connected with the insert member 18 in such a way that one can connect said device with the pack 2 when the insert member 18 is provided in the portioning means 4 (see FIG. 1). Furthermore, the coupling device 15 is preferably a pipe piece provided on the mounting member 19 and of such length that is projects out from the insert opening 17 of the compressible hose 5 when the insert member 18 is provided in said compressible hose. Such a coupling device 15 can also be used for punching or making holes in the pack 2 when said device is connected. The mounting member 19 is preferably locatable in the portioning means 4 adjacent to the insert opening 17 thereof. This mounting member 19 may consist of a circular plate which is insertable into a circular mounting groove 20 preferably provided in the compressible hose 5, and which preferably is retained in said groove while those portions of the elastic material of the hose which are brought to deflect resiliently when the circular plate is inserted into the circular mounting groove 20, spring back or return to their original shape. A rod 21 may extend from central portions of the mounting member 19 and an end portion 22 of said rod defines a valve seat 23 for a portioning or dispensing valve 24 within the dispensing opening 16. The valve body 25 of the dispensing valve 24 may be formed by those parts of the dispensing member 26 which surround the end portion 22 of the rod 21. A material intake opening 27 can be provided in the mounting member 19 for permitting intake of viscous material from the pack 2 to the interior of the compressible hose 5. This material intake opening 27 can be located laterally offset relative to those central portions of the mounting member 19 from which the rod 21 extends. On the rod 21 adjacent to the mounting member 19 there may also be provided an valve means 28 of elastic material for a nonreturn valve 30. The mounting member 19 may define the valve seat 40 for the nonreturn valve 30 while the valve means 28 is provided to cooperate with the mounting member 19 around its material intake opening 27. The portioning means 4, and preferably its compressible hose 5, may at a retaining end 31 be provided with an annular mounting flange 32 and at least one of the retaining members 11 and/or 12 can be provided with a retaining groove 33 and/or 34 for retention of the annular mounting flange 32. Additionally, the mounting groove 20 can be provided in the annular mounting flange 32. The mounting member 19 preferably extends out to the outer portions of the mounting groove 20 and preferably is of such rigid material that it can form an inner support for the portioning means 4 within the retaining device 6 and at the same time prevent said portioning means 4 from being pulled downwards therefrom. At the container members 7, 8 of the outer container 3, a container member edge 35 which extends from a lower portion 9 to an upper portion 10 of one of the container members 7 and a container member edge 36 which extends from a lower portion 9 to an upper portion 10 of the other container member 8 may be connected with each other through a link device 37 which permits swinging together of said container members 7, 8 to define or form a closed or substantially closed outer container 3 (see FIG. 4) or apart to form an open outer container 3 (see FIG. 2). This link device 37 may include at least two rings 38, 39 of which each ring is threaded through a hole 38', 38' in one of the container members 7 and a hole 39', 39' in the other of said container members 8. One of the rings 38 preferably is provided at the lower portion 9 of the container members 7, 8 and the other ring 39 at the top or upper portion 10 of said members. Each container member 7, 8 and a retaining member 11, 12 provided thereon may be manufactured in one single piece and of the same material, e.g. plastic material. One container member 7 and the retaining member 11 provided thereon are identical or almost identical with the other container member 8 and the retaining member 12 provided thereon. As is apparent from the figures, each container member 7, 8 defines half or substantially half the outer container 3 and each retaining member 11, 12 defines half or substantially half the retaining device 6. Furthermore, each container member 7, 8 can be designed as an oblong and shape permanent shell, from the lower portion 9 of which a retaining member 11 and 12 respectively, projects as a half pipe piece or similar. It should also be mentioned that the pack 2 preferably has an inner coupling member 41 at which the coupling device 15 is insertable and which is adapted to retain said device. For dispensing material, material is initially fed into the portioning means 4 until said means is filled. Filling of the portioning means 4 occurs by gripping said means and "pumping" it by compressing or squeezing it and then release the grip. Since the portioning means 4 because of its elastic properties returns to its original shape (see arrows E in FIG. 6) when one releases the grip, a negative pressure is generated in said portioning means 4, whereby the nonreturn valve 30 is opened and material 1 is sucked from the pack 2 into the portioning means. This is repeated until the portioning means 4 is filled (see FIG. 6), whereby said portioning means is ready for portioning or dispense. By compressing the portioning means 4 (see arrows F in FIG. 7) filled as stated above, the nonreturn valve 30 will close and prevent material 1 from flowing back from said portioning means to the pack 2. Instead, the dispensing valve 24 is opened (by bringing the dispensing member 26 of the hose 5 to "gape" and thereby leave the valve seat 23 of the dispensing valve 24) and material 1 dispensed from the portioning means 4 (see FIG. 7). The arrangement illustrated in the drawings is handled so that when an empty pack 2 has been removed, the portioning means 4 is connected with a full pack 2 (see arrow C in FIG. 1). Thereafter, the pack 2 and the portioning means 4 connected therewith is placed in e.g. the container member 7 with the retaining portion 13 in its retaining position relative to the retaining member 11 (see FIG. 2). Then, the outer container 3 is closed, whereby the retaining portion 13 of the portioning means 4 will be located within the retaining device 6 and thus, at least also the valve seat 40 of the nonreturn valve 30. Hereby, the retaining device 6 will retain the retaining portion 13 relative to the outer container 3 and also protect the valve seat 40 of the nonreturn valve 30, i.e. in the embodiment shown, the mounting member 19 defining said valve seat 40. Since in the embodiment shown, the valve means 28 of the nonreturn valve 30 is also located within the retaining portion 13 and thereby will be surrounded by the retaining device 6, the valve means 28 is here also protected by said retaining device, which means that the entire nonreturn valve 30 can be protected by the retaining device 6 at least when said valve is closed. When the outer container 3 is closed and thus, the portioning means 4 is retained by the retaining device 6, the locking means 14 can be threaded onto said retaining device 6 through said portioning means 4, whereby the container members 7, 8 as well as the retaining members 11, 12 are locked in their closed positions. The outer container 3 is thus ready to be suspended or set up at its place of use with the portioning means 4 directed downwards. The material guiding members or portions of the portioning means 4 are easily cleaned after daily use by removing the insert member 18 from the hose 5, whereafter each such member or portion is washed separately. The washing of the insert member 18 can be facilitated if there is a gap (see FIG. 5) between the valve means 28 and the mounting member 19 for easy access between said members. When the cleaning is finished, it is easy to reassemble the members for further use in cleaned condition. The invention is not limited to the embodiment described above and illustrated in the drawings, but may vary within the scope of the following claims. As examples of alternative embodiments it can be mentioned that the container members 7, 8 can have another design than shown and they can eventually be entirely dismountable from each other instead of being articulately connected with each other, the retaining members 11, 12 of the retaining device 6 can be designed in other ways, e.g. can both members be located on the same container member, whereby one of the retaining members is movable so that it can be moved aside for positioning the portioning means 4 in the other and then moved back for locking said means to said other retaining member. One of the retaining members can also be completely removable from and securable to the other retaining member. Furthermore, the locking means 14 can be designed in other ways than shown for locking the retaining members 11, 12 in their retaining positions and there may alternatively be at least one locking means for locking the container members 7, 8 when the outer container 3 is closed, whereby said latter locking means indirectly also can lock the retaining members 11, 12. There may also be provided one or more locking means for locking the container members 7, 8 and one or more other locking means for locking also the retaining members 11, 12. The coupling device 15 can have other shapes and be mounted in other ways than shown--it may e.g. be a flexible hose which is connected with the mounting member 19 or with the portioning means 4 in other ways. This hose may at an outer end be provided with a connecting and/or lancing or punching pipe which can be connected with the pack 2. The portioning means 4 can also be of another design than described above and this is applicable also to the pack 2.

The present invention relates to an arrangement for portioning or dispensing viscous material from a pack, whereby the pack is positionable in an outer container and a portioning or dispensing unit includes a non-return valve which prevents the material from flowing back to the pack during portioning or dispensation. For being able to quickly place the pack in the outer container and quickly and safely lock a retaining portion as well as ensure than vital valve members of the non-return valve are not damaged during handling and operation of the portioning unit, the outer container is divided in a special way into two container members, whereby retaining members of the retaining device are integrated in the container members and whereby the valve seat of the non-return valve is surrounded by the retaining members of the retaining device.

PRIORITY CLAIM The present application is a Continuation of U.S. patent application Ser. No. 11/036,421 filed on Jan. 14, 2005; which is a Divisional of U.S. patent application Ser. No. 09/971,488 filed on Oct. 5, 2001 now U.S. Pat. No. 7,094,245, the entire disclosure of these applications are expressly incorporated herein by reference. FIELD OF THE INVENTION The present invention relates to compression clips, and more specifically, to compression clips used to cause hemostasis of blood vessels located along the gastrointestinal tract delivered to a target site through an endoscope. BACKGROUND Gastrointestinal (“GI”) bleeding is often associated with peptic ulcer disease (PUD) and can be fatal if not treated immediately. Hemorrhaging is the most dangerous procedure with which a Gastro-Intestinal Endoscopist has to deal. It is his/her only unplanned, emergency procedure where time is critical in determining the outcome. It is also the one problem the Endoscopist faces that is generally not an outpatient procedure. A bleeding PUD can be a critical clinical event as there is internal hemorrhaging. Ulcers are classified from clean to active spurting bleeding. The most worrisome are active bleeders and visible vessels. Untreated visible vessels are likely to bleed. Suspected bleeding PUD patients can be diagnosed and treated endoscopically in an emergency room, an ICU or the GI suite. Surgery generally results in higher cost, morbidity and mortality than endoscopy. Therefore, laparoscopy or open surgery is not preferred unless there is no endoscopic alternative or endoscopy has failed. If the diseased tissue is beyond repair, a surgical gastric resection may be performed. Currently, the endoscopist has two commonly used treatments and some lesser used therapies to achieve hemostasis of the ulcer. The most widely used treatments are thermal therapy and injection therapy. Some of the less common options are Olympus Endoclips, lasers and argon plasma cautery. With thermal therapy, a catheter with a rigid heating element tip is passed through the working channel of an endoscope after the bleed is visualized and diagnosed. After the rigid catheter tip has exited the scope, the scope is manipulated to press the tip against the bleed site. Thermal power is applied, either through a resistive element in the tip or by applying RF energy through the tissue, thus desiccating and cauterizing the tissue. The combination of the tip compressing the tissue/vessel and the application of heat theoretically welds the vessel closed. Although thermal treatment is fairly successful in achieving hemostasis, it often takes more than one attempt (irrigation is applied after the initial treatment to see if hemostasis has occurred) and there is frequent re-bleeding. Generally several pulses of energy are applied during each attempt. If early re-treatment is needed, there is a risk of perforation with the heat probe. Another disadvantage is that both types of thermal therapy require a specialized power generator and the equipment can be expensive. With injection therapy, a catheter with a distally extendable hypo needle is passed through the working channel of the endoscope after the bleeding has been visualized and diagnosed. Once the catheter tip has exited the scope, the scope is manipulated to the bleed site, the needle is extended remotely and inserted into the bleed site. A vasoconstricting (narrowing of blood vessels) or sclerosing (causing a hardening of tissue) drug is then injected through the needle. Multiple injections in and around the bleeding site are often needed, until hemostasis has been achieved. As with thermal therapy, re-bleeding is also a problem. The treatment used in any specific instance is highly dependent on geographic region. In some regions, especially in the United States, injection therapy is often combined with thermal treatment since neither therapy is completely effective alone. The primary success rate of endoscopic treatment is about 90%. The other cases are usually referred to surgery. All identified ulcers may re-bleed at a later time, but the re-bleed rate for endoscopically treated active bleeds and a visible vessel is 10-30%. Even with the introduction of new treatments and devices, these rates have not improved significantly in decades. Surgery's short and long-term success for permanent hemostasis is virtually 100%. Surgery has a higher success rate because the bleeding site is compressed mechanically, causing better hemostasis. Using devices such as clamps, clips, staples, sutures (i.e. devices able to apply sufficient constrictive forces to blood vessels so as to limit or interrupt blood flow), the bleeding vessel is ligated or the tissue around the bleed site is compressed, ligating all of the surrounding vessels. An existing device that incorporates the advantages of surgery into a less-invasive endoscopic procedure is the Olympus EndoClip. The goal of the device is to pinch the bleeding vessel to create hemostasis. The problem with this device is that once jaw closure begins, it is not possible to reopen them, and the endoscopist is committed to firing the clip. In other words, jaw closure is not reversible. Because the vessel is frequently difficult to see, often several clips must be deployed in order to successfully pinch the vessel and achieve hemostasis. Additionally, the Olympus EndoClip is a semi-reusable device, causing the performance of the device to degrade with use. SUMMARY OF THE INVENTION The present invention provides medical devices for causing the hemostasis of blood vessels located along the gastrointestinal tract. The goal of the invention is to give the endoscopist a technique and device which: 1) has a success rate in line with the surgical option; 2) is easier to set-up than the Olympus EndoClip; and 3) is easier to deploy than the Olympus EndoClip. The design intent is to eliminate surgery and its associated mortality and morbidity. The medical devices of the present invention include: a compression clip used to cause hemostasis of blood vessels and a mechanism for deploying the clip that includes an arrangement for closing the clip and for reversing the closing process to reopen the clip after closure has begun. Embodiments of the invention may include a lock arrangement for locking the clip closed; a control wire connected to the clip and able to be disconnected from the clip; an axially rigid sheath enclosing the control wire and communicating a compressive force opposing a tensile force of the control wire; a handle connected to the axially rigid sheath; and/or a trigger enclosed within the handle and engaging the control wire to close and lock the clip and to uncouple the control wire from the clip. There are several key advantages of the invention disclosed here over existing devices. The device's ability to repeatedly open and close the clip until the desired tissue pinching is accomplished will lead to a quicker procedure, requiring less clips to be deployed, with a higher success rate. In particular embodiments, this higher success rate will be improved even more due to the device's ability to be easily rotated so that the clip legs can be adjusted relative to the bleeding vessel. In particular embodiments, the time required to perform the overall procedure will also be further reduced due to the fact that the device is completely set up, with the clip already attached to the delivery device, unlike the competitive device. A more robust delivery device may allow a larger, stronger clip to be delivered. Combinations of these features will provide for a device that is easier to use. Another advantage inherent to particular embodiments of this design is the feature of being completely disposable. The competitive device, the Olympus Endoclip, uses a “semi-reusable” delivery device, capable of firing several clips before it fails. This causes the device's functionality to degrade over the course of its use, until it is no longer able to deploy a clip. The competitive delivery device must be loaded manually, which is cumbersome to the operator and time-consuming, especially in the context of an unplanned emergency procedure. The “single-use” (disposable) embodiments of the invention disclosed here would function the same with each clip, in each procedure. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an enlarged partial view of a first embodiment of the medical device of the present invention. FIG. 2 is an enlarged partial view of the distal end of the embodiment of FIG. 1 . FIG. 3 is an enlarged view of the clip of the embodiment of FIG. 1 . FIG. 4 is an enlarged view of the lock sleeve of the embodiment of FIG. 1 . FIG. 5 is an enlarged view of the j-hook of the embodiment of FIG. 1 . FIG. 6 is an enlarged partial view of the control wire, retainer, and clip of the embodiment of FIG. 1 . FIG. 7 is an enlarged partial view of the handle of the embodiment of FIG. 1 . FIG. 8A is an enlarged partial view of the distal end of another embodiment of the medical device of the present invention. FIG. 8B is an enlarged partial end view of the embodiment of FIG. 8A . FIG. 8C is an enlarged partial view of a clip leg of the embodiment of FIG. 8A . FIG. 8D is an enlarged partial view of a clip locking mechanism of the embodiment of FIG. 8A . FIG. 8E is an enlarged partial view of a clip locking mechanism and clip legs of the embodiment of FIG. 8A . FIG. 8F shows enlarged partial side views of various embodiments of clip leg shapes available for use in the medical device of the present invention. FIG. 8G shows enlarged partial end views of various embodiments of clip leg shapes available for use in the medical device of the present invention. FIG. 9A is an enlarged partial view of the distal end of another embodiment of the medical device of the present invention. FIG. 9B is an enlarged partial view of the embodiment of FIG. 9A being deployed. FIG. 10A is an enlarged partial view of another embodiment of the medical device of the present invention. FIG. 10B is an enlarged partial view of the embodiment of FIG. 10A being deployed. FIG. 11 is an enlarged partial view of another embodiment of the medical device of the present invention. FIG. 12A is an enlarged partial view of another embodiment of the medical device of the present invention showing the clip in an open position. FIG. 12B is an enlarged partial view of the embodiment of FIG. 12A showing the clip in a closed position. FIG. 13A is an enlarged partial view of another embodiment of the medical device of the present invention showing the clip in a closed position prior to disconnecting the clip. FIG. 13B is an enlarged partial view of the distal end of the embodiment of FIG. 13A showing the clip in a closed position after disconnecting the clip. FIG. 13C is an enlarged partial view of the embodiment of FIG. 13A showing the clip in a closed position after disconnecting the clip. FIG. 14A is an enlarged partial view of another embodiment of the medical device of the present invention. FIG. 14B is an enlarged partial side view of the embodiment of FIG. 14A . FIG. 14C is an enlarged partial view of the distal end of the medical device of the embodiment of FIG. 14A after the clip has been released. FIG. 15A is an enlarged partial view of another embodiment of the medical device of the present invention. FIG. 15B is an enlarged partial view of the clip of the embodiment of FIG. 15A in a closed position. FIG. 15C is an enlarged partial view of the clip of the embodiment of FIG. 15A in an open position. FIG. 15D is an enlarged partial view of the distal end of the medical device of the embodiment of FIG. 15A after the clip has been released. FIG. 16A is an enlarged partial view of another embodiment of the medical device of the present invention. FIG. 16B is an enlarged partial close-up side view of the end of a clip leg of the embodiment of FIG. 16A . FIG. 16C is an enlarged partial close-up edge view of the end of a clip leg of the embodiment of FIG. 16A . FIG. 16D is an enlarged partial view of the embodiment of FIG. 16A with the clip in an open position. FIG. 16E is an enlarged partial view of the embodiment of FIG. 16A with the clip in a closed position. FIG. 17A is an enlarged partial view of another embodiment of the medical device of the present invention. FIG. 17B is an enlarged partial view of the embodiment of FIG. 17A , showing the clip in an open position. FIG. 18A is an enlarged view of clip legs of another embodiment of the medical device of the present invention. FIG. 18B is an enlarged partial view of an embodiment of the medical device of the present invention using the clip legs of FIG. 18A . FIG. 18C is an enlarged partial view of the embodiment of FIG. 18B , showing the clip in a closed position. FIG. 18D is an enlarged edge view of the clip of the embodiment of FIG. 18B . FIG. 18E is an enlarged partial end view of the embodiment of FIG. 18B . FIG. 18F is an enlarged partial side view of the embodiment of FIG. 18B . FIG. 19A is an enlarged partial edge view of another embodiment of the medical device of the present invention. FIG. 19B is an enlarged partial side view of the embodiment of FIG. 19A . FIG. 19C is an enlarged partial view of a clip leg of the embodiment of FIG. 19A . FIG. 20A is an enlarged partial end view of another embodiment of the medical device of the present invention. FIG. 20B is an enlarged partial side view of the embodiment of FIG. 20A . FIG. 20C is a side-by-side comparison of two parts of the embodiment of FIG. 20A . FIG. 21 is an enlarged partial view of the distal end of another embodiment of the medical device of the present invention. DETAILED DESCRIPTION In a first embodiment of the invention as shown in FIG. 1 , medical device 100 includes a clip 101 having first clip leg 102 and second clip leg 103 . Clip leg 102 has at least one lock hole 104 therein of any suitable shape (e.g. circular, rectangular, square, etc.). Likewise, clip leg 103 has at least one lock hole 105 therein of any suitable shape. Clip 101 is further characterized by a cut-out 106 on the proximal end. J-hook 107 is inserted into cut-out 106 . J-hook 107 is formed on the distal terminal end of control wire 108 . A retainer release 109 is formed by bends in the control wire 108 , the bends formed proximally from the j-hook 107 . The control wire 108 is enclosed within sheath 111 proximally from the retainer release 109 . Retainer 110 is coupled to control wire 108 and engages lock sleeve 113 . Retainer release 109 acts to disengage retainer 110 from lock sleeve 113 when a tensile force applied to control wire 108 is sufficient to cause such disengagement. An outer sleeve 112 is connected on the distal side of sheath 111 , and lock sleeve 113 is connected to a distal side of outer sleeve 112 . Lock sleeve 113 incorporates lock pawl 114 , which engages lock hole 104 in clip leg 102 , and lock pawl 115 , which engages lock hole 105 in clip leg 103 . The clip 101 is a deformable, multi-legged, grasping device attached to the distal portion of a flexible shaft (the sheath 111 ) via a frangible link (the j-hook 107 ). The flexible shaft is connected at its proximal end to a handle ( FIG. 7 ), the handle analogous to biopsy forceps. A semi-rigid wire (the control wire 108 ), which is routed from the handle to the clip 101 , acts as a means of actuating the clip 101 between the open and closed position. The clip 101 can be actuated between the open and closed position multiple times as long as the lock holes 104 and 105 do not become engaged with the lock pawls 114 and 115 in the lock sleeve 113 . Once the operator decides the clip 101 should be permanently deployed, the handle can be fully actuated, which causes the retainer release 109 to pull the retainer 110 free from the outer sleeve 112 and lock sleeve 113 . After the retainer 110 is released, increasing force will begin straightening the j-hook 107 . The j-hook 107 is then pulled from the cut-out 106 on the proximal side of clip 101 . At this point, the retainer 110 and control wire 108 are no longer attached to the distal portion of the device (the clip 101 and lock sleeve 113 ) and the delivery device (e.g. an endoscope, not shown) can be removed while leaving the clip 101 (with lock sleeve 113 ) in place. The sheath 111 serves three key functions in this embodiment. In its primary function it acts as a housing for the control wire 108 . In this function the sheath 111 supplies a resistive, compressive force opposite the tensile force applied to the control wire 108 , via the handle, as the lever ( FIG. 7 ) in the handle is moved to close the clip 101 . The forces reverse when the lever is moved in the opposite direction, and the control wire 108 is compressed to push the clip 101 forward. In this function, the combination of control wire 108 and sheath 111 act as a simple push-pull, cable actuation mechanism. In the secondary function of sheath 111 , it acts as a means by which the clip 101 can be easily rotated. Ideally this rotation would be of a ratio of 1:1. In other words, one complete rotation of the sheath 111 at the proximal end would translate to one complete rotation of the clip 101 . This rotation however, depends on several factors. The relationship of the outside diameter of sheath 111 to the inside diameter of the working channel (not shown) of the endoscope (not shown), is one factor. Another factor is the amount of friction between the sheath 111 and the working channel caused by the path of the endoscope in the anatomy. Because these factors vary from endoscope to endoscope, and patient to patient, the rotation ratio will not always be the same. This ease of rotation is a key function and benefit of this embodiment in that it allows relatively precise orientation of the clip 101 to the vessel. Depending on the exact construction of the sheath 111 , and the other factors just listed, rotation of the device may be different in one direction of rotation versus the other direction. By taking advantage of the mechanical properties of the sheath 111 , this embodiment accomplishes rotation without the need for additional handle components. Eliminating the need for such components will: reduce the overall cost of the device; simplify how the device is operated; and make rotation more repeatable. In turn, all of these benefits will make for a faster procedure with a higher success rate. The sheath 111 accomplishes a high rotation ratio by using a spiral wound, multiple-wire, stainless steel, flexible shaft, with an outside diameter of slightly less than the inside diameter of the working channel of the endoscope. Because the sheath 111 is made of a multiple-wire configuration, it is soft and bendable, yet rigid in rotation. In other words, the sheath 111 is flexible enough to be manipulated through a flexible endoscope, but has a very low angle of twist about its central axis. In the third function of the sheath 111 , it acts as a component of the mechanism by which the clip 101 is released. The outer sleeve 112 , which is rigidly attached to the sheath 111 by methods known in the prior art (e.g. adhesives, welding, swaging, etc.), is made of a rigid tube, with two retainer cut-outs (not shown), situated 180° apart from each other. These retainer cut-outs house the two tabs 118 , 119 ( FIG. 6 ) of the retainer 110 . As the control wire 108 is actuated, drawing the clip 101 back into the lock sleeve 113 , the retainer release 109 forces the retainer 110 to be disengaged from the outer sleeve 112 . FIG. 2 shows the clip 101 in the closed position but prior to release of the j-hook 107 . In the closed, locked position shown in FIG. 2 , lock hole 104 of clip leg 102 is engaged by lock pawl 114 , and lock hole 105 of clip leg 103 is engaged by lock pawl 115 . The fit between the lock sleeve 113 and outer sleeve 112 is such that the lock sleeve 113 (and therefore the clip 101 ) will easily release from the outer sleeve 112 once the j-hook 107 has been straightened and the retainer disengaged from the outer sleeve 112 . The clip 101 , shown in FIG. 3 , is manufactured of a single piece of stainless steel, or any suitable biocompatible material, and is bent into a two-legged geometry. The clip legs 102 and 103 have a rectangular cross section of approximately 0.06 inches by 0.01 inches and are approximately 0.50 inches in length. The profile of the legs serves three purposes: first, the distal portion grasps the tissue during the procedure; second, the distal portion acts as the compression mechanism to hold the clip in place after deployment; and third, the profile between the distal grasping portion and the proximal end will interface with the lock pawls (not shown), via lock hole 104 in clip leg 102 and lock hole 105 in clip leg 103 . The interface between the lock holes and the lock pawls creates the mechanical lock that will keep the clip 101 closed after deployment. The proximal end of the clip 101 is formed with a cut-out 106 into which the j-hook ( FIG. 2 ) is attached. The lock sleeve 113 shown in FIG. 4 consists of a tubular proximal section, which fits into the distal end of the outer sleeve 112 . Retainer hole 116 and opposite retainer hole (not shown) in the lock sleeve 113 receive the retainer tabs 118 , 119 ( FIG. 6 ). The distal end of the lock sleeve 113 has a lock sleeve cut-out 117 slightly larger than the cross section of the clip legs ( FIG. 3 ). As the clip leg are pulled through cut-out 117 , the clip legs are compressed toward each other, thus compressing the tissue (not shown) situated between the clip legs. The cut-out 117 has lock pawls 114 and 115 , which align with the two lock holes ( FIG. 3 ) in the clip legs. After the desired tissue purchase has been acquired, the clip can be pulled back far enough to engage the lock pawls 114 and 115 into the two lock holes. Forming the end of the control wire 108 into a j-hook 107 makes a frangible link shown in FIG. 5 . This relatively simple configuration eliminates extraneous components that take up space and complicate the assembly. The control wire 108 is bent such that it wraps around the proximal end of the clip ( FIG. 3 ), through a cut-out ( FIG. 3 ). Another bend in the wire, proximal to the j-hook 107 , acts as a retainer release 109 . The retainer release 109 operates to release the retainer 110 ( FIG. 6 ) from the lock sleeve 113 ( FIG. 4 ). As the control wire 108 is actuated and the clip is locked into the lock sleeve, the retainer release 109 pulls the retainer 110 back, disengaging the retainer tabs 118 , 119 from the two retainer holes 116 ( FIG. 4 ) in which the retainer normally resides. After this disengagement is complete, the j-hook 107 is then straightened by force, in turn releasing the clip. The j-hook 107 is able to deform to a straightened position (i.e. release) at a predetermined tensile load, which is slightly greater than the load required to grasp the tissue (not shown), compress the tissue, and engage the lock pawls ( FIG. 4 ) in the lock holes ( FIG. 3 ). The control wire 108 shown in FIG. 6 is a simple stainless steel wire used to actuate the clip 101 via a handle ( FIG. 7 ), at the proximal end of the sheath ( FIG. 1 ). In this embodiment of the invention, the frangible link (the j-hook 107 ) is formed in the distal end of the control wire 108 as a one-piece design. The proximal end of the control wire 108 is terminated inside the handle. The control wire 108 also has the retainer release 109 formed in it, behind the j-hook 107 . The retainer release 109 causes the outer sleeve ( FIG. 1 ) to disengage from the retainer 110 . This is done sequentially, after the lock holes ( FIG. 3 ) in the clip 101 have engaged the lock sleeve ( FIG. 4 ). After the lock holes engage the lock sleeve, tensile force applied to control wire 108 first straightens j-hook 107 so that j-hook 107 releases from cut-out 106 , then retainer release 109 engages and deforms retainer 110 so that retainer tabs 118 and 119 disengage from the outer sleeve ( FIG. 1 ) and the lock sleeve ( FIG. 4 ). Alternatively, retainer release 109 could engage and deform retainer 110 before j-hook 106 straightens and disengages from cut-out 106 . The handle shown in FIG. 7 is attached to the proximal end of the sheath 111 at a sheath-handle attachment point 120 . The handle configuration is unlike a handle found on conventional endoscopic forceps known in the prior art. The handle provides a mechanism by which the amount of linear actuation required in the handle body 121 is greater than that which is translated to the tip of the device ( FIG. 1 ). In other words, actuation of the activator or handle lever 122 of 1.00 inch in turn may only move the clip ( FIG. 3 ) by 0.10 inch. This feature allows for a more tactile feel when placing the clip on the vessel (not shown). In effect, very subtle amounts of movement in the clip can be accomplished by more exaggerated, less precise movements of the operator's hand. This is accomplished because the activator or lever 122 pivots about a pivot point 123 that is close to the attachment point 124 of the control wire 125 . An alternative embodiment of the device may be made up of clips with more than two legs. FIGS. 8A through 8E show a clip with four legs. FIG. 8A shows a view from the side, showing clip legs 801 . This embodiment could be actuated and released in the same way the previous embodiment is activated and released, through a clip locking mechanism 802 . The use of a control wire (not shown) would actuate the multiple-legged clip in and out of an outer sleeve 803 until such time that the operator desires to release the clip. Alternatively, actuation of the control wire might move the outer sleeve 803 in and out over the multiple-legged clip to open and close the clip legs 801 , until such time that the operator desires to release the clip. FIG. 8B shows the four-legged clip of FIG. 8A from the perspective of the targeted tissue looking proximally. The four clip legs 801 are shown in an open position and are situated at 90° from each other. FIG. 8C shows a profile view of a single clip leg 801 . FIG. 8D shows a view along the axis of clip locking mechanism 802 . FIG. 8E shows another view of a four-legged clip with clip legs 801 and clip locking mechanism 802 . FIG. 8F shows alternative side profiles of the clip geometry. Use of such geometries in a clip with two or more legs allows for improved grasping ability in different situations. Given the large variation in tissue thickness and tissue strength, it is likely that different clip profiles would excel in different procedures. FIG. 8G shows alternative end profiles of the clip geometry. As with the varying side profiles, different end profiles would provide a broader range of grasping capabilities. FIGS. 9A and 9B illustrate an alternative embodiment of the device using a different method to lock the clip in the closed position. This alternative method uses an expanded coil spring 901 released over the outside of the clip legs 904 and 905 to lock the clip legs 904 and 905 closed. FIG. 9A shows this embodiment in a predeployment state. FIG. 9A shows a stretched coil spring 901 , twisted to a diameter larger than that of the relaxed state of coil spring 901 . Stretched coil spring 901 is placed over a rigid tube 903 at the distal end of the clip device. Within this rigid tube 903 , the clip legs 904 and 905 are free to move in and out (in a manner similar to the manner described for the previous embodiments), between the opened and closed position via a control wire (not shown). When the desired clip location has been achieved, the sheath 902 is used to push the coil spring 901 off of the rigid tube 903 , onto the clip legs 904 and 905 , as shown in FIG. 9B . The inward radial forces present in the recovered coil spring 901 act to keep the clip legs 904 and 905 compressed. FIGS. 10A and 10B illustrate another alternative embodiment. In this embodiment, a flexible linkage 1002 and pill 1003 are used to lock the clip legs 1001 . In this embodiment the clip legs 1001 are actuated via a control wire 1006 , as described in previous embodiments. However, in this embodiment, the clip legs are not closed by pulling the clip legs 1001 through some feature smaller than the open clip. Instead the clip legs 1001 are closed by drawing the two flexible links 1002 proximally, in the direction of the control wire 1006 , while a compressive force is applied to the base of the clip legs 1001 by a rigid sheath (not shown). This in turn pulls the legs of the clip toward each other. FIG. 10A shows the clip legs 1001 in an open position. FIG. 10B shows the clip legs in a closed position. The clip legs 1001 are locked in a closed position when the pill 1003 , located at the center of the flexible linkage 1002 , is drawn through a one way hole 1004 in the center of the clip legs 1001 . The one way hole 1004 is tapered, with a diameter slightly larger than the diameter of the pill 1003 on its distal side and a diameter smaller than the diameter of the pill 1003 on its proximal side. The pill stretches the material around the hole 1004 as it passes through moving proximally. Alternatively, the pill 1003 itself can be made of an elastic material and would deform slightly while passing proximally through hole 1004 . This funneling effect of the pill 1003 through the hole 1004 only allows the pill 1003 to easily pass through in the locking direction. This locking action is maintained after the clip is released by positioning the frangible link 1005 in a proximal direction on control wire 1006 from the pill 1003 , thus maintaining tissue compression. In this embodiment the frangible link 1005 is a taper in control wire 1006 , enabling the link to be broken at a specific position (proximal from the pill 1003 ) with a predetermined tensile load. One alternative to the j-hook type frangible link previously described is shown in FIG. 11 . This embodiment uses a threaded fitting that is a combination of a male thread 1103 and a female hub 1102 to attach the control wire (not shown) to the clip 1001 . The clip 1001 can be actuated from the opened position (not shown) to the closed position (shown) as described in previous embodiments. In this embodiment, the lock sleeve 1105 is shorter and engages dimples 1106 . After the lesion (not shown) is properly targeted, the clip 1101 can be released. The clip 1101 is released when a predetermined tensile load is applied to the male thread 1103 , in a similar fashion to the predetermined tensile load applied to straighten the j-hook. This force causes the male thread 1103 to detach from the female hub 1102 . The female hub 1102 may be constructed of a spiral wound wire component with a pitch equal to the thread pitch formed to make the male thread 1103 . The fit of the threaded components is such that the predetermined force will overcome the engaged threads of the male thread 1103 and the female hub 1102 , causing them to separate, or “strip” away from one another. Another alternative to the j-hook type frangible link is shown in FIGS. 12A and 12B . This embodiment uses a ball 1202 fitting into a socket, where the socket is defined by socket tabs 1203 , to attach the control wire 1207 to the clip 1201 . An outer sleeve 1204 is attached by way of a breakaway connection (not shown) to the sheath 1206 . This breakaway connection may be a light interference fit, or a light adhesive joint. The breakaway connection must be weak enough that when the sheath 1206 is pulled back through the working channel (not shown) of the endoscope (not shown), the outer sleeve 1204 will release with the clip 1201 . The clip 1201 is released when the socket tabs 1203 at the proximal end of the clip 1201 are aligned with cut-outs 1205 in the outer sleeve 1204 . These cut-outs 1205 act as a relief area into which the socket tabs 1203 can be deformed when a predetermined tensile load is applied to them via the ball 1202 formed on the end of the control wire 1207 . The outer sleeve 1204 is released with clip 1201 so that the clip 1201 remains locked after deployment. Another alternative to the j-hook type frangible link is shown in FIGS. 13A , 13 B and 13 C. All the figures show the clip 1301 in a closed and locked state. FIG. 13A shows the clip 1301 in a closed position but before it is released and shows a portion of outer sleeve 1303 cut away to show the internal workings of the clip mechanism. FIGS. 13B and 13C show the clip 1301 after being released. In this embodiment, the actuation is still performed via a control wire 1304 , however the direction of action is reversed. As the control wire 1304 is pushed forward, the clip 1301 is closed by the advancement of outer sleeve 1303 and lock ring 1302 over the clip legs. The locking sleeve 1302 and clip geometry, including dimples 1306 , is the same as that explained in the embodiment of FIG. 11 . A difference between the embodiment shown in FIGS. 13A , 13 B and 13 C and the prior embodiments is the mechanism by which the clip 1301 is released from the rest of the device. An interference fit between the outer sleeve 1303 , sheath 1305 , and male threaded hub 1308 is created when the device is assembled. The distal end of the sheath 1305 , in its manufactured (but unassembled) state, has an outside diameter greater than the inside diameter of the outer sleeve 1303 . When the outer sleeve 1303 and sheath 1305 are assembled together part of the interference fit is created. The distal end of the sheath 1305 , again in its manufactured (unassembled) state, has an inside diameter greater than the diameter of the male threaded hub 1308 . During assembly, as the distal end of the sheath 1305 is compressed to fit inside the outer sleeve 1303 , it is compressed down onto the male threaded hub 1308 to create a sandwich of the sheath 1305 between the male threaded hub 1308 on the inside and the outer sleeve 1303 on the outside. During the medical procedure, at the time the operator wishes to release the clip 1301 , this interference fit is overcome. The interference fit is overcome by advancing the outer sleeve 1303 so far forward, by creating a compressive force in the control wire 1304 in opposition to a tensile force on the sheath 1305 , that the outer sleeve 1303 is no longer in contact with the distal end of the sheath 1305 . The outer sleeve 1303 and the control wire 1304 serve two purposes in this embodiment. The outer sleeve 1303 and the control wire 1304 supply the closing force to the clip 1301 . In FIGS. 13A , 13 B, and 13 C, a lock ring 1302 is used to maintain the closing force on the clip legs 1307 . The outer sleeve 1303 and the control wire 1304 also act as key components of the release mechanism. As previously described, once the outer sleeve 1303 is moved to its forward-most position, the end of the sheath 1305 is no longer contained within the outer sleeve 1303 , and is free to separate from the male threaded hub 1308 . The sheath 1305 is free to release because of the manner in which the distal end of the sheath 1305 is manufactured/assembled. When the outer sleeve 1303 is advanced forward, allowing the distal end of the sheath 1305 to be free, the distal end of the sheath 1305 expands to its original, manufactured state. This allows the inside of the sheath 1305 to release from the male threaded hub 1308 . The male threaded hub 1308 , and thus the clip 1301 , are now free from the sheath 1305 and the rest of the delivery device. As shown in FIG. 13C , the outer sleeve 1303 remains connected to the control wire 1304 at connection point 1310 , and both can be removed with the sheath 1305 . The distal portion of control wire 1304 is bent towards, and connects with, outer sleeve 1303 at connection point 1310 . The distal portion of control wire 1304 passes male threaded hub 1308 during deployment through slot 1309 in male threaded hub 1308 . FIGS. 14A , 14 B, and 14 C show an alternative embodiment of the present invention. In the embodiment of FIGS. 14A , 14 B, and 14 C, the relaxed state of the clip is closed, and it is forced open and allowed to close naturally. FIG. 14A shows a side view of the clip 1401 in a closed, pre-released state, and FIG. 14B shows an edge view of the clip 1401 in a closed, pre-released state. In this embodiment, because the clip 1401 is manufactured such that the clip legs 1407 are naturally closed, the primary function of the control wire 1406 is changed from having to close the clip 1401 , to having to open the clip 1401 . The clip 1401 is manufactured in a generally x-shaped geometry, where each tab 1403 at the proximal end of the clip 1401 controls a clip leg 1407 opposite at the distal end of the clip 1401 . The action/reaction of the clip 1401 is similar to that of a common clothes pin. As the tabs 1403 are brought together, the clip legs 1407 are spread apart. As the tabs 1403 are released, the clip legs 1407 come together. A u-ring 1402 attached to the end of the control wire 1406 is used to bring the tabs 1403 together, thus opening the clip 1401 . Pulling on the control wire 1406 pulls the u-ring 1402 into contact with tabs 1403 creating a compressive force to open clip legs 1407 because clip 1401 is positioned against fulcrum point 1408 . Advancing control wire 1406 advances u-ring 1402 , thereby removing the compressive force on tabs 1403 and allowing clip legs 1407 to close. Advancing control wire 1406 further to a deployment position pushes u-ring 1402 against clip legs 1407 , causing clip 1401 to move out of outer sleeve 1404 into a deployed state. The control wire 1406 is constructed of material having a shape memory, and the distal end of the control wire 1406 , where the u-ring 1402 is attached, is pre-bent to one side. While a minimum tension exists in control wire 1406 , the u-ring remains around the constriction. However, when the desired location for the clip 1401 has been achieved, and the clip tabs 1403 have been advanced beyond outer sleeve 1404 , the control wire 1406 can be advanced to its most distal position. Because the control wire 1406 is pre-bent, as it is advanced the u-ring 1402 becomes disengaged from the clip 1401 when the tension in control wire 1406 falls below a pre-determined amount, as shown in FIG. 14C . This allows the clip 1401 to be released. FIGS. 15A , 15 B, 15 C, and 15 D show another embodiment in which the clip is manufactured in a naturally closed position. FIG. 15A shows the distal end of medical device 1509 with the clip 1501 in a closed position before deployment. FIG. 15B shows only the clip 1501 in a closed position. FIG. 15C shows the clip 1501 in an open position. FIG. 15D shows the device after the clip is released. The clip 1501 is shaped such that, as the control wire 1503 is pulled in a proximal direction, the clip legs 1508 are forced apart from one another. This is accomplished using a pill 1502 attached to the end of the control wire 1503 as explained in previous embodiments. Two rigid arms 1504 , located, between the clip legs 1508 , translate the tensile force on the control wire 1503 to an outward radial force on the clip legs 1508 . When the desired location for the clip 1501 has been achieved, the control wire 1503 can be advanced to its most distal position. Because the control wire 1503 is constructed of material that has a shape memory, and because the control wire 1503 is pre-bent close to the pill 1502 , as the control wire 1503 is advanced, the pill 1502 becomes disengaged from the pill well 1507 . When the pill 1502 moves out and away from the pill well 1507 , the clip 1501 is released and disengages from the control wire 1502 , the sheath 1506 , and the outer sleeve 1505 . FIGS. 16A , 16 B, 16 C, 16 D, and 16 E show another embodiment in which the clip is manufactured in a naturally closed position. FIG. 16A shows the clip 1607 in a closed, predeployed, state. FIG. 16B shows a side view of one clip leg 1601 with the pill 1603 still resting in pill well 1604 . FIG. 16C shows an edge view of one clip leg 1601 with the pill 1603 still resting in pill well 1604 . FIG. 16D shows a clip 1607 in an open position. FIG. 16E shows a clip 1607 in a closed position. This embodiment uses two control wires 1605 . Alternatively, a branched control wire may be used. By using a branched control wire or two control wires 1605 , the force can be transmitted to a point further away from the fulcrum (bending point) 1606 of the clip 1607 . The greater this distance, the lesser the force required to open the clip legs 1601 . As in the previous embodiments, the control wires 1605 are disengaged from the clip 1607 by pushing them forward. This action disengages the pills 1603 from the clip 1607 by moving the pills 1603 out of pill wells 1604 . The control wires 1605 are made from a material with a shape memory, so that when freed from pill wells 1604 , the pills 1603 move away from the pill wells 1604 , and the clip 1607 is deployed. Another embodiment is shown in FIGS. 17A and 17B . In this embodiment, the control wire or wires 1701 are routed to gain mechanical advantage. In this embodiment, the clip 1702 is naturally closed, with the control wire(s) 1701 routed to leverage points 1704 further away from the fulcrum (bending point) 1705 of the clip 1702 . In this embodiment, the control wire(s) 1701 are looped around pins positioned at leverage points 1704 at the ends of the clip legs 1706 . The control wire(s) 1701 are then routed to a point at the proximal end of the clip. The control wire(s) 1701 are then terminated at this point. For ease of manufacture, the control wire(s) 1701 could essentially be one, continuous wire, with both ends terminated in the handle (not shown). To release the clip 1702 , one end of control wire 1701 could be detached from the handle and pulled free from the clip 1702 . Because the control wire 1701 is only wrapped around pins positioned at leverage points 1704 on the clip 1702 , by pulling on one end of control wire 1701 , control wire, 1701 could be easily detached when the desired location for clip 1702 has been achieved by continuing to pull on one end of control wire 1701 until all of control wire 1701 has been detached from the clip 1702 . FIGS. 18A , 18 B, 18 C, 18 D, 18 E, and 18 F show an embodiment of a clip which incorporates the natural compressive forces present in a simple elastic band (or o-ring) 1802 to hold the clip legs 1801 in the closed position. FIG. 18A shows two clip legs 1801 in a disassembled state. FIG. 18B shows a clip with the control wire 1803 engaging a second elastic band 1804 to open clip legs 1801 . In this embodiment, the control wire 1803 is attached to the proximal end of the clip legs 1801 via a frangible link. In this embodiment, the frangible link is a second elastic band (or o-ring) 1804 that will deform as the control wire 1803 is pulled back. In this embodiment, the clip is housed in the end of a sheath 1806 such that, as the control wire 1803 is pulled back, the second elastic band 1804 delivers an increasing compressive force to the clip legs 1801 proximal to a pin joint 1805 , thereby causing the clip legs 1801 distal from the pin joint to open against the compressive force of elastic band 1802 . In this manner, the clip legs 1801 move to an open position, as shown in FIG. 18B . FIG. 18C shows the clip in a closed, predeployed state. FIG. 18D shows a profile view of clip legs 1801 , and FIG. 18E shows an end-on view of clip legs 1801 within sheath 1806 . FIG. 18F shows a close-up view of clip legs 1801 without first elastic band 1802 but showing band slots 1809 . FIG. 18F shows second elastic band 1804 resting over nubs 1807 and coupled to control wire 1803 . When the desired clip location has been achieved, the second elastic band 1804 , which makes up the frangible link, is overcome by pulling the control wire 1803 to its most proximal position. This has the effect of breaking second elastic band 1804 . Alternatively, second elastic band 1804 could be designed to release over nubs 1807 . In a third alternative, after placing clip legs 1801 in the desired location, control wire 1803 can be released so that elastic band 1802 again closes clip legs 1801 . In this third embodiment, control wire 1803 is made of a suitable material, such as a shape memory material, and has a bend in the distal region such that moving control wire 1803 to a maximum distal position acts to unhook hook 1808 from second elastic band 1804 . FIGS. 19A , 19 B, and 19 C show another embodiment of the invention utilizing a naturally closed clip. Clip 1901 is held in the naturally closed position by a torsion spring 1903 . The clip 1901 is actuated from the closed to the opened position in a different way than prior embodiments. A plunger 1904 , located within the outer sleeve 1905 at the end of the sheath (not shown), is used to push on the tabs 1906 on the proximal end of the clip 1901 . The tabs 1906 are pushed through an opening 1907 in the end of the outer sleeve 1905 . This moves tabs 1906 close together, in turn moving the clip legs 1902 to the open position. When the desired clip location has been achieved, the clip 1901 can be released by advancing the plunger 1904 to its most distal position. FIG. 19B shows the clip 1901 from a profile view. FIG. 19C shows a single clip leg 1902 and connection point 1908 for pivotally connecting clip legs 1902 to each other. FIGS. 20A , 20 B, and 20 C describe the embodiment of a three-legged clip and delivery device. The clip 2001 is manufactured to be in the naturally open position. The clip 2001 is characterized by male threads 2002 on its outer surface. The delivery device consists of a sheath 2003 similar to those described in previous embodiments. An inner sleeve 2004 located within the distal end of the sheath 2003 is used to actuate the clip 2001 from its naturally open position to the closed position. The inner sleeve 2004 has female threads (not shown) on its inside diameter. A control wire (not shown) is used in this device to transmit rotational force rather than tensile/compressive force. Rotating the sheath 2003 with respect to the control wire, with the handle (not shown) actuates the clip 2001 . This rotation force is translated to the female threads, causing them to be threaded onto the clip 2001 . As the naturally open clip legs 2005 move toward the inner sleeve 2004 , the clip legs 2005 are closed. The clip 2001 and inner sleeve 2004 are released from the sheath 2003 via some form of frangible link (not shown) as described in the previous embodiments. FIG. 20A shows the clip legs 2005 and inner sleeve 2004 from the perspective of the target area. FIG. 20C shows the size relationship between the female threads on the inner sleeve 2004 and the male threads 2002 on the clip 2001 . FIG. 21 shows another embodiment of a naturally open clip and delivery device. FIG. 21 shows the distal portion of the medical device with a portion of the outer sleeve 2102 cut away to show the inner mechanics of the clipping device. The delivery device consists of a sheath 2103 similar to those described in previous embodiments. The clip 2101 is actuated from the open to the closed position via a control wire 2104 , as described in the primary embodiment. A frangible link is implemented in this embodiment by a breakable link 2105 . In this embodiment the lock sleeve is eliminated. Eliminating the lock sleeve reduces the number of components and the overall size of the device. In this embodiment the outer sleeve 2102 is used to hold the clip 2101 in the closed position. Therefore, the outer sleeve 2102 must be deployed from the sheath 2103 when the clip 2101 is released. To create a positive mechanical lock between the clip 2101 and outer sleeve 2102 , the clip 2101 has two deformable tabs 2106 formed in its proximal end. When the desired tissue purchase has been accomplished, the control wire 2104 is further actuated by the handle (not shown) so that the tabs 2106 reach a position where they are in the same plane as the cut-outs 2107 in the outer sleeve 2102 . Once the tabs 2106 have reached this point, further actuation of the control wire 2104 forces the tabs 2106 to deform through the cut-outs 2107 in the outer sleeve 2102 . As in the first embodiment, a retainer 2108 is used to create a mechanical lock between the sheath 2103 and outer sleeve 2102 . In this embodiment the retainer 2108 passes through slots 2109 in the outer sleeve 2102 and a sheath connector 2110 . The sheath connector 2110 is simply a rigid connector, applied to the end of the sheath 2103 by some means known in the art (e.g. welding, adhesive, swaging, etc.). As the tabs 2106 become engaged, a tensile load in the control wire 2104 is translated to the breakable link 2105 . At a predetermined tensile load, the breakable link 2105 breaks. As the control wire 2104 is further actuated, a distal portion of control wire 2104 , which is preformed into a shape that will function as a retainer release, engages the retainer 2108 . The retainer 2108 is pulled from the outer sleeve 2102 by the control wire 2104 , in a similar manner to that described in the primary embodiment. Once this is done, the sheath connector 2110 (and therefore the sheath 2103 ) is released from the outer sleeve 2102 . The materials utilized in construction of the clip of the present invention include many bio-compatible materials (metals, polymers, composites, etc.). A stainless steel grade material, which offers good spring properties, may be used. The clip can also be coated, or plated, with a material like gold to improve. radiopacity. The lock sleeve, lock pawls, retainer and outer sleeve may be comprised of any of the same materials as the clip component. For example, stainless steel may be used. The control wire in the first embodiment may be a stainless steel wire. Because the wire must offer sufficient strength in both tension and compression, the material properties of the wire are important to the functionality of the device. Also, the end of the wire, where the j-hook is formed, must deform when a predetermined tensile load is applied. The device's ability to release the clip is dependent on this property. Other embodiments of the device may incorporate a two (or more) piece wire so that certain sections of the wire have different material properties or geometries. Different material properties or geometries could allow for more control over how and when the wire detaches from the distal tip of the device. This could also be accomplished by several other methods, as well. For example, localized heat treating and/or coatings could be used along portions of the wire to alter the material characteristics. Additionally, some embodiments of the present invention require a control wire constructed of a material with a shape memory. The sheath, in the first embodiment, is made up of several round, stainless steel wires, wound in a helical pattern to create a hollow, semi-rigid shaft. Sheaths made in this fashion are well known in the prior art. In other embodiments, the sheath could be made up of non-round wires. Other embodiments may be made up of one or more wires formed in a pattern other than a single helix, as in the first embodiment. A multiple helix or braided pattern may be used. The sheath may also be coated with a protective coating of Polytetrafluoroethylene (PTFE), or similar materials. The use of such coatings could be used to alter the flexibility of the shaft. Such coatings could also be used to increase the lubricity (decrease the coefficient of friction) between the endoscope working channel and the device. Similar materials could also be used to encapsulate the sheath's base material. This would create a matrix material, providing a combination of material properties not feasible with one single material. Other embodiments may use materials other than stainless steel as the base material. Materials such as titanium, nitinol, and/or nylon fibers may be incorporated. A method of using the endoscopic hemostatic clipping device is provided. The method involves placing an endoscope in a body cavity as is known in the art. The device provided herein is then inserted through the endoscope. At the distal end, the endoscope is positioned near the target area. As noted above, the target area may be a lesion, a bleeding ulcer, a tumor, other abnormality, or any number of other tissues to be pinched, marked, tagged, or to which the operator wishes to apply a pinching pressure for whatever reason. The device provided is then positioned so that the clip legs embrace the target area, then the actuator is activated to close the clip legs. The success or failure of the application of pressure can be reviewed through the optical components provided separately in the endoscope. If the pinching is unsuccessful or only marginally successful, the clip legs of the device may be opened by reversing the actuation of the activator. Alternatively, if the pinching is successful, and the operator wishes to deploy the device, the actuator is fully activated, or the alternative deployment activator is activated. Finally, the remaining portion of the medical device and the endoscope are removed from the body. It will be obvious to those skilled in the art, having regard to this disclosure, that other variations on this invention beyond those specifically exemplified here may be made. These variations include, but are not limited to, different combinations of clips, closing mechanisms, locking mechanisms, frangible links, and clip leg formations. Such variations are, however, to be considered as coming within the scope of this invention as limited solely by the following claims.

Medical device used to cause hemostasis of blood vessels using a clip arrangement delivered to a target region through an endoscope. Method for using the device to cause hemostasis of a blood vessel through an endoscope. Medical device including a reversibly closeable clip, a locking arrangement, a control wire, a sheath, and a handle with an actuating trigger. Through the endoscope, hemostatic clipping device that is fully reversible and lockable. Hemostatic clip that reversibly targets and clips bleeding ulcers.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to surgical device design and fabrication and, more particularly, to a shaft for medical catheters. [0003] 2. Background of the Invention [0004] Medical catheters, such as balloon catheters, have been proven efficacious in treating a wide variety of blood vessel disorders. Moreover, these types of catheters have permitted clinicians to treat disorders with minimally invasive procedures that, in the past, would have required complex and perhaps life threatening surgeries. For example, balloon angioplasty is now a common procedure to alleviate stenotic lesions (i.e., clogged arteries) in blood vessels, thereby reducing the need for heart bypass operations. [0005] Previously known catheters are of complex construction, requiring expensive manufacturing steps and construction of great precision to navigate the tortuous pathways of a vessel network. For instance, when a catheter provides inflation fluid to a balloon, a small notch is typically provided in the catheter tube to allow fluid to pass from a lumen within the tube to the balloon. The conventional method for manufacturing this notch is with a laser, which is expensive and often cannot be done in-house. Further, use of a laser creates a heat-affected zone which can lead to fracture of the notch. Moreover, the heat from the laser may cause deformation of the material. This is especially problematic when a straight catheter made of a nickel-titanium alloy is desired. Because the properties of NiTi alloys are extremely temperature sensitive, laser notching may cause buckling or unwanted curvature in the material. Accordingly, there is a need for a notch-forming process which will not cause damage to the material. [0006] Further, profile is often a concern for catheters because of the small space in which the catheters will be inserted. In addition, because catheters must be passed through a tortuous blood vessel network to reach the intended treatment site, it is desirable that the catheters be substantially frictionless to reduce harmful contact with blood vessel walls. Catheters therefore are generally provided with a coating that will increase lubricity of the catheter. These coatings add additional, undesired size to the catheter. Thus, there is a need for a substantially frictionless catheter surface which does not add significant profile to a catheter tube. [0007] In navigating the pathways of a vessel network, a radiopaque marker is often necessary to identify a specified location on the catheter. Such markers are typically placed on the catheter tube near the location of a distal balloon. However, in medical devices employing aspiration catheters and the like, visibility problems often arise with such markers because they are typically made small in order to allow the aspiration catheter to be passed over the marker as it extends towards the distal balloon. Accordingly, there is a need for balloon catheters having markers which can better identify the location of a balloon while inside a blood vessel. SUMMARY OF THE INVENTION [0008] The present invention addresses the needs raised above by providing several improvements in the design of a shaft for medical catheters. In one aspect, a small notch is fabricated into a catheter tube by a nonlaser process such as electric discharge machining (EDM) or mechanical grinding. This notch in the catheter tube is necessary for fluid communication between the catheter lumen and a balloon or other element in communication with the tube. Use of a nonlaser process reduces the costs of fabrication while ensuring a high degree of structural integrity. [0009] In another aspect of the present invention, a method is provided to produce a thinner coating on a catheter shaft to reduce friction with vessel walls. To maintain a surface with a low friction coefficient while keeping the profile of the catheter low, the catheter is sputter coated with Teflon or similar material to produce a nonuniform coating. This nonuniform coating may extend 360 degrees around the catheter tube, and may even provide a coating of less than 360 degrees while still maintaining good lubricity. [0010] In yet another aspect, a catheter wire or tube is provided with a radiopaque marker which is more visible and is more effective at identifying the location of a balloon on the catheter. The marker is moved closer to a distal balloon by placing it within an adhesive taper adjacent the balloon. By placing the marker in the taper, the marker can be made larger and more visible without obstructing the placement of an aspiration catheter or other type of catheter over the catheter wire or tube. Specifically, the marker in being placed inside the taper and closer to the balloon can act as a stopper to the aspiration catheter and prevent damage to the balloon. BRIEF DESCRIPTION OF THE DRAWINGS [0011] [0011]FIG. 1 is a side view of the catheter of the present invention. [0012] [0012]FIG. 2 is a longitudinal cross-sectional view of the distal end of a catheter having the improvements of the present invention. [0013] [0013]FIG. 3 is an enlarged cross-sectional view along area 3 - 3 of FIG. 2. [0014] [0014]FIG. 4A is a cross-sectional view along line 4 - 4 of FIG. 1 showing a nonuniform coating on the catheter. [0015] [0015]FIG. 4B is a cross-sectional view along line 4 - 4 of FIG. 1 showing an alternate embodiment of a nonuniform coating on the catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0016] Referring to FIG. 1, there is depicted a catheter 10 incorporating the improvements of the present invention. Although the improvements of the present invention are depicted and discussed in the context of being part of a simple occlusive device having a single lumen, it should be appreciated that the present invention is applicable to more complex occlusive devices having structures and functionalities not discussed herein. For example, the present inventors contemplate that the improvements of the present invention may be used in occlusive devices functioning as anchorable guide wires or filters. In addition, the improvements of the present invention are also applicable to catheters having other types of balloons, such as latex or silicone, or to catheters having dilatation balloons, made of materials such as polyethylene terephthalate. Moreover, the improvements of the present invention may also be adapted to other types of catheters used in drug delivery or radiation therapy, such as irrigation catheters, and to catheters having no balloon at all. The manner of adapting the improvements of the present invention to these various structures and functionalities will become readily apparent to those of skill in the art in view of the description which follows. [0017] In FIG. 1, an occlusion balloon catheter 10 is shown. Catheter 10 generally comprises an elongate flexible shaft or tubular body 12 extending between a proximal control end 14 , corresponding to a proximal section of tubular body 12 , and a distal functional end 16 , corresponding to a distal section of tubular body 12 . Tubular body 12 has a central lumen 18 which extends between ends 14 and 16 . An inflation port 20 is provided on tubular body 12 near the proximal end 14 . Inflation port 20 is in fluid communication with lumen 18 , such that fluid passing through inflation port 20 into or out of lumen 18 may be used to inflate or deflate inflation balloons in communication with lumen 18 . Lumen 18 is sealed fluid tight at distal end 16 . Inflation port 20 may be similar to existing female luer lock adapters or would be a removable valve at the end, as disclosed in assignee's co-pending application entitled LOW PROFILE CATHETER VALVE AND INFLATION ADAPTER, application Ser. No. 08/975,723 filed Nov. 20, 1997, the entirety of which is incorporated by reference. [0018] The length of tubular body 12 may be varied considerably depending upon the desired application. For example, where catheter 10 serves as a guidewire for other catheters in a conventional percutaneous transluminal coronary angioplasty procedure involving femoral artery access, tubular body 12 is comprised of a hollow hypotube having a length in the range of from about 160 to about 320 centimeters with a length of about 180 centimeters being optimal for a single operator device and 300 centimeters for over the wire applications. Alternately, for a different treatment procedure, not requiring as long a length of tubular body 12 , shorter lengths of tubular body 12 may be provided. Moreover, the catheter 10 may comprise a solid shaft rather than a hollow hypotube. [0019] Tubular body 12 generally has a circular cross-sectional configuration with an outer diameter within the range of from about 0.008 inches to 0.14 inches. In many applications where catheter 10 is to be used as a guidewire for other catheters, the outer diameter of tubular body 12 ranges from 0.010 inches to 0.038 inches, and preferably is about 0.014 to 0.018 inches in outer diameter or smaller. Noncircular cross-sectional configurations of lumen 18 can also be adapted for use with the present invention. For example, triangular, rectangular, oval, and other noncircular cross-sectional configurations are also easily incorporated for use with the present invention, as will be appreciated by those of skill in the art. [0020] Tubular body 12 has sufficient structural integrity, or “pushability,” to permit catheter 10 to be advanced through vasculature to distal arterial locations without buckling or undesirable kinking of tubular body 12 . It is also desirable for tubular body 12 to have the ability to transmit torque, such as in those embodiments where it may be desirable to rotate tubular body 12 after insertion into a patient. A variety of biocompatible materials, known by those of skill in the art to possess these properties and to be suitable for catheter manufacture, may be used to produce tubular body 12 . For example, tubular body 12 may be made of stainless steel such as Elgiloy (TM), or may be made of polymeric materials such as nylon, polyimide, polyamides, polyethylene or combinations thereof. In one preferred embodiment, the desired properties of structural integrity and torque transmission are achieved by forming tubular body 12 out of an alloy of titanium and nickel, commonly referred to as nitinol. In a preferred embodiment, the nitinol alloy used to form tubular body 12 is comprised of about 50.8% nickel and the balance titanium, which is sold under the trade name Tinel (TM) by Memry Corporation. It has been found that a catheter tubular body having this composition of nickel and titanium exhibits an improved combination of flexibility and kink resistance in comparison to other materials. Further details are disclosed in assignee's co-pending applications entitled HOLLOW MEDICAL WIRES AND METHODS OF CONSTRUCTING SAME, application Ser. No. 08/812,876, filed on Mar. 6, 1997, CATHETER BALLOON CORE WIRE, application Ser. No. 08/813,024, filed Mar. 6, 1997, and CORE WIRE WITH SHAPEABLE TIP (Attorney Docket PERCUS.053A), application Ser. No. ______, filed on the same date herewith, all of which are hereby incorporated by reference in their entirety. [0021] As illustrated in FIG. 1, an expandable member such as an inflatable balloon 22 is mounted on tubular body 12 . Balloon 22 may be secured to tubular body 12 by any means known to those skilled in the art, such as adhesives or heat bonding. In one preferred embodiment, balloon 22 is a compliant balloon formed out of a material comprising a block polymer of styrene-ethylene-butylene-styrene (SEBS). As shown in FIGS. 2 and 3, balloon 22 has a proximal end 24 and a distal end 26 which are both secured to the outer surface of tubular body 12 . Balloon 22 may be secured to the tubular body 12 by any means known to those of skill in the art, such as adhesives or heat bonding. FIGS. 2 and 3 show the use of adhesives 28 bonding the balloon at its proximal end 24 and distal end 26 , respectively, up to adhesive stops 32 and 34 , the distance between the adhesive stops defining the working length of the balloon. Further details are disclosed in assignee's co-pending application entitled BALLOON CATHETER AND METHOD OF MANUFACTURE (Attorney Docket PERCUS.010CP1), application Ser. No. ______, filed on the same date herewith, the entirety of which is hereby incorporated by reference. [0022] A notch 36 is provided in the tubular body 12 , as shown on the back side of tubular body 12 in FIG. 2, within the working length of the balloon to provide fluid communication between the lumen 18 and the balloon 22 . A core wire 38 is provided at the distal end of the tubular body 12 , inserted into the lumen 18 so that part of the core wire 38 is visible through the notch 36 . Coil 40 surrounds the core wire 38 and is soldered at a distal end into a rounded tip 42 . The core wire 38 is secured within the lumen 18 of tubular body 12 by a combination of adhesive bonding and crimping at points 44 and 46 of the tubular body 12 . Tapers 48 and 50 are shown at the proximal and distal ends of the balloon 22 , respectively. A radiopaque marker 52 is located within the proximal taper 48 . [0023] The core wire 38 and the coil 40 are formed into a subassembly prior to attachment to tubular body 12 . Once the coil 40 is attached to the core wire, a proximal end of core wire 38 is inserted into tubular body 12 at distal end 54 . Two crimps 44 and 46 are provided near the distal end 54 of the tubular body 12 to secure the core wire 38 to the tubular body. The crimps are preferably located in a location between the notch 36 and the distal end 54 of the tubular body 12 . The crimps are preferably located a distance 0.5 to 1.5 mm apart, and more preferably, about 1.0 mm apart. The more distal crimp 46 preferably is located about 0.5 mm from the distal end 54 of tubular body 12 . Further details are disclosed in the above-referenced application CORE WIRE WITH SHAPEABLE TIP (Attorney Docket PERCUS.053A), application Ser. No. ______, filed on the same date herewith. Fabrication of the Notch [0024] In one aspect of the present invention, the notch 36 shown in FIG. 2 is formed by a nonlaser process. Preferably, the process used is electric discharge machining (EDM). This method allows removal of metal by a series of rapidly recurring electrical discharges between an electrode (the cutting tool) and the workpiece in the presence of a liquid (usually hydrocarbon dielectric). Using EDM, the notch 36 can be made economically but also with great precision. The notch 36 preferably has a length between 0.001 and 0.005 inches and a width between 0.001 and 0.005 inches, depending on the working length of the balloon 22 and the diameter of the tubular body 12 . As shown in FIG. 2, when the distance between the inner surfaces of the adhesive stops 32 and 34 is 4 mm and the outer diameter of the tubular body 12 is 0.0132 inches, the notch 36 preferably has a length of 1.5 mm and a width of 0.003 inches. The notch 36 may be centered within the working length of the balloon, such that the distance between the ends of the notch and each of the adhesive stops 32 and 34 is the same. Alternatively, when the core wire 38 extends into the lumen 18 of the tubular body 12 and is visible in the notch 36 , the location of the notch 36 may be shifted towards distal end 54 of the tubular body. In FIG. 2, where the distance between adhesive stops 32 and 34 is 4 mm, the core wire 38 extends 0.5 mm into the notch 36 . The notch 36 is 1.5 mm long, with the proximal end 56 of the notch 36 located a distance 1.5 mm from the first adhesive stop 32 , and the distal end 58 of the notch 36 located 1 mm from the second adhesive stop 34 . [0025] To manufacture the notch, preferably, an EDM with a 0.0055±0.0005 inch electrode is used. A current of 0.5 amps is applied, with an on time of 6 seconds and an off time of 50 seconds. Although the EDM processing of the notch has been described with respect to specific parameters, it should be recognized that other parameters as well may be used for the EDM. Furthermore, EDM may be used not only for fabrication of a distal notch to inflate a balloon, but also for a notch such as inflation port 20 at the proximal end of the tubular body as shown in FIG. 1, or other types of notches that may be provided for a medical catheter. [0026] Although fabrication of the notch has been described with reference to an EDM procedure, other nonlaser processes may be used as well. For instance, mechanical grinding is another low cost procedure for fabricating a notch that can be performed in-house. Nonuniform Coating [0027] In another aspect of the present invention, the shaft or tubular body 12 is sputter-coated with a polymeric material to reduce friction between the catheter and blood vessels and produce a lubricious, nonuniform coating on the tubular body 12 . As used herein, “nonuniform” refers either to a coating that is variable in thickness along the circumference or length of the body 12 , or to a coating which covers the body 12 in some areas but not at all in others. As shown in FIG. 1, a coating 60 is applied to the tubular body 12 between a proximal marker 62 and the balloon 22 . The coating begins at a distance preferably within about 5 mm of the marker 62 , and more preferably within about 2 mm. The coating 60 terminates preferably within about 1 cm of the proximal taper 48 . Preferred coating materials include polytetrafluoroethylene (TFE), with Teflon being a desired material for the coating 60 . Those skilled in the art will recognize that similar materials with high lubricity may be used. [0028] As shown in FIGS. 4A and 4B, a nonuniform coating 60 adds very little dimension to the tubular body 12 . FIG. 4A shows one embodiment where the coating 60 is thin with a variable thickness that covers substantially the entire circumference of the tubular body 12 . FIG. 4B shows another embodiment where the coating 60 is thin but does not coat the entire circumference of tubular body 12 . Thicknesses in the range of about 0.001 to about 0.0035 inches are preferred. In both of the embodiments shown in FIGS. 4A and 4B, preferably, the coating 60 has a thickness of no greater than about 0.01 inches, and more preferably, the coating thickness is no greater than about 0.0035 inches. Thus, it has been discovered that sufficient lubricity can be achieved with a nonuniform or even intermittent, sporadic coating, while simultaneously maintaining a low profile. [0029] To apply the polymeric coating 60 to the tubular body 12 , the surface of the tubular body 12 is first cleaned. Preferable cleaning methods are by preparing a cleaning solvent blend using a 1:1 (by volume) mixture of acetone and isopropyl alcohol. The tubular body 12 may be cleaned by wiping the body with a lint-free towel or cloth wetted by this solvent blend. After the solvent wipe, the tubular body 12 is heat cleaned in an oven for 15 minutes at 540° F. [0030] The Teflon coating solution may be Xylan 1006/870 Black Teflon coating as obtained from Whitford Corporation. To achieve a thinner film thickness, the coating can be mixed with a thinner such as thinner #99B from Whitford Corporation. To mix the coating solution with the thinner, the coating solution is first mixed well in a container using a mechanical stirrer for about 5 to 10 minutes to remove residue and Teflon particles from the bottom of the container. About 80 parts by volume of the coating solution is mixed with about 20 parts by volume of the thinner with a mechanical stirrer until the blend is uniform to achieve 0.0035 inch thickness. This blend is filtered using a cone type coarser filter paper to remove lumps. After completing these steps, the coating solution is ready to spray. [0031] The coating is produced on the tubular body by a spray gun, preferably with an agitating pressure pot, although a spray gun without an agitating pressure pot may be used. The spraying process of the present invention preferably produces a nonuniform Teflon coating 360 degrees around the tubular body and extending continuously along the length of the tubular body 12 . When applying the coating with the spray gun, rather than pulling the trigger all the way and holding it continuously, the trigger can be selectively depressed and released, or depressed with various degrees of pressure, as the gun passes from left to right over a portion of the tubular body. This process is repeated as the tubular body is rotated and a coating is applied 360 degrees around the tubular body. Coating on the tubular body by the spray gun can also be adjusted by controlling the flow rate of the spray exiting the gun. Moreover, the motion of the gun over the body allows control of the thickness and uniformity of the coating. These factors allow the coating 60 to be a thin, nonuniform coating covering substantially all of the tubular body, as shown in FIG. 4A. [0032] Alternatively, the profile of the catheter can be reduced even further by spraying less than 360 degrees around the tubular body 12 , as shown in FIG. 4B. The nonuniformity of the coating, thus, results from the tubular body 12 having portions that are coated with the polymer and other portions having no coating at all. The degree of nonuniformity depends on how the trigger of the spray gun is selectively activated and deactivated. Other methods to produce nonuniformity on the tubular body 12 , such as masking portions of tubular body 12 , may also be used. Moreover, the nonuniformity may result from the coating not being sprayed continuously over the circumference and/or length of the body. [0033] After spraying, the coating should be flashed off to avoid any blistering. The coated tubular bodies are flashed off in an oven at 200° F. for 15 minutes. Then, the tubular body is cured. When a NiTi material is used for the tubular body, a curing temperature of about 540° F. is used in order to maintain the heat treated superelastic properties of NiTi. The curing step takes about one-half hour. After allowing the coated tubular bodies to cool, parts of the tubular body may be stripped to remove the coating from undesired areas. For instance, at the location of the proximal marker 62 shown in FIG. 1, no coating is desired. Suitable means for stripping include an abrasive and a razor blade, as well as other stripping means known to those skilled in the art. Distal Marker [0034] In another aspect of the present invention, a tubular marker 52 , as shown in FIG. 2, is located within an adhesive taper 48 adjacent the balloon 22 . Although the marker 52 is shown in the form of a tube, it will be appreciated by those skilled in the art that markers of other shapes may be used as well. To place the marker 52 within the taper 48 , the marker is first slid over the coil 40 and core wire 38 and over the distal tip of the tubular body 12 past the inflation notch 36 so that it is out of the way for balloon bonding. Adhesive stops 32 and 34 and the balloon 22 are then mounted to the tubular body 12 using adhesives or other means known to those skilled in the art. One preferred method for mounting the adhesive stops and balloon to the tubular body is described in the above-referenced application BALLOON CATHETER AND METHOD OF MANUFACTURE (Attorney Docket PERCUS.010CP1), application Ser. No. ______, filed on the same day as the present application. [0035] After balloon bonding, the marker 52 is slid towards the balloon 22 such that it is between about 0.5 and 3 mm from the proximal end of the balloon. More preferably, the marker 52 is located within about 1.0 mm from the proximal end 24 of the balloon 22 . In the preferred embodiment shown in FIG. 2, the marker 52 is located about 0.75 mm from the balloon. The gap between the balloon 22 and the marker 52 is filled with an adhesive material taper 48 . Preferably, a cyanoacrylate adhesive such as LOCTITE 4011 is used. However, as will be appreciated by those of skill in the art, other adhesives may be used. The taper 48 also extends from the proximal end 64 of the marker to point 66 on the tubular body 12 , as well as from the proximal end 24 of balloon 22 to proximal end 64 of marker 52 . [0036] Because the marker is placed within the adhesive taper 48 of the balloon 22 , the marker can be made larger and closer to the balloon, thereby increasing visibility without obstructing advancement of an aspiration catheter or the like when the tubular body 12 is used as a guidewire. Further details regarding an aspiration catheter are disclosed in assignee's co-pending application entitled ASPIRATION CATHETER, application Ser. No. 08/813,308, filed Mar. 6, 1997, the entirety of which is hereby incorporated by reference. The marker preferably has an outer diameter of at least about 0.02 inches. More preferably, the marker 52 has an inner diameter of about 0.017 inches and an outer diameter of about 0.024 inches. The proximal cyanoacrylate balloon taper 48 is preferably about 4 mm long, extending from point 24 on the balloon 22 to point 66 on the tubular body. The marker taper, extending from point 24 to distal point 68 on marker 52 , is preferably about 0.75 mm long. [0037] It will be appreciated that certain variations of the shaft of the present invention may suggest themselves to those skilled in the art. The foregoing detailed description is to be clearly understood as given by way of illustration, the spirit and scope of this invention being limited solely by the appended claims.

Several improvements are provided in the design of a catheter shaft to reduce costs and improve performance. In one aspect, a small notch is fabricated into a catheter tube by a nonlaser process such as electric discharge machining (EDM) or mechanical grinding. This notch in the catheter tube is necessary for fluid communication between the catheter lumen and a balloon or other element in communication with the tube. Use of a nonlaser process reduces the costs of fabrication while ensuring a high degree of structure integrity. In another aspect, a method is provided to produce a nonuniform polymer coating on a catheter shaft to reduce friction and to maintain a catheter with a low profile. In another aspect, the catheter is provided with a radiopaque marker which is more visible and is more effective at identifying the location of a balloon. The marker is moved closer to a distal balloon by placing it within an adhesive taper adjacent the balloon.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 USC 119 (a)-(d) to Korea Application No. 10-2008-0119772 filed on Nov. 28, 2008, the contents of which are hereby incorporated by reference in their entirety. BACKGROUND OF THE INVENTION The present invention relates to a TRPA1 activity inhibitor, more precisely isopentenyl pyrophosphate, a compound for suppressing TRPA1 mediated pain by inhibiting TRPA1 activity and a novel use of the same. TRPA1 (transient receptor potential cation channel, subfamily A, member 1) was first found in 2003 owing to the studies in the fields of human physiology and pharmacology. TRPA1 is activated as it recognizes diverse stimuli such as low temperature stimulus, inflammatory stimulus, and mechanical stimulus, etc. And by the activation of TRPA1, the human body feels pain. TRPA1 belongs to thermoTRP family (temperature-sensitive transient receptor potential ion channels) that is the pain receptor family recognizing temperature and painful stimuli. Researches expect that human pain recognition mechanism can be explained by disclosing functions of TRPA1, the pain receptor, and additionally the pursuing goal of pain relief can be achieved by the development of a TRPA1 regulator. There is no report on an endogenous pain inhibitor, yet. Studies have been actively going on different types of pain, but mechanisms of pain regulators in vivo have not been disclosed yet. Prostaglandin generated by inflammation and its metabolites and aldehydes are known as pain inducing materials. To understand basic techniques used for the development of a pain inhibitor based on the TRPA1 specific inhibitor, it is important to understand the characteristics of TRPA1. TRPA1 is an ion channel and its activation makes cations migrate into sensory neurons, changing of cell membrane currents. The changes of cell membrane currents result in the generation of active potential, which is at last transferred to the brain to recognize pain. One of the techniques to measure TRPA1 activation is patch-clamp electrophysiological technique measuring the changes of membrane currents after amplifying thereof. And another technique to measure TRPA1 activation is to measure intracellular calcium level based on the fact that TRPA1 is involved in the migration of cations such as calcium ions. The first technique is superior in sensitivity to the second one, but the second technique is superior in high speed to the first one, so that they are complementary to each other. Such techniques to measure TRPA1 activation can be executed by the support of animal neuron culture technique, cell line culture technique, TRPA1 DNA control and transfection techniques. Various TRPA1 specific inhibitor candidates and a standard activator are administered to TRPA1 over-expressing cells and then inhibiting effect of TRPA1 activation therein is measured to select a proper TRPA1 inhibitor and determine its capacity. The present inventors constructed a cell line expressing TRPA1 and treated the cell line with isopentenyl pyrophosphate and cinnamaldehyde known as a TRPA1 activator. Then, responses therein were compared. At last the present inventors completed this invention by confirming that isopentenyl pyrophosphate inhibited TRPA1 activity and thus it could be effectively used as an inhibitor of TRPA1 mediated pain. SUMMARY OF THE INVENTION It is an object of the present invention to provide a method for inhibiting TRPA1 (transient receptor potential cation channel, subfamily A, member 1) activity using isopentenyl pyrophosphate. It is another object of the present invention to provide a method for screening a TRPA1 activity inhibitor using isopentenyl pyrophosphate. It is also an object of the present invention to provide a method for inhibiting pain of a subject using isopentenyl pyrophosphate. To achieve the above objects, the present invention provides a method for inhibiting TRPA1 (transient receptor potential cation channel, subfamily A, member 1) activity using isopentenyl pyrophosphate. The present invention also provides a method for screening a TRPA1 activity inhibitor comprising the following steps; 1) constructing a transformant by transfecting a host cell with a plasmid harboring the polynucleotide encoding TRPA1; 2) treating the transformant with TRPA1 specific activator and TRPA1 activity inhibitor candidates as the experimental group, and treating the transformant with TRPA1 specific activator and isopentenyl pyrophosphate as the control; 3) measuring TRPA1 ion channel activities in the experimental group and in the control group of step 2); and 4) comparing the results of step 3) and selecting TRPA1 activity inhibitor candidates from the experimental group that demonstrated lower or similar TRPA1 ion channel activity, compared with the control. The present invention further provides a method for inhibiting pain containing the step of administering a pharmaceutically effective dose of isopentenyl pyrophosphate to a subject. Isopentenyl pyrophosphate of the present invention can regulate pain caused by TRPA1, so that it can be effectively used for the development of a pain inhibitor which is effective but has less side effects. BRIEF DESCRIPTION OF THE DRAWINGS The application of the preferred embodiments of the present invention is best understood with reference to the accompanying drawings, wherein: FIG. 1 is a diagram illustrating that TRPA1 specific activity induced by cinnamaldehyde in mTRPA1 cell line was inhibited by isopentenyl pyrophosphate (CA: cinnamaldehyde). FIG. 2 is a diagram illustrating that TRPA1 activity was specifically inhibited by isopentenyl pyrophosphate in mTRPA1 cell line dose-dependently. FIG. 3 is a diagram illustrating that pain induced by cinnamaldehyde under normal or inflammatory condition was inhibited by isopentenyl pyrophosphate (CAR: carrageenan, CFA: complete Freund's adjuvant): a: 100 μM of isopentenyl pyrophosphate and 300 μM CA; b: 300 μM of CA and 300 μM of CA+100 μM of isopentenyl pyrophosphate; c: 50 μl of CAR+300 μM of CA+100 μM of isopentenyl pyrophosphate and 10 μl of CFA+300 μM of CA+100 μM of isopentenyl pyrophosphate; and, d: histogram illustrating the results of 10-minute reaction in FIG. 3 a - FIG. 3 c (The time required was statistically calculated by T-test, for which CA alone was regarded as standard). FIG. 4 is a diagram illustrating the changes of avoidance time from temperature stimulus by isopentenyl pyrophosphate under inflammatory condition: Control: carrageenan not treated group CAR: carrageenan treated group CAR+IPP: carrageenan and isopentenyl pyrophosphate treated group CAR+AP18: carrageenan and AP18 treated group. DETAILED DESCRIPTION OF THE INVENTION Hereinafter, the present invention is described in detail. The present invention provides a method for inhibiting TRPA1 activity containing the step of treating isopentenyl pyrophosphate to isolated sensory neurons expressing TRPA1. In a preferred embodiment of the present invention, it was confirmed that TRPA1 activity induced by cinnamaldehyde known as a TRPA1 specific activator was inhibited by isopentenyl pyrophosphate dose-dependently (see FIGS. 1 and 2 ). It was also confirmed that isopentenyl pyrophosphate inhibited TRPA1 mediated pain (see FIG. 3 ). Therefore, the said isopentenyl pyrophosphate can be effectively used for inhibiting TRPV3 activity. The preferable concentration of isopentenyl pyrophosphate was 10-100 μM. In a preferred embodiment of the present invention, the TRPA1 inhibitor was confirmed to inhibit TRPA1 activity at micro-molar concentration range (see FIG. 2 ). Isopentenyl pyrophosphate of the present invention can be formulated for oral administration, for example powders, granules, tablets, capsules, suspensions, emulsions, syrups and aerosols, and for parenteral administration, for example external use, suppositories and sterile injections, etc. Solid formulations for oral administration are powders, granules, tablets, capsules, soft capsules and pills. Liquid formulations for oral administration are suspensions, solutions, emulsions and syrups, and the above-mentioned formulations can contain various excipients such as wetting agents, sweeteners, aromatics and preservatives in addition to generally used simple diluents such as water and liquid paraffin. For formulations for parenteral administration, powders, granules, tablets, capsules, sterilized suspensions, liquids, water-insoluble excipients, suspensions, emulsions, syrups, suppositories, external use such as aerosols and sterilized injections can be prepared by the conventional method, and preferably skin external pharmaceutical compositions such as creams, gels, patches, sprays, ointments, plasters, lotions, liniments, pastes or cataplasms can be prepared, but not always limited thereto. Water insoluble excipients and suspensions can contain, in addition to the active compound or compounds, propylene glycol, polyethylene glycol, vegetable oil like olive oil, injectable ester like ethylolate, etc. Suppositories can contain, in addition to the active compound or compounds, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin, etc. The present invention also provides a method for screening a TRPA1 activity inhibitor comprising the following steps: 1) constructing a transformant by transfecting a host cell with a plasmid harboring the polynucleotide encoding TRPA1; 2) treating the transformant with TRPA1 specific activator and TRPA1 activity inhibitor candidates as the experimental group, and treating the transformant with TRPA1 specific activator and isopentenyl pyrophosphate as the control; 3) measuring TRPA1 ion channel activities in the experimental group and in the control group of step 2); and 4) comparing the results of step 3) and selecting TRPA1 activity inhibitor candidates from the experimental group that demonstrated lower or similar TRPA1 ion channel activity, compared with the control. In a preferred embodiment of the present invention, it was confirmed that TRPA1 activity induced by cinnamaldehyde known as a TRPA1 specific activator was inhibited by isopentenyl pyrophosphate dose-dependently (see FIGS. 1 and 2 ). It was also confirmed that isopentenyl pyrophosphate was inhibited TRPA1 mediated pain in animal models (see FIG. 3 ). Therefore, the said isopentenyl pyrophosphate can be effectively used for the screening of a TRPA1 activity inhibitor. The host cell herein is preferably any cell line that can be used for the study of calcium channel activity and high throughput screening, for example HEK, CHO, HeLa, and RBL-2H3, but not always limited thereto. The TRPA1 specific activator of step 2) is cinnamaldehyde or acetaldehyde. The measuring of ion channel activity of step 3) can be performed by whole cell voltage clamp technique or calcium imaging. The preferable concentration of isopentenyl pyrophosphate is 0.1-100 μM. The preferable concentration of isopentenyl pyrophosphate is 10-100 μM. In a preferred embodiment of the present invention, the TRPA1 inhibitor was confirmed to inhibit TRPA1 activity at micro-molar concentration range (see FIG. 2 ). The present invention also provides a method for inhibiting pain containing the step of administering a pharmaceutically effective dose of isopentenyl pyrophosphate to a subject. In a preferred embodiment of the present invention, it was confirmed that isopentenyl pyrophosphate inhibited TRPA1 mediated pain in animal models (see FIG. 3 and FIG. 4 ). So, the said isopentenyl pyrophosphate can be effectively used as a composition for inhibiting pain. The pain herein is mediated by TRPA1 activity. The subject herein is one of vertebrates and preferably mammals and more preferably selected from such test animals as rats, rabbits, guinea pigs, hamsters, dogs and cats, and most preferably apes such as chimpanzees and gorillas. The composition of the present invention can be administered orally or parenterally. For example the possible administration pathway can be oral administration, rectal administration, intravenous injection, intramuscular injection, hypodermic injection, intrauterine injection or intracerebroventricular injection. The composition for inhibiting pain of the present invention can be administered alone or treated together with surgical operation, hormone therapy, chemo-therapy and biological regulators. The effective dosage of the composition of the present invention can be determined by those in the art according to condition and weight of a patient, severity of a disease, type of a drug, administration pathway and duration. Preferably, the composition of the present invention can be administered by 0.0001-100 mg/kg per day, and more preferably by 0.001-100 mg/kg per day. The administration frequency is once a day or a few times a day. The composition for inhibiting pain can include, in addition to isopentenyl pyrophosphate, one or more effective ingredients having the same or similar function to isopentenyl pyrophosphate. The composition of the present invention preferably includes isopentenyl pyrophosphate by 0.0001-10 weight % and more preferably 0.001-1 weight % for the total weight of the composition. The composition of the present invention can additionally include generally used carriers, excipients, disintegrating agents, sweetening agents, lubricants, flavors and diluents. The carriers, excipients and diluents are exemplified by lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. The disintegrating agent is exemplified by sodium carboxy methyl starch, crospovidone, croscarmellose sodium, alginic acid, calcium carboxymethyl cellulose, sodium carboxymethyl cellulose, chitosan, guar gum, low-substituted hydroxypropyl cellulose, magnesium aluminum silicate, polacrilin potassium, etc. The composition for inhibiting pain of the present invention can be provided as a pharmaceutical composition. The pharmaceutical composition of the present invention can additionally include a pharmaceutically acceptable additive, which is exemplified by starch, gelatinized starch, microcrystalline cellulose, lactose, povidone, colloidal silicon dioxide, calcium hydrogen phosphate, lactose, mannitol, taffy, Arabia rubber, pregelatinized starch, corn starch, cellulose powder, hydroxypropyl cellulose, Opadry, sodium carboxy methyl starch, carunauba wax, synthetic aluminum silicate, stearic acid, magnesium stearate, aluminum stearate, calcium stearate, white sugar, dextrose, sorbitol, talc, etc. The pharmaceutically acceptable additive herein is preferably added by 0.1-90 weight part to the pharmaceutical composition. The composition for inhibiting pain of the present invention can be provided as a composition for health food. Isopentenyl pyrophosphate of the present invention can be used as food additive. In that case, isopentenyl pyrophosphate can be added as it is or as mixed with other food components according to the conventional method. The mixing ratio of active ingredients can be regulated according to the purpose of use (prevention or health enhancement). In general, to produce health food or beverages, isopentenyl pyrophosphate is added preferably by 0.2-20 weight % and more preferably by 0.24-10 weight %. However, if long term administration is required for health and hygiene or regulating health condition, the content can be lower than the above but higher content can be accepted as well since isopentenyl pyrophosphate has been proved to be very safe. The health food of the present invention can additionally include various flavors or natural carbohydrates, etc, like other beverages. The natural carbohydrates above can be one of monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, and glucose alcohols such as xilytole, sorbitol and erythritol. Besides, natural sweetening agents such as thaumatin and stevia extract, and synthetic sweetening agents such as saccharin and aspartame can be included as a sweetening agent. The content of the natural carbohydrate is preferably 0.01-0.04 weight part and more preferably 0.02-0.03 weight part in 100 weight part of the health food of the present invention. The food herein is not limited. For example, isopentenyl pyrophosphate of the present invention can be added to meat, sausages, bread, chocolates, candies, snacks, cookies, pizza, ramyuns, flour products, gums, dairy products including ice cream, soups, beverages, tea, drinks, alcohol drinks and vitamin complex, etc, and in wide sense, almost every food applicable in the production of health food can be included. In addition to the ingredients mentioned above, the health food of the present invention can include in variety of nutrients, vitamins, minerals, flavors, coloring agents, pectic acid and its salts, alginic acid and its salts, organic acid, protective colloidal viscosifiers, pH regulators, stabilizers, antiseptics, glycerin, alcohols, carbonators which used to be added to soda, etc. The health food of the present invention can also include natural fruit juice, fruit beverages and/or fruit flesh addable to vegetable beverages. All the mentioned ingredients can be added singly or together. The mixing ratio of those ingredients does not matter in fact, but in general, each can be added by 001-0.1 weight part per 100 weight part of the health food of the present invention. Practical and presently preferred embodiments of the present invention are illustrative as shown in the following Examples, Experimental Examples and Manufacturing Examples. However, it will be appreciated that those skilled in the art, on consideration of this disclosure, may make modifications and improvements within the spirit and scope of the present invention. Example 1 Construction of Cell Lines Transfected with TRPA HEK293T cell line (ATCC CRL-11268) was transiently transfected with plasmid DNA containing polynucleotide encoding rTRPA1 (SEQ. ID. NO: 1). Particularly, the HEK293T cell line was transiently transfected with 3 μg/35 mm dish of pcDNA5/FRT vector containing polynucleotide encoding mTRPA1, and 600 ng/well of pCDNA3 (Invitrogen Corp., USA; containing green fluorescent protein (GFP) cDNA) using Fugene6 (Roche Diagnostics, USA) according to manufacturer's instruction. The transformed cells were cultured in DMEM/F12 medium containing 10% FBS and 1% penicillin/streptomycin in a CO 2 incubator for 24 hours. The cells were smeared on poly-L-lysine-coated glass coverslips, followed by further culture for 10-24 hours. Example 2 Statistical Treatment All the results of examples were statistically analyzed by two-tailed, unpaired Student's-t-test and the results were presented by mean±S.E.M. (**p<0.01, and *p<0.05). Example 3 TRPA1 Activity Inhibition by TRPA1 Inhibitor <3-1> Treatment of Compounds The mTRPA1 transfected cell line (n=73) prepared in Example 1 was treated with 300 μM of cinnamaldehyde (CA; MP Biomedicals, USA), during which 100 μM of isopentenyl pyrophosphate (Biomol, USA) was treated for a certain period of time. Stock solutions were made using water or ethanol, and were diluted with test solutions before use. <3-2> Measurement of Intracellular Calcium Level Changes by Calcium Imaging Calcium imaging was performed with the transfected cell line treated by the method of Example <3-1>. Particularly, the transfected cell line of Example <3-1> was loaded with Fluo-3AM (5 μM; Sigma Aldrich, USA) in the bath solution (140 mM NaCl, 5 mM KCl, 2 mM CaCl 2 , 1 mM MgCl 2 , 10 mM HEPES; adjusted to pH 7.4 with NaOH) containing 0.02% pluronic acid (Invitrogen, USA) at 37° C. for 1 hour. Calcium imaging was performed with LSM5 Pascal confocal microscope (Carl Zeiss, Germany), and time-lapse images (excitation 488 nm/emission 514 nm) were collected every 3 seconds using Carl Zeiss ratio tool software (Carl Zeiss, Germany). Mean value curve of calcium influx responses was made by Hill plot. As a result, as shown in FIG. 1 , TRPA1 activity induced by cinnamaldehyde was inhibited by isopentenyl pyrophosphate. Example 4 TRPA1 Activity Over TRPA1 Inhibitor Concentration The TRPA1 transfected cell line (n=73-127) prepared in Example 1 was treated with 300 μM of CA and 1, 10 and 100 μM of isopentenyl pyrophosphate. Calcium imaging was performed with the transfected cell line. As a result, as shown in FIG. 2 , TRPA1 activity induced by cinnamaldehyde was inhibited by isopentenyl pyrophosphate in the mTRPA1 cell line dose-dependently. Example 5 Pain Relieving Response by TRPA1 Inhibitor Examined by Animal Test <5-1> Inducement of Inflammatory Sensitization Inflammatory sensitization by isopentenyl pyrophosphate was investigated. Particularly, 50 μl of 1% carrageenan (CAR, Sigma Aldrich, USA) was injected to the right hind paws of mice 3 hours before the isopentenyl pyrophosphate injection or 10 μl of CFA (complete Freund's adjuvant; Sigma Aldrich, USA) was injected 24 hours before the isopentenyl pyrophosphate injection. At this time, 10 mM cinnamaldehyde was diluted in PBS containing 0.5% Tween 80 for injection. Before the experiment, the mice were adapted for one hour to the experimental environment. 10 μl of vehicle (saline containing 3% DMSO and 0.5% Tween 80) alone or 10 μl of vehicle containing isopentenyl pyrophosphate (3 mM) was injected to the right hind paws of the mice. <5-2> Investigation of Acute Licking/Flicking Behaviors The time spent for the hind paw licking/flicking behaviors in mice were measured according to the method of Bandell M, et al. ( Neuron 41:849-857, 2004) and Moqrich A, et al. ( Science 307:1468-1472, 2005), for 10 minutes. Control: non-treatment; Experimental group 1. 100 μM of isopentenyl pyrophosphate; Experimental group 2. 300 μM of CA; Experimental group 3. 300 μM of CA+100 μM of isopentenyl pyrophosphate; Experimental group 4. 50 μl of CAR+300 μM of CA+100 μM of isopentenyl pyrophosphate; and, Experimental group 5. 10 μl of CFA+300 μM of CA+100 μM of isopentenyl pyrophosphate. As a result, as shown in FIG. 3 , unlike isopentenyl pyrophosphate, cinnamaldehyde increased the time spent for the behaviors ( FIG. 3 a ), and co-treatment of cinnamaldehyde and isopentenyl pyrophosphate reduced the time spent for the behaviors ( FIG. 3 b ). When carrageenan or CFA was injected to cause inflammation, the time spent for the behaviors which had been increased by cinnamaldehyde was also reduced by isopentenyl pyrophosphate ( FIG. 3 c ). The result of 10 minute-reaction induced in animals was also consistent with the result shown in FIG. 3 d. In addition, when CAR and CFA alone were injected and when isopentenyl pyrophosphate alone was treated, the time spent for the behaviors was not increased (no data). <5-3> Analysis of Sensitivity to Thermal Stimulation To investigate inhibition of inflammatory sensitization induced by isopentenyl pyrophosphate, 10 μl of 0.1% carrageenan (CAR; Sigma Aldrich, USA) was injected into the right hind paws of mice three hours before the isopentenyl pyrophosphate injection. 10 μl of isopentenyl pyrophosphate was injected into the experimental group at the concentration of 1 mM. Equal amount of AP18 (Biomol, USA), the TRPA1 specific inhibitor, was injected into the positive control. Avoidance time was measured by using thermal stimulator (Ugo basile plant test, Italy). Each group was composed of 5 mice and beam injection was performed four times, which were averaged. As a result, as shown in FIG. 4 , the mice injected with carrageenan were more sensitive to thermal stimulation than the mice not-treated. In the meantime, the mice co-treated with carrageenan and isopentenyl pyrophosphate (IPP) of the present invention demonstrated significantly reduced sensitivity against thermal stimulation. Particularly, AP18 known as a TRPA1 specific inhibitor exhibited almost no effects. On the other hand, isopentenyl pyrophosphate of the present invention demonstrated significant effect, suggesting that it had excellent pain relieving effect, compared with the conventional TRPA1 inhibitors. The Manufacturing Examples of the composition for the present invention are described hereinafter. Manufacturing Example 1 Preparation of Pharmaceutical Formulations <1-1> Preparation of Powders Isopentenyl pyrophosphate 2 g Lactose 1 g Powders were prepared by mixing all the above components, which were filled in airtight packs according to the conventional method for preparing powders. <1-2> Preparation of Tablets Isopentenyl pyrophosphate 100 mg Corn starch 100 mg Lactose 100 mg Magnesium stearate  2 mg Tablets were prepared by mixing all the above components by the conventional method for preparing tablets. <1-3> Preparation of Capsules Isopentenyl pyrophosphate 100 mg Corn starch 100 mg Lactose 100 mg Magnesium stearate  2 mg Capsules were prepared by mixing all the above components, which were filled in gelatin capsules according to the conventional method for preparing capsules. <1-4> Preparation of Pills Isopentenyl pyrophosphate   1 g Lactose 1.5 g Glycerin   1 g Xylitol 0.5 g Pills were prepared by mixing all the above components according to the conventional method for preparing pills. Each pill contained 4 g of the mixture. <1-5> Preparation of Granules Isopentenyl pyrophosphate 150 mg Soybean extract  50 mg Glucose 200 mg Starch 600 mg All the above components were mixed, to which 100 mg of 30% ethanol was added. The mixture was dried at 60° C. and the prepared granules were filled in packs. Manufacturing Example 2 Preparation of Dairy Products 5˜10 weight part of isopentenyl pyrophosphate of the present invention was added to milk. Health enhancing dairy products such as butter and ice cream were prepared with the milk mixture according to the conventional method. Manufacturing Example 3 Preparation of Beverages <3-1> Preparation of Health Beverages Isopentenyl pyrophosphate 1000 mg Citric acid 1000 mg Oligosaccharide 100 g Maesil ( Prunus mume ) Extract 2 g Taurine 1 g Purified water up to 900 Ml The above constituents were mixed according to the conventional method for preparing health beverages. The mixture was heated at 85° C. for 1 hour with stirring and then filtered. The filtrate was loaded in 2 liter sterilized containers, which were sealed and sterilized again, stored in a refrigerator until they would be used for the preparation of a composition for health beverages. The constituents appropriate for favorite beverages were mixed according to the preferred mixing ratio but the composition ratio can be adjusted according to regional and national preferences, etc. Those skilled in the art will appreciate that the conceptions and specific embodiments disclosed in the foregoing description may be readily utilized as a basis for modifying or designing other embodiments for carrying out the same purposes of the present invention. Those skilled in the art will also appreciate that such equivalent embodiments do not depart from the spirit and scope of the invention as set forth in the appended Claims.

The present invention relates to a TRPA1 activation inhibitor, more precisely a TRPA1 activity inhibitor containing isopentenyl pyrophosphate and a method for inhibiting pain containing the step of administering isopentenyl pyrophosphate to a subject. Isopentenyl pyrophosphate of the present invention can regulate pain caused by TRPA1, so that it can be effectively used for the development of a pain inhibitor which is effective but has less side effects.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application No. 62/000,182 filed May 19, 2014, the entire disclosure of which is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention generally relates to endotracheal tubes. More specifically, the present invention relates to a method and apparatus for more accurately determining the optimal endotracheal tube size for safe and effective intubation and airway maintenance of any individual patient requiring placement of an endotracheal tube. BACKGROUND OF THE INVENTION [0003] When a patient is unable to breathe on his or her own due to a critical illness or injury, it becomes necessary for a clinician to place an endotracheal tube (also referred to herein as “ETT”) into that patient's trachea to facilitate the patient's breathing. Similarly, when a patient is unable to breathe independently because s/he is under general anesthesia for surgery, it becomes necessary for a clinician to place an endotracheal tube into that patient's trachea to sustain the patient's breathing. [0004] When preparing to manage a patient's airway, it is important to determine the correct size endotracheal tube for any individual patient for several reasons. As discussed in greater detail below, two parameters are critical—tube diameter and tube length. Tube diameter is measured relative to the narrowest diameter of the upper airway, the cricoid ring. However, the glottic aperture, a triangular shaped opening to the trachea, is defined by the true vocal cords and arytenoid cartilage and is located just proximal to the cricoid ring. The glottic aperture can be measured and the diameter of the cricoid ring can then be calculated. Tube length is measured relative to the distance between the patient's vocal cords and the carina of the trachea (a cartilaginous ridge within the trachea that runs antero-posteriorly between the two primary brochi at the site of the tracheal bifurcation at the lower end of the trachea). [0005] For purposes of reference, two oppositely disposed ends of a tube shall be referred to as the machine end and the patient end, the machine end being the end that remains outside a patient's mouth for connection to a ventilation source (i.e. bag valve mask or mechanical ventilator), and the patient end being the end that is placed into the trachea. Also, for purposes of reference, the trachea can be divided into three theoretical zones. Zone 1 will be referred to as the Upper Trachea—Unsafe Positioning Zone. It is 3.1 cm long and is made up of the 1 cm long cricoid ring immediately below the vocal cords and a 2.1 cm length of the trachea. Research shows that if the machine end of the endotracheal tube cuff (balloon) encroaches on this region, increased risk arises for recurrent laryngeal nerve impingement or pressure directly applied to the vocal cords, either of which may lead to an increased risk for vocal cord injury and paralysis. Encroachment on this region also leads to an increased risk for unplanned extubation. Zone 2 is the Lower Trachea—Unsafe Positioning Zone. It is 2.0 cm long and if the tip of the tube encroaches on this region, an increased risk for endobronchial mal-positioning and associated complications arises. Zone 3 is the Safe Positioning Zone and lies between Zones 1 and 2 . [0006] If an endotracheal tube having too large a diameter (relative to the patient's glottic aperture) is placed through the glottic aperture, the force applied to the vocal cords may cause a subluxation or dislocation of the crico-arytenoid joints leading to vocal cord dysfunction. Too small a diameter tube may lead to air leaks and inadequate ventilation of the patient. Similarly, if an endotracheal tube whose length from the tip of the tube at the patient end (T) to the machine end of the balloon or endotracheal tube cuff (B ME ) (illustrated as T-B ME in FIG. 1 ) is too long relative to the length of the patient's tracheal Safe Positioning Zone, either the tip of the tube will encroach on the Lower-Trachea Unsafe Positioning Zone or the machine end of the inflated balloon will encroach on the Upper Trachea—Unsafe Positioning Zone. All of these conditions place the patient at risk for a number of complications arising from tube mal-positioning including pulmonary atelectasis, hypoxemia, pneumonia, pneumothorax, vocal cord injury, vocal cord paralysis, brain injury and death. To safely place an endotracheal tube in the proper position of the trachea, both the tip of the tube and the balloon must be positioned completely within the patient's Safe Positioning Zone. [0007] Both the outside diameter (OD) of the tube relative to the diameter of the glottic aperture and the (T-B ME ) length of the endotracheal tube relative to the length of the Safe Positioning Zone should be known when determining the size of endotracheal tube that will be used to intubate a patient to minimize complications of endotracheal intubation and airway maintenance. Historically, however, endotracheal tube sizes and identification nomenclatures have been based solely upon the interior diameter (ID) of the endotracheal tube. Although it is important for the physician to determine the correct endotracheal tube size for every individual patient, most clinicians responsible for the intubation determine endotracheal tube size based upon an educated guess, rather than upon scientific formula, algorithm or accurate measurement of any kind. Some practitioners will choose to place a 7.5 mm endotracheal tube for all females and an 8.0 mm endotracheal tube for all males. Some will choose a 7.0 mm tube for small adults, a 7.5 mm tube for medium size adults and an 8.0 mm tube for large adults. Others may just get a so-called “feel” for the “appropriate” size tube they think a person may need based on their physical characteristics such as height, weight and general size appearance. No generally accepted and widely utilized method, formula, or system exists that maximizes the probability of choosing the optimally-sized endotracheal tube for adults. [0008] In contrast, certain formulas and methods exist that are generally accepted and used by clinicians to calculate the “proper” size tube for insertion into neonates, infants and children. One generally accepted formula based on the age of the child is given as (ETT Size=4+ age in years/4), and both weight-based and length-based systems are generally accepted and utilized to choose tube sizes in neonates, infants and children. However, even the weight and length-based systems that are considered the gold standard methods for choosing pediatric size tubes use indirect measures (weight/length) that do not correlate highly to nor predict well the tracheal length and glottic opening diameter and, thus, are not great predictors of optimal tube size. [0009] As noted above, the size of an endotracheal tube is currently defined based on the inside diameter (I.D.) of the tube. Tube sizes range from a size 2.5 mm I.D. to a 10.5 mm I.D in 0.5 mm increments. However, endotracheal tubes with the same inside diameter (I.D.), have varying outside diameters (O.D.) depending upon the manufacturer and tube type. For instance, the Rusch 7.5 mm Standard ETT has an O.D. of 10.0 mm; the Mallinckrodt 7.5 mm Standard ETT has an O.D. of 10.2 mm; the Mallinckrodt 7.5 mm Hi-Lo Evac ETT has an O.D. of 11.2 mm; and the Teleflex 7.5 mm and the ISIS ETT each have an O.D. of 11.3 mm. [0010] The International Organization for Standardization (ISO) requires that both the inside diameter (I.D.) and outside diameter (O.D.) be clearly marked on every endotracheal tube. Despite this reference to the outside diameter, most clinicians do not consider the outside diameter marking on the tube to determine the size of tube that will be utilized for any individual patient. [0011] The ratio of the outside diameter of the endotracheal tube relative to the glottic aperture must be considered in order to minimize the risk for vocal cord injury. This ratio should be less than one. Preferably, the largest diameter endotracheal tube possible (which will minimize the “work of breathing”) should be used while not placing a tube so large that it causes significant pressure on the vocal cords or dislocation of the arytenoid cartilages (leading to vocal cord dysmobility). Ensuring that the diameter of the ETT is smaller than the diameter of the glottic aperture will decrease the risk of vocal cord paralysis from arytenoid cartilage dislocation and other complications as noted hereinabove. [0012] Historically in determining tube size based upon the diameter of the tube, the assumption is made that if the appropriate diameter tube is chosen, the appropriate length of tube automatically follows. However, determination of optimal endotracheal tube size for any individual patient should be based upon considerations of both diameter and length. More specifically, the clinician should consider not only the outside diameter of the ETT relative to the size of the patient's glottic aperture, but also should consider the T-B ME length relative to the VC-C length. The VC-C length is defined as the distance from a patient's vocal cords to the patient's tracheal carina. Every patient, based on his or her tracheal length, has a Safe Positioning Zone within the trachea, which defines the region within which both the endotracheal tube tip and balloon must be positioned. [0000] TABLE 1 ISO Standard for Max T-B me Distance (Dmax) I.D. (mm) Dmax (mm) 2.0 — 2.5 — 3.0 — 3.5 — 4.0 — 4.5 — 5.0 56 5.5 56 6.0 58 6.5 62 7.0 66 7.5 69 8.0 72 8.5 75 9.0 78 [0013] In an attempt to protect patients from vocal cord injury from tubes whose T-B ME length is too long, ISO Standard 5361-1999 dictates to manufacturers the maximum allowable distance (D MAX ) from the tip of the patient end of an endotracheal tube to the machine end of the inflatable length of the tube's balloon. The ISO Standard D MAX for all size tubes is shown in Table 1. Because the maximum distance rather than the exact distance is defined in the ISO standard, this distance may vary for the same size tube from one manufacturer to another. The ISO Standard simply controls the T-B ME length for a given diameter tube. However, even if the clinician chooses a tube having the correct diameter tube, the T-B ME length may still be too long, despite ISO standards. [0014] In order to assist clinicians in placing an endotracheal tube at the correct depth, many manufacturers place a depth localizer band or marker on their endotracheal tubes. The depth localizer bands indicate the position of the tube that should be placed at the level of the vocal cords. Although ISO standards permit depth localizer markers on endotracheal tubes to provide assistance in positioning the tracheal tube within the trachea, no specific standards exist for the placement of these bands on the tube body. Moreover, no standards exist for determining VC-T distances for different size (I.D.) tubes. [0015] As shown in FIG. 2 , when the proper size (length) endotracheal tube is placed with the localizer band at the vocal cords, the tip of the tube as well as the entire balloon should be within the Safe Positioning Zone 46 . This Safe Positioning Zone preferably places the tip (patient end of the tube) at least 2 cm above the carina to minimize the risk of endobronchial positioning of the tube, should the tube move either due to inadequate stabilization or due to flexion/extension of the patient's neck. It also preferably places the machine end of the inflated balloon at least 3.1 cm below the vocal cords, thus minimizing the risk of impingement of the recurrent laryngeal nerve and vocal cords as well as minimizing the risk of unplanned extubation. [0016] Ensuring that both the tip of the tube and the entire balloon are within the Safe Positioning Zone of the trachea will minimize the risk of complications due to mal-positioning of the tube either at the time of placement of the tube or subsequently should any movement of the tube occur. If any of the T-B ME complex is too deep, the patient is at increased risk for endobronchial intubation and any of its inherent complications including hypoventilation, hypoxemia, pneumonia, and pneumothorax. If the T-B ME complex is too shallow, the patient is at increased risk for the inflatable balloon impinging on the recurrent laryngeal nerve and/or vocal cords and the inherent complications of vocal cord paralysis. In addition, if the T-B ME complex is too shallow, the patient is at increased risk for unplanned extubation and its inherent potentially deadly complications including vocal cord injury/paralysis, aspiration pneumonia, hypoxemia, brain injury and death. [0017] The length of the trachea, from the upper end at the cricoid ring to the lower end at the carina varies in adults from approximately 10 cm to 15 cm with the average adult trachea measuring approximately 12.5 cm. FIG. 3 illustrates the importance of the VC-T and T-B ME distances when an endotracheal tube is placed. As shown in FIG. 3 , a 7.5 mm ETT is positioned with the depth localizer bands at the vocal cords in ( 3 A) a short trachea (10 cm), ( 3 B) an average trachea (12.5 cm) and ( 3 C) a long trachea (15 cm). Note that both the tip and the entire balloon of the 7.5 mm tube is within the Safe Positioning Zone 46 in both (c) the long trachea (15 cm) and (b) the average trachea (12.5 cm). However, it is outside the Safe Positioning Zone 46 and at risk for endobronchial mal-positioning in (a) the short trachea (10 cm). [0018] As shown in FIG. 4 , when a 7.5 mm ETT is positioned in a patient with a short 10 cm trachea based upon the manufacturer depth localizer band properly placed at the vocal cords, the tip of the tube is noted to be too deep and is well within the Lower Trachea—Unsafe Positioning Zone, putting the patient at increased risk for endobronchial mal-positioning. If once the tip is noted to be too deep and the ETT is withdrawn several centimeters so that the tip of the tube is within the Safe Positioning Zone 46 , then the machine end of the balloon encroaches on the Upper Trachea—Unsafe Positioning Zone, putting the patient at increased risk for impingement of the vocal cords and laryngeal nerve and increased risk for unplanned extubation. Therefore, a 7.5 mm ETT, manufactured under current diameter driven specifications, cannot be properly placed in any patient with a short trachea (10 cm) without putting the patient at increased risk for complications. Moreover, the diagrams in FIG. 5 illustrate that an individual with a short trachea (10 cm) cannot accommodate a tube larger than a 6.0 mm ( FIG. 5D ) with both the tube tip and balloon completely within the Safe Positioning Zone 46 . Accordingly, the actual length of a patient's trachea should be determined to ensure that a tube with the correct lengths (VC-T and T-B ME ) is utilized and the length consideration should be separate from the diameter considerations discussed earlier. [0019] In view of the foregoing, it will be apparent to those skilled in the art from this disclosure that a need exists for an improved method and apparatus for determining the optimal endotracheal tube size for safe intubation of a patient to minimize the risk for mal-positioning of the endotracheal tube and the complications associated therewith and that the optimal tube size must be based upon both tube diameter relative to the narrowest portion of the upper airway and length from the tip to the machine end of the balloon relative to the length of the patients trachea and Safe Position Zone. Moreover, a need exists for a method and device that accurately determines the limiting diameter of the patient's upper airway (cricoid ring/glottic aperture) as well as the length of the patient's trachea. SUMMARY OF THE INVENTION [0020] In order to achieve the above-mentioned objectives and other objects of the present invention, a method and an apparatus are provided to determine optimal endotracheal tube size based upon both an optimal tube length and optimal tube diameter for any individual patient requiring intubation therewith. [0021] The above method and apparatus utilize a measurement device to determine the smallest diameter of a patient's airway by measuring the glottic aperture and then algorithmically determining the limiting diameter of the airway in order to determine the optimal outer diameter of the tube for any individual patient. [0022] In one embodiment of the present invention, a measurement device may utilize indirect methods for determining the glottic aperture such as optical scanning, ultrasound, or any other indirect methods to measure the limiting diameter of the upper airway. The device may scan the glottic aperture and thereby determine the diameter of the opening of the glottis. The device may also scan the cricoid arch and measure the subglottic transverse diameter [0023] In an embodiment, the measurement device may also utilize methods to directly measure the glottic aperture such as a ring mandrel-type device directly deployed into the glottic aperture and cricoid arch. [0024] In another embodiment, in addition to determining optimal tube diameter, a method and apparatus are provided which utilize a measuring device to determine the length of a patient's trachea and then algorithmically determine the optimal tube length for any individual patient. The measurement device employs indirect methods for determining the tracheal length such as ultrasound or other scanning devices. It may utilize associated external anatomical measurements to algorithmically determine the tracheal length, and it may employ direct measurement techniques that deploy a measuring tube directly into the trachea to determine the length thereof in a particular patient. [0025] In an embodiment, an algorithm may be used with a machine, a processor or a computer to determine optimal endotracheal tube size by combining input data from demographics, by way of example, age, height, weight, and/or other anatomical measures, glottic diameter scan, subglottic transverse diameter scan and tracheal length scan. [0026] In yet another embodiment, an apparatus is provided that includes a maneuverable arm, a fiber optic video guidance system and an introducer guide to maneuver an end of the apparatus around obstructions in a patient with a difficult airway to facilitate insertion of either an optimally sized ETT or a standard ETT into the patient's airway. [0027] These and other objects of the present invention will become apparent to those skilled in the art from the following detailed description of preferred embodiments taken in conjunction with the accompanying drawings, figures and tables and by reference to the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0028] Referring now to the attached drawings which form a part of this original disclosure: [0029] FIG. 1 is a side elevation view of an endotracheal tube (“ETT”) illustrating the relative distances: 1. from a depth positioning marker on the tube (the position of the tube defined by the manufacturer that should be placed at the level of the vocal cords) to the tip of the patient end of the ETT (VC-T); and 2. the distance from the tip of the tube to the machine end of an inflatable balloon positioned on the tube (T-B ME ); [0030] FIG. 2 is a side elevation view of an endotracheal tube situated with the tracheal anatomy of a patient, illustrating a Safe Positioning Zone and at least two Unsafe Positioning Zones. [0031] FIG. 3A is a side elevation view of a 7.5 mm ETT positioned in the tracheal anatomy of an adult patient having a short tracheal length (approximately 10 cm) illustrating potential dangerous mal-positioning of the ETT tip in the short trachea; [0032] FIG. 3B is a side elevation view of a 7.5 mm ETT positioned in the tracheal anatomy of an adult patient having an average tracheal length; [0033] FIG. 3C is a side elevation view of a 7.5 mm ETT positioned in the tracheal anatomy of an adult patient having a longer than average tracheal length (15 cm); [0034] FIG. 4A is a side elevation view of a 7.5 mm ETT positioned in a short (10 cm) trachea of a patient illustrating that an endotracheal tube that is too long for the length of a patient's trachea may result in the tip thereof being in an unsafe positioning zone; [0035] FIG. 4B is a side elevation view of the 7.5 mm ETT placed in FIG. 4A repositioned so that the ETT tip is within the safe positioning zone demonstrating, however, that the repositioning results in the machine end of the balloon encroaching on the upper Unsafe Positioning Zone. [0036] FIG. 5A is a side elevation view of a 7.5 mm endotracheal tube positioned in a patient with a 10 cm trachea so that the tip of the ETT is just inside the Safe Positioning Zone. The machine end of the balloon encroaches on the Upper Unsafe Positioning Zone demonstrating that a 7.5 mm endotracheal tube cannot be safely positioned in a patient with a 10 cm trachea. [0037] FIG. 5B is a side elevation view of a 7.0 mm endotracheal tube positioned in a patient with a 10 cm trachea so that the tip of the ETT is just inside the Safe Positioning Zone. The machine end of the balloon encroaches on the Upper Unsafe Positioning Zone demonstrating that a 7.0 mm endotracheal tube cannot be safely positioned in a patient with a 10 cm trachea. [0038] FIG. 5C is a side elevation view of a 6.5 mm endotracheal tube positioned in a patient with a 10 cm trachea so that the tip of the ETT is just inside the Safe Positioning Zone. The machine end of the balloon encroaches on the Upper Unsafe Positioning Zone demonstrating that a 6.5 mm endotracheal tube cannot be safely positioned in a patient with a 10 cm trachea. [0039] FIG. 5D is a side elevation view of a 6.0 mm endotracheal tube positioned in a patient with a 10 cm trachea so that the tip of the ETT is just inside the Safe Positioning Zone. The machine end of the balloon is within the Safe Positioning Zone demonstrating that a 6.0 mm endotracheal tube can be safely positioned in a patient with a 10 cm trachea. [0040] FIG. 6 is a diagrammatic view of an UltraSafe Airway Management System Device which includes airway monitoring equipment and an ETT optimal size determination apparatus illustrating the elements thereof in accordance with an embodiment of the present invention; [0041] FIG. 7 is a cross-sectional view of a patient's airway taken immediately above the vocal cords illustrating an optical scanning method of indirect measurement of a patient's glottic aperture in accordance with an embodiment; [0042] FIG. 8A is a diagram of the cricoid cartilage; [0043] FIG. 8B is an ultrasound image of the cricoid cartilage shown in FIG. 8A illustrating an ultrasonic indirect method of measurement of the sub-glottic diameter in accordance with another embodiment of the present invention; [0044] FIG. 9A is a side perspective view of an apparatus for ultrasonic indirect measurement of the length of the trachea shown in position on a patient; [0045] FIG. 9B is an ultrasound scan of a patient's trachea as an example of that which would be produced by the apparatus of FIG. 9A ; [0046] FIG. 10 is a side elevation view of a ring mandrel device deployed over an introducer extending into the cricoid cartilage shown in FIG. 8A illustrating a direct method of measuring a patient's glottic aperture in accordance with an embodiment; [0047] FIG. 11 is a side sectional view of an apparatus for direct measurement of the length of a patient's trachea, as determined by the distance from the vocal cords to the carina (VC-C), by deploying an introducer tube with measuring capabilities in accordance with an embodiment; [0048] FIG. 12A is a side sectional view of portions of an apparatus for intubation of a difficult airway caused by anatomical anomalies and/or obstructions in accordance with an embodiment; [0049] FIG. 12B is a side perspective view of the apparatus of FIG. 12A in accordance with an embodiment; [0050] FIG. 12C is a side elevation view of a fiber optic bundle element of the apparatus of FIGS. 12A and 12B ; [0051] FIG. 12D is a side perspective view of a cartridge element of the apparatus of FIGS. 12A and 12B ; [0052] FIGS. 13A-13E illustrate visually the steps of a method for intubation of a difficult airway using the apparatus of FIGS. 12A-12D ; and [0053] FIG. 14 is a table illustrating graphically optimal ETT sizes as a function of measured vocal cord diameter and measured tracheal length in accordance with an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0054] Selected embodiments of the present invention will now be explained with reference to the drawings. It will be apparent to those skilled in the art from this disclosure that the following descriptions of the embodiments of the present invention are provided for illustration only and not for the purpose of limiting the invention as defined by the appended claims and their equivalents. [0055] Referring now to FIG. 1 , an endotracheal tube (ETT) of typical construction is shown at 10 . The ETT includes a tubular body 12 having a proximal or machine end 14 and a distal or patient end 16 . The distal end 16 includes a beveled tip 18 defined by the most distal part of the bevel to facilitate insertion into a patient's trachea (not shown). The ETT also includes an inflatable endotracheal tube cuff or balloon 20 to provide a seal between the ETT and the trachea after the tube is placed in the trachea, as is known in the art. The cuff or balloon may be adjustably inflated to a preselected pressure of sufficient magnitude to maintain the seal between the tube and the trachea, as will be described in greater detail below. [0056] In accordance with current practice, the size of an endotracheal tube is defined based on the inside diameter (I.D.) of the tube. Tube sizes range from a size 2.5 mm I.D. to a 10.5 mm I.D in 0.5 mm increments, and The International Organization for Standardization (ISO) requires that both the inside diameter (I.D.) and outside diameter (O.D.) be clearly marked on every endotracheal tube. In the ETT shown in FIG. 1 , by way of example, the tube is marked with size 7.5 indicating a 7.5 mm inside diameter. The O.D. size of 10.0 mm is also clearly marked. Depth positioning markers 22 placed on the tubular body by the manufacturer indicate the proper position of the tube at a patient's vocal cords and provide a reference point for measurement of the distance between the vocal cords and the patient end or tip of the tube 18 , that distance being defined herein as VC-T. The distance from the patient end of the tube 18 to the machine end 24 of the inflatable balloon or cuff is indicated and defined by T-B ME . [0057] FIG. 2 illustrates the ETT 10 placed in a patient's trachea shown in cross-section at 30 . The trachea has a proximal or machine end 32 and a distal or patient end 34 from which the right and left bronchial tubes 36 and 38 separate into the patient's left and right lungs respectively at a ridge known anatomically as the carina 40 . The patient's vocal cords or larynx 42 is positioned anatomically at the proximal end 32 of the trachea just above the cricoid cartilage or ring illustrated graphically at 44 . Although not shown in the accompanying drawings, of critical importance to proper positioning of an ETT in an intubated patient is the location of the recurrent laryngeal nerve, the motor nerve to the vocal cords which lies near the cricoid ring. The Safe Positioning Zone 46 , hereinafter sometimes referred to as the “SPZ,” is the region within the trachea that both the tip of the tube and the entire balloon must be positioned to prevent complications of tube mal-positioning. Immediately above the Safe Positioning Zone is a region of increased risk of impingement of the balloon on the recurrent laryngeal nerve and vocal cords designated by the numeral 48 and which will be referred to herein as the Upper Trachea Unsafe Positioning Zone or Upper Trachea UPZ. Additionally, if the balloon is positioned with the Upper Trachea—Unsafe Positioning Zone, the tip of the tube will be located higher in the trachea and therefore closer to the vocal cords such that there is an increased risk of the tube mal-positioning above the vocal cords leading to an unplanned extubation. Immediately below the safe Positioning Zone is the Lower Trachea—Unsafe Positioning Zone 49 or Lower Trachea UPZ, a region of increased risk of endobronchial mal-positioning. [0058] As discussed above, the SPZ 46 places the tip (patient end of the tube) 18 at least 2 cm above the carina 40 to minimize the risk of endobronchial positioning of the tube, should the tube move either due to inadequate stabilization or due to flexion/extension of the patient's neck. Similarly, the SPZ 46 places the machine end of the balloon at least 2 cm below the typical level of the recurrent laryngeal nerve and vocal cords to minimize the risk of both vocal cord injury and unplanned extubation. [0059] Ensuring that both the tip of the tube and the entire balloon are within the Safe Positioning Zone 46 , within the trachea 30 , will minimize the risk of complications due to endobronchial intubation, unplanned extubation and impingement on the vocal cords 42 and recurrent laryngeal nerve lying near the cricoid ring 44 . If the tip of the tube is too deep, the patient is at increased risk for endobronchial intubation and the inherent complications of endobronchial intubation including hypoventilation, hypoxemia, pneumonia, and pneumothorax (a collapsed or partially collapsed lung). If the tip of the tube is too shallow, the patient is at increased risk of the ETT balloon impinging the vocal cords or recurrent laryngeal nerve leading injury, vocal cord dysmobility, speech abnormalities and vocal cord paralysis. If the tip of the tube is too shallow, the patient is at increased risk for unplanned extubation and the inherent complications of unplanned extubation including vocal cord paralysis, aspiration pneumonia, hypoxemia, brain injury and death. [0060] FIGS. 3A-3C illustrate the importance of the VC-T and T-B ME distances and the Safe Positioning Zone, when an endotracheal tube is placed in a patient's airway. The length of the trachea as measured from just below the cricoid ring 44 to the carina 40 varies in adults from approximately 10 cm to approximately 15 cm. This length of the trachea in an average adult measures approximately 12.5 cm. The 7.5 mm ETT 10 illustrated in FIG. 1 is shown positioned with the depth localizer bands 22 at the vocal cords 42 in a short trachea 50 (10 cm), in FIG. 3A , average trachea 52 (12.5 cm) in FIG. 3B , and a long trachea 54 (15 cm) in FIG. 3C . Note that both the tip of the tube 18 and the balloon 20 are within the SPZ 46 in both the long trachea (15 cm) and the average trachea (12.5 cm); however, as shown in FIG. 3A , it is outside the Safe Positioning Zone and at risk for endobronchial mal-positioning in the short (10 cm) trachea 50 . [0061] Referring now to FIGS. 4A and 4B , the situation may be further complicated when a 7.5 mm ETT 10 in a patient with a 10 cm trachea is withdrawn several cms so that the tip 18 is within Safe Positioning Zone 46 . As shown in FIG. 4B , the machine end 24 of the cuff 20 then encroaches on the Upper Trachea UPZ 48 , the region of increased risk for impingement of the vocal cords and laryngeal nerve and increased risk for unplanned extubation. The intuitive solution would be for the clinician to use the next smaller size (7.0 mm) to eliminate the increased risks to the patient. However, as shown in FIGS. 5A-5D , an individual with a short (10 cm) trachea 50 cannot accommodate a tube larger than a 6.0 mm with both the tube tip 18 and the machine end 24 of the balloon within the Safe Positioning Zone 46 . If a tube larger than 6.0 mm is chosen, either the machine end of the tube will encroach on the Upper Trachea UPZ 48 or the tip 18 will encroach on the region of increased risk for endobronchial mal-positioning or Lower Trachea UPZ 49 . This clearly demonstrates that the actual length of a patient's trachea should be determined to ensure that a tube is used which has not only the correct diameter to avoid laryngeal injury, as discussed in greater detail above, but also the correct length (VC-T and T-B ME ) to avoid the complications of tube mal-positioning. [0062] Referring now to FIG. 6 , an endotracheal tube optimal size determination apparatus in accordance with an embodiment of the present invention is shown generally at numeral 60 . The apparatus can be a standalone device used simply to determine the optimal tube size for any patient under consideration for endotracheal intubation, or it can be combined with other critical electrocardiogram (EKG), heart rate (HR) or non-invasive blood pressure (NIBP) monitoring equipment and airway safety monitoring equipment. By way of example and not of limitation, such safety monitoring equipment may include systems for monitoring EtCO 2 (end-tidal CO 2 or the level of carbon dioxide present at the end of an exhaled breath), SaO 2 (the saturation level of oxygen in hemoglobin), and/or apparatus for monitoring and adjusting cuff or balloon pressure such as disclosed in U.S. patent application Ser. No. 13/924,568 filed Jun. 22, 2013 by the inventor of the instant invention. [0063] The apparatus 60 includes various attachments and devices which will be discussed in greater detail below to perform the following functions to carry out the steps of the novel methods of the present invention to ensure that an ETT of both the proper diameter and length is selected for safe intubation of any patient: 1. Indirect measurement of critical anatomical parameters of a patient's tracheal and glottic physiology. a. Ultrasound imaging device scans and measures tracheal length parameters. b. Glottic aperture measurement. 1) Optical scan to measure glottic aperture which may be combined with a fiberoptic video laryngoscope to facilitate determination of ETT size as an integral part of the process of fiberoptic video intubation. 2) Ultrasound imaging scan of the cricoid arch (measures subglottic diameter). 2. Direct measurement of critical anatomical parameters of a patient's tracheal and glottic physiology. a. Introducer placed during intubation process that directly measures tracheal length b. Graduated cone measurement device to directly measure the glottic aperture. [0072] Referring to FIG. 6 , the apparatus 60 includes a portable housing or body 62 structured and arranged to enclose and protect system electronics and analytical software, computers, processors and associated subsystems necessary for performing analyses and algorithmic calculations in response to indirect and direct anatomical measurements as hereinabove described to determine proper ETT size. By way of example, the indirect and/or direct anatomical measurements may be combined with demographically-collected and statistically compiled data such as age, height, weight and anatomical measurements such as tracheal length, glottic diameter, subglottic transverse diameter and the like, and analyzed by the apparatus' analytical systems to determine proper ETT size. [0073] The housing includes a carrying handle 64 secured thereto for ease of transporting the apparatus for field use by aeromedical flight teams and field paramedics. Various scan, test and control dials, selection buttons, input and output connection ports, and readout screens as known in the medical instrumentation art are illustrated generally at 66 . The apparatus 60 includes, by way of illustration and not of limitation, an optical and/or ultrasound scanning device as part of a hand-held intubating video laryngoscope, shown generally at 68 , for generating indirect images for measurement of the glottic aperture during intubation. By way of example and not of limitation, FIG. 7 shows an optical scanning screen image 70 overlaying a glottic aperture 72 formed by the vocal cords 74 and cricoid or arytenoid cartilage 73 . The intubating laryngoscope shown at 68 and described in greater detail in FIGS. 11 and 12 can also use its ultrasound scanning capabilities to measure the length of the vocal cord to carina distance during the intubation process. An ultrasound scanning device 76 is connected to the apparatus for generating indirect images of the cricoid arch for measurement of the subglottic aperture diameter 75 shown in FIG. 8A and for generating indirect ultrasound images of the trachea for measurement of tracheal length. An exemplary indirect image of the cricoid arch and subglottic aperture is shown in FIG. 8B . FIG. 9A shows the ultrasound scanning device 76 positioned on a patient's thoracic area and adapted to measure indirectly via ultrasonic energy the length of the patient's trachea. FIG. 9B is an exemplary indirect ultrasonically generated image of the length of a patient's trachea 78 . [0074] Directing the reader's attention now to FIGS. 10 and 11 , separate devices are shown for direct measurement of critical anatomical parameters of a patient's tracheal and glottic physiology. FIG. 10 illustrates a guide mechanism or introducer 80 adapted to be inserted into a patient's trachea during the measuring and intubation process, as will be discussed in greater detail below. A ring mandrel or graduated cone measurement device 82 is deployed over the introducer 80 and structured and arranged to directly measure the glottic aperture 72 . By way of example and not of limitation, the mandrel or cone may have graduated rings 83 formed therein of predetermined diameters and/or pressure sensors affixed thereto at various intervals to indicate where it engages the glottic aperture to obtain the size thereof. Alternatively, a fiber optic device may be inserted simultaneously and coaxially therewith to obtain a visual reading of the contact point to properly determine the size of the aperture 72 . [0075] To measure the tracheal length directly, an introducer 80 may be inserted via the hand-held intubating video laryngoscope 68 having a video laryngoscope tip or end portion 85 placed during the intubation process that directly measures tracheal length, as best shown in FIG. 11 . Once the video laryngoscope tip 85 is positioned at the vocal cords 74 , the introducer is extended until the end 87 thereof is at the level of the carina 40 . The length of tube that is extended to reach from the vocal cords 72 to the carina 40 is measured by the video laryngoscopic intubator 84 . The introducer 80 may have measurement graduations or markings formed thereon whereby the length of introducer extended to reach the carina 40 may be read through the video laryngoscope. Alternatively, the length of introducer extended from the intubator 84 to reach the carina 40 can be directly measured by the video laryngoscopic intubating device as the introducer tube is extended. [0076] Referring now to FIGS. 12-14 , an apparatus 90 for intubation of a difficult airway, also referred to herein as a difficult airway intubator, is shown. A difficult airway is one that, due to anatomical variations or medical/trauma issues makes passing an endotracheal tube through the glottic aperture “difficult”. Sometimes the difficult airway is of such severity that it makes passage of an endotracheal tube by standard means of intubation nearly impossible. Therefore, the difficult airway intubator 90 of the instant invention is designed to deal with those anatomical anomalies or obstructions caused by medical issues such as tumors or trauma issues such as severe swelling. [0077] As shown in greater detail in FIGS. 12A-D , the difficult airway intubator 90 includes the hand-held intubating video laryngoscope 68 shown in FIG. 6 . The laryngoscope has a handle portion 92 ; a curvilinear blade 96 for insertion into a patient's oral cavity and extension into a patient's posterior pharynx; a flexible intubation arm 98 having a hollow core 99 extending coaxially along the length thereof comprising a series of sections 100 each sequentially connected to one another by a plurality of extensible, rotatable joints 102 ; a fiber optic video/ultrasound bundle 104 , the fiber optic video to aid in visually guiding the intubation arm 98 into the patient's trachea and the ultrasound device used to measure the length of the trachea; a semi-flexible, hollow tube or introducer 80 which can be extended into the trachea, over which an endotracheal tube is placed to be guided into the trachea during intubation as illustrated in FIG. 13 A-E, The hollow portion of the introducer can be connected to an oxygen source and utilized as a oxygen delivery system directly into the trachea during the intubation process. A plurality of controls 94 on the handle manipulate the flexible intubation arm enclosing the coaxially extending fiber optic bundle and the introducer/oxygen delivery tubes so that it can be maneuvered around obstructions which may be present in the patient's oral cavity to allow for a clear view of the patient's vocal cords 74 as best shown in FIG. 13B . The fiber optic bundle is connected through the video laryngoscope handle 92 to the video monitor 60 ( FIG. 6 ) via a fiber optic bundle cable 105 . [0078] In another embodiment, a second fiber optic bundle 101 can be mounted on the curvilinear blade 96 and attached to the video monitor through cable 105 to allow for continuous viewing of the movement of the flexible intubation arm 98 relative to its position in the oral pharynx and vocal cords. The secondary fiber optic video will allow for continued viewing of the vocal cords/intubation arm/introducer even when the primary fiber optic bundle 104 is deployed into the trachea. [0079] In addition, the apparatus 90 of the present invention addresses a problem associated with current intubation devices/methods. Specifically, once the vocal cords are exposed with a video laryngoscope, the endotracheal tube must then be maneuvered separately around the same obstructions with a clinician's right hand while the view of the cords is maintained in the video laryngoscope with the clinician's left hand. The difficult airway intubator 90 herein disclosed solves that problem by incorporating a detachable sterile cartridge 106 having an introducer 80 stored therein and being selectively extendable via controls 94 through handle portion 92 and curvilinear section 96 into the longitudinally extended core 99 of the intubation arm 98 , thereby allowing for manual deployment of an introducer 80 through the tip 103 of the intubator and into the trachea 50 , once the tip is aligned with the glottic aperture. Once the introducer 80 is deployed into the trachea 50 it can be used to guide the endotracheal tube 10 around any obstructions, through the vocal cords and into the trachea. The secondary fiberoptic 101 can be used to view the endotracheal tube passing through the cords and into the trachea. The introducer may also be adapted to deliver oxygen to the patient via a separate tube 109 within the core of the introducer. As the patient is being intubated, oxygen is continuously delivered through the core of the introducer. [0080] In operation, the difficult airway intubator 90 would be introduced into a patient's oral cavity 110 as shown in FIG. 13A . Through fiber optic video visualization of the oral airway, the tip 103 of the intubation arm and flexible portion 98 would be segmentally adjusted and advanced around any obstructions or anatomical anomalies until the tip 103 , is located at the glottic aperture 72 as shown in FIG. 13A . Once the tip 103 is at the glottic aperture 72 an optical scan or ultrasound of the vocal cord diameter can be measured as shown in FIG. 13B . Then the introducer 80 and fiber optic bundle 104 are advanced into the trachea 50 until it reaches the carina 40 , FIG. 13C . With the tip of the introducer 80 at the carina 40 a measure of trachea length can be taken. Once both vocal cord diameter and tracheal length measures are completed the video laryngoscopic intubator 90 is removed leaving the introducer 80 in the trachea, FIG. 13D . An endotracheal tube 10 , of specific size for the individual patient as determined by the vocal cord diameter and tracheal length measures taken previously, is then placed over the introducer 80 and advanced until properly seated in the trachea as shown in FIG. 13E . [0081] In another embodiment, once the introducer is positioned as shown in FIG. 13 C, rather than completely removing the intubator 90 to allow for placement of the endotracheal tube 10 over the end of the introducer, the introducer 80 can be separated from the intubator with the intubator remaining in place. In this manner, the intubator with its secondary fiber optic 101 near the glottic aperture will allow for direct visualization of the ETT as it is passed over the introducer 80 , through the vocal cords 72 and into the trachea 50 . By example, and as illustrated in FIG. 14 , if a patient's vocal cord diameter measured 10.7 mm and their tracheal length measured 13.6 cm, the optimal size determination device would indicate the optimal tube to be a size VVV. This tube would be optimally designed (I.D., O.D., VC-T, T-B ME , and tube length for a patient with the above measurements. General Interpretation of Terms [0082] In understanding the scope of the present invention, the term “configured” as used herein to describe a component, section or part of a device that is constructed to carry out the desired function. In understanding the scope of the present invention, the term “comprising” and its derivatives, as used herein, are intended to be open ended terms that specify the presence of the stated features, elements, components, groups, integers, and/or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers and/or steps. The foregoing also applies to words having similar meanings such as the terms, “including,” “having” and their derivatives. Also, the terms “part,” “section,” “portion,” “member” or “element” when used in the singular can have the dual meaning of a single part or a plurality of parts. Finally, terms of degree such as “substantially,” “about” and “approximately” as used herein mean a reasonable amount of deviation of the modified term such that the end result is not significantly changed. For example, these terms can be construed as including a deviation of at least ±5% of the modified term if this deviation would not negate the meaning of the word it modifies. [0083] While only selected embodiments have been chosen to illustrate the present invention, it will be apparent to those skilled in the art from this disclosure that various changes and modifications can be made herein without departing from the scope of the invention as defined in the appended claims. Furthermore, the foregoing descriptions of the embodiments according to the present invention are provided for illustration only, and not for the purpose of limiting the invention as defined by the appended claims and their equivalents.

A method and apparatus for determining the optimal endotracheal tube size for the intubation of a patient based upon both optimal tube length and optimal tube diameter which are determined by using either direct or indirect measurement devices or techniques to measure the patient's glottis aperture and tracheal length. The apparatus may include a maneuverable arm, a fiber optic video guidance system and an introducer guide to maneuver an end of the apparatus around obstructions in a patient who has a difficult airway to facilitate insertion of either an optimally sized endotracheal tube or a standard endotracheal tube into the patient's airway.

BACKGROUND OF THE INVENTION The present invention relates generally to dental orthopedic correction and, more particularly, to an adjustable, functional and removable orthopedic appliance for correcting dental Class II malocclusions. DESCRIPTION OF THE RELATED ART A Class II malocclusion is defined as the malposition of the maxillary and mandibular teeth so that the lower dental arch is posterior to the upper dental arch resulting in loss of efficiency during movements of the jaw that are essential for mastication. In a Class II, division 1 malocclusion, the upper incisors are protruding and the occlusion is usually evidenced by an excessive overbite of the lower incisors. In a Class II, division 2 malocclusion the upper incisors are tipped lingually and the laterals are flared labially. Class II malocclusions may be corrected utilizing either fixed appliances or functional, removable appliances, or a combination of both. Fixed appliances such as braces, are typically worn an average of 24 to 30 months to correct a Class II malocclusion. Fixed appliances also require either extra-oral force, intramaxillary elastics, or a combination of both to effect a basal maxilla-mandibular change and to eliminate the excessive overbite, overjet or apical base discrepancy. Removable functional appliances may often eliminate the need for extra-oral force or intramaxillary elastics required by fixed appliances. A removable and functional orthopedic appliance corrects a Class II malocclusion by causing the entire mandible, or lower jaw, to move forward, freeing the condyle in the temporal mandibular joint from any possible growth restrictions from the dominant retrusive muscular activity associated with the inherent Class II malocclusion. The forward movement of the mandible is caused by a stretch reflex initiated by introducing the orthopedic appliance into the patient's mouth, causing the muscles to pull the mandible in an anterior direction. Present orthodontic practice utilizes a series of two or more removable functional orthopedic appliances to correct a Class II type of malocclusion. Examples of these devices are commonly known in the orthodontic profession as "Saggital," "Frankel," "Bionater," and "Ortho Redir Corrector" devices. Each successive appliance is elongated along an anterior-posterior medial line relative to the previously used appliance and as the treatment progresses and the mandible more closely aligns with the maxilla, the second or third appliances of the series is used by the patient. With each successive appliance the mandible is repositioned more closely to a correctly aligned state relative to the maxilla while concurrently restricting maxillary forward growth. Adjustable, functional and removable devices have also been proposed which eliminate the need for using two or more of the above-described orthopedic appliances. For example, U.S. Pat. No. 4,433,956 discloses an adjustable, functional and removable orthopedic corrector having an anterior segment and a posterior segment interconnected by two expansion screw assemblies. As treatment of the Class II malocclusion progresses, each of the two expansion screw assemblies are turned, separating the anterior and posterior segments of the corrector with resultant forward movement of the mandible It is necessary, however, to carefully adjust each expansion screw assembly equally to result in the proper correction of the malocclusion. U.S. Pat. Nos. 4,348,179; 3,977,082 and 4,468,196 disclose various other adjustable orthodontic appliances fitting into the palatal cavity of the mouth for treatment of various orthodontic dysfunctions. However, none of these patents proposes a device for the treatment and correction of Class II malocclusions. There is a need for a single orthopedic appliance for correcting Class II malocclusions which eliminates the need for sequentially employing two or more devices. The appliance should be easy to fabricate, comfortable for the user to wear, easily adjustable and effective in the correction of the Class II malocclusions in as short as time possible. The present invention addresses these problems by providing a single, removable, functional, active appliance for use in the full course of treatment and correction of Class II malocclusions. In addition, the appliance of the present invention is relatively comfortable to wear, thereby eliciting a high degree of patient compliance. These and other advantages of the present invention will be apparent from the drawings, discussion, description and claims which follow. SUMMARY OF THE INVENTION The present invention provides an orthopedic appliance for correcting Class II malocclusions comprising a frontal portion configured to engage the mandibular and maxillary frontal arches of the mouth. The frontal portion includes a cavity corresponding to at least a portion of the inner and outer surfaces of the mandibular incisors and which engages the rear surface of the maxillary incisors. Engagement of the mandibular incisors into the cavity over an extended period of time corrects the Class II malocclusion. The frontal portion further includes a pair of ball clasps which engage the front surfaces of the maxillary incisors. The appliance further includes first and second side portions, each configured to engage at least some of the maxillary molars. Each side member includes a retaining clasp for engaging the maxillary molars and securing the device into the palatal cavity of the mouth. The side portions may also include other orthodontic attachments such as distalizing springs and the like to perform other orthodontic corrections. The orthopedic appliance of the present invention further includes adjustment means interconnecting the frontal portion to the first and second side portions. The adjustment means includes a first expansion screw interconnecting the side members and operative to adjust the lateral spacing therebetween and a second expansion screw associated with the frontal member to adjust the anteriorposterior spacing between the frontal portion and the two side portions. In this manner, the present invention provides a single appliance for correcting Class II malocclusions which is easily adjustable in two directions. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of an orthopedic appliance of the present invention; FIG. 2 is a bottom plan view of the orthopedic appliance of FIG. 1 seated in the palatal cavity of a user; and FIG. 3 is a perspective view of the orthopedic appliance of the present invention fitted into a plaster model of a mouth with closed jaws. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings, as is shown in FIG. 1, an orthopedic appliance 10 comprises a frontal portion 12, a first side portion 14 and a second side portion 16, molded to conform to the interior of the patient's mouth. Orthopedic appliance 10 is removably secured in the palatal cavity of a patient's mouth by retentive springs and clasps as will be explained below. The frontal portion 12 is configured to engage at least a portion of the mandibular and maxillary frontal arches when the mouth is closed, while the first and second side portions 14, 16 engage the interior sides of at least some of the maxillary molars. Frontal portion 12, first side portion 14 and second side portion 16 are fabricated from a synthetic polymeric material, preferably a tissue compatible acrylic, using established techniques known in the dental art. In one such technique, a plaster cast from an alginate mold is made of the patient's mouth and dentition in the construction bite position. The construction bite is defined as the amount of forward movement of the mandible and opening of the mandible which the patient self-induces at the doctor's direction prior to treatment. Orthopedic appliance 10 is molded using the shape taken from the plaster cast. Retaining clasps 18, ball clasps 24 and various other orthopedic attachments, such as distalizing springs 22, are placed in the mold at the desired locations and are embedded into place in the acrylic during the molding process. FIGS. 2 and 3 show the orthopedic appliance 10 in place in a plaster model of in the mouth of a 7-year old patient. This patient has not completely lost all of her deciduous or "baby" teeth as will be noted by those skilled in the art. This model is shown as an example only and in no way is meant as a limitation upon the present invention. Although the appliance 10 may be used to correct Class II malocclusions at any stage during a patient's life, the appliance 10 is most favorably used while the patient is actively growing, i.e., at or before puberty. As is particularly illustrated in FIG. 3, the ball clasps 24 are embedded in the frontal portion 12 and act to engage the front surface of the maxillary arch between the central 21 and lateral 23 maxillary incisors. The top of the frontal portion 12 further includes indentations 28 (best seen in FIG. 1) for engaging the rear surfaces of the maxillary incisors 21,23. The bottom of frontal portion 12 includes a cavity 30, as shown in phantom in FIG. 1 and shown more clearly in FIGS. 2 and 3, for receiving at least a portion of the inner and outer surfaces of the central 27 and lateral 29 mandibular incisors as well as the mandibular cuspids 32 therein. The first side portion 14 and the second side portion 16 are molded to conform to the roof of the patient's upper mouth. As shown more clearly in FIG. 2, the first and second side portions 14,16 respectively, include retaining clasps 18, (in this case known as Adams clasps), for engagement with molars 34,36. Retaining clasps 18 and ball clasps 24 cooperate to actively secure orthopedic appliance 10 firmly in the roof of the patient's mouth. This particular feature represents an improvement over prior art devices which utilize tongue position and intimate fit on the upper teeth to hold the appliance in position. In the illustrated embodiment, the first side portion 14 and the second side portion 16 further include molar distalizing springs 22 which are integral in action with the lower jaw advancement bite. As shown in FIGS. 2 and 3, molar distalization springs 22 engage the first permanent (6 year) molars 38 along their exterior surfaces and between the first permanent molars and the adjacent (deciduous or permanent) second 39 molars. Distalizing springs 22 force the first permanent molars to move distally during the treatment of the Class II malocclusions. Various other orthodontic attachments and/or springs for causing buccal, labial, rotational and/or lingual movement of individual teeth may also be molded into appliance 10. Orthopedic appliance 10 further includes adjustment means such as universal screw assembly 20, for altering the spatial relationship between the front 12 and side 14,16 portions. The universal screw assembly 20 may preferably be fabricated from stainless steel, chromium-nickel alloys, non-ferrous metals, or combinations thereof. The universal screw assembly 20 includes a first expansion screw 40 which interconnects the first side portion 14 to the second side portion 16 and operates to adjust the lateral spacing therebetween. The first expansion screw 40 includes an adjuster member 44 containing a plurality of holes 46 for receiving the end of an adjustment tool, such as a small allen wrench key therein. Holes 46 are equidistantly, circumferentially spaced on adjuster member 44 and the pitch of the screw is such that a 90 degree rotation of adjuster member 44 translates into a lateral spacing increase of approximately one-quarter millimeter between the first side portion 14 and the second side portion 16. By utilizing a single adjustment mechanism or expansion screw 40 in this manner, expansion of the device can be easily and accurately adjusted without the need for adjusting two separate screw assemblies as is required in prior art devices. Adjusting the first expansion screw 40 to cause the lateral spacing between the first and second side portions to increase and to increase maxillary arch width. This is a necessary step because, as the upper molars move distally as a result of a molar distalizing springs 22, the maxillary arch width must increase as growth occurs in order to reduce cross bite occurrence. The universal screw assembly 20 includes a second expansion screw 42 which is similar to the first expansion screw 40 in that it also includes an adjuster member 48 having a plurality of adjustment holes 50. As described above with reference to the first expansion screw 40, holes 50 are equally spaced around adjuster member 48 so that the second expansion screw 42 can be adjusted by inserting the tool into the hole and moving it relative to a threaded shaft assembly. As before, a 90 degree rotation of adjuster 48 causes the frontal portion 12 to moVe either posteriorly or anteriorly to the first 14 and second side portions 16, a distance of about one-quarter millimeter. As the second expansion screw 42 is turned in the direction of the arrow, the anterior and posterior segments of the appliance are separated, resulting in forward movement of the mandible. Also, an increase in distance between the frontal portion 12 and the posterior portion 14,16 causes an increase in the upper anterior tooth protrusive guidance as well as movement of the maxillary posterior teeth distally. This upper activation also causes an equal and opposite distalizing effect on the maxillary posterior teeth. Appliance 10 differs from prior art orthopedic appliances in that it moves the upper first permanent molars substantially to the posterior because of the neurologically stimulated anchorage which produces a distalizing, posterior force component in the maxilla equal to the forward stretching, growth stimulating force of the mandibular arch and temporal mandibular joint. The appliance 10 also allows lower posterior alveolar development while holding the lower anterior teeth in position which reduces the usual deep overbite. Mandibular growth and maxillary retraction decrease the amount of original overjet. The construction of the appliance also allows vertical alveolar growth in the posterior parts of the mouth to occur faster and in greater differential to the anterior teeth which are fitted and stabilized in the appliance. This decreases the amount of original overbite. DESCRIPTION OF OPERATION OF THE PREFERRED EMBODIMENT After the orthopedic appliance 10 has been molded to fit the patient's mouth, it is secured against the roof of the patient's mouth by the action of Adams clasps 18 and ball clasps 24 on the teeth and the intimate fit of the appliance. Initially, the orthopedic appliance is adjusted to be retentive only with the mandible forward and the bite open. It should be noted that each patient's treatment is individualized, with some patients being required to wear the device for longer periods of time than other patients. An average treatment period lasts between 6-18 months depending on several factors, including the severity of the malocclusion, the age of the patient, the patient's response to treatment and the patient's cooperation in the counsel treatment. Even in the initially adjusted position, orthopedic appliance 10 is molded so that when the mandible is in a closed position it will be forced forward of its pre-treatment position relative to the maxillary arch. After approximately one month, the molar distalizing springs 22 and expansion screws 40, 42 are activated. Typically, at one month intervals, the patient removes the orthopedic appliance 10, and using a small tool such as the allen wrench or key as described above, turns each expansion screw 40,42 within assembly 20 to effect a posterior-anterior expansion of approximately 1/4 millimeter. Lateral expansion of appliance 10 with screw 40 is performed as needed and directed by the patient's orthodontist. Each successive month for a total of 6-18 months depending upon the patient's response to treatment, the patient turns each expansion screw 40,42 approximately 1/4 millimeter per month, resulting in an aggregate of approximately 11/2-41/2 millimeters of expansion between frontal portion 12 and first and second side portions 14,16. Occasionally, use of the appliance 10 is discontinued for a short period of time, typically 3-6 months, so that the orthodontist can evaluate growth changes in the mandible and maxilla prior to using fixed appliances. The appliance 10 may be used in conjunction with fixed appliances where the malocclusion is especially difficult to treat or where other positional irregularities exist. The gradual expansion of appliance 10 avoids patient discomfort and possible periodontal necrosis and root resorption which might result from an immediate expansion to the maximum extent allowed by expansion screw assemblies 20. When full expansion is reached, the lower jaw or mandible has moved with respect to the upper jaw to a position beyond the construction bite, through a series of successively more forward positions relative to the maxilla. The orthopedic appliance 10 must usually be worn by the patient for approximately 6-18 months to achieve the result of a Class I occlusion. During this period, the upper teeth are moving posteriorly relative to the mandible and the mandible is moving forward. The present invention is designed to correct Class II malocclusions by changes in the muscular and structural growth of the temporal mandibular joint. For instance, during the initial three-month period after insertion of the orthopedic appliance, there is a rapid change about the mandibular condyle and muscle function. Due to the position of the frontal portion 12 of appliance 10 beyond the previously established position of the mandible, the skeletal and muscular growth changes can result in permanent movement anteriorly of the mandible relative to the maxilla. This anterior movement of the mandible even occurs with the expansion screw assemblies closed. After the treatment period is completed and appliance 10 is no longer used, the mandible generally moves posteriorly about one millimeter which generally results in full correction of the mandibular-maxilla relationship. The patient is instructed to wear the orthopedic appliance at all times during the treatment period except when eating, engaging in active sports and brushing the teeth. The appliance 10 is designed so that at all times of engagement the appliance is active, even when the patient moves his or her jaws, swallows or talks. The activation of the appliance 10 exerts a gentle pressure on the teeth and dental arches. This orthopedic appliance 10 is designed to fit intimately in the mouth and be capable of easy and frequent removal and replacement by the patient, much like a dental plate. This precise fit of the lower incisors forward into the appliance makes the patient to close his jaws together in the new relationship. This is a distinct advantage over the prior art. In light of the foregoing, it should be apparent that many variations are possible within the scope of the present invention. For example, the orthopedic appliance may be configured to include various orthodontic attachments such as labial wires and individual tooth moving springs so that the orthopedic appliance of the present invention performs orthodontic corrections at the same time as the Class II malocclusion is treated. The appliance may be adapted for use in Class II, division 2 as well as Class I malocclusions. Also, the treatment period will be generally be the same for every patient although many variations are necessary for each individual patient. Accordingly, the foregoing drawings, discussion and description are merely meant to be illustrative of particular embodiments of the invention and not limitations upon the practice thereof. It is the following claims including all equivalents which define the scope of the invention.

An orthopedic appliance for correcting Class II malocclusions comprises a frontal portion configured to engage the mandibular and maxillary frontal arches and first and second side portions, posterior to the frontal portion, each configured to engage at least some of the maxillary molars. A universal screw assembly interconnects the frontal portions and the first and second side portions and operate to independently adjust the lateral spacing of the side portions from one another and the anterior-posterior spacing of the frontal portion from the side portions. The appliance is expanded in stages to maximize the utilization of corrective lower jaw movements which result from securing the appliance in the patient's upper mouth.

BACKGROUND AND SUMMARY OF THE INVENTION This invention pertains to ventilating systems for buildings specifically adapted to house livestock. The system includes vents adapted to direct the airflow in a direction adapted to create a turbulence designed to avoid direct drafts on the livestock. In years past, most livestock was raised in open pastures, feed lots and the like. Livestock under those conditions were subjected to a full range of temperatures from the heat of summer to the bitter cold of winter in the northern parts of the United States. Frequently at those extremes of temperatures, the animals were subject to added stress because of the weather. Precipitation in the form of rain or snow added to that stress. The result was sometimes illness; or at the very least, a reduction in the efficiency of the conversion of feed into meat. More recently meat-type animals have been raised in enclosesd buildings. Especially female animals during late gestation and just after birth of their young have been confined in pens in fully enclosed buildings. Both the female and the young are susceptible to disease at these times, and are best protected from either cold or hot drafts within the building. By my invention, I provide a ventilating system that avoids direct draft onto the animals in the building, at the same time providing fresh air and avoiding chilling or overheating the livestock. Besides avoiding draft, my invention provides fresh and cool air to the area of the building at which the manure handling equipment is normally located. It is accepted that animals tend to go to cooler air to drop manure, and thus by my system, I provide for more convenience in manure handling because the animals will tend to congregrate near the fresh air. It might also be noted that in my new system, all of the air in the buildings is drawn to certain exhaust fans and that by the introduction of fresh air in a turbulent condition in which the air is not allowed to become stale, I provide an improved ventilation system. My system also provides much better clearing up of carbon monoxide, ammonia gas and moisture. Previous systems accomplished this only by drawing large amounts of air through the building. These amounts were acceptable when the air was reasonably warm. However in winter climates in northern states, the amount of air required to eliminate staleness was excessive so that it became too cold. By causing the turbulence, I pick up the carbon monoxide, ammonia gas, etc. without the need for pulling in the excess air that was required by former systems. FIGURES FIG. 1 is a detailed sectional view of the duct and ventilator of my system as it would normally be used, FIG. 2 is a diagrammatic view of a center installation of my system which may be desired in certain applications, FIG. 3 is a top plan view of the ventilator used in my system, FIG. 4 is an elevational view of a part of the ventilator and FIG. 5 is a sectional view from line 5--5 of FIG. 4. DESCRIPTION Briefly my invention comprises a ventilating system especially useful in buildings designed for the raising of livestock. The system avoids the problem of the direct draft of cold outside air onto the livestock in the building. More specifically and referring to the drawings, my system is designed for multiple use. The particular design for buildings where the livestock is principally penned in the center of the buliding and having walkways down the outside, is shown in FIG. 1. In this type building manure handling systems normally are placed along the outer walls. Where the aisle for the livestock handlers is down the center, usually in buildings greater than 32 feet wide, I use the system shown in FIG. 2. In such buildings, manure handling systems are usually placed along the center aisles so that fresh cool air should be available there. The systems are essentially similar except for the process of creating turbulence in the in-coming air. Referring to FIG. 1, I provide a duct system 10 having an outside opening 11 under the eaves 12 of the building adjacent its outer wall 13. I prefer to form the duct simply, by placing a board or similar barrier forming a cap 14 above the ceiling joints 15 so that the duct is simply the space between the joists 15, above the ceiling 16 and below the cap 14. Near the eave, it may be desirable, to provide walls 17 attached to the roof rafters 18 and extending to a soffit board 19 to enclose the duct more completely. For best results, these ducts are not isolated but extend along the full length of the side of the building. The duct between the joists in the embodiment of FIG. 1 should be relatively short. A barrier board 20 should define the end of the duct and direct any incoming airflow through a deflector 22. Preferably, this barrier is formed as a part of the deflector. That deflector may be built as a separate piece as shown in FIGS. 4-6. The deflector, as shown in FIGS. 4-6, includes an intake portion 35 extending normally upward and terminating in a flange 26 extending around the entire deflector. In some installations (best shown in FIG. 2 and described later) the deflector is open at the top 27. In the type of installation shown in FIG. 1, one wall of the upper section or intake portion 25 may be formed with an opening 28. In FIG. 1, this opening is open to the duct so that fresh air coming from the opening 11 will be conducted into the deflector. The intake section in either installation extends through the ceiling 16 and between the joists 15 and is fastened to the ceiling by fasteners such as nails extending through the flange 26. Below the flange 26, the deflector includes an air directing portion 31. This director 31 includes principally a scoop-shaped extension adapted to change the direction of flow of the air approximately 90 degrees from a vertical to a nearly horizontal direction. In the system of FIG. 1, this air director 31 is placed to direct the air towards the outer wall 13. Because the deflector is placed close to the wall, the air stream thus directed as it impinges on the wall creates a turbulence which breaks up the draft so that there will not be a draft directed at the animals in the building, but at the same time providing relatively cool air in the region of the manure handling system. The air directing portion 31 of the deflector may preferably be lined with a layer of insulating material 32. This allows cold air to be drawn through the deflector without chilling the exterior of the directing part. If that surface is chilled, condensation frequently forms and then drips into the building. Such dripping is undesirable, especially if it falls onto the livestock in the building. A door 33 pivotted at the top is used to close the outlet of the air directing portion of the deflector. This door in the closed position is held slightly off the vertical to be certain of closure. Not more than ten degrees deviation from the vertical is necessary, and no particular angle is required so long as closure is accomplished when ventilation is not required. In warmer temperatures, the exhaust fans which commonly draw the air from the buildings are run at higher speeds, thus drawing more air into the building. This increased flow will cause the door 33 to open somewhat wider and the air to leave the deflector in a more nearly horizontal flow. Thus, as the draft becomes stronger, the turbulence also becomes greater, with the result that direct draft is avoided as desired. In the alternate system illustrated in FIG. 2, the upper part 25 of the deflector is left open at the top 27 and it does not have an opening 28 formed in it. No ducting from the eaves is required here, but air is admitted to the attic of the building through one or more cupolas 32. It will be evident that the system of getting air to the deflector are substantially interchangeable, although I prefer to use the ducted air where the deflectors are directed against an outer wall. The deflectors are arranged in pairs in the system of FIG. 2 with the air from one of the pairs being directed toward the air coming from the other. Thus, the air streams impinge on each other creating the desired turbulence to avoid the undesired draft. In both systems, air is blown out of the building by the usual ventilating fans (not shown) which discharge through vents 35 on the outer wall of the building. This action by exhausting stale air from the building serves to draw fresh air into the building either through the ducts of the system of FIG. 1 or through the cupolas 32 of FIG. 2.

A ventilating system for a livestock confinement barn in which the outside air is directed against a wall or against other streams of air to destroy direct drafts of air which might chill the enclosed livestock. NAME: Allen W. Meendering TITLE: Livestock Building Ventilator

CROSS REFERENCE TO RELATED APPLICATION [0001] This application claims priority to U.S. Provisional application 60/622,848 filed Oct. 29, 2004. BACKGROUND OF INVENTION [0002] 1. Field of the Invention [0003] The inventive subject matter relates to an apparatus and method for the collection of dental wastewater during dental procedures without interrupting the dental vacuum system. [0004] 2. Description of Related Art [0005] Hg is generally found in three forms: elemental, inorganic and organic. Each form possesses its own characteristic toxicokinetics and human health effects. Elemental Hg volatilizes at room temperature and human exposure is primarily through inhalation of the vapor. Hg vapor is lipid soluble and easily crosses alveolar membranes of the lungs. Consequently, the Hg is taken up by red blood cells and transported to the central nervous system (Stone, et al, 2003). [0006] Inorganic Hg (also known as ionic Hg) is absorbed by the gastrointestinal tract in humans in only limited amounts. Only approximately 7% of ingested inorganic Hg is absorbed (Stone, et al, 2003) with kidney tissue accumulating the highest concentration. However, elemental Hg in human saliva can be oxidized to ionic Hg, which may be protective since ionic Hg is less toxic (Liang and Brooks, 1995 ). [0007] Organic Hg is the most environmentally important form of Hg. Organic Hg produces neurotoxic effects in adults. Additionally, the toxic effects on fetuses and young children is particularly acute due to the toxic effects on the developing nervous systems (Stone et al, 2003; Vogel, et al, 1985). Absorption of organic Hg can be as high as 95% with a marked affinity for the central nervous system (Vogel, et al, 1985; Steuerwal, et al, 2000). [0008] The environmental impact of mercury (Hg) release from dental operations is frequently dismissed due to the assumption that Hg in dental amalgam is unavailable for uptake by biologic organisms. The environmental significance of dental Hg was predicated on the assumption that dental Hg in dental amalgam is unavailable for uptake by biological organisms (Berthold, 2001). Recently, however, this notion has been dispelled (Arenholt-Bindslev, 1992; Stone, et al, 1999; Fan, et al, 1997). [0009] Previous dental collection systems are designed to remove particulate waste (amalgam separators), or both particulate and dissolved waste, from the dental wastewater slurry using a combination of gravity sedimentation, filtration, chemical oxidation, and ion-exchange materials (U.S. Pat. No. 3,138,873 to Bishop; U.S. Pat. No. 3,777,403 to Ritchie; U.S. Pat. No. 5,885,076 to Ralls, et al; U.S. Pat. No. 4,385,891 to Ligotti; U.S. Pat. No. 5,205,743 to Ludvigsson, et al; and U.S. Pat. No. 5,795,159 to Ralls, et al). [0010] The apparatus disclosed by U.S. patents to Ludvigsson, et al (U.S. Patent No. 5,205,743) and to Ralls, et al (U.S. Pat. No. 5,885,076) are relatively complex systems where waste material is passed through a series of filters. The apparatus disclosed by the U.S. patent to Bishop (U.S. Pat. No. 3,138,873) describes a system wherein slurry is passed through a porous bag that traps and collects particulate matter. The apparatus disclosed in U.S. Pat. No. 3,777,403 (to Richie) utilizes a system wherein liquid slurry is drawn by vacuum through a collection container and out the vacuum riser and into the drainage system. In U.S. Pat. No. 4,385,891 (to Ligotti), particulate matter settling to the bottom of a canister is enhanced by multiple aperatures in a baffle, separating the canister into two sections. Liquid is drawn out of the canister but particulate matter is allowed to settle and which is ultimately collected. The latter (i.e. U.S. Pat. No. 5,795,159 to Ralls, et al) is also designed to provide remove particulate matter and trapped in a seal-able container while liquid is passed through the system. [0011] The systems previously disclosed either require filtering or pass liquid slurry through the apparatus for disposal via the normal drainage system or other collection methods. Furthermore, the more complex systems operate with various efficiencies and complexity depending on particulate size distribution and flow rate. The most effective mercury removal systems are typically centrally located collection systems such as found in U.S. Pat. No. 5,885,076 to Ralls, et al and U.S. Pat. No. 6,521,131 to Hamilton, et al. [0012] Centrally located systems, while often effective at removing total mercury from dental wastewater suffer a number of disadvantages, even under optimum conditions. These include: 1) location of the apparatus at a distance from the source (i.e. the dental chair),which allows amalgam and mercury to settle and accumulate in dental office plumbing lines, eventually rendering these lines a hazardous waste material in themselves; 2) requirement to accurately size the system relative to the number of dental chairs serviced, total wastewater accumulation and amount of amalgam waste produced per unit of time; 3) complexity of installation; 4) accumulation over time of amalgam waste sludge in settling tanks in addition to the collection within the filters; 5) and complexity of chemical interactions that can occur over time, especially within holding tanks, between various materials, disinfectants, and chemicals used in the practice of dentistry (and contained within the wastewater slurry), and bacteria and waste materials that accumulate in settling tanks in constant contact with the wastewater slurry containing same (these interactions can produce compounds resistant to removal by the apparatus or even serve as an environment that fosters bacterial conversion of inorganic elemental mercury to organic methyl mercury). [0018] Therefore, large centrally located systems necessitate dental clinics from discharging hazardous waste into sewer systems or require the dental office to install expensive dental amalgam separators. A need, therefore, exists for collection systems that generate small volumes of wastewater for easier and less expensive waste management and sample collection. This can be achieved via a chairside collection system that is capable of separating of dental amalgam as particulate matter for easy transport to an off-site facility for storage or to remove harmful pollutants. Additionally, such a system can be utilized for collection of dental wastewater for clinical or laboratory sample analysis. SUMMARY OF THE INVENTION [0019] The inventive subject matter relates to a self-contained mercury filtration system that can effectively remove mercury particulate and finely dispersed particles from dental wastewater suction lines and permit collection of the wastewater and particulate matter. [0020] The inventive subject matter also relates to a self-contained waste collection system for chairside use that is contained within or attached to a dental chair or dental unit in line with the existing high vacuum evacuation (HVE) suction line. [0021] The inventive subject matter further relates to a self-contained a dental chair wastewater collection system that generates low volumes of dental wastewater. [0022] The inventive subject matter additionally relates to a self-contained mercury filtration container that can be safely removed and replaced at regular intervals for transport to off-site treatment and management of hazardous materials. BRIEF DESCRIPTION OF THE DRAWINGS [0023] FIG. 1 is a drawing of the collection container showing the operational relationship to patient, inlet line and vaccum. [0024] FIG. 2 is a cross-sectional view of the inlet apparatus connected to the collection container. [0025] FIG. 3 is a cross-sectional view of the inlet apparatus. DESCRIPTION OF PREFERRED EMBODIMENTS [0026] The invention contemplates a simple dental wastewater collection system intended for placement in-line with an existing High Vacuum Evacuation (HVE) suction line in dental units that is capable of collecting wastewater and dental waste particulate matter. The inventive apparatus is capable of collecting dental waste, chair side, without waste flowing from the apparatus into the vacuum line and drainage system. [0027] An example of the inventive apparatus is illustrated in FIGS. 1, 2 and 3 . The apparatus contains a container ( 1 ) capable of holding dental evacuation wastewater and dental-waste particulate matter. The container is of suitable size for holding an adequate volume of waste from a dental patient or multiple dental patients. A preferred size is 1-2 liters in size. However, any size container be used. The container is constructed of any number of materials, including metal, glass or plastic. The container, containing an inside portion, and outside portion and an upper and bottom portion and lid ( 3 ) connected to upper portion. The container ( 1 ) contains a gasket ( 21 ) around the inside of the lid in order to permit a tight seal and maintenance of pressure until released. The container also contains a pressure release value ( 23 ) to permit easy disconnect from the vacuum tube ( 19 ) to permit transport and emptying of contents or the re-attachment of a replacement container. [0028] Connected and protruding through the lid ( 3 ) and into the container ( 1 ) is an inlet apparatus ( 5 ). The inlet apparatus contains an inside ( 7 ) and outside portion ( 9 ). The inside portion ( 7 ) of the inlet apparatus ( 5 ) is disposed lengthwise through the inlet apparatus and is operationally connected to an inlet line ( 11 ) from the patient. The outside portion ( 9 ) of the inlet apparatus forms a space ( 13 ) between the inside portion ( 7 ) and the outside portion ( 9 ). The space ( 13 ) protrudes into the container ( 1 ) such that the inlet apparatus space ( 13 ) contains an opening ( 15 ) exposed to the inside of the container ( 1 ). The space ( 13 ) is also operationally connected to a vacuum line operationally connected to a vacuum source ( 17 ) via a vacuum tube ( 19 ). The inside portion ( 7 ) also protrudes into the container ( 1 ) such that wastewater and dental-waste particulate matter is permitted to pass from the patient and into the container ( 1 ). The distance of said protrusion of the inside portion ( 7 ) of the inlet apparatus ( 5 ) into the container must be sufficiently far such that matter flowing out of the inlet portion ( 7 ) is not sucked into the opening ( 15 ) of said inlet apparatus space ( 13 ) and ultimately into the vacuum tube ( 19 ). The distance of the protrusion of the inlet portion ( 7 ) into the container is dependent on the distance that the inlet apparatus space ( 13 ) protrudes into the container ( 1 ) and the strength of the vacuum supplied to the container ( 1 ) via the vacuum tube ( 19 ). The inlet apparatus can be made of any material including glass, metal or plastic. [0029] The representation of each element is diagrammatic. The figures illustrate relative relationships of each of the elements to one another and are general rather than actual. The figures are not representative of precise ratios of dimensions. However, while size (height and circumference) is to some extent variable with respect to desired volume, placement on or next to the dental chair or even dental unit, the total volume of air capacity within the invention must be sufficient suction and flow rate to permit movement of material through the tubes. Placement of the device is primarily intended to be next to the dental chair. However, the device can be placed anywhere as long as sufficient suction is provided by the HVE. [0030] Removal and collection of dental wastewater and particulate matter can be achieved by drawing dental waste, as a liquid slurry, from the patient into the above described apparatus. Particulate matter and liquid is deposited, by gravity, into the container ( 1 ) of FIG. 1 and 2 . Vacuum to the container is maintained by a vacuum line supplied to the opening to the container in the inlet apparatus ( 15 ) by the vacuum pump ( 17 ) via the vacuum tube ( 19 ). The contents of a nearly full container ( 1 ) is either emptied into another container for storage or transport to a treatment facility or the container ( 1 ) replaced with a new container. Detachment of the full container is accomplished by first releasing the vacuum via the pressure release value ( 23 ) and removing the lid ( 3 ). [0031] Liquid and/or particulate matter samples, such as dental amalgam or mercury, can be collected from the container following dental procedures. Samples, containing both particulate matter and liquid can be collected directly as described above. However, samples containing only particulate matter or liquid without large particulate matter can also be collected by first allowing the particulate matter, such as dental amalgam, to settle to the bottom of the container ( 1 ). After the particulate matter has settled to the bottom, the liquid wastewater is either poured or aspirated off the underlying particulate matter. The liquid can then be collected and stored for clinical use or, alternatively, deposited in another container for disposal as dental-waste. Similarly, the particulate matter can be collected, free of liquid wastewater for further use or disposed of as necessary. [0032] The above example is given to illustrate specific applications of the invention including the best mode now known to perform the invention. The example is not intended to limit the scope of the invention described in this application. REFERENCES [0033] 1. Arenholt-Bindslev, D., (1992) Dental amalgam-environmental aspects. Adv. Dent Res. 6: 125-30. [0034] 2. Berthold M., (2001) Proven track record: Science shows dental amalgam is safe, effective. ADA News 32 (13):13. Comment by Rodway J. Mackert, Jr. DMD, Ph.D. [0035] 3. Bishop, Harold P. 1964. Vacuum attachment for dental aspirator unit. U.S. Pat. No. 3,138,873 issued Jun. 30, 1964. [0036] 4. Fan, P. L., D. Arenbolt-Bindslev, G. Schmalz, S. Halback, H. Berendsen, (1997) Environmental issues in dentistry-mercury. Int. Dent. J. 47: 105-9. [0037] 5. Hamilton, Richard A., Scott P. Fulton, Ted M. Shields. 2003. Combined oxidation and chelating adsorption system for removal of mercury from water. U.S. Pat. No. 6,521,131 Feb. 18, 2003. [0038] 6. Liang, L., R. J. Brooks, (1995) Mercury reactions in the human mounth with dental amalgams. Water Air and Soil Pollut, 80: 103-7. [0039] 7. Ligotti, Eugene, F. 1983. Dental apparatus for preventing loss of precious metal particles. U.S. Pat. No. 4,385,891 issued May 31, 1983. [0040] 8. Ludvigsson, Bjorn M., D. L. Stromberg. 1993. Dental treatment method. U.S. Pat. No. 5,205,743 issued Apr. 27, 1993. [0041] 9. Ralls, Stephen Alden, William Corry Roddy. 1998. Mercury removal method and apparatus. U.S. Pat. No. 5,795,159 issued Aug. 18, 1998. [0042] 10. Ralls, Stephen Alden, William Corry Roddy, Ernest David Pederson. 1999. Method and system for removing mercury from dental waste water. U.S. Pat. No. 5,885,076 issued Mar. 23, 1999. [0043] 11. Ritchie, John, K. 1973. Dental silver retrieval apparatus. U.S. Pat. No. 3,777,403 issued Dec. 11, 1973. [0044] 12. Steuerwal, U., P. Weihe, P. J. Jorgensen, K. Bjerve, J. Brock, B. Heinzow, E. Budtz-Jorgensen, P. Grandjean, (2000) Maternal seafood diet, methyl mercury exposure, and neonatal neurologic function. J. Pediatr. 136(5): 599-605. [0045] 13. Stone, M. E., M. E. Cohen, L. Liang, P. Pang, (2003) Determination of methyl mercury in dental-unit wastewater. Dental Materials 19: 675-679. [0046] 14. Stone, M. E., E. D. Pederson, G. K. Jones, J. C. Ragain, R. S. Karaway, R. A. Auxer, S. L. Davis, (1999) Mercury removal from the dental-unit wastewater stream. Proceedings of specialty conference: mercury in the environment. Air and waste management association in conjunction with the EPA, Sep. 15-17, Minn. Minnesota, VIP-91: 413-24. [0047] 15. Vogel, D. G., R. L. Margolis, N. K. Mottet, (1985) The effects of methyl mercury binding to microtubules. Toxicol Appl Pharmacol., 80: 473-86.

The invention relates to a dental chair side wastewater collection system for dental-unit wastewater for sample analysis or collection and management of dental-unit wastewater hazardous materials. The system is small enough to be installed chair side to permit collection of an entire days wastewater or wastewater from a single patient for immediate disposal or for sample collection. Collected wastewater can then be easily emptied and stored elsewhere until disposed.

TECHNICAL FIELD The present invention relates generally to an apparatus and method of processing logs, and, more specifically, to an apparatus and method which provides for delimbing, cut-to-length, and log handling functions in a single assembly. BACKGROUND In the forestry industry, it is common practice for a logging operator to cut down trees by hand or using a harvester-type machine, transport the logs (logs is used herein to refer to felled trees) to a central processing/loading location using a forwarder or the like, delimb the logs with a delimbing machine or by hand, optionally cut the logs to length by hand or using a work machine, and load the whole or cut logs onto a truck or other transport using a log loader. As is intuitively obvious, this sort of operation requires a great number of different work machines which must be purchased and maintained, necessitating a wide range of replacement parts be available. The machines also are frequently idle when the supply feed of logs is uneven, and a breakdown of one machine can cause the entire operation to stop entirely. All of the above may cause the logging operator to incur great expense and loss of productivity. It is thus common in the art for work machines to perform more than one of the aforementioned functions, in an attempt to reduce the number of machines and operators needed for a successful logging operation. However, many of these combination machines are mechanically quite complicated and perform multiple jobs poorly in comparison to single-function machines, which has resulted in a tendency for logging operators to continue to use the single-function machines. Such a combination machine is disclosed in U.S. Pat. No. 5,628,354, issued May 13, 1997 to Aloysius Kingston (hereafter referenced as '354). '354 relates to a tree delimbing and severing attachment, which is optionally mounted on the trailer of a forwarder. The '354 machine may be used to process felled trees at the felling location and to carry logs therefrom to a forest road and then the central processing/loading location. '354, however, may have the disadvantages of scattering the discard material about the logging site, requiring multiple grapple cycles to transfer the cut-to-length logs to the forwarder trailer, and requiring a highly skilled operator to maneuver and delimb the logs in the often tight confines of a felling location, among others. Accordingly, the art has sought a method and apparatus of processing logs which: successfully and efficiently combines several logging work functions in one apparatus; allows for logs to be processed in a central location which may be chosen to eliminate spacial constraints; performs several operations without requiring multiple instances of handling/moving the same log; may be used in a timely and efficient manner; and is more economical to manufacture and use. The present invention is directed to overcoming one or more of the problems as set forth above. SUMMARY OF THE INVENTION In an embodiment of the present invention, an apparatus for processing logs is provided. The apparatus includes a linkage having a boom and a stick. The boom is adapted for attachment to a support platform. A delimbing assembly is connected to the boom, and a loading assembly is connected to the stick. In an embodiment of the present invention, a method of processing logs using a log processing apparatus is provided. The method includes the steps of picking up a log, delimbing the log, and placing the log into a desired position. In an embodiment of the present invention, a work machine for processing and loading logs is provided. The work machine includes a body, an engine, propulsion means, an operator compartment, a linkage connected to the body, and a log processing assembly connected to at least one of the linkage and the body. The log processing assembly includes a delimbing portion and a loading portion. In an embodiment of the present invention, a method of processing logs is provided. The method includes the steps of picking up a log with a loading assembly of a work machine and delimbing the log with a delimber of the work machine. The method also includes the steps of determining at least one of a total length value, a partial length value, and a girth value of the log with a measuring system of the work machine and determining a desired length or lengths of the log using at least one of the total length value, partial length value, and girth value of the log. The method also includes the steps of cutting the log to the desired length or lengths with one or more saws of the work machine and placing the length or lengths of the log in a predetermined position with the loading assembly of the work machine. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side view of the apparatus of a preferred embodiment of the present invention; and FIG. 2 is a side view of the apparatus mounted on a work machine of a preferred embodiment of the present invention. DETAILED DESCRIPTION A preferred embodiment of the present invention provides an apparatus and method of processing logs. The following description uses an excavator as an example only. This invention may be applied to other types of work machines. Referring to FIG. 1, a log processing apparatus 100 is provided. The apparatus 100 has a linkage 102 . The linkage 102 includes a boom 104 and a stick 106 . The boom 104 is attachable to a support platform (not shown). The stick 106 is connected to the boom 104 for relative movement thereto. The apparatus 100 also includes a delimbing assembly 108 and a loading assembly 110 . The delimbing assembly 108 and the loading assembly 110 are each attached to one of the boom 104 and stick 106 . Preferably, the delimbing assembly 108 is attached to the boom 104 , and the loading assembly 110 is attached to the stick 106 . The delimbing assembly 108 preferably includes a log delimbing support system 112 , delimbing knives 114 , and a butt saw assembly 116 . The log delimbing support system 112 acts to provide support for the log as it is being delimbed. The term “delimbing” is meant to refer to any combination of delimbing and debarking operations herein. A preferred embodiment of the delimbing support system 112 is shown in FIG. 1 . This embodiment includes a support trough 118 , a hold-down roller 120 , and a drive mechanism 122 . The loading assembly 110 preferably includes a grapple 124 , a topping saw assembly 126 , and a log loading support system 128 . The log loading support system 128 acts to provide leverage and support for the log as it is being loaded and may act to steady the log. A preferred embodiment of the log loading support system 128 is shown in FIG. 1 . This embodiment includes a commonly used heel assembly 130 . Optionally, the apparatus 100 also includes a log measurement system (not shown). The log measurement system has at least one measurement sensor 132 and produces at least one log measurement signal. This signal indicates one or more of a longitudinal characteristic (“length”) or a diametrical characteristic (“girth” or “diameter”), of all or a portion of the log. In a preferred embodiment of the present invention, shown in FIG. 1, the linkage 102 includes one or more linkage joints 132 ′ at the connections between the various components of the linkage 102 , and each linkage sensor 132 ′ includes a measurement sensor 132 . The measurement sensors 132 can measure the relative angles of the components of the linkage 102 , and, knowing the length of the components, the log measurement system can determine a position in space of the grapple 124 , the topping saw assembly 126 , the butt saw assembly 116 , or any other portion of the apparatus 100 . Once the relative position of the components of the apparatus 100 is known, one skilled in the art can determine the length of the log or a portion thereof being processed by the apparatus 100 , and thereby accurately cut the log to a desired length or lengths. The butt saw assembly 116 and the topping saw assembly 126 can be bar saws, disk saws, shears, chainsaws, flails, or any other known means to sever or cut the log in a desirable manner. Each of the butt saw assembly 116 and the topping saw assembly 126 can be mounted at any convenient location on the apparatus 100 . The presence of either or both of a butt saw assembly 116 and a topping saw assembly 126 is not required for proper function of the apparatus 100 . Referring now to FIG. 2, the apparatus 100 is shown mounted on a work machine 200 . The work machine 200 shown in FIG. 2 is commonly known as an excavator or hydraulic excavator. The work machine 200 includes a body 202 , an engine 204 , propulsion means 206 , an operator compartment 208 , and the apparatus 100 . In FIG. 2, the work machine 200 acts as a support platform for the apparatus 100 , but various other embodiments of a support platform can be envisioned, such as, but not limited to, a stanchion, pier, platform, trailer, footing, and the like. While aspects of the present invention have been particularly shown and described with reference to the preferred embodiment above, it will be understood by those skilled in the art that various additional embodiments may be contemplated without departing from the spirit and scope of the present invention. For example, the log could have been previously at least partially delimbed, the log measurements could be obtained differently, or the linkage could have more sections in addition to the boom and stick. However, a device or method incorporating such an embodiment should be understood to fall within the scope of the present invention as determined based upon the claims below and any equivalents thereof. INDUSTRIAL APPLICABILITY In the following description, the apparatus 100 of the present invention will be assumed to be mounted upon a work machine 200 and located at a central processing/loading location. The apparatus 100 will be referred to as a “processor” 100 . These terms are used for convenience of reference and should not be construed to limit the scope of the invention in any way. The following describes the operation of a preferred embodiment of the present invention. During a logging operation at a forest location, trees are cut by a harvester and the resulting logs are transported to the central processing/loading location by a forwarder. The logs, still carrying-bark and limbs, are unloaded from the forwarder. The processor 100 then picks up each log with its grapple 124 and feeds it into the delimbing assembly 108 in a known manner. The delimbing knives 114 remove the limbs and/or bark from the log as the log is passed between them, either on the intake or output pass of the log. When the log is sufficiently seated in the delimbing assembly 108 , either the grapple 124 or a combination of the hold-down roller 120 and a drive mechanism 122 provides motive power to draw the log (intake pass) between the delimbing knives 114 in a direction away from the loading assembly 110 while a support trough 118 serves to support the weight of the length of the log. A motive power is then applied to move the log in a direction toward the loading assembly 110 (output pass). Optionally, a topping saw assembly 126 and/or butt saw assembly 116 may be employed in a known manner, manually or automatically, to remove one or more ends of the log as the tree is being delimbed or loaded. In the case of a whole-tree operation, once the log is delimbed, it is removed from the delimbing assembly 108 on its output pass by the loading assembly 110 and placed/loaded in a predetermined location by the operator, using the loading assembly 110 . If the log is being processed for a cut-to-length operation, a measurement system may be employed to measure the log's length, partial length, girth, or any other property to determine when a desired portion of the log has passed from the delimbing assembly 108 on the output pass. The delimbed log is removed from the delimbing assembly 108 as above, until a desired length of the log has been removed from the delimbing assembly 108 . The topping saw assembly 126 and/or butt saw assembly 116 may then be employed to cut the log at that position, thus producing a child log from the parent log. The child log is then placed into a predetermined location as above and the parent log continues its output pass. This operation may be repeated as needed to produce a desired number of child logs. The measurement system also may be used to monitor log production, waste generation, or any other properties which may be determined from the log's length, partial length, and girth. The apparatus and method of certain embodiments of the present invention, when compared with other methods and apparatus, may have the advantages of: successfully and efficiently combining several logging work functions in one apparatus; allowing for logs to be processed in a central location which may be chosen to eliminate spacial constraints; performing several operations without requiring multiple instances of handling/moving the same log; being used in a timely and efficient manner; and being more economical to manufacture and use. Such advantages are particularly worthy of incorporating into the design, manufacture, and operation of forestry machines. In addition, the present invention may provide other advantages that have not yet been discovered. It should be understood that while a preferred embodiment is described in connection with an excavator, the present invention is readily adaptable to provide similar functions for other work machines. Other aspects, objects, and advantages of the present invention can be obtained from a study of the drawings, the disclosure, and the appended claims.

The present invention provides an apparatus and method of processing logs. The apparatus includes a linkage having a boom and a stick. The boom is adapted for attachment to a support platform. A delimbing assembly is connected to the boom, and a loading assembly is connected to the stick. The method includes the steps of picking up a log, delimbing the log, and placing the log into a desired position.

BACKGROUND OF THE INVENTION It is desirable to provide lousicidal compositions. An ideal lousicidal composition should meet at least the following requirements, namely: (i) the composition should be convenient and easy to use; (ii) the composition should be capable of "one-shot" use, that is one application of the composition should be capable of dealing with a case of louse infestation; (iii) the composition should be stable and have an acceptable shelf-life. SUMMARY OF THE INVENTION The invention relates to improvements in lousicidal compositions, particularly to compositions for topical application to the scalp and hair for the purpose of killing arthropod parasites such as lice and/or their ova (ova). The invention is particularly directed to shampoo compositions which contain phenothrin as lousicidal agent. It is accordingly a primary object of the present invention to provide a shampoo composition which contains phenothrin as lousicidal agent and which provides all of the above desired properties for such lousicidal shampoo composition. It is another object of the present invention to provide a phenothrin shampoo which can be easily and readily applied to the hair and scalp and which is susceptible of one shot application for the treatment of lice. Other objects and advantages of the present invention will be apparent from a further reading of the specification and of the appended claims. With the above and other objects in view, the present invention comprises a lousicidal composition which is a shampoo containing phenothrin as lousicidal agent, together with a shampoo base of water and at least one surface active agent, the shampoo composition containing as antimicrobial preservative 2-bromo-2-nitropropane-1,3-diol, either alone or in combination with 2,4-dichlorobenzyl alcohol. The present invention further provides a method for controlling lice or their ova which comprises topical application of a lousicidal shampoo comprising a lousicidally effective amount of phenothrin and an antimicrobial preservative which is either 2-bromo-2-nitropropane-1-3-diol alone or in combination with 2,4-dichlorobenzyl alcohol, the phenothrin and the antimicrobial agent being distributed in a shampoo base of water and at least one surface active agent. The amount of phenothrin in the shampoo composition of the present invention should be sufficient to control lice or their ova and the amount which is suitable for the purposes of the present invention is between about 0.05-10% by weight of the shampoo, preferably 0.1-10% by weight and most preferably about 0.2% by weight. As indicated, the shampoo base comprises water and at least one surface active agent or surfactant, preferably a mixture of surfactants. The water suitably forms about 5-90% by weight of the base, preferably about 20-60% by weight and most preferably about 40% by weight, the balance of the shampoo base comprising mainly the surfactant component. In addition, there may be smaller amounts, up to about 20% by weight of the total, of ingredients such as preservatives, pH adjusters, buffering agents, dyes, foam boosters, viscosity adjusting agents, foam stabilizers, antioxidants, chelating agents, conditioning agents, coloring agents, perfumes, etc. The surface active components typically comprise one or more pharmaceutically acceptable anionic surface active agents, particularly alkali metal alkyl ether sulfates such as sodium lauryl ether sulfate, generally forming about 10% by weight of the surface active component, together with one or more non-ionic surface active agent such as polyethyleneglycol, polyethoxylated alkyl phenols, polyethoxylated alcohols and long chain fatty acid mono- and di-alkanolamides. In accordance with the preferred embodiments of the invention, the non-ionic surface active component is such as to dissolve the phenothrin in the base, and is present in the shampoo base in a sufficient quantity to achieve such dissolution, thus increasing its effectiveness. To this end, the shampoo in accordance with the invention suitably contains relatively large amounts of non-ionic surfactants, e.g. 10-50% by weight based on the total weight of the shampoo. As noted above, the shampoo of the invention will also generally contain other ingredients in minor amounts, for example pH adjusters, buffering agents, coloring agents, and perfumes, provided of course that they are pharmaceutically acceptable, compatible with the lousicide and soluble in water. The nature and amounts of such other ingredients are such as are commonly used in shampoos or so-called "medicated" shampoos. We have found that, in order to meet the specification prescribed in the British Pharmacopoeia 1988 "Efficacy of Antimicrobial Preservatives in Pharmaceutical Products", many conventional preservatives in conventional amounts do not afford adequate antimicrobial protection. We have found, however, that the preservative (trade name "bronopol"), 2-bromo-2-nitropropane-1,3,-diol, especially when used in conjunction with the preservative 2,4-dichlorobenzyl alcohol (trade name "Myacide"), affords good antimicrobial protection. Surprisingly, there appears to be interdependence between the preservative component and the phenothrin, since the same shampoo composition, in which phenothrin is replaced by another lousicide, carbaryl, does not show adequate antimicrobial properties. When bronopol is used as preservative alone it is suitably present in the shampoo in an amount of 0.05 to 0.2% by weight; when a combination of bronopol and Myacide SP are employed together as preservatives they are suitably used in amounts of 0.01 to 0.2 and 0.5 to 0.5% by weight, respectively. When bronopol is present as preservative, the composition according to the invention desirably contains an antioxidant such as butylated hydroxytoluene, butylated hydroxyanisole or ascorbic acid to prevent degradation of the preservative, with butylated hydroxytoluene being preferred. The composition accordingly to the present invention may be used to control lice or their ova by applying the composition to the site of infestation. Alternatively, the composition may be used prophylactically to prevent infestation. In a further aspect, the invention provides a process for preparing a lousicidal shampoo containing phenothrin as lousicide agent and bronopol either alone or in combination with Myacide as preservative, which comprises distributing a lousicidally effective amount of phenothrin, bronopol and optionally Myacide and one or more surface active agents in water. DESCRIPTION OF PREFERRED EMBODIMENTS The following examples are given to further illustrate the present invention. The scope of the invention is not, however, meant to be limited to the specific details thereof. EXAMPLE 1 A shampoo having the following formulation was prepared; ______________________________________ % w/w______________________________________Phenothrin 0.2Bronopol BP 0.1Myacide SP 0.1Butylated hydroxytoluene 0.05Sodium lauryl ether sulphate 70% 20.0Polyethylene glycol 400 USNF 4.0Coconut diethanolamide (Comperlan KD) 1.0Nonoxynol-9 USP 12.4Ethoxylated Lanolin 50% 3.0Buffering agents, dyes, perfumes as requiredPurified Water EP to 100______________________________________ Purified water equivalent to approximately 50% of the batch weight was placed in a mixer and heated to approximately 80° C. Coconut diethanolamide, sodium lauryl ether sulphate 70%, ethoxylated lanoline 50%, polyethylene glycol 400, nonoxynol-9 and butylated hydroxytoluene were added and mixed to obtain a uniform dispersion. The remaining minor ingredients were added as required and mixed. The solution was cooled to 60° C. and phenothrin and Myacide added with mixing. The solution was further cooled to 30° C. and a solution of bronopol in purified water added. Further purified water was added to achieve the final batch weight of 500 kg and the whole was again mixed until uniform. MICROBIOLOGICAL TEST The test procedure conformed with the specifications described in the 1988 British Pharmacopoeia--"Efficacy of Antimicrobial Preservatives in Pharmaceutical Products". 1. Inoculation of Product Aliquots of microbial suspensions of Pseudomonas aeruoinosa NC18 8626, Stahylococcus aureus NCTC 10788, Candida albicans NCPF 3179, and Asperoillus niger IMI 149007 were introduced into separate containers of the composition of Example 1 to achieve a final concentration of approximately 1×10 6 cfu/ml. The same volume of inoculum was simultaneously introduced into separate equivalent quantities of 0.1% peptone water to be used as controls. The inoculated product was stored in the dark at 20°-25° C. 2. Recovery of Microorganisms 1 ml aliquots of the inoculated product were removed at 0, 6, 24 and 48 hours, 7, 14 and 28 days. Each was added to 9 ml of 0.1% peptone water containing the following as preservative inactivating agents: ______________________________________Polysorbate 1.0%Lecithin 0.5%Cirrasol 1.0%Sodium thiosulphate 1.0%______________________________________ The control preparations were similarly sampled at 0 hours to determine the viable counts of the cultures used and to confirm the suitability of the media used for their growth. Further dilutions were made as necessary in 0.1% peptone water and 1 ml aliquots of all dilutions were incorporated in pour plates of the appropriate cooled molten agar containing 0.1% cysteine hydrochloride. The pour plates were incubated at 30° C. for three days for the bacteria and at 23° C. for five days for the yeasts and mould. After incubation the number of colonies on each plate were counted and, taking the dilution factor into account, the number of cfu/ml of product calculated. These figures are listed in the tables. 3. Validation of Recovery Counts The suspensions of the test organisms were further diluted with 0.1% peptone water to approximately 10 2 cfu/ml. Three petri dishes were used for each organism and 0.1 ml of the relevant suspension added to each plate. To the first set of plates 1 ml of product diluted 10 fold in recovery medium was added, to the second set 1 ml of product diluted 100 fold was added and the third set acted as a control having no product in them. The appropriate cooled molten agar was then added to the plates which were incubated as described above. The plates were then examined for growth and the number of colonies present recorded on the raw data sheet. ______________________________________RESULTSControl Count at 0 HourOrganism cfu/ml______________________________________C. albicans 140 × 10.sup.4A. niger 80 × 10.sup.4P. aeruginosa 120 × 10.sup.4S. aureus 68 × 10.sup.4B 141 60 × 10.sup.4______________________________________ VALIDATION OF RECOVERY COUNTS No inhibition was noted on any of the validation plates. Counts of <5 cfu/ml are therefore valid. RECOVERY COUNTS FOR EXAMPLE 1 Phenothrin Shampoo (0.1% Bronopol+0.1% Myacide). A topical preparation is considered to be effectively preserved if the following criteria are met: Bacteria--the number of organisms recovered per ml is reduced by a factor of not less than 10 3 within 48 hours of challenge and no organism is recovered from 1 ml at 7 days and thereafter; Moulds and Yeasts--the number of organisms recovered per ml is reduced by a factor of not less than 10 2 within 14 days of challenge and there is no increase thereafter. From the results below it can be seen that the shampoo of Example 1 meets these requirements. __________________________________________________________________________MEAN COUNTS/ML SAMPLE AFTER 0 hr 6 hr 24 hr 68 hr 7 days 14 days 28 days__________________________________________________________________________C. albicans 138 × 10.sup.4 74 × 10.sup.4 114 × 10.sup.3 90 <5 <5 <5A. niger 61 × 10.sup.4 68 × 10.sup.3 34 × 10.sup.3 140 × 10.sup.2 <5 <5 <5P. aeruginosa 106 × 10.sup.4 <5 <5 <5 <5 <5 <5S. aureus 72 × 10.sup.4 189 × 10.sup.2 <5 <5 <5 <5 <5__________________________________________________________________________ While the invention has been illustrated with respect to particular compositions, it is apparent that variations and modifications of the invention can be made.

The invention relates to a lousicidal shampoo composition of phenothrin as lousicidal agent distributed in a shampoo base of water and one or more surface active agents, the shampoo containing as antimicrobial preservative 2-bromo-2-nitropropane-1,3-diol alone or in combination with 2,4-dichlorobenzyl alcohol.