Biomatrix structural containment and fixation systems and methods of use thereof

Abstract

The containment and fixation system of the present invention generally includes a biomatrix sleeve, biomatrix particles or combinations thereof made of a biomatrix material. The biomatrix material is comprised of one or more biocompatible proteins and one or more biocompatible solvents. The biomatrix material utilized in the sleeve and/or particles may also include one or more pharmacologically active agents like therapeutic biochemicals such as a bone mending biochemical (e.g. hydroxyapatite) or an angiogenic growth factor (e.g. BMP).

1 . A biomatrix containment and fixation system comprising:
 a containment and fixation sleeve including one or more tubes having one or more biocompatible proteins combined with one or more biocompatible solvents, said sleeve formed to create an enclosure; and   a plurality of protein particles administered within the enclosure of said sleeve, said protein particles including one or more biocompatible proteins combined with one or more biocompatible solvents and one or more pharmacologically active agents.   
     
     
         2 . The biomatrix containment and fixation system of  claim 1  wherein the tube includes one or more sheets having two ends adhered together with one or more fastening devices. 
     
     
         3 . The biomatrix containment and fixation system of  claim 1  wherein the biocompatible proteins are selected from the group consisting of elastin, collagen, albumin, ovalbumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin, antithrombin III, elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike, elastinlike blocks, collagen-heparin, collagen-elastin-albumin-heparin, collagen-albumin collagen-elastin-heparin and collagen-chondroitin. 
     
     
         4 . The biomatrix containment and fixation system of  claim 1  wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols. 
     
     
         5 . The biomatrix containment and fixation system of  claim 1  wherein the one or more pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, angiogenic growth factors, bone mending biochemicals, steroids, antisteroids, corticosteroids, antiglacoma agents, antialcohol agents, anti-coagulants agents, genetic material, antithrombolytic agents, anticancer agents, anti-Parkinson agents, antiepileptic agents, anti-inflammatory agents, anticonception agents, enzymes agents, cells, growth factors, antiviral agents, antibacterial agents, antifungal agents, hypoglycemic agents, antihistamine agents, chemoattractants, neutraceuticals, antiobesity, smoking cessation agents, obstetric agents and antiasmatic agents. 
     
     
         6 . The biomatrix containment and fixation system of  claim 4  wherein the pharmacologically active agents are hydroxyapatite, bone morphogenic protein VEGF or combinations thereof. 
     
     
         7 . The biomatrix containment and fixation system of  claim 2  wherein the fastening devices are one or more devices selected from the group consisting of staples, cerclages, screws, plates, adhesives, bindings and sutures. 
     
     
         8 . The biomatrix containment and fixation system of  claim 1 , wherein the sleeve, particles or both further comprise one or more biocompatible additives. 
     
     
         9 . The biomatrix containment and fixation system of  claim 7  wherein the one or more biocompatible additives are selected from the group consisting of epoxies, polyesters, acrylics, nylons, silicones, polyanhydride, polyurethane, polycarbonate, poly(tetrafluoroethylene), polycaprolactone, polyethylene oxide, polyethylene glycol, poly(vinyl chloride), polylactic acid, polyglycolic acid, polypropylene oxide, poly(alkylene)glycol, polyoxyethylene, sebacic acid, polyvinyl alcohol, 2-hydroxyethyl methacrylate, polymethyl methacrylate, 1,3-bis(carboxyphenoxy)propane, lipids, phosphatidylcholine, triglycerides, polyhydroxybutyrate, polyhydroxyvalerate, poly(ethylene oxide), poly ortho esters, poly(amino acids), polycyanoacrylates, polyphophazenes, polysulfone, polyamine, poly(amido amines), fibrin, graphite, flexible fluoropolymer, isobutyl-based, isopropyl styrene, vinyl pyrrolidone, cellulose acetate dibutyrate, silicone rubber, and copolymers of these. 
     
     
         10 . The biomatrix containment and fixation system of  claim 1  wherein all or a portion of the sleeve and particles are crosslinked with one or more crosslinking agents. 
     
     
         11 . The biomatrix containment and fixation system of  claim 9  wherein the one or more crosslinking agents are selected from the group consisting of glutaraldehyde, p-Azidobenzolyl Hydazide, N-5-Azido 2-nitrobenzoyloxysuccinimide, N-Succinimidyl 6-[4′azido-2′nitro-phenylami-no]hexanoate and 4-[p-Azidosalicylamido]butylamine. 
     
     
         12 . The biomatrix containment and fixation system of  claim 1  wherein the particles have a size of approximately 10 nm to 5 mm. 
     
     
         13 . A method of treating a fracture with the biomatrix containment and fixation system of  claim 1 , the method comprising:
 positioning around a fracture the sleeve including one or more biocompatible materials, wherein the enclosure contains the fracture; and   positioning inside the enclosure of the sleeve the plurality of protein particles, said protein particles including the one or more biocompatible proteins combined with the one or more biocompatible solvents and the one or more pharmacologically active agents.   
     
     
         14 . The method of  claim 13  wherein the sleeve includes one or more sheets that form the sleeve by securing one end of a sheet to an opposite end of the sheet or another sheet with one or more fastening devices to form the enclosure. 
     
     
         15 . The method of  claim 14  wherein the fastening device is one or more devices selected from the group consisting of staples, cerclages, screws, plates, adhesives, bindings and sutures. 
     
     
         16 . The method of  claim 13  wherein the sleeve comprises one or more biocompatible proteins combined with one or more biocompatible solvents and optionally one or more pharmacologically active agents. 
     
     
         17 . The method of  claim 13  wherein the biocompatible proteins of the sleeve are selected from the group consisting of elastin, collagen, albumin, ovalbumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin, antithrombin III, elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike, elastinlike blocks, collagen-heparin, collagen-elastin-albumin-heparin, collagen-albumin collagen-elastin-heparin and collagen-chondroitin. 
     
     
         18 . The method of  claim 13  wherein the biocompatible solvent of the sleeve is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols. 
     
     
         19 . The method of  claim 13  wherein the sleeve includes one or more pharmacologically active agents and the one or more pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, angiogenic growth factors, bone mending biochemicals, steroids, antisteroids, corticosteroids, antiglacoma agents, antialcohol agents, anti-coagulants agents, genetic material, antithrombolytic agents, anticancer agents, anti-Parkinson agents, antiepileptic agents, anti-inflammatory agents, anticonception agents, enzymes agents, cells, growth factors, antiviral agents, antibacterial agents, antifungal agents, hypoglycemic agents, antihistamine agents, chemoattractants, neutraceuticals, antiobesity, smoking cessation agents, obstetric agents and antiasmatic agents. 
     
     
         20 . The method of  claim 19  wherein the pharmacologically active agents are hydroxyapatite, bone morphogenic protein, VEGF or combinations thereof. 
     
     
         21 . The method of  claim 13  wherein the sleeve and/or particles further comprise one or more biocompatible additives. 
     
     
         22 . The method of  claim 21  wherein the one or more biocompatible additives are selected from the group consisting of epoxies, polyesters, acrylics, nylons, silicones, polyanhydride, polyurethane, polycarbonate, poly(tetrafluoroethylene), polycaprolactone, polyethylene oxide, polyethylene glycol, poly(vinyl chloride), polylactic acid, polyglycolic acid, polypropylene oxide, poly(alkylene)glycol, polyoxyethylene, sebacic acid, polyvinyl alcohol, 2-hydroxyethyl methacrylate, polymethyl methacrylate, 1,3-bis(carboxyphenoxy)propane, lipids, phosphatidylcholine, triglycerides, polyhydroxybutyrate, polyhydroxyvalerate, poly(ethylene oxide), poly ortho esters, poly(amino acids), polycyanoacrylates, polyphophazenes, polysulfone, polyamine, poly(amido amines), fibrin, graphite, flexible fluoropolymer, isobutyl-based, isopropyl styrene, vinyl pyrrolidone, cellulose acetate dibutyrate, silicone rubber, and copolymers of these. 
     
     
         23 . The method of  claim 13  wherein the particles have a size of approximately 10 nm to 5 mm. 
     
     
         24 . The method of  claim 13  wherein the biocompatible proteins of the particles are selected from the group consisting of elastin, collagen, albumin, ovalbumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin, antithrombin III, elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike, elastinlike blocks, collagen-heparin, collagen-elastin-albumin-heparin, collagen-albumin collagen-elastin-heparin and collagen-chondroitin. 
     
     
         25 . The method of  claim 13  wherein the biocompatible solvent of the particles is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols. 
     
     
         26 . The method of  claim 13  wherein the one or more pharmacologically active agents of the particles are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, angiogenic growth factors, bone mending biochemicals, steroids, antisteroids, corticosteroids, antiglacoma agents, antialcohol agents, anti-coagulants agents, genetic material, antithrombolytic agents, anticancer agents, anti-Parkinson agents, antiepileptic agents, anti-inflammatory agents, anticonception agents, enzymes agents, cells, growth factors, antiviral agents, antibacterial agents, antifungal agents, hypoglycemic agents, antihistamine agents, chemoattractants, neutraceuticals, antiobesity, smoking cessation agents, obstetric agents and antiasmatic agents. 
     
     
         27 . The method of  claim 26  wherein the pharmacologically active agents are hydroxyapatite, bone morphogenic protein VEGF or combinations thereof. 
     
     
         28 . The method of  claim 13  wherein the particles further comprise one or more biocompatible additives.