CA2401385A1 - Protein matrix materials, devices and methods of making and using thereof - Google Patents

Protein matrix materials, devices and methods of making and using thereof Download PDF

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CA2401385A1
CA2401385A1 CA002401385A CA2401385A CA2401385A1 CA 2401385 A1 CA2401385 A1 CA 2401385A1 CA 002401385 A CA002401385 A CA 002401385A CA 2401385 A CA2401385 A CA 2401385A CA 2401385 A1 CA2401385 A1 CA 2401385A1
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agents
biocompatible
matrix material
protein matrix
poly
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CA2401385C (en
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David B. Masters
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Gel Del Technologies Inc
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    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00—Preparations for dentistry
    • A61K6/80—Preparations for artificial teeth, for filling teeth or for capping teeth
    • A61K6/884—Preparations for artificial teeth, for filling teeth or for capping teeth comprising natural or synthetic resins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
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    • A61K9/2063—Proteins, e.g. gelatin
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    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
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    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0009—Galenical forms characterised by the drug release technique; Application systems commanded by energy involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis
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    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

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Abstract

The present invention relates to protein matrix materials and devices and the methods of making and using protein matrix materials and devices. More specifically the present invention relates to protein matrix materials and devices that may be utilized for various medical applications including, but not limited to, drug delivery devices for the controlled release of pharmacologically active agents, encapsulated or coated stent devices, vessels, tubular grafts, vascular grafts, wound healing devices including protein matrix suture material and meshes, skin/bone/tissue grafts, biocompatible electricity conducting matrices, clear protein matrices, protein matrix adhesion prevention barriers, cell scaffolding and other biocompatible protein matrix devices. Furthermore, the present invention relates to protein matrix materials and devices made by forming a film comprising one or more biodegradable protein materials, one or more biocompatible solvents and optionally one or more pharmacologically active agents. The film is then partially dried, rolled or otherwise shaped, and then compressed to form the desired protein matrix device.

Claims (140)

1. A protein matrix material comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form an interacting protein matrix material.
2. A protein matrix material comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form a matrix material wherein the compression of the protein material and the solvent material generates additional interactive forces.
3. The protein matrix material of claim 1 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.
4. The protein matrix material of claim 3 wherein the biocompatible proteins is a natural protein selected from the group consisting of elastin, collagen, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin and antithrombin III.
5. The protein matrix material of claim 1 wherein the biocompatible proteins is a genetically engineered protein made of blocks selected from the group consisting of elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike and elastinlike blocks.
6. The protein matrix material 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.
7. The protein matrix material of claim 6 wherein the biocompatible solvent is water.
8. The protein matrix material of claim 1 further comprising one or more pharmacologically active agents.
9. The protein matrix material of claim 8 wherein the one or more pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, 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.
10. The method of claim 8, wherein the pharmacologically active agent comprises a second, migration-vulnerable drug delivery device.
11. The method of claim 10, wherein the migration-vulnerable drug delivery device comprises a plurality of lipospheres homogeneously dispersed within the drug delivery device.
12. The method of claim 8, wherein the migration-vulnerable drug delivery device comprises a plurality of microspheres homogeneously dispersed within the protein matrix material.
13. The method of claim 1, wherein the pharmacologically active agent is substantially homogeneously distributed within the protein matrix material.
14. The protein matrix material of claim 1 further comprising one or more biocompatible polymeric materials.
15. The protein matrix material of claim 8 further comprising one or more biocompatible polymeric materials.
16. The protein matrix material of claim 1 wherein the one or more biocompatible polymeric materials are selected from the group consisting of epoxies, polyesters, acrylics, nylons, silicones, polyanhydride, polyurethane, polycarbonate, poly(tetrafluoroethylene), polycaprolactone, polyethylene oxide, polyethylene glycol, polyvinyl chloride), polylactic acid, polyglycolic acid, polypropylene oxide, poly(akylene)glycol, polyoxyethylene, sebacic acid, polyvinyl alcohol, 2-hydroxyethyl methacrylate, polymethyl methacrylate, 1,3-bis(carboxyphenoxy)propane, lipids, phosphatidylcholine, triglycerides, polyhydroxybutyrate, polyhydroxyvalerate, polyethylene oxide), poly ortho esters, poly (amino acids), polycynoacrylates, 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.
17. The protein matrix material of claim 8 wherein the one or more biocompatible polymeric materials are selected from the group consisting of epoxies, polyesters, acrylics, nylons, silicones, polyanhydride, polyurethane, polycarbonate, poly(tetrafluoroethylene), polycaprolactone, polyethylene oxide, polyethylene glycol, polyvinyl chloride), polylactic acid, polyglycolic acid, polypropylene oxide, poly(akylene)glycol, polyoxyethylene, sebacic acid, polyvinyl alcohol, 2-hydroxyethyl methacrylate, polymethyl methacrylate, 1,3-bis(carboxyphenoxy)propane, lipids, phosphatidylcholine, triglycerides, polyhydroxybutyrate, polyhydroxyvalerate, polyethylene oxide), poly ortho esters, poly (amino acids), polycynoacrylates, 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.
18. The protein matrix material of claim 1 wherein the protein matrix material is crosslinked with one or more crosslinking agents.
a
19. The protein matrix material of claim 8 wherein the protein matrix material is crosslinked with one or more crosslinking agents.
20. The protein matrix material of claim 18 wherein the one or more crosslinking reagents are selected from the group consisting of glutaraldehyde, p-Azidobenzolyl Hydazide, N-5-Azido-2-nitrobenzoyloxysuccinimide, N-Succinimidyl 6-[4'azido-2'nitro-phenylamino]hexanoate and 4-[p-Azidosalicylamido] butylamine.
21. The protein matrix material of claim 19 wherein the one or more crosslinking reagents are selected from the group consisting of glutaraldehyde, p-Azidobenzolyl Hydazide, N-5-Azido-2-nitrobenzoyloxysuccinimide, N-Succinimidyl 6-[4'azido-2'nitro-phenylamino]hexanoate and 4-[p-Azidosalicylamido] butylamine.
22. A protein matrix material comprising one or more biocompatible protein materials and one or more biocompatible solvents made by the steps comprising:

(a) preparing a coatable composition including the one or more biocompatible protein materials, and the one or more biocompatible solvents;
(b) coating the composition to form a film;
(c) partially drying the coated film until the coated film can be formed into a cohesive body;
(d) forming said cohesive body; and compressing the cohesive body to form a protein matrix material
23. The protein matrix material of claim 22 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.
24. The protein matrix material of claim 22 wherein the biocompatible proteins is a natural protein selected from the group consisting of elastin, collagen, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin and antithrombin III.
25. The protein matrix material of claim 23 wherein the biocompatible proteins are genetically engineered proteins made of blocks selected from the group consisting of elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike and elastinlike blocks.
26. The protein matrix material of claim 22 wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.
27. The protein matrix material of claim 26 wherein the biocompatible solvent is water.
28. The protein matrix material of claim 22 further comprising one or more pharmacologically active agents.
29. The protein matrix material of claim 28 wherein the one or more pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, anti psychotic agents, 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 and antiasmatic agents.
30. The protein matrix material of claim 28, wherein the pharmacologically active agent comprises a second, migration-vulnerable drug delivery device.
31. The protein matrix material of claim 30, wherein the migration-vulnerable drug delivery device comprises a plurality of lipospheres homogeneously dispersed within the protein matrix material.
32. The protein matrix material of claim 28, wherein the migration-vulnerable drug delivery device comprises a plurality of microspheres homogeneously dispersed within the protein matrix material.
33. The protein matrix material of claim 28, wherein the pharmacologically active agent is substantially homogeneously distributed within the protein matrix material.
34. The protein matrix material of claim 22 further comprising one or more biocompatible polymeric materials.
35. The protein matrix material of claim 28 further comprising one or more biocompatible polymeric materials.
36. The protein matrix material of claim 34 wherein the one or more biocompatible polymeric materials 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(akylene)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), polycynoacrylates, 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.
37. The protein matrix material of claim 28 wherein the one or more biocompatible polymeric materials 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(akylene)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 orthoesters, poly (amino acids), polycynoacrylates, 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.
38. The protein matrix material of claim 22 wherein the protein matrix material is crosslinked with one or more crosslinking agents.
39. The protein matrix material of claim 28 wherein the protein matrix material is crosslinked with one or more crosslinking agents.
40. The protein matrix material of claim 38 wherein the 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-phenylamino]hexanoate and 4-[p-Azidosalicylamido] butylamine.
41. The protein matrix material of claim 39 wherein the one or more crosslinking reagents are selected from the group consisting of glutaraldehyde, p-Azidobenzolyl Hydazide, N-5-Azido-2-nitrobenzoyloxysuccinimide, N-Succinimidyl 6-[4'azido-2'nitro-phenylamino]hexanoate and 4-[p-Azidosalicylamido] butylamine.
42. A method of making a protein matrix material, comprising the steps of (a) preparing a coatable composition comprising one or more biocompatible protein materials and one or more biocompatible solvents;
(b) coating the composition to form a film;
(c) partially drying the coated film until the coated film can be formed into a cohesive body;
(d) forming said cohesive body; and compressing the cohesive body to form a protein matrix material.
43. The method of making a protein matrix material of claim 42 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.
44. The method of making a protein matrix material of claim 43 wherein the biocompatible proteins is a natural protein selected from the group consisting of elastin, collagen, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin and antithrombin III.
45. The method of making a protein matrix material of claim 43 wherein the biocompatible proteins is a genetically engineered protein made of blocks selected from the group consisting of elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike and elastinlike blocks.
46. The method of making a protein matrix material of claim 42 wherein. the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocornpatible alcohols, biocompatible acids, oils and biocompatible glycols.
47. The method of making a protein matrix material of claim 46 wherein the biocompatible solvent is water.
48. The method of making a protein matrix material of claim 42 further comprising one or more pharmacologically active agents.
49. The method of making a protein matrix material of claim 48 wherein the one or more pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, 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.
50. The method of making a protein matrix material of claim 48, wherein the pharmacologically active agent comprises a second, migration-vulnerable drug delivery device.
51. The method of making a protein matrix material of claim 50, wherein the migration-vulnerable drug delivery device comprises a plurality of lipospheres homogeneously dispersed within the drug delivery device.
52. The method of making a protein matrix material of claim 48, wherein the migration-vulnerable drug delivery device comprises a plurality of microspheres homogeneously dispersed within the protein matrix material.
53. The method of making a protein matrix material of claim 42, wherein the pharmacologically active agent is substantially homogeneously distributed within the protein matrix material.
54. The method of making a protein matrix material of claim 1 further comprising one or more biocompatible polymeric materials.
55. The method of making a protein matrix material of claim 48 further comprising one or more biocompatible polymeric materials.
56. The method of making a protein matrix material of claim 42 further comprising the step of crosslinking the protein matrix material with a suitable crosslinking agent.
57. The method of making a protein matrix material of claim 48 further comprising the step of crosslinking the protein matrix material with a suitable crosslinking agent.
58. A drug delivery device comprising one or more biocompatible protein materials compressed with one or more pharmacologically active agents and one or more biocompatible solvents to remove bulk solvent and form an interacting drug delivery device.
59. A drug delivery device comprising one or more biocompatible protein materials compressed with one or more pharmacologically active agents and one or more biocompatible solvents to remove bulk solvent and form a drug delivery device wherein the compression of the protein material and the pharmacologically active agents and solvent material generates additional interactive forces.
60. The drug delivery device of claim 58 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.
61. The drug delivery device of claim 60 wherein the biocompatible proteins is a natural protein selected from the group consisting of elastin, collagen, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin and antithrombin III.
62. The drug delivery device of claim 60 wherein the biocompatible proteins is a genetically engineered protein made of blocks selected from the group consisting of elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike and elastinlike blocks.
63. The drug delivery device of claim 58 wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.
64. The drug delivery device of claim 63 wherein the biocompatible solvent is water.
65. The drug delivery device of claim 58 wherein the one or more pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, 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.
66. The drug delivery device of claim 58, wherein the pharmacologically active agent comprises a second, migration-vulnerable drug delivery device.
67. The drug delivery device of claim 66, wherein the migration-vulnerable drug delivery device comprises a plurality of lipospheres homogeneously dispersed within the drug delivery device.
68. The drug delivery device of claim 66, wherein the migration-vulnerable drug delivery device comprises a plurality of microspheres homogeneously dispersed within the protein matrix material.
69. The drug delivery device of claim 58, wherein the pharmacologically active agent is substantially homogeneously distributed within the protein matrix material.
70. The drug delivery device of claim 58 further comprising one or more biocompatible polymeric materials.
71. The drug delivery device of claim 58 wherein the drug delivery device is crosslinked with one or more crosslinking agents.
72. The drug delivery device of claim 58 wherein the drug delivery device is produced in particulate form.
73. The drug delivery device of claim 58 wherein the pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, 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.
74. The drug delivery device of claim 72 wherein the pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, 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.
75. A wound healing device comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form an interacting wound healing device.
76. A wound healing device comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form a wound healing device wherein the compression of the protein material and the solvent material generates additional interactive forces.
77. The wound healing device of claim 75 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.
78. The wound healing device of claim 75 wherein the biocompatible proteins are natural proteins selected from the group consisting of elastin, collagen, albumin, keratin, f bronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin and antithrombin III.
79. The wound healing device of claim 75 wherein the biocompatible proteins are genetically engineered proteins made of blocks selected from the group consisting of elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike and elastinlike blocks.
80. The wound healing device of claim 75 wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.
81. The wound healing device of claim 80 wherein the biocompatible solvent is water.
82. The wound healing device of claim 75 further comprising one or more pharmacologically active agents.
83. The wound healing device of claim 82 wherein the one or more pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, 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.
84. The wound healing device of claim 82, wherein the pharmacologically active agent comprises a second, migration-vulnerable drug delivery device.
85. The wound healing device of claim 84, wherein the migration-vulnerable drug delivery device comprises a plurality of lipospheres homogeneously dispersed within the drug delivery device.
86. The wound healing device of claim 84, wherein the migration-vulnerable drug delivery device comprises a plurality of microspheres homogeneously dispersed within the protein matrix material.
87. The wound healing device of claim 75 further comprising one or more biocompatible polymeric materials.
88. The wound healing device of claim 82 further comprising one or more biocompatible polymeric materials.
89. The wound healing device of claim 87 wherein the one or more biocompatible polymeric materials 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(akylene)glycol, polyoxyethylene, sebacic acid, polyvinyl alcohol, 2-hydroxyethyl methacrylate, polymethyl methacrylate, 1,3-bis(carboxyphenoxy)propane, lipids, phosphatidylcholine, triglycerides, polyhydroxybutyrate, polyhydroxyvalerate, polyethylene oxide), poly ortho esters, poly (amino acids), polycynoacrylates, 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.
90. The wound healing device of claim 88 wherein the one or more biocompatible polymeric materials 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(akylene)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), polycynoacrylates, 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.
91. The wound healing device of claim 75 wherein the wound healing device is crosslinked with one or more crosslinking agents.
92. The wound healing device of claim 82 wherein the wound healing device is crosslinked with one or more crosslinking agents.
93. The wound healing device of claim 75 wherein the wound healing device is selected from the group consisting of bone inserts, meshes, strips, sutures, dental plugs, skin dressings, bandages, tissue plugs, vertebrae inserts, vertebral discs, joints, bronchial tissue inserts, abdominal inserts, vascular inserts and port seals.
94 The wound healing device of claim 82 wherein the bandage comprises a segment of protein matrix material positioned on a non-adhesive strip adjoined to adhesive ends.
95. The wound healing device of claim 82 wherein the wound healing device includes a patch delivery system adjoined behind the protein matrix dressing for delivery of additional pharmacologically active agents.
96. A tissue graft comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form an interacting tissue graft.
97. A tissue graft comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form a tissue graft wherein the compression of the protein material and the solvent material generates additional interactive forces.
98. The tissue graft of claim 96 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.
99. The tissue graft of claim 97 wherein the biocompatible proteins are natural proteins selected from the group consisting of elastin, collagen, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin and antithrombin III.
100. The tissue graft of claim 96 wherein the biocompatible proteins are genetically engineered proteins made of blocks selected from the group consisting of elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike and elastinlike blocks.
101. The tissue graft of claim 96 wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.
102. The tissue graft of claim 101 wherein the biocompatible solvent is water.
103. The tissue graft of claim 96 further comprising one or more pharmacologically active agents.
104. The tissue graft of claim 103 wherein the one or more pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, 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.
105. The tissue graft of claim 103, wherein the pharmacologically active agent comprises a second, migration-vulnerable drug delivery device.
106. The tissue graft of claim 105, wherein the migration-vulnerable drug delivery device comprises a plurality of lipospheres homogeneously dispersed within the drug delivery device.
107. The tissue graft of claim 105, wherein the migration-vulnerable drug delivery device comprises a plurality of microspheres homogeneously dispersed within the protein matrix material.
108. The tissue graft of claim 96 further comprising one or more biocompatible polymeric materials.
109. The tissue graft of claim 103 further comprising one or more biocompatible polymeric materials.
110. The tissue graft of claim 108 wherein the one or more biocompatible polymeric materials 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(akylene)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), polycynoacrylates, 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.
111. The tissue graft of claim 109 wherein the one or more biocompatible polymeric materials are selected from the group consisting of epoxies, polyesters, acrylics, nylons, silicones, polyanhydride, polyurethane, polycarbonate, poly(tetrafluoroethylene), polycaprolactone, polyethylene oxide, polyethylene glycol, polyvinyl chloride), polylaetic acid, polyglycolic acid, polypropylene oxide, poly(akylene)glycol, polyoxyethylene, sebacic acid, polyvinyl alcohol, 2-hydroxyethyl methacrylate, polymethyl methacrylate, 1,3-bis(carboxyphenoxy)propane, lipids, phosphatidylcholine, triglycerides, polyhydroxybutyrate, polyhydroxyvalerate, polyethylene oxide), poly ortho esters, poly (amino acids), polycynoacrylates, 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.
112. The tissue graft of claim 96 wherein the tissue graft is crosslinked with one or more crosslinking agents.
113. The tissue graft of claim 103 wherein the tissue graft is crosslinked with one or more crosslinking agents.
114. The tissue graft of claim 96 wherein the tissue graft are selected from the group consisting of vessels, tubular grafts, tracheal tubes, bronchial tubes, catheter functioning tubes, lung grafts, gastrointestinal segments; clear matrix grafts; heart valves;
cartilage; tendons;
ligaments, skin grafts and pancreatic implant devices.
115. The tissue graft of claim 103 wherein the tissue graft are selected from the group consisting of vessels, tubular grafts, tracheal tubes, bronchial tubes, catheter functioning tubes, lung grafts, gastrointestinal segments; clear matrix grafts; heart valves;
cartilage; tendons;
ligaments, skin grafts and pancreatic implant devices.
116. The wound healing device of claim 83 wherein the wound healing device is selected from the group consisting of bone inserts, meshes, strips, sutures, dental plugs, skin dressings, bandages, tissue plugs, vertebrae inserts, vertebral discs, joints, bronchial tissue inserts, abdominal inserts, vascular inserts and port seals.
117. An encapsulated or coated stent device comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form an interacting encapsulated or coated stent device.
118. An encapsulated or coated stent device comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form a encapsulated or coated stent device wherein the compression of the protein material and the solvent material generates additional interactive forces.
119. The encapsulated or coated stent device of claim 116 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.
120. The encapsulated or coated stent device of claim 118 wherein the biocompatible proteins are natural proteins selected from the group consisting of elastin, collagen, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin and antithrombin III.
121. The encapsulated or coated stent device of claim 116 wherein the biocompatible proteins are genetically engineered proteins made of blocks selected from the group consisting of elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks and silklike and elastinlike blocks.
122. The encapsulated or coated stent device of claim 116 wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.
123. The encapsulated or coated stent device of claim 121 wherein the biocompatible solvent is water.
124. The encapsulated or coated stent device of claim 116 further comprising one or more pharmacologically active agents.
125. The encapsulated or coated stent device of claim 123 wherein the one or more pharmacologically active agents are selected from the group consisting of analgesics, anesthetics, antipsychotic agents, steroids, antisteroids, corticosteroids, antiglacorna 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.
126. The encapsulated or coated stent device of claim 123, wherein the pharmacologically active agent comprises a second, migration-vulnerable drug delivery device.
127. The encapsulated or coated stent device of claim 125, wherein the migration-vulnerable drug delivery device comprises a plurality of lipospheres homogeneously dispersed within the drug delivery device.
128. The encapsulated or coated stent device of claim 125, wherein the migration-vulnerable drug delivery device comprises a plurality of microspheres homogeneously dispersed within the protein matrix material.
129. The encapsulated or coated stent device of claim 116 further comprising one or more biocompatible polymeric materials.
130. The encapsulated or coated stent device of claim 123 further comprising one or more biocompatible polymeric materials.
131. The encapsulated or coated stent device of claim 128 wherein the one or more biocompatible polymeric materials 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(akylene)glycol, polyoxyethylene, sebacic acid, polyvinyl alcohol, 2-hydroxyethyl methacrylate, polymethyl methacrylate, 1,3-bis(carboxyphenoxy)propane, lipids, phosphatidylcholine, triglycerides, polyhydroxybutyrate, polyhydroxyvalerate, polyethylene oxide), poly ortho esters, poly (amino acids), polycynoacrylates, 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.
132. The encapsulated or coated stent device of claim 129 wherein the one or more biocompatible polymeric materials are selected from the group consisting of epoxies, polyesters, acrylics, nylons, silicones, polyanhydride, polyurethane, polycarbonate, poly(tetrafluoroethylene), polycaprolactone, polyethylene oxide, polyethylene glycol, polyvinyl chloride), polylactic acid, polyglycolic acid, polypropylene oxide, poly(akylene)glycol, polyoxyethylene, sebacic acid, polyvinyl alcohol, 2-hydroxyethyl methacrylate, polymethyl methacrylate, 1,3-bis(caxboxyphenoxy)propane, lipids, phosphatidylcholine, triglycerides, polyhydroxybutyrate, polyhydroxyvalerate, polyethylene oxide), poly ortho esters, poly (amino .
acids), polycynoacrylates, 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.
133. The encapsulated or coated stent device of claim 116 wherein the encapsulated or coated stent device is crosslinked with one or more crosslinking agents.
134. The encapsulated or coated stent device of claim 123 wherein the encapsulated or coated stent device is crosslinked with one or more crosslinking agents.
135. The drug delivery device of claim 58 further comprising a release mechanism that releases the pharmacologically active agent upon contact with an outside stimuli.
136. A protein matrix IUD comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form an interacting protein matrix IUD.
137. The protein matrix IUD of claim 135 further including one or more pharmacologically active agents.
138. An image marker comprising one or more biocompatible protein materials compressed with one or more biocompatible solvents to remove bulk solvent and form an interacting image marker.
139. The protein matrix material of claim 17, wherein the matrix material is imprinted by crosslinking in a predetermined pattern utilizing masking or UV light activated reagents.
140. The protein matrix material of claim 18, wherein the matrix material is imprinted by crosslinking in a predetermined pattern utilizing masking or UV light activated reagents.
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