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

• US 20020028243A1
• Filed: 02/28/2001
• Published: 03/07/2002
• Est. Priority Date: 09/25/1998
• Status: Active Grant

• Current Assignee: PetVivo Holdings, Inc.
• Original Assignee: Gel-Del Technologies, Inc. (PetVivo Holdings, Inc.)
• Inventors: Masters, David B.
• Granted Patent: US 7,662,409 B2
• Time in Patent Office: Days
• US Class Current: 424/484
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C08L 89/00 Compositions of proteins; Compositions of derivatives thereof foodstuff preparations A23J3/00
• CPC Class Codes: Y10S 623/915 Method or apparatus for preparing biological material

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

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.

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 protein matrix material of claim 1 further comprising one or more biocompatible polymeric materials.

14. The protein matrix material of claim 8 further comprising one or more biocompatible polymeric materials.

15. 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, 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.

16. 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, 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.

17. The protein matrix material of claim 1 wherein the protein matrix material is crosslinked with one or more crosslinking agents.

18. The protein matrix material of claim 8 wherein the protein matrix material is crosslinked with one or more crosslinking agents.

19. The protein matrix material of claim 17 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.

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.

88. 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.

89. 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.

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.

21. 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

(e) compressing the cohesive body to form a protein matrix material.

22. The method of making a protein matrix material of claim 21 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.

23. The method of making a 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.

24. The method of making a protein matrix material of claim 22 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.

25. The method of making a protein matrix material of claim 21 wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.

26. The method of making a protein matrix material of claim 25 wherein the biocompatible solvent is water.

27. The method of making a protein matrix material of claim 21 further comprising one or more pharmacologically active agents.

28. The method of making a protein matrix material of claim 27 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.

29. The method of making a protein matrix material of claim 21 further comprising one or more biocompatible polymeric materials.

30. The method of making a protein matrix material of claim 27 further comprising one or more biocompatible polymeric materials.

31. The method of making a protein matrix material of claim 21 further comprising the step of crosslinking the protein matrix material with a suitable crosslinking agent.

32. The method of making a protein matrix material of claim 27 further comprising the step of crosslinking the protein matrix material with a suitable crosslinking agent.

33. 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.

34. The drug delivery device of claim 33 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.

35. The drug delivery device of claim 33 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.

36. The drug delivery device of claim 34 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.

37. The drug delivery device of claim 33 wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.

38. The drug delivery device of claim 33 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.

39. The drug delivery device of claim 33 further comprising one or more biocompatible polymeric materials.

40. The drug delivery device of claim 33 wherein the drug delivery device is crosslinked with one or more crosslinking agents.

41. The drug delivery device of claim 33 wherein the drug delivery device is produced in particulate form.

42. The drug delivery device of claim 33 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.

43. 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.

44. The wound healing device of claim 43 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.

45. The wound healing device of claim 44 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.

46. The wound healing device of claim 44 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.

47. The wound healing device of claim 43 wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.

48. The wound healing device of claim 43 further comprising one or more pharmacologically active agents.

49. The wound healing device 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 wound healing device of claim 43 further comprising one or more biocompatible polymeric materials.

51. The wound healing device of claim 48 further comprising one or more biocompatible polymeric materials.

52. The wound healing device of claim 43 wherein the wound healing device is crosslinked with one or more crosslinking agents.

53. The wound healing device of claim 48 wherein the wound healing device is crosslinked with one or more crosslinking agents.

54. The wound healing device of claim 43 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.

55. The wound healing device of claim 54 wherein the bandage comprises a segment of protein matrix material positioned on a non-adhesive strip adjoined to adhesive ends.

56. The wound healing device of claim 55 wherein the wound healing device includes a patch delivery system adjoined to the protein matrix dressing for delivery of additional pharmacologically active agents.

58. The tissue graft of claim 57 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.

59. The tissue graft of claim 58 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.

60. The tissue graft of claim 58 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.

61. The tissue graft of claim 57 wherein the one or more biocompatible solvents are selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.

62. The tissue graft of claim 57 further comprising one or more pharmacologically active agents.

63. The tissue graft of claim 62 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.

64. The tissue graft of claim 57 further comprising one or more biocompatible polymeric materials.

65. The tissue graft of claim 62 further comprising one or more biocompatible polymeric materials.

66. The tissue graft of claim 64 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.

67. The tissue graft of claim 65 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.

68. The tissue graft of claim 57 wherein the tissue graft is crosslinked with one or more crosslinking agents.

69. The tissue graft of claim 62 wherein the tissue graft is crosslinked with one or more crosslinking agents.

70. The tissue graft of claim 57 wherein the tissue graft is 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.

84. The drug delivery device of claim 43 further comprising a release mechanism that releases the pharmacologically active agent upon contact with an outside stimuli.

57. 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.

71. 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.

72. The encapsulated or coated stent device of claim 71 wherein the biocompatible proteins may be natural, synthetic or genetically engineered.

73. The encapsulated or coated stent device of claim 72 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.

74. The encapsulated or coated stent device of claim 72 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.

75. The encapsulated or coated stent device of claim 71 wherein the biocompatible solvent is selected from the group consisting of water, dimethyl sulfoxide (DMSO), biocompatible alcohols, biocompatible acids, oils and biocompatible glycols.

76. The encapsulated or coated stent device of claim 71 further comprising one or more pharmacologically active agents.

77. The encapsulated or coated stent device of claim 76 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.

78. The encapsulated or coated stent device of claim 71 further comprising one or more biocompatible polymeric materials.

79. The encapsulated or coated stent device of claim 76 further comprising one or more biocompatible polymeric materials.

80. The encapsulated or coated stent device of claim 78 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.

81. The encapsulated or coated stent device of claim 79 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.

82. The encapsulated or coated stent device of claim 71 wherein the encapsulated or coated stent device is crosslinked with one or more crosslinking agents.

83. The encapsulated or coated stent device of claim 76 wherein the encapsulated or coated stent device is crosslinked with one or more crosslinking agents.

85. 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.

86. The protein matrix IUD of claim 85 further including one or more pharmacologically active agents.

87. 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.