Medical devices, drug coatings and methods for maintaining the drug coatings thereon

• US 20020111590A1
• Filed: 09/25/2001
• Published: 08/15/2002
• Est. Priority Date: 09/29/2000
• Status: Abandoned Application

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Wyeth (Pfizer Inc.)
• Inventors: Narayanan, Pallassana V., Davila, Luis A., Lentz, David Christian, Wilson, David J., Llanos, Gerard H., Roller, Mark B., Shaw, William Douglas Jr., Silver, James H., Trepanier, Christine, Scopelianos, Angelo George, Spaltro, John, Scheidt, Karl K., Pelton, Alan Roy, Mendez, Jorge Orlando
• Application Number:
  US09/962,496
• Publication Number:
  US 20020111590A1
• Time in Patent Office: Days
• US Class Current: 604/265
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/436 : the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/727 : Heparin; Heparan
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 17/145 : Coating
• CPC Class Codes: A61L 2300/416 : Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/608 : having two or more layers
• CPC Class Codes: A61L 2420/02 : Methods for coating medical devices
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 29/085 : Macromolecular materials
• CPC Class Codes: A61L 31/022 : Metals or alloys
• 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: A61L 31/18 : Materials at least partially X-ray or laser opaque
• CPC Class Codes: B05D 1/18 : performed by dipping
• CPC Class Codes: B05D 3/0254 : After-treatment
• CPC Class Codes: B05D 3/0493 : using vacuum
• CPC Class Codes: C08L 27/12 : containing fluorine atoms
• CPC Class Codes: C08L 27/14 : Homopolymers or copolymers of vinyl fluoride
• CPC Class Codes: C08L 27/16 : Homopolymers or copolymers or vinylidene fluoride
• CPC Class Codes: C08L 27/20 : Homopolymers or copolymers of hexafluoropropene

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism'"'"'s reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism'"'"'s reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Claims

1. A medical device for implantation into a treatment site of a living organism, comprising:

a biocompatible vehicle affixed to at least a portion of the medical device; and

at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of reactions by the living organism caused by the medical device or the implantation thereof.

2. The medical device for implantation into a treatment site of a living organism according to claim 1, wherein the biocompatible vehicle comprises a polymeric matrix.

3. The medical device for implantation into a treatment site of a living organism according to claim 2, wherein the polymeric matrix comprises poly(ethylene-co-vinylacetate) and polybutylmethacrylate.

4. The medical device for implantation into a treatment site of a living organism according to claim 2, wherein the polymeric matrix comprises first and second layers, the first layer making contact with at least a portion of the medical device and comprising a solution of poly(ethylene-co-vinylacetate) and polybutylmethacrylate, and the second layer comprising polybutylmethacrylate.

5. The medical device for implantation into a treatment site of a living organism according to claim 4, wherein the at least one agent is incorporated into the first layer.

6. The medical device for implantation into a treatment site of a living organism according to claim 1, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible coating with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.

7. The medical device for implantation into a treatment site of a living organism according to claim 6, wherein the polyfluoro copolymer comprises from about 50 to about 92 weight percent of the polymerized residue of the first moiety copolymerized with from about 50 to about 8 weight percent of the polymerized residue of the second moiety.

8. The medical device for implantation into a treatment site of a living organism according to claim 6, wherein said polyfluoro copolymer comprises from about 50 to about 85 weight percent of polymerized residue of vinylidenefluoride copolymerized with from about 50 to about 15 weight percent of the polymerized residue of the second moiety.

9. The medical device for implantation into a treatment site of a living organism according to claim 6, wherein said copolymer comprises from about 55 to about 65 weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about 45 to about 35 weight percent of the polymerized residue of the second moiety.

10. The medical device for implantation into a treatment site of a living organism according to claim 6, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.

11. The medical device for implantation into a treatment site of a living organism according to claim 6, wherein the second moiety is hexafluoropropylene.

12. The medical device for implantation into a treatment site of a living organism according to claim 1, wherein the at least one agent comprises an anti-proliferative.

13. The medical device for implantation into a treatment site of a living organism according to claim 1, wherein the at least one agent comprises an anti-inflammatory.

14. The medical device for implantation into a treatment site of a living organism according to claim 1, wherein the at least one agent comprises an anti-coagulant.

15. The medical device for implantation into a treatment site of a living organism according to claim 1, wherein the at least one agent comprises rapamycin.

16. The medical device for implantation into a treatment site of a living organism according to claim 1, wherein the at least one agent comprises heparin.

18. The medical device for implantation into a treatment site of a living organism according to claim 17, wherein the biocompatible vehicle comprises a polymeric matrix.

19. The medical device for implantation into a treatment site of a living organism according to claim 18, wherein the polymeric matrix comprises poly(ethylene-co-vinylacetate) and polybutylmethacrylate.

20. The medical device for implantation into a treatment site of a living organism according to claim 18, wherein the polymeric matrix comprises first and second layers, the first layer making contact with at least a portion of the medical device and comprising a solution of poly(ethylene-co-vinylacetate) and polybutylmethacrylate, and the second layer comprising polybutylmethacrylate.

21. The medical device for implantation into a treatment site of a living organism according to claim 20, wherein the at least one agent is incorporated into the first layer.

22. The medical device for implantation into a treatment site of a living organism according to claim 17, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible vehicle with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.

23. The medical device for implantation into a treatment site of a living organism according to claim 22, wherein the polyfluoro copolymer comprises from about 50 to about 92 weight percent of the polymerized residue of the first moiety copolymerized with from about 50 to about 8 weight percent of the polymerized residue of the second moiety.

24. The medical device for implantation into a treatment site of a living organism according to claim 22, wherein said polyfluoro copolymer comprises from about 50 to about 85 weight percent of polymerized residue of vinylidenefluoride copolymerized with from about 50 to about 15 weight percent of the polymerized residue of the second moiety.

25. The medical device for implantation into a treatment site of a living organism according to claim 22, wherein said copolymer comprises from about 55 to about 65 weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about 45 to about 35 weight percent of the polymerized residue of the second moiety.

26. The medical device for implantation into a treatment site of a living organism according to claim 22, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.

27. The medical device for implantation into a treatment site of a living organism according to claim 22, wherein the second moiety is hexafluoropropylene.

28. The medical device for implantation into a treatment site of a living organism according to claim 17, wherein the material for preventing the at least one agent from separating from the medical device comprises a lubricious coating.

29. The medical device for implantation into a treatment site of a living organism according to claim 28, wherein the lubricious coating comprises a silicone-based material.

30. The medical device for implantation into a treatment site of a living organism according to claim 28, wherein the lubricious coating is incorporated into the medical device.

31. The medical device for implantation into a treatment site of a living organism according to claim 28, wherein the lubricious coating is incorporated into the delivery system for the medical device.

32. The medical device for implantation into a treatment site of a living organism according to claim 17, wherein the material for preventing the at least one agent from separating from the medical device comprises a water soluble powder.

33. The medical device for implantation into a treatment site of a living organism according to claim 32, wherein the water soluble powder is incorporated onto the medical device.

34. The medical device for implantation into a treatment site of a living organism according to claim 33, wherein the water soluble powder comprises an anti-oxidant.

35. The medical device for implantation into a treatment site of a living organism according to claim 33, wherein the water soluble powder comprises an anti-coagulant.

37. The medical device for implantation into a treatment site of a living organism according to claim 36, wherein the stent comprises a substantially tubular member having open ends, and a first diameter for insertion into a lumen of a vessel and a second diameter for anchoring in the lumen of the vessel.

38. The medical device for implantation into a treatment site of a living organism according to claim 37, wherein the tubular member comprises a plurality of adjacent hoops formed from a plurality of longitudinal struts and a plurality of loops connecting adjacent struts, the adjacent struts are connected at opposite ends to form a substantially S-shaped pattern, and a plurality of bridges which connect adjacent hoops.

39. The medical device for implantation into a treatment site of a living organism according to claim 38, wherein the biocompatible vehicle comprises a polymeric matrix.

40. The medical device for implantation into a treatment site of a living organism according to claim 39, wherein the polymeric matrix comprises poly(ethylene-co-vinylacetate) and polybutylmethacrylate.

41. The medical device for implantation into a treatment site of a living organism according to claim 39, wherein the polymeric matrix comprises first and second layers, the first layer making contact with at least a portion of the medical device and comprising a solution of poly(ethylene-co-vinylacetate) and polybutylmethacrylate, and the second layer comprising polybutylmethacrylate.

42. The medical device for implantation into a treatment site of a living organism according to claim 41, wherein the at least one agent is incorporated into the first layer.

43. The medical device for implantation into a treatment site of a living organism according to claim 38, wherein the biocompatible vehicle comprises a polyfluoro copolymer copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible coating with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.

44. The medical device for implantation into a treatment site of a living organism according to claim 43, wherein the polyfluoro copolymer comprises from about 50 to about 92 weight percent of the polymerized residue of the first moiety copolymerized with from about 50 to about 8 weight percent of the polymerized residue of the second moiety.

45. The medical device for implantation into a treatment site of a living organism according to claim 43, wherein said polyfluoro copolymer comprises from about 50 to about 85 weight percent of polymerized residue of vinylidenefluoride copolymerized with from about 50 to about 15 weight percent of the polymerized residue of the second moiety.

46. The medical device for implantation into a treatment site of a living organism according to claim 43, wherein said copolymer comprises from about 55 to about 65 weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about 45 to about 35 weight percent of the polymerized residue of the second moiety.

47. The medical device for implantation into a treatment site of a living organism according to claim 43, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.

48. The medical device for implantation into a treatment site of a living organism according to claim 43, wherein the second moiety is hexafluoropropylene.

49. The medical device for implantation into a treatment site of a living organism according to claim 38, wherein the at least one agent comprises an anti-proliferative.

50. The medical device for implantation into a treatment site of a living organism according to claim 38, wherein the at least one agent comprises an anti-inflammatory.

51. The medical device for implantation into a treatment site of a living organism according to claim 38, wherein the at least one agent comprises an anti-coagulant.

52. The medical device for implantation into a treatment site of a living organism according to claim 38, wherein the at least one agent comprises rapamycin.

53. The medical device for implantation into a treatment site of a living organism according to claim 38, wherein the at least one agent comprises heparin.

17. A medical device for implantation into a treatment site of a living organism, comprising:

a biocompatible vehicle affixed to at least a portion of the medical device;

at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of reactions by the living organism caused by the medical device or the implantation thereof; and

a material for preventing the at least one agent for separating from the medical device prior to and during implantation of the medical device at the treatment site, the material being affixed to at least one of the medical device or a delivery system for the medical device.

36. A medical device for implantation into a treatment site of a living organism, comprising:

a stent;

a biocompatible vehicle affixed to at least a portion of the stent; and

at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of reactions by the living organism caused by the medical device or the implantation thereof.

54. A medical device for implantation into a treatment site of a living organism, comprising:

a stent having a substantially tubular member having open ends, and a first diameter for insertion into a lumen of a vessel and a second diameter for anchoring in the lumen of the vessel;

a biocompatible vehicle affixed to at least a portion of the stent;

at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of reactions by the living organism caused by the medical device or the implantation thereof; and

a material for preventing the at least one agent from separating from the medical device prior to and during implantation of the medical device at the treatment site, the material being affixed to at least one of the medical devices or a delivery system for the medical device.

55. The medical device for implantation into a treatment site of a living organism according to claim 54, wherein the tubular member comprises a plurality of adjacent hoops formed from a plurality of longitudinal struts and a plurality of loops connecting adjacent struts, the adjacent struts are connected at opposite ends to form a substantially S-shaped pattern, and a plurality of bridges which connect adjacent hoops.

56. The medical device for implantation into a treatment site of a living organism according to claim 55, wherein the stent comprises a superelastic alloy.

57. The medical device for implantation into a treatment site of a living organism according to claim 56, wherein the superelastic alloy comprises from about fifty percent to about sixty percent Nickel and the remainder Titanium.

58. The medical device for implantation into a treatment site of a living organism according to claim 57, wherein the biocompatible coating comprises a polymeric matrix.

59. The medical device for implantation into a treatment site of a living organism according to claim 58, wherein the polymeric matrix comprises poly(ethylene-co-vinylacetate) and polybutylmethacrylate.

60. The medical device for implantation into a treatment site of a living organism according to claim 58, wherein the polymeric matrix comprises first and second layers, the first layer making contact with at least a portion of the medical device and comprising a solution of poly(ethylene-co-vinylacetate) and polybutylmethacrylate, and the second layer comprising polybutylmethacrylate.

61. The medical device for implantation into a treatment site of a living organism according to claim 60, wherein the at least one agent is incorporated into the first layer.

62. The medical device for implantation into a treatment site of a living organism according to claim 57, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible coating with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.

63. The medical device for implantation into a treatment site of a living organism according to claim 62, wherein the polyfluoro copolymer comprises from about 50 to about 92 weight percent of the polymerized residue of the first moiety copolymerized with from about 50 to about 8 weight percent of the polymerized residue of the second moiety.

64. The medical device for implantation into a treatment site of a living organism according to claim 62, wherein said polyfluoro copolymer comprises from about 50 to about 85 weight percent of polymerized residue of vinylidenefluoride copolymerized with from about 50 to about 15 weight percent of the polymerized residue of the second moiety.

65. The medical device for implantation into a treatment site of a living organism according to claim 62, wherein said copolymer comprises from about 55 to about 65 weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about 45 to about 35 weight percent of the polymerized residue of the second moiety.

66. The medical device for implantation into a treatment site of a living organism according to claim 62, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.

67. The medical device for implantation into a treatment site of a living organism according to claim 62, wherein the second moiety is hexafluoropropylene.

68. The medical device for implantation into a treatment site of a living organism according to claim 55, wherein the at least one agent comprises an anti-proliferative.

69. The medical device for implantation into a treatment site of a living organism according to claim 55, wherein the at least one agent comprises an anti-inflammatory.

70. The medical device for implantation into a treatment site of a living organism according to claim 55, wherein the at least one agent comprises an anti-coagulant.

71. The medical device for implantation into a treatment site of a living organism according to claim 55, wherein the at least one agent comprises rapamycin.

72. The medical device for implantation into a treatment site of a living organism according to claim 55, wherein the at least one agent comprises heparin.

73. The medical device for implantation into a treatment site of a living organism according to claim 55, wherein the material for preventing the at least one agent from separating from the medical device comprises a lubricious coating.

74. The medical device for implantation into a treatment site of a living organism according to claim 73, wherein the lubricious coating comprises a silicone-based material.

75. The medical device for implantation into a treatment site of a living organism according to claim 73, wherein the lubricious coating is incorporated into the medical device.

76. The medical device for implantation into a treatment site of a living organism according to claim 73, wherein the lubricious coating is incorporated into the delivery system for the medical device.

77. The medical device for implantation into a treatment site of a living organism according to claim 55, wherein the material for preventing the at least one agent from separating from the medical device comprises a water soluble powder.

78. The medical device for implantation into a treatment site of a living organism according to claim 77, wherein the water soluble powder is incorporated onto the medical device.

79. The medical device for implantation into a treatment site of a living organism according to claim 78, wherein the water soluble powder comprises an anti-oxidant.

80. The medical device for implantation into a treatment site of a living organism according to claim 78, wherein the water soluble powder comprises an anti-coagulant.

81. The medical device for implantation into a treatment site of a living organism according to claim 75, wherein the lubricious coating is incorporated into the polymeric matrix.

82. The medical device for implantation into a treatment site of a living organism according to claim 78, wherein the water soluble powder is affixed to the surface of the polymeric matrix.

83. The medical device for implantation into a treatment site of a living organism according to claim 57, further comprises at least one marker connected to at least one end of the substantially tubular member, the at least one marker comprising a marker housing and a marker insert having a radius of curvature equal to the radius of curvature of the substantially tubular member.

84. The medical device for implantation into a treatment site of a living organism according to claim 83, wherein the marker housing comprises the same material as the stent and is integral thereto, thereby forming a unitary structure.

85. The medical device for implantation into a treatment site of a living organism according to claim 84, wherein the marker insert comprises a material having a radiopacity higher than that of the material comprising the stent.

86. The medical device for implantation into a treatment site of a living organism according to claim 85, wherein the marker insert comprises Tantalum.

87. The medical device for implantation into a treatment site of a living organism according to claim 86, wherein the marker insert is secured in the marker housing by frictional, locking engagement.

88. The medical device for implantation into a treatment site of a living organism according to claim 87, wherein the marker insert is secured in the marker housing by a protruding ridge.

90. The local drug delivery device according to claim 89, wherein from about fifty micrograms to about one thousand micrograms of rapamycin is provided per square centimeter of the lumen into which the stent is anchored.

91. The local drug delivery device according to claim 89, wherein the polymeric coating comprises a combination of vinylidene fluoride and hexafluoropropylene.

92. The local drug delivery device according to claim 91, wherein the polymeric coating weight is in the range from about two hundred to about one thousand seven hundred micrograms per square centimeter of the lumen into which the stent is anchored.

89. A local drug delivery device comprising:

a stent having a substantially tubular member having open ends, and a first diameter for insertion into a lumen of a vessel and a second diameter for anchoring in the lumen of a vessel;

a biocompatible polymeric vehicle affixed to at least a portion of the stent; and

rapamycin, in therapeutic dosages, incorporated into the polymeric vehicle.

93. A method of coating a medical device with a therapeutic agent comprising the steps of:

creating a polymer utilizing vinylidene fluoride and hexafluoropropylene in a batch emulsion polymerization process;

priming the medical device with the polymer utilizing a dip coating process;

creating a polymer and therapeutic agent mixture;

applying the polymer and therapeutic agent mixture on the primer layer utilizing a spin coating process; and

drying the medical device in a vacuum oven for approximately sixteen hours at a temperature in the range of fifty to sixty degrees centigrade.

94. A medical device for implantation into a treatment site of a living organism, comprising:

a biocompatible vehicle affixed to at least a portion of the medical device; and

at least one agent incorporated into the biocompatible vehicle, the at least one agent being designed to react with one or more chemicals produced by the living organism to treat reactions by the living organism caused by the medical device or the implantation thereof.

95. A medical device for implantation into the vasculature of a living organism, comprising:

a self-expanding stent;

a biocompatible vehicle affixed to at least a portion of the stent; and

rapamycin, in therapeutic dosages, incorporated into the biocompatible vehicle for the prevention of restenosis.

96. A method of coating a medical device with a therapeutic agent comprising the steps of:

creating a polymer utilizing vinylidene fluoride and hexafluoropropylene;

adding one or more therapeutic agents to the polymer to create a polymer and therapeutic agent mixture; and

applying the polymer and therapeutic agent mixture to the medical device.

97. A medical device for implantation into a treatment site of a living organism, comprising:

a biocompatible vehicle affixed to at least a portion of the medical device;

at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of disease proximate the implantation site.

98. A medical device for implantation into a treatment site of a living organism, comprising:

a biocompatible vehicle affixed to at least a portion of the medical device;

at least one agent in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of disease remote from the implantation site.

99. A method of coating a medical device with a therapeutic agent comprising the steps of:

creating a polymer utilizing vinylidene fluoride and hexafluoropropylene in a batch dispersion polymerization process;

priming the medical device with the polymer utilizing a dip coating process;

creating a polymer and therapeutic agent mixture;

applying the polymer and therapeutic agent mixture on the primer layer utilizing a spin coating process; and

drying the medical device in a vacuum oven for approximately sixteen hours at a temperature in the range of fifty to sixty degrees centigrade.