Coated implantable medical device

• US 20060195176A1
• Filed: 04/25/2006
• Published: 08/31/2006
• Est. Priority Date: 06/07/1995
• Status: Abandoned Application

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Bates, Brian L., Fearnot, Neal E., Kozma, Thomas G., Ragheb, Anthony O., Voorhees, William D. III
• Application Number:
  US11/410,354
• Publication Number:
  US 20060195176A1
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/088 : Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• 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 33/022 : Metal or alloys
• CPC Class Codes: A61N 5/1002 : Intraluminal radiation therapy
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: C08L 65/04 : Polyxylenes

Abstract

Bioactive-coated medical devices are provided, including coated vascular stents. The medical device coating can include a coating layer posited over at least a portion of the medical device surface, and can include a butyl methacrylate polymer or an ethylene-vinyl acetate copolymer in combination with a bioactive material that can function as both an immunosuppressive agent and an antiproliferative agent. Optionally, multilayer coatings can further include an adhesion promoting layer comprising parylene positioned between the coating layer and the medical device surface, a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer, or both. The coating layer preferably comprises between about 0.5 and 2.0 μg/mm² of the bioactive material on the outer surface of the medical device. The bioactive material can be absorbed into the coating layer, which can have a thickness of between about 0.5 μm to about 5 μm.

Claims

1. A coated medical device, comprising:

a structure adapted for introduction into a patient, the structure having at least one surface;

a coating layer posited over the at least one surface of the structure, the coating layer comprising an ethylene-vinyl acetate copolymer and a bioactive material, the bioactive material comprising an immunosuppressive agent.

2. The coated medical device of claim 1, wherein the bioactive material is both an immunosuppressive agent and an antiproliferative agent.

3. The coated medical device of claim 1, wherein the coating layer further comprises butyl methacrylate.

4. The coated medical device of claim 1, wherein the coating layer comprises between about 1-5 μ

g/mm² of the bioactive material on the surface.

5. The coated medical device of claim 1, wherein the bioactive material is absorbed into the coating layer.

6. The coated medical device of claim 1, wherein the coating layer has a thickness of between about 0.5 μ

m to about 5 μ

m.

7. The coated medical device of claim 1, wherein the structure is a vascular stent comprising a biocompatible metal.

8. The coated medical device of claim 1, wherein the structure is a vascular stent comprising stainless steel and having an outer surface and a lumen surface;

wherein the at least one surface contacting the coating layer is the outer surface of the vascular stent; and

wherein the coating layer comprises between about 0.5 and 2.0 μ

g/mm² of the bioactive material in the coating layer posited on the outer surface.

9. The coated medical device of claim 1, wherein the coated medical device further comprises an adhesion promoting layer comprising parylene positioned between the coating layer and the at least one surface of the structure.

10. The coated medical device of claim 1, wherein the coated medical device further comprises a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer.

11. The coated medical device of claim 1, wherein the coated medical device further comprises:

an adhesion promoting layer comprising parylene positioned between the coating layer and the at least one surface of the structure; and

a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer; and

wherein the structure is configured as a vascular stent having a stainless steel outer surface in contact with the adhesion promoting layer, at least a portion of the coating layer is positioned in contact with the adhesion promoting layer and the porous layer, the coating layer comprising an ethylene-vinyl acetate copolymer and a butyl methacrylate polymer in contact with the bioactive agent, and the bioactive agent is both an immunosuppressive agent and an antiproliferative agent.

12. A coated medical device, comprising:

a structure adapted for introduction into a patient, the structure having at least one surface;

a coating layer posited over the at least one surface of the structure, the coating layer comprising a butyl methacrylate polymer and a bioactive material that is both an immunosuppressive agent and an antiproliferative agent.

13. The coated medical device of claim 12, wherein the coating layer further comprises an ethylene-vinyl acetate copolymer.

14. The coated medical device of claim 12, wherein the coating layer comprises between about 0.5 and 2.0 μ

g/mm² of the bioactive material on the at least one surface.

15. The coated medical device of claim 12, wherein the coated medical device further comprises an adhesion promoting layer comprising parylene positioned between the coating layer and the at least one surface of the structure.

16. The coated medical device of claim 12, wherein the coated medical device further comprises a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer.

17. A coated vascular stent, comprising:

a vascular stent adapted for introduction into a patient, the structure having an outer surface and a lumen surface;

an adhesion promoting layer comprising parylene positioned between the coating layer and the outer surface;

a coating layer posited over at least a portion of the adhesion promoting layer, the coating layer comprising a butyl methacrylate polymer, an ethylene-vinyl acetate copolymer and a bioactive material that is both an immunosuppressive agent and an antiproliferative agent; and

a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer.

18. The coated vascular stent of claim 17, wherein the coating layer comprises between about 0.5 and 2.0 μ

g/mm² of the bioactive material on the outer surface of the coated vascular stent.

19. The coated medical device of claim 17, wherein the bioactive material is absorbed into the coating layer.

20. The coated medical device of claim 17, wherein the coating layer has a thickness of between about 0.5 μ

m to about 5 μ

m.