Coated implantable medical device

• US 7,811,622 B2
• Filed: 10/31/2007
• Issued: 10/12/2010
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• 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
• Primary Examiner(s): Meeks; Timothy H
• Assistant Examiner(s): Sellman; Cachet I
• Application Number:
  US11/931,603
• Publication Number:
  US 20080145396A1
• Time in Patent Office: 1,077 Days
• Field of Search: 427/2.1, 427/2.24, 427/2.25, 604/264, 604/265, 604/266, 604/509, 604/103.02
• US Class Current: 427/2.1
• 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

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Claims

1. A method of preparing a catheter having a portion for performing percutaneous transluminal angioplasty, wherein said portion has a drug coating, the method comprising:

mixing at least one drug with a volatile fluid to create a drug mixture; and

applying said drug mixture to at least part of an exterior surface of said portion, wherein said portion is a balloon.

2. The method of claim 1, wherein said drug mixture is applied by dipping, rolling, spraying, or brushing.

3. The method of claim 1, wherein said drug mixture is applied in multiple application steps.

4. The method of claim 1, further comprising the step of evaporating said volatile fluid from said drug mixture after applying said drug mixture.

5. The method of claim 1, wherein said at least one drug comprises paclitaxel.

6. A method of preparing a catheter having a portion for performing percutaneous transluminal angioplasty, wherein said portion has a drug coating, the method comprising:

mixing at least one drug with a volatile fluid to create a drug mixture,

applying said drug mixture to at least part of an exterior surface of said portion, and coating at least part of the exterior surface of said portion with a polymer to form a polymer coating prior to applying said drug mixture to at least a part of the exterior surface of said portion.

7. The method of claim 6, wherein said applying comprises applying said drug mixture to said polymer coating, and further comprising the step of evaporating said volatile fluid from said polymer coating after applying said drug mixture.

8. The method of claim 7, further comprising the step of applying a modifying or modulating layer after evaporating said volatile fluid.

9. The method of claim 8, wherein the modifying or modulating layer has a thickness of about 5000 Angstroms to 250,000 Angstroms.

10. The method of claim 9, wherein the modifying or modulating layer has a thickness of about 5000 Angstroms.

11. The method of claim 8, wherein said modifying or modulating layer comprises a polymer.

12. The method of claim 8, wherein said modifying or modulating layer comprises a drug.

13. The method of claim 7, wherein said polymer coating has a thickness of between about 50,000 and 500,000 Angstroms.

14. The method of claim 13, wherein said polymer coating has a thickness of about 50,000 Angstroms.

15. The method of claim 6, further comprising the step of evaporating said volatile fluid form said drug mixture after applying said drug mixture.

16. The method of claim 6, wherein said at least one drug comprises paclitaxel.

17. A method of preparing a catheter having a portion for performing percutaneous transluminal angioplasty, wherein said portion has a drug coating, the method comprising:

mixing at least one drug with a volatile fluid to create a drug mixture; and

applying said drug mixture to at least part of an exterior surface of said portion, wherein the volatile fluid is ethanol.

18. The method of claim 17, wherein said at least one drug comprises paclitaxel.

19. A method of preparing a catheter having a portion for performing percutaneous transluminal angioplasty, wherein said portion has a drug coating, the method comprising:

mixing at least one drug with a volatile fluid to create a drug mixture; and

applying said drug mixture to at least part of an exterior surface of said portion, wherein said at least one drug is paclitaxel.

20. A method of preparing a catheter having a portion for performing percutaneous transluminal angioplasty, wherein said portion has a drug coating, the method comprising:

mixing at least one drug with a volatile fluid to create a drug mixture; and

applying said drug mixture to at least part of an exterior surface of said portion, wherein said at least one drug comprises a combination of paclitaxel and an agent selected from the group consisting of anticoagulants, antimitotics, antithrombogenics, thrombolytics, antiinflammatory agents, nitric oxide, nitric oxide promoter, and growth factors.

21. A method of preparing a balloon catheter having a balloon with a substantially water-insoluble drug coating, comprising:

a catheter for insertion into a body lumen, having a shaft and an expandable balloon at a distal end of the shaft, said balloon having a polymer coating on at least a portion of an exterior surface, said polymer coating having a thickness of between about 0.5 and 50 microns, said polymer coating containing at least one substantially water-insoluble drug, said method comprising the steps of;

dissolving said at least one substantially water-insoluble drug in an organic solvent to create a drug solution; and

applying said drug solution to at least a portion of the exterior surface of said balloon.

23. The method of claim 21, wherein said at least one drug comprises paclitaxel.

24. The method of claim 21, wherein said organic solvent comprises ethanol.

22. The method of claimed 21, wherein said polymer coating has a thickness of about 5 microns.

25. A method of preparing a catheter with a drug coating comprising:

dissolving at least one drug in an organic solvent to create a drug solution; and

applying said drug solution to at least a portion of an exterior surface of the catheter, wherein said catheter is a balloon catheter, and said portion of said exterior surface is a portion of the exterior surface of the balloon.

26. The method of claim 25, wherein said drug is a water-insoluble drug.

27. The method of claim 25, wherein said drug is a substantially water-insoluble drug. thickness of about 50,000 Angstroms.

28. The method of claim 27, further comprising the step of evaporating said organic solvent from said drug solution after applying said drug solution.

29. The method of claim 25, wherein said drug solution is applied by dipping, rolling, spraying, or brushing.

30. The method of claim 25, wherein said drug solution is applied in multiple application steps.

31. The method of claim 25, further comprising the step of evaporating said organic solvent from said drug solution after applying said drug solution.

32. The method of claim 25, wherein said at least one drug comprises paclitaxel.

33. A method of preparing a catheter with a drug coating comprising:

dissolving at least one drug in an organic solvent to create a drug solution; and

applying said drug solution to at least a portion of an exterior surface of the catheter, further comprising the step of coating at least part of the exterior surface of said portion with a polymer to form a polymer coating prior to applying said drug solution to at least a part of the exterior surface of said portion.

34. The method of claim 33, wherein said applying comprises applying said drug mixture to said polymer coating, and further comprising the step of evaporating said organic solvent from said polymer coating after applying said drug solution.

35. The method of claim 34, further comprising the step of applying a modifying or modulating layer after evaporating said organic solvent.

36. The method of claim 35, wherein said modifying or modulating layer comprises a polymer.

37. The method of claim 35, wherein said modifying or modulating layer comprises a drug.

38. The method of claim 35, wherein the modifying or modulating layer has a thickness of about 5000 Angstroms to 250,000 Angstroms.

39. The method of claim 38, wherein the modifying or modulating layer has a thickness of about 5000 Angstroms.

40. The method of claim 33, wherein said polymer coating has a thickness of between about 50,000 and 500,000 Angstroms.

41. The method of claim 33, wherein said polymer coating has a thickness of about 50,000 Angstroms.

42. A method of preparing a catheter with a drug coating comprising:

dissolving at least one drug in an organic solvent to create a drug solution; and

applying said drug solution to at least a portion of an exterior surface of the catheter, wherein the organic solvent is ethanol.

45. The method of claim 42, wherein said at least one drug comprises paclitaxel.

43. A method of preparing a catheter with a drug coating comprising:

dissolving at least one drug in an organic solvent to create a drug solution; and

applying said drug solution to at least a portion of an exterior surface of the catheter, wherein said at least one drug is paclitaxel.

44. A method of preparing a catheter with a drug coating comprising:

dissolving at least one drug in an organic solvent to create a drug solution; and

applying said drug solution to at least a portion of an exterior surface of the catheter, wherein said at least one water-insoluble drug comprises a combination of paclitaxel and an agent selected from the group consisting of anticoagulants, antimitotics, antithrombogenics, thrombolytics, anti-inflammatory agents, nitric oxide, nitric oxide promoter, and growth factors.