Medical device with a porous surface for delivery of a therapeutic agent

• US 8,070,797 B2
• Filed: 02/27/2008
• Issued: 12/06/2011
• Est. Priority Date: 03/01/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Flanagan, Aiden, McMorrow, David, Malone, Anthony, O'Connor, Tim
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Woznicki, Jacqueline
• Application Number:
  US12/072,666
• Publication Number:
  US 20080243231A1
• Time in Patent Office: 1,378 Days
• Field of Search: 623/1.34, 623/1.38, 623 142- 143, 623/1.46
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 31/082 Inorganic materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention is generally directed to implantable medical devices for delivering therapeutic agents to the body tissue of a patient and methods for making such medical devices. In particular, the present invention is directed to implantable medical devices, such as intravascular stents, having a surface that includes a plurality of cavities and a plurality of pores and a composition disposed in the pores and/or cavities, as well as, implantable medical devices, such as intravascular stents, having a surface that has a coating composition disposed on the surface, wherein the coating composition includes a plurality of cavities and a plurality of pores and another coating composition disposed in the pores and/or cavities.

Claims

1. An implantable stent comprising:

a stent sidewall structure comprising

(a) a stent strut body having a surface defined by the stent strut body or by a surface coating on the stent strut body, the surface comprising a metal, a metal oxide, a ceramic oxide, or inert carbon;

(b) the surface defining a plurality of cavities therein, at least some of the cavities being in fluid communication with the surface and at least one cavity being defined by a cavity surface having a plurality of pores therein;

(c) a second coating composition comprising a first therapeutic agent, wherein the second coating composition is disposed within a portion of at least one of the cavities; and

(d) a cap disposed in the at least one of the cavities and covering the second coating composition, wherein the cap is within the at least one of the cavities and wherein at least some of the pores in the cavity surface being not covered by the cap and being in fluid communication with the surface,

thereby causing the first therapeutic agent to release through the pores to the surface and to not substantially release from the cavity directly to the surface.

2. The implantable stent of claim 1, wherein:

the stent sidewall structure comprises the stent strut body and the surface coating on the stent strut, the surface is a surface of the surface coating, and the cavities are defined by the surface coating.

3. The stent of claim 1, wherein the sidewall structure comprises a plurality of struts and openings in the sidewall structure.

4. The stent of claim 2, wherein the surface is on an abluminal side of the stent strut body.

5. The stent of claim 3, wherein the surface coating conforms to a surface of the stent strut body so that the openings of the stent sidewall structure are preserved, and wherein the surface of the sidewall structure comprises an abluminal surface.

6. The stent of claim 1, wherein the stent is an intravascular balloon-expandable stent.

7. The stent of claim 1, wherein the stent is an intravascular self-expanding stent.

8. The stent of claim 2, wherein the surface coating composition is radiopaque.

9. The stent of claim 2, wherein the surface coating composition is free of any polymer.

10. The stent of claim 2, wherein the pores are distributed throughout the surface coating.

11. The stent of claim 10, wherein the pores are homogenously distributed throughout the surface coating.

12. The stent of claim 1, wherein the second coating composition is also disposed within at least one of the pores.

13. The stent of claim 1, wherein the second coating composition further comprises a polymer.

14. The stent of claim 13, wherein the polymer is biostable.

15. The stent of claim 13, wherein the polymer is bioabsorbable.

16. The stent of claim 13, wherein the polymer comprises styrene-isobutylene-styrene, polylactic-co-glycolic acid (PLGA), polybutyl methacrylate (PBMA), polyvinylidene fluoride (PVDF), or a combination thereof.

17. The stent of claim 1, wherein the metal oxide or ceramic oxide comprises iridium oxide, titanium oxide, titanium dioxide, iron oxide, hydroxyapatite, calcium phosphates, alumina, zirconia, zirconium, silica based glasses, or a combination thereof.

18. The stent of claim 1, wherein the metal comprises gold, tantalum, platinum, titanium, Nitinol or a combination thereof.

19. The stent of claim 1, wherein the surface coating is about 1 micron to about 30 microns thick.

20. The stent of claim 1, wherein the diameter of the pores is less than or equal to one micron.

21. The stent of claim 1, wherein the width of the cavities is greater than or equal to one micron.

22. The stent of claim 1, wherein the stent sidewall structure further comprises a third coating composition comprising a second therapeutic agent and, wherein the third coating composition is disposed within the pores.

23. The stent of claim 22, wherein the first therapeutic agent and second therapeutic agent are different.

24. The stent of claim 1, wherein the first therapeutic agent comprises an anti-thrombogenic agent, anti-angiogenesis agent, anti-proliferative agent, antibiotic, anti-restenosis agent, growth factor, immunosuppressant, or radiochemical.

25. The stent of claim 1, wherein the first therapeutic agent comprises an anti-restenosis agent.

26. The stent of claim 1, wherein the first therapeutic agent comprises paclitaxel.

27. The stent of claim 1, wherein the first therapeutic agent comprises sirolimus, tacrolimus, pimecrolimus, zotarolimus, or everolimus.

28. The stent of claim 1, wherein the cap comprises a polymer.

29. The stent of claim 1, wherein the stent sidewall structure further comprises a third coating composition comprising a second therapeutic agent, wherein the third coating composition is disposed in at least some of the pores.

30. The stent of claim 29, wherein the first therapeutic agent and second therapeutic agent are different.

31. The stent of claim 29, wherein the third coating composition further comprises a polymer.

32. The implantable stent of claim 1, wherein the stent sidewall structure comprises the stent strut body and the surface is a surface of the stent strut body.

33. The stent of claim 32, wherein the surface of the stent strut body is an abluminal surface.

34. The stent of claim 32, wherein the pores are distributed throughout the stent strut body.

35. The stent of claim 32, wherein the pores are homogenously distributed throughout the stent strut body.

50. The implantable stent of claim 1, wherein the cap is within the at least one of the cavities and at least some of the pores in the cavity surface being not covered by the cap and being in fluid communication with the surface.

36. A method of coating an implantable stent having a stent sidewall structure, the stent sidewall structure comprising a stent strut body having a surface defined by the stent strut body or by a surface coating on the stent strut body, the surface coating comprising a surface coating composition comprising a metal, a metal oxide or a ceramic oxide, or inert carbon, the stent sidewall structure defining a plurality of pores therein and, the method comprising:

(a) creating a plurality of cavities in the surface, wherein the cavities have a cavity surface and wherein at least some of the pores are in fluid communication with a portion of the cavity surface;

(b) disposing a second composition comprising a first therapeutic agent within a portion of at least one of the cavities; and

(c) forming a cap in the at least one of the cavities to cover the second coating composition, wherein the cap is within the at least one of the cavities and wherein at least some of the pores in the cavity surface being not covered by the cap and being in fluid communication with the surface,

thereby causing the first therapeutic agent to release through the pores to the surface and to not substantially release from the cavity directly to the surface.

37. The method of claim 36, wherein the stent sidewall structure comprises the stent strut body with the surface coating and the cavities are created in the surface coating composition.

38. The method of claim 36, further comprising disposing the second coating composition within at least some of the pores.

39. The method of claim 37, further comprising disposing a third coating composition within at least some of the pores, wherein the third coating composition comprises a second therapeutic agent.

40. The method of claim 36, wherein the cap comprises a polymer.

41. The method of claim 36, wherein the second coating composition further comprises a polymer.

42. The method of claim 36, wherein the cavities are created by laser ablation, drilling, chemical etching or a combination thereof.

43. The method of claim 36, further comprising disposing a third coating composition within at least some of the pores, wherein the third coating composition comprises a second therapeutic agent.

44. The method of claim 36, wherein the surface of the stent sidewall structure is a surface of the stent strut body, the pores are defined in the stent strut body, and the cavities are created in the stent strut body.

45. A method of coating an implantable stent having a stent sidewall structure, the stent sidewall structure comprising a strut and a surface coating comprising a surface coating composition comprising a metal, a metal oxide or a ceramic oxide, or inert carbon, the method comprising:

(a) creating a plurality of cavities in the metal or ceramic oxide or inert carbon, wherein the cavities have a cavity surface;

(b) creating a plurality of pores in the metal or ceramic oxide or inert carbon and wherein at least some of the pores are in fluid communication with a portion of the cavity surface; and

(c) disposing a second composition comprising a first therapeutic agent within a portion of at least one of the cavities; and

(d) forming a cap in the at least one of the cavities to cover the second coating composition, wherein the cap is within the at least one of the cavities and wherein at least some of the pores in the cavity surface being not covered by the cap and being in fluid communication with the surface,

thereby causing the first therapeutic agent to release through the pores to the surface and to not substantially release from the cavity directly to the surface.

46. The method of claim 45, further comprising disposing the second composition within at least some of the pores.

47. The method of claim 45, further comprising disposing a third coating composition within at least some of the pores, wherein the third coating composition comprises a second therapeutic agent.

48. The method of claim 45, wherein the cap comprises a polymer.

49. The method of claim 45, wherein the cavities are formed by laser ablation, drilling, chemical etching or a combination thereof.