Coated medical devices for abluminal drug delivery

• US 20080241218A1
• Filed: 02/27/2008
• Published: 10/02/2008
• Est. Priority Date: 03/01/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Malone, Anthony, O'Connor, Tim, Flanagan, Aiden, McMorrow, David, Heaney, Barry
• Granted Patent: US 8,431,149 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61P 7/00 Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

The invention relates generally to an implantable medical device for delivering a therapeutic agent to the body tissue of a patient, and a method for making such a medical device. In particular, the invention pertains to an implantable stent, such as an intravascular stent, having a coating comprising an inorganic or ceramic oxide, metal or inert carbon and a plurality of reservoirs in such material that contain a therapeutic agent.

Claims

1. An implantable stent comprising:

(a) a tubular stent sidewall structure having an abluminal surface and an adluminal surface;

(b) a coating having an outer surface comprising;

(i) a first coating material disposed on at least a portion of the abluminal surface of the stent comprising an inorganic or ceramic oxide, metal or inert carbon;

(ii) a plurality of reservoirs formed within the first coating material; and

(iii) a second coating material comprising a polymer and a first therapeutic agent, wherein the second coating material is disposed within the reservoirs.

2. The stent of claim 1, wherein the adluminal surface of the stent is substantially free of the coating.

3. The stent of claim 1, wherein the sidewall structure comprises a plurality of struts and openings in the sidewall structure, and wherein at least one strut comprises an abluminal surface and an adluminal surface opposite the abluminal surface.

4. The stent of claim 1, wherein the coating conforms to the stent sidewall structure so that the openings are preserved.

5. The stent of claim 1, wherein the first coating material is further disposed on the adluminal surface of the sidewall structure and wherein the first coating material disposed on the adluminal surface of the sidewall structure comprises a plurality of reservoirs.

6. The stent of claim 1, wherein the inorganic or ceramic oxide comprises iridium oxide.

7. The stent of claim 1, wherein the metal comprises gold, platinum or titanium.

8. The stent of claim 1, wherein the coating is about 1 micron to about 70 microns thick.

9. The stent of claim 1, wherein the first coating material further comprises a second therapeutic agent and wherein the first therapeutic agent and second therapeutic agent are different.

10. The stent of claim 1, wherein the reservoirs are interconnected.

11. The stent of claim 1, wherein the reservoirs are in fluid communication with the outer surface of the coating.

12. The stent of claim 1, wherein the reservoirs extend between the outer surface of the coating and the abluminal surface of the stent.

13. The stent of claim 1, wherein the average diameter of the reservoirs is about 5 microns to about 80 microns.

14. The stent of claim 1, wherein the polymer is biostable.

15. The stent of claim 1, wherein the polymer is bioabsorbable

16. The stent of claim 1, polymer comprises a styrene-isobutylene copolymer, polylactic glycol acid, and methylenebisacrylamide.

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

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

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

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

21. An intravascular stent comprising:

(a) a tubular stent sidewall structure having an abluminal surface and an adluminal surface wherein, the sidewall structure has a plurality of openings therein;

(b) a coating comprising;

(i) a first coating material comprising gold or platinum disposed on the abluminal surface;

(ii) a plurality of reservoirs formed within the first coating material; and

(iii) a second coating material comprising a polymer and an anti-restinosis agent, wherein the second coating material is disposed with in the reservoirs.

22. A stent comprising:

(a) a tubular stent sidewall structure comprising a plurality of struts and openings in the sidewall structure, and wherein at least one strut comprises an abluminal surface and an adluminal surface opposite the abluminal surface;

(b) a coating having an outer surface comprising;

(i) a first coating material disposed on at least a portion of the abluminal surface comprising gold or platinum;

(ii) a plurality of reservoirs formed within the first coating material; and

(iii) a second coating material comprising a polymer and an anti-restenosis agent, wherein the second coating material is disposed within the reservoirs.