Medical devices having biodegradable polymeric regions with overlying hard, thin layers

• US 20080069858A1
• Filed: 08/10/2007
• Published: 03/20/2008
• Est. Priority Date: 09/20/2006
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Weber, Jan
• Application Number:
  US11/891,588
• Publication Number:
  US 20080069858A1
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61L 31/084 Carbon; Graphite
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• 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

Abstract

Implantable or insertable medical devices comprising a biodegradable polymeric region and a hard, thin layer disposed over the biodegradable polymeric region are described. Also described are methods for creating the same.

Claims

1. An implantable or insertable medical device comprising a biodegradable polymeric region and a hard, thin biostable layer disposed over said biodegradable polymeric region.

2. The implantable or insertable medical device of claim 1, wherein said medical device is a vascular medical device.

3. The implantable or insertable medical device of claim 1, wherein said medical device is selected from a stent and a sealing device.

4. The implantable or insertable medical device of claim 1, wherein said medical device comprises a tubular portion.

5. The implantable or insertable medical device of claim 1, wherein said biodegradable polymeric region comprises a tubular body and wherein said hard, thin biostable layer covers either the inside surface or the outside surface of said tubular body.

6. The implantable or insertable medical device of claim 1, wherein said biodegradable polymeric region comprises a tubular body and wherein said hard, thin biostable layer covers both the inside surface and the outside surface of said tubular body.

7. The implantable or insertable medical device of claim 1, wherein said device further comprises a substrate and wherein said biodegradable polymeric region is disposed over said substrate.

8. The implantable or insertable medical device of claim 7, wherein said substrate is a metallic substrate.

9. The implantable or insertable medical device of claim 7, wherein a plurality of said biodegradable polymeric regions are disposed over said substrate.

10. The implantable or insertable medical device of claim 1, wherein said hard, thin biostable layer is less than 1 μ

m in thickness.

11. The implantable or insertable medical device of claim 1, wherein said hard, thin biostable layer is less than 250 nm in thickness.

12. The implantable or insertable medical device of claim 1, wherein said hard, thin biostable layer has a surface Young'"'"'s modulus ranging from 50 MPa 1 GPa.

13. The implantable or insertable medical device of claim 1, wherein said hard, thin biostable layer has a surface Young'"'"'s modulus ranging from 10 GPa to about 90 GPa.

14. The implantable or insertable medical device of claim 1, wherein said hard, thin biostable layer is provided with a plurality of apertures.

15. The implantable or insertable medical device of claim 14, wherein said apertures are 1 μ

m² or less in area.

16. The implantable or insertable medical device of claim 1, wherein said hard, thin biostable layer comprises a material selected from metals, metal oxides, metal nitrides, metal carbides, metal carbonitrides, and combinations thereof.

17. The implantable or insertable medical device of claim 1, wherein said hard, thin biostable layer is a diamond-like carbon layer.

18. The implantable or insertable medical device of claim 17, wherein said diamond-like carbon layer comprises an sp³ fraction of 50% or more.

19. The implantable or insertable medical device of claim 17, wherein said diamond-like carbon layer comprises vapor deposited carbon.

20. The implantable or insertable medical device of claim 17, wherein said diamond-like carbon layer is formed from carbon atoms in said biodegradable polymer region.

21. The implantable or insertable medical device of claim 1, wherein said hard, thin biostable layer is a vapor deposited layer.

22. The implantable or insertable medical device of claim 1, wherein at least 90% of said biodegradable polymer is degraded after the device is implanted or inserted for 12 weeks in vivo.

23. The implantable or insertable medical device of claim 1, wherein said biodegradable polymer region comprises a polymer selected from polyester homopolymers and copolymers, polyanhydride homopolymers and copolymers, amino-acid-based homopolymers and copolymers, and combination thereof.

24. The implantable or insertable medical device of claim 1, further comprising a therapeutic agent.

25. The implantable or insertable medical device of claim 24, wherein said therapeutic agent is disposed within said biodegradable polymeric region.

26. The implantable or insertable medical device of claim 24, wherein said therapeutic agent is selected from one or more of the group consisting of anti-thrombotic agents, anti-proliferative agents, anti-inflammatory agents, anti-migratory agents, agents affecting extracellular matrix production and organization, antineoplastic agents, anti-mitotic agents, anesthetic agents, anti-coagulants, vascular cell growth promoters, vascular cell growth inhibitors, cholesterol-lowering agents, vasodilating agents, TGF-β

elevating agents, and agents that interfere with endogenous vasoactive mechanisms.

27. The implantable or insertable medical device of claim 1, further comprising a plurality of therapeutic agents.

28. A stent comprising a biodegradable polymeric region and a hard, thin layer having a surface Young'"'"'s modulus ranging from 100 MPa to 300 MPa.