Medical devices having vapor deposited nanoporous coatings for controlled therapeutic agent delivery

• US 20060127443A1
• Filed: 12/09/2004
• Published: 06/15/2006
• Est. Priority Date: 12/09/2004
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Helmus, Michael N.
• Application Number:
  US11/007,877
• Publication Number:
  US 20060127443A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/28 Materials for coating prostheses
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites

Abstract

The present invention is directed to medical devices which comprise the following: (a) an underlying region that comprises a therapeutic agent and (b) a vapor deposited nanoporous coating (e.g., a polymeric, ceramic or metallic nanoporous coating) over the underlying region, which regulates the release of the therapeutic agent from the medical device when it is placed into a subject.

Claims

1. A medical device comprising (a) an underlying region that comprises a therapeutic agent and (b) a vapor deposited nanoporous coating over said underlying region, said vapor deposited nanoporous coating regulating the release of said therapeutic agent from said medical device when placed into a subject.

2. The medical device of claim 1, wherein said vapor deposited nanoporous coating is a polymeric coating.

3. The medical device of claim 1, wherein said vapor deposited nanoporous coating is a ceramic coating.

4. The medical device of claim 1, wherein said vapor deposited nanoporous coating is a metallic coating.

5. The medical device of claim 1, wherein said nanoporous coating is deposited by physical vapor deposition.

6. The medical device of claim 1, wherein said nanoporous coating is deposited by chemical vapor deposition.

7. The medical device of claim 1, wherein said nanoporous coating is deposited by plasma enhanced chemical vapor deposition.

8. The medical device of claim 7, wherein said nanoporous coating is a silicon oxide coating.

9. The medical device of claim 8, wherein said silicon oxide coating is a silicon oxycarbide coating.

10. The medical device of claim 9, wherein said silicon oxycarbide coating is a hydrogenated silicon oxycarbide coating.

11. The medical device of claim 1, wherein said nanoporous coating is deposited by pyrolytic chemical vapor deposition.

12. The medical device of claim 11, wherein said nanoporous coating comprises a fluorocarbon polymer or copolymer.

13. The medical device of claim 11, wherein said nanoporous coating comprises a silicone polymer or copolymer.

14. The medical device of claim 11, wherein said nanoporous coating comprises a polymer or copolymer formed from one or more addition-polymerizable unsaturated monomers.

15. The medical device of claim 1, wherein said release is zero order release.

16. The medical device of claim 1, wherein said underlying region comprises a plurality of different therapeutic agents.

17. The medical device of claim 1, wherein said underlying region comprises a therapeutic agent dispersed within a support region.

18. The medical device of claim 17, wherein said support region comprises a polymer.

19. The medical device of claim 1, wherein said underlying region comprises (a) a therapeutic-agent-containing coating comprising a therapeutic agent disposed over (b) an underlying support region.

20. The medical device of claim 19, wherein said therapeutic-agent-containing coating comprises said therapeutic agent and a polymer.

21. The medical device of claim 19, wherein said therapeutic-agent-containing coating consists essentially of said therapeutic agent.

22. The medical device of claim 19, wherein said underlying support region is a metallic support region.

23. The medical device of claim 1, wherein the lateral dimensions of said interconnected nanopores approach the hydrated radius of said therapeutic agent.

24. The medical device of claim 1, wherein said medical device comprises a plurality of distinct nanoporous coating regions.

25. The medical device of claim 1, wherein said medical device comprises a plurality of distinct underlying regions.

26. The medical device of claim 1, wherein said medical device is an implantable or insertable medical device.

27. The medical device of claim 26, wherein said implantable or insertable medical device is selected from catheters, guide wires, filters, stents, vascular grafts, endografts, embolic coils, heart valves, joint prostheses, bone plates and rods, dental implants, buccal implants, urterine slings, sutures, ligatures, and soft tissue reconstruction implants.

28. The medical device of claim 26, wherein said medical device is adapted for implantation or insertion into the coronary vasculature, peripheral vascular system, esophagus, trachea, colon, biliary tract, urogenital system, or brain.

29. The medical device of claim 1, 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.

30. The medical device of claim 1, wherein said device is an implantable or insertable tubular medical device that comprises a first underlying region comprising a first therapeutic agent on its inner luminal surface and a second underlying region comprising a second therapeutic agent that differs from said first biologically active agent on its outer abluminal surface.

31. The medical device of claim 30, wherein said device is a vascular stent and wherein said first biologically active agent is an antithrombotic agent and wherein said second biologically active agent is an antiproliferative agent.

32. The medical device of claim 1, wherein the vapor deposited nanoporous coating is patterned.

33. The medical device of claim 1, wherein said device is an implantable or insertable tubular medical device, and wherein the vapor deposited nanoporous coating is provided only on the inner luminal surface of the device, only on the outer abluminal surface of the device, or only on the edges between the luminal and abluminal surfaces of the device.