Medical devices containing therapeutic agents

Patent metadata

Field	Value
Publication number	US-9533078-B2
Application number	US-200913000594-A
Country	US
Kind code	B2
Filing date	Jun 19, 2009
Priority date	Jun 25, 2008
Publication date	Jan 3, 2017
Grant date	Jan 3, 2017

Abstract

The present invention pertains to implantable or insertable medical devices which comprise a substrate and one or more therapeutic-agent-containing regions contain one or more therapeutic agents. In various aspects of the invention, one or more characteristics of such therapeutic-agent-containing regions are controlled. Further aspects of the invention relate to methods of forming such devices and to methods of using such devices.

First claim

The invention claimed is:

1. A medical device comprising an inorganic substrate, a discontinuous layer of therapeutic-agent containing material that comprises a therapeutic agent, said discontinuous layer comprising a first area corresponding to a plurality of regions of said therapeutic-agent-containing material which cover the substrate and a second area which does not cover the substrate, and an inorganic nanoporous layer disposed over the therapeutic-agent-containing layer, said inorganic nanoporous layer being in contact with said therapeutic-agent-containing material in said first area and in contact with said substrate in said second area, wherein said regions of said therapeutic-agent-containing material are not disposed within depressions in the surface of a substrate, and wherein said regions of said therapeutic-agent-containing material are in the form of discrete flattened particles.

2. The medical device of claim 1 , wherein 75 wt % or more said flattened particles have a contact angle with the substrate that is less than 90°.

3. The medical device of claim 1 , wherein said flattened particles are formed by a process in which particles of said therapeutic-agent-containing material are exposed to a vapor that comprises a solvent within which the particles are soluble under conditions such that the solvent wets the particles.

4. The medical device of claim 3 , wherein the therapeutic-agent-containing material comprises at least 95% therapeutic agent.

5. The medical device of claim 3 , wherein the medical device substrate is a balloon or a stent and wherein the therapeutic-agent-containing particles comprise an anti-restenotic agent.

6. The medical device of claim 5 , wherein said medical device is a stent.

7. The medical device of claim 6 , wherein said substrate is selected from titanium and its alloys, iron and its alloys, magnesium and its alloys, stainless steel and nitinol and wherein said inorganic nanoporous layer comprises a metal selected from tantalum, iron, magnesium, calcium, platinum, gold and combinations thereof.

8. The medical device of claim 6 , wherein said discontinuous layer and said nanoporous layer are disposed over an abluminal surface of the stent but are not disposed over a luminal surface of the stent.

9. The medical device of claim 3 , wherein 100% of particles are less than 100 micrometer in length and width.

10. The medical device of claim 3 , wherein 90% of the particles are less than 20 micrometer in length and width.

11. The medical device of claim 1 , wherein the therapeutic-agent-containing material comprises at least 95% therapeutic agent.

12. The medical device of claim 1 , wherein the medical device substrate is a balloon or a stent and wherein the therapeutic-agent-containing particles comprise an anti-restenotic agent.

13. The medical device of claim 12 , wherein said medical device is a stent.

14. The medical device of claim 13 , wherein said substrate is selected from titanium and its alloys, iron and its alloys, magnesium and its alloys, stainless steel and nitinol and wherein said inorganic nanoporous layer comprises a metal selected from tantalum, iron, magnesium, calcium, platinum, gold and combinations thereof.

15. The medical device of claim 13 , wherein said discontinuous layer and said nanoporous layer are disposed over an abluminal surface of the stent but are not disposed over a luminal surface of the stent.

16. The medical device of claim 1 , wherein 100% of particles are less than 100 micrometer in length and width.

17. The medical device of claim 1 , wherein 90% of the particles are less than 20 micrometer in length and width.

18. A medical device comprising an inorganic substrate, a discontinuous layer of therapeutic-agent containing material that comprises a therapeutic agent, said discontinuous layer comprising a first area corresponding to a plurality of regions of said therapeutic-agent-containing material which cover the substrate and a second area which does not cover the substrate, and an inorganic nanoporous layer disposed over the therapeutic-agent-containing layer, said inorganic nanoporous layer being in contact with said therapeutic-agent-containing material in said first area and in contact with said substrate in said second area, wherein said regions of said therapeutic-agent-containing material are not disposed within depressions in the surface of a substrate, and wherein said regions of said therapeutic-agent-containing material include a first region in which said therapeutic-agent-containing material is in the form of discrete spherical particles, and a second region in which said therapeutic-agent-containing material is in the form of discrete flattened particles.

19. The medical device of claim 18 , wherein the therapeutic-agent-containing material comprises at least 95% therapeutic agent.

20. The medical device of claim 18 , wherein the medical device substrate is a balloon or a stent and wherein the therapeutic-agent-containing particles comprise an anti-restenotic agent.

21. The medical device of claim 20 , wherein said medical device is a stent.

22. The medical device of claim 21 , wherein said substrate is selected from titanium and its alloys, iron and its alloys, magnesium and its alloys, stainless steel and nitinol and wherein said inorganic nanoporous layer comprises a metal selected from tantalum, iron, magnesium, calcium, platinum, gold and combinations thereof.

23. The medical device of claim 21 , wherein said discontinuous layer and said nanoporous layer are disposed over an abluminal surface of the stent but are not disposed over a luminal surface of the stent.

24. The medical device of claim 18 , wherein 100% of particles are less than 100 micrometer in length and width.

25. The medical device of claim 18 , wherein 90% of the particles are less than 20 micrometer in length and width.

Assignees

• Clarke John
• O'Connor Tim
• O'Brien Barry J
• Mcmorrow David
• Weber Jan
• Flanagan Aiden
• Boston Scient Scimed Inc

Inventors

• Clarke John
• O'Connor Tim
• O'Brien Barry J
• Mcmorrow David
• Weber Jan
• Flanagan Aiden

Classifications

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title

• A61F2250/0014

  having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis · CPC title

• A61L27/30

  Inorganic materials · CPC title

• A61L31/082

  Inorganic materials · CPC title

• A61L29/16

  Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} · CPC title